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As filed with the Securities and Exchange Commission on January 19, 2021.

Registration No. 333-          

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

Decipher Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   8071   98-1205079

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification Number)

6925 Lusk Boulevard, Suite 200

San Diego, CA 92121

(888) 975-4540

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

 

Tina S. Nova, Ph.D.

President and Chief Executive Officer

Decipher Biosciences, Inc.

6925 Lusk Boulevard, Suite 200

San Diego, CA 92121

(888) 975-4540

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

 

Charles J. Bair

Charles S. Kim

Cooley LLP

4401 Eastgate Mall

San Diego, CA 92121

(858) 550-6000

 

Cheston J. Larson

Matthew T. Bush

Anthony Gostanian

Latham & Watkins LLP

12670 High Bluff Drive

San Diego, CA 92130

(858) 523-5400

 

 

Approximate date of commencement of proposed sale to the public:

As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box.  ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer      Accelerated filer  
Non-accelerated filer      Smaller reporting company  
     Emerging growth company  

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

 

 

CALCULATION OF REGISTRATION FEE

 

 

Title of Each Class of Securities to be Registered  

Proposed

Maximum
Aggregate

Offering Price(1)

 

Amount of
Registration

Fee(2)

Common stock, $0.0001 par value per share

  $100,000,000   $10,910

 

 

(1)

Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(o) under the Securities Act of 1933, as amended. Includes the aggregate offering price of additional shares that the underwriters have the option to purchase.

(2)

Calculated pursuant to Rule 457(o) based on an estimate of the proposed maximum aggregate offering price.

 

 

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until this registration statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


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The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting offers to buy these securities in any state or other jurisdictions where the offer or sale is not permitted.

 

Subject to Completion, Dated January 19, 2021

                 Shares

 

LOGO

Common Stock

 

 

Decipher Biosciences, Inc. is offering                shares of its common stock. The initial public offering price of our common stock is expected to be between $              and $            per share. This is our initial public offering and no public market currently exists for our common stock. We have applied to list our common stock on the Nasdaq Global Market under the symbol “DECI.”

 

 

Investing in our common stock involves risks. See “Risk Factors” beginning on page 13 to read about factors you should consider before buying shares of our common stock.

We are an “emerging growth company” as defined under the U.S. federal securities laws and, as such, intend to comply with certain reduced public company reporting requirements for this and future filings.

 

     Per Share      Total  

Initial public offering price

    $                         $                    

Underwriting discounts and commissions(1)

    $                 $    

Proceeds, before expenses, to Decipher Biosciences, Inc.

    $                 $            

 

  (1)

We have agreed to reimburse the underwriters for certain expenses. We refer you to the section titled “Underwriting” for additional disclosure regarding total underwriting compensation.

The underwriters have an option to purchase a maximum of                  additional shares.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

Delivery of the shares of common stock is expected to be made on or about                  , 2021.

Joint Book-Running Managers

 

Evercore ISI   Wells Fargo Securities

Co-Managers

 

Canaccord Genuity   BTIG

The date of this prospectus is                 , 2021


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TABLE OF CONTENTS

 

Prospectus Summary

     1  

Risk Factors

     13  

Special Note Regarding Forward-Looking Statements

     68  

Market and Other Industry Data

     70  

Use of Proceeds

     71  

Dividend Policy

     73  

Capitalization

     74  

Dilution

     76  

Selected Consolidated Financial and Other Data

     79  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     82  

Business

     105  

Management

     162  

Executive and Director Compensation

     171  

Certain Relationships and Related Party Transactions

     188  

Principal Stockholders

     198  

Description of Capital Stock

     201  

Shares Eligible for Future Sale

     206  

Material U.S. Federal Income Tax Consequences to Non-U.S. Holders

     209  

Underwriting

     213  

Legal Matters

     220  

Experts

     220  

Change in Independent Accountant

     220  

Where You Can Find More Information

     221  

Index to Consolidated Financial Statements

     F-1  

 

 

We have not, and the underwriters have not, authorized anyone to provide any information or to make any representations other than those contained in this prospectus or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell only the shares offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus or in any applicable free writing prospectus is current only as of its date, regardless of its time of delivery or any sale of shares of our common stock. Our business, financial condition, results of operations and prospects may have changed since that date.

For investors outside the United States: We have not, and the underwriters have not, done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the shares of common stock and the distribution of this prospectus outside the United States.

Through and including                , 2021 (the 25th day after the date of this prospectus), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This delivery requirement is in addition to a dealer’s obligation to deliver a prospectus when acting as an underwriter and with respect to an unsold allotment or subscription.

 

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PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus and does not contain all of the information that you should consider in making your investment decision. Before investing in our common stock, you should carefully read this entire prospectus, including our consolidated financial statements and related notes included elsewhere in this prospectus and the information set forth under the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” Unless the context otherwise requires, we use the terms “Decipher Biosciences,” “the Company,” “we,” “us” and “our” in this prospectus to refer to Decipher Biosciences, Inc. and its wholly owned subsidiary, Decipher Corp., taken as a whole.

Overview

We are a commercial-stage precision oncology company committed to improving patient care, with a focus in urologic oncology specific to prostate and bladder cancers. Our novel prostate cancer genomic testing products, Decipher Biopsy and Decipher RP, provide valuable information about the underlying biology of a patient’s tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient’s entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Collectively, our genomic tests have been used by more than 3,200 urologists and radiation oncologists, and at all 28 National Comprehensive Cancer Network, or NCCN, centers in the United States. Our prostate cancer products are covered by Medicare in nine clinical indications, representing the entire known spectrum of localized, regional and biochemically recurrent prostate cancer. Six of our clinical indications received Medicare coverage in 2020. Our whole transcriptome analysis of clinical patient samples from our commercial channel and our participation in practice-changing clinical trials has allowed us to build and expand our Decipher GRID database, one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID is our proprietary engine that drives product development for us and our pharmaceutical partners.

Within the urologic cancer space, we are initially focused on prostate cancer, the most common cancer in men, with approximately 192,000 new cases per year and over 3.1 million men living with the disease in the United States alone. Once a patient is initially diagnosed with localized prostate cancer, in order to determine the appropriate patient management and therapy strategy, patients are stratified by their clinical risk with the goal of predicting the patient’s risk of metastasis and prostate cancer-related mortality. However, accurate risk stratification remains a critical unmet medical need in the management of prostate cancer, with current risk stratification methods generally being from 60% to 68% accurate in predicting metastasis. This low accuracy has resulted in patients being overtreated or undertreated, which in each case, has led to suboptimal care management strategies and deleterious outcomes for many patients.

Decipher Biopsy and Decipher RP report a score derived from our whole transcriptome analysis that provides patient risk estimates of prostate cancer-specific clinical outcomes. Both tests have repeatedly demonstrated superior accuracy to the most commonly used clinical risk stratification methods, such as NCCN risk groups. For example, in our primary clinical validation study involving over 6,900 patients, Decipher Biopsy, in combination with NCCN risk groups, demonstrated an 84% accuracy rate for predicting metastasis, compared to 68% for NCCN risk groups alone. Additionally, the reported Decipher Score is independent of clinical risk stratification methods. The addition of Decipher testing can help guide urologists, radiation oncologists, medical oncologists and pathologists to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes. For example, Decipher RP was studied in a Phase 3 randomized controlled trial, RTOG 96-01, where the Decipher Score became what we believe to be the first known test to be clinically validated for predicting distant metastases (p=0.003), prostate cancer-specific



 

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mortality (p<0.001), and overall survival (p=0.002) from localized prostate cancer. The strength of the clinical data supporting the use of the Decipher Score has led to Decipher’s inclusion in national guidelines. For example, in the 2020 NCCN Practice Guidelines for Prostate Cancer, the Decipher test is “recommended” for use to improve therapy decision making. Decipher is the only molecular diagnostic test that is currently recommended for use in patients with localized prostate cancer in the NCCN guidelines.

The following is an excerpt of a sample Decipher Biopsy test report.

 

 

LOGO

Our ability to capture and store the whole transcriptome profile from every patient sample (for Decipher Prostate and Decipher Bladder) combined with our participation in practice-changing prostate and bladder clinical trials have allowed us to build and expand our Decipher GRID genomic database. Our Decipher GRID genomic database contains over 90,000 urologic cancer transcriptomes matched to patient demographics and includes clinical trial outcome data. By collecting and comparing transcriptomes of different types of cells or tissues, we believe that researchers can gain a deeper understanding of what constitutes a specific cell type and how changes in transcriptional activity may reflect or contribute to disease.

We are leveraging Decipher GRID internally to expand our portfolio of innovative products. Additionally, we are partnering with investigators and pharmaceutical companies to identify patient populations which would benefit from earlier use of proprietary drugs or combination therapeutic strategies, or that are prime candidates for novel therapeutics. For example, we are currently supporting pharmaceutical companies in important clinical trials, including SPARTAN and TITAN, the pivotal clinical trials of apalutamide (ERLEADA), which has been approved by the U.S. Food and Drug Administration, or FDA, and is marketed by Janssen Pharmaceuticals, Inc., or Janssen, for the treatment of non-metastatic castrate resistant prostate cancer, or nmCRPC, and metastatic hormone sensitive prostate cancer, or mHSPC. In SPARTAN, the Decipher Score was validated for its ability to predict patients who would have increased risk of metastasis with the standard of care (Hazard Ratio = 0.43, p = 0.014; median 14.5 months vs. 22.1 months). In TITAN, Decipher High patients had an increased therapeutic



 

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benefit from treatment with ERLEADA over standard of care treatment as compared to the unselected patient population (Hazard Ratio = 0.40, p < 0.001 vs. Hazard Ratio = 0.48, p < 0.001). Importantly, both studies identified that patients with a high Decipher Score had a greater benefit when given ERLEADA compared to patients with a low Decipher Score. Similarly, we partnered with the Eastern Cooperative Oncology Group on the CHAARTED trial, the clinical trial which led to earlier use of docetaxel chemotherapy in patients with mHSPC, which has been approved by the FDA. In CHAARTED, a Decipher GRID molecular subtyping signature helped predict which prostate cancer patients diagnosed with mHSPC received more benefit from the addition of chemotherapy to Androgen Deprivation Therapy, or ADT, than from ADT alone. We are also supporting clinical trials being conducted by Astellas Pharma Inc., or Astellas, and Dendreon Pharmaceuticals LLC, or Dendreon, in localized prostate cancer.

We generated total revenue of $12.1 million, $16.5 million and $27.4 million for the years ended December 31, 2018 and 2019 and for the nine months ended September 30, 2020, respectively. We also incurred net losses of $29.9 million, $18.5 million and $3.4 million for the years ended December 31, 2018 and 2019 and for the nine months ended September 30, 2020, respectively.

Our Product Portfolio

The worldwide prostate cancer therapeutic market is one of the fastest growing cancer therapeutic markets of the decade and grew from approximately $2.0 billion in 2010 to an estimated $10.0 billion in 2019. The increase in the number of available therapeutics has led to challenges in therapy selection for physicians and patients.

To address these challenges, we have developed a portfolio of genomic testing products to guide therapy selection across the prostate cancer care continuum and in alignment with NCCN guidelines, which range from localized disease to metastatic disease. Our product portfolio is summarized below.

 

LOGO



 

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Our Competitive Strengths

We believe our competitive strengths enable us to increase adoption of our clinically actionable marketed products and rapidly and efficiently develop new urologic cancer testing products. Our competitive strengths include the following:

 

   

Ability to accelerate commercial traction for our products that will span the prostate cancer care continuum.

 

   

Leading access to practice-changing clinical trials.

 

   

Robust whole transcriptome analysis and proprietary machine learning algorithms.

 

   

Payor coverage and reimbursement.

Our Strategy

Our objective is to be the leading provider of precision oncology genomic tests for urologic cancers. To accomplish this, we plan to:

 

   

Accelerate adoption of our currently marketed products by educating physicians to use our products to make more informed treatment plan decisions. We have experienced rapid growth in our test volume to date and believe there are significant opportunities for additional growth with our currently marketed products. To facilitate this growth, in August 2019, we initiated a sales expansion strategy to expand our sales team from 12 sales representatives to 17 by year-end 2019. By the end of 2020, we grew our sales team to 25 total sales representatives and plan to expand to approximately 34 sales representatives by the end of 2021 to further broaden and support existing physician relationships and increase our efforts directed at urologists, radiation oncologists and medical oncologists.

 

   

Further increase our product offerings. We plan to continue to increase our product offerings, with the goal of our products spanning the entire prostate cancer care continuum by the end of 2023. We have also developed Decipher Bladder, which we plan to introduce in mid-2021 and is anticipated to be one of the first genomic tests for localized bladder cancer. Our current product development pipeline also includes expansion of indications for Decipher testing to castrate-resistant and metastatic prostate cancer, predictive biomarkers for response to ADT, second generation AR signaling inhibitors (ARSi) and docetaxel chemotherapy. We also plan to continue to develop additional products for unmet needs within urologic cancers, including kidney cancer.

 

   

Expand reimbursement coverage for our products. We plan to expand reimbursement coverage for our currently marketed products, specifically with commercial payors. We believe that inclusion of Decipher Prostate for multiple indications in the NCCN and American Society of Clinical Oncology guidelines will facilitate these efforts. Moreover, we received draft Medicare coverage in April 2020 covering muscle invasive and non-muscle invasive bladder cancer and expect to receive a final Medicare coverage decision for Decipher Bladder in mid-2021, which could enable access to a new market of approximately 80,000 patients per year.

 

   

Leverage Decipher GRID to accelerate the development of novel practice changing tests. As our database continues to strengthen with additional patient data from clinical trials and commercial samples, and we simultaneously scale our internal operational capabilities, we believe we will be able to continue to bring innovative products to market.

 

   

Strengthen our relationships with pharmaceutical companies. We are focused on expanding the depth and breadth of our pharmaceutical relationships. Our goal is to capitalize on insights and relationships gained from our early partnerships in order to deepen our existing relationships as well as attract new pharmaceutical partners. Increasing utilization of our products by pharmaceutical



 

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companies not only allows us to generate additional revenue, but also provides us valuable clinical trial data that further enhances the robustness and strategic value of Decipher GRID.

Preliminary Unaudited Financial Update

For the year ended December 31, 2020, overall genomic test volume increased     % to              total genomic test results as compared to the year ended December 31, 2019.

While we have not finalized our full financial results for the year, we expect to report total revenue in the range of approximately $             to $             million and total cost and operating expenses in the range of approximately $             to $             million for the year ended December 31, 2020. We also expect to report total other income (expense), net in the range of approximately $             to $             million for the year ended December 31, 2020. We also had a cash balance of approximately $             as of December 31, 2020. These amounts are preliminary, have not been audited and are subject to change in connection with the completion of our financial statements for the year ended December 31, 2020. In addition, our independent registered public accounting firm does not express an opinion or any other form of assurance with respect thereto. Accordingly, you should not place undue reliance on this information. Additional information and disclosures would be required for a more complete understanding of our financial position and results of operations as of, and for the period ended on, December 31, 2020.

COVID-19 Update

We are closely monitoring the impact of the COVID-19 pandemic on our business and are taking proactive efforts designed to protect the health and safety of our workforce, continue our business operations and advance our corporate objectives. For example, as we continue to actively advance our strategic objectives, in order to comply with applicable regulations and to safeguard the health and safety of our employees and customers, we temporarily reduced our on-site business operations, implemented work-from-home practices, and modified other business practices, including those related to employee travel and physical participation in meetings, events and conferences. In addition, we experienced a reduction in genomic testing volume of 14% in the second quarter of 2020, as compared to the first quarter of 2020, which we believe is linked to delays and/or cancellations in patient visits and thus lower genomic testing volume from ordering physicians in response to COVID-19. While we are unable to predict the pace, timing or occurrence of any rescheduled patient visits, we anticipate that a majority of these delayed and/or canceled patient visits will be subsequently rescheduled as applicable restrictions and guidelines are eased, which we believe is supported by recent metrics available to us. For example, for the third quarter of 2020, total genomic testing volumes increased 8% and 25% as compared to the first quarter and second quarter of 2020, respectively.

The effects of the stay-at-home orders and work-from-home policies have impacted productivity, and may continue to disrupt our business and product development timelines, the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct business in the ordinary course. You should read the section titled “Risk Factors” for more information regarding the potential impact of the COVID-19 pandemic on our business and operations. We will continue to evaluate the impact of the COVID-19 pandemic on our business and expect to continue to reevaluate the timing of our strategic objectives as we learn more and the duration of impact of COVID-19 on our industry becomes clearer.

Summary of Risks Associated with Our Business

Our business is subject to a number of risks of which you should be aware before making a decision to invest in our common stock. These risks are more fully described in the section titled “Risk Factors” immediately following this prospectus summary. These risks include, among others, the following:

 

   

We have incurred net losses in each year since our inception and may incur net losses in the future. We may never achieve or sustain profitability.



 

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We currently derive substantially all of our revenue from sales of Decipher Biopsy and Decipher RP and if we are unable to increase sales of these genomic tests or successfully develop and commercialize new genomic tests, our revenue will be insufficient for us to achieve profitability.

 

   

Our business depends on our ability to obtain and maintain adequate reimbursement from government healthcare programs and other third-party payors.

 

   

We may not be able to maintain or gain increased inclusion of our products in influential clinical guidelines, which could hinder our efforts at gaining market acceptance.

 

   

If our current and future products do not perform as expected, our operating results, reputation and business could be harmed.

 

   

If we cannot compete successfully, we may be unable to increase or sustain our revenue or achieve and sustain profitability.

 

   

If our sole laboratory facility becomes damaged or inoperable, or we are required to vacate the facility, or are unable to increase our capacity, our ability to perform our genomic testing and pursue our research and development efforts may be jeopardized.

 

   

Our business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic, which has adversely impacted and could continue to adversely impact our business, including the demand for our tests, as well as the business or operations of physicians and other healthcare providers who order our tests and third-party payors responsible for reimbursement for our tests, customers and other third parties with whom we conduct business.

 

   

If we lose the support of key opinion leaders, or KOLs, it may be difficult to establish our products as a standard of care for patients with urologic cancer, which may limit our revenue growth and ability to achieve profitability.

 

   

If we fail to maintain our current clinical or scientific partnerships and collaborations or enter into new partnerships and collaborations, our development and commercialization of additional products could be materially adversely affected.

 

   

Our failure to continue to attract, hire and retain a sufficient number of qualified sales professionals would hamper our ability to increase demand for our genomic tests, to expand geographically and to successfully commercialize any other tests or products we may develop.

 

   

If we are unable to obtain and maintain sufficient patent rights for our products or services, we may not be able to compete effectively in our markets.

Corporate and Other Information

We were incorporated in the province of British Columbia on December 16, 2008 under the British Columbia Business Corporations Act under the name GenomeDx Biosciences Inc. On December 19, 2008, GenomeDx Biosciences Inc. acquired all of the shares of Genome Diagnostics Inc., a Delaware corporation, pursuant to a transaction in which the former stockholders of Genome Diagnostics Inc. became the stockholders of GenomeDx Biosciences Inc. On July 11, 2018, GenomeDx Biosciences Inc. was reincorporated as a Delaware corporation and subsequently changed its name to Decipher Biosciences, Inc. on January 25, 2019. We have one wholly owned subsidiary, which was incorporated in the state of Delaware on January 17, 2012 under the name GenomeDx Biosciences Corp. and subsequently changed its name to Decipher Corp. on April 30, 2019. Our principal executive office is located at 6925 Lusk Boulevard, Suite 200, San Diego, California 92121, and our telephone number is (888) 975-4540. Our website address is decipherbio.com. The information contained on, or that can be accessed through, our website is not part of this prospectus. Investors should not rely on any such information in deciding whether to purchase our common stock.

The Decipher Biosciences logo, “Decipher,” “Decipher RP,” “Decipher Post-Op,” “Decipher Biopsy,” “Decipher Bladder,” “Decipher GRID,” “GRID” and other trademarks, trade names or service marks of Decipher



 

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Biosciences appearing in this prospectus are the property of Decipher Biosciences as is the Decipher Biosciences corporate name. All other service marks, trademarks and trade names appearing in this prospectus are the property of their respective owners. Solely for convenience, trademarks and trade names referred to in this prospectus appear without the ® TM symbols, but those references are not intended to indicate that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and trade names.

Throughout this prospectus, when we refer to “Decipher Biopsy” we are referring to our Decipher Prostate Biopsy genomic test, when we refer to “Decipher RP” we are referring to our Decipher Prostate RP genomic test and when we refer to “Decipher Prostate” we are referring to both Decipher Biopsy and Decipher RP. In addition, unless otherwise indicated, when we refer to shares of Series A, B, C, D or D Prime preferred stock, we are also referring to the shares of Class A, B, C, D or D Prime preferred shares of our predecessor entity, GenomeDx Biosciences Inc., as applicable, prior to our reincorporation into a Delaware corporation.

Implications of Being an Emerging Growth Company and a Smaller Reporting Company

As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An “emerging growth company” may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

 

   

being permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations in this prospectus;

 

   

not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, as amended, or the Sarbanes-Oxley Act;

 

   

reduced disclosure obligations regarding executive compensation in our periodic reports, proxy statements and registration statements; and

 

   

exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and any golden parachute payments not previously approved.

We may use these provisions until, at latest, the last day of our fiscal year following the fifth anniversary of the completion of this offering. If certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange Act, our annual gross revenue exceed $1.07 billion, or we issue more than $1.0 billion of non-convertible debt in any three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

We have elected to take advantage of certain of the reduced disclosure obligations in the registration statement of which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. Moreover, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have elected to avail ourselves of this exemption and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, the information that we provide to our stockholders may be different than the information you might receive from other public reporting companies in which you hold equity interests.

We are also a “smaller reporting company” as defined in Regulation S-K under the Securities Act of 1933, as amended, or the Securities Act, and have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies. We may be a smaller reporting company even after we are no longer an emerging growth company.



 

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The Offering

 

Common stock offered by us

                     shares.

 

Underwriters’ option to purchase additional shares

The underwriters have an option, exercisable within 30 days of the date of this prospectus, to purchase up to                  additional shares of our common stock.

 

Common stock to be outstanding immediately after this offering

                 shares (or                 shares if the underwriters exercise their option to purchase additional shares in full).

 

Use of proceeds

We intend to use the net proceeds from this offering to repay a portion of the aggregate principal amount outstanding under our loan agreement, and to pay accrued interest on such outstanding principal amount as well as a loan prepayment fee and back-end fee, and the remainder for working capital and other general corporate purposes, including commercial expansion and clinical trial costs. See the section titled “Use of Proceeds” for additional information.

 

Risk factors

You should read the section titled “Risk Factors” and other information included in this prospectus for a discussion of factors you should consider carefully before deciding to invest in our common stock.

 

Proposed Nasdaq Global Market symbol

“DECI”

The number of shares of our common stock to be outstanding after this offering is based on 42,445,480 shares of common stock outstanding as of September 30, 2020, after giving effect to the conversion of all of our outstanding shares of redeemable convertible preferred stock into an aggregate of 40,197,095 shares of common stock in connection with the closing of this offering, and excludes:

 

   

5,868,623 shares of our common stock issuable upon the exercise of outstanding stock options as of September 30, 2020, with a weighted-average exercise price of $0.83 per share;

 

   

1,444,982 shares of our common stock issuable upon the exercise of outstanding stock options granted after September 30, 2020, with a weighted-average exercise price of $3.83 per share;

 

   

4,375 shares of our common stock issuable upon the exercise of a warrant outstanding as of September 30, 2020, with an exercise price of $13.71 per share;

 

   

167,500 shares of our common stock issuable upon the exercise of a warrant outstanding as of September 30, 2020, with an exercise price of $11.40 per share, which warrant will terminate pursuant to its terms upon the closing of this offering unless previously exercised;

 

   

                 shares of our common stock reserved for future issuance under our 2021 Equity Incentive Plan, or the 2021 Plan, including                shares of common stock reserved for issuance under our 2018 Equity Incentive Plan, as amended, or the 2018 Plan, which shares will be added to the 2021 Plan upon its effectiveness, as well as any annual automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective upon the execution and delivery of the underwriting agreement for this offering; and

 

   

                shares of our common stock reserved for future issuance under our 2021 Employee Stock Purchase Plan, or ESPP, as well as any annual automatic increases in the number of shares of our



 

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common stock reserved for future issuance under the ESPP, which will become effective upon the execution and delivery of the underwriting agreement for this offering.

Unless otherwise indicated, all information contained in this prospectus assumes or gives effect to:

 

   

the conversion of all of our outstanding shares of redeemable convertible preferred stock as of September 30, 2020 into an aggregate of 40,197,095 shares of common stock in connection with the closing of this offering;

 

   

no exercise of the outstanding options or warrants described above;

 

   

no exercise by the underwriters of their option to purchase up to a total of                  additional shares of our common stock;

 

   

the filing and effectiveness of our amended and restated certificate of incorporation and the adoption of our amended and restated bylaws immediately prior to and upon the completion of this offering, respectively; and

 

   

a 1-for-    reverse stock split of our common stock effected on                , 2021.



 

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Summary Consolidated Financial and Other Data

The following tables set forth a summary of our consolidated financial and other data as of, and for the periods ended on, the dates indicated. We have derived the summary consolidated statements of operations data for the years ended December 31, 2018 and 2019 and the summary consolidated balance sheet data as of December 31, 2019 from our audited consolidated financial statements included elsewhere in this prospectus. We have derived the summary consolidated statements of operations data for the nine months ended September 30, 2019 and 2020 and the summary consolidated balance sheet data as of September 30, 2020 from our unaudited condensed consolidated financial statements included elsewhere in this prospectus. The summary consolidated financial data included in this section are not intended to replace the consolidated financial statements and related notes included elsewhere in this prospectus. You should read the following summary consolidated financial data together with the sections titled “Selected Consolidated Financial and Other Data” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results to be expected for any other period in the future.

 

    Year Ended December 31,     Nine Months Ended
September 30,
 
            2018                     2019             2019     2020  
                (unaudited)  
    (in thousands, except share, per share and other data)  

Consolidated Statements of Operations Data:

       

Revenue:

       

Genomic testing

  $ 10,660     $ 15,968     $ 10,131     $ 27,382  

Other

    1,411       556       544       30  
 

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

    12,071       16,524       10,675       27,412  
 

 

 

   

 

 

   

 

 

   

 

 

 

Cost and operating expenses:

       

Cost of revenue(1)

    10,886       9,367       6,715       8,539  

Research and development(1)

    2,961       3,599       2,849       2,954  

Sales and marketing(1)

    10,906       10,203       7,141       9,304  

General and administrative(1)

    7,574       6,641       4,733       5,316  

Legal settlement

    2,551       —         —       —  
 

 

 

   

 

 

   

 

 

   

 

 

 

Total cost and operating expenses

    34,878       29,810       21,438       26,113  
 

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

    (22,807     (13,286     (10,763     1,299  

Other income (expense), net:

       

Interest income

    8       54       35       12  

Interest expense on long-term debt – related party

    (4,233     (4,632     (3,395     (4,709

Interest expense and settlement of convertible promissory notes

    (3,768     (1,561     (1,561     —    

Revaluation of warrants and embedded derivative liabilities

    843       721       721       —    

Other income (expense), net

    45       247       200       1  
 

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

    (7,105     (5,171     (4,000     (4,696
 

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

    (29,912     (18,457     (14,763     (3,397

Tax expense (benefit)

    25       (6     —         (33
 

 

 

   

 

 

   

 

 

   

 

 

 

Net loss and comprehensive loss

    (29,937     (18,451     (14,763     (3,364

Accretion to redemption value of redeemable convertible preferred stock

    (4,982     (395     (395     (1,137

Accruing dividends on redeemable convertible preferred stock with carrying value in excess of redemption value

    (731     (2,063     (1,420     (778

Deemed dividend on redeemable convertible preferred stock issuances

    —         (2,026     (2,026     —    

Gain on extinguishment of redeemable convertible preferred stock

    16,700       103,523       103,523       —    

Net income allocable to preferred stockholders

    —         (75,284     (79,063     —    
 

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to common stockholders

  $ (18,950   $ 5,304     $ 5,856     $ (5,279
 

 

 

   

 

 

   

 

 

   

 

 

 


 

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    Year Ended December 31,     Nine Months Ended
September 30,
 
            2018                     2019             2019     2020  
                (unaudited)  
    (in thousands, except share, per share and other data)  

Net income (loss) per share attributable to common stockholders(2):

       

Basic

  $ (10.64   $ 2.48     $ 2.77     $ (2.35
 

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

  $ (10.64   $ (0.57   $ (0.48   $ (2.35
 

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares of common stock outstanding(2):

       

Basic

    1,780,497       2,138,072       2,110,473       2,244,284  
 

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

    1,780,497       32,483,381       30,603,564       2,244,284  
 

 

 

   

 

 

   

 

 

   

 

 

 

Pro forma net loss attributable to common stockholders – basic and diluted (unaudited)(3)

    $ (19,214     $ (3,364
   

 

 

     

 

 

 

Pro forma net loss per share attributable to common stockholders – basic and diluted (unaudited)(3)

    $ (0.51     $ (0.08
   

 

 

     

 

 

 

Pro forma weighted-average shares of common stock outstanding – basic and diluted (unaudited)(3)

      37,979,639         42,441,379  
   

 

 

     

 

 

 

Other Data:

       

Genomic testing volume(4)

    10,655       11,538       8,123       11,812  
 

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Includes stock-based compensation expense as follows:

 

     Year Ended December 31,      Nine Months Ended
September 30,
 
           2018                  2019                2019              2020      
                   (unaudited)  
     (in thousands)  

Cost of revenue

   $ 8      $ 44      $ 25      $ 57  

Research and development

     109        273        211        189  

Sales and marketing

     80        185        100        248  

General and administrative

     248        432        270        681  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 445      $ 934      $ 606      $ 1,175  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

(2)

See Note 1 to each of our audited consolidated financial statements and our unaudited condensed consolidated financial statements included elsewhere in this prospectus for a description of how we compute historical basic and diluted net loss per share and the weighted-average number of shares used in the computation of these per share amounts.

(3)

Our pro forma net loss per share attributable to common stockholders – basic and diluted assumes all shares of our redeemable convertible preferred stock outstanding at the end of each period had converted into common stock at the beginning of each respective period. As a result of the assumed conversion of our redeemable convertible preferred stock at the beginning of each period, the pro forma net loss attributable to common stockholders – basic and diluted equals the net loss for the nine months ended September 30, 2020 and equals the net loss for the year ended December 31, 2019, less $0.8 million related to the change in fair value of the preferred stock warrants liability.

(4)

Genomic testing volume represents the total number of genomic test results delivered to ordering physicians and pharmaceutical partners.



 

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     As of September 30, 2020  
     Actual     Pro
Forma(1)
    Pro Forma
As Adjusted(2)
 
     (unaudited, in thousands)  

Consolidated Balance Sheet Data:

  

Cash and cash equivalents

   $ 14,547     $ 14,547     $                    

Total assets

     29,690       29,690    

Working capital (deficit)(3)

     (27,175     (27,175  

Long-term debt, related party, net of debt discount

     40,359       40,359    

Redeemable convertible preferred stock

     40,282       —      

Accumulated deficit

     (65,202     (65,202  

Total stockholders’ equity (deficit)

     (62,088     (21,806  

 

(1)

The pro forma consolidated balance sheet data gives effect to (i) the conversion of all outstanding shares of our redeemable convertible preferred stock as of September 30, 2020 into an aggregate of 40,197,095 shares of common stock, and the resultant reclassification of the carrying value of our redeemable convertible preferred stock to permanent equity, in connection with the closing of this offering, and (ii) the filing and effectiveness of our amended and restated certificate of incorporation immediately prior to the completion of this offering.

(2)

The pro forma as adjusted consolidated balance sheet data gives effect to (i) the pro forma adjustments set forth in footnote (1) above, (ii) the issuance and sale of                shares of our common stock in this offering at the assumed initial public offering price of $                per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and (iii) $                million of the net proceeds from this offering used to repay a portion of the aggregate principal amount outstanding under our loan agreement, and to pay accrued interest on such outstanding principal amount as well as related back-end, loan prepayment fees and the resultant charges, including the write-off of the proportionate unamortized debt issuance costs (for additional details, see the section titled “Use of Proceeds”). Each $1.00 increase (decrease) in the assumed initial public offering price of $                per share would increase (decrease) the pro forma as adjusted amount of each of our cash and cash equivalents, working capital, total assets and total stockholders’ equity (deficit) by approximately $                , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1.0 million shares in the number of shares we are offering at the assumed initial public offering price of $                share would increase (decrease) the pro forma as adjusted amounts of each of our cash and cash equivalents, working capital, total assets and total stockholders’ equity (deficit) by approximately $                million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing.

(3)

Working capital is calculated as current assets less current liabilities. See our consolidated financial statements and related notes included elsewhere in this prospectus for further details regarding our current assets and current liabilities.



 

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RISK FACTORS

Investing in our common stock involves a high degree of risk. You should carefully consider the risks described below, as well as the other information in this prospectus, including our consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” before deciding whether to invest in our common stock. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and growth prospects. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

Risks Relating to Our Business and Strategy

We have incurred net losses in each year since our inception and may incur net losses in the future. We may never achieve or sustain profitability.

We have incurred net losses since our inception, including consolidated net losses of $29.9 million and $18.5 million for the years ended December 31, 2018 and 2019, respectively, and $3.4 million for the nine months ended September 30, 2020, and we have never been profitable on an annual basis. As of September 30, 2020, our accumulated deficit was $65.2 million. Our prior losses, combined with expected future losses, have had and may continue to have an adverse effect on our stockholders’ equity (deficit) and working capital.

In recent years, we have incurred significant costs in connection with product development and commercialization activities. For the years ended December 31, 2018 and 2019, our research and development expenses were $3.0 million and $3.6 million, respectively, our sales and marketing expenses were $10.9 million and $10.2 million, respectively, and our general and administrative expenses were $7.6 million and $6.6 million, respectively. For the nine months ended September 30, 2019 and 2020, our research and development expenses were $2.8 million and $3.0 million, respectively, our sales and marketing expenses were $7.1 million and $9.3 million, respectively, and our general and administrative expenses were $4.7 million and $5.3 million, respectively. We expect our expenses and losses to continue to increase in the future due to the increased costs we incur as we conduct additional research and development activities, expand our staff to sell and support our products, seek to drive commercial adoption of and reimbursement for our current products and any new products we develop, and incur costs associated with being a public company. As a result, we need to generate significant revenue in order to achieve and sustain profitability. Our ability to achieve or sustain profitability is based on numerous factors, many of which are beyond our control, including the market acceptance of our products, reimbursement, the regulatory environment, our competitive position, future product development, our market penetration and the degree to which we are able to obtain and maintain intellectual property protection for our products. We may never be able to generate sufficient revenue to achieve or sustain profitability.

We are an early, commercial-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance.

We are an early commercial-stage company and have a limited operating history. While we received an LCD for our first commercial product, Decipher RP, in 2015, we only recently launched some indications of our Decipher Biopsy products as recently as November 2020. Our limited operating history may make it difficult to evaluate our current business and this makes predictions about our future success or viability subject to significant uncertainty. We will continue to encounter risks and difficulties frequently experienced by early commercial-stage companies, including those associated with launching new products, increasing the size of our organization, including our sales force, seeking to drive commercial adoption and reimbursement of our products and developing new products. If we do not address these risks successfully, our business could suffer.

 

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We currently derive substantially all of our revenue from sales of Decipher Biopsy and Decipher RP and if we are unable to increase sales of these genomic tests or successfully develop and commercialize new genomic tests, our revenue will be insufficient for us to achieve profitability.

We currently derive substantially all of our revenue from sales of our prostate cancer genomic testing products, Decipher Biopsy and Decipher RP. If we are unable to expand the adoption and increase sales of Decipher Biopsy and Decipher RP and obtain and maintain adequate reimbursement for our products, or successfully develop and commercialize new genomic tests, our revenue and our ability to achieve profitability will be impaired.

Decipher Biopsy and Decipher RP and any other genomic tests that we develop may never achieve significant market acceptance with physicians.

We may not succeed in achieving significant commercial market acceptance of our genomic tests with physicians. Our ability to successfully commercialize Decipher Biopsy and Decipher RP and any future genomic tests that we develop with physicians will depend on several factors, including:

 

   

the extent to which payors adequately reimburse our genomic tests, which will affect patients’ willingness or ability to pay for our tests and will likely heavily influence physicians’ decisions to recommend our genomic tests;

 

   

the inclusion of our products in influential clinical practice guidelines;

 

   

the willingness of physicians to utilize our genomic tests;

 

   

our ability to educate the medical community and third-party payors on the clinical utility and value of our genomic tests and their potential advantages over other diagnostic and prognostic tools;

 

   

the effectiveness of our sales force; and

 

   

conducting additional studies of our genomic tests to demonstrate their clinical utility and value in important medical decisions such as treatment selection.

These factors present obstacles to commercial acceptance of our genomic tests by physicians, and will require substantial time and money to overcome, if we can do so at all. Our inability to successfully do so would harm our business.

Physicians are the primary persons who order genomic tests for patients. We may experience reluctance, or refusal, on the part of physicians to order, and third-party payors to cover and provide adequate reimbursement for, our genomic tests if the results of our research and clinical studies, and our sales and marketing activities relating to communication of these results, do not convey to physicians, payors and patients that our genomic tests provide equivalent or better diagnostic or prognostic information than other available technologies and methodologies.

To generate demand for our current genomic tests and our planned genomic tests, we will need to educate urologists, oncologists, pathologists, and other healthcare professionals on the clinical utility, benefits and value of the tests we provide through published papers, presentations at scientific conferences, educational programs and one-on-one education sessions by members of our sales force. In addition, we need to assure physicians who are treating prostate cancer of our ability to obtain and maintain adequate reimbursement coverage from payors. We may need to hire additional commercial, scientific, technical and other personnel to support this process. In addition, gaining acceptance in medical communities, including KOLs, requires, among other things, publication in leading peer-reviewed journals of results from studies using our genomic tests. The process of publication in leading medical journals is subject to a peer review process and peer reviewers may not consider the results of our studies sufficiently novel or worthy of publication. Failure to have our studies published in peer-reviewed journals would limit the adoption of our current and planned genomic tests. If we cannot convince medical practitioners to order our current or future genomic tests, we will likely be unable to create demand in sufficient volume for us to achieve sustained profitability.

 

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Failure to achieve widespread market acceptance of our current tests and any future genomic tests that we develop with physicians would materially harm our business, financial condition and results of operations.

Our quarterly and annual operating results and cash flows may fluctuate in the future, which could cause the market price of our stock to decline substantially.

Numerous factors, many of which are outside our control, may cause or contribute to significant fluctuations in our quarterly and annual operating results. These fluctuations may make financial planning and forecasting uncertain and may result in unanticipated decreases in our available cash, which could negatively affect our business and prospects. For example, the majority of our testing volume is dependent on patient visits to physicians’ offices. Volume of testing generally declines during the summer months of July and August, the year-end holiday periods and other major holidays. In addition, volume of testing tends to decline due to adverse weather conditions, such as excessively hot or cold spells or hurricanes or tornados in certain regions, consequently reducing revenue and cash flows in any affected period. Further, we experience quarter-to-quarter volatility in our pharmaceutical revenue due to the timing and size of sample shipments from pharmaceutical partners which vary depending on the retrospective versus prospective nature of the underlying sample cohorts. In addition, one or more of such factors may cause our revenue or operating expenses in one period to be disproportionately higher or lower relative to the others. For these and other reasons, comparing our operating results on a period-to-period basis may be difficult to understand and may not be meaningful. You should not rely on our past results as indicative of our future performance.

In addition, a significant portion of our operating expense is relatively fixed in nature, and planned expenditures are based in part on expectations regarding future revenue. Accordingly, unexpected revenue shortfalls could decrease our gross margins and cause significant changes in our operating results from quarter to quarter. If this occurs, the trading price of our common stock could fall substantially.

This variability and unpredictability caused by factors such as those described above could also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or below any guidance we may provide, or if the guidance we provide is below the expectations of analysts or investors, the trading price of our common stock could decline substantially. Such a stock price decline could occur even when we have met any previously publicly stated guidance we may provide.

We may not be able to maintain or gain increased inclusion of our products in influential clinical guidelines, which could hinder our efforts at gaining market acceptance.

Clinical guidelines such as those promulgated by the NCCN are highly influential with physicians and payors, and generally can serve to accelerate market acceptance and reimbursement for products and services that are endorsed by these guidelines. However, we believe clinical guidelines typically adopt a conservative approach to the practice of medicine, which we believe can delay changes in historical clinical practices and the adoption of alternative products. Although Decipher Biopsy and Decipher RP have been integrated into the NCCN guidelines, if we are unsuccessful in maintaining and increasing the level of recommendation of our genomic tests within these guidelines, are unable to cause any new genomic tests we develop to be included in these guidelines, or are unable to cause our genomic tests to be included in other influential guidelines, we may be at a disadvantage in gaining market acceptance and market share relative to our competitors. Gaining broader inclusion for our products in influential guidelines is an important element of our business strategy and if we are unsuccessful in these efforts, our business, financial condition and results of operations could be harmed.

Any failure in clinical trials involving our genomic tests could have a material adverse impact on the market opportunity for our genomic tests.

As part of our business strategy, we are partnering with investigators and pharmaceutical companies for the use of our tests in clinical trials. For example, we will be participating in the National Cancer Institute-sponsored

 

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clinical trial of NUBEQA, an FDA-approved treatment of nmCRPC, called ERADICATE. The clinical trial will assess if the drug is useful for high-risk localized prostate cancer patients identified by Decipher RP. If this clinical trial is successful, we believe that Decipher RP could be broadly integrated into the standard of care in localized prostate cancer for predicting and accelerating early use of NUBEQA for approximately 65,000 patients per year. However, the clinical trial may not be successful, and any failure in the clinical trial or other clinical trials involving our genomic tests could have a material adverse impact on the market opportunity for our genomic tests.

If we cannot develop genomic solutions to keep pace with rapid advances in technology, medicine and science, our operating results and competitive position could be harmed.

Our current technological approach relies on whole transcriptome analysis. In recent years, there have been numerous advances in technologies relating to the diagnosis and treatment of cancer. New diagnostic tests and therapeutics are continuously being developed, including DNA-based and other technological approaches. We must continuously develop new genomic tests and enhance our existing genomic tests to keep pace with evolving technological advancements and standards of care. Our inability to do so would materially harm our business, financial condition and results of operations.

New product development involves a lengthy and complex process and we may be unable to develop and commercialize, or receive reimbursement for new products on a timely basis, or at all.

We continually seek to develop new product offerings, which requires us to devote considerable resources to research and development. Our product development process takes time and involves a high degree of risk, and such development efforts may fail for many reasons, including failure of the product to perform as expected, failure to successfully complete analytic and clinical validation, or failure to demonstrate the clinical utility of the product.

As we develop new products, we will have to make significant investments in research and development, marketing, selling, coverage and reimbursement activities. Typically, few research and development projects result in a commercialized product, and we may not be able to successfully develop new products that can be commercialized. At any point, we may abandon development of a product or we may be required to expend considerable resources conducting research, which would adversely affect the timing for generating potential revenue from a new product and our ability to invest in other products in our pipeline. If a clinical validation study fails to demonstrate the prospectively defined endpoints of the study or if we fail to sufficiently demonstrate analytical validity or clinical utility, we might choose to abandon the development of the product, which could harm our business. In addition, competitors may develop and commercialize competing products or technologies faster than us or at a lower cost.

If our current and future products do not perform as expected, our operating results, reputation and business could be harmed.

Our success depends on customer confidence that our products can provide reliable, high-quality genomic analysis and results. We believe that our customers are likely to be particularly sensitive to test defects and errors. As a result, the failure of our products to perform as expected could significantly impair our reputation and the public image of our products, and we may be subject to legal claims arising from any defects or errors.

If our sole laboratory facility becomes damaged or inoperable, or we are required to vacate the facility, or are unable to increase our capacity, our ability to perform our genomic testing and pursue our research and development efforts may be jeopardized.

We perform all of our testing in our laboratory facility located in San Diego, California. We do not have redundant laboratory facilities. Our laboratory facilities could become inoperable, including due to circumstances

 

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beyond our control, which could adversely affect our business and operations. Our facilities, the equipment we use to perform our tests and services and our other business process systems would be costly to replace and could require substantial time to repair or replace.

Our facilities may be damaged or destroyed by natural or man-made disasters, including earthquakes, wildfires, floods, acts of terrorism or other criminal activities, infectious disease outbreaks and power outages, which may render it difficult or impossible for us to perform our genomic tests for some period of time. In particular, San Diego is situated on or near earthquake fault lines and, in recent years, has experienced serious fires, flooding and power outages. Any of these disasters, including the COVID-19 pandemic, may temporarily interrupt our ability to receive specimens or materials from our suppliers and to have access to our various systems necessary to operate our business. The inability to perform our genomic tests could result in the loss of customers and harm our reputation, and we may be unable to regain those customers in the future. We carry insurance for damage to our property and the disruption of our business, but this insurance may not be sufficient to cover all of our potential losses and may not continue to be available to us on acceptable terms, or at all.

In addition, as a result of the COVID-19 pandemic, we may also experience supply, logistics or other disruptions. The pandemic has and may continue to cause test volumes to decrease due to prioritization of hospital or clinical resources toward the pandemic or government-imposed stay-at-home orders that impede patient movement or interrupt healthcare services.

Our facilities may also be rendered inoperable as a result of regulatory sanction. We are subject to federal and state laws and regulations regarding the operation of clinical laboratories. Clinical Laboratory Improvement Amendments, or CLIA, and laws of California and certain other states impose certification requirements for clinical laboratories, and establish standards for quality assurance and quality control, among other things.

Clinical laboratories are subject to inspection by regulators, and to sanctions for failing to comply with applicable requirements. Sanctions available under CLIA include prohibiting a laboratory from running tests, requiring a laboratory to implement a corrective plan, and imposing civil monetary penalties. If we fail to meet any applicable requirements of CLIA or state law, that failure could adversely affect any future consideration by the U.S. Centers for Medicare & Medicaid Services, or CMS, of our technologies, prevent their approval entirely, and/or interrupt the commercial sale of any products and otherwise cause us to incur significant expense.

In the event our facility is rendered inoperable, we may need to engage a third-party to perform laboratory testing services on our behalf. In order to rely on a third-party to perform these testing services, we could only use another facility with established state licensure and CLIA accreditation. We may not be able to find another CLIA-certified facility able or willing to perform the necessary tests for us on commercially reasonable terms, or at all. Finding a new laboratory that meets the required state licensure and CLIA accreditation standards or developing new systems necessary to operate our business would be time-consuming and costly and could result in delays in our ability to provide genomic testing services or to provide the same level of quality in genomic testing services as we currently provide, which could harm our reputation and adversely affect our business, results of operations and financial condition. In addition, requirements of payors and regulatory limitations on marking-up of laboratory testing could substantially limit our ability to profit from testing that we do not ourselves perform.

In addition, as we grow our business, our laboratory facilities and equipment may become inadequate to support our expanded genomic testing operations. In such event, we may need to implement automation or procure additional laboratory facility space and associated necessary state licensure and CLIA accreditations. For example, we have initiated the process of automating portions of assay workflow, the results of which are expected to increase annual processing capacity by 10,000 samples by the end of 2021. Any such automation may not yield the anticipated benefits and may encounter difficulties or result in increased costs. In addition, we may not be able to procure any such laboratory facilities, licenses or accreditations when required or on acceptable terms. Any such failures would limit our ability to grow.

 

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Our business is subject to risks arising from epidemic diseases, such as the COVID-19 pandemic, which has adversely impacted and could continue to adversely impact our business, including the demand for our tests, as well as the business or operations of physicians and other healthcare providers who order our tests and third-party payors responsible for reimbursement for our tests, customers and other third parties with whom we conduct business.

Public health crises such as pandemics or similar outbreaks have adversely impacted and could continue to adversely impact our business. In particular, the COVID-19 pandemic and the measures imposed to contain this pandemic have disrupted and are expected to continue to impact our business. Global efforts to contain the spread of COVID-19 have intensified, with the federal government and many state and local governments implementing severe travel restrictions, social distancing requirements and stay-at-home orders, among other restrictions. In addition, while certain geographical areas have begun gradual movement towards the easing of these COVID-19 related restrictions, reports of increased infection are leading to additional public health directives and orders that may have an unpredictable impact on our financial condition, results of operations, liquidity and cash flows.

For example, as a result of the COVID-19 pandemic, or similar pandemics, and federal, state and local government responses to such pandemics, we have and/or may in the future experience disruptions that could adversely impact our business, including, but not limited to:

 

   

decreased tests volume due to a decline in orders as patient visits for routine examinations, biopsy procedures and radical prostatectomy surgeries are being delayed and/or canceled;

 

   

disruption of our sales and commercialization activities due to limitations on our ability to communicate with physicians as a result of travel restrictions, office closures or other hindered means of communicating with physicians;

 

   

delays or disruptions by third parties in the collection, preparation or delivery of the samples that we test;

 

   

delays or difficulties in delivering test reports, interruptions in research and development and other limitations of key business activities due to members of our workforce becoming ill and/or stay-at-home or other similar orders imposed by or that may be imposed by federal, state and local governments, including at our San Diego, California headquarters;

 

   

delayed reimbursement from Medicare and other third party payors, disruption in our supply channel and other adverse impacts on our business resulting from the negative effects of the COVID-19 pandemic on our suppliers, service providers and other third parties on whom we rely; and

 

   

delayed or postponed interactions with regulators and other important agencies and contractors, due to limitations in employee resources, travel restrictions or forced furlough of government employees.

We experienced declines in total genomic test volume primarily during second quarter of 2020, and we believe this decline was linked to delays and/or cancellations in patient visits in response to COVID-19, resulting in reduced numbers of ordering physicians. For the second quarter of 2020, genomic test volume for our Decipher Biopsy and RP products, decreased 14% as compared to the first quarter of 2020, which we believe was primarily attributable to the effects of the COVID-19 pandemic. For the third quarter of 2020, genomic test volume for our Decipher Biopsy and RP products increased 8% as compared to the second quarter of 2020, as many of our customers began to resume procedures as COVID-19 cases decreased.

Our future results will be dependent upon the extent and duration of the COVID-19 crisis as well as the impact of ongoing federal, state and local government restrictions, which are beyond our control, and which may be eased and/or reinstated from time to time depending on the circumstances, potentially impacting the flow of future patient visits and physician ordering volume. Even with the easing of federal, state and local restrictions, patient visits may be impacted by continued apprehension regarding possible exposure to the virus. As conditions

 

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are continuously evolving, we are unable to predict how our future test volume will be impacted or the extent to which our results of operations, financial condition or cash flows will be impacted by the COVID-19 pandemic, or other future public health crises.

In addition, we are subject to various affirmative and negative covenants in our Loan Agreement (as defined below). If the effects of COVID-19 cause us to fall out of compliance with one or more of such covenants and we are unable to secure a waiver or negotiate an amendment to the Loan Agreement on reasonable terms, or at all, an event of default could occur, which would allow our lender to accelerate our repayment obligations or enforce its other rights under the Loan Agreement. Any such default may also require us to seek additional or alternative financing, which may not be available on commercially reasonable terms or at all. If we are unable to access funds to repay our lender, our lender could take control of our pledged assets. Any of the foregoing events would adversely impact our business, financial condition and liquidity. For more information on risks associated with the Loan Agreement, see below under “—Risks Relating to Our Financial Condition and Capital Requirements—Payments under our loan agreement will reduce our cash and cash equivalents available to fund our operations. In addition, a default under our loan agreement could cause a material adverse effect on our financial position.”

The COVID-19 crisis continues to rapidly evolve. We do not yet know the full extent of potential delays or impacts on our business or the global economy as a whole, and such impacts may not be fully recoverable. The extent to which COVID-19 will impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the crisis, resurgences of the virus, the availability and effectiveness of potential vaccinations or therapeutic treatments, the use of telemedicine, travel restrictions, stay-at-home or other similar orders and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the virus. Any of these factors, individually or in combination, could materially and adversely affect our business, results of operations, financial condition or cash flows. In addition, the current and potential adverse impacts of the COVID-19 pandemic on our business, financial condition, results of operations and growth prospects, may also have the effect of heightening many of the other risks and uncertainties described elsewhere in this “Risk Factors” section.

If we lose the support of KOLs, it may be difficult to establish our products as a standard of care for patients with urologic cancer, which may limit our revenue growth and ability to achieve profitability.

We have established relationships with academic investigators at premier cancer institutions. If these KOLs determine that our current genomic tests, including Decipher Biopsy and Decipher RP, or other genomic tests that we develop are not effective or that alternative technologies are more effective, we would encounter significant difficulty validating our current and future genomic tests, increasing adoption, or commercializing our current or future genomic tests, which would limit our revenue growth and our ability to achieve profitability.

Decipher Biopsy and Decipher RP and any other genomic tests that we develop may never achieve significant market acceptance with pharmaceutical companies.

We may not succeed in achieving significant commercial market acceptance of our genomic test offerings with pharmaceutical companies. Our ability to successfully commercialize Decipher Biopsy and Decipher RP and any future genomic tests that we develop with these customers will depend on several factors, including:

 

   

the costs of our tests and the budgets of the pharmaceutical companies;

 

   

the willingness of pharmaceutical companies to utilize our genomic tests;

 

   

our ability to educate pharmaceutical companies on the clinical utility and the value of our genomic tests and their potential advantages over other diagnostic and prognostic tools; and

 

   

the effectiveness of our pharmaceutical business development team.

 

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These factors present obstacles to commercial acceptance of our genomic tests by pharmaceutical companies, and will require substantial time and money to overcome, if we can do so at all. Our inability to successfully do so would harm our business.

We may experience reluctance, or refusal, on the part of pharmaceutical companies to order our genomic tests if the results of our research and clinical studies, and our sales and marketing activities relating to communication of these results, do not convey to the pharmaceutical companies that our genomic tests provide equivalent or better diagnostic or prognostic information than other available technologies and methodologies.

To generate demand for our current genomic tests and our planned genomic tests, we will need to educate pharmaceutical companies on the clinical utility, benefits and value of the tests we provide through published papers, presentations at scientific conferences, educational programs and one-on-one education sessions by members of our pharmaceutical business development team. We may need to hire additional commercial, scientific, technical and other personnel to support this process. In addition, gaining acceptance requires, among other things, publication in leading peer-reviewed journals of results from studies using our genomic tests. The process of publication in leading medical journals is subject to a peer review process and peer reviewers may not consider the results of our studies sufficiently novel or worthy of publication. Failure to have our studies published in peer-reviewed journals would limit the adoption of our current and planned genomic tests.

Failure to achieve widespread market acceptance of our current tests and any future genomic tests that we develop with pharmaceutical companies would impair our ability to grow our pharmaceutical revenue.

If we fail to maintain our current clinical or scientific partnerships and collaborations or enter into new partnerships and collaborations, our development and commercialization of additional products could be materially adversely affected.

Our ability to develop and validate new products, improve our existing products and win market acceptance for our products, depends in part on the success of our existing partnerships and collaborations, and on our ability to enter into new clinical and scientific partnerships and collaborations. We are currently supporting pharmaceutical companies in clinical trials, including SPARTAN, a pivotal clinical trial of ERLEADA, which has been approved by the FDA and is marketed by Janssen for the treatment of nmCRPC, as well as clinical trials being conducted by Astellas and Dendreon in localized prostate cancer, and our tests are being used in the NCI-sponsored ERADICATE trial. We expect to continue to rely on clinical and scientific partnerships and collaborations with major universities and research institutions as well as pharmaceutical companies for access to data from tissue samples, new research findings, product development efforts and cooperation in clinical trials. However, we may not realize the intended benefits that we believe would come from partnering with pharmaceutical companies and academic institutions on the types of research projects that could lead to advancements in the treatment and management of urologic cancers. Our ability to achieve and expand our success in these partnerships and collaborations will depend on several factors, including our ability to convince the pharmaceutical, medical and scientific community and collaborators of the utility and benefits of using our products and Decipher GRID as opposed to competitors’ products and technologies. In addition, the continued expansion of Decipher GRID is dependent upon third parties’ willingness to share prospective outcome data for use within Decipher GRID, and such data may not be available to us.

Our research and development activities and the continued growth and further development of Decipher GRID require access to tissue samples and other biological materials and without such access our business may suffer.

To pursue our research and development programs, as well as to continue to grow and further develop Decipher GRID, we require access to human cancer tissue samples, other biological materials and related clinical or other information. We believe access to new samples and related patient information will be critical to the further growth and development of Decipher GRID, our research and development activities with respect to new

 

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genomic tests and to the improvement of our existing products and our ability to conduct studies to validate our products.

We rely on our commercial operations and our clinical and scientific partnerships, as well as pharmaceuticals companies, to access new tissue samples and related patient data. If we are unable to access the tissue samples necessary for our research and development programs, or if tighter regulatory restrictions are imposed on our use of the data generated from or affiliated with such samples, this could impair the utility of Decipher GRID and our ability to conduct our research and development activities as planned, as well as impair our ability to expand our product offerings going forward.

If we cannot compete successfully, we may be unable to increase or sustain our revenue or achieve and sustain profitability.

Our principal competition comes from traditional clinical and pathology staging criteria, such as the NCCN risk groups, which has been the standard of care in the United States for many years. It may be difficult to change the methods or behavior of physicians to incorporate our Decipher-based testing, including genomic testing, in their practices in conjunction with or instead of tissue biopsies and analysis.

In addition to competition from traditional diagnostic methods, we also face competition from companies that offer products or are conducting research to develop products for molecular diagnosis for urologic cancers. In particular, for clinical questions associated with active surveillance or definitive therapy (surgery or radiation therapy) in Very Low, Low and Favorable Intermediate NCCN risk groups, we compete with Exact Sciences Corporation’s Oncotype Dx prostate cancer test and Myriad Genetics, Inc.’s prostate cancer test.

We are also aware of late-stage work being performed to develop and validate a product that could compete with Decipher Biopsy for some mCRPC therapy selection tests, which may include competition from Foundation Medicine, Inc. and Myriad Genetics for prediction of PARP inhibitors and of an existing product from Genomic Health for prediction of chemotherapy selection. In the future, we may also face competition from companies developing new products and technologies.

In addition, if our competitors successfully develop and market in vitro diagnostic, or IVD, test kit versions of their diagnostic tests for prostate cancer, our ability to successfully compete may be limited unless and until we develop IVD test kit versions of our genomic tests because physicians may be significantly impacted especially if market dynamics change in favor of IVD test kits which physicians may prefer for various reasons, including in-office testing convenience. In addition, IVD test kits may facilitate commercial efficiencies as well as broader patient access, which may give any of our competitors who successfully develop an IVD test kit version of their diagnostic tests a competitive advantage over us. We do not presently plan to develop IVD test kit versions of our genomic tests due to the significant capital expenditures that would be required.

The genomic testing industry is characterized by rapidly advancing technologies, intense competition and strong emphasis on proprietary products. Some of our competitors, either alone or with their strategic partners, have substantially greater financial, technical and human resources than we do. Mergers and acquisitions may result in even more resources being concentrated in our competitors. These same competitors may invent technology that competes with our products. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and participating in clinical trials.

Additionally, projects related to cancer diagnostics and particularly genomics have received increased private and government funding, both in the United States and internationally. These projects, as well as publicly accessible or privately maintained databases, may be competitive with or decrease the attractiveness of using Decipher GRID. Moreover, personalized genomics is a developing area of science and we cannot predict what other platforms may be developed that may compete with or provide results comparable with or superior to the results we are able to achieve. Further, as more information regarding cancer genomics becomes available, we

 

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anticipate that more products aimed at identifying targeted treatment options will be developed and that these products may compete with our products. Competitors also may develop their own versions of our current or planned genomic tests in countries where we did not apply for patents or where our patents have not issued and compete with us in those countries, including encouraging the use of their tests by physicians or patients in other countries.

Some of our present and potential competitors have widespread brand recognition and substantially greater financial and technical resources and development, production and marketing capabilities than we do. Others may develop lower-priced, less complex tests that payors, pathologists and oncologists and other physicians could view as functionally equivalent to our current or planned genomic tests, which could force us to lower the list price of our tests and impact our operating margins and our ability to achieve and maintain profitability. In addition, technological innovations that result in the creation of enhanced diagnostic tools that are more effective than ours may enable other clinical laboratories, hospitals, physicians or medical providers to provide specialized diagnostic tests similar to ours in a more patient-friendly, efficient or cost-effective manner than is currently possible. If we cannot compete successfully against current or future competitors, we may be unable to increase or create market acceptance and sales of our current or planned genomic tests, which could prevent us from increasing or sustaining our revenue or achieving or sustaining profitability.

The sizes of the markets for our current and future products have not been established with precision and may be smaller than we estimate.

Our estimates of the total market opportunity for our current and future genomic tests in urologic cancers and the use of our tests in transcriptomic profiling clinical trials in urologic cancers are based on a number of internal and third-party estimates, including, without limitation, the annual rate of patients with the applicable form of urologic cancer, the list price of our products relative to the reimbursement we expect to receive from third-party payors and the assumed prices at which we can sell our products in markets that have not been established. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, our estimates of the annual total market opportunity for our current or future products may prove to be incorrect. If the actual number of patients who would benefit from our products, the price at which we can sell future products, or the annual total market opportunity for our products is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.

Interim, topline and preliminary data from our clinical trials or clinical trials involving our genomic tests that we or others announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, we or third parties with whom we collaborate may publicly disclose preliminary or topline or data from our clinical trials or clinical trials involving our genomic tests, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular clinical trial. We or the third-party collaborator announcing these results make assumptions, estimations, calculations and conclusions as part of the analyses of data, and we or the third-party collaborator may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that we or others report may differ from future results of the same clinical trials, or different conclusions or considerations may qualify such results, once additional data has been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we or third-party collaborators may also disclose interim data from our clinical trials or from clinical trials involving our genomic tests. Interim data from these clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as more patient data become available. Adverse differences between preliminary or interim data and final data could significantly harm our reputation and marketing efforts.

 

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Further, others, including healthcare providers or payors, may not accept or agree with our or our third-party collaborators’ assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular genomic test and our company in general. In addition, the information we or others choose to publicly disclose regarding a particular clinical trial is based on what is typically extensive information, and you or others may not agree with what we or a third-party collaborator determine is the material or otherwise appropriate information to include in our disclosure, and any information we or our third-party collaborators determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding our business. If the topline or interim data that we or third-party collaborators report differ from actual results, or if others, including healthcare providers or payors, disagree with the conclusions reached, our ability to commercialize our genomic tests may be harmed, which could harm our business, operating results, prospects or financial condition.

Our future success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel.

We are highly dependent on the members of our executive team listed under “Management” located elsewhere in this prospectus, the loss of whose services may adversely impact the achievement of our objectives. While we have entered into employment agreements with certain of our executive officers, any of our executive officers could leave our employment at any time, as all of our employees are “at will” employees. Recruiting and retaining other qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to our success.

Although we have not historically experienced difficulties attracting and retaining qualified employees, we could experience such problems in the future. For example, competition for qualified personnel in the life sciences and biotechnology fields is intense due to the limited number of individuals who possess the skills and experience required by our industry. There is currently a shortage of skilled executives in our industry, which is likely to continue. As a result, competition for skilled personnel is intense and the turnover rate can be high. We will need to hire additional personnel as we expand our clinical development and commercial activities. We may not be able to attract and retain personnel on acceptable terms, or at all, given the competition among numerous life sciences and biotechnology companies for individuals with similar skill sets. In addition, failure to demonstrate the utility of our genomic tests in the clinical setting may make it more challenging to recruit and retain qualified personnel. The inability to recruit or loss of the services of any executive, key employee, consultant or advisor may impede the progress of our research, development and commercialization objectives. Furthermore, companies in our industry whose employees accept positions with competitors frequently claim that those competitors have engaged in unfair hiring practices. To the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output.

Our failure to continue to attract, hire and retain a sufficient number of qualified sales professionals would hamper our ability to increase demand for our genomic tests, to expand geographically and to successfully commercialize any other tests or products we may develop.

To succeed in selling our genomic tests, we must expand our sales force by recruiting additional sales representatives with extensive experience in oncology and established relationships with urologists, medical oncologists, surgeons, oncology nurses, pathologists and other hospital personnel. To achieve our marketing and sales goals, we will need to continue to build our sales and commercial infrastructure, with which to date we have had limited experience. In August 2019, we initiated a sales expansion strategy to grow our sales team from 12 sales representatives to approximately 25 by the end of 2020. However, sales professionals with the necessary technical and business qualifications are in high demand, and there is a risk that we may be unable to attract, hire and retain the number of sales professionals with the right qualifications, scientific backgrounds and relationships with decision-makers at potential customers needed to achieve our sales goals. We expect to face competition

 

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from other companies in our industry, some of whom are much larger than us and who can pay greater compensation and benefits than we can, in seeking to attract and retain qualified sales and marketing employees. Our business will be adversely impacted if we are unable to hire and retain qualified sales and marketing personnel.

If we do not achieve, sustain or successfully manage our growth, our business and ability to execute our business strategy may be harmed.

Our genomic testing revenue increased from $10.7 million in 2018 to $16.0 million in 2019, or a 50% increase. Our genomic testing revenue increased from $10.1 million for the nine months ended September 30, 2019 to $27.4 million in the comparable period in 2020, or an increase of 170%. We may not achieve similar revenue growth rates in future periods. Therefore, investors should not rely on our recent revenue growth or results of operations for any prior periods as an indication of our future operating performance. If we are unable to maintain adequate revenue growth, our financial results could suffer and the market price of our common stock may decline.

The growth of our business and operations has imposed, and may continue to impose, significant demands on our management team as well as on our operational and internal controls. Further, as we continue to grow we must also implement necessary increases in testing capacity, scale-related improvements, including information technology and other infrastructure, control processes and quality assurance processes. Our efforts to grow our commercial operations may negatively affect the quality of our test results, may prevent us from performing tests on a timely basis at a level consistent with demand or we may be unsuccessful in responding to the growing complexity of our testing operations. Effective management of our growth will require, among other things:

 

   

successful implementation of financial and internal control reporting systems, in particular to correct any significant deficiencies in our internal controls;

 

   

successful integration of new employees in our sales and marketing team who are familiar with our product offerings and understand the complexity of the new generation of genomic testing;

 

   

improving systems and procedures required for reimbursement from certain governmental and commercial payors;

 

   

a continuous upgrade and expansion of our equipment and information technology capabilities;

 

   

hiring, training and retaining new employees, particularly for our U.S.-based sales and marketing team, as well as clinical laboratory scientists and technical staff acquainted with new technologies, employees with regulatory knowledge and experience in the field of bioinformatics, and customer service, laboratory, legal and financial personnel;

 

   

maintaining regulatory clearances, standards of quality and high customer satisfaction levels;

 

   

monitoring the complex and changing regulatory environment in the United States, Canada, the European Union, or EU, and other jurisdictions where we operate or intend to operate;

 

   

securing appropriate additional laboratory space on commercially reasonable terms;

 

   

forecasting demand for our genomic tests and managing anticipated expenses accordingly; and

 

   

effective co-ordination among our management, sales, technical, legal and finance personnel.

If we encounter difficulties meeting market demand or ensuring quality standards for our genomic tests, or if we otherwise fail to manage our expansion effectively by correcting identified deficiencies in our internal controls or in other respects, our reputation could be harmed and our future prospects and business could suffer, which may have a material adverse effect on our business, financial condition results of operations and cash flows.

 

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We rely on a limited number of third parties for manufacture and supply of all of our laboratory instruments and materials, including consumables, and we may not be able to find replacement suppliers or manufacturers in a timely manner in the event of any disruption, which could adversely affect our business.

Several of the consumable supplies and reagents and certain equipment used in our testing process are procured from a limited number of suppliers, or in some cases a single supplier. These single-source suppliers of certain equipment and reagents include Affymetrix, Inc., or Affymetrix (a subsidiary of Thermo Fisher Scientific Inc., or Thermo Fisher). If Affymetrix breaches their supply agreement with us, or if the agreement is terminated or is not renewed at the end of its term, we will need to identify an alternative supplier for the equipment and reagents currently supplied by Affymetrix, which may result in delays that could materially adversely affect our business.

Other than Affymetrix, we do not presently have supply agreements with any of our suppliers and instead purchase reagents and materials on a purchase order basis. As such, these suppliers are not contractually committed to supply equipment and materials to us. Because we cannot ensure the actual production or manufacture of such critical equipment and materials, or the ability of our suppliers to comply with applicable legal and regulatory requirements, we may be subject to significant delays caused by interruption in production or manufacturing.

If any of our third-party suppliers were to become unwilling or unable to provide equipment or materials in required quantities, or on our required quality or timelines, or if we desire to change suppliers for business reasons, we would need to identify and acquire acceptable replacement sources on a timely basis. Even if we were to identify other suppliers for such equipment and materials, we may not be able to obtain such items on a timely basis or on acceptable terms, if at all.

If we encounter delays or difficulties in securing necessary laboratory equipment or materials, including consumables, we could face an interruption in our ability to perform testing services. Any such interruption may significantly affect our future revenue, cause us to incur higher costs, and harm our customer relationships and reputation. In addition, in order to mitigate these risks, we maintain inventories of these supplies at higher levels than would be the case if multiple sources of supply were available. If our testing volume decreases or we switch suppliers, we may hold excess supplies with expiration dates that occur before use which would adversely affect our losses and cash flow position. As we introduce any new genomic testing products, we may experience supply issues as we ramp test volume. If we should encounter delays or difficulties in securing, reconfiguring or revalidating the equipment, reagents or other materials we require for our products, our business, financial condition, results of operations and reputation could be adversely affected.

We rely on courier delivery services to transport samples to our facility for analysis. If these delivery services are disrupted, our business and customer satisfaction could be negatively impacted.

Clinicians and clinical laboratories ship samples to us by air and ground express courier delivery service for analysis at our San Diego facility. Disruptions in delivery service, whether due to bad weather, natural disaster, public health epidemics or pandemics (including the ongoing COVID-19 pandemic), terrorist acts or threats, or for other reasons, could adversely affect specimen quality and our ability to provide our services on a timely basis to customers.

We may be sued for product liability or professional liability and could face substantial liabilities that exceed our resources, or we may initiate corrections of our tests, which could have a material adverse impact on our business or reputation.

The marketing, sale and use of our current genomic tests and our planned future genomic tests could lead to the filing of product liability claims against us if someone alleges that our tests failed to perform as designed. We may also be subject to liability for errors in the test results we provide to physicians or for a misunderstanding of, or inappropriate reliance upon, the information we provide. A product liability or professional liability claim could result in substantial damages and be costly and time-consuming for us to defend.

 

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Although we believe that our existing product and professional liability insurance is adequate, our insurance may not fully protect us from the financial impact of defending against product liability or professional liability claims. Any product liability or professional liability claim brought against us, with or without merit, could increase our insurance rates or prevent us from securing insurance coverage in the future. Additionally, any product liability lawsuit could damage our reputation or cause current partners to terminate existing agreements and potential partners to seek other partners, any of which could impact our results of operations.

We may also initiate a correction of our genomic tests, which could lead to increased costs and increased scrutiny by regulatory authorities and our customers regarding the quality and safety of our genomic tests, as well as negative publicity. The occurrence of any of these events could have an adverse effect on our business and results of operations.

If we use hazardous materials in a manner that causes injury, we could be liable for damages.

Our activities currently require the controlled use of potentially harmful materials and chemicals. We cannot eliminate the risk of accidental contamination or injury to employees or third parties from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for any resulting damages, and any liability could exceed our resources or any applicable insurance coverage we may have. Additionally, we are subject to, on an ongoing basis, federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations may become significant and could have a material adverse effect on our financial condition, results of operations and cash flows. In the event of an accident or if we otherwise fail to comply with applicable regulations, we could lose our permits or approvals or be held liable for damages or penalized with fines.

Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.

We depend on information technology and telecommunications systems for significant aspects of our operations. These information technology and telecommunications systems support a variety of functions, including test processing, sample tracking, quality control, customer service and support, billing and reimbursement, research and development activities and our general and administrative activities. Information technology and telecommunications systems are vulnerable to damage from a variety of sources, including telecommunications or network failures, malicious human acts and natural disasters. Cyberattacks and other malicious internet-based activity continue to increase. The techniques used to sabotage or to obtain unauthorized access to our systems, networks and/or physical facilities in which data is stored or through which data is transmitted change frequently, and we may be unable to implement adequate preventative measures or stop security breaches while they are occurring. Moreover, despite the implementation of network security and back-up measures, some of our servers are potentially vulnerable to damage or unauthorized access or use, computer viruses, malware, cyber-attacks or cyber-intrusions over the Internet, denial or degradation of service attacks, ransomware, hacking, phishing and other social engineering attacks, attachments to emails or similar disruptive problems and to persons inside our organization or persons with access to systems inside our organization.

In the ordinary course of our business, we collect and store sensitive data, including legally protected individually identifiable health information, personally identifiable information about our employees, customers and patients, intellectual property, and our proprietary business information and that of our customers, payors and collaboration partners. We manage and maintain our applications and data utilizing a combination of on-site systems, managed data center systems and cloud-based data center systems. These applications and data encompass a wide variety of business-critical information including research and development information, commercial information and business and financial information. We face four primary risks relative to protecting

 

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this critical information, including loss of access risk, inappropriate disclosure risk and inappropriate modification risk combined with the risk of our being able to identify and audit our controls over the first three risks.

The secure processing, storage, maintenance and transmission of this critical information are vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take measures to protect sensitive information from unauthorized access or disclosure, our information technology and infrastructure, and that of our third-party billing and collections provider, may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance or other disruptions. The recovery systems, security protocols, network protection mechanisms and other security measures that we have integrated into our systems, networks and physical facilities, which are designed to protect against, detect and minimize security breaches, may not be adequate to prevent or detect service interruption, system failure or data loss. Our platform, applications, systems, networks, and physical facilities could be breached or personal information could be otherwise compromised due to employee error or malfeasance, if, for example, third parties attempt to fraudulently induce our employees or our customers to disclose information or user names and/or passwords, or otherwise compromise the security of our platform, networks, systems and/or physical facilities. Third parties may also exploit vulnerabilities in, or obtain unauthorized access to, platforms, applications, systems, networks and/or physical facilities utilized by our vendors. While we have not experienced any such material system failure or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our business operations, and the privacy or confidentiality of the information that we maintain. Any such breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, significant remediation or litigation costs, liability under laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and regulatory penalties, and divert attention of management and key information technology resources. Unauthorized access, loss or dissemination could also disrupt our operations, including our ability to process tests, provide test results, bill payors or patients, process claims and appeals, provide customer assistance services, conduct research and development activities, collect, process and prepare company financial information, provide information about our genomic tests and other patient and physician education and outreach efforts through our website, manage the administrative aspects of our business and damage our reputation, any of which could adversely affect our business, result in increased costs or loss of revenue, or result in significant financial exposure.

In addition, we rely on Decipher GRID to drive product development for us and our pharmaceutical partners. If we were to lose Decipher GRID or if the database were compromised, our ability to develop a portfolio of innovative products, including through partnering with investigators, drug developers and academic institutions, could be significant impaired.

The costs to respond to a security breach and/or to mitigate any security vulnerabilities that may be identified could be significant, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service, negative publicity, and other harm to our business and our competitive position. In addition, the costs of maintaining or upgrading our cyber-security systems at the level necessary to keep up with our expanding operations and prevent against potential attacks are increasing, and despite our best efforts, our network security and data recovery measures and those of our vendors may still not be adequate to protect against such security breaches and disruptions, which could cause harm to our business, financial condition and results of operations. Any security breach affecting us, our partners or our industry, whether real or perceived, could harm our reputation, erode confidence in the effectiveness of our security measures and lead to regulatory scrutiny. Likewise, we may rely on third parties for our business operations, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or

 

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applications, or inappropriate disclosure of confidential or proprietary information, we could face governmental reporting obligations, incur liability and experience material disruptions of our business operations.

We have contractual and legal obligations to notify relevant stakeholders of security breaches. Most jurisdictions have enacted laws requiring companies to notify individuals, regulatory authorities, and others of security breaches involving certain types of data. In addition, our agreements with certain customers and partners may require us to notify them in the event of a security breach. Such mandatory disclosures are costly, could lead to negative publicity, may cause our customers to lose confidence in the effectiveness of our security measures and require us to expend significant capital and other resources to respond to and/or alleviate problems caused by the actual or perceived security breach, and may cause us to breach customer contracts. Depending on the facts and circumstances of such an incident, these damages, penalties and costs could be significant and may not be covered by insurance or could exceed our applicable insurance coverage limits. Such an event also could harm our reputation and result in litigation against us. Any of these results could materially adversely affect our financial performance. Our agreements with certain customers may require us to use industry-standard or reasonable measures to safeguard sensitive personal information or confidential information. A security breach could lead to claims by our customers, or other relevant stakeholders that we have failed to comply with such legal or contractual obligations. As a result, we could be subject to legal action or our customers could end their relationships with us. There can be no assurance that any limitations of liability in our contracts would be enforceable or adequate or would otherwise protect us from liabilities or damages.

Litigation resulting from security breaches may adversely affect our business. Unauthorized access to our applications, systems, networks, or physical facilities could result in litigation with our customers or other relevant stakeholders. These proceedings could force us to spend money in defense or settlement, divert management’s time and attention, increase our costs of doing business, or adversely affect our reputation. We could be required to fundamentally change our business activities and practices or modify our operations in response to such litigation, which could have an adverse effect on our business.

If we fail to detect or remediate a security breach in a timely manner, or a breach otherwise affects a large amount of data, or if we suffer a cyber-attack that impacts our ability to operate our applications, systems, networks, or physical facilities, we may suffer material damage to our reputation, business, financial condition, and results of operations. Further, our insurance coverage may not be adequate for data security, indemnification obligations, or other liabilities. Depending on the facts and circumstances of such an incident, the damages, penalties and costs could be significant and may not be covered by insurance or could exceed our applicable insurance coverage limits.

We may not have adequate insurance coverage. The successful assertion of one or more large claims against us that exceeds our available insurance coverage, or results in changes to our insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), could have an adverse effect on our business. In addition, we cannot be sure that our existing insurance coverage and coverage for errors and omissions will continue to be available on acceptable terms or that our insurers will not deny coverage as to any future claim. Our risks are likely to increase as we continue to expand and process, store, and transmit increasingly large amounts of proprietary and sensitive data.

We may acquire other businesses or form joint ventures or make investments in other companies or technologies that could harm our operating results, dilute our stockholders’ ownership, increase our debt or cause us to incur significant expense.

It is possible that we may pursue acquisitions of businesses and assets from time to time. We also may pursue strategic alliances and joint ventures that leverage our core technology and industry experience to expand our product offerings or distribution. We have no experience with acquiring other companies and limited experience with forming strategic alliances and joint ventures. We may not be able to find suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all. If we

 

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make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we could assume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debt and contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations and cash flows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focus on developing our existing business. We may experience losses related to investments in other companies, which could have a material negative effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance or joint venture.

To finance any acquisitions or joint ventures, we may choose to issue our common stock as consideration, which would dilute the ownership of our stockholders. If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project using our shares as consideration.

Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings of debt or other equity. Additional funds may not be available on terms that are favorable to us, or at all.

International expansion of our business would expose us to additional business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.

We currently conduct business activities in the United States and Canada, with limited product sales through distributors in other territories. We may pursue international expansion, including expansion of our genomic testing outside of the United States. Doing business internationally involves a number of risks, including:

 

   

multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses, including changes as a result of Brexit;

 

   

failure by us or our distributors to obtain regulatory approvals for the sale or use of our current tests and our planned future genomic tests in various countries;

 

   

difficulties in successfully attracting, developing and retaining foreign sales or distribution channels and in managing foreign operations;

 

   

complexities associated with securing adequate reimbursement from payors;

 

   

logistics and regulations associated with shipping patient samples, including infrastructure conditions and transportation delays;

 

   

limits on our ability to penetrate international markets if our current and our planned future genomic tests cannot be processed by an appropriately qualified local laboratory;

 

   

financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;

 

   

reduced protection for intellectual property rights, or lack of them in certain jurisdictions, forcing more reliance on our trade secrets, if available;

 

   

natural disasters, political and economic instability, including wars, terrorism and political unrest, boycotts, curtailment of trade and other business restrictions;

 

   

disruptions to us or our strategic partners, third-party manufacturers, suppliers and other third parties upon which we rely resulting from the impact of public health epidemics or pandemics (including the ongoing COVID-19 pandemic); and

 

   

failure to comply with the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, by maintaining accurate information and control over sales activities and distributors’ activities.

 

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Any of these risks, if encountered, could significantly harm our future international expansion and operations and, consequently, have a material adverse effect on our financial condition, results of operations and cash flows.

Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn could result in a variety of risks to our business, including weakened demand for our genomic tests and a decreased ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption, or cause our customers to delay making payments for our services. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

Reimbursement Risks Relating to Our Business

Our business depends on our ability to obtain and maintain adequate reimbursement from government healthcare programs and other third-party payors.

Reimbursement for our genomic tests from government healthcare programs and other third-party payors represents substantially all of our genomic testing revenue. For the years ended December 31, 2018 and December 31, 2019, approximately 30% and 47%, respectively, of our revenue was derived from Medicare patients. During the nine months ended September 30, 2020, approximately 51% of our revenue was derived from Medicare patients. We expect government healthcare programs such as Medicare and other third-party payors such as commercial insurance companies to continue to be our most significant source of revenue going forward. Physicians may be reluctant to order the use of our products due to the substantial potential cost to the patient if coverage is unavailable or reimbursement amounts are inadequate. Decipher Biopsy and Decipher RP are currently reimbursed by Medicare pursuant to local coverage determinations, or LCDs, issued by Palmetto GBA and adopted by Noridian Healthcare Solutions, each acting as a Medicare Administrative Contractor, or MAC, as well as by a number of commercial payors. However, there are many commercial payors who currently do not provide reimbursement for our genomic tests, or provide only limited reimbursement, and we have contracts for reimbursement with only a limited number of commercial payors. We have not yet secured a Medicare coverage determination nor have we contracted with any commercial payors for reimbursement of Decipher Bladder. We are actively engaged in efforts to achieve broad commercial coverage and reimbursement for our current and future products, followed by contracting with commercial payors. Achieving positive coverage reduces the need for appeals and reduces failures to collect from the patient’s commercial payor. Even with positive coverage decisions, we still experience delays in time to payment. Achieving in-network contracts with third-party payors can shorten the time required to receive payments. Implementing our strategy includes our managed care and medical affairs teams educating third-party payors regarding our strong clinical utility and outcomes data, which we believe validates the value of our products and will persuade more third-party payors to provide value-based reimbursement.

If we are unable to obtain or maintain coverage and adequate reimbursement from government and third-party payors for our existing or future products, our ability to generate revenue could be limited. Coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. From time to time various payors may publish negative coverage decisions or decline to reimburse us adequately with respect to one or more of our tests.

The reimbursement environment for genomic testing is constantly evolving. Outside of the United States, we have not yet established reimbursement coverage for our products from governmental or commercial third-

 

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party payors. If we are unable to broaden reimbursement coverage for our products with payors, our financial condition, results of operations and cash flows would be materially adversely affected. For example, our Decipher tests were assigned a new CPT code for 2020, which resulted in a new Medicare payment amount being assigned, effective January 1, 2021. Any material decrease in the new per-test reimbursement amount as a result of these changes could adversely affect our business, results of operations and financial condition.

Reimbursement processes of Medicare, Medicaid and/or other payors, or payment delays, could hurt our cash flows and increase our need for working capital.

Medicare and Medicaid have complex billing and documentation requirements that we must satisfy in order to receive payment, and the programs audit and monitor our compliance with these requirements. We must also comply with numerous other laws applicable to billing and payment for healthcare services, including, for example, false claims and data privacy and security laws. Failure to comply with these requirements may result in, among other things, non-payment, delays in payment, refunds, exclusion from government healthcare programs, reputational harm, disgorgement, fines, significant penalties, and administrative, civil or criminal liabilities, any of which may have a material adverse effect on our revenue and earnings. In addition, failure by payors to properly process our payment claims in a timely manner could delay our receipt of payment for our products and services, which may have a material adverse effect on our cash flows.

Billing for our products is complex and requires substantial time and resources to collect payment.

Billing for clinical laboratory testing services is complex, time-consuming and expensive. Depending on the billing arrangement and applicable law, we bill various payors, including Medicare, Medicaid, private insurance companies, private healthcare institutions, and patients, all of which have different billing requirements. We generally bill third-party payors for products and pursue reimbursement on a case-by-case basis where pricing contracts are not in place. To the extent laws or contracts require us to bill patient co-payments or co-insurance, we must also comply with these requirements. We may also face increased risk in our collection efforts, including potential write-offs of accounts receivable and long collection cycles, which could adversely affect our business, results of operations and financial condition.

Several factors make the billing process complex, including:

 

   

differences between the billing rates and reimbursement rates for our products;

 

   

compliance with complex federal and state regulations related to billing government healthcare programs, including Medicare and Medicaid;

 

   

risk of government and commercial audits related to billing;

 

   

disputes among payors as to which party is responsible for payment;

 

   

differences in coverage and information and billing requirements among payors, including the need for prior authorization and/or advanced notification;

 

   

the effect of patient co-payments or co-insurance and our ability to collect such payments from patients;

 

   

changes to billing codes used for our products;

 

   

changes to requirements related to our current or future clinical trials, including our registry studies, which can affect eligibility for payment;

 

   

ongoing monitoring provisions of LCDs for our products, which can affect the circumstances under which a claim would be considered medically necessary;

 

   

incorrect or missing billing information; and

 

   

the resources required to manage the billing and claims appeals process.

 

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We use standard industry billing codes, known as CPT codes, to bill for our products. Our Decipher tests were assigned a new CPT code for 2020. CPT code changes can result in a risk of an error being made in the claim adjudication process. Such errors can occur with claims submission, third-party transmission or in the processing of the claim by the payor. Claim adjudication errors may result in a delay in payment processing or a reduction in the amount of the payment we receive.

As we introduce new products, we may need to add new codes to our billing process as well as our financial reporting systems. Failure or delays in effecting these changes in external billing and internal systems and processes could negatively affect our collection rates, revenue and cost of collecting.

Additionally, our billing activities require us to implement compliance procedures and oversight, train and monitor our employees, and undertake internal audits to evaluate compliance with applicable laws and regulations as well as internal compliance policies and procedures. When payors deny our claims, we may challenge the reason, low payment amount or payment denials. Payors also conduct external audits to evaluate payments, which add further complexity to the billing process. If the payor makes an overpayment determination, there is a risk that we may be required to return all or some portion of prior payments we have received. Additionally, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, enacted in March 2010, requires providers and suppliers to report and return any overpayments received from government payors under the Medicare and Medicaid programs within 60 days of identification. Failure to identify and return such overpayments exposes the provider or supplier to liability under federal false claims laws. These billing complexities, and the related uncertainty in obtaining payment for our products, could negatively affect our revenue and cash flow, our ability to achieve profitability, and the consistency and comparability of our results of operations.

Payors from whom we have received reimbursement may withdraw or decrease the amount of reimbursement provided for our products at any time.

To date, we have received reimbursement from payors who do not have positive coverage determinations or with which we have not yet agreed to payment terms for Decipher tests. Therefore, such payors could withdraw such coverage and stop providing reimbursement for our products in the future, and when they do provide reimbursement for our products, it may be done on a case-by-case basis. Managing reimbursement on a case-by-case basis is time consuming and contributes to an increase in the number of days it takes us to collect accounts receivable and increases our risk of non-payment. Negotiating reimbursement on a case-by-case basis also typically results in the provision of reimbursement at a significant discount to the list price of our products.

Further, even if we have written agreements regarding coverage and reimbursement with certain payors, these agreements do not guarantee indefinite coverage under the same terms or in an adequate amount as coverage and reimbursement decisions may change at any time. Therefore, even if favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future. For example, these agreements are typically terminable without cause by either party and are typically renewable annually, and the applicable payor could opt against renewal upon expiration. In addition, the terms of certain of our written arrangements may require us to seek pre-approval from the payor or put in place other controls and procedures prior to conducting a test for a customer. To the extent we fail to follow these requirements, we may fail to receive some or all of the reimbursement payments to which we are otherwise entitled. These payors must also conclude that our claim satisfies the applicable contractual criteria. In addition, our written agreements regarding reimbursement with payors do not guarantee us the receipt of reimbursement payments at what we believe to be the applicable contracted rate for each reimbursement claim that we submit to such payors. If payors withdraw coverage for our products or reduce the reimbursement amounts for our products, our ability to generate revenue could be limited, which may have a material adverse effect on our financial condition, results of operations and cash flow.

 

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Our commercial success could be compromised if payors or other clients do not pay our invoices, including managed care organizations and Medicare, do not provide coverage and adequate reimbursement, breach, rescind or modify their contracts or reimbursement policies or delay payments for our current genomic tests and our planned future genomic tests.

Physicians may not order our current or planned future genomic tests unless payors, such as managed care organizations and government payors (e.g., Medicare and Medicaid), pay a substantial portion of the test price. Coverage and reimbursement by a payor may depend on a number of factors, including a payor’s determination that tests using our technologies are:

 

   

medically necessary (not experimental and investigational);

 

   

appropriate for the specific patient;

 

   

cost-effective;

 

   

supported by peer-reviewed publications; and

 

   

included in clinical practice guidelines.

Uncertainty surrounds payor coverage and adequate reimbursement of any test incorporating new technology, including tests developed using our technologies. Technology assessments of new medical tests conducted by research centers and other entities may be disseminated to interested parties for informational purposes. Payors and healthcare providers may use such technology assessments as grounds to deny or limit coverage for a test or procedure. Technology assessments can include evaluation of clinical utility studies, which define how a test is used in a particular clinical setting or situation.

Because there is no uniform policy of coverage and reimbursement in the United States, each payor generally determines for its own enrollees or insured patients whether to cover or otherwise establish a policy to reimburse our genomic tests, and seeking payor approvals is a time-consuming and costly process. We cannot be certain that coverage for our current and our planned future genomic tests will be provided in the future by additional payors or that existing agreements, policy decisions or reimbursement levels will remain in place, remain adequate, or be fulfilled under existing terms and provisions. If we cannot obtain coverage and adequate reimbursement from private and governmental payors such as Medicare and Medicaid for our current genomic tests, or new tests or test enhancements that we may develop in the future, our ability to generate revenue could be limited, which may have a material adverse effect on our financial condition, results of operations and cash flow. Further, we may experience delays and interruptions in the receipt of payments from payors due to missing documentation and/or other issues, which could cause delay in collecting our revenue.

In addition, to the extent that our testing is ordered for Medicare inpatients, only the hospital may receive payment from the Medicare program for the technical component of pathology services and for any clinical laboratory services that we perform, unless the testing is ordered at least 14 days after discharge and certain other requirements are met. When our tests are provided on specimens collected from hospital outpatients, some of our tests may only be billed to Medicare by the hospital unless certain requirements are met. We therefore must look to the hospital for payment for these services under these circumstances, as required by CMS. If hospitals refuse to pay for the services or fail to pay in a timely manner, our ability to generate revenue could be limited, which may have a material adverse effect on our financial condition, results of operations and cash flow.

If we are unable to successfully negotiate additional reimbursement contracts, or maintain our current contracts, our commercial success could be compromised.

We are currently considered a “non-contracted provider” by most payors from whom we have sought reimbursement for our genomic tests because we have not entered into a specific contract to provide genomic tests to their insured patients at specified rates of reimbursement. Since each payor makes its own decision as to whether to establish a coverage policy or enter into a contract to reimburse our tests, seeking these approvals is a

 

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time-consuming and costly process. Without a contracted rate for reimbursement, our claims are often denied upon submission, and we must appeal the claims. The appeals process is time consuming and expensive and may not result in payment. In cases where there is not a contracted rate for reimbursement, there is typically a greater patient co-insurance or co-payment requirement which may result in further delay or decreased likelihood of collection. Payors may attempt to recoup prior payments after review, sometimes after significant time has passed, which would impact future revenue. Further, we typically are unable to collect payments from patients beyond that which is paid by their insurance and may experience lost revenue as a result.

We expect to continue to focus substantial resources on increasing adoption, coverage and reimbursement for our current genomic tests and our planned future genomic tests. We believe it will take several years to achieve coverage and contracted reimbursement with a majority of payors. However, we cannot predict whether, under what circumstances, or at what payment levels payors will reimburse us for our products. Furthermore, if we were to become a contracted provider with additional payors in the future, the amount of overall reimbursement we receive would likely decrease because we could be reimbursed a lesser amount per test performed at a contracted rate than at a non-contracted rate, which could have a negative impact on our revenue. Also, payor consolidation is underway and creates uncertainty as to whether coverage and contracts with existing payors will remain in effect. Finally, commercial payors may tie their allowable rates to Medicare rates, and should Medicare reduce their rates, our reimbursement levels may be negatively impacted. Our failure to establish broad adoption of and reimbursement for our current and future genomic tests, or our inability to maintain existing reimbursement from payors, would negatively impact our ability to generate revenue and achieve profitability, as well as our future prospects and our business.

Government healthcare programs and other payors continue to increase their efforts to control the cost, utilization and delivery of healthcare services, which could potentially reduce our rates of reimbursement.

Even if we are being reimbursed for our products, payors may review and adjust the rate of reimbursement, require co-payments from patients or stop paying for our products. Government healthcare programs and other payors continue to increase their efforts to control the cost, utilization and delivery of healthcare services by demanding price discounts or rebates and limiting both coverage on diagnostic products they will pay for and the amounts that they will pay for new genomic testing products. These measures have resulted in reduced payment rates and decreased utilization for the clinical laboratory industry. From time to time, Congress has considered and implemented changes to the Medicare fee schedules in conjunction with budgetary legislation, and pricing and payment terms are subject to change at any time, including the possible implementation of a patient co-payment for Medicare beneficiaries for clinical laboratory tests covered by Medicare,. Because of the cost-containment trends, governmental and commercial payors that currently provide, or may in the future provide, reimbursement for our products may reduce, suspend, revoke or discontinue payments or coverage at any time. Limited coverage or reductions in the prices at which our products are reimbursed may harm our business, financial condition or results of operations.

Regulatory Risks Relating to Our Business

Our genomic tests are currently marketed as Laboratory Developed Tests, and any changes in FDA enforcement discretion, or FDA disagreement that our tests are LDTs, could subject our operations to more significant regulatory requirements and oversight. For example, if the FDA requires us to obtain approval or clearance of our current or future genomic tests, we could incur substantial costs and time delays associated with meeting requirements for premarket clearance or approval or we could experience decreased demand for, or reimbursement of, our tests.

We have not received FDA approval or clearance for any of our genomic tests. Historically, the FDA has exercised enforcement discretion with respect to most Laboratory Developed Tests, or LDTs, and has not required laboratories that furnish LDTs to comply with the agency’s requirements for medical devices (e.g., establishment registration, device listing, quality systems regulations, premarket clearance or premarket

 

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approval, and post-market controls). LDTs are a subset of in vitro diagnostic devices, or IVDs, that are intended for clinical use and are developed, validated and offered within a single laboratory for use only in that laboratory. Our current genomic tests are marketed as LDTs. However, the FDA has previously stated its intention to modify its enforcement discretion policy with respect to LDTs. The FDA could ultimately modify its current approach to LDTs in a way that would subject our tests marketed as LDTs to the requirements of the FDA applicable to other categories of medical devices. Moreover, legislative measures have been proposed in Congress that, if ultimately enacted, could provide the FDA with additional authority to require premarket review of and regulate LDTs. If and when such changes to the regulatory framework or the FDA’s enforcement thereof occur, we could for the first time be subject to enforcement of regulatory requirements as a device manufacturer such as registration and listing requirements, requirements for premarket clearance or approval of our genomic tests, medical device reporting requirements and the requirements of the FDA’s Quality System Regulation, among others. Even if the FDA does not modify its policy of enforcement discretion, the FDA may disagree that we are marketing our LDTs within the scope of its current regulations and policies. A determination that we have violated these laws and regulations, or a public announcement that we are being investigated for possible violations, could adversely affect our business, prospects, results of operations and financial condition. If there are changes in the regulatory framework with respect to LDTs, we may be subject to significant additional regulatory requirements.

In addition, if increased oversight of genomic testing were to result in further regulatory burdens, they could negatively affect our business and delay the commercialization of tests in development.

If the FDA were to actively regulate our diagnostic tests, we may be required to obtain premarket clearance under Section 510(k) of the Federal Food, Drug and Cosmetic Act, or FDCA, or a premarket approval, or PMA, for our tests. The requirement of premarket review could negatively affect our business until such review is completed and clearance to market or approval is obtained. The FDA could require that we stop selling our genomic tests pending premarket clearance or approval. If the FDA allows our tests to remain on the market but there is uncertainty about our tests, if they are labeled investigational by the FDA or if labeling claims the FDA allows us to make are very limited, orders from physicians or reimbursement may decline. The regulatory approval process may involve, among other things, successfully completing additional clinical trials and making a 510(k) submission or filing a PMA or de-novo application with the FDA. If the FDA requires premarket review, our tests may not be cleared or approved on a timely basis, if at all. We may also decide voluntarily to pursue FDA premarket clearance or approval of our tests if we determine that doing so would be appropriate.

In addition to requiring premarket review, our tests would likely be subject to additional regulations. The regulatory requirements specific to medical devices are wide ranging and govern, among other things:

 

   

product design, development, manufacture, and release;

 

   

laboratory and clinical testing, labeling, packaging, storage and distribution;

 

   

product safety and efficacy;

 

   

premarketing clearance or approval;

 

   

record keeping;

 

   

product marketing, promotion and advertising, sales and distribution;

 

   

post-marketing surveillance, including reporting of deaths or serious injuries and recalls and correction and removals;

 

   

post-market approval studies; and

 

   

product import and export.

The regulations to which we would be subject are complex and have tended to become more stringent over time. Regulatory changes could result in restrictions on our ability to carry on or expand our operations, higher

 

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than anticipated costs or lower than anticipated sales. The FDA enforces these regulatory requirements through, among other means, periodic unannounced inspections. Moreover, the FDA and state authorities have broad enforcement powers. Our failure to comply with applicable regulatory requirements could result in enforcement action by any such agency, which may include any of the following sanctions:

 

   

adverse publicity, warning letters, untitled letters, it has come to our attention letters, fines, injunctions, consent decrees and civil penalties;

 

   

repair, replacement, refunds, recall or seizure of our products;

 

   

operating restrictions, partial suspension or total shutdown of production;

 

   

denial of our requests for regulatory clearance or PMA of new products or services, new intended uses or modifications to existing products or services;

 

   

withdrawal of regulatory clearance or PMAs that have already been granted; or

 

   

criminal prosecution.

Additionally, should future regulatory actions affect any of the reagents we obtain from suppliers and use in conducting our tests, our business could be adversely affected in the form of increased costs of testing or delays, limits or prohibitions on the purchase of reagents necessary to perform our testing.

If any of these events were to occur, it will negatively affect our business, financial condition and results of operations.

Clinical development involves a lengthy and expensive process with an uncertain outcome. If we were required to conduct additional clinical studies or trials before continuing to offer tests that we have developed or may develop as LDTs, those studies or trials could lead to delays or failure to obtain necessary regulatory approval, which could cause significant delays in commercializing any future products and harm our ability to achieve sustained profitability.

If the FDA requires that we obtain clearance or approval to commercialize our current genomic tests or our planned future genomic tests, we may be required to conduct additional premarket clinical testing before submitting a regulatory notification or application for commercial sales. In addition, as part of our long-term strategy we may seek FDA clearance or approval so we can sell our genomic tests outside our CLIA laboratory; however, we would need to conduct additional clinical validation activities, including the possibility of clinical trials, on our genomic tests before we can submit an application for FDA approval or clearance. Clinical trials must be conducted in compliance with FDA regulations or the FDA may take enforcement action or reject the data. The data collected from these clinical trials may ultimately be used to support market clearance or approval for our tests, but the FDA may disagree with the design of the studies or may interpret the data differently than we do. We believe it would likely take two years or more to conduct the clinical studies and trials necessary to obtain clearance or approval from the FDA to commercially launch our current genomic tests and our planned future genomic tests. Even if our clinical trials are completed as planned, we cannot be certain that their results will support our test claims or that the FDA or foreign authorities will agree with our conclusions regarding our test results.

Success in early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior clinical trials and studies. If we are required to conduct clinical trials to support FDA clearance or approval to market our genomic tests, whether using prospectively acquired samples or archival samples, delays in the commencement or completion of clinical testing could significantly increase our test development costs and delay commercialization. Many of the factors that may cause or lead to a delay in the commencement or completion of clinical trials may also ultimately lead to delay or denial of regulatory clearance or approval. The commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population,

 

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the nature of the protocol, the proximity of patients to clinical sites and the eligibility criteria for the clinical trial. Moreover, the clinical trial process may fail to demonstrate that our current genomic tests and our planned future genomic tests are effective for the proposed indicated uses, which could cause us to abandon a test candidate and may delay development of other tests.

We may find it necessary to engage contract research organizations to perform data collection and analysis and other aspects of our clinical trials, which might increase the cost and complexity of our trials. We may also depend on clinical investigators, medical institutions and contract research organizations to perform the trials properly. If these parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the quality, completeness or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our clinical trials may have to be extended, delayed or terminated. Many of these factors would be beyond our control. We may not be able to enter into replacement arrangements without undue delays or considerable expenditures. If there are delays in testing or approvals as a result of the failure to perform by third parties, our research and development costs would increase, and we may not be able to obtain regulatory clearance or approval for our current genomic tests and our planned future genomic tests. In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of these outcomes would harm our ability to market our genomic tests or to achieve sustained profitability.

Healthcare policy changes, including legislation reforming the U.S. healthcare system, may have a material adverse effect on our financial condition, results of operations and cash flows.

The ACA, enacted in March 2010, made a number of substantial changes in the way healthcare is financed by both governmental and private insurers. Among other ways in which the ACA may continue to impact our business, the ACA includes: provisions regarding coordination and promotion of research on comparative clinical effectiveness of different technologies and procedures; initiatives to revise Medicare payment methodologies; and initiatives to promote quality indicators in payment methodologies.

On December 14, 2018, a U.S. District Court Judge in the Northern District of Texas, or Texas District Court Judge, ruled that the entire Affordable Care Act is invalid based primarily on the fact that the legislation enacted on December 22, 2017, informally known as Tax Cuts and Jobs Act, or the TCJA, repealed the tax-based shared responsibility payment imposed by the ACA, on certain individuals who fail to maintain qualifying health coverage for all or part of a year, which is commonly referred to as the “individual mandate”. Additionally, on December 18, 2019, the U.S. Court of Appeals for the 5th Circuit upheld the District Court ruling that the individual mandate was unconstitutional and remanded the case back to the District Court to determine whether the remaining provisions of the ACA are invalid as well. The United States Supreme Court accepted the case for review and heard oral arguments on November 10, 2020. A decision is expected in 2021. It is unclear how such litigation and other efforts to repeal or revise the ACA will impact our business.

In addition, other legislative changes have been proposed and adopted since the ACA was enacted. For example, the Budget Control Act of 2011, among other things, included aggregate reductions to Medicare payments to providers and suppliers of 2% per fiscal year, starting in 2013, and due to subsequent legislative amendments to the statute, will remain in effect through 2030, with the exception of a temporary suspension from May 1, 2020 through March 31, 2021, unless additional Congressional action is taken. Furthermore, on January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, reduced Medicare payments to several providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

We cannot predict whether future healthcare initiatives will be implemented at the federal or state level, particularly as a result of the recent presidential election, or how any future legislation or regulation may affect us. Further, it is possible that additional governmental action may be taken in response to the COVID pandemic. The expansion of government’s role in the U.S. healthcare industry as a result of the ACA’s implementation, and

 

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changes to the reimbursement amounts paid by Medicare and other payors for our current genomic tests and our planned future genomic tests, may reduce our profits, if any, and have a materially adverse effect on our business, financial condition, results of operations and cash flows. Moreover, Congress has proposed on several occasions to impose a 20% coinsurance payment requirement on Medicare beneficiaries for clinical laboratory tests reimbursed under the Medicare Clinical Laboratory Fee Schedule, which would require us to bill patients for these amounts and may decrease our testing volume. In the event that Congress were to ever enact such legislation, the cost of billing and collecting for our genomic tests could often exceed the amount actually received from the patient.

Under the Protecting Access to Medicare Act of 2014, or PAMA, which was signed into law in April 2014, clinical laboratories subject to the law must report certain data for the Medicare-covered clinical laboratory tests that they furnish. The reported data must include the payment rate (reflecting all discounts, rebates, coupons and other price concessions) and the volume of each test that was paid by each private payor (including health insurance issuers, group health plans, Medicare Advantage plans and Medicaid managed care organizations). The CMS final rule implementing PAMA was issued June 17, 2016 indicating that data reporting for the new PAMA process would begin in 2017 and, beginning in 2018, the Medicare payment rate for covered clinical laboratory tests, with some exceptions, would be based on the weighted median of the reported private third-party payor payments for the test, as calculated using data collected by applicable laboratories during the specified data collection period and reported to CMS during a specified data reporting period. This revised reimbursement methodology has generally resulted in relatively lower reimbursement under Medicare for many clinical diagnostic lab tests than has been historically available. Our next reporting period has been delayed further under the CARES Act and is now January 1, 2024 through March 31, 2024 and will be based on the data collection period of January 1, 2023 through June 30, 2023. We expect the pricing for Decipher Prostate, established under this PAMA reporting cycle, to be in effect from January 1, 2025 through December 31, 2027. CMS clarified that reporting will resume on a three year cycle thereafter (i.e. 2026, 2029, etcetera). The change in reimbursement methodology applicable to our tests under PAMA may reduce our Medicare reimbursement rate and adversely affect our business.

We conduct business in a heavily regulated industry, and complying with numerous regulations pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties or our inability to operate, or we could become subject to administrative or judicial sanctions.

The diagnostics industry is highly regulated, and the laws and regulations governing the marketing of diagnostic tests are extremely complex. Areas of the regulatory environment that may affect our ability to conduct business include, without limitation:

 

   

federal and state laws applicable to test ordering, documentation of tests ordered, billing practices and claims payment and/or regulatory agencies enforcing those laws and regulations;

 

   

federal and state fraud and abuse laws;

 

   

federal and state laboratory anti-mark-up laws;

 

   

coverage and reimbursement levels by Medicare, Medicaid, other governmental payors and private insurers;

 

   

restrictions on coverage of and reimbursement for tests;

 

   

federal and state laws governing laboratory testing, including CLIA, and state licensing laws;

 

   

federal and state laws and enforcement policies governing the development, use and distribution of diagnostic medical devices, including LDTs;

 

   

federal, state and local laws governing the handling and disposal of medical and hazardous waste;

 

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federal and state Occupational Safety and Health Administration rules and regulations; and

 

   

HIPAA and similar state data privacy laws.

In particular, the FDCA defines a medical device to include any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Our diagnostic tests are considered by the FDA to be subject to regulation as medical devices. Among other things, pursuant to the FDCA and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the import and export of medical devices manufactured between the United States and international markets. However, the FDA exercises enforcement discretion with respect to medical devices that are LDTs, which means that tests that fall within the definition of an LDT are not subject to these requirements.

We are also subject to CLIA, a federal law regulating clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease. Our clinical laboratory must be certified under CLIA in order for us to perform testing on human specimens. CLIA is intended to ensure the quality and reliability of clinical laboratories in the United States by mandating specific standards in the areas of personnel qualifications, administration, and participation in proficiency testing, patient test management, quality control, quality assurance and inspections. We have a current CLIA certificate of accreditation to perform high complexity testing. This accreditation is from the College of American Pathologists, or CAP, one of seven CLIA-approved accreditation organizations.

To renew this certificate, we are subject to survey and inspection every two years. Moreover, CLIA inspectors may make periodic inspections of our clinical laboratory outside of the renewal process. The failure to comply with CLIA requirements can result in enforcement actions, including the revocation, suspension, or limitation of our CLIA certificate of accreditation, as well as a directed plan of correction, state on-site monitoring, civil money penalties, civil injunctive suit and/or criminal penalties. We must maintain CLIA compliance and certification to be eligible to bill for tests provided to Medicare and Medicaid beneficiaries. If we were to be found out of compliance with CLIA program requirements and subjected to sanctions, our business and reputation could be harmed. Even if it were possible for us to bring our laboratory back into compliance, we could incur significant expenses and potentially lose revenue in doing so.

In addition, our laboratory is located in California and is required by state law to have a California state license; as we expand our geographic focus, we may need to obtain laboratory licenses from additional states. California laws establish standards for operation of our clinical laboratory, including the training and skills required of personnel and quality control. In addition, we hold licenses from the states of New York, Pennsylvania, Maryland and Rhode Island to test specimens from patients in those states or received from ordering physicians in those states. In New York our services, which are LDTs, must be approved by the New York State Department of Health’s Clinical Laboratory Evaluation Program before they are offered to patients in New York. As part of this test approval process, the State of New York requires validation of our tests. We currently have the necessary New York license and approvals. Other states may have similar requirements or may adopt similar requirements in the future. We may become aware of other states that require out-of-state laboratories to obtain licensure in order to accept specimens from the state. If we become aware of any other state with such requirements, we intend to comply with such requirements. Collecting specimens from a state that requires us to obtain and maintain an out-of-state laboratory license, without receiving such license, or failing to abide by any of our obligations under our existing state licenses may result in sanctions, any of which could harm our business. Finally, we may be subject to regulation in foreign jurisdictions if we seek to expand international distribution of our tests outside the United States.

 

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Failure to comply with applicable clinical laboratory licensure requirements may result in a range of enforcement actions, including suspension, limitation or revocation of our CLIA certificate and/or state licenses, imposition of a directed plan of action, onsite monitoring, civil monetary penalties, criminal sanctions and revocation of the laboratory’s approval to receive Medicare and Medicaid payment for its services, as well as significant adverse publicity.

If we were to lose our CLIA certification or California or other state laboratory license, or have them restricted, whether as a result of a revocation, suspension or limitation, we might no longer be able to offer our tests, which would limit our revenue and harm our business. If we were to lose, or fail to obtain, a license in any other state where we are required to hold a license, we would not be able to test specimens from those states.

The FDA and the Federal Trade Commission, or FTC, also regulate the advertising and promotion of medical devices to ensure that their promotional claims are consistent with the applicable marketing authorizations, that there are adequate and reasonable data to substantiate the claims, and that the promotional labeling and advertising is neither false nor misleading in any respect. If the FDA or FTC determines that any of our promotional claims are false, misleading, not substantiated or not permissible, we may be subject to enforcement action and we may be required to revise our promotional claims and make other corrections or restitutions.

We are subject to numerous federal and state healthcare statutes and regulations, and complying with laws pertaining to our business is an expensive and time-consuming process. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties and a material adverse effect to our business and operations.

Physicians, other healthcare providers and third-party payors play a primary role in the recommendation of our products. Our arrangements with healthcare providers, third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that affect the business and financial arrangements and relationships through which we market and sell our products. The laws that affect our ability to operate include, but are not limited to:

 

   

the federal Anti-Kickback Statute, or the AKS, which prohibits, among other things, any person or entity from knowingly and willfully soliciting, receiving, offering or paying any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of an item or service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value. There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution; however, these are drawn narrowly and require strict compliance in order to offer protection. Additionally, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

   

the federal physician self-referral law, commonly referred to as the Stark Law, prohibits a physician from making a referral for certain designated health services covered by the Medicare or Medicaid program, including laboratory and pathology services, if the physician or an immediate family member of the physician has a financial relationship with the entity providing the designated health services, and further prohibits that entity from billing, presenting or causing to be presented a claim for the designated health services furnished pursuant to the prohibited referral, unless an exception applies;

 

   

federal civil and criminal false claims laws, such as the FCA, prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented false, fictitious or fraudulent claims for payment or approval by the federal government, including federal health care programs, such as Medicare and Medicaid, and knowingly making, using or causing to be made or used a false record or statement material to a false or fraudulent claim, or knowingly making a false statement to

 

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improperly avoid, decrease or conceal an obligation to pay money to the federal government. In addition, a claim including items or services resulting from a violation of the AKS or Stark Law constitutes a false or fraudulent claim for purposes of the FCA. In addition, the failure to refund amounts received as a result of a prohibited referral on a timely basis may constitute a false or fraudulent claim under the FCA. Private individuals can bring False Claims Act “qui tam” actions, on behalf of the government and such individuals, commonly known as “whistleblowers,” may share in amounts paid by the entity to the government in fines or settlement;

 

   

the federal Civil Monetary Penalties law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier;

 

   

the Eliminating Kickbacks in Recovery Act of 2018, or EKRA, prohibits payments for referrals to recovery homes, clinical treatment facilities, and laboratories. EKRA’s reach extends beyond federal health care programs to include private insurance (i.e., it is an “all payor” statute). For purposes of EKRA, the term “laboratory” is defined broadly and without reference to any connection to substance use disorder treatment. The law includes a limited number of exceptions, some of which closely align with corresponding federal AKS exceptions and safe harbors, and others that materially differ;

 

   

HIPAA, which, among other things, imposes criminal liability for executing or attempting to execute a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, in connection with the delivery of or payment for healthcare benefits, items or services. Like the AKS, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

   

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations, which imposes privacy, security and breach reporting obligations with respect to individually identifiable health information upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers, known as covered entities, and their respective business associates, individuals or entities that perform services for them that involve individually identifiable health information as well as their covered subcontractors. HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in U.S. federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions;

 

   

state laws that prohibit other specified practices, such as allowing physicians to purchase and re-bill testing at a mark-up to third-party payors; insurance fraud laws; waiving coinsurance, copayments, deductibles, and other amounts owed by patients; billing a state Medicaid program at a price that is higher than what is charged to one or more other third-party payors or employing, exercising control over or splitting professional fees with licensed professionals in violation of state laws prohibiting fee splitting or the corporate practice of medicine and other professions;

 

   

the federal transparency requirements under the Physician Payments Sunshine Act, created under the ACA, which requires, among other things, certain manufacturers of drugs, devices, biologics and medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program to annually report to CMS information related to payments and other transfers of value provided to physicians, as defined by such law, and teaching hospitals and physician ownership and investment interests, including such ownership and investment interests held by a physician’s immediate family members. Beginning in 2022, applicable manufacturers also will be required to report payments and other transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists,

 

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anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year. We believe that we are exempt from these reporting requirements. We cannot assure you, however, that regulators, principally the federal government, will agree with our determination, and a determination that we have violated these laws and regulations, or a public announcement that we are being investigated for possible violations, could adversely affect our business;

 

   

state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more prohibitive restrictions, and may apply to items or services reimbursed by any non-governmental third-party payors, including private insurers; and

 

   

federal, state and foreign laws that govern the privacy and security of health information or personally identifiable information in certain circumstances, including state health information privacy and data breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts.

In addition, we are also subject to federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

As a clinical laboratory, our business practices may face additional scrutiny from government regulatory agencies such as the Department of Justice, the U.S. Department of Health and Human Services Office of Inspector General, or OIG, and CMS. Certain arrangements between clinical laboratories and referring physicians have been identified in fraud alerts issued by the OIG as implicating the AKS. The OIG has stated that it is particularly concerned about these types of arrangements because the choice of laboratory, as well as the decision to order laboratory tests, typically are made or strongly influenced by the physician, with little or no input from patients. Moreover, the provision of payments or other items of value by a clinical laboratory to a referral source could be prohibited under the Stark Law unless the arrangement meets all criteria of an applicable exception.

The government has been active in enforcement of these laws as they apply to clinical laboratories. In December 2018, we reached an agreement with the Department of Justice, the OIG, the California Department of Insurance and qui tam relators who contended that we submitted claims to the Medicare and Medicaid programs and retained payments for Decipher Prostate tests that were not medically reasonable or necessary for prostate cancer patients that did not have certain risk factors. To resolve the matter, we agreed to pay $2.0 million to the United States and $0.6 million to the State of California, plus relators’ attorney fees and expenses totaling $0.1 million, without any admission of liability or ongoing obligations. In February 2019, we made all settlement payments. In order to help prevent further submissions of claims that may be challenged as inappropriate, we have automated the claim submission process with the intention of improving consistency and compliance in our claim submissions and coding. We believe this change helps mitigate the risk of inaccurate claim submissions going forward. Additionally, we have modified our test acceptance criteria to match our claim submission criteria for Medicare; therefore, testing for Medicare patients is now limited to those tests that we believe meet Medicare coverage criteria. Our addressable market as described elsewhere in this prospectus reflects this modified test acceptance criteria.

We have entered into consulting and scientific advisory board arrangements, speaking arrangements, clinical research and other service agreements with physicians and other healthcare providers, including some who could order or recommend our tests. Because of the complex and far-reaching nature of applicable health care fraud and abuse laws, regulatory agencies may take the view that certain of these transactions are prohibited arrangements that must be restructured, or discontinued, or for which we could be subject to applicable penalties. We could be adversely affected if regulatory agencies interpret our financial relationships with providers who may influence the ordering of and use of our tests to be in violation of applicable laws.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform. Federal and state enforcement bodies have continued their scrutiny of

 

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interactions between healthcare companies, healthcare providers and other third parties, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry. It is possible that governmental authorities may conclude that our business practices, including our consulting and other financial arrangements with physicians, do not comply with current or future statutes, regulations, agency guidance or case law involving applicable healthcare laws. Responding to investigations can be time and resource-consuming and can divert management’s attention from the business. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our business.

Ensuring that our business arrangements with third parties comply with applicable healthcare laws and regulations is costly. If our operations are found to be in violation of any of these laws or any other current or future governmental laws and regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could substantially disrupt our operations. If any of the physicians or other healthcare providers or entities with whom we do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

We are subject to certain U.S. anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations and may become subject to their similar foreign equivalents. As a result, we can face serious consequences for violations.

U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, or collectively, Trade Laws, prohibit, among other things, companies and their employees, agents, legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving, directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We also expect that we may engage in non-U.S. activities over time. We expect to rely on third-party suppliers and/or third parties to obtain necessary permits, licenses, and patent registrations. We can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences.

We may be required to comply with laws governing the transmission, security and privacy of health information that require significant compliance costs, and any failure to comply with these laws could result in material criminal and civil penalties.

Under the administrative simplification provisions of HIPAA, the U.S. Department of Health and Human Services, or HHS, has issued regulations which establish uniform standards governing the conduct of certain electronic healthcare transactions and the protection of individually identifiable health information, including protected health information, or PHI, by certain healthcare providers and other covered entities, and their “business associates,” which are persons or entities that perform certain services for, or on behalf of, a covered entity that involves creating, receiving, maintaining or transmitting PHI as well as their covered subcontractors.

The HIPAA privacy regulations regulate the use and disclosure of PHI by covered entities engaging in certain electronic transactions or “standard transactions.” They also set forth certain rights that an individual has

 

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with respect to his or her PHI maintained by a covered entity, including the right to access or amend certain records containing PHI or to request restrictions on the use or disclosure of PHI, and certain privacy obligations imposed on covered entities. Individuals (or their personal representatives, as applicable) also have the right to access test reports directly from laboratories and to direct that copies of those reports be transmitted to persons or entities designated by the individual. Certain provisions of the HIPAA privacy regulations also apply to business associates and their covered subcontractors.

The HIPAA security regulations establish administrative, physical and technical standards for maintaining the confidentiality, integrity and availability of PHI in electronic form. These standards apply to covered entities, business associates, and their covered subcontractors. The HIPAA privacy and security regulations establish a uniform federal “floor” and do not supersede state laws that are more stringent or provide individuals with greater rights with respect to the privacy or security of, and access to, their records containing PHI. As a result, we may be required to comply with both HIPAA privacy and security regulations and varying state privacy and security laws.

Moreover, HITECH enacted as part of the American Recovery and Reinvestment Act of 2009, among other things, established certain health information security breach notification requirements, which were later further modified by the Final HIPAA Omnibus Rule. In the event of a breach of unsecured PHI, a covered entity must notify each individual whose PHI is breached, federal regulators and in some cases, must publicize the breach in local or national media.

These laws contain significant fines and other penalties for wrongful use or disclosure of PHI. Given the complexity of HIPAA and HITECH and their overlap with state privacy and security laws, and the fact that these laws are rapidly evolving and are subject to changing and potentially conflicting interpretation, our ability to comply with the HIPAA, HITECH and state data privacy and security requirements is uncertain and the costs of compliance are significant.

Adding to the complexity is that our operations are evolving and the requirements of these laws will apply differently depending on such things as whether or not we bill electronically for our services. The costs of complying with any changes to the HIPAA, HITECH and state privacy restrictions and security requirements may have a negative impact on our operations. Noncompliance could subject us to criminal penalties, civil sanctions and significant monetary penalties as well as reputational damage.

Failure to comply with data protection laws and regulations could lead to government enforcement actions, including civil or criminal penalties, private litigation and adverse publicity and could negatively affect our operating results and business.

We may be subject to or affected by data protection laws and regulations, such as laws and regulations that address privacy and data security. In the United States, various federal and state laws and regulations, including federal and state information privacy laws, state data breach notification laws, and federal and state consumer protection laws, including Section 5 of the Federal Trade Commission Act, that govern the collection, use, disclosure and protection of personal information could apply to our operations.

In addition, certain state laws that govern the privacy and security of personal information or health information in certain circumstances may be more stringent than U.S. federal law, differ from each other in significant ways, and may not have the same effect as other state or federal laws, thus complicating compliance efforts. For instance, the California Consumer Privacy Act of 2018, or CCPA, which became effective on January 1, 2020, gives California residents expanded rights including to access and require deletion of their personal information, opt out of sale of certain personal information, and receive detailed information about how their personal information is used. The CCPA authorizes private lawsuits to recover statutory damages for certain data breaches. Although the CCPA exempts data regulated by HIPAA and certain health related data, the CCPA, to the extent applicable to our business and operations, may increase our compliance costs and potential liability

 

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with respect to personal information we maintain about California residents. Additionally, a new privacy law, the California Privacy Rights Act, or CPRA, was passed by voters in California as part of the November 3, 2020 election. The CPRA is expected to modify the CCPA, potentially resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply. The enactment of the CCPA is prompting a wave of similar legislative developments in other states in the United States, which could create the potential for a patchwork of overlapping but different state laws. Other privacy legislation has been proposed at the federal and state levels, which, if enacted, could increase our potential liability, increase our compliance costs and adversely affect our business.

Compliance with data protection laws and regulations could require us to take on more onerous obligations in our contracts, increase our costs of legal compliance, restrict our ability to collect, use and disclose personal data, or in some cases, impact our or our partners’ or suppliers’ ability to operate in certain jurisdictions. Failure to comply with these laws and regulations could result in government investigations and/or enforcement actions (which could include civil, criminal and administrative penalties), private litigation and/or adverse publicity and could negatively affect our operating results and business. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.

With new and proposed laws and regulations imposing new and relatively burdensome obligations, and with substantial uncertainty over the interpretation and application of these and other laws and regulations, we may face challenges in addressing their requirements and making necessary changes to our policies and practices, and may incur significant costs and expenses in an effort to do so. Although we endeavor to comply with our published policies, certifications, and documentation, we may at times fail to do so or may be perceived to have failed to do so. Moreover, despite our efforts, we may not be successful in achieving compliance if our employees or vendors to comply with our published policies and documentation. Any failure or perceived failure by us to comply with our privacy policies, our privacy-, data protection-, or information security-related obligations to customers or other third parties or any of our other legal obligations relating to privacy, data protection, or information security may result in governmental investigations or enforcement actions, litigation, claims, or public statements against us by consumer advocacy groups or others, and could result in significant liability or cause our customers to lose trust in us, which could have an adverse effect on our reputation and business. Furthermore, the costs of compliance with, and other burdens imposed by, the laws, regulations, and policies that are applicable to the businesses of our customers may limit the adoption and use of, and reduce the overall demand for, our services.

Additionally, if third parties we work with violate applicable laws or regulations or our policies, such violations may also put our data at risk and could in turn have an adverse effect on our business. Any significant change to applicable laws, regulations or industry practices regarding the collection, use, retention, security, or disclosure of data, or regarding the manner in which the express or implied consent for the collection, use, retention, or disclosure of such data is obtained, could increase our costs and require us to modify our operations, possibly in a material manner, which we may be unable to complete and may limit our ability to store and process customer data and operate our business.

Clinical research is heavily regulated and failure to comply with human subject protection regulations may disrupt our research program leading to significant expense, regulatory enforcement, private lawsuits and reputational damage.

Clinical research is subject to federal, state and, for studies conducted outside of the United States, international regulation. At the federal level, the FDA and Department of Health and Human Services impose requirements for the protection of human subjects in clinical research, including requirements such as initial and ongoing institutional review board review, informed consent requirements and other protections to minimize the risk and maximize the benefit to research participants. Many states impose human subject protection laws that

 

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mirror or in some cases exceed federal requirements. HIPAA and other health information laws also impose restrictions on the use and disclosure of PHI in connection with research activities. Research conducted overseas is subject to a variety of national protections such as mandatory ethics committee review, as well as laws regulating the use, disclosure and cross-border transfer of personal data. The costs of compliance with these laws may be significant and compliance with regulatory requirements may result in delay. Noncompliance may disrupt our research and result in data that is unacceptable to regulatory authorities, data lock or other sanctions that may significantly disrupt our operations.

Violation of a state’s prohibition on the corporate practice of medicine could result in a material adverse effect on our business.

A number of states, including California, do not allow business corporations to employ physicians to provide professional services. This prohibition against the “corporate practice of medicine” is aimed at preventing corporations such as us from exercising control over the medical judgments or decisions of physicians, such as the pathologists who we rely on for certain services. The state licensure statutes and regulations and agency and court decisions that enumerate the specific corporate practice rules vary considerably from state to state and are enforced by both the courts and regulatory authorities, each with broad discretion. If regulatory authorities or other parties in any jurisdiction successfully assert that we are engaged in the unauthorized corporate practice of medicine, we could be required to restructure our contractual and other arrangements. In addition, violation of these laws may result in sanctions imposed against us and/or our employed professionals through licensure proceedings, and we could be subject to significant administrative, civil and criminal penalties that could result in exclusion from state and federal healthcare programs and/or the need to restructure our operations.

If the validity of an informed consent from a patient enrolled in a clinical trial with one of our partners was challenged, we could be forced to stop using some of our resources, which would hinder our product development efforts.

We have implemented measures to ensure that all clinical data and genetic and other biological samples that we receive from clinical trials conducted by our partners have been collected from subjects who have provided appropriate informed consent for purposes which extend to our product development activities. We seek to ensure these data and samples are provided to us on a subject de-identified manner. We also have measures in place to ensure that the subjects from whom the data and samples are collected do not retain or have conferred on them any proprietary or commercial rights to the data or any discoveries derived from them. Any findings against us, or our partners, could deny us access to or force us to stop using some of our clinical samples and prevent us from relying on or using any related patient data, which would hinder our product development efforts. We could become involved in legal challenges, which could consume our management and financial resources and have an adverse effect on our business.

Ethical, legal and social concerns related to the use of genomic information could reduce demand for our genomic tests.

Genomic testing, like our Decipher tests, has raised ethical, legal, and social issues regarding privacy and the appropriate uses of the resulting information. Governmental authorities could, for social or other purposes, limit or regulate the use of genomic information or genomic testing or prohibit testing for genetic predisposition to certain conditions. Similarly, these concerns may lead patients to refuse to use genomic tests even if permissible.

Ethical and social concerns may also influence U.S. and foreign patent offices and courts with regard to patent protection for technology relevant to our business. These and other ethical, legal and social concerns may limit market acceptance of our products or reduce the potential markets for our products, either of which could have an adverse effect on our business, financial condition or results of operations.

 

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Our employees, independent contractors, consultants, strategic partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and misuse of proprietary information.

We are exposed to the risk that employees, independent contractors, consultants, commercial partners and vendors may engage in fraudulent or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent failures to: (1) comply with government regulations that are applicable to us; (2) comply with clinical laboratory standards we have established; (3) comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or (4) report financial information or data accurately, or disclose unauthorized activities to us. These laws and regulations may impact, among other things, our current as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent misconduct, including fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. It is not always possible to identify and deter employee and other third-party misconduct. The precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any actions are instituted against us under these laws or regulations, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal and state healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Intellectual Property Risks Related to Our Business

If we are unable to obtain and maintain sufficient patent rights for our products or services, we may not be able to compete effectively in our markets.

We rely upon a combination of patents, trade secret protection, and confidentiality agreements to protect the intellectual property related to our technologies, products and services. Our success depends in part on our ability to obtain and maintain patent and other intellectual property protection in the United States and in other countries with respect to our proprietary technology and products.

We have sought to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and products that are important to our business. This process is expensive and time consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.

The patent position of diagnostic companies can be uncertain and involves complex legal and factual questions for which legal principles remain unsolved. The patent applications that we own or in-license may fail to result in issued patents with claims that cover our products or services in the United States or in other foreign countries.

The patent prosecution process is also expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such

 

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output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. We may also rely on trade secrets to protect our technology, especially where we do not believe patent protection is appropriate or feasible. However, trade secrets are difficult to protect. Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our information to competitors. Enforcing a claim that a third party illegally obtained and is using any of our trade secrets is expensive and time consuming, and the outcome is unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how.

There is no assurance that all potentially relevant prior art relating to our patents and patent applications has been found, which can invalidate a patent or prevent a patent from issuing from a pending patent application. Even if patents do successfully issue, and even if such patents cover our products and services, third parties may challenge their validity, enforceability, or scope, which may result in such patents being narrowed, found unenforceable or invalidated. Furthermore, even if they are unchallenged, our patents and patent applications may not adequately protect our intellectual property, provide exclusivity for our products and services, or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competition from third parties, which may have an adverse impact on our business.

Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the patents, covering technology that we license from or license to third parties and are reliant on our licensors, licensees or partners. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. If our current or future licensors, licensees or partners fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If our licensors, licensees or partners are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. Further, although we enter into confidentiality agreements with parties who have access to patentable aspects of our research and development programs, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations, contract manufacturers, consultants, independent contractors, advisors and other third parties, any of these parties may breach these agreements and disclose such results before a patent application is filed, thereby jeopardizing our ability to seek patent protection on technology relating to our research programs.

We, independently or together with our licensors, have filed several patent applications covering various aspects of our products and services. We cannot offer any assurances about which, if any, patents will issue, the breadth of any such patent or whether any issued patents will be found invalid and unenforceable or will be threatened by third parties. Any successful challenge to these patents or any other patents owned by or licensed to us after patent issuance could deprive us of rights necessary for the successful commercialization of any products and services that we may offer. Further, if we encounter delays in regulatory approvals, the period of time during which we could market a product or service under patent protection could be reduced.

Keeping patents and patent applications in force requires the payment of periodic maintenance fees, renewal fees, annuity fees and various other government fees to the USPTO and foreign counterparts over the lifetime of the patents and patent applications. Failure to timely pay these fees or comply with other requirements by us, our licensees or our licensors can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction, which could have a material adverse effect on our business, prospects, financial condition and results of operations.

Patent policy and rule changes could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States. Publications of discoveries in the

 

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scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. We therefore cannot be certain that we or our licensors were the first to make the invention claimed in our owned and licensed patents or pending applications, or that we or our licensor were the first to file for patent protection of such inventions. Under the Leahy-Smith America Invents Act, or the AIA, as of March 16, 2013 the United States moved from a “first to invent” system to a “first to file” system. The AIA also includes a number of significant changes that affect the way patent applications are prosecuted and patent litigation, including the ability of any third-party to challenge the validity of our patents through and inter partes review procedure. In general, the AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

If we are unable to maintain effective proprietary rights for our products or services, we may not be able to compete effectively in our markets.

In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our products and services that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors, and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.

Although all of our employees and consultants enter into invention assignment agreements with us in the ordinary course of business, and any third parties who have access to our proprietary know-how, information, or technology also enter into confidentiality agreements with us in the ordinary course of business, we cannot provide any assurances that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of our trade secrets could impair our competitive position and may have a material adverse effect on our business. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret.

Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. Moreover, third parties may still obtain this information or may come upon this or similar information independently, and we would have no right to prevent them from using that technology or information to compete with us. Trade secrets will over time be disseminated within the industry through independent development, the publication of journal articles and the movement of personnel skilled in the art from company to company or academic to industry scientific positions. Though our agreements with third parties typically restrict the ability of our advisors, employees, collaborators, licensors, suppliers, third-party contractors and consultants to publish data potentially relating to our trade secrets, our agreements may contain certain limited publication rights. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. Because from time to time we expect to rely on third parties in the development, manufacture, and distribution of our products and provision of our services, we must, at times, share trade secrets with them. Despite employing the contractual and other security precautions described above, the need to share trade secrets increases the risk that such trade

 

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secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information may be greatly reduced and our competitive position would be harmed. If we do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There have been many lawsuits and other proceedings involving patent and other intellectual property rights in the biotechnology industry, including patent infringement lawsuits, interferences, oppositions, and reexamination proceedings before the U.S. Patent and Trademark Office, or the USPTO, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing products and services. As the biotechnology industry expands and more patents are issued, the risk increases that our products and services may be subject to claims of infringement of the patent rights of third parties.

Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture, or methods for treatment related to the use or manufacture of our products and services. We have conducted analyses of third-party rights with respect to only certain of our products and services, and therefore we do not know whether there are any third-party patents that would impair our ability to commercialize these products and services. We also cannot guarantee that any of our analyses are complete and thorough, nor can we be sure that we have identified each and every patent and pending application in the United States and abroad that is relevant or necessary to the commercialization of our products and services. Because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that our products or services may infringe.

In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover aspects of our products or services, the holders of any such patents may be able to block our ability to commercialize such products or services unless we obtained a license under the applicable patents, or until such patents expire or are finally determined to be invalid or unenforceable. Such a license may not be available on commercially reasonable terms or at all.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our products or services. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

We may not be successful in obtaining or maintaining necessary rights to our products or services through acquisitions and in-licenses.

We currently have rights to the intellectual property, through licenses from third parties and under patents that we own, to develop our products and services. Because our programs may require the use of proprietary rights held by third parties, the growth of our business will likely depend in part on our ability to acquire, in-license, or use these proprietary rights. We may be unable to acquire or in-license any compositions, methods

 

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of use, processes, or other third-party intellectual property rights from third parties that we identify as necessary for our products or services. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies are also pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, cash resources, and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment.

We sometimes collaborate with U.S. and foreign institutions to accelerate our research or development under written agreements, including license agreements, with these institutions. For example, we are currently party to license agreements with Mayo Foundation for Medical Education and Research, University of Michigan and University of British Columbia. Our rights to use the licensed intellectual property from these and other counterparties and to employ the inventions claimed in patents covered by these licenses are subject to the continuation of, and our compliance with, the terms of the applicable licenses. We are obligated under these licenses to, among other things, pay certain royalties in connection with commercial sales of the licensed products. The term of these licenses generally ends concurrently with the end of our royalty obligations to the applicable counterparty, but in certain circumstances the licenses may be terminated earlier. Termination of any of these licenses could prevent us from producing or selling some or all of our products, and a failure of the licensors to abide by the terms of the licenses or to prevent infringement by third parties could harm our business and negatively impact our market position. Failure of a licensor to abide by the terms of a license or to prevent infringement by third parties could also harm our business and negatively impact our market position.

If we are unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights we have, we may have to abandon development of that program and our business and financial condition could suffer.

Although we are not currently involved in any litigation, we may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.

Competitors may infringe our patents or the patents of our licensors. Although we are not currently involved in any litigation, if we or one of our licensing partners were to initiate legal proceedings against a third-party to enforce a patent covering one of our products or services, the defendant could counterclaim that the patent covering our product or service is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of patentable subject matter, lack of novelty, obviousness, or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable.

The AIA brought a number of changes to the U.S. patent system, including many new rules and ramifications for patent holders. Among the most significant were the changes to post-grant proceedings, which are the formal processes offered by the USPTO to challenge a competitor’s patent, or strengthen a patent already granted to a company. These proceedings include:

 

   

Post-grant review, which is a trial-like proceeding at the Patent Trial and Appeal Board to review the patentability of claims on any grounds that can be raised under 35 U.S.C. § 282(b)(2) or (3). The post-grant review became effective on September 16, 2012. With the exception of “covered business method patents,” the post-grant review procedure generally applies to patents subject to the AIA’s first-inventor-to-file provisions, i.e., patents issuing from applications having an effective filing date after March 16, 2013.

 

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Inter partes review, which replaced the inter partes reexamination option, is a trial-like proceeding to review the patentability of claims, but using only prior art consisting of patents or printed publications. It can be used as an alternative to litigating patent validity in federal District Court. The inter partes review procedure took effect on September 16, 2012, and applies to any patent issued before, on, or after that date.

 

   

Ex parte reexamination, which remained substantially intact after passage of the AIA. An ex parte reexamination can be requested by the patent holder or another party, but the review process itself involves only the USPTO and the patentee. Ex parte reexamination continues to be conducted before a patent examiner, and not the Patent Trial and Appeal Board. The review of a patent is based solely on patents and printed publications.

The AIA and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation or adversarial proceedings before the USPTO. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.

Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties.

Because of the expense and uncertainty of litigation, we may conclude that even if a third party is infringing our issued patent, any patents that may be issued as a result of our pending or future patent applications or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of our company or our stockholders. In such cases, we may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution.

We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

We employ certain individuals who were previously employed at universities or other biotechnology, pharmaceutical companies, diagnostic and life sciences companies including our competitors or potential competitors. Although we try to ensure that our employees, consultants, and independent contractors do not use the proprietary information or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants, or independent contractors have wrongfully used or disclosed

 

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confidential information of third parties, we may in the future be subject to such claims. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

Although we are not currently subject to any claims challenging the inventorship of our patents or ownership of our intellectual property, we may in the future be subject to claims that former employees, collaborators or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involved in developing our products or services. Litigation may be necessary to defend against these and other claims challenging inventorship. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Developments or uncertainty in patent statutes, patent case law or patent office rules and regulations may impact the validity of our patent rights.

Our patent rights may be affected by developments or uncertainty related to the patent statutes, patent case law or patent office rules and regulations in the United States or other jurisdictions. The patent position of companies engaged in the development and commercialization of diagnostic tests are particularly uncertain. In the recent past, three patent disputes have been decided by the United States Supreme Court involving diagnostic method claims, “gene patents,” and diagnostic analytical tools. On March 20, 2012, the Supreme Court issued a decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., a case involving patent claims directed to measuring a metabolic product in a patient to optimize a drug dosage amount for the patient. According to the Supreme Court, the addition of well-understood, routine or conventional activity such as “administering” or “determining” steps was not enough to transform an otherwise patent ineligible natural phenomenon into patent eligible subject matter. On June 13, 2013, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., a case involving patent claims held by Myriad Genetics, Inc. relating to the breast cancer susceptibility genes BRCA1 and BRCA2. The Court held that isolated segments of naturally occurring DNA, such as the DNA constituting the BRCA1 and BRCA2 genes, is not patent eligible subject matter, but that complementary DNA, which is a construct that may be created from RNA transcripts of genes, may be patent eligible. On June 19, 2014, the Supreme Court issued its decision in Alice Corp. v. CLS Bank Int’l, a case involving the patent eligibility of computer-implemented method claims. In Alice, the Supreme Court held that implementation of an otherwise abstract idea on a computer was not enough by itself to make the idea patent-eligible. What remains unclear after Alice is how an abstract idea is defined, which the Court explicitly declined to address. Since the Alice decision, although the courts have issued numerous decisions regarding the subject matter eligibility test, there remains a great deal of uncertainty as to the eligibility of patents involving diagnostic methods and software-based tools, such as proprietary analytical algorithms. In addition, although the USPTO has issued guidance and examples of eligible and ineligible subject matter that can inform decision-making at the USPTO, federal courts are not bound by this guidance.

We cannot assure you that our efforts to seek patent protection for our technology and products will not be negatively impacted by the decisions described above, rulings in other cases or changes in guidance or procedures issued by the USPTO. We cannot predict what impact the Supreme Court’s decisions in Prometheus, Myriad, and Alice may have on the ability of diagnostic companies or other entities to obtain or enforce patents relating to diagnostic methods, tools, or isolated products of nature in the future. The patent- eligibility of diagnostic methods and algorithmic analysis techniques are particularly in flux.

 

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Moreover, although the Supreme Court has held in Myriad that isolated segments of naturally-occurring DNA are not patent-eligible subject matter, certain third parties could allege that activities that we may undertake infringe other gene-related patent claims, and we may deem it necessary to defend ourselves against these claims by asserting non-infringement and/or invalidity positions, or pay to obtain a license to these patents. In any of the foregoing or in other situations involving third-party intellectual property rights, if we are unsuccessful in defending against claims of patent infringement, we could be forced to pay damages and ongoing royalties, and to obtain licenses from third parties, or be subjected to an injunction that would prevent us from utilizing the patented subject matter. We may not be able to obtain these licenses on acceptable terms, if at all. Such outcomes could materially affect our ability to offer our tests and harm our business.

The full impact of these decisions is not yet known and they have created uncertainty around the patent- eligibility of diagnostic tests and methods. The claims of our patent applications may therefore fail to issue, or if they do issue, may subsequently be challenged or invalidated, on the grounds that they include subject matter that is not patent-eligible based on the Supreme Court’s rulings in these cases and the further evolution of case law in this area.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents on products and services in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products or information made or obtained using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and may also export infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology products, which could make it difficult for us to stop the infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products.

Any future collaborations that we enter into may not be successful. The success of our collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that:

 

   

collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations;

 

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collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;

 

   

collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates;

 

   

a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;

 

   

we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;

 

   

collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability;

 

   

disputes may arise between us and a collaborator that causes the delay or termination of the research, development or commercialization of our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;

 

   

collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products;

 

   

collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; and

 

   

a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings.

Our collaborators may assert ownership or commercial rights to inventions we develop from our use of the biological materials which they provide to us, or otherwise arising from the collaboration.

We collaborate with several institutions, physicians and researchers in scientific matters. Also, we rely on numerous third parties to provide us with tissue samples that we use to develop tests. If we cannot successfully negotiate sufficient ownership and commercial rights to any inventions that result from our use of a third-party collaborator’s materials, or if disputes arise with respect to the intellectual property developed with the use of a collaborator’s samples, or data developed in a collaborator’s study, we may be limited in our ability to capitalize on the market potential of these inventions or developments.

If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

Our current or future trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. We may license our trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how our

 

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trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names. Our efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our financial condition or results of operations.

Risks Relating to Our Financial Condition and Capital Requirements

Even if this offering is successful, we may need to raise additional capital and if we are unable to do so when needed or on acceptable terms, we may be forced to delay, limit or terminate our product development and commercialization efforts or other operating plans.

To date, we have funded our operations primarily through equity and debt financings and to a lesser extent through revenue generated from the sale of Decipher genomic tests. Based on our current business plan, we believe that the net proceeds from this offering, together with our existing cash and cash equivalents and our anticipated cash flows generated from sales of our products, will be sufficient to meet our anticipated cash required over at least the next        months from the date of this prospectus. We may need to raise capital in the future as and to the extent we:

 

   

attract, hire and retain qualified personnel;

 

   

continue to innovate and develop additional products, expand Decipher GRID and conduct our ongoing and new clinical trials to generate the evidence required to support expanded reimbursement of our products;

 

   

expand our sales territories with our expanded product portfolio, increase our presence, and increase our marketing activities to drive further awareness and adoption of our products;

 

   

protect and defend our intellectual property;

 

   

invest in processes, infrastructure and personnel to support the growth of our business; and

 

   

operate as a public company.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our genomic tests. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than would otherwise be ideal and we may be required to relinquish rights to some of our technologies or genomic tests, or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of one or more products or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially adversely affect our business, financial condition and results of operations.

Raising additional funds through debt or equity financing could be dilutive and may cause the market price of our common stock to decline.

To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of those securities could result in substantial dilution for our current stockholders and the terms may include liquidation or other preferences that adversely affect the rights of our current stockholders. Furthermore, the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause

 

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the market price of our common stock to decline and existing stockholders may not agree with our financing plans or the terms of such financings. Moreover, the incurrence of debt financing could result in a substantial portion of our operating cash flow being dedicated to the payment of principal and interest on such indebtedness and could impose restrictions on our operations, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additional funding may not be available to us on acceptable terms, or at all.

Payments under our loan agreement will reduce our cash and cash equivalents available to fund our operations. In addition, a default under our loan agreement could cause a material adverse effect on our financial position.

In September 2015, we entered into a term loan agreement, as amended from time to time, or the Loan Agreement, with CRG Servicing LLC and certain of its affiliates, which we collectively refer to as CRG. Under the terms of the Loan Agreement, we have borrowed term loans in an aggregate principal amount of $32.0 million. The loan, which is secured by a lien covering substantially all of our assets, excluding certain assets held by Decipher Corp., our wholly owned Delaware subsidiary, requires us to make quarterly payments of accrued interest. As long as we are not in default under the Loan Agreement, we may defer up to 5.0% per annum of the interest payment, or PIK Interest, which is added to the principal balance. Upon maturity or the date the loan becomes due and payable for any other reason, we will be responsible for making a 12.0% back-end payment on the aggregate principal amount of the term loan (excluding PIK Interest). Payments under the loan could result in a significant reduction of our cash and cash equivalents.

We are required to satisfy certain reporting covenants and to comply with certain affirmative and restrictive covenants, including covenants regarding delivery of financial statements, notice of material events, maintenance of property, payment of taxes, maintenance of insurance, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness and transactions with affiliates, among other customary covenants under the Loan Agreement. In addition, we are subject to financial covenants, including a minimum annual revenue covenant. Pursuant to this covenant, we are required to have revenue of $30.0 million in 2020 and $36.0 million in 2021 and each annual period thereafter during the term of the Loan Agreement. Upon the occurrence of certain events of default, including but not limited to the failure by us to satisfy our payment obligations under the Loan Agreement, the failure by us to satisfy minimum annual revenue covenant, and the breach of certain of our other covenants under the Loan Agreement, CRG could proceed against the collateral granted to it to secure our indebtedness and/or declare all obligations under the Loan Agreement to be due and payable, including a prepayment premium of up to 5% of the aggregate outstanding principal amount being repaid, if such declaration is made prior to maturity. In certain circumstances, procedures by CRG could result in a loss by us of all of our equipment and inventory, which are included in the collateral granted to CRG. If any indebtedness under the Loan Agreement were to be accelerated, there can be no assurance that our assets would be sufficient to repay in full that indebtedness. In addition, upon any distribution of assets pursuant to any liquidation, insolvency, dissolution, reorganization or similar proceeding, the holders of secured indebtedness will be entitled to receive payment in full from the proceeds of the collateral securing our secured indebtedness before the holders of other indebtedness or our common stock will be entitled to receive any distribution with respect thereto.

If we enter into additional debt or credit financing arrangements with the consent of our existing lenders, the terms of such additional debt or credit arrangements could further restrict our operating and financial flexibility. In the event we must cease operations and liquidate our assets, the rights of our existing lenders and any other holder of our outstanding debt would be senior to the rights of the holders of our common stock to receive any proceeds from the liquidation.

 

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Changes in financial accounting standards or practices may cause adverse, unexpected financial reporting fluctuations and affect our reported operating results.

U.S. generally accepted accounting principles, or GAAP, is subject to interpretation by the Financial Accounting Standards Board, the Securities and Exchange Commission, or the SEC, and various bodies formed to promulgate and interpret appropriate accounting principles. A change in accounting standards or practices can have a significant effect on our reported results and may even affect our reporting of transactions completed before the change is effective. For example, as described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Revenue Recognition” and in Note 1 to our consolidated financial statements, we recently adopted the revenue recognition standard under ASC 606 which superseded previous revenue recognition guidance applicable to us. New accounting pronouncements and varying interpretations of accounting pronouncements have occurred and may occur in the future. Changes to existing rules or the questioning of current practices may adversely affect our reported financial results or the way we conduct our business.

Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.

The TCJA enacted many significant changes to the U.S. tax laws. Future guidance from the IRS and other tax authorities with respect to the TCJA may affect us, and certain aspects of the TCJA could be repealed or modified in future legislation. For example, the CARES Act modified certain provisions of the TCJA. Changes in corporate tax rates, the realization of net deferred tax assets relating to our U.S. operations, the taxation of foreign earnings and the deductibility of expenses under the TCJA or future tax reform legislation could have a material impact on the value of our deferred tax assets, could result in significant one-time charges in the current or future taxable years and could increase our future U.S. tax expense. The foregoing items, as well as any other future changes in tax laws, could have a material adverse effect on our business, cash flow, financial condition or results of operations. In addition, it is uncertain if and to what extent various states will conform to the TCJA, the CARES Act, or any newly enacted federal tax legislation.

Our ability to use net operating losses to offset future taxable income may be subject to limitations.

As of December 31, 2019, we had U.S. federal, state and Canadian net operating loss, or NOL, carryforwards of approximately $44.2 million, $34.5 million and $72.7 million, respectively. Utilization of these NOLs depends on many factors, including our future income, which cannot be assured. Under the TCJA, as modified by the CARES Act, U.S. federal NOLs incurred in taxable years beginning after December 31, 2017, may be carried forward indefinitely, but our ability to utilize such U.S. federal NOLs to offset taxable income in taxable years beginning after December 31, 2020, is limited to 80% of the current-year taxable income. It is uncertain if and to what extent various U.S. states will conform to the TCJA or the CARES Act. In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, and corresponding provisions of U.S. state law, if a corporation undergoes an “ownership change” (which is generally defined as a greater than 50 percentage point change (by value) in its equity ownership over a rolling three-year period), the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. We have not determined whether we have experienced Section 382 ownership changes in the past and if a portion of our NOLs is therefore subject to an annual limitation under Section 382. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed. For example, California imposed limits on the usability of California state NOLs to offset California taxable income in tax years beginning after 2019 and before 2023. We may experience ownership changes as a result of subsequent changes in our stock ownership, including this offering, some of which may be outside of our control. In addition, under the rules of the Canadian Income Tax Act, utilization of our Canadian NOL carryforwards may be subject to limitation if we are considered to not have business continuity, among other tests, in the future taxation year when the Canadian NOL carryforwards are applied. We have not yet performed an analysis to determine how

 

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much, if any, of our Canadian NOL carryforwards would be available to be utilized in the future. If our ability to use our NOL carryforwards is materially limited, it would harm our future operating results by effectively increasing our future tax obligations.

Risks Relating to this Offering and Ownership of our Common Stock

We do not know whether an active, liquid and orderly trading market will develop for our common stock or what the market price of our common stock will be and as a result it may be difficult for you to sell your common stock.

Prior to this offering there has been no public market for our common stock. Although we have applied to list our common stock on the Nasdaq Global Market, or Nasdaq, an active trading market for our shares may never develop or be sustained following this offering. You may not be able to sell your shares quickly or at the market price if trading in our common stock is not active. The initial public offering price for our common stock was determined through negotiations with the underwriters, and the negotiated price may not be indicative of the market price of the common stock after the offering. As a result of these and other factors, you may be unable to resell your common stock at or above the initial public offering price. Further, an inactive market may also impair our ability to raise capital by selling our common stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using our common stock as consideration.

We expect that the trading price of our common stock will fluctuate significantly, and investors may not be able to resell their shares at or above the initial public offering price.

The trading price of our common stock following this offering may be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control. As a result of this volatility, you may not be able to sell your common stock at or above the initial public offering price, if at all. The market price for our common stock may be influenced by many factors, including:

 

   

progress, or lack of progress, in developing and commercializing our current genomic tests and our planned future genomic tests;

 

   

favorable or unfavorable decisions about our tests from government regulators, insurance companies and other payors;

 

   

our ability to recruit and retain qualified research and development personnel;

 

   

changes in investors’ and securities analysts’ perception of the business risks and conditions of our business;

 

   

changes in our relationship with key collaborators;

 

   

changes in the market valuation or earnings of our competitors or companies viewed as similar to us;

 

   

changes in key personnel;

 

   

depth of the trading market in our common stock;

 

   

termination of the lock-up agreements or other restrictions on the ability of our existing stockholders to sell shares after this offering;

 

   

changes in our capital structure, such as future issuances of securities or the incurrence of additional debt;

 

   

the granting or exercise of employee stock options or other equity awards;

 

   

realization of any of the risks described under this section titled “Risk Factors”; and

 

   

general market and economic conditions.

 

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In addition, the stock market in general, and Nasdaq and the diagnostics industry in particular, have from time to time experienced volatility that often has been unrelated to the operating performance of the underlying companies. These broad market and industry fluctuations may adversely affect the market price of our common stock, regardless of our operating performance. In several recent situations where the market price of a stock has been volatile, holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our stockholders were to bring a lawsuit against us, the defense and disposition of the lawsuit could be costly and divert the time and attention of our management and harm our operating results.

We do not intend to pay dividends on our common stock so any returns will be limited to the value of our shares of common stock.

We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the Loan Agreement with CRG contains restrictions on our ability to declare and pay cash dividends on our capital stock. Any return to stockholders will therefore be limited to the appreciation of their shares.

Our principal stockholders and management own a significant percentage of our shares and will be able to exert significant control over matters subject to stockholder approval.

Prior to this offering, our executive officers, directors, and 5% or greater stockholders beneficially owned approximately 80.8% of our voting shares as of December 31, 2020, and, upon the closing of this offering, that same group will hold approximately         % of our outstanding voting shares (assuming no exercise of the underwriters’ option to purchase additional shares) in each case based on the initial public offering price of $        per share (the midpoint of the price range set forth on the cover page of this prospectus). The previously discussed ownership percentage upon the closing of this offering does not reflect the potential purchase of any shares in this offering by such persons. Therefore, even after this offering, these stockholders will have the ability to influence us through this ownership position. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest as one of our stockholders.

If you purchase our common stock in this offering, you will incur immediate and substantial dilution in the book value of your shares.

The initial public offering price is substantially higher than the net tangible book value per share of our common stock. Investors purchasing common stock in this offering will pay a price per share that substantially exceeds the book value of our tangible assets after subtracting our liabilities. As a result, investors purchasing common stock in this offering will incur immediate dilution of $        per share, based on the initial public offering price of $        per share. Further, investors purchasing common stock in this offering will contribute approximately         % of the total amount invested by stockholders since our inception, but will own only approximately         % of the common stock outstanding after giving effect to this offering.

This dilution is due to our investors who purchased shares prior to this offering having paid substantially less when they purchased their shares than the price offered to the public in this offering and the exercise of stock options granted to our employees. To the extent outstanding options or warrants are exercised, there will be further dilution to new investors. As a result of the dilution to investors purchasing shares in this offering, investors may receive significantly less than the purchase price paid in this offering, if anything, in the event of our liquidation.

 

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Delaware law and provisions in our amended and restated certificate of incorporation and amended and restated bylaws that will be in effect at the completion of this offering could make a merger, tender offer or proxy contest difficult, thereby depressing the trading price of our common stock.

Provisions of our amended and restated certificate of incorporation and amended and restated bylaws, which will become effective immediately prior to and upon the completion of this offering, respectively, may delay or discourage transactions involving an actual or potential change in our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Among other things, our amended and restated certificate of incorporation and amended and restated bylaws will:

 

   

permit our board of directors to issue up to                 shares of preferred stock, with any rights, preferences and privileges as they may designate (including the right to approve an acquisition or other change in our control);

 

   

provide that the authorized number of directors may be changed only by resolution of the board of directors;

 

   

provide that our board of directors or any individual director may only be removed with cause and the affirmative vote of the holders of at least 66-2/3% of the voting power of all of our then-outstanding common stock;

 

   

provide that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

 

   

divide our board of directors into three classes;

 

   

require that any action to be taken by our stockholders must be effected at a duly called annual or special meeting of stockholders and not be taken by written consent;

 

   

provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner and also specify requirements as to the form and content of a stockholder’s notice;

 

   

do not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of common stock entitled to vote in any election of directors to elect all of the directors standing for election, if they should so choose);

 

   

provide that special meetings of our stockholders may be called only by the chair of our board of directors, our Chief Executive Officer or by the board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors; and

 

   

provide that the Court of Chancery of the State of Delaware (or, if and only if the Court of Chancery of the State of Delaware lacks subject matter jurisdiction, any state court located within the State of Delaware or, if and only if all such state courts lack subject matter jurisdiction, the federal district court for the District of Delaware) and any appellate court therefrom will be the sole and exclusive forum for the following types of actions or proceedings under Delaware statutory or common law: (i) any derivative action or proceeding brought on our behalf; (ii) any action or proceeding asserting a claim of breach of a fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders; (iii) any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees, arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws; (iv) any action or proceeding to interpret, apply, enforce or determine the validity of our certificate of incorporation or our bylaws; (v) any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; and (vi) any action asserting a claim

 

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against us or any of our current or former directors, officers or other employees governed by the internal affairs doctrine or otherwise related to our internal affairs, in all cases to the fullest extent permitted by law and subject to the court’s having personal jurisdiction over the indispensable parties named as defendants; provided, that, this Delaware forum provision set forth in our amended and restated certificate of incorporation and amended and restated bylaws will not apply to suits brought to enforce a duty or liability created by the Securities Act or the Exchange Act, or any other claim for which the federal courts have exclusive jurisdiction.

Further, our amended and restated certificate of incorporation provides that unless we consent in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district courts of the United States will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act.

The amendment of any of these provisions, with the exception of the ability of our board of directors to issue shares of preferred stock and designate any rights, preferences and privileges thereto, would require approval by the holders of at least 66-2/3% of our then-outstanding common stock.

In addition, as a Delaware corporation, we are subject to Section 203 of the Delaware General Corporation Law. These provisions may prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from merging or combining with us for a certain period of time. A Delaware corporation may opt out of this provision by express provision in its original certificate of incorporation or by amendment to its certificate of incorporation or bylaws approved by its stockholders. However, we have not opted out of this provision.

These and other provisions in our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law could make it more difficult for stockholders or potential acquirors to obtain control of our board of directors or initiate actions that are opposed by our then-current board of directors, including delay or impede a merger, tender offer or proxy contest involving our company. The existence of these provisions could negatively affect the price of our common stock and limit opportunities for you to realize value in a corporate transaction.

Our amended and restated certificate of incorporation and amended and restated bylaws that will become effective upon the closing of this offering provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

Our amended and restated certificate of incorporation and amended and restated bylaws that will become effective upon the closing of this offering provide that the Court of Chancery of the State of Delaware is the exclusive forum for the following types of actions or proceedings under Delaware statutory or common law:

 

   

any derivative action or proceeding brought on our behalf;

 

   

any action or proceeding asserting a breach of fiduciary duty owed by any of our current or former directors, officers or other employees to us or our stockholders;

 

   

any action or proceeding asserting a claim against us or any of our current or former directors, officers or other employees arising out of or pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or bylaws;

 

   

any action or proceeding to interpret, apply, enforce or determine the validity of our amended and restated certificate of incorporation or our amended and restated bylaws;

 

   

any action or proceeding as to which the Delaware General Corporation Law confers jurisdiction to the Court of Chancery of the State of Delaware; and

 

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any action asserting a claim against us or any of our directors, officers or other employees that is governed by the internal affairs doctrine or otherwise related to our internal affairs.

This provision would not apply to suits brought to enforce a duty or liability created by the Securities Act or the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. Furthermore, Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, our amended and restated certificate of incorporation and amended and restated bylaws further provide that the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act. While the Delaware courts have determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity and enforceability of the exclusive forum provisions of our amended and restated certificate of incorporation and amended and restated bylaws. This may require significant additional costs associated with resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.

These exclusive forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers, or other employees, which may discourage lawsuits against us and our directors, officers and other employees. If a court were to find either exclusive-forum provision in our amended and restated certificate of incorporation and amended and restated bylaws to be inapplicable or unenforceable in an action, we may incur further significant additional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.

We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act, and may remain an emerging growth company for up to five full fiscal years following this offering. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:

 

   

being permitted to provide only two years of audited financial statements in this prospectus, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure;

 

   

not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;

 

   

not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;

 

   

reduced disclosure obligations regarding executive compensation; and

 

   

exemptions from the requirements of holding a non-binding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

We have taken advantage of reduced reporting burdens in this prospectus. In particular, in this prospectus, we have provided only two years of audited financial statements and correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure and have not included all of the executive compensation related information that would be required if we were not an emerging growth company. We cannot predict whether investors will find our common stock less attractive if we rely on these

 

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exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile. In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies. We have elected to use this extended transition period until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.

We previously identified a material weakness in our internal control over financial reporting. If our internal control over financial reporting is not effective, we may not be able to accurately report our financial results or file our future periodic reports in a timely manner, which may cause adverse effects on our business and may cause investors to lose confidence in our reported financial information and may lead to a decline in our stock price.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports in a timely manner. In connection with the audit of our financial statements for the year ended December 31, 2018, we concluded there was a material weakness in our internal control over financial reporting. However, as of December 31, 2019, we concluded that the material weakness had been remediated. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis.

The material weakness in 2018 related to a lack of (i) personnel with appropriate knowledge, experience and training commensurate with accounting and reporting requirements and (ii) appropriately designed and implemented controls to evaluate redeemable convertible preferred stock, and resulted in certain material corrections to the financial statements. To remediate the material weakness, we implemented measures designed to improve our internal control over financial reporting, including retaining SEC compliance and technical accounting consultants.

If we are unable to successfully identify any future significant deficiencies or material weaknesses, the accuracy and timing of our financial reporting may be adversely affected, a material misstatement in our financial statements could occur, we may be unable to maintain compliance with securities law requirements regarding timely filing of periodic reports, which may adversely affect our business and our stock price may decline as a result.

In addition, following the completion of this offering, we will be required to expend significant time and resources to further improve our internal control over financial reporting, including by further expanding our finance and accounting staff to meet the demands that will be placed upon us as a public company, including the requirements of the Sarbanes-Oxley Act. If we fail to adequately staff our accounting and finance function or fail to maintain adequate internal control over financial reporting, any new or recurring material weaknesses could prevent our management from concluding our internal control over financial reporting is effective and impair our ability to prevent material misstatements in our financial statements, which could cause our business to suffer.

We will incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives and corporate governance practices.

As a public company, and particularly after we are no longer an emerging growth company, we will incur significant legal, accounting and other expenses that we did not incur as a private company. The Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of the Nasdaq and other applicable securities rules and regulations impose various requirements on public companies, including

 

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establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified members of our board of directors.

We are evaluating these rules and regulations, and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Pursuant to Section 404 of the Sarbanes-Oxley Act, or Section 404, we will be required to furnish a report by our management on our internal control over financial reporting. However, while we remain an emerging growth company, we will not be required to include an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we will be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, potentially engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting. Despite our efforts, there is a risk that we will not be able to conclude, within the prescribed timeframe or at all, that our internal control over financial reporting is effective as required by Section 404. If we identify one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

Sales of a substantial number of our common stock by our existing stockholders in the public market could cause our share price to fall.

If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after the lock-up and other legal restrictions on resale discussed in this prospectus lapse, the trading price of our common stock could decline. Based on common stock outstanding as of September 30, 2020, upon the closing of this offering we will have outstanding a total of                shares of common stock. Of these shares, only the common stock sold in this offering by us, plus any shares sold upon exercise of the underwriters’ option to purchase additional shares, will be freely tradable without restriction in the public market immediately following this offering. Evercore Group L.L.C. and Wells Fargo Securities, LLC, however, may, in their sole discretion, permit our officers, directors and other securityholders who are subject to these lock-up agreements to sell shares prior to the expiration of the lock-up agreements.

We expect that the lock-up agreements pertaining to this offering will expire 180 days from the date of this prospectus. In addition, common stock that are either subject to outstanding options or reserved for future issuance under our employee benefit plans will become eligible for sale in the public market to the extent permitted by the provisions of various vesting schedules, the lock-up agreements and Rule 144 and Rule 701 under the Securities Act. If these additional common stock are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

After this offering, the holders of                  shares of common stock as of September 30, 2020 will be entitled to rights with respect to the registration of their shares under the Securities Act, subject to the 180-day lock-up agreements described above. See “Description of Capital Stock—Registration Rights.” Registration of

 

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these shares under the Securities Act would result in the shares becoming freely tradable without restriction under the Securities Act, except for shares held by affiliates, as defined in Rule 144 under the Securities Act. Any sales of securities by these stockholders could have a material adverse effect on the trading price of our common stock.

Our unaudited condensed consolidated financial statements contain disclosure regarding the substantial doubt about our ability to continue as a going concern. We will need additional financing to execute our business plan, to fund our operations and to continue as a going concern.

We have prepared cash flow forecasts which indicate that, based on our expected cash flows and timing of the maturity of our long-term debt, there is substantial doubt about our ability to continue as a going concern for the twelve months after the date our unaudited condensed consolidated financial statements for the nine months ended September 30, 2020 were issued. If we are unable to raise sufficient capital when needed, our business, financial condition and results of operations will be materially and adversely affected, and we will need to significantly modify our operational plans to continue as a going concern. If we are unable to continue as a going concern, we might have to liquidate our assets and the values we receive for our assets in liquidation or dissolution could be significantly lower than the values reflected in our consolidated financial statements. The inclusion of a going concern explanatory paragraph by our auditors, our lack of cash resources and our potential inability to continue as a going concern may materially adversely affect our share price and our ability to raise new capital or to enter into critical contractual relations with third parties.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our share price to fall.

We expect that significant additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales.

These sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders.

Pursuant to the 2021 Plan, our management is authorized to grant stock options and other equity-based awards to our employees, directors and consultants. Subject to the terms of the 2021 Plan, our board of directors or the authorized committee thereof, referred to herein as the plan administrator, is also authorized to modify outstanding awards under the 2021 Plan. The plan administrator has the authority to reduce the exercise, purchase or strike price of any outstanding stock award, cancel any outstanding stock award in exchange for new stock awards, cash or other consideration, or take any other action that is treated as a repricing under generally accepted accounting principles, with the consent of any adversely affected participant. Stockholder approval for such repricing is not required. Following this offering,                  shares of our common stock (plus the number of shares (not to exceed                shares) reserved for issuance under the 2018 Plan at the time the 2021 Plan becomes effective and any common stock underlying outstanding share awards that were granted under the Prior Plans that are forfeited, terminate, expire or are otherwise not issued) will be authorized for issuance pursuant to such equity-based awards. The number of shares available for future grant under the 2021 Plan will automatically increase on January 1 of each year by         % of the total number of our common stock outstanding on December 31 of the preceding calendar year, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year. Pursuant to the ESPP, following this offering shares of our common stock will be authorized for issuance pursuant to purchase rights granted to our employees or to employees of any of our designated affiliates. The number of our common stock reserved for issuance under the ESPP will automatically increase on January 1 of each calendar year by the lesser of 1% of the total number of

 

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our common stock outstanding on December 31 of the preceding calendar year and                 shares, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year. Currently, we plan to register the increased number of shares available for issuance under the 2021 Plan and ESPP each year. Increases in the number of shares available for future grant or purchase may result in additional dilution, which could cause the price of our common stock to decline.

We have broad discretion in the use of the net proceeds from this offering and may not use them effectively.

Our management will have broad discretion in the application of the net proceeds from this offering, including for any of the purposes described in the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, their ultimate use may vary substantially from their currently intended use. Our management might not apply our net proceeds in ways that ultimately increase the value of your investment. We expect to use the net proceeds from this offering to continue and expand our product development and commercialization activities and for general corporate purpose. The failure by our management to apply these funds effectively could harm our business.

Pending their use, we may invest the net proceeds from this offering in short-term, investment-grade, interest- bearing securities. These investments may not yield a favorable return to our stockholders. If we do not invest or apply the net proceeds from this offering in ways that enhance stockholder value, we may fail to achieve expected financial results, which could cause our share price to decline.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our share price and trading volume could decline.

The trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts do not currently, and may never, publish research on our company. If no securities or industry analysts commence coverage of our company, the trading price for our shares would likely be negatively impacted. In the event securities or industry analysts initiate coverage, if one or more of the analysts who covers us downgrades our shares or publishes inaccurate or unfavorable research about our business, our share price may decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, demand for our shares could decrease, which might cause our share price and trading volume to decline.

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statements. The forward-looking statements are contained principally in the sections titled “Prospectus Summary,” “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.” These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about:

 

   

our ability to successfully commercialize our current and future products;

 

   

the rate and degree of market acceptance of our genomic tests, including their potential to be integrated as the standard of care;

 

   

our plans and ability to successfully leverage Decipher GRID to expand the depth and breadth of our relationships with pharmaceutical companies and expand our portfolio of innovative products;

 

   

our ability to pursue our business strategy successfully;

 

   

the impact of the COVID-19 pandemic on our business and operations;

 

   

our ability to fund our working capital requirements;

 

   

our ability to obtain and maintain coverage and adequate reimbursement from governmental and other payors for our products;

 

   

our ability to obtain and maintain inclusion of our products in clinical practice guidelines;

 

   

changes in laws or regulations applicable to our business, including potential regulation by the FDA;

 

   

our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;

 

   

our ability to obtain and maintain intellectual property protection for our products and product candidates;

 

   

our ability to expand the indications for our existing genomic tests in prostate cancer and develop and successfully commercialize additional products;

 

   

our ability to retain and recruit key personnel;

 

   

our use of proceeds from this offering;

 

   

our financial performance, including expected financial results for the year ended December 31, 2020; and

 

   

developments and projections relating to our competitors or our industry.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the section titled “Risk Factors” elsewhere in this prospectus. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all

 

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potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this prospectus to conform these statements to new information, actual results or to changes in our expectations, except as required by law.

You should read this prospectus and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, levels of activity, performance, and events and circumstances may be materially different from what we expect.

 

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MARKET AND OTHER INDUSTRY DATA

Unless otherwise indicated, market data and certain industry forecasts used throughout this prospectus were obtained from various sources, including internal surveys, market research, consultant surveys, publicly available information and industry publications and surveys. In some cases, we do not expressly refer to the sources from which this data is derived. Industry surveys, publications, consultant surveys and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. We have not independently verified any of the data from third-party sources nor have we ascertained the underlying assumptions relied upon therein. Similarly, internal surveys, industry forecasts and market research, which we believe to be reliable based upon our management’s knowledge of the industry, have not been independently verified. This information involves a number of assumptions and limitations and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate is necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in above, in the section titled “Risk Factors,” and elsewhere in this prospectus. These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by us.

 

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USE OF PROCEEDS

We estimate that the net proceeds to us from this offering will be approximately $                million (or approximately $                million if the underwriters exercise in full their option to purchase up to                additional shares of common stock), based on an assumed initial public offering price of $                per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

Each $1.00 increase (decrease) in the assumed initial public offering price of $                per share would increase (decrease) the net proceeds to us from this offering by approximately $                million, assuming that the number of shares of common stock offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1.0 million shares of common stock we are offering, would increase (decrease) the net proceeds to us by approximately $                million, assuming the assumed initial public offering price of $                per share remains the same, and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The principal purposes of this offering are to increase our capitalization and financial flexibility, establish a public market for our common stock and to facilitate future access to the public equity markets by us, our employees and our stockholders, obtain additional capital to support our operations and increase our visibility in the marketplace.

We currently intend to use the net proceeds from this offering as follows:

 

   

approximately $                million to repay a portion of the aggregate principal amount outstanding under the Loan Agreement, and to pay accrued interest on such outstanding principal amount as well as related back-end and loan prepayment fees (described in greater detail below); and

 

   

the remainder for working capital and other general corporate purposes, including commercial expansion and clinical trial costs.

We may also use a portion of the net proceeds from this offering to in-license, acquire or invest in complementary businesses, technologies, products or assets. However, we have no current commitments or obligations to do so.

As noted above, we will use a portion of the net proceeds from this offering to (i) repay $                million of the approximately $32.0 million aggregate principal amount outstanding (excluding PIK Interest (as defined below)) under our Term Loan Agreement, dated as of September 23, 2015, by and among us, the subsidiary guarantors party thereto from time to time, CRG Partners III L.P. and certain of its affiliates, as lenders, and CRG Servicing LLC, as agent, or the Loan Agreement; (ii) pay approximately $                million of accrued interest on such outstanding principal amount; (iii) pay approximately $                million for a related back-end fee (equal to 12.0% of the principal amount being prepaid, excluding PIK Interest); and (iv) pay approximately $                million for a related loan prepayment fee (equal to up to 5.0% of the principal amount being prepaid) (in each case, assuming a payment date of                , 2021). The outstanding term loan accrues interest at a rate of 13.0% per annum, payable on a quarterly basis, and has a maturity date of June 30, 2021, with such maturity date to be automatically extended to December 31, 2021 in connection with the closing of this offering. In addition, so long as we are not in default under the Loan Agreement, we may defer up to 5.0% per annum of the interest payment, or PIK Interest, which is added to the principal balance. CRG is a beneficial owner of more than 5% of our capital stock as described in the section titled “Certain Relationships and Related Party Transactions—Term Loan Agreement.”

 

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This expected use of the net proceeds from this offering represents our intentions based on our current plans and business conditions, which could change in the future as our plans and business conditions evolve. Further, due to the uncertainties inherent in the development and commercialization of urologic genomic tests, it is difficult to estimate with certainty the exact amounts of the net proceeds from this offering that may be used for the above purposes, other than with respect to the payments associated with the Loan Agreement described above.

Our management will have broad discretion over the use of the net proceeds from this offering, and our investors will be relying on the judgment of our management regarding the application of the net proceeds of this offering. The amounts and timing of our expenditures will depend upon numerous factors, including cash flows from operations and the anticipated growth of our business, reimbursement and the results of our research and development efforts.

Although it is difficult to predict future liquidity requirements, based on our current business plan, we believe that the net proceeds from this offering, together with our existing cash and cash equivalents and our anticipated cash flows generated from sales of our products, will be sufficient to meet our anticipated cash required over at least the next        months from the date of this prospectus. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. Pending the use of the net proceeds from this offering as described above, we intend to invest the net proceeds in a variety of capital preservation instruments, including short-term, interest-bearing obligations, investment-grade instruments, certificates of deposit or direct or guaranteed obligations of the U.S. government.

 

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DIVIDEND POLICY

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all available funds and future earnings, if any, for use in the operation of our business and do not anticipate paying any cash dividends on our common stock in the foreseeable future. Any future determination to declare and pay dividends will be made at the discretion of our board of directors and will depend on various factors, including applicable laws, our results of operations, our financial condition, our capital requirements, contractual restrictions, general business conditions, our future prospects and other factors that our board of directors may deem relevant. In addition, the terms of the Loan Agreement restrict our ability to pay dividends without the prior written consent of CRG Partners III L.P. Investors should not purchase our common stock with the expectation of receiving cash dividends.

 

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CAPITALIZATION

The following table sets forth our cash and cash equivalents and our capitalization as of September 30, 2020 as follows:

 

   

on an actual basis;

 

   

on a pro forma basis to reflect (i) the conversion of all outstanding shares of our redeemable convertible preferred stock as of September 30, 2020 into an aggregate of 40,197,095 shares of common stock, and the resultant reclassification of the carrying value of our redeemable convertible preferred stock to permanent equity, in connection with the closing of this offering, and (ii) the filing and effectiveness of our amended and restated certificate of incorporation immediately prior to the completion of this offering; and

 

   

on a pro forma as adjusted basis to give effect to (i) the pro forma adjustments set forth above, (ii) the issuance and sale of                shares of our common stock in this offering at the assumed initial public offering price of $                per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and (iii) $                million of the net proceeds from this offering used to repay a portion of the aggregate principal amount outstanding under the Loan Agreement, and to pay accrued interest on such outstanding principal amount as well as related back-end, loan prepayment fees and the resultant charges, including the write-off of the proportionate unamortized debt issuance costs (for additional details, see the section titled “Use of Proceeds”).

You should read this information together with the sections titled “Selected Consolidated Financial and Other Data,” “Description of Capital Stock” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus.

 

     As of September 30, 2020  
     Actual     Pro Forma     Pro Forma
As Adjusted(1)
 
     (in thousands, except share and per share data)  
           (unaudited)  

Cash and cash equivalents

   $ 14,547     $ 14,547     $                    
  

 

 

   

 

 

   

 

 

 

Capitalization:

      

Long-term debt, related party, net of debt discount

     40,359       40,359    

Redeemable convertible preferred stock, $0.0001 par value per share; 41,809,255 shares authorized, 40,197,095 shares issued and outstanding, actual; no shares authorized, issued and outstanding, pro forma and pro forma as adjusted

     40,282       —         —    

Stockholders’ equity (deficit):

      

Preferred stock, $0.0001 par value per share; no shares authorized, issued and outstanding, actual;                 shares authorized and no shares issued and outstanding, pro forma and pro forma as adjusted

     —         —         —    

Common stock, $0.0001 par value per share; 53,069,609 shares authorized, 2,248,385 shares issued and outstanding, actual;                 shares authorized, 42,445,480 shares issued and outstanding, pro forma;                 shares authorized,                 shares issued and outstanding, pro forma as adjusted

     —         4    

Additional paid-in capital

     2,806       43,084    

Accumulated other comprehensive income

     308       308    

Accumulated deficit

     (65,202     (65,202  
  

 

 

   

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     (62,088     (21,806  
  

 

 

   

 

 

   

 

 

 

Total capitalization

   $ 18,553     $ 18,553     $                
  

 

 

   

 

 

   

 

 

 

 

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(1)

Each $1.00 increase (decrease) in the assumed initial public offering price of $                per share would increase (decrease) the pro forma as adjusted amount of each of our cash and cash equivalents, total stockholders’ equity (deficit) and total capitalization by approximately $                , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1.0 million shares in the number of shares we are offering at the assumed initial public offering price of $                share would increase (decrease) the pro forma as adjusted amounts of each of our cash and cash equivalents, total stockholders’ equity (deficit) and total capitalization by approximately $                million, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. The pro forma as adjusted information discussed above is illustrative only and will be adjusted based on the actual initial public offering price and other terms of this offering determined at pricing.

The outstanding share information in the table above excludes, as of September 30, 2020, the following:

 

   

5,868,623 shares of our common stock issuable upon the exercise of outstanding stock options as of September 30, 2020, with a weighted-average exercise price of $0.83 per share;

 

   

1,444,982 shares of our common stock issuable upon the exercise of outstanding stock options granted after September 30, 2020, with a weighted-average exercise price of $3.83 per share;

 

   

4,375 shares of our common stock issuable upon the exercise of a warrant outstanding as of September 30, 2020, with an exercise price of $13.71 per share;

 

   

167,500 shares of our common stock issuable upon the exercise of a warrant outstanding as of September 30, 2020, with an exercise price of $11.40 per share, which warrant will terminate pursuant to its terms upon the closing of this offering unless previously exercised;

 

   

                shares of our common stock reserved for future issuance under the 2021 Plan, including                shares of common stock reserved for issuance under the 2018 Plan, which shares will be added to the 2021 Plan upon its effectiveness, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective upon the execution and delivery of the underwriting agreement for this offering; and

 

   

                shares of our common stock reserved for future issuance under the ESPP, as well as any automatic increases in the number of shares of our common stock reserved for future issuance under the ESPP, which will become effective upon the execution and delivery of the underwriting agreement for this offering.

 

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DILUTION

If you invest in our common stock in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per share of our common stock and the pro forma as adjusted net tangible book value per share of our common stock immediately after this offering.

As of September 30, 2020, our historical net tangible book value (deficit) was $(62.1) million, or $(27.61) per share of our common stock, based on 2,248,385 shares of common stock outstanding as of such date. Our historical net tangible book value (deficit) per share represents the amount of our total tangible assets less total liabilities and redeemable convertible preferred stock, divided by the total number of shares of common stock outstanding at September 30, 2020.

After giving effect to the conversion of all outstanding shares of our redeemable convertible preferred stock as of September 30, 2020 into 40,197,095 shares of common stock and the resultant reclassification of the carrying value of our redeemable convertible preferred stock to permanent equity in connection with the closing of this offering, our pro forma net tangible book value (deficit) as of September 30, 2020 would have been approximately $(21.8) million, or approximately $(0.51) per share of our common stock.

After giving further effect to (i) the sale of                shares of our common stock that we are offering at the assumed initial public offering price of $            per share, the midpoint of the price range set forth on the cover page of this prospectus, after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us, and (ii) $                million of the net proceeds from this offering used to repay a portion of the aggregate principal amount outstanding under our Loan Agreement, and to pay accrued interest on such outstanding principal amount as well as related back-end, loan prepayment fees and the resultant charges, including the write-off of the proportionate unamortized debt issuance costs (for additional details, see the section titled “Use of Proceeds”), our pro forma as adjusted net tangible book value as of September 30, 2020 would have been $        million, or approximately $            per share. This amount represents an immediate increase in pro forma net tangible book value of $             per share to our existing stockholders and an immediate dilution in pro forma net tangible book value of approximately $            per share to new investors participating in this offering.

Dilution per share to new investors is determined by subtracting pro forma as adjusted net tangible book value per share after this offering from the assumed initial public offering price per share paid by new investors. The following table illustrates this dilution:

 

Assumed initial public offering price per share

     $                    

Historical net tangible book value (deficit) per share at September 30, 2020, before giving effect to this offering

   $ (27.61  

Pro forma increase in historical net tangible book value per share attributable to conversion of all outstanding shares of redeemable convertible preferred stock as of September 30, 2020 and related transactions described above

     27.10    
  

 

 

   

Pro forma net tangible book value per share at September 30, 2020, before giving effect to this offering

     (0.51  

Increase in pro forma net tangible book value per share attributable to investors participating in this offering

    
  

 

 

   

Pro forma as adjusted net tangible book value per share after this offering

    
    

 

 

 

Dilution per share to new investors participating in this offering

     $    
    

 

 

 

Each $1.00 increase (decrease) in the assumed initial public offering price of $            per share would increase (decrease) the pro forma as adjusted net tangible book value per share after this offering by

 

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approximately $            , and dilution in pro forma net tangible book value per share to new investors by approximately $            , assuming that the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each 1.0 million share increase in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase our pro forma as adjusted net tangible book value per share after this offering by approximately $        and decrease the dilution to investors participating in this offering by approximately $        per share, assuming that the assumed initial public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us. Each 1.0 million share decrease in the number of shares offered by us, as set forth on the cover page of this prospectus, would decrease the pro forma as adjusted net tangible book value per share after this offering by approximately $        and increase the dilution to investors participating in this offering by approximately $        per share, assuming that the assumed initial public offering price remains the same, and after deducting the estimated underwriting discounts and commissions and the estimated offering expenses payable by us.

If the underwriters exercise their option to purchase                 additional shares of our common stock in full in this offering, the pro forma as adjusted net tangible book value after the offering would be $        per share, the increase in pro forma as adjusted net tangible book value per share to existing stockholders would be $        per share and the dilution per share to new investors would be $        per share, in each case assuming an initial public offering price of $        per share.

To the extent that outstanding options with an exercise price per share that is less than the pro forma as adjusted net tangible book value per share are exercised, new investors will experience further dilution. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.

The following table summarizes, on a pro forma as adjusted basis as of September 30, 2020, the number of shares of common stock purchased or to be purchased from us, the total consideration paid or to be paid to us in cash and the average price per share paid by existing stockholders for shares issued prior to this offering and the price to be paid by new investors in this offering. The calculation below is based on the assumed initial public offering price of $            per share, before deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. As the table below shows, investors participating in this offering will pay an average price per share substantially higher than our existing stockholders paid.

 

     Shares Purchased     Total Consideration     Weighted-
Average
Price

Per Share
 
     Number      Percent     Amount      Percent  

Existing stockholders

          $            $                    

Investors participating in this offering

                                                               $    
  

 

 

    

 

 

   

 

 

    

 

 

   

Total

        100.0   $          100.0  
  

 

 

    

 

 

   

 

 

    

 

 

   

Each $1.00 increase (decrease) in the assumed initial public offering price of $            per share would increase (decrease) each of the total consideration paid by new investors and the total consideration paid by all stockholders by approximately $            million, assuming the number of shares offered by us, as set forth on the cover page of this prospectus, remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us. We may also increase or decrease the number of shares we are offering. Each increase (decrease) of 1.0 million shares in the number of shares offered by us, as set forth on the cover page of this prospectus, would increase (decrease) each of the total consideration paid by investors participating in this

 

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offering and the total consideration paid by all stockholders by approximately $            million, assuming the assumed initial public offering price of $            per share remains the same and after deducting the estimated underwriting discounts and commissions and estimated offering expenses payable by us.

The foregoing tables and calculations exclude:

 

   

5,868,623 shares of our common stock issuable upon the exercise of outstanding stock options as of September 30, 2020, with a weighted-average exercise price of $0.83 per share;

 

   

1,444,982 shares of our common stock issuable upon the exercise of outstanding stock options granted after September 30, 2020, with a weighted-average exercise price of $3.83 per share;

 

   

4,375 shares of our common stock issuable upon the exercise of a warrant outstanding as of September 30, 2020, with an exercise price of $13.71 per share;

 

   

167,500 shares of our common stock issuable upon the exercise of a warrant outstanding as of September 30, 2020, with an exercise price of $11.40 per share, which warrant will terminate pursuant to its terms upon the closing of this offering unless previously exercised;

 

   

                shares of our common stock reserved for future issuance under the 2021 Plan, including                shares of common stock reserved for issuance under the 2018 Plan, which shares will be added to the 2021 Plan upon its effectiveness, as well as any annual automatic increases in the number of shares of our common stock reserved for future issuance under this plan, which will become effective upon the execution and delivery of the underwriting agreement for this offering; and

 

   

                shares of our common stock reserved for future issuance under the ESPP, as well as any annual automatic increases in the number of shares of our common stock reserved for future issuance under the ESPP, which will become effective upon the execution and delivery of the underwriting agreement for this offering.

 

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SELECTED CONSOLIDATED FINANCIAL AND OTHER DATA

The following tables set forth our selected consolidated financial data and other data as of, and for the periods ended on, the dates indicated. We have derived the selected consolidated statements of operations data for the years ended December 31, 2018 and 2019 and the selected consolidated balance sheet data as of December 31, 2018 and 2019 from our audited consolidated financial statements included elsewhere in this prospectus. We have derived the selected consolidated statements of operations data for the nine months ended September 30, 2019 and 2020 and the selected consolidated balance sheet data as of September 30, 2020 from our unaudited condensed consolidated financial statements included elsewhere in this prospectus. The selected consolidated financial data included in this section are not intended to replace the consolidated financial statements and related notes included elsewhere in this prospectus. You should read the selected consolidated financial data together with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes included elsewhere in this prospectus. Our historical results are not necessarily indicative of the results to be expected for any other period in the future.

 

     Year Ended December 31,     Nine Months Ended
September 30,
 
     2018     2019     2019     2020  
                 (unaudited)  
     (in thousands, except share, per share and other data)  

Consolidated Statements of Operations Data:

        

Revenue:

        

Genomic testing

   $ 10,660     $ 15,968     $ 10,131     $ 27,382  

Other

     1,411       556       544       30  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     12,071       16,524       10,675       27,412  
  

 

 

   

 

 

   

 

 

   

 

 

 

Costs and operating expenses:

        

Cost of revenue(1)

     10,886       9,367       6,715       8,539  

Research and development(1)

     2,961       3,599       2,849       2,954  

Sales and marketing(1)

     10,906       10,203       7,141       9,304  

General and administrative(1)

     7,574       6,641       4,733       5,316  

Legal settlement

     2,551       —         —         —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and operating expenses

     34,878       29,810       21,438       26,113  
  

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

     (22,807     (13,286     (10,763     1,299  

Other income (expense), net:

        

Interest income

     8       54       35       12  

Interest expense on long-term debt – related party

     (4,233     (4,632     (3,395     (4,709

Interest expense and settlement of convertible promissory notes

     (3,768     (1,561     (1,561     —    

Revaluation of warrants and embedded derivative liabilities

     843       721       721       —    

Other income (expense), net

     45       247       200       1  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     (7,105     (5,171     (4,000     (4,696
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

     (29,912     (18,457     (14,763     (3,397

Tax expense (benefit)

     25       (6     —         (33
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss and comprehensive loss

     (29,937     (18,451     (14,763     (3,364

Accretion to redemption value of redeemable convertible preferred stock

     (4,982     (395     (395    
(1,137

Accruing dividends on redeemable convertible preferred stock with carrying value in excess of redemption value

     (731     (2,063     (1,420     (778

Deemed dividend on redeemable convertible preferred stock issuances

     —         (2,026     (2,026     —    

Gain on extinguishment of redeemable convertible preferred stock

     16,700       103,523       103,523       —    

Net income allocable to preferred stockholders

     —         (75,284     (79,063     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to common stockholders

   $ (18,950   $ 5,304     $ 5,856     $ (5,279
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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     Year Ended
December 31,
    Nine Months Ended
September 30,
 
     2018     2019     2019     2020  
           (unaudited)  
     (in thousands, except share, per share and other data)  

Net income (loss) per share attributable to common stockholders(2):

        

Basic

   $ (10.64   $ 2.48     $ 2.77     $ (2.35
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

   $ (10.64   $ (0.57   $ (0.48   $ (2.35
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average shares of common stock outstanding(2):

        

Basic

     1,780,497       2,138,072       2,110,473       2,244,284  
  

 

 

   

 

 

   

 

 

   

 

 

 

Diluted

     1,780,497       32,483,381       30,603,564       2,244,284  
  

 

 

   

 

 

   

 

 

   

 

 

 

Pro forma net loss attributable to common stockholders – basic and diluted (unaudited)(3)

     $ (19,214     $ (3,364
    

 

 

     

 

 

 

Pro forma net loss per share attributable to common stockholders – basic and diluted (unaudited)(3)

     $ (0.51     $ (0.08
    

 

 

     

 

 

 

Pro forma weighted-average shares of common stock outstanding – basic and diluted (unaudited)(3)

       37,979,639         42,441,379  
    

 

 

     

 

 

 

Other Data:

        

Genomic testing volume(4)

     10,655       11,538       8,123       11,812  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)   Includes stock-based compensation expense as follows:

        
     Year Ended December 31,     Nine Months Ended
September 30,
 
     2018     2019     2019     2020  
           (unaudited)  
     (in thousands)  

Cost of revenue

    $ 8     $ 44     $ 25     $ 57  

Research and development

     109       273       211       189  

Sales and marketing

     80       185       100       248  

General and administrative

     248       432       270       681  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

    $ 445     $ 934     $ 606     $ 1,175  
  

 

 

   

 

 

   

 

 

   

 

 

 

 

(2)

See Note 1 to each of our audited consolidated financial statements and our unaudited condensed consolidated financial statements included elsewhere in this prospectus for a description of how we compute historical basic and diluted net loss per share and the weighted-average number of shares used in the computation of these per share amounts.

(3)

Our pro forma net loss per share attributable to common stockholders – basic and diluted assumes all shares of our redeemable convertible preferred stock outstanding at the end of each period had converted into common stock at the beginning of each respective period. As a result of the assumed conversion of our redeemable convertible preferred stock at the beginning of each period, the pro forma net loss attributable to common stockholders – basic and diluted equals the net loss for the nine months ended September 30, 2020 and equals the net loss for the year ended December 31, 2019, less $0.8 million related to the change in fair value of the preferred stock warrants liability.

(4)

Genomic testing volume represents the total number of genomic test results delivered to ordering physicians and pharmaceutical partners.

 

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     As of December 31,     As of
September 30,
 
     2018     2019     2020  
           (unaudited)  
     (in thousands)  

Consolidated Balance Sheet Data:

      

Cash and cash equivalents

   $ 4,276     $ 4,542     $ 14,547  

Total assets

     8,345       19,291       29,690  

Working capital (deficit)(1)

     (33,765     2,174       (27,175

Long-term debt, related party, net of debt discount

     28,782       35,930       40,359  

Redeemable convertible preferred stock

     110,135       29,821       40,282  

Accumulated deficit

     (147,567     (61,838     (65,202

Total stockholders’ equity (deficit)

     (144,121     (58,763     (62,088

 

(1)

Working capital is calculated as current assets less current liabilities. See our consolidated financial statements and related notes included elsewhere in this prospectus for further details regarding our current assets and current liabilities.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL

CONDITION AND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our financial statements and related notes and other financial information included elsewhere in this prospectus. This discussion and analysis and other parts of this prospectus contain forward-looking statements based upon our current plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projection. Our actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under the section titled “Risk Factors” and elsewhere in this prospectus. Please also see the section titled “Special Note Regarding Forward-Looking Statements.”

Overview

We are a commercial-stage precision oncology company committed to improving patient care, with a focus in urologic oncology specific to prostate and bladder cancers. Our novel prostate cancer genomic testing products, Decipher Biopsy and Decipher RP, provide valuable information about the underlying biology of a patient’s tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient’s entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Collectively, our genomic tests have been used by more than 3,200 urologists and radiation oncologists, and at all 28 NCCN centers in the United States. Our prostate cancer products are covered by Medicare in nine clinical indications, representing the entire known spectrum of localized, regional and biochemically recurrent prostate cancer. Six of our clinical indications received Medicare coverage in 2020. Our whole transcriptome analysis of clinical patient samples from our commercial channel and our participation in practice-changing clinical trials has allowed us to build and expand Decipher GRID, one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID is our proprietary engine that drives product development for us and our pharmaceutical partners.

 

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We have developed a suite of products to guide therapy selection across the prostate cancer care continuum that align with NCCN guidelines. The timeline of our product portfolio is summarized below:

 

LOGO

In 2015, we received an LCD for our first commercial product, Decipher RP, for use in the early salvage setting. We expanded into biopsy and received an LCD for first two Decipher Biopsy products in May 2019 covering the Very Low and Low NCCN risk groups and a second LCD in January 2020 covering Decipher Biopsy for Favorable Intermediate and Unfavorable Intermediate NCCN risk groups. In November 2020, we launched our High and Very High biopsy products and now cover the entire localized and biochemically recurrent prostate cancer care continuum. We have processed over 90,000 samples since inception. Our genomic testing volume grew 45% to 11,812 tests for the nine months ended September 30, 2020 from 8,123 tests in for the nine months ended September 30, 2019.

Our current product development pipeline includes expansion of indications for Decipher testing to castrate-resistant and metastatic prostate cancer, predictive biomarkers for response to ADT, second generation ARSi and docetaxel chemotherapy. Predictive biomarkers are used by physicians to optimally select the drug for which a patient’s tumor is most sensitive to its inhibitory effects. We believe our pipeline of clinical trials will provide opportunities to validate several predictive biomarkers that will enable us to expand the market for our products, drive adoption among existing customers and increase penetration of our product offerings with newer customers such as radiation oncologists and medical oncologists. We also plan to continue to develop additional products for unmet needs within urologic cancers, including kidney cancer.

We market our products primarily to urologists and radiation oncologists in the United States, as well as to pharmaceutical companies for use in their clinical trials and product development. The ordering physicians are not responsible for payment for our tests, which are paid for by third-party payors, including Medicare and commercial payors, and to a small extent, patients who self-pay. We have Medicare coverage pursuant to LCDs with Noridian providing Medicare reimbursement for our currently marketed Decipher RP and Decipher Biopsy

 

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Very Low, Low, Favorable Intermediate, Unfavorable Intermediate, High and Very High tests. We also received draft Medicare coverage in April 2020 covering muscle invasive and non-muscle invasive bladder cancer, for which we expect final Medicare coverage in mid-2021.

In August 2019, we initiated a sales expansion strategy to grow our sales force. We expanded from 12 sales representatives in July 2019 to 17 sales representatives at year end 2019. We continued our sales force expansion into 2020, and as of December 31, 2020, we had 25 sales representatives covering 25 sales territories across the United States, which are specifically aligned with the high-volume surgeons and radiation oncologists. The number of sales representatives and the number of genomic test results we generate are key indicators that we use to assess our business. We also market our products to pharmaceutical companies through our business development team, which promotes the use of Decipher test results and Decipher GRID to assist in stratifying patient populations in pharmaceutical clinical trials and drug development.

We perform all Decipher tests in our 28,400 square foot facility located in San Diego, California. The laboratory at this facility is CLIA-certified, CAP-accredited, New York State DOH-permitted and licensed in many states, including California, Maryland, Pennsylvania and Rhode Island.

The laboratory is staffed by a full-time team of laboratory technicians, histologists, automation engineers, clinical laboratory scientists, a board-certified pathologist, a medical and laboratory director and quality management personnel. We estimate that our current annual sample processing capacity of the lab is approximately 20,000. We have initiated the process of adding personnel and automating portions of assay workflow, the results of which are expected to increase annual processing capacity by 10,000 samples by the end of 2021. We believe this is sufficient capacity to accommodate our next 12 months of growth; however, we may need to continue to add additional laboratory personnel and/or equipment beyond that time.

Since our inception in 2008, we have devoted substantially all of our resources to research, development, clinical trials, reimbursement, raising capital and commercialization activities for our products and have funded our operations primarily through the sale of our equity securities, convertible promissory notes and borrowings under the Loan Agreement with CRG. We generated total revenue of $12.1 million, $16.5 million and $27.4 million for the years ended December 31, 2018 and 2019 and the nine months ended September 30, 2020,

respectively, and incurred net losses of $29.9 million, $18.5 million and $3.4 million, respectively, during those periods. Although our revenue has increased sequentially year-over-year, we had never been profitable until the three months ended September 30, 2020 and, as of September 30, 2020, we had an accumulated deficit of $65.2 million. We expect to continue to incur significant expenses and operating losses in the future to support the growth of our business, as well as incur additional costs associated with being a public company.

Factors Affecting Our Performance

We believe there are several critical factors that have impacted and that we expect will continue to impact our operating performance and results of operations. While many of these factors present significant opportunities for our business, they also pose important challenges that we must successfully address in order to sustain our growth and improve our results of operations. Our ability to successfully address many of the factors below is subject to various risks and uncertainties, including those described in the section titled “Risk Factors.”

Impact of COVID-19 Pandemic

The COVID-19 pandemic has disrupted, and we expect will continue to disrupt, our operations. Employees who can perform their duties remotely are asked to work from home and those on site are asked to follow our social distance guidelines. Our sales, marketing and business development efforts have also been constrained by our operational response to the COVID-19 pandemic due to travel restrictions. We expect to continue to adjust our operational norms in an effort to help slow the spread of COVID-19 in the coming months, including complying with government directives and guidelines as they are modified and supplemented.

 

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The COVID-19 pandemic also has started to negatively affect, and we expect will continue to negatively affect our testing-related revenue and our clinical studies. For example, cancer patients may have more limited access to hospitals, healthcare providers and medical resources as they take steps to control the spread of COVID-19. Our biopharmaceutical partners are facing challenges in recruiting patients and in conducting clinical trials to advance their pipelines, for which our tests could be utilized. As a result of the COVID-19 pandemic, beginning in the second quarter of 2020, we experienced a reduction in genomic testing volume of 14%, as compared to the first quarter of 2020, which we believe is linked to delays and/or cancellations in patient visits and thus lower genomic testing volume from ordering physicians in response to COVID-19. While we are unable to predict the pace, timing or occurrence of any rescheduled patient visits, we anticipate that a majority of these delayed and/or canceled patient visits will be subsequently rescheduled as applicable restrictions and guidelines are eased, which we believe is supported by recent metrics available to us. For example, for the third quarter of 2020, total genomic testing volumes increased 8% and 25% as compared to the first quarter and second quarter of 2020, respectively.

Ability to Attract New Ordering Physicians and Increase Our Penetration with Existing Physicians. While our overall genomic test volume has grown in each quarter in 2019 and 2020, continued revenue growth for our products will depend on our ability to continue to expand our base of ordering physicians and increase our penetration with existing physician customers. In August 2019, we initiated a sales expansion strategy to grow our sales team from 12 sales representatives to 17 by year-end 2019. We continued our sales force expansion into 2020, and as of December 31, 2020, our sales team consisted of 25 sales representatives. We plan to expand to 34 total sales representatives by year end 2021. Our sales territories are specifically aligned with the high-volume surgeons and radiation oncologists within the United States. As we continue to hire new sales representatives, we expect generally to have a three-quarter ramp for each new representative, as they gain experience to sell our tests and build their physician customer base.

Reimbursement for Genomic Testing from Third-Party Payors. The substantial majority of revenue for our products is reimbursement from third-party payors, which includes government payors such as Medicare, and commercial payors such as insurance companies. To date, we have obtained Medicare coverage and limited reimbursement coverage from third-party commercial payors for our currently marketed products. Payor mix has the potential to significantly affect our results of operations, as the average price between different groups of payors is generally subject to greater variability. Our revenue growth depends significantly on achieving broad coverage and reimbursement. Payors require extensive evidence of clinical utility, clinical validity, patient outcomes and health economic benefits to support reimbursement. As we continue to develop this supporting clinical evidence, we anticipate our commercial insurance coverage will increase over time. We are also actively working to expand the commercial payors that cover our product offerings.

As part of our effort to develop supporting clinical evidence to obtain Medicare coverage for Decipher Biopsy Very Low, Low and Favorable Intermediate indications, we processed and delivered results for these tests in 2018 and 2019 prior to receiving Medicare coverage. Ultimately, Medicare coverage was not received for Decipher Biopsy Very Low and Low until May 2019, and Medicare coverage for Decipher Biopsy Favorable Intermediate was not received until January 2020. Medicare represented 29% and 31% of our overall genomic testing volume in 2018 and 2019, respectively, of which 13% and 12%, respectively, represented Decipher Biopsy tests for patients covered by Medicare in each case prior to our LCDs becoming effective. As a result of processing these tests that were not covered by Medicare, we incurred substantial costs with minimal associated revenue related to these tests. These costs, combined with low commercial third-party payor reimbursement, resulted in a negative overall gross margin until the second quarter of 2019. The LCD we received in May 2019 for Decipher Biopsy Very Low and Low contributed to an overall positive gross margin, which was further improved with the effectiveness of the LCD for Decipher Biopsy Favorable Intermediate in January 2020. Beginning in the first quarter of 2020, our revenue per test increased considerably, because for the first time we were reimbursed for substantially all tests delivered on behalf of patients with Medicare.

 

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Ability to Attract New Pharmaceutical Partners and Expand Relationships with Our Existing Pharmaceutical Partners. We have existing partnerships with several large multi-national pharmaceutical companies. Our business development team promotes the broad utility of our products both domestically and internationally. Our revenue and business opportunities depend in part on our ability to attract new pharmaceutical partners and to maintain and expand relationships with our existing pharmaceutical partners.

If we are successful developing relationships with pharmaceutical companies, we believe we may have opportunities to offer our tests and Decipher GRID for companion diagnostic development, clinical trial design, novel target discovery and validation, and to grow into other commercial opportunities. We believe our raw genomic data, in combination with our clinical outcomes and claims data, has revenue-generating potential, including for novel target identification or clinical trial design.

The timing and size of sample shipments from pharmaceutical partners are often variable depending on the retrospective versus prospective nature of the underlying sample cohorts. Since sample shipments can be large, and are often received from a third-party holding facility, the timing of arrival can be difficult to predict over the short term. Although our long-term performance is not affected, we do see quarter-to-quarter volatility in our revenue from pharmaceutical partners due to these factors. Samples arriving later than expected may not be processed in the planned quarter and therefore may result in revenue the following quarter. Since many of our customers request defined turnaround times, we employ project managers to coordinate and manage the complex process from sample receipt to genomic data generation to delivery of results.

Product Innovation and Investment to Support Commercial Growth. Introducing innovative and transformative products to the marketplace has been a cornerstone of our competitive advantage and is critical for our future success. We believe that we are uniquely positioned to be able to support testing for all prostate and bladder cancer patients. We are collaborating with investigators from the National Cancer Institute as well as academic cancer centers such as the University of Michigan, Northwestern University, UCSF, UCI, and Thomas Jefferson University, to support the utility of our products. We believe this work is critical to garnering support from KOLs and accelerating customer adoption and we expect our investments in these efforts to increase. The timing of these research and development activities is difficult to predict, and the related expenses may vary significantly by quarter. We expect to increase our research and development expense with the goal of developing further utility studies for our existing products as well as developing new products.

Financial Overview

Revenue

We derive our revenue primarily from genomic testing and, to a much lesser degree, other revenue. The following descriptions relate to our revenue recognition under Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, upon adoption on January 1, 2019. Prior to its adoption, we recognized revenue under ASC Topic 605. See Note 1 to our audited consolidated financial statements included elsewhere in this prospectus.

Genomic Testing. Genomic testing revenue is generated from the sale of genomic testing products to physicians and pharmaceutical partners.

Under ASC Topic 606, revenue is recognized when control of the promised goods or services is transferred to customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. To determine revenue recognition for the arrangements we determine are within the scope of ASC Topic 606, we perform the following five steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation. The estimated uncollectible amounts that were classified as bad debt expense under ASC Topic 605 are generally considered implicit price concessions under ASC Topic 606 that are a direct reduction to accounts receivable rather than allowance for doubtful accounts.

 

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The majority of our revenue has been derived from the sale of genomic testing products. We estimate the transaction price for our genomic testing products at the amount of consideration we expect to be entitled to receive in exchange for providing services, based on our historical collection experience, using a portfolio approach as a practical expedient to account for patient contracts as collective groups rather than individually. We monitor our estimates of transaction price to depict conditions that exist at each reporting date. If we subsequently determine that we will collect more consideration than originally estimated for a contract with a patient, we will account for the change as an increase in the estimate of the transaction price in the period identified. Similarly, if we subsequently determine that the amount we expect to collect from a patient is less than originally estimated, we will generally account for the change as a decrease in the estimate of the transaction price in the period identified.

Our performance obligations are satisfied at the point in time when genomic testing results are delivered. For customers with whom we have a contract as defined in ASC Topic 606, we recognize revenue upon delivery of the genomic testing results, at the amount of consideration to which we expect to be entitled, or an Accrual Basis. For customers with whom we have delivered genomic testing results but do not have a contract as defined in ASC Topic 606, we recognize revenue when we receive the related consideration, or a Cash Basis. Under ASC Topic 606, we generally recognize revenue from Medicare, select commercial payors and pharmaceutical partners on an Accrual Basis. Substantially all of our revenue from commercial payors are currently recognized on a Cash Basis as it is not probable that we will collect substantially all of the consideration to which we are entitled.

Genomic testing revenue from our pharmaceutical partners can vary over time as different trials start, progress, and complete.

The following table sets forth the genomic testing revenue recognized for the periods presented. You should read this information together with our audited consolidated financial statements and unaudited condensed consolidated financial statements and related notes included elsewhere in this prospectus. Historical results are not necessarily indicative of results to be expected in future periods.

 

     Year Ended December 31,      Nine Months Ended
September 30,
 
         2018              2019              2019              2020      
     (in thousands)  

Medicare

   $ 3,584      $ 7,823      $ 5,860      $ 13,923  

Commercial payors

     3,425        5,248        3,604        10,161  

Patients

     414        790        592        1,189  

Pharmaceutical partners

     3,237        2,107        75        2,109  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total genomic testing revenue

   $ 10,660      $ 15,968      $ 10,131      $ 27,382  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     Year Ended December 31,      Nine Months Ended
September 30,
 
         2018              2019              2019              2020      
     (in thousands)  

Genomic testing revenue – cash basis

   $ 3,521      $ 5,812      $ 3,986      $ 11,350  

Genomic testing revenue – accrual basis

     7,139        10,156        6,145        16,032  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total genomic testing revenue

   $ 10,660      $ 15,968      $ 10,131      $ 27,382  
  

 

 

    

 

 

    

 

 

    

 

 

 

Effective January 1, 2019, we began recognizing revenue in accordance with the provisions of ASC Topic 606, using the modified retrospective method, which applies the new standard prospectively and therefore does not impact prior years’ reported revenue. The adoption of ASC 606 did not result in a material change in revenue for the year ended December 31, 2019.

 

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Other Revenue. Other revenue was primarily related to commissions paid to us by a third-party utilizing our commercial sales force to sell their complementary product into physician offices. We terminated the agreement in May 2019 and do not anticipate any meaningful revenue related to that contract on a go forward basis. To the extent we enter into contracts for services other than genomic testing with pharmaceutical partners, our other revenue may increase in future periods.

Cost and Operating Expenses

Cost of Revenue. Cost of revenue includes the cost of materials, personnel-related expenses (comprised of salaries and bonuses, benefits and stock-based compensation), shipping and handling, royalties, equipment and allocated overhead costs associated with processing samples. Allocated overhead costs include depreciation of laboratory equipment, facility occupancy and information technology costs. Costs associated with processing samples are recorded as expense, regardless of the timing of revenue recognition. As such, cost of revenue and related volume does not always trend in the same direction as revenue recognition. Royalties for licensed technology are calculated as a percentage of revenue generated using the associated technology and recorded as expense at the time the related revenue is recognized (for additional details, see the section titled “Business—License Agreements” and Note 4 to our consolidated financial statements included elsewhere in this prospectus).

We expect that our cost of revenue will continue to increase in absolute dollars as we grow test volume. However, we expect that the cost per sample will modestly decrease over the long term due to the efficiencies we may gain due to economies of scale from improved utilization of our capacity associated with volume increases, automation and other engineering initiatives.

Research and Development. Research and development expenses consist of costs incurred for the development of our products. These expenses consist primarily of payroll and personnel costs (comprised of salaries and bonuses, benefits and stock-based compensation), reagents and supplies, clinical studies, outside services and allocated overhead, including depreciation of laboratory equipment, facility occupancy and information technology costs. We also include in research and development expenses the costs associated with assay improvements and automation workflow development activities to support laboratory scaling. We expense our research and development expenses in the period in which they are incurred.

We expect that our research and development expenses will continue to increase in absolute dollars as we continue to develop additional products, expand Decipher GRID and conduct or support ongoing and new clinical studies. However, we expect that these expenses will decrease modestly as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.

Sales and Marketing. Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct clinical sales force and sales management, medical affairs, client services, marketing and managed care, as well as business development personnel who are focused on sales to our pharmaceutical partners. These expenses consist primarily of payroll and personnel costs (comprised of salaries and bonuses, commissions, benefits and stock-based compensation), customer education and promotional expenses, market analysis expenses, conference fees, travel expenses and allocated overhead costs.

We expect that our sales and marketing expenses will continue to increase in absolute dollars as we continue our commercial expansion and increase our marketing activities to drive further awareness and adoption of our products. However, we expect that these expenses will decrease modestly as a percentage of revenue over the long term, though they may fluctuate as a percentage from period to period due to the timing and extent of these expenses.

General and Administrative. Our general and administrative expenses include costs for our executive, accounting and finance, legal, billing and human resources functions. These expenses consist primarily of payroll

 

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and personnel costs (comprised of salaries and bonuses, benefits and stock-based compensation), travel, as well as professional services fees such as consulting, accounting, legal, general corporate costs and allocated overhead costs.

We expect that our general and administrative expenses will continue to increase in absolute dollars primarily due to increased headcount and costs associated with operating as a public company, including expenses related to legal, accounting, regulatory, tax, maintaining compliance with exchange listing and requirements of the SEC, director and officer insurance and investor relations.

Legal Settlement. In December 2018, we reached an agreement with the Department of Justice, OIG, the California Department of Insurance and the qui tam relators to resolve a matter in connection with an investigation into possible false or otherwise improper claims submitted for payment under Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act through payments of $2.0 million to the United States and $0.6 million to the State of California, plus attorney fees and expenses totaling $0.1 million, and without any admission of liability or ongoing obligations. In February 2019, we made all settlement payments.

Other Income (Expense), Net

Interest Income. Interest income consists primarily of interest earned on our money market account. Our interest income has not been significant to date, but we expect interest income to increase as we invest the net proceeds from this offering.

Interest Expense on Long-Term Debt – Related Party. Interest expense on long-term debt – related party consists primarily of cash and non-cash interest on borrowings under our Loan Agreement. We intend to use a portion of the net proceeds from this offering to repay, prior to the contractual maturity date, a portion of the aggregate principal amount outstanding under our Loan Agreement, and to pay accrued interest on such outstanding principal amount as well as related back-end, loan prepayment fees and the resultant charges, including the write-off of the proportionate unamortized debt issuance costs (for additional details, see the section titled “Use of Proceeds”). We anticipate such payment will result in a decrease in our interest expense following the completion of this offering.

Interest Expense and Settlement of Convertible Promissory Notes. Interest expense and settlement of convertible promissory notes consists primarily of cash and non-cash interest and settlements related to the various convertible promissory notes we issued during 2017, 2018 and 2019. As of March 29, 2019, all of our convertible promissory notes had converted into our redeemable convertible preferred stock.

Revaluation of Warrants and Embedded Derivative Liabilities. We have issued freestanding warrants to purchase shares of our convertible preferred stock. We classify our outstanding warrants to purchase shares of our redeemable convertible preferred stock as liabilities on our balance sheet at their estimated fair value since the underlying redeemable convertible preferred stock is classified as temporary equity. At the end of each reporting period, changes in the estimated fair value during the period are recorded as a component of other income (expense). In 2019, all outstanding preferred stock warrants were adjusted to a final fair value of $0 in connection with their cancellation as part of our Series 3 preferred stock financing. Prior to cancellation, the preferred stock warrants liability was recorded at fair value utilizing the Black-Scholes option pricing model using significant unobservable inputs consistent with the inputs used for our stock-based compensation expense adjusted for the preferred stock warrant’s expected life and the fair value of the underlying preferred stock. The fair value of our preferred stock is derived from the models described below that we used to value our common stock. See Note 2 to our audited consolidated financial statements included elsewhere in this prospectus for information concerning certain of the specific assumptions we used in applying the Black-Scholes model to determine the estimated fair value of our preferred stock warrants liability in the years ended December 31, 2018 and 2019.

 

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The convertible promissory notes we issued from November 2017 through March 2019 contained redemption features which we determined were embedded derivatives to be recognized as liabilities and measured at fair value. At the end of each reporting period, changes in the estimated fair value during the period are recorded as a component of other income (expense). Subsequent to March 2019, when the last of the outstanding convertible promissory notes was converted into shares of our redeemable convertible preferred stock, we no longer have an outstanding embedded derivative liability. Prior to such conversion, the embedded derivative liability was recorded at fair value utilizing an income approach that identified the cash flows using a “with-and-without” valuation methodology. The inputs used to determine the estimated fair value of the derivative instrument were based primarily on the probability of an underlying event triggering the embedded derivative occurring and the timing of such event. We recognized a settlement loss in connection with the conversion of certain convertible promissory notes upon the closing of our Series D preferred stock financing in 2018.

Tax Expense (Benefit)

Income taxes include taxation in the United States, Canada and various state and provincial jurisdictions.

Results of Operations

Comparison of the Nine Months Ended September 30, 2019 and 2020

 

     Nine Months Ended
September 30,
    Change  
           2019                 2020           $     %  
     (in thousands)  

Revenue:

        

Genomic testing

   $ 10,131     $ 27,382     $ 17,251       170

Other

     544       30       (514     (94
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     10,675       27,412       16,737       157  

Cost and operating expenses:

        

Cost of revenue(1)

     6,715       8,539       1,824       27  

Research and development(1)

     2,849       2,954       105       4  

Sales and marketing(1)

     7,141       9,304       2,163       30  

General and administrative(1)

     4,733       5,316       583       12  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost and operating expenses

     21,438       26,113       4,675       22  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (10,763     1,299       12,062       (112

Other income (expense), net:

        

Interest income

     35       12       (23     (66

Interest expense on long-term debt – related party

     (3,395     (4,709     (1,314     39  

Interest expense and settlement of convertible promissory notes

     (1,561     —         1,561       —    

Revaluation of warrants and embedded derivative liabilities

     721       —         (721     —    

Other income (expense)

     200       1       (199     (100
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     (4,000     (4,696     (696     17  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

     (14,763     (3,397     11,366       (77

Tax expense (benefit)

     —         (33     (33     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss and comprehensive loss

   $ (14,763   $ (3,364   $ 11,399       (77 )% 
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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(1)

Includes stock-based compensation expense as follows:

 

     Nine Months Ended
September 30,
 
    

      2019      

    

      2020      

 
     (in thousands)  

Cost of revenue

   $ 25      $ 57  

Research and development

     211        189  

Sales and marketing

     100        248  

General and administrative

     270        681  
  

 

 

    

 

 

 

Total

   $ 606      $ 1,175  
  

 

 

    

 

 

 

Revenue. Revenue increased $16.7 million, or 157%, for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This increase of $16.7 million was primarily due to an increase in genomic testing revenue of $17.3 million as a result of higher genomic testing volume and increased revenue per report due in part to the approval of the Medicare coverage for Decipher Biopsy Very Low and Low in May 2019 and Favorable Intermediate in January 2020. The increase consists of a $8.1 million increase in revenue from Medicare, a $7.2 million increase in revenue related to our commercial payors and patients as a result of higher cash collections, and an increase in revenue from pharmaceutical partners of $2.0 million due to a higher volume of samples processed through September 30, 2020. Other revenue decreased $0.5 million as commission revenue from the third party utilizing our commercial sales force to sell their complementary product into physician offices decreased subsequent to termination of the agreement in May 2019.

Cost of Revenue. Cost of revenue increased $1.8 million, or 27%, for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This increase was primarily due to an increase of $1.1 million in commercial sample costs due to higher volume, an increase of $0.3 million in compensation expense due to additional headcount in our laboratory testing operations, and an increase of $0.4 million in facility and related costs due to our new lease.

Research and Development Expense. Research and development expense increased $0.1 million, or 4%, for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This increase was primarily due to the timing of samples for clinical studies and related expenses.

Sales and Marketing Expense. Sales and marketing expense increased $2.2 million, or 30%, for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This increase was primarily due to a $2.0 million increase in compensation expense due to our commercial expansion, a $0.1 million increase in allocated facility and related costs and a $0.1 million increase in stock-based compensation.

General and Administrative Expense. General and administrative expense increased $0.6 million, or 12%, for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This increase was primarily due to a $0.4 million increase in stock-based compensation, a $0.2 million increase in compensation expense, a $0.2 million increase in billing fees associated with higher revenues and a $0.1 million increase in tax and tax compliance costs, offset by a $0.3 million decrease in legal expenses.

Interest Income. Interest income decreased $23,000, or 66%, for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This decrease was primarily due to lower overall interest rates during the nine months ended September 30, 2020 as compared to the nine months ended September 30, 2019.

Interest Expense on Long-Term Debt – Related Party. Interest expense on long-term debt – related party increased $1.3 million, or 39%, for the nine months ended September 30, 2020 compared to the nine months

 

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ended September 30, 2019. This increase was primarily due to an increase in the overall debt balance associated with new borrowings, increased cash interest charges, interest charges for accumulated PIK interest balances and increased back-end fee amortization in connection with higher average outstanding balances on our Loan Agreement.

Interest Expense and Settlement of Convertible Promissory Notes. Interest expense and settlement of convertible promissory notes decreased $1.6 million for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This decrease was primarily due to the settlement of all outstanding convertible promissory notes in March 2019 in connection with our Series 3 preferred stock financing.

Revaluation of Warrants and Embedded Derivative Liabilities. Revaluation of warrants and embedded derivative liabilities decreased $0.7 million for the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. This decrease was primarily due to the settlement of our outstanding warrants liability and embedded derivative liabilities in March 2019 in connection with our Series 3 preferred stock financing.

Comparison of the Years Ended December 31, 2018 and 2019

 

     Year Ended December 31,     Change  
           2018                 2019           $     %  
     (in thousands)  

Revenue:

        

Genomic testing

   $ 10,660     $ 15,968     $ 5,308       50

Other

     1,411       556       (855     (61
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     12,071       16,524       4,453       37  

Cost and operating expenses:

        

Cost of revenue(1)

     10,886       9,367       (1,519     (14

Research and development(1)

     2,961       3,599       638       22  

Sales and marketing(1)

     10,906       10,203       (703     (6

General and administrative(1)

     7,574       6,641       (933     (12

Legal settlement

     2,551       —         (2,551     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total cost and operating expenses

     34,878       29,810       (5,068     (15
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (22,807     (13,286     9,521       (42

Other income (expense), net:

        

Interest income

     8       54       46       575  

Interest expense on long-term debt – related party

     (4,233     (4,632     (399     9  

Interest expense and settlement of convertible promissory notes

     (3,768     (1,561     2,207       (59

Revaluation of warrants and embedded derivative liabilities

     843       721       (122     (14

Other income (expense)

     45       247       202       449  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     (7,105     (5,171     1,934       (27
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss before income tax

     (29,912     (18,457     11,455       (38

Tax expense (benefit)

     25       (6     (31     (124
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss and comprehensive loss

   $ (29,937   $ (18,451   $ 11,486       (38 )% 
  

 

 

   

 

 

   

 

 

   

 

 

 

 

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(1)

Includes stock-based compensation expense as follows:

 

     Year Ended December 31,         
           2018                  2019                      
     (in thousands)                

Cost of revenue

   $ 8      $ 44                                  

Research and development

     109        273        

Sales and marketing

     80        185        

General and administrative

     248        432        
  

 

 

    

 

 

       

Total

   $        445      $        934        
  

 

 

    

 

 

       

Revenue. Revenue increased $4.5 million, or 37%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This increase of $4.5 million was primarily due to an increase in genomic testing revenue of $5.3 million as a result of higher genomic testing volume and increased revenue per report due in part to the approval of the Medicare coverage for Decipher Biopsy Very Low and Low in May 2019. The increase consists of a $4.2 million increase in revenue from Medicare and a $2.2 million increase in revenue related to our commercial payors and patients as a result of higher cash collections, offset by a decrease in revenue from pharmaceutical partners of $1.1 million due to a lower volume of samples processed in 2019 offset by higher revenue per sample. Other revenue decreased $0.8 million as commission revenue from the third party utilizing our commercial sales force to sell their complementary product into physician offices decreased subsequent to termination of the agreement in May 2019.

The adoption of ASU 2014-09, Revenue from Contracts with Customers (Topic 606), did not result in a material change in revenue for the year ended December 31, 2019.

Cost of Revenue. Cost of revenue decreased $1.5 million, or 14%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This decrease was primarily a result of reductions in our cost per test for commercial sample materials and pathology and allocated overhead, offset by an increase in our genomic testing volume.

Research and Development Expense. Research and development expense increased $0.6 million, or 22%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This increase was primarily due to a $0.5 million increase in clinical study and related costs, a $0.2 million increase in stock-based compensation expense, and a $0.1 million increase in compensation expense, offset by a $0.2 million decrease in allocated facility and related expenses.

Sales and Marketing Expense. Sales and marketing expense decreased $0.7 million, or 6%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This decrease was primarily due to a $1.2 million decrease in compensation expense upon the reorganization of our sales and marketing function in late 2018 and revision of our commission plan effective in January 2019, and a $0.2 million decrease in allocated facility and related costs, offset by a $0.5 million increase in travel, training, conferences and costs related to the expansion of our sales and marketing headcount in the second half of 2019, a $0.1 million increase in recruiting expenses and a $0.1 million increase in stock-based compensation.

General and Administrative Expense. General and administrative expense decreased $0.9 million, or 12%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This decrease was primarily due to a $0.9 million decrease in legal fees primarily related to the legal settlement we reached in December 2018 and paid in February 2019, a $0.4 million decrease in compensation expense due to reorganization of our general and administrative function in late 2018, and a $0.5 million net decrease in other expenses due to benefits from cost reduction activities, offset by a $0.4 million increase in audit and tax expenses, a $0.3 million increase in employee bonuses, and a $0.2 million increase in stock-based compensation.

 

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Legal Settlement. Legal settlement decreased $2.6 million for the year ended December 31, 2019 compared to the year ended December 31, 2018. This decrease was primarily due to the determination of the full settlement amount in December 2018 and no legal settlements in 2019.

Interest Income. Interest income increased $46,000, or 575%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This increase was primarily due to higher average cash balances during 2019.

Interest Expense on Long-Term Debt – Related Party. Interest expense on long-term debt – related party increased $0.4 million, or 9%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This increase was primarily due to increased interest charges for accumulated PIK interest balances and increased back-end fee rate in connection with the amendment of our Loan Agreement.

Interest Expense and Settlement of Convertible Promissory Notes. Interest expense decreased $2.2 million, or 59%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This decrease was primarily due to the beneficial conversion features related to the convertible promissory notes settled in 2018.

Revaluation of Warrants and Embedded Derivative Liabilities. Revaluation of warrants and embedded derivative liabilities decreased $0.1 million, or 14%, for the year ended December 31, 2019 compared to the year ended December 31, 2018. This decrease was primarily due to lower decreases in the fair value of our warrants liability, offset by lower increases in the fair value of our embedded derivative liability.

 

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Quarterly Results of Operations

The following table sets forth selected unaudited consolidated quarterly data for each of the quarters in fiscal year 2019 and the nine months ended September 30, 2020. In our opinion, the following selected unaudited consolidated quarterly statements of operations data have been prepared on the same basis as the audited consolidated financial statements included elsewhere in this prospectus and reflect all necessary adjustments, consisting only of normal recurring adjustments, necessary for fair presentation of these data. You should read this information together with our audited consolidated financial statements and unaudited condensed consolidated financial statements and related notes included elsewhere in this prospectus. Historical results are not necessarily indicative of results to be expected in future periods.

 

    Three Months Ended  
    March 31,
2019
    June 30,
2019
    September 30,
2019
    December 31,
2019
    March 31,
2020
    June 30,
2020
    September 30,
2020
 
    (in thousands)  

Revenue:

             

Genomic testing

  $ 2,060     $ 4,011     $ 4,060     $ 5,837     $ 7,853     $ 8,578     $ 10,951  

Other

    315       189       40       12       22       1       7  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

    2,375       4,200       4,100       5,849       7,875       8,579       10,958  

Cost and operating expenses:

             

Cost of revenue(1)

    2,434       2,234       2,047       2,652       3,021       2,513       3,005  

Research and development(1)

    609       1,229       1,011       750       945       917       1,092  

Sales and marketing(1)

    2,236       2,370       2,535       3,062       3,500       2,876       2,928  

General and administrative(1)

    1,544       1,563       1,626       1,908       1,794       1,747       1,775  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total cost and operating expenses

    6,823       7,396       7,219       8,372       9,260       8,053       8,800  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) from operations

    (4,448     (3,196     (3,119     (2,523     (1,385     526       2,158  

Total other income (expense), net

    (1,677     (1,179     (1,144     (1,171     (1,481     (1,590     (1,625
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Income (loss) before income tax

    (6,125     (4,375     (4,263     (3,694     (2,866     (1,064     533  

Income tax benefit

    —         —         —         (6     —         —         (33
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) and comprehensive income (loss)

  $ (6,125   $ (4,375   $ (4,263   $ (3,688   $ (2,866   $ (1,064   $ 566  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Genomic testing volume(2)

    2,549       2,969       2,605       3,415       4,005       3,464       4,343  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(1)

Includes stock-based compensation expense as follows:

 

    Three Months Ended  
    March 31,
2019
    June 30,
2019
    September 30,
2019
    December 31,
2019
    March 31,
2020
    June 30,
2020
    September 30,
2020
 
    (in thousands)  

Cost of revenue

  $ 2     $ 11     $ 12     $ 19     $ 21     $ 20     $ 16  

Research and development

    26       131       54       62       68       70       51  

Sales and marketing

    10       45       45       85       74       85       89  

General and administrative

    55       90       125       162       224       225       232  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $ 93     $ 277     $ 236     $ 328     $ 387     $ 400     $ 388  
 

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

 

(2)

Genomic testing volume represents the total number of genomic test results delivered to ordering physicians and pharmaceutical partners.

Quarterly Revenue Trends

Genomic testing revenue increased sequentially in each quarter throughout 2019 and 2020. We had no material genomic testing revenue from pharmaceutical partners during the first nine months of 2019, but recognized $2.0 million of revenue from pharmaceutical partners in the fourth quarter of 2019 due to the processing and completion of a large retrospective cohort study. Genomic testing revenue increased from the first quarter of 2019 to the second quarter of 2019 primarily due to an increase in our Medicare revenue of $1.2

 

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million and an increase in our commercial payor revenue of $0.7 million. Genomic testing revenue increased from the second quarter of 2019 to the third quarter of 2019 primarily due to our receipt of Medicare coverage for our first two Decipher Biopsy products in May 2019 covering the Low and Very Low indications and an increase in our Medicare reimbursement of approximately 14%, effective June 1, 2019, across covered Decipher Biopsy and Decipher RP tests. The increase in revenue from the second quarter of 2019 to the third quarter of 2019 was related to higher overall revenue from commercial payors offset by a decrease in our Medicare revenue associated with lower Medicare genomic testing volumes. Genomic testing revenue increased from the fourth quarter of 2019 to the first quarter of 2020 primarily due to our receipt of Medicare coverage for our Decipher Biopsy products covering Favorable Intermediate and an increase in volume associated with the launch of our Unfavorable Intermediate indication. The increase sequentially from the first quarter of 2020 to the third quarter of 2020 is due to an increase in our commercial and patient cash collections, better payments from commercial payors due to a higher number of covered commercial lives, and higher overall Medicare volumes associated with the expansion of our commercial sales organization.

Other revenue decreased sequentially in each quarter throughout 2019 and 2020 as a result of reduced commissions paid to us by a third-party company utilizing our commercial sales force to sell their complementary product in physician offices, in connection with our termination of the related agreement in May 2019.

Quarterly Costs and Operating Expense Trends

Cost of revenue decreased sequentially in each quarter throughout the first three quarters of 2019. The decrease from the first quarter of 2019 to the second quarter of 2019 was primarily due to bringing our pathology function in-house and the renegotiation of pricing included in our supply agreement with Affymetrix. The decrease from the second quarter of 2019 to the third quarter of 2019 was primarily related to a decrease in our genomic testing volume. The increase from the third quarter of 2019 to the fourth quarter of 2019 was primarily related to an increase in our genomic testing volume. Cost of revenue increased from the fourth quarter of 2019 to the first quarter of 2020 due to the launch of our Decipher Biopsy Unfavorable Intermediate indication. The decrease from the first quarter of 2020 to the second quarter of 2020 primarily related to a decrease in our genomic testing volume due to the COVID-19 pandemic and the decrease in physician office visits by patients. The increase from the second quarter of 2020 to the third quarter of 2020 was primarily due to an increase in our genomic testing volume due to the loosening of lockdown restrictions related to the COVID-19 pandemic.

Research and development expenses in 2019 and 2020 fluctuated primarily based on the number of samples we processed and the timing of expenditures incurred in support of the clinical studies conducted by our academic collaborators.

Sales and marketing expense increased sequentially during 2019 and the first quarter of 2020 as we initiated our sales expansion strategy and expanded our business development function. The decrease from the first quarter of 2020 to the third quarter of 2020 was primarily due to a decrease in travel and related expenses due to the COVID-19 pandemic and lockdown restrictions.

General and administrative expense remained relatively consistent throughout 2019 and 2020 as we maintained a relatively consistent structure and administrative headcount during these periods. In the fourth quarter of 2019, our general and administrative expenses increased $0.2 million related to higher audit and tax fees.

Seasonality

The majority of our testing volume is dependent on patient visits to physicians’ offices. Volume of testing generally declines during the summer months of July and August and the year-end holiday periods and other major holidays. In addition, volume of testing tends to decline due to adverse weather conditions, such as

 

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excessively hot or cold spells or hurricanes or tornados in certain regions, consequently reducing revenue and cash flows in any affected period. Therefore, comparison of the results of successive periods may not accurately reflect trends for successive periods.

Liquidity and Capital Resources

Prior to the quarter ended September 30, 2020, we had incurred net losses in each quarter since our inception. For the years ended December 31, 2018 and 2019 and the nine months ended September 30, 2020, we incurred a net loss of $29.9 million, $18.5 million and $3.4 million, respectively. Although we may have periods of operating income, we expect to continue to incur significant expenses for the foreseeable future and to incur operating losses in the near term while we make investments to support our anticipated growth. As of September 30, 2020, we had an accumulated deficit of $65.2 million.

As of September 30, 2020, we have been financed primarily through net proceeds of approximately $175.4 million from the sale of our equity securities, convertible promissory notes and borrowings under the Loan Agreement. Our primary source of cash from operations is cash receipts on accounts receivable from our revenue. As of September 30, 2020, we had $14.5 million of cash.

Our primary uses of cash are to fund operating expenses, service debt and acquire property and equipment. Cash used to fund operating expenses excludes the impact of non-cash items such as depreciation, non-cash interest and stock-based compensation and is impacted by the timing of when we pay our operating expenses as reflected in the change in our outstanding accounts payable and accrued expenses. Debt service primarily consists of interest payments on our outstanding debt and is expected to be reduced when we repay a portion of our outstanding long-term debt with the net proceeds from this offering. Acquisitions of property and equipment primarily consist of purchases of furnishings for our new corporate headquarters and laboratory equipment.

Pursuant to the Loan Agreement, we borrowed an aggregate of $32.0 million during 2015, 2016, 2019 and 2020 that accrues interest at 13.0% per annum, payable on a quarterly basis. If we are not in default, we may defer up to 5.0% per annum of the interest payment, which will be added to the principal balance. We can prepay borrowings under the Loan Agreement at any time, currently subject to a prepayment fee of up to 5.0%. Upon maturity on June 30, 2021, all outstanding principal and deferred interest, and a 12.0% back-end fee on the aggregate principal amount under the Loan Agreement, is due and payable. As of September 30, 2020, we had outstanding principal of $32.0 million under the Loan Agreement, deferred interest of $5.7 million and accreted $2.8 million associated with the 12.0% back-end fee. As of September 30, 2020, $5.0 million of credit remains available under the Loan Agreement through March 2021. The maturity date will be extended by six months to December 2021 in the event of a qualified IPO as defined in the Loan Agreement.

The Loan Agreement contains customary events of default, including in the event of bankruptcy or upon the occurrence of a material adverse change in our business. Our obligations under the Loan Agreement are collateralized by all of our assets. The Loan Agreement includes affirmative and negative covenants, including certain minimum financial covenants for pre-specified liquidity and revenue requirements. If we fail to comply with the minimum annual revenue covenant, we have the option to cure such failure within a certain time period by raising capital through certain debt or equity financings. If we are unable to cure a failure to meet an annual revenue target, the failure would be considered an event of default. In addition, we are restricted from paying cash dividends. We intend to use a portion of the net proceeds from this offering to repay, prior to the contractual maturity date, a portion of the aggregate principal amount outstanding under the Loan Agreement, and to pay accrued interest on such outstanding principal amount as well as related back-end and loan prepayment fees (for additional details, see the section titled “Use of Proceeds”).

 

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Funding Requirements

Based on our current business plan, we estimate that the net proceeds from this offering, together with our current cash and cash equivalents and our anticipated cash flows generated from sales of our products, will be sufficient to meet our anticipated cash requirements over at least the next                months from the date of this prospectus. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As a result of our expected revenue growth, we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not fully cover corresponding increases in accounts payable and accrued expenses, which could result in greater working capital requirements. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

Until such time, if ever, as we can generate revenue to support our cost structure, we expect to finance our operations through equity offerings or debt financings, or other capital resources, including potentially collaborations or licensing arrangements. The sale of equity and convertible debt securities may result in dilution to our stockholders and the terms of these securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available on reasonable terms, or at all. Management has prepared cash flow forecasts which indicate that based on our expected cash flows and timing of maturity of our long-term debt, but without taking into account the net proceeds from this offering, there is substantial doubt about our ability to continue as a going concern for twelve months after the date our unaudited condensed consolidated financial statements were issued.

Our ability to generate sufficient revenue to achieve profitability will be heavily dependent on the successful commercialization of our currently marketed products and our anticipated future products, as well as obtaining favorable reimbursement. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on the commercialization of our existing products and the development of future products.

Our operating results may fluctuate significantly from period to period, depending on the timing of our planned development activities, clinical studies, and the growth of our sales and marketing activities. We expect our expenses will increase substantially for the foreseeable future as we:

 

   

attract, hire and retain qualified personnel;

 

   

continue to develop additional products, expand Decipher GRID and conduct or support our ongoing and new clinical studies to generate the evidence required to support expanded reimbursement of our products;

 

   

expand our sales force and territories and increase our marketing activities to drive further awareness and adoption of our products;

 

   

protect and defend our intellectual property;

 

   

invest in processes, infrastructure to support the growth of our business; and

 

   

operate as a public company.

 

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Cash Flows

The following table summarizes our cash flow activity for the periods indicated.

 

     Year Ended
December 31,
    Nine Months Ended
September 30,
 
     2018     2019     2019     2020  
     (in thousands)  

Net cash provided by (used in):

        

Operating activities

   $ (20,846   $ (21,435   $ (15,746   $ 1,368  

Investing activities

     —         (632     (196     (488

Financing activities

     23,163       22,479       17,589       9,125  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net increase in cash

   $ 2,317     $ 412     $ 1,647     $ 10,005  
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating Activities

Cash used in operating activities was $15.7 million for the nine months ended September 30, 2019 compared to net cash provided by operating activities of $1.4 million for the nine months ended September 30, 2020. Cash used in operating activities for the nine months ended September 30, 2019 consisted primarily of our net loss of $14.8 million, adjusted for non-cash charges of $3.9 million and $4.9 million of changes in operating assets and liabilities. Non-cash charges consisted primarily of non-cash interest expense and settlement charges related to our Loan Agreement and convertible promissory notes, depreciation and amortization, amortization of right-of-use assets, stock-based compensation expense and the revaluation of warrants and embedded derivative liabilities. Changes in operating assets and liabilities consisted primarily of the pay down of our accounts payable, accrued liabilities and lease liabilities, and growth in supplies inventory, offset by a decrease in accounts receivable.

Cash provided by operating activities for the nine months ended September 30, 2020 consisted primarily of our net loss of $3.4 million, adjusted for non-cash charges of $4.5 million and $0.2 million of changes in operating assets and liabilities. Non-cash charges consisted primarily of non-cash interest expense related to our Loan Agreement, depreciation and amortization, amortization of our right-of-use assets and stock-based compensation expense.

Cash used in operating activities was $20.8 million for the year ended December 31, 2018 compared to $21.4 million for the year ended December 31, 2019. Cash used in operating activities for the year ended December 31, 2018 consisted primarily of our net loss of $29.9 million, adjusted for non-cash charges of $5.5 million and $3.6 million of changes in operating assets and liabilities. Non-cash charges consisted primarily of non-cash interest expense and settlement charges related to our Loan Agreement and convertible promissory notes, depreciation and amortization, stock-based compensation expense and the revaluation of warrants and embedded derivative liabilities. Changes in operating assets and liabilities consisted primarily of growth in accrued liabilities and accounts receivable, offset by decreases in income tax receivable and supplies inventory and prepaid and other assets. Cash used in operating activities for the year ended December 31, 2019 consisted primarily of our net loss of $18.5 million, adjusted for non-cash charges of $5.1 million and $8.1 million of changes in operating assets and liabilities. Non-cash charges consisted primarily of non-cash interest expense and settlement charges related to our Loan Agreement and convertible promissory notes, depreciation and amortization, amortization of our right-of-use assets, stock-based compensation expense and the revaluation of warrants and embedded derivative liabilities. Changes in operating assets and liabilities consisted primarily of a reduction in accounts payable and accrued liabilities as a result of payment of legal settlement obligations and carrying lower overall payable balances with major suppliers, growth in accounts receivable and inventory balances and lease liability obligations.

 

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Investing Activities

Cash used in investing activities was $0.2 million and $0.5 million for the nine months ended September 30, 2019 and 2020 and consisted primarily of laboratory equipment purchases. Cash used in investing activities was $0.6 million for the year ended December 31, 2019 and consisted primarily of laboratory equipment and office furniture purchases for our new corporate headquarters. We had no cash flows used in investing activities in 2018.

Financing Activities

Cash provided by financing activities was $17.6 million for the nine months ended September 30, 2019 compared to $9.1 million for the nine months ended September 30, 2020. The $8.5 million decrease in cash provided by financing activities was primarily due to our receipt of $5.4 million less in net proceeds from the sale of redeemable convertible preferred stock during the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019 and our receipt of $0.9 million less in net proceeds from the issuance of debt during the nine months ended September 30, 2020 compared to the nine months ended September 30, 2019. In addition, we paid $2.2 million in initial public offering costs during the nine months ended September 30, 2020, while no such costs were paid during 2019.

Cash provided by financing activities was $23.2 million for the year ended December 31, 2018 compared to $22.5 million for the year ended December 31, 2019. The $0.7 million decrease in cash provided by financing activities was primarily due to our receipt of $1.4 million less in net proceeds from the sale of redeemable convertible preferred stock in 2019 compared to 2018 and our receipt of $0.7 million more in net proceeds from the issuance of debt in 2019 compared to 2018.

Contractual Obligations and Commitments

The following table summarizes our contractual obligations and commitments as of December 31, 2019.

 

     Payments Due by Period(1)  
     Total      Less than
1 Year
     1-3 Years      3-5 Years      More than
5 Years
 
     (in thousands)  

Long-term debt – related party, including interest and back-end fee(2)

   $ 44,954      $ 2,848      $ 42,106      $ —        $ —    

Operating lease obligations

     7,956        1,193        2,622        2,720        1,421  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 52,910      $ 4,041      $ 44,728      $ 2,720      $ 1,421  
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

 

(1)

Excludes trade account payables and purchase orders arising in the ordinary course of business.

(2)

Excludes $2.0 million borrowed in March 2020 under our Loan Agreement.

The contractual obligations table does not include any additional potential contingent payments upon the future achievement by us of specified sales-based and other milestones, or royalty payments we may be required to make under license agreements we have entered into pursuant to which we have in-licensed certain intellectual property, including our license agreements with The Regents of the University of Michigan, the Mayo Foundation, and the University of British Columbia. See the section titled “Business—License Agreements” and Note 4 to our audited consolidated financial statements included elsewhere in this prospectus for additional information. The timing of when these additional payments will actually be made is uncertain and the payments are contingent upon the completion of future activities.

JOBS Act

As an emerging growth company under the JOBS Act, we can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the

 

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adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to avail ourselves of this exemption and, therefore, we may not be subject to the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies, which may make comparison of our financials to those of other public companies more difficult. We intend to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.

We will remain an emerging growth company until the earliest of (i) the last day of the fiscal year following the fifth anniversary of the consummation of this offering, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.07 billion, (iii) the last day of the fiscal year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year, or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.

Off-Balance Sheet Arrangements

During the periods presented we did not have, nor do we currently have, any off-balance sheet arrangements as defined under SEC rules.

Quantitative and Qualitative Disclosures About Market Risk

Interest Rate Risk

Our cash consists of cash in readily available checking accounts and money market accounts. As a result, the fair value of our portfolio is relatively insensitive to interest rate changes. Our long-term debt bears interest at a fixed rate and therefore has no exposure to changes in interest rates.

Foreign Currency

All of our international sales are denominated in U.S. dollars. We incur expenses, including for operating expenses of our Canadian branch, outside the United States based on contractual obligations denominated in currencies other than the U.S. dollar, including Canadian dollars. At the end of each reporting period, these liabilities are converted to U.S. dollars at the then-applicable foreign exchange rate. As a result, our business is affected by fluctuations in exchange rates between the U.S. dollar and foreign currencies. We do not enter into foreign currency hedging transactions to mitigate our exposure to foreign currency exchange risks. Exchange rate fluctuations may adversely affect our expenses, results of operations, financial position and cash flows. However, to date, these fluctuations have not been significant and a movement of 10% in U.S. dollar to the Canadian dollar exchange rate would not have a material effect on our results of operations.

Effects of Inflation

Inflation generally affects us by increasing our labor and other operating costs. We do not believe inflation has had a material effect on our results of operations during the periods presented.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are

 

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based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions and any such differences may be material. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Revenue Recognition

The following paragraphs in this section describe our revenue recognition accounting policies under ASC Topic 606 upon adoption on January 1, 2019. Upon adoption, we recognized the cumulative effect of adopting this guidance as an adjustment to our opening accumulated deficit balance of $0.7 million. Refer to Note 1 included in the notes to our audited consolidated financial statements for our revenue recognition accounting policies under ASC Topic 605.

Revenue is recognized when control of the promised goods or services is transferred to customers, in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. To determine revenue recognition for the arrangements that we determine are within the scope of ASC Topic 606, we perform the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The estimated uncollectible amounts that were historically classified as bad debt expense are now generally considered implicit price concessions that are a direct reduction to accounts receivable rather than an increase in allowance for doubtful accounts.

Our revenue is primarily derived from the sale of our genomic testing products. Our performance obligations are satisfied at one point in time, when test results are delivered. We estimate the amount of consideration we expect to be entitled to receive in exchange for our genomic testing products based on our historical collection experience. We regularly review and update these price estimates to more accurately estimate the transaction price at the end of each period. If subsequent events impact the original estimate we will account for the change in the estimate in the period identified. We also provide services to patients with whom we do not have contracts as defined in Topic 606. We recognize revenue for these patients when contracts as defined in Topic 606 are established at the amount of consideration to which we expect to be entitled or when we receive substantially all of the consideration subsequent to the performance obligations being satisfied.

Stock-Based Compensation

Stock-based compensation expense represents the cost of the grant date fair value of equity awards recognized over the requisite service period of the awards (generally the vesting period) on a straight-line basis. We estimate the fair value of all stock option grants using the Black-Scholes option pricing model and recognize forfeitures as they occur. The significant assumptions used in the option pricing model include the risk-free interest rate, the expected stock price volatility, the expected term of stock options, the expected dividend yield and the fair value of the underlying common stock on the date of grant. These inputs are subjective and generally require significant analysis and judgment to develop. See Note 6 to our audited consolidated financial statements and unaudited condensed consolidated financial statement included elsewhere in this prospectus for additional information concerning certain of the specific assumptions we used in applying the Black-Scholes option pricing model to determine the estimated fair value of our stock options granted in the years ended December 31, 2018 and 2019 and the nine months ended September 30, 2019 and 2020. Changes in these assumptions can materially affect the fair value and ultimately how much stock-based compensation expense is recognized.

As of September 30, 2020, the unrecognized stock-based compensation expense related to stock options was $3.3 million and is expected to be recognized as expense over a weighted-average period of approximately 2.7

 

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years. The intrinsic value of all outstanding stock options as of September 30, 2020 was approximately $            million, based on the assumed initial public offering price of $            per share, which is the midpoint of the price range set forth on the cover page of this prospectus, of which approximately $            million related to vested options and approximately $            million related to unvested options.

Common Stock Valuations

Historically, for all periods prior to this offering, since there has been no public market for our common stock to date, we have been required to estimate the fair value of the common stock underlying our stock-based awards when performing fair value calculations, which is the most subjective input into the Black-Scholes option pricing model. The fair value of the common stock underlying our stock-based awards was determined on each grant date by our board of directors, taking into account input from management and independent third-party valuation analyses. All options to purchase shares of our common stock are intended to be granted with an exercise price per share no less than the fair value per share of our common stock underlying those options on the date of grant, based on the information known to us on the date of grant. Our determinations of the fair value of our common stock were made using methodologies, approaches and assumptions consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide: Valuation of Privately Held Company Equity Securities Issued as Compensation, or the Practice Aid.

Our board of directors considered various objective and subjective factors, along with input from management, to determine the fair value of our common stock, including:

 

   

contemporaneous valuations of our common stock performed by independent third-party valuation firms;

 

   

our current and forecasted results of operations and financial position, including our levels of available capital resources;

 

   

the valuation of publicly traded companies in the diagnostics and medical device sectors, as well as recently completed mergers and acquisitions of peer companies;

 

   

the lack of marketability of our common stock as a private company;

 

   

the prices of our redeemable convertible preferred stock sold to investors in arm’s length transactions and the rights, preferences and privileges of our redeemable convertible preferred stock relative to those of our common stock;

 

   

the likelihood of achieving a liquidity event for the holders of our common stock, such as an initial public offering or a sale of our company, given prevailing market conditions;

 

   

trends and developments in our industry; and

 

   

external market conditions affecting the diagnostics and medical device sectors.

The Practice Aid prescribes several valuation approaches for setting the value of an enterprise, such as the cost, income and market approaches, and various methodologies for allocating the value of an enterprise to its common stock. The cost approach establishes the value of an enterprise based on the cost of reproducing or replacing the property less depreciation and functional or economic obsolescence, if present. The income approach establishes the value of an enterprise based on the present value of future cash flows that are reasonably reflective of our future operations, discounting to the present value with an appropriate risk adjusted discount rate or capitalization rate. The market approach is based on the assumption that the value of an asset is equal to the value of a substitute asset with the same characteristics. Each valuation methodology was considered in our valuations.

 

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The various methods for allocating the enterprise value across our classes and series of capital stock to determine the fair value of our common stock in accordance with the Practice Aid include the following:

Current Value Method. Under the current value method, once the fair value of the enterprise is established, the value is allocated to the various series of preferred and common stock based on their respective seniority, liquidation preferences or conversion values, whichever is greatest.

Option Pricing Method, or OPM. Under the OPM, shares are valued by creating a series of call options with exercise prices based on the liquidation preferences and conversion terms of each equity class. The values of the preferred and common stock are inferred by analyzing these options.

Probability-Weighted Expected Return Method, or PWERM. The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes available to us, as well as the economic and control rights of each share class.

Prior to October 2019, we concluded that the OPM was most appropriate for each of the valuations of our common stock performed by independent third-party valuation firms. We believed the OPM was the most appropriate given the expectation of various potential liquidity outcomes and the difficulty of selecting and supporting appropriate enterprise values given our early stage of commercialization. In October 2019, and for our subsequent valuations during 2020, we concluded a hybrid OPM and PWERM was the most appropriate method given the increased probability of an IPO liquidity scenario. Under this hybrid method, we considered the expected IPO liquidity scenario, but also used the OPM to capture all other scenarios in the event a near-term initial public offering does not occur.

There are significant judgments and estimates inherent in the determination of the fair value of our common stock. These judgments and estimates include assumptions regarding our future operating performance, the time to complete an initial public offering or other liquidity event and the determination of the appropriate valuation methods. If we had made different assumptions, our stock-based compensation expense, net loss and net loss per share of common stock could have been significantly different.

Following the completion of this offering, the fair value of our common stock will be based on the closing price as reported on the date of grant on the primary stock exchange on which our common stock is traded.

Recently Adopted and Recent Accounting Pronouncements

See Note 1 to our audited consolidated financial statements and unaudited condensed consolidated financial statements included elsewhere in this prospectus for information about recent account pronouncements, the timing of their adoption, and our assessment, if any, of their potential impact on our financial condition and results of operations.

 

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BUSINESS

Overview

We are a commercial-stage precision oncology company committed to improving patient care, with a focus in urologic oncology specific to prostate and bladder cancers. Our novel prostate cancer genomic testing products, Decipher Biopsy and Decipher RP, provide valuable information about the underlying biology of a patient’s tumor, assisting physicians in their selection of an optimal therapy. Our differentiated approach measures the biological activity of a patient’s entire tumor genome, known as whole transcriptome analysis, and applies proprietary machine learning algorithms to help physicians improve therapy selection and accelerate adoption of new therapies into the standard of care. Collectively, our genomic tests have been used by more than 3,200 urologists and radiation oncologists, and at all 28 National Comprehensive Cancer Network, or NCCN, centers in the United States. Our prostate cancer products are covered by Medicare in nine clinical indications, representing the entire known spectrum of localized, regional, and biochemically recurrent prostate cancer. Six of our clinical indications received Medicare coverage in 2020. Our whole transcriptome analysis of clinical patient samples from our commercial channel and our participation in practice-changing clinical trials has allowed us to build and expand our Decipher GRID database, one of the largest and well-annotated urologic cancer genomic databases in the world. Decipher GRID is our proprietary engine that drives product development for us and our pharmaceutical partners.

Within the urologic cancer space, we are initially focused on prostate cancer, the most common cancer in men, with approximately 192,000 new cases per year and over 3.1 million men living with the disease in the United States alone. Approximately 92% of new cases of prostate cancer are diagnosed as localized disease and approximately 8% of new cases are diagnosed as metastatic disease. Depending on the diagnosis, prostate cancer therapies include surgery, radiation therapy, hormonal therapy, chemotherapy and other targeted therapies, which all have varying side effect profiles and efficacy based on the unique characteristics of a patient and the stage of his disease. Once a patient is initially diagnosed with localized prostate cancer, in order to determine the appropriate patient management and therapy strategy, patients are stratified by their clinical risk with the goal of predicting the patient’s risk of metastasis and prostate cancer-related mortality. However, accurate risk stratification remains a critical unmet medical need in the management of prostate cancer, with current risk stratification methods generally being from 60% to 68% accurate in predicting metastasis. This low accuracy has resulted in patients being overtreated or undertreated, which in each case, has led to suboptimal care management strategies and deleterious outcomes for many patients.

Decipher Biopsy and Decipher RP report a score derived from our whole transcriptome analysis that provides patient risk estimates of prostate cancer-specific clinical outcomes. Both tests have repeatedly demonstrated superior accuracy to the most commonly used clinical risk stratification methods, such as NCCN risk groups. For example, in our primary clinical validation study involving over 6,900 patients, Decipher Biopsy, in combination with NCCN risk groups, demonstrated an 84% accuracy rate for predicting metastasis, compared to 68% for NCCN risk groups alone. Additionally, the reported Decipher Score is independent of clinical risk stratification methods. The addition of Decipher testing can help guide urologists, radiation oncologists, medical oncologists and pathologists to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes. Recently for example, Decipher RP was studied in a Phase 3 randomized controlled trial, RTOG 96-01, where the Decipher Score became the first known test to be clinically validated for predicting distant metastases (p=0.003), prostate cancer-specific mortality (p<0.001), and overall survival (p=0.002) from localized prostate cancer in the clinical trial. The strength of the clinical data supporting the use of the Decipher Score has led to Decipher’s inclusion in national guidelines. For example, in the 2020 NCCN Clinical Practice Guidelines for Prostate Cancer, the Decipher test is “recommended” for use to improve therapy decision making. Decipher is the only molecular diagnostic test that is currently recommended for use in patients with localized prostate cancer in the NCCN guidelines. We estimate our therapy-directing genomic tests have a potential aggregate market opportunity of approximately $2.0 billion across urologic cancers.

 

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Our ability to capture and store the whole transcriptome profile from every patient sample (for Decipher Prostate and Decipher Bladder) combined with our participation in practice-changing prostate and bladder clinical trials has allowed us to build and expand our Decipher GRID database. By collecting and comparing transcriptomes of different types of cells or tissues, we believe that researchers can gain a deeper understanding of what constitutes a specific cell type and how changes in transcriptional activity may reflect or contribute to disease.

Our Decipher GRID genomic database contains over 90,000 urologic cancer transcriptomes matched to patient demographics and includes clinical trial outcome data.