0001104659-15-059088.txt : 20150812 0001104659-15-059088.hdr.sgml : 20150812 20150812160927 ACCESSION NUMBER: 0001104659-15-059088 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20150812 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150812 DATE AS OF CHANGE: 20150812 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Natera, Inc. CENTRAL INDEX KEY: 0001604821 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 010894487 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37478 FILM NUMBER: 151047123 BUSINESS ADDRESS: STREET 1: 201 INDUSTRIAL ROAD STREET 2: SUITE 410 CITY: SAN CARLOS STATE: CA ZIP: 94070 BUSINESS PHONE: 650-249-9090 MAIL ADDRESS: STREET 1: 201 INDUSTRIAL ROAD STREET 2: SUITE 410 CITY: SAN CARLOS STATE: CA ZIP: 94070 8-K 1 a15-17427_18k.htm 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): August 12, 2015

 


 

Natera, Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware

 

001-37478

 

01-0894487

(State or other jurisdiction
of incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

201 Industrial Road, Suite 410

San Carlos, California 94070

(Address of principal executive offices, including zip code)

 

(650) 249-9090

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):

 

o     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02.     Results of Operations and Financial Condition.

 

On August 12, 2015, Natera, Inc. issued a press release announcing its results for its second quarter ended June 30, 2015. A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information in this Current Report on Form 8-K and the accompanying Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by reference in such filing.

 

Item 9.01.    Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

 

Description

99.1

 

Press Release dated August 12, 2015

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

Natera, Inc.

 

 

 

 

By:

/s/ Herm Rosenman

 

 

Herm Rosenman

 

 

Chief Financial Officer (Principal Financial and Accounting Officer)

 

Dated: August 12, 2015

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release dated August 12, 2015

 

4


EX-99.1 2 a15-17427_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Natera Reports Second Quarter 2015 Financial Results

 

SAN CARLOS, Calif., August 12, 2015 /PRNewswire/ - Natera, Inc. (NASDAQ: NTRA), a leader in non-invasive genetic testing and the analysis of circulating cell-free DNA, today reported financial results for the second quarter ended June 30, 2015 and provided an update on recent business progress.

 

Recent Accomplishments & Highlights

 

·                  Achieved Total Revenue of $45.1 million in the second quarter of 2015, an increase of 26% over the same period of the prior year.

·                  Accessioned roughly 69,000 tests in the second quarter of 2015 compared to roughly 54,000 tests accessioned in the second quarter of 2014, an increase of 28%.

·                  Completed a successful initial public offering, resulting in net proceeds to Natera of approximately $178.5 million, including $15.1 million from the exercise of the underwriters’ overallotment option.

·                  Expanded adoption of our Constellation cloud-based distribution model by executing a license agreement with GE Clarient focused on oncology.

·                  Selected for TRACERx Study of Lung Cancer Heterogeneity Using Cell-Free Tumor DNA, funded by Cancer Research UK. This study will use Natera’s therapeutic monitoring panel, as well as Natera’s minimum residual disease testing and recurrence monitoring panel.

·                  Announced publication of a new health economics study by Peter Benn, DSc., Professor of Genetics at the UCONN Health Center, that supports the use of non-invasive prenatal testing (NIPT) as a first line screening for chromosomal aneuploidies and related conditions.

·                  Launched an improved version of HorizonTM, Natera’s carrier screening panel, which screens for up to 274 conditions.

·                  Launched version 2 of Natera’s PanoramaTM non-invasive prenatal test, improving re-draw rates and performance at a lower fetal fraction than previously possible.

 

“We are pleased with our results in the quarter, particularly with the continued adoption of our cloud-based Constellation software,” said Matt Rabinowitz, Natera’s chief executive officer. “We continued to launch new products, add new commercial partners to our network, improve our customers’ user experience, and advance a broad range of clinical trials in both prenatal testing and oncology.”

 

Second Quarter and Six Months Ended June 30, 2015 Financial Results

 

Revenue was $45.1 million compared to $35.8 million for the second quarter of 2014, an increase of 26%, primarily due to increased sales of Panorama. Revenues from Panorama increased $7.5 million and revenues from all other products increased $1.8 million during the three months ended June 30, 2015 compared to the three months ended June 30, 2014. Revenue for the six months ended June 30, 2015 was $92.5 million compared to $63.1 million for the same period in 2014, an increase of 47%. The increase in revenues from 2014 to 2015 was primarily due to higher test volumes, particularly for Panorama.

 



 

Gross profit for the three months ended June 30, 2015 was $19.4 million, representing a 43% gross margin, compared to $16.8 million, representing a 47% gross margin in the same period of the prior year. * Gross profit for the six months ended June 30, 2015 was $41.9 million, representing a 45% gross margin, compared to $28.2 million, representing a 45% gross margin in the same period of the prior year.  Gross margins in the second quarter of 2015 declined versus the second quarter of 2014 primarily due to an increase in both the average cost per test and a reduction in revenue received per test. The increase in the average cost per test was related to higher volumes for Panorama Microdeletions panel which requires more material and labor costs. The reduction in revenue received per test was driven primarily by reduced average reimbursement for Panorama due to new CPT codes that went into effect in January 2015.  In addition, with the shift in focus to the direct sales model in the United States in late 2014, cost of product revenues in the second quarter of 2015 includes costs for tests performed in advance of related revenue recognition.  We now recognize revenue primarily on a cash received basis.

 

Total combined research and development and selling, general and administrative expenses for the three months ended June 30, 2015 were $34.8 million, an increase of 93% compared to $18.0 million in the same period of the prior year. Total combined research and development and selling, general and administrative expenses for the six months ended June 30, 2015 were $63.7 million, an increase of 74% compared to $36.7 million in the same period of the prior year.  The increase in both the three- and six-months ended June 30 over the prior year was driven by an increase in research and development and direct sales headcount. The increase over the prior year reflects the net addition of 218 employees and contractors from June 30, 2014 to June 30, 2015 as we increased our focus on a direct sales model in the United States. This significant investment in our direct ob/gyn-focused sales force in the United States is designed to capture significant market share for our full suite of women’s health products, including NIPT for all risk categories as reimbursement policies evolve.

 

Loss from operations for the second quarter of 2015 was $15.5 million compared to $1.2 million for the same period of the prior year. Loss from operations for the six months ended June 30, 2015 was $21.7 million compared to $8.5 million for the same period of the prior year.

 

For the three-months ended June 30, 2015, we reported a net loss of $19.7 million which includes non-cash expenses of approximately $3.0 million related to a change in the fair value of warrants and approximately $0.3 million related to a change in the fair value of long-term debt.  Without these adjustments, our net loss would be $16.4 million. For the six-months ended June 30, 2015, we reported a net loss of $29.7 million which includes non-cash expenses of $3.9 million related to a change in the fair value of warrants and $2.1 million related to a change in the fair value of long-term debt.  Without these adjustments, our net loss would be $23.7 million.

 

* Gross profit is calculated as GAAP total revenues less GAAP cost of product revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.

 

2015 and 2016 Financial Outlook

 

Natera anticipates 2015 revenues of $175 million to $190 million; 2015 cost of product revenues to be approximately 65% of revenues; selling, general and administrative costs to be approximately 60% of revenues; and research and development costs to be 15% to 18% of revenues. Revenues may be adversely affected by entering in-network contracts with certain payers, which has long term strategic benefits and which is expected to occur in the second half of the third quarter or in the fourth quarter of 2015. Natera anticipates revenues of $220 million to $240 million in 2016, assuming robust adoption and reimbursement of the Panorama test within the average risk population in 2016.

 



 

About Natera

 

Natera is a leading genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software system. Tests include the Spectrum™ pre-implantation genetic test for embryo selection during IVF; the Anora™ miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; and the Panorama™ non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation. Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration.

 

Conference Call Information

 

Event:

Natera’s Second Quarter 2015 Results Conference Call

 

 

Date:

Wednesday, August 12, 2015

 

 

Time:

1:30 p.m. PT (4:30 p.m. ET)

 

 

Live Dial-In:

(866) 864-2549, Domestic

 

 

 

(704) 908-0477, International

 

 

Webcast:

investor.natera.com

 

A webcast replay will be available at investor.natera.com.

 

Forward-Looking Statements

 

This release contains forward-looking statements, including statements regarding Natera’s products, commercial partners, user experience, clinical trials, preliminary future financial outlook and financial performance, strategies, and general business conditions. Any forward-looking statements contained in this release are based upon Natera’s current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future.

 

These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving the preliminary financial guidance provided; we may be unable to further increase the use and adoption of Panorama, through our

 



 

direct sales efforts or through our laboratory partners, or to develop and successfully introduce new products, including our cancer products; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; our quarterly results may fluctuate significantly; we may be unable to compete successfully with either existing or future prenatal testing products or other test methods; our cloud-based distribution model may be difficult to implement, and may not be successful in satisfying any necessary regulatory requirements, including the FDA’s draft guidances related to oversight of LDTs, if finalized; the results of our clinical studies may not support the use of our tests, particularly in the average-risk pregnancy population, or may not be able to be replicated in later studies required for regulatory approvals or clearances; if our sole laboratory facility becomes inoperable, we will be unable to perform our tests and our business will be harmed; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; the marketing, sale, and use of Panorama and our other products could result in substantial damages arising from product liability or professional liability claims that exceed our resources; we may be unable to expand third-party payer coverage and reimbursement for Panorama and our other tests if third-party payers withdraw coverage or provide lower levels of reimbursement due to changing policies, billing complexities or other factors, and we may be required to refund reimbursements already received; if the FDA were to begin actively regulating our tests as outlined in the FDA’s October 3, 2014 draft guidances, we could incur substantial costs and delays associated with trying to obtain premarket clearance or approval and incur costs associated with complying with post-market controls; and any failure to obtain, maintain, and enforce our intellectual property rights could impair our ability to protect our proprietary technology and our brand.

 

Additional risks and uncertainties that could affect Natera’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Natera’s final prospectus dated July 1, 2015. This is available on Natera’s website at www.natera.com under the Investor Relations section and on the SEC’s website at www.sec.gov. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time.

 



 

Natera, Inc.

 

Condensed Consolidated Statements of Operations

 

(Unaudited)

 

(In thousands, except per share data)

 

 

 

Three months ended

 

Six months ended

 

 

 

June 30,

 

June 30,

 

 

 

2015

 

2014

 

2015

 

2014

 

Revenues

 

 

 

 

 

 

 

 

 

Product revenues

 

$

44,519

 

$

35,736

 

$

91,418

 

$

62,945

 

Other revenues

 

568

 

100

 

1,104

 

186

 

Total revenues

 

45,087

 

35,836

 

92,522

 

63,131

 

Cost and expenses:

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

25,732

 

19,014

 

50,575

 

34,914

 

Research and development

 

6,741

 

4,122

 

12,371

 

8,420

 

Selling, general and administrative

 

28,086

 

13,905

 

51,325

 

28,284

 

Total costs and expenses

 

60,559

 

37,041

 

114,271

 

71,618

 

Loss from operations

 

(15,472

)

(1,205

)

(21,749

)

(8,487

)

Interest expense

 

(1,203

)

(936

)

(2,213

)

(1,745

)

Interest (expense) benefit from changes in the fair value of long term debt

 

(322

)

1,340

 

(2,122

)

534

 

Other income (expense), net

 

(2,684

)

287

 

(3,601

)

(432

)

Net loss

 

$

(19,681

)

$

(514

)

$

(29,685

)

$

(10,130

)

Net loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(3.58

)

$

(0.11

)

$

(5.50

)

$

(2.17

)

Shares used to compute net loss per share attributable to common stockholders:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

5,494

 

4,722

 

5,393

 

4,658

 

 



 

Natera, Inc.

 

Condensed Consolidated Balance Sheets

 

(Unaudited)

 

(In thousands, except par value)

 

 

 

June 30, 

 

December 31, 

 

 

 

2015

 

2014

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash

 

$

62,243

 

$

87,176

 

Restricted cash, current portion

 

145

 

503

 

Accounts receivable, net of allowance of $628 in 2015 and $527 in 2014

 

5,273

 

5,942

 

Inventory

 

14,633

 

11,542

 

Prepaid expenses and other current assets

 

3,537

 

1,314

 

Total current assets

 

85,831

 

106,477

 

Property and equipment, net

 

15,047

 

14,574

 

Restricted cash, long term portion

 

1,428

 

808

 

Other assets

 

4,446

 

1,764

 

Total assets

 

$

106,752

 

$

123,623

 

Liabilities, Preferred Stock, and Stockholders’ (Deficit) Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

8,949

 

$

8,867

 

Accrued compensation

 

7,011

 

5,980

 

Other accrued liabilities

 

14,024

 

10,341

 

Deferred revenue

 

34

 

112

 

Equipment loan, current portion

 

2,340

 

2,340

 

Warrants

 

6,157

 

2,232

 

Total current liabilities

 

38,515

 

29,872

 

Equipment loan, long term portion

 

2,340

 

3,510

 

Senior secured term loan

 

23,086

 

20,964

 

Total long-term liabilities

 

25,426

 

24,474

 

Total liabilities

 

63,941

 

54,346

 

Commitments and contingencies

 

 

 

 

 

Convertible preferred stock

 

240,585

 

240,612

 

Stockholders’ deficit:

 

 

 

 

 

Common stock

 

1

 

1

 

Additional paid in capital

 

11,719

 

8,664

 

Notes receivable from officers

 

 

(192

)

Accumulated deficit

 

(209,494

)

(179,808

)

Total stockholders’ deficit

 

(197,774

)

(171,335

)

Total liabilities, convertible preferred stock, and stockholders’ deficit

 

$

106,752

 

$

123,623

 

 



 

Contacts

Natera, Inc.

Herm Rosenman

hrosenman@natera.com

 

Michael Hromadik, 858-442-2215

mhromadik@natera.com