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): January 4, 2018

HTG Molecular Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-37369	86-0912294
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)
3430 E. Global Loop Tucson, AZ		85706
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (877) 289-2615

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

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

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

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

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

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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 13(a) of the Exchange Act. ☒

Item 2.02 Results of Operations and Financial Condition.

On January 4, 2018, HTG Molecular Diagnostics, Inc. (the “Company”) issued a press release announcing certain preliminary financial results as of and for the fourth quarter and full year ended December 31, 2017. A copy of this press release is attached to this report as Exhibit 99.1. The information in this Item 2.02 and the attached exhibit are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.

Item 8.01 Other Events.

Although the Company’s financial results as of and for the fourth quarter and full year ended December 31, 2017 are not yet finalized, based on currently available information, the Company expects its fourth quarter 2017 revenue to be between $6.9 and $7.2 million, its full year 2017 revenue to be between $13.8 and $14.1 million and its cash and cash equivalents as of December 31, 2017 to be approximately $10.0 million. Fourth quarter and full year 2017 revenues were driven by collaboration revenue. Operating expenses for the fourth quarter are expected to be slightly higher than operating expenses in the third quarter of 2017 on an absolute dollar basis.  Gross margin and net loss for the fourth quarter of 2017 are expected to be improved over the third quarter of 2017, primarily as a result of collaboration profit-sharing revenue expected to be recognized in the fourth quarter.

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the quarter and year ended December 31, 2017 and are subject to revision based upon the Company’s year-end closing procedures and the completion and external audit of the Company’s year-end financial statements. The Company’s independent registered public accounting firm has not audited, reviewed, compiled or performed any procedures with respect to these preliminary financial results. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2017, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

Forward Looking Statements

Statements contained in this report regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s revenue expectations, including collaboration profit-sharing revenue expected to be recognized in the fourth quarter of 2017, and other expected financial results as of and for the fourth quarter and year ended December 31, 2017. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the risk that the Company’s actual revenue or other financial results for the fourth quarter and/or full year 2017, including collaboration profit-sharing revenue, may differ materially from the Company’s estimated results for these periods as a result of the completion of year-end closing procedures, final adjustments, final profit-sharing reconciliation with QIAGEN Manchester Limited (“Qiagen”) under the Company’s Master Assay Development, Commercialization and Manufacturing Agreement with Qiagen dated November 16, 2016, or other developments arising between now and the time that the Company’s financial results are finalized. These and other factors are described in greater detail in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. All forward-looking statements contained in this report speak only as of the date on which they were made, and the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Item 9.01 Results of Operations and Financial Condition.

(d) Exhibits

Exhibit No.	Description
99.1	Press release of HTG Molecular Diagnostics, Inc. dated January 4, 2018

SIGNATURES

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

	HTG Molecular Diagnostics, Inc.
Dated: January 4, 2018	By:	/s/Shaun D. McMeans
		Shaun D. McMeans
		Vice President of Finance and Administration and Chief Financial Officer

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

HTG Announces Preliminary Fourth Quarter and Full Year 2017 Unaudited Financial Results

and Provides Initial 2018 Revenue Guidance

Fourth quarter 2017 revenue expected to be between $6.9 and $7.2 million

Full year 2017 revenue expected to be between $13.8 and $14.1 million

Initial full year 2018 revenue guidance of $20.0 to $25.0 million

TUCSON, Ariz., January 4, 2018 --HTG Molecular Diagnostics, Inc. (NASDAQ: HTGM) (HTG), a provider of instruments, reagents and services for molecular profiling applications, today announced preliminary and unaudited financial results for the fourth quarter and full year ended December 31, 2017, and provided initial full year 2018 revenue guidance.

Preliminary 4th Quarter and Full Year 2017 Unaudited Financial Results and Revenue Guidance for 2018:

• Total revenue for the fourth quarter of 2017 is expected to be between $6.9 and $7.2 million, an increase of 373% to 394% over the fourth quarter of 2016.

• Total revenue for the full year 2017 is expected to be between $13.8 and $14.1 million, an increase of 169% to 175% over total revenue for the full year 2016.

• Collaboration revenue drove fourth quarter and full year 2017 revenue. Operating expenses for the fourth quarter are expected to be slightly higher than operating expenses in the third quarter of 2017 on an absolute dollar basis. Gross margin and net loss in the fourth quarter are expected to be improved over the third quarter of 2017, primarily as a result of collaboration profit-sharing revenue expected to be recognized in the fourth quarter.

• Cash and cash equivalents are expected to be approximately $10.0 million as of December 31, 2017.

• HTG is providing initial revenue guidance for the year ending December 31, 2018 in the range of $20.0 to $25.0 million.

“Our strategy of developing high value diagnostic tests through our collaborations with Qiagen and top-tier biopharmaceutical companies is a primary reason for the strong revenue growth we saw in 2017, and helped propel us to a strong year end,” said TJ Johnson, President and CEO of HTG. “We expect this momentum to continue and believe our clinical and pre‑clinical collaborations, along with our independent development programs, will support continued revenue growth in 2018.”

The preliminary results set forth above are based on management's initial review of the Company’s operations for the quarter and year ended December 31, 2017 and are subject to revision based upon the Company’s year-end closing procedures and the completion and external audit of the Company’s year-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of year-end closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the fourth quarter or full year ended December 31, 2017, should not be viewed as a substitute for full, audited financial statements prepared in accordance with

generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period. The Company expects to announce full 2017 financial results in advance of its quarterly conference call, currently planned for Thursday, March 22, 2018.

About HTG:

Headquartered in Tucson, Arizona, the mission of HTG is to empower precision medicine at the local level. The company’s HTG EdgeSeq technology, which automates highly multiplexed molecular profiling of small samples for next-generation sequencing, received its first US patent in 2014. Continuous improvements led to the 2017 launch of HTG’s new direct-target sequencing chemistry for DNA analysis offered in the company’s VERI/O services laboratory. Additional information is available at www.htgmolecular.com

Safe Harbor Statement:

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our revenue expectations, including collaboration profit-sharing revenue expected to be recognized in the fourth quarter of 2017, and other expected financial results as of and for the fourth quarter and year ended December 31, 2017, our initial revenue guidance for the year ending December 31, 2018 and the expected benefits of our collaborations to our future revenues. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, the risk that we may not realize the benefits expected under our collaboration agreements with Qiagen or other biopharmaceutical companies; the risk that our actual revenue or other financial results for the fourth quarter and/or full year 2017, including collaboration profit-sharing revenue, may differ materially from our estimated results for these periods as a result of the completion of year-end closing procedures, final adjustments, final profit-sharing reconciliation with Qiagen, or other developments arising between now and the time that our financial results are finalized; the risk that we may not achieve our revenue expectations for 2018 (including, without limitation, due to variations from our expectations in the amount or timing of work we perform under one or more companion diagnostic development programs with large pharma customers, which development programs comprise an increasing portion of our business and therefore have the ability to significantly impact the timing and amount of revenue recognized in one or more fiscal periods); risks associated with our ability to successfully commercialize our products; the risk that our products and services may not be adopted by biopharmaceutical companies or other customers as anticipated, or at all; our ability to manufacture our products to meet demand; the level and availability of first party payor reimbursement for our products; our ability to effectively manage our anticipated growth; our ability to protect our intellectual property rights and proprietary technologies; our ability to operate our business without infringing the intellectual property rights and proprietary technology of first parties; competition in our industry; our ability to attract and retain qualified personnel; and product liability claims. These and other factors are described in greater detail in our filings with the Securities and Exchange Commission, including without limitation our Quarterly Report on Form 10-Q for the quarter ended September 30, 2017. All forward-looking statements contained in this press release speak only as of the date on which they were made, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact:

LifeSci Advisors, LLC

Ashley Robinson

Phone: (617) 775-5956

Email: arr@lifesciadvisors.com

TJ Johnson
President / CEO
HTG Molecular Diagnostics
Phone: (520) 547-2827 x130
Email: tjjohnson@htgmolecular.com