htgm-8k_20200513.htm

 

 

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

May 13, 2020

Date of Report (Date of earliest event reported)

 

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))

Securities registered pursuant to Section 12(b) of the Act:

 

 

 

 

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 par value per share

 

HTGM

 

The Nasdaq Stock Market LLC

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 May 13, 2020, HTG Molecular Diagnostics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2020. A copy of this press release is attached hereto 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 9.01 Financial Statements and Exhibits

(d) Exhibits

 

Exhibit

No.

 

Description

 

 

 

99.1

 

Press release of HTG Molecular Diagnostics, Inc. dated May 13, 2020

 

 


 

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: May 13, 2020

 

By:

 

/s/ Shaun D. McMeans

 

 

 

 

Shaun D. McMeans

 

 

 

 

SVP and Chief Financial Officer

 

 

htgm-ex991_6.htm

Exhibit 99.1

 

FOR IMMEDIATE RELEASE

 

HTG Molecular Diagnostics Reports First Quarter 2020 Results

 

Call scheduled for today, May 13, at 4:30pm ET

 

TUCSON, Ariz., May 13, 2020 -- HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company whose mission is to advance precision medicine, today reported its financial results for the first quarter ended March 31, 2020.

 

“With the COVID-19 pandemic impacting businesses globally, the first quarter of 2020 was unlike anything we would have anticipated. As work from home restrictions directly impacted our customers and their normal ordering patterns, we felt the immediate impact,” said John Lubniewski, President and CEO of HTG. “However, we have managed to take advantage of this time to leverage our teams, improve our processes, and accomplish detailed long-term planning all in preparation of emerging from this period as a stronger company. While we cannot be certain of the ultimate impact of the COVID-19 pandemic on us or our customers, we are optimistic that demand for our products and services will return.”

 

Mr. Lubniewski continued, “Our product development teams have made progress towards the key milestones that we had set for ourselves during the quarter. Our California and Arizona development teams continue to implement our development strategy and we are on track to deliver development milestones. While the pandemic has created some near-term uncertainty, we are very proud of how our employees have faced the challenges – with flexibility and a commitment to ensuring our long-term success. When our customers eventually return to a more normal work environment, we will be prepared to meet demand and for growth in our business.”

 

First Quarter 2020 Financial Highlights:

Total revenue for the first quarter ended March 31, 2020 was $2.2 million, compared with $3.2 million for the same period in 2019. The decrease in revenue is a result of the impact of the COVID-19 pandemic requiring the closure of customer facilities around the globe. These closures limited the company’s ability to deliver its products to customer facilities and created challenges for customers in preparing and shipping samples to the company for processing.

 

Product and product-related services revenue was $2.0 million, compared with $2.7 million for the same period in 2019. This decrease in direct revenue primarily reflects a decline in lower margin, subcontracted laboratory services revenue reflected in RUO sample processing revenue when compared with first quarter of 2019 revenue.

 

Collaborative development services revenue for the quarter ended March 31, 2020 was $0.2 million compared with $0.5 million for the same period in 2019. The decrease in collaborative development services revenue reflects a decrease in activity as partners approached key decision points in current active programs.

 

Net loss from operations for the first quarter ended March 31, 2020 was $5.4 million, compared with $5.3 million for the first quarter of 2019. Net loss per share was $(0.08) for the first quarter of 2020 compared with $(0.19) for the first quarter of 2019.

 

Cash, cash equivalents and short-term available-for-sale securities totaled $32.0 million as of March 31, 2020, with current liabilities of approximately $8.4 million and non-current liabilities of $11.6 million. An additional $3.3 million of restricted cash was held in connection with a convertible note that is included in current liabilities as of March 31, 2020.  

 


 

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details are as follows:

 

Date:

 

Wednesday, May 13, 2020

Time:

 

4:30 p.m. Eastern Time

Toll Free:

 

(877) 407-0789

International:

 

(201) 689-8562

Conference ID:

 

13703169

Webcast:

 

http://public.viavid.com/index.php?id=139651

 

 

About HTG:

HTG is focused on NGS-based molecular profiling. The company’s proprietary HTG EdgeSeq technology automates complex, highly multiplexed molecular profiling from solid and liquid samples, even when limited in amount. HTG’s customers use its technology to identify biomarkers important for precision medicine, to understand the clinical relevance of these discoveries, and ultimately to identify treatment options. Its mission is to empower precision medicine.

 

 

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 being on track to deliver development milestones and our expectations for increased demand for our products and services in the future and our ability to meet those demands. 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, risks associated with the impact of the COVID-19 pandemic on the company and its customers; the risk that products that we expect to develop in 2020 are not developed or released; the risk that we may not establish new and significant collaboration development arrangements; 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 third party payor reimbursement for our products; 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 third parties; competition in our industry; additional capital and credit availability; 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 Annual Report on Form 10-K for the year ended December 31, 2019. 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:

 

Ashley Robinson

Phone: (617) 430-7577

Email: arr@lifesciadvisors.com

 

 


 

-Financial tables follow-



 

HTG Molecular Diagnostics, Inc.

 

Condensed Consolidated Statements of Operations

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31,

 

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

Product and product-related services

 

$

1,988,137

 

 

$

2,662,505

 

Collaborative development services

 

 

237,337

 

 

 

540,320

 

Total revenue

 

 

2,225,474

 

 

 

3,202,825

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

     Cost of product and product-related services revenue

 

 

1,015,492

 

 

 

2,045,527

 

     Selling, general and administrative

 

 

4,675,263

 

 

 

4,400,866

 

     Research and development

 

 

1,926,275

 

 

 

2,074,748

 

Total operating expenses

 

 

7,617,030

 

 

 

8,521,141

 

Operating loss

 

 

(5,391,556

)

 

 

(5,318,316

)

Other income (expense), net

 

 

(61,166

)

 

 

(52,530

)

Net loss before income taxes

 

 

(5,452,722

)

 

 

(5,370,846

)

Provision for income taxes

 

 

(5,176

)

 

 

 

Net loss

 

$

(5,457,898

)

 

$

(5,370,846

)

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.08

)

 

$

(0.19

)

Shares used in computing net loss per share, basic and diluted

 

 

64,567,932

 

 

 

28,600,679

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



HTG Molecular Diagnostics, Inc.

 

Condensed Consolidated Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31,

 

 

December 31,

 

 

 

2020

 

 

2019

 

Assets

 

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

10,403,697

 

 

$

7,619,748

 

Short-term investments available-for-sale, at fair value

 

 

21,554,318

 

 

 

25,410,222

 

Restricted cash

 

 

3,270,247

 

 

 

3,270,247

 

Accounts receivable

 

 

1,202,469

 

 

 

3,164,176

 

Inventory, net

 

 

1,637,898

 

 

 

1,269,667

 

Prepaid expenses and other

 

 

525,647

 

 

 

633,522

 

Total current assets

 

 

38,594,276

 

 

 

41,367,582

 

 

 

 

 

 

 

 

 

 

Operating lease right-of-use assets

 

 

1,039,045

 

 

 

1,209,145

 

Property and equipment, net

 

 

2,169,663

 

 

 

2,240,133

 

Other non-current assets

 

 

123,086

 

 

 

302,409

 

Total assets

 

$

41,926,070

 

 

$

45,119,269

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,666,819

 

 

$

1,662,583

 

Accrued liabilities

 

 

1,195,827

 

 

 

1,870,296

 

Contract liabilities - current

 

 

409,449

 

 

 

426,014

 

NuvoGen obligation - current

 

 

1,093,592

 

 

 

1,152,233

 

MidCap Term Loan payable - current

 

 

280,000

 

 

 

 

Convertible note - current, net of debt issuance costs

 

 

2,991,031

 

 

 

2,987,667

 

Operating lease liabilities - current

 

 

696,301

 

 

 

758,932

 

Other current liabilities

 

 

36,205

 

 

 

41,134

 

Total current liabilities

 

 

8,369,224

 

 

 

8,898,859

 

NuvoGen obligation - non-current, net of discount

 

 

4,265,991

 

 

 

4,498,777

 

MidCap Term Loan payable - net of discount and debt issuance costs

 

 

6,629,972

 

 

 

6,871,545

 

Operating lease liabilities - non-current

 

 

512,718

 

 

 

636,340

 

Other non-current liabilities

 

 

234,981

 

 

 

244,114

 

Total liabilities

 

 

20,012,886

 

 

 

21,149,635

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

Total stockholders’ equity

 

 

21,913,184

 

 

 

23,969,634

 

Total liabilities and stockholders' equity

 

$

41,926,070

 

 

$

45,119,269