htgm-8k_20180322.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

March 22, 2018

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))

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 March 22, 2018, HTG Molecular Diagnostics, Inc. issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2017. 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 March 22, 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: March 22, 2018

 

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 Fourth Quarter and Full Year 2017 Results

 

Revenue increased 442% and 188%, respectively, compared to the three and twelve month periods in the prior year driven by development efforts supporting Pharma clinical programs

 

TUCSON, Ariz., March 22, 2018 -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (HTG), a provider of instruments, reagents and services for molecular profiling applications, today reported its financial results for the fourth quarter and year ended December 31, 2017.

 

Recent Accomplishments & Highlights:

 

 

Achieved revenue of $7.9 million and $14.8 million for the three and twelve months ended December 31, 2017, respectively, which represents a 442% and 188% increase over the respective periods in 2016. Fourth quarter and full year 2017 revenue was driven primarily by the company’s collaborative development services programs.

 

 

Completed underwritten public offering of 13,915,000 shares of its common stock at a price to the public of $2.90 per share, including 1,815,000 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares, in January 2018. The aggregate net proceeds from the offering were approximately $37.7 million, after deducting the underwriting discounts and commissions and offering expenses.

 

 

Entered into a third statement of work for a new clinical assay development program under the company’s Master Assay Development, Commercialization and Manufacturing Agreement with QIAGEN Manchester Limited, (QML), a wholly owned subsidiary of QIAGEN, N.V. (NYSE:QGEN), in connection with a sponsor project agreement between QML and a pharmaceutical company, in January 2018.

 

 

Entered into a new master collaboration agreement for translational programs with Merck KGaA, Darmstadt, Germany, in December 2017. The master collaboration agreement complements the previously announced master companion diagnostic agreement with Merck KGaA, and includes a statement of work with EMD Serono, the biopharmaceutical business of Merck KGaA, in the United States and Canada.

 

 

“We entered 2017 with specific goals to accelerate customer adoption, expand our BioPharma pipeline, initiate commercialization of our CE/IVD products in Europe and strengthen our balance sheet.  2017 exceeded our performance expectations, and we move into 2018 looking forward to continuing our momentum,” said TJ Johnson, President and CEO of HTG Molecular Diagnostics.


 


 

Fourth Quarter 2017 Financial Results:

Revenue for the fourth quarter of 2017 was $7.9 million, compared to $1.5 million for the fourth quarter of 2016. Net loss from operations for the fourth quarter of 2017 was $1.7 million, compared to $5.2 million for the fourth quarter of 2016.

 

Net loss for the fourth quarter of 2017 was $1.9 million, compared to $5.7 million for the fourth quarter of 2016. Net loss per share was $(0.15) for the fourth quarter of 2017 compared to $(0.76) for the fourth quarter of 2016.

 

Full Year 2017 Financial Results:

Revenue for the year ended December 31, 2017 was $14.8 million, compared to $5.1 million for the year ended December 31, 2016. Net loss from operations for the year ended December 31, 2017 was $17.7 million, compared to $24.3 million for year ended December 31, 2016.

Net loss for the year ended December 31, 2017 was $19.0 million, compared to $26.0 million for the year ended December 31, 2016. Net loss per share for the year ended December 31, 2017 was $(1.79) compared to $(3.66) for the year ended December 31, 2016.

HTG ended 2017 with $10.0 million in cash and equivalents and current liabilities of approximately $13.3 million plus an additional $11.0 million in non-current liabilities. Net proceeds from the underwritten public offering completed on January 23, 2018 were approximately $37.7 million, after deducting for underwriting discounts and commissions and offering expenses.

 

 

Conference Call and Webcast:

HTG will host an investment community conference call today beginning at 4:30 p.m. Eastern Time. Conference call and webcast details follow:

 

Date:Thursday, March 22

Time:4:30pm Eastern Time

Toll Free:(800) 239-9838

International:(323) 794-2551

Conference ID:7843064

Webcast:http://public.viavid.com/index.php?id=128362

 

 

About HTG:

HTG is focused on next generation sequencing (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. Our mission is to empower precision medicine at the local level.

 

 

-Financial tables follow-



 

HTG Molecular Diagnostics, Inc.

 

Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

 

Years Ended December 31,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Product and product-related services

 

$

2,374,951

 

 

$

1,457,781

 

 

$

6,797,255

 

 

$

5,132,730

 

     Collaborative development services

 

 

5,529,207

 

 

 

 

 

 

7,962,312

 

 

 

 

Total revenue

 

 

7,904,158

 

 

 

1,457,781

 

 

 

14,759,567

 

 

 

5,132,730

 

Cost of revenue

 

 

1,350,613

 

 

 

1,234,429

 

 

 

4,971,806

 

 

 

4,135,884

 

Gross margin

 

 

6,553,545

 

 

 

223,352

 

 

 

9,787,761

 

 

 

996,846

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Selling, general and administrative

 

 

4,603,491

 

 

 

4,083,832

 

 

 

17,513,742

 

 

 

17,427,777

 

     Research and development

 

 

3,632,256

 

 

 

1,384,503

 

 

 

9,996,627

 

 

 

7,900,311

 

Total operating expenses

 

 

8,235,747

 

 

 

5,468,335

 

 

 

27,510,369

 

 

 

25,328,088

 

Operating loss

 

 

(1,682,202

)

 

 

(5,244,983

)

 

 

(17,722,608

)

 

 

(24,331,242

)

Other expense, net

 

 

(237,895

)

 

 

(422,239

)

 

 

(1,234,488

)

 

 

(1,698,190

)

Net loss before income taxes

 

 

(1,920,097

)

 

 

(5,667,222

)

 

 

(18,957,096

)

 

 

(26,029,432

)

Provision for income taxes

 

 

1,898

 

 

 

5,859

 

 

 

2,921

 

 

 

10,118

 

Net loss

 

$

(1,921,995

)

 

$

(5,673,081

)

 

$

(18,960,017

)

 

$

(26,039,550

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.15

)

 

$

(0.76

)

 

$

(1.79

)

 

$

(3.66

)

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

 

 

12,979,143

 

 

 

7,488,842

 

 

 

10,597,318

 

 

 

7,113,075

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



HTG Molecular Diagnostics, Inc.

 

Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31,

 

 

 

2017

 

 

2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

9,968,600

 

 

$

7,507,659

 

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

 

 

 

 

 

4,304,901

 

Accounts receivable

 

 

6,356,268

 

 

 

1,377,441

 

Inventory, net

 

 

1,180,521

 

 

 

1,511,053

 

Prepaid expenses and other

 

 

443,068

 

 

 

433,328

 

Total current assets

 

 

17,948,457

 

 

 

15,134,382

 

 

 

 

 

 

 

 

 

 

Deferred offering costs

 

 

2,953

 

 

 

49,630

 

Property and equipment, net

 

 

3,304,890

 

 

 

3,270,197

 

Total assets

 

$

21,256,300

 

 

$

18,454,209

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' deficit

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,438,798

 

 

$

761,663

 

Accrued liabilities

 

 

3,746,786

 

 

 

1,670,286

 

Deferred revenue - current

 

 

665,882

 

 

 

335,659

 

NuvoGen obligation - current

 

 

496,442

 

 

 

604,751

 

Term loan payable - current, net of discount and debt issuance costs of $64,807 at December 31, 2017 and $0 at December 31, 2016

 

 

5,793,599

 

 

 

6,389,782

 

Other current liabilities

 

 

200,460

 

 

 

258,850

 

Total current liabilities

 

 

13,341,967

 

 

 

10,020,991

 

Term loan payable - non-current, net of discount and debt issuance costs of $0 at December 31, 2017 and $263,378 at December 31, 2016

 

 

 

 

 

5,389,137

 

NuvoGen obligation - non-current, net of discount

 

 

7,520,913

 

 

 

8,017,356

 

Convertible note, related party - net of debt issuance costs

 

 

2,960,760

 

 

 

 

 

Other non-current liabilities

 

 

492,197

 

 

 

619,587

 

Total liabilities

 

 

24,315,837

 

 

 

24,047,071

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

Total stockholders’ deficit

 

 

(3,059,537

)

 

 

(5,592,862

)

Total liabilities and stockholders' deficit

 

$

21,256,300

 

 

$

18,454,209

 

 

 

 

 

 

 

 

 

 



Contact:

 

Ashley Robinson

LifeSci Advisors, LLC

Phone: (617) 775-5956

Email: arr@lifesciadvisors.com

 

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