EX-99.1 2 htgm-ex991_6.htm EX-99.1 htgm-ex991_6.htm

 

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

 

HTG Molecular Diagnostics Reports Second Quarter 2016 Results

 

 

TUCSON, Ariz., August 9, 2016 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (NASDAQ:HTGM), a provider of instruments and reagents for molecular profiling applications, today reported financial results for the three and six month periods ended June 30, 2016.

 

Recent Accomplishments & Highlights:

 

 

·

Achieved revenue of $1.9 million for the second quarter of 2016.

 

·

Announced an agreement with Firalis S.A. to support development of an NGS-based theranostic tool to predict patient response to anti-TNFα therapies to allow for improved patient management in the treatment of rheumatoid arthritis.

 

·

Announced our VERI/O laboratory service, offering laboratory support services for our biopharmaceutical company customers in biomarker research and companion diagnostic development.

 

·

Obtained CE/IVD marking for the HTG EdgeSeq DLBCL Cell of Origin Assay, allowing the commercialization of this diagnostic assay in Europe.  

 

·

Initiated HTG EdgeSeq ALKPlus Assay clinical trial for planned pre-market approval (PMA) application for FDA review as a companion diagnostic.

“At the midpoint of our year we are very pleased with progress against our strategic milestones.  The building blocks of our diagnostic business are coming together,” said TJ Johnson, HTG President and CEO.  “Obtaining our first regulatory approval was a major accomplishment for our organization.”

 

Second Quarter 2016 Financial Results:

Revenue for the second quarter of 2016 was $1.9 million, a 140% increase over the second quarter of 2015, primarily a result of increased service revenue, which was $1.3 million for the quarter. Consumables revenue was $0.6 million for the quarter.

 

Net loss from operations for the second quarter of 2016 was $6.4 million, compared to $4.7 million for the second quarter of 2015. Net loss per share was $(0.98) for the second quarter of 2016 compared to $(1.73) for the second quarter of 2015.

 

HTG ended the second quarter with $22.9 million in total cash and investments.

 

Conference Call and Webcast:

HTG will host an investment community conference call today beginning at 4:30 p.m. ET. Individuals interested in listening to the conference call may dial (866) 394-4225 for domestic callers, or (678) 509-7535 for international callers, conference ID 47539777, or access the webcast on the investor relations section of the company’s

 


 

website at: www.htgmolecular.com. The webcast will be available on the company’s website for 90 days following the completion of the call.

 

 

About HTG:

Headquartered in Tucson, Arizona, HTG's mission is to empower precision medicine at the local level. In 2013 the company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG's proprietary nuclease protection chemistry. HTG's product offerings have since expanded to include its HTG EdgeSeq product line, which automates sample and targeted library preparation for next-generation sequencing.

 

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 activities expected to occur in connection with Firalis’ assay development, the expected benefits of our VERI/O laboratory service offerings, our ability to commercialize diagnostic products in Europe, and our planned clinical trials.  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 agreements, risks associated with our ability to successfully commercialize our products; 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; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2016.  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.

 

-Financial tables follow-

 

 

 

 

 

 

 

 

 

 


 

HTG Molecular Diagnostics, Inc.

 

Statements of Operations

 

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Product

 

$

577,127

 

 

$

648,347

 

 

$

1,177,317

 

 

$

1,375,785

 

     Service

 

 

1,318,689

 

 

 

51,000

 

 

 

1,583,731

 

 

 

113,292

 

     Other

 

 

 

 

 

91,204

 

 

 

 

 

 

325,789

 

Total revenue

 

 

1,895,816

 

 

 

790,551

 

 

 

2,761,048

 

 

 

1,814,866

 

Cost of revenue

 

 

932,976

 

 

 

834,949

 

 

 

1,776,446

 

 

 

1,729,575

 

Gross margin

 

 

962,840

 

 

 

(44,398

)

 

 

984,602

 

 

 

85,291

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

     Selling, general and administrative

 

 

4,712,637

 

 

 

3,726,490

 

 

 

9,406,345

 

 

 

7,165,759

 

     Research and development

 

 

2,611,591

 

 

 

953,222

 

 

 

4,605,692

 

 

 

1,641,437

 

Total operating expenses

 

 

7,324,228

 

 

 

4,679,712

 

 

 

14,012,037

 

 

 

8,807,196

 

Operating loss

 

 

(6,361,388

)

 

 

(4,724,110

)

 

 

(13,027,435

)

 

 

(8,721,905

)

Loss from change in stock warrant valuation

 

 

 

 

 

(628,643

)

 

 

 

 

 

(239,683

)

Interest expense, net

 

 

(507,797

)

 

 

(465,006

)

 

 

(864,775

)

 

 

(944,306

)

Loss on settlement of convertible debt

 

 

 

 

 

(705,217

)

 

 

 

 

 

(705,217

)

Other

 

 

18,442

 

 

 

70,634

 

 

 

18,442

 

 

 

70,634

 

Net loss before income taxes

 

 

(6,850,743

)

 

 

(6,452,342

)

 

 

(13,873,768

)

 

 

(10,540,477

)

Income taxes

 

 

860

 

 

 

 

 

 

4,259

 

 

 

 

Net loss

 

 

(6,851,603

)

 

 

(6,452,342

)

 

 

(13,878,027

)

 

 

(10,540,477

)

Accretion of redeemable convertible preferred stock discount, issuance costs and dividends

 

 

 

 

 

(418,465

)

 

 

 

 

 

(1,328,594

)

Net loss attributable to common stockholders

 

$

(6,851,603

)

 

$

(6,870,807

)

 

$

(13,878,027

)

 

$

(11,869,071

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.98

)

 

$

(1.73

)

 

$

(2.00

)

 

$

(5.49

)

Shares used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

7,018,502

 

 

 

3,973,055

 

 

 

6,952,012

 

 

 

2,163,295

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

HTG Molecular Diagnostics, Inc.

 

Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2016

 

 

2015

 

Assets

 

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

7,510,493

 

 

$

3,293,983

 

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

 

 

15,405,414

 

 

 

28,201,507

 

Accounts receivable

 

 

1,911,394

 

 

 

716,246

 

Inventory, net

 

 

2,213,108

 

 

 

2,201,301

 

Prepaid expenses and other

 

 

673,940

 

 

 

445,217

 

Total current assets

 

 

27,714,349

 

 

 

34,858,254

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

2,603,901

 

Property and equipment, net

 

 

3,957,952

 

 

 

1,932,213

 

Total assets

 

$

31,672,301

 

 

$

39,394,368

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,607,044

 

 

$

724,805

 

Accrued liabilities

 

 

1,639,534

 

 

 

1,915,268

 

Deferred revenue

 

 

183,707

 

 

 

47,476

 

NuvoGen obligation

 

 

762,500

 

 

 

543,750

 

Term loan

 

 

6,122,450

 

 

 

3,059,068

 

Other current liabilities

 

 

264,578

 

 

 

29,243

 

Total current liabilities

 

 

10,579,813

 

 

 

6,319,610

 

Term loan payable - non-current, net of discount and debt issuance costs

 

 

8,368,215

 

 

 

7,737,586

 

NuvoGen obligation - non-current, net of discount

 

 

8,119,589

 

 

 

8,415,122

 

Other

 

 

587,034

 

 

 

28,652

 

Total liabilities

 

 

27,654,651

 

 

 

22,500,970

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

Total stockholders’ equity

 

 

4,017,650

 

 

 

16,893,398

 

Total liabilities and stockholders' equity

 

$

31,672,301

 

 

$

39,394,368

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Contact:

 

Westwicke Partners

Jamar Ismail

Phone: 415-513-1282

Email: jamar.ismail@westwicke.com

 

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