HTG Molecular Diagnostics Reports First Quarter 2018 Results

May 10, 2018 at 4:01 PM EDT

Revenue increased 203% compared to the three-month period in the prior year         

Call scheduled for today, May 10, at 4:30 pm ET

TUCSON, Ariz., May 10, 2018 (GLOBE NEWSWIRE) -- HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM) (HTG), a provider of instruments, reagents and services for molecular profiling applications, today reported financial results for the first quarter ended March 31, 2018.

Recent Accomplishments & Highlights:

  • Entered into a third statement of work for a new clinical assay development program under its Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”) with QIAGEN Manchester Limited, a wholly owned subsidiary of QIAGEN N.V.
     
  • Announced the second amendment to the first statement of work for next phase development activities under the Governing Agreement, representing low, single-digit millions of dollars in development fees and profit sharing payments.   
     
  • Entered into a non-exclusive license and supply agreement with Firalis S.A. (“Firalis”) enabling Firalis to develop and commercialize a theranostic test to predict a rheumatoid arthritis (RA) patient’s response to anti‑TNFα therapy, the primary therapy for millions of RA patients. The new assay using Firalis’ gene expression signature, BIOPRED, would be commercialized on the HTG EdgeSeq platform.
  • Announced a new Precision Immuno-Oncology panel of over 1,300 genes with an expected Q3 2018 availability, to be featured at the 2018 American Society of Clinical Oncology (ASCO) annual meeting.
  • Completed an underwritten public offering of 13,915,000 shares of its common stock at a price of $2.90 per share for aggregate net proceeds of approximately $37.7 million.             
  • Entered into a senior debt facility for up to $30.0 million with MidCap Financial (MidCap), a healthcare technology firm, to replace its existing senior credit facility and provide additional working capital for the Company.
  • Announced the promotion of John Lubniewski to President and Chief Operating Officer. Mr. Lubniewski has served as HTG’s chief business officer for the past seven years, bringing over three decades of experience in the life science industry.

“We are off to a solid start in 2018 and executing well, but continue to expect uneven quarterly revenue,” said TJ Johnson, Chief Executive Officer of HTG. “Our BioPharma programs are progressing as expected, we are launching an exciting new immuno-oncology panel early in the third quarter of 2018, and believe we have additional, potential catalysts in front of us.”

First Quarter 2018 Financial Results:

Total revenue for the first quarter of 2018 was $4.2 million, an increase of 203% over the same period in the prior year. The increase in current year revenue is primarily due to our BioPharma development programs and steady growth of our RUO profiling services.

Product and product-related services revenue was $1.7 million, compared to $1.4 million to the same period in 2017. Collaborative development services revenue was approximately $2.4 million compared to $0 for the same period in 2017.

Gross margin was $3.0 million for the first quarter of 2018 compared to $76,000 for the first quarter of 2017. Net loss from operations for the first quarter of 2018 was $5.2 million compared to $5.4 million for the first quarter of 2017. Net loss per share was $(0.22) for the first quarter of 2018 compared to $(0.73) for the first quarter of 2017.

HTG ended the first quarter with $45.6 million including cash, cash equivalents and short term, available-for-sale securities investments.

2018 Revenue Guidance:

HTG is increasing the lower end of the Company’s full-year revenue guidance to $21.0 to $25.0 million. Previous guidance was $20.0 to $25.0 million.

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, May 10, 2018
Time:   4:30 p.m. Eastern Time
Toll Free:   (866) 548-4713
International:   (323) 794-2093
Conference ID:   5477857
Webcast:   http://public.viavid.com/index.php?id=129155

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.

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 planned Precision Immuno-Oncology panel, and our revenue and operational expectations. 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 Precision Immuno-Oncology panel may not function or provide benefits to our customers as expected, 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), the risk that we may not realize the benefits expected under our collaboration agreements, 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; 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, 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.

-Financial tables follow-                          

   
HTG Molecular Diagnostics, Inc.  
Statements of Operations  
 (Unaudited)  
                 
    Three Months Ended March 31,  
    2018     2017  
Revenue:                
Product and product-related services   $ 1,733,546     $ 1,371,169  
Collaborative development services     2,425,106        
Total revenue     4,158,652       1,371,169  
Cost of revenue     1,137,063       1,295,302  
Gross margin     3,021,589       75,867  
                 
Operating expenses:                
  Selling, general and administrative     5,657,832       4,238,467  
  Research and development     2,589,286       1,267,063  
Total operating expenses     8,247,118       5,505,530  
Operating loss     (5,225,529 )     (5,429,663 )
Loss on settlement of Growth Term Loan     (105,064 )      
Other expense, net     (49,354 )     (386,331 )
Net loss before income taxes     (5,379,947 )     (5,815,994 )
Provision for income taxes           280  
Net loss   $ (5,379,947 )   $ (5,816,274 )
                 
Net loss per share, basic and diluted   $ (0.22 )   $ (0.73 )
Shares used in computing net loss per share, basic and diluted     24,704,128       7,971,097  
                 
   


HTG Molecular Diagnostics, Inc.  
Balance Sheets  
                     
                     
    March 31,         December 31,  
    2018         2017  
Assets      (Unaudited)              
Current assets:                    
Cash and cash equivalents   $ 20,530,960         $ 9,968,600  
Short-term investments available-for-sale, at fair value     25,125,209            
Accounts receivable     2,836,526           6,356,268  
Contract assets     167,835            
Inventory, net of allowance of $63,943 at March 31, 2018 and $62,142 at December 31, 2017     1,042,017           1,180,521  
Prepaid expenses and other     464,562           443,068  
Total current assets     50,167,109           17,948,457  
                     
Deferred offering costs               2,953  
Deferred MidCap revolving loan costs     79,197            
Property and equipment, net     3,099,479           3,304,890  
Total assets   $ 53,345,785         $ 21,256,300  
                     
Liabilities and stockholders' deficit                    
Current liabilities:                    
Accounts payable     2,216,115           2,438,798  
Accrued liabilities     1,681,183           3,746,786  
Contract liabilities - current     462,934           665,882  
NuvoGen obligation - current     560,668           496,442  
Growth Term Loan payable - current, net of discount and debt issuance costs               5,793,599  
Other current liabilities     202,564           200,460  
Total current liabilities     5,123,464           13,341,967  
NuvoGen obligation - non-current, net of discount     7,268,161           7,520,913  
Convertible note, related party - net of debt issuance costs     2,964,123           2,960,760  
MidCap Term Loan payable - net of discount and debt issuance costs     6,585,731            
Other non-current liabilities     435,017           492,197  
Total liabilities     22,376,496           24,315,837  
Commitments and Contingencies (Note 13)                    
Stockholders’ equity (deficit):                    
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2018 and December 31, 2017, 28,358,925 shares issued and outstanding at March 31, 2018 and 13,929,763 shares issued and outstanding at December 31, 2017     28,359           13,929  
Additional paid-in-capital     170,898,089           131,492,595  
Accumulated other comprehensive loss     (11,151 )          
Accumulated deficit     (139,946,008 )         (134,566,061 )
Total stockholders’ equity (deficit)     30,969,289           (3,059,537 )
Total liabilities and stockholders' equity (deficit)   $ 53,345,785         $ 21,256,300  
                     

Contact:

Ashley Robinson
LifeSci Advisors, LLC
Phone: (617) 775-5956
Email: arr@lifesciadvisors.com

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

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Source: HTG Molecular Diagnostics, Inc.