Lipocine Inc.
Nov 8, 2016

Lipocine Announces Financial and Operational Results for the Third Quarter of 2016

SALT LAKE CITY, Nov. 08, 2016 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial and operational results for the quarter ended September 30, 2016.

Quarterly and Recent Highlights

"We were pleased to have completed our Post Action meeting with the FDA, which we believe was very productive and identified a path to bring our NDA for LPCN 1021 into a position for approval, as we remained committed to the product," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "In addition, we continue to make substantial progress with both of our other pipeline products, most notably delivering positive clinical data for LPCN 1111 during the quarter."

Third Quarter 2016 Financial Results

The net loss for the third quarter of 2016 narrowed as compared with the net loss for the third quarter of 2015.  Lipocine reported a net loss of $3.2 million, or $0.18 per diluted share, for the third quarter of 2016, compared with a net loss of $6.4 million, or $0.35 per diluted share, for the third quarter of 2015.

For the third quarter of 2016, research and development expenses were $1.5 million, compared with $4.7 million for the third quarter of 2015. The change was primarily due to decreased contract research organization and consultant costs as well as a $2.3 million fee paid in 2015 to file our NDA for LPCN 1021 with the FDA.  These decreases were partially offset by an increase in validation and commercial batch manufacturing costs for LPCN 1021.

For the third quarter of 2016, general and administrative expenses were $1.4 million, compared with $1.7 million for the third quarter of 2015. The decrease was primarily due to decreased pre-commercialization marketing and sales activities related to LPCN 1021 partially offset by an increase in personnel costs. 

As of September 30, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $28.8 million, compared with cash and cash equivalents of $44.8 million as of December 31, 2015.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a twice-daily oral testosterone replacement therapy product candidate, was well tolerated and met the primary efficacy end point in Phase 3 testing, which utilized 24-hour pharmacokinetic data for dose adjustments.  LPCN 1111, a novel prodrug of testosterone, originated with and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.  LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA was recently completed. For more information, please visit

Forward-Looking Statements

This release contains "forward looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding Lipocine's FDA review process relating to LPCN 1021, the additional clinical trial needed to validate our dosing regimen and the FDA process with respect to our planned SPA, the possible outcome and timing of such clinical trial or FDA review process, the path to approvability by the FDA of LPCN 1021, our commitment to bring LPCN 1021 to market, the results of the Phase 2b clinical study of LPCN 1111, the potential uses and benefits of our product candidates, and our product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks that the FDA will not approve LPCN 1021 or any of our other products, risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the receipt of a CRL from the FDA for LPCN 1021, the receipt of regulatory approvals, the results and timing of clinical trials, including the additional clinical trial for LPCN 1021, patient acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in Lipocine's filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

 Condensed Consolidated Statements of Operations and Comprehensive Loss
       Three Months Ending September 30, Nine Months Ending September 30,
        2016   2015   2016   2015 
 Operating expenses:        
  Research and development $1,506,581  $4,733,889  $6,747,673  $9,814,492 
  General and administrative  1,394,406   1,700,099   9,038,837   3,871,478 
  Restructuring costs  385,233   -   385,233   - 
   Total operating expenses  3,286,220   6,433,988   16,171,743   13,685,970 
   Operating loss  (3,286,220)  (6,433,988)  (16,171,743)  (13,685,970)
 Other income, net  50,735   61,560   167,403   111,490 
   Loss before income tax expense  (3,235,485)  (6,372,428)  (16,004,340)  (13,574,480)
 Income tax expense  -   -   (700)  (200)
   Net loss $(3,235,485) $(6,372,428) $(16,005,040) $(13,574,680)
 Basic loss per share attributable to common stock $(0.18) $(0.35) $(0.88) $(0.86)
 Weighted average common shares outstanding, basic  18,252,681   18,238,632   18,252,092   15,871,252 
 Diluted loss per share attributable to common stock $(0.18) $(0.35) $(0.88) $(0.86)
 Weighted average common shares outstanding, diluted  18,252,681   18,238,632   18,252,092   15,871,252 
 Comprehensive loss:        
   Net loss $(3,235,485) $(6,372,428) $(16,005,040) $(13,574,680)
   Net unrealized gain (loss) on available-for-sale securities  (5,824)  15,887   33,022   5,802 
   Comprehensive loss $(3,241,309) $(6,356,541) $(15,972,018) $(13,568,878)

Condensed Consolidated Balance Sheets
    September 30, December 31, 
     2016   2015  
Current assets:       
Cash and cash equivalents  $4,706,639  $20,007,659  
Marketable investment securities  24,132,453   24,375,168  
Accrued interest income   115,205   144,536  
Prepaid and other current assets  457,430   350,160  
Total current assets    29,411,727   44,877,523  
Property and equipment, net of accumulated depreciation of $1,084,474 and $1,060,750, respectively  111,676   75,750  
Long-term marketable investment securities  -   400,252  
Other assets    30,753   23,753  
Total assets   $29,554,156  $45,377,278  
Liabilities and Stockholders' Equity       
Current liabilities:       
Accounts payable   $864,951  $507,067  
Accrued expenses    707,299   2,884,794  
Total current liabilities    1,572,250   3,391,861  
Total liabilities    1,572,250   3,391,861  
Commitments and contingencies     
Stockholders' equity:       
Preferred stock, par value $0.0001 per share, 10,000,000 shares authorized; zero issued and outstanding    -   -  
Common stock, par value $0.0001 per share, 100,000,000 shares authorized; 18,258,901 and 18,250,456 issued and 18,253,191 and 18,244,746 outstanding    1,826   1,825  
Additional paid-in capital   130,471,165   128,502,659  
Treasury stock at cost, 5,710 shares  (40,712)  (40,712) 
Accumulated other comprehensive income (loss)  122   (32,900) 
Accumulated deficit    (102,450,495)  (86,445,455) 
Total stockholders' equity   27,981,906   41,985,417  
Total liabilities and stockholders' equity  $29,554,156  $45,377,278  
Morgan Brown

Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383

John Woolford
Phone: (443) 213-0506