Lipocine Announces Second Quarter 2019 Financial and Operational Results

SALT LAKE CITY, Aug. 7, 2019 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced financial results for the second quarter and six months ended June 30, 2019 and provided a corporate update.

Second Quarter and Recent Corporate Highlights

    --  Filed a New Drug Application ("NDA") for TLANDO(TM) as testosterone
        replacement therapy ("TRT") in adult males for conditions associated
        with a deficiency of endogenous testosterone, also known as
        hypogonadism.
        --  The FDA has assigned November 9, 2019 as the Prescription Drug User
            Fee Act ("PDUFA") goal date.
    --  Received clearance from the U.S. Food and Drug Administration ("FDA") to
        clinically investigate LPCN 1144 in an expanded target population of
        adult male non-alcoholic steatohepatitis ("NASH") patients.
        --  FDA has waived the limitation of only testing in NASH subjects with
            total testosterone levels below 300 ng/dL (threshold for
            hypogonadism).
    --  Initiated the LiFT ("Liver Fat intervention with oral Testosterone")
        LPCN 1144 Phase 2 clinical study, a paired-biopsy study in confirmed
        pre-cirrhotic NASH subjects.
    --  Filed suit against Clarus Therapeutics, Inc. ("Clarus") in the United
        States District Court ("Delaware") alleging that Clarus's JATENZO(®)
        product infringes six of Lipocine's U.S. patents.
    --  Joined the Russell Microcap(®) Index effective July 1, 2019 as a result
        of the Russell indexes annual reconstitution.

"During the second quarter, we continued to advance our pipeline, with important milestones achieved for both TLANDO and LPCN 1144," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "The acceptance of the NDA for TLANDO for treating hypogonadism in males puts us on track for potential approval of this product in the fourth quarter of 2019. TLANDO is designed as a fixed dose oral TRT. For LPCN 1144, we were excited to initiate the LiFT study in biopsy confirmed NASH subjects, and based on our observed meaningful liver fat reduction in hypogonadal males, receive FDA clearance to expand our target patient population in adult NASH males regardless of their hypogonadal status. We believe this increases LPCN 1144's potential utility in a broader NASH population who reportedly have low testosterone."

Second Quarter Ended June 30, 2019 Financial Results

Lipocine reported a net loss of $3.4 million, or ($0.14) per diluted share, for the quarter ended June 30, 2019, compared with a net loss of $3.3 million, or ($0.15) per diluted share, in the quarter ended June 30, 2018.

Research and development expenses were $2.0 million for the quarter ended June 30, 2019, compared with $1.5 million for the quarter ended June 30, 2018. The increase in research and development expenses was primarily due to increases in outside service costs related to the second quarter initiation of the LiFT LPCN 1144 Phase 2 clinical study in confirmed pre-cirrhotic NASH subjects and increased contract research organization and outside consulting costs for TLANDO in connection with completion of the ABPM study and the filing of the NDA.

General and administrative expenses were $1.4 million for the quarter ended June 30, 2019, compared with $1.7 million for the quarter ended June 30, 2018. The decrease in general and administrative was primarily due to decreased personnel costs, a decrease in severance compensation, a decrease in stock compensation expense and a decrease in bonus expense. The decreases were offset by increases in other general and administrative expenses including an increase in professional fees, an increase in corporate insurance and an increase in marketing expenses.

As of June 30, 2019, the Company had total cash, cash equivalents and marketable securities aggregating $19.5 million, compared to $20.3 million at December 31, 2018. Of the total cash, cash equivalents and marketable securities balances, $5.0 million is restricted under our agreement with Silicon Valley Bank until TLANDO receives approval.

Six Months Ended June 30, 2019 Financial Results

Lipocine reported a net loss of $6.7 million, or ($0.28) per diluted share, for the six months ended June 30, 2019, compared with a net loss of $6.0 million, or ($0.28) per diluted share, in the six months ended June 30, 2018.

Research and development expenses were $3.9 million for the six months ended June 30, 2019, compared with $2.9 million for the six months ended June 30, 2018. The increase/decrease in research and development expenses was primarily due to increased contract research organization and outside consulting costs for TLANDO in connection with completion of the ABPM study and the filing of the NDA, increased manufacturing costs for TLANDO, increased outside service costs related to the second quarter initiation of the LiFT LPCN 1144 Phase 2 clinical study in confirmed pre-cirrhotic NASH subjects, increased outside contract research organization costs and sample storage costs related to TLANDO XR (LPCN 1111) offset by decreased contract manufacturing costs for LPCN 1107 and decreased personnel costs.

General and administrative expenses were $2.6 million for the six months ended June 30, 2019, compared with $3.4 million for the six months ended June 30, 2018. The decrease in general and administrative was primarily due to decreased personnel costs, which includes a decrease in salaries and related benefits mainly from the elimination of our commercial sales and marketing team in 2018, a decrease in severance compensation, a decrease in stock compensation expense and a decrease in bonus expense of $12,000. The decreases were offset by increases in other general and administrative expenses including an increase in professional fees and an increase in corporate insurance.

About Lipocine

Lipocine Inc. is a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes four development programs TLANDO, LPCN 1144, TLANDO XR (LPCN 1111) and LPCN 1107. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1144, an oral product of bioidentical testosterone, recently completed a proof-of-concept clinical study demonstrating the potential utility the in treatment of NASH. TLANDO XR (LPCN 1111), a novel oral prodrug of testosterone, originated 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 is potentially the first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed. For more information, please visit www.lipocine.com.

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 product candidates and related clinical trials, the potential patient population for our product candidates, the timing of completion of clinical trials and expected FDA approvals, 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 any of our products, risks related to our products, expected product benefits not being realized, clinical and regulatory expectations and plans not being realized, new regulatory developments and requirements, risks related to the FDA approval process including the receipt of regulatory approvals, the results and timing of clinical trials, 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 www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.




                                                        
            
              LIPOCINE INC. AND SUBSIDIARIES




                                                          
            Condensed Consolidated Balance Sheets




                                                                       
            (Unaudited)




                                                                 
            
              June 30,                
     
     December 31,


                                                                                                        2019                      2018



            
            
              Assets



     Current assets:


                                                      
      Cash and cash equivalents                                         $3,664,319      $8,077,539


                                                      
      Restricted cash                                                    5,000,000       5,000,000


                                                      
      Marketable investment securities                                  10,812,895       7,173,037


                                                      
      Accrued interest income                                               15,611          38,514


                                                      
      Prepaid and other current assets                                     148,930         520,113




                                                      
      Total current assets                                              19,641,755      20,809,203




                                                         Property and equipment, net of accumulated
                                                          depreciation of
                                                            
            $1,132,422 and $1,124,700, respectively


                                                                                                      11,275                    18,997


                                                      
      Other assets                                                          23,753          23,753




                                                      
      Total assets                                                     $19,676,783     $20,851,953








     
              Liabilities and Stockholders' Equity





     Current liabilities:


                                                      
      Accounts payable                                                    $116,031        $671,280


                                                      
      Accrued expenses                                                     993,456         487,135


                                                      
      Debt - current portion                                             3,333,333       3,333,333


                                                      
      Total current liabilities                                          4,442,820       4,491,748




                                                      
      Debt - non-current portion                                         5,383,757       6,926,532




                                                      
      Total liabilities                                                  9,826,577      11,418,280







                                                      
      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; 24,729,700
                                                          and 21,737,196 issued 
            and 24,723,990 and
                                                          21,731,486 outstanding

                                                                                                                              2,473           2,174






                                                      
      Additional paid-in capital                                       154,600,442     147,533,019


                                                      
      Treasury stock at cost, 5,710 shares                                (40,712)       (40,712)


                                                         Accumulated other comprehensive income (loss)                          2,917           (963)


                                                      
      Accumulated deficit                                            (144,714,914)  (138,059,845)




                                                      
      Total stockholders' equity                                         9,850,206       9,433,673






                                                      
      Total liabilities and stockholders' equity                       $19,676,783     $20,851,953


                                                                                      
              
                LIPOCINE INC. AND SUBSIDIARIES


                                                                         
              Condensed Consolidated Statements of Operations and Comprehensive Loss


                                                                                                      
              (Unaudited)




                                                                         Three Months Ended June 30,                                                       Six Months Ended June 30,



                                                                                                2019                                                                             2018                   2019                         2018






     Revenues:


                            License revenue               
              $ -                                  
              $              -                                                  
     $ -                     $428,031


                            Total revenues                                                                                                                                                                   428,031






     Operating expenses:


                            Research and
                             development                     1,964,146                      1,482,378                                                                        3,913,466              2,859,905


                            General and
                             administrative                  1,386,457                      1,682,031                                                                        2,562,385              3,369,522



                            Total operating
                             expenses                        3,350,603                      3,164,409                                                                        6,475,851              6,229,427





                            Operating loss                 (3,350,603)                   (3,164,409)                                                                     (6,475,851)           (5,801,396)






     Other income (expense):


                            Interest and
                             investment income                 124,581                        120,403                                                                          249,846                230,585


                            Interest expense                 (204,575)                     (211,494)                                                                       (428,364)             (403,960)



                            Total other
                             expense, net                     (79,994)                      (91,091)                                                                       (178,518)             (173,375)




                            Loss before
                             income tax
                             expense                       (3,430,597)                   (3,255,500)                                                                     (6,654,369)           (5,974,771)





     Income tax expense                                                                                                                                                                        (700)                       (700)




                            Net loss                      $(3,430,597)                  $(3,255,500)                                                                    $(6,655,069)          $(5,975,471)





      Basic loss per share attributable to common stock                                 $(0.14)                                                                         $(0.15)               $(0.28)                     $(0.28)





      Weighted average common shares outstanding, basic                              24,591,419                                                                       21,264,539             23,990,552                   21,264,539



      Diluted loss per share attributable to common stock                               $(0.14)                                                                         $(0.15)               $(0.28)                     $(0.28)





      Weighted average common shares outstanding, diluted                            24,591,419                                                                       21,264,539             23,990,552                   21,264,539






     Comprehensive loss:


                            Net loss                      $(3,430,597)                  $(3,255,500)                                                                    $(6,655,069)          $(5,975,471)


                           Net unrealized
                             gain (loss) on
                             available-
                             for-sale
                             securities                          1,528                          8,043                                                                            3,880                (6,992)




                            Comprehensive
                             loss                         $(3,429,069)                  $(3,247,457)                                                                    $(6,651,189)          $(5,982,463)

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SOURCE Lipocine Inc.