Lipocine Announces Financial and Operational Results for the Second Quarter and Six Months Ended June 30, 2018

Published: Aug 07, 2018

 

SALT LAKE CITY, Aug. 7, 2018 /PRNewswire/ -- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the three and six months ended June 30, 2018.

Second Quarter and Recent Corporate Highlights

  • Received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding the New Drug Application ("NDA") for TLANDO™, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
  • Dosed the first subject in the ambulatory blood pressure ("ABPM") clinical study for TLANDO. This study is being conducted to definitively characterize TLANDO's blood pressure effect, if any, and is expected to address the blood pressure related concern cited in the FDA's Complete Response Letter.
  • Completed a Post Action Meeting with the FDA on July 19th in which the deficiencies raised in the CRL were discussed and a path forward for NDA resubmission for the potential approval of TLANDO was clarified. The FDA provided specific feedback on potential resolution of each deficiency, including clinical design elements where appropriate.

"We continue to believe that, as an oral drug, TLANDO offers significant benefits to hypogonadal patients compared to topical gels and injections. Following receipt of the CRL we remain committed to working with the FDA to arrive on a path forward for the potential approval of TLANDO," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "We recently initiated an ambulatory blood pressure monitoring study, designed to address one of the concerns raised by the FDA, and we expect data from this study in the first quarter of 2019."

Second Quarter 2018 Financial Results

Lipocine reported a net loss of $3.3 million, or ($0.15) per diluted share, for the quarter ended June 30, 2018, compared with a net loss of $6.1 million, or ($0.31) per diluted share, in the quarter ended June 30, 2017.

Research and development expenses were $1.5 million in the quarter ended June 30, 2018, compared with $4.1 million in the quarter ended June 30, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs related to on-going clinical development of TLANDO as well as less contract manufacturing costs in 2018.

General and administrative expenses were $1.7 million in the quarter ended June 30, 2018, compared with $2.0 million in the quarter ended June 30, 2017. The decrease in general and administrative expenses was primarily due to decreased professional fees in 2018 associated with legal, intellectual property and commercial activities as well as decreased personnel, office and overhead costs.

As of June 30, 2018, the Company had cash, cash equivalents, and marketable securities of $20.1 million, compared to cash, cash equivalents, and marketable securities of $21.5 million at December 31, 2017. Additionally, as of June 30, 2018 we had $5.0 million of restricted cash.

Six Months Ended June 30, 2018 Financial Results

Lipocine reported a net loss of $6.0 million, or ($0.28) per diluted share, for the six months ended June 30, 2018, compared with a net loss of $11.0 million, or ($0.58) per diluted share, in the six months ended June 30, 2017.

Research and development expenses were $2.9 million in the six months ended June 30, 2018, compared with $7.2 million in the six months ended June 30, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs related to on-going clinical development of TLANDO, reduced personnel costs and less contract manufacturing costs for LPCN 1107 offset by an increase in outside services associated with the TLANDO BRUDAC meeting in January 2018.

General and administrative expenses were $3.4 million in the six months ended June 30, 2018, compared with $3.9 million in the six months ended June 30, 2017. The decrease in general and administrative expenses was primarily due to decreased personnel costs related to a reduced headcount in 2018. Additionally, professional fees decreased in 2018 associated with legal, intellectual property and commercial activities as well as decreased office and overhead costs.

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 TLANDO, 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. TLANDO received a Complete Response Letter from the FDA on May 8, 2018. 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 and the FDA review process relating to its product candidates, the timing of completion of clinical trials including the ABPM study for TLANDO, the path to approvability by the FDA of Lipocine's development programs, 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,

                                                                                                                                                        2018                                    2017
                                                                                                                                                        ----                                    ----

                                                                      Assets

    Current assets:

                                                             Cash and cash
                                                             equivalents                                                    $1,602,079                           $3,210,749

                                                            Restricted cash                                                  5,000,000                                    -

                                                             Marketable
                                                             investment
                                                             securities                                                     18,488,756                           18,257,321

                                                             Accrued interest
                                                             income                                                             46,687                               23,067

                                                             Litigation insurance
                                                             recovery                                                                -                           3,319,927

                                                             Prepaid and other
                                                             current assets                                                    113,250                              408,227


                                                                                       Total current assets                                       25,250,772                              25,219,291


    Property and equipment, net of accumulated depreciation
     of $1,115,811 and $1,121,080, respectively                               27,886                                             75,070

    Other assets                                                              23,753                                             30,753


                                                                                       Total assets                                              $25,302,411                             $25,325,114
                                                                                                                                                 ===========                             ===========



                                                                 Liabilities and
                                                                  Stockholders'
                                                                      Equity

    Current liabilities:

                                                            Accounts payable                                                  $406,540                             $598,070

                                                             Litigation
                                                             settlement payable                                                      -                           4,250,000

                                                            Accrued expenses                                                   886,980                            1,497,056

                                                             Debt -current
                                                             portion                                                         1,549,485                                    -

                                                                                       Total current liabilities                                   2,843,005                               6,345,126


    Debt - non-current portion                                             8,580,447                                                  -


                                                                                       Total liabilities                                          11,423,452                               6,345,126
                                                                                                                                                  ----------                               ---------



    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; 21,270,249
                                                             and 21,270,249 issued
                                                             and 21,264,539 and
                                                             21,264,539 outstanding                                2,127                                2,127

                                                             Additional paid-in
                                                             capital                                                       146,304,446                          145,423,012

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

                                                             Accumulated other
                                                             comprehensive loss                                               (11,608)                             (4,616)

                                                            Accumulated deficit                                          (132,375,294)                        (126,399,823)


                                                                                       Total stockholders' equity                                 13,878,959                              18,979,988
                                                                                                                                                  ----------                              ----------

                                                                                        Total liabilities and
                                                                                        stockholders' equity                                     $25,302,411                             $25,325,114
                                                                                                                                                 ===========                             ===========


 

 

 

                                                                                                                                         LIPOCINE INC. AND SUBSIDIARIES

                                                                                                                     Condensed Consolidated Statements of Operations and Comprehensive Loss

                                                                                                                                                   (Unaudited)


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

                                                                                                                         2018                                                                        2017                            2018                                 2017
                                                                                                                         ----                                                                        ----                            ----                                 ----


    Revenues:

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

                          Total revenues                                           -                                                                  -                                                       428,031                                    -
                                                                                 ---                                                                ---                                                       -------                                  ---


    Operating expenses:

                           Research and
                           development                           1,482,378                                           4,106,897                                                                   2,859,905                       7,190,636

                           General and
                           administrative                        1,682,032                                           2,033,721                                                                   3,369,522                       3,858,897


                           Total operating
                           expenses                              3,164,410                                           6,140,618                                                                   6,229,427                      11,049,533
                                                                 ---------                                           ---------                                                                   ---------                      ----------


                          Operating loss                       (3,164,410)                                        (6,140,618)                                                                (5,801,396)                   (11,049,533)
                                                                ----------                                          ----------                                                                  ----------                     -----------


    Other income (expense):

                           Interest and
                           investment income                       120,403                                              50,852                                                                     230,585                          99,208

                          Interest expense                       (211,494)                                                  -                                                                  (403,960)                              -


                           Total other
                           income
                           (expense), net                         (91,091)                                             50,852                                                                   (173,375)                         99,208


                           Loss before
                           income tax
                           expense                             (3,255,501)                                        (6,089,766)                                                                (5,974,771)                   (10,950,325)


    Income tax expense                                                                                                 -                                                                          -                          (700)                               (700)


                          Net loss                                       $(3,255,501)                                                       $(6,089,766)                                                  $(5,975,471)                       $(10,951,025)
                                                                         ===========                                                         ===========                                                    ===========                         ============


    Basic loss per share attributable to common stock                                                            $(0.15)                                                                    $(0.31)                        $(0.28)                             $(0.58)
                                                                                                                  ======                                                                      ======                          ======                               ======


    Weighted average common shares outstanding, basic                                                         21,264,539                                                                  19,372,625                      21,264,539                           19,043,759
                                                                                                              ==========                                                                  ==========                      ==========                           ==========

    Diluted loss per share attributable to common stock                                                          $(0.15)                                                                    $(0.31)                        $(0.28)                             $(0.58)
                                                                                                                  ======                                                                      ======                          ======                               ======


    Weighted average common shares outstanding, diluted                                                       21,264,539                                                                  19,372,625                      21,264,539                           19,043,759
                                                                                                              ==========                                                                  ==========                      ==========                           ==========


    Comprehensive loss:

                          Net loss                                       $(3,255,501)                                                       $(6,089,766)                                                  $(5,975,471)                       $(10,951,025)

                           Net unrealized gain
                           (loss) on
                           available-for-
                           sale securities              8,043                     5,174                                                             (6,992)                                                         7,881


                           Comprehensive
                           loss                                          $(3,247,458)                                                       $(6,084,592)                                                  $(5,982,463)                       $(10,943,144)
                                                                         ===========                                                         ===========                                                    ===========                         ============

 

 

 

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SOURCE Lipocine Inc.

 
 
Company Codes: NASDAQ-SMALL:LPCN
 

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