Lipocine Announces Financial and Operational Results for the First Quarter Ended March 31, 2018


[STK] NASDAQ-SMALL:LPCN

[IN] HEA MTC PHA

[SU] ERN TRI

— WITH PHOTO — TO BUSINESS, AND HEALTH EDITORS:

Lipocine Announces Financial and Operational Results for the First

Quarter Ended March 31, 2018

SALT LAKE CITY, May 7, 2018 /PRNewswire/ — Lipocine Inc. (NASDAQ:

LPCN), a specialty pharmaceutical company, today announced financial

results for the first quarter ended March 31, 2018.

First Quarter and Recent Corporate Highlights

— The Company received $10 million through a Loan and Security

Agreement with Silicon Valley Bank (“SVB Loan”).

— The Bone, Reproductive and Urologic Drugs Advisory Committee

(“BRUDAC”) of the U.S. Food and Drug Administration (“FDA”) met to

discuss the New Drug Application (“NDA”) for TLANDOT, Lipocine’s oral

testosterone product candidate for the proposed indication of

testosterone replacement therapy in adult males for conditions

associated with a deficiency of endogenous testosterone, also known as

hypogonadism.

— BRUDAC voted six in favor and thirteen against the acceptability of

the overall benefit/risk profile to support approval of TLANDO as a

testosterone replacement therapy (“TRT”).

— The Company and the other defendants entered into a memorandum of

understanding to settle the purported securities class action

litigation captioned In re Lipocine Inc. Securities Litigation.

— The Company initiated a phlebotomy clinical study under the TLANDO

investigational new drug (“IND”) Application to confirm no ex-vivo

conversion of testosterone undecanoate to testosterone.

— The Company submitted a draft protocol for an ambulatory blood

pressure monitoring (“ABPM”) clinical study to the FDA for review

under the TLANDO IND.

— The FDA’s assigned Prescription Drug User Fee Act (“PDUFA”) goal

date for the TLANDO NDA is May 8, 2018.

“We look forward to learning the FDA outcome on our PDUFA goal date

for TLANDO.  We continue to believe that as an oral drug TLANDO offers

significant benefits to patients compared to topical gels and

injections. These benefits include overcoming the inadvertent

testosterone transference risk to children and partners that exist

with topical gels,” said Dr. Mahesh Patel, Chairman, President and

Chief Executive Officer of Lipocine.

First Quarter 2018 Financial Results

Lipocine reported a net loss of $2.7 million, or ($0.13) per diluted

share, for the quarter ended March 31, 2018, compared with a net loss

of $4.9 million, or ($0.26) per diluted share, in the quarter ended

March 31, 2017.

License revenues were $428,000 during the three months ended March 31,

2018, compared to no revenue being received during the three months

ended March 31, 2017.  License revenue relates to royalty payments

received from Spriaso, LLC under a licensing agreement for the cough

and cold field.

Research and development expenses were $1.4 million in the quarter

ended March 31, 2018, compared with $3.1 million in the quarter ended

March 31, 2017. The decrease in research and development expenses was

primarily due to reduced contract research organization costs for

TLANDO and lower personnel costs offset by increased outside service

costs primarily related to the TLANDO BRUDAC meeting in January 2018

and increased contract manufacturing costs for LPCN 1107.

General and administrative expenses were $1.7 million in the quarter

ended March 31, 2018, compared with $1.8 million in the quarter ended

March 31, 2017. The decrease in general and administrative expenses

was primarily due to decreased personnel costs and overhead costs

offset by increased professional fees related to legal, intellectual

property and commercial activities.

As of March 31, 2018, the Company had cash, cash equivalents, and

marketable securities of $27.8 million, compared to cash, cash

equivalents, and marketable securities of $21.5 million at December

31, 2017. In the event TLANDO is not approved by the FDA on or prior

to May 31, 2018, the SVB loan requires $5.0 million of cash to be

restricted and held as cash collateral until such time as TLANDO is

approved by the FDA.

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 was well

tolerated and met the primary efficacy end-points in Phase 3 testing

with twice daily dosing and is currently under FDA review.  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, is currently in Phase 2 testing and has been granted

orphan drug designation by the FDA. 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 FDA review process relating to its product

candidates, the expected timing of the FDA review process related to

our resubmitted NDA, 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 that the FDA will determine there are deficiencies

in our resubmitted NDA, 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)

March 31, December 31,

Assets 2018 2017

Current assets:

Cash and cash equivalents $              8,561,313 $     3,210,749

Marketable investment securities 19,201,374 18,257,321

Accrued interest income 47,249 23,067

Litigation insurance recovery 3,566,649 3,319,927

Prepaid and other current assets 247,979 408,227

     Total current assets 31,624,564 25,219,291

Property and equipment, net of accumulated depreciation of $1,111,366 and $1,121,080, respectively 32,331 75,070

Other assets 23,753 30,753

     Total assets $            31,680,648 $   25,325,114

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable $                388,356 $        598,070

Litigation settlement payable 4,250,000 4,250,000

Accrued expenses 305,064 1,497,056

Debt – current portion 1,340,514 –

     Total current liabilities 6,283,934 6,345,126

Debt – non-current portion 8,724,452 –

     Total liabilities 15,008,386 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 145,850,292 145,423,012

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

Accumulated other comprehensive loss (19,651) (4,616)

Accumulated deficit (129,119,794) (126,399,823)

     Total stockholders’ equity 16,672,262 18,979,988

     Total liabilities and stockholders’ equity $            31,680,648 $   25,325,114

LIPOCINE INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ending March 31,

2018 2017

Revenues:

License revenue $    428,031 $              –

Total revenues 428,031 –

Operating expenses:

Research and development 1,377,527 3,083,739

General and administrative 1,687,490 1,825,176

Total operating expenses 3,065,017 4,908,915

Operating loss (2,636,986) (4,908,915)

Other income (expense):

Interest and investment income 110,181 48,355

Interest expense (192,466) –

Total other income (expense), net (82,285) 48,355

Loss before income tax expense (2,719,271) (4,860,560)

Income tax expense (700) (700)

Net loss $(2,719,971) $(4,861,260)

Basic loss per share attributable to common stock $        (0.13) $        (0.26)

Weighted average common shares outstanding, basic 21,264,539 18,711,239

Diluted loss per share attributable to common stock  $        (0.13) $        (0.26)

Weighted average common shares outstanding, diluted 21,264,539 18,711,239

Comprehensive loss:

Net loss $(2,719,971) $(4,861,260)

Net unrealized gain (loss) on available-for-sale securities (15,035) 2,707

Comprehensive loss $(2,735,006) $(4,858,553)

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SOURCE Lipocine Inc.

-0- 05/07/2018

/CONTACT: Morgan Brown, Executive Vice President & Chief Financial Officer, Phone: (801) 994-7383, mb@lipocine.com, or Investors, Hans Vitzhum, Phone: (646) 597-6979, hans@lifesciadvisors.com

/Photo: https://mma.prnewswire.com/media/627654/Lipocine—Logo.jpg

/Web Site: http://www.lipocine.com

(NASDAQ-SMALL:LPCN) /

CO: Lipocine Inc.

ST: Utah

IN: HEA MTC PHA

SU: ERN TRI

PRN

— LA86856 —

0000 05/07/2018 12:00:00 EDT http://www.prnewswire.com



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