Full Press Release Details
Financial and Operational Results for the Three and Nine Months Ended September 30, 2018
SALT LAKE CITY, UT, November 7,
2018 - Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company,
today announced financial results for the three and nine months ended September 30, 2018.
Third Quarter and Recent Corporate
"We continue to believe there
is a path forward for TLANDO and anticipate a resubmission of our NDA for TLANDO in the first half of 2019 based on results from
on-going clinical studies," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. "We
are also excited about our new product candidate, LPCN 1144, for NASH and look forward to receiving clinical trial results in the
near term that will further support the use of an oral androgen for this important indication."
Three Months Ended September 30,
2018 Financial Results
Lipocine reported a net loss of $2.5
million, or ($0.12) per diluted share, for the three months ended September 30, 2018, compared with a net loss of $4.7 million,
or ($0.22) per diluted share, for the three months ended September 30, 2017.
Research and development expenses were
$1.4 million for the three months ended September 30, 2018, compared with $2.0 million for the three months ended September 30,
2017. The decrease in research and development expenses year over year was primarily due to reduced contract manufacturing organization
costs for TLANDO and LPCN 1107 and reduced personnel costs, offset by increased contract research organization costs for TLANDO
for the ABPM study. We expect research and development costs to increase through the first quarter of 2019 while we conduct the
ABPM study for TLANDO and complete the POC liver imaging study for LPCN 1144.
General and administrative expenses
were $930,000 for the three months ended September 30, 2018, compared with $2.7 million for the three months ended September 30,
2017. The decrease in general and administrative expenses year over year was primarily due to lower professional fees related to
legal, intellectual property and commercial activities as well as decreased personnel costs related to reduced headcount.
As of September 30, 2018, the Company
had unrestricted cash, cash equivalents, and marketable securities of $16.9 million, compared to cash, cash equivalents, and marketable
securities of $21.5 million at December 31, 2017.
Nine Months Ended September 30,
2018 Financial Results
Lipocine reported a net loss of $8.4
million, or ($0.40) per diluted share, for the nine months ended September 30, 2018, compared with a net loss of $15.7 million,
or ($0.80) per diluted share, in the nine months ended September 30, 2017.
Research and development expenses were
$4.3 million for the nine months ended September 30, 2018, compared with $9.2 million for the nine months ended September 30, 2017.
The decrease in research and development expenses year over year was primarily due to reduced contract research organization costs
for TLANDO as the DV and DF studies were complete in 2017 while the ABPM study was being initiated in 2018, lower personnel costs,
and lower contract manufacturing costs for LPCN 1107. This was offset by increased outside service and other costs primarily related
to the Company's preparation for and participation in the meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
("BRUDAC") of the FDA related to TLANDO that was held in January 2018.
General and administrative expenses
were $4.3 million for the nine months ended September 30, 2018, compared with $6.6 million for the nine months ended September
30, 2017. The decrease in general and administrative expenses year over year was primarily due to decreased personnel costs related
to reduced headcount. Additionally, professional fees related to legal, intellectual property and commercial activities also decreased
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 four development programs TLANDO, LPCN 1144, 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 1144, an oral prodrug
of bioidentical testosterone, is being developed as a treatment of non-alcoholic steatohepatitis ("NASH") and is currently
being studied in two proof-of-concept clinical studies. 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 as well as ongoing LPCN 1144 clinical trials, 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
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (617) 535-7743
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,802,806 | $ | 3,210,749 | ||||
| Restricted cash | 5,000,000 | - | ||||||
| Marketable investment securities | 12,077,016 | 18,257,321 | ||||||
| Accrued interest income | 29,892 | 23,067 | ||||||
| Litigation insurance recovery | - | 3,319,927 | ||||||
| Prepaid and other current assets | 728,482 | 408,227 | ||||||
| Total current assets | 22,638,196 | 25,219,291 | ||||||
| Property and equipment, net of accumulated depreciation of $1,120,256 and $1,121,080, respectively | 23,442 | 75,070 | ||||||
| Other assets | 23,753 | 30,753 | ||||||
| Total assets | $ | 22,685,391 | $ | 25,325,114 | ||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 239,922 | $ | 598,070 | ||||
| Litigation settlement payable | - | 4,250,000 | ||||||
| Accrued expenses | 488,632 | 1,497,056 | ||||||
| Debt - current portion | 2,341,054 | - | ||||||
| Total current liabilities | 3,069,608 | 6,345,126 | ||||||
| Debt - non-current portion | 7,853,844 | - | ||||||
| Total liabilities | 10,923,452 | 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; 21,340,017 and 21,270,249 issued and 21,334,307 and 21,264,539 outstanding | 2,134 | 2,127 | ||||||
| Additional paid-in capital | 146,638,736 | 145,423,012 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (3,853 | ) | (4,616 | ) | ||||
| Accumulated deficit | (134,834,366 | ) | (126,399,823 | ) | ||||
| Total stockholders' equity | 11,761,939 | 18,979,988 | ||||||
| Total liabilities and stockholders' equity | $ | 22,685,391 | $ | 25,325,114 |
INC. AND SUBSIDIARIES
Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| Revenues: | ||||||||||||||||
| License revenue | $ | - | $ | - | $ | 428,031 | $ | - | ||||||||
| Total revenues | - | - | 428,031 | - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,422,919 | 2,046,533 | 4,282,823 | 9,237,169 | ||||||||||||
| General and administrative | 930,137 | 2,719,526 | 4,299,659 | 6,578,423 | ||||||||||||
| Total operating expenses | 2,353,056 | 4,766,059 | 8,582,482 | 15,815,592 | ||||||||||||
| Operating loss | (2,353,056 | ) | (4,766,059 | ) | (8,154,451 | ) | (15,815,592 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 112,561 | 65,811 | 343,145 | 165,018 | ||||||||||||
| Interest expense | (218,577 | ) | - | (622,537 | ) | - | ||||||||||
| Total other income (expense), net | (106,016 | ) | 65,811 | (279,392 | ) | 165,018 | ||||||||||
| Loss before income tax expense | (2,459,072 | ) | (4,700,248 | ) | (8,433,843 | ) | (15,650,574 | ) | ||||||||
| Income tax expense | - | - | (700 | ) | (700 | ) | ||||||||||
| Net loss | $ | (2,459,072 | ) | $ | (4,700,248 | ) | $ | (8,434,543 | ) | $ | (15,651,274 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.12 | ) | $ | (0.22 | ) | $ | (0.40 | ) | $ | (0.80 | ) | ||||
| Weighted average common shares outstanding, basic | 21,266,639 | 20,890,580 | 21,265,247 | 19,666,131 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.12 | ) | $ | (0.22 | ) | $ | (0.40 | ) | $ | (0.80 | ) | ||||
| Weighted average common shares outstanding, diluted | 21,266,639 | 20,890,580 | 21,265,247 | 19,666,131 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (2,459,072 | ) | $ | (4,700,248 | ) | $ | (8,434,543 | ) | $ | (15,651,274 | ) | ||||
| Net unrealized gain on available-for-sale securities | 7,756 | 79 | 763 | 7,960 | ||||||||||||
| Comprehensive loss | $ | (2,451,316 | ) | $ | (4,700,169 | ) | $ | (8,433,780 | ) | $ | (15,643,314 | ) |