Full Press Release Details
First Quarter 2019 Financial and Operational Results
SALT LAKE CITY, May 8, 2019 -
Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the quarter ended March
31, 2019, and provided a corporate update.
First Quarter and Recent Corporate
"We achieved important milestones
in Lipocine's most advanced clinical programs during the first quarter of 2019, and in recent weeks," said Dr. Mahesh
Patel, Chairman, President and Chief Executive Officer of Lipocine. Dr. Patel further stated, "With the successful completion
of the ABPM study for TLANDO, we look forward to resubmitting our NDA for TLANDO in May 2019. We announced positive 16-week results
from the Liver Fat Study of LPCN 1144 and have received clearance from the FDA to initiate a Phase 2 clinical study of LPCN 1144
in patients with biopsy confirmed NASH."
First Quarter Ended March 31, 2019
Lipocine reported a net loss of $3.2
million, or ($0.14) per diluted share, for the quarter ended March 31, 2019, compared with a net loss of $2.7 million, or ($0.13)
per diluted share, in the quarter ended March 31, 2018.
Research and development expenses were
$1.9 million for the quarter ended March 31, 2019, compared with $1.4 million for the quarter ended March 31, 2018. The increase
in research and development expenses was primarily due to increased contract research organization costs for TLANDO in connection
with the ABPM Study, offset by decreases in outside service costs primarily related to the January 2018 TLANDO BRUDAC meeting,
decreases in contract manufacturing costs related to LPCN 1107, and decreases in personnel costs.
General and administrative expenses
were $1.2 million for the quarter ended March 31, 2019, compared with $1.7 million for the quarter ended March 31, 2018. The decrease
in general and administrative expenses was primarily due to decreased personnel costs, decreased professional fees offset by an
increase in other administrative costs related to overhead.
As of March 31, 2019, the Company had
unrestricted and restricted cash, cash equivalents and marketable securities aggregating $22.5 million, compared to $20.3 million
at December 31, 2018. The $5.0 million of restricted cash, cash equivalents and marketable securities becomes unrestricted upon
approval of TLANDO by the FDA.
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, LPCN 1111 and LPCN 1107. TLANDO, a novel
oral prodrug of testosterone comprised of testosterone undecanoate, is designed to help restore normal testosterone levels in
hypogonadal men. LPCN 1144, an oral product of bioidentical testosterone comprised of testosterone undecanoate, recently completed
a proof-of-concept clinical study demonstrating the potential utility in the treatment of NASH. 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 timing
of completion of clinical trials, 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.
For further information:
Executive Vice President & Chief
Phone: (801) 519-4090
Phone: (617) 535-7743
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
| March 31, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,222,103 | $ | 8,077,539 | ||||
| Restricted cash | 5,000,000 | 5,000,000 | ||||||
| Marketable investment securities | 9,300,338 | 7,173,037 | ||||||
| Accrued interest income | 16,369 | 38,514 | ||||||
| Prepaid and other current assets | 411,409 | 520,113 | ||||||
| Total current assets | 22,950,219 | 20,809,203 | ||||||
| Property and equipment, net of accumulated depreciation of $1,128,561 and $1,124,700, respectively | 15,136 | 18,997 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 22,989,108 | $ | 20,851,953 | ||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 517,725 | $ | 671,280 | ||||
| Accrued expenses | 426,186 | 487,135 | ||||||
| Debt - current portion | 3,333,333 | 3,333,333 | ||||||
| Total current liabilities | 4,277,244 | 4,491,748 | ||||||
| Debt - non-current portion | 6,160,170 | 6,926,532 | ||||||
| Total liabilities | 10,437,414 | 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; 24,580,663 and 21,737,196 issued and 24,574,953 and 21,731,486 outstanding | 2,458 | 2,174 | ||||||
| Additional paid-in capital | 153,872,876 | 147,533,019 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive income (loss) | 1,389 | (963 | ) | |||||
| Accumulated deficit | (141,284,317 | ) | (138,059,845 | ) | ||||
| Total stockholders' equity | 12,551,694 | 9,433,673 | ||||||
| Total liabilities and stockholders' equity | $ | 22,989,108 | $ | 20,851,953 |
LIPOCINE INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
and Comprehensive Loss
| Three Months Ended March 31, | ||||||||
| 2019 | 2018 | |||||||
| Revenues: | ||||||||
| License revenue | $ | - | $ | 428,031 | ||||
| Total revenues | - | 428,031 | ||||||
| Operating expenses: | ||||||||
| Research and development | 1,949,321 | 1,377,527 | ||||||
| General and administrative | 1,175,927 | 1,687,490 | ||||||
| Total operating expenses | 3,125,248 | 3,065,017 | ||||||
| Operating loss | (3,125,248 | ) | (2,636,986 | ) | ||||
| Other income (expense): | ||||||||
| Interest and investment income | 125,265 | 110,181 | ||||||
| Interest expense | (223,789 | ) | (192,466 | ) | ||||
| Total other expense, net | (98,524 | ) | (82,285 | ) | ||||
| Loss before income tax expense | (3,223,772 | ) | (2,719,271 | ) | ||||
| Income tax expense | (700 | ) | (700 | ) | ||||
| Net loss | $ | (3,224,472 | ) | $ | (2,719,971 | ) | ||
| Basic loss per share attributable to common stock | $ | (0.14 | ) | $ | (0.13 | ) | ||
| Weighted average common shares outstanding, basic | 23,383,008 | 21,264,539 | ||||||
| Diluted loss per share attributable to common stock | $ | (0.14 | ) | $ | (0.13 | ) | ||
| Weighted average common shares outstanding, diluted | 23,383,008 | 21,264,539 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (3,224,472 | ) | $ | (2,719,971 | ) | ||
| Net unrealized gain (loss) on available-for-sale securities | 2,352 | (15,035 | ) | |||||
| Comprehensive loss | $ | (3,222,120 | ) | $ | (2,735,006 | ) |