Full Press Release Details
Third Quarter 2019 Financial and Operational Results
LAKE CITY, November 12, 2019 - Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company,
today announced financial results for the third quarter and nine months ended September 30, 2019, and provided a corporate update.
Third Quarter and Recent Corporate
"During the third quarter, we
continued to advance our pipeline, with important milestones achieved," said Dr. Mahesh Patel, Chairman, President and Chief
Executive Officer of Lipocine. "We are excited to continue enrolling subjects in the ongoing LPCN 1144 LiFT clinical
study and look forward to participating in the TLANDO Post Action meeting with FDA to discuss a potential path forward for
the approval of TLANDO while reserving our right to request for formal dispute resolution," said Dr. Mahesh Patel.
Third Quarter Ended September 30,
2019 Financial Results
Lipocine reported a net loss of $3.1
million, or ($0.12) per diluted share, for the quarter ended September 30, 2019, compared with a net loss of $2.5 million, or ($0.12)
per diluted share, in the quarter ended September 30, 2018.
License revenue was $165,000 during the three months ended September
30, 2019 compared to no license revenue being recognized during the three months ended September 30, 2018. License revenue in 2019
relates to royalty payments received from Spriaso, LLC ("Spriaso") under a licensing agreement in the cough and cold
Research and development expenses were $1.7 million for the
quarter ended September 30, 2019, compared with $1.4 million for the quarter ended September 30, 2018. The increase in research
and development expenses was primarily due to increases in outside service costs related to the ramping up of the LPCN 1144 LiFT
Phase 2 clinical study and increases in other research and development costs, offset by decreased contract research organization
and outside consulting costs for TLANDO in connection with the completion of the ABPM study and filing of the NDA and a decrease
in personnel costs. The decrease in personnel costs primarily relate to decreased stock compensation expense which resulted from
the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon the approval
of TLANDO (previously estimated to vest in the fourth quarter of 2019). The decrease in stock-based compensation expense was offset
by increased salaries and other personnel expenses.
General and administrative expenses
were $1.4 million for the quarter ended September 30, 2019, compared with $0.9 million for the quarter ended September 30, 2018.
The increase in general and administrative was primarily due to an increase in legal fees mainly due to the lawsuit filed against
Clarus for patent infringement and increases in other general and administrative expenses, offset by a decrease in personnel costs
attributable to the reversal of stock-based compensation expense recorded for the expected vesting of restricted stock units upon
the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019).
As of September 30, 2019, the Company had unrestricted cash,
cash equivalents and marketable securities aggregating $11.5 million, compared to $15.3 million at December 31, 2018. Additionally,
as of September 30, 2019 and December 31, 2018 the Company had $5.0 million of restricted cash, which is required to be maintained
as cash collateral under the Loan and Security Agreement with Silicon Valley Bank until TLANDO is approved by the FDA.
Nine Months Ended September 30,
2019 Financial Results
Lipocine reported a net loss of $9.7
million, or ($0.40) per diluted share, for the nine months ended September 30, 2019, compared with a net loss of $8.4 million,
or ($0.40) per diluted share, in the nine months ended September 30, 2018.
License revenue was $165,000 during the nine months ended September
30, 2019 compared to license revenue of $428,000 during the three months ended September 30, 2018. License revenue in both 2019
and 2018 relates to royalty payments received from Spriaso under a licensing agreement in the cough and cold field.
Research and development expenses were
$5.6 million for the nine months ended September 30, 2019, compared with $4.3 million for the nine months ended September 30, 2018.
The increase in research and development expenses was primarily due to increases in the following costs: 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 LPCN 1144 LiFT Phase 2
clinical study, increased outside contract research organization costs related to TLANDO XR (LPCN 1111), increases in miscellaneous
other research and development expenses and increased personnel costs. These cost increases were offset by a decrease in personnel
costs attributable primarily to the reversal of stock-based compensation expense recorded for the expected vesting of restricted
stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019) and decreased contract manufacturing
costs for LPCN 1107.
General and administrative expenses
were $4.0 million for the quarter ended September 30, 2019, compared with $4.3 million for the quarter ended September 30, 2018.
The decrease in general and administrative was primarily due to decreased personnel costs, including decreased salaries and benefits
due to the elimination of our commercial sales and marketing team in 2018, a decrease in severance compensation, and a net decrease
in stock-based compensation mainly due to reversal of stock-based compensation expense recorded for the expected vesting of restricted
stock units upon the approval of TLANDO (previously estimated to vest in the fourth quarter of 2019) and increases in other general
and administrative expenses. These decreases in personnel costs and other general and administrative expenses were offset by increases
in legal fees mainly due to the lawsuit filed against Clarus for patent infringement and increases in corporate insurance.
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 TLANDO, LPCN 1144, TLANDO XR (LPCN 1111), LPCN 1148 and LPCN 1107 development programs. TLANDO, a novel oral
prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal
men and received a Complete Response Letter from the U.S. Food and Drug Administration on November 8, 2019. LPCN 1144, a differentiated
oral product of bioidentical testosterone, is currently undergoing Phase 2 clinical testing in biopsy confirmed NASH patients
and 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 has completed Phase 2 testing. LPCN 1148 is a unique oral testosterone
product targeted to treat NASH cirrhosis. 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 expectation that it will continue the LiFT Phase 2 clinical study,
future discussions and actions with the FDA related to TLANDO, 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) 994-7383
Phone: (617) 535-7743
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Balance Sheets |
| (Unaudited) |
| September 30, | December 31, | |||||||
| 2019 | 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,664,508 | $ | 8,077,539 | ||||
| Restricted cash | 5,000,000 | 5,000,000 | ||||||
| Marketable investment securities | 4,880,876 | 7,173,037 | ||||||
| Accrued interest income | 10,854 | 38,514 | ||||||
| Prepaid and other current assets | 754,504 | 520,113 | ||||||
| Total current assets | 17,310,742 | 20,809,203 | ||||||
| Property and equipment, net of accumulated depreciation of | ||||||||
| $1,136,283 and $1,124,700, respectively | 7,415 | 18,997 | ||||||
| Other assets | 23,753 | 23,753 | ||||||
| Total assets | $ | 17,341,910 | $ | 20,851,953 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,360,446 | $ | 671,280 | ||||
| Accrued expenses | 540,954 | 487,135 | ||||||
| Debt - current portion | 3,333,333 | 3,333,333 | ||||||
| Total current liabilities | 5,234,733 | 4,491,748 | ||||||
| Debt - non-current portion | 4,601,837 | 6,926,532 | ||||||
| Total liabilities | 9,836,570 | 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; 25,033,482 and 21,737,196 issued | ||||||||
| and 25,027,772 and 21,731,486 outstanding | 2,503 | 2,174 | ||||||
| Additional paid-in capital | 155,318,402 | 147,533,019 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive income (loss) | 261 | (963 | ) | |||||
| Accumulated deficit | (147,775,114 | ) | (138,059,845 | ) | ||||
| Total stockholders' equity | 7,505,340 | 9,433,673 | ||||||
| Total liabilities and stockholders' equity | $ | 17,341,910 | $ | 20,851,953 |
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Statements of Operations and Comprehensive Loss |
| (Unaudited) |
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| License revenue | $ | 164,990 | $ | - | $ | 164,990 | $ | 428,031 | ||||||||
| Total revenues | 164,990 | - | 164,990 | 428,031 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 1,713,417 | 1,422,919 | 5,626,883 | 4,282,823 | ||||||||||||
| General and administrative | 1,427,261 | 930,137 | 3,989,645 | 4,299,659 | ||||||||||||
| Total operating expenses | 3,140,678 | 2,353,056 | 9,616,528 | 8,582,482 | ||||||||||||
| Operating loss | (2,975,688 | ) | (2,353,056 | ) | (9,451,538 | ) | (8,154,451 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and investment income | 98,988 | 112,561 | 348,833 | 343,145 | ||||||||||||
| Interest expense | (183,500 | ) | (218,577 | ) | (611,864 | ) | (622,537 | ) | ||||||||
| Total other expense, net | (84,512 | ) | (106,016 | ) | (263,031 | ) | (279,392 | ) | ||||||||
| Loss before income tax expense | (3,060,200 | ) | (2,459,072 | ) | (9,714,569 | ) | (8,433,843 | ) | ||||||||
| Income tax expense | - | - | (700 | ) | (700 | ) | ||||||||||
| Net loss | $ | (3,060,200 | ) | $ | (2,459,072 | ) | $ | (9,715,269 | ) | $ | (8,434,543 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.12 | ) | $ | (0.12 | ) | $ | (0.40 | ) | $ | (0.40 | ) | ||||
| Weighted average common shares outstanding, basic | 24,911,908 | 21,266,639 | 24,301,045 | 21,265,247 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.12 | ) | $ | (0.12 | ) | $ | (0.40 | ) | $ | (0.40 | ) | ||||
| Weighted average common shares outstanding, diluted | 24,911,908 | 21,266,639 | 24,301,045 | 21,265,247 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (3,060,200 | ) | $ | (2,459,072 | ) | $ | (9,715,269 | ) | $ | (8,434,543 | ) | ||||
| Net unrealized gain (loss) on marketable investment securities | (2,656 | ) | 7,755 | 1,224 | 763 | |||||||||||
| Comprehensive loss | $ | (3,062,856 | ) | $ | (2,451,317 | ) | $ | (9,714,045 | ) | $ | (8,433,780 | ) |