Full Press Release Details
Financial and Operational Results for the Second Quarter and Six
Months Ended June 30, 2017
SALT LAKE CITY, UT, August 7, 2017
- Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced financial results for the
three and six months ended June 30, 2017.
Second Quarter and Recent Corporate
"We are pleased with our accomplishments
and progress in the second quarter with LPCN 1021 and LPCN 1111, our oral testosterone replacement therapies, and LPCN 1107,
our oral alternative for the prevention of preterm birth," said Dr. Mahesh Patel, Chairman, President and Chief Executive
Officer of Lipocine. "We believe that the data from the DV study validates our "no titration" dosing regimen
and addresses the FDA concerns identified in our Complete Response Letter. We are targeting NDA resubmission during August 2017
and consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men with the potential to both improve patient
compliance and eliminate the risk of testosterone transference."
Second Quarter Ended June 30, 2017
Lipocine reported a net loss of $6.1
million, or ($0.31) per diluted share, for the second quarter ended June 30, 2017, compared with a net loss of $5.8 million, or
($0.32) per diluted share, in the second quarter ended June 30, 2016.
Research and development expenses were
$4.1 million in the second quarter ended June 30, 2017, compared with $2.6 million in the second quarter ended June 30, 2016. The
increase in research and development expenses year over year was primarily due to an increase in contract research organization
costs of $2.3 million for LPCN 1021 for the conduct of the DV and the DF clinical studies offset by a decrease in technical batch
manufacturing costs for LPCN 1021 of $747,000 and decreased personnel costs of $26,000. Personnel costs decreased as a result of
the restructurings that took place in July 2016 and October 2016.
General and administrative expenses
were $2.0 million in the second quarter ended June 30, 2017, compared with $3.2 million in the second quarter ended June 30, 2016.
The decrease in general and administrative expenses year over year was primarily due to a decrease of $1.0 million for business
development, market research and pre-commercialization activities related to LPCN 1021, as well as decreases in travel and personnel
costs. Personnel costs decreased as a result of the restructurings that took place in July 2016 and October 2016.
As of June 30, 2016, Lipocine had cash,
cash equivalents and marketable investment securities of $27.8 million, compared with cash and cash equivalents of $26.8 million
as of December 31, 2016.
Six Months Ended June 30, 2017 Financial
Lipocine reported a net loss of $11.0
million, or ($0.58) per diluted share, for the six months ended June 30, 2017, compared with a net loss of $12.8 million, or ($0.70)
per diluted share, in the six-month period ended June 30, 2016.
Research and development expenses were
$7.2 million in the six months ended June 30, 2017, compared with $5.2 million in the six months ended June 30, 2016. The increase
in research and development expenses in the six months ended June 30, 2017 was primarily due to an increase in contract research
organization costs of $3.7 million for LPCN 1021 for the conduct of the DV and DF clinical studies offset by a decrease in technical
batch manufacturing costs for LPCN 1021 of $1.5 million and decreased personnel costs.
General and administrative expenses
were $3.9 million in the six months ended June 30, 2017, compared with $7.6 million in the six months ended June 30, 2016. The
decrease year over year was primarily due to a decrease of $2.0 million for business development, market research and pre-commercialization
activities related to LPCN 1021, as well as decreases in legal fees related to patent litigation, travel expenses and personnel
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 LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a novel oral
prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal
men. LPCN 1021 was well tolerated and met the primary efficacy end-points in Phase 3 testing with twice daily dosing. 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, plans related to clinical trials, the possible outcome and
timing of such clinical trials, the expected timing of clinical trial results or any related FDA review process, 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, advance regulatory developments
and requirements, risks related to the FDA approval process, 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.
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (646) 597-6979
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Statements of Operations and Comprehensive Loss |
| (Unaudited) |
| Three Months Ending June 30, | Six Months Ending June 30, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,106,897 | $ | 2,567,701 | $ | 7,190,636 | $ | 5,241,092 | ||||||||
| General and administrative | 2,033,721 | 3,247,419 | 3,858,897 | 7,644,432 | ||||||||||||
| Total operating expenses | 6,140,618 | 5,815,120 | 11,049,533 | 12,885,524 | ||||||||||||
| Operating loss | (6,140,618 | ) | (5,815,120 | ) | (11,049,533 | ) | (12,885,524 | ) | ||||||||
| Other income, net | 50,852 | 55,009 | 99,208 | 116,668 | ||||||||||||
| Loss before income tax expense | (6,089,766 | ) | (5,760,111 | ) | (10,950,325 | ) | (12,768,856 | ) | ||||||||
| Income tax expense | - | - | (700 | ) | (700 | ) | ||||||||||
| Net loss | $ | (6,089,766 | ) | $ | (5,760,111 | ) | $ | (10,951,025 | ) | $ | (12,769,556 | ) | ||||
| Basic loss per share attributable to common stock | $ | (0.31 | ) | $ | (0.32 | ) | $ | (0.58 | ) | $ | (0.70 | ) | ||||
| Weighted average common shares outstanding, basic | 19,372,625 | 18,251,683 | 19,043,759 | 18,251,794 | ||||||||||||
| Diluted loss per share attributable to common stock | $ | (0.31 | ) | $ | (0.32 | ) | $ | (0.58 | ) | $ | (0.70 | ) | ||||
| Weighted average common shares outstanding, diluted | 19,372,625 | 18,251,683 | 19,043,759 | 18,251,794 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (6,089,766 | ) | $ | (5,760,111 | ) | $ | (10,951,025 | ) | $ | (12,769,556 | ) | ||||
| Net unrealized gain on available-for-sale securities | 5,174 | 3,051 | 7,881 | 38,846 | ||||||||||||
| Comprehensive loss | $ | (6,084,592 | ) | $ | (5,757,060 | ) | $ | (10,943,144 | ) | $ | (12,730,710 | ) |
| LIPOCINE INC. AND SUBSIDIARIES |
| Condensed Consolidated Balance Sheets |
| (Unaudited) |
| June 30, | December 31, | |||||||
| 2017 | 2016 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,631,174 | $ | 5,560,716 | ||||
| Marketable investment securities | 11,194,270 | 21,279,570 | ||||||
| Accrued interest income | 13,479 | 38,943 | ||||||
| Prepaid and other current assets | 88,638 | 329,548 | ||||||
| Total current assets | 27,927,561 | 27,208,777 | ||||||
| Property and equipment, net of accumulated depreciation of | ||||||||
| $1,106,895 and $1,092,710, respectively | 89,255 | 103,440 | ||||||
| Other assets | 30,753 | 30,753 | ||||||
| Total assets | $ | 28,047,569 | $ | 27,342,970 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,113,789 | $ | 245,915 | ||||
| Accrued expenses | 1,786,150 | 1,080,254 | ||||||
| Total current liabilities | 2,899,939 | 1,326,169 | ||||||
| Total liabilities | 2,899,939 | 1,326,169 | ||||||
| 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; 20,587,308 and 18,462,325 issued | ||||||||
| and 20,581,598 and 18,456,615 outstanding | 2,059 | 1,846 | ||||||
| Additional paid-in capital | 141,554,883 | 131,481,123 | ||||||
| Treasury stock at cost, 5,710 shares | (40,712 | ) | (40,712 | ) | ||||
| Accumulated other comprehensive loss | (612 | ) | (8,493 | ) | ||||
| Accumulated deficit | (116,367,988 | ) | (105,416,963 | ) | ||||
| Total stockholders' equity | 25,147,630 | 26,016,801 | ||||||
| Total liabilities and stockholders' equity | $ | 28,047,569 | $ | 27,342,970 |