Lipocine Announces Financial and Operational Results for the First Quarter 2017
May 08 2017 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced financial results for the first quarter ended March
31, 2017.
First Quarter and Recent Corporate
Highlights
• Announced completion of enrollment in both the dosing
validation (“DV”) and dosing flexibility (“DF”) studies for LPCN
1021. LPCN 1021 is an oral testosterone product candidate for
testosterone replacement therapy in adult males for conditions
associated with a deficiency or absence of endogenous testosterone,
also known as hypogonadism.
- Top-line results from both studies are expected in June
2017.
- Resubmission of the New Drug Application (“NDA”) for LPCN 1021
is planned for the third quarter of 2017.
• Received additional guidance from the FDA regarding the
pivotal Phase 3 clinical study design for LPCN 1107 which is being
developed for reducing the risk of preterm birth (“PTB”) in women
with singleton pregnancy who have a history of singleton
spontaneous PTB.
- Lipocine plans to submit the proposed Phase 3 protocol to the
FDA via a Special Protocol Assessment (“SPA”) in the second quarter
of 2017.
• Promoted Gregory Bass to Executive Vice President and Chief
Commercial Officer. Mr. Bass will be responsible for leading the
commercialization of Lipocine's product candidates, including its
testosterone replacement franchise.
“During 2017, we have made substantial progress in advancing our
product candidates in preparation for upcoming data disclosures and
planned regulatory filings,” said Dr. Mahesh Patel, Chairman,
President and CEO of Lipocine. “We plan to report top-line
results from the on-going LPCN 1021 studies in June and expect to
resubmit our NDA to the FDA in the third quarter of 2017. For
LPCN 1107, we are preparing to submit the proposed Phase 3 trial
design via an SPA in the second quarter of 2017.”
First Quarter 2017 Financial Results
Lipocine reported a net loss of $4.9 million, or $0.26 per
diluted share, for the first quarter ended March 31, 2017, compared
with a net loss of $7.0 million, or $0.38 per diluted share, in the
first quarter ended March 31, 2016.
Research and development expenses were $3.1 million in the first
quarter of 2017, compared with $2.7 million in the first quarter of
2016. The change was primarily due to an increase in contract
research organization costs in 2017 related to the on-going studies
for LPCN 1021 offset by a decrease in manufacturing costs for LPCN
1021 as well as decrease in personnel costs as a result of our 2016
restructurings.
General and administrative expenses were $1.8 million in the
first quarter of 2017, compared with $4.4 million in the first
quarter of 2016. The change was primarily due to a decrease in
business development, market research and pre-commercialization
activities related to LPCN 1021 as well as decrease in personnel
costs as a result of our 2016 restructurings.
As of March 31, 2016, Lipocine had cash, cash equivalents and
marketable investment securities of $26.8 million, compared with
cash and cash equivalents of $26.8 million as of December 31,
2016.
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
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-point in Phase 3 testing, which utilized 24-hour
pharmacokinetic data for dose adjustments, and is currently being
studied in two additional Phase 3 clinical trials. LPCN 1111,
a novel oral prodrug of testosterone, originated with 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, the potentially first oral
hydroxyprogesterone caproate product candidate indicated for the
prevention of recurrent preterm birth, 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.
LIPOCINE INC. AND SUBSIDIARIES |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ending March 31, |
|
|
|
|
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research
and development |
|
$ |
3,083,739 |
|
$ |
2,673,391 |
|
General and
administrative |
|
1,825,176 |
|
4,397,013 |
|
|
Total
operating expenses |
|
4,908,915 |
|
7,070,404 |
|
|
|
|
|
|
|
|
|
|
|
Operating
loss |
|
(4,908,915) |
|
(7,070,404) |
|
|
|
|
|
|
|
|
|
Other
income, net |
|
48,355 |
|
61,659 |
|
|
|
|
|
|
|
|
|
|
|
Loss before
income tax expense |
|
(4,860,560) |
|
(7,008,745) |
|
|
|
|
|
|
|
|
|
Income tax
expense |
|
(700) |
|
(700) |
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(4,861,260) |
|
$ |
(7,009,445) |
|
|
|
|
|
|
|
|
|
Basic loss
per share attributable to common stock |
|
$ |
(0.26) |
|
$ |
(0.38) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, |
|
18,711,239 |
|
18,251,905 |
basic |
|
|
|
|
|
|
Diluted
loss per share attributable to common stock |
|
$ |
(0.26) |
|
$ |
(0.38) |
|
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, diluted |
|
18,711,239 |
|
18,251,905 |
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
Net
loss |
|
$ |
(4,861,260) |
|
$ |
(7,009,445) |
|
|
Net
unrealized gain on available-for-sale securities |
|
2,707 |
|
35,795 |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(4,858,553) |
|
$ |
(6,973,650) |
|
|
|
|
|
|
|
|
|
|
LIPOCINE INC. AND SUBSIDIARIES |
|
Condensed Consolidated Balance
Sheets |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
|
|
|
2017 |
|
2016 |
|
|
|
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
6,936,511 |
|
$ |
5,560,716 |
|
|
|
Marketable
investment securities |
|
19,860,549 |
|
21,279,570 |
|
|
|
Accrued
interest income |
|
35,946 |
|
38,943 |
|
|
|
Prepaid and
other current assets |
|
262,039 |
|
329,548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current
assets |
|
27,095,045 |
|
27,208,777 |
|
|
|
|
|
|
|
|
|
|
|
Property
and equipment, net of accumulated depreciation of |
|
|
|
|
|
$1,099,803 and $1,092,710, respectively |
|
96,347 |
|
103,440 |
|
Other
assets |
|
30,753 |
|
30,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
27,222,145 |
|
$ |
27,342,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
853,510 |
|
$ |
245,915 |
|
|
|
Accrued
expenses |
|
1,491,448 |
|
1,080,254 |
|
|
|
|
|
Total current
liabilities |
|
2,344,958 |
|
1,326,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
2,344,958 |
|
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; 19,267,452 and 18,462,325 issued |
|
|
|
|
|
|
|
|
and
19,261,742 and 18,456,615 outstanding |
|
1,927 |
|
1,846 |
|
|
|
Additional
paid-in capital |
|
135,199,981 |
|
131,481,123 |
|
|
|
Treasury
stock at cost, 5,710 shares |
|
(40,712) |
|
(40,712) |
|
|
|
Accumulated
other comprehensive loss |
|
(5,786) |
|
(8,493) |
|
|
|
Accumulated
deficit |
|
(110,278,223) |
|
(105,416,963) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity |
|
24,877,187 |
|
26,016,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity |
|
$ |
27,222,145 |
|
$ |
27,342,970 |
|
|
|
|
|
|
|
|
|
|
CONTACT:
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
mb@lipocine.com
Investors:
Hans Vitzhum
Phone: (646) 597-6979
hans@lifesciadviors.com
Lipocine (NASDAQ:LPCN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Lipocine (NASDAQ:LPCN)
Historical Stock Chart
From Apr 2023 to Apr 2024