Lipocine Announces Financial And Operational Results For The Full Year Of 2016

SALT LAKE CITY, March 06, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial and operational results for the full year ended December 31, 2016.

• Initiated both a Dosing Validation (“DV”) Study and a Dosing Flexibility (“DF”) Study for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") 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 projected in the second quarter of 2017. 
• Received additional guidance regarding pivotal Phase 3 clinical study design from the FDA for LPCN 1107, a novel oral hydroxyprogesterone caproate ("HPC") product candidate that has been granted orphan drug designation by the FDA, in development for the proposed indication of reducing the risk of preterm birth ("PTB") in women with singleton pregnancy who have a history of singleton spontaneous PTB. The recent guidance received is in addition to feedback provided at the End of Phase 2 meeting with the FDA. Lipocine plans to submit the LPCN 1107 Phase 3 protocol to the FDA via a Special Protocol Assessment ("SPA") in the first half of 2017. 

"During the quarter and subsequent period, we have made significant progress on the development of both LPCN 1021 and LPCN 1107,” said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. “We currently expect this progress to continue in the near term, with top line results from our on-going LPCN 1021 studies and a SPA filing for LPCN 1107, both expected before mid-2017.”

Full Year 2016 Financial Results

Lipocine reported a net loss of $19.0 million, or $1.04 per diluted share, for the full year of 2016, compared with a net loss of $18.2 million, or $1.11 per diluted share, for the full year of 2015.

For the full year of 2016, research and development expenses were $8.1 million, compared with $12.6 million for the full year of 2015. The change was primarily due to decreased contract research organization and consultant costs of $3.8 million.  In addition, during the year ended December 31, 2015, we incurred a $2.3 million fee to file our NDA for LPCN 1021 with the FDA.  These decreases in 2016 were offset by an increase in validation and commercial batch manufacturing costs for LPCN 1021 in 2016 of $1.7 million

For the full year of 2016, general and administrative expenses were $10.4 million, compared with $5.8 million for the full year of 2015. The change was primarily due an increase of $2.0 million in personnel costs due primarily to increased salaries and stock-based compensation related to a higher average headcount in 2016, an increase of $1.2 million for pre-commercialization marketing and sales activities related to LPCN 1021, and an increase of $750,000 in legal costs for class action defense and patent interference.   

The full year of 2016 also included $0.7 million of restructuring costs.

As of December 31, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $26.8 million, compared with cash and cash equivalents of $44.8 million as of December 31, 2015.

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.