Repros Therapeutics Inc.’s share price has been on a declining trend ever since the company received guidance from the U.S. Food and Drug Administration (FDA) related to the Androxal development program on Oct 22, 2013. In view of the guidance, Repros now expects to submit the new drug application (NDA) to the FDA in the fourth quarter of 2014. Earlier, the company had planned on submitting the NDA in mid-2014 with potential launch in 2015.
Investors reacted negatively to the delay in the potential approval of Repros. The stock price of Repros fell significantly since then. Overall, the stock lost 35.5% since the announcement. The release of the third quarter 2013 results did not revive investor confidence in the stock with barely any reversal in trends.
Repros reported third quarter 2013 loss of 26 cents per share, narrower than the year-ago loss of 30 cents per share and the Zacks Consensus Estimate of loss of 33 cents. The narrower loss was due to an increase in the number of shares.
The company’s revenue for the third quarter of 2013 was $0.3 million as compared to $0.1 million in the year-ago period. The entire revenues came from interest income.
In the third quarter of 2013, general and administrative expenses decreased 16% to $1.2 million due to lower stock based compensation. Research and development expenses shot up 53% year over year to $4.8 million, reflecting higher pipeline investment.
Androxal, the advanced pipeline candidate at Repros, is being evaluated for the treatment of secondary hypogonadism. Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.’s (ABBV - Free Report) AndroGel.
On Jun 25, 2013, the company completed a public offering of 4,312,500 shares at a price of $19.00 per share. Net proceeds from the transaction, approximately $76.8 million, boosted Repros’ cash balance which jumped to $81.8 million in Sep 30, 2013 from $24.2 in Dec 31, 2012.
Repros currently carries a Zacks Rank #3 (Hold). We expect investor focus to remain on Androxal updates.
However, companies like Actelion Ltd. and AMAG Pharmaceuticals Inc. (AMAG - Free Report) look more attractive with a Zacks Rank #1 (Strong Buy).