Repros Therapeutics Inc (RPRX): Safety Data, Balance Sheet On Track

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Ascendiant Capital Markets analyst Keay Nakae rates Repros Therapeutics Inc (NASDAQ:RPRX) as a Buy as the company reports its Q413 results.

Repros’ Q4 2013 Results

Repros Therapeutics Inc (NASDAQ:RPRX) has reported its Q4 2013 results. The Company is pre-revenue. Operating expense was $5.8 MM, which was a decrease of $0.8 MM compared to a year ago, reflecting decreased clinical trial activity during the quarter. The net loss was ($7.1 MM) or EPS of ($0.31). Cash used for operations in the quarter was approximately $6 MM. Androxal Update: The Company met with the FDA in February to discuss its planned NDA filing for Androxal. As a result of that meeting, the Company believes that data from the two Phase 3 studies (ZA-304 and ZA-305) that it is currently conducting, which compare Androxal head-to-head against Androgel, will be critical in the Agency’s review of whether the product should be approved for the treatment of secondary hypogonadism. Topline data from these studies is expected to be reported in Q4 of this year. The NDA filing is now expected to be submitted around the end of this year.

Safety Data Appears to Be on Track

After the meeting with the FDA, the Company understands that the safety of Androxal will stand on its own merits during NDA review and therefore believes that its plan to provide safety data from its ZA-300 clinical study, its ZA-303 safety study of bone mineral density, along with the safety data from all of its other Phase 2 and Phase 3 studies, is still adequate. In a recent update of the ZA-300 study, the Company reported that no new safety issues were identified. Proellex Update: The Company has two shots on goal for Proellex, its drug for the treatment of uterine fibroids and endometriosis. The Company is currently enrolling patients in a 60 subject Phase 2 study to evaluate low dose oral Proellex to treat endometriosis. The Company expects to complete enrollment in this study in the second half of 2014. The Company also expects to commence enrollment in a 90 patient Phase 2b study of vaginal Proellex to treat uterine fibroids in Q2 of this year.

Balance Sheet

Repros Therapeutics Inc (NASDAQ:RPRX) ended the quarter with $76 MM of cash. We estimate a cash burn of $30 MM in 2014.

Adjustments to Our Estimates

Our estimates for 2014 and 2015 of no revenue in either year, and GAAP EPS of ($1.44), and ($1.05) respectively, are unchanged. We Reiterate Our BUY Recommendation and Are Increasing Our 12 Month PT to $23 for Repros Therapeutics Inc (NASDAQ:RPRX): The ZA-304 and ZA-305 Phase 3 studies of will now serve as the primary basis for approval of Androxal for this indication. If eventually approved, we believe that these studies will also be valuable in supporting the advantages of Androxal, and could further support potential labeling claims for superiority of Androxal over Androgel. Our 12 month PT is calculated using an NPV analysis.

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