from ms: Axiron net sales, as reported by Eli Lilly, for the...

from ms:
Axiron net sales, as reported by Eli Lilly, for the quarter ended 30 September 2014 totaled USD 36.3 million, down 23% sequentially and 11% year on year. However, on a year-to-date basis, sales of USD 122.9 million are broadly in line with previous corresponding period sales of USD 124.8 million. This highlights the underlying demand for the product despite the issues raised by the FDA related inquiry into safety of the testosterone therapy category as a whole. The FDA is expected to provide a definitive ruling on safety matter next month, which given the recent vote by its advisory committee, will most likely include more stringent labeling requirements for Eli Lilly. Axiron’s metered dose gel and applicator style delivery format represents a competitive advantage over recently launched generic injectable formulations which require return visits to the clinician for administration, and bodes well for growth longer term.
Our fair value estimate for no moat-rated Acrux remains unchanged at AUD 2.00 per share, and incorporates a shift of the USD 50 million milestone payment under the Eli Lilly agreement to fiscal 2016. This implies the shares are undervalued at current levels. Nonetheless we reiterate that our fair value uncertainty rating is very high given the high level of regulatory risk and the potential impact of an adverse ruling by the FDA on prescribing patterns for Axiron in the U.S. market.