Aegerion is a biopharmaceutical company focused on the development and commercialization of treatments for patients with severe lipid disorders. Its lead therapeutic is Juxtapid, an oral small-molecule inhibitor of MTP approved in the U.S. and currently pending regulatory review in the E.U. for treatment of patients with homozygous familial hypercholesterolemia (HoFH).
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Following a top- and bottom-line beat, AEGR provided metrics on the first ~15 weeks of the Juxtapid launch and described the “accelerated” trajectory of 75 U.S. and ex-U.S. named-patients on drug (Brazil and Turkey) and scripts (>185 to date; ~9/week at week 6; ~13/week now). As a result, we continue to believe that guidance of 250-300 patients on drug by YE13 and $15M-$25M in FY13 revenue is conservative, but model for 273 and $25.5M, respectively (we assume 33 patients on drug entering April, 75 entering May [no additions] and 95 in June) until we get clarity on the trajectory post Q1. In addition, we believe a key overhang from AMGN’s AMG 145 data has been removed given the ~19% LDL reduction (vs. 40% for Juxtapid) as it is not a key competitive threat. We look to a positive CHMP decision in Q2/E.U. approval in mid-2013 as the next catalysts.
Launch details are all favorable: AEGR is seeing a higher-than-expected interest from cardiologists who have “a meaningful” number of HoFH patients, and is optimizing marketing for these practices. AEGR also indicated greater confidence on the 3K HoFH patients in the U.S. given launch experience, and will provide dropout (“very encouraging”) and compliance rates on future calls. On the payor front, AEGR has met with >100 payors and is surpassing internal pre-auth timeline metrics. The company is appealing negative payor decisions – rejections are due to paperwork or lack of payor policy. AEGR expects to give turnaround time for scripts on the Q2 call (guided to ~4-5 mo. in Jan).
E.U. approval on-track for mid-2013: AEGR likes the odds of E.U. approval (~60 days post-CHMP opinion in Q2). The company does not expect an oral explanation will be required and was pleased with the Scientific Advisory Group meeting (similar to FDA AdCom).
Q1 financials, 2013 guidance: Q1 GAAP EPS of $(0.64) was better than consensus of $(0.71) and CGe of $(0.73) due to higher revenue ($1.2M vs. consensus of $630K) and lower GAAP R&D expense ($5.8M vs. CGe of $8.0M). AEGR exited Q1 with $140.7M and provided OpEx guidance (ex-stock-based comp) of $95M-$105M (we model for $96.2M)
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