Total Monthly Retail Data August-2016 + SunTrust Flash Note
V
TRx: 78,534 {vs 70,792; +10.94%} – Sector +7.65% -- ATH
NRx: 30,981 {vs 27,348; +13.28%} – Sector +9.76% -- ATH
L
TRx: 9,879 {vs 9,326; +5.93%}
NRx: 3,739 {vs 3,675; +1.74%}
Gen L
TRx: 271,700 {vs 254,400; +6.80%}
NRx: 100,370 {vs 92,060; +9.03%}
Monthly Retail TRx Market Share: 21.81% vs 21.16% --- ATH
Monthly Retail NRx Market Share: 22.93% vs 22.22% --- ATH
SUNTRUST FLASH NOTE
As Expected, REDUCE-IT Continues as Planned
REDUCE-IT next interim look expected in mid-2017
REDUCE-IT CV Outcomes study to continue as planned
AMRN announced that the independent data monitoring committee (DMC) for its REDUCE-IT outcomes study completed its review of the first pre-specified interim efficacy. As we expected, the independent DMC recommended that the trial continue as planned without modification. As per the study protocol, the first interim efficacy analysis was conducted after attainment of ~60% of the total target 1,612 primary cardiovascular (CV) events, & in order for the trial to stop early, the results would have had to show a very highly statistically significant benefit vs. placebo (p < 0.0076), which we didn’t expect to occur. Amarin remains blinded to the interim analysis & ongoing results of the REDUCE-IT study until after the study is stopped at either the next interim analysis in mid-2017 or at the final analysis. AMRN expects REDUCE-IT to attain ~80% of total target events in the first half of 2017, with the second pre-specified interim efficacy analysis anticipated by mid-2017. The criteria for early stop at the 80% target is less rigorous than the 60% interim criteria (early stop at 80% is triggered if p < 0.022), but still materially more onerous than the p < 0.05 criterion required for statistical significance. As such, we expect the DMC to recommend that REDUCE-IT continues until attainment of 100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of results in 2018. The REDUCE-IT trial design is modeled after nine previous outcomes trials for statins. We believe that Amarin will showcase the REDUCE-IT trial design in a peer-reviewed scientific journal [possibly the New England Journal of Medicine (NEJM)] in the near-term. AMRN indicated in its 2Q16 earnings call that the timing of the publication depends on the trial’s Principal Investigators & journal peer review. The REDUCE-IT trial is an important catalyst for AMRN, since it could contribute to meaningful expansion of the Vascepa label and commercial opportunity in patients with elevated triglycerides treated with statins. We see upside to our Vascepa 2016E sales estimate of $120M vs. Street’s $120M.
Vascepa TRx trends point to upside to our 3Q16E/2016E estimates
Our analysis of Vascepa TRx/NRx trends as reported by IMS Health (IMS, $29.86, Neutral, Sandy Draper) leads us to believe there is upside to our 3Q16E revenue estimate of $30.0M (+41% YoY). As of 9/2/2016, rolling 4- week adjusted TRx’s are ~69K, up +55% YoY, with TRx’s & NRx’s up in high 40% to low 60% range (YoY) since the beginning of 3Q16 as ANCHOR & JELIS promotions continue to volume growth. The robust Vascepa volume trends, along with the +6% price increase taken by AMRN at YE15, point to upside to our 3Q16 revenue estimate ($30M, +41% YoY). If these positive trends persist in 2H16, they could place upward pressure on AMRN’s $112M - $125M net product revenue projection for full-year 2016 (we model $120M in FY16 Vascepa revenue, above AMRN’s mid-point and in-line with the Street net product estimate).
