Last Arena note: June 26
Rating/price target: Underperform/$5
"Is prolactin-mediated cancer really a non-human risk? Several posters and oral presentations at the Endocrinology conference in recent days were focused on the relationship between prolactin levels and various cancers. Recall that Arena hypothesized that the fibroadenoma mammary tumors in lorcaserin-treated rats were due to elevated prolactin levels, which has previously been considered a rat-specific mechanism and not a human risk. The data presented at ENDO and summarized below could reinforce the view among some scientists that there is a causal link between prolactin and human cancers. We believe it is more than likely that the FDA will issue a Complete Response Letter for locaserin by the 6/27 decision date in order to develop risk mitigation plans or to collect more data such as from additional carcinogenicity studies."
From a May 11 note: "Our risk adjusted sales estimate for lorcaserin in 2017 is $530mn, which is below our $900mn and $1.8bn respective risk-adjusted sales estimates for Orexigen's Contrave and Vivus' Qnexa, driven largely by relatively efficacy differences."
Arena's first profitable year: Net income of $6 million in 2014. BMO Capital Markets
Last Arena note: June 25
Rating/price target: Market perform/$10
"We are reducing our rating on ARNA to MARKET PERFORM from OUTPERFORM , but maintaining our $10 price target. With ARNA shares trading at our target price we believe the stock is fully valued and pricing in timely approval, absence of REMS and low burden of monitoring. Upside potential to our $1.6B global peak sales estimate in 2020 and to our 2017 US sales estimate of $550M is difficult to ascertain, in advance of approval, labeling review and early-market trends, but we would highlight incremental $0.14 EPS for every $100M in incremental sales in our 2017 valuation year. Downside risk to nonapproval is low, in our opinion; however, with 17 of 23 panel members recommending regular monitoring for valvulopathy and with 9 of 23 specifically recommending a REMS or regular ECHO monitoring, downside risk to estimates could emerge." KEY POINTS
"In reviewing the transcript from the May 10, 2012, EMDAC panel meeting it is clear that the majority of panel members viewed the benefit-risk profile of lorcaserin as favorable but that a majority was also concerned regarding heart valve risk. To the extent that timing of lorcaserin approval, final labeling and ultimate commercial potential could be affected by FDA's view toward heart valve risk, we believe that it is instructive to review key panel comments around the rationale for the positive vote and monitoring recommendations. We would note that in total 17 of 23 EMDAC panel members recommended some form of heart valve monitoring with 9 of 23 panel members recommending a REMS or routine ECHO monitoring."
Arena's first profitable year: Net income of $27 million in 2015.