Arena Pharma: Sell-Side Squawks
Updated with a Bank of America Merrill Lynch research note published this morning.
SAN DIEGO (TheStreet) -- Everyone, it seems, has strong opinions about Arena Pharmaceuticals (ARNA) and its obesity drug lorcaserin. As investors wait for FDA to make an approval decision on Wednesday, here's a summary of what Wall Street's sell-side analysts have been saying recently about Arena and lorcaserin (with ancillary comments about obesity drug competitor Vivus (VVUS).)
Bank of America Merrill Lynch
Last Arena note: June 26
Rating/price target: Underperform/$5
Analyst comments:
"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
Analyst comments:
"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.
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