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ALKS

Alkermes

$35.71

(0.00%)

09:47
11/30/18
11/30
09:47
11/30/18
09:47

Leerink sees commercial headwinds for Alkermes schizophrenia drug

Alkermes' Enlighten-2 Phase 3 trial for ALKS-3831, which met the co-primary endpoints, is enough to support approval, although the level of benefit was lower than expected, Leerink analyst Marc Goodman told investors yesterday in a research note. The Phase 3 data had "several weak points" when compared to the Phase 2 that could be headwinds for the commercial success of the schizophrenia drug, the analyst writes in a research note partially titled "Now Comes the Hard Part." As a result, Goodman reduced his ALKS-3831 peak non-risk-adjusted sales forecast in 2031 from $650M to $500M, yielding a sum-of-the-parts valuation of $5 per share for the asset. The analyst worries that Alkermes management believes, and is planning to spend as if, ALKS-3831 will be a $1B-plus blockbuster. Goodman keeps a Market Perform rating on Alkermes with a $36 price target.

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ALKS Alkermes
$35.71

(0.00%)

11/29/18
GSCO
11/29/18
NO CHANGE
Target $49
GSCO
Neutral
Goldman says questions remain for Alkermes' schizophrenia drug
Goldman Sachs analyst Terence Flynn said a number of outstanding questions remain for ALKS 3831, Alkermes' pipeline schizophrenia drug, after it achieved both co-primary endpoints in the Phase 3 ENLIGHTEN-2 trial. He wonders about the clinical meaningfulness of weight gain attenuation in the eyes of physicians and payors and has questions about Type 2 diabetes risk, Flynn tells investors following the company's report of the trial results. Flynn keeps a Neutral rating with a $49 price target on shares of Alkermes.
11/29/18
PIPR
11/29/18
NO CHANGE
Target $40
PIPR
Neutral
Alkermes data support approval, but usage looks limited, says Piper Jaffray
Piper Jaffray analyst Danielle Brill believes this morning's Phase 3 data from Alkermes support approval of schizophrenia drug ALKS 3831. However, while the drug certainly mitigates the weight gain effects associated with olanzapine, "the overall clinical relevance is still unclear to us," Brill tells investors in a research note. She points out that according to key opinion leaders, the detrimental metabolic effects of olanzapine are more concerning than the associated weight gain. And with no details on metabolic findings included in this morning's data, the analyst is "skeptical" that ALKS 3831 showed any benefit on these parameters. As such, Brill believes the data support approval of the drug but that usage "will be limited to a small subset of patients." The analyst keeps a Neutral rating on Alkermes with a $40 price target. The stock in late morning trading is up 62c to $37.50.
11/29/18
STFL
11/29/18
NO CHANGE
STFL
Hold
Stifel sees Alkermes trading modestly higher on 'decent' schizophrenia data
Stifel analyst Paul Matteis views this morning's ALKS 3831 Phase III schizophrenia data as a seven on a scale of one to 10. Most importantly, the drug showed a solid benefit on "weight gain outliers," a well-documented medical problem that represents a major drawback for olanzapine in the real world, Matteis tells investors in a research note. However, he adds that while ALKS 3831 reduced the odds that a patient would gain at least 10% of their body weight by 40%, the magnitude of the effect size was lesser than the Phase 2 study. Further, patients on the drug still gained a "decent amount of weight, plausibly more than one might observe on other atypical antipsychotics outside of olanzapine," says Matteis. He expects the stock to trade modestly higher today on the Phase 3 results. The data are "decent/solid," though not a "game changer," says the analyst. He sees the drug garnering "some use at the right price." Matteis keeps a Hold rating on Alkermes. The stock in premarket trading is down 28c to $36.88.
11/13/18
LEER
11/13/18
INITIATION
Target $36
LEER
Market Perform
Alkermes initiated with a Market Perform at Leerink
Leerink analyst Marc Goodman started Alkermes with a Market Perform and $36 price target as he initiates Neuroscience space with a Positive View. The analyst believes the Neuroscience sector is experiencing a "renaissance" as multiple new agents and mechanisms are coming up the pipeline across major therapeutic areas, the number of clinical studies is growing nicely, and the FDA is friendly to innovation in this space, companies are getting smarter about speed-to-market strategies and selecting niche sub-populations to focus on for initial product approvals, payer pushback on usage is much lower than in other categories, and physicians are enthusiastic about new agents. Regarding Alkermes, Goodman believes ALKS-5461 will be stopped by the company based on its mixed efficacy data, opioid concerns, and most importantly, the negative feedback from the FDA's AdCom. Additionally, he believes that expectations are too high for ALKS3831.

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