As of April 30, 2016, GSK beneficially owned approximately 28.3% of our outstanding capital stock (according to the 10-K filed after the close today)
a solid report!
The market too a cue from GSK's earnings report (Breo and Anoro sales a tad softer than expected) and sold INVA expecting a big miss. Today's report should reassure investors.
EPS beats on strong Vaccines/Consumer. Guidance upped.
We highlight key takeaways from GSK 1Q16 results: 1) EPS 19.8p beats consensus and
BofAMLe by 10% on sales 4% ahead. 2) Beat mostly driven by strong Vaccines (sales
11% ahead of consensus partly aided by order phasing and better
opinc beat versus BofAMLe) and Consumer (sales 6
opinc 35% ahead
on 17% margins vs our 13% est); 3) Guidance increased
-12% CER (constant exchange rate) EPS growth plus 8% tailwind vs prior
and 5% tailwind. Implies 3
-5% consensus upgrades in our view. Maintain
Buy for double digit EPS growth and 5.5% dividend yield.
Sentiment: Strong Buy
Cudkowicz, Gordon, Green and Perlmutter weren't in the BMRN panel last November. The other 6 participated in the Drisapersen panel. How that will play out is the million dollar question.....
Baird analyst Brian Skorney is incrementally positive on the FDA's move to include voting questions on Sarepta Therapeutic (NASDAQ: SRPT) eteplirsen.
The analyst called it a "shocking move.
"The final question will gauge panelists' read on the efficacy of the drug," he notes. "This leaves the door open for patient advocates to sway the panel on a definitive vote. Prepare for a wild ride. After years of ambiguity surrounding this review, we head into Monday expecting nothing more than to be surprised."
$SRPT bulls also emboldened by presence of clear-cut voting questions. These were absent from $BMRN panel. On to Monday!!
If Needham is right, SRPT at these levels is the bargain of the century!
Both Needham and Oppenheimer see this as a buying opportunity. We will know on monday if they are right!
Needham: We Are Buyers of Sarepta Therapeutics Inc (SRPT) on Yesterday’s Sell-Off
Jason Cohen, Editor — April 22, 2016, 7:17 AM EDT
Sarepta Therapeutics Inc (NASDAQ:SRPT) shares sank in Thursday’s trading session after the FDA released negative briefing documents regarding the company’s Duchenne muscular dystrophy drug, ahead of Monday’s AdComm review.
However, Chad Messer, an analyst with Needham & Co LLC, a New York investment firm, said he continues to view accelerated approval for eteplirsen as uncertain but possible, and remains buyer of Sarepta on yesterday’s sell-off.
Messer wrote, “The FDA released new briefing documents ahead of the rescheduled AdComm for eteplirsen. Reviewer skepticism for SRPT’s dystrophin data and clinical efficacy remains, even after both SRPT and top KOLs in the DMD community strongly rebutted previous FDA arguments. Given entrenched nature of the reviewers’ initial arguments and the likely role of personal egos, this doesn’t surprise us. While the rest of the market appears to be disappointed in the lack of reversal on the part of the reviewers, we are actually somewhat encouraged by the fact that the last speaker for the FDA will be Director Woodcock, as her tone would likely supersede that of the reviewers.”
Messer reiterated a Buy rating on Sarepta shares, with a price target of $53, which represents a potential upside of 381% from where the stock is currently trading.
From Barron's: The FDA advisory committee hearing Monday promises to be a dramatic event and probably the most widely attended hearing ever. Sarepta and the FDA will present their cases to the committee, and a block of two-and-a-half hours is set aside for public comment. Many patients and family members of boys with DMD are expected to speak passionately in favor of the drug, arguing that the drug is slowing the progression of the disease and clearly showing a clinical benefit.
The FDA is under enormous patient and political pressure to approve the drug. Reflecting this, a senior FDA official, Janet Woodcock, the head the agency’s Center for Drug Evaluation and Research, will testify at the committee hearing.
If eteplirsen doesn’t get accelerated approval in May, it will dim but not kill the drug’s chances for approval. Sarepta now is conducting a confirmatory Phase 3 trial, and some results are expected next year or in 2018. If those results are positive, Sarepta could approach the FDA again and seek approval. Accelerated approval is granted in cases of a high unmet medical need and can be based on more limited clinical trials than are normally required for drug approval.
The long Sarepta saga continues and the prospects for eteplirsen approval clearly are diminished. At the current price, investors are putting low odds on approval. What’s the downside? If approval is denied in May, the stock could fall into the high single digits. If eteplirsen accelerated approval is granted, however, the stock could trade at $60
Oppenheimer analyst Christopher Marai is maintaining his Outperform rating and $60 price target on Sarepta Therapeutic (NASDAQ: SRPT) despite the massive sell-off on the FDA released updated briefing documents for SRPT's Monday Adcom.
Marai commented, "FDA was mostly unchanged in its analysis, rebutting the addendum SRPT posted in response to prior briefing-documents. Four-year data did not appear to affect the FDA's analysis, and predictably, historical-control selection was questioned. We maintain that the data highlight eteplirsen's benefit and that in the absence of safety signals, any benefit, no matter how small, needs to be considered in light of minimal risk. We anticipate discussion of data at the panel is likely to be evaluated in voting questions that ask if data negatively/not-change/positively influence a view on SRPT's P2 dystrophin, 6MWT, LOA (p. 4) and safety findings. We believe data supports unchanged/positive conclusions. Weakness around these briefing docs is unsurprising as we highlighted in our April 5 note. Our view remains unchanged."
JP Morgan Says SOTP Valuation Suggests Upside To Current Valeant Levels, Maintains Overweight
Paul Quintaro , Benzinga Staff Writer
April 05, 2016 11:02am
Sentiment: Strong Buy
BMO says Valeant could be near 'significant inflection point' BMO Capital analyst Alex Arfaei says Valeant Pharmaceuticals could be on the verge of a "significant inflection point" after the company announced that its board committee has not identified any additional items that would require restatements beyond those required by matters previously disclosed. Valeant's financial misstatements so far do not support the fraud allegations, Arfaei tells investors in a research note, citing his firm's review. He believes the stock is undervalued relative to the company's underlying fundamentals. The analyst has a Market Perform on the shares, but his price target of $66 is well above the stock's current levels.
Sentiment: Strong Buy