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Wednesday, May 1, 2019

Medidata downgraded earlier to Neutral from Buy at Dougherty

https://thefly.com/landingPageNews.php?id=2901109

Alnylam shares reacting to increased expense guidance, says Piper Jaffray

Piper Jaffray analyst Edward Tenthoff noted that Alnylam reported Q1 Onpattro sales of $26M, which beat his $14M estimate and the consensus forecast of $19M. Despite the Onpattro sales beat and trends that he said underscore the drug’s “best-in-class profile,” Tenthoff said the stock is reacting negatively to management having increased their 2019 expense guidance. The analyst, who raised his 2019 Onpattro sales forecast to $127M from $82M, keeps an Overweight rating and $142 price target on Alnylam. Near 11 am ET, Alnylam shares are down 4% to $85.49.

Allergan CEO Saunders wins vote to keep chairman role

Allergan Plc shareholders have voted down a nonbinding proposal that sought an immediate split of the roles of chairman and chief executive, with 61.3 percent of shareholders backing Chairman and CEO Brent Saunders.
Billionaire investor David Tepper’s hedge fund Appaloosa LP made the proposal, arguing that drugmaker Allergan currently has a questionable business strategy and excessive pay for executives.
Proxy advisory firms backed keeping the current structure. However, Appaloosa’s success in attracting the votes of a substantial minority highlights the displeasure of many investors.
The voting results represent 85.9 percent of shares eligible to vote, Allergan said in a statement on Wednesday.
Allergan, under pressure to rescue the company’s falling stock price, launched a review of its strategy last year. But that review is only likely to result in the sale of its relatively small infectious disease unit.
Appaloosa has voiced its discontent with the results of the review, and has called for a breakup or sale of the company, citing recent clinical failures such as that of its depression treatment rapastinel.
In an effort to fend off Appaloosa, Allergan agreed in March to split the chairman and CEO roles, but only at its next leadership change. Saunders, 49, has no plans to step down, a source close to the company told Reuters then.
The company has also replaced more than half of its board since 2017.
Saunders put together the current version of Allergan through a series of deals to roll up several pharmaceutical companies in 2014, and has run the company since then.
He built his reputation as a dealmaker, but he has struggled since Pfizer Inc walked away from a $160 billion deal to buy Allergan in 2016. Allergan’s shares have lost nearly half their value since then.
The company’s shares closed at $147 on the New York Stock Exchange on Tuesday.
Reuters on Tuesday had reported that enough votes had been cast for Allergan to prevail against Appaloosa.

Pulse Biosciences, Inc. (PLSE) Misses Q1 EPS by 5c

Pulse Biosciences, Inc. (NASDAQ: PLSE) reported Q1 EPS of ($0.49), $0.05 worse than the analyst estimate of ($0.44).
Recent Corporate Developments
  • Pre-market Notification (510(k)) submitted to the U.S. Food and Drug Administration (FDA) for its proprietary CellFX System seeking clearance for commercial use in common dermatologic procedures to remove general benign lesions including Sebaceous Hyperplasia, a common but difficult-to-treat facial lesion and Seborrheic Keratosis, a common benign pigmented lesion. This afternoon we received an additional information (“AI”) letter request from FDA, and the FDA among other things is questioning the adequacy of the predicate device provided in the 510(k). Responding to this request will add time and require additional testing, inclusive of clinical trials. In consideration of the above we are presently evaluating an alternative approach, the De Novo process approach, which would also likely require additional time, testing and clinical studies. At the end of the day the De Novo approach may be in the best interest of Pulse Biosciences. We will update on this important matter no later than the upcoming Annual Meeting of Stockholders scheduled for May 16, 2019.
  • Mitchell Levinson, a well-seasoned entrepreneur and executive in the aesthetic procedure market, appointed to the Board of Directors.
  • Podium presentations by key opinion leaders in aesthetic dermatology speaking to the novel mechanism of action of the CellFX System and the positive results from our clinical studies in Sebaceous Hyperplasia and Common Warts at the American Academy of Dermatology Annual Meeting and the American Society for Laser Medicine and Surgery Annual Conference.
  • Continued progress in active feasibility studies including Common Warts, Back Acne and Basal Cell Carcinoma.
“At Pulse Biosciences we remain focused on commercializing our CellFX System in aesthetic dermatology and we are pleased with our progress towards this goal in Q1,” said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer.

Tandem Diabetes price target raised to $78 from $67 at Piper Jaffray

Piper Jaffray analyst JP Kim raised his price target on Tandem Diabetes to $78 and kept his Overweight rating after its Q1 results “far exceeded” expectations, saying the company is “clearly” capturing market share in in the pump market. The analyst also cites the momentum of Tandem Diabetes based on the management’s indication that only about a quarter of the company’s sales were in January, anticipating no change in the positive “competitive dynamic” of its market.

Teladoc Q1 results rebuffed multiple share overhangs, says Piper Jaffray

Piper Jaffray analyst Sean Wieland believes Teladoc’s “solid” Q1 results rebuffed the “multiple overhangs” on the stock. Strong utilization trends brushed off the concerns over the weak flu season and management committed to receiving the NCQA accreditation, Wieland tells investors in a research note. He sees new or expansion opportunities for the company across United, Aetna, Tricare, and the Medicare Advantage markets. As such, the analyst reiterates an Overweight rating on the shares with an $86 price target.

United Therapeutics reports Q1 EPS $3.58, consensus $2.78

Reports Q1 revenue $362.6M, consensus $335.43M.