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Monday, February 4, 2019

Gilead reports Q4 adjusted EPS $1.44, consensus $1.71

Reports Q4 revenue $5.795B, consensus $5.49B. Reports Q4 product sales $5.681B. Product sales for the fourth quarter of 2018 were $4.5 billion in the United States, $813 million in Europe and $398 million in other locations. Product sales for the fourth quarter of 2017 were $4.1 billion in the United States, $1.1 billion in Europe and $553 million in other locations.
https://thefly.com/landingPageNews.php?id=2858625

Gilead raises quarterly dividend by 11% to 63c per share

https://thefly.com/landingPageNews.php?id=2858626

UnitedHealth reports selection as one of 4 MCOs to adminster NC Medicaid program

The State of North Carolina, which is partnering with local health plans to improve people’s health and well-being and reduce health care costs, selected UnitedHealthcare Community Plan of North Carolina as one of four managed care organizations to administer its statewide Medicaid program, effective Nov. 1, 2019. “We are honored to work with the State of North Carolina to ensure Medicaid beneficiaries have access to personalized, cost-effective health care. We are committed to improve the overall health of Medicaid plan participants throughout North Carolina,” said Anita Bachmann, CEO, UnitedHealthcare Community Plan of North Carolina.
https://thefly.com/landingPageNews.php?id=2858615

Stephens remains bullish on Abiomed despite ‘Dear Doctor’ letter

Stephens analyst Chris Cooley reiterates an Overweight rating and $415 price target on Abiomed’s shares despite the recent issuance of a “Dear Doctor” letter related to the Impella RP. Specifically, the letter notes the FDA is evaluating post-approval study results for the RP which suggest a higher mortality rate for patients treated with the Impella RP versus what was noted in prior clinical studies, he adds. The analyst’s model estimates sales of the Impella RP will contribute about $48M to FY19 operating results and he points out that the Impella remains on the market and the company is working with the FDA to assess the post approval study data.

Medtronic: electromagnetic navigation allows earlier lung cancer diagnoses

A large, yearlong Medtronic study found its electromagnetic navigation system allowed bronchoscopes to better reach difficult areas of the lung and diagnose cancer earlier.
Specifically, the study found that 65% of the patients diagnosed with primary lung cancer were found to be in the earliest stages—with about half of lesions measuring less than 20 mm in diameter—at times when early detection can be critical to improving long-term outcomes.
“These data demonstrate that, for the first time, both academic and community-based care clinicians can safely obtain a diagnosis in small, peripheral lung lesions, and then stage and prepare for future treatment in a single minimally invasive procedure,” said study co-lead investigator Erik Folch, chief of the Complex Chest Disease Center at Massachusetts General Hospital.
While replicating real-world conditions, the study evaluated the diagnostic yield and complication rates of the med-tech giant’s Emprint ablation catheter and its superDimension navigation system for lung procedures and included long-term follow up of negative cases. The study’s results, published in the Journal of Thoracic Oncology, included 12 months of follow-up of 1,215 patients at 29 medical centers in the U.S.
The procedure was successfully completed in 94% of study patients and a navigation-assisted diagnosis was obtained in 73%. In addition, the procedure had lower complication rates.

Specifically, organ wall injuries causing a collapse of the lung, or pneumothorax, occurred in only 4.3% of patients, compared to previously published rates ranging between a fifth and a quarter of transthoracic needle biopsies, Medtronic said.
The superDimension system has received 510(k) clearance from the FDA as well as a CE Mark in Europe and has also been approved in Japan, Korea and China. The Emprint ablation catheter kit has a CE Mark but is not cleared in the U.S.
Medtronic is planning a prospective study in up to 30 patients to evaluate the safety and performance of bronchoscopic thermal ablation using the Emprint catheter when guided by the superDimension system.

Does Bristol-Myers Squibb’s new activist investor want to stall its Celgene buyout?

Analysts and investors have both expressed concerns over Bristol-Myers Squibb’s $74 billion Celgene deal agreement. And an activist may be joining that list.
Known agitator Starboard Value has taken a stake in the New Jersey drugmaker, Bloomberg’s sources say, though the size of that stake and the hedge fund’s plans are still unclear. A BMS spokeswoman declined to comment.
Bristol-Myers and Celgene agreed to tango early in the year, signing a mammoth deal they said would make a combined company a leader in oncology and immunology. But analysts have pressed Bristol on lower-than-expected revenue growth guidance it rolled out late last month.
One course of action Starboard may be angling for? A sale, Bloomberg Intelligence Sam Fazeli told the news service. “But there are only a very few companies that can actually do that,” he said. AbbVie, Pfizer and Novartis top the list, “but all these would require a lot of synergies to be accretive.”

At one time, analysts predicted Bristol’s sagging shares could make it a takeover target for rivals interested in getting their hands on its immuno-oncology assets. As recently as BMS’ fourth-quarter earnings call last week, analysts asked executives whether they did the Celgene deal to avoid an unwanted buyout bid.
But these days, there doesn’t seem to be a lot of interest in megamergers on the part of some of the most likely parties. Pfizer, who many thought could go after Bristol, has said repeatedly that it plans to stick to smaller bolt-on acquisitions.
AbbVie CEO Richard Gonzalez recently told investors that a “big deal” is “not something that we are contemplating.” And Celgene, which surveyed the landscape before inking its pact with Bristol, didn’t find much interest in megabuys, either; it approached just one other potential buyer that squarely turned it down.
“There has been activist involvement in Bristol over the past couple years that may have contributed to some changes at the company, but we would be surprised if activists are successful in pushing for a larger change, such as trying to get Bristol to sell itself,” Credit Suisse analyst Vamil Divan wrote in a Monday note to clients, adding that he and his colleagues continue to expect deal to close as planned.
Meanwhile, Starboard has been active in the pharma world over the last few years, most recently convincing Perrigo to jettison its prescription drugs business. Before getting involved with the Dublin drugmaker, it pressured California’s Depomed to go up for sale.

Allergan asks ITC to investigate new Botox rivals

Stat News reports