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Fly News Breaks for June 13, 2018
Jun 13, 2018 | 08:06 EDT
After HHS Secretary Alex Azar spoke at a two-hour Senate hearing, Morgan Stanley analyst David Risinger noted that Azar suggested that U.S. drug pricing needs to move to a system without rebates and said payments from drugmakers to PBMs should be eliminated. In listing four HHS actions that could hurt manufacturers, Risinger pointed out that Azar said he is interested in removing 100% cap on Medicaid rebates; he would like to adjust the Part D protected drug classes so that plans can extract rebates from manufacturers; HHS wants to require manufacturers to disclose drug list prices in TV ads; and HHS is focused on transitioning Part B to lower-priced private sector management. In summary, the analyst said that for drugmakers there was "no fire, but smoke signals worth noting." Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
Jul 17, 2018 | 06:49 EDT
Johnson & Johnson reports Q2 operational sales results increased 8.7% and the positive impact of currency was 1.9%. Domestic sales increased 9.4%. International sales increased 11.8%, reflecting operational growth of 7.9% and a positive currency impact of 3.9%. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.3%, domestic sales increased 5.7% and international sales increased 6.8%.
Jul 17, 2018 | 06:45 EDT
Lowers FY18 revenue guidance to $80.5B-$81.3B from $81M-$81.8M, consensus $81.47B.
Jul 17, 2018 | 06:24 EDT
Mizuho analyst Difei Yang last night initiated coverage of Xeris Pharmaceuticals with a Buy rating and $26 price target. The company offers a potentially superior solution for the treatment of severe hypoglycemia compared to the standard of care - Eli Lilly's (LLY) glucagon emergency kit, Yang told investors in a research note. The analyst sees a "significant growth opportunity" for the ready-to-use glucagon rescue pen as more healthcare professionals prescribe an easier option for patients with diabetes at risk of severe hypoglycemia.
Jul 17, 2018 | 05:15 EDT
Genentech, a member of the Roche Group, announced that the Phase III CAPSTONE-2 study assessing the safety and efficacy of baloxavir marboxil in people at high risk of complications from the flu met the study's primary objective, and showed superior efficacy in the primary endpoint of time to improvement of influenza symptoms versus placebo. The Centers for Disease Control and Prevention defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease - for these people, the flu can lead to hospitalization or even death. Baloxavir marboxil also demonstrated superior efficacy compared to placebo and oseltamivir for important secondary endpoints, including reducing the time that the virus continued to be released and reducing viral levels in the body. Furthermore, baloxavir marboxil significantly reduced the incidence of influenza-related complications compared to placebo. Baloxavir marboxil was well tolerated and no safety signals were identified. Full results from the CAPSTONE-2 study will be presented at upcoming medical meetings. Baloxavir marboxil was discovered and developed by Shionogi, and is sold in Japan under the trade name Xofluza
Jul 16, 2018 | 10:40 EDT
Notable companies reporting before tomorrow's open, with earnings consensus, include Johnson & Johnson (JNJ), consensus $2.07... UnitedHealth (UNH), consensus $3.04... Goldman Sachs (GS), consensus $4.66... Prologis (PLD), consensus 38c... Progressive (PGR), consensus $1.10... Omnicom Group (OMC), consensus $1.55.
Jul 16, 2018 | 07:35 EDT
Morgan Stanley analyst David Lebowitz initiated AvroBio (AVRO) with an Overweight rating and $37 price target, noting that its a unique gene therapy company that has human clinical data for one of its programs at the time of its initial public offering. He points to Novartis' (NVS) recent acquisition of AveXis for $8.7B, or an 88% premium, as an illustration of the substantial interest in and valuation premium put into many names in the gene therapy space.
Jul 16, 2018 | 07:10 EDT
The company said, "Idera (IDRA) ended Q1, with cash and cash equivalents totaling $107.5M, which as of the reporting of Q1 is anticipated to fund current operations into 3Q19. Subsequently, Idera announced an agreement with Bristol-Myers Squibb (BMY) related to the funding of ipilimumab for the ILLUMINATE-301 trial, the cost of which we had previously budgeted for in our cash forecast, and as a result of the terminated merger with BioCryst Pharmaceuticals (BCRX) we also received $6M in related fees. These two items have not yet been reflected in the Company's financial runway and will be updated as the results of Q2 are reported. In addition, as previously disclosed on June 20, 2018, shareholders voted to approve giving the Board of Directors discretion to implement a reverse stock split of not less than 1-for-4 and not more than 1-for-8."
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