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Thursday, June 6, 2019

Health Insurance Innovations acquires direct-to-consumer platform

Health Insurance Innovations (NASDAQ:HIIQ) has acquired TogetherHealth, a direct-to-consumer platform aimed at the “over 65” insurance market.
Under the terms of the deal, HIIQ paid ~$50M in cash plus 630K shares of Class A common stock. It also included a five-year earnout provision.
The transaction will add at least $10M to HIIQ’s 2019 non-GAAP EBITDA.
Updated 2019 guidance: revenues: $450M – 460M from $430M – 440M; non-GAAP EBITDA: $82M – 87M from $72M – 77M; non-GAAP EPS: $3.80 – 4.05 from $3.50 – 3.75.
The company has established a new $215M credit facility that includes a $150M term loan and a $65M revolver. The term loan will fund the refinancing of $65M of existing debt and the cash portion of the transaction.
Management will host a conference call this morning at 9:00 am ET to discuss the deal.
Shares are up 6% premarket on light volume.

AMA witness tells judge CVS-Aetna merger creates big competitive concerns

  • Neeraj Sood made the American Medical Association’s case against the CVS-Aetna merger on Tuesday as the first witness to testify at an evidentiary hearing before Judge Richard Leon of the U.S. District Court for the District of Columbia. Nood is health policy professor and vice dean for research at the University of Southern California Sol Price School of Public Policy.
  • The AMA has filed papers objecting to the union of the two companies. On Wednesday, Leon will hear from witnesses for CVS and the government. The hearing is set to wrap up Thursday.
  • Though the CVS-Aetna deal closed last year, Leon has yet to give his blessing to the settlement agreement and has said he has significant concerns about the merger’s effects on competition. This hearing will help him decide. It is the first time witness testimony will be taken in Tunney Act proceedings.

The government’s settlement agreement with CVS over its merger with Aetna required Aetna to sell off its Medicare Part D prescription drug plans (PDP) to rival WellCare. But Sood told the judge the divestiture won’t solve the anticompetitive concerns raised by the merger.
Leon is tasked with reviewing the settlement under the Tunney Act, which gives courts the power to review DOJ decisions. That law gives him significant discretion to determine if the settlement is in the public interest.
Leon has been skeptical of the CVS-Aetna deal struck with DOJ. He previously said the settlement addresses only “about one-tenth of 1%” of the nearly $70 billion mega-merger.
“In assessing whether or not the merger is in the public interest or not, which is my job, should I limit myself to the PDP market or should I look to the entities that are going to impact the greater market?,” the judge asked Sood, the first of six witnesses to testify at the hearing.
“That is a very loaded question,” Sood told the judge. But he told Leon the effects of the merger would go beyond the PDP market and affect the broader healthcare market. Among the likely effects he said would be increased premiums and increased government subsidies to enrollees’ Part D premiums.
The sell-off of the Aetna PDPs to WellCare won’t solve the anti-competitive effects of the deal as the government contends, Sood told the judge.
The merger means the loss of Aetna, “a very strong competitor” from the PDP market and the resulting loss of head-to-head competition between Aetna and CVS, Sood told the judge. And, Sood said, WellCare is not equipped to step into Aetna’s shoes.
“WellCare is a much weaker competitor than Aetna,” lacking Aetna’s brand recognition, economies of scale and larger subscriber base, Sood testified. Aetna’s total PDP subscribers totaled approximately 2.2 million, Sood said. WellCare has half that with approximately 1.1 million standalone Medicare Part D PDP members.
“No matter how strong WellCare gets, there will still be significant competitive concerns,” Sood said, noting WellCare gets its pharmacy benefit management (PBM) services from CVS itself.  This means CVS has the ability to increase costs or otherwise disadvantage WellCare. In addition, he said, WellCare is unlikely to be able to retain all of Aetna’s customers, he said.
Witnesses for the AIDS Healthcare Foundation and U.S. PIRG and Consumer Action were also scheduled to testify about the negative effects of the merger on Tuesday. Witnesses for the government and CVS are scheduled to testify Wednesday.
Meanwhile, WellCare may itself be the subject of an antitrust probe as it is planning to merge with Centene, the leader in Medicaid managed care plans in the country. The American Hospital Association wrote to the U.S. Department of Justice asking for a thorough review of the deal, which it said “threatens to reduce competition in delivery of Medicaid Managed Care and Medicare Advantage services to tens of millions of consumers across broad swaths of the country.”

Dario Health started at Buy at Craig-Hallum

Target $1.50

US FDA and EMA Accept Applications for Celgene MS Med

Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020. A regulatory decision from the EMA is expected in the first half of 2020.
Both applications are based primarily on ozanimod data from the SUNBEAM™ and RADIANCE™ Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials.
“The U.S. Food and Drug Administration and European Medicines Agency acceptances of our applications represent a crucial step forward in our efforts to bring ozanimod to people with multiple sclerosis,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene. “We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.”
Ozanimod is an investigational compound that is not approved for any use in any country.

Dermira upped to Buy from Neutral by Mizuho

Target $14 from $17

Cidera started at Outperform by Oppenheimer

Target $6

AstraZeneca blood cancer drug meets main goal in late-stage trial

AstraZeneca Plc said on Thursday its blood cancer drug met the main goal of a final stage trial, taking the treatment one step closer to a marketing approval as the drugmaker seeks to bolster its oncology portfolio.

In its second late-stage trial success in a month, the drug showed meaningful improvement in patients with chronic lymphocytic leukaemia when compared with a chemotherapy-based treatment, the company said.
The drug, Calquence, is a cornerstone product for AstraZeneca in haematology and its accelerated U.S. approval in 2017 marked its first entry into blood cancer treatment.
“The positive results from both the … trials will serve as the foundation for regulatory submissions later this year,” said R&D José Baselga, executive vice president of the company’s oncology division.
The drug, which is already approved by the U.S. drug regulator to treat a rare type of blood cancer, met the primary endpoint in a trial in May testing the drug in comparison with available treatment.
AstraZeneca acquired the drug, also known as acalabrutinib, when it bought a majority stake in Acerta Pharma in 2015.
Calquence is currently approved for treating adults with relapsed or refractory mantle cell lymphoma in the United States, Brazil, UAE and Qatar, and is being developed for the treatment of chronic lymphocytic leukaemia and other blood cancers.