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Monday, June 24, 2019

HCA Holdings (HCA) PT Raised to $181 at UBS; ‘See Inflection Coming Again’

UBS analyst Whit Mayo raised the price target on HCA Holdings (NYSE: HCA) to $181.00 (from $172.00) while maintaining a Buy rating.
The analyst commented, “We sense a two-fold inflection on the way. First, we think HCA is poised to surprise on the upside with an acceleration of its capital spending plans reinforced by heightened conviction around its cash flow position, out-year growth opptys and continuously refined processes around capital allocation. Second, few investors appreciate the Medicare pricing tailwind which we peg adding 50% to HCA’s annual 4-6% EBITDA growth in 2020 alone ($230m+). Moreover, we see HCA meaningfully taking advantage of its historically low leverage to turn more aggressive on buybacks at unprecedented levels. We see at least a $1/sh (+8%) of EPS upside in 2020.”

Immunic has previously unpublished data on IBD treatment candidate

Immunic, Inc. (IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, announced that Hella Kohlhof, Ph.D., Chief Scientific Officer of Immunic, will present today previously unpublished data regarding the company’s lead program, IMU-838, at the GI Inflammatory Diseases Summit (GIIDS) in Boston. The presentation, entitled, “IMU-838 in Clinical Phase 2 – New Selective Oral Treatment for IBD,” will take place at 3:30 pm ET. IMU-838, currently in phase 2 clinical development for the treatment of ulcerative colitis (UC) and relapsing-remitting multiple sclerosis (RRMS), is an orally available, next-generation selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme dihydroorotate dehydrogenase (DHODH).
Highlights of Dr. Kohlhof’s presentation will include these newly released findings:
  • Preclinical data shows that IMU-838 appears selective towards those T cells producing high amounts of the pro-inflammatory cytokines, IFNγ and IL-17.
  • In mixed lymphocyte reaction assays in combination with the anti-TNFa antibody infliximab, IMU-838 was shown to act synergistically with regard to the induction of regulatory macrophages, important for the efficacy of such anti-TNFa antibodies.
  • In addition to previous inflammatory bowel disease animal models, IMU-838 also demonstrated activity in a therapeutic animal colitis model with improvement of diarrhea score and significant TNFa reduction in the gut.
Dr. Kohlhof’s presentation will also highlight the following advantages of IMU-838:
  • As a DHODH intrinsic effect, IMU-838 is, in-vitro, able to inhibit reactivation of several viruses. Other immunosuppressive drugs used for the treatment of inflammatory bowel disease and multiple sclerosis are known to have virus reactivation as one of the clinically significant adverse drug effects.
  • In comparison to other DHODH inhibitors, IMU-838 does not target any kinases and does not exhibit an increased rate of side effects, such as diarrhea, alopecia, or neutropenia. Notably, these attributes do not seem to be a class effect of DHODH inhibitors. No signal for an increased rate of liver enzyme elevation has been seen, to date, in the clinical trials. With a terminal half-life of 30 hours in blood plasma, IMU-838 is well suited for convenient, once daily oral dosing, reaching steady state exposure after 5-7 days of treatment and washing out within 10-14 days in most patients.
  • In a phase 2a clinical study in steroid dependent UC and Crohn’s disease patients, the active moiety of IMU-838 (vidofludimus) has shown activity in the ability to wean off steroids, with a total response rate of 88.5%.

Bayer starts Phase 3 trial of Aflibercept to prevent blindness in premature infants

Bayer has initiated a Phase III trial of its anti-VEGF treatment aflibercept for intravitreal injection in retinopathy of prematurity (ROP), an eye condition in premature infants which can lead to irreversible blindness.
ROP occurs in premature infants as a result of incomplete or abnormal development of blood vessels serving the retina, potentially causing scarring and retinal detachment leading to visual impairment and irreversible blindness. Even with the currently available treatments it is believed to account for 6-18% of childhood blindness in developed countries. Taking into account its prevalence and severity, childhood blindness, including ROP, is a priority for VISION 2020: The Right to Sight, a joint global initiative between the World Health Organization and the International Agency for the Prevention of Blindness.
‘To suffer severe irreversible vision loss beginning in infancy is devastating for both affected children and their families, and preventing it must always be an absolute priority,’ said Professor Stahl from the University Eye Hospital in Greifswald, Germany. ‘In its severest form, retinopathy of prematurity can cause total blindness; however, it is also a condition that, for many, can be managed if detected and treated appropriately at the right time. Since many mechanisms of the disease are not yet sufficiently known and the condition remains an ongoing threat around the globe, it is important to continue to further research into retinopathy of prematurity.’
‘Childhood visual impairment and blindness can have far-reaching consequences, affecting all aspects of a child’s development. We have initiated this Phase III study to evaluate the potential of providing physicians with an additional treatment for premature infants with ROP,’ said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. ‘This trial is an important step forward in our commitment to addressing the most significant unmet needs in ophthalmology.’
This Phase III, multi-center, randomized trial is designed to assess efficacy, safety and tolerability of intravitreal aflibercept for the treatment of ROP. Approximately 100 infants will be enrolled in 34 countries and will be randomized to receive intravitreal aflibercept or laser photocoagulation.
Aflibercept is a proven treatment option for patients with visual impairment due to several retinal conditions and has consistently delivered excellent outcomes in reducing preventable vision loss, both in randomised clinical studies as well as in real world clinical settings.
Aflibercept has been approved under the brand name EYLEA in approximately 100 countries for five indications to treat patients with wAMD and patients with visual impairment due to: macula edema following retinal vein occlusion (RVO; branch RVO or central RVO) and diabetic macular edema (DME). Aflibercept has also been approved for the treatment of myopic choroidal neovascularization. Around 25 million vials of Eylea have been sold since launch worldwide resulting in approximately 3.6 million patient years of experience.
Bayer and Regeneron Pharmaceuticals, Inc. are collaborating on the global development of aflibercept. Regeneron maintains exclusive rights to Eylea in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea, except for Japanwhere Regeneron receives a percentage of net sales.

Antitrust Concerns Delay Bristol-Myers’ $74 Billion Merger With Celgene

Bristol-Myers Squibb Co. said its $74 billion merger with Celgene Corp. would be delayed as the company works to allay concerns of federal regulators by selling off Otezla, Celgene’s anti-inflammatory drug that had global sales of $1.6 billion last year.
Bristol-Myers now expects to complete the deal at the end of this year or early 2020, the company said Monday. It had previously expected the merger to close in the third quarter of this year.
The company hopes the planned divestiture of Otezla will resolve the U.S. Federal Trade Commission’s anticompetitive concerns about clearing the merger.
The divestiture came as a surprise to analysts, who said it was the latest signal that regulators are taking a tougher stance in their scrutiny of pharmaceutical industry mergers.
The delay appeared to create uncertainty among investors about the merger being completed, analysts said. Celgene’s stock fell 5.1% to $93.86 in midday trading Monday; shares of Bristol-Myers declined 7.2% to $45.80.
Brian Skorney, an R.W. Baird analyst, said Bristol-Myers’s plan to divest itself of Otezla signaled the company had found a way to resolve the FTC’s concerns and increased the probability of the deal closing.
“It’s feedback on what the FTC wants, and it seems like this is the major thing to come from the FTC discussions,” Mr. Skorney said in an interview.
Otezla is used to treat forms of psoriasis, a skin-disease in which an overreaction by the immune system causes itchy rashes to form on the body. Bristol doesn’t currently sell psoriasis medicines, but has an experimental drug for the disease in late-stage trials.
Historically, antitrust regulators would only raise concerns about drugs in overlapping disease areas if both products were already on the market, Mr. Skorney said. That now appears to be changing.
Earlier this month, Roche Holding AG said the FTC had requested additional information regarding its planned takeover of Spark Therapeutics Inc. Analysts speculated that the FTC’s concerns were related to overlap between Roche’s hemophilia treatment Hemlibra and an experimental gene therapy for the disease being developed by Spark.
“Both of these deals have gotten more scrutiny than people expected,” said Mr. Skorney. “How does that impact how pharma acquirers look at deals going forward?”
Otezla was Celgene’s third largest drug by sales last year and represented about 10.6% of the company’s total revenue.
It is uncertain how long the drug will retain market exclusivity; R.W. Baird estimates that it could lose patent protection after 2023. Otezla could fetch $6 billion to $10 billion in a sale, Mr. Skorney said.
Separately, New York-based Bristol Myers said Monday that its late-stage study of cancer immunotherapy Opdivo didn’t meet the main goals in a study probing its use in a common liver cancer but showed an improvement in the overall survival of patients treated with the drug compared with Bayer AG’s Nexavar, which is the current standard of treatment.

New data on Affimed’s lead candidate fails to excite investors

Affimed (AFMD -12%) slumps on average volume in response to updated results on lead candidate AFM13 in patients with CD30-positive lymphomas. The data were presented at the International Conference on Malignant Lymphoma in Lugano, Switzerland.
Final results from a Phase 1b study assessing the combination of AFM13 and Merck’s (MRK +1.2%) Keytruda (pembrolizumab) in relapsed/refractory Hodgkin lymphoma showed an 88% objective response rate (ORR) (the ORR for Keytruda alone in Hodgkin lymphoma was 69% in the KEYNOTE-087 study), including a 42% complete response (CR) rate (determined by investigators). The CR rate was about double that for Keytruda alone (22% in KEYNOTE-087). ORR and CR were 85% (n=11/13) and 46%, respectively, in a subgroup of patients who failed to respond to Seattle Genetics’ (SGEN-0.9%) Adcetris (brentuximab vedotin).
Estimated progression-free survival (PFS) at months 6 and 12 were 78% and 45%, respectively.
Updated data from a Phase 1b/2a study of AFM13 in patients with relapsed/refractory CD30-positive lymphoma with skin lesions showed an ORR of 50% (n=5/10). Two of the responders had a treatment-resistant type of lymphoma called transformed mycosis fungoides.

Centene and WellCare stockholders back tie-up

As expected, Centene (CNC -2%) and WellCare Health Plans (WCG -1.3%) shareholders have voted in favor of the planned $17.3B merger. The transaction should close by H1 2020.

Centene, Humana at head of line for cash windfall on positive ObamaCare ruling

In a note, Evercore ISI’s Michael Newshel writes that Centene (CNC -2.1%) and Humana (HUM -1.6%) stand to reap the greatest benefits from a positive Supreme Court ruling in a case involving costs to health insurers related to the Affordable Care Act during the years 2014 – 16. The Court has agreed to review the matter next year.
If the Court rules in favor of managed care providers, CNC and HUM could potentially receive ~$600M and ~$400M, respectively.
Mr. Newshel says the potential windfall will have no impact on run-rate earnings since the companies wrote off the risk corridor payments some time ago.
Related tickers: UnitedHealth Group (UNH -1.1%), Cigna (CI -1%), Anthem (ANTM -2.2%), Molina Healthcare (MOH -2.5%)