Search This Blog

Friday, November 30, 2018

Bausch Health To Redeem $200M Of 5.625% Senior Notes Due 2021


Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”) announced today that it will redeem $200 millionaggregate principal amount of its outstanding 5.625% Senior Notes due 2021, CUSIP Nos. 91911KAD4, C94143AD3 (the “Notes”) on Dec. 31, 2018. Bausch Health intends to use cash generated from operations to fund the aggregate redemption price for the Notes.
“Reducing our debt remains a priority for Bausch Health as we continue to transform the company, and due to strong recent operational cash flow, we are able to redeem these senior unsecured notes due in 2021,” said Joseph C. Papa, chairman and CEO, Bausch Health.
Bausch Health issued today an irrevocable notice of redemption for the Notes, and a copy was issued to the record holders of such Notes. Payment of the redemption price and surrender of the Notes for redemption will be made through the facilities of the Depository Trust Company in accordance with the applicable procedures of the Depository Trust Company. The name and address of the paying agent are as follows: The Bank of New York Mellon Trust Company, N.A., c/o The Bank of New York Mellon; 111 Sanders Creek Parkway, East Syracuse, N.Y. 13057; Attn: Redemption Unit; Tel: 800-254-2826.

Unsubsidized Health Insurance Consumers Turn to Short-Term Coverage


On Friday eHealth, Inc. (NASDAQ: EHTH) (eHealth.comreleased a report analyzing costs and trends among eHealth customers in the first half of the 2019 open enrollment period under the Affordable Care Act (ACA), which began November 1 and is scheduled to run through December 15, 2018.

eHealth’s report focuses on costs borne by individuals and families who do not qualify for or receive federal subsidies. It also examines trends among people selecting short-term health insurance plans at eHealth. eHealth’s analysis covers the period between November 1 and November 25, 2018 and compares findings to the same period a year before.
Key findings:
  • Increased interest in short-term plans: In the 2017 period under review, people selecting short-term plans at eHealth accounted for 56 percent of all combined short-term and ACA plan selections among people not receiving government subsidies for ACA plans; this figure increased to 70 percent for the same period in 2018.
  • Short-term premiums are stable while deductibles increase: The average monthly premium for individual short-term coverage is $107 this year, a decrease of four percent over the same period a year before; meanwhile, the average individual deductible increased 14 percent.
  • Average family premiums for ACA plans decrease 3 percent: The average monthly premium for family coverage among people not receiving government subsidies is $1,154, down from $1,191 in the same period a year ago.
  • Average individual deductibles for ACA plans decrease 7 percent: The average annual deductible for individual coverage among people not receiving government subsidies is $4,064, down from $4,358 in the same period a year ago.
eHealth’s report also examines average customer selections by plan type (HMO, PPO, etc.) and metal level. eHealth intends to follow up this report with additional updates on market costs and trends in the ACA market at the close of open enrollment.

Upcoming Highlights from 60th Annual American Society of Hematology Meeting


The American Society of Hematology is holding its 60th Annual Meeting & Exposition starting December 1 and running through December 4 in San Diego. Most of the players, big and small, in cancer drug therapies will be there, presenting updates and breaking stories about their hematology pipelines.
The meeting starts bright and early on Saturday morning at 7:30 a.m. with an Ad Hoc Scientific Committee on Epigenetics and Genomics. This will also be repeated on Sunday at 9:30 a.m. Nicholas Haining, of the Broad Institute of MIT and Harvard, will discuss the role of epigenetics in T-cell exhaustion. Robert Schreiber, Alumni Endowed Professor of Pathology and Immunology at Washington University School of Medicine will look at the use of complementary forms of high-dimensional genomic profiling. Andrei Thomas-Tikhonenko of Children’s Hospital of Philadelphia will discuss novel mechanisms of resistance to CD19-directed immunotherapies.

The panel will be chaired by Julie-Aurore Losman of the Dana-Farber Cancer Institute.
At the biopharma industry level, AbbVie presented a late-breaking abstract ahead of the meeting regarding its Imbruvica as a first-line of treatment in chronic lymphocytic leukemia. Geoffrey Porges, analyst with Leerink, called it “remarkable efficacy.”
Johnson & Johnson and Genmab will present data about Darzalex in multiple myeloma.
Bloomberg notes, “Investors will also be watching for real-world results in patients getting CAR-T treatments as well as the next generation of immunotherapies, particularly those targeting a protein linked to multiple myeloma known as B-cell maturation antigen (BCMA).”
Celgene and bluebird bio’s BB2121 appears to be ahead of the game for previously treated relapsed BCMA myeloma. But J&J has LCAR-B38M, an asset it licensed from Hong Kong’s Genscript Biotech that could be competitive, as is Amgen’s AMG-420.
In addition, Unum Therapeutics and Seattle Genetics are evaluating ACTR087 in BCMA-related cancers.
Allogene will update its pipeline, including its UCART19 program with Servier on Monday, December 3. Global Blood Therapeutics is making an oral presentation for Part A of its Phase III HOPE trial and data from the 1,500-milligram cohort of the HOPES-KIDS 1 trial with voxelotor on Monday as well.
Also on Monday, Incyte will present detailed data from its REACH1 clinical trial for Jakafi in graft-versus-host disease.
And, today, starting at noon, is ASH-a-Palooza for the “Trainee Day” attendees. What the event calls “a new educational experience that will offer a relaxed, open learning environment for trainees in a festival-like setting with multiple opportunities for micro learnings,” will be held before the start of the official meeting at Petco Park, home of the San Diego Padres. The stadium is across the street from the convention center.
ASH-a-Palooza includes a number of programs it dubs “Blood Drops,” including “Early career planning topics,” “Hematology 101: an entry level clinical topic,” and others.
Various workshops for ASH-a-Palooza includes “Identifying Known and Novel Germline Variants” and “K2R Introduction.”
Its career-oriented programs include mentoring sessions called something only a hematologist would love: “Blood Buddies.”
Friday also marks a number of pre-meeting scientific workshops, including a workshop at 1:00 p.m. to 5:45 p.m., “Hematology and Aging: Scientific Advances From Sickle Cell Disease to Malignant Hematology,” “Tumor Immune Interactions in Lymphoid Malignancies,” scheduled for 1:00 p.m. to 5:30 p.m. and several others.
Numerous other academic researchers and biopharmaceutical companies will attend, presenting business and career opportunities, as well as scientific presentations, abstracts and posters. Spectrum Pharmaceuticals, for example, is presenting three posters, including, “Management of Mucositis with Use of Leucovorin as Adjunct to Pralatrexate in Treatment of Patients with Hematological Malignancies including of Peripheral and Cutaneous T-Cell Lymphomas-Results from a Prospective Multicenter Phase II Clinical Trial.”
GlycoMimetics is hosting and webcasting an investor/analyst meeting and update December 3 at 6 a.m., where it will, among other things, present data from its recently completed Phase I/II clinical trial of uproleselan in acute myeloid leukemia patients.
And those are just a few examples of the activities and presentations that will take place at one of the biggest and most important cancer-related meetings held annually.

Investor Litt urges split of Brookdale into REIT and senior housing operator

Bloomberg reports that activist Jonathan Litt is proposing that Brookdale Senior Living (BKD +1.9%) be split into a real estate investment trust (REIT) and an operator of senior housing.
In a conference call two days ago with Chairman Lee Wielansky and CEO Cindy Baier, he said that moving the company’s best properties into a REIT would unlock significant value.
BKD operates almost 1,000 facilities in 46 states. Shares are currently exchanging hands at $8.50, a modest 1.8 price/book ratio. Competitor Capital Senior Living (CSU -2.8%), for example, currently trades at 4.5x book.

Buy Amarin (AMRN) Ahead of Positive Catalysts – Cantor


Cantor Fitzgerald analyst Louise Chen reiterated an Overweight rating and $35 price target on Amarin Corporation

What’s Going On With Adial Pharmaceuticals


Shares of micro-cap Adial Pharmaceuticals Inc ADIL 37.14% have skyrocketed 196 percent in the past week on news that the company has established a Scientific Advisory Board (SAB) to explore advancement of the company’s leading drug candidate AD04 for the treatment of alcohol use disorder.
Traders are now learning more about Adial and its business to determine whether or not this week’s rally is a buying or selling opportunity.

What Does Adial Do?

Adial is a biopharmaceutical company focused on developing drugs for treatment of addictive behavior, particularly as it relates to alcohol abuse. AD04 is the company’s leading candidate and is in Phase IIb clinical trials to treat AUD, which impacts an estimated 35 million people.
Adial is part of a new wave of addiction treatment drug companies in the wake of a nationwide opioid addiction crisis, which includes companies like Alkermes Plc ALKS 1.93% and BioDelivery Sciences International, IncBDSI 3.69%.

Why The Big Move?

After a disappointing 2018 for Adial investors, traders seem to see news of an SAB forming as a positive sign that AD04 is making progress. With the stock down about 70 percent on the year prior to this week, some buyers may see a compelling reason to get into the name at a discount, while others are likely simply trading the short-term momentum in the name.
Adial has a negligible short percent of float of only 0.5 percent, but its 3.5 million-share float makes the stock vulnerable to large swings when buying triggers heavy volume. Adial has averaged a daily trading volume of only 141,000 shares over the past three months, but the stock had already traded more than 17.1 million shares as of about 1:30 p.m. ET Friday.
At this point, Adial investors are certainly used to volatility. In fact, the stock has gained at least 12 percent in a single day eight times in 2018 alone and dropped at least 12 percent in a day seven times.

What’s Next?

Long-term investors will be watching for updates from the SAB on the plan for AD04 moving forward. Short-term traders will be watching for a potential near-term top in the stock as a potential shorting opportunity with the stock’s RSI now well into overbought territory at 76.9.

Biotech Investors: Mark Your Calendar For These December PDUFA Dates


The year is drawing to the close, and biotech stocks have had a fairly good run despite the market-wide downturn in October and Novmeber.
New molecular moiety (NME) approvals thus far this year totaled 52, already beating the previous year’s number of 46. NMEs are active moieties that haven’t been approved by FDA previously, either as a single ingredient drug or as part of a combination product, and are an indicator of innovation in drug research.
Here’re are the key PDUFA catalysts for the unfolding month.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Roche’s Lung Cancer, Influenza Drugs Under FDA Scanner

  • Company: Roche Holdings AG Basel ADR RHHBY 1.82%
  • Type of Application: sBLA
  • Candidate: Tecentriq in combination with Avastin, and chemotherapy regimen carboplatin and paclitaxel
  • Indication: Initial treatment of people with metastatic non-squamous non-small cell lung cancer, or NSCLC
  • Date: Dec. 5
The sBLA for the treatment combo was accepted for review with Priority Review status in May, with the application submitted based on results from the Phase 3 Impower 150 study. The company announced in September FDA’s decision to extend the review period by three months, which has rendered the new PDUFA date at Dec. 5.
Roche also has another PDUFA catalyst during the month.
  • Type of Application: NDA
  • Candidate: Baloxavir marboxil
  • Indication: Influenza
  • Date: Dec. 24
Baloxavir marboxil is a single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the flu virus, including oseltamivir-resistant strains and avian strains.

ADMA Awaits FDA Nod For Amendment To BLA For Immunodeficiency Drug

  • Company: ADMA Biologics Inc ADMA 2.59%
  • Type of Application: Prior Approval Supplement, or PAS, filing
  • Candidate: Bivigam
  • Indication: Intravenous immuno globulin indicated for the treatment of primary humoral immunodeficiency
  • Date: Dec. 18
The FDA granted approval for Bivigam to Biotest Pharma in December 2012, but production was halted by the company in December 2016. Subsequently in June 2017, ADMA obtained ownership and all rights, title and interest in Bivigam through its Biotest Therapy Business unit asset acquisition.
ADMA then optimized the production process and submitted the PAS to amend the BLA for Bivigam in June, and the PDUFA date was initially set at Oct. 25. This was extended by two months, as the FDA deemed the company’s response to its information request as a major amendment.

Jazz Losing Sleep Over Sleep Disorder Drug

  • Company: Jazz Pharmaceuticals PLC JAZZ 2.49%
  • Type of Application: JZP-110 ( Solriamfetol)
  • Candidate: NDA
  • Indication: Treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
  • Date: Dec. 20
The FDA had accepted the application March 2.

Can Second Time Be Charm For Ocular?

  • Company: Ocular Therapeutix Inc OCUL 9.9%
  • Type of Application: Dextenza (dexamethasone) 0.4mg
  • Candidate: NDA
  • Indication: Treatment of ocular pain following ophthalmic surgery
  • Date: Dec. 28
Following the original submission, the FDA handed down a CRL in July 2016 on the pretext of manufacturing deficiencies. The resubmission, which was deemed complete, was made in July 2017.

Merck’s Wonder Cancer Drug Gears For Another Approval

  • Company: Merck & Co., Inc. MRK 1.71%
  • Type of Application: sBLA
  • Candidate: Keytruda
  • Indication: Merkel cell carcinoma, a rare form of skin cancer
  • Date: Dec. 28
The sBLA was submitted based on data from the Phase 2 KEYNOTE-017 trial.

Bristol-Myers Squibb Seeks Approval For Expanded Use Of Pediatric Leukemia Drug

  • Company: Bristol-Myers Squibb Co BMY 3.17%
  • Type of Application: sBLA
  • Candidate: Sprycel in combination with chemotherapy
  • Indication: Treating pediatric patients with newly diagnosed Ph+ acute lymphoblastic leukemia, or ALL.
  • Date: Dec. 29
Sprycel was earlier approved for the treatment of children with Ph+ chronic myeloid leukemia, or CML. It was first approved in 2016 for the treatment of adults with Ph+ CML in chronic phase, who are resistant or intolerant to prior therapy including imatinib.

FDA To Rule On Portola’s PAS For Anticoagulation Antidote Drug

  • Company: Portola Pharmaceuticals Inc PTLA 4.5%
  • Type of Application: PAS
  • Candidate: Andexxa
  • Indication: Antidote for anticoagulation
  • Date: Dec. 31
Andexxa was approved May 3. The company’s PAS is meant for large-scale Generation 2 manufacturing process for Andexxa.
“If accepted and approved, the PAS will allow for the broad commercial launch of Andexxa in the United States,” the company said in a Sept. 11 release.