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Sunday, March 10, 2019

Horizon Grabs Upgrade Despite DOJ Probe

Horizon Pharma (HZNP) grabbed an upgrade Friday despite a recent Department of Justice investigation into potential kickbacks. Horizon stock popped at the close.
The DOJ inquiry gouged more than 6% from Horizon stock on Wednesday. But shares rose 1.3% on Thursday and spiked 2.9%, to 26.56, on today’s stock market. Horizon stock is now about 17% extended from a buy point at 22.76 out of a cup-with-handle achieved last month.
Morgan Stanley analyst David Risinger says investors are undervaluing Horizon’s shift to therapies for rare diseases and rheumatology ailments. He upgraded Horizon stock to an overweight rating from equal weight, and kept his 32 price target.
The “transition to rare diseases is underappreciated,” he said in a note to clients. He estimates sales of rare disease and rheumatology treatments will account for 92% of total revenue in 2023, up from 72% in 2019. Those drugs will also account for 96% of profits in 2023, up from 70% in 2019, he said.

Horizon Stock Rises On Upgrade

The shift to rare disease and rheumatology treatments comes as Horizon faces price scrutiny for its primary care segment. But primary care is becoming less important for Horizon, Risinger said. He projects primary care sales declining to 8% of total revenue in 2023, down from 28% in 2019.
Drivers of the shift include gout treatment Krystexxa and the potential launch of teprotumumab to treat thyroid eye disease. If successful, teprotumumab will be the first approved treatment for thyroid eye disease, an ailment that causes the eyes to protrude from the socket.
Risinger expects Krystexxa to bring in $294 million in 2019 and grow to $579 million in 2023 sales. He also expects teprotumumab sales of $65 million in 2020, growing to $756 million in 2023. Primary care sales are expected to decline from $352 million in 2019 to $177 million in 2023.
The number of patients who could benefit from teprotumumab is low, Risinger said. But the price tag could be higher than expected. He notes his estimates for teprotumumab sales are more than double that of the consensus between 2021-23.
“Severe thyroid eye disease is a horrifying condition which causes eye and vision disablement, so we believe high orphan drug pricing is justified,” he said. “We project teprotumumab base case peak U.S. sales (in 2023) of $756 million based upon 4,200 patients treated at a net price of $180,000.”

NuCana shares ‘significantly undervalued,’ says Piper Jaffray

Piper Jaffray analyst Joseph Catanzaro is “incrementally more positive” around NuCana’s “ambitious” development strategy for the ProTide platform after speaking to management. The analyst continues to believe that clinical data presented to date have fully supported ProTide’s mechanism of action. Shares of NuCana are “significantly undervalued for the clear blockbuster potential” of NuCana’s two lead assets, Catanzaro tells investors in a research note. He maintains an Overweight rating on the shares and trimmed his price target to $35 from $36.
https://thefly.com/landingPageNews.php?id=2876869

Anthem (ANTM) PT Raised to $338 at Barclays

From $330.

FDA closes PolarityTE inspection with no action taken, says Piper Jaffray

The FDA has issued a final classification for the inspection that occurred at PolarityTE’s manufacturing facility last summer and it is now closed out with a Voluntary Action Indicated status, Piper Jaffray analyst Tyler Van Buren tells investors in a research note titled “Consider The Key Bear Thesis Removed: Manufacturing Resolution Reached W/ FDA.” The analyst believes investors can safely assume that no enforcement action will be taken or a warning letter issued. He finds this important as the single most common criticism he’s heard from investors is related to the Form 483 manufacturing observations. Van Buren also believes the lack of action cements SkinTE’s status as a 361 product, which he says was another common point of contention. This as a very positive development and removes one, and likely two, key bear theses on PolarityTE shares, Van Buren contends. As such, he expects the shares to be up on Monday, “especially considering the high short interest.” The analyst keeps an Overweight rating on PolarityTE with a $30 price target. PolarityTE closed Friday down 51c to $13.44.

23andMe Offers New Genetic Report on Type 2 Diabetes

23andMe, Inc., the leading personal genetics company, will begin offering a new genetic Health Predisposition report on type 2 diabetes.

The report offers customers insight into their likelihood of developing one of the most common, yet largely preventable, health conditions in the United States.
“Diabetes is a significant health issue in the United States that is expected to impact nearly half of the population. When customers learn about their genetic likelihood of developing type 2 diabetes, we believe there is an opportunity to motivate them to change their lifestyle and ultimately to help them prevent the disease,” said Anne Wojcicki, CEO and Co-Founder of 23andMe.
In the United States alone a staggering one in three American adults have prediabetes, and more than 90 percent don’t even know it, according to estimates from the U.S. Centers for Disease Control and Prevention. Worldwide, as lifestyle and diets are changing, the prevalence is also increasing. And beyond the very real human costs are the healthcare costs for treating the condition — in the United States, estimates for the costs of treating diabetes are more than $327 billion per year, according to the American Diabetes Association.
Despite those alarming statistics, there’s a reason to be optimistic. Diet and lifestyle changes can prevent or delay the development of type 2 diabetes. While genetics, family history, ethnicity, and age all contribute to the likelihood for developing type 2 diabetes, adopting a healthier diet and making lifestyle changes can reduce the possibility of developing the disease.
That’s where this report could help, by identifying people who may not know they have a genetic predisposition for diabetes and empowering them with information and tools to make lifestyle choices that can help prevent or delay the development of type 2 diabetes. The results can also aid in facilitating a conversation with your healthcare provider about appropriate screening and how to prevent the condition from occurring in the first place. Learning one’s predisposition for challenging health conditions, such as heart disease, has inspired lifestyle changes that can have positive impacts on long-term health.
23andMe’s new Type 2 Diabetes report is different from other 23andMe health reports because it was developed and entirely validated using 23andMe research data from more than 2.5 million 23andMe customers who have opted into research. Using this data, 23andMe scientists developed a polygenic score that drew on more than 1,000 genetic variants to calculate a customer’s likelihood of developing type 2 diabetes. Along with looking at those genetic factors, the report also informs customers how other factors such as their weight, age, and lifestyle may influence the likelihood of developing the condition and what actions might make a difference. It also provides educational resources on type 2 diabetes.
23andMe also knows that change isn’t always easy. That’s why 23andMe has recently collaborated with Lark Health, a consumer platform using A.I. coaching to manage and prevent chronic disease, to give 23andMe Health + Ancestry Service customers the opportunity to access applications that incorporate their genetic results for diabetes prevention and weight loss counseling.
The hope is that the report will help raise awareness about diabetes, as well as the potential to make healthy lifestyle changes to lower one’s likelihood of developing the condition. We’re excited by the possibility that this report has for making a difference in people’s lives.

Medicare advisers eye binding arbitration to control drug prices

A key panel of advisers is considering recommending that Congress adopt binding arbitration for Medicare Part B drugs that have extremely high launch prices.
Several members of the Medicare Payment Advisory Commission (MedPAC) on Thursday favored suggesting a system where a neutral agent would decide on a price for drugs purchased under Medicare Part B if they meet certain criteria.
“We have to do something to slow these launch prices, so I think binding arbitration is a way to get that done so I want to push forward,” said Warner Thomas, president and CEO of Ochsner Health System, a not-for-profit academic healthcare system in Louisiana.
Commission member Paul Ginsburg, director of the Center for Health Policy at Brookings Institution, also endorsed the practice but said it was also “potentially useful” for Parts D and A in Medicare.
He said that states have already pursued arbitration to combat surprise billing.
While MedPAC didn’t adopt a specific recommendation for Congress on drug pricing, the panel’s staff said the process could be similar to baseball’s approach, where teams and players have a neutral arbitrator decide a salary dispute.
The neutral arbitrator or arbitration panel for Medicare would be selected by a nonpartisan agency. If a drug has limited competition or an exorbitant launch price, HHS would start the arbitration process, staff suggested.
The drugmaker would need to abide by the arbitrator’s price decision for Medicare Part B providers and patients.
MedPAC only explored adopting binding arbitration for Part B, which covers physician-administered drugs, and not Part D.
The commission staff said drugmakers would participate in arbitration because theydo not want to lose out on Medicare’s market size.
But some MedPAC members weren’t ready to support the process and requested additional information.
Commission member David Grabowski, a professor of healthcare policy at Harvard Medical School, asked if the recommendation could include pre-negotiations between HHS and the manufacturer, a tactic that baseball teams and players use all the time.
The panel also discussed reference pricing, where a payer sets a maximum payment rate for a group of drugs with a similar health effect. The goal is to provide an incentive for a lower-cost alternative.
The Trump administration proposed an international pricing index model demonstration in October to set the price of Part B drugs to the price paid by countries overseas such as Germany or Japan.

Biotech week ahead, March 11

Last week was an event-filled one for the biotech space, with M&A, FDA decisions, clinical trial results and earnings all on offer.
Biogen Inc BIIB 2.33% announced an $800-million deal to buy Nightstar Therapeutics PLC NITE 0.32%.
Bio-Path Holdings Inc BPTH 45.96% was the biotech performer of the week, advancing more than 250 percent.
Depression drugs had contrasting effects on Johnson & Johnson JNJ 0.14% and Allergan plc AGN 1.51%, with the former’s novel treatment-resistant depression drug passing FDA muster — although with a boxed warning — while the latter’s major depressive disorder drug flunked a late-stage trial.

The following are key biotech catalysts that could sway stocks in the unfolding week.

Conferences

  • 13th Annual Conference on Stem Cell & Regenerative Medicine – March 11-12 in Nice, France
  • Cowen & Co. 39th Healthcare Conference – March 11-13 in Boston, Massachusetts
  • 13th Annual Canaccord Genuity Musculoskeletal Conference – March 12 in Las Vegas
  • Barclays Global Healthcare Conference 2019 – March 12-14 in Miami Beach
  • 20th World Dermatology Congress – March 13-14 in Singapore City, Singapore
  • 12th World Congress on Virology and Infectious Diseases – March 13-14 in Singapore City
  • BioCapital Europe 2019, organized by Life Sciences Partners – March 14 in Amsterdam, The Netherlands
  • Annual Congress on Neurology & Neuroscience – March 14-15 in Paris, France
  • European Autism Congress – March 14-15 in Zagreb, Croatia
  • 4th Global Summit on Heart Diseases – March 15-16 in Singapore City

PDUFA Dates

The FDA is set to rule on Regeneron Pharmaceuticals Inc REGN 1.69% and Sanofi SA SNY 0.09%‘s sBLA for Dupixent, with the approval being sought for an expanded indication to include adolescents with moderate-to-severe atopic dermatitis. The PDUFA date is scheduled for Monday.
Roche Holdings AG Basel ADR RHHBY 0.36% and Celgene Corporation CELG 1.46% await a FDA nod for Tecentriq plus chemotherapy Abraxane as first-line treatment of unresectable, locally advanced or metastatic triple-negative breast cancer in people whose disease expresses PD-L1 protein, as determined by PD-L1 biomarker testing. The PDUFA date is set for Tuesday.
The FDA will decide on Aerie Pharmaceuticals Inc AERI 0.75%‘s NDA for Roclatan — its investigational once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. The PDUFA date is scheduled for Thursday.

Earnings

Monday

  • Athenex Inc ATNX 1.67% (before the market open)
  • Dicerna Pharmaceuticals Inc DRNA 1.35% (after the market close)
  • Oxford Immunotec Global PLC OXFD 0.44% (after the market close)
  • Kala Pharmaceuticals Inc KALA 0.61% (after the market close)
  • Zafgen Inc ZFGN 2.93% (after the market close)

Tuesday

  • Corbus Pharmaceuticals Holdings Inc CRBP 0.51% (before the market open)
  • Aratana Therapeutics Inc PETX 1.32% (after the market close)
  • Clearside Biomedical Inc CLSD 2.99% (after the market close)
  • Verastem Inc VSTM (after the market close)
  • Inovio Pharmaceuticals Inc INO 5.92% (after the market close)

Wednesday

  • Trevena Inc TRVN 4.7% (before the market open)
  • Galmed Pharmaceuticals Ltd GLMD 1.3% (before the market open)
  • Infinity Pharmaceuticals Inc. INFI 3.23% (before the market open)
  • Miragen Therapeutics Inc MGEN 2.1% (after the market close)
  • Melinta Therapeutics Inc MLNT 1.29% (after the market close)

Thursday

  • Neos Therapeutics Inc NEOS 0.93% (before the market open)
  • Catabasis Pharmaceuticals Inc CATB 6.77% (before the market open)
  • Tetraphase Pharmaceuticals Inc TTPH 9.33% (after the market close)
  • Zosano Pharma Corp ZSAN 0.42% (after the market close)
  • BioDelivery Sciences International, Inc. BDSI (after the market close)

Friday

  • Diplomat Pharmacy Inc DPLO 1.72% (after the market close)

IPO Quiet Period Expiry