Monday, January 14, 2019
Medifast repeats FY18 EPS view of $4.45-$4.50, consensus $4.52
Repeats FY18 revenue view of $-$497.5M, consensus $498.03M. Guidance repeated in slides for the company’s January 2019 investor presentation.
https://thefly.com/landingPageNews.php?id=2848403
Canopy Growth Granted New York State Hemp Licence
Canopy Growth Corporation (TSX: WEED) (NYSE: CGC) has been granted a licence by New York State to process and produce hemp. Thanks to the work of key state and federal government officials from the State of New York, Canopy Growth is proud to outline its commitment to invest in New York in order to establish a Hemp Industrial Park. Governor Andrew M. Cuomo’s leadership at the state level led to the creation of the Hemp Research Pilot Program, a standout in the nation. U.S. Senator Charles E. Schumer was instrumental in the passage of the Farm Bill, a transformative piece of legislation that gave Canopy Growth the federal guidance it needed to make a significant investment in New York.
Canopy Growth will establish within the Hemp Industrial Park large-scale production capabilities focused on hemp extraction and product manufacturing within the United States.
“Canopy Growth was founded to drive innovation within the cannabis and hemp industries. In New York we see an opportunity to create products that improve people’s lives,” said Bruce Linton, Chairman and Co-CEO, Canopy Growth. “In the process, we will create jobs in an exciting, highly profitable new industry. I applaud the political leadership at the federal and state level that has allowed today’s announcement to become reality.”
Depending on Board approval of a specific site, Canopy Growth intends to invest between $100 million USD and $150 million USD in its New York operations, capable of producing tons of hemp extract on an annual basis. The project is another example of the strategic advantage Canopy Growth has earned with the recently-closed $4 billion USD strategic investment made by Constellation Brands, a New York-based beverage alcohol leader and Fortune 500 company.
“Canopy Growth’s $100-$150 million investment in the Southern Tier is a true win-win – for Canopy Growth, who will be positioned at the forefront of Upstate New York’s industrial hemp revolution, and for the Southern Tier’s economy and farmers, which will receive a major shot in the arm in new good-paying jobs. I fought so hard to strip the burdensome federal regulations from industrial hemp in our Industrial Hemp Farming Act of 2018, which was recently included in the Farm Bill, because I knew how much it could mean to the Southern Tier, and this investment proves it. I’m so pleased that Canopy Growth is joining my efforts to make the Southern Tier the Silicon Valley of industrial hemp production and research and will keep pushing to see industrial hemp become a true cash crop in the region,” said Senator Schumer.
Based on its expertise in hemp-derived cannabinoid extraction and processing, Canopy Growth has been granted a licence by New York State to process hemp for various applications. Canopy Growth is a large-scale extractor with specific experience producing standardized medical products. Its production processes have achieved GMP certification, the global standard for pharmaceutical production, at its Canadian headquarters in Smiths Falls, Ontario.
The Company is in the process of evaluating a number of sites in the Southern Tier of New York, which will become one of its first extraction and processing facilities outside Canada. The Company intends to announce the specific location within 100 days. Canopy Growth will be the anchor business in the broader Hemp Industrial Park where third parties can join an innovative hemp ecosystem focused on every potential application of the hemp crop, from fiber, to seed, to cannabinoids. Canopy Growth’s operations alone will contribute to significant employment in the region, with the objective of anchoring a broader hemp ecosystem, maximizing long term economic benefits for the region and its communities.
Canopy Growth will source hemp exclusively from American farmers for its American operations once up and running. The Company believes that the Farm Bill has the power to create a thriving new industry with American farmers as the backbone. Canopy Growth can add value by focusing on its areas of expertise, including extracting, processing and formulating cannabinoid-based consumer products and medicines.
With the recent passage of the Farm Bill and support of the State of New York, management is confident in a path to market hemp-based cannabinoid products in America.
Last week Canopy Growth publicly outlined its hemp advantage. The Company has an unmatched combination of hemp-specific IP, cash reserves, and technical expertise required to succeed in this industry.
Rexahn to Present Data at ASCO Gastrointestinal Cancers Symposium
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, today announced that it will present updated preliminary safety and efficacy data from the ongoing Phase 2a clinical trial of RX-3117 in combination with ABRAXANE® in first-line metastatic pancreatic cancer patients at the 2019 American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Cancers Symposium being held January 17-19, 2019 at the Moscone West Building in San Francisco, CA.
The poster will be presented on Friday, January 18, 2019 at 11:30 AM-1:00 PM and 5:30 PM-6:30 PM PST. A copy of the poster being presented will be available on the Company’s website at https://www.rexahn.com/news-media/posters beginning at 10:00 AM EST on Friday, January 18, 2019.
Details of the poster presentation are as follows:
Title: A phase 1/2 study of RX-3117, an oral antimetabolite nucleoside, in combination with nab-paclitaxel (nab-pac) as first line treatment of metastatic pancreatic cancer (met-PC): Preliminary results.
Abstract Number: 420
Poster Board: M20
Session Information: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Abstract Number: 420
Poster Board: M20
Session Information: Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Massachusetts Initiative Eyes Payment Plans for Novartis’ SMA Gene Therapy
Many of the new biologic drugs and gene therapies coming on the market have shockingly high prices. Examples include Novartis’ cancer cell therapy, Kymriah, running about $475,000, Gilead’s competitive treatment, Yescarta, priced at $373,000, and Spark Therapeutics’ Luxturna for a hereditary eye disease running about $425,000 per eye.
Payers, recognizing the value of these treatments, often for diseases for which there are no other treatments, or which have the potential to cure the disease instead of involving life-long treatment, are experimenting with new payment approaches.
On December 3, 2018, the U.S. Food and Drug Administration (FDA) accepted Novartiscompany AveXis’ Biologics License Application (BLA) for AVXS-101, Zolgensma, a gene replacement therapy for spinal muscular atrophy (SMA) Type 1. The FDA has a target action date of May 2019 for the gene therapy.
SMA is caused by a defective or missing SMN1 gene. Infants with SMA Type 1 quickly lose the motor neurons for muscle functions like breathing, swallowing, speaking and walking. If untreated, most die by the age of two years. The FDA approved Biogen’s Spinraza (nusinersen) for SMA in January 2018. Spinraza was the first treatment for the drug available.
Spinraza came with a price tag of $750,000 for the first year and $375,000 for each year afterward. Patients receive six injections in the first year at about $125,000 per shot.
Although a price has not been locked in yet for AveXis’ Zolgensma, numbers as high as $5 million have been broached, although the range is from about $1.6 million to $5 million. The State of Massachusetts is considering a payment plan as a viable model to pay for the treatment.
“Think of it as an installment plan that’s then tied to how well the therapy works,” Mark Trusheim, strategic director of the MIT Center for Biomedical Innovation’s NEWDIGS program, told Business Insider. “This would be a car loan but you’ve still got to see if the car is going to work.”
NEWDIGS is attempting to bring together various organizations to discuss how the U.S. healthcare system will pay for the expensive new therapies. The Massachusetts Initiative came out of that organization.
According to Trusheim, only about 12 to 24 patients are expected to receive the treatment each year in Massachusetts.
Under the possible proposal for Zolgensma in Massachusetts, payers would pay for the therapy in five annual installments, paid out over four years.
bluebird bio made a similar proposal at last week’s JP Morgan Healthcare Conference for its upcoming LentiGlobin gene therapy for transfusion-dependent ß-thalassemia (TDT). This is an inherited blood disorder caused by a mutation in the ß-globin gene. LentiGlobin has not been approved yet, or priced, but figures as high as $2.1 million have been floated.
The company proposed a payment-plan scheme that would run for five years, with each annual payment from health plans to bluebird bio being contingent on the gene therapy’s continued effectiveness.
The Massachusetts Initiative plans to start with AveXis’ Zolgensma but expects to add other gene therapies. They hope to launch the program by this summer. One aspect that is being addressed is what happens if patients switch health insurance programs. The insurers that plan to participate in the program have agreed to cover the remaining payments on the payment program.
They haven’t determined yet what to do if a patient moves to a different state.
For its part, AveXis has stated, “Our objective is to ensure patients get access to this therapy, so we can make a meaningful difference in their lives. We are working closely with payers to ensure we establish appropriate prices reflecting the value of gene therapy and explore creative options for payers, including installment payment options, as well as outcomes-based arrangements.”
Tilray gains pre-IPO lock-up expiration as largest shareholder not planning to sell
Tilray (TLRY) is on the rise again after surging almost 20% on Friday following a statement by Privateer Holdings saying it does not have plans to register, sell or distribute the 75M shares that it owns when an initial public offering lock-up expires on Tuesday, January 15. Meanwhile, Piper Jaffray analyst Michael Lavery started coverage of the stock with an Overweight rating last week, saying Tilray “has the ingredients for long-term growth.”
PRIVATEER HOLDINGS NOT PLANING TO SELL: In a statement late last week, Privateer Holdings said it does not have plans to register, sell or distribute the 75M shares that it owns in Tilray when the lock-up expires. “Privateer Holdings strongly believes in Tilray’s long-term global growth strategy and pioneering role in shaping the future of the legal cannabis industry. Given this, we do not have plans to register, sell or distribute the shares Privateer holds in Tilray during the first half of 2019. When we decide to distribute shares, we will do so in an orderly and deliberate manner to maximize tax-efficiency considerations for Privateer investors, while also taking into consideration potential impacts on Tilray’s public float. And we will do it in a way that reflects our long-term confidence in Tilray’s business model and management team,” Michael Blue, Managing Partner of Privateer Holdings, said. Over the last months, Tilray stock has came under pressure with the pending IPO lock-up January 15 date. Such lockup periods are designed to prevent company insiders – including employees, their friends and family and venture capitalists – from selling their shares for a set period of time, according to the Securities and Exchange Commission. Commenting on the announcement and the upcoming IPO lock-up expiration, Roth Capital analyst Scott Fortune noted there are currently about 93M Tilray shares that are technically tradeable upon the expiration of the lock-up, but Privateer currently owns 75M and management has stated there are highly adverse tax consequences for the shareholders if they are converted and sold prior to the end of April, 2019. As a result, the analyst believes only about 8%, or 8M, of shares outstanding will be released from the lock-up. Regarding Privateer’s 75M shares, Fortune said he expects a gradual distribution to occur starting in mid-2019, in a limited manner and a highly managed process over time to limit the market impact on Tilray’s share price. The analyst has a Neutral rating on Tilray’s stock.
PIPER SAYS BUY TILRAY: Last week, Piper Jaffray’s Lavery initiated coverage of Tilray with an Overweight rating and $90 price target. The analyst told investors that he expects “strong” industry growth long-term, and believes Tilray is well positioned to be one of several likely winners given its relationships in medical, in the U.S., and in beverages. While Lavery acknowledged that the company’s IPO lock-up expiry is a near-term risk, especially with 77% insider ownership, he pointed out that his 12-month Overweight view is based on its fundamental outlook. He pegs Tilray’s market opportunity at $15B-$50B in the near-term, and potentially $250B-$500B over the longer term.
CVS Health headwind concerns overblown, says Cowen
Cowen analyst Charles Ryhee updated his model on CVS (CVS) to reflect headwinds from rebate guarantees and Aetna’s (AET) large group rated business. He believes the pressure on the shares due to rebate guarantees is overdone in that it represents less than 2% of its revenues. Ryhee reiterated his Outperform rating and $103 price target on CVS shares.
https://thefly.com/landingPageNews.php?id=2848313
Verona Pharma’s nebulized ensifentrine shows mixed results
Verona Pharma (NASDAQ:VRNA) announces the results from a three-day Phase 2 pharmacology study evaluating two doses (1.5 mg and 6.0 mg, twice daily) of nebulized ensifentrine on top of an inhaled long-acting muscarinic antagonist/long-acting beta2 agonist (LAMA/LABA), tiotropium/olodaterol (Boehringer Ingelheim’s Stiolto Respimat) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Those receiving a stable dose of inhaled corticosteroid (ICS) therapy were allowed to continue throughout the study.
The study failed to achieve the primary endpoint of forced expiratory volume in one second (FEV1), a measure of lung function, after morning dose on day 3 compared to placebo. Peak FEV1 after evening dose on day 3, however, did show statistically significant separation from control for both doses.
Average FEV1 improved over 12 hours following the morning dose of 1.5 mg on days 1-3 but the effect was not statistically significant.
The 6.0 mg dose did not produce a greater improvement in lung function versus the 1.5 mg dose.
A Phase 2 clinical trial assessing a dry powder inhaler formulation of ensifentrine for the maintenance treatment of COPD is in process. It plans to evaluate a metered-dose inhaler formulation as well.
Ensifentrine is an inhaled inhibitor of two enzymes called phosphodiesterase 3 & 4 that have bronchodilator and anti-inflammatory effects. It is being developed to treat COPD, cystic fibrosis and asthma.
Management will host a conference call this morning at 8:00 am ET to discuss the results.
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