BCRX: The most undervalued stock in the market

 First up, I'm acting as a surrogate for u/BIO9999 as he can't post here yet but is absolutely brilliant and deserves to be heard. He'll be around in the thread to answer questions

We are going to look at Biocryst’s recently approved drug Berotralstat, AKA Orladeyo. It is a once-a-day pill given to patients with a terrible lifelong disease called Hereditary Angioedema, that results in them having to frequently visit the Emergency Room for life-threatening angioedema attacks (check out Youtube for videos of HAE patients suffering from these attacks and using Berotralstat). It is estimated that this disease affects 1 in 50,000 people in the world, or roughly 140,000 people, so although considered a rare disease, it is still affecting a lot of folks.

The available treatments for this disease are all IV drugs that are painful and produce local reactions. Berotralstat is the first oral drug. It achieved excellent results in phase 3 trials, and the US FDA gave it fast track status in 2018 and Japan gave it Sakigake status (type of fast track). Then on December 3rd, the US granted approval for the drug. They did it very importantly with zero label statements--meaning that they had no concerns about side effects or dangers. On January 22nd, Japan granted approval. The EU also met last week to discuss approval and will announce its result this quarter.

So let's look at what the above means for this stock. First the drug is in HIGH demand. In the US there are at least 10,000 people with HAE. Despite the disease being frequently debilitating, patients are so uncomfortable about getting regular injections that only 7,500 are currently being treated with IV injections. The other 2,500 are going untreated despite the high risks. Now let's look at the 7,500 patients on a prophylactic treatment. Based on numerous surveys by doctors, the company, and researchers, most of these people would prefer an oral treatment. Take a look at this peer-reviewed survey article finding that 98% of IV prophylactic patients (the 7,500) would prefer an oral treatment and 96% of the non-prophylactic patients (the 2,500) would want an oral treatment.

No wonder then that one of the preeminent biotech analysts, Evercore's Liisa Bayko, wrote to her clients on December 4th that Berotralstat was likely to quickly take at least 30% of the HAE market based on Evercore surveys of patient and doctor demand.

Remember that this is just the US.... Japan did not even have any prophylactic treatment until Berotralstat was approved there a few days ago. They have 500 people registered with HAE and estimated 2,000 ready to be registered. The UK is so desperate to add the drug for its patients, it did not even wait until the formal approval process to go through and gave early access to the drug on November 9th.

The EU is not far behind, with its estimated 20,000 patients, with approval coming in the next few weeks. Then there is the rest of the world. The HAE patient population in Latin America is estimated by HAE International, the most important advocacy organization for HAE patients worldwide and one of Berotralstat’s biggest supporters, to be over 15,000 patients, the vast majority of whom are poorly diagnosed and not prophylactically treated. Argentina and Brazil have the highest actual diagnostic rates. HAEI through its Latin American sister organizations is strongly advocating for Berotralstat in Latin America.

Next, it should be noted that Biocryst built a world-class sales team for this drug in the US and EU and signed a partnership with Torii in Japan to take charge of the large sales and marketing promotion there. It has hired dozens of professionals, most from its HAE competitors. Its vice-president and US general manager Allen Hodge was even responsible for the successful efforts of the HAE drug launches of Cinryze and Firazyr, two pioneering injectable treatments for HAE. You could not get a more promising leader for this task.

It should also be pointed out that this drug, an oral kallikrein inhibitor, is potentially of huge value for a host of diseases, including COVID-19 (that is now recognized to severely affect the kallikrein-kinin system, and kallikrein inhibitors have begun to be tested against COVID19--see this (IV) kallikrein inhibitor trial that was just announced in Brazil for instance: https://pubmed.ncbi.nlm.nih.gov/33472675/), diabetic macular edema (which Biocryst just obtained a patent on a technique to administer kallikrein inhibitors for), many autoimmune diseases, and even some types of cancer.

Last but not least, how should this stock be valued based on this one drug? First, this drug is one of the 10 most expensive drugs (based on its annual cost of prescription) in the world, but still less than the price of its IV competitors, at $488,000 per patient per year. This drug is being approved by insurance companies left, right, and center as their preferred treatment, all you have to do is follow R8 or nickpd on Stocktwits to see how many insurance companies have been making it easy for patients to sign up for the drug. Optime care even lets patients get direct-to-patient prescriptions now.

So what does all this mean for sales? And why is the stock not valued based on just this drug alone (I will get to the others in future posts)? I estimate conservatively that by December 2021, there will be over 6,000 patients on Berotralstat in the US, EU and Japan, and I can share in a future post the graphs and calculations I made to get to those numbers. 6,000 patients annualized is up to $2.9 billion in annual sales. Most of this is going to be profit. At a conservative price to sales ratio of 7, that should produce a price of $121, not $8.52! If you want to play around with the math yourself, look here.

And that is just the beginning. Because Factor D and Galidesivir are going to be much bigger than Berotralstat for reasons I will explain in future posts. Remember that its Factor D drug, which is showing superiority to all other anti-complement drugs in Phase I trials and was fast-tracked and given orphan status by the FDA and now is in Phase 2 though not officially announced by the company eyt, and can be used in at least 20 diseases including common ones like Rheumatoid Arthritis, is currently not even factoring into BCRX's valuation. Consider that Alexion with its significantly inferior anti-complement drug was just sold to Astra-Zeneca for $39 billion because of the recognized potential of anti-complement drugs for a host of diseases. BCRX even has has other drugs like Peramivir, already approved for Influenza and able to be used for the next bird flu pandemic, and its FOP drug--a story for another day.

So why is this company, with zero risk of dilution due to an amazing royalty deal it signed in December and three super-drugs each worth tens of billions of dollars, and a host of other exciting developments to look forward to, worth only $1.5 billion right now? It can only be because the company's stock has been relentlessly shorted in 2020 and 2021 to allow for significant accumulation by institutions. That is why the stock only went up 168%, yes "ONLY" 168%...

The time for BCRX investors is now. My next post will be about Factor D, brace for that one. Factor D is 10 times bigger than Berotralstat! Good luck to all!

positions: 1 GME share, 1700 BCRX shares. buy either and profit. not financial advice though.

https://www.reddit.com/r/wallstreetbets/comments/l8xiqh/bcrx_the_most_undervalued_stock_in_the_market/

Soliton: FDA OKs Rapid Acoustic Pulse Tech for Use in Cellulite

 Soliton, Inc., (Nasdaq: SOLY) ("Soliton" or the "Company"), a medical device company with a novel and proprietary aesthetic platform technology, today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Rapid Acoustic Pulse ("RAP") technology for the short-term improvement in the appearance of cellulite. This innovative technology harnesses the power of sound for the treatment of cellulite. The unique, rapid-pulsed technology safely and comfortably breaks apart the fibrous septa bands beneath the skin that cause cellulite to deliver efficacious results in just one, 40–60-minute treatment.

"We're thrilled to receive this latest clearance for our RAP technology," said Brad Hauser, President & CEO of Soliton. "Our technology will now provide physicians a new, innovative and non-invasive approach for patients seeking a non-surgical option to improve the appearance of cellulite. This latest clearance also marks the next step in the planned commercialization of our RAP technology, and we look forward to introducing this new approach to treating cellulite to physicians in the months to come." 

https://www.prnewswire.com/news-releases/soliton-announces-fda-clearance-of-rapid-acoustic-pulse-technology-for-use-in-cellulite-301218525.html

Zosano Presents Early-Onset of Action Data for Qtrypta™ in Migraine

 

• Review of data from the ZOTRIP trial suggest that Qtrypta showed therapeutic gain at 30 minutes consistent with recently published criteria for evaluating early onset of action
  
  
• All Qtrypta patients who were pain free at 30 minutes were still pain free at 2 hours
  
  
• Observation of pain freedom at 30 minutes was more accurate than the observation of relief at 30 minutes in predicting pain freedom at 2 hours

https://www.globenewswire.com/news-release/2021/02/01/2167325/0/en/Zosano-Pharma-Presents-Early-Onset-of-Action-Data-for-Qtrypta-in-Acute-Treatment-of-Migraines.html

Ampio: Early Positive Data in Phase 1 Ampion in COVID-19 Respiratory Distress

 - Subjects who received Ampion treatment required less oxygen than standard of care alone.

- Subjects who received Ampion treatment were stable or had improvement on the Ordinal Scale for Clinical Improvement (Ordinal Scale) compared to the standard of care patients.

- Subjects who received Ampion treatment were stable or had improvement on the National Early Warning Score 2 scoring system (NEWS2) compared to the of standard of care patients.

- Ampion improved all-cause mortality in COVID-19 patients with respiratory distress compared to standard of care.

- There have been no drug-related serious adverse events.

- Ampio has inventory on hand. In event the safety and efficacy study is successful, and the product receives regulatory approval, Ampio is in a position to begin immediate manufacturing.

https://www.prnewswire.com/news-releases/ampio-announces-early-positive-data-in-phase-1-trial-of-inhaled-ampion-in-covid-19-respiratory-distress-301219046.html

Covid-19 Vaccines to Stress-Test Grocery Stores and Pharmacies

 Some of America's biggest retailers are preparing to take a central role in administering Covid-19 shots, hoping to avoid logjams and other complications that have slowed the vaccine rollout's early days.

The U.S. fell far short of its initial goal of inoculating 20 million people by the end of 2020, with health departments, hospital systems and long-term-care facilities beset by supply-chain bottlenecks, vaccine hesitancy and confusing, scattershot systems for making appointments.

Not all Americans are eligible for the vaccines, and shots remain in short supply. But vaccines are becoming more broadly available in some states, and the federal Centers for Disease Control and Prevention aims to make them available in local pharmacies beginning next month. There is no cost to receive the vaccine.

The job of vaccinating large swaths of the population will fall largely on retail pharmacies, with companies such as CVS Health Corp., Walgreens-Boots Alliance Inc., Walmart Inc. and Kroger Co. saying they are prepared to give tens of millions of shots a month.

"We're going to have to look at ways to increase our access points. We've got to be able to step up the pace to vaccinate people across the country if we want to make a dent in this," said Bart Buxton, co-chair of the Covid-19 vaccine taskforce for McLaren Health Care Corp. The Flint, Mich.-based hospital system teamed with Walgreens to administer doses to its 26,000 employees as part of the first phase of vaccinations.

Hospitals and health systems, already overwhelmed by treating coronavirus patients, can't also bear the brunt of vaccinations, Mr. Buxton said. "Health systems like McLaren can't do this by themselves."

Pharmacies are well-positioned to play a major role in Covid-19 vaccination efforts, industry executives say, because they are among the most-accessible health-care providers for many Americans, including people 65 and older who often pick up medication from local supermarkets or drugstores. These businesses say they also can draw from their experience in providing shots for flu, shingles and other illnesses.

CVS and Walgreens combined have 19,000 U.S. stores, while Walmart, Rite Aid Corp., Kroger and Publix Super Markets Inc., together have another 11,000 locations. Add to that dozens of regional grocers with pharmacy counters.

CVS says it can vaccinate 20 million to 25 million people a month once supplies are available. Walmart said in January that it would be able to vaccinate 10 million to 13 million a month.

President Biden said last Monday that his target of administering 100 million Covid-19 vaccines in his first 100 days in office might rise to 150 million. As of Friday, 27.9 million shots had been administered, out of 49.2 million distributed since mid-December, according to CDC data.

Drugstore chains and retailers with pharmacies say they have the manpower and physical space to handle mass vaccinations and, in some areas, have already stepped in to help local and state officials. Big chains say they have online scheduling tools capable of handling an influx of appointments.

Walgreens has said it plans to hire about 25,000 people across the U.S. to administer the vaccine. It employs 75,000 pharmacists and technicians. CVS, which employs 34,000 pharmacists and 65,000 technicians, declined to say how many workers it is hiring.

Among the biggest challenges now for retailers is dealing with customers eager to know when it's their turn.

"We're doing everything in our power to avoid confusion about how to get vaccinated," a CVS spokesman said. In addition to long-term care facilities, the drugstore chain is offering shots to select groups in Indiana, Massachusetts, New York and Puerto Rico. People eligible for a vaccine must make an appointment.

"We answer that question dozens, hundreds of times a day," Charlie Hartig, chief executive of Hartig Drug Stores, a small Midwestern chain, said of the question of vaccine availability. "Education is taking up time."

Associated Food Stores, a cooperative of more than 400 supermarkets and nearly 40 pharmacies, is working through how its staff will report vaccinations and quickly process claims.

For Associated Food, scheduling has been an area of focus, said Chris Sheard, who oversees pharmacy operations at the company. Its pharmacies have largely operated on a walk-in basis and now are asking customers to schedule appointments for Covid-19 vaccines so it can ensure distancing and cleaning.

"People would walk up during their lunch break. We can't do that now," Mr. Sheard said. The company is trying to get the word out by increasing marketing and social-media efforts, and by providing wait lists where people can sign up.

Others are hunting for space to give out inoculations and partnering with organizations to set up mass vaccination events. Iowa-based grocer Hy-Vee Inc. is working with a local university to set up vaccination stations in a 16,000-square-foot facility, Aaron Wiese, chief health officer at the company, said.

"You're looking at a significantly greater number when you're saying 65 and up and people with underlying conditions," Mr. Wiese said. "Add on other essential workers, you're going to need more capacity."

Hy-Vee plans to use greenhouses, which are temperature controlled and suitable for larger groups. The retailer also started testing so-called waiting pods, where customers can wait after receiving vaccinations, and RVs with exam rooms. Hy-Vee plans to deploy RVs when it goes to manufacturing plants to immunize staff there, Mr. Wiese said.

Mass vaccinations will require a robust online-booking system, said America Davis, communications coordinator for Immunize Nevada, a nonprofit that has set up a website to schedule appointments in the state. It has been scrambling to keep the site working amid crushing demand.

"Health and local officials are literally working around the clock to be sure we're doing this right," she said. "I don't think anyone anticipated just what the uptake of this vaccine would be."

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/Covid-19-Vaccines-to-Stress-Test-Grocery-Stores-and-Pharmacies-32324502/

Bristol Gets FDA Priority Review of Zeposia in Ulcerative Colitis

 Bristol Myers Squibb Co. on Monday said the U.S. Food and Drug Administration accepted its application for expanded use of Zeposia in adults with moderately to severely active ulcerative colitis.

The New York biopharmaceutical company said it redeemed a priority-review voucher with the submission, resulting in an FDA target action date of May 30.

Bristol Myers said Zeposia, if approved, would be the first oral sphingosine-1-phosphate receptor modulator for the treatment of ulcerative colitis, a chronic inflammatory bowel disease.

Bristol Myers last year received U.S. and European approval for Zeposia in adults with relapsing forms of multiple sclerosis. The company is also evaluating the drug as a treatment for Crohn's disease.

https://www.marketscreener.com/quote/stock/BRISTOL-MYERS-SQUIBB-COMP-11877/news/Bristol-Myers-Squibb-Gets-FDA-Priority-Review-of-Zeposia-in-Ulcerative-Colitis-32325902/

AstraZeneca See Receiving Up to $780M From Viela Stake Divestment

 AstraZeneca PLC said Monday that it has agreed to divest its 26.7% ownership in Viela Bio Inc. as part of the proposed acquisition of Viela by Horizon Therapeutics PLC, and said it expects to receive cash proceeds of up to $780 million.

The British pharmaceutical major said the divestment is expected to complete by the end of the first quarter of 2021.

AstraZeneca said it is anticipating to receive cash proceeds and profit of between $760 million and $780 million upon closing for the sale of the holding. The divestment doesn't hurt its guidance for 2020, the company said.

Horizon Therapeutics earlier on Monday said that it has agreed to acquire Viela for $53 a share in cash, or an equity value of about $3.05 billion.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-Expects-to-Receive-Up-to-780-Million-From-Viela-Stake-Divestment-32325735/