The Country of South Korea: Geographic Information

The aim of this article is to sum up all the relevant DueDiligence of the company in one single article. After discussing the value of each drug in the pipeline and giving them the fair value they deserve, we come to the conclusion that BCRX should currently be valued at $184.77. If you are looking for some extensive and detailed DD on the company, i think this is the article you look for, and I highly suggest you keep reading it. In case you find the given information useful, i encourage you to support the article in order to reach more people and rise awareness of how undervalued BCRX is.
If you want to dig deeper, check out u/bio9999 and the community BCRX, some of the informartion related with Galidesivir directly come from bio9999's posts.
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• About Biocryst Pharmaceuticals, Inc.

Biocryst Pharmaceuticals, Inc. BCRX, is a commercial-stage drug developer headquartered in Durham, North Carolina, that focuses on developing oral therapeutics for rare diseases.
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• Unique staff team

The company was founded in 1996 and is currently led by Jon P. Stonehouse CEO, a renowned pharmaceutical executive with over 20 years of thought leadership. Stonehouse previously served as the Senior Vice President of Corporate Development at Merck. Among his numerous accomplishments, Stonehouse was responsible for the game-changing acquisition of Serono S.A in 2007, the largest biotechnology company in Europe at the time.
What makes Jon Stonehouse a unique CEO is the dedication he has towards patients through his commitment to working faster in order to bring life-saving rare disease therapeutics to patient populations around the world. His passion is further substantiated by the note he had pasted on his monitor during the 2021 JPM Healthcare Conference
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• Institutional ownership

Apart from having a stellar management team, what prospective retail investors should also pay close attention to is BioCryst’s rockstar institutional investor syndicate, which includes both generalist industry stalwarts such as State Street/BlackRock and sector-specialist biotech funds like Baker Brothers/Sarissa Capital. Making institutions reach to own 78.77% of the company.
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What should catch investors attention is Alex Denner, head of Sarissa Capital Management recently increasing his stake in the company, managing to own 5% of it. He is one of the most well known biotech investors in the industry. He is the largest inside shareholder of Biogen pharma, ticker BIIB, and notorious for not only finding incredibly deep value in preclinical companies, but for being an "active" vs passive role in their success.
After taking large positions in his value finds, he becomes an advocate for high level decisions from management that unlock shareholder value. He speaks up against possible bad M&A deals and has been known to bring two companies together to facilitate other deals.
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• Pipeline.

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○ Orladeyo ™ (berotralstat) oral pill
Orladeyo is the first Oral approved treatment used to prevent swelling attacks in people with hereditary angioedema (HAE), disease which is estimated to affect 1 in 50,000 people.
Berotralstat is currently approved in two countries, on December the 3rd it got approved by the FDA in USA, and on January the 22nd in Japan. The company expects approval of Orladeyo in Europe to happen early Q2.
Before oral Orladeyo was approved for HAE, patients would only have treatments that required usage of needles. This dramatically reduced the quality of their life, making some of them quit using the treatment. That's the main reason why Orladeyo is a game changer.
After the approval, surveys on patients were done, showing a large number of new patients that were not treated before due to needles, now willing to be treated taking oral form Orladeyo pills.
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As it's shown in the page 13th of the January 2021 Corporate Presentation (page 13), in their recently undergone survey, 59% of the patients expressed high willingness to use Orladeyo, and that number rised to 71% with Physician recommendation.
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Additional surveys were undergone on patients using treatments from the competence "Cynrize, Haegarda, Takhzyro" and the results were the following ones (page 14).
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Number of Patients
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USA
In the USA there are 10,000 patients, 7500 diagnosed and treated, 1700 diagnosed but not treated, 600 treated but not diagnosed.
Physicians expect to prescribe Orladeyo for over 41% of HAE patients. Conservatively thinking, taking 7,500 patients out of the total 10,000 pool in the USA, with over 41% of patients prescription ( page 16 ) we would conservatively aim for 3,075 patients.
Japan
On November the 5th Biocryst undergone an agreement with Torii Pharmaceuticals.
A local Japanese company that will be in charge of getting new patients to be treated with Orladeyo in Japan and commerzialing it.
After Orladeyo received the approval in Japan, Goichi Matsuda, president of Torii said the following words "Until now, HAE patients in Japan had no therapies approved to prevent attacks, so the approval of Orladeyo marks a significant advance in HAE treatment", "We are pleased to have the opportunity to bring the first oral treatment option to Japanese HAE patients and are actively preparing for the commercialization".
Japan has 2,500 HAE patients, and Biocryst conservatively expects to at least reach 500 patients this year.
Europe
It's estimated to be around 12,000 HAE patients in Europe. Following the physician prescription of over 41% of patients to prescribe (page 16) for Orladeyo. We get a total of 4,920 patients in Europe
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Pricings/Revenue
Each patient will have to pay 485K/year to access the drug in USA. In Japan and Europe the pricing system changes since pricing and jurisdictions work in a different way there. Making it 200K/year.
With this yearly prices and the amount of patients defined before, we get the following results.
3,075 x 485K = 1,491,375,000$
500 x 200K = 100,000,000$
4,920 x 200K = 984,000,000$
Summing it all up we get 2,575,375,000$. From that number we have to subtract 74,625,000$ making it a total of 2,500,750,000$. The sustraction happens as a result of the undergone Royalty agreements with Torii Pharmaceuticals and Royalty Pharma.
In the following link, you will have access to a google sheet, where yearly revenues generated by Orladeyo is estimated. A wide range of multipliers regarding the total patient pool that Orladeyo could capture is added, ranging from ( 10%, 20%, 41% and 75%).Revenues have been estimated with the actual price of Orladeyo in 2021 485K/year, it also has an estimation looking forward to 2025, on how the price of the drug will rise due to inflation. Finally there is a chart that gives an idea of what the the market cap could reach to be using revenue multipliers.
Orladeyo value
Having in mind the discussed numbers before, Orladeyo alone will be generating 2,500,750,000$ a year, using the average mid-cap Biotech company multiplier x7. We get a total of 17,505,250,000$, meaning an increase of 99.40$ in the stock price.
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Orladeyo value: 99.40$ SP
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○ Peramivir ™ (Rapivab)
Peramivir (Rapivab) is an antiviral drug for the treatment of influenza. Peramivir is a neuraminidase inhibitor, acting as a transition-state analogue inhibitor of influenza neuraminidase and thereby preventing new viruses from emerging from infected cells. It is approved for intravenous administration.
On 19 December 2014, the FDA approved Peramivir to treat influenza infection in adults. Peramivir has also been approved in Japan and South Korea and is available in Japan as Rapiacta and in South Korea as Peramiflu.
The U.S. government (department of Health and Human Services) gave BioCryst Pharmaceuticals more than $77 million to finish the Phase III clinical development of peramivir. In 2009 the department of Health and Human Services had already given about $180 million to the program.
In 2013 the Biomedical Advanced Research and Development Authority (BARDA/HHS) released new funding under the current $234.8 million contract to enable completion of a New Drug Application filing for intravenous (IV) peramivir.
Rapivab is a bio-defense drug that is often stockpiled by the government. Last time being September the 26th, with a purchase of $14 million.
Peramivir value
With all the explanations given above and having in mind Peramivir is a government bio-defense drug the value of Rapivab can not be less than $750,000,000 conservatively speaking.
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• Peramivir value: $4.258 SP

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○ Galidesivir - BCX4430
The NIAID and BARDA have been funding the development and testing of Galidesivir for over 15 years as they recognize its importance in preparation for all future pandemics. Recently, the 31st of August, 2020 NIAID Awarded $44 Million Contract to Advance Development of Galidesivir.
Besides COVID-19, the world suffers from 200 million infections per year from filoviruses (Ebola, Marburg), flaviviruses (Hepatitis C, West Nile, Dengue, Jap Encephalitis, Yellow Fever, TBEV, OHFV, and Zika), arenaviruses, bunyaviruses, orthomyxoviruses, picornaviruses and paramyxoviruses (think RSV). Galidesivir is the first antiviral that has ever shown such potential, and to top it off, it is now known from the Phase I trial and now the Brazil part 1 trial to clearly be safe and show dose-sensitive effects in people. And based on multiple animal studies, it works equally effectively as a pill that is stable for years at room temperature. Not only that, but this antiviral, unlike any of the others, has excellent penetration of the blood brain barrier as was seen in the macaque Zika virus study.
Efficacy
Phase I safety trials in humans had shown that it was safe and well tolerated .NIAID on April 9th 2020 its expansion of the Brazilian yellow fever trial to include three cohorts of 8 severely affected COVID-19 patients, each being given a different IV dose regimen . Unfortunately, but obvious in hindsight, this trial was from the beginning underpowered to determine a clinical benefit. The patients were followed for eight weeks after their treatments. The company on December 22nd announced that all three doses were perfectly safe for the patients. In addition, they found that patients had a dose-sensitive reduction in virus levels in their lungs. They went on to say that an animal model, which will likely be published shortly, showed that Galidesivir significantly reduced COVID-19-associated lung damage. Despite all this and even though the trial was not even powered to detect a clinical difference in the patients, the NIAID, after finding an insignificant difference in outcomes between the small numbers of drug-treated and placebo-treated patients, inexplicably decided to discontinue clinical trials of it for COVID-19, to the great confused dismay of investors and perhaps even taken advantage of by short hedge funds who brought the stock down in late December. Bear in mind that during this trial, one of the most lethal strains of COVID-19 we know of was affecting the Brazilian trial sites, later known now as the P.1 or Manaus strain, and could have easily negatively affected the clinical outcomes of this small trial too given that the trial was focused on very sick patients more likely to carry this bad strain.
Galidesivir value
First of all, we must have in mind that Galidesivir is a Government funded bio-defense drug, that aims to treat a wide range of viruses as explained before. Its global stockpiling for future pandemics is also an absolute certainty given its long-term stability. With all the explanations being given, conservatively talking Galidesivir can not be worth less than $2.5B, this is 14.20$.
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• Galidesivir value: 14.20$ SP

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○ FOP - BCX9250
FOP is an ultra-rare, severely disabling condition characterized by the irregular formation of bone outside the normal skeleton, also known as heterotopic ossification (HO). HO can occur in muscles, tendons and soft tissue. Patients with FOP become bound by this irregular ossification over time, with restricted movement and fused joints, resulting in deformities and premature mortality. There are currently no approved treatments for FOP.
There are an estimated 3,500 to 9,000 patients worldwide, with 900 diagnosed so far. Currently there aren’t any approved treatments.
Market size for this treatment is estimated to reach 500M-900M in 2025, growing to 3B in 2028 as more patients are diagnosed. With a price ranging from $900K-$1M/year.
Last December the 21st Biocryst announced positive Phase 1 results
“BCX9250 was safe and well tolerated at all doses studied, with linear and dose-proportional exposure supporting once-daily dosing.”.
“In preclinical studies, BCX9250 demonstrated potency for the target kinase, selectivity, safety and strong suppression of HO in animal models.”
BCX9250 Value
BCX9250 study will most likely take 4 years to finish, this is, until 2025. By then the potential market we will be aimming for, will be $750,000,000 aprox.
Drugs that are in Phase 1 studies are said to have a 10% chance of making it to the market. Following that, BCX9250 as of now shuld be valued at $75,000,000 = 0.426$
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• BCX9250 value: 0.426$ SP

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○ Oral Factor D inhibitor - BCX9930
BCX9930 is a novel, oral, potent and selective small molecule inhibitor of Factor D currently in Phase 1 clinical development for the treatment of complement-mediated diseases.
The 3rd of August 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for oral Factor D inhibitor, BCX9930.
Staff excitement
Staff team from Biocryst Pharmaceuticals, Inc seem to be really positive and excited about the incoming future of BCX9930. Such excitement has been seen in the last conference calls where staff members such as the CEO Jon P.Stonehouse, or the Vice President, William P.Sheridan would say the following words.
“Embarrassment of riches”. “We agree with Alexion that creating a potent specific and great oral Factor D inhibitor is a great challenge, and we are happy we have one” , “My only concern is i have no concerns”, “Pipeline in a molecule”, “My aim is to make c5 inhibitors obsolete”, “This is Big”.
Efficacy level
The key for efficacy with this kind of treatment is improving the number of Hb Hemoglobin levels. BCX9930 showed 3.8g/dL improvement ( page 31 ). The competence, Novartis showed 2.87g/dL improvement and Alexion 2.4-2.6g/dL.
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On December the 6th, 2020 BCX9930 data was released showing high potency and specificity for alternative pathway complement.
“BCX9930 monotherapy has the potential to inhibit both intravascular and extravascular hemolysis”,
“In the study, BCX9930 was highly specific for the alternative pathway and, after oral dosing of BCX9930 in primates, alternative pathway activity was completely suppressed.”
“These data demonstrate that BCX9930 is a highly potent and specific orally bioavailable Factor D inhibitor with potential for treatment of patients with PNH and other alternative pathway mediated diseases,” said Dr. William Sheridan”
Alternative Pathway
What makes BCX9930 be a game changer, is the wide spectrum of Alternative Pathway Dysregulation disease it can treat. It can treat up to 8 diseases (page 26) as of now, that is why insiders call it “Pipeline in a molecule”. The diseases it treats are the following ones.
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PNH (Paroxysmal nocturnal hemoglobinuria)
aHUS (Atypical hemolytic uremic syndrome)
ANCA vasculitis (antineutrophil cytoplasmic antibody-associated vasculitis)
Lupus Nephritis
IgAN vasculitis
C3G (Glomerulonephritis)
PMN (Primary membranous nephropathy)
IgAN (IgA nephropathy)
Potential market size by 2025
Assuming BCX9930 will be approved by 2025, and it will be able to treat those diseases, we reach the following conclusion. The potential market size BCX9930 will be aiming for by 2025 scores up to 44.53B/year. Being that number obtained summing up the following ones.
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“"PNH Treatment Market Size Worth $5.8 Billion by 2025"
“"The global systemic lupus erythematosus market size is expected to reach USD 3.08 billion by 2025"
“"aHUS, having in mind the disease prevalence (2 and 5.5)/MM, and the disease being treated with Soliris - 500,000$/ year. The worldwide market size should range between ( $7.5B and $20.5B)" We take 7.5B as conservative.
“"Vasculitis treatment market size forecast to reach $743.2M by 2025"
“"IgAN, having in mind the 1/3,707 incidence rate, and the yearly cost of the drug $12,456 we are aiming for a market size of $4,660,088,544"
“"Having in mind C3G can be treated with Soliris and it costs $500,000 a year. Summing up all those 45,700 patients the market size we aim for is 22.85B"
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All this data can be more detailedly found in the following google sheet mentioned before.
Alexion buy out
On December the 12th, 2020 Alexion announced that AstraZeneca was going to buy them for 39B. More than 90% of their revenue comes from their “Factor D” C5 inhibitor, being that the main reason why AstraZeneca wanted that buy out to happen.
You might think, why does this matter?. Well, remember we have a Factor D which has shown to be more effective than Alexion’s, and is able to treat more diseases than they do aswell. This buy out reflects how undervalued BCX9930 is.
Apart from the buy out, i think it's essential to mention that Alexion bought Achillion's factor D when it was in ph 2 for $930MM.
In 2019 Alexion's SOLIRIS® (eculizumab) net product sales were $3,946.4 million. Soliris is currently approved to treat PNH adn aHUS. Have in mind BCX9930 is able to treat 6 diseases more, aimming for a wider market size, and also having greater efficacy/safety.
Using a biotech mid-cap x7 revenue multiplier 3,964B = 27,748B. meanning a SP value of $157.56 for BCRX. I want to make clear again that BCX9930 is said to be best in-class treatment and it's able to treat more diseases, this numbers could go much higher.
Phase II study
Despite the company not PR'ing the start of the phase II study of BCX9930, the official page of clinacal trials, show that the start of phase II study was December the 18th, 2020. This is extremely bullish since it reasures our thoughts that Ph I data readout will be good and enough to keep the study going.
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BCX9930 valuation
Having in mind BCX9930 is a potential best-in-class treatment, Alexion got bought out for 39B mainly for their “Factor D” c5 inhibitor and the yearly market size it aims for in 2025 rounds 44.53B. BCX9930 valuation can not be less than a 30% of Alexion’s buy out price, this is 11.7B meaning 66.44$. I want to make clear that once the drug is approved and generating revenue, the average x7 revenue can be used, making it much more valuable than it’s now. Do not forget data readout is due Q1.
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• BCX9930 value: 66.44$ SP

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• Strong BO Buy Out candidate

As we have explained in the Institutional section before, all good bio-tech investors do know who Alexander J.Denner founder of Sarissa Capital is. After recently increasing his stake in BCRX, along with BlackRock, he now owns a 5.01% of Biocryst Pharmaceuticals, Inc. Denner, has increased his position in BCRX by an stunning 789% in the last 3 quarters, showing strong conviction in the company.
Since Denner opened his position in Alexion, it took him 5 months to close the buy out deal, as shown in the picture below
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After this exhaustive analysis on the company, we can easily acknowledge that BCRX is more than an strong BO candidate. A buy out coming from BIIB, company where Denner forms part of the BOD board of directors, would make total sense in the following 2 years once BCX9930 Factor D phase II data is unveiled.
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• Alexion's performance with Soliris

As we have explained before, Alexion pharmaceuticals has a Factor D "c5" inhibitor called Soliris.
This company could be the perfect example to have an idea of what we could expect from Biocryst's performance. From 2007 to 2014 Alexion's stock price grew a 1777%. Being valued at 10.5$ in 2007 and 186.6$ in 2014.
Revenue generated by Alexion gradually grew up as their Factor D was approved to treat additional diseases, and the market size they captured got wider.
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Year	Soliris revenue	Stock price	Market cap	Events
2007	66.4 MM	18.6	2.8 B	Soliris approval for PNH
2008	259	18.06	2.95	Split 2:1
2009	368.8	24.5	4.2
2010	541	40.2	7.45
2011	783	74.4	13.10	Split 2:1 Soliris approved for aHUS
2012	1134	97.6	19.5
2013	1551	131.7	26.05
2014	2234	186.6	37.10

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Biocryst Pharmaceuticals stock managing to do the SP move Alexion did, is more than doable with the unique pipeline it has. Having in mind Alexion made 66.4 MM revenue the first year while BCRX at least expects to generate 500 MM with Orladeyo, apart from it, additional revenue generated by Rapivab/Galidesivir stockpillings. Incoming Earning Reports are meant to be potential catalysts for the company, gradually becoming more meaningful as the market size they capture with Orladeyo becomes wider.
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• De-risked company

Last December the 7th, 2020 BCRX announced they made a Royalty agreement with Royalty Pharma and Athyrium Capital Management. With this agreement BCRX was funded with $325,000,000 in order to support Orladeyo launch. Setting the company in an attractive position of not needing to do any more money risings "offerings".
Jon Stonehouse CEO, also confirmed that the company will not need to do offerings anymore. The fact that the company is already generating revenue with Orladeyo is another strong evidence that confirms money risings will not be needed anymore.
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• Conclusion

After this exhaustive analysis, we come to the conclusion that BCRX sitting at $10.30 with a market cap of 1.82B is severely undervalued, and if we sum up the true value of the pipeline, it should be valued at 184.74$, representing a 1793% upside return. This stock price number will keep growing as we keep getting data updates from the on-going studies, making it an excellent long-term hold and buy out candidate.
Once the given information on the company is aknowledged, realizing how heavily the company has been manipulated by institutions, constantly making short pressure bigger in order to move the stock into ridiculous price levels, to be able to accumulate more shares at premium prices. Should not be of anyone's surprise, as this is a true "Embarrasment of Riches", like insiders call it, and they aim to load as much as thay can, at the very best premium prices.
Total value: 184.77$ SP
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