Holding BCRX, LJPC and GRTS. Monitoring for another opportunity to load NGM. Core Positions = stocks with the most attractive risk vs reward profiles. We concentrate our capital in these stocks and swing and day trade other stocks with`~1-10% of our total portfolio value.
- News feels imminent. The way BCRX is trading right now is remenicent of when it was pinned at $2 in early April just before the company announced its COVID study in Brazil. Interestingly, the number of share available to borrow on interactive brokers has not been at the level its at now since that time. Furthermore, the interest fee to borrow shares is extremely low. Furthermore, the average short-sale volume for the past 50-days is 48%. This signals, in our view, that the stock is being shorted in a very precise manner in order to keep the price supressed, just like it was in early April.
- Numerous near-term catalysts are looming. There are also many unscheduled catalysts that could drop such as animal data for galidesivir in Primates infected with COVID. Furthermore, it seems now that BCRX has the best oral factor D inhibitor out there. This is clearly not factored into the company’s valuation as its market cap is under $700M and considering Alexion (AXN) paid nearly $1B last year to acquire Achillion Pharmaceuticals (ACHN)’s oral factor D inhibitor. We learned recently to that it was discontinued from clinical development to due a lack of efficacy.
- With 30M shares short there is an excellent setup for a short squeeze.
- During the 2Q20 conference call we learned that galidesivir has a half life 4X that of remdesivir. We further learned the company is planning to meet with the FDA soon to discuss late-stage development of BCX9930 (factor D inhibitor). Management eluded to non-dilutive financing options including partnerships and royalty financing. Data on the galidesivir-COVID study will be announced at the end of 3Q20 (i.e. the end of December). This data will inform what dose they select for Part 2 of the study. Additional clinical data on BCX9930 will be shared by the end of 3Q20 as well.
- Sultan published his latest research into BCRX and its oral preventative HAE therapy (Orladeyo)
- Found the common drug application submitted to the Canadian regulatory authorities for approval of Takhzyro in Canada. Takhzyro is one of the top preventative medications on market. Reading through it bolsters the bull thesis for BCRX and Orladeyo. I highly recommend reading through it.
- Announced fast track designation for BCX9930 in PNH on 8/3/20
- There has been a lot of clamor about President Trump’s visit on Monday to Fujifilm Diosynth Biotechnologies (FDB) manufacturing facility in Durham NC, which is right down the street from BCRX HQ. FDB was contracted by NVAX to produce the components needed for its vaccine in it’s Phase 3 study.
- Interestingly, it turns out that NVAX CEO Stanley Erck used to serve on the board of directors for BCRX. Per the latest SEC filings before he stepped down in late 2018, Stanley held 48K shares of BCRX common stock.
- In the press release announcing his departure it was noted that he was not leaving due to any disagreement with the company
- Click here to watch a recent discussion with Dr. Schramm in regards to COVID-19
- Broke $5 support earlier this week. The selling pressure was in part due to a sector rotation of funds out of the NASDAQ. Our thesis remains firmly intact.
- A new article was published highlighting the correlation of BCRX and Galidesivir with GILD and Remdesivir.
- Dr Kallas (the lead investigator on BCRX’s COVID-19 trial in Brazil presented at a virtual conference this evening. He mentioned Galidesivir briefly stating the trial was progressing)
- NIAID is reported to have ordered $18k worth of Galidesivir through a vendor on June 10th, the same day BCRX announced Galidesivir had positive Zika data
- A study published in the Journal of Virology showed that Galidesivir was provided protection in mice to tick-borne encephalitis virus (TBEV) genetically engineered to be resistant. This supports the thesis that Galidesivir has a robust mechanism of action that is difficult for virus mutation to overcome
- This study provides the structural basis of how RNA-nucleoside s like Remdesivir and Galidesivir inhit RNA virus replication
- The company recently announced that Galidesivir stops Zika viral reproduction in a primate model.
- Announced that Orladeyo (formally called berotralstat) will be made available to patients in the U.S through an Expanded Access Program. This means that patients with HAE can obtain the drug through their doctor without needing to be enrolled in a clinical trial
- Click here to read Chris Stang, PharmD’s new article on BCRX!
- Announced new data over the weekend for berotralstat (now called Orladeyo) that was presented at the EAACI conference this weekend in Europe.
- 48-week data showed robust and durable reductions in HAE attacks and increases in quality of life scores in patients taking Orladeyo.
- Two patient surveys presented showed high market receptivity for Orladeyo and favorable market conditions with respect to existing therapies
- Presented at the Jefferies Health Conference last week. The executive team discussed their plans and excited for launching the company’s first commercial product Berotralstate (now branded as Orledayo). Click here to listen to the webcast
- Closed an offering on 6/1 securing $115M and raising their cash position to ~$215
- At the RBC Capital management stated they are getting significant help from the government for developing galidesivir for COVID-19 Click here for the webcast
- Reported strong earnings on 5/6/20. Highlights from the report were positive phase 1 data for their Factor D inhibitor, remaining on track for 3 commercial approvals for their lead asset, and the expansion of their COVID-19 trials to 4 sites in Brazil.
- Click here and go to hour 1.47 to hear Dr. Esper Kallas (the lead investigator BCRX’s CV19 clinical trial) talk a little about Galidesivir as a potential treatment for CV19.
- Dr. Dena Grayson mentioned Galidesivir during an interview on Fox News this weekend. She mentioned she spent years developing it and that its currently being tested in a clinical trial in Brazil as a potential CV19 treatment.
- FDA awarded Emergency Use Authorization (EUA) for GILD’s Remdesivir for treating CV19. Galidesivir is a similar antiviral but as we argue is chemically and structurally superior
- PT= $10-20+
- Held up well today considering that most biotech stocks got hit hard. LJPC actually was green for most of the day.
- Tumbled over 15% on weaker than expected 2Q20 earnings ($5.8M in revenue from Giapreza vs $7-8M expected). We suspect that the decrease in revenue compared to 1Q20 is due to a decrease in elective and open heart surgeries due to COVID
- We see no reason to take a loss here. In our view, Tang will handle business. The timeframe for LJPC has been longer than we hoped but we are confident there will be another pump where we can exit with profit. Giapreza is a great drug that is garnering increased support among critical care professionals. Given that a year ago before COVID-19 net sales revenue was in the $5M range indicates demand is growing. If it was not, then we expect net sales revenue to be $1-2M with COVID and the decrease in elective and open heart surgeries.
- The stock has trended up this week after announcing the closing of the acquisition of Tetraphase Pharmaceuticals (Nasdaq: TTPH) and appointing former TTPH CEO Larry Edwards as President and CEO of LJPC.
- We are anticipating continued momentum into earnings
- Click here to read our latest article on LJPC discussing its decision to acquire TTPH
- Per the agreement LJPC will acquire Tetraphase Pharmaceuticals for $43M in cash plus an additional potential $16M in contingent value rights based on revenue milestones being hit. Stay tuned for an article diving deeper into the acquisiton.
- Kevin Tang (board chairman and majority shareholder) reported buying 615K shares on the open market last week at an average share price around $4.90 ($3M transaction)
- A commercial restructuring plan was approved in late May by the board of directors to focus the company’s resources on Giapreza. Per the restructuring plan, the CFO and CSO are leaving the company.
- LJPC declined over 30% after Amivas LLC beat LJPC to punch in getting Artesunate approval. Click here to read more (BCRX discussed in this article too)
- Reported 1Q20 earnings on 5/4/20. Highlights were significantly reduced operating costs, a beat on EPS by a wide margin, and healthy revenue growth from Giapreza.
- Half of the patients included in an Italian study were given Giapreza.
- Since 3/13/20 Giapreza has been made available by request at hospitals in the UK, Germany, Belgium, and Italy for the treatment of septic shock associated with COVID-19.
- A potential near-term catalyst is if the company announces a commercial partnership in Europe where Giapreza was approved in late 2019.
- PT= $8-12 (3-12 months)
- Monitoring for a dip below $18 to start a positon
- Major stakeholder David Goeddel of the Column Group reported buying another 3000 shares at $17.99 earlier last week. Then today Peter Svennilson and The Column Group reported buying 4015 shares at $17.99. This indicates to us that $18 is the floor (barring another market wide sell-off or negative development) and that The Column Group will continue to support the share price by purchasing whenever the stock falls below $18.
- Ultimately, we think NGM will be a huge success. Just because we are personally selling does not reflect any pessimism. We’ve simply realized significant gains and see better near-term growth opportunities elsewhere (i.e Corbus).
- Filed a Form S-3 (shelf registration) last week to sell up to $400M in stock
- Reported 1Q20 earnings on 5/13 showing $328m on hand.
- Has a deep clinical pipeline with 6 assets targeting diverse indications of high unmet needs. Phase 2b data in patients with NASH cirrhosis is expected 1H2021
- Since 4/1/20 insiders (the Column Group) have collectively bought 1.5M shares of NGM at an average price of $13.94. They now own 17.7M shares (~30% stake)
- PT= $30+ (0-12 months)
- Presented at the BTIG Biotech Conference today. Click here to listen to the webcast
- We learned earlier this week that a major shareholder (FMR/Fidelity) sold half of their stake.
- Reported earnings earlier this week, click here to read them
- Presenting on 8/11 at the BTIG Biotechnology Conference.
- The company is definitely undervalued. We will continue to exercise patience until the price finally rebounds
- Sold off 50% on what appears to be an overreaction to underwhelming data. This is a good example of why we like to de risk from time to time going into events.
- If the company plans to proceed with a COVID program the share price should jump to $20-30 per share. We encourage everyone to email the company suggesting this (firstname.lastname@example.org)
- The prospects of a COVID program at this point look bleak.
- Officially announced on 6/24 that the company will be giving an update on its SLATE and GRANITE clinical programs on 7/13 to investors via webcast. During the call plans for a Phase 2 study will also be discussed
- SLATE and GRANITE are Phase 1 studies investigating the company’s proprietary ‘personalized’ cancer therapy platform.
- Reported 1Q20 earnings on 5/7/20. Highlights include anticipated phase 1 efficacy data mid-year, initiating two Phase 2 studies, and plans to nominate a new clinical drug candidate.
- Appointed a new director to the board recently with an intriguing background as an executive in the healthcare investing arm of Pfizer as well as private healthcare-focused venture capital firms.
- PT= $10-15 (0-12 months)
MS Money Move and its Officers, as well as its affiliates are not registered financial advisors. Our posts should serve as educational material to help you conduct due diligence research. Posts and articles are not directives or recommendations to invest in any security. We reserve the right to buy or sell any security for ourselves without any notification except when required by law. We are not responsible for the action of our affiliates. Investment theses may change due to the variable nature of the securities market. Because of this there is great risk when investing in stocks and options which can result is capital loss. Additionally, past performance by MS Money Moves or any security is not a predictor of future performance. Everyone should conduct their own research and due diligence before making an investment decision. We recommend you consult a financial advisor regarding any investment action.
The biotech sector is especially volatile. Stock prices may fluctuate substantially based on material or nonmaterial developments. We encourage everyone to familiarize themselves with clinical trial processes, relevant terminology, FDA/SEC rules and regulations, and the general processes of drug & therapy development/approval. Always do independent research in a security prior to investing.