Core positions are stocks that we feel have the most favorable risk-reward profile. We concentrate our capital in these companies and hold for anywhere between 3 and 6 months seeking 100-500%+ returns. We provide updated research reports as the investment progresses, be sure to stay tuned for the new reports. We like to trade the ranges from time to time to protect profits and avoid bag holding.
*We are monitoring for activity on LJPC and will load the boat if given the opportunity in the $3s. Anticipated earnings is some time in the first week of March
*The XBI has receded 20% since February 9th. Due to the massive drop, many individual stocks are taking a substantial beating. During times like this we traditionally try to consolidate in positions we are most comfortable with such as BCRX and have some cash ready to buy stocks that get disproportionally effected. While the beatdown has been immense, historically things turn back around. If your thesis hasn’t changed on a stock, but the price has gone down, we often find ourselves weathering the storm. Feel free to contact us on our email or in the chat for any questions or insights on our personal strategy
Core Positions: 3/04/21
- Added to position again today in the high $10s as shares dipped due to the broader markets
- Participated in Cowen’s 41st Healthcare Conference today, for a transcript click here
- Cowen initiated a $16 price target based on Orladeyo alone, noting $25+ potential if the rest of the pipeline performs. The report was more than 50 pages, a unique report coming from analysts when most release a short thesis. Cowen utilized consultants and a widely skilled team to verify the potential for Orladeyo and concluded that $600m+ is within reach
- They believe 50% market penetration is in reach
- Bofa updated their BCRX standing with a $13+ price target and a peak sales forecast for Orladeyo to $640m from $400m
- Since February 8, 2021, the XBI has receded from nearly $180 to $130. During this time BCRX has demonstrated strength
- Submitted marketing authorization in the U.K. for Orladeyo as EU approval looms
- An S-3ASR on 3/01/21 surfaced. S-3ASR are an automatic shelf registration. Overall we believe the likelihood of dilution near term is low as last weeks call management revealed substantial cash and said they “have many levers to pull.”
- Received a positive opinion from CHMP for Orladeyo, suggesting a high likelihood of EU approval where Orladeyo has orphan drug designation (exclusivity)
- Received an upgraded price target from Piper to $15 which was a 50% increase
- Earnings announced 2/25/21. This report was inline with our expectations. Shares recovered over $11 earlier in the day but sold off as the market in general got beaten up. Overall we found that management displayed confidence in Orladeyo sales, upcoming Factor D data and reaffirmed our thesis. We are continuing to add significant dips.
- $303 million, providing runway to 2023
- BCX9930 dose ranging trial has fully enrolled 16 patients, data to be presented March 22, 2021 at R&D day
- For a link to todays transcript and conference call, click here
- Sheridan had a form 4 surface, revealing a pre planned sale, this doesn’t change our thesis
- A form 4 surfaced for BABU YARLAGADDA on 2/23/21
- Marburg trial was marked as completed, leaving some bulls to speculate on the possibility of Priority Review Voucher down the road
- BCX9930 trial was updated on 2/19/21 revealing the trial was marked completed January 25th, 2021 and increased patients from 148 to 168
- Presenting at conferences on March 11th
- Several 13G’s surfaced, revealing increased stakes from places like Blackrock
- 13G surfaced revealing Vanguard has increased their stake (2/10/21)
- P2 KALV data surfaced. In our opinion this data looked to be cherry picked and is still a far ways off from materializing into a concern for Orladeyo. Patients largely utilized rescue treatment and several other holes which make the data unconcerning to Orladeyo market stake in our opinion
- Announced a label extension for Rapivab for patients 6 months and older (2/3/21)
- For an updated research report published 1/31/21, click here
- Sarissa Capital revealed a 4.5m share add to their position, bringing their total up to 5% ownership in BCRX as per a 13G filed. We believe this demonstrated confidence in the future value of Biocryst
- Orladeyo is now approved in Japan, granting access to 2,500 patients who have no other treatment options and also triggering $15 million cash upfront from our partner (Tori) as well as high royalties
- Click here for the JPM webcast transcript
- Presented at JPM, highlighting a strong financial position through at least 2023, anticipating Japan approval this month (our guess is roughly January 23rd based on historical PMDA approvals in January) and more. Stonehouse also emphasized the 2500 known patients in Japan which have no current solution on market. BCRX received a $15 million milestone payment from Tori once/if approved and Japan as well as royalties.
- Dr Marc Riedl, MD Ms KOL HAE and other respected workers in the space have begun to express their enthusiasm as for Orladeyo. We perceive this as bullish as these people work with patients on a daily basis
- Awareness of HAE continues to grow with sites like “Pharmacytimes.com” recognizing Orladeyo as a significant step for patients
- Ultimately we see a future for Galidesivir and stockpiling under other indications as it remains to be a valuable antiviral
- Released Phase 1 news for BCX9250 trial in FOP yesterday saying the drug was found to be safe
- A flurry of Form 4s in the form of option exercises and more took place last week, potentially suggesting the floor is setting in
- Presented at JMP Securities Hematology Summit, highlighting excitement for their Factor D asset
- Announced $325 million royalty financing deal from Royalty Pharma and Athyrium Capital Management. The deal includes $125 million upfront in cash, reducing the possibility of near term dilution and features 8.75% on the first sales up to $350 million, 2.75% on sales $350-550 million, tiered percent for certain territories and 1% on global net sales of BCX9930 if approved. We want to highlight that this deal is almost 1/2 of what BCRX’s market cap was about a week and a half ago and conveys a strong message of optimism for their upcoming sales which have likely already begun.
- FDA proved Berotralstat! $485k/ annual per patient
- ReleasedFactor D presentation on Sunday at ASH
- Evercore ISI initiated a buy rating and $12 price target
- Several directors took common stock awards as opposed to cash payouts in the form of form 4’s
- 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.
- 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
- 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
- PT= $15-30+ (0-6 months)
- Held up well on above average volume (3/04/21) amidst the bloody markets demonstrating strength in our opinion
- Received news 3/03/21 that Kiniksa’s subsidiary in the U.K. has reached commercial supply agreement with Regeneron Pharmaceuticals, Inc., under which Regeneron has the exclusive right to manufacture and supply rilonacept for Kiniksa U.K.’s requirements.
- Announced the launch of the RESONANCE registry in pediatric and adult patients with recurrent pericarditis
- For our most recent report on KNSA, click here
- Added to position on Friday (2/26/21) under $20
- Purchasing shares under $21 in anticipation of a PDUFA run up. Our buy zone is $18-21
- Released earnings 2/23/21
- Ended 2020 with $323 million in cash and equivalents
- Clinical data from KPL-404 (anti-CD40) Phase 1 clinical trial and mavrilimumab Phase 2 clinical trial in severe COVID-19 anticipated for 1H 2021
- PDUFA anticipated for 3/21/21 with a priority review voucher. We consider de risking going into material events when we are over exposed or nervous
- PT = $30-40+ (before 3/21/21)
- Moved our entry target range to sub $20 due to the market conditions
- Participating at H.C. Wainright March 9th 7AM EST
- After receiving approval on February 12, 2021, the company announced 3/02/21 COSELA™ (trilaciclib) for injection is now available in the U.S
- Earnings 2/24/21 revealed:
- $207.3 million cash & equivalents with operating expenses of $40.63 million
- Provided updates and color on commercial launch as well as a conference call
- Nearing our re entry target, we are monitoring for $20-23 re entry range
- Received FDA approval of COSELA after hours on Friday which pushed shares up 20% in after hours trading
- Shares were beaten down in 2/16/21 session, going from mid 30s to down -9% in the high 20s. We are monitoring for an area to add
- New core position, read our research here
- We are bullish on the overall science and management of this company
- Entered in the low teens and have been building position on significant dips
- PT = $30-45 (1-6 weeks)
- While no negative news has surfaced, KPTI has fallen victim to immense shorting, coupled with the XBI’s 20% sell off since mid February. The short interest currently sits at about 28% which partially suggests why the sell off has been relentless. We believe share price will recover it’s just a question of how long we are willing to have capital tied up in the position
- The next catalyst is earnings in April/May or unscheduled events like a European partner
- Announced inducement grants 3/01/21
- Several insider transactions surfaced 2/17/21
- Released Q4 earnings 2/11/21
- XPOVIO net product sales $20.2 million for Q4, 76.2 million for year 2020
- $35.1 million for Q4 2020 and $108.1 million for the Year 2020
- Positive CHMP Opinion for NEXPOVIO® with European commission decision expected by April 2021
- (2/2/21) we added to our position in the mid $14s. We are keeping a close eye on short interest to help guide our entries
- Another new core position we have been building in the low $14s
- Read our new research on why they are a core position here
- PT = $18-25+ (1-6 weeks)
- Sold off heavily with the market today. Shares blew through $1.70 support but recovered over it. We are monitoring for strength to indicate a reduced risk entry
- Presenting at H.C. Wainright 3/09/21 7AM EST
- Continuing to treat under $2 as a load zone
- Healthy pullback after a monstrous run to $3 recently, monitoring for re entry under $2
- Recently enrolled the final patient in VAL-083 study
- Recently announced the initiation of patient recruitment for VAL-083 study arm in the GBM Agile trial
- KZA & KTRA activated Kazia’s paxalisib and Kintara’s VAL-083 in GBM AGILE
- For Sultans updated research on KTRA, click here. Updates are in progress to this research. You can see when the article was last updated at the top of the page
- Released earnings recently, revealing cash and equivalents of $22.6million as of September 30th
- We maintain our stance that KTRA is undervalued and should have a market cap of at least $100M (currently $60M fully diluted)
- PT= $2.50-3+ (1-3 weeks)
- Continued the sell off with the rest of the market, thesis unchanged
- Released data from 998 users with type 2 diabetes which revealed increased digital engagement resulted in 43% improvement in blood glucose levels
- Reporting earnings on March 19th
- Announced acquisition of musculoskeletal company, potentially paving a path to billion + territory. The story continues to get better for those that can stomach the volatility in between in our opinion.
- Several mixed form 4s surfaced
- Bought the dip after DRIO announced that it inked a contract to provide its DTx solution to eligible employees of a U.S.-based Fortune 500 tech company
- For those of you unfamiliar with the Dario story, Dario Health (DRIO), the company markets its digital health platform through a SaaS (software as a service) model for the management of chronic conditions such as diabetes and hypertension. For an overview of DRIO’s value proposition click here for our original research. Updated research coming soon!
- Has had a continuous flow of positive material developments this year including a partnership agreement with Vitality Group, assembling an elite C-suite team, and expanding its service offering into the behavioral health and telemedicine market.
- This summer DRIO continued its momentum. In June they presented new clinical data at the American Diabetes Association’s (ADA) Scientific Sessions demonstrating that proper management of blood sugar and blood pressure through its platform translated to improved clinical outcomes.
- DRIO further commenced enrollment on two remote patient monitoring agreements (which include Medicare billing codes) providing a turn key solution for physicians amid the pandemic, appointed veteran healthcare plan executive Dennis Matheis to DRIO’s board of directors, and closed a $28.6M private placement with institutional and healthcare focused investors at $7.94/share
- Since the deal closed the market has reacted favorably propelling DRIO over 70% as of today’s closing price.
- Per comments made by DRIO’s President and General Manager of North America Operations Rick Anderson in today’s 2Q20 earning call, the company is in late stage discussions with several payers, employers, and health plans which are projected to come to fruition in the coming months. One of these contracts was described by Rick as “Jumbo”.
- We anticipate further upside this year in DRIO driven by continued execution on its B2B2C (business to business to consumer) commercial strategy. Guidance given by Rick puts the annual revenue opportunity at $200M/year (vs. $1.7M in 2Q20)
- PT = $25+ (0-3 months)
- 10Q released 3/04/21
- $295.2 million cash & equivalents, not including $134.7 million from recent offering in January
- Anticipating data from Phase 2b ALPINE 2/3 trial in Q2
- Announced 3/02/21 that they have dosed the first patient in an expansion of its ongoing Phase 1b proof-of-concept study of NGM120 in patients with metastatic pancreatic cancer
- Monitoring for opportunities to add sub $25
- Presenting at Cowen 41st Healthcare Conference on March 4th 11:10 AM EST
- Column group and Goeddell have been slapping shares over the past year
- Announced updated 2021 priorities for their pipeline
- Down after announcing a $100 million offering which has since been upped to $125m, We are closely monitoring to the boat again after locking in profits near the all time highs the past couple weeks
- Announced a third Oncology development candidate recently
- NGM is the type of stock we like to maintain a core number of shares in case of unexpected news that sends the stock soaring
- Announced the expansion of their portfolio with NGM707 a novel duel antagonist antibody against ILT2 and ILT4
- 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).
- 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)
- Trading down the XBI
- Released earnings 2/24/21
- $735 million in cash and equivalents, $220 million equity investment from GILD
- They expect to “expect to advance at least one new small molecule program into clinical development in the second half of 2021”
- Anticipating “Interim analysis from ARC-7,” in 2H of 2021
- GILD purchased shares at $39 as reported on 2/1/21
- Presented promising Arc 8 study data recently
- Entered a collaboration with AstraZeneca on registrational trial for domvanalimab. The stock gave up about half of those gains on Friday
- On Friday 10/15/20 RCUS President co-founder, and board member Dr. Juan Jaen filed a Form 13D (activist investor) revealing ownership of 1.5M shares
- RCUS podcast coming soon!
- Click here to listen to the latest webcasts including from two investor conferences this month
- CFO recently bought 5K shares at $21.50 (~$108K)
- Last month the CEO bought $1M worth of stock around the same price.
- Loading under $22
- Held up well at the end of the week even closing green on Friday after being down more than 5% at one point
- Very solid clinical-stage oncology company that was a big holding of one of our favorite institutional investors (The Column Group). Based on recent filings it appears the TCG reduced most of its position. We do not feel this is a bearish signal.
- In our experience, TCG likes to take activist roles in the companies they invest in. So it follows that after RCUS announced a 10-year partnership with Gilead Sciences (GILD) in May that came with a $200M equity investment by GILD, TCG decided to take its funds elsewhere (probably to NGM).
- Additionally, the partnership with GILD came with an upfront payment of $175M. Profits from therapies commercialized in the U.S will be split 50:50. Click here to read more details about the deal.
- Subsequently on 5/28 RCUS priced a $303M public offering of 11M shares priced at $27.50 (14% above the stocks closing price of $23.78 on 8/14)
- Upcoming milestones discussed in the company’s 2Q20 earnings include Phase 1a/1b safety and efficacy data being presented at ESMO in September, preliminary Phase 2 data in 4Q20 (Oct. 1st-Dec. 31st) from a study being conducted in collaboration with Genentech, preliminary data from another Phase 2 during 4Q20, and initiation of a Phase study for at least of its now discovry-stage assets in late 2020/early 2021. Since 7/31/20 the Chief Medical Officer and Chief Executive Officer have purchased shares on the open market at prices between $19.68 and $23.38. The most significant purchases being by the CEO (43,705 shares at an average price of $22.41 and total value of $979.4K)
- PT= $30+ (0-8 weeks)
Disclaimer
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.