March 5, 2024 5:16pm

A "white swan" event is a foreseeable occurrence that significantly affects the economy or financial markets. This contrasts with a "black swan" occurrence, which is unanticipated and hard to forecast. Risks …some may be predictable, and others are not predictable at all – but all have the capability of bringing a market and a sector down to its knees.

Pre-open Indications: 5 Hits and 0 Miss

News: Roche Holdings AG (ROG.SW +$1.15) and partner Alnylam Pharmaceuticals (ALNY -$0.36) experimental drug against high blood pressure was shown to work when used in combination with the standard of care in a p2 trial. <continued below>

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A 360-degree review of the who, why, when and what happened in the sector as the market and economics surround your portfolio defense. The Bottom Line includes earnings and “whispers”!

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I write this blog/newsletter to inform investors with facts and supporting numbers focused on what they need to hear that others will not say or write about – facts in evidence! 

 

Tuesday: The Dow closed DOWN -404.64 points or -1.04%, the S&P closed DOWN -52.30 points -1.02% while the Nasdaq closed DOWN -267.92 points or -1.65%

 

Henry’omics:

We need to more than consider the economic environment - rising rates and inflation to comprehend the micro re “our” universe of cell and gene therapy companies …

Tuesday’s losses come as the market cell and gene therapy equities retreated …

Indexes got whacked as steep declines in major tech names dragged the broader market further from record highs recently reached.

Despite the losses in the past two sessions, the three major averages are solidly higher year to date.

 

From title (continued): Full results of the P2 KARDIA-2 trial, testing the twice-a-year injection zilebesiran, would be presented at the American College of Cardiology Annual Scientific Session in Atlanta on April 6, Roche said in a statement on Tuesday. (Reporting by Ludwig Burger Editing by Madeline Chambers) In July last year, Roche agreed to develop and commercialize ALNY’s zilebesiran to treat hypertension, the leading cause of cardiovascular disease worldwide. ROG>SW at the time paid ALNY $310 million upfront, with milestone payments lifting the potential deal value to up to $2.8 billion in a large bet that it can address demand beyond existing cheap generic blood pressure drugs.

 

Pre-open Indication: 5 Hit < BioLife Solutions (BLFS -$1.13), CRISPR Therapeutics (CRSP -$0.75), Voyager Therapeutics (VYGR -$0.54), Blueprint Medicine (BPMC -$1.13), Regenxbio (RGNX +$3.25)> 0 MISS <

 

52-week low:

  • uniQure NV (QURE) at $5.04

 

Monday’s RegMed Investors’ (RMi) opening bell: “while fishing in the sea of portfolio equities, reel-in your nets. You will always need to cull the catch.” … https://www.regmedinvestors.com/articles/13354

 

Advance/Decline (A/D) Line:

  • Tuesday’s advance/decline line at the open was negative with 5 incliner, 28 decliners and 2 flats; ending with a negative close of 5 incliners, 29 decliners and 1 flat

 

Ebb and flow of MY covered sector cell and gene therapy session daily “endings”:

Q1/24: March, 1 positive and 2 negative closes

  • February, 1 holiday, 9 negative and 11 positive closes
  • January: 2 holiday, 12 negative and 8 positive closes

 

Key Metrics:

The iShares NASDAQ Biotechnology (IBB) and the SPDR S&P ETF (XBI) indicators:

  • Tuesday, the IBB was down -0.84% and the XBI was down -1.29%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was up +0.95 point or +7.04% at 14.44

 

Tuesday’s Closing Down (10 of 29):

  • Intellia Therapeutics (NTLA -$2.14),
  • Ultragenyx Pharmaceuticals (RARE -$1.84),
  • AxoGen (AXGN -$ after Monday’s -$1.60),
  • Blueprint Medicine (BPMC -$1.13 after Monday’s -$4.32),
  • BioLife Solutions (BLFS -$1.13 after Monday’s +$0.18),
  • Editas Medicine (EDIT -$0.78 after Monday’s -$0.61),
  • CRISPR Therapeutics (CRSP -$0.75 after Monday’s -$2.01),
  • Prime Medicine (PRME -$0.71 after Monday’s +$0.03),
  • Verve Therapeutics (VERV -$0.70 after Monday’s -$0.45),
  • Ionis Pharmaceuticals (IONS -$0.68 after Monday’s -$0.59),

Flat (1):

  • Bellicum Pharmaceuticals (BLCM) 

Tuesday’s Closing Up (5 of 5):

  • Regenxbio (RGNX +$3.25 after Monday’s +$0.17)
  • Beam Therapeutics (BEAM +$0.27 after Monday’s -$1.60),
  • Generation Bio (GBIO +$0.10 after Monday’s +$0.14),
  • Harvard Apparatus RT (OTCQB: HRGN +$0.09 after Monday’s -$0.69),
  • Sangamo Therapeutics (SGMO +$0.01)

 

Q1/24 – March

  • Tuesday closed negative with 5 incliners, 29 decliners and 1 flat1

 

The BOTTOM LINE: Indexes closed sharply lower on Tuesday as any and all types of investors eyed upcoming economic data and central bank actions.

 

Quote that hits the spot, "This seems to be a day when bad news is bad news," said Tom Hainlin, national investment strategist at U.S. Bank Wealth Management in Minneapolis. "We had sluggish data. It's more about concerns about a slowing economy, and less about how many times the Fed will cut interest rates this year." <Reuters>

 

The cell and gene therapy sector closed today down after Monday’s negative close and Friday’s closed positive …

Earnings, net losses, and per-share losses, runways and guidance have begun Q4 and FY23 which WILL be crucial to continue downside force in the sector as history has taught us i.e., investors.

 

I have seen 4 net income for the Q4 and FY23 - MiMedx (MDXG) and Voyager Therapeutics (VYGR) followed by Q4 CRISPR Therapeutics (CRSP) and Beam Therapeutics (BEAM) <but each had a FY23 loss>

20 of my covered 35 companies have reported …

Today – AxoGen (AXGN): Q4/23 net loss of -$3.9 M or -$0.09 per share with a FY23 net loss of -$21.8 M or -$0.57 per share; a cash position of $37 m and a runway untill 2027 <revenue projection of $177 M  or $181 M for FY24>

RegMed Investors (RMi) - Q4/23 & FY23 Cell and Gene Therapy Earnings Scorecard Results https://www.regmedinvestors.com/articles/11628

 

Today’s quote, ““The taller they grow, the harder they fall,” said Scott Ladner, CIO at Horizon Investments, of struggling tech stocks. “What’s going on today, internally, is the stuff that has been winning all year long is the stuff that’s getting sold.” <CNBC>

 

 I ALSO reiterate, “Don't chase the cell and gene therapy sector, especially with the Nasdaq extended.”

Short and non-sweet: SELL into STRENGTH – accumulate some “powder” i.e., cash!

  • Should have taken MY own advice yesterday!!!

 

The top three (3) performing in the session:

  • Tuesday: Regenxbio (RGNX), Beam Therapeutics (BEAM) and Generation Bio (GBIO)
  • Monday: Voyager therapeutics (VYGR), BioLife Solutions (BLFS) and Regenxbio (RGNX)

The worst three (3) in the session:  

  • Tuesday: Intellia Therapeutics (NTLA), Ultragenyx Pharmaceuticals (RARE) and AxoGen (AXGN)
  • Monday: CRISPR Therapeutics (CRSP), Blueprint Medicine (BLMC) and Alnylam Pharmaceuticals (ALNY)

Welcome to my world of defining the “grey’ in our universe!

  • Right up front, “I also hate to be so negative or contrarian but, this is a NO spin zone and facts are its product; I can always be WRONG but … I am mostly EARLY!”

 

Opinions expressed are those of the author and are subject to change, and not intended to be a forecast of future events, a guarantee of future results, nor investment advice. Whether information or intelligence is good, bad, or somewhere in between; I put into context what is relevant and useful for investors.  All investments are subject to risks. Investors should consider investment objectives.

Henry McCusker, the editor, and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication. Regulation Analyst Certification (Reg AC): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities.

I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.