May 16, 2023 4:39pm

As Federal Trade Commission (FTC) puts a damper on biotech, cell and gene therapy equities blocking Amgen (AMGN -$2.28) acquisition of Horizon Therapeutics (HZNP -$16.93)

Pre-Open Indications: 3 Hits and 2 Miss

Coverage Dropped: Avrobio (AVRO) and Verastem Oncology (VSTM) – trading under Nasdaq minimum of $1.00 for too long; added Generation Bio (GBIO) and Blueprint Medicines (BPMC)

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 - truth!  

Subscription is coming, it is not conscription but, an offer to join our collective of like-minded investors!  Join me … in the NO spin zone.

If I have learned one thing as a former research analyst in a venture and public fund, operating executive, adjunct (MBA) business school professor now a journalist; it is that your life and your portfolio are largely tied to your knowledge of price movements and questioning pricing targets.

 

The Dow closed DOWN -336.26 points (-1.01%), the S&P closed DOWN -26.41 points (-0.64%) while the Nasdaq closed DOWN -22.16 points (-0.16%)

 

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.

Indexes were mixed over debt ceiling worries.

Investors are anxiously awaiting progress on debt ceiling negotiations. The fear for investors is that the crisis isn’t resolved by June 1 and therefore puts pressure on markets that are already worried about banking turmoil, sticky inflation and the Federal reserve’s next decision on interest rates.

Economic Data Docket: April retail sales came in weaker than expected, rising 0.4% last month. That was lower than the 0.8% increase anticipated by economists.

 

Tuesday (5/15) … RegMed Investors’ (RMi) pre-open: “are we owning the unownable?” … https://www.regmedinvestors.com/articles/12961

 

Pre-Open Indications: 3 Hits <Chinook Therapeutics (KDNY -$1.05), Ionis therapeutics (IONS -$0.25), Regenxbio (RGNX -$1.99)>< and 2 Miss < bluebird bio (BLUE -$0.44), Fate Therapeutics (FATE -$0.42)  

 

RegMed/Stem/Cell and Gene Therapy’s 35 covered equities’ Advance/Decline (A/D) lines: what happened – differences …

  • Tuesday’s advance/decline line opened negative at 7 up/ 27 down and 1 flat, stayed negative with 7 up/ 27 down and 1 flat at the mid-day, ending with a negative close of 6/28 and 1 flat

 

Key Metrics:

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

  • Tuesday, the IBB was down -2.05% and the XBI was down -2.92%

The CBOE Volatility Index (VVIX: INDEX) tracked:

  • Tuesday was up +1 point or +5.84% at 18.12

 

Closing Down (10 of 28):

  • Alnylam Pharmaceuticals (ALNY -$15.23 after Monday’s +$0.84)
  • CRISPR Therapeutics (CRSP -$4.25 after Monday’s +$2.05),
  • Ultragenyx (RARE -$2.33 after Monday’s +$1.92),
  • Beam Therapeutics (BEAM -$2.13 after Monday’s +$2.66)
  • Intellia Therapeutics (NTLA -$2.06 after Monday’s +$2.43),
  • Regenxbio (RGNX -$1.99 after Monday’s +$2.38),
  • Sage Therapeutics (SAGE -$1.82 after Monday’s +$1.62),
  • uniQure NV (QURE -$1.66 after Monday’s -$0.22),
  • Blueprint Medicine (BPMC -$1.30),
  • Chinook Therapeutics (KDNY -$1.05),

Flat (1);

  • Biostage (OTCQB: BSTG)

Closing Up (6 of 6):

  • Voyager Therapeutics (VYGR +$0.97 after Monday’s -$0.04),
  • BioLife Solutions (BLFS +$0.78),
  • Mesoblast (MESO +$0.12),
  • Homology Medicine (FIXX +$0.02),
  • Solid Biosciences (SLDB +$0.01),
  • Precigen (PGEN +$0.01),

 

Q2/23 – May

  • Tuesday closed negative with 6 incliner, 28 decliners and 1 flat

 

The BOTTOM LINE: I try to keep it simple … and short!

I follow the dictum, quoting Churchill that “short words are best, and the old words when short are best of all.”

“The BIGGEST risk to the economy – the clock is ticking for a divided U.S. Congress to raise the federal government's debt ceiling, which currently stands at over $31 trillion but risks running out of cash as soon as June 1.

Federal Trade Commission (FTC) action to block Amgen-Horizon deal threatens the thesis driving biotech stocks higher.

·         Horizon shares plunged 17% at 9:34 a.m. in New York. Amgen was little changed.

·         While the agency’s scrutiny isn’t a surprise given its earlier requests, the two companies don’t significantly overlap in their product areas, said Evan Seigerman, an analyst at BMO Capital Markets. The deal was expected to close in the next couple of weeks, and a lawsuit could mark a change in how the FTC views consolidation in the drug industry, he said.

·         A suit would mark the first time in more than a decade that the FTC has sought to stop a pharmaceutical deal outright. <Bloomberg>

·         “Does this signals FTC’s view around the broader anticompetitive nature of pharmaceutical mergers,

 

As I have stated, “The cell and gene therapy sector could experience yet another the “flight of Icarus” …  since “our” universe have oscillated between gains and losses since the first of 2023!”

 

There is VALUE out there however, it’s about playing or betting the timing of the sector. Even as I had stated, “I wouldn’t be buying into this rally … I would be selling into this upside!”

What’s SAFE … “No one company is immune in the sector and this market of rolling downdrafts?”

WILL Tuesday reflect … SUSTAINABILITY of share pricing.

A very appropriate quote, “You don't do well by trying to be right; it is impossible for humans. You do well by figuring out when you're wrong faster than others do.” <Nassim Nicholas Taleb>

 

There are clear winners — and losers — at the start of May.

The top three (3) performing in the session:

·         Tuesday: Voyager Therapeutics (VYGR), BioLife Solutions (BLFS) and Mesoblast (MESO)

·         Monday: Beam Therapeutics (BEAM), Intellia Therapeutics (NTLA) and Regenxbio (RGNX)

While The worst three (3) in the session:

·         Tuesday: Alnylam Pharmaceuticals (ALNY), CRISPR Therapeutics (CRSP) and Ultragenyx (RARE)

·         Monday: bluebird bio (BLUE), uniQure NV (QURE) and MiMedx (MDXG)

 

Earnings:

RegMed Investors (RMi) Research Note: Q1/23 earnings reporting dates, net losses, cash positions and runway outcomes … https://www.regmedinvestors.com/articles/12923  -

Sector earnings season is drawing to a close …

·         One (1) net income from 34 reported to date:

 

WHY (?) do I keep posting, so investors can get a daily update of the sector's share pricing and some individual companies TRUTHS while electronic trading chews on our portfolio edges.

I am definitely considered a contrarian depending on the session – one has to be a watcher of the ups and downs as well as measurer of sentiment. I am also a NO trust investor but, a validate and verify journalist/analyst.

The NO spin zone! U.S. public shareholders deserve accountability …

Biostage (OTCQB: BSTG) …

·         Tuesday closed flat with 27 shares traded after Monday closed up +$0.32 with 326 shares traded after Friday closed down -$0.21 with 3,430 shares traded, Thursday closed FLAT with 50 shares traded, Wednesday closed up +$0.07 with 125 shares traded and last Tuesday closed down -$0.01 with 120 shares traded, <3-month average =1,478 shares>

·         Question: Review the number of shares traded … is OTCQB: BSTG a Ponzi scheme (with their pump/promote buy and sell agenda) as shares are bought to replace those sold?

·         Biostage (OTCQB: BSTG) issued a 10-Q (late Friday), reporting a Q1/23 net loss of -$2.89 M or -$0.24 per share with a cash position of $3,369 M and a runway until Q4/2023:

·         Accumulated deficit:  $85,901 M – still NO product in sight!

 

My question that resounds, that should be asked is how many companies are at the end of sentiments …  leash?

 

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.