March 8, 2023 7:49am
A sharp decline over sessions would beget a buying opportunity as Q4 and FY22 earnings are focused on dollars in 2025 runway for most reporting to date while the needy have yet to account
Pre-open Indications: 3 Positive and 2 Negative Indication
News: Mesoblast (MESO +$0.45 or +14.85; ASX: MSB) the FDA Office of Therapeutic Products (OTP) has accepted the Biologics License Application (BLA) resubmission for remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). FDA considers the resubmission to be a complete response and has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.
A daily report may say little or a lot and its final judgement may be inconclusive; yet it serves as insurance that all indications are being examined, evaluated and reported.
Subscription is coming, it’s not conscription but, an offer to join our collective of like-minded investors! Join me … in the NO spin zone.
The 8:00 a.m. edition
Remember that overnight and pre-open actions in futures don't necessarily translate into actual trading in the coming day’s session. My interpretation of the morning’s numbers is written to be informative; it’s built on will happen behind the headlines today, not tomorrow or yesterday …
Dow futures are UP +0.09% or (+31 points), S&P futures are UP +0.12% or (+4 point) and NASDAQ futures are UP +0.22% or (+24 points) early in the pre-open – so far
U.S. stock futures were barely up on Wednesday,
European markets were mixed
Asia pacific markets were mostly down and falling.
Henry’omics:
We need to understand the macro to comprehend the micro re “our” universe of cell and gene therapy companies …
Indexes felt the slap of Jerome speak before the Senate Banking, Housing and Urban Affairs Committee, as the Dow closed nearly 575 points lower and turned negative for 2023. The S&P 500 slid 1.53% to close below the key 4,000 threshold, and the Nasdaq lost 1.25%.
Economic Data Docket: Investors will get the ADP Employment Report at 8:15 a.m. ET, providing an estimate of private payrolls in February. But the ADP report has an uneven record of forecasting the Labor Department's jobs report. The February jobs report is due Friday. The JOLTS survey at 10 a.m. ET will reveal job openings as of January.
Tuesday’s (3/7) … RegMed Investors’ (RMi) closing bell: “indexes sell-off after Jerome spoke. While the cell and gene therapy sector fell as the trap door sprung "with a tightened noose on share pricing" … https://www.regmedinvestors.com/articles/12858
RegMed Investors (RMi) Research Note: Upcoming Q4 earnings reporting dates … https://www.regmedinvestors.com/articles/12830
RegMed Investors (RMi) Research Note: Q4 and FY22 earnings reporting … “The cell and gene therapy sector fluctuates in revenues, collaboration, regulatory submissions and expenses, but the changes may alarm investors who prefer to see expectation and consensus stability and share pricing growth” … https://www.regmedinvestors.com/articles/12843 17 of 35 reporting
Ebb and flow:
Q1/23 –
March – 1 positive and 4 negative close
· February – 1 holiday, 2 vacation, 7 negative and 8 positive closes
· January – 2 holidays, 11 positive and 9 negative closes
Companies in my headlights – It’s your decision; I provide ideas and context: INDICATIONS
Positive indications:
Tuesday’s closing price, aftermarket dollar ($) and cent ($0.00) value and percentage (%)
· Mesoblast (MESO) closed down -$0.19 with a positive +$0.45 or +14.85% pre-open indication on news of Resubmission of the Biologic License Application (BLA) for Remestemcel-L in children.
· Verve Therapeutics (VERV) closed down -$0.06, with a positive +$0.37 or +1.97% aftermarket indication.
· Prime Medicine (PRME) closed down -$0.37 with a positive +$0.26 or +1.69% pre-open indication.
Negative Indications:
Tuesday’s closing price, aftermarket dollar ($) and cent ($0.00) value and percentage (%)
· Beam Therapeutics (BEAM) closed down -$0.51, with a negative -$0.24 or -0.64% pre-open indication
· MiMedx (MDXG) closed down -$0.06 with a negative -$0.13 or -3.10% aftermarket indication.
· uniQure NV (QURE) closed up +$0.47 with a negative -$0.61 or -2.86% pre-open indication
The BOTTOM LINE: I try to keep it simple and short!
Investors should be cautious about new buys in the very short term and might want to reduce overall exposure somewhat.
Friday's February jobs report, as well as next week's CPI inflation report will put pressure on share pricing.
The rush of Q4 and FY22 earnings to release is on … I do NOT believe there aren't a lot of cell/gene therapy companies in position yet – UNTIL earnings (Q4 and FY22) are reported – any breakout is a false hope with the inevitable downside re-occurring.
17 of my 35 covered have reported.
I also hate to be so negative or contrarian but, this is a NO spin zone and truth is its product.
And I can always be WRONG but, mostly EARLY!
Upcoming Q4 earnings reporting will present challenges to share pricing.
· Cellectis SA (CLLS) 3/9 - Thursday
· Agenus (AGEN) 3/14 – Tuesday
· AxoGen (AXGN) 3/14 – also on Tuesday
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.
All investments are subject to risks. Investors should consider investment objectives.
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.
Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions securities referred to in this publication.
