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FDA approves PFE’s Beqvez gene-therapy for hemophilia-B:
https://www.businesswire.com/news/home/20240425269649/en
The US list price of $3.5M is the same as CSL’s Hemgenix (#msg-170520619).
p.s. Benveq should not be confused with PFE's Marstacimab for hemophilia A and hemophilia B (#msg-172016370), which is an antibody, not a gene therapy.
ABBV reports 1Q24 results—raises 2024 guidance:
https://news.abbvie.com/2024-04-26-AbbVie-Reports-First-Quarter-2024-Financial-Results
New 2024 non-GAAP EPS guidance $11.13-11.33, up from the prior guidance of $11.05-11.25 three months ago. The new guidance includes an ($0.08) hit from IPR&D occurring in 1Q24, which was not in the prior full-year 2024 guidance.
The midpoint of the new range ($11.23) represents 1% YoY growth from the actual $11.11 in 2023. The lack of robust YoY growth is due, in large part, to the continued uptake of Humira biosimilars in the US market and to flat Botox sales as ABBV loses some market share.
1Q24 Botox sales by indications and geography: #msg-174309306.
1Q24 worldwide Botox sales=$1.381B, -7% QoQ*, flat YoY
https://news.abbvie.com/2024-04-26-AbbVie-Reports-First-Quarter-2024-Financial-Results
• US therapeutic: $611M (-6% QoQ, +4% YoY)
• US cosmetic: $389M (-14% QoQ*, -5% YoY)
--
US total: $1.00B (61% therapeutic; 39% cosmetic) was 72% of worldwide total
• Ex-US therapeutic: $137M (+8% QoQ, +5% YoY)
• Ex-US cosmetic: $244M (-8% QoQ*, -3% YoY)
--
Ex-US total: $381M (36% therapeutic; 64% cosmetic) was 28z% of worldwide total.
*Botulinum-toxin sales for cosmetic indications are seasonally stronger during the second and fourth calendar quarters than the first and third calendar quarters.
ABBV reports 1Q24 results—raises 2024 guidance:
https://news.abbvie.com/2024-04-26-AbbVie-Reports-First-Quarter-2024-Financial-Results
New 2024 non-GAAP EPS guidance $11.13-11.33, up from the prior guidance of $11.05-11.25 three months ago. The new guidance includes an ($0.08) hit from IPR&D occurring in 1Q24, which was not in the prior full-year 2024 guidance.
The midpoint of the new range ($11.23) represents 1% YoY growth from the actual $11.11 in 2023. The lack of robust YoY growth is due, in large part, to the continued uptake of Humira biosimilars in the US market.
Stellantis.
Lourenco plays hardball, LOL.
UPS and FedEx vans are among the worst polluters. (Do their vehicles ever get engine tune-ups?) If these companies actually convert to EVs, it will be a major quality-of-life upgrade for anyone who takes walks in residential areas.
This unorthodox anti-obesity candidate may not warrant inclusion in your table, but here it is anyhow:
https://www.globenewswire.com/news-release/2024/04/25/2869629/0/en/Aphaia-Pharma-Provides-Enrollment-and-Protocol-Update-for-Phase-2-Trial-in-Individuals-with-Obesity.html
https://www.clinicaltrials.gov/study/NCT05385978
Aphaia Pharma is private.
Thanks, dewo—much appreciated!
Keytruda sold_at_a $28B(!) annualized_rate_in 1Q24, +24% YoY in_constant_currency:
https://www.businesswire.com/news/home/20240425889273/en
It’s going to be tough for MRK to replace this revenue when Keytruda goes off-patent in 2028, although a subcutaneous formulation of Keytruda could blunt some of the erosion.
Private company developing AMD tri-specific that_hits VEGF-A/VEGF-C/Ang-2:
https://www.prnewswire.com/news-releases/revopsis-secures-16-5-million-seed-funding-to-advance-first-in-class-tri-specific-therapy-for-neovascular-amd-treatment-302127081.html
Addendum re non-GAAP vs GAAP EPS:
Excluding restructuring costs from non-GAAP EPS is a policy that disapprove of because multinational, multifaceted businesses such as CAT have restructuring costs continually. In 1Q24, however, non-GAAP EPS came in slightly lower than GAAP EPS due to the exclusion from non-GAAP EPS of a one-time tax benefit.
CAT reports 1Q24 results—shares_slide_on_soft 2Q24 guidance:
PR:
https://www.caterpillar.com/content/dam/caterpillarDotCom/releases/1q24/1q24-caterpillar-inc-financial-results.pdf
CC slides:
https://s25.q4cdn.com/358376879/files/doc_financials/2024/q1/1Q-2024-Analyst-Slide-Deck_Final-1.pdf
1Q24 sales were $15.8B, flat YoY, with price increases offsetting lower volume. Sales in the Construction and Resources Industries (mining equipment) segments were -5% and -7% YoY, respectively, while sales in the Energy & Transportation segment were +7% YoY. The E&T segment comprised 45% of CAT’s product sales in 1Q24.
1Q24 non-GAAP EPS was $5.60, up from $4.91 in 1Q23. 1Q24 GAAP EPS was $5.75 up/down from $3.74 in 1Q23.
(Excluding restructuring costs from non-GAAP EPS is a policy that disapprove of because multinational, multifaceted businesses such as CAT have restructuring costs continually. In 1Q24, however, non-GAAP EPS came in slightly lower than GAAP EPS due to the exclusion from non-GAAP EPS of a one-time tax benefit.)
CAT does not provide specific guidance for sales or EPS, but it expects full-year 2024 sales to be similar to 2023. However, CAT guided to lower 2Q24 sales compared to 2Q23 (see slide #17), and this is apparently what caused today’s rather sharp selloff.
CAT reports 1Q24 results—shares_slide_on_soft 2Q24 guidance:
https://www.caterpillar.com/content/dam/caterpillarDotCom/releases/1q24/1q24-caterpillar-inc-financial-results.pdf
1Q24 sales were $15.8B, flat YoY, with price increases offsetting lower volume. Sales in the Construction and Resources Industries (mining equipment) segments were -5% and -7% YoY, respectively, while sales in the Energy & Transportation segment were +7% YoY. The E&T segment comprised 45% of CAT’s product sales in 1Q24.
1Q24 non-GAAP EPS was $5.60, up from $4.91 in 1Q23. 1Q24 GAAP EPS was $5.75 up/down from $3.74 in 1Q23.
CAT does not provide specific guidance for sales or EPS, but it expects full-year 2024 sales to be similar to 2023. However, CAT guided to lower 2Q24 sales compared to 2Q23 (see slide #17), and this is apparently what caused today’s rather sharp selloff.
The short answer to your questions is yes, but “phase-2 and “phase-2b” are not precisely defined terms—i.e. the devil is in the details.
Henry Kissinger?
For some reason, I never appreciated it until now.
I checked Jim’s X account (@JamesEKrause), and the last time he posted about VKTX was Jun 2023.
More on the same topic:
https://www.wsj.com/livecoverage/stock-market-today-earnings-04-23-2024/card/cleveland-cliffs-counting-on-biden-to-block-u-s-steel-purchase-hUHIUr7P15Rnk93TyUjB
p.s. Today's CLF CC was another one for the ages. It didn't help the share price, but it was great entertainment as well as educational.
I would argue that the two MoAs are more different than similar. Excision Bio’s approach of editing the cccDNA does not rely on the immune system—or on any host response whatsoever.
Yes, in due course. But investors' knee-jerk reaction was negative insofar as more buybacks means more debt (all else being equal).
CLF 1Q24 CC notes re capital allocation:
CLF’s targeted debt leverage is <=2.5x EBITDA. There is ample room for CLF to continue to repurchase shares while staying well below the 2.5x ceiling.
CLF has no debt maturities until 2027.
CLF 1Q24 CC transcript:
https://finance.yahoo.com/news/cleveland-cliffs-clf-q1-2024-170011838.html
Much discussion of the non-takeover of US Steel.
Caution: this transcript has several OCR-generated errors. E.g., the transcript says “gold” in several places where the actual word is GOS (Grain-Oriented [electrical] Steel).
CLF 1Q24 CC transcript:
https://finance.yahoo.com/news/cleveland-cliffs-clf-q1-2024-170011838.html
Much discussion of the non-takeover of US Steel.
Caution: this transcript has several OCR-generated errors. E.g., the transcript says “gold” in several places where the actual word is GOS (Grain-Oriented [electrical] Steel).
CLF 1Q24 CC notes re capital allocation:
CLF’s targeted debt leverage is <=2.5x EBITDA. There is ample room for CLF to continue to repurchase shares while staying well below the 2.5x ceiling.
CLF has no debt maturities until 2027.
Irony? Denmark’s national healthcare system does not reimburse for Wegovy.
Are you planning to tune in?