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B-I has_a fusion protein_for NASH that_hits GLP-1/FGF21:
https://www.genengnews.com/news/boehringer-ingelheim-yuhan-launch-up-to-870m-nash-collaboration/
Could be an alternative to combination therapy.
Addendum—This program is very early, but if the MoA works it would rid hepatocytes of HBV cccDNA and thereby cure the disease.
The 1Q24 GAAP loss of $67M includes a $177M mostly-non-cash writedown from idling the Weirton, Ohio plant. This is shown in the GAAP-to-non-GAAP earnings reconciliation table at the bottom of the press release.
Private company attacking HBV via CRISPR-based editing_of_viral_DNA:
https://www.globenewswire.com/news-release/2024/04/22/2867238/0/en/Excision-BioTherapeutics-Announces-Oral-Presentation-Highlighting-Positive-Data-from-its-HBV-Program-EBT-107-at-the-Upcoming-ASGCT-2024-Annual-Meeting.html
ABEO—(-53%/AH)—receives CRL due to CMC issues:
https://finance.yahoo.com/news/abeona-therapeutics-provides-regulatory-pz-200500676.html
CLF reports 1Q24 results—authorizes new $1.5B buyback—reiterates 2024 guidance:
https://www.clevelandcliffs.com/investors/news-events/press-releases/detail/635/cleveland-cliffs-reports-first-quarter-2024-results-and
In 1Q24, CLF repurchased $608M of stock at an average price of $20, reducing shares outstanding by 6% and exhausting the pre-existing $1.0B buyback authorization. As a result, CLF has now authorized a new $1.5B buyback.
1Q24 highlights
• Revenue of $5.2B, -2% YoY
• Steel shipments of 3.94M net tons, -3% YoY
• Adjusted EBITDA of $414M, +70% YoY and +48% QoQ
• 3/31/24 net debt of ~$3.6B, up from $2.9B @12/31/23 (the increase is due primarily to the $608M share buyback)
Re-iterated 2024 guidance
• Steel shipment volumes of 16.5 million net tons, compared to 16.4 million net tons in 2023
• Steel unit cost reductions of approximately $30 per net ton, corresponding to ~$500M adjusted EBITDA benefit compared to 2023
• Capital expenditures of $675 to $725 million
The stock is down slightly in AH trading. CC Tuesday at 8:30am ET.
CLF reports 1Q24 results—authorizes new $1.5B buyback—reiterates 2024 guidance:
https://www.clevelandcliffs.com/investors/news-events/press-releases/detail/635/cleveland-cliffs-reports-first-quarter-2024-results-and
In 1Q24, CLF repurchased $608M of stock at an average price of $20, reducing shares outstanding by 6% and exhausting the pre-existing $1.0B buyback authorization. As a result, CLF has now authorized a new $1.5B buyback.
1Q24 highlights
• Revenue of $5.2B, -2% YoY
• Steel shipments of 3.94M net tons, -3% YoY
• Adjusted EBITDA of $414M, +70% YoY and +48% QoQ
• 3/31/24 net debt of ~$3.6B, up from $2.9B @12/31/23 (the increase is due primarily to the $608M share buyback)
Re-iterated 2024 guidance
• Steel shipment volumes of 16.5 million net tons, compared to 16.4 million net tons in 2023
• Steel unit cost reductions of approximately $30 per net ton, corresponding to ~$500M adjusted EBITDA benefit compared to 2023
• Capital expenditures of $675 to $725 million
The stock is down slightly in AH trading. CC Tuesday at 8:30am ET.
IMMNOV.ST—(+36%)—also_has liquid-biopsy for pancreatic cancer:
https://www.prnewswire.com/news-releases/immunovia-announces-positive-results-from-the-model-development-study-for-its-next-generation-pancreatic-cancer-detection-test-302123066.html
VAXX -37%/AH on voluntary delisting:
https://finance.yahoo.com/news/vaxxinity-announces-intention-voluntarily-delist-202700884.html
Ideal PR for a Friday evening, LOL.
HEPA terminates NASH trial:
https://www.globenewswire.com/news-release/2024/04/19/2866379/0/en/Hepion-Pharmaceuticals-Initiates-Wind-Down-Activities-in-Phase-2b-ASCEND-NASH-Trial.html
I'm going out on a limb and calling this biotech company a scam. $HEPA https://t.co/1EhBQEue5C
— Roy Friedman (@DewDiligence) January 29, 2020
Drug/biotech companies have_qualms_about chatbot security risk:
https://www.fiercepharma.com/marketing/two-thirds-top-20-pharmas-have-banned-chatgpt-and-many-life-sci-call-ai-overrated-survey
Right! ENTA updated the guidance for RSVHR reporting on the Leerink webcast on 3/13/24 (the same date as the “new” corporate slide set). The prior “it depends” guidance was from ENTA’s FY1Q24 CC on 2/7/24.
In any event, the salient point is that ENTA is not due to report any clinical data until July at the earliest. This should reassure anyone who may have thought the recent share-price decline was due to a data leak.
That makes sense (eom).
Article behind paywall. Can you post an excerpt? TIA
What did PACB gain by "hiding" the revenue problem for one quarter?
Re: Double-dose Jeuveau
Thanks for the correction. However, the fact that EOLS published the double-dose Jeuveau data in a little known journal doesn’t change my contention that the dataset has been doctored.
Jeuveau is simply a Korean knockoff of Botox, and there is no mechanistic explanation for why it ought to have a longer duration than Botox or other Botox knockoffs. Reducing the relative amount of diluent, which EOLS did the double-dose Jeuveau study, is something that Botox injectors have experimented with for decades without being able to show a material benefit in duration.
Moreover, doubling the amount of active toxin administered to a fixed region of the face would be expected to produce a higher rate of ptosis, which EOLS’ dataset did not show—a red flag that something is amiss.
IF EOLS’ double-dose Jeuveau data were real, it would be a big breakthrough that would comprise the cornerstone of EOLS’ go-to-market strategy. Instead, EOLS treats the double-dose data as an afterthought and acknowledges that few of its customers will want it.
All told, it’s pretty obvious to me that double-dose Jeuveau is a ploy that EOLS engaged not to further its own business, but rather to create confusion in the marketplace about Daxxify and thereby impede Daxxify’s commercial uptake. On this score alone, EOLS may have been successful in accomplishing what it hoped to accomplish, but the impeding of Daxxify’s uptake will be transient. A year from now, nobody will be talking about double-dose Jeuveau.
Nothing has changed regarding double-dose Jeuveau since the post I'm replying to; it remains a gimmick that has little consequence in the marketplace.
Reply to 'iwfal' on Biotech Values board:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174265867
In other words, EOLS declined to publish what they said they would, which is consistent with what I posited in #msg-173201637.
I stand by everything I said in the above-linked post. To re-iterate: Double-dose Jeuveau is a gimmick; it won't move the needle for Jeuveau to any material degree.
ENTA corporate slide set (3/13/24):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
There are no differences between the 3/13/24 slide set and the previous slide set on 2/7/24.
Clinical newsflow reiteration: ENTA expects to report data from the Zelicapavir RSVPEDs trial and the EDP-938 “challenge” trial in 3Q24. ENTA has not yet commented on when it will report data from the Zelicapavir PSVHR trial (for high-risk adults) because that depends on whether enrollment is completed during the current RSV season in the Northern Hemisphere.
GE Vernova—(ticker: GEV)—GE’s power spinoff, is a thematic investment for this board:
https://www.wsj.com/business/energy-oil/general-electrics-power-spinoff-could-be-formidable-once-fully-charged-0bd15005
VIR adds two luminaries to BoD:
https://www.businesswire.com/news/home/20240418098064/en
The capsule bios in the PR speak for themselves.
VIR adds two luminaries to BoD:
https://www.businesswire.com/news/home/20240418098064/en
The capsule bios in the PR speak for themselves.
CERE—(being acquired by ABBV)—reports phase-3 Parkinson’s data:
https://www.globenewswire.com/news-release/2024/04/18/2865216/0/en/Cerevel-Therapeutics-Announces-Positive-Topline-Results-for-Tavapadon-in-Phase-3-Adjunctive-Trial-for-People-Living-with-Parkinson-s-Disease.html
23andMe probably getting acquired by CEO/founder, Anne Wojcicki:
https://www.globenewswire.com/news-release/2024/04/18/2865332/0/en/23andMe-announces-CEO-s-intention-to-pursue-a-potential-take-private.html
https://www.sec.gov/Archives/edgar/data/1804591/000134100424000072/sc13da1.htm
CVX—US ends importation of Venezuela oil—sanctions reimposed:
https://finance.yahoo.com/news/us-reimpose-venezuela-oil-ban-142402038.html
Thanks, Doc (eom).
It's not a chicken-and-egg question, IMO. After we see the full dataset, we can form reasonable suppositions as to whether Zepbound has a direct effect on OCA, or merely an indirect one. For the direct effect to have credibility, there has to be a plausible MoA (i.e. something other than weight loss).
Good news/bad news for GSK’s Shingrix:
https://www.gsk.com/en-gb/media/press-releases/new-long-term-data-show-shingrix-continues-to-provide-high-protection-against-shingles-in-adults-aged-50-and-over-for-more-than-a-decade/#
Shingrix’s protection is longer lasting than most people expected. Corollary: It’s unlikely that patients will need booster shots (beyond the initial two-dose regimen).
LLY’s Zepbound—>statsig clinical benefit_in sleep-apnea phase-3 trials:
https://www.fiercepharma.com/pharma/eli-lillys-tirzepatide-scores-again-time-2-sleep-apnea-trials
VNDA implements poison pill in response to unsolicited takeover proposal:
https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-adopts-limited-duration-stockholder-rights-plan-302119627.html
PACB—Slow payment by customers would boost the Accounts receivable line, but it wouldn’t reduce revenue (unless some of the payments were deemed unrecoverable). There must be another explanation for the revenue flatlining.
ABT 1Q24 results and guidance:
#msg-174255199 1Q24 results/2024 guidance
#msg-174255202 Sales/growth by business segment
ABT reports 1Q24 results—raises 2024 guidance slightly—stock sells off because ABT didn’t raise 2024 guidance to a larger degree:
https://abbott.mediaroom.com/2024-04-17-Abbott-Reports-First-Quarter-2024-Results-and-Raises-Midpoint-of-Full-Year-Guidance-Ranges
2024 guidance for organic sales growth excluding COVID diagnostics is now 8.5-10%, up from the prior guidance of 8-10%.
2024 guidance for non-GAAP EPS (which excludes FX and restructuring costs) is now $4.55-$4.70, up from the prior guidance of $4.50-4.70.
1Q24 non-GAAP and GAAP EPS were $0.98 and $0.70, respectively, versus $1.03 and $0.59 in 1Q23. The YoY decline in non-GAAP EPS was due to lower sales of COVID diagnostics, which were $204M in 1Q24 vs $730M in 1Q23.
4Q23 FreeStyle Libre sales were $1.5B, +23% YoY in constant currency. FreeStyle Libre is the largest-selling medical device, ever, from any company.
Please see #msg-174255202 for a breakdown of ABT’s 1Q24 sales by business segment.
ABT 1Q24 Results by Business Segment
61% of overall corporate sales were ex-US.
%Corp YoY Growth
Segment Sales (const currency)
Medical devices* 45% +14%
Diagnostics 22% -16%†
Nutrition 21% +8%
Pharmaceuticals‡ 12% +14%
ABT reports 1Q24 results—raises 2024 guidance slightly—stock sells off because ABT didn’t raise 2024 guidance to a larger degree:
https://abbott.mediaroom.com/2024-04-17-Abbott-Reports-First-Quarter-2024-Results-and-Raises-Midpoint-of-Full-Year-Guidance-Ranges
2024 guidance for organic sales growth excluding COVID diagnostics is now 8.5-10%, up from the prior guidance of 8-10%.
2024 guidance for non-GAAP EPS (which excludes FX and restructuring costs) is now $4.55-$4.70, up from the prior guidance of $4.50-4.70.
1Q24 non-GAAP and GAAP EPS were $0.98 and $0.70, respectively, versus $1.03 and $0.59 in 1Q23. The YoY decline in non-GAAP EPS was due to lower sales of COVID diagnostics, which were $204M in 1Q24 vs $730M in 1Q23.
4Q23 FreeStyle Libre sales were $1.5B, +23% YoY in constant currency. FreeStyle Libre is the largest-selling medical device, ever, from any company.
Please see #msg-174255202 for a breakdown of ABT’s 1Q24 sales by business segment.
PACB—(-44%)—pre-announces flat 1Q24 revenue:
https://www.prnewswire.com/news-releases/pacbio-announces-preliminary-first-quarter-2024-revenue-and-updates-2024-revenue-guidance-302117738.html
Those are ancillary data on retreatment intervals from the ASPEN-1 and ASPEN–OLS trials. Worth knowing, but not market-moving.
The new IR firm (#msg-174240308) should be able to answer any question that Jessica could.
RVNC IR is_now_handled_by Gilmartin Group, which has an impressive client list:
https://gilmartinir.com/clients/clients-overview/
The clients are listed in alphabetical order; scan down to see the full list. To see only the biotech clients, click on the “Biotechnology” tab.