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MACK shareholders approve dissolution—cash distribution=$15.10/sh:
https://www.businesswire.com/news/home/20240510857372/en
The liquidating distribution stems from a $225M milestone payment MACK received from Ipsen for FDA approval of Onivyde (#msg-173845049).
MACK had been a shell company with a contingent receivable since ceasing operations almost five years ago (#msg-149704592).
FDA delays action date on MRNA’s RSV vaccine:
https://finance.yahoo.com/news/moderna-announces-investigational-rsv-vaccine-110000123.html
FDA delays action date on MRNA’s RSV vaccine:
https://finance.yahoo.com/news/moderna-announces-investigational-rsv-vaccine-110000123.html
NVAX—(+130%)—inks SNY collaboration_for COVID and COVID/flu vaccines—$500M up-front cash:
https://finance.yahoo.com/news/novavax-sanofi-announce-co-exclusive-060000896.html
SNY will commercialize NVAX’s existing COVID vaccine and will develop a combination COVID/flu vaccine incorporating NVAX’s “Matrix-M” adjuvant technology.
That info was from RVNC's CD training program.
No Daxxify therapeutics sales were booked in 1Q24. The formal Daxxify launch in cervical dystonia was announced today (#msg-174389042).
1Q24 was a weak quarter for the entire dermal-filler market. ABBV's 1Q24 Juvederm sales were -16% YoY.
MGNX—(-63%/AH)—reports multiple “Grade 5” SAEs in phase-2 trial:
https://finance.yahoo.com/news/macrogenics-provides-corporate-progress-first-200100560.html
Correction—RVNC’s 1Q24 non-GAAP operating expenses were $73.6M, consistent with the low end of the 2024 guidance range of $290-310M.
RVNC reports 1Q24 results—reiterates 2024 guidance:
https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Reports-First-Quarter-2024-Financial-Results-Provides-Corporate-Update/default.aspx
1Q24 financial highlights
• 1Q24 Daxxify sales were $22.1M, -8% QoQ — due to $2.0M of redeemed coupons and normal seasonality in the aesthetics business — and +44% YoY.
• 1Q24 Daxxify volume (units shipped) was +7% QoQ.
• 1Q24 dermal-filler sales were $29.6M, -14% QoQ and -2% YoY.
• Cash at 3/31/24 was $277.1M, a $23.2M increase relative to 12/30/23 due to $94.0M of net proceeds from the Mar 2024 public offering.
• 1Q24 non-GAAP operating expenses (excluding COGS) were $73.6M, consistent with the low end of RVNC’s full-year 2024 guidance of $290-310M.
2024 guidance
• RVNC re-iterated 2024 guidance for product revenue (Daxxify + RHA) of >=$280M.
• RVNC re-iterated 2024 guidance for non-GAAP operating expenses of $290-310M.
Note: An earlier version of this post (deleted) had a typo with respect to the 1Q24 non-GAAP operating expenses.
RVNC formally launches Daxxify for cervical dystonia:
https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Expands-into-the-U.S.-Therapeutics-Market-with-the-Launch-of-DAXXIFY-for-the-Treatment-of-Cervical-Dystonia/default.aspx
RVNC formally launches Daxxify for cervical dystonia:
https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Expands-into-the-U.S.-Therapeutics-Market-with-the-Launch-of-DAXXIFY-for-the-Treatment-of-Cervical-Dystonia/default.asp
RVNC reports 1Q24 results—reiterates 2024 guidance:
https://investors.revance.com/investors/Press-Releases/news-details/2024/Revance-Reports-First-Quarter-2024-Financial-Results-Provides-Corporate-Update/default.aspx
1Q24 financial highlights
• 1Q24 Daxxify sales were $22.1M, -8% QoQ — due to $2.0M of redeemed coupons and normal seasonality in the aesthetics business — and +44% YoY.
• 1Q24 Daxxify volume (units shipped) was +7% QoQ.
• 1Q24 dermal-filler sales were 29.6M, -14% QoQ and -2% YoY.
• Cash at 3/31/24 was $277.1M, a $23.2M increase relative to 12/30/23 due to $94.0M of net proceeds from the Mar 2024 public offering.
• 1Q24 non-GAAP operating expenses (excluding COGS) were $68.9M, slightly below the quarterly run rate for RVNC’s full-year 2024 guidance of $290-310M.
2024 guidance
• RVNC re-iterated 2024 guidance for product revenue (Daxxify + RHA) of >=$280M.
• RVNC re-iterated 2024 guidance for non-GAAP operating expenses of $290-310M.
SOLV reports pro forma 1Q24 results—reiterates 2024 guidance:
https://finance.yahoo.com/news/solventum-reports-first-quarter-2024-105000516.html
SOLV was spun out of 3M on 4/1/24, so the 1Q24 financial results are pro forma based on what SOLV would have reported if it had it been an independent company.
SOLV re-iterated 2024 guidance given on 3/19/24—see #msg-174067513. (2024 guidance includes the pro forma financials for 1Q24 and actual SOLV results for the remainder of the year.)
The only consequential update is that SOLV is not initiating a dividend, so that free cash flow can be directed toward paying down debt. This decision is not surprising in light of the large debt load SOLV took on as part of the spinoff from 3M.
p.s. No 1Q24 CC due to the Investor Day webcast just a few weeks ago.
RAPT—(-34%)—ends_clinical_programs_in atopic dermatitis and asthma:
https://finance.yahoo.com/news/rapt-therapeutics-reports-first-quarter-120000252.html
In Jan 2024, NVO restarted selling lower-dose strengths of Wegovy in the US, which had been curtailed in Jun 2023 due to supply constraints. The reintroduction of lower-dose strengths lowered the average selling price for Wegovy in 1Q24 relative to prior quarters.
CTMX—(-37%/AH)—My reading of the PR is that they had only 2 partial responses among 51 enrolled patients in all cancer types. The PR obfuscates, but it didn’t fool investors, evidently.
https://finance.yahoo.com/news/cytomx-therapeutics-announces-positive-initial-201000477.html
There is no timeline because CVM knows that the trial will never be completed.
EOLS 1Q24 CC transcript:
https://finance.yahoo.com/news/q1-2024-evolus-inc-earnings-112413236.html
Number of comments and questions about double-dose Jeuveau during EOLS 1Q24 CC today: zero.
ALGS 1Q24 results:
https://www.globenewswire.com/news-release/2024/05/07/2877224/0/en/Aligos-Therapeutics-Reports-Recent-Business-Progress-and-First-Quarter-2024-Financial-Results.html
Cash at 3/31/24 was $112.7M, down from $135.7M at 12/31/23.
No details on when a phase-2 COVID trial, with support from NIH, will start. The PR merely says, “phase-2 enabling activities…are underway.”
No CC.
EOLS reports 1Q24 results—reiterates 2024 guidance:
https://investors.evolus.com/press-releases-and-news/news-details/2024/Evolus-Reports-First-Quarter-2024-Results-and-Provides-Business-Update/default.aspx
1Q24 Jeuveau sales were $59.3M, –3% QoQ (consistent with seasonal patterns in the aesthetics business) and +42% YoY.
1Q24 GAAP loss was ($8.9M) or ($0.22)/sh.
Cash at 3/31/24 was $97.0M, an increase of $34.2M relative to 12/31/23 due to the $47.0M net proceeds from the Mar 2024 public offering.
Excluding the proceeds from the Mar 2024 public offering, 1Q24 operating cash burn was $12.8M.
2024 revenue guidance remains $255-265M, +26-31% relative to 2023.
More on MDGL’s Rezdiffra launch:
https://www.fiercepharma.com/pharma/remarkable-interest-madrigal-touts-early-launch-progress-first-mash-drug-rezdiffra-despite
Is STRL strictly an engineering company, or do they also produce raw materials?
MDGL—(-8%)—reports 1Q24 results:
https://finance.yahoo.com/news/madrigal-pharmaceuticals-reports-first-quarter-110000708.html
No revenue was booked in 1Q24 because the Rezdiffra launch occurred in April.
MDGL had $1.1B of cash at 3/31/24 thanks to the public offering immediately following FDA approval of Rezdiffra (#msg-174068028).
The stock is +6% as I'm typing. Investors like cost-cutting.
KVUE reports 1Q24 results—cuts workforce 4%:
https://investors.kenvue.com/financial-news/news-details/2024/Kenvue-Reports-First-Quarter-2024-Results/default.aspx
2024 guidance remains as follows:
• Sales growth of 1-3%
• Organic sales growth of 2-4% (with a 1% headwind from currency)
• Non-GAAP EPS of $1.10-1.20. This excludes 2024 restructuring costs related to the 4% layoff of $275M or $0.14/sh. (A similar amount of restructuring costs is expected in 2025.) If the 2024 restructuring costs were included in the non-GAAP EPS guidance, the range would be $0.96-1.06. At the midpoint of this range, the current share price ($20.05) represents a P/E ratio of about 20x.
CC slides:
https://s202.q4cdn.com/991673667/files/doc_financials/2024/q1/KVUE-Q1-2024-Earnings-Presentation_FINAL_WEBSITE.pdf
ENTA updated corporate slides (5/6/24)
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
The latest version of the slide set is almost identical to the previous version (from 3/13/24); the differences are:
• Slides 3 and 7 have updated financial info from FY2Q24 (ending 3/31/24).
• Slide 37, which shows 2024 news flow, has two small changes: 1) Data from the Zelicapavir (f/k/a EDP-938) RSVPEDs study is expected in 2H24 rather than 3Q24; and 2) Selection of a lead candidate in the CSU program is expected in 4Q24 rather than simply 2024. There is no specific guidance on the timing of topline data from the RSVHR study, which is recruiting patients in the Southern Hemisphere.
(EXAS)—FDA approves colorectal-cancer diagnostic from private company, Geneoscopy:
https://www.businesswire.com/news/home/20240506185019/en
Geneoscopy is commercializing the test in a collaboration with Labcorp.
ENTA reports FY2Q24* results—raises FY2024 expense guidance:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-39
• 3/31/24 cash = $300.3M, a decrease of $37M relative to 12/31/23.
• FY2Q24 royalty revenue was $17.1M, -10% QoQ and -4% YoY. 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
• FY2Q24 R&D expenses were $35.6M, consistent with ENTA’s updated fiscal-year guidance of $125-145M (raised from the $100-120M guidance given in Nov 2023).
• FY1Q24 SG&A expenses were $14.2M, consistent with ENTA’s updated guidance of $50-60M (raised from the $45-50M guidance given in Nov 2023). Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA says its cash and expected royalty revenue are sufficient to fund operations through the end of FY3Q27, which is one quarter earlier than the prior guidance of end of FY2027.
*ENTA’s fiscal year ends on September 30.
ENTA reports FY2Q24* results—raises FY2024 expense guidance:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-39
• 3/31/24 cash = $300.3M, a decrease of $37M relative to 12/31/23.
• FY2Q24 royalty revenue was $17.1M, -10% QoQ and -4% YoY. 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
• FY2Q24 R&D expenses were $35.6M, consistent with ENTA’s updated fiscal-year guidance of $125-145M (raised from the $100-120M guidance given in Nov 2023).
• FY1Q24 SG&A expenses were $14.2M, consistent with ENTA’s updated guidance of $50-60M (raised from the $45-50M guidance given in Nov 2023). Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA says its cash and expected royalty revenue are sufficient to fund operations through the end of FY3Q27, which is one quarter earlier than the prior guidance of end of FY2027.
*ENTA’s fiscal year ends on September 30.
I have not used Perplexity or any other AI chatbot on a regular basis.
Addendum—PFE can boost its liquidity at any time by paring its HLN stake of 2.1B ordinary shares, worth ~$9B at the current market price:
https://www.sec.gov/Archives/edgar/data/1900304/000007800324000082/hln13d-a7.htm
Note: 1 HLN ADS = 2 ordinary shares.
EYPT—(-38%)—misses phase-2 primary_endpoint_in DR:
https://www.globenewswire.com/news-release/2024/05/06/2875682/0/en/EyePoint-Pharmaceuticals-Announces-Topline-Data-from-the-Phase-2-PAVIA-Trial-of-DURAVYU-in-Non-Proliferative-Diabetic-Retinopathy.html
BNTX reports 1Q24 results—reiterates 2024 sales guidance:
https://finance.yahoo.com/news/biontech-announces-first-quarter-2024-104500069.html
2024 sales guidance remains $2.7-3.7B (€2.5-3.5B). Echoing partner PFE, BNTX says ~90% of 2024 COVID-vaccine revenue will come in 4Q24.
Cash at 3/31/24 was $18.2B, down $1.0B relative to 12/31/23.
PFE hiring suggests more M&A coming—Citi biotech_analyst_ to_head_business_development:
https://www.businesswire.com/news/home/20240506861564/en
Andrew Baum’s title will be EVP, Chief Strategy and Innovation Officer. He will report directly to PFE’s CEO.
PFE hiring suggests more M&A coming—Citi biotech_analyst_ to_head_business_development:
https://www.businesswire.com/news/home/20240506861564/en
Andrew Baum’s title will be EVP, Chief Strategy and Innovation Officer. He will report directly to PFE’s CEO.
GLYC—(-79%)—misses phase-3 primary endpoint_in AML:
https://finance.yahoo.com/news/glycomimetics-announces-results-pivotal-phase-100000750.html
See #msg-171216181 for related info.