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Monday, January 13, 2025

Inspire Med prelims, outlook

 

  • Revenue for the fourth quarter of 2024 is anticipated to be in the range of $239.5 million to $239.7 million, an approximately 25% increase over the same quarter of 2023
  • Revenue for full year 2024 is anticipated to be in the range of $802.6 million to $802.8 million, an approximately 28% increase over full year 2023
  • Activated 72 new centers in the U.S. in the fourth quarter of 2024, bringing the total to 1,435 U.S. medical centers implanting Inspire therapy
  • Created 12 new sales territories in the U.S. in the fourth quarter of 2024, bringing the total to 335 U.S. sales territories
  • Initiated the soft launch of the Inspire V neurostimulator with over 40 implants completed in Singapore and the U.S.
  • Implemented a new organizational structure intended to drive continued growth

Initial Full Year 2025 Revenue Guidance

  • Revenue for full year 2025 is anticipated to be in the range of $940 million to $955 million, a 17% to 19% increase over full year 2024

Bicycle Updated Topline in Urothelial Cancer, 2025 Strategic Priorities

 Updated topline Phase 1 combination data for zelenectide pevedotin plus pembrolizumab continue to show promising anti-tumor activity and a differentiated safety profile in first-line cisplatin-ineligible metastatic urothelial cancer

NECTIN4 gene amplification development strategy underway for zelenectide pevedotin in breast cancer, lung cancer and multiple tumors, with several Phase 1/2 trials planned to start in 2025

Emerging radiopharmaceuticals pipeline progressing, with additional MT1-MMP human imaging data expected in mid-2025 and first EphA2 human imaging data planned for 2H 2025

Expected financial runway into 2H 2027 to support execution of clinical and strategic priorities

https://www.businesswire.com/news/home/20250113767062/en/

Axsome prelims

 Auvelity preliminary 4Q and full year 2024 net product sales of $92.6 million and $291.4 million, respectively

Sunosi preliminary 4Q and full year 2024 net product revenue of $25.7 million and $93.8 million, respectively

https://www.globenewswire.com/news-release/2025/01/13/3008327/33090/en/Axsome-Therapeutics-Provides-Preliminary-Fourth-Quarter-and-Full-Year-2024-Net-Revenue.html

BridgeBio at JPM: Strong Cash Position

 - Remarkable early Attruby demand: 430 scripts written by 248 unique HCPs since FDA approval with broad uptake across academic centers and community centers in all patient types

- Fully enrolled three major market Phase 3 clinical trials: FORTIFY (BBP-418 for LGMD2I/R9); CALIBRATE (encaleret for ADH1); and PROPEL 3 (infigratinib for Achondroplasia)

- Well-financed to launch Attruby and read out major market Phase 3 trials: $406M in cash as of last quarter, received $500M upon acoramidis FDA approval from royalty facility, and anticipate $105M in regulatory milestones in 1H 2025 from acoramidis Europe and Japan approvals

https://www.globenewswire.com/news-release/2025/01/13/3008704/0/en/BridgeBio-Announces-Commercial-Progress-Program-Updates-and-2025-Milestones.html

US Supreme Court rejects bid by oil companies to toss Honolulu's climate suit

 The U.S. Supreme Court declined on Monday to hear a bid by Sunoco and other oil companies to scuttle a lawsuit by Honolulu accusing them of misleading the public for decades about the dangers of climate change induced by the burning of fossils fuels.

The justices turned away an appeal by the oil companies of a decision by Hawaii's top court allowing the suit, which alleged violations of state law, to proceed. Other defendants in the lawsuit include Exxon Mobil, BP, ConocoPhillips, BHP Group, Marathon Petroleum and Chevron.

The suit was filed in 2020 by the city and county of Honolulu and the Honolulu Board of Water Supply, a semi-autonomous city agency. The plaintiffs said misleading statements made by the companies about the impact of their fossil fuel products paved the way for property and infrastructure damage caused by human-induced climate change.

The plaintiffs have sought unspecified monetary damages.

https://www.msn.com/en-us/money/companies/us-supreme-court-rejects-bid-by-oil-companies-to-toss-honolulu-s-climate-suit/ar-BB1rnm3x

Lilly asks US government to pause drug price negotiation program: report

 Eli Lilly has asked the U.S. government to pause the new law that allows Medicare to negotiate prices for its costliest prescription drugs, Bloomberg News reported on Monday, citing Lilly Chief Executive Dave Ricks.

https://www.usnews.com/news/top-news/articles/2025-01-13/lilly-asks-us-government-to-pause-drug-price-negotiation-program-bloomberg-news-reports

Pfizer going 'all in' on obesity drug development, CEO Bourla says

 U.S. drugmaker Pfizer is going "all in" to develop its experimental obesity drug and has been recruiting more experts in that area, Chief Exeuctive Officer Albert Bourla said at the JPMorgan Healthcare conference on Monday.

https://money.usnews.com/investing/news/articles/2025-01-13/pfizer-going-all-in-on-obesity-drug-development-ceo-bourla-says