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Monday, January 9, 2023

Ionis, Royalty in $1.1B Deal to Advance Ionis’ Genetic Medicines, Commercial Readiness

 

  • Royalty Pharma to acquire an interest in SPINRAZA® and pelacarsen royalties – Ionis retains majority of royalties and all milestones from Novartis for pelacarsen

  • Royalty Pharma to pay Ionis $500 million upfront and up to $625 million in milestones

  • Agreement enables Ionis to achieve commercial readiness for multiple late-stage programs and advance its innovative pipeline of genetic medicines

Dexcom Prelims and Outlook

 DexCom, Inc. (Nasdaq: DXCM), the leader in real-time continuous glucose monitoring ("CGM"), today reported that it expects preliminary, unaudited revenue for the fourth quarter ended December 31, 2022 to be at least $815 million, an increase of 17% over the fourth quarter of 2021 on a reported basis and 20% on an organic1 basis. U.S. revenue is expected to be approximately $606 million, representing growth of 17% over the fourth quarter of 2021. International revenue is expected to be approximately $209 million, an increase of 15% over the fourth quarter of 2021 on a reported basis and 26% on an organic1 basis.

For fiscal 2022, total preliminary, unaudited revenue is expected to be approximately $2.91 billion, an increase of 19% over 2021 on both a reported and organic basis.

For 2023, Dexcom currently anticipates total revenue of approximately $3.35 billion to $3.49 billion, representing expected growth of approximately 15% to 20% over 2022. This outlook considers sensor volume growth driven by increasing CGM awareness for people with diabetes, the launch of the Dexcom G7 CGM system in the U.S. and its continued rollout in international markets, further international expansion, and overall market dynamics.

In addition, Dexcom currently estimates 2023 Non-GAAP Gross Profit Margin and Non-GAAP Operating Margin to be at the following levels:

- Non-GAAP Gross Profit Margin of 62 – 63%

- Non-GAAP Operating Margin of approximately 16.5%

1 Excludes non-CGM revenue acquired in the trailing twelve months, as well as the impact of foreign exchange.

Fourth Quarter 2022 Financial Results Conference Call

Dexcom will report its audited full fourth quarter and fiscal 2022 financial results on Thursday, February 9, 2023 after the close of market. Management is currently scheduled to host a conference call at 4:30 p.m. (Eastern Time) that day. More details will be provided later.

https://finance.yahoo.com/news/dexcom-reports-preliminary-unaudited-revenue-130000272.html

Schrodinger in License Pact with Bristol, Otsuka

 Today Schrödinger announced several new developments, including the following:

  • Schrödinger and Bristol Myers Squibb amended their discovery, development and commercialization collaboration to include a new discovery program in neurology. Schrödinger received an additional upfront payment for the new program and is eligible to receive discovery, development and commercialization milestones, as well as royalties on net sales, similar to the terms of the original agreement.

  • Schrödinger reported a new program targeting LRRK2, a genetically validated target with therapeutic potential for the treatment of Parkinson’s disease. In 2022, Schrödinger generated cryo-electron microscopy structures of LRRK2 which is helping to accelerate the identification of novel LRRK2 inhibitors. Schrödinger expects to select a development candidate for this program in 2024.

  • Schrödinger and Otsuka Pharmaceutical Co., Ltd., a leading healthcare company in Japan, together with Otsuka’s subsidiary Astex Pharmaceuticals, announced an innovative multi-part agreement that includes a collaboration to discover molecules for an emerging CNS disease target, as well as a knowledge-transfer program and expanded licensing agreement for Schrödinger’s platform for Otsuka’s new drug discovery facility. Under the terms of the drug discovery portion of the agreement, Schrödinger will be responsible for drug design through lead optimization and Otsuka will be responsible for all other drug discovery and clinical development activities. Schrödinger received an upfront payment and will be eligible to receive discovery, development and regulatory milestones, as well as tiered royalties on net sales of any products emerging from the drug discovery collaboration in all markets.


Immunocore eyes pipeline expansion

 KIMMTRAK (tebentafusp-tebn) approved in over 30 countries with continued global expansion in 2023-2024; preliminary unaudited net sales of ~$50 million in Q4 and ~$140 million for full year 2022

Priority for IMC-F106C (PRAME HLA-A02) is enrollment in monotherapy and combination arms of Phase 1/2 clinical trialwith data planned by 1H 2024

Expanding PRAME franchise, including targeting PRAME HLA-A24 with a first-in-class ImmTAC to broaden the addressable patient population, and PRAME HLA-A02 half-life extended ImmTAC for patient convenience

https://finance.yahoo.com/news/immunocore-announces-strategic-priorities-including-120000277.html

Asensus guidance below views

 Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today provided a preliminary 2022 year-end corporate update.

Fourth Quarter Highlights

  • Over 690 procedures were performed globally during the quarter, representing growth of over 23% compared to the fourth quarter 2021

  • Five Senhance® Surgical Programs were initiated during the quarter, including two in Germany, two in Japan, and one in the CIS region

  • Fourth quarter unaudited revenue is expected to be approximately $2.2 - $2.8 million

Surgery Partners, Inc. Reaffirms 2022 Full Year Guidance

 Members of management of Surgery Partners, Inc. (NASDAQ:SGRY) ("Surgery Partners" or the "Company"), a leading short-stay surgical facility owner and operator, will be meeting with investors today, January 9, 2023, as part of the 41st Annual J.P. Morgan Healthcare Conference, including a presentation at 8:15 p.m. ET. Based on results through November 2022, the Company is re-affirming its 2022 Adjusted EBITDA guidance of $375 million to $385 million and its 2022 Revenue guidance of $2.50 billion to $2.55 billion.

https://finance.yahoo.com/news/surgery-partners-inc-reaffirms-2022-123000197.html

Twist, Astellas in Multitarget Antibody Discovery Research

 -Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, today announced a research collaboration with Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") to discover antibodies against multiple targets of interest to develop curative therapies for patients suffering from diseases that lack treatment options.

"This second collaboration with Astellas demonstrates the power of our antibody discovery capabilities. The depth and breadth of our Library of Libraries enables highly potent antibodies, often missed using other technologies, to be identified across multiple potential therapeutic areas," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We are looking forward to continuing our working relationship with Astellas and building on the progress made to date in our first collaboration."

Under the terms of the agreement, Twist will conduct antibody discovery activities against multiple targets identified by Astellas. In addition to an upfront payment and project specific research fees, Twist will be eligible to receive up to $11 million USD per product through payments associated with specific clinical and commercial milestones. Twist will also be eligible to receive royalty payments on product sales. Astellas will be responsible for the development, manufacturing and commercialization of any such products.

https://finance.yahoo.com/news/twist-bioscience-astellas-enter-multitarget-120000309.html