Guardant prelims

 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced preliminary, unaudited results for the quarter and full year ended December 31, 2024.

Fourth quarter 2024 preliminary unaudited financial results

For the three-month period ended December 31, 2024, as compared to the same period of 2023:

• Total revenue of approximately $200 million, an increase of 29%
• Reported approximately 57,300 oncology clinical tests (excluding Shield) and approximately 11,050 biopharma tests, an increase of 24% and 16%, respectively
• Reported approximately 6,400 Shield screening tests, with revenue of approximately $4 million

Full year 2024 preliminary unaudited financial results

For the twelve-month period ended December 31, 2024, as compared to the same period of 2023:

• Total revenue of approximately $737 million, an increase of 31%
• Reported approximately 206,700 oncology clinical tests (excluding Shield) and approximately 40,500 biopharma tests, an increase of 20% and 35%, respectively

Preliminary unaudited free cash flow was approximately negative $84 million for the fourth quarter of 2024, and approximately negative $275 million for the full year 2024. Cash, cash equivalents, restricted cash and marketable debt securities were $944 million as of December 31, 2024.

“2024 was an outstanding year for Guardant. We delivered key milestones across the portfolio and completed the upgrade of Guardant360 LDT onto our Smart Liquid Biopsy platform. We finished the year strong with preliminary full year revenue growth of 31%, driven by strong clinical and biopharma revenue and increasing Guardant360 ASPs. Looking ahead, we believe we are well positioned to continue to drive growth in our oncology business,” said Helmy Eltoukhy, co-founder and co-CEO.

“We are extremely pleased with the strong traction and support we saw in the first full quarter of commercial launch of Shield. Given this success, we are focused on rapidly growing our commercial infrastructure to capture the massive opportunity ahead. We look forward to achieving additional milestones in 2025 as we continue driving innovation and growth in our screening business,” said AmirAli Talasaz, co-founder and co-CEO.

Guardant Health has not completed preparation of its financial statements for the fourth quarter or full year of 2024. The revenue, test volumes and free cash flow presented in this release for the fourth quarter and the year ended December 31, 2024, are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results. The company is in the process of completing its customary year-end close and review procedures as of and for the year ended December 31, 2024, and there can be no assurance that final results for this period will not differ from these estimates. During the preparation of Guardant Health’s consolidated financial statements and related notes as of and for the year ended December 31, 2024, the company’s independent registered public accountants may identify items that could cause final reported results to be materially different from the preliminary financial estimates presented herein.

Upcoming events

Guardant Health plans to report its fourth quarter and full year audited financial results for the period ended December 31, 2024, during its February 2025 earnings call.

https://www.businesswire.com/news/home/20250113396781/en/

iRhythm prelims at JPM

 

• Anticipate full year 2024 revenue slightly above high end of previously stated guidance range of $587.5 million provided in October 2024
• Record quarter of new account openings for both Zio monitor and Zio AT during the fourth quarter 2024 as well as strong volume contributions from large national accounts
• Launched first four health care systems on Epic Aura during the fourth quarter 2024 with broad commercial roll out for Epic health systems across the U.S. beginning in 2025
• Initiated Zio monitor shipments for home enrollment patients during the fourth quarter 2024
• Five studies presented at the American Heart Association highlight Zio Monitor’s high patient satisfaction, engagement and compliance with the patient MyZio app and digital tools, health economic impact of early arrhythmia detection in type 2 diabetes and respiratory disease, and AI insights on sleep and activity patterns1
• Expect revenue for the full year 2025 of approximately $675 million to $685 million

“This past year was a period of significant growth and transformation for iRhythm,” said Quentin Blackford, iRhythm’s President and CEO. “In our core U.S. business, we achieved a record number of Zio registrations from across different channels – serving over 2 million patients, advancing Zio utilization earlier in the patient care pathway, and growing our market penetration within ambulatory cardiac monitoring. Notably, we secured FDA clearance for two 510(k) submissions related to our Zio AT device, further advancing our technology for the benefit of patients, physicians, and healthcare systems who rely on our Zio AT services. To enable future growth on a global scale, we also expanded into four European countries, earned Japanese regulatory approval, signed a strategic technology licensing agreement with BioIntelliSense, and launched the initial phase of manufacturing automation for Zio monitor. Lastly, we implemented several sustainable operational efficiencies throughout the business, driving profitability expansion and positioning us to continue to grow efficiently into the future.”

“With this strong foundation of execution in 2024, we are well positioned to continue transforming iRhythm through a commitment to excellence, innovation, and value creation,” Blackford continued. “In 2025, our top priority will be on ensuring that our quality systems are best-in-class. Commercially, we plan to expand further into primary care channels through our land-and-expand strategy and by continuing to drive momentum within risk-bearing entities as Zio becomes a key tool in population health management. Internationally, we are also excited to drive further penetration within international markets where we are earlier in the commercial adoption curve. With our recent achievements and the opportunities ahead, we remain focused on delivering sustainable value for patients, clinicians, healthcare systems, and shareholders,” concluded Mr. Blackford.

Webcast and Conference Presentation Information
At the upcoming 43rd Annual J.P. Morgan Healthcare Conference, iRhythm’s management is scheduled to present on Monday, January 13, 2025, at 7:30 p.m. Eastern Time/4:30 p.m. Pacific Time. Interested parties may access a live and archived webcast of the presentation on the “Events & Presentations” section of the company’s investor website at investors.irhythmtech.com.

https://www.globenewswire.com/news-release/2025/01/13/3008541/0/en/iRhythm-Technologies-Shares-Preliminary-Fourth-Quarter-2024-Highlights-and-Business-Update-at-the-43rd-Annual-J-P-Morgan-Healthcare-Conference.html

Nevro Prelims

 Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced its preliminary, unaudited fourth-quarter and full-year 2024 revenue and other financial results.

Preliminary, Unaudited Financial Highlights

• Fourth-quarter 2024 worldwide revenue is expected to be approximately $105 million to $106 million, representing a decrease of 9% to 10% on a reported and constant currency basis compared with the fourth quarter of 2023; fourth-quarter 2024 U.S. revenue is expected to be approximately $91 million to $92 million, representing a decrease of 9% to 10% compared with the fourth quarter of 2023.
• Full-year 2024 worldwide revenue is expected to be approximately $408 million to $409 million, representing a year-over-year decrease of approximately 4% on a reported and constant currency basis compared with the full-year 2023; full-year 2024 U.S. revenue is expected to be approximately $352.5 million to $353.5 million, or an approximately 4% decrease compared with full-year 2023. Full-year 2024 worldwide revenue is higher than the guidance the company provided in November 2024 primarily due to the impact of greater-than-anticipated spinal cord stimulation (SCS) device replacement procedures in the fourth quarter of 2024.
• Cash, cash equivalents and short-term investments are expected to total approximately $292.5 million as of December 31, 2024, an increase of approximately $15.5 million from September 30, 2024.

"We are pleased that our full-year 2024 worldwide revenue is coming in ahead of our expectations," said Kevin Thornal, Nevro's CEO and president. "Also, as we previously communicated, we reallocated investments to our direct-to-consumer (DTC) advertising efforts in the third quarter of 2024, and we continue to see patient interest and response as a result. We anticipate that the benefit from our DTC advertising will ramp throughout 2025, with a more meaningful impact in the second half of the year. Importantly, our balance sheet remains strong, reflecting our continued focus on working capital management and the benefits from our 2024 restructurings."

The company expects to report its fourth-quarter and full-year 2024 financial results and provide full-year 2025 guidance on its fourth-quarter 2024 earnings call in early March 2025.

Strategic Review Process

As previously announced, Nevro remains in ongoing discussions as it continues to explore strategic options to accelerate its growth, diversify its product portfolio and deliver shareholder value. The company will not provide any further comment or update on this process at this time.

https://www.prnewswire.com/news-releases/nevro-announces-preliminary-fourth-quarter-and-full-year-2024-revenue-results-302348849.html

IQVIA and NVIDIA Collaborate to Transform Healthcare, Life Sciences Via Advanced Agentic AI

 -IQVIA (NYSE:IQV), a leading global provider of clinical research services, commercial insights, and healthcare intelligence, today announced a strategic collaboration with NVIDIA to help realize the potential of AI in healthcare and life sciences.

The healthcare and life sciences industries generate vast amounts of data, representing significant potential for AI-powered solutions. This collaboration between IQVIA and NVIDIA will help accelerate IQVIA Healthcare-grade AI™, enabling new levels of agentic automation of complex and time-consuming workflows across the therapeutic life cycle with the precision, scalability, and trust required by IQVIA’s customers. IQVIA has been leading in the responsible use of AI, ensuring that its AI-powered capabilities are grounded in privacy, regulatory compliance, and patient safety. IQVIA Healthcare-grade AI™ represents the company’s commitment to these principles.

The collaboration will combine IQVIA’s unparalleled information assets, analytics, and domain expertise, known as IQVIA Connected Intelligence™, with the NVIDIA AI Foundry service to help transform life science processes from R&D through commercialization. This work is poised to create new efficiencies, enable new operating models, and ultimately improve patient outcomes.

https://www.businesswire.com/news/home/20250113713508/en

Illumina and NVIDIA collaborate to decode biology and propel precision health

 Illumina, Inc. (NASDAQ: ILMN), a global leader in genomic sequencing and analysis, today announced it is collaborating with NVIDIA to advance technology platforms for the analysis and interpretation of multiomic data, accelerating progress in clinical research, genomics AI development, and drug discovery.

To optimize analysis of the vast amounts of data involved in multiomic research, Illumina and NVIDIA will combine advancements in AI with multiomic data at scale. Leveraging Illumina's leading sequencing technology and informatics tools alongside NVIDIA's leading AI technology, the partnership aims to accelerate drug discovery and clinical development, delivering powerful tools to help pharmaceutical companies identify new and better drug targets.

Illumina's leading sequencing technology—as well as its menu of DRAGEN-powered multiomics offerings, genomics AI tools, and Illumina Connected Analytics platform—has streamlined genomic data generation and analysis. Illumina has invested in AI for genomic interpretation, developing the leading SpliceAI, PrimateAI-3D, and Emedgene xAI algorithms.

Now, in addition to its own efforts, Illumina will look to expand its customer offerings with models developed by the NVIDIA Biology Foundation Model Research Team and partners. Customers will also be able to leverage these models with their own proprietary datasets to improve the performance for biologically relevant tasks of interest, such as cell state or gene transcription prediction.

With this new partnership, the global R&D community can tap into rich genomic data by integrating NVIDIA RAPIDS™ accelerated data science software with the NVIDIA BioNeMo™ platform's generative AI models and fine-tuning capabilities for proprietary datasets, as well as MONAI for spatial cell imaging workflows. Illumina and NVIDIA will work to make these tools accessible on the Illumina Connected Analytics platform.

https://www.prnewswire.com/news-releases/illumina-and-nvidia-collaborate-to-decode-biology-and-propel-precision-health-302348920.html

AbCellera Expands Collaboration with AbbVie to Develop Novel T-Cell Engagers for Oncology

 AbCellera (Nasdaq: ABCL) announced today that it has expanded its existing collaboration with AbbVie Inc. (NYSE: ABBV) to include the discovery of T-cell engagers (TCE) in oncology. The expansion builds upon the successful partnership established in December 2022 and includes access to AbCellera’s TCE platform to develop therapeutic antibodies for tumor targets.

“We are pleased to broaden our AbbVie collaboration and look forward to using AbCellera’s TCE platform to bring novel cancer immunotherapies to patients in need,” said Carl Hansen, Ph.D., founder and CEO of AbCellera.

Under the terms of the agreement, AbCellera will lead discovery activities and AbbVie has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera will receive upfront and research payments and is eligible to receive downstream milestone payments as well as tiered royalty payments on net sales.

https://www.businesswire.com/news/home/20250113347375/en/

Lilly to acquire Scorpion Therapeutics' mutant-selective PI3Kα inhibitor program

 The acquisition will expand Lilly's oncology pipeline with STX-478, the differentiated and potentially best-in-class, mutant-selective PI3Kα inhibitor currently in a Phase 1/2 clinical trial

STX-478 could potentially address 30-40% of people with hormone-positive breast cancer, building on Lilly's advancements against this disease

 Eli Lilly and Company (NYSE: LLY) and Scorpion Therapeutics, Inc. ("Scorpion"), a private biotechnology company developing small molecule precision oncology therapies, today announced a definitive agreement for Lilly to acquire Scorpion's PI3Kα inhibitor program STX-478. STX-478 is a once-daily oral, mutant-selective PI3Kα inhibitor currently being evaluated in a Phase 1/2 clinical trial for breast cancer and other advanced solid tumors.  

STX-478 could represent the next generation of PI3Kα targeting agents by selectively targeting the pathway in cancerous but not healthy cells, thus overcoming a key limitation of currently available medicines that target the PI3Kα pathway. This approach could potentially offer better disease control through deeper pathway inhibition, as well as improved tolerability.

"PI3Kα mutations occur in a meaningful proportion of hormone-positive breast cancers, and there is significant unmet need for new treatment options that effectively and safely target this pathway," said Jacob Van Naarden, executive vice president and president of Lilly Oncology. "The selectivity profile of STX-478 has led to a differentiated clinical profile, enabling use in combinations with standard-of-care therapies to potentially deliver meaningful impact in earlier treatment settings when there is the best opportunity to improve outcomes for patients. We look forward to leveraging the great work of the Scorpion team to date, along with Lilly's deep expertise in breast cancer, to further advance STX-478 with speed and focus."

Under the terms of the agreement, Lilly will acquire Scorpion and Scorpion shareholders could receive up to $2.5 billion in cash, inclusive of an upfront payment and subsequent payments upon achievement of certain regulatory and sales milestones. Additionally, as part of the transaction, Scorpion will spin out a new entity to hold its employees and non-PI3Kα pipeline assets. The new, independent company would be owned by Scorpion's current shareholders with Lilly holding a minority equity interest. The new company will be led by Dr. Friedman and members of the current Scorpion management team and will focus on discovering and delivering a portfolio of precision medicines to patients, accelerated by Scorpion's discovery capabilities and non-PI3Kα pipeline of medicines.

https://www.prnewswire.com/news-releases/lilly-to-acquire-scorpion-therapeutics-mutant-selective-pi3k-inhibitor-program-302349242.html