STAAR Surgical prelims

 STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of the EVO family of Implantable Collamer® Lenses (EVO ICL) for myopia, astigmatism and presbyopia, today announced preliminary results for the fourth quarter and fiscal year ended December 29, 2023. Preliminary net sales were approximately $76.5 million for the fourth quarter and approximately $322.5 million for fiscal 2023. Operating margin is expected to be approximately 5% for the fourth quarter and fiscal 2023.

“Fiscal 2023 was a year of positive market share gains, sales growth and continued profitability for STAAR. Our teams finished the year on a strong note with global ICL sales increasing 22% in the fourth quarter including 26% growth in APAC,” said Tom Frinzi, President and CEO of STAAR Surgical. “ICL unit growth also compares particularly favorably to recent industry trends, outpacing refractive industry growth by at least 25 points for the third year in a row.2 Global ICL sales increased 18% for fiscal 2023 driven by 21% growth in APAC, 7% growth in EMEA and 10% growth in the Americas.”

Mr. Frinzi continued, “2023 was also a year of transition and fast learning as we launched new market development strategies while continuing to invest in innovation. Global voice of customer surveys, the most recent completed in November, show willingness to recommend and satisfaction with product quality and clinical outcomes continue to exceed 95%. These data bolster our confidence that utilization of our ICL technology will continue to move down the diopter curve opening up a larger portion of the vast addressable market opportunity. We anticipate clinical journals will publish two new peer-reviewed papers in the first half of 2024 that should further enhance surgeon confidence in measurement and lens size selection across the wide range of diagnostic devices and tools surgeons use to measure the eye for our lenses. Additionally, we intend to continue our investment in innovation projects such as intermediate lens sizes and AI driven tools.”

“Our sales outlook for fiscal 2024 balances the recent industry trends and challenging economic environment for consumers against our conviction that ICL will continue to capture refractive market share globally. We therefore expect our net sales for fiscal 2024 will be approximately $335 million to $340 million which contemplates above-industry rates of growth of approximately 10% for ICL sales in both China and the U.S.3 We will continue to be disciplined in our investments on the path to realizing our market opportunity and anticipate our GAAP operating margin and earnings will be at least breakeven for fiscal 2024. We are confident our actions will increasingly resonate with a growing number of surgeons and patients in both large and emerging markets globally,” concluded Mr. Frinzi.

Cash, cash equivalents and investments available for sale was approximately $230 million as of December 29, 2023, an increase of approximately $28 million from $201.7 million at September 29, 2023. Accounts receivable was approximately $90 million as of December 29, 2023.

The Company expects to report complete fourth quarter and fiscal year results on or about February 21 and provided today’s information due to investor meetings taking place this week. The financial information in this release is unaudited and subject to adjustment in the final audited financial statements to be filed with the Company’s Annual Report on Form 10-K.

https://www.businesswire.com/news/home/20240108591608/en/

Biolife prelims underwhelm

 Roderick de Greef, Chairman and CEO, commented, "As we enter the new year, our team is fully committed to operational execution that positions BioLife for sustained revenue growth and profitability. We are pleased to announce preliminary results for the fourth quarter, showing an 11% sequential increase in our core cell processing revenue which came in ahead of our expectations. In parallel, the divestiture of our freezer business continues to progress and is expected to conclude this quarter, significantly enhancing our financial profile as our high margin, recurring cell processing business grows as a percentage of total revenue post divestiture."

de Greef continued, "Looking ahead, trends exiting 2023 and early in 2024 leave us cautiously optimistic that macro and inventory headwinds are easing, and customer behavior is normalizing. Our class-defining portfolio of cell processing products are embedded in a total of 14 approved therapies, with the potential for 10 more by year-end, which uniquely positions BioLife as one of the only pure play enablers of the nascent but fast-growing cell and gene therapy market. We look forward to providing additional detail regarding our financial performance and outlook on our fourth quarter and year-end 2023 earnings call in February."

https://www.prnewswire.com/news-releases/biolife-solutions-announces-preliminary-fourth-quarter-and-full-year-2023-unaudited-revenue-302028158.html

Travere update and outlook

 Received 459 new patient start forms for FILSPARI® (sparsentan) in the fourth quarter of 2023; preliminary net product sales of FILSPARI totaled $15 million for the fourth quarter

Company on track to submit sNDA to FDA in Q1 2024 for conversion of the existing U.S. accelerated approval of FILSPARI in IgAN to full approval

CHMP opinion on potential approval of sparsentan for the treatment of IgAN in Europe expected in Q1 2024

Pivotal Phase 3 study of pegtibatinase in classical homocystinuria (HCU) underway 

https://www.globenewswire.com/news-release/2024/01/08/2805256/0/en/Travere-Therapeutics-Provides-Corporate-Update-and-2024-Outlook.html

Karyopharm prelims, objectives at JP Morgan

 Accelerating Innovation and Growth Strategy with Top-Line Data Readouts Expected in 2H 2024 and 2025 from Three Pivotal Phase 3 Studies Evaluating Selinexor in Multiple Myeloma, Endometrial Cancer and Myelofibrosis – 

– Preliminary Unaudited Full Year 2023 Total Revenue and U.S. XPOVIO® (selinexor) Net Product Revenue Expected to be Approximately $146 Million and $112 Million, Respectively, Meeting Company's Guidance –

– Potential for Selinexor to be a Novel Maintenance Treatment for Patients with TP53 Wild-Type Endometrial Cancer Further Strengthened with Long-Term Exploratory Subgroup Analyses from SIENDO Study; Recruitment Ongoing in the Company's Pivotal Phase 3 Study; Further Updates Planned to be Presented in 2024 –

– Opportunity to Define a New Myelofibrosis Treatment Paradigm Based on the Encouraging Data Presented from the Phase 1 Study of Selinexor in Combination with Ruxolitinib in Patients with Treatment-Naïve Myelofibrosis; Recruitment Ongoing in the Company's Pivotal Phase 3 Study; Further Updates Planned to be Presented in 2024 –

– Expect Cash Runway into Late 2025 Supporting Company Through Multiple Potentially Value Generating Milestones

These achievements and updates will be discussed during a webcast presentation at the 42nd Annual J.P. Morgan Healthcare Conference to be held on January 10, 2024, at 5:15 p.m. Eastern Time/2:15 p.m. Pacific Time. A live webcast of the presentation and breakout session, along with accompanying slides, can be accessed under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. An archived replay will be available for 30 days following the event. The presentation slides will also be available on the Company's website following the event.

https://www.prnewswire.com/news-releases/karyopharm-announces-preliminary-unaudited-2023-revenue-and-2024-objectives-302028197.html

Rigel update above views

 

• Preliminary fourth quarter 2023 total revenue of approximately $35.7 million which includes record TAVALISSE® net product sales of $25.7 million and REZLIDHIA® net product sales of $3.9 million
• Strategic alliance with MD Anderson to advance REZLIDHIA in AML and other cancers
• Collaboration with CONNECT to evaluate REZLIDHIA in a Phase 2 clinical trial in glioma

https://www.prnewswire.com/news-releases/rigel-pharmaceuticals-provides-business-update-302027953.html

iRhythm prelims, update at JP Morgan

 

• Grew fourth quarter 2023 patient registrations in excess of 22% compared to the fourth quarter 2022
• CAMELOT study published in the peer-reviewed American Heart Journal in December 2023, demonstrating higher clinical diagnostic yield and lower odds of retesting with Zio® long-term continuous monitoring service (LTCM) compared to other LTCM as well as to event recorder, mobile cardiac telemetry, and Holter; LTCM also associated with the lowest incremental health care cost and utilization compared to MCT, event recorder, and Holter
• Submitted 510(k) to the Food and Drug Administration (FDA) for legacy changes made via letter to file to the Zio AT system
• Received CE mark under European Union Medical Device Regulation (EU MDR) for the Zio® Monitor system and ZEUS system, enabling further global expansion and demonstrating our commitment to providing our highest quality product and services
• Closed a five-year, $150 million term loan credit facility to strengthen the Company’s capital structure and ensure ongoing financial flexibility
• Expects revenue for the full year 2024 of approximately $575 million to $585 million, representing growth of approximately 18-20% compared to the midpoint of 2023 guidance last updated in November 2023

“This past year has been truly transformative for iRhythm as we have made exceptional strides towards advancing our vision to bring innovative, trusted solutions to millions of patients,” said Quentin Blackford, iRhythm’s President and CEO. “In 2023, we accelerated momentum in both existing customer channels and new ones, initiated the largest product launch in the company’s history, released a refreshed patient mobile application to drive digital engagement, implemented enhancements like Afib burden into our Zio AT reports for our physician customers, published the CAMELOT data that showed monitoring with the Zio service is more likely to prevent retesting and get to a diagnosis, and opened our global business services center in the Philippines to continue driving operational efficiency on a global scale. I am so excited that we are rapidly approaching nearly 8 million reports posted since the company’s inception, and these important milestones are exemplary of the progress that we are driving at iRhythm to bring our platform technology to more patients worldwide.”

“Moving into 2024, we are poised to build upon this momentum while making strategic investments for future growth opportunities. In addition to strength that we continue to see from our cardiology customer segment, we continue to be excited by the tremendous opportunity that exists to reach more patients by opening the primary care channel, and we have been encouraged that approximately 21% of U.S. Zio XT and monitor volumes in 2023 came through this prescriber group. We have line of sight to milestones within multiple international markets, intend to aggressively advance our product roadmap, and will continue to drive operational efficiency and financial sustainability through an intense focus on organizational discipline. With additional capital to invest in growth and our unique offering well positioned to deliver value to patients, physicians, healthcare systems, and shareholders, we have never been more excited for the future at iRhythm," concluded Mr. Blackford.

Closing of Flexible, Non-Dilutive Senior Secured Term Loan Facility

Today the Company also announced the closing of a five-year debt facility providing up to $150 million in capital from Braidwell LP, a healthcare-focused investment firm. An initial $75 million has been funded with the option to draw an additional $75 million over the next year. The proceeds of the transaction will be used to repay the Company’s outstanding debt and for other general corporate purposes.

“As we continue to bring our Zio services to millions of patients globally and prepare for significant growth in the years to come, we are very pleased to strengthen iRhythm’s balance sheet with flexible, non-dilutive capital through our partnership with Braidwell, an existing iRhythm investor and a collaborative partner to the healthcare industry,” said Brice Bobzien, iRhythm’s Chief Financial Officer. “Since inception, iRhythm has been a pioneer in patch-based ambulatory cardiac monitoring by bringing artificial intelligence, relentless focus on the patient experience, and new models of care delivery to the digital healthcare space. This additional capital will allow us to continue pursuing this mission as we invest in technology initiatives and strategic pillars for growth.”

Webcast and Conference Presentation Information

At the upcoming 42nd Annual J.P. Morgan Healthcare Conference, iRhythm’s management is scheduled to present on Monday, January 8, 2024, at 4:30 p.m. Pacific Time/ 7:30 p.m. Eastern 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/2024/01/08/2805454/0/en/iRhythm-Technologies-Shares-Preliminary-Fourth-Quarter-2023-Highlights-and-Business-Update-at-the-42nd-Annual-J-P-Morgan-Healthcare-Conference.html

Dexcom prelims, 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, 2023 to be at least $1.030 billion, an increase of 26% over the fourth quarter of 2022. U.S. revenue is expected to be approximately $765 million, representing growth of 26% over the fourth quarter of 2022. International revenue is expected to be approximately $265 million, an increase of 27% over the fourth quarter of 2022.

For fiscal 2023, total preliminary, unaudited revenue is expected to be approximately $3.62 billion, an increase of 24% over 2022.

“Dexcom had an incredible year in 2023 with the largest expansion of coverage in our company’s history, a successful rollout of Dexcom G7 in the U.S. and expansion of G7 to more than 15 international markets, and an acceleration in our revenue growth,” said Kevin Sayer, Dexcom’s chairman, president and CEO. “We plan to continue this momentum in 2024 and further expand our addressable market with the expected launch of our first product for people who do not use insulin.”

2024 Outlook

For 2024, Dexcom currently anticipates total revenue of approximately $4.15 billion to $4.35 billion, representing expected organic growth1 of approximately 16% to 21% over 2023. This outlook considers sensor volume growth driven by increasing CGM access and awareness for people with diabetes, the introduction of Dexcom’s product for people who do not use insulin, further international expansion, and overall market dynamics.

In addition, Dexcom currently estimates 2024 Non-GAAP Gross Profit Margin and Non-GAAP Operating Margin to be at the following levels:

• Non-GAAP Gross Profit Margin of approximately 63 – 64%
• Non-GAAP Operating Margin of approximately 20%

Dexcom also announced today that Stelo, its new glucose sensor designed specifically for people with type 2 diabetes who do not use insulin, was submitted to the FDA for review in Q4 2023. Stelo will offer 15-day sensor wear, a cash-pay option and a software experience tailored specifically for non-insulin users. The system is expected to launch in the U.S. in summer 2024.

https://www.businesswire.com/news/home/20240108809977/en/