Alphatec prelims, outlook

 

• Full-year 2024 total revenue grew 27% to approximately $611 million
• Expect full-year 2025 total revenue of $732 million and positive free cash flow

Cash balance as of December 31, 2024, approximated $139 million, an increase of $58 million compared to third quarter 2024, inclusive of $50 million in proceeds related to the term loan expansion announced with the Company’s third quarter 2024 financial results.

“Our dedication to revolutionizing spine surgery fueled another year of sector-leading growth and an inflection to profitability in 2024,” said Pat Miles, Chairman and Chief Executive Officer. “As we look to what is ahead, we know our best is yet to come. ATEC is uniquely applying 100% spine focus and industry-leading knowhow to avail more predictable, more durable spine care. That is generating distinction-driven demand with powerful momentum and the highly differentiated informatics integrated into ATEC approaches will sustain our competitive edge. We’re exceptionally well positioned to self-fund the strategy that will further our success.”

The preliminary revenue results announced today are based on the Company’s current expectations and may be adjusted as a result of, among other things, completion of customary annual audit procedures.

Financial Outlook for the Full-Year 2025

The Company anticipates full-year 2025 total revenue of $732 million, reflecting growth of approximately 20% compared to the full-year 2024. This includes surgical revenue of approximately $657 million and approximately $75 million of EOS revenue. The Company also expects adjusted EBITDA of approximately $75 million, which will contribute to positive free cash flow for the full-year 2025.

The Company will report fourth quarter and full-year 2024 financial results on February 26, 2025, after the market close. The Company will host a live webcast that day at 1:30 p.m. PT / 4:30 p.m. ET.

Webcast

To access the live webcast or a replay of the webcast, please visit the Investor Relations Section of ATEC’s Corporate Website.

Dial-in

To dial into the live webcast, please register at this link. Access details will be shared via email.

https://www.businesswire.com/news/home/20250113674305/en/

ARS prelims, 2025 objectives

 Preliminary fourth quarter neffy® net product revenue of approximately $6.5 million

Preliminary cash, cash equivalents and short-term investments of $314.0 million at year-end 2024 to support an operating runway of at least three years

Company to present at 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 at 7:30am PT

• Product revenue: Preliminary neffy net product revenue for the fourth quarter of 2024 was approximately $6.5 million, with total net product sales for 2024 of approximately $7.1 million since neffy became available to wholesalers and pharmacies on September 23, 2024. More than 14,500 neffy two-pack units were delivered in the fourth quarter of 2024, including more than 1,500 units in the last week of 2024.
• Cash position: Cash, cash equivalents and short-term investments were approximately $314.0 million as of December 31, 2024. ARS Pharma reiterates its guidance that the company expects its cash, cash equivalents and short-term investments to be sufficient to fund its current operating plan for at least three years.

2025 Key Strategic Priorities for Accelerating neffy U.S. Sales and Recent Highlights

• Increase demand and traction among target prescribers, with continued sales force and medical science liaison engagement, expansion of the company’s neffy Experience Program, and rollout of additional continuing medical education (CME) programs
  • More than 3,000 healthcare providers have prescribed neffy to date, of which 80 percent are in the highest decile categories for prescribing epinephrine
  • More than 1,750 healthcare providers have participated in the neffy Experience Program
• Expand commercial access of neffy
  • Express Scripts, the second largest pharmacy benefits manager in the U.S., added neffy to its commercial national formularies in November 2024
  • On track for more than 60 percent commercial coverage by the end of the first quarter of 2025, and more than 80 percent commercial coverage by the end of the third quarter of 2025
  • Contracting consistent with target long-term total gross-to-net revenue of 50 percent
• Increase consumer awareness of neffy and availability of a needle-free option
  • Preparations are underway to launch a branded neffy direct-to-consumer marketing campaign beginning in May 2025
  • Designed to build momentum ahead of the ‘back-to-school’ season, the campaign will extend throughout the summer, driving brand recognition and encouraging patients to request neffy by name
  • In parallel, to amplify public awareness of the needle-free epinephrine option, Food Allergy Research and Education (FARE) is set to launch a public service announcement campaign featuring a celebrity ambassador with ARS Pharma support later this year
• Obtain approval of neffy 1 mg for children who weigh 15 to 30 kg
  • The sNDA filed with the U.S. FDA for neffy for children who weigh 15 to 30 kg has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025
  • Based on review timelines and subject to approval, product availability of neffy 1 mg is expected in the second quarter of 2025

Presentation at the 43rd Annual J.P. Morgan Healthcare Conference
On Wednesday, January 15, 2025, at 7:30am PT, Richard Lowenthal, President and CEO of ARS Pharma, will present a company overview at the 43rd Annual J.P. Morgan Healthcare Conference. A live webcast of the presentation and Q&A session can be accessed here or by visiting the investors section of the company’s website at www.ir.ars-pharma.com.

https://www.globenewswire.com/news-release/2025/01/13/3008466/0/en/ARS-Pharmaceuticals-Announces-Preliminary-Fourth-Quarter-2024-Financial-Results-and-2025-Objectives-for-neffy-epinephrine-nasal-spray.html

Cosmos Distribution Agreement with Virax for Avian Flu PCR Kits in Parts of EU, Mideast

  Cosmos Health Inc. ("Cosmos Health" or the "Company") (NASDAQ:COSM), a diversified, vertically integrated global healthcare group engaged in innovative R&D, owner of proprietary pharmaceutical and nutraceutical brands, manufacturer and distributor of healthcare products, and operator of a telehealth platform, announced today that it has entered into a distribution agreement with Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax") to distribute Virax-branded Avian Influenza Virus ("AIV") Real-Time PCR Kits across various major European markets and certain Gulf Cooperation Council (GCC) countries.

Specifically, Cosmos Health gains exclusive rights to distribute these kits in Greece and Cyprus, as well as non-exclusive rights in select European countries, including France, Portugal, Spain, The Netherlands, Belgium, Sweden, Finland, Denmark, Norway, Germany, Switzerland, and Austria. The agreement also grants non-exclusive distribution rights in certain Gulf Cooperation Council (GCC) countries, namely Oman and Bahrain.

These specialized RT-PCR tests reliably detect ribonucleic acid (RNA) from AIV, including the H5, H7, and H9 subtypes, such as the globally concerning H5N1 strain. By enabling healthcare professionals to quickly identify infections, the kits play a crucial role in screening individuals exposed to infected livestock or high-risk environments, supporting effective public health responses.

Under the agreement, Cosmos Health is authorized to import, sell, and distribute ViraxClear-branded kits within the agreed territories, while Virax will oversee regulatory compliance and provide the necessary documentation to support product registration and approval in these regions.

https://www.accesswire.com/967556/cosmos-health-secures-exclusive-distribution-agreement-with-virax-biolabs-for-avian-influenza-virus-pcr-kits-in-greece-and-cyprus-with-additional-rights-in-select-european-and-gcc-countries

Apyx Medical Prelims

 

• Total revenue expected to be in a range of approximately $14.1 to $14.3 million, representing a decrease of 4% to 3% year-over-year.
  • Advanced Energy revenue expected to be in a range of approximately $12.0 to $12.2 million, which is relatively flat year-over-year.
  • OEM revenue expected to be approximately $2.1 million, representing a decrease of 17% year-over-year.
    

Preliminary Full Year 2024 Revenue Summary:

• Total revenue expected to be in a range of approximately $48.0 to $48.2 million, representing a decrease of 8% year-over-year.
  • Advanced Energy revenue expected to be in a range of approximately $38.5 to $38.7 million, representing a decrease of 11% year-over-year.
  • OEM revenue expected to be approximately $9.5 million, representing growth of 6% year-over-year.
    

Management Comments:

“We are pleased with our financial performance in the fourth quarter of 2024, as we delivered over 25% sales growth in our Advanced Energy segment on quarter-over-quarter basis, and exceeded expectations,” said Charlie Goodwin, President and Chief Executive Officer. “In the back half of the year, we saw improved U.S. capital sales characterized by a doubling of generator unit sales versus the first half of 2024 and strong U.S. single use handpiece sales. We are excited to build interest in our new AYON™ Body Contouring System, which we expect to launch in the second half of 2025 pending FDA clearance. AYON positions us as a leader in surgical aesthetics and enables us to capitalize on improving market dynamics, particularly with the increase in demand for treatments to address loose and lax skin, due in part to GLP-1 drugs resulting in significant patient weight loss. We look forward to strengthening our partnership with surgeons and providing them a better tool to treat these patients.”

https://www.globenewswire.com/news-release/2025/01/13/3008454/0/en/Apyx-Medical-Corporation-Reports-Preliminary-Fourth-Quarter-and-Full-Year-2024-Revenue-Results.html

Novartis Entresto® US patent upheld by US Court of Appeals

 Novartis is pleased with the decision by the US Court of Appeals for the Federal Circuit (CAFC) that affirms the validity of the Entresto® (sacubitril/valsartan) combination patent.

We will work to appropriately enforce the combination patent through its pediatric exclusivity period expiring in July 2025. We will also continue to defend and protect all our important intellectual property and regulatory rights relating to Entresto.

There are currently no generic versions of Entresto available in the US..

https://finance.yahoo.com/news/novartis-entresto-us-patent-upheld-061500101.html

Analysts expect LA fires to be treated as single event as insured loss estimate rises to $25bn

 Analysts at Evercore ISI have estimated that insurance industry losses from the Los Angeles wildfires will be in the $20 billion to $25 billion range, and also expect the fires to be treated as one event which could help primary carriers reach their reinsurance coverage.

The fires continued to burn and spread over the weekend, and as of Saturday afternoon UK time, it was reported that the largest of the fires, the Palisades Fire, had destroyed 5,300 structures, while the Eaton Fire had damaged or destroyed more than 7,000 structures.

It’s likely that these figures have since increased, and media reports suggest that the fires across parts of southern California have now damaged or destroyed more than 12,000 structures. Further, with strong Santa Ana winds expected to return, peaking around Tuesday, the fire weather forecast is not ideal for containment for the next few days.

“While the situation is fluid, we think the insured losses will be in the $20b-25b range, with potential for it to move higher if the fires continue to spread uncontained,” say analysts at Evercore ISI.

Evercore analysts see this event as manageable for the insurers in their universe, and also expect losses to reinsurers to be minimal, but go on to say that they expect the fires to be treated as one event, which could help carriers reach reinsurance protection.

“Many reinsurance clauses on brush fires have both an hour and distance clause, which is typically 168 – 240 hours and a radius of 150 miles. Our quick distance check shows the Palisades and Eaton fires are ~25 miles apart, and began within 2 days of one another so fit within both clauses that allow them to be treated as one event,” explain analysts.

Last week, Mercury General Corporation said that it expects the fires to exceed its reinsurance retention level of $150 million, based on a preliminary assessment.

The Evercore insured loss range of up to $25 billion is the highest so far, but as the fires continue to burn, analysts at BMO Capital Markets have also updated their estimate from an initial low single-digit billion dollar loss, which they reported soon after the event, to a roughly $20 billion insured loss estimate. At this level, BMO also expects reinsurance coverages to be hit for certain insurance companies, highlighting Chubb, Allstate, Cincinnati Financial, and The Hartford as carriers expected to benefit from recoveries under their respective occurrence reinsurance programs.

Another insured loss estimate has come from Jon Schneyer, a research director at CoreLogic, who is reported to have said that a “$20 billion to $30 billion insured loss event is now on the table.”

Analysts at Jefferies have also commented on the potential insurance industry loss from the LA wildfires, noting that although preliminary estimates are in the $10 billion to $20 billion range, they expect losses to be at the higher end given how little of the fires is contained.

Interestingly, Jefferies analysts also commented on the single or multiple events question.

“Reinsurance treaties typically have hours and radius clauses. A typical hours clause would group a same peril occurring over a 7-10 day period as one. Radius restrictions would often group same perils occurring within a 250-mile radius. While these are typical terms, there is room for variance. We do not believe that it is possible to determine which contracts group the fires into one event and which would not, but we would expect the majority of reinsured exposure to be lumped into a single event,” say analysts.

Reinsurance broker Gallagher Re said recently that it expects total aggregated losses from the LA wildfires to notably exceed $10 billion, and there are other estimates also out there that suggest an ultimate insurance and reinsurance market loss nearer $30 billion is possible, especially if the fires continue to spread and can’t be controlled.

https://www.reinsurancene.ws/analysts-expect-la-fires-to-be-treated-as-single-event-as-insured-loss-estimate-rises-to-25bn/

Astrazeneca Datopotamab deruxtecan granted Priority Review for NSCLC

 Application based on TROPION-Lung05 trial and supported by data from TROPION-Lung01 and TROPION-PanTumor01 trials

Approval would mark the first for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan in lung cancer

AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.

https://www.businesswire.com/news/home/20250113048530/en/