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Monday, January 8, 2024

Treace prelims, outlook, at JP Morgan

 Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced its preliminary, unaudited fourth quarter and full-year 2023 revenue results.

Highlights:

  • Preliminary revenue of $61.8 million to $62.2 million in the fourth quarter of 2023, an approximate 25% increase at the midpoint over the same period in 2022.

  • Preliminary revenue of $186.7 million to $187.1 million for the full-year 2023, an approximate increase of 32% at the midpoint compared to the prior year and above the high end of the previously provided revenue guidance range of $182 million to $186 million.

  • Preliminary blended average revenue per Lapiplasty® procedure kit sold in the fourth quarter of 2023 was approximately $6,437, a record high and 9% increase over the same period in 2022.

  • Substantial new active surgeon additions of approximately 164 in the fourth quarter of 2023 and approximately 468 for full-year 2023; Ended the year with approximately 2,855 active surgeons, a 20% increase compared to the prior year and approximately 29% of the estimated 10,000 U.S. surgeons performing bunion surgery.

  • Ended the fourth quarter of 2023 with 227 direct quota carrying sales representatives, a 35% increase over year-end 2022 and 82% revenue contribution in the fourth quarter of 2023.

“We delivered another year of significant progress in 2023 and expect to remain on track to drive strong growth and profitably scale our business in the years ahead,” said John T. Treace, CEO, Founder and Board Member of Treace. “We believe we are driving a market conversion in a large, underserved market as the fastest-growing, publicly-traded company in foot and ankle with differentiated bunion, midfoot, and related complementary technologies. We also believe we are in a great position strategically with an expanding addressable market opportunity with new technologies, such as our Adductoplasty®, Hammertoe and SpeedPlate™ products, and more innovations to come, supported by differentiating clinical studies, continued strong additions to our surgeon base and a powerful, focused commercial organization. We look forward to aggressively pursuing these significant opportunities to drive the performance of the business and believe we have all the elements in place to deliver strong growth and sustained market penetration in 2024 and beyond.”

2024 Outlook

Treace plans to provide 2024 financial guidance during its fourth quarter 2023 earnings conference call, which is currently scheduled for Tuesday, February 27, 2024 at 4:30 p.m. Eastern Time.

The preliminary unaudited financial information in this press release has not been subject to the more rigorous standards of review for Treace’s filed financial statements, may be adjusted, including as a result of its internal closing processes and the external auditing procedures of its independent registered public accounting firm, and remains subject to change until the Company files its full financial statements for 2023.

Treace to Present at J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024

John T. Treace, CEO, Founder and Board Member of Treace, will present at the J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024 at 3:45 pm Pacific Time / 6:45 pm Eastern Time. Following this presentation, Mr. Treace will be joined by Mark Hair, CFO of Treace, for a question-and-answer session. A live webcast of this event, as well as an archived recording and presentation, will be available in the Investors section of Treace’s website at https://investors.treace.com/news-events/events-presentations.

https://finance.yahoo.com/news/treace-announces-preliminary-unaudited-fourth-120000447.html

Sarepta prelims

Preliminary total net product revenue is expected to total $1.145 billion for full-year 2023

– Preliminary ELEVIDYS net product revenue is expected to be $131.3 million for the fourth quarter and $200.4 million for full-year 2023, significantly exceeding consensus

– Preliminary RNA-based PMO net product revenue for the fourth quarter and full-year of 2023 are expected to total $234.3 million and $945.0 million, respectively, exceeding 2023 full-year guidance of $925 million

– Preliminary year-end 2023 cash, cash equivalents, restricted cash and investments balance of approximately $1.7 billion

https://www.businesswire.com/news/home/20240108854944/en/

GeneDx expects to exceed revised 2023 revenue guidance

 Sees fourth quarter 2023 revenue from continuing operations1 of more than $57M with at least 63% year-over-year revenue growth for exome and genome test revenue

Reduced fourth quarter 2023 cash burn 51% year-over-year and 21% sequentially

Ending December 31, 2023 cash position of at least $131 million

Reiterating the path to profitability in 2025

https://www.globenewswire.com/news-release/2024/01/08/2805483/0/en/GeneDx-Announces-Preliminary-2023-Financial-Results.html

Avadel Strong LUMRYZ Launch Performance and Prelims

-- Approximately $19 million and $28 million of net revenue from sales of LUMRYZ™ estimated for the fourth quarter and full year 2023, respectively --

-- Generated continued robust demand for LUMRYZ with greater than 1,900 patients enrolled in RYZUPTM and more than 1,000 patients initiating therapy through December 31 --

-- Signed Emisar (Optum Rx GPO) contract, all 3 PBM owned GPO contracts now finalized for 2024 --

-- Supplemental New Drug Application (sNDA) for LUMRYZ in the pediatric narcolepsy population accepted by FDA; approval decision expected in September 2024 --

https://www.globenewswire.com/news-release/2024/01/08/2805288/0/en/Avadel-Pharmaceuticals-Announces-Strong-LUMRYZ-Launch-Performance-and-Provides-Preliminary-Fourth-Quarter-and-Full-Year-2023-Financial-Highlights.html

iTeos 2024 Strategic Priorities and Anticipated Milestones

  TIGIT program clinical data readouts anticipated in 2024, including two Phase 2 trials assessing belrestotug + dostarlimab in 1L NSCLC and 1L HNSCC

- Adenosine portfolio clinical data readouts anticipated in second half of 2024, including inupadenant’s Phase 2 A2A-005 and EOS-984’s Phase 1 trial

- EOS-984 preclinical data demonstrating novel mechanism of action in the adenosine pathway anticipated in second quarter of 2024

- Cash balance and investment balance of $644.9 million as of September 30, 2023 expected to provide runway through 2026

https://www.globenewswire.com/news-release/2024/01/08/2805279/0/en/iTeos-Announces-2024-Strategic-Priorities-and-Anticipated-Milestones.html

Regeneron preliminary Q4 US sales of Eylea below expectations

 Regeneron Pharmaceuticals on Monday reported eye drug Eylea's fourth-quarter preliminary U.S. sales below Wall Street expectations, as the company's blockbuster product faced pressure from a rival.

The company garnered $1.46 billion from Eylea drug sales, in comparison to consensus Wall Street estimates of $1.53 billion as pegged by Wells Fargo analyst Mohit Bansal last week.

Shares of Regeneron were down over 2% in premarket trading.

Eylea, jointly developed with Bayer AG, has driven Regeneron's earnings for years, but sales have now come under pressure, partly from Roche's Vabysmo that secured U.S. approval in 2022.

Regeneron has set its hopes on a higher-dose version of Eylea. U.S. sales of the version came in at about $123 million in the quarter, the company said.

Wall Street expectations pegged sales of high-dose Eylea at $129 million, according to the consensus estimates compiled by Well Fargo.

The higher dose version, which has 8mg compared to the regular dose of 2mg, got U.S. approval in August for treatment of a disease that is a leading cause of blindness among the elderly .

The regular dose of Eylea could also face further pressure from possible entry of biosimilar drugs, as Regeneron's claims in a key patent litigation against Mylan, now part of Viatris , were upheld last month, and Wells Fargo said it expects biosimilar competition from 2026-27.

https://finance.yahoo.com/news/2-regeneron-preliminary-q4-us-130448375.html

China Issues National Standards for Automotive Chips

 China's industry ministry on Monday issued plans for a set of national standards for semiconductors used in the automotive sector.

China will formulate more than 30 key automotive chip standards by 2025 and more than 70 related standards by 2030, the Ministry of Industry and Information Technology (MIIT) said in a statement.

https://www.usnews.com/news/technology/articles/2024-01-08/china-issues-national-standards-for-automotive-chips