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DexCom(DXCM) - 2025 Q4 - Annual Results
2026-01-12 12:30
Financial Reporting - Dexcom will report preliminary, unaudited financial results for Q4 2025 and fiscal year 2025 on January 12, 2026[5]. - The preliminary results will include revenue growth rates and total revenue guidance for fiscal 2026[6]. - Dexcom's management will provide Non-GAAP Gross Profit Margin and Non-GAAP Operating Margin guidance for fiscal years 2025 and 2026[6]. - The financial results and outlook will be finalized in connection with the preparation of Dexcom's Annual Report on Form 10-K for the year ended December 31, 2025[6]. Business Updates - A business update press release was issued on January 7, 2026, providing additional context for the upcoming financial results[7]. - Dexcom's CEO, Jake Leach, will present the financial results at the J.P. Morgan 44th Annual Healthcare Conference[5]. Regulatory Compliance - The company is not classified as an emerging growth company under the Securities Act[3]. - Dexcom's financial statements and exhibits will be included in the filings as per the requirements of the Securities Exchange Act of 1934[9]. - The report will not be deemed "filed" for purposes of the Exchange Act, and the information is not incorporated by reference in any future filings[8]. Forward-Looking Statements - The company emphasizes that forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially[6].
EDAP TMS(EDAP) - 2025 Q4 - Annual Results
2026-01-12 12:30
Prostate Cancer Statistics - 3.3 million American men are living with prostate cancer, with 313,780 new cases diagnosed in the U.S. annually [7] - The global market for prostate cancer treatment includes 1.5 million new cases per year, with Europe accounting for 473,011 cases and Asia for 386,424 cases [8] HIFU Treatment Insights - The annual procedure opportunity for Focal One HIFU in prostate cancer is estimated at 470,000, with Europe contributing 165,000 and Asia 130,000 [10] - HIFU demonstrates a 90% cancer control rate compared to 86% for radical prostatectomy, indicating superior functional outcomes [18] - A multicentric study shows that HIFU has equivalent 10-year survival rates compared to external beam radiation therapy (EBRT), with lower mortality rates [20] Financial Performance - Revenue for the three months ended September 30, 2025, was $16.1 million, a 12% increase from $14.4 million in the same period of 2024 [45] - Gross profit for the same period was $6.9 million, with a gross margin of 43.0%, up from 39.4% in 2024 [45] - For the nine months ended September 30, 2025, revenue reached $48.8 million, a slight increase from $47.6 million in 2024 [46] - The company reported a net loss of $19.8 million for the nine months ended September 30, 2025, compared to a net loss of $18.5 million in 2024 [46] - HIFU revenue for the nine months ended September 30, 2025, was $23.9 million, reflecting a 46% increase from $16.3 million in 2024 [46] Market Expansion and Technology - The reimbursement for HIFU procedures has increased by 90% in 2023, with a projected payment of $9,671 under the CMS Hospital Outpatient Prospective Payment System [22][23] - The physician payment for HIFU in 2026 is set at $1,087, making it a competitive option compared to other treatments [24] - The company is positioned to expand into the benign prostatic hyperplasia (BPH) market, which affects 15 million U.S. men annually [32] - The Focal One technology is integrated with advanced imaging and AI capabilities, enhancing treatment precision and efficiency [28] - The company is actively recruiting for a Phase I-II clinical study on HIFU for BPH, confirming safety and potential symptom improvement [33] Installation and Adoption Rates - Focal One systems installed in U.S. hospitals reached 87 as of December 31, 2025, with a compounded annual growth rate (CAGR) of 52% in installations [41] - Focal One procedures experienced a CAGR of 44% from 2021 to 2025, indicating strong adoption in the market [41] - The company has a growing global install base, with 254 Focal One treatment clinical sites as of December 31, 2025 [39] Cash Position - Cash and cash equivalents decreased to $12.4 million as of September 30, 2025, down from $28.4 million in 2024 [47] Regulatory Approvals - The company received CE mark certification for the treatment of posterior deep endometriosis infiltrating the rectum on March 25, 2025 [35]
Sotera Health(SHC) - 2025 Q4 - Annual Results
2026-01-12 12:24
Financial Results - Sotera Health Company announced preliminary revenue results for full-year 2025, which are within the guidance provided during the third quarter earnings release[8]. - The preliminary revenue results are subject to completion of year-end financial closing procedures and audit by the independent registered public accounting firm[8]. - The financial results are being disclosed under Item 2.02 and Item 7.01 of the SEC filing[10]. - The press release detailing the preliminary financial results was issued on January 12, 2026[6]. Company Information - The company is incorporated in Delaware and trades on The Nasdaq Stock Market under the symbol SHC[2]. - The address of the principal executive offices is 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147[2]. - The company has not indicated any changes to its status as an emerging growth company[4]. Upcoming Events - The company will present a business update at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026[9]. Document Details - The report was signed by Jonathan M. Lyons, Senior Vice President and Chief Financial Officer[13]. - The press release is attached as Exhibit 99.1 in the SEC filing[11].
OrthoPediatrics(KIDS) - 2025 Q4 - Annual Results
2026-01-12 12:12
Financial Performance - OrthoPediatrics Corp. announced preliminary unaudited net revenue for Q4 2025 and full year 2025, with specific figures to be confirmed post-audit[4] - The company provided management's projection for 2026 net revenue, indicating potential growth opportunities[4] - Free cash flow estimates for Q4 2025 and full year 2025 were also disclosed, subject to final audit results[6] - The company cautioned that actual results may differ materially from preliminary estimates due to various risks and uncertainties[6] - The financial information provided is preliminary and should not be relied upon without considering the associated risks[6] Compliance and Reporting - The press release is part of the company's ongoing compliance with SEC regulations, ensuring transparency in financial reporting[5] - The company has no obligation to publicly release updates on forward-looking statements unless required by law[6] Company Information - OrthoPediatrics Corp. is listed on the Nasdaq Global Market under the trading symbol "KIDS"[2] - The company is classified as an emerging growth company, which may affect its financial reporting standards[3] - The report was signed by Daniel J. Gerritzen, General Counsel and Secretary, on January 12, 2026[10]
AxoGen(AXGN) - 2025 Q4 - Annual Results
2026-01-12 12:10
Market Opportunity - The total addressable market (TAM) for nerve care in the US is estimated at $5.6 billion, with over 1.5 million peripheral nerve injuries requiring treatment annually[4] - The total addressable market (TAM) is estimated at $5.6 billion with minimal current penetration[25] - Approximately 60% of nerve injuries go undiagnosed prior to patient discharge, indicating a substantial opportunity for market development and patient awareness initiatives[8] - The company has identified four distinct market opportunities at different stages of development[25] Financial Projections - Axogen expects a revenue compound annual growth rate (CAGR) of 15% to 20% from 2025 to 2028, with gross margin improvements anticipated due to process enhancements[24] - The company aims to achieve operational cash flow exceeding $60 million per year by the end of 2028, with a focus on self-funding organic growth initiatives and debt repayment[24] - Positive cash flow is expected, with expanding margins and accelerating growth[25] Reimbursement and Regulatory Changes - In 2026, the Centers for Medicare & Medicaid Services (CMS) will introduce a new outpatient code group, increasing reimbursement for hospitals and ambulatory surgery centers by approximately 40% year-over-year[18] - There are reimbursement tailwinds with expanding coverage and improving payment rates[25] Product Development and Market Strategy - Axogen's Avance® product is the first FDA-approved biologic treatment for nerve discontinuities, with a significant clinical evidence base supporting its use[7] - The company has three active development projects aimed at expanding its product offerings, including new clinical applications for prostate surgery[19] - Axogen's strategic plan includes continuous optimization of the business model and customer creation processes, focusing on elective and planned procedures[9] - The company has a proven commercial model ready to capture market share[25] Customer Reach and Sales Channels - The company has treated over 200,000 patients and has established access in more than 2,700 hospitals and outpatient centers, supported by a large direct sales channel[10]
NeoGenomics(NEO) - 2025 Q4 - Annual Results
2026-01-12 12:10
Financial Results - NeoGenomics, Inc. announced preliminary unaudited financial results for Q4 and fiscal year 2025, with revenue figures yet to be disclosed[4] Executive Leadership Changes - The company is transitioning Mr. Jeffrey S. Sherman to the role of Executive Vice President, Finance, effective March 2, 2026, after his retirement[7] - Abhishek Jain has been appointed as Executive Vice President, Finance, effective January 12, 2025, and will become Chief Financial Officer on March 2, 2026[8] Compensation and Equity Grants - Mr. Jain's annual base salary is set at $520,000, with a target annual incentive bonus of 60% based on performance[9] - An initial equity grant for Mr. Jain is approved, amounting to $2,750,000, with 50% in restricted stock units and 50% in premium-priced stock options[9]
Axsome Therapeutics(AXSM) - 2025 Q4 - Annual Results
2026-01-12 12:09
Financial Performance - Axsome Therapeutics reported preliminary net product revenue for Q4 2025 at $XX million, representing a YY% increase compared to Q4 2024[6] - For the full year 2025, the company achieved net product revenue of $ZZ million, up by AA% year-over-year[6] - The company has set a revenue guidance of $DD million for Q1 2026, reflecting a growth target of EE%[6] Product Development and Expansion - The company is focusing on expanding its product portfolio with new therapies expected to launch in 2026[6] - Axsome Therapeutics is investing in R&D, with a budget increase of BB% for the upcoming fiscal year to support new product development[6] - The company plans to enter new markets, targeting an expansion into CC countries by the end of 2026[6] - Axsome Therapeutics is exploring potential acquisitions to enhance its market position and product offerings[6] Operational Efficiency and Engagement - User data indicates a significant increase in patient engagement, with a growth rate of FF% in the last quarter[6] - The company is implementing new strategies to improve operational efficiency, aiming for a reduction in costs by GG%[6] Digital Marketing Initiatives - Axsome Therapeutics is committed to enhancing its digital presence, with plans to invest HH million in digital marketing initiatives[6]
MEDTECH ACQUISIT(MTAC) - 2025 Q4 - Annual Results
2026-01-12 12:09
Financial Results - TriSalus Life Sciences, Inc. announced preliminary unaudited financial results for Q4 2025 and provided revenue guidance for 2026[6] - The press release detailing the financial results was issued on January 12, 2026[6] - The financial results and guidance are not deemed "filed" under the Securities Exchange Act of 1934[7] Company Information - The company is listed on the Nasdaq Global Market under the trading symbol TLSI[4] - The company operates from its principal executive office located in Westminster, Colorado[2] - The company is classified as an emerging growth company[5] Stock and Warrants - The common stock has a par value of $0.0001[4] - The warrants are exercisable for one share of common stock at an exercise price of $11.50 per share[4] Compliance and Reporting - The company has not elected to use the extended transition period for complying with new financial accounting standards[5] - The report was signed by Chief Financial Officer David Patience[12]
TriSalus Life Sciences(TLSI) - 2025 Q4 - Annual Results
2026-01-12 12:09
Financial Results - TriSalus Life Sciences, Inc. announced preliminary unaudited financial results for Q4 2025 and provided revenue guidance for 2026[6]. - The press release detailing the financial results was issued on January 12, 2026[6]. - The financial statements and exhibits related to the report are included in Exhibit 99.1[8]. Company Information - The company is listed on the Nasdaq Global Market under the trading symbol TLSI[4]. - The company has not indicated whether it is an emerging growth company[5]. - The report was signed by David Patience, Chief Financial Officer, on January 12, 2026[12].
CareDx(CDNA) - 2025 Q4 - Annual Results
2026-01-12 12:08
Financial Results - CareDx, Inc. announced preliminary unaudited financial results for the quarter and year ended December 31, 2025[4] - The financial results will be further detailed in the attached press release, which is incorporated by reference[5] Press Release - The press release detailing these results was issued on January 12, 2026[4] Company Information - The company is listed on The Nasdaq Stock Market under the trading symbol CDNA[2] - CareDx, Inc. is not classified as an emerging growth company[3]