Medical Devices
Search documents
INVESTIGATION REMINDER: Faruqi & Faruqi, LLP Investigates Claims on Behalf of Investors of Beta Bionics
TMX Newsfile· 2026-02-18 01:13
Core Insights - Faruqi & Faruqi, LLP is investigating potential claims against Beta Bionics, Inc. due to significant stock losses experienced by investors [2][4] - Beta Bionics' stock (NASDAQ: BBNX) dropped approximately 37% on January 9, 2026, following the company's announcement of lower-than-expected patient starts for the fourth quarter [4] Company Overview - Beta Bionics, Inc. is a publicly traded company listed on NASDAQ under the ticker BBNX [2] - The company has faced scrutiny regarding whether it issued misleading statements or failed to disclose critical information to investors [4] Legal Context - Faruqi & Faruqi, LLP is a national securities law firm with a history of recovering hundreds of millions of dollars for investors since its establishment in 1995 [3] - The firm is encouraging investors who have suffered significant losses in Beta Bionics to discuss their legal options [1][2]
Glaukos (GKOS) Reports Q4 Earnings: What Key Metrics Have to Say
ZACKS· 2026-02-18 00:01
Core Insights - Glaukos reported revenue of $143.12 million for Q4 2025, a year-over-year increase of 35.7% and slightly above the Zacks Consensus Estimate of $142.93 million, resulting in a surprise of +0.13% [1] - The company reported an EPS of -$0.28, which is an improvement from -$0.40 a year ago, but fell short of the consensus estimate of -$0.22, leading to an EPS surprise of -26.47% [1] Revenue Performance - International Glaucoma revenues reached $32.78 million, exceeding the average estimate of $31.67 million by six analysts, representing a year-over-year increase of +17.6% [4] - United States Glaucoma revenues were reported at $86.4 million, surpassing the average estimate of $81.11 million, with a significant year-over-year change of +53.5% [4] - Net Sales for Corneal Health amounted to $24 million, exceeding the average estimate of $21.06 million, reflecting a year-over-year increase of +12.4% [4] - Net Sales for Glaucoma totaled $119.2 million, above the average estimate of $112.79 million, indicating a year-over-year change of +41.7% [4] Stock Performance - Over the past month, Glaukos shares have returned -9%, compared to a -1.4% change in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]
Beta Bionics Q4 Earnings Call Highlights
Yahoo Finance· 2026-02-18 00:00
Core Insights - Beta Bionics reported significant growth in net sales for 2025, reaching $100.3 million, a 54% increase year-over-year, with Q4 sales at $32.1 million, up 57% year-over-year [2][6] - The company emphasized its strategy to enhance access through pharmacy reimbursement, with new patient starts through pharmacy rising to the high 20s percentage for full-year 2025, compared to a high single-digit percentage in the previous year [1][6] - CEO Sean Saint noted that nearly 20,000 new users adopted the iLet in 2025, more than doubling the installed base to over 35,000 users since launch [2][6] Financial Performance - Beta Bionics achieved a gross margin of 55.4% for 2025, slightly expanding from the prior year, with Q4 gross margin at 59%, an increase of 179 basis points year-over-year [2][7] - The company guided for 2026 revenue between $130 million and $135 million, with a gross margin forecast of 55.5% to 57.5% [10][19] - Operating expenses for Q4 were reported at $35.1 million, up from $24.7 million in Q4 2024, driven by increased sales and marketing efforts and R&D investments [9] Product Pipeline and Development - Progress on the Mint patch pump is on track for an unconstrained commercial launch by the end of 2027, with successful first-in-human feasibility testing of the bihormonal system showing no glucagon safety signals [4][16][17] - Approximately 25% to 30% of Q4 new patient starts were off-label type 2 diabetes users, indicating potential for expanding the product label through the FDA [4][18] - The company is exploring a type 2 label and plans to leverage existing pharmacy relationships for the Mint product coverage [16][18] Regulatory and Compliance - A late-January FDA warning letter highlighted quality-system observations from a June inspection, with the company beginning remediation efforts immediately and expecting compliance by the end of Q2 [5][14][15] - Key areas of concern from the FDA included complaint handling, medical device reporting, and corrective and preventative action practices [15] Market Strategy and Expansion - Management plans to add at least 20 sales territories in 2026, with much of the expansion occurring in the first half of the year [13] - The company reported a modest pull-forward of about $1 million in pharmacy stocking orders from Q1 into Q4 ahead of end-of-year price increases [7] - Approximately 69% of Q4 new patient starts came from individuals previously using multiple daily injections, indicating the iLet's potential to expand the pump market [8]
AtriCure Q4 Earnings Call Highlights
Yahoo Finance· 2026-02-18 00:00
Fourth-quarter gross margin was 75%, up 45 basis points year over year, driven primarily by favorable product mix. AtriCure reported fourth-quarter net income of $1.8 million versus a $15.6 million net loss a year earlier, and adjusted EBITDA of $19.9 million versus $12.7 million in 2024. EPS was $0.04 and adjusted EPS was $0.06, compared with a loss per share of $0.33 and adjusted loss per share of $0.08 in the prior-year quarter.In the fourth quarter, worldwide revenue was $140.5 million, increasing 13.1% ...
Tactile Systems Technology(TCMD) - 2025 Q4 - Earnings Call Transcript
2026-02-17 23:02
Tactile Systems (NasdaqGM:TCMD) Q4 2025 Earnings call February 17, 2026 05:00 PM ET Company ParticipantsBen Haynor - Managing DirectorElaine Birkemeyer - CFOKyle Winborne - Equity ResearchSam Benzinger - Investor RelationsSheri Dodd - CEOConference Call ParticipantsBrandon Vasquez - Research AnalystNone - AnalystOperatorPlease stand by. Welcome, ladies and gentlemen, to the fourth quarter and full year 2025 earnings conference call for Tactile Medical. At this time, all participants have been placed in list ...
Tactile Systems Technology(TCMD) - 2025 Q4 - Earnings Call Transcript
2026-02-17 23:00
Financial Data and Key Metrics Changes - Total revenue for the full year 2025 was $329.5 million, a 12% increase year-over-year [4] - Full year gross margins expanded by 190 basis points year-over-year to 75.9% [5] - Adjusted EBITDA increased 21% year-over-year to $44.8 million [5] - Q4 total revenue grew by 21% year-over-year to $103.6 million [28] - Q4 gross margin was 78.2%, compared to 75.2% in Q4 2024 [28] - Net income increased by 9% to $10.6 million, or $0.46 per diluted share [30] Business Line Data and Key Metrics Changes - Lymphedema revenue increased 16% year-over-year to $89.5 million in Q4 [6] - Airway clearance revenue increased 66% year-over-year to $14.1 million in Q4 [6] - Sales and rentals of lymphedema products increased by $12.4 million, or 16% [28] - Sales of airway clearance products increased by $5.6 million, or 66% [28] Market Data and Key Metrics Changes - The company expects total revenue for 2026 to be in the range of $357 million to $365 million, representing year-over-year growth of 8% to 11% [6][31] - The Medicare channel remained strong in Q4, with patients moving directly to the Flexitouch Advanced pump under new NCD criteria [10] Company Strategy and Development Direction - The acquisition of LymphaTech is a significant milestone, expanding the company's capabilities in lymphedema solutions and enhancing R&D [8][15] - Strategic priorities include improving access to care, expanding treatment options, and enhancing lifetime patient value [9][25] - The company aims to leverage AI technology to improve order processes and operational efficiency [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the new Medicare prior authorization requirements, viewing them as a short-term headwind [31][46] - The company believes it is well-positioned to continue delivering growth in line with the overall lymphedema market [33] - Management highlighted the importance of ongoing investments in people and technology to support future growth [37] Other Important Information - The company ended 2025 with $83.4 million in cash and cash equivalents and generated close to $43 million in operating cash flow during the year [5] - The company has no outstanding borrowings as of the end of Q4 2025 [30] Q&A Session Summary Question: What drove the strong performance in the lymphedema business in Q4? - Management noted multiple investments in people, processes, and technology, including strong CRM adoption and increased sales rep productivity [41][42] Question: How do the new prior authorization requirements balance with the tailwinds from the NCD? - Management indicated that the guidance reflects a balanced approach, incorporating both tailwinds from the NCD and the headwinds from prior authorization [44][46] Question: Can you elaborate on the LymphaTech acquisition and its commercialization model? - Management expressed excitement about integrating LymphaTech into their commercial engine, focusing on measurement and surveillance for lymphedema [53][55] Question: What are the expectations for EBITDA margin growth moving forward? - Management indicated that while EBITDA margins are expected to grow modestly in 2026, long-term growth is anticipated as investments are completed [68]
Glaukos(GKOS) - 2025 Q4 - Earnings Call Transcript
2026-02-17 22:32
Financial Data and Key Metrics Changes - Glaukos reported record fourth quarter consolidated net sales of $143.1 million, up 36% on a reported basis and 34% on a constant currency basis compared to the year-ago quarter [7] - For the full year of 2025, consolidated record net sales reached $507.4 million, growing 32% versus 2024 [7] - The company reaffirmed its full year 2026 net sales guidance range of $600 million to $620 million, implying over 20% year-over-year growth at the midpoint [7] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record fourth quarter net sales of $86.4 million, reflecting a strong year-over-year growth of 53%, driven by iDose TR, which generated approximately $45 million in sales during the fourth quarter [9] - The international glaucoma franchise delivered net sales of $32.8 million, with year-over-year growth of 18% on a reported basis and 13% on a constant currency basis [11] - The corneal health franchise reported net sales of $24 million, with year-over-year growth of 12%, including T-Rex, which generated net sales of $21.4 million [12] Market Data and Key Metrics Changes - The company noted strong physician adoption of iDose TR, with sales of approximately $136 million in 2025, indicating positive clinical outcomes and growing contributions [9] - The international market is expected to face competitive product trialing headwinds in major markets, partially offset by growing contributions from iStent infinite following its EU MDR certification [11] Company Strategy and Development Direction - Glaukos aims to advance the interventional glaucoma treatment paradigm with iDose TR and the launch of Epioxa, targeting new markets in interventional keratoconus and rare diseases [8] - The company is focused on capital allocation, emphasizing ROI-driven investments and cash flow while advancing a robust industry-leading pipeline [9] - The FDA approval of Epioxa is seen as a significant milestone, allowing the company to redefine its go-to-market approach and expand patient care access [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong growth momentum into 2026, driven by transformational growth drivers [8] - The company anticipates continued sequential growth in iDose TR, despite being a seasonally low quarter for procedure volumes [30] - Management acknowledged potential volatility in the corneal health franchise due to the transition from Photrexa to Epioxa, expecting modest growth year-over-year [36] Other Important Information - Glaukos has invested over $1 billion in R&D since inception, focusing on chronic and rare ophthalmic diseases [21] - The company is committed to pioneering new marketplaces within ophthalmology, emphasizing innovation as a core value [22] Q&A Session Summary Question: Can you elaborate on early positive coverage determinations for Epioxa? - Management noted that early positive outcomes have been observed with a handful of Medicaid societies and one of the larger blue plans, with no formal pushback on pricing dynamics [25] Question: What drove the sequential deceleration in iDose revenue in Q4? - Management indicated that the mix shift towards Medicare Advantage and specific dynamics related to glaucoma procedures impacted revenue, but they expect continued growth in Q1 [29] Question: Can you provide more detail on the components of the FY 2026 guidance? - Management expects high single-digit growth internationally, with U.S. glaucoma growth driven entirely by iDose TR, while corneal health is expected to grow modestly with some volatility [35][36] Question: How do you view the interplay between iDose and T-Rex? - Management emphasized the goal of providing multiple treatment options for patients, with expectations for different surgeons to choose based on clinical profiles [48] Question: What are the expectations for operating expenses in 2026? - Management anticipates mid-teen year-over-year growth in operating expenses, aiming for cash flow break-even and potential cash flow generation [52]
Medtronic Tops Fiscal Q3 Estimates as Cardiovascular Segment Drives Growth
Financial Modeling Prep· 2026-02-17 22:12
Core Viewpoint - Medtronic plc reported fiscal third-quarter 2026 results that exceeded analyst expectations, although shares experienced a decline of over 2% intra-day following the release [1] Financial Performance - The company generated revenue of $9.0 billion, reflecting an 8.7% increase on a reported basis and 6.0% organic growth year over year, surpassing the consensus estimate of $8.89 billion [2] - Adjusted earnings per share were reported at $1.36, slightly above expectations of $1.34 [2] - The quarter marked the strongest enterprise revenue growth for the company in 10 quarters [2] Segment Performance - The Cardiovascular Portfolio led the performance with revenue climbing 13.8% as reported and 10.6% organically to $3.46 billion, with Cardiac Ablation Solutions showing particularly strong results, including an 80% increase in global revenue and a 137% surge in U.S. revenue [3] - Other segments also reported gains: the Neuroscience Portfolio increased 4.1% to $2.56 billion, the Medical Surgical Portfolio rose 4.9% to $2.17 billion, and the Diabetes segment grew 14.8% to $796 million [4] Outlook - Medtronic reaffirmed its fiscal 2026 outlook, maintaining expectations for approximately 5.5% organic revenue growth and adjusted EPS between $5.62 and $5.66, which includes a potential $185 million headwind from tariffs [4]
Beta Bionics Inc(BBNX) - 2025 Q4 - Earnings Call Presentation
2026-02-17 21:30
Other factors that may cause the Company's actual results to differ from current expectations are discussed in the Company's filings with the Securities and Exchange Commission (the "SEC"), including the section titled "Risk Factors" in the Company's Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on October 28, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation is given. Except as required by law, ...
SI-BONE To Present at TD Cowen 46th Annual Health Care Conference on March 2, 2026
Globenewswire· 2026-02-17 21:30
Company Overview - SI-BONE, Inc. is a global leader in developing procedural solutions for clinical challenges related to compromised bone [3] - The company specializes in biomechanical design and innovations specific to anatomy, focusing on spinopelvic anatomy [3] - Since its inception in 2009, SI-BONE has supported over 140,000 procedures, backed by clinical evidence including four randomized controlled trials and over 180 peer-reviewed publications [3] Upcoming Events - SI-BONE will participate in the TD Cowen 46th Annual Health Care Conference in Boston, MA, hosting a fireside chat on March 2, 2026, at 7:30 a.m. Pacific Time [1] - Investors can listen to the conference call by registering through a provided link, with live audio available on the company's website [2]