Earnings release
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 1 ASX ANNOUNCEMENT 29 October 2026 Q1 FY27 Quarterly Activity Report and Appendix 4C12 Q1 FY27 Highlights: • Global revenue of US$23.1 million, +26% vs prior corresponding period (pcp), reflecting continued commercial momentum. • Quarterly US patient implants of 838, +55% vs pcp, supported by 47% growth in active physicians and improved physician utilisation. • US revenue of US$17.4 million, +34% vs pcp, with patient growth exceeding revenue growth, primarily reflecting customers’ use of inventory purchased in prior quarters and account mix, including increased activity in higher-volume ASCs with volume-based pricing. • International revenue of US$5.8 million, +7% vs pcp, driven primarily by growth in Australia and Germany. • Approximately 75% of the US sales force fully trained, with approximately 50% of viable US territories covered by at least one fully trained rep. • Full US commercial release of CAP24™ underway, expanding access to the first and only FDA- approved surgical paddle lead designed for physiologic, dose-controlled closed-loop therapy. • Mike Mathias appointed Chief Executive Officer, transitioning from Chief Commercial Officer. • FY27 guidance reaffirmed. • Investor webinar to be held today, 29 October 2026 at 12:30pm AEDT (click to register). Saluda Medical, Inc. (ASX:SLD, “Saluda” or the “Company”), a commercial -stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed - loop neuromodulation platform, is pleased to provide this activity report and Appendix 4C for the quarter ended 30 September 2026 (“Q1 FY27”, “Q1” or the “September quarter”). Commenting on the release, Saluda’s Chief Executive Officer, Mike Mathias, said: “Q1 was a solid start to FY27. A record number of US patients were implanted, up 55% compared to last year, and the number of active physicians implanting Evoke® in the quarter grew 47%. Those are the clearest signs of increasing demand for physiologic closed-loop therapy in the market. During the quarter, US patient growth outpaced US revenue growth as certain customers used inventory purchased in prior quarters and due to account mix, including Saluda’s increased activity in higher-volume ASC accounts. Additionally, while our international business has a higher level of quarter-to-quarter variability in ordering patterns, we continue to see increased demand for our products in key markets, reinforcing our confidence in the international growth opportunity. 1Financial results, including revenue, have not yet been reviewed by the Company’s independent auditors. 2All financial results are reported in USD unless otherwise noted.
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 2 Since quarter-end, we have moved CAP24 into full US commercial release, which opens the surgical paddle segment to Evoke therapy. This represents another important step in the commercial strategy we have been executing over the past two years, focused on expanding physician access to Evoke therapy and building a commercial organisation capable of supporting broader adoption. With a larger, progressively maturing sales force and a growing base of physicians, we remain focused on delivering value to our customers and their patients.” Operational update Saluda continued to make good operational progress through the September quarter, reflected by total quarterly revenue growth of 26% versus pcp, including 34% US revenue growth versus pcp, continued growth in US implanted patients, expansion of the US implanting physician base, and ongoing scaling of its commercial organisation. The Company’s Q1 strategic priorities remained focused on disciplined commercial execution, increasing physician adoption and utilisation, expanding awareness of objective neural data and physiologic closed-loop spinal cord stimulation (“SCS”), progressing key product development projects, and preparing for the full commercial release of the CAP24 paddle lead. The Company also advanced its physician education and market development activities throughout the quarter, including at the American Society of Pain and Neuroscience ("ASPN") conference in July (see "Commercial execution" below). In parallel, the Company continued to progress product development across in-process projects. On 7 September 2026, Saluda announced the appointment of Mike Mathias as Chief Executive Officer. Mr. Mathias joined Saluda as Chief Commercial Officer in November 2024 and has led the Company's global commercial strategy and execution. He has more than 30 years of healthcare and medical technology experience, including senior commercial and operational leadership roles at Medtronic, LimFlow and Endologix. His knowledge of Saluda's technology, patient-centric mission and customers, together with his focus on executing the Company’s strategic priorities, underpins his appointment. Global commercial momentum Q1 global revenue increased 26% versus pcp to US$23.1 million. US revenue increased 34% versus pcp to US$17.4 million and international revenue increased 7% versus pcp to US$5.8 million. Revenue declined sequentially from US$27.0 million in Q4 FY26, the Company's strongest quarter to date. The September quarter is seasonally softer for Saluda because of the northern-hemisphere summer holiday period for patients and physicians (US and Europe). Q4 FY26 also included approximately US$0.6 million of international revenue from the recognition of deferred revenue in Europe following the EVA™ automated programming launch.
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 3 Q1 FY27 Q1 FY26 Growth vs. PCP US Revenue ($m) 17.4 12.9 34% Int’l Revenue ($m) 5.8 5.4 7% Total Revenue ($m) 23.1 18.3 26% # of US Patients Implanted 838 542 55% US Avg. Quarterly Active Implanting Physicians 374 254 47% US Commercialisation US commercial momentum continued to build in Q1 as 838 US patients were implanted, up 55% versus pcp and 9% above Q4 FY26 notwithstanding the normal fiscal Q1 seasonality impact. The average number of active implanting US physicians for the quarter increased 47% versus pcp to 374, and active physician utilisation increased 5% versus pcp. Performance was supported by the continued expansion and maturation of Saluda’s trained US sales force, increased physician engagement and education, and continued adoption in higher-volume Ambulatory Surgical Centre (“ASC”) accounts. US revenue grew 34% versus pcp, compared with 55% growth in implanted patients. Two factors contributed to the difference: • Customer inventory timing: Certain customers purchased product ahead of implant volumes in Q4 FY26 and used part of that inventory in Q1 FY27. As a result, product invoiced during the quarter did not directly track the number of patients implanted; and • Account mix and volume-based pricing: Saluda increased its share of higher-volume ASC accounts during the second half of FY26. Volume-based pricing in those accounts reduced average selling price compared with Q1 and Q2 FY26, although average selling price remained broadly stable compared with Q4 FY26. Saluda generally recognises revenue when product is sold to customers, while implanted patient data reflects procedures performed. Customer purchasing patterns and procedure timing can therefore cause quarterly revenue and implant growth rates to differ.
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 4 International performance International revenue increased 7% versus pcp to US$5.8 million. Growth in Australia and several European countries, including Germany, was partially offset by buying patterns in certain other European countries in the quarter. Saluda also commenced sales in Austria during the quarter, creating another growth opportunity supported by existing sales resources. Q1 FY27 growth is on a like-for-like basis with pcp, as neither Q1 FY27 nor Q1 FY26 included any benefit from the recognition of deferred revenue in Europe following the EVA launch. That change contributed approximately US$0.7 million in Q3 FY26 and US$0.6 million in Q4 FY26. EVA automated programming technology is now in full commercial use across all of Saluda's commercial geographies. It remains an important enabler of more efficient programming workflows and a more consistent physician and patient experience. 511 542 670 695 769 838 254 254 291 288 311 374 - 100.0 200.0 300.0 400.0 500.0 600.0 700.0 800.0 900.0 Q4 FY25 Q1 FY26 Q2 FY26 Q3 FY26 Q4 FY26 Q1 FY27 Quarterly US Patient & Physician Activity US Implanted Patients US Avg Qtrly Active Physicians 12.7 12.9 15.4 16.4 18.4 17.4 6.2 5.4 5.6 7.4 8.5 5.8$18.9M $18.3M $21.0M $23.8M $27.0M $23.1M Q4 FY25 Q1 FY26 Q2 FY26 Q3 FY26 Q4 FY26 Q1 FY27 Quarterly Revenue Trend by Geography US Int'l ASX IPO
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 5 CAP24™ paddle lead full commercial release underway Following Saluda’s US FDA approval of its newly designed CAP24 paddle lead in June, the Company began commercialisation with a limited market release in Q1 FY27 in selected centres. The Company announced the full US commercial release after the September quarter end. CAP24 is now being made broadly available to neurosurgery and orthopaedic spine practices across the US, following completion of the successful limited market release. During the limited release, physicians provided positive feedback on the device’s performance and its integration into clinical practice. Saluda began its limited market release with approximately 10 US accounts to gather initial feedback and then expanded this number during Q1 FY27. As the Company has entered its full commercial release phase in the US, the commercial organisation is focused on growing the number of activated accounts in which physicians can begin using paddle leads to deliver physiologic, dose-controlled closed-loop therapy. CAP24 is the first and only FDA-approved surgical paddle lead for physiologic, dose-controlled closed- loop therapy. It enables the Evoke System to measure each patient’s unique neural response and adapt stimulation with every pulse. Its low-profile, anatomically contoured design supports stable placement and broad coverage. Critically, CAP24 expands Saluda into a previously unaddressed segment of the SCS market and broadens the number of physicians able to utilise Evoke therapy. Access to this paddle lead market segment, which generated an estimated US$670 million in revenue in 2024, represents approximately 30% of the total US SCS market. Commercial execution: sales force scaling, EVA™ enablement and physician training Saluda continued to execute its US-led commercialisation strategy during the September quarter. At the end of September 2026, Saluda had approximately 50% of the total viable US market territories covered with at least one fully trained rep, up from 45% at the end of June 2026, and approximately 75% of its US sales force is fully trained. After the significant expansion of the sales force through FY26, a growing share of representatives are now completing training and ramping up in their territories. As outlined in the FY26 annual results, Saluda expects to keep growing the US sales force in FY27, but at a reduced rate, with focus shifting to productivity and reductions in territory selling costs as a percentage of the revenue they generate. During the quarter, Saluda had a significant presence at ASPN in Miami. Activities included scientific presentations, customer meetings, peer-led education programs and engagement around the Evoke System, EVA automated programming and CAP24 paddle lead. Saluda continued to engage with healthcare professionals during the quarter through national, regional and local education programs. These activities support both new physician adoption and increased utilisation among existing customers.
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 6 Cash flows from operations Cash on hand at the end of Q1 FY27 was US$73.6 million, compared with US$116.4 million at the end of Q4 FY26. Cash used in operations during Q1 FY27 was US$42.7 million, compared with US$28.9 million in Q4 FY26. Q1 FY27 operating cash use included several payments that were concentrated in the quarter, including US$4.5 million of annual employee incentive payments relating to FY26 performance, US$2.0 million of executive retention payments previously disclosed in the IPO prospectus and accrued over the preceding 18 months, approximately US$2.4 million relating to two large non-recurring project related payments, and approximately US$2.5 million arising from the timing of inventory-related payments around quarter-end. Cash use also reflected the ongoing cost of the Company’s expanded US commercial organisation. Non-commercial personnel and project expenditure remained broadly consistent with levels in the second half of FY26. The Company expects operating cash use in the remaining quarters of FY27 to be lower than in Q1 FY27, as several payments concentrated in Q1 are not expected to recur in the remainder of the fiscal year. Appendix 4C item 6.1 includes US$1.8 million of payments to related parties for executive and non- executive salary and fees paid to the former and current CEOs and to directors in their capacity in these roles. These payments include the annual bonuses and retention payments referenced above. FY27 guidance Saluda reaffirms the following guidance for FY27: • Revenue growth: 25% to 35% growth on FY26 revenue; • Gross margin: 50% to 52%; and • Adjusted EBITDA loss: US$101 million to US$95 million. Additional outlook and guidance commentary was provided in the Company’s FY26 results release on 28 August 2026. Given the one-time nature of certain payments concentrated in Q1 FY27, the Company expects the remaining three quarters of cash usage to revert to levels similar to prior quarters. Based on the FY27 guidance and the Company’s current operating plan, Saluda estimates that its existing cash resources provide runway to approximately June 2027. Use of funds In accordance with Listing Rule 4.7C.2, below is a comparison of actual expenditure since the Company’s admission date through the end of Q1 FY27 to the use of funds statement included in the Company’s IPO prospectus. In addition to the US$150 million raised in the Company’s IPO, Saluda drew an additional US$25 million of debt from its existing facility in Q4 FY26 supporting its Q1 FY27 ending cash balance of US$73.6 million. The Company expects operating cash use in the remaining quarters of FY27 to be lower than in Q1 FY27, as several payments concentrated in Q1 are not expected to recur in the remainder of the fiscal year.
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 7 Per prospectus % of funds raised Use of funds for the period * % of funds used (US$000) (US$000) Expansion of sales teams 62,900 41.9% 45,975 38.3% Marketing and commercial support 17,700 11.8% 13,477 11.2% Product development related activities 13,300 8.9% 10,190 8.5% Clinical, regulatory & quality 8,600 5.7% 5,034 4.2% Costs of the Offer and the US Private Placement 9,300 6.2% 10,508 8.7% General & Administrative Costs 21,500 14.3% 17,313 14.4% Interest expense on debt 7,100 4.7% 5,738 4.8% Working Capital 9,600 6.4% 11,922 9.9% 150,000 120,157 * Use of funds from IPO proceeds is from admission date (3 December 2025) through the end of the first quarter of FY27 (30 September 2026). The Company considers that the use of funds is on track with the disclosure in the IPO prospectus. Quarterly investor webinar Saluda will host an investor webinar to discuss its Q1 FY27 results on Thursday, 29 October 2026 at 12:30pm AEDT. The webinar will be hosted by Saluda’s Chief Executive Officer, Mike Mathias, and Chief Financial Officer, James Erickson. Register and/or access webinar replay via the link below: https://us02web.zoom.us/webinar/register/WN_oUJTwT9iT2-gQadACtaj9w This announcement has been authorised for release by Saluda Medical’s Board of Directors. For more information, please contact: Investors Media James Erickson Chief Financial Officer investors@saludamedical.com Sam Wells NWR Communications +61 (0) 427 630 152 sam@nwrcommunications.com.au Matt Wright NWR Communications +61 (0) 451 896 420 matt@nwrcommunications.com.au About Saluda Medical Saluda Medical, Inc. (ARBN 691 140 360) is a commercial-stage medical device company focused on developing treatments for chronic neurological conditions using its novel neuromodulation platform. The Company’s closed-loop, dose-control platform senses and measures neural responses to stimulation and automatically adjusts therapy based on real-time neurophysiological feedback. The Company’s first product, the Evoke® System, is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low
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SALUDA MEDICAL, INC. ARBN 691 140 360 9401 James Ave S, Suite 132 Bloomington MN 55431, United States 8 back pain, and leg pain, and is designed to treat chronic neuropathic pain by providing spinal cord stimulation (SCS) therapy that senses and measures neural activation to optimize therapy and reduce patient and clinician burden. 12-month results from the EVOKE study, the first and only prospective, multi - center, parallel-arm, double blind, randomized controlled pivotal study with a voluntary crossover arm in SCS, that demonstrated clinically superior pain relief to open -loop therapy, were published in The Lancet Neurology, 24-month results were published in JAMA Neurology, and 36 -month data, that demonstrated sustained pain relief, were published in Regional Anesthesia and Pain Medicine. To learn more, including risks and important safety information, visit www.saludamedical.com/us/safety/. Saluda and Evoke® are registered trademarks owned by Saluda Medical Pty Ltd. Foreign Ownership Restriction Saluda’s CHESS Depositary Interests (CDIs) are issued in reliance on Regulation S under the U.S. Securities Act of 1933, as amended (the U.S. Securities Act), and a no -action letter issued by the staff of the U.S. Securities and Exchange Commission. Accordingly, the Company’s CDIs have not been, and will not be, registered under the U.S. Securities Act (except pursuant to an effective registration statement) or the securities laws of any state or other jurisdiction in the United States. The holders of Saluda’s CDIs may not offer, sell, pledge, or otherwise transfer the CDIs into the United States or to, or for the account or benefit of, a “U.S. Person” (as defined in Rule 902(k) of Regulation S under the U.S. Securities Act) for a period of at least 12 months from the allotment date under the IPO, unless the resale of the CDIs is registered under the U.S. Securities Act or an exemption from registration is available .