Funding Anticipated to Accelerate Applications Already in Use and New Additional Potential Applications Anticipated Preferred Stock Exchange to Simplify Capital Structure Private Placement Expected to Fund Business to Profitability Healthcare Focused Long-term Investors Support Strategic Vision DENVER–(BUSINESS WIRE)–TriSalus Life Sciences, Inc. (Nasdaq: TLSI) (the “Company”), an oncology focused medical technology […]
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Surmodics Reports Second Quarter of Fiscal Year 2025 Financial Results; Introduces Fiscal Year 2025 Financial Guidance
EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, today reported financial results for its second quarter ended March 31, 2025, and introduced its financial guidance for the fiscal year ending September 30, 2025. Second Quarter Fiscal […]
Idorsia announces financial results for the first quarter 2025 – QUVIVIQ taking off in Europe and TRYVIO REMS removal increases the value of this outstanding asset
Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland – April 30, 2025Idorsia Ltd (SIX: IDIA) today announced its financial results for the first quarter of 2025. Business highlights Q1 2025 QUVIVIQ™ (daridorexant): Strong performance and accelerating sales in Q1 2025 with total Idorsia-led net sales of CHF 25 m.QUVIVIQ EUCAN: Demand grew by 50% from Q4 2024 to Q1 2025, strongly driven by reimbursed markets. Overall, more than 10 million nights of sleep prescribed in Q1 2025.Daridorexant: Positive data with daridorexant in patients with chronic insomnia and nocturia published in the Journal of Sleep Research and assessing the transition from night to day published in Sleep Medicine.TRYVIO™ (aprocitentan): REMS requirement removed by US FDA.Aprocitentan: Effect of reducing blood pressure and proteinuria in Black patients with resistant hypertension published in HypertensionRestructured convertible bond debt: Tailored approach to remove large debt overhang.New funding: Bondholders to provide CHF 150 m new money facility.Viatris collaboration: Updated agreement removed significant cash requirement for 2025. Financial highlights Net revenue Q1 2025 of CHF 59 m.US GAAP operating expenses Q1 2025 of CHF 5 m (income) were positively impacted by a one-off gain from the amendment of the Viatris deal with non-GAAP operating expenses Q1 2025 of CHF 78 m.US GAAP operating income Q1 2025 of CHF 67 m and non-GAAP operating loss of CHF 17 m. Guidance for 2025 – unforeseen events excluded QUVIVIQ net sales of around CHF 110 m.SG&A expenses of around CHF 210 m, R&D expenses of around CHF 100 m, leading to non-GAAP operating expenses of around CHF 325 m.US GAAP loss for global business of around CHF 125 m. André C. Muller, Chief Executive Officer of Idorsia, commented:“Beyond the transformation of Idorsia’s financial situation, we made significant progress on multiple fronts in the first quarter. QUVIVIQ is taking off in Europe with a particularly impressive performance in France following the commercial partnership to call on GPs initiated in October 2024; we hope Germany will follow suit, as a similar partnership will kick-in from April 2025. In the US, we have implemented a focused commercialization approach for QUVIVIQ to maintain sales until the potential descheduling of the dual orexin receptor antagonist (DORA) class can be achieved. We received great news from the FDA, with the removal of the REMS requirement for TRYVIO allowing a shift toward broad product availability in retail pharmacies. This, together with the early positive prescribing experience in leading US hypertension centers of excellence gives us confidence of the potential of our antihypertensive drug. Lastly, we streamlined the R&D organization to invest in our promising refocused pipeline. All these achievements put us on a solid path to reach our 2025 goals.” Financial results US GAAP results First Quarterin CHF millions, except EPS (CHF) and number of shares (millions) 20252024Net revenue 5910Operating expenses 520Operating income 6731Net income 6330Basic EPS 0.330.17Basic weighted average number of shares 188.9179.1Diluted EPS 0.230.13Diluted weighted average number of shares 270.8233.3 Net revenue of CHF 59 m in Q1 2025 resulted from QUVIVIQ product sales (CHF 25 m), product sales to partners (CHF 1 m), and contract revenues (CHF 32 m), comprising a one-off exclusivity fee of CHF 32 m paid by an undisclosed party in relation to a potential aprocitentan deal, and non-cash revenue related to the R-Bridge royalty monetization agreement of CHF 1 m. This compares to net revenue of CHF 10 m in Q1 2024 from QUVIVIQ product sales. US GAAP operating expenses of CHF 5 m (income) in Q1 2025 and CHF 20 m (income) in Q1 2024 were impacted by a one-off gain of CHF 90 m (Viatris deal amendment) in 2025 and CHF 125 m (Viatris deal) in 2024, respectively. Excluding these one-off gains, US GAAP operating expenses at Q1 2025 decreased by CHF 20 m, mainly driven by R&D expenses of CHF 27 m decreasing by CHF 6 m compared to Q1 2024 (CHF 33 m), and SG&A expenses of CHF 54 m decreasing by CHF 14 m compared to Q1 2024 (CHF 68 m). US GAAP net income in Q1 2025 of CHF 63 m (CHF 27 m net loss excluding Viatris deal amendment) and CHF 30 m in Q1 2024 (CHF 95 m net loss excluding Viatris deal). Excluding these one-offs, the reduced net loss in Q1 2025 was primarily due to lower operating expenses from cost savings through the effective restructuring efforts announced in November 2024 and higher revenue. The US GAAP net income resulted in a basic net income per share of CHF 0.33 (diluted net income per share of CHF 0.23) in Q1 2025, compared to a basic net income per share of CHF 0.17 (diluted net income per share of CHF 0.13) in Q1 2024. Non-GAAP* measures First Quarterin CHF millions, except EPS (CHF) and number of shares (millions) 20252024Net revenue 5810Operating expenses (78)(96)Operating loss (17)(85)Net loss (25)(86)Basic and diluted EPS (0.13)(0.48)Basic and diluted weighted average number of shares 188.9179.1 * Idorsia measures, reports, and issues guidance on non-GAAP operating performance. Idorsia believes that these non-GAAP financial measurements more accurately reflect the underlying business performance and therefore provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance. Non-GAAP net loss in Q1 2025 amounted to CHF 25 m; the difference versus US GAAP net income was mainly driven by the one-off gain from the amendment of the Viatris Deal (CHF 90 m). The non-GAAP net loss resulted in a net loss per share of CHF 0.13 (basic and diluted) in Q1 2025, compared to a net loss per share of CHF 0.48 (basic and diluted) in Q1 2024. Viatris collaborationIn March 2024, Idorsia entered into a global research and development collaboration with Viatris, for the global development and commercialization rights to selatogrel and cenerimod. Idorsia received an upfront payment of USD 350 million (CHF 308 million) with Idorsia obligated to contribute USD 200 million for the development of selatogrel and cenerimod. Idorsia is entitled to potential development and regulatory milestone payments, and certain contingent payments of additional sales milestone payments and tiered royalties in the mid-single to low-double digit percentages on annual net sales. In February 2025, Idorsia reached an agreement with Viatris to update the terms of the collaboration. In exchange for a USD 100 million reduction to Idorsia’s contribution to the development costs due in 2025, Idorsia has agreed to a USD 250 million reduction in future potential regulatory and sales milestone payments, and an expansion of territorial rights to Viatris for cenerimod. The agreed royalties on future sales remain unchanged. Under the updated terms, Idorsia’s contribution for the development of selatogrel and cenerimod is reduced to USD 100 million with no commitment in 2025. Idorsia has contributed USD 73 million in 2024 for the performance of development services, and the remaining USD 27 million will be paid in 2026. Restructured convertible bond debt and new funding securedOn February 26, 2025, Idorsia announced that it has reached an agreement with more than two-thirds of the holders of its outstanding convertible bond debt on the main terms of a holistic restructuring of the bonds and a CHF 150 million new money facility, to alleviate the short- to mid-term debt overhang of CHF 800 million while retaining upside potential of key assets beyond the value of the debt. As part of the holistic restructuring Idorsia will issue up to 27.5 million shares and up to 25.5 million warrants. When complete, the tailored solution secures future operations of Idorsia into 2026. More information can be found in the dedicated press release. Capital increaseIn connection with the holistic restructuring of the convertible bond debt and raising of additional funds, 35 million registered shares with a nominal value of CHF 0.05 each were created out of capital band and were listed on March 4, 2025. Financial guidance for 2025As previously announced, for the Idorsia-led portfolio in 2025, the company expects a continued acceleration of QUVIVIQ with net sales of around CHF 110 million, COGS of around CHF 15 million, SG&A expenses of around CHF 210 million, and R&D expense of around CHF 100 million, leading to non-GAAP operating expenses of around CHF 325 million. This performance would result in an Idorsia-led business non-GAAP operating loss of around CHF 215 million and US-GAAP operating loss of around CHF 260 million. The company expects US-GAAP EBIT for the partnered business of around CHF 135 million – updated to reflect the positive impact of the one-off exclusivity fee paid by an undisclosed party in Q4 2024 but recognized in Q1 2025 – and mainly driven by the amended deal with Viatris. This would result in a US-GAAP loss for the global business of around CHF 125 million. All amounts exclude unforeseen events and potential revenue related to additional business development activities. Arno Groenewoud, Chief Financial Officer, commented:“The updated agreement with Viatris, and the convertible debt restructuring, together with the new money facility agreed with our bondholders, has significantly changed the financial situation of Idorsia. That said, there are still several steps to implement in order to realize what was agreed. The restructuring of the bonds is moving forward with the first step approved by the court, allowing us to proceed to the next bondholder meetings. We are also making progress with putting the new money facility in place. The excellent uplift with QUVIVIQ in Europe and the tight cost-control means we are well on track with our financial performance targets.” Liquidity and indebtednessAt the end of the first quarter of 2025, Idorsia’s liquidity amounted to CHF 51 million. (in CHF millions) Mar 31, 2025Dec 31, 2024Liquidity Cash and cash equivalents 51106Total liquidity* 51106 Indebtedness Convertible loan 335335Convertible bond 797797Other financial debt 190189Total indebtedness 1,3221,321 *rounding differences may occur Commercial operationsIn the first quarter of 2025, QUVIVIQ™ (daridorexant) in the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, France, and Sweden generated total product sales of CHF 25 million. Europe and Canada ProductMechanism of actionIndicationCommercially availableDual orexin receptor antagonistTreatment of adult patients with insomnia characterised by symptoms present for at least three months and considerable impact on daytime functioningSweden: Sept. 2024France: Mar. 2024Austria: Feb. 2024UK: Oct. 2023Spain: Sept. 2023Switzerland: Jun. 2023Germany: Nov. 2022Italy: Nov. 2022 Management of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceCanada: Nov. 2023 QUVIVIQ (daridorexant) net sales in the first quarter of 2025 reached CHF 19.4 million in the Europe and Canada (EUCAN) region, a significant increase from CHF 3.5 million in the first quarter of 2024. In France, QUVIVIQ is reimbursed for moderate and severe chronic insomnia patients after, or as an alternative to, cognitive behavioral therapy for insomnia. The outstanding launch in France is driven by a combination of co-promotion with Menarini reflected by a new-to-brand share growing from 1.1% in September 2024 to 9.3% in January 2025 in the general practitioner (GP) segment, and a strong positioning to specialists in retail and hospital settings reflected by a solid new-to-brand share evolution from 9.7% in September 2024 to 14.4% in January 2025 in the psychiatrist segment. In Germany, QUVIVIQ was launched in November 2022 and is the only sleep medication in Germany that can be prescribed for long-term treatment of chronic insomnia. The progress made in Germany is reflected by the performance of QUVIVIQ on the market, with demand increasing by 20% quarter on quarter. In February 2025, Idorsia successfully concluded negotiations for the reimbursement price in Germany. Idorsia is expanding its commercial reach from specialist prescribers to GPs through a commercial partnership with Berlin-Chemie (a wholly owned subsidiary of the Menarini Group), which started in April 2025. In the UK, QUVIVIQ is recommended as first-line pharmaceutical treatment for patients with chronic insomnia, after, or as an alternative to, cognitive behavioral therapy for insomnia (CBT-I). QUVIVIQ was launched in October 2023 at NICE approval. The priority in the UK in 2024 was to secure regional access, and the team has achieved reimbursement throughout 85% of the UK, as well as raising awareness of QUVIVIQ among general practitioners. Increased access and awareness have started to translate into strong demand in the UK which grew by 48% from Q4 2024 to Q1 2025. In Canada, after being approved in April 2023, QUVIVIQ was launched in November 2023 to the private market, representing 55% of the Canadian insomnia market. To date, 85% of private Canadian lives are covered. The focus is now on public payers; the company submitted public reimbursement dossiers and expects decisions by the end of 2025. QUVIVIQ demand in Canada grew by 25% from Q4 2024 to Q1 2025. Austria will soon become the fourth EUCAN country to grant public reimbursement to QUVIVIQ, starting from June 1, 2025. This is a significant achievement in a country that has strict reimbursement rules and underpins the value QUVIVIQ brings to patients, physicians and the healthcare system. In Italy, QUVIVIQ is now officially available for all prescribers, following its publication in the Official Gazette in mid-March 2025, this includes GPs who represent nearly 80% of the total insomnia market. In Switzerland, Spain, and Sweden, where we are still negotiating for reimbursement, launches have been very successful despite the out-of-pocket costs for patients, particularly in Switzerland where we see a strong demand. Benjamin Limal, President of Europe and Canada region, commented:“Demand has grown by an impressive 50% quarter on quarter, mainly driven by reimbursed markets. Across Europe and Canada, more than 10 million nights of sleep have been prescribed in the first quarter of 2025. Recent successes in access and pricing, notably in Austria and Germany, reinforce our confidence for continued growth moving forward. QUVIVIQ has been strongly adopted by specialists and more and more general practitioners start prescribing QUVIVIQ due to our increased efforts with recent partnerships for the GP market.” For more information about QUVIVIQ in the EU, see the Summary of Product Characteristics. For more information about QUVIVIQ in Switzerland, see the Patient Information and Information for Healthcare Professionals. For more information on the marketing authorization of QUVIVIQ in Canada, see the Product Monograph. United States ProductMechanism of actionIndicationCommercially available sinceDual orexin receptor antagonistTreatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenanceMay 2022 QUVIVIQ® (daridorexant) net sales in the first quarter of 2025 amounted to CHF 5.9 million in the US, compared to CHF 6.5 million in the first quarter of 2024. As of the end of the first quarter of 2025, more than 180,000 patients have been treated with QUVIVIQ since launch in the US, over 600,000 prescriptions have been dispensed, and the product has been prescribed by more than 50,000 healthcare professionals. Michael Moye, President and General Manager of Idorsia US, commented:“We have implemented a streamlined, focused, and more cost-efficient commercialization approach for QUVIVIQ to maintain sales until the potential descheduling of the dual orexin receptor antagonist (DORA) class can be achieved. Our commercialization partner, Syneos Health, is fully operational and executing a highly targeted digital marketing plan supporting 20 virtual sales reps. Syneos is now also executing educational programming and market access activities in support of the virtual representatives. We are seeing early, positive prescribing results in key customer areas.” For more information about QUVIVIQ in the US, see the Full Prescribing Information (PI and Medication Guide). ProductMechanism of actionIndicationCommercially available sinceDual endothelin receptor antagonistTreatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugsOctober 2024 On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recommended dosage of TRYVIO is 12.5 mg orally once daily, with or without food. Following the approval, the US team rapidly established the positioning, branding, websites, materials, training and educational platforms, and field sales force and MSL coverage plans. TRYVIO was made available for prescription in October 2024 via Walgreens Specialty Pharmacy. There is ongoing engagement with hypertension experts at major cardiovascular and nephrology congresses and encouraging discussions with payors. In March 2025, the US FDA fully released TRYVIO from its REMS (Risk Evaluation and Mitigation Strategy) requirement to minimize the burden on the healthcare delivery system of complying with the REMS. The US FDA has determined that a REMS is no longer necessary to ensure the benefits of TRYVIO outweigh the risk of embryo-fetal toxicity and that labeling is sufficient for conveying the safety information. As a result, a rapid transition from specialty pharmacy to a wide retail pharmacy distribution model is underway. Funding for a field sales force and promotional activities continues to be dependent on a partnership deal. Michael concluded:“Early prescribing experience in leading US hypertension centers of excellence has been very positive, with prescribers confirming that they are seeing blood pressure reductions, safety and tolerability consistent with the Phase 3 study. The REMS removal and shift toward broad product availability in retail pharmacies has profoundly improved the potential of TRYVIO to reach millions of patients struggling with their hypertension on existing medication regimens.” For more information see the Full Prescribing Information including BOXED Warning (PI and Medication Guide). Research & DevelopmentOur drug discovery engine has produced innovative drugs with the potential to transform the treatment paradigm in multiple therapeutic areas, including CNS, cardiovascular, and immunological disorders, as well as orphan diseases. The company also has a vaccine platform for the discovery and development of glycoconjugate vaccines to prevent infection. The company has focused its drug discovery efforts, reducing the number of active projects in research and development and preparing some for out-licensing. The prioritization has resulted in a portfolio of assets where Idorsia intends to develop to the next inflection point before partnering, or when feasible and appropriate, developing further ourselves. The company expects new lucerastat data from a kidney biopsy sub-study (to the ongoing Phase 3 open-label extension study) in the second quarter of 2025, with further discussions on the regulatory pathway to follow. The results from a Phase 1 study of our Clostridium difficile infection vaccine are also expected in the coming months. The company will need to further prioritize activities in order to reduce costs and the decisions on which assets to advance will be taken based on the data when available and the results of ongoing out-licensing discussions for early-stage assets. In March 2025, “A randomized cross-over trial of daridorexant for the treatment of chronic insomnia and nocturia” was published in the Journal of Sleep Research. The new data provides evidence of the benefit of daridorexant, at a daily dose of 50 mg, in patients aged >=55 years with chronic insomnia and comorbid nocturia, with efficacy data on symptoms of both conditions, improvement in daytime functioning, and a good safety and tolerability profile. In April 2025, the “Effect of daridorexant on nighttime wakefulness and next-morning sleepiness: assessing the transition from night to day in insomnia disorder” was published in Sleep Medicine. The analysis of the Phase 3 data provides evidence that daridorexant reduces wakefulness throughout the entire night, while decreasing morning sleepiness and improving daytime functioning and alertness in patients with chronic insomnia disorder. Idorsia-led portfolioThe company will develop each asset to the next inflection point or seek a partner. CompoundMechanism of actionTarget indicationStatusQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaCommercialized by Idorsia in the US, Germany, Italy, Switzerland, Spain, the UK, Canada, Austria, France, and Sweden; approved throughout the EU.LucerastatGlucosylceramide synthase inhibitorFabry diseasePhase 3 open-label extension study ongoing – kidney biopsy sub-study results expected in Q2 2025 – regulatory pathway to be further discussed with FDA.DaridorexantDual orexin receptor antagonistPediatric insomniaPhase 2 in pediatric insomnia is ongoing.ACT-777991CXCR3 receptor antagonistVitiligoProof-of-concept study in preparation for patients with vitiligo. Unique precision medicine with a dual targeting of CD8+ CXCR3+ T cells offers potential for a first-in-class targeted systemic therapy for effective and safer treatment of immuno-dermatology and autoimmune disorders.ACT-1004-1239ACKR3 (CXCR7) receptor antagonistProgressive multiple sclerosis Proof-of-concept study in preparation for patients with progressive MS. Unique combination of re-myelination and anti-inflammatory effect with decreased inflammatory cell infiltration.IDOR-1117-2520CCR6 receptor antagonistPsoriasisProof-of-concept study in preparation for patients with psoriasis. Unique potential as a first-in-class, oral, targeted systemic therapy for effective treatment of Th17-driven immuno-dermatology and autoimmune disorders.ACT-1016-0707LPA 1 receptor antagonistImmune-mediated and fibrosis related disordersEntry-into-human package complete. Potential best-in-class due to insurmountable binding mode – proven inhibitory activity in preclinical models of inflammation and fibrosis.IDOR-1134-9712CFTR Type-IV correctorCystic FibrosisEntry-into-human package in progress. A unique corrector targeting an Idorsia-identified binding site on the Cystic Fibrosis Transmembrane regulator (CFTR) protein. Potential synergy with other molecules.IDOR-1141-8472Orexin 2 receptor agonistOrexin-related CNS disordersEntry-into-human package ready to begin. Potential best-in-class – sustained chronic efficacy in a preclinical model of narcolepsy.IDOR-1126-6421Undisclosed mechanismOrgan injury / fibrosisEntry-into-human package in progress. Broad potential of undisclosed mechanism for inhibiting organ injury and fibrosis – proven effectiveness in several preclinical models of organ injury. Synthetic Glycan Vaccine PlatformIdorsia will seek a partner for the platform or individual vaccines.IDOR-1134-2831Synthetic glycan vaccineClostridium difficile infectionIdorsia is conducting a Phase 1 clinical pharmacology study which will test the immune response of the vaccine and evaluate its safety and tolerability. Results expected in Q2 2025.IDOR-1142-0810Synthetic glycan vaccineKlebsiella pneumonia infection Entry-into-human package in progress. Further details including the current status of each project in our portfolio can be found in our innovation fact sheet.Idorsia partner-led portfolioFor Idorsia, partnerships are a way of gaining strategic access to technologies or products and fully exploiting our discovery engine and clinical pipeline. We seek suitable external project partners to maximize the value of internal innovation. On March 19, 2024, the US Food and Drug Administration (FDA) approved TRYVIO™ (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs. See the commercial operations section above. On June 27, 2024, the European Commission (EC) approved JERAYGO™ (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products. The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control. For more information about JERAYGO in the EU, see the Summary of Product Characteristics. Aprocitentan is an innovative and highly differentiated drug, commercially available in the US and approved in Europe and UK for the millions of patients who are unable to bring their hypertension under control with existing medications. As the first drug to target the endothelin pathway in systemic hypertension, aprocitentan has blockbuster potential in uncontrolled hypertension, particularly for difficult to treat patients with chronic kidney disease and hypertension, and further potential beyond hypertension. The priority remains to partner aprocitentan, having been released from the exclusivity constraint with the undisclosed party, the company will resume discussions with alternative potential partners that recognize the value of aprocitentan. In April 2025, “Aprocitentan for Blood Pressure Reduction in Black Patients” was published in Hypertension. The publication reports preplanned analyses of the efficacy, tolerability and safety of aprocitentan in the subgroup of African American patients enrolled in the Phase 3 PRECISION study in patients with confirmed resistant hypertension. Aprocitentan, when added to a combination of at least three antihypertensive drugs (four in more than 50% of patients), produced clinically meaningful and sustained blood pressure reductions. Aprocitentan also markedly decreased proteinuria in the patients with proteinuria at baseline. As reported by the authors, aprocitentan was safe and well tolerated, even in those Black patients with chronic kidney disease. CompoundMechanism of actionTarget indicationPartner/statusTRYVIO™ (aprocitentan) Dual endothelin receptor antagonistSystemic hypertension in combination with other antihypertensivesTo be defined: worldwide development and commercialization rightsCommercially available in the USJERAYGO™ (aprocitentan)Dual endothelin receptor antagonistResistant hypertension in combination with other antihypertensivesTo be defined: worldwide development and commercialization rights Approved in the EU and UK; Marketing authorization applications under review in Canada, and SwitzerlandQUVIVIQ™ (daridorexant)Dual orexin receptor antagonistInsomniaNxera Pharma: license to develop and commercialize for Asia-Pacific region (excluding China)Launched for the treatment of insomnia in Japan; Phase 3 ongoing in South KoreaDaridorexantDual orexin receptor antagonistInsomniaSimcere: license to develop and commercialize for Greater China regionNDA submitted in Greater China; approved for the treatment of insomnia in Hong-KongSelatogrelP2Y12 inhibitorAcute myocardial infarctionViatris: worldwide development and commercialization rightsPhase 3 “SOS-AMI” program ongoingCenerimodS1P1 receptor modulatorSystemic lupus erythematosusViatris: worldwide development and commercialization rightsPhase 3 “OPUS” program ongoingDaridorexantDual orexin receptor antagonistPosttraumatic stress disorder (PTSD)US Department of Defense (DOD): Idorsia is supporting a clinical study sponsored by the US DOD to develop new therapies to treat PTSDACT-1002-4391EP2/EP4 receptor antagonistImmuno-oncologyOwkin: global license to develop and commercializePhase 1 ongoing Further details including the current status of each project in our partner-led portfolio can be found in our innovation fact sheet. Note to ShareholdersThe Annual General Meeting (AGM) of Shareholders to approve the Annual Report of the year ending December 31, 2024, will be held on Wednesday, May 28, 2025. In order to attend and vote at the AGM, shareholders must be registered in the company’s shareholder register by May 19, 2025, 17:00 CEST, at the latest. Results Day CenterInvestor community: To make your job easier, we provide all relevant documentation via the Results Day Center on our corporate website: www.idorsia.com/results-day-center. Events Annual General Meeting of Shareholders on May 28, 2025Half-Year 2025 Financial Results reporting on July 30, 20259-Month 2025 Financial Results reporting on October 30, 2025 Notes to the editor About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 10 investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
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MIAMI, April 25, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced that it will release its first quarter 2025 financial results on Friday, May 9, 2025. In conjunction with the release, InspireMD will host a conference call and webcast at 8:30 a.m. Eastern Time to discuss its financial results and recent highlights.
CVRx to Report First Quarter 2025 Financial and Operating Results and Host Conference Call on May 8, 2025
MINNEAPOLIS, April 24, 2025 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced that it plans to release first quarter 2025 financial and operating results after market close on Thursday, May 8, 2025. The Company will host a conference call to review its results at 4:30pm Eastern Time the same day. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-800-445-7795 for U.S. callers, or 1-785-424-1699 for international callers, approximately ten minutes prior to the start time. Please reference the following conference ID to access the call: CVRXQ125. About CVRx, Inc. CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact:Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
Merit Medical Reports First Quarter 2025 Results and Updates Full-Year Guidance
First Quarter Highlights† Reported revenue of $355.4 million, up 9.8%Constant currency revenue* and constant currency revenue, organic* up 10.9% and up 6.0%, respectivelyGAAP operating margin of 11.5%, compared to 11.1% in prior year periodNon-GAAP operating margin* of 19.3%, compared to 17.0% in prior year periodGAAP EPS $0.49, up 2.0%Non-GAAP EPS* $0.86, up 14.8%Free cash flow* generation of $19.5 million, down 20.5% † Comparisons above are calculated for the current quarter compared with the first quarter of 2024, unless otherwise specified. Amounts stated in this release are rounded, while percentages are calculated from the underlying amounts. * Constant currency revenue; constant currency revenue, organic; non-GAAP gross profit and margin; non-GAAP operating income and margin; non-GAAP net income; non-GAAP EPS; and free cash flow figures (used here and below) are non-GAAP financial measures. A reconciliation of these financial measures to their most directly comparable GAAP financial measures is included under the heading “Non-GAAP Financial Measures” below. SOUTH JORDAN, Utah, April 24, 2025 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced revenue of $355.4 million for the quarter ended March 31, 2025, an increase of 9.8% compared to the quarter ended March 31, 2024. Constant currency revenue for the first quarter of 2025 increased 10.9% compared to the prior year period and constant currency revenue, organic, for the first quarter of 2025 increased 6.0% compared to the prior year period. “We delivered better-than-expected financial performance in the first quarter, with our constant currency revenue, organic, our constant currency total revenue and our non-GAAP EPS exceeding the high-end of our expectations,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “We also delivered impressive year-over-year improvements in our non-GAAP operating margin and our non-GAAP earnings per share, which increased 229 basis points and 15%, respectively, year-over-year.” Mr. Lampropoulos continued: “We have reaffirmed our 2025 total revenue guidance, which reflects continued confidence in our team’s ability to deliver strong execution and stable constant currency growth this year. We have updated our 2025 non-GAAP earnings per share guidance to reflect our stronger-than-expected first quarter results, offset by the currently projected impact of recently implemented trade policies and related actions by the U.S. and other countries.” Merit’s revenue by operating segment and product category for the three-month periods ended March 31, 2025 and 2024 was as follows (unaudited; in thousands, except for percentages): Three Months Ended Reported Constant Currency* March 31, Impact of foreign March 31, 2025 2024(1) % Change exchange 2025 % ChangeCardiovascular Peripheral Intervention$137,279 $130,066 5.5 % $1,665 $138,944 6.8 %Cardiac Intervention 99,741 90,176 10.6 % 1,233 100,974 12.0 %Custom Procedural Solutions 47,942 48,523 (1.2)% 412 48,354 (0.3)%OEM 53,751 44,609 20.5 % 71 53,822 20.7 %Total 338,713 313,374 8.1 % 3,381 342,094 9.2 % Endoscopy Endoscopy Devices 16,638 10,134 64.2 % 24 16,662 64.4 % Total$355,351 $323,508 9.8 % $3,405 $358,756 10.9 % (1)Commencing January 1, 2025, we reorganized our sales teams and product categories to include the sale of our spine devices under our OEM product categories. Revenue figures for 2024 have been recast to reflect the realignment of Merit’s portfolio of spine products, representing approximately $5.3 million in revenue, within the OEM product category to provide comparability between the reported periods. Merit’s GAAP gross margin for the first quarter of 2025 was 48.4%, compared to GAAP gross margin of 46.9% for the first quarter of 2024. Merit’s non-GAAP gross margin* for the first quarter of 2025 was 53.4%, compared to non-GAAP gross margin* of 50.9% for the first quarter of 2024. Merit’s GAAP net income for the first quarter of 2025 was $30.1 million, or $0.49 per share, compared to GAAP net income of $28.2 million, or $0.48 per share, for the first quarter of 2024. Merit’s non-GAAP net income* for the first quarter of 2025 was $52.9 million, or $0.86 per share, compared to non-GAAP net income* of $44.1 million, or $0.75 per share, for the first quarter of 2024. As of March 31, 2025, Merit had cash and cash equivalents of $395.5 million and total debt obligations of $747.5 million, compared to cash and cash equivalents of $376.7 million and total debt obligations of $747.5 million as of December 31, 2024. Merit had available borrowing capacity of approximately $697 million as of March 31, 2025. Fiscal Year 2025 Financial Guidance Based upon the information currently available to Merit’s management, for the year ending December 31, 2025, absent the potential impact of trade policies and related actions implemented by the U.S. and other countries subsequent to today’s date, material acquisitions, non-recurring transactions or other factors beyond Merit’s current expectations, Merit anticipates the following financial results: Revenue and Earnings Guidance* Updated GuidancePrior Guidance(2)Financial MeasureYear Ending% ChangeYear Ending% Change December 31, 2025Y/YDecember 31, 2025Y/Y Net Sales$1.470 – $1.490 billion8% – 10%$1.470 – $1.490 billion8% – 10%Cardiovascular Segment$1.397 – $1.415 billion7% – 9%$1.395 – $1.413 billion7% – 9%Endoscopy Segment$73.0 – $75.0 million34% – 37%$74.6 – $76.7 million36% – 40% Non-GAAP Earnings Per Share(1)$3.29 – $3.42(5%) – (1%)$3.58 – $3.704% – 7% *Percentage figures approximated; dollar figures may not foot due to rounding(1) Merit’s non-GAAP earnings per share reflect the dilutive impact of its 3.00% Convertible Senior Notes due 2029 (the “Convertible Notes”) calculated using the if-converted method of approximately $0.05 for the year ending December 31, 2025. Any offsetting impacts of the capped call associated with the Convertible Notes are not considered(2) “Prior Guidance” reflects Merit’s full-year 2025 financial guidance, previously introduced on February 25, 2025. 2025 Net Sales Guidance – % Change from Prior Year (Constant Currency) Reconciliation* Updated Guidance Prior Guidance(1) Low High Low High2025 Net Sales Guidance – % Change from Prior Year (GAAP)8.4% 9.8% 8.4% 9.8%Estimated impact of foreign currency exchange rate fluctuations0.4% 0.4% 0.2% 0.2%2025 Net Sales Guidance – % Change from Prior Year (Constant Currency)8.7% 10.2% 8.6% 10.1% *Percentage figures approximated and may not foot due to rounding(1)“Prior Guidance” reflects Merit’s full-year 2025 financial guidance, previously introduced on February 25, 2025. Merit does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures (other than revenue) because Merit is unable to predict with reasonable certainty the financial impact of various items which could impact Merit’s future financial results, such as expenses attributable to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, Merit is unable to address the significance of the unavailable information, which could be material to future results. Specifically, Merit is not, without unreasonable effort, able to reliably predict the impact of these items and Merit believes inclusion of a reconciliation of these forward-looking non-GAAP measures to their GAAP counterparts could be confusing to investors or cause undue reliance. Merit’s financial guidance for the year ending December 31, 2025 is subject to risks and uncertainties identified in this release and Merit’s filings with the U.S. Securities and Exchange Commission (the “SEC”). This guidance is based on information and estimates available to Merit as of April 24, 2025. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results will likely vary, and could vary materially, from past results and those anticipated, estimated or projected. CONFERENCE CALL Merit will hold its investor conference call today, Thursday, April 24, 2025, at 5:00 p.m., Eastern Time. To access the conference call, please pre-register using the following link. Registrants will receive confirmation with dial-in details. A live webcast and slide deck will also be available at merit.com. CONSOLIDATED BALANCE SHEETS(in thousands) March 31, 2025 December 31, (Unaudited) 2024ASSETS Current Assets Cash and cash equivalents$395,529 $376,715 Trade receivables, net 199,550 190,243 Other receivables 17,116 16,588 Inventories 317,936 306,063 Prepaid expenses and other assets 25,007 28,544 Prepaid income taxes 3,417 3,286 Income tax refund receivables 80 2,335 Total current assets 958,635 923,774 Property and equipment, net 390,324 386,165 Intangible assets, net 478,976 498,265 Goodwill 464,360 463,511 Deferred income tax assets 16,100 16,044 Operating lease right-of-use assets 87,722 65,508 Other assets 71,856 65,336 Total Assets$2,467,973 $2,418,603 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities Trade payables$63,759 $68,502 Accrued expenses 118,679 134,077 Current operating lease liabilities 9,435 10,331 Income taxes payable 4,950 3,492 Total current liabilities 196,823 216,402 Long-term debt 730,673 729,551 Deferred income tax liabilities 247 240 Liabilities related to unrecognized tax benefits 2,118 2,118 Deferred compensation payable 18,617 19,197 Deferred credits 1,476 1,502 Long-term operating lease liabilities 77,549 54,783 Other long-term obligations 12,047 15,451 Total liabilities 1,039,550 1,039,244 Stockholders’ Equity Common stock 718,111 703,219 Retained earnings 725,688 695,541 Accumulated other comprehensive loss (15,376) (19,401)Total stockholders’ equity 1,428,423 1,379,359 Total Liabilities and Stockholders’ Equity$2,467,973 $2,418,603 CONSOLIDATED STATEMENTS OF INCOME(Unaudited, in thousands except per share amounts) Three Months Ended March 31, 2025 2024Net sales$355,351 $323,508 Cost of sales 183,331 171,793 Gross profit 172,020 151,715 Operating expenses: Selling, general and administrative 107,486 94,428 Research and development 22,478 21,482 Contingent consideration expense (benefit) 1,023 (117)Total operating expenses 130,987 115,793 Income from operations 41,033 35,922 Other income (expense): Interest income 3,790 7,276 Interest expense (6,568) (8,046)Other expense — net (297) (804)Total other expense — net (3,075) (1,574) Income before income taxes 37,958 34,348 Income tax expense 7,811 6,108 Net income$30,147 $28,240 Earnings per common share Basic$0.51 $0.49 Diluted$0.49 $0.48 Weighted average shares outstanding Basic 58,897 57,958 Diluted 61,278 58,567 CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited, in thousands) Three Months Ended March 31, 2025 2024CASH FLOWS FROM OPERATING ACTIVITIES: Net income$30,147 $28,240 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 29,292 23,599 Write-off of certain intangible assets and other long-term assets 32 202 Amortization of right-of-use operating lease assets 2,984 3,122 Fair value adjustments related to contingent consideration liabilities 1,023 (117)Stock-based compensation expense 9,078 5,234 Other adjustments 1,475 1,486 Changes in operating assets and liabilities, net of acquisitions (33,459) (25,550)Total adjustments 10,425 7,976 Net cash, cash equivalents, and restricted cash provided by operating activities 40,572 36,216 CASH FLOWS FROM INVESTING ACTIVITIES: Capital expenditures for property and equipment (21,061) (11,682)Cash paid for notes receivable and other investments (7,117) (6,508)Cash paid in acquisitions, net of cash acquired (1,000) (3,000)Other investing, net (457) (861)Net cash, cash equivalents, and restricted cash used in investing activities (29,635) (22,051) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of common stock 13,152 7,730 Proceeds from (payments on) long-term debt — (24,063)Contingent payments related to acquisitions (52) (78)Payment of taxes related to an exchange of common stock (6,145) (1,592)Net cash, cash equivalents, and restricted cash provided by (used in) financing activities 6,955 (18,003)Effect of exchange rates on cash 936 (1,319)Net increase (decrease) in cash, cash equivalents and restricted cash 18,828 (5,157) CASH, CASH EQUIVALENTS AND RESTRICTED CASH: Beginning of period 378,767 589,144 End of period$397,595 $583,987 RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH TO THE CONSOLIDATED BALANCE SHEETS: Cash and cash equivalents 395,529 581,921 Restricted cash reported in prepaid expenses and other current assets 2,066 2,066 Total cash, cash equivalents and restricted cash$397,595 $583,987 Non-GAAP Financial Measures Although Merit’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”), Merit’s management believes that the non-GAAP financial measures referenced in this release may provide investors with useful information regarding the underlying business trends and performance of Merit’s ongoing operations and can be useful for period-over-period comparisons of such operations. Non-GAAP financial measures used in this release include: constant currency revenue;constant currency revenue, organic;non-GAAP gross profit and margin;non-GAAP operating income and margin;non-GAAP net income;non-GAAP earnings per share; andfree cash flow. Merit’s management team uses these non-GAAP financial measures to evaluate Merit’s profitability and efficiency, to compare operating and financial results to prior periods, to evaluate changes in the results of its operating segments, and to measure and allocate financial resources internally. However, Merit’s management does not consider such non-GAAP measures in isolation or as an alternative to measures determined in accordance with GAAP. Readers should consider non-GAAP measures used in this release in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. These non-GAAP financial measures generally exclude some, but not all, items that may affect Merit’s net income. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. Merit believes it is useful to exclude such items in the calculation of non-GAAP gross profit and margin, non-GAAP operating income and margin, non-GAAP net income, and non-GAAP earnings per share (in each case, as further illustrated in the reconciliation tables below) because such amounts in any specific period may not directly correlate to the underlying performance of Merit’s business operations and can vary significantly between periods as a result of factors such as acquisition or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings or changes in tax or industry regulations, gains or losses on disposal of certain assets, and debt issuance costs. Merit may incur similar types of expenses in the future, and the non-GAAP financial information included in this release should not be viewed as a statement or indication that these types of expenses will not recur. Additionally, the non-GAAP financial measures used in this release may not be comparable with similarly titled measures of other companies. Merit urges readers to review the reconciliations of its non-GAAP financial measures to their most directly comparable GAAP financial measures included herein, and not to rely on any single financial measure to evaluate Merit’s business or results of operations. Constant Currency Revenue Merit’s constant currency revenue is prepared by converting the current-period reported revenue of subsidiaries whose functional currency is a currency other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period and adjusting for the effects of hedging transactions on reported revenue, which are recorded in the U.S. dollar. The constant currency revenue adjustment of $3.4 million to reported revenue for the three-month period ended March 31, 2025, was calculated using the applicable average foreign exchange rates for the three-month period ended March 31, 2024. Constant Currency Revenue, Organic Merit’s constant currency revenue, organic, is defined, with respect to prior fiscal year periods, as GAAP revenue. With respect to current fiscal year periods, constant currency revenue, organic, is defined as constant currency revenue (as defined above), less revenue from certain acquisitions. For the three-month period ended March 31, 2025, Merit’s constant currency revenue, organic, excludes revenues attributable to (i) the assets acquired from Cook Medical Holdings, LLC (“Cook Medical”) in November 2024 and (ii) the assets acquired from EndoGastric Solutions, Inc. (“EGS”) in July 2024. Non-GAAP Gross Profit and Margin Non-GAAP gross profit is calculated by reducing GAAP cost of sales by amounts recorded for amortization of intangible assets. Non-GAAP gross margin is calculated by dividing non-GAAP gross profit by reported net sales. Non-GAAP Operating Income and Margin Non-GAAP operating income is calculated by adjusting GAAP operating income for certain items which are deemed by Merit’s management to be outside of core operations and vary in amount and frequency among periods, such as expenses related to acquisitions or other extraordinary transactions, non-cash expenses related to amortization or write-off of previously acquired tangible and intangible assets, certain employee termination benefits, performance-based stock compensation expenses, expenses resulting from non-ordinary course litigation or administrative proceedings and resulting settlements, governmental proceedings, and changes in governmental or industry regulations, as well as other items referenced in the tables below. Non-GAAP operating margin is calculated by dividing non-GAAP operating income by reported net sales. Non-GAAP Net Income Non-GAAP net income is calculated by adjusting GAAP net income for the items set forth in the definition of non-GAAP operating income above, as well as for expenses related to debt issuance costs and other items set forth in the tables below. Non-GAAP EPS Non-GAAP EPS is defined as non-GAAP net income divided by the diluted shares outstanding for the corresponding period. Free Cash Flow Free cash flow is defined as cash flow from operations calculated in accordance with GAAP, less capital expenditures for property and equipment calculated in accordance with GAAP, as set forth in the consolidated statement of cash flows. Non-GAAP Financial Measure Reconciliations The following tables set forth supplemental financial data and corresponding reconciliations of non-GAAP financial measures to Merit’s corresponding financial measures prepared in accordance with GAAP, in each case, for the three-month periods ended March 31, 2025 and 2024. The non-GAAP income adjustments referenced in the following tables do not reflect non-performance-based stock compensation expense of $4.3 million and $3.1 million for the three-month periods ended March 31, 2025 and 2024, respectively. Reconciliation of GAAP Net Income to Non-GAAP Net Income(Unaudited, in thousands except per share amounts) Three Months Ended March 31, 2025 Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$37,958 $(7,811) $30,147 $0.49 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 17,606 (4,160) 13,446 0.22 Operating Expenses Contingent consideration expense 1,023 9 1,032 0.02 Amortization of intangibles 2,394 (566) 1,828 0.03 Performance-based share-based compensation (b) 4,774 (586) 4,188 0.07 Acquisition-related 16 (4) 12 0.00 Medical Device Regulation expenses (c) 1,594 (377) 1,217 0.02 Other (d) (21) 5 (16) (0.00)Other (Income) Expense Amortization of long-term debt issuance costs 1,414 (334) 1,080 0.02 Non-GAAP net income$66,758 $(13,824) $52,934 $0.86 Diluted shares 61,278 Three Months Ended March 31, 2024 (a) Pre-Tax Tax Impact After-Tax Per Share ImpactGAAP net income$34,348 $(6,108) $28,240 $0.48 Non-GAAP adjustments: Cost of Sales Amortization of intangibles 12,805 (3,028) 9,777 0.17 Operating Expenses Contingent consideration benefit (117) 47 (70) (0.00)Amortization of intangibles 1,764 (417) 1,347 0.02 Performance-based share-based compensation (b) 2,128 (294) 1,834 0.03 Acquisition-related 38 (9) 29 0.00 Medical Device Regulation expenses (c) 2,207 (521) 1,686 0.03 Other (d) 122 (30) 92 0.00 Other (Income) Expense Amortization of long-term debt issuance costs 1,477 (348) 1,129 0.02 Non-GAAP net income$54,772 $(10,708) $44,064 $0.75 Diluted shares 58,567 _____________________________ Note: Certain per-share impacts may not sum to totals due to rounding. Reconciliation of Reported Operating Income to Non-GAAP Operating Income(Unaudited, in thousands except percentages) Three Months Ended Three Months Ended March 31, 2025 March 31, 2024 (a) Amounts % Sales Amounts % SalesNet Sales as Reported$355,351 $323,508 GAAP Operating Income 41,033 11.5 % 35,922 11.1 %Cost of Sales Amortization of intangibles 17,606 5.0 % 12,805 4.0 %Operating Expenses Contingent consideration expense (benefit) 1,023 0.3 % (117) (0.0)%Amortization of intangibles 2,394 0.7 % 1,764 0.5 %Performance-based share-based compensation (b) 4,774 1.3 % 2,128 0.7 %Acquisition-related 16 0.0 % 38 0.0 %Medical Device Regulation expenses (c) 1,594 0.4 % 2,207 0.7 %Other (d) (21) (0.0)% 122 0.0 % Non-GAAP Operating Income$68,419 19.3 % $54,869 17.0 % _____________________________ Note: Certain percentages may not sum to totals due to rounding. (a)Beginning in the second quarter of 2024, consulting expenses associated with initiatives conducted under Merit’s Foundations for Growth Program (“FFG Program”) have not been adjusted as part of its non-GAAP financial measures. As a result, Merit’s non-GAAP financial measures for prior periods have been recast for comparability. For the three-month period ended March 31, 2024, Merit’s non-GAAP financial measures have been updated to no longer adjust $1.0 million for consulting fees under its FFG Program and the related income tax effect. (b)Represents performance-based share-based compensation expense, including stock-settled and cash-settled awards. (c)Represents incremental expenses incurred to comply with the E.U. Medical Device Regulation. (d)Represents costs to comply with Merit’s corporate integrity agreement with the U.S. Department of Justice (the “DOJ”). Reconciliation of Reported Revenue to Constant Currency Revenue (Non-GAAP), and Constant Currency Revenue, Organic (Non-GAAP) (Unaudited, in thousands except percentages) Three Months Ended March31, % Change 2025 2024Reported Revenue9.8% $355,351 $323,508 Add: Impact of foreign exchange 3,405 — Constant Currency Revenue (a)10.9% $358,756 $323,508 Less: Revenue from certain acquisitions (15,789) — Constant Currency Revenue, Organic (a)6.0% $342,967 $323,508 _____________________________ (a)A non-GAAP financial measure. For a definition of this and other non-GAAP financial measures, see the section of this release entitled “Non-GAAP Financial Measures.” Reconciliation of Reported Gross Margin to Non-GAAP Gross Margin (Non-GAAP) (Unaudited, as a percentage of reported revenue) Three Months Ended March 31, 2025 2024 Reported Gross Margin48.4% 46.9% Add back impact of: Amortization of intangibles5.0% 4.0% Non-GAAP Gross Margin53.4% 50.9% _____________________________ Note: Certain percentages may not sum to totals due to rounding. ABOUT MERIT Founded in 1987, Merit is engaged in the development, manufacture, and distribution of proprietary medical devices used in interventional, diagnostic, and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care, and endoscopy. Merit serves customers worldwide with a domestic and international sales force and clinical support team totaling more than 800 individuals. Merit employs approximately 7,300 people worldwide. CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among others: statements proceeded or followed by, or that include the words, “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” “seeks,” “believes,” “estimates,” “projects,” “forecasts,” “potential,” “target,” “continue,” “upcoming,” “optimistic” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology;statements that address Merit’s future operating performance or events or developments that Merit’s management expects or anticipates will occur, including, without limitation, any statements regarding Merit’s projected revenues, earnings or other financial measures, Merit’s plans and objectives for future operations, Merit’s proposed new products or services, the integration, development or commercialization of the business or any assets acquired from other parties, future economic conditions or performance, the implementation of, and results which may be achieved through, Merit’s Continued Growth Initiatives Program or other business optimization initiatives, and any statements of assumptions underlying any of the foregoing; andstatements regarding Merit’s past performance, efforts, or results about which inferences or assumptions may be made, including statements proceeded or followed by the words “preliminary,” “initial,” “potential,” “possible,” “diligence,” “industry-leading,” “compliant,” “indications,” or “early feedback” or other forms of these words or similar words or expressions, or the negative thereof or other comparable terminology. The forward-looking statements contained in this release are based on Merit management’s current expectations and assumptions regarding future events or outcomes. If underlying expectations or assumptions prove inaccurate, or risks or uncertainties materialize, actual results will likely differ, and could differ materially, from Merit’s expectations reflected in any forward-looking statements. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Investors are cautioned not to unduly rely on any such forward-looking statements. The following are some of the important risks and uncertainties that could cause Merit’s actual results to differ from Merit’s expectations in any forward-looking statements: risks and uncertainties regarding trade policies or related actions implemented by the U.S. or other countries, including existing, proposed or prospective tariffs, duties or other measures; inherent risks and uncertainties associated with Merit’s integration of businesses or assets acquired from third parties, including the businesses and assets acquired from Cook Medical in November 2024 and EGS in July 2024, and Merit’s ability to achieve the anticipated operating and financial results, product development and other anticipated benefits of such acquisitions; effects of the Convertible Notes on Merit’s net income and earnings per share performance; disruptions in Merit’s supply chain, manufacturing or sterilization processes; U.S. and global political, economic, competitive, reimbursement and regulatory conditions; reduced availability of, and price increases associated with, components and other raw materials; increases in transportation expenses; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; fluctuations in interest or foreign currency exchange rates and inflation; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; difficulties relating to development, testing and regulatory approval, clearance and maintenance of Merit’s products; the safety, efficacy and patient and physician adoption of Merit’s products; uncertainties regarding enrollment and outcomes of ongoing and future clinical trials and market studies relating to Merit’s products; modification or limitation of governmental or private insurance reimbursement policies; litigation and other judicial proceedings affecting Merit; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S Foreign Corrupt Practices Act or other laws or regulations; consequences associated with a Corporate Integrity Agreement executed between Merit and the DOJ; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; product recalls and product liability claims; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other jurisdictions or exposure to additional tax liabilities which may adversely affect Merit’s effective tax rate; termination of relationships with Merit’s suppliers, or failure of such suppliers to perform; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; dependence on distributors to commercialize Merit’s products in various jurisdictions outside the U.S.; failure to comply with applicable environmental laws; changes in key personnel; labor shortages and increases in labor costs; price and product competition; extreme weather events; and geopolitical events. For a further discussion of the risks and uncertainties which may affect Merit’s business, operations and financial condition, see Part I, Item 1A, “Risk Factors” in Merit’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC, Part II, Item 1A, “Risk Factors” in Merit’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 filed with the SEC and Merit’s other filings with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this release are made only as of the date of this release, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements. TRADEMARKS Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc., its subsidiaries, or its licensors. Contacts: PR/Media Inquiries:Sarah Comstock Merit Medical+1-801-432-2864sarah.comstock@merit.comInvestor Inquiries:Mike Piccinino, CFA, IRCICR Healthcare+1-443-213-0509 mike.piccinino@icrhealthcare.com



