Aflibercept-abzv

Basel, 29 April 2026 – Sandoz (SIX: SDZ/OTCQX: SDZNY), the global leader in affordable medicines, today presents its net-sales performance for the first quarter of 2026. Q1 2026 % Q1 2025 Change USD m Net sales USD m USD % CC %1,2,3 Net sales 2,756 100% 2,480 11% 3% Biosimilars 853 31% 671 27% 18% Generics 1,903 69% 1,809 5% -3% Europe 1,556 57% 1,372 13% 2% International 609 22% 590 3% -2% North America 591 21% 518 14% 12% Performance in line with Company expectations. Overall net sales up by 3% at CC, and by 5% when excluding effect of adverse dynamics in anti-infective B2B business4. Impact of dynamics in year concentrated in first quarter, with remaining effects dissipating thereafter Biosimilar net sales up by 18% at CC, with generics net sales declining by 3% at CC. Underlying generics net sales declined by 1% at CC when excluding aforementioned anti-infective B2B impact North America net sales up by 12% at CC, reflecting exceptional biosimilars performance. Europe net sales up by 2% at CC with biosimilars net sales up by double digit. Excluding anti-infective B2B impact, Europe net sales up by 4% at CC. Exceptional International biosimilar net sales, with region’s generics result impacted by active portfolio rationalisation and phasing of sales, as well as anti-infective B2B effect Announcement of strategic partnership with Samsung Bioepis, covering up to five biosimilar assets Full-year 2026 guidance confirmed Richard Saynor, Chief Executive Officer of Sandoz, commented: “The performance in the first quarter illustrates the underlying strengths of Sandoz. I was delighted by the exceptional growth in North America and International across biosimilars, supported by new launches and excellence in execution. We produced sales growth in line with our expectations, and the fundamentals of the 2026 roadmap are strong. We are happy to confirm our full-year guidance today. “As we look further out, I’m excited by the overwhelming scale of the opportunities ahead. We’ll complete the construction of our biosimilar hub soon; we’re rapidly expanding the biosimilar pipeline; regulatory streamlining is an important tailwind, and a very significant number of losses of exclusivity are approaching. More than 20,000 Sandoz colleagues are ready to capitalise on these opportunities and deliver even more for patients and shareholders.” BUSINESS HIGHLIGHTS In March 2026, Sandoz and Samsung Bioepis entered a strategic partnership covering up to five biosimilar assets, with the first being a proposed vedolizumab biosimilar. The agreement expands the Sandoz biosimilar pipeline to up to 32 assets In the period, the Company focused its biosimilar development, manufacturing and supply activities under newly appointed Armin Metzger. This will drive faster decision making, greater vertical integration and improved launch readiness across the expanding biosimilars pipeline. There are no changes to the Company’s financial-reporting structure The European Medicines Agency (EMA) recently confirmed that, for well‑characterised biological medicines, a robust analytical comparability package, combined with comparative pharmacokinetic data, may be sufficient to demonstrate biosimilarity, and comparative clinical efficacy and safety studies are not necessarily required. The EMA commented, “this tailored clinical approach is expected to be applicable for the majority of biosimilar candidates” In March 2026, the US FDA expanded the label for Enzeevu® (aflibercept) to include macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema, along with the previously approved indication of neovascular (wet) age-related macular degeneration. This significantly broadened the treatable patient population and supports a planned Q4 2026 US launch In the period, the European Commission granted marketing authorisation for Ranluspec® (ranibizumab) across all reference indications, reinforcing the Company’s ophthalmology franchise and paving the way for an expected H2 2026 European launch In April2026, following a Commerce Department investigation, the US government confirmed that generic and biosimilar medicines “should not be subject to section 232 tariffs at this time” During the period, the Company announced the issuance of a CHF 275 million bond with a six-year maturity and a CHF 275 million bond with a 10-year maturity, for the refinancing of maturing debt and other general corporate purposes. Sandoz is on track to extend its average debt maturity to six to seven years FULL-YEAR 2026 GUIDANCEThe Company continues to anticipate strong net-sales growth and further core EBITDA-margin expansion this year. As a result, the Company confirms its guidance for 2026: Net sales to grow at CC by a mid-to-high single-digit percentage Core EBITDA-margin expansion of around 100 basis points No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low-to-mid single-digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government. CONFERENCE CALL A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here. NOTES The performance shown in this Media Release covers the three-month period ended 31 March 2026 (Q1 2026), compared to the three-month period ended 31 March 2025 (Q1 2025). In this Media Release, ‘Company’ refers to Sandoz Group AG. Over one billion patients were reached by Sandoz in 2025, including an estimated 0.2 billion patients reached through API sales. CALENDARThe Company intends to publish its half-year results on 5 August 2026.DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialise or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES1 Constant currencies. 2 Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025. 3 For Q1 2026, all growth at constant currencies is the same as the comparable growth rate. Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. 4 As part of its vertically integrated penicillin production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) on a business-to-business (B2B) basis. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6 Aminopenicillanic acid (6 APA), the foundational compound for all penicillin. This price decline coincided with an increase in global market supply. Penicillin API represented a significant part of anti-infective B2B net sales in FY 2025. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alexis Kalomparis +41 79 279 0285 Craig Marks +44 7818 942 383 Chris Lewis +49 174 244 9501 Tamara Hackl +41 79 790 5217 Gregor Rodehueser +49 170 574 3200 Silvia Siegfried +41 79 795 9061 FIRST-QUARTER NET SALES Net sales of USD 2,756 million in the quarter represented growth of 3% at CC. Volumes grew by 7%, partly offset by price erosion of 4%. Net-sales growth was primarily driven by the performance of biosimilars, which continue to benefit from an extensive launch programme. When excluding the impact of adverse dynamics in the anti-infective B2B business, the growth in net sales amounted to 5% at CC. By business Q1 2026 Q1 2026 % Q1 2025 change USD m Net sales USD m USD % CC % CGR % Net sales 2,756 100% 2,480 11% 3% 3% Biosimilars 853 31% 671 27% 18% 18% Generics 1,903 69% 1,809 5% -3% -3% Biosimilars overview Net sales of biosimilars of USD 853 million reflected a strong growth of 18% at CC. Biosimilars represented 31% of total net sales (Q1 2025: 27%). The Europe biosimilars performance benefited from the launch of Afqlir® (aflibercept) and good performances from Hyrimoz® (adalimumab) and Binocrit® (epoetin alfa). Exceptional North America biosimilar net-sales growth reflected the strong launch of Wyost® & Jubbonti® (denosumab), while an exceptional International biosimilar result was driven by the performances of Hyrimoz, Rixathon® (rituximab) and the recent launches of Wyost & Jubbonti. Generics overview Net sales of generics of USD 1,903 million reflected a decline of 3% at CC and, when excluding the impact of adverse dynamics in the anti-infective B2B business, this translated to a decrease of 1% at CC. Generics represented 69% of net sales (Q1 2025: 73%). The decline in net sales was mainly driven by the performance in the International business which was significantly impacted by active portfolio rationalisation and the phasing of sales, as well as the aforementioned anti-infective B2B effect. By region Q1 2026 Q1 2026 % Q1 2025 change USD m Net sales USD m USD % CC % CGR % Net sales 2,756 100% 2,480 11% 3% 3% Europe 1,556 57% 1,372 13% 2% 2% International 609 22% 590 3% -2% -2% North America 591 21% 518 14% 12% 12% Europe overview Net sales in Europe were USD 1,556 million, reflecting growth of 2% at CC, with a double-digit biosimilars performance at CC outweighed by a decline in generics net sales, with the latter impacted by the effect of adverse dynamics in the anti-infective B2B business. This performance was also driven by unfavourable seasonal effects on the sale of antibiotics and over-the-counter cold & cough medicines, alongside the impacts of market dynamics in Germany, price erosion and healthcare-policy changes in France. International overview Net sales in International were USD 609 million, a decline of 2% at CC. Biosimilars delivered an exceptional performance, driven by Hyrimoz, Rixathonand the recent launches of Wyost & Jubbonti. Generics net sales decreased at CC, primarily due to active portfolio rationalisation and the phasing of sales, as well as the impact of adverse dynamics in the anti-infective B2B business. North America overview Net sales in North America were USD 591 million, representing growth of 12% at CC. An exceptional biosimilar result was driven by the strong launches of Wyost & Jubbonti. Generics net-sales growth was driven by recent US launch of lisdexamfetamine and the performance of estradiol. The Company provides the net-sales performance by region by business at each half-year and full-year results. APPENDIX QUARTERLY 2025 NET SALES BY BUSINESS Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Biosimilars 671 8% 11% 825 15% 12% 862 16% 13% 934 21% 16% Generics 1,809 -3% 0% 1,927 5% 2% 1,963 6% 3% 2,095 8% 2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% BY REGION Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,372 3% 7% 1,460 12% 6% 1,530 12% 6% 1,574 15% 6% International 590 -8% -2% 694 11% 11% 659 4% 4% 770 18% 14% North America 518 -1% 1% 598 -4% -3% 636 6% 7% 685 -1% -2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% Investors Media Patients & Caregivers Partners (B2B) Job seekers Suppliers Contacts Our policies Transparency Careers Sandoz Site Directory Report Adverse Event Medical inquiry SpeakUp Email subscription 1 A Pharma Hexal Lek Investors Media Patients & Caregivers Partners (B2B) Job seekers Suppliers Contacts Our policies Transparency Careers Sandoz Site Directory Report Adverse Event Medical inquiry SpeakUp Email subscription 1 A Pharma Hexal Lek

The US FDA approved an extended dosing interval for Eylea HD (aflibercept), allowing Regeneron Pharmaceuticals to label the 8 mg intravitreal injection for dosing intervals of up to five months in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The company said this makes Eylea HD the first injectable anti-VEGF agent with a labelled interval of up to 20 weeks for both conditions, representing a label update to a product originally cleared by the US FDA in August 2023. The April 2026 approval specifically extends the maximum dosing interval beyond the 8-16 week range established at the time of the original approval. Under the updated label, patients with wAMD or DME who have completed one year of treatment may be eligible for the extended schedule. The formulation is a higher-concentration version of the established aflibercept molecule, delivered as an intravitreal injection, and developed in the US by Regeneron under its longstanding ophthalmic collaboration with Bayer, which retains commercialization rights outside the United States. The regulatory decision drew on 96-week data from two randomized, double-masked, non-inferiority pivotal trials: PULSAR, which enrolled patients with wAMD, and PHOTON, which enrolled patients with DME. Both studies compared aflibercept 8 mg against the established 2 mg dose of the same molecule. Published 48-week readouts, available via AllSci and PubMed, showed that visual acuity outcomes with the 8 mg formulation were non-inferior to those with the 2 mg reference dose at that timepoint. The company said the majority of patients in both trials maintained their visual and anatomic improvements when transitioned to extended dosing intervals over the full 96-week period, though the approval announcement did not disclose full 96-week efficacy tables or detailed safety breakdowns.. The approval lands in a retinal treatment field where the frequency of intravitreal injection has been a persistent clinical and practical concern. Anti-VEGF therapy transformed the management of wAMD and DME from the mid-2000s onward, converting conditions that frequently caused severe vision loss into ones where stabilization and, in many cases, functional improvement are achievable. Yet the injection burden associated with monthly or bimonthly dosing has long been identified as a factor in suboptimal real-world adherence, with patients and clinicians alike seeking regimens that reduce clinic visits without sacrificing disease control. Eylea HD joins a field that has already been moving toward extended durability as a central differentiating axis. Genentech’s faricimab (Vabysmo), approved in January 2022 for both wAMD and DME, introduced a bispecific mechanism targeting both VEGF-A and Angiopoietin-2, and carried labelling permitting up to 16-week dosing intervals from the outset of maintenance therapy. Genentech’s ranibizumab port delivery system, Susvimo, received US FDA approval for DME in February 2025, offering a surgically implanted refillable device that delivers continuous anti-VEGF exposure and requires refilling approximately every six months. The Eylea HD label update, at up to 20 weeks for eligible patients, extends the injectable interval further than any previously approved intravitreal anti-VEGF injection, as noted in the company’s announcement. The competitive context also includes an expanding biosimilar landscape for the original 2 mg aflibercept formulation, with Sandoz’s aflibercept-abzv (Enzeevu) receiving US FDA approval as an interchangeable biosimilar in August 2024. That dynamic adds complexity to Regeneron’s positioning of the higher-dose product, as cost-driven substitution of the reference 2 mg product becomes more feasible in parallel with the clinical case for the 8 mg formulation’s durability profile. Aflibercept itself is a fusion protein constructed from domains of VEGF receptor 1 and VEGF receptor 2 linked to an IgG1 Fc region, acting as a decoy receptor that sequesters VEGF-A, VEGF-B, and placental growth factor. Regeneron invented the molecule internally using its VelociSuite platform and has retained exclusive US commercialisation rights for the ophthalmic formulation throughout the product’s development history. The broader aflibercept franchise, including the original Eylea 2 mg product approved in 2011, has been one of Regeneron’s principal revenue sources for over a decade. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website