This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.

Start Date01 Jan 2026

Sponsor / Collaborator

Columbia University

[+2]

100 Clinical Results associated with Somatropin(Sandoz International Gmbh)

100 Translational Medicine associated with Somatropin(Sandoz International Gmbh)

100 Patents (Medical) associated with Somatropin(Sandoz International Gmbh)

Literatures (Medical) associated with Somatropin(Sandoz International Gmbh)

01 Dec 2023·Drug safety

Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch

Review

Author: Kottke, Andrea ; Cohen, Hillel P ; Kalsekar, Sameer ; Anjaneya, Pradeep ; Sagi, Sreedhar

BACKGROUND:

Biosimilars are additional treatment options that are approved based on robust analytical and clinical comparisons with their reference biologic. At the time of initial approval, the full safety profile of a biosimilar is inferred from the reference biologic. Nonetheless, there are still lingering concerns related to the long-term safety of biosimilars. Therefore, we reviewed the post-approval pharmacovigilance data for eight marketed biosimilars from one Marketing Authorization Holder (MAH) to summarize their safety experience in a real-world setting for up to 18 years since their first biosimilar launch.

METHODS:

Post-approval cumulative patient exposure and safety experience for eight Sandoz biosimilars [adalimumab (Hyrimoz^®), epoetin alfa (Binocrit^®), etanercept (Erelzi^®), filgrastim (Zarzio^®), infliximab (Zessly^®), pegfilgrastim (Ziextenzo^®), rituximab (Rixathon^®), and somatropin (Omnitrope^®)] was summarized based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding health authority-authored PSUR assessment reports, where available, as of 31 January 2023. Exposure to all biosimilars was calculated in patient treatment days (PTD) except for rituximab, which was expressed in number of patient doses (PD).

RESULTS:

The combined post-approval cumulative exposure to seven out of the eight marketed Sandoz biosimilars was more than 1.3 billion PTD and for rituximab more than 1.8 million PD. Overall, a critical analysis of the cumulative safety data of all eight Sandoz biosimilar PSURs concluded that the overall benefit-risk profile of each remains favorable and is consistent with the respective reference biologics.

CONCLUSIONS:

This is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The long-term safety of biosimilars demonstrated here provides strong support for the concept of biosimilarity.

01 Mar 2021·Journal of endocrinological investigationQ2 · MEDICINE

Safety and effectiveness of a somatropin biosimilar in children requiring growth hormone treatment: second analysis of the PATRO Children study Italian cohort

Q2 · MEDICINE

Article

Author: Minelli, R ; Bona, G ; Zouater, H ; Zucchini, S ; Persani, L ; Guazzarotti, L ; Perrone, L ; Antoniazzi, F ; Stagi, S ; Aversa, T ; Gallinari, P ; Iughetti, L ; Greggio, N A ; Fedeli, P ; Giavoli, C ; Pozzobon, G ; Ragusa, L ; Tornese, G ; Zecchino, C

PURPOSE:

To investigate the long-term safety (primary endpoint) and effectiveness (secondary endpoint) of the somatropin biosimilar Omnitrope^®.

METHODS:

PATRO Children is an ongoing, multicenter, observational, post-marketing surveillance study. Children who received Omnitrope^® for any indication were included. Adverse events (AEs) were evaluated in all study participants. Auxological data, including height standard deviation scores (HSDS) and height velocity standard deviation scores (HVSDS), were used to assess effectiveness. In this snapshot analysis, data from the Italian subpopulation up to August 2017 were reported.

RESULTS:

A total of 291 patients (mean age 10.0 years, 56.0% male) were enrolled at 19 sites in Italy. The mean duration of Omnitrope^® treatment was 33.1 ± 21.7 months. There were 48 AEs with a suspected relationship to the study drug (as reported by the investigator) that occurred in 35 (12.0%) patients, most commonly headache, pyrexia, arthralgia, insulin-like growth factor above normal range, abdominal pain, pain in extremity and acute gastroenteritis. There were no confirmed cases of type 1 or type 2 diabetes; however, two patients (0.7%) had impaired glucose tolerance that was considered Omnitrope^® related. The mean HSDS increased from - 2.41 ± 0.73 at baseline (n = 238) to - 0.91 ± 0.68 at 6.5 years (n = 10). The mean HVSDS increased from - 1.77 ± 1.38 at baseline (n = 136) to 0.96 ± 1.13 at 6.5 years (n = 10).

CONCLUSIONS:

In this sub-analysis of PATRO Children, Omnitrope^® appeared to have acceptable safety and effectiveness in the treatment of in Italian children, which was consistent with the earlier findings from controlled clinical trials.

News (Medical) associated with Somatropin(Sandoz International Gmbh)

07 Aug 2025

·www.globenewswire.com

Sandoz delivers strong H1 2025 results, with accelerated sales growth in the second quarter

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Basel, August 7, 2025 – Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its financial results for the first half of 2025. Growth in this document is shown at constant currencies (CC)[1] unless stated otherwise. FINANCIAL RESULTS H1 2025H1 2024changeUSD mUSD mUSD %CC %CGR %[2] Net sales5,2325,0474%4%6% Generics3,7363,7041%1%2% Biosimilars1,4961,34311%12%17% Core EBITDA1,04688518%20% Core EBITDA margin (%)20.0%17.5% Core diluted earnings per share (USD)1.461.1230%33% Management free cash flow503237nm[3] Richard Saynor, Chief Executive Officer of Sandoz, said: “The first half of the year marked another phase of good progress for Sandoz. Strong underlying sales growth was underpinned by the double-digit performance from our biosimilars which, in the second quarter, represented 30% of net sales for the first time, marking a true milestone for the company. Europe and International also performed particularly well, while we launched more important medicines for patients in North America. “Reflecting this year’s launch program, weighted to the second half, we anticipate an even stronger sales performance in the second half, particularly in North America. Further investments in our biosimilars future, in Slovenia and via the proposed acquisition of Just-Evotec Biologics EU SAS, reflect the latest step in our strategic plan to capitalize on the unprecedented patent-expiries’ opportunity over the next ten years. This will only be enhanced by the effects of regulatory streamlining. It is the combination of the growing platform of opportunities, consistently strong financial results and our unrelenting focus on patients that offers such attractive long-term value for our stakeholders.” FINANCIAL HIGHLIGHTS H1 2025 net sales of USD 5,232 million: Up by 4% at CC and USD, with volume growth of 7%; on a CGR basis, H1 net sales grew by 6%In the second quarter, accelerated growth of 5% at CC and 8% in USD; growth of 7% at CGRBiosimilars H1 sales up by 12% at CC and 17% at CGRH1 generics growth of 1% at CC and 2% at CGRThe 10 largest-selling medicines grew by a combined 10% at CC and represented 33% of net sales A core EBITDA margin in H1 of 20.0%, representing a 2.5 percentage-point year-on-year improvement, primarily driven by operating leverage and the mix of salesManagement free cash flow in H1 of USD 503 million (H1 2024: USD 237 million). Free cash flow of USD 207 million (H1 2024: USD 21 million)Core diluted earnings per share of USD 1.46 in H1 represented growth of 33% at CC and 30% in USDFull-year 2025 guidance confirmed: mid-single-digit net-sales growth at CC and a core EBITDA margin of around 21% BUSINESS HIGHLIGHTS There were a number of business highlights since the publication of the Q1 2025 sales update. Biosimilars The company recently signed a non-binding term sheet with Evotec SE to acquire its Just-Evotec Biologics’ in-house development and manufacturing capabilities in Toulouse, France. The proposed transaction would seamlessly align with the strategic objective of capitalizing on the projected USD 300 billion biosimilar-market opportunity over the next 10 years[4]Sandoz recently announced the start of construction for a new, state-of-the-art biosimilars production center for sterile product manufacturing in Brnik, Slovenia. This complements ongoing investments in Slovenia, namely a new biosimilar drug-substance production center in Lendava and a biosimilar development center in LjubljanaFollowing feedback from major regulatory authorities, Sandoz has decided to streamline the clinical-development programs for its proposed nivolumab and ocrelizumab biosimilars, respectively. The company is winding down the Phase III NivoReach trial for its proposed biosimilar nivolumab. Sandoz is also modifying its Strive-MS integrated Phase I/III trial to become a comparative pharmacokinetic trial for its proposed ocrelizumab biosimilar. The development programs, including comprehensive analytical and clinical pharmacokinetic data, have been designed to align with updated regulatory guidance and confirm biosimilarity to their respective reference medicines, while maintaining the highest scientific and regulatory standardsThe aforementioned streamlining reflects ongoing encouraging and favorable regulatory developments for biosimilars and follows Sandoz’s decision earlier in the year to minimize its Phase III trial for its proposed pembrolizumab biosimilar Launches Sandoz recently launched Wyost® and Jubbonti® in the US, the first and only interchangeable denosumab biosimilars. Pyzchiva® (ustekinumab) was also launched in the US, including in private label. Finally, a Pyzchiva autoinjector was also rolled out to become the first commercially available ustekinumab biosimilar in a pre-filled pen in EuropeAnticipated biosimilar launches in the second half of the year include Wyost & Jubbonti and Afqlir® (aflibercept) in Europe, while the company retains its ambition to launch Tyruko® (natalizumab) in the US before the end of the year[5] FULL-YEAR 2025 GUIDANCE The company expects further major biosimilar launches this year, while price erosion is expected to return to normalized levels of a low to mid-single-digit percentage. Sandoz continues to anticipate core EBITDA-margin expansion this year to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the company confirms its expectations for 2025: Net sales to grow at CC by a mid-single-digit percentageA core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. H1 AND Q2 2025 NET SALES Net sales by business H1 H1 2025% of net salesH1 2024changeUSD m USD mUSD %CC %CGR % Generics3,736713,7041%1%2%Biosimilars1,496291,34311%12%17%Net sales5,2321005,0474%4%6% Net sales for the first half of 2025 were USD 5,232 million, up by 4% at CC and by 6% at CGR. Volumes grew by 7%, partly offset by price erosion of 3%; the erosion was in line with a full-year assumption of a low to mid-single-digit decline. Net-sales growth was primarily driven by the performance of biosimilars, which continues to benefit from an extensive pipeline and launch program. Generics overviewNet sales of generics in H1 were USD 3,736 million, reflecting growth of 1% at CC and 2% at CGR. Generics represented 71% of net sales (H1 2024: 73%, Q2 2025: 70%). Europe net sales of generics grew by 2% at CC in the first half, reflecting the impact of launches in 2024. International net sales of generics declined by 1% at CC; after adjusting for the 2024 divestment of the Sandoz business in China, International net sales of generics grew by 3% at CGR. In North America, generics net-sales growth of 2% at CC benefited from the successful launch of paclitaxel in 2024. Biosimilars overviewNet sales of biosimilars in H1 of USD 1,496 million reflected growth of 12% at CC and 17% at CGR. Biosimilars represented 29% of total net sales (H1 2024: 27%, Q2 2025: 30%). Strong Europe biosimilars net-sales growth of 17% at CC benefited from a number of good performances, including recently launched Pyzchiva and Tyruko, while strong International biosimilar net-sales growth of 30% at CC partly reflected the strong contribution from Omnitrope® (somatropin). Major biosimilar launches in International in 2025 will all occur in the second half of the year. North America biosimilar net sales declined by 9% at CC in the half, reflecting the withdrawal of Cimerli in Q1 2025 and the effect of private-label adalimumab pricing; excluding the impact of the 2024 acquisition of Cimerli, North America biosimilar net sales grew by 9%. Q2 Q2 2025% of net salesQ2 2024changeUSD m USD mUSD %CC %CGR % Generics1,927701,8355%2%3%Biosimilars8253072015%12%20%Net sales2,7521002,5558%5%7% Net sales for the second quarter were USD 2,752 million, up by 5% at CC and by 7% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%. Net sales by region H1 H1 2025% of net salesH1 2024changeUSD m USD mUSD %CC %CGR % Europe2,832542,6348%6%6%International1,284251,2691%5%8%North America1,116211,144-2%-1%4%Net sales5,2321005,0474%4%6% Europe overviewNet sales in Europe in H1 were USD 2,832 million, reflecting growth of 6% at CC and CGR. Europe net sales of generics grew by 2% at CC in the first half, with growth in biosimilars of 17% at CC primarily a result of commercial execution and recent launches, including Pyzchiva and Tyruko. International overviewNet sales in International in H1 were USD 1,284 million, with growth of 5% at CC and 8% at CGR. In the second quarter, International net sales grew by 11% at CC and by 13% at CGR, despite major biosimilar launches this year all coming in H2. Pricing increased in generics during the first half of 2025, with strong International biosimilar net-sales growth of 30% at CC partly a result of the continued good performance from Omnitrope. North America overviewNet sales in North America in H1 were USD 1,116 million, reflecting a decline of 1% at CC. Growth at CGR however, namely excluding the impact of the acquisition of Cimerli, amounted to 4%. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the aforementioned impact of the Cimerli acquisition. Price erosion was driven by reduced Cimerli sales, private-label adalimumab pricing and Omnitrope. Q2 Q2 2025% of net salesQ2 2024changeUSD m USD mUSD %CC %CGR % Europe1,460531,30812%6%6%International6942562711%11%13%North America59822620-4%-3%5%Net sales2,7521002,5558%5%7% H1 2025 KEY OPERATING AND NON-OPERATING RESULTS H1 2025H1 2024changeUSD mUSD mUSD %CC % Net sales5,2325,0474%4%Gross profit2,4112,3801%2%Operating income60233281%90%EBITDA87057651%55%Net income377151nmnm Core results Core gross profit2,5752,5441%2%Core gross profit margin (%)49.2%50.4% Core operating income90176318%20%Core operating income margin (%)17.2%15.1% Core EBITDA1,04688518%20%Core EBITDA margin (%)20.0%17.5% Core net income63548431%34%Core diluted earnings per share (USD)1.461.1230%33% Core gross profit amounted to USD 2,575 million (H1 2024: USD 2,544 million), resulting in a core gross profit margin of 49.2% (H1 2024: 50.4%). The favorable product mix from double-digit biosimilars growth, as well as operational improvements, was more than offset by price erosion and inflation on cost of goods sold. Core EBITDA was USD 1,046 million (H1 2024: USD 885 million), resulting in a core EBITDA margin of 20.0% (H1 2024: 17.5%). The strong increase was primarily driven by leveraging expenses from a growing top line and savings from the transformation program. EBITDA was USD 870 million (H1 2024: USD 576 million). Core adjustments for EBITDA in the first half of 2025 were USD 176 million (H1 2024: USD 309 million). These were mainly driven by separation costs of USD 156 million, costs of rationalization of internal manufacturing sites of USD 54 million and favorable impacts from adjustments for legal costs of USD 28 million. Core net income was USD 635 million (H1 2024: USD 484 million), mainly driven by higher core operating income and a lower core net financial result, partly offset by higher core income taxes, while the effective tax rate remained broadly unchanged. Core diluted earnings per share were USD 1.46 (H1 2024: USD 1.12). The weighted average number of shares diluted was 435.8 million as of June 30, 2025, versus 432.2 million in the prior-year period. NET CASH FLOW, NET WORKING CAPITAL AND NET DEBT H1 2025H1 2024changeUSD mUSD mUSD m Net cash flows from operating activities523229294Cash flows used for net capex(310)(205)(105)Free cash flow20721186Management free cash flow503237266 Sandoz generated net cash flows from operating activities of USD 523 million in the first half of the year (H1 2024: USD 229 million). This was mainly driven by working-capital enhancements through improvements in receivables; inventory levels were stable versus December 2024. Cash flows used for capital expenditures were USD 310 million (H1 2024: USD 205 million). This included the company’s ongoing investment in Slovenia, namely a new biosimilar drug substance production center in Lendava, a biosimilar development center in Ljubljana and a new production plant in Brnik. It also included separation-related investments in facilities and technology. Management free cash flow, defined as free cash flow adjusted for one-off items, was USD 503 million (H1 2024: USD 237 million). The increase was mainly driven by a higher core EBITDA. Free cash flow amounted to USD 207 million (H1 2024: USD 21 million). The improvement was mainly due to increased net cash flows from operating activities, partly offset by higher cash flows used for capital expenditures. Jun 30, 2025Dec 31, 2024changeUSD mUSD mUSD m Net working capital3,6383,486152Net debt3,9093,329580 Net working capital increased by USD 152 million, largely due to currency-translation effects of USD 305 million, offset by improvements in underlying net working capital. Non-current financial debt increased by USD 811 million, reflecting the issuance of three bonds in the first half of 2025 of EUR 500 million and CHF 400 million, respectively and currency-translation effects. This was partly offset by the repayment of USD 750 million equivalent in USD and EUR term loans. Cash and cash equivalents increased by USD 198 million as cash generated from operating activities and proceeds from the issuance of non-current financial debt were partly offset by the repayment of term loans, the annual dividend payment and purchases of property, plant and equipment. As a result of the above, net debt increased to USD 3.9 billion compared to USD 3.3 billion on December 31, 2024, mainly related to currency-translation effects of USD 422 million. CONFERENCE CALL A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. NOTES The performance shown in this announcement covers the six-month period to June 30, 2025 (H1 2025) and the three-month period to June 30, 2025 (Q2 2025), compared to the six-month period to June 30, 2024 (H1 2024) and the three-month period to June 30, 2024 (Q2 2024), respectively. Commentary is based on the performance in H1 2025, unless stated otherwise. CALENDAR The company intends to publish its nine-months’ and third-quarter sales update on October 30, 2025. HALF-YEAR REPORT Sandoz published its Half-Year Report 2025 today, which can be found here. [1] Non-IFRS measures are defined in the Supplementary financial information section of the Half-Year Report 2025. [2] 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. In this announcement, adjustments relate to the impact of the 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and the 2024 divestment of the Sandoz business in China. [3] Not meaningful. [4] Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035.[5] Subject to regulatory approval of John Cunningham virus assay and pending litigation. CONTACTS Media RelationsInvestor Relationsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This 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 materialize 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 update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information section of the Half-Year Report 2025. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. SUPPORTING FINANCIAL INFORMATION 2025 NET SALES By business Q1 2025change Q2 2025change H1 2025change USD mUSD %CC % USD mUSD %CC % USD mUSD %CC %Generics 1,809-3%0% 1,9275%2% 3,7361%1%Biosimilars6718%11% 82515%12% 1,49611%12%Net sales 2,4800%3% 2,7528%5% 5,2324%4% By region Q1 2025change Q2 2025change H1 2025change USD mUSD % CC % USD mUSD %CC % USD mUSD %CC %Europe 1,3723%7% 1,46012%6% 2,8328%6%International590-8%-2% 69411%11% 1,2841%5%North America518-1%1% 598-4%-3% 1,116-2%-1%Net sales 2,4800%3% 2,7528%5% 5,2324%4% By region and business H1 2025H1 2024changeUSD mUSD mUSD %CC %CGR % Europe2,8322,6348%6%6%Generics1,9411,8813%2%2%Biosimilars89175318%17%17%International1,2841,2691%5%8%Generics1,0191,055-3%-1%3%Biosimilars26521424%30%30%North America1,1161,144-2%-1%4%Generics7767681%2%2%Biosimilars340376-10%-9%9%Net sales5,2325,0474%4%6% 2024 NET SALES By business Q1 2024change Q2 2024change Q3 2024change Q4 2024change USD mUSD %CC % USD mUSD %CC % USD mUSD %CC % USD mUSD %CC %Generics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net sales 2,49256 2,55579 2,5951112 2,71579 By region Q1 2024change Q2 2024change Q3 2024change Q4 2024change USD mUSD %CC % USD mUSD %CC % USD mUSD %CC % USD mUSD %CC %Europe 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net sales 2,49256 2,55579 2,5951112 2,71579 H1 2025: RECONCILIATION FROM IFRS RESULTS TO CORE RESULTS (USD millions unless indicated otherwise)IFRS resultsAmorti-zation of intangibleassets[6]Impair-ments[7]Acquisition or divest-ment of businesses and related items[8]Other items[9]Core resultsNet sales5,232––––5,232Other revenues33––––33Cost of goods sold(2,854)10115–48(2,690)Gross profit2,41110115–482,575Selling, general and administration(1,192)–––10(1,182)Development and regulatory(504)–1–2(501)Other income222––(10)(109)103Other expense(335)–––241(94)Operating income[10]60210116(10)192901Interest expense(111)––––(111)Other financial income and expense13–––316Income before taxes50410116(10)195806Income taxes[11](127) (171)Net income 377 635Basic earnings per share (USD)0.87 1.47Diluted earnings per share (USD)0.87 1.46 [6] Amortization of intangible assets: cost of goods sold includes the amortization of rights to currently marketed products and other production-related intangible assets.[7] Impairments: cost of goods sold and development and regulatory include impairment charges related to intangible assets. [8] Acquisition or divestment of businesses and related items: other income includes a release related to the China business divestment.[9] Other items: cost of goods sold, other income and other expense include the Group-wide rationalization of manufacturing sites; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the separation costs related to the spin-off; selling general and administration, development and regulatory, other income and other expense include the costs related to the transformation program and other restructuring charges; other income and other expense include legal related charges and adjustments to contingent considerations; other expense includes an onerous contract adjustment; other financial income and expense includes the net monetary impacts on the restatement of non-monetary items for subsidiaries in hyperinflationary economies.[10] For further breakdown of core adjustments by category, refer to table Reconciliation from IFRS operating income to core net income in the Half-Year Report 2025.[11] Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Due to these factors and the differing applicable tax rates in the various jurisdictions, the tax on the total adjustments of USD 302 million to arrive at the core results before tax amounts to USD 44 million. The average tax rate on the adjustments was 14.6%. Further reconciliations of core results are available in the Supplementary financial information of the Half-Year Report 2025, which can be found here. Attachment Media release_H1 2025

Phase 3AcquisitionBiosimilarDrug ApprovalFinancial Statement

30 Apr 2025

·www.globenewswire.com

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This 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 materialize 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 update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the latest Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

BiosimilarDrug ApprovalPhase 3Phase 1Acquisition

09 Aug 2024

·www.fiercepharma.com

Sandoz lifts guidance after Humira biosimilar drives another quarter of sales growth

Novartis spinout Sandoz garnered $2.6 billion in second-quarter product sales. After the performance, the company raised its sales guidance for the year. After taking a market share lead in the crowded Humira biosimilar space and with other key launches in the works, Novartis spinout Sandoz is raising its full-year sales guidance.Sandoz previously communicated that it expects 2024 sales growth to reach mid-single-digit percentages. Now, after reporting second-quarter results, the company said it expects mid- to high-single-digit growth for the year.The company collected $2.6 billion in net sales during the second quarter, representing 9% sales growth compared to the same period last year.The boost was driven by the drugmaker’s clutch of biosimilars, which together saw an "exceptional" growth rate of 29%, CEO Richard Saynor said on Sandoz’s recent earnings call. Sandoz does not report individual product sales. Within the drugmaker’s biosimilar franchise, Humira copycat Hyrimoz is the standout. The med holds an 81% market share in the crowded space of biosimilar competitors to AbbVie’s popular immunology drug and has the “broadest payer coverage” of them all, according to a Sandoz investor presentation (PDF).Sandoz took on a unique strategy with its Hyrimoz, launching both a branded and an unbranded version and linking with CVS Health’s biosimilar subsidiary Cordavis on a co-labeled version. Earlier this year, CVS Caremark pulled AbbVie’s branded Humira from its national commercial formularies, in turn sending Hyrimoz prescriptions skyrocketing.Outside of Hyrimoz, the biosimilar maker has a number of potentially big launches in the works. Just recently, Sandoz launched its version of Johnson & Johnson’s Stelara in Europe. That biosim is expected to hit the U.S. in February 2025 in accordance with a J&J settlement. After that, the company looks to launch its copies of Amgen’s bone drugs Xgeva and Prolia, which will be branded as Wyost and Jubbonti, respectively, in the second quarter of next year. Regeneron and Bayer’s ophthalmology powerhouse Eylea is another potential victim of Sandoz's biosimilar ambitions. The companies are engaged in patent litigation right now, but Saynor said the company's Eylea biosimilar should arrive in the coming years.In the meantime, Sandoz can also still rely on its aging Omnitrope to buoy sales alongside Hyrimoz. That drug, a biosimilar to Pfizer’s human growth hormone Genotropin, predates even the FDA’s biosimilar approval pathway with its 2006 nod. Since then, Omnitrope has overtaken Pfizer’s original as the market leader, and its sales were still on the rise in the second quarter of 2024.It hasn’t yet been a year since Sandoz spun out of Novartis, but the company is already hard at work initiating a “multi-year transformation program” to simplify its organizational structure. Under that program, the company expects savings of $50 million in this year's second half. By 2026, Sandoz is targeting annual savings of $200 million.

BiosimilarPatent InfringementPatent Expiration

100 Deals associated with Somatropin(Sandoz International Gmbh)

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Failure to Thrive	United States	Sandoz, Inc.	23 Apr 2010
Idiopathic short stature	Japan	Clariant AG	22 Jun 2009
Dwarfism, Pituitary	European Union	Sandoz GmbH	12 Apr 2006
Dwarfism, Pituitary	Iceland	Sandoz GmbH	12 Apr 2006
Dwarfism, Pituitary	Liechtenstein	Sandoz GmbH	12 Apr 2006
Dwarfism, Pituitary	Norway	Sandoz GmbH	12 Apr 2006
Growth Disorders	European Union	Sandoz GmbH	12 Apr 2006
Growth Disorders	Iceland	Sandoz GmbH	12 Apr 2006
Growth Disorders	Liechtenstein	Sandoz GmbH	12 Apr 2006
Growth Disorders	Norway	Sandoz GmbH	12 Apr 2006
Growth hormone deficiency	European Union	Sandoz GmbH	12 Apr 2006
Growth hormone deficiency	Iceland	Sandoz GmbH	12 Apr 2006
Growth hormone deficiency	Liechtenstein	Sandoz GmbH	12 Apr 2006
Growth hormone deficiency	Norway	Sandoz GmbH	12 Apr 2006
Prader-Willi Syndrome	European Union	Sandoz GmbH	12 Apr 2006
Prader-Willi Syndrome	Iceland	Sandoz GmbH	12 Apr 2006
Prader-Willi Syndrome	Liechtenstein	Sandoz GmbH	12 Apr 2006
Prader-Willi Syndrome	Norway	Sandoz GmbH	12 Apr 2006
Turner Syndrome	European Union	Sandoz GmbH	12 Apr 2006
Turner Syndrome	Iceland	Sandoz GmbH	12 Apr 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PATRO Adults Study (ENDO2019)	Not Applicable	Growth hormone deficiency	1,298	Omnitrope®	sfmiddmtso(quwucbvmdz) = 4009 adverse events (AEs) in 889 patients have been reported, with 643 (353 [27.2%] patients) of these regarded as serious. 154 AEs in 92 (7.1%) patients were suspected to be related to Omnitrope®; these included general disorders/administration site conditions in 23 patients, nervous system disorders in 23 patients and musculoskeletal/connective tissue disorders in 36 patients. A total of 20 serious AEs (SAEs) in 17 (1.3%) patients were suspected to be related to Omnitrope®, leading to treatment discontinuation in 5 patients. Overall, 328 patients (282 with combined GHD) have discontinued the study, 73 (61 with combined GHD) due to AEs (26 were considered related to rhGH treatment). xyofxvvykv (imboqzdzkq ) View more	Positive	30 Apr 2019
SUN-255 PATRO Children (ENDO2019)	Not Applicable	-	-	Omnitrope (US patients)	itzcfzijch(jelfzhwnyt) = hslcydpqdt pebkzinlqk (yhzhikukxm, 17.39) View more	Positive	30 Apr 2019
SUN-255 PATRO Children (ENDO2019)	Not Applicable	-	-	Omnitrope (ROW patients)	itzcfzijch(jelfzhwnyt) = rylewjamhg pebkzinlqk (yhzhikukxm, 26.89) View more	Positive	30 Apr 2019
SUN-254 (ENDO2019)	Phase 4	Small-for-dates baby	278	Omnitrope®	tfefcqjouo(tcmmqukdti) = Serious AEs (n=125) have been reported in 68 patients; 4 of these (in 3 patients) were suspected as possibly related to study treatment, and only one resulted in study drug being permanently discontinued vlgfqbkdzv (rczkjyuiyw ) View more	Positive	30 Apr 2019
ESPE2014	Phase 3	Dwarfism, Pituitary	70	Omnitrope	xnwrwfxsln(vtzcfcdanv) = No adverse events were reported hyprsazpgs (rcibyhnwgd )	Positive	18 Sep 2014

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