Adalimumab biosimilar (Sandoz)

Seven months after spinning off from Novartis, Sandoz is reported 6% growth in the first quarter thanks largely to its blossomming biosimilars business. In its opening months, after spinning off as a separate business from Novartis, Sandoz is riding the wave of a strong launch of its biosimilar version of AbbVie’s Humira (adalimumab). With Hyrimoz leading the way, sales of the company’s biosimilars reached $623 million in the first three months of this year, good for a 21% increase from the first quarter of last year. Meanwhile, Sandoz’s generics sales reached $1.87 billion in the first quarter, a 1% gain from the same period in 2023. That adds up to 6% growth rate for the company overall. During the period, biosimilar sales represented 25% of the company's total sales, up from 22% a year ago. Expect the trend to continue as Hyrimoz continues to gain steam and after Sandoz's $170 million purchase of Lucentis biosimilar Cimerli from Coherus BioSciences. In March, Coherus reported Cimerli sales of $52 million in the fourth quarter of 2023 and $125 million for the year. Cimerli was launched in the United States in September of last year. “This acquisition builds our leading ophthalmology platform in the U.S. and lays an even stronger foundation for future product launches,” Sandoz CEO Richard Saynor said during a quarterly conference call on Tuesday. As for the launch of Hyrimoz, Sandoz highlighted data from IQVIA that shows its offering is capturing 82% of the biosimilar prescriptions written for adalimumab through the week of April 25. The surge started on April 1 when pharmacy benefit manager CVS Caremark removed AbbVie’s branded Humira from its national commercial formularies and covered its biosimilar versions. As a result of CVS’s adjustment, analysts from Evercore ISI noted that new prescriptions of Hyrimoz skyrocketed from 640 to 8,300 in the first week of April. After Sandoz released financial results, analysts from Intron Health highlighted the importance of the company's claim that Hyrimoz has preferred access to 65% of CVS’s commercial business. The Intron team sees the company’s biosimilar business booming in the next few years, citing future launches of biosimilars to Biogen’s Tysabri, Regeneron and Bayer’s Eylea, Amgen’s Prolia and Johnson & Johnson’s Stelara. “We expect this division to become a much bigger part of the business and drive significant growth,” Intron wrote. “We expect this to continue to drive re-rating in the Sandoz shares.” Sandoz, which doesn’t reveal sales for its individual products, stuck to its guidance for 2024, expecting mid-single-digit percentage sales growth. “At this point, I think it's important that we build credibility as a new company,” Saynor said when asked why the company didn’t provide more clarity on its guidance. “It’s probably prudent to see how the next quarter evolves and look at that going forward.”

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Strong first quarter performance, with net sales [1] of USD 2.5 billion, up 6% in constant currencies (up 5% in USD)Biosimilar business growing 21% in constant currencies All regions contributing to growthAcquisition of CIMERLI® (ranibizumab-eqrn) completed in March 2024 Basel, May 7, 2024 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, today announced net sales for the first quarter 2024. Net sales were USD 2.5 billion, an increase of 6% in constant currencies compared to the same quarter of the prior year. Biosimilars saw another quarter of double-digit net sales growth, an increase of 21% in constant currencies. Generics sales remained in line with prior year levels. Richard Saynor, Chief Executive Officer of Sandoz, said: “We saw a strong start to the year as we report our 10th consecutive quarter of topline growth. The momentum in our business continues as demonstrated by double-digit growth in biosimilars and a positive contribution by all regions.” Mr. Saynor continued: “Biosimilars are a key element of performance, driven by strong results in our existing portfolio, demand for our recently launched product Hyrimoz® (adalimumab-adaz) in the US and the recent acquisition of CIMERLI® (ranibizumab-eqrn), which closed in early March. Generics remained in line with the strong prior year sales. Looking forward, we are confident in our ability to continue to grow our top line and meet our full-year net sales guidance of mid-single digits in constant currencies.” FIRST QUARTER NET SALES RESULTSNet sales for the first quarter were USD 2.5 billion, up 6% in constant currencies, compared to the first quarter of 2023. Volume contributed 10 percentage points of growth, partially offset by price erosion of 4 percentage points. Biosimilars were a key driver of growth in the quarter, while generics remained in line with the strong prior year sales. Net sales by business Three months ended March 31 Change % USD millions unless indicated otherwise 2024 2023 USD cc* Generics 1869 1868 0 1 Biosimilars 623 516 21 21 Net sales to third parties 2492 2384 5 6 *Constant currencies Generics overviewNet sales for the first quarter were USD 1.9 billion, up 1% in constant currencies, compared to the first quarter of 2023. Solid volume demand was partly offset by the impact from the withdrawal of apixaban in the Netherlands following a court decision in August 2023, an exceptional cough and cold season in the first half of 2023 and the timing of new launches in the US. Biosimilars overviewNet sales for the first quarter were USD 623 million, up 21% in constant currencies, compared to the first quarter of 2023. This strong double-digit biosimilar growth reflects the ongoing launch of Hyrimoz® high-concentration formulation, the acquisition of CIMERLI® as well as continued strong demand for our first-ever biosimilar, Omnitrope®. Net sales by region Three months ended March 31 Change % USD millions unless indicated otherwise 2024 2023 USD cc Europe 1326 1270 4 2 North America 524 496 6 6 International 642 618 4 12 Net sales to third parties 2492 2384 5 6 Europe overviewNet sales for the first quarter were USD 1.3 billion, up 2% in constant currencies, compared to the first quarter of 2023. Generic volume growth remained positive despite a strong prior year comparison from peak sales of apixaban and an exceptional cough and cold season. Biosimilars showed strong sales growth, led by demand for Omnitrope® and contribution from the recent launch of Tyruko® (natalizumab) in several key countries. North America overviewNet sales for the first quarter were USD 524 million, up 6% in constant currencies, compared to the first quarter of 2023. Growth was driven by the ongoing launch of Hyrimoz® in the US, continued demand for Omnitrope®, the acquisition of CIMERLI® which closed in early March, and the transfer of mature brands from our former parent in the fourth quarter of 2023. This was partly offset by a decline in generics sales due to the timing of new launches in the US. International overviewNet sales for the first quarter were USD 642 million, up 12% in constant currencies, compared to the first quarter of 2023. This was primarily a result of strong volume growth across both generics and biosimilars, the acquisition of Mycamine® in the prior year and favorable price dynamics. GUIDANCE 2024The company reiterates its full-year 2024 guidance, expecting net sales to grow mid-single digit in constant currencies versus prior year and core EBITDA margin around 20%. FIRST QUARTER STRATEGIC MILESTONESOn January 31, we announced the launch of Tyruko® in Germany. Developed by Polpharma Biologics, Tyruko® is the first and only biosimilar to treat relapsing remitting multiple sclerosis. The availability of Tyruko® is a crucial milestone in improving access to effective and safe therapies for those in Europe that need them most. On March 4, we announced the completion of the US biosimilar CIMERLI® acquisition from Coherus BioSciences, Inc, ahead of anticipated timelines. The acquisition builds on the leading Sandoz ophthalmic platform in the US and lays an even stronger foundation for future product launches. On March 5, we announced that Remco Steenbergen, currently a Sandoz Board member, will become a member of the Executive Committee and take on the responsibility of Sandoz CFO as of July 1, 2024. Remco will succeed Colin Bond who will step down from his position as of June 30, 2024, and retire in January 2025 per Swiss employment practice. Colin will be available for transition as a senior advisor through the end of 2024. On March 5, we also announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines including osteoporosis and cancer-related skeletal events. KEY LINKSWebcast – Live at 9am CETAnalyst Call PresentationAnalyst Consensus NON-IFRS MEASURES IN THIS DOCUMENT AS DEFINED BY SANDOZSandoz uses certain non-IFRS metrics when measuring performance, especially when measuring current period results against prior periods, including core results, constant currencies and free cash flow. Despite the use of these measures by management in setting goals and measuring Sandoz performance, these are non-IFRS measures that have no standardized meaning prescribed by IFRS Accounting Standards. As a result, such measures have limits in their usefulness to investors. Because of their non-standardized definitions, the non-IFRS measures (unlike IFRS measures) may not be comparable to the calculation of similar measures of other companies. These non-IFRS measures are presented solely to permit investors to more fully understand how Sandoz management assesses underlying performance. These non-IFRS measures are not, and should not be viewed as, a substitute for IFRS measures, and should be viewed in conjunction with IFRS financials. As an internal measure of Group performance, these non-IFRS measures have limitations, and Sandoz performance management process is not solely restricted to these metrics. The definitions of the non-IFRS financial metrics as used by Sandoz are as follows: Core resultsSandoz core results – including core EBITDA, core operating income, core net income and core earnings per share – exclude fully: The amortization and impairment charges of intangible assets other than software;Net gains and losses on fund investments and equity securities valued at fair value through profit and loss;Certain acquisition and divestment- related items;Tax liabilities for uncertain tax positions. The following items that exceed a threshold of USD 25 million are also excluded: Integration- and divestment- related income and expenses;Divestment gains and losses;Restructuring charges/releases and related items;Legal related items;Impairments of property, plant and equipment, software and financial assets;And income and expense items that management deems exceptional and that are or are expected to accumulate within the year to be over a USD 25 million threshold. Income tax impacts of such items are also excluded from core measures. Sandoz believes that investor understanding of its performance is enhanced by disclosing core measures of performance because, since core measures exclude items that can vary significantly from year to year, they enable a better comparison of business performance across years. For this same reason, Sandoz uses these core measures in addition to IFRS and other measures as important factors in assessing its performance. The following are examples of how these core measures are utilized: In addition to monthly reports containing financial information prepared under IFRS, senior management receives a monthly analysis incorporating these core measures;Annual budgets are prepared for both IFRS and core measures. As an internal measure of Sandoz performance, the core results measures have limitations, and the Sandoz performance management process is not solely restricted to these metrics. A limitation of the core results measures is that they provide a view of the Sandoz operations without including all events during a period, such as the effects of an acquisition, divestment, or amortization/impairments of purchased intangible assets, impairments to property, plant and equipment and restructurings and related items. Constant currenciesChanges in the relative values of non-US currencies to the US dollar can affect Sandoz financial results and financial position. To provide additional information that may be useful to investors, including changes in sales volume, Sandoz presents information about its net sales and various values relating to operating and net income that are adjusted for such foreign currency effects. Constant currency calculations have the goal of eliminating two exchange rate effects so that an estimate can be made of underlying changes in the consolidated income statement excluding the impact of fluctuations in exchanges rates: The impact of translating the income statements of consolidated entities from their non-USD functional currencies to USD;The impact of exchange rate movements on the major transactions of consolidated entities performed in currencies other than their functional currency. Sandoz calculates constant currency measures by translating the current year’s foreign currency values for sales and other income statement items into USD (excluding the IAS 29 “Financial Reporting in Hyperinflationary Economies” adjustments to the local currency income statements of subsidiaries operating in hyperinflationary economies), using the average exchange rates from the prior year and comparing them to the prior year values in USD. Sandoz uses these constant currency measures in evaluating its performance, since they may assist the Group in evaluating its ongoing performance from year to year. However, in performing its evaluation, Sandoz also considers equivalent measures of performance that are not affected by changes in the relative value of currencies. EBITDASandoz defines earnings before interest, tax, depreciation, and amortization (EBITDA) as operating income, excluding depreciation of property, plant and equipment and right-of-use assets, amortization of intangible assets, impairments of property, plant and equipment, right-of-use assets, and intangible assets. Core EBITDA marginSandoz defines core EBITDA margin as the percentage of core EBITDA over net sales to third parties. It is an indicator to measure the profitability of the Group. CurrenciesReferences to “USD” or “U.S. dollars” are to the lawful currency of the United States of America. RoundingCertain figures contained in the media release, including financial information presented in millions or thousands, certain operating data and percentages describing financial information or market shares, have been subject to rounding. Accordingly, in certain instances, the amounts shown as totals in tables or elsewhere may not conform exactly to the arithmetic total of the figures that precede them. In addition, certain percentages reflect calculations based upon the underlying information prior to rounding and, accordingly, may not conform exactly to the percentages that would be derived if the relevant calculations were based upon the rounded numbers. 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 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. ABOUT SANDOZSandoz (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 more than 100 nationalities work together to ensure 800 million patient treatments are provided annually by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1500 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 first biosimilar in 2006. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer+49 171 838 4838 Karen M. King+1 609 722 0982 Chris Lewis+49 174 244 9501 Laurent de Weck+41 61 529 14 85 SUPPORTING FINANCIAL INFORMATION Quarterly sales Q1 2024 USD millions unless indicated otherwise Q1 2024 Change % USD cc Generics 1869 0 1 Biosimilars 623 21 21 Net sales to third parties 2492 5 6 Europe 1326 4 2 North America 524 6 6 International 642 4 12 Net sales to third parties 2492 5 6 FY 2023 USD millions unless indicated otherwise Q1 2023 Change % Q2 2023 Change % Q3 2023 Change % Q4 2023 Change % USD cc USD cc USD cc USD cc Generics 1868 2 6 1850 4 6 1794 5 4 1920 6 6 Biosimilars 516 11 17 533 13 14 543 7 4 623 29 26 Net sales to third parties 2384 4 9 2383 5 8 2337 6 4 2543 11 10 Europe 1270 10 16 1277 14 12 1204 11 3 1272 10 4 North America 496 (5) (3) 508 (4) (2) 510 (4) (3) 615 20 20 International 618 (1) 4 598 (3) 8 623 3 12 656 4 14 Net sales to third parties 2384 4 9 2383 5 8 2337 6 4 2543 11 10 [ 1 ] Net sales in this document refer systematically to net sales to third parties. Attachment SANDOZ Q1 Sales Media Release