On March 5, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and YASKAWA Electric Corporation (TSE: 6506, President and CEO; Masahiro Ogawa, "YASKAWA") reported the companies signed a definitive agreement to establish a joint venture for the development of a cell therapy product manufacturing platform utilizing the dual-arm robot "Maholo" (Press release, Astellas, MAR 5, 2025, View Source [SID1234650923]). In addition, the joint venture will offer platform access to startups and academic institutions, fostering collaboration and innovation in the field of cell therapy.

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In the pharmaceutical industry, the commercialization of cell therapy faces many challenges stemming from the complex nature of the manufacturing process, in particular, related to the accuracy and reproducibility of cell manufacturing. Furthermore, the need for a skilled workforce, coupled with the time and cost investments required for technology transfer to manufacturing facilities, presents additional hurdles. Based on the memorandum of agreement signed in May, 2024, Astellas and YASKAWA have been advancing discussions toward establishing a joint venture to leverage their mutual strengths and accelerate efforts to address these challenges.

The planned joint venture will leverage Astellas’ expertise in R&D and manufacturing for cell therapy and the dual arm robot "Maholo," developed by YASKAWA’s subsidiary, Robotic Biology Institute. The closing and establishment of the joint venture company are subject to certain closing conditions, including receipt of required regulatory approvals.

Joint Venture Company: Overview

Name

To be determined

Capital

4.5 billion yen (includes capital reserve)

Capital Structure

Astellas 60%, YASKAWA 40%

Establishment

（tentative）

September 2025

Business

Develop a cell therapy product manufacturing platform and

offer access to startups and academic institutions.

1. Explore a manufacturing process with high precision and

reproducibility using ‘Maholo’ and optimize the digitized

manufacturing process with AI

2. Transfer the digitalized manufacturing process to ‘Maholo’

at other manufacturing facilities via one-click* transfer and

develop a cell manufacturing platform that meets GMP conditions

3. Develop manufacturing processes for cell therapy product

candidates of partners, such as academia and startups,

as well as manufacture investigational drugs in GMP facilities

* GMP (Good Manufacturing Practice):

A standard for ensuring the safety and quality of pharmaceuticalproduct manufacturing

* One Click Transfer:

Rapid transfer of established manufacturing process to facilities without hands-on training of workers

Through the establishment of a joint venture and the development of a cell therapy manufacturing platform, Astellas is committed to addressing the challenges of commercializing cell therapy and supporting academia and startup companies in implementing innovative cell therapies. By integrating advanced technologies into its cell therapy expertise, Astellas aims to develop potentially transformative cell therapy for patients with limited or no treatment options. Please visit this for more details.

YASKAWA has provided automation solutions for medical testing processes, including cancer genome diagnostics, iPS cell culture, and PCR testing, through delivering "Maholo." With the establishment of a joint venture, YASKAWA aims to expand the use cases of robots in the field of cell therapy beyond the existing life science field.

On March 5, 2025 Sanofi reported that it has successfully priced its offering of EUR 1.5 billion of notes across 2 tranches (Press release, Sanofi, MAR 5, 2025, View Source [SID1234650978]):

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•
€850 million floating rate notes, due March 2027, bearing interest at 3-month Euribor plus 0.300%

•
€650 million fixed rate notes, due March 2031, bearing interest at an annual rate of 2.750%.

The notes are being issued off the company’s Euro Medium Term Note Program.

Sanofi intends to use the net proceeds of the offering for general corporate purposes.

The transaction has been led by Deutsche Bank and J.P. Morgan as Global Coordinators, and ING, Santander CIB and Unicredit, all as Joint Lead Managers.

On March 5, 2025 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Fate Therapeutics, MAR 5, 2025, View Source [SID1234650907]).

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"We begin 2025 with resolve and focus to advance our lead clinical programs in autoimmunity and oncology," said Bob Valamehr, Ph.D. MBA, President and Chief Executive Officer of Fate Therapeutics. "The team continues to make great progress in our pursuit of achieving therapeutic differentiation for patients with B cell-mediated autoimmune diseases, and we look forward to providing clinical and regulatory updates as we advance our FT819 off-the-shelf CAR T-cell product candidate in SLE. We remain focused on driving patient enrollment and engaging with the FDA to further discuss novel development pathways for CAR T-cell therapy in autoimmune disease, including the use of fludarabine-free conditioning as well as add-on to maintenance therapy without conditioning. We also plan to explore FT819 clinical trial expansion in additional autoimmune diseases. In addition, our FT825 off-the-shelf CAR T-cell program for advanced solid tumors is advancing into higher-dose cohorts as monotherapy and in combination with monoclonal antibody therapy under our collaboration with Ono Pharmaceutical. We look forward to sharing clinical data from these two high-priority programs throughout the year."

FT819 iPSC-derived 1XX CAR T-cell Program

•
Phase 1 Dose Expansion Initiated for SLE using Flu-free Conditioning Regimen. Based on clinical data from the first three patients treated with FT819 in its ongoing multi-center, Phase 1 clinical trial for moderate-to-severe systemic lupus erythematosus (SLE) (NCT06308978), the Company has initiated dose expansion in up to 10 patients at 360 million cells. The dose expansion stage is designed to evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, followed by a single dose of FT819. The Company is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. FT819 is the Company’s off-the-shelf CD8αβ+ T-cell product candidate that incorporates a CD19-targeted chimeric antigen receptor (CAR) with a novel 1XX costimulatory domain into the T-cell receptor alpha constant (TRAC) locus.
•
Clinical Data from First Three SLE Patients Presented at ASH (Free ASH Whitepaper). In December 2024, the Company highlighted clinical and translational data from the first three patients treated with FT819 for SLE at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. Each patient presented with active lupus nephritis (LN) despite having been treated with multiple standard-of-care therapies and received flu-free conditioning followed by a single dose of FT819 at 360 million cells. As of a data cutoff date of December 4, 2024, there were no dose-limiting toxicities (DLTs), and no events of any grade of cytokine release syndrome (CRS), immune effector-cell associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GvHD). All three patients showed rapid, deep, and sustained elimination of CD19+ B cells in the periphery during the first month of treatment. The first and only patient eligible for disease assessment at six-month follow-up as of the data cutoff date achieved DORIS (Definition Of Remission In SLE) clinical remission and was free of all immunosuppressive therapy.
•
First Patient Treated with FT819 as Add-on to Maintenance Therapy. The Company amended the clinical protocol of its FT819 Phase 1 study to include a new treatment arm to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE. The first patient in the new arm was on a stable dose of oral mycophenolate mofetil (MMF) and was treated with a single dose of FT819 at 360 million cells without administration of any conditioning chemotherapy. There were no DLTs and no events of CRS, ICANS, or GvHD. The patient remains on-study.
•
Completed Type D Meeting with FDA for Inclusion of Additional Diseases in FT819 Phase 1 Study. In December 2024, the Company reached an agreement with the U.S. Food and Drug Administration (FDA) to allow for the clinical investigation of additional B cell-mediated autoimmune diseases under our current Phase 1 clinical trial of FT819. As a follow-up to the meeting, the Company has submitted an amended clinical protocol to the FDA that enables the conduct of independent dose-expansion cohorts for SLE as well as anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The Company plans to initiate dose-expansion cohorts in one or more of AAV, IIM, and SSc in 2025. Additionally, the FDA agreed to allow for investigation of a multi-dose treatment cycle as well as for re-treatment upon disease progression, making the treatment dosing paradigm more aligned with traditional biological therapies. The FDA also permitted the expansion of study eligibility criteria, including the inclusion of patients between the ages of 12 and 17.

FT825 / ONO-8250 iPSC-derived CAR T-cell Program

•
First Patient Treated with FT825 / ONO-8250 in Combination with Monoclonal Antibody Therapy. Under its collaboration with Ono Pharmaceutical Co., Ltd. (Ono), the Company is conducting a multi-center, Phase 1 study to assess the safety, pharmacokinetics, and activity of FT825 / ONO-8250, a multiplexed-engineered CAR T-cell product candidate targeting human epidermal growth factor receptor 2 (HER2), in patients with advanced solid tumors (NCT06241456). Enrollment is currently ongoing at the third dose level of 900 million cells as monotherapy and at the second dose level of 300 million cells in combination with epidermal growth factor receptor (EGFR)-targeted monoclonal antibody therapy.
•
Initial Phase 1 Clinical Data Presented at 2024 SITC (Free SITC Whitepaper). At the 2024 Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November, the Company presented initial clinical data from three heavily pre-treated patients, all of whom were previously treated with at least five prior lines of therapy including HER2-targeted therapy. Each patient was administered conditioning chemotherapy and a single dose of FT825 / ONO-8250 as monotherapy at the first dose level of 100 million cells. As of a data cutoff date of October 25, 2024, FT825 / ONO-8250 demonstrated a favorable safety profile with no DLTs and no events of any grade of CRS, ICANS, or GvHD. In addition, at Day 8 following treatment, peak CAR T-cell expansion was observed and phenotyping of FT825 / ONO-8250 sourced from the patients’ peripheral blood was indicative of an activated state (as evidenced by high levels of Granzyme B expression and maintenance of CAR expression) with no evidence of exhaustion (as evidenced by low levels of PD-1 and TIM3 expression).

FT522 iPSC-derived CAR NK Cell Program

•
Initial Translational Data of FT522 without Conditioning Chemotherapy Presented at ACR Convergence. FT522 is the Company’s off-the-shelf, CD19-targeted CAR NK cell product candidate and first product candidate to incorporate Alloimmune Defense Receptor (ADR) technology, which is designed to reduce or eliminate the need for administration of conditioning chemotherapy to patients receiving cell therapies. In November 2024, the Company presented initial translational data from its ongoing multi-center, Phase 1 clinical trial of FT522 in patients with relapsed / refractory B-cell lymphoma (BCL) (NCT05950334). The presentation illustrated that live FT522 cells with anti-B cell activity were detected in the patients’ peripheral blood through Day 15, demonstrating the potential of FT522 to persist and function in the presence of an unmatched, fully-intact immune system. The Company intends to assess any further clinical development of FT522 in relapsed / refractory BCL upon completion of dose escalation at the second dose level of 900 million cells.
•
Unique Clinical Development Opportunities for FT522 in Autoimmunity under Evaluation. The FDA has allowed the Company’s Investigational New Drug (IND) application to assess the safety, pharmacokinetics, and activity of FT522 across a basket of B cell-mediated autoimmune diseases. The Phase 1 clinical protocol allows for treatment of patients with up to four weekly doses of FT522, without administration of conditioning chemotherapy, as an add-on to rituximab induction therapy (Regimen A) and as an add-on to maintenance therapy in combination with rituximab (Regimen B). The Company is currently evaluating opportunities and timelines for the clinical development of FT522 in autoimmunity.

Fourth Quarter 2024 Financial Results

•
Cash & Investment Position: Cash, cash equivalents, and investments as of December 31, 2024 were $306.7 million.
•
Total Revenue: Revenue was $1.9 million for the fourth quarter of 2024, which was derived from the conduct of preclinical development activities for a second collaboration candidate targeting an undisclosed solid tumor antigen under the Company’s collaboration with Ono Pharmaceutical.
•
Total Operating Expenses: Total operating expenses were $63.6 million for the fourth quarter of 2024, including research and development expenses of $33.6 million and general and administrative expenses of $15.3 million. Such amount included $9.1 million of non-cash stock-based compensation expense and a one-time non-cash asset impairment charge of $14.7 million related to equipment and right-of-use assets.
•
Shares Outstanding: As of December 31, 2024, common shares outstanding were 113.9 million, pre-funded warrants outstanding were 3.9 million, and preferred shares outstanding were 2.8 million. Each preferred share is convertible into five common shares.

On March 5, 2025 Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, reported results for the full year and net sales for the fourth quarter of 2024 (Press release, Sandoz, MAR 5, 2025, View Source [SID1234650889]).

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KEY FULL-YEAR FIGURES

Change %
USD millions unless indicated otherwise 2024 2023 USD cc
Generics 7,504 7,432 1 2
Biosimilars 2,853 2,215 29 30
Net sales to third parties 10,357 9,647 7 9
Operating income 307 375 (18) 5
Net income 1 80 (99) nm
Diluted earnings per share (USD) 0.00 0.18 nm nm

Core results
Core EBITDA 2,080 1,743 19 24
Core EBITDA margin (%) 20.1 18.1
Core net income 1,176 953 23 28
Core diluted earnings per share (USD) 2.71 2.20 23 28
Management free cash flow 1,112 99
Net debt to core EBITDA ratio 1.6x 1.8x
Core ROIC (%) 12.3 9.8

nm = not meaningful

Richard Saynor, CEO of Sandoz, said: "We delivered strong results in our first full year as an independent company. At the same time, we made excellent progress in transforming the business, providing sustainable platforms for future growth, while all three regions grew net sales. We produced strong double-digit biosimilars sales growth in both the full year and fourth quarter, with generics growth accelerating in the second half. We also expanded our core EBITDA margin for the full year, driven by the strength of our biosimilars and increasing operating leverage. This was further helped by the transformation program launched in early 2024.

"As we look to 2025, we expect the positive momentum in the business to continue. We anticipate contribution from several exciting biosimilar launches, including Pyzchiva and Tyruko in the US and Wyost/Jubbonti in Europe and the US. These will add to an already-growing in-market portfolio and contribute to margin expansion. In addition, we will continue to build on our industry-leading pipeline across generics and biosimilars. Our 2025 guidance and mid-term outlook reflect the confidence we have in the strategic roadmap, our ability to expand patient access further, as well as the many attractive opportunities ahead."

2024 STRATEGIC PROGRESS

2024 saw a number of biosimilar launches, beginning in January, when Tyruko (natalizumab) was launched in Germany. The product was available in 11 markets by the end of the year and is ramping up steadily. In April, Sandoz leveraged a private-label agreement in the US to accelerate patient switching to its biosimilar; Hyrimoz (adalimumab) is now the leading adalimumab biosimilar in the US market. In July, the Company launched Pyzchiva (ustekinumab) in Europe and, by the end of the year, the product had been rolled out in 20 markets and took a leading share of the ustekinumab biosimilar market.

Sandoz became the leading biosimilars provider on a worldwide basis. Moving up to #3 in the US during the period, the Company reaffirms its ambition to occupy the leading position in that market. The Company added five assets to its industry-leading biosimilars pipeline, which now comprises 28 molecules. Pembrolizumab and nivolumab, two oncology assets addressing more than USD 40 billion of loss-of-exclusivity value, entered late-stage clinical trials. Around 450 generic pipeline products, in addition to its 28 biosimilars, support the goal of sustainable long-term growth.

Sandoz also made good progress on simplifying the business and adapting its processes. It achieved its planned reduction to 15 internal manufacturing sites, while increasing capacity at its remaining sites through extensions and efficiencies. The Company also made further headway in its consolidation of external suppliers, with the exit of around 100 finished-dosage-form suppliers ongoing and a similar number identified. Finally, Sandoz initiated a transformation program to make its organization more agile, simpler and more efficient.

GUIDANCE: 2025

The Company anticipates further major biosimilar launches in 2025, including Pyzchiva and Tyruko in the US, as well as Wyost/Jubbonti (denosumab) in Europe and the US. Price erosion is expected to return to normalized levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion by focusing on product mix, simplification of its external network and its ongoing transformation program. As a result, Sandoz expects, in FY 2025:

net sales to grow by a mid-single digit percentage in constant currencies
a core EBITDA margin of around 21%
The guidance excludes any impacts of unforeseen events or unconfirmed developments. This includes potential trade tariffs emanating from the US government.

MID-TERM OUTLOOK

Reaffirming its mid-term outlook to 2028, the Company expects:

net sales to grow annually by mid-single digit in constant currencies
the core EBITDA margin to increase to 24-26%
the annual dividend to represent 30-40% of full-year core net income
FOURTH-QUARTER AND FULL-YEAR SALES

Net sales for the fourth quarter were USD 2.7 billion, up by 9% in constant currencies. Volume contributed eight percentage points of growth, with the balance reflecting favorable pricing. Strong double-digit growth in biosimilars was driven by recent launches and strong momentum in the base business, while generics delivered solid growth that reflected recent launches.

Net sales for the full year were USD 10.4 billion, up by 9% in constant currencies. Volume contributed 10 percentage points of growth, partly offset by price erosion of one percentage point. The growth in sales primarily reflected the strong double-digit performance in biosimilars, continued demand in the base business, new launches in the US and Europe, as well as the acquisition of Cimerli in the US.

Net sales by business

Change % Change %
USD millions unless indicated otherwise Q4 2024 Q4 2023 USD cc* FY 2024 FY 2023 USD cc*
Generics 1,946 1,920 1 4 7,504 7,432 1 2
Biosimilars 769 623 23 25 2,853 2,215 29 30
Net sales to third parties 2,715 2,543 7 9 10,357 9,647 7 9

* In constant currencies

Generics overview
Net sales for the fourth quarter were USD 1.9 billion, up by 4% in constant currencies. Net sales for the full year were USD 7.5 billion, up by 2% in constant currencies.

Growth in Europe accelerated in the second half of the year, mainly driven by recent launches. Strong momentum also continued in the International region, reflecting favorable pricing dynamics and demand for antifungal agent Mycamine, partly offset by the divestment in the year of the Sandoz Chinese business. The decline in North America generics sales was due to price erosion on the mature products portfolio in the US, partly offset by new launches in the fourth quarter in the US.

Biosimilars overview
Net sales for the fourth quarter were USD 769 million, up 25% in constant currencies. Net sales for the full year were USD 2.9 billion, up 30% in constant currencies. The biosimilars share of total net sales increased from 23% in FY 2023 to 28% in FY 2024.

The strong double-digit biosimilars growth reflects the uptake of Hyrimoz in the US through the private- label agreement with Cordavis as well as the Sandoz Hyrimoz and unbranded adalimumab-adaz. In addition, the acquisition of Cimerli, the continued strong demand for the first-ever biosimilar, Omnitrope (somatropin), and the launches of Tyruko and Pyzchiva in Europe all contributed to the strong performance.

Net sales by region[5]

Change % Change %
USD millions unless indicated otherwise Q4 2024 Q4 2023 USD cc FY 2024 FY 2023 USD cc
Europe 1,367 1,272 7 8 5,363 5,023 7 6
North America 695 615 13 14 2,437 2,129 14 15
International 653 656 0 6 2,557 2,495 2 8
Net sales to third parties 2,715 2,543 7 9 10,357 9,647 7 9

Europe overview
Net sales for the fourth quarter were USD 1.4 billion, up 8% in constant currencies. Net sales for the full year were USD 5.4 billion, up 6% in constant currencies.

Strong growth in biosimilars continued, led by demand for Omnitrope and the contribution from the recent launch of Tyruko and Pyzchiva. Generics momentum accelerated in the second half of the year, driven by recent launches.

North America overview
Net sales for the fourth quarter were USD 695 million, up 14% in constant currencies. Net sales for the full year were USD 2.4 billion, up 15% in constant currencies.

Growth was driven by biosimilars with the ongoing uptake of Hyrimoz in the US, the acquisition of Cimerli, market share gains for Omnitrope in the US, and the launch of Wyost/Jubbonti in Canada. In generics, price erosion on the mature portfolio in the US was partly offset by new launches in the fourth quarter, including paclitaxel.

International overview
Net sales for the fourth quarter were USD 653 million, up 6% in constant currencies. Net sales for the full year were USD 2.6 billion, up 8% in constant currencies.

This was primarily a result of strong volume growth across both generics and biosimilars, the contribution from the acquisition of Mycamine in the prior year, favorable price dynamics and recent launches, partly offset by the divestment of the Chinese business in the second quarter.

OPERATING RESULTS

Change %
USD millions unless indicated otherwise 2024 2023 USD cc

Net sales to third parties 10,357 9,647 7 9
Gross profit 4,926 4,564 8 10
EBITDA 820 914 (10) (1)
Operating income 307 375 (18) 5

Core results
Core gross profit 5,253 4,913 7 9
% of net sales to third parties 50.7 50.9
Core EBITDA 2,080 1,743 19 24
% of net sales to third parties 20.1 18.1
Core operating income 1,821 1,488 22 28
% of net sales to third parties 17.6 15.4

Core gross profit amounted to USD 5.3 billion compared to USD 4.9 billion in the prior year, resulting in a core gross profit margin of 50.7% compared to 50.9% in 2023. Adjusted for sales to the former parent, the core gross profit margin was 49.4% in 2023. The favorable product mix from strong double-digit biosimilars growth and operational improvements was partly offset by price erosion and inflation on cost of goods sold, which impacted the results in the first half of 2024.

Core EBITDA was USD 2.1 billion versus USD 1.7 billion in the prior year, resulting in a core EBITDA margin of 20.1% compared to 18.1% in 2023. Adjusted for sales to the former parent and the ramp-up of standalone costs, the core EBITDA margin was 16.9% in 2023. The strong increase was driven by improvement in core gross profit margin, leveraging expenses from a growing topline and initial savings from our transformation program.

EBITDA was USD 820 million versus USD 914 million in the prior year. Core adjustments for EBITDA in 2024 were USD 1.3 billion compared to USD 829 million in 2023. These were mainly driven by separation costs of USD 348 million, transformation costs of USD 233 million and costs of rationalization of internal manufacturing sites of USD 78 million. In addition, adjustments for legal costs of USD 598 million were mainly driven by the legacy US generic antitrust class action litigation.

NON-OPERATING RESULTS

Change %
USD millions unless indicated otherwise 2024 2023 USD cc

Net financial result (318) (245) (30) (41)
Income taxes 12 (50) nm nm
Net income 1 80 nm nm
Diluted earnings per share (USD) 0.00 0.18 nm nm

Core results
Core net financial results (325) (251) (29) (41)
Core income taxes (320) (284) (13) (17)
Core effective tax rate (%) 21.4 23.0
Core net income 1,176 953 23 28
Core diluted earnings per share (USD) 2.71 2.20 23 28

nm = not meaningful

The core net financial result was an expense of USD 325 million compared to an expense of USD 251 million in 2023. The increase was primarily a result of our new standalone financing structure following the spin-off from our former parent and net currency result.

The core effective tax rate was 21.4% compared to 23.0% in the prior year, mainly driven by the geographical allocation of pre-tax income and losses.

Core net income was USD 1.2 billion, compared to USD 953 million in the prior year, mainly driven by a higher core operating income, partly offset by a higher core net financial result and core income taxes.

Core diluted earnings per share were USD 2.71, compared to USD 2.20 in the prior year. The weighted average number of shares diluted was 434.0 million in 2024.

CASH FLOW

Change
USD millions 2024 2023 in USD

Net cash flow from operating activities 656 362 294
Cash flows used for net CAPEX (554) (586) 32
Free cash flow 98 (234) 332
Management free cash flow 1,112 99 1,013

The Company generated net cash flows from operating activities of USD 656 million, compared with USD 362 million in the prior year. This was driven by working capital enhancements through improvements in receivables and a lower rate of increase in inventories following the spin-off from our former parent, partly offset by two deposited settlement amounts relating to the legacy US legal matters.

Cash flows used for capital expenditures (CAPEX) were USD 554 million compared to USD 586 million in the prior year. This includes investments in our new biosimilars facility in Slovenia and new development capabilities in Slovenia and Germany, as well as separation-related investments in facilities and technology. These investments are mainly focused on meeting growing demand for our current and future biosimilars and include a new biosimilar production plant in Lendava, Slovenia, and investments in the Sandoz antibiotics network in Kundl, Austria.

Free cash flow was USD 98 million compared to negative USD 234 million in the prior year. The improvement was mainly due to net cash flows from operating activities.

Management free cash flow, defined as free cash flow adjusted for one-off items, was USD 1.1 billion, a USD 1.0 billion improvement compared to USD 99 million in the prior year. The increase was mainly driven by higher core EBITDA and improvement in net working capital.

CAPITAL RESOURCES

December 31 Change
USD millions unless indicated otherwise 2024 2023 in USD

Inventories 2,800 2,700 100
Trade receivables 2,205 2,615 (410)
Trade payables 1,519 1,593 (74)
Net working capital 3,486 3,722 (236)
Total financial debts (incl. derivative financial instruments) 4,535 4,259 276
Cash and cash equivalents 1,191 1,109 82
Net debt 3,329 3,115 214
Net debt to core EBITDA ratio 1.6x 1.8x
Total equity 8,164 8,654 (490)
Core ROIC (%) 12.3 9.8

Net working capital decreased by USD 236 million compared to the prior year. Inventories increased by USD 100 million, mainly driven by the build-up for product launches and higher sales. Trade receivables decreased by USD 410 million while trade payables remained broadly in line with the prior year.

Total financial debts increased by USD 276 million, resulting mainly from the issuance of a EUR senior fixed rate note in September 2024 of EUR 600 million (USD 660 million), partly offset by favorable currency translation effects and repayments of local debt facilities.

Cash and cash equivalents increased by USD 82 million, mainly driven by net proceeds from the issuance of the senior fixed rate note and net cash flows from operating activities, partly offset by the first dividend payment of USD 215 million and the Cimerli acquisition of USD 188 million.

As a result, net debt increased to USD 3.3 billion on December 31, 2024 compared to USD 3.1 billion on December 31, 2023. Net debt to core EBITDA ratio decreased to 1.6 times on December 31, 2024, compared to 1.8 times in the prior year, reflecting the strong growth in core EBITDA in 2024.

Total equity decreased by USD 490 million. Net income of USD 1 million for the year was primarily offset by the dividend payment of USD 212 million and unfavorable currency-translation differences of USD 323 million.

Core ROIC was 12.3% versus 9.8% in the prior year, driven mainly by strong growth in core operating income.

DIVIDEND

The Board of Directors recommends a dividend of CHF 0.60 per share, representing 24% of core net income in line with Company guidance. This represents a CHF 0.15 per share increase compared to prior year. Shareholders will vote on this proposal at the Annual General Meeting on April 15, 2025.

INTEGRATED ANNUAL REPORT

The Company published its 2024 Integrated Annual Report today, which can be found online here.

KEY LINKS

Webcast – Live at 9am CET, March 5, 2025.
Analyst call presentation
Analyst consensus

CALENDAR

Sandoz will hold its Annual General Meeting on April 15, 2025. The Company intends to publish its first-quarter sales update on April 30, 2025.

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 2024 Integrated Annual Report.

On March 5, 2025 Orion and Aiforia reported the extension of their collaboration to include the use of Aiforia’s software solution for preclinical study evaluations (Press release, Orion, MAY 3, 2025, View Source [SID1234650908]). This collaboration involves implementing the AiforiaStudies module within Orion’s preclinical histology processes, as well as joint development to further automate and improve the study evaluation workflow of preclinical pathologists.

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"We are extremely pleased to expand our collaboration with Orion. The AiforiaStudies module is specifically designed for the needs of the pharmaceutical industry and their preclinical histology studies. It is exciting to collaborate with this innovative pharmaceutical company to gain valuable insights into their requirements and further develop our offering for this sector. Through this collaboration, we will strengthen our preclinical portfolio that already spans from the discovery phase to safety studies, seamlessly integrating with our AI-based image analysis tools," says Jukka Tapaninen, CEO of Aiforia.

"We are thrilled to deepen our partnership with Aiforia; the AiforiaStudies module aligns perfectly with our commitment to advancing pharmaceutical research and development. By leveraging Aiforia’s AI-based image analysis and reporting tools, we expect faster and more efficient pathological evaluations, reducing the time required from pathologists to assess sample slides and improving the accuracy of our preclinical studies. We look forward to the valuable insights and advancements this partnership will bring", says Riikka Oksala, Director, DMPK & Safety Sciences, R&D, Orion.