Novartis continues strong momentum of sales growth with margin expansion, reaches key innovation milestones in 2024

On January 30, 2025 Novartis reported strong momentum of sales growth with margin expansion, reaches key innovation milestones in 2024 (Press release, Novartis, JAN 30, 2025, View Source [SID1234649967]).

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Full year

Net sales grew +12% (cc1, +11% USD) with core operating income1 up +22% (cc, +19% USD)
Sales growth driven by continued strong performance from Entresto (+31% cc), Cosentyx (+25% cc), Kesimpta (+49% cc), Kisqali (+49% cc), Pluvicto (+42% cc) and Leqvio (+114% cc)
Core operating income margin1 38.7%, +330 basis points (cc), mainly driven by higher net sales
Operating income grew +55% (cc, +49% USD); net income up +45% (cc, +39% USD)
Core EPS1 grew +24% (cc, +21% USD) to USD 7.81
Free cash flow1 of USD 16.3 billion (+24% USD) driven by higher net cash flows from operating activities
Fourth quarter

Net sales grew +16% (cc, +15% USD) with core operating income up +29% (cc, +27% USD)
Sales growth driven by continued strong performance from Entresto (+34% cc), Kesimpta (+49% cc), Kisqali (+52% cc), Cosentyx (+24% cc), and Leqvio (+83% cc)
Selected innovation milestones:
Scemblix FDA accelerated approval for 1L Ph+ CML-CP
Kisqali EC approval for HR+/HER2- stage II and III eBC
Fabhalta (iptacopan) FDA submission for C3G; priority review granted
OAV101 IT Phase III STEER study positive readout in SMA
Dividend, 2025 guidance

Dividend of CHF 3.50 per share, an increase of 6.1%, proposed for 2024
2025 guidance2 – Net sales expected to grow mid- to high-single digit and core operating income expected to grow high single to low double-digit
Basel, January 31, 2025 – commenting on Q4 2024 results, Vas Narasimhan, CEO of Novartis, said:
"In our first full year as a pure-play innovative medicines company, Novartis delivered one of the strongest financial performances in our history, growing sales 12% cc and core operating income 22% cc. We also achieved important innovation milestones, including new approvals and readouts for many of the assets that will fuel our growth over the mid- to long-term. With the momentum we are seeing in the business, we expect to continue our strong sales growth with margin expansion in 2025 and we remain on track to deliver on our mid-term guidance. Looking ahead, we are focused on executing against our pipeline, including 15 submission-enabling readouts over the coming years and more than 30 assets with the potential to drive differentiated growth over the long term. We remain balanced in our capital allocation approach and committed to creating sustainable value for shareholders."

Key figures Continuing operations3
Q4 2024 Q4 2023 % change FY 2024 FY 2023 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 13 153 11 423 15 16 50 317 45 440 11 12
Operating income 3 530 2 582 37 39 14 544 9 769 49 55
Net income 2 820 2 638 7 6 11 939 8 572 39 45
EPS (USD) 1.42 1.29 10 10 5.92 4.13 43 49
Free cash flow 3 635 2 141 70 16 253 13 160 24
Core operating income 4 859 3 821 27 29 19 494 16 372 19 22
Core net income 3 933 3 126 26 29 15 755 13 446 17 21
Core EPS (USD) 1.98 1.53 29 33 7.81 6.47 21 24
1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 47 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7.
3. As defined on page 35 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities, and Discontinued operations include operational results from the Sandoz business.

Strategy

Our focus

In 2023, Novartis completed its transformation into a "pure-play" innovative medicines business. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy and xRNA) are being prioritized for continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities

Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society.
Financials

Following the September 15, 2023, shareholder approval of the spin-off of Sandoz, Novartis reported its consolidated financial statements as "continuing operations" and "discontinued operations."

Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off.

While the commentary below focuses on continuing operations, we also provide information on discontinued operations.

Continuing operations

Fourth quarter

Net sales were USD 13.2 billion (+15%, +16% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 1 percentage point and pricing had a positive impact of 2 percentage points, benefiting from revenue deduction adjustments mainly in the US.

Operating income was USD 3.5 billion (+37%, +39% cc), mainly driven by higher net sales, partly offset by higher R&D investments.

Net income was USD 2.8 billion (+7%, +6% cc), mainly driven by higher operating income, partly offset by higher income taxes, mainly resulting from higher income before taxes in the current year and non-recurring tax benefits in the prior year. EPS was USD 1.42 (+10%, +10% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 4.9 billion (+27%, +29% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 36.9% of net sales, increasing 3.4 percentage points (+3.7 percentage points cc).

Core net income was USD 3.9 billion (+26%, +29% cc), mainly due to higher core operating income. Core EPS was USD 1.98 (+29%, +33% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow from continuing operations amounted to USD 3.6 billion (+70% USD), compared with USD 2.1 billion in the prior-year quarter, driven by higher net cash flows from operating activities from continuing operations.

Full year

Net sales were USD 50.3 billion (+11%, +12% cc), with volume contributing 14 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing was flat.

Operating income was USD 14.5 billion (+49%, +55% cc), mainly driven by higher net sales, lower impairments, amortization and restructuring charges, partly offset by prior-year one-time income from legal matters and higher R&D investments.

Net income was USD 11.9 billion (+39%, +45% cc), mainly driven by higher operating income, partly offset by higher income taxes, mainly resulting from higher income before taxes in the current year and non-recurring tax benefits in the prior year. EPS was USD 5.92 (+43%, +49% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 19.5 billion (+19%, +22% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 38.7% of net sales, increasing 2.7 percentage points (+3.3 percentage points cc).

Core net income was USD 15.8 billion (+17%, +21% cc), mainly due to higher core operating income. Core EPS was USD 7.81 (+21%, +24% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow from continuing operations amounted to USD 16.3 billion (+24% USD), compared with USD 13.2 billion in 2023, driven by higher net cash flows from operating activities from continuing operations.

Discontinued operations

Discontinued operations include the Sandoz generic pharmaceuticals and biosimilars division, certain corporate activities attributable to Sandoz and certain other expenses related to the spin-off of the Sandoz business.

Fourth quarter

As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the fourth quarter of 2024 and 2023 related to discontinued operations. In the fourth quarter of 2023, net income from discontinued operations amounted to USD 5.8 billion, driven by the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders of USD 5.9 billion. For further details see Note 3 "Significant acquisitions of businesses and spin-off of Sandoz business" and Note 11 "Discontinued operations" to the condensed consolidated financial statements.

Full year

As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in 2024 related to discontinued operations. In 2023, discontinued operations net sales were USD 7.4 billion, operating income amounted to USD 265 million and net income from discontinued operations was USD 6.3 billion driven by the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders, which amounted to USD 5.9 billion. For further details see Note 3 "Significant acquisitions of businesses and spin-off of Sandoz business" and Note 11 "Discontinued operations" to the condensed consolidated financial statements.

Total Company

Fourth quarter

Total Company net income was USD 2.8 billion in 2024, compared with USD 8.5 billion in 2023 and basic EPS was USD 1.42 compared to USD 4.14 in the prior year quarter as the prior year quarter included the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders, which amounted to USD 5.9 billion. Net cash flows from operating activities for total Company amounted to USD 4.2 billion and free cash flow amounted to USD 3.6 billion.

Full year

Total Company net income was USD 11.9 billion in 2024, compared with USD 14.9 billion in 2023 and basic EPS was USD 5.92 compared to USD 7.15 in the prior year as the prior year included the IFRS Accounting Standards non-cash, non-taxable, net gain on distribution of Sandoz Group AG to Novartis AG shareholders, which amounted to USD 5.9 billion. Net cash flows from operating activities for total Company amounted to USD 17.6 billion and free cash flow amounted to USD 16.3 billion.

Q4 key growth drivers

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q4 growth) including:

Entresto (USD 2 180 million, +34% cc) sustained robust, demand-led growth, with increased penetration in the US and Europe following guideline-directed medical therapy in heart failure, and in China and Japan with increased penetration in hypertension
Kesimpta (USD 950 million, +49% cc) sales grew across all regions reflecting increased demand for a high efficacy product with convenient self-administered dosing
Kisqali (USD 902 million, +52% cc) sales grew strongly across all regions, including +66% (cc) growth in the US with strong momentum from the recently launched early breast cancer (eBC) indication. Kisqali growth is underpinned by increasing recognition of its overall survival benefit in HR+/HER2- metastatic breast cancer (mBC) as well as Category 1 NCCN Guidelines recommendation in both mBC and eBC
Cosentyx (USD 1 596 million, +24% cc) sales grew mainly in the US, Europe and emerging growth markets driven by recent launches (including the HS indication and the IV formulation in the US) and volume growth in core indications
Leqvio (USD 223 million, +83% cc) continued to show steady growth, with a focus on increasing account and patient adoption, and continuing medical education
Scemblix (USD 207 million, +66% cc) sales grew across all regions demonstrating the continued high unmet need in CML
Pluvicto (USD 351 million, +28% cc) sales grew in Europe and in the US. With supply now unconstrained, the focus is on increasing share in established RLT sites while opening new sites and referral pathways and initiating new patients
Fabhalta (USD 57 million) launch continues with a modest ramp in PNH globally and in IgA nephropathy in the US
Jakavi (USD 487 million, +13% cc) sales grew across all regions driven by strong demand across indications
Tafinlar + Mekinist (USD 527 million, +10% cc) sales grew mainly in the US, Japan and emerging growth markets driven by increased demand
Lutathera (USD 190 million, +30% cc) sales grew across all regions due to increased demand and earlier line adoption (within indication) in the US and Japan
Ilaris (USD 413 million, +11% cc) sales grew across all regions, led by the US
Xolair (USD 399 million, +9% cc) grew mainly in emerging growth markets
Emerging growth markets* Grew +9% (cc) overall. China grew +7% (cc) to USD 0.8 billion, mainly driven by Entresto, Xolair and Kisqali
*All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand

Net sales of the top 20 brands in the fourth quarter and full year

Q4 2024 % change FY 2024 % change
USD m USD cc USD m USD cc
Entresto 2 180 33 34 7 822 30 31
Cosentyx 1 596 22 24 6 141 23 25
Kesimpta 950 48 49 3 224 49 49
Kisqali 902 48 52 3 033 46 49
Promacta/Revolade 583 4 5 2 216 -2 -1
Tafinlar + Mekinist 527 8 10 2 058 7 9
Jakavi 487 10 13 1 936 13 15
Tasigna 411 -8 -6 1 671 -10 -8
Xolair 399 6 9 1 643 12 15
Ilaris 413 10 11 1 509 11 14
Pluvicto 351 29 28 1 392 42 42
Sandostatin Group 306 -3 -1 1 279 -3 -1
Zolgensma 262 -8 -6 1 214 0 2
Lucentis 210 -30 -29 1 044 -29 -28
Leqvio 223 81 83 754 112 114
Lutathera 190 29 30 724 20 20
Exforge Group 159 2 8 703 -1 2
Scemblix 207 66 66 689 67 68
Galvus Group 144 -6 2 602 -13 -6
Diovan Group 140 -5 -2 590 -4 0
Top 20 brands total 10 640 19 21 40 244 18 19
R&D update – key developments from the fourth quarter

New approvals

Scemblix
(asciminib) FDA granted accelerated approval to Scemblix for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The FDA also broadened the indication for Scemblix to include adult patients with previously treated Ph+ CML-CP.
Kisqali
(ribociclib) EC approved Kisqali as an adjuvant treatment in combination with an aromatase inhibitor for patients with HR+/HER2- early breast cancer (eBC) at high risk of recurrence regardless of nodal status, nearly doubling the eligible population.
Regulatory updates

Fabhalta
(iptacopan) Submission for the treatment of C3 glomerulopathy (C3G) was completed in the US, and the FDA granted Priority Review status to Fabhalta in this indication. The FDA also confirmed no need for an Advisory Committee meeting.
Results from ongoing trials and other highlights

OAV101 IT
(onasemnogene abeparvovec) Novartis announced positive topline results from the Phase III STEER study. This pivotal trial assessed the efficacy and safety of investigational intrathecal OAV101 in treatment-naïve patients with spinal muscular atrophy (SMA) Type 2, aged two to less than 18 years who are able to sit but have never walked independently. The study met its primary endpoint showing an increase from baseline across the study population in total Hammersmith Functional Motor Scale – Expanded (HFMSE) scores. HFMSE is a gold standard for SMA-specific assessment of motor ability and disease progression.
Pluvicto
(lutetium Lu177 vipivotide tetraxetan) Final overall survival (OS) analysis in the Phase III PSMAfore study in pre-taxane mCRPC demonstrated an OS hazard ratio less than 1.0 (HR<1.0) in the intent-to-treat (ITT) population unadjusted for cross-over. These results have been shared with the FDA as part of their ongoing review of Pluvicto in this indication.
Kisqali
(ribociclib) Results from an updated analysis of the pivotal Phase III NATALEE trial of Kisqali plus endocrine therapy (ET) in patients with HR+/HER2- stage II and III eBC showed a sustained reduction in distant recurrence of 28.5% compared to ET alone, underscoring Kisqali’s extended efficacy beyond its 3-year treatment duration. No new safety signals were identified. Data presented at SABCS.

In addition, Kisqali was recognized by NCCN Guidelines as a Category 1 preferred therapy in combination with an aromatase inhibitor for patients with HR+/HER2- eBC. Kisqali is the only Category 1 preferred CDK4/6 inhibitor recommended for both all node-positive disease as well as node-negative disease with high-risk disease characteristics. Kisqali also achieved the highest score (A) on the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) for eBC, while maintaining a rating of 5 and 4 in the mBC setting.

In January 2025, Novartis settled compound patent litigation with a generic manufacturer, supporting Kisqali US patent protection until at least Q1 2031.
Scemblix
(asciminib) 96-week results from the Phase III ASC4FIRST trial with Scemblix showed sustained superior major molecular response vs. all investigator-selected standard-of-care TKIs (imatinib, nilotinib, dasatinib and bosutinib) and vs. imatinib alone in adult patients with newly diagnosed Ph+ CML-CP. Fewer treatment-related grade ≥3 AEs and half the rate of AEs leading to treatment discontinuation were reported for Scemblix vs. both imatinib and second-generation TKIs. Data presented at ASH (Free ASH Whitepaper).
Fabhalta
(iptacopan) In the Phase III APPEAR-C3G study, patients with C3G treated with oral Fabhalta in addition to supportive care experienced clinically meaningful proteinuria reduction sustained at 12 months. In addition, in the open-label period of the study, proteinuria reduction was seen in participants switched to Fabhalta, and improvement in estimated glomerular filtration rate (eGFR) slope was observed upon Fabhalta initiation compared to patients’ historic rapid decline. Fabhalta continued to show a favorable safety profile. Data presented at ASN.
Selected transactions Novartis entered into a global license and collaboration agreement with PTC Therapeutics for PTC518, a HTT mRNA splice modulator with the potential to become the first oral disease-modifying therapy for Huntington’s disease. Under the agreement, Novartis will assume responsibility for PTC518’s development, manufacturing and commercialization following the completion of the placebo-controlled portion of the ongoing Phase II PIVOT-HD study, expected in H1 2025.

Novartis acquired Kate Therapeutics, a preclinical-stage biotechnology company focused on developing adeno-associated virus (AAV)-based gene therapies to treat genetically defined neuromuscular diseases. The acquisition will strengthen Novartis’ efforts to advance gene therapies and neuroscience innovation and includes enabling technology platforms and several preclinical therapeutic candidates.

Novartis entered into a worldwide licensing and collaboration agreement with Ratio Therapeutics for a next-generation SSTR2-targeting radiotherapeutic candidate. The collaboration focuses on preclinical research and selection of an SSTR2-targeting development candidate, after which Novartis will lead development, manufacturing and commercialization.
Capital structure and net debt

Retaining a good balance between investment in the business, a strong capital structure, and attractive shareholder returns remains a priority.

In 2024, Novartis repurchased a total of 77.5 million shares for USD 8.3 billion on the SIX Swiss Exchange second trading line. These purchases included 68.8 million shares (USD 7.3 billion) under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 5.4 billion still to be executed). In addition, 8.7 million shares (USD 1.0 billion) were repurchased to mitigate the impact of share deliveries under the equity-based compensation plans for employees. Furthermore, 1.2 million shares (equity value of USD 0.1 billion) were repurchased from employees. In the same period, 9.8 million shares (equity value of USD 1.1 billion) were delivered to employees related to equity-based compensation plans. Consequently, the total number of shares outstanding decreased by 68.9 million versus December 31, 2023. These treasury share transactions resulted in an equity decrease of USD 7.4 billion and a net cash outflow of USD 8.3 billion.

Net debt increased to USD 16.1 billion at December 31, 2024, compared to USD 10.2 billion net debt at December 31, 2023. The increase was mainly due to the free cash flow of USD 16.3 billion being more than offset by the cash outflows for treasury share transactions of USD 8.3 billion, the annual dividend payment of USD 7.6 billion, and net cash outflow for M&A / intangible assets transactions of USD 6.3 billion.

As of Q4 2024, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2025 outlook

Barring unforeseen events; growth vs prior year in cc
Net sales Expected to grow mid- to high-single digit
Core operating income Expected to grow high single to low double-digit
Key assumptions:

We assume Tasigna, Promacta and Entresto US generic entry mid-2025 for forecasting purposes
Foreign exchange impact

If late-January exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be negative 2 percentage points on net sales and negative 3 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Annual General Meeting

Dividend Proposal

The Novartis Board of Directors proposes a dividend payment of CHF 3.50 per share for 2024, up 6.1% from CHF 3.30 per share in the prior year, representing the 28th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the AGM on March 7, 2025.

Reduction in Share Capital

The Novartis Board of Directors proposes to cancel 77 508 630 shares (8 548 613 shares repurchased under the authorization of March 4, 2022, and 68 960 017 shares repurchased under the authorization of March 7, 2023) and to reduce the share capital accordingly by CHF 38.0 million, from CHF 1 073 065 943.53 to CHF
1 035 086 714.83.

Potential Further Share Repurchases

As of December 31, 2024, the remaining available amount under the existing shareholder authority granted at the 2023 AGM is CHF 3.5 billion. To allow for the full execution of the already announced share buyback of up to USD 15 billion and potential additional share buybacks, the Board of Directors proposes that shareholders, in addition to the remaining authorization of CHF 3.5 billion, authorize the Board of Directors to repurchase shares as deemed appropriate from time to time up to CHF 10 billion between the 2025 AGM and 2028 AGM.

Elections of the Board Chair and the Members of the Board of Directors

Dr. Joerg Reinhardt, Dr. Charles Sawyers and Mr. William Winters are not standing for re-election. The Board of Directors and the Executive Committee of Novartis thank them for their many years of valuable service as Chair and members of the Board of Directors.

The Board of Directors proposes the election of Dr. Giovanni Caforio as member of the Board of Directors and Board Chair. Dr. Caforio has had an international career in the healthcare industry spanning more than 35 years, most recently as the Chairman and CEO of Bristol Myers Squibb (BMS).

In addition, the Board of Directors proposes the re-election of the current members of the Board of Directors with the exception of Dr. Reinhardt, Dr. Sawyers and Mr. Winters, and the election of Dr. Elizabeth McNally as a new member of the Board of Directors, each until the end of the next Annual General Meeting.

Key figures1

Continuing operations2 Q4 2024 Q4 2023 % change FY 2024 FY 2023 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 13 153 11 423 15 16 50 317 45 440 11 12
Operating income 3 530 2 582 37 39 14 544 9 769 49 55
As a % of sales 26.8 22.6 28.9 21.5
Net income 2 820 2 638 7 6 11 939 8 572 39 45
EPS (USD) 1.42 1.29 10 10 5.92 4.13 43 49
Cash flows from
operating activities 4 193 2 547 65 17 619 14 220 24
Non-IFRS measures
Free cash flow 3 635 2 141 70 16 253 13 160 24
Core operating income 4 859 3 821 27 29 19 494 16 372 19 22
As a % of sales 36.9 33.5 38.7 36.0
Core net income 3 933 3 126 26 29 15 755 13 446 17 21
Core EPS (USD) 1.98 1.53 29 33 7.81 6.47 21 24



Discontinued operations2 Q4 2024 Q4 2023 % change FY 2024 FY 2023 % change
USD m USD m USD cc USD m USD m USD cc
Net sales nm nm 7 428 nm nm
Operating income nm nm 265 nm nm
As a % of sales 3.6
Net income 5 842 nm nm 6 282 nm nm
Non-IFRS measures
Core operating income nm nm 1 185 nm nm
As a % of sales 16.0
Core net income nm nm 889 nm nm



Total Company Q4 2024 Q4 2023 % change FY 2024 FY 2023 % change
USD m USD m USD cc USD m USD m USD cc
Net income 2 820 8 480 nm nm 11 939 14 854 nm nm
EPS (USD) 1.42 4.14 nm nm 5.92 7.15 nm nm
Cash flows from
operating activities 4 193 2 547 nm nm 17 619 14 458 nm nm
Non-IFRS measures
Free cash flow 3 635 2 141 nm nm 16 253 13 179 nm nm
Core net income 3 933 3 126 nm nm 15 755 14 335 nm nm
Core EPS (USD) 1.98 1.53 nm nm 7.81 6.90 nm nm

nm= not meaningful
1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 47 of the Condensed Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.
2. As defined on page 35 of the Condensed Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities, and Discontinued operations include operational results from the Sandoz business.

Detailed financial results accompanying this press release are included in the Condensed Financial Report at the link below:
View Source

UroGen Pharma to Present at Upcoming Investor Conferences

On January 30, 2025 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it will participate at the following investor conferences in February (Press release, UroGen Pharma, JAN 30, 2025, View Source [SID1234649966]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Guggenheim Securities SMID Cap Biotech Conference


Date / Time:

February 5, 2025 at 10:30 AM ET


Format:

Presentation and 1×1 investor meetings


Location:

New York, NY


Webcast Link:

here

Oppenheimer 35th Annual Healthcare Life Sciences Conference


Date / Time:

February 11, 2025 at 1:20 PM ET


Format:

Presentation and 1×1 investor meetings


Location:

Virtual


Webcast Link:

here

Webcasts from the conferences will also be available on UroGen’s Investor Relations website. A replay will be available on the site for approximately 90 days.

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2024 Results

On January 30, 2025 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Thermo Fisher Scientific, JAN 30, 2025, View Source [SID1234649965]).

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fourth Quarter and Full Year 2024 Highlights

•Fourth quarter revenue grew 5% to $11.40 billion.
•Fourth quarter GAAP diluted earnings per share (EPS) grew 14% to $4.78.
•Fourth quarter adjusted EPS grew 8% to $6.10.

•Full year revenue was $42.88 billion, flat versus prior year.
•Full year GAAP diluted earnings per share (EPS) grew 7% to $16.53.
•Full year adjusted EPS grew 1% to $21.86.

•Further strengthened our industry leadership throughout the year by advancing our trusted partner status with customers, gaining market share and delivering differentiated financial performance, including strong revenue and earnings growth in the fourth quarter.

•Advanced our proven growth strategy, launching a range of high-impact, innovative new products in 2024, highlighted by the groundbreaking Thermo Scientific Iliad (Scanning) Transmission Electron Microscope, the Thermo Scientific Stellar mass spectrometer, the Thermo Scientific Dionex Inuvion Ion Chromatography system, and the Applied Biosystems MagMAX Sequential DNA/RNA kit. During the fourth quarter, we launched the Thermo Scientific iCAP MX Series ICP-MS, an inductively coupled mass spectrometry platform designed to streamline trace elemental analysis for environmental, food, industrial and research laboratories; and new additions to the Gibco CTS Detachable Dynabeads platform to further enhance cell therapy development and production.

•Continued to strengthen our industry-leading commercial engine and deepen our trusted partner status with customers to accelerate their innovation and enhance their productivity. Highlights included the introduction of Accelerator Drug Development in the fourth quarter. This integrated offering combines our unique expertise and capabilities in clinical research services and contract manufacturing to streamline the drug development process, enabling increased speed, simplicity and scalability, helping our customers to improve the return on their R&D investments. During the year, we also continued to expand collaborations with our customers, highlighted by the recently announced partnership with the University of Arkansas for Medical Sciences (UAMS) to establish the Thermo Fisher Scientific Center of Excellence for Proteomics at UAMS and, earlier in the year, the partnership with the National Cancer Institute on the myeloMATCH precision medicine umbrella trial.

•Continued to successfully execute our capital deployment strategy in 2024. During the year we completed the acquisition of Olink, a leading provider of advanced solutions for proteomics research. Additionally in the year, we returned $4.6 billion of capital to shareholders through stock buybacks and dividends.

"We finished 2024 with excellent financial performance, delivering strong growth on the top and bottom line in the fourth quarter," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We drove meaningful share gain and enabled the success of our customers, by leveraging our proven growth strategy and PPI Business System, capping off another year of differentiated performance."

Casper added, "We are in a great position to deliver excellent performance in 2025 as we continue to create value for all of our stakeholders and build an even brighter future for our company."

Fourth Quarter 2024

Revenue for the quarter grew 5% to $11.40 billion in 2024 versus $10.89 billion in the same quarter of 2023. Organic revenue growth was 4% and Core organic revenue growth was 5%.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter of 2024 was $4.78, versus $4.20 in the same quarter last year. GAAP operating income for the fourth quarter of 2024 was $2.02 billion, compared with $1.85 billion in the year-ago quarter. GAAP operating margin was 17.7%, compared with 17.0% in the fourth quarter of 2023.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2024 was $6.10, versus $5.67 in the fourth quarter of 2023. Adjusted operating income for the fourth quarter of 2024 was $2.72 billion, compared with $2.55 billion in the year-ago quarter. Adjusted operating margin was 23.9%, compared with 23.4% in the fourth quarter of 2023.

Full Year 2024

Revenue for the full year was $42.88 billion in 2024 versus $42.86 billion in 2023. Organic revenue and Core organic revenue growth were flat.

GAAP Earnings Results

Full year GAAP diluted EPS was $16.53, versus $15.45 in 2023. GAAP operating income for the full year 2024 was $7.34 billion, compared with $6.86 billion in 2023. GAAP operating margin was 17.1%, compared with 16.0% for 2023.

Non-GAAP Earnings Results

Adjusted EPS for the full year 2024 was $21.86, versus $21.55 for 2023. Adjusted operating income for the full year was $9.71 billion, compared with $9.81 billion in 2023. Adjusted operating margin was 22.6%, compared with 22.9% in 2023.

Annual Guidance for 2025

The company will provide 2025 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Note on Presentation
Certain amounts and percentages reported within this press release are presented and calculated based on underlying unrounded amounts. As a result, the sum of components may not equal corresponding totals due to rounding.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, January 30, 2025 at 8:30 a.m. Eastern Time. During the call, the company will discuss its financial performance, as well as future expectations. To listen, call (833) 470-1428 within the U.S. or (404) 975-4839 outside the U.S. The access code is 706921. You may also listen to the call live on the "Investors" section of our website, www.thermofisher.com. The earnings press release and related information can also be found in that section of our website under the heading "Financials". A replay of the call will be available under "News, Events & Presentations" through February 13, 2025.

Sanofi: Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025

On January 30, 2025 Sanofi reported Q4 sales growth of 10.3%, 2024 business EPS guidance exceeded, and strong business EPS rebound expected in 2025 (Press release, Sanofi, JAN 30, 2025, View Source [SID1234649963]).

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Q4: sales growth of 10.3% at CER1 and business EPS2 of €1.31
•Pharma launches up 56.5%, reaching sales of €0.8 billion, 8% of total sales, led by ALTUVIIIO
•Dupixent sales up 16.0% to €3.5 billion
•Vaccines sales up 10.8% to €2.2 billion, driven by Beyfortus sales in Europe
•Business EPS of €1.31, -11.0% at CER and -14.9% reported; IFRS EPS of €0.54
FY: double-digit sales growth and business EPS guidance exceeded
•Sales totaled €41.1 billion, an increase of 11.3% at CER
•Sales targets exceeded: Dupixent >€13 billion and Beyfortus blockbuster status (€1.7 billion) in its first full year
•Research and Development expenses reached €7.4 billion, up 14.6%, in line with commitments
•Business EPS of €7.12, +4.1% at CER, above guidance, and -1.8% reported; IFRS EPS of €4.59
•The Board of Directors met on January 29, 2025; proposes a dividend of €3.92 for 2024, 30th year of consecutive increases
Pipeline: increased investment and progress
•Q4: four regulatory approvals: Dupixent EoE (children) (EU), Kevzara PMR (EU), Cerdelga GD1 (children) (EU), Efluelda flu (JP)3
•FY: 14 regulatory approvals of medicines and vaccines, 21 regulatory submission acceptances, and eight positive phase 3 readouts emphasize a positive and improving pipeline momentum
Further progress towards a focused biopharma business
•Intention to sell a controlling stake in Opella consumer health at an attractive valuation; closing in Q2 2025 at the earliest4
Guidance
•In 2025, sales are anticipated to grow by a mid-to-high single-digit percentage at CER5. Sanofi confirms the expectation of a strong rebound in business EPS with growth at a low double-digit percentage at CER (before share buyback).6
•Sanofi intends to execute a share buyback program in 2025 of €5 billion. Shares will be purchased preferably through block trades and in the open market with the purpose of cancellation.
Paul Hudson, Chief Executive Officer: "We achieved double-digit sales growth in 2024 while pursuing the transformation of the company. Innovation was a key driver of our growth as launches already contributed 11 percent of sales, with Beyfortus becoming a blockbuster in its first full year of sales. We exceeded our business EPS guidance. In 2024, we announced an intention to sell a controlling stake in Opella consumer health, which will make Sanofi a focused, science-driven biopharma company. We increased R&D investments and achieved significant progress with our pipeline in 2024, including positive phase 3 study results for new medicines such as rilzabrutinib in rare diseases and tolebrutinib in multiple sclerosis. As we enter 2025, we expect continued, solid growth in sales and a strong rebound in earnings. We are also confident in the mid to long-term growth prospects of Sanofi, supported by ongoing launches, Dupixent (currently expected to reach sales of around €22 billion in 20307, in line with the current ambition), and expected future launches from our pipeline."

Q4 2024 Change Change
at CER FY 2024 Change Change
at CER
IFRS net sales reported €10,564 m +9.1 % +10.3 % €41,081 m +8.6 % +11.3 %
IFRS net income reported €683 m — — €5,744 m +6.4 % —
IFRS EPS reported €0.54 — — €4.59 +6.5 % —
Free cash flow8 €2,340 m -25.5 % — €5,955 m -19.6 % —
Business operating income €2,078 m -11.8 % -7.7 % €11,343 m +1.5 % +7.6 %
Business net income €1,642 m -15.1 % -11.2 % €8,912 m -1.8 % +4.1 %
Business EPS €1.31 -14.9 % -11.0 % €7.12 -1.8 % +4.1 %

Q4 and FY 2024 summary
A conference call and webcast for investors and analysts will begin at 15:00 CET. Details can be accessed via sanofi.com, including presentation slides.

The performance shown in this press release covers the three-month period to December 31, 2024 (the quarter or Q4 2024) and the 12-month period to December 31, 2024 (the year or FY 2024) compared to the three-month period to December 31, 2023 (Q4 2023) and the 12-month period to December 31, 2023 (FY 2023) respectively. All percentage changes in sales in this press release are at CER and the commentary below emphasizes the recent quarterly performance, unless stated otherwise.

In Q4 2024, sales were €10,564 million and increased by 10.3%. Exchange rate movements had a negative effect of 1.2 percentage points (pp); therefore, as reported, sales increased by 9.1%. The divestments of medicines/portfolio streamlining had a negative impact of 0.6pp.
In FY 2024, sales were €41,081 million and increased by 11.3%. Exchange rate movements had a negative effect of 2.7pp; therefore, as reported, sales increased by 8.6%. The divestments of medicines/portfolio streamlining had a negative impact of 0.7pp.
Sales by geography
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
United States 5,151 +13.3 % 19,986 +16.2 %
Europe 2,433 +6.0 % 9,027 +2.3 %
Rest of World 2,980 +8.8 % 12,068 +10.7 %
of which China 549 -10.4 % 2,666 -0.5 %

US sales were €5,151 million and increased by 13.3%. The strong performance was driven by launches, including Beyfortus, and by Dupixent and Lantus. Other main medicines, and vaccines excluding Beyfortus had slightly lower sales during the quarter.
Europe sales were €2,433 million and increased by 6.0%. Growth was driven by Beyfortus, Dupixent and pharma launches. Other medicines, including Aubagio which faced generic competition, and flu vaccines all had lower sales during Q4.
Rest of World sales were €2,980 million and increased by 8.8%. The performance was led by Dupixent, Beyfortus, PPH and booster vaccines, and pharma launches offset by flu vaccines and legacy medicines, including Plavix. China sales were €549 million and decreased by 10.4%, generally impacted by one-off inventory effects ahead of upcoming changes to the national reimbursement drug list and volume-based procurement. In the year, China sales were broadly stable. Hyperinflation in Argentina contributed 1.8pp to the total Sanofi growth rate in the quarter and 1.4pp in the year.
Business operating income
In Q4 2024, business operating income (BOI) was €2,078 million and decreased by 7.7% (-11.8% reported). The ratio of BOI to net sales was 20.4% and decreased by 3.9pp (19.7% reported, down by 4.6pp). This decrease was mainly driven by a lower gross margin and higher R&D expenses. In FY 2024, BOI was €11,343 million and increased by 7.6% (+1.5% reported). The ratio of BOI to net sales was 28.6% and decreased by 1.0pp (27.6% reported, down by 2.0pp).
Business development
Business development, including strategic investments in external innovation is an integrated part of Sanofi’s efforts to continuously access optionality from new and promising scientific developments and platforms and replenish the pipeline.
In October, Sanofi made a strategic equity investment in Resalis Therapeutics, an Italian company dedicated to developing RNA-based therapies that tackle the root causes of complex metabolic disorders. Sanofi also participated in a €82 million series D financing of Agomab, a Belgian company focused on achieving disease modification by modulating fibrosis and regeneration in chronic indications such as fibrostenosing Crohn’s disease and idiopathic pulmonary fibrosis.
In November, Sanofi made a strategic investment in Zucara, a Canadian company, as part of a $20 million series B financing. As part of the agreement, Sanofi will receive an exclusive right of first negotiation.
In November, Recordati announced the closing of the acquisition of global rights to Enjaymo. Enjaymo is a targeted, biologic medicine approved in the US, the EU and Japan for the treatment of cold agglutinin disease, a rare lymphoproliferative disease.

Biopharma segment
Pharma
Pharma launches
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
ALTUVIIIO 230 +143.6 % 682 +330.2 %
Nexviazyme/Nexviadyme
184 +42.0 % 667 +61.2 %
Rezurock 132 +53.5 % 470 +51.6 %
Sarclisa 130 +30.1 % 471 +29.7 %
Cablivi 73 +24.1 % 249 +9.7 %
Xenpozyme 38 +50.0 % 151 +68.1 %
Enjaymo
22 -8.7 % 105 +48.6 %
Tzield 18 +80.0 % 54 +116.0 %
Total 827 +56.5 % 2,849 +71.4 %

ALTUVIIIO (hemophilia A) sales were €230 million of which more than 85% were in the US. Growth continued to be driven by patient switches from older factor medicines and an increasing percentage from non-factor treatments. Rest of World sales of €32 million benefited from supply sales for the ongoing launch of Altuvoct in countries served by Sobi. The hemophilia A franchise (ALTUVIIIO and Eloctate) sales were €311 million and increased by 57.4% as fewer patients switch away from Eloctate.
Nexviazyme/Nexviadyme (Pompe disease) sales were €184 million and increased by 42.0%, driven by Europe (+68.6%) and Rest of World (+55.0%). In the US (+26.3%), most patients have already converted from Myozyme/Lumizyme. The Pompe disease franchise (Nexviazyme/Nexviadyme and Myozyme/Lumizyme) sales were €316 million and increased by 9.7%.
Rezurock (chronic graft-versus-host disease) sales were €132 million and increased by 53.5%, driven by the US (+43.4%) and by launches in Europe (sales of €8 million) and in Rest of World (sales of €5 million).
Sarclisa (multiple myeloma) sales were €130 million and increased by 30.1%, driven by increased use in earlier lines of treatment, mainly in second-line combination treatment, and market share gains in general, in Europe and in Rest of World, including Japan.
Cablivi (acquired thrombotic thrombocytopenic purpura) sales were €73 million and increased by 24.1%, driven by an increased number of patients being identified for appropriate treatment, in the US and from launches in Europe and in Rest of World.
Xenpozyme (acid sphingomyelinase deficiency) sales were €38 million and increased by 50.0%, driven by an increased number of patients being identified for appropriate treatment across all geographies.
Enjaymo (cold agglutinin disease) sales were €22 million and decreased by 8.7%. On November 29, 2024, Recordati announced the closing of the acquisition of global rights to Enjaymo at which point Sanofi stopped booking in-market sales of the medicine.
Tzield (delay onset of type 1 diabetes) sales were €18 million, a sequential increase from Q3 2024 of €3 million, reflecting continued growth in patients and infusions supported by ongoing efforts to increase awareness and screening.
Immunology
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
Dupixent 3,458 +16.0 % 13,072 +23.1 %

Dupixent sales were €3,458 million and increased by 16.0%. In the US, sales were €2,551 million and increased by 10.4%. Growth was driven by continued strong prescription trends in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis. The launch in COPD has initiated and is expected to gain momentum in 2025. Sales growth was impacted by fewer business days in Q4 2024 compared to prior periods and a year-end gross-to-net adjustment. In Europe, Dupixent sales were €431 million and increased by 30.4% reflecting continued growth in all approved indications. Following the July 2024 EU approval in COPD, Europe benefited from initial sales in Germany while reimbursement decisions are anticipated throughout Europe in 2025. In Rest of World, sales were €476 million and increased by 38.1%, driven mainly by sales in Japan. In FY 2024, Dupixent sales were €13,072 million and increased by 23.1%, exceeding the target of around €13 billion in sales in 2024 at constant exchange rates.
SANOFI PRESS RELEASE Q4 2024
3

Other main medicines
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
Lantus 439 +63.4 % 1,628 +20.8 %
Toujeo 290 +6.5 % 1,227 +13.4 %
Fabrazyme 269 +12.4 % 1,047 +9.1 %
Lovenox 231 -7.6 % 982 -7.0 %
Plavix 211 -16.9 % 914 -0.4 %
Cerezyme 171 +33.8 % 742 +20.3 %
Alprolix 169 +19.0 % 588 +9.6 %
Myozyme/Lumizyme 132 -17.0 % 671 -12.3 %
Thymoglobulin 125 +15.2 % 492 +7.3 %
Praluent 110 -6.8 % 483 +15.2 %
Cerdelga 87 +16.0 % 333 +12.8 %
Eloctate 81 -21.4 % 368 -20.8 %
Aubagio 78 -35.5 % 379 -59.4 %

Lantus sales were €439 million and increased by 63.4%. US sales were €193 million and benefited from a lower base of comparison from a net-price adjustment in the prior period and another quarter of windfall sales due to the continued unavailability of a competing medicine. In 2025, customer demand is expected to normalize and windfall sales to reduce as well.
Toujeo sales were €290 million and increased by 6.5%, mainly driven by Europe (+10.1%) and Rest of World (+7.4%) where Toujeo continued to increase its basal insulin market share. US sales declined slightly (-4.3%) as windfall sales started to subside.
Fabrazyme sales were €269 million and increased by 12.4%, mainly driven by growth in the number of patients and improved treatment compliance.
Lovenox sales were €231 million and decreased by 7.6%, reflecting the continued impact from volume-based procurement in China and biosimilar competition in Europe.
Plavix sales were €211 million and decreased by 16.9%, reflecting renewal of volume-based procurement in China and market volatility in Japan.
Cerezyme sales were €171 million and increased by 33.8%, driven by growth in the number of patients in Rest of World as well as an element of high-inflation boost from Argentina. The Gaucher disease franchise (Cerezyme and Cerdelga) sales were €258 million and increased by 27.4%.
Alprolix sales were €169 million and increased by 19.0%, benefiting from an increase in US market share and supply sales to Sobi.
Myozyme/Lumizyme sales were €132 million and decreased by 17.0% due to the aforesaid shift to Nexviazyme/Nexviadyme.
Thymoglobulin sales were €125 million and increased by 15.2%, reflecting increased sales in the US and in Rest of World.
Praluent sales were €110 million and decreased by 6.8%, reflecting lower sales in Rest of World, specifically in China.
Cerdelga sales were €87 million and increased by 16.0%, primarily driven by a higher number of patients and volume in the US.
Eloctate sales were €81 million and decreased by 21.4%, mainly due to patients converting to ALTUVIIIO in the US and in Japan.
Aubagio sales were €78 million and decreased by 35.5%, reflecting the loss of exclusivity starting in the US in March 2023 followed by the EU in September 2023. Aubagio sales are expected to continue to decrease albeit at a slower rate.
Vaccines
Net sales
(€ million)
Q4 2024 Change
at CER FY 2024 Change
at CER
RSV (Beyfortus) 841 +106.6 % 1,686 +214.4 %
Polio/Pertussis/Hib vaccines and boosters 632 +10.8 % 2,741 +1.2 %
Influenza vaccines 454 -36.8 % 2,555 -1.3 %
Meningitis, Travel and endemic vaccines 249 -4.2 % 1,316 +5.4 %
Total 2,177 +10.8 % 8,299 +13.5 %

Vaccines sales were €2,177 million and increased by 10.8%, driven by continued Beyfortus roll-out, mostly in Europe. In FY 2024, sales were €8,299 million and increased by 13.5%. This performance was driven by a successful roll-out of Beyfortus, reaching €1.7 billion in sales, partly offset by the absence of COVID-19 sales compared to €226 million in FY 2023.
Beyfortus sales were €841 million, driven by additional sales in Europe, in particular Germany, and in the US. Beyfortus is now protecting babies in more than 20 countries. The continued successful roll-out was enabled by additional manufacturing capacity approved during the second half-year of 2024.
Polio/Pertussis/Hib (PPH) and booster vaccines sales were €632 million and increased by 10.8%, driven by increased booster demand in several countries to re-vaccinate adolescents and adults.
Influenza vaccines sales were €454 million and decreased by 36.8%, due to earlier deliveries in Q3 2024 compared to last year.

Meningitis, Travel and endemic vaccines sales were €249 million and decreased by 4.2%, reflecting unfavorable US Centers for Disease Control and Prevention buying patterns partly offset by continued MenQuadfi roll-out in Europe and Rest of World.
Biopharma business operating income
In Q4 2024, Biopharma BOI was €2,038 million and decreased by 8.9% (-13.0% reported). The ratio of BOI to net sales was 20.0% and decreased by 4.2pp (19.3% reported, down by 4.9pp). This decrease was mainly driven by a lower gross margin and higher R&D expenses. In FY 2024, BOI was €11,285 million and increased by 7.3% (+1.2% reported). The ratio of BOI to net sales was 28.4% and decreased by 1.1pp (27.5% reported, down by 2.0pp).
Pipeline update
Sanofi has 83 projects in a pipeline across four main disease areas (Immunology, Rare diseases, Neurology, and Oncology) and Vaccines, including 38 potential new medicines (NMEs) and vaccines (NVEs). The following section highlights significant developments in the late- and mid-stage pipeline in the quarter:
Highlights
Regulatory approvals Dupixent – EoE (children) (EU)
Kevzara – Polymyalgia rheumatica (PMR) (EU)
Cerdelga – GD1 (children) (EU)
Efluelda – Influenza (JP)
Regulatory submissions/acceptances1
Dupixent – CSU (US)
Dupixent – BP (US1)
rilzabrutinib – ITP (US, EU, CN)
Tzield – DO (EU)
Tzield – EI (EU)
tolebrutinib – SPMS (US1)
Sarclisa – NDMM, TE (HD7 study) (EU)
Phase 3 study starts Fluzone HD – Flu (50 years+)
SP0202 – Pneumococcal disease
Dupixent – Lichen simplex chronicus

Immunology
Dupixent (dupilumab)
•Following the adoption of a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use, the EU approved Dupixent to treat eosinophilic esophagitis (EoE) in children as young as one year of age. The approval covers children aged one to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The approval is based on the two-part (Part A and B) EoE KIDS phase 3 study (clinical study identifier: NCT04394351). This expands the initial approval in the EU for EoE in adults and adolescents and makes Dupixent the first and only medicine indicated to treat these young patients.
•The US Food and Drug Administration (FDA) accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target action date for the FDA decision is April 18, 2025.
•Regeneron announced that the sBLA for Dupixent to treat adults with moderate-to-severe bullous pemphigoid (BP) had been submitted to the FDA. BP is a chronic and relapsing disease characterized by intense itch and blisters, reddening of the skin, and painful chronic lesions. The blisters and rash can form over much of the body and cause the skin to bleed and crust, resulting in patients being more prone to infection and affecting their daily functioning. Regeneron and Sanofi are awaiting regulatory submission acceptance in the US.
•The STYLE 1 (clinical study identifier: NCT06687967) and STYLE 2 (clinical study identifier: NCT06687980) phase 3 studies of Dupixent compared with placebo in patients with lichen simplex chronicus commenced dosing the first patient.
duvakitug (TL1A mAb)
The RELIEVE UCCD phase 2b study (clinical study identifier: NCT05499130) met its primary endpoints in patients with ulcerative colitis (UC) and Crohn’s disease (CD). RELIEVE UCCD assessed duvakitug, a human IgG1-λ2 monoclonal antibody targeting TL1A, for the treatment of moderate-to-severe inflammatory bowel disease. In the study, 36.2% (low dose) and 47.8% (high dose) of patients with UC treated with duvakitug achieved clinical remission compared to 20.4% on placebo, placebo-adjusted rates were 15.7% (low dose) and 27.4% (high dose), at week 14 (p=0.050 and 0.003, respectively). In patients with CD, 26.1% (low dose) and 47.8% (high dose) treated with duvakitug achieved endoscopic response compared to 13.0% on placebo, placebo-adjusted rates were 13.0% (low dose) and 34.8% (high dose), at week 14 (p=0.058 and <0.001, respectively). Overall, the treatment effect was consistent across subgroups. This is the first and only randomized, placebo-controlled study to evaluate the impact of an anti-TL1A monoclonal antibody in CD. Detailed results are expected to be presented at the 20th Congress of the European Crohn’s and Colitis Organisation in February 2025.

Tzield (teplizumab)
The EMA accepted for review the regulatory submission for Tzield in children and adolescents to delay the onset (DO) of stage 3 type 1 diabetes (T1D) as well as for the early intervention (EI) of stage 3 T1D. Tzield is approved in the US to delay the onset of stage 3 T1D.
balinatunfib (oral TNFR1si)
The SPECIFY-CD phase 2 study (clinical study identifier: NCT06637631) of balinatunfib compared with placebo in adults with moderate-to-severe CD commenced dosing the first patient.
lunsekimig (IL13xTSLP Nanobody VHH)
The AIRLYMPUS phase 2 study (clinical study identifier: NCT06676319) of subcutaneous lunsekimig compared with placebo as an add-on therapy in high-risk asthma adults not currently eligible for biologic treatments commenced dosing the first patient.
Rare diseases
rilzabrutinib (BTK inhibitor)
•Positive results from the LUNA 3 phase 3 study (clinical study identifier: NCT04562766) of rilzabrutinib in adults with persistent or chronic immune thrombocytopenia (ITP), a rare immune-mediated disease, were presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego, US. The primary endpoint was met, with rilzabrutinib demonstrating durable platelet response in 23% of ITP adult patients compared to 0% on the placebo arm (p<0.0001). Platelet response was achieved in 65% (n=86) of patients receiving rilzabrutinib compared to 33% (n=23) of patients on placebo. Other key secondary endpoints were met including reduced bleeding, number of weeks with platelet response, the need for rescue therapy use, and improved physical fatigue and quality of life measures. Rilzabrutinib is under regulatory review in the EU, China, and the US with a target date for the FDA decision of August 29, 2025.
•During the quarter, the 52-week open-label two-cohort phase 2 study (clinical study identifier: NCT04520451) of rilzabrutinib in IgG4-related disease showed considerable outcomes on disease flare and glucocorticoid sparing. Data are planned to be shared at a medical meeting later this year.
Cerdelga (eliglustat)
Cerdelga was approved in the EU for the treatment of children with Gaucher disease type 1 (GD1), expanding the current use in adults.
Neurology
tolebrutinib (BTK inhibitor)
The FDA granted breakthrough-therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This is based on positive results from the HERCULES phase 3 study (clinical study identifier: NCT04411641), demonstrating that tolebrutinib delayed the time to onset of 6-month confirmed disability progression by 31% compared to placebo (HR 0.69; 95% CI 0.55-0.88; p=0.0026), with further analysis of secondary endpoints demonstrating that the number of participants who experienced confirmed disability improvement was nearly double with tolebrutinib (10%) compared to those on placebo (5%) (HR 1.88; 95% CI 1.10-3.21; nominal p=0.021). Sanofi is awaiting regulatory submission acceptance in the US with an EU submission anticipated during H1 2025.
The PERSEUS phase 3 study in primary progressive MS (PPMS) is ongoing with study results anticipated in H2 2025 (clinical study identifier: NCT04458051).
Oncology
Sarclisa (isatuximab)
The EMA accepted for review the regulatory submission for Sarclisa in combination with lenalidomide, bortezomib, and dexamethasone (RVd) induction therapy in transplant-eligible, newly diagnosed multiple myeloma (NDMM, TE) based on the GMMG-HD7 phase 3 study (clinical study identifier: NCT03617731). In the study, Sarclisa significantly prolonged progression-free survival from first randomization, resulting in a statistically significant and clinically meaningful 30% reduction in disease progression or death, compared to RVd induction regardless of the maintenance regimen (HR 0.70; 95% CI 0.52-0.95; stratified log-rank p=0.0184).
Vaccines
SP0202 (PCV21)
A phase 3 program (clinical study identifier: NCT06736041) was initiated for SP0202, a 21-valent pneumococcal conjugate vaccine (PCV21). SP0202 is the first pneumococcal conjugate vaccine candidate with more than 20 serotypes to enter phase 3 in infants and toddlers. The phase 3 program will include more than 7,700 infants, toddlers, young children, and adolescents across multiple geographies, including in the US, Europe, Australia, Asia, and Latin America. In addition, Sanofi and SK bioscience expanded the agreement to develop, license and commercialize next-generation PCVs for both pediatric and adult populations. Despite decades of public health vaccination programs, invasive pneumococcal disease continues to inflict a substantial burden of disease, primarily due to Streptococcus pneumoniae serotypes that are not included in currently available conjugate vaccines. Next-generation PCVs have the potential to extend vaccine coverage of disease-causing serotypes.
SANOFI PRESS RELEASE Q4 2024
6

SP0178 (Fluzone HD)
The vaccine candidate is in development to prevent influenza infections in people aged 50 to 64 years. A phase 3 study (clinical study identifier: NCT06641180) commenced dosing the first patient.
SP0287 (Fluzone HD/Flublok and Nuvaxovid)
The FDA granted fast-track designation to two combination vaccine candidates to prevent influenza and COVID-19 infections in people 50 years of age and older. Both candidates combine two already licensed and authorized vaccines with proven efficacy through randomized controlled studies, and with favorable tolerability.
The first combination vaccine candidate (clinical study identifier: NCT06695117) consists of the inactivated flu vaccine Fluzone High-Dose combined with the adjuvanted recombinant Nuvaxovid COVID-19 vaccine. The second candidate (clinical study identifier: NCT06695130) combines the recombinant protein-based flu vaccine Flublok with Nuvaxovid. Two separate phase 1/2 studies have initiated.
SP0289 (flu H5 mRNA)
The FDA granted fast-track designation to the vaccine candidate to prevent pandemic influenza and a phase 1/2 study (clinical study identifier: NCT06727058) commenced dosing the first patient.
SP0256 (RSV+hMPV mRNA)
The FDA granted fast-track designation to the vaccine candidate to prevent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) infections in people aged 60 to 75 years. A phase 1/2 study (clinical study identifier: NCT06583031) is ongoing.
Anticipated major upcoming pipeline milestones
Medicine/vaccine Indication Description
H1 2025 Dupixent COPD Regulatory decision (JP)
CSU Regulatory decision (US, EU)
amlitelimab Asthma Phase 2 data
Hidradenitis suppurativa (HS) Phase 2 data
balinatunfib (oral TNFR1si) Psoriasis Phase 2 data
brivekimig (TNFaxOX40L) HS Phase 2 data
Cerezyme Gaucher disease type 3 (GD3) Regulatory submission (US)
rilzabrutinib ITP Regulatory submission (JP)
fitusiran Hemophilia A/B Regulatory decision (US)
tolebrutinib SPMS Regulatory submission (EU)
Sarclisa
NDMM, transplant ineligible (IMROZ study)
Regulatory decision (JP, CN)
Subcutaneous formulation Regulatory submission (US, EU)
SAR447873 Gastroenteropancreatic neuroendocrine tumors Phase 2 data (final)
MenQuadfi Meningitis (six weeks+) Regulatory decision (US)
SP0087 Rabies Phase 3 data

SANOFI PRESS RELEASE Q4 2024
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H2 2025 Dupixent BP Regulatory decision (US)
itepekimab COPD Phase 3 data
Regulatory submission (US, EU)
balinatunfib Rheumatoid arthritis Phase 2 data
Rezurock
Chronic graft-versus-host disease, third line
Regulatory decision (EU)
Tzield Delay onset of type 1 diabetes Regulatory decision (EU, CN)
Early intervention in type 1 diabetes Regulatory decision (EU)
rilzabrutinib ITP Regulatory decision (US, EU, CN)
fitusiran Hemophilia A/B Regulatory decision (CN)
venglustat Fabry disease (FD) Phase 3 data
GD3 Phase 3 data
SAR447537 Alpha-1 antitrypsin deficiency Phase 2 data
tolebrutinib SPMS Regulatory decision (US)
PPMS Phase 3 data
Sarclisa NDMM, TE (HD7) Regulatory decision (EU)
Subcutaneous formulation Regulatory submission (JP, CN)
SP0087 Rabies Regulatory submission (US, EU)
SP0230 Meningitis Phase 2 data
SP0256 RSV (older adults) Phase 2 data
Fluzone HD Influenza (50 years+) Phase 3 data
2026 itepekimab COPD Regulatory submission (JP, CN)
Bronchiectasis Phase 2 data
amlitelimab
Atopic dermatitis (AD)
Phase 3 data
lunsekimig Asthma Phase 2 data
Chronic rhinosinusitis with nasal polyps Phase 2 data
frexalimab
Systemic lupus erythematosus
Phase 2 data
eclitasertib
UC
Phase 2 data
SAR444656
HS
Phase 2 data
AD Phase 2 data
Nexviazyme Infantile-onset Pompe disease Phase 3 data
Regulatory submission
venglustat FD Regulatory submission
GD3 Regulatory submission
SAR447537 Alpha-1 antitrypsin deficiency Regulatory submission
tolebrutinib PPMS Regulatory submission (US, EU)
riliprubart Chronic inflammatory demyelinating polyradiculoneuropathy Phase 3 data
Regulatory submission
Fluzone HD Influenza (50 years+) Regulatory submission
SP0218
Yellow fever
Phase 3 data
Regulatory submission
SP0282 E. coli sepsis Phase 3 data
SP0125 RSV (toddlers) Phase 3 data

Corporate Social Responsibility update at the end of Q4 2024
Access
Sanofi is ranked 3rd in the 2024 Access to Medicine (ATM) Index
The ATM Index evaluates the efforts of 20 leading pharmaceutical companies in expanding access to essential medicines across low- and middle-income countries (LMICs). It measures progress across three critical areas: governance of access, research and development, and equitable product delivery.
In the 2024 ATM Index, Sanofi ranked third, significantly improving its performance from the previous edition of the index, where Sanofi was ranked eighth.
Sanofi’s performance reflects leadership in "governance of access", where Sanofi ranked first, with the integrated access-to-medicine strategy that is linked to leadership incentives and a clear methodology for tracking patient reach. Furthermore, Sanofi has consistently implemented structured access planning for projects in the pipeline. In addition, the vaccines portfolio, as well as the Global Health Unit (GHU) support equitable product delivery and capacity building initiatives that strengthen local healthcare systems. The GHU was also recognized as a best practice example for inclusive business models by the ATM Index report.
As an example, Sanofi concluded a manufacturing partnership with Biovac in South Africa in 2024, designed to enable regional manufacturing of polio vaccines to serve the potential needs of over 40 African countries. Sanofi will continue to produce the bulk of the Inactivated Polio Vaccine (IPV) and Biovac, who will hold the marketing authorization, will be responsible for final formulation, filling, packaging, and delivery of millions of IPV doses to UNICEF for countries supported by the Global Alliance for Vaccines and Immunization (GAVI) in Africa.
As showcased in its first Impact Report, the GHU significantly scaled its operations in 2024, delivering medicines from its Impact portfolio, a dedicated line of high-quality, affordable treatments for noncommunicable diseases (NCDs) to 30 LMICs. This includes life-saving treatments for diabetes, cardiovascular diseases, and cancer, with a clear goal to reach two million patients by 2030.
The GHU invests heavily in strengthening of health systems, from training healthcare workers to supporting infrastructure improvements. In Zanzibar, Sanofi worked with local organizations to deliver integrated care for cardio-metabolic diseases, using digital self-management tools and community health ambassadors to reach patients in remote areas. In Djibouti, Sanofi collaborated with the Ministry of Health to improve care for diabetes and hypertension through health worker training programs and supply chain optimization.
Since its launch, the GHU has:
•Reached over 790,000 patients with NCD treatments;
•Trained over 13,000 healthcare providers and community health workers in NCD management; and
•Supported 128 health facilities in optimizing access and availability of NCD treatments.

Q4 and FY 2024 financial results
Business net income1
Net sales were €10,564 million in Q4 2024 and increased by 9.1% (10.3% at CER). In FY 2024, net sales were €41,081 million and increased by 8.6% (11.3% at CER).
Other revenues were €856 million in Q4 2024 and decreased by 38.0% (37.9% at CER) due to COVID-19 revenue of €411 in Q4 2023. VaxServe sales of non-Sanofi products were €560 million and decreased by 21.2% (21.5% at CER). In FY 2024, other revenues were €3,205 million and decreased by 15.7% (13.3% at CER) due to COVID-19 revenue of €509 million in 2023. VaxServe sales of non-Sanofi products were €1,959 million and decreased by 9.6% (9.5% at CER). In addition, other revenues included sales of Opella products in certain markets (€339 million), supply sales to Opella (€163 million), royalties (€121 million) and others/manufacturing services (€623 million).
Gross profit was €7,844 million in Q4 2024 and increased by 5.4% (6.9% at CER). The gross margin was 74.3% and decreased by 2.5pp (74.5% at CER, down by 2.3pp). The lower gross margin was caused by the lack of COVID-19 other revenue in 2024. In FY 2024, the gross profit was €31,091 million and increased by 7.2% (10.3% at CER). The gross margin was 75.7% and decreased by 1.0pp (76.1% at CER, down by 0.6 pp). The lower gross margin was primarily due to the lack of COVID-19 other revenue in 2024.
Research and Development expenses were €2,257 million in Q4 2024 and increased by 24.4% (24.4% at CER). This reflected increased activity in mid- and late-stage development as several new medicines advanced to phase 3 studies or additional phase 2 studies were initiated in new indications. C.€60 million of the increase was from one-off costs associated with portfolio prioritization, including in oncology. The ratio of R&D to net sales was 21.4% and increased by 2.7pp. In FY 2024, R&D expenses were €7,394 million and increased by 13.6% (14.6% at CER). This increase reflected similar factors as mentioned above. The ratio of R&D to net sales was 18.0% and increased by 0.8pp.
Selling, general and administrative expenses were €2,648 million in Q4 2024 and increased by 7.4% (7.9% at CER), a moderate increase that still generated growth leverage. The ratio of SG&A to net sales was 25.1% and decreased by 0.4pp. In FY 2024, SG&A expenses were €9,183 million and increased by 2.8% (4.5% at CER). The ratio of SG&A to net sales was 22.4% and decreased by 1.2pp.
Total operating expenses were €4,905 million in Q4 2024 and increased by 14.6% (14.9% at CER). In FY 2024, total operating expenses were €16,577 million and increased by 7.4% (8.8% at CER).
Other operating income net of expenses was -€886 million in Q4 2024 compared to -€844 million in Q4 2023. Income included €179 million from divestments of medicines/portfolio streamlining, compared to €62 million in Q4 2023. The income was more than offset by an expense of €1,044 million from the share of profit in the Regeneron monoclonal antibody alliance compared to €889 million in Q4 2023. More details are in appendix 7. In FY 2024, other operating income net of expenses was -€3,293 million compared to -€2,464 million in 2023. Income from divestments was €394 million compared to €452 million in 2023. Expenses from the Regeneron monoclonal antibody alliance were €3,947 million compared to €3,196 million in FY 2023.
Share of profit from associates was €32 million in Q4 2024 compared to €41 million in Q4 2023 and included the share of US profit related to Vaxelis. In FY 2024, share of profit from associates was €136 million compared to €101 million in FY 2023.
Business operating income was €2,078 million in Q4 2024 and decreased by 11.8% (-7.7% at CER). The ratio of BOI to net sales was 19.7% and decreased by 4.6pp (20.4% at CER, down by 3.9pp). In FY 2024, BOI was €11,343 million and increased by 1.5% (+7.6% at CER). The ratio of BOI to net sales was 27.6% and decreased by 2.0pp (28.6% at CER, down by 1.0pp).
Net financial expenses were €62 million in Q4 2024 compared to €45 million in Q4 2023. In FY 2024, net financial expenses were €263 million compared to €168 million in FY 2023, reflecting increased net debt and higher average interest rates.
The effective tax rate increased to 18.8% in Q4 2024 from 16.5% in Q4 2023 and increased to 19.8% in FY 2024 from 17.7% in FY 2023. The effective tax rate has increased mainly due to the implementation of the Organisation for Economic Co-operation and Development Pillar Two rules.
Business net income was €1,642 million in Q4 2024 and decreased by 15.1% (-11.2% at CER). The ratio of business net income to net sales was 15.5% and decreased by 4.5pp (16.1% at CER, down by 3.9pp). In FY 2024, business net income was €8,912 million and decreased by 1.8% (+4.1% at CER). The ratio of business net income to net sales was 21.7% and decreased by 2.3pp (22.5% at CER, down by 1.5pp).
Business earnings per share (EPS) was €1.31 in Q4 2024 and decreased by 14.9% (-11.0% at CER). The average number of shares outstanding was 1,253.6 million compared to 1,253.6 million in Q4 2023. In FY 2024, business earnings per share was 7.12 and decreased by 1.8% (+4.1% at CER). The average number of shares outstanding was 1,251.4 million compared to 1,251.7 million in FY 2023.
Opella
Sanofi intends to sell a controlling stake in Opella consumer health to CD&R with a closing in Q2 2025 at the earliest. Sanofi will retain c.48% ownership.
In Q4 2024, and under the new scope of reporting, sales were €1,202 million and increased by 8% from €1,108 million in Q4 2023, primarily driven by the Wellness category (Qunol and Digestive). The Seasonal category remained stable in a lower Cough & Cold market. In FY 2024, also under the new scope of reporting, sales were €4,948 million and increased by 4% from €4,765 million in 2023. On January 21, 2025, Opella announced that the FDA had lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. This decision allows for the initiation of the AUT.

Appendix 1: Q4 2024 net sales by medicine/vaccine and geography
Q4 2024
(€ million)
Total sales
% CER % reported United States % CER Europe % CER Rest of World % CER
Immunology
Dupixent 3,458 +16.0 % +15.7 % 2,551 +10.4 % 431 +30.4 % 476 +38.1 %
Kevzara 126 +21.0 % +20.0 % 76 +24.6 % 32 +3.2 % 18 +46.2 %
Rare diseases
Fabrazyme 269 +12.4 % +11.2 % 139 +7.0 % 63 +5.0 % 67 +34.0 %
ALTUVIIIO (*) 230 +143.6 % +144.7 % 198 +114.1 % — — % 32 +1500.0 %
Nexviazyme/Nexviadyme (*) 184 +42.0 % +40.5 % 97 +26.3 % 59 +68.6 % 28 +55.0 %
Cerezyme 171 +33.8 % +28.6 % 48 — % 63 +16.7 % 60 +116.1 %
Alprolix 169 +19.0 % +19.0 % 129 +15.3 % — — % 40 +32.3 %
Myozyme 132 -17.0 % -17.0 % 49 -15.5 % 55 -28.6 % 28 +16.7 %
Cerdelga 87 +16.0 % +16.0 % 50 +19.0 % 32 +6.7 % 5 +66.7 %
Eloctate 81 -21.4 % -21.4 % 53 -23.2 % — — % 28 -17.6 %
Cablivi (*) 73 +24.1 % +25.9 % 42 +46.4 % 26 — % 5 +20.0 %
Aldurazyme 69 +16.1 % +11.3 % 18 +5.9 % 21 +4.8 % 30 +33.3 %
Xenpozyme (*) 38 +50.0 % +46.2 % 24 +41.2 % 8 +33.3 % 6 +133.3 %
Enjaymo (*) 22 -8.7 % -4.3 % 11 -7.7 % 3 +200.0 % 8 -33.3 %
Neurology
Aubagio 78 -35.5 % -35.5 % 42 -2.3 % 27 -61.4 % 9 +12.5 %
Oncology
Sarclisa (*) 130 +30.1 % +26.2 % 54 +20.0 % 36 +32.1 % 40 +43.3 %
Jevtana 77 +1.3 % +1.3 % 58 +3.6 % 2 — % 17 -5.3 %
Fasturtec 51 +27.5 % +27.5 % 34 +30.8 % 12 +20.0 % 5 +25.0 %
Other main medicines
Lantus 439 +63.4 % +59.1 % 193 +464.7 % 80 -3.6 % 166 +12.6 %
Toujeo 290 +6.5 % +4.3 % 46 -4.3 % 120 +10.1 % 124 +7.4 %
Lovenox 231 -7.6 % -12.2 % 2 +100.0 % 131 -12.7 % 98 -1.8 %
Plavix 211 -16.9 % -16.9 % 1 -50.0 % 22 -8.3 % 188 -17.5 %
Rezurock (*) 132 +53.5 % +53.5 % 119 +43.4 % 8 +300.0 % 5 +400.0 %
Thymoglobulin 125 +15.2 % +11.6 % 82 +14.3 % 10 — % 33 +21.2 %
Praluent 110 -6.8 % -6.8 % — — % 85 +6.3 % 25 -34.2 %
Aprovel 105 -0.9 % -0.9 % 1 — % 18 -10.0 % 86 +1.2 %
Multaq 77 -12.6 % -11.5 % 68 -12.8 % 3 — % 6 -16.7 %
Soliqua/iGlarLixi 58 -1.6 % -4.9 % 20 -28.6 % 13 +44.4 % 25 +12.5 %
Tzield (*) 18 +80.0 % +80.0 % 17 +70.0 % — — % 1 — %
Mozobil 12 -60.6 % -63.6 % 3 -62.5 % 4 -76.5 % 5 -25.0 %
Others 1,010 -11.1 % -13.5 % 85 -24.1 % 309 -9.6 % 616 -9.9 %
Industrial Sales 124 -25.3 % -25.3 % — -100.0 % 123 -23.1 % 1 -80.0 %
Vaccines
RSV (Beyfortus) (**) 841 +106.6 % +105.1 % 420 +34.6 % 335 +252.6 % 86 — %
Polio/Pertussis/Hib vaccines and boosters 632 +10.8 % +10.1 % 143 -12.9 % 116 +5.5 % 373 +25.6 %
Influenza vaccines 454 -36.8 % -38.7 % 178 -18.8 % 130 -49.2 % 146 -40.2 %
Meningitis, Travel and endemic vaccines 249 -4.2 % -5.3 % 101 -22.9 % 56 +22.2 % 92 +10.3 %
Biopharma 10,564 +10.3 % +9.1 % 5,151 +13.3 % 2,433 +6.0 % 2,980 +8.8 %
Pharma launches (*) 827 +56.5 % +55.7 % 562 +53.8 % 140 +44.3 % 125 +87.1 %
Launches (*), (**) 1,668 +78.3% +77.3% 982 +44.9% 475 +147.4% 211 +212.9%

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Appendix 1: FY 2024 net sales by medicine/vaccine and geography
FY 2024
(€ million)
Total sales
% CER % reported United States % CER Europe % CER Rest of World % CER
Immunology
Dupixent 13,072 +23.1 % +22.0 % 9,544 +17.2 % 1,618 +31.9 % 1,910 +50.8 %
Kevzara 424 +21.0 % +18.8 % 246 +26.2 % 121 +5.2 % 57 +38.3 %
Rare diseases
Fabrazyme 1,047 +9.1 % +5.8 % 531 +5.6 % 254 +5.4 % 262 +19.9 %
ALTUVIIIO (*) 682 +330.2 % +328.9 % 617 +298.1 % — — % 65 +1575.0 %
Nexviazyme/Nexviadyme (*) 667 +61.2 % +56.9 % 361 +32.7 % 201 +101.0 % 105 +132.1 %
Cerezyme 742 +20.3 % +8.2 % 191 +1.1 % 244 +6.6 % 307 +45.5 %
Alprolix 588 +9.6 % +8.9 % 464 +5.5 % — — % 124 +28.0 %
Myozyme 671 -12.3 % -14.2 % 234 -7.5 % 260 -23.8 % 177 +2.1 %
Cerdelga 333 +12.8 % +11.7 % 186 +13.4 % 128 +8.5 % 19 +37.5 %
Eloctate 368 -20.8 % -21.9 % 236 -30.8 % — — % 132 +5.4 %
Cablivi (*) 249 +9.7 % +9.7 % 136 +21.4 % 93 -6.1 % 20 +23.5 %
Aldurazyme 297 +12.2 % +6.5 % 72 +7.5 % 84 +2.4 % 141 +20.8 %
Xenpozyme (*) 151 +68.1 % +65.9 % 81 +55.8 % 46 +48.4 % 24 +225.0 %
Enjaymo (*) 105 +48.6 % +45.8 % 58 +40.5 % 17 +183.3 % 30 +29.2 %
Neurology
Aubagio 379 -59.4 % -60.3 % 187 -59.1 % 152 -65.2 % 40 -17.2 %
Oncology
Sarclisa (*) 471 +29.7 % +23.6 % 200 +21.2 % 134 +20.7 % 137 +52.4 %
Jevtana 290 -7.8 % -9.4 % 214 -7.0 % 7 -41.7 % 69 -5.1 %
Fasturtec 183 +8.2 % +7.6 % 119 +8.2 % 48 +9.3 % 16 +5.9 %
Other main medicines
Lantus 1,628 +20.8 % +14.6 % 638 +127.0 % 340 -4.8 % 650 -5.8 %
Toujeo 1,227 +13.4 % +9.3 % 217 +1.9 % 479 +8.6 % 531 +23.0 %
Lovenox 982 -7.0 % -12.5 % 9 +28.6 % 567 -9.0 % 406 -4.9 %
Plavix 914 -0.4 % -3.6 % 6 -25.0 % 91 -5.2 % 817 +0.4 %
Rezurock (*) 470 +51.6 % +51.6 % 425 +40.6 % 28 +460.0 % 17 +700.0 %
Thymoglobulin 492 +7.3 % +2.9 % 312 +6.5 % 39 +2.7 % 141 +10.1 %
Praluent 483 +15.2 % +14.5 % — -100.0 % 340 +14.9 % 143 +15.0 %
Aprovel 416 +1.0 % -0.2 % 4 -55.6 % 73 -6.4 % 339 +4.2 %
Multaq 311 -9.6 % -9.6 % 278 -10.3 % 11 -8.3 % 22 — %
Soliqua/iGlarLixi 227 +7.8 % +4.6 % 75 -20.0 % 48 +40.0 % 104 +25.3 %
Tzield (*) 54 +116.0 % +116.0 % 52 +108.0 % 1 — % 1 — %
Mozobil 74 -65.9 % -66.4 % 12 -89.9 % 39 -44.3 % 23 -22.6 %
Others 4,262 -7.7 % -11.7 % 364 -16.9 % 1,263 -6.8 % 2,635 -6.8 %
Industrial Sales 523 -5.1 % -5.1 % 1 -75.0 % 520 -1.5 % 2 -89.5 %
Vaccines
RSV (Beyfortus) (**) 1,686 +214.4 % +208.2 % 1,068 +167.3 % 440 +214.3 % 178 — %
Polio/Pertussis/Hib vaccines and boosters 2,741 +1.2 % -0.9 % 679 -5.5 % 497 +4.0 % 1,565 +3.5 %
Influenza vaccines 2,555 -1.3 % -4.3 % 1,433 +4.3 % 640 -7.8 % 482 -7.4 %
Meningitis, Travel and endemic vaccines 1,316 +5.4 % +3.9 % 736 +1.5 % 204 +28.7 % 376 +3.2 %
Biopharma 41,081 +11.3 % +8.6 % 19,986 +16.2 % 9,027 +2.3 % 12,068 +10.7 %
Pharma launches (*) 2,849 71.4 % 68.6 % 1,930 71.6 % 520 47.9 % 399 +108.9 %
Launches (*), (**) 4,535 +106.3 % +102.7 % 2,998 +97.0 % 960 +95.3 % 577 +199.1 %

SANOFI PRESS RELEASE Q4 2024
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Appendix 2: Business net income statement
Q4 2024 Biopharma Other Total group
(€ million) Q4 2024
Q4 2023 (1)
Change Q4 2024
Q4 2023 (1)
Change Q4 2024
Q4 2023 (1)
Change
Net sales 10,564 9,687 9.1 % — — — % 10,564 9,687 9.1 %
Other revenues 774 1,309 -40.9 % 82 72 13.9 % 856 1,381 -38.0 %
Cost of sales
(3,524) (3,571) -1.3 % (52) (54) -3.7 % (3,576) (3,625) -1.4 %
As % of net sales (33.4 %) (36.9 %) (33.9 %) (37.4 %)
Gross profit 7,814 7,425 5.2 % 30 18 66.7 % 7,844 7,443 5.4 %
As % of net sales 74.0 % 76.6 % 74.3 % 76.8 %
Research and development expenses (2,257) (1,814) 24.4 % — (1) -100.0 % (2,257) (1,815) 24.4 %
As % of net sales (21.4 %) (18.7 %) (21.4 %) (18.7 %)
Selling and general expenses (2,647) (2,465) 7.4 % (1) (1) — % (2,648) (2,466) 7.4 %
As % of net sales (25.1 %) (25.4 %) (25.1 %) (25.5 %)
Other operating income/expenses (897) (842) 11 (2) (886) (844)
Share of profit/loss of associates* and joint ventures 32 41 — — 32 41
Net income attributable to non-controlling interests (7) (3) — — (7) (3)
Business operating income 2,038 2,342 -13.0 % 40 14 185.7 % 2,078 2,356 -11.8 %
As % of net sales 19.3 % 24.2 % 19.7 % 24.3 %
Financial income and expenses (62) (45)
Income tax expenses (374) (376)
Tax rate** (18.8 %) (16.5 %)
Business net income 1,642 1,935 -15.1 %
As % of net sales 15.5 % 20.0 %
Business earnings/share (in euros)*** 1.31 1.54 -14.9 %

* Net of tax.
** Determined based on business income before tax, associates, and non-controlling interests.
*** Based on an average number of shares outstanding of 1,253.6 million in Q4 2024 and 1,253.6 million in Q4 2023.
(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.

SANOFI PRESS RELEASE Q4 2024
16

FY 2024 Biopharma Other Total group
(€ million) FY 2024
FY 2023 (1)
Change FY 2024
FY 2023 (1)
Change FY 2024
FY 2023 (1)
Change
Net sales 41,081 37,817 8.6 % — — — % 41,081 37,817 8.6 %
Other revenues 2,866 3,505 -18.2 % 339 296 14.5 % 3,205 3,801 -15.7 %
Cost of sales
(12,973) (12,415) 4.5 % (222) (204) 8.8 % (13,195) (12,619) 4.6 %
As % of net sales (31.6 %) (32.8 %) (32.1 %) (33.4 %)
Gross profit 30,974 28,907 7.2 % 117 92 27.2 % 31,091 28,999 7.2 %
As % of net sales 75.4 % 76.4 % 75.7 % 76.7 %
Research and development expenses (7,393) (6,505) 13.7 % (1) (2) -50.0 % (7,394) (6,507) 13.6 %
As % of net sales (18.0 %) (17.2 %) (18.0 %) (17.2 %)
Selling and general expenses (9,113) (8,854) 2.9 % (70) (79) -11.4 % (9,183) (8,933) 2.8 %
As % of net sales (22.2 %) (23.4 %) (22.4 %) (23.6 %)
Other operating income/expenses (3,305) (2,476) 12 12 (3,293) (2,464)
Share of profit/loss of associates* and joint ventures 136 101 — — 136 101
Net income attributable to non-controlling interests (14) (18) — — (14) (18)
Business operating income 11,285 11,155 1.2 % 58 23 152.2 % 11,343 11,178 1.5 %
As % of net sales 27.5 % 29.5 % 27.6 % 29.6 %
Financial income and expenses (263) (168)
Income tax expenses (2,168) (1,934)
Tax rate** (19.8 %) (17.7 %)
Business net income 8,912 9,076 -1.8 %
As % of net sales 21.7 % 24.0 %
Business earnings/share (in euros)*** 7.12 7.25 -1.8 %

* Net of tax.
** Determined based on Business income before tax, associates, and non-controlling interests.
*** Based on an average number of shares outstanding of 1,251.4 million in FY 2024 and 1,251.7 million in FY 2023.
(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
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Appendix 3: Consolidated income statement
(€ million) Q4 2024
Q4 2023 (1)
FY 2024
FY 2023 (1)
Net sales 10,564 9,687 41,081 37,817
Other revenues 856 1,381 3,205 3,801
Cost of sales (3,576) (3,629) (13,205) (12,628)
Gross profit 7,844 7,439 31,081 28,990
Research and development expenses (2,257) (1,815) (7,394) (6,507)
Selling and general expenses (2,648) (2,466) (9,183) (8,933)
Other operating income 363 204 1,089 979
Other operating expenses (1,249) (1,048) (4,382) (3,443)
Amortization of intangible assets (450) (496) (1,749) (1,911)
Impairment of intangible assets (200) (877) (9) (896)
Fair value remeasurement of contingent consideration (22) (64) (96) (93)
Restructuring costs and similar items (191) (506) (1,396) (1,030)
Other gains and losses, and litigation (5) 13 (470) (196)
Operating income 1,185 384 7,491 6,960
Financial expenses (235) (616) (1,073) (1,293)
Financial income 111 157 519 584
Income before tax and associates and joint ventures 1,061 (75) 6,937 6,251
Income tax expense (190) 90 (1,259) (1,017)
Share of profit/(loss) of associates and joint ventures 9 (134) 60 (136)
Net income from continuing operations 880 (119) 5,738 5,098
Net income from discontinued operations
(185) (439) 64 338
Net income 695 (558) 5,802 5,436
Net income attributable to non-controlling interests 12 (3) 58 36
Net income attributable to equity holders of Sanofi 683 (555) 5,744 5,400
Average number of shares outstanding (million) 1,253.6 1,253.6 1,251.4 1,251.7
Basic earnings per share from continuing operations (in euros)
0.69 (0.09) 4.54 4.04
Basic earnings per share from discontinued operations (in euros)
(0.15) (0.35) 0.05 0.27
Basic earnings per share (in euros)
0.54 (0.44) 4.59 4.31

(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
SANOFI PRESS RELEASE Q4 2024
18

Appendix 4: Reconciliation of net income attributable to equity holders of Sanofi to business net income
(€ million) Q4 2024
Q4 2023 (1)
FY 2024
FY 2023 (1)
Net income attributable to equity holders of Sanofi 683 (555) 5,744 5,400
Net income from discontinued operations 185 439 (64) (338)
Amortization of intangible assets(2)
450 496 1,749 1,911
Impairment of intangible assets 200 877 9 896
Fair value remeasurement of contingent consideration 24 54 127 93
Expenses arising from the impact of acquisitions on inventories — 3 10 9
Restructuring costs and similar items 191 506 1,396 1,030
Other gains and losses, and litigation 5 (13) 470 196
Financial (income) / expense related to liabilities carried at amortized cost other than net indebtedness 62 414 291 541
Tax effect of the items listed above: (82) (470) (828) (940)
Amortization and impairment of intangible assets (149) (225) (304) (473)
Fair value remeasurement of contingent consideration (6) (5) (25) (13)
Restructuring costs and similar items 56 (148) (320) (299)
Other items 17 (92) (179) (155)
Other tax effects (102) 6 (81) 23
Other items 26 178 89 255
Business net income 1,642 1,935 8,912 9,076
IFRS earnings per share(3) (€)
0.54 (0.44) 4.59 4.31

(1) Figures for comparative periods (2023) have been re-presented on a consistent basis to reflect the classification of Opella as a discontinued operation.
(2) Of which related to amortization expense generated by the intangible assets measured at their acquisition-date fair values: -€407 million in Q4 2024 and -€480 million in Q4 2023.
(3) Q4: based on an average number of shares outstanding of 1,253.6 million in Q4 2024 and 1,253.6 million in Q4 2023.
FY: based on an average number of shares outstanding of 1,251.4 million in FY 2024 and 1,251.7 million in FY 2023.

SANOFI PRESS RELEASE Q4 2024
19

Appendix 5: Change in net debt
(€ million) FY 2024
FY 2023 (3)
Business net income 8,912 9,076
Depreciation, amortization and impairment of property, plant and equipment and software 1,546 1,509
Other items (626) (555)
Operating cash flow 9,832 10,030
Changes in working capital (507) 207
Acquisitions of property, plant and equipment and software (1,808) (1,677)
Free cash flow before restructuring, acquisitions, and disposals 7,517 8,560
Acquisitions of intangibles assets, investments, and other long-term financial assets(1)
(1,434) (1,091)
Restructuring costs and similar items paid (933) (849)
Proceeds from disposals of property, plant, and equipment, intangible assets, and other non-current assets net of taxes(1)
805 789
Free cash flow 5,955 7,409
Acquisitions(2)
(2,509) (3,149)
Proceeds net of taxes (2)
609 —
Issuance of Sanofi shares 187 195
Acquisition of treasury shares (302) (593)
Dividends paid to shareholders of Sanofi (4,704) (4,454)
Other items (439) (464)
Net cash provided by/(used in) the discontinued Opella business 322 (300)
Change in net debt before Opella reclassification to "Assets held-for-sale" (881) (1,356)
Impact on net debt of the reclassification of Opella to "Assets held-for-sale" (98) —
Change in net debt (979) (1,356)
Beginning of period 7,793 6,437
Closing of net debt 8,772 7,793

Quest Diagnostics Reports Fourth Quarter and Full Year 2024 Financial Results; Provides Guidance for Full Year 2025; Increases Quarterly Dividend 6.7% to $0.80 Per Share

On January 30, 2025 Quest Diagnostics Incorporated (NYSE: DGX), a leading provider of diagnostic information services, reported financial results for the fourth quarter and full year ended December 31, 2024 (Press release, Quest Diagnostics, JAN 30, 2025, View Source [SID1234649962]).

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"In the fourth quarter, we delivered impressive revenue growth of nearly 15%, including approximately 5% organic growth, while also improving our profitability," said Jim Davis, Chairman, CEO, and President. "For the full year, we drove revenue growth of close to 7%, including approximately 3% from organic growth. Our team completed eight acquisitions, including LifeLabs in Canada, expanded our advanced diagnostics portfolio, and extended our geographic and market reach with new clinical, consumer and health plan customers."

Mr. Davis continued: "Our guidance for 2025 reflects our confidence in the core strength of our business, continuing robust utilization, and the momentum from acquisitions completed in 2024. These dynamics position us favorably to accelerate revenue and earnings growth in 2025."

Select 2024 full year accomplishments:

Completed eight acquisitions, including LifeLabs in Canada and four hospital outreach lab acquisitions.
Extended our health plan access to over 90% of in-network lives nationwide, including in new geographies through collaborations with Elevance Health and Sentara Health Plans, which took effect January 1, 2025.
Grew our Advanced Diagnostics portfolio, adding the sensitive p-tau217 and p-tau181 biomarkers to our AD-Detect blood-based test menu for assessing Alzheimer’s disease risk, and launching the first H5 avian influenza test from a commercial laboratory based on a pandemic preparedness contract from the U.S. Centers for Disease Control and Prevention.
Engaged approximately 75 academic, health system and community oncology centers in our Haystack MRD Early Experience Program, which provided oncologists with advanced access to our Haystack MRD blood test for aiding in the early detection of minimal residual disease from solid tumor cancers. We are now transitioning these organizations to a commercial program and are focused on expanding utilization among oncologists.
Expanded our questhealth.com consumer-initiated test platform to include approximately 135 tests, including micronutrient deficiencies and high-risk Lipoprotein(a) cholesterol testing.
Deployed automation and AI technologies across diverse laboratory, customer service and administrative areas, including automating core laboratory processes at three major regional laboratories, improving quality, customer experiences and productivity.

Three Months Ended December 31,

Twelve Months Ended December 31,

2024

2023

Change

2024

2023

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,621

$ 2,288

14.5 %

$ 9,872

$ 9,252

6.7 %

Diagnostic information services revenues

$ 2,556

$ 2,221

15.1 %

$ 9,614

$ 8,976

7.1 %

Revenue per requisition

0.2 %

1.3 %

Requisition volume

13.9 %

5.5 %

Organic requisition volume

0.6 %

0.7 %

Operating income (a)

$ 361

$ 267

35.3 %

$ 1,346

$ 1,262

6.7 %

Operating income as a percentage of net revenues (a)

13.8 %

11.7 %

2.1 %

13.6 %

13.6 %

— %

Net income attributable to Quest Diagnostics (a)

$ 222

$ 192

15.1 %

$ 871

$ 854

2.0 %

Diluted EPS (a)

$ 1.95

$ 1.70

14.7 %

$ 7.69

$ 7.49

2.7 %

Cash provided by operations

$ 464

$ 527

(12.3) %

$ 1,334

$ 1,272

4.8 %

Capital expenditures

$ 123

$ 72

73.9 %

$ 425

$ 408

4.4 %

Adjusted (a):

Operating income

$ 409

$ 338

21.2 %

$ 1,541

$ 1,457

5.8 %

Operating income as a percentage of net revenues

15.6 %

14.8 %

0.8 %

15.6 %

15.8 %

(0.2) %

Net income attributable to Quest Diagnostics

$ 253

$ 245

3.7 %

$ 1,011

$ 994

1.8 %

Diluted EPS

$ 2.23

$ 2.15

3.7 %

$ 8.93

$ 8.71

2.5 %

(a)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Dividend Increased

Quest Diagnostics’ Board of Directors has authorized a 6.7% increase in its quarterly dividend from $0.75 to $0.80 per share, or $3.20 per share annually, effective with the dividend payable on April 21, 2025 to shareholders of record of Quest Diagnostics common stock on April 7, 2025. The company has raised its dividend annually since 2011.

Guidance for Full Year 2025

The company estimates its full year 2025 guidance in the table below. The company has included a presentation that includes additional guidance information on the Events and Presentations page of its investor relations website, which can be found at www.QuestDiagnostics.com/investor.

Low

High

Net revenues

$10.70 billion

$10.85 billion

Net revenues increase

8.4 %

9.9 %

Reported diluted EPS

$8.34

$8.59

Adjusted diluted EPS

$9.55

$9.80

Cash provided by operations

Approximately $1.45 billion

Capital expenditures

Approximately $500 million

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, gains and losses associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on January 30, 2025 until midnight Eastern Time on February 13, 2025, by phone at 866-360-8701 for domestic callers and 203-369-0179 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.