BioMarin Reports Third Quarter 2025 Results and Provides Corporate Update

On October 27, 2025 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported financial results for the third quarter ended September 30, 2025.

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"We are pleased with the contributions from our Enzyme Therapies and Skeletal Conditions business units to date this year driven by more than 20% revenue growth from PALYNZIQ and VOXZOGO," said Alexander Hardy, President and Chief Executive Officer of BioMarin. Our strategic investments in these focused business units are generating strong results, and we anticipate sustained financial performance from each of them. Both Enzyme Therapies and Skeletal Conditions remain central to our growth strategy, in addition to new business development opportunities and our advancing internal pipeline. As we focus on the business units aligned with our strategic priorities, today we are announcing the decision to pursue options to divest ROCTAVIAN and remove it from our portfolio. We continue to believe ROCTAVIAN has an important role to play in the treatment of hemophilia A and are therefore evaluating out-licensing options for this innovative gene therapy. This decision is consistent with BioMarin’s portfolio strategy and offers the most promising opportunity for ensuring continued patient access to ROCTAVIAN.

Mr. Hardy concluded, "Looking ahead, we will rely on our disciplined strategic focus and proven capabilities to develop and commercialize innovative therapies that generate sustainable value for patients, employees, and shareholders."

Third Quarter 2025 Financial Highlights
•Total Revenues for the third quarter of 2025 were $776 million, an increase of 4% compared to the same period in 2024, driven by strong revenue growth in VOXZOGO and PALYNZIQ attributable to new patients initiating therapy across all regions. These increases were partially offset by lower sales volume for ALDURAZYME due to timing of order fulfillment to Sanofi and NAGLAZYME due to timing of large government orders in Latin America.

•GAAP Net Loss increased to $31 million for the third quarter of 2025 compared to GAAP Net Income of $106 million for the same period in 2024. The increase in GAAP Net Loss was primarily due to the In-Process Research & Development (IPR&D) charge of $221 million recorded in connection with the acquisition of Inozyme Pharma, Inc. (Inozyme). This increase in GAAP Net Loss was partially offset by improved gross profit as a result of revenue growth mentioned above, lower Cost of Sales from favorable product mix during the quarter, and lower provision for income taxes.

•Non-GAAP Income for the third quarter of 2025 decreased to $22 million compared to $178 million for the same period in 2024. The decrease in Non-GAAP Income was primarily due to the factors noted above.
Third Quarter 2025 Business Highlights
Innovation
•Skeletal Conditions: At the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, investigators shared new data demonstrating improved spinal morphology – one of the factors that contributes to spinal stenosis, a leading cause of morbidity in achondroplasia – following treatment with VOXZOGO in children ages 5 and under (see PR here). VOXZOGO is the only approved therapy with data showing a positive impact on spinal morphology, and these findings add to the extensive body of evidence supporting VOXZOGO’s health benefits beyond improving growth.

•As a follow-up to the encouraging PK data announced last quarter for BMN 333, BioMarin’s long-acting C-type natriuretic peptide, the company plans to initiate dosing of children with achondroplasia in its registration-enabling Phase 2/3 study in the first half of 2026.

•VOXZOGO pivotal data for the treatment of hypochondroplasia is expected in the first half of 2026, followed by potential launch in 2027, should data be supportive. Hypochondroplasia can be associated with significant co-morbidities, including respiratory, orthopedic, mental health, and ear nose and throat complications, representing high unmet medical need for this skeletal condition with no approved therapies.

•Four new VOXZOGO indications are under development as part of BioMarin’s CANOPY clinical program, with a focus on the most severely impacted sub-set of children. These conditions include idiopathic short stature, Noonan syndrome, Turner syndrome, and SHOX deficiency, and are currently enrolling patients, with potential registration-enabling studies in 2027.

•Enzyme Therapies: Based on new data from the PALYNZIQ Phase 3 PEGASUS study in 12- to 17-year-olds demonstrating statistically significant blood phenylalanine (Phe) lowering compared to diet alone, the company is pursuing approvals in this age group in the United States and Europe, with potential approval in 2026.

•With BMN 401, a potential first-in-disease treatment for ENPP1 deficiency, initial pivotal data readout for the ENERGY 3 study in children ages 1–12 years is anticipated in the first half of 2026, with potential launch in 2027.

•Other Clinical Updates: For BMN 351, BioMarin’s next generation oligonucleotide for Duchenne muscular dystrophy, the company expects to share a clinical update for the 6 mg/kg and 9 mg/kg cohorts by year-end.

Growth

•As of the end of the quarter, children with achondroplasia in 55 countries around the world were being treated with VOXZOGO, tracking to the company’s plan to open access in more than 60 countries by 2027. Year-to-date VOXZOGO revenue increased 24% Y/Y, with Q4’25 VOXZOGO revenue expected to reach its highest level of the year. BioMarin reaffirmed full-year 2025 VOXZOGO revenue outlook of between $900 million and $935 million.

•Representing approximately 75% of total VOXZOGO revenue, markets outside of the U.S. (OUS) benefited from BioMarin’s established global footprint to drive VOXZOGO uptake across key large markets during the quarter.

•Initiatives implemented to expand treatment with VOXZOGO in the U.S. resulted in new patient starts across all ages in the third quarter, with the majority from children under 2 years of age. Due to the geographical dispersion and management across a range of specialties for older children in the U.S, the company has implemented initiatives to address slowing uptake in that demographic.

•PALYNZIQ marked its third consecutive quarter of 20%+ Y/Y growth. PALYNZIQ strength continued to be driven by greater numbers of patients titrating to daily maintenance dose and strong adherence. Total Enzyme Therapies revenue grew 8% Y/Y, year-to-date, reflecting high penetration rates and strong adherence to these treatments.

•Today, the company announced its plan to pursue options to divest ROCTAVIAN, including exploring out-licensing opportunities. BioMarin plans to continue to make ROCTAVIAN commercially available in the U.S., Italy and Germany until next steps are finalized. The company will continue to provide support and monitoring for people treated with ROCTAVIAN.

Value Commitment

•Acquired IPR&D charges in Q3 from BioMarin’s acquisition of Inozyme resulted in Y/Y increases in GAAP and Non-GAAP R&D expenses. Q3 GAAP and Non-GAAP SG&A expenses increased Y/Y due to investment in business unit expansion initiatives. Year-to-date GAAP Diluted EPS and Non-GAAP Diluted EPS increased Y/Y, driven by underlying strong revenue performance and operational efficiencies.

•The company generated operating cash flows totaling $369 million in third quarter 2025 and generated $728 million in year-to-date operating cash flows. Total cash and investments at the end of the third quarter were approximately $2.0 billion, and increasing operating cash flow is expected to continue, supporting BioMarin’s priority of investment in innovation and future growth.

•Today, BioMarin increased total revenue guidance, at the midpoint, reflecting strong demand for its therapies through 2025. Revised Non-GAAP Operating Margin and Non-GAAP Diluted EPS guidance include the impact of Q3 acquired IPR&D expenses, partially offset by underlying strong topline performance and operational execution throughout the year.

Refer to the 2025 Full-Year Financial Guidance on page 4 of this press release.
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended
September 30, Nine Months Ended
September 30,
2025 2024 % Change 2025 2024 % Change
Total Revenues $776 $746 4% $2,347 $2,107 11%
Net Product Revenues by Product:
VOXZOGO $218 $190 15% $654 $527 24%
Enzyme Therapies:
VIMIZIM $183 $178 3% $587 $549 7%
NAGLAZYME 122 132 (8)% 365 370 (1)%
PALYNZIQ 109 91 20% 308 255 21%
ALDURAZYME 54 71 (24)% 159 145 10%
BRINEURA 48 37 30% 137 121 13%
Total Enzyme Therapies Revenue $516 $509 1% $1,556 $1,440 8%
KUVAN $24 $28 (14)% $76 $93 (18)%
ROCTAVIAN
$3 $7 (57)% $23 $16 44%
GAAP Net Income (Loss)(1)
$(31) $106 (129)% $395 $302 31%
Non-GAAP Income (1)(2)
$22 $178 (88)% $525 $506 4%
GAAP Operating Margin % (1)(3)
(6.0)% 15.3% 19.4% 15.3%
Non-GAAP Operating Margin % (1)(2)
2.8% 27.7% 26.3% 27.7%
GAAP Diluted Earnings (Loss) per Share (EPS)(1)
$(0.16) $0.55 (129)% $2.04 $1.56 31%
Non-GAAP Diluted EPS (1)(2)
$0.12 $0.91 (87)% $2.69 $2.60 3%

September 30,
2025 December 31,
2024
Total cash, cash equivalents & investments $ 1,991 $ 1,659

(Press release, BioMarin, OCT 27, 2025, View Source [SID1234657031])

Amphista Therapeutics’ successful degradation of a key cancer target, BRD9, via a novel mechanism with DCAF16 E3 ligase published in Nature Communications

On October 27, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in next generation targeted protein degradation (TPD), reported that it has published data in the journal Nature Communications demonstrating, for the first time, a new mechanism of action for BRD9 degradation using the Company’s novel Targeted Glue small molecule degrader.

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Amphista’s proprietary Targeted Glues are prospectively and rationally designed medicines. "The deep expertise of our scientists led to the successful integration of the favorable performance characteristics of earlier generation PROTACs and conventional molecular glues but with key limitations designed-out." commented Louise Modis, PhD, Chief Scientific Officer at Amphista Therapeutics.

As a result, Amphista’s proprietary Targeted Glues specifically target a protein of interest with a ligand, like PROTACs, and like glues they stabilize interactions with a ligase. However, the resulting chemical modifications to the ligands generated with Amphista’s medicinal chemistry attract specific non-cereblon (CRBN) and non-VHL-based ligases that recognize the neo protein interface and tag it for degradation.

The Nature Communications paper describes the design of a newly defined AMPTX-1 Targeted Glue and its ability to selectively and potently target BRD9 for degradation by inducing the formation of a ternary complex with DCAF16, a relatively uncharacterised E3 ligase that has not previously been successfully utilised for TPD in vivo. The key interaction between the Targeted Glue for BRD9 and DCAF16 has been mapped to a reversible covalent interaction with cysteine 58.

"What’s really neat," Louise explains, "is that our Targeted Glues don’t have any inherent affinity for the ligases on their own. This only occurs once the Targeted Glue has bound first to the protein of interest. For this reason, we describe our molecules as being ‘sequentially bifunctional’ to differentiate them from how traditional bifunctional molecules work, establishing a new approach for targeted protein degradation."

The Targeted Glue facilitated chemical modification to the targeted ligand is also smaller and more drug-like than conventional PROTAC binders and therefore offers the advantages of smaller molecules for drug development, similar to molecular glues.

"It is the first time that BRD9, a key protein involved in cancer, has been shown to be degraded using a non-CRBN or VHL mechanism," commented Giles Brown, PhD Senior Vice President of Chemistry at Amphista Therapeutics. "Using our unique approach and deep scientific knowledge, we’re showing how Amphista leads the way in creating a much-needed new generation of degraders."

Amphista’s Targeted Glue therapeutics expand the range of E3 ligases that can be recruited therapeutically to specific targets to overcome the limitations of earlier generation CRBN and VHL-based PROTACs.

Louise Modis continued, "This novel discovery published in Nature Communications validates a new approach to targeted protein degradation and we look forward to carrying this positive momentum through our maturing pipeline of assets."

"We are rapidly unlocking the full potential of Targeted Glues by expanding our TPD toolbox of utilized E3 ligases to build new medicines that transform the lives of patients with severe diseases," added Giles Brown.

The full paper can be accessed here.

The publication follows announcements by Amphista unveiling novel differentiated mechanisms of action for the degradation of BRD9 and TEAD, and first details of its SMARCA2 program.

(Press release, Amphista Therapeutics, OCT 27, 2025, View Source [SID1234657030])

Guardant Health to Share Data Supporting Critical Role of Blood-Based Testing in Improving Cancer Screening Adherence at ACG 2025

On October 26, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data showing the critical role of blood-based testing in increasing cancer screening adherence at the American College of Gastroenterology (ACG) 2025 Annual Meeting in Phoenix, Arizona taking place Friday, October 24 – Wednesday, October 29, 2025.

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Building off findings from Guardant Health’s 2023 ACG abstract, a study of an expanded cohort of 20,000 patients confirmed findings from earlier reports on the effectiveness of the Shield blood-based screening test in improving adherence to colorectal cancer (CRC) screening. Shield is the first and only blood test to receive FDA approval as a primary screening option for colorectal cancer in average-risk adults aged 45 and older. The findings demonstrated an over 90% adherence rate for Shield, tracking well above average screening adherence for overall CRC testing which ranges from 28-71%. 1-4

A separate study led by researchers at Cedars Sinai found that individuals prefer a blood test for colorectal cancer and lung cancer over other methods, showing the potential for an innovative blood test like Shield to increase the overall screening rate in lung cancer screening. The survey found that more screening-eligible individuals (43.9%) prefer to do a blood test for colorectal cancer and lung cancer compared to traditional screenings.

"Today’s research reinforces what Guardant has long believed: blood-based cancer screening is the future," said Dr. Craig Eagle, Chief Medical Officer at Guardant Health. "These studies highlight the power of a simple blood test in addressing today’s gaps in colorectal cancer screening adherence and potential to expand to an even broader population looking for a more pleasant option for their regular lung cancer screening. We’re eager to present these findings along with our research collaborators at the ACG meeting and proud to offer Shield, an FDA-approved test, as an accessible and convenient alternative to traditional screening methods."

Guardant Health and collaborator presentations at ACG 2025

Presentation

Title

Time / Location

Sunday, October 26

P0302

Implementation of Blood-Based Colorectal Cancer Screening Demonstrates High Adherence: Real-World Clinical Experience

3:30-7:00pm PDT / Exhibit Hall

P1515

Detection of Hepatocellular Carcinoma via Blood-Based Testing in High-Risk Individuals

3:00-3:30pm PDT / Exhibit Hall

Tuesday, October 28

P4744

Assessing Patient Preferences for Blood-Based Lung Cancer and Colorectal Cancer Screening Tests: Insights from a Conjoint Analysis with over 1,700 People in the US

10:30am-4:00pm ET / Exhibit Hall

The full abstracts for Guardant Health and a list of all abstracts being presented at the ACG Annual Meeting can be found here.

About Shield

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

(Press release, Guardant Health, OCT 26, 2025, View Source [SID1234657023])

WuXi AppTec Achieves Strong Double-Digit Growth in Revenue and Profit for Q1-Q3 2025 Backlog for Continuing Operations Up 41.2% YoY Further Raises 2025 Full-year Guidance

On October 26, 2025 WuXi AppTec (stock code: 603259.SH / 2359.HK), a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the pharmaceutical and life sciences industry, reported financial results for the first three quarters ending September 30, 2025 ("Reporting Period"):

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For the first three quarters of 2025, total revenue reached RMB32.86 billion, up 18.6% year-over-year. Revenue from Continuing Operations reached RMB32.45 billion, up 22.5% year-over-year.
Adjusted non-IFRS gross profit reached RMB15.46 billion, with the adjusted non-IFRS gross profit margin up 6.1pts year-over-year to 47.0%.
Net profit attributable to the owners of the Company was RMB12.08 billion, up 84.8% year-over-year; diluted EPS was RMB4.21, up 87.9% year-over-year.
Adjusted non-IFRS net profit attributable to the owners of the Company was RMB10.54 billion, up 43.4% year-over-year; adjusted non-IFRS net profit margin up 5.6pts year-over-year to 32.1%; adjusted non-IFRS diluted EPS was RMB3.68, up 46.0% year-over-year.
With continuous capacity expansion to better meet customer demand, backlog for Continuing Operations reached RMB59.88 billion as of September 30, 2025, up 41.2% year-over-year.
Operating cash flow climbed 35.0% year-over-year to RMB10.87 billion, driven by business growth, increase in operating efficiency, and continued improvement of financial management capabilities.
Sustained and steady business growth as a result of our unique, fully integrated Contract Research, Development and Manufacturing Organization (CRDMO) platform. Driven by "follow the molecule" and "win the molecule" strategies, WuXi Chemistry’s small molecule CRDMO pipeline continues to efficiently convert and capture high-quality molecules, delivering sustained business growth. In the first three quarters of 2025, a total of 621 new molecules were added to the small molecule Development and Manufacturing (D&M) pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, representing an increase of 15 projects in phase III and commercial stages during the first three quarters of 2025.
Acceleration of global expansion, capacity construction and capability development. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. By the end of 2025, total reactor volume of small molecule APIs is expected to reach over 4,000kL. In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
Robust shareholder returns. The Company remains committed to rewarding shareholders and actively supporting the Company’s value. This year, the Company has implemented a total of RMB6.88 billion in cash dividends, share repurchases and cancellations, representing more than 70% of the Company’s 2024 net profit attributable to the owners of the Company. Among these, the Company has distributed a total of RMB4.88 billion in cash dividends, including RMB2.83 billion for the 2024 annual cash dividend, RMB1.01 billion for the 2025 special cash dividend and RMB1.03 billion for the 2025 interim dividend. Meanwhile, the Company also completed the repurchase of RMB2.0 billion worth of A-shares in total, all of which have been cancelled.
[1] As disclosed in 2025 Third Quarterly Report, Continuing Operations include WuXi Chemistry, WuXi Testing, WuXi Biology and Others, the scope of which may change following adjustments to the Company’s business strategy.

[2] Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS).

[3] In 2024 Q1-Q3 and 2025 Q1-Q3, WuXi AppTec had a fully-diluted weighted average share count of 2,906,724,914 and 2,873,641,499 ordinary shares, respectively.

2025 Full-Year Outlook

With confidence in customers’ ongoing demand for enabling services, our CRDMO business model and management execution, the Company has further raised its full-year guidance.

The Company expects Continuing Operations revenue to resume double-digit growth in 2025, with its year-over-year growth rate raised to 17-18%, up from the prior 13-17%. As a result, the Company expects full-year total revenue of RMB43.5-44.0 billion, up from the prior RMB42.5-43.5 billion.

As it focuses on the core CRDMO business and continuously improved production and operating efficiency, the Company is confident and expects to further improve the adjusted non-IFRS net profit margin in 2025.

The Company is actively advancing global capacity construction; while due to longer-than-expected settlement cycles of certain projects, capex for 2025 is expected to reach RMB5.5-6.0 billion (adjusted from the prior RMB7.0-8.0 billion). Together with business growth, efficiency improvement, and considering the timing differences in project payments, free cash flow for 2025 is expected to increase from RMB5.0-6.0 billion to RMB8.0-8.5 billion.

Management Comment

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Reflecting robust customer demand and the strength of our unique CRDMO business model, WuXi AppTec delivered strong double-digit growth in revenue, profit and operating cash flow in the first three quarters of 2025, while our backlog for Continuing Operations reached a record RMB59.9 billion. Based on this momentum, we have further raised our full-year revenue and free cash flow guidance. The strategic divestment of clinical research services enables us to fully focus on our core CRDMO strategy and better meet the evolving needs of our customers. By concentrating on drug discovery, laboratory testing, process development, and manufacturing services, we are accelerating the growth of our global capabilities and capacities, delivering greater value for customers and shareholders, and advancing our vision that ‘every drug can be made and every disease can be treated’."

Business Performance by Segment

WuXi Chemistry: CRDMO Business Model Drives Continuous Growth; Q1-Q3 2025 Revenue Up 29.3 % YoY , with TIDES Revenue Up 121.1% YoY
Q1-Q3 revenue of WuXi Chemistry reached RMB25.98 billion, up 29.3% year-over-year. With continued optimization of production process and improvement in capacity efficiency driven by the growth of late-stage clinical and commercial projects, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Chemistry steadily improved 5.8pts year-over-year to 51.3%.
Small molecule drug discovery service ("R") continues to generate downstream opportunities. In the past 12 months, we successfully synthesized and delivered more than 430,000 new compounds to customers. In the meantime, 250 molecules were converted from R to D phase in the first three quarters of 2025. Through our "follow-the-customer" and "follow-the-molecule" strategies, we established trusted partnerships with our customers globally, supporting the sustainable growth of our CRDMO business.
Small molecule D&M service remains strong.
The small molecule CDMO pipeline continued to expand. Q1-Q3 revenue of small molecule D&M services rose 14.1% year-over-year to RMB14.24 billion. In the first three quarters of 2025, 621 new molecules were added to the small molecule D&M pipeline. As of September 30, 2025, our small molecule D&M pipeline reached 3,430 molecules, including 80 commercial projects, 87 in phase III, 374 in phase II and 2,889 in phase I and pre-clinical stages. This represents an increase of 15 projects in the commercial and phase III stages during the first three quarters of 2025.
We continued to build small molecule capacity. In March 2025, both the Changzhou and Taixing API manufacturing sites successfully passed FDA on-site inspections with no single observation. The total reactor volume of small molecule APIs is expected to reach over 4,000kL by the end of 2025.
TIDES business (oligo and peptides) sustains rapid growth.
With the ramp-up of new capacities released sequentially each quarter last year, Q1-Q3 TIDES revenue grew 121.1% year-over-year to RMB7.84 billion. As of September 30, 2025, TIDES backlog grew 17.1% year-over-year.
TIDES D&M customers grew 12% year-over-year, while the number of TIDES molecules grew 34% year-over-year.
In September 2025, the construction of peptide capacity in Taixing was completed ahead of schedule; the Company’s total reactor volume of Solid Phase Peptide Synthesizers has been increased to more than 100,000L.
WuXi Testing: Drug Safety Evaluation Service & Site Management Organization (SMO) Maintain Leading Positions
WuXi Testing revenue reached RMB4.17 billion in Q1-Q3, and Q1-Q3 adjusted non-IFRS gross profit margin was 26.5%.
With development of differentiated capabilities and enhanced operational management, Q3 revenue of lab testing services reached RMB1.08 billion, growing 7.2% year-over-year and 7.5% quarter-over-quarter; while its Q3 adjusted non-IFRS gross profit margin continued to improve quarter-over-quarter. Of which, the revenue of drug safety evaluation services grew 5.9% year-over-year and 13.2% quarter-over-quarter.
Q1-Q3 revenue of lab testing services grew 2.7% year-over-year to RMB2.96 billion. Due to market impact, its Q1-Q3 adjusted non-IFRS gross profit margin declined as pricing was gradually reflected in revenue along with backlog conversion. Of which, drug safety evaluation services revenue resumed positive year-over-year growth, while maintaining an industry-leading position in the Asia-Pacific region.
The Company is committed to actively enabling customers’ global licensing. New modality business continued to develop, while the Company maintained its leading position in areas including nucleic acids, conjugates, mRNA, multispecific antibodies and peptides.
The Company continued to advance automation. DMPK successfully launched its proprietary all-in-one compound identification software, enhancing efficiency in spectral interpretation and metabolite identification for nucleic acids and peptides by 83%.
The Suzhou facility has successfully passed 4 consecutive FDA on-site inspections.
Q1-Q3 revenue for clinical CRO & SMO was down 6.4% year-over-year to RMB1.21 billion due to market pricing impact; of which, SMO revenue was down 0.7% year-over-year as backlog gradually converted into revenue, while maintaining its industry leading position in China.
During the first three quarters of 2025, our clinical CRO business supported customers in obtaining 19 IND approvals and submitting for 2 NDA filings; the SMO business supported 75 new drug approvals for customers. The SMO business has supported 331 new drug approvals in total over the past decade, maintaining significant advantages in multiple areas (endocrinology, dermatology, lung cancer and cardiovascular disease, etc.).
WuXi Biology: Continues to Generate Downstream Opportunities; In Vitro & In Vivo Business Synergies and New Modality Business Drive Growth
WuXi Biology follows the science, continuously strengthens drug discovery capabilities in emerging areas and actively grows overseas businesses. It efficiently generates downstream opportunities for CRDMO model by continuously contributing more than 20% of the Company’s new customers.
Through cross-regional collaboration, comprehensive platform integration and integrated project transformation, we efficiently enable our customers worldwide. WuXi Biology revenue reached RMB1.95 billion in Q1-Q3 2025, a year-over-year increase of 6.6%.
Due to market pricing impact, Q1-Q3 adjusted non-IFRS gross profit margin of WuXi Biology was down 1.0pts to 37.0%. With continuously improved operational efficiency, its Q3 adjusted non-IFRS gross profit margin improved 1.5pts quarter-over-quarter.
We accelerated advancements in in vitro integrated screening technologies and continued to improve in vivo pharmacology capabilities, resulting in rapid year-over-year and quarter-over-quarter revenue growth. With its competitive edge continuously strengthened, the non-oncology business has achieved strong revenue growth, becoming an important contributor to business growth.
New modality drug discovery services continue to perform well, contributing more than 30% of WuXi Biology’s total revenue.
This release provides a summary of the results and does not intend to provide a complete statement relating to the Company, its securities, or any relevant matters herein that a recipient may need in order to evaluate the Company. For additional information, please refer to the WuXi AppTec 2025 Third Quarterly Results Presentation and 2025 Third Quarterly Report disclosed on the Company’s official website, as well as the Company’s disclosure documents and information on the Shanghai Stock Exchange, the Stock Exchange of Hong Kong Limited website. Investors are advised to exercise caution and be aware of the investment risks in trading Company shares.

Net profit attributable to the owners of the Company is prepared in accordance with China Accounting Standards for Business Enterprises (CAS), in currency of RMB. Besides, all other financial information disclosed in this press release is prepared in accordance with the International Financial Reporting Standards Accounting Standards ("IFRSs"), in currency of RMB.

The 2025 Third Quarterly Report of the Company has not been audited.

Third Quarter 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross Profit
Margin

WuXi Chemistry

9,676.68

22.7 %

5,329.83

40.6 %

55.1 %

WuXi Testing

1,480.83

2.1 %

428.69

-10.0 %

28.9 %

WuXi Biology

695.67

5.9 %

264.49

1.8 %

38.0 %

Others

191.78

163.8 %

161.60

658.4 %

84.3 %

Discontinued Operations (Note 1)

12.47

-96.9 %

12.47

N/A

100.0 %

Total

12,057.43

15.3 %

6,197.08

38.4 %

51.4 %

First Three Quarters 2025 Results by Segments

Unit: RMB million

Segment

Revenue

Change

Adjusted non-
IFRS Gross
Profit

Change

Adjusted
non-IFRS
Gross
Profit
Margin

WuXi Chemistry

25,978.06

29.3 %

13,314.69

45.7 %

51.3 %

WuXi Testing

4,169.47

0.0 %

1,104.58

-26.1 %

26.5 %

WuXi Biology

1,947.27

6.6 %

720.38

3.8 %

37.0 %

Others

355.26

-10.5 %

258.90

24.1 %

72.9 %

Discontinued Operations (Note 1)

406.65

-66.5 %

56.49

N/A

13.9 %

Total

32,856.72

18.6 %

15,455.04

36.3 %

47.0 %

Note 1: In accordance with the IFRSs, the Company has classified the operations for which equity sale agreements were signed or sales were completed during the first three quarters of 2025 or the comparison year as discontinued operations.

Note 2: Any sum of the data above that is inconsistent with the total is due to rounding.

Consolidated Statement of Profit or Loss [4] – Prepared under IFRSs

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Revenue

12,057.4

10,461.1

32,856.7

27,702.0

Cost of sales

(6,050.8)

(6,063.8)

(17,737.9)

(16,603.8)

Gross profit

6,006.6

4,397.3

15,118.9

11,098.2

Other income

280.4

247.6

920.0

758.6

Other gains and losses

188.0

(602.5)

2,637.0

(394.1)

Impairment losses under expected credit losses

("ECL") model, net of reversal

(169.0)

(72.5)

(459.6)

(154.6)

Impairment losses of non-financial assets

(80.0)

(153.5)

Impairment losses of assets classified as held for sale

(120.7)

Selling and marketing expenses

(175.0)

(189.1)

(569.4)

(546.6)

Administrative expenses

(721.8)

(687.4)

(1,969.5)

(1,964.9)

R&D expenses

(311.2)

(317.7)

(825.7)

(954.0)

Operating Profit

5,018.1

2,775.7

14,577.4

7,842.5

Share of results of associates

199.9

87.1

440.1

202.9

Share of results of joint ventures

0.6

0.2

0.6

(4.0)

Finance costs

(88.8)

(58.2)

(257.6)

(187.2)

Profit before tax

5,129.7

2,804.7

14,760.5

7,854.3

Income tax expense

(1,583.8)

(484.0)

(2,830.9)

(1,252.7)

Profit for the period

3,545.8

2,320.8

11,929.6

6,601.6

Profit for the period attributable to:

Owners of the Company

3,514.6

2,293.1

11,801.9

6,532.9

Non-controlling interests

31.2

27.7

127.6

68.7

3,545.8

2,320.8

11,929.6

6,601.6

[4] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Profit or Loss[5] (continued) – Prepared under IFRSs

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Weighted average number of ordinary shares for calculating EPS

(expressed in shares)

– Basic

2,839,378,755

2,883,580,115

2,839,864,290

2,899,626,297

– Diluted

2,877,629,997

2,889,573,492

2,873,641,499

2,906,724,914

Earnings per share (expressed in RMB per S hare)

– Basic

1.24

0.80

4.16

2.25

– Diluted

1.22

0.79

4.12

2.24

[5] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position[6] – Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Non-current Assets

Property, plant and equipment

25,662.5

25,267.8

Right-of-use assets

1,837.0

1,874.8

Goodwill

866.0

972.4

Other intangible assets

420.1

601.0

Interests in associates

1,939.2

2,322.2

Interests in joint ventures

3.9

3.4

Deferred tax assets

512.9

473.1

Financial assets at fair value through profit or
loss ("FVTPL")

8,350.8

8,943.4

Other non-current assets

115.7

114.7

Biological assets

1,085.7

1,063.0

Total Non-current Assets

40,793.8

41,635.7

Current Assets

Inventories

6,011.0

3,532.1

Contract costs

929.0

912.2

Biological assets

903.7

955.5

Amounts due from related parties

115.5

89.3

Trade and other receivables

10,731.6

9,643.7

Contract assets

819.0

988.8

Income tax recoverable

42.8

87.2

Financial assets at FVTPL

3,561.0

1,234.0

Derivative financial instruments

1.8

Other current assets

742.3

734.1

Pledged bank deposits

57.5

22.1

Term deposits with initial term of over three
months

3,921.4

4,865.6

Bank balances and cash

25,459.9

13,434.3

53,296.6

36,498.8

Assets classified as held for sale

515.7

2,191.3

Total Current Assets

53,812.3

38,690.2

Total Assets

94,606.1

80,325.8

[6] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Consolidated Statement of Financial Position (continued)[7]– Prepared under IFRSs

RMB Million

September 3 0 ,

December 31,

2025

2024

Current Liabilities

Trade and other payables

7,746.5

7,025.5

Amounts due to related parties

7.9

15.3

Derivative financial instruments

2.9

202.0

Contract liabilities

2,565.7

2,251.0

Bank borrowings

5,282.1

1,278.6

Lease liabilities

179.9

224.2

Income tax payables

2,249.9

870.8

Convertible bonds

1,294.5

3,493.1

19,329.3

15,360.6

Liabilities directly associated with assets
classified as held for sale

109.0

865.5

Total Current Liabilities

19,438.3

16,226.1

Non-current Liabilities

Bank borrowings

1,799.1

2,959.5

Deferred tax liabilities

433.7

522.4

Deferred income

929.9

985.6

Lease liabilities

532.7

546.6

Total Non-current Liabilities

3,695.4

5,014.1

Total Liabilities

23,133.6

21,240.2

Net Assets

71,472.5

59,085.6

Capital and Reserves

Share capital

2,965.7

2,888.0

Reserves

67,982.4

55,744.7

Equity attributable to owners of the Company

70,948.1

58,632.7

Non-controlling interests

524.4

452.9

Total Equity

71,472.5

59,085.6

[7] If the sum of the data below is inconsistent with the total, it is caused by rounding.

Adjusted Non-IFRS Net Profit Attributable to the Owners of the Company[8]

RMB Million

Three Months Ended September 30,

Nine Months Ended September 30,

2025

2024

2025

2024

Net p rofit attributable to the owners of the Company under CAS

3,514.6

2,293.1

12,075.5

6,532.9

GAAP difference[9]

(273.6)

Net p rofit attributable to the owners of the Company under IFRSs

3,514.6

2,293.1

11,801.9

6,532.9

Add:

Share-based compensation expenses

249.9

79.4

426.3

244.4

Issuance expenses of convertible bonds

8.7

28.4

Foreign exchange related losses

100.0

629.8

548.0

658.7

Amortization of acquired intangible assets from merger and
acquisition

6.7

13.3

20.5

40.3

Gains or losses from divestiture, restructuring and resource
integration initiatives

88.4

228.3

Non-IFRS net profit attributable to the owners of the Company

3,968.5

3,015.6

13,053.5

7,476.3

Add:

Realized and unrealized losses(gains) from venture capital
investments

254.4

(41.9)

(2,515.7)

(134.6)

Realized and unrealized share of (gains)losses from joint ventures

(0.6)

(0.2)

(0.6)

4.0

Adjusted non-IFRS net profit attributable to the owners of the
Company

4,222.3

2,973.5

10,537.1

7,345.7

(Press release, WuXi AppTec, OCT 26, 2025, View Source [SID1234657022])

Novartis agrees to acquire Avidity Biosciences, an innovator in RNA therapeutics, strengthening its late-stage neuroscience pipeline

On October 26, 2025 Novartis reported that it has entered into an agreement to acquire Avidity Biosciences, Inc. (Nasdaq: RNA), a San Diego-based, biopharmaceutical company focused on a new class of therapeutics enabling RNA delivery to muscle. The acquisition will follow the separation of Avidity’s early-stage precision cardiology programs.

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Avidity is committed to delivering a new class of pioneering RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs) for serious, genetic neuromuscular diseases. The proposed acquisition will bring Avidity’s late-stage neuroscience programs into Novartis and provide Novartis access to a differentiated RNA-targeting delivery platform. These programs are expected to advance the company’s neuroscience strategy and complement the current pipeline with potential first-in-class therapeutic candidates that address the genetic drivers of muscle-damaging conditions.

"Avidity’s pioneering AOC platform for RNA therapeutics ​and its late-stage assets bolster our commitment to delivering innovative, targeted and potentially first-in-class medicines to treat devastating, progressive neuromuscular diseases," said Vas Narasimhan, CEO of Novartis. "The Avidity team has built robust programs with industry-leading delivery of RNA therapeutics to muscle tissue. We look forward to developing these programs to meaningfully change the trajectory of diseases for patients."

The proposed acquisition raises the expected 2024-2029 sales CAGR for Novartis from +5% to +6% CAGR, representing a significant opportunity to deliver substantial shareholder returns over time.

Accelerating innovative RNA science and AOC therapies for patients with neuromuscular disease
The proposed acquisition aligns with the long-term neuroscience strategy of Novartis, expanding the company’s pipeline with potential near-term launches in genetically defined diseases with high unmet need. The Avidity programs feature potential first-in-class, late-stage disease-modifying therapies in myotonic dystrophy type 1 (DM1), a rare progressive neuromuscular disorder with a poor prognosis and no disease-modifying therapies; facioscapulohumeral muscular dystrophy (FSHD), a rare hereditary disorder causing relentless loss of muscle function and progressive disability; and Duchenne muscular dystrophy (DMD), a severe, early-onset disease marked by progressive muscle damage and reduced life expectancy.

The proposed acquisition is expected to create an industry-leading pipeline, building on the Novartis expertise in spinal muscular atrophy and commercialization capabilities in genetic neuromuscular diseases. Avidity aims to deliver meaningful patient benefits by addressing root genetic causes, restoring muscle function, and potentially slowing disease progression. Its AOC platform combines the tissue specificity of monoclonal antibodies with the precision of oligonucleotides, enabling targeted delivery to previously hard-to-reach muscle cells. AOCs carry disease-specific, oligonucleotide payloads intended to correct underlying genetic mechanisms and enable targeted, disease-modifying therapies with the potential to have significant impact on patient lives.

Transaction details
Under the terms of the transactions, which have been unanimously approved by the Boards of Directors of both companies, Novartis, through a merger with a newly formed indirect wholly owned subsidiary, will acquire all outstanding shares of Avidity. Pursuant to the terms of the merger agreement, holders of Avidity common stock will receive USD 72.00 per share in cash at closing, representing a premium of 46% to the closing share price on October 24, 2025, and valuing the company at approximately USD 12bn on a fully diluted basis and representing an enterprise value of approximately USD 11bn at the expected closing date.

Prior to the closing of the merger, Avidity will transfer to SpinCo, a wholly owned subsidiary of Avidity, the early-stage precision cardiology programs and collaborations of Avidity. The transfer includes certain Avidity assets whose transfer will trigger a right of first negotiation with an existing collaboration partner of Avidity. Holders of Avidity common stock will receive (1) a distribution of one share of SpinCo for every ten shares of Avidity they hold and/or (2) a pro rata cash distribution of the proceeds received by Avidity prior to the closing if certain SpinCo assets are, or SpinCo itself is, sold to a third party.

The acquisition by Novartis of Avidity is subject to the completion of a spin-off or a sale of SpinCo and other customary closing conditions, including the receipt of regulatory approvals and the approval of Avidity stockholders. The companies expect the merger to close in the first half of 2026. Until closing, Novartis and Avidity will continue to operate as separate and independent companies.

Novartis Investor Call
Novartis will host a conference call for investors to discuss the transaction on October 27, 2025 at 1 pm CET. Details can be found at View Source

(Press release, Novartis, OCT 26, 2025, View Source [SID1234657019])