On November 5, 2025 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the quarter ended September 30, 2025.

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Mr. Richard Francis, Teva’s President and CEO, said, "Our innovative portfolio driving the 11th consecutive quarter of growth in the third quarter reflects the accelerating momentum of our transformation and the strength of our innovation-led Pivot to Growth strategy. Our key growth drivers—particularly our innovative medicines—delivered a 33% increase in local currency, underscoring their impact on both patient outcomes and our financial performance. As we continue executing our strategy, we remain firmly on track to reach our 30% non-GAAP operating profit margin by 2027 and ~$700 million of net savings target."

Mr. Francis added, "Following the conclusion of the IRA pricing negotiations, we are reiterating our strong confidence in our AUSTEDO 2027 target. Our differentiated innovative portfolio is now a defining strength for Teva as we transform into a leading innovative biopharma, while our world-class generics business continues to provide a resilient foundation. With our talented team and unwavering commitment to patients, we are confident about Teva’s future and our ability to deliver enduring value to all our stakeholders."

Pivot to Growth Strategy

In the third quarter of 2025, we continued to execute on the four key pillars of our "Pivot to Growth" strategy, announced in May 2023. As part of this strategy, in the second quarter of 2025 Teva entered its "Accelerate Growth" phase, during which we expect to focus on growing our innovative portfolio, aligning capital allocation to invest in activities we expect to have the highest value, and modernizing our organization and operations to drive both efficiency and cost savings.

Delivering on our Growth Engines – on the first pillar, our key innovative brands – AUSTEDO, AJOVY and UZEDY – continued to demonstrate strong performance. Collectively, these products grew ~33% in Q3 2025 YoY in local currency. For AUSTEDO, we are raising the 2025 revenue outlook by $50 million – $100 million to a new range of $2,050 million – $2,150 million. For AJOVY and UZEDY, we are reaffirming our previous outlooks of $630 million – $640 million and $190 million – $200 million, respectively. The conclusion of the IRA pricing negotiations reinforces confidence in our long-term outlook for AUSTEDO. We are on track for our 2027 revenue target of >$2.5 billion for AUSTEDO and peak year revenue target of >$3 billion. During the third quarter of 2025, the FDA approved an expansion of AJOVY’s indication, to include its use as an anti-CGRP preventive treatment for pediatric episodic migraine in patients aged 6 to17 years who weigh 45 kg or more. This approval marks an important step in Teva’s efforts to advance care for neurological conditions.
Stepping Up Innovation – on the second pillar, we continued to accelerate the development of certain key pipeline assets. For olanzapine LAI, we presented new long-term safety data from the SOLARIS Trial with no PDSS observed and anticipate filing its New Drug Application (NDA) in Q4 2025. Teva’s investigational therapy emrusolmin (TEV-56286) received U.S. FDA Fast Track designation for the treatment of Multiple System Atrophy (MSA), a rare and progressive neurodegenerative disease with no approved treatments to slow its progression —another step forward in Teva’s commitment to advancing innovative neuroscience therapies. Phase 3 programs for duvakitug (anti-TL1A) in UC and CD were initiated by Sanofi and Teva in October 2025; on track to achieve target enrollment levels in the adult and pediatric populations for DARI’s (Dual-action Asthma Rescue Inhaler) Phase 3 trial at the end of 2025.
Sustaining Our Generics Powerhouse – on the third pillar, we remain focused on strengthening our world-class global generics business with a streamlined portfolio of high-value complex generics and biosimilars, a robust pipeline, and an integrated global manufacturing and commercial footprint. In the U.S., we received FDA approval and launched liraglutide injection (the generic version of Saxenda), the first-ever generic GLP-1 treatment indicated for weight loss. This milestone strengthens Teva’s complex generics portfolio, expanding access to effective weight management options for adults and adolescents. Our recently launched biosimilars – SIMLANDI (adalimumab-ryvk), SELARSDITM (ustekinumab-aekn) and EPYSQLI (eculizumab-aagh) – continue to grow as does our legacy biosimilar portfolio.
Focusing our Business – Lastly, on the fourth pillar, to accelerate our growth, we are actively transforming and modernizing our business through Teva Transformation programs. On May 7, 2025, we announced that these programs are expected to generate ~$700 million of net savings through 2027. We are on track to achieving our targeted savings for 2025.
Teva continues in its effort to sell its active-pharmaceutical ingredient (API) business. Exclusive discussions with a selected buyer on the sale have terminated. Teva is initiating a renewed sales process, maintaining its strategic intention to divest its API business. On December 31, 2024, Teva classified the business (including its R&D, manufacturing and commercial activities) as held for sale.

Third Quarter 2025 Consolidated Results

Revenues in the third quarter of 2025 were $4,480 million, an increase of 3% in U.S. dollars, or 1% in local currency terms compared to the third quarter of 2024. This increase was mainly due to higher revenues from AUSTEDO and from generic products including biosimilars in our U.S. segment, partially offset by lower revenues from generic products in our International Markets segment due to the divestment of our business venture in Japan, from generic products in our Europe segment, and from certain other innovative products in all of our segments, as well as lower year-over-year proceeds from the sale of certain product rights.

Exchange rate movements during the third quarter of 2025, net of hedging effects, positively impacted revenues by $106 million, compared to the third quarter of 2024.

Exchange rate movements during the third quarter of 2025, including hedging effects, had a positive impact of $21 million on our operating income and non-GAAP operating income compared to the third quarter of 2024.

Gross profit in the third quarter of 2025 was $2,304 million, an increase of 7% compared to $2,148 million in the third quarter of 2024. Gross profit margin was 51.4% in the third quarter of 2025, compared to 49.6% in the third quarter of 2024. Non-GAAP gross profit was $2,475 million in the third quarter of 2025, an increase of 6% compared to $2,327 million in the third quarter of 2024. Non-GAAP gross profit margin was 55.3% in the third quarter of 2025, compared to 53.7% in the third quarter of 2024. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to higher revenues from AUSTEDO.

Research and Development (R&D) expenses, net in the third quarter of 2025 were $256 million, an increase of 7% compared to $240 million in the third quarter of 2024. Our higher R&D expenses, net in the third quarter of 2025 compared to the third quarter of 2024, were mainly due to an increase in immunology projects, partially offset by a decrease in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), which was also impacted by a reimbursement from our strategic partnerships in the third quarter of 2024.

Selling and Marketing (S&M) expenses in the third quarter of 2025 were $656 million, an increase of 5% compared to the third quarter of 2024. This increase was mainly to support revenue growth in our key innovative products and in generic products.

General and Administrative (G&A) expenses in the third quarter of 2025 were $317 million, an increase of 6% compared to the third quarter of 2024. This increase was mainly due to costs related to optimization activities of Teva’s global organization and operations in connection with Teva’s Transformation programs, as well as a negative impact from exchange rate fluctuations.

Other loss in the third quarter of 2025 was $7 million, compared to other income of $21 million in the third quarter of 2024. Other income in the third quarter of 2024 included a capital gain from the sale of a business in our International Markets segment.

Operating income in the third quarter of 2025 was $882 million, compared to an operating loss of $51 million in the third quarter of 2024. Operating income as a percentage of revenues was 19.7% in the third quarter of 2025, compared to an operating loss as a percentage of revenues of 1.2% in the third quarter of 2024. This increase was mainly due to the goodwill impairment charge and higher legal settlements and loss contingencies recorded in the third quarter of 2024. Non-GAAP operating income in the third quarter of 2025 was $1,294 million representing a non-GAAP operating margin of 28.9% compared to $1,214 million representing 28.0%, respectively, in the third quarter of 2024. The increase in non-GAAP operating margin in the third quarter of 2025 was due to higher gross profit margin, partially offset by an increase in operating expenses as a percentage of revenues.

Financial expenses, net in the third quarter of 2025 were $237 million, mainly comprised of net-interest expenses of $209 million. In the third quarter of 2024, financial expenses, net were $272 million, mainly comprised of net-interest expenses of $225 million and a negative exchange rate impact, driven mainly from currencies which we were unable to hedge.

In the third quarter of 2025, we recognized a tax expense of $214 million, on a pre-tax income of $646 million. In the third quarter of 2024, we recognized a tax expense of $69 million, on a pre-tax loss of $324 million.

Non-GAAP tax rate in the third quarter of 2025 was 14.7%, compared to 16.0% in the third quarter of 2024. Our non-GAAP tax rate in the third quarter of 2025 was mainly affected by changes in deferred tax balances due to statutory tax rate changes and interest and inflation adjustments related to the agreement with the Israeli Tax Authorities. Our non-GAAP tax rate in the third quarter of 2024 was mainly affected by the generation of profits in various jurisdictions with different tax rates, an adjustment to Teva’s corporate tax rate in Israel on losses related to non-qualified tax incentive activities in Israel, recording of valuation allowance with respect to certain carry over credits outside of Israel, as well as infrequent or non-recurring items.

We expect our annual non-GAAP tax rate for 2025 to be between 15%-18%, slightly higher than our non-GAAP tax rate for 2024, which was 15.3%, mainly due to a net tax benefit related to deferred tax assets resulting from intellectual property-related integration plans in 2024.

Net income attributable to Teva and diluted earnings per share in the third quarter of 2025 were $433 million and $0.37, respectively, compared to a net loss attributable to Teva and loss per share of $437 million and $0.39, respectively, in the third quarter of 2024. This change was mainly due to higher operating income in the third quarter of 2025, partially offset by higher income taxes, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the third quarter of 2025 were $910 million and $0.78, respectively, compared to $798 million and $0.69, respectively, in the third quarter of 2024.

Adjusted EBITDA was $1,394 million in the third quarter of 2025, an increase of 5%, compared to $1,327 million in the third quarter of 2024.

As of September 30, 2025 and 2024, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,184 million shares and 1,167 million shares, respectively.

Non-GAAP information: non-GAAP adjustments for non-GAAP net income attributable to Teva and non-GAAP diluted EPS in the third quarter of 2025 were $478 million and consisted of the following adjustments:

Amortization of purchased intangible assets of $144 million, of which $134 million is included in cost of sales and the remaining $10 million in S&M expenses;
Impairment of long-lived assets of $79 million;
Legal settlements and loss contingencies of $60 million;
Contingent consideration expenses of $16 million;
Equity compensation expenses of $34 million;
Restructuring expenses of $29 million;
Financial expenses of $7 million;
Other non-GAAP items of $51 million; and
Corresponding tax effects and unusual tax items of $58 million.
We believe that excluding such items facilitates investors’ understanding of our business including underlying trends, thereby improving the comparability of our business performance results between reporting periods.

For a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and for additional information, see the tables below and the information included under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow generated from operating activities during the third quarter of 2025 was $369 million, compared to $693 million in the third quarter of 2024. The lower cash flow generated from operating activities in the third quarter of 2025 was mainly due to timing of sales and collections, as well as higher legal settlement payments, partially offset by lower tax payments and higher profit.

During the third quarter of 2025, we generated free cash flow of $515 million, which we define as comprising $369 million in cash flow generated from operating activities, $274 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $8 million of proceeds from divestitures of businesses and other assets, partially offset by $136 million in cash used for capital investment. During the third quarter of 2024, we generated free cash flow of $922 million, which we define as comprising $693 million in cash flow generated from operating activities, $339 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $38 million in divestitures of businesses and other assets, partially offset by $148 million in cash used for capital investment. The decrease in the third quarter of 2025 mainly resulted from lower cash flow generated from operating activities, as well as a decrease in proceeds from divestitures of businesses and other assets.

As of September 30, 2025, our debt was $16,790 million, compared to $17,783 million as of December 31, 2024. This decrease was mainly due to repayment at maturity of $1,812 million of our senior notes, partially offset by an increase of $791 million due to exchange rate fluctuations. Additionally, during the second quarter of 2025, we repurchased $2,290 million aggregate principal amount of notes upon consummation of a cash tender offer, and issued $2,298 million of senior notes, net of discount and issuance costs. The portion of total debt classified as short-term as of September 30, 2025 was negligible compared to 10% as of December 31, 2024. Our average debt maturity was approximately 5.85 years as of September 30, 2025, compared to 5.5 years as of December 31, 2024.

Segment Results for the Third Quarter of 2025

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the three months ended September 30, 2025 and 2024:

Three months ended September 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 2,483 100% $ 2,225 100%
Cost of sales 996 40.1% 960 43.1%
Gross profit 1,486 59.9% 1,265 56.9%
R&D expenses 161 6.5% 151 6.8%
S&M expenses 278 11.2% 259 11.6%
G&A expenses 114 4.6% 107 4.8%
Other (3) § § §
Segment profit* $ 937 37.7% $ 748 33.6%
* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our United States segment in the third quarter of 2025 were $2,483 million, an increase of $257 million, or 12%, compared to the third quarter of 2024. This increase was mainly due to higher revenues from our key innovative products, primarily AUSTEDO, and generic products including biosimilars.

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the three months ended September 30, 2025 and 2024:

Three months ended
September 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)

Generic products (including biosimilars) $ 1,175 $ 1,094 7%
AJOVY 73 58 27%
AUSTEDO 601 435 38%
BENDEKA and TREANDA 35 40 (13%)
COPAXONE 62 69 (9%)
UZEDY 43 35 24%
Anda 392 380 3%
Other 101 115 (13%)
Total $ 2,483 $ 2,225 12%

Generic products (including biosimilars) revenues in our United States segment in the third quarter of 2025 were $1,175 million, an increase of 7% compared to the third quarter of 2024. This increase was mainly driven by higher revenues from our portfolio of biosimilar products.

Among the most significant generic products we sold in the United States in the third quarter of 2025 were lenalidomide capsules (the generic version of Revlimid), epinephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr) and Truxima (the biosimilar to Rituxan). In the third quarter of 2025, our total prescriptions were approximately 261 million (based on trailing twelve months), representing 6.7% of total U.S. generic prescriptions, compared to approximately 292 million (based on trailing twelve months), representing 7.6% of total U.S. generic prescriptions in the third quarter of 2024, all according to IQVIA data.

AJOVY revenues in our United States segment in the third quarter of 2025 were $73 million, an increase of 27% compared to the third quarter of 2024, mainly due to growth in volume. In the third quarter of 2025, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 32.0% out of the subcutaneous injectable anti-CGRP class, compared to 29.1% in the third quarter of 2024. In August 2025, the FDA approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6 to 17 years.

AUSTEDO revenues (which include AUSTEDO XR) in our United States segment in the third quarter of 2025 were $601 million, an increase of 38%, compared to $435 million in the third quarter of 2024. This increase was mainly due to growth in volumes.

During the third quarter of 2025, Teva and the Centers for Medicare and Medicaid Services ("CMS") negotiated a maximum fair price for the AUSTEDO products, based on CMS’s list of prescription medicines selected for price-setting discussions, in which they were originally included. The agreement is expected to be announced by CMS in November 2025. The revised prices set by the U.S. Government, will become effective January 1, 2027 and will apply to eligible Medicare patients.

AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023 in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. The FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg in May 2024 and in a 18 mg dose in July 2024. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, in addition to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the third quarter of 2025 were $43 million, an increase of 24% compared to the third quarter of 2024, mainly due to growth in volume.

BENDEKA and TREANDA combined revenues in our United States segment in the third quarter of 2025 were $35 million, a decrease of 13% compared to the third quarter of 2024, mainly due to competition from alternative therapies, as well as from generic bendamustine products.

COPAXONE revenues in our United States segment in the third quarter of 2025 were $62 million, a decrease of 9% compared to the third quarter of 2024, mainly due to competition.

Anda revenues from third-party products in our United States segment in the third quarter of 2025 were $392 million, an increase of 3%, compared to $380 million in the third quarter of 2024. This increase was mainly due to higher volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States.

United States Gross Profit

Gross profit from our United States segment in the third quarter of 2025 was $1,486 million, an increase of 17%, compared to $1,265 million in the third quarter of 2024.

Gross profit margin for our United States segment in the third quarter of 2025 increased to 59.9%, compared to 56.9% in the third quarter of 2024. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from AUSTEDO.

United States Profit

Profit from our United States segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our United States segment in the third quarter of 2025 was $937 million, an increase of 25% compared to $748 million in the third quarter of 2024. This increase was mainly due to higher gross profit, as discussed above.

Europe Segment

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended September 30, 2025 and 2024:

Three months ended September 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 1,235 100% $ 1,265 100%
Cost of sales 570 46.1% 566 44.8%
Gross profit 665 53.9% 698 55.2%
R&D expenses 62 5.0% 55 4.3%
S&M expenses 225 18.2% 203 16.0%
G&A expenses 75 6.1% 67 5.3%
Other § § 1 §
Segment profit* $ 303 24.5% $ 373 29.5%
* Segment profit does not include amortization and certain other items.
§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our Europe segment in the third quarter of 2025 were $1,235 million, a decrease of 2%, or $30 million, compared to the third quarter of 2024. In local currency terms, revenues decreased by 10% compared to the third quarter of 2024, mainly due to higher proceeds from the sale of certain product rights in the third quarter of 2024, and lower revenues from generic products, partially offset by higher revenues from AJOVY.

In the third quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $91 million, including hedging effects, compared to the third quarter of 2024. Revenues in the third quarter of 2025, included $6 million from a positive hedging impact, which is included in "Other" in the table below. Revenues in the third quarter of 2024 included $10 million from a negative hedging impact, which is included in "Other" in the table below.

Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the three months ended September 30, 2025 and 2024:

Three months ended
September 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 982 $ 973 1%
AJOVY 66 56 18%
COPAXONE 44 53 (18%)
Respiratory products 52 60 (13%)
Other* 91 124 (26%)
Total $ 1,235 $ 1,265 (2%)
*Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our Europe segment in the third quarter of 2025 were $982 million, an increase of 1% compared to the third quarter of 2024. In local currency terms, revenues decreased by 5%, mainly due to lower volumes and price reductions as a result of market dynamics and lower sales of seasonal OTC products, partially offset by higher revenues from recently launched products.

AJOVY revenues in our Europe segment in the third quarter of 2025 increased by 18% to $66 million, compared to $56 million in the third quarter of 2024. In local currency terms revenues increased by 11% due to growth in volume.

COPAXONE revenues in our Europe segment in the third quarter of 2025 were $44 million, a decrease of 18% compared to the third quarter of 2024. In local currency terms revenues decreased by 23%, due to price reductions and lower volumes resulting from the availability of alternative therapies.

Respiratory products revenues in our Europe segment in the third quarter of 2025 were $52 million, a decrease of 13% compared to the third quarter of 2024. In local currency terms, revenues decreased by 18%, mainly due to net price reductions and lower volumes associated with the availability of alternative therapies.

Europe Gross Profit

Gross profit from our Europe segment in the third quarter of 2025 was $665 million, a decrease of 5% compared to $698 million in the third quarter of 2024.

Gross profit margin for our Europe segment in the third quarter of 2025 decreased to 53.9%, compared to 55.2% in the third quarter of 2024. This decrease was mainly due to higher proceeds from the sale of certain product rights in the third quarter of 2024, and an unfavorable mix of products, partially offset by a positive impact from hedging activities.

Europe Profit

Profit from our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the third quarter of 2025 was $303 million, a decrease of 19%, compared to $373 million in the third quarter of 2024. This decrease was mainly due to lower gross profit and higher S&M expenses.

International Markets Segment

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries.

The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, and branded generics-oriented markets, such as Russia and certain Latin America markets.

On March 31, 2025, we divested our Teva-Takeda business venture in Japan, which included generic products and legacy products.

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2025 and 2024:

Three months ended September 30,
2025 2024
(U.S. $ in millions / % of Segment Revenues)
Revenues $ 557 100% $ 613 100%
Cost of sales 280 50.2% 307 50.1%
Gross profit 278 49.8% 306 49.9%
R&D expenses 26 4.6% 27 4.4%
S&M expenses 122 21.9% 134 21.9%
G&A expenses 36 6.4% 36 5.8%
Other § § § §
Segment profit* $ 95 17.0% $ 109 17.8%
* Segment profit does not include amortization and certain other items.

§ Represents an amount less than $0.5 million or 0.5%, as applicable.

Revenues from our International Markets segment in the third quarter of 2025 were $557 million, a decrease of 9%, or 10% in local currency terms compared to the third quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan, partially offset by higher revenues, mainly from generic products in other markets.

In the third quarter of 2025, revenues were positively impacted by exchange rate fluctuations of $9 million, including hedging effects, compared to the third quarter of 2024. Revenues in the third quarter of 2025 included $2 million from a positive hedging impact, compared to a positive hedging impact of $1 million in the third quarter of 2024, which are included in "Other" in the table below

The following table presents revenues for our International Markets segment by major products and activities for the three months ended September 30, 2025 and 2024:

Three months ended
September 30, Percentage
Change
2025 2024 2025-2024
(U.S. $ in millions)
Generic products (including OTC and biosimilars) $ 421 $ 477 (12%)
AJOVY 30 24 23%
AUSTEDO 17 13 32%
COPAXONE 8 13 (40%)
Other* 82 86 (4%)
Total $ 557 $ 613 (9%)
*Other revenues in the third quarter of 2025 and 2024 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $421 million in the third quarter of 2025, a decrease of 12% in U.S. dollars. In local currency terms revenues decreased by 13%, compared to the third quarter of 2024, mainly due to the divestment of our business venture in Japan, partially offset by higher revenues in other markets.

AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the third quarter of 2025 were $30 million, compared to $24 million in the third quarter of 2024. In local currency terms, revenues increased by 21%, mainly due to growth in existing markets in which AJOVY was launched.

AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China with Jiangsu Nhwa Hexin Pharmaceutical Marketing Co., Ltd. In April 2025, AUSTEDO received marketing authorization in South Korea. We continue to pursue additional submissions in various other markets.

AUSTEDO revenues in our International Markets segment in the third quarter of 2025 were $17 million compared to $13 million in the third quarter of 2024. In local currency terms, revenues increased by 31%.

COPAXONE revenues in our International Markets segment in the third quarter of 2025 were $8 million compared to $13 million in the third quarter of 2024.

International Markets Gross Profit

Gross profit from our International Markets segment in the third quarter of 2025 was $278 million, a decrease of 9% compared to $306 million in the third quarter of 2024.

Gross profit margin for our International Markets segment in the third quarter of 2025 decreased to 49.8%, compared to 49.9% in the third quarter of 2024.

International Markets Profit

Profit from our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and other expenses (income) related to this segment. Segment profit does not include amortization and certain other items.

Profit from our International Markets segment in the third quarter of 2025 was $95 million, a decrease of 13%, compared to $109 million in the third quarter of 2024. This decrease was mainly due to the divestment of our business venture in Japan.

Other Activities

We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.

On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale. The intention to divest is in alignment with our Pivot to Growth strategy. As of the date of this Press Release, exclusive discussions with a selected buyer on the sale have terminated. Teva is initiating a renewed sales process, maintaining its strategic intention to divest its API business. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.

Revenues from other activities in the third quarter of 2025 were $205 million, a decrease of 10% in U.S. dollars, or 13% in local currency terms, compared to the third quarter of 2024, mainly due to a decrease in revenues from contract manufacturing services in the third quarter of 2025.

API sales to third parties in the third quarter of 2025 were $125 million, a decrease of 4% in both U.S. dollars and local currency terms, compared to the third quarter of 2024.

Outlook for 2025 Non-GAAP Results

$ billions, except EPS or as noted January 2025 May 2025 July 2025 November 2025
Revenues* $16.8 – $17.4 $16.8 – $17.2 $16.8 – $17.2 $16.8 – $17.0
AUSTEDO ($m)* 1,900-2,050 1,950-2,050 2,000-2,050 2,050-2,150
AJOVY ($m)* ~600 ~600 630-640 630-640
UZEDY ($m)* ~160 ~160 190-200 190-200
COPAXONE ($m)* ~370 ~370 ~370 ~370
Operating Income 4.1 – 4.6 4.3 – 4.6 4.3 – 4.6 4.4 – 4.6
Adjusted EBITDA 4.5 – 5.0 4.7 – 5.0 4.7 – 5.0 4.8 – 5.0
Tax Rate 15%-18% 15%-18% 15%-18% 15%-18%
Finance Expenses ~0.9 ~0.9 ~0.9 ~0.9
Diluted EPS ($) 2.35 – 2.65 2.45 – 2.65 2.50 – 2.65 2.55 – 2.65
Free Cash Flow** 1.6 – 1.9 1.6 – 1.9 1.6 – 1.9 1.6 – 1.9
CAPEX* ~0.5 ~0.5 ~0.5 ~0.5
Foreign Exchange Volatile swings in FX can negatively impact revenue and income
* Revenues and CAPEX presented on a GAAP basis.

** Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, November 5, 2025 at 8:00 a.m. ET to discuss its third quarter 2025 financial results and overall business environment.

A question & answer session will follow.

In order to participate, please register in advance here to obtain a local or toll‐free phone number and your personal pin.

A live webcast of the call will be available on Teva’s website at: www.tevapharm.com

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website.

(Press release, Teva, NOV 5, 2025, View Source [SID1234659477])

On November 5, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported financial results for the quarter ended September 30, 2025 and provided a corporate update.

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"We are continuing our strategic alternatives process with the goal of maximizing value for stockholders," said Stephen Brady, president and chief executive officer of Tempest. "In addition, we look forward to the start of the TPST-1495 Phase 2 in collaboration with the NCI and the Cancer Prevention Clinical Trials Network and remain confident in the potential of amezalpat to transform the treatment of first-line HCC and bring meaningful benefit to patients and their families."

Financial Results

Third Quarter 2025

Tempest ended the quarter with $7.5 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by $4.1 million in net proceeds from the June 2025 registered direct offering, as well as $2.8 million in net proceeds from the company’s at-the-market offering program.
Net loss and net loss per share for the quarter were $3.5 million and $0.79, respectively, compared to $10.6 million and $5.32, respectively, for the same period in 2024.
Research and development expenses for the quarter were $0.6 million, compared to $7.6 million for the same period in 2024. The $7.0 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the quarter were $3.0 million, compared to $3.0 million for the same period in 2024, and were primarily related to consulting and professional services.
Year-to-Date

Cash used in operating activities for the nine months ended September 30, 2025 was $23.2 million.
Net loss and net loss per share for the nine months ended September 30, 2025 were $22.2 million and $5.71, respectively, compared to $28.0 million and $15.48, respectively, for the same period in 2024.
Research and development expenses for the nine months ended September 30, 2025 were $12.1 million, compared to $17.7 million for the same period in 2024. The $5.6 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
General and administrative expenses for the nine months ended September 30, 2025 were $10.4 million, compared to $10.4 million for the same period in 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the nine months ended September 30, 2025, as well as consulting and professional services.

(Press release, Tempest Therapeutics, NOV 5, 2025, View Source [SID1234659476])

On November 5, 2025 Seres Therapeutics, Inc. (Nasdaq: MCRB), (Seres or the Company), a leading live biotherapeutics company, reported third quarter 2025 financial results and provided business updates.

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"Following constructive feedback from the FDA, we are working to finalize our SER-155 Phase 2 study protocol for the prevention of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant (allo-HSCT) for hematological malignancies," said Thomas DesRosier and Marella Thorell, co-Chief Executive Officers of Seres. "As we prepare for the next phase of SER-155 development, we continue our efforts aimed at securing the funding needed to conduct the Phase 2 study. We expect to be ready to rapidly operationalize the study once financing is in place, and we expect to obtain interim efficacy and safety results within 12 months of the study start. If these results are consistent with our prior successful Phase 1b study, and supportive of continued development, we believe this milestone should be a significant value-creating event for the Company and shareholders. Based on our on-going engagement with the medical community and assessment of the commercial landscape, we remain highly enthusiastic about the broad potential for SER-155—in allo-HSCT and other medically vulnerable populations."

Mr. DesRosier and Ms. Thorell continued, "In addition to SER-155 development in allo-HSCT, we are expanding our understanding of the broader SER-155 therapeutic opportunity through an ongoing investigator-sponsored study in immune checkpoint related enterocolitis, initiated by the investigator at Memorial Sloan Kettering Cancer Center, and we look forward to obtaining initial efficacy results in early 2026. Additionally, during the third quarter, we implemented cost-reduction measures, including decreasing our workforce. Considering these actions and our current operating plans, we expect to fund operations through the second quarter of 2026, providing flexibility to advance our strategic priorities."

Recent Highlights

SER-155 and Bloodstream Infection (BSI) Prevention

•
Efforts are ongoing to obtain capital and other resources to support the SER-155 Phase 2 study. The Company is evaluating a range of potential deal structures that could leverage Seres’ live biotherapeutics expertise and success, as demonstrated by bringing VOWST, the first FDA-approved oral microbiome therapeutic, from early development through FDA approval.

•
The Company received constructive feedback from the FDA during the third quarter and is working to finalize the planned Phase 2 study protocol for SER-155 in allo-HSCT, which previously received Breakthrough Therapy designation. The study is expected to enroll approximately 248 participants and incorporate an adaptive design and an interim data analysis when approximately half of the enrolled participants have reached the primary endpoint. The Company expects to obtain the interim clinical results within 12 months following study initiation, which it believes will facilitate timely engagement with the FDA on the design of a Phase 3 study, and inform development in adjacent medically vulnerable patient populations. The Company believes that positive results from the Phase 2 study, if achieved, could create significant value and enable advancement into a single Phase 3 trial to support registration.

•
In the third quarter, CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria, awarded Seres a grant of up to $3.6 million, representing the second grant the Company has received from CARB-X. The funds will support the development of an oral liquid formulation of SER-155, potentially expanding patient access for medically vulnerable populations who cannot be dosed with oral capsules.

•
In October, Seres presented an oral presentation at IDWeek 2025. The presentation included new post-hoc analysis from the completed SER-155 Phase 1b study describing differences between the SER-155 and placebo groups, including the bacterial and fungal organisms causing BSIs, BSI event clinical outcomes, antibacterial prophylaxis use, and patterns of antimicrobial resistance (AMR) among the bacterial BSI organisms. These new data illustrated that BSIs occurred despite antibacterial prophylaxis, and that BSI bacteria exhibited AMR. Resistance to multiple antibacterial agents was observed only in the BSI bacteria from placebo-treated participants, two of whom had fatal outcomes related to their BSIs. These new data further support the potential of SER-155 as an innovative alternative approach to the significant unmet medical need for prevention of BSIs in HSCT patients, especially those BSIs associated with AMR that increase the risk of morbidity and mortality.

Development of Biotherapeutics for the Treatment of Inflammatory and Immune Diseases

•
The Company is collaborating with Memorial Sloan Kettering Cancer Center on an investigator-sponsored trial (IST) which is evaluating SER-155 in participants with immune checkpoint related enterocolitis (irEC). Enrollment is anticipated to be completed by the end of 2025, with clinical readout expected in early 2026. IrEC is among the most frequent and severe immune-related adverse events (irAEs) in recipients of immune checkpoint-inhibitor therapy and can be observed in up to 50% of patients, with rates varying based on cancer drug and treatment regimen. Immune checkpoint inhibitors can cause a wide range of irAEs with links to T cell biology and epithelial barrier inflammation, both of which are biological functions shown in our preclinical and clinical pharmacology data to be positively impacted by SER-155. Supportive data from this IST could provide further support for the expansion of indications that may be well suited for our biotherapeutic approach.

•
Seres continues to explore potential R&D partnerships to advance development of its investigational live biotherapeutics in inflammatory and immune diseases, including ulcerative colitis and Crohn’s disease.

Financial Results

The Company has classified all historical operating results for the VOWST business within discontinued operations in the consolidated statements of operations for the comparative periods presented (three and nine months ended September 30, 2024). There is no activity in the current period related to discontinued operations.

•
Seres reported net income from continuing operations of $8.2 million for the third quarter of 2025, as compared to a net loss from continuing operations of $51.0 million for the same period in 2024. The net income of $8.2 million is comprised primarily of a $22.5 million loss from operations offset by a $27.2 million gain on sale of VOWST resulting primarily from the $25 million installment payment received, as expected, from Nestle during the third quarter. The net loss of $51.0 million in 2024 is primarily comprised of a $29.2 million loss from operations plus a $23.4 million loss on the extinguishment of the Oaktree debt, which was retired at completion of the VOWST sale in September 2024.

•
Research and development (R&D) expenses for the third quarter of 2025 were $12.6 million, compared with $16.5 million for the third quarter of 2024. The decrease in R&D expenses was primarily driven by a decrease in personnel and related costs, a decrease in platform investments, and a reduction in clinical expenses resulting from completion of the SER-155 Phase 1b study.

•
General and administrative (G&A) expenses for the third quarter of 2025 were $9.5 million, compared with $12.7 million for the third quarter of 2024. The decrease in G&A expenses was primarily a result of lower personnel and related expenses, including IT-related expenses.

•
Manufacturing services expenses were $0.7 million for the third quarter of 2025. These costs relate to the provision of manufacturing services under the Transition Services Agreement (TSA) with Nestlé, which began in the fourth quarter of 2024. The reimbursement received from Nestlé related to these expenses is recognized in other income.

Cash Runway

As of September 30, 2025, Seres had $47.6 million in cash and cash equivalents. Based on the Company’s current cash position, VOWST transaction-related obligations, and current operating plans, the Company expects to fund operations through the second quarter of 2026. The Company continues to evaluate further opportunities to extend its cash runway.

Conference Call Information

Seres’ management will host a conference call today, November 5, 2025, at 8:30 a.m. ET. The conference call may be accessed by calling 1-800-715-9871 (international callers dial 1-646-307-1963) and referencing the conference ID number 8471287. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com. A webcast replay will be available on the Seres website shortly after the event and will be archived for at least 21 days.

About SER-155

SER-155 is an investigational, oral, live biotherapeutic designed to decolonize gastrointestinal (GI) pathogens, improve epithelial barrier integrity, and induce immune homeostasis, to prevent bacterial bloodstream infections, including those that can harbor antimicrobial resistance (AMR), as well as other pathogen associated negative clinical outcomes, in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

SER-155 has been evaluated in a Phase 1b placebo-controlled study in patients undergoing allo-HSCT, which demonstrated a significant reduction in both bacterial bloodstream infections (BSIs) (77% relative risk reduction) and systemic antibiotic exposure, as well as lower incidence of febrile neutropenia. SER-155 has received Breakthrough Therapy designation for the reduction of bloodstream infections in adults undergoing allo-HCST and Fast Track designation for reducing the risk of infection and graft-versus-host disease in patients undergoing allo-HCST. The early development of the program was supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria.

(Press release, Seres Therapeutics, NOV 5, 2025, View Source [SID1234659475])

On November 5, 2025 Royalty Pharma plc (Nasdaq: RPRX) reported financial results for the third quarter of 2025 and raised full year 2025 guidance for Portfolio Receipts."We delivered strong third quarter 2025 results, raised our full year guidance and are on track to deliver another year of double-digit top-line growth," said Pablo Legorreta, Royalty Pharma’s founder and Chief Executive Officer. "In addition, we had an especially active past few months for deals, expanding our portfolio with three innovative therapies and increasing our Capital Deployment to $2.0 billion for the year. Furthermore, we hosted our Investor Day in September, where we highlighted the rapid growth in the royalty market, the powerful competitive advantages that underscore our leadership, our sustainable and attractive returns and our goal to be the premier capital allocator in life sciences with consistent, compounding growth.

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"Double-digit growth in Royalty Receipts and Portfolio Receipts

•Royalty Receipts grew 11% to $811 million in the third quarter of 2025, primarily driven by Voranigo, Tremfya and the cystic fibrosis franchise. •Portfolio Receipts increased by 11% to $814 million. Significant Capital Deployment in recent months strengthens portfolio •Acquired a royalty on Amgen’s Imdelltra for up to $950 million; entered into a funding agreement on obexelimab with Zenas BioPharma for up to $300 million; and acquired a royalty on Alnylam’s Amvuttra for $310 million.•Repurchased four million Class A ordinary shares for $152 million in the third quarter, with total share repurchases of $1.2 billion in the first nine months of 2025.Positive clinical and regulatory updates across royalty portfolio•Revolution Medicines’ daraxonrasib: positive initial data in first-line metastatic pancreatic cancer supporting Phase 3 initiation in the fourth quarter of 2025; FDA awarded Commissioner’s National Priority Voucher with goal of accelerating development and review.•Roche’s trontinemab: initiated the Phase 3 program for Alzheimer’s disease. Raising financial guidance for full year 2025 (excludes contribution from future transactions)•Royalty Pharma expects 2025 Portfolio Receipts to be between $3,200 million and $3,250 million (previously $3,050 million to $3,150 million), representing expected growth of 14% to 16% (previously 9% to 12%).Financial & Liquidity Summary
Three Months Ended September 30,
(unaudited)
($ and shares in millions)
2025
2024
Change
Portfolio Receipts
814
735
11%
Net cash provided by operating activities
703
704
(0)%
Adjusted EBITDA (non-GAAP)*
779
679
15%
Portfolio Cash Flow (non-GAAP)*
657
617
6%
Weighted average Class A ordinary shares outstanding – diluted
560
593
(6)%

*See "Liquidity and Capital Resources" section. Adjusted EBITDA and Portfolio Cash Flow are non-GAAP liquidity measures calculated in accordance with the credit agreement.
2

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Portfolio Receipts Highlights
Three Months Ended September 30,
(unaudited)
($ in millions)
2025
2024
Change
Products:
Marketers:
Therapeutic Area:
Cystic fibrosis franchise
Vertex
Rare disease
222
207
7%
Trelegy
GSK
Respiratory
96
91
6%
Tysabri
Biogen
Neuroscience
68
68
(0)%
Evrysdi
Roche
Rare disease
52
48
8%
Xtandi
Pfizer, Astellas
Cancer
50
43
15%
Tremfya
Johnson & Johnson
Immunology
49
34
44%
Imbruvica
AbbVie, Johnson & Johnson
Cancer
41
46
(11)%
Promacta
Novartis
Hematology
38
42
(9)%
Voranigo
Servier
Cancer
33
—
n/a
Cabometyx/Cometriq
Exelixis, Ipsen, Takeda
Cancer
21
19
15%
Spinraza
Biogen
Rare disease
14
14
(4)%
Erleada
Johnson & Johnson
Cancer
12
10
23%
Trodelvy
Gilead
Cancer
12
11
6%
Other products(5)
102
98
3%
Royalty Receipts
811
732
11%
Milestones and other contractual receipts
3
3
0%
Portfolio Receipts
814
735
11%

Amounts shown in the table may not add due to rounding.Royalty Receipts was $811 million in the third quarter of 2025, an increase of 11% compared to $732 million in the third quarter of 2024. The increase was primarily driven by Voranigo, Tremfya and the cystic fibrosis franchise. Portfolio Receipts was $814 million in the third quarter of 2025, an increase of 11% compared to $735 million in the third quarter of 2024, primarily driven by the same Royalty Receipts increases noted above. Liquidity and Capital ResourcesRoyalty Pharma’s liquidity and capital resources are summarized below:As of September 30, 2025, Royalty Pharma had cash and cash equivalents of $939 million and total debt with principal value of $9.2 billion, primarily comprised of $8.8 billion of unsecured notes with a weighted average duration of approximately 13 years and an attractive weighted-average cost of debt of 3.75%. This outstanding total debt includes $2.0 billion of senior unsecured notes (2025 Notes) issued in September 2025 with a weighted average coupon rate of 5.16%. Additionally, Royalty Pharma repaid $1.0 billion of senior unsecured notes upon maturity in August 2025.In January 2025, Royalty Pharma announced a new share repurchase program under which it may repurchase up to $3.0 billion of its Class A ordinary shares. Royalty Pharma repurchased approximately four million Class A ordinary shares for $152 million in the third quarter and 35 million shares for $1.2 billion for the first nine months of 2025. The weighted-average number of diluted Class A ordinary shares outstanding for the third quarter of 2025 was 560 million as compared to 593 million for the third quarter of 2024.

Three Months Ended September 30,
(unaudited)
($ in millions)
2025
2024
Portfolio Receipts
814
735
Payments for operating and professional costs
(34)
(55)
Adjusted EBITDA (non-GAAP)
779
679
Interest paid, net
(123)
(62)
Portfolio Cash Flow (non-GAAP)
657
617

Amounts may not add due to rounding.•Adjusted EBITDA (non-GAAP) was $779 million in the third quarter of 2025. Adjusted EBITDA is calculated as Portfolio Receipts minus payments for operating and professional costs.•Portfolio Cash Flow (non-GAAP) was $657 million in the third quarter of 2025. Portfolio Cash Flow is calculated as Adjusted EBITDA minus interest paid or received, net. This measure reflects the cash generated by Royalty Pharma’s business that can be redeployed into value-enhancing royalty acquisitions, used to repay debt, returned to shareholders through dividends or share purchases, or utilized for other discretionary investments. Refer to Table 4 for Royalty Pharma’s reconciliation of each non-GAAP measure to the most directly comparable GAAP financial measure, net cash provided by operating activities.Capital Deployment reflects cash payments during the period for new and previously announced transactions. Capital Deployment was $1.0 billion in the third quarter of 2025, consisting primarily of upfront payments for the Imdelltra and obexelimab funding agreements (see ‘Royalty Transactions’) and research and development funding for litifilimab. Capital Deployment for the first nine months of 2025 amounted to $1.7 billion.The table below details Capital Deployment by category:Capital Deployment
Three Months Ended September 30,
Nine Months Ended September 30,
(unaudited)
(unaudited)
($ in millions)
2025
2024
2025
2024
Purchases of available for sale debt securities
—
—
(75)
(150)
Acquisitions of financial royalty assets
(962)
(1,195)
(964)
(2,009)
Acquisitions of other financial assets
—
—
—
(18)
Development-stage funding payments
(51)
(1)
(402)
(2)
Milestone payments
—
—
(269)
(50)
Investments in equity method investees
—
—
—
(11)
Contributions from legacy non-controlling interests – R&D
(0)
0
0
1
Capital Deployment
(1,013)
(1,195)
(1,709)
(2,239)

Royalty TransactionsDuring 2025, Royalty Pharma has announced new transactions of up to $3.8 billion. The announced transactions amount reflects the entire amount of capital committed for new transactions year to date, including potential future milestones. Recent transactions include:•In November 2025, Royalty Pharma acquired a royalty interest in Alnylam’s Amvuttra from Blackstone for $310 million. Amvuttra is an approved RNAi therapeutic for the treatment of transthyretin (TTR) amyloidosis with cardiomyopathy and for hereditary TTR amyloidosis with polyneuropathy.•In September 2025, Royalty Pharma acquired a synthetic royalty on obexelimab from Zenas BioPharma for an upfront payment of $75 million and up to $225 million in milestone payments contingent on the achievements of certain clinical and regulatory events. Obexelimab is in Phase 3 development for the treatment of immunoglobulin G4-related disease and in Phase 2 development for relapsing multiple sclerosis and systemic lupus erythematosus.•In August 2025, Royalty Pharma acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for an upfront payment of $885 million. BeOne Medicines has the option to sell to Royalty Pharma additional royalties on Imdelltra for up to $65 million within twelve months from the acquisition date. Imdelltra is approved for the treatment of extensive-stage small cell lung cancer.The information in this section should be read together with Royalty Pharma’s reports and documents filed with the SEC at www.sec.gov and the reader is also encouraged to review all other press releases and information available in the Investors section of Royalty Pharma’s website at www.royaltypharma.com.Key Developments Relating to the Portfolio The key developments related to Royalty Pharma’s royalty interests are discussed below based on disclosures from the marketers of the products.
litifilimab
In October 2025, Biogen announced that both litifilimab Phase 3 studies for systemic lupus erythematosus are fully enrolled with expected data readout for both studies now accelerated to the second half of 2026.
obexelimab
In October 2025, Zenas BioPharma announced positive results from the Phase 2 trial of obexelimab in relapsing multiple sclerosis, which demonstrated a highly statistically significant 95% relative reduction in new gadolinium (Gd)-enhancing T1 lesions over week 8 and week 12 compared with placebo. Zenas anticipates reporting 24-week data in relapsing multiple sclerosis in the first quarter of 2026.
trontinemab
In September 2025, Roche announced that it initiated its Phase 3 program for trontinemab in early symptomatic Alzheimer’s disease. Additionally, Roche announced plans to initiate a Phase 3 study in preclinical Alzheimer’s disease, in people at high risk of cognitive decline.
Airsupra
In September 2025, AstraZeneca announced that the FDA approved a supplemental New Drug Application (sNDA) for Airsupra to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared to albuterol.
daraxonrasib
In September 2025, Revolution Medicines announced positive Phase 1 results from its clinical trials evaluating daraxonrasib as a monotherapy and daraxonrasib in combination with chemotherapy in first-line (1L) metastatic pancreatic ductal adenocarcinoma (PDAC). These data support Revolution Medicines’ plan to initiate a Phase 3 trial for daraxonrasib in 1L metastatic PDAC in the fourth quarter of 2025. In October 2025, the FDA granted a non-transferrable voucher for daraxonrasib under the Commissioner’s National Priority Voucher (CNPV) pilot program, which accelerates review times to 1-2 months.
Skytrofa
In July 2025, Ascendis announced the FDA approved Skytrofa for the once-weekly treatment of adults with growth hormone deficiency.
Cabometyx
In July 2025, Ipsen announced that the European Commission (EC) approved Cabometyx for previously treated advanced neuroendocrine tumors.

deucrictibant
In July 2025, Pharvaris announced that it anticipates topline data for the Phase 3 study (RAPIDe-3) evaluating deucrictibant for the on-demand treatment of hereditary angioedema attacks in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) to the FDA in the first half of 2026.
CF Franchise
In July 2025, Vertex announced that the EC approved Alyftrek for people with cystic fibrosis ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

2025 Financial OutlookRoyalty Pharma has provided guidance for full year 2025, excluding new transactions and borrowings announced after the date of this release, as follows:
Provided November 5, 2025
Previous
Portfolio Receipts
$3,200 million to $3,250 million(Growth of ~+14% to 16% year/year)
$3,050 million to $3,150 million(Growth of ~+9% to 12% year/year)
Payments for operating and professional costs
~9% to 9.5% of Portfolio Receipts
~9% to 9.5% of Portfolio Receipts
Interest paid
$275 million
$275 million

The above Portfolio Receipts guidance represents expected growth of 14% to 16% in 2025. Royalty Pharma’s full year 2025 guidance reflects a negligible estimated foreign exchange impact to Portfolio Receipts, assuming current foreign exchange rates prevail for the rest of 2025.Payments for operating and professional costs in the second half of 2025 are expected to decrease due to extinguishment of the management fee following the completion of the internalization transaction on May 16, 2025. Payments for operating and professional costs in 2025 include one-time payments amounting to approximately $70 million (>2% of 2025 Portfolio Receipts), comprised of transaction costs for the Internalization and other one-time items.Total interest paid is based on the semi-annual interest payment schedule of Royalty Pharma’s existing notes and the quarterly interest payment schedule for the term loan assumed as part of the internalization transaction. In 2025, total interest paid is anticipated to be approximately $275 million, including $7 million in the fourth quarter of 2025. These projections assume no additional debt financing in 2025. In the third quarter of 2025, Royalty Pharma collected interest of $7 million on its cash and cash equivalents, which partially offset interest paid. In 2026, Royalty Pharma anticipates interest paid to be approximately $350 – $360 million(7), including interest payments on the $2.0 billion of senior unsecured notes issued in September 2025.

(Press release, Royalty Pharma , NOV 5, 2025, View Source [SID1234659474])

On November 5, 2025 Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, reported its financial results for the quarter ended September 30, 2025, and provided an update on corporate progress.

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"Our diverse clinical and preclinical RAS(ON) inhibitor programs continue to make encouraging progress and deliver on important milestones," said Mark A. Goldsmith, M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. "Backed by robust operational capabilities and a strong financial position, we feel growing momentum in support of our goal to establish new global standards of care for people living with RAS-addicted cancers, including pancreatic, lung and colorectal cancers."

The company reported significant progress on its near-term strategic priorities:

Execute pivotal trials with daraxonrasib monotherapy in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC)

RASolute 302, a global Phase 3 clinical trial of daraxonrasib in patients with previously treated PDAC, is winding down enrollment globally as the company nears completion of enrollment at all U.S. and international sites. The trial remains on track for an expected data readout in 2026.

For daraxonrasib in pancreatic cancer, the FDA recently granted an Orphan Drug Designation as well as a Commissioner’s National Priority Voucher supporting accelerated review, in addition to the previously awarded Breakthrough Therapy Designation.

RASolve 301, a global Phase 3 trial of daraxonrasib in patients with previously treated NSCLC, is now enrolling patients in Europe and Japan in addition to the U.S.

Advance daraxonrasib into earlier line randomized pivotal trials in patients with PDAC and NSCLC

The company recently disclosed new clinical results supporting initiation of RASolute 303, a global Phase 3 registrational trial of daraxonrasib in first line metastatic PDAC. The company remains on track to initiate the trial this year. The trial will evaluate daraxonrasib as monotherapy and in combination with gemcitabine nab-paclitaxel (GnP), each compared with GnP alone. The company expects to share updated daraxonrasib monotherapy and daraxonrasib plus GnP combination data, each in patients with first line PDAC, including preliminary durability, in the first half of 2026.

The company has initiated RASolute 304, a Phase 3 trial of daraxonrasib as adjuvant treatment for patients with resectable PDAC, and is currently activating trial sites. The trial will evaluate patients who have received surgery and perioperative chemotherapy per standard of care, who will be randomized to either observation or daraxonrasib monotherapy for two years. The primary endpoint is disease-free survival, with secondary endpoints of overall survival and safety.

The company remains on track to initiate a registrational trial in 2026 evaluating daraxonrasib in patients with first line metastatic RAS mutant NSCLC in combination with pembrolizumab and chemotherapy.

Generate sufficient data to inform development priorities for the mutant-selective inhibitors elironrasib and zoldonrasib and prepare to initiate one or more pivotal trials either as monotherapy or in a drug combination

New elironrasib monotherapy data presented recently at the AACR (Free AACR Whitepaper)-NCI-EORTC Symposium on Molecular Targets and Cancer Therapeutics (Triple Meeting) showed encouraging response rate and progression-free survival in patients with RAS G12C NSCLC who had previously been treated with a KRAS G12C(OFF) inhibitor. The company continues to expand enrollment in this and other elironrasib monotherapy and combination trials as it explores options for continued development of this differentiated and promising RAS(ON) G12C-selective inhibitor.

In addition, at the Triple Meeting the company presented encouraging preclinical data supporting the RAS(ON) inhibitor doublet of zoldonrasib, the company’s G12D-selective inhibitor, and daraxonrasib in models of KRAS G12D PDAC, furthering the rationale for this RAS(ON) inhibitor doublet as a therapeutic strategy.

With zoldonrasib’s differentiated profile, the company believes this G12D-selective inhibitor has the potential to contribute as a key component of combination regimens in first line PDAC with current standard of care chemotherapy and/or with daraxonrasib as a RAS(ON) inhibitor doublet. The company expects to initiate a registrational trial for a zoldonrasib combination in patients with first line metastatic PDAC in the first half of 2026 and one or more additional pivotal combination trials in 2026 that incorporate either zoldonrasib or elironrasib.

Zoldonrasib is also being evaluated in a Phase 1 monotherapy expansion cohort in patients with previously treated NSCLC as well as in combination regimens, including zoldonrasib with pembrolizumab or daraxonrasib, in NSCLC.

Progress earlier stage pipeline, including advancing next-generation innovations from the company’s highly productive discovery organization

RMC-5127, a RAS(ON) G12V-selective inhibitor, is on track toward planned initiation of a Phase 1 trial in Q1 2026.

Clinical Collaboration Updates
The company has several discovery and clinical collaborations exploring a range of combinations of a RAS(ON) inhibitor with inhibitors of novel targets, including vopimetostat (TNG462), a PRMT5 inhibitor, under an agreement with Tango Therapeutics, and ivonescimab, a bi-specific PD-1/VEGF inhibitor, under an agreement with Summit Therapeutics.

Other Corporate Updates

In support of the company’s growing late-stage development activities and commercialization plans, the company recently announced the appointment of Alan Sandler, M.D. as chief development officer, Alicia Gardner as senior vice president and general manager for the U.S. region, and Gerwin Winter as senior vice president and general manager of the European region.

Financial Highlights

Third Quarter Results

Cash Position: Cash, cash equivalents and marketable securities were $1.93 billion as of September 30, 2025. This balance includes the receipt of the first royalty monetization tranche of $250 million in June 2025 from the company’s partnership with Royalty Pharma, and there remains an additional $1.75 billion in future committed capital under this arrangement.

R&D Expenses: Research and development expenses were $262.5 million for the quarter ended September 30, 2025, compared to $151.8 million for the quarter ended September 30, 2024. The increase in expenses was primarily due to increases in clinical trial expenses and manufacturing expenses for daraxonrasib, zoldonrasib and elironrasib, and personnel-related expenses and stock-based compensation expense related to additional headcount.

G&A Expenses: General and administrative expenses were $52.8 million for the quarter ended September 30, 2025, compared to $24.0 million for the quarter ended September 30, 2024. The increase was primarily due to increases in personnel-related expenses and stock-based compensation expense associated with additional headcount, an increase in commercial preparation activities, and increased legal expenses.

Net Loss: Net loss was $305.2 million for the quarter ended September 30, 2025, compared to net loss of $156.3 million for the quarter ended September 30, 2024.

Financial Guidance
The company reiterates its full year 2025 GAAP net loss guidance of between $1.03 billion and $1.09 billion, which includes estimated non-cash stock-based compensation expense of between $115 million and $130 million.

Webcast
Revolution Medicines will host a webcast this afternoon, November 5, 2025, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time). To listen to the live webcast, or access the archived webcast, please visit: View Source Following the live webcast, a replay will be available on the company’s website for at least 14 days.

(Press release, Revolution Medicines, NOV 5, 2025, View Source [SID1234659473])