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TEVA PHARMACEUTICAL INDUSTRIES LTD

For the period ended Dec 31, 2024. Filed Feb 5, 2025.

View on SEC.gov

About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Feb 5, 2025

TEVA$42.61+2.0%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-K

Period ended 2023-12-31; filed 2024-02-12.

0001193125-24-031005

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-K

Period ended 2024-12-31; filed 2025-02-05.

0001193125-25-020826

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 265 previous paragraphs and 269 current paragraphs.

128 unchanged; 90 reworded; 50 added; 44 removed; 3 previous and 1 current paragraphs rearranged.

Tables are not compared: 77 previous and 87 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (50)

Current report

We are a global pharmaceutical leader, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery and expanded development of modern medicine.

Current report

In 2024, we continued to execute on the four key pillars of our “Pivot to Growth” strategy, which we announced in May 2023.

Current report

The following table presents revenues, expenses and profit for our United States segment for the past two years:

Current report

Revenues from our United States segment in 2024 were $8,034 million, an increase of $303 million, or 4%, compared to 2023, mainly due to higher revenues from generic products, including from lenalidomide capsules (the generic version of Revlimid®) and our innovative products AUSTEDO and UZEDY, as well as revenues from the sale of certain product rights, partially offset by an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, lower revenues from certain innovative products, primarily BENDEKA and TREANDA and COPAXONE, as well as from Anda, our distribution business.

Current report

The following table presents revenues for our United States segment by major products and activities for the past two years:

Current report

Generic products(including biosimilars) revenues in our United States segment in 2024 increased by 15% to $3,599 million, compared to 2023, mainly due to higher revenues from lenalidomide capsules (the generic version of Revlimid®), the launch of liraglutide injection 1.8mg (an authorized generic of Victoza®) and the launch of SIMLANDI (adalimumab-ryvk) injection (the biosimilar to Humira®), partially offset by increased competition to other generic products.

Current report

On February 24, 2024, Alvotech and Teva announced that the FDA approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira®, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis. On May 21, 2024, Alvotech and Teva announced the availability of SIMLANDI in the U.S.

Current report

On April 16, 2024, Alvotech and Teva announced that the FDA has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older.

Current report

On June 24, 2024, Teva announced the launch of liraglutide injection 1.8mg (an authorized generic of Victoza®) in the United States. Liraglutide injection is indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus and reduce the risk of cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

Current report

In July 2024, Teva launched paclitaxel protein-bound particles for injectable suspension (albumin-bound) (a therapeutically equivalent product to Abraxane®) in the United States for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease, the treatment of locally advanced or metastaticnon-small cell lung cancer, and the treatment of patients with metastatic adenocarcinoma of the pancreas.

Current report

On October 1, 2024, Teva launched octreotide acetate for injectable suspension, the first generic version of Sandostatin® LAR Depot. Octreotide acetate for injectable suspension is indicated for the treatment of acromegaly and severe diarrhea associated with carcinoid syndrome, and is available to patients in the U.S.

Current report

UZEDY revenues in our United States segment in 2024 were $117 million.

Current report

For more information on UZEDY, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—UZEDY.”

Current report

Anda revenues from third parties in our United States segment in 2024 decreased by 3% to $1,536 million, compared to 2023, mainly due to lower volumes. Anda, our distribution business in the United States, distributes generic, biosimilar 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. Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

Current report

R&D expenses relating to our United States segment in 2024 were $633 million, an increase of 5% compared to $604 million in 2023.

Current report

G&A expenses relating to our United States segment in 2024 were $410 million, an increase of 8% compared to $378 million in 2023.

Current report

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

Current report

Profit from our United States segment in 2024 was $2,296 million, a decrease of 4% compared to $2,394 million in 2023. This decrease was mainly due to higher operational expenses, partially offset by higher revenues, as discussed above.

Current report

AJOVY revenues in our Europe segment in 2024 were $216 million, an increase of 34%, in both U.S. dollars and local currency terms, compared to 2023. This increase was due to growth in volumes.

Current report

Gross profit from our Europe segment in 2024 was $2,905 million, an increase of 7% compared to $2,726 million in 2023.

Current report

Gross profit margin for our Europe segment in 2024 increased to 56.9%, compared to 56.4% in 2023, mainly due to a positive impact from hedging activities, as well as a decrease in our operational costs.

Current report

R&D expenses relating to our Europe segment in 2024 were $229 million, an increase of 4% compared to $220 million in 2023.

Current report

G&A expenses relating to our Europe segment in 2024 were $272 million, an increase of 3% compared to $263 million in 2023.

Current report

Profit from our Europe segment in 2024 was $1,575 million, an increase of 7% compared to $1,478 million in 2023, mainly due to higher revenues in 2024, partially offset by higher S&M expenses.

Current report

On December 5, 2024, we announced that we entered into an agreement with JKI Co. Ltd., established by the fund managed and operated by private equity firm J-Will Partners Co. Ltd., to sell our Teva-Takeda business venture in Japan, which includes generic products and legacy products, with an expected closing date of April 1, 2025, subject to standard closing conditions. See notes 2 and 22 to our consolidated financial statements.

Current report

COPAXONE revenues in our International Markets segment in 2024 decreased by 24% to $48 million, compared to 2023. In local currency terms, revenues decreased by 11%, mainly due to market share erosion and competition.

Current report

AUSTEDO revenues in our International Markets segment in 2024 were $46 million. In local currency terms, revenues increased by 205%, substantially due to the launch of a strategic partnership in China.

Current report

Gross profit from our International Markets segment in 2024 was $1,235 million, an increase of 6% compared to $1,160 million in 2023.

Current report

R&D expenses relating to our International Markets segment in 2024 were $112 million, an increase of 7% compared to $104 million in 2023.

Current report

G&A expenses relating to our International Markets segment in 2024 were $150 million, an increase of 5% compared to $142 million in 2023.

Current report

API sales to third parties in 2024 were $553 million, reflecting an increase of 3% in both U.S. dollars and local currency terms compared to 2023, following a reallocation of an immaterial business within our other activities, in line with our intention to divest our API business.

Current report

G&A expenses in 2024 were $1,161 million, flat compared to 2023.

Current report

Net loss attributable tonon-controlling interests was $320 million in 2024, compared to a net loss attributable tonon-controlling interests of $56 million in 2023. The higher net loss in 2024 was mainly due to higher impairments of tangible assets largely related to the classification of our business venture in Japan as held for sale. See note 15 to our consolidated financial statements.

Showing the first 40 of 50 passages. Open the source sections for the rest.

Removed paragraphs (44)

Previous report

We are a global pharmaceutical company, committed to helping patients around the world to access affordable medicines and benefit from innovations to improve their health. Our mission is to be a global leader in generics, innovative medicines and biopharmaceuticals, improving the lives of patients.

Previous report

In May 2023, we introduced our new “Pivot to Growth” strategy, which is based on four key pillars: (i) delivering on our growth engines, mainly AUSTEDO, AJOVY, UZEDY and our late-stage pipeline of biosimilars; (ii) stepping up innovation through delivering on our late-stage innovative pipeline assets as well as building up our early-stage pipeline organically and potentially through business development activities; (iii) sustaining our generics medicines powerhouse with a global commercial footprint, focused portfolio, pipeline and manufacturing footprint; and (iv) focusing our business by optimizing our portfolio and global manufacturing footprint to enable strategic capital deployment to accelerate our near and long-term growth engines and reorganizing certain of our business units to a more optimal structure, while also reorganizing key business units to enhance operational efficiency.

Previous report

The following table presents revenues, expenses and profit for our North America segment for the past two years:

Previous report

Revenues from our North America segment in 2023 were $8,124 million, an increase of $672 million, or 9%, compared to 2022, mainly due to an upfront payment received in connection with the collaboration on our anti-TL1A asset, higher revenues from our innovative products AUSTEDO and AJOVY, as well as higher revenues from Anda, partially offset by lower revenues from BENDEKA and TREANDA, COPAXONE and from generic products.

Previous report

The following table presents revenues for our North America segment by major products and activities for the past two years:

Previous report

Generic products revenues (including biosimilars) in our North America segment in 2023 decreased by 2% to $3,475 million, compared to 2022, mainly due to increased competition to parts of our portfolio, partially offset by revenues from lenalidomide capsules (the generic version of Revlimid®) and other generic launches in 2023.

Previous report

On March 9, 2023, Teva and Natco Pharma Ltd. announced the launch of additional strengths for lenalidomide capsules (the generic equivalent of Revlimid®) in the U.S. in 2.5 mg and 20 mg strengths.

Previous report

During the fourth quarter of 2023, we received approval in the U.S. for the following complex generics: Teriparitide Injection (generic version of Forteo®) for the treatment of osteoporosis in adults, Risperidone for extended-release injectable suspension (generic version of Risperdal Consta long-acting injection) for the treatment of schizophrenia, Octreotide Acetate (generic version of Sandostatin®) which is used for acromegaly or diarrhea associated with metastatic carcinoid tumors or Vasoactive Intestinal Peptide (VIP) secreting tumors, and Cyclosporine Ophthalmic Emulsion (generic version of Restasis®) which is used to increase tear production.

Previous report

Anda revenues from third parties in our North America segment in 2023 increased by 7% to $1,577 million compared to 2022, mainly due to higher demand.

Previous report

Gross profit from our North America segment in 2023 was $4,421 million, an increase of 13% compared to $3,926 million in 2022.

Previous report

R&D expenses relating to our North America segment in 2023 were $625 million, an increase of 18% compared to $532 million in 2022.

Previous report

G&A expenses relating to our North America segment in 2023 were $403 million, a decrease of 15% compared to $474 million in 2022. This decrease was mainly due to lower litigation fees in 2023.

Previous report

Profit from our North America segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Previous report

Profit from our North America segment in 2023 was $2,396 million, an increase of 20% compared to $1,993 million in 2022. This increase was mainly due to higher revenues, partially offset by higher R&D and S&M expenses, as discussed above.

Previous report

AJOVY revenues in our Europe segment in 2023 increased by 29% to $160 million, compared to 2022. In local currency terms, revenues increased by 27% due to higher volumes.

Previous report

Gross profit from our Europe segment in 2023 was $2,726 million, an increase of 1% compared to $2,700 million in 2022.

Previous report

Gross profit margin for our Europe segment in 2023 decreased to 56.4%, compared to 59.7% in 2022, mainly due to higher cost of goods sold primarily due to inflationary and other macroeconomic pressures, and a negative impact of hedging activities, partially offset by revenues from the sale of certain product rights in 2023.

Previous report

R&D expenses relating to our Europe segment in 2023 were $220 million, an increase of 3% compared to $213 million in 2022.

Previous report

G&A expenses relating to our Europe segment in 2023 were $263 million, an increase of 7% compared to $246 million in 2022. This increase was mainly due to higher litigation fees in 2023 and exchange rate fluctuations.

Previous report

Profit from our Europe segment in 2023 was $1,478 million, a decrease of 1% compared to $1,496 million in 2022.

Previous report

COPAXONE revenues in our International Markets segment in 2023 increased by 9% to $39 million, compared to 2022. In local currency terms, revenues increased by 25%.

Previous report

R&D expenses relating to our International Markets segment in 2023 were $83 million, an increase of 16% compared to $72 million in 2022.

Previous report

G&A expenses relating to our International Markets segment in 2023 were $118 million, a decrease of 1% compared to $119 million in 2022.

Previous report

API sales to third parties in 2023 were $568 million, a decrease of 16% in both U.S. dollars and local currency terms, mainly due to changes in market conditions.

Previous report

Gross profit margin was 48.2% in 2023, compared to 46.7% in 2022.

Previous report

G&A expenses in 2023 were $1,162 million, a decrease of 2% compared to 2022.

Previous report

Share in profits of associated companies, net was $2 million in 2023, compared to $21 million in 2022. Share in profits of associated companies, net in 2022 was mainly related to the difference between the book value of our investment in Novetide and its fair value as of the date we completed its acquisition in January 2022.

Previous report

In computing diluted loss per share for the year ended December 31, 2023 and 2022, no account was taken of the potential dilution that could occur upon the exercise of options andnon-vested restricted share units (“RSUs”) and performance share units (“PSUs”) granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.

Previous report

As of December 31, 2023, our debt was $19,833 million, compared to $21,212 million as of December 31, 2022. This decrease was mainly due to $1,646 million senior notes repaid at maturity, partially offset by $302 million of exchange rate fluctuations. Additionally, during the first quarter of 2023, we repurchased $2,506 million aggregate principal amount of notes upon consummation of a cash tender offer and issued $2,445 million of sustainability-linked senior notes, net of issuance costs. For further information, see note 9 to our consolidated financial statements.

Previous report

In April 2022, Teva repaid $296 million of its 3.25% senior notes at maturity.

Previous report

In July 2022, Teva repaid $365 million of its 0.50% senior notes at maturity.

Showing the first 40 of 44 passages. Open the source sections for the rest.

Reworded paragraphs (90)

Previous wording

We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Our key strengths include our world-leading generic medicines expertise and portfolio, focused innovative medicines portfolio and global infrastructure and scale.

Current wording

We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Today, our global network of capabilities enables our approximately 37,000 employees across 57 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes for millions of patients every day.

Previous wording

We operate our business through three segments: North America, Europe and International Markets. Each business segment manages our entire product portfolio in its region, including generics, which includes biosimilars and OTC products, as well as innovative medicines. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.

Current wording

We operate our business through three segments: United States (previously referred to as the North America segment, see below “—United States Segment”), Europe and International Markets. Each business segment manages our entire product portfolio in its region, including generics, which includes biosimilars and OTC products, as well as innovative medicines. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.

Previous wording

In recent years, the global economy has been impacted by fluctuating foreign exchange rates. Approximately 47% of our revenues are denominated in currencies other than the U.S. dollar and we manufacture our products largely outside of the United States. Fluctuations in the U.S. dollar versus other currencies in which we operate may materially impact our revenues, results of operations, profits and cash flows. Additionally, high levels of inflation have recently resulted in significant economic volatility and monetary tightening by central banks through increasing interest rates. In addition to rising inflation, heightened interest rates and fluctuating foreign exchange rates, the global economy has also been impacted by geopolitical tensions which have resulted in disruptions to global supply chains, including to our internal supply chain. In October 2023, Israel was attacked by a terrorist organization and entered a state of war. Our global headquarters as well as several of our manufacturing and R&D facilities are located in Israel and, while operations there currently remain largely unaffected, the impact of this war on our operations may increase, which could be material, as a result of the continuation, escalation or expansion of this war. In light of the above, supply chain disruptions could continue to result in delays in our production and distribution processes, R&D initiatives and our ability to timely respond to consumer demand. We have implemented certain measures in response to such macroeconomic pressures and geopolitical events and are continually considering various initiatives, including price adjustments where we are not restricted contractually or regulatorily, enhanced inventory management, alternative sourcing strategies for our raw material supply and backup production plans for key products, to allow us to partially mitigate and offset the impact of these macroeconomic and geopolitical factors. However, although inflationary and other macroeconomic pressures may ease, the higher costs we have experienced during the recent periods have already impacted our operations and will likely continue to have an effect on our financial results.

Current wording

In recent years, the global economy has been impacted by fluctuating foreign exchange rates. In 2024, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar and we manufacture our products largely outside of the United States. Fluctuations in the U.S. dollar versus other currencies in which we operate may materially impact our revenues, results of operations, profits and cash flows. Additionally, in recent years, in many of the markets in which we operate we experienced higher levels of inflation resulting in higher interest rates, though in certain other markets, such as the EU, we recently experienced a decrease in inflation which resulted in lower interests rates. The global economy has also been impacted by geopolitical tensions which have resulted in disruptions to global supply chains, including our internal supply chain. In October 2023, Israel was attacked by a terrorist organization and entered a state of war on several fronts, which as of the date of this Annual Report on Form 10-K is ongoing. Our global headquarters as well as several of our manufacturing and R&D facilities are located in Israel and, while operations there currently remain largely unaffected, the impact of this war on our operations may increase, which could be material, as a result of the continuation, escalation or expansion of this war. In light of the above, supply chain disruptions could continue to result in delays in our production and distribution processes, R&D initiatives and our ability to timely respond to consumer demand. We have implemented certain measures in response to such events and are continually considering various initiatives, including price adjustments where we are not restricted contractually or regulatorily, enhanced inventory management, alternative sourcing strategies for our raw material supply and backup production plans for key products, to allow us to partially mitigate and offset the impact of these macroeconomic and geopolitical factors. However, although inflationary and other macroeconomic pressures have and may continue to ease, the higher costs we have experienced during recent periods have already impacted our operations and will likely continue to have an effect on our financial results.

Previous wording

As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada will be reported under our International Markets segment and will no longer be included as part of our North America segment. See note 19 to our consolidated financial statements.

Current wording

As part of a recent shift in executive management responsibilities and in line with our Pivot to Growth strategy, commencing January 1, 2024, Canada is reported as part of our International Markets segment. Prior period amounts were recast to reflect this change. See note 19 to our consolidated financial statements.

Previous wording

Among the most significant generic products we sold in North America in 2023 were lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®), Truxima® (the biosimilar to Rituxan®) and albuterol sulfate inhalation aerosol (our ProAir® authorized generic).

Current wording

Among the most significant generic products we sold in the United States in 2024 were lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®), Truxima® (the biosimilar to Rituxan®) and liraglutide 1.8 mg injection (an authorized generic of Victoza®).

Previous wording

In 2023, our total prescriptions were approximately 318 million (based on trailing twelve months), representing 8.4% of total U.S. generic prescriptions according to IQVIA data.

Current wording

In 2024, our total prescriptions were approximately 283 million (based on trailing twelve months), representing 7.4% of total U.S. generic prescriptions according to IQVIA data.

Previous wording

AJOVY revenues in our North America segment in 2023 increased by 6% to $230 million, compared to 2022, mainly due to growth in volume, partially offset by unfavorable net pricing. In 2023, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 24.5%, compared to 26.0% in 2022.

Current wording

AJOVY revenues in our United States segment in 2024 decreased by 2% to $207 million, compared to 2023, mainly due to unfavorable net pricing including an increase in sales allowance due to anon-recurring item, partially offset by growth in volume. In 2024, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 29.6%, compared to 25.7% in 2023.

Previous wording

AUSTEDO revenues in our North America segment in 2023 increased by 27% to $1,225 million, compared to 2022, mainly due to growth in volume including the launch of AUSTEDO XR in May 2023.

Current wording

AUSTEDO revenues in our United States segment in 2024 increased by 34% to $1,642 million, compared to 2023, mainly due to growth in volume including the launch of AUSTEDO XR in May 2023, as well as expanded access for patients.

Previous wording

BENDEKAand TREANDA combined revenues in our North America segment in 2023 decreased by 24% to $241 million compared to 2022, mainly due to generic bendamustine products entry into the market. The orphan drug exclusivity that was attached to bendamustine products expired in December 2022.

Current wording

BENDEKAand TREANDA combined revenues in our United States segment in 2024 decreased by 29% to $168 million, compared to 2023, mainly due to competition from alternative therapies, as well as the entry of generic bendamustine products into the market. The orphan drug exclusivity that was attached to bendamustine products expired in December 2022.

Previous wording

COPAXONE revenues in our North America segment in 2023 decreased by 17% to $320 million, compared to 2022, mainly due to generic competition in the United States and a decrease in glatiramer acetate market share due to availability of alternative biologic therapies, partially offset by a reduction in sales allowance.

Current wording

COPAXONE revenues in our United States segment in 2024 decreased by 18% to $242 million, compared to 2023, mainly due to market share erosion and competition, partially offset by a reduction in sales allowance.

Previous wording

In 2023, we launched the generic version of the following branded products in the United States:

Current wording

In 2024, we launched the generic version and biosimilar version of the following branded products in the United States:

Previous wording

As of December 31, 2023, our generic products pipeline in the United States includes 137 product applications awaiting FDA approval, including 63 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended September 30, 2023 of approximately $107 billion, according to IQVIA. Approximately 78% of pending applications include a paragraph IV patent challenge and we believe we are first to file with respect to 62 of these products, or 88 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first to file opportunities represent over $72 billion in U.S. brand sales for the twelve months ended September 30, 2023, according to IQVIA.

Current wording

As of December 31, 2024, our generic products pipeline in the United States includes 127 product applications awaiting FDA approval, including 65 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended September 30, 2024 of approximately $122 billion, according to IQVIA. Approximately 78% of pending applications include a paragraph IV patent challenge and we believe we are first to file with respect to 54 of these products, or 82 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first to file opportunities represent over $80 billion in U.S. brand sales for the twelve months ended September 30, 2024, according to IQVIA.

Previous wording

Gross profit from our International Markets segment in 2023 was $1,050 million, an increase of 2% compared to $1,033 million in 2022.

Current wording

Gross profit from our United States segment in 2024 was $4,388 million, an increase of 2% compared to $4,310 million in 2023.

Previous wording

Gross profit margin for our North America segment in 2023 increased to 54.4%, compared to 52.7% in 2022. This increase was mainly due to an upfront payment received in connection with the collaboration on our anti-TL1A asset, as discussed above, as well as a favorable mix of products primarily driven by an increase in revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid®), partially offset by higher costs due to inflationary and other macroeconomic pressures.

Current wording

Gross profit margin for our United States segment in 2024 decreased to 54.6%, compared to 55.7% in 2023. This decrease was mainly due to an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, partially offset by a favorable mix of products primarily driven by higher revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid®).

Previous wording

S&M expenses relating to our North America segment in 2023 were $1,005 million, an increase of 7% compared to $941 million in 2022. This increase was mainly due to promotional and commercial activities related to AUSTEDO and UZEDY.

Current wording

S&M expenses relating to our United States segment in 2024 were $1,049 million, an increase of 12% compared to $938 million in 2023. This increase was mainly due to promotional activities related to AUSTEDO, primarily consisting of adirect-to-consumer advertising campaign and our patient support programs.

Previous wording

Our Europe segment includes the European Union, the United Kingdom and certain other European countries. Revenues from our Europe segment in 2023 were $4,837 million, an increase of $312 million, or 7%, compared to 2022. In local currency terms, revenues increased by 5%, mainly due to higher revenues from generic and OTC products as well as higher revenues from AJOVY, partially offset by lower revenues from COPAXONE and certain other respiratory products. Higher revenues from our Europe segment in 2023 were also driven by the sale of certain product rights.

Current wording

Revenues from our Europe segment in 2024 were $5,103 million, an increase of $266 million, or 5%, compared to 2023. In local currency terms, revenues increased by 4%, mainly due to higher revenues from generic and OTC products as well as higher revenues from AJOVY, partially offset by lower revenues from COPAXONE, respiratory products and other products. Our revenues in 2024 and 2023 were also impacted by the sale of certain product rights.

Previous wording

In 2023, revenues were positively impacted by exchange rate fluctuations of $88 million, net of hedging effects, compared to 2022. Revenues in 2023 were affected by a $12 million negative hedging impact, compared to a $17 million positive hedging impact in 2022, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.

Current wording

In 2024, revenues were positively impacted by exchange rate fluctuations of $64 million, including hedging effects, compared to 2023. Revenues in 2024 were affected by a $21 million positive hedging impact, compared to a $12 million negative hedging impact in 2023, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.

Previous wording

Generic products revenues (including OTC and biosimilar products) in our Europe segment in 2023 increased by 6% to $3,664 million compared to 2022. In local currency terms, revenues increased by 3%, mainly due to higher volumes and OTC price increases.

Current wording

Generic products revenues (including OTC and biosimilar products) in our Europe segment in 2024 increased by 7% to $3,926 million compared to 2023. In local currency terms, revenues increased by 6%, mainly due to price increases as a result of market conditions such as inflationary pressures in certain markets, as well as higher revenues from recently launched products.

Previous wording

COPAXONE revenues in our Europe segment in 2023 decreased by 14% to $231 million, compared to 2022. In local currency terms, revenues decreased by 16%, mainly due to price reductions and lower volumes resulting from competing glatiramer acetate products and availability of alternative therapies.

Current wording

COPAXONE revenues in our Europe segment in 2024 decreased by 8% to $213 million, compared to 2023, in both U.S. dollars and local currency terms, compared to 2023. This decrease was mainly due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products.

Previous wording

Respiratory products revenues in our Europe segment in 2023 decreased by 3% to $265 million, compared to 2022. In local currency terms, revenues decreased by 5%, mainly due to net price reductions and lower volumes.

Current wording

Respiratory products revenues in our Europe segment in 2024 decreased by 8% to $244 million, compared to 2023. In local currency terms, revenues decreased by 9%, mainly due to net price reductions and lower volumes.

Previous wording

As of December 31, 2023, our generic products pipeline in Europe included 442 generic approvals relating to 67 compounds in 124 formulations, no EMA approvals received during 2023. In addition, approximately 1,318 marketing authorization applications pending approval in 37 European countries, relating to 99 compounds in 214 formulations. Two applications are pending with the EMA.

Current wording

As of December 31, 2024, our generic products pipeline in Europe included 686 generic approvals relating to 71 compounds in 149 formulations and one EMA approval received during 2024. In addition, approximately 1,483 marketing authorization applications are pending approval in 37 European countries, which approvals relate to 92 compounds in 212 formulations. No applications are pending with the EMA.

Previous wording

S&M expenses relating to our Europe segment in 2023 were $767 million, an increase of 3% compared to $748 million in 2022. This increase was mainly to support revenue growth as well as due to exchange rate fluctuations.

Current wording

S&M expenses relating to our Europe segment in 2024 were $826 million, an increase of 8% compared to $767 million in 2023. This increase was mainly to support revenue growth.

Previous wording

Profit of our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Current wording

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

Previous wording

Our North America segment includes the United States and Canada. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada will be reported as part of our International Markets segment.

Current wording

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segments. The International Markets segment covers a substantial portion of the global pharmaceutical industry, including more than 35 countries. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada is reported under our International Markets segment and is no longer included as part of our United States segment. Prior period amounts were recast to reflect this change. See note 19 to our consolidated financial statements.

Previous wording

Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical market. The countries in our International Markets segment include highly regulated, pure generic markets, such as Israel, branded generics oriented markets, such as Russia and certain Latin American markets, and hybrid markets, such as Japan.

Current wording

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

Previous wording

In February 2022, Russia launched an invasion of Ukraine. As of the date of this Annual Report on Form 10-K, sustained conflict and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results. We have no manufacturing or R&D facilities in these markets. During the year ended December 31, 2023, the impact of this conflict on our International Markets segment’s results of operations and financial condition was immaterial. Consistent with our foreign exchange risk management hedging programs, we entered into hedges to hedge our exposure to currency exchange rate fluctuations with respect to our balance sheet assets, revenues and expenses. However, as of the end of 2023, we were unable to renew certain of our expiring hedging positions due to the liquidity situation in the market for Russian rubles. Prior to and since the escalation of the conflict, we have been taking measures to reduce our operational cash balances in Russia and Ukraine. We have been monitoring the solvency of our customers in Russia and Ukraine and have taken measures, where practicable, to mitigate our exposure to risks related to the conflict in the region. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the conflict cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets.

Current wording

As of the date of this Annual Report on Form 10-K, sustained conflict between Russia and Ukraine and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results and we have no manufacturing or R&D facilities in these markets. During the year ended December 31, 2024, the impact of this conflict on our International Markets segment’s results of operations and financial condition was immaterial. Consistent with our foreign exchange risk management hedging programs, in the year ended December 31, 2024, we partially hedged our exposure to currency exchange rate fluctuations with respect to our balance sheet assets, revenues and expenses. As of the end of 2024, we hedge a small part of our projected net revenues in Russian ruble for 2025. Prior to and since the escalation of the conflict, we have been taking measures to reduce our operational cash balances in Russia and Ukraine. We have been monitoring the solvency of our customers in Russia and Ukraine and have taken measures, where practicable, to mitigate our exposure to risks related to the conflict in the region. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the conflict cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets.

Previous wording

Revenues from our International Markets segment in 2023 were $1,958 million, an increase of $55 million, or 3% compared to 2022. In local currency terms, revenues increased by 16% compared to 2022, mainly due to higher revenues from generic products in most markets, partially offset by regulatory price reductions and generic competition tooff-patented products in Japan.

Current wording

Revenues from our International Markets segment in 2024 were $2,463 million, an increase of $112 million, or 5%, compared to 2023. In local currency terms, revenues increased by 18% compared to 2023, mainly due to higher revenues from generic products in most markets, partially offset by regulatory price reductions and generic competition tooff-patented products in Japan. The higher revenues in our International Markets segment in 2024 were impacted by the sale of certain product rights.

Previous wording

In 2023, revenues were negatively impacted by exchange rate fluctuations of $246 million, net of hedging effects, compared to 2022. Revenues in 2023 were affected by an $11 million positive hedging impact, compared to an $11 million negative hedging impact in 2022, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.

Current wording

In 2024, revenues were negatively impacted by exchange rate fluctuations of $321 million net of hedging effects, compared to 2023. Revenues in 2024, were affected by a $13 million positive hedging impact, compared to a $9 million positive hedging impact in 2023, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.

Previous wording

Generic products revenues (including OTC products) in our International Markets segment in 2023 increased by 1% to $1,594 million, compared to 2022. In local currency terms, revenues increased by 16%, mainly due to higher revenues in most markets, as well as price increases largely as a result of higher costs due to inflationary pressure, partially offset by regulatory price reductions and generic competition tooff-patented products in Japan.

Current wording

Generic products revenues (including OTC and biosimilar products) in our International Markets segment in 2024 were flat, compared to 2023. In local currency terms, revenues increased by 15%, mainly due to higher revenues in most markets, as well as price increases, largely as a result of higher costs due to inflationary pressure, partially offset by regulatory price reductions and generic competition tooff-patented products in Japan.

Previous wording

AJOVY was launched by the end of 2023 in certain countries within our International Markets segment, including in Japan, Australia, Israel, South Korea, Brazil and others. We are moving forward with plans to launch AJOVY in other markets. AJOVY revenues in our International Markets segment in 2023 increased by 25% to $44 million, compared to 2022. In local currency terms, revenues increased by 35%.

Current wording

AJOVY was launched in certain countries in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in 2024 increased by 33% to $84 million, compared to 2023. In local currency terms, revenues increased by 39%, due to growth in existing markets in which AJOVY was launched.

Previous wording

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.

Current wording

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. We continue to pursue additional submissions in various other markets.

Previous wording

Gross profit margin for our International Markets segment in 2023 decreased to 53.6%, compared to 54.3% in 2022. This decrease was mainly due to regulatory price reductions and generic competition tooff-patented products in Japan, partially offset by price increases largely as a result of higher costs due to inflationary pressure, a favorable mix of products sold and a positive hedging impact.

Current wording

Gross profit margin for our International Markets segment in 2024 increased to 50.1%, compared to 49.4% in 2023. This increase was mainly due to the sale of certain product rights, price increases largely as a result of higher costs due to inflationary pressure, a favorable mix of products sold, and a positive hedging impact, partially offset by regulatory price reductions and generic competition tooff-patented products in Japan.

Previous wording

S&M expenses relating to our International Markets segment in 2023 were $420 million, an increase of 4% compared to $405 million in 2022, mainly to support revenue growth.

Current wording

S&M expenses relating to our International Markets segment in 2024 were $534 million, an increase of 10% compared to $487 million in 2023, mainly to support revenue growth, including through our strategic partnership in China for AUSTEDO.

Previous wording

Other income relating to our International Markets segment in 2023 was $35 million, compared to $43 million in 2022. Other income in 2023 was mainly the result of a capital gain from the sale of assets. Other income in 2022 was mainly the result of settlement proceeds.

Current wording

Other income relating to our International Markets segment in 2023 was $2 million, compared to $39 million in 2023. Other income in 2023 was mainly the result of a capital gain from the sale of assets.

Previous wording

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

Current wording

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

Previous wording

Profit from our International Markets segment in 2023 was $464 million a decrease of 3% compared to $479 million in 2022. This decrease was mainly due to higher S&M and R&D expenses and lower other income.

Current wording

Profit from our International Markets segment in 2024 was $440 million a decrease of 5% compared to $465 million in 2023. This decrease was mainly due to higher S&M expenses, lower other income and higher R&D expenses.

Previous wording

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

Current wording

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

Previous wording

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, which divestment is expected to be completed in the first half of 2025. The intention to divest is in alignment with our Pivot to Growth strategy. 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.

Current wording

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. However, there can be no assurance regarding the ultimate timing or structure of the potential divestiture or that a divestiture will be agreed or completed at all. For further information, see note 2 to our consolidated financial statements.

Previous wording

Our revenues from other activities in 2023 were $926 million, a decrease of 11% in U.S. dollars, or 12% in local currency terms, compared to 2022.

Current wording

Our revenues from other activities in 2024 were $944 million, an increase of 2% in both U.S. dollars and local currency terms, compared to 2023.

Previous wording

Revenues in 2023 were $15,846 million, an increase of 6%, in U.S. dollars or 7% in local currency terms, compared to 2022. This increase was mainly due to an upfront payment received in connection with the collaboration on our anti-TL1A asset, higher revenues from generic products in our International Markets and Europe segments, from our innovative products AUSTEDO and AJOVY, the sale of certain product rights in our Europe segment, as well as higher revenues from Anda, partially offset by lower revenues from COPAXONE, API sales to third parties, BENDEKA and TREANDA, and generic products in our North America segment. See “—North America Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.

Current wording

Revenues in 2024 were $16,544 million, an increase of 4%, in U.S. dollars or 6% in local currency terms, compared to 2023. This increase was mainly due to higher revenues from generic products in all our segments, including from lenalidomide capsules (the generic version of Revlimid®) in our U.S. segment, from our innovative products AUSTEDO, UZEDY and AJOVY, as well as the sale of certain product rights, partially offset by an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, and lower revenues from certain innovative products, primarily COPAXONE and BENDEKA and TREANDA. See “—United States Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.

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Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

In October 2023, Israel was attacked by a terrorist organization and entered a state of war. For additional information see “—Macroeconomic and Geopolitical Environment” above and note 1 to our consolidated financial statements.

Previous report — wording carried elsewhere

Our G&A expenses were primarily the result of the factors discussed above under “—North America Segment—G&A Expenses” and “—Europe Segment— G&A Expenses.”

Previous report — wording carried elsewhere

We perform an impairment test annually and whenever events or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable. The provisions of the accounting standard for goodwill allow us to first assess qualitative factors to determine whether it is necessary to perform the next goodwill impairment quantitative test.