Teva Delivers Second Consecutive Year of Growth; Announces Strong Financial Results in Fourth Quarter and Full Year 2024, Led by Generics Performance and Innovative Portfolio Growth
January 29, 2025
- 2024 Revenues of $16.5 billion reflect an increase of 6%, in local currency terms, compared to 2023;
- AUSTEDO® - exceeding $1.6 billion in revenues, surpassing 2024 outlook;
- AJOVY® - global annual revenues of $507 million, an increase of 18% in local currency terms compared to 2023;
- UZEDY® revenues of $117 million in 2024 surpassing $100M outlook;
- Generics business continues to grow across all segments, with increases of 15% in the U.S., 6% in Europe and 15% in International Markets, all in local currency terms compared to 2023;
- First-to-market launches including first generic version of Sandostatin® LAR Depot and liraglutide injection 1.8mg (an authorized generic of Victoza®); On January 2025, Teva entered into a license and supply agreement, for a proposed generic GLP1 in the U.S., Europe and additional countries;
- Biosimilar pipeline is expanding, and now includes 18 assets, including SELARSDITM, which is expected to launch in the U.S. in the first quarter of 2025; and our first internally developed biosimilar to Prolia® (denosumab), which is under regulatory review in the U.S. and in Europe;
- Duvakitug (Anti-TL1A) positive Phase 2B results announced and initiation of Phase 3 program is expected in 2025; olanzapine LAI achieved Phase 3 targeted injections without PDSS (post-injection delirium/sedation syndrome), and full safety presentation is expected in the second quarter of 2025.
- Q4 2024 and FY 2024 highlights:
| Q4 2024 | FY 2024 | ||
| Revenues | $4.2 billion | $16.5 billion | |
| GAAP loss per share | $0.19 | $1.45 | |
| Non-GAAP diluted EPS | $0.71 | $2.49 | |
| Cash flow generated from operating activities | $575 million | $1,247 million | |
| Free cash flow | $790 million | $2,068 million | |
2025 Outlook *
- Revenues of $16.8 - $17.4 billion
- Non-GAAP operating income of $4.1-$4.6 billion
- Adjusted EBITDA of $4.5 - $5.0 billion
- Non-GAAP diluted EPS of $2.35 - $2.65
- Free cash flow of $1.6 - $1.9 billion
* 2025 outlook assumes a full year contribution from Teva api and our business venture in Japan and excludes the expected income from potential milestone payments from Sanofi in connection with the Phase 3 initiation of duvakitug.
TEL AVIV, Israel, Jan. 29, 2025 (GLOBE NEWSWIRE) -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the year and the quarter ended December 31, 2024.
Mr. Richard Francis, Teva's President and CEO, said: "2024 marked a transformative year for Teva, resulting in a second consecutive year of growth, driven by our generic products and key innovative products. Focusing on rigorous execution of our Pivot to Growth strategy throughout the year, we continued to achieve important milestones in each of its four pillars, including surpassing the outlook for our key innovative products, growing our generics business across all segments, and accelerating our early-stage innovative pipeline, including the positive Phase 2b results for our duvakitug (anti-Tl1A) asset. These results pave the way for pivotal trials in Crohn’s disease and ulcerative colitis, as well as, potentially, other Immunological and fibrotic indications beyond, in collaboration with our partner, Sanofi."
Mr. Francis continued, "In 2025, we anticipate further progress in our key innovative growth drivers, while also executing on our complex generics and biosimilars business, supported by new product launches. We are also excited to advance to Phase 3 trials for our duvakitug (anti-TL1A) asset."
Pivot to Growth Strategy
In 2024, we continued to execute on the four key pillars of our “Pivot to Growth” strategy, which we announced in May 2023.
- On the first pillar, delivering on our growth engines, we continued to show strong performance of our key innovative products, mainly AUSTEDO, AJOVY, and UZEDY, as well as on our late-stage pipeline of biosimilars, with the launches of SIMLANDI® (adalimumab-ryvk) injection and the expected launch of SELARSDI (ustekinumab-aekn) injection, and the progress we made on our proposed biosimilars to Prolia®(denosumab), Simponi® and Simponi Aria® (golimumab), which were submitted for regulatory review in the U.S. and the EU;
- On the second pillar, stepping up innovation through delivering on our late-stage innovative pipeline, we have been accelerating the development of certain key pipeline assets, including the recent positive Phase 2b results for duvakitug (anti-TL1A), and expect a number of milestones and data points for olanzapine LAI, and DARI (dual-action asthma rescue inhaler, ICS/SABA) in the near future;
- On the third pillar, sustaining our generics powerhouse with a global commercial footprint, focused portfolio, pipeline and manufacturing footprint, we continued to optimize our generics business and build a strong pipeline of biosimilars, with several successful launches of high-value complex generics in 2024; and
- Lastly, on our fourth pillar, focusing our business by optimizing our portfolio and global manufacturing footprint. This will enable strategic capital deployment, to accelerate our growth engines, and reorganize certain of our business units to a more optimal structure. We continued our efforts on capital allocation and disciplined cost management by focusing on debt repayment, and optimizing our working capital management.
- Teva continues to progress with the sale of its active-pharmaceutical ingredient (API) business and is engaged with prospective purchasers. The timing and structure of the planned transaction are subject to ongoing consideration and the consummation of the sale remains contingent on reaching a definitive agreement, subject to approval by Teva's Board of Directors. On December 31, 2024, Teva classified its API business (including its R&D, manufacturing and commercial activities) as held for sale.
2024 Annual Consolidated Results
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 of $500 million 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.
Exchange rate movements during 2024, net of hedging effects, negatively impacted overall revenues by $257 million, operating income by $103 million and non-GAAP operating income by $104 million, each as compared to 2023.
Gross profit in 2024 was $8,064 million, an increase of 5% compared to 2023. Gross profit margin was 48.7% in 2024, compared to 48.2% in 2023. This increase in gross profit margin was mainly due to a favorable mix of products, primarily driven by higher revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid®), and 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. Non-GAAP gross profit was $8,814 million in 2024, an increase of 4% compared to 2023. Non-GAAP gross profit margin was 53.3% in 2024, compared to 53.5% in 2023. This decrease was mainly due to an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, and lower revenues from COPAXONE, partially offset by higher revenues from AUSTEDO, the sale of certain product rights, as well as higher revenues from lenalidomide capsules (the generic version of Revlimid®).
Research and Development (R&D) expenses, net in 2024 were $998 million, an increase of 5% compared to $953 million in 2023, as we continue to execute on our Pivot to Growth strategy. Our higher R&D expenses, net in 2024, compared to 2023, were mainly due to an increase in immunology and in immuno-oncology, our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), and our biosimilars pipeline, partially offset by a decline in various generics projects. Our R&D expenses, net in 2024 were also impacted positively by reimbursements from our strategic partnerships entered in 2023 and 2024.
Selling and Marketing (S&M) expenses in 2024 were $2,541 million, an increase of 9% compared to 2023. This increase was mainly to support revenue growth.
General and Administrative (G&A) expenses in 2024 were $1,161 million, flat compared to 2023.
Other income in 2024 was $14 million, compared to $49 million in 2023. Other income in 2023 included a capital gain from the sale of assets in our International Markets segment.
Operating loss was $303 million in 2024, compared to operating income of $433 million in 2023. Operating loss as a percentage of revenues was 1.8% in 2024, compared to operating income as a percentage of revenues of 2.7% in 2023. This decrease was mainly due to higher goodwill and other assets impairment charges as well as increased S&M expenses, partially offset by higher gross profit and lower legal settlements and loss contingencies. Non-GAAP operating income was $4,329 million in 2024, representing a non-GAAP operating margin of 26.2% compared to $4,361 million, representing a non-GAAP operating margin of 27.5% of revenues in 2023. The decrease in non-GAAP operating margin was mainly due to higher operating expenses as a percentage of revenues, as well as lower non-GAAP gross profit margin, as discussed above.
In 2024, financial expenses, net were $981 million, compared to $1,057 million in 2023. Financial expenses in 2024 and 2023 were mainly comprised of net-interest expenses of $915 million, and $961 million, respectively.
In 2024, we recognized a tax expense of $676 million on a pre-tax loss of $1,284 million. In 2023, we recognized a tax benefit of $7 million, on a pre-tax loss of $624 million. Our effective tax rate is the result of a variety of factors, including the geographic mix and type of products sold during the year, different effective tax rates applicable to non-Israeli subsidiaries that have tax rates different than Teva’s average tax rate, a settlement agreement with the Israeli Tax Authorities, impairment charges with no corresponding tax effects, net deferred tax benefits from intellectual property related integration plans, an adjustment to the Company’s corporate tax rate in Israel on losses related to non-qualified tax incentive activities in Israel, adjustments to valuation allowances on deferred tax assets, adjustments to uncertain tax positions and interest expense disallowances.
Non-GAAP tax rate for 2024 was 15.3%, compared to 13.0% in 2023. Our non-GAAP tax rate of 2024 was the result of a variety of factors, including the geographic mix and type of products sold during the year, different effective tax rates applicable to non-Israeli subsidiaries that have tax rates different than Teva’s average tax rate, net deferred tax benefits from intellectual property-related integration plans, adjustments to valuation allowances on deferred tax assets, adjustments to uncertain tax positions and interest expense disallowances.
Net loss attributable to Teva and loss per share in 2024 were $1,639 million and $1.45, respectively, compared to net loss attributable to Teva of $559 million and loss per share of $0.50, respectively, in 2023. The change in net loss attributable to Teva was mainly due to higher income taxes, as well as higher operating loss in 2024, partially offset by higher net loss attributable to non-controlling interests. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in 2024 were $2,860 million and $2.49, respectively, compared to $2,898 million and $2.56 in 2023.
Adjusted EBITDA was $4,781 million in 2024, compared to $4,818 million in 2023.
As of December 31, 2024 and 2023, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,174 million and 1,157 million, respectively.
Non-GAAP information: net non-GAAP adjustments in 2024 were $4,499 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the year were adjusted to exclude the following items:
- Amortization of purchased intangible assets totaling $588 million, of which $543 million is included in cost of goods sold and the remaining $45 million in S&M expenses;
- Legal settlements and loss contingencies of $761 million mainly related to a provision of $357 million recorded in connection with a decision by the European Commission in its antitrust investigation into COPAXONE, and $278 million related to an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments and the settlement agreement with the city of Baltimore);
- Goodwill impairment charges of $1,280 million related to the Teva API reporting unit;
- Impairment of long-lived assets of $1,275 million mainly related to the classification of our business venture in Japan and our API business as held for sale;
- Restructuring expenses of $74 million;
- Equity compensation expenses of $123 million;
- Contingent consideration expenses of $303 million;
- Gain on sale of business of $15 million;
- Accelerated depreciation of $13 million;
- Financial expenses of $49 million;
- Items attributable to non-controlling interests of $339 million;
- Other non-GAAP items of $229 million; and
- Corresponding tax effects and unusual tax items expenses of $157 million.
We believe that excluding such items facilitates investors’ understanding of our business including underlying performance 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 in 2024 was $1,247 million, compared to $1,368 million in 2023. The decrease in 2024 resulted mainly from an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, a negative impact from accounts payables, the classification of payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®) as cash flow used in operating activities, and higher tax payments, partially offset by higher profits from AUSTEDO and from the sale of certain product rights, lower inventory levels, and a positive impact from accounts receivables.
During 2024, we generated free cash flow of $2,068 million, which we define as comprising $1,247 million in cash flow generated from operating activities, $1,291 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $43 million proceeds from divestitures of businesses and other assets, partially offset by $498 million in cash used for capital investments and $15 million in cash used for acquisition of businesses, net of cash acquired.
During 2023, we generated free cash flow of $2,387 million, which we define as comprising $1,368 million in cash flow generated from operating activities, $1,477 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $68 million proceeds from divestitures of businesses and other assets, partially offset by $526 million in cash used for capital investments. The decrease in 2024 resulted mainly from lower cash flow generated from operating activities.
As of December 31, 2024, our debt was $17,783 million, compared to $19,833 million as of December 31, 2023. This decrease was mainly due to the repayment at maturity of $1,641 million of our senior notes and $429 million of exchange rate fluctuations. The portion of total debt classified as short-term as of December 31, 2024 was 10%, compared to 8% as of December 31, 2023.
Our average debt maturity was approximately 5.5 years as of December 31, 2024, compared to 6.0 years as of December 31, 2023.
Fourth Quarter 2024 Consolidated Results
Revenues in fourth quarter of 2024 were $4,229 million, a decrease of 5% in both U.S. dollars and in local currency terms, compared to the fourth quarter of 2023. This decrease was mainly due to an upfront payment of $500 million received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, partially offset by higher revenues from our innovative products AUSTEDO, UZEDY and AJOVY, from generic products in all our segments and from the sale of certain product rights.
Exchange rate movements during the fourth quarter of 2024, net of hedging effects, negatively impacted overall revenues by $8 million, compared to the fourth quarter of 2023.
Gross profit in the fourth quarter of 2024 was $2,120 million, a decrease of 12% compared to $2,416 million in the fourth quarter of 2023. Gross profit margin was 50.1% in the fourth quarter of 2024, compared to 54.2% in the fourth quarter of 2023. Non-GAAP gross profit was $2,319 million in the fourth quarter of 2024, a decrease of 11%, compared to $2,592 million in the fourth quarter of 2023. Non-GAAP gross profit margin was 54.8% in the fourth quarter of 2024, compared to 58.2% in the fourth quarter of 2023. The decrease in both gross profit margin and non-GAAP gross profit margin was mainly due to the upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, as well as lower revenues from COPAXONE, partially offset by higher revenues from AUSTEDO, as well as the sale of certain product rights.
Research and Development (R&D) expenses, net in the fourth quarter of 2024 were $248 million, an increase of 9% compared to $227 million in the fourth quarter of 2023, as we continue to execute on our Pivot to Growth strategy. Our higher R&D expenses, net in the fourth quarter of 2024 compared to the fourth quarter of 2023, were mainly due to an increase in our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), in immunology, and in immuno-oncology.
Selling and Marketing (S&M) expenses in the fourth quarter of 2024 were $650 million, an increase of 7% compared to the fourth quarter of 2023. This increase was mainly to support revenue growth in our innovative portfolio, primarily AUSTEDO, generic products and AJOVY.
General and Administrative (G&A) expenses in the fourth quarter of 2024 were $302 million, an increase of 4% compared to the fourth quarter of 2023.
Other loss (income) in the fourth quarter of 2024 was a loss of $8 million, compared to an income of $6 million in the fourth quarter of 2023.
Operating loss in the fourth quarter of 2024 was $29 million, compared to an operating income of $755 million in the fourth quarter of 2023. Operating loss as a percentage of revenues was 0.7% in the fourth quarter of 2024, compared to an operating income as a percentage of revenues of 17% in the fourth quarter of 2023. Non-GAAP operating income in the fourth quarter of 2024 was $1,168 million representing a non-GAAP operating margin of 27.6%, compared to non-GAAP operating income of $1,546 million representing a non-GAAP operating margin of 34.7% in the fourth quarter of 2023. The decrease in non-GAAP operating margin in the fourth quarter of 2024 was mainly due to an increase in operating expenses as a percentage of revenues, as well as due to lower non-GAAP gross profit margin, as discussed above.
Exchange rate movements during the fourth quarter of 2024, net of hedging effects, positively impacted our operating income and non-GAAP operating income by $21 million and $20 million, respectively, compared to the fourth quarter of 2023.
Financial expenses, net in the fourth quarter of 2024 were $218 million, mainly comprised of net-interest expenses of $224 million. In the fourth quarter of 2023, financial expenses, net were $249 million, mainly comprised of net-interest expenses of $238 million.
In the fourth quarter of 2024, we recognized a tax expense of $29 million, on a pre-tax loss of $247 million. In the fourth quarter of 2023, we recognized a tax expense of $43 million, on a pre-tax income of $507 million. Our effective tax rate for the fourth quarter of 2024 was the result of a variety of factors, including the geographic mix and type of products sold during the year, different effective tax rates applicable to non-Israeli subsidiaries that have tax rates different than Teva’s average tax rate, impairment charges with no corresponding tax effects, net deferred tax benefits from intellectual property related integration plans, adjustments to valuation allowances on deferred tax assets, adjustments to uncertain tax positions and interest expense disallowances.
Non-GAAP tax rate in the fourth quarter of 2024 was 14.8%, compared to 13.1% in the fourth quarter of 2023. Our non-GAAP tax rate in the fourth quarter of 2024 was the result of a variety of factors, including the geographic mix and type of products sold during the year, different effective tax rates applicable to non-Israeli subsidiaries that have tax rates different than Teva’s average tax rate, net deferred tax benefits from intellectual property related integration plans, adjustments to valuation allowances on deferred tax assets, adjustments to uncertain tax positions and interest expense disallowances.
Net loss attributable to Teva and loss per share in the fourth quarter of 2024 were $217 million and $0.19, respectively, compared to net income attributable to Teva and earning per share $461 million and $0.41, respectively, in the fourth quarter of 2023. The higher net loss in the fourth quarter of 2024 was mainly due to lower operating income, as discussed above.
Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the fourth quarter of 2024 were $816 million and $0.71, respectively, compared to $1,135 million and $1.00, respectively, in the fourth quarter of 2023.
Adjusted EBITDA was $1,282 million in the fourth quarter of 2024, a decrease of 23%, compared to $1,660 million in the fourth quarter of 2023.
Non-GAAP information: net non-GAAP adjustments in the fourth quarter of 2024 were $1,033 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the fourth quarter of 2024 were adjusted to exclude the following items:
- 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;
- An adjustment to impairment of long-lived assets of $517 million;
- Goodwill impairment charge of $280 million;
- Legal settlements and loss contingencies of $123 million;
- An adjustment to contingent consideration of $2 million;
- Equity compensation expenses of $34 million;
- Restructuring expenses of $22 million;
- Loss on sale of business of $6 million;
- Accelerated depreciation of $5 million;
- Financial expenses of $13 million;
- Other non-GAAP items of 67 million;
- Items attributable to non-controlling interests of $63 million; and
- Corresponding tax effects and unusual tax items of $114 million.
We believe that excluding such items facilitates investors’ understanding of our business including underlying performance 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 fourth quarter of 2024 was $575 million, compared to $1,184 million of cash flow generated from operating activities in the fourth quarter of 2023. The lower cash flow generated from operating activities in the fourth quarter of 2024 resulted mainly from changes in working capital items, including a negative impact of accounts payables, the classification of payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®) as cash flow used in operating activities, an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, partially offset by lower legal payments during the fourth quarter of 2024, mainly in connection with our opioids litigation.
During the fourth quarter of 2024, we generated free cash flow of $790 million, which we define as comprising $575 million in cash flow generated from operating activities, $340 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $4 million in divestitures of businesses and other assets, partially offset by $129 million in cash used for capital investment. During the fourth quarter of 2023, we generated free cash flow of $1,486 million, which we define as comprising $1,184 million in cash flow generated from operating activities, $421 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program), partially offset by $120 million in cash used for capital investment. This decrease resulted mainly from lower cash flow generated from operating activities.
Segment Results for the Fourth Quarter of 2024
United States Segment
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.
The following table presents revenues, expenses and profit for our United States segment for the three months ended December 31, 2024 and 2023:
| Three months ended December 31, | ||||||
| 2024 | 2023 | |||||
| (U.S. $ in millions / % of Segment Revenues) | ||||||
| Revenues | $ | 1,975 | 100% | $ | 2,266 | 100% |
| Cost of sales | 877 | 44.4% | 822 | 36.3% | ||
| Gross profit | 1,097 | 55.6% | 1,444 | 63.7% | ||
| R&D expenses | 158 | 8.0% | 144 | 6.3% | ||
| S&M expenses | 260 | 13.2% | 238 | 10.5% | ||
| G&A expenses | 109 | 5.5% | 90 | 4.0% | ||
| Other loss (income) | 1 | § | (1) | § | ||
| Segment profit* | $ | 569 | 28.8% | $ | 974 | 43.0% |
| * Segment profit does not include amortization and certain other items. § Represents an amount less than 0.5%. | ||||||
Revenues from our United States segment in the fourth quarter of 2024 were $1,975 million, a decrease of $291 million, or 13%, compared to the fourth quarter of 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 higher revenues from our innovative products AUSTEDO, and UZEDY, as well as the revenues from the sale of certain product rights.
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 December 31, 2024 and 2023:
| Three months ended December 31, | Percentage Change | |||||||
| 2024 | 2023 | 2024-2023 | ||||||
| (U.S. $ in millions) | ||||||||
| Generic products (including biosimilars) | $ | 674 | $ | 667 | 1% | |||
| AJOVY | 63 | 57 | 11% | |||||
| AUSTEDO | 518 | 408 | 27% | |||||
| BENDEKA and TREANDA | 41 | 52 | (21%) | |||||
| COPAXONE | 63 | 72 | (13%) | |||||
| UZEDY | 43 | 9 | N/A | |||||
| Anda | 402 | 394 | 2% | |||||
| Other* | 171 | 607 | (72%) | |||||
| Total | $ | 1,975 | $ | 2,266 | (13%) | |||
| *Other revenues in the fourth quarter of 2024 include the sale of certain product rights. Other revenues in the fourth quarter of 2023 were mainly comprised of a $500 million upfront payment received in connection with the collaboration on our duvakitug (anti-TL1A) asset. | ||||||||
Generic products (including biosimilars) revenues in our United States segment in the fourth quarter of 2024 were $674 million, an increase of 1% compared to the fourth quarter of 2023, the majorityof which is driven by the launch of liraglutide injection 1.8mg (an authorized generic of Victoza®) and higher revenues from Truxima® (the biosimilar to Rituxan®), partially offset by lower revenues from lenalidomide capsules (the generic version of Revlimid®) and albuterol sulfate inhalation aerosol (our ProAir® authorized generic).
Among the most significant generic products we sold in the United States in the fourth quarter of 2024 were Truxima® (the biosimilar to Rituxan®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®), and liraglutide 1.8 mg injection (an authorized generic of Victoza®).
In the fourth quarter of 2024, according to IQVIA data, our total prescriptions were approximately 68 million, representing 6.9% of total U.S. generic prescriptions.
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.
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. SELARSDI is expected to launch in the U.S. in the first quarter of 2025.
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.
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 metastatic non-small cell lung cancer, and the treatment of patients with metastatic adenocarcinoma of the pancreas.
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.
AJOVY revenues in our United States segment in the fourth quarter of 2024 were $63 million, an increase of 11% compared to the fourth quarter of 2023, mainly due to growth in volume, partially offset by unfavorable net pricing. In the fourth quarter of 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 the fourth quarter of 2023.
AUSTEDO revenues in our United States segment in the fourth quarter of 2024 increased by 27%, to $518 million, compared to $408 million in the fourth quarter of 2023, mainly due to growth in volume, as well as expanded access for patients.
AUSTEDO XR (deutetrabenazine) extended-release tablets were 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. In May 2024, the FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg. In July 2024, the FDA approved the 18 mg dosage for AUSTEDO XR, making it a one pill, once-daily option for all available doses. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional 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 fourth quarter of 2024 were $43 million. UZEDY was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023. UZEDY is a subcutaneous, long-acting formulation of risperidone that controls the steady release of risperidone. UZEDY is protected by four Orange Book patents expiring between 2027 and 2040. UZEDY is protected by regulatory exclusivity until April 28, 2026. We are moving forward with plans to launch UZEDY in other countries worldwide. UZEDY faces competition from multiple other products.
BENDEKA and TREANDA (bendamustine) combined revenues in our United States segment in the fourth quarter of 2024 were $41 million, a decrease of 21% compared to the fourth quarter of 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 had attached to bendamustine products expired in December 2022.
COPAXONE revenues in our United States segment in the fourth quarter of 2024 were $63 million, a decrease of 13% compared to the fourth quarter of 2023, mainly due to market share erosion and competition, partially offset by a reduction in sales allowance.
Anda revenues from third-party products in our United States segment in the fourth quarter of 2024 increased by 2% to $402 million, compared to $394 million in the fourth quarter of 2023, mainly due to higher volume. Anda, our distribution business in the United States, distributes generic, biosimilars 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.
United States Gross Profit
Gross profit from our United States segment in the fourth quarter of 2024 was $1,097 million, a decrease of 24%, compared to $1,444 million in the fourth quarter of 2023.
Gross profit margin for our United States segment in the fourth quarter of 2024 decreased to 55.6%, compared to 63.7% in the fourth quarter of 2023. This decrease was mainly due to an upfront payment received in the fourth quarter of 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, partially offset by a favorable mix of products, primarily driven by an increase in revenues from AUSTEDO and the sale of certain product rights.
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 any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our United States segment in the fourth quarter of 2024 was $569 million, a decrease of 42% compared to $974 million in the fourth quarter of 2023. The higher profit in the fourth quarter of 2023 was mainly due to an upfront payment received in relation to the collaboration on our duvakitug (anti-TL1A) asset.
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 December 31, 2024 and 2023: