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TEVA REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS AND REAFFIRMS 2024 FINANCIAL OUTLOOK
Q1 2024 Highlights:
Tel Aviv, May 8, 2024 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the quarter ended March 31, 2024.
Mr. Richard Francis, Teva s President and CEO , said, In 2024 Teva is off to a good start, with global revenues of $3.8 billion showing growth of 5% in local currency terms compared to Q1 2023, fueled by robust growth in our generics business across all regions, and continued growth of our innovative brands AUSTEDO and AJOVY.
Mr. Francis continued, As we mark the first anniversary of our Pivot to Growth Strategy, I am proud of the significant strides we have been making in realizing the goals and milestones we set out to achieve on our journey to growth, including the progression of our innovative pipeline and growth drivers, as well as the recent FDA approvals of SIMLANDI and SELARSDI, the biosimilars to Humira and Stelara , respectively, and
| IR Contacts | Ran Meir Yael Ashman Sanjeev Sharma | (215) 591-8912 +972 (3) 914 8262 (267) 658-2700 | ||
| PR Contacts | Kelley Dougherty Eden Klein | (973) 832-2810 +972 (3) 906 2645 |
the positive Phase 3 efficacy results for olanzapine Once-Monthly LAI announced this morning. The study met its primary endpoint, demonstrating a well-tolerated effective long-acting treatment option for schizophrenia, with no incidence of post-injection delirium/sedation syndrome (PDSS) observed to date.
As we continue to accelerate our growth progress, we reaffirm our financial guidance for 2024.
Pivot to Growth Strategy
In May 2023, we introduced our 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.
First Quarter 2024 Consolidated Results
The data presented in this press release with respect to operating income (loss), income (loss) before income taxes, income taxes (benefit), net income (loss) attributable to Teva and earnings (loss) per share for prior period has been revised to reflect a revision in relation to a contingent consideration and related expenses. For additional information, see note 1b to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 and note 1c to our consolidated financial statements included in our Quarterly Report on Form 10-Q for the period ended March 31, 2024.
Revenues in the first quarter of 2024 were $3,819 million, an increase of 4% in U.S. dollars or 5% in local currency terms compared to the first quarter of 2023. This increase was mainly due to higher revenues from generic products in all our segments, from AUSTEDO, as well as from AJOVY in our Europe and International Markets segments, partially offset by lower revenues from COPAXONE , and from Anda, our distribution business in the U.S.
Exchange rate movements during the first quarter of 2024, net of hedging effects, negatively impacted overall revenues by $39 million, compared to the first quarter of 2023. Exchange rate movements during the first quarter of 2024, including hedging effects, negatively impacted our operating income and non-GAAP operating income each by $11 million compared to the first quarter of 2023.
Gross profit in the first quarter of 2024 was $1,771 million, an increase of 12% compared to $1,582 million in the first quarter of 2023. Gross profit margin was 46.4% in the first quarter of 2024, compared to 43.2% in the first quarter of 2023. Non-GAAP gross profit was $1,963 million in the first quarter of 2024, an increase of 9% compared to $1,796 million in the first quarter of 2023. Non-GAAP gross profit margin was 51.4% in the first quarter of 2024, compared to 49.1% in the first quarter of 2023. The increase in both gross profit margin and non-GAAP gross profit margin was mainly due to a favorable mix of products as well as a decrease in our operational costs.
Research and Development (R&D) expenses, net in the first quarter of 2024 were $242 million, an increase of 4% compared to $234 million in the first quarter of 2023, as we continued to execute on our Pivot to Growth Strategy. Our higher R&D expenses, net in the first quarter of 2024, compared to the first quarter of 2023, were mainly due to an increase related to our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry) and in immunology and immuno-oncology. Our R&D expenses, net in the first quarter of 2024 were also impacted by reimbursements from our strategic partnerships.
Selling and Marketing (S&M) expenses in the first quarter of 2024 were $608 million, an increase of 11% compared to the first quarter of 2023 to support our Pivot to Growth strategy, mainly related to commercial activities for AUSTEDO and UZEDY in the U.S.
General and Administrative (G&A) expenses in the first quarter of 2024 were $278 million, a decrease of 6% compared to the first quarter of 2023, mainly due to lower litigation fees in the first quarter of 2024.
Operating loss in the first quarter of 2024 was $218 million, compared to an operating loss of $13 million in the first quarter of 2023. Operating loss as a percentage of revenues was 5.7% in the first quarter of 2024, compared to an operating loss as a percentage of revenues of 0.4% in the first quarter of 2023. The higher operating loss in the first quarter of 2024 was mainly due to higher other assets impairments, restructuring costs and other items, as well as higher S&M expenses in the first quarter of 2024, partially offset by higher gross profit, lower legal settlements and loss contingencies and lower intangible asset impairments in the first quarter of 2024. Non-GAAP operating income in the first quarter of 2024 was $892 million representing a non-GAAP operating margin of 23.4% compared to non-GAAP operating income of $785 million representing a non-GAAP operating margin of 21.4% in the first quarter of 2023. The increase in non-GAAP operating margin in the first quarter of 2024 was mainly impacted by an increase in non-GAAP gross profit margin, partially offset by higher S&M expenses as a percentage of revenues.
Financial expenses, net in the first quarter of 2024 were $250 million, mainly comprised of net-interest expenses of $233 million. In the first quarter of 2023, financial expenses, net were $260 million, mainly comprised of net-interest expenses of $236 million.
In the first quarter of 2024, we recognized a tax benefit of $52 million, on a pre-tax loss of $467 million. In the first quarter of 2023, we recognized a tax benefit of $19 million, on a pre-tax loss of $272 million. Our tax rate for the first quarter of 2024 was mainly affected by deferred tax benefits resulting from Intellectual Property ( IP )- related integration plans. Such integration plans have been adopted, among others, in an effort of addressing the global adoption of the Organization for Economic Co-operation and Development (OECD) Pillar Two minimum effective corporate tax, commencing in 2024.
Tax rate in the first quarter of 2024 was 11.1%, compared to 7.1% in the first quarter of 2023. Our tax rate for the first quarter of 2024 was mainly affected by deferred tax benefits resulting from intellectual property related integration plans. Non-GAAP tax rate in the first quarter of 2024 was 15.0%, compared to 15.5% in the first quarter of 2023. Our non-GAAP tax rate in the first quarter of 2024 was mainly affected by deferred tax benefits resulting from IP-related integration plans, the generation of profits in various jurisdictions with different tax rates, tax benefits in Israel and other countries, as well as infrequent or non-recurring items. Our non-GAAP tax rate in the first quarter of 2023 was mainly affected by the geographic mix of earnings and interest expense disallowances.
We expect our annual non-GAAP tax rate for 2024 to be between 14%-17%, higher than our non-GAAP tax rate for 2023, which was 13%, mainly due to a reduced net tax benefit related to deferred tax resulting from IP-related integration plans in 2024 compared to 2023.
Net loss attributable to Teva and loss per share in the first quarter of 2024 were $139 million and $0.12, respectively, compared to net loss attributable to Teva and loss per share of $220 million and $0.20, respectively, in the first quarter of 2023. The lower net loss in the first quarter of 2024 was mainly due to higher net loss attributable to non-controlling interests, higher gross profit and lower legal settlements and loss contingencies, partially offset by higher other asset impairments, restructuring and other items, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the first quarter of 2024 were $548 million and $0.48, respectively, compared to $457 million and $0.40, respectively, in the first quarter of 2023.
Net loss attributable to non-controlling interests was $280 million in the first quarter of 2024, compared to a net loss attributable to non-controlling interests of $33 million in the first quarter of 2023. The higher net loss in the first quarter of 2024 was mainly due to higher impairments of tangible assets largely related to the classification of a business in our International Markets segment as held for sale.
Adjusted EBITDA was $1,005 million in the first quarter of 2024, an increase of 12% compared to $899 million in the first quarter of 2023.
As of March 31, 2024 and 2023, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,167 million and 1,158 million, respectively.
Non-GAAP information : net non-GAAP adjustments in the first quarter of 2024 were $688 million. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS for the first quarter of 2024 were adjusted to exclude the following items:
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 used in operating activities during the first quarter of 2024 was $124 million, compared to $145 million of cash flow used in operating activities in the first quarter of 2023. The lower cash flow used in operating activities in the first quarter of 2024 resulted mainly from higher profit in our Europe segment, partially offset by changes in certain working capital items, including a negative impact from accounts payables.
During the first quarter of 2024, we generated free cash flow of $32 million, which we define as comprising $124 million in cash flow used in operating activities, $295 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program), partially offset by $124 million in cash used for capital investment and $15 million in cash used for acquisition of businesses, net of cash acquired. During the first quarter of 2023, we generated free cash flow of $41 million, which we define as comprising $145 million in cash flow used in operating activities, $323 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $2 million in proceeds from divestitures of businesses and other assets, partially offset by $139 million in cash used for capital investment.
As of March 31, 2024, our debt was $19,643 million, compared to $19,833 million as of December 31, 2023. This decrease was mainly due to $193 million of exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2024 was 16% compared to 8% as of December 31, 2023. Our average debt maturity was approximately 5.7 years as of March 31, 2024, compared to 6.0 years as of December 31, 2023.
On May 3, 2024, the terms of our revolving credit facility ( RCF ) were amended to update the Company s maximum permitted leverage ratio under the RCF for certain periods. Under the terms of the RCF, as amended, the Company s leverage ratio shall not exceed (i) 4.00x in 2024, 2025 and in the first quarter of 2026, (ii) 3.75x in the second, third and fourth quarters of 2026, and (iii) 3.50x in the first quarter of 2027 and onwards. The RCF permits the Company to increase the maximum leverage ratio if it consummates or commences certain material transactions.
Segment Results for the first 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 and the segment previously known as our North America segment is now referred to as our United States 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 March 31, 2024 and 2023:
| Three months ended March 31, | ||||||||||||||||
| 2024 | 2023 | |||||||||||||||
| (U.S. $ in millions /% of Segment Revenues) | ||||||||||||||||
| Revenues | $ | 1,725 | 100 | % | $ | 1,677 | 100 | % | ||||||||
| Gross profit | 858 | 49.8 | % | 789 | 47.0 | % | ||||||||||
| R&D expenses | 154 | 8.9 | % | 149 | 8.9 | % | ||||||||||
| S&M expenses | 261 | 15.1 | % | 207 | 12.4 | % | ||||||||||
| G&A expenses | 93 | 5.4 | % | 95 | 5.7 | % | ||||||||||
| Other income | 1 | |||||||||||||||
| Segment profit* | $ | 350 | 20.3 | % | $ | 338 | 20.2 | % |
Revenues from our United States segment in the first quarter of 2024 were $1,725 million, an increase of $48 million, or 3%, compared to the first quarter of 2023. This increase was mainly due to higher revenues from AUSTEDO, and higher revenues from generic products, partially offset by lower revenues from certain innovative products, primarily COPAXONE and BENDEKA and TREANDA , as well as from Anda, our distribution business.
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 March 31, 2024 and 2023:
| Three months ended March 31, | Percentage Change 2024-2023 | |||||||||||
| 2024 | 2023 | |||||||||||
| Generic products | $ | 808 | $ | 747 | 8 | % | ||||||
| AJOVY | 45 | 46 | (3 | %) | ||||||||
| AUSTEDO | 282 | 170 | 67 | % | ||||||||
| BENDEKA and TREANDA | 46 | 62 | (26 | %) | ||||||||
| COPAXONE | 30 | 71 | (58 | %) | ||||||||
| Anda | 381 | 424 | (10 | %) | ||||||||
| Other* | 133 | 158 | (16 | %) | ||||||||
| Total | $ | 1,725 | $ | 1,677 | 3 | % |
Generic products revenues in our United States segment (including biosimilars) in the first quarter of 2024 were $808 million, an increase of 8% compared to the first quarter of 2023, mainly due to revenues from lenalidomide capsules (the generic version of Revlimid ), partially offset by increased competition to other generic products.
In the first quarter of 2024, our total prescriptions were approximately 314 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions, compared to approximately 312 million (based on trailing twelve months), representing 8.3% of total U.S. generic prescriptions in the first quarter of 2023, all according to IQVIA data.
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 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 6 years and older. In June 2023, Alvotech and Teva reached a settlement and license agreement with Johnson & Johnson, granting a licensed entry date in the U.S. no later than February 21, 2025.
AJOVY revenues in our United States segment in the first quarter of 2024 were $45 million, flat compared to the first quarter of 2023. In the first quarter of 2024, AJOVY s exit market share in the United States in terms of total number of prescriptions was 27.4% compared to 24.5% in the first quarter of 2023.
AUSTEDO revenues in our United States segment in the first quarter of 2024 increased by 67%, to $282 million, compared to $170 million in the first quarter of 2023, mainly due to growth in volume including the launch of AUSTEDO XR in May 2023, as well as expanded access for patients and increased investment to support higher demand.
AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023, and became commercially available in the U.S. in May 2023. AUSTEDO XR is a new once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington s disease, additional to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by ten Orange Book patents expiring between 2031 and 2041.
UZEDY (risperidone) extended-release injectable suspension 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 nine Orange Book patents expiring between 2025 and 2033. We are moving forward with plans to launch UZEDY in other countries around the world.
BENDEKA and TREANDA combined revenues in our United States segment in the first quarter of 2024 decreased by 26% to $46 million, compared to the first quarter of 2023, mainly due to generic bendamustine products entry 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 first quarter of 2024 decreased by 58% to $30 million, compared to the first quarter of 2023, mainly due to generic competition and a decrease in glatiramer acetate market share due to availability of alternative therapies. COPAXONE revenues in the first quarter of 2024 were also negatively impacted by an increase in sales allowance due to a non-recurring item.
Anda revenues from third-party products in our United States segment in the first quarter of 2024 decreased by 10% to $381 million, compared to $424 million in the first quarter of 2023, mainly due to lower demand from seasonal and other market conditions. 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. 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 first quarter of 2024 was $858 million, an increase of 9% compared to $789 million in the first quarter of 2023.
Gross profit margin for our United States segment in the first quarter of 2024 increased to 49.8%, compared to 47.0% in the first quarter of 2023. This increase was mainly due to a favorable mix of products primarily driven by an increase in revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid ), as well as a decrease in our operational costs.
United States Profit
Profit from our United States 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.
Profit from our United States segment in the first quarter of 2024 was $350 million, an increase of 4% compared to $338 million in the first quarter of 2023. This increase was mainly due to higher gross profit, partially offset by higher S&M expenses.
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 March 31, 2024 and 2023:
| Three months ended March 31, | ||||||||||||||||
| 2024 | 2023 | |||||||||||||||
| (U.S. $ in millions / % of Segment Revenues) | ||||||||||||||||
| Revenues | $ | 1,272 | 100 | % | $ | 1,184 | 100 | % | ||||||||
| Gross profit | 738 | 58.0 | % | 655 | 55.3 | % | ||||||||||
| R&D expenses | 56 | 4.4 | % | 53 | 4.5 | % | ||||||||||
| S&M expenses | 194 | 15.2 | % | 187 | 15.8 | % | ||||||||||
| G&A expenses | 65 | 5.1 | % | 70 | 5.9 | % | ||||||||||
| Other income | 1 | |||||||||||||||
| Segment profit* | $ | 423 | 33.2 | % | $ | 345 | 29.1 | % |
Revenues from our Europe segment in the first quarter of 2024 were $1,272 million, an increase of 7%, or $88 million, compared to the first quarter of 2023. In local currency terms, revenues increased by 4% compared to the first quarter of 2023, mainly due to higher revenues from generic products and AJOVY.
In the first quarter of 2024, revenues from our Europe segment were positively impacted by exchange rate fluctuations of $43 million, including hedging effects, compared to the first quarter of 2023. Revenues in the first quarter of 2024 included $8 million from a positive hedging impact, which is included in Other in the table below. Revenues in the first quarter of 2023 included $6 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 March 31, 2024 and 2023:
| Three months ended March 31, | Percentage Change 2024-2023 | |||||||||||
| 2024 | 2023 | |||||||||||
| (U.S. $ in millions) | ||||||||||||
| Generic products | $ | 1,004 | $ | 932 | 8 | % | ||||||
| AJOVY | 51 | 36 | 42 | % | ||||||||
| COPAXONE | 57 | 59 | (4 | %) | ||||||||
| Respiratory products | 66 | 68 | (3 | %) | ||||||||
| Other | 94 | 89 | 6 | % | ||||||||
| Total | $ | 1,272 | $ | 1,184 | 7 | % |
Generic products revenues (including OTC and biosimilar products) in our Europe segment in the first quarter of 2024, were $1,004 million, an increase of 8% compared to the first quarter of 2023. In local currency terms, revenues increased by 5%, mainly due to higher volumes.
AJOVY revenues in our Europe segment in the first quarter of 2024 increased by 42% to $51 million, compared to $36 million in the first quarter of 2023. In local currency terms revenues increased by 40%, mainly due to growth in European countries in which AJOVY had previously been launched.
COPAXONE revenues in our Europe segment in the first quarter of 2024 decreased by 4% to $57 million, compared to the first quarter of 2023. In local currency terms, revenues decreased by 5%, due to price reductions and a decline in volume resulting from competing glatiramer acetate products and availability of alternative therapies.
Respiratory products revenues in our Europe segment in the first quarter of 2024 decreased by 3% to $66 million compared to the first quarter of 2023. In local currency terms, revenues decreased by 5% compared to the first quarter of 2023, mainly due to net price reductions and lower volumes.
Europe Gross Profit
Gross profit from our Europe segment in the first quarter of 2024 was $738 million, an increase of 13% compared to $655 million in the first quarter of 2023.
Gross profit margin for our Europe segment in the first quarter of 2024 increased to 58.0%, compared to 55.3% in the first quarter of 2023. This increase was mainly due to a favorable mix of products as well as a decrease in our operational costs.
Profit from 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.
Profit from our Europe segment in the first quarter of 2024 was $423 million, an increase of 22%, compared to $345 million in the first quarter of 2023. This increase was mainly due to higher gross profit, as described above.
International Markets Segment