BIOGEN INC

Previous wording

Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases worldwide. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA, co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a genetic cause of ALS. Through our 2023 acquisition of Reata we market the first and only drug approved in the U.S. and the E.U. for the treatment of Friedreich's Ataxia in adults and adolescents aged 16 years and older. We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases. We support our drug discovery and development efforts through internal research and development programs and external collaborations.

Current wording

Biogen is a global biopharmaceutical company focused on discovering, developing and delivering innovative therapies for people living with serious and complex diseases worldwide. We have a broad portfolio of medicines to treat MS, have introduced the first approved treatment for SMA, co-developed treatments to address a defining pathology of Alzheimer’s disease and launched the first approved treatment to target a genetic cause of ALS. Through our 2023 acquisition of Reata we market the first and only drug approved in the U.S. and the E.U. for the treatment of Friedreich's Ataxia in adults and adolescents aged 16 years and older. We are focused on advancing our pipeline in neurology, specialized immunology and rare diseases. We support our drug discovery and development efforts through internal research and development programs, external collaborations and acquisitions.

Previous wording

We commercialize a portfolio of biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in the U.S. and certain international markets. We also have exclusive rights to commercialize TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA. We continue to develop potential biosimilar product SB15, a proposed aflibercept biosimilar referencing EYLEA. We continue to evaluate strategic options for our biosimilars business.

Current wording

We commercialize a portfolio of biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL, IMRALDI, an adalimumab biosimilar referencing HUMIRA, and FLIXABI, an infliximab biosimilar referencing REMICADE, in certain countries in Europe, as well as BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, and TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, in the U.S. and certain international markets. We also have commercialization rights related to OPUVIZ, an aflibercept biosimilar referencing EYLEA.

Previous wording

We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we continually review our manufacturing capacity, capabilities, processes and facilities. In order to support our future growth and drug development pipeline, we expanded our large molecule production capacity and built a large-scale biologics manufacturing facility in Solothurn, Switzerland. In the second quarter of 2021 a portion of this facility (the first manufacturing suite) received a GMP multi-product license from the SWISSMEDIC and was placed into service. The second manufacturing suite became operational in the first quarter of 2024. Solothurn has been approved for the manufacture of LEQEMBI by the FDA. We believe that the Solothurn facility will support our anticipated near to mid-term needs for the manufacturing of biologic assets. The plant represents a significant increase in our overall manufacturing capacity and is not yet being fully utilized, resulting in our recording of excess capacity charges. If we are unable to fully utilize our manufacturing facilities, we will incur additional excess capacity charges which would have a negative effect on our financial condition and results of operations.

Current wording

We seek to ensure an uninterrupted supply of medicines to patients around the world. To that end, we continually review our manufacturing capacity, capabilities, processes and facilities. In order to support our future growth and drug development pipeline, we expanded our large molecule production capacity and built a large-scale biologics manufacturing facility in Solothurn, Switzerland. In the second quarter of 2021 a portion of this facility (the first manufacturing suite) received a GMP multi-product license from the SWISSMEDIC and was placed into service. The second manufacturing suite, which was also licensed to operate by the SWISSMEDIC, became operational in the first quarter of 2024. Solothurn has been approved for the manufacture of LEQEMBI by the FDA. We believe that the Solothurn facility will support our anticipated near to mid-term needs for the manufacturing of biologic assets. The plant represents a significant increase in our overall manufacturing capacity and is not yet being fully utilized, resulting in our recording of excess capacity charges. If we are unable to fully utilize our manufacturing facilities, we will incur additional excess capacity charges which would have a negative effect on our financial condition and results of operations.

Previous wording

Following a favorable March 2023 decision of the CJEU affirming TECFIDERA's right to regulatory data and marketing protection and the EC determination in May 2023 that TECFIDERA is entitled to an additional year of market protection for its pediatric indication, we believe that TECFIDERA is entitled to regulatory marketing protection in the E.U. until at least February 2, 2025, and are seeking to enforce this protection. As of March 31, 2024, some of the TECFIDERA generics have not yet fully exited some E.U. markets. We are closely monitoring this situation and working to enforce our legal right to market protection. In addition, we will continue to enforce our EP 2 653 873 patent related to TECFIDERA, which expires in 2028.

Current wording

Following a favorable March 2023 decision of the CJEU affirming TECFIDERA's right to regulatory data and marketing protection and the EC determination in May 2023 that TECFIDERA is entitled to an additional year of market protection for its pediatric indication, we believe that TECFIDERA is entitled to regulatory marketing protection in the E.U. until at least February 2, 2025, and are seeking to enforce this protection. As of June 30, 2024, some of the TECFIDERA generics have not yet fully exited some E.U. markets. We are closely monitoring this situation and working to enforce our legal right to market protection. In addition, we will continue to defend and enforce our EP 2 653 873 patent related to TECFIDERA, which expires in 2028.

Previous wording

We, and the pharmaceutical industry, utilize China-based partners for certain raw materials, ingredients and components for our pharmaceutical products and their delivery devices. Engaging alternative suppliers may involve seeking additional regulatory approvals and be costly in terms of time and resources needed. For example, certain early processes related to our newly acquired SKYCLARYS product rely on a single supplier based in China. We are continuing to evaluate SKYCLARYS' supply chain and prioritizing actions to mitigate risks associated with its manufacturing and our ability to supply patients.

Current wording

We, and the pharmaceutical industry, utilize China-based partners for certain raw materials, ingredients and components for our pharmaceutical products and their delivery devices. Engaging alternative suppliers may involve seeking additional regulatory approvals and be costly in terms of time and resources needed. For example, certain early processes related to our acquired SKYCLARYS product rely on a single supplier based in China. We are continuing to evaluate SKYCLARYS' supply chain and prioritizing actions to mitigate risks associated with its manufacturing and our ability to supply patients.

Previous wording

The ongoing geopolitical tensions related to Russia's invasion of Ukraine and the recent military conflict in the Middle East have resulted in global business disruptions and economic volatility.

Current wording

The ongoing geopolitical tensions related to Russia's invasion of Ukraine and the military conflict in the Middle East have resulted in global business disruptions and economic volatility.

Previous wording

We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations. Revenue generated from sales in Russia and Ukraine represent less than 2.0% of total revenue for the three months ended March 31, 2024 and 2023. Additionally, revenue generated from sales in the broader Middle East region represents less than 2.0% of total revenue for the three months ended March 31, 2024 and 2023.

Current wording

We will continue to monitor the ongoing conflict between Russia and Ukraine as well as the military conflict in the Middle East and assess any potential impacts on our business, supply chain, partners or customers, as well as any factors that could have an adverse effect on our results of operations. Revenue generated from sales in Russia and Ukraine represent less than 2.0% of total revenue for the three and six months ended June 30, 2024 and 2023. Additionally, revenue generated from sales in the broader Middle East region represents less than 2.0% of total revenue for the three and six months ended June 30, 2024 and 2023.

Previous wording

In March 2024 the SEC adopted final rules designed to enhance disclosures related to the impacts of climate-related matters. The final rules require disclosures of material climate-related risks, activities to mitigate or adapt to such risks, information about our board of directors' oversight of climate-related risks and management’s role in managing material climate-related risks and information on any climate-related targets or goals that are material to our business, results of operations or financial condition. In addition, the E.U. and California have enacted similar legislation and regulations. We are currently evaluating the potential impact that these new rules and laws will have on our business.

Current wording

In March 2024 the SEC adopted final rules designed to enhance disclosures related to the impacts of climate-related matters. The final rules require disclosures of material climate-related risks, activities to mitigate or adapt to such risks, information about our board of directors' oversight of climate-related risks and management’s role in managing material climate-related risks and information on any climate-related targets or goals that are material to our business, results of operations or financial condition. In addition, the E.U. and California have enacted similar legislation and regulations. The E.U.'s Corporate Sustainability Reporting Directive will require expansive disclosures on various ESG matters for companies whose business and assets exceed certain thresholds within E.U. countries. California's new environmental disclosure laws will impose additional climate-related reporting requirements on large companies conducting business in the state of California.

Previous wording

•The decrease in MS product revenue was primarily due to a decrease in TECFIDERA demand as a result of multiple TECFIDERA generic entrants in North America, Brazil and certain E.U. countries, a decrease in Interferon demand due to competition as patients transition to higher efficacy therapies and a decrease in U.S. TYSABRI revenue primarily driven by increased competition and higher discounts and allowances.

Current wording

•The decrease in MS product revenue was primarily due to a decrease in Interferon demand due to competition as patients transition to higher efficacy therapies and a decrease in global TYSABRI revenue driven by increased competition in the U.S., as well as a decrease in pricing in certain international markets.

Previous wording

•The decrease in rare disease revenue was due to a decrease in rest of world SPINRAZA revenue resulting primarily from the timing of shipments, which we expect to largely normalize throughout the remainder of 2024. Rest of world patient numbers have generally remained stable through the first quarter of 2024. We also saw a modest negative impact from increased competition and the unfavorable impact of foreign currency exchange. The decrease was partially offset by global SKYCLARYS revenue of $78.0 million in the first quarter of 2024.

Current wording

•The increase in rare disease revenue was due to global SKYCLARYS revenue of $100.0 million in the second quarter of 2024. The increase was partially offset by a decrease in rest of world SPINRAZA revenue resulting primarily from the unfavorable impact of foreign currency exchange and the timing of shipments, offset in part by an increase in pricing.

Previous wording

•R&D expense decreased $117.7 million, or 20.6%

Current wording

•R&D expense decreased $70.3 million, or 12.0%

Previous wording

•The decrease in research and development expense was primarily driven by cost-reduction measures realized in 2024 in connection with our Fit for Growth program and clinical trial close out costs incurred in 2023 related to ADUHELM.

Current wording

•The decrease in research and development expense was primarily driven by cost-reduction measures realized in 2024 in connection with our portfolio prioritization initiatives and our Fit for Growth program, as well as higher spend on clinical trials and close out costs incurred during 2023, partially offset by approximately $46.0 million of step-up amortization related to SKYCLARYS inventory.

Previous wording

•The decrease in selling, general and administrative expense was primarily due to cost-reduction measures realized in 2024 in connection with our Fit for Growth program, offset by an increase in operational spending on sales and marketing activities in support of LEQEMBI and SKYCLARYS as we continue to expand our U.S. and international product launches.

Current wording

•The increase in selling, general and administrative expense was primarily due to an increase in operational spending on sales and marketing activities in support of LEQEMBI and SKYCLARYS as we continue to expand our U.S. and international product launches, offset in part by cost-reduction measures realized in 2024 in connection with our Fit for Growth program.

Previous wording

•Cash, cash equivalents and marketable securities totaled approximately $1.1 billion as of March 31, 2024, compared to approximately $1.0 billion as of December 31, 2023.

Current wording

•Cash and cash equivalents totaled approximately $1.9 billion as of June 30, 2024, compared to approximately $1.0 billion as of December 31, 2023.

Previous wording

•We generated $553.2 million of net cash flow from operations for the three months ended March 31, 2024.

Current wording

•We generated $1,179.0 million of net cash flow from operations for the six months ended June 30, 2024.

Previous wording

On April 24, 2024, we entered into a definitive agreement with a third party to sell a rare pediatric disease priority review voucher. In consideration for the PRV we received $103.0 million upon the closing of the PRV purchase.

Current wording

In April 2024 we completed the sale of our rare pediatric disease PRV, generated by the development associated with SPINRAZA, to a third party. In consideration for the PRV we received a cash payment of $103.0 million upon the closing of the PRV purchase, of which approximately $14.4 million is payable to Ionis. Our net portion of approximately $88.6 million was recognized in gain on sale of priority review voucher, net within our condensed consolidated statements of income for the three and six months ended June 30, 2024.

Previous wording

•In March 2024 Eisai completed the submission of LEQEMBI supplemental BLA for monthly IV maintenance dosing for the treatment of early Alzheimer's disease to the FDA.

Current wording

•In June 2024 the FDA accepted for review the supplemental BLA for LEQEMBI monthly IV maintenance dosing for the treatment of early Alzheimer's disease, with a PDUFA action date set for January 25, 2025.

Previous wording

In February 2024 we announced the CHMP of the EMA adopted a positive opinion recommending a MAA under exceptional circumstances for tofersen, for the treatment of adults with ALS associated with a mutation in the SOD1 gene. If authorized by the EC, tofersen will be the first treatment approved in the E.U. to target a genetic cause of ALS.

Current wording

In May 2024 the EC approved QALSODY in the E.U. for the treatment of adults with ALS associated with a mutation in the SOD1 gene and became the first treatment approved in the E.U. to target a genetic cause of ALS.

Previous wording

In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025. As a result of this termination, Acorda will regain global commercialization rights to FAMPYRA. On April 1, 2024, Acorda filed for bankruptcy protection and announced its intention to sell substantially all its assets to a third party. We are evaluating the impact of these developments on the transition process for the FAMPYRA rights.

Current wording

In January 2024 we notified Acorda of our decision to terminate our collaboration and license agreement, effective January 1, 2025. As a result of this termination, Acorda will regain global commercialization rights to FAMPYRA. On April 1, 2024, Acorda filed for bankruptcy protection and announced its intention to sell substantially all its assets to a third party. On July 10, 2024, Merz Therapeutics announced that it had completed the acquisition of FAMPYRA, and related assets from Acorda. We are now working with Merz Therapeutics on the transition of global commercialization rights of FAMPYRA.

Previous wording

•Global TECFIDERA revenue decreased $20.2 million, from $274.5 million in 2023 to $254.3 million in 2024, or 7.4%, driven by a decrease in demand as a result of multiple TECFIDERA generic entrants in North America, Brazil and certain E.U. countries.

Current wording

•Global TECFIDERA revenue decreased $2.0 million, from $254.2 million in 2023 to $252.2 million in 2024, or 0.8%, driven by a decrease in demand as a result of multiple TECFIDERA generic entrants in North America, Brazil and certain E.U. countries.

Previous wording

•Global VUMERITY revenue increased $19.3 million, from $108.2 million in 2023 to $127.5 million in 2024, or 17.8%, primarily due to an increase in global demand and favorable channel dynamics and an increase in pricing in U.S. VUMERITY.

Current wording

•Global VUMERITY revenue increased $19.6 million, from $146.2 million in 2023 to $165.8 million in 2024, or 13.4%, primarily due to an increase in global demand, favorable channel dynamics and an increase in pricing in rest of world VUMERITY.

Previous wording

•Global TYSABRI revenue decreased $41.5 million, from $472.8 million in 2023 to $431.3 million in 2024, or 8.8%, primarily due to a decrease in U.S. TYSABRI revenue driven by increased competition and higher discounts and allowances.

Current wording

•Global TYSABRI revenue decreased $62.4 million, from $955.9 million in 2023 to $893.5 million in 2024, or 6.5%, primarily due to a decrease in U.S. TYSABRI revenue driven by increased competition and higher discounts and allowances, as well as a decrease in pricing in rest of world TYSABRI, partially offset by favorable channel dynamics in certain emerging markets.

Previous wording

•Global Interferon revenue decreased $2.0 million, from $245.6 million in 2023 to $243.6 million in 2024, or 0.8%, driven by a decrease in demand as patients transition to higher efficacy therapies, partially offset by an favorable channel dynamics in U.S. Interferons.

Current wording

•Global Interferon revenue decreased $53.5 million, from $548.0 million in 2023 to $494.5 million in 2024, or 9.8%, driven by driven by a decrease in demand as patients transition to higher efficacy therapies.

Previous wording

In 2024 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the U.S. and rest of world markets. We are also aware of a biosimilar entrant of TYSABRI that was approved in the U.S. in August 2023 and the E.U. in September 2023. We believe that future sales of TYSABRI may be adversely affected by the entrance of this biosimilar.

Current wording

In 2024 we expect total MS revenue will continue to decline as a result of increasing competition for many of our MS products in both the U.S. and rest of world markets. Additionally, a biosimilar entrant of TYSABRI was approved in the U.S. and the E.U. in 2023. We believe that future sales of TYSABRI may be adversely affected by the entrance of this biosimilar.

Previous wording

•U.S. SPINRAZA revenue increased $1.8 million, from $146.7 million in 2023 to $148.5 million in 2024, or 1.2%, primarily due to favorable net pricing.

Current wording

•U.S. SPINRAZA revenue increased $1.5 million, from $155.8 million in 2023 to $157.3 million in 2024, or 1.0%, primarily due to favorable net pricing, offset by a decrease in demand.

Previous wording

•Global SKYCLARYS revenue was $78.0 million in 2024, including $73.0 million of U.S. SKYCLARYS revenue, which we began recognizing during the fourth quarter of 2023 subsequent to our acquisition of Reata, and $5.0 million of rest of world SKYCLARYS revenue, which was approved in the E.U. and became commercially available during the first quarter of 2024.

Current wording

•Global SKYCLARYS revenue was $100.0 million in 2024, including $75.6 million of U.S. SKYCLARYS revenue, which we began recognizing during the fourth quarter of 2023, subsequent to our acquisition of Reata, and $24.4 million of rest of world SKYCLARYS revenue, which was approved in the E.U. and became commercially available during the first quarter of 2024.

Previous wording

•Rest of world SPINRAZA revenue decreased $103.8 million, from $296.6 million in 2023 to $192.8 million in 2024, or 35.0%. The majority of this year-over-year decline was due to the timing of shipments, which we expect to largely normalize throughout the remainder of 2024. Rest of world patient numbers have generally remained stable through the first quarter of 2024. We also saw a modest negative impact from increased competition and the unfavorable impact of foreign currency exchange.

Current wording

•Rest of world SPINRAZA revenue decreased $113.3 million, from $577.9 million in 2023 to $464.6 million in 2024, or 19.6%, primarily due to the timing of shipments, which we expect to largely normalize throughout the remainder of 2024. Rest of world patient numbers have generally remained stable through the second quarter of 2024. We also saw a modest negative impact from increased competition and the unfavorable impact of foreign currency exchange.

Previous wording

In 2024 we expect growth in rare disease revenue as we continue to launch SKYCLARYS in the U.S. We expect global SPINRAZA revenue to decrease by low single digits.

Current wording

In 2024 we expect growth in rare disease revenue as we continue to launch SKYCLARYS in the U.S. and E.U. We expect global SPINRAZA revenue to decrease by low single digits.

Previous wording

•For the three months ended March 31, 2024, compared to the same period of 2023, the increase in biosimilar revenue was primarily due to channel dynamics, offset in part by a decrease in pricing due to competitive pressures.

Current wording

•For the six months ended June 30, 2024, compared to the same period in 2023, the increase in biosimilar revenue was primarily due to an increase in sales volumes related to the continued growth of BYOOVIZ in the U.S. and channel dynamics, offset in part by a decrease in pricing due to competitive pressures.

Previous wording

Biosimilars revenue includes sales from BENEPALI, IMRALDI, FLIXABI and BYOOVIZ. In 2023 BYOOVIZ became commercially available in certain international markets. During the third quarter of 2023 the FDA approved TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, which we expect to become commercially available during 2024.

Current wording

Biosimilars revenue includes sales from BENEPALI, IMRALDI, FLIXABI, BYOOVIZ and TOFIDENCE. In 2023 BYOOVIZ became commercially available in certain international markets. During the third quarter of 2023 the FDA approved TOFIDENCE, a tocilizumab biosimilar referencing ACTEMRA, which became commercially available in the U.S. during the second quarter of 2024. TOFIDENCE was also approved in the E.U. during the second quarter of 2024.

Previous wording

In 2024 we anticipate modest growth in revenue from our biosimilars business. We continue to work with our third-party contract manufacturers for IMRALDI and BENEPALI to address supply constraints. If not resolved these supply constraints could have an adverse impact on 2024 sales. In addition, one of our contract manufacturers for IMRALDI and BENEPALI entered into a proposed acquisition by a third party, which is expected to close at the end of 2024. We are currently evaluating the impact this will have on our biosimilars business and working to implement mitigation activities.

Current wording

We continue to work with our third-party contract manufacturers for IMRALDI and BENEPALI to address supply constraints. If not resolved these supply constraints could have an adverse impact on 2024 sales. In addition, one of our contract manufacturers for IMRALDI and BENEPALI entered into a proposed acquisition by a third party, which is expected to close at the end of 2024. We are currently evaluating the impact this will have on our biosimilars business and working to implement mitigation activities.

Previous wording

For the three months ended March 31, 2024, compared to the same period in 2023, the increase in royalty revenue on sales of OCREVUS was primarily due to sales growth of OCREVUS in the U.S.

Current wording

For the three and six months ended June 30, 2024, compared to the same periods in 2023, the increases in royalty revenue on sales of OCREVUS were primarily due to sales growth of OCREVUS in the U.S.

Previous wording

For the three months ended March 31, 2024, compared to the same period in 2023, the decrease in our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO was primarily due to a decrease in sales of RITUXAN in the U.S. resulting from competition from multiple biosimilar products.

Current wording

For the three and six months ended June 30, 2024, compared to the same periods in 2023, the decreases in our share of pre-tax profits in the U.S. for RITUXAN, GAZYVA and LUNSUMIO were primarily due to decreases in sales of RITUXAN in the U.S. resulting from competition from multiple biosimilar products, partially offset by increases in sales of GAZYVA.

Previous wording

For the three months ended March 31, 2024, compared to the same period in 2023, the decrease in contract manufacturing revenue was primarily driven by higher volumes in 2023 due to the timing of batch production, which includes batches related to LEQEMBI that we began recognizing in the first quarter of 2023 upon the accelerated approval of LEQEMBI in the U.S.

Current wording

For the three and six months ended June 30, 2024, compared to the same periods in 2023, the decreases in contract manufacturing revenue were primarily driven by higher volumes in 2023 due to the timing of batch production, which includes batches related to LEQEMBI that we began recognizing in the first quarter of 2023 upon the accelerated approval of LEQEMBI in the U.S.

Previous wording

Royalty and other revenue primarily reflects the royalties we receive from net sales on products related to patents that we have out-licensed, as well as royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal.

Current wording

Royalty and other revenue primarily reflects royalty revenue on biosimilar products from our license arrangements with Samsung Bioepis and our 50.0% share of LEQEMBI product revenue, net and cost of sales, including royalties, as we are not the principal, as well as royalties we receive from net sales on products related to patents that we have out-licensed.

Previous wording

For the three months ended March 31, 2024, reserves for discounts and allowances as a percentage of gross product revenue was 33.2% compared to 31.4% in the prior year comparative period.

Current wording

For the three and six months ended June 30, 2024, reserves for discounts and allowances as a percentage of gross product revenue were 31.6% and 32.4%, respectively, compared to 32.1% and 31.8%, respectively, in the prior year comparative periods.

Previous wording

For the three months ended March 31, 2024, compared to the same period in 2023, the increase in contractual adjustments was primarily due to higher Medicaid and government rebates in the U.S., partially offset by lower government rebatesin rest of world.

Current wording

For the six months ended June 30, 2024, compared to the same period in 2023, the increase in contractual adjustments was primarily due to higher government rebates in the U.S. and higher other rebates in biosimilars, partially offset by lower government rebates in rest of world.

Previous wording

Discounts include trade term discounts and wholesaler incentives.

Current wording

Discounts include trade term discounts, wholesaler incentives and volume related discounts.

Previous wording

For the three months ended March 31, 2024, compared to the same period in 2023, the increase in discounts was primarily driven by higher purchase and volume discounts for biosimilars.

Current wording

For the three and six months ended June 30, 2024, compared to the same periods in 2023, the increases in discounts were primarily driven by higher purchase and volume discounts for biosimilars, partially offset by lower purchase discounts in rest of world.

Previous wording

For the three months ended March 31, 2024, compared to the same period in 2023, the increase in returns was primarily driven by higher return rates in the U.S.

Current wording

For the three and six months ended June 30, 2024, compared to the same periods in 2023, the increases in returns were primarily driven by higher return rates in the U.S.