BIOGEN INC
For the period ended Sep 30, 2024. Filed Oct 30, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Oct 30, 2024
BIIB$248.35+1.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-01.
0000875045-24-000025
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-10-30.
0000875045-24-000032
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 329 previous paragraphs and 369 current paragraphs.
202 unchanged; 82 reworded; 73 added; 37 removed; 8 previous and 12 current paragraphs rearranged.
Tables are not compared: 13 previous and 13 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (73)
Current report
ADVERSE WEATHER EVENTS
Current report
Adverse weather conditions, including hurricane, earthquake and natural disaster damage, may affect our ability to do business.
Current report
We currently have operations in RTP, North Carolina, which were not impacted by recent hurricanes.
Current report
GLOBAL SUPPLY CHAIN DISRUPTIONS
Current report
Global supply chain disruptions, such as strikes, work stoppages, port congestion, port closures and other logistical problems, may affect our ability to do business. For example, recent major port strikes on the East and Gulf Coasts of the U.S. resulted in delayed cargo movement for several days, with the potential for future port strikes as further contract negotiations are expected in January 2025.
Current report
As our primary shipping method for resources and finished goods is through air freight, the recent port strikes did not impact our business, however, we will continue to assess any future port disruptions and if necessary, secure alternative transportation.
Current report
$64.5 million or 2.5%
Current report
Increased
Current report
$3.13 or 666.0%
Current report
PRODUCT REVENUE, NET
Current report
$35.8 million or 2.0%
Current report
•MS revenue decreased $105.1 million, or 9.1%
Current report
•Rare disease revenue increased $44.9 million, or 10.0%
Current report
•U.S. product revenue for ZURZUVAE was $22.0 million during the third quarter of 2024.
Current report
$656.7 million or 24.6%
Current report
•Cost of sales decreased $20.9 million, or 3.2%
Current report
•SG&A expense decreased $199.8 million, or 25.3%
Current report
•Amortization and impairment of acquired intangible assets increased $69.4 million, or 114.0%
Current report
•The decrease in SG&A expense was primarily due to cost-reduction measures realized in 2024 in connection with our Fit for Growth program and approximately $196.4 million of equity-based compensation expense recognized in 2023 related to the acquisition of Reata.
Current report
•The increase in amortization and impairment of acquired intangible assets was primarily due toamortization for the Reata acquisition acquired intangible assets associated with SKYCLARYS, as well as impairment charges of $20.2 million related to commercialization rights terminated during the third quarter of 2024.
Current report
Under the terms of this acquisition, we paid shareholders of HI-Bio approximately $1.15 billion, at closing and may pay up to an additional$650.0 million in potential future development and regulatory milestone payments. We funded this acquisition through available cash on hand and accounted for this acquisition as a business combination using the acquisition method of accounting in accordance with ASC Topic 805, Business Combinations, and recorded assets acquired and liabilities assumed at their respective fair values as of the acquisition date.
Current report
•In October 2024 the Therapeutic Goods Administration of Australia issued a public statement about the initial decision not to register lecanemab. Eisai will request a reconsideration of this decision.
Current report
•In August 2024 LEQEMBI was approved by the Medicines and Healthcare products Regulatory Agency in Great Britain and by the Ministry of Health and Prevention in the United Arab Emirates.
Current report
FELZARTAMAB
Current report
In October 2024 the FDA granted felzartamab Breakthrough Therapy Designation for the treatment of late AMR without T-cell mediated rejection in kidney transplant patients.
Current report
UCB
Current report
In September 2024 we and UCB announced positive topline data from the Phase 3 PHOENYCS GO study of dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in people living with moderate-to-severe SLE. The Phase 3 study met the primary endpoint demonstrating clinical improvement in moderate-to-severe SLE with clinical improvements observed among key secondary endpoints. Based on these results, UCB and Biogen will be initiating a second Phase 3 study in 2024.
Current report
SPINRAZA (nusinersen)
Current report
In September 2024 we announced positive topline data from the Phase 2/3 DEVOTE study of nusinersen, which evaluated the safety and efficacy of a higher dose regimen of nusinersen in treatment-naive symptomatic infants with SMA. Based on this data we will plan to submit for regulatory approval.
Current report
SAGE COLLABORATION
Current report
In October 2024 we and Sage agreed to not pursue further development of zuranolone for the potential treatment of MDD. This decision was based on the significant new investment and time we expect would be needed to conduct the additional studies required to support approval of this indication. For additional information on our collaboration with Sage, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Current report
SAMSUNG BIOEPIS 2019 DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Current report
In October 2024 we notified Samsung Bioepis of our decision to terminate our 2019 Development and Commercialization Agreement (the DCA Agreement) solely within the U.S. and Canada. Biogen will transfer commercialization rights for BYOOVIZ and OPUVIZ in the U.S. and Canada back to Samsung Bioepis over a period of up to 18 months. During this transition period, we will continue to commercialize BYOOVIZ. The termination does not impact the other markets in the DCA Agreement. For additional information on our 2019 Development and Commercialization Agreement with Samsung Bioepis, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Current report
nm Not meaningful
Current report
•Global TYSABRI revenue decreased $50.2 million, from $456.3 million in 2023 to $406.1 million in 2024, or 11.0%, primarily due to increased competition, unfavorable channel dynamics in the U.S. and a decrease in pricing in certain international markets.
Current report
•Global VUMERITY revenue decreased $7.4 million, from $165.5 million in 2023 to $158.1 million in 2024, or 4.5%, primarily due to unfavorable channel dynamics in the U.S., partially offset by an increase in demand in rest of world VUMERITY.
Current report
•Rest of world SPINRAZA revenue decreased $69.4 million, from $297.7 million in 2023 to $228.3 million in 2024, or 23.3%, driven by the loss of an annual tender in Russia which resulted in an unfavorable impact of approximately $45.0 million. The decrease was also impacted by the timing of shipments and the unfavorable impact of foreign currency exchange.
Current report
•Rest of world SPINRAZA revenue decreased $182.7 million, from $875.6 million in 2023 to $692.9 million in 2024, or 20.9%, driven by the loss of an annual tender in Russia which resulted in an unfavorable impact of approximately $45.0 million. The decrease was also impacted by the timing of shipments and the unfavorable impact of foreign currency exchange.
Current report
nm Not meaningful
Current report
PRODUCT COST OF SALES
Showing the first 40 of 73 passages. Open the source sections for the rest.
Removed paragraphs (37)
Previous report
$8.9 million or 0.4%
Previous report
Decreased
Previous report
$0.07 or 1.7%
Previous report
$53.8 million or 2.9%
Previous report
•MS revenue decreased $59.5 million, or 4.9%
Previous report
•Rare disease revenue increased $96.1 million, or 21.9%
Previous report
$18.3 million or 1.0%
Previous report
•Cost of sales decreased $46.7 million, or 7.9%
Previous report
•SG&A expense increased $5.8 million, or 1.1%
Previous report
•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 report
•In April 2024 we received $437.5 million from Samsung BioLogics related to the sale of our equity interest in Samsung Bioepis.
Previous report
Under the terms of this acquisition, we made an upfront payment to HI-Bio of approximately $1.15 billion which was funded through available cash on hand. Additionally, we may pay up to $650.0 million in potential milestone payments to the former shareholders of HI-Bio. We expect this transaction to be accounted for as an acquisition of a business and recognized within our condensed consolidated financial statements during the third quarter of 2024.
Previous report
QALSODY (tofersen)
Previous report
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 report
SKYCLARYS (omaveloxolone)
Previous report
In February 2024 the EC approved SKYCLARYS in the E.U. for the treatment of FA in adults and adolescents aged 16 years and older. SKYCLARYS is the first treatment approved within the E.U. for this rare, genetic, progressive neurodegenerative disease.
Previous report
TOFIDENCE (referencing ACTEMRA)
Previous report
In June 2024 the EC approved TOFIDENCE, a biosimilar monoclonal antibody referencing ROACTEMRA. The IV formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
Previous report
PRODUCT REVENUE
Previous report
•Global TYSABRI revenue decreased $20.9 million, from $483.1 million in 2023 to $462.2 million in 2024, or 4.3%, primarily due to a decrease in U.S. TYSABRI revenue driven by increased competition, as well as a decrease in pricing in rest of world TYSABRI, partially offset by favorable channel dynamics in certain emerging markets.
Previous report
•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 report
•Rest of world SPINRAZA revenue decreased $9.5 million, from $281.3 million in 2023 to $271.8 million in 2024, or 3.4%, primarily due to the unfavorable impact of foreign currency exchange and the timing of shipments, offset in part by an increase in pricing.
Previous report
•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 report
•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 report
•discontinuation of BIIB093 for the treatment of TBI.
Previous report
•discontinuation of BIIB093 for large hemispheric infarction; and
Previous report
•discontinuation of BIIB093 for the treatment of TBI; and
Previous report
•discontinuation of BIIB135 for the treatment of MS.
Previous report
•discontinuation of BIIB093 for large hemispheric infarction; and
Previous report
•decreased spend in LEQEMBI due to the timing of clinical spend.
Previous report
For the three months ended June 30, 2024, compared to the same period in 2023, selling, general and administrative expense increased by approximately 1.1% 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 report
For the three months ended June 30, 2024, general and administrative expense increased by approximately $3.6 million, or 2.2%, compared to the same period in 2023, due to integration and other acquisition-related expenses. For the six months ended June 30, 2024, general and administrative expense decreased by approximately $5.2 million, or 1.6%, compared to the same period in 2023, due to cost-reduction measures. Excluding exit-related costs and acquisition-related expenses incurred during the three and six months ended June 30, 2024, general and administrative expense decreased by approximately $1.9 million, or 1.2%, and $21.3 million, or 6.5%, respectively.
Previous report
•The net unrealized losses recognized during the three months ended June 30, 2024, primarily reflect a decrease in the aggregate fair value of our investments in Sage and Sangamo common stock of approximately $51.4 million, partially offset by an increase in the fair value of Denali common stock of approximately $27.0 million.
Previous report
•The net unrealized losses recognized during the six months ended June 30, 2024, primarily reflect a decrease in the aggregate fair value of our investments in Sage and Sangamo common stock of approximately $68.3 million, partially offset by an increase in the fair value of Denali common stock of approximately $17.6 million.
Previous report
For the three and six months ended June 30, 2024, compared to the same periods in 2023, the changes in our effective tax rate include the impact of changes in jurisdictional profit mix, including non-cash tax effects of changes in the value of our equity investments.
Previous report
•$150.0 million decrease in current portion of debt due to the repayment of our 2023 Term Loan.
Previous report
For the six months ended June 30, 2024, compared to the same period in 2023, the change in net cash flow in investing activities was primarily due to the receipt of $437.5 million from Samsung BioLogics related to the sale of our 49.9% equity interest in Samsung Bioepis, the receipt of $103.0 million from the sale of one of our two PRV's and lower net purchases of marketable securities in 2024.
Reworded paragraphs (82)
Previous wording
The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements (condensed consolidated financial statements) and the accompanying notes beginning on page 8 of this quarterly report on Form 10-Q and our audited consolidated financial statements and the accompanying notes included in our 2023 Form 10-K. The results of operations of Reata, along with the estimated fair values of the assets acquired and liabilities assumed in the Reata acquisition, have been included in our condensed consolidated financial statements since the closing of the Reata acquisition on September 26, 2023.
Current wording
The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements (condensed consolidated financial statements) and the accompanying notes beginning on page 8 of this quarterly report on Form 10-Q and our audited consolidated financial statements and the accompanying notes included in our 2023 Form 10-K.
Previous wording
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of PPD and we have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
Current wording
We also have collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of PPD. We have certain business and financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, CLL and other conditions; RITUXAN HYCELA for the treatment of non-Hodgkin's lymphoma and CLL; GAZYVA for the treatment of CLL and follicular lymphoma; OCREVUS for the treatment of PPMS and RMS; LUNSUMIO for the treatment of relapsed or refractory follicular lymphoma; COLUMVI, a bispecific antibody for the treatment of non-Hodgkin's lymphoma; and have the option to add other potential anti-CD20 therapies, pursuant to our collaboration arrangements with Genentech, a wholly-owned member of the Roche Group.
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, 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.
Current wording
We commercialize a portfolio of biosimilars of advanced biologics including BENEPALI, an etanercept biosimilar referencing ENBREL; IMRALDI, an adalimumab biosimilar referencing HUMIRA; FLIXABI, an infliximab biosimilar referencing REMICADE; and BYOOVIZ, a ranibizumab biosimilar referencing LUCENTIS, in certain international markets, as well as 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, 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.
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 SWISSMEDIC and was placed into service. The second manufacturing suite, which was also licensed to operate by SWISSMEDIC, became operational in the first quarter of 2024. Solothurn has been approved for the manufacture of LEQEMBI. 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
Multiple TECFIDERA generic entrants are now in North America, Brazil and certain E.U. countries and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline in the future.
Current wording
Multiple TECFIDERA generic entrants are now in North America, Brazil and certain European countries and have deeply discounted prices compared to TECFIDERA. The generic competition for TECFIDERA has significantly reduced our TECFIDERA revenue and we expect that TECFIDERA revenue will continue to decline in the future.
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 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.
Current wording
Following a favorable decision of the CJEU affirming TECFIDERA's right to regulatory data and marketing protection, the EC determined that TECFIDERA is entitled to an additional year of market protection, which extends through February 2, 2025. Our entitlement to this additional year of market protection is being challenged. As of September 30, 2024, some of the TECFIDERA generics have not yet fully exited some European markets. We are closely monitoring this situation and seeking to enforce our legal right to market protection. In addition, are continuing to defend and seek to enforce our EP 2 653 873 patent related to TECFIDERA, which expires in 2028.
Previous wording
Economic conditions remain vulnerable as markets continue to be impacted in part by elevated inflation, higher interest rates, global supply chain uncertainties and risks associated with geopolitical conflicts.
Current wording
Economic conditions remain vulnerable as markets continue to be impacted in part by elevated inflation, higher interest rates, extreme weather events, global supply chain uncertainties and risks associated with geopolitical conflicts.
Previous wording
Global disputes and interruptions in international relationships, including tariffs, trade protection measures, import or export licensing requirements and the imposition of trade sanctions or similar restrictions by the U.S. or other governments, affect our ability to do business. For example, tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China mainland, as well as other business restrictions, with additional restrictive measures being proposed.
Current wording
Global disputes and interruptions in international relationships, including tariffs, trade protection measures, import or export licensing requirements and the imposition of trade sanctions or similar restrictions by the U.S. or other governments, affect our ability to do business. For example, tensions between China and Taiwan and tensions between the U.S. and China have led to a series of tariffs and sanctions being imposed by the U.S. on imports from China mainland, as well as other business restrictions, with additional restrictive measures being proposed.
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 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.
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 nine months ended September 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 nine months ended September 30, 2024 and 2023.
Previous 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.
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, unfavorable channel dynamics in the U.S. and a decrease in pricing in certain international markets.
Previous 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.
Current wording
•The increase in rare disease product revenue was primarily due to global SKYCLARYS revenue of $102.3 million in the third quarter of 2024, partially offset by a decrease in rest of world SPINRAZA revenue driven by the loss of an annual tender in Russia which resulted in an unfavorable impact of approximately $45.0 million. The decrease was also impacted by the timing of SPINRAZA shipments and the unfavorable impact of foreign currency exchange.
Previous wording
•R&D expense decreased $70.3 million, or 12.0%
Current wording
•R&D expense decreased $193.6 million, or 26.3%
Previous wording
•The decrease in cost of sales was primarily due to favorable product mix from decreased contract manufacturing revenue and lower idle capacity charges, offset in part by $44.1 million in amortization costs associated with the acquired SKYCLARYS inventory fair value step-up adjustment.
Current wording
•The decrease in cost of sales was primarily due to favorable product mix from decreased contract manufacturing revenue and lower idle capacity charges.
Previous 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.
Current wording
•The decrease in R&D expense was primarily driven by approximately $197.0 million of equity-based compensation expense recognized in 2023 related to the Reata acquisition, 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 $42.5 million of equity-based compensation expense recognized in 2024 related to the HI-Bio acquisition.
Previous 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.
Current wording
•Cash and cash equivalents totaled approximately $1.7 billion as of September 30, 2024, compared to approximately $1.0 billion as of December 31, 2023.
Previous wording
•We generated $1,179.0 million of net cash flow from operations for the six months ended June 30, 2024.
Current wording
•We generated approximately $2.1 billion of net cash flow from operations for the nine months ended September 30, 2024.
Previous wording
On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases. HI-Bio's lead asset, felzartamab, an anti-CD38 antibody currently being evaluated for three leading indications, aMR, PMN and IgAN. Felzartamab has received Breakthrough Therapy Designation and Orphan Drug Designation from the FDA for development in the treatment of PMN and has received ODD in the treatment of antibody-mediated rejection in kidney transplant recipients. The acquisition of HI-Bio is expected to augment our pipeline and build on our expertise in immunology.
Current wording
On July 2, 2024, we completed the acquisition of all of the issued and outstanding shares of HI-Bio, a privately-held clinical-stage biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases. HI-Bio's lead asset, felzartamab, an anti-CD38 antibody, is currently being evaluated for three leading indications, Antibody-Mediated Rejection (AMR), Primary Membranous Nephropathy (PMN) and Immunoglobulin A Nephropathy (IgAN). Felzartamab has received Breakthrough Therapy Designation and ODD from the FDA for development in the treatment of PMN and AMR and has received ODD in the treatment of antibody-mediated rejection in kidney transplant recipients. The acquisition of HI-Bio is expected to augment our pipeline and build on our expertise in immunology.
Previous wording
In addition to lead program felzartamab, the HI-Bio pipeline acquired includes izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase 1 trial, and the potential for continued development in a range of complement-mediated diseases.
Current wording
In addition to the lead program felzartamab, the HI-Bio pipeline acquired includes izastobart/HIB210, an anti-C5aR1 antibody currently in a Phase 1 trial, and the potential for continued development in a range of complement-mediated diseases. For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report.
Previous 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.
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 was paid 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 nine months ended September 30, 2024. For additional information on the sale of our PRV, please read Note 3, Dispositions, to our condensed consolidated financial statements included in this report.
Previous wording
In July 2024 we and Sage announced that the Phase 2 KINETIC 2 dose-range study of BIIB124, for the potential treatment in essential tremor, did not meet its endpoints. Based on these results, we discontinued our further development of BIIB124 for the potential treatment in essential tremor. We and Sage are evaluating next steps, if any, for other potential indications.
Current wording
In July 2024 we and Sage announced that the Phase 2 KINETIC 2 dose-range study of BIIB124 did not meet its endpoints. Based on these results, we discontinued our further development of BIIB124.
Previous 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.
Current wording
•Global TECFIDERA revenue decreased $6.7 million, from $239.5 million in 2023 to $232.8 million in 2024, or 2.8%, 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 Interferon revenue decreased $51.5 million, from $302.4 million in 2023 to $250.9 million in 2024, or 17.0%, driven by a decrease in demand as patients transition to higher efficacy therapies.
Current wording
•Global Interferon revenue decreased $40.2 million, from $277.7 million in 2023 to $237.5 million in 2024, or 14.5%, driven by a decrease in demand as patients transition to higher efficacy therapies.
Previous 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.
Current wording
•Global TYSABRI revenue decreased $112.6 million, from $1,412.2 million in 2023 to $1,299.6 million in 2024, or 8.0%, primarily due to a decrease in U.S. TYSABRI revenue driven by increased competition, unfavorable channel dynamics and higher discounts and allowances, as well as a decrease in pricing in rest of world TYSABRI.
Previous wording
•Global TECFIDERA revenue decreased $22.2 million, from $528.7 million in 2023 to $506.5 million in 2024, or 4.2%, 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 $28.9 million, from $768.2 million in 2023 to $739.3 million in 2024, or 3.8%, 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 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.
Current wording
•Global Interferon revenue decreased $93.7 million, from $825.7 million in 2023 to $732.0 million in 2024, or 11.3%, driven by a decrease in demand as patients transition to higher efficacy therapies.
Previous wording
•Global VUMERITY revenue increased $38.9 million, from $254.4 million in 2023 to $293.3 million in 2024, or 15.3%, primarily due to primarily due to an increase in global demand, favorable channel dynamics and an increase in pricing.
Current wording
•Global VUMERITY revenue increased $31.5 million, from $419.9 million in 2023 to $451.4 million in 2024, or 7.5%, primarily due to an increase in global demand and favorable channel dynamics.
Previous wording
•U.S. SPINRAZA revenue increased $3.3 million, from $302.5 million in 2023 to $305.8 million in 2024, or 1.1%, primarily due to favorable net pricing, offset by a decrease in demand.
Current wording
•U.S. SPINRAZA revenue increased $2.6 million, from $150.5 million in 2023 to $153.1 million in 2024, or 1.7%, primarily due to favorable net pricing, offset in part by unfavorable channel dynamics and a decrease in demand.
Previous 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.
Current wording
•Global SKYCLARYS revenue was $102.3 million in 2024, including $81.8 million of U.S. SKYCLARYS revenue, which we began recognizing during the fourth quarter of 2023, subsequent to our acquisition of Reata, and $20.5 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
•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.
Current wording
•U.S. SPINRAZA revenue increased $5.9 million, from $453.0 million in 2023 to $458.9 million in 2024, or 1.3%, primarily due to favorable net pricing, offset by a decrease in demand.
Previous wording
•Global SKYCLARYS revenue was $178.0 million in 2024, including $148.6 million of U.S. SKYCLARYS revenue, which we began recognizing during the fourth quarter of 2023, subsequent to our acquisition of Reata, and $29.4 million of rest of world SKYCLARYS revenue, which was approved in the E.U. and became commercially available during the first quarter of 2024.
Current wording
•Global SKYCLARYS revenue was $280.3 million in 2024, including $230.4 million of U.S. SKYCLARYS revenue, which we began recognizing during the fourth quarter of 2023, subsequent to our acquisition of Reata, and $49.9 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
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.
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 high-single digits.
Previous wording
•For the three months ended June 30, 2024, compared to the same period of 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., partially offset by a decrease in pricing due to competitive pressures.
Current wording
•For the three and nine months ended September 30, 2024, compared to the same periods of 2023, the increases in biosimilar revenue were primarily due to increases in sales volumes related to BENEPALI, offset by decreases in pricing due to competitive pressures.
Previous 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.
Current wording
For the three and nine months ended September 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 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.
Current wording
For the three and nine months ended September 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 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.
Current wording
For the three and nine months ended September 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
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.
Current wording
For the three and nine months ended September 30, 2024, reserves for discounts and allowances as a percentage of gross product revenue were 32.6% and 32.4%, respectively, compared to 31.7% in both prior year comparative periods.
Previous wording
For the three months ended June 30, 2024, compared to the same period in 2023, the decrease in contractual adjustments was primarily due to lower government rebates in rest of world.
Current wording
For the three months ended September 30, 2024, compared to the same period in 2023, the decrease in contractual adjustments was primarily due to lower Medicaid rebates, partially offset by higher government rebates in the U.S.
Previous 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.
Current wording
For the nine months ended September 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 and lower Medicaid rebates in the U.S.
Previous 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.
Current wording
For the three months ended September 30, 2024, compared to the same period in 2023, the increase in discounts was primarily driven by higher purchase discounts in rest of world and the U.S.
Previous 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.
Current wording
For the three and nine months ended September 30, 2024, compared to the same periods in 2023, the decreases in returns were primarily driven by lower returns in the U.S.
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Rearranged current paragraphs (12)
Current report — wording carried from elsewhere
The results of operations of Reata and HI-Bio, along with the estimated fair values of the assets acquired and liabilities assumed in the acquisitions, have been included in our condensed consolidated financial statements since the closing of the Reata and HI-Bio acquisitions on September 26, 2023 and July 2, 2024, respectively.
Current report — wording carried from elsewhere
On July 2, 2024, we completed the acquisition of HI-Bio. As a result of this transaction we acquired HI-Bio's lead asset, felzartamab, an anti-CD38 antibody currently being evaluated for three leading indications, AMR, PMN and IgAN. For additional information on our acquisition of HI-Bio, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report.
Current report — wording carried from elsewhere
For the nine months ended September 30, 2024, compared to the same period in 2023, the increase in discounts was primarily driven by higher purchase and volume discounts for biosimilars.
Current report — wording carried from elsewhere
•advancement of BIIB059 for the treatment of CLE into late stage; and
Current report — wording carried from elsewhere
•advancement of QALSODY from late stage to marketed upon the accelerated approval of QALSODY in the U.S.;
Current report — wording carried from elsewhere
The decrease in marketed programs was driven by a decrease in costs associated with:
Current report — wording carried from elsewhere
For the nine months ended September 30, 2023, selling, general and administrative expense also included a $31.0 million obligation to Eisai related to the termination of the co-promotion agreement for our MS products in Japan during the first quarter of 2023 and accelerated depreciation recognized during the second quarter of 2023 of approximately $11.5 million.
Current report — wording carried from elsewhere
Additionally, following the close of our HI-Bio acquisition in July 2024, we implemented an integration plan designed to realize operating synergies through cost savings and avoidance. Under this initiative, we incurred approximately $1.5 million of severance and employment costs, which are reflected in restructuring charges within our condensed consolidated statements of income for the three and nine months ended September 30, 2024.
Current report — wording carried from elsewhere
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report.
Current report — wording carried from elsewhere
$350.0 million of the 364--day tranche. The remaining $150.0 million portion of the 364-day tranche was repaid during the first quarter of 2024.
Current report — wording carried from elsewhere
In August 2024 we entered into a $1.5 billion, five-year senior unsecured revolving credit facility under which we are permitted to draw funds for working capital and general corporate purposes. The terms of the revolving credit facility include a financial covenant that requires us not to exceed a maximum consolidated leverage ratio. This revolving credit facility replaced the revolving credit facility entered into in January 2020, as discussed below.
Current report — wording carried from elsewhere
As of September 30, 2024 and December 31, 2023, we had no outstanding borrowings and were in compliance with all covenants under both facilities.
Rearranged previous paragraphs (8)
Previous report — wording carried elsewhere
•We received a cash payment of $103.0 million from the sale of one of our two PRV's during the second quarter of 2024, of which we recognized a net portion of approximately $88.6 million.
Previous report — wording carried elsewhere
•development of cemdomespib for the treatment of diabetic neuropathic pain; and
Previous report — wording carried elsewhere
The decrease in late stage programs was driven by a decrease in costs associated with:
Previous report — wording carried elsewhere
•advancement of ZURZUVAE from late stage to marketed upon the approval of ZURZUVAE for PPD in the U.S.;
Previous report — wording carried elsewhere
•advancement of BIIB059 for the treatment of CLE into late stage.
Previous report — wording carried elsewhere
•advancement of ZURZUVAE from late stage to marketed upon the approval of ZURZUVAE for PPD in the U.S.
Previous report — wording carried elsewhere
For additional information on our acquisition of Reata, please read Note 2, Acquisitions, to our condensed consolidated financial statements included in this report. For additional information on our collaboration arrangements with Eisai, please read Note 19, Collaborative and Other Relationships, to our condensed consolidated financial statements included in this report.
Previous report — wording carried elsewhere
In July 2024 we completed the acquisition of all of the issued and outstanding shares of HI-Bio for $1.15 billion, which was funded through available cash on hand.