On October 30, 2024 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the third quarter ended September 30, 2024 and provided a corporate update (Press release, Intra-Cellular Therapies, OCT 30, 2024, View Source [SID1234647541]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by CAPLYTA’s strong growth trajectory in the third quarter and look forward to further growth in the remainder of 2024 and beyond. We are on track to submit our sNDA for the adjunctive treatment of MDD later this year and our commercial team is actively preparing for a potential launch in 2025," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

Third Quarter Financial Highlights

•
Total revenues were $175.4 million for the third quarter of 2024, compared to $126.2 million for the same period in 2023. Net product sales of CAPLYTA were $175.2 million for the third quarter of 2024, compared to $125.8 million for the same period in 2023.

•
Net loss for the third quarter of 2024 was $26.3 million compared to a net loss of $24.3 million for the same period in 2023.

•
Cost of product sales was $15.3 million in the third quarter of 2024 compared to $9.1 million for the same period in 2023.

•
Selling, general and administrative (SG&A) expenses were $132.1 million for the third quarter of 2024, compared to $105.2 million for the same period in 2023.

•
Research and development (R&D) expenses were $66.8 million for the third quarter of 2024, compared to $41.6 million for the same period in 2023.

•
Cash, cash equivalents, investment securities, and restricted cash totaled $1.0 billion at September 30, 2024.

Commercial Update

•
CAPLYTA total prescriptions increased 38% in the third quarter of 2024, compared to the same period in 2023 and 9% in the third quarter of 2024, compared to the second quarter of 2024.

•
In the third quarter of 2024, we completed an expansion of our sales force, adding approximately 150 sales representatives to leverage the growing opportunity with primary care physicians in CAPLYTA’s current indications. A second primary care physician sales force expansion is planned for 2025 in connection with the potential approval of CAPLYTA for the adjunctive treatment of MDD.

Fiscal 2024 Financial Outlook

•
Raised CAPLYTA full year 2024 net product sales guidance range to $665 to $685 million.

•
Narrowed full year 2024 SG&A expense guidance range to $490 to $510 million and full year 2024 R&D expense guidance range to $220 to $230 million.

CLINICAL HIGHLIGHTS

Lumateperone:

•
Adjunctive MDD program: In the third quarter of 2024, we had a successful pre-sNDA meeting with the FDA for lumateperone for the adjunctive treatment of MDD. The positive and robust results from Phase 3 Studies 501 and 502 form the basis of our sNDA, which we anticipate submitting to the FDA in the fourth quarter of 2024.

Results from Study 501 were presented at the European College of Neuropsychopharmacology Congress in September. This week, we are presenting results from Studies 501 and 502 at the Psych Congress being held in Boston, MA. As previously disclosed, Studies 501 and 502 demonstrated robust efficacy of lumateperone added to an antidepressant for the treatment of MDD in the primary endpoint, the Montgomery Asberg Depression Rating Scale (MADRS) total score, with a large separation versus placebo of 4.9 points in Study 501 and 4.5 points in Study 502, and a robust effect size of 0.61 in Study 501 and 0.56 in Study 502. In both studies, symptom improvement occurred as

early as one week. Both studies also met the key secondary endpoint (CGI-S) and showed statistically significant efficacy in the patient self-reported measure of symptom severity of depression as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS). We will continue to share results from our Phase 3 MDD studies with the medical community at other upcoming conferences in 2024 and 2025.

•
Lumateperone bipolar mania program: Patient enrollment is ongoing in our two multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies evaluating lumateperone in adults in the acute treatment of manic or mixed episodes associated with bipolar I disorder (bipolar mania).

•
Lumateperone pediatric program: Patient enrollment is ongoing in our double-blind, placebo-controlled study in bipolar depression and in our open-label safety study in schizophrenia and bipolar disorder in pediatric patients. Patient enrollment in two Phase 3 studies in pediatric patients for the treatment of irritability associated with autism spectrum disorder is anticipated to commence in the fourth quarter of 2024.
•
Lumateperone long acting injectable (LAI) program: A Phase 1 single ascending dose study evaluating several formulations has commenced clinical conduct. The goal of the program is to develop LAI formulations that are effective, safe, and well-tolerated with treatment durations of one month or longer.

Other pipeline programs:

•
ITI-1284-ODT-SL program: Patient enrollment is ongoing in our Phase 2 clinical study evaluating ITI-1284 as adjunctive therapy to approved anti-anxiety medications in patients with GAD. A second Phase 2 GAD study, evaluating ITI-1284 as monotherapy, is expected to commence later this year.

In the third quarter of 2024, we commenced enrollment in a Phase 2 clinical study evaluating ITI-1284 in patients with psychosis associated with Alzheimer’s disease. In addition, we recently commenced patient enrollment in our Phase 2 program in agitation associated with Alzheimer’s disease.

•
Phosphodiesterase type I inhibitor (PDE1) program: Our portfolio of PDE1 inhibitors continues to advance in clinical development.

Lenrispodun (ITI-214) Parkinson’s disease (PD) program: Our lenrispodun Phase 2 clinical trial is evaluating improvements in motor symptoms, changes in cognition and inflammatory biomarkers in patients with PD. We anticipate completion of this study by the end of 2025.

ITI-1020 oncology program: Clinical conduct continues in our Phase 1 single ascending dose study in healthy volunteers evaluating the pharmacokinetics, safety, and tolerability of different doses of ITI-1020.

•
ITI-333 program: ITI-333, a 5-HT2A receptor antagonist and µ-opioid receptor partial agonist, provides potential utility in the treatment of opioid use disorder and pain. A multiple ascending dose study has been completed and a positron emission tomography (PET) study is ongoing.

•
ITI-1500 non-hallucinogenic neuroplastogen program: This program is focused on the development of novel neuroplastogens for the treatment of mood, anxiety, and other neuropsychiatric disorders without the hallucinogenic and cardiovascular effects of psychedelics. ITI-1549 is undergoing IND enabling studies and is expected to enter human testing in 2025.

Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. To attend the live conference call by phone, please use this registration link (https://register.vevent.com/register/BI1898608c75d549d2a97e359f537afbaa). All participants must use the link to complete the online registration process in advance of the conference call.

The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings:

•
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.

•
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.

Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

•
Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.

•
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.

•
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose.

TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.

•
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.

•
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.

•
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.

•
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.

•
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.

•
Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.

•
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.

•
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

On October 30, 2024 Eli Lilly and Company (NYSE: LLY) reported its financial results for the third quarter of 2024 (Press release, Eli Lilly, OCT 30, 2024, View Source [SID1234647540]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Lilly had another strong growth quarter in Q3, with total revenue increasing by 42% after excluding divestiture activity in the same period last year," said David A. Ricks, Lilly chair and CEO. "While the growth of Mounjaro and Zepbound is impressive, we are equally proud of the 17% growth in non-incretin revenue, which includes our oncology, immunology and neuroscience portfolios, compared with Q3 2023 on the same basis. The new product approvals for Ebglyss and Kisunla, exciting new pipeline data for tirzepatide, donanemab, imlunestrant and lebrikizumab, as well as key milestone achievements in our supply network, all point to the continued expansion of our impact on human health and significant growth of the company ahead."

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:
•U.S. Food and Drug Administration approval of Ebglyss, a first-line biologic for the treatment of adults and children 12 years of age or older with moderate-to-severe atopic dermatitis;
•Approval of Kisunla in Japan for the treatment of early symptomatic Alzheimer’s disease;
•Positive topline results from the SURMOUNT-1 176-week study of tirzepatide (Zepbound and Mounjaro) showing 94% reduction in the risk of developing type 2 diabetes in adults with pre-diabetes, and obesity or overweight;
•Positive six-month Phase 3 primary endpoint data from the TRAILBLAZER-ALZ 6 trial showing that modified titration achieved similar levels of amyloid plaque removal while also reducing the incidence of ARIA-E to 14%, compared with 24% in the standard dosing regimen;
•Positive Phase 3 EMBER-3 study evaluating imlunestrant oral SERD in patients with second-line ER+, HER2- metastatic breast cancer;
•Positive results from the ADjoin long-term extension study for Ebglyss showing sustained disease control for up to three years in more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to Ebglyss treatment;
•Launch of 2.5 mg and 5 mg single-dose Zepbound vials in the U.S. exclusively through LillyDirect to expand supply and increase access;
•Completion of the acquisition of Morphic Holding, Inc., expanding Lilly’s immunology pipeline;
•Expansion of the company’s manufacturing footprint in Ireland with a $1.8 billion investment in Limerick ($1 billion) and Kinsale ($800 million) to enhance global medicine production;

•Opening of the Lilly Seaport Innovation Center, a research and development facility which serves as the central hub for Lilly’s genetic medicines efforts;
•Announcement of $4.5 billion investment to develop the Lilly Medicine Foundry in Indiana, the first-ever facility to combine research and manufacturing in a single location to increase capacity for clinical trial medicines; and
•Appointment of Lucas Montarce as Lilly’s executive vice president and chief financial officer.

For information on important public announcements, visit the news section of Lilly’s website.

Financial Results
$ in millions, except
per share data
Third Quarter
2024 2023 % Change
Revenue $ 11,439.1 $ 9,498.6 20%
Net income (loss) – Reported 970.3 (57.4) NM
Earnings (loss) per share – Reported 1.07 (0.06) NM
Net income – Non-GAAP 1,064.5 94.8 NM
Earnings per share – Non-GAAP 1.18 0.10 NM
NM – not meaningful

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Third-Quarter Reported Results
In Q3 2024, worldwide revenue was $11.44 billion, an increase of 20% compared with Q3 2023, driven by a 15% increase in volume and a 6% increase due to higher realized prices, partially offset by a 1% decrease from the unfavorable impact of foreign exchange rates. The volume increase was primarily driven by growth from Mounjaro and Zepbound, partially offset by the sale of rights for the olanzapine portfolio (Zyprexa) in Q3 2023 and declines in Trulicity. Excluding revenue from the olanzapine portfolio, revenue in Q3 2024 increased 42%; worldwide volume increased 36%; and non-incretin revenue increased 17%. Higher realized prices were primarily driven by Trulicity, Humalog and Verzenio. New Products(i) revenue grew by $3.07 billion to $4.51 billion in Q3 2024, led by Mounjaro and Zepbound. Growth Products(ii) revenue increased 5% to $5.19 billion in Q3 2024 as growth led by Verzenio and Taltz was largely offset by lower Trulicity sales.

Revenue in the U.S. increased 46% to $7.81 billion, driven by a 35% increase in volume and an 11% increase in realized prices. The increase in U.S. volume was driven by Zepbound and Mounjaro, partially offset by declines in Trulicity. The higher realized prices in the U.S. were primarily driven by Trulicity, Humalog and Verzenio. Following higher wholesaler inventory levels at the end of Q2, Mounjaro and Zepbound sales in Q3 were negatively impacted by inventory decreases in the wholesaler channel. The company estimates this impacted Q3 sales of Mounjaro and Zepbound by mid-single digits as a percent of aggregate U.S. sales of these products.

Revenue outside the U.S. decreased 12% to $3.63 billion, driven by a 10% decrease in volume and a 1% decrease due to the unfavorable impact of foreign exchange rates, as realized prices remained relatively flat. The decrease in volume outside the U.S was driven by the sale of rights for the olanzapine portfolio in Q3 2023. Excluding the olanzapine portfolio, revenue and volume outside the U.S. increased 33% and 36%, respectively, primarily driven by Mounjaro and Verzenio.

Gross margin increased 21% to $9.27 billion in Q3 2024. Gross margin as a percent of revenue was 81.0%, an increase of 0.6 percentage points. The increase in gross margin percent was primarily driven by favorable product mix and higher realized prices, partially offset by the sale of rights for the olanzapine portfolio in Q3 2023 and higher manufacturing costs.

In Q3 2024, research and development expenses increased 13% to $2.73 billion, or 23.9% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 16% to $2.10 billion in Q3 2024, primarily driven by promotional efforts supporting ongoing and future launches.

In Q3 2024, the company recognized acquired in-process research and development (IPR&D) charges of $2.83 billion compared with $2.98 billion in Q3 2023. The Q3 2024 charges were primarily related to the acquisition of Morphic Holding, Inc. The Q3 2023 charges were primarily related to the acquisitions of DICE Therapeutics, Inc., Versanis Bio, Inc. and Emergence Therapeutics AG.

Asset impairment, restructuring and other special charges of $81.6 million in Q3 2024 were primarily related to impairment of an intangible asset associated with a molecule in development. There were no asset impairment, restructuring and other special charges in Q3 2023.

Other income (expense) was income of $62.0 million in Q3 2024, compared to expense of $23.2 million in Q3 2023. The higher income was primarily driven by net gains on investments in equity securities in Q3 2024, partially offset by higher interest expenses.

The effective tax rate was 38.9% in Q3 2024 compared with 113.4% in Q3 2023. The effective tax rates for Q3 2024 and Q3 2023 were both unfavorably impacted by non-deductible acquired IPR&D charges, with a larger impact occurring in Q3 2023.

In Q3 2024, net income and earnings per share (EPS) were $970.3 million and $1.07, respectively, compared with a net loss of $(57.4) million and loss per share of $(0.06) in Q3 2023. EPS in Q3 2024 included $3.08 of acquired IPR&D charges. EPS in Q3 2023 included $1.22 of EPS associated with the sale of rights for the olanzapine portfolio and $3.29 of acquired IPR&D charges.

Third-Quarter Non-GAAP Measures
On a non-GAAP basis, Q3 2024 gross margin increased 21% to $9.41 billion. Gross margin as a percent of revenue was 82.2%, an increase of 0.5 percentage points. The increase in gross margin
5

percent was primarily driven by favorable product mix and higher realized prices, partially offset by the sale of rights for the olanzapine portfolio in Q3 2023 and higher manufacturing costs.

The effective tax rate on a non-GAAP basis was 37.6% in Q3 2024 compared with 84.6% in Q3 2023. The effective tax rates for Q3 2024 and Q3 2023 were both unfavorably impacted by non-deductible acquired IPR&D charges, with a larger impact occurring in Q3 2023.

On a non-GAAP basis, Q3 2024 net income and EPS were $1.06 billion and $1.18, respectively, compared with net income of $94.8 million and EPS of $0.10 in Q3 2023. Non-GAAP EPS in Q3 2024 included $3.08 of acquired IPR&D charges. Non-GAAP EPS in Q3 2023 included $1.22 of EPS associated with the sale of rights for the olanzapine portfolio and $3.29 of acquired IPR&D charges.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Third Quarter
2024 2023 % Change
Earnings (loss) per share (reported) $ 1.07 $ (0.06) NM
Amortization of intangible assets .12 .11
Asset impairment, restructuring and other special charges .07 —
Net (gains) losses on investments in equity securities (.09) .06
Earnings per share (non-GAAP) $ 1.18 $ 0.10 NM
Acquired IPR&D 3.08 3.29 (6)%
Numbers may not add due to rounding
NM – not meaningful

6

Selected Revenue Highlights
(Dollars in millions)
Third Quarter
Year-to-Date
Selected Products 2024 2023 % Change 2024 2023 % Change
Mounjaro $ 3,112.7 $ 1,409.3 NM $ 8,010.0 $ 2,957.5 NM
Trulicity 1,301.4 1,673.6 (22)% 4,003.3 5,463.2 (27)%
Verzenio 1,369.3 1,040.2 32% 3,751.5 2,717.9 38%
Zepbound
1,257.8 — NM 3,018.4 — NM
Taltz
879.6 744.2 18% 2,308.4 1,975.0 17%
Jardiance(a)
686.4 700.8 (2)% 2,142.5 1,946.6 10%
Humalog(b)
534.6 395.4 35% 1,704.9 1,296.8 31%
Total Revenue 11,439.1 9,498.6 20% 31,509.9 24,770.7 27%

Mounjaro
For Q3 2024, worldwide Mounjaro revenue was $3.11 billion compared with $1.41 billion in Q3 2023. U.S. revenue was $2.38 billion compared with $1.28 billion in Q3 2023, reflecting continued strong demand, increased supply and, to a lesser extent, favorable changes to estimates for rebates and discounts. Q3 sales in the U.S. were negatively impacted by inventory decreases in the wholesaler channel. Revenue outside the U.S. increased to $728.0 million compared with $132.4 million in Q3 2023, primarily driven by volume associated with the launch of Mounjaro KwikPen in various markets.

Trulicity
For Q3 2024, worldwide Trulicity revenue decreased 22% to $1.30 billion. U.S. revenue decreased 26% to $935.3 million, driven by decreased sales volume primarily due to competitive dynamics, partially offset by higher realized prices primarily due to changes to estimates for rebates and discounts. Revenue outside the U.S. decreased 12% to $366.0 million, primarily driven by decreased volume due to competitive dynamics.

Verzenio
For Q3 2024, worldwide Verzenio revenue increased 32% to $1.37 billion. U.S. revenue was $878.8 million, an increase of 28%, primarily driven by increased demand and higher realized prices, partially offset by wholesaler buying patterns. Revenue outside the U.S. was $490.4 million, an increase of 38%, primarily driven by increased demand.

Zepbound
For Q3 2024, U.S. Zepbound revenue was $1.26 billion. Q3 sales in the U.S. were negatively impacted by inventory decreases in the wholesaler channel. Zepbound launched in the U.S. for the treatment of adult patients with obesity or overweight with weight-related comorbidities in November 2023.

Taltz
For Q3 2024, worldwide Taltz revenue increased 18% compared with Q3 2023 to $879.6 million. U.S. revenue increased 18% to $600.3 million, driven by higher realized prices and, to a lesser extent, increased demand, partially offset by wholesaler buying patterns. Revenue outside the U.S. increased 19% to $279.3 million, driven by increased demand.

Jardiance
For Q3 2024, the company’s worldwide Jardiance revenue decreased 2% compared with Q3 2023 to $686.4 million. U.S. revenue was $335.9 million, a decrease of 19%, driven by lower realized prices, partially offset by increased demand. Revenue outside the U.S. was $350.5 million, an increase of 23%, driven by increased volume.

Jardiance is part of the company’s alliance with Boehringer Ingelheim. Lilly reports as revenue royalties received on net sales of Jardiance.

Humalog
For Q3 2024, worldwide Humalog revenue increased 35% to $534.6 million. U.S. revenue was $323.9 million, an increase of 67%, driven by higher realized prices primarily due to segment mix. Revenue outside the U.S. was $210.8 million, an increase of 5%, driven by higher realized prices in China, partially offset by decreased volume and the unfavorable impact of foreign exchange rates.

2024 Financial Guidance
The company updated 2024 full-year revenue guidance to between $45.4 billion and $46.0 billion. The company is investing heavily in increasing the supply of tirzepatide and has been balancing demand creation activities and launches into new markets with its production to support the continuity of care for patients. In Q3, the company continued to be prudent in scaling up demand generation activities.

The ratio of (Gross Margin – OPEX) / Revenue, where OPEX is defined as the sum of research and development expenses and marketing, selling and administrative expenses, is still expected to be in the range of 36% to 38% on a reported basis and 37% to 39% on a non-GAAP basis.

Guidance now includes acquired IPR&D charges of $3.09 billion, or $3.33 on a per share basis. This reflects Q3 2024 charges of $2.83 billion, or $3.08 on a per share basis, primarily related to the acquisition of Morphic Holding, Inc.

Guidance on a reported basis now includes asset impairment, restructuring and other special charges of $517 million, reflecting the Q3 2024 charge of $82 million which was primarily related to impairment of an intangible asset associated with a molecule in development.

Other income (expense) is now expected to be in a range of ($425) to ($325) million of expense on a reported basis and is still expected to be in a range of ($400) to ($300) million of expense on a non-GAAP basis. The updated reported guidance reflects net gains on investments in equity securities in Q3 2024.

Tax rate guidance is now approximately 17% on both a reported and non-GAAP basis, driven by the impact of non-deductible acquired IPR&D charges in Q3 2024.

Based on these changes, EPS guidance has been lowered to the ranges of $12.05 to $12.55 on a reported basis and $13.02 to $13.52 on a non-GAAP basis. The company’s 2024 financial guidance reflects adjustments shown in the reconciliation table below.

On October 30, 2024 Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, reported its third quarter 2024 financial results and highlighted recent corporate achievements (Press release, Day One, OCT 30, 2024, View Source [SID1234647539]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our third quarter results demonstrate continued patient demand for OJEMDA, driven by the need for new therapies for children living with pediatric low-grade glioma," said Jeremy Bender, Ph.D., chief executive officer of Day One. "Looking ahead to 2025, we plan to continue to drive growth by advancing our programs and pipeline, including DAY301, a potential first-in-class ADC targeting PTK7 that we expect to be in the clinic in the coming months."

Program Highlights

•
Strong growth in OJEMDA net revenue with $20.1M in the third quarter of 2024, representing a 145% increase over the second quarter of 2024.

•
Quarterly prescriptions (TRx) grew to 619 in the third quarter of 2024, representing a 159% increase over the second quarter of 2024.

•
Day One expects to dose the first patient in the Phase 1a portion of the Phase 1a/b clinical trial of DAY301 by the end of 2024 or in the first quarter of 2025.

•
Day One provided updated duration of response data from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG. For the 77 patients enrolled on Arm 1, which was the dataset used to assess OJEMDA’s efficacy, the median duration of response is 18 months.

•
The pivotal Phase 3 FIREFLY-2/LOGGIC clinical trial evaluating tovorafenib as a front-line therapy in patients aged 6 months to 25 years with pLGG continues to enroll patients in the United States, Canada, Europe, Australia and Asia, with more than 100 sites activated.

Corporate Highlights and Upcoming Milestones

•
Day One and Ipsen entered into an exclusive licensing agreement to commercialize tovorafenib outside of the U.S. in July 2024. Under the agreement, Day One received approximately $111 million upfront in cash and equity investment at a premium with up to approximately $350 million in additional launch and sales milestone payments as well as tiered double-digit royalties starting at mid-teens percentage on net sales.

•
Day One entered into a definitive agreement for an oversubscribed private placement of its securities for total gross proceeds of approximately $175 million in July 2024.

Third Quarter 2024 Financial Highlights

•
Product Revenue, Net: OJEMDA net product revenues were $20.1 million for the third quarter of 2024, the first full quarter of the U.S. launch.

•
License Revenue: License revenue from the sale of ex-U.S. commercial rights for tovorafenib was $73.7 million for the third quarter of 2024.

•
R&D Expenses: Research and development expenses were $33.6 million for the third quarter of 2024 compared to $33.2 million for the third quarter of 2023. The increase was primarily due to the clinical trial activities related to tovorafenib and additional employee compensation costs.

•
SG&A Expenses: Selling, general and administrative expenses were $29.0 million for the third quarter of 2024 compared to $18.3 million for the third quarter of 2023. The increase was primarily due to employee compensation costs, commercial launch activities, and professional service expenses to support the launch of OJEMDA.

•
Net Income/Loss: Net income totaled $37.0 million for the third quarter of 2024 with non-cash stock-based compensation expense of $11.6 million, compared to a net loss of $46.2 million for the third quarter of 2023, with non-cash stock-based compensation expense of $9.6 million.

•
Cash Position: The Company’s cash, cash equivalents and short-term investments totaled $558.4 million as of September 30, 2024.

Upcoming Events

•
Two posters on health-related quality of life and drug holiday from the registrational Phase 2 FIREFLY-1 trial investigating tovorafenib in patients with BRAF-altered, relapsed or progressive pLGG will be presented at the Society for Neuro-Oncology Annual Meeting on November 22, 2024.

•
Piper Sandler 36th Annual Healthcare Conference, December 3-5, 2024.

Conference Call

Day One will host a conference call and webcast today, October 30 at 4:30 p.m. Eastern Time. To access the live conference call by phone, dial 877-704-4453 (domestic) or 201-389-0920 (international), and provide the access code 13745150. Live audio webcast will be accessible from the Day One Investors & Media page. To ensure a timely connection to the webcast, it is recommended that participants register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Day One Investors & Media page for 30 days following the event.

About OJEMDA

OJEMDA (tovorafenib) is a Type II RAF kinase inhibitor of mutant BRAF V600, wild-type BRAF, and wild-type CRAF kinases.

OJEMDA is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Tovorafenib was granted Breakthrough Therapy and Rare Pediatric Disease designations by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration, and it was evaluated by the FDA under priority review. Tovorafenib has also received Orphan Drug designation from the FDA for the treatment of malignant glioma and from the European Commission for the treatment of glioma.

For more information, please visit www.ojemda.com.

On October 30, 2024 Cerus Corporation (Nasdaq: CERS) reported financial results for its third quarter and nine months ended September 30, 2024 (Press release, Cerus, OCT 30, 2024, View Source [SID1234647535]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Total revenue for the three and nine months ended September 30, 2024 was comprised of ( in thousands, except %) :

Three Months Ended

Nine Months Ended

September 30,

Change

September 30,

Change

2024

2023

$

%

2024

2023

$

%

Product Revenue

$

46,017

$

39,772

$

6,245

16

%

$

129,461

$

109,599

$

19,862

18

%

Government Contract Revenue

4,639

7,479

(2,840

)

-38

%

15,109

23,856

(8,747

)

-37

%

Total Revenue

$

50,656

$

47,251

$

3,405

7

%

$

144,570

$

133,455

$

11,115

8

%

Recent highlights include:

Partnered with U.S. Biomedical Advanced Research and Development Authority (BARDA) for new, six-year contract with value up to $248 million designed to support advancement of INTERCEPT Blood System for Red Blood Cells (RBCs) beyond U.S. Phase 3 studies through potential PMA licensure and into commercialization.
CE Mark review for INTERCEPT RBCs concluded without approval; assessing strategy for potential future regulatory submission in collaboration with Notified Body, TÜV-SÜD.
Further expanded U.S. manufacturing capacity for INTERCEPT Fibrinogen Complex (IFC) following receipt of three additional biologics license application (BLA) approvals by Cerus IFC production partners.
Multiple presentations across the INTERCEPT product portfolio at this month’s 2024 Association for Advancement of Blood & Biotherapies (AABB) Annual Meeting, including real-world case studies for IFC and clinical data from the U.S. Phase 3 ReCePI trial.
Submitted CE Mark dossier for LED illuminator in Europe to TÜV-SÜD.
Narrowed GAAP net loss attributable to Cerus Corporation to $2.9 million and generated positive non-GAAP adjusted EBITDA of $4.4 million for the third quarter.
Generated positive operating cash flows for the third straight quarter of 2024 bringing year-to-date positive operating cash flows to $6.4 million.
"Our performance, both commercially and financially, was very strong for the third quarter," stated William "Obi" Greenman, Cerus’ president and chief executive officer. "In addition to the organic growth in our North American INTERCEPT platelet business, we are pleased to have secured meaningful additional U.S. manufacturing capacity for IFC with the new BLA approvals, which will allow us to address the growing demand for the product. As a result of our strong performance during the first three quarters coupled with our expectations for future growth in our business segments, we are raising our full year product revenue guidance and increasing the lower end of our IFC guidance. Beyond the top-line, we have also delivered on our bottom-line and cashflow targets for Q3. We believe we are on track to hit our full-year 2024 goals as the year wraps up."

"With respect to our development pipeline, we are pleased to have submitted our LED illuminator regulatory filing in Europe in the third quarter," continued Greenman. "This much-anticipated new technology platform will enable operational improvements alongside the dependability that our customers have grown to expect from the INTERCEPT System. As we reported earlier this month, our RBC program remains a key focus for us in both the U.S., with the new BARDA contract accelerating a number of initiatives, as well as in the EU, where we anticipate an enhanced regulatory submission that we expect will incorporate the ReCePI Phase 3 clinical data."

Revenue

Product revenue during the third quarter of 2024 was $46.0 million, compared to $39.8 million during the prior year period. This year-over-year increase of 16% was driven primarily by growth in the Company’s platelets business, particularly in North America. Third-quarter product revenue included sales of IFC, which were $2.3 million, up from $1.7 million during the prior year period.

Third-quarter 2024 government contract revenue was $4.6 million, compared to $7.5 million during the prior year period. The Company’s government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT Blood System for RBCs as well as efforts related to the development of next-generation pathogen reduction technology to treat whole blood and development of a lyophilized IFC. Reported government contract revenue during the third quarter of 2024 decreased versus the prior year period, primarily due to completion of the U.S. Phase 3 ReCePI clinical trial for INTERCEPT RBCs.

Product Gross Profit & Margin

Product gross profit for the third quarter of 2024 was $26.2 million, increasing by 20% over the prior year period. Product gross margin for the third quarter of 2024 improved to 56.9% compared to 54.9% for the prior year period. Absent any unanticipated factor, Cerus expects product gross margin levels to remain relatively consistent for the fourth quarter.

Operating Expenses

Total operating expenses for the third quarter of 2024 were $31.8 million, compared to $34.5 million for the same period of the prior year, reflecting a decrease of 8%. This decline resulted from decreases in R&D, partially offset by increases in selling, general and administrative (SG&A) expenses.

R&D expenses for the third quarter of 2024 were $14.0 million, compared to $16.8 million for the prior year period. The primary drivers for the decrease in R&D expenses were the completion of the Company’s ReCePI Phase 3 clinical trial during the first quarter of 2024 and the full impact of the previous year’s restructuring.

SG&A expenses for the third quarter of 2024 were $17.8 million, compared to $16.2 million for the prior year period. The primary driver for the increase in SG&A expenses was non-cash stock-based compensation. The Company continues to expect SG&A expenses will be relatively consistent for the balance of the year, driving increased leverage at these levels.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the third quarter of 2024 was $2.9 million, or $0.02 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $7.3 million, or $0.04 per basic and diluted share, for the third quarter of 2023. Net loss attributable to Cerus Corporation for the first nine months of 2024 was $18.4 million, compared to a net loss attributable to Cerus Corporation of $36.2 million for the first nine months of 2023.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the third quarter of 2024 was a positive $4.4 million, compared to a loss of $1.0 million for the third quarter of 2023. Non-GAAP adjusted EBITDA was a positive $2.5 million for the first nine months of 2024, compared to a loss of $15.5 million for the first nine months of 2023. The Company continues to focus on achieving non-GAAP adjusted EBITDA breakeven for the full-year 2024. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet & Cash Flows

At September 30, 2024, the Company had cash and cash equivalents and short-term investments of $75.6 million, compared to $71.2 million at June 30, 2024, and $65.9 million at December 31, 2023.

As of September 30, 2024, the Company had $65.0 million outstanding on its term loan and $18.5 million drawn on its revolving credit facility. The Company’s revolving line of credit allows for an additional $16.5 million, which is dependent on eligible assets supporting the borrowing base.

For the third quarter of 2024, the Company generated positive cash flows of $4.1 million from operations compared to cash used in operations of $10.5 million during the prior year period. These improvements were in line with the Company’s expectations and will continue to be a focus area going forward.

Raising 2024 Product Revenue Guidance

The Company is raising its full-year 2024 product revenue guidance to a range of $177 million to $179 million from the prior range of $175 million to $178 million. Alongside this raise in guidance, the Company is raising the bottom end of its full-year 2024 IFC revenue guidance to a new range of $9 million to $10 million from $8 million to $10 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through November 20, 2024.

On October 30, 2024 Biogen Inc. (NASDAQ: BIIB) reported third quarter 2024 financial results (Press release, Biogen, OCT 30, 2024, View Source [SID1234647534]). Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In the third quarter Biogen made continued progress toward our goal of returning to sustainable growth. We continue to see momentum with ongoing product launches and we are increasingly excited about the potential of our pipeline. This quarter we had several significant positive developments in key areas of our late-stage pipeline which we believe underscore the potential value for both patients and shareholders. Importantly, the positive results for dapirolizumab pegol, as well as recent presentations of felzartamab data in IgAN, bolster our efforts to develop an industry-leading pipeline in immunology, where we are building upon data insights and increasing our capabilities to prepare for potential future launches."

Financial Highlights
Q3 ’24 Q3 ’23 △
r (CC*)
Total Revenue (in millions) $2,466 $2,530 (3)% (3)%
GAAP diluted EPS $2.66 $(0.47) 666% N/A
Non-GAAP diluted EPS $4.08 $4.36 (6)% N/A

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
N/A = not applicable.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q3 ’24 Q3 ’23 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,054 $1,159 (9)% (9)%
Rare disease revenue(2)
$495 $450 10% 10%
Biosimilars revenue $197 $194 1% —%
Other product revenue(3)
$24 $2 NMF NMF
Total product revenue $1,769 $1,805 (2)% (2)%
Revenue from anti-CD20 therapeutic programs $446 $421 6% 6%
Contract manufacturing, royalty and other revenue $250 $304 (18)% (19)%
Total revenue $2,466 $2,530 (3)% (3)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
NMF = no meaningful figure.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
•Third quarter 2024 ZURZUVAE revenue was approximately $22 million.
Expense Summary
(in millions) Q3 ’24 Q3 ’23 △
GAAP cost of sales*
$639 $660 3%
% of Total Revenue 26% 26%
Non-GAAP cost of sales*
$593 $660 10%
% of Total Revenue 24% 26%
GAAP R&D expense $543 $736 26%
Non-GAAP R&D expense $491 $539 9%
GAAP SG&A expense $588 $788 25%
Non-GAAP SG&A expense $556 $553 (1)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
* Excluding amortization and impairment of acquired intangible assets

•The decrease in third quarter 2024 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in revenue from new
2

product launches and decrease in contract manufacturing revenue, as well as lower idle capacity charges.

•In the third quarter 2024 as compared to the third quarter of 2023, the decrease in GAAP R&D of approximately $194 million was primarily driven by approximately $197 million of equity-based compensation expense recognized in 2023 related to the Reata Pharmaceuticals, Inc. (Reata) acquisition, cost-reduction measures realized in 2024 in connection with the Company’s R&D prioritization and Fit for Growth initiatives, as well as higher spend on clinical trials and close out costs incurred during 2023, partially offset by approximately $43 million of equity-based compensation expense recognized in 2024 related to the Human Immunology Biosciences, Inc. (HI-Bio) acquisition.

•In the third quarter 2024 as compared to the third quarter of 2023, the decrease in Non-GAAP R&D of approximately $48 million was primarily due to cost-reduction measures realized in 2024 in connection with the Company’s R&D prioritization and Fit for Growth initiatives, as well as higher spend on clinical trials and close out costs incurred during 2023.

•In the third quarter 2024 as compared to the third quarter of 2023, the decrease in GAAP SG&A expense of approximately $200 million was primarily due to approximately $196 million of equity-based compensation expense recognized in 2023 related to the acquisition of Reata and cost-reduction measures realized in 2024 in connection with the Company’s Fit for Growth initiative.

•In the third quarter 2024 as compared to the third quarter of 2023, the increase in Non-GAAP SG&A expense of approximately $3 million was primarily due to increased commercialization spend related to new product launches, partially offset by savings achieved from the Company’s Fit for Growth initiative.
Other Financial Highlights

•Third quarter 2024 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $69 million, which includes approximately $60 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $9 million related to Biogen’s collaboration with Sage Therapeutics, Inc. (Sage) and the commercialization of ZURZUVAE in the U.S.

•Third quarter 2024 GAAP other expense was approximately $15 million, primarily driven by net interest expense, partially offset by net realized and unrealized gains on strategic equity investments of approximately $39 million. Third quarter 2024 Non-GAAP other expense was approximately $54 million, primarily driven by net interest expense.

•Third quarter 2024 GAAP and Non-GAAP effective tax rates were 13.9% and 13.8%, respectively. Third quarter 2023 GAAP and Non-GAAP effective tax rates were 51.6% and 14.7%, respectively.
Financial Position

•Third quarter 2024 net cash flow from operations was approximately $936 million. Capital expenditures were approximately $35 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $901 million.

•As of September 30, 2024, Biogen had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $4.6 billion.

•No shares of the Company’s common stock were repurchased in the third quarter of 2024. As of September 30, 2024, there was approximately $2.1 billion remaining under the share repurchase program authorized in October 2020.

•For the third quarter of 2024 the Company’s weighted average diluted shares were approximately 146 million.

Full Year 2024 Financial Guidance

For the full year 2024, Biogen now expects a Non-GAAP diluted EPS guidance range as follows:
Prior FY 2024 Guidance Updated FY 2024 Guidance
Non-GAAP diluted EPS
$15.75 to $16.25
Reflecting growth of ~9% at the mid-point*
$16.10 to $16.60
Reflecting growth of ~11% at the mid-point*

*Versus reported full year 2023

Biogen continues to expect total revenue to decline by a low-single digit percentage, with core pharmaceutical revenue, defined as product revenue plus Biogen’s 50% share of net LEQEMBI product revenue and cost of sales, including royalties, to be relatively flat for 2024 compared to 2023 as further declines in multiple sclerosis product revenue are expected to be offset by increases in revenue from new product launches.

Biogen continues to expect an improvement in the cost of sales as a percentage of total revenue for 2024 compared to 2023 driven by product mix and significantly lower idle capacity charges.

For 2024 compared to 2023, Biogen expects operating income to grow at a high-teen percentage with mid-single digit percentage point operating margin improvement. This is expected to be driven by improved cost of sales as a percentage of revenue, as well as lower operating expenses as a result of the Company’s Fit for Growth and R&D prioritization initiatives.

This financial guidance does not include any impact from potential acquisitions or business development transactions or pending and future litigation or any impact of potential tax or healthcare reform, as all are hard to predict.

This guidance also assumes that foreign exchange rates as of October 25, 2024, will remain in effect for the remainder of the year, net of hedging activities. Other modeling considerations will be provided on the conference call and webcast.

Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2024 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from equity security investments; and the ultimate outcome of pending or future significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Key Recent Events

•In October, Biogen and Sage decided they will not pursue further development for zuranolone as a treatment for major depressive disorder.

Conference Call and Webcast

The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:30 a.m. ET on October 30, 2024 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.