On July 31, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended June 30, 2025 (Press release, Corcept Therapeutics, JUL 31, 2025, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-3 [SID1234654671]).

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Financial Results

"The second quarter marked another period of robust growth in our hypercortisolism business. Once again, we had a record number of new prescribers and a record number of new patients receiving treatment. Physicians increasingly recognize hypercortisolism’s true prevalence and the necessity of appropriate treatment, which has led to increased screening and diagnosis. Our financial results don’t fully reflect this surge in demand, which outpaced our specialty pharmacy vendor’s capacity. We expect improved performance by our current vendor, as well as contribution from a second pharmacy that is coming online soon, in the coming quarters and have modified our 2025 revenue guidance to $850 – $900 million," said Joseph K. Belanoff, M.D., Corcept’s Chief Executive Officer.

Corcept’s second quarter 2025 revenue was $194.4 million, compared to $163.8 million in the second quarter of 2024. Second quarter 2025 operating expenses were $167.8 million, compared to $128.2 million in the same period last year. Net income per common share (diluted) was $0.29 in the second quarter of 2025, compared to $0.32 in the second quarter of 2024.

Cash and investments were $515.0 million at June 30, 2025, compared to $570.8 million at March 31, 2025. The balance at June 30, 2025 reflects the acquisition of $115.4 million of common stock in the second quarter pursuant to the company’s stock repurchase program, net exercise of employee stock options and net vesting of restricted stock grants.

Clinical Development

"We achieved many important clinical development milestones in the second quarter. Results of Part 1 and Part 2 of our CATALYST study were published in Diabetes Care in April and June. Our ROSELLA study’s results were published in The Lancet in June. We have two New Drug Applications (NDAs) in progress – one in hypercortisolism and another in platinum-resistant ovarian cancer. We are discussing with regulators the optimal development and regulatory path for dazucorilant which, in our Phase 2 DAZALS trial, prevented early death in patients with ALS. In addition, we continue to investigate how cortisol modulation can benefit patients with a broad range of serious disorders, including Metabolic Dysfunction-Associated Steatohepatitis (MASH)," added Dr. Belanoff.

Hypercortisolism (Cushing’s Syndrome)

Relacorilant for patients with hypercortisolism – FDA review of NDA continues, with Prescription Drug User Fee Act (PDUFA) date of December 30, 2025
CATALYST Part 1 – Prevalence of hypercortisolism in patients with difficult-to-control type 2 diabetes – Results published in Diabetes Care (Buse et al, April 2025)
CATALYST Part 2 – Randomized, double-blind, placebo-controlled study of Korlym in 136 patients with hypercortisolism and difficult-to-control type 2 diabetes – Results presented at the American Diabetes Association’s 85th Scientific Sessions; published in Diabetes Care (DeFronzo et al, June 2025)
MOMENTUM – Enrollment continues in 1,000-patient trial examining the prevalence of hypercortisolism in patients with resistant hypertension – Results expected by year-end
"CATALYST is a landmark study in hypercortisolism, a serious and deadly disease that too often goes undetected," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "CATALYST Part 1 showed that one in every four patients with difficult-to-control type 2 diabetes has hypercortisolism. CATALYST Part 2 showed that treatment with a cortisol modulator can be highly effective in improving their signs and symptoms. These powerful findings provide important guidance for physicians and will accelerate screening and treatment of patients with hypercortisolism."

"We continue to work toward relacorilant’s approval. In our studies, patients who received relacorilant exhibited clinically and statistically significant improvements in a wide array of hypercortisolism’s signs and symptoms, without the off-target effects and toxicities that accompany currently available treatments," added Dr. Guyer. "Relacorilant has the potential to become the standard of care for patients with this devastating disease."

Oncology

NDA submitted in July 2025 for relacorilant to treat patients with platinum-resistant ovarian cancer – Submission of European Marketing Authorization Application (MAA) expected this quarter
ROSELLA – Primary endpoint met in pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in 381 patients with platinum-resistant ovarian cancer – Results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 annual meeting and published in The Lancet (Olawaiye et al, June 2025)
BELLA – Enrollment continues briskly in Phase 2 trial of relacorilant plus nab-paclitaxel and bevacizumab in 90 patients with platinum-resistant ovarian cancer
Early-stage prostate cancer – Enrollment continues in randomized, placebo-controlled, Phase 2 trial of relacorilant plus enzalutamide in patients with early-stage prostate cancer, conducted in collaboration with the University of Chicago
"Our NDA for relacorilant to treat patients with platinum-resistant ovarian cancer is based on the results of our pivotal ROSELLA study, which confirmed the positive results of our Phase 2 study. The progression-free and overall survival improvements in patients who received relacorilant, with no increase in safety burden and without the requirement of biomarker screening, are groundbreaking," said Dr. Guyer. "We look forward to working with the FDA as it reviews our NDA and submitting our MAA later this quarter."

"The BELLA study builds on ROSELLA’s findings, assessing the safety and efficacy of combining relacorilant with two medications – nab-paclitaxel and bevacizumab – to treat patients with platinum-resistant ovarian cancer. Separately, we expect that relacorilant can help treat earlier stages of ovarian cancer and other solid tumors and will soon initiate additional clinical trials."

Amyotrophic Lateral Sclerosis (ALS)

DAZALS – Exploratory analysis showed that patients receiving dazucorilant 300 mg exhibited an 84 percent reduction in risk of death during the study’s first year compared to patients receiving placebo (hazard ratio: 0.16, p-value: 0.0009)
DAZALS – Results presented at European Network to Cure ALS (ENCALS) annual meeting in June 2025
"ALS is a devastating disease. In DAZALS, dazucorilant did not meet its primary endpoint of improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R). However, patients who received dazucorilant 300 mg daily had an 84 percent lower chance of dying during the study’s first year compared to patients who received placebo (hazard ratio: 0.16, p-value: 0.0009)," said Dr. Guyer. "Reducing mortality from the start of treatment, when many patients retain considerable function, is an important benefit. We are working with regulatory authorities to determine the fastest path forward."

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

MONARCH – Enrollment nearly complete in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH
"In our Phase 1b study, miricorilant reduced liver fat very rapidly, improved liver health and key metabolic and lipid measures and was well-tolerated. We look forward to building on these promising results in our Phase 2b MONARCH study. Enrollment will complete in the coming weeks with first results expected by the end of next year," said Dr. Guyer.

Conference Call

We will hold a conference call on July 31, 2025, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. A listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of Corcept.com.

On July 31, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the second quarter of 2025 (Press release, Bristol-Myers Squibb, JUL 31, 2025, View Source [SID1234654670]).

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"We are making good progress rewiring the company for long-term growth. In the second quarter, we delivered strong results across our Growth Portfolio, continued to optimize our cost structure, and added to our innovative pipeline with strategic partnerships," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "In the back half of the year, we’re focused on advancing transformational medicines and delivering on our Growth Portfolio and important pipeline opportunities to shape our growth trajectory."

Second Quarter Results
$ in millions, except per share amounts 2025 2024 Change
Change Excl. FX**
Total Revenues $12,269 $12,201 1 % 0 %
Earnings/(Loss) Per Share – GAAP* 0.64 0.83 (22) % N/A
Earnings/(Loss) Per Share – Non-GAAP* 1.46 2.07 (29) % N/A
Acquired IPRD Charge and Licensing Income Net Impact on Earnings/(Loss) Per Share (0.57) (0.04) N/A N/A

SECOND QUARTER RESULTS
All comparisons are made versus the same period in 2024 unless otherwise stated.
•Growth Portfolio revenues of $6.6 billion increased 18%, or 17% Ex-FX. Revenue growth was primarily driven by our immuno-oncology (IO) portfolio, Breyanzi, Reblozyl and Camzyos, and reflects the continued strength of Cobenfy.
•Legacy Portfolio revenues of $5.7 billion decreased 14%, or 15% Ex-FX. Demand increased for Eliquis, offset by expected continued generic impact across the remainder of the Legacy Portfolio, as well as the impacts from U.S. Medicare Part D redesign.
•Total revenues of $12.3 billion increased 1%, and were relatively flat Ex-FX.
◦U.S. revenues of $8.5 billion decreased 3%.
◦International revenues of $3.8 billion increased 10%, or 8% Ex-FX.
SECOND QUARTER PRODUCT REVENUE HIGHLIGHTS(d)

($ amounts in millions) Quarter Ended June 30, 2025
% Change from Quarter Ended June 30, 2024
% Change from Quarter Ended June 30, 2024 Ex-FX**

U.S.
Int’l
WW(c)
U.S.
Int’l
WW(c)
Int’l
WW(c)
Growth Portfolio
Opdivo $ 1,506 $ 1,053 $ 2,560 7 % 7 % 7 % 7 % 7 %
Opdivo Qvantig 28 1 30 N/A N/A N/A N/A N/A
Orencia 711 252 963 (4) % 23 % 2 % 20 % 1 %
Yervoy 451 277 728 12 % 22 % 16 % 21 % 15 %
Reblozyl 453 114 568 30 % 51 % 34 % 46 % 33 %
Opdualag 252 32 284 13 % 161 % 21 % 155 % 20 %
Breyanzi 255 88 344 110 % 183 % 125 % 167 % 122 %
Camzyos 214 46 260 65 % >200% 87 % >200% 86 %
Zeposia 105 46 150 (5) % 15 % — % 10 % (2) %
Abecma 47 40 87 (14) % (1) % (8) % (7) % (11) %
Sotyktu 43 27 70 5 % 116 % 31 % 109 % 29 %
Krazati 47 2 48 58 % (32) % 51 % (33) % 51 %
Cobenfy 35 — 35 N/A N/A N/A N/A N/A
Other Growth Products(a)
201 269 470 15 % 56 % 35 % 55 % 35 %
Total Growth Portfolio
4,348 2,248 6,596 15 % 24 % 18 % 23 % 17 %
Legacy Portfolio
Eliquis 2,654 1,027 3,680 4 % 18 % 8 % 12 % 6 %
Revlimid 732 106 838 (37) % (44) % (38) % (44) % (38) %
Pomalyst/Imnovid 584 124 708 (18) % (49) % (26) % (51) % (27) %
Sprycel 68 52 120 (80) % (38) % (72) % (38) % (72) %
Abraxane 33 72 105 (79) % (7) % (55) % (5) % (54) %
Other Legacy Products(b)
100 123 223 5 % (4) % (1) % (5) % (1) %
Total Legacy Portfolio
4,171 1,503 5,673 (17) % (6) % (14) % (9) % (15) %
Total Revenues $ 8,519 $ 3,750 $ 12,269 (3) % 10 % 1 % 8 % — %

** See "Use of Non-GAAP Financial Information".
(a) Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenue.
(b) Includes other mature brands.
(c) Worldwide (WW) includes U.S. and International (Int’l).
(d) For the above table and all subsequent tables, certain totals may not sum due to rounding. Percentages have been calculated using unrounded amounts.
2

SECOND QUARTER COST & EXPENSES
All comparisons are made versus the same period in 2024 unless otherwise stated.
The table below presents selected line-item information.

Three Months Ended June 30, 2025 Three Months Ended June 30, 2024
($ amounts in millions)
GAAP
Specified Items**
Non-GAAP
GAAP
Specified Items**
Non-GAAP
Cost of products sold
$ 3,372 (16) $ 3,356 $ 3,267 (296) $ 2,971
Gross margin(a)
72.5 % 72.6 % 73.2 % 75.6 %
Selling, general and administrative
1,713 (22) 1,691 1,928 (6) 1,922
Research and development
2,580 (318) 2,263 2,899 (604) 2,295
Acquired IPRD
1,508 — 1,508 132 — 132
Amortization of acquired intangible assets
830 (830) — 2,416 (2,416) —
Other (income)/expense, net
494 (602) (108) 273 (277) (4)
Effective tax rate
25.9 % (9.8) % 16.1 % (30.9) % 45.0 % 14.1 %

**See "Use of Non-GAAP Financial Information" and refer to the Specified Items schedule below for further detail.
(a) Represents revenue minus cost of products sold divided by revenue.

•Gross margin decreased from 73.2% to 72.5% on a GAAP basis, and from 75.6% to 72.6% on a non-GAAP basis, primarily due to product mix.
•Selling, general and administrative expenses of $1.7 billion decreased 11% on a GAAP basis and 12% on a non-GAAP basis, primarily driven by our ongoing strategic productivity initiative.
•Research and development expenses of $2.6 billion decreased 11% on a GAAP basis, primarily due to lower IPRD impairment charges. Non-GAAP research and development expenses of $2.3 billion decreased 1%, primarily driven by our ongoing strategic productivity initiative.
•Acquired IPRD charges of $1.5 billion increased from $132 million on a GAAP and non-GAAP basis, primarily driven by the execution of a strategic partnership with BioNTech in June 2025.
•Amortization of acquired intangible assets of $830 million decreased 66% on a GAAP basis, primarily due to lower amortization expense related to Revlimid.
•Effective tax rate in 2025 on a GAAP and non-GAAP basis was 25.9% and 16.1%, respectively. The 2024 GAAP effective tax rate was impacted by the release of income tax reserves.
•Net income attributable to Bristol Myers Squibb of $1.3 billion, or $0.64 per share, decreased from $1.7 billion, or $0.83 per share, on a GAAP basis. On a non-GAAP basis, net income attributable to Bristol Myers Squibb of $3.0 billion, or $1.46 per share, decreased from $4.2 billion, or $2.07 per share. GAAP and non-GAAP EPS include the impacts of Acquired IPRD.

PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of second quarter and recent updates.
Asset(s)
Date Announced
Milestone
Sotyktu (deucravacitinib)
July 21
The U.S. Food and Drug Administration (FDA) accepted for review the supplemental New Drug Application (sNDA) for Sotyktu based on positive results from the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials for the treatment of adults with active psoriatic arthritis. The FDA assigned a Prescription Drug User Fee Act goal date of March 6, 2026.

In addition, China’s Center for Drug Evaluation of National Medical Products Administration and Japan’s Ministry of Health, Labour and Welfare accepted sNDAs for Sotyktu in the same indication. The European Medicines Agency (EMA) has also validated the Type II variation application to expand the indication for Sotyktu to include this disease.
Reblozyl (luspatercept)
July 18
The Phase 3 INDEPENDENCE trial evaluating Reblozyl with concomitant janus kinase inhibitor therapy in adult patients with myelofibrosis-associated anemia receiving red blood cell (RBC) transfusions did not meet its primary endpoint of RBC transfusion independence during any consecutive 12-week period, starting within the first 24 weeks of treatment, compared to placebo. Patients saw a numerical and clinically meaningful improvement in RBC transfusion independence favoring Reblozyl, in line with previous results from the Phase 2 trial.

The company will engage with the FDA and EMA, and plans to engage other health authorities to discuss the submission of marketing applications.
Eliquis (apixaban)
July 17
The BMS-Pfizer Alliance announced a new direct-to-patient option for purchasing Eliquis via the Alliance’s patient resource, Eliquis 360 Support. This option offers uninsured, underinsured or self-pay patients an opportunity to significantly lower out-of-pocket costs for Eliquis.
Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel)
June 26
The FDA approved label updates for CAR T cell therapies Breyanzi and Abecma that reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that were in place since each product was initially approved.
Breyanzi June 16
Primary analysis results of the marginal zone lymphoma cohort of the Phase 2 TRANSCEND FL study evaluating Breyanzi in patients with relapsed or refractory disease demonstrated high rates of durable responses and a consistent safety profile in a fifth cancer type.
Subcutaneous formulation of Opdivo (nivolumab)
May 28
The European Commission (EC) approved a new Opdivo formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form, and a new strength. Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance following completion of intravenous nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
Opdivo
May 16
The EC approved the perioperative regimen of neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.

Business Development
The company recently entered into multiple transactions that enhanced its portfolio and pipeline.
In June 2025, the company entered into an agreement with BioNTech for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types. Under the agreement, BioNTech and BMS will work jointly to broaden and accelerate the development of this clinical candidate.
Also in June 2025, RayzeBio, Inc., a Bristol Myers Squibb company, entered into a definitive agreement under which Philochem AG, a wholly-owned subsidiary of the Philogen Group, will license the exclusive worldwide rights to develop, manufacture and commercialize OncoACP3, a clinical-stage therapeutic and diagnostic agent targeting prostate cancer, to RayzeBio. The transaction is expected to close in the third quarter of 2025 following the receipt of necessary regulatory approvals and the satisfaction of other customary closing conditions.
In July 2025, the company announced the creation of a new, independent biopharmaceutical company with Bain Capital focused on developing new therapies for autoimmune diseases that address significant unmet needs of patients. The newly formed company launches with five immunology assets in-licensed from Bristol Myers Squibb and a $300 million financing commitment that was led by Bain Capital.
Financial Guidance
Bristol Myers Squibb is increasing its full-year 2025 non-GAAP revenue guidance from a range of approximately $45.8 billion to $46.8 billion, to a range of approximately $46.5 billion to $47.5 billion, reflecting the strength of the Growth Portfolio, better-than-expected Legacy Portfolio sales in the second quarter, and a favorable impact of approximately $200 million related to foreign exchange rates.
Full-year operating expense expectations are now approximately $16.5 billion, reflecting the investment behind recent business development transactions and the identification of additional investment opportunities within our Growth Portfolio. The company now anticipates other income and expense in 2025 to be approximately $250 million of income due to higher-than-anticipated royalties and favorable interest income.
Non-GAAP EPS is now expected to be in the range of $6.35 – $6.65, inclusive of an unfavorable $(0.57) per share impact from the BioNTech Acquired IPRD charge this quarter.
5

Non-GAAP2,3

April
(Prior)
July
(Updated)4
Total Revenues
(Reported & Ex-FX)
~$45.8 – $46.8 billion
~$46.5 – $47.5 billion
Gross Margin %
~72%
No change
Operating Expenses1
~$16.2 billion
~$16.5 billion
Other income/(expense)
~$100 million
~$250 million
Effective tax rate
~18%
No change
Diluted EPS $6.70 – $7.00
$6.35 – $6.65
BioNTech Acquired IPRD Charge Included in Diluted EPS
— $(0.57)

1 Operating Expenses = SG&A and R&D.
2 See "Use of Non-GAAP Financial Information."
3 April was calculated using foreign exchange rates as of April 23, 2025, and July was calculated using foreign
exchange rates as of July 25, 2025.
4 Guidance includes Acquired IPRD charges through Q2 2025, and does not include Acquired IPRD either incurred,
or expected to be incurred, after June 30, 2025.

The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income, including any potential Acquired IPRD charges associated with the Philochem transaction, which is expected to close in the third quarter of 2025, subject to customary closing conditions. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com, in the "Investors" section. Non-GAAP guidance assumes exchange rates as of the date noted. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on
6

various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."

Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, July 31, 2025, at 8:00 a.m. ET, during which company executives will review financial results with the investment community.
Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Materials related to the call will be available at View Source prior to the start of the conference call.
A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

On July 31, 2025 Biogen Inc. (NASDAQ: BIIB) reported second quarter 2025 financial results (Press release, Biogen, JUL 31, 2025, View Source [SID1234654669]). Commenting on the results, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We delivered another quarter of strong execution against our strategy to transform our portfolio and build the new Biogen. Our performance reflects robust financial results, ongoing cost discipline, continued growth of our launch products, and meaningful strides expanding and advancing our late-stage pipeline. We are now progressing salanersen to registrational studies in SMA following exciting interim Phase 1b results, and have initiated all three Phase 3 studies for felzartamab in rare kidney disease. These achievements reinforce our commitment to building a stronger company, with the potential for sustainable growth and long-term value for our shareholders."

Financial Highlights
Q2 ’25 Q2 ’24 △
r (CC*)
Total Revenue (in millions) $2,646 $2,465 7% 8%
GAAP diluted EPS $4.33 $4.00 8% N/A
Non-GAAP diluted EPS $5.47 $5.28 4% 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.

Second quarter 2025 GAAP and Non-GAAP diluted EPS reflects the approximately ($0.26) impact from $47 million of acquired IPR&D, upfront and milestone expense.

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) Q2 ’25 Q2 ’24 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,107 $1,150 (4)% (4)%
Rare disease revenue(2)
$543 $534 2% 3%
Biosimilars revenue $182 $198 (8)% (8)%
Other product revenue(3)
$47 $18 169% 170%
Total product revenue $1,879 $1,900 (1)% (1)%
Revenue from anti-CD20 therapeutic programs $467 $445 5% 5%
Alzheimer’s collaboration revenue(4)
$55 $12 NMF NMF
Contract manufacturing, royalty and other revenue $245 $109 124% 119%
Total revenue $2,646 $2,465 7% 8%

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. Effective
January 1, 2025, our collaboration and license agreement for FAMPYRA global commercialization rights was terminated.
(2) Rare disease includes SPINRAZA, SKYCLARYS and QALSODY.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
(4) Includes Biogen’s 50% share of net revenue and cost of sales, including royalties, from the LEQEMBI Collaboration.
Expense Summary
(in millions) Q2 ’25 Q2 ’24 △
GAAP cost of sales*
$605 $546 (11)%
% of Total Revenue 23% 22%
Non-GAAP cost of sales*
$554 $504 (10)%
% of Total Revenue 21% 20%
GAAP R&D expense $399 $505 21%
Non-GAAP R&D expense $394 $455 13%
GAAP SG&A expense $584 $554 (5)%
Non-GAAP SG&A expense $579 $542 (7)%
GAAP acquired IPR&D, upfront and milestone expense $47 $9 NMF
Non-GAAP acquired IPR&D, upfront and milestone expense $47 $9 NMF

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
IPR&D = in-process R&D; NMF = no meaningful figure.
* Excluding amortization and impairment of acquired intangible assets

2

•The increase in second quarter 2025 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 contract manufacturing revenue driven in-part by accelerated batch production in preparation for expected plant maintenance shutdowns in the fourth quarter of 2025, partially offset by an increase in launch product revenue.

•The decrease in second quarter 2025 GAAP and Non-GAAP R&D expense was driven primarily by savings from the Company’s R&D prioritization, Fit for Growth initiatives and R&D funding received.

•The increase in second quarter 2025 GAAP and Non-GAAP SG&A was driven primarily by sales and marketing spend to support product launches, partially offset by savings from the Company’s Fit for Growth initiative.

•Second quarter 2025 GAAP and Non-GAAP acquired IPR&D, upfront and milestone expense was approximately $47 million and includes a $30 million milestone to MorphoSys AG as part of the initiation of the Phase 3 trial of felzartamab in IgA nephropathy and a $16 million upfront payment as part of a strategic research agreement with City Therapeutics, Inc.
Other Financial Highlights

•Second quarter 2025 GAAP and Non-GAAP collaboration profit sharing was a net expense of approximately $75 million, which includes approximately $57 million related to Biogen’s collaboration with Samsung Bioepis, and approximately $18 million related to Biogen’s collaboration with Sage Therapeutics, Inc. and the commercialization of ZURZUVAE in the U.S.

•Second quarter 2025 GAAP other expense was approximately $49 million, primarily driven by net interest expense and impacts from foreign currency. Second quarter 2025 Non-GAAP other expense was approximately $57 million, primarily driven by net interest expense.

•Second quarter 2025 GAAP and Non-GAAP effective tax rates were 14.7% and 13.5%, respectively. Second quarter 2024 GAAP and Non-GAAP effective tax rates were 16.5% and 15.9%, respectively.
Financial Position

•Second quarter 2025 net cash flow from operations was approximately $161 million and includes the impact of cash tax payments of approximately $745 million. Capital expenditures were approximately $27 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was approximately $134 million.

•As of June 30, 2025, Biogen had cash and cash equivalents totaling approximately $2.8 billion and approximately $6.3 billion in total debt, resulting in net debt of approximately $3.5 billion.

•For the second quarter of 2025 the Company’s weighted average diluted shares were approximately 147 million.

On July 31, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) (the "Company"), reported the closing of its previously announced public offering of an aggregate of 2,000,000 shares of its common stock (or pre-funded warrants in lieu thereof), Class E warrants to purchase up to 2,000,000 shares of common stock, and Class F warrants to purchase up to 2,000,000 shares of common stock, at a combined public offering price of $4.00 per share (or $3.999 per pre-funded warrant) and accompanying warrants (Press release, AIM ImmunoTech, JUL 31, 2025, View Source [SID1234654666]). The warrants have an exercise price of $4.00 per share, and were exercisable immediately upon issuance. The Class E warrants will expire on the fifth anniversary of the original issuance date, and the Class F warrants will expire on the eighteen-month anniversary of the original issuance date. Gross proceeds, before deducting placement agent fees and offering expenses, were approximately $8.0 million.

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Maxim Group LLC acted as sole placement agent in connection with this offering.

The securities described above were being offered pursuant to a registration statement on Form S-1, as amended (File No. 333-284443) (the "Registration Statement"), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 28, 2025. Copies of the final prospectus relating to this offering have been filed with the SEC and may be obtained from Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, NY 10022, at (212) 895-3745.

On July 31, 2025 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported financial results and updates for the second quarter ended June 30, 2025 (Press release, Agios Pharmaceuticals, JUL 31, 2025, View Source [SID1234654665]).

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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

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"With fewer than 40 days to our PDUFA goal date, our commercial team is prepared for the potential U.S. approval of PYRUKYND for thalassemia," said Brian Goff, Chief Executive Officer, Agios. "In the second quarter, we made progress advancing our early- and mid-stage pipeline and remain on track to deliver topline results of the RISE UP Phase 3 trial for PYRUKYND in sickle cell disease by the end of the year. Collectively, our progress reflects our continued focus on delivering innovative medicines with the potential to transform the lives of those affected by rare diseases and deliver long-term shareholder value."

Second Quarter 2025 and Recent Corporate Highlights

Commercial Performance – PYRUKYND (mitapivat)

Generated $12.5 million in net revenue for the second quarter of 2025, compared to $8.6 million in the second quarter of 2024.
248 unique patients completed prescription enrollment forms, representing an increase of 6 percent over the first quarter of 2025.
142 patients are on PYRUKYND therapy, inclusive of new starts and continued therapy, representing an increase of 4 percent over the first quarter of 2025.
Entered into a distribution agreement with Avanzanite Bioscience B.V., a rapidly growing European specialty pharmaceutical company focused on rare diseases, to distribute and commercialize PYRUKYND across the European Economic Area, the United Kingdom and Switzerland.
R&D Highlights

PYRUKYND (mitapivat)
Thalassemia –
Launch preparations underway ahead of U.S. PDUFA goal date of September 7, 2025. The sNDA for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia remains under active review by the U.S. Food and Drug Administration (FDA).
Other regulatory applications remain under review by health authorities in Saudi Arabia, United Arab Emirates, and the European Union.
Sickle Cell Disease –
Topline results from RISE UP Phase 3 trial of mitapivat in sickle cell disease on track by year-end with potential U.S. commercial launch in 2026.
Tebapivat
Sickle Cell Disease –
Dosed the first patient in the Phase 2 trial investigating tebapivat in sickle cell disease. The trial is enrolling across three dose cohorts (2.5mg, 5mg, 7.5mg) and placebo and the primary endpoint will measure hemoglobin response, defined as a ≥1g/dL increase in hemoglobin concentration from week 10 to week 12, compared to baseline.
Lower-risk Myelodysplastic Syndromes (LR-MDS) –
Continue to progress patient enrollment in the Phase 2b trial for tebapivat in LR-MDS with target enrollment completion by the end of 2025.
Early Pipeline
Investigational New Drug (IND) clearance received for AG-236, an siRNA targeting TMPRSS6 intended for the treatment of polycythemia vera (PV).
Presented new data on mitapivat and tebapivat at the 30th European Hematology Association (EHA) (Free EHA Whitepaper) Congress. A total of 14 presentations and publications, led by Agios and external collaborators, were shared, covering sickle cell disease, thalassemia, PK deficiency, and MDS.
Second Quarter 2025 Financial Results

For the quarter ended June 30, 2025, net loss was $112.0 million dollars, compared to a net loss of $96.1 million dollars for the second quarter ended June 30, 2024.

Net product revenue from sales of PYRUKYND for the second quarter of 2025 was $12.5 million, compared to $8.6 million for the second quarter of 2024.
Cost of sales for the second quarter of 2025 was $1.7 million.
Research and Development (R&D) Expenses were $91.9 million for the second quarter of 2025, compared to $77.4 million for the second quarter of 2024. The year-over-year increase was primarily attributed to a $10.0 million regulatory milestone payment to Alnylam associated with our agreement to develop and commercialize AG-236, an siRNA targeting TMPRSS6, intended for the treatment of polycythemia vera.
Selling, General and Administrative (SG&A) Expenses were $45.9 million for the second quarter of 2025 compared to $35.5 million for the second quarter of 2024. The year-over-year increase was primarily attributable to an increase in commercial-related activities, including headcount, as the company prepares for the potential approval of PYRUKYND in thalassemia.
Cash, cash equivalents and marketable securities as of June 30, 2025, were $1.3 billion compared to $1.5 billion as of December 31, 2024. Agios expects that its cash, cash equivalents and marketable securities, together with anticipated product revenue and interest income, will provide the financial independence to prepare for potential PYRUKYND launches in thalassemia and sickle cell disease, advance existing programs, and opportunistically expand its pipeline through both internally and externally discovered assets.
Conference Call Information

Agios will host a conference call and live webcast today at 8:00 a.m. ET to discuss the company’s second quarter 2025 financial results and recent business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.