On August 7, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the second quarter ended June 30, 2025, and provided a recap of recent program and corporate developments (Press release, Disc Medicine, AUG 7, 2025, View Source [SID1234654973]).

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"We are pleased with the continued momentum this past quarter, highlighted by clinical data presentations that support further advancement across our programs and continued progress toward our first NDA submission. Following positive feedback from our pre-NDA meeting, we are on track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in October," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We have also made great progress across the rest of our pipeline, initiating a Phase 2 study of DISC-3405 in polycythemia vera, and looking ahead to data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the second half of the year. Our team’s commitment to execution, supported by a strong balance sheet that provides cash runway into 2028, has positioned Disc to prepare for the potential commercialization of bitopertin and advance pipeline development as we enter the next phase of growth."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyTI Inhibitor (Heme Synthesis Modulator)

Presented data from HELIOS, an ongoing open-label extension study of bitopertin in EPP, which showed favorable long-term efficacy and safety with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers
Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP
Completed positive pre-NDA meeting with FDA, confirming alignment with the agency on the expected timing, format, and content of planned NDA submission for bitopertin in EPP
Expect to submit an NDA in October 2025 under the FDA’s accelerated approval pathway based on Disc’s existing data package
Publication of the results from a preclinical study conducted in collaboration with Boston Children’s Hospital showing that, in mice, bitopertin may help prevent liver disease in EPP, in addition to ameliorating blood PPIX levels. The paper, "The GLYT1 inhibitor bitopertin mitigates erythroid PPIX production and liver disease in erythroid protoporphyria," was published in the Journal of Clinical Investigation (corresponding authors Sarah Ducamp and Paul Schmidt)
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Hosted a virtual MF Anemia KOL event on May 9, 2025, discussing DISC-0974 and its potential to play a significant role in the treatment of anemia in patients with MF
A replay of the webcast is available on the Events & Presentations page on the investor relations portion of the Company website
Presented clinical data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia demonstrating durable hematologic response at EHA (Free EHA Whitepaper) 2025
Progressing RALLY-MF Phase 2 study of DISC-0974 in patients with anemia of MF with initial data expected in Q4 2025
Exploratory cohort for patients on concomitant momelotinib or pacritinib fully enrolled, and trial protocol updated to allow patients on these therapies into the main study cohorts
Progressing Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD with multiple-dose data expected in Q4 2025
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Presented updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers providing proof of mechanism to support advancement of the program at EHA (Free EHA Whitepaper) 2025
Initiated a Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026
Corporate:

Appointed Nadim Ahmed, President and CEO of Cullinan Therapeutics, to the Company’s Board of Directors in July, bringing to the Company over 25 years of development and commercial leadership experience including multiple product launches in the hematology space
Second Quarter 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $650.0 million as of June 30, 2025, which are expected to fund operational plans into 2028.
Research and Development Expenses: R&D expenses were $46.3 million for the three months ended June 30, 2025, as compared to $23.5 million for the three months ended June 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10 million milestone upon initiation of the APOLLO study.
Selling, General and Administrative Expenses: SG&A expenses were $15.1 million for the three months ended June 30, 2025, as compared to $7.4 million for the three months ended June 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $55.2 million for the three months ended June 30, 2025, as compared to $26.4 million for the three months ended June 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

On August 7, 2025 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported financial results for the three and six months ended June 30, 2025, and provided an operating forecast and business update (Press release, Ligand, AUG 7, 2025, View Source [SID1234654989]). Ligand management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the results and answer questions.

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"We are pleased to announce an increase to our 2025 guidance reflecting the continued strength and growth of our commercial-stage royalty portfolio." said Todd Davis, CEO of Ligand. "This quarter there were several key milestones across our portfolio including the commercial launch of Zelsuvmi by our partner Pelthos and Merck’s recently announced acquisition of our partner, Verona, which is expected to further accelerate the launch trajectory of Ohtuvayre in COPD and its clinical development in other indications. These achievements reflect the significant value of our partnerships and our comprehensive asset selection process, which continue to validate our robust and differentiated royalty aggregation model."

Second Quarter 2025 Financial Results

Total revenues and other income for the second quarter of 2025 were $47.6 million, compared with $41.5 million for the same period in 2024, with the 15% increase primarily attributable to an increase in royalty revenue. Royalties for the second quarter of 2025 were $36.4 million, compared with $23.2 million for the same period in 2024, with the 57% increase primarily attributable to royalties earned on Recordati’s Qarziba, and Travere Therapeutics’ Filspari. Captisol sales were $8.3 million for the second quarter of 2025, compared with $7.5 million for the same period in 2024, with the change due to the timing of customer orders. Contract revenue and other income was $2.9 million for the second quarter of 2025, compared with $10.9 million for the same period in 2024, with the difference due to the timing of partner milestone events.

Cost of Captisol was $2.9 million and amortization of intangibles was $8.3 million for each of the second quarters of 2025 and 2024. Research and development expenses were $6.6 million for the second quarter of 2025, compared with $5.4 million for the same period in 2024, with the increase primarily attributable to expenses incurred by Pelthos in preparation for the commercial launch of Zelsuvmi. General and administrative expenses were $20.2 million for the second quarter of 2025, compared with $17.6 million for the same period in 2024, with the increase primarily attributable to employee related costs and operating costs associated with incubating the Pelthos business. Fair value adjustment to partner program derivatives was $1.3 million for the second quarter of 2025 primarily due to mark to market adjustments to certain Agenus partnered programs. In the second quarter of 2024 Ligand recorded a $26.5 million financial asset impairment tied to Takeda’s Soticlestat program which resulted from missing its Phase 3 clinical trial primary endpoint.

GAAP net income was $4.8 million, or $0.24 per diluted share for the second quarter of 2025, compared with GAAP net loss of $51.9 million, or $2.88 per share, for the same period in 2024. Core adjusted net income for the second quarter of 2025 was $32.0 million, or $1.60 per diluted share, compared to $25.8 million, or $1.40 per diluted share, for the same period in 2024. The increase in core adjusted net income was driven primarily by the

15% increase in revenue and other income. Core adjusted net income represents a non-GAAP financial measure. See the table below for a reconciliation of net income (loss) to core adjusted net income.
As of June 30, 2025, Ligand had cash, cash equivalents and short-term investments of $245.0 million, which includes $26.5 million in Viking Therapeutics common stock.

Year-to-Date Financial Results

Total revenues and other income for the six months ended June 30, 2025 were $93.0 million, compared with $72.5 million for the same period in 2024, with the 28% increase primarily attributable to an increase in royalty revenue and Captisol sales. Royalties for the six months ended June 30, 2025 were $63.9 million, compared with $42.3 million for the same period in 2024, with the 51% increase primarily attributable to royalties earned on Recordati’s Qarziba, and Travere Therapeutics’ Filspari. Captisol sales were $21.7 million for the six months ended June 30, 2025, compared with $16.7 million for the same period in 2024, with the change due to the timing of customer orders. Contract revenue and other income was $7.3 million for the six months ended June 30, 2025, compared with $13.5 million for the same period in 2024, with the difference due to the timing of partner milestone events.
Cost of Captisol was $7.8 million for the six months ended June 30, 2025, compared with $5.8 million for the same period in 2024, with the change due to an increase in Captisol sales. Amortization of intangibles was $16.5 million for the six months ended June 30, 2025, compared with $16.4 million for the same period in 2024. Research and development expenses were $56.7 million for the six months ended June 30, 2025, compared with $11.3 million for the same period in 2024, with the increase primarily attributable to a $44.3 million one-time charge in connection with Ligand’s previously announced royalty financing agreement with Castle Creek Biosciences to fund the Phase 3 clinical study of D-Fi (FCX-007), which was accounted for as a research and development funding arrangement under ASC 730-20, Research and Development Arrangements. General and administrative expenses were $39.0 million for the six months ended June 30, 2025, compared with $28.6 million for the same period in 2024, with the increase primarily attributable to employee related costs and operating costs associated with incubating the Pelthos business. Fair value adjustment to partner program derivatives was $0.8 million for the six months ended June 30, 2025 primarily due to mark to market adjustments to certain Agenus partnered programs. Financial royalty assets impairment was $26.5 million for the six months ended June 30, 2024 due to Takeda’s Soticlestat missing its Phase 3 clinical trial primary endpoint of reducing the frequency of convulsive seizures for patients with Dravet Syndrome.
GAAP net loss was $37.6 million, or $1.95 per share for the six months ended June 30, 2025, compared with GAAP net gain of $34.2 million, or $1.87 per diluted share, for the same period in 2024. Core adjusted net income for the six months ended June 30, 2025 was $58.6 million, or $2.94 per diluted share, compared to $47.6 million, or $2.61 per diluted share, for the same period in 2024. Core adjusted net income excluded gains from the sale of Viking Therapeutics common stock during the six months ended June 30, 2024. Ligand did not sell any shares of Viking Therapeutics common stock during the six months ended June 30, 2025. The increase in core adjusted net income was driven primarily by the 28% increase in revenue and other income. Core adjusted net income represents a non-GAAP financial measure. See the table below for a reconciliation of net income (loss) to core adjusted net income.

2025 Financial Guidance

Ligand is increasing its 2025 full year financial guidance. The Company now expects total revenue of $200 million to $225 million (previously $180 million to $200 million) and is raising its guidance on adjusted earnings per diluted share1 to $6.70 to $7.00 (previously $6.00 to $6.25).
Royalties are now expected to be in the range of $140 million to $150 million (previously $135 million to $140 million). Sales of Captisol are unchanged from $35 million to $40 million and contract revenue is now in the range of $25 million to $35 million (previously $10 million to $20 million).

Second Quarter 2025 and Corporate Highlights

Pelthos Therapeutics Transaction
On July 2, 2025, Ligand announced the completion of its previously announced merger between the Company’s wholly owned subsidiary, LNHC, Inc., and CHRO Merger Sub Inc., a wholly owned subsidiary of Channel Therapeutics Corporation ("Channel"). The combined company operates under the name Pelthos Therapeutics Inc. ("Pelthos") and trades on the NYSE American exchange under the ticker symbol "PTHS".
Concurrent with the merger, Pelthos raised $50.1 million of equity capital, including a private placement from a group of strategic investors led by Murchinson ("Investor Group" and together with Ligand, the "Investors"). The

Investor Group invested $32 million and Ligand invested $18 million in the combined company, respectively. The capital was invested into Pelthos’ Series A Convertible Preferred Stock ("Series A") and common stock and includes cancellation of approximately $18.8 million in bridge capital that was advanced to Pelthos by several of the Investors (including Ligand) since the beginning of 2025 to support the commercial launch of Zelsuvmi.
On July 10, 2025, Pelthos commercially launched Zelsuvmi (berdazimer) topical gel 10.3%, the first and only U.S. Food and Drug Administration (FDA) approved at-home treatment for molluscum contagiosum. Ligand earned a $5 million milestone payment from Pelthos following the commercial launch of Zelsuvmi. Ligand is also entitled to a 13% royalty on worldwide sales of Zelsuvmi, excluding Japan, and up to an additional $5 million in commercial sales milestones.

New Royalty Investment in Orchestra BioMed

On August 4, 2025, Ligand invested $25 million in strategic capital to fund Orchestra BioMed’s late-stage partnered cardiology programs with an additional $15 million to be funded, subject to certain conditions precedent, at the nine-month anniversary of the transaction closing date. Ligand’s investment included a $20 million cash payment and an additional $5 million in an equity private placement at the public offering price of $2.75 per share in Orchestra BioMed’s public offering. In exchange, Ligand will receive a low double-digit royalty on the first $100 million in commercial revenues from Orchestra’s AVIM therapy and Virtue SAB programs in all indications. Ligand will also earn a mid-single-digit royalty on annual revenues exceeding $100 million in commercial revenues from AVIM therapy in the uncontrolled hypertension and increased cardiovascular risk indication and Virtue SAB in coronary artery disease indications.

Portfolio Updates

On July 9, 2025, Merck and Verona announced a definitive agreement under which Merck, through a subsidiary, will acquire Verona for $107 per American Depository Share (ADS), each of which represents eight Verona ordinary shares, for a total transaction value of approximately $10 billion. Verona’s portfolio includes Ohtuvayre, which was approved by the FDA in June 2024 for the maintenance treatment of COPD in adult patients. Ligand receives a 3% royalty on Ohtuvayre sales.

On July 7, 2025, Agenus announced that its botensilimab and balstilimab (BOT/BAL) combination achieved a two-year survival rate of 42% along with a more mature 21-month median overall survival in an expanded cohort of 123 patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases (NLM). Agenus also confirmed that it has reached agreement with the FDA on the design of the global BATTMAN Phase 3 trial. The FDA waived the need for a BOT monotherapy arm, allowing for a simple two-arm study design.

On June 23, 2025, Palvella Therapeutics announced the full enrollment in SELVA, a Phase 3 trial of Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) for the treatment of microcystic lymphatic malformations (microcystic LMs). The Phase 3 trial enrolled 51 subjects, exceeding the original target of 40 subjects by over 25%. Top-line results from SELVA are expected in the first quarter of 2026, with a New Drug Application (NDA) submission planned for the second half of 2026.

On June 3, 2025, Agenus announced it entered into a partnership agreement with Zydus designed to accelerate clinical development, scale global manufacturing, and expand patient access to BOT/BAL. The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for an upfront consideration of $75 million. Moreover, Agenus will receive up to an additional $50 million in contingent payments triggered by BOT/BAL production orders. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialization.

On May 23, 2025, CSL Vifor announced that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that Filspari can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.

On May 16, 2025, Nuance announced top-line results from the Phase 3 ENHANCE-CHINA trial which evaluated nebulized ensifentrine (marketed as Ohtuvayre in the U.S.) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The ENHANCE-CHINA trial successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function.

On May 15, 2025, Travere announced that the FDA accepted its supplemental New Drug Application (sNDA) for traditional approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis (FSGS). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026, and has indicated that it is currently planning to hold an advisory committee meeting to discuss the application. Additionally, Travere continues to expect a PDUFA target action date of August 28, 2025 for its sNDA requesting modification of liver monitoring and removal of embryo-fetal toxicity monitoring REMS for Filspari for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

Adjusted Financial Measures

Ligand reports adjusted net income from continuing operations, adjusted net income per diluted share and adjusted earnings per diluted share in addition to, not as a substitute for, and does not consider such measures superior to, financial measures calculated in accordance with GAAP. The Company also reports a core calculation for each of the foregoing measures which excludes any realized gain from sales of Viking Therapeutics common stock. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, transaction costs, income tax effect of adjusted reconciling items and others that are listed in the itemized reconciliations between GAAP and non-GAAP adjusted financial measures included at the end of this press release. A reconciliation of forward-looking non-GAAP adjusted earnings per diluted share to the most directly comparable GAAP measures is not available without unreasonable effort, as certain items cannot be reasonably predicted because of their high variability, complexity and low visibility. Specifically, non-cash adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, share-based compensation expense and the effects of any discrete income tax items, directly impact the calculations of our adjusted earnings per diluted share, which we expect to have a significant impact on our future GAAP financial results.

Conference Call and Webcast

Ligand management will host a conference call today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 715-9871 using the conference ID 3661098. International participants outside of Canada may use the toll number +1(646) 307-1963. To participate via live or replay webcast, a link is available at www.ligand.com.

On August 7, 2025 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved ADC cancer treatments, reported financial results for the second quarter ended June 30, 2025, and provided recent corporate progress (Press release, Whitehawk Therapeutics, AUG 7, 2025, View Source [SID1234655008]).

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"We’re pleased with the progress made in Q2 to advance our ADC portfolio and remain on track to file INDs for our first two programs – HWK-007 and HWK-016 – by year-end 2025, with the third program, HWK-206, to follow in mid-2026," said Dave Lennon, PhD, President and CEO of Whitehawk Therapeutics. "We believe we are well-positioned to advance our pipeline and generate key clinical data across the portfolio with our existing cash position."

Recent Operational Highlights:

On track to bring all three assets to IND by mid-2026. IND submissions are planned by year-end 2025 for HWK-007 and HWK-016. An IND for HWK-206 is expected by mid-2026.

Focused execution and capital efficiency support anticipated runway into 2028. Based on current plans, cash position enables initial clinical data readouts across the portfolio.
Second Quarter 2025 Financial Results:

Cash, cash equivalents and short-term investments as of June 30, 2025, were $177.2 million as compared to $47.2 million as of December 31, 2024. Cash is anticipated to fund operations into 2028 based on current plans.

Net loss for the three months ended June 30, 2025, was $52.6 million as compared to $14.6 million for the three months ended June 30, 2024. This includes the remaining portion of the upfront payment of $38.0 million under the Wuxi ADC agreement.

On August 7, 2025 Silence Therapeutics plc, Nasdaq: SLN ("Silence" or "the Company"), a global clinical-stage company developing novel siRNA (short interfering RNA) therapies, reported its financial results for the second quarter ended June 30, 2025, and reviewed recent business highlights (Press release, Silence Therapeutics, AUG 7, 2025, View Source [SID1234654955]).

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"The updated data we presented at EHA (Free EHA Whitepaper) this past quarter were highly encouraging and supportive of the therapeutic potential of divesiran as a first-in-class siRNA in PV," said Craig Tooman, President and Chief Executive Officer at Silence. "The SANRECO Phase 2 trial of divesiran in PV patients continues to progress towards full enrollment this year and remains our top priority."

Rhonda Hellums, Silence’s Chief Financial Officer, said, "We are continuing to prioritize investments in key areas where we see the highest potential to deliver near term value, including ensuring the successful completion of the SANRECO Phase 2 trial enrollment by year-end. We ended the quarter with approximately $114.2 million in cash and cash equivalents and short-term investments and are reiterating our cash runway guidance into 2028."

Second Quarter 2025 & Recent Business Highlights

Divesiran for Polycythemia Vera (PV)

•
Presented updated data from the SANRECO Phase 1 study at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Annual Congress, further supporting divesiran’s compelling therapeutic profile, including:

•
Additional data showing that treatment with divesiran led to durable hematocrit control (<45%) and essentially eliminated the need for phlebotomies in the targeted population.

•
Divesiran increased hepcidin and ferritin, resulting in elevation of iron body content and improved iron deficiency.

•
Divesiran was well tolerated with no dose-limiting toxicities.

•
Exceeded 50% enrollment in the Phase 2 portion of the SANRECO trial and remain on-track to complete enrollment by year-end 2025.

Zerlasiran for Cardiovascular Disease

•
Completed core Phase 3 readiness activities, including manufacturing and supply scale up. We continue to be in dialogues with potential third-party partners for Phase 3 development of zerlasiran as well as potential future commercialization activities.

Other R&D Updates

•
Advanced extra-hepatic cell targeting of siRNA where we are seeing promising initial preclinical activity in mice models. As a result, we are prioritizing our extra-hepatic activities and have decided to pause initiating a Phase 1 study of SLN548, our wholly owned siRNA for complement-mediated diseases.

Collaborations

•
A Phase 1 study of our siRNA product candidate, SLN312, which is licensed to AstraZeneca, is ongoing.

Second Quarter 2025 Financial Highlights

•
Cash Position: Cash and cash equivalents, and short-term investments of $114.2 million as of June 30, 2025, which are expected to fund our operational plans into 2028.

•
Research & Development Expenses: R&D expenses were $17.6 million for the quarter ended June 30, 2025, as compared to $13.8 million for the quarter ended June 30, 2024. The increase in R&D expenses was primarily driven by the advancement of our clinical trials and an increase in contract manufacturing activities.

•
General & Administrative Expenses: G&A expenses were $5.1 million for the quarter ended June 30, 2025, as compared to $7.0 million for the quarter ended June 30, 2024. The decrease in G&A expenses was primarily due to a reduction in reporting and compliance requirements, as well as our efforts to increase operating efficiencies.

•
Net Loss: Net loss was $27.4 million for the quarter ended June 30, 2025, as compared to $19.8 million for the quarter ended June 30, 2024.

On August 7, 2025 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2025 (Press release, Eli Lilly, AUG 7, 2025, View Source [SID1234654974]).

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"Lilly delivered another quarter of strong performance, achieving 38% year-over-year revenue growth driven by robust sales of Zepbound and Mounjaro and sustained momentum across our key medicines," said David A. Ricks, Lilly chair and CEO. "Our pipeline continued to advance, highlighted by positive study results in oncology and cardiometabolic health—including Mounjaro’s demonstrated cardio-protective effects in patients with type 2 diabetes and heart disease and strong data for our oral incretin, orforglipron, in obesity. We also expanded manufacturing capacity to meet increasing demand and invested in key R&D initiatives to support our long-term growth."

Financial Results

$ in millions, except

per share data

Second-Quarter

2025

2024

% Change

Revenue

$ 15,557.7

$ 11,302.8

38 %

Net income – Reported

5,660.5

2,967.0

91 %

Earnings per share – Reported

6.29

3.28

92 %

Net income – Non-GAAP

5,679.3

3,541.2

60 %

Earnings per share – Non-GAAP

6.31

3.92

61 %

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

Second-Quarter Reported Results
In Q2 2025, worldwide revenue was $15.56 billion, an increase of 38% compared with Q2 2024, driven by a 42% increase in volume, partially offset by a 6% decrease due to lower realized prices. Key Products1 revenue grew to $10.40 billion in Q2 2025, led by Zepbound and Mounjaro.

Revenue in the U.S. increased 38% to $10.81 billion, driven by a 46% increase in volume, partially offset by an 8% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices was driven by Zepbound and Mounjaro.

Revenue outside the U.S. increased 37% to $4.74 billion, driven by a 35% increase in volume and to a lesser extent a 3% favorable impact on foreign exchange rates, partially offset by a 1% decrease due to lower realized prices. The volume increase outside the U.S. was driven primarily by Mounjaro.

Gross margin increased 44% to $13.11 billion in Q2 2025. Gross margin as a percent of revenue was 84.3%, an increase of 3.5 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

In Q2 2025, research and development expenses increased 23% to $3.34 billion, or 21.4% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 30% to $2.75 billion in Q2 2025, primarily driven by promotional efforts supporting ongoing and future launches.

There were no asset impairment, restructuring and other special charges in Q2 2025. In Q2 2024, there was a charge of $435.0 million, which related to litigation.

The effective tax rate was 16.5% in Q2 2025 compared with 15.6% in Q2 2024. The lower tax rate in Q2 2024 reflects the favorable tax impact of asset impairment, restructuring and other special charges in Q2 2024.

In Q2 2025, net income and earnings per share (EPS) were $5.66 billion and $6.29, respectively, compared with net income of $2.97 billion and EPS of $3.28 in Q2 2024. EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

1 The Company defines Key Products as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2025 gross margin increased 43% to $13.23 billion. Gross margin as a percent of revenue was 85.0%, an increase of 3.0 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

On a non-GAAP basis, Q2 2025 net income and EPS were $5.68 billion and $6.31, respectively, compared with net income of $3.54 billion and EPS of $3.92 in Q2 2024. Non-GAAP EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

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.

Second-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 6.29

$ 3.28

92 %

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other
special charges

—

.38

Net losses (gains) on investments in equity
securities

(.09)

.14

Earnings per share (non-GAAP)

$ 6.31

$ 3.92

61 %

Acquired IPR&D

.14

.14

— %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Second-Quarter

Year-to-Date

Selected Products

2025

2024

% Change

2025

2024

% Change

Mounjaro

$ 5,198.9

$ 3,090.8

68 %

$ 9,040.7

$ 4,897.4

85 %

Zepbound

3,381.4

1,243.2

172 %

5,693.3

1,760.6

NM

Verzenio

1,489.3

1,331.9

12 %

2,648.2

2,382.2

11 %

Total Revenue

15,557.7

11,302.8

38 %

28,286.2

20,070.8

41 %

NM – not meaningful

Mounjaro
For Q2 2025, worldwide Mounjaro revenue increased 68% to $5.20 billion. U.S. revenue was $3.30 billion, an increase of 37%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $1.90 billion compared with $677.2 million in Q2 2024, primarily driven by volume growth, including entry into new markets.

Zepbound
For Q2 2025, U.S. Zepbound revenue increased 172% to $3.38 billion, compared with $1.24 billion in Q2 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q2 2025, worldwide Verzenio revenue increased 12% to $1.49 billion. U.S. revenue was $929.0 million, an increase of 8%, driven by increased volume. Revenue outside the U.S. was $560.3 million, an increase of 19%, primarily driven by volume growth.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Donanemab receives positive opinion from the Committee for Medicinal Products
for Human Use (CHMP) in early symptomatic Alzheimer’s disease (announcement)

FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing
in early symptomatic Alzheimer’s disease (announcement).

FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support
diagnosis of Alzheimer’s disease in patients (announcement).

Lilly’s Kisunla (donanemab) receives marketing authorization in Australia for the
treatment of early symptomatic Alzheimer’s disease (announcement).

Clinical

Lilly’s oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs
in first of two pivotal Phase 3 trials in adults with obesity (announcement)

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated
cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in
patients with type 2 diabetes and heart disease (announcement)

Lilly’s Kisunla (donanemab-azbt) showed growing benefit over three years in early
symptomatic Alzheimer’s disease (announcement)

Lilly’s Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible)
BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus
Imbruvica (ibrutinib) in CLL/SLL (announcement)

Lilly’s once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety
profile consistent with daily insulin in multiple Phase 3 trials (announcement).

Lilly’s oral GLP-1, orforglipron, showed compelling efficacy and a safety profile
consistent with injectable GLP-1 medicines, in complete Phase 3 results published
in The New England Journal of Medicine (announcement).

Lilly presents first clinical data for its investigational, next-generation FRα targeting
ADC in platinum-resistant ovarian cancer at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting
(announcement).

Zepbound (tirzepatide) showed superior weight loss over Wegovy (semaglutide) in
complete SURMOUNT-5 results published in The New England Journal of Medicine
(announcement).

Other

Lilly to acquire Verve Therapeutics to advance one-time treatments for people with
high cardiovascular risk (announcement). Lilly and Verve announce expiration of
Verve tender offer (announcement).

Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through
LillyDirect Self Pay Pharmacy Solutions (announcement).

Lilly to expand its pain pipeline with acquisition of SiteOne Therapeutics
(announcement).

Lilly plans to expand Purdue University collaboration with up to a $250 million
investment to accelerate pharmaceutical innovation (announcement).

Lilly announces transitions in executive leadership (announcement).

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

2025 Financial Guidance
Full year guidance increased to the range of $60.0 billion to $62.0 billion, primarily driven by strong underlying business performance across the portfolio and foreign exchange rates.

The performance margin2 is now expected to be in the range of 42.0% and 43.5% on a reported basis and 43.0% and 44.5% on a non-GAAP basis. Both ratios reflecting the increase in revenue guidance.

Other income (expense) on a reported basis is now expected to be expense in the range of $750 million to $650 million due to a decrease in net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.

The 2025 estimated effective tax rate increased from approximately 17% on a reported basis to 19% which reflects an anticipated third quarter charge as a result of recently enacted U.S. tax legislation. The non-GAAP estimated tax rate is still expected to be approximately 17%.

Based on these changes, EPS guidance increased to the range of $20.85 to $22.10 on a reported basis and $21.75 to $23.00 on a non-GAAP basis. The company’s updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 8:30 a.m. Eastern time today and will be available for replay via the website.