On August 5, 2025 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, reported financial results for the second quarter ended June 30, 2025, including sales of TAVALISSE (fostamatinib disodium hexahydrate), GAVRETO (pralsetinib) and REZLIDHIA (olutasidenib), and recent business progress (Press release, Rigel, AUG 5, 2025, View Source [SID1234654796]).

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"Our strategic and disciplined approach to building our business has generated another strong quarter for the company. In the second quarter, we grew net product sales by 76% year-over-year, generated $59.6 million in net income and increased our cash balance to $108.4 million. This strong performance has enabled us to raise our 2025 financial guidance," said Raul Rodriguez, Rigel’s president and CEO. "We’re also excited by the continued advancement of our hematology and oncology development pipeline. In July, we completed enrollment in the dose escalation part of our ongoing Phase 1b study evaluating R289 in patients with relapsed or refractory lower-risk MDS. Later this year, we plan to share updated data from that study and initiate the dose expansion part of the study."

Second Quarter 2025 Business Update

Commercial

· Net product sales were $58.9 million, an increase of 76% from the same period of 2024.
· Rigel’s partner Kissei Pharmaceutical Co., Ltd. (Kissei) announced that its licensing partner, JW Pharmaceutical Corporation, commercially launched TAVALISSE in South Korea in early July.

Corporate

· In April, Rigel notified Eli Lilly and Company (Lilly) that it would not exercise its opt-in right related to the development and commercialization of ocadusertib (previously R552) for the treatment of non-central nervous system (CNS) diseases. As a result of the notification, Rigel recognized $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability in the second quarter. Per the agreement with Lilly, Rigel will continue to be entitled to receive milestone and tiered royalty payments on future net sales of ocadusertib and the companies’ CNS penetrant program.

Clinical Development

· Rigel continues to advance its Phase 1b clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of R2891, a novel and selective dual interleukin receptor-associated kinases 1 and 4 (IRAK1/4) inhibitor, in patients with relapsed or refractory (R/R) lower-risk myelodysplastic syndrome (MDS). Enrollment in the dose escalation part of the study was completed in July. The company expects to share updated data from the study later this year and plans to initiate the dose expansion part of the study in the second half of this year.

· Rigel presented 4 posters at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 3 posters at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress. Presentations included the final data from the GAVRETO (pralsetinib) Phase 1/2 ARROW study in RET fusion-positive non-small cell lung cancer (NSCLC) and other solid tumors, and supportive data for REZLIHDIA (olutasidenib) in patients with mutated isocitrate dehydrogenase-1 (mIDH1) relapsed or refractory (R/R) acute myeloid leukemia (AML).

Key Publications

· A paper titled "Effectiveness of Olutasidenib versus Ivosidenib in Patients With Mutated Isocitrate Dehydrogenase 1 Acute Myeloid Leukemia Who Are Relapsed or Refractory to Venetoclax: The 2102-HEM-101 Trial Versus a US Electronic Health Record-Based External Control Arm," was published in June by Catherine Lai, M.D., MPH, lead author and associate professor of Clinical Medicine, Division of Hematology-Oncology, Department of Medicine at University of Pennsylvania, in Leukemia & Lymphoma.
· A paper titled "Olutasidenib Alone or Combined with Azacitidine in Patients with Mutant IDH1 Myelodysplastic Syndrome," was published in July by Jorge E. Cortes, M.D., lead author and director, Georgia Cancer Center, Cecil F. Whitaker Jr., GRA Eminent Scholar Chair in Cancer, in Blood Advances. This is the first full report of the safety and clinical activity of an mIDH1 inhibitor plus hypomethylating agent (HMA) combination in patients with treatment-naïve and R/R MDS. The paper showed olutasidenib, alone or in combination with azacitidine, induced a high rate of clinically meaningful complete remission and hematologic improvement responses with durable remission duration, accompanied by low rates of serious treatment-emergent-adverse events in patients with intermediate-, high- or very high-risk MDS harboring mIDH1.

Second Quarter 2025 and Year-to-Date Financial Update

For the second quarter ended June 30, 2025, total revenues were $101.7 million, consisting of $58.9 million in net product sales and $42.7 million in contract revenues from collaborations. Net product sales grew 76% compared to $33.5 million in the same period of 2024. TAVALISSE net product sales were $40.1 million, growth of 52% compared to $26.4 million in the same period of 2024. GAVRETO net product sales were $11.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $7.0 million, growth of 36% compared to $5.2 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $2.0 million of revenue from Grifols S.A. (Grifols) related to delivery of drug supplies and earned royalties, $0.4 million of revenue from Kissei related to the delivery of drug supplies, and $0.2 million of revenue from Medison Pharma (Medison) related to delivery of drug supplies and earned royalties.

Total costs and expenses were $40.6 million compared to $36.4 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs and stock-based compensation expense.

Rigel reported net income of $59.6 million, or $3.33 basic and $3.28 diluted per share, compared to a net loss of $1.0 million, or $0.06 basic and diluted per share, for the same period of 2024.

For the six months ended June 30, 2025, total revenues were $155.0 million, consisting of $102.5 million in net product sales and $52.5 million in contract revenues from collaborations. Net product sales grew 72% compared to $59.5 million in the same period of 2024. TAVALISSE net product sales were $68.5 million, growth of 44% compared to $47.5 million in the same period of 2024. GAVRETO net product sales were $20.8 million compared to $1.9 million in the same period of 2024. GAVRETO became commercially available from Rigel in late June 2024. REZLIDHIA net product sales were $13.1 million, growth of 31% compared to $10.0 million in the same period of 2024. Contract revenues from collaborations primarily consisted of $40.0 million in non-cash revenue resulting from the release of the remaining cost share liability related to the agreement with Lilly for the development and commercialization of ocadusertib, $6.7 million of revenue from Grifols related to delivery of drug supplies and earned royalties, $5.1 million of revenue from Kissei related to a milestone payment and delivery of drug supplies and $0.6 million of revenue from Medison related to delivery of drug supplies and earned royalties.

Total costs and expenses were $81.1 million compared to $72.9 million for the same period of 2024. The increase in costs and expenses was mainly due to higher cost of product sales, increased research and development costs driven by the timing of clinical activities related to olutasidenib and R289, and higher personnel-related costs. These increases were partially offset by decreased stock-based compensation expense primarily from performance-based stock awards.

Rigel reported net income of $71.1 million, or $3.98 basic and $3.91 diluted per share, compared to a net loss of $9.3 million, or $0.53 basic and diluted per share, for the same period of 2024.

Cash, cash equivalents and short-term investments as of June 30, 2025 was $108.4 million, compared to $77.3 million as of December 31, 2024.

2025 Outlook

Rigel is updating its 2025 total revenue guidance to approximately $270 to $280 million, an increase from the previous range of approximately $200 to $210 million, which includes:

· Net product sales of approximately $210 to $220 million, an increase from the previous range of approximately $185 to $192 million.
· Contract revenues from collaborations of approximately $60 million, an increase from the previous range of approximately $15 to $18 million.

The company anticipates it will report positive net income for the full year 2025, while funding existing and new clinical development programs.

The above total revenues and contract revenues from collaborations are inclusive of $40 million in non-cash contract revenue related to Rigel’s agreement with Lilly.

Conference Call and Webcast with Slides Today at 4:30pm Eastern Time

Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-3088 (domestic) or (201) 389-0927 (international). The conference call will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About ITP

In patients with immune thrombocytopenia (ITP), the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. Patients suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About NSCLC

It is estimated that over 226,000 adults in the U.S. will be diagnosed with lung cancer in 2025. Lung cancer is the leading cause of cancer death in the U.S, with non-small cell lung cancer (NSCLC) being the most common type accounting for 85-90% of all lung cancer diagnoses.2 RET fusions are implicated in approximately 1-2% of patients with NSCLC.3

About AML

Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 22,010 new cases in the United States, most in adults, in 2025.4

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.5,6 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.7 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need.

About TAVALISSE

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE.

About GAVRETO

GAVRETO is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

On August 5, 2025 Recursion (Nasdaq: RXRX), a leading clinical stage TechBio company decoding biology to radically improve lives, reported business updates and financial results for its second quarter ended June 30, 2025 (Press release, Recursion Pharmaceuticals, AUG 5, 2025, View Source [SID1234654795]).

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Recursion will host a (L)earnings Call on August 5, 2025 at 8:00 am ET / 6:00 am MT / 1:00 pm BST from Recursion’s X (formerly Twitter), LinkedIn, and YouTube accounts giving analysts, investors, and the public the opportunity to ask questions of the company by submitting questions here: View Source

"The power of our platform not only allows us to discover and develop potential new medicines, but also gives us insights on patient populations to target that would be challenging using traditional methods," said Chris Gibson, Co-Founder and CEO of Recursion. "In discovery, we’re deploying advanced models like Boltz-2 to rapidly design ligands for high-value targets. State of the art platform capabilities helped us drive our fourth partnered discovery milestone with Sanofi this quarter, reflecting tangible momentum across our joint pipeline. We are leveraging these and other improvements to the Recursion OS to not only accelerate and improve our funnel of new programs, but also execution of later stage programs in our pipeline like RBM39 and CDK7."

Summary of Business Highlights

Portfolio – Internal and Partnered Programs

"REC-1245, our potential first-in-class RBM39 degrader, was identified using phenomap-derived insight, and mimics CDK12 loss to induce replication stress and suppress DDR pathways without CDK12 related toxicities. Early data show strong activity in tumors characterized by replication stress and DNA repair vulnerabilities. Our DAHLIA trial is now enrolling select tumor types to identify responsive populations. For REC-617, our CDK7 inhibitor, we leveraged multi-omic and real world patient data and causal AI modeling to select platinum-resistant ovarian cancer as the first combination cohort," said Najat Khan, PhD, Chief R&D Officer and Chief Commercial Officer of Recursion.

Internal Pipeline Updates:
•REC-1245 (RBM39): Recursion provided updates on the biomarker strategy and patient population currently enrolling in the ongoing Phase 1/2 DAHLIA study.
◦About REC-1245
▪Potential first-in-class oral RBM39 degrader that selectively impairs alternative splicing to silence multiple DDR pathways, leading to high replication stress.
▪Characterized to selectively mimic the phenotype associated with CDK12 loss of function using Recursion’s AI-powered maps of human biology.
◦Update on target patient population
▪Early preclinical data shows REC-1245 reduces viability in tumors characterized by replication stress and DNA repair vulnerabilities (DDR defects) across multiple solid tumor types, including MSI-H/dMMR, HRR altered cancers, and other tumors.
▪Multi‑omic profiling underway to refine the molecular signature of sensitivity.
◦Additional DAHLIA trial details

▪Monotherapy dose-escalation of Phase 1/2 DAHLIA trial in patients with advanced solid tumors ongoing.
▪Early safety and PK data from the Phase 1 dose-escalation portion on track for 1H26.
•REC-617 (CDK7): Recursion initiated a combination dose escalation portion of the ELUCIDATE Phase 1/2 trial in 1H25.
◦About REC-617
▪Orally bioavailable, highly potent, and selective CDK7 inhibitor with best-in-class potential.
▪Precision-designed using Recursion’s generative AI and active learning platform to optimize for non-covalent binding and ADME/PK, potentially delivering a broader therapeutic window, reduced off-target effects, and enhanced absorption.
▪Early Phase 1/2 results demonstrated promising safety and efficacy signals, including a durable partial response in a late-stage metastatic ovarian cancer patient and stable disease across four other patients with solid tumors (e.g. CRC, NSCLC).
◦Update on target patient population
▪Based on early clinical, preclinical, and causal AI modeling data, Recursion selected ovarian cancer as the initial combination dose expansion cohort.
◦Additional ELUCIDATE combination trial details
▪REC-617 in combination with standards of care in 2L+ platinum-resistant ovarian cancer population. Enrollment activities have been initiated.
▪Additional tumor types and therapies for single-arm expansion cohorts under evaluation.
▪Additional data from monotherapy dose-escalation on-track for 2H25.
•REC-102 (ENPP1): Acquired full rights to REC-102, Recursion’s ENPP1 inhibitor for the treatment of hypophosphatasia (HPP), from its joint venture with Rallybio.
◦REC-102 is the first potential oral disease-modifying treatment for HPP, a rare and debilitating genetic disorder with limited treatment options.
◦Additional preclinical data from the REC-102 program will be presented at the 2025 American Society for Bone and Mineral Research (ASMBR), being held in Seattle, WA.
▪A poster titled Amelioration of osteomalacia in late-onset HPP mice via pharmacological inhibition of ENPP1 is scheduled for presentation on September 6, 2025 between 2:00 PM – 3:30 PM PT, during the Basic and Translational session.
◦Phase 1 initiation remains on-track for 2H26.

Upcoming milestones:
•REC-4881 (MEK1/2): Additional data in FAP from TUPELO expected in 2H25.
•REC-617 (CDK7): Additional monotherapy data expected in 2H25.

•REC-7735 (PI3Kα H1047R): Preclinical studies ongoing with development candidate expected in 2H25.
•REC-1245 (RBM39): Early Phase 1 safety and PK monotherapy data expected in 1H26.
•REC-3565 (MALT1): Early Phase 1 safety and PK monotherapy data expected in 2H26.
•REC-102 (ENPP1): Phase 1 initiation expected in 2H26.
•Potential for over $100 million in partnership milestones by the end of 2026.
◦Several programs are advancing towards potential development candidate designation over the next 12-15 months.
◦Multiple neuroscience target validation programs advancing by leveraging the RecursionOS.
Partnered Discovery Updates:
•Sanofi: Recursion and Sanofi continue to advance multi-target collaboration for up to 15 best-in-class or first-in-class programs across oncology and immunology, with $130 million in upfront and milestone payments achieved to date. Each program has the potential for over $300 million in milestone payments.
◦In 2Q, achieved a $7 million milestone payment for an immunology program. Under the collaboration, this is the fourth partnered program reaching a significant discovery milestone in 18 months.
◦Sanofi is now leveraging combined RecursionOS 2.0, including phenomics, to identify new program opportunities.
◦Several programs are advancing towards potential development candidate designation over the next 12-15 months.
•Roche and Genentech: Recursion continues to make meaningful progress on both building additional neuromaps and driving target validation and small molecule programs in a single GI oncology indication.
◦Neuro: To date, the collaboration has built a whole-genome knockout phenomap derived from over one trillion iPSC-derived neural cells, alongside around 5,000 transcriptomes representing approximately 171 TB of data.
▪Potential neuroscience targets have been identified for validation from the map, and today multiple novel target validation programs are advancing leveraging the RecursionOS and Genentech’s biological expertise.
▪Building additional neuromaps, including multi-modal maps, combining Roche and Genentech’s expertise in single cell screens with Recursion’s and Genentech’s multi-omic machine learning capabilities.
◦GI-Oncology: To date, Recursion has generated all whole genome scale and small molecule GI-oncology specific phenomaps contemplated in the partnership, from which both novel target and small molecule programs can be surfaced.
◦One optioned program continues to advance toward lead series.
◦Focused on advancing multiple novel target and/or compound programs.
•Bayer: Recursion and Bayer have nominated multiple early discovery precision oncology programs against previously "undruggable" targets. Work is underway to advance multiple programs to lead series milestone decisions.
•Merck KgAa, Darmstadt, Germany: Collaboration ongoing to identify first-in-class and best-in-class targets.

Recursion OS 2.0: The platform is continuing to drive program development with applications across biology, chemistry and clinical development.
•Actively expanding the Virtual Cell to understand and predict cellular behavior across a wider range of biology.
◦Boltz-2 open source model released with MIT and Nvidia to commoditize state of the art performance for binding affinity prediction approaching the accuracy of physics-based free energy perturbation (FEP) calculations while being over 1,000 times faster and less computationally expensive. The open source tool has been downloaded by over 40,000 unique users to date.
◦Incorporating diverse cell types beyond HUVEC and disease areas beyond oncology, to discover more novel biology and new medicines.
•Recursion continues to expand its ClinTech platform, integrating high-quality, linked patient datasets like Tempus, HealthVerity, and Helix to strengthen programs, bolster preclinical and early clinical data to select patients (e.g., for REC-617), and optimize recruitment.

Second Quarter 2025 Financial Results

•Cash Position: Cash, cash equivalents and restricted cash were $533.8 million as of June 30, 2025 compared to $603.0 million as of December 31, 2024. Based on current operating plans, the Company believes that its expected cash runway will extend into the fourth quarter of 2027.
•Revenue: Total revenue, consisting primarily of revenue from collaboration agreements, was $19.2 million for the second quarter of 2025, compared to $14.4 million for the second quarter of 2024.
•Research and Development Expenses: Research and development expenses were $128.6 million for the second quarter of 2025, compared to $73.9 million for the second quarter of 2024. The increase was primarily driven by the Company’s agreement with Tempus as well as its business combination with Exscientia in November 2024. This includes recognition of $22.7 million in non-cash expenses for use of Tempus’ patient-centric multimodal oncology data under the companies’ ongoing collaboration.

•General and Administrative Expenses: General and administrative expenses were $46.7 million for the second quarter of 2025 compared to $31.8 million for the second quarter of 2024. The increase compared to the prior period was primarily due to the inclusion of G&A expenses from the business combination with Exscientia.
•Net Loss: Net loss was $171.9 million for the second quarter of 2025, compared to a net loss of $97.5 million for the second quarter of 2024.
•Operational cash flows: Net cash used in operating activities was $208.4 million for the six months ended June 30, 2025, compared to net cash used in operating activities of $184.5 million for the six months ended June 30, 2024. The increase in cash used in operating activities was primarily driven by the inclusion of Exscientia’s operations, for which the business combination with Recursion closed in November 2024.This was partially offset by cash inflows from partnerships and operational tax rebates totaling $7.0 million and $28.6 million respectively for the first three and six months of 2025. No cash inflows from partnerships or operational tax rebates were recorded during the six months ended June 30, 2024. In association with the restructuring activities announced in June 2025, the Company expects to incur costs totalling $9.3 million, of which $3.9 million has been paid in the second quarter of 2025. Recursion expects to incur all of these expenses in the year ending December 31, 2025.

On August 5, 2025 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported solid results for Q2 2025 that exceeded the outlook, and increased the full-year 2025 outlook for net sales growth while reaffirming the adjusted diluted earnings per share (EPS) target that was raised earlier in the year (Press release, Qiagen, AUG 5, 2025, View Source [SID1234654794]).

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Net sales rose 7% to $534 million compared to Q2 2024, with 6% growth at constant exchange rates (CER) exceeding the outlook for at least 5% CER growth. Core sales, which exclude discontinued products such as NeuMoDx and Dialunox, also rose 6% CER. The adjusted operating income margin increased 1.5 percentage points to 29.9% of sales, driven by efficiency gains across QIAGEN while absorbing the impact of new tariffs. Adjusted diluted EPS was $0.60, with results of $0.62 CER exceeding the outlook for at least $0.60 CER.

Based on the solid performance in H1 2025, and taking into account current macroeconomic trends (including U.S. and China import tariffs), QIAGEN has increased the FY 2025 net sales outlook to 4-5% CER growth (prior about 4% CER growth) and 5-6% CER core sales growth (prior about 5% CER growth), and reaffirmed the adjusted diluted EPS target of about $2.35 CER, which was increased by seven cents in April 2025, and for an adjusted operating income margin of about 30%.

"Our teams achieved another solid performance in Q2 2025, with results ahead of our outlook for both sales and adjusted earnings. QIAstat-Dx and QuantiFERON posted strong double-digit growth, while QIAcuity and QIAGEN Digital Insights continued to expand their contributions. Sample technologies saw good demand for automated consumables, and we are preparing to launch three important new instruments starting in late 2025 to support future growth. These results reflect focused execution, strategic investments and disciplined management. We are on track to achieve our upgraded 2025 targets and deliver solid profitable growth," said Thierry Bernard, CEO of QIAGEN.

"QIAGEN delivered strong financial results in Q2 2025, with the adjusted operating margin rising to 29.9 percent as we progress toward our 2028 goal for at least 31% faster than planned. Efficiency gains and disciplined cost management are supporting reinvestments in key initiatives while maintaining strong cash flow. As part of our capital allocation strategy, we have now returned over $350 million to shareholders in 2025 through the synthetic share repurchase and our first-ever cash dividend. We remain focused on funding innovation and creating value through an ongoing balanced and disciplined approach," said Roland Sackers, CFO of QIAGEN.

Please find the full press release incl. tables as a PDF for download at the top of this page.

Investor presentation and conference call

A conference call is scheduled for Wednesday, August 6, 2025, at 15:30 Frankfurt Time / 14:30 London Time / 9:30 New York Time. A live audio webcast will be available in the Investor Relations section of the QIAGEN website (www.qiagen.com), with a recording accessible after the event. The accompanying presentation will be published in advance under "Events and Presentations" in the same website section.

Use of adjusted results

QIAGEN reports adjusted results and constant exchange rate (CER) measures, along with other non-GAAP financial metrics, to provide deeper insight into its business performance. These include core sales (excluding discontinued products), adjusted gross margin and profit, adjusted operating income and expenses, adjusted operating income margin, adjusted net income, adjusted income before taxes, adjusted diluted EPS, adjusted EBITDA, adjusted tax rate, and free cash flow. Free cash flow is calculated as cash flow from operating activities less capital expenditures for property, plant and equipment. Adjusted results are non-GAAP measures that QIAGEN views as complementary to GAAP-reported results. They exclude items considered outside of ongoing core operations, subject to significant period-to-period fluctuation, or that reduce comparability with competitors and historical performance. QIAGEN also uses these non-GAAP and constant currency measures internally for planning, forecasting, reporting, and employee compensation purposes. These metrics support consistent comparison of current and past performance, which has historically been presented on an adjusted basis.

On August 5, 2025 Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2025 and reaffirmed its 2025 Revenue guidance while raising guidance(1) for Adjusted(2) diluted EPS (Press release, Pfizer, AUG 5, 2025, View Source [SID1234654793]).

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:

"Pfizer had another strong quarter of focused execution and we’re pleased with our progress in advancing our R&D pipeline, driving our commercial performance and expanding our margins. We continue to strengthen our company for the future and we’re confident in our ability to create further value for patients and our shareholders."
David Denton, CFO and EVP of Pfizer:
"Our robust second-quarter Revenue and EPS performance demonstrates our continued focus on commercial execution and operational efficiency. We raised our full-year 2025 Adjusted diluted EPS guidance, demonstrating confidence in our ability to execute against our strategic priorities and deliver strong results for shareholders."
OVERALL RESULTS
■Second-Quarter 2025 Revenues of $14.7 Billion, Representing 10% Year-over-Year Operational Growth
■Second-Quarter 2025 Reported(3) Diluted EPS of $0.51, and Adjusted(2) Diluted EPS of $0.78
■Reaffirms Full-Year 2025 Revenue Guidance(1) in a Range of $61.0 to $64.0 Billion
■Raises Full-Year 2025 Adjusted(2) Diluted EPS Guidance(1) by $0.10 to a Range of $2.90 to $3.10, which Absorbs a One-Time Impact of Approximately $0.20 Related to 3SBio Transaction
■On Track to Deliver Approximately $7.2 Billion in Overall Anticipated Net Cost Savings from Previously Announced Cost Improvement Initiatives(4) by End of 2027, Driving Productivity Gains and Operating Margin Expansion

Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period changes that exclude the impact of foreign exchange rates(5).
Results for the second quarter and first six months of 2025 and 2024(6) are summarized below.
($ in millions, except per share amounts)
Second-Quarter Six Months
2025 2024
% Change
2025 2024
% Change
Revenues $ 14,653 $ 13,283 10% $ 28,367 $ 28,162 1%
Reported(3) Net Income
2,910 41 * 5,877 3,156 86%
Reported(3) Diluted EPS
0.51 0.01 * 1.03 0.55 86%
Adjusted(2) Income
4,434 3,400 30% 9,671 8,074 20%
Adjusted(2) Diluted EPS
0.78 0.60 30% 1.69 1.42 20%
* Indicates calculation not meaningful or results are greater than 100%.

REVENUES
($ in millions) Second-Quarter Six Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 14,305 $ 12,991 10% 10% $ 27,746 $ 27,595 1% 1%
Pfizer CentreOne (PC1) 328 278 18% 18% 585 535 9% 10%
Pfizer Ignite 20 15 38% 38% 37 32 16% 16%
TOTAL REVENUES $ 14,653 $ 13,283 10% 10% $ 28,367 $ 28,162 1% 2%
2025 FINANCIAL GUIDANCE(1)
■Reaffirms full-year 2025 Revenue guidance and raises Adjusted(2) diluted EPS guidance(1) by $0.10 at the midpoint to a range of $2.90 to $3.10.
■The updated 2025 Adjusted(2) diluted EPS guidance takes into consideration our strong year-to-date performance, continued confidence in our business, a favorable impact from foreign exchange, progress with ongoing cost improvement initiatives, and improvement in our effective tax rate.
–Includes a one-time $1.35 billion Acquired In-Process R&D charge related to the licensing agreement with 3SBio, Inc. that will be recorded in the third quarter of 2025 with an expected unfavorable impact of approximately $0.20.
■The company’s guidance absorbs the impact of the currently imposed tariffs from China, Canada, and Mexico, as well as potential price changes this year based on the letter received on July 31, 2025 from President Trump.
Revenues
$61.0 to $64.0 billion
Adjusted(2) SI&A Expenses
$13.1 to $14.1 billion
(previously $13.3 to $14.3 billion)
Adjusted(2) R&D Expenses
$10.4 to $11.4 billion
(previously $10.7 to $11.7 billion)
Effective Tax Rate on Adjusted(2) Income
Approximately 13.0%
(previously approximately 15.0%)
Adjusted(2) Diluted EPS
$2.90 to $3.10
(previously $2.80 to $3.00)

CAPITAL ALLOCATION
During the first six months of 2025, Pfizer deployed its capital in a variety of ways, which primarily included:
▪Reinvesting capital into initiatives intended to enhance the future growth prospects of the company, including:
•$4.7 billion invested in internal research and development projects, and
•Approximately $150 million invested in business development transactions. Separately, the completed 3SBio transaction will be recorded in third-quarter 2025.
▪Returning capital directly to shareholders through $4.9 billion of cash dividends, or $0.86 per share of common stock.

No share repurchases have been completed to date in 2025. As of August 5, 2025, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2025. The company expects to continue to de-lever in a prudent manner in order to maintain a balanced capital allocation strategy. This includes maintaining the flexibility to deploy capital towards potential value-creating business development transactions and the potential to return capital to shareholders through share repurchases.
Diluted weighted-average shares outstanding of 5,706 million and 5,696 million were used to calculate Reported(3) and Adjusted(2) diluted EPS for second-quarter 2025 and 2024, respectively.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2025 vs. Second-Quarter 2024)
Second-quarter 2025 revenues totaled $14.7 billion, an increase of $1.4 billion, or 10%, compared to the prior-year quarter, reflecting an operational increase of $1.3 billion, or 10%, as well as a favorable impact of foreign exchange of $22 million. The operational increase was primarily driven by an increase in revenues for the Vyndaqel family, Comirnaty, Paxlovid, Padcev, Eliquis and several other products across categories despite the unfavorable impact of higher manufacturer discounts resulting from the Inflation Reduction Act (IRA) Medicare Part D Redesign.
Second-quarter 2025 operational revenue growth was driven primarily by:
▪Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 21% operationally, driven largely by strong demand with continuing uptake in patient diagnosis primarily in the U.S. and certain international developed markets, partially offset by lower net price in the U.S. mostly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign;
▪Comirnaty globally, up 95% operationally, driven primarily by higher net revenues in the U.S. partially due to higher market share, as well as higher contractual deliveries in certain international markets;
▪Paxlovid globally, up 71% operationally, driven primarily by higher net price in the U.S. following the transition from the U.S. government agreement as well as a favorable adjustment of rebate accruals related to prior periods, partially offset by lower COVID-19 infections across the U.S. and certain international markets as well as lower international government purchases;
▪Padcev globally, up 38% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC), as well as a one-time favorable impact associated with the transition to a wholesaler distribution model in the U.S.;
▪Eliquis globally, up 6% operationally, driven primarily by higher demand globally; partially offset by lower net price in the U.S., including the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, and price erosion in certain international markets;
▪Abrysvo globally, up 155% (or up $86 million) operationally, driven primarily by higher U.S. revenues from both a favorable net sales adjustment and higher demand for the maternal indication that more than offset ower vaccination rates for the older adult indication following an updated Advisory Committee on Immunization Practices (ACIP) recommendation; as well as launch uptake for both the adult and maternal indications in certain international markets; and
▪Lorbrena globally, up 48% operationally, driven primarily by increased patient share in the first-line ALK-positive metastatic non-small cell lung cancer (ALK+ mNSCLC) treatment setting in the U.S., China, and certain other international markets, partially offset by lower net price in the U.S. mainly due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign;
partially offset primarily by lower revenues for:
▪Ibrance globally, down 8% operationally, driven primarily by lower net price in the U.S. largely due to the impact of higher manufacturer discounts resulting from the IRA Medicare Part D Redesign, as well as generic entry and timing of shipments in certain international markets.
GAAP Reported(3) Statement of Operations Highlights
SELECTED REPORTED(3) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2025 2024 % Change 2025 2024 % Change
Total Oper. Total Oper.
Cost of Sales(3)
$ 3,778 $ 3,300 15% 13% $ 6,624 $ 6,679 (1%) 1%
Percent of Revenues
25.8 % 24.8 % N/A N/A 23.4 % 23.7 % N/A N/A
SI&A Expenses(3)
3,415 3,717 (8%) (8%) 6,446 7,212 (11%) (10%)
R&D Expenses(3)
2,482 2,696 (8%) (8%) 4,685 5,189 (10%) (10%)
Acquired IPR&D Expenses(3)
2 6 (68%) (68%) 11 6 72% 72%
Other (Income)/Deductions—net(3)
739 1,107 (33%) (33%) 1,692 1,787 (5%) —
Effective Tax Rate on Reported(3) Income
4.6 % 130.2 % (0.8 %) 4.8%

Second-quarter 2025 Cost of Sales(3) as a percentage of revenues increased by 0.9 percentage points compared to the prior-year quarter, driven primarily by the non-recurrence of a favorable revision to accrued royalties recorded in the second quarter of 2024, partially offset by lower amortization from the step-up of acquired inventory.
Second-quarter 2025 SI&A Expenses(3) decreased 8% operationally compared with the prior-year quarter, primarily reflecting focused investments and ongoing productivity improvements that drove a decrease in marketing and promotional spend for various products and lower spending in corporate enabling functions.
Second-quarter 2025 R&D Expenses(3) decreased 8% operationally compared with the prior-year quarter, driven primarily by a net decrease in spending due to pipeline focus and optimization, as well as lower compensation-related expenses.

On August 5, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the second quarter ended June 30, 2025, and recent accomplishments of its "Win-in-MRD" strategy (Press release, Personalis, AUG 5, 2025, View Source [SID1234654792]):

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Second Quarter 2025 and Recent Business Highlights

•
Clinical Adoption Acceleration: Delivered 3,478 clinical tests in the second quarter, a 59% sequential increase over Q1 2025, demonstrating accelerating physician adoption of the NeXT Personal platform

•
Commercial Partnership Expansion: Broadened the strategic collaboration with Tempus AI, Inc. (Tempus) to add colorectal cancer, a major new indication, to the exclusive commercialization agreement, positioning Personalis to win in this attractive market

•
World-Class Clinical Evidence Generation: Presented pivotal data at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, including results from the PREDICT and SCANDARE studies showing NeXT Personal’s ability to predict therapy response in breast cancer. Notably, nearly half of all positive detections were found in the ultra-sensitive range

•
Clinical Utility Demonstration: Additional data presented at ASCO (Free ASCO Whitepaper) from the Phase 3 CALLA trial in partnership with AstraZeneca showed NeXT Personal detected cervical cancer progression up to 16 months earlier than standard imaging

"The results of our "Win-in-MRD" strategy are clear, with an impressive 59% sequential growth in our clinical test volume," said Chris Hall, Chief Executive Officer and President of Personalis. "This powerful adoption trend is fueled by a continuous flow of compelling clinical data, like our recent landmark ASCO (Free ASCO Whitepaper) presentations, which prove the unique value of our ultra-sensitive MRD platform in guiding patient care. Steady recognition and growth in the use of our platform continues to support our strategy as we navigate the temporary headwinds in the biopharma sector which have affected our current results. Our fundamental growth engine is accelerating, keeping us firmly on track to achieve our most critical strategic objectives for 2025, including securing Medicare coverage for two indications."

Second Quarter 2025 Financial Results Compared with 2024

•
Revenue of $17.2 million for the second quarter of 2025 compared with $22.6 million, a decrease of 24%, primarily due to the expected decline of $5.6 million in revenue from Natera, and a decrease in revenue from pharma tests and services, and other customers of $2.1 million, partially offset by an increase in population sequencing revenue of $2.0 million

•
Pharma tests and services, and other customers of $11.1 million for the second quarter of 2025 compared with $13.2 million, a decrease of 16%

•
Population sequencing of $3.3 million for the second quarter of 2025 compared with $1.3 million, an increase of 158%

•
Gross margin of 27.6% for the second quarter of 2025 compared with 35.6%, a decrease of 8.0% primarily due to lower revenue volume, customer mix, and increased unreimbursed clinical test costs

•
Net loss of $20.1 million, and net loss per share of $0.23 based on a weighted-average basic and diluted share count of 88.5 million in the second quarter 2025, compared with a net loss of $12.8 million, and net loss per share of $0.24 based on a weighted-average basic and diluted share count of 52.4 million

•
Cash, cash equivalents, and short-term investments of $173.2 million as of June 30, 2025; cash usage of $13.2 million from operations and capital equipment additions in the second quarter of 2025

Third Quarter and Full Year 2025 Outlook

Personalis expects the following for the third quarter of 2025:

•
Total company revenue to be in the range of $12.0 to $14.0 million

•
Revenue from pharma tests and services, and all other customers to be in the range of $11.0 to $13.0 million

•
Revenue from population sequencing and enterprise sales of approximately $1.0 million

Personalis now expects the following for the full year of 2025 (updated guidance):

•
Total company revenue in the range of $70 to $80 million (reduced from $80 to $90 million)

•
Revenue from pharma tests and services, and all other customers in the range of $52 to $58 million (reduced from $62 to $64 million); the lower range is due to variability with biopharma projects and timing of sample receipts

•
Revenue from population sequencing and enterprise sales in the range of $15 to $16 million

•
Revenue from clinical tests reimbursed in the range of $3 to $6 million (narrowed range from $3 to $10 million)

•
Gross margin in the range of 22% to 24%, which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical use of NeXT Personal ahead of reimbursement

•
Net loss of approximately $85 million (increased from $83 million)

•
Cash usage of approximately $75 million, which is an increase from the $47 million used in the full year of 2024 primarily due to investments in the next phase of our "Win-in-MRD" strategy, including growing test volume, expanding clinical evidence generation, and investing in commercial capabilities to drive growth

Webcast and Conference Call Information

Personalis will host a conference call to discuss the second quarter financial results, as well as plans for 2025, after market close on Tuesday, August 5, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.