RenovoRx to Highlight TAMP™ Platform at JonesTrading Virtual Key Opinion Leader Webinar on the Evolving Pancreatic Cancer Landscape, August 13th

On August 4, 2026 RenovoRx, Inc. ("RenovoRx" or "the Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a patented, FDA-cleared drug-delivery device, reported it will participate in a JonesTrading webinar with oncology key opinion leaders (KOLs) and Shaun Bagai, Chief Executive Officer of RenovoRx, on August 13, 2026 at 1:30 p.m. ET.

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The webinar, The Evolving Pancreatic Cancer Landscape: The Role of RenovoRx’s TAMP Platform and Emerging Clinical Advances, will be moderated by Justin Walsh, Equity Research Analyst covering the healthcare sector at JonesTrading. He will be joined by Dae Won Kim, MD, Medical Oncologist in Gastrointestinal Oncology at Moffitt Cancer Center, Ravi Shridhar, MD, PhD, Theranostic Program Director in the Department of Radiation Oncology at AdventHealth Cancer Institute, and Mr. Bagai.

Clinical Topics

● The exciting and rapidly evolving pancreatic cancer treatment landscape.

● RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) platform, enabled by the RenovoCath device, and its potential to deliver various existing and new chemotherapies locally rather than systemically.

● The ongoing Phase III TIGeR-PaC clinical trial, which is evaluating intra-arterial gemcitabine delivered via RenovoCath, as a potential treatment for locally advanced pancreatic cancer.

● Clinical experience integrating TAMP chemotherapy delivery via RenovoCath as a commercially available stand-alone medical device product into medical practice.

RenovoRx Commercial and Financial Topics

● Promising commercial launch of RenovoCath as a stand-alone device within its FDA-cleared uses, with growing revenues and a pathway for continued revenue expansion.

● Increasing the number of active commercial cancer center customers and their utilization of TAMP and RenovoCath to drive revenue and reduce the Company’s cash burn.

Webinar Details:

Title: The Evolving Pancreatic Cancer Landscape: The Role of RenovoRx’s TAMP Platform and Emerging Clinical Advances

Date: Thursday, August 13, 2026

Time: 1:30 p.m. ET

Speakers: Dae Won Kim, MD, Moffitt Cancer Center,
Ravi Shridhar, MD, PhD, AdventHealth Cancer Institute, and
Shaun Bagai, Chief Executive Officer, RenovoRx

Moderator: Justin Walsh, Equity Research Analyst, Healthcare, JonesTrading

Webcast: View Source

For interested individuals unable to join the webinar, a replay of the webcast will be available at View Source.

(Press release, Renovorx, AUG 4, 2026, View Source [SID1234669666])

Precigen Reports Second Quarter 2026 Financial Results Highlighted by Accelerating PAPZIMEOS Revenue Growth

On August 4, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported second quarter 2026 financial results and business updates.

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"We delivered a historic second quarter, with the rapid adoption of PAPZIMEOS demonstrating the strength of our groundbreaking science and innovative commercial strategy," said Helen Sabzevari, PhD, President and CEO of Precigen. "This momentum provides a strong foundation for our next phase of growth as we work to expand PAPZIMEOS globally and into the pediatric population. PAPZIMEOS demonstrates the AdenoVerse platform’s ability to target HPV-associated diseases. We are building on that validated capability by advancing PRGN-2009 in HPV-driven cancers, with a pipeline update expected by year-end. With growing commercial momentum, a validated platform, and multiple opportunities ahead, we believe Precigen is well positioned to deliver sustained value for patients across various indications, the broader healthcare community, and our shareholders."

"We continue to see the key elements of the PAPZIMEOS commercial launch drive revenue growth: 100% field engagement with our initial target accounts, active patient and HCP campaigns, a permanent J-code supporting access and site activations, payer coverage across nearly all insured US lives, growing physician consensus reflected in a RRP position paper, and continued patient hub enrollments," said Phil Tennant, Chief Commercial Officer of Precigen. "This progress translated into strong quarterly revenue growth and increasing adoption across major medical centers and community practices as PAPZIMEOS becomes established as a new standard of care for adults with RRP. We remain focused on converting demand into treated patients and further expanding access to PAPZIMEOS across the RRP community."

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS: First-line Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis (RRP). PAPZIMEOS has been approved by the US Food and Drug Administration (FDA) for the treatment of adults with RRP.

· Broad US adoption: Well over 500 patients have registered through Precigen’s patient hub, with additional patients outside of the hub being identified and receiving treatment as institutions support patient access directly and independently.
· Market exclusivity: PAPZIMEOS was granted seven years of market exclusivity by the FDA, providing long-term protection against prospective competition. PAPZIMEOS remains the first and only approved therapy for adults with RRP and the only treatment designed to target the underlying cause of the disease.
· Broad payer coverage: PAPZIMEOS has payer coverage across approximately 315 million US lives through private health plans, Medicare, and Medicaid, representing nearly 100% of insured lives nationwide.
· Permanent J-code: The Centers for Medicare and Medicaid Services assigned permanent J-code, J3404, to PAPZIMEOS, effective April 1, 2026. The J-code provides a standard pathway for reimbursement, helps institutions process claims more efficiently, and reduces uncertainty for sites that are still building PAPZIMEOS into their workflows.
· First-line standard of care: An expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading RRP physicians recommended PAPZIMEOS as the first-line standard of care for adults with RRP in the United States.
· Redosing study enrolling patients: The Company’s open-label study to evaluate redosing efficacy of zopapogene imadenovec in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).
· MAA under review by the EMA: The European Medicines Agency (EMA) has validated and is reviewing the Marketing Authorization Application (MAA) submitted in November 2025 for zopapogene imadenovec for the treatment of adults with RRP. PAPZIMEOS has been granted orphan drug designation from the European Commission.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
· A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
· The Company plans to provide an update on progress across the AdenoVerse portfolio, including PRGN-2009, by the end of the year.

FINANCIAL RESULTS

"We are thrilled to report that Precigen achieved profitability in the second quarter, marking a significant milestone for the company. Net income was driven by strong PAPZIMEOS revenue of $53.1 million. As we progress through the third quarter of 2026, we are seeing continued growth in PAPZIMEOS demand," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "Based upon our current revenue trajectory and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026."

Second Quarter 2026 Financial Results Compared to Prior Year Period

Total revenues were $55.0 million for the three months ended June 30, 2026, an increase of $54.1 million compared to the three months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the three months ended June 30, 2026 were $53.1 million.

Cost of products and services increased by $1.7 million, compared to the three months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

R&D expenses decreased by $4.2 million, compared to the three months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.

SG&A expenses increased by $6.1 million, compared to the three months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

In the three months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the second quarter of 2026.

Total other expense, net was $2.6 million for the three months ended June 30, 2026 compared to other income, net of $5.1 million for the three months ended June 30, 2025, a change of $7.7 million. This change was primarily attributable to the absence of a $4.5 million gain related to the decrease in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change primarily relates to an increase of $3.0 million in interest expense related to long term debt that originated in the third quarter of 2025.

Net income was $20.1 million, or $0.06 per basic and $0.05 per diluted share for the three months ended June 30, 2026, compared to a net loss of $26.6 million, or $(0.09) per basic and diluted share, for the three months ended June 30, 2025.

First Six Months 2026 Financial Results Compared to Prior Year Period

Total revenues were $78.2 million for the six months ended June 30, 2026, an increase of $76.0 million compared to the six months ended June 30, 2025. The significant increase in total revenues was primarily due to the recording of commercial sales of PAPZIMEOS. Revenues related to the sale of PAPZIMEOS for the six months ended June 30, 2026 were $74.7 million.

Cost of products and services increased by $3.2 million, compared to the six months ended June 30, 2025, almost entirely due to costs related to the recording of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Prior to regulatory approval, costs associated with the production of PAPZIMEOS were expensed as research and development in accordance with the Company’s accounting policy. Upon FDA approval and the commencement of commercial sales, these costs are now capitalized as inventory and recognized in cost of product and services as product is sold.

R&D expenses decreased by $9.0 million, compared to the six months ended June 30, 2025, primarily due to the change in the accounting treatment of PAPZIMEOS manufacturing costs. The Company expects that R&D expenses will increase as the year progresses.

SG&A expenses increased by $14.8 million, compared to the six months ended June 30, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025. The higher expenses reflect increased costs to support commercialization, expanded marketing and promotional activities to drive product awareness and adoption, and increased personnel costs, including stock compensation expense.

In the six months ended June 30, 2025, the Company recorded $3.9 million in impairment related to its Exemplar reporting unit with no comparable charge in the six months ended June 30, 2026.

Total other expense, net decreased by $21.9 million, compared to the six months ended June 30, 2025. This decrease was primarily attributable to the absence of a $28.0 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $5.9 million in interest expense related to long-term debt that was entered into in the third quarter of 2025.

Net income was $12.1 million, or $0.03 per basic and diluted share for the six months ended June 30, 2026, compared to a net loss of $80.8 million, or $(0.27) per basic and diluted share, for the six months ended June 30, 2025.

(Press release, Precigen, AUG 4, 2026, View Source [SID1234669665])

Pfizer Reports Second-Quarter Results And Raises Midpoint of 2026 Revenue Guidance

On August 4, 2026 Pfizer Inc. (NYSE: PFE) reported financial results for the second quarter of 2026 and raised its full-year 2026 Revenue guidance by $500 million at the midpoint while reaffirming guidance(2) for Adjusted(3) diluted EPS, which absorbs an impact of approximately $0.10 related to the Innovent Biologics, Inc. transaction.

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EXECUTIVE COMMENTARY

Dr. Albert Bourla, Chairman and CEO of Pfizer:

"Pfizer had another strong quarter, delivering on our financial commitments and advancing our strategy. Our launched and acquired products(1) performed well, our obesity program is advancing with meaningful momentum and our oncology portfolio remains a source of strength. I am confident we will create substantial future value for patients and shareholders."
Cecile Guegan, Incoming Interim CFO and EVP of Pfizer:
"Our second-quarter results are attributable to our solid commercial performance globally as well as our ongoing focus on operational efficiency. This quarter, I’m particularly pleased with the 18% year-over-year operational revenue growth from our launched and acquired products(1). Our updated full-year 2026 guidance reflects the continued strength of and confidence in our business."
OVERALL RESULTS
■Second-Quarter 2026 Revenues of $15.0 Billion, Representing 1% Year-over-Year Operational Growth
–Excluding Contributions from Comirnaty and Paxlovid, Revenues Grew 5% Operationally
–Revenues of Launched and Acquired Products(1) Grew 18% Operationally
■Second-Quarter 2026 Reported(4) Loss Per Share of $(0.04), and Adjusted(3) Diluted EPS of $0.77
–Reported(4) Loss Per Share Reflects $4.3 Billion in Non-Cash Intangible Asset Impairments
■Announces Additional Anticipated Productivity Enhancement Savings of $2.5 Billion(5) Associated with Ongoing Initiatives, Expected to be Realized From 2027 Through 2029
■Raises Full-Year 2026 Revenue Guidance(2) by $500 Million at the Midpoint to a Range of $60.5 to $62.5 Billion
■Reaffirms Full-Year 2026 Adjusted(3) Diluted EPS Guidance in a Range of $2.80 to $3.00, which Absorbs an Impact of Approximately $0.10 Related to the Innovent Biologics, Inc. Transaction

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(6).
Results for the second quarter and first six months of 2026 and 2025(7) are summarized below.
($ in millions, except per share amounts)
Second-Quarter Six Months
2026 2025
% Change
2026 2025
% Change
Revenues $ 15,034 $ 14,653 3% $ 29,484 $ 28,367 4%
Reported(4) Net Income/(Loss)
(248) 2,910 * 2,440 5,877 (58%)
Reported(4) Diluted EPS/(LPS)
(0.04) 0.51 * 0.43 1.03 (59%)
Adjusted(3) Income
4,440 4,434 —% 8,730 9,671 (10%)
Adjusted(3) Diluted EPS
0.77 0.78 —% 1.52 1.69 (10%)
* Indicates calculation not meaningful or results are greater than 100%.

REVENUES
($ in millions) Second-Quarter Six Months
2026 2025 % Change 2026 2025 % Change
Total Oper. Total Oper.
Global Biopharmaceuticals Business (Biopharma) $ 14,661 $ 14,305 2% 1% $ 28,822 $ 27,746 4% 2%
Pfizer CentreOne
373 348 7% 5% 662 622 7% 3%
TOTAL REVENUES $ 15,034 $ 14,653 3% 1% $ 29,484 $ 28,367 4% 2%

2026 FINANCIAL GUIDANCE(2)
■Raises full-year 2026 Revenue guidance(2) by $500 million at the midpoint to a range of $60.5 to $62.5 billion, from $59.5 to $62.5 billion previously.
–The 2026 full-year Revenue guidance reflects better than expected performance of the non-COVID products by approximately $1.5 billion and the revised revenue expectation for our COVID-19 products, down to approximately $4 billion from approximately $5 billion previously.
■Reaffirms full-year 2026 Adjusted(3) diluted EPS guidance(2) in a range of $2.80 to $3.00.
–The 2026 Adjusted(3) diluted EPS guidance takes into consideration our strong year-to-date performance, continued confidence in our business and progress with ongoing cost improvement initiatives.
–Absorbs a $650 million Acquired In-Process R&D charge related to the completed licensing agreement with Innovent Biologics, Inc. that will be recorded in the third quarter of 2026 with an expected unfavorable impact of approximately $0.10.
Previous 2026 Financial Guidance Anticipated Impact of Non COVID-19 Products Anticipated Impact of COVID-19 Products Anticipated Impact of Innovent Biologics, Inc. Transaction
Revised 2026 Financial Guidance(2)
Revenues ($ in billions)
Midpoint
$59.5 to $62.5
$61.0
+$1.5
-$1.0
-
$60.5 to $62.5
$61.5
Adjusted(3) SI&A Expenses ($ in billions)
$12.5 to $13.5
$12.5 to $13.5
Adjusted(3) R&D Expenses ($ in billions)
$10.5 to $11.5
$10.5 to $11.5
Effective Tax Rate on Adjusted(3) Income
~15.0%
~15.0%
Adjusted(3) Diluted EPS
$2.80 to $3.00
+$0.10
-$0.10
$2.80 to $3.00

CAPITAL ALLOCATION
During the first six months of 2026, 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:
–$5.3 billion invested in internal research and development projects, and
–Approximately $170 million invested in business development transactions. In addition, on July 10, 2026, we completed the Innovent Biologics, Inc. transaction, which will be recorded in the third quarter of 2026.
■Returning capital directly to shareholders through $4.9 billion of cash dividends, or $0.86 per share of common stock.
Our capital allocation framework is designed to enhance long-term shareholder value, and is based on three core pillars: (i) reinvesting in the business, including maintaining the flexibility to deploy capital towards potential value-creating business development transactions, (ii) maintaining and, over the long term, growing our dividend, and (iii) in the future, the potential to resume the return of capital to shareholders through value-enhancing share repurchases after de-levering our balance sheet. The company expects to continue to de-lever over the longer term in a prudent manner in order to maintain a balanced capital allocation strategy.
No share repurchases have been completed to date in 2026. As of August 4, 2026, Pfizer’s remaining share repurchase authorization is $3.3 billion. Current financial guidance does not anticipate any share repurchases in 2026.
For the second-quarter of 2026, basic weighted-average shares outstanding of 5,699 million were used to calculate Reported(4) LPS and diluted weighted-average shares outstanding of 5,734 million were used to calculate Adjusted(3) diluted EPS. Diluted weighted-average shares outstanding of 5,706 million were used to calculate Reported(4) and Adjusted(3) diluted EPS for second-quarter 2025.
QUARTERLY FINANCIAL HIGHLIGHTS (Second-Quarter 2026 vs. Second-Quarter 2025)
Second-quarter 2026 revenues totaled $15.0 billion, an increase of $381 million, or 3%, compared to the prior-year quarter, reflecting an operational increase of $164 million, or 1%, and a favorable impact of foreign exchange of $217 million. The operational increase was driven by an increase in revenues for Eliquis, Padcev, the Vyndaqel family, Lorbrena and several other products across categories, partially offset by a decline in COVID-19 product revenues and several other products across categories. Excluding contributions from Comirnaty and Paxlovid, revenues for the second quarter grew 5% operationally. Additionally, second-quarter revenues of our Launched and Acquired Products(1) grew 18% operationally.
Second-quarter 2026 operational revenue growth was driven primarily by:
■Eliquis globally, up 19% operationally, driven primarily by higher net price in the U.S. primarily due to pricing dynamics, including lower rebates and channel mix favorability, as well as higher demand globally; partially offset by declines due to generic entry and price erosion in certain international markets;
■Padcev globally, up 23% operationally, driven primarily by increased market share in first-line locally advanced or metastatic urothelial cancer (la/mUC), as well as launch uptake in the cisplatin-ineligible indication for muscle-invasive bladder cancer; partially offset by a one-time favorable impact associated with transition to a wholesaler distribution model in the U.S. in the prior-year quarter;
■Vyndaqel family (Vyndaqel, Vyndamax, Vynmac) globally, up 8% operationally. International growth was primarily driven by strong demand with continuing uptake in patient diagnosis across international markets, as well as improved access in certain international markets. In the U.S., growth was primarily driven by continued market expansion, partially offset by net price erosion as a result of new payer contracts; and
■Lorbrena globally, up 37% 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 primarily by lower revenues for:
■Paxlovid globally, down 95% operationally, driven primarily by lower COVID-19 infections across the U.S. and international markets and lower government purchases in certain international markets; and
■Comirnaty globally, down 34% operationally, driven primarily by a lower favorable adjustment to the returns provision, as well as lower utilization in the U.S. primarily resulting from a narrower recommendation for vaccination.
GAAP Reported(4) Statement of Operations Highlights
SELECTED REPORTED(4) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2026 2025 % Change 2026 2025 % Change
Total Oper. Total Oper.
Cost of Sales(4)
$ 4,092 $ 3,778 8% 7% $ 7,640 $ 6,624 15% 10%
Percent of Revenues
27.2 % 25.8 % N/A N/A 25.9 % 23.4 % N/A N/A
SI&A Expenses(4)
3,411 3,415 —% (1%) 6,372 6,446 (1%) (3%)
R&D Expenses(4)
2,809 2,482 13% 13% 5,299 4,685 13% 12%
Acquired IPR&D Expenses(4)
16 2 * * 153 11 * *
Other (Income)/Deductions—net(4)
3,716 739 * * 4,577 1,692 * *
Effective Tax Rate on Reported(4) Income/(Loss)
62.4 % 4.6 % 2.1 % (0.8%)
* Indicates calculation not meaningful or results are greater than 100%.

Second-quarter 2026 Cost of Sales(4) as a percentage of revenues increased by 1.4 percentage points compared to the prior-year quarter, primarily driven by an unfavorable change in sales mix and higher amortization of the fair value step-up of acquired inventory, primarily driven by the Oxbryta impairment.
Second-quarter 2026 SI&A Expenses(4) decreased 1% operationally compared to the prior-year quarter, primarily reflecting lower spending in corporate enabling functions, largely offset by an increase in implementation costs associated with our cost realignment program.

Second-quarter 2026 R&D Expenses(4) increased 13% operationally compared to the prior-year quarter, driven primarily by an increase in spending in certain oncology and obesity product candidates, which was anticipated.
Other (income)/deductions—net(4) was $3.7 billion for the second quarter of 2026. The increase compared to the prior-year quarter is primarily the result of intangible asset impairment charges, and to a lesser extent, charges for certain legal matters, partially offset by a net gain in 2026 from the sale of our previous investment in ViiV Healthcare Limited.
Pfizer’s higher effective tax rate on Reported(4) loss for the second quarter of 2026 reflects a tax benefit on the pre-tax loss resulting from changes in jurisdictional mix of earnings, primarily due to intangible asset impairments.

Adjusted(3) Statement of Operations Highlights
SELECTED ADJUSTED(3) COSTS AND EXPENSES
($ in millions) Second-Quarter Six Months
2026 2025 % Change 2026 2025 % Change
Total Oper. Total Oper.
Adjusted(3) Cost of Sales
$ 3,656 $ 3,503 4% 3% $ 7,061 $ 6,096 16% 10%
Percent of Revenues 24.3 % 23.9 % N/A N/A 23.9 % 21.5 % N/A N/A
Adjusted(3) SI&A Expenses
3,344 3,395 (1%) (3%) 6,259 6,404 (2%) (4%)
Adjusted(3) R&D Expenses
2,730 2,438 12% 12% 5,164 4,611 12% 11%
Acquired IPR&D Expenses(3)
16 2 * * 153 11 * *
Adjusted(3) Other (Income)/Deductions—net
108 186 (42%) (35%) 496 431 15% 11%
Effective Tax Rate on Adjusted(3) Income
14.1%
13.2 % 15.5 % 10.3 %
* Indicates calculation not meaningful or results are greater than 100%.

See the reconciliations of certain Reported(4) to non-GAAP Adjusted(3) financial measures and associated footnotes in the financial tables section of this press release.
RECENT NOTABLE DEVELOPMENTS (Since May 5, 2026)
Product Developments
Product/Project Milestone Recent Development Link
Braftovi
(encorafenib) Phase 3 Results
May 2026. Announced detailed progression-free survival (PFS) and overall survival (OS) results from Cohort 3, a randomized cohort of the Phase 3 BREAKWATER trial, evaluating Braftovi in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin, and irinotecan) versus FOLFIRI with or without bevacizumab in patients with previously untreated mCRC with a BRAF V600E mutation. Results for the key secondary endpoint of PFS by blinded independent central review showed a clinically meaningful and statistically significant 56% reduction in the risk of disease progression or death was observed for patients treated with the Braftovi combination regimen versus the comparator (Hazard Ratio [HR] of 0.44; 95% Confidence Interval [CI], 0.27–0.70; p=0.0002). Updated OS, a descriptive secondary endpoint, showed a 44% reduction in the risk of death for patients treated with the Braftovi combination regimen versus the comparator (HR of 0.56; 95% CI, 0.34–0.94) with a median follow-up of approximately 20 months for both arms. The safety profile of Braftovi in combination with cetuximab and FOLFIRI in the Cohort 3 analysis continued to be consistent with the known safety profile of each respective agent in the regimen, and no new safety signals were identified.
Full Release

Comirnaty (COVID-19 Vaccine, mRNA) Regulatory
July 2026. Pfizer and BioNTech announced the European Commission (EC) granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase.
Full Release
Regulatory
May 2026. Pfizer and BioNTech announced the European Commission approved an update to the marketing authorization for the companies’ COVID-19 vaccine for children aged 6 months through 4 years. With this authorization, the vaccine will be administered as a 10-μg dose for all children aged 6 months through 11 years and reduces the primary vaccination series in this age group to two doses.
Full Release
Hympavzi (marstacimab) Regulatory
June 2026. Announced the U.S. Food and Drug Administration (FDA) approved an expanded indication for Hympavzi to include the treatment of patients with hemophilia A or B 12 years and older with inhibitors and pediatric patients (ages 6 to 11 years) with or without inhibitors. Hympavzi is now indicated in the U.S. for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 6 years of age and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) with or without factor IX inhibitors.
Full Release
Regulatory
May 2026. Announced the European Commission granted marketing authorization to expand the approved indication for Hympavzi to include patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors. Hympavzi is the only once-weekly subcutaneous treatment approved in the European Union for both people living with hemophilia A or B, with or without inhibitors.
Full Release
Ibrance (palbociclib) Regulatory
June 2026. Announced FDA approval of Ibrance in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC) following induction treatment based on data from the collaborative Phase 3 PATINA trial. With this approval, Ibrance is the first and only CDK 4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status.
Full Release

Litfulo (ritlecitinib) Phase 3 Results
July 2026. Announced positive topline results from two Phase 3 trials evaluating the efficacy and safety of Litfulo once daily in patients with both active and stable nonsegmental vitiligo (NSV) and who had a broad range of disease severity. The TRANQUILLO study included patients aged 12 years and older, while TRANQUILLO 2 enrolled adults only. Across the studies, both the 50 and 100 milligram doses of Litfulo delivered significant, clinically meaningful improvements over placebo on co-primary endpoints for the facial and total body Vitiligo Area Scoring Index, or VASI. The safety profile of Litfulo in NSV was consistent with the established safety profile in alopecia areata. No new safety signals were observed. Based on these results, Pfizer intends to submit global regulatory filings for Litfulo as a potential new oral systemic therapy for NSV for adults.
Full Release
Lorbrena (lorlatinib) Phase 3 7-Year Analysis
May 2026. Announced unprecedented seven-year follow-up results from the Phase 3 CROWN trial evaluating Lorbrena versus Xalkori in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). At seven years, patients treated with Lorbrena had a 55% likelihood of remaining alive without disease progression (95% CI, 46-63) compared to 3% (95% CI, 1-8) in the Xalkori treatment arm. An updated analysis at seven years of median follow-up showed that investigator-assessed median PFS had not been reached with Lorbrena, with an estimated HR of 0.19 (95% CI, 0.13-0.26), representing an 81% reduction in the risk of disease progression or death compared to Xalkori. The safety profiles of Lorbrena and Xalkori were consistent with previous findings, with no new safety signals observed.
Full Release

Padcev (enfortumab vedotin) Regulatory
July 2026. Pfizer and Astellas Pharma Inc. announced FDA approval of Padcev plus pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph as neoadjuvant and adjuvant (before and after surgery) treatment for adult patients with muscle-invasive bladder cancer (MIBC) regardless of cisplatin eligibility. Approval was based on results from the pivotal Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15) and marks the first platinum-free regimen approved for adult patients with MIBC, regardless of cisplatin eligibility.
Full Release
Talzenna (talazoparib) Regulatory
July 2026. Announced the FDA accepted for priority review a supplemental New Drug Application (sNDA) for Talzenna in combination with Xtandi which aims to expand use to men with homologous recombination repair (HRR) gene-altered metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC). The application is supported by data from the TALAPRO-3 study. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026.
Full Release
Phase 3 Results
May 2026. Announced detailed results from the pivotal, investigational Phase 3 TALAPRO-3 study of Talzenna in combination with Xtandi in men with HRR gene-mutated mCSPC, also known as mHSPC. Talzenna plus Xtandi demonstrated a 52% reduction in the risk of radiographic progression or death compared to placebo plus Xtandi (HR of 0.48; 95% CI, 0.36–0.65; p ˂ 0.0001). At three years, radiographic progression-free survival (rPFS) rates were estimated at 77% in patients treated with Talzenna plus Xtandi versus 56% in patients treated with placebo plus Xtandi. The safety profile of Talzenna plus Xtandi in TALAPRO-3 was consistent with the known profiles of each medicine, and no new safety signals were identified.
Full Release

Pipeline Developments
A comprehensive update of Pfizer’s development pipeline was published today and is now available at www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration.

Product/Project Milestone Recent Development Link
berobenatide
(PF’3944)
Phase 2 Results
June 2026. Presented detailed results from multiple Phase 2b studies of berobenatide (PF’3944), an investigational, potential first-in-class monthly GLP-1 receptor agonist (GLP-1 RA) peptide. Across both weekly and monthly dosing in participants with obesity or overweight, with and without type 2 diabetes, the data from the Phase 2b VESPER-1, 2 and 3 studies provided proof of concept for berobenatide as a potential first-in-class monthly GLP-1 RA peptide that can deliver competitive weight loss; showed favorable tolerability for berobenatide, including low gastrointestinal adverse events and discontinuations despite rapid dose escalation and no allowed step-down; and highlighted the potential for monthly delivery in a patient-friendly presentation with a very low 0.5 mL injection volume that provides convenience and scalability advantages.
These data support Pfizer’s plans to advance 10 Phase 3 studies for berobenatide in 2026 for chronic weight management and obesity-related comorbidities including knee osteoarthritis and obstructive sleep apnea, as part of a broader program of 20+ obesity trials.
Full Release
PF-07872412 (25-valent pneumococcal conjugate vaccine candidate) Phase 2 Results
May 2026. Announced data from the Phase 2 study (NCT06524414) evaluating the safety, tolerability and immunogenicity of a four-dose series of an investigational 25-valent pneumococcal conjugate vaccine candidate PF-07872412 (25vPnC) in infants compared to four doses of Prevnar 20 at months 2, 4, 6 and 12-15. The Phase 2 data demonstrated robust immunogenicity with 25vPnC, including enhanced response against serotype 3, alongside expanded protection across 25 serotypes and was well-tolerated with no safety concerns identified. Based on the results from the Phase 2 program and discussions with regulatory authorities, a pivotal Phase 3 pediatric program began in May 2026. Also announced a fifth generation 35-valent vaccine adult candidate is expected to enter clinical development by the end of 2026, pending alignment with regulatory authorities.
Full Release
sigvotatug vedotin Phase 3 Results
June 2026. Announced topline results from the Phase 3 SigVie-002 study (previously known as Be6A Lung-01) evaluating sigvotatug vedotin, an investigational, potential first-in-class integrin beta-6 (IB6) directed antibody-drug conjugate (ADC). The study enrolled adults with locally advanced, unresectable or metastatic non-squamous NSCLC who had received one or more lines of prior therapy. In the overall population, sigvotatug vedotin did not show a statistically significant improvement in the primary endpoint of OS compared to docetaxel. The safety profile of sigvotatug vedotin was manageable and consistent with prior studies. In patients who received only one prior line of systemic therapy, which represents two-thirds of the study population, a stronger trend was observed for OS and PFS for sigvotatug vedotin over docetaxel. In the exploratory analysis, no clear IB6 expression-response relationship was observed. Pfizer is evaluating sigvotatug vedotin in several ongoing studies across multiple stages and patient populations in NSCLC and other solid tumors.
Full Release

Topic Recent Development Link
Expansion of Ongoing Cost Savings Programs(5)
Announced at Q2-2026 Earnings. Pfizer announced $1.0 billion of additional anticipated net cost savings associated with its ongoing cost realignment program (the "Realigning Our Cost Base Program") driven by further productivity enhancements from technology and simplification efforts across our commercial, R&D and enabling functions. These additional net savings are expected to further reduce costs in SI&A and be realized from 2027 through 2029. Pfizer expects one-time costs to achieve the additional savings to be incurred through 2029 and to total approximately $2.0 billion, primarily representing cash expenditures for digital enablement, implementation and severance. Pfizer previously announced that it remains on track to deliver anticipated net cost savings of approximately $5.7 billion by the end of 2026 and, with the additional anticipated savings, Pfizer now expects total net cost savings of approximately $6.7 billion from the Realigning our Cost Base Program through 2029.
The estimate of costs that Pfizer expects to incur and savings that Pfizer expects to achieve, and the timing thereof, are subject to a number of assumptions and actual results may differ from current expectations. Pfizer may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Realigning our Cost Base Program.
N/A
Announced at Q2-2026 Earnings. Pfizer announced the next phase of its multi-year program designed to reduce our cost of goods sold. This phase of the cost reduction program (the "program") is focused on network structure changes, product portfolio enhancements and additional operational efficiencies and is expected to deliver additional anticipated savings of approximately $1.5 billion through 2029, some of which is expected to begin being realized in 2027. The one-time costs to achieve the savings associated with this phase of the program are expected to be approximately $4.0 billion, with approximately 60% of non-cash expenditures for accelerated depreciation and asset write-downs and 40% of cash expenditures for severance, implementation and exit costs. The costs to achieve these savings are expected to be incurred through 2029. Pfizer previously announced that it remains on track to deliver anticipated net cost savings from the first phase of this program of approximately $1.5 billion by the end of 2027 and, with the additional targeted savings from this phase, Pfizer now expects total net cost savings of approximately $3.0 billion from this program through 2029.
The estimate of costs that Pfizer expects to incur and savings that Pfizer expects to achieve, and the timing thereof, are subject to a number of assumptions and actual results may differ from current expectations. Pfizer may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the program as well as for potential future phases.
N/A

– 11 –

Topic Recent Development Link
Business Development
May 2026. Pfizer and Innovent Biologics, Inc. announced the companies have entered into a strategic global licensing and collaboration agreement for the research and development of 12 promising new early-stage and de novo cancer medicines. The partnership includes licensing, co-development, and co-commercialization opportunities across a diverse portfolio of antibody-drug conjugates (ADCs) with novel differentiated payloads and multi-specific antibodies with differentiated immune-engaging features and unique designs. Under the terms of the agreement, Innovent Biologics, Inc. received a $650 million upfront payment and is eligible for up to $9.85 billion in development, regulatory and commercial milestone payments. Additionally, Innovent Biologics, Inc. will receive up to double-digit royalties on sales of each licensed product if approved. For the four programs to be co-developed and co-commercialized by Pfizer and Innovent Biologics, Inc., the two companies will share the profits in the U.S., the U.K. and the European Union. The transaction closed on July 10, 2026.
Full Release
Finance Leadership
June 2026. Announced Dave Denton will step down from his current role as Chief Financial Officer and leave the company on August 15 and named Cecile Guegan, currently Senior Vice President, Finance, Global Biopharmaceutical Business, as Interim Chief Financial Officer, effective August 16, while Pfizer conducts a comprehensive internal and external search for its next Chief Financial Officer.
Full Release

PFIZER TO HOST CONFERENCE CALL
Pfizer will host a live conference call and webcast today, August 4, 2026, at 10:00 AM EDT. To access the live conference call, the second-quarter 2026 earnings presentation, and the accompanying prepared remarks from management, visit our website at pfizer.com/investors.
You can also listen to the conference call by dialing either 800-456-4352 in the U.S. and Canada or 785-424-1086 outside of the U.S. and Canada. The passcode is "29301".
The transcript and webcast replay of the call will be made available on our website at pfizer.com/investors within 24 hours after the end of the live conference call and will be accessible for at least 90 days.

(Press release, Pfizer, AUG 4, 2026, View Source [SID1234669664])

Personalis Reports Second Quarter Results and Recent Highlights

On August 4, 2026 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial and operational results for the second quarter ended June 30, 2026, and highlighted recent business accomplishments.

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Second Quarter and Recent Strategic and Operational Highlights


Secured Medicare Coverage for IO Monitoring: Received Medicare coverage approval for NeXT Personal for immunotherapy monitoring for patients with late-stage solid tumors.

Secured Medicare Coverage for Neoadjuvant Therapy Monitoring for Breast Cancer: Received Medicare coverage approval for NeXT Personal for monitoring treatment response to neoadjuvant therapy (NAT) in patients diagnosed with Stage II-III Triple-Negative Breast Cancer (TNBC) or HER2-positive (HER2+) breast cancer.

Presented Compelling Colorectal Cancer Recurrence Detection: The prospective VICTORI study led by the University of British Columbia showed NeXT Personal detected 100% of all patient relapses, including all distant metastases in historically difficult-to-detect regions like the lung. Notably, just four weeks after surgery, NeXT Personal detected over 80% of patients who later relapsed, providing clinicians with an early signal of cancer to inform treatment pathways.

Highlighted Importance of Sub-10 ppm Sensitivity in Lung Cancer: Approximately 21% of pre-operative adenocarcinoma and 18% of post-operative landmark detections in the TRACERx study were below 10 ppm—thresholds frequently missed by less sensitive assays. Patients detected in this range experienced a three-fold increased risk of recurrence compared to patients with undetectable ctDNA, potentially enabling much earlier clinical intervention.

Second Quarter 2026 Financial Results Compared with Second Quarter 2025


Quarterly Revenue: Total revenue of $22.4 million compared with $17.2 million, a 30% increase, primarily driven by higher pharma testing services and growth in clinical tests as a result of recent expanded Medicare reimbursement coverages.

Clinical Revenue: Clinical test revenue of $2.6 million compared with $0.5 million, a 442% increase resulting from a full quarter of covered lung cancer testing revenue and also, the expansion of Medicare coverage for IO therapy monitoring received in the second quarter; delivered 10,384 clinical tests compared with 3,478, representing a 199% increase.

Core Revenue Streams: Revenue from pharma testing services and all other customers totaled $16.8 million compared with $11.1 million, a 51% increase. Revenue from population sequencing (the VA MVP) totaled $3.0 million compared with $3.3 million, a 9% decrease.


Strong Cash Position: Ended the quarter with approximately $212.7 million in cash, cash equivalents, and short-term investments.
CEO Commentary

"We delivered another exceptional quarter of growth, highlighted by a 199% year-over-year and 33% sequential increase in clinical volume, with more than 1,400 physicians ordering NeXT Personal," said Chris Hall, Chief Executive Officer of Personalis. "Our second quarter accomplishments further demonstrate that execution of our ‘Win-in-MRD’ strategy to establish NeXT Personal as the new standard for detecting cancer recurrence early has been effective. Looking into the second half of the year, we remain excited about the scale, complementary capabilities and resources that combining with Tempus gives us to accelerate innovation and deliver even greater value to patients, clinicians and biopharma partners and we expect to continue building our body of evidence to support reimbursement expansion into new indications, as well as continue to grow adoption of Next Personal by the clinical community. We remain firmly on-track to achieve more than a 500% increase in our clinical revenue over last year."

Full Year 2026 Outlook

As a result of the announcement on July 20, 2026 that Personalis and Tempus AI, Inc. have entered into an Agreement and Plan of Merger, Personalis will no longer provide financial guidance or conduct a quarterly earnings conference call.

(Press release, Personalis, AUG 4, 2026, View Source [SID1234669663])

Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2026 Financial Results; Highlights Key Regulatory and Clinical Milestones Across Broad, Diverse Pipeline

On August 4, 2026 Merck & Co., Inc., Rahway, N.J., USA (NYSE: MRK), known as MSD outside the United States and Canada, reported financial results for the second quarter of 2026.

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"We continued to make substantial progress across our business this quarter, driven by strong execution and growing contributions from new product launches," said Robert M. Davis, chairman and chief executive officer. "The FDA approval of LIPFENDRA is an exciting moment for our company and for patients, marking the latest milestone in our nearly 70-year legacy in cardiovascular disease. Together with key regulatory and clinical advances across oncology, HIV and immunology, this achievement reflects the strength of our pipeline and portfolio transformation as we bring forward the next wave of innovation. I am confident in the ongoing execution of our strategy as we deliver for patients and further enhance our long-term growth trajectory."

Financial Summary

$ in millions, except EPS amounts

Second Quarter

2026

2025

Change

Change Ex-

Exchange

Sales

$16,607

$15,806

5%

4%

GAAP net (loss) income2

(1,335)

4,427

N/M

N/M

Non-GAAP net (loss) income that excludes certain items2,3*

(330)

5,366

N/M

N/M

GAAP EPS

(0.54)

1.76

N/M

N/M

Non-GAAP EPS that excludes certain items3*

(0.13)

2.13

N/M

N/M

*Refer to table on page 7.

N/M – Not meaningful

For the second quarter of 2026, Generally Accepted Accounting Principles (GAAP) loss / earnings per share (EPS) assuming dilution was a loss per share of $0.54 and non-GAAP loss per share was $0.13. Both the GAAP and non-GAAP loss per share were due to a charge for the acquisition of Terns Pharmaceuticals, Inc. (Terns) of $2.31 per share. Both GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment related to a license agreement with Jiangsu Hengrui Pharmaceutical Co., Ltd. (Hengrui Pharma).

Non-GAAP EPS excludes acquisition- and divestiture-related costs and costs related to restructuring programs, as well as income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit reserve adjustments.

Year-to-date results can be found in the attached tables.

Second-Quarter Sales Performance
The following table reflects sales of the Company’s top products and significant performance drivers.

Second Quarter

$ in millions

2026

2025

Change

Change Ex-Exchange

Commentary

Total Sales

$16,607

$15,806

5%

4%

Pharmaceutical

14,760

14,050

5%

4%

Increase primarily driven by growth in oncology as well as cardiometabolic and respiratory, partially offset by a decline in diabetes.

KEYTRUDA/
KEYTRUDA QLEX

8,366

7,956

5%

4%

Growth primarily driven by strong global uptake in earlier-stage indications, including triple-negative breast cancer (TNBC), cervical cancer, head and neck cancer and bladder cancer, as well as higher global demand in metastatic indications, including urothelial cancer. Sales of KEYTRUDA QLEX were $463 million.

GARDASIL/
GARDASIL 9

1,169

1,126

4%

3%

Increase primarily due to higher demand in Asia Pacific and Europe, as well as favorable timing of tenders in Europe, partially offset by lower demand in certain other international markets.

PROQUAD, M-M-R II and VARIVAX

592

609

-3%

-3%

Decrease primarily reflects lower demand in the U.S., partially offset by higher net pricing in the U.S., higher demand in Europe and favorable private-sector purchasing patterns for M-M-R II in the U.S.

WINREVAIR

588

336

75%

75%

Growth primarily reflects continued uptake in the U.S. and early launch uptake in certain international markets, particularly in Japan and Europe.

BRIDION

497

461

8%

8%

Growth primarily due to higher demand and net pricing in the U.S.

JANUVIA/JANUMET

429

623

-31%

-31%

Decline primarily due to lower demand and net pricing in the U.S. due to competition, as well as lower demand in China and most other international markets due to ongoing generic competition.

Lynparza*

365

370

-1%

-2%

Relatively flat compared with prior year.

PREVYMIS

295

228

29%

28%

Increase primarily due to higher demand in the U.S. and certain European markets, reflecting in part the launch of new indications.

Lenvima*

283

265

7%

6%

Growth primarily due to higher demand in the U.S., partially offset by lower net pricing.

WELIREG

271

162

67%

67%

Growth primarily driven by higher demand in the U.S. and continued launch uptake in several international markets, particularly in Japan, as well as favorable wholesaler purchasing patterns in the U.S.

OHTUVAYRE

204

Product obtained as part of the Company’s October 2025 acquisition of Verona Pharma plc. Includes a benefit from the timing of specialty pharmacy purchases in the U.S.

CAPVAXIVE

184

129

42%

40%

Increase primarily driven by launch uptake in several international markets, particularly in Asia Pacific and Europe, as well as in the U.S.

VAXNEUVANCE

148

229

-35%

-36%

Decline primarily due to favorable prior period public-sector activity in the U.S., which increased sales in that period, as well as lower demand in the U.S. and in most international markets in the current period due to competitive pressure.

LAGEVRIO

5

83

-95%

-95%

Decline largely due to lower demand in Japan and the U.S.

Animal Health

1,775

1,646

8%

5%

Growth attributable to both Livestock and Companion Animal product portfolios.

Livestock

1,041

961

8%

6%

Growth primarily driven by higher demand for ruminant and poultry products.

Companion Animal

734

685

7%

5%

Growth primarily due to new product launches. Sales of BRAVECTO line of products were $359 million and $335 million in the current and prior-year quarters, respectively, which represents an increase of 7%, or 4% excluding impact of foreign exchange.

Other Revenues**

72

110

-35%

-34%

Decline primarily due to lower revenue from third-party manufacturing arrangements.

*Alliance revenue for this product represents the Company’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of revenues from third-party manufacturing arrangements and miscellaneous corporate revenues, including revenue-hedging activities.

Second-Quarter Expense and Related Information
The table below presents selected expense information.

$ in millions

GAAP

Acquisition-
and
Divestiture-
Related Costs4

Restructuring
Costs

(Income)
Loss From
Investments
in Equity
Securities

Non-
GAAP3

Second Quarter 2026

Cost of sales

$4,395

$1,067

$184

$-

$3,144

Selling, general and administrative

2,904

17

2,887

Research and development

9,741

6

(1)

9,736

Restructuring costs

151

151

Other (income) expense, net

99

(191)

290

Second Quarter 2025

Cost of sales

$3,557

$576

$165

$-

$2,816

Selling, general and administrative

2,649

15

1

2,633

Research and development

4,048

3

53

3,992

Restructuring costs

560

560

Other (income) expense, net

(7)

(61)

54

GAAP Expense, EPS and Related Information
Gross margin was 73.5% for the second quarter of 2026 compared with 77.5% for the second quarter of 2025. The decrease was primarily due to higher amortization of intangible assets and inventory write-downs.

Selling, general and administrative (SG&A) expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches.

Research and development (R&D) expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone Life Sciences (Blackstone). R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma.

Other (income) expense, net, was $99 million of expense in the second quarter of 2026 compared with $7 million of income in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense, partially offset by higher net income from investments in equity securities.

The income tax provision for the second quarter of 2026 was $654 million on a pretax loss of $683 million, resulting in an effective income tax rate of (95.9)%. This effective income tax rate includes a 108.9 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded.

GAAP loss per share was $0.54 for the second quarter of 2026 compared with earnings per share of $1.76 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma.

Non-GAAP Expense, EPS and Related Information
Non-GAAP gross margin was 81.1% for the second quarter of 2026 compared with 82.2% for the second quarter of 2025. The decrease was primarily due to higher inventory write-downs.

Non-GAAP SG&A expenses were $2.9 billion in the second quarter of 2026, an increase of 10% compared with the second quarter of 2025. The increase was primarily due to higher administrative costs (including investments in IT), as well as higher promotional costs in support of product launches.

Non-GAAP R&D expenses were $9.7 billion in the second quarter of 2026 compared with $4.0 billion in the second quarter of 2025. The increase was largely due to a $5.7 billion charge for the acquisition of Terns and higher clinical development spending, partially offset by a $200 million reduction in R&D expenses as part of a funding agreement with Blackstone. R&D expenses in the second quarter of 2025 include a $200 million charge for an upfront payment related to a license agreement with Hengrui Pharma.

Non-GAAP other (income) expense, net, was $290 million of expense in the second quarter of 2026 compared with $54 million of expense in the second quarter of 2025. The unfavorability was primarily due to higher net interest expense.

The non-GAAP income tax provision for the second quarter of 2026 was $882 million on pretax income of $550 million, resulting in a non-GAAP effective income tax rate of 160.3%. This effective income tax rate includes a 146.2 percentage point unfavorable impact of the charge for the acquisition of Terns, for which no tax benefit was recorded.

Non-GAAP loss per share was $0.13 for the second quarter of 2026 compared with earnings per share of $2.13 for the second quarter of 2025, largely due to higher charges for business development transactions, reflecting a $2.31 per share charge in the second quarter of 2026 for the acquisition of Terns compared with a $0.07 per share charge in the second quarter of 2025 related to a license agreement with Hengrui Pharma.

A reconciliation of GAAP to non-GAAP net (loss) income and EPS is provided in the table that follows.

Second Quarter

$ in millions, except EPS amounts

2026

2025

EPS

GAAP EPS

$(0.54)

$1.76

Difference

0.41

0.37

Non-GAAP EPS that excludes items listed below3

$(0.13)

$2.13

Net (Loss) Income

GAAP net (loss) income2

$(1,335)

$4,427

Difference

1,005

939

Non-GAAP net (loss) income that excludes items listed below2,3

$(330)

$5,366

Excluded Items:

Acquisition- and divestiture-related costs4

$1,090

$594

Restructuring costs

334

779

Income from investments in equity securities

(191)

(61)

Increase to net loss / decrease to net income before taxes

1,233

1,312

Estimated income tax benefit5

(228)

(373)

Increase to net loss / decrease to net income

$1,005

$939

Pipeline and Portfolio Highlights

In the second quarter, the Company achieved key regulatory milestones across the portfolio while continuing to advance its broad and diverse pipeline.

Oncology:
U.S. Food and Drug Administration (FDA) approved KEYTRUDA and KEYTRUDA QLEX, each with WELIREG, for the adjuvant treatment of certain patients with clear cell renal cell carcinoma (ccRCC), based on Phase 3 LITESPARK-022 trial.
Approvals represent first approved combination of a PD-1 and hypoxia-inducible factor-2 alpha inhibitor for these patients.
In July, FDA approved expanded use of KEYTRUDA and KEYTRUDA QLEX, each with Padcev, as treatment before and after surgery for adult patients with muscle-invasive bladder cancer (MIBC), including cisplatin eligible patients based on Phase 3 KEYNOTE-B15 trial; the expansion builds upon prior approval of this regimen for cisplatin ineligible patients based on Phase 3 KEYNOTE-905 trial.
FDA approved KEYTRUDA and KEYTRUDA QLEX, each with Trodelvy, for the first-line treatment of PD-L1 positive (Combined Positive Score [CPS] ≥10) advanced TNBC, based on Phase 3 KEYNOTE-D19/ASCENT-04 trial.
FDA granted Breakthrough Therapy designation (BTD) for calderasib (MK-1084), an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C-mutation and expressing PD-L1 (tumor proportion score [TPS] ≥1%).
Announced that Phase 3 TroFuse-005 trial evaluating sac-TMT, an investigational anti-TROP2 antibody-drug conjugate (ADC) being developed in collaboration with Kelun-Biotech, met its primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with advanced or recurrent endometrial cancer who have progressed after platinum-based chemotherapy and anti-PD-1/L1 immunotherapy.
First Phase 3 results from the Company’s broad sac-TMT clinical development program, which includes 17 ongoing global Phase 3 trials across multiple tumor types.
At the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, new research was presented across over 25 types of cancer, reinforcing long-term impact of KEYTRUDA and momentum in the Company’s rapidly advancing oncology pipeline, including:
Five-year follow-up data from Phase 2b KEYNOTE-942 trial, in collaboration with Moderna, underscoring continued potential of intismeran autogene (mRNA-4157/V940) in combination with KEYTRUDA for patients with stage III/IV melanoma following complete resection.
Data from Phase 3 OptiTROP-Lung05 trial, led by Kelun-Biotech, evaluating sac-TMT plus KEYTRUDA in China, adding to ongoing research of novel treatment approaches for patients with NSCLC.
Results from final analysis of KEYNOTE-522 evaluating KEYTRUDA in combination with chemotherapy, reporting a continued survival benefit for patients with high-risk early-stage TNBC.
Vaccines and Infectious Diseases:
In July, presented new data for daily and weekly options across HIV treatment and prevention pipeline at 26th International AIDS Conference (AIDS 2026). Hosted HIV investor event to highlight these data.
In collaboration with Gilead, presented first Phase 3 results for islatravir/lenacapavir (ISL/LEN), an investigational oral once-weekly single-tablet HIV treatment regimen, which maintained virological suppression in adults with HIV who switched antiretroviral therapy. ISL/LEN has the potential to be the first approved oral, once-weekly HIV treatment.
Presented first results from a Phase 2b study evaluating switch to investigational once-weekly oral islatravir and ulonivirine (ISL/ULO) in adults with virologically suppressed HIV-1.
Received regulatory approvals in Japan and China for ENFLONSIA for the prevention of RSV lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season.
Cardiometabolic and Respiratory:
In July, FDA approved LIPFENDRA (enlicitide), the first and only once-daily oral PCSK9 inhibitor, as an adjunct to diet and exercise, to reduce LDL-C in adults with hypercholesterolemia, based on two Phase 3 trials from the CORALreef clinical program: CORALreef Lipids and CORALreef HeFH.
At week 24, LIPFENDRA significantly reduced LDL-C by a placebo-adjusted 56% and 59%, respectively.
Immunology:
Announced positive topline results from Phase 3 ATLAS-UC induction-only study (Study 2) evaluating tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor-like cytokine 1A (TL1A), in patients with moderately to severely active ulcerative colitis (UC).
Initial topline results from primary analyses of two Phase 2 studies evaluating tulisokibart:
In hidradenitis suppurativa (HS), the study met its primary and key secondary endpoints. Full results will be shared at an upcoming medical meeting.
In systemic sclerosis-associated interstitial lung disease (SSc-ILD), the study did not meet its primary endpoint and will be discontinued. No new safety concerns were identified.
Business Development:
Completed acquisition of Terns for $6.8 billion.
Added MK-4208, a novel investigational oral allosteric BCR::ABL1 tyrosine kinase inhibitor recently granted BTD by the FDA for the treatment of certain adults with Philadelphia chromosome-positive chronic myeloid leukemia.
Notable recent news releases on the Company’s pipeline and portfolio are provided in the table that follows. Visit the News Releases section of the Company’s website to read the releases.*

Oncology

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With WELIREG, for Adjuvant Treatment of Certain Patients With ccRCC; Based on Results From Phase 3 LITESPARK-022 Trial

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Padcev, as Treatment Before and After Surgery for Adults With MIBC; Based on Results From Phase 3 KEYNOTE-B15 Trial, Combined With Previous Approvals Based on Phase 3 KEYNOTE-905 Trial

FDA Approved KEYTRUDA and KEYTRUDA QLEX, Each With Trodelvy, as First-Line Treatment of PD-L1+ Advanced TNBC; Based on Results From Phase 3 KEYNOTE-D19/ASCENT-04 Trial

European Commission Approved KEYTRUDA Plus Padcev as First PD-1 Inhibitor Plus ADC Regimen for Adults With Cisplatin-Ineligible Resectable MIBC; Based on Results From Phase 3 KEYNOTE-905 Trial

FDA Granted BTD for Calderasib (MK-1084), an Investigational KRAS G12C Inhibitor, for Certain Patients With Newly Diagnosed Metastatic KRAS G12C-Mutant NSCLC

The Company Announced TroFuse-005 Trial Evaluating Sac-TMT Met Primary Endpoints of OS and PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer

The Company and Moderna Presented 5-Year Data for Intismeran Autogene in Combination With KEYTRUDA in Patients With High-Risk Stage III/IV Melanoma Following Complete Resection at ASCO (Free ASCO Whitepaper) 2026

KEYTRUDA as Monotherapy Significantly Improved PFS in Certain Patients With Advanced or Recurrent Endometrial Cancer With Mismatch Repair Deficient Tumors Compared to Chemotherapy; Results From Phase 3 KEYNOTE-C93 Trial

The Company Highlighted New Long-Term Data and Advancements Across Broad Oncology Portfolio and Pipeline Research at ASCO (Free ASCO Whitepaper) 2026

The Company Completed Acquisition of Terns

Vaccines and
Infectious Diseases

The Company, in Collaboration With Gilead, Announced That the Once-Weekly Investigational Oral HIV Treatment Regimen of Islatravir and Lenacapavir (ISL/LEN) Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy

The Company Presented New Data on Daily, Weekly and Monthly Options Across its HIV Treatment and Prevention Pipeline at AIDS 2026

The Company Announced Initial Access Plans for Alimatravir (MK-8527), Its Investigational Once-Monthly Oral Pre-Exposure Prophylaxis in Phase 3 Development; Multi-Faceted Strategy Aims To Enable Rapid, Broad and Sustainable Access to Alimatravir, if Approved, in Low- And Middle-Income Countries

The Company Announced New Agreement With AIDS Drug Assistance Program Crisis Task Force To Improve Access and Care for People Living With HIV

FDA Approved an Additional Indication for CAPVAXIVE in Children and Adolescents Aged 2 Through 17 at Increased Risk for Pneumococcal Disease; Based on Results From Phase 3 STRIDE-13 Trial

Cardiometabolic and Respiratory

FDA Approved LIPFENDRA, the First and Only Once-Daily Oral PCSK9 Inhibitor To Reduce LDL-C in Adults With Hypercholesterolemia; Based on Results From CORALreef Lipids and CORALreef HeFH Trials

Immunology

Tulisokibart Met Primary and Key Secondary Endpoints in the Phase 3 ATLAS-UC Induction-only Study in Patients With Moderately to Severely Active UC

Animal Health

The Company’s Animal Health Business Completed Acquisition of TARGAN, Broadening Its Commercial Poultry Portfolio Through TARGAN’s Innovative High-Speed Biodevice Technology

*References in the above news release titles have been modified for the purpose of this announcement.

Upcoming Investor Event
The Company will hold an Oncology Investor Event to coincide with the European Society for Medical Oncology Congress 2026 on Monday, Oct. 26, 2026, at 6 p.m. CET / 1 p.m. EDT, during which senior management will provide an update on the Company’s oncology strategy and program. The event will take place in Madrid, Spain, and will be accessible via live audio webcast at this weblink.

Full-Year 2026 Financial Outlook
The following table summarizes the Company’s full-year financial outlook.

Full Year 2026

Updated

Prior

Sales*

$66.3 billion to $67.3 billion

$65.8 billion to $67.0 billion

Non-GAAP Gross margin3

Approximately 81%

Approximately 82%

Non-GAAP Operating expenses3**

$42.0 billion to $42.7 billion

$36.0 billion to $36.8 billion

Non-GAAP Other (income) expense, net3

Approximately $1.4 billion expense

Approximately $1.3 billion expense

Non-GAAP Effective income tax rate3

35.0% to 36.0%

23.5% to 24.5%

Non-GAAP EPS3***

$2.66 to $2.76

$5.04 to $5.16

Share count (assuming dilution)

Approximately 2.48 billion

Approximately 2.48 billion

*The Company does not have any non-GAAP adjustments to sales.

**Includes one-time R&D charges of $9.0 billion for the acquisition of Cidara Therapeutics, Inc. (Cidara) and $5.7 billion for the acquisition of Terns. Outlook does not assume any additional significant potential business development transactions.

***Includes one-time charges of $3.62 per share for the acquisition of Cidara and $2.31 per share for the acquisition of Terns.

The Company has not provided a reconciliation of forward-looking non-GAAP gross margin, non-GAAP operating expenses, non-GAAP other (income) expense, net, non-GAAP effective income tax rate and non-GAAP EPS to the most directly comparable GAAP measures, given it cannot predict with reasonable certainty the amounts necessary for such a reconciliation, including intangible asset impairment charges, legal settlements, and income and losses from investments in equity securities either owned directly or through ownership interests in investment funds, without unreasonable effort. These items are inherently difficult to forecast and could have a significant impact on the Company’s future GAAP results.

The Company is raising and narrowing the range for its full-year sales outlook and now anticipates full-year 2026 sales to be between $66.3 billion and $67.3 billion, including a positive impact from foreign exchange of approximately 1% at mid-July 2026 exchange rates.

The Company now expects the full-year non-GAAP effective income tax rate to be between 35.0% and 36.0%, including the impact of the non-tax deductible one-time charges for the acquisitions of Cidara and Terns.

The Company now expects full-year 2026 non-GAAP EPS to be between $2.66 and $2.76, including a positive impact from foreign exchange of approximately $0.15 per share at mid-July 2026 exchange rates. This range includes one-time charges of $9.0 billion, or $3.62 per share, related to the acquisition of Cidara and $5.7 billion, or $2.31 per share, related to the acquisition of Terns. This range also includes costs of approximately $0.12 per share to finance the Terns acquisition and advance MK-4208. The charges related to Terns were not previously included in the outlook. In 2025, non-GAAP EPS of $8.98 was negatively impacted by one-time charges of $0.20 per share in the aggregate related to certain business development transactions.

Consistent with past practice, the financial outlook does not assume additional significant potential business development transactions.

Earnings Conference Call
Investors, journalists and the general public may access a live audio webcast of the call on Tuesday, Aug. 4, at 9 a.m. EDT via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures and slides highlighting the results, will be available on the Company’s website.

All participants may join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 and using the access code 9818590.

(Press release, Merck & Co, AUG 4, 2026, View Source [SID1234669662])