On November 2, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the third quarter of 2026 (3Q26).

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"Our third-quarter performance reflects sustained execution across the business and gives us confidence to raise our full-year total revenue guidance," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "At the same time, we continue to strengthen the drivers of our future growth, with the approval and rapid launch of Ziihera in first-line HER2-positive GEA and the acquisition of Actio, which adds ABS-1230 and deepens our pipeline in rare, refractory epilepsies. Jazz is moving with momentum and urgency to advance practice-changing medicines that deliver meaningful benefit for patients and durable value for shareholders."

Recent Key Highlights

•Achieved total revenues of $1.2 billion in 3Q26, reflecting 10% year-over-year (YoY) growth.
•Received U.S. Food and Drug Administration (FDA) approval and rapidly launched Ziihera-based combinations in first-line (1L) gastroesophageal adenocarcinoma (GEA).
•Presented final analysis from the HERIZON-GEA-01 trial at European Society for Medical Oncology Congress 2026 (ESMO) (Free ESMO Whitepaper), demonstrating sustained survival benefit at three years. Longer follow up of Ziihera plus tislelizumab and chemotherapy showed an improved overall survival (OS) hazard ratio of 0.65, further supporting Ziihera-based combinations as standard-of-care.
•Closed acquisition of Actio Biosciences, Inc. (Actio), adding ABS-1230 (JZP6979) to rare epilepsy portfolio.
•Generated $1.3 billion in cash from operations in the first nine months of 2026.
•Raised 2026 total revenue guidance to a range of $4.775 – $4.85 billion.

Business Updates

Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
•Xywav net product sales increased 12% YoY to $483 million in 3Q26.
•Robust new patient growth drove revenue, with approximately 425 net patient adds in 3Q26. There were approximately 17,550 active patients exiting the quarter, comprised of approximately 11,375 narcolepsy patients and approximately 6,175 idiopathic hypersomnia patients.
•Continued physician and patient demand for the differentiated benefits of low-sodium Xywav.

Epidiolex/Epidyolex (cannabidiol):
•Epidiolex/Epidyolex net product sales decreased 2% YoY to $295 million in 3Q26. The 3Q26 growth rate was negatively affected by lower U.S. gross-to-net deductions in 3Q25 and lower levels of inventory build in 3Q26 due to wholesaler buying patterns.
•The PDUFA target action date for our New Drug Application (NDA) for the oral cannabidiol capsule formulation is April 16, 2027.

Ziihera (zanidatamab-hrii):
•Ziihera net product sales were $21 million in 3Q26.
•Ziihera received FDA approval on August 25, 2026, and was launched promptly for the first-line treatment of adult patients with HER2-positive (HER2+) unresectable locally advanced or metastatic GEA.
•Promising early demand from first full month of 1L GEA launch with ~40% increase in average demand vials per selling day and a threefold increase in new ordering accounts, 80% of which are community based.
•Positive results from the second and final OS analysis for the HERIZON-GEA-01 trial were presented at ESMO (Free ESMO Whitepaper). Mature HERIZON-GEA-01 results showed Ziihera plus chemotherapy delivered statistically significant and clinically meaningful OS benefit. Nearly 40% of patients were alive at three years with Ziihera plus tislelizumab and chemotherapy, irrespective of PD-L1 status, achieving a median OS of 27 months.
•NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer, and Esophageal and Esophagogastric Junction Cancers, were updated to include Ziihera (zanidatamab-hrii) in combination with chemotherapy, with and without Tevimbra (tislelizumab-jsgr), as a preferred regimen for first-line treatment of adult patients with HER2+ unresectable locally advanced or metastatic GEA.

Modeyso (dordaviprone):
•Modeyso net product sales were $61 million in 3Q26 with approximately 725 patients having received Modeyso from product launch in August 2025 through the end of 3Q26.
•The company anticipates the OS interim analysis for the event-driven Phase 3 ACTION trial in 1H27, based on the current pace of event accrual.

Zepzelca (lurbinectedin):
•Zepzelca net product sales increased 32% YoY to $104 million in 3Q26, driven by continued uptake of the Zepzelca and atezolizumab combination in the 1L maintenance extensive-stage small-cell lung cancer setting, partially offset by a decline in second-line use.
•On September 30, 2026, the FDA approved the label supplement removing the second-line indication.

Actio Acquisition:
•Completed the Actio acquisition in September 2026, adding ABS-1230 (JZP6979) to rare epilepsy portfolio.
•Potential first-in-class precision therapy for KCNT1-related epilepsy which has demonstrated meaningful seizure reductions in an early clinical proof-of-concept trial in children with KCNT1 epilepsy.
•Currently being evaluated in the ongoing Phase 1b/2a KYRON trial designed to serve as a registrational study to support an NDA submission in the U.S.
•Expect to present initial patient data at a medical meeting in 4Q26.

Capital Structure
In the third quarter of 2026, the company completed a private placement of $1.25 billion aggregate principal amount of 1.875% exchangeable senior notes due 2032 (2032 notes). Concurrent with this transaction, the company repurchased $225 million of its ordinary shares. The company paid for the repurchases with existing cash on hand, and the share repurchases were effected under, and completely exhausted, the company’s share repurchase program announced in July 2024. In October 2026, the board of directors approved a new share repurchase program with no expiration date pursuant to which the company may repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions.
Additionally, in the third quarter, the company amended and extended the company’s Term Loan B, reducing the applicable margin by 50 basis points and extending the maturity by five years to May 2033, which is expected to generate cash interest savings and maintain cash reserves.

Financial Highlights
Three Months Ended
September 30, Nine Months Ended
September 30,
(In millions, except per share amounts) 2026 2025 2026 2025
Total revenues $ 1,243.0 $ 1,126.1 $ 3,520.2 $ 3,069.6
GAAP net income (loss) $ (483.4) $ 251.4 $ 2.5 $ (559.6)
Non-GAAP adjusted net income (loss) $ (250.8) $ 500.7 $ 565.1 $ 101.0
GAAP earnings (loss) per share $ (7.48) $ 4.08 $ 0.04 $ (9.18)
Non-GAAP adjusted earnings (loss) per share $ (3.88) $ 8.13 $ 8.23 $ 1.63

GAAP net loss and non-GAAP adjusted net loss in 3Q26 included acquired in-process research and development (IPR&D) expense of $754 million representing the value allocated to ABS-1230 (JZP6979) in the Actio acquisition, which impacted our results by $11.32 per share and $11.03 per share on a GAAP and non-GAAP adjusted basis, respectively.
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

Total Revenues
Three Months Ended
September 30, Nine Months Ended
September 30,
(In millions) 2026 2025 2026 2025
Xywav $ 482.8 $ 431.4 $ 1,362.2 $ 1,191.5
Xyrem 31.2 35.7 92.9 108.3
Sleep 514.0 467.1 1,455.1 1,299.8
Epidiolex/Epidyolex 295.4 302.6 837.3 772.0
Epilepsy 295.4 302.6 837.3 772.0
Zepzelca 104.4 79.3 311.2 216.8
Rylaze/Enrylaze 106.3 99.9 309.5 294.8
Defitelio/defibrotide 60.7 51.7 170.1 140.5
Modeyso 61.1 11.0 150.7 11.5
Vyxeos 34.0 37.6 92.0 112.0
Ziihera 20.6 8.3 49.3 16.3
Oncology 387.1 287.8 1,082.8 791.9
Other — 6.9 2.7 25.7
Product sales, net 1,196.5 1,064.4 3,377.9 2,889.4
High-sodium oxybate AG royalty revenue 38.4 52.9 116.9 155.9
Other royalty and contract revenues 8.1 8.8 25.4 24.3
Total revenues $ 1,243.0 $ 1,126.1 $ 3,520.2 $ 3,069.6

Total revenues increased 10% YoY in 3Q26 primarily due to higher Xywav, Zepzelca and Ziihera net product sales and the inclusion of Modeyso net product sales, following FDA approval in August 2025.

Operating Expenses and Income Tax Expense (Benefit)
Three Months Ended
September 30, Nine Months Ended
September 30,
(In millions, except percentages) 2026 2025 2026 2025
GAAP:
Cost of product sales $ 110.6 $ 128.9 $ 361.1 $ 349.8
Gross margin on total revenues 91.1% 88.6% 89.7% 88.6%
Selling, general and administrative $ 407.9 $ 530.6 $ 1,149.8 $ 1,403.0
% of total revenues 32.8% 47.1% 32.7% 45.7%
Research and development $ 211.9 $ 198.2 $ 615.4 $ 568.8
% of total revenues 17.0% 17.6% 17.5% 18.5%
Acquired in-process research and development $ 754.2 $ 42.5 $ 831.2 $ 947.9
Gain on sale of priority review voucher $ — $ — $ (122.8) $ —
Income tax expense (benefit) $ 24.5 $ (242.4) $ 48.7 $ (277.4)
Effective tax rate (5.3)% N/A(1) 94.9% 33.2%
Three Months Ended
September 30, Nine Months Ended
September 30,
(In millions, except percentages) 2026 2025 2026 2025
Non-GAAP adjusted:
Cost of product sales $ 105.1 $ 83.2 $ 290.2 $ 229.2
Gross margin on total revenues 91.5% 92.6% 91.8% 92.5%
Selling, general and administrative $ 328.0 $ 460.1 $ 979.7 $ 1,242.7
% of total revenues 26.4% 40.9% 27.8% 40.5%
Research and development $ 188.9 $ 169.9 $ 546.1 $ 496.7
% of total revenues 15.2% 15.1% 15.5% 16.2%
Acquired in-process research and development $ 754.2 $ 42.5 $ 831.2 $ 947.9
Income tax expense (benefit) $ 72.1 $ (178.8) $ 187.7 $ (100.1)
Effective tax rate (40.3)% (55.5)% 24.9% N/A(1)

_________________________
1.Not a meaningful metric due to minimal profit before tax in this period.

Changes in operating expenses and income tax expense (benefit) in 3Q26 over the prior year period are primarily due to the following:
•Cost of product sales, on a GAAP basis, decreased in 3Q26, primarily due to the full recognition of the inventory fair value step-up in the second quarter of 2026, partially offset by higher royalty expenses, driven by higher revenues of Modeyso and Zepzelca. Cost of product sales, on a non-GAAP adjusted basis, increased in 3Q26, primarily due to the higher royalty expenses.
•Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 3Q26, primarily due to litigation settlements of $152 million in 3Q25, partially offset, on a GAAP basis, by restructuring expenses of $34 million included in 3Q26.
•Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, increased in 3Q26, reflecting continued investment in our pipeline portfolio and evidence generation.
•Acquired IPR&D of $754 million, on a GAAP and non-GAAP adjusted basis, in 3Q26, represents the value allocated to ABS-1230 (JZP6979) in the Actio acquisition.
•We recognized an income tax expense, on a GAAP and non-GAAP adjusted basis, in 3Q26 compared to an income tax benefit in 3Q25, which included a benefit of $206 million on recognition of certain U.S. federal and state deferred tax assets acquired through our acquisition of Chimerix.

Cash Flow and Balance Sheet
As of September 30, 2026, cash, cash equivalents and investments were $2.9 billion, and the outstanding principal balance of the company’s long-term debt was $5.6 billion. In addition, the company had undrawn borrowing capacity under a revolving credit facility of $885 million. For the nine months ended September 30, 2026, the company generated $1.3 billion of cash from operations reflecting strong business performance and continued financial discipline.

2026 Financial Guidance
Jazz Pharmaceuticals has updated its full-year financial guidance, as shown in the table below, including raising its full-year 2026 revenue guidance, increasing its GAAP SG&A expense guidance to include restructuring expenses, and updating its effective tax rate guidance range to reflect the impact of the acquired IPR&D expense associated with the Actio acquisition.

(Press release, Jazz Pharmaceuticals, NOV 2, 2026, View Source [SID1234674033])

On November 2, 2026 CRISPR Therapeutics (Nasdaq: CRSP) reported financial results for the third quarter ended September 30, 2026.

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"The third quarter marked meaningful progress for CRISPR Therapeutics," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "CASGEVY is reaching more patients, including younger children following new approvals in the U.K. and the Middle East, and the FDA’s RMAT designations for CTX310 underscore its potential to address significant unmet needs in cardiovascular disease. With new clinical data from CTX310 and zugo-cel in the coming weeks and enrollment complete in our Phase 2 trial of CTX611, we are entering a pivotal period for our pipeline."

Recent Highlights and Outlook

Hemoglobinopathies and CASGEVY (exagamglogene autotemcel)

•
CASGEVY, the world’s first approved CRISPR-based therapy, has been shown to reduce or eliminate vaso-occlusive crises (VOCs) in eligible patients with sickle cell disease (SCD) and transfusion requirements in eligible patients with transfusion-dependent beta thalassemia (TDT). CASGEVY is approved in 39 countries across North America, Europe, and the Middle East for eligible patients 12 years of age and older, with approvals for younger children in five of those countries.
•
CASGEVY generated third quarter 2026 revenue of $99 million, representing 30% growth quarter-over-quarter and nearly six times the revenue reported in the third quarter of 2025. Twice as many in the first nine months of 2026 as in all of 2025, and more than 750 patients have initiated treatment worldwide.
•
CASGEVY’s availability for younger patients continues to expand. In July, the FDA approved CASGEVY for children 2 years of age and older with SCD or TDT, making it the first genetic therapy for SCD and TDT approved for this age group, and multiple children have since initiated treatment in the U.S. The Kingdom of Saudi Arabia, the United Arab Emirates, and the Kingdom of Bahrain have also approved CASGEVY for children 2 years of age and older, and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) approved CASGEVY for children 5 years of age and older with severe SCD or TDT.
•
Building on CASGEVY, CRISPR Therapeutics is advancing an in vivo hematopoietic stem cell editing approach that could extend gene editing to many more patients with SCD and TDT. Using lipid nanoparticle (LNP)-mediated delivery, the approach is designed to edit stem cells directly in the body, potentially simplifying treatment and broadening global access.
In Vivo Liver Editing

CRISPR Therapeutics continues to advance a diversified portfolio of in vivo gene editing programs leveraging its proprietary liver-directed LNP delivery platform.

•
The Phase 1 clinical trial of CTX310, targeting angiopoietin-related protein 3 (ANGPTL3) is ongoing.

•
CRISPR Therapeutics reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designations to CTX310 for the treatment of severe hypertriglyceridemia (sHTG) and for the treatment of patients with elevated LDL-C. RMAT designation provides the benefits of Fast Track and Breakthrough Therapy designations, including early interactions with the FDA and potential eligibility for priority review and accelerated approval.
•
In August, CRISPR Therapeutics presented Phase 1a durability data for CTX310 in a late-breaking session at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in The New England Journal of Medicine. A single course treatment of CTX310 produced deep and durable reductions in circulating ANGPTL3, triglycerides (TG), and low-density lipoprotein (LDL) that were sustained through one year of follow-up. At the highest dose, the mean reductions from baseline were 79% in ANGPTL3, 48% in triglycerides, and 53% in LDL-C in a mixed patient cohort with high triglycerides, high LDL-C, or both. CTX310 was well tolerated with no treatment-related serious adverse events.
•
Phase 1b data in patients with sHTG will be presented in a late-breaking oral presentation at the American Heart Association (AHA) Scientific Sessions 2026 on November 9, 2026, at 8:00 a.m. CT.
•
The Phase 1 clinical trial of CTX340, targeting angiotensinogen (AGT), in patients with refractory hypertension is ongoing.
•
The Phase 1 clinical trial of CTX460, targeting SERPINA1 for alpha-1 antitrypsin deficiency (AATD), is ongoing. CTX460 is the first investigational candidate from the Company’s SyNTase editing platform.
•
CTX321, the Company’s next-generation LPA program, is progressing through IND/CTA-enabling studies.
siRNA-based Programs

CRISPR Therapeutics’ small interfering RNA (siRNA)-based portfolio, developed in collaboration with Sirius Therapeutics, includes programs targeting cardiovascular and thromboembolic diseases.

•
CRISPR Therapeutics has completed enrollment in the Phase 2 clinical trial of CTX611 (SRSD107), a long-acting siRNA therapeutic targeting Factor XI (FXI), in patients undergoing total knee arthroplasty (TKA), with an update expected in the second half of 2026. CTX611 has potential across a broad range of thromboembolic indications. CRISPR Therapeutics will lead global Phase 3 development, with Sirius Therapeutics overseeing development in greater China.
•
CRISPR Therapeutics has the option to nominate up to two additional siRNA targets, with an update expected in 2027.
Autoimmune Disease and Immuno-Oncology

Zugocabtagene geleucel (zugo-cel; formerly CTX112) continues to advance across both autoimmune disease and hematologic malignancies.

•
In autoimmune disease, zugo-cel is being evaluated in three ongoing Phase 1 trials: a rheumatology basket including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis (IM); a hematology basket in immune thrombocytopenic purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA); and a trial in autoimmune neurologic diseases, including progressive multiple sclerosis (PMS), neuromyelitis optica spectrum disorder (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), N-methyl-D-aspartate receptor (NMDAR) and leucine-rich glioma-inactivated protein 1 (LGI1) autoimmune encephalitis (AIE), and stiff person syndrome (SPS). Enrollment is ongoing globally.
•
Phase 1 clinical data in patients with refractory SSc will be presented in a poster presentation at the American College of Rheumatology (ACR) Convergence 2026 on November 8 at 10:30 a.m. ET.
•
In immuno-oncology, the Phase 1/2 clinical trial of zugo-cel in B-cell malignancies is ongoing, with updates anticipated in the second half of 2026. A combination study evaluating zugo-cel with pirtobrutinib in aggressive B-cell lymphomas, under the Company’s existing collaboration with Lilly, is also ongoing.
CRISPR Therapeutics is also advancing a proprietary in vivo CAR-T platform with potential applications across autoimmune disease and oncology.

The Company is pursuing two modalities, supported by an antibody-conjugated LNP delivery system targeting immune cells: a transient, re-dosable mRNA-based CAR-T and a non-viral, integrating CAR-T, for which the Company is evaluating multiple integration approaches. Both programs are in the IND/CTA-enabling phase, focused on a best-in-class profile.

Regenerative Medicine

•
The Company is developing CTX213, a deviceless beta cell replacement candidate for Type 1 diabetes, consisting of unencapsulated precursor islet cells derived from edited induced pluripotent stem cells (iPSCs). CTX213 has demonstrated compelling preclinical efficacy through direct administration and is progressing toward the clinic.
Other Corporate Matters

•
Earlier today, CRISPR Therapeutics announced the appointment of Sivakesava Sakhamuri, Ph.D., as Chief Technical Officer, effective immediately. Dr. Sakhamuri brings more than 30 years of technical operations and quality leadership across biologics, vaccines, oligonucleotides, RNA therapeutics, and LNP delivery, most recently as Chief Technical Officer at Orna Therapeutics.
•
In October, CRISPR Therapeutics announced the appointment of A.J. Silver, the Company’s Senior Vice President of Finance, as Chief Financial Officer, effective October 19, 2026, succeeding Raju Prasad, Ph.D., who stepped down to pursue external opportunities.
•
The Company’s in vivo and cell therapy programs are supported by a wholly-owned GMP manufacturing facility in Framingham, Massachusetts. The facility provides end-to-end production capabilities, supports both clinical and future commercial supply, and enables an industry-leading cost of goods.
Third Quarter 2026 Financial Results

•
Cash Position: Cash, cash equivalents, and marketable securities were $2,276.6 million as of September 30, 2026, compared to $1,975.8 million as of December 31, 2025. The increase in cash was primarily driven by net proceeds of $585.4 million from the issuance of convertible senior notes in March 2026, offset by operating expenses.
•
R&D Expenses: R&D expenses were $71.9 million for the third quarter of 2026, compared to $58.9 million for the third quarter of 2025. The increase in R&D expense was primarily attributable to an increase in external research and development expenses and sublicense fees, offset by a decrease in employee-related costs.
•
Acquired In-Process R&D Expenses: Acquired in-process R&D expenses were $11.7 million for the third quarter of 2026. Acquired in-process R&D expenses for the third quarter of 2026 primarily consisted of a development milestone under the Sirius Agreement that was recognized in the third quarter of 2026. No acquired in-process R&D expenses were recognized during the third quarter of 2025.
•
G&A Expenses: General and administrative expenses were $17.9 million for the third quarter of 2026, compared to $16.9 million for the third quarter of 2025.
•
Collaboration Expense: Collaboration expense, net, was $41.3 million for the third quarter of 2026, compared to $57.1 million for the third quarter of 2025. The decrease was primarily attributable to an increase in the Company’s share of CASGEVY revenue.
•
Net Loss: Net loss was $111.4 million for the third quarter of 2026, compared to a net loss of $106.4 million for the third quarter of 2025.
About CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT), in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT.

CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world, and for younger children in select countries.

(Press release, CRISPR Therapeutics, NOV 2, 2026, View Source [SID1234674032])

On November 2, 2026 CorMedix Therapeutics (Nasdaq: CRMD) reported a business update in advance of a conference call expected to be held on November 12, 2026 to discuss the Company’s complete quarterly financial performance.

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Business Updates

CorMedix announces unaudited cash and cash equivalents on hand as of September 30, 2026 of approximately $355 million.
CorMedix reaffirms its August 2026 total revenue guidance of between $325 million and $345 million for the full-year 2026.
On October 28, 2026, CMS released the 2027 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule, which provided for a post-TDAPA Add-on for DefenCath (taurolidine and heparin) of $8.32 per dialysis session, for Q1 of 2027, as well as a new quarterly process for calculating Add-On adjustments. The Q1 2027 Add-on of $8.32 is within the Company’s previously guided range of 3x-5x higher than the current $2.37 in effect for the third and fourth quarters of 2026.
The Company is aware of statements made by a large dialysis organization (LDO) during its investor call about the quarterly trajectory of the 2027 DefenCath post-TDAPA Add-on payments following CMS’s publication of the 2027 ESRD PPS Final rule. CorMedix has not provided the LDO or any other party with past or forecasted utilization or pricing data that would be necessary to estimate future quarterly adjustments to the 2027 Add-on. We believe any third-party projections regarding future quarterly adjustments are subject to significant uncertainty without visibility into the relevant utilization and pricing data. Investors should not interpret third-party projections as guidance provided or endorsed by CorMedix.
Based on CorMedix evaluation of sales data and insights that the Company has in connection with DefenCath fee-for-service utilization, including terms of its contractual arrangements with customers, the Company anticipates that the DefenCath Add-on will decline in Q2 of 2027 compared to Q1, but increase in Q3 and/or Q4 of 2027 compared to Q2, subject to how CMS applies certain utilization data. In addition, CorMedix believes that the Add-on rate for all four quarters in 2027 will exceed the current rate of $2.37 and that the average Add-on rate for all four quarters in 2027 will equate to more than 2x the current rate of $2.37.
CorMedix expects to hold a conference call on November 12, 2026 to discuss its financial results and additional business updates at that time. The Company will provide more specifics about its third quarter earnings call approximately one week prior to the scheduled meeting.

(Press release, CorMedix, NOV 2, 2026, View Source [SID1234674031])

On November 2, 2026 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2026, and provided a business update.

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"Our solid performance in Q3 builds upon a strong first half of 2026 and increases our confidence as we approach year-end," said Vivek Jayaraman, Cerus’s president and chief executive officer. "Continued growth from our IFC business, core platelet franchise and international INT 200 rollout strengthens our foundation as we work to establish INTERCEPT as the global standard of care. The positive topline results we announced today from the Phase 3 RedeS study mark an important milestone as we drive toward extending the benefits of pathogen reduction to red cell transfusions. I’m pleased with our progress and grateful to my colleagues who remain focused on delivering for our customers and the patients they serve."

Achieved third-quarter 2026 product revenue of $57.7 million representing 10% growth compared to the prior year period.
Three Months Ended

Nine Months Ended

September 30,

Change

September 30,

Change

2026

2025

$

%

2026

2025

$

%

Product Revenue

$

57.7

$

52.7

$

5.0

10

%

$

168.8

$

148.4

$

20.4

14

%

Government Contract Revenue

6.3

7.5

(1.2

)

-16

%

18.4

20.8

(2.4

)

-12

%

Total Revenue

$

64.0

$

60.2

$

3.8

6

%

$

187.2

$

169.2

$

18.0

11

%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

Drove approximately 80% growth in INTERCEPT Fibrinogen Complex (IFC) volumes – including kits and finished therapeutic doses (measured in FC15* equivalent units) compared to the prior year period. Third quarter U.S. IFC sales totaled $5.6 million, up from $3.9 million in the prior year period.
Announced positive topline results from the Phase 3 RedeS trial of the INTERCEPT Blood System for red blood cells.
Appointed Betsy Jensen as chief human resources officer, fully effective December 2026. Ms. Jensen joins Cerus from Standard BioTools, where she has served as senior vice president and chief human resources officer.
Generated operating cash flow of $3.0 million in the third quarter of 2026. Increased cash, cash equivalents, and short-term investments by $0.8 million compared to June 30, 2026 to $57.1 million at September 30, 2026.
Revenue

Product revenue for the third quarter of 2026 was $57.7 million, compared to $52.7 million for the prior year period, representing year-over-year growth of 10%. Third quarter growth was driven by higher U.S. IFC sales, strength of the U.S. platelet franchise, and INT200 illuminator sales in EMEA.

Government contract revenue for the third quarter of 2026 was $6.3 million, compared to $7.5 million during the prior year period. The decrease reflects the completion of the Company’s FDA contract in 2025 and the wind-down of the Biomedical Advanced Research and Development Authority (BARDA) 2016 contract which was offset in part by an increase in expenses related to the BARDA 2024 contract.

Product Gross Profit & Margin

Product gross profit for the third quarter of 2026 was $30.3 million, compared to $28.1 million, increasing by 8% over the prior year period. Product gross margin for the third quarter was 52.4% compared to 53.4% in the same period last year. The year-over-year decrease in gross margin was largely driven by a weaker U.S. dollar relative to the euro and higher product costs driven by inflationary pressures offset partially by pricing and favorable product mix shift.

Operating Expenses

Total operating expenses for the third quarter of 2026 were $36.2 million, compared to $34.4 million for the same period of the prior year, reflecting a year-over-year increase of 5%.

R&D expenses for the third quarter of 2026 were $14.3 million, compared to $15.8 million in the third quarter of 2025. The decrease primarily reflected lower costs associated with the RedeS study following completion of enrollment, INT200 development following the U.S. PMA submission, and expenses tied to government-funded projects, as reflected in government contract revenue.

SG&A expenses totaled $21.9 million for the third quarter of 2026, compared to $18.6 million for the third quarter of 2025. The year-over-year increase in SG&A expenses was due in part to higher employee-related expenses. In addition, SG&A expenses for Q3 2025 benefited from a one-time tax credit.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the third quarter of 2026 was $0.6 million, or $0.00 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $0.02 million, or $0.00 per basic and diluted share, for the same period of the prior year. Net loss attributable to Cerus Corporation for the first nine months of 2026 was $5.1 million, compared to net loss attributable to Cerus Corporation of $13.4 million for the first nine months of 2025.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the third quarter of 2026 was positive $5.7 million, compared to non-GAAP adjusted EBITDA of positive $5.0 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first nine months of 2026 was a positive $12.7 million compared to non-GAAP adjusted EBITDA of positive $6.1 million for the first nine months of 2025.

Balance Sheet and Cash Flows

At September 30, 2026, the Company had cash, cash equivalents, and short-term investments of $57.1 million, compared to $82.9 million at December 31, 2025 and $56.3 million at June 30, 2026.

As of September 30, 2026, the Company had $35.0 million outstanding on its term loan and $28.5 million drawn on its revolving credit facility, down from $30.1 million drawn at June 30, 2026. Subject to borrowing base levels, the Company’s revolving line of credit allows for an additional $16.5 million as of September 30, 2026.

For the third quarter of 2026, cash generated from operations totaled $3.0 million, compared to $1.9 million generated during the same period of the prior year. Cash generated from operations in the third quarter of 2026 was driven by sequentially improved bottom-line results and inventory management.

Reiterating Full-Year 2026 Product Revenue Guidance

The Company continues to expect full-year 2026 product revenue to be in the range of $229 million to $231 million, reflecting growth of 11% to 12% from 2025. Included in this range is full-year 2026 IFC revenue guidance of $23 million to $25 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results, topline results from the Phase 3 RedeS study, and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through November 23, 2026.

*FC15 equivalent to a therapeutic dose of a cryoAHF pool.

Development of the INTERCEPT Blood System for Red Blood Cells has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Center for Biomedical Advanced Research and Development Authority (BARDA), under contract numbers HHSO100201600009C and 75A50124C00046.

(Press release, Cerus, NOV 2, 2026, View Source [SID1234674030])

On November 2, 2026 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported financial results for the third quarter ended September 30, 2026.

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"BioMarin delivered a strong quarter, with revenue growth of 32%, driven by a more diversified portfolio following the acquisition of Amicus Therapeutics earlier this year and increased demand for our medicines from patients around the world. For the first time, quarterly revenue exceeded $1 billion, a milestone for BioMarin," said Alexander Hardy, President and Chief Executive Officer of BioMarin. "We are building on this achievement by continuing to expand our pipeline through focused business development. We are excited to add our newest asset, an investigational treatment for Fabry disease, which has the potential to become the first subcutaneous enzyme therapy for this condition. With this fourth new asset added to our pipeline in 2026, we are following through on our commitment to build sustainable growth for the future." Mr. Hardy added, "As we approach 2027, we are well positioned for our next chapter of growth, including the potential launch of VOXZOGO in hypochondroplasia and the continued execution of our financial and innovation strategy."

2026 Business and Pipeline Highlights
Innovation
•BioMarin is accelerating innovation by expanding its pipeline through business development. Four transactions in 2026 have added development programs from preclinical through Phase 3:

◦BMN 450 (HM15421/GC1134A) is an investigational long-acting enzyme replacement therapy (ERT) that has the potential to be the first subcutaneous ERT for Fabry disease. Now in a global Phase 1/2 clinical study, it could extend BioMarin’s reach beyond patients with genetic variants amenable to GALAFOLD.

◦BMN 440 (ALE1) for hypophosphatasia (HPP) is a potential first-in-class oral therapy for HPP. The Phase 1/2a study in healthy volunteers and adults with HPP is ongoing, with data expected in 2027.

◦BMN 430 for ReNU syndrome has the potential to be a first-in-disease antisense oligonucleotide (ASO) medicine for ReNU syndrome, a serious, rare neurodevelopmental condition with no approved targeted therapies. Preclinical studies are underway to identify a lead ASO candidate.

◦BMN 820 (DMX-200) for focal segmental glomerulosclerosis (FSGS) is a first-in-class oral CCR2 inhibitor for which BioMarin holds exclusive U.S. commercialization rights. The Phase 3 ACTION 3 trial is fully enrolled, with pivotal data expected in 2028.

•Today, BioMarin announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA target action date of May 30, 2027 for its supplemental NDA to expand the use of VOXZOGO for the treatment of HCH, the first potential targeted therapy for the condition. BioMarin also announced today that the European Medicines Agency (EMA) validated its submission for the approval of VOXZOGO to treat HCH.

•BioMarin’s application for full approval of VOXZOGO in children with achondroplasia is under review by the FDA, with a PDUFA target action date of February 28, 2027. The application includes long-term safety and efficacy data, such as final adult height and clinical outcomes beyond linear growth.

•The Phase 2/3 study for BMN 333, BioMarin’s long-acting C-type natriuretic peptide (CNP) for achondroplasia, continues to enroll on track. Dose-response data from this study is expected in 2027.

•In October, five-year results from the PROPEL open-label extension study with POMBILITI + OPFOLDA were presented in a late-breaking presentation at the World Muscle Society Annual Congress. In adults with late-onset Pompe disease, POMBILITI + OPFOLDA demonstrated durable motor function outcomes and relative stabilization of pulmonary function. This included people who had received enzyme replacement therapy for a mean of 7.6 years before enrolling. No new safety signals were identified.
•For BMN 351, BioMarin’s Phase 1/2 candidate for Duchenne muscular dystrophy, the company expects to provide a program update by year-end.
Growth
•In the first full quarter as part of BioMarin, GALAFOLD and POMBILITI + OPFOLDA delivered strong quarterly revenue, contributing $152 million and $49 million, respectively. The number of patients treated with GALAFOLD and POMBILITI + OPFOLDA increased by approximately 13% and 69% Y/Y, respectively. POMBILITI + OPFOLDA uptake benefited from supply constraints for other Pompe therapies.
•Metabolic Conditions revenue grew 44% Y/Y in the third quarter of 2026 and 26% Y/Y year-to-date. Growth was driven by the additions of GALAFOLD and POMBILITI + OPFOLDA and by higher VIMIZIM revenue. The number of patients on therapy increased across all BioMarin-marketed Metabolic Conditions therapies, Y/Y.
•VOXZOGO revenue grew 12% Y/Y in the third quarter of 2026, and the number of children treated with VOXZOGO globally increased 17% Y/Y. As of the end of the quarter, children with achondroplasia in 58 countries around the world were being treated with VOXZOGO. More than 75% of VOXZOGO revenue was generated outside of the U.S., and a large international order previously expected in the third quarter is now anticipated in the fourth quarter. In the U.S., the majority of new patient starts were in children under the age of two.

Value Commitment
•BioMarin continued to integrate Amicus in the third quarter, realizing accelerated cost synergies to enable investments in initiatives to drive future growth of GALAFOLD and POMBILITI + OPFOLDA. BioMarin continues to expect approximately $280 million of GAAP cost synergies (approximately $220 million on a Non-GAAP basis) to be fully realized in 2028.
•On August 30, 2026, the company announced the global settlement of all outstanding claims with Ascendis Pharma A/S related to its product Yuviwel. As part of the agreement, Ascendis will pay BioMarin a royalty equal to 20% of net sales of Yuviwel in the U.S., retroactive to the first commercial sale, and 18% of net sales in the European Union, Brazil and South Korea until May 2030.

Third Quarter 2026 Financial Highlights
•Total Revenues for the third quarter of 2026 were $1,025 million, an increase of 32% compared to the same period in 2025, primarily driven by revenues from GALAFOLD and POMBILITI + OPFOLDA, which were acquired on April 27, 2026, as well as 18% revenue growth in VIMIZIM due to timing of large international orders. In the quarter, VOXZOGO revenue also increased by 12% due to new patients initiating therapy. These increases were partially offset by a decrease in NAGLAZYME revenue due to timing of large international orders.

•GAAP Net Loss increased to $123 million compared to $31 million for the same period in 2025. The increase was primarily driven by the acquisition of Amicus Therapeutics (Amicus), including intangible asset amortization, interest expense from debt issued to finance a portion of the transaction, amortization of inventory fair value step-up, and integration and restructuring costs. The increase was also attributed to acquired in-process research and development (IPR&D) charges recorded in the quarter in connection with the acquisition of Alesta Therapeutics (Alesta). These increases were partially offset by revenue growth as described above.

•Non-GAAP Income for the third quarter of 2026 increased to $45 million compared to $22 million for the same period in 2025. The increase was primarily driven by revenue growth, partially offset by higher acquired IPR&D charges and higher interest expense, as described above. The increases were also partially offset by higher sales and marketing spend related to GALAFOLD and POMBILITI + OPFOLDA.

Financial Highlights (in millions of U.S. dollars, except percentages and per share data, unaudited)
Three Months Ended
September 30, Nine Months Ended
September 30,
2026 2025 % Change 2026 2025 % Change
Total Revenues $1,025 $776 32% $2,781 $2,347 18%
Net Product Revenues by Product:
VOXZOGO $245 $218 12% $717 $654 10%
Metabolic Conditions:
VIMIZIM $216 $183 18% $620 $587 6%
NAGLAZYME 108 122 (11)% 373 365 2%
PALYNZIQ
111 109 2% 336 308 9%
GALAFOLD 152 — NM 258 — NM
BRINEURA
53 48 10% 151 137 10%
ALDURAZYME
57 54 6% 137 159 (14)%
POMBILITI + OPFOLDA 49 — NM 79 — NM
Total Metabolic Conditions Revenue $744 $516 44% $1,954 $1,556 26%
KUVAN
$23 $24 (4)% $71 $76 (7)%
ROCTAVIAN(1)
$1 $3 (67)% $15 $23 (35)%
GAAP Net Income (Loss) $(123) $(31) 297% $27 $395 (93)%
Non-GAAP Income (2)
$45 $22 105% $430 $525 (18)%
GAAP Operating Margin % (3)
(8.0)% (6.0)% 5.7% 19.4%
Non-GAAP Operating Margin % (2)
13.4% 2.8% 24.6% 26.3%
GAAP Diluted EPS
$(0.63) $(0.16) 294% $0.14 $2.04 (93)%
Non-GAAP Diluted EPS (2)
$0.23 $0.12 92% $2.18 $2.69 (19)%

(Press release, BioMarin, NOV 2, 2026, View Source [SID1234674029])