Cerus Q3 Earnings Call Highlights

Key Points

• Cerus reported solid growth, with third-quarter product revenue up 10% year over year to $57.7 million and nine-month revenue up 14% to $168.8 million. The company reaffirmed its 2026 product revenue outlook of $229 million to $231 million.
• The Phase III RedeS study of INTERCEPT-treated red blood cells met its primary non-inferiority endpoint, with no statistically significant difference in treatment-emergent adverse events. Cerus plans further analysis and regulatory submissions, though European CE-mark clearance is now expected in late 2027.
• Profitability continued to improve: adjusted EBITDA reached $5.7 million for the 10th consecutive positive quarter, GAAP net loss was below $1 million, and operating cash flow was $3 million. Cerus also expects its IFC business to transition almost entirely to the higher-margin blood-center kit model by 2027.

Cerus NASDAQ: CERS reported third-quarter product revenue growth of 10% year over year and reaffirmed its 2026 revenue outlook, while also announcing positive top-line results from its Phase III RedeS study of pathogen-reduced red blood cells.

Product revenue totaled $57.7 million for the quarter ended Sept. 30, up from the prior-year period. For the first nine months of 2026, product revenue rose 14% to $168.8 million. Chief Executive Officer Vivek Jayaraman said the company’s kit sales in the quarter represented nearly 800,000 doses of transfusible blood components.

“Our third quarter performance reflects meaningful progress” across the company’s growth, innovation and financial priorities, Jayaraman said. He cited growth in core franchises, progress in transitioning the INTERCEPT fibrinogen complex, or IFC, business model, and international placements of the INT200 illuminator.

North American Growth and IFC Transition

North American product revenue increased 12% year over year and accounted for more than two-thirds of third-quarter product revenue. Kevin Green, Cerus’ chief financial officer, said North American platelet kit volume and calculated platelet doses increased 5% from a year earlier, which he said outpaced underlying platelet-market growth.

The company pointed to its nationwide agreement with Blood Centers of America, whose members distribute more than half of U.S. blood products, as a contributor to adoption. Jayaraman said revenue growth from BCA member blood centers exceeded overall North American growth through the first three quarters of the year.

IFC product revenue was $5.6 million in the third quarter, compared with $3.9 million a year earlier. Cerus is moving its IFC business away from direct sales of finished therapeutic products to hospitals and toward kit sales to blood centers, which then produce and distribute IFC to hospital accounts.

Of total IFC sales shipped in the quarter, 90% were kits, Green said. While kit sales carry lower selling prices than finished biologics, the company said the kit model provides a more favorable gross-margin profile and expands access through blood center distribution networks. Cerus expects essentially all IFC sales to be in kit form by 2027.

On a dose-equivalent basis, IFC volume rose 7% sequentially. Jayaraman said immediate access to fibrinogen and a five-day post-thaw shelf life are supporting hospital demand, while the broader BCA network and peer-to-peer clinical education are helping the company expand use.

International Results Face Geopolitical and Currency Headwinds

EMEA product revenue increased 5% as reported from the prior-year period. The company said the result reflected continued placement of its LED-based INT200 illuminator, though revenue was affected by lower Russian orders amid the Russia-Ukraine conflict, deferred orders from France’s EFS blood service and foreign-exchange pressure.

Green said unfavorable currency exchange rates reduced reported EMEA growth by roughly 2%. Jayaraman described the geopolitical and currency pressures as near-term and transient, while saying the company’s market position and demand for INT200 remain encouraging.

“The underlying impact in terms of long-term belief in the technology and the strength of our product remains unchanged,” Jayaraman said during the question-and-answer session.

RedeS Study Meets Primary Efficacy Endpoint

Cerus also reported positive top-line findings from its Phase III RedeS study, which evaluated INTERCEPT-treated red blood cells against conventional red blood cells in patients requiring acute and chronic transfusion support.

The trial met its primary efficacy endpoint by demonstrating non-inferiority in adjusted hemoglobin increment, a measure of red blood cell transfusion effectiveness. The company also said there was no statistically significant difference between treatment-emergent adverse events in the treatment and control groups, including INTERCEPT red-blood-cell-specific antibodies observed in the treatment arm. Cerus said those antibodies were consistent with prior studies and had no clinical impact.

The company plans to complete a full clinical analysis in the coming months. Jayaraman said the full data analysis, clinical study report and regulatory submissions are expected to support future discussions with the U.S. Food and Drug Administration. Secondary endpoints have not yet been reported, he said.

For Europe, Cerus is responding to questions from France’s ANSM concerning its CE mark application for red blood cells. The company plans to include the full RedeS clinical study report in that submission and now expects CE mark clearance in late 2027. If approved, Cerus plans a limited European market release at selected centers of excellence before pursuing a broader commercial strategy.

Separately, the company received preliminary FDA questions on its PMA submission for the INT200 platelet illuminator. Cerus said it believes the questions are addressable but expects to collect additional data before it can gain clearer visibility into approval timing.

Profitability and Outlook

Cerus reaffirmed full-year 2026 product revenue guidance of $229 million to $231 million, including IFC sales of $23 million to $25 million.

• Third-quarter product gross margin was 52.4%, compared with 53.4% a year earlier and 51.4% in the second quarter.
• Operating expenses were $36.2 million, up 5% year over year.
• GAAP net loss attributable to Cerus was under $1 million, approaching break-even.
• Non-GAAP adjusted EBITDA was $5.7 million, compared with $5 million a year earlier, marking the company’s 10th consecutive positive adjusted EBITDA quarter.
• Cash generation from operations was $3 million, and cash, cash equivalents and short-term investments totaled $57.1 million at Sept. 30.

Green said the company has “line of sight into achieving GAAP profitability.” Cerus also said it intends to refresh its shelf registration statement as its existing registration is scheduled to expire, though Green noted the company has not used the shelf since 2021.

About Cerus (NASDAQ:CERS)

Cerus Corporation is a biomedical products company focused on improving the safety of blood transfusions. Headquartered in Concord, California, the company develops and commercializes technologies designed to reduce the risk of transfusion-transmitted infections and other threats to the blood supply.

Its principal product platform is the INTERCEPT Blood System, which uses pathogen-reduction technology to treat donated blood components. The system is available for platelets and plasma in multiple markets and is designed to inactivate a broad range of viruses, bacteria, parasites and other pathogens.

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