Matthew

Matthew asked if current Matrix-M agreements also apply to the portfolio of new adjuvants and different formulations of Matrix-M that Novavax is developing. He also inquired if one of the three pipeline programs (C. diff, shingles, RSV) is ahead of the others, or if the selection for clinical advancement depends on therapeutic area developments.

Answer

Chief Strategy Officer Elaine O'Hara clarified that all current signed agreements and MTAs focus exclusively on Matrix-M. CEO John Jacobs added that any new adjuvants developed would be Novavax's IP and could be out-licensed separately, as Matrix-M has not been exclusively licensed. Head of R&D Ruxandra Draghia explained that each early pipeline asset addresses a different unmet medical need and has its own complexities, with rigorous target product profiles evolving with the ecosystem. The selection for advancement considers competitive landscape, opportunity, and internal data generation.

Matthew inquired whether Rhythm Pharmaceuticals would be able to supplement its Acquired Hypothalamic Obesity (HO) data package for FDA review with the Japanese cohort data, and if the timing would allow for its inclusion before the PDUFA date.

Answer

David Meeker, Chairman, CEO, and President, confirmed that the Japanese cohort data would be included in the FDA submission. He explained that the FDA was aware of the timing when granting the PDUFA extension in November, ensuring sufficient time to incorporate the data from the last Japanese patient before the March 20th PDUFA date.

Matthew, on behalf of Paul Matteis, asked if Rhythm Pharmaceuticals would be able to supplement its Acquired Hypothalamic Obesity (HO) data package for FDA review with data from the Japanese cohort, and if the timing would allow for its inclusion before the PDUFA date.

Answer

David Meeker, Chairman, CEO, and President, confirmed that the Japanese cohort data would be included in the FDA submission. He explained that the FDA was aware of the tight timeline between the last patient visit in Japan and the submission of data for all 142 patients, and is prepared to manage the review process ahead of the March 20th PDUFA date.

Matthew asked about the proportion of sales from existing versus new Cartrack customers and requested examples of Cartrack Tag use cases. He also inquired about regulatory or technical issues for Tag rollout in new markets.

Answer

Zak Calisto, Founder and Group CEO, explained that net additions primarily represent new customers, while sales to existing customers typically involve full fleet adoption or new vehicle purchases not reflected in net additions. He described Cartrack Tag's use cases as tracking equipment or vehicles outside the GSM network. He stated that no such issues have been encountered in the markets where they are currently rolling out, though he acknowledged that regulations vary by country.

Matthew (on behalf of Paul Matteis) asked if the multiple cartons per shipment indicated stockpiling behavior among patients due to EKTERLY's convenience and easier storage, and how this behavior might evolve in the future.

Answer

Ben Palleiko (CEO) stated that the company doesn't factually know about stockpiling but noted high self-reported attack rates among current users. He expects usage, refill frequency, and volumes to normalize as EKTERLY's adoption expands to a broader patient population. Nicole Sweeny (Chief Commercial Officer) added that treatment guidelines encourage patients to keep multiple doses on hand.

Matthew, on behalf of Paul Matteis, asked for clarification on the multiple cartons per shipment, questioning if it indicates stockpiling behavior among patients and how this trend might evolve in the future.

Answer

Ben Palleiko, Chief Executive Officer, acknowledged that the company does not factually know if stockpiling is occurring but noted that high self-reported attack rates suggest high utilization. He expects usage, refill frequency, and volumes per refill to normalize as EKTERLY expands into the broader patient population. Nicole Sweeney, Chief Commercial Officer, added that treatment guidelines encourage patients to keep enough product on hand for two to three attacks.