Justin Smith

Justin Smith from Bernstein sought clarification on the validity of Grifols' 2029 guidance, asking if it remained applicable on an absolute basis with only a euro-dollar FX adjustment, and whether the growth trajectory was 'hockey stick' or if structural changes had occurred in the past year.

Answer

CFO Rahul Srinivasan affirmed that the core objectives of the 2025-2029 roadmap—increasing EBITDA, improving margins, expanding free cash flow, and deleveraging—remain fully intact. He highlighted that Grifols met its 2025 guidance and is on track for 2027 milestones, emphasizing moderate growth from a higher base after significant expansion in recent years.

Justin Smith sought clarification on the validity of Grifols' 2029 guidance, asking if it remains structurally unchanged after adjusting for the euro-dollar exchange rate shift from 1.04 to 1.12, or if any fundamental changes have occurred.

Answer

CFO Rahul Srinivasan affirmed that the core objectives of the 2025-2029 roadmap—increasing EBITDA, improving margins, expanding free cash flow, and deleveraging—remain fully intact. He highlighted the achievement of 2025 guidance, the provision of 2026 guidance, and being on track for 2027 milestones, emphasizing moderate growth from a higher base.

Justin Smith asked for commentary on switching patients off subcutaneous IG onto VYVGART and how that dynamic has changed over the last three months.

Answer

Karen Massey, Chief Operating Officer, clarified that the FDA review into real-world evidence regarding switching from IVIG to VYVGART and potential CIDP worsening has been completed. The label has been updated with helpful guidance for healthcare professionals, reinforcing the ADHERE data and VYVGART's risk-benefit profile.

Justin Smith asked about the commentary regarding switching off subcutaneous IG onto VYVGART and how that has changed over the last three months.

Answer

Karen Massey, COO, reported positive news that the FDA review into real-world evidence around switching and CIDP worsening has been completed. The label has been updated with helpful guidance for HCPs on switching from IVIG to VYVGART, reinforcing the known risk-benefit profile.

Justin Smith inquired about the powering of the CARDIO-TTRansform study for Wainua, specifically whether the monotherapy versus combination with TAF arm is sufficiently powered to demonstrate clinically meaningful results.

Answer

Sharon Barr, EVP, BioPharmaceuticals R&D, AstraZeneca, stated that CARDIO-TTRansform, the largest-ever cardiomyopathy study, is powered for preplanned subgroup analyses, including differentiation between patients on baseline tafamidis versus those not. She emphasized its design to inform treatment guidelines and shape future cardiomyopathy care.

Justin Smith asked about the powering of the CARDIO-TTRansform study for Wainua, specifically concerning its ability to differentiate between monotherapy and combination with tafamidis (TAF) and to demonstrate clinical meaningfulness for the TAF combo arm.

Answer

Sharon Barr, EVP, BioPharmaceuticals R&D, stated that CARDIO-TTRansform is the largest-ever cardiomyopathy study, powered for preplanned subgroup analyses, including patients on baseline tafamidis. This design aims to inform treatment guidelines and demonstrate additive benefit.

Justin Smith asked about the potential for the CARDIO-TTRansform study to reshape treatment guidelines for ATTR amyloidosis and the development of simpler diagnostic tests to expand the cardiomyopathy patient population.

Answer

EVP of Biopharmaceuticals R&D Sharon Barr expressed anticipation for the CARDIO-TTRansform readout in 2026, highlighting its potential to guide treatment decisions and the company's unique position with a depleter and silencer in its portfolio. She also discussed exploring AI-informed models and new biomarker assays for earlier diagnosis. EVP of Biopharmaceuticals Business Unit Ruud Dobber emphasized the trial's significance as the largest CM trial to date.

Justin Smith asked about WAINUA (iplantosin), specifically if the CARDIO-TTRansform trial could reshape long-term treatment guidelines and whether new, simpler diagnostic tests are emerging to expand the cardiomyopathy patient population.

Answer

EVP of Biopharmaceuticals R&D Sharon Barr discussed CARDIO-TTRansform's potential to demonstrate the role of silencers and compare iplantosin with tafamidis, noting ALXN2220 for combination approaches. She also mentioned efforts in earlier diagnosis via AI models and biomarker assays. EVP of Biopharmaceuticals Business Unit Ruud Dobber highlighted it as the largest CM trial, with hopes for a CV mortality benefit.

Justin Smith requested more color on the increased competition for Ultomiris, asking if it was price-related and how it aligns with competitors' views that innovation should expand the market.

Answer

EVP, Rare Disease, Marc Dunoyer clarified that the competition for Ultomiris comes primarily from novel medicines with different mechanisms of action, not biosimilars or price pressure. He agreed that innovation is expanding the myasthenia gravis market, where Ultomiris holds a key position, but other novel therapies are also attracting patients new to branded treatments.

Justin Steven Smith of Bernstein asked about the rare disease drug efzimfotase, specifically its cost of goods compared to Strensiq, and also inquired about the outlook for capital expenditures beyond 2025.

Answer

Marc Dunoyer, EVP of Rare Disease, confirmed that the cost of goods for efzimfotase is significantly lower than for Strensiq, which will help support the goal of reaching a much larger patient population. CFO Aradhana Sarin stated that the current elevated level of CapEx should be expected for the next several years, as it supports multiyear manufacturing and technology projects already underway.

Justin Steven Smith of AllianceBernstein asked about the resonance of the Minimal Residual Disease (MRD) endpoint in the DREAMM-10 first-line trial for Blenrep with payers and community doctors, particularly outside the U.S.

Answer

An executive, likely Chief Scientific Officer Tony Wood, explained that MRD is a newer endpoint recommended by ODAC, with the goal of establishing its correlation with established endpoints like PFS over time. CCO Luke Miels added that market research indicates physicians view MRD as a practical necessity for long first-line trials, but it does not replace overall survival data in later lines of therapy, where Blenrep has demonstrated strong results.

Inquired about the operational details at the Orlando facility, including the types of testing, the status of customer demonstrations, and key metrics for customers. Also asked about the timeline for the Orange County Sanitation unit's shipment.

Answer

The executive confirmed the Orlando facility is fully operational, currently focusing on biosolids processing while also conducting customer demonstrations. Customers are focused on system stability and the complete destruction of waste, particularly hard-to-destroy short-chain PFAS. The Orange County unit will be shipped after a one-day factory acceptance test.