Sam

Sam asked why the 2026 MACI growth guidance, at an 18% midpoint, is slightly below the 20% mentioned in the Q3 2025 earnings call, especially given the strong Q4 performance.

Answer

Joe Mara, Vericel's Chief Financial Officer, clarified that nothing materially changed and the year-end was stronger than expected. He explained that the guidance is prudent, consistent with prior commentary, and aligns with consensus, emphasizing a balanced guide with similar incremental growth year-over-year and a strong Q1 start exceeding 20% total company growth. He also noted that the guidance does not bake in outperformance from the new sales force or potential BARDA revenue.

Sam asked for more details on the two lower doses being tested in the CIC trial, noting their potentially lower efficacy in IBS-C, and questioned if the strategy involves offering multiple dose options or finding one optimal dose for CIC.

Answer

Chief Patient Officer and Interim Chief Medical Officer Laura Williams explained the trial design includes a lowest dose for evaluation, a middle dose (25mg BID) for the less difficult CIC condition, and the 50mg BID dose, which showed efficacy in TEMPO. CEO Mike Raab emphasized that the company will follow the data to determine the optimal path forward.

Sam, on behalf of Chris from Raymond James Financial, Inc., inquired about the two lower doses being tested in the CIC trial, specifically asking about expectations for their performance given they were less efficacious in IBS-C, and whether the strategy aims for multiple dose options or one optimal dose.

Answer

Chief Patient Officer and Interim Chief Medical Officer Laura Williams explained that the lowest dose is included to evaluate the least effective dose, while the 25mg BID dose is considered appropriate for CIC, which is a less difficult condition to treat than IBS-C. The 50mg dose, used in TEMPO, provides a strong basis. CEO Mike Raab added that the company will follow the data from the three different doses to determine the path forward.

Sam asked if Agree Realty's exposure to lower-income consumers, particularly through dollar stores, off-price retail, and discount stores, presents any downside risk, and what measures the company is taking to mitigate such risks.

Answer

President and CEO Joey Agree described the current economic environment as a 'trade-down effect,' where the middle-income consumer is facing significant challenges due to cumulative inflation. He noted that consumers are increasingly seeking bargains and discounts, leading to strong performance from retailers like Five Below, Dollar General, and Walmart. Mr. Agree stated that Agree Realty's focus on necessity-based goods and services, or operators with a unique value proposition, inures to their benefit in this environment, as they avoid luxury, experiential, and 'fun' retail sectors.

Sam inquired about the expected cadence of deals for Ventas for the remainder of the year.

Answer

Robert F. Probst, EVP and CFO, advised modeling the cadence of deals over the course of the year as ratable.

Sam inquired about any updates on PAX, specifically seeking insight into the outcome of the federal investigation.

Answer

CIO Vikas Gupta stated that Omega has no more public information on the PAX investigation but confirmed close contact with PACS management, noting strong performance, good credit, operating results, and clinical performance of their buildings at Omega. Sam also asked about the timing and expected returns for redeploying proceeds from Genesis-related loans in 2026. CFO Bob Stephenson clarified that $137 million in Genesis loans (DIP and term loan) are assumed to be repaid mid-year, with proceeds first paying off credit facility balances, and the remainder invested at approximately 3.5% overnight rates.

Sam, on behalf of James Shin, asked for more details on the data expected at ASH, specifically regarding the pediatric ALL study, the Carlyle study in SLE, and analyses from the FELIX study.

Answer

Dr. Christian Itin, CEO of Autolus Therapeutics, detailed that the pediatric ALL study poster would present phase one experience from approximately 20 patients, including longitudinal safety and response data. The Carlyle study oral presentation would expand on ACR data with additional pharmacodynamic recovery. FELIX study presentations include an oral presentation on product cell phenotypes linked to long-term outcomes and a poster on CAR-T cell persistence at three months as a predictor of outcome.