Release Date: May 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Talphera Inc (TLPH, Financial) has successfully finalized clinical trial agreements with five large academic institutions for the NEPHRO CRRT study, with plans to finalize agreements with five more.
- The company has received positive feedback from principal investigators, who are confident about rapid enrollment due to high patient availability for the study.
- Manufacturing processes for Niyad have met specifications, and Talphera Inc (TLPH) is collecting extended stability data to support commercial launch.
- Additional market research has reinforced the strong safety profile of nafamostat, particularly for patients with liver impairment, supporting its competitive market positioning.
- Talphera Inc (TLPH) secured $18 million in funding from existing investors and an additional $8 million from partial monetization of disputed royalty and milestone streams, enhancing financial stability.
Negative Points
- There has been a delay in the initial enrollment for the NEPHRO CRRT study, which may affect the timeline for top-line data availability and subsequent PMA filing.
- No revenues were recorded during the first quarter as all severe royalties and milestones will now be paid to Xoma until they reach their agreed return.
- The company recorded a $6.3 million liability related to the Xoma royalty transaction, despite no obligation to repay the proceeds.
- Operational expenses, while lower than the previous year, are expected to increase as the clinical trial progresses.
- The company faces potential challenges in rapid study enrollment and execution due to administrative and staffing issues at large academic institutions.
Q & A Highlights
Q: On the timeline delay, can we reasonably assume top-line results this year?
A: Vincent Angotti, CEO of Talphera Inc, mentioned that while there are no significant delays expected, better guidance will be provided in the next earnings call. Dr. Pamela Palmer highlighted the large capacity of the academic institutions involved, which supports rapid enrollment and potentially achieving top-line results within the year.
Q: Can you quantify the opportunity size in CRRT, especially with the increase since COVID?
A: Vincent Angotti clarified that the increase in CRRT procedures since COVID is meant to assure rapid study enrollment, not to suggest a continuous annual increase. The market for CRRT remains robust with an estimated 165,000 patients, supporting a $100 million peak sales potential for Niyad in CRRT.
Q: Regarding the cost of Niyad, can you provide a range or estimate compared to the total cost of citrate anticoagulation?
A: Raffi Asadorian, CFO, indicated that Niyad is expected to be priced competitively, between parity and a 10% premium over the cost of citrate, which includes additional costs like calcium infusion and monitoring. The estimated price range for Niyad is around $47 to $49 per vial.
Q: What are the main reasons for the delay in the NEPHRO trial?
A: Dr. Pamela Palmer explained that the delays are primarily due to understaffing in budgeting and contracting offices at large institutions, along with the need for nurse education and pharmacy adjustments for new investigational products. Despite these challenges, there is strong enthusiasm from principal investigators, suggesting swift progress once initial hurdles are overcome.
Q: How will operational expenses change as the trial progresses through 2024?
A: Raffi Asadorian noted that while Q1 operational expenses were $3.9 million, the full-year expenses are expected to be between $21 million and $22 million, reflecting increased activity as the clinical study advances.
Q: Can you provide insights into the potential market share of Niyad compared to citrate and heparin in CRRT?
A: Vincent Angotti discussed that feedback remains consistent with previous estimates, with Niyad potentially replacing a significant portion of the citrate and heparin markets in CRRT. The simplicity and safety profile of Niyad compared to existing treatments are highly valued by healthcare professionals, supporting a strong market entry potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
