Inventiva SA (IVEVF) (Q4 2024) Earnings Call Highlights: Navigating Financial Challenges and ...

GuruFocus.com
28 Mar
  • Cash Position: $96.6 million at the end of 2024, up from $36 million at the end of December 2023.
  • Revenue: $9.2 million in 2024, compared to $17.5 million in 2023.
  • R&D Expenses: $19.9 million in 2024, a decrease of 17% from 2023.
  • G&A Expenses: $15.8 million in 2024, up 14% from 2023.
  • Net Financial Loss: $86 million in 2024, compared to $5 million in 2023.
  • Net Loss: $184.2 million for the full year 2024, compared to $110.4 million in 2023.
  • Financing Raised: Approximately $184 million in gross proceeds through various operations.
  • Warning! GuruFocus has detected 7 Warning Signs with IVEVF.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

  • Inventiva SA (IVEVF) made significant progress in the clinical development of lanifibranor, closing screening for Phase 3 NATiV3 early in January 2025.
  • The company received positive recommendations from three data monitoring committee meetings to continue the NATiV3 trial without modifications.
  • Inventiva SA (IVEVF) reinforced its clinical data set for lanifibranor with positive results from the LEGEND trial, showing significant improvements in HbA1c and liver injury markers.
  • The company successfully raised approximately $184 million in gross proceeds through various financing operations, strengthening its financial position.
  • Inventiva SA (IVEVF) expanded its governance by appointing experienced board members, including Mark Pruzanski, enhancing its strategic capabilities.

Negative Points

  • Inventiva SA (IVEVF) decided to halt all preclinical activities not related to lanifibranor, resulting in a workforce reduction of approximately 50%.
  • The company reported a net loss of $184.2 million for the full year 2024, compared to $110.4 million in 2023.
  • R&D expenses decreased by 17% in 2024 due to operational delays, impacting the company's development timeline.
  • The company faces potential challenges in securing additional financing to support its long-term objectives beyond the current cash runway.
  • Inventiva SA (IVEVF) needs to manage the potential weight gain associated with lanifibranor, which may require combination treatments to mitigate this side effect.

Q & A Highlights

Q: Are the background doses for patients on GLP-1s low dose diabetic doses, or do they include high doses for weight loss? How many patients are enrolled on background SGLT2 inhibitors? A: The GLP-1 doses are mostly anti-diabetic, including semaglutide and other GLP-1 agonists. Approximately 6 to 8% of patients are on SGLT2 inhibitors at baseline. - Frederic Cren, CEO

Q: What is your confidence level in completing enrollment by April 30 to secure the EUR116 million capital increase? What are the plans for additional financing? A: Confidence is high as we have sufficient patients already randomized and in screening to meet our target. We are actively managing financial resources and evaluating options to secure funding for clinical trials and commercialization. - Frederic Cren, CEO

Q: Are there any specific rate-limiting steps in screening that could affect the last patient's enrollment? How do you see the market evolving with the introduction of lanifibranor? A: The screening process involves lab tests and biopsies, which take 8 to 12 weeks. We are confident in meeting our enrollment target. Lanifibranor is ideal for patients with advanced fibrosis and type 2 diabetes, a large and underserved population. - Frederic Cren, CEO

Q: What are the expected R&D expenses and potential milestone payments for this year? A: R&D expenses are expected to increase by 10% to 20% as we prepare for NDA filing and commercialization. We anticipate receiving the second $10 million milestone from our Chinese partner CTTQ after the last randomization disclosure. - Jean Volatier, CFO

Q: How soon after the last patient completes treatment will you share top-line data, and how does this align with your cash runway? A: We expect to publish top-line data a couple of months after the last patient's last visit. With the second tranche of financing, we will have the means to deliver on our clinical objectives. - Frederic Cren, CEO

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.

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