Release Date: July 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- HUTCHMED (China) Ltd (HCM, Financial) reported a profit of $26 million in the first half of 2024, with oncology consolidated revenue reaching $168 million, on track to meet full-year guidance.
- The company achieved strong in-market sales of FRUZAQLA in the US, reaching over $130 million, indicating robust early uptake.
- HUTCHMED (China) Ltd (HCM) maintains a strong cash position of over $800 million, providing financial stability and flexibility for future investments.
- The company is advancing its global strategy with the launch of fruquintinib worldwide and plans to file for US approval of savolitinib with AstraZeneca later this year.
- The pipeline continues to grow with six NDAs or supplementary NDAs under review globally, including promising developments in gastric and endometrial cancer treatments.
Negative Points
- Despite strong sales in the US, there is no updated sales guidance from Takeda for fruquintinib, creating uncertainty about future revenue expectations.
- The regulatory approval process for fruquintinib in second-line gastric cancer in China is ongoing, with no clear timeline for approval.
- R&D expenditures have been reduced due to strategic reorganization, which may impact the pace of development for some early-stage programs.
- The competitive landscape in China remains fierce, posing challenges for maintaining market leadership and growth.
- The company has not provided specific guidance on the quarterly sales trajectory for fruquintinib in Europe and Japan, pending reimbursement decisions.
Q & A Highlights
Q: How do you see the data from the SAVANNAH trial, and who will lead the US submission for savolitinib?
A: AstraZeneca is leading the trial and will handle the NDA submission, with contributions from HUTCHMED. The data shows promising results, particularly in MET-driven populations, and we expect a readout later this year.
Q: Given the strong sales momentum of fruquintinib in the US, is there a chance to raise sales guidance, and what is the EU sales strategy?
A: While we are pleased with the US performance, Takeda has not updated the sales forecast. In Europe, we expect a potential launch by the end of the year, with country-specific pricing and reimbursement negotiations underway.
Q: Can you provide an update on the regulatory approval status of fruquintinib in second-line gastric cancer in China?
A: The NDA review is ongoing, and we anticipate a decision in Q3. We have submitted additional analyses to the CDE to support the application.
Q: What are the plans for sovleplenib's commercialization in China and its clinical trial plans in the US and EU?
A: We are preparing for the China launch and engaging in business development discussions. Internationally, we have initiated dose optimization studies in the US and EU, with ongoing patient enrollment.
Q: With the reduction in R&D expenditure, does this affect any early-stage programs?
A: Our portfolio prioritization is data-driven, and we continue to support promising programs. We may delay some projects, but we are investing in new initiatives like the menin inhibitor, which has best-in-class potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
