Release Date: August 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Total revenue increased by 13% to $42.5 million for the second quarter compared to the same period in 2023.
- Adjusted EBITDA for the second quarter rose by 51% to $9.1 million.
- Strong cash flow with $15 million provided by operating activities in the first half of 2024.
- Maintained a strong balance sheet with approximately $56.6 million in cash at the end of the second quarter.
- Significant progress in the ongoing Phase 3 pivotal trial for inhaled AAT therapy, targeting a $2 billion market.
Negative Points
- Operating expenses increased by 11% over the prior year period, totaling $26 million for the first six months of 2024.
- Enrollment for the Phase 3 InnovAATe clinical trial is only around 40% to 45%, indicating potential delays.
- The company has not yet received feedback from the FDA on the revised statistical analysis plan for the inhaled AAT therapy.
- The competitive landscape for enrollment in the inhaled AAT therapy trial is challenging due to other players in the market.
- No current plans to pay dividends as the focus remains on M&A and business development transactions.
Q & A Highlights
Q: Can you provide an update on the inhaled AATD program, including any feedback from the FDA and the impact on trial timing?
A: We submitted a revised statistical plan to the FDA in Q2 and expect feedback by year-end. Enrollment is around 40-45%, and we aim to complete it by the end of next year. The potential reduction in patient numbers could shorten recruitment by a few months.
Q: What is the current status of CYTOGAM in CMV, and are there any updates on guidelines for its use in high-risk patients?
A: We are collaborating with US KOLs on data collection and studies to demonstrate CYTOGAM's benefits. The consensus document is under periodic review, and our efforts since 2023 have shown positive results in CYTOGAM sales.
Q: Are you seeking a global commercialization partner for the AAT program, or are you considering regional partnerships?
A: We are primarily focused on the US and European markets, which could involve one partner for both territories or separate partners for each.
Q: Are you open to in-licensing earlier-stage assets, or is the focus on commercial-stage products?
A: Our focus is on commercial-stage or near-commercialization-stage products to support our commercial growth, leveraging the success of our previous M&A activities.
Q: With positive cash flow ramping up, is there any consideration for paying a dividend in the future?
A: While paying a dividend could be an option in the future, our current focus is on using generated funds for M&A and business development to continue growing the business.
Q: What is your current market share of KEDRAB, and what are your future expectations?
A: KEDRAB holds a 40-50% market share in the US, and we believe it can grow beyond 50%. We have a $180 million guaranteed revenue commitment over the next four years, with potential for further growth.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
