Release Date: May 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Rigel Pharmaceuticals Inc (RIGL, Financial) reported strong commercial demand for its two marketed products, Tavalisse ITP and Rezlidhia IDH1, with demand reaching new quarterly highs.
- The acquisition of Gavreto, an FDA-approved therapy for RET fusion-positive cancers, is expected to provide top line growth and leverage existing commercial and medical infrastructure.
- Rigel Pharmaceuticals Inc (RIGL) has strategic alliances with MD Anderson Cancer Center and Connect, enhancing the ability to evaluate Rezlidhia's potential in a cost and time-efficient manner.
- The company is well-positioned for financial breakeven with a focus on growing the commercial product portfolio and prudent clinical development.
- Rigel Pharmaceuticals Inc (RIGL) has made progress in integrating Gavreto into its commercial portfolio, with a smooth transition expected by July.
Negative Points
- The decline in net product sales from the previous quarter was primarily due to a decrease in Tavalisse bottles remaining in the distribution channel.
- The first quarter typically faces industry headwinds such as insurance co-pays and resets, and the Medicare donut hole, which can impact sales.
- There is a significant reliance on the successful commercialization and integration of Gavreto to drive future revenue growth.
- Inventory levels at distributors are variable, which can lead to fluctuations in reported net product sales from quarter to quarter.
- The company is still working towards financial breakeven, indicating ongoing financial pressures and the need for careful management of resources.
Q & A Highlights
Q: On the cash guidance, you're burning about $8 million a quarter. You're mentioning getting to breakeven and also investing in license unit and in-licensing activities. Can you just help us walk through the path to getting to breakeven as far as the existing burn and the revenue picture as well as the investment in the portfolio?
A: Dean Schorno, CFO, explained that while specific guidance on reaching financial breakeven hasn't been provided, the company expects revenue increases, particularly with the launch of Gavreto, which should become rapidly accretive given the modest associated SG&A and clinical spend. The overall strategy involves growing top-line revenue while maintaining a modest increase in operational expenses.
Q: Can you talk about how you're going to balance the current pipeline where each of these assets in itself could potentially be evaluated in other indications and then also the continued appetite for more of these bolt-on deals where which fit your pipeline? And maybe another way to ask it is like where do you see the company maybe in two years from now?
A: CEO Raul Rodriguez discussed the strategy of leveraging the existing commercial and medical infrastructure to manage the growth of current products like Tavalisse and Rezlidhia, and the integration of Gavreto. He highlighted the potential for conducting clinical trials and pursuing acquisitions without significantly increasing infrastructure costs, aiming for a robust growth trajectory over the next few years.
Q: Therefore, definitely based on the distribution channels inventory in 1Q, how should we think about this for the rest of the year? And how variable is it like you just showed the numbers with the 4Q levels, but is it really variable across quarters?
A: David Santos, CCO, noted that inventory levels can vary, particularly between Q4 and Q1 due to seasonal purchasing patterns. However, he expects less significant variability moving forward. He emphasized that while Q1 saw a unique drawdown in inventory, the company anticipates stable or growing inventory levels aligned with business growth.
Q: For Rezlidhia you had a nice uptake. So wondering what proportion of the sales were from new patients versus the existing patients, and then what needs to be done to better compete with Tavalisse [ITP fostamatinib disodium patients]?
A: David Santos explained that a significant portion of Rezlidhia's demand comes from existing patients, with new patient starts also contributing robustly to sales growth. He highlighted the strategic focus on differentiating Rezlidhia in the treatment landscape, particularly for patients previously treated with Venetoclax, by emphasizing its long duration of response and strong efficacy.
Q: Could you comment on the brain activity for Gavreto as well as your interest in glioma for -- but I'm just curious, could you comment on the if you have details on the brain plasma ratio, whether you have information on that for both of those drugs. Just curious how brain-penetrant are they each?
A: CEO Raul Rodriguez and CMO Lisa Rojkjaer addressed the brain penetration capabilities of Gavreto and olutasidenib, noting their therapeutic effects in clinical studies, including the ARROW study for Gavreto. They confirmed the drugs' ability to cross the blood-brain barrier, which is crucial for treating brain metastases and gliomas, although specific brain-plasma ratios were not provided.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.