• Revenue: $112.2 million net product revenue for Q3 2024, a 73% year-over-year growth.
• Arcalyst Net Sales Guidance: Increased to $410 million to $420 million for full year 2024.
• Arcalyst Collaboration Operating Profit: $58.2 million, a 68% year-over-year growth.
• Total Collaboration Expenses: $29.3 million.
• Net Loss: $12.7 million for Q3 2024, compared to $13.9 million in Q3 2023.
• Net Cash Flow: $5 million for Q3 2024.
• Cash Balance: $223.8 million at the end of Q3 2024.
• Total Prescribers: Increased from approximately 2,300 in Q2 to approximately 2,550 in Q3.
• Repeat Prescriber Rate: Approximately 25% of prescribers since launch writing multiple prescriptions.
• Patient Compliance: Above 85%.
• Payer Approval Rate: Greater than 90% for completed cases.

• Warning! GuruFocus has detected 3 Warning Sign with BP.

Release Date: October 29, 2024

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

Positive Points

• Kiniksa Pharmaceuticals International PLC (NASDAQ:KNSA) reported a 73% year-over-year growth in Arcalyst net product revenue, reaching $112.2 million for the third quarter.
• The company increased its full-year Arcalyst net sales guidance to between $410 million to $420 million, up from the previous range of $405 million to $415 million.
• Kiniksa Pharmaceuticals International PLC (NASDAQ:KNSA) has a robust financial position with a positive annual cash flow, supporting growth investments across its business.
• The company has seen an increase in total prescribers from approximately 2,300 in Q2 to approximately 2,550 in Q3, indicating strong market penetration.
• Patient compliance remains high at above 85%, with greater than 90% payer approval of completed cases, reflecting strong satisfaction with Arcalyst.

Negative Points

• Despite the growth, Kiniksa Pharmaceuticals International PLC (NASDAQ:KNSA) reported a net loss of $12.7 million for the third quarter of 2024.
• The company faces challenges in penetrating the market for first recurrence patients, with only 15% of prescriptions coming from this group.
• There is a significant delay in diagnosis for recurrent pericarditis, with patients reporting an average of 2.7 misdiagnoses before receiving the correct diagnosis.
• Operating expenses have increased due to costs associated with Arcalyst revenue growth, collaboration expenses, and R&D and SG&A driven largely by personnel costs.
• The company has not provided specific guidance on enrollment timelines for the Abiprubart phase two B study in Sjogren's disease, indicating potential uncertainties in clinical development.

Q & A Highlights

Q: Can you discuss the penetration of Arcalyst in the market for first recurrence patients and how you plan to drive further penetration? A: Ross Moat, Chief Commercial Officer, explained that while the primary focus is on patients with two or more recurrences, there is growing interest in treating first recurrence patients. This is due to the broad label of Arcalyst and its efficacy in preventing future flares. The company continues to focus on disease education and aims to penetrate all recurrence groups within their label.

Q: How should we think about the growth rate for Arcalyst moving forward, particularly in the fourth quarter and next year? A: Ross Moat noted that while it's uncertain if they are reaching a steady state in growth, the company is intent on continued growth. They have increased their full-year sales guidance due to strong performance, indicating a positive outlook for future growth.

Q: What were the gross-to-net figures for the quarter? A: Mark Ragosa, Chief Financial Officer, stated that the year-to-date gross-to-net through the third quarter was 9.8%, down from 10.8% in the second quarter.

Q: Can you provide insights into the duration of therapy for patients on Arcalyst, particularly those on their first recurrence versus those with multiple recurrences? A: John Paolini, Chief Medical Officer, explained that the median duration for patients with two or more recurrences is three years, while for first recurrence patients, it is six months. However, some first recurrence patients with aggressive disease may require longer treatment.

Q: Are there any trends in prescribing Arcalyst earlier in the disease course among repeat prescribers? A: Ross Moat mentioned that prescribing trends are scattered across the board, with no specific correlations noted. The company is focusing on initiatives to improve early diagnosis and treatment pathways, such as partnering with the American Heart Association to streamline referral pathways.

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