Egetis Therapeutics AB (FRA:P0F) Q4 2024 Earnings Call Highlights: Navigating Revenue Decline ...

GuruFocus News

Thu, Feb 27, 2025, 12:04 AM 4 min read

Full Year Revenue 2024: 43.1 million Swedish krona, down from 57.6 million Swedish krona in 2023.
Q4 Revenue 2024: 10.88 million Swedish krona, down from 32.6 million Swedish krona in Q4 2023.
Results After Tax Q4 2024: 110.5 million Swedish krona, compared to negative 86.3 million Swedish krona in the previous year.
Operating Cash Flow Q4 2024: 53.6 million Swedish krona, up from 41.6 million Swedish krona in Q4 2023.
Cash Position End of 2024: 351 million Swedish krona, up from 303 million Swedish krona at the end of 2023.
Net Cash Injection Q4 2024: Approximately 281 million Swedish krona.

Warning! GuruFocus has detected 6 Warning Signs with FRA:P0F.

Release Date: February 26, 2025

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

Positive Points

Egetis Therapeutics AB (FRA:P0F) received full approval for Emcitate in Europe, marking a significant milestone for the company.
The European Thyroid Association issued guidelines recommending Emcitate as a long-term therapy, which supports its commercialization efforts.
New data presented at the European Thyroid Association showed that Emcitate treatment is associated with a threefold reduction in mortality risk.
The company submitted a patent application to the US Patent and Trademark Office, potentially extending market exclusivity.
Egetis conducted a successful directed share issue, raising approximately USD 30 million, strengthening its financial position.

Negative Points

Revenues for the full year 2024 decreased compared to 2023, partly due to one-time license income in the previous year.
The company faces complex and time-consuming pricing and reimbursement negotiations across 27 EU countries.
There are challenges in patient recruitment for the ReTRIACt study, with some dropouts due to family circumstances.
Operating expenses increased due to investments in commercial buildup and non-cash items, impacting financial results.
The company does not disclose specific patient numbers per country, which may limit transparency for investors.

Q & A Highlights

Q: Can you provide an overview of your targeted launch and reimbursement timelines in Germany and other EU4 markets? A: In Germany, we plan to follow the standard 12-month timeline for negotiating the final reimbursed price after submission. For the other EU4 countries, the pricing and reimbursement processes are less structured and may take 1 to 2 years. However, there are possibilities for funded sales in parallel through negotiations with local hospitals and regions.

Q: How many patients are currently on treatment in Germany and the EU4 markets? A: We do not disclose patient numbers per country. However, we have 230 patients in our managed access program, with the majority in Europe. Based on population, a significant portion is likely in the EU4 markets.

Q: Do you have patients lined up for the Q2 launch in Germany, and how will you handle pricing and reimbursement negotiations in the EU4? A: Yes, we have patients lined up in Germany, including those under the managed access program and newly identified patients. We have built a commercial and medical affairs infrastructure focusing on Europe, with people on the ground for pricing and reimbursement, supported by local consultants.

Q: How quickly do you expect patients in the early access program to translate into commercial revenues upon launch in the EU? A: Patients will transition from managed access to commercial sales once national reimbursement is secured. In Germany, this will happen immediately at launch in Q2. For France, Spain, and Italy, funded sales are possible in parallel with pricing and reimbursement processes.

Q: What is the status of the ReTRIACt study, and how is patient attrition impacting the trial? A: We have 11 patients who have completed the randomized treatment phase, with 3 more in the running period. We have experienced a few dropouts due to family circumstances, not study drug-related. Screening failures are mainly due to logistical challenges like travel.

Q: When will the initial price in Germany be available, and what is the status of the rare disease voucher program? A: The initial price in Germany will be publicly available at launch in Q2. Regarding the rare disease voucher program, the FDA continues to issue designations, and there is ongoing activity in Congress to potentially renew the program.

Q: How do you expect OpEx levels to change in 2025, considering the ReTRIACt study and commercial investments? A: We anticipate R&D costs to decline as the ReTRIACt study concludes, offset by increased commercial investments. We expect a moderate to flat uptick in total OpEx levels, but no substantial increase.

Q: What are your disease awareness activities in Germany, and how is patient identification progressing? A: We plan to attend approximately 10 congresses in Germany this year to engage with physicians and support patient identification. Germany is advanced in genetic testing, aiding in diagnosing patients with unclear conditions.

Q: Will you file the new drug application in the US in 2025? A: Yes, we plan to file the new drug application in the US in 2025.

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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