Cinclus Pharma (CINPHA) Q4 2024 earnings summary

Executive summary

• Linaprazan glurate received its first marketing approval for GERD in China, following a successful Phase III trial by partner Sinorda, marking a major milestone and reducing development risk for other regions.

• PCABs are rapidly replacing PPIs in global markets, with strong uptake in Asia, Mexico, India, and at least 19 countries having active sales.

• Regulatory alignment achieved with EMA and FDA on pediatric study plans for eGERD, supporting global development.

• Preparations for pivotal Phase III trials in the U.S. and Europe are underway, targeting superiority in healing and symptom control over PPIs.

Financial highlights

• Cash and cash equivalents at year-end were SEK 567 million (TSEK 566,716), up significantly due to a SEK 750 million share issue and IPO proceeds.

• Q4 2024 net sales were SEK 4.6 million, flat year-over-year; full year net sales SEK 6.0 million, down SEK 1.4 million from 2023, mainly from China milestone payments.

• R&D expenses made up 88% of Q4 operating expenses, reflecting the ramp-up for Phase III; full year R&D SEK 136.7 million, down SEK 30 million from 2023.

• Q4 2024 EBIT loss was SEK -56.9 million; full year EBIT loss SEK -169.6 million, improved by SEK 31.3 million year-over-year.

• Total cash flow for the year was SEK 477 million positive, compared to SEK -86.3 million in 2023.

Outlook and guidance

• First patient recruitment for the Phase III eGERD trial in the U.S. and Europe is expected in Q3 2025, with top-line results targeted for 2026.

• Financial runway is expected to cover operations through the 2026 readout.

• No revenue from China commercialization is expected until 2026 due to ongoing pricing and reimbursement processes.

• The company aims to launch its product globally by 2029, focusing on differentiation and superiority over existing therapies.

• Ongoing evaluation of additional financing options to accelerate development or expand indications.