Release Date: July 31, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Okedi, Risperidone ISM, sales increased by 141% compared to the first half of 2023, reaching EUR12.5 million.
- Gross margin improved by 280 basis points to 59.4% due to higher-margin contributions from existing CDMO customers and Okedi sales.
- ROVI's subsidiary entered into an agreement to manufacture pre-filled syringes, expected to positively impact revenue by 20% to 45% over 2023 sales starting in 2027.
- Bemiparin sales grew by 6%, with international sales increasing by 32%, driven by strong performance in China, Turkey, and Greece.
- ROVI received European approval for a new sodium heparin plant, enhancing production capacity for essential medicines.
Negative Points
- Operating revenue decreased by 14% to EUR329.3 million, primarily due to lower COVID-19 vaccine manufacturing revenues.
- EBITDA decreased by 28% to EUR69.9 million, with a 4.3 percentage point decline in the EBITDA margin.
- Net profit fell by 32% to EUR44.3 million in the first half of 2024.
- Sales of low molecular weight heparins decreased by 2%, mainly due to lower orders from enoxaparin partners.
- CDMO sales declined by 31% due to reduced COVID-19 vaccine manufacturing and preparation activities under the Moderna agreement.
Q & A Highlights
Q: When do you expect to provide more details about the strategy to enter the US market with Risvan, and when is the product launch expected?
A: The approval of Risvan is a significant milestone for ROVI, marking the validation of our platform by the FDA. We are currently gathering market data and understanding the rationale behind the discontinuation of Perseris. We aim to announce our strategic decision before the end of the year. - Juan Lopez-Belmonte Encina, CEO
Q: What is your view on the discontinuation of Perseris marketing in the US?
A: We speculate that the discontinuation may be due to financial constraints and perceived lower efficacy. Unlike Perseris, ROVI owns its ISM technology, which offers better efficacy and no need for loading doses. - Juan Lopez-Belmonte Encina, CEO
Q: Do you anticipate fully allocating the ongoing capacity expansion in the CDMO business soon?
A: The CDMO injectable market is growing rapidly, and we are optimistic about filling our current and new capacities. The acquisition of Catalent by Novo Nordisk may create additional opportunities for us. - Javier Lopez-Belmonte Encina, CFO
Q: How are you seeing the vaccination campaign this year, and are you optimistic about potential new contracts impacting 2024 figures?
A: It's early to predict the campaign's outcome, but we are optimistic about Moderna's preparations. We see vaccination fatigue but expect more visibility and potentially better news in the coming weeks. - Javier Lopez-Belmonte Encina, CFO
Q: Is a low double-digit growth in SG&A a good reference for the second half of the year?
A: We expect a slight increase in SG&A in the second half, potentially a high single-digit growth, due to anticipated growth in the CDMO business and vaccination campaigns. - Javier Lopez-Belmonte Encina, CFO
Q: Can you clarify if the EUR200 million to EUR300 million for Risvan refers to your sales, and would in-market sales be much higher?
A: The EUR200 million to EUR300 million refers to our sales of the product. We are enthusiastic about the market acceptance in Europe, and initial feedback is very positive. - Juan Lopez-Belmonte Encina, CEO
Q: What update can you give on the CDMO strategic review, and when could we expect an outcome?
A: We have received nonbinding offers for our CDMO business, and the process is ongoing. Any decision will be subject to shareholder approval and regulatory clearances. - Javier Lopez-Belmonte Encina, CFO
Q: Do you expect more large contracts like the one announced earlier this year, or are you focusing on smaller contracts and a diversified client base in CDMO?
A: We are exploring both large and small contracts. The acquisition of Catalent by Novo Nordisk presents a significant opportunity, and we are preparing to capture as much of it as possible. - Juan Lopez-Belmonte Encina, CEO
For the complete transcript of the earnings call, please refer to the full earnings call transcript.