Swedish Orphan Biovitrum AB (BIOVF) reported a strong first quarter with a 23% growth in their strategic portfolio, excluding seasonal RSV products and discontinued ReFacto manufacturing revenues.
The company achieved a significant market share of 57% for Altuvoct in Germany within nine months of its launch.
The haematology segment showed robust growth, driven by products like Doptelet, Aspaveli, and the launch of Altuvoct.
Swedish Orphan Biovitrum AB (BIOVF) received FDA priority review for Gamifant in the US, with a PDUFA date set for late June.
The company is actively expanding its pipeline with promising developments in areas such as nephrology and chronic refractory gout.
Negative Points
Vonjo sales were negatively impacted by stocking issues and gross-to-net adjustments, leading to a 6% decline in revenues.
Immunology revenues declined by 21% due to the expected decline of Synagis and seasonal shifts in Beyfortus royalties.
The company faces competition for Aspaveli from new oral medicines, which could impact its market performance.
There is uncertainty regarding the launch of Altuvoct in France and the UK, with ongoing discussions needed for market entry.
Potential tariffs on pharmaceutical products could impact the company's operations, though the exact effects remain speculative.
Q & A Highlights
Q: Congratulations on Altuvoct achieving 57% market share in Germany. Will this adjust your expectations for Altuvoct's market share in the haemophilia A market across Europe? Can you share initial feedback from Switzerland and Spain? A: The 57% share includes Elocta, with the majority from Altuvoct. The launch in Switzerland looks promising, and Spain shows strong signals, though reimbursement processes are ongoing. The 57% share is ahead of expectations, initially set at 30-40%. We are optimistic about the product's potential in other territories.
Q: Sanofi mentioned lower immunization rates in the US during Q1. Has Sanofi quantified how much stock remains, and how does this affect your outlook for 2025? Also, what is your appetite for M&A given the rapidly deleveraging balance sheet? A: Our annual ambition for the product remains unchanged, as Sanofi has not revised their annual goals. Stock levels are typical, and we see growth opportunities due to low immunization rates last year. Regarding M&A, we are actively exploring opportunities that align with our portfolio and provide leverage.
Q: What are the gating factors for launching Altuvoct in France and the UK? Also, regarding Aspaveli competition, how should we think about the dynamics in PNH? A: In the UK, we are operationalizing following a positive NICE outcome. In France, discussions with the Transparency Commission are ongoing, with a launch expected this year. For Aspaveli, we see growth driven by international launches and patient returns from oral treatments. A new device launch will ease administration and strengthen our competitive position.
Q: Could you expand on the operational improvements for Vonjo and measures to drive growth? Also, regarding Gamifant's indication expansion, should we expect a sales inflection in the second half of this year? A: For Vonjo, we've strengthened our medical area and improved outreach to key centers. We expect gradual growth for Gamifant, with the potential to double sales over time, but not immediately post-approval.
Q: How has the macro environment affected your business development approach? Have there been any changes in your regulatory activities with the FDA? A: The current environment presents both threats and opportunities, with more favorable conditions for buyers. We are actively exploring opportunities. We have not experienced any significant changes with the FDA, and our priority review for Gamifant is on track.
Q: Given Q1's impact on Vonjo from stocking effects, do you expect growth on a full-year basis? Is there a desire to add novel molecules to the pipeline? A: We are confident in Vonjo's growth this year despite past challenges. We are focused on adding new compounds to innovate our portfolio and move up the value chain.
Q: Can you help us understand the dynamics in Q1 for Vonjo, particularly regarding destocking and catastrophic impacts? A: Approximately 2/3 of the impact was due to stock, and 1/3 due to gross-to-net adjustments. We expect operational improvements to return Vonjo to a growth trajectory.
Q: Could you quantify the phasing benefit for Elocta in Q1 and discuss potential tariff impacts on Sobi? A: Elocta benefited from phasing, with a single-digit impact overall. Potential tariffs would be manageable, but we refrain from speculating on specifics.
