Release Date: July 25, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- UCB SA (UCBJF, Financial) reported a significant turnaround in net sales, achieving a growth of 11% or 13% at constant exchange rates, compared to a decline of 12% or 14% the previous year.
- The company successfully launched several key products, including ZILBRYSQ in the US and RYSTIGGO outside the US, contributing to the positive sales performance.
- UCB SA (UCBJF) achieved five new approvals in various regions, including BIMZELX for hidradenitis suppurativa in Europe and ankylosing spondylarthritis in China.
- The company has a strong pipeline with 10 new patient populations in 10 projects expected to deliver significant news flow in the second half of 2024.
- UCB SA (UCBJF) improved its ESG rating by increasing product availability in low and medium-income countries and enhancing access to its products, reaching 82% in June.
Negative Points
- Despite the positive sales growth, UCB SA (UCBJF) reported a decline in adjusted EBITDA to 23%, attributed to substantial investments behind new product launches.
- Operating expenses increased by 23%, driven by higher marketing and sales expenses, R&D investments, and one-off costs related to the implementation of a new growth organization model.
- The company experienced a decrease in other operating income, primarily due to the absence of a one-time sale of a portfolio of established brands that occurred in the previous year.
- The launch of new products like BIMZELX in the US faced delays, impacting the initial uptake and requiring significant investment in patient services and access programs.
- Recruitment challenges were noted in the Staccato alprazolam trial, which aims to address a complex and technically challenging unmet need in epilepsy, potentially delaying the study's progress.
Q & A Highlights
Q: Regarding the phase versus scrip ratio for BIMZELX, what is your assumption for refractory versus frontline patients?
A: Currently, about 20-25% of patients are bionaive, with the rest having failed on various medications. This mix is expected to remain relatively stable, with a slight increase in bionaive patients and more government patients joining the paid segment. (Emmanuel Caeymaex, Chief Commercial Officer)
Q: Can you provide insights into BIMZELX's European performance, particularly the split between psoriasis and other indications?
A: Approximately 85% of patients worldwide are psoriasis patients, but this ratio is changing as psoriatic arthritis and axSpA get reimbursed. The uptake in hidradenitis suppurativa is promising, with a couple of hundred patients in Germany within three months of launch. (Emmanuel Caeymaex, Chief Commercial Officer)
Q: What is the timing and confidence around upgrading BIMZELX to first-line use in the US?
A: Expanding preferred status for BIMZELX with payers could take one to two years. Many payers want to see the full range of indications approved first. We expect a stepwise expansion to earlier lines over the next one to two years. (Emmanuel Caeymaex, Chief Commercial Officer)
Q: Can you provide updated views on dapirolizumab in lupus?
A: We are eagerly awaiting the results of our first Phase 3 study. The mechanism of action is promising, and we have taken care to define a homogeneous patient population. We consider a 20% improvement over placebo as clinically meaningful. (Iris Loew-Friedrich, Chief Medical Officer)
Q: Can you discuss the BIMZELX launch preparations in hidradenitis suppurativa and any read-through from the Cosentyx launch?
A: HS is a complex disease requiring significant education and awareness efforts. The Cosentyx launch shows that improved therapies encourage more physicians to treat HS. We are optimistic about BIMZELX's positioning as a highly efficacious agent. (Emmanuel Caeymaex, Chief Commercial Officer)
Q: What might be driving the conservatism in your 2024 total revenue guidance?
A: We are confident in reaching the top end of our guidance. Despite a less favorable comparison basis in the second half, we expect to grow H2 at least at the same rate as H1. (Sandrine Dufour, Chief Financial Officer)
Q: Could you share more insights into the outcomes of the RYSTIGGO trial on autoimmune encephalitis?
A: We have terminated the development program due to insufficient efficacy. We are analyzing additional biomarkers to understand the disease better. Rozanolixizumab performed as expected in terms of IgG level reduction and safety. (Iris Loew-Friedrich, Chief Medical Officer)
Q: What are your thoughts on the competitive landscape in gMG and your confidence in RYSTIGGO?
A: We are confident in RYSTIGGO's unique data, particularly its impact on fatigue dimensions, which is highly relevant for patients and physicians. (Iris Loew-Friedrich, Chief Medical Officer)
Q: Can you provide an update on the MOG-AD Phase 3 trial and recruitment targets?
A: Recruitment is challenging due to the rarity of the disease and the need for referral networks. We are confident in bringing the study to a good conclusion but require more time for recruitment. (Iris Loew-Friedrich, Chief Medical Officer)
Q: What are the challenges in recruiting for the Staccato alprazolam trial, and how are you addressing them?
A: The trial is technically challenging, requiring patients and caregivers to manage complex procedures during seizures. We need more time to ensure an adequate sample size of evaluable patients. (Iris Loew-Friedrich, Chief Medical Officer)
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
