Merck KGaA Q1 2022 earnings call: BAVENCIO global sales increased by 107.3% in Q1 2022 (YoY) and MAVENCLAD global sales increased by 28.7% in Q1 2022 (YoY)

Immuno-oncology

Financial
BAVENCIO global sales increased by 107.3% to $134M in Q1 2022 (as compared to $65M Q1 2021). BAVENCIO global sales increased by 5.5% in QoQ terms (as compared to $127M Q4 2021), particularly in EU and Japan
~5% QoQ growth driven by 1L mUC launch ramp-up in Europe, supported by the U.S. and Japan

Commercial
Further reimbursements in major EU markets achieved in Q1 (Italy in April and Spain in May)

Clinical
Company expects initiation of combination of Avelumab with novel therapies in urothelial cancer reinforcing its presence in Maintenance settings in Q2 2022
Mentioned ongoing, recent Phase 2 study (NCT05327530) which includes BAVENCIO combination with M6223 (in-house developed anti-TIGIT antibody) in maintenance setting for  2L urothelial carcinoma
No mention of BAVENCIO monotherapy in 1L NSCLC JAVELIN Lung 100 trial update during the call

Neurology

Financial
MAVENCLAD global sales increased by 28.7% to $199M in Q1 2022 (as compared to $154M in Q1 2021)
However, sales were flat  (-1.1% in QoQ terms as compared to $201M in Q4 2021)  driven by low number of “Y2 patients” from Q1 2021
New patients using MAVENCLAD is ~15% globally vs. Q4 2021

Clinical/Regulatory
Regarding evobrutinib, the company stated that due to the situation in Ukraine/Russia, it is looking for patients outside the affected countries to ensure the integrity of the studies
It mentioned that mitigation plans are ongoing that includes moving the study participants to other areas and enrolling more patients from countries
It plans to make “amendments” to the study protocols to make it more “event driven” in order to mitigate participants in such situations
It has mentioned that there are currently no changes to the timelines (trials data expected in Q4 2023), however the exact dates will depend on the situation in Ukraine/Russia

Implications for Amgen:

ABP206 & ABP234:

BAVENCIO is more focused on UC indication. BAVENCIO is unlikely to have a major impact on KEYTRUDA/OPDIVO’s already marketed indications in the IO space

ABP692:

MAVENCLAD was a late entrant to the oral MS space due to safety concerns. While its a high efficacy product, it mostly competes with other older orals such as dimethyl fumarate, siponimod, ponesimod and fingolimod and does not pose any challenge to OCREVUS.
Its evobrutinib, which is a BTK inhibitor, is ahead in terms of clinical development for the treatment of RMS. A potential approval for this is expected in Q1 2025. With its oral dosing and blood-brain barrier penetration, BTK inhibitors are expected to have a medium-high impact on OCREVUS and its biosimilars

Table 1: Merck KGaA’s main product revenues  

*as mentioned in the report
Separate sales figures for US and International regions not provided

Source: Q1 2022 Presentation, Press release, Summary