BB Biotech AG

In April BB Biotech´s share price declined by 9.2% in CHF and the Net Asset Value declined by 6.6% in USD. The Nasdaq Biotech Index was down by 6.0% in April.   
 
BB Biotech reported its first quarter result on April 26 with a net profit of CHF 260 mn, compared to a net loss of CHF 254 mn in the same period of 2023. In the first quarter, portfolio adjustments primarily involved capitalizing on gains from larger, established long-term holdings. Profit-taking activities targeted mid-to-larger entities such as Vertex, Argenx, Ionis, Intra-Cellular, Moderna, and Neurocrine, alongside minor tactical sales, generating a substantial cash influx of USD 166 mn. The quarter's capital expenditures included CHF 110 mn for dividend payouts and USD 70 mn for bolstering existing smaller positions and establishing a new stake in Annexon. Annexon, a clinical-stage company focuses on developing therapeutic candidates aimed at the complement system to tackle severe autoimmune disorders. BB Biotech engaged in capital increases for Celldex and Esperion. Further portfolio enhancements involved additions to Sage and Generation Bio, and profits from Crispr Therapeutics were reallocated to Beam Therapeutics.
 
Please find below selected highlights from a few of BB Biotech´s portfolio companies:
 
Intra-Cellular Therapies (+3.8%, in USD) announced on April 16 positive topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Topline results from their second Phase III study, Study 502, are anticipated late in the second quarter of this year. Lumateperone 42 mg given once daily as adjunctive therapy to antidepressants met the primary endpoint and secondary endpoints. Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in both the primary and the key secondary endpoints.
 
Ionis Pharmaceuticals (-4.8%, in USD) announced on April 7 full results from the Phase III Balance study of Ionis' lead independent investigational medicine, olezarsen, for the treatment of adults with familial chylomicronemia syndrome (FCS). The olezarsen 80 mg monthly dose met the primary endpoint. Importantly, olezarsen reduced the incidence of acute pancreatitis (AP) events over the 12-month treatment period compared to placebo. Olezarsen also demonstrated a favorable safety and tolerability profile. Based on these data, Ionis is pursuing regulatory approval of olezarsen as a potential breakthrough treatment for adults with FCS.
 
Sage Therapeutics (-25.6%, in USD) announced April 17 topline results from PRECEDENT, a double-blind, placebo-controlled Phase II study of the investigational oral medicine dalzanemdor (SAGE-718) in people with mild cognitive impairment (MCI) in Parkinson’s Disease (PD). The PRECEDENT study did not meet its primary endpoint of demonstrating statistically significant difference from baseline in participants treated with once-daily dalzanemdor versus placebo. Dalzanemdor (SAGE-718) was generally well-tolerated, and there were no new safety signals observed.

Despite the challenging macro environment, the companies in BB Biotech’s portfolio are very sound and they continue to make good progress. Significant news flow is expected over the course of the year: Alnylam will announce Phase III HELIOS-B results for vutrisiran in TTR cardiomyopathy patients. Agios is expected to release ENERGIZE-T results for Pyrukynd in transfusion-dependent alpha- and beta-thalassemia patients. Macrogenics will give an update on its Phase II TAMARACK trial of vobra duo in metastatic castration-resistant prostate cancer patients. Revolution Medicines is expected to publish data on RMC-6236, a multi KRAS inhibitor. Moderna’s RSV vaccine mRNA-1345 should be granted approval during the second quarter of 2024, in time for the start of the fall vaccination season.