Smartkarma Daily Briefs

• Mayne Pharma (MYX AU) disclosed that Cosette asserts that a material adverse change has occurred due to its trading performance, litigation and FDA untitled letter. 
• Cosette has not quantified the impact, and Mayne disputes the assertion. Mayne’s trading performance is likely the largest contributor to Cosette’s MAC-related claims. 
• Precedent schemes suggest a lower offer is the best-case scenario. An unwilling bidder looking for angles, contractually, to exit suggests the likely outcome is a scheme termination.

• The review period ended on 30 April, the changes should be announced on 30 May and will be effective after the close of trading on 13 June.
• There could be 5 changes in June where passive trackers will need to trade between 0.7-2x ADV in the forecast adds and sell between 1-4x ADV in the forecast deletes.
• A long adds/ short deletes trade has gone nowhere in the last 6-7 months, and the volatility of the trade has reduced even further in the last couple of months.

• Strong results reflect progress of existing approved drugs including key oncology drugs.
• Mazdutide is set to be released in 2025, and the company is currently making plans for the release.
• Innovent Biologics continues to add to its drug development portfolio.

• CytoSorbents is commercializing its E.U. approved CytoSorb blood purification technology to treat life-threatening conditions in the intensive care unit and cardiac surgery.
• The company also seeks U.S. and Canadian approval of a second product, DrugSorb-ATR, to reduce perioperative bleeding risk in patients on blood thinners during cardiac surgery.
• Based on the results of its pivotal U.S. and Canadian STAR-T trial, the company submitted for FDA De Novo approval on September 27, 2024, and Health Canada on November 1, 2024, with final regulatory decisions expected in 2025.

• Hugel Inc (145020 KS) reported strong 1Q25 result, with all key parameters recording double-digit growth. The robust growth was driven by balanced gains across all product portfolios.
• In March, Hugel has fully commercialized Letybo in the U.S. through the partnership with Benev. The company aims to capture 10% market share in the U.S. within three years.
• Earlier this month, Hugel has officially launched Botulax in UAE. This marked the second official launch in the Middle East, following the product’s debut in Kuwait.

• Krsnaa Diagnostics (KRSNAA IN) reported robust margin expansion in FY25 driven by operational efficiency and a favourable business mix. Retail footprint expanded significantly, quadrupling touchpoints in focus states.
• Enhanced profitability highlights the effectiveness of cost control and operational leverage. Retail growth diversifies revenue beyond the core PPP model.
• Reinforces management’s commitment to profitable and disciplined growth over aggressive top-line targets alone. Acknowledges execution hurdles like site delays but underscores confidence in receivables and future growth.

• The investment logic of vaccine companies is different from that of biotech. Generally speaking, vaccine companies cannot develop to large scale without successfully betting on blockbuster vaccine varieties.
• Commercialization of Ab&B’s vaccines could face uncertainties due to fierce competition/price war/slower R&D progress. Some Class II vaccines could be converted to Class I vaccines. Breakthrough point lies in internationalization. 
• After Series B financing, post-money valuation reached RMB4.2 billion. Since CanSino’s pipelines are either global innovative, or potential best-in-class or first-in-class in China, Ab&B’s valuation should be lower than CanSino.

• Product revenue growth modest, as Rebis Health (Rebis) contribution not yet material.
• Vivos reported 1Q25 product revenue of $1.8 million, up 8% Y/Y, with 3,736 oral appliance arches sold, an 87% increase over the 1,996 sold in 1Q24.
• The higher volume growth was mostly driven by the lower priced guide sales. 

• Azitra is developing genetically engineered bacteria for therapeutic use in dermatology.
• The company possesses a microbial library of 1,500 unique bacterial strains that are candidates for a variety of indications.
• Azitra’s lead candidate is ATR-12 for the rare disease Netherton syndrome (NS).

Basilea Pharmaceutica has announced the launch of Zevtera, its lead anti-bacterial treatment, in the US by partner Innoviva Specialty Therapeutics (IST), marking a key strategic milestone for the company. Zevtera, an advanced generation IV cephalosporin antibiotic, was approved by the FDA in April 2024 for three separate indications, including the highly aggressive Staphylococcus aureus bloodstream (SAB) infection. IST was signed as the US licensing partner in December on attractive deal terms, including an upfront payment of US$4m, up to US$223m in sales-related milestone payments as well as tiered royalties (high-teens to mid-20s percent of sales). The US is the most important market for Zevtera, accounting for c 85% of the drug’s commercial opportunity, and we expect this launch to boost top-line performance over the coming years. Zevtera holds 10-year market exclusivity in the US and we project peak sales potential of c US$300m in SAB infections in the US.