Daily Brief Health Care: Tokyo Stock Exchange Tokyo Price Index Topix, Hanmi Pharm, Malo Medical Management, Hologic Inc, Basilea Pharmaceutica Ag, OSE Immuno, Regeneron Pharmaceuticals, Cue Health and more

• Overseas investors feel that the disclosure of English documents by Japanese companies is slow-paced and the majority of overseas investors are not satisfied with the English disclosure.
• Without sufficient disclosures in English, it is impossible to conduct a detailed analysis of the portfolio company. This also casts a shadow over engagement.
• Given the narrowing coverage of sell-side analysts, companies should proactively disclose English-language materials at the earliest possible time. For long-term investors, English-language disclosures such as annual securities reports are also useful.

• With 1H23 revenue of KRW704 billion, Hanmi Pharm (128940 KS) is on track on surpass its 2022 revenue of KRW1.33 trillion to reach a new high in 2023.
• Hanmi is developing epeglenatide as personalized obesity drug for South Korean market. With the spectacular success of obesity drugs in the U.S., epeglenatide seems to be have great market potential.
• Outlicensing partner Merck is conducting phase 2b trial on efinopegdutide for NASH, with result expected in 2025. Efinopegdutide obtained fast track designation from FDA, which should accelerate its commercialization.

• Malo’s revenue had good growth, but revenue scale is still small. At the current gross margin level, it would be difficult to generate decent profits considering the large SG&A expenses.
• Dental care expansion is difficult. Malo would face the challenging such as lack of high-quality dentists and centralized procurement. Both would drag down profits and cash flow.
• We are not optimistic about Malo’s share price performance after IPO. This industry’s profit mode is not mature. Most of chain dental services providers are still in cash-burning expansion stage.

• Hologic, Inc. exceeded analyst expectations in terms of revenue as well as earnings.
• Non-GAAP earnings per share were $0.93 and the total revenue was $984 million.
• In Mammography, Hologic delivered more gantries in Q3 than in Q1 and significantly fewer than in Q2.

Basilea has announced that the US FDA has accepted its New Drug Application (NDA) for ceftobiprole. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 3 April 2024, meaning that Basilea will have a regulatory decision for its lead antibiotic asset in the US in early-Q224, consistent with prior guidance. Supported by three separate Phase III clinical trials, the company is seeking approval for three indications: Staphylococcus aureus bacteraemia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). With the bacterial infection market in the US representing a sizeable opportunity, we believe the decision from the FDA could represent a significant catalyst for Basilea.

OSE Immunotherapeutics (OSE) has announced its H123 results, providing an operational and a financial update. Highlights from the period included positive recommendations for a confirmatory pivotal Phase III trial for lead asset Tedopi in non-small cell lung cancer (NSCLC), which is on track to commence in 2024. OSE also claimed full rights to its most advanced immuno-inflammation asset, Lusvertikimab (previously being developed in partnership with Servier). Post period, the company reported a positive safety review for Lusvertikimab from the ongoing Phase II trial in ulcerative colitis (UC). Patient enrolment is expected to be completed in Q423, with top-line results in the next few months. OSE also recently announced a €200,000 grant from the French government and Region Pays de la Loire to weave RNA therapeutics into its preclinical R&D engine, representing a new opportunity for the company. At end-June 2023, OSE had a pro-forma gross cash position of €33.6m, which we estimate will provide a runway through to Q424 (H123 cash burn of €11.7m). We value OSE at €311.3m or €14.4 per share, with Tedopi as the primary contributor to this valuation.

• Regeneron delivered an all-around beat in the previous quarter, demonstrating progress toward their long-term objective of business growth and revenue diversification.
• Total revenues saw an 11% increase compared to the previous year’s quarter, primarily driven by collaboration revenues with Sanofi and net product sales of Libtayo, which exhibited impressive growth of 39% and 49%, respectively.
• Notably, non-EYLEA revenue contributions accounted for 41% of total revenues, marking a significant proportion, the highest in the last decade, excluding contributions from COVID-19 antibodies.

• This is a special one-time report on Cue Health, a company once lauded for its promise in the diagnostics sector.
• Amidst diminishing fortunes, the company is under the scrutiny of significant shareholder, Tarsadia Investments.
• This report aims to dissect the various valuation scenarios underpinning Cue Health, providing a lucid understanding of its investment potential amidst the unfolding drama.