Daily Briefs

• Back on the 21st Feb 2025, Mayne Pharma (MYX AU), a leader in dermatology and women’s health, entered into a Scheme with US-based pharmaceutical outfit, Cosette Pharmaceuticals, at A$7.40/share. 
• The transaction is progressing – the HSR Act condition was satisfied last week. A Scheme Booklet should be issued shortly, with an expected vote mid-June and late-June/early-July implementation. 
• Shares declined 3.1% yesterday over concerns a MAC could be triggered on the back of the Trump’s executive order on pharma. The impact is likely mixed, but leans neutral.

• On Monday, President Trump signed an executive order requiring drugmakers to start offering US patients the lowest price for a drug in a peer country (the Most Favoured Nation price).
• Mayne Pharma (MYX AU) is exposed as US accounts for 84% of revenue. I estimate that the average price reduction should be <16% so that the MAC is not triggered.  
• However, the MAC is not triggered if it arises “from any change in any law, regulation or rule of a Government Agency”, which should capture the Trump order.

• Innogen, a China-based near-commercial stage biotech company, is looking to raise at least USD 100 million via a Hong Kong listing. CITIC Securities and CICC are the joint sponsors.
• In this note, we look at the company’s product pipeline, its pre-IPO investors, and management.
• Our initial view is that the stock will rely heavily on its sales ramp. Yet we are not seeing signs that the company is at full throttle post-NMPA approval.

• Takeda Pharmaceutical (4502 JP) announced FY25 result, with revenue and operating profit being in-line with guidance. Revenue grew 7.5% YoY, driven by continued strong momentum from Growth and Launch Products.
• Takeda guided for its FY26 outlook of lower sales and higher margins, reflecting near term headwinds amid cost control.
• Continued strong performance of its Growth and Launch product portfolio, ripe late-stage pipeline, and expected margin improvement from FY26 envisage long-term growth prospect of the company. 

• Sales increased by 1.3% YoY to JPY405mn, with operating loss widening to JPY756mn due to higher SG&A expenses.
• In the Specified Cell Products Manufacturing Business, sales were JPY300mn, supported by stable orders and new manufacturing.
• Regenerative medicine segment loss narrowed to JPY217mn due to reduced R&D expenses after discontinuing α-GalCer/DC development.

Newron has announced receipt of regulatory clearance to conduct its Phase III programme for evenamide (ENIGMA-TRS), taking it one step closer to the market. It will comprise two separate trials: ENIGMA-TRS 1, a 600-patient international study with enrolment set to start imminently; and ENIGMA-TRS 2, a 400-patient US-focused study with enrolment due to commence within the next three months. Note that the decision to conduct two separate Phase III trials (instead of a widely anticipated single study) was slightly surprising, although we believe this may be strategic with a view to maximise success potential and gain regulatory approval, particularly in the key US market. The 12-week results from the ENIGMA-TRS 1 study, for which we believe the company is well capitalised, are anticipated in Q426, a major upcoming inflection point for Newron. We will present updated estimates in due course based on this latest news.

• Sales increased 9.9% YoY to JPY644.6bn, driven by strong overseas sales of dialyzer and dialysis-related products.
• Operating profit rose 19.1% YoY to JPY26.6bn, despite increased unrealized profit deductions and higher provision for doubtful accounts.
• Recurring profit decreased 44.6% YoY to JPY10.8bn, impacted by JPY5.4bn forex losses and increased equity in losses of affiliates.

• Protalix is a clinical and commercial pharmaceutical company using its proprietary ProCellEx plant-based expression system to pro duce thera peutic proteins for global markets.
• The company has two commer cialized products, Elelyso that is marketed by Fiocruz in Brazil & Pfizer in the rest of the world for Gaucher Disease and Elfabrio which was approved in May 2023.
• Chiesi Rare Disease will commercialize Elfabrio globally.

• Radiopharm Theranostics is advancing a portfolio of imaging and therapeutic radiopharmaceutical candidates in oncology.
• Its approach recognizes the opportunities in tumors beyond prostate, thyroid & neuroendocrine targets originated by precision oncology & validated by clinical trials & regulatory approval.
• RAD101, an 18F radioisotope imaging brain metastases is the most advanced asset.

Q125 marked another active period for SIGA’s order book, with BARDA exercising the final $26m intravenous (IV) TPOXX option in March, expected to be delivered in 2026, consistent with our estimates. Product revenues were $5.8m, driven by international TPOXX deliveries, which we believe may be related to the outstanding $6.7m contract with the Canada Department of National Defence (CDND). Importantly, sales momentum continued into Q2, with $62m in oral and IV TPOXX deliveries in April, substantially servicing the $94m order book at end-Q125. Liquidity remains strong, with net cash of $162.3m at end-Q125 enabling a $0.6/share dividend announcement in April (an attractive payout ratio of 72% and yield of 10.6%). We make modest revisions to our estimates, with our valuation upgrading slightly to $14.78/share with the model roll-forward ($14.41/share previously).