In today’s briefing:
- Mayne Pharma (MYX AU): High Risk/Reward as an FDA Letter Causes a Tailspin
- Jiangsu Hengrui (1276 HK) H-Share IPO: Index Inclusion Later This Year
- Mayne Pharma (MYX AU): Firm Support From Cosette Would Be Welcome About Now
- Mirxes Pre-IPO: Challenges for Mass Adoption Become Clearer
- Hinge Health (HNGE): VC Backed Virtual Therapist Company Seeking $2.6b Valuation
- SK Biopharmaceuticals (326030 KS): Starts 2025 on Slower Note; Xcopri US Sales Growth Moderates
- Omada Health (OMDA): Virtual Healthcare Provider for Chronic Conditions Filed for IPO
- Align Technology: Innovative Product Offerings
- BSEM: Growth Continues to Impress
- IMNN: First Site Activated for Phase 3 OVATION 3 Trial
Mayne Pharma (MYX AU): High Risk/Reward as an FDA Letter Causes a Tailspin
- Mayne Pharma (MYX AU) shares declined 15.76% after the public disclosure of an untitled FDA letter relating to NEXTSTELLIS promotional materials.
- Mayne opines that the letter is not price sensitive as it does not prevent ongoing NEXTSTELLIS sales. Its response will likely withdraw the problematic presentation and adopt a compliance program.
- The scheme is unlikely to be derailed, as I estimate that the MAC clause should not be triggered in the worst-case scenario of no NEXTSTELLIS sales. Risk/reward is attractive.
Jiangsu Hengrui (1276 HK) H-Share IPO: Index Inclusion Later This Year
- Jiangsu Hengrui Medicine (600276 CH) could raise up to US$1.6bn in its H-share listing if the Offer Size Adjustment Option and the Overallotment Option are both exercised.
- There is a big allocation to cornerstone investors that is locked up for 6 months. That eliminates the possibility of Fast Entry inclusion to global indexes.
- Jiangsu Hengrui (1276 HK) should be added to Southbound Stock Connect from the open of trading on 20 June following the end of the Price Stabilisation period.
Mayne Pharma (MYX AU): Firm Support From Cosette Would Be Welcome About Now
- They say bad things come in threes. First, Mayne Pharma (MYX AU)announced TherapeuticsMD (TXMD US)‘s legal lawsuit. Then shares buckled in the wake of Trump’s executive order on pharma.
- The final straw was the FDA accusing Mayne of giving misleading impression of the risks of its oral birth control pill. Shares are now a whopping 29% adrift of terms.
- Mayne reckons the lawsuit and the FDA letter are not materially price sensitive; and it intends to move forward with the Scheme. A similar intention from Cosette would be welcome.
Mirxes Pre-IPO: Challenges for Mass Adoption Become Clearer
- After an IPO attempt two years ago, Mirxes filed an updated prospectus in an attempt to raise at least US$100m via a Hong Kong listing.
- In our previous note, we analyzed its product pipelines and highlighted signs of commercialization challenges.
- In this note, we note that the company expanded its clinical trial plans. Yet, more data shows that blockbuster-level uptakes are unlikely given the profile of its clinical data.
Hinge Health (HNGE): VC Backed Virtual Therapist Company Seeking $2.6b Valuation
- The venture-capital backed company set terms for its IPO on Tuesday. The company will be offering 13.666 million shares at a $28-$32 range equating to a valuation of $2.3b-$2.6b.
- Their revenue was $123.8 million and $82.7 million for the three months ended March 31, 2025 and 2024, respectively, representing a year-over-year growth rate of 50%.
- This IPO is checking the boxes in terms of growth and the valuation comes at a significant discount to a previous funding round making the deal attractive for new investors.
SK Biopharmaceuticals (326030 KS): Starts 2025 on Slower Note; Xcopri US Sales Growth Moderates
- SK Biopharmaceuticals (326030 KS) announced muted 1Q25 result, with all key parameters, including revenue, operating profit, and net profit declining sequentially, as the Xcopri sales in the U.S. moderates.
- Xcopri U.S. sales increased 3% QoQ, which is the lowest over the last one year, due to seasonal inventory drawdown, restructuring of major pharmacy chain, and high base effect.
- SKBP considers Xcopri U.S. revenue moderation as ‘temporary’ and sees recovery in 2Q. However, high revenue exposure to the U.S. seems to be a serious headwind in current uncertain scenario.
Omada Health (OMDA): Virtual Healthcare Provider for Chronic Conditions Filed for IPO
- Omada delivers virtual care between doctor’s visits, providing an engaging, personalized, and integrated experience for their members that is designed to improve their health
- Revenue increased by 38% from $122.8 million to $169.8 million for the years ended December 31, 2023 and 2024, respectively.
- The company’s last funding round, Series E (February 2022), secured $192 million in a round led by Fidelity Management & Research with a valuation north of $1bn.
Align Technology: Innovative Product Offerings
- Align Technology, a key player in the dental technology sector, has shown a mixed performance in its first quarter results for 2025.
- The company, which operates in the segments of Clear Aligners and Systems and Services, reported revenues of $979.3 million, which is a slight decline both sequentially and year-over-year.
- Despite these decreases, there are notable positive highlights: Clear Aligner volumes increased across several regions, with particularly strong growth observed in Asia-Pacific (APAC) and Europe, Middle East, and Africa (EMEA).
BSEM: Growth Continues to Impress
- BioStem Technologies is a leading innovator focused on harnessing the natural properties of perinatal tissue in the development, manufacture, and commercialization of allografts for regenerative therapies.
- The company announced its 1Q2025 preliminary financial results.
- The company continues to execute at a high level by posting record 1Q revenue and continued growth in earnings.
IMNN: First Site Activated for Phase 3 OVATION 3 Trial
- On May 12, 2025, Imunon, Inc. (IMNN) announced financial results for the first quarter of 2025 and provided a business update.
- The company recently announced that the first clinical trial site for the Phase 3 OVATION 3 trial of IMNN-001 in patients with advanced ovarian cancer is activated and a second site will be activated this week.
- Imunon previously reported results from the Phase 2 OVATION 2 trial that showed IMNN-001 plus neoadjuvant and adjuvant chemotherapy (NACT) increased median overall survival (OS) to 46 months vs. 33 months for standard-of-care NACT.
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