Health Care Archives | Page 87 of 137 | Smartkarma

• In this insight, we take a look at some of the names with high likelihood of being involved in index changes for the Hang Seng Index in September 2023.
• The index changes for the September 2023 rebalance could be announced in mid-August and implemented in early-September.
• Although the index methodology is highly subjective and predicting index changes is extremely tricky, the HSI is an important index in the region and here are our thoughts for September. 

• Genmab A/S (GMAB US) recorded 30% YoY growth in royalty revenue on net sales of Darzalex to DKK1,952 million, representing 68% of total revenue in 1Q23.
• Genmab has guided for 2023 Darzalex royalty revenue of DKK10.4–11.1B, compared to royalty revenue of DKK10.1B in 2022, based on estimated Darzalex 2023 net sales of $9.4 – 10.0B.
• In May 2023, Genmab received FDA approval for Epkinly as the first and only T-cell engaging bispecific antibody for the treatment of relapsed or refractory diffuse large B-cell lymphoma.

• The bottom line from the INM-755 Phase II study’s top-line results.

• InMed published top-line data for its most advanced drug development program, INM-755, a cannabinol (CBN)-based topical skin cream to treat symptoms associated with a rare genetic dermatological condition called epidermolysis bullosa (EB).

• Using a wide lens approach, the Phase II study produced sufficient clinically important chronic itch relief data to support a pathway to further development and potentially bigger commercial opportunities.

Paradigm has announced the completion of patient recruitment for stage one (dose selection) of its pivotal Phase III trial, PARA_OA_002, a multi-centre (US/Australia/UK/EU/Canada), two-stage, adaptive, randomised, double-blind, placebo-controlled study to assess injectable pentosan polysulfate (iPPS) in patients with knee osteoarthritis (kOA) pain. Paradigm has efficiently recruited participants for the trial through various initiatives, such as through its partnership with NFL Alumni Health. Management expects stage one to be complete in Q3 CY23, and for stage two to commence with the most effective dose later in H2 CY23. The selected dose will also be used in the initiation of the separate confirmatory Phase III trial in H2 CY23. These events represent key milestones for Paradigm, in our view.

Oryzon has announced positive aggregate safety data for vafidemstat, which is being evaluated in the ongoing PORTICO trial as a potential treatment for borderline personality disorder (BPD). The independent data monitoring committee (DMC) has reviewed the safety data from the first 167 patients treated in the trial and reported no cases of treatment-related serious adverse events (AEs) or deaths. The DMC has therefore recommended that PORTCIO proceeds without modification until patient enrolment is completed (expected n=188), which is anticipated to be in Q323. We view this as an encouraging update for the clinical development of vafidemstat and believe that the announcement of top-line data, expected in Q124, may represent the next most significant catalyst for the PORTICO trial and for Oryzon’s central nervous system (CNS) portfolio.

OSE Immunotherapeutics has announced that Tedopi, the company’s lead cancer vaccine candidate, has been granted a new patent by the United States Patent and Trademark Office. The patent provides further protection of Tedopi as a potential second-line treatment in non-small cell lung cancer (NSCLC) patients post PD-1/PD-L1 immune checkpoint inhibitor (ICI) failure. We note that Tedopi is already being developed for HLA-A2+ patients with advanced or metastatic NSCLC. OSE is preparing for a follow-on Phase III confirmatory and potentially pivotal trial by end-FY23 or early FY24, and the additional patent protection represents a key milestone in the clinical development of Tedopi, in our view. Additionally, we note that the company already has similar patent approval in Japan, with multiple patent applications pending in other international markets.

Ahead of its H123 results and an anticipated period of increased business activity in the second half of the year, we present a preview of SIGA Technologies, which continues to have strong fundamentals (despite the bearish macro environment) with several potential inflection points on the horizon. The nearest catalysts, in our opinion, are the upcoming TPOXX deliveries to the US strategic national stockpile (which we expect in Q3/Q423) and data readouts from the post-exposure prophylactic (PEP) label expansion trials, anticipated in Q323, positive results from which could materially expand SIGA’s addressable market. With a strong balance sheet and potential incremental income generation for shareholders (via dividends and buybacks), we believe that SIGA has a resilient business case in the biotech space.

• Celltrion Inc (068270 KS) has launched Humira biosimilar Yuflyma in the U.S. market, with a list price of $6,576.50 per month, 5% cheaper than Humira.
• Yuflyma is a citrate-free formulation that is highly concentrated. More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation.
• Celltrion has submitted marketing application to the FDA for Eylea biosimilar candidate, CT-P42. The company plans to file for approval for the same in Europe and other countries later.

• COVID-19 didn’t bring Wondfo explosive performance growth because China’s official COVID-19 detection method is nucleic acid test while Wondfo’s strength is antigen detection,which is used in later stage of COVID-19.
• Revenue growth would slow down in 2023 due to the high base last year.2023 is a good time to bottom fish this stock as Wondfo’s performance growth would recover afterwards.
• After continuous corrections, the current valuation is already at a low level, and has already priced in the negative impact of the decline in COVID-19 business and IVD centralized procurement.

• Hologic managed to exceed the revenue expectations as well as the earnings expectations of Wall Street.
• The company’s financial results surpassed expectations, driven by robust organic revenue growth in key divisions like Diagnostics, Surgical, and Breast Health excluding COVID-19, driven by new products, market expansion and customer loyalty.
• Hologic’s COVID-19 assay revenue was $233 million, down 47% sequentially, reflecting lower testing demand and increased competition.

• Country Garden Services Holdings (6098 HK) and Zhongsheng Group (881 HK) are high probability deletions in September, while Trip.com (9961 HK) is a high probability inclusion.
• The second add could be BeiGene Ltd (6160 HK) if it passes the velocity test. If not, Chow Tai Fook Jewellery (1929 HK) will be added.
• With the exception of Zhongsheng Group (881 HK), short interest has been rising on all the other stocks and could affect how the stocks trade close to implementation date.

• For the month of June, 13 new deals (firm and non-binding) were discussed on Smartkarma with an overall announced deal size of ~US$9bn.
• The average premium for the new deals announced (or first discussed) in June was 42%.
• This compares to the average premium for all deals in 2022 (106 deals), 2021 (165 deals), 2020 (158 deals), and 2019 (145 deals) of 41%, 33%, 31%, and 31% respectively.

• Healthway Medical Corp (HMED SP) received a delisting proposal from OUE Lippo Healthcare (IHC SP) at S$0.048 per share, a 45.5% premium to the undisturbed price (28 June).
• The key conditions are HMED shareholder approval and the offeror and concert parties representing >50% of voting rights (satisfied due to irrevocables).
• The offer price is attractive. The EGM is likely to be held in late September. The current price of S$0.046 implies a gross spread of 4.3%.

• Takara Bio Inc (4974 JP) is anticipating 32% YoY decline in revenue to ¥53B in FY24. Both operating and net profits are expected to decline more than 60% YoY in FY24.
• The company has formulated the medium-term management plan 2026 for the three-year period ending in FY26, with the final-year quantitative targets being operating profit of ¥15 billion and ROE 8%.
• Considering Takara Bio’s FY24 operating profit guidance of ¥8B, FY26 target seems to be aggressive and difficult to achieve.

• YZY is a company that is serious about drug development However, there is actually high R&D risk of its pipeline candidates. So, YZY’s R&D capability has yet to be proven.
• There are still many unanswered questions in the whole direction of bispecific antibody. If YZY’s candidates fail to prove better marginal clinical benefits, they won’t have good commercialization performance. 
• YZY has a long way to go based on its pipeline situation. Considering Wuhan YZY Biopharma (YZY HK) has no product in commercialization stage, its valuation may not be high.

• The latest update will feature the addition of 25 single stock futures, as well as five single stock options from KOSPI. Eight single stock futures will be removed.
• The selection will now take place twice a year, in March and September. Also, the selection requirement includes being included in the KOSPI 200 and KOSDAQ Global.
• The shortened selection cycle and the significant potential for the change range to vary based on index review results can indeed have a notable impact.

• Two thirds of the way through the review period, we see 14 potential index changes at the December rebalance that will be implemented at the close on 8 December.
• We estimate a one-way turnover of 1.98% at the December rebalance leading to a one-way trade of CNY 5.32bn.
• The potential adds have outperformed the potential deletes and the Shanghai Shenzhen CSI 300 Index (SHSZ300 INDEX) over the last five months, though there is some near-term underperformance.

• The latest data of GC012F/GC007g at ASCO/EHA drove up share price, but the current clinical data do not necessarily guarantee the final druggability. So, we advise investors to be rational.
• Gracell’s pipeline may not solve the real pain points of CAR-T therapy. Until the global momentum of cell therapy is reversed, there’s no need to expect too much from Gracell.
• Gracell’s stock price would continue to fluctuate with positive clinical data or progress. However, the liquidity of this stock isn’t good. In this situation, both ups and downs are meaningless. 

• Sanofi (SAN FP) earns more than 20% revenue from its key growth driver, Dupixent. With expanding indications, Dupixent is on track to record €10B revenue in 2023.
• The company has added two new drugs in its portfolio this year. Since the beginning of 2023, Sanofi has reported five positive readouts for its pipeline.
• Sanofi aims to reach €10B vaccine sales by 2030 from €7B in 2022, fueled by accelerated pace of innovation. The company plans to launch RSV vaccine for infants this winter.

• We discuss the end of the mandatory lock-up periods for 41 stocks in Korea in July 2023, among which 6 are in KOSPI and 35 are in KOSDAQ.
• These 41 stocks on average could be subject to further selling pressures in June and could underperform relative to the market. 
• Among these 41 stocks, the top five market cap stocks include Lunit, Sungeel Hitech, KG Mobility, Enchem, and E&D Co. 

• Lotus Pharmaceutical (1795 TT)’s majority shareholder, Alvogen Emerging Markets Holdings (AEMH), aims to raise up to US$247m through an affiliated secondary block offering.
• The deal is a small one to digest at only 2.4 days of three month ADV, despite being about 8.7% of current mcap. 
• In this note, we will talk about the placement and run the deal through our ECM framework.

• Sosei Group (4565 JP) shares sold off heavily after a major setback in partner’s clinical trial. On June 26, Pfizer Inc (PFE US) decided to discontinue the development of lotiglipron (PF-07081532).
• PF-07081532 is one of three clinical candidates nominated by Pfizer during its multi-target drug discovery collaboration with Sosei to research and develop potential new medicines.
• As lotiglipron was the most advanced clinical candidate using Sosei’s drug discovery platform, the heavy sell-off seen in Sosei shares should not be considered as overreaction.

• Medikaloka Hermina (HEAL IJ) saw a strong recovery in patient volumes in 1Q2023, with margins starting to normalise from COVID highs and occupancy rates picking up. 
• The company is back on an expansion track and recently secured the first hospital in the new capital next year with two new hospitals planned to open this year.
• Medikaloka Hermina continues to focus on women & children and JKN patients but is also expanding into more intensive specialist treatments to drive profits. Valuations remain attractive versus peers.

• In FY23, Daiichi Sankyo (4568 JP) recorded Enhertu product revenue growth of 218% YoY to ¥208B, 4% ahead of forecast, driven by indication expansion and strong market penetration in US.
• For FY24, Enhertu product revenue is expected to increase 54% YoY to ¥320B, driven by higher utilization in HER2 positive and HER2 low breast cancer in US.
• Daiichi Sankyo has two more drug candidates in late-stage trials for various cancers. Contribution of oncology to total revenue is expected to increase to 45% in FY26 from 20% now.

• C&CE 1Q23A $2.1m, burn 1Q $1.6m, S-1MEF filed for raise
• YE22A Opex $34.2m vs. $14.1 y/y, Δ is redemptions/merger costs
• Warrants booked as liabilities (SEC de-SPAC ruling Apr 12, 2021)

• Kelun-Biotech is a China-based integrated innovative biopharmaceutical company. The company launched a deal to  raise up to US$200m via a Hong Kong listing.
• In our previous note, we looked at the company’s product lines and provided a brief overview on the company’s valuation.
• In this note, we provide an update for the book building. We provide our quick thoughts on the valuation and deal dynamics.

• MariMed is a multi-state operator (MSO) in the US cannabis industry.
• It has a national footprint spanning six states: Illinois, Massachusetts, Maryland, Delaware, Ohio, and Missouri.
• MariMed focuses on limited-license markets and strives to be vertically integrated wherever possible. 

• Invest Chosun recently reported that the three Celltrion Group companies including Celltrion Inc, Celltrion Healthcare, and Celltrion Pharm are close to announcing a merger in July.
• Although Celltrion was not included this time as suppliers of Humira biosimilar products by OptumRX, there is still a potential for Cigna Express Scripts to include Celltrion’s product this year.
• We think Celltrion Inc and Celltrion Healthcare’s share prices are oversold. 

• Hugel is a solid turnaround story. The recent resumption of its Botulax product sales in China is likely to boost the company’s sales and profits in 2023 and 2024.
• Despite this important catalyst, Hugel continues to face potential legal battle with Medytox over the botulinum toxin-related patent in the United States.
• The overall valuation on Hugel remains attractive and it is trading at EV/EBITDA of 7.1x and P/E of 18.2x in 2023.

• Hugel Inc (145020 KS) is expected to start shipment of Botulax to China this month. Moreover, the company will launch its HA filler in China by middle of 2023.
• Hugel plans to focus on expanding into the global market in 2H23. The company began full-scale sales of Botulax in Australia in April and plans to enter Canada this year.
• Preliminary ruling regarding legal dispute in US is expected in November, while final ruling will come in March 2024. Hugel pushed back its US entry to 2025.  

• Baiyunshan is not a typical TCM company. As Great Commerce accounts for the majority of revenue, it clearly drags down the quality of total assets and growth expectation for valuation.
• As Jin Ge and Wang Lao Ji are facing different challenges, the overall growth/profitability of Baiyunshan is under pressure.Due to uncompetitive product line, Baiyunshan’s future growth appears to lack momentum.
• The valuation of Baiyunshan-A share is still expensive, but Baiyunshan-H share is attractive. After all, the future consumption recovery would be beneficial for boosting Baiyunshan’s valuation. Then, trading opportunity occurs. 

• In this insight, we take a look at the names leading the race to become ADDs/DELs for the DAX, MDAX, and SDAX Indices in the September 2023 Rebalance.
• Software AG (SOW GR)‘s takeover situation could result in intra-review index changes prior to the September 2023 rebalance. 
• Fresenius Medical Care (FME GR) and Deutsche Lufthansa AG (LHA GR) are close to becoming DAX ADDs as they require very small price gains to trigger Fast Entry additions.

• Medley (4480 JP) started 2023 on a strong note, with 1Q23 revenue increasing 56% YoY to ¥4.4B, mainly driven by 83% YoY revenue growth in medical platform business.
• Despite better-than-usual progress in Q1 result, Medley did not change 2023 guidance. However, the company sees a strong possibility of surpassing 2023 profit targets at the EBITDA level and below.
• Medley has revised its mid-term target and brough forward the timeline for achievement of the goals by one year. The company now aims to achieve revenue of ¥23B in 2024.

• KN046’s commercialization prospects is limited if it doesn’t demonstrate better results than PD-1 in head-to-head trial. The value of KN046 still lies in its potential to treat PDAC not sqNSCLC.
• KN026 is difficult to become a blockbuster variety. JSKN003 may not have good opportunity in front of DS-8201. Many investors are unhappy with Alphamab’s credibility and information disclosure quality.
• Alphamab’s valuation is already at low level. However, considering the current pessimistic sentiment towards biotech in HKEX, investors are advised to remain cautious, and just short-term trade is recommended.