Health Care Archives | Page 71 of 137 | Smartkarma

• Volpara Health  (VHT AU), which makes software enabling the early detection of breast cancer, has announced it has entered into a Scheme Implementation Deed with South Korea’s Lunit (328130 KS).
• Lunit is offering Volpara shareholders A$1.15/share, in cash, a 47.4% premium to last close. Cornerstone investors with 25.92% of shares out are supportive. As is Volpara’s board.
• The Scheme Meeting is expected to be held in 2Q24. The transaction requires NZ’s OIO approval.

• Volpara Health Technologies (VHT AU) has entered a scheme implementation deed with Lunit (328130 KS) at A$1.15 per share, a 48.4% premium to the undisturbed price of A$0.775 (13 December).
• The offer is subject to several conditions, such as shareholder and OIO approval. Irrevocables and directors represent 33.30% of outstanding shares. 
• Barring a competing offer, this is a done deal, as the offer is attractive. At the last close and for the end of May payment, the gross/annualised spread is 5.0%/11.6%.

• Local news reported two positive developments for Zai Lab’s FcRn inhibitor Efgartigimod: (1) Rival CSPC/HarbourBio withdrew BLA for competing drug Batoclimab (HBM9161), (2) Efgartigimod was included in 2024 NDRL;
• We raise Zai Lab’s 2024 top line by 8.8% but keep non-GAAP operating loss largely unchanged；
• We raise TP by US$2 to US$20 and maintain SELL.

• Astellas Pharma (4503 JP) has been reporting a couple of positive developments over the last one month. These are right steps toward achieving sustainable and accelerated growth in long-term.
• Astellas received European Commission approval for Veoza for the treatment of moderate to severe vasomotor symptoms associated with menopause. This potential blockbuster drug has already been launched in the U.S.
• Astellas is acquiring Propella Therapeutics for $175 million. Propella’s clinical-stage lead candidate can be a challenger to the current standard-of-care in prostate cancer treatment.

• Rain Oncology (RAIN) is being bought out for $1.16 + CVR worth up to $0.17/share.
• This seems like a worse deal than the $1.25 + CVR Tang was offering, but ok, I will take it.
• Usually these CVR’s should be valued at a large discount to their upper value, so I see no reason to hang around in this one so closing this one for a 15% gain at $1.

• A company that does’t include a cash flow statement in its 1Q and 3Q financial summaries, which will now be mandatory, is a company that is reluctant to disclose information.
• Management groups have called for making quarterly disclosure voluntary. This time, a hand has been dealt with a compromise proposal to unify quarterly reports and financial statements in securities reports.
• While the risk of dropping quarterly disclosure in the near future is small, the major problem is that some managers are still reluctant to disclose information.

• Diseases with complex mechanisms like NASH are unlikely to be solved by drugs with a single target, but compared with THR-β and GLP-1s, our view on HTD1801’s prospects is negative.
• HTD1801 faces high R&D failure risk and challenges in obtaining the final approval for NASH indication. For T2DM indication, the current intense competitive landscape has dimmed its future commercialization prospects.
• Several original shareholders have already cashed out in advance, indicating that they are not optimistic about the prospects of HighTide. The valuation premium space after IPO could be lower-than-expected.

Recce Pharmaceuticals raised A$11.0m (gross) in September and October. Most of the proceeds (A$6m) will be directed towards the company’s clinical programmes for lead anti-infective candidate RECCE® 327 (R327), including the ongoing Phase I/II study of the IV formulation in healthy volunteers and in patients with uncomplicated or recurrent urinary tract infections (UTIs). This study continues to advance, with the company recently dosing healthy subjects with the 3,000mg dose over a 15-minute infusion period, following a favourable safety review of this dose over a 30-minute infusion. We model that Recce is currently funded into CY24 and expect the company to seek additional funding, which may come from partnerships or non-dilutive arrangements. Following minor adjustments to our forecasts, we now obtain an rNPV valuation of A$551.1m (or A$2.71 per share), versus A$562.4m previously.

• Alkem Laboratories Ltd (ALKEM IN) is flying high on strong Q2 numbers. The shares rallied 23% since the company announced Q2FY24 result in early November, widely outperforming Nifty Pharma index.
• In Q2FY24, revenue grew 12% YoY, and gross margin expanded 380bps to 61.4% backed by lower raw material cost and lower intensity of price erosion in US market.
• For the U.S. business, Alkem is looking at high-single-digit growth in dollar terms for FY24. The company has reiterated FY24 gross margin guidance at 59.0–59.5%.

• Shineway’s performance growth in 23Q1-Q3 slowed obviously. The big decrease in sales growth of injection products and TCM formula granule products would drag down the overall revenue growth in 23H2. 
• Due to TCM formula granules VBP, the 60%-75% gross profit margin level is hard to sustain. TCM formula granules business would enter an era of low profits but high sales.
• Shineway’s cash balance is RMB5.4 billion, but market value is about RMB5.39 billion. So, Shineway is undervalued. The Company’s two dividends next year could reach RMB50 cents per share.

Immix presented encouraging new data at the American Society of Hematology (ASH) 2023 meeting for its Nexcella subsidiary’s lead CAR-T asset, NXC-201, in amyloid light chain amyloidosis (ALA) patients. The update corresponds to 10 ALA patients treated with NXC-201, for which the overall response rate (ORR) stands at 100% (10/10). NXC-201 also maintains its competitive safety profile among this group, including no cases of neurotoxicity and only low-grade cytokine release syndrome associated with short onset and duration. The results to date are supportive of NXC-201 potentially becoming the first outpatient CAR-T therapy, in our view, offering a potentially desirable treatment option for a fragile patient population. While the current data come from the NEXICART-1 trial based in Israel, with the Investigational New Drug (IND) application in ALA patients recently accepted by the FDA, we believe the enrolment of patients at US trial sites (NEXICART-2) will be a key milestone for the clinical progression of NXC-201. Management has communicated that it intends to submit a Biologics License Application to the FDA once 30–40 ALA patients have been treated.

OSE Immunotherapeutics (OSE) has shared a positive update on the FIRsT clinical trial assessing FR104/VEL-101 (an anti-CD28 monoclonal antibody) as a maintenance therapy for kidney transplant patients. Long-term maintenance therapy in kidney transplant patients remains an ongoing medical need that has seen little progression in the last 20 years. Although OSE is in the early stages of clinical development, we believe there could be a significant opportunity. Encouragingly, the results show no safety concerns with FR104/VEL-101 treatment (seven patients for 12 months post-transplantation, and one ongoing at four months) and no cases of acute rejection, both of which are key objectives for this Phase I/II trial. While the FIRsT study involves a relatively small group size (eight evaluable patients), we believe the update is encouraging, and note that Veloxis Pharmaceuticals (OSE’s partner for this programme) is already preparing for a subsequent Phase II trial involving a larger patient population. We expect full results from the FIRsT study after all patients have completed the 12-month treatment protocol, most likely in H224.

• Sigma Healthcare (SIG AU) has announced a potential merger with Chemist Warehouse Group (CWG) to create a leading healthcare wholesaler, distributor and retail pharmacy franchisor.
• With a market cap of ~A$8.5bn and a free float market cap of ~A$4bn, the merged company will make the cut for inclusion in the S&P/ASX 200 (AS51 INDEX). 
• Inclusion in the S&P/ASX 100 Index looks just out of reach at the moment as does inclusion in some large global indices.

• Privately-Held Chemist Warehouse’s (CWG) “transformational merger” with pharmaceutical wholesaler and franchisor Sigma Healthcare (SIG AU) will result in CWG’s shareholders holding 85.75% of the merged company. 
• CWG shareholders will receive A$700mn in cash plus new Sigma shares. Sigma will also undertake a $400mn equity raising to fund working capital needs.
• Sigma has the backing of its largest shareholder HMC. The risk to completion pivots off ACCC approval. 

• A group of shareholders is looking to raise around US$600m via selling a 6.9% stake in Mankind Pharma.
• MP is a pharmaceutical company engaged in developing, manufacturing and marketing a range of pharmaceutical formulations across various acute and chronic therapeutic areas, as well as several consumer healthcare products.
• We have looked at the IPO and lock-up release earlier. In this note, we talk about the other deal dynamics.

• Pharmaron’s performance has shown a clear downward trend this year, and the growth in 23Q4 may be even lower. That means this year’s results could fall short of management’s expectations.
• The essence of unsatisfactory profit margin is due to low capacity utilization/management efficiency.The underlying reason is the sharp decline in drug R&D demand due to the deterioration of financing environment.
• Pharmaron seems ill-prepared in peptide CDMO, and its performance would further lag behind Wuxi AppTec in the future. Pharmaron may not be able to contribute alpha during industry downturns.

• The New and Better (5mos old) A-H Premium Tracker has tables, charts, measures galore to track A/H premium positioning, southbound and northbound positioning/volatility in pairs over time, etc.
• Hs with H/A pairs under-perform their As on average by 70+bp. Liquid HK H/A Pairs saw H/As -66bp. H/A Pair intracorrelation is down but it feels like liquidation.
• SOUTHBOUND and NORTHBOUND flows were buys, and sells, respectively, but Hs have had two bad weeks in a row, and high premia A/H pairs have seen premia rise significantly.

• Max Healthcare Institute (MAXHEALT IN) has entered into a share purchase agreement for acquisition of a 550-bedded Sahara Hospital in Lucknow, Uttar Pradesh for an enterprise value of INR9.4B (~$113M).
• The Hospital currently serves ~2 lakh patients every year, with FY24 revenue run rate of INR2B. It has a renowned center of excellence for Neurosciences.
• The Hospital has a potential to quickly ramp up beds in existing building and expand medical programs such as oncology, transplants, robotics, etc.  

• Now that the pandemic has passed, Yiling’s performance has to face a sharp decline due to the high base before, but in our view, the situation is not so bad.  
• According to the management,sales of cardiovascular and cerebrovascular products would gradually increase to make up for the sales decline of Lianhua Qingwen, which would still be higher than pre-pandemic level.
• About 15-20% performance growth is still reachable in the future. PE of 20-30 is a reasonable range for Yiling. Being included in CSI 300 Index helps to improve the liquidity.

• China’s innovative drug sector remains a liquidity driven sector, as investible choices are limited, which include Akeso and BeiGene as our BUY ideas.
• We also notice positive change in Innovent but opt to keep rating unchanged;
• We upgrade BeiGene from SELL to BUY and maintain SELL on RemeGen, Innovent, JUNSHI and ZaiLab. We discontinued coverage on Legend Biotech.

• We summarized some important opportunities and trends that we think would emerge in the pharmaceutical industry in the future.
• Considering the current unfavorable financing situation of Biotech in the domestic primary market, we anticipate that there would be significant discounts in the sale of equity in the future.
• Topchoice has not yet out of trouble. Most of its business diversification could end in failure. It is difficult to support high valuation only by one hospital and one region.

• In Q2FY24, Ipca Laboratories (IPCA IN) reported 10% growth in domestic formulation business, driven by 12% growth in pain management. In FY24, domestic formulation is expected to growth 12–14%.  
• Ipca now holds 52.67% stake in Unichem Laboratories (UL IN). Ipca is confident to clock revenue of INR1.7–1.8B and EBITDA of INR300M from Unichem within two years of acquisition.
• As facilities are back onstream, Ipca is augmenting the supply chain and revalidating of all the formulations and updating them. Shipment to the U.S. may begin in Q1FY25.

• In Q2FY24, Avid Bioservices (CDMO US) reported 27% YoY and 33% QoQ revenue decline to $25.4M, due to annual maintenance shutdown and reduction in process development services from early-stage customers.
• During Q2FY24, Avid Bioservices signed $35M in net new business orders from both new and existing customers, resulting in a record high backlog of $199M, up 35% YoY.
• Avid Bioservices has lowered FY24 revenue guidance to $137–147 million from $145–165 million. For reference, the company reported revenue of $149 million in FY23.

Shield Therapeutics’ US commercialisation efforts continue to gather steam, with prescription volumes gearing up in Q323 (27,750 prescriptions, a 76% sequential growth over Q2 and higher than the combined H123 figure of 26,284) and net selling price making a strong recovery after dipping in H123 (+24% to $148/prescription). US revenues grew to $4.1m, higher than the combined H1 figure of $3.7m. First-time prescribers grew 27% q-o-q and new prescriptions were up by 87%. More encouragingly, the clinical utility of Accrufer continues to be considered favourably by prescribers, reflected in the 77% repeat writers from Q223. Management has guided for FY23 total prescriptions to be between 100k and 130k, requiring a sequential growth of 65.6% at the lower end, which we see as undemanding given the Q3 run rate and growing momentum (as the expanded salesforce gets more entrenched). We maintain our full-year estimates and continue to value the company at £390.4m.

• Entero Healthcare Solutions Limited (2294842D IN) is looking to raise US$200m in its upcoming India IPO. The IPO will consist of both a primary and secondary component.
• Entero Healthcare Solutions (Entero) is a healthcare products distributor in India.
• In this note, we look at the company’s past performance.

• Aspira Women’s Health announced today that it has completed the design of the EndoCheck test based on the analysis of samples received from The University of Oxford in October.
• This data shows EndoCheck to be a high-performing blood test for localized endometriosis, including ovarian endometriosis masses known as endometrioma.
• Endometrioma is a localized form of endometriosis that has formed an ovarian mass. It is one of the most common types of endometriosis.

• This insight provides a detailed analysis of Eoflow’s appellant brief (released on 4 December) on Insulet Corp (PODD US)’s lawsuit. 
• We provide the following three major reasons why we believe Eoflow will win versus Insulet in this lawsuit.
• One of the most important arguments on Eoflow’s appellant brief is the DTSA three years statute of limitations.

• People think that third-party medical imaging service providers targeting the grassroots market would have considerable development potential.However, even overseas leading players haven’t formed large profit scale after decades of establishment.
• Different types of competitors would enter this market, and the consortium formed by public hospitals in grassroots market will be the biggest game changer. Potential legal risks also worth attention.
• The profit model is still unclear. It’s uncertain whether the anticipated sizeable scale will eventually materialise. There’s still a long way to explore the third-party imaging industry in China.

• Torrent Pharmaceuticals (TRP IN) reported 16% YoY revenue growth to INR26.6B in Q2FY24. Strong performance in India, Brazil, and Germany is partially offset by the revenue decline in the U.S.
• EBITDA increased 22% YoY to INR8.3, leading to 138bps YoY expansion in margin to 31%, due to cost optimization and discontinuation of the low margin business in the U.S.
• Initial bull thesis on the company regarding its domestic market strength is still intact. Further upside will be driven by superior performance in India and Brazil businesses and margin improvements.

• Eoflow (294090 KS) filed a 117-page appeal against the amended preliminary injunction (PI), sparking a 16% share price rally. Insulet Corp (PODD US) is required to respond by 14 December.
• Eoflow argues that the Massachusetts District Court committed legal errors. However, Eoflow’s arguments are rehashed from those that the district court has already dismissed with balanced counterarguments. 
• The appeal is Eoflow’s last roll of the dice. Eoflow’s appeal brief worryingly notes that the PI profoundly imperils both the Medtronic transaction and its status as a going concern.

• Japanese medical products maker Medikit Co Ltd (7749 JP) Tuesday announced a buyback of ~12% of its shares from the founder’s company.
• The stock is extraordinarily illiquid. 12mo ADV is <US$40k/day. But Medikit runs 40% gross margins, 20% EBIT margins, and trades at an EV/revenue ratio of ~0.8x. It’s cash-rich, and cheap.
• But it’s an interesting situation. The buyback (and its reason) combined with the shareholder structure allow me to idly speculate this is an MBO candidate.

• In November, Orthofix International Nv (OFIX US) named Massimo Calafiore as incoming President and CEO. Mr. Calafiore has extensive knowledge in orthopedics and spine, and M&A integration expertise.
• Orthofix has performed well and operated smoothly following management transition. In 3Q23, revenue increased 61% YoY on a reported basis and 1% YoY on a pro forma basis to $184M.
• The company expects to deliver much higher adjusted profits next year and to exit 2024 cash-flow positive from an estimated $100 million outflow for 2023.

• Against the backdrop of China’s reopen after the pandemic is under control, the performance comparison of the four major ophthalmic hospitals in the A-share market has attracted investors’ attention.
• Aier Eye Hospital is already going downhill. Bright Eye Hospital leads Huaxia Eye Hospital in national layout/growth rate. He Eye Hospital has a big gap compared to the rest three.
• The “weaknesses” of Huaxia and He Eye Hospital in business layout isn’t obvious currently.But in good times, the impact of businesses with strong consumption attributes on performance would be amplified.

• MariMed has begun manufacturing and processing cannabis products in its new kitchen in Mount Vernon, Illinois.
• As often happens in cannabis, there were construction and regulatory delays, but the company expects to have its award-winning edibles in Illinois stores in time for the holidays.
• Illinois is the sixth-most populated state with 12.7 million residents.

• Unveiling INM-089 targeting AMD. InMed is expanding its rare cannabinoid cannabinol (CBN)-based ocular disease treatment pipeline with INM-089, targeting age- related macular degeneration (AMD).
• INM-089, a CBN analog, is InMed’s second ocular pharmaceutical program, with the company currently engaged in pre-clinical studies of INM-088, investigating its effects in the treatment of glaucoma.
• InMed’s ocular programs target leading causes of severe eyesight loss and blindness.

Oryzon has announced the receipt of a $0.5m grant from the Amyotrophic Lateral Sclerosis (ALS) Association to support the regulatory clinical development of the company’s histone deacetylase 6 (HDAC6) inhibitor, ORY-4001, as a potential treatment for ALS. We view this as a favourable advancement that enables the company to expand its preclinical pipeline. This news of this funding grant follows on the heels of Oryzon’s recently announced €45m convertible financing arrangement. Oryzon plans to progress ORY-4001 through various investigational new drug (IND)-enabling studies and we anticipate updates from the company as the data become available. The most significant upcoming catalyst for Oryzon is top-line readouts for the Phase IIb PORTICO trial for lead clinical asset vafidemstat for the treatment of borderline personality disorder, expected in Q124.