Health Care Archives | Page 93 of 137 | Smartkarma

Shield Therapeutics reported its FY22 preliminary results and Q123 business update, the key emphasis of which was the growing traction of Accrufer in the US following the December 2022 co-commercialisation deal with Viatris. The FY22 revenue of £4.5m (+194% y-o-y) was driven by Accrufer US sales (£2.9m vs £0.1m in FY21) and underpinned by a material q-o-q growth in prescriptions during FY22 (25,200 vs 2,500 in FY21). Encouragingly, this trend has continued in Q123 (10,500 prescriptions; +12% q-o-q growth) despite initial operational disruptions related to the integration. With the salesforce approaching full strength (total 100 people) by May, we anticipate H223 to be a vital period for sales traction and market coverage. We have updated our FY23–24 pricing and costs estimates for the FY22 results but maintain our long-term Accrufer growth assumptions. Our revised valuation is £388.9m (£403.4m previously).

• The cloud hospital platform services serve as “the entry point” of Neusoft Xikang’s overall solutions, but the restrictions imposed by cities would affect the scalability of business.
• The variety of 2B objects and the diversity of medical scenarios covered would be conducive to the transformation to 2C business, resulting in stronger user stickiness and more monetization opportunities.
• Xikang’s 2B business is weaker than ClouDr. Financial performance would finally reflect the effectiveness and rationality of business model. Xikang’s valuation should be lower than ClouDr and Ping An Good Doctor.

• In my previous insight in Mid-March 2023, we had a look at the potential index changes and the resultant capping flows for the HSCEI Index in June 2023.
• Since then, our flow expectations have changed with changes in prices and/or float and total share counts.
• Here are our latest flow expectations based on the current prices.

• Aier’s performance slowed significantly in 2022, with revenue and net profit growth rates at their lowest in nearly a decade.Although performance rebounded in 23Q1, the growth rate lags behind peers.
• In front of increasing competition and difficulty of finding good acquisition targets, Aier’s poor operational capabilities and endogenous growth cannot support rapid growth. The beautiful story has shown obvious cracks.
• Future single-digit growth is inevitable. Aier is significantly overvalued due to problematic long logic. It should be noted that there would be four further holdings reductions for Aier this year.

• The government has started to encourage social capital to run hospitals. By entering the market that haven’t been fully covered by public hospitals, LDP has large development space theoretically.
• The current gross profit margin of LDP isn’t satisfactory. Together with continuous expansion of new hospitals with large investment, LDP could face either continuous loss or very low profit margin.
• China’s high degree of regulation depresses medical service price.The benefit chain of hospitals is complicated.In essence, an industry with low level of terminal payment is hard to generate high profits.

Incannex has released its Q323 cash flow report, providing key operational highlights. Clinical developments during the quarter included a positive interim review of its Phase II Psi-GAD trial (assessing psilocybin for generalized anxiety disorder (GAD)), initiation of the Phase II trial of IHL-675A (for treatment of rheumatoid arthritis (RA)), and continued progression of the BA/BE study for its lead asset IHL-42X (for obstructive sleep apnea). In a new development, Incannex announced the commercial launch of psychedelic-assisted psychotherapy clinics for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD), with plans to scale across Australia. Though we have low visibility on the prospects of the clinics currently, if they materialize, they may support the company’s cash inflows in the medium term. With a cash balance of A$37.1m at end-March 2023 and at the current quarterly burn rate (A$4.3m), management has guided that operations are funded into CY25.

• 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.
• MariMed has a long track record of strong financial performance.

Paradigm has shared its March 2023 quarterly update. In Q323, net cash outflow from operating activities was A$10.3m (A$28.1m for the first nine months of FY23). R&D costs amounted to A$9.0m, attributed to ongoing recruitment and analytical activities for the PARA_OA_008 Phase II clinical trial assessing injectable pentosan polysulfate (iPPS, or Zilosul) as a potentially disease-modifying treatment for knee osteoarthritis (kOA), site operations for Phase II studies in mucopolysaccharidosis (MPS I and MPS VI), and ongoing NDA-enabling non-clinical studies. This expenditure is comparable to the prior quarter (A$13.2m), and we anticipate an increase in burn rate in the near-term to support the company’s active pipeline. With a cash position of A$73.2m at end-Q323 and at the current quarterly burn rate, management estimates that operations remain funded into CY24.

Actinogen’s Q323 update reiterated the company’s focus on advancing its lead asset Xanamem. Patient recruitment in the Phase IIa XanaCIDD study in cognitive impairment (CI) associated with major depressive disorder (MDD) is ongoing, and the company plans to start the Phase IIb portion of the XanaMIA study in Q2 CY23 in the company’s lead indication, Alzheimer’s disease (AD). This study portion is designed to assess Xanamem in a population of patients with mild CI and/or mild AD, who at baseline will have been confirmed as biomarker-positive for progressive AD. We continue to see the results from the XanaCIDD study (expected in late CY23 or early CY24) as the next major clinical data milestone and a potential share price catalyst. We expect the company’s A$12.3m cash balance at 31 March to fund operations into Q4 CY23.

Having completed the required 38 implantations in late 2022, Pixium Vision’s key upcoming clinical milestone is the primary efficacy data, expected in or around year-end 2023, from the PRIMAvera European pivotal study assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company’s FY22 results showed a milder operating loss than expected, coming in at €11.9m, below our €12.5m estimate. Pixium has since taken further steps to curb its cash burn rate, and it now expects its funds on hand (€4.7m gross cash as of 31 March) to last until approximately the end of July, versus its prior guidance of June 2023. It is working actively to raise additional funds and has hired two investment banks to reach potential investors worldwide. We have rolled forward our estimates and given that we expect the company’s focus in 2023 and 2024 will be on preparing the Prima System for EU market approval and launch (which we continue to model in H125), we have pushed back our US commercialisation forecast by one year, to H227. We now obtain a pipeline rNPV valuation of €140.1m (vs €146.3m previously).

AFT Pharmaceuticals has announced that the US FDA has allocated a Prescription Drug User Fee Act (PDUFA) date for Maxigesic IV, an intravenous form of its flagship pain relief medicine. The PDUFA date is expected to be the last step in the FDA review process and has been set for 17 October 2023. It follows submission of additional requested data in April 2023 in response to the complete response letter (CRL) received from the FDA in July 2022 (related to queries about certain extractable and leachable compounds present in Maxigesic IV’s packaging) following the 2021 New Drug Application. The IV formulation is registered in 43 countries and has been launched in more than 19 (including the key markets of Germany, France and Italy), but the US is expected to be a key high-margin market. We note that Maxigesic IV was out-licensed to Hikma Pharmaceuticals in the US in 2021 for up to NZ$18.8m in proceeds.

• Cigna Corporation delivered a mixed performance in the last quarter with below-par revenues but an earnings beat.
• Through a mix of dividends and share repurchases, Cigna returned $9 billion to shareholders.
• Furthermore, in Evernorth Care Services, Cigna enhanced and expanded its care management and care delivery skills portfolio.

• Astellas Pharma (4503 JP) is acquiring the U.S.-based clinical stage biopharmaceutical company IVERIC bio (ISEE US) for ~$5.9B. Iveric Bio focuses on the discovery and development of novel ophthalmology treatments.
• Iveric’s lead drug candidate Avacincaptad Pegol for the potential treatment of Geographic Atrophy is under FDA review with PDUFA action date of August 19, 2023.
• The acquisition will be funded by a combination of bank loan, issuance of commercial paper totaling ~¥800B, and internal cash. The acquisition is expected to complete by 3Q23 (July–September).

• M3 Inc (2413 JP)  reported 4QFY03/2023 results on Friday. Both revenue and OP increased 3.1% and 52.0% YoY to ¥55.7bn (vs consensus ¥60.8bn) and ¥16.0bn (vs consensus ¥17.8bn) respectively.
• We previously raised concerns over slowdown in medical platform earnings, and it seems that m3 has not been able to generate meaningful growth from its overseas businesses.
• The company expects FY03/2024E revenue growth to further drop to about 8.3% marking the slowest annual increase in revenue over the last two decades.

• Japanese drug maker Astellas Pharma announced on Monday that it has entered into a definitive agreement to acquire 100% of opthalmalogy player Iveric Bio for a total consideration of U$5.9bn.
• Astellas Pharma (4503 JP) will pay US$40 per share of IVERIC bio (ISEE US) , 64% premium to the unaffected closing price of US$24.33 per share as of 31st March 2023.
• As Astellas’ blockbuster drug XTANDI’s exclusivity is nearing expiry, we think Iveric’s key drug asset ACP should offer some protection over loss of XTANDI’s revenues in the future.

• In 2022, Hygeia maintained stable revenue growth but with lower-than-expected profit performance. We think Hygeia’s profitability would improve gradually in the future as more and more new hospitals become break-even.
• Different from Aier/Topchoice, Hygeia’s acquired hospitals would be directly incorporated into the listed company, which means all aspects of consideration would be prudent. This is clearly more beneficial for investors/shareholders.
• Hygeia’s business model has proven to be replicable.The implementation of DRG policy has no significant impact on profitability. Hygeia is expected to have higher valuation than Aier/Topchoice in the future.

• Torrent Pharmaceuticals (TRP IN) continues to report double-digit revenue growth from India business. Leadership positioning in chronic therapeutic areas underpinned by Curatio acquisition is driving the domestic business.
• The company expects the India business to continue its growth momentum, backed by new launch, top brand performance, increase in field force productivity, and continued performance of Curatio portfolio.
• The U.S. business also witnessed revival in FY23 after a downturn in FY22, which should provide impetus to the company’s bottom line to a great extent.

• The real foothold of a pharmaceutical company lies in  “Development” rather than “Research”. After the clinical development has reached the first-class level, what remains is the vision of the leaders.
• For China biotech, we think they would go through four stages- Stage 1 (2015 – 2019), Stage 2 (2019 – present), Stage 3 (2026-2028) and Stage 4 (starting from 2030).
• If without Merck’s deal, Kelun’s profit improvement was mainly due to effective cost control. If Kelun could maintain double-digit revenue growth, with net profit margin around 10%, it’s already good.

• Siloam International Hospitals (SILO IJ) booked a very strong set of 1Q2023 results, despite a seasonally slower period, with all of its ramping-up hospitals now generating positive EBITDA.
• The company saw marked improvement in its patient metric in 1Q2023, both for inpatients and outpatients plus an improving payee mix with more corporate and insurance payments.
• Siloam put through price increases in 1Q2023, which will positively impact the next few quarters. It will also focus more on diagnostics this year as a new area for growth.

• Astellas Pharma (4503 JP) recorded 17% growth in revenue to ¥1,519B in FY23, driven by 24% growth of Xtandi. Core operating profit grew 17% and core net profit increased 18%.
• The company has guided for flat revenue and core operating profit for FY24, mainly due to negative impact of Fx.  
• Astellas expects to obtain FDA approval for fezolinetant for vasomotor symptoms associated with menopause in May 2023. The company will file for marketing approval for zolbetuximab in Q1FY24.

• AstraZeneca achieved mixed results in the last quarter with total revenues surpassing Wall Street expectations but it missed out on meeting the earnings expectations of analysts.
• The company had a total revenue of $44.4 billion in 2022, a 25% increase at CER, while core EPS was $6.66, a 33% increase from 2021 levels.
• Looking ahead to 2023, AstraZeneca remains confident that the strength of its underlying portfolio will allow it to outgrow revenue decreases from its COVID-19 medicines.

• Exact Sciences Corporation delivered strong results in the quarter, with fourth quarter revenue increased by 17%, or 28%, excluding COVID testing, to $553 million.
• The company delivered an all-around beat in the quarter as 10,000 new healthcare professionals ordered Cologuard, bringing the total to over 302,000.
• Besides that, Precision Oncology’s revenue fell 4% to $143 million, excluding the loss of the company’s prostate business and a $2 million forex headwind increase of 1%.

• McKesson Corporation delivered a mixed set of results for the last quarter with revenues below expectations but it did manage an earnings beat.
• Revenues in the Prescription Technology Solutions sector were $1.1 billion, up 9% yearly, due to higher prescription volumes, quicker growth in the company’s third-party logistics business, and higher technology service revenues.
• In the last quarter, McKesson also made significant progress in developing its oncology and biopharma ecosystems.

Immix Biopharma continues to share encouraging data from the Phase Ib/II open-label NEXICART-1 trial. This study is investigating NXC-201, a CAR-T therapy, for the treatment of multiple myeloma (MM) and light chain amyloidosis (ALA). At the European Society for Blood and Marrow Transplantation 49th Annual Meeting in Paris, Immix announced positive results for the 58 patients enrolled so far. An overall response rate (ORR) of 92% was reported for patients with MM, and an ORR of 100% for patients with ALA. The therapy has also continued to show a favorable safety profile, building on a comprehensive data package to support NXC-201 as the first potential outpatient CAR-T therapy, offering significant market differentiation, in our view. Management plans to submit a biologics license application (BLA) for FDA approval in MM once 100 patients have been treated, and in ALA once 30–40 patients have been treated.

• Intuitive Surgical managed an all-around beat in the last quarter with decent revenue and products growth.
• The new capital installs were quite strong, with customers building their Ion and da Vinci system capabilities.
• A capable product portfolio and strong growth in procedures have supported quite a healthy capital placement quarter.

Respiri released its Q323 activity report, updating investors on key highlights during the quarter. The period was marked by continued expansion of the company’s commercial footprint in the US, which included the signing of three additional contracts (taking the total client count to nine) and the appointment of a US-domiciled chief commercial officer to spearhead its growth strategy for the country. In addition, Respiri disclosed that it is in ongoing negotiations with two large insurers and four to six healthcare organisations, indicating a strong sales funnel. With the company recognising its first Centers for Medicare & Medicaid Services (CMS) reimbursement claims during the quarter and an increasing number of patients onboarded (including at Michigan Children’s Hospital and an undisclosed North Carolina-based healthcare organisation in Q123), we see initial validation for the company’s wheezo remote patient monitoring (RPM) model with subsequent traction likely with early patient responses. The period-end cash balance stood at A$0.9m, highlighting the need to raise capital in the near term, pending any material sales-related inflows.

• JPX-Nikkei 400 is composed of common stocks listed on the Tokyo Stock Exchange. It is a free-float-adjusted market-value-weighted (capped) index composed of 400 constituents.
• A periodic review is conducted by the Index providers, the JPX Group and Nikkei Inc, in August every year. We look at the potential forward inclusions and removals every month.
• Below is a look at potential Inclusions and Removals for the JPX-Nikkei 400 Rebalance to come in August 2023 based on trading data as of end-April 2023.

• Samsung Biologics (207940 KS) reported year-over-year improvement in sales and operating profit in 1Q23. However, net profit declined 4% YoY due to one-off factor stemming from an acquisition last year.
• The company expects stronger growth in H2 due to revenue contribution of Plant 4 and the launch of Humira biosimilar in the U.S.  
• Based on the strength of CMO business, Samsung Biologics has raised 2023 revenue growth guidance to 15–20% YoY from 10–15% YoY announced in January.

OpGen has announced that Curetis (its German subsidiary) has successfully met the remaining key milestones for Unyvero A30 RQ under the initial R&D collaboration with FIND (a global non-profit alliance for diagnostics), triggering a $0.3m milestone payment to OpGen. This development follows the achievement of certain other key milestones in January 2023. While OpGen is still working on the next set of deliverables under the expanded scope of R&D agreement (April 2023), the successful completion of the feasibility phase indicates Unyvero’s potential adaptability for low- and middle-income countries (LMICs). As a step forward, OpGen will seek to expand the agreement towards clinical studies and subsequent commercialization.

• Kenvue (KVUE US), a wholly owned subsidiary of Johnson & Johnson (JNJ US), is preparing for an IPO of 151M shares. The IPO price is expected to be $20–23/share.  
• Goldman Sachs, J.P. Morgan, and BofA Securities are acting as joint lead bookrunning managers for the IPO. J&J will still own more than 90% of Kenvue’s shares after the IPO.
• In 1Q23, Kenvue’s revenue increased 7% YoY to $3.9B, driven by a 12% YoY revenue growth in self-care OTC products. Adjusted net income increased 3% YoY to $630M.

• ASRT is purchasing Spectrum Pharmaceuticals (SPPI) in an all-stock transaction that adds ROLVEDON to its product portfolio.
• The initial reaction to the deal has been materially negative after ASRT added it would maintain a majority of SPPI’s operating expenses.
• ASRT’s management has been looking for an asset that would help diversify the revenue stream away from Indocin. The purchase of SPPI achieves such a goal

• Dechra is in discussions with EQT and ADIA about a 4,070 cash possible offer (46.6% premium, 22.6x EV/NTM Fwd EBITDA and 32x Fwd P/E). PUSU deadline is 11 May. 
• With the deal multiple at a slight premium (on both EV/Fwd EBITDA and Fwd P/E) over Zoetis, the market leader in animal health, the offer appears to be reasonably priced.
• My base case fair value estimate is 3,568p/share (DCF-based), 12.3% below the offer price. My TP is thus 4,070p. Gross spread is 9.1%, therefore I feel the risk/reward is balanced.

• Baxter International’s fourth quarter performance fell short of the expectations of its management as well as Wall Street.
• Foreign exchange losses and the product mix throughout the quarter were the primary reasons for a rather disappointing result.
• Sales during the fourth quarter were $3.9 billion, increasing 2% operationally, 17% at constant currency, and 11% reported-on-basis.

• InMed is a unique clinical-stage biopharmaceutical company that is engaged in the research and development (R&D) of rare non-psychoactive cannabinoids for therapeutic use.
• The company is stewarded by a strong leadership team led by CEO Eric A. Adams
• InMed’s growing development pipeline is at the forefront of pharmaceutical companies that are harnessing rare cannabinoids for treating a range of disorders with unmet medical needs.

• Teleflex had a mixed quarter with revenues of $758 million that was below Wall Street expectations given a year-over-year fall of 0.5%.
• Despite an unanticipated subcomponent supply chain issue in their Surgical business, their fourth quarter constant currency revenue growth remained steady.
• Teleflex’s Interventional, Surgical, and OEM product categories produced double-digit constant currency year-over-year revenue increase.

• Mankind Pharma (6596876Z IN) is looking to raise up to US$526m in its IPO by selling 40.06m shares at a price range of INR 1026 to INR 1080 per share.
• The company has allocated 12.02m shares to anchor investors at INR 1080/share. That list includes marquee names and the lock-up reduces near-term float.
• The IPO opens on 25 April and will close on 27 April. Shares are expected to start trading on 9 May and there are no near-term index inclusions expected.

• With 3 trading days left in the review period for the June rebalance, we see 8 potential changes and 2 close adds for the KOSDAQ 150 Index (KOSDQ150 INDEX). 
• There are two potential transfers from the KOSDAQ Market to KOSPI Market that could lead to more changes in May and/or June.
• Nearly all potential deletions are trading near their lows and short interest has been increasing on some of the stocks. That will be covered closer to implementation of the rebalance.

• The SPX made a high of 4169 last week, tagging our 4165-4200 resistance range. We still believe 4165-4200 will cap upside in 2023, with a reach to 4300-4325 also possible.
• Considering limited upside in both scenarios, and with the seasonably weaker “sell in May and go away” period approaching, we continue to recommend higher allocations to defensives
• This includes Utilities (XLU, RYU), Consumer Staples (XLP), Health Care (XLV, PPH), and gold miners (GDX).

• UMP Healthcare (“UMP”) is Hong Kong’s leading private medical service network. Its network spans 1100+ service providers, 1mm+ scheme members, 2000+ contract customers, and over 1.13mm+ annual clinic visits.
• Despite the consistent track record, UMP trades at a 61% discount to its IPO price, 6x PE, and 8% yield with 45% of its market cap in net cash. 
• We see ingredients in place for a multi-year re-rate, backed by HK’s new Healthcare Policy and the company’s strategic tilt towards higher margin service lines supporting future profit growth.

• Excluding COVID-19 projects, some of WuXi AppTec’s conventional CXO business growth rate has declined significantly. So, the fading of COVID-19 dividend period is not the only reason for the performance decline.
• The supply-side reform of innovative drugs is further deepened, and the effect of industry clearing is obvious. So, the “winner-takes-all” logic will be gradually deduced in the future.
• WuXi AppTec’s controlling shareholders seem to “have foreseen something”- They could continue to reduce holdings on rallies in the future. Together with longer-than-expected industry winter, valuation center could further decline.

• The margins of pharmaceutical circulation B2B business is low. If there’s not enough incremental space of terminal customers, the simple B2B trading model is difficult to form a leapfrog growth.
• Based on YSB’s business model, if terminal customers choose to use other platforms like JD Health/Alibaba Health, etc., YSB would face the risk of losing upstream and downstream users.
• So far, we haven’t seen that YSB has established core competitiveness or moat to secure the terminal customers pool, casting doubts on its business model, investment logic and outlook.

• Esco Lifesciences Group (1891571D SP), a profitable lifesciences tool provider with a global presence, is looking to raise $300M in its upcoming HK IPO.  
• The company clocked revenue of S$117M in 2019, which steadily rose to S$155M in 2020 and S$172M in 2021, representing CAGR of 21%, outpacing lifesciences equipment market growth of 10%.
• In May 2021, Esco raised $200M through series-A fund raising with investors holding nearly 24% of the shares. This puts its valuation at around $840M.

• Johnson & Johnson reported strong operational performance in the quarter, demonstrating the power and adaptability of Johnson & Johnson as well as its dedication to enhancing global health outcomes.
• They also anticipate a number of pipeline advances in 2023 that will boost confidence in their Pharmaceutical and MedTech companies.
• Johnson & Johnson remains confident in its ability to generate near-term success, long-term growth, and shareholder value creation in the future.