Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/eisai-co-ltd" target="_blank" data-smartkarma-citation="entities:21001:1" rel="noopener">Eisai Co Ltd (4523 JP)</a> is expected to receive full approval from the FDA for Alzheimer’s disease drug, Leqembi, as FDA advisory committee voted unanimously in support of the drug.  </li>
<li>Leqembi application has been granted Priority Review, with PDUFA action date of July 6. Once the FDA grants traditional approval, broader Medicare coverage for Leqembi would begin the same day.</li>
<li>Leqembi is expected to receive approval in Japan, EU, and China in FY24. With these approvals, Leqembi is expected to become the top selling Alzheimer’s disease drug globally.</li>
</ul>



Eisai Co Ltd (4523 JP) is expected to receive full approval from the FDA for Alzheimer’s disease drug, Leqembi, as FDA advisory committee voted unanimously in support of the drug.  
Leqembi application has been granted Priority Review, with PDUFA action date of July 6. Once the FDA grants traditional approval, broader Medicare coverage for Leqembi would begin the same day.
Leqembi is expected to receive approval in Japan, EU, and China in FY24. With these approvals, Leqembi is expected to become the top selling Alzheimer’s disease drug globally.


Eisai Co (4523 JP): Alzheimer’s Drug Approaching Full FDA Approval; Other Countries to Follow Soon

<ul>
<li>
<a href="https://www.smartkarma.com/entities/medipal-holdings-corp" target="_blank" data-smartkarma-citation="entities:18394:1" rel="noopener">Medipal Holdings (7459 JP)</a> announced strong FY23 result, with year-over-year improvement in sales and profit. While sales were just 1% ahead of forecast, net profit exceeded the guidance by 16%.</li>
<li>Outperformance was mainly driven by PALTAC business. Revenue from PALTAC increased 6% YoY to ¥1,104B, 2% ahead of forecast of ¥1,080B, fueled by 14% growth in OTC pharmaceutical products.</li>
<li>Medipal has guided for accelerated revenue growth of 3% YoY for its pharmaceutical wholesale business in FY24. In FY23, the business recorded revenue growth of 0.6% YoY.</li>
</ul>



Medipal Holdings (7459 JP) announced strong FY23 result, with year-over-year improvement in sales and profit. While sales were just 1% ahead of forecast, net profit exceeded the guidance by 16%.
Outperformance was mainly driven by PALTAC business. Revenue from PALTAC increased 6% YoY to ¥1,104B, 2% ahead of forecast of ¥1,080B, fueled by 14% growth in OTC pharmaceutical products.
Medipal has guided for accelerated revenue growth of 3% YoY for its pharmaceutical wholesale business in FY24. In FY23, the business recorded revenue growth of 0.6% YoY.


Medipal Holdings (7459 JP): Better-Than-Expected FY23 Result; Accelerated Growth Expected in FY24

<ul>
<li>
<a href="https://www.smartkarma.com/entities/astellas-pharma-inc" target="_blank" data-smartkarma-citation="entities:6091:1" rel="noopener">Astellas Pharma (4503 JP)</a> 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%.</li>
<li>The company has guided for flat revenue and core operating profit for FY24, mainly due to negative impact of Fx.  </li>
<li>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.</li>
</ul>



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.


Astellas Pharma (4503 JP): FY23 Result and FY24 Guidance Meet Expectation; New Drugs Hold Key

Pan-Asia Catalysts/Events, Quiddity Advisors

Travis Lundy

Pan-Asia Catalysts/Events

Quiddity Advisors

Event-Driven

<ul>
<li>Last week (on 10 February), <a href="https://www.smartkarma.com/entities/canon-inc" target="_blank" data-smartkarma-citation="entities:1:1" rel="noopener">Canon Inc (7751 JP)</a> announced it intended to delist its ADRs from the NYSE.</li>
<li>Canon is the third Japanese company to do so in two months, after <a href="https://www.smartkarma.com/entities/eisai-co-ltd" target="_blank" data-smartkarma-citation="entities:21001:1" rel="noopener">Eisai Co Ltd (4523 JP)</a> announced in December and <a href="https://www.smartkarma.com/entities/olympus-corp" target="_blank" data-smartkarma-citation="entities:356:1" rel="noopener">Olympus Corp (7733 JP)</a> in January.</li>
<li>No related investment opportunity but there may be a trade to do.</li>
</ul>


Last week (on 10 February), Canon Inc (7751 JP) announced it intended to delist its ADRs from the NYSE.
Canon is the third Japanese company to do so in two months, after Eisai Co Ltd (4523 JP) announced in December and Olympus Corp (7733 JP) in January.
No related investment opportunity but there may be a trade to do.


Canon ADR Cancellation - There May Be A Trade To Do

<ul>
<li>
<a href="https://www.smartkarma.com/entities/eisai-co-ltd" target="_blank" data-smartkarma-citation="entities:21001:1" rel="noopener">Eisai Co Ltd (4523 JP)</a> received speedy regulatory nod for Alzheimer’s drug LEQEMBI. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or dementia stage of disease.</li>
<li>LEQEMBI will be available during or before the week of January 23, 2023. Eisai decided to price LEQEMBI at WAC of $26,500 per year to promote broader patient access.</li>
<li>Eisai has submitted a supplemental Biologics License Application to the FDA supporting the conversion of the Accelerated Approval of LEQEMBI to a traditional approval.</li>
</ul>



Eisai Co Ltd (4523 JP) received speedy regulatory nod for Alzheimer’s drug LEQEMBI. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or dementia stage of disease.
LEQEMBI will be available during or before the week of January 23, 2023. Eisai decided to price LEQEMBI at WAC of $26,500 per year to promote broader patient access.
Eisai has submitted a supplemental Biologics License Application to the FDA supporting the conversion of the Accelerated Approval of LEQEMBI to a traditional approval.


Eisai Co (4523 JP): Alzheimer’s Drug Gets FDA Approval; Focus Is Now on the Path Forward

Japan

Kyowa Hakko Kirin Co.,Ltd. develops, manufactures, and markets pharmaceuticals. The Company's products include a protein produced by genetic recombination technology, an anti-anemia agent that attaches new sugar chains through partial modification of the amino acid sequence of human erythropoietin (EPO), and a glycoprotein, human erythropoietin.

Shionogi & Company Ltd., is a pharmaceutical company. The Company develops prescription & over-the-counter drugs and diagnostics.

ROHTO PHARMACEUTICAL CO., LTD. manufactures and markets pharmaceuticals and cosmetics products.  The Company's products include eyewash, bath soaps, gastrointestinal medicine, and hand cream.  Rohto Pharmaceutical also has a license agreement with its subsidiary, Mentholatum (US) to sell their brand products.  The Company also manufactures contact lenses and health foods.

Astellas Pharma Inc. is a pharmaceutical company committed to the therapeutic fields of Urology, Immunology including Transplantation and Infectious Diseases, Oncology, Neuroscience and DM Complications and Metabolic Diseases. With over 17,000 global employees, Astellas researches, develops, manufactures, and promotes its prescription drugs through subsidiaries in the US, Europe, and Asia

ONO PHARMACEUTICAL CO., LTD. manufactures and sells pharmaceuticals.  The Company mainly researches and develops prescription drugs.

SANTEN PHARMACEUTICAL CO., LTD. produces and sells ophthalmic medicine.  The Company manufactures a variety of products including eye drops and ointments. Santen Pharmaceutical also imports lenses and tools and equipment used by optometrists and produces anti-rheumatic drugs.

Nippon Shinyaku Co., Ltd. manufactures pharmaceutical and health foods products. The Company produces drugs for urinary, nerve, respiratory, and circulatory systems as well as analgesic and anti-inflammatory drugs.  Nippon Shinyaku also develops synthetic anti-bacterial agents.

TSUMURA & CO. manufactures and sells pharmaceutical products including Chinese medicines.  The Company also manufactures and sells bathing products, cosmetics, and other healthcare and toiletry products.  Tsumura & Co. sells its products in Japan and overseas markets.

HISAMITSU PHARMACEUTICAL CO., INC. produces and sells pharmaceutical products. The Company's main product is anti-inflammatory analgesic plasters and poultices sold under the brand name Salonpas.  Hisamitsu Pharmaceutical exports its products to North America and Southeast Asia.  The Company also researches and develops antibacterial products through its related company, RRF.

Sumitomo Dainippon Pharma Co., Ltd. mainly manufactures and markets pharmaceuticals for human and veterinary use. The Company also produces and sells livestock feeds, food additives, and chemical products, as well as conducts clinical pathology tests for animals. Sumitomo Dainippon Pharma conducts businesses across worldwide.

CSPC Pharmaceutical Group Limited, through its subsidiaries, manufactures and sells pharmaceutical products.  The Company's products include vitamin C, antibiotics and common generic drugs. The Company is also engages in the development of innovative drugs and antibiotics.

Catalent, Inc. provides delivery technologies and development solutions for drugs, biologics and consumer health products. The Company's oral, injectable, and respiratory delivery technologies address the diversity of the pharmaceutical industry including small molecules, large molecule biologics and consumer health products.

Cipla Limited manufactures and sells pharmaceutical and personal care products. The Company offers active pharmaceutical ingredients, and formulations in therapeutic areas, such as allergy, analgesic, anti malarial, anti-infectives, cardiology, dermatology and cosmeceuticals, diabetology, gastroenterology, steroids, iron chelators, nutritional products.

China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. manufactures and markets medicines, healthcare products, and medical instruments.  Through its subsidiaries, the Company also operates in pharmaceutical trading, printing, food manufacturing, real estate development, and provides medical services.

China Resources Sanjiu Medical & Pharma (000999 CH)

Intra-Cellular Therapies Inc. researches and develops biopharmaceutical drugs. The Company engages in the research and development of small molecule drugs to treat neuropsychiatric and neurological diseases and other disorders of the central nervous system. Intra-Cellular Therapies offers its products to the medical industry.

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. is a pharmaceutical company. Through its subsidiaries, the Company manufactures genetic medicines, Chinese traditional medicines, diagnostic products, and medical instruments, provides technology, marketing, and advertising services, as well as invests in import and export trading.

Shanghai Fosun Pharmaceutical (Group) (600196 CH)

Cadila Healthcare Ltd. manufactures, and markets healthcare solutions ranging from formulations, active pharmaceutical ingredients, vaccines, diagnostics, health and dietetic foods, animal healthcare to cosmeceuticals.  The Company's products are available in tablets, capsules, injections, liquids, dry syrups, powders, granules, and ointments.

Torrent Pharmaceuticals Ltd. manufactures bulk drugs and pharmaceutical formulations. The Company's formulations include cardio-vascular, psychotropic and anti-biotic drugs while its bulk drugs include atenolol, ciprofloxacin and norfloxacin. Torrent Pharmaceuticals has wholly owned subsidiaries in several regulated and less regulated international markets.

Dr. Reddy's Laboratories Limited provides a complete range of pharmaceutical services. The Company manufactures bulk drugs and formulations including verapamil and cephalexin. The Company also manufactures and exports molecules such as norfloxacin, ciprofloxacin, and varieties of semi-synthetic penicillin. The Company markets its products in India and around the world.

Lupin Limited manufactures bulk actives and formulations. The principal bulk actives manufactured by it include Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti-infectives) and cardiovasculars. The company also possesses competencies in phytomedicines, in which medicines are made out of plant and herbal resources supported by the discipline of modern medicine.

Eisai Co., Ltd. produces prescription drugs and medical equipment and sells mainly to sales agents and subsidiaries.  Through its subsidiary, Sanko Junyaku, the Company produces and sells diagnostic drugs.  Eisai also markets its products through related companies in the US, Europe, and Asia.  The Company also manufactures and sells foods, livestock feeds, chemical, and agrochemicals.

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Eisai Co Ltd (4523 JP)

Eisai Co (4523 JP): Alzheimer’s Drug Approaching Full FDA Approval; Other Countries to Follow Soon

The PDUFA action date for traditional approval of Leqembi for the treatment of Alzheimer’s disease has been set for July 6. Leqembi is expected to...

Tina Banerjee

Medipal Holdings (7459 JP): Better-Than-Expected FY23 Result; Accelerated Growth Expected in FY24

In FY23, Medipal Holdings’ revenue was 1% ahead of forecast, while net profit exceeded the guidance by 16%. The company guided for 3% YoY revenue...

Tina Banerjee

Astellas Pharma (4503 JP): FY23 Result and FY24 Guidance Meet Expectation; New Drugs Hold Key

Astellas reported double-digit revenue growth in FY23, while FY24 revenue is expected to be flat due to unfavorable Fx. Flagship Xtandi still has...

Tina Banerjee

Canon ADR Cancellation - There May Be A Trade To Do

Canon has announced the cancellation of its ADR programme. Canon will inform the NYSE today, will file Form 25 on 24 Feb, and terminate the...

Travis Lundy

Eisai Co (4523 JP): Alzheimer’s Drug Gets FDA Approval; Focus Is Now on the Path Forward

Eisai will market the new drug as LEQEMBI, which will be commercially available in late January. Next challenge is to make LEQEMBI available to...

Tina Banerjee

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