Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.</li>
<li>The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.</li>
<li>Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.</li>
</ul>


In its January 2025 meeting, EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including four innovative, three biosimilars, and one generic drugs.
The committee has also recommended extensions of indication for eight medicines that are already authorized in the EU.
Marketing applications for two medicines were withdrawn. Among them, withdrawal of Daiichi Sankyo’s datopotamab deruxtecan for non-squamous non-small cell lung cancer is noteworthy.


CHMP Meeting Update: Eight New Medicines Recommended For Approval

<ul>
<li>Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.</li>
<li>Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.</li>
<li>Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.</li>
</ul>


Daiichi Sankyo received seventh FDA approval for Enhertu in certain types of breast cancers. Eisai received FDA approval for Leqembi’s intravenous monthly maintenance dosing.
Nippon Shinyaku entered into an option agreement with AB2 BIO for the rights of commercialization of Tadekinig alfa in the U.S. for certain rare autoinflammatory diseases.
Shionogi announced positive results from Phase 2 trial of its novel investigational RSV oral antiviral candidate S-337395. Celltrion has received FDA approval for Actemra biosimilar.


APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/ono-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:8979:1" rel="noopener">Ono Pharmaceutical (4528 JP)</a> is reporting decelerating revenue from its flagship drug, Opdivo. During H1FY25, domestic revenue from Opdivo decreased 17% YoY to ¥62.6B.</li>
<li>Opdivo will start to lose patent protection starting from 2028. Prolific commercialization of these new drugs will remain crucial for Ono riding the patent cliff successfully.</li>
<li>Ono shares plunged 36% over the last one year to trade at attractive valuation. In absence of any near-term growth catalyst, the shares are not expected to see much upside.</li>
</ul>



Ono Pharmaceutical (4528 JP) is reporting decelerating revenue from its flagship drug, Opdivo. During H1FY25, domestic revenue from Opdivo decreased 17% YoY to ¥62.6B.
Opdivo will start to lose patent protection starting from 2028. Prolific commercialization of these new drugs will remain crucial for Ono riding the patent cliff successfully.
Ono shares plunged 36% over the last one year to trade at attractive valuation. In absence of any near-term growth catalyst, the shares are not expected to see much upside.


Ono Pharmaceutical (4528 JP): Struggle Continues with Opdivo; Competition and Price Cuts Loom Large

Independent research on the U.S. markets, Baptista Research

Baptista Research

Independent research on the U.S. markets

Baptista Research is an independent financial research house focused on the U.S. markets. We provide equity research as well as credit research reports on the top-listed U.S. companies with most of our focus on technology, consumer goods and services, automobiles, industrials, oil and gas, pharma, and healthcare. Our research has served more than 3000 institutional investors including mutual funds, hedge funds, banks, family offices, and various buy-side firms. We operate a research subscription service where institutions, as well as retail investors, can have priority access to all our research. We also have a wide distribution of our research reports across some of the top global financial platforms. Apart from equity research and credit research, we also provide advisory services with respect to mergers & acquisitions (M&A), private equity/ venture capital fundraising, valuation reports, and investment management services for corporates.
Baptista Research is owned and managed by Ishan Majumdar, an ex-Venture Capitalist/ Investment Banker, a Chartered Accountant, and a Masters’ degree holder in Management from HEC Paris. Ishan has nearly a decade of experience in Mergers and Acquisitions, Leveraged Buyouts (LBOs), Venture Capital Investing, Corporate Strategy, and Valuation in front-office roles at the likes of BNP Paribas CIB, Credit Agricole CIB, Groupe Danone, and TIW Private Equity. He has worked on and closed multiple acquisition deals, leveraged buyouts, and start-up investment transactions.

Bristol Myers Squibb Co / Equity Bottom-Up

<ul><li>Bristol-Myers Squibb's third quarter 2024 earnings highlight a period of robust growth and strategic advancements, albeit accompanied by challenges typical of large pharmaceutical companies.</li><li>On the positive side, the company reported a noteworthy 20% revenue increase in its growth portfolio at constant currency, which now contributes to approximately half of the total revenues.</li><li>This growth is supported by products with exclusivity extending into the next decade, underscoring the company’s successful pipeline development and launch of new therapies.</li></ul>

Bristol-Myers Squibb's third quarter 2024 earnings highlight a period of robust growth and strategic advancements, albeit accompanied by challenges typical of large pharmaceutical companies.On the positive side, the company reported a noteworthy 20% revenue increase in its growth portfolio at constant currency, which now contributes to approximately half of the total revenues.This growth is supported by products with exclusivity extending into the next decade, underscoring the company’s successful pipeline development and launch of new therapies.

Bristol-Myers Squibb: Expansion into Alzheimer's Disease Psychosis Treatment As A Key Growth Catalyst! - Major Drivers

Research from Water Tower Research, Water Tower Research

Water Tower Research

Research from Water Tower Research

Water Tower Research is a leading equity research firm that provides research on micro, small and mid cap companies.

Water Tower Research was founded by Wall Street veterans after witnessing a fundamental shift in the investment research industry with the result being a declining knowledge base among investors, a lack of awareness and a shrinking pool of fundamental research being conducted on companies across the small-cap and micro-cap spectrum. The same issues are now increasingly occurring in the mid-cap space. This sea change within the investment community is impacting not only the companies themselves but also current shareholders and potential investors. With significantly less active sell-side sponsorship by Wall Street, a substantial information gap has developed between companies and various constituents in the financial community. The net result is fewer channels for insight and information to flow between companies and investors.

Equity Research Firm

<ul><li>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li><li>Last week, Trump named RFK Jr. to lead the HHS, placing an overhang on XBI and vaccine makers PFE, GSK, MRNA, MRK, and SNY. BNTX and MRK made moves in the PD- 1/VEGF space.</li><li>ABBV’s costly neuro play failed, removing the main threat to BMY’s Cobenfy. AMGN was rattled by bone loss data for its obesity drug. </li></ul>

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.Last week, Trump named RFK Jr. to lead the HHS, placing an overhang on XBI and vaccine makers PFE, GSK, MRNA, MRK, and SNY. BNTX and MRK made moves in the PD- 1/VEGF space.ABBV’s costly neuro play failed, removing the main threat to BMY’s Cobenfy. AMGN was rattled by bone loss data for its obesity drug. 

Biopharma Week in Review - November 18, 2024

United States

Bristol-Myers Squibb Company is a global biopharmaceutical company. The Company develops, licenses, manufactures, markets, and sells pharmaceutical and nutritional products. Bristol Myers Squibb focuses on products and experimental therapies address cancer, heart disease, HIV and AIDS, diabetes, rheumatoid arthritis, hepatitis, organ transplant rejection, and psychiatric disorders.

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Bristol-Myers Squibb (BMY UN)

CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

Ono Pharmaceutical (4528 JP): Struggle Continues with Opdivo; Competition and Price Cuts Loom Large

Ono Pharmaceutical's revenue from Opdivo is slowing down. The company will face patent cliff in 2028. Shares are down 36% in past year, with...

Tina Banerjee

Bristol-Myers Squibb: Expansion into Alzheimer's Disease Psychosis Treatment As A Key Growth Catalyst! - Major Drivers

Bristol-Myers Squibb's third quarter 2024 earnings highlight a period of robust growth and strategic advancements, albeit accompanied by...

Baptista Research

Biopharma Week in Review - November 18, 2024

ABBV’s costly neuro play failed, removing the main threat to BMY’s Cobenfy. AMGN was rattled by bone loss data for its obesity drug.

Water Tower Research

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CHMP Meeting Update: Eight New Medicines Recommended For Approval

In its January 2025 meeting, CHMP recommended 8 drugs for approval, including 4 innovative, 3 biosimilars, and 1 generic drugs. The committee has...

Tina Banerjee

APAC Healthcare Weekly (Feb 2)- Daiichi Sankyo, Eisai, Nippon Shinyaku, Shionogi, Celltrion

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

Ono Pharmaceutical (4528 JP): Struggle Continues with Opdivo; Competition and Price Cuts Loom Large

​Ono Pharmaceutical's revenue from Opdivo is slowing down. The company will face patent cliff in 2028. Shares are down 36% in past year, with...

Tina Banerjee

Bristol-Myers Squibb: Expansion into Alzheimer's Disease Psychosis Treatment As A Key Growth Catalyst! - Major Drivers

Bristol-Myers Squibb's third quarter 2024 earnings highlight a period of robust growth and strategic advancements, albeit accompanied by...

Baptista Research

Biopharma Week in Review - November 18, 2024

ABBV’s costly neuro play failed, removing the main threat to BMY’s Cobenfy. AMGN was rattled by bone loss data for its obesity drug.

Water Tower Research

Ono Pharmaceutical's revenue from Opdivo is slowing down. The company will face patent cliff in 2028. Shares are down 36% in past year, with...