India Equity Analyst - Fundamental & Thematic, Beat the Street

Sudarshan Bhandari

India Equity Analyst - Fundamental & Thematic

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Thematic (Sector/Industry)

<ul>
<li>MFN policy aims to align US drug prices with the lowest prices paid by other developed nations, potentially resulting in significant price reductions.</li>
<li>Indian pharma players have limited impact, considering only few companies have notable presence in branded markets</li>
<li>Repercussions for pharma are wider in terms of potential lower R&amp;D spend along with squeezed margins. Though implementation of policy key moniterable</li>
</ul>


MFN policy aims to align US drug prices with the lowest prices paid by other developed nations, potentially resulting in significant price reductions.
Indian pharma players have limited impact, considering only few companies have notable presence in branded markets
Repercussions for pharma are wider in terms of potential lower R&amp;D spend along with squeezed margins. Though implementation of policy key moniterable


Thematic Report: Will the US MFN Policy for Pharma Impact Indian Pharmaceuticals?

External broker reports(aggregated public sources), HDFC Securities

HDFC Securities

External broker reports(aggregated public sources)

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<ul><li>The US president Donald Trump signed an “Executive Order” (EO) to bring the prices for prescription (Rx) drugs in line with other developed nations</li><li>The EO institutes the “Most-Favoured-Nation (MFN)” price model (international reference pricing for prescription drugs) for drugs as a ceiling which means the US will pay for drugs at same levels as the lowest paid by other countries</li><li>This time MFN model has expanded its coverage for both Medicare and Medicaid (earlier in 2020, it was only for Medicare)</li></ul><p><em>Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.</em></p>

The US president Donald Trump signed an “Executive Order” (EO) to bring the prices for prescription (Rx) drugs in line with other developed nationsThe EO institutes the “Most-Favoured-Nation (MFN)” price model (international reference pricing for prescription drugs) for drugs as a ceiling which means the US will pay for drugs at same levels as the lowest paid by other countriesThis time MFN model has expanded its coverage for both Medicare and Medicaid (earlier in 2020, it was only for Medicare)Content is external broker report sourced from online content aggregator through publicly available sources and is displayed below for general informational purposes only. Refer full disclaimer below.

Pharmaceuticals: US to cut Rx drug price, no impact on generics

Global Healthcare Analyst

Tina Banerjee

<ul>
<li>EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.</li>
<li>Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.</li>
<li>The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.</li>
</ul>


EMA’s human medicines committee (CHMP) recommended sixteen medicines for approval at its April 2025 meeting. CHMP also adopted positive opinion for nine biosimilar medicines.
Among the new medicines, Vertex’s triple combination cystic fibrosis drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s billiary tract cancer drug Ziihera have potential to become blockbusters.
The Agency has recommended the refusal of the marketing authorization for Eli Lilly’s Alzheimer’s Disease drug Kisunla. Eli Lilly may ask for a re-examination of the opinion within 15 days.


CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

<ul>
<li>FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.</li>
<li>Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.</li>
<li>Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.</li>
</ul>


FDA has confirmed the primary endpoints for Neuren Pharmaceuticals’ planned Phase 3 pivotal clinical trial of NNZ-2591 in Phelan-McDermid syndrome. Eisai has ultimately received its long-waited European approval for Leqembi.
Chugai Pharmaceutical’s outlicensed oral GLP-1 drug candidate orforglipron has shown positive topline Phase 3 results. Telix announced preliminary results from the Phase 2 study of TLX101 in recurrent high-grade glioma.
Biocon secured market entry date for Yesafili, an interchangeable biosimilar to Eylea in the U.S. FDA has issued Form 483 with 11 observations for Aurobindo Pharma’s North Carolina inhaler plant.


APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

<ul>
<li>The U.S. has started collecting baseline tariff of 10% from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable to possible tariff threat.</li>
<li>During 9MFY25, the U.S. has been the top exporting destination for Indian pharmaceutical products, with 33% share in the exports.</li>
<li>With negotiations on, India might opt for “zero for zero” tariff approach specifically in the case of Pharmaceutical and Medical devices.</li>
</ul>


The U.S. has started collecting baseline tariff of 10% from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable to possible tariff threat.
During 9MFY25, the U.S. has been the top exporting destination for Indian pharmaceutical products, with 33% share in the exports.
With negotiations on, India might opt for “zero for zero” tariff approach specifically in the case of Pharmaceutical and Medical devices.


US Tariff Impact on APAC Healthcare: Focus Country- INDIA

India

Aurobindo Pharma is an Indian multinational pharmaceutical manufacturing company that develops, manufactures, and commercializes a wide range of generic pharmaceuticals, active pharmaceutical ingredients (APIs), and specialty formulations. The company's product portfolio covers therapeutic areas including antibiotics, anti-retrovirals, cardiovascular, central nervous system, gastroenterologicals, anti-allergics, oncology, and dermatology. It commenced operations in 1988-1989 with a single unit manufacturing semi-synthetic penicillin in Puducherry. Headquartered in Hyderabad, Telangana, India, the company was founded in 1986.

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Aurobindo Pharma (ARBP IN)

Thematic Report: Will the US MFN Policy for Pharma Impact Indian Pharmaceuticals?

US MFN drug pricing policy aims to lower prices by aligning with other developed nations, impacting pharma R&D spend and margins, with limited...

Sudarshan Bhandari

Pharmaceuticals: US to cut Rx drug price, no impact on generics

The US president Donald Trump signed an “Executive Order” (EO) to bring the prices for prescription (Rx) drugs in line with other developed nations

HDFC Securities

CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

Among the new medicines, Vertex’s triple combination CF drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s cancer...

Tina Banerjee

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

US Tariff Impact on APAC Healthcare: Focus Country- INDIA

US imposed baseline tariff from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable. U.S. has been...

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

Thematic Report: Will the US MFN Policy for Pharma Impact Indian Pharmaceuticals?

​US MFN drug pricing policy aims to lower prices by aligning with other developed nations, impacting pharma R&D spend and margins, with limited...

Sudarshan Bhandari

Pharmaceuticals: US to cut Rx drug price, no impact on generics

The US president Donald Trump signed an “Executive Order” (EO) to bring the prices for prescription (Rx) drugs in line with other developed nations

HDFC Securities

CHMP Meeting Update April 2025: Sixteen New Medicines Recommended For Approval

Among the new medicines, Vertex’s triple combination CF drug Alyftrek, Amgen’s Thyroid eye disease drug Tepezza, and Jazz Pharmaceutical’s cancer...

Tina Banerjee

APAC Healthcare Weekly (April 20)- Neuren, Chugai, Eisai, Telix, Biocon, Aurobindo Pharma

Neuren is a step closer to P3 trial in PMS. Chugai’s oral GLP-1 drug candidate shows promise in P3 trial. Eisai got Leqembi approval in EU. Biocon...

Tina Banerjee

US Tariff Impact on APAC Healthcare: Focus Country- INDIA

US imposed baseline tariff from April 5. Reciprocal tariff has been temporarily halted but Indian Pharma companies remain vulnerable. U.S. has been...

Tina Banerjee

US MFN drug pricing policy aims to lower prices by aligning with other developed nations, impacting pharma R&D spend and margins, with limited...