Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/argenx-se" target="_blank" data-smartkarma-citation="entities:28604:1" rel="noopener">Argenx SE (ARGX US)</a> won FDA approval for second indication of Vyvgart for chronic inflammatory demyelinating polyneuropathy (CIDP) in June. The approval triggered ~30% rally in the share price.</li>
<li>
<a href="https://www.smartkarma.com/entities/johnson-johnson" target="_blank" data-smartkarma-citation="entities:1132:1" rel="noopener">Johnson &amp; Johnson (JNJ US)</a> is seeking FDA approval for nipocalimab for generalized myasthenia gravis (gMG). Approved in 2021, Vyvgart dominates the gMG market. In 1H24, Vyvgart fetched $876M revenue.</li>
<li>Nipocalimab will compete with Vyvgart. However, Argenx has already created a niche for itself and will continue to sit on a prime position due to its first mover advantage.</li>
</ul>



Argenx SE (ARGX US) won FDA approval for second indication of Vyvgart for chronic inflammatory demyelinating polyneuropathy (CIDP) in June. The approval triggered ~30% rally in the share price.

Johnson &amp; Johnson (JNJ US) is seeking FDA approval for nipocalimab for generalized myasthenia gravis (gMG). Approved in 2021, Vyvgart dominates the gMG market. In 1H24, Vyvgart fetched $876M revenue.
Nipocalimab will compete with Vyvgart. However, Argenx has already created a niche for itself and will continue to sit on a prime position due to its first mover advantage.


Argenx SE (ARGX US): Vyvgart Indication Expansion Triggers Rally; Can Competition Play Spoilsport?

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

Thematic (Sector/Industry)

<ul><li>Large pharma’s bounce from the mostly ineffective Most- Favored-Nation (MFN) executive order was short-lived, as new CMS draft guidance for Medicare price negotiations threatened certain drug combos.</li><li>President Trump’s MFN executive order lacked a clear plan to lower drug prices, with any immediate moves likely facing legal challenges.</li><li>Listen to the WTR Biotech Flashcast for our MFN take.</li></ul>

Large pharma’s bounce from the mostly ineffective Most- Favored-Nation (MFN) executive order was short-lived, as new CMS draft guidance for Medicare price negotiations threatened certain drug combos.President Trump’s MFN executive order lacked a clear plan to lower drug prices, with any immediate moves likely facing legal challenges.Listen to the WTR Biotech Flashcast for our MFN take.

Biopharma Week in Review MFN Fears Overdone but Medicare Negotiation Changes Reapplied Pressure

<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>We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.</li>
<li>Last week, BMY received landmark antipsychotic approval, while BHVN finally scored a win in rare genetic SCA.</li>
<li>AMGN had approvable data in atopic dermatitis and gMG, but not enough to dethrone REGN and ARGX. </li>
</ul>


We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&amp;A.
Last week, BMY received landmark antipsychotic approval, while BHVN finally scored a win in rare genetic SCA.
AMGN had approvable data in atopic dermatitis and gMG, but not enough to dethrone REGN and ARGX. 


Biopharma Week in Review - September 30, 2024

<ul>
<li>
<a href="https://www.smartkarma.com/entities/zai-lab-ltd-94df40cf-c15e-462f-b3de-8d2d434ae935" target="_blank" data-smartkarma-citation="entities:36261:1" rel="noopener">Zai Lab (9688 HK)</a> recorded Vyvgart revenue of $10M, $13M, and $23M in 4Q23, 1Q24, and 2Q24, respectively. The company raised 2024 Vyvgart revenue guidance to $80M from $70M earlier.</li>
<li>Despite strong momentum from Vyvgart, Zai Lab still has a lot of pain points. Decelerating revenue growth from Zejula is one of them.</li>
<li>Due to its in-licensing business model, Zai Lab has lower gross profit margin of 64–65%, compared with ~80% for a typical innovator biotech company.</li>
</ul>



Zai Lab (9688 HK) recorded Vyvgart revenue of $10M, $13M, and $23M in 4Q23, 1Q24, and 2Q24, respectively. The company raised 2024 Vyvgart revenue guidance to $80M from $70M earlier.
Despite strong momentum from Vyvgart, Zai Lab still has a lot of pain points. Decelerating revenue growth from Zejula is one of them.
Due to its in-licensing business model, Zai Lab has lower gross profit margin of 64–65%, compared with ~80% for a typical innovator biotech company.


Zai Lab (9688 HK): Vyvgart Is Not the De-Risking Tool; Future Is Still Uncertain

Netherlands

argenx SE operates as a biotechnology company. The Company develops antibody based therapies for the treatment of severe autoimmune diseases and cancer. argenx serves customers in the Netherlands and Belgium.

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Argenx SE (ARGX US)

Argenx SE (ARGX US): Vyvgart Indication Expansion Triggers Rally; Can Competition Play Spoilsport?

Argenx won FDA approval for second indication of Vyvgart for CIDP in June. Currently, Vyvgart dominates gMG treatment market. Competitor's drug...

Tina Banerjee

Biopharma Week in Review MFN Fears Overdone but Medicare Negotiation Changes Reapplied Pressure

President Trump’s MFN executive order lacked a clear plan to lower drug prices, with any immediate moves likely facing legal challenges.

Water Tower Research

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

Biopharma Week in Review - September 30, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Last week, BMY received...

Water Tower Research

Zai Lab (9688 HK): Vyvgart Is Not the De-Risking Tool; Future Is Still Uncertain

Zai Lab's Vyvgart revenue sees significant growth, but challenges remain with decelerating Zejula revenue and lower gross profit margins due to in...

Tina Banerjee

Price Gauge

52-week Range

Market Cap (USDm)

P/E

Dividend (Yield)

Argenx SE (ARGX US): Vyvgart Indication Expansion Triggers Rally; Can Competition Play Spoilsport?

Argenx won FDA approval for second indication of Vyvgart for CIDP in June. Currently, Vyvgart dominates gMG treatment market. Competitor's drug...

Tina Banerjee

Biopharma Week in Review MFN Fears Overdone but Medicare Negotiation Changes Reapplied Pressure

President Trump’s MFN executive order lacked a clear plan to lower drug prices, with any immediate moves likely facing legal challenges.

Water Tower Research

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

Biopharma Week in Review - September 30, 2024

We review last week’s biopharma news for meaningful clinical data, regulatory updates, research innovation, and M&A. Last week, BMY received...

Water Tower Research

Zai Lab (9688 HK): Vyvgart Is Not the De-Risking Tool; Future Is Still Uncertain

​Zai Lab's Vyvgart revenue sees significant growth, but challenges remain with decelerating Zejula revenue and lower gross profit margins due to in...

Tina Banerjee

Zai Lab's Vyvgart revenue sees significant growth, but challenges remain with decelerating Zejula revenue and lower gross profit margins due to in...