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?

Technical Analyst, Vermilion Research

Joe Jasper

Technical Analyst

Technical and Quantitative Research

Vermilion Research

Vermilion’s objective is to deliver timely, actionable, and unique technical research to professional investors through the application of our various technical indicators.

Our research strategists seek to highlight securities which we believe are at major inflection points, based on our various technical and quantitative indicators, and offer asymmetric risk/return profiles. Our unique research methodology, centered on relative strength, enables our strategists to deliver superior investment recommendations.

Our process begins by organizing the universe of actively traded stocks into discrete sectors, then into industry groups. We then apply our technical and quantitative tools to identify developing price trends. Once attractive trends are identified within a selected sector or group, we screen for individual stocks which we believe offer the best risk/reward profile. We provide a historical perspective that often reveals, through our long-term charts, how price patterns often repeat themselves over time.

Technical Analysis

<ul>
<li>Snap-Back rallies have continued in the largest global equity markets (U.S., Japan, and Europe).</li>
<li>Japan's TOPIX is still below 2690-2700 and the EURO STOXX 50 is below 4884, and whether they roll over here or from marginally higher levels, lower highs remain likely.</li>
<li>It all fits with our ongoing belief (since our July 25, 2024 Int'l Compass) that MSCI ACWI is going through a 1- to 4-month pullback/consolidation (we are one month in).</li>
</ul>


Snap-Back rallies have continued in the largest global equity markets (U.S., Japan, and Europe).
Japan's TOPIX is still below 2690-2700 and the EURO STOXX 50 is below 4884, and whether they roll over here or from marginally higher levels, lower highs remain likely.
It all fits with our ongoing belief (since our July 25, 2024 Int'l Compass) that MSCI ACWI is going through a 1- to 4-month pullback/consolidation (we are one month in).


Shift Now to Defensives; Snap-Back Rally Testing Resistance $ACWI $SPX; Neutral Outlook Intact

<ul>
<li>We believe a 1-4-month pullback/consolidation is ongoing, and we would look for an important low to be made near the U.S. election.</li>
<li>Supports to watch continue to be $110 on $ACWI and $41-42 on MSCI EM $EEM, and whether these levels hold or not will determine the severity of the pullback.</li>
<li>Primary reasons for this bearish expectation include major bullish RS inflections for defensive Sectors, and bearish price action in the U.S. (SPX), Japan (TOPIX/Nikkei 225), and Europe (EURO STOXX 50)</li>
</ul>


We believe a 1-4-month pullback/consolidation is ongoing, and we would look for an important low to be made near the U.S. election.
Supports to watch continue to be $110 on $ACWI and $41-42 on MSCI EM $EEM, and whether these levels hold or not will determine the severity of the pullback.
Primary reasons for this bearish expectation include major bullish RS inflections for defensive Sectors, and bearish price action in the U.S. (SPX), Japan (TOPIX/Nikkei 225), and Europe (EURO STOXX 50)


Pullback Continues $ACWI; Stick With Defensives; More Countries With Improving Price and RS Trends

<ul>
<li>
<a href="https://www.smartkarma.com/entities/samsung-biologics-co-ltd" target="_blank" data-smartkarma-citation="entities:22932:1" rel="noopener">Samsung Biologics (207940 KS)</a> has signed the largest ever single CMO contract worth KRW1.46T ($1.1B) with an undisclosed U.S.-based pharmaceutical company. The contract value represents ~40% of 2023 standalone revenue.</li>
<li>Within the first half of the year, Samsung Biologics has secured order worth of KRW2.6T, compared with order win of KRW3.5T in full-year 2023.</li>
<li>Samsung Bioepis has received FDA approval for Stelara biosimilar Pyzchiva, which is expected to marketed in early 2025. So far, the FDA has approved two other biosimilars of Stelara.  </li>
</ul>



Samsung Biologics (207940 KS) has signed the largest ever single CMO contract worth KRW1.46T ($1.1B) with an undisclosed U.S.-based pharmaceutical company. The contract value represents ~40% of 2023 standalone revenue.
Within the first half of the year, Samsung Biologics has secured order worth of KRW2.6T, compared with order win of KRW3.5T in full-year 2023.
Samsung Bioepis has received FDA approval for Stelara biosimilar Pyzchiva, which is expected to marketed in early 2025. So far, the FDA has approved two other biosimilars of Stelara.  


Samsung Biologics (207940 KS): Gaining Momentum on New Approval and Contract Wins; Hold Shares

SK Biopharmaceuticals   / Equity Bottom-Up

<ul>
<li>In 1Q24, <a href="https://www.smartkarma.com/entities/sk-biopharmaceuticals-co-ltd" target="_blank" data-smartkarma-citation="entities:28966:1" rel="noopener">SK Biopharmaceuticals (326030 KS)</a> posted Xcopri U.S. sales of KRW90.9B, up 69% YoY and 17% QoQ. The company remains confident to meet annual sales guidance of KRW390–416B.</li>
<li>1Q24 operating profit reached KRW10B from an operating loss of KRW23B in 1Q23. The company aims to achieve profitability throughout 2024.</li>
<li>The company is seeking a second product to strengthen its U.S. and global business. Xcopri also has potential for indication expansion in near future.</li>
</ul>


In 1Q24, SK Biopharmaceuticals (326030 KS) posted Xcopri U.S. sales of KRW90.9B, up 69% YoY and 17% QoQ. The company remains confident to meet annual sales guidance of KRW390–416B.
1Q24 operating profit reached KRW10B from an operating loss of KRW23B in 1Q23. The company aims to achieve profitability throughout 2024.
The company is seeking a second product to strengthen its U.S. and global business. Xcopri also has potential for indication expansion in near future.


SK Biopharmaceuticals (326030 KS): Resumption of US Sales Growth Raises Hope for Annual Profit

Belgium

UCB SA is a biopharmaceutical company. The Company specializes in the treatment of central nervous system disorders and inflammatory diseases. UCB operates worldwide.

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UCB SA (UCB BB)

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

Shift Now to Defensives; Snap-Back Rally Testing Resistance $ACWI $SPX; Neutral Outlook Intact

Shift Now to Defensives (Health Care, Telecommunications, Utilities, and Consumer Staples); Snap-Back Rally Testing Resistance $ACWI $SPX; Neutral...

Vermilion Research

Pullback Continues $ACWI; Stick With Defensives; More Countries With Improving Price and RS Trends

Pullback Continues $ACWI; Stick With Defensives. We continue to believe a 1- to 4-month pullback/consolidation is ongoing, and would look for an...

Vermilion Research

Samsung Biologics (207940 KS): Gaining Momentum on New Approval and Contract Wins; Hold Shares

Samsung Biologics signs $1.1B CMO contract, representing 40% of 2023 revenue. Samsung Bioepis receives FDA approval for Stelara biosimilar...

Tina Banerjee

SK Biopharmaceuticals (326030 KS): Resumption of US Sales Growth Raises Hope for Annual Profit

In 1Q24, SK Biopharmaceuticals posted Xcopri U.S. sales of KRW90.9B, up 69% YoY and 17% QoQ. The company remains confident to meet Xcopri annual...

Tina Banerjee

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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

Shift Now to Defensives; Snap-Back Rally Testing Resistance $ACWI $SPX; Neutral Outlook Intact

Shift Now to Defensives (Health Care, Telecommunications, Utilities, and Consumer Staples); Snap-Back Rally Testing Resistance $ACWI $SPX; Neutral...

Vermilion Research

Pullback Continues $ACWI; Stick With Defensives; More Countries With Improving Price and RS Trends

Pullback Continues $ACWI; Stick With Defensives. We continue to believe a 1- to 4-month pullback/consolidation is ongoing, and would look for an...

Vermilion Research

Samsung Biologics (207940 KS): Gaining Momentum on New Approval and Contract Wins; Hold Shares

​Samsung Biologics signs $1.1B CMO contract, representing 40% of 2023 revenue. Samsung Bioepis receives FDA approval for Stelara biosimilar...

Tina Banerjee

SK Biopharmaceuticals (326030 KS): Resumption of US Sales Growth Raises Hope for Annual Profit

In 1Q24, SK Biopharmaceuticals posted Xcopri U.S. sales of KRW90.9B, up 69% YoY and 17% QoQ. The company remains confident to meet Xcopri annual...

Tina Banerjee

Samsung Biologics signs $1.1B CMO contract, representing 40% of 2023 revenue. Samsung Bioepis receives FDA approval for Stelara biosimilar...