Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

Ironwood Pharmaceuticals, Inc / Equity Bottom-Up

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<a href="https://www.smartkarma.com/entities/ironwood-pharmaceuticals-inc" target="_blank" data-smartkarma-citation="entities:15743:1" rel="noopener">Ironwood Pharmaceuticals, Inc (IRWD US)'s</a> sole marketed drug Linzess is the #1 prescribed branded treatment in the U.S. for adults with IBS-C/CIC with ~4M unique patients since launch.</li>
<li>First commercialized in December 2012, Linzess achieved blockbuster drug status in 2021. The earliest licensed entry of any generic Linzess in the U.S. is expected only in March 2029.</li>
<li>The company’s potential drug candidate IW-3300 is in phase 1 trial for interstitial cystitis/bladder pain syndrome (IC/BPS). Recently, Ironwood has shared positive findings from the study.  </li>
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Ironwood Pharmaceuticals, Inc (IRWD US)'s sole marketed drug Linzess is the #1 prescribed branded treatment in the U.S. for adults with IBS-C/CIC with ~4M unique patients since launch.
First commercialized in December 2012, Linzess achieved blockbuster drug status in 2021. The earliest licensed entry of any generic Linzess in the U.S. is expected only in March 2029.
The company’s potential drug candidate IW-3300 is in phase 1 trial for interstitial cystitis/bladder pain syndrome (IC/BPS). Recently, Ironwood has shared positive findings from the study.  


Ironwood Pharmaceuticals (IRWD US): Brand Leadership of Linzess Continues; Pipeline Advances

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<a href="https://www.smartkarma.com/entities/shanghai-junshi-bioscience-h" target="_blank" data-smartkarma-citation="entities:27760:1" rel="noopener">Shanghai Junshi Bioscience Co. Ltd. (1877 HK)'s</a> oncology drug candidate toripalimab marketing application is currently under priority review by the FDA, with a target action date of April 30, 2022.</li>
<li>However, FDA may reject toripalimab application, as it is predominantly based on China clinical trial data. Toripalimab may also face delay in FDA decision due to delayed regulatory inspection.</li>
<li>PD-1 drug market in the U.S. is intensely competitive, making the commercialization prospect of a new drug quite difficult. Toripalimab reported muted performance in China due to pricing headwind.</li>
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Shanghai Junshi Bioscience Co. Ltd. (1877 HK)'s oncology drug candidate toripalimab marketing application is currently under priority review by the FDA, with a target action date of April 30, 2022.
However, FDA may reject toripalimab application, as it is predominantly based on China clinical trial data. Toripalimab may also face delay in FDA decision due to delayed regulatory inspection.
PD-1 drug market in the U.S. is intensely competitive, making the commercialization prospect of a new drug quite difficult. Toripalimab reported muted performance in China due to pricing headwind.


Shanghai Junshi Bioscience (1877 HK): Uncertainties Prevailing Ahead of First U.S. Drug Approval

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<a href="https://www.smartkarma.com/entities/abbvie-inc" target="_blank" data-smartkarma-citation="entities:1135:1" rel="noopener">Abbvie Inc (ABBV US)</a> shares remained rangebound in 2021, mainly due to Humira patent expiration overhang. Humira is the flagship drug of the company, accounting for 37% of total revenue.</li>
<li>Increasing label expansion of its two other drugs, Skyrizi and Rinvoq are now increasingly opening up new growth avenues for AbbVie. Together these drugs contributed 8% to total revenue.</li>
<li>Attractive valuation and healthy dividend yield make AbbVie a top value investment idea amid this turbulent time.</li>
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Abbvie Inc (ABBV US) shares remained rangebound in 2021, mainly due to Humira patent expiration overhang. Humira is the flagship drug of the company, accounting for 37% of total revenue.
Increasing label expansion of its two other drugs, Skyrizi and Rinvoq are now increasingly opening up new growth avenues for AbbVie. Together these drugs contributed 8% to total revenue.
Attractive valuation and healthy dividend yield make AbbVie a top value investment idea amid this turbulent time.


AbbVie Inc (ABBV US): Great Value Stock to Buy in Choppy Market

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<a href="https://www.smartkarma.com/entities/sk-bioscience-co-ltd" target="_blank" data-smartkarma-citation="entities:31484:1" rel="noopener">SK Bioscience (302440 KS)</a> markets four in-house products in Korea, including influenza, shingles, and chicken pox vaccines. The company has partnerships with global companies for the production of COVID-19 vaccines. </li>
<li>SK Bioscience has started shipment of Novavax’ COVID-19 vaccine, while its own vaccine is in phase 3 trial. With ~15% vaccination in low-income countries, demand for vaccine is still high.  </li>
<li>SK Bioscience has a rich pipeline, with four promising blockbuster candidates for the global market. This entails strong revenue visibility in post-COVID era.</li>
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SK Bioscience (302440 KS) markets four in-house products in Korea, including influenza, shingles, and chicken pox vaccines. The company has partnerships with global companies for the production of COVID-19 vaccines. 
SK Bioscience has started shipment of Novavax’ COVID-19 vaccine, while its own vaccine is in phase 3 trial. With ~15% vaccination in low-income countries, demand for vaccine is still high.  
SK Bioscience has a rich pipeline, with four promising blockbuster candidates for the global market. This entails strong revenue visibility in post-COVID era.


SK Bioscience (302440 KS): An Attractive Pure-Play on Vaccines- Both COVID and Non-COVID

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<a href="https://www.smartkarma.com/entities/mesoblast-ltd" target="_blank" data-smartkarma-citation="entities:769:1" rel="noopener">Mesoblast Ltd (MSB AU)</a> has developed a range of late-stage product candidates derived from its first and second generation proprietary mesenchymal lineage cell therapy technology platforms.</li>
<li>BLA resubmission of remestemcel-L and formal BLA submission of rexlemestrocel-L to the FDA are two near-term catalysts for Mesoblast. Latest clinical trial results should support efficacy of both the candidates.</li>
<li>In November, Mesoblast completed a refinancing of its senior secured debt facility with a new $90 million five-year facility. Current funding is available for an estimated seven quarters.</li>
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Mesoblast Ltd (MSB AU) has developed a range of late-stage product candidates derived from its first and second generation proprietary mesenchymal lineage cell therapy technology platforms.
BLA resubmission of remestemcel-L and formal BLA submission of rexlemestrocel-L to the FDA are two near-term catalysts for Mesoblast. Latest clinical trial results should support efficacy of both the candidates.
In November, Mesoblast completed a refinancing of its senior secured debt facility with a new $90 million five-year facility. Current funding is available for an estimated seven quarters.


Mesoblast (MSB AU): Preparing for Re-Submission of Biologics License Application for Ryoncil

United Kingdom

AstraZeneca is a multinational pharmaceutical and biotechnology company that researches, develops, and manufactures prescription medicines. The company focuses on core therapeutic areas including oncology, cardiovascular, renal and metabolic diseases, respiratory and immunology, and rare diseases. It was founded in 1999 and is headquartered in Cambridge, UK.

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AstraZeneca (AZNN MM)

Ironwood Pharmaceuticals (IRWD US): Brand Leadership of Linzess Continues; Pipeline Advances

Ironwood’s flagship drug Linzess achieved blockbuster status in 2021 and is still growing by low single digit. Two pipeline GI drug candidates...

Tina Banerjee

Shanghai Junshi Bioscience (1877 HK): Uncertainties Prevailing Ahead of First U.S. Drug Approval

Going by the FDA’s recent action, Junshi Bioscience’s toripalimab has a chance to get rejected by the FDA. It may miss the approval timeline....

Tina Banerjee

AbbVie Inc (ABBV US): Great Value Stock to Buy in Choppy Market

Abbvie’s reducing dependence on Humira, visibility on non-Humira portfolio, coupled with high dividend yield and attractive valuation make it a top...

Tina Banerjee

SK Bioscience (302440 KS): An Attractive Pure-Play on Vaccines- Both COVID and Non-COVID

SK Bioscience’s near-term growth will be driven by CMO contract of Novavax COVID-19 vaccine. The company’s rich non-COVID pipeline and global...

Tina Banerjee

Mesoblast (MSB AU): Preparing for Re-Submission of Biologics License Application for Ryoncil

Mesoblast is preparing for biologics license application for two of its pipeline candidates. The company believes it has generated substantial new...

Tina Banerjee

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