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Baxter International Inc. (BAX - Free Report) recently received the FDA’s approval for an expanded indication for Clinolipid (Lipid Injectable Emulsion) to be used in pediatric patients, including preterm and term neonates. Clinolipid, which provides calories and essential fatty acids for parenteral nutrition, is currently available to order in the United States.
Clinolipid has been available in the United States for adults since 2019 and is now available for use in all ages.
The latest regulatory clearance is expected to significantly boost Baxter’s Infusion Therapies and Technologies product line under the broader Medical Products and Therapies segment and solidify its foothold in the nutrition therapy space.
Significance of the Approval
Parenteral nutrition plays a crucial role in helping treat and reduce the risk of malnutrition. Per Baxter’s estimates, about 40% of patients in the United States who receive parenteral (intravenous) nutrition (PN) as an intravenous source of nourishment are under the age of 18. Intravenous lipid emulsions are used to provide calories and essential fatty acids for patients who cannot intake a sufficient source of nutrition orally or enterally.
Clinolipid is Baxter’s proprietary mixed oil lipid emulsion that is used to provide calories and essential fatty acids in PN when oral or enteral nutrition is not possible, insufficient or contraindicated.
Per management, expanding access to Clinolipid for the critical and vulnerable patient population will likely offer clinicians versatility in choosing the product that best suits their patients’ needs.
Industry Prospects
Per a report by Precedence Research, the global clinical nutrition market was estimated at $38 billion in 2023 and is anticipated to exceed $70.33 billion by 2032 at a CAGR of 6.4%. Factors like the rise in the incidence of chronic diseases, the increasing number of patients using sophisticated clinical nutritional products and the growing concern about malnutrition in pediatric patients are expected to drive the market.
Given the market potential, the FDA’s latest expanded indication is expected to significantly boost Baxter’s business.
Recent Developments
This month, Baxter reported its first-quarter 2024 results, wherein its Medical Products & Therapies segment delivered mid-single-digit growth at constant currency rates, reflecting the benefit of positive demand and pricing across the segment.
Last month, Baxter received the FDA’s 510(k) clearance for its Novum IQ large-volume infusion pump with Dose IQ Safety Software.
Price Performance
Shares of Baxter have lost 17.3% in the past year compared with the industry’s 3.5% decline. The S&P 500 has witnessed 26.5% growth in the said time frame.
DaVita, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 41.5% compared with the industry’s 23.7% rise in the past year.
Veeva Systems, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 24.1%. VEEV’s earnings surpassed estimates in each of the trailing four quarters, with the average being 8.5%.
Veeva Systems has gained 16% compared with the industry’s 47.7% rise in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.5%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.3%.
Ecolab’s shares have rallied 33.7% against the industry’s 10.2% decline in the past year.
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Baxter's (BAX) Clinolipid Gets FDA's Expanded Indication
Baxter International Inc. (BAX - Free Report) recently received the FDA’s approval for an expanded indication for Clinolipid (Lipid Injectable Emulsion) to be used in pediatric patients, including preterm and term neonates. Clinolipid, which provides calories and essential fatty acids for parenteral nutrition, is currently available to order in the United States.
Clinolipid has been available in the United States for adults since 2019 and is now available for use in all ages.
The latest regulatory clearance is expected to significantly boost Baxter’s Infusion Therapies and Technologies product line under the broader Medical Products and Therapies segment and solidify its foothold in the nutrition therapy space.
Significance of the Approval
Parenteral nutrition plays a crucial role in helping treat and reduce the risk of malnutrition. Per Baxter’s estimates, about 40% of patients in the United States who receive parenteral (intravenous) nutrition (PN) as an intravenous source of nourishment are under the age of 18. Intravenous lipid emulsions are used to provide calories and essential fatty acids for patients who cannot intake a sufficient source of nutrition orally or enterally.
Clinolipid is Baxter’s proprietary mixed oil lipid emulsion that is used to provide calories and essential fatty acids in PN when oral or enteral nutrition is not possible, insufficient or contraindicated.
Per management, expanding access to Clinolipid for the critical and vulnerable patient population will likely offer clinicians versatility in choosing the product that best suits their patients’ needs.
Industry Prospects
Per a report by Precedence Research, the global clinical nutrition market was estimated at $38 billion in 2023 and is anticipated to exceed $70.33 billion by 2032 at a CAGR of 6.4%. Factors like the rise in the incidence of chronic diseases, the increasing number of patients using sophisticated clinical nutritional products and the growing concern about malnutrition in pediatric patients are expected to drive the market.
Given the market potential, the FDA’s latest expanded indication is expected to significantly boost Baxter’s business.
Recent Developments
This month, Baxter reported its first-quarter 2024 results, wherein its Medical Products & Therapies segment delivered mid-single-digit growth at constant currency rates, reflecting the benefit of positive demand and pricing across the segment.
Last month, Baxter received the FDA’s 510(k) clearance for its Novum IQ large-volume infusion pump with Dose IQ Safety Software.
Price Performance
Shares of Baxter have lost 17.3% in the past year compared with the industry’s 3.5% decline. The S&P 500 has witnessed 26.5% growth in the said time frame.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Baxter carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Veeva Systems Inc. (VEEV - Free Report) and Ecolab Inc. (ECL - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 13.6%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 29.4%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 41.5% compared with the industry’s 23.7% rise in the past year.
Veeva Systems, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 24.1%. VEEV’s earnings surpassed estimates in each of the trailing four quarters, with the average being 8.5%.
Veeva Systems has gained 16% compared with the industry’s 47.7% rise in the past year.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.5%. ECL’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 1.3%.
Ecolab’s shares have rallied 33.7% against the industry’s 10.2% decline in the past year.