07.22.21
Rank: #10 (Last year: #10)
$11.67 Billion
Prior Fiscal: $11.40 billion
Percentage Change: +3%
No. of Employees: 50,000
Global Headquarters: Deerfield, Ill.
KEY EXECUTIVES:
José (Joe) E. Almeida, Chairman, President, and CEO
Giuseppe Accogli, SVP and President, Americas and Global Business Units
Laura Angelini, GM, Renal Care
Wil Boren, President, Advanced Surgery
Stacey Eisen, SVP, Global Communications, and President, Baxter International Foundation
Cristiano Franzi, SVP and President, EMEA
Andrew (Andy) Frye, SVP and President, APAC
Heather Knight, GM, U.S. Hospital Products
Sumant Ramachandra, M.D., Ph.D., President, Pharmaceuticals, and SVP, Chief Science and Technology Officer
Reaz Rasul, GM, Acute Therapies
James (Jay) Saccaro, EVP and CFO
Jorge Vasseur, GM, Clinical Nutrition
During a year as challenging as 2020, one might think a company wouldn’t choose that time to publish its first Sustainability Accounting Standards Board index, but that was exactly what Baxter did. According to the company, this is a voluntary public disclosure that provides transparent and relevant corporate responsibility information to investors and other key stakeholders. The report highlights items including ethical marketing, product safety, affordability and pricing, business ethics, and several other areas growing in importance to a rapidly increasing number of members of the public.
“As we strive to address the environmental, social, and governance issues that matter most to our stakeholders, transparency is key—and has been a cornerstone of our work for decades,” said José (Joe) E. Almeida, chairman and CEO of Baxter. “This includes demonstrating the connection between our corporate responsibility initiatives and our business priorities. We are proud of the increasing sophistication of our sustainability efforts and will continue to evolve and broaden our disclosures to best meet stakeholder interests and needs.”
Baxter also found itself, like so many other medical device manufacturers, putting forth significant effort to produce products at a rapid pace to supply healthcare workers with the critical solutions they needed in the fight against COVID-19. The company obtained several emergency use authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its products during the pandemic.
One such device was its Oxiris blood purification filter. As part of a COVID-19 treatment protocol, this technology is used with patients who had been admitted to the intensive care unit with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT). During the therapy, the patient's blood passes through the Oxiris filter set, where it then removes cytokines, endotoxin, and fluid and uremic toxins simultaneously, before returning the patient's blood to the body. Oxiris is the only filter set available in the U.S. that can be used to perform multiple blood purification therapies simultaneously, including CRRT and cytokine removal, according to Baxter.
The firm also obtained EUAs for its HF20 Set and ST Set used in CRRT. Under the EUA, the HF20 Set is authorized to deliver CRRT to treat patients of low weight (8 to 20 kg) and low blood volume who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic. The ST Set is authorized for use under its EUA to provide CRRT to treat patients in an acute care environment during the COVID-19 pandemic. Both the HF20 Set and ST Set can be used with the Prismaflex or PrisMax control units (monitors).
Baxter also received an EUA for Regiocit, the company’s replacement solution that contains citrate for regional citrate anticoagulation of the extracorporeal circuit. Under the EUA, Regiocit is authorized to be used as a replacement solution only in adult patients being treated with CRRT and for whom regional citrate anticoagulation is appropriate during the COVID-19 pandemic.
The organization also presented a number of new products to address other areas of healthcare during the 12-month period that would help ensure organic growth in future fiscal years. Such products included a range of solutions, from a bone graft to a surgical staple reinforcement product.
It announced FDA clearance of the Homechoice Claria automated peritoneal dialysis system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource—the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. The system is cleared for both adult and pediatric populations.
ANALYST INSIGHTS: Due to the market segments in which it participates, Baxter has had revenue challenges due to COVID. Baxter will most likely continue with a steady pace in 2021 with the likelihood for low organic growth and possibly some tuck-in M&A activity.
Approval was also granted for new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These formulations contain up to 80 g/L of amino acids, the highest protein in any multi-chamber bag available in the U.S. (according to Baxter), making it easier to reach patient protein targets while delivering less fluid and dextrose than provided by existing formulations.
A De Novo Authorization was issued for Theranova, Baxter’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa). These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.
The Altapore Shape Bioactive Bone Graft—designed to enhance bone growth and help achieve fusion, which can lead to reduced pain and other improved clinical outcomes for patients—gained FDA clearance during the fiscal year. A 2019 prospective, open-label, non-randomized clinical study evaluated 102 patients with degenerative disc disease, spondylolisthesis, and spinal stenosis undergoing instrumented posterolateral fusion (PLF) procedures per protocol using Altapore Bioactive Bone Graft. The study found that successful fusion was achieved in 86.3 percent of those patients at month 12.
Altapore Bioactive Bone Graft and Altapore Shape share similar properties and handling characteristics, and the study indirectly supported the FDA submission for Altapore Shape. At month 12, patients reported a 60 percent improvement in total pain from baseline using the Visual Analog Scale and a 48 percent improvement in disability from baseline using the Oswestry Disability Index.
The Evo IQ Syringe Infusion System obtained a CE mark and Australian Regulatory Approval during 2020, as well. The system can be used to deliver small volumes of medications and other fluids to patients in a controlled manner. The device joins the Evo IQ large volumetric pump as part of the Evo IQ Infusion Platform, a suite of smart pumps that helps enable clinicians to utilize the technology that helps meet a patient’s specific needs. With patient safety and clinician efficiency central to its design, the Evo IQ Syringe Infusion System is supported by Baxter’s web-based Dose IQ Safety Software and wireless IQ Enterprise Connectivity Suite to help reduce potentially harmful infusion programming errors.
Baxter also announced 510(k) clearance from the FDA for a new generation of its Peri-Strips Dry with Veritas Collagen Matrix product, known as PSDV with Secure Grip. Made available with “peel and secure” technology, PSDV is a staple line reinforcement material that bariatric surgeons have used to mitigate staple line complications for more than 15 years. This new generation of PSDV is two times faster to prepare compared to the previous version and another staple line reinforcement product.
In addition to its new product announcements, Baxter also coordinated with a number of other companies to deliver care and technologies to regions around the globe. These partnerships mark another revenue stream for the firm, although with many of them, the specific financial details were not disclosed.
One such arrangement found Baxter signing a distribution agreement with bioMérieux, a global provider of in-vitro diagnostics, for the NEPHROCLEARTM CCL14 diagnostic test. The test was developed for use in assessing the risk of persistent severe acute kidney injury. The agreement was part of another collaboration, announced during the previous fiscal period, between the two firms to improve identification and treatment of AKI.
Baxter teamed with Ayogo Health, a behavioral science-based digital health company, around unique digital health solutions for home dialysis. Ayogo combined LifePlan—its unique behavior-based digital platform—with Baxter’s expertise in renal care to build mobile apps and digital solutions that bring personalized, relevant, and timely support to patients with kidney failure. Baxter also made an equity investment in Ayogo in exchange for minority interest in the company.
Collaborating on the effort to commercialize VIPUN Medical’s gastric monitoring system to help enhance clinical nutrition, Baxter aligned with the Belgium-based firm. The VIPUN Gastric Monitoring System features a “smart” enteral feeding tube designed to measure stomach motility in order to help clinicians identify enteral feeding intolerance and make better informed nutrition therapy decisions in the intensive care unit and other settings. As part of the agreement, Baxter supported clinical studies required to achieve regulatory approval in key markets worldwide and gain global distribution rights.
Baxter and COSMED collaborated on an FDA 510(k) cleared indirect calorimetry device. The Q-NRG+ metabolic monitoring device can help inform prescription and administration of nutrition therapy, which may include parenteral nutrition, the intravenous administration of nutrients. Per the agreement with COSMED, Baxter has the rights to bring the Q-NRG+ to at least 18 markets around the globe, with the potential for further expansion.
Another partnership brought Baxter together with Spectral Medical for the distribution of MYXIN PMX-20R, a hemoperfusion filter, and the Endotoxin Activity Assay (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis. Baxter agreed to pay Spectral a series of milestone payments including a $5 million upfront rights payment. As a result, Baxter was named Spectral's exclusive distributor of the PMX filter in the U.S. and Canada and gained non-exclusive rights to distribute the EAA globally.
All of these actions will contribute to the continued growth of the firm in the near and distant future. The 2020 fiscal year saw another modest increase for Baxter, which rose from $11.36 billion in 2019 to $11.67 in the latest annual report. The result marked another year of steady growth since at least 2016.
Diving into the specific businesses of Baxter reveals little variation from the single digit changes the organization experience in its annual revenue. Unfortunately, not all units saw increases, however.
The Renal Care segment mirrored the company’s 3 percent gain, increasing from $3.64 billion to $3.76 billion. Medication Delivery went in reverse, shrinking 2 percent between 2019 and 2020 ($2.80 billion to $2.74 billion). Pharmaceuticals decreased only 1 percent, bringing it from $2.16 billion to $2.12 billion. Clinical Nutrition climbed six percent from $872 million to $922 million. Advanced Surgery bumped up 1 percent from $877 million to $888 million. The standout among all businesses was Acute Therapies, which gained 38 percent year over year. The segment went from $535 million to $740 million. The rise was attributed to the significant increase in global demand for Baxter’s CRRT systems to treat acute kidney injuries that emerged during the COVID-19 pandemic. Its Other unit, which includes contract manufacturing services, grew 5 percent ($485 million in 2019 to $508 million in 2020).
$11.67 Billion
Prior Fiscal: $11.40 billion
Percentage Change: +3%
No. of Employees: 50,000
Global Headquarters: Deerfield, Ill.
KEY EXECUTIVES:
José (Joe) E. Almeida, Chairman, President, and CEO
Giuseppe Accogli, SVP and President, Americas and Global Business Units
Laura Angelini, GM, Renal Care
Wil Boren, President, Advanced Surgery
Stacey Eisen, SVP, Global Communications, and President, Baxter International Foundation
Cristiano Franzi, SVP and President, EMEA
Andrew (Andy) Frye, SVP and President, APAC
Heather Knight, GM, U.S. Hospital Products
Sumant Ramachandra, M.D., Ph.D., President, Pharmaceuticals, and SVP, Chief Science and Technology Officer
Reaz Rasul, GM, Acute Therapies
James (Jay) Saccaro, EVP and CFO
Jorge Vasseur, GM, Clinical Nutrition
During a year as challenging as 2020, one might think a company wouldn’t choose that time to publish its first Sustainability Accounting Standards Board index, but that was exactly what Baxter did. According to the company, this is a voluntary public disclosure that provides transparent and relevant corporate responsibility information to investors and other key stakeholders. The report highlights items including ethical marketing, product safety, affordability and pricing, business ethics, and several other areas growing in importance to a rapidly increasing number of members of the public.
“As we strive to address the environmental, social, and governance issues that matter most to our stakeholders, transparency is key—and has been a cornerstone of our work for decades,” said José (Joe) E. Almeida, chairman and CEO of Baxter. “This includes demonstrating the connection between our corporate responsibility initiatives and our business priorities. We are proud of the increasing sophistication of our sustainability efforts and will continue to evolve and broaden our disclosures to best meet stakeholder interests and needs.”
Baxter also found itself, like so many other medical device manufacturers, putting forth significant effort to produce products at a rapid pace to supply healthcare workers with the critical solutions they needed in the fight against COVID-19. The company obtained several emergency use authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for its products during the pandemic.
One such device was its Oxiris blood purification filter. As part of a COVID-19 treatment protocol, this technology is used with patients who had been admitted to the intensive care unit with confirmed or imminent respiratory failure in need of blood purification therapy to reduce pro-inflammatory cytokine levels, including use in continuous renal replacement therapy (CRRT). During the therapy, the patient's blood passes through the Oxiris filter set, where it then removes cytokines, endotoxin, and fluid and uremic toxins simultaneously, before returning the patient's blood to the body. Oxiris is the only filter set available in the U.S. that can be used to perform multiple blood purification therapies simultaneously, including CRRT and cytokine removal, according to Baxter.
The firm also obtained EUAs for its HF20 Set and ST Set used in CRRT. Under the EUA, the HF20 Set is authorized to deliver CRRT to treat patients of low weight (8 to 20 kg) and low blood volume who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic. The ST Set is authorized for use under its EUA to provide CRRT to treat patients in an acute care environment during the COVID-19 pandemic. Both the HF20 Set and ST Set can be used with the Prismaflex or PrisMax control units (monitors).
Baxter also received an EUA for Regiocit, the company’s replacement solution that contains citrate for regional citrate anticoagulation of the extracorporeal circuit. Under the EUA, Regiocit is authorized to be used as a replacement solution only in adult patients being treated with CRRT and for whom regional citrate anticoagulation is appropriate during the COVID-19 pandemic.
The organization also presented a number of new products to address other areas of healthcare during the 12-month period that would help ensure organic growth in future fiscal years. Such products included a range of solutions, from a bone graft to a surgical staple reinforcement product.
It announced FDA clearance of the Homechoice Claria automated peritoneal dialysis system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource—the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. The system is cleared for both adult and pediatric populations.
ANALYST INSIGHTS: Due to the market segments in which it participates, Baxter has had revenue challenges due to COVID. Baxter will most likely continue with a steady pace in 2021 with the likelihood for low organic growth and possibly some tuck-in M&A activity.
—Dave Sheppard, Co-Founder and Managing Director, MedWorld Advisors
Approval was also granted for new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These formulations contain up to 80 g/L of amino acids, the highest protein in any multi-chamber bag available in the U.S. (according to Baxter), making it easier to reach patient protein targets while delivering less fluid and dextrose than provided by existing formulations.
A De Novo Authorization was issued for Theranova, Baxter’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa). These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.
The Altapore Shape Bioactive Bone Graft—designed to enhance bone growth and help achieve fusion, which can lead to reduced pain and other improved clinical outcomes for patients—gained FDA clearance during the fiscal year. A 2019 prospective, open-label, non-randomized clinical study evaluated 102 patients with degenerative disc disease, spondylolisthesis, and spinal stenosis undergoing instrumented posterolateral fusion (PLF) procedures per protocol using Altapore Bioactive Bone Graft. The study found that successful fusion was achieved in 86.3 percent of those patients at month 12.
Altapore Bioactive Bone Graft and Altapore Shape share similar properties and handling characteristics, and the study indirectly supported the FDA submission for Altapore Shape. At month 12, patients reported a 60 percent improvement in total pain from baseline using the Visual Analog Scale and a 48 percent improvement in disability from baseline using the Oswestry Disability Index.
The Evo IQ Syringe Infusion System obtained a CE mark and Australian Regulatory Approval during 2020, as well. The system can be used to deliver small volumes of medications and other fluids to patients in a controlled manner. The device joins the Evo IQ large volumetric pump as part of the Evo IQ Infusion Platform, a suite of smart pumps that helps enable clinicians to utilize the technology that helps meet a patient’s specific needs. With patient safety and clinician efficiency central to its design, the Evo IQ Syringe Infusion System is supported by Baxter’s web-based Dose IQ Safety Software and wireless IQ Enterprise Connectivity Suite to help reduce potentially harmful infusion programming errors.
Baxter also announced 510(k) clearance from the FDA for a new generation of its Peri-Strips Dry with Veritas Collagen Matrix product, known as PSDV with Secure Grip. Made available with “peel and secure” technology, PSDV is a staple line reinforcement material that bariatric surgeons have used to mitigate staple line complications for more than 15 years. This new generation of PSDV is two times faster to prepare compared to the previous version and another staple line reinforcement product.
In addition to its new product announcements, Baxter also coordinated with a number of other companies to deliver care and technologies to regions around the globe. These partnerships mark another revenue stream for the firm, although with many of them, the specific financial details were not disclosed.
One such arrangement found Baxter signing a distribution agreement with bioMérieux, a global provider of in-vitro diagnostics, for the NEPHROCLEARTM CCL14 diagnostic test. The test was developed for use in assessing the risk of persistent severe acute kidney injury. The agreement was part of another collaboration, announced during the previous fiscal period, between the two firms to improve identification and treatment of AKI.
Baxter teamed with Ayogo Health, a behavioral science-based digital health company, around unique digital health solutions for home dialysis. Ayogo combined LifePlan—its unique behavior-based digital platform—with Baxter’s expertise in renal care to build mobile apps and digital solutions that bring personalized, relevant, and timely support to patients with kidney failure. Baxter also made an equity investment in Ayogo in exchange for minority interest in the company.
Collaborating on the effort to commercialize VIPUN Medical’s gastric monitoring system to help enhance clinical nutrition, Baxter aligned with the Belgium-based firm. The VIPUN Gastric Monitoring System features a “smart” enteral feeding tube designed to measure stomach motility in order to help clinicians identify enteral feeding intolerance and make better informed nutrition therapy decisions in the intensive care unit and other settings. As part of the agreement, Baxter supported clinical studies required to achieve regulatory approval in key markets worldwide and gain global distribution rights.
Baxter and COSMED collaborated on an FDA 510(k) cleared indirect calorimetry device. The Q-NRG+ metabolic monitoring device can help inform prescription and administration of nutrition therapy, which may include parenteral nutrition, the intravenous administration of nutrients. Per the agreement with COSMED, Baxter has the rights to bring the Q-NRG+ to at least 18 markets around the globe, with the potential for further expansion.
Another partnership brought Baxter together with Spectral Medical for the distribution of MYXIN PMX-20R, a hemoperfusion filter, and the Endotoxin Activity Assay (EAA), an on-market companion diagnostic tool that aids in the risk assessment of ICU patients for progression to severe sepsis. Baxter agreed to pay Spectral a series of milestone payments including a $5 million upfront rights payment. As a result, Baxter was named Spectral's exclusive distributor of the PMX filter in the U.S. and Canada and gained non-exclusive rights to distribute the EAA globally.
All of these actions will contribute to the continued growth of the firm in the near and distant future. The 2020 fiscal year saw another modest increase for Baxter, which rose from $11.36 billion in 2019 to $11.67 in the latest annual report. The result marked another year of steady growth since at least 2016.
Diving into the specific businesses of Baxter reveals little variation from the single digit changes the organization experience in its annual revenue. Unfortunately, not all units saw increases, however.
The Renal Care segment mirrored the company’s 3 percent gain, increasing from $3.64 billion to $3.76 billion. Medication Delivery went in reverse, shrinking 2 percent between 2019 and 2020 ($2.80 billion to $2.74 billion). Pharmaceuticals decreased only 1 percent, bringing it from $2.16 billion to $2.12 billion. Clinical Nutrition climbed six percent from $872 million to $922 million. Advanced Surgery bumped up 1 percent from $877 million to $888 million. The standout among all businesses was Acute Therapies, which gained 38 percent year over year. The segment went from $535 million to $740 million. The rise was attributed to the significant increase in global demand for Baxter’s CRRT systems to treat acute kidney injuries that emerged during the COVID-19 pandemic. Its Other unit, which includes contract manufacturing services, grew 5 percent ($485 million in 2019 to $508 million in 2020).