Prior Fiscal: $18.86 Billion
Percentage Change: +5.8%
No. of Employees: 107,000 (total)
Global Headquarters: Abbott Park, Ill.
Miles D. White, Executive Chairman of the Board
Robert B. Ford, President and CEO
Robert E. Funck Jr., Exec. VP, Finance and CFO
Lisa D. Earnhardt, Exec. VP, Medical Devices
John F. Ginascol, Exec. VP, Core Diagnostics
Andrea F. Wainer, Exec. VP, Rapid and Molecular Diagnostics
Chuck Brynelsen, Sr. VP, Abbott Vascular
Michael Dale, Sr. VP, Structural Heart
Jaime Contreras, Sr. VP, Core Laboratory Diagnostics, Commercial Operations
Michael J. Pederson, Sr. VP, Electrophysiology and Heart Failure
Christopher J. Scoggins, Sr. VP, Rapid Diagnostics
Jared L. Watkin, Sr. VP, Diabetes Care
Randel Woodgrift, Sr. VP, Cardiac Rhythm Management
Last November, scientists working with advanced DNA sequencing technology documented a hitherto unidentified strain of HIV under the group responsible for the majority of human infections.
Though found in only three people, the findings by Abbott Laboratories—an HIV test maker—will stir conversation about how to classify new surfacing viral strains. Strains from HIV Group M are most common and are responsible for the global AIDS pandemic, affecting about 90 percent of the 37.9 million people the World Health Organization estimated were living with HIV in 2018.
Abbott’s findings established a 10th group M strain, the first identified since 2000. It was traced to the Democratic Republic of Congo, where the first HIV infection in humans emerged in the mid-1900s. According to The Wall Street Journal, researchers and epidemiologists don’t expect the new strain to change the way HIV is diagnosed or treated. But new strains can offer clues about how HIV evolved and spread.
“There’s a lot of mystery around why certain things happened. New strains can unravel some of that unknown history,” Brian Foley, an HIV geneticist at New Mexico’s Los Alamos National Laboratory, which holds the largest HIV gene bank and sets the guidelines on classifying new strains, told Forbes. He said the findings could help achieve the ultimate goal in fighting HIV, a vaccine.
The new Group M strain, called L, was spotted by Abbott’s global surveillance program, which seeks out unusual HIV and hepatitis strains. The program helps keep Abbott’s diagnostics tests up to speed. With $7.7 billion in sales (up 5.9 percent from the prior fiscal year) the global medical device maker’s diagnostics business makes up about 39 percent of its $19.95 billion medical technology revenue—up 5.8 percent from 2018. Growth was seen across all four segments: core laboratory, molecular, point of care, and rapid diagnostics, the latter of which grew by 400 percent due to Alere’s full integration.
The Alinity m diagnostics system and assays earned a CE mark last March. Initial assays included HIV-1, hepatitis B virus, and hepatitis C virus; sexual health-related testing for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium or CT/NG/TV/MG panel; and high-risk human papillomavirus (HPV) testing. Alinity m can potentially shrink lab equipment footprint from four to six instruments down to one.
The FDA approved the Alinity s blood and plasma screening system in July. The new system can run up to 600 tests an hour, increases “walk-away time” (when lab workers are free to manage other responsibilities as samples are processed) to a minimum of three hours, and allows continuous sample load and unload. An intuitive software interface, menu design, and sample loading layout also flattens the device’s learning curve.
September saw an FDA nod for the ARCHITECT STAT High Sensitivity Troponin-I blood test for heart attack diagnosis. The test measures very low levels of troponin so heart attack patients can be evaluated within two to four hours. According to a study in BMJ, women may particularly benefit from the high-sensitivity test because they often have lower troponin levels than men, which contemporary troponin tests might miss.
The Determine HBsAg test to spot hepatitis B surface antigen in serum, plasma, or whole blood received a CE mark last February. Deployed at the point of care, the highly sensitive lateral flow test detects the hepatitis B virus in 15 minutes with an analytical sensitivity of 0.1 IU/mL.
Last June saw the launch of the Afinion HbA1c Dx assay on the Afinion 2 and Afinion AS100 analyzers. The rapid point-of-care test generates glycated hemoglobin results in about three minutes so diabetes can be diagnosed and an individualized care plan developed in one doctor’s visit.
Last April, the company began the next phase of a partnership with the U.S. Department of Defense and researchers from the TRACK-TBI Network by starting a clinical trial to assess Abbott’s point-of-care i-STAT Alinity blood test technology under development to evaluate brain injuries in minutes using only a few drops of blood.
“Whether on the battlefield or in the emergency room, we need quick and accurate information to help assess a person who may have sustained brain injury,” said Geoffrey T. Manley, M.D., Ph.D., principal investigator of TRACK-TBI, neurosurgeon, and professor of neurosurgery, University of California, San Francisco. “Our goal with this partnership is to validate the scientific rigor behind new technologies, like this blood test, and how they can help ensure the best care for our troops and patients.”
The Medical Devices business was responsible for the remaining $12.25 billion in revenue, reaching double-digit growth with 10.5 percent. The Diabetes Care, Structural Heart, Electrophysiology, and Heart Failure portfolios’ double-digit revenue expansions were the main drivers for Abbott’s success last year. Structural heart revenue growth was broad-based across several areas of the business. Heart failure segment growth reflected rapid U.S. market adoption of the HeartMate 3 Left Ventricular Assist Device and higher CardioMEMS heart failure monitoring system sales.
Higher 2019 international rhythm management sales were offset by a 4.4 percent decrease in U.S. revenue. The next generation of the paperclip-sized Confirm Rx insertable cardiac monitor (ICM) won both FDA and CE mark approval last May. The Confirm Rx ICM combines smartphone connectivity and continuous, remote monitoring to track unpredictable heart rhythm problems. It is the only ICM device on the market that syncs to a smartphone via Bluetooth. It also features a mobile app so an additional transmitter isn’t needed.
Electrophysiology sales grew thanks to high global sales of cardiac diagnostic and ablation catheters. The TactiCath Contact Force Ablation Catheter, Sensor Enabled also obtained FDA approval last January to treat AFib. It delivers more precise heart images overlaid with real-time electrical activity information. “Contact force” technology prevents surgeons from applying too much or insufficient pressure to heart tissue during cardiac ablation procedures. TactiCath’s design allows for better reach and maneuverability, according to Abbott.
The structural heart business kicked off its year by acquiring a less-invasive mitral valve replacement in development from privately held Cephea Valve Technologies for an undisclosed amount. The artificial valve is delivered through a vein in the leg to forego the need for open-heart surgery. Abbott’s minimally invasive mitral valve disease business now includes two valve replacements (Tendyne in 2015 and Cephea) and the MitraClip valve repair device.
Last January, Abbott won FDA approval for Amplatzer Piccolo, which (according to Abbott) was the world’s first device that can be minimally invasively implanted in babies weighing as little as two pounds to treat patent ductus arteriosus (PDA), a common congenital opening in the heart. Smaller than a small pea, the self-expanding, wire mesh implant is inserted using a transcatheter approach via the leg. The approval is a significant advance to treat premature infants and newborns with PDA who are non-responsive to medical management and a high risk for surgery. Amplatzer Piccolo nabbed a CE mark in September.
“This approval is a potentially life-saving advance for the very smallest premature infants that will help us treat these delicate babies who might otherwise not be able to survive,” said Evan Zahn, M.D., director of the Congenital Heart Program at Cedars-Sinai's Smidt Heart Institute, and principal investigator for the study that led to FDA approval.
Supported by the landmark COAPT trial’s positive results, The MitraClip transcatheter clip-based therapy won expanded FDA indication for difficult-to-treat heart failure patients with secondary mitral regurgitation last March. According to Abbott, MitraClip then became the first transcatheter mitral valve intervention therapy to treat patients fitting that description.
MitraClip G4, the fourth-generation of MitraClip, got an FDA nod in July. It has been enhanced with a larger clip size range (four sizes), alternative leaflet grasping feature, and real-time facilitation of procedure assessment. An upgraded catheter with an integrated pressure monitor provides real-time continuous left atrial pressure monitoring during implantation.
A first of its kind in the U.S., the TRILUMINATE Pivotal IDE trial evaluating Abbott’s TriClip catheter-based, non-surgical tricuspid valve repair for severe tricuspid regurgitation began in September with first enrollments at Minneapolis’ Abbott Northwestern Hospital. The study enrolled 700 patients in total. Alongside the study, TriClip was accepted for parallel FDA and Centers for Medicare and Medicaid Services (CMS) review.
Neuromodulation sales declined 4 percent from the previous year. The Proclaim XR recharge-free spinal cord stimulator for chronic pain obtained FDA approval in September. It uses low energy proprietary BurstDR therapy coupled with BoldXR low dosing protocol, and has a battery life of up to 10 years. Low-energy stimulation finds the lowest effective dose as determined by the treating clinician. Proclaim XR also uses Apple mobile digital devices and Bluetooth to help discreetly manage pain.
Although Abbott’s diabetes business released no new products last year, the continued success of the FreeStyle Libre continuous glucose monitoring system kept the segment thriving. The $1.8 billion in FreeStyle Libre sales in 2019 was a whopping 69.8 percent increase over 2018. The company also entered into a number of partnerships with firms with expertise in technologies complementary to FreeStyle Libre.
February: Integrating insulin dose data from Novo Nordisk’s prefilled and durable connected insulin pens into digital health tools compatible with FreeStyle Libre. Glucose and insulin data can then be viewed together for more meaningful, productive health conversation.
September: Combining FreeStyle Libre with global biopharmaceutical firm Sanofi’s insulin dosing information for future smart pens, insulin titration apps, and cloud software.
October: Integrating FreeStyle Libre with the Omada Health digital care program. The combined solution will generate real-time glucose data and actionable information for better management and will provide personalized recommendations.
October: Developing and commercializing integrated diabetes solutions combining FreeStyle Libre with Tandem Diabetes Care’s t:slim X2 insulin pump. t:slim X2 was the first to earn FDA clearance in a new device category called alternate controller enabled (ACE) pumps early in 2019. ACE pumps have special controls for reliable, secure communication with compatible external devices like FreeStyle Libre. Combining the two would allow diabetes patients to choose tools and tailor management to their needs.
Under New Management
Twenty-one-year CEO Miles D. White (the second longest tenure for a non-founder in today’s S&P 100) announced his retirement at age 64 in November. He remains as executive chairman, and 23-year Abbott veteran, president, and Chief Operating Officer Robert B. Ford succeeded White on March 31 of this year.
Named chairman and CEO in 1998, White strategically reshaped Abbott many times, most recently by adding medical device maker St. Jude Medical Inc. and diagnostics firm Alere in 2017. He also led the spinouts of hospital products business Hospira Inc. in 2004 (acquired by Pfizer for $17 billion in 2015) and drug business AbbVie (now valued at over $125 billion) in 2013. Abbott’s market capitalization hovered around $75 billion when White took over, and has soared to $149 billion in 2019, according to Forbes.
“We are deeply grateful for the leadership and strategic direction Miles has provided over the past two decades,” said William A. Osborn, lead director and chair of the Nominations and Governance Committee of Abbott's Board of Directors. “He embodies the values of the company in every respect and his impact on employees, shareholders, and most importantly, patients, will continue for years to come. He has positioned Abbott well for continued top-tier growth and innovation and we thank him for his countless contributions.”
Q2 2020 Medical Device & Diagnostics Revenue: $4.4 Billion
Q2 2019 Medical Device & Diagnostics Revenue: $5 Billion
Percentage Change: -12%
The RealTime SARS-CoV-2 molecular test gained EUA on March 18. The test is run on the company’s m2000 RealTime System, which can run up to 470 tests in 24 hours. The company immediately began shipping 150,000 tests to existing U.S. customers after receiving FDA authorization.
On March 28, Abbott gained EUA for a molecular point-of-care test that can detect COVID-19 in five minutes with negative results in 13 minutes. It runs on the ID NOW platform, which weighs 6.6 pounds and is about the size of a small toaster. The test can be conducted in physicians’ offices, urgent care clinics, and hospital ERs. ID NOW COVID-19 tests became available in urgent care settings the week of March 30.
Abbott’s FreeStyle Libre 14-day continuous glucose monitor was cleared for use in hospitals on April 8, minimizing diabetes patients’ exposure to the virus. According to the CDC, over half of all diabetes patients diagnosed with COVID-19 are hospitalized.
The company launched a serology blood test to detect the antibody IgG that identifies if a person has had COVID-19. It will shed light on how long antibodies stay in the body and if they provide immunity, potentially supporting treatment and vaccine development.
On April 15, CEO Robert Ford was named to the White House task force designated by President Trump to provide recommendations on how best to safely reopen the U.S. economy in the wake of the pandemic.
Abbott gained EUA on May 11 for its SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. The company shipped almost 30 million antibody tests in May.
A COVID-19 molecular test for the new Alinity m molecular laboratory instrument received FDA emergency authorization on May 12. Alinity m can run up to 1,080 tests in 24 hours.
The FDA warned on May 15 that early data (15 adverse event reports) suggested Abbott’s ID NOW point-of-care test to diagnose COVID-19 may return false negatives. One New York University study found it missed close to half of the positive samples detected by a rival company’s test. But later that month a senior FDA official said COVID-19 tests outside lab setting would be considered useful in fighting the pandemic even if they missed one in five positive cases. According to federal contract records, over $205 million worth of contracts have been issued by the U.S. government for the tests.
Calling the NYU research “flawed,” Abbott immediately underwent a multi-site clinical study, and reported interim results a week later that determined test performance is ≥94.7 percent in positive agreement (sensitivity) and ≥98.6 percent negative agreement (specificity) when compared to two different lab-based PCR reference methods.
By June, however, the FDA had received 106 adverse event reports for the test. The agency has not received a single adverse event report for any other point-of-care tests meant to diagnose COVID-19, an FDA spokesperson told Kaiser Health News. Medical professionals are split over the FDA’s proclaimed 80 percent threshold.
“There’s no way I would be comfortable missing 2 out of 10 patients,” said Susan Whittier, director of clinical microbiology at NewYork-Presbyterian/Columbia University Medical Center.
Abbott has since made several revisions for how its rapid test should be performed. It previously removed language saying swabs could be placed in viral transport medium before the test is run to remove risk of dilution. In the latest, only direct swabs from patients should be inserted in the analyzer. Abbott also revised instructions for handling patient specimens.
“The difference now,” said Christopher Polage, medical director of Duke University Health System’s clinical microbiology lab, “is that people are so fearful and tolerance for false negatives is just zero.”