Abbott Q1 Earnings: Strong Growth, Solid Start

Abbott is well-positioned to deliver on its 2021 guidance, thanks to strong growth across the company's major businesses.

Abbott Q1 Earnings: Strong Growth, Solid Start
Strategy and Strength | Apr. 20, 2021

The first quarter is a wrap and Abbott is off to a very good start with strong growth across all four of the company's major businesses.

This growth translated to worldwide sales for the quarter of $10.5 billion, up 32.9% on an organic basis (35.3% reported), excluding the impact of foreign exchange. Abbott's ongoing earnings per share was $1.32, reflecting 103.1% growth compared to the prior year.1

While Diagnostics led Abbott's growth, driven by the company's robust portfolio of COVID-19 tests, that’s only part of the story. This quarter also saw strong growth in Adult Nutrition, Medical Devices — led by Diabetes Care and Structural Heart — as well as increasing demand for other instruments and routine tests in Abbott's Core Lab business.

Given this strong quarter, Abbott is on track with its expectations for the year and well-positioned to deliver on its 2021 guidance, reflecting another year of impressive performance.

These are some of the key first-quarter highlights:

  • Strong Medical Device sales, up 8.8% organic (13.1% reported), were driven by continued recovery from the COVID-19 pandemic. Leading this growth for the quarter was Diabetes Care, with $829 million in sales of Abbott's FreeStyle Libre system and Libre Sense. The FreeStyle Libre system now has more than 3 million users worldwide.2
  • Significant growth in Diagnostics, 114.8% organic (119.8% reported), was once again driven by demand for Abbott’s robust and global portfolio of rapid and lab-based COVID-19 diagnostics tests, which can be used in a variety of settings. The latest is Abbott's rapid antigen BinaxNOW COVID-19 Self Test, an over-the-counter test for people with or without symptoms, which is shipping to retailers across the U.S. this week. The test received emergency use authorization (EUA) in April from the U.S. Food and Drug Administration (FDA). Overall, Abbott has provided nearly 700 million COVID-19 diagnostics tests since the start of the pandemic.

    Excluding COVID-19 sales, Core Lab and Molecular Diagnostics sales had double-digit growth on an organic basis in the quarter.3
  • Strong Nutrition growth, of 6.4% organic (6.9% reported) was spurred by demand for Abbott's Adult Nutrition products, which had double-digit growth led by Ensure, Abbott’s market-leading nutrition brand and Glucerna, Abbott’s best-in-class diabetes nutrition product.
  • New approvals in the quarter have added more momentum to Abbott’s already strong portfolio of life-changing technologies. This includes two first-of-their-kind innovations with Abbott receiving FDA clearance for its i-STAT Alinity TBI plasma test* (the first rapid handheld objective blood test for traumatic brain injury) and FDA approval of NeuroSphere Virtual Clinic (a first-of-its-kind technology allowing patients with chronic pain or movement disorders to receive new treatment settings remotely).

    Abbott also received EUA from the FDA in March for its Alinity m Resp-4-Plex test, allowing healthcare workers to detect four respiratory viruses (influenza types A and B, RSV and COVID-19) with just one swab. And in April, Abbott announced CE Mark for its next-generation TriClip device,** a minimally invasive therapy providing a new treatment option for a common heart valve issue.

For full financials and reconciliation of non-GAAP measures, you can read Abbott's press release. For further information, take a look at some additional materials below:

Abbott President and CEO Robert Ford shares his thoughts on the continued importance of rapid COVID-19 tests.

Abbott Q1 Earnings: Strong Growth, Solid Start

Download a summary of Abbott’s earnings highlights here.

Abbott Q1 Earnings: Strong Growth, Solid Start

* The i-STAT Alinity TBI plasma test simultaneously measures biomarkers glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in blood plasma, two complementary biomarkers that, in elevated concentrations, are tightly correlated to brain injury. It provides test results with 95.8% sensitivity and greater than 99% negative predictive value. The TBI blood test was developed in collaboration with the U.S. Department of Defense (DoD) – which has been dedicated to developing a solution for the objective detection and evaluation of TBI for more than a decade. The DoD, through U.S. Army Medical Research and Development Command's (USAMRDC) U.S. Army Medical Materiel Development Activity (USAMMDA), played a critical role in developing the test run on Abbott's i-STAT Alinity platform. The Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) research team were the first to demonstrate how this TBI blood test can be used for the benefit of TBI patients in clinical care.

** TriClip G4 is an investigational device only in the U.S.

References

1 First-quarter 2021 diluted EPS from continuing operations on a GAAP basis reflects 233.3 percent growth.
2 Data on file. Abbott Diabetes Care.
3 Excluding COVID-19 testing-related sales, Core Laboratory Diagnostics sales increased 14.1 percent and Molecular Diagnostics sales increased 33.9 percent on a reported basis in the first quarter.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. Abbott cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Abbott's operations are discussed in Item 1A, "Risk Factors" in our Annual Report on Form 10-K for the year ended Dec. 31, 2020, and are incorporated herein by reference. Abbott undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Important safety information

Alinity™ m Resp-4-Plex
FreeStyle Libre 2 Indications and Important Safety Information
BINAXNOW EMERGENCY USE AUTHORIZATION

The BinaxNOW™ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older.

The BinaxNOW COVID-19 Ag 2 Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swab samples from COVID-19 symptomatic individuals tested twice over three days with at least 36 hours between tests within the first seven days of symptom onset.

This test is authorized for use with direct anterior nasal (nares) swab samples from individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested twice over three days with at least 36 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

The BinaxNOW COVID-19 Ag Card 2 Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection when tested twice over three days with at least 36 hours between tests. This test is authorized for non-prescription home use with self-collected observed direct anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal swab samples from individuals aged two years or older. The BinaxNOW COVID-19 Ag Card 2 Home Test is to be performed only with the supervision of a telehealth proctor.

The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. The tests have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Alinity™ m Resp-4-Plex

For use under an Emergency Use Authorization only.

  • This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
  • Use of the Alinity m Resp-4-Plex assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Alinity m System.
  • Laboratories are required to report all SARS-CoV-2 results to the appropriate public health authorities.
  • The instrument and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
  • Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert).
  • Detection of flu A, flu B, RSV, or SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
  • Recent patient exposure to FluMist® or other attenuated influenza vaccines may cause inaccurate positive results for flu A and flu B due to the presence of attenuated viruses.
  • False-negative results may arise from degradation of the viral RNA during storage and transport of the specimens.
  • As with any molecular test, mutations within the target regions of Alinity m Resp-4-Plex assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
  • Results should be interpreted by a trained professional in conjunction with the patient's history and clinical signs and symptoms, and epidemiological risk factors.
  • Negative results do not preclude infection with the flu A, flu B, RSV, or SARS-CoV-2 and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.
  • Self-collected under supervision of or healthcare provider collected nasal swabs are additional acceptable upper respiratory specimens that can be tested with the Alinity m Resp-4-Plex assay; however, performance with this specimen type has not been validated.
  • Influenza was validated in the clinical study by testing archived, selected specimens only. If an influenza result is inconsistent with clinical presentation and/or other clinical and epidemiological information, FDA-cleared Influenza NAATs are available for confirmation if clinically indicated.
  • A positive result indicates the detection of nucleic acid from the relevant virus. Nucleic acid may persist even after the virus is no longer viable.

FDA EMERGENCY USE AUTHORIZATION

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;

  • This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
FreeStyle Libre 2 Indications and Important Safety Information

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*

WARNINGS/LIMITATIONS*:

The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.

*Please refer to www.freestylelibre.us for the indications and important safety information.

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