Abbott Beats Analyst Estimates, Raises Guidance

Abbott reports strong double-digit earnings and sales growth fueled by all of its major businesses.

Strategy and Strength|Oct.20, 2021

As we've seen throughout the pandemic, Abbott's diverse business portfolio continues to be highly resilient, reflected by its strong third-quarter results.

Based on the company's strong performance — including double-digit earnings and sales growth — and the company's outlook, Abbott raised its 2021 adjusted diluted earnings-per-share1 (EPS) guidance from continuing operations to $5.00 – 5.10,2 which reflects 38.4% growth at the midpoint compared to last year.3

Here are the key numbers:

  • $10.9 billion in worldwide sales, up 22.4% organic* (23.4% reported) versus the third quarter of 2020.

  • $1.40 adjusted diluted EPS, reflecting 42.9% growth compared to the prior year.4

Comparing these results to a pre-pandemic baseline illustrates the true strength of Abbott's businesses. Sales — excluding COVID-19 testing — grew double digits, 11.7% on both an organic and reported basis versus pre-pandemic levels in the third quarter of 2019.

These are the key third-quarter highlights:

  • Solid Medical Devices sales — 13.1% organic (14.6% reported) — spurred by continued recovery from the COVID-19 pandemic and strong growth in Diabetes Care. This growth was driven by sales of FreeStyle Libre systems and Libre Sense, $968 million in the quarter, which translates to an increase of 38.8% organic (41.6% reported).

  • Robust growth in Diagnostics — 46.8% organic (48.2% reported) — with COVID-19 testing-related sales of $1.9 billion, of which approximately $1.6 billion were rapid tests. Excluding COVID-19 testing-related sales, global diagnostics sales increased 12.5% organic (14.1% reported).

  • Strong Nutrition sales — up 8.9% organic (9.6% reported) — driven by international adult and U.S. pediatric Nutrition, with strong performance of Abbott's market-leading brands Ensure, Glucerna and Pedialyte.

  • Highly productive pipeline — Several new products launched in large, high-growth markets, including Amplatzer Amulet, Portico with FlexNav TAVR system and the FreeStyle Libre 2 iOS app in the U.S. — and there's more expected. Abbott also expanded its Vascular portfolio with the acquisition of Walk Vascular, LLC, a commercial-stage medical device company with a minimally invasive thrombectomy system designed to remove peripheral blood clots.

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 summarizes the company’s third-quarter results and full-year outlook.

Abbott Beats Analyst Estimates, Raises Guidance

Download a summary of Abbott's earnings highlights here.

Third Quarter - 2021 Results

*Organic sales growth excludes the impact of foreign exchange.


1 Adjusted diluted EPS excludes specified items primarily related to intangible amortization, restructuring and cost reduction initiatives, expenses associated with acquisitions and other net expenses. Abbott forecasts specified items for the full-year 2021 of $1.45 per share.
2 Abbott projects 2021 diluted EPS from continuing operations on a GAAP basis of $3.55 to $3.65.
3 Full year 2021 guidance for diluted EPS from continuing operations on a GAAP basis reflects growth of 44.5% at the mid-point versus prior year.
4 Third-quarter 2021 diluted EPS from continuing operations on a GAAP basis reflects 69.6% growth.

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.





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.*


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 * for detailed indications for use and safety information.

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



The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at or at for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

  • with the presence of intracardiac thrombus,
  • with active endocarditis or other infections producing bacteremia.
  • where placement of the device would interfere with any intracardiac or intravascular structures.


  • If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
  • Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.
  • Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.
  • Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.

The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

  • Do not use this device if the sterile package is open or damaged.
  • The device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use on or before the expiration date that is printed on the product packaging label.


  • The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.
  • The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.
  • The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.
  • Ensure that the vasculature is adequate for the sheath size being selected.
  • The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.
  • Use standard interventional cardiovascular catheterization techniques when using Amplatzer™ products.
  • Use in specific populations
    - Pregnancy – Minimize the radiation exposure to the fetus and the mother.
    - Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:

  • Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
  • Maximum spatial gradient field of 19 T/m (1900 G/cm)
  • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

  • Air embolism
  • Airway trauma
  • Allergic reaction
  • Anemia
  • Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
  • Arrhythmia
  • Atrial septal defect
  • Bleeding
  • Cardiac arrest
  • Cardiac tamponade
  • Chest pain/discomfort
  • Congestive heart failure
  • Death
  • Device embolization
  • Device erosion
  • Device malfunction
  • Device malposition
  • Device migration
  • Device-related thrombus
  • Fever
  • Hematuria
  • Hypertension/hypotension
  • Infection
  • Multi-organ failure
  • Myocardial infarction
  • Perforation
  • Pericardial effusion
  • Pleural effusion
  • Renal failure/dysfunction
  • Respiratory failure
  • Seizure
  • Significant residual flow
  • Stroke
  • Thrombocytopenia
  • Thromboembolism: peripheral and pulmonary
  • Thrombus formation
  • Transient ischemic attack
  • Valvular regurgitation/insufficiency
  • Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
  • Vessel trauma/injury

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at or at for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.




The Portico™ Transcatheter Aortic Valve Implantation System is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).

The valve is contraindicated for patients with inability to tolerate antiplatelet/anticoagulant therapy or nitinol alloy (nickel and titanium), or who have active infections, including endocarditis.

Carefully read all warnings, precautions, and instructions for use for all components of the system before use. Failure to read and follow all instructions or failure to observe all stated warnings could cause serious injury or death to the patient.

  • Perform Portico™ valve implantation in a facility where emergency aortic valve surgery is available.
  • Verify that the patient’s anatomy is consistent with the specifications set forth in the anatomical specifications tables 2 and 3 (found in IFU).
  • For single use only. Do not reuse, reprocess, or resterilize the valve, delivery system, or the loading system. Reuse, reprocessing, and/or resterilization creates a risk of contamination of the devices and/or device failure, which could cause patient injury, illness or death.
  • Do not manipulate or handle the valve with sharp or pointed objects.
  • Rinse the valve as directed before loading the valve onto the delivery system.
  • Do not use the valve, the delivery system, or the loading system if the “USE BY” date has elapsed.
  • Exercise care to prevent kinking of the delivery system when removing it from the packaging.
  • This device contains nitinol, an alloy of nickel and titanium. Persons with allergic reactions to these metals may suffer an allergic reaction to this implant. Prior to implantation, patients should be counseled on the materials contained in the device, as well as potential for allergy/hypersensitivity to these materials.
  • Accelerated deterioration of the valve due to calcific degeneration may occur in children, adolescents, young adults, or patients with altered calcium metabolism.

Pre-Implantation Precautions

  • The safety, effectiveness, and durability of a Portico™ valve implanted within a surgical or transcatheter bioprosthesis have not been demonstrated.
  • Long-term durability has not been established for the Portico valve. Regular medical follow-up is advised to evaluate valve performance.
  • For transaortic access, ensure the access site and trajectory are free of internal patent right internal mammary artery (RIMA) or pre-existing patent RIMA graft.
  • For subclavian/axillary access, use caution in patients with mammary artery grafts.
  • Balloon aortic valvuloplasty (BAV) of the native aortic valve is recommended prior to delivery system insertion. The balloon size chosen should be appropriate, not exceeding the minimum diameter of the native aortic annulus as assessed by CT imaging to minimize risk of annular rupture and not undersized to minimize risk of stent under-expansion which could lead to paravalvular leak (PVL) or device migration.
  • Do not use the valve if the shipping temperature indicator on the product package has turned red, or if the valve has been improperly stored in temperature conditions outside of the 5°C–25°C (41°F–77°F) range.
  • Do not use the valve if the tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
  • Do not advance the delivery system without the guidewire extending from the tip.
  • Do not use the valve without thoroughly rinsing as directed.
  • Do not use the delivery system without thoroughly flushing as described in the "Directions for Use" section.
  • The safety and effectiveness of the Portico™ valve and FlexNav™ delivery system have not been evaluated in the following patient populations:

- Congenital unicuspid or bicuspid valve, or any leaflet configuration other than tricuspid
- Severe ventricular dysfunction with left ventricular ejection fraction <20%
- Non-calcific aortic annulus
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Patients at low or intermediate surgical risk
- Patients who are pregnant or breastfeeding
- Pediatric patients (less than 21 years of age)
- Patients with a pre-existing prosthetic heart valve or prosthetic ring in any position
- Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > 3+)
- Patients with severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise
- Blood dyscrasias as defined: leukopenia (WBC<3000 mm³), acute anemia (Hb < 9 g/dL), thrombocytopenia (platelet count <50,000 cells/mm³)
- Patients with untreated clinically significant coronary artery disease requiring revascularization
- Patients with bulky calcified aortic valve leaflets in close proximity to coronary ostia
- Hypertrophic cardiomyopathy with or without obstruction (HOCM)
- Renal insufficiency (creatinine > 3.0 mg/dL) and/or end stage renal disease requiring chronic dialysis
- Hemodynamic instability requiring inotropic support or mechanical heart assistance
- Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma (especially if thick [> 5 mm], protruding or ulcerated) or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe “unfolding” and tortuosity of the thoracic aorta
- Patients with known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media which cannot be adequately premedicated
- Patients with access characteristics that would preclude safe placement of the introducer sheath, when necessary, such as severe obstructive calcification, or severe tortuosity


Implantation Precautions

  • To minimize risk of guidewire perforations in the left ventricle, a manufacturer pre-shaped guidewire should be used during the procedure and during valve deployment.
  • Do not deploy the valve if excessive resistance to deployment is encountered. If the valve does not deploy easily, re-sheath the valve, remove it from the patient, and use a different valve and delivery system.
  • Follow the procedure in “Implanting the Valve” to reposition the valve or to remove the valve from the patient.
  • Do not attempt to reposition the valve by advancing it distally unless the valve has been fully re-sheathed within the delivery system.
  • Do not re-sheath the valve more than two times prior to final valve release. Additional re-sheath attempts may compromise product performance.
  • To minimize likelihood of permanent pacemaker implantation (PPI): a) maintain implant depth of 3mm, and b) limit manipulations across the LVOT.

Post-Implantation Precautions

  • In the event that a post-implant balloon dilatation is performed to address paravalvular leak (PVL), valve size, patient anatomy, and implant depth must be considered when selecting the size of the balloon for dilatation. The balloon size chosen should not exceed the mean diameter of the native aortic annulus. Moderate or Severe PVL should be addressed at the time of the TAVI procedure.
  • Exercise care when removing the delivery system from the patient.
  • Exercise care when crossing the valve with adjunctive devices.
  • Once the valve is fully deployed, repositioning and retrieval of the valve is not possible. Attempted retrieval (e.g., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage.
  • Valve recipients should be maintained on antiplatelet and/or anticoagulant therapy post procedure, per institutional standards and established guidelines, except when contraindicated, using individualized treatment as determined by their physician.
  • Post-implant monitoring and/or possible electrophysiology evaluation may be considered in patients with transient high degree or complete AV block or other conduction disturbances during or following implantation of the valve. This may include continuous ECG monitoring after hospital discharge.

Adverse events potentially associated with the use of transcatheter bioprosthetic heart valves include but are not limited to:

  • access site complications (e.g., pain, bleeding, infection, hematoma, pseudoaneurysm, etc.)
  • acute coronary obstruction
  • acute myocardial infarction
  • allergic reaction to antiplatelet agents, contrast medium, or valve components
  • aortic rupture
  • ascending aorta trauma
  • atrio-ventricular node block
  • cardiac arrhythmias
  • conduction system injury
  • conversion to open surgical procedure
  • death
  • dissection
  • embolism
  • emergent balloon valvuloplasty
  • emergent percutaneous coronary intervention (PCI)
  • emergent surgery (i.e., coronary artery bypass, heart valve replacement)
  • endocarditis
  • explantation
  • heart failure
  • hemodynamic compromise
  • hemolysis
  • hemolytic anemia
  • hemorrhage
  • hypotension or hypertension
  • infection
  • myocardial ischemia
  • mitral valve insufficiency
  • multi-organ failure
  • non-structural dysfunction (i.e., entrapment by pannus, paravalvular leak, inappropriate sizing or positioning)
  • pannus
  • pericardial effusion
  • perforation of the myocardium, ventricle, or a blood vessel
  • permanent disability
  • permanent pacemaker
  • regurgitation
  • renal insufficiency or renal failure
  • reoperation
  • respiratory failure
  • sepsis
  • stroke
  • structural deterioration (i.e., calcification, leaflet tear)
  • thrombosis
  • tamponade
  • transfusion
  • valve embolization or migration
  • vessel dissection or spasm