Form 8-K

8-K — Heartflow, Inc.

Accession: 0001464521-26-000069

Filed: 2026-05-14

Period: 2026-05-14

CIK: 0001464521

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — htfl-20260514x8k.htm (Primary)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

______________________

FORM 8-K

______________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 14, 2026

______________________

Heartflow, Inc.

(Exact name of Registrant as Specified in Its Charter)

______________________

Delaware

001-42790

26-0506743

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

135 Main Street, Suite 1000

San Francisco, California 94105

(Address of Principal Executive Offices) (Zip Code)

(650) 241-1221

(Registrant’s Telephone Number, Including Area Code)

331 E. Evelyn Avenue, Mountain View, CA 94041

(Former Name or Former Address, if Changed Since Last Report)

______________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

HTFL

The Nasdaq Stock Market LLC

(Nasdaq Global Select Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 2.02 Results of Operations and Financial Condition.

On May 14, 2026, Heartflow, Inc. issued a press release regarding its financial results for the quarter ended March 31, 2026. A copy of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits.

Exhibit No.

Description

99.1

Press Release of Heartflow, Inc. issued on May 14, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

The information contained in Items 2.02 and 9.01 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

‎

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

HEARTFLOW, INC.

Date: May 14, 2026

By:

/s/ Vikram Verghese

Vikram Verghese

Chief Financial Officer

EX-99.1

Filename: htfl-20260514xex99_1.htm · Sequence: 2

Exhibit 99.1 2026.05.14

Exhibit 99.1

Heartflow Reports First Quarter 2026 Financial Results and Raises Full Year 2026 Guidance

SAN FRANCISCO — May 14, 2026 – Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today reported financial results for the first quarter ended March 31, 2026.

First Quarter 2026 Highlights

Total revenue of $52.6 million, a 41% increase year-over-year

Gross margin of 80.2%, non-GAAP gross margin of 80.5%

Net operating loss of $29.5 million, including a $7.5 million non-cash impairment charge associated with facilities optimization and headquarters relocation to San Francisco. Non-GAAP net operating loss was $15.5 million

2026 Annual Guidance

Total revenue of $228 million to $232 million (approximately 29% to 32% growth year-over-year), compared to previous guidance of $218 million to $222 million (approximately 24% to 26% growth year-over-year)

Non-GAAP gross margin of approximately 81%, compared to previous guidance of 80% to 81%

“Heartflow entered 2026 with unprecedented momentum, expanding the category leadership we established over the last several years,” said John Farquhar, President and CEO of Heartflow. “Our AI-driven platform, deeply embedded commercial footprint, and the world’s largest database that recently expanded to over 200 million annotated CCTA images combine to create a foundational advantage that grows stronger with every quarter. The growth of our core FFRCT business remains durable, and adoption of Heartflow Plaque Analysis is ramping ahead of schedule. Most importantly, by helping physicians guide the care of over 650,000 patients worldwide, Heartflow has achieved an unrivaled scale of real-world experience. As the architects of this category, we continue to extend our leadership position, becoming the AI operating system of record for the detection, diagnosis, management, and treatment planning of coronary artery disease.”

First Quarter 2026 Financial Results

Total revenue was $52.6 million, a 41% increase year-over-year. U.S. revenue was $48.3 million, a 42% increase year-over-year. International and other revenue was $4.3 million, a 34% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT volume.

Gross profit was $42.2 million, compared to $27.9 million in the prior year period. Non-GAAP gross profit was $42.3 million, compared to $28.0 million in the prior year period.

Gross margin was 80.2%, compared to 75.1% in the prior year period. Non-GAAP gross margin was 80.5%, compared to 75.3% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in revenue case volume and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel.

Total operating expenses were $71.7 million, or 136% of total revenue, compared to $45.4 million, or 122% of total revenue, in the prior year period. GAAP operating expenses also included a $7.5 million non-cash impairment charge related to the right-of-use asset for our Mountain View, California facility. The Company optimized its facilities footprint and relocated its headquarters to San Francisco. Non-GAAP total operating expenses were $57.8 million, or 110% of total revenue, compared to $43.0 million, or 116% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research.

Net operating loss was $29.5 million, compared to $17.5 million in the prior year period. Non-GAAP net operating loss was $15.5 million, compared to $15.0 million in the prior year period.

Net loss was $27.4 million, or ($0.32) net loss per share, compared to $32.3 million, or ($5.25) net loss per share, in the prior year period. Non-GAAP net loss was $13.3 million, or ($0.16) non-GAAP net loss per share, compared to $19.2 million, or ($3.11) non-GAAP net loss per share, in the prior year period.

Adjusted EBITDA was ($14.0) million, compared to ($13.6) million in the prior year period.

Cash, cash equivalents and investments totaled $254.9 million as of March 31, 2026.

For additional information regarding non-GAAP financial measures, see “Use of Non-GAAP Measures,” “Heartflow GAAP to Non-GAAP Reconciliations” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below.

Webcast and Conference Call Details

Heartflow will host a conference call today, May 14, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its first quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com/. The archived version will be available for 12 months following completion of the live call.

About Heartflow’s Technology and Research

Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for nearly 650,000 patients worldwide.1 Key benefits include:

Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.

Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world

_________________________

1 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol

evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.

Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.

Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001.

About Heartflow, Inc.

Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com.

Use of Non-GAAP Measures

To supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the “Non-GAAP Measures”) in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure and, in the case of non-GAAP total operating expenses, non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share, basic and diluted, and an asset impairment charge. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company’s underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company’s underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company’s ongoing operations. Because of the variety of equity awards used by companies, the varying methodologies for determining stock-based compensation expense, the subjective assumptions used in those determinations, and the volatility in valuations that can be driven by market conditions outside the Company’s control, we believe excluding stock-based compensation expense enhances the ability of management and investors to understand and assess the underlying performance of our business over time and compare it against our peers, a majority of whom also exclude stock-based compensation expense from their non-GAAP results. With respect to the presentation of Adjusted EBITDA, the Company believes it is a useful measure to evaluate the Company’s operating performance and it is used by the Company to evaluate ongoing operations and for planning and forecasting purposes. Adjusted EBITDA is also

_________________________

2 Narula, et al. E HJ CVI 2024

3 Danad, et al. JAMA Cardiol 2017

4 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)

5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years)

a measure frequently used by analysts, investors and other interested parties to evaluate companies in our same industry.

The Company’s definition of the Non-GAAP Measures may differ from similarly titled measures used by others. The Non-GAAP Measures should be considered only as a supplement to, and not as a substitute for, or superior to, their most directly comparable GAAP financial measures. Because the Non-GAAP Measures exclude the effect of items that increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the reconciliations to the most comparable GAAP financial measures at the end of this press release and, when they become available, the Company’s consolidated financial statements and publicly filed Securities and Exchange Commission (“SEC”) reports in their entirety.

The Company is not able to provide a reconciliation without unreasonable efforts of its forward-looking guidance related to non-GAAP gross margin to the most directly comparable GAAP financial measure due to the unknown effect of stock-based compensation that is material to the comparable GAAP financial measure.

Forward-Looking Statements

This press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, expected market growth and financial guidance, are forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements, including, but not limited to: we may not be able to achieve or sustain profitability; our dependence on the success of our one product, Heartflow FFRCT Analysis; healthcare providers may be unwilling to change their standard practice regarding the evaluation of coronary artery disease; adoption of the Heartflow Platform by healthcare providers may be negatively impacted if third-party payors, including government payors, do not cover or provide adequate reimbursement; the concentration of our customer base; the significant competition we face in an environment of rapid technological change; the commercialization of Heartflow Plaque Analysis is nascent; risks associated with our use and development of AI models; risks related to failing to properly manage our future growth; disruption by catastrophic events; risks associated with our dependence on our information technology systems; security breaches that we cannot anticipate or successfully defend; extensive regulatory requirements we face to bring our products to market; and third parties could develop and commercialize technology and products similar or identical to ours. For a more extensive description of these and other risks and uncertainties that could materially affect our results, you should read our filings with the SEC, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as such filings may be amended, supplemented or superseded from time to time by other reports Heartflow files with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and we undertake no obligation to update the forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Investor Contact

Nick Laudico

nlaudico@heartflow.com

Media Contact

Elliot Levy

elevy@heartflow.com

Heartflow, Inc.

Consolidated Statements of Operations

(unaudited, in thousands, except share and per share data)

Three Months Ended

March 31,

2026

2025

Revenue

52,587

37,205

Cost of revenue

10,423

9,264

Gross profit

42,164

27,941

Operating Expenses:

Research and development

21,620

13,924

Selling, general and administrative

42,566

31,519

Asset impairment charge

7,482

Total operating expenses

71,668

45,443

Loss from operations

(29,504)

(17,502)

Interest income

2,464

543

Interest expense

(3)

(5,093)

Change in fair value of common stock warrant liability

(1,606)

Change in fair value of derivative liability

(9,045)

Other income (expense), net

(314)

358

Loss before provision for income taxes

(27,357)

(32,345)

Provision for income taxes

(23)

Net loss

(27,380)

(32,345)

Comprehensive loss:

Net loss

(27,380)

(32,345)

Other comprehensive loss:

Foreign currency translation gain (loss)

262

(236)

Unrealized loss on investments, net

(522)

Total other comprehensive loss

(260)

(236)

Total comprehensive loss

(27,640)

(32,581)

Net loss per share, basic and diluted

(0.32)

(5.25)

Weighted-average shares used to compute net loss per share, basic and diluted

85,639,675

6,164,617

Heartflow, Inc.

Consolidated Balance Sheets

(unaudited, in thousands)

March 31,

December 31,

2026

2025

Assets

Current assets

Cash and cash equivalents

19,671

44,776

Short-term investments

138,645

132,010

Accounts receivable, net

35,527

29,343

Prepaid expenses and other current assets

17,987

14,075

Total current assets

211,830

220,204

Long-term investments

96,582

103,365

Property and equipment, net

9,829

8,587

Operating lease right-of-use assets

14,407

17,488

Restricted cash, non-current

4,702

4,709

Other non-current assets

6,675

5,099

Total assets

344,025

359,452

Liabilities and stockholders' equity

Current liabilities

Accounts payable

5,750

3,169

Accrued expenses and other current liabilities

25,886

33,279

Operating lease liabilities, current portion

6,382

5,922

Total current liabilities

38,018

42,370

Operating lease liabilities, non-current portion

19,967

16,132

Other non-current liabilities

322

303

Total liabilities

58,307

58,805

Stockholders’ equity

Preferred stock, $0.001 par value

Common stock, $0.001 par value

Additional paid-in capital

1,401,447

1,388,737

Accumulated other comprehensive loss

(685)

(425)

Accumulated deficit

(1,115,130)

(1,087,750)

Total stockholders’ equity

285,718

300,647

Total liabilities and stockholders’ equity

344,025

359,452

Heartflow, Inc.

GAAP to Non-GAAP Reconciliations

(unaudited, in thousands except per share amounts and percentage data)

Three Months Ended March 31, 2026

Three Months Ended March 31, 2025

GAAP

Adjustments

Non-GAAP

GAAP

Adjustments

Non-GAAP

Gross profit

42,164

166

(a)

42,330

27,941

(a)

27,998

Gross margin

80.2%

0.3%

80.5%

75.1%

0.2%

75.3%

Operating Expenses:

Research and development

21,620

(2,137)

(a)

19,483

13,924

(547)

(a)

13,377

Selling, general and administrative

42,566

(4,251)

(a)

38,315

31,519

(1,888)

(a)

29,631

Asset impairment charge

7,482

(7,482)

Total operating expenses

71,668

(13,870)

57,798

45,443

(2,435)

43,008

Loss from operations

(29,504)

14,036

(15,468)

(17,502)

2,492

(15,010)

Net loss

(27,380)

14,036

(b)

(13,344)

(32,345)

13,143

(c)

(19,202)

Net loss per share, basic and diluted

(0.32)

0.16

(0.16)

(5.25)

2.14

(3.11)

(a)Represents adjustments related to stock-based compensation expense

(b)Represents adjustments for: (i) stock-based compensation expense of $6.5 million; and (ii) asset impairment charge of $7.5 million

(c)Represents adjustments for: (i) stock-based compensation expense of $2.5 million; (ii) change in fair value of common stock warrant liability of $1.6 million; and (iii) change in fair value of derivative liability of $9.0 million

Heartflow, Inc.

Reconciliation of GAAP Net Loss to Adjusted EBITDA

(unaudited, in thousands)

Three Months Ended

March 31,

2026

2025

GAAP net loss

(27,380)

(32,345)

Non-GAAP adjustments:

Interest (income) expense, net

(2,461)

4,550

Asset impairment charge

7,482

Change in fair value of common stock warrant liability

1,606

Change in fair value of derivative liability

9,045

Other (income) expense, net

314

(358)

Provision for income taxes

Depreciation and amortization

1,423

1,372

Stock-based compensation expense

6,554

2,492

Adjusted EBITDA

(14,045)

(13,638)

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

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Local phone number for entity.

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No definition available.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

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-Section 12

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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