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UPLOAD Filing

Heartflow, Inc.
Date: April 28, 2025 · CIK: 0001464521 · Accession: 0000000000-25-004479

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

Date
April 28, 2025
Author
cc: Ryan Coombs, Esq.
Form
UPLOAD
Company
Heartflow, Inc.

Letter

Re: Heartflow, Inc. Amendment No. 2 to Draft Registration Statement on Form S-1 Submitted April 18, 2025 CIK No. 0001464521 Dear John C.M. Farquhar:

April 28, 2025

John C.M. Farquhar Chief Executive Officer Heartflow, Inc. 331 E. Evelyn Avenue Mountain View, CA 94041

We have reviewed your amended draft registration statement and have the following comments.

Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our April 10, 2025 letter.

Amendment No. 2 to Draft Registration Statement on Form S-1 Risk Factors We face risks associated with a concentrated customer base., page 23

1. We note your response to comment 5. Please revise to explain how "the decision- making function for some of [your] accounts is concentrated in a relatively small number of customers," and advise whether you expect new accounts to come from current or new customers going forward. Please also clarify how you determine an account is "new," given your disclosure that decision-making for accounts is concentrated in a relatively small number of customers. April 28, 2025 Page 2

Management's Discussion and Analysis of Financial Condition and Results of Operations Components of our results of operations, page 84

2. We note your revised disclosure that "new accounts generally take 12 months to reach steady state revenue case volumes." Please revise to clarify the case volumes you consider to be "steady state," and explain the significance of this fact to your business and operations. 3. You disclose that "[r]evenue cases generated from clinic or office-based accounts typically carry a lower pricing than hospital-based accounts, commensurate with their lower reimbursement levels," and that you "expect the percentage of [y]our revenue cases generated from clinic or office-based accounts to increase over time." You also disclose that your revenue has fluctuated, and you expect it to continue to fluctuate based on, among other things, changes in the mix of customer accounts. To provide context for investors regarding your pricing, revenue, and customer mix, please clarify the percentage of your installed base attributable to clinic or office-based accounts compared to hospital-based accounts for the financial periods presented in the filing. Results of operations, page 86

4. We note your revised analysis of revenue in response to comment 6. As requested, please quantify the impact the three factors discussed had on revenue for fiscal year 2024 as compared to fiscal year 2023. Refer to Item 303(b)(2) of Regulation S-K and Section 501.12.b.3. of the Financial Reporting Codification (i.e., Release 33-8350, Section III.B.3.) for guidance. 5. We note your disclosure on page 88 that "[t]he gross margin increase during the year ended December 31, 2024 was primarily driven by increased revenues and through the launch of a major new algorithm that significantly increased the automation of manual components of the production teams process, which lowered the cost of revenue per analysis." Please revise to briefly discuss the new algorithm. Further, as requested in comment 7, please quantify the impact the increase in revenue and the launch of a new algorithm had on the increase in gross margin for fiscal year 2024 compared to fiscal year 2023. Refer to Item 303(b)(2) of Regulation S-K and Section 501.12.b.3. of the Financial Reporting Codification (i.e., Release 33-8350, Section III.B.3.) for guidance. Liquidity and capital resources Sources of liquidity, page 89

6. We note in response to comment 8 that you intend to disclose your cash balance as of March 31, 2025. In addition, please expand your disclosures to provide investors with a discussion of the material factors that have impacted and will continue to impact your liquidity from a short-term and long-term perspective. Specifically, we note that as of December 31, 2024 in comparison to December 31, 2023, when you concluded that there was substantial doubt about your ability to continue as a going concern, your working capital has decreased, the degree to which total liabilities exceeds total assets has increased, total stockholders deficit has increased, you continue to recognize loss from operations and net loss, and that you expect to "continue to incur losses and expend significant amounts of cash in the foreseeable future." This April 28, 2025 Page 3

discussion should bridge the gap between these negative factors and your conclusion that your cash balance is sufficient to meet all of your cash obligations within the next 12 months and explain how you intend to address your ongoing liquidity needs over the long-term and the implications if you are unable to meet those long-term liquidity needs. Refer to Item 303(b)(1) of Regulation S-K and Section 501.13 of the Financial Reporting Codification (i.e., Release 33-8350, Section IV) for guidance. Business Our Heartflow FFRCT Analysis, page 120

7. We note your response to comment 9. Please tell us how the PRECISE trial supports your disclosure that NITs are inaccurate a majority of the time, and often result in either missed CAD diagnoses or unnecessary invasive procedures, and revise your disclosure accordingly. Please contact Tracey Houser at 202-551-3736 or Terence O'Brien at 202-551-3355 if you have questions regarding comments on the financial statements and related matters. Please contact Juan Grana at 202-551-6034 or Katherine Bagley at 202-551-2545 with any other questions.

Sincerely,
Division of
Corporation Finance
Office of
Industrial Applications and
Services
cc: Ryan Coombs, Esq.

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
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<FILENAME>filename2.txt
<TEXT>
 April 28, 2025

John C.M. Farquhar
Chief Executive Officer
Heartflow, Inc.
331 E. Evelyn Avenue
Mountain View, CA 94041

 Re: Heartflow, Inc.
 Amendment No. 2 to Draft Registration Statement on Form S-1
 Submitted April 18, 2025
 CIK No. 0001464521
Dear John C.M. Farquhar:

 We have reviewed your amended draft registration statement and have the
following
comments.

 Please respond to this letter by providing the requested information and
either
submitting an amended draft registration statement or publicly filing your
registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your
amended draft registration statement or filed registration statement, we may
have additional
comments. Unless we note otherwise, any references to prior comments are to
comments in
our April 10, 2025 letter.

Amendment No. 2 to Draft Registration Statement on Form S-1
Risk Factors
We face risks associated with a concentrated customer base., page 23

1. We note your response to comment 5. Please revise to explain how "the
decision-
 making function for some of [your] accounts is concentrated in a
relatively small
 number of customers," and advise whether you expect new accounts to come
from
 current or new customers going forward. Please also clarify how you
determine an
 account is "new," given your disclosure that decision-making for
accounts is
 concentrated in a relatively small number of customers.
 April 28, 2025
Page 2

Management's Discussion and Analysis of Financial Condition and Results of
Operations
Components of our results of operations, page 84

2. We note your revised disclosure that "new accounts generally take 12
months to reach
 steady state revenue case volumes." Please revise to clarify the case
volumes you
 consider to be "steady state," and explain the significance of this fact
to your business
 and operations.
3. You disclose that "[r]evenue cases generated from clinic or office-based
accounts
 typically carry a lower pricing than hospital-based accounts,
commensurate with their
 lower reimbursement levels," and that you "expect the percentage of
[y]our revenue
 cases generated from clinic or office-based accounts to increase over
time." You also
 disclose that your revenue has fluctuated, and you expect it to continue
to fluctuate
 based on, among other things, changes in the mix of customer accounts.
To provide
 context for investors regarding your pricing, revenue, and customer mix,
please clarify
 the percentage of your installed base attributable to clinic or
office-based accounts
 compared to hospital-based accounts for the financial periods presented
in the filing.
Results of operations, page 86

4. We note your revised analysis of revenue in response to comment 6. As
requested,
 please quantify the impact the three factors discussed had on revenue
for fiscal year
 2024 as compared to fiscal year 2023. Refer to Item 303(b)(2) of
Regulation S-K and
 Section 501.12.b.3. of the Financial Reporting Codification (i.e.,
Release 33-8350,
 Section III.B.3.) for guidance.
5. We note your disclosure on page 88 that "[t]he gross margin increase
during the year
 ended December 31, 2024 was primarily driven by increased revenues and
through
 the launch of a major new algorithm that significantly increased the
automation of
 manual components of the production teams process, which lowered the
cost of
 revenue per analysis." Please revise to briefly discuss the new
algorithm. Further, as
 requested in comment 7, please quantify the impact the increase in
revenue and the
 launch of a new algorithm had on the increase in gross margin for fiscal
year 2024
 compared to fiscal year 2023. Refer to Item 303(b)(2) of Regulation S-K
and Section
 501.12.b.3. of the Financial Reporting Codification (i.e., Release
33-8350, Section
 III.B.3.) for guidance.
Liquidity and capital resources
Sources of liquidity, page 89

6. We note in response to comment 8 that you intend to disclose your cash
balance as of
 March 31, 2025. In addition, please expand your disclosures to provide
investors with
 a discussion of the material factors that have impacted and will
continue to impact
 your liquidity from a short-term and long-term perspective.
Specifically, we note that
 as of December 31, 2024 in comparison to December 31, 2023, when you
concluded
 that there was substantial doubt about your ability to continue as a
going concern,
 your working capital has decreased, the degree to which total
liabilities exceeds total
 assets has increased, total stockholders deficit has increased, you
continue to
 recognize loss from operations and net loss, and that you expect to
"continue to incur
 losses and expend significant amounts of cash in the foreseeable
future." This
 April 28, 2025
Page 3

 discussion should bridge the gap between these negative factors and your
conclusion
 that your cash balance is sufficient to meet all of your cash
obligations within the next
 12 months and explain how you intend to address your ongoing liquidity
needs over
 the long-term and the implications if you are unable to meet those
long-term liquidity
 needs. Refer to Item 303(b)(1) of Regulation S-K and Section 501.13 of
the Financial
 Reporting Codification (i.e., Release 33-8350, Section IV) for guidance.
Business
Our Heartflow FFRCT Analysis, page 120

7. We note your response to comment 9. Please tell us how the PRECISE trial
supports
 your disclosure that NITs are inaccurate a majority of the time, and
often result in
 either missed CAD diagnoses or unnecessary invasive procedures, and
revise your
 disclosure accordingly.
 Please contact Tracey Houser at 202-551-3736 or Terence O'Brien at
202-551-3355 if
you have questions regarding comments on the financial statements and related
matters. Please contact Juan Grana at 202-551-6034 or Katherine Bagley at
202-551-2545
with any other questions.

 Sincerely,

 Division of
Corporation Finance
 Office of
Industrial Applications and
 Services
cc: Ryan Coombs, Esq.
</TEXT>
</DOCUMENT>