SEC Comment Letter 0000000000-24-008227 to Omada Health, Inc. (OMDA)
Omada Health, Inc.
Date: July 22, 2024 · CIK: 0001611115 · Accession: 0000000000-24-008227
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July 21, 2024
Sean Duffy
Chief Executive Officer
Omada Health, Inc.
500 Sansome Street, Suite 200
San Francisco, CA 94111
Re:Omada Health, Inc.
Draft Registration Statement on Form S-1
Submitted June 24, 2024
CIK No. 0001611115
Dear Sean Duffy:
We have reviewed your 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.
Draft Registration Statement on Form S-1
Co-founder and CEO Letter, page i
1.We note that you include a member testimonial in the letter to investors on page iii. If you
continue to retain this customer feedback in the prospectus, please expand to provide
information regarding the context in which the assessment was made, including that this
testimonial was not solicited and that the member was not compensated.
Prospectus Summary, page 1
2.Please balance your summary disclosures by including a discussion of your accumulated
deficit. Please also expand your discussion of your net losses for the years ended
December 31, 2023 and 2022 to briefly discuss your costs and operating expenses.
We note your disclosure that you sell your programs to customers that cover the cost for
covered individuals. You also disclose on page F-14 that your customers are entities that
have contracted with the Company, or through a channel partner of the Company, to offer 3.
July 21, 2024
Page 2
one or more Omada virtual care programs and that the combination of the member,
employer, and, in certain cases, an additional party providing insurance coverage
represents the Company’s customer. Please revise to briefly describe how you generate
revenues for your services and products.
Our Market Opportunity, page 3
4.We note your disclosure regarding your addressable markets for prediabetes, diabetes,
hypertension, MSK and Medicare Advantage. Please revise to define "near-term,"
disclose the number of the target population and prevalence estimates for each, as well as
your average monthly list price per active member. Please also revise to disclose the
source of the data and explain the basis for any assumptions underlying your estimates.
For example, we note your disclosure on page 116 that the "estimates assume that
prevalence rates do not vary by geography or across age groups, with the exception of
diabetes" and that you have assumed that you "could capture the entirety of the population
with these conditions for purposes of these estimates."
5.You disclose that your target population comprises individuals covered by commercial
health insurance. Please clarify whether all commercial health insurance covers your
products and services.
Our Solution, page 4
6.We note the disclosure that your Care Teams are composed of health coaches, relevant
specialists, and licensed physical therapists. Please revise to clarify, if true, that while you
provide healthcare services, you do not currently provide medical physician services. We
note your disclosure on page 56.
7.You state that you are "validated by experts" and that you have received full recognition
from the CDC’s Diabetes Prevention Recognition Program for certain deployments of our
Omada for Prevention & Weight Health program. Please revise to explain the distinction
of full recognition by the CDC and clarify whether you have received accreditations for
all your products and services.
Non-GAAP Financial Measures, page 14
8.In the narratives you discussed and defined non-GAAP net losses excluding the impact of
items including interest expense, interest income, etc. However, in the table below you
presented non-GAAP operating loss, and provided the reconciliation for non-GAAP
operating loss at page 95. Please revise to be consistent.
Potential members' failure to enroll after a customer or channel partner enters into an agreement
with us could materially ..., page 23
Please revise to briefly explain why covered individuals may "fail to ultimately enroll at
the expected volume" in some cases. Please also further discuss the assumptions you rely
on to anticipate expected growth for your business and revenue.
9.
July 21, 2024
Page 3
If we fail to attract and retain senior leadership and key clinical, scientific, and technology
employees and other service providers ..., page 31
10.Please revise to discuss the risk to investors from Messrs. Shao and Cook being able to
terminate their employment contracts without notice or cause. We note your disclosure on
page 173 that "Mr. Cook’s employment pursuant to the offer letter is “at-will” and is
terminable by either party with or without notice or cause" and your disclosure on page
174 that "Mr. Shao’s employment pursuant to the offer letter is “at-will” and is terminable
by either party with or without notice or cause."
If the licensed physical therapists who provide services to our members are characterized as
employees, our business, financial condition..., page 36
11.We note the disclosure that you enter into agreements with a professional corporation,
Physera Physical Therapy Group, PC (“PPTG”), which enters into contracts with licensed
physical therapists pursuant to which they render professional services to your members.
We further note disclosure on page F-8 stating that for the purpose of the consolidated
financial statements, PPTG was determined to be a variable interest entity for which
Omada is the primary beneficiary. Please revise this risk factor or include a separate risk
factor to disclose that PPTG is treated as a VIE and address any material risks stemming
from this accounting treatment.
Provisions in our charter documents and under Delaware law could discourage a takeover that
stockholders may consider favorable and may lead, page 63
12.We note the disclosure that the board of director's discretion to issue shares of preferred
stock in the future could be used to significantly dilute the ownership of a hostile acquiror.
Please revise to also disclose how future issuances or conversion of your preferred stock
may be dilutive to your common stockholders.
Our amended and restated certificate of incorporation and amended and restated bylaws will
provide that the Court of Chancery ..., page 65
13.We note your disclosure that the forum selection provision in your amended and restated
certificate of incorporation may have the effect of discouraging lawsuits against you and
your directors, officers or other employees. Please revise this risk factor to disclose that
there is also a risk that your forum selection provision may result in increased costs for
investors to bring a claim.
Management's Discussion And Analysis Of Financial Condition And Results Of Operations
Key Components of Results of Operations, page 87
14.We note your disclosure that your "latest pricing models for cardiometabolic programs are
based on the respective member’s level of activity during the member’s service period."
Please revise to clarify if a member's level of activity is measured monthly or annually,
and to explain how activity is assessed. Please also briefly discuss why the price
for Omada for Diabetes and Omada for Hypertension is generally higher than the price for
Omada for Prevention & Weight Health.
July 21, 2024
Page 4
Management's Discussion and Analysis of Financial Condition and Results of Operations
Comparison of the Years Ended December 31, 2022 and 2023
Revenue, page 92
15.Revise to provide a more substantial discussion of the underlying drivers of the increase
in revenue from fiscal 2022 to fiscal 2023. For example, discuss what contributed to the
increase in total members, including impacts from new members and existing member
retention; in that regard, we note you discussed Net Dollar Retention Rate elsewhere in
the filing. Also elaborate to discuss fluctuations or impact from different programs, as
well as any known trend and uncertainties. See Item 303 of Regulation S-K.
Critical Accounting Policies, Estimates and Assumptions
Common Stock Valuations, page 102
16.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances, and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features. Please discuss with the staff how to submit your response.
Business, page 106
17.We note your disclosure that in 2023, your average customer satisfaction rate for the year
was over 90%. We also note your disclosure that in 2023, more than 55% of your
members still engaged with your cardiometabolic programs at least once per month after a
year in the program, and over 50% still engaged monthly after two years. Please revise to
disclose the source of these metrics and describe how the metrics were calculated. To
provide additional context for your disclosure, please also discuss how these rates
compare to your competitors.
Our Market Opportunity, page 115
18.We note that you make various statements throughout the registration statement regarding
developments in the healthcare industry and the efficacy of your programs. For example,
we note your disclosure on page 115 that "[m]embers who took GLP-1s and were
meaningfully engaged in an Omada program lost on average 1.7 times the weight at 12
months when compared to members who were less engaged in the program." We also
note your disclosure on page 116 that "[d]espite much effort over the last two decades,
there has been little improvement in diabetes outcomes" and on page 128 that "GLP-1s
represent a significant cost to medical budgets but are proven to result in significant
clinical outcomes, often making the decision to include coverage for GLP-1 therapies a
difficult one." Please revise to provide support for these statements.
The Omada Care Approach, page 116
We note your disclosure on page 118 that "[e]ach Omada health coach also obtains
certification as a Diabetes Prevention Program Lifestyle Coach" and that "[a]ll Omada
cardiometabolic specialists are Certified Diabetes Care and Education Specialists." Please
revise to discuss the significance of these certifications and note the organization 19.
July 21, 2024
Page 5
providing the certification. Please also discuss the additional training received by health
coaches in your hypertension program. We also note your disclosure on page 121 that
"[u]pon enrollment, [you] match health coaches to members based on key indicators of
their needs, then assign a Care Team depending on the program and context." Please
expand your disclosure to discuss these key indicators and the matching process.
20.We note your disclosure on page 124 that you have developed your own ML algorithms,
informed by data from your member interactions and information from your content
libraries, to "create a content recommendation engine that can use predictive insights to
present members with relevant wellness content and resources based on circumstances
and factors that [y]our clinical teams believe are likely to make those resources most
relevant." Please revise to discuss whether your ML algorithms rely on identifiable user
data or whether the data is randomized. Please also expand your discussion regarding how
you evaluate your members' form in performing certain exercises or motions, including
whether you have conducted any assessments regarding potential downsides from virtual
physical therapy sessions.
Clinical Leadership, page 131
21.Please revise your disclosure regarding your peer-reviewed studies to disclose the date of
the studies, the organization that conducted each of the studies, how participants in the
studies were selected, and any material assumptions and adverse findings, if any,
underlying the summary outcomes.
22.We note your disclosure on page 134 that you have utilized a simulation model, created
by GlobalData, to provide projected cost savings estimates up to five years. Please revise
to discuss the assumptions underlying this simulation model and the projected savings.
Case Studies, page 141
23.We note your presentation of "case studies" in this section. Please revise to explain how
the case studies are representative of your customers, how you identified the parties you
are highlighting in the case studies and whether the results highlighted in the case
studies are representative of your customers during the same time periods presented.
Competition, page 155
24.We note your disclosure that you currently face competition "from a range of digital
health companies, including DarioHealth Corp., Hello Heart Inc., Hinge Health, Inc., Lark
Technologies, Inc., Livongo (via Teladoc Health, Inc.), Onduo LLC, SWORD Health,
Inc., Vida Health, Inc., and Virta Health Corp." Please revise to discuss how you
compare to these competitors. Please also clarify which of these competitors offers
cardiometabolic and MSK digital healthcare programs.
Intellectual Property, page 156
25.We note your disclosure that "[i]n the aggregate, [y]our intellectual property assets are of
material importance to [y]our business; however, [you] believe that no single patent,
technology, trademark, intellectual property asset, or license is material in relation to any
segment of [y]our business as a whole." Please revise to disclose whether any of your
issued patents will expire in the near-term.
July 21, 2024
Page 6
Regulatory Environment, page 156
26.Please revise this section to discuss your current state of compliance with each of the
regulatory requirements discussed. In particular, please explain, as discussed elsewhere in
the registration statement, whether your products are subject to regulation by the FDA.
Executive Compensation, page 170
27.Please revise the 2023 summary compensation table to include a separate column for
bonuses and stock awards. Refer to Item 402(c) of Regulation S-K.
Description of Capital Stock, page 185
28.Please revise to describe the terms of the Series A, Series B, Series C, Series C-1, Series
D, Series D-1, and Series E preferred stock in this section of your prospectus. Please also
describe the terms of your outstanding warrants. We note your disclosures on pages F-28
and F-31.
Notes to Consolidated Financial Statements
2. Summary of Significant Accounting Policies
Revenue Recognition, page F-14
29.Please address the following comments related to your revenue recognition:
•Disclose your arrangements with different type of customers, including but not
limited to health plans and PBMs who are your direct customers or acting as channel
partners reselling your programs to their own end customers. In that regard, you
disclosed that as of December 31, 2023, customers accessing your programs via a
channel partner represented more than 85% of your customer base.
•Disclose your revenue recognition accounting policies for each type of customer.
Specifically disclose what method service revenue is recognized over time during the
non-cancelable term as access to the program is provided.
•Disclose the type and amount of variable considerations impacting revenue and any
significant change in estimate in accordance with ASC 606-10-50-12. In that regard,
we note your disclosures include performance guarantees and an innovative approach
to pricing on page 138, and that some fees are subject to repayment at page 33.
•Explain to us how you have considered ASC