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United States securities and exchange commission logo
July 28, 2020
Leslie Trigg
President and Chief Executive Officer
Outset Medical, Inc.
3952 Orchard Drive
San Jose, CA 95134
Re: Outset Medical,
Inc.
Draft Registration
Statement on Form S-1
Submitted July 1,
2020
CIK 0001484612
Dear Ms. Trigg:
We have reviewed your draft registration statement and have the
following comments. In
some of our comments, we may ask you to provide us with information so
we may better
understand your disclosure.
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 our comments apply 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 these
comments and your
amended draft registration statement or filed registration statement, we
may have additional
comments.
DRS Submitted July 1, 2020
Prospectus Summary
Overview, page 1
1. Please indicate when
the Tablo console initially received FDA clearance.
2. please revise page 2 to
disclose your obligation to perform post-market surveillance.
3. We note your belief
that the COVID-19 pandemic has driven an increase in demand for
the Tablo console.
Please revise to quantify this increase.
Our Market Opportunity, page 2
4. Please disclose any
material assumptions and limitations associated with your estimate of
Leslie Trigg
FirstName LastNameLeslie Trigg
Outset Medical, Inc.
Comapany
July NameOutset Medical, Inc.
28, 2020
July 28,
Page 2 2020 Page 2
FirstName LastName
the total addressable market for your Tablo console.
Implications of Being an Emerging Growth Company, page 6
5. Please supplementally provide us with copies of all written
communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to
do so on your behalf,
present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
not they retain copies of the communications
Risk Factors
We have significant customer concentration..., page 22
6. Please identify the customer that accounted for 11% of your revenue in
2019 and whether
the loss of the customer would have a significant impact on your
business. Please
consider factors in addition to the direct loss of revenue, such as
reputation harm.
Our ability to utilize our net operating loss carryforwards..., page 30
7. Please quantify your net operating loss carryforwards and research and
development
credits.
Market, industry and other data, page 65
8. We note your statement that neither you nor the underwriters have
verified any third party
information obtained from third party sources. Please revise to
clarify that you are not
disclaiming liability for information provided in your registration
statement.
Use of Proceeds, page 66
9. Please revise your disclosure to include the estimated amount of
proceeds you plan to
allocate for each of the uses identified in the third paragraph.
Factors Affecting Our Business, page 77
10. Please revise to discuss the effects, if any, that COVID-19 has had on
your business,
including, what management expects its future impact will be, how
management is
responding to evolving events, and how it is planning for
COVID-19-related uncertainties
going forward. For guidance, see CF Disclosure Guidance: Topics No. 9
and 9A.
Management's Discussion and Analysis of Financial Condition and Results of
Operations
Results of Operations
Comparison of the three Months Ended March 31, 2019 and 2020, page 82
11. Please quantify each of the factors you noted under the Revenue and
Cost of Revenue line
items that explains the increase and/or decrease from the current
period to the
respective prior period, as applicable. For instance, one of the
factors you noted that
attributed to the 148% increase in product revenues for the three
months ended March 31,
Leslie Trigg
FirstName LastNameLeslie Trigg
Outset Medical, Inc.
Comapany
July NameOutset Medical, Inc.
28, 2020
July 28,
Page 3 2020 Page 3
FirstName LastName
2020 compared to the three months ended March 31, 2019 was increased
sales of console
leasing revenue. Please quantify this increase and quantify each of
the other factors noted.
Critical Accounting Policies and Estimates
Common Stock Valuations, page 93
12. Once you have an estimated offering price, please provide us with an
analysis explaining
how you determined the fair value of the common stock underlying your
equity issuances
along with the reasons for any differences between recent valuations
of your common
stock leading up to your offering 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.
Business Overview, page 97
13. We note your statement on page 15 that your strategy is based on
certain assumptions
about the adoption by home dialysis patients. Please clarify whether
your strategy is
based on an assumption that third party payers will provide
reimbursement for the Tablo
equipment. If it is based on that assumption, please expand your
discussion to describe
the status of third party reimbursement for your products or competing
products.
Patents, page 126
14. Please revise to disclose the expected expiration dates for pending
patent applications and
the identification of all applicable jurisdictions where patents are
granted or patent
applications are pending.
15. To the extent that your license agreement with Oregon State University
relates to the
Tablo console, please disclose the material terms and file the
agreement as an exhibit to
the registration statement or, in the alternative, tell us why you are
not required to file this
agreement. See Item 601(b)(10) of Regulation S-K.
Tablo Console, page 127
16. Please expand your discussion to describe the material terms of your
agreement with
Tacna. Additionally, file the agreement or explain the basis for your
belief that you are
not substantially dependent on the agreement.
Business
Reimbursement in the clinic and home settings, page 137
17. Please revise your discussion to address the reimbursement of
acquiring a Tablo in a home
setting.
Notes to Financial Statements
2. Summary of Significant Accounting Policies
Leases, page F-11
Leslie Trigg
Outset Medical, Inc.
July 28, 2020
Page 4
18. Please tell us the accounting literature you are applying to account
for your lease
agreements. In this regard, you noted on page F-16 and F-49 that you
are currently
evaluating the impact of the adoption of Leases (Topic 842) on your
financial statements.
Revenue, page F-13
19. You note that product revenue consists primarily of sales of the Tablo
console and related
consumables, including the Tablo cartridge, used in treatment
delivery. You also state that
revenue from product sales is recognized at a point in time. However,
on page F-17, under
Performance Obligations, you noted that "...performance obligations
are expected to be
satisfied over the term of the individual sales arrangement, which
generally are twelve
months." Please clarify this apparent inconsistency. In addition:
Please clearly disclose your performance obligations, and
Tell us if the sale of your Tablo console is distinct from the
related
consumables, such as the Tablo cartridge, and the reasons that
support your
accounting. In addition, tell us if the service agreement is
distinct from the other
performance obligations. Refer to ASC 606-10-25-19 through 25-22.
In this regard,
include in your response if the Tablo cartridge is available from
entities other than
you or if any cartridge besides the Tablo cartridge can be used
in the Tablo console.
Refer also to examples in ASC 606-10-55.
3. Revenue from Contracts with Customers, page F-17
20. Regarding your contractual agreement which contains both lease and
non-lease elements,
please tell us your consideration of providing an accounting policy
for this type of
contract. In this regard, you noted "console leasing revenue" and
"services associated with
leased consoles" as factors attributing to the increase in revenues
from March 31, 2019 to
March 31, 2020.
Item 15. Recent Sales of Unregistered Securities, page II-3
21. Please revise your disclosure to name the persons or identify the
class of persons to whom
the securities were sold. Please see Item 701 of Regulation S-K.
You may contact Tracey Houser at 202-551-3736 or Sasha Parikh at
202-551-3627 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jeff Gabor at 202-551-1544 or Suzanne Hayes at 202-551-3675 with any
other questions.
FirstName LastNameLeslie Trigg Sincerely,
Comapany NameOutset Medical, Inc.
Division of
Corporation Finance
July 28, 2020 Page 4 Office of Life
Sciences
FirstName LastName