United States securities and exchange commission logo
June 22, 2021
Jurgi Camblong, Ph.D., M.B.A.
Chief Executive Officer
SOPHiA GENETICS SA
Rue du Centre 172
CH-1025 Saint-Sulpice
Switzerland
Re: SOPHiA GENETICS SA
Draft Registrant
Statement on Form F-1
Submitted May 24,
2021
CIK No. 0001840706
Dear Dr. Camblong:
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.
Draft Registrant Statement on Form F-1 submitted May 24, 2021
Prospectus Summary
Overview, page 1
1. We note your disclosure
in your prospectus summary that you "estimate the total
addressable market
opportunities in 2020 for [y]our current commercial clinical
applications and for
[y]our current biopharma applications were approximately $21 billion
and $14 billion,
respectively" and that you "estimate that [y]our clinical and biopharma
applications targeted a
$35 billion global total addressable market opportunity in 2020,
$14 billion of which
was in the United States." In addition, we note your statement that
you believe that your
SOPHiA platform "is one of the most widely used decentralized
Jurgi Camblong, Ph.D., M.B.A.
FirstName LastNameJurgi
SOPHiA GENETICS SA Camblong, Ph.D., M.B.A.
Comapany
June NameSOPHiA GENETICS SA
22, 2021
June 22,
Page 2 2021 Page 2
FirstName LastName
analytics platform globally for clinical genomics" and had $28.4
million in revenue for the
year ended December 31, 2020. Please reconcile these statements by
providing us the
basis for your total addressable market and disclose any material
assumptions and
limitations associated with your estimate of the total addressable
market.
2. We note that you highlight here that "[a]s of March 31, 2021, [you]
served more than 750
hospital, laboratory and biopharma customers globally." Please also
disclose the number
of recurring platform customers as of a recent date.
3. We note your disclosure on page 2 that you commercialize your SOPHiA
platform and
related solutions, products and services as RUO and CE-IVD products.
Please clarify here
that in the United States, SOPHiA products are labeled and sold for
research use only, and
not for the diagnosis or treatment of disease. In addition, with
reference to your disclosure
on pages 154 and 156 regarding the RUO and CE-IVD designations, please
briefly
explain here the limitations placed on RUO products and the process by
which your in
vitro devices received a CE mark.
Market and Industry Data, page 83
4. We note your statements regarding market data used in the prospectus,
including that the
sources of the information do not guarantee the accuracy or
completeness of the
information and that investors are cautioned "not to give undue
weight" to projections,
assumptions and estimates. Please revise these statements to eliminate
any implication
that investors are not entitled to rely on the information included in
your registration
statement.
Use of Proceeds, page 84
5. We note your disclosure on page 104 that you remain obligated to pay
your lender,
TriplePoint, a fee upon the completion of this offering. To the extent
the offering
proceeds will be used to pay this obligation, please disclose the fee
owed to TriplePoint
here.
Management's Discussion and Analysis of Financial Conditions and Results of
Operations
Results of Operations, page 101
6. We note the manufacturing, marketing and supply agreements
(collaboration agreements)
discussed on pages 145-147. If these had a material impact on your
results of operations
please revise to quantify the impact each period.
Cost of Revenue, page 102
7. Please revise to quantify each of the factors related to the increase
in costs of revenue for
2020, including the write-off associated with the loss of the large
customer.
Jurgi Camblong, Ph.D., M.B.A.
FirstName LastNameJurgi
SOPHiA GENETICS SA Camblong, Ph.D., M.B.A.
Comapany
June NameSOPHiA GENETICS SA
22, 2021
June 22,
Page 3 2021 Page 3
FirstName LastName
Research and Development Costs, page 102
8. We note you attribute the increase in research and development costs
in 2020 to several
factors, including the development of new products and applications,
expansion of your
SOPHiA platform s multimodal capabilities and EHR integration.
Please revise to
quantify and discuss each of the reasons and contributing factors for
the increase in
research and development costs.
Revenue, page 102
9. Please revise to separately discuss and quantify each of the factors
contributing to the
increase in SOPHiA platform revenue, including the amount attributable
to the access
model mix shift from dry lab to bundle access, growth in Alamut
license revenue and
ramp-up in your biopharma services revenue.
Business
Our SOPHiA Platform Architecture, page 121
10. Please clarify the meaning of scientific or technical terms the first
time they are used in
order to ensure that lay readers will understand the disclosure. For
example, please
briefly explain what you mean by an "Extract Transform Load engine."
Biopharma Applications, page 128
11. We note your disclosure that you began commercializing biopharma
applications in 2019.
Please provide additional disclosure here describing how your
biopharma applications are
being accepted in the biopharma market, including quantifying how many
customers have
used your biopharma applications.
High Visibility and Predictability into Our Business, page 138
12. We note your disclosure that, "[o]nce onboarded onto [y]our SOPHiA
platform, [y]our
customers tend to steadily increase their use of [y]our SOPHiA
platform." However, we
note your platform analysis volume by cohort excludes volume
contributions from your
integrated access customers due to the fact they are a "a small
percentage of [y]our overall
volume and utilize [y]our platform in an ad hoc manner." Please revise
your disclosure to
discuss how the integrated access model fits into your "land and
expand" growth strategy
or otherwise advise.
Platform Analysis Volume by Cohort - Steady "Land and Expand" Growth, page 138
13. We note your graphic on page 138 depicting annual platform analysis
volume of various
customer cohorts over time. Please revise the graphic to quantify the
annual platform
analysis volume for each cohort for each year shown.
Jurgi Camblong, Ph.D., M.B.A.
FirstName LastNameJurgi
SOPHiA GENETICS SA Camblong, Ph.D., M.B.A.
Comapany
June NameSOPHiA GENETICS SA
22, 2021
June 22,
Page 4 2021 Page 4
FirstName LastName
Biopharma Case Study, page 141
14. We note your disclosure regarding your support of your customer's
in-depth re-analysis of
its proprietary clinical trial data using a multimodal approach,
including your customer's
objective. Please add additional disclosure here discussing any
results or otherwise advise
if the project is still ongoing.
Patents, page 143
15. With respect to material patents, please describe the specific
products, product groups and
technologies to which such patents relate (e.g. SOPHiA DDM, Alamut,
etc.), the scope of
your most significant patents, the jurisdictions in which they were
issued, and when they
will expire. If you do not believe you hold any material patents,
please revise your
disclosure accordingly.
Normandie Valorisation-Exclusive License Agreements, page 144
16. Please revise your disclosure here to clarify the product(s) for which
you are required to
pay the per analysis fee under the license agreement.
Medical Device Regulatory Framework, page 150
17. Given your global footprint as referenced on page 140, please provide
a brief overview of
the regulatory framework for any additional material jurisdictions in
which you distribute
your products and describe any limitations on your ability to
commercialize your products
in that jurisdiction.
Principal Shareholders, page 177
18. Please revise footnote 2 to identify the natural persons who are the
beneficial owners of
the shares held by Generation IM Sustainable Solutions Fund III, L.P.
Notes to the Consolidated Financial Statements
25. Share-based Compensation, page F-38
19. We note from page F-41 that the weighted average fair value of options
granted in 2020
under the 2019 ISOP was $34.97 per share and from page F-39 that the
weighted average
exercise price of such options was $84.48 per share, which appears
more consistent with
the range of share prices of options granted in 2020 under this ISOP
of $87.29-$97.31 per
share (page F-40). Please explain the significant difference between
the aforementioned
weighted average fair value and weighted average exercise price. Once
you have an
estimated offering price or range, please explain to us the reasons
for any differences
between the recent valuations of your common stock leading up to the
initial public
offering and the estimated offering price.
Jurgi Camblong, Ph.D., M.B.A.
SOPHiA GENETICS SA
June 22, 2021
Page 5
General
20. Please 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.
You may contact Jenn Do at 202-551-3743 or Brian Cascio at 202-551-3676
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Jason Drory at 202-551-8342 or Irene Paik at 202-551-3676 with any other
questions.
Sincerely,
FirstName LastNameJurgi Camblong, Ph.D., M.B.A.
Division of
Corporation Finance
Comapany NameSOPHiA GENETICS SA
Office of Life
Sciences
June 22, 2021 Page 5
cc: Yasin Keshvargar, Esq.
FirstName LastName