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United States securities and exchange commission logo
June 13, 2021
Ron Kurtz, M.D.
President and Chief Executive Officer
RxSight, Inc.
100 Columbia
Aliso Viejo, CA 92656
Re: RxSight, Inc.
Draft Registration
Statement on Form S-1
Submitted May 17,
2021
CIK No. 0001111485
Dear Dr. Kurtz:
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 Registration Statement on Form S-1 filed May 17, 2021
Prospectus Summary
Overview, page 1
1. We note your disclosure
here and in the Business section regarding head-to-
head comparisons
between your RxSight system and "the two most widely adopted
alternative premium
IOLs." If you have not conducted actual head-to-head trials, please
revise your disclosure
to clearly state this fact and disclose why you believe these
comparisons are
appropriate. If you provide disclosure regarding results from other trials,
expand your disclosure
to provide additional information regarding these trials that would
help an investor make a
meaningful comparison (e.g., number of subjects, trial design,
statistical
significance, etc.).
Ron Kurtz, M.D.
FirstName LastNameRon Kurtz, M.D.
RxSight, Inc.
Comapany
June NameRxSight, Inc.
13, 2021
June 13,
Page 2 2021 Page 2
FirstName LastName
Our success factors, page 3
2. We note your disclosure here that one of your differentiating success
factors is that you
offer an, "attractive value proposition that is readily understood by
doctors and other
providers." However, we note your disclosure elsewhere, including your
risk factor
disclosure on page 23 where you state that "[doctors] must make a
significant up-
front investment to purchase the LDD" and your disclosure on page 5
that, "44% of
surgeons and 36% of surgeons reported factors that discourage them
from offering
premium IOLs due to concern over nighttime vision and loss of contrast
sensitivity,
respectively." Please revise your statement or otherwise advise.
Our solution, page 5
3. We note your statement that you designed your RxSight system to
"provide a single IOL
that can address the broadest range of patient types and needs."
Please balance this
statement with disclosure that your RxSight system is approved for
"adult patients
with pre-existing corneal astigmatism of => 0.75 diopters and without
pre-
existing macular disease," and clarify whether your product can
address the entire
population of patients who are currently eligible for conventional
cataract surgery.
Market, industry and other data, page 88
4. Your statements that (i) you have not independently verified any of
the data from third
party sources and (ii) investors are cautioned not to give undue
weight to your internal
research may imply an inappropriate disclaimer of responsibility with
respect to such
information. Please either delete these statements or specifically
state that you are liable
for such information.
Use of proceeds, page 89
5. We note that you intend to use proceeds to expand your sales force and
customer support
and operations, increase your research and development activities,
conduct or sponsor
clinical studies and trials, expand internationally, and provide for
working capital and
other general corporate purposes. Please revise to disclose the
approximate amount to be
used for each such purpose. Refer to Item 504 of Regulation S-K. In
addition, please
revise to clarify whether any material part of the proceeds is to be
used to discharge
indebtedness. If so, please provide the disclosure required by
Instruction 4 to Item 504 of
Regulation S-K.
Key business metrics, page 102
6. We note your statement that you "believe the number of LALs sold
(reported as implanted
in a patient) in each quarter is an important metric indicative of
adoption and utilization of
our RxSight system." In addition, we note that your table at the
bottom of page 102
appears to indicate that your LLD installed base increased
significantly from Q3 2020 to
Q1 2021 from 69 to 105 LDD installed; however, your LALs sold in the
quarter appeared
Ron Kurtz, M.D.
FirstName LastNameRon Kurtz, M.D.
RxSight, Inc.
Comapany
June NameRxSight, Inc.
13, 2021
June 13,
Page 3 2021 Page 3
FirstName LastName
to remain relatively flat at 1,513 LALs sold in Q3 2020 versus 1,567
LALs sold in Q1
2021. Please update your disclosure here to include sufficient
narrative disclosure to
provide appropriate context of your results.
Business
Overview, page 123
7. We note your disclosure here that you "anticipate future developments
may include
development of advanced presbyopia correction techniques and
commencement of a PMA
clinical trial in the United States for FDA approval of an EDOF IOL
indication" and your
disclosure on page 127 that "[m]any of the additional applications on
[y]our system would
simply require that [you] change the algorithm of [y]our LDD to shape
the light and the
LAL" and that you "have received fifteen supplemental approvals that
enable the RxSight
system to meet evolving customer needs." Please balance your
disclosure to clarify how
far along you are in researching and developing your technology for
additional
indications. For example, it is inappropriate to highlight that your
RxSight system can be
changed with simple algorithms if the features and functionality that
do not currently exist
in prototype form. In addition, please expand your disclosure to
provide greater detail on
the material "supplemental approvals that enable the RxSight system to
meet evolving
customer needs."
8. We note your disclosure that your RxSight system has received the CE
mark and
marketing approval in Mexico. Please update your disclosure to clearly
state the specific
indications your products are approved for under each regulatory
jurisdiction.
First and only commercially available IOL technology that allows customization
and
optimization of patient vision after surgery, page 124
9. We refer to your statement here that you believe you can, "deliver
future product
enhancements and expansion of indications for [y]our platform on a
rapid development
timeline." Please tell us why you believe a "rapid development" time
frame is realistic
given the lengthy and uncertain process of seeking regulatory
approval.
Investing in system enhancements to meet the evolving needs of doctors and
other providers as
well as patients, page 127
10. We note your statement that you "are currently developing a lower cost
version of the
LDD." Please add disclosure describing the regulatory approval process
you anticipate for
your lower cost LDD and provide additional details on where you are
currently at in the
research and development process or otherwise advise.
Astigmatism-Correcting or Toric Lenses, page 131
11. Please provide your basis for your statement that, "due to the limited
precision of existing
toric IOLs, only a fraction of patients with visually significant
astigmatism receive a lens
that corrects their astigmatism."
Ron Kurtz, M.D.
RxSight, Inc.
June 13, 2021
Page 4
Reduction in "Outliers", page 138
12. Please revise to indicate the basis for your disclosure in this
section. If your statements are
intended to convey superiority to the identified competitors'
products, please provide a
description of the head to head studies in the discussion of your
business. If there are no
head to head studies supporting your claims, please tell us why such
comparisons are
appropriate.
Sales and marketing, page 140
13. We note your disclosure that, "[y]our cumulative surveys compiled as
of Q1 2021
indicated 86.8% Strongly Agree, and 13.2% Agree that they
were satisfied with the
overall support and guidance provided by [you] during the product
integration period."
Please amend your disclosure to briefly describe the parameters of the
survey, including a
discussion of how you selected the participants, the number of
participants, and how you
determined that your survey results support the above-referenced
statement. In addition,
please revise to clarify whether the survey revealed any material
disadvantages concerning
your products.
Intellectual Property, page 145
14. Please revise to disclose the type of patent protection you have and
the expiration dates for
each of your material issued patents for each of your technologies.
For example, it is
unclear which patents cover your LDD, LAL and related devices and
methods.
15. We note your disclosure regarding your license agreement with CalTech,
including your
potential royalty obligation. However, we also note your disclosure
that you currently do
not sell any licensed products under the agreement. Please revise your
disclosure to clarify
if the license agreement covers potential material future products
currently under
development or otherwise advise.
Competition, page 146
16. We note your disclosure that you believe one of the principal
competitive factors in your
market is "patient experience, including recovery time and level of
discomfort." We
further note that your product requires UV blocking glasses to be worn
following surgery
until the LAL in locked in, which appears to typically be for a period
of several weeks
following surgery. Please add disclosure here or elsewhere in your draft
registration
describing how your patient experience compares with your material
competitors. Please
also advise what consideration you have given to including a risk factor
discussing that
FirstName LastNameRon Kurtz, M.D.
your RxSight system requires patients to wear protective glasses
following surgery until
Comapany NameRxSight,
the LAL Inc.the impact this requirement may have on the
ultimate market
is locked and
acceptance
June 13, 2021 Pagefor 4 the RxSight system.
FirstName LastName
Ron Kurtz, M.D.
FirstName LastNameRon Kurtz, M.D.
RxSight, Inc.
Comapany
June NameRxSight, Inc.
13, 2021
June 13,
Page 5 2021 Page 5
FirstName LastName
Exclusive jurisdiction, page 192
17. We note your disclosure here does not appear to be consistent with
your risk factor
disclosure on page 79. For example, your disclosure on page 79
indicates that nothing in
your amended and restated bylaws precludes stockholders that assert
claims under the
Securities Act or the Exchange Act from bringing such claims in state
or federal court,
subject to applicable law. Your disclosure here, however, indicates
that your amended and
restated certificate of incorporation will provide that the federal
district courts of the
United States of America will be the exclusive forum for resolving any
complaint
asserting a cause of action arising under the Securities Act. In
addition to correcting your
disclosure for this apparent inconsistency, please disclose whether
your various exclusive
forum provisions will apply to actions arising under the Securities
Act or Exchange Act.
In that regard, we note that Section 27 of the Exchange Act creates
exclusive federal
jurisdiction over all suits brought to enforce any duty or liability
created by the Exchange
Act or the rules and regulations thereunder, and Section 22 of the
Securities Act creates
concurrent jurisdiction for federal and state courts over all suits
brought to enforce any
duty or liability created by the Securities Act or the rules and
regulations thereunder. If the
provision applies to Securities Act claims, please also revise your
disclosure to state that
there is uncertainty as to whether a court would enforce such
provision and that investors
cannot waive compliance with the federal securities laws and the rules
and regulations
thereunder. If this provision does not apply to actions arising under
the Securities Act or
Exchange Act, please also ensure that the exclusive forum provision in
the governing
documents states this clearly, or tell us how you will inform
investors in future filings that
the provision does not apply to any actions arising under the
Securities Act or Exchange
Act.
Note 2 - Summary of accounting policies
Revenue recognition, page F-19
18. Please expand your disclosures to clarify when you are recognizing
revenue for each type
of performance obligation over time along with the method used or
point in time along
with when it occurs in the revenue cycle. Refer to ASC 606-10-50-12
and ASC 606-10-
50-18 for guidance.
Note 8 - Term loan, page F-25
19. Please expand your disclosure to include the interest rate for
borrowings under the term
loan for 2020 along with the effective interest rate. Please also
address this comment for
Note 6 to your interim financial statements.
Note 9 - Common stock warrant liability, page F-26
20. We note that your disclosure that the fair value of the Series W
warrant was determined
by valuation specialists. Please tell us the nature and extent of the
valuation specialists
involvement and whether you believe the valuation expert was acting as
an expert as
Ron Kurtz, M.D.
RxSight, Inc.
June 13, 2021
Page 6
defined under Section 11(a) of the Securities Act of 1933 and Section
436(b) of
Regulation C, such that you must disclose the name of the valuation
expert in the Form S-
1 along with a consent from the valuation expert once the Form S-1 is
publicly filed. If
you conclude the valuation expert is not considered an expert under the
Securities Act,
please revise your filing to clarify. Please also address this comment
for Note 5 to your
interim financial statements for the fair value of the Series W warrant
and also the
estimated fair value of the preferred stock warrants.
Note 2 - Summary of accounting policies
Recent accounting pronouncements, page F-54
21. Please expand your disclosure to include ASU No. 2020-06. Refer to your
disclosure on
page F-22 in Note 2.
General
22. 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 Tracey Houser at (202) 551-3736 or Daniel Gordon at
(202) 551-3486
if you have questions regarding comments on the financial statements and
related
matters. Please contact Jason Drory at (202) 551-8342 or Tim Buchmiller at
(202) 551-3635
with any other questions.
Sincerely,
FirstName LastNameRon Kurtz, M.D.
Division of
Corporation Finance
Comapany NameRxSight, Inc.
Office of Life
Sciences
June 13, 2021 Page 6
cc: Martin J. Waters, Esq.
FirstName LastName