SEC Company Response from OccuLogix, Inc. (CIK 0001299139) — Oct 7, 2004
OccuLogix, Inc. (CIK 0001299139)
Date: Oct. 7, 2004 · CIK: 0001299139 · Accession: 0000909567-04-001376
AI Filing Summary & Sentiment
File numbers found in text: 333-118204
Show Raw Text
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
<PAGE>
TORYS LLP
NEW YORK TORONTO Suite 3000
79 Wellington St. W.
Box 270, TD Centre Andrew Beck
Toronto, Ontario Direct Tel. 212.880.6010
M5K 1N2 Canada abeck@torys.com
TEL 416.865.0040
FAX 416.865.7380
www.torys.com
October 7, 2004
Securities and Exchange Commission
450 Fifth Street, NW
Washington, DC 20549
Attention: Ms. Peggy Fisher
RE: OCCULOGIX, INC. REGISTRATION STATEMENT ON FORM S-1
COMMISSION FILE NO. 333-118204 FILED ON AUGUST 13, 2004
On behalf of our client, OccuLogix, Inc. (the "Company"), we
transmit for your review Amendment No. 1 to the Registration Statement on Form
S-1 (the "Amended Form S-1") of the Company, which amends the Registration
Statement on Form S-1 (File No. 333-118204) (the "Form S-1") of the Company
filed on August 13, 2004.
The Amended Form S-1 reflects changes made in response to the
comment letter received from the Staff of the Securities and Exchange Commission
(the "Commission"), dated September 13, 2004 (the "Comment Letter"). The page
numbers referenced in the responses included in this letter refer to the
enclosed marked EDGAR submission of the Amended Form S-1. This letter provides
responses and supplemental information in response to the comments of the Staff
and is keyed to the headings and comment numbers contained in the Comment
Letter.
GENERAL
1. PLEASE CONFIRM THAT ANY PRELIMINARY PROSPECTUS YOU CIRCULATE WILL
INCLUDE ALL NON-RULE 430A INFORMATION. THIS INCLUDES THE PRICE RANGE
AND RELATED INFORMATION BASED ON A BONA FIDE ESTIMATE OF THE PUBLIC
OFFERING WITHIN THAT RANGE. ALSO NOTE THAT WE MAY HAVE ADDITIONAL
COMMENTS AFTER YOU INCLUDE THIS INFORMATION.
The Company confirms that any preliminary prospectus that is
circulated to potential purchasers will include all non-Rule 430A
information. The Company notes the Staff's comment that it may have
additional comments after it has included this information.
<PAGE>
- 2 -
2. PLEASE FILL IN THE BLANKS IN YOUR DOCUMENTS SO THAT WE MAY CONTINUE
OUR REVIEW.
In response to the Staff's comment, the Company has completed as many
blanks in the Amended Form S-1 as is possible at this time. As
indicated in the response to the Staff's comment number 1, the Company
will complete all non-Rule 430A information in the version of the
preliminary prospectus that will be circulated to potential
purchasers.
3. IF YOU INTEND TO INCLUDE ANY GRAPHICS IN THE PROSPECTUS, PLEASE SUBMIT
THEM FOR OUR REVIEW.
The Company notes the Staff's comment and will be submitting the
graphics it proposes to include in the prospectus shortly for the
Staff's review, and in any event prior to the insertion of the
graphics in the preliminary prospectus that will be circulated to
potential purchasers.
4. PLEASE MINIMIZE THE USE OF TECHNICAL MEDICAL TERMINOLOGY OR OTHER
WORDS OR PHRASES THAT MAY BE UNFAMILIAR TO THE AVERAGE INVESTOR IN THE
SUMMARY AND RISK FACTORS SECTION. SEE UPDATED STAFF LEGAL BULLETIN NO.
7 (CF). IN ADDITION, IF YOU INCLUDE TECHNICAL TERMS IN THE BODY OF
YOUR PROSPECTUS, PLEASE
<PAGE>
- 3 -
CONCISELY EXPLAIN THESE TERMS WHERE YOU FIRST USE THEM IN DISCUSSION.
FOR EXAMPLE, WE NOTE TERMS SUCH AS RHEOPHERESIS, APHERESIS, BCVA,
FRCSC, MORPHOMETRY, AND ELECTROPHYSIOLOGICAL FUNCTION.
In response to the Staff's comment, the Company has revised the
disclosure throughout the Amended Form S-1.
5. PLEASE PROVIDE AN OBJECTIVE SUPPORT FOR THE FOLLOWING STATEMENTS:
o OUR RHEO SYSTEM IS THE ONLY DRY AMD TREATMENT TO TARGET WHAT WE
BELIEVE TO BE THE UNDERLYING CAUSE OF AMD RATHER THAN ITS
SYMPTOMS (PAGES 1 AND 38); AND
o RHEO THERAPY IS CURRENTLY THE ONLY DRY AMD THERAPY THAT...
APPEARS TO IMPROVE VISION IN SOME PATIENTS (PAGE 2).
In response the Staff's comment, the Company has supplementally
provided copies of the articles, Influence of Membrane Differential
Filtration of the Natural Course of Age-Related Macular Degeneration
and the Annual Meeting of the German Society for Clinical
Microcirculation and Hemorheology (attached as
<PAGE>
- 4 -
Appendix A) written by Dr. Richard Brunner and published in
peer-reviewed scientific journals, which objectively support the
statements noted above.
6. WE NOTE THE STATISTICS YOU ATTRIBUTE TO VARIOUS THIRD PARTIES
THROUGHOUT THE PROSPECTUS INCLUDING, AMONG OTHERS, THE FOLLOWING:
o DRY AMD AFFLICTS APPROXIMATELY 13.0 TO 13.5 MILLION PEOPLE IN THE
UNITED STATES, REPRESENTING APPROXIMATELY 85% TO 90% OF ALL AMD
CASES (PAGES 1, 38, AND 40);
o APPROXIMATELY 15 MILLION PEOPLE IN THE UNITED STATES SUFFER FROM
AMD (PAGES 2 AND 39);
o THE CATEGORY 3 AND THE CATEGORY 4 DRY AMD POPULATION...
REPRESENTS APPROXIMATELY 54% OF THE TOTAL U.S. DRY AMD PATIENTS,
OR CURRENTLY 8 MILLION PEOPLE (PAGE 2);
o THE PREVALENCE OF AMD INCREASES SHARPLY WITH AGE, FROM 18% AMONG
PEOPLE 65 TO 74 YEARS OF AGE TO 47% AMONG PEOPLE 85 YEARS AND
OLDER (PAGE 39); AND
<PAGE>
- 5 -
o THE PREVALENCE OF AMD AMONG A SELECTED SAMPLE OF U.S. RESIDENTS
AGED 65 AND OLDER WAS 27% IN 1999 (PAGE 39).
PLEASE SUPPLEMENTALLY PROVIDE US WITH COPIES OF THE MATERIALS THAT
SUPPORT THE STATISTICS CITED, CLEARLY MARKING THE RELEVANT SECTIONS.
IN ADDITION, PLEASE TELL US WHETHER THOSE THIRD PARTIES HAVE CONSENTED
TO YOUR USE OF THEIR DATA AND WHETHER ANY OF THE REPORTS WERE PREPARED
SPECIFICALLY FOR YOUR USE.
In response to the Staff's comment, the Company has supplementally
provided copies of the materials (attached as Appendix B) to support
the statistics cited in the Amended Form S-1.
In addition, the Company advises the Staff that the reports cited are
public and therefore the Company believes that no third party consents
are required. Furthermore, the Company confirms that no reports were
prepared specifically for their use.
<PAGE>
- 6 -
7. NEWS ARTICLES REPORT THAT YOUR TREATMENT COULD BE LAUNCHED IN THE
SECOND HALF OF 2005. SEE E.G. TLC SUBSIDIARY FILES FOR IPO IN CANADA,
THE GLOBE AND MAIL, SEP. 1, 2004, AT B11; TLC SPINOFF FILES FOR SHARE
OFFERING, THE GLOBE AND MAIL, AUG. 14, 2004, AT B2. THIS APPEARS TO BE
INCONSISTENT WITH THE DISCLOSURE IN THE PROSPECTUS THAT YOU WOULD NOT
GENERATE SIGNIFICANT REVENUES UNTIL LATE 2006. PLEASE SUPPLEMENTALLY
ADVISE IF YOU OR YOUR AFFILIATES PROVIDED SUCH INFORMATION TO THE
MARKET OR MEDIA.
Neither the Company nor its affiliates provided such information to
the market or media. The Company believes that the writers of the
articles obtained the information contained in the articles by
reviewing previously published research reports on the Company's
affiliate, TLC Vision Corporation.
PROSPECTUS COVER PAGE
8. DISCLOSE THAT YOUR MAJOR SHAREHOLDER, TLC VISION CORPORATION,
CURRENTLY HOLDS 65.8% OF YOUR OUTSTANDING SHARES AND PLANS TO SELL
_______ SHARES IN THIS OFFERING.
In response to the Staff's comment, the Company has revised the
disclosure on the Prospectus cover page.
<PAGE>
- 7 -
9. THE UNDERWRITER SHOULD BE AWARE OF THE STAFF'S LONG-STANDING AND
UNCHANGED POSITION THAT THE TERM "SOLE BOOK-RUNNER" SHOULD BE REMOVED
FROM THE COVER PAGE. PLEASE COMPLY. YOU MAY, HOWEVER, INCLUDE THIS
LANGUAGE ON THE BACK COVER PAGE.
In response to the Staff's comment, the Company has removed the term
"Sole Book-Runner" from the Prospectus cover page.
<PAGE>
- 8 -
PROSPECTUS SUMMARY - PAGE 1
10. PLEASE PROVIDE INDEPENDENT SUPPORT FOR YOUR BELIEF THAT POOR
MICROCIRCULATION AND THE GRADUAL BUILD-UP OF CELLULAR WASTE MATERIAL
CONTRIBUTE TO THE DEVELOPMENT OF DRY AMD AND FOR THE EFFICACY OF YOUR
PROCESS.
In response to the Staff's comment, the Company has supplementally
provided a copy of the interim analysis of the MIRA-1 study (attached
as Appendix C), which independently supports the efficacy of
Rheophoresis and the Company's belief that poor microcirculation and
the gradual build-up of cellular waste material contribute to the
development of Dry AMD.
11. CLARIFY THAT TO DATE YOU HAVE RECEIVED RESULTS FOR 36 PATIENTS IN THE
MIRA-1 CLINICAL TRIAL, ONE THIRD OF WHICH ARE IN THE PLACEBO GROUP.
In response to the Staff's comment, the Company has revised the
disclosure on page 1.
<PAGE>
- 9 -
12. QUANTIFY WHAT YOU MEAN BY "WORSE THAN LEGAL DRIVING VISION" AND THE
DEGREE TO WHICH VISION IMPROVED IN 58% OF THE PATIENTS. DISCUSS THE
EXTENT TO WHICH YOU HAVE ESTABLISHED WHETHER IMPROVEMENTS ARE LONG
TERM, AS WELL AS SHORT TERM.
In response to the Staff's comment, the Company has revised the
disclosure on page 1.
13. BRIEFLY DESCRIBE THE EXTENT OF THE AFFILIATION OF THE REGISTRANT WITH
TLC VISION CORPORATION.
In response to the Staff's comment, the Company has revised the
disclosure on page 1.
14. IN THE FOREPART, PLEASE BRIEFLY DESCRIBE THE STATUS OF YOUR PRODUCTS'
REGULATORY APPROVAL, AND STATE THAT YOU DO NOT EXPECT TO GENERATE
REVENUES IN THE UNITED STATES OR MATERIALLY INCREASE SALES IN CANADA
UNTIL LATE 2006, AT THE EARLIEST.
In response to the Staff's comment, the Company has revised the
disclosure on pages 1, 2 and 29 to include a description of the status
of their products'
<PAGE>
- 10 -
regulatory approval and the statement that they do not expect to
generate revenues in the United States. The Company advises the Staff
that they have not, however, included a statement disclosing that they
do not expect to increase sales in Canada until late 2006 at the
earliest because they have approval to sell their products in Canada
and they expect an increase in sales to occur in the near future. The
Company has, in fact, signed an agreement with Rheotherapeutics to
purchase approximately 8,000 treatment sets with the option to
purchase 2,000 additional treatment sets by 2005 as well as an
estimated 20 OctoNova pumps. The Company has revised the disclosure on
pages 2 and 40 to disclose this purchase.
15. EXPAND THE SECOND PARAGRAPH ON PAGE 2 TO CLARIFY THE EXTENT TO WHICH
THERAPIES FOR WET AMD HAVE RECEIVED FDA APPROVAL.
In response to the Staff's comment, the Company has revised the
disclosure on page 2.
16. WE NOTE THE ADVANTAGES OF YOUR RHEO SYSTEM DESCRIBED IN "OUR SOLUTION"
SUBSECTION. IN ORDER TO PROVIDE A MORE BALANCED DISCLOSURE, PLEASE
IDENTIFY THE DISADVANTAGES OF YOUR SYSTEMS INCLUDING THE POSSIBLE SIDE
EFFECTS AND BRIEFLY DISCUSS THE SIGNIFICANT RISKS RELATED TO THE
INVESTMENT IN YOUR COMPANY.
<PAGE>
- 11 -
In response to the Staff's comment, the Company has revised the
disclosure on page 3.
<PAGE>
- 12 -
17. YOU INDICATE THAT YOU ARE "CURRENTLY" IDENTIFYING MULTI-FACILITY
HEALTH CARE SERVICE PROVIDERS AND ALSO SEEKING TO ESTABLISH MEDICARE
REIMBURSEMENT FOR RHEO THERAPY. IN AN APPROPRIATE SECTION, PLEASE
DESCRIBE THE STATUS OF ANY CONTACT OR NEGOTIATION. CONSIDERING THE
FACT THAT YOU DO NOT HAVE FDA APPROVAL TO COMMERCIALIZE THE PRODUCT
AND THAT SALES IN THE US WILL NOT BEGIN UNTIL LATE 2006, PLEASE
DESCRIBE HOW MUCH YOU ARE FOCUSING ON SUCH MARKETING ACTIVITIES.
Prior to obtaining FDA approval, the Company is not permitted to
market RHEO Therapy to potential patients or service providers. Thus,
until FDA approval has been received, as is currently stated in the
Form S-1, the Company's marketing activities have been limited to
identifying who they will chose to market to upon obtaining FDA
approval. In response to the Staff's comments, the Company has revised
its disclosure concerning Medicare reimbursement on pages 4 and 46.
18. YOU STATE THAT MIRA-1 FOLLOWS TEN YEARS OF SUCCESSFUL CLINICAL TRIALS
AND STUDIES ON RHEOPHERESIS CONDUCTED OUTSIDE UNITED STATES. PLEASE
CLARIFY IF YOUR RHEO SYSTEM HAS BEEN PUT IN CLINICAL TRIAL FOR TEN
YEARS OUTSIDE THE UNITED STATES. DISCLOSE IF YOUR SYSTEM HAS BEEN
APPROVED IN FOREIGN COUNTRIES FOR COMMERCIAL USE.
<PAGE>
- 13 -
In response to the Staff's comment, the Company has revised the
disclosure on pages 1, 2, 40 and 41.
19. ON PAGE 3, YOU STATE THAT AMA IN JANUARY 2003 ESTABLISHED AN INSURANCE
BILLING CODE THAT ACCURATELY CHARACTERIZES THE RHEO THERAPY PROCEDURE
AND THAT MEDICARE CURRENTLY COVERS AND PAYS FOR OTHER FDA-LICENSED
SERVICES BILLED WITH THIS CODE ONLY WHEN PERFORMED IN A HOSPITAL
OUTPATIENT SETTING. PLEASE CLARIFY WHAT PROCEDURES THE NEW INSURANCE
BILLING CODE COVERS, AND DISCLOSE IF THERE IS A THERAPY SIMILAR TO
RHEO THAT IS CURRENTLY PERFORMED TO OUTPATIENTS. ALSO, SINCE YOU ARE
YEARS AWAY FROM FDA APPROVAL, DELETE MULTIPLE DISCUSSIONS ON MEDICAL
REIMBURSEMENT. WE NOTE THE BOTTOM OF PAGE 1.
In response to the Staff's comments, the Company has revised its
disclosure concerning Medicare reimbursement on pages 4 and 46. The
Company supplementally advises that it deleted references in the
"Summary - Our Company" and the "Business - Overview" sections.
20. UNDER THE CAPTION "OUR SOLUTION," BRIEFLY DESCRIBE THE PROCESS YOU USE
TO FILTER THE BLOOD. ALSO DISCLOSE WHAT CONSTITUTES "AN INITIAL COURSE
OF RHEO THERAPY."
<PAGE>
- 14 -
In response to the Staff's comment, the Company has revised the
disclosure on pages 2 and 3.
21. IN AN APPROPRIATE SECTION, PLEASE DESCRIBE YOUR BUSINESS IN CANADA.
DESCRIBE THE STATUS OF REGULATORY APPROVAL BY THE CANADIAN GOVERNMENT,
AND DISCLOSE WHETHER THE PRODUCT AND SERVICES ARE COMMERCIALLY
PROVIDED TO AMD PATIENTS.
In response to the