SEC Company Response from LANGER INC (CIK 0000725460) — Jan 28, 2005
LANGER INC (CIK 0000725460)
Date: Jan. 28, 2005 · CIK: 0000725460 · Accession: 0001047469-05-001852
AI Filing Summary & Sentiment
File numbers found in text: 333-120718
Referenced dates: December 23, 2004
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KANE KESSLER, P.C.
1350 AVENUE OF THE AMERICAS
NEW YORK, NEW YORK 10019
(212) 541-6222
January 28, 2005
VIA
EDGAR
Securities
and Exchange Commission
450 Fifth Street, NW
Washington, D.C. 20549
Attention:
Peggy A. Fisher
Assistant Director
Re:Langer, Inc.
Form S-1 filed November 23, 2004
File No. 333-120718
Dear
Ms. Fisher:
We
hereby submit in electronic format with the Securities and Exchange Commission (the "Commission"), pursuant to the Securities Exchange Act of 1934, as amended (the "Act"), and
Regulation S-T, Amendment No. 1 to the Registration Statement on Form S-1 of Langer, Inc. ("Langer" or the "Company").
The
Form S-1 has been revised in response to the Staff's comments contained in the Commission's letter of comment (the "Staff Letter") dated December 23, 2004.
In connection therewith, set forth on Schedule A hereto are the Company's responses to the Staff Letter, which have been listed in the order of the comments from the Staff Letter.
Please
feel free to contact me at (212) 519-5115, with any questions regarding the foregoing.
Very truly yours,
Steven E. Cohen
Enclosure
cc:Adelaja
Heyliger (with courtesy copy via Federal Express)
Schedule A—Responses of Langer, Inc. to the
Commission Staff Comment Letter dated December 23, 2004
Prospectus Summary—Pages 1 to 4
1.The disclosure in the Summary should be a balanced presentation of your business. Please balance the disclosure of your strengths with a brief discussion of the
principal challenges or risks associated with your company, many of which are identified in your Risk Factors section.
The
Company has revised the S-1 in response to the Staff's comment. Please see the marked changes on page 4.
2.Please provide copies of the industry reports cited throughout the registration statement, clearly marking the relevant sections. For example, you cite unnamed
"independent research" projections on pages 2 and 47.
Our
market estimates are based in part upon the following reports, copies of which are being sent under separate cover:
(a) "Orthopedic
Orthotics" and "Orthopedic Prosthetics" (included), furnished to the Company by: Global Industry Analysts, Inc., 5645 Silver Creek Valley Road, Suite 200 San
Jose, California 95138, Phone: (408) 528-9966, www.globind.com; and
(b) "Cosmeceuticals:
Global Markets & Breakthrough Therapies" (included) furnished to the Company by: PJB Medical Publications Inc., 1775 Broadway, Suite 511,
New York, NY 10019, Phone: (212) 262-8230, www.thetareports.com.
Below
please find our analysis with respect to each of the following statements:
•page 2,
paragraph 3 and page 57, paragraph 3:
"Based
on third-party research, we believe that the global orthopedic markets that we target represented approximately $2.4 billion in sales in 2003, with the United States accounting for
approximately half of this amount, and are expected to grow to approximately $3.4 billion by the end of 2008."
2003 market estimate:
US$ millions
Source
Global Rehabilitative Orthotics Market
627.9
"Orthopedic Orthotics" page II-20, Table 6
Global Orthopedic Bracings Market
705.4
"Orthopedic Orthotics" page II-21, Table 8
Prosthetic Componentry1
1,077.1
"Orthopedic Prosthetics" page II-41, Table 11
Total
2,410.4
A-1
1Estimate of 25% of U.S. and European Orthopedic Prosthetics Market, see below:
US$ millions
Source
U.S. Orthopedic Prosthetics Market
2,862.9
"Orthopedic Prosthetics" page II-41, Table 11
European Orthopedic Prosthetics Market
1,445.7
"Orthopedic Prosthetics" page II-41, Table 11
Total
4,308.5
25% of Total
1,077.1
2008 market estimate:
US$ millions
Source
Global Rehabilitative Orthotics Market
876.7
"Orthopedic Orthotics" page II-20, Table 6
Global Orthopedic Bracings Market
939.7
"Orthopedic Orthotics" page II-21, Table 8
Prosthetic Componentry1
1,560.4
"Orthopedic Prosthetics" page II-41, Table 11
Total
3,376.7
1Estimate of 25% of U.S. and Canadian Orthopedic Prosthetics Market, see below:
US$ millions
Source
U.S. Orthopedic Prosthetics Market
4,157.6
"Orthopedic Prosthetics" page II-41, Table 11
European Orthopedic Prosthetics Market
2,083.8
"Orthopedic Prosthetics" page II-41, Table 11
Total
6,241.4
25% of Total
1,560.4
•page 3,
paragraph 2 and page 58, paragraph 2:
"Based
on third party research we believe that the U.S. skincare moisturizer market, which is the market we target, represented approximately $2.0 billion in sales in 2003 and is expected to
grow to approximately $2.5 billion by the end of 2008."
A-2
Calculations
2003 market estimate:
US$ millions
Source
2003 Skincare Market
2,753.5
"Cosmeceuticals" page 56, Table 4-7
2003 Scar Management Skincare
44.7
"Cosmeceuticals" page 187, Table 11-5
Total
2,798.2
Total @ 70% (moisturizer)
1,958.7
"Cosmeceuticals" page 52, Paragraph 3
2008 market estimate:
US$ millions
Source
2008 Skincare Market
3,582.5
"Cosmeceuticals" page 56, Table 4-7
2008 Scar Management Skincare
55.5
"Cosmeceuticals" page 187, Table 11-5
Total
3,368.0
Total @ 70% (moisturizer)
2,546.6
"Cosmeceuticals" page 52, Paragraph 3
A-3
3.Please provide supplemental support for your stated belief that your brand names "represent a high level of quality in the markets in which
[you] sell."
The
Company believes its products represent a high level of quality based on third-party studies commissioned by the Company. Nevertheless, the Company has revised the S-1 to remove the
previous references to high quality.
Please
see the marked changes on pages 1 and 56.
4.Please disclose, or estimate if not currently known, the transaction costs associated with the Silipos acquisition. Additionally, please describe and quantify
the working capital adjustments to the Silipos acquisition price.
The
Company has revised the S-1 in response to the Staff's comment regarding disclosure of transaction costs. Please see the marked changes on pages 1 and 56.
The
Company has also revised its description of the working capital adjustment to the Silipos acquisition price. Please see the marked changes on pages 1 and 56. The Company believes that,
based on its current calculations, this working capital
adjustment may result in a decrease to the purchase price paid by the Company by as much as $800,000. The Seller is disputing the Company's position pursuant to the purchase agreement and,
accordingly, the Company believes it would be inappropriate to publicly disclose this estimate at the present time.
Risk Factors—Pages 8 to 18
There are significant risks associated with our strategy....—Page 9
5.Please expand your disclosure to address the risk of dilution to a new investors associated with your use of stock to finance future
acquisitions.
The
Company has revised the S-1 in response to the Staff's comment by adding a new Risk Factor under the heading "We may issue a substantial amount of our common stock in the future which
could cause dilution to new investors and otherwise adversely affect our stock price" on page 20.
We may face difficulties integrating the operations of Silipos—Page 10
6.Please describe the "various risks" specifically associated with your integration of Silipos' operations. Additionally, please tell us whether you have
experienced any such material integration delays or unexpected costs that have resulted in or are expected to result in a materially adverse impact to your business and
operations.
The
Company has revised the S-1 in response to the Staff's comment. Please see the marked changes on page 9.
A-4
The
Company has not experienced any material integration delays or unexpected costs with respect to Silipos to date that have resulted in or are expected to result in a materially adverse impact to
our business and operations.
We may be adversely affected by legal actions or proceedings commenced against us—Page 10
7.Please tell us the basis for your belief that Poly-Gel may raise such claims or bring legal action against you. If you are currently aware of
Poly-Gel's intention to pursue such claims against you, please disclose this fact. This risk factor's heading, and disclosure on page 40, suggest that Poly-Gel has
already commenced an action or proceeding. If this is in fact the case, please revise and add appropriate disclosure here and in the Legal Proceeding section of the prospectus.
The
basis of the Company's belief that Poly-Gel may raise such claims or bring legal action against it is the Company's knowledge of discussions that occurred between Poly-Gel
and SSL International, plc, the party from whom the Company acquired Silipos, in mid-2003 in which Poly-Gel intimated it might bring action against Silipos for the types of
claims described in the Risk Factor if Silipos began manufacturing its own oil-based gels. Because of this, the Silipos acquisition agreement contained provisions specifically intended to
address possible claims by Poly-Gel. The Company has no knowledge that Poly-Gel has any current intention to bring the actions described in the Risk Factors against the
Company. Moreover, since no action or proceeding has been commenced, the Company has revised the heading for this Risk Factor in order to clarify that fact. Please see the marked changes on
pages 10 and 11.
Our existing purchase arrangements may be adversely affected...- Page 10
8.Please describe this risk in more concrete terms by disclosing the circumstances under which third-party manufacturers can alter the terms of or be released
from your supply agreements. Additionally, please tell us whether any of these agreements, alone or in the aggregate, are material and file all material supply agreements as exhibits. Also, with a
view towards disclosure, please tell us the time you would need to replace any key supplier.
Although
there are suppliers that supply products or materials that are material to the Company's business, none of them supply the Company with products or materials that the Company believes could
not otherwise be readily purchased or substituted for from other sources without significant delay or significant additional expense to the Company. The Company has not disclosed this in the Risk
Factor as it may tend to mitigate the actual risk being disclosed to investors.
The
Company has revised the S-1 in response to the Staff's comment. Please see the marked changes on page 61.
9.For the two most recently completed fiscal years, and in the nine months ended September 30, 2004, disclose whether you experienced any such
interruptions or delays that resulted
A-5
in a materially adverse impact to your business and operations, and if so, how the matter was resolved.
The
Company has not experienced any such interruption or delay for each of the two years ended December 31, 2002 and 2003, and for the nine months ended September 30, 2004. The Company
has not disclosed this in the Risk Factor as it may tend to mitigate the actual risk being disclosed to investors.
We may not be successful in manufacturing the raw material oil based gels.... —Page 11
10.Disclose why you did not renew Silipos' supply agreement with Poly-Gel and opted to begin manufacturing gels on your own.
The
Company has revised the S-1 in response to the Staff's comment. Please see the marked changes on page 11.
The nature of our business could subject us to potential product liability...claims. Page 11.
11.Please tell us how you determined that your current insurance coverage is adequate and reconcile this statement with your disclosure on page 12
that your existing coverage "may be inadequate to protect [you]" from liabilities you may incur.
The
Company believes that its current level of insurance is adequate based on its consultations with its insurance brokers and underwriters. The language in the Risk Factor reflects the
possibility of a large judgment that any manufacturer may face in a product liability claim as well as the vagaries of the insurance coverage market. Nonetheless, the Company has revised this
Risk Factor by deleting the sentence regarding the adequacy of its insurance coverage, thus avoiding any inconsistencies with the risk being disclosed to investors. Please see the marked changes on
page 12.
12.Additionally, please disclose whether, in the two most recently completed fiscal years, and in the nine months ended September 30, 2004, you experienced
any such product liability claims that resulted in a materially adverse impact to your business and operations.
The
Company has not experienced any product liability claims that resulted in a materially adverse impact to it during the two years ended December 31, 2002 and 2003, and the nine months ended
September 30, 2004. The Company has not disclosed this in the Risk Factor as it may tend to mitigate the actual risk being disclosed to investors.
Changes in government and other third-party payor reimbursement levels...—Page 13
13.Please quantify the portion of your historical revenues comprised of Medicare and Medicaid payments.
Since
the Company does not receive any payments directly from Medicare or Medicaid it is unable to quantify the portion of its historical revenues derived indirectly from such payments. However, the
Company is aware that a number of its customers are reimbursed
A-6
by
Medicare and Medicaid. The Risk Factor discloses the Company's exposure to potential decreases in such reimbursements, and the Company feels that this Risk Factor is appropriate disclosure even
though it is unable to quantify the extent to which its sales are dependent upon such reimbursements.
Our products may be subject to product recalls...—Page 14
14.Please describe any past mandatory or voluntary recalls that have had a material adverse effect on your business.
There
have not been any past mandatory or voluntary recalls that have had a material adverse effect on the Company's business.
Our business, operating results and financial condition could be adversely affected if we become involved in litigation regarding our...intellectually property rights—Page 14
15.Please disclose whether you are currently aware of any parties currently intending to pursue such intellectual property claims against
you.
The
Company is not aware of any party currently intending to pursue intellectual property claims against it. The Company has not disclosed this in the Risk Factor as it may tend to mitigate the actual
risk being disclosed to investors. While the Company is not aware of any current intention on the part of Poly-Gel to bring any intellectual property claims against it, as discussed in the
Company's response to Comment No. 7, above, the Company has reason to believe that it could be subject to such claims being brought against it. Accordingly, the Company has disclosed these
potential claims in this Risk Factor as well. Please see marked changes on pages 15 and 16.
A portion of our revenues and expenditures is subject to exchange rate fluctuations that could adversely affect our reported results of operations—Page 16
16.Please demonstrate this risk by quantifying any material reductions in sales and profitability recently experienced due to foreign currency
fluctuations.
The
Company has not recently experienced any material reductions in sales and profitability due to foreign currency fluctuations because the value of the local currencies referenced in the Risk
Factor, and particularly the British pound and Canadian dollar, have increased in value relative to the U.S. dollar. However, the Company faces a risk that its sales would be affected by any increase
in the value of the U.S. dollar compared to these other currencies. The Risk Factor has been revised to reflect this risk. Please see the marked changes on page 17.
Our quarterly results are subject to fluctuations.—Page 16
17.Please briefly explai