SEC Company Response from MINRAD INTERNATIONAL, INC. (CIK 0001121225) — Sep 7, 2005
MINRAD INTERNATIONAL, INC. (CIK 0001121225)
Date: Sept. 7, 2005 · CIK: 0001121225 · Accession: 0000899797-05-000305
AI Filing Summary & Sentiment
File numbers found in text: 333-126359
Referenced dates: July 28, 2005
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CORRESP
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Correspondence
Ward B. Hinkle
Partner
Direct Dial: 716.848.1281
Direct Facsimile: 716.849.0349
whinkle@hodgsonruss.com
September 7, 2005
Securities and Exchange Commission
100F Street, N.E.
Mailstop 6010
Washington, D.C. 20549
Attention: Song P. Brandon
John Krug
Jeffrey Riedler
Ladies/Gentlemen:
Re:
Minrad International, Inc.
Registration Statement on Form SB-2
File No. 333-126359
This letter responds to your letter dated July 28, 2005 to Minrad
International, Inc. ("Minrad") regarding the above registration. The following
numbered comments respond to your comments with the same numbers contained in
your letter. The changes discussed below are reflected in Amendment No. 1 to the
Registration Statement, which is being filed today.
General
1. SEC Comment: In your response letter, please state our
comment and then explain each change that has been made in response to a
comment. In addition, you should also reference each page number in
which disclosure has been revised in response to a comment so that we
can easily place your revised disclosure in its proper context.
Response: The requested procedure has been followed.
2. SEC Comment: Please note that where we provide examples to
illustrate what we mean by our comments, they are examples and not
complete lists. If our comments are applicable to portions of the filing
that we have not cited as examples, please make the appropriate changes
in accordance with our comments.
Response: The requested procedure has been followed.
3. SEC Comment: We note that you have filed a confidential
treatment request for certain of your exhibits. In that regard, please
be advised that comments related to your requests for confidential
treatment will be delivered under separate cover. We will not be in a
position to consider a request for acceleration of effectiveness of this
registration statement until we resolve all issues concerning the
confidential treatment request.
Response: The confidential treatment requests referred to
relate to (1) a confidentiality request dated 2/24/05 filed with the SEC
on 2/25/05 in connection with Exhibit 10.1 to Form 8-K dated February
17, 2005, which was incorporated by reference as Exhibit 10.5 to the
Form SB-2; and (2) a confidentiality request dated 5/13/05 filed with
the SEC on 5/16/05 in connection with Exhibit 10.8 to the Form 10-QSB
for the quarter ended 3/31/05, which was incorporated by reference as
Exhibit 10.8 to the Registration Statement on Form SB-2. The requested
confidential treatment related solely to item pricing under distribution
agreements and did not appear to raise any significant legal issues. To
date, we have not received any response from the SEC with respect to the
requested confidential treatment. If acceleration of the registration
statement is contingent upon resolution of issues related to the
confidentiality requests filed in February and May, we respectfully
request that you provide us with any comments on those requests
immediately so that we may respond to them.
4. SEC Comment: In your next amendment, please update the
disclosure, including updated financial information, and in your risk
factors section, as of a recent date practicable.
Response: Updated financial information has been provided,
including updated financial information contained in the Risk Factors
section.
5. SEC Comment: Provide interim financial information in
accordance with Item 310(g) of Regulation S-B.
Response: Updated interim financial information in accordance
with Item 310(g) of Regulation S-B has been provided in the financial
statements beginning at page F-1.
6. SEC Comment: Where applicable, please amend your transition
report on Form 10-KSB for the three-months ended December 31, 2004 and
your Form 10-QSB for the quarter ended March 31, 2005 to comply with our
comments on your Form SB-2.
Response: When you have indicated that the changes to the
Registration Statement that we have proposed in response to your
requests are acceptable to you, Minrad will make conforming changes to
its Form 10-KSB for the three-months ended December 31, 2004 and its
Form 10-QSB for the quarter ended March 31, 2005. Please confirm that
you are only requesting conforming changes relating to disclosures about
historical events that occurred during the periods covered by those
reports and not changes relating to disclosures about events that
occurred subsequent to the periods covered by those reports or changes
to forward looking statements made in those reports relating to periods
subsequent to the periods covered by those reports.
Registration Statement Cover Page
7. SEC Comment: Although Form SB-2 does not contain a space to
indicate that the securities are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act, please
revise to include this disclosure.
Response: The language and check-box disclosure for a delayed
or continuous offering pursuant to Rule 415 has been added to the cover
page of Amendment No. 1 to the registration statement.
Prospectus Cover Page
8. SEC Comment: Please revise the third line where you
disclose the number of shares of common stock to say "up to 25,120,561
shares of common stock."
Response: The reference to "up to 25,120,561 shares" has been
added in the third line of the cover page of the prospectus.
Risk Factors, page 4
9. SEC Comment: We note your statement that, "The risks and
uncertainties described below are not the only ones facing our company.
Additional risks and uncertainties may also adversely impair our
business operations." Please eliminate or revise these sentences as they
imply that there are other risks that the investors should consider
before investing in your company when the risk factors section should
list all of the risks key to an investment decision.
Response: The two sentences in the first paragraph on page 4
of the prospectus have been deleted as requested.
"We are currently in a growth stage and may experience setbacks in both
business ....," page 4
10. SEC Comment: Please clarify how long you have been
manufacturing and marketing inhalation anesthetics.
Response: Statement concerning the date on which the Company
commenced manufacturing and marketing inhalation anesthetics and the
status of production and marketing of the SabreSourceTM
system have been inserted in the subject risk factor.
11. SEC Comment: Please also clarify when you launched the
SabreSource system, and explain how your operations in producing this
system have been limited. Please provide examples to illustrate your
point.
Response: The disclosure in the subject risk factor has been
modified to clarify that Minrad has just began production of SabreSource
for testing purposes in August of 2005 and that Minrad expects to begin
marketing SabreSource in September of 2005.
"We have historically experienced operating losses and expect to
continue to ....," page 5
12. SEC Comment: To the extent possible, please quantify the
significant up-front expenditures you have incurred in the production
and marketing activities of your inhalation anesthetics and image
guidance system products as well as the amount of revenue you have
derived from the sale of these products to date.
Response: Additional disclosure concerning accumulated
aggregate deficits and revenues has been inserted in the risk factor.
Please note that the reference to "up-front expenditures" is intended to
refer to all expenditures that may be incurred in the future before
significant revenues are realized. Your question, for disclosure of all
"significant" up-front expenditures that have already been experienced
in the production and marketing of inhalation anesthetics and image
guidance system products would require a recapitulation of the
expenditures incurred by Minrad since its inception in 1994. With regard
to image guidance, most of Minrad's revenues were generated during the
period that it actively marketed its first generation DRTS® system from
1999 to 2002, a period for which Minrad does not have discrete, separate
financial information between the lines of business.
Moreover, although Minrad's up-front expenditures have been large
(as reflected by its cumulative deficit), their size has resulted more
from their cumulating over many years than from the magnitude of
individual expenditures. The acquisition of the Bethlehem, PA plant for
$1.36 million in December of 2000 was the largest single expenditure.
Because of the extended time period and the lack of large, individual
expenditures, we believe that quantification of individual up-front
expenditures would not appear to be meaningful or helpful to investors.
Minrad has provided revenue information for the period from October
1, 2002 through June 30, 2005 in the risk factor.
"We will need to raise additional capital to fulfill our business
strategies. We may ....," page 5
13. SEC Comment: We note your disclosure relating to the need
to raise additional capital. To the extent possible, please quantify how
much capital you intend to need or raise in the next 12 to 18 months.
Please also provide similar disclosure in your Liquidity and Capital
Resources section.
Response: The disclosure under this risk factor has been
revised to indicate the uncertainties concerning the amount of
additional funding that may be required in the short to term and to
indicate the prospective amounts and sources that Minrad has currently
planned to raise. Similar disclosure has been provided in the "Liquidity
and Capital" section on page [__].
14. SEC Comment: Please disclose how long you will be able to
maintain your operations without obtaining additional funds. To the
extent possible, please put your cash needs in a context by stating the
amount of cash you currently have available to you and the average
amount of cash you are using on a monthly basis. Please also provide
similar disclosure in your Liquidity and Capital Resources section.
Response: As indicated in the revised risk factor, Minrad is
unable to estimate its expenses and revenues with sufficient accuracy to
reasonably predict how long it could maintain its operations without
obtaining additional funds. Information concerning cash available and
average monthly cash usage has been provided in the risk factor.
15. SEC Comment: In addition, please note that each risk
factor should discuss one risk. We note that the discussion in the last
three sentences of this risk factor appear to be discussing two separate
risks. More specifically, the separate risk that if you issued
additional capital, the dilution consequences of such an issuance; and
the separate risk of debt financing, which may involve unfavorable
financial terms or significant restrictive covenants. Please revise this
section such that each risk factor is presented separately.
Response: As requested, the last three sentences of the risk
factor have been revised into two new risk factors that follow
immediately after the subject risk factor.
"The loss of the services of key personnel would adversely affect our
business....," page 6
16. SEC Comment: Please identify the positions that each of
William Burns and John McNeirney have with your company in this risk
factor.
Response: The positions of Mr. Burns and Mr. McNeirney have
been indicated in the risk factor.
17. SEC Comment: Please also briefly indicate the status of
your conscious sedation program, including when you expect to complete
the program.
Response: Disclosure that of the expected completion date for
the conscious sedation program has been added to the risk factor.
18. SEC Comment: In addition, please indicate if you maintain
any key life insurance policies or employment agreements with these
individuals.
Response: Disclosure concerning key-man life insurance
policies and employment agreements for Messrs. Burns and McNeirney has
been added to the risk factor.
"We must hire and retain skilled technical and managerial personnel,"
page 6
19. SEC Comment: To the extent that you have experienced
problems hiring or retaining employees, please revise to disclose the
problems and resulting consequences.
Response: The risk factor has been revised to emphasize the
fact that this is a prospective risk. Minrad has not experienced
significant problems hiring or retaining employees to date, but with the
anticipated growth of the company and the concomitant need to
substantially increase its technical and marketing staff, acquisition
and retention of these kinds of employees is a foreseeable problem.
"We depend on strategic partnerships and relationships," page 7
20. SEC Comment: To the extent you have established any
alliances with strategic partnerships and relationships that you believe
are material to your business, please identify those partnerships and
relationships in the Business section of your prospectus, please provide
the material terms of any agreements you have with such partners. Please
also file the agreements as exhibits to your registration statement. In
the alternative, please provide an analysis as to why such agreements
are not material to you.
Response: Minrad has material distributorship agreements with
RxElite Corporation and with Merck Génériques. (Please note that
references to "E. Merck" have been replaced with references to "Merck
Génériques," the company's formal name). Additional description of the
RxElite Agreement has been added to its description under BUSINESS --
Anesthesia and Analgesia Competitive Strategy on page [43] and a new
paragraph concerning the Merck Génériques agreement has been added
immediately thereafter. The agreements were previously filed as exhibits
10.5 and 10.8 to the registration statement. Minrad has numerous other
distributorship arrangements (none of which are currently material to
its revenues) for inhalation anesthesia products, which are