December 22, 2004
Andrew Makrides
President, Chief Executive Officer
Bovie Medical Corporation
734 Walt Whitman Road
Melville, New York 11747
Re: Bovie Medical Corporation
Registration Statement on Form S-3 filed November 23, 2004
Registration No. 333-120741
Dear Mr. Makrides:
We have reviewed your filing and have the following
comments.
Where indicated, we think you should revise your document in
response
to these comments. If you disagree, we will consider your
explanation as to why our comment is inapplicable or a revision is
unnecessary. Please be as detailed as necessary in your
explanation.
In some of our comments, we may ask you to provide us with
supplemental information so we may better understand your
disclosure.
After reviewing this information, we may or may not raise
additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call us at the telephone numbers
listed
at the end of this letter.
Registration Statement on Form S-3
General
1. We note that the certifications filed as Exhibits 31.1 and 31.2
to
your Form 10-KSB and Forms 10-QSB that have been incorporated into
your registration statement were not in the proper form. The
required certifications must be in the exact form prescribed and
the
wording of the required certifications may not be changed in any
respect. For example, we note that paragraph 4 of Exhibits 31.1
does
not follow the form prescribed by Item 601(b)(31) of Regulation S-
B.
Accordingly, please file an amendment to each of your latest Form
10-
KSB and subsequent Forms 10-QSB that includes the entire report
together with the certifications of each of your CEO and CFO in
the
form currently set forth in Item 601(b)(31) of Regulation S-B.
2. Consideration should be given to the updating requirements of
Item
310(g) of Regulation S-B.
3. A currently dated consent of the independent auditors should be
included in the amendment that will be declared effective. In
addition, the date of the audit report of March 25, 2003
referenced
in the consent does not agree with the date of the report included
in
the 10-KSB of March 30, 2004. Please revise.
Where you can find more information - Pages 3 to 4
4. Please reorganize your prospectus so that this section appears
after your "Summary" and "Risk Factors" sections.
5. Please include the name of a contact person at Bovie Medical
and
the statement required by Item 12(c)(1)(i) of Form S-3.
6. Item 12 of Form S-3 does not permit incorporation by reference
of
a previously filed Schedule 13D or proxy statement. Also, Item
12(a)(3) requires that you incorporate your Exchange Act
registration
statement. Please revise accordingly.
Risk Factors - Pages 6 to 14
7. Please revise the second and third italicized sentences of your
introduction to this section to clarify that you have included all
material risk factors. Revise your risk factors as necessary to
include a discussion of all material risks.
We conduct a significant amount of our sales - Pages 6 to 7
8. Disclose where you have material international sales and
operations. Also clarify how the generic risks in the bullet list
apply to those countries.
If we fail to attract, here and retain qualified and key
personnel - Page 11
9. Please revise the last paragraph of this risk factor to clarify
what you mean by "potential taxes."
Selling Stockholders - Pages 16 to 18
10. For each selling stockholder that is a nonpublic entity,
please
identify the natural person(s) with voting or investment control
over
the shares held by such entity. Refer to Interpretation I.60 of
Telephone Interpretation Manual (July 1997) and Interpretation 4S
of
Regulation S-K section of 3/99 Supplement to Manual.
11. Tell us whether any selling stockholder is a broker-dealer or
affiliate of a broker-dealer.
Proceeds - Page 19
12. Please clarify under what circumstances you will be reimbursed
by
the selling stockholders.
Exhibits
13. Please file a legal opinion with your next amendment.
14. We note your application for confidential treatment. We will
provide any comments on your application separately. Any comments
on
your application must be resolved before you request for
acceleration
of the effective date of this registration statement.
Annual Report on Form 10-KSB for the year ended December 31, 2003
Item 1 - Business
Jump Unipolar Low Temperature Focused Plasma Technology
15. Please direct us to where you have filed the Joint Venture
Agreement with Jump Agentur Fuer Elektrotechnik GMBH as an exhibit
to
your SEC filings. If you have not filed such agreement as an
exhibit
to your SEC filings, please provide us with your analysis as to
why
that agreement does not need to be filed as a material agreement
as
required by Item 601(b)(10) of Regulation S-B.
16. With a view toward disclosure, please tell us the percentage
you
hold of the ownership interest in the joint venture formed with
Jump
Agentur Fuer Elektrotechnik GMBH, whether this joint venture has
recognized any revenues, and how profits are allocated among the
venture partners.
New Products
17. Please direct us to where you have filed the exclusive
worldwide
license agreement with Emergency Medical Innovations, LLC as an
exhibit to your SEC filings. If you have not filed such agreement
as
an exhibit to your SEC filings, please provide us with your
analysis
as to why that agreement does not need to be filed as a material
agreement as required by Item 601(b)(10) of Regulation S-B.
Competition
18. Please expand your disclosure to describe your competitive
position in your industry and the methods by which you compete.
Please refer to Item 101(b)(4) of Regulation S-B.
Patents and Trademarks
19. Please indicate the duration of any material patents that you
hold. Refer to Item 101(b)(7) of Regulation S-B.
Item 6 - Management`s Discussion and Analysis
General
20. Please provide your critical accounting policy disclosures and
the information related to the underlying estimates and judgments
required by FR-72 and SEC Release No. 33-8350. The critical
accounting policies discussion should supplement, not duplicate,
the
description of accounting policies that are disclosed in the notes
to
the financial statements. While accounting policy notes in the
financial statements generally describe the method used to apply
an
accounting principle, the discussion in MD&A should present an
analysis of the uncertainties involved in applying a principle at
a
given time or the variability that is reasonably likely to result
from its application over time. Details should also be provided
of
the specific estimates and assumptions that are used in this
policy
and how these were determined.
Results of Operations
21. Please revise your MD&A to quantify and discuss each of the
significant factors that contributed to significant changes in
revenues and the various expenses amounts in the financial
statements. For example, you indicate that the significant
increase
in revenue relates to an increase from the sale of electrosurgery
products but do not quantify or discuss the reasons for this
increase. In addition, you also cite an increase in professional
services but do not quantify each of the specific factors or
components that contributed to the increase. Please revise to not
only quantify all significant changes but also include details of
why
these changes occurred. Additionally, if there are offsetting
factors you should quantify and discuss each of the offsetting
factors. Please apply this guidance throughout MD&A. Before
filing
your amendment, please review Interpretative Release 33-8350
(December 19, 2003) available on our Web site at
http://www.sec.gov/rules/interp/33-8350.htm.
22. Clarify which of your medical products materially contributed
to
sales. Also disclose the extent to which those contributions
varied
over the periods presented and the reasons for that variation.
23. Discuss why the cost of sales of your OEM generators
increased.
Financial Condition
24. Please revise to provide more details of the following as
required by Item 303 (b) of Regulation S-B:
a) Provide details of any purchase, sale or other material
commitments for capital expenditures and the expected source of
funds
for these expenditures;
b) Provide a summary of product research and development that you
plan to pursue for the next year and the expected funds needed for
these activities;
c) Discuss any known events that could have an impact on
continuing
operations such as the sale of your non-medical segment; and
d) Clarify whether you expect to be able to satisfy your short-
term
liquidity requirements or if you will need to raise additional
funds
in the next 12 months. All sources of internal and external
sources
of liquidity should be addressed.
25. Please revise to disclose details of significant changes in
balance sheet accounts each period in MD&A.
Item 9 - Directors, Executive Officers, Promoters and Control
Persons
26. Please provide the disclosure required by Item 401(e) and (f)
of
Regulation S-B.
27. Provide the disclosure required by Regulation S-B Items 405
and
406.
28. We note that Mr. Kozloff has not been identified as an
executive
officer of your company. Since Mr. Kozloff has been identified as
an
executive officer under Item 10, please include the disclosures
required by Item 401 for Mr. Kozloff as well.
Item 10 - Remuneration
29. Revise your disclosure to use the table format and column
headings required by Item 402 of Regulation S-B.
Item 11 - Security Ownership of Certain Beneficial Owners and
Management of Bovie
30. Please tell us how you are complying with Exchange Act Rule
16a-
3(k).
Item 13 - Exhibits and Reports on Form 8-K
31. Please conform the heading of this Item to "Exhibits" as
required
by Form 10-KSB and furnish the exhibits required by Item 601 of
Regulation S-B. For example, please file the agreements mentioned
in
the section entitled "Reliance on Collaborative, Manufacturing and
Selling Arrangements" of Item 6. In addition, please include an
exhibit index listing all of the required exhibits indicating
whether
those exhibits have been filed along with your Form 10-KSB or
whether
they have been incorporated by reference.
Item 14 - Disclosure Controls and Procedures
32. Revise this filing and your most recent quarterly report to
comply with Regulation S-B Item 307 which requires the conclusions
be
stated as of the end of the period covered by the report.
Financial Statements
Consolidated Statement of Shareholders Equity
33. Tell us the difference between "Subscription receivable paid
in
cash" and "Subscription Receivable." Also the subscription
transaction should be disclosed in the footnotes.
Consolidated Statement of Cash Flows
34. Please tell us the nature of the short term notes and where
these
are disclosed in the accounting policies.
35. Please tell us where the term loan payment and the line of
credit
payment from Note 7 are reflected in the financing activities of
the
statement of cash flows.
36. Please provide details of the inventory and parts and
development
costs write-downs included in the statement of cash flows and
indicate where these amounts have been disclosed in the footnotes.
The specific circumstances and assumptions related to these write-
downs should be clearly disclosed. If there have been any
subsequent
sales of inventory that have been written-down the impact of
theses
sales on margins should be disclosed in MD&A.
Note 1. Accounts Receivable
37. We reference the allowance for discounts in Note 3. Please
include a description of the discount policy that you use in
relation
to accounts receivable and the amount that was written-off for
each
year.
Note 1. Inventory and Repair Parts
38. Please tell us where the inventory reserves are reflected in
the
balance sheet. In addition, the reserves and write-offs each
period
should be separately disclosed in Note 1. Clarify whether these
reserves establish a new cost basis.
39. Please provide details of the reason that repair parts are
classified as a non-current asset.
Long-lived Assets
40. Please provide details of the basis for classifying trade name
as
an indefinite-lived intangible asset. In addition, provide more
details about how you evaluate and test indefinite-lived
intangibles
and goodwill for impairment.
Revenue Recognition and Product Warranty
41. Please provide more details of the revenue recognition policy
for
all significant products and services and the basis for
recognition
of revenue at shipment, including details of post-shipment
obligations, customer acceptance, rights of return, etc. and how
these impact revenue recognition. In addition, provide details of
discounts, credits and other sales incentives and clarify the
accounting treatment.
42. Please provide more details of product warranties, including
the
reconciliation of the reserve as required by FIN 45.
43. Tell us and discuss in your revised filing your revenue
recognition policy for research and development performed for
others
as noted in Note 15.
Research and Development
44. Please separately disclose the amounts of any development
costs
that are capitalized.
Note 2. Joint Venture Agreement
45. Please provide details of the ownership percentage of the
joint
venture and the related accounting treatment. Provide details of
whether the equity investment meets the requirements of Rule 4-08
(g)
of Regulation S-X for summarized financial information.
Note 5 - Due to Shareholders
46. We reference the amounts included in the financial statements
related to the recission offer made by the Company. Provide more
details of this offer and how this has been recorded in the
financial
statements.
Note 6. Intangible Assets
47. Please revise to remove indefinite lived intangible assets
(trade
name and goodwill) from those that are subject to amortization. In
addition, assets that have been fully amortized should be removed
from this table. The total in the table should also agree with
the
balance sheets.
48. Tell us why the Electrosurgery Technology, Multifunction
Cautery
and the patent rights original balances decreased or were written-
off
separate from the normal accumulated depreciation.
49. Please revise to separate the useful lives by type of
intangible
asset.
Note 8. Options
50. Please revise the "Summary of Significant Policies" footnote
to
include the required information regarding stock-based
compensation
in paragraph 2 (c) (1-5) of SFAS 148.
51. Provide details of the 1.8 million stock options granted
during
the year, including whether the price was at fair value (and how
this
was determined) and the amount of any compensation recorded.
Note 9. Taxes and Net Operating Loss Carryforwards
52. We note that the Company believes that it is possible that the
benefit of these assets may not be realized in the future,
therefore
tell us why the net current deferred tax assets have not changed
from
2002 to 2003, and why a valuation allowance has not been
established
for the entire deferred tax asset.
Note 12. Commitment and Contingencies
53. We reference the discussion in Item 1 that the Company is
responsible for securing an estimated $1.5 million in financing
for
the joint venture with the German company. Disclose details of
any
significant commitments, contingencies or guarantees with this or
any
other joint venture or from any other collaborative arrangement.
54. Provide supplemental details of whether the existing policy
for
product liability insurance that expires December 31, 2004 has
been
renewed.
Note 14. Industry Segment Reporting
55. We note that your foreign sales make up approximately 15% of
your
overall sales. Please tell us why you do not have a significant
accounting policy on accounting for foreign currency translations
and
tell us how you have accounted for foreign currency within your
current financial statements.
56. In regards to the sale of the non-medical product line, please
tell us the following:
a) How much did you obtain for the sale of the product line? How
did
you account for the gain or loss of the sale? When did the sale
occur?
b) Why did you not account for the sale of the product line as a
discontinued operation as required by SFAS 144?
c) Did you have any exit or disposal activity in relation to the
sale
of the product line? If so, how much and explain the activities
as
required by SFAS 146.
57. Demonstrate how you meet the requirements of paragraphs 25-28
of
SFAS 131. Additionally, please tell us what is included in the
"Gain
(Loss)" category and why amortization is not included in the
depreciation line item, as the depreciation and amortization
heading
should reconcile to the cash flow statement. If the gain (loss)
represents pre-tax income from the statements of operations please
revise the caption here and throughout the footnotes to use the
correct terminology.
Note 15. Research and Development
58. Please provide details of the accounting for the research and
development arrangements and the nature of arrangement with the
customer to receive a credit for its reimbursement of research and
development cost of $112,000. Clarify why these are reflected as
revenue generating activities rather than cost reimbursement
activities.
Form 10-QSB for the Period Ended September 30, 2004
General
59. Please address the above comments on the Form 10-K in your
revised filings, as applicable.
Management`s Discussion and Analysis of Financial Condition and
Results of Operations
Results of Operations
60. Please provide details of the recall of the product discussed
in
MD&A, the amounts recorded related to the recall and any
additional
costs that are expected.
61. Please clarify your disclosure about the sales tracking data
provided by distributors. What are "those areas" that were not
being
reported before? Is the increased expense a one-time event to
cover
previously unpaid obligations, or are back payments due? How did
the
previous unavailability of the data affect your analysis of your
controls and procedures?
* * *
As appropriate, please amend your registration statement in
response to these comments. You may wish to provide us with
marked
copies of the amendment to expedite our review. Please furnish a
cover letter with your amendment that keys your responses to our
comments and provides any requested supplemental information.
Detailed cover letters greatly facilitate our review. Please
understand that we may have additional comments after reviewing
your
amendment and responses to our comments.
We urge all persons who are responsible for the accuracy and
adequacy of the disclosure in the filings reviewed by the staff to
be
certain that they have provided all information investors require
for
an informed decision. Since the company and its management are in
possession of all facts relating to a company`s disclosure, they
are
responsible for the accuracy and adequacy of the disclosures they
have made.
Notwithstanding our comments, in the event the company
requests
acceleration of the effective date of the pending registration
statement, it should furnish a letter, at the time of such
request,
acknowledging that:
* should the Commission or the staff, acting pursuant to delegated
authority, declare the filing effective, it does not foreclose the
Commission from taking any action with respect to the filing;
* the action of the Commission or the staff, acting pursuant to
delegated authority, in declaring the filing effective, does not
relieve the company from its full responsibility for the adequacy
and
accuracy of the disclosure in the filing; and
* the company may not assert this action as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of
Enforcement
has access to all information you provide to the staff of the
Division of Corporation Finance in connection with our review of
your
filing or in response to our comments on your filing.
We will consider a written request for acceleration of the
effective date of the registration statement as a confirmation of
the
fact that those requesting acceleration are aware of their
respective
responsibilities under the Securities Act of 1933 and the
Securities
Exchange Act of 1934 as they relate to the proposed public
offering
of the securities specified in the above registration statement.
We
will act on the request and, pursuant to delegated authority,
grant
acceleration of the effective date.
We direct your attention to Rules 460 and 461 regarding
requesting acceleration of a registration statement. Please allow
adequate time after the filing of any amendment for further review
before submitting a request for acceleration. Please provide this
request at least two business days in advance of the requested
effective date.
You may contact Traci Hornfeck at (202) 824-5565, or Brian
Cascio, Branch Chief, at (202) 942-1791, if you have questions
regarding our comments on the financial statements and related
matters. Please contact Tim Buchmiller at (202) 824-5354 or me at
(202) 824-5697 with questions regarding our comments on any other
part of your filing.
Sincerely,
Russell Mancuso
Branch Chief
cc: Alfred V. Greco, Esq. (via fax)
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Bovie Medical Corporation
December 22, 2004
Page 11