Cumberland Pharmaceuticals Inc.
[A&R Letterhead]
June 22, 2007
United States Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
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Attention:
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Mr. Jeffrey P. Riedler |
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Assistant Director |
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Re:
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Cumberland Pharmaceuticals Inc. |
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Form S-1 Registration Statement |
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File No. 333-142535 |
Ladies and Gentlemen:
We are responding to comments received in a letter dated June 8, 2007 from Mr. Jeffrey P.
Riedler to Mr. A.J. Kazimi with respect to the Form S-1 Registration Statement of Cumberland
Pharmaceuticals Inc. filed on May 1, 2007. For your convenience, we have repeated in bold type the
comments and requests for additional information exactly as set forth in Mr. Riedlers letter. On
the date hereof, we have filed Amendment No. 1 to the Registration Statement reflecting all changes
discussed herein.
The following paragraphs set forth the responses of Cumberland Pharmaceuticals Inc. to the
comments contained in Mr. Riedlers letter of June 8, 2007. All page references below are to page
numbers in the Registration Statement, filed May 1, 2007, except as otherwise set forth herein. For
your convenience, a marked copy of Amendment No. 1, comparing Amendment No. 1 to the Registration
Statement, is enclosed herewith.
Comments Applicable to the Entire Document
1. |
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We note that your filing contains numerous omissions throughout the prospectus which relate
to the offering price range or the number of shares you will sell. These omissions include
but are not limited to: |
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Summary Financial Data
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The Option Grants Table |
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Use of Proceeds
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Shares Eligible for Future Sale |
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Capitalization
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The Principal Stockholders Table |
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Dilution
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Description of Capital Stock |
Rule 430A requires you to include this information in your filing based upon an estimate of
the offering price within a bona fide range you disclose on the cover page
Securities and Exchange Commission
June 22, 2007
Page 2
and based upon an estimate of the number of shares you will sell. We consider a bona fide
range to be $2 if the price is under $20 and 10% if it is above $20.
You should
include the required information in an amendment prior to circulating a red herring
prospectus.
Response:
The Company will comply with this comment by filing an amendment containing all of the
information required by Rule 430A at the time that the red herring prospectus is filed, and prior
to the road show.
2. |
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Provide us with copies of all the graphic, photographic or artistic materials you intend to
include in the prospectus prior to its printing and use. Please note that we may have
comments. Please also note that all textual information in the graphic material should be
brief and comply with the plain English guidelines regarding jargon and technical language. |
Response:
By separate cover, the Company is providing the Commission Staff copies of the graphic
materials that the Company proposes to include in the prospectus.
3. |
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Comments on your application for confidential treatment will follow under separate cover. We
will not consider a request for acceleration of effectiveness of the registration statement
until any comments we may have on the application are resolved. |
Response:
We will await receipt of your comments regarding the Companys request for confidential
treatment of certain proprietary information.
4. |
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Please update your interim financial statements and related financial information as required
by Rule 3-12 of Regulation S-X. |
Response:
The Company has complied with this comment by updating the interim financial statements and
related financial information in Amendment No. 1 to include financial statements as of March 31,
2007 and covering the three months ended March 31, 2006 and March 31, 2007.
Securities and Exchange Commission
June 22, 2007
Page 3
Prospectus Summary
5. |
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Please disclose your accumulated deficit. |
Response:
The Company has complied with this comment by inserting in the tables on pages 5 and 27 of the
Registration Statement (pages 5 and 30 of Amendment No. 1) an accumulated deficit line item as of March 31, 2007 of $6,620,820.
6. |
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Please revise your statement that you expect Amelior to be the first injectable product
approved for pain and fever. You should not assume you will receive FDA approval. Similarly,
revise page 45. |
Response:
The Company has complied with this comment by deleting the fourth full paragraph on page 1 and
substituting, in lieu thereof, a revised paragraph (page 1 of Amendment No. 1). Corresponding
changes have been made on page 39 (page 47 of Amendment
No. 1) and page 45 (page 53 of Amendment No. 1).
7. |
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Please delete the statement that you believe Amelior is a safe and effective treatment.
Safety and efficacy is still being tested and are determinations made by the FDA. |
Response:
The Company has complied with this comment by deleting the sentence as requested.
8. |
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Please provide third party support for your statement that NAC is accepted as the worldwide
standard of care for treating acetaminophen overdose. |
Response:
In making this assertion, the Company is relying in part on an article, entitled An update of
N- acetylcysteine treatment for acute acetaminophen toxicity in children by Laurie Marzullo,
published by Lippincott Williams & Wilkins, Curr Opin Pediatr 17:239-245, 2005. On page 240, Ms.
Marzullo states that The accepted antidote for ingestion of toxic levels of acetaminophen is N-
acetylcysteine (NAC), as published by Prescott et al.
The
Company is furnishing to the Commission Staff a copy of the article
by separate cover. Other articles support the Companys position that NAC is the protocol for
treatment of acetaminophen overdose. If the Commission Staff would like supplemental support for
this position, we would be happy to supply additional support at its request.
Securities and Exchange Commission
June 22, 2007
Page 4
9. |
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Please provide your basis for your belief that you can continue to expand your market share
of Acetadote. Since Acetadote is the only intravenous formulation of N-acetylcysteine, how
are your defining the market? |
Response:
The Company defines the market for Acetadote to include users of both the intravenous
formulation and the oral formulation of N-acetylcysteine, or NAC. According to a survey by the
American Association of Poison Control Centers Toxic Exposure Surveillance System, approximately
66% of people treated with NAC in 2005 were given an oral formulation. This survey is not
comprehensive of total NAC use in the U.S. and the Company believes that oral NAC was used in an
even greater percent of cases nationwide during that year based on an internal analysis of oral NAC
sales from data provided by Wolters Kluwer. The Company believes that intravenously administered
Acetadote has clinical and financial benefits relative to orally administered NAC, including ease
of administration, minimizing nausea and vomiting associated with oral NAC, accurate dosage
control, shorter treatment protocol and reduction in overall cost of acetaminophen overdose
management, as discussed on page 47 of the Registration Statement
(page 55 of Amendment No. 1). The Company believes that Acetadote also offers significant
cost advantages to both patients and hospitals by reducing the treatment regimen, usually from
three days to one day. For these reasons, the Company feels that the use of Acetadote will
continue to grow as patients and hospitals increasingly favor Acetadote over orally administered
NAC.
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We note your discussion related to early-stage product candidates, please clarify what you
meant by early-stage. For example, do you mean are these products in pre-clinical trials,
Phase I trials, or have they not yet reached the pre-clinical trial stage? |
Response:
The Company has complied with this comment by amending the first sentence of the fourth full
paragraph on page 2 (page 2 of Amendment No. 1). Additionally, the Company has complied with
this comment by amending similar language on page 40 (page 48 of Amendment No. 1).
Summary Consolidated Financial Data page 5
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Please provide pro forma net income per share amounts for the most recent fiscal year and
interim period to give effect to the conversion of preferred stock into common stock. Please
refer to Rule 11-01(a) of Regulation S-X. |
Response:
Securities and Exchange Commission
June 22, 2007
Page 5
The Company has complied with this comment by including pro forma net income per share
information in the table on page 5 (page 5 of Amendment No. 1).
Risk Factors page 6
12. |
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Please revise the introductory paragraph to eliminate the reference to other unforeseen
risks. You should not caution against risks that are not identified and described. |
Response:
The Company has complied with this comment by amending the introductory paragraph on page 6
(page 6 of Amendment No. 1) to delete the third sentence.
We currently market two products, Acedote and Kristalose. An adverse development regarding
either of these products could have a material and adverse impact on us. page 7
13. |
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This discussion is too broad. Please revise this risk factor to more specifically identify
the types of changes that could have and adverse impact and the likely impact. |
Response:
The Company has complied with this comment by deleting the existing risk factor and replacing
it with a revised risk factor on page 7 (page 7 of Amendment No. 1).
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If there have been any reports of adverse effects from these products, please specifically
identify them. |
Response:
The
Company has complied with this comment by inserting a new
paragraph at the end of the risk
factor described in Comment No. 13.
If any manufacturer we rely on fails to produce our products and product candidates in the
amounts we require on a timely basis, or fails to comply with stringent regulations applicable to
pharmaceutical drug manufacturers, we may face delays in the commercialization of Amelior, or may
be unable to meet demand for the product supplied by the manufacturer and may lose potential
revenues. page 7
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Does your agreement with Bioniche allow you to obtain Acetadote from another source if they
are unable to supply sufficient quantities of Acetadote? If it does not, |
Securities and Exchange Commission
June 22, 2007
Page 6
please revise the discussion to specifically state this information. Similarly, state
whether you can obtain Kristalose from any party other than Inalco.
Response:
The Companys agreement with Bioniche allows the Company to obtain Acetadote from another
source if Bioniche is unable to supply sufficient quantities of Acetadote. The Companys agreement
with Inalco does not expressly authorize the Company to obtain Kristalose from a party other than
Inalco if Inalco is unable to supply sufficient quantities of Kristalose. Accordingly, the Company
has complied with this comment by revising the language in the risk
factor on page 7 (page 8 of
Amendment No. 1).
Competitive pressures could reduce our revenues and profits. page 9
16. |
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Please revise the risk factor to identify the two competing laxative products and their
manufacturers as well as the identity of the company developing the intravenous acetaminophen
product. |
Response:
The Company has complied with this comment by revising the second paragraph of this risk
factor as set forth on page 9 (page 9 of Amendment No. 1).
Our future growth depends on our ability to identify and acquire rights to products. If we do
not successfully identify and acquire rights to products and successfully integrate them into our
operations, our growth opportunities would be limited. page 9
17. |
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In the last paragraph of this risk factor you indicate that you are not precluded from
engaging in a large acquisition in the future, including an acquisition that entails the
investment of substantially all of the proceeds from this offering. Please disclose whether
you are currently contemplating, discussing or negotiating an acquisition. If so, you should
provide appropriate disclosure in the relevant places in the prospectus, including the Use of
Proceeds section. If you do not have such plans, please state that you have no current
acquisition plans. |
Response:
The Company advises the Commission Staff that while we continually screen and evaluate
potential acquisitions of product candidates, intellectual property
rights or companies that complement our business, we have no current
commitments or agreements for such acquisitions. The Company has
stated this on page 10 of Amendment No. 1.
The size of our organization and our activities are growing, and we may experience difficulties
in managing growth. page 11
Securities and Exchange Commission
June 22, 2007
Page 7
18. |
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It is unclear whether the number of employees disclosed includes the sales staff you recently
acquired from Cardinal. Please clarify the disclosure. |
Response:
The Company has complied with this comment by amending the first sentence of this risk factor
as set forth on page 11 (page 12 of Amendment No. 1).
Our strategy to secure and extend marketing exclusivity or patent rights may provide only
limited protection from competition. page 14
19. Please explain what the terms priority filing date and orphan drug mean.
Response:
The Company has complied with this comment by eliminating the reference to the technical term
priority filing date and has amended the third sentence
of the last paragraph on page 14 (page 15 of Amendment No. 1) and has added an additional explanatory paragraph regarding orphan drug
designation.
We refer the Commission Staff to the Orphan Drug Designation paragraph under the Business
section on page 57 (page 66 of Amendment No. 1) for a full explanation of orphan drug designation.
20. Please tell us you basis for market exclusivity for Amelior.
Response:
The Company is basing its claim for market exclusivity for Amelior upon the Hatch-Waxman Act,
which provides three years of marketing exclusivity for the approval of new and supplemental NDAs,
including Section 505(b)(2) NDAs, for, among other things, new indications, dosages or strengths of
an existing drug, if new clinical investigations that were conducted or sponsored by the applicant
are essential to the approval of the application. The Company explains this legal provision in
paragraph 1 on page 58 (page 66 of Amendment No. 1) entitled The Hatch-Waxman Act under the Business section of the Registration
Statement.
Use of Proceeds page 23
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Please expand the disclosure in this section to identify the amount of proceeds you intend to
spend on each identified purpose. Also, please be more specific about what the purposes are. |
Response:
Securities and Exchange Commission
June 22, 2007
Page 8
The Company has complied with this comment by deleting the second paragraph of the Use of
proceeds section on page 23 and replacing it with several
additional paragraphs (page 24 of
Amendment No. 1).
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You say that you may use a portion of the proceeds for product development and expansion.
Please identify the products you intend to develop with proceeds from this offering. Disclose
the amount of proceeds you intend to spend on development of each product and discuss how far
along in the development process the proceeds will take you. Disclose the amount of
additional funds you anticipate will be necessary to complete development and market the
product. If additional funds will be required disclose the source you anticipate obtaining
the funds from, as well as the timeframe involved in completing the development process. |
Response:
The
Company hereby advises the Commission Staff that it intends to utilize approximately $4
million of the net proceeds for the continued clinical testing and product development of Amelior.
While the Company cannot predict with certainty the amounts required to be spent for this purpose,
the Company expects its existing capital resources and the net proceeds from this offering to be
sufficient to fund the completion of the clinical development programs of Amelior through
commercial introduction of the product to the U.S. market, assuming the Companys clinical programs
progress in accordance with its plans.
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Disclose the amount of indebtedness you have and the amount you intend to repay using
proceeds from this offering. Also disclose the uses of the borrowed funds. Please refer to
the instructions to Item 504 of Regulation S-K. |
Response:
The amount of the Companys indebtedness is set forth in the balance sheet tables throughout
the Registration Statement. As of March 31, 2007, the aggregate principal due under the Companys
line of credit and term loan was $4,950,949. Currently, the Company does not intend to use the
proceeds of this offering to repay its indebtedness; therefore, the
Company believes disclosure in the Use of proceeds
section is not relevant.
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You indicate that you may use proceeds from this offering to finance acquisitions. Identify
the business or product you intend to acquire, if known, or if not known, the nature of the
business or other acquisitions to be sought, the status of any negotiations with respect to
the acquisition and a brief discussion of the business. |
Response:
The
Company has complied with this comment by including a new second paragraph in the Use of proceeds
section of the Registration Statement (page 24 of Amendment
No. 1).
Securities and Exchange Commission
June 22, 2007
Page 9
25. |
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Please clarify whether you intend to use proceeds from this offering to pay the deferred
portion of the purchase price for Kristalose. |
Response:
The Company currently does not intend to use proceeds from this offering to pay the deferred
portion of the purchase price for Kristalose.
Managements Discussion and Analysis page 28
Critical Accounting Policies and Significant Judgments and Estimates
Revenue Recognition, page 29
26. |
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We believe that your disclosure related to estimates that reduce gross revenue such as
chargebacks, discounts, rebates and product returns could be improved. Please revise your
disclosure and include the following: |
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The nature and amount of each accrual at the balance sheet date and the
effect that could result from using other reasonably likely assumptions than what
you used to arrive at each accrual such as a range of reasonably likely amounts or
other type of sensitivity analysis. |
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b. |
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The factors that you consider in estimating each accrual such as
historical return of products, levels of inventory in the distribution channel,
estimated remaining shelf life, price changes from competitors and introductions of
generics and/or new products. |
Response:
The Company has complied with Comments No. 26(a) and 26(b) by revising the section entitled
Revenue Recognition on page 29 of the Registration Statement
(pages 32-33 of Amendment No. 1).
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To the extent that information you consider in b) is quantifiable,
disclose both quantitative and qualitative information and discuss to what extent
information is from external sources, such as end-customer prescription demand,
third-party market research data comparing wholesaler inventory levels to
end-customer demand. For example, in discussing your estimate of product that may
be returned, explain, preferably by product and in tabular format, the total amount
of product in sales dollars that could potentially be returned as of the balance
sheet date and disaggregated by expiration period. |
Securities and Exchange Commission
June 22, 2007
Page 10
Response:
The Company has complied with Comment No. 26(c) by amending the section entitled Revenue
Recognition on page 29 of the Registration Statement (pages 32-33 of Amendment No. 1).
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If applicable, any shipments made as a result of incentives and/or in
excess of your customers ordinary course of business inventory level. Disclose
your revenue recognition policy for such shipments. |
Response:
The Company has complied with Comment No. 26(d) by amending the section entitled Revenue
Recognition on page 29 of the Registration Statement (pages 32-33 of Amendment No. 1).
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A roll forward of the accrual for each estimate for each period
presented showing the following: |
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Beginning balance, |
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Current provision related to sales made in current period, |
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Current provision related to sales made in prior periods, |
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Actual returns or credits in current period related to sales made in current
period, |
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Actual returns or credits in current period related to sales made in prior
periods, and |
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Ending balance. |
Response:
The Company believes it has adequately addressed the information requested in its additional
disclosures for Comment No. 26 (b) and (c).
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f. |
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Regarding your discussion of results of operations for the period to
period net sales comparisons, the amount of and reason for fluctuations for each
type of reduction of gross sales, i.e. product returns, rebates and discounts,
including the effect that changes in your estimates of these items had on your net
sales and operations. |
Response:
The Company has complied with Comment No. 26(f) by revising the Net revenues discussion in
the Managements discussion and analysis of financial condition and results of operations section
entitled Year ended December 31, 2006 compared to year ended December 31, 2005 on page 33 of the
Registration Statement (page 39 of Amendment No. 1).
Securities and Exchange Commission
June 22, 2007
Page 11
In addition, the Company has revised the Net revenues discussion in the Managements
discussion and analysis of financial condition and results of operations section of the section
entitled Year ended December 31, 2005 compared to year ended December 31, 2004 on page 34 of the
Registration Statement (page 40 of Amendment No. 1).
Stock Based Compensation, page 30
27. |
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Please disclose the approach used to determine your enterprise value at each grant date and
the method used to allocate enterprise value to the outstanding equity to determine the fair
value of the underlying common stock. Disclose whether or not the valuation used to determine
the fair value of the equity instruments was contemporaneous or retrospective. |
Response:
The Company has complied with Comment No. 27 by amending the section entitled Stock-Based
Compensation on page 30 of the Registration Statement (page 34 of Amendment No. 1).
28. |
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Please expand your disclosure to clarify why you reviewed the historical volatility of
similar public companies to determine your expected volatility. Disclose the factors
considered to determine which public companies were similar. Tell us on a supplemental basis
the names of the similar public companies used to estimate expected volatility. |
Response:
The Company has complied with Comment No. 28 by amending the section entitled Stock-Based
Compensation on page 30 of the Registration Statement (pages 34-35 of Amendment No. 1).
By separate cover, the Company is providing the Commission Staff the names of the public
companies it considers to be its peers.
Results of Operations, page 32
General
29. |
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In certain areas of your disclosures, such as your discussion of net revenues, you make
references to specific factors that contributed to the change from period to period. Please
revise your disclosures to quantify each factor that resulted in significant increases or
decreases in financial statement line items. Refer to Financial Reporting Codification
Section 501.04. |
Securities and Exchange Commission
June 22, 2007
Page 12
Response:
The Company has complied with Comment No. 29 by amending the Net revenues discussion in the
Managements discussion and analysis of financial condition and results of operations section
entitled Year ended December 31, 2006 compared to year ended December 31, 2005 on page 33 of the
Registration Statement (page 39 of Amendment No. 1).
The Company has complied with Comment No. 29 by amending the Cost of products sold paragraph
of the Managements discussion and analysis of financial condition and results of operations
section entitled Year ended December 31, 2006 compared to year ended December 31, 2005 on page 33
of the Registration Statement (page 39 of Amendment No. 1).
Furthermore, the Company has complied with Comment No. 29 by amending the Selling and
marketing paragraph of the Managements discussion and analysis of financial condition and results
of operations section entitled Year ended December 31, 2006 compared to year ended December 31,
2005 on page 33 of the Registration Statement (page 39 of Amendment No. 1).
The Company has also amended the Research and development paragraph of the Managements
discussion and analysis of financial condition and results of operations section entitled Year
ended December 31, 2006 compared to year ended December 31, 2005 on page 33 of the Registration
Statement (page 39 of Amendment No. 1).
The Company has amended the General and administrative paragraph of the Managements
discussion and analysis of financial condition and results of operations section entitled Year
ended December 31, 2006 compared to year ended December 31, 2005 on page 33 of the Registration
Statement (pages 39-40 of Amendment No. 1).
The Company has amended the Interest expense paragraph of the Managements discussion and
analysis of financial condition and results of operations section entitled Year ended December 31,
2006 compared to year ended December 31, 2005 on page 34 of
the Registration Statement (page 40
of Amendment No. 1).
The Company has amended the Net revenues paragraph of the Managements discussion and
analysis of financial condition and results of operations section entitled Year ended December 31,
2005 compared to year ended December 31, 2004 on page 34 of
the Registration Statement (page 40 of Amendment No. 1).
The Company has amended the Cost of products sold paragraph of the Managements discussion
and analysis of financial condition and results of operations section entitled Year ended December
31, 2005 compared to year ended December 31, 2004 on page 34
of the Registration Statement (page 40 of Amendment No. 1).
Securities and Exchange Commission
June 22, 2007
Page 13
The Company has amended the Selling and marketing paragraph of the Managements discussion
and analysis of financial condition and results of operations section entitled Year ended December
31, 2005 compared to year ended December 31, 2004 on page 34
of the Registration Statement (page 41 of Amendment No. 1).
The Company has amended the Research and development paragraph of the Managements
discussion and analysis of financial condition and results of operations section entitled Year
ended December 31, 2005 compared to year ended December 31, 2004 on page 34 of the Registration
Statement (page 41 of Amendment No. 1).
The Company has amended the General and administrative paragraph of the Managements
discussion and analysis of financial condition and results of operations section entitled Year
ended December 31, 2005 compared to year ended December 31, 2004 on pages 34 and 35 of the
Registration Statement (page 41 of Amendment No. 1).
The Company has amended the Interest income paragraph of the Managements discussion and
analysis of financial condition and results of operations section entitled Year ended December 31,
2005 compared to year ended December 31, 2004 on page 35 of
the Registration Statement (page 41 of Amendment No. 1).
Finally, the Company has amended the Interest expense paragraph of the Managements
discussion and analysis of financial condition and results of operations section entitled Year
ended December 31, 2005 compared to year ended December 31, 2004 on page 35 of the Registration
Statement (page 41 of Amendment No. 1).
Year ended December 31, 2005 compared to year ended December 31, 2004
30. |
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You disclose that the decrease in net revenues in 2005 was primarily due to promotional costs
owed to a wholesaler. Please clarify why you recorded these costs as a reduction of revenue.
If the decrease was primarily a result of an increase in product promotion and fee service
costs, please discuss why these fees increased in 2005 over 2004. |
Response:
The Company has complied with Comment No. 30 by amending the Net revenues paragraph of the
Managements discussion and analysis of financial condition and results of operations section
entitled Year ended December 31, 2005 compared to year ended December 31, 2004 on page 34 of the
Registration Statement (page 40 of Amendment No. 1).
31. |
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Your financial statements show a gain on an insurance recovery in 2004. Please expand your
disclosure to discuss the facts and circumstance surrounding this insurance recovery. |
Securities and Exchange Commission
June 22, 2007
Page 14
Response:
The Company has complied with Comment No. 31 by adding the following Gain on insurance
recovery paragraph between the General and administrative and Interest income paragraphs of
the Managements discussion and analysis of financial condition and results of operations section
entitled Year ended December 31, 2005 compared to year ended December 31, 2004 on page 35 of the
Registration Statement (page 41 of Amendment No. 1).
Liquidity and Capital Resources page 35
32. |
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Please expand the disclosure on page 36 to include the amount of your minimum purchase
obligations under your agreements with Bioniche and Kristalose. |
Response:
The Company has complied with this comment by deleting the fourth and fifth paragraphs on page
36 of the Registration Statement, and replacing those paragraphs
with a new paragraph (page 42 of Amendment No. 1).
33. |
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Please name the third party referenced in the first paragraph of page 37, identify the
specific pharmaceutical drug and disclose the maximum aggregate amount you could be required
to pay pursuant to this agreement. |
Response:
The Company has complied with Comment No. 33 by amending the first paragraph on page 37 of the
Registration Statement (page 43 of Amendment No. 1).
Contractual Obligations, page 37
34. |
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Please revise your table to include a total column. Please refer to Rule 303(a)(5) of
Regulation S-K. |
Response:
The Company has complied with this comment by including a total column in the Contractual
Obligations section on page 37 (page 44 of Amendment No. 1).
35. |
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It appears that scheduled interest payments on long-term debt are excluded from the table.
Please revise the table to include scheduled interest payments or disclose and explain to us,
why interest payments are excluded. If you believe that interest payments should be excluded
from the table, please expand your liquidity and capital resources disclosures to discuss the
amount and timing of interest payments |
Securities and Exchange Commission
June 22, 2007
Page 15
necessary to understand your future cash requirements. Please refer to section IV of
Financial Reporting Release 72.
Response:
The Company has complied with this comment by including a row in the contractual obligations
table on page 37 (page 44 of Amendment No. 1) to show scheduled interest payments on its long-term debt.
Quantitative and Qualitative Disclosures of Market Risks, page 38
36. |
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It appears that your term loan and revolving line of credit are subject to interest rate
risk. Also you do not appear to provide any quantitative or qualitative disclosure regarding
your foreign currency exchange rate risk. Please provide the disclosures required by Rule 305
of Regulation S-K. If you believe certain market risks are not material please disclose this
fact. |
Response:
The Company has complied with this comment by deleting the paragraphs under the section
entitled Quantitative and Qualitative Disclosure of Market Risks on page 38 of the Registration
Statement, and replacing the paragraphs with revised paragraphs (pages
45-46 of Amendment No. 1).
Business page 39
37. |
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Please include a discussion of the material terms of your agreements with the following
parties: |
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Vanderbilt University, both the intravenous ibuprofen license and the
collaboration agreement; |
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Mayne Pharma Pty, Ltd for the manufacture of commercial supplies of
Amelior and the license agreement; |
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Bertek exclusive rights to commercialize Kristalose; |
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University of Mississippi the collaboration agreement; |
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University of Tennessee collaboration agreement; |
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Advogent Group sales force agreement; and |
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Alveda Pharmaceuticals license agreement |
The discussion should include each parties rights and obligations, amounts paid/received to
date, existence of royalty provisions, amounts paid/received to date, aggregate potential
milestone payments; duration and termination provisions and any other material terms. To
the extent these agreements have not been filed, please file them or provide us with an
analysis supporting your determination that you are not substantially dependent on them.
Securities and Exchange Commission
June 22, 2007
Page 16
Response:
To comply with Comment No. 37 with regard to discussion of Vanderbilt, the Company has added
an additional sentence to the end of the final paragraph on page 45
(page 54 of Amendment No. 1).
The Company has requested confidential treatment of all payment information in the agreement with
Vanderbilt.
We do not consider our collaboration agreements with Vanderbilt University, the
University of Mississippi and the University of Tennessee, which relate to our subsidiary, CET, to
be material to our business at this time. To date, we have not
incurred any material expenses for research and development of
products related to these collaborations. All such products are at
the pre-clinical stage of development, and we do not foresee incurring
material expenses for these collaborations in the near term.
To
comply with Comment 37 with respect to agreements with Mayne Pharma
Pty. Ltd., the Company has added additional language to the section entitled
Manufacturing regarding the Companys payments to Mayne
on page 51 (pages 59-60 of Amendment No. 1).
We hereby notify the Commission that we do not consider our agreement with Mayne Pharma (SEA) Pte
Limited to market and distribute Amelior in Southeast Asia to be material to our business at this
time. Amelior has not yet received regulatory approval for marketing and distribution in Southeast
Asia, and it may never receive regulatory approval in Southeast Asia.
With respect to discussion of its agreement with Bertek, the Company has complied with Comment
No. 37 by amending the second paragraph of the section entitled Kristalose on page 47 of the
Registration Statement (page 56 of Amendment No. 1). Cumberland Pharmaceuticals further advises
the Commission Staff that it and Mylan Bertek Pharmaceuticals Inc. f/k/a Bertek Pharmaceuticals
Inc. entered into a mutual release on April 10, 2006 and have no ongoing contractual relationship.
With respect to discussion of the agreement with Advogent Group, we hereby notify the
Commission Staff that the legal name of the counterparty to this agreement currently is Inventiv
Commercial Services, LLC, and this agreement is subject to a request for confidential treatment.
We hereby notify the Commission that we do not consider our agreement with Alveda
Pharmaceuticals to market and distribute Amelior in Canada to be material to our business at this
time. Canadian regulatory authorities have not issued approval for marketing of Amelior in Canada
and may never issue such regulatory approval.
Overview page 39
38. |
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In the first paragraph you state that you have established a product development and
commercial operating infrastructure that is scalable to accommodate our expected growth. It
is unclear what this statement means. Please revise the discussion accordingly. We may have
additional comments. |
Response:
The Company has complied with this comment by amending the first paragraph under the heading
Overview on page 39 (page 47 of Amendment No. 1).
Securities and Exchange Commission
June 22, 2007
Page 17
The Company has also amended the paragraph under the heading Our Company on page 1 of the
Registration Statement with the same amended language (page 1 of Amendment No. 1).
39. |
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In the last paragraph on page 39, it is unclear whether IMS Health is the source for all the
statistical information or just the statement about the growth in the use of ketorolac.
Please clarify. If IMS Health is not the source of the other statistical information, please
revise to identify the other sources. Similarly revise the last paragraph on page 40. |
Response:
The
Company has complied with this comment by amending the last paragraph
on page 39 (page 47 of Amendment No. 1).
The Company has also complied with this comment by amending the first paragraph on page 40
(page 48 of Amendment No. 1).
40. |
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Please revise the identify the competitive advantages you believe Kristalose has over
competing prescription laxatives. |
Response:
The
Company has complied with this comment by revising the language on
page 40 (page 48 of
Amendment No. 1).
We
supplementally refer the Commission Staff to the first full paragraph
on page 48 (page 56 of Amendment No. 1), which discusses the competitive advantages of Kristalose in further
detail.
41. |
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In the third full paragraph on page 40 you indicate that you have obtained grant funding to
support the development of several early-stage product candidates. Please disclose and
discuss the source and amount of these grants and the purposes to which they are to be put. |
Response:
The
Company has complied with this comment by revising the language on
page 40 (page 48 of
Amendment No. 1).
42. |
|
To the extent you are aware of any adverse effects of any of your products or your product
candidate, please describe them. |
Response:
Securities and Exchange Commission
June 22, 2007
Page 18
Please refer to our response to Comment No. 14, in which the Company addresses any adverse
effects of its products.
Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm, page F-2
43. |
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Please have KPMG LLP identify the city and State where the report was issued in accordance
with Article 2-02 of Regulation S-X. |
Response:
The Company has complied with this comment by amending page F-2 to insert Nashville,
Tennessee as the city and state where the report was issued by KPMG LLP.
Consolidated Statements of Income, page F-4
44. |
|
Please revise your presentation of other income and expense to clearly indicate which amounts
have a negative attribute. Please refer to Rule 4-01(c) of Regulation S-X. |
Response:
The Company has complied with this comment by revising its presentation in the Consolidated
Statements of Income to clearly indicate interest expense and other expenses, which indicates their
negative attribute.
Notes to Consolidated Financial Statements
(2) Significant Accounting Policies
45. |
|
It appears that you have not provided any segment disclosures as required by SFAS 131. If
you believe you have a single reportable segment, please disclose this fact and disclose the
factors used to identify your single reportable segment as required by paragraph 26(a) of SFAS
131. Please disclose revenue by product as required by paragraph 37 of SFAS 131 and
information about major customers as required by paragraph 39 of SFAS 131. |
Response:
The Companys only reportable segment is the pharmaceutical prescription products. The Company
complied with this comment by inserting a paragraph on page F-7 of
the Registration Statement (page F-7 of Amendment No. 1) in
addition to the disclosure set forth on the top of page F-26 (page
F-28 of Amendment No. 1).
Securities and Exchange Commission
June 22, 2007
Page 19
The
Company also complied with this comment by inserting tables addressing the Companys net
revenues and Companys co-promotion revenues on page F-10 of the
Registration Statement (page F-11 of Amendment No. 1).
Supplementally, we refer the Commission staff to footnote 14 in the notes to the consolidated
financial statements.
(b) Accounts Receivable, F-7
46. |
|
Your disclosure that product revenue is recognized when the shipment is received by the
customer appears to be inconsistent with your revenue recognition policy definition of
delivery on page 29. Please revise your disclosure here and in Note 2(h) to clarify when
delivery has occurred in order to recognize revenue. |
Response:
The Company has complied with this Comment No. 46 by amending the first full paragraph on page
F-8 (second full paragraph on page F-8 of Amendment No. 1).
The Company has also complied with this Comment No. 46 by amending the last paragraph on page
F-9 and the continuation of that paragraph on page F-10 (page F-10 of Amendment No. 1).
(7) Income Taxes, page F-19
47. |
|
It appears that your deferred tax benefit for 2005 and 2006 consists solely of adjustments to
the beginning-of-the-year balance of the valuation allowance due to a change in judgment about
the realizability of deferred tax assets. Based on your disclosure in Schedule II
Valuation and Qualifying Accounts it appears that part of the change in the valuation
allowance was due to the utilization of deferred tax assets. Please revise to disclose the
significant components of your income tax benefit for each period presented or tell us how
your disclosure complies with paragraph 45 of SFAS 109. Please expand your disclosure to
describe the nature of the permanent differences listed in your 2004 tax reconciliation. |
Response:
The Company has complied with this Comment No. 47 by inserting language at the end of the
table at the top of page F-20 (page F-21 of Amendment No. 1).
The
Company also complied with this Comment No. 47 by inserting
language on page F-20 (page F-21 of Amendment No. 1).
Securities and Exchange Commission
June 22, 2007
Page 20
(8) Shareholders Equity, page F-21
48. |
|
In order for us to fully understand the equity fair market valuations reflected in your
financial statements, please provide an itemized chronological schedule covering all equity
instruments issued since January 1, 2006 through the date of your response. Please provide
the following information separately for each equity issuance: |
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a. |
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The date of the transaction; |
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b. |
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The number of shares/options issued/granted; |
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c. |
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The exercise price or per share amount paid; |
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f. |
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The identity of the recipient, indicating if the recipient was a
related party; |
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g. |
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Nature and terms of concurrent transactions; and,
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h. |
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The amount of any compensation or interest expense element. |
Response:
By separate cover, the Company is providing the Commission Staff a chronological schedule
covering all equity instruments issued by the Company since January 1, 2006.
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d. |
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Managements fair market value per share estimate and how the estimate
was made; |
The Company addresses this comment in its additional disclosure set forth in response to
Comments No. 27 and 28 hereof.
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e. |
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An explanation of how the fair value of the convertible preferred stock
and common stock relate, given the one for one conversion ratio; |
Response:
The Company has not issued equity securities involving Series A convertible preferred stock
since January 2002. The preferences of the Series A preferred stock relative to common stock are
generally based on liquidation rights of $3.25 per share and rights to reduce dilution in the event
the Company issues additional equity securities at a purchase price of less than $3.25 per share.
With respect to other rights, such as voting rights and dividend rights, preferred shareholders
generally do not have any preference in rights over common shareholders.
Progressively bridge managements fair market value determinations to the current estimated
IPO price range. Please reconcile and explain the differences between the mid-point of your
estimated offering price range and the fair values included in your analysis. Provide us
with a chronology of events leading to the filing of your IPO including when discussions
began with potential underwriters. If you do not
Securities and Exchange Commission
June 22, 2007
Page 21
have an estimated offering price in your next filing we are deferring evaluation of
stock-based compensation until your estimated offering price is specified and may have
further comment in this regard.
Response:
The
Company plans to respond to the Staffs comment early next week,
at which time the Company and the underwriters will have a better
sense of valuation.
Part II
Item 15
49. |
|
Please disclose the factual basis for exemption for each transaction identified. |
Response:
The Company has complied with this comment by including several additional paragraphs at the
end of Item 15 as page II-2 in Part II of Amendment No. 1 to the Registration Statement.
If you have any additional questions, please call the undersigned at (615) 259-1479.
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Sincerely yours,
/s/ Martin S. Brown, Jr.
Martin S. Brown, Jr.
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cc:
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Mary K. Fraser, Esq., United States Securities and Exchange Commission |
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A.J. Kazimi, Cumberland Pharmaceuticals Inc. |
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Donald J. Murray, Esq., Dewey Ballantine LLP, Counsel to the underwriters |