SEC Comment Letter for CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294) (CPIX) — Jun 8, 2007
CUMBERLAND PHARMACEUTICALS INC (CPIX) (CIK 0001087294)
Date: June 8, 2007 · CIK: 0001087294 · Accession: 0000000000-07-028397
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File numbers found in text: 333-142535
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Mail Stop 6010
June 8, 2007
A.J. Kazimi
Chief Executive Officer and Chairman of the Board
Cumberland Pharmaceuticals, Inc.
2525 West End Avenue – Suite 950
Nashville, Tennessee 37203
Re: Cumberland Pharmaceuticals, Inc.
Form S-1 Registration Statement
File No. 333-142535
Dear Mr. Kazimi:
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.
Comments Applicable to the Entire Document
1. 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:
• Summary Financial Data
• Use Of Proceeds
• Capitalization • The Option Grants Table
• Shares Eligible For Future Sale
• The Principal Stockholders Table
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 2
• Dilution • 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 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.
2. 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.
3. 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.
4. Please update your interim financial statements and related financial information as required by Rule 3-12 of Regulation S-X.
Prospectus Summary
5. Please disclose your accumulated deficit.
6. 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.
7. 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.
8. Please provide third party support for your statement that NAC is accepted as the worldwide standard of care for treating acetaminophen overdose.
9. 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 you defining the market?
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 3
10. 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?
Summary Consolidated Financial Data - page 5
11. 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.
Risk Factors – page 6
12. 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.
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. 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.
14. If there have been any reports of adverse effects from these products, please specifically identify them.
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 manufactjurer and may lose
potential revenues. – page 7
15. 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, please revise the discussion to specifically state this information. Similarly, state whether you can obtain Kristalose from any party other than Inalco.
Competitive pressures could reduce our revenues and profits. – page 9
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 4
16. 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.
Our future growth depends on our ability to identify and acquire rights to products. If we4 do no
successfully identify and acquire rights to products and successfully integrate them into our
operations , our growth opportunities would be limited. – page 9
17. 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.
The size of our organization and our activities are growing, and we may experience difficulties
in managing growth. – page 11
18. It is unclear whether the number of employees disclosed includes the sales staff you recently acquired from Cardinal. Please clarify the disclosure.
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.
20. Please tell us you basis for market exclusivity for Amelior.
Use of Proceeds – page 23
21. 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.
22. 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.
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 5
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.
23. 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.
24. 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.
25. Please clarify whether you intend to use proceeds from this offering to pay the deferred portion of the purchase price for Kristalose.
Management’s Discussion and Analysis – page 28
Critical Accounting Policies and Significant Judgments and Estimates
Revenue Recognition, page 29
26. 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:
a. 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.
b. 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.
c. 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
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 6
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.
d. If applicable, any shipments made as a result of incentives and/or in excess of your customer’s ordinary course of business inventory level. Disclose your revenue recognition policy for such shipments.
e. A roll forward of the accrual for each estimate for each period presented showing the following:
• Beginning balance,
• Current provision related to sales made in current period,
• Current provision related to sales made in prior periods,
• Actual returns or credits in current period related to sales made in current period,
• Actual returns or credits in current period related to sales made in prior periods, and
• Ending balance.
f. 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.
Stock-Based Compensation, page 30
27. 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.
28. Please expand your disclosure to clarify w hy 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.
Results of Operations, page 32
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 7
General
29. 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.
Year ended December 31, 2005 compared to year ended December 31, 2004
30. 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.
31. 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.
Liquidity and Capital Resources – page 35
32. Please expand the disclosure on page 36 to include the amount of your minimum purchase obligations under your agreements with Bioniche and Kristalose.
33. 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.
Contractual Obligations, page 37
34. Please revise your table to include a total column. Please refer to Rule 303(a)(5) of Regulation S-K.
35. 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 necessary to understand your future cash requirements. Please refer to section IV of Financial Reporting Release 72.
A.J. Kazimi Cumberland Pharmaceuticals, Inc. June 8, 2007 Page 8
Quantitative and Qualitative Disclosures of Market Risks, page 38
36. 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 cer tain market risks are not material please
disclose this fact.
Business – page 39
37. Please include a discussion of the material terms of your agreements with the following parties:
• Vanderbilt University, both the intravenous ibuprofen license and the collaboration agreement;
• Mayne Pharma Pty, Ltd – for the manufacture of commercial supplies of Amelior and the license agreement;
• Bertek – exclusive rights to commercialize Kristalose;
• University of Mississippi – the collaboration agreement;
• University of Tennessee – collaboration agreement;
• Advogent Group – sales force agreement; and
• 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