Marc A. Recht
T: +1 617 937 2316
mrecht@cooley.com
January 29, 2014
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn: Suzanne Hayes, Assistant Director
Re: Eagle Pharmaceuticals, Inc.
Registration Statement on Form S-1
CIK No. 0000827871
Dear Ms. Hayes:
On behalf of Eagle Pharmaceuticals, Inc. (the Company) and in connection with the Companys Registration Statement on Form S-1 (File No. 333-192984), originally confidentially submitted with the Securities and Exchange Commission (the Commission) on October 21, 2013 and originally filed by the Company with the Commission on December 20, 2013 (the Registration Statement), we submit this letter to the staff (the Staff) in response to the Staffs comments by letter dated January 27, 2014 (the Comment Letter) and supplemented by telephonic discussion with James Rosenberg, Senior Staff Accountant, and Sasha Parikh, both from the Commission on the morning of January 28, 2014 (together with the Comment Letter, the Comments).
The numbering of the paragraphs below corresponds to the numbering in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Except where otherwise indicated, page references in the text of the responses below correspond to the page numbers of our Registration Statement on Form S-1 publicly filed on January 28, 2014. We are addressing only those comments from the Comment Letter that remain outstanding as of the date hereof.
Staff Comments and Company Responses
Results of Operations
Comparison of Three Months Ended December 31, 2013 and 2012
Cost of Revenues, page 63
1. Please disclose the reasons for the significant increase in cost of revenue as a percentage of total revenue for the three months ended December 31, 2013 as compared to the year ended September 30, 2013. In this regard, discuss separately
500 BOYLSTON STREET, BOSTON, MA 02116-3736 T: (617) 937-2300 F: (617) 937-2400 WWW.COOLEY.COM
cost of revenue related to product sales versus royalty income, and quantify the amount attributed to each significant reason. As applicable, disclose the expected effect of any known events, commitments, trends or uncertainties on future results of operations.
Response: In response to the Staffs Comments, the Company will reflect in a free-writing prospectus and in a pre-effective amendment to the Registration Statement on page 63 the reasons for the significant increase in cost of revenue as a percentage of total revenue. The disclosure will be substantially consistent with the following:
Of the $4.4 million increase in cost of net revenues related to argatroban, approximately $2.4 million was attributable to increased product sales and approximately $2.0 million was attributable to royalty expense. Of the $2.0 million attributable to royalty expense, approximately $1.2 million was related to payables to SciDose and $0.8 million was related to payables to The Medicines Company under our agreements with those parties.
With respect to product sales, we experienced increased demand for the amount of product from our marketing partners in the quarter ended December 31, 2013 which resulted in an increase in the cost of revenue during that quarter. The volume of product delivered in the quarter ended December 31, 2013 increased by approximately 40% from the quarter ended September 30, 2013.
The significant increase in cost of revenue relating to royalty expense during the quarter ended December 31, 2013 is primarily attributable to the increased royalty expense related to our revenue sharing arrangement with SciDose. Under the terms of our agreement with SciDose, we retain all revenue from the sale of a product commercialized under a 505(b)(2) application until we have recouped our expenses related to the development of that product. Once our expenses are recouped, we are required to split equally with SciDose the net proceeds from royalty income we receive from the sale of such product. For additional information regarding this arrangement, see Business License Agreements Development and License Agreement with SciDose (argatroban and bivalirudin).
During the quarter ended September 30, 2013, we recouped all of our expenses related to the development of argatroban and cumulative revenue exceeded the recouped expenses. As a result, we recognized approximately $0.5 million of royalty expense during that quarter. By comparison, in the quarter ended December 31, 2013, during which all revenues were subject to the revenue sharing arrangement with SciDose, we had approximately $1.2 million of royalty expense. Going forward, in the absence of a right to offset additional development expenses on argatroban, based on the terms of the agreement, we expect that our royalty expense related to argatroban will be equal to 50% of our revenue related to argatroban, which, for the December 31, 2013 quarter resulted in a gross profit margin of approximately 20%, as compared to gross profit margins ranging between approximately 35% and 45% for prior quarters. We would expect that our gross profit margin will remain at this lower level until we develop and commercialize other products which produce higher gross profit margins.
Liquidity and Capital Resources
Operating Activities, page 67
2. Regarding your accounts receivables at December 31, 2013 that exceeds your total revenue for the three months then ended, please disclose the amount of receivables due to product sales versus royalty income as well as the payment terms for each. As applicable, disclose the effects on liquidity of the timing of collection.
Response: In response to the Staffs Comments, the Company will reflect in a free-writing prospectus and in a pre-effective amendment to the Registration Statement on page 68 disclosure substantially consistent with the following:
The total amount of accounts receivable at December 31, 2013 was approximately $6.5 million, which included approximately $1.5 million of product sales and approximately $5.0 million of royalty income, all with payment terms of 45 days. For royalty income, the 45-day period starts at the end of the quarter upon receipt of the royalty statement detailing the amount of sales in the prior completed quarter; and for product sales the period starts upon delivery of product.
At December 31, 2013, our cumulative receivables related to royalty income include approximately $3.2 million in receivables from The Medicines Company, and our payables include a royalty payable of approximately $2.6 million to The Medicines Company, which payable represents 50% of the amounts received by us under our agreement with Sandoz for the marketing of argatroban. Our agreement with The Medicines Company does not contemplate the ability for the parties to net settle amounts receivable or payable. Notwithstanding this, the Company has periodically collected from The Medicines Company amounts that would be equal to the net amount of receivables due from The Medicines Company, but, because it is unclear whether such cash receipt is intended to be settlement of the net receivable or only a partial payment towards the gross receivable, and because the operative agreement does not contemplate netting, the Company has presented these receivables and payables in gross amounts on its financial statements. As a result, the cumulative receivable from The Medicines Company aggregates from period-to-period and has never been fully offset by actual cash payments received by us from The Medicines Company. At December 31, 2013, we recorded a receivable from Sandoz of $1.7 million and a payable to The Medicines Company of $0.9 million (based upon a 50% revenue split on Sandoz sales). At the same time, we recorded a receivable from The Medicines Company of approximately $1.5 million based on royalties owed to us by The Medicines Company. The net receivable from The Medicines Company for the quarter ended December 31, 2013 therefore would have been $0.7 million. The additional receivable of $1.7 million owing to us from The Medicines Company as of December 31, 2013 therefore represents the unpaid gross receivables from prior periods described above. We believe that our accounts receivable as of December 31, 2013, after taking into account netting of receivables and payables related to The Medicines Company, are
reasonably collectible, and given the payment terms, will be collected in the ordinary course in the second fiscal quarter, and thus would not have a material effect on our liquidity.
**********
Please advise us if we can provide any further information or assistance to facilitate your review. Please direct any further comments or questions regarding this response letter to me at (617) 937-2316. Thank you.
Sincerely, |
|
|
|
/s/ Marc A. Recht |
|
|
|
Marc A. Recht |
|
cc: |
Scott Tarriff, Eagle Pharmaceuticals, Inc. |
|
David Riggs, Eagle Pharmaceuticals, Inc. |
|
Miguel Vega, Cooley LLP |