SEC Comment Letter for ELITE PHARMACEUTICALS (ELTP) — Nov 23, 2015
ELITE PHARMACEUTICALS INC /NV/ (ELTP) (CIK 0001053369)
Date: Nov. 23, 2015 · CIK: 0001053369 · Accession: 0000000000-15-054986
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Mail Stop 4720
November 20, 2015
Via E -mail
Mr. Carter J. Ward
Chief Financial Officer
Elite Pharmaceuticals, Inc.
165 Ludlow Avenue
Northvale, NJ 07647
Re: Elite Pharmaceuticals, Inc.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Filed June 15, 2015
Form 10 -Q for the Quarter ly Period Ended June 30, 2015
Filed August 10, 2015
Form 10 -Q/A for the Quarterly Period Ended September 30, 2015
Filed November 10, 2015
File No. 001 -15697
Dear Mr. Ward:
We have reviewed your October 26, 2015 res ponse to our comment letter and have the
following comments. In some of our comments, we may ask you to provide us with information
so we may better understand your disclosure.
Please respond to this letter within 10 business days by providing the requested
information or advis e us as soon as possible when you will respond . If you do not believe a
comment applies to your facts and circumstances, please tell us why in your respo nse.
After reviewing your response to these comments, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
September 25, 2015 letter.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant Accounting Policies
Revenue Recognition, page F -11
1. Refer to our prior comment 2. Please revise your proposed disclosures to discuss your
allocation of arrangement consideration to the separate units of accounting. In this
regard, revise your policy that indicates that revenue is recognized when “fair val ue can
be determined” to indicate that arrangement consideration is allocated at the inception of
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
November 20, 2015
Page 2
the arrangement based on relative selling prices. See ASC 605 -25-30-2. Include a
discussion of the significant factors, inputs, assumptions and methods used to determine
selling price for the significant deliverables under multiple -element revenue
arrangements, including whether the determination was based on vendor -specific
objective evidence, third party evidence or best estimate of selling price. Refer to ASC
605-25-50-2(e).
Note 4 – Intangible Assets, page F -14
2. Refer to your response to our prior comment 3. It appears that your direct experience
with the products related to your ANDA’s is limited, with four products launched during
2015. Please provid e your analysis of known or foreseeable obsolescence, demand,
competition or other economic factors that would support your assertion that the ANDA’s
have indefinite lives. Include in your response the date of FDA approval for the branded
product the ANDA is based on, the date the product became generic, the treatment
indication, and other factors supporting your conclusions. Also, please confirm whether
any capitalized patent costs are related to the ANDA assets.
Note 20 – Concentrations, page F -32
3. Refer to your response to our prior comment 7. It appears that your revenue related to
NDA’s is due to the Epic Collaborative Agreement and that you do not currently have
any NDA product sales. Please provide us proposed disclosure to be included in futu re
periodic reports of your revenue by product or group of products as required by ASC
280-10-50-40, or explain to us why it is impractical to do so. Additionally, please revise
your proposed disclosure to clarify whether you manage your business as one s egment or
if the disaggregation of revenues between NDA and ANDA products represents two
reportable segments.
Note 22 – Related Party Transaction – Manufacturing and License Agreement with Epic Pharma
LLC, page F -34
4. Refer to your response to our prior comment 8. Notwithstanding your receipt of
confidential treatment for specific rates used to calculate your license fees under your
license, manufacturing and development agreements, investors are entitled to an
understanding of the material terms of each of your material agreements. Please revise
your disclosure to provide a range of potential rates for the license fees the parties may be
obligated to pay under these agreements. Please ensure that your disclosed range is
within a ten per -cent range (e.g . “10 -20%”, “single -digits”, “twenties”, as applicable).
Please note that we are requesting disclosure of the range of potential license fees not
disclosure of specific rates.
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
November 20, 2015
Page 3
Form 10-Q for the Quarterly Period Ended June 30, 2015
Notes to Condense d Consolidated Financial Statements
Note 12 – Collaborative Agreement with Epic Pharma LLC , page F-12
5. Refer to your response to our prior comment 9. Please address the following additional
comments:
Tell us why you do not appear to identify the exclusive license to market and sell
ELI-200 in the U.S. as a deliverable under your agreement with Epic.
Tell us whether this license was conveyed to Epic upon execution of the agreement
on June 4, 2015 and, if not, tell us when the license was or will be conveyed .
Although your prior research and development activities associated with ELI -200
reasonably contributed to the value inherent in the rights to ELI -200 and your ability
to license these rights to Epic, explain how the past research and development
activities are a deliverable and have standalone value to Epic. In this regard, as Epic
only has license rights to market and sell ELI -200 it appears that the license rights are
dependent upon the success of your future development services.
Tell us wheth er and how Epic can exploit its license rights prior to regulatory
approval of ELI -200. Tell us whether Epic can sell its license to someone else or
whether it can sublicense the rights.
Provide us proposed revised disclosure to be included in future peri odic reports that
describes your accounting for the agreement in accordance with ASC 605 -25.
Disclose the significant deliverables within the arrangement, the timing of delivery,
the performance provisions, and whether and how separate units of accounting were
identified as stipulated in ASC 605 -25-50-2. In that regard, your current disclosure
appears to follow disclosure requirements of ASC 605 -28.
Form 10-Q/A for the Quarterly Period Ended September 30, 2015
Notes to Condensed Consolidated Financial S tatements
Note 12 – Reclassification of Convertible Preferred Shares, page F -13
6. We acknowledge your response to our prior comments 4 and 5 and note the change of
accounting highlighted in this footnote. Your change in accounting for your convertible
preferred shares represent s the correction of an error rather than a reclassification as a
reclassification is limited to changing from one generally accepted presentation to
another. As a result, please address the following:
Please file an Item 4.02 Form 8-K highlighting the restatement of your March 31,
2015 Form 10 -K and Forms 10 -Q for the quarterly periods ended September 30,
2014, December 31, 2014 and June 30, 2015 or explain to us why such filing s are
not required.
Please file amendments to your Marc h 31, 2015 Form 10 -K and Forms 10 -Q for
the quarterly periods ended September 30, 2014, December 31, 2014 and June 30,
2015 reflecting the restatement of your financial statements.
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
November 20, 2015
Page 4
For each of the amendments identified in the previous bullet point, please ensure
you label each column in your basic financial statements that reflect restated
amounts as being “restated.”
Please file an amendment to your September 30, 2015 Form 10 -Q to include
disclosure of the impact to the June 30, 2015 financial statements a s required by
ASC 250 -10-50-11.
Please have your auditors update their opinion on the audit of your March 31,
2015 and 2014 financial statements included in your amended Form 10 -K for
March 31, 2015.
In each of the amendments identified above, please ensur e you address the
following:
o Revise your disclosure to indicate that you carry your convertible preferred
stock at the maximum redemption amount not its fair value and that the
associated change in carrying value is not a change in fair value. Also,
indic ate that increases in redemption value are charged to retained earnings or
to additional paid -in capital in the absence of retained earnings. See ASC
480-10-S99-3A.14.
o Disclose the terms, preferences and conversion features of your convertible
preferred s tock as originally requested in our prior comment 4.
o Revise your report on internal controls over financial reporting to address the
cause of the restatement for the periods presented .
You may contact Rolf Sundwall, Staff Accountant , at (202) 551 -3105 or Mark
Brunhofer, Senior Staff Accountant, at (202) 551 -3638 if you have any questions regarding the
comment s. In this regard, do not hesitate to contact me at (202) 551 -3679 .
Sincerely,
/s/ Jim B. Rosenberg
Jim B. Rosenberg
Senior Assistant Chief Accountant
Office of Healthcare and Insurance