SEC Comment Letter for ELITE PHARMACEUTICALS (ELTP) — Sep 25, 2015
ELITE PHARMACEUTICALS INC /NV/ (ELTP) (CIK 0001053369)
Date: Sept. 25, 2015 · CIK: 0001053369 · Accession: 0000000000-15-047279
AI Filing Summary & Sentiment
Show Raw Text
Mail Stop 4720
September 25, 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, 2014
File No. 001 -15697
Dear Mr. Ward:
We have limited our review to only your financial statements and related disclosures and
have the following comments . In some of our comment s, 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 by advising us when you will provide the requested re sponse. If you do not
believe a c omment appl ies to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP th at keys your
response s to our comment s.
After reviewing the information you provide, we may have additional comments and/or
request that you amend your filing.
Form 10 -K for the Fiscal Year Ended March 31, 2015
Research and Development, page 12
1. Notwithstanding your policy not to disclose research and development activities for
competitive reasons, w e believe disclosing information about each of your key
development programs is important to an understanding of your operations and prospects.
In thi s regard, we realize that you disclose some information about your development
projects on your website. Please provide us proposed disclosure to be included in
Business and MD&A in future periodic reports that provides the following information
for each of your key research and development projects:
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
September 25, 2015
Page 2
The current status of the project;
The costs incurred during each period presented and to date on the project;
The anticipated completion dates;
The risks and uncertainties associated with completing development on schedule, and
the consequences to operations, financial position and liquidity if the project is not
completed timely; and finally
The period in which material net cash inflows from significant projects are expected
to commence.
If you do n ot track your research and development costs by project, please disclose that
fact and explain why you do not maintain and evaluate research and development costs
by project. Provide other quantitative or qualitative disclosure that indicates the amount
of your resources being used on the project. Regarding anticipated completion dates,
disclose the amount or range of estimated costs and timing to complete the phase in
process and each future phase. To the extent that information is not estimable, disclo se
those facts and circumstances indicating the uncertainties that preclude you from making
a reasonable estimate.
Notes to Consolidated Financial Statements
Note 1 – Summary of Significant Accounting Policies
Revenue Recognition, page F -11
2. Please prov ide us proposed revised disclosure to be included in future periodic reports
that clarifies how you apply the guidance in ASC 605 -25, Multiple -Element
Arrangements, in recognizing revenue under your various licensing, manufacturing and
development agreemen ts.
Note 4 – Intangible Assets, page F -14
3. You disclose that you begin amortization of your ANDA and patent intangibles upon
receipt of approval of site transfers and the patent, respectively. Please tell us why you
have not amortized any of your intangi ble assets when, at a minimum, it appears that you
have 10 issued patents as disclosed on page 13 and that two of the products that appear to
be included in your ANDA intangible (Phentermine HCl 37.5mg tablets and
Phendimetrazine Tartrate 35mg tables) were launched in April 2011 and November 2012,
respectively, based on information in the table on page 5. In your response, please
provide the following information for your ANDA intangible assets:
The name of each asset;
The amount capitalized for each asset;
The date of acquisition;
The date of receipt of approval of site transfer (if applicable);
The date of your product launch (if applicable); and
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
September 25, 2015
Page 3
The effective date of any manufacturing agreements with other parties to produce the
product (including t hose agreements to produce product only until you receive
regulatory approval on site transfer).
Note 13 – Derivative Liabilities – Preferred Shares, page F -22
4. Please provide us proposed disclosure to be included in future periodic reports describing
the terms, preferences and conversion features of your Series I Preferred Stock. Refer to
ASC 505 -10-50, primarily 50 -3 and 50 -4.
5. Please provide your analysis supporting derivative liability treatment for each of your
series of preferred stock, referencing for us the authoritative literature you relied upon to
support your accounting. In your response, please also address the following specific
questions:
Tell us why you do not bifurcate the embedded conversion features from your host
preferred stock. If you elected to account for the entire hybrid instruments at fair
value under ASC 815 -15-25-4 through 25 -6, tell us your consideration of the
prohibition to reflect equity instruments under this fair value election stipulated in
ASC 815 -15-25-6 and ASC 825 -10-50-8i.
Tell us whether, and explain why, each series of preferred stock as the host
instrument is akin to debt or equity in assessing the clearly -and-closely related
criterion of ASC815 -15-25-1a. See ASC 815 -15-25-16 through 25 -51A.
Note 20 – Concen trations, page F -32
6. Please provide us proposed revised disclosure to be included in future periodic reports
that quantifies the amount of revenue earned by each of your major customers; those
defined as comprising more than 10% of your total revenues. Se e ASC 280 -10-50-42.
7. Please provide us proposed disclosure to be included in future periodic reports of your
revenue by product or group of products as required by ASC 280 -10-50-40.
Note 22 – Related Party Transaction —Manufacturing and License Agreement w ith Epic Pharma
LLC, page F -34
8. Please provide us proposed revised disclosure to be included in future periodic reports
that describes each substantive milestone and the related contingent consideration as well
as the range of royalty and gross profit rates used to calculate your license fees under the
agreement. Please provide this information for each licensing, manufacturing and
development agreement you describe beginning on page 9. If the agreements are not
significant, please disclose the amount s in the aggregate. Refer to ASC 605 -28-50-2b.
Mr. Carter J. Ward
Elite Pharmaceuticals, Inc.
September 25, 2015
Page 4
Form 10 -Q for the Quarterly Period Ended June 30, 2015
Notes to Condensed Consolidated Financial Statements
Note 12 – Collaborative Agreement with Epic Pharma LLC, page F -12
9. You disclose that all mileston es under the Epic Collaborative Agreement are substantive
and that you recognized $5 million of these in the first quarter of 2015. Please tell us the
triggering event(s) that resulted in the recognition of this $5 million and why immediate
recognition wa s appropriate. In this regard , it appears from disclosure in Note 28 on page
F-39 of your 2015 Form 10 -K that your first milestone payment was due and received
upon signing of the agreement, which does not appear to meet the significant uncertainty
criter ion at contract inception under the definition of milestones in ASC 605 -28-20.
Reference for us the specific authoritative literature you relied upon to support your
accounting.
We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing s to be certain that the filing s include all information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require. Since the company and its management are
in possession of all facts relating to a compa ny’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.
In responding to our comment s, please provide a written statement from the company
acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing s;
staff comment s or changes to disclosu re in response to staff comment s do not foreclose
the Commission from taking any action with respect to the filing s; and
the compa ny may not assert the staff comment s as a defense in any proceeding initiated
by the Commission or any person under the federal securities laws of the United States.
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