SEC Company Response from Theriva Biologics, Inc. (TOVX) (CIK 0000894158) (TOVX) — Feb 8, 2011
Theriva Biologics, Inc. (TOVX) (CIK 0000894158)
Date: Feb. 8, 2011 · CIK: 0000894158 · Accession: 0001144204-11-006568
AI Filing Summary & Sentiment
File numbers found in text: 001-12584
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CORRESP
1
filename1.htm
Unassociated Document
February 8,
2011
VIA
EDGAR AND
OVERNIGHT
MAIL
United
States Securities
and
Exchange Commission
100 F
Street, NE
Mail Stop
4270
Washington,
D.C. 20549
Attention:
Jim
Rosenberg
Senior Assistant Chief
Accountant
Re:
Adeona
Pharmaceuticals, Inc.
Form
10-K for the Year Ended December 31, 2009
Form
10-Q for the Interim Period Ended June 30, 2010
File No.
001-12584
Dear Mr.
Rosenberg:
Thank you
for your January 31, 2011 letter regarding Adeona Pharmaceuticals, Inc.
(“Adeona”). We hereby submit a letter responding to the
comments. For your convenience, we have set forth below the staff’s
numbered comment followed by our response thereto.
Form 10-Q
for the Interim Period Ended June 30, 2010
Note 2.
Basis of Presentation
Revenue
Recognition" page 7
1.
We acknowledge your response to
comment 8. Please revise your draft disclosures to include how revenue
will be recognized to the extent contracts have continuing obligations or
additional deliverables. Additionally; revise your draft disclosure to
include your revenue recognition policy for royalty payments, including
how royalty revenue will be calculated and
recognized.
Response: Complied with. We
have revised our disclosures to include how revenue will be
recognized. We have also revised our disclosure to include our
revenue recognition policy for royalty payments.
United
States Securities and
Exchange
Commission
February
8, 2011
Page
2
The
Company records revenue when all of the following have occurred: (1) persuasive
evidence of an arrangement exists, (2) the service is completed without further
obligation, (3) the sales price to the customer is fixed or determinable, and
(4) collectability is reasonably assured. The Company recognizes
milestone payments or upfront payments that have no contingencies as revenue
when payment is received. The Company has two streams of revenue,
license revenue and laboratory revenue.
Licensing
agreements:
The
Company’s licensing agreements may contain multiple elements, such as
non-refundable up-front fees, payments related to the achievement of particular
milestones and royalties. Fees
associated with substantive at risk performance-based milestones are recognized
as revenue upon completion of the scientific or regulatory event specified in
the agreement. When the
Company has substantive continuing performance obligations under an arrangement,
revenue is recognized over the performance period of the obligations using a
time-based proportional performance approach. Under the time-based method,
revenue is recognized over the arrangement’s estimated performance period based
on the elapsed time compared to the total estimated performance period. Revenue
recognized at any point in time is limited to the amount of non-contingent
payments received or due. When the Company has no substantive continuing
performance obligations under an arrangement, it recognizes revenue as the
related fees become due.
Revenues from royalties on third-party sales of licensed
technologies are generally recognized in accordance with the contract terms when
the royalties can be reliably determined and collectibility is reasonably
assured. To date, the Company has not received any royalty
revenues.
On
May 6, 2010, the Company entered into a Sublicense Agreement (the “Meda
Agreement”) with Meda AB of Sweden (“Meda”) for the development and
commercialization of Effirma (flupirtine) for fibromyalgia. As
consideration for the sublicense, the Company received an up-front payment of
$2.5 million upon execution of the Meda Agreement. This payment was recorded as
license revenue in June 2010. Pursuant to the Company’s license agreement with
McLean Hospital, the Company paid 15% of the $2.5 million payment ($375,000) to
McLean Hospital. The payment to McLean Hospital was netted against
the revenues received from Meda AB for financial statement
purposes. The Company is also entitled to additional milestone
payments of $5 million upon filing of a New Drug Application with the United
States Food and Drug Administration for flupirtine for fibromyalgia and $10
million upon marketing approval. The Meda Agreement also provides that the
Company is entitled to receive net royalties of 7% of net sales of flupirtine
approved for the treatment of fibromyalgia covered by issued patent claims in
the United States and Japan. The Meda Agreement provides that Meda AB
will assume all future development costs for the commercialization of flupirtine
for fibromyalgia. Pursuant to the terms of the Company’s agreement with McLean
Hospital, the Company is obligated to pay them half of the royalties the Company
receives. Future milestone payments will be recorded as revenue when
payment is received as there are no future deliverables, and it is
non-refundable. We will make similar disclosure for any future license
agreements.
Adeona
Pharmaceuticals, Inc.
3930
Varsity Drive
Ann
Arbor, Michigan 48108
tel:
734.332.7800
fax:
734.332.7878
We
acknowledge that the adequacy and accuracy of the disclosure in our filings is
our responsibility. We acknowledge that the staff comments or changes to
disclosure do not foreclose the Commission from taking any action with respect
to the filings. We acknowledge that the company may not assert staff
comments as a defense in any proceedings initiated by the Commission or any
person under the federal securities laws of the United
States.
Sincerely,
/s/ James S. Kuo
James S. Kuo, MD, M.B.A
Chairman and
CEO