SEC Company Response from VIRAL GENETICS — Nov 14, 2005
VIRAL GENETICS INC /DE/ (CIK 0001091326)
Date: Nov. 14, 2005 · CIK: 0001091326 · Accession: 0001020488-05-000188
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File numbers found in text: 000-26875
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VIRAL GENETICS, INC.
1321 Mountain View
Circle
Azusa, CA 91702
Telephone: (626)
224-5310
Fax: (626) 224-5324
November 14, 2005
Securities & Exchange
Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, DC 20549
Attention:
Jim Rosenberg
Tabatha Akins, Staff Accountant
Mail
Stop 6010
Re:
Viral Genetics, Inc. – File No. 000-26875
Form
10-KSB for the fiscal year ended December 31, 2004
Dear Mr.
Rosenberg and Ms. Akins:
The following
are our responses to the September 16, 2005 comment letter.
Item
6. Management's Discussion and Analysis or Plan of Operations,
page 18
Plan of
Operation, page 18
Background,
page 18
1.
Please provide to us, in disclosure-type format, management’s plans to
overcome the financial difficulties. In your discussion, please address the
ability or inability to generate sufficient cash to support your operations
during the twelve-month period following the date of the financial statements.
Refer to Section 607.02 of the Financial Reporting Codification.
We
would propose to add the following discussion to Item 6:
Viral
Genetics is a development stage company with no revenues. We are dependant on capital
obtained from outside sources to fund our operations.
Pharmaceutical
products have an extended development and approval process, which we have pursued during
the past year with our product VGV-1 and we intend to continue to pursue over the next 12
months and in the foreseeable future beyond that period. We have not filed an
Investigational New Drug application in the United States. We are in the process of
preparing an application for filing, but the United States regulatory
approval process
usually takes years, so we do not expect there will be any domestic sales of our product
for at least several years. The Company is now completing a clinical trial in South
Africa, the results of which are expected in the first quarter of 2006. If the trial
produces positive results that lead to market approval in South Africa, the Company could
be in a position to begin generating revenue from product sales overseas within the next
12 to 24 months. At this point it is impossible to predict whether any such sales could be
significant to the Company. If the trial results are promising but a second trial is
required, we will be required to invest in a second clinical trial; however in this case,
based on our current arrangement with our distribution management agent, only half of
these expenses would be the Company’s obligation. If the trial is unsuccessful
altogether or is inconclusive, we will be required to reconsider the next phase of our
business plan which will likely include additional earlier-stage research.
Since
the Company does not have revenue from product sales, it is dependent on debt and equity
financing and on funding derived from distribution arrangements. General and
administrative expenses over the next 12 months are estimated at approximately $1.2
million. If the Company is able to obtain market approval for its product in South Africa,
the Company estimates it will require approximately $10 million of additional working
capital to ramp up production of VGV-1. If additional clinical trials overseas are
required, the Company estimates that approximately $1 million would be required to pursue
that effort.
There
is no assurance that the Company will be able to obtain funding for its proposed
operations over the next 12 months. Whether it will be able to do so depends on a number
of factors beyond its control, including, but not limited to, the success or failure of
on-going clinical trials, the requirements and progress of regulatory approval processes,
and the availability of capital from third party sources. These uncertainties raise
substantial doubt about the ability of the Company to continue as a going concern.
Financial
Statements – December 31, 2004
Report
of Independent Registered Public Accounting Firm, page 1
2.
We note that the opinion of your auditors limits its compliance with PCAOB
standards to only the “auditing” standards. This appears to be a more
limited standard than is required by paragraph 3 of PCAOB Auditing Standard No.
1. Please have your auditors confirm to us that they complied with all of the
PCAOB “standards”.
The
auditors have supplied us with a new report on the December 31, 2004 financial statements
using the prescribed language of the PCAOB including the reference to PCAOB standards, and
not PCAOB audit standards. We will file that report with any other amendments arising out
of the comment letter in an amended Form 10-KSB for 2004.
2
Note 4
– Patents, page 14
3.
We note that the company will begin amortizing patents “once the Company
begins production”. Please tell us how this complies with GAAP. We believe
that paragraphs 11 and 12 of SFAS 142 require that the patents be amortized over
their useful life using a method that reflects the pattern in which economic
benefits will be consumed. However, if a pattern of economic benefits cannot be
reliable determined, which appears to be your case, the straight-line
amortization method should be used commencing upon acquisition of the intangible
asset. Further please provide us in disclosure-type format information about
goodwill and patents as required by paragraphs 44 and 45 of SFAS 142.
The
Company began amortizing its patents in the quarter ending June 30, 2005, under the
understanding that the value originally ascribed to Patents and Goodwill was not to be
treated as having an indefinite life, subject to impairment. The Company has patents from
foreign filings which now have definite lives. The Company has elected to amortize this
value over twenty years, although it would be subject to impairment if the underlying
medical products prove not to be efficacious.
Originally
the company had regarded the value ascribed to Patent and Goodwill as patents which had
not been placed in service awaiting the approval of regulatory agencies. With the adoption
of SFAS No. 142, the Company regarded the value ascribed to Patents and Goodwill as
Goodwill with an indefinite life subject to impairment. Actually the amount is part of
each of these accounts. As of the June 30, 2005 Review, the Company began to treat the
whole amount as patents subject to amortization. The Company has expensed all other patent
expenses as operating costs. This amount under Goodwill and Patents represent the value
ascribed to the original purchase of the technology from third parties and others in the
formation of the predecessor company back in 1995. The amount attributable to the Patents
account is not considered material.
Notwithstanding
this, we have begun the amortization in 2005 based upon the interpretation that a definite
life has now been determined. If the Staff believes that the amortization should have
started in 2002 with the adoption of SFAS No. 142, we would not be adverse to making such
disclosure and amending the filings accordingly.
Note 5
– Commitments and Contingencies, page 14
Distribution
Agreements, page 15
4.
It appears that the distribution right discussed here are what resulted in the
gain categorized a “Sale of distribution rights” in your statement of
operations on page 3. If so, please tell us how the amount disclosed in the last
paragraph relates to the amount disclosed in the statement of operations. If
they are unrelated, then please tell us where this sale is addressed within the
notes to your financial statements.
The
discussion of Distribution rights is included on Pages 15 and 16 of the financial
statements. Assuming your comment is addressed to the last paragraph and not the
3
paragraph
on page 15, the breakdown of the distribution rights proceeds was $100,000 and $109,966
from South African operations with now-terminated partners, and $650,000 in cash and
$200,000 in debt forgiveness from the South African distribution rights from our current
partner as discussed in the last paragraph. Every amount or consideration actually
received is included in the $1,059,966. The $400,000, which is also mentioned in our
filing, was never received since it was limited to the unexercised and expired options
finally granted in the negotiations with the terminated partner.
Note 8
– Notes Payable and Related Party Transactions, page 18
5.
We note that your revised the terms related to these notes in June 2003. Please
explain to us, in disclosure type format, the accounting consequences of those
revisions. Include the specific terms of the notes that changed other than just
the due date. Also provide us your analysis under EITF 98-5 and 00-27 supporting
whether or not you recorded a beneficial conversion feature related to the
revised notes given that the conversion ratio was less than the apparent then
trading price.
The
renewal of the loans was negotiated during the first half of 2003 when our common stock
was trading at or below $0.30 per share, although the stock price had increased in May and
June 2003. Further, during this period, the Company raised capital through private
placements of its common stock with arms-length investors at a price of $0.2135.
Consequently, the $0.30 conversion price was deemed to be at least fair market value and
without any further discounts, and resulting calculations in accordance with EITF 98-5 and
00-27 resulted in no beneficial conversion price. The Company is a small company with
limited staff, and sometimes it takes weeks or months to complete negotiations. When the
values were determined in March and April of 2003 the conversion price was deemed
reasonable. Later in the year, the stock trading price did drop back to the thirty cents
level.
Note 11
– Merger and Acquisition, page 22
Acquisitions,
page 22
6.
Please tell us, in disclosure-type format, what you acquired in connection with
this merger. In your discussion, please include all of the disclosure
requirements of paragraph 51 of SFAS 141 including a purchase price allocation.
As
stated in Note 11 of the financial statements, Therapeutic Genetic, Inc. was holding
$7,504,274 in notes payable and accrued interest at the time of the acquisition. The
transaction resulted in an increase in the equity accounts and resulted in 24,308,580
additional shares being issued. An allocation to the shares and underlying warrants
resulted in the Company recognizing on a Consolidated basis additions to warrants of
$3,226,838 and additions to common stock and additional paid-in capital of $4,277,436. The
only remaining assets held by Therapeutic were the notes owed by Viral and the notes were
effectively retired by the exchange of stock. There were no other assets to allocated
value in this transaction.
4
The Company hereby
acknowledges that:
• the Company is responsible for the adequacy and accuracy of the disclosure in the filings;
• staff comments or changes to
disclosure in response to staff comments do not foreclose the Commission from talking any
action with respect to the filing; and
• the Company may not assert staff comments as
a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
If you have any questions, or wish to
discuss any of these matters, please contact Mr. Haig Keledjian at 626-334-5310. Thank you
for your consideration in allowing us the additional time to respond.
Very truly yours,
/s/Haig
Keledjian
President and Chief
Executive Officer