SEC Company Response from SOLIGENIX, INC. (SNGX) (CIK 0000812796) (SNGX) — Dec 18, 2006
SOLIGENIX, INC. (SNGX) (CIK 0000812796)
Date: Dec. 18, 2006 · CIK: 0000812796 · Accession: 0000812796-06-000073
AI Filing Summary & Sentiment
Referenced dates: December 5, 2006
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DOR SEC Comment Letter 2nd Response for Letter of 12-5-06
DOR
BioPharma, Inc.
1101
Brickell Avenue
701-S
Miami,
FL
33131
December
18, 2006
SENT
VIA EDGAR
Amy
C. Buckner
Staff
Accountant
Division
of Corporation Finance
United
States Securities and Exchange Commission
100
F
Street, NE
Washington,
D.C. 20549
RE:
Review of Filings and comments related to Form 10KSB for the Fiscal Year Ended
December 31, 2005 and Form 10QSB for the Fiscal Quarter Ended June 30, 2006.
Dear
Ms.
Buckner:
Thank
you
for the opportunity to work with you and discuss the disclosure requirements.
This letter is in response to your letter dated December 5, 2006. Below please
find our responses to your inquiries and comments.
Form
10-KSB for the Fiscal Year Ended December 31,
2005
Management’s
Discussion and Analysis or Plan of Operation
Material
Changes in Results of Operations
1.
We
acknowledge your response to comment 2. Please provide us with additional
information, in a disclosure-type format, that reconciles the total research
and
development expense presented in your proposed disclosure for each project
to
the total research and development expense on the face of your statement of
operations for the year ended December 31, 2005. More specifically, the
aggregate 2005 expense per proposed disclosure appears to be $5,766,478, which
does not reconcile to the face of your 2005 statement of operations. Please
either reconcile the individual project information to the aggregate 2005
expense or tell us why the amounts per your proposed disclosure do not reconcile
to the 2005 statement.
RESPONSE
for 1.:
We
hereby
supplement the information previously supplied to you for comment 2..
The
table
below details our costs for 2005 and 2006 by project.
2005
Projects-Research
& Development Expenses
orBec®
$
2,209,770
RiVax™
480,120
BT-VACC™
979,247
Oraprine™
8,100
LPMTM-Leuprolide
3,900
Research
& Development Expense
$
3,681,137
Projects-Reimbursed
under Grant
orBec®
$
124,958
RiVax™
1,942,076
BT-VACC™
-
Oraprine™
-
LPMTM-Leuprolide
-
Reimbursed
under Grant
$
2,067,034
TOTAL
$
5,748,171
In
addition, from previous response to 2.A, that read:
“Since
2000, we have incurred expenses of $13,925,498 in the development of
orBec®.
Research and development costs for orBec®
totaled $2,209,770 in 2005 and $1,940,052 in the second quarter of 2006. Since
June 30th
2006, we anticipate that the remaining R&D costs for orBec®
will
approximate $2 million. If orBec®
is
approved by the FDA in the first quarter of 2007, we expect
orBec®
to
begin generating revenues by the third quarter of 2007. If the FDA rejects
the
NDA or does not approve orBec®
in a
timely manner, our financial condition, liquidity, and ability to raise
additional equity financing could be impaired.”
Correction
to read:
Since
2000, we have incurred expenses of $13,925,498 in the development of
orBec®.
Research and development costs for orBec®
totaled
$2,209,770 in 2005 of which $124,958 are for costs reimbursed under the FDA
orphan products grant and $1,940,052 in the second quarter of 2006. Since June
30th
2006, we
anticipate that the remaining R&D costs for orBec®
will
approximate $2 million. If orBec®
is
approved by the FDA in the third quarter of 2007, we expect orBec®
to begin
generating revenues by the fourth quarter of 2007. If the FDA rejects the NDA
or
does not approve orBec®
in a
timely manner (or in accordance with anticipated and established timelines),
our
financial condition, liquidity, and ability to raise additional equity financing
could be impaired.
In
addition, from previous response to 2.B, that read:
“The
costs that we have incurred to develop RiVax™
since
2002 to date total $6,360,523. R&D costs for RiVax™
totaled $2,565,461 in 2005 and $2,130,516 in the second quarter of 2006”
Correction
to read:
The
costs
that we have incurred to develop RiVax™ since 2002 to date total $6,360,523.
R&D costs for RiVax™ totaled $2,422,196 in 2005 of which $1,942,076 are for
costs reimbursed under the NIH grant, and $2,130,516 in the second quarter
of
2006, of which $1,128,257 are for costs reimbursed under this grant.
Notes
to Consolidated Financial Statements
Note
2. Summary of Significant Accounting Policies
Intangible
Asset
2.
We
acknowledge your response to comment 4. Please provide us with further
detail regarding the “alternative future use” associated with both the
UTSW RiVax vaccine license ($425k) and the SRI Brookwood license fee
($600k), as contemplated under paragraph 11c. of SFAS No. 2. Specifically,
please tell us whether you could have used the RiVax vaccine and the
SRI/Brookwood platform technology, in their current condition at the
time
of purchase, in other identifiable research and development projects
that
you had identified to be commenced at a future date and whether you
could
reasonably believe that any such future projects would generate economic
benefit for your company. Finally, please clarify for us the financial
reporting period during which you capitalized each of these license
fees
and tell us what the unamortized balance was related to each as of
December 31, 2005.
RESPONSE
for 2.:
We
hereby
supplement the information previously supplied to you for comment 4. As
explained most of our intangible assets have alternative future uses; this
is
common in the pharmaceutical development industry. Of the intangible asset
balance, $1,025,000 is for up-front license costs. We purchased a license from
the University of Texas Southwestern (“UTSW”), for the license to the
RiVaxTM
vaccine
for $425,000. We also purchased a license from a “pharmaceutical company” namely
Southern Research Institute/Brookwood Pharmaceuticals, for a license of
microsphere technology for $600,000. We capitalize license costs because they
have alternative future use as referred to in paragraph
11 c. of SFAS No.2.
We
believe that both of these intangible assets purchased have alternative future
uses. With respect to UTSW, we believe that arising out of the development
of
the vaccine RiVaxTM,
our
vaccine against ricin toxin, could potentially be a therapeutic antibody product
to treat patients exposed to ricin toxin; this product would be purified
antibodies from the serum of vaccinated animals or humans. In addition, the
technology addresses specific methods to create vaccines from toxins that have
similar structure, so that it is possible that a series of related vaccines
can
be developed. The technology is also applicable to distinctly different forms
of
vaccines which can be utilized by different patient populations based on route
of delivery. Specifically, we envision future uses of the ricin vaccine for
oral
and nasal administration. Such uses also demand the introduction of
complementary technology. With respect to SRI/Brookwood, at the time we
purchased the license in 1998, we were aware that this technology was a platform
technology for oral and nasal delivery of vaccines. This technology was also
a
key element of the business model of Innovaccines Corporation, a joint venture
that we formed with Elan Corporation. In 2002, we and Elan dissolved
Innovaccines, but we purchased the Elan rights to the microsphere technology,
with a view toward developing its applications in biodefense and emerging
infectious disease vaccines. This included the application to anthrax, plague,
ricin, and other biowarfare toxins and pathogens. The value to us at the time
was certainly in the knowledge that it could be applied to the development
of
any and all subunit vaccines that could be administered orally, as well as
specific biodefense applications. Specifically, we engaged in product
development for an orally administered ricin vaccine based on the SRI/Brookwood
microspheres, but found that the technology did not have sufficient potency
for
commercial development. Consequently, due to its cost and reduced development
prospects we decided to terminate the SRI/Brookwood agreement and have
subsequently impaired the asset in the second quarter of 2006.
3.
We
acknowledge your response to comment 5. It remains unclear, based on
your
response, how you concluded that it is appropriate to capitalize costs
related to the protection/maintenance of your patent rights. Please
tell
us the basis for future accounting policy, referring to applicable
authoritative accounting literature. Please also quantify for us the
amount of such costs that you capitalized for the financial statement
periods presented in your 2005 Form 10-KSB and tell us where you
classified those cost on the related balance
sheets
RESPONSE
for 3.:
We
hereby
supplement the information previously supplied to you for comment 5. We
capitalize legal costs associated with the protection and maintenance of our
patents. For a development stage company with drug and vaccine products in
an
often lengthy basic and clinical research process, we believe that patent rights
form one of our most valuable assets. Patents and patent applications are a
key
currency of intellectual property, especially in the early stage of product
development, as their purchase and maintenance gives us access to key product
development rights from our academic and industrial partners. These rights
can
also be sold or sub-licensed as part of our strategy to partner our products
at
each stage of development. The legal costs incurred for these patents consist
of
work designed to protect, preserve, maintain and perhaps extend the lives of
the
patents. Therefore, our policy is to capitalize these costs and amortize them
over the remaining useful life of the patents. We
maintain that we capitalize this based on intangible assets and the alternative
future use as referred to in SFAS
No.142 and
in
paragraph 11 c. of SFAS No. 2 as
well
as in the response to 2.
During
2005, we capitalized $250,570 in patent related costs. This amount is
represented in the Cash Flow statement, in the section for investing activities
presented in the 2005 10-KSB financial statements. On the balance sheet this
amount is presented on the line intangible
assets, net
in the
amount of $1,803,020. We also explain this amount in note 5 of the 2005 10-KSB.
Attached is the excerpt from note 5.
5.
Intangible Assets
The
following is a summary of intangible assets which consists of licenses and
patents:
Weighted
Average Amortization period
(years)
Cost
Accumulated
Amortization
Net
Book Value
December
31, 2005
10.2
$
2,605,472
$
802,452
$
1,803,020
December
31, 2004
10.6
$
2,611,195
$
728,741
$
1,882,454
Amortization
expense was $168,841 and $302,449 for 2005 and 2004, respectively.
Revenue
Recognition
4.
We
acknowledge your response to comment 6. Please confirm that you will
include the expanded disclosure provided in your September 8, 2006
response letter in your next periodic report to be filed with the
Commission, presumably your December 31, 2006 Form 10-KSB.
RESPONSE
for 4.:
We
will
include the following disclosure in future filings:
All
of
our revenues are from government grants which are based upon subcontractor
costs
and internal costs covered by the grant, plus a facilities and administrative
rate that provides funding for overhead expenses. Revenues are recognized when
expenses have been incurred by subcontractors or when we incur internal expenses
that are related to the grant.
Note
7. Shareholders’ Equity
Common
Stock
Stock
Compensation to
Non-Employees
5.
We
acknowledge your response to comment 8. Pursuant to Question 18 of FIN 44, it
does not appear that a “grant date” existed for the 2004 employee/director
options in question until your board/shareholders approved your 2005 Equity
Incentive Plan. As a result, it remains unclear why you believe variable
accounting was appropriate for these stock options in December 2004. Giving
consideration to Question 18 of FIN 44, please clarify your accounting position
for us. Additionally, please provide us with a materiality analysis under
provisions of SAB No. 99 with respect to the $285,000 that you recorded as
expense in fiscal 2004 and subsequently reversed to income in fiscal
2005.
RESPONSE
for 5.:
We
believe that the answer provided in our previous response is adequate
notwithstanding question 18 of FIN 44, that concludes that if a grant is not
approved a measurement date does not exist and that in December of 2004, our
authorized number of options under the then current 1995 stock option plan
was
insufficient to grant the options described above. The options were 1,764,339
in
excess of the authorized number. Therefore, determination of a measurement
date
was not possible until the new plan was approved by the shareholders. According
to FIN28, Footnote 1, “Plans for which the number of shares of stock that may be
acquired by or awarded to an employee or the price or both are not specified
or
determinable until after the date of grant