HARROW, INC. - Quarter Report: 2008 March (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x |
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE OF
1934
|
For
the
quarterly period ended March
31, 2008
o |
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
For
the
transition period from to
Commission
file number: 000-52998
Transdel
Pharmaceuticals, Inc.
(Exact
Name of Registrant in Its Charter)
Delaware
|
45-0567010
|
|
(State
or Other Jurisdiction of Incorporation
or
Organization)
|
(I.R.S.
Employer Identification No.)
|
|
4225
Executive Square, Suite 460
La
Jolla, CA
|
92037
|
|
(Address
of Principal Executive Offices)
|
(Zip
Code)
|
|
(858)
457-5300
|
(Registrant’s
Telephone Number, Including Area Code)
|
(Former
Name, Former Address and Former Fiscal Year, if Changed Since Last
Report)
|
Indicate
by check mark whether the registrant: (1) has filed all reports required to
be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements
for
the past 90 days. Yes x No o
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). YES ¨ NO
x
As
of May
14, 2008, 15,545,184 shares of issuer’s common stock, with $0.001 par value per
share were outstanding.
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
See
the definitions of "large accelerated filer", "accelerated filer" and "smaller
reporting company" in Rule 12b-2 of the Exchange Act (Check
One):
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Smaller
reporting company x
|
(Do not check if a smaller reporting company) |
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
Table
of Contents
|
Page
|
|||
Part
I
|
FINANCIAL
INFORMATION
|
2 | ||
Item
1.
|
Financial
Statements
|
2 | ||
|
Condensed
Consolidated Balance Sheets – March 31, 2008 (Unaudited) and December
31, 2007
|
2
|
||
Unaudited
Condensed Consolidated Statements of Operations for the three-month
periods ended March 31, 2008 and 2007
|
3
|
|||
Unaudited
Condensed Consolidated Statements of Cash Flows for the three-month
periods ended March 31, 2008 and 2007
|
4
|
|||
Notes
to the Unaudited Condensed Consolidated Financial Statements
|
5
|
|||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
14
|
||
Item
4T.
|
Controls
and Procedures
|
16
|
||
Part
II
|
OTHER
INFORMATION
|
17 | ||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
17
|
||
Item
6.
|
Exhibits
|
17
|
i
PART
I
FINANCIAL
INFORMATION
Item
1. Financial
Statements.
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
CONDENSED
CONSOLIDATED BALANCE SHEETS
March
31,
|
December
31,
|
||||||
2008
|
2007
|
||||||
(Unaudited)
|
|||||||
ASSETS
|
|||||||
Current
assets:
|
|||||||
Cash
|
$
|
3,408,244
|
$
|
3,706,369
|
|||
Prepaid
consulting
fees
|
298,621
|
488,748
|
|||||
Prepaid
expenses and other
current assets
|
37,378
|
45,604
|
|||||
Total
assets
|
$
|
3,744,243
|
$
|
4,240,721
|
|||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
|||||||
Current
liabilities:
|
|||||||
Accounts
payable
|
$
|
427,588
|
$
|
696,340
|
|||
Accrued
expenses and payroll
liabilities
|
43,574
|
53,901
|
|||||
Total
liabilities
|
$
|
471,162
|
$
|
750,241
|
|||
Stockholders’
equity:
|
|||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized, none
outstanding
|
-
|
-
|
|||||
Common
stock, $0.001 par value; 50,000,000 shares authorized,
13,727,004 shares outstanding
|
13,727
|
13,727
|
|||||
Additional
paid-in capital
|
10,609,620
|
10,554,298
|
|||||
Deficit
accumulated during the development stage
|
(7,350,266
|
)
|
(7,077,545
|
)
|
|||
Total
stockholders’ equity
|
3,273,081
|
3,490,480
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
3,744,243
|
$
|
4,240,721
|
2
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended
March 31, |
For the
Period From July 24, 1998 (Inception) Through March |
|||||||||
2008
|
2007
|
31, 2008
|
||||||||
Operating
expenses:
|
||||||||||
Selling,
general and administrative
|
$
|
447,855
|
$
|
100,221
|
$
|
3,531,436
|
||||
Research
and development
|
219,100
|
37,500
|
2,776,844
|
|||||||
Operating
loss
|
666,955
|
137,721
|
6,308,280
|
|||||||
Other
income (expense):
|
||||||||||
Interest
expense
|
-
|
(2,207
|
)
|
(1,575,755
|
)
|
|||||
Interest
income
|
19,234
|
-
|
68,855
|
|||||||
Gain
on forgiveness of liabilities
|
-
|
-
|
89,914
|
|||||||
Gain
on settlement
|
375,000
|
-
|
375,000
|
|||||||
Total
other income (expense), net
|
394,234
|
(2,207
|
)
|
(1,041,986
|
)
|
|||||
Net
loss
|
$
|
(272,721
|
)
|
$
|
(139,928
|
)
|
$
|
(7,350,266
|
)
|
|
Basic
and diluted loss per common share
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
||||
Weighted
average common shares outstanding
|
13,727,004
|
5,034,404
|
3
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
UNAUDITED
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For The Period
|
||||||||||
From July 24,
|
||||||||||
1998
(Inception) |
||||||||||
Three Months Ended
|
Through
|
|||||||||
March 31,
|
March 31,
|
|||||||||
2008
|
2007
|
2008
|
||||||||
Cash
from operating activities:
|
||||||||||
Net
loss
|
$
|
(272,721
|
)
|
$
|
(139,928
|
)
|
$
|
(7,350,266
|
)
|
|
Adjustments
to reconcile net loss to net cash used in
operating activities:
|
||||||||||
Estimated
fair value of contributed services
|
-
|
100,000
|
2,475,000
|
|||||||
Gain
on forgiveness of liabilities
|
-
|
-
|
(89,914
|
)
|
||||||
Amortization
of prepaid consulting fees
|
137,627
|
-
|
338,879
|
|||||||
Non-cash
interest on notes payable
|
-
|
2,207
|
1,575,755
|
|||||||
Stock-based
compensation
|
144,051
|
-
|
328,573
|
|||||||
Changes
in operating assets and liabilities:
|
||||||||||
Prepaid
consulting costs
|
-
|
-
|
(140,000
|
)
|
||||||
Prepaid
expenses and other current assets
|
8,226
|
1,599
|
(37,378
|
)
|
||||||
Accounts
payable
|
(268,752
|
)
|
18,275
|
517,503
|
||||||
Accrued
expenses and payroll liabilities
|
(10,327
|
)
|
-
|
43,573
|
||||||
Net
cash used in operating activities
|
(261,896
|
)
|
(17,847
|
)
|
(2,338,275
|
)
|
||||
Cash
flows from financing activities:
|
||||||||||
Proceeds
from notes payable to stockholders
|
-
|
-
|
226,300
|
|||||||
Proceeds
from notes payable
|
-
|
-
|
1,500,000
|
|||||||
Capital
contributions
|
-
|
907
|
168,707
|
|||||||
Proceeds
from purchase of common stock and exercise of warrants and stock
options
|
-
|
25,500
|
49,950
|
|||||||
Net
(costs) proceeds from Private Placement
|
(36,229
|
)
|
-
|
3,801,562
|
||||||
Net
cash (used in) provided by financing activities
|
(36,229
|
)
|
26,407
|
5,746,519
|
||||||
Net
change in cash
|
(298,125
|
)
|
8,560
|
3,408,244
|
||||||
Cash,
beginning of period
|
3,706,369
|
542
|
-
|
|||||||
Cash,
end of period
|
$
|
3,408,244
|
$
|
9,102
|
$
|
3,408,244
|
||||
Supplemental
disclosure of cash flow information:
|
||||||||||
(Revaluation)
issuance of common stock and warrants to consulting firms for prepaid
consulting fees
|
$
|
(52,500
|
)
|
$
|
-
|
$
|
497,500
|
|||
Conversion
of notes payable and accrued interest into common stock
|
$
|
-
|
$
|
-
|
$
|
1,530,177
|
||||
Forgiveness
of notes payable and accrued interest to shareholders
|
$
|
-
|
$
|
-
|
$
|
241,701
|
||||
Conversion
of notes payable to shareholders
|
$
|
-
|
$
|
-
|
$
|
196,300
|
4
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
1. Business Description
Transdel
Pharmaceuticals, Inc. (“Transdel” or the “Company”) is a specialty
pharmaceutical company focused on the development and commercialization of
non-invasive topically delivered medications. The Company's lead topical drug,
Ketotransdel TM,
utilizes the Company's proprietary Transdel TM
cream
formulation to facilitate the passage of ketoprofen, a non-steroidal
anti-inflammatory drug (“NSAID”), through the skin barrier to reach targeted
underlying tissue where the drug exerts its prolonged localized
anti-inflammatory and analgesic effect. The Company is also investigating other
drug candidates and treatments for transdermal delivery using the
TransdelTM
platform
technology for products in pain management and other therapeutic
areas.
Note
2. Basis of Presentation
The
Company has prepared the accompanying unaudited condensed consolidated financial
statements in accordance with United States generally accepted accounting
principles (“GAAP”) for interim financial information and with the rules and
regulations of the Securities and Exchange Commission (the “SEC”) related to a
Quarterly Report on Form 10-Q and Article 8 of Regulation S-X. Accordingly,
they
do not include all of the information and disclosures required by GAAP
for
annual financial statements. The
consolidated financial statements include the accounts of Transdel and its
wholly owned subsidiary, Transdel Pharmaceuticals Holdings, Inc. (formerly
known
as Trans-Pharma Corporation). All significant intercompany balances and
transactions have been eliminated in consolidation. In the opinion of the
Company’s management, the accompanying condensed consolidated financial
statements contain all the adjustments necessary (consisting only of normal
recurring accruals) to make the financial position of the Company as of March
31, 2008, the results of operations for three months ended March 31, 2008 and
2007, and cash flows for the three months ended March 31, 2008 and 2007, fairly
stated. The condensed consolidated financial statements should be read in
conjunction with the audited financial statements for the year ended
December 31, 2007 contained in Form 10-KSB filed on March 26, 2008
with
the
SEC.
Note
3. Merger with Public Company and Reorganization
On
September 17, 2007, Transdel entered into an Agreement of Merger and Plan of
Reorganization (the “Merger Agreement”) by and among Transdel, Transdel
Pharmaceuticals Holdings, Inc., a privately held Nevada corporation (“Transdel
Holdings”), and Trans-Pharma Acquisition Corp., a newly formed, wholly owned
Delaware subsidiary of Transdel (“Acquisition Sub”). Upon closing of the merger
transaction contemplated under the Merger Agreement (the “Merger”), Acquisition
Sub merged with and into Transdel Holdings, and Transdel Holdings, as the
surviving corporation, became a wholly owned subsidiary of
Transdel.
In
connection with the Merger, 1,849,993 of Transdel common shares remain
outstanding and all other outstanding shares of Transdel were cancelled. Also,
at the closing of the Merger, each share of Transdel Holdings common stock
issued and outstanding immediately prior to the closing of the Merger was
exchanged for the right to receive 0.15625 of one share of Transdel’s common
stock. An aggregate of 8,000,000 shares of Transdel’s common stock, which
includes 195,313 shares of restricted stock which are subject to forfeiture,
were issued to the holders of Transdel Holdings’ common stock. As a result of
the transaction, the former owners of Transdel Holdings became the controlling
stockholders of Transdel. Accordingly, the merger of Transdel Holdings and
Transdel is a reverse merger that has been accounted for as a recapitalization
of Transdel Holdings.
Effective
on September 17, 2007, and for all reporting periods thereafter, Transdel’s
operating activities, including any prior comparative period, will include
only
those of Transdel Holdings. All references to shares and per share amounts
in
the accompanying condensed consolidated financial statements have been restated
to reflect the aforementioned share exchange.
5
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
4. Summary of Significant Accounting Policies
Going
Concern.
The
accompanying unaudited condensed consolidated financial statements have been
prepared on a going-concern basis, which contemplates the realization of assets
and the satisfaction of liabilities in the normal course of business. The
Company has incurred recurring operating losses, had negative operating cash
flows and has not recognized any revenues since July 24,
1998 ("Inception"). In addition, the Company had a deficit accumulated
during the development stage of $7,350,266 at March 31, 2008. These factors
raise substantial doubt about the Company’s ability to continue as a going
concern.
The
Company's continuation as a going concern is dependent on its ability to obtain
additional financing to fund operations, implement its business model, and
ultimately, to attain profitable operations. The Company intends to raise
additional financing to fund its operations. However, there is no assurance
that
sufficient financing will be available or, if available, on terms that would
be
acceptable to the Company.
The
unaudited condensed consolidated financial statements do not include any
adjustments relating to the recoverability and classification of recorded asset
amounts or the amounts and classification of liabilities that might be necessary
should the Company be unable to continue as a going concern.
Development
Stage Enterprise.
The
Company is a development stage company as defined in Statement of Financial
Accounting Standards (“SFAS”) No. 7, Accounting
and Reporting by Development Stage Enterprises.
The
Company is devoting substantially all of its present efforts to establish a
new
business, and its planned principal operations have not yet commenced. All
losses accumulated since Inception have been considered as part of the Company’s
development stage activities.
Research
and Development.
Research
and development costs are charged to expense when incurred.
Cash
and cash equivalents.
Cash
equivalents consist of highly liquid investments with maturities of three months
or less from the original purchase date.
Concentrations
of Credit Risk. Financial
instruments that potentially subject the Company to a concentration of credit
risk consist primarily of cash and cash equivalents. In order to minimize the
Company’s risk related to the cash equivalents, they are maintained in a money
market demand account. Due to the short-term nature of this investment, the
Company believes that there is no material exposure to interest rate risk.
The
Company maintains its cash and cash equivalents at a high-quality institution
that is insured by the Federal Deposit Insurance Corporation (“FDIC”).
Fair
Value of Financial Instruments.
The fair
values of the Company’s cash and cash equivalents, accounts payable and accrued
expenses approximate carrying values due to their short maturities.
Beneficial
Conversion Feature.
The
convertible features of the convertible notes provided for a rate of conversion
that was below market value (see Note 5). Such feature is normally characterized
as a "beneficial conversion feature" ("BCF"). Pursuant to Emerging Issues Task
Force Issue (“EITF”) No. 98-5 Accounting
For Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratio, and
EITF
No. 00-27, Application
of EITF Issue No. 98-5 To Certain Convertible Instruments, the
relative fair values of the BCFs have been recorded as a discount from the
face
amount of the respective debt instrument. The Company recorded the
corresponding debt discount related to the BCF as interest expense when the
related instrument was converted into the Company's common stock.
6
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
4. Summary of Significant Accounting Policies,
continued
Revenue
Recognition.
The
Company will recognize revenues in accordance with the SEC Staff Accounting
Bulletin (“SAB”) No. 101, Revenue
Recognition,
as
amended by SAB No. 104. SAB No. 104 requires that four basic criteria must
be
met before revenue can be recognized: (1) persuasive evidence of an arrangement
exists; (2) delivery has occurred; (3) the selling price is fixed and
determinable; and (4) collectibility is reasonably assured. Determination of
criteria (3) and (4) will be based on management's judgments regarding the
fixed
nature of the selling prices of the products delivered and the collectibility
of
those amounts. Provisions for discounts and rebates to customers, estimated
returns and allowances, and other adjustments will be provided for in the same
period the related sales are recorded. The Company will defer any revenue for
which the product has not been delivered or for which services have not been
rendered or are subject to refund until such time that the Company and the
customer jointly determine that the product has been delivered or services
have
been rendered or no refund will be required.
As
of
March 31, 2008, the Company had not generated any revenues and the Company
does
not anticipate that it will generate any revenues until one or more of its
drug
candidates are approved by the U.S. Food and
Drug Administration ("FDA") and effective sales and marketing support
are in place. The FDA approval process is highly uncertain and the Company
cannot estimate when it will generate revenues at this time.
Stock-Based
Compensation.
Effective January 1, 2006, the Company adopted SFAS No. 123 (revised
2004), Share-Based
Payment,
(‘‘SFAS 123R’’), which is a revision of SFAS No. 123, Accounting
for Stock-Based Compensation.
SFAS
123R supersedes Accounting Principles Board Opinion (“APB”) No. 25, Accounting
for Stock Issued to Employees,
and
amends SFAS No. 95, Statement
of Cash Flows.
SFAS
123R requires all share-based payments to employees, including grants of
employee stock options and restricted stock grants, to be recognized in the
financial statements based upon their fair values. The Company recorded total
stock-based compensation of $144,051, $0 and $328,573 for the three months
ended
March 31, 2008 and 2007 and for the period from Inception to March 31, 2008,
respectively, for options and restricted stock granted and vested which is
included in general and administrative expenses and research and development
expenses in the amount of $57,774 and $86,277, respectively, for the three
months ended March 31, 2008 and $121,353 and $207,220, respectively, for the
period from Inception to March 31, 2008. The fair value of the unvested stock
options and restricted stock grants amounted to $965,398 as of March 31,
2008.
The
Company's accounting policy for equity instruments issued to consultants and
vendors in exchange for goods and services follows the provisions of SFAS No.
123, EITF 96-18, Accounting
for Equity Instruments That are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services,
and EITF
00-18, Accounting
Recognition for Certain Transactions Involving Equity Instruments Granted to
Other Than Employees. As
such,
the value of the applicable stock-based compensation is periodically remeasured
and income or expense is recognized during their vesting terms. The
measurement date for the fair value of the equity instruments issued is
determined at the earlier of (i) the date at which a commitment for performance
by the consultant or vendor is reached or (ii) the date at which the consultant
or vendor's performance is complete. In the case of equity instruments issued
to
consultants, the fair value of the equity instrument is recognized over the
term
of the consulting agreement. In accordance with EITF 00-18, an asset acquired
in
exchange for the issuance of fully vested, nonforfeitable equity instruments
should not be presented or classified as an offset to equity on the grantor's
balance sheet once the equity instrument is granted for accounting purposes.
Accordingly, the Company recorded the fair value of the common stock issued
for
future consulting services as prepaid consulting fees in its condensed
consolidated balance sheets (see Note 6).
7
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
4. Summary of Significant Accounting Policies,
continued
Basic
and Diluted Loss per Common Share.
In
accordance with SFAS No. 128, Earnings
Per Share,
and SAB
No. 98, basic net loss per common share is computed by dividing net loss for
the
period by the weighted average number of common shares outstanding during the
period. Under SFAS No. 128, diluted net loss per share is computed by
dividing the net loss for the period by the weighted average number of common
and common equivalent shares, such as stock options and warrants outstanding
during the period.
Basic
and
diluted net loss applicable to common stock per share is computed using the
weighted average number of common shares outstanding during the period. Common
stock equivalents (prior to application of the treasury stock, if converted
method) from stock options, warrants and convertible notes were 1,180,458 and
99,914 for the three months ended March 31, 2008 and 2007, respectively, are
excluded from the calculation of diluted net loss per share for all periods
presented because the effect is anti-dilutive.
Use
of Estimates.
The
preparation of financial statements in conformity with GAAP requires management
to make estimates and judgments that affect the reported amounts of assets,
liabilities and disclosure of contingent assets and liabilities at the date
of
the financial statements and reported amounts of revenues and expenses during
the reporting periods. Significant estimates made by management are, among
others, the valuation and realizability of contributed services, stock options,
deferred taxes and stock-based compensation issued to non-employees. Actual
results could differ from those estimates.
Note
5. Notes Payable
In
August
2005, the Company issued seven convertible promissory notes in the aggregate
amount of $226,300 to various stockholders (collectively the “Stockholders’
Notes”). The Stockholders’ Notes bore interest at 4% per annum and were to
mature on August 25, 2010. In connection with the issuance of the Stockholders’
Notes, the Company granted warrants that were exercisable into an aggregate
35,359 shares of the Company’s common stock. The warrants were determined to
have an insignificant fair value.
In
May
2007, the holders of the Stockholders’ Notes and related warrants forgave the
amounts due and forfeited the related warrants. In connection with the
forgiveness, the Company recorded additional paid-in capital of $241,701 equal
to the value of the Stockholders’ Notes and related accrued interest. Interest
expense on the Stockholders’ Notes was $2,207 and $15,401 for the three months
ended March 31, 2007 and the period from Inception to March 31, 2008,
respectively.
In
May
and June 2007, the Company issued convertible notes payable to various lenders
for an aggregate amount of $1,500,000 (collectively, the “2007 Notes”). Each of
the 2007 Notes included interest at 7% per annum and were to mature on December
16, 2007 ("Maturity Date"). However, as a result of the Merger and Private
Placement (see Note 6), the entire outstanding principal amount and accrued
interest was converted into the Company’s common stock at a conversion price
equal to $1.00 per share, which resulted in the issuance of 1,530,177 shares.
Also, the Company recorded a debt discount of $1,530,177, which was amortized
immediately to interest expense upon the conversion of the 2007 Notes. Excluding
the debt discount, interest expense on the 2007 Notes was $30,177 for the period
from Inception to March 31, 2008.
8
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
6. Stockholders’ Equity
Concurrent with the Merger, the Company sold 2,071,834 shares of common stock for gross proceeds of $4,143,667 through a private placement (the “Private Placement”). In addition, the investors received warrants to purchase 517,958 shares of common stock for a period of five years at a cash and cashless exercise price of $4.00 and $5.00 per share, respectively. In connection with the Private Placement, the Company incurred placement agent fees and other related expenses totaling $342,105 and issued warrants to purchase up to 33,750 shares of common stock for a period of three years at a cash and cashless exercise price of $4.00 and $5.00 per share, respectively.
In
September 2007, the Company entered into three, one-year consulting agreements
with three separate firms to provide services related to investor
communications. The terms per one of the agreements, among other items, include
monthly payments of $7,500 plus expenses and for another agreement a
non-refundable fee of $140,000. Also, in the aggregate, 275,000 shares of common
stock were issued in accordance with the terms of the agreements along with
a
warrant to purchase 18,750 shares of common stock for a period of five years
at
a cash and cashless exercise price of $4.00 and $5.00, respectively. The fair
value of the stock and warrants were valued at
$550,000. The estimated costs of the consulting agreements, including the stock,
warrants and non-refundable fee are being amortized over the one-year
terms.
In
accordance with EITF 00-18, 100,000 of the 275,000 shares of common stock are
subject to remeasurement on a periodic basis as the performance condition for
these shares is not satisfied until the end of the contract term. The
remeasurement for the 100,000 shares was completed in two stages as follows:
a)
In February 2008, the consulting agreement associated with these shares was
terminated and as a condition of the termination, the firm retained 50,000
shares and transferred the remaining 50,000 shares to another firm. Therefore,
since the performance obligation related to the 50,000 shares, retained by
the
terminated consulting firm, is complete, they were revalued as of the February
termination date to $60,000, which was the fair market value of the shares
on
the termination date, and b) the remaining 50,000 shares that were transferred
to the other firm will be utilized for the payment of investor communications
services to be provided through September 2008. In accordance with the related
agreement, the Company initially recorded the value of these shares at $100,000,
which was revalued at March 31, 2008 to $87,500 (the estimated fair market
value
based on the closing market price). In the aggregate, the remeasurement of
the
50,000 shares earned and the transfer of the remaining 50,000 shares resulted
in
a reduction of additional paid in capital of $52,500 ($200,000 original value
less $147,500 remeasured value). For the three months ended March 31, 2008
and
2007 and for the period from Inception through March 31, 2008, the Company
amortized $137,627, $0 and $338,879, respectively, of prepaid consulting
fees which is included as part of selling, general and administrative expenses.
Note
7. Stock Option Plans
On
September 17, 2007, the Company’s board of directors and stockholders adopted
the 2007 Incentive Stock and Awards Plan (the “Plan”), which provides
for the issuance of a maximum of 1,500,000 shares of Common Stock.
The
purpose of the Plan is to provide an incentive to attract and retain directors,
officers, consultants, advisors and employees whose services are considered
valuable, to encourage a sense of proprietorship and to stimulate an active
interest of such persons into the Company’s development and financial success.
Under the Plan, the Company is authorized to issue incentive stock options
intended to qualify under Section 422 of the Code, non-qualified stock options
and restricted stock. The Plan will be administered by the Company’s Board of
Directors until such time as such authority has been delegated to a committee
of
the board of directors.
Pursuant
to the terms of the Private Placement, for one year following the initial
closing of the Private Placement the Company may not issue options to purchase
shares of common stock at an exercise price below $2.00 per share. In addition,
for
a
period of 18 months following the initial closing of the Private Placement,
the
Company may not file a registration statement, including, without limitation,
a
registration statement on Form S-8, covering the resale of any shares of common
stock issued pursuant to an employee benefit plan.
9
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
7. Stock Option Plans,
continued
A
summary
of the status of the Plan for the three months ended March 31, 2008 is as
follows:
Number
of Shares |
Weighted
Average Exercise Price |
||||||
Options
outstanding – Beginning of Period
|
610,000
|
$
|
2.01
|
||||
Granted
|
-
|
-
|
|||||
Exercised
Cancelled
|
-
-
|
-
-
|
|||||
Options
outstanding – End of Period
|
610,000
|
$
|
2.01
|
||||
Options
exercisable – End of Period
|
-
|
||||||
Weighted
average remaining contractual life of the outstanding options – End
of period
|
9.5
years
|
||||||
Aggregate
intrinsic value – End of Period
|
-
|
All
options granted to date expire on the ten year anniversary of the issuance
date
and vest over one to three years. The Company uses the
Black-Scholes option pricing model to estimate the grant-date fair value of
share-based awards under SFAS 123R. The Black-Scholes model requires subjective
assumptions regarding future stock price volatility and expected time to
exercise, along with assumptions about the risk-free interest rate and expected
dividends, which affect the estimated fair values of the Company’s stock-based
awards. The expected term of options granted was determined in accordance with
the simplified approach as defined by SAB No. 107, Share-Based
Payment,
as the
Company has very limited historical data on employee exercises and post-vesting
employment termination behavior. The expected volatility is based on the
historical volatilities of the common stock of comparable publicly traded
companies based on the Company’s belief that it currently has limited historical
data regarding the volatility of its stock price on which to base a meaningful
estimate of expected volatility. The risk-free rate selected to value any
particular grant is based on the U.S. Treasury rate that corresponds to the
expected term of the grant effective as of the date of the grant. The Company
used 0% as an expected dividend yield assumption. These factors could change
in
the future, affecting the determination of stock-based compensation expense
in
future periods. Utilizing these assumptions, the fair value is determined at
the
date of grant. In accordance with SFAS 123R, the financial statement effect
of
forfeitures is estimated at the time of grant and revised, if necessary, if
the
actual effect differs from those estimates. As of March 31, 2008, management
estimates that the effect of forfeitures on the financial statements will be
insignificant. As of March 31, 2008, there was approximately $729,000 of total
unrecognized compensation expense related to unvested stock-based compensation
under the Plan. That expense is expected to be recognized over the
weighted-average period of 2.4 years.
Furthermore,
in August 2007, the Company issued a restricted stock grant to an executive
of
the Company for 195,313 shares of the Company’s common stock upon closing of the
Merger (See Note 3). The restricted stock grant will vest 100% on March 17,
2009
(18 months subsequent to the closing of the Merger). The fair value of the
grant
was determined to be approximately $391,000 and will be amortized over the
period of time prior to the vesting date. As of March 31, 2008, there was
approximately $236,000 of total unrecognized compensation expense related to
the
unvested restricted stock grant. Subsequent to March 31, 2008, the restrictions
on the restricted stock were waived in connection with the executive’s
resignation (see Note 11).
10
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
8. Stock Warrants
In addition to the warrants issued in conjunction with the Private Placement, the Company issued a warrant to purchase shares of its common stock to a firm in connection with a consulting agreement at an exercise price of $4.00 (or cashless exercise price of $5.00). The expiration of the outstanding warrants occurs through September 2012 at various periods (see Note 6).
A
summary
of the status of the warrants for the period ended March 31, 2008, is as
follows:
Number of
Shares Subject to Warrants Outstanding |
Weighted-
Average Exercise Price |
||||||
Warrants
outstanding – Beginning of Period
|
570,458
|
$
|
4.00
|
||||
Granted
|
-
|
-
|
|||||
Exercised
|
-
|
-
|
|||||
Expired
|
-
|
-
|
|||||
Warrants
outstanding – End of Period
|
570,458
|
$
|
4.00
|
||||
Weighted
average remaining contractual life of the outstanding warrants – End
of Period
|
4.35
years
|
Note
9. Recent Accounting Pronouncements
The
following pronouncements have been issued by the Financial Accounting Standards
Board (“FASB”):
In
June
2007, the FASB ratified a consensus opinion reached on EITF Issue No. 07-3,
Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities.
The
guidance in EITF Issue No. 07-3 requires the Company to defer and capitalize
nonrefundable advance payments made for goods or services to be used in research
and development activities until the goods have been delivered or the related
services have been performed. If the goods are no longer expected to be
delivered nor the services expected to be performed, the Company would be
required to expense the related capitalized advance payments. The consensus
in
EITF Issue No. 07-3 is effective for fiscal years, and interim periods within
those fiscal years, beginning after December 15, 2007 and is to be applied
prospectively to new contracts entered into on or after December 15, 2007.
The
Company adopted EITF Issue No. 07-3 effective January 1, 2008. The impact of
applying this consensus will depend on the terms of the Company’s future
research and development contractual arrangements.
In
December 2007, the FASB issued SFAS No. 141R, "Business
Combinations."
SFAS
No. 141R provides companies with principles and requirements on how an acquirer
recognizes and measures in its financial statements the identifiable assets
acquired, liabilities assumed, and any noncontrolling interest in the acquiree
as well as the recognition and measurement of goodwill acquired in a business
combination. SFAS No. 141R also requires certain disclosures to enable users
of
the financial statements to evaluate the nature and financial effects of the
business combination. Acquisition costs associated with the business combination
will generally be expensed as incurred. SFAS No. 141R is effective for business
combinations occurring in fiscal years beginning after December 15, 2008. Early
adoption of SFAS No. 141R is not permitted. The Company is currently evaluating
the impact SFAS No. 141R will have on any future business
combinations.
11
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
9. Recent Accounting Pronouncements, continued
Other
recent accounting pronouncements issued by the FASB (including the EITF) and
the
American Institute of Certified Public Accountants did not or are not believed
by management to have a material impact on the Company’s present or future
consolidated financial statements.
Note
10. Commitments and Contingencies
Indemnities
and Guarantees
The
Company has made certain indemnities and guarantees, under which it may be
required to make payments to a
guaranteed or indemnified party, in relation to certain actions or transactions.
The Company indemnifies its directors, officers, employees and agents, as
permitted under the laws of the State of Delaware. The duration of the
guarantees and indemnities varies, and is generally tied to the life of the
agreement. These guarantees and indemnities do not provide for any limitation
of
the maximum potential future payments the Company could be obligated to make.
Historically, the Company has not been obligated nor incurred any payments
for
these obligations and, therefore, no liabilities have been recorded for these
indemnities and guarantees in the accompanying balance sheet.
Mediation
Settlement
On
February 5, 2008, as a result of mediation, the Company and a previously
retained law firm reached an agreement related to certain alleged claims the
Company had against the law firm. Although the law firm did not admit to any
liability or wrongdoing, they desired to resolve the dispute and therefore,
agreed to pay the Company $750,000. In exchange for the settlement, the Company,
the law firm and any other parties involved in the mediation, released and
waived any future claims against each other, whether known or unknown at the
time of the settlement. The net amount received by the Company was $375,000
after fees paid to the Company’s counsel and an executive and director of the
Company. The fees paid to the executive and director, which were previously
approved by the Board of Directors, are due to their monetary contributions
and
uncompensated time commitment over a period of approximately four years related
to pursuing this matter and other amounts paid on the Company’s behalf prior to
the Merger.
Note
11. Subsequent Events
Restricted
Stock
On
April
4, 2008, the Company’s Board of Directors waived any restrictions or forfeiture
conditions on the 195,313 shares of restricted common stock previously granted
to an executive (see Note 7) in conjunction with the executive’s resignation and
a separation agreement entered into between the Company and the executive.
As of
March 31, 2008, the unamortized value of the restricted stock was $236,000
which
will be fully amortized in April 2008 as a result of the waiver of restrictions
and the executive’s resignation from the Company.
12
TRANSDEL
PHARMACEUTICALS, INC.
(A
Development Stage Company)
NOTES
TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
Note
11. Subsequent Events, continued
Stock
Option Grants
On
April
24, 2008, the Company’s Board of Directors granted 600,000 stock options to
certain executive officers of the Company under the Company’s 2007
Incentive Stock and Awards Plan. All of the options were granted with an
exercise price of $2.00 and have a ten year life. Also, the
options vest one-twelfth per quarter commencing on the first full quarter after
the initial grant date of April 24, 2008.
Furthermore,
on April 24, 2008, the Company’s Board of Directors modified the vesting
provisions of all outstanding stock options previously granted to vest on a
quarterly basis over the respective vesting period as opposed to on an annual
basis.
Consulting
Agreement
On
April
24, 2008, the Company entered into a one-year consulting agreement with a firm
to provide the Company with financial advisory services. As compensation for
the
services, the Company issued three-year warrants to purchase 5,000 shares of
the
Company’s common stock at a cashless price of $2.00 per share.
2008
Private Placement
On
May
12, 2008, the Company sold 1,818,180 shares of common stock for gross proceeds
of $4,000,000 through a private placement to accredited investors. In addition,
the investors received warrants to purchase 227,272 shares of common stock
for a
period of five years at a cash and cashless exercise price of $4.40 and $5.50
per share, respectively.
13
Item
2. Management’s Discussion and Analysis of Financial Condition and
Results of Operations
Overview
We
are a
specialty pharmaceutical company focused on the development and
commercialization of non-invasive topically delivered medications. Our lead
topical drug, Ketotransdel™, utilizes our proprietary Transdel™ cream
formulation to facilitate the passage of ketoprofen, a non-steroidal
anti-inflammatory drug (“NSAID”), through the skin barrier to reach targeted
underlying tissues where the drug exerts its prolonged localized
anti-inflammatory and analgesic effect. A Phase 1/2 clinical trial supported
the
safety and efficacy of Ketotransdel™ for acute pain and muscle soreness.
Plan
of Operations
For
the next twelve months, our current operating plan is focused on the development
of our lead drug, Ketotransdel™. In April 2008, we announced that based on
the U.S. Food and Drug Administration’s (“FDA”) review of our Phase 3
submission we can initiate our Phase 3 clinical program for our novel
topical cream based NSAID, Ketotransdel™. The
Phase
3 program will consist of a randomized, double-blind, placebo controlled trial
to evaluate the efficacy and safety of Ketotransdel™ in acute soft tissue
injuries of the upper and lower extremities over a one week treatment period
with a one week post-treatment follow-up. The multi-center trial will be
conducted in approximately 25 - 30 sites, mainly in the United States and
potentially in Canada, and will enroll approximately 300 patients, randomized
1:1 ratio Ketotransdel™ (active) versus placebo vehicle (identical to active
without the drug ketoprofen). The primary efficacy endpoint is the difference
in
the change of baseline of pain during normal activity between active and placebo
measured by using the Visual Analogue Scale (VAS), a well known and validated
instrument for pain measurement. We intend to initiate the Phase 3 program
in
the second quarter of 2008. In addition, we will be planning to initiate another
clinical study, possibly in osteoarthritis patients, to further support our
registration program for Ketotransdel™ in the United States. We would anticipate
reporting top-line results in the second half of 2009.
If
and
when the FDA approves Ketotransdel™ for treatment of acute pain, we intend
to pursue FDA approval of Ketotransdel™ for other indications. We believe that
the clinical success of Ketotransdel™ will facilitate the use of the Transdel™
delivery technology in other products. We are also investigating other
drug candidates and treatments for transdermal delivery using the Transdel™
platform technology for products in pain management and other therapeutic areas.
Furthermore,
we are exploring potential partnerships with U.S. and foreign based companies
that have sales and marketing infrastructures to support Ketotransdel™ in the
event that the product is approved and commercialized. We are also looking
to
out-license our Transdel™ drug delivery technology for the development and
commercialization of additional innovative drug products. There can be no
assurance that any of these activities will lead to definitive
agreements.
We
believe that our current staff is sufficient to carry out our business plan,
however, if our operations in the future require it, we will consider the
employment of additional staff.
Liquidity
and Capital Resources
Since
July 24, 1998 ("Inception") through March 31, 2008, we have incurred
losses of approximately $7.4 million. These losses are primarily due to general
and administrative and research and development expenses. Historically, our
operations have been financed through capital contributions and debt and equity
financings.
As
of
March 31, 2008, we had $3.4 million in cash. On each of September 17, 2007,
and
October 10, 2007, we completed private placements to selected institutional
and individual investors of our common stock and warrants. In connection
with the private placements, we raised approximately $3.8 million (net of
placement agent fees and other costs aggregating $342,105) from the issuance
of
2,071,834 shares of common stock and detachable redeemable warrants to purchase
517,958 shares of our common stock at a cash exercise price of $4.00 per share
and a cashless exercise price of $5.00 per share. In
May
2008, we completed another private placement to accredited investors, where
we
raised gross proceeds of $4.0 million from the issuance of 1,818,180 shares
of
common stock and detachable warrants to purchase 227,272 shares of our common
stock at a cash exercise price of $4.40 per share and a cashless exercise price
of $5.50 per share.
We
are
assessing our financing needs for the foreseeable future. In order to
execute our operating plan over the next twelve months, which includes the
expected initiation and conduct of the Phase 3 clinical program, additional
financing, including,
and without limitation to, equity or debt financing, funding from a
corporate partnership or licensing arrangement or any similar
financing, will be required. There can be no assurance that such
financing will be available on terms favorable to us or at all. If adequate
financing is not available, we will have to delay, postpone or terminate
the clinical program and curtail general and administrative operations, which
would have a material adverse effect on us.
14
Critical
Accounting Policies
We
rely
on the use of estimates and make assumptions that impact our financial
condition and results. These estimates and assumptions are based on historical
results and trends as well as our forecasts as to how results and trends
might change in the future. Although we believe that the estimates we
use are reasonable, actual results could differ from those
estimates.
We
believe that the accounting policies described below are critical to
understanding our business, results of operations and financial condition
because they involve more significant judgments and estimates used in the
preparation of our consolidated financial statements. An accounting policy
is
deemed to be critical if it requires an accounting estimate to be made based
on
assumptions about matters that are highly uncertain at the time the estimate
is
made, and any changes in the different estimates that could have been used
in
the accounting estimates that are reasonably likely to occur periodically could
materially impact our consolidated financial statements.
Stock-Based
Compensation.
Effective January 1, 2006, we adopted Statement of Financial
Accounting Standards (“SFAS”) No. 123 (revised 2004), Share-Based
Payment,
(“SFAS 123R”), which is a revision of SFAS No. 123, Accounting
for Stock-Based Compensation.
SFAS
123R supersedes Accounting Principles Board No. 25, Accounting
for Stock Issued to Employees,
and
amends SFAS No. 95, Statement
of Cash Flows.
SFAS
123R requires all share-based payments to employees, including grants of
employee stock options and restricted stock grants, to be recognized in the
financial statements based upon their fair values. We use the Black-Scholes
option pricing model to estimate the grant-date fair value of share-based awards
under SFAS 123R. Fair value is determined at the date of grant. In accordance
with SFAS 123R, the financial statement effect of forfeitures is estimated
at
the time of grant and revised, if necessary, if the actual effect differs from
those estimates. As of March 31, 2008, management estimates that the effect
of
forfeitures on the financial statements will be insignificant.
Our
accounting policy for equity instruments issued to consultants and vendors
in
exchange for goods and services follows the provisions of SFAS No. 123, Emerging
Issues Task Force (“EITF”) 96-18, Accounting
for Equity Instruments That are Issued to Other Than Employees for Acquiring,
or
in Conjunction with Selling, Goods or Services
and EITF
00-18, Accounting
Recognition for Certain Transactions Involving Equity Instruments Granted to
Other Than Employees.
As such,
the value of the applicable stock-based compensation is periodically remeasured
and income or expense is recognized during the vesting terms. The measurement
date for the fair value of the equity instruments issued is determined at the
earlier of (i) the date at which a commitment for performance by the consultant
or vendor is reached or (ii) the date at which the consultant or vendor's
performance is complete. In the case of equity instruments issued to
consultants, the fair value of the equity instrument is recognized over the
term
of the consulting agreement. In accordance with EITF 00-18, an asset acquired
in
exchange for the issuance of fully vested, nonforfeitable equity instruments
should not be presented or classified as an offset to equity on the grantor's
balance sheet once the equity instrument is granted for accounting purposes.
Accordingly, we recorded the fair value of the common stock issued for
future consulting services as prepaid consulting fees in our consolidated
balance sheet.
15
Beneficial
Conversion Feature.
The
convertible features of the convertible notes provided for a rate of conversion
that was below market value (see Note 5). Such feature is normally characterized
as a “beneficial conversion feature” (“BCF”). Pursuant to EITF No. 98-5
Accounting
For Convertible Securities with Beneficial Conversion Features or Contingently
Adjustable Conversion Ratio
and EITF
No. 00-27, Application
of EITF Issue No. 98-5 To Certain Convertible Instruments, the
relative fair values of the BCFs have been recorded as a discount from the
face
amount of the respective debt instrument. We recorded the corresponding
debt discount related to the BCF as interest expense, in fiscal year 2007,
when
the related instrument was converted into its common stock.
Off-Balance
Sheet Arrangements
Since our
inception, except for standard operating leases, we have not engaged
in any off-balance sheet arrangements, including the use of structured finance,
special purpose entities or variable interest entities.
Recent
Accounting Pronouncements
In
June
2007, the FASB ratified a consensus opinion reached on EITF Issue No. 07-3,
Accounting
for Nonrefundable Advance Payments for Goods or Services Received for Use in
Future Research and Development Activities.
The
guidance in EITF Issue No. 07-3 requires us to defer and capitalize
nonrefundable advance payments made for goods or services to be used in research
and development activities until the goods have been delivered or the related
services have been performed. If the goods are no longer expected to be
delivered nor the services expected to be performed, we would be required to
expense the related capitalized advance payments. The consensus in EITF Issue
No. 07-3 is effective for fiscal years, and interim periods within those fiscal
years, beginning after December 15, 2007 and is to be applied prospectively
to
new contracts entered into on or after December 15, 2007. We adopted EITF Issue
No. 07-3 effective January 1, 2008. The impact of applying this consensus will
depend on the terms of our future research and development contractual
arrangements.
In
December 2007, the FASB issued SFAS No. 141R, Business
Combinations.
SFAS
No. 141R provides companies with principles and requirements on how an acquirer
recognizes and measures in its financial statements the identifiable assets
acquired, liabilities assumed, and any noncontrolling interest in the acquiree
as well as the recognition and measurement of goodwill acquired in a business
combination. SFAS No. 141R also requires certain disclosures to enable users
of
the financial statements to evaluate the nature and financial effects of the
business combination. Acquisition costs associated with the business combination
will generally be expensed as incurred. SFAS No. 141R is effective for business
combinations occurring in fiscal years beginning after December 15, 2008. Early
adoption of SFAS No. 141R is not permitted. We are currently evaluating the
impact SFAS No. 141R will have on any future business combinations.
As
required by Commission Rule 13a-15(b), we carried out an evaluation, under
the supervision and with the participation of our management, including our
Chief Executive Officer and the Chief Financial Officer, of the effectiveness
of
the design and operation of our disclosure controls and procedures as of
the end of the quarter covered by this quarterly report on Form 10-Q. Based
on
the foregoing, our Chief Executive Officer and Chief Financial Officer
concluded that our disclosure controls and procedures were effective at the
reasonable assurance level.
16
There
has
been no change in our internal control over financial reporting
during our most recent fiscal quarter that has materially affected, or is
reasonably likely to materially affect, our internal control over financial
reporting.
PART
II
OTHER
INFORMATION
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
Except
as
previously included in our Current Reports on Form 8-K filed with the
Securities and Exchange Commission, we have not sold any equity securities
during the period covered by this quarterly report on Form 10-Q that were not
registered under the Securities Act of 1933, as amended.
Item
6. Exhibits
Exhibit
Number
|
Description
|
|
31.1*
|
Section
302 Certification of Principal Executive Officer
|
|
31.2*
|
Section
302 Certification of Principal Financial Officer
|
|
32.1*
|
Section
906 Certification of Principal Executive Officer and Principal Financial
Officer
|
*
|
Filed
herewith.
|
17
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
Transdel
Pharmaceuticals, Inc.
|
||
Dated:
May 15, 2008
|
By:
|
/s/
Juliet Singh
|
Juliet
Singh, Ph.D.
Chief
Executive Officer
(Principal
Executive Officer)
|
18
EXHIBIT
INDEX
Exhibit
Number
|
Description
|
|
31.1*
|
Section
302 Certification of Principal Executive Officer
|
|
31.2*
|
Section
302 Certification of Principal Financial Officer
|
|
32.1*
|
Section
906 Certification of Principal Executive Officer and Principal Financial
Officer
|
*
|
Filed
herewith.
|