U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended JUNE 30, 2003
----------------------
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
For the transition period from ________ to ________
Commission file number 33-23693
-------------------------------
ENTROPIN, INC.
--------------
(Exact name of small business issuer as specified in its charter)
DELAWARE 68-0150827
- --------------------------------------------------------------------------------
(State or other jurisdiction of (IRS employer Identification No.)
incorporation or organization)
45926 Oasis Street, Indio, CA 92201
-----------------------------------
(Address of principal executive offices)
(760) 775-8333
--------------
(Issuer's telephone number)
N/A
---
(Former name, former address and former fiscal year,
if changed since last report)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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.
(1) Yes _X_ No __; (2) Yes _X_ No __
As of July 31, 2003, 10,283,587 shares of the issuer's Common Stock, $.0001 par
value per share, were outstanding.
Transitional Small Business Disclosure Format Yes __ No _X_
INDEX
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PART I. FINANCIAL INFORMATION
- ------- ---------------------
Item 1. Financial Statements
Balance Sheets - December 31, 2002 and June 30, 2003 (unaudited) 2
Statements of Operations - For the Three Months Ended June 30,
2002 and 2003 (unaudited) 3
Statements of Operations - For the Six Months Ended June 30,
2002 and 2003 and for the Period from August 27, 1984
(Inception) through June 30, 2003 (unaudited) 4
Statement of Changes in Stockholders' Equity - For the Six
Months Ended June 30, 2003 (unaudited) 5
Statements of Cash Flows - For the Six Months Ended June 30,
2002 and 2003 and for the Period from August 27, 1984
(Inception) through June 30, 2003 (unaudited) 6
Notes to Financial Statements (unaudited) 8
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations 14
Item 3. Controls and Procedures 25
PART II. OTHER INFORMATION
- -------- -----------------
Item 1. Legal Proceedings 26
Item 2. Changes in Securities and Use of Proceeds 26
Item 3. Defaults upon Senior Securities 27
Item 4. Submission of Matters to a Vote of Security Holders 27
Item 5. Other Information 27
Item 6. Exhibits and Reports on Form 8-K 27
Signatures 29
PART I. Item 1
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
BALANCE SHEETS
December 31, 2002 and June 30, 2003
ASSETS December 31, 2002 June 30, 2003
- ------ ----------------- -------------
(Unaudited)
Current assets:
Cash and cash equivalents $ 2,906,853 $ 2,179,035
Short-term investments 990,000 --
Accrued interest receivable 5,954 --
Refundable deposits 3,126 103,126
------------- -------------
Total current assets 3,905,933 2,282,161
Patent costs, less accumulated amortization of
$163,869 (2002) and $181,379 (2003) 410,641 411,198
Property and equipment, net 12,210 8,876
------------- -------------
$ 4,328,784 $ 2,702,235
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY
- ------------------------------------
Current liabilities:
Accounts payable $ 62,450 $ 104,554
Series A redeemable preferred stock, $.0001 par value;
3,210,487 shares authorized, issued and outstanding,
$1.00 per share redemption value 3,210,487 --
Series B redeemable convertible preferred stock, $.0001 par value;
400,000 shares authorized, 143,500 (2002) and 128,500 (2003)
shares issued and outstanding, $5.00
per share redemption value 712,547 638,064
Contingencies (Note 2) -- --
Stockholders' equity:
Series A' redeemable preferred stock, $.0001 par value; 3,210,487 shares
authorized, issued and outstanding,
$1.00 per share redemption value -- 3,210,487
Common stock, $.0001 par value; 50,000,000 shares
authorized, 9,912,587 (2002) and 10,283,587 (2003)
shares issued and outstanding 991 1,028
Additional paid-in capital 29,801,165 30,023,201
Unearned stock compensation (72,479) (173)
Deficit accumulated during the development stage (29,386,377) (31,274,926)
------------- -------------
Total stockholders' equity 343,300 1,959,617
------------- -------------
$ 4,328,784 $ 2,702,235
============= =============
See accompanying notes to financial statements.
2
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
For the Three Months Ended June 30, 2002 and 2003
(Unaudited)
2002 2003
---- ----
Costs and expenses:
Research and development $ 1,053,647 $ 92,405
General and administrative 735,884 805,723
------------- -------------
Operating loss (1,789,531) (898,128)
Interest income 46,880 6,774
------------- -------------
Net loss (1,742,651) (891,354)
Dividends applicable to Series B
preferred stockholders (21,063) (16,063)
------------- -------------
Net loss applicable to common stockholders $ (1,763,714) $ (907,417)
============= =============
Basic and diluted net loss per common share $ (.18) $ (.09)
============= =============
Weighted average common shares outstanding 9,864,000 10,276,000
============= =============
See accompanying notes to financial statements.
3
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF OPERATIONS
For the Six Months Ended June 30, 2002 and 2003
and for the Period from August 27, 1984 (Inception) Through June 30, 2003
(Unaudited)
Inception through
2002 2003 June 30, 2003
------------- ------------- -------------
Costs and expenses:
Research and development $ 1,894,096 $ 504,467 $ 15,198,045
General and administrative 1,317,275 1,400,905 16,293,271
------------- ------------- -------------
Operating loss (3,211,371) (1,905,372) (31,491,316)
------------- ------------- -------------
Other income (expense):
Interest income 108,186 16,823 1,482,951
Interest expense -- -- (242,811)
------------- ------------- -------------
Total other income, net 108,186 16,823 1,240,140
------------- ------------- -------------
Net loss (3,103,185) (1,888,549) (30,251,176)
Dividends applicable to Series B
preferred stockholders (42,125) (32,750) (1,100,895)
------------- ------------- -------------
Net loss applicable to common stockholders $ (3,145,310) $ (1,921,299) $(31,352,071)
============= ============= =============
Basic and diluted net loss per common share $ (.32) $ (.19) $ (5.09)
============= ============= =============
Weighted average common shares outstanding 9,850,000 10,144,000 6,164,000
============= ============= =============
See accompanying notes to financial statements.
4
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENT OF CHARGES IN STOCKHOLDERS' EQUITY
for the Six Months Ended une 30, 2003
(Unaudited)
Series A' redeemable Additional
preferred stock Common stock paid-in
Shares Amount Shares Amount capital
------- ------- ------- ------- -------
Balance, January 1, 2003 -- $ -- 9,912,587 $ 991 $ 29,801,165
Conversion of Series A preferred stock to
Series A' preferred stock 3,210,487 3,210,487 -- -- --
Amortization and valuation adjustment of
unearned stock compensation -- -- -- -- 230
Shares issued for services -- -- 356,000 35 147,324
Conversion of Series B preferred stock to common stock -- -- 15,000 2 74,482
Net loss for the period -- -- -- -- --
------------ ------------ ------------ ------------ ------------
Balance, June 30, 2003 3,210,487 $ 3,210,487 10,283,587 $ 1,028 $ 30,023,201
============ ============ ============ ============ ============
(continued)
Deficit
accumulated
Unearned during the Total
stock development stockholders'
compensation stage equity
------------ ----- ------
Balance, January 1, 2003 $ (72,479) $(29,386,377) $ 343,300
Conversion of Series A preferred stock to
Series A' preferred stock -- -- 3,210,487
Amortization and valuation adjustment of
unearned stock compensation 72,306 -- 72,536
Shares issued for services -- -- 147,359
Conversion of Series B preferred stock to common stock -- -- 74,484
Net loss for the period -- (1,888,549) (1,888,549)
------------- ------------- -------------
Balance, June 30, 2003 $ (173) $(31,274,926) $ 1,959,617
============= ============= =============
See accompanying notes to financial statements.
5
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED JUNE 30, 2003 AND 2002
and for the Period from August 27, 1984 (Inception) Through June 30, 2003
(Unaudited)
Inception through
2002 2003 June 30, 2003
---- ---- -------------
Cash flows from operating activities:
Net loss $ (3,103,185) $ (1,888,549) $(30,251,176)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 17,687 20,845 244,225
Services received in exchange for stock,
stock options and warrants 306,308 219,895 10,084,233
Services received in exchange for
compensation agreements -- -- 2,231,678
Decrease in accrued interest receivable 9,423 5,954 --
Increase in refundable deposits -- (100,000) (100,000)
Increase in accounts payable 131,544 42,104 312,251
Other (83,421) -- 57,326
------------- ------------- -------------
Net cash used in D59operating activities (2,721,644) (1,699,751) (17,421,463)
------------- ------------- -------------
Cash flows from investing activities:
Maturities of short-term investments, net 2,102,352 990,000 --
Patent costs (36,255) (18,067) (592,577)
Purchase of property and equipment (4,658) -- (130,517)
------------- ------------- -------------
Net cash provided by (used in) investing activities 2,061,439 971,933 (723,094)
------------- ------------- -------------
Cash flows from financing activities:
Proceeds from shares issued pursuant to recapitalization -- -- 220,100
Proceeds from issuance of common stock and warrants -- -- 18,281,066
Proceeds from issuance of preferred stock -- -- 1,142,750
Proceeds from stockholder loans -- -- 809,676
Proceeds from stockholder advances -- -- 98,873
Repayments of stockholder advances -- -- (98,873)
Payment for cancellation of common stock warrant -- -- (330,000)
Proceeds from convertible notes payable -- -- 200,000
------------- ------------- -------------
Net cash provided by financing activities -- -- 20,323,592
------------- ------------- -------------
Net (decrease) increase in cash and cash equivalents (660,205) (727,818) 2,179,035
Cash and cash equivalents at beginning of period 4,609,562 2,906,853 --
------------- ------------- -------------
Cash and cash equivalents at end of period $ 3,949,357 $ 2,179,035 $ 2,179,035
============= ============= =============
See accompanying notes to financial statements.
6
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPNAY)
STATEMENTS OF CASH FLOWS
FOR THE SIX MONTHS ENDED JUNE 30, 2003 AND 2002
AND FOR THE PERIOD FROM AUGUST 27, 1984 (INCEPTION) THROUGH JUNE 30, 2003
(UNAUDITED)
(Continued from preceding page)
Supplemental disclosure of cash flow information:
Six Months Ended June 30, Inception through
2002 2003 June 30, 2003
---- ---- -------------
Cash paid for interest
during the period $ - $ - $ 242,811
Supplemental disclosure of non-cash investing and financing activities:
During the period from August 27, 1984 (inception) through June
30, 2003, the Company issued 3,210,487 shares of Series A
preferred stock in exchange for an aggregate $1,710,487 of notes
payable to stockholders plus accrued interest and a $1,500,000
compensation agreement.
During the period from August 27, 1984 (inception) through June
30, 2003, the Company converted promissory notes payable with
outstanding principal and interest balances totaling $201,662
into 100,831 shares of common stock.
During the period from August 27, 1984 (inception) through June
30, 2003, the Company issued 82,000 shares of common stock at
$5.00 per share as payment of accrued dividends on Series B
preferred stock.
During the six months ended June 30, 2002 and 2003, and the
period from August 27, 1984 (inception) through June 30, 2003,
the Company issued none, 15,000 and 127,000 shares of common
stock for conversion of an equal number of shares of Series B
preferred stock totaling $0, $79,448 and $572,766, respectively.
See accompanying notes to financial statements.
7
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
The accompanying financial statements of Entropin, Inc. (the "Company") have
been prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information and with the
instructions to Form 10-QSB and Item 310(b) of Regulation S-B. Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
condensed or omitted under such rules and regulations. Accordingly, they do not
include all of the information and footnotes required by accounting principles
generally accepted in the United States of America for complete financial
statements. In the opinion of management, the financial statements reflect all
adjustments considered necessary for a fair presentation. The results of
operations for the six months ended June 30, 2002 and 2003 are not necessarily
indicative of the results to be expected for the full year. For further
information, refer to the financial statements and footnotes thereto included in
our annual report on Form 10-KSB/A for the year ended December 31, 2002 as filed
with the Securities and Exchange Commission on April 30, 2003.
1. Organization and selected accounting policies
---------------------------------------------
Organization and basis of presentation:
Entropin, Inc. (the "Company"), a Delaware corporation, was organized as a
California corporation in August 1984. The Company is a pharmaceutical
research and development company focused on the development of its
proprietary compound ENT-103 as a potent therapy for pain. Activities from
inception include research and development, seeking the U.S. Food and Drug
Administration, or FDA, approval for its proprietary compounds, including
its current drug candidate, ENT-103, as well as fund raising.
The Company's financial statements have been presented on a going concern
basis which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company is in the
development stage and has been primarily involved in research and
development activities. This has resulted in significant operating losses
and an accumulated deficit at June 30, 2003 of $31,274,926. Management
anticipates additional operating losses for the foreseeable future. These
factors among others may indicate that the Company will be unable to
continue as a going concern for a reasonable period of time. The financial
statements do not include any adjustments related to the recoverability of
recorded asset amounts that may be necessary should the Company be unable
to continue as a going concern. The Company will need to raise significant
additional funds to continue its planned development activities. In the
absence of positive cash flows from operations, the Company is highly
dependent on its ability to secure additional funding through the issuance
of debt or equity instruments or corporate partnering arrangements. If
adequate funds are not available, the Company may be forced to
significantly curtail its operations or to obtain funds through entering
into collaborative agreements or other arrangements that may be on
unfavorable terms. The Company's failure to raise sufficient additional
funds on favorable terms, or at all, would have a material adverse effect
on its business, results of operations and financial position. The
Company's ultimate continued existence is currently dependent on its
ability to complete development of, obtain approval for, and successfully
market its proprietary compound ENT-103.
8
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
Because the Company has not yet completed product development, obtained
regulatory approval, or verified the market acceptance and demand for any
products it may develop, its activities have been accounted for as those of
a "development stage enterprise" as set forth in Statement of Financial
Accounting Standards No. 7, "Accounting and Reporting by Development Stage
Enterprises".
During 1998, the Company consummated an agreement and plan of merger with
Vanden Capital Group, Inc. ("Vanden"), a Colorado corporation, under which
Vanden acquired all of the issued and outstanding common shares of the
Company. The Company was merged into Vanden, and Vanden changed its name to
Entropin, Inc. For accounting purposes, the acquisition has been treated as
a recapitalization of the Company, based upon historical cost, and a
reverse acquisition with the Company as the acquirer.
During 1998, the Company also completed private offerings of 245,500 shares
of Series B convertible preferred stock for gross proceeds of $1,227,500,
$200,000 of convertible notes payable, and 1,508,700 shares of common stock
for gross proceeds of $4,664,800. During the first half of 2000, the
Company raised approximately $13,700,000 through a secondary offering and
sale of the underwriter's over-allotment.
Stockholders' equity:
As of June 30, 2003, 128,500 shares of the Company's Series B preferred
stock remained outstanding. On July 15, 2003, all outstanding shares of our
Series B preferred stock were subject to redemption at the original
purchase price of $5.00 per share, along with all accrued and unpaid
dividends. On July 18, 2003, the Company's Board of Directors resolved to
pay the final annual dividend with stock and authorized the issuance of
12,850 shares of the Company's common stock as payment for the final
dividend. On July 30, 2003, the Company sent each holder of Series B
preferred stock a recapitalization agreement, under which the Company
agreed to exchange each outstanding share of Series B preferred stock for
9.4967 shares of its common stock rather than redeeming the Series B
preferred stock for cash. As of August 11, 2003, the holders of all
outstanding shares of Series B preferred stock had agreed to exchange their
shares of Series B preferred stock for common stock pursuant to a
recapitalization agreement with the Company. As a result, there are no
longer any shares of Series B preferred stock outstanding as of August 11,
2003, and the Company's redemption obligation to the prior holders of
Series B preferred stock has terminated.
9
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
Use of estimates:
The preparation of financial statements in conformity with accounting
principles generally accepted in the United States of America requires
management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the financial statements and the reported
amounts of revenues and expenses during the reporting period. Actual
results could differ from those estimates.
Patents:
The Company believes that patents and other proprietary rights are
important to its business. It is the Company's policy to file patent
applications to protect its technology, inventions and improvements to
inventions that are considered important to the development of its
business. The Company currently holds 61 issued and pending patent
applications worldwide, including seven issued U.S. patents and 42 issued
foreign patents. The Company has four patents pending in the U.S. and eight
pending foreign patents. The issued U.S. patents include two material
composition patents covering the molecules contained in Esterom(R) solution
(including ENT-102) which expire in 2012 and 2013, respectively. The
Company has also filed a patent application with the United States Patent
Office along with international counterparts that describes a method for
the enrichment of the compounds covered in its composition of matter
patents. This patent application describes a method for the production of
Esterom(R) solution and its components, including ENT-102.
In August 2002, the Company filed a patent describing the manufacturing
process for ENT-102. The patent application describes the preparation of
commercial quantities of ENT-102 and other related compounds.
In December 2002, the Company filed a composition of matter patent
application for ENT-103. The patent application describes a new chemical
entity, or NCE, that is prepared by combining benzoylecgonine and 1,3
propanediol. ENT-102 is prepared synthetically by combining benzoylecgonine
and 1,2 propanediol. This is an example of Structure Activity Relationship,
or SAR, technology, which is the basis for systematically developing NCEs
with potentially different safety and efficacy profiles, as well as NCEs
for new indications. This new patent application claims composition of
matter containing ENT-103 and also provides the potential for the
development of a number of additional new chemical entities. The Company
believes its other patents also provide the framework for the discovery of
additional NCEs using SAR.
Stock-based compensation:
The Company follows the fair value method of accounting for employee stock
based compensation provided for in Statement of Financial Accounting
Standards No. 123, "Accounting for Stock-Based Compensation". Compensation
cost for stock option grants is measured as the fair value of the options
using the Black-Scholes option pricing model. Amounts recorded for options
10
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
granted to non-employees are determined in accordance with Statement of
Financial Accounting Standards No. 123 and EITF 96-18 based on the fair
value of the consideration or the fair value of the equity instruments
issued, whichever is more reliably measured. Deferred charges related to
options granted to non-employees are periodically remeasured as the
underlying options vest and are included as unearned stock compensation in
the stockholders' equity section of the balance sheet.
Loss per share:
Net loss per common share is computed using the weighted average number of
common shares outstanding. Basic and diluted net loss per common share
amounts are equivalent for the periods presented as the inclusion of common
stock equivalents in the number of shares used for the diluted computation
would be anti-dilutive. Dividends on preferred stock, consisting of 10%
cumulative dividends and deemed dividends related to the beneficial
conversion feature and mandatory redemption accretion of Series B preferred
stock, are added to net loss for the purpose of determining net loss and
net loss per share amounts applicable to common stockholders.
Segment reporting:
The Company currently operates in a single segment. In addition, financial
results are prepared and reviewed by management as a single operating
segment. The Company continually evaluates its operating activities and the
method utilized by management to evaluate such activities and will report
on a segment basis when appropriate to do so.
Recent accounting pronouncements:
In November 2002, the Financial Accounting Standards Board ("FASB") issued
FASB Interpretation No. 45 ("FIN 45"), "Guarantor's Accounting and
Disclosure Requirements for Guarantees, Including Indirect Guarantees of
Indebtedness of Others." FIN 45 requires that a liability be recorded for
the fair value of the obligation in the guarantor's balance sheet upon
issuance of a guarantee. In addition, FIN 45 requires certain disclosures
about each of the entity's guarantees. The disclosure provisions of FIN 45
are effective for annual and interim periods that end after December 15,
2002. The recognition provisions of FIN 45 are applicable prospectively to
guarantees entered after December 31, 2002. The adoption of FIN 45
effective January 1, 2003 did not have a material effect on the Company's
results of operations or financial position.
In May 2003, the FASB issued Statement of Financial Accounting Standards
No. 150, "Accounting for Certain Financial Instruments with Characteristics
of Both Liabilities and Equity" ("SFAS No. 150"). This statement
establishes standards for how an issuer classifies and measures certain
financial instruments with characteristics of both liabilities and equity.
11
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
This statement is effective for financial instruments entered into or
modified after May 31, 2003, and otherwise is effective for the first
interim period beginning after June 15, 2003, with certain exceptions. The
Company does not expect the adoption of SFAS No. 150 to have a material
effect on the Company's results of operations or financial position.
2. Litigation
----------
In February 2003, a complaint was filed in the Superior Court of the State
of California against the Company and certain of its executive officers
seeking unspecified damages and alleging that the defendants violated
federal and state securities laws. The Company believes the claims are
without merit and filed a motion for summary judgment with the court on
July 30, 2003. However, there can be no assurance that the Company will
succeed in defending or settling this action. Additionally, there can be no
assurance that the action will not have a material adverse effect on the
Company's business. As of the date of this report, we are not a party to
any other material legal proceedings.
3. Series A' preferred stock
-------------------------
In February 2003, the Company's Board of Directors approved and authorized
a Certificate of Designations of Series A' preferred stock. The Company
subsequently entered into separate agreements with each of the holders of
its Series A preferred stock, in which these stockholders agreed to
exchange each outstanding share of Series A preferred stock for one share
of Series A' preferred stock. The terms of the Series A' preferred stock
are the same as the terms of the Series A preferred stock except the
redemption provision of the Series A' preferred stock allows the Company to
redeem the Series A' preferred stock in cash, common stock or any
combination thereof and extends the redemption period to January 15, 2015.
Adding the option to redeem these preferred shares in common stock allowed
the Company to include the Series A' preferred stock in stockholders'
equity.
4. Nasdaq delisting
----------------
Effective June 26, 2003, the Company's common stock and warrants were
delisted from the Nasdaq SmallCap Market for failure to comply with the
$1.00 minimum bid price requirement. The Company's common stock and
warrants now trade on the OTC Bulletin Board under the symbols "ETOP" and
"ETOPW," respectively. Trading on the OTC Bulletin Board could result in a
less liquid market available for existing and potential investors to trade
shares of the Company's common stock and warrants and could ultimately
further depress the trading price of the Company's common stock and
warrants. In addition, the Company may have more difficulty in raising
necessary additional funds as a result of not trading on the Nasdaq
SmallCap Market.
5. Subsequent events
-----------------
On July 21, 2003, the Company announced a research agreement with a
specialty pharmaceutical company. Under the research agreement, the Company
will provide its proprietary compound, ENT-103, and the partner will create
several new formulations that will include its proprietary excipient. The
partner's excipient promotes enhanced absorption of drugs across dermal,
mucosal and ocular membranes. The new formulations will be tested by the
Company's paid researchers at Harvard Medical School, the University of
Arizona or other academic institutions as deemed appropriate. The goal of
this research agreement is to determine the feasibility of developing new
topical products with ENT-103 for commercialization.
12
ENTROPIN, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
On July 29, 2003, the Company announced that it had engaged InvestLinc
Capital Services, a full-service investment banking firm. InvestLinc will
assist the Company in identifying potential strategic relationships and
sources of additional capital to finance the Company's growth and further
development of its proprietary compound, ENT-103. InvestLinc will also help
identify potential investors and/or strategic partners for the Company,
including merger and acquisition candidates. The Company cannot guarantee
that it will be able to accomplish its financing goals, establish suitable
strategic relationships or identify suitable merger or acquisition
candidates.
13
PART I. ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
THE FOLLOWING DISCUSSION AND ANALYSIS SHOULD BE READ IN CONJUNCTION WITH THE
UNAUDITED FINANCIAL STATEMENTS AND NOTES THERETO INCLUDED IN PART I - ITEM 1 OF
THIS REPORT, AND THE AUDITED FINANCIAL STATEMENTS AND NOTES THERETO CONTAINED IN
OUR ANNUAL REPORT ON FORM 10-KSB/A FOR THE FISCAL YEAR ENDED DECEMBER 31, 2002.
The following Management's Discussion and Analysis of Financial Condition and
Results of Operations may contain forward-looking statements within the meaning
of Section 21E of the Securities Exchange Act of 1934, as amended and are
subject to the Safe Harbor provisions created by that statute. Our business and
results of operations are subject to various risks and uncertainties including,
but not limited to, those discussed under the caption "Factors That May Affect
Our Future Results and the Trading Price of Our Common Stock" included elsewhere
in this report, and in risk factors contained in our other periodic reports
filed with the Securities and Exchange Commission. Such risk factors include,
but are not limited to, our ability to raise significant additional capital; our
history of significant operating losses; the ability to successfully complete
formulation, development and preclinical studies for our sole drug candidate,
ENT-103; the time, cost and uncertainty of obtaining regulatory approvals; and
the ability to successfully commercialize products. The actual results that we
achieve may differ materially from any forward-looking statements due to such
risks and uncertainties and we undertake no obligation to update any such
forward-looking statements.
OVERVIEW
We were incorporated in California in 1984 as Entropin, Inc., or old Entropin,
and in 1998, completed an agreement and plan of merger with Vanden Capital
Group, Inc., or Vanden, to exchange all of the issued and outstanding common
shares of old Entropin for 5,220,000 shares of Vanden's common stock. As a
result, old Entropin was merged into Vanden, and Vanden then changed its name to
Entropin, Inc. For accounting purposes, the acquisition was treated as a
recapitalization of old Entropin based upon historical cost, with old Entropin
as the acquirer. In conjunction with the merger, Entropin, Inc. became a
Colorado corporation. In June 2002, we changed our state of incorporation from
Colorado to Delaware. The reincorporation received approval of the holders of a
majority of our outstanding shares. The reincorporation was accomplished by
merging with and into Entropin, Inc., a Delaware corporation and our formerly
wholly-owned subsidiary. Each share of common stock of the Colorado Corporation
was converted into one share of common stock of the Delaware Corporation. Each
share of Series A preferred stock of the Colorado Corporation was converted into
one share of Series A preferred stock of the Delaware corporation. Each share of
Series B preferred stock of the Colorado corporation was converted into one
share of Series B preferred stock of the Delaware corporation.
From our inception in August 1984, we have devoted our resources primarily to
funding our research and development efforts and conducting clinical trials on
our compounds. We have been unprofitable since inception and have had no revenue
from the sale of products, and do not expect revenue for the foreseeable future
until we have received FDA approval for one of the proprietary compounds we are
attempting to develop. We expect to continue to incur losses for the foreseeable
future through the completion of our preclinical and clinical trials and the FDA
approval process. As of June 30, 2003, our accumulated deficit was approximately
$31.3 million.
14
RESEARCH AND DEVELOPMENT
Prior to our current focus on ENT-103, we completed four preclinical animal
studies, Phase I, Phase II and Phase II/III human clinical trials for our first
compound, known as Esterom(R) solution. In January 2002, we reported that Dr.
Gary Strichartz, Ph.D., Professor of Anesthesia and Director of the Pain
Research Center at Harvard Medical School, and his team of researchers
identified the active ingredient in Esterom(R) solution, which we named ENT-102.
Results of our initial preclinical studies revealed that ENT-102 effectively
blocks nerve impulse conduction and when injected into animals may have
long-lasting properties to reduce and manage pain.
Based on these findings and the results of our Phase II/III clinical study with
Esterom(R) solution, we decided to forego further development of Esterom(R)
solution and pursue development of ENT-102. In January 2003, we announced the
discovery of a new chemical entity, ENT-103, the simplified next generation of
ENT-102. ENT-103 is a single chemical compound that exists as a single molecular
species. In contrast, ENT-102 is a single chemical compound comprised of a
mixture of four chemical species. Due to the demonstrated pain reduction
equivalency of ENT-103 and ENT-102 in preclinical studies, and the advantages of
pursuing regulatory approval with a single molecule versus a mixture of four
molecules, we decided to focus on the development of ENT-103 as a therapy for
treatment of acute pain.
In February 2003, we met with our key scientific advisors to review the progress
of the preclinical studies being performed at Harvard Medical School and the
University of Arizona. Based on our review of these preclinical studies, ENT-103
continues to perform as an active pain reliever in preclinical models for
post-incisional pain and neuropathic pain. Demonstrating preclinical
pharmacology is the essential first step in the development of a drug and the
data reviewed at this recent meeting continues to support the activity of
ENT-103 as a potential new pain therapeutic. The key scientific observations
from our review of these preclinical studies include:
o ENT-103 is effective in acute pain states;
o ENT-103 is effective against the consequences of acute
inflammatory pain;
o ENT-103 is effective against experimental neuropathic pain;
and
o ENT-103 suppresses the abnormal pain to tactile stimulation
that occurs after an incision.
The laboratory of Dr. Frank Porreca at the University of Arizona evaluated the
effects of ENT-103 in three pain models: (1) acute pain representative of
post-operative pain; (2) pain associated with acute and chronic inflammatory
pain; and (3) neuropathic pain. Our review of the results from this preclinical
research indicates that ENT-103 is an active compound that is effective in acute
pain states, acute inflammatory pain, and neuropathic pain, but did not alter
chronic inflammatory pain at the dose tested. Assuming the use of a delivery
system that will effectively get the drug to the site of action, ENT-103 appears
to be effective in the treatment of pain.
The laboratory of Dr. Gary Strichartz at Harvard Medical School reported
expanded studies of ENT-103 to treat the elevated pain, or hyperalgesia that
follows a surgical incision. Our review of these preclinical studies indicates
that ENT-103 demonstrates complete anesthesia of the skin for two hours after
injection. Post-incisional pain in animals, particularly pain that occurs from
tactile stimulation of the skin that is normally not painful, is usually
elevated for one to two weeks following an incision. Pre-incisional injections
of ENT-103 produce a decline in this pain with almost complete suppression of
the pain within 48 hours.
15
In April 2003, we announced that a panel of pain experts reviewed our
preclinical program, and found that the preclinical data continues to support
the development of ENT-103 as a potential analgesic/anesthetic, in particular
for the treatment of post-incisional pain.
RESEARCH AGREEMENT
On July 21, 2003, we announced a research agreement with a specialty
pharmaceutical company. Under the research agreement, we will provide our
proprietary compound, ENT-103, and the partner will create several new
formulations that will include its proprietary excipient. The partner's
excipient promotes enhanced absorption of drugs across dermal, mucosal and
ocular membranes. The new formulations will be tested by our paid researchers at
Harvard Medical School, the University of Arizona or other academic institutions
as deemed appropriate. The goal of this research agreement is to determine the
feasibility of developing new topical products with ENT-103 for
commercialization.
OUTSOURCING STRUCTURE
We maintain a limited management team and support structure for our company,
involving three full-time employees and two part-time employees. We contract
with various organizations and third parties to provide services and expertise
to us in areas such as research and development, preclinical research and
toxicology studies, clinical trials and regulatory approval applications,
clinical supply and manufacturing of our products, product packaging, and
enhanced drug formulation.
PLAN OF OPERATION
Based on our current operating budget, we believe our existing resources will
fund our operations for approximately the next six to nine months. We intend to
use our remaining funds to continue to cover operating costs and finance limited
development of our proprietary compound, ENT-103. We recognize our need to
obtain additional funds to support our operations. With this in mind, we have
retained the investment banking firm, InvestLinc Capital Services LLC.
InvestLinc will assist the Company in identifying potential strategic
relationships and sources of additional capital to finance the Company's growth
and further development of its proprietary compound, ENT-103. InvestLinc will
also help identify potential investors and/or strategic partners for the
Company, including merger and acquisition candidates. We cannot guarantee that
we will be able to accomplish our financing goals, establish suitable strategic
relationships or identify suitable merger or acquisition candidates. Moreover,
our actual expenses, obligations and liabilities may exceed those estimated in
our budget, which would significantly shorten the time in which we could
maintain our operations without obtaining additional funds.
RESULTS OF OPERATIONS
SIX MONTHS ENDED JUNE 30, 2003, COMPARED TO QUARTER ENDED JUNE 30, 2002. The net
loss for the first six months of 2003 was approximately $1,921,000, or $0.19 per
basic and diluted share on approximately 10.1 million weighted average shares
outstanding. In comparison, the net loss for the first six months of 2002 was
approximately $3.1 million, or $0.32 per share on approximately 9.9 million
weighted average shares outstanding. The net loss incurred during the first six
months of 2002 exceeded the net loss incurred during the first six months of
2003, primarily because of the costs associated with conducting our clinical
trial for Esterom(R) solution during 2002.
16
Total research and development expenses were approximately $504,000 for the
first six months of 2003, as compared to approximately $1,894,000 for the first
six months of 2002. Research and development expenses during the first six
months of 2002 exceeded expenses during the first six months of 2003, primarily
because of clinical trial expenses incurred during 2002.
Total general and administrative expenses were approximately $1,401,000 for the
first six months of 2003, as compared to approximately $1,317,000 for the first
six months of 2002. These expenses include non-cash compensation expense
associated with stock issued and stock options granted in exchange for services
of approximately $218,000 for the first six months of 2003 and approximately
$306,000 for the first six months of 2002.
We earned interest income of approximately $16,800 during the first six months
of 2003, as compared to approximately $108,000 during the first six months of
2002. This decrease reflects lower balances and declining interest rates for
cash, cash equivalents and short-term investments during 2003.
LIQUIDITY AND CAPITAL RESOURCES
We have financed our operations since inception primarily through the net
proceeds generated from the sale of our common and preferred stock, and through
loans and advances from stockholders that were subsequently converted into
equity securities. From inception through June 30, 2003, we have received net
cash proceeds from financing activities aggregating approximately $20.3 million.
As of June 30, 2003, our working capital was approximately $2.2 million.
Our liquidity and capital needs relate primarily to working capital, research
and development of ENT-103, and other general corporate requirements. We have
not received any cash from operations since inception. Based on our current
plans, we believe that our available resources will provide sufficient capital
resources for approximately the next six to nine months. Expectations about our
liquidity may prove inaccurate if development progress for our proprietary
compounds is delayed, or if our expenses are greater than currently anticipated.
We will not generate revenue from sales of any products in the foreseeable
future.
As of June 30, 2003, 128,500 shares of Series B preferred stock remained
outstanding. On July 15, 2003, all outstanding shares of our Series B preferred
stock were subject to redemption at the original purchase price of $5.00 per
share, along with all accrued and unpaid dividends. On July 18, 2003, the Board
of Directors resolved to pay the final annual dividend with stock and authorized
the issuance of 12,850 shares of the Company's common stock as payment for the
final dividend. On July 30, 2003, the Company sent each holder of Series B
preferred stock a recapitalization agreement, under which the Company agreed to
exchange each outstanding share of Series B preferred stock for 9.4967 shares of
its common stock rather than redeeming the Series B preferred stock for cash. As
of August 11, 2003, the holders of all outstanding shares of Series B preferred
stock had agreed to exchange their shares of Series B preferred stock for common
stock pursuant to a recapitalization agreement with the Company. As a result,
there are no longer any shares of Series B preferred stock outstanding as of
August 11, 2003, and the Company's redemption obligation to the prior holders of
Series B preferred stock has terminated.
Net cash used in operating activities was approximately $1.7 million during the
first six months of 2003, compared with approximately $2.7 million during the
first six months of 2002. The cash used in operations was primarily related to
funding clinical trials, expanding research and development activities and
maintaining our administrative infrastructure.
17
As of June 30, 2003, our principal source of liquidity was approximately $2.2
million in cash.
We believe that our operating expenses will remain relatively low until we
complete our preclinical research and will increase as we proceed with clinical
trials, the new drug application, or NDA, process and other activities related
to the FDA approval process. The estimated period for which we expect available
sources of cash to be sufficient to meet our funding needs is a forward-looking
statement that involves risks and uncertainties. We will need to raise
additional capital to fund future clinical trials and continue other research
and development activities. Our future liquidity and capital funding
requirements will depend on numerous factors, including the success or failure
of our preclinical research and studies on ENT-103, the timing of future
clinical trials and other activities related to the FDA approval process, the
decision of the holders of Series B preferred stock to exchange their
outstanding shares into shares of our common stock, the cost and timing of
sales, marketing and manufacturing activities, the extent to which our products,
if any, gain market acceptance, and the impact of competitors' products. There
can be no assurance that such additional capital will be available on terms
acceptable to us, if at all. If adequate funds are not available, we may be
forced to significantly curtail our operations or to obtain funds through
entering into collaborative agreements or other arrangements that may be on
unfavorable terms. Our failure to raise sufficient additional funds on favorable
terms, or at all, would have a material adverse effect on our business, results
of operations and financial position.
Effective June 26, 2003, our common stock and warrants were delisted from the
Nasdaq SmallCap Market for failure to comply with the $1.00 minimum bid price
requirement. Our common stock and warrants now trade on the OTC Bulletin Board
under the symbols "ETOP" and "ETOPW," respectively. Trading on the OTC Bulletin
Board could result in a less liquid market available for existing and potential
investors to trade shares of our common stock and warrants and could ultimately
further depress the trading price of our common stock and warrants. In addition,
we may have more difficulty in raising necessary additional funds as a result of
not trading on the Nasdaq SmallCap Market.
CRITICAL ACCOUNTING POLICIES
We routinely grant stock options to compensate officers, directors and employees
for their services. This practice allows us to conserve our cash resources for
our drug development program. We have adopted the fair value accounting
provisions of Statement of Financial Accounting Standards No. 123, "Accounting
for Stock-Based Compensation". Under these provisions, stock based compensation
is measured based on the fair value of the options granted using the
Black-Scholes option pricing model. Amounts recorded for options granted to
non-employees are determined in accordance with Statement of Financial
Accounting Standards No. 123 and EITF 96-18 based on the fair value of the
consideration or the fair value of the equity instruments issued, whichever is
more reliably measured. Deferred charges related to options granted to
non-employees are periodically remeasured as the underlying options vest and are
included as unearned stock compensation in the stockholders' equity section of
the balance sheet.
RECENT ACCOUNTING PRONOUNCEMENTS
In November 2002, the Financial Accounting Standards Board ("FASB") issued FASB
Interpretation No. 45 ("FIN 45"), "Guarantor's Accounting and Disclosure
Requirements for Guarantees, Including Indirect Guarantees of Indebtedness of
Others". FIN 45 requires that a liability be recorded in the guarantor's balance
sheet upon issuance of a guarantee. In addition, FIN 45 requires certain
disclosures about each of the entity's guarantees. The disclosure provisions of
18
FIN 45 are effective for annual and interim periods that end after December 15,
2002. The recognition provisions of FIN 45 are applicable prospectively to
guarantees entered after December 31, 2002. The adoption of FIN 45 effective
January 1, 2003 did not have a material effect on our results of operations or
financial position.
In May 2003, the FASB issued Statement of Financial Accounting Standards No.
150, "Accounting for Certain Financial Instruments with Characteristics of Both
Liabilities and Equity" ("SFAS No. 150"). This statement establishes standards
for how an issuer classifies and measures certain financial instruments with
characteristics of both liabilities and equity. This statement is effective for
financial instruments entered into or modified after May 31, 2003, and otherwise
is effective for the first interim period beginning after June 15, 2003, with
certain exceptions. The Company does not expect the adoption of SFAS No. 150 to
have a material effect on the Company's results of operations or financial
position.
FACTORS THAT MAY AFFECT OUR FUTURE RESULTS AND THE TRADING PRICE OF OUR COMMON
STOCK
ANY INVESTMENT IN SHARES OF OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU
SHOULD CONSIDER CAREFULLY THE FOLLOWING INFORMATION ABOUT THESE RISKS, TOGETHER
WITH OTHER INFORMATION CONTAINED IN THIS REPORT AND OUR OTHER FILINGS WITH THE
SECURITIES AND EXCHANGE COMMISSION BEFORE YOU DECIDE TO BUY OUR STOCK. IF ANY OF
THE FOLLOWING RISKS ACTUALLY OCCUR, OUR BUSINESS, FINANCIAL CONDITION AND
PROSPECTS WOULD LIKELY SUFFER. ADDITIONAL RISK AND UNCERTAINTIES NOT PRESENTLY
KNOWN TO US OR THAT WE CURRENTLY DEEM IMMATERIAL MAY ALSO IMPAIR OUR OPERATIONS.
WE NEED ADDITIONAL FUNDS TO SUPPORT OUR OPERATIONS. IF WE ARE UNABLE TO OBTAIN
THEM, WE WILL BE UNABLE TO COMPLETE OUR PRODUCT DEVELOPMENT AND WILL NEED TO
REDUCE OR CEASE OUR OPERATIONS.
Our independent accountants' opinion on our 2002 financial statements includes
an explanatory paragraph indicating substantial doubt, on the basis described in
that paragraph, about our ability to continue as a going concern. We currently
are able generally to pay our debts and meet our obligations as they become due,
and we believe that our existing capital resources will be sufficient to satisfy
our current and projected funding requirements for approximately the next six to
nine months. Nevertheless, to continue long-term as a going concern, we need to
raise additional funds to support our operations. Our future capital
requirements will depend on many factors, including:
o progress with preclinical studies and toxicology studies;
o the costs and expenses associated with defending against the
securities lawsuit recently filed against the Company and
certain of its executive officers;
o the time and costs involved in obtaining regulatory approvals
for our products;
o the magnitude of our research and development programs;
o the costs involved in obtaining, enforcing and defending
patent and other intellectual property rights; and
o the cost of manufacturing and of commercialization activities
and arrangements.
We intend to seek additional funding to support our future operations through
public or private sales of our equity or debt securities. Any additional equity
or debt financings would be dilutive to our stockholders. We also intend to seek
additional funding through potential corporate partnerships, licensing
arrangements and/or merger/acquisition transactions. Any such collaborative
arrangements, if necessary to raise additional funds, may require us to
19
relinquish rights to some of our technologies or products, and be dilutive to
our stockholders. We cannot guarantee that we will be able to secure additional
funds on reasonable terms, or at all. If we are unable to obtain additional
funds to support our operations, we will be unable to complete our product
development and will need to reduce or cease our operations.
WE WERE RECENTLY DELISTED FROM THE NASDAQ SMALLCAP MARKET.
Effective June 26, 2003, our common stock and warrants were delisted from the
Nasdaq SmallCap Market for failure to comply with the $1.00 minimum bid price
requirement. Our common stock and warrants now trade on the OTC Bulletin Board
under the symbols "ETOP" and "ETOPW," respectively. Trading on the OTC Bulletin
Board could result in a less liquid market available for existing and potential
investors to trade shares of our common stock and warrants and could ultimately
further depress the trading price of our common stock and warrants. In addition,
we may have more difficulty in raising necessary additional funds as a result of
not trading on the Nasdaq SmallCap Market.
In addition, the SEC has adopted regulations which generally define "penny
stock" to be any listed, trading equity security that has a market price less
than $2.50 per share or an exercise price of less than $2.50 per share, subject
to certain exemptions. These requirements may restrict the ability of
broker-dealers to sell our common stock.
WE HAVE A HISTORY OF LOSSES AND WE MAY NEVER ACHIEVE OR MAINTAIN PROFITABILITY.
To date we have experienced significant operating losses in funding the
research, development and testing of our previous drug candidate, Esterom(R)
solution, and our subsequent and current drug candidates, ENT-102 and ENT-103.
We expect to continue to incur substantial operating losses during our research,
development and preclinical testing of ENT-103 and during the regulatory
approval process for ENT-103, including the New Drug Application and clinical
trials. From our inception through June 30, 2003, we have incurred cumulative
net operating losses of $31.3 million. We will not even be able to pursue
generating revenues from sales of ENT-103 unless it is approved by the FDA for
marketing. FDA approval will take several years, if ENT-103 is approved at all.
In addition, we will need to raise substantial additional capital to pursue the
regulatory approval of ENT-103. As a result, we may never achieve a profitable
level of operations, or even if we achieve profitability, we may not be able to
sustain it on an ongoing basis.
NEGATIVE OR INCONCLUSIVE RESULTS GENERATED BY OUR ONGOING PRECLINICAL STUDIES OF
ENT-103 WILL HAVE A MATERIAL ADVERSE EFFECT ON OUR OPERATIONS AND PROSPECTS.
To date, we have completed limited preclinical studies on our sole drug
candidate, ENT-103. We are currently in the process of conducting additional
preclinical and toxicology studies that will be important in determining whether
ENT-103 remains a viable drug candidate. No assurances can be given as to the
results of or the time to complete these preclinical studies. ENT-103 may be
found to be ineffective or cause harmful side effects during pre-clinical
testing. In addition, interim results do not necessary predict final results.
Negative or inconclusive results generated during these preclinical or
toxicology studies, or any future clinical studies, will have an immediate
material adverse effect on our operations and future prospects. In addition, any
delay in the timing of the preclinical studies will adversely affect our ability
to meet certain milestones with our limited remaining funds. Further, any
negative results or delay in the preclinical studies will adversely affect our
ability to raise additional funds through the issuance of securities or
consummation of corporate partnering relationships.
20
IF WE FAIL TO OBTAIN REGULATORY APPROVAL TO COMMERCIALLY MANUFACTURE OR SELL
ENT-103, OR IF APPROVAL IS DELAYED, IT WILL INCREASE THE COST OF DEVELOPMENT,
AND WILL LIKELY PREVENT OR DELAY OUR ABILITY TO SELL ENT-103 AND GENERATE
REVENUE.
Our only current drug candidate, ENT-103, is in the preclinical development
stage and we do not anticipate beginning human clinical trials with ENT-103
until 2004. We have not yet filed an IND with FDA or requested or received
regulatory approval from the FDA for marketing products containing ENT-103.
Neither ENT-103 nor any other products that may result from our research and
development programs are expected to be commercially available for several
years, if at all.
The development of new pharmaceutical products is highly uncertain and subject
to a number of risks. The FDA approval process generally takes years and
consumes substantial capital resources with no assurance of ultimate success. We
cannot apply for FDA approval to market ENT-103 until the product successfully
completes all of the required clinical trials. Several factors may prevent our
successful completion of the clinical trials, including negative or inconclusive
preclinical results, failure or delays in the FDA approval process, insufficient
capital resources, inability to properly design and complete clinical trials or
insufficient proof that ENT-103 is safe and effective.
There can be no assurance that development of ENT-103 will be completed
successfully, that we will not encounter problems in preclinical studies or
clinical trials that will cause the delay or suspension of such trials, that
current or future testing will show ENT-103 to be efficacious or that ENT-103
will receive regulatory approval. Moreover, even if ENT-103 does receive
regulatory approval, there can be no assurance that ENT-103 will be commercially
successful, or have all of the patent and other regulatory protections necessary
to prevent competitors from producing similar products. The failure of ENT-103
to receive timely regulatory approval and achieve commercial success will have a
material adverse effect on our business and results of operations. In addition,
as a controlled substance, ENT-103 will be subject to expensive and burdensome
administrative requirements which will increase our costs.
WE RELY ON THIRD PARTIES TO TEST, RESEARCH, DEVELOP AND MANUFACTURE ENT-103 AND
THOSE THIRD PARTIES MAY NOT PERFORM SUCCESSFULLY, WHICH COULD HARM OUR BUSINESS,
FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
We depend on contractual arrangements with third parties for the provision of
services and expertise in selected areas. Under these contractual arrangements,
third parties are responsible for:
o conducting preclinical research and toxicology studies,
o conducting clinical trials and obtaining regulatory approvals,
o process and analytical methods development,
o clinical supply and commercial manufacturing,
o product packaging,
o research, and
o enhanced drug formulation(s).
Our existing contractual relationships place substantial responsibility on these
third parties, which could result in delays or termination if such parties fail
to perform as predicted. We may not be able to maintain these existing
relationships, or establish new ones on favorable terms, if at all. If these
third parties fail to perform their contractual obligations, it could have a
material adverse effect on our business and results of operations.
21
WE ARE EXPOSED TO VARIOUS LEGAL PROCEEDINGS, WHICH IF DETERMINED ADVERSELY,
COULD NEGATIVELY AFFECT OUR BUSINESS AND RESULTS OF OPERATIONS.
In February 2003, a complaint was filed in the Superior Court of the State of
California against the Company and certain of its executive officers seeking
unspecified damages and alleging that the defendants violated federal and state
securities laws. The Company believes the claims are without merit and filed a
motion for summary judgment with the court on July 30, 2003. However, there can
be no assurance that the Company will succeed in defending or settling this
action. In addition, the Company will incur legal and other fees to defend
against this action and its management team may be distracted or need to devote
significant time to this matter. As a result, there can be no assurance that the
action will not have a material adverse effect on the Company's business.
WE ARE DEPENDENT ON CONTRACT MANUFACTURERS FOR THE PRODUCTION OF ENT-103 AND OUR
FAILURE TO OBTAIN OR RETAIN THESE CONTRACT MANUFACTURERS WOULD HAVE A MATERIAL
ADVERSE AFFECT ON OUR BUSINESS AND RESULTS OF OPERATIONS.
We have, and currently plan to continue to utilize, third party manufacturing
for the production of material for use in our research and clinical trials and
for the potential commercialization of ENT-103 and any future products we may
develop. We have no experience in manufacturing and do not have any
manufacturing facilities. Consequently, we are solely dependent on contract
manufacturers for all production of ENT-103 for development and
commercialization purposes. In the event that we are unable to obtain or retain
third-party manufacturing, we will not be able to manufacture ENT-103 as
planned.
IF WE ARE UNABLE TO DEFEND OUR PATENTS AND PROPRIETARY RIGHTS, OR IF OTHERS
DEVELOP SUBSTANTIALLY EQUIVALENT PRODUCTS, OUR BUSINESS WOULD BE IMPACTED.
Our patent, trademarks and other intellectual property rights are important to
our success. Others may challenge, seek to invalidate, infringe or circumvent
any patents we own, and rights we receive under those patents may not provide
competitive advantages to us. In addition, the manufacture, use or sale of our
products may infringe on the patent rights of others. Patent litigation can be
extremely expensive and time consuming. If we are unable to defend our existing
patents or if others develop similar products beyond the protection of our
existing patents, our business could be impaired.
We may also need to initiate litigation, which could be time-consuming and
expensive, to enforce our proprietary rights or to determine the scope and
validity of others' rights. Litigation, even if wholly without merit, could
result in substantial costs and diversion of resources, regardless of the
outcome. In addition, a court may find our patents invalid or may find that we
have infringed on a competitor's rights. If any claims or actions are asserted
against us, we may be required to participate in expensive interference
proceedings to determine who has the right to a patent for the technology.
WE MAY BE EXPOSED TO PRODUCT LIABILITY CLAIMS WHICH COULD ADVERSELY AFFECT OUR
BUSINESS AND FINANCIAL CONDITION.
The clinical testing of products containing ENT-103 entails risk of product
liability claims. Medical testing has historically been litigious and we face
financial exposure to product liability claims in the event that use of our
products results in personal injury. We also face the possibility that defects
in the manufacture of ENT-103 based products might necessitate a product recall.
There can be no assurance that we will not experience losses due to product
22
liability claims or recalls in the future. We anticipate purchasing product
liability insurance in reasonable and customary amounts prior to our sale of
ENT-103 based products. Such insurance can be expensive, difficult to obtain and
may not be available in the future at reasonable cost or in sufficient amounts
to protect us against losses due to liability. An inability to maintain
insurance or to otherwise protect against potential product liability could
prevent or inhibit our commercialization of ENT-103 products. Moreover, a
product liability claim in excess of relevant insurance coverage or product
recall could have a material adverse effect on our business, financial condition
and results of operations.
WE MAY FACE INTENSE COMPETITION AND MAY NOT BE ABLE TO COMPETE EFFECTIVELY.
The pharmaceutical industry is characterized by intense competition and is
subject to rapid and significant technological change. Rapid technological
development may cause ENT-103 and any other products we develop to become
obsolete before we can recoup all or any portion of our development expenses.
Our competitors include major pharmaceutical companies, biotechnology firms,
universities and other research institutions, both in the United States and
abroad, which are actively engaged in research and development of products in
the therapeutic areas being pursued by us. Most of our competitors have
substantially greater financial, technical, manufacturing, marketing and human
resource capabilities than us. In addition, many of our competitors have
significantly greater experience in testing new or improved therapeutic products
and obtaining regulatory approval of products. Accordingly, our competitors may
succeed in obtaining regulatory approval for their products more rapidly than we
are able to obtain approval for ENT-103. If we commence significant commercial
sales of our products, we will also be competing with respect to manufacturing
efficiencies and marketing capabilities, areas in which we have no prior
experience.
WE DEPEND ON KEY PERSONNEL WHO WOULD BE DIFFICULT TO REPLACE AND OUR BUSINESS
WILL LIKELY BE HARMED IF WE LOSE THEIR SERVICES.
Our future operating results depend in significant part on the continued
contributions of our management personnel, who would be difficult to replace. In
addition, we rely on the current members of our Scientific and Advisory Board
and a significant number of consultants to assist in formulating our research
and development strategy. The loss of any these people could impede the
achievement of our objectives and our business would likely be harmed.
OUR STOCK PRICE HAS BEEN VOLATILE AND MAY CONTINUE TO EXPERIENCE SIGNIFICANT
PRICE FLUCTUATIONS.
The market prices and trading volumes for our securities, and the securities of
development stage companies in general, have historically been highly volatile
and have experienced significant price and volume fluctuations that are
unrelated to operating performance. The following factors may have an adverse
effect on the price of our securities:
o announcements of the results of research or development by us
or by our competitors,
o preclinical and/or clinical trial results,
o our failure to receive regulatory approval,
o government regulation of our industry,
o developments concerning patents or other proprietary rights,
o sales of substantial amounts of our common stock by existing
stockholders,
o comments by securities analysts, and
o general conditions in our market, the stock market, or in the
economy; and
o comments by securities analysts and market conditions in
general.
23
The market price of our common stock may continue to experience significant
fluctuations in the future, including fluctuations that are unrelated to our
performance.
FUTURE SALES OF OUR SECURITIES IN THE PUBLIC OR PRIVATE MARKET COULD LOWER OUR
STOCK PRICE AND IMPAIR OUR ABILITY IN NEW STOCK OFFERINGS TO RAISE FUNDS TO
CONTINUE OPERATIONS.
Future sales of our common stock, including shares issued upon the exercise of
outstanding options and warrants or other derivative transactions with respect
to our stock, could have a significant negative effect on the market price of
our common stock. In addition, our Certificate of Incorporation, as amended,
authorizes the issuance of up to 50,000,000 shares of common stock and up to
20,000,000 shares of preferred stock. We may seek to raise additional capital to
meet our financial needs at any time and from time to time as our Board of
Directors deems necessary and in our best interests, through the sale of equity
or other securities. Our Board of Directors has the power to issue substantial
additional shares of common stock and preferred stock without stockholder
approval. These sales may also make it more difficult for us to sell equity
securities or equity-related securities in the future at a time and price that
we would deem appropriate. If we issue any additional shares of common stock or
preferred stock, such issuance will reduce the proportionate ownership and
voting power of each other stockholder. Further, any new issuance of shares may
result in a change of control of the Company or our management.
24
ITEM 3.
CONTROLS AND PROCEDURES
(a) EVALUATION OF CONTROLS AND PROCEDURES
Within 90 days before the filing of this report, our President and Chief
Executive Officer, Dr. Thomas G. Tachovsky, and our Chief Financial Officer,
Patricia G. Kriss, carried out an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures. Based on that
evaluation, Dr. Tachovsky and Ms. Kriss concluded that our disclosure controls
and procedures are effective in causing material information to be collected,
communicated and analyzed by management of the Company on a timely basis and to
ensure that the quality and timeliness of our public disclosures comply with SEC
disclosure obligations.
(b) CHANGES IN INTERNAL CONTROLS
There were no significant changes in our internal controls or in other factors
that could significantly affect these controls after the date of our most recent
evaluation.
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PART II.
OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS.
In February 2003, a complaint was filed in the Superior Court of the State of
California against the Company and certain of its executive officers seeking
unspecified damages and alleging that the defendants violated federal and state
securities laws. The Company believes the claims are without merit and filed a
motion for summary judgment on July 30, 2003. However, there can be no assurance
that the Company will succeed in defending or settling this action.
Additionally, there can be no assurance that the action will not have a material
adverse effect on the Company's business. As of the date of this report, we are
not a party to any other material legal proceedings.
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS.
RECENT SALES OF UNREGISTERED SECURITIES
During the quarterly period ended June 30, 2003, we issued the following
unregistered securities:
In April 2003, the Company issued of 225,000 shares of restricted common stock
to an investor relations organization in exchange for services provided.
In April 2003, the Company issued of 6,000 shares of restricted common stock to
an investor relations organization in exchange for services provided.
In June 2003, the holder of 5,000 shares of Series B preferred stock converted
these shares into 5,000 shares of our common stock. The issuance of the shares
of common stock upon the conversion is exempt from registration in that there
was no sale of the shares by the Company.
USE OF PROCEEDS
Pursuant to a registration statement on Form SB-2 (File No. 333-11308) which
became effective on March 14, 2000, we sold for an aggregate market price of
$14,500,000 on March 20, 2000, 2,000,000 shares of common stock at $7.00 per
share, and 2,000,000 warrants to purchase 2,000,000 shares of common stock at
$0.25 per warrant. All offering expenses, including underwriting discounts and
commissions, finders' fees, and other underwriting expenses, totaled
approximately $2,000,000. After deduction of offering expenses, we obtained net
proceeds of approximately $12.5 million. On May 1, 2000, the managing
underwriter exercised its over-allotment option, for an aggregate price of
$1,335,000, to purchase an additional 180,000 shares of common stock at $7.00
per share, and an additional 300,000 warrants to purchase 300,000 shares of
common stock at $0.25 per warrant. After deduction of overallotment expenses of
approximately $135,000, we obtained net proceeds of approximately $1.2 million.
To date the net proceeds we received from our secondary offering and
over-allotment have been used as follows: approximately $3.7 million for general
and administrative expenses and working capital; approximately $7.1 million for
clinical trials and associated research and development expenses; approximately
$480,000 for research associated with reformulation and understanding
Esterom(R)'s mechanism of action; and approximately $1.4 million for activities
related to the preparation of our NDA. We have used a total of approximately
$12.7 million of the secondary offering and over allotment proceeds. The
remaining proceeds, plus interest earned on these funds, total approximately
26
$2.0 million and are held in cash and money market funds. As part of general and
administrative expenses, our directors have received cash payments of
approximately $136,500 for their services; our officers have received
approximately $712,000 for their services; and Thomas Anderson, who owns more
than 10% of our common stock, indirectly received $31,000 in the form of rent
for our office space which was paid to the Law Offices of Thomas Anderson.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
NONE.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
There have been no matters submitted to a vote of security holders during the
quarterly period ended June 30, 2003 through the solicitation of proxies or
otherwise.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits
EXHIBIT NO. DESCRIPTION
----------- -----------
2.1 Agreement and Plan of Merger, dated May 2, 2002, by and
between Entropin, Inc., a Delaware corporation, and Entropin,
Inc., a Colorado corporation.(1)
3.1 Certificate of Incorporation of Entropin, Inc., a Delaware
corporation.(2)
3.2 Bylaws of Entropin, Inc., a Delaware corporation.(2)
3.3 Certificate of Designations of Series A' Preferred Stock of
Entropin, Inc.(3)
31.1 Certification of Principal Executive Officer under Section 302
of the Sarbanes-Oxley Act of 2002.
31.2 Certification of Chief Financial Officer under Section 302 of
the Sarbanes-Oxley Act of 2002.
32.1 Certification of Principal Executive Officer under Section 906
of the Sarbanes-Oxley Act of 2002.
32.2 Certification of Chief Financial Officer under Section 906 of
the Sarbanes-Oxley Act of 2002.
27
(1) Incorporated by reference from the like numbered exhibit as filed
with the Company's quarterly report on Form 10-QSB on August 14, 2002.
(2) Incorporated by reference from the like numbered exhibits as filed
with the Company's quarterly report on Form 8-K on June 26, 2002.
(3) Incorporated by reference from the like numbered exhibit as filed
with the Company's annual report on Form 10-KSB/A on April 30, 2003.
(b) Reports on Form 8-K
-------------------
During the current quarter and prior to filing this Report, we filed the
following Current Reports on Form 8-K:
On April 30, 2003, we filed a Form 8-K attaching a press release in which we
announced the receipt of a Nasdaq Staff Determination indicating that our common
stock was subject to delisting from The Nasdaq SmallCap Market for failure to
comply with Nasdaq's $1.00 minimum bid price requirement (Marketplace Rule
4310(c)(4)).
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SIGNATURES
In accordance with the requirements of the Exchange Act, the Company caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized.
ENTROPIN, INC., a Delaware corporation
Date: August 12, 2003 By: /s/ Thomas G. Tachovsky, Ph.D.
--------------------------------------
Thomas G. Tachovsky, Ph.D.
President and Chief Executive Officer
Date: August 12, 2003 By: /s/ Patricia G. Kriss
--------------------------------------
Patricia G. Kriss
Chief Financial Officer
29