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, 1999
or
|_| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from _____________ to ___________
Commission file number 000-26422
DISCOVERY LABORATORIES, INC.
(Exact name of small business issuer as specified in its charter)
Delaware 94-3171943
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
350 South Main Street, Suite 307
Doylestown, Pennsylvania 18901
(Address of principal executive offices) (Zip Code)
Registrants' telephone number, including area code: (215) 340-4699
Securities registered under Section 12 (b) of the Exchange Act: None
Securities registered under Section 12 (g) of the Exchange Act:
Common Stock, par value $.001 per share
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. |X| Yes |_| No
As of August 13, 1999, 9,064,889 shares of Common Stock, par value $.001 per
share, were outstanding.
Documents incorporated by reference: None.
Transitional Small Business Disclosure Format: |_| Yes |X| No
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DISCOVERY LABORATORIES, INC.
Table of Contents
Page
----
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements (unaudited)
CONSOLIDATED BALANCE SHEETS --
As of June 30, 1999 (unaudited) and December 31, 1998 ... Page 3
CONSOLIDATED STATEMENTS OF OPERATIONS --
For the Three and Six Months Ended June 30, 1999
(unaudited) and June 30, 1998; and for the Period
from May 18, 1993 (Inception) through June 30, 1999
(unaudited) ............................................. Page 4
CONSOLIDATED STATEMENTS OF CASH FLOWS --
For the Six Months Ended June 30, 1999 (unaudited) and
June 30, 1998 and for the Period from May 18, 1993
(Inception) through June 30, 1999 (unaudited) ........... Page 5
Notes to Financial Statements .............................. Page 6
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations ......................... Page 7
PART II - OTHER INFORMATION
Item 1. Legal Proceedings. .......................................... Page 11
Item 2. Change in Securities. ....................................... Page 11
Item 3. Defaults Upon Senior Securities. ............................ Page 11
Item 4. Submission of Matters to a Vote of Security Holders. ........ Page 12
Item 5. Other Information. .......................................... Page 12
Item 6. Exhibits and Reports on Form 8-K. ........................... Page 12
Signatures ........................................................... Page 13
Page 2
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DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)
Consolidated Balance Sheets
(Unaudited)
<TABLE>
<CAPTION>
June 30, December 31,
1999 1998
---- ----
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 729,000 $ 1,474,000
Marketable Securities 1,467,000 2,544,000
Stock Subscriptions and other receivables 7,000
Inventory (Note 1) 575,000 575,000
Prepaid expenses 62,000 203,000
----------------- ----------------
Total current assets 2,840,000 4,796,000
Property and equipment, net of deprecation 320,000 326,000
Security deposits 18,000 18,000
----------------- ----------------
$ 3,178,000 $ 5,140,000
================= ================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 1,088,000 $ 1,088,000
----------------- ----------------
Commitments
Stockholders' Equity:
Preferred stock, $.001 par value; 5,000,000 shares authorized: Series B
convertible; 1,617,505 and 1,946,881 shares issued and outstanding at June
30, 1999 and December 31, 1998, respectively (liquidation preference
$21,836,000 at June 30, 1999) 2,000 2,000
Series C redeemable convertible; 2,039 shares issued and outstanding
(liquidation preference $2,328,000) 2,379,000 2,277,000
Common stock, $.001 par value; 20,000,000 authorized; 6,743,218 and 5,085,281
shares issued and outstanding at June 30, 1999 and December 31, 1998
respectively 7,000 5,000
Treasury stock (at cost 2,000 and 15,600 shares of common stock at June 30, 1999
and December 31, 1998, respectively) (5,000) (39,000)
Additional paid-in capital 30,917,000 29,842,000
Unearned portion of compensatory stock options (37,000) (124,000)
Deficit accumulated during the development stage (Note 1) (31,753,000) (27,930,000)
Prior period adjustment 575,000
Accumulated other comprehensive income: unrealized gain on marketable
securities available for sale 5,000 19,000
----------------- ----------------
Total stockholders' equity 2,090,000 4,052,000
----------------- ----------------
$ 3,178,000 $ 5,140,000
================= ================
</TABLE>
See notes to financial statements Page 3
<PAGE>
DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)
Consolidated Statements of Operations
(Unaudited)
<TABLE>
<CAPTION>
May 18, 1993
(Inception)
Three Months Ended Six Months Ended Through
June 30, June 30, June 30,
---------------------------- ---------------------------- ------------
1999 1998 1999 1998 1999
------------ ------------ ------------ ------------ ------------
<S> <C> <C> <C> <C> <C>
Interest income $ 30,000 102,000 $ 67,000 226,000 $ 1,379,000
------------ ------------ ------------ ------------ ------------
Expenses:
Write-off of acquired in-process
research and development and
supplies 8,230,000 8,230,000 13,508,000
Research and development 472,000 1,648,000 1,891,000 3,357,000 11,864,000
General and administrative 686,000 775,000 1,322,000 1,422,000 6,656,000
Interest 11,000
------------ ------------ ------------ ------------ ------------
Total expenses 1,158,000 10,653,000 3,213,000 13,009,000 32,039,000
------------ ------------ ------------ ------------ ------------
(1,128,000) (10,551,000) (3,146,000) (12,783,000) (30,660,000)
Minority interest in net loss of
subsidiary 0 24,000 26,000
------------ ------------ ------------ ------------ ------------
Net loss (1,128,000) (10,551,000) (3,146,000) (12,759,000) (30,634,000)
Other comprehensive income:
Unrealized gain on marketable
securities available for sale (2,000) 0 (5,000) 0 14,000
------------ ------------ ------------ ------------ ------------
Total comprehensive loss $ (1,130,000) (10,551,000) $ (3,151,000) (12,759,000) $(30,620,000)
============ ============ ============ ============ ============
Net loss per share - basic and diluted $ (0.18) $ (3.14) $ (0.51) $ (3.90)
============ ============ ============ ============
Weighted average number of common
shares outstanding 6,597,000 3,361,000 6,121,000 3,275,000
============ ============ ============ ============
</TABLE>
See notes to financial statements Page 4
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DISCOVERY LABORATORIES, INC. AND SUBSIDIARY
(a development stage company)
Consolidated Statements of Cash Flows
(Unaudited)
<TABLE>
<CAPTION>
May 18, 1993
Six Months Ended (Inception)
June 30, Through
---------------------------- June 30,
1999 1998 1999
------------ ------------ ------------
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss $ (3,146,000) $(12,759,000) $(30,634,000)
Adjustments to reconcile net loss to net cash used in
operating activities:
Write-off of acquired in-process research and
development and supplies 8,230,000 13,508,000
Write-off of licenses 683,000
Depreciation and amortization 39,000 17,000 168,000
Compensatory stock options 124,000 142,000
Changes in:
Prepaid expenses and other current assets 135,000 90,000 (37,000)
Accounts payable and accrued expenses 69,000 321,000 951,000
Other assets (18,000)
Expenses paid on behalf of company 18,000
Expenses paid using treasury stock 51,000
Employee stock compensation 42,000
Reduction of research and development supplies (161,000)
------------ ------------ ------------
Net cash used in operating activities (2,780,000) (4,101,000) (15,287,000)
------------ ------------ ------------
Cash flows from investing activities:
Acquisition of furniture and equipment (33,000) (19,000) (465,000)
Proceeds from disposal of furniture and equipment 25,000 25,000
Acquisition of licenses (711,000)
Purchase of investments (732,000) (20,745,000)
Proceeds from sale or maturity of investments 1,063,000 2,140,000 19,688,000
Net cash payments on merger (226,000) (1,670,000)
------------ ------------ ------------
Net cash provided by (used in) investing activities 1,030,000 1,188,000 (3,878,000)
------------ ------------ ------------
Cash flows from financing activities:
Proceeds on private placements of units, net of expenses 18,925,000
Purchase of treasury stock (5,000) (95,000)
Collections on stock subscriptions and proceeds on exercise of
stock options 1,009,000 0 1,064,000
------------ ------------ ------------
Net cash (used in) provided by financing activities 1,004,000 0 19,894,000
------------ ------------ ------------
Net (decrease) increase in cash and cash equivalents (745,000) (2,913,000) 729,000
Cash and cash equivalents - beginning of period 1,474,000 6,297,000
------------ ------------ ------------
Cash and cash equivalents - end of period $ 729,000 $ 3,384,000 $ 729,000
============ ============ ============
Noncash transactions:
Accrued dividends on ATI preferred stock $ 102,000 $ 102,000 $ 544,000
Accounts Payable settled using treasury stock 39,000 39,000
Common stock issued to settle payables 30,000 30,000
Preferred Stock issued for inventory 575,000
</TABLE>
See notes to financial statements Page 5
<PAGE>
NOTE 1 - THE COMPANY AND BASIS OF PRESENTATION
The Company
Discovery Laboratories, Inc. (the "Company"), formerly known as Ansan
Pharmaceuticals, Inc. ("Ansan"), was incorporated in Delaware on November 6,
1992 and was a wholly owned subsidiary of Titan Pharmaceuticals, Inc. ("Titan").
The Company was formed to license and develop pharmaceutical products to treat a
variety of human diseases. In August 1995, Ansan issued its securities in an
initial public offering and ceased to be a wholly owned subsidiary of Titan. In
November 1997, Ansan merged (the "Ansan Merger") with Discovery Laboratories,
Inc., a former Delaware corporation ("Old Discovery"), and was the surviving
corporate entity. Subsequent to the Ansan Merger, Ansan changed its name to
Discovery Laboratories, Inc. Pursuant to the Ansan Merger, each outstanding
share of Old Discovery's common stock was converted into 1.167471 shares of the
Company's common stock and each share of Old Discovery's Series A convertible
preferred stock was converted into one share of the Company's Series B preferred
stock (the "Ansan Exchange Ratios"). The Company also assumed all outstanding
options and warrants to purchase Old Discovery's common stock and Series A
preferred stock which became exercisable for the Company's common stock and
Series B preferred stock, respectively, based on the Ansan Exchange Ratios. In
connection with the Ansan Merger, the Company and Titan entered into
arrangements providing for the relinquishment by the Company of rights to
certain drug compounds and the transfer of such rights to Titan in exchange for
(i) a 2% net royalty payable by Titan to the Company from net sales of such drug
compounds and (ii) the cancellation of all Ansan common stock owned by Titan. On
consummation of the merger, 13,000 shares of Ansan Series A preferred stock held
by Old Discovery were cancelled.
The Ansan Merger was accounted for as a reverse acquisition with Old Discovery
as the acquirer for financial reporting purposes since Old Discovery's
stockholders owned approximately 92% of the merged entity on a diluted basis.
The consolidated financial statements include the accounts of Ansan from
November 25, 1997 (the date of acquisition). The assets and liabilities acquired
in the Ansan Merger were recorded at fair value on the date of the merger. The
difference between the fair value of the net assets acquired and value of the
common stock issued plus merger related costs was attributed to in-process
research and development and was recorded as an expense upon acquisition.
In June 1998, ATI Acquisition Corp., a wholly owned subsidiary of the Company,
merged with and into a then majority owned subsidiary of the Company, Acute
Therapeutics, Inc. ("ATI"), with ATI being the surviving entity (the "ATI
Merger"). Pursuant to the ATI Merger, each outstanding share of ATI's common
stock was exchanged for 3.90 shares of the Company's common stock (the "ATI
Exchange Ratio") and each share of ATI's Series B preferred stock was converted
into one share of the Company's Series C preferred stock. All outstanding
options to purchase ATI common stock were assumed by the Company and are
exercisable for shares of the Company's common stock on the basis of the ATI
Exchange Ratio. Pursuant to employment agreements entered into with the Company
in connection with the ATI Merger, ATI management was granted, in the aggregate,
options to purchase (i) 338,500 shares of the Company's common stock, subject to
vesting, and (ii) 335,000 shares of the Company common stock, subject to the
achievement of certain corporate milestones. As the options for the 335,000
shares are variable options, the Company will incur a charge at each reporting
date until the options are fully vested for the excess, if any of the market
price of the Company's common stock over the exercise price of the options. In
addition, pursuant to a management agreement entered into between the Company
and ATI at the time the merger agreement relating to the ATI Merger was
executed, the members of ATI management were granted options to purchase 126,500
shares of the Company's common stock.
The historical consolidated financial position of the Company includes the
accounts of ATI. The value of the common stock of the Company issued to ATI's
common stockholders plus the assumption of the outstanding ATI options and
merger related costs has been attributed to in-process research and development
upon managements evaluation and has been recorded as an expense upon
acquisition.
Basis of Presentation
The accompanying financial statements include the accounts of the Company and
its wholly owned subsidiary, ATI. All intercompany balances and transactions
have been eliminated.
The accompanying unaudited, consolidated, condensed financial statements have
been prepared in accordance with generally accepted accounting principles for
interim financial information in accordance with the instructions to Form
10-QSB. Accordingly, they do not include all of the information and footnotes
required by generally accepted accounting principles for complete financial
statements. In the opinion of management, all adjustments (consisting of
normally recurring accruals) considered for fair presentation have been
included. Operating results for the three-month and six-month periods ended June
30, 1999 are not necessarily indicative of the results that may be expected
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for the year ended December 31, 1999. For further information, refer to the
consolidated financial statements and footnotes thereto included in the
Company's 1998 Annual Report on form 10-KSB.
The Company's activities since incorporation have primarily consisted of
conducting research and development, performing business and financial planning
and raising capital. Accordingly, the Company is considered to be in the
development stage, and expects to incur increasing losses and require additional
financial resources to achieve commercialization of its products.
The Company also depends on third parties to conduct research on the Company's
behalf through various research agreements. All of the Company's current
products under development are subject to license agreements that will require
the payment of future royalties.
Net Loss Per Share
Net loss per share is computed based on the weighted average number of common
shares outstanding for the periods and common shares issuable for little or no
cash consideration. Common shares issuable upon the exercise of options and
warrants and the conversion of convertible securities are not included in the
calculation of the net loss per share as their effect would be antidilutive.
Correction of Error and Restatement of Previously Issued Financial Statements
In October 1996, pursuant to a licensing agreement with Johnson & Johnson,
Inc.'s ("J&J") wholly owned subsidiary Ortho Pharmaceuticals, Inc., J&J
contributed manufacturing equipment and raw material inventory in exchange for
2,039 shares (originally 2,200 shares) of the Company's non-voting Series B
preferred stock which had a liquidation preference of $ 2,039,000. The equipment
and inventory was charged to operations as acquired in-process research and
development and supplies during the year ended December 31, 1996. However,
certain of this raw material inventory, valued at approximately $ 575,000, which
was then located at the vendor and had an alternative future use in that the
inventory could be sold to other users and, was in excess of the quantity
required for the Company's research and development purposes, and thereby the
Company had arranged with the vendor to defer delivery of the product.
Previously issued financial statements have been restated to reflect
capitalizing such inventory effective December 31, 1996 and a corresponding
reduction in deficit accumulated during the development stage.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
When used in this report, the words "estimate", "project", "intend", "forecast",
"anticipate" and similar expressions are intended to identify forward-looking
statements. In addition, certain other statements set forth in this report,
including, without limitation, statements concerning the Company's research and
development programs, the possibility of submitting regulatory filings for the
Company's products under development, the seeking of joint development or
licensing arrangements with pharmaceutical companies or others, the research and
development of particular compounds and technologies for particular indications
and the period of time for which the Company's existing resources will enable
the Company to fund its operations and the possibility of contracting with other
parties additional licenses to develop, manufacture and market commercially
viable products, are forward-looking and based upon the Company's current belief
as to the outcome, occurrence and timing of future events or current
expectations and plans. All such statements involve significant risks and
uncertainties. Many important factors affect the Company's ability to achieve
the stated outcomes and to successfully develop and commercialize its product
candidates, including, among other things, the ability to obtain substantial
additional funds, obtain and maintain all necessary patents or licenses, to
demonstrate the safety and efficacy of product candidates at each state of
development, to meet applicable regulatory standards and receive required
regulatory approvals, to meet obligations and required milestones under its
license agreements, to be capable of producing drug candidates in commercial
quantities at reasonable costs, to compete successfully against other products
and to market products in a profitable manner. Although the Company believes
that its assumptions underlying the forward-looking statements are reasonable,
any of the assumptions could prove inaccurate and, therefore, there also can be
no assurance that these statements included in the report will prove to be
accurate. In light of the significant uncertainties inherent in these statements
included herein, the inclusion of such information should not be regarded as a
representation by the Company or any other person that the objectives and plans
of the Company will be achieved; in fact, actual results could differ materially
from those contemplated by such forward-looking statements. The Company does not
undertake any obligation to publicly release any revisions to these
forward-looking statements or to reflect the occurrence of unanticipated events.
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Plan of Operations
Since its inception, the Company has concentrated its efforts and resources in
the development and commercialization of pharmaceutical products and
technologies. The Company has been unprofitable since its founding and has
incurred a cumulative net loss of approximately $30,634,000 as of June 30, 1999.
The Company expects to incur significantly increasing operating losses over the
next several years, primarily due to the expansion of its research and
development programs, including clinical trials for some or all of its existing
products and technologies and other products and technologies that it may
acquire or develop. The Company's ability to achieve profitability depends upon,
among other things, its ability to discover and develop products, obtain
regulatory approval for its proposed products, and enter into agreements for
product development, manufacturing and commercialization. None of the Company's
products currently generates revenues and the Company does not expect to achieve
revenues for the foreseeable future. Moreover, there can be no assurance that
the Company will ever achieve significant revenues or profitable operations from
the sale of any of its products or technologies.
The Company is a development stage pharmaceutical company that is focused on
developing compounds intended for neonatal use in critical care hospital
settings. The Company is also developing its lead product candidate for the
treatment of acute respiratory distress syndrome and acute lung injury
("ARDS/ALI"). The Company anticipates that during the next 12 months it will
conduct substantial research and development of its compounds.
SURFAXIN(R) (lucinactant)
Meconium Aspiration Syndrome (MAS)
The Company recently finished a Phase 2 clinical trial in MAS in full-term
newborns. This 22-patient trial showed an improvement in oxygenation parameters
and a three-day savings on mechanical ventilation. Based on the results of this
trial, the Company is planning a pivotal Phase 3 trial in MAS. This trial is
expected to be a multi-centered, randomized trial versus patients on standard of
care since there are no FDA approved therapies available to treat MAS. An Orphan
Products Development Grant awarded to the Company by the FDA Office of Orphan
Products Development is expected to contribute significantly to the costs of
this trial.
Respiratory Distress Syndrome (RDS)
The Company is currently planning to commence a Phase 3 clinical trial of
Surfaxin(R) for the treatment of RDS in premature infants during 1999. Such
trial, and any other clinical trials of the Company's products in development
that have not yet commenced, will require the receipt of approvals by the United
States Food and Drug Administration (the "FDA") and/or world health authorities.
There can be no assurance as to the receipt or the timing of such approvals.
Acute Respiratory Distress Syndrome/Acute Lung Injury (ARDS/ALI)
A pivotal Phase 2/3 clinical trial of Surfaxin(R) for the treatment of ARDS/ALI
was commenced on July 14, 1998. All of the 43 clinical sites identified by the
Company for participation in the ARDS/ALI trial have completed all internal
review board and other approvals relating to the original protocol for the
trial. The protocol was recently amended and the Company is in the process of
obtaining internal review board approvals relating to the amended protocol. To
date, 14 patients have been enrolled in the ARDS/ALI trial.
SUPERVENT(TM) (tyloxapol)
Cystic Fibrosis (CF)
The Company has completed a Phase 1 trial in normal healthy volunteers and has
determined a dose (1.25%) that did not produce significant adverse effects. A
Phase 2A trial in CF patients was recently initiated where the intent is to show
inhibition of inflammatory pulmonary events in these patients.
DSC-103
On December 5, 1997 a Phase 1 clinical study of DSC-103 (formerly known as
ST-630) as a once-daily, orally administered drug for the treatment of
postmenopausal osteoporosis in the United States was initiated. Part B of such
trial was commenced on April 2, 1998 and was successfully completed on June 29,
1998. On July 30, 1999 the Company announced that it had completed a licensing
deal for DSC-103 with YuYu Industrial Company, Ltd. of Korea. The deal is the
first one completed by Discovery for DSC-103. The privately owned YuYu
Industrial, Ltd. currently markets the natural hormonal form of vitamin D,
calcitriol, in the Korean pharmaceutical market. The sublicense agreement is
royalty based and includes small upfront fees and milestones. As part of the
agreement, YuYu has agreed to an exclusive supply agreement whereby they will
purchase DSC-103 drug
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substance from Discovery. It is the Company's present intention to seek to
develop DSC-103 through a corporate partnering arrangement rather than directly.
Liquidity
The Company's working capital requirements will depend upon numerous factors,
including, without limitation, progress of the Company's research and
development programs, preclinical and clinical testing, timing and cost of
obtaining regulatory approvals, levels of resources that the Company devotes to
the development of manufacturing and marketing capabilities, technological
advances, status of competitors and the ability of the Company to establish
collaborative arrangements with other organizations. During March and April,
1999, the Company received proceeds totaling $1 million from a private equity
financing with primarily existing investors. On July 29, the Company completed a
second private placement totaling $2.45 million through a private placement of
equity. The Company will be required to raise additional capital in order to
meet its business objectives, and there can be no assurance that it will be
successful in doing so or, in general, that the Company will be able to achieve
its business objectives. The Company has eliminated certain positions and taken
other steps to reduce its use of cash pending the raising of additional equity
capital, which the Company intends to pursue during the first half of 1999. The
Company believes that such reduced use of cash will not interfere with the
achievement of the Company's major business objectives and, accordingly, that
its current resources will permit it to meet its business objectives until the
first quarter of 2000. In the event that the Company does not achieve certain
financing and/or corporate partnering objectives during the Fall of 1999, the
Company intends to further reduce its use of cash so that its cash resources
will be sufficient to continue operations into the third quarter of 2000.
Year 2000 Compliance
With the new millenium approaching, many institutions around the world are
reviewing and modifying their computer systems to ensure that they are Year 2000
compliant. The issue, in general terms, is that many existing computer systems
and microprocessors with data functions use only two digits to identify a year
in the date field with the assumption that the first two digits are always "19".
Consequently, on January 1, 2000, computers that are not Year 2000 compliant may
read the year as 1900. Systems that calculate, compare or sort using the
incorrect date may malfunction.
The Company is working to resolve the potential impact of the Year 2000 on the
ability of its computerized information systems to accurately process
date-sensitive information. The systems include database, networking and
accounting software licensed by the Company. The Company does not use equipment
with embedded chip technology that is date sensitive. Although the Company has
not yet completed its assessment of its internal operations, the Company has
been advised by the vendors of its office and networking software that the
Company will receive vendor certifications confirming that these systems are
Year 2000 compliant. The Company has previously been advised that its accounting
software package is Year 2000 compliant. If such software does not in fact prove
to be Year 2000 compliant, the Company would experience temporary administrative
disruptions but such disruptions would not threaten or materially interfere with
the Company's drug development activities.
The Company has made inquiries of suppliers and other third parties with whom it
has significant business relationships in order to determine whether such third
parties have undertaken measures to ensure that their information technology
systems will be Year 2000 compliant insofar as the Company is concerned. These
third parties include contract manufacturing facilities utilized by the Company
to produce Surfaxin(R) and SuperVentTM, contract laboratories at which stability
testing of raw drug product is performed, facilities at which the Company's
clinical trials are being undertaken and the Company's transfer agent. The
Company has confirmed Year 2000 compliant status of all contract manufacturing
and contract laboratory facilities utilized by the Company. The status of its
clinical trial sites is still under evaluation. The potential consequences of a
Year 2000 compliance failure on the part of a hospital or other facility
participating in the Company's clinical trials range from the possible need to
eliminate data points generated by specific facilities to delay in completion
and evaluation of such trials, and could also result in a need for further
dialogue with the FDA regarding clinical trial integrity if a significant
problem were to emerge.
The Company's Year 2000 project is substantially complete . Assuming that the
Company is not required to incur transfer costs as a result of any failure of
its vendors to achieve Year 2000 compliance in a timely fashion, the Company
anticipates that the cost of implementing its Year 2000 program will be limited
to out-of-pocket costs related to making inquiries of, and receiving and
reviewing confirmations from, third parties. The Company currently estimates
that such costs will not exceed $10,000.
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The Company has purchased back-up electrical generators to ensure that
temperature sensitive materials that are critical to the Company's drug
development efforts will not be harmed by any power outages at its Doylestown,
Pennsylvania facility. Although not purchased with a view toward Year
2000-related risks, these generators are available to address any interruptions
in electrical service related to Year 2000 compliance problems experienced by
local utilities. The Company has developed contingency plans to address any
other Year 2000 compliance risks that are uncovered by its continuing evaluation
efforts.
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PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 2. CHANGE IN SECURITIES.
From March 31 through April 7, 1999, the Company sold to certain investors
shares of Common Stock and a newly created class of warrants of the Company (the
"Class C Warrants") for an aggregate purchase price of $1,000,000 (the "April
Financing"). Investors in the April Financing received, for each $100,000
invested, 53,192 shares of Common Stock at a purchase price of $1.88 and 53,192
Class C Warrants, each of which was exercisable for the purchase of a share of
Common Stock for an exercise price of $2.30 at any time prior to the seventh
anniversary of the issuance of such warrant. Pursuant to price adjustment
provisions extended to investors in the April Financing, as a consequence of the
Unit Offering, described below, investors in the April Financing received an
aggregate of 294,531 additional shares of Common Stock for no additional
consideration and the per share exercise price applicable to the Class C
Warrants has been reduced from $2.30 to $2.15. The issuance of the securities
received by investors in the April Financing was deemed to be exempt from
registration under the Act in reliance on Section 4(2) thereof and Regulation D
thereunder because such issuance did not involve a public offering. Investors in
the April Financing represented their intention to acquire the securities for
investment only and not with a view to or for sale in connection with any
distribution thereof and appropriate legends were affixed to the securities
certificates issued in such transactions. The investors in the April Financing
had adequate access to information about the Company. Moreover, such investors
represented to the Company, and the Company believed, that they were experienced
in financial matters.
Investors in the April Financing will be entitled to receive additional shares
of Common Stock for no additional consideration and to have the exercise price
applicable to the Class C Warrants reduced if, within 150 days from the
effective dates of the respective purchases pursuant the April Financing, the
Company (i) shall sell shares of Common Stock in a private offering at less than
$1.21 per share, or (ii) shall sell, in a private offering, any shares of
capital stock or equity derivatives of the Company that are convertible into, or
exercisable for, shares of Common Stock at a conversion price or exercise price
less than $1.21 per share. In no event will the effective purchase price of
Common Stock sold in the April Financing be reduced below $0.86 per share,
pursuant to the foregoing adjustments.
On July 28, 1999, the Company received $2.45 million in gross proceeds when it
completed a private offering of Units (the "Unit Offering"), at a per Unit price
of $500,000, consisting of (a) a number of shares of the Company's Common Stock,
par value $0.001 per share (the "Common Stock"), equal to $500,000 divided by
$1.21, which was the average closing bid price of the Common Stock for the five
trading days immediately preceding the Closing Date (the "Closing Bid Price"),
and (b) an equal number of the Company's Class D Warrants, each of which
entitles the holder thereof to purchase a share of Common Stock at any time
prior to the close of business on July 27, 2004 at a per share purchase price
equal to 110% of the Closing Bid Price. Pursuant to a placement agency agreement
with the Company, Paramount Capital, Inc. ("Paramount"), which acted as
placement agent with respect to the Unit Offering, received $171,500 in cash
commissions and was reimbursed for certain expenses incurred by Paramount in
connection with the Unit Offering. In addition, Paramount received options (the
"Placement Options") to acquire 0.49 Units at a per Unit exercise price of
$550,000 as partial compensation for its services in connection with the Unit
Offering.
Pursuant to the terms of the subscription agreements entered into with the
investors in the Unit Offering, the Company is obligated to file by August 28,
1999 a registration statement covering the shares of Common Stock (i) included
in the Units and (ii) subject to the Class D Warrants included in the Units
(including, in each case, Units subject to the Placement Options). Pursuant to
the terms of the April Financing, investors in the April Financing are entitled
to have included in such registration statement the shares of Common Stock
received by them in such private placement (including the shares of Common Stock
subject to the Class C Warrants issued in such private placement). Certain other
holders of piggyback registration rights may elect to include shares of Common
Stock in such registration statement.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES.
None.
Page 11
<PAGE>
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
On June 28, 1999 the Company held its Annual Meeting of Stockholders (the
"Annual Meeting"). The following matters (each of which were described in
further detail in the Company's Proxy Statement on Schedule 14A relating to the
Annual Meeting) were submitted to a vote of the stockholders:
1. Election of Directors
Each of the nine nominees for the Board of Directors was elected:
For Withheld
--- --------
Robert Capetola, Ph.D. 8,722,526 27,136
Steve H. Kanzer, Esq. 8,722,526 27,136
Max Link, Ph.D. 8,687,502 62,159
Richard Power 8,687,502 62,159
Marvin Rosenthale, Ph.D. 8,722,526 27,136
Herbert McDade, Jr. 8,722,526 27,136
Mark Rogers, M.D. 8,722,526 27,136
David Naveh, Ph.D. 8,722,526 27,136
Richard Sperber 8,687,502 62,159
2. Consideration and approval of an amendment to the Company's 1998
Stock Incentive Plan (the "1998 Plan") that increases the number of
shares of Common Stock available under the 1998 Plan from 1,406,024
to 2,200,959 shares.
The stockholders approved the amendment of the Company's 1998 Stock
Incentive Plan:
<TABLE>
<CAPTION>
Affirmative Negative Broker
Votes Votes Abstentions Non-Votes
--------------------- --------------------- --------------------- ---------------------
<S> <C> <C> <C> <C>
4,841,087 97,424 7,300 3,803,851
</TABLE>
3. Consideration and approval of a proposed Stock Purchase Agreement
between the Corporation and Crescent International Limited.
The stockholders approved the proposed Stock Purchase Agreement:
<TABLE>
<CAPTION>
Affirmative Negative Broker
Votes Votes Abstentions Non-Votes
--------------------- --------------------- --------------------- ---------------------
<S> <C> <C> <C> <C>
4,881,087 46,133 17,721 3,803,851
</TABLE>
Notwithstanding stockholder approval of such Stock Purchase
Agreement, the Company has deferred entering into such Stock
Purchase Agreement.
4. Consideration and approval of an amendment to the Corporation's
Restated Certificate of Incorporation to increase the number of
authorized shares of Common Stock available for issuance by the
Corporation from 20 million to 35 million.
The stockholders approved the amendment of the Company's Restated
Certificate of Incorporation:
<TABLE>
<CAPTION>
Affirmative Negative
Votes Votes Abstentions
--------------------- --------------------- ---------------------
<S> <C> <C> <C>
8,662,727 74,352 12,583
</TABLE>
ITEM 5. OTHER INFORMATION.
None
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibits:
27.1 Financial Data Schedule.
Page 12
<PAGE>
(b) Reports on Form 8-K:
None.
Page 13
<PAGE>
SIGNATURES
In accordance with the requirements of the Exchange Act, the Registrant has
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
Discovery Laboratories, Inc.
(Registrant)
Date: August 16, 1999 /s/ Robert J. Capetola
---------------------------------
Robert J. Capetola, Ph.D.
President/Chief Executive Officer
Date: August 16, 1999 /s/ Evan Myrianthopoulos
---------------------------------
Evan Myrianthopoulos
Vice President, Finance
(Principal Financial Officer)
Date: August 16, 1999 /s/ Cynthia Davis
---------------------------------
Cynthia Davis
Controller
(Principal Accounting Officer)
Page 14
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
This schedule contains summary financial information extracted from 10-QSB and
is qualified in its entirety by reference to such financial statements.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1999
<PERIOD-START> JAN-01-1999
<PERIOD-END> JUN-30-1999
<CASH> 729,000
<SECURITIES> 1,467,000
<RECEIVABLES> 7,000
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 2,840,000
<PP&E> 465,000
<DEPRECIATION> 145,000
<TOTAL-ASSETS> 3,178,000
<CURRENT-LIABILITIES> 1,088,000
<BONDS> 0
2,379,000
2,000
<COMMON> 7,000
<OTHER-SE> (298,000)
<TOTAL-LIABILITY-AND-EQUITY> 3,178,000
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 1,158,000
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (1,130,000)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (130,000)
<EPS-BASIC> (0.18)
<EPS-DILUTED> (0.18)
</TABLE>
