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FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20459
[x] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2000
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from to .
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Commission file number 0-20713
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ENTREMED, INC.
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(Exact name of registrant as specified in its charter)
Delaware 58-1959440
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(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
9640 Medical Center Drive
Rockville, Maryland
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(Address of principal executive offices)
20850
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(Zip code)
(301) 217-9858
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(Registrant's telephone number, including area code)
Indicate by check mark whether the Registrant (1) has filed all reports required
to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the Registrant
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
YES X NO
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Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the most recent practicable date.
Class Outstanding at August 8, 2000
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Common Stock $.01 Par Value 16,778,238
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ENTREMED, INC.
<TABLE>
<CAPTION>
Table of Contents
PART I. FINANCIAL INFORMATION PAGE
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<S> <C>
Item 1 -- Financial Statements
Consolidated Balance Sheets
as of June 30, 2000 and December 31, 1999 3
Consolidated Statements of
Operations for the Three Months Ended
June 30, 2000 and 1999, and the Six Months
Ended June 30, 2000 and 1999 4
Consolidated Statements of Cash
Flows for the Six Months Ended June 30, 2000
and 1999 5
Notes to Consolidated Financial
Statements 6
Item 2 -- Management's Discussion and Analysis
of Financial Condition and Results of
Operations 8
Part II. OTHER INFORMATION
Item 1 -- Legal Proceedings 11
Item 2 -- Changes in Securities 11
Item 3 -- Defaults upon Senior Securities 11
Item 4 -- Submission of Matters to Vote of
Security Holders 11
Item 5 -- Other Information 11
Item 6 -- Exhibits and Reports on Form 8-K 12
SIGNATURES 13
</TABLE>
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ENTREMED, INC.
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
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(unaudited)
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 50,049,567 $ 26,027,235
Interest receivable 131,416 105,482
Accounts receivable 862,062 618,598
Prepaid expenses and other 279,732 336,443
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Total current assets 51,322,777 27,087,758
Furniture and equipment, net 4,029,473 4,013,785
Other assets 602,294 742,082
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Total assets $ 55,954,544 $ 31,843,625
===================== ====================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 4,545,250 $ 4,887,693
Accrued liabilities 1,846,315 1,756,538
Deferred revenue - 75,000
Notes payable 952,540 1,125,620
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Total current liabilities 7,344,105 7,844,851
Note payable, less current portion 1,508,137 1,995,327
Minority interest 18,371 18,646
Stockholders' equity:
Convertible preferred stock, $1.00 par and $1.50 Liquidation value:
5,000,000 shares authorized, none issued and
outstanding at June 30, 2000 (unaudited)
and December 31, 1999 - -
Common stock, $.01 par value:
35,000,000 shares authorized, 17,068,898 (unaudited)
and 14,755,998 shares issued and outstanding at
June 30, 2000 and December 31, 1999, respectively 170,689 147,560
Treasury stock, at cost: 291,667 shares held
June 30, 2000 (unaudited) and December 31, 1999 (3,833,379) (3,833,379)
Additional paid-in capital 156,715,336 107,863,638
Accumulated deficit (105,968,715) (82,193,018)
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Total stockholders' equity 47,083,931 21,984,801
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Total liabilities and stockholders' equity $ 55,954,544 $ 31,843,625
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</TABLE>
The accompanying notes are an integral part of the financial statements.
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ENTREMED, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Three Months Ended Six months ended
June 30, June 30,
2000 1999 2000 1999
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<S> <C> <C> <C> <C>
Revenues:
Collaborative research and development $ - $ 1,042,500 $ - $ 2,085,000
Licensing - 50,000 - 100,000
Grant 135,718 - 228,225 158,819
Royalty 731,223 236,531 1,256,150 428,211
Other - - 109,265 1,040
------------ ------------ ------------ --------------
Total revenues 866,941 1,329,031 1,593,640 2,773,070
------------ ------------ ------------ --------------
Expenses:
Research and development 11,226,701 7,619,140 20,297,905 14,726,595
General and administrative 3,201,378 2,003,069 5,898,394 3,898,907
------------ ------------ ------------ -------------
14,428,079 9,622,209 26,196,299 18,625,502
Interest expense (63,125) - (112,916) -
Investment income 489,855 284,873 939,878 695,287
------------ ------------ ------------ -------------
Net loss $(13,134,408) $(8,008,305) $(23,775,697) $(15,157,145)
============ ============ ============ =============
Net loss per share (basic and diluted) $ (0.84) $ (0.61) $ (1.57) $ (1.15)
============ ============ ============ =============
Weighted average number of shares
outstanding (basic and diluted) 15,549,080 13,165,522 15,190,495 13,144,832
============ ============ ============ ==============
</TABLE>
The accompanying notes are an integral part of the financial statements.
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ENTREMED, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
Six Months Ended
June 30,
2000 1999
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<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (23,775,697) $(15,157,145)
Adjustments to reconcile net loss to net cash
used by operating activities:
Depreciation 496,457 457,489
Loss on equity investment 120,000 -
Loss on disposal of furniture and equipment - 65,674
Minority interest (275) 8,803
Changes in assets and liabilities:
Accounts receivable (243,464) (246,477)
Interest receivable (25,934) 113,564
Prepaid expenses and other 76,499 161,078
Accounts payable (342,443) 1,378,022
Accrued liabilities 89,777 (133,167)
Deferred revenue (75,000) (1,573,333)
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Net cash used by operating activities (23,680,080) (14,925,492)
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CASH FLOWS FROM INVESTING ACTIVITIES
Maturities of short-term investments - 2,850,526
Purchases of furniture and equipment (512,145) (1,625,996)
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Net cash (used) provided by investing activities (512,145) 1,224,530
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CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from option and warrant exercises
and the sale of common stock 48,874,827 396,506
Payment on note payable (660,270) -
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Net cash provided by financing activities 48,214,557 396,506
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Net increase (decrease) in cash and cash equivalents 24,022,332 (13,304,456)
Cash and cash equivalents at beginning of period 26,027,235 30,818,689
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Cash and cash equivalents at end of period $ 50,049,567 $ 17,514,233
================== ==================
</TABLE>
The accompanying notes are an integral part of the financial statements.
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ENTREMED, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2000 (unaudited)
1. BASIS OF PRESENTATION
Our accompanying unaudited consolidated financial information
includes the accounts of our 85% owned subsidiary, Cytokine Sciences, Inc. and
our 97.5% owned subsidiary TheraMed Inc. Cytokine Sciences was formed in June
1996 and was capitalized with $250,000 from us for the purpose of acquiring the
assets of Innovative Therapeutics, Inc., which acquisition was completed in July
1996 in exchange for 15% of the common stock of Cytokine Sciences, Inc. TheraMed
Inc. was formed in July 1998 as a wholly owned subsidiary. On April 1, 2000
TheraMed Inc. was capitalized with $39,000 from us and $1,000 from a minority
investor. We also agreed to contribute certain technology and to provide
additional funding in exchange for preferred stock. We have further agreed to
provide facility and administrative services for which TheraMed Inc. is
obligated to repay us. TheraMed Inc. will focus on the continued development and
the commercialization of blood cell permeation technology.
The accompanying unaudited consolidated financial statements have
been prepared in accordance with generally accepted accounting principles for
interim financial information and in accordance with the instructions to Form
10-Q and Article 10 of Regulation S-X. Accordingly, such consolidated financial
statements do not include all of the information and disclosures required by
generally accepted accounting principles for complete financial statements. In
the opinion of our management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been included.
Operating results for the six month period ended June 30, 2000 are not
necessarily indicative of the results that may be expected for the year ending
December 31, 2000. For further information, refer to our audited financial
statements and footnotes thereto included in our Form 10-K for the year ended
December 31, 1999.
2. CONTINGENCIES
We are a defendant in a lawsuit initiated in August 1995 in the
United States District Court for the Eastern District of Tennessee by Bolling,
McCool & Twist ("BMT"), a consulting firm. In the suit, BMT asserts that we
breached an agreement between BMT and us by failing to pay BMT certain fees it
asserts are owed under the agreement. More specifically, BMT has asserted a
claim for the payment of services rendered in the approximate amount of $50,000
and seeks a success fee in an unspecified amount in connection with the BMS
Collaboration. The judge in the case bifurcated the proceeding into two phases:
an adjudication of whether we breached our agreement with BMT and then a damage
phase. After a trial on the merits the jury found in favor of BMT on the breach
of contract claim. A trial to determine damages had been scheduled for April 14,
1998. However, on April 6, 1998, the court issued an Order pursuant to which
damages were limited to those arising during the term of the Agreement, which
terminated on November 1, 1995. On May 6, 1999, the court confirmed its decision
by granting our motion for summary judgement and limiting our damages to
approximately $50,000 plus interest. Thus, this litigation at the trial level
has been concluded. BMT has filed an appeal and we have cross-appealed. We can
not predict the outcome of such appeal. However, we intend to continue to
contest any further action vigorously and believe that this proceeding will not
have a material adverse effect on us or on our financial condition, although
there can be no assurance that this will be the case.
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On May 30, 2000, Abbott Laboratories filed a law suit against
Children's Medical Center Corporation and us in the Federal District Court in
Massachusetts requesting, among other things, that the court substitute Dr.
Donald Davidson as inventor on Children's U.S. Patent No. 4,854,221 which covers
use of the Kringle 5 region of the plasminogen molecule as an anti-angiogenic
agent and a declaratory judgement from the court to invalidate any agreement
between Children's Hospital and EntreMed regarding this patent. Abbott also
filed a claim for misappropriation of trade secrets related to the Kringle 5
molecule seeking actual and punitive damages from the defendants. On July 18,
2000, we filed counterclaims against Abbott Laboratories including tortuous
interference with contract and a declaratory judgement that Abbott's patent
covering Kringle 5 is invalid and that Children's patent covering Kringle 5 is
valid. Although we do not currently believe that the Abbott lawsuit will have a
material impact on the operations of the company, and we intend to vigorously
contest the allegations raised in the lawsuit, there is a risk that Children's
patent or any agreement with Children's with respect to the use of the patent
could be invalidated or found not to exist.
The Abbott lawsuit is not directed to nor does the suit affect our
Angiostatin molecule, Kringles 1-3 of the plasminogen molecule, that is
currently in Phase I clinical trial.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS.
(a) Overview
Since our inception in September 1991, we have devoted substantially
all of our efforts and resources to sponsoring and conducting research and
development on our own behalf and through collaborations. Through June 30, 2000,
with the exception of license fees, research and development funding, royalty
payments, and certain research grants, we have not generated any revenue from
operations. We anticipate our primary revenue sources for the next several years
to include royalty payments, research grants and collaboration payments from
collaborators under arrangements entered into in the future. The timing and
amounts of such revenues, if any, will likely fluctuate and depend upon the
achievement of specified research and development milestones, and results of
operations for any period may be unrelated to the results of operations for any
other period.
Results of Operations
Three and Six Months Ended June 30, 2000 and June 30, 1999
Revenues decreased approximately 35% from approximately $1,329,000
for the three months ended June 30, 1999 ("1999 Three Months") to approximately
$867,000 for the three months ended June 30, 2000 ("2000 Three Months"). For the
six months ended June 30, 2000 ("2000 Six Months"), revenues were approximately
$1,594,000 as compared to $2,773,000 the six months ended June 30, 1999 ("1999
Six Months"), a 43% decrease. These decreases result from the absence of BMS
collaborative research and development fees and license fees. BMS collaborative
research and development fees and license fees recognized totaled approximately
$2,185,000 for the 1999 Six Months. This decrease was partially offset by an
increase in royalty income of approximately 193% from approximately $428,000 for
the 1999 Six Months to approximately $1,256,000 for the 2000 Six Months, as well
as an increase in grant revenue of approximately 43%, from approximately
$159,000 for the 1999 Six Months to approximately $228,000 for the 2000 Six
Months. The increase in royalty income is primarily due to royalty income
received from Celgene on the sale of THALOMID(R).
Research and development expenses increased by approximately 47% from
approximately $7,619,000 for the 1999 Three Months to approximately $11,227,000
for the 2000 Three Months and by approximately 38% from approximately
$14,727,000 for the 1999 Six Months to approximately $20,298,000 in the 2000 Six
Months. Research and development expenditures include sponsored research
payments to academic collaborators, including payments to Children's Hospital of
$700,000 in 2000 and $1,000,000 in 1999 and expenses related to our internal
research programs. The increase in internal research expenses resulted primarily
from the increased efforts in manufacturing of our three product candidates,
Endostatin, Angiostatin and 2ME2, supporting our clinical trial programs, and
our internal and sponsored research and product development programs relating to
our antiangiogenesis and blood cell permeation technologies. Overall, research
personnel increased from 54 as of June 30, 1999 to 71 as of June 30, 2000.
Research and development expenses are expected to continue to increase as we
expand our research and development efforts.
General and administrative expenses increased approximately 60% from
approximately $2,003,000 for the 1999 Three Months to approximately $3,201,000
for the 2000 Three Months. For the 2000 Six Months general and administrative
expenses were approximately $5,898,000 as compared to approximately $3,899,000
for the 1999 Six Months, a 51% increase. The 2000 Six Months increase resulted
primarily from the increase in administrative costs associated with adding
administrative staff to
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support our research efforts and external collaborations, investigating
potential strategic relationships, and obtaining professional services.
Investment income increased approximately 72% from approximately
$285,000 for the 1999 Three Months to approximately $490,000 for the 2000 Three
Months and increased approximately 35% from approximately $695,000 in the 1999
Six Months to approximately $940,000 in the 2000 Six Months. This overall
increase in investment income during the 2000 periods versus comparable periods
of 1999 is due to an increase in our invested cash resulting from the sale of
our common stock.
(b) Liquidity and Capital Resources
We anticipate incurring substantial additional losses over at least
the next several years due to, among other factors, the need to expend
substantial amounts on our ongoing and planned clinical trials, additional
research and development activities, and related business development and
general corporate expenses. From inception through June 30, 2000, we have
financed our operations from:
- the net proceeds of private placements of equity securities which
raised approximately $17,000,000;
- payments from Bristol-Myers Squibb, including $9,700,000 received in
December 1995 (of which $6,500,000 was an equity investment),
$11,535,000 received in 1996 (of which $5,000,000 was an equity
investment), $3,670,000 in each of the years 1997 and 1998, $611,667
in 1999;
- various grants from the World Health Organization and SBIR grants
totaling approximately $1,371,000;
- our June 1996 Initial Public Offering ("IPO") which raised net
proceeds of approximately $43,541,000;
- proceeds of approximately $654,000 under capital leases;
- a private offering completed on July 27, 1999 of 1,478,118 shares of
our common stock, Series 1 Warrants to purchase a total of 739,059
shares of common stock at an exercise price of $33.02 and Series 2
Warrants to purchase a total of 739,059 shares of common stock at an
exercise price of $25.45, resulting in net proceeds to us of
approximately $28,400,000;
- exercise of warrants issued in connection with the private offering
which have resulted in additional proceeds to us of approximately
$24,200,000 through June 30, 2000;
- proceeds of $3,000,000 from a borrowing in December 1999 secured by
substantially all of our furniture and equipment; and
- a public offering completed June 19, 2000 of 1,000,000 shares of our
common stock resulting in net proceeds to us of approximately
$20,680,000.
The Series 1 Warrants issued in connection with the private offering
completed on July 27, 1999, are terminable by us at any time after January 27,
2002 if our common stock trades at a per share price greater than $61.91 for ten
consecutive trading days and such Warrants are not exercised within a specified
period after our delivery of a written notice. If the Series 1 Warrants were
fully exercised, they would result in us receiving $24,400,000 in aggregate
exercise proceeds. We terminated the Series 2 Warrants under a similar provision
on June 1, 2000. We received aggregate proceeds of approximately $17,818,000
from the exercise of the Series 2 Warrants.
In December 1999, we exercised our option to repurchase 291,667 of
our common shares from BMS for $13.143 a share or a total repurchase price of
$3,833,379 and which is reflected as treasury stock in the accompanying
consolidated balance sheets. BMS's remaining 583,332 shares held in connection
with the collaborative research and development agreement are subject to certain
restrictions, including future repurchase rights which expire in December 2000
and 2001.
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At June 30, 2000, we had cash and cash equivalents of approximately
$50,050,000 with working capital of approximately $43,979,000, primarily
representing the net proceeds of our private placements of equity securities and
our initial public offering, payments from BMS which include equity investments,
royalties received from Celgene, proceeds from secured borrowing and various
grants.
Our cash resources have been used to finance research and
development, including sponsored research, capital expenditures, including
leasehold improvements to our new facility, and general and administrative
expenses. Over the next several years, we expect to incur substantial additional
research and development costs, including costs related to early-stage research,
preclinical and clinical trials, product manufacturing, increased administrative
expenses to support our research and development operations and increased
capital expenditures for expanded research capacity, various equipment needs and
facility improvements.
We are a party to sponsored research agreements requiring us to fund
an aggregate of approximately $2,498,000 through 2001 (including $1,550,000 to
Children's Hospital, Boston); clinical trial agreements of approximately
$819,000; a production agreement for clinical trial drug substance of an
estimated $9,000,000; license agreements requiring future milestone payments of
up to $3,435,000; and additional payments upon attainment of regulatory
milestones.
We believe that our existing resources will be sufficient to meet our
planned expenditures over the next twelve months, although there can be no
assurance we will not require additional funds. Our working capital requirements
will depend upon numerous factors including:
- the progress of our research and development programs;
- our ability to contain our manufacturing costs;
- preclinical testing and clinical trials;
- achievement of regulatory milestones;
- the timing and cost of seeking regulatory approvals;
- the level of resources that we devote to the development of
manufacturing, marketing and sales capabilities, if any;
- technological advances;
- the status of competing products; and
- our ability to maintain existing and establish new collaborative
arrangements with other companies to provide us with funding to
support these activities.
We will require substantial funds in addition to the present existing
working capital to develop our product candidates and to meet our business
objectives.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable.
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PART II. OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
This information as set forth in Note 2 of "Notes to Consolidated
Financial Statements" appearing in Item 1 of Part I of this report is
incorporated herein by reference.
Item 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
Not applicable.
Item 3. DEFAULT UPON SENIOR SECURITIES
Not applicable.
Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
(a) The Company's annual meeting of stockholders was held on June 22,
2000 ("Annual Meeting").
(b) Not applicable.
(c) At the Annual Meeting, the stockholders considered and approved the
following proposals:
(i) Election of Directors. The following sets forth the nominees
who were elected Directors of the Company for the term expiring in the year
indicated as well as the number of votes case for, against, or withheld:
<TABLE>
<CAPTION>
Year Term Expires Name Votes For Votes Against Withheld
----------------------------- -------------------------- --------------------------- -------------------------- ------------------
<S> <C> <C> <C> <C>
2003 John W. Holaday 13,473,103 86,018 0
----------------------------- -------------------------- --------------------------- -------------------------- ------------------
2003 Wendell M. Starke 13,473,103 86,018 0
----------------------------- -------------------------- --------------------------- -------------------------- ------------------
2001 Peter S. Knight 13,473,103 86,018 0
----------------------------- -------------------------- --------------------------- -------------------------- ------------------
</TABLE>
(ii) Increase Number of Shares under 1999 Long-Term Incentive Plan.
At the Annual Meeting the stockholders approved an amendment to the Company's
1999 Long-Term Incentive Plan (the "1999 Plan"), increasing from 750,000 to
1,750,000 the number of shares of Common Stock reserved for issuance under the
1999 Plan. This proposal received 5,906,553 votes in favor, 744,212 votes
against and 43,474 abstentions. In addition, 6,864,882 shares were not voted.
(iii) Ratification of Appointment of Ernst & Young LLP. At the
Annual Meeting, stockholders approved and ratified the selection of Ernst &
Young LLP as the independent auditors. The proposal received 13,513,515 votes in
favor, 29,084 votes against and 16,522 abstentions.
Item 5. OTHER INFORMATION
Not applicable.
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Item 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
10.38* Manufacturing Services Agreement between the Company
and Chiron Corporation, dated April 13, 2000
27.1 Financial Data Schedule
*Portions of this Exhibit have been omitted pursuant to a
Confidential Treatment Request, which the Company has filed
separately with the Securities and Exchange Commission.
(b) Reports on Form 8-K
(i) On June 13, 2000, the Company filed a Form 8-K advising of the
Abbott Laboratories lawsuit described above in Note 2 to the
Financial Statements.
(ii)On June 15, 2000, the Company filed a Form 8-K advising of its
agreement with Bank of America Securities LLC to act as
underwriter for its public offering completed June 19, 2000.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
ENTREMED, INC.
(Registrant)
Date: August 11, 2000 /s/ John W. Holaday
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John W. Holaday, Ph.D.
President and Chief Executive Officer
Date: August 11, 2000 /s/ R. Nelson Campbell
--------------------------------------------
R. Nelson Campbell
Chief Financial Officer
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