<PAGE> 1
================================================================================
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------
FORM 10-Q
(MARK ONE)
[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
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 0-22147
ILEX ONCOLOGY, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 74-2699185
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATION OR ORGANIZATION) IDENTIFICATION NO.)
11550 I.H. 10 WEST, SUITE 100
SAN ANTONIO, TEXAS 78230
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (210) 949-8200
----------
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 [ ].
THE NUMBER OF SHARES OUTSTANDING OF THE REGISTRANT'S COMMON STOCK AS OF
AUGUST 1, 2000 IS 24,955,689.
<PAGE> 2
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
INDEX
<TABLE>
<CAPTION>
PART I. FINANCIAL INFORMATION
<S> <C>
ITEM 1. FINANCIAL STATEMENTS
Consolidated Balance Sheets - June 30, 2000, and December 31, 1999 3
Consolidated Statements of Operations - Three and Six Month Periods Ended
June 30, 2000 and 1999 5
Consolidated Statements of Cash Flows - Six Month Period Ended
June 30, 2000 and 1999 6
Notes to Consolidated Financial Statements 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS 11
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 16
PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 17
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K 17
SIGNATURES 18
EXHIBIT 11 - SCHEDULE OF COMPUTATION OF NET LOSS PER SHARE 19
EXHIBIT 27 - FINANCIAL DATA SCHEDULE 20
</TABLE>
2
<PAGE> 3
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Shares and Per Share Amounts)
ASSETS
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
------------ ------------
(Unaudited)
<S> <C> <C>
CURRENT ASSETS:
Cash and cash equivalents $ 58,932 $ 43,477
Investments in marketable securities 86,802 33,758
Restricted investments 1,250 1,400
Receivables, net of allowance for doubtful accounts of $208 and $164 in
2000 and 1999, respectively
Billed 5,116 4,414
Unbilled 2,542 2,484
Employee 16 245
Interest 4,079 1,338
Prepaid expenses and other 1,052 576
------------ ------------
Total current assets 159,789 87,692
------------ ------------
NONCURRENT ASSETS:
Investments in marketable securities 64,817 10,216
Restricted investments -- 275
Investments in and advances to-
Research and development partnerships (4,741) (2,534)
------------ ------------
60,076 7,957
------------ ------------
PROPERTY AND EQUIPMENT, at cost, net of accumulated
depreciation of $4,310 and $3,242 in 2000 and 1999, respectively 5,502 4,705
------------ ------------
Total assets $ 225,367 $ 100,354
============ ============
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
3
<PAGE> 4
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Shares and Per Share Amounts)
LIABILITIES AND STOCKHOLDERS' EQUITY
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
------------- -------------
(Unaudited)
<S> <C> <C>
CURRENT LIABILITIES:
Accounts payable-
Related parties $ 163 $ 165
Other 2,259 2,462
Accrued subcontractor costs-
Related parties 482 739
Other 2,567 1,913
Accrued liabilities 2,717 2,488
Deferred revenue 4,975 2,557
------------- -------------
Total current liabilities 13,163 10,324
------------- -------------
LONG-TERM LIABILITIES 565 369
------------- -------------
13,728 10,693
COMMITMENTS AND CONTINGENCIES (see Note 9)
MINORITY INTEREST 5,232 5,082
STOCKHOLDERS' EQUITY:
Convertible preferred stock, $0.01 par value; 20,000,000 shares
authorized; no shares issued or outstanding -- --
Common stock, $0.01 par value; 100,000,000 shares authorized;
24,899,044 and 21,590,425 shares issued; 24,860,044 and
21,551,425 shares outstanding in 2000 and 1999, respectively 249 216
Additional paid-in capital 292,024 163,821
Accumulated deficit (85,266) (77,338)
Deferred compensation -- (1,603)
Accumulated other comprehensive loss (83) --
Less - Treasury stock at cost; 39,000 shares in 2000 and 1999 (517) (517)
------------- -------------
Total stockholders' equity 206,407 84,579
------------- -------------
Total liabilities and stockholders' equity $ 225,367 $ 100,354
============= =============
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
4
<PAGE> 5
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Amounts)
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
-------- -------- -------- --------
<S> <C> <C> <C> <C>
REVENUE:
Product development $ 621 $ 1,159 $ 1,659 $ 2,069
Contract research services 6,908 3,031 12,484 5,567
-------- -------- -------- --------
Total revenue 7,529 4,190 14,143 7,636
-------- -------- -------- --------
OPERATING EXPENSES:
Research and development costs 6,815 3,944 12,154 7,496
Direct cost of research services 5,636 3,512 10,741 6,500
General and administrative 1,365 1,319 2,304 2,189
Special charges -- 13,882 -- 13,882
-------- -------- -------- --------
Total operating expenses 13,816 22,657 25,199 30,067
-------- -------- -------- --------
OPERATING LOSS (6,287) (18,467) (11,056) (22,431)
OTHER INCOME (EXPENSE):
Equity in losses of-
Research and development partnerships (1,450) (1,264) (1,411) (1,889)
Contract research affiliate -- (3,133) -- (3,310)
Interest income, net 3,316 255 4,832 541
Minority interest in consolidated subsidiary (75) -- (150) --
-------- -------- -------- --------
LOSS BEFORE INCOME TAXES (4,496) (22,609) (7,785) (27,089)
Provision for foreign income taxes 48 -- 143 --
-------- -------- -------- --------
NET LOSS $ (4,544) $(22,609) $ (7,928) $(27,089)
======== ======== ======== ========
BASIC AND DILUTED NET LOSS PER SHARE $ (0.18) $ (1.75) $ (0.34) $ (2.12)
======== ======== ======== ========
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK
OUTSTANDING 24,825 12,916 23,432 12,790
======== ======== ======== ========
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
5
<PAGE> 6
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(Unaudited)
<TABLE>
<CAPTION>
Six Months Ended
June 30,
2000 1999
--------- ---------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (7,928) $ (27,089)
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation and amortization 1,068 1,322
Special charges -- 13,882
Net activity of research and development partnerships and
contract research affiliate 2,207 513
Minority interest 150 --
Deferred compensation expense for consultants options 1,222 --
Changes in operating assets and liabilities:
Increase in receivables, net (3,272) (2,251)
(Increase) decrease in prepaid expenses and other (476) 596
Decrease in other noncurrent assets -- 75
Increase in accounts payable and accrued liabilities 297 200
Increase in deferred revenue 2,418 1,077
Decrease in other long-term liabilities (15) (18)
--------- ---------
Net cash used in operating activities (4,329) (11,693)
--------- ---------
CASH FLOWS FROM INVESTING ACTIVITIES:
Net activity of marketable securities' transactions (107,645) 9,467
Net activity in restricted investments 425 --
Advances to research and development partnership -- (1,000)
Acquisitions, net of cash acquired (136) (380)
Purchase of property and equipment (1,263) (470)
--------- ---------
Net cash (used in) provided by investing activities (108,619) 7,617
--------- ---------
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of common stock for cash, net of issuance costs 127,186 2,692
Collection of receivables on sale of common stock -- 46
Exercise of options and warrants 1,431 --
Principal payments for capital lease obligations (131) --
--------- ---------
Net cash provided by financing activities 128,486 2,738
--------- ---------
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS
(83) --
--------- ---------
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS $ 15,455 $ (1,338)
CASH AND CASH EQUIVALENTS, beginning of period 43,477 6,581
--------- ---------
CASH AND CASH EQUIVALENTS, end of period $ 58,932 $ 5,243
========= =========
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
Non-cash investing and financing activities:
Purchases of equipment under capital leases $ 466 $ --
Cashless exercise of warrants 2 --
Cash paid during the year for-
Interest $ 5 $ --
Income taxes -- --
</TABLE>
The accompanying notes are an integral part of these consolidated
financial statements.
6
<PAGE> 7
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in Thousands, Except Share Information, Per Share Information or As
Otherwise Indicated) (Unaudited)
1. PRINCIPLES OF CONSOLIDATION AND BASIS OF PRESENTATION
The accompanying interim Consolidated Financial Statements presented herein
include the accounts of ILEX Oncology, Inc. and its subsidiaries ("the Company"
or "ILEX"). All significant intercompany transactions and accounts have been
eliminated in consolidation. These interim consolidated financial statements
have been prepared by the Company, without audit, pursuant to the rules and
regulations of the Securities and Exchange Commission. Certain information and
footnote disclosures normally included in financial statements prepared in
accordance with generally accepted accounting principles have been condensed or
omitted pursuant to such rules and regulations. In management's opinion, all
adjustments that are necessary for a fair presentation of financial position and
results of operations have been made.
It is recommended that these interim consolidated financial statements are read
in conjunction with the financial statements and notes thereto included in the
Company's Annual Report on Form 10-K for the year ended December 31, 1999. The
results of operations for any interim period are not necessarily indicative of
the results of operations for the entire year. Certain prior period amounts have
been reclassified to conform to the current period presentation.
2. MERGERS AND ACQUISITIONS
In March 2000, ILEX Oncology Services, Inc. ("ILEX Services") signed a multiyear
services agreement with British Biotech plc to provide contracted drug
development services to complete the ongoing clinical development of the drug,
marimastat, in North America. In conjunction with the signing of the agreement,
ILEX Services acquired the assets, consisting primarily of office equipment, of
the Annapolis, Maryland office of British Biotech for approximately $136.
3. STOCKHOLDERS' EQUITY
In March 2000, the Company sold 3.0 million shares of its common stock at $45
per share to selected institutional and other accredited investors. Gross
proceeds to the Company were approximately $135 million. Net proceeds to the
Company were approximately $127 million. ILEX intends to use the proceeds from
the private placement to accelerate its clinical trials and preclinical
research, with a particular focus on its late-stage clinical product candidates
and preclinical angiogenesis inhibitors, as well as for potential acquisitions
of complementary technologies, products, companies and for general corporate
purposes.
In May 2000, the shareholders unanimously approved a proposal to amend the
Company's Amended and Restated Certificate of Incorporation to increase the
number of authorized shares of the Company's Common Stock from 40 million to 100
million.
In July 1999, the Company acquired Convergence, of Boston, Massachusetts, a
privately held research-based pharmaceutical company with an emerging portfolio
of angiogenesis and DNA repair inhibitors. In connection with the acquisition,
the Company entered into four consulting agreements with the founders of
Convergence. The agreements specify compensation levels and grant the four
founders of Convergence the option to purchase a total of 100,000 shares of the
Company's common stock at an exercise price of $9.94. Previously, the options
vested at a rate of 25 percent per year beginning in July 2000. In April 2000,
the Company elected to accelerate the vesting for the options to 100 percent
vested. Using an option pricing model, the fair value of the options was
calculated as approximately $1.8 million, which resulted in the recognition of
approximately $1.2 million in consulting expense during the current year.
ILEX acquired Convergence in exchange for 1.0 million shares of the Company's
common stock and an additional earn-out of up to 1.0 million shares to be issued
to Convergence's founders, paid out in two equal increments of 500,000 shares,
if certain development milestones are met. The first milestone is defined as the
initiation of treatment of the first patient following initiation of a Phase I
trial in the United States or Europe, which must occur no later than December
31, 2001. The second milestone is defined as the initiation of treatment of the
first patient following initiation of a Phase II trial in the United States or
Europe, which must occur no later than December 31, 2002. The Company believes
the first milestone will be met prior to the end of 2000, and anticipates a
significant non-cash income statement charge at that time.
7
<PAGE> 8
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
4. LOSS PER SHARE
Diluted net loss per share is equal to basic net loss per share, as the effect
of all common stock equivalents is antidilutive.
5. COMPREHENSIVE INCOME
Comprehensive income is defined as the change in equity during a period from
transactions and other events and circumstances from non-owner sources. The
following table presents the components of the Company's comprehensive loss:
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
-------- -------- -------- --------
<S> <C> <C> <C> <C>
Net loss $ (4,544) $(22,609) $ (7,928) $(27,089)
Other comprehensive loss:
Currency translation adjustments (58) -- (83) --
-------- -------- -------- --------
Comprehensive loss $ (4,602) $(22,609) $ (8,011) $(27,089)
======== ======== ======== ========
</TABLE>
6. LICENSING AGREEMENTS
In 1998, ILEX entered into a development agreement with Symphar S.A., a Swiss
company, for the development of APOMINE(TM) (SR-45023A). ILEX and Symphar share
rights to this compound under this agreement. In 2000, Symphar and ILEX amended
their development agreement to allow the Company to make a cash payment in the
amount of $1.0 million in exchange for Symphar's commitment not to exercise its
exclusive right to commercialize APOMINE with any third party for a period of
one year ending April 1, 2001. This payment was made and expensed in the second
quarter of 2000, and is creditable towards the Company's Development Services
commitment under the original agreement.
7. INVESTMENTS IN AND ADVANCES TO RESEARCH AND DEVELOPMENT PARTNERSHIPS
In May 1997, the Company entered into an agreement with LeukoSite, Inc., now
Millennium Pharmaceuticals, Inc. ("Millennium"), for an equally owned joint
venture, L&I Partners, L.P., for research collaboration endeavors. In March
2000, the joint venture changed its name to Millennium & ILEX Partners, L.P.
("M&I Partners"). The Company accounts for its investment in M&I Partners using
the equity method of accounting.
In June 2000, M&I Partners made a $2.5 million payment to BTG International
Limited ("BTG") pursuant to a licensing agreement for CAMPATH. The payment was
due to achieving a milestone under the distribution agreement between the
partnership and Schering AG. The following is summarized financial information
for M&I Partners (unaudited):
Summarized Income Statement Information
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
---- ---- ---- ----
<S> <C> <C> <C> <C>
Revenue $ 2,223 $ - $ 4,408 $ -
Operating expenses 4,984 2,532 6,951 3,818
Operating loss (2,761) (2,532) (2,543) (3,818)
Net loss (2,901) (2,528) (2,822) (3,813)
</TABLE>
Summarized Balance Sheet Information
<TABLE>
<CAPTION>
June 30, December 31,
2000 1999
------------- -------------
<S> <C> <C>
Assets $ 3,865 $ 1,649
Liabilities 13,066 8,029
------------- -------------
Partners' equity $ (9,201) $ (6,380)
============= =============
</TABLE>
8
<PAGE> 9
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
8. EMPLOYEE BENEFITS
The Company has an employee benefit plan and trust for certain employees who
meet specified length of service requirements. The plan qualifies under Section
401(k) of the Internal Revenue Code ("the Code") as a salary reduction plan.
Employees may elect to contribute a certain percentage of their salary on a
before-tax basis upon meeting enrollment requirements. In January 2000, the
Company elected to begin making voluntary contributions to employee accounts.
Employees are immediately fully vested in their contributions and begin vesting
in employer contributions after one year of service, as defined in the plan
document.
In May 2000, the shareholders approved a proposal to ratify the adoption of the
Employee Stock Purchase Plan of the Company. The Purchase Plan allows eligible
employees to purchase shares of Common Stock periodically through their
accumulated payroll deductions during Offering Periods as defined in the
Purchase Plan. Initially, 250,000 shares of Common Stock will be available for
issuance under the Purchase Plan.
Additionally, shareholders approved a proposal to ratify the adoption of the
2000 Employee Stock Compensation Plan of the Company. The Plan authorizes a
committee of the Board of Directors to issue options intended to qualify as
incentive stock options ("ISOs") as defined in Section 422 of the Code, stock
options that are not intended to conform to the requirements of Section 422 of
the Code ("Non-ISOs"), and restricted stock awards. The total number of shares
of Common Stock with respect to which awards may be granted under the Plan is
3.0 million.
9. COMMITMENTS AND CONTINGENCIES
Beginning in April 2000, the Company entered into two capital lease agreements
for office equipment, with lease terms of 36 months and minimum lease payments
of between $5 and $7 per month. The Company has recorded $466 as capital
equipment, and amortization and interest expense was $39 and $5, respectively,
for the six months ended June 30, 2000. At June 30, 2000, the Company had
capital lease obligations of approximately $335, including $124 payable within
one year.
In July 2000, the Company entered into an agreement to lease its future
corporate headquarters. The commencement date of the operating lease is expected
to be October 2000, with a lease term of eight years. Future minimum lease
payments under this new lease agreement will be between $1.2 million and $1.3
million per year, through 2008. The lease required a deposit of approximately
$140. Additionally, in connection with the lease the Company obtained a letter
of credit, with the lessor as beneficiary, in the amount of $2.8 million. The
letter of credit is fully collateralized with $3.6 million in restricted cash.
The Company will utilize the existing office lease space for excess capacity
until a sublease is arranged or the lease expires in December 2003.
9
<PAGE> 10
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
10. SEGMENT REPORTING
The Company has two reportable segments: ILEX Products and ILEX Services. ILEX
Products develops proprietary compounds for the treatment and prevention of
cancer. ILEX Services provides contract research services for the development,
manufacturing, and regulatory approval of oncology compounds. The Company's
reportable segments are strategic business units that are managed separately, as
each business requires different technology and marketing strategies.
The Company has reclassified certain prior year income statement amounts between
its two operating segments for purposes of comparability with current year
presentation. The effect of these reclassifications for the three and six months
ended June 30, 1999 is to increase the cost of contract research services and to
decrease corporate general & administrative costs by $181 and $325,
respectively. The accounting policies of the segments are the same as those of
the Company. The Company evaluates performance based on the profit or loss from
operations before income taxes.
Selected Segment Information
<TABLE>
<CAPTION>
Three Months Ended June 30, 2000 Six Months Ended June 30, 2000
------------------------------------ -------------------------------------
Services Products Total Services Products Total
---------- ---------- ---------- ---------- ---------- ----------
<S> <C> <C> <C> <C> <C> <C>
Revenue from external customers $ 6,908 $ 621 $ 7,529 $ 12,484 $ 1,659 $ 14,143
Intersegment revenue 2,835 - 2,835 5,248 - 5,248
---------- ---------- ---------- ---------- ---------- ----------
Total revenue 9,743 621 10,364 17,732 1,659 19,391
Direct costs 6,998 8,288 15,286 13,273 14,870 28,143
---------- ---------- ---------- ---------- ---------- ----------
Segment operating income (loss) 2,745 (7,667) (4,922) 4,459 (13,211) (8,752)
Equity in losses of partnerships - (1,450) (1,450) - (1,411) (1,411)
---------- ---------- ---------- ---------- ---------- ----------
Segment net income (loss) $ 2,745 $ (9,117) $ (6,372) $ 4,459 $ (14,622) $ (10,163)
========== ========== ========== ========== ========== ==========
Total Assets $ 17,681 $ (2,319) $ 15,362
Corporate 276,327
Elimination of intersegment balances (66,322)
----------
Consolidated total assets $ 225,367
=========
</TABLE>
<TABLE>
<CAPTION>
Three Months Ended June 30, 1999 Six Months Ended June 30, 1999
-------------------------------------- ---------------------------------------
Services Products Total Services Products Total
---------- ---------- ---------- ---------- ---------- ----------
<S> <C> <C> <C> <C> <C> <C>
Revenue from external customers $ 3,031 $ 1,159 $ 4,190 $ 5,567 $ 2,069 $ 7,636
Intersegment revenue 2,462 - 2,462 5,684 - 5,684
---------- ---------- ---------- ---------- ---------- ----------
Total revenue 5,493 1,159 6,652 11,251 2,069 13,320
Direct costs 5,337 4,581 9,918 10,521 9,159 19,680
Special charges 12,847 8 12,855 12,847 8 12,855
---------- ---------- ---------- ---------- ---------- ----------
Segment operating loss (12,691) (3,430) (16,121) (12,117) (7,098) (19,215)
Equity in losses of partnerships (3,133) (1,264) (4,397) (3,310) (1,889) (5,199)
---------- ---------- ---------- ---------- ---------- ----------
Segment net loss $ (15,824) $ (4,694) $ (20,518) $ (15,427) $ (8,987) $ (24,414)
========== ========== ========== ========== ========== ==========
Total Assets $ 8,898 $ 1,819 $ 10,717
Corporate 57,700
Elimination of intersegment balances (41,406)
----------
Consolidated total assets $ 27,011
==========
</TABLE>
10
<PAGE> 11
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
Reconciliation of Segment Information to Consolidated Totals
<TABLE>
<CAPTION>
Three Months Ended Six Months Ended
June 30, June 30,
-------------------- --------------------
2000 1999 2000 1999
-------- -------- -------- --------
<S> <C> <C> <C> <C>
Research and development costs:
Reportable products segment direct costs $ 8,288 $ 4,581 $ 14,870 $ 9,159
Elimination of intersegment gross profit (1,473) (637) (2,716) (1,663)
-------- -------- -------- --------
Consolidated research and development costs $ 6,815 $ 3,944 $ 12,154 $ 7,496
======== ======== ======== ========
Direct costs of research services:
Reportable services segment direct costs $ 6,998 $ 5,337 $ 13,273 $ 10,521
Elimination of intersegment expenses (1,362) (1,825) (2,532) (4,021)
-------- -------- -------- --------
Consolidated direct costs of research services $ 5,636 $ 3,512 $ 10,741 $ 6,500
======== ======== ======== ========
Operating net loss:
Reportable segment operating loss $ (4,922) $(16,121) $ (8,752) $(19,215)
Corporate general and administrative expenses (1,365) (1,319) (2,304) (2,189)
Special charges - (1,027) - (1,027)
-------- -------- -------- --------
Consolidated operating loss $ (6,287) $(18,467) $(11,056) $(22,431)
======== ======== ======== ========
Net loss:
Reportable segment net loss $ (6,372) $(20,518) $(10,163) $(24,414)
Corporate general and administrative expenses (1,365) (1,319) (2,304) (2,189)
Special charges - (1,027) - (1,027)
Interest income, net 3,316 255 4,832 541
Minority interest in consolidated subsidiary (75) - (150) -
Provision for foreign income taxes (48) - (143) -
-------- -------- -------- --------
Consolidated net loss $ (4,544) $(22,609) $ (7,928) $(27,089)
======== ======== ======== ========
</TABLE>
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
11. SUBSEQUENT EVENT
In July 2000, the Company signed an agreement to license a drug compound and
incurred a $1.0 million license issue fee. The Company may be required to make
future license maintenance fees in either cash or unrestricted stock in
accordance with the agreement if certain drug development and time based
milestones are met.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion is included to describe the Company's financial
position and results of operations for the three and six month periods ended
June 30, 2000. The Consolidated Financial Statements and notes thereto contain
detailed information that should be referred to in conjunction with this
discussion.
GENERAL
ILEX Oncology, Inc. (the "Company" or "ILEX") develops pharmaceuticals
for treating and preventing cancer and provides contract research services to
other companies developing anticancer drugs. We have a portfolio of seven
anticancer products in clinical development and several preclinical stage
products. We built this portfolio by in-licensing and acquiring product
candidates developed by others and do not conduct early-stage drug discovery
research ourselves.
We operate through two reportable segments: ILEX Products, through which
we develop our own portfolio of anticancer compounds, and ILEX Services, which
is our full service oncology-focused contract research organization ("CRO").
ILEX Services manages the preclinical research and clinical trials for our own
product candidates as well as oncology products being developed by other
companies. In addition to building our expertise in cancer drug development, our
CRO business generates revenue, reduces our cost to perform our own research and
development, and gives us access to product in-licensing opportunities.
11
<PAGE> 12
ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
We are continuing to make progress with our lead product candidate,
CAMPATH(R) (alemtuzumab), which is being developed in partnership with
Millennium Pharmaceuticals, Inc. The partnership, Millennium & ILEX Partners,
L.P. ("M&I Partners") submitted the Biologics License Application ("BLA") to the
U.S. Food and Drug Administration ("FDA") for CAMPATH in December 1999. The
application was accepted for filing in February 2000. CAMPATH is an
investigational humanized monoclonal antibody. It has received "fast track"
designation from the FDA. The FDA has granted orphan drug designation to
CAMPATH.
We received a complete response letter from the FDA in June 2000, in
which the FDA delineated the deficiencies noted after complete review of the
licensing application. These deficiencies need to be resolved to complete the
review of the application for consideration for marketing approval. M&I Partners
is responding rapidly to the FDA letter, and the agency is expected to
reinitiate its review upon receipt of the partnership's complete response.
Additionally, the Marketing Authorization Application for CAMPATH was
accepted for review in April 2000 by the European Agency for the Evaluation of
Medicinal Products ("EMEA"). The application, which was submitted in late March,
will be reviewed under the EMEA's centralized procedure, required for
biotechnology products. The application is based largely on the results of a
pivotal clinical trial, which were first reported at the European Haematology
Association meeting in Barcelona, Spain in June 1999. We are continuing to work
constructively with the agency to obtain approval in European markets.
We currently have no products available for sale. We have incurred
losses since inception and had an accumulated deficit through June 30, 2000 of
$85.3 million. Our losses have resulted primarily from product development
activities, including in-licensing of products for which we pay fees, and
related administrative expenses. We expect to continue to incur operating losses
for the next several years. To date we have not generated any significant
revenue from the sale of our drug candidates.
Our revenue for the foreseeable future will be limited to product
development funding under our collaborative relationships, our CRO revenue,
interest income, and other miscellaneous income. In addition, if marketing
approval is received from the FDA with respect to our lead product candidate,
CAMPATH, and if CAMPATH is successfully commercialized, we will receive a
portion of the profits generated by its sale. M&I Partners may not obtain
marketing approval of CAMPATH, successfully commercialize it, or ever generate
profits from its sale.
We have significantly contributed to the development of CAMPATH on
behalf of M&I Partners. M&I Partners pays us for these services. We have
historically accounted for these CAMPATH development activities as follows:
o our operating revenue includes product development revenue we receive from
M&I Partners;
o our research and development expenses include all of our development costs
for CAMPATH, which are largely offset by M&I Partners' revenue we receive;
and
o our actual share of CAMPATH operating losses are reported as equity in
losses of research and development partnerships.
Our CRO business generates revenue by performing services for companies
within the pharmaceutical and biotechnology industries. The terms of our
contracts vary, ranging from several months to two years, and generally may be
terminated upon notice of 60 to 90 days by our customers. We recognize revenue
with respect to our services either on a percentage-of-completion or
fee-for-service basis as work is performed. The CRO business performs all of the
development services for ILEX Products; however, our consolidated CRO revenue
does not include any amounts related to the services provided to ILEX Products.
RESULTS OF OPERATIONS - SIX MONTHS ENDED JUNE 30, 2000 AND 1999
OPERATING REVENUES
Total revenue increased to $14.1 million in the first six months of
2000, from $7.6 million in the first six months of 1999. The increase of $6.5
million, or 86%, was due to an additional $6.9 million in CRO revenue, partially
offset by a slight decrease of $0.4 million in product development revenues. The
increase of $6.9 million, or 123%, in CRO revenues to $12.5 million in 2000,
compared to $5.6 million in 1999, reflects an increase in the number of
contracts in process with existing clients, as well as an expansion in the
client base. Additionally, the increase in CRO revenues is attributable to an
increase in the effective hourly billing rate.
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OPERATING EXPENSES
Total Operating Expenses. Excluding special charges totaling $13.9
million incurred in the first six months of 1999, total operating expenses
increased to $25.2 million in the first six months of 2000 from $16.2 million in
1999. This increase of $9.0 million, or 56%, is due to a $4.2 million increase
in direct costs of research services, as well as a $4.7 million increase in
research and development costs during the first six months of 2000. ILEX
believes that research and development costs will continue to increase in future
periods as the Company expands its preclinical and clinical trials associated
with developing additional compounds.
Research and Development Costs. Research and development costs increased
to $12.2 million in the first six months of 2000, from $7.5 million in 1999.
This increase of $4.7 million, or 63%, was due to an increase in resources
devoted to developing the Company's product pipeline, particularly its
angiogenesis inhibitor pipeline, as well as license payments totaling $2.3
million relating to products in the ILEX pipeline. Additionally, the Company
recognized $1.2 million in consulting expense during the first six months of
2000, related to the options issued in connection with the acquisition of
Convergence.
Direct Cost of Research Services. Direct cost of research services
expense increased to $10.7 million during the first six months of 2000, from
$6.5 million in 1999. This increase of $4.2 million, or 65%, is attributable to
an increase in the number of active new contracts, including the size and
complexity of contract research projects. Additionally, as a result of the
increasing number of contracts, the number of employees related to CRO services
has increased almost 20% to approximately 200 at June 30, 2000.
General and Administrative Costs. General and administrative costs
remained relatively constant at $2.3 million for the first six months of 2000,
compared to $2.2 million in 1999. This reflects the Company's commitment to
controlling overall general and administrative costs.
OPERATING LOSS
Excluding special charges in the aggregate amount of $13.9 million
incurred in the prior year, loss from operations increased to $11.1 million in
the first six months of 2000, from $8.5 million in 1999. This increase of $2.6
million, or 31%, is due to an increase in research and development expenses,
partially offset by improved profitability of the Company's CRO business, which
had operating income of $1.8 million for the first six months of 2000, compared
to an operating loss of $0.9 million in 1999.
EQUITY IN LOSSES OF RESEARCH AND DEVELOPMENT PARTNERSHIPS AND CONTRACT RESEARCH
AFFILIATE
Equity in losses of research and development partnerships was $1.4
million for the first six months of 2000, compared to $1.9 million in 1999, or a
decrease of $0.5 million, or 26%. This decrease is due to advances made to the
partnership from a third party, as required by a distribution and development
agreement, partially offset by license fees of $2.5 million incurred by the
partnership in June 2000. Additionally, in the first six months of 1999 we
incurred a loss of $3.3 million related to an agreement with a contract research
affiliate. This agreement was subsequently terminated in June 1999, as
previously discussed in our 1999 Annual Report on Form 10-K.
NET INTEREST INCOME
Net interest income increased to $4.8 million in 2000, from $0.5 million
in 1999. This increase of $4.3 million, or 860%, is attributable to an increase
in average cash and investment balances during the first six months of 2000, as
a result of proceeds received from a common stock offering during the last six
months of 1999, as well as a private placement in March 2000.
NET LOSS
Net loss decreased $19.2 million during 2000, or 71%, to $7.9 million,
from $27.1 million in 1999. Net loss per share decreased $1.78 per share to
$0.34 per share in 2000, from $2.12 per share in 1999, due to a reduction in the
net loss primarily as a result of special charges of $13.9 million incurred in
1999, as well as an increase in the weighted average number of shares
outstanding due to recent stock offerings.
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--------------------------------------------------------------------------------
RESULTS OF OPERATIONS - THREE MONTHS ENDED JUNE 30, 2000 AND 1999
OPERATING REVENUES
Total revenue increased to $7.5 million in the second quarter of 2000,
from $4.2 million in the second quarter of 1999. The increase of $3.3 million,
or 79%, was due to an additional $3.9 million of CRO revenues, partially offset
by a decrease of $0.5 million in product development revenues. The increase of
$3.9 million, or 130%, in CRO revenues to $6.9 million for the quarter in 2000,
compared to $3.0 million in the same quarter in 1999, reflects an increase in
the number of active contracts in process with existing clients, improved labor
utilization, and an increase in the effective hourly billing rate.
OPERATING EXPENSES
Total Operating Expenses. Excluding special charges totaling $13.9
million incurred in the second quarter of 1999, total operating expenses
increased to $13.8 million in the second quarter of 2000 from $8.8 million in
1999. This increase of $5.0 million, or 57%, is due to an increase during the
first six months of 2000 in direct costs of research services, as well as an
increase in research and development costs. As mentioned previously, ILEX
believes that research and development costs will continue to increase in future
periods as the Company expands its preclinical research and clinical trials
associated with developing additional compounds.
Research and Development Costs. Research and development costs increased
to $6.8 million in the second quarter of 2000, from $3.9 million in 1999. This
increase of $2.9 million, or 74%, was due to an increase in resources devoted to
developing the Company's product pipeline, as well as license payments totaling
$2.3 million relating to products in the ILEX pipeline.
Direct Cost of Research Services. Direct cost of research services
expense increased to $5.6 million during the second quarter of 2000, from $3.5
million in 1999. This increase of $2.1 million, or 60%, is attributable to the
addition of new contracts, including the size and complexity of contract
research projects. Additionally, as a result of the increasing number of
contracts, the number of employees related to CRO services has increased almost
20% to approximately 200 at June 30, 2000.
General and Administrative Costs. General and administrative costs
remained relatively constant at $1.4 million for the second quarter of 2000,
compared to $1.3 million for the same quarter in 1999. This reflects the
Company's commitment to controlling overall general and administrative costs.
OPERATING LOSS
Excluding special charges in the aggregate amount of $13.9 million
incurred in the prior year, loss from operations increased to $6.3 million in
the second quarter of 2000, from $4.6 million in 1999. This increase of $1.7
million, or 37%, is due to increased research and development expense,
partially offset by improved profitability of the Company's CRO business, which
had operating income of $1.3 million for the second quarter of 2000, compared
to an operating loss of $0.5 million in the same quarter of 1999.
EQUITY IN LOSSES OF RESEARCH AND DEVELOPMENT PARTNERSHIPS AND CONTRACT RESEARCH
AFFILIATE
Equity in losses of research and development partnerships was $1.5
million for the second quarter of 2000, compared to $1.3 million in 1999, an
increase of $0.2 million, or 15%. This increase is primarily attributable to
license fees of $2.5 million incurred by the partnership in June 2000, partially
offset by advances made to the partnership from a third party, as required by a
distribution and development agreement. Additionally, in the second quarter of
1999 we incurred a loss of $3.1 million related to an agreement with a contract
research affiliate. This agreement was subsequently terminated in June 1999, as
previously discussed in our 1999 Annual Report on Form 10-K.
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JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
NET INTEREST INCOME
Net interest income increased to $3.3 million in 2000, from $0.3 million
in 1999. This increase of $3.0 million, or 1,000%, is attributable to an
increase in average cash and investment balances during the first six months of
the year, as a result of proceeds received from common stock offerings during
the last six months of 1999, as well as a private placement in March 2000.
NET LOSS
Net loss decreased $18.1 million for the second quarter 2000, or 80%, to $4.5
million, from $22.6 million in 1999. Net loss per share decreased $1.57 per
share to $0.18 per share in 2000, from $1.75 per share in 1999, due to a
reduction in the net loss primarily as a result of the special charges of $13.9
million incurred in 1999, as well as an increase in the weighted average number
of shares outstanding due to recent stock offerings.
LIQUIDITY AND CAPITAL RESOURCES
ILEX has historically financed its operations primarily through the sale
of its capital stock, through development and licensing fee revenues provided by
its collaborative partners under its collaborative agreements and through
fee-for-service or participatory revenues pursuant to contracts with its CRO
clients. We receive payments under collaborative agreements primarily in the
form of development funding, milestone payments, and royalties for
commercialized products.
In March 2000, we sold 3.0 million shares of common stock at $45 per
share to selected institutional and other accredited investors in a private
placement. Gross proceeds to the Company were approximately $135 million. Net
proceeds to the Company were approximately $127 million.
At June 30, 2000, we had cash, cash equivalents, restricted investments
and investments in marketable securities of $211.8 million and working capital
of $146.6 million. Cash, cash equivalents, restricted investments and
investments in marketable securities increased $122.7 million compared to
December 31, 1999, primarily as a result of the private placement previously
mentioned, partially offset by general operating requirements, including capital
purchases and licensing fees. Our cash requirements are expected to continue to
increase each year as we expand our activities and operations. It is possible we
will never be able to generate significant product revenue or achieve or sustain
profitability.
Until our business can generate sufficient levels of cash from product
sales, we expect to continue to finance our operations through existing cash,
revenue from collaborative relationships, CRO revenue, and proceeds from the
sale of equity securities. Under the terms of our agreement with IMPATH Inc.,
ILEX Services is prohibited from incurring any debt without IMPATH's consent. We
plan to continue our policy of investing available funds in government
securities and investment-grade, interest-bearing securities, primarily with
maturities of one year or less. We do not invest in derivative financial
instruments, as defined by Statement of Financial Accounting Standards No. 119.
Our future expenditures and capital requirements will depend on numerous
factors, including without limitation, the progress of our research and
development programs, the progress of our preclinical and clinical testing, the
magnitude and scope of these activities, the time and costs involved in
obtaining regulatory approvals, the cost of filing, prosecuting, defending and
enforcing any patent claims and other intellectual property rights, competing
technological and market developments, changes in or termination of existing
collaborative arrangements, our ability to establish, maintain and avoid
termination of collaborative arrangements, and the purchase of capital equipment
and acquisitions of compounds, technologies or businesses. Our cash requirements
are expected to continue to increase each year as we expand our activities and
operations. At June 30, 2000, we had no material commitments for capital
expenditures. There can be no assurance that we will ever be able to generate
product revenue or achieve or sustain profitability.
We believe our existing cash, cash equivalents, and marketable
securities will be adequate to support our operations for the near term,
including any potential acquisitions or in-licensing opportunities. There can be
no assurance, however, that we will not require additional financing in the
future, or that such additional funding, if needed, will be available on terms
acceptable to us or at all.
FORWARD-LOOKING STATEMENTS - CAUTIONARY STATEMENTS
This Quarterly Report on Form 10-Q contains certain "forward-looking"
statements as such term is defined in the Private Securities Litigation Reform
Act of 1995 and information relating to the Company and its subsidiaries that
are based on the beliefs of the Company's management as well as assumptions made
by and information currently available to the
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JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
Company's management. When used in this report, the words "anticipate,"
"believe," "estimate," "expect" and "intend" and words or phrases of similar
import, as they relate to the Company or its subsidiaries or Company management,
are intended to identify forward-looking statements. Such statements reflect the
current risks, uncertainties and assumptions related to certain factors
including, without limitations, competitive factors, general economic
conditions, failure to receive FDA approval of our drugs, including CAMPATH,
relationships with pharmaceutical and biotechnology companies, the ability to
develop safe and efficacious drugs, variability of royalty, license and other
revenue, failure to satisfy performance obligations, ability to enter into
future collaboration agreements, failure to achieve positive results in clinical
trials, failure to complete current or secure new contracts with contract
research services clients, uncertainty regarding the Company's patents and
proprietary rights (including the risk that the Company may be forced to engage
in costly litigation to protect such patent rights and the material adverse
consequences to the Company if there were unfavorable outcome of any such
litigation), governmental regulation and supervision, technological change,
changes in industry practices, one-time events and other factors described
herein or in the Company's Registration Statement on Form S-3 (Registration File
No. 333-32000) filed March 8, 2000, and the Company's annual, quarterly and
other reports filed with the Securities and Exchange Commission. Based upon
changing conditions, should any one or more of these risks or uncertainties
materialize, or should any underlying assumptions prove incorrect, actual
results may vary materially from those described herein as anticipated,
believed, estimated, expected or intended. The Company does not intend to update
these forward-looking statements.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market risk represents the risk of loss that may impact the financial
position, results of operations, or cash flows of the Company due to adverse
changes in financial market prices, including interest rate risk, foreign
currency exchange rate risk, commodity price risk, and other relevant market
rate or price risks.
We are exposed to some market risk through interest rates, related to
our investment of cash, cash equivalents, restricted investments and investments
in marketable securities of $211.8 million at June 30, 2000. These funds are
generally invested in highly liquid treasury bills, money market accounts with
short-term maturities and corporate bonds. As such instruments mature and the
funds are reinvested, we are exposed to changes in market interest rates. This
risk is not considered material and we manage such risk by continuing to
evaluate the best investment rates available for short-term high quality
investments. We have not used derivative financial instruments in our investment
portfolio.
Our European operations are denominated in local currency. We have
unhedged transaction exposures in these currencies which are not considered
material. We have not entered into any forward foreign exchange contracts for
speculative, trading or other purposes.
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ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The following matters were voted upon at the Annual Meeting of
Stockholders held on May 25, 2000, and received the votes set forth
below:
1. A proposal to amend the Company's Amended and Restated Certificate
of Incorporation to increase the number of authorized shares of the
Company's Common Stock from 40 million shares to 100 million shares
received 19,156,354 votes FOR and 739,996 votes AGAINST, with 23,993
abstentions.
2. A proposal to ratify of the Adoption of the Company's Employee Stock
Purchase Plan received 17,475,479 votes FOR and 51,903 votes AGAINST,
with 25,457 abstentions.
3. A proposal to ratify the adoption of the Company's 2000 Employee
Stock Compensation Plan received 15,591,626 votes FOR and 1,932,181
votes AGAINST, with 29,032 abstentions.
4. All of the following persons nominated were elected to serve as
directors and received the number of votes set forth opposite their
respective names:
<TABLE>
<CAPTION>
NAME FOR WITHHELD
---- --- --------
<S> <C> <C>
Richard L. Love 19,660,393 259,950
Gary V. Woods 19,660,393 259,950
Glenn C. Rice, Ph.D. 19,660,393 259,950
Joseph S. Bailes, M.D. 19,660,393 259,950
John L. Cassis 19,660,393 259,950
Jason S. Fisherman, M.D. 19,660,393 259,950
Ruskin C. Norman, M.D. 19,660,393 259,950
Daniel D. Von Hoff, M.D. 19,660,393 259,950
</TABLE>
5. A proposal to ratify the appointment of Independent Public
Accountants received 19,911,456 votes FOR and 1,287 votes AGAINST, with
7,200 abstentions.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
Exhibit
Number
3.1* Restated Certificate of Incorporation of the Company
10.1* 2000 Employee Stock Compensation Plan for the Company
10.2* Employee Stock Purchase Plan for the Company
11.1* Computation of Net Loss Per Share
27.1* Financial Data Schedule
(b) Reports on Form 8-K:
During the three-month period ending June 30, 2000, no current reports on
Form 8-K were filed.
* Filed herewith.
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ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Act of
1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized, in the city of San Antonio, Texas,
on August 4, 2000.
ILEX ONCOLOGY, INC.
By: /s/ RICHARD L. LOVE
-----------------------
Richard L. Love
President and Chief Executive Officer
(Principal Executive Officer)
By: /s/ GREGORY L. WEAVER
-------------------------
Gregory L. Weaver
Vice President and Chief Financial Officer
(Chief Financial and Accounting Officer)
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ILEX ONCOLOGY, INC.
JUNE 30, 2000 - QUARTERLY REPORT ON FORM 10-Q
--------------------------------------------------------------------------------
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBIT
NUMBER DESCRIPTION
------- -----------
<S> <C>
3.1* Restated Certificate of Incorporation of the Company
10.1* 2000 Employee Stock Compensation Plan for the Company
10.2* Employee Stock Purchase Plan for the Company
11.1* Computation of Net Loss Per Share
27.1* Financial Data Schedule
* Filed herewith
</TABLE>
