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 Quarterly Period Ended March 31, 2000
or
[ ] Transition Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
For Transition Period from __________ to __________
Commission File No. 0-14710
XOMA Ltd.
(Exact Name of Registrant as specified in its charter)
Bermuda 94-2756657
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
2910 Seventh Street, Berkeley, CA 94710
(Address of principal executive offices) (Zip Code)
(510) 644-1170
(Registrant's telephone number, including area code)
Not Applicable
(Former name, former address and former
fiscal year, if changed since last report)
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.
Common shares US$.0005 par value 65,375,846
- ------------------------------------- -----------------------------------
Class Outstanding at March 31, 2000
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XOMA Ltd.
TABLE OF CONTENTS
Page
----
PART I FINANCIAL INFORMATION
Item 1 Consolidated Financial Statements
Condensed Consolidated Balance Sheets as of March 31, 2000 and
December 31, 1999 ..................................................1
Condensed Consolidated Statements of Operations for the
Three Months Ended March 31, 2000 and 1999 .........................2
Condensed Consolidated Statements of Cash Flows for the
Three Months Ended March 31, 2000 and 1999 .........................3
Notes to Condensed Consolidated Financial Statements ...............4
Item 2 Management's Discussion and Analysis of Financial
Condition and Results of Operations ..............................7
PART II OTHER INFORMATION
Items 1 through 3 and 5 are either inapplicable or nonexistent and
therefore are omitted from this report
Item 4 Submission of Matters to a Vote of Security
Holders..........................................................10
Item 6 Exhibits and Reports on Form 8-K.................................10
Signatures ................................................................11
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<TABLE>
<CAPTION>
XOMA Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
March 31, 2000 December 31, 1999
(Unaudited) (Note 1)
-------------- -----------------
Assets:
<S> <C> <C>
Cash and cash equivalents $ 50,355 $ 18,539
Short-term investments 1,387 --
Related party receivable 219 219
Other receivables 2,460 658
Prepaid expenses and other 113 679
Total current assets 54,534 20,095
----------- -----------
Property and equipment, net 3,506 3,651
Assets held for sale 4,442 4,442
Deposits and other 164 124
----------- -----------
$ 62,646 $ 28,312
=========== ===========
Liabilities and Shareholders' Equity:
Accounts payable $ 2,589 $ 3,915
Accrued liabilities 5,405 6,519
Deferred revenue - current 3,333 --
----------- -----------
Total current liabilities 11,327 10,434
Deferred revenue-long term 6,111 --
Convertible subordinated notes 34,050 34,724
----------- -----------
Total liabilities 51,488 45,158
Shareholders' equity (net capital deficiency) 11,158 (16,846)
----------- -----------
$ 62,646 $ 28,312
=========== ===========
</TABLE>
Note 1 - Amounts derived from the Company's amended annual report on Form 10-K
as filed with the SEC.
See accompanying notes to condensed consolidated financial statements.
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<TABLE>
<CAPTION>
XOMA Ltd.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, in thousands except per share data)
Three Months Ended
March 31,
----------------------
2000 1999
----------------------
Revenues:
<S> <C> <C>
License fees $ 562 $ 17
Product sales and royalties 10 3
Contract revenue 2,000 --
---------- ----------
2,572 20
---------- ----------
Operating costs and expenses:
Research and development 7,194 12,273
General and administrative 1,526 1,380
---------- ----------
8,720 13,653
---------- ----------
Loss from operations (6,148) (13,633)
Other income (expense):
Investment and other income 490 369
Interest and other expense (626) (394)
---------- ----------
Net loss (6,284) (13,658)
Preference share dividends -- (55)
---------- ----------
Net loss available to common shareholders $ (6,284) $ (13,713)
========== ==========
Net loss per common share $(0.10) $(0.28)
========== ==========
Shares used in computing net loss per common share 61,629 49,163
---------- ----------
</TABLE>
See accompanying notes to condensed consolidated financial statements.
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<PAGE>
<TABLE>
<CAPTION>
XOMA Ltd.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited, in thousands)
Three Months Ended
March 31,
-------------------
2000 1999
-------------------
CASH FLOWS FROM OPERATING ACTIVITIES:
<S> <C> <C>
Net cash provided by (used in) operating activities $ 310 $ (11,096)
---------- ----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of short-term investments -- 18,854
Payments for purchase of short-term investments -- (14,376)
Capital expenditures (174) (210)
---------- ----------
Net cash provided by (used in) investing activities (174) 4,268
---------- ----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common shares, net 32,980 11,391
Payments on convertible notes (1,300) --
Capital lease principal payments -- (105)
---------- ----------
Net cash provided by (used in) financing activities 31,680 11,286
---------- ----------
Net increase (decrease) in cash and cash equivalents 31,816 4,458
Cash and cash equivalents at beginning of period 18,539 11,857
---------- ----------
Cash and cash equivalents at end of period $ 50,355 $ 16,315
========== ==========
</TABLE>
See accompanying notes to condensed consolidated financial statements.
-3-
<PAGE>
XOMA Ltd.
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(Unaudited)
1. Basis of Presentation
The interim information contained in this report is unaudited but, in
management's opinion, includes all normal recurring adjustments necessary for a
fair presentation of results for the periods presented. Interim results may not
be indicative of results to be expected for the full year. The consolidated
financial statements should be read in conjunction with the Company's audited
consolidated financial statements for the year ended December 31, 1999 included
in its Annual Report on Form 10-K.
2. Recent Accounting Pronouncements
In December 1999, the Securities and Exchange Commission (SEC) issued Staff
Accounting Bulletin No. 101 (SAB 101), "Revenue Recognition in Financial
Statements." SAB 101 summarizes certain areas in applying generally accepted
accounting principles to revenue recognition in financial statements. In March
2000, the SEC issued SAB101A to defer for one quarter the effective date of
implementation of SAB101 with earlier application encouraged. The Company has
implemented the revenue recognition guidelines as outlined in SAB101 for
preparation of its first quarter 2000 results of operations.
In June 1998, the FASB issued SFAS No. 133, "Accounting for Derivative
Instruments and Hedging Activities." XOMA is required to adopt SFAS No. 133 for
the year ending December 31, 2002. Because the Company currently holds no
derivative financial instruments and does not currently engage in hedging
activities, adoption of SFAS No. 133 is expected to have no material impact on
the Company's financial position or results of operations.
In March 2000, the FASB issued Interpretation No. 44, "Accounting for
Certain Transactions Involving Stock Compensation," which provides guidance on
several implementation issues related to Accounting Principles Board Opinion No.
25 (APB 25). The most significant are clarification of the definition of
employee for purposes of applying APB 25 and the accounting for options that
have been repriced. Under the interpretation, the employer-employee relationship
would be based on case law and Internal Revenue Service regulations. The FASB
granted an exception to this definition for outside directors. Under the
interpretation, repriced options effectively changed the terms of the plan,
which would make it a variable plan subject to compensation expense. The impact
of the interpretation on the Company's position and results of operations is not
expected to be material.
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<PAGE>
3. Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
March 31, December 31,
2000 1999
----------- ------------
Accrued payroll costs $ 2,517 $ 2,928
Accrued clinical trial costs 1,950 2,957
Other 938 634
----------- ------------
$ 5,405 $ 6,519
=========== ============
4. Private Placement
In February 2000, the Company issued 6,145,000 common shares for net
proceeds of $29.0 million. The Company also issued five-year warrants to
purchase a total of up to 250,000 common shares for $5.00 per share to its
placement agents in this transaction. These warrants were exercisable upon
issuance and expire in February 2005.
5. Comprehensive Loss
Comprehensive loss includes certain changes in equity that are excluded
from net loss. Specifically, unrealized holding gains and losses in available
for sale investments, which were reported separately in shareholders' equity,
are included in accumulated other comprehensive income (loss). Comprehensive
loss and its components for the quarters ended March 31, 2000 and 1999 are as
follows (in thousands):
<TABLE>
<CAPTION>
Three Months Ended
March 31,
-------------------------------
2000 1999
------------ -------------
<S> <C> <C>
Net loss $ (6,284) $ (13,713)
Unrealized gain on securities available-for-sale 887 --
------------ -------------
Comprehensive loss $ (5,397) $ (13,713)
============ =============
</TABLE>
6. Net Loss Per Common Share
Basic and diluted net loss per common share is based on the weighted
average number of common shares outstanding during the period in accordance with
Financial Accounting Standard No. 128. Common share equivalents were not
included because they are antidilutive.
-5-
<PAGE>
7. Subsequent Event
In an April meeting with members of the U.S. Food and Drug Administration
(FDA), representatives from XOMA and its licensee, the Hyland Immuno Division of
Baxter Healthcare Corporation, discussed results from the Phase III trial that
tested NEUPREX(R) (rBPI21) in pediatric patients with severe meningococcemia.
Senior representatives of the FDA indicated that the data presented were not
sufficient to support the filing of a biologics license application (BLA) at
this time. XOMA and Baxter are therefore examining ways to supply the additional
data necessary to proceed with the filing. Because of this event, the filing of
a BLA will be delayed, but by how long is not known at this time.
-6-
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Results of Operations:
Revenues in the first quarter of 2000 were $2.6 million, and were negligible in
the first quarter of 1999. Following recent SEC guidance on revenue recognition,
revenues in the 2000 quarter include only a portion of a $10 million upfront
payment received in January related to the licensing of NEUPREX(R). A remaining
unrecognized balance of $9.4 million will be recognized ratably over future
periods. Research and development expenses decreased to $7.2 million in the
first three months of 2000, compared with $12.3 million in the 1999 period. The
decrease was due primarily to lower spending on clinical trials for the
NEUPREX(R) and anti-CD11a products. General and administrative spending was $1.5
million in the first three months of 2000 compared to $1.4 million in the first
quarter of 1999.
Investment income was higher in the first three months of 2000 compared to 1999
due to a higher average investment balance.
Liquidity and Capital Resources:
The Company's cash, cash equivalents and short-term investments totaled $51.7
million as of March 31, 2000, up from $18.5 million at December 31, 1999. Net
cash used in operating activities plus capital expenditures were offset by the
net proceeds from common shares issued in February 2000 and a $10 million
initial payment from Baxter under the agreement of January 2000. Net cash
provided from operating activities was $0.3 million in the first three months of
2000, compared with a net usage of $11.1 million in the comparable1999 period.
The decrease in usage was primarily due to lower amounts paid for clinical
trials and preparation of regulatory filings and the $10 million initial payment
from Baxter. The Company's cash, cash equivalents and short-term investments are
expected to continue to decrease while the Company pursues U.S. Food and Drug
Administration licensure except to the extent the Company secures additional
funding.
The Company has been able to control its operating cash consumption by carefully
monitoring its costs. As a result, its cash position and resulting investment
income are sufficient to finance the Company's currently anticipated levels of
spending through at least the second quarter of 2002. Strategic arrangements
with Allergan, Inc., Baxter and Genentech, Inc. have reduced Company spending
levels by paying certain product development costs. The Company continues to
evaluate a variety of arrangements that would further strengthen its competitive
position and provide additional funding, but cannot predict when or whether any
such arrangement or additional funding will be secured. Without additional
funding, the Company would have to decrease or eliminate the development of some
of its products.
-7-
<PAGE>
Year 2000 Exposure:
XOMA has not experienced any problems with its computer systems systems being
unable to recognize appropriate dates related to the Year 2000. The Company is
not aware that any clients or vendors have experienced material problems with
this issue. Accordingly, XOMA does not anticipate incurring material expenses or
experiencing any material operational disruptions as a result of any Year 2000
issues.
Quantitative and Qualitative Disclosures About Market Risk:
Interest Rate Risk. The Company's exposure to market rate risk due to changes in
interest rates relates primarily to the Company's investment portfolio. The
Company does not use derivative financial instruments in its investment
portfolio. By policy, the Company places its investments with high quality debt
security issuers, limits the amount of credit exposure to any one issuer, limits
duration by restricting the term and holds investments to maturity except under
rare circumstances. The Company classifies its cash equivalents as fixed rate if
the rate of return on an instrument remains fixed over its term. As of March 31,
2000, all the Company's cash equivalents are classified as fixed rate.
The Company also has a long-term convertible note due to Genentech in 2005.
Interest on this note of LIBOR plus 1% is reset at the end of June and December
each year and is therefore variable.
The table below presents the amounts and related weighted interest rates of the
Company's cash equivalents and long-term convertible note at March 31, 2000:
<TABLE>
<CAPTION>
Fair Value Average
Maturity ($ in millions) Interest Rate
------------- --------------- -------------
<S> <C> <C> <C>
Cash equivalents, fixed rate daily $ 50.4 6.1%
Long-term convertible note, variable rate 2005 34.1 7.1%
</TABLE>
Other Market Risk. At March 31, 2000 the Company had a long-term convertible
note outstanding which is convertible into common shares based on the market
price of the Company's common shares at the time of conversion. A 10% decrease
in the market price of the Company's common shares would increase the number of
shares issuable upon conversion of either security by approximately 11%. An
increase in the market price of Company common shares of 10% would decrease the
shares issuable by approximately 9%.
-8-
<PAGE>
Forward Looking Statements:
Certain statements contained herein that are not related to historical facts may
constitute "forward looking" information, as that term is defined in the Private
Securities Litigation Reform Act of 1995. Such statements are based on the
Company's current beliefs as to the outcome and timing of future events, and
actual results may differ materially from those projected or implied in the
forward looking statements. Further, certain forward looking statements are
based upon assumptions of future events which may not prove to be accurate. The
forward looking statements involve risks and uncertainties including, but not
limited to, those related to regulatory approvals, product efficacy and
development, the Company's financing needs and opportunities, scale-up and
marketing capabilities, intellectual property protection, competition, stock
price volatility and other risk factors referred to herein and in other of the
Company's Securities and Exchange Commission filings.
-9-
<PAGE>
PART II - OTHER INFORMATION
Item 1 Legal Proceedings. None.
Item 2 Changes in Securities. None.
Item 3 Defaults Upon Senior Securities. None.
Item 4 Submission of Matters to a Vote of Security Holders.
On January 31, 2000, the Company held a special general meeting of
shareholders, at which the increase of the Company's authorized share
capital by 65,000,000 Common Shares was approved, having received
50,225,390 votes for, 3,374,183 votes against, no votes withheld, 239,053
abstentions and no broker non-votes.
Item 5 Other Information. None.
Item 6 Exhibits and Reports on Form 8-K.
(a) Exhibit 10.1 Sixth Amendment to License Agreement dated January 25,
2000 between the Company and New York University (with
certain confidential information omitted, which omitted
information is the subject of a confidential treatment
request and has been filed separately with the
Securities and Exchange Commission).
Exhibit 27.1 Financial Data Schedule
(b) Current Report on Form 8-K dated January 24, 2000 and filed on
January 25, 2000, as amended by an amendment on Form 8-K/A dated
and filed on February 3, 2000 (File No. 0-14710), Items 5 (Other
Events) and 7 (Exhibits).
Current Report on Form 8-K dated February 11, 2000 filed on
February 14, 2000 (File No. 0-14710), Items 5 (Other Events)
and 7 (Exhibits).
-10-
<PAGE>
XOMA Ltd.
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.
XOMA LTD.
Date: May 12, 2000 By: /s/ JOHN L. CASTELLO
------------------------------
John L. Castello
Chairman of the Board, President
and Chief Executive Officer
Date: May 12, 2000 By: /s/ PETER B. DAVIS
-------------------------------
Peter B. Davis
Vice President, Finance and
Chief Financial Officer
-11-
EXHIBIT 10.1
[*] indicates that a confidential portion of the text of this agreement has
been omitted
SIXTH AMENDMENT TO LICENSE AGREEMENT
This Sixth Amendment to License Agreement (hereinafter "Amendment") is made
and effective on January 25, 2000, among XOMA TECHNOLOGY LTD., a company
organized and existing under the laws of Bermuda and having a place of business
at 2910 Seventh Street, Berkeley, California 94710 and XOMA IRELAND LIMITED, a
company organized and existing under the laws of Ireland and having a place of
business at Shannon Airport House, Shannon, Co. Clare, Ireland (hereinafter
collectively referred to as "CORPORATION"), and NEW YORK UNIVERSITY, a
corporation organized and existing under the laws of the State of New York and
having a place of business at 70 Washington Square South, New York, New York
10012 (hereinafter "NYU").
WITNESSETH
WHEREAS, CORPORATION's predecessor in interest and NYU entered into a
certain agreement made and effective as of August 6, 1990, as amended and
restated on September 1, 1993 and as subsequently amended on August 1, 1996,
June 12, 1997, December 23, 1998 and June 25, 1999 (as so amended and restated,
the "Agreement"), pursuant to which, inter alia, CORPORATION's predecessor in
interest undertook to sponsor the
<PAGE>
-2-
NYU Research Project (as such term is defined in the Agreement) and NYU granted
to CORPORATION's predecessor in interest the License (as such term is defined in
the Agreement); and
WHEREAS, CORPORATION and NYU wish to amend the Agreement as specified
herein;
NOW, THEREFORE, in consideration of the premises and the covenants,
conditions and promises set forth below, the parties hereto hereby agree as
follows:
1. Except as expressly provided for herein, all terms and conditions of
the Agreement shall remain in full force and effect.
2. Terms which are defined in the Agreement shall have the same meanings
when used in this Amendment, unless a different definition is given
herein.
3. The second clause (i.e., the language after the first semicolon) of
Subsection 7.c.(3) of the Agreement (after giving effect to the Fifth
Amendment thereto) shall be, and hereby is, amended by adding [*]
[*]
4. The proviso (i.e., the language after the first semicolon) in the last
sentence of Subsection 9.e. of the
<PAGE>
-3-
Agreement (after giving effect to the Fifth Amendment thereto) shall
be, and hereby is, amended by adding "(1)" after the words "Products
for" and before the words "the mitigation" and by adding the following
language after the word "mammals" and before the words "in the event":
or (2) antibacterial and/or anti-endotoxin uses, in human clinical
indications (including, but not limited to, meningococcemia and future
indications but excluding periodontitis indications and ophthalmic
indications), in which the therapeutic action of the product involves
one or more of: (x) the binding and/or neutralization of
lipopolysaccharide or endotoxin which is on or released from gram
negative bacteria, thereby interrupting the inflammatory cascade
potentially leading to septicemia/sepsis, (y) killing of gram negative
or gram positive bacteria and (z) enhancing the ability of antibiotics
to kill gram negative or gram positive bacteria, including, but not
limited to, reversal of bacterial resistance to antibiotics,
5. This Amendment may be executed in one or more counterparts, each of
which shall be an original and all of which shall constitute together
the same document.
<PAGE>
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IN WITNESS WHEREOF, the parties hereto have executed this Amendment as
follows:
NEW YORK UNIVERSITY XOMA TECHNOLOGY LTD.
By:____________________________________ By:_________________________________
Isaac T. Kohlberg G. James Reynolds
Vice Provost Director
XOMA IRELAND LIMITED
SIGNED by
----------------------------
Alan Kane, Director,
duly authorized for and on behalf
of XOMA IRELAND LIMITED in the
presence of:
------------------------------
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> Dec-31-1999
<PERIOD-END> Mar-31-1999
<CASH> 50,355
<SECURITIES> 1,387
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 54,534
<PP&E> 32,187
<DEPRECIATION> 28,681
<TOTAL-ASSETS> 62,646
<CURRENT-LIABILITIES> 11,327
<BONDS> 0
0
0
<COMMON> 33
<OTHER-SE> 11,125
<TOTAL-LIABILITY-AND-EQUITY> 62,646
<SALES> 0
<TOTAL-REVENUES> 2,572
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 8,720
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 626
<INCOME-PRETAX> (6,284)
<INCOME-TAX> 0
<INCOME-CONTINUING> (6,284)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (6,284)
<EPS-BASIC> (0.10)
<EPS-DILUTED> (0.10)
</TABLE>
