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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(MARK ONE)
|X| QUARTERLY REPORT PURSUANT TO SECTION 13 OF 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 1997 OR
| | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
COMMISSION FILE NUMBER 0-22769
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LEUKOSITE, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 04-3173859
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
215 FIRST STREET 02142
CAMBRIDGE, MASSACHUSETTS (Zip Code)
(Address of principal executive offices)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (617) 621-9350
----------------------------
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 each of the registrant's classes of
common stock as of:
DATE CLASS OUTSTANDING SHARES
October 31, 1997 Common stock, $.01 par value 9,538,343
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LEUKOSITE, INC.
(A Development Stage Company)
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 1997
TABLE OF CONTENTS
<TABLE>
<CAPTION>
PAGE NUMBERING IN
SEQUENTIAL NUMBERING SYSTEM
---------------------------
<S> <C> <C>
PART I FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
Condensed Consolidated Balance Sheets as of
December 31, 1996 and September 30, 1997 3
Condensed Consolidated Statements of Operations for the three
and nine months ended September 30, 1996 and September 30,
1997, and for the Period from Inception
(May 1, 1992) to September 30, 1997 4
Condensed Consolidated Statements of Cash Flows for the nine
months ended September 30, 1996 and September 30, 1997, and
for the Period from Inception (May 1, 1992) to
September 30, 1997 5
Notes to Condensed Consolidated Financial Statements 6
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations 9
PART II OTHER INFORMATION
Items 1-6 Other Information 14
Signatures 16
</TABLE>
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PART I FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
LEUKOSITE, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
DECEMBER 31, 1996 SEPTEMBER 30,1997
----------------- -----------------
(UNAUDITED)
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 4,430,507 $ 16,975,247
Marketable securities 4,953,902 8,025,631
Other current assets 153,779 297,249
------------ ------------
Total current assets 9,538,188 25,298,127
------------ ------------
Property and equipment, net of accumulated depreciation
and amortization 2,308,456 2,154,391
------------ ------------
Other assets 27,526 27,090
------------ ------------
Total assets $ 11,874,170 $ 27,479,608
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable and accrued expenses $ 1,162,098 $ 2,382,860
Obligation to fund L&I Joint Venture -- 996,900
Deferred revenue 261,250 1,836,250
Deferred rent, current portion 104,357 238,421
Current portion of capital lease obligations 784,168 688,382
------------ ------------
Total current liabilities 2,311,873 6,142,813
------------ ------------
Deferred rent, net of current portion 466,078 283,700
------------ ------------
Capital lease obligations, less current portion 763,621 536,270
------------ ------------
Redeemable convertible preferred stock 20,913,405 --
------------ ------------
Stockholders' equity (deficit):
Preferred stock $.01 par value-
Authorized-5,000,000 shares
Issued and outstanding-no shares -- --
Convertible preferred stock 22,500 --
Common stock, $.01 par value-
Authorized - 25,000,000 shares
Issued and outstanding - 1,086,590 shares at
December 31, 1996 and 9,537,158 shares at
September 30, 1997 10,866 95,372
Additional paid-in capital 8,710,149 49,325,106
Deficit accumulated during the development stage (21,324,322) (28,903,653)
------------ ------------
Total stockholders' equity (deficit) (12,580,807) 20,516,825
------------ ------------
Total liabilities and stockholders'equity (deficit) $ 11,874,170 $ 27,479,608
============ ============
</TABLE>
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LEUKOSITE, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS ENDED SEPTEMBER 30, NINE MONTHS ENDED SEPTEMBER 30, INCEPTION
(MAY 1, 1992)
THROUGH
1996 1997 1996 1997 SEPT. 30,1997
----------- ----------- ----------- ----------- ------------
<S> <C> <C> <C> <C> <C>
REVENUES:
Corporate collaborations $ 783,750 $ 1,558,750 $ 1,307,250 $ 3,628,774 $ 7,469,774
Government grants 82,770 50,948 82,770 256,370 539,140
----------- ----------- ----------- ----------- ------------
Total revenue 866,520 1,609,698 1,390,020 3,885,144 8,008,914
----------- ----------- ----------- ----------- ------------
OPERATING EXPENSES:
Research and development 2,357,026 3,053,638 6,281,654 8,505,075 30,694,962
General and administrative 371,596 371,879 866,870 1,107,441 4,661,721
----------- ----------- ----------- ----------- ------------
Total operating expenses 2,728,622 3,425,517 7,148,524 9,612,516 35,356,683
----------- ----------- ----------- ----------- ------------
LOSS FROM OPERATIONS (1,862,102) (1,815,819) (5,758,504) (5,727,372) (27,347,769)
OTHER INCOME (EXPENSE):
Equity in operations of joint
venture -- (1,649,400) -- (1,649,400) (1,649,400)
Interest income 97,254 235,031 269,393 529,825 1,333,994
Interest expense (47,831) (39,027) (156,988) (122,384) (630,478)
----------- ----------- ----------- ----------- ------------
NET LOSS $(1,812,679) $(3,269,215) $(5,646,099) $(6,969,331) $(28,293,653)
=========== =========== =========== =========== ============
PRO FORMA NET LOSS PER COMMON SHARE
$ (.31) $ (.40) $ (.96) $ (.98)
=========== =========== =========== ===========
SHARES USED IN COMPUTING PRO FORMA
NET LOSS PER COMMON SHARE 5,905,630 8,086,371 5,890,206 7,119,956
=========== =========== =========== ===========
</TABLE>
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LEUKOSITE, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
INCEPTION
NINE MONTHS ENDED (MAY 1, 1992)
SEPTEMBER 30, THROUGH
1996 1997 SEPT. 30, 1997
----------- ------------ --------------
<S> <C> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $(5,646,099) $ (6,969,331) $(28,293,653)
Adjustments to reconcile net loss to net
cash used in operating activities:
Stock compensation expense -- -- 89,339
Depreciation and amortization 725,000 884,999 2,836,784
Equity in operations of joint venture -- 1,649,400 1,649,400
Change in operating assets and liabilities:
Other current assets (166,527) (143,470) (297,249)
Accounts payable and accrued expenses 632,364 1,220,762 2,949,562
Deferred revenue 511,250 1,575,000 1,836,250
Deferred rent 154,725 (48,314) 522,121
----------- ------------ ------------
Net cash used in operating activities (3,789,287) (1,830,954) (18,707,446)
----------- ------------ ------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Investment in marketable securities (6,705,007) (10,923,111) (27,920,588)
Proceeds from maturities of marketable securities 2,798,261 7,851,382 19,894,957
Investment in joint venture -- (652,500) (652,500)
Purchases of property and equipment (70,446) (432,388) (2,218,948)
Decrease (increase) in other assets (205,431) 436 (27,090)
----------- ------------ ------------
Net cash used in investing activities (4,182,623) (4,156,181) (10,924,169)
----------- ------------ ------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Principal payments on capital leases (389,621) (621,682) (2,023,776)
Net proceeds from notes payable -- -- 2,086,312
Proceeds from redeemable convertible preferred stock,
net of issuance costs 4,880,435 3,819,506 23,256,599
Proceeds from initial public offering, net of issuance
costs -- 15,297,036 15,297,036
Exercise of stock options 29,066 37,015 78,816
Issuance of convertible preferred stock, net of
issuance costs 4,959,566 -- 7,911,875
----------- ------------ ------------
Net cash provided by financing activities 9,479,446 18,531,875 46,606,862
----------- ------------ ------------
NET INCREASE IN CASH AND EQUIVALENTS $ 1,507,536 $ 12,544,740 $ 16,975,247
CASH AND EQUIVALENTS, BEGINNING OF PERIOD 1,734,188 4,430,507 --
----------- ------------ ------------
CASH AND EQUIVALENTS, END OF PERIOD $ 3,241,724 $ 16,975,247 $ 16,975,247
=========== ============ ============
SUPPLEMENTAL CASH FLOW INFORMATION:
Cash paid during the period for interest $ 156,988 $ 122,384 $ 845,093
=========== ============ ============
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING
AND FINANCING ACTIVITIES:
Property and equipment purchased under capital
lease obligations $ 200,959 $ 298,545 $ 3,022,228
=========== ============ ============
</TABLE>
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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Operations and Basis of Presentation
LeukoSite, Inc. (the "Company") was incorporated on May 1, 1992. The
Company is engaged in the development of proprietary immunomodulatory
therapeutics for the treatment of inflammatory and autoimmune diseases.
The Company is in the development stage and is devoting substantially all
of its efforts toward product research and development and raising capital.
The accompanying unaudited condensed consolidated financial statements have
been prepared by the Company pursuant to the rules and regulations of the
Securities and Exchange Commission and include, in the opinion of
management, all adjustments, consisting of normal, recurring adjustments,
necessary for a fair presentation of interim period results. 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. The Company believes, however, that its disclosures are
adequate to make the information presented not misleading. The results for
the interim periods presented are not necessarily indicative of results to
be expected for the full fiscal year. These financial statements should be
read in conjunction with the financial statements and notes related thereto
included in the Company's Registration Statement on Form S-1 (Registration
No. 333-30213) filed with the Securities and Exchange Commission.
2. Summary of Significant Accounting Policies
(a) Cash Equivalents and Marketable Securities
Cash equivalents are highly liquid investments with original maturities of
less than three months. Marketable securities consist of U.S. government
agency securities with original maturities of greater than three months.
The Company accounts for cash equivalents and marketable securities in
accordance with Statement of Financial Accounting Standards (SFAS) No. 115
"Accounting for Certain Investments in Debt and Equity Securities." In
accordance with SFAS No. 115, the Company has classified its investments as
held-to-maturity. The investments that the Company has the positive intent
and ability to hold to maturity, which consist of cash equivalents and
marketable securities, are reported at amortized cost, which approximates
fair market value.
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As of September 30, 1997, there were no material unrealized gains or losses
on any investments. Cash and cash equivalents and marketable securities
consisted of the following:
<TABLE>
<CAPTION>
December 31, 1996 September 30, 1997
<S> <C> <C>
Cash and Cash Equivalents:
Cash $ 754,473 $ 193,347
Commercial paper -- 5,000,000
----------- -----------
U.S. government agency
obligations -- 7,991,111
----------- -----------
Money market funds 3,676,034 3,790,789
----------- -----------
4,430,507 16,975,247
=========== ===========
Short-term investments:
U.S. government agency
obligations (average
maturity of 5 and 6.3
months, respectively) $ 4,953,902 $ 8,025,631
=========== ===========
</TABLE>
(b) Pro Forma Net Loss per Common Share
Pro forma net loss per common share is based on the pro forma weighted
average number of common shares outstanding during the period, assuming the
automatic conversion of all outstanding shares of redeemable convertible
preferred stock and convertible preferred stock into common stock, which
occurred upon the closing of the Company's initial public offering on
August 15, 1997. Pursuant to the requirements of the Securities and
Exchange Commission Staff Accounting Bulletin No. 83, common and common
equivalent shares issued during the 12 months immediately prior to the date
of the initial filing of the Company's registration statement have been
included in the calculation of weighted average number of common shares
outstanding for the period through the date of the offering using the
treasury method. Other shares of stock issuable pursuant to stock options
have not been included as their effect would be antidilutive.
7
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3. Initial Public Offering
In August 1997, the Company completed the initial public offering of
2,875,000 shares of its common stock at $6 per share, for total net
proceeds of $15.3 million after underwriting discounts and expenses of the
offering. In connection with the public offering, all outstanding shares of
redeemable convertible preferred stock and convertible preferred stock were
automatically converted into 5,535,607 shares of common stock.
4. Investment in Joint Venture
In May 1997, the Company and ILEX Oncology, Inc. entered into a joint
venture whereby the parties formed a limited partnership to develop and
commercialize LDP-03 for the treatment of chronic lymphocytic leukemia. The
partners are required to make contributions each time the partnership
requires working capital. The development and commercialization activities
of the joint venture will be managed with equal control by each party. The
Company and ILEX will generally share equally in profits from the sales of
LDP-03 and in all future research, development, clinical, and
commercialization costs. The Company and ILEX estimate that research,
development, and clinical costs will be approximately $10.0 million over
the next two years.
The Company accounts for its investment in the joint venture under the
equity method of accounting and records its share of the income or loss in
other income (expense). For the three months ended September 30, 1997, the
Company's share of the joint venture's recorded loss was $1,649,400. The
Company funded the joint venture $652,500 through September 30, 1997 and
recorded an obligation of $996,900 at September 30, 1997.
8
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ITEM 2 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS.
FORWARD-LOOKING STATEMENTS - CAUTIONARY STATEMENTS
Certain statements contained in this Quarterly Report on Form 10-Q,
including statements regarding (i) the anticipated development and
expansion of the Company's business expenditures, (ii) the adequacy of the
Company's existing capital resources, interest income and revenue
collaboration to fund the Company's currently planned operating expenses
and capital requirements through early 2000, and (iii) the intent, and
belief and the current expectations of the Company, its directors or its
officers, primarily with respect to the future operating performance of the
Company, and other statements contained herein regarding matters that are
not historical facts, are "forward-looking statements" (as such term is
defined in the Private Securities Litigation Reform Act of 1995). Because
such statements include risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Factors that could cause actual results to differ materially
from those expressed or implied by such forward-looking statements include,
but are not limited to, those discussed under the caption "Risk Factors" in
the Company's Registration Statement on Form S-1 (Registration No.
333-30213) filed by the Company with the Securities and Exchange Commission
and in the last two paragraphs of "Management's Discussion and Analysis of
Financial Condition and Results of Operations-Liquidity and Capital
Resources" elsewhere in this Form 10-Q.
OVERVIEW
The Company is a leader in understanding the biology of leukocytes and
their roles in cancer and inflammatory, autoimmune and viral diseases. The
Company's expertise in leukocyte biology provides an engine for the
discovery and development of novel and proprietary drugs that destroy or
block the disease-causing actions of leukocytes. The Company's funding has
consisted of proceeds from private and public sales of equity securities,
receipts from corporate collaborations and capital leases. The Company has
not received any revenues from the sale of products to date and does not
expect to generate such revenues for at least the next several years. The
Company has experienced operating losses since its inception and expects
that the additional activities required to develop and commercialize its
products will result in further operating losses for at least the next
several years. As of September 30, 1997, the Company had an accumulated
deficit of approximately $28.9 million.
To date, the Company has entered into collaborative agreements with
Warner-Lambert Company ("Warner-Lambert"), Roche Bioscience, and Kyowa
Hakko Kogyo Co. Ltd. ("Kyowa") to discover and develop drugs that inhibit
the action or block the binding of certain chemokines and chemokine
receptors. As of September 30, 1997, the Company had received approximately
$9.4 million in funding and license fee payments under these
collaborations. Under these collaborative agreements, the Company is
entitled to receive additional funding that is not subject to the
achievement of milestones and, if certain drug development milestones are
achieved, milestone payments. In addition, the Company will be entitled to
receive royalties on worldwide sales of products developed and
commercialized from those collaborations. As of September 30, 1997, the
Company had recorded a portion of amounts received from its collaboration
agreements as deferred revenue. In May 1997, the Company and ILEX entered
into a joint venture whereby the parties formed a limited partnership to
develop and commercialize LDP-03 for the treatment of chronic lymphocytic
leukemia.
9
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RESULTS OF OPERATIONS
Revenues for the three and nine month period ended September 30, 1997 and 1996.
For the three months ended September 30, 1997 revenues were $1,610,000
compared to $867,000 for the comparable period in 1996. This increase of
approximately $743,000 was the result of greater research funding from corporate
collaborations with Kyowa, Roche Bioscience, and Warner-Lambert.
For the nine months ended September 30, 1997 revenues were $3,885,000
compared to $1,390,000 for the comparable period in 1996. This increase of
approximately $2,495,000 was the result of greater research funding from
corporate collaborations with Kyowa, Roche Bioscience, and Warner-Lambert and
from Small Business Innovation Research ("SBIR") grants.
Research and development expenses for the three and nine month periods ended
September 30, 1997 and 1996.
For the three months ended September 30, 1997 research and development
expenses were $3,054,000 compared to $2,357,000 for the comparable period in
1996. This increase of approximately $697,000 was primarily due to an increase
in staffing and supplies associated with the Company's drug development
programs. The Company expects research and development spending to increase over
the next several years as the Company further expands its discovery and
development programs.
For the nine months ended September 30, 1997 research and development
expenses were $8,505,000 compared to $6,282,000 for the comparable period in
1996. This increase of approximately $2,223,000 was primarily due to an increase
in staffing and supplies associated with the Company's drug development programs
and, to a lesser extent, to an increase in outside costs associated with
preclinical and development expenditures. The Company expects research and
development spending to increase over the next several years as the Company
further expands its discovery and development programs.
General and administrative expenses for the three and nine month periods ended
September 30, 1997.
For the three months ended September 30, 1997 general and administrative
expenses were $372,000 compared to $372,000 for the comparable period in 1996.
Although general and administrative expenses remained relatively unchanged,
there was an increase in compensation related to additional administrative
staff, which was offset by decreases in legal, and recruiting and relocation
expenses and consulting. General and administrative expenses will likely
increase in future periods to support the projected growth of the Company.
For the nine months ended September 30, 1997 general and administrative
expenses were $1,107,000 compared to $867,000 for the comparable period in 1996.
The increase of approximately $240,000 was primarily due to increases in
compensation related to additional administrative staff and business development
activities, which was offset by a decrease in consulting expense. General and
administrative expenses will likely increase in future periods to support the
projected growth of the Company.
10
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Equity in operations of Joint Venture for the three month and nine month periods
ended September 30, 1997 and 1996.
For the three months ended September 30, 1997 equity in operations of joint
venture was a loss of $1,649,000. These expenses are primarily due to the
manufacture of pilot lots of LDP-03 which will be used to support future planned
regulatory filings. Since this joint venture was not formed until May 1997,
there were no expenses for the comparable three month period in 1996.
For the nine months ended September 30, 1997 equity in operations of joint
venture was a loss of $1,649,000. These expenses are primarily due to the
manufacture of pilot lots of LDP-03 which will be used to support future
planned regulatory filings. Since this joint venture was not formed until May
1997, there were no expenses for the comparable nine month period in 1996.
Interest income (expense), net for the three month and nine month periods ended
September 30, 1997 and 1996.
For the three months ended September 30, 1997 net interest income was
$196,000 compared to $49,000 for the comparable period in 1996. This increase
was primarily due to interest income resulting from higher average cash
balances resulting from proceeds received from LeukoSite's initial public
offering completed in August 1997.
For the nine months ended September 30, 1997 net interest income was
$407,000 compared to $112,000 for the comparable period in 1996. This increase
was primarily due to interest income resulting from higher average cash
balances resulting from proceeds received from LeukoSite's initial public
offering completed in August 1997, and the Company's preferred stock financings
completed in late 1996 and early 1997.
Net Loss for the three month and nine month periods ended September 30, 1997 and
1996.
For the three months ended September 30, 1997 the net loss was $3,269,000
compared to $1,813,000 for the comparable period in 1996. The net loss increased
approximately $1,456,000 and was due primarily to LDP-03 development costs
recorded by the joint venture, which were offset in part by increased revenues
generated from corporate partners.
For the nine months ended September 30, 1997 the net loss was $6,969,000
compared to $5,646,000 for the comparable period in 1996. The net loss increased
approximately $1,323,000 and was due primarily to LDP-03 development costs
recorded by the joint venture, which were offset in part by increased revenues
generated from corporate partners.
11
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LIQUIDITY AND CAPITAL RESOURCES
Since its inception, the Company's operations have been funded primarily
through private placements of preferred stock, which have raised approximately
$33.3 million, license fees and sponsored research, which have generated
approximately $9.5 million, and capital lease obligations, which have raised
approximately $3.0 million, and net proceeds of $15.3 million from the Company's
initial public offering in August 1997. The Company has used cash to fund
operating losses of approximately $28.3 million, the investment of approximately
$2.2 million in equipment and leasehold improvements and the repayment of
approximately $2.0 million of capital lease obligations. The Company had no
significant commitments as of September 30, 1997 for capital expenditures. At
September 30, 1997, the Company had on hand cash, cash equivalents and
marketable securities of approximately $25.0 million.
The Company has entered into sponsored research and consulting agreements
with certain hospitals, academic institutions and consultants, requiring
periodic payments by the Company. Aggregate minimum funding obligations under
these agreements, which include certain cancellation provisions, total
approximately $462,000, which includes funding commitments of approximately
$165,000 and $297,000 in 1997 and 1998, respectively. The Company has also
entered into an agreement to contribute $3.0 million towards funding the
construction and equipping a research center in the United Kingdom. The Company
has paid $1.8 million of the commitment as of September 30, 1997. The additional
commitment of $1.2 million will be funded in semi-annual installments and will
be complete in the year 2000.
In May 1997, the Company and ILEX entered into a joint venture whereby the
parties formed a limited partnership to develop and commercialize LDP-03 for the
treatment of chronic lymphocytic leukemia. The partners are required to make
contributions each time the partnership requires working capital. LeukoSite and
ILEX will generally share equally in profits from the sales of LDP-03 and in
research, development, clinical and commercialization costs. The capital
requirements of the joint venture consists of clinical development and
commercialization costs. LeukoSite and ILEX estimate that research, development,
and clinical costs will be approximately $10.0 million over the next two years.
The Company believes that its existing capital resources (including the
$15.3 million in net proceeds received by the Company in connection with its
initial public offering), interest income and revenue from the collaboration
agreements, will be sufficient to fund its currently planned operating expenses
and capital requirements through early 2000. However, there can be no assurance
that such funds will be sufficient to meet the Company's operating expenses and
capital requirements during such period. The Company's actual cash requirements
may vary materially from those now planned and will depend upon numerous
factors, including the results of the Company's research and development and
collaboration programs, the timing and results of preclinical and clinical
trials, the timing and costs of obtaining regulatory approvals, the progress of
the milestone and royalty producing activities of the Company's collaborative
partners, the level of resources that the Company commits to the development of
manufacturing, marketing, and sales capabilities, the cost of filing,
prosecuting, defending and enforcing patent claims and other intellectual
property rights, the ability of the Company to maintain existing and establish
new collaboration agreements with other companies, the technological advances
and activities of competitors and other factors.
12
<PAGE> 13
The Company expects to incur substantial additional costs, including costs
related to ongoing research and development activities, expenditures for
preclinical and clinical trials and the expansion of its laboratory and
administrative activities. Therefore, the Company will need to raise substantial
additional capital. The Company intends to seek such additional funding through
public or private financing or collaboration or other arrangements with
collaborative partners. There can be no assurance, however, that additional
financing will be available from any sources or, if available, will be available
on acceptable terms.
13
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PART II OTHER INFORMATION
ITEM 2. CHANGES IN SECURITIES
The Company's Registration Statement on Form S-1 (Reg. No.
333-30213) in connection with the Company's initial public offering of
Common Stock was declared effective by the Securities and Exchange
Commission (the "SEC") on August 14, 1997. Such Registration Statement
(the "IPO Registration Statement") provided for the registration under
the Securities Act of 1933, as amended (the "Securities Act"), of
2,875,000 shares of the Company's Common Stock. On August 15, 1997,
the Company entered into an Underwriting Agreement with Hambrecht &
Quist LLC and UBS Securities LLC, as representatives of the several
underwriters named on Schedule A thereto (the "Underwriters"),
pursuant to which (i) the Underwriters agreed to purchase from the
Company 2,500,000 shares of its Common Stock at the public offering
price of $6.00 per share, less underwriting discounts and commissions
of $0.42 per share, and (ii) the Company granted to the Underwriters
an option to purchase an additional 375,000 shares of Common Stock,
solely to cover over-allotments, at the public offering price of $6.00
per share, less underwriting discounts and commissions of $0.42 per
share. On August 20, 1997, the Underwriters consummated the purchase
of such 2,500,000 shares of Common Stock, and on August 26, 1997, the
Underwriters consummated the purchase of such additional 375,000
shares of Common Stock upon exercise of the Underwriters'
over-allotment option.
The aggregate initial public offering price for all 2,875,000
shares of Common Stock registered under the Securities Act pursuant to
the IPO Registration Statement was $ 17,250,000. The aggregate amount
of all expenses (including underwriting discounts and commissions)
paid by the Company in connection with the issuance and distribution
of all such 2,875,000 shares of Common Stock was $1,952,964,
consisting of $1,207,500 paid by the Company to the Underwriters in
respect of underwriting discounts and commissions and $745,464 paid by
the Company in respect of all other expenses incurred by the Company
in connection with such issuance and distribution. All of such
expenses consisted of direct payments to persons or entities, none of
which was a director or officer of the Company, holder of 10 percent
or more of any class of equity securities of the Company or other
affiliate of the Company. The net proceeds to the Company from such
issuance and distribution, after deducting the aggregate amount of
expenses (including underwriting discounts and commissions) paid by
the Company in connection therewith, were $15,297,036.
Of such net proceeds, no amounts have been spent through
September 30, 1997. The remaining balance of such net proceeds,
consisting of $15,297,036 are held in cash or cash equivalents.
14
<PAGE> 15
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
10.1 Amendment to the Research Collaboration and License
Agreement effective April 24, 1997 by and between Kyowa
Hakko Kogyo Co., Ltd. and LeukoSite, Inc.
+10.2 Global Amendment to MCP-1 and IL-8 Agreements between
LeukoSite, Inc. and Warner-Lambert Company
11.1 Computation of Net Loss Per Share
27 Financial Data Schedule
(b) Reports on Form 8-K. No reports on Form 8-K were filed by the
Company during the quarter for which this report is filed.
--------------
+ Confidential Treatment requested as to certain portions.
15
<PAGE> 16
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.
LeukoSite, Inc.
(Registrant)
/s/ Augustine Lawlor
Dated: November 14, 1997 ----------------------------------------
Augustine Lawlor
Vice President, Corporate
Development and Chief Financial Officer
(principal finance and accounting
officer)
16
<PAGE> 1
Exhibit 10.1
AMENDMENT
---------
AMENDMENT dated October 20, 1997, to the Research Collaboration and License
Agreement effective April 24, 1997 by and between Kyowa Hakko Kogyo Co., Ltd., a
Japan corporation ("KHK"), and LeukoSite, Inc., a Delaware corporation ("LKS").
WHEREAS, LKS and KHK are parties to the Research Collaboration and License
Agreement;
WHEREAS, pursuant to certain arrangements between KHK and Warner-Lambert
Company, a Delaware corporation ("W-L"), W-L has certain interests in the
Research Collaboration and License Agreement; and
WHEREAS, W-L has requested that LKS and KHK enter into this Agreement in
order to clarify or modify certain terms of the Research Collaboration and
License Agreement.
NOW THEREFORE, LKS and KHK hereby agree as follows:
1. SECTION 1.22. The definition of "Compound" found in SECTION 1.22 of
the Research Collaboration and License Agreement is hereby modified by deleting
the word "COMPOUND" found therein and replacing it with the phrase "DEVELOPMENT
CANDIDATE".
2. SECTION 2.2 (e). SECTION 2.2 (e) of the Research Collaboration and
License Agreement is hereby deleted in its entirety and replaced by the
following:
"For the avoidance of doubt, in the event of a sublicense by KHK to WL
hereunder, SECTION 2.2(a) and (b) shall be applicable to such
sublicense and such sublicense shall provide for a non-exclusive
license of WL Technology and WL Patents to KHK and/or LKS in the event
of termination of such sublicense, other than a termination by WL for
cause. Such license from WL will be limited to the development and
commercialization of COMPOUNDS in the FIELD. In addition, the
sublicense to WL shall terminate in the event this Agreement
terminates."
3. SECTION 5.6(b). SECTION 5.6(b) of the Research Collaboration and
License Agreement is hereby deleted in its entirety and replaced by the
following:
"KHK will be responsible for all preclinical and clinical development
costs (i) within the KHK TERRITORY and (ii)
<PAGE> 2
during such time as KHK retains licensable rights with regard to
PRODUCTS in the EXTENDED TERRITORY under SECTION 2.2(b), within the
EXTENDED TERRITORY."
4. SECTION 5.9. SECTION 5.9 of the Research Collaboration and License
Agreement is hereby deleted in its entirety and replaced by the following:
"Upon the decision to proceed to GLP toxicology or other safety/PK
studies required for submission of an IND or foreign equivalent in
respect of a COMPOUND, which decision results from the RESEARCH, such
COMPOUND will thereafter be referred to as a "DEVELOPMENT CANDIDATE."
5. SECTION 12.6. SECTION 12.6 of the Research Collaboration and License
Agreement is hereby amended by adding the following proviso to the end thereof:
"PROVIDED, HOWEVER, that this SECTION 12.6 will have no force or
effect from and after the time that royalties would cease to be
payable under SECTION 7.1(b) if this Agreement were to remain in
effect for the full term set forth in such Section."
IN WITNESS WHEREOF, the undersigned have caused this Amendment to be signed
as of the date first written above.
KYOWA HAKKO KOGYO CO., LTD.
By: /s/ SEIGA ITOH
-----------------------------------
Name: Seiga Itoh
Title:
LEUKOSITE, INC.
By: /s/ CHRISTOPHER K. MIRABELLI
-----------------------------------
Name: Christopher K. Mirabelli
Title:
2
<PAGE> 1
EXHIBIT 10.2
GLOBAL AMENDMENT TO MCP-1 AND IL-8 AGREEMENTS
Global Amendment to MCP-1 and IL-8 Agreements dated as of October __, 1997
(this "Global Amendment"), between LEUKOSITE, INC., a Delaware Corporation
("LeukoSite"), and WARNER-LAMBERT COMPANY, a Delaware corporation ("Warner").
WHEREAS, LeukoSite and Warner are parties to the Research, Development
and Marketing Agreement, dated as of September 30, 1994, relating to MCP-1 (as
amended, the "MCP-1 Agreement");
WHEREAS, LeukoSite and Warner are parties to the Research, Development
and Marketing Agreement dated as of July 1, 1995, relating to IL-8 (as amended,
the "IL-8 Agreement"); and
WHEREAS, Warner desires that LeukoSite waive certain co-promotion rights
under the MCP-1 Agreement and IL-8 Agreement, and LeukoSite is willing to waive
such rights pursuant to the terms hereof.
NOW, THEREFORE, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 DEFINITIONS. Capitalized terms used in ARTICLE 2 but not defined
herein will have the meanings ascribed thereto in the MCP-1 Agreement.
Capitalized terms used in ARTICLE 3 but not defined herein will have the
meanings ascribed thereto in the IL-8 Agreement.
ARTICLE 2
MCP-1 AGREEMENT
2.1 SPECIFIC MCP-1 AMENDMENTS. The MCP-1 Agreement is hereby amended as
follows:
<PAGE> 2
Confidential Material Omitted and Filed
Separately with the Securities and Exchange Commission.
Asterisks Denotes Omissions
(a) SECTION 1.7. SECTION 1.7 of the MCP-1 Agreement is hereby
amended by adding the following to the end of such Section:
"Notwithstanding the foregoing, Warner may at any time undertake
research and/or development of MCP-1 inhibitors with Kyowa Hakko
Kogyo Co., Ltd., a Japan corporation ("Kyowa"), and its Affiliates."
(b) SECTION 4.1. The fifth, sixth and seventh sentences of SECTION
4.1 of the MCP-1 Agreement (beginning "Forty-five (45) days after
Warner provides...") are hereby deleted and replaced with the
following: "If Warner exercises marketing rights for a Development
Candidate within the stated period, the Development Candidate shall
become a "Warner Product". The parties acknowledge that although
many references to "Warner-LeukoSite Products" remain in the MCP-1
Agreement, the effect of this SECTION 2.1(b) is to remove the
possibility of a Development Candidate from becoming a
"Warner-LeukoSite Product" and, therefore, unless LeukoSite's
co-promotion rights are reinstated pursuant to SECTION 2.2 of this
Global Amendment such references have no effect.
(c) SECTION 5.3(a). SECTION 5.3(a) of the MCP-1 Agreement is hereby
amended by deleting the phrase "and/or" before the number "(iv)",
and inserting the following immediately before the end of such
Section: ", and/or (v) activities in connection with research,
development, marketing, sale and/or manufacture of compounds with
Kyowa and/or its Affiliates".
(d) SECTION 5.5(c). SECTION 5.5(c) of the MCP-1 Agreement is hereby
amended by adding the following immediately before the end of such
Section: ", and may also take into consideration Warner's
relationships with third parties (such as Kyowa)".
(e) SECTION 5.6(a). SECTION 5.6(a) of the MCP-1 Agreement is hereby
deleted in its entirety and replaced by the following: "For each
Warner Product, Warner will pay LeukoSite ***of worldwide, annual
Net Sales up to **********, *** of worldwide, annual Net Sales
above *********** and up to *********, and *** of worldwide,
annual Net Sales above ***********."
2.2 REINSTATEMENT OF CO-PROMOTION RIGHTS. Warner may at any time, in
its sole discretion, terminate SECTIONS 2.1(b) and 2.1(e) of this Global
Amendment by written notice to LeukoSite. In such event, LeukoSite will have 45
days to designate any Warner Product as a "Warner-LeukoSite Product" by written
notice to Warner. Thereafter, the parties will proceed as follows:
2
<PAGE> 3
(a) REMAIN A WARNER PRODUCT. If LeukoSite does not elect to convert
such Warner Product to a Warner-LeukoSite Product, LeukoSite and
Warner will estimate in good faith the designated share of
Development Costs that LeukoSite would have paid under SECTION 4.2
of the MCP-1 Agreement for the periods set forth in SUBSECTION
5.6(a)(i), (ii), or (iii) of the MCP-1 Agreement. Before the end of
the 45 day period, LeukoSite will pay Warner the Development Costs
referred to in SUBSECTION 5.6(a)(i), (ii), or (iii), and thereafter
LeukoSite will be entitled to receive the royalty rates referred to
in such Subsection. If Warner terminates SECTION 2.1(b) and 2.1(e)
of this Global Amendment prior to completion of all Phase II
clinical studies reasonably deemed necessary by the Management
Committee for regulatory approval to market the Product in the
United States of America, LeukoSite may elect to pay the designated
share of Development Costs that LeukoSite would have paid under
SECTION 4.2 of the MCP-1 Agreement up to and including the time that
Warner terminates such SECTION 2.1(b) and 2.1(e), and thereafter
LeukoSite may continue to pay its designated share of Development
Costs as they become due in order to preserve its rights to a
greater royalty under SECTION 5.6(a) of the MCP-1 Agreement.
(b) CONVERT TO A WARNER-LEUKOSITE PRODUCT. If LeukoSite does elect
to convert such Warner Product to a Warner-LeukoSite Product,
LeukoSite and Warner will estimate in good faith the designated
share of Development Costs that LeukoSite would have paid under
SECTION 4.2 of the MCP-1 Agreement up to and including the earlier
of (i) the time of such election and (ii) NDA approval in the United
States. Thereafter, if such election occurs prior to such NDA
approval, LeukoSite will continue to pay its designated share of
Development Costs as they become due up to and including such NDA
approval in order to keep such Warner-LeukoSite Product from
reverting to a Warner Product.
ARTICLE 3
IL-8 AGREEMENT
3.1 SPECIFIC IL-8 AMENDMENTS. The IL-8 Agreement is hereby amended as
follows:
(a) SECTION 1.7. SECTION 1.7 of the IL-8 Agreement is hereby
amended by adding the following to the end of such Section:
"Notwithstanding the foregoing, Warner may at any time undertake
research and/or development of IL-8 Inhibitors with Kyowa Hakko
Kogyo Co., Ltd., a Japan corporation ("Kyowa"), and its Affiliates."
3
<PAGE> 4
Confidential Material Omitted and Filed
Separately with the Securities and Exchange Commission.
Asterisks Denotes Omissions
(b) SECTION 4.1. The fifth, sixth and seventh sentences of SECTION
4.1 of the IL-8 Agreement (beginning "Forty-five (45) days after
Warner provides...") are hereby deleted and replaced with the
following: "If Warner exercises marketing rights for a Development
Candidate within the stated period, the Development Candidate shall
become a "Warner Product". The parties acknowledge that although
many references to "Warner-LeukoSite Products" remain in the IL-8
Agreement, the effect of this SECTION 3.1(b) is to remove the
possibility of a Development Candidate from becoming a
"Warner-LeukoSite Product" and, therefore, unless LeukoSite's
co-promotion rights are reinstated pursuant to SECTION 3.2 of this
Global Amendment such references have no effect.
(c) SECTION 5.3(a). SECTION 5.3(a) of the IL-8 Agreement is hereby
amended by deleting the Phrase "and/or" before the number "(iv)",
and inserting the following immediately before the end of such
Section: ", and/or (v) activities in connection with research,
development, marketing, sale and/or manufacture of compounds with
Kyowa and/or its Affiliates".
(d) SECTION 5.5(c). SECTION 5.5(c) of the IL-8 Agreement is hereby
amended by adding the following immediately before the end of such
Section: ", and may also take into consideration Warner's
relationships with third parties (such as Kyowa)".
(e) SECTION 5.6(a). SECTION 5.6(a) of the IL-8 Agreement is hereby
deleted in its entirety and replaced by the following: "For each
Warner Product, Warner will pay LeukoSite ** of worldwide, annual
Net Sales up to *********, *** of worldwide, annual Net Sales
above ********** and up to **********, and **** of worldwide,
annual Net Sales above *********."
3.2 REINSTATEMENT OF CO-PROMOTION RIGHTS. Warner may at any time, in
its sole discretion, terminate SECTIONS 3.1(b) and 3.1(e) of this Global
Amendment by written notice to LeukoSite. In such event, LeukoSite will have 45
days to designate any Warner Product as a "Warner-LeukoSite Product" by written
notice to Warner. Thereafter, the parties will proceed as follows:
(a) REMAIN A WARNER PRODUCT. If LeukoSite does not elect to convert
such Warner Product to a Warner-LeukoSite Product, LeukoSite and
Warner will estimate in good faith the designated share of
Development Costs that LeukoSite would have paid under SECTION 4.2
of the IL-8 Agreement for the periods set forth in SUBSECTION
5.6(a)(i), (ii), or (iii) of the IL-8 Agreement. Before the end of
the 45 day period, LeukoSite will pay Warner the Development Costs
referred to in SUBSECTION 5.6(a)(i), (ii), or (iii), and thereafter
LeukoSite will be entitled to receive the royalty rates referred to
in such Subsection. If Warner terminates SECTION 3.1(b) and 3.1(e)
of this Global Amendment prior to completion of all Phase II
4
<PAGE> 5
clinical studies reasonably deemed necessary by the Management
Committee for regulatory approval to market the Product in the
United States of America, LeukoSite may elect to pay the designated
share of Development Costs that LeukoSite would have paid under
SECTION 4.2 of the IL-8 Agreement up to and including the time that
Warner terminates such SECTIONS 3.1(b) and 3.1(e), and thereafter
LeukoSite may continue to pay its designated share of Development
Costs as they become due in order to preserve its rights to a great
royalty under SECTION 5.6(a) of the IL-8 Agreement.
(b) CONVERT TO WARNER-LEUKOSITE PRODUCT. If LeukoSite does elect to
convert such Warner Product to a Warner-LeukoSite Product, LeukoSite
and Warner will estimate in good faith the designated share of
Development Costs that LeukoSite would have paid under SECTION 4.2
of the IL-8 Agreement up to and including the earlier of (i) the
time of such election and (ii) NDA approval in the United States.
Thereafter, if such election occurs prior to such NDA approval,
LeukoSite will continue to pay its designated share of Development
Costs as they become due up to and including such NDA approval in
order to keep such Warner-LeukoSite Product from reverting to a
Warner Product.
ARTICLE 4
GOVERNING LAW
4.1 GOVERNING LAW. This Global Amendment shall be construed and
interpreted in accordance with the laws of the Commonwealth of Massachusetts,
other than those provisions governing conflicts of law.
ARTICLE 5
HEADINGS
5.1 HEADINGS. The headings appearing herein have been inserted solely
for the convenience of the parties hereto and shall not affect the construction,
meaning or interpretation of this Global Amendment or any of its terms and
conditions.
5
<PAGE> 6
ARTICLE 6
COUNTERPARTS
6.1 COUNTERPARTS. This Global Amendment may be executed in counterparts,
each of which shall be deemed an original and both of which together shall
constitute one and the same instrument.
IN WITNESS WHEREOF, the parties hereto have caused this Global Amendment
to be signed by their duly authorized officers as of the date first above
written.
LEUKOSITE, INC. WARNER-LAMBERT COMPANY
By: /s/ CHRISTOPHER K. MIRABELLI By: /s/ WENDELL WIERENGA
------------------------------ ------------------------------
Name: Christopher K. Mirabelli Name: Wendell Wierenga
Title: Title:
6
<PAGE> 1
EXHIBIT 11.1
LEUKOSITE, INC.
COMPUTATION OF PRO FORMA NET LOSS PER COMMON SHARE
<TABLE>
<CAPTION>
THREE MONTHS ENDED SEPTEMBER. 30, NINE MONTHS ENDED SEPTEMBER 30,
1996 1997 1996 1997
----------- ----------- ----------- -----------
<S> <C> <C> <C> <C>
Net Loss $(1,812,679) $(3,269,215) $(5,646,099) $(6,969,331)
=========== =========== =========== ============
Shares used in computing pro forma net loss per
common share:
Weighted average common stock outstanding
during the period 1,074,990 2,550,668 1,059,566 1,584,277
Conversion of redeemable convertible
preferred stock and convertible preferred
stock (1) 4,830,498 5,535,632 4,830,498 5,535,632
Dilutive effect of common equivalent shares
issued subsequent to June 26, 1996 (2) 142 71 142 47
----------- ----------- ----------- -----------
5,905,630 8,086,371 5,890,206 7,119,956
=========== =========== =========== ===========
Pro forma net loss per common share $ (.31) $ (.40) $ (.96) $ (.98)
=========== =========== =========== ===========
</TABLE>
(1) Effective upon the closing of the Company's initial public offering of
common stock, all shares of redeemable convertible preferred stock and
convertible preferred stock automatically converted into common stock.
Accordingly, these shares have been included as outstanding for all periods
presented.
(2) Pursuant to Securities and Exchange Commission Staff Accounting Bulletin No.
83, common stock, preferred stock, stock options and warrants issued at prices
below the initial public offering price per share ("cheap stock") during the
twelve month period immediately preceding the filing date of the Company's
Registration Statement for its initial public offering have been included as
outstanding for all periods through the date of the offering. The dilutive
effect of the common and common stock equivalents was computed in accordance
with the treasury stock method.
<TABLE> <S> <C>
<ARTICLE> 5
<MULTIPLIER> 1,000
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> SEP-30-1997
<CASH> 16,975
<SECURITIES> 8,026
<RECEIVABLES> 0
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 25,298
<PP&E> 4,994
<DEPRECIATION> 2,840
<TOTAL-ASSETS> 27,480
<CURRENT-LIABILITIES> 6,143
<BONDS> 0
0
0
<COMMON> 95
<OTHER-SE> 20,421
<TOTAL-LIABILITY-AND-EQUITY> 27,480
<SALES> 0
<TOTAL-REVENUES> 3,885
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 9,613
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 122
<INCOME-PRETAX> 0
<INCOME-TAX> 0
<INCOME-CONTINUING> (5,727)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (6,969)
<EPS-PRIMARY> (.98)
<EPS-DILUTED> 0
</TABLE>
