<PAGE> 1
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (D) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE PERIOD ENDED NOVEMBER 30, 2000
OR
[ ] TRANSITION REPORT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT OF 1934
FOR THE TRANSITION PERIOD FROM TO
----------- ------------
COMMISSION FILE NUMBER 0-24050
NORTHFIELD LABORATORIES INC.
(Exact name of registrant as specified in its charter)
DELAWARE 36-3378733
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
1560 SHERMAN AVENUE, SUITE 1000, EVANSTON, ILLINOIS 60201-4800
(Address of principal executive offices) (Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (847) 864-3500
FORMER NAME, FORMER ADDRESS AND FORMER FISCAL YEAR, IF CHANGED SINCE LAST
REPORT: NOT APPLICABLE
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
--- ---
APPLICABLE ONLY TO ISSUER INVOLVED IN BANKRUPTCY
PROCEEDINGS DURING THE PRECEDING FIVE YEARS:
INDICATE BY CHECK MARK WHETHER THE REGISTRANT HAS FILED ALL DOCUMENTS
AND REPORTS REQUIRED TO BE FILED BY SECTION 12, 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934 SUBSEQUENT TO THE DISTRIBUTION OF SECURITIES UNDER A PLAN
CONFIRMED BY A COURT. YES NO
--- ---
AS OF NOVEMBER 30, 2000, REGISTRANT HAD 14,242,375 SHARES OF COMMON STOCK
OUTSTANDING
================================================================================
<PAGE> 2
Part I. Financial Information
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Financial Statements
November 30, 2000
(See accompanying Review Report of KPMG LLP)
<PAGE> 3
INDEPENDENT ACCOUNTANTS' REVIEW REPORT
The Board of Directors
Northfield Laboratories Inc.:
We have reviewed the balance sheet of Northfield Laboratories Inc. (a company in
the development stage) as of November 30, 2000, and the related statements of
operations for the three-month period ended November 30, 2000 and 1999, and
statements of operations and cash flows for the six-month periods ended November
30, 2000 and 1999 and for the period from June 19, 1985 (inception) through
November 30, 2000. We have also reviewed the statements of shareholders' equity
(deficit) for the six-month period ended November 30, 2000 and for the period
from June 19, 1985 (inception) through November 30, 2000. These financial
statements are the responsibility of the Company's management.
We conducted our review in accordance with standards established by the American
Institute of Certified Public Accountants. A review of interim financial
information consists principally of applying analytical procedures to financial
data and making inquiries of persons responsible for financial and accounting
matters. It is substantially less in scope than an audit conducted in accordance
with auditing standards generally accepted in the United States of America, the
objective of which is the expression of an opinion regarding the financial
statements taken as a whole. Accordingly, we do not express such an opinion.
Based on our review, we are not aware of any material modifications that should
be made to the financial statements referred to above for them to be in
conformity with accounting principles generally accepted in the United States of
America.
We have previously audited, in accordance with auditing standards generally
accepted in the United States of America, the balance sheet of Northfield
Laboratories Inc. as of May 31, 2000, and the related statements of operations,
shareholders' equity (deficit), and cash flows for the year then ended and for
the period from June 19, 1985 (inception) through May 31, 2000 (not presented
herein); and in our report dated June 29, 2000, we expressed an unqualified
opinion on those financial statements. In our opinion, the information set forth
in the accompanying balance sheet as of May 31, 2000 and in the accompanying
statement of shareholders' equity (deficit) is fairly stated, in all material
respects, in relation to the statement from which it has been derived.
/s/ KPMG LLP
December 13, 2000
<PAGE> 4
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
November 30, 2000 (unaudited) and May 31, 2000
<TABLE>
<CAPTION>
NOVEMBER 30, MAY 31,
Assets 2000 2000
------------- ---------------
<S> <C> <C>
Current assets:
Cash $ 9,558,775 15,154,295
Short-term marketable securities 23,771,046 23,129,324
Prepaid expenses 273,276 409,270
Other current assets 532,291 505,572
------------- -------------
Total current assets 34,135,388 39,198,461
Property, plant, and equipment, net 2,808,929 2,455,701
Other assets 123,028 74,333
------------- -------------
$ 37,067,345 41,728,495
============= =============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,214,458 1,061,367
Accrued expenses 91,408 174,009
Accrued compensation and benefits 267,172 250,570
------------- -------------
Total current liabilities 1,573,038 1,485,946
Other liabilities 160,726 147,717
------------- -------------
Total liabilities 1,733,764 1,633,663
------------- -------------
Shareholders' equity:
Preferred stock, $.01 par value. Authorized 5,000,000 shares;
none issued and outstanding -- --
Common stock, $.01 par value. Authorized 30,000,000 shares;
issued and outstanding 14,242,375 shares
at November 30, 2000 and May 31, 2000, respectively 142,424 142,424
Additional paid-in capital 117,276,051 117,276,051
Deficit accumulated during the development stage (82,084,894) (77,323,643)
------------- -------------
Total shareholders' equity 35,333,581 40,094,832
------------- -------------
$ 37,067,345 41,728,495
============= =============
</TABLE>
See accompanying independent accountants' review report.
<PAGE> 5
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three and six months ended November 30, 2000 and 1999 and for the
period from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
CUMULATIVE
THREE MONTHS ENDED SIX MONTHS ENDED FROM
NOVEMBER 30, NOVEMBER 30, JUNE 19, 1985
------------------------ ------------------------ THROUGH
2000 1999 2000 1999 NOVEMBER 30, 2000
----------- ----------- ----------- ----------- -----------------
(UNAUDITED) (UNAUDITED) (UNAUDITED) (UNAUDITED) (UNAUDITED)
<S> <C> <C> <C> <C> <C>
Revenues - license income $ -- -- -- -- 3,000,000
Costs and expenses:
Research and development 2,237,122 2,362,427 4,474,704 4,486,630 73,615,117
General and administrative 557,627 523,505 1,427,503 1,008,305 32,898,716
----------- ----------- ----------- ----------- -----------------
2,794,749 2,885,932 5,902,207 5,494,935 106,513,833
----------- ----------- ----------- ----------- -----------------
Other income and expense:
Interest income 551,418 579,291 1,140,956 1,149,153 21,512,173
Interest expense -- -- -- -- (83,234)
----------- ----------- ----------- ----------- -----------------
551,418 579,291 1,140,956 1,149,153 21,428,939
----------- ----------- ----------- ----------- -----------------
Net loss $ (2,243,331) (2,306,641) (4,761,251) (4,345,782) (82,084,894)
=========== =========== =========== =========== =================
Net loss per basic share $ (0.16) (0.16) (0.33) (0.31) (8.98)
=========== =========== =========== =========== =================
Shares used in calculation of per share data 14,242,375 14,239,875 14,242,375 14,239,875 9,142,816
=========== =========== =========== =========== =================
</TABLE>
See accompanying independent accountants' review report.
<PAGE> 6
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit)
Three and six months ended November 30, 2000 and 1999 and for the
period from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
Preferred stock Common stock
---------------------- --------------------
Number Aggregate Number Aggregate
of shares amount of shares amount
--------- ----------- ---------- ---------
<S> <C> <C> <C> <C>
Issuance of common stock on August 27, 1985 -- $ -- 3,500,000 $ 35,000
Issuance of Series A convertible preferred stock at $4.00 per share on
August 27, 1985 (net of costs of issuance of $79,150) -- -- -- --
Net loss -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1986 -- -- 3,500,000 35,000
Net loss -- -- -- --
Deferred compensation relating to grant of stock options -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1987 -- -- 3,500,000 35,000
Issuance of Series B convertible preferred stock at $35.68 per share on
August 14, 1987 (net of costs of issuance of $75,450) -- -- -- --
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1988 -- -- 3,500,000 35,000
Issuance of common stock at $24.21 per share on June 7, 1988 (net of costs of
issuance of $246,000) -- -- 413,020 4,130
Conversion of Series A convertible preferred stock to common stock on June 7, 1988 -- -- 1,250,000 12,500
Conversion of Series B convertible preferred stock to common stock on June 7, 1988 -- -- 1,003,165 10,032
Exercise of stock options at $2.00 per share -- -- 47,115 471
Issuance of common stock at $28.49 per share on March 6, 1989 (net of costs of
issuance of $21,395) -- -- 175,525 1,755
Issuance of common stock at $28.49 per share on March 30, 1989 (net of costs of
issuance of $10,697) -- -- 87,760 878
Sale of options at $28.29 per share to purchase common stock at $.20 per share on
March 30, 1989 (net of costs of issuance of $4,162) -- -- -- --
Net loss -- -- -- --
Deferred compensation relating to grant of stock options -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1989 -- -- 6,476,585 64,766
Net loss -- -- -- --
Deferred compensation relating to grant of stock options -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1990 -- -- 6,476,585 64,766
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1991 -- -- 6,476,585 64,766
Exercise of stock warrants at $5.60 per share -- -- 90,000 900
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1992 -- -- 6,566,585 65,666
Exercise of stock warrants at $7.14 per share -- -- 15,000 150
Issuance of common stock at $15.19 per share on April 19, 1993 (net of costs of
issuance of $20,724) -- -- 374,370 3,744
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- ----------- ---------- ---------
Balance at May 31, 1993 -- -- 6,955,955 69,560
--------- ----------- ---------- ---------
</TABLE>
See accompanying independent accountants' review report.
<PAGE> 7
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit) (continued)
Six months ended November 30, 2000 and for the
period from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
Series A convertible Series B convertible
preferred stock preferred stock
-------------------- ---------------------
Number Aggregate Number Aggregate
of shares amount of shares amount
-------------------- ---------------------
<S> <C> <C> <C> <C>
Issuance of common stock on August 27, 1985 -- $ -- -- $ --
Issuance of Series A convertible preferred stock at $4.00 per share on
August 27, 1985 (net of costs of issuance of $79,150) 250,000 250,000 -- --
Net loss -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1986 250,000 250,000 -- --
Net loss -- -- -- --
Deferred compensation relating to grant of stock options -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1987 250,000 250,000 -- --
Issuance of Series B convertible preferred stock at $35.68 per share on
August 14, 1987 (net of costs of issuance of $75,450) -- -- 200,633 200,633
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1988 250,000 250,000 200,633 200,633
Issuance of common stock at $24.21 per share on June 7, 1988 (net of costs of
issuance of $246,000) -- -- -- --
Conversion of Series A convertible preferred stock to common stock on June 7, 1988 (250,000) (250,000) -- --
Conversion of Series B convertible preferred stock to common stock on June 7, 1988 -- -- (200,633) (200,633)
Exercise of stock options at $2.00 per share -- -- -- --
Issuance of common stock at $28.49 per share on March 6, 1989 (net of costs of
issuance of $21,395) -- -- -- --
Issuance of common stock at $28.49 per share on March 30, 1989 (net of costs of
issuance of $10,697) -- -- -- --
Sale of options at $28.29 per share to purchase common stock at $.20 per share on
March 30, 1989 (net of costs of issuance of $4,162) -- -- -- --
Net loss -- -- -- --
Deferred compensation relating to grant of stock options -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1989 -- -- -- --
Net loss -- -- -- --
Deferred compensation relating to grant of stock options -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1990 -- -- -- --
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1991 -- -- -- --
Exercise of stock warrants at $5.60 per share -- -- -- --
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1992 -- -- -- --
Exercise of stock warrants at $7.14 per share -- -- -- --
Issuance of common stock at $15.19 per share on April 19, 1993 (net of costs of
issuance of $20,724) -- -- -- --
Net loss -- -- -- --
Amortization of deferred compensation -- -- -- --
--------- --------- ---------- ---------
Balance at May 31, 1993 -- -- -- --
--------- --------- ---------- ---------
</TABLE>
(Continued)
<PAGE> 8
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit) (continued)
Six months ended November 30, 2000 and for the
period from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
Deficit Total
accumulated share-
Additional during the Deferred holders'
paid-in development compen- equity
capital stage sation (deficit)
----------- ----------- ---------- -----------
<S> <C> <C> <C> <C>
Issuance of common stock on August 27, 1985 (28,000) -- -- 7,000
Issuance of Series A convertible preferred stock at $4.00 per share on
August 27, 1985 (net of costs of issuance of $79,150) 670,850 -- -- 920,850
Net loss -- (607,688) -- (607,688)
---------- ----------- ---------- ----------
Balance at May 31, 1986 642,850 (607,688) -- 320,162
Net loss -- (2,429,953) -- (2,429,953)
Deferred compensation relating to grant of stock options 2,340,000 -- (2,340,000) --
Amortization of deferred compensation -- -- 720,000 720,000
---------- ----------- ---------- ----------
Balance at May 31, 1987 2,982,850 (3,037,641) (1,620,000) (1,389,791)
Issuance of Series B convertible preferred stock at $35.68 per share on
August 14, 1987 (net of costs of issuance of $75,450) 6,882,502 -- -- 7,083,135
Net loss -- (3,057,254) -- (3,057,254)
Amortization of deferred compensation -- -- 566,136 566,136
---------- ----------- ---------- ----------
Balance at May 31, 1988 9,865,352 (6,094,895) (1,053,864) 3,202,226
Issuance of common stock at $24.21 per share on June 7, 1988 (net of costs of
issuance of $246,000) 9,749,870 -- -- 9,754,000
Conversion of Series A convertible preferred stock to common stock on June 7, 1988 237,500 -- -- --
Conversion of Series B convertible preferred stock to common stock on June 7, 1988 190,601 -- -- --
Exercise of stock options at $2.00 per share 93,759 -- -- 94,230
Issuance of common stock at $28.49 per share on March 6, 1989 (net of costs of
issuance of $21,395) 4,976,855 -- -- 4,978,610
Issuance of common stock at $28.49 per share on March 30, 1989 (net of costs of
issuance of $10,697) 2,488,356 -- -- 2,489,234
Sale of options at $28.29 per share to purchase common stock at $.20 per share on
March 30, 1989 (net of costs of issuance of $4,162) 7,443,118 -- -- 7,443,118
Net loss -- (791,206) -- (791,206)
Deferred compensation relating to grant of stock options 683,040 -- (683,040) --
Amortization of deferred compensation -- -- 800,729 800,729
---------- ----------- ---------- ----------
Balance at May 31, 1989 35,728,451 (6,886,101) (936,175) 27,970,941
Net loss -- (3,490,394) -- (3,490,394)
Deferred compensation relating to grant of stock options 699,163 -- (699,163) --
Amortization of deferred compensation -- -- 546,278 546,278
---------- ----------- ---------- ----------
Balance at May 31, 1990 36,427,614 (10,376,495) (1,089,060) 25,026,825
Net loss -- (5,579,872) -- (5,579,872)
Amortization of deferred compensation -- -- 435,296 435,296
---------- ----------- ---------- ----------
Balance at May 31, 1991 36,427,614 (15,956,367) (653,764) 19,882,249
Exercise of stock warrants at $5.60 per share 503,100 -- -- 504,000
Net loss -- (7,006,495) -- (7,006,495)
Amortization of deferred compensation -- -- 254,025 254,025
---------- ----------- ---------- ----------
Balance at May 31, 1992 36,930,714 (22,962,862) (399,739) 13,633,779
Exercise of stock warrants at $7.14 per share 106,890 -- -- 107,040
Issuance of common stock at $15.19 per share on April 19, 1993 (net of costs of
issuance of $20,724) 5,663,710 -- -- 5,667,454
Net loss -- (8,066,609) -- (8,066,609)
Amortization of deferred compensation -- -- 254,025 254,025
---------- ----------- ---------- ----------
Balance at May 31, 1993 42,701,314 (31,029,471) (145,714) 11,595,689
---------- ----------- ---------- ----------
</TABLE>
(Continued)
<PAGE> 9
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit) (continued)
Six months ended November 30, 2000 and for the
period from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
SERIES A CONVERTIBLE
PREFERRED STOCK COMMON STOCK PREFERRED STOCK
--------------------- ---------------------- --------------------
NUMBER AGGREGATE NUMBER AGGREGATE NUMBER AGGREGATE
OF SHARES AMOUNT OF SHARES AMOUNT OF SHARES AMOUNT
--------- ---------- ----------- ---------- --------- --------
<S> <C> <C> <C> <C> <C> <C>
Net loss -- $ -- -- $ -- -- $ --
Issuance of common stock at $6.50 per share on
May 26, 1994 (net of costs of issuance of $2,061,149) -- -- 2,500,000 25,000 -- --
Cancellation of stock options -- -- -- -- -- --
Amortization of deferred compensation -- -- -- -- -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 1994 -- -- 9,455,955 94,560 -- --
Net loss -- -- -- -- -- --
Issuance of common stock at $6.50 per share on
June 20, 1994 (net of issuance costs of $172,500) -- -- 375,000 3,750 -- --
Exercise of stock options at $7.14 per share -- -- 10,000 100 -- --
Exercise of stock options at $2.00 per share -- -- 187,570 1,875 -- --
Cancellation of stock options -- -- -- -- -- --
Amortization of deferred compensation -- -- -- -- -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 1995 -- -- 10,028,525 100,285 -- --
Net loss -- -- -- -- -- --
Issuance of common stock at $17.75 per share on
August 9, 1995 (net of issuance costs of $3,565,125) -- -- 2,925,000 29,250 -- --
Issuance of common stock at $17.75 per share on
September 11, 1995 (net of issuance costs of $423,23) -- -- 438,750 4,388 -- --
Exercise of stock options at $2.00 per share -- -- 182,380 1,824 -- --
Exercise of stock options at $6.38 per share -- -- 1,500 15 -- --
Exercise of stock options at $7.14 per share -- -- 10,000 100 -- --
Cancellation of stock options -- -- -- -- -- --
Amortization of deferred compensation -- -- -- -- -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 1996 -- -- 13,586,155 135,862 -- --
Net loss -- -- -- -- -- --
Exercise of stock options at $0.20 per share -- -- 263,285 2,633 -- --
Exercise of stock options at $2.00 per share -- -- 232,935 2,329 -- --
Exercise of stock options at $7.14 per share -- -- 10,000 100 -- --
Amortization of deferred compensation -- -- -- -- -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 1997 -- -- 14,092,375 140,924 -- --
Net loss -- -- -- -- -- --
Exercise of stock options at $7.14 per share -- -- 5,000 50 -- --
Amortization of deferred compensation -- -- -- -- -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 1998 -- -- 14,097,375 140,974 -- --
Net loss -- -- -- -- -- --
Non-cash compensation -- -- -- -- -- --
Exercise of stock options at $7.14 per share -- -- 17,500 175 -- --
Exercise of stock warrants at $8.00 per share -- -- 125,000 1,250 -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 1999 -- -- 14,239,875 142,399 -- --
Net loss -- -- -- -- -- --
Non-cash compensation -- -- -- -- -- --
Exercise of stock options at $13.38 per share -- -- 2,500 25 -- --
--------- ---------- ----------- --------- --------- --------
Balance at May 31, 2000 -- -- 14,242,375 142,424 -- --
Net loss (unaudited) -- -- -- -- -- --
--------- ---------- ----------- --------- --------- --------
Balance at November 30, 2000 (unaudited) -- $ -- 14,242,375 $ 142,424 -- $ --
========= ========== =========== ========= ========= ========
</TABLE>
See accompanying independent accountants' review report.
(Continued)
<PAGE> 10
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit) (continued)
Six months ended November 30, 2000 and for the
period from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
SERIES B CONVERTIBLE DEFICIT TOTAL
PREFERRED STOCK ACCUMULATED SHARE-
-------------------- ADDITIONAL DURING THE DEFERRED HOLDERS'
NUMBER AGGREGATE PAID-IN DEVELOPMENT COMPEN- EQUITY
OF SHARES AMOUNT CAPITAL STAGE SATION (DEFICIT)
----------- --------- ----------- ----------- ---------- -----------
<S> <C> <C> <C> <C> <C> <C>
Net loss -- $ -- -- (7,363,810) -- (7,363,810)
Issuance of common stock at $6.50 per share on
May 26, 1994 (net of costs of issuance of $2,061,149) -- -- 14,163,851 -- -- 14,188,851
Cancellation of stock options -- -- (85,400) -- 85,400 --
Amortization of deferred compensation -- -- -- -- 267 267
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 1994 -- -- 56,779,765 (38,393,281) (60,047) 18,420,997
Net loss -- -- -- (7,439,013) -- (7,439,013)
Issuance of common stock at $6.50 per share on
June 20, 1994 (net of issuance costs of $172,500) -- -- 2,261,250 -- -- 2,265,000
Exercise of stock options at $7.14 per share -- -- 71,300 -- -- 71,400
Exercise of stock options at $2.00 per share -- -- 373,264 -- -- 375,139
Cancellation of stock options -- -- (106,750) -- 106,750 --
Amortization of deferred compensation -- -- -- -- (67,892) (67,892)
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 1995 -- -- 59,378,829 (45,832,294) (21,189) 13,625,631
Net loss -- -- -- (4,778,875) -- (4,778,875)
Issuance of common stock at $17.75 per share on
August 9, 1995 (net of issuance costs of $3,565,125) -- -- 48,324,374 -- -- 48,353,624
Issuance of common stock at $17.75 per share on
September 11, 1995 (net of issuance costs of $423,23) -- -- 7,360,187 -- -- 7,364,575
Exercise of stock options at $2.00 per share -- -- 362,937 -- -- 364,761
Exercise of stock options at $6.38 per share -- -- 9,555 -- -- 9,570
Exercise of stock options at $7.14 per share -- -- 71,300 -- -- 71,400
Cancellation of stock options -- -- (80,062) -- 80,062 --
Amortization of deferred compensation -- -- -- -- (62,726) (62,726)
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 1996 -- -- 115,427,120 (50,611,169) (3,853) 64,947,960
Net loss -- -- -- (4,245,693) -- (4,245,693)
Exercise of stock options at $0.20 per share -- -- 50,025 -- -- 52,658
Exercise of stock options at $2.00 per share -- -- 463,540 -- -- 465,869
Exercise of stock options at $7.14 per share -- -- 71,300 -- -- 71,400
Amortization of deferred compensation -- -- -- -- 2,569 2,569
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 1997 -- -- 116,011,985 (54,856,862) (1,284) 61,294,763
Net loss -- -- -- (5,883,378) -- (5,883,378)
Exercise of stock options at $7.14 per share -- -- 35,650 -- -- 35,700
Amortization of deferred compensation -- -- -- -- 1,284 1,284
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 1998 -- -- 116,047,635 (60,740,240) -- 55,448,369
Net loss -- -- -- (7,416,333) -- (7,416,333)
Non-cash compensation -- -- 14,354 -- -- 14,354
Exercise of stock options at $7.14 per share -- -- 124,775 -- -- 124,950
Exercise of stock warrants at $8.00 per share -- -- 998,750 -- -- 1,000,000
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 1999 -- -- 117,185,514 (68,156,573) -- 49,171,340
Net loss -- -- -- (9,167,070) -- (9,167,070)
Non-cash compensation -- -- 57,112 -- -- 57,112
Exercise of stock options at $13.38 per share -- -- 33,425 -- -- 33,450
---------- --------- ----------- ----------- ---------- -----------
Balance at May 31, 2000 -- -- 117,276,051 (77,323,643) -- 40,094,832
Net loss (unaudited) -- -- -- (4,761,251) -- (4,761,251)
---------- --------- ----------- ----------- ---------- -----------
Balance at November 30, 2000 (unaudited) -- $ -- 117,276,051 (82,084,894) -- 35,333,581
========== ========= =========== =========== ========== ===========
</TABLE>
(Continued)
<PAGE> 11
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Cash Flows
Six months ended November 30, 2000 and 1999 and for the period
from June 19, 1985 (inception) through November 30, 2000
<TABLE>
<CAPTION>
CUMULATIVE
SIX MONTHS ENDED FROM
NOVEMBER 30, JUNE 19, 1985
--------------------------- THROUGH
2000 1999 NOVEMBER 30, 2000
------------ ------------- --------------------
(UNAUDITED) (UNAUDITED) (UNAUDITED)
<S> <C> <C> <C>
Cash flows from operating activities:
Net loss $(4,761,251) (4,345,782) (82,084,894)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 247,005 195,277 14,895,634
Non-cash compensation -- 74,328 3,552,723
Loss on sale of equipment -- -- 66,359
Changes in assets and liabilities:
Prepaid expenses 135,994 115,978 (482,487)
Other current assets (26,719) (185,584) (2,428,542)
Other assets (49,200) -- (42,247)
Accounts payable 153,091 283,935 1,214,458
Accrued expenses (82,601) (36,298) 91,408
Accrued compensation and benefits 16,602 34,404 267,172
Other liabilities 13,009 10,006 160,726
------------ ------------- -------------------
Net cash used in operating activities (4,354,070) (3,853,736) (64,789,690)
------------ ------------- -------------------
Cash flows from investing activities:
Purchase of property, plant, equipment,
and capitalized engineering costs (599,728) (1,532,874) (17,640,530)
Proceeds from matured marketable securities 5,774,561 3,549,200 361,164,542
Proceeds from sale of marketable securities -- -- 7,141,656
Purchase of marketable securities (6,416,283) (4,954,654) (392,077,245)
Proceeds from sale of equipment -- 1,786,436 1,863,023
------------ ------------- --------------------
Net cash used in investing activities (1,241,450) (1,151,892) (39,548,554)
------------ ------------- --------------------
Cash flows from financing activities:
Proceeds from issuance of common stock -- -- 103,521,928
Payment of common stock issuance costs -- -- (5,072,012)
Proceeds from issuance of preferred stock -- -- 6,644,953
Proceeds from sale of stock options to
purchase common shares -- -- 7,443,118
Proceeds from issuance of notes payable -- -- 1,500,000
Repayment of notes payable -- -- (140,968)
------------ ------------- -------------------
Net cash provided by financing activities -- -- 113,897,019
------------ ------------- -------------------
Net increase (decrease) in cash (5,595,520) (5,005,628) 9,558,775
Cash at beginning of period 15,154,295 25,855,668 --
------------ ------------- -------------------
Cash at end of period $ 9,558,775 20,850,040 9,558,775
============ ============= ====================
</TABLE>
See accompanying independent accountants' review report.
<PAGE> 12
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Notes to Financial Statements
November 30, 2000
(1) BASIS OF PRESENTATION
The interim financial statements presented are unaudited but, in the
opinion of management, have been prepared in conformity with accounting
principles generally accepted in the United States of America applied on a
basis consistent with those of the annual financial statements. Such
interim financial statements reflect all adjustments (consisting of normal
recurring accruals) necessary for a fair presentation of the financial
position and the results of operations for the interim periods presented.
The results of operations for the interim period presented are not
necessarily indicative of the results to be expected for the year ending
May 31, 2001. The interim financial statements should be read in
connection with the audited financial statements for the year ended May
31, 2000.
(2) COMPUTATION OF NET LOSS PER SHARE
Basic earnings per share is based on the weighted average number of shares
outstanding and excludes the dilutive effect of unexercised common stock
equivalents. Diluted earnings per share is based on the weighted average
number of shares outstanding and includes the dilutive effect of
unexercised common stock equivalents. Because the Company reported a net
loss for all periods presented, per share amounts reflect the use of the
Basic method only.
<PAGE> 13
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS.
Since Northfield's incorporation in 1985, we have devoted substantially
all of our efforts and resources to the research, development and clinical
testing of our potential product, PolyHeme(TM). We have incurred operating
losses during each year of our operations since inception and expect to incur
substantial additional operating losses for the next several years. From
Northfield's inception through November 30, 2000, we have incurred operating
losses totaling $82,085,000.
Our success will depend on several factors, including our ability to
obtain Food & Drug Administration regulatory approval of PolyHeme and our
manufacturing facilities, obtain sufficient quantities of blood to manufacture
PolyHeme in commercial quantities, manufacture and distribute PolyHeme in a
cost-effective manner, and enforce our patent positions. We have experienced
significant delays in the development and clinical testing of PolyHeme. We
cannot ensure that we will be able to achieve these goals or that we will be
able to realize product revenues or profitability on a sustained basis or at
all.
We anticipate that research and development expenses will increase
during the foreseeable future. These expected increases are attributable to
anticipated future clinical trials, monitoring and reporting the results of
these trials and continuing process development associated with improving our
manufacturing capacity to permit commercial-scale production of PolyHeme. We
expect that general and administrative expenses will increase over the
foreseeable future due to increased expenses relating to the expansion of our
organization in support of expanded commercial operations.
<PAGE> 14
RESULTS OF OPERATIONS
We reported no revenues for either of the three-month periods ended
November 30, 2000 or 1999. From Northfield's inception through November 30,
2000, we have reported total revenues of $3,000,000, all of which were derived
from licensing fees.
OPERATING EXPENSES
Operating expenses for our second fiscal quarter ended November 30,
2000 totaled $2,795,000, a decrease of $91,000 from the $2,886,000 reported in
the second quarter of the prior fiscal year. Measured on a percentage basis,
total expenses in the second quarter of fiscal 2001 decreased by 3.2%. This
decrease was due to the lower costs of conducting our clinical trials.
Research and development expenses for the second quarter of fiscal 2001
totaled $2,237,000, a decrease of $125,000, or 5.3%, from the $2,362,000,
reported in the second quarter of fiscal 2000. The majority of the decrease in
research and development expenses resulted from reduced costs associated with
our clinical trials, offsetting cost increases in labor and purchased services.
The clinical trials continue to shift from field work in the hospitals to data
accumulation and analysis resulting in lower period costs. Phase II and Phase
III trials remain active in the field, but patient accrual has slowed.
<PAGE> 15
For the six-month period ended November 30, 2000, research and
development expenses of $4,475,000 was nearly identical to the $4,487,000 of
expense incurred in the comparable prior year period. Within the totals,
significant line item variations exist. Higher employment levels and salary
increases have pushed labor costs up while purchased services have decreased as
a 3rd party viral inactivation study conducted during the first half of the last
fiscal year has not been repeated. Clinical trial expenses have also decreased.
We anticipate that research and development expenses will remain stable
over the balance of the fiscal year. Beyond that, we expect these expenses to
increase significantly. Additional costs are being planned for additional
multi-center clinical trials, third party clinical monitoring, biostatistical
analysis, report preparation, expanding our manufacturing organization and
developing additional sources of hemoglobin.
General and administrative expenses in the second quarter of fiscal
2001 totaled $558,000 compared to expenses of $524,000 in the second quarter of
2000, representing an increase of $34,000, or 6.5%. The increase was due to
costs associated with the contested proxy for the election of directors.
General and administrative expenses for the six-month period ended
November 30, 2000 totaled $1,428,000, which represents a $420,000, or 41.7%,
increase from the $1,008,000 in the comparable prior year period. All of the
increase was due to costs associated with the contested proxy for the election
of directors.
<PAGE> 16
INTEREST INCOME
Interest income in the second quarter of fiscal 2001 totaled $551,000,
or a $28,000 decrease from the $579,000 in interest income reported in the
second quarter of fiscal 2000. Higher interest rates in fiscal 2001 somewhat
offset lower available investment balances to account for the decrease. Interest
income is expected to remain below prior year levels for the remainder of fiscal
2001 as we continue to utilize our existing cash resources to fund our business.
Interest income for the six-month period ended November 30, 2000
totaled $1,141,000, or an $8,000 decrease from the comparable prior year period.
Higher interest rates in the current fiscal year offset declining investment
balances and combined to cause a modest decrease in interest income.
NET LOSS
The net loss for the second quarter ended November 30, 2000 was
$2,243,000, or $.16 per basic share, compared to a net loss of $2,307,000, or
$.16 per basic share, for the second quarter ended November 30, 1999.
For the six-month period ended November 30, 2000, Northfield reported a
loss of $4,761,000, or $.33 per basic share, compared to the comparable prior
year period results of a
<PAGE> 17
loss of $4,346,000, or $.31 per basic share. Higher general and administrative
expenses related to the contested proxy for the election of directors were the
primary reason for the increased per basic share loss.
LIQUIDITY AND CAPITAL RESOURCES
From Northfield's inception through November 30, 2000, we have used
cash for operating activities and for the purchase of engineering services and
property, plant and equipment in the amount of $82,430,000. For the six-month
periods ended November 30, 2000 and 1999, these cash expenditures totaled
$4,954,000, and $ 5,387,000, respectively. The decreased cash outlay for fiscal
2001 compared to the comparable prior year period reflects a decreased level of
capital spending.
We have financed our research and development and other activities to
date primarily through the public and private sale of equity securities and, to
a more limited extent, through the licensing of product rights. As of November
30, 2000, we had cash and marketable securities totaling $33,330,000.
We believe our existing capital resources will be adequate to satisfy
our operating capital requirements and maintain our existing manufacturing plant
and office facilities for approximately the next 24-36 months. Thereafter, we
are likely to require substantial additional capital to continue our operations.
We are currently unable to fund the construction of a large-scale greenfield
manufacturing facility, which is estimated to cost approximately $45 million,
without raising
<PAGE> 18
substantial additional capital. Currently, we have manufacturing capacity of
approximately 10,000 units annually. Initial engineering on the leased space
adjacent to our existing manufacturing facility is completed. This engineering
indicates an additional annual capacity of approximately 75,000 units could be
developed in approximately 16-18 months at an estimated cost of $23-26 million.
Without additional funding, the build-out of the adjacent space would reduce
the estimated life of our existing cash resources to less than one year.
Northfield has not yet committed to the build-out. We view the smaller facility
as financially prudent yet large enough for commercial viability.
We may enter into collaborative arrangements with strategic partners
which could provide us with additional funding or absorb expenses we would
otherwise be required to pay. We have engaged in discussions with a number of
potential strategic partners. These discussions are at various stages and we
cannot ensure that any of these arrangements will be consummated.
Our capital requirements may vary materially from those now anticipated
because of the results of our clinical testing of PolyHeme, the establishment of
relationships with strategic partners, changes in the scale, timing or cost of
our commercial manufacturing facility, competitive and technological advances,
the FDA regulatory process, changes in our marketing and distribution strategy
and other factors.
<PAGE> 19
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 10-Q
EXHIBIT 15 - Letter RE: Unaudited Interim Financial Information
(b) None.
<PAGE> 20
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange
Act of 1934, the Company has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized, on January 12, 2001.
NORTHFIELD LABORATORIES INC.
By /s/ RICHARD E. DEWOSKIN
---------------------------------------
Richard E. DeWoskin
Chairman of the Board and
Chief Executive Officer
By /s/ JACK J. KOGUT
---------------------------------------
Jack J. Kogut
Secretary and Treasurer
(principal financial officer and
principal accounting officer)