1
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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 FEBRUARY 28, 2001
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 FEBRUARY 28, 2001, REGISTRANT HAD 14,265,875 SHARES OF COMMON STOCK
OUTSTANDING
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2
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 February 28, 2001, and the related statements of
operations for the three-month periods ended February 28, 2001 and February 29,
2000, and statements of operations and cash flows for the nine-month periods
ended February 28, 2001 and February 29, 2000 and for the period from June 19,
1985 (inception) through February 28, 2001. We have also reviewed the statements
of shareholders' equity (deficit) for the nine-month period ended February 28,
2001 and for the period from June 19, 1985 (inception) through February 28,
2001. 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
Chicago, Illinois
March 21, 2001
3
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
February 28, 2001 (unaudited) and May 31, 2000
FEBRUARY 28, MAY 31,
ASSETS 2001 2000
------------- -------------
Current assets:
Cash $ 7,299,077 15,154,295
Short-term marketable securities 23,799,980 23,129,324
Prepaid expenses 223,629 409,270
Other current assets 632,555 505,572
------------- -------------
Total current assets 31,955,241 39,198,461
Property, plant, and equipment, net 2,811,257 2,455,701
Other assets 122,775 74,333
------------- -------------
$ 34,889,273 41,728,495
============= =============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,347,153 1,061,367
Accrued expenses 149,551 174,009
Accrued compensation and benefits 268,620 250,570
------------- -------------
Total current liabilities 1,765,324 1,485,946
Other liabilities 167,231 147,717
------------- -------------
Total liabilities 1,932,555 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 14,265,875 shares
at February 28, 2001 and May 31, 2000, respectively 142,659 142,424
Additional paid-in capital 117,503,271 117,276,051
Deficit accumulated during the development stage (84,689,212) (77,323,643)
------------- -------------
Total shareholders' equity 32,956,718 40,094,832
------------- -------------
$ 34,889,273 41,728,495
============= =============
See accompanying independent accountants' review report.
4
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three and nine-month periods ended February 28, 2001 and February 29,
2000 and for the period from June 19, 1985
(inception) through February 28, 2001
CUMULATIVE
THREE-MONTH PERIOD ENDED NINE-MONTH PERIOD ENDED FROM
------------------------------ ---------------------------- JUNE 19, 1985
FEBRUARY 28, FEBRUARY 29, FEBRUARY 28, FEBRUARY 29, THROUGH
2001 2000 2001 2000 FEBRUARY 28, 2001
(UNAUDITED) (UNAUDITED) (UNAUDITED) (UNAUDITED) (UNAUDITED)
----------- ----------- ----------- ----------- -----------------
Revenues - license income -- -- -- -- 3,000,000
Costs and expenses:
Research and development $ 2,488,972 2,364,773 6,963,676 6,851,403 76,104,089
General and administrative 620,079 657,759 2,047,582 1,666,064 33,518,795
------------ ---------- ---------- ---------- -----------
3,109,051 3,022,532 9,011,258 8,517,467 109,622,884
------------ ---------- ---------- ---------- -----------
Other income and expense:
Interest income 504,733 558,499 1,645,689 1,707,652 22,016,906
Interest expense -- -- -- -- (83,234)
------------ ---------- ---------- ---------- -----------
504,733 558,499 1,645,689 1,707,652 21,933,672
------------ ---------- ---------- ---------- -----------
Net loss $ (2,604,318) (2,464,033) (7,365,569) (6,809,815) (84,689,212)
============ ========== ========== ========== ===========
Net loss per basic share $ (0.18) (0.17) (0.52) (0.48) (9.18)
============ ========== ========== ========== ===========
Shares used in calculation of per share data 14,263,003 14,240,864 14,252,632 14,240,203 9,224,175
============ ========== ========== ========== ===========
See accompanying independent accountants' review report.
5
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit)
Nine-month period ended February 28, 2001
and for the period from June 19, 1985
(inception) through February 28, 2001
SERIES A CONVERTIBLE
PREFERRED STOCK COMMON STOCK PREFERRED STOCK
--------------------- ----------------------- ----------------------
NUMBER AGGREGATE NUMBER AGGREGATE NUMBER AGGREGATE
OF SHARES AMOUNT OF SHARES AMOUNT OF SHARES AMOUNT
--------- --------- ---------- --------- --------- ----------
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) -- -- -- -- 250,000 250,000
Net loss -- -- -- -- -- --
------ ------- --------- --------- -------- ---------
Balance at May 31, 1986 -- -- 3,500,000 35,000 250,000 250,000
Net loss -- -- -- -- -- --
Deferred compensation relating to grant of
stock options -- -- -- -- -- --
Amortization of deferred compensation -- -- -- -- -- --
------ ------- --------- --------- -------- ---------
Balance at May 31, 1987 -- -- 3,500,000 35,000 250,000 250,000
Issuance of Series B convertible preferred
stock at $35.68 per share on August 14,
1987 (net of costs of issuance of $75,450) -- -- -- -- -- --
Net loss -- -- -- -- -- --
Amortization of deferred compensation -- -- -- -- -- --
------ ------- --------- --------- -------- ---------
Balance at May 31, 1988 -- -- 3,500,000 35,000 250,000 250,000
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 (250,000) (250,000)
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 -- --
------ ------- --------- --------- -------- ---------
(Continued)
6
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit)
Nine-month period ended February 28, 2001
and for the period from June 19, 1985
(inception) through February 28, 2001
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)
--------- --------- ----------- ------------- ---------- ----------
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) 200,633 200,633 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 200,633 200,633 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 (200,633) (200,633) 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
------- ----------- ---------- ---------- ---------- ----------
(Continued)
7
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit), continued
Nine months ended February 28,
2001 and for the period from June 19, 1985
(inception) through February 28, 2001
SERIES A CONVERTIBLE SERIES B CONVERTIBLE
PREFERRED STOCK COMMON STOCK PREFERRED STOCK PREFERRED STOCK
------------------- ------------------- -------------------- -------------------
NUMBER AGGREGATE NUMBER AGGREGATE NUMBER AGGREGATE NUMBER AGGREGATE
OF SHARES AMOUNT OF SHARES AMOUNT OF SHARES AMOUNT OF SHARES AMOUNT
--------- --------- --------- --------- --------- --------- --------- ---------
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
$423,238) -- -- 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) -- -- -- -- -- -- -- --
Exercise of stock options at $10.81 per share -- -- 17,500 175 -- -- -- --
Exercise of stock options at $6.38 per share -- -- 6,000 60 -- -- -- --
----- ------- ---------- -------- ----- ------- ----- --------
Balance at February 28, 2001 (unaudited) -- $ -- 14,265,875 $142,659 -- $ -- -- $ --
===== ======= ========== ======== ===== ======= ===== ========
See accompanying independent accountants' review report.
(Continued)
8
DEFICIT TOTAL
ACCUMULATED SHARE-
ADDITIONAL DURING THE DEFERRED HOLDERS'
PAID-IN DEVELOPMENT COMPEN- EQUITY
CAPITAL STAGE SATION (DEFICIT)
------------ ------------ ------------ ------------
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
$423,238) 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) -- (7,365,569) -- (7,365,569)
Exercise of stock options at $10.81 per share 189,000 -- -- 189,175
Exercise of stock options at $6.38 per share 38,220 -- -- 33,280
------------ ------------ ------------ ------------
Balance at February 28, 2001 (unaudited) 117,503,271 (84,689,212) -- 32,956,718
============ ============ ============ ============
(Continued)
9
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Cash Flows
Nine-month periods ended February 28, 2001 and February 29,
2000 and for the period from June 19, 1985
(inception) through February 28, 2001
NINE MONTHS ENDED CUMULATIVE
---------------------------- FROM
FEBRUARY 28, FEBRUARY 29, JUNE 19, 1985
---------------------------- THROUGH
2001 2000 FEBRUARY 28, 2001
(UNAUDITED) (UNAUDITED) (UNAUDITED)
----------- ----------- ------------------
Cash flows from operating activities:
Net loss $ (7,365,569) (6,809,815) (84,689,212)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 368,758 325,417 15,017,387
Non-cash compensation -- 74,328 3,552,723
Loss on sale of equipment -- -- 66,359
Changes in assets and liabilities:
Prepaid expenses 185,641 194,964 (432,840)
Other current assets (126,983) (61,126) (2,528,806)
Other assets (49,200) -- (42,247)
Accounts payable 285,786 (353,771) 1,347,153
Accrued expenses (24,458) (8,716) 149,551
Accrued compensation and benefits 18,050 38,215 268,620
Other liabilities 19,514 16,510 167,231
------------ ---------- ---------
Net cash used in operating activities (6,688,461) (6,583,994) (67,124,081)
------------ ---------- ---------
Cash flows from investing activities:
Purchase of property, plant, equipment,
and capitalized engineering costs (723,556) (2,145,445) (17,764,358)
Proceeds from matured marketable securities 7,548,171 15,549,200 362,938,152
Proceeds from sale of marketable securities -- -- 7,141,656
Purchase of marketable securities (8,218,827) (4,909,192) (393,879,789)
Proceeds from sale of equipment -- 1,786,436 1,863,023
------------ ---------- ---------
Net cash used in investing activities (1,394,212) 10,280,999 (39,701,316)
------------ ---------- ---------
Cash flows from financing activities:
Proceeds from issuance of common stock 227,455 33,450 103,749,383
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 227,455 33,450 114,124,474
------------ ---------- ---------
Net increase (decrease) in cash (7,855,218) 3,730,455 7,299,077
Cash at beginning of period 15,154,295 25,855,668 --
------------ ---------- ---------
Cash at end of period $ 7,299,077 29,586,123 7,299,077
============ ========== ===========
See accompanying independent accountants' review report.
10
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Notes to Financial Statements
February 28, 2001
(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, basic and diluted per share amounts are the same.
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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 February 28, 2001, we have incurred operating
losses totaling $84,689,000.
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 potential expanded commercial operations.
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RESULTS OF OPERATIONS
We reported no revenues for either of the three-month periods ended
February 28, 2001 or 2000. From Northfield's inception through February 28,
2001, we have reported total revenues of $3,000,000, all of which were derived
from licensing fees.
OPERATING EXPENSES
Operating expenses for our third fiscal quarter ended February 28, 2001
totaled $3,109,000, an increase of $86,000 from the $3,023,000 reported in the
third quarter of the prior fiscal year. Measured on a percentage basis, total
expenses in the third quarter of fiscal 2001 increased by 2.8%. This increase
was primarily due to higher costs related to the expansion of our manufacturing
organization and facilities.
Research and development expenses for the third quarter of fiscal 2001
totaled $2,489,000, an increase of $124,000, or 5.2%, from the $2,365,000,
reported in the third quarter of fiscal 2000. The majority of the increase in
research and development expenses resulted from increased costs associated with
our expanded manufacturing organization and facilities. The clinical trials
continue to shift from field work in the hospitals to data accumulation and
analysis. Phase II and Phase III trials remain active in the field, but patient
accrual has slowed.
Research and development expenses for the nine-month period ended
February 28, 2001 totaled $6,964,000, an increase of $113,000 or 1.6%, from the
$6,851,000 of expense incurred in the comparable prior year period. The nature
of expenditures has changed as higher
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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.
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 third quarter of fiscal 2001
totaled $620,000 compared to expenses of $658,000 in the third quarter of 2000,
representing a decrease of $38,000, or 5.8%. The decrease was primarily due to
lower travel expense.
General and administrative expenses for the nine-month period ended
February 28, 2001 totaled $2,048,000, which represents a $382,000, or 22.9%,
increase from the $1,666,000 in the comparable prior year period. All of the
increase was due to higher legal fees.
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INTEREST INCOME
Interest income in the third quarter of fiscal 2001 totaled $505,000,
or a $53,000 decrease from the $558,000 in interest income reported in the third
quarter of fiscal 2000. Higher interest rates early in fiscal 2001 somewhat
offset lower available investment balances to account for the decrease.
Currently available short-term interest rates are yielding over 2% less than the
rates available for the comparable prior year period. Consequently, interest
income will remain below prior year levels for the remainder of fiscal 2001 as
the corporation will be investing smaller amounts which will be earning lower
interest rates.
Interest income for the nine-month period ended February 28, 2001
totaled $1,646,000, or a $62,000 decrease from the comparable prior year period.
Higher interest rates available earlier in the current fiscal year offset
declining investment balances and combined to cause the modest decrease in
interest income. On a going forward basis, lower available interest rates and
lower available investment balances will cause future interest income to remain
below prior year levels.
NET LOSS
The net loss for the third quarter ended February 28, 2001 was
$2,604,000, or $.18 per basic share, compared to a net loss of $2,464,000, or
$.17 per basic share, for the third quarter ended February 29, 2000. The
difference is due to the increased expense associated with our expanded
manufacturing organization and facility costs.
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For the nine-month period ended February 28, 2001, Northfield reported
a loss of $7,366,000, or $.52 per basic share, compared to the comparable prior
year period results of a loss of $6,810,000, or $.48 per basic share. Higher
legal fees combined with an expanded manufacturing organization and higher
facility costs accounted for the increased loss.
LIQUIDITY AND CAPITAL RESOURCES
From Northfield's inception through February 28, 2001, we have used
cash for operating activities and for the purchase of engineering services and
property, plant and equipment in the amount of $84,888,000. For the nine-month
periods ended February 28, 2001 and 2000, these cash expenditures totaled
$7,412,000, and $8,729,000, 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 February
28, 2001, we had cash and marketable securities totaling $31,099,000.
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 24-30 months. Thereafter, we
are likely to require substantial additional capital to continue our
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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 substantial additional capital. Currently, we have
manufacturing capacity of approximately 10,000 units. Initial engineering on the
leased space adjacent to our existing manufacturing facility is completed. This
engineering indicates an additional capacity of 75,000 units could be developed
in approximately 16-18 months at a cost of $26-30 million. Like the greenfield
project, significant additional funding will be required before the smaller
scale expansion facility could be completed. Northfield has not yet committed to
the build-out of a smaller scale expansion facility. We view the smaller scale
expansion 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.
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PART II. OTHER INFORMATION
Item 6. Exhibits
a) Exhibit 10.15 - Employment Agreement - Richard DeWoskin
Exhibit 10.16 - Employment Agreement - Steven A. Gould, MD
Exhibit 10.17 - Employment Agreement - Jack Kogut
Exhibit 10.18 - Form of Indemnification Agreement - Director and
Executive Officer, Richard DeWoskin and
Steven A. Gould, MD
Exhibit 10.19 - Form of Indemnification Agreement - Director, Gerald
Moss, MD, Bruce Chelberg, David Savner, and Jack Olshansky
Exhibit 10.20 - Form of Indemnification Agreement - Executive Officer,
Jack Kogut
Exhibit 15 - Acknowledgement of Independent Certified Public
Accountants
b) None.
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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 April 13, 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)