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UNITED STATES
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 QUARTERLY PERIOD ENDED FEBRUARY 28, 2006
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES
EXCHANGE ACT OF 1934
FOR THE TRANSITION PERIOD FROM _______________ TO _______________
COMMISSION FILE NUMBER 0-24050
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
INDICATE BY CHECK MARK WHETHER THE REGISTRANT (1) HAS FILED ALL REPORTS
REQUIRED TO BE FILED BY SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF
1934 DURING THE PRECEDING 12 MONTHS (OR FOR SUCH SHORTER PERIOD THAT THE
REGISTRANT WAS REQUIRED TO FILE SUCH REPORTS), AND (2) HAS BEEN SUBJECT TO SUCH
FILING REQUIREMENTS FOR THE PAST 90 DAYS.
YES X NO
--- ---
INDICATE BY CHECK MARK WHETHER THE REGISTRANT IS A LARGE ACCELERATED FILER,
AN ACCELERATED FILER, OR A NON-ACCELERATED FILER. SEE DEFINITION OF "ACCELERATED
FILER OR LARGE ACCELERATED FILER" IN RULE 12B-2 OF THE EXCHANGE ACT. (CHECK
ONE):
LARGE ACCELERATED FILER ACCELERATED FILER X NON-ACCELERATED FILER
--- --- ---
INDICATE BY CHECK MARK WHETHER THE REGISTRANT IS A SHELL COMPANY (AS
DEFINED IN RULE 12B-2 OF THE EXCHANGE ACT). YES NO X
--- ---
AS OF FEBRUARY 28, 2006, REGISTRANT HAD 26,772,938 SHARES OF COMMON STOCK
OUTSTANDING
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION
This Quarterly Report contains forward-looking statements concerning, among
other things, our prospects, clinical and regulatory developments affecting our
potential product and our business strategies. These forward-looking statements
are identified by the use of such terms as "intends," "expects," "plans,"
"estimates," "anticipates," "forecasts," "should," "believes" and similar terms.
These forward-looking statements involve risks and uncertainties. Actual results
may differ materially from those predicted by the forward-looking statements
because of various factors and possible events, including those discussed under
"Risk Factors" in our Annual Report on Form 10-K filed with the Securities and
Exchange Commission and those matters discussed under "Legal Proceedings" in
this Quarterly Report. Because these forward-looking statements involve risks
and uncertainties, actual results may differ significantly from those predicted
in these forward-looking statements. You should not place undue weight on these
statements. These statements speak only as of the date of this document or, in
the case of any document incorporated by reference, the date of that document.
All subsequent written and oral forward-looking statements attributable to
Northfield or any person acting on our behalf are qualified by the cautionary
statements in this section and in our Annual Report. We will have no obligation
to revise these forward-looking statements.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
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, 2006, and the related statements of
operations for the three-month periods ended February 28, 2006 and 2005, and the
statements of operations and cash flows for the nine-month periods ended
February 28, 2006 and 2005, and for the period from June 19, 1985 (inception)
through February 28, 2006. We have also reviewed the statements of shareholders'
equity (deficit) for the nine-month period ended February 28, 2006 and for the
period from June 19, 1985 (inception) through February 28, 2006. These financial
statements are the responsibility of the Company's management.
We conducted our review in accordance with the standards of the Public Company
Accounting Oversight Board (United States). A review of interim financial
information consists principally of applying analytical procedures and making
inquiries of persons responsible for financial and accounting matters. It is
substantially less in scope than an audit conducted in accordance with the
standards of the Public Company Accounting Oversight Board (United States), 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 U.S. generally accepted accounting principles.
We have previously audited, in accordance with the standards of the Public
Company Accounting Oversight Board (United States), the balance sheet of
Northfield Laboratories Inc. as of May 31, 2005, 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, 2005
(not presented herein); and in our report dated August 12, 2005, 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, 2005 and
in the accompanying statements of operations, cash flows and shareholders'
equity (deficit) is fairly stated, in all material respects, in relation to the
statements from which it has been derived.
/s/ KPMG LLP
Chicago, Illinois
April 7, 2006
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Balance Sheets
February 28, 2006 and May 31, 2005
FEBRUARY 28, MAY 31,
2006 2005
------------- ------------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 49,502,733 6,800,405
Marketable securities 30,810,081 91,330,289
Prepaid expenses 281,087 826,741
Other current assets -- 139,808
------------- ------------
Total current assets 80,593,901 99,097,243
Property, plant, and equipment 15,281,206 14,796,631
Accumulated depreciation (14,165,914) (13,961,694)
------------- ------------
Net property, plant, and equipment 1,115,292 834,937
------------- ------------
Other assets 69,064 69,392
------------- ------------
$ 81,778,257 100,001,572
============= ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 3,196,617 3,325,570
Accrued expenses 80,559 110,679
Accrued compensation and benefits 619,944 539,783
------------- ------------
Total current liabilities 3,897,120 3,976,032
Other liabilities 239,240 251,582
------------- ------------
Total liabilities 4,136,360 4,227,614
------------- ------------
Shareholders' equity:
Preferred stock, $.01 par value. Authorized 5,000,000 shares;
none issued and outstanding -- --
Common stock, $.01 par value. Authorized 60,000,000 shares;
issued 26,774,655 at February 28, 2006 and 26,752,739 at
May 31, 2005 267,747 267,527
Additional paid-in capital 241,223,371 240,997,444
Deficit accumulated during the development stage (163,805,807) (145,361,011)
Deferred compensation (18,021) (104,609)
------------- ------------
77,667,290 95,799,351
Less cost of 1,717 common shares in treasury (25,393) (25,393)
------------- ------------
Total shareholders' equity 77,641,897 95,773,958
------------- ------------
$ 81,778,257 100,001,572
============= ============
See accompanying notes to financial statements and accountants' review report.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Operations
Three and nine months ended February 28, 2006 and February 28, 2005 and
for the period from June 19, 1985 (inception) through February 28, 2006
CUMULATIVE
FROM
THREE MONTHS ENDED FEBRUARY 28, NINE MONTHS ENDED FEBRUARY 28, JUNE 19, 1985
------------------------------- ------------------------------ THROUGH
2006 2005 2006 2005 FEBRUARY 28, 2006
----------- ----------- ----------- ----------- -----------------
(unaudited) (unaudited) (unaudited) (unaudited) (unaudited)
Revenues - license income $ -- -- -- -- 3,000,000
Costs and expenses:
Research and development 5,786,424 3,817,764 16,453,600 12,033,650 140,069,391
General and administrative 1,453,876 1,310,923 4,302,696 3,169,711 53,746,298
----------- ---------- ----------- ----------- ------------
7,240,300 5,128,687 20,756,296 15,203,361 193,815,689
Other income and expense:
Interest income 845,342 281,109 2,311,500 557,115 27,168,037
Interest expense -- -- -- -- 83,234
----------- ---------- ----------- ----------- ------------
$ 845,342 281,109 2,311,500 557,115 27,084,803
----------- ---------- ----------- ----------- ------------
Net loss before cumulative effect of change
in accounting principle (6,394,958) (4,847,578) (18,444,796) (14,646,246) (163,730,886)
----------- ---------- ----------- ----------- ------------
Cumulative effect of change in
accounting principle -- -- -- -- 74,921
----------- ---------- ----------- ----------- ------------
Net loss $(6,394,958) (4,847,578) (18,444,796) (14,646,246) (163,805,807)
=========== ========== =========== =========== ============
Net loss per share - basic and diluted $ (0.24) (0.21) (0.69) (0.67) (14.28)
=========== ========== =========== =========== ============
Shares used in calculation of
per share data - basic and diluted 26,769,380 22,658,213 26,764,146 21,829,722 11,467,942
=========== ========== =========== =========== ============
See accompanying notes to financial statements and accountants' review report.
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit)
Nine months ended February 28, 2006 and for the period
from June 19, 1985 (inception) through February 28, 2006
PREFERRED STOCK COMMON STOCK
-------------------- ---------------------
NUMBER AGGREGATE NUMBER AGGREGATE
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) -- -- -- --
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
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
See accompanying notes to financial statements and accountants' review report.
SERIES A CONVERTIBLE SERIES B CONVERTIBLE DEFICIT TOTAL
PREFERRED STOCK PREFERRED STOCK ACCUMULATED SHARE-
-------------------- -------------------- ADDITIONAL DURING THE DEFERRED HOLDERS'
NUMBER AGGREGATE NUMBER AGGREGATE PAID-IN DEVELOPMENT COMPEN- TREASURY EQUITY
OF SHARES AMOUNT OF SHARES AMOUNT CAPITAL STAGE SATION SHARES (DEFICIT)
--------- --------- --------- --------- ----------- ------------ ----------- -------- -----------
-- $ -- -- $ -- $ (28,000) $ -- $ -- -- $ 7,000
250,000 250,000 -- -- 670,850 -- -- -- 920,850
-- -- -- -- -- (607,688) -- -- (607,688)
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
250,000 250,000 -- -- 642,850 (607,688) -- -- 320,162
-- -- -- -- -- (2,429,953) -- -- (2,429,953)
-- -- -- -- 2,340,000 -- (2,340,000) -- --
-- -- -- -- -- -- 720,000 -- 720,000
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
250,000 250,000 -- -- 2,982,850 (3,037,641) (1,620,000) -- (1,389,791)
-- -- 200,633 200,633 6,882,502 -- -- -- 7,083,135
-- -- -- -- -- (3,057,254) -- -- (3,057,254)
-- -- -- -- -- -- 566,136 -- 566,136
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
250,000 250,000 200,633 200,633 9,865,352 (6,094,895) (1,053,864) -- 3,202,226
-- -- -- -- 9,749,870 -- -- -- 9,754,000
(250,000) (250,000) -- -- 237,500 -- -- -- --
-- -- (200,633) (200,633) 190,601 -- -- -- --
-- -- -- -- 93,759 -- -- -- 94,230
-- -- -- -- 4,976,855 -- -- -- 4,978,610
-- -- -- -- 2,488,356 -- -- -- 2,489,234
-- -- -- -- 7,443,118 -- -- -- 7,443,118
-- -- -- -- -- (791,206) -- -- (791,206)
-- -- -- -- 683,040 -- (683,040) -- --
-- -- -- -- -- -- 800,729 -- 800,729
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- -- -- -- 35,728,451 (6,886,101) (936,175) -- 27,970,941
-- -- -- -- -- (3,490,394) -- -- (3,490,394)
-- -- -- -- 699,163 -- (699,163) -- --
-- -- -- -- -- -- 546,278 -- 546,278
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- -- -- -- 36,427,614 (10,376,495) (1,089,060) -- 25,026,825
-- -- -- -- -- (5,579,872) -- -- (5,579,872)
-- -- -- -- -- -- 435,296 -- 435,296
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- -- -- -- 36,427,614 (15,956,367) (653,764) -- 19,882,249
-- -- -- -- 503,100 -- -- -- 504,000
-- -- -- -- -- (7,006,495) -- -- (7,006,495)
-- -- -- -- -- -- 254,025 -- 254,025
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- -- -- -- 36,930,714 (22,962,862) (399,739) -- 13,633,779
-- -- -- -- 106,890 -- -- -- 107,040
-- -- -- -- 5,663,710 -- -- -- 5,667,454
-- -- -- -- -- (8,066,609) -- -- (8,066,609)
-- -- -- -- -- -- 254,025 -- 254,025
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- -- -- -- 42,701,314 (31,029,471) (145,714) -- 11,595,689
-- -- -- -- -- (7,363,810) -- -- (7,363,810)
-- -- -- -- 14,163,851 -- -- -- 14,188,851
-- -- -- -- (85,400) -- 85,400 -- --
-- -- -- -- -- -- 267 -- 267
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- -- -- -- 56,779,765 (38,393,281) (60,047) -- 18,420,997
-- -- -- -- -- (7,439,013) -- -- (7,439,013)
-- -- -- -- 2,261,250 -- -- -- 2,265,000
-- -- -- -- 71,300 -- -- -- 71,400
-- -- -- -- 373,264 -- -- -- 375,139
-- -- -- -- (106,750) -- 106,750 -- --
-- -- -- -- -- -- (67,892) -- (67,892)
-------- --------- -------- --------- ----------- ------------ ----------- --- -----------
-- $ -- -- $ -- $59,378,829 $(45,832,294) $ (21,189) -- $13,625,631
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Shareholders' Equity (Deficit)
Nine months ended February 28, 2006 and for the period
from June 19, 1985 (inception) through February 28, 2006
PREFERRED STOCK COMMON STOCK
--------------------- ----------------------
NUMBER AGGREGATE NUMBER AGGREGATE
OF SHARES AMOUNT OF SHARES AMOUNT
--------- --------- ---------- ---------
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 -- -- -- --
Non-cash compensation -- -- -- --
Exercise of stock options at $6.38 per share -- -- 6,000 60
Exercise of stock options at $10.81 per share -- -- 17,500 175
--- --- ---------- --------
Balance at May 31, 2001 -- -- 14,265,875 142,659
Net loss -- -- -- --
--- --- ---------- --------
Balance at May 31, 2002 -- -- 14,265,875 142,659
Net loss -- -- -- --
--- --- ---------- --------
Balance at May 31, 2003 -- -- 14,265,875 142,659
Issuance of common stock at $5.60 per share on July 28,
2003 (net of costs of issuance of $909,229) -- -- 1,892,857 18,928
Issuance of common stock to directors at $6.08 per
share on October 30, 2003 -- -- 12,335 123
Deferred compensation related to stock grants -- -- 25,500 255
Amortization of deferred compensation -- -- -- --
Issuance of common stock at $5.80 per share on January 29,
2004 (net of costs of issuance of $1,126,104) -- -- 2,585,965 25,860
Issuance of common stock at $5.80 per share on February 18,
2004 (net of costs of issuance of $116,423) -- -- 237,008 2,370
Issuance of common stock at $5.80 per share on April 15,
2004 (net of costs of issuance of $192,242) -- -- 409,483 4,095
Issuance of common stock at $12.00 per share on May 18,
2004 (net of costs of issuance of $1,716,831.36) -- -- 1,954,416 19,544
Exercise of stock options at $6.38 per share -- -- 15,000 150
Net loss -- -- -- --
--- --- ---------- --------
Balance at May 31, 2004 21,398,439 213,984
Deferred compensation related to stock grants -- -- 5,500 55
Amortization of deferred compensation -- -- -- --
Exercise of stock options between $5.08 and $14.17 per share -- -- 167,875 1,679
Cost of shares in treasury, 1,717 shares -- -- -- --
Issuance of common stock to directors at $12.66 per share
on September 21, 2004 -- -- 5,925 59
Issuance of common stock at $15.00 per share on February 9,
2005 (net of costs of issuance of $4,995,689) -- -- 5,175,000 51,750
Net loss -- -- -- --
--- --- ---------- --------
Balance at May 31, 2005 $ 26,752,739 $267,527
Amortization of deferred compensation (unaudited) -- -- -- --
Exercise of stock options at $7.13 and $10.66 per share
(unaudited) -- -- 2,875 29
Issuance of common stock to directors at $13.05 per share
on September 29, 2005 (unaudited) -- -- 5,750 57
Issuance of common stock to directors at $13.21 per share
on October 3, 2005 (unaudited) -- -- 1,135 12
Issuance of common stock to director at $10.67 per share
on February 24, 2006 (unaudited) 1,406 14
Exercise of stock options at $10.66, $5.15 and $11.09 per
share (unaudited) 8,000 80
Exercise of stock options at $10.66 and $ 7.13 per share
(unaudited) 2,750 28
Net loss (unaudited) -- -- -- --
--- --- ---------- --------
Balance at February 28, 2006 (unaudited) $ 26,774,655 $267,747
=== === ========== ========
See accompanying notes to financial statements and accountants' review report.
SERIES A CONVERTIBLE SERIES B CONVERTIBLE DEFICIT TOTAL
PREFERRED STOCK PREFERRED STOCK ACCUMULATED SHARE-
--------------------- --------------------- ADDITIONAL DURING THE DEFERRED HOLDERS'
NUMBER AGGREGATE NUMBER AGGREGATE PAID-IN DEVELOPMENT COMPEN- TREASURY EQUITY
OF SHARES AMOUNT OF SHARES AMOUNT CAPITAL STAGE SATION SHARES (DEFICIT)
--------- --------- --------- --------- ------------ ------------- --------- -------- ------------
-- $-- -- $-- $ -- $ (4,778,875) $ -- -- $ (4,778,875)
-- -- -- -- 48,324,374 -- -- -- 48,353,624
-- -- -- -- 7,360,187 -- -- -- 7,364,575
-- -- -- -- 362,937 -- -- -- 364,761
-- -- -- -- 9,555 -- -- -- 9,570
-- -- -- -- 71,300 -- -- -- 71,400
-- -- -- -- (80,062) -- 80,062 -- --
-- -- -- -- -- -- (62,726) -- (62,726)
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 115,427,120 (50,611,169) (3,853) -- 64,947,960
-- -- -- -- -- (4,245,693) -- -- (4,245,693)
-- -- -- -- 50,025 -- -- -- 52,658
-- -- -- -- 463,540 -- -- -- 465,869
-- -- -- -- 71,300 -- -- -- 71,400
-- -- -- -- -- -- 2,569 -- 2,569
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 116,011,985 (54,856,862) (1,284) -- 61,294,763
-- -- -- -- -- (5,883,378) -- -- (5,883,378)
-- -- -- -- 35,650 -- -- -- 35,700
-- -- -- -- -- -- 1,284 -- 1,284
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 116,047,635 (60,740,240) -- -- 55,448,369
-- -- -- -- -- (7,416,333) -- -- (7,416,333)
-- -- -- 14,354 -- -- -- 14,354
-- -- -- -- 124,775 -- -- -- 124,950
-- -- -- -- 998,750 -- -- -- 1,000,000
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 117,185,514 (68,156,573) -- -- 49,171,340
-- -- -- -- -- (9,167,070) -- -- (9,167,070)
-- -- -- -- 57,112 -- -- -- 57,112
-- -- -- -- 33,425 -- -- -- 33,450
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 117,276,051 (77,323,643) -- -- 40,094,832
-- -- -- -- -- (10,174,609) -- -- (10,174,609)
-- -- -- -- -- -- -- -- --
-- -- -- -- 38,220 -- -- -- 38,280
-- -- -- -- 189,000 -- -- -- 189,175
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 117,503,271 (87,498,252) -- -- 30,147,678
-- -- -- -- -- (10,717,360) -- -- (10,717,360)
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 117,503,271 (98,215,612) -- -- 19,430,318
-- -- -- -- -- (12,250,145) -- -- (12,250,145)
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 117,503,271 (110,465,757) -- -- 7,180,173
-- -- -- -- 9,671,843 -- -- -- 9,690,771
-- -- -- -- 74,877 -- -- -- 75,000
-- -- -- -- 190,995 -- (191,250) -- --
-- -- -- -- -- -- 35,630 -- 35,630
-- -- -- -- 13,846,633 -- -- -- 13,872,493
-- -- -- -- 1,255,853 -- -- -- 1,258,223
-- -- -- -- 2,178,664 -- -- -- 2,182,759
-- -- -- -- 21,716,616 -- -- -- 21,736,160
-- -- -- -- 95,550 -- -- -- 95,700
-- -- -- -- -- (14,573,798) -- -- (14,573,798)
--- --- --- --- ------------ ------------- --------- ------- ------------
-- -- -- -- 166,534,302 (125,039,555) (155,620) -- 41,553,111
-- -- -- -- 71,055 -- (71,110) -- --
-- -- -- -- -- -- 122,121 -- 122,121
-- -- -- -- 1,739,585 -- -- -- 1,741,264
-- -- -- -- -- -- -- (25,393) (25,393)
-- -- -- -- 74,941 -- -- -- 75,000
-- -- -- -- 72,577,561 -- -- -- 72,629,311
-- -- -- -- -- (20,321,456) -- -- (20,321,456)
--- --- --- --- ------------ ------------- --------- ------- ------------
-- $-- -- $-- $240,997,444 $(145,361,011) $(104,609) (25,393) $ 95,773,958
-- -- -- -- -- -- 86,588 -- 86,588
-- -- -- -- 29,295 -- -- -- 29,324
-- -- -- -- 74,943 -- -- -- 75,000
-- -- -- -- 14,988 -- -- -- 15,000
14,986 15,000
65,075 65,155
26,640 26,668
-- -- -- -- -- (18,444,796) -- -- (18,444,796)
--- --- --- --- ------------ ------------- --------- ------- ------------
-- $-- -- $-- $241,223,371 $(163,805,807) $ (18,021) (25,393) $ 77,641,897
=== === === === ============ ============= ========= ======= ============
NORTHFIELD LABORATORIES INC.
(a company in the development stage)
Statements of Cash Flows
Nine months ended February 28, 2006 and 2005
and for the period from June 19, 1985
(inception) through February 28, 2006
NINE MONTHS ENDED CUMULATIVE FROM
FEBRUARY 28, JUNE 19, 1985
-------------------------- THROUGH
2006 2005 FEBRUARY 28, 2006
------------ ----------- -----------------
(unaudited) (unaudited) (unaudited)
Cash flows from operating activities:
Net loss $(18,444,796) (14,646,246) (163,805,807)
Adjustments to reconcile net loss to net
cash used in operating activities:
Marketable security amortization (1,301,084) 0 (1,902,404)
Depreciation and amortization 204,220 470,605 18,480,928
Non-cash compensation 191,588 164,055 4,052,062
Loss on sale of equipment -- -- 66,359
Changes in assets and liabilities:
Prepaid expenses 545,654 261,268 (490,298)
Other current assets 139,808 (79,389) (1,896,251)
Other assets 328 -- 7,179
Accounts payable (128,953) (388,792) 3,196,617
Accrued expenses (30,120) (65,116) 80,559
Accrued compensation and benefits 80,161 (52,954) 619,944
Other liabilities (12,342) (1,101) 239,240
------------ ----------- ------------
Net cash used in operating activities (18,755,536) (14,337,670) (141,351,872)
------------ ----------- ------------
Cash flows from investing activities:
Purchase of property, plant, equipment, and
capitalized engineering costs (484,575) (201,582) (19,521,954)
Proceeds from sale of land and equipment -- -- 1,863,023
Proceeds from matured marketable securities 146,794,000 11,225,000 576,646,352
Proceeds from sale of marketable securities -- -- 7,141,656
Purchase of marketable securities (84,972,708) (95,769,935) (612,701,381)
------------ ----------- ------------
Net cash provided by (used in) investing activities 61,336,717 (84,746,517) (46,572,304)
------------ ----------- ------------
Cash flows from financing activities:
Proceeds from issuance of common stock 121,147 79,327,988 236,108,337
Payment of common stock issuance costs -- (4,995,689) (14,128,531)
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 121,147 74,332,299 237,426,909
------------ ----------- ------------
Net increase (decrease) in cash 42,702,328 (24,751,888) 49,502,733
Cash at beginning of period 6,800,405 39,042,884 --
------------ ----------- ------------
Cash at end of period $ 49,502,733 14,290,996 49,502,733
============ =========== ============
Supplemental schedule of noncash financing activities:
Exercise of stock option, 5,000 shares in exchange for
1,717 treasury shares. $ -- -- 25,393
See accompanying notes to financial statements and accountants' review report.
NORTHFIELD LABORATORIES INC.
(A COMPANY IN THE DEVELOPMENT STAGE)
NOTES TO FINANCIAL STATEMENTS
FEBRUARY 28, 2006
(UNAUDITED)
(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, results of operations and cash
flows for the interim periods presented. The results of operations for the
interim periods presented are not necessarily indicative of the results to be
expected for the full fiscal years. The interim financial statements should be
read in connection with the audited financial statements for the year ended May
31, 2005.
(2) USE OF ESTIMATES
Our management has made a number of estimates and assumptions relating to the
reporting of assets and liabilities and the disclosure of contingent assets and
liabilities to prepare these financial statements in conformity with accounting
principles generally accepted in the United States of America. Actual results
could differ from those estimates.
(3) 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 we reported net losses for all periods presented,
basic and diluted per share amounts are the same. As of February 28, 2006, we
have 1,758,375 options and 212,392 warrants that were excluded from the net loss
per share calculation because their inclusion would have been anti-dilutive.
(4) STOCK OPTIONS
We account for our fixed plan stock options under the intrinsic value method of
accounting prescribed by Accounting Principles Board Opinion No. 25, "Accounting
for Stock Issued to Employees", and related interpretations in accounting for
options granted to directors, officers, and key employees under the plans. As
such, compensation expense is recorded on the date of grant and amortized over
the period of service only if the current market value of the underlying stock
exceeded the exercise price. No stock option based employee compensation cost is
reflected in net loss, as each option granted under these plans had an exercise
price equal to the market value of the underlying common stock on the date of
grant.
The following table illustrates the effect on net loss if we had applied the
fair value recognition provisions of Statement of Financial Accounting Standards
(SFAS) No. 123, "Accounting for Stock Based Compensation" to the measurement of
stock-based employee compensation,
including a straight-line recognition of compensation costs over the related
vesting periods for fixed awards:
Three Months Ended Nine Months Ended
--------------------------- ---------------------------
February 28, February 28, February 28, February 28,
2006 2005 2006 2005
------------ ------------ ------------ ------------
(unaudited) (unaudited) (unaudited) (unaudited)
Net loss as reported $(6,394,958) (4,847,578) (18,444,796) (14,646,246)
Add: Stock based compensation
expense included in statements
of operations 35,818 32,346 191,588 164,055
Deduct: Total stock based
compensation expense
determined under the fair
value method for all awards (604,259) (507,347) (2,304,112) (1,400,648)
----------- ---------- ----------- -----------
(6,963,399) (5,322,579) (20,557,320) (15,882,839)
Basic and diluted loss per share:
As reported (0.24) (0.21) (0.69) (0.67)
Pro forma (0.26) (0.23) (0.77) (0.73)
=========== ========== =========== ===========
The weighted-average fair value of options granted during the periods ended
February 28, 2006 and 2005 were $8.95 and $13.43 respectively.
For purposes of calculating the compensation cost consistent with SFAS 123,
the fair value of each option grant is estimated using the Black-Scholes
option-pricing model with the following weighted-average assumptions used for
grants in the periods ended February 28, 2006 and 2005:
FEBRUARY 28, FEBRUARY 28,
2006 2005
------------ ------------
Expected volatility ...... 71.5% 72.3%
Risk-free interest rate .. 4.4% 3.9%
Dividend yield ........... -- --
Expected lives ........... 7.0 years 7.6 years
========= =========
(5) RECENTLY ISSUED ACCOUNTING STANDARD
In December 2004, Statement of Financial Accounting Standards (SFAS) No. 123
(Revised 2004), "Share-Based Payment: an amendment of FASB Statements No. 123
and 95", was issued. This Statement amends SFAS No. 123, "Accounting for
Stock-Based Compensation", and requires companies to recognize in the income
statement the grant-date fair value of stock options and other equity-based
compensation issued to employees. The Statement is effective for public
companies with annual periods beginning after June 15, 2005. The Company will
adopt SFAS
123(R) for the three-month period ending August 31, 2006. The Company will
assess the impact of the transition to this new accounting standard during the
upcoming months.
(6) MARKETABLE SECURITIES
The Company, at February 28, 2006, is invested in high grade commercial
paper. The Company has the intent and ability to hold these securities until
maturity and all securities have a maturity of less than one year.
The fair market value of the Company's marketable securities was
$30,809,703 at February 28, 2006, which included gross unrealized holding losses
of $378. The fair market value of the Company's marketable securities was
$91,209,903 at May 31, 2005, which included gross unrealized holding losses of
$120,386. All of these marketable securities are scheduled to mature in less
than one year.
(7) LEGAL PROCEEDINGS
Subsequent to the end of the Company's fiscal third quarter, the Company
and its chief executive officer were named as defendants in purported class
action lawsuits pending before the federal District Court for the Northern
District of Illinois alleging various violations of the federal securities laws.
These lawsuits allege, among other matters, that the Company failed to
adequately disclose information regarding the results from a clinical trial of
its PolyHeme product in elective surgery that was conducted from 1998 to 2001.
Although the Company believes these lawsuits lack merit, the lawsuits are at an
early stage and it is not possible at this time to predict the outcome of any of
the matters or their potential effect, if any, on the Company or the clinical
development or future commercialization of its PolyHeme product.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS.
RECENT DEVELOPMENTS
We are currently enrolling patients in a pivotal Phase III trial in which
our PolyHeme(R) hemoglobin-based oxygen-carrying resuscitative fluid is being
used for the first time in the U.S. to treat severely injured patients in
hemorrhagic shock before they reach the hospital. Under this protocol, treatment
with PolyHeme begins at the scene of the injury or in the ambulance and
continues during transport and the initial 12-hour post-injury period in the
hospital. Since blood is not presently carried in ambulances, the use of
PolyHeme in this setting has the potential to improve survival and address a
critical, unmet medical need.
Twenty-seven of the 32 clinical sites that have received Institutional
Review Board, or IRB, approval to participate in our pivotal Phase III trial are
enrolling patients in the trial. Thirty-one of these sites have initiated
enrollment and the last is scheduled to open in April 2006. Three sites have
suspended enrollment of patients in order to review their participation in the
trial, and one site has suspended enrollment pending additional retraining. This
review follows recent media reports that have challenged certain aspects of the
design of our trial and the adequacy of the community consultation process
conducted by clinical sites in connection with the trial. A number of other
trial sites have conducted similar reviews and have already resumed their
enrollment of patients in our trial.
Each of the sites participating in the trial is designated as a Level I
trauma center, indicating its capacity to treat the most severely injured trauma
patients. The trial has an expected enrollment of 720 patients.
As part of our trial protocol, an Independent Data Monitoring Committee, or
IDMC, is responsible for periodically evaluating the safety data from the trial
and making recommendations relating to the continuation or modification of the
trial protocol to minimize any identified risks to patients. The IDMC has
completed four separate evaluations after 60, 120, 250 and 500 patients were
enrolled in our trial and monitored for a 30-day follow up period. The IDMC has
stated that it observed no statistically significant trends or safety issues
that would warrant modification or other changes in our current trial protocol
or patient recruitment. Based on these observations, the IDMC has recommended
that our trial continue to completion without modification. We will not have
access to the trial data reviewed by the IDMC until the trial is completed and
the database has been cleaned and locked by our contract research organization.
As of March 31, 2006, approximately 655 patients had been enrolled in our
pivotal Phase III trial. Our current goal is to complete the patient enrollment
phase in the second quarter of calendar year 2006. Our ability to achieve this
goal will depend, in part, on the number of clinical sites continuing to
participate in our trial and the ability of these sites to enroll patients at
the projected rates.
The progress of our pivotal Phase III trial and the timing and outcome of
the Food and Drug Administration, or FDA, review process are subject to
significant risks and uncertainties, many of which are outside of our control.
We urge you to review the "Risk Factors" section in our most recent Annual
Report on Form 10-K filed with the Securities and Exchange Commission for a
discussion of certain of these risks and uncertainties.
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. 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, 2006, we have incurred operating losses totaling
$163,806,000.
We will be required to complete our pivotal Phase III trial and obtain FDA
regulatory approval before PolyHeme can be sold commercially. The FDA regulatory
process is subject to significant risks and uncertainties, and we therefore
cannot at this time reasonably estimate the timing of any future revenues from
the commercial sale of PolyHeme. The costs incurred by Northfield to date and
during each period presented below in connection with our development of
PolyHeme are described in the Statements of Operations in our financial
statements.
Our success will depend on several factors, including our ability to obtain
FDA regulatory approval of PolyHeme and our manufacturing facilities, obtain
sufficient quantities of human red blood cells to manufacture PolyHeme in
commercial quantities, manufacture and distribute PolyHeme in a cost-effective
manner, enforce our patent positions and raise sufficient capital to fund these
activities. 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.
RESULTS OF OPERATIONS
We reported no revenues for either of the three and nine-month periods
ended February 28, 2006 or 2005. From Northfield's inception through February
28, 2006, 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, 2006
totaled $7,240,000, an increase of $2,111,000 from the $5,129,000 reported in
the third quarter of fiscal 2005. Measured on a percentage basis, third quarter
fiscal 2006 operating expenses exceeded third quarter fiscal 2005 expenses by
41.2%. As expected, significant increases in operating expenses were incurred to
conduct, expand, report and support our pivotal Phase III trial.
Research and development expenses during the third quarter of fiscal 2006
totaled $5,786,000, an increase of $1,968,000, or 51.5%, from the $3,818,000
reported in the third quarter of fiscal 2005. Our pivotal Phase III trial is
enrolling patients at 10 additional clinical sites compared to a year ago. Also
included in the current quarter research and development expenses was an
increased use of scientific and regulatory consultants to prepare for the
reporting of data from our trial to FDA.
General and administrative expenses in the third quarter of fiscal 2006
totaled $1,454,000, which is an increase of $143,000, or 10.9%, from the
$1,311,000 of general and administrative expenses reported in the third quarter
of fiscal 2005. The increased expenses in the third quarter of fiscal 2006
compared to the third quarter of fiscal year 2005 were due to increased
professional service fees, compensation accruals, insurance costs, and state
taxes determined by our capital structure. We anticipate potentially significant
general and administrative expense increases for the remainder of the fiscal
year. No new general and administrative programs are currently planned, as
successfully completing our pivotal Phase III trial remains our primary focus.
However, we anticipate potentially significant general and administrative
expense increases for the remainder of the fiscal year due primarily to the
proceedings discussed below.
Subsequent to the end of our fiscal third quarter, we received an informal
request from the staff of the Securities and Exchange Commission, or SEC, to
voluntarily provide certain information relating to the clinical development of
PolyHeme in elective surgery. We intend to cooperate with the SEC staff in
connection with its review of this information. We have also agreed to
voluntarily provide similar information to the staff of the Finance Committee of
the United States Senate. In addition, Northfield and our chief executive
officer were named as defendants in purported class action lawsuits alleging
violations of the federal securities laws relating to the disclosure of results
from a clinical trial of our PolyHeme product in elective surgery that was
conducted from 1998 to 2001. While we believe these lawsuits lack merit, each of
these matters is at an early stage and it is not possible at this time to
predict the outcome of any of the matters or their potential effect, if any, on
Northfield or the clinical development or future commercialization of our
PolyHeme product. See "Legal Proceedings." We anticipate significant future
increases in our general and administrative expenses resulting from professional
fees and expenses incurred in connection with these matters.
For the nine-month period ended February 28, 2006, operating expenses of
$20,756,000 exceeded the operating expenses of $15,203,000 incurred in the
nine-month period ended February 28, 2005. The dollar increase was $5,553,000
and the percentage increase equaled 36.5%. The increases are primarily
attributed to the planning, preparation, execution, analysis and reporting of
our pivotal Phase III trial.
Research and development expenses for the nine-month period ended February
28, 2006 totaled $16,454,000, which represents a $4,420,000, or 36.7%, increase
from the comparable expenses incurred in the nine-month period ended February
28, 2005. During the current fiscal year, increased expense totaling $2,676,000
was reported for clinical site activities and the direct costs of trial
monitoring, analysis and reporting. During the current fiscal year, the
organization has expanded by 10 net hires contributing to increased compensation
and recruiting costs. Also this fiscal year we are conducting additional work in
multiple areas to refresh and update our database in preparation for filing a
license application with FDA.
General and administrative expenses for the nine-month period ended
February 28, 2006 totaled $4,303,000, which is an increase of $1,133,000, or
35.7%, from the $3,170,000 of general and administrative expenses reported for
the nine-month period ended February 28, 2005. The increased expenses this
fiscal year are due to higher employment levels, increased compensation
accruals, higher professional services fees, primarily for legal and investor
relations, increased insurance costs and additional taxes payable based on our
increased market capitalization.
INTEREST INCOME
Interest income for the three-month period ended February 28, 2006 totaled
$845,000, an increase of $564,000 from the $281,000 in interest income reported
in the three-month period ended February 28, 2005. The increase in our interest
income is due to our improved cash position resulting from our successful equity
financing during February 2005 and higher short-term interest rates.
Interest income for the nine-month period ended February 28, 2006 totaled
$2,312,000, an increase of $1,755,000 from the $557,000 in interest income
reported in the nine-month period ended February 28, 2005. The increase in cash
balances and increases in available short-term interest rates caused interest
income to increase. We continue to invest our funds only in high grade,
short-term instruments.
NET LOSS
Our net loss for the three-month period ended February 28, 2006 totaled
$6,395,000, or $0.24 per share, compared to a net loss of $4,848,000, or $0.21
per share, for the three-month period ended February 28, 2005. In dollar terms,
the loss increased by $1,547,000 or 31.9%, primarily as a result of the
increased expenses relating to our pivotal Phase III trial.
On a fiscal year to date basis, we reported a loss of $18,445,000, or $0.69
per share, compared to a prior year nine-month loss of $14,646,000, or $0.67 per
share. The increased net loss of $3,799,000, or 25.9%, was primarily the result
of increased expenses relating to our pivotal Phase III trial during the first
nine-months of the current fiscal year.
LIQUIDITY AND CAPITAL RESOURCES
From Northfield's inception through February 28, 2006, we have used cash in
operating activities and for the purchase of property, plant, equipment and
engineering services in the amount of $160,874,000. For the nine-months ended
February 28, 2006 and February 28, 2005, these cash expenditures totaled
$19,240,000 and $14,540,000, respectively. The current fiscal year nine-month
increase in cash utilization is due primarily to increased expenses related to
our pivotal Phase III trial and professional service costs.
We have financed our research and development and other activities to date
through the public and private sale of equity securities and, to a more limited
extent, through the license of product rights. As of February 28, 2006, we had
cash and marketable securities totaling $80,313,000. As previously reported, we
have been successful in securing a $1.4 million federal appropriation as part of
the Defense Appropriation Bill in 2005 and a $3.5 million federal appropriation
as part of the Fiscal 2006 Defense Appropriation Bill. As of February 28, 2006,
we have not yet received these funds.
We are currently utilizing our cash resources at a rate of approximately
$28 million per year. We expect, however, that the rate at which we utilize of
our cash resources will significantly increase over the next two years as we
launch our planned commercial plant expansion and further expand our business
organization for product launch.
We anticipate that our expenditures for site monitoring and patient
enrollment in connection with our current Phase III clinical trial will be
completed in calendar 2006, while substantial additional costs will be incurred
during calendar 2006 to complete and submit a Biologics License Application for
PolyHeme with FDA. We also expect to incur additional expenses as we build
manufacturing, sales, marketing and distribution capabilities in support of the
commercialization of PolyHeme.
Based on our current estimates, we believe our existing capital resources
will be sufficient to permit us to conduct our operations, including the planned
expansion of our manufacturing, sales, marketing and distribution capabilities,
for approximately 15 to 18 months. Excluding the projected costs relating to our
planned expansion activities, we believe our existing capital resources would be
sufficient to permit us to conduct our operations, including completion of our
current Phase III clinical trial and the preparation and submission of a BLA to
FDA, for approximately 30 to 36 months.
We may in the future issue additional equity or debt securities or 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 are also pursuing potential sources of additional government funding.
Any one or a combination of these sources may be utilized to raise additional
capital. We believe our ability to raise additional capital or enter into a
collaborative arrangement with a strategic partner will depend primarily on the
results of our clinical trial, as well as general conditions in the business and
financial markets.
Our capital requirements may vary materially from those now anticipated
because of the timing and results of our clinical testing of PolyHeme, the
establishment of relationships with strategic partners, changes in the scale,
timing or cost of our planned commercial manufacturing facility, competitive and
technological advances, the FDA regulatory process, changes in our marketing and
distribution strategy and other factors.
CRITICAL ACCOUNTING POLICIES
The preparation of financial statements requires management to make
estimates and assumptions that affect amounts reported therein. We believe the
following critical accounting policy reflects our more significant judgments and
estimates used in the preparation of our financial statements.
NET DEFERRED TAX ASSETS VALUATION
We record our net deferred tax assets in the amount that we expect to
realize based on projected future taxable income. In assessing the
appropriateness of our valuation, assumptions and estimates are required, such
as our ability to generate future taxable income. In the event we were to
determine that it was more likely than not we would be able to realize our
deferred tax assets in the future in excess of their carrying value, an
adjustment to recognize the deferred tax assets would increase income in the
period such determination was made. As of February 28, 2006, we have recorded a
100% percent valuation allowance against our net deferred tax assets.
CONTRACTUAL OBLIGATIONS
The following table reflects a summary of our contractual cash obligations
as of February 28, 2006:
LESS THAN 4-5
Contractual Obligations TOTAL ONE YEAR 1-3 YEARS YEARS
----------------------- ---------- ---------- ---------- --------
Lease Obligations (1) .......... $2,866,402 $ 834,799 $1,788,683 $242,920
Other Obligations (2) .......... 1,300,000 1,300,000 -- --
---------- ---------- ---------- --------
Total Contractual Cash Oblig ... $4,166,402 $2,134,799 $1,788,683 $242,920
========== ========== ========== ========
----------
(1) The lease for our Evanston headquarters is cancelable with six months
notice combined with a termination payment equal to three months base rent
at any time after February 14, 2009. If the lease is cancelled as of
February 15, 2009 unamortized broker commissions of $17,470 would also be
due.
(2) Represents payments required to be made upon termination of employment
agreements with two of our executive officers. The employment contracts
renew automatically unless terminated. Figures shown represent compensation
payable upon the termination of the employment agreements for reasons other
than death, disability, cause or voluntary termination of employment by the
executive officer other than for good reason. Additional payments may be
required under the employment agreements in connection with a termination
of employment of the executive officers following a change in control of
Northfield.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We currently do not have any foreign currency exchange risk. We invest our
cash and cash equivalents in government securities, certificates of deposit and
money market funds. These investments are subject to interest rate risk.
However, due to the nature of our short-term investments, we believe that the
financial market risk exposure is not material. A one percentage point decrease
in the interest rate received on our cash and marketable securities of $80.3
million at February 28, 2006 would decrease interest income by $803,000 on an
annual basis.
ITEM 4. CONTROLS AND PROCEDURES.
Based on their evaluation as of the end of the period covered by this
report, our Chief Executive Officer and Senior Vice President and Chief
Financial Officer have concluded that Northfield's disclosure controls and
procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934, are effective to ensure that information required to be
disclosed by us in the reports that we file or submit under the Securities
Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission's rules and forms.
There were no changes in our internal control over financial reporting that
occurred during our most recent fiscal quarter that have materially affected, or
are reasonably likely to materially affect, our internal control over financial
reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
On March 13, 2006, Northfield received an informal request from the staff
of the SEC to voluntarily provide certain information relating to the clinical
development of PolyHeme in elective surgery. We intend to cooperate with the SEC
staff in connection with its review of this information. We have also agreed to
voluntarily provide similar information to the staff of the Finance Committee of
the United States Senate.
In addition, Northfield and our chief executive officer have been named as
defendants in purported class action lawsuits pending before the federal
District Court for the Northern District of Illinois alleging various violations
of the federal securities laws. These lawsuits allege, among other matters, that
Northfield failed to adequately disclose information regarding the results from
a clinical trial of our PolyHeme product in elective surgery that was conducted
from 1998 to 2001.
While we believe these lawsuits lack merit, each of these matters is at an
early stage and it is not possible at this time to predict the outcome of any of
the matters or their potential effect, if any, on Northfield or the clinical
development or future commercialization of our PolyHeme product.
ITEM 6. EXHIBITS
a) Exhibit 15 - Letter RE: unaudited interim financial information
Exhibit 31.1 - Certification of Steven A. Gould, M.D., pursuant to
Rule 13a-14(a) under the Securities Exchange Act of
1934
Exhibit 31.2 - Certification of Jack J. Kogut, pursuant to Rule
13a-14(a) under the Securities Exchange Act of 1934
Exhibit 32.1 - Certification of Steven A. Gould, M.D., pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
Exhibit 32.2 - Certification of Jack J. Kogut, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
b) None
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of the Company
in the capacities indicated on April 10, 2006.
SIGNATURE TITLE
--------- -----
/s/ Steven A. Gould, M.D. Chairman of the Board and Chief
------------------------------------- Executive Officer
Steven A. Gould, M.D.
/s/ Jack J. Kogut Sr. Vice President and Chief
------------------------------------- Financial Officer
Jack J. Kogut