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 June 30, 2007
( ) 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 001-32287
Samaritan Pharmaceuticals, Inc.
(Exact name of registrant as specified in charter)
Nevada 88-0431538
(State or other jurisdiction of (I.R.S. Employer Identification No.)
Incorporation or organization)
101 Convention Center Drive, Suite 310, Las Vegas, Nevada 89109
(Address of principal executive offices) (Zip)
(702) 735-7001
Issuer's telephone number, including area code
Former Name, Former Address and Former Fiscal Year, if changed Since Last Report
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934, as
amended, during the preceding twelve (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.
Large accelerated filer [ ] Accelerated filer [ ] Non-accelerated filer [x]
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act). Yes[ ] No[x]
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[x] No[ ]
The number of shares of common stock issued and outstanding as of August 13,
2007 was 27,711,200.
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Page No.
Item 1. Consolidated Financial Statements:
Consolidated Balance Sheets as of June 30, 2007 and
December 31, 2006.........................................................3
Consolidated Statements of Operations for the period
from Inception (September 5, 1994) to June 30, 2007,
and for the Three (3) Months and Six (6) Months Ended
June 30, 2007 and 2006....................................................4
Consolidated Statements of Shareholder's Equity (Deficit)
for the period from Inception (September 5, 1994) to
June 30, 2007.............................................................5
Consolidated Statements of Cash Flows for the period from
Inception (September 5, 1994) to June 30, 2007 and for the
Six (6) Months Ended June 30, 2007 and 2006...............................9
Notes to Interim Consolidated Financial Statements.......................10
Item 2. Management's Discussion and Analysis and Plan of
Operation................................................................20
Item 3. Quantitative and Qualitative Disclosures about Market Risk.......29
Item 4. Controls and Procedures.........................................31
PART II. OTHER INFORMATION
Item 1. Legal Proceedings................................................32
Item 1A. Risk Factors....................................................32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds......41
Item 3. Defaults Upon Senior Securities..................................41
Item 4. Submission of Matters to a Vote of Security Holders..............41
Item 5. Other Information................................................41
Item 6. Exhibits.........................................................42
Signatures
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
As of June 30, 2007 (unaudited) and December 31, 2006 (audited)
ASSETS
6/30/2007 12/31/2006
-------------------- ------------------
CURRENT ASSETS:
Cash and cash equivalents $ 393,659 $ 742,075
Inventory, pharmaceutical product 119,699 -
Receivable from license collaberation 1,301,742 -
Receivable from overseas product sales 408,657 -
Note receivable 250,000 250,000
Interest receivable 85,973 71,096
Prepaid expenses 438,416 10,750
-------------------- ------------------
TOTAL CURRENT ASSETS 2,998,146 1,073,921
PROPERTY AND EQUIPMENT 92,662 127,627
-------------------- ------------------
OTHER ASSETS:
Patent registration costs 1,263,937 1,042,791
Purchased technology rights 238,574 252,349
Deposits 2,779 2,779
-------------------- ------------------
TOTAL OTHER ASSETS 1,505,290 1,297,919
-------------------- ------------------
$ 4,596,098 $ 2,499,467
==================== ==================
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 650,628 $ 414,237
Accrued expenses 785,226 515,271
Accounts payable to be settled through issuance
of stock - 590,057
-------------------- ------------------
TOTAL CURRENT LIABILITIES 1,435,854 1,519,565
-------------------- ------------------
SHAREHOLDERS' EQUITY:
Preferred stock, 5,000,000 shares authorized at $.001
par value, -0- issued and outstanding - -
Common stock, 41,666,667 shares authorized at $.001
par value, 27,709,577 and 26,108,785
issued and outstanding 27,710 26,109
Additional paid-in capital 44,299,215 42,225,080
Common stock to be issued - 231,502
Treasury stock (250,248) (250,248)
Accumulated other comprehensive income 44,056 56,601
Accumulated deficit during development stage (40,960,489) (41,309,142)
-------------------- ------------------
TOTAL SHAREHOLDERS' EQUITY 3,160,244 979,902
-------------------- ------------------
$ 4,596,098 $ 2,499,467
==================== ==================
See accompanying notes to the consolidated financial statements (unaudited)
3
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS & COMPREHENSIVE INCOME
(UNAUDITED)
FROM INCEPTION (SEPTEMBER 5, 1994) TO JUNE 30, 2007
AND FOR THE THREE MONTHS AND SIX MONTHS ENDED JUNE 30, 2007 AND 2006
For the Six Months For the Three Months
From Sep. 5, 1994 June 30 June 30
To --------------------------------- -------------------------------
June 30, 2007 2007 2006 2007 2006
-------------------- --------------- --------------- -------------- ---------------
(Unaudited) (Unaudited) (Unaudited) (Unaudited) (Unaudited)
REVENUES:
Pharmaceutical sales $ 408,811 $ 408,811 $ - $ 408,811 $ -
Licensing rights 2,701,742 2,701,742 - - -
Consulting 300,000 - - - -
Government research grants 289,226 - 21,793 - -
-------------------- --------------- --------------- -------------- ---------------
3,699,779 3,110,553 21,793 408,811 -
-------------------- --------------- --------------- -------------- ---------------
EXPENSES:
Cost of goods sold 287,835 287,835 - 287,835 -
Research and development 15,378,460 971,636 2,099,709 554,113 1,510,490
Interest, net (93,589) (15,049) (16,527) (7,595) (7,561)
General and administrative 27,963,721 1,427,389 1,316,743 759,978 719,591
Depreciation and amortization 1,492,971 90,089 69,822 46,453 35,035
Other income (369,130) - 3,160 - -
-------------------- --------------- --------------- -------------- ---------------
44,660,268 2,761,900 3,472,907 1,640,784 2,257,555
-------------------- --------------- --------------- -------------- ---------------
NET INCOME (LOSS) (40,960,489) 348,653 (3,451,114) (1,231,973) (2,257,555)
Other Comprehensive Income (Loss):
Unrealized gain on marketable securities - - 3,933 - 0
Foreign translation adjustment 44,056 (12,545) 43,740 7,377 43,620
-------------------- --------------- --------------- -------------- ---------------
Total Comprehensive Loss $ (40,916,433) $ 336,108 $ (3,403,441) $ (1,224,596) $ (2,213,935)
==================== =============== =============== ============== ===============
Loss (earnings) per share
Basic $ 0.01 $ (0.15) $ (0.05) $ (0.09)
=============== =============== ============== ===============
Diluted $ 0.01 $ (0.15) $ (0.05) $ (0.09)
=============== =============== ============== ===============
Weighted average number of shares outstanding:
Basic 26,583,618 23,398,262 26,994,549 23,922,100
=============== =============== ============== ===============
Diluted 26,583,618 23,398,262 26,994,549 23,922,100
=============== =============== ============== ===============
See accompanying notes to the consolidated financial statements (unaudited)
4
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
FROM INCEPTION (SEPTEMBER 5, 1994) TO June 30, 2007
Shares
Number Par Value Reserved Additional Common
of Common for Paid in Stock to
Shares Stock Conversion Capital be issued Warrants
------------- ---------- ---------- ------------ ----------- -----------
Inception at September 5, 1994 - $ - $ - $ - $ - $ -
Shares issued for cash, net of
offering costs 1,014,231 1,014 - 635,076 - -
Warrants issued for cash - - - - - 5,000
Shares issued as compensation
for services 119,083 119 - 1,428,881 - -
Net loss - - - - - -
------------- ---------- ---------- ------------ ----------- -----------
December 31, 1996 (Unaudited) 1,133,314 1,133 - 2,063,957 - 5,000
Issuance of stock, prior to
acquisition 34,392 34 - 371,121 - -
Acquisition of subsidiary for stock 250,500 251 - 46,445 - -
Shares of parent redeemed, par
value $.0001 (1,418,206) (1,418) - 1,418 - -
Shares of public subsidiary
issued, par value $.001 1,281,615 1,282 820 (2,102) - -
Net loss - - - - - -
------------- ---------- ---------- ------------ ----------- -----------
December 31, 1997 (Audited) 1,281,615 1,282 820 2,480,838 - 5,000
Conversion of parent's shares 116,004 116 (696) 580 - -
Shares issued for cash, net of
offering costs 115,583 116 - 605,763 - -
Shares issued in cancellation of debt 87,500 88 - 524,913 - -
Shares issued as compensation 66,667 67 - 349,933 - -
Net loss - - - - - -
------------- ---------- ---------- ------------ ----------- -----------
December 31, 1998 (Audited) 1,667,369 1,667 124 3,962,027 - 5,000
Conversion of parent's shares 2,167 2 (13) 11 - -
Shares issued in cancellation of debt 5,000 5 - 29,995 - -
Shares issued for cash, net of
offering costs 7,500 8 - 41,405 - -
Shares issued as compensation 594,875 595 - 465,087 - -
Detachable warrants issued - - - - - 152,125
Detachable warrants exercised 16,667 17 - 148,983 - (149,000)
Debentures converted to stock 280,408 280 - 641,840 - -
Net loss - - - - - -
------------- ---------- ---------- ------------ ----------- -----------
December 31, 1999 (Audited) 2,573,985 2,574 111 5,289,348 - 8,125
Conversion of parent's shares 21,492 21 (111) 90 - -
Shares issued for cash, net of
offering costs 262,532 263 - 859,772 - -
Shares issued in cancellation of debt 145,833 146 - 661,648 - -
Shares issued in cancellation
of accounts payable 16,667 17 - 31,248 - -
Shares issued as compensation 563,158 562 - 2,557,905 - -
Warrants exercised 6,468 6 - 3,119 - (3,125)
Warrants expired - - - 5,000 - (5,000)
Net loss - - - - - -
------------ --------- --------- ------------ ----------- -----------
December 31, 2000 (Audited) 3,589,135 3,589 - 9,408,129 - -
Shares issued for cash, net of
offering cost 1,082,848 1,083 - 1,263,172 - -
Shares issued as compensation 1,527,033 1,527 - 1,566,234 - -
Shares issued for previously
purchased shares 57,101 57 - 188,493 - -
Shares issued in cancellation
of accounts payable 33,333 33 - 69,047 - -
Amortization of deferred compensation - - - - - -
Stock options issued for services - - - 439,544 - -
Net loss - - - - - -
------------ ---------- -------- ------------ ----------- ------------
December 31, 2001 (Audited) 6,289,450 6,289 - 12,934,619 - -
See accompanying notes to the consolidated financial statements (unaudited)
5
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
FROM INCEPTION (SEPTEMBER 5, 1994) TO June 30, 2007
CONTINUED
Accumulated
Other Stock Total
Deferred Comprehensive Subscriptions Treasury Accumulated Shareholders'
Compensation Income Receivable Shares Deficit Deficit
------------- ------------ ------------ ----------- ------------- ---------------
Inception at September 5, 1994 $ - - $ - $ - $ - $ -
Shares issued for cash, net of
offering costs - - - - - 636,090
Warrants issued for cash - - - - - 5,000
Shares issued as compensation
for services - - - - - 1,429,000
Net loss - - - - (2,152,843) (2,152,843)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 1996 (Unaudited) - - - - (2,152,843) (82,753)
Issuance of stock, prior to
acquisition - - - - - 371,155
Acquisition of subsidiary for stock - - - - - 46,695
Shares of parent redeemed,
par value $.0001 - - - - - -
Shares of public subsidiary
issued, par value $.001 - - - - - -
Net loss - - - - (979,635) (979,635)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 1997 (Audited) - - - - (3,132,478) (644,538)
Conversion of parent's shares - - - - - -
Shares issued for cash, net
of offering costs - - - - - 605,879
Shares issued in cancellation of debt - - - - - 525,000
Shares issued as compensation - - - - - 350,000
Net loss - - - - (1,009,945) (1,009,945)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 1998 (Audited) - - - - (4,142,423) (173,604)
Conversion of parent's shares - - - - - -
Shares issued in cancellation of debt - - - - - 30,000
Shares issued for cash, net of
offering costs - - - - - 41,412
Shares issued as compensation - - - - - 465,682
Detachable warrants issued - - - - - 152,125
Detachable warrants exercised - - - - - -
Debentures converted to stock - - - - - 642,120
Net loss - - - - (1,671,255) (1,671,255)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 1999 (Audited) - - - - (5,813,678) (513,520)
Conversion of parent's shares - - - - - -
Shares issued for cash, net of
offering costs - - - - - 860,035
Shares issued in cancellation of debt - - - - - 661,794
Shares issued in cancellation
of accounts payable - - - - - 31,265
Shares issued as compensation (759,560) - - - - 1,798,907
Warrants exercised - - - - - -
Warrants expired - - - - - -
Net loss - - - - (3,843,308) (3,843,308)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 2000 (Audited) (759,560) - - - (9,656,986) (1,004,827)
Shares issued for cash, net
of offering costs - - - - - 1,264,255
Shares issued as compensation (230,512) - - - - 1,337,249
Shares issued for previously
purchased shares - - - - - 188,550
Shares issued in cancellation
of accounts payable - - - - - 69,080
Amortization of deferred compensation 495,036 - - - - 495,036
Stock options issued for services - - - - - 439,544
Net loss - - - - (4,079,806) (4,079,806)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 2001 (Audited) (495,036) - - - (13,736,792) (1,290,919)
See accompanying notes to the consolidated financial statements (unaudited)
6
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
FROM INCEPTION (SEPTEMBER 5, 1994) TO June 30, 2007
CONTINUED
Shares
Number Par Value Reserved Additional Common
of Common for Paid in Stock to
Shares Stock Conversion Capital be issued Warrants
------------- ---------- ---------- ------------ ----------- -----------
Shares issued for cash, net of
offering costs 3,109,583 3,110 - 2,093,189 - -
Shares issued as compensation 640,088 640 - 1,047,386 - -
Shares issued for previously
purchased shares 8,333 8 - 4,992 - -
Shares issued in cancellation
of accounts payable 710,864 711 - 542,845 - -
Amortization of deferred compensation - - - - - -
Stock options issued for services - - - 225,000 - -
Net loss - - - - - -
------------ ---------- --------- ------------ ----------- -----------
December 31, 2002 (Audited) 10,758,318 10,758 - 16,848,031 - -
Shares issued for cash, net of
offering costs 2,915,611 2,916 - 2,406,873 - -
Shares issued as compensation 677,139 677 - 553,165 - -
Shares issued for previously
purchased shares 193,452 193 - 162,307 - -
Shares issued in cancellation
of accounts payable and
accrued compensation 1,602,645 1,603 - 3,456,963 - -
Shares issued in connection
with equity financing 520,833 521 - (521) - -
Exercise of stock options 1,295,149 1,295 - 1,118,553 - -
Shares reacquired in settlement
of judgement (260,675) (261) - 250,509 - -
Stock options issued for services - - - 145,000 - -
Net loss - - - - - -
------------ ---------- --------- ------------ ----------- -----------
December 31, 2003 (Audited) 17,702,472 17,702 - 24,940,880 - -
Shares issued for cash, net
of offering costs 1,904,456 1,904 - 4,299,034 - -
Shares issued as compensation,
expensed 346,875 347 - 1,790,131 - -
Amortization of deferred compensation - - - - - -
Shares issued for previously
purchased shares 13,889 14 - 12,486 - -
Exercise of stock options 2,825,078 2,825 - 4,855,995 - -
Exercise of warrants 105,833 106 - 449,894 - -
Shares issued in connection
with equity financing 1,459,707 1,460 - 3,098,541 - -
Stock retired in settlement of
subscriptions receivable (2,311,609) (2,312) - (5,976,356) - -
Shares reacquired in settlement
of judgement (41,667) (42) - (231,308) - -
Stock options issued for services - - - 567,771 - -
Other comprehensive income (loss) - - - - - -
Net Loss - - - - - -
------------ ---------- --------- ------------ ----------- -----------
December 31, 2004 (Audited) 22,005,033 22,005 - 33,807,068 - -
Shares issued as compensation,
expensed 66,483 66 - 197,117 - -
Amortization of deferred compensation - - - - - -
Exercise of stock options 28,333 28 - 31,472 - -
Shares issued in connection
with equity financing 711,196 711 - 1,603,029 - -
Stock options issued for services - - - 65,052 - -
Other comprehensive income (loss) - - - - - -
Net loss - - - - - -
------------ ---------- --------- ------------ ----------- -----------
December 31, 2005 (Audited) 22,811,046 22,811 - 35,703,738 - -
Shares issued for cash, net of
offering cost 1,202,083 1,202 - 2,043,798 - -
Common stock to be issued - - - - 231,502 -
Amortization of deferred compensation - - - - - -
Exercise of stock options 75,154 75 - 64,425 - -
Shares issued in connection with
equity financing 2,020,501 2,021 - 4,192,753 - -
Stock options issued for services - - - 220,366 - -
Other comprehensive income (loss) - - - - - -
Net loss - - - - - -
------------ ---------- --------- ------------ ----------- -----------
December 31, 2006 (Audited) 26,108,785 26,109 - 42,225,080 231,502 -
Common stock to be issued - - - - 568,748 -
Shares issued for cash, net of
offering costs 889,167 889 - 799,361 (800,250) -
Shares issued in cancellation of
accounts payable 391,625 392 - 747,169 - -
Shares issued in connection with
equity financing 320,000 320 - 479,680 - -
Stock options issued for services - - - 47,925 - -
Other comprehensive income (loss) - - - - - -
Net income - - - - - -
------------ ---------- --------- ------------ ----------- -----------
June 30, 2007 (Unaudited) 27,709,577 $ 27,710 $ - $44,299,215 $ - $ -
============ ========== ========= ============ =========== ===========
See accompanying notes to the consolidated financial statements (unaudited)
7
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY (DEFICIT)
FROM INCEPTION (SEPTEMBER 5, 1994) TO June 30, 2007
CONTINUED
Accumulated
Other Stock Total
Deferred Comprehensive Subscriptions Treasury Accumulated Shareholders'
Compensation Income Receivable Shares Deficit Deficit
------------- ------------ ------------ ----------- ------------- ---------------
Shares issued for cash, net
of offering costs - - - - - 2,096,299
Shares issued as compensation - - - - - 1,048,026
Shares issued for previously
purchased shares - - - - - 5,000
Shares issued in cancellation
of accounts payable - - - - - 543,556
Amortization of deferred compensation 495,036 - - - - 495,036
Stock options issued for services - - - - - 225,000
Net loss - - - - (4,057,153) (4,057,153)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 2002 (Audited) - - - - (17,793,945) (935,155)
Shares issued for cash, net of
offering costs - - - - - 2,409,789
Shares issued as compensation - - - - - 553,842
Shares issued for previously
purchased shares - - - - - 162,500
Shares issued in cancellation
of accounts payable and
accrued compensation - - - - - 3,458,566
Shares issued in connection
with equity financing - - - - - -
Exercise of stock options - - (1,119,848) - - -
Shares reacquired in settlement
of judgement - - - (250,248) - -
Stock options issued for services - - - - - 145,000
Net loss - - - - (5,520,531) (5,520,531)
------------ ------------- ------------ ----------- ------------- ---------------
December 31, 2003 (Audited) - - (1,119,848) (250,248) (23,314,476) 274,011
Shares issued for cash, net
of offering costs - - - - - 4,300,938
Shares issued as compensation,
expensed (544,416) - - - - 1,246,062
Amortization of deferred compensation 240,000 - - - - 240,000
Shares issued for previously
purchased shares - - - - - 12,500
Exercise of stock options - - (4,858,820) - - -
Exercise of warrants - - - - - 450,000
Shares issued in connection
with equity financing - - - - - 3,100,001
Stock retired in settlement of
subscriptions receivable - - 5,978,668 - - -
Shares reacquired in settlement
of judgement - - - - - (231,350)
Stock options issued for services - - - - - 567,771
Other comprehensive income (loss) - (16,580) - - - (16,580)
Net Loss - - - - (4,864,361) (4,864,361)
------------ ------------- ----------- ---------- ------------ ----------------
December 31, 2004 (Audited) (304,416) (16,580) - (250,248) (28,178,837) 5,078,992
Shares issued as compensation,
expensed (128,034) - - - - 69,150
Amortization of deferred compensation 392,416 - - - - 392,416
Exercise of stock options - - - - - 31,500
Shares issued in connection
with equity financing - - - - - 1,603,740
Stock options issued for services - - - - - 65,052
Other comprehensive income (loss) - (7,892) - - - (7,892)
Net loss - - - - (5,557,559) (5,557,559)
------------ ------------ ----------- ---------- ------------ ----------------
December 31, 2005 (Audited) (40,034) (24,472) - (250,248) (33,736,396) 1,675,399
Shares issued for cash, net of
offering cost - - - - - 2,045,000
Common stock to be issued - - - - - 231,502
Amortization of deferred compensation 40,034 - - - - 40,034
Exercise of stock options - - - - - 64,500
Shares issued in connection with
equity financing - - - - - 4,194,774
Stock options issued for services - - - - - 220,366
Other comprehensive income (loss) - 81,073 - - - 81,073
Net loss - - - - (7,572,746) (7,572,746)
------------ ------------ ----------- ---------- ------------ ----------------
December 31, 2006 (Audited) - 56,601 - (250,248) (41,309,142) 979 902
Common stock to be issued - - - - - 568,748
Shares issued for cash, net of
offering costs - - - - - -
Shares issued in cancellation of
accounts payable - - - - - 747,561
Shares issued in connection with
equity financing - - - - - 480,000
Stock options issued for services - - - - - 47,925
Other comprehensive income (loss) - (12,545) - - - (12,545)
Net income - - - - 348,653 348,653
------------ ------------ ----------- ---------- ------------ ----------------
June 30, 2007 (Unaudited) $ - $ 44,056 $ - $(250,248) $(40,960,489) $ 3,160,244
============ ============ =========== ========== ============ ================
See accompanying notes to the consolidated financial statements (unaudited)
8
SAMARITAN PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
FROM INCEPTION (SEPTEMBER 5, 1994) AND FOR THE SIX MONTHS
ENDED JUNE 30, 2007 AND 2006
From
Inception For the Six Months Ended
(09/05/1994) June 30
To ---------------------------------
CASH FLOWS FROM OPERATING ACTIVITIES: June 30, 2007 2007 2006
-------------------- --------------- --------------
(Unaudited) (Unaudited) (Unaudited)
Net income (loss) $ (40,960,489) $ 348,653 $ (3,451,114)
Adjustments to reconcile net (loss) to net cash
used in operating activities:
Depreciation and amortization 1,492,971 90,089 69,822
Stock based compensation 9,659,280 - -
Stock options issued for services 1,710,658 47,925 -
Amortization of deferred compensation 1,662,522 - 40,034
Foreign currency (loss) gain 44,056 (12,545) 43,740
Other income (228,190) - 3,160
(Increase) decrease in assets:
Inventory (119,699) (119,699)
Accounts receivable (1,710,399) (1,710,399) 51,117
Interest receivable and prepaids (537,627) (442,541) (31,033)
Deposits 12,941 - -
Increase (decrease) in liabilities:
Deferred revenue - - -
Accounts payable and accrued expenses 3,844,728 663,848 26,431
-------------------- --------------- --------------
NET CASH USED IN OPERATING ACTIVITIES (25,129,248) (1,134,669) (3,247,843)
-------------------- --------------- --------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Organization costs, Samaritan Europe (4,243)
Purchase of technology rights (158,969) - -
Purchase of furniture and equipment (347,588) (3,927) (3,814)
Note receivable (250,000) - -
(Purchase) liquidation of marketable securities (3,160) - 496,840
Patent registration costs (1,400,506) (258,568) (36,643)
-------------------- --------------- --------------
NET CASH (USED IN) PROVIDED BY INVESTING ACTIVITIES (2,160,223) (262,495) 452,140
-------------------- --------------- --------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from warrants/options 703,125 - 64,500
Proceeds from debentures 642,120 - -
Proceeds from stock issued for cash 14,628,569 - 1,645,000
Proceeds from equity financing 9,378,516 480,000 2,308,514
Common stock to be issued 1,006,300 568,748 -
Short-term loan repayments (288,422) - -
Short-term loan proceeds 1,612,922 - -
-------------------- --------------- --------------
NET CASH PROVIDED BY FINANCING ACTIVITIES 27,683,130 1,048,748 4,018,014
-------------------- --------------- --------------
CHANGE IN CASH 393,659 (348,416) 1,222,311
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD - 742,075 456,463
-------------------- --------------- --------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 393,659 $ 393,659 $ 1,678,774
==================== =============== ==============
NON-CASH FINANCING AND INVESTING ACTIVITIES:
Purchase of net, non-cash assets of subsidiary
for stock $ 195 $ - $ -
Short-term debt retired through issuance
of stock $ 1,890,695 $ - $ -
Issuance of common stock, previously subscribed $ 180,000 $ - $ 46,259
Purchase of technology rights for accounts payable
to be settled through issuance of stock $ 199,500 $ - $ -
Treasury stock acquired through settlement
of judgement $ 250,248 $ - $ -
Stock subscriptions receivable $ 1,119,848 $ - $ -
Stock retired in settlement of subscriptions
receivable $ (5,978,668) $ - $ -
Stock received in settlement $ (231,350) $ - $ -
Stock as compensation for services $ 5,175,792 $ - $ -
Stock issued in cancellation of accounts payable $ 4,996,499 747,561 $ -
Exercise of stock options $ 4,858,820 $ - $ -
See accompanying notes to the consolidated financial statements (unaudited)
9
SAMARITAN PHARMACEUTICALS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2007 and 2006
(Unaudited)
NOTE 1 - BASIS OF PRESENTATION
The accompanying unaudited consolidated financial statements have been prepared
in accordance with generally accepted accounting principles for interim
financial statements and with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all the information and
disclosures required for annual financial statements. These consolidated
financial statements should be read in conjunction with the consolidated
financial statements and related footnotes for the year ended December 31, 2006,
included in the Form 10-K and form 10-K/A for the year then ended.
The financial information presented as of and for the three and six months ended
June 30, 2007 ("Q2 2007") and as of and for the three and six months ended June
30, 2006 ("Q2 2006") is unaudited. In the opinion of the Company's management,
all adjustments (consisting of normal recurring accruals) necessary to fairly
present the Company's financial position as of June 30, 2007, and the results of
operations and cash flows for the three (3) and six (6) month period ending June
30, 2007 have been included. The results of operations for the three (3) and six
(6) month period ended June 30, 2007 are not necessarily indicative of the
results to be expected for the full year ended December 31, 2007. For further
information, refer to the consolidated financial statements and footnotes
thereto included in the Company's Form 10-K/A as filed with the U.S. Securities
and Exchange Commission on April 27, 2007 for the year ended December 31, 2006.
On July 5, 2007, the Company's Board of Directors effected a one-for-six reverse
stock split of its common stock. The financial statements presented herein have
been restated to reflect the reverse stock split as if it had occurred at the
beginning of each period presented.
NOTE 2 - ORGANIZATION AND NATURE OF BUSINESS
Samaritan Pharmaceuticals, Inc. (the "Company") was formed in September 1994 and
became public in October 1997. Our principal executive offices are located in
Las Vegas, Nevada.
Samaritan Pharmaceuticals, Inc., is an entrepreneurial biopharmaceutical
pipeline company, focused on commercializing innovative therapeutic products to
relieve the suffering of patients with Alzheimer's disease; cancer;
cardiovascular disease, HIV, and Hepatitis C; as well as, commercializing its
acquired marketing and sales rights, to sell ten (10) marketed products, in
Greece, and/or various Eastern European countries.
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
A. Principles of Consolidation
The accompanying financial statements include the accounts of the Company and
its wholly owned subsidiaries. All intercompany balances and transactions have
been eliminated in consolidation.
B. Revenue recognition
The Company recognizes revenue in accordance with SEC Staff Accounting Bulletin
SAB 104, Topic 13, "Revenue Recognition" and Emerging Issues Task Force No.
00-21, or EITF 00-21, "Accounting for Revenue Arrangements with Multiple
Deliverables." Generally, the Company will not recognize revenue or establish a
receivable related to payments that are due greater than twelve months from the
balance sheet date. In all cases, revenue is only recognized after all of the
following four basic criteria of revenue recognition are met:
10
o Persuasive evidence of an arrangement exists;
o The fee is fixed or determinable;
o Collection is probable; and
o Delivery of technology or intellectual property rights has occurred or
services have been rendered.
Product Sales. Samaritan Pharmaceuticals sells Amphocil and Elaprase in Greece.
Product sales are recognized when delivery of the products has occurred, title
has passed to the customer, the selling price is fixed or determinable,
collectibility is reasonably assured and the Company has no further obligations.
The Company records allowances for product returns, rebates and wholesaler
chargebacks, wholesaler discounts, and prescription vouchers at the time of sale
and reports product sales net of such allowances. The Company must make
significant judgments in determining these allowances. As of June 30, 2007, the
Company has determined there is no need for an allowance for doubtful accounts.
If actual results differ from the Company's estimates, the Company will be
required to make adjustments to these allowances in the future.
License Revenue. The Company's license revenues are generated through an
agreement with a strategic partner. Nonrefundable, up-front license fees and
milestone payments with standalone value that are not dependent on any future
performance by us under the arrangements are recognized as revenue upon the
earlier of when payments are received or collections is assured, but are
deferred if we have continuing performance obligations. If we have continuing
involvement through contractual obligations under such agreement, such up-front
fees are deferred and recognized over the period for which we continue to have a
performance obligation, unless all of the following criteria exist: (1) the
delivered item(s) have standalone value to the customer, (2) there is objective
and reliable evidence of the fair value of the undelivered item(s). We also make
estimates and judgments when determining whether the collectibility of license
fees receivable from licensees is reasonably assured. We assess the
collectibility of accrued license fees based on a number of factors and if it is
determined that collection is not reasonably assured, the fee is recognized when
collectibility becomes reasonably assured, assuming all other revenue
recognition criteria have been met.
On March 28, 2007, Samaritan and Pharmaplaz Ltd ("Pharmaplaz"), a private Irish
Healthcare company and a shareholder of Samaritan, announced that they entered
into an agreement (the "Pharmaplaz Agreement") to commercialize SP-01A, an
"oral" HIV entry inhibitor. Currently, Pharmaplaz owns 943,292 common shares of
the Company, representing 3.4% of the total shares issued and outstanding. Under
the terms of the agreement, Pharmaplaz, a shareholder, is required to pay
Samaritan $10 million in upfront fees. The first payment of $1.4 million was
received on March 28, 2007, and the remaining $8.6 million is required to be
paid on September 16, 2007. Pharmaplaz, a shareholder, will pay for and be
responsible for future research and development to bring the technology to
market. Samaritan has no remaining obligations or performance for future
research and development. The $10,000,000 payment is non-refundable. Upon
request, Samaritan might occasionally advise Pharmaplaz regarding SP-01A, in
relationship to Principal Investigators with applications for NIH grants, or
other grant applications to advance SP-01A, at Pharmaplaz's cost. Samaritan and
Pharmaplaz will split 50/50 of all revenues stemming from SP-01A.
In the first quarter of 2007, Samaritan recognized as revenue $2,701,742 from
the Pharmaplaz Agreement, which is comprised of the $1,400,000 cash received and
$1,301,742 in receivable that Samaritan determined collectibility to be
reasonably assured. There was insufficient time prior to filing of this report
to perform necessary procedures to assure the collectibility of the remaining
balance due from Pharmaplaz on September 16, 2007. The remaining $7,298,258 will
be recognized as collectibility is assured or when the actual funds are
received.
Government Research Grant Revenue. The Company recognizes revenues from federal
government research grants during the period in which the related expenditures
are incurred.
11
C. Cash Equivalents
The Company considers all highly liquid temporary cash investments with an
original maturity of three months or less to be cash equivalents.
The Company maintains its cash in bank accounts at high credit quality financial
institutions. The balances at times may exceed federally insured limits.
D. Inventory
The Company's inventory consists primarily of pharmaceutical products for
distribution in our licensed territories. The Company values inventories at the
lower of cost or fair market value. The Company determines the cost of inventory
using the average cost method. The Company analyzes its inventory levels
quarterly and writes down inventory that has become obsolete, inventory that has
a cost basis in excess of its expected net realizable value and inventory
quantities in excess of expected requirements. Expired inventory is disposed of
and the related costs are written off and recognized as additional cost of
sales.
E. Concentration of Credit Risks
The Company is subject to concentrations of credit risk primarily in our
accounts receivable and investments in debt securities to the extent of the
amounts recorded on the balance sheet. The Company attempts to mitigate the
concentration of credit risk in their receivables through their credit
evaluation process, collection terms, sales to diverse end customers and through
geographical dispersion of sales. We generally do not require collateral for
receivables from our end customers or from distributors. In the event of
termination of a distributor agreement, inventory held by the distributor must
be returned.
F. Property and Equipment
Property and equipment are recorded at cost. Depreciation is provided using the
straight line method over the estimated useful lives of the assets.
G. Intangibles
Legal fees associated with filing patents are recorded at cost and amortized
over 17 years. The Company currently owns or in-licenses patents related to our
products or product candidates and owns or in-licenses additional applications
for patents that are currently pending. In general, when the Company in-licenses
intellectual property from various third parties, the Company is required to pay
royalties to the parties on product sales. The Company reviews patent costs for
impairment by comparing the carrying value of the patents with the fair value.
The Company believes it will recover the full amount of the patent costs based
on forecasts of sales of the products related to the patents. Patent
registration costs are amortized over seventeen (17) years once approved. Patent
amortization expense was $37,422 and $19,662 for the six months and three months
ended June 30, 2007. Amortization for the six months and three months ended June
30, 2006 was $21,904 and $11,079.
Projected amortization is $78,647 for 2007 through 2011. Certain U.S. patents
may be eligible for patent term extensions under the Hatch-Waxman Act and may be
available to Samaritan for the lost opportunity to market and sell the invention
during the regulatory review process.
Purchased technology rights are recorded at cost and are being amortized using
the straight line method over the estimated useful life of the technology,
fifteen (15) years. Amortization expense associated with these technology rights
was $13,775 and $7,345 for the six months and three months ended June 30, 2007.
Amortization for the six months and three months ended June 30, 2006 was $5,873
and $2,915. Projected amortization expense associated with these technology
rights in the future will be $25,720 for 2007 and $16,633 for 2008 through 2011.
12
H. Earnings (loss) per share
The Company reports earnings (loss) per common share in accordance with
Statement of Financial Accounting Standards ("SFAS") No. 128, "Earnings Per
Share." There were 4,303,944 and 4,135,586 outstanding options for June 30, 2007
and June 30, 2006 respectively, which were excluded from the earnings per share
calculation.
I. Use of Estimates
The preparation of financial statements in conformity with U.S. generally
accepted accounting principles requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenue and expenses during the reporting
period. Actual results could differ from those estimates.
J. Income Taxes
Pursuant to Statement of Financial Accounting Standards No. 109 ("SFAS 109")
Accounting for Income Taxes', the Company accounts for income taxes under the
liability method. Under the liability method, a deferred tax asset or liability
is determined based upon the tax effect of the differences between the financial
statement and tax basis of assets and liabilities as measured by the enacted
rates, which will be in effect when these differences reverse.
K. Research and Development Costs
Research and development costs are expensed when incurred. For the six (6) and
three (3) months ending June 30, 2007, research and development costs expensed
were $971,636 and $554,113, respectively. For the six (6) and three (3) months
ending June 30, 2006, research and development costs expensed were $2,099,709
and $1,510,490, respectively.
L. Impairment of Long-Lived Assets
The Company reviews long-lived assets and certain identifiable assets related to
those on a quarterly basis for impairment whenever circumstances and situations
change such that there is an indication that the carrying amounts may not be
recovered. At June 30, 2007, the Company does not believe that any impairment
has occurred.
M. Fair Value of Financial Instruments
Statement of Financial Accounting Standard No. 107, Disclosures about Fair Value
of Financial Instruments ("SFAS 107") requires the disclosure of fair value
information about financial instruments whether or not recognized on the balance
sheet, for which it is practicable to estimate the value. Where quoted market
prices are not readily available, fair values are based on quoted market prices
of comparable instruments. The carrying amount of cash, accounts payable and
accrued expenses approximates fair value because of the short maturity of those
instruments.
N. Foreign Currency Translation
Assets and liabilities of subsidiaries operating in foreign countries are
translated into U.S. dollars using both the exchange rate in effect at the
balance sheet date of historical rate, as applicable. Results of operations are
translated using the average exchange rates prevailing throughout the year. The
effects of exchange rate fluctuations on translating foreign currency assets and
liabilities into U.S. dollars are included in stockholders equity (Accumulated
other comprehensive loss), while gains and losses resulting from foreign
currency transactions are included in operations.
13
O. Stock Based Compensation
In December 2004, the FASB issued SFAS No. 123(R), "Share-Based Payment," which
replaces SFAS No. 123 and supersedes APB Opinion No. 25. Under SFAS No. 123(R),
companies are required to measure the compensation costs of share-based
compensation arrangements based on the grant-date fair value and recognize the
costs in the financial statements over the period during which employees are
required to provide services. Share-based compensation arrangements include
stock options, restricted share plans, performance-based awards, share
appreciation rights and employee share purchase plans. In March 2005 the SEC
issued Staff Accounting Bulletin No. 107, or "SAB 107". SAB 107 expresses views
of the staff regarding the interaction between SFAS No. 123(R) and certain SEC
rules and regulations and provides the staff's views regarding the valuation of
share-based payment arrangements for public companies. SFAS No. 123(R) permits
public companies to adopt its requirements using one of two methods. On April
14, 2005, the SEC adopted a new rule amending the compliance dates for SFAS No.
123(R). Companies may elect to apply this statement either prospectively, or on
a modified version of retrospective application under which financial statements
for prior periods are adjusted on a basis consistent with the pro forma
disclosures required for those periods under SFAS 123. Effective January 1,
2006, the Company has fully adopted the provisions of SFAS No. 123(R) and
related interpretations as provided by SAB 107. The Company utilizes the
Black-Scholes option-pricing model to calculate the fair value of each
individual issuance of options. Such compensation amounts, if any, are amortized
over the respective vesting periods of the option grant. The Company applies
this statement prospectively. Prior to January 1, 2006, the Company accounted
for stock-based employee compensation plans (including shares issued under its
stock option plans) in accordance with APB Opinion No. 25 and followed the pro
forma net income, pro forma income per share, and stock-based compensation plan
disclosure requirements set forth in the Statement of Financial Accounting
Standards No. 123, Accounting for Stock-Based Compensation ("SFAS No. 123").
P. Accrued Expenses
Accrued expenses consist of the unpaid portion of the respective officer's
contract salary.
Q. Common Stock To Be Issued
Common stock to be issued consists of proceeds from private placements received
by year-end or quarter-end for stock that has yet to be issued.
R. Prepaid Expenses and Other Assets
Total prepaid expenses of $438,416 consists of $336,964 of payments made in
preparation of a preclinical research project, $78,875 of consulting prepayments
and other miscellaneous prepayments of $22,576.
S. New Accounting Pronouncements
In March 2006, the FASB issued SFAS No. 156, "Accounting for Servicing of
Financial Assets, an amendment of FASB Statement No. 140, Accounting for
Transfers and Servicing of Financial Assets and Extinguishments of Liabilities".
This statement requires all separately recognized servicing assets and servicing
liabilities be initially measured at fair value, if practicable, and permits for
subsequent measurement using either fair value measurement with changes in fair
value reflected in earnings or the amortization and impairment requirements of
Statement No. 140. The subsequent measurement of separately recognized servicing
assets and servicing liabilities at fair value eliminates the necessity for
entities that manage the risks inherent in servicing assets and servicing
liabilities with derivatives to qualify for hedge accounting treatment and
eliminates the characterization of declines in fair value as impairments or
direct write-downs. SFAS No. 156 is effective for an entity's first fiscal year
beginning after September 15, 2006. The adoption of this statement did not have
a material impact on the Company's financial position or results of operations.
14
In July 2006, the Financial Accounting Standards Board (FASB) issued FASB
Interpretation (FIN) No. 48, "Accounting for Uncertainty in Income Taxes-an
interpretation of FASB Statement No. 109." This interpretation provides guidance
for recognizing and measuring uncertain tax positions, as defined in SFAS No.
109, "Accounting for Income Taxes." FIN No. 48 prescribes a threshold condition
that a tax position must meet for any of the benefit of an uncertain tax
position to be recognized in the financial statements. Guidance is also provided
regarding de-recognition, classification, and disclosure of uncertain tax
positions. FIN No. 48 is effective for fiscal years beginning after December 15,
2006. The Company does not expect that this interpretation will have a material
impact on its financial position, results of operations, or cash flows.
In September 2006, the FASB issued FASB Statement No. 157. This Statement
defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles (GAAP), and expands disclosures about
fair value measurements. This Statement applies under other accounting
pronouncements that require or permit fair value measurements, the Board having
previously concluded in those accounting pronouncements that fair value is a
relevant measurement attribute. Accordingly, this Statement does not require any
new fair value measurements. However, for some entities, the application of this
Statement will change current practices. This Statement is effective for
financial statements for fiscal years beginning after November 15, 2007. Earlier
application is permitted provided that the reporting entity has not yet issued
financial statements for that fiscal year. The adoption of FASB No. 157 did not
have a material impact on the financial statements of the Company.
In December 2006, the FASB approved FASB Staff Position (FSP) No. EITF 00-19-2,
"Accounting for Registration Payment Arrangements" ("FSP EITF 00-19-2"), which
specifies that the contingent obligation to make future payments or otherwise
transfer consideration under a registration payment arrangement, whether issued
as a separate agreement or included as a provision of a financial instrument or
other agreement, should be separately recognized and measured in accordance with
SFAS No. 5, "Accounting for Contingencies". FSP EITF 00-19-2 also requires
additional disclosure regarding the nature of any registration payment
arrangements, alternative settlement methods, the maximum potential amount of
consideration and the current carrying amount of the liability, if any. The
guidance in FSP EITF 00-19-2 amends FASB Statements No. 133, "Accounting for
Derivative Instruments and Hedging Activities", and No. 150, "Accounting for
Certain Financial Instruments with Characteristics of both Liabilities and
Equity", and FASB Interpretation No. 45, "Guarantor's Accounting and Disclosure
requirement for Guarantees, Including Indirect Guarantees of Indebtedness of
Others", to include scope exceptions for registration payment arrangements. FSP
EITF 00-19-2 is effective immediately for registration payment arrangements and
the financial instruments subject to those arrangements that are entered into or
modified subsequent to the issuance date of this FSP, or for financial
statements issued for fiscal years beginning after December 15, 2006, and
interim periods within those fiscal years, for registration payment arrangements
entered into prior to the issuance date of this FSP. The Company is currently
evaluating the impact, if any, on the Company's financial position, results of
operations or cash flows.
In February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities-including an amendment of FAS 115"
(Statement 159). Statement 159 allows entities to choose, at specified election
dates, to measure eligible financial assets and liabilities at fair value that
are not otherwise required to be measured at fair value. If a company elects the
fair value option for an eligible item, changes in that item's fair value in
subsequent reporting periods must be recognized in current earnings. Statement
159 is effective for fiscal years beginning after November 15, 2007. We are
currently evaluating the potential impact of Statement 159 on our financial
statements. We do not expect the impact will be material.
Other accounting standards that have been issued or proposed by the FASB or
other standards-setting bodies that do not require adoption until a future date
are not expected to have a material impact on the consolidated financial
statements upon adoption.
NOTE 4 - SHAREHOLDERS' EQUITY
On July 5, 2007, the Company's Board of Directors effected a one-for-six reverse
stock split of its common stock. The consolidated financial statements presented
herein have been restated to reflect the reverse stock split as if it had
occurred at the beginning of each period presented. All share and per share
information included in these consolidated financial statements has been
adjusted to reflect this reverse stock split. Currently, the Company has
41,666,667 shares of common stock and 5,000,000 shares of preferred stock
authorized.
15
A. Stock Option Plans.
The short and long-term compensation program includes stock options granted
under Stock Incentive Plans as well as non-qualified stock options. The Company
currently has two stock option plans: The 2005 Stock Option Plan, approved by
the shareholders on June 10, 2005 as an additional plan to the Company's 2001
Stock Plan; and the 2001 Stock Option Plan, approved by the shareholders on
April 24, 2001. Both option plans are designed to reward executives for
achieving long-term financial performance goals over a three-year to ten-year
period, provide retention incentives for executives, and tie a significant
portion of an executive's total compensation to long-term performance. Stock
options for executive officers and key associates are part of the incentive
program and link the enhancement of shareholder value directly to their total
compensation.
Shares available under the 2005 Plan: On a calendar year basis, Awards under the
Plan may be made for a maximum of ten percent (10%) of the total shares of
common stock outstanding on a fully diluted basis (without taking into account
outstanding Awards at the end of the prior calendar year), less Awards
outstanding at the end of the prior calendar year,less (ii) the number of shares
subject to outstanding awards at the close of business on that date.
Shares Available under the 2001 Plan: The number of awards that may be granted
under the 2001 Plan in each calendar year will not exceed twenty percent (20%)
of (i) the total shares of common stock outstanding on a fully diluted basis,
without taking into account awards outstanding under the 2001 Plan that are
exercisable for or convertible into common stock or that are unvested stock
awards (referred to as 'outstanding awards'), at the close of business on the
last day of the preceding calendar year, less (ii) the number of shares subject
to 'outstanding awards' at the close of business on that date.
The following table summarizes the Company's stock options outstanding at
December 31, 2006, and June 30, 2007:
Weighted average
Shares exercise price
--------- ----------------
Outstanding and exercisable at December 31, 2006 4,286,444 $3.79
Granted 42,500 1.80
Exercised 0 0
Expired (25,000) 4.30
--------- ----------------
Outstanding and exercisable at June 30, 2007 4,303,944 3.72
========= ================
Information, at date of issuance, regarding options for the quarter ended June
30, 2007 is as follows:
Weighted
Average Weighted
Exercise Average Fair
Shares Price Value
--------- --------- ---------
Exercise price exceeds market price 4,293,527 $3.72- -0-
Exercise price equals market price 10,417 $0.96 -0-
Exercise price is less than market price -0- $-0- -0-
16
The Company utilizes the Black-Scholes option-pricing model to calculate the
fair value of each individual issuance of options. There were 42,500 options
issued during the three months ended June 30, 2007. The per-share weighted
average fair value of stock options granted for compensation during the three
months ended June 30, 2007 and the year ended December 31, 2006 was $1.15 and
$4.56, respectively. On the date of grant, using the Black-Scholes pricing
model, the following assumptions were used for options granted during the three
(3) months ended June 30, 2007 and 2006:
June 30, 2007 June 30, 2006
Expected dividend yield 0% 0%
Risk-free interest rate 4.48% 5%
Volatility 88% 80%
At June 30, 2007, the range of exercise price for all of the Company's
outstanding stock options was $0.96 to $7.56, with an average remaining life of
5.5 years and an average exercise price of $3.72.
B. Stock as compensation and settlement of accounts payable:
The Company issues stock as compensation for services, valuing such issues
premised upon the fair market value of the stock.
During the quarter ended March 31, 2007, the Company issued an aggregate of
183,291 (1,099,748 pre stock split) shares of common stock in consideration of
services rendered to the Company during 2006. Such shares were valued at an
aggregate of $405,560. The Company also issued 83,333 shares (500,000 pre stock
split) for the acquisition of Metastatin Pharmaceuticals and issued 8,333 shares
(50,000 pre stock split) for the asset purchase from Quest Pharmatech, both
accrued at December 31, 2006 and valued at $165,000 and $19,500.
During the quarter ended June 30, 2007, the Company issued an aggregate of
116,667 shares of common stock in consideration of services to be rendered to
the Company during 2007. Such shares were valued at an aggregate of $157,500
with an average price of $1.35 per share.
C. Private Placement
During the 3rd Quarter of 2007, 889,167 common shares were issued, which
resulted proceeds of $800,250 from private placements received by year-end or in
the first quarter 2007.
D. Common Stock Purchase Agreement
During the quarter ended March 31, 2007, the Company issued 186,666 shares (1.12
million pre stock split) in exchange for $280,000 in connection with Purchase
Agreement II with Fusion Capital.
During the quarter ended June 30, 2007, the Company issued 133,334 shares in
exchange for $200,000 in connection with the common stock purchase agreement
with Fusion Capital.
NOTE 5 - COMMITMENTS AND CONTINGENCIES
A. The Company leases various facilities under operating lease agreements
expiring through September 2008. Rental expense for the six and three months
ended June 30, 2007 was $36,040 and $20,395, respectively. Rental expense for
the six and three months ended June 30, 2006 was $39,090 and $16,957,
respectively. Future minimum annual lease payments under the facilities lease
agreements lasting more than one year are as follows:
2007 $28,286
2008 $43,307
17
B. At the beginning of the third quarter 2007, the Company executed a research
collaboration (the "Research Collaboration") with The Research Institute of
McGill University Health Centre and Samaritan Therapeutics over a ten-year
period through 2017. The budget is for $1,000,000 paid over four (4) quarterly
payments of $250,000, is unallocated, and covers the general research and
development effort. Under the Research Collaboration, the Company receives
worldwide exclusive rights, excluding Canada, to any novel therapeutic agents or
diagnostic technologies that may result from the Research Collaboration.
Samaritan Therapeutics receives exclusive rights to the Canadian market to any
novel therapeutic agents or diagnostic technologies that may result from the
Research Collaboration. The Company also terminated the Georgetown University
research collaboration in the second quarter of 2007; however, Samaritan
Pharmaceuticals' existing worldwide exclusive rights to licensed technologies
with Georgetown will remain in force under the terms of their respective license
agreements.
C. The Company Compensation Committee is in the process of negotiating new
employment agreements with Dr. Janet Greeson and Mr. Eugene Boyle. Dr. Thomas
Lang and Dr. Christos Dakas each have employment agreements negotiated at arm's
length with the Compensation Committee, and each such agreement provides for a
minimum annual base salary. In setting base salaries, the Board has considered
(a) the contributions made by each executive to our Company, (b) compensation
paid by peer companies to their executive officers and (c) outside compensation
reports. In 2006, all executive officers received salary increases of
approximately 5% reflecting competitive trends, general economic conditions as
well as a number of factors relating to the particular individual, including the
performance of the individual executive, level of experience and ability and
knowledge of the job.
The Compensation Committee also has the authority to award discretionary bonuses
to executive officers. The incentive bonuses are intended to compensate officers
for achieving financial and operational goals and for achieving individual
annual performance objectives. These objectives vary depending on the individual
executive, but relate generally to strategic factors such as; 1) initial signing
of an employment agreement; 2) upon acceptance of filing of a new drug
application by the FDA; 3) the FDA approval to move from one phase to the next
phase in the FDA application process; 4) pharmaceutical sales goals achieved; 5)
completion of an in-licensing contract; 6) completion of an out-licensing
contract; and 7) increases in market capitalization. The Compensation Committee
did not make any cash bonuses to the executive officers in 2006.
NOTE 6 - LITIGATION
Samaritan, from time to time, is involved in various legal proceedings in the
ordinary course of its business.
NOTE 7 - RELATED PARTY TRANSACTIONS
In the ordinary course of business, the Company entered into transactions with
Clay County Holdings ("CCH"). These transactions include loans made to and from
CCH. In the past, CCH had made a loan to Samaritan which Samaritan paid off in
2003. During 2004, Samaritan created a note receivable with CCH for $250,000
which amount bears interest at a rate of twelve percent (12%) per annum. A
Director of the Company is related to the Chairman of the Board of CCH but is
not a shareholder of CCH. The CEO and CFO of the Company are mother and son.
NOTE 8 - FUSION TRANSACTION
On May 12, 2005, The Company entered into the Purchase Agreement II with Fusion
Capital, pursuant to which Fusion Capital has agreed to purchase our common
stock from time to time, at our option, up to an aggregate amount of $40,000,000
over fifty (50) months commencing December 29, 2005, which is the date the SEC
declared effective our Registration Statement on Form SB-2 (Commission
Registration No. 051267250). Samaritan filed a post effective amendment on Form
S-1 to the above Registration Statement (Commission Registration No. 07556090)
on January 9, 2007, which was declared effective on February 6, 2007.
18
Under the Purchase Agreement II agreement, The Company has set a minimum
purchase price ("floor price") of $1.50. Fusion Capital shall not have the right
or the obligation to purchase shares of our common stock on any business day
that the market price of our common stock is below $1.50. On August 7, 2007, the
last reported market sale price of our common stock was $1.20. Accordingly, the
Company cannot currently access funds under the Purchase Agreement II and will
not be able to access such funds in the future unless the market price our
common stock exceeds $1.50 per share.
Assuming a minimum purchase price of $1.50 per share and the purchase by Fusion
Capital of the full 368,229 remaining shares under the Purchase Agreement II,
the remaining proceeds to us would be $552,344 unless we choose to register more
than 368,229 shares, which we have the right, but not the obligation, to do. In
the event we elect to sell more than the 368,229 shares, we will be required to
file a new Registration Statement and have it declared effective by the U.S.
Securities & Exchange Commission.
If the Company continues to be unable to access funds under the Purchase
Agreement II, then we may need to sell additional equity securities in private
placements. As of June 30, 2007, with 234,895 remaining available under the
Registration Statement, the selling price of our common stock to Fusion Capital
will have to average at least $151.13 per share for us to receive the remaining
proceeds of $35,499,999 without registering additional shares of common stock.
Shares issued through June 30, 2007 under the Common Stock Purchase Agreement
are 2,265,105, with proceeds of $4,500,001. In second quarter 2007, the Company
received $200,000 in exchange for the issuance of 133,334 shares to Fusion
Capital.
NOTE 9 - RISKS AND UNCERTAINTIES
Marketability of the Company's product is dependent, among other things, upon
securing additional capital to successfully complete the clinical testing,
securing FDA approval, and procurement of viable patents.
NOTE 10 - SUBSEQUENT EVENTS (Unaudited)
On June 28, 2007, Samaritan announced that its Board of Directors has
unanimously decided to reorganize its stock structure by initiating a
one-for-six reverse split of its common stock which shall become effective at
the opening of trading on July 5, 2007, in order to comply with The American
Stock Exchange's Company Guide, Sections 1003(f)(v), regarding listing
requirements for a Company's stock selling at a low price per share for a
substantial period of time.
On July 10, 2007, Samaritan announced that it has confirmed Caprospinol's
(SP-233) efficacy in its ability to dramatically decrease beta amyloid plaque in
the brain, accompanied by a complete recovery of memory back to baseline
(p=0.002), as shown in a Morris water maze task. This study confirms previously
reported in-vitro data and suggests Caprospinol may not only slow down
Alzheimer's but may also reverse plaque-related brain injuries associated with
the mind-robbing disease of Alzheimer's.
On July 24, 2007, Samaritan Pharmaceuticals announced that it has entered into
an exclusive license agreement with Georgetown University for "Benzamide
Compounds" patent rights to treat HIV and numerous other infectious diseases.
The underlying licensed patent application describes using Benzamide compounds
as an innovative new method to treat the HIV virus and other infectious
diseases, such as Avian Influenza A, Influenza A & B, and Hepatitis B & C. Under
the terms of the agreement, Samaritan will have exclusive worldwide rights to
develop, manufacture and commercialize Benzamide compounds in exchange for
royalties.
On July 30, 2007, the Company announced that it has entered into an exclusive
licensing agreement with Georgetown University for an innovative blood test
diagnostic that detects whether a breast tumor is cancer and if diagnosed as
cancer, the blood test detects the cancer's aggressiveness to metastasize and
spread throughout the body. The innovative cancer diagnostic blood test was
discovered as a result of its research and development collaboration with
Georgetown University giving Samaritan first rights to license. The diagnostic
screens for targeted tumor cell markers and has demonstrated the ability to
identify just one circulating breast cancer cell out of millions of normal blood
cells.
19
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
General
Samaritan Pharmaceuticals, Inc. (including the subsidiaries, referred to as
"Samaritan", the "Company", "it", "we", and "our"), formed in September 1994, is
an entrepreneurial biopharmaceutical pipeline company, focused on
commercializing innovative therapeutic products to relieve the suffering of
patients with Alzheimer's disease; cancer; cardiovascular disease, HIV, and
Hepatitis C; as well as, commercializing its acquired marketing and sales rights
to sell ten (10) marketed products in Greece and/or various Eastern European
countries.
Samaritan is focused on commercializing three blockbuster market drug candidates
with late-stage preclinical (non-clinical) development programs. Samaritan is
evaluating the use of Caprospinol, SP-233 in Alzheimer's disease patients; the
use of SP-1000 with acute coronary disease patients; and the use of SP-10 as an
"oral treatment" for Hepatitis C patients. In addition, Samaritan has partnered
its oral entry inhibitor HIV drug SP-01A with Pharmaplaz, Ireland.
Commercialization Business Model
Our commercialization business model is focused dually on, the partnering of our
promising innovative products to pharmaceutical companies; and the acquisition
of the marketing and sales rights to revenue-generating marketed products for
sales in Greece and Eastern Europe. This model allows Samaritan to focus on our
core competencies in drug discovery and drug development. Samaritan partners
promising innovative therapeutics anywhere in the early "human" clinical trial
stage, i.e. late-stage preclinical studies, Phase I Clinical trials, or proof of
concept, Phase II clinical trials, with the objective of partnering before
costly Phase III clinical trials. Potential revenue streams with this model
could include up-front fees, milestone payments, and participation in the
marketing success of partnered products through royalties. In addition,
Samaritan is enhancing and strengthening our sales and marketing force in Greece
and Eastern Europe to allow for the significant economics gained by advancing
the commercialization of our contracted marketed products. Our business model is
entirely focused on achieving growth and maximizing value for the benefit of our
shareholders.
Licensing and Collaborative Agreements
To build, advance and promote our product portfolio, Samaritan often seeks to
augment our own internal programs and capabilities with collaborative projects
with a number of outside partners. For our marketed products, we have
established certain license agreements, co-promotion arrangements,
manufacturing, supply and co-development alliances with pharmaceutical and other
biotechnology companies, academic institutions and government laboratories to
which we currently pay royalties. Similarly, for product candidates now in
development, we have secured licenses to certain intellectual property and
entered into strategic alliances with third parties for various aspects of
research, development, manufacturing and commercialization, pursuant to which we
will owe or receive future royalties if the product candidates are licensed and
commercialized.
The Company has a research collaboration (the "Research Collaboration") with The
Research Institute of McGill University Health Centre and Samaritan Therapeutics
over a ten-year period through 2017. The budget is for $1,000,000 paid over four
(4) quarterly payments of $250,000, is unallocated, and covers the general
research and development effort. Under the Research Collaboration, the Company
receives worldwide exclusive rights, excluding Canada, to any novel therapeutic
agents or diagnostic technologies that may result from the Research
Collaboration. Samaritan Therapeutics receives exclusive rights to the Canadian
market to any novel therapeutic agents or diagnostic technologies that may
result from the Research Collaboration. The Company also terminated the
Georgetown University research collaboration in the second quarter of 2007;
however, Samaritan Pharmaceuticals' existing worldwide exclusive rights to
licensed technologies with Georgetown will remain in force under the terms of
their respective license agreements.
20
On March 28, 2007, Samaritan and Pharmaplaz, LTD ("Pharmaplaz"), a shareholder,
announced they have an agreement to commercialize SP-01A, an "oral" HIV entry
inhibitor. Under the terms of the agreement, Pharmaplaz, a shareholder, is
required to pay Samaritan $10 million in upfront fees. The first payment of $1.4
million was received on March 28, 2007, and the remaining $8.6 million is
required to be paid on September 16, 2007. Pharmaplaz, a shareholder, will pay
for and be responsible for future research and development to bring the
technology to market. Samaritan has no remaining obligations or performance for
future research and development. The $10,000,000 payment is non-refundable. Upon
request, Samaritan might occasionally advise Pharmaplaz regarding SP-01A, in
relationship to Principal Investigators with applications for NIH grants, or
other grant applications to advance SP-01A, at Pharmaplaz's cost. Samaritan and
Pharmaplaz will split 50/50 of all revenues stemming from SP-01A.
Marketed Products
Samaritan has also entered into strategic collaborative relationships with other
pharmaceutical companies to commercialize branded approved prescription products
in Samaritan's selected niche territories, such as, in Greece, Albania, Bosnia,
Bulgaria, Croatia, Cyprus, Czech Republic, Egypt, FYROM, Hungary, Montenegro,
Poland, Romania, Serbia, Slovakia, Slovenia, Syria and Turkey. We use our
expertise to register approved drugs with regulatory agencies in the country we
have acquired the rights for; and then, upon regulatory approval, we distribute,
market and sell these products. Currently, we have in-licensed the rights to
sell ten (10) drugs, Amphocil from Three Rivers Pharmaceuticals, Elaprase and
Replagal from Shire Pharmaceuticals, Infasurf from Ony, Inc, and Mepivamol,
Methadone, Morphine Sulphate, Naloxone, Naltrexone, and Oramorph from Molteni
Farmaceutici. Our efforts are focused on specialist physicians in private
practice or at hospitals and major medical centers in our territories. Below is
a description of our in-licensed products.
AMPHOCIL(R)
AMPHOCIL(R) is a lipid form of amphotericin B indicated for the treatment of
invasive aspergillosis, a life threatening systemic fungal infection.
AMPHOCIL(R) is indicated for the treatment of severe systemic and/or deep
mycoses in cases where toxicity or renal failure precludes the use of
conventional amphotericin B in effective doses, and in cases where prior
systemic antifungal therapy has failed. Fungal infections successfully treated
with AMPHOCIL(R) include disseminated candidiasis and aspergillosis. AMPHOCIL(R)
has been used successfully in severely neutropenic patients.
AMPHOCIL(R) is an approved FDA prescription product owned by Three Rivers
Pharmaceuticals, Inc. and marketed by Three Rivers Pharmaceuticals, Inc. in the
US. Samaritan signed an exclusive distribution deal for Greece and Cyprus with
Three Rivers on December 14, 2005.
Currently, Samaritan is marketing Amphocil(R) in Greece. Marketing authorization
for Amphocil (R) is pending in Cyprus.
ELAPRASE(R)
ELAPRASE(R) is a human enzyme replacement therapy for the treatment of Hunter
syndrome, also known as Mucopolysaccharidosis II (MPS II). Hunter syndrome is a
rare, life-threatening genetic condition that results from the absence or
insufficient levels of the lysosomal enzyme iduronate-2-sulfatase. Without this
enzyme, cellular waste products accumulate in tissues and organs, which then
begin to malfunction.
ELAPRASE(R) was granted marketing authorization for the long-term treatment of
patients with Hunter's disease by the European Commission in January 2007.
ELAPRASE(R) is the first, and only, enzyme replacement therapy for Hunter's
disease patients and was launched in the U.S. in July 2006.
ELAPRASE(R) will be sold and distributed by Samaritan on a named patient basis
until the pricing and the reimbursement of ELAPRASE(R) is established in Greece
and Cyprus, with the relevant regulatory authorities. Samaritan signed an
exclusive licensing agreement with Shire Pharmaceuticals for the marketing and
sale of ELAPRASE(R) in Greece and Cyprus, which became effective March 1, 2007.
21
INFASURF(R)
INFASURF(R) treats and prevents Respiratory Distress Syndrome (RDS). This
syndrome occurs when infants lack surfactant, a natural substance normally
produced in the body, which is necessary for lungs to function normally.
INFASURF(R) is used exclusively in hospitals with a neonatal intensive care unit
(NICU) and is administered by neonatologists, neonatal nurses, neonatal nurse
practitioners and respiratory therapists.
On January 16, 2007, Samaritan signed an exclusive agreement with Siraeo, Ltd
for the marketing and distribution of the product INFASURF(R) in Turkey, Serbia,
Bosnia, Macedonia, Albania, Egypt and Syria. INFASURF(R) is an approved FDA
prescription product owned by ONY, Inc. and marketed by Forest Laboratories in
the US.
Currently, Samaritan Pharmaceuticals is utilizing the US FDA approved regulatory
file in preparing marketing applications for INFASURF(R) with regulatory
authorities in Turkey, Serbia, Bosnia, F.Y.R.O.M., Albania, Egypt and Syria to
gain country marketing authorization drug approval.
MEPIVAMOL(R)
MEPIVAMOL(R) (Mepivacaine) is an effective and reliable local anesthetic of
intermediate duration and low systemic toxicity. It is widely used for regional
anesthetic procedures such as IVRA, infiltration, epidural blockade, plexus and
peripheral nerve blockade. MEPIVAMOL(R) is approved by the Italian Ministry of
Health (The equivalent to the US FDA) and is owned by Molteni Farmaceutici, Inc.
and marketed by Molteni Farmaceutici, Inc. in Italy.
On January 1, 2007, Samaritan entered into an exclusive licensing agreement with
Molteni Farmaceutici for the marketing and distribution of MEPIVAMOL(R) in the
countries of Greece and Cyprus. Currently, Samaritan Pharmaceuticals is
utilizing the Italian Ministry of Health approved regulatory file in preparing
marketing applications for MEPIVAMOL(R) with regulatory authorities in Greece
and Cyprus to gain country marketing authorization drug approval.
METHADONE HCL(R)
METHADONE HCL(R) is an opiate agonist. METHADONE HCL(R) prevents heroin or
morphine from interacting with receptors for natural painkillers called
endorphins, blocking the effects of the addictive drugs and reducing the
physical cravings. METHADONE HCL(R) is approved by the Italian Ministry of
Health (The equivalent to the US FDA) and is owned by Molteni Pharmaceuticals,
Inc. and marketed by Molteni Farmaceutici, Inc. in Italy.
On January 1, 2007, Samaritan entered into an exclusive licensing agreement with
Molteni Farmaceutici for the marketing and distribution of METHADONE HCL(R) in
the countries of Greece and Cyprus.
Currently, METHADONE HCL(R) can only be sold in Greece and Cyprus via a
centralized government tender. Samaritan is preparing a tender application for
the next request by Greek authorities for applications.
MORPHINE SULPHATE(R)
MORPHINE SULPHATE(R) (Injectable Formulation) relieves moderate to severe pain
by binding to brain receptors. Morphine Sulphate may be used to control the pain
following surgery, child birth, and other procedures. It may also be used to
treat the pain associated with cancer, heart attacks, sickle cell disease and
other medical conditions.
22
On January 1, 2007, Samaritan entered into an exclusive licensing agreement with
Molteni Farmaceutici for the marketing and distribution of MORPHINE SULPHATE(R)
in the countries of Greece and Cyprus.
Currently, MORPHINE SULPHATE(R) can only be sold in Greece and Cyprus via a
centralized government tender. Samaritan is preparing a tender application for
the next request by Greek authorities for applications.
NALOXONE MOLTENI(R)
NALOXONE MOLTENI(R) is an opioid antagonist which reverses the effects of opioid
overdose, for example heroin and morphine overdose. Specifically, Naloxone is
used in opioid overdoses for countering life-threatening depression of the
central nervous system and respiratory system.
On January 1, 2007, Samaritan entered into an exclusive licensing agreement with
Molteni Farmaceutici for the marketing and distribution of NALOXONE MOLTENI(R)
in the countries of Greece and Cyprus.
Currently, NALOXONE(R) will be sold and distributed by Samaritan on a named
patient basis until the pricing and the reimbursement of NALOXONE(R) is
established in Greece and Cyprus, with the relevant regulatory authorities.
NALTREXONE MOLTENI(R)
NALTREXONE MOLTENI(R) is an opioid antagonist which is used to help people who
have a narcotic or alcohol addiction stay drug free. NALTREXONE MOLTENI(R) is
used after the patient has stopped taking drugs or alcohol. It works by blocking
the effects of narcotics or by decreasing the craving for alcohol.
NALTREXONE MOLTENI(R) is approved by the Italian Ministry of Health (The
equivalent to the US FDA) and is owned by Molteni Farmaceutici, Inc. and
marketed by Molteni Farmaceutici, Inc. in Italy.
On January 1, 2007, Samaritan entered into an exclusive licensing agreement with
Molteni Farmaceutici for the marketing and distribution of NALTREXONE MOLTENI(R)
in the countries of Greece and Cyprus.
Currently, Samaritan Pharmaceuticals is utilizing the Italian Ministry of Health
approved regulatory file in preparing marketing applications for NALTREXONE
MOLTENI(R) with regulatory authorities in Greece and Cyprus to gain country
marketing authorization drug approval.
ORAMORPH(R)
ORAMORPH(R) is morphine sulphate in an oral solution and is used for managing
moderate to severe chronic pain for more than a few days. It works by dulling
the pain perception center in the brain. ORAMORPH(R) is approved by the Italian
Ministry of Health (The equivalent to the US FDA) and is marketed by Molteni in
Italy.
ORAMORPH(R) is approved by the Italian Ministry of Health (The equivalent to the
US FDA) and is owned by Molteni Farmaceutici, Inc. and marketed by Molteni
Farmaceutici, Inc. in Italy.
On January 1, 2007, Samaritan entered into an exclusive licensing agreement with
Molteni Farmaceutici for the marketing and distribution of ORAMORPH(R) in the
countries of Greece and Cyprus.
Currently, Oramorph has a Greek marketing authorization. Oramorph can only be
sold in Greece via a centralized government tender. Samaritan is preparing a
tender application for the next request by Greek authorities for applications.
23
REPLAGAL(R)
REPLAGAL(R) is a long-term enzyme replacement therapy used to treat patients
with a confirmed diagnosis of Fabry Disease. Fabry Disease is caused by a
deficiency of an enzyme, alpha-galactosidase A (also called
ceramidetrihexosidase), involved in the breakdown of fats.
Samaritan signed an exclusive licensing agreement with Shire Pharmaceuticals for
the marketing and sale of Replagal(R) in Greece and Cyprus, which became
effective May 1, 2007. Currently, REPLAGAL(R) has a Greek and Cyprus pricing,
reimbursement and marketing authorization.
Plan and Results of Operations
We have used the proceeds from private placements of our capital stock,
primarily to expand our preclinical and clinical efforts, as well as for general
working capital. At this time, we are beginning to commit additional resources
to the development of SP-233, as well as for the development of our other drugs.
Additional details regarding the human trials and INDs the Company plans to file
may be found in the section entitled "Description of Business" in the Company's
Annual Report on Form 10-K/A filed with the SEC on April 27, 2007 for the fiscal
year ended December 31, 2007.
On July 5, 2007, the Company's Board of Directors effected a one-for-six reverse
stock split of its common stock. The financial statements presented herein have
been restated to reflect the reverse stock split as if it had occurred at the
beginning of each period presented. All share and per share information included
in these consolidated financial statements has been adjusted to reflect this
reverse stock split.
Results of Operations For The Three (3) Months Ended June 30, 2007 As Compared
To The Three (3) Months Ended June 30, 2006
Revenue for the three-month period ended June 30, 2007, as compared to June 30,
2006, pharmaceuticals sales increased to $408,811 from $0, respectively. This
increase of $408,811 was primarily related to the launch of the products
Amphocil and Elaprase in June 2007 in Greece. We expect product sales of
Amphocil and Elaprase to increase in future periods primarily to additional
patients initiating therapy.
We incurred research and development expenses of $554,113 for the three months
ended June 30, 2007, as compared to $1,510,490 for the three months ended June
30, 2006. This decrease of $956,377 or sixty-three percent (63%) was primarily
attributable to the culmination of the costs associated with our HIV clinical
trial. We expect research and development expenditures relating to drug
discovery and development will increase during the remainder of 2007 and into
subsequent years due to the expanding requirements of FDA clinical trials for:
(a) our Alzheimer's drug program; (b) the initiation of trials for other
potential indications; and (c) additional study expenditures for potential
pharmaceutical candidates. Research and development expenses may fluctuate from
period to period, depending upon the stage of certain projects and the level of
preclinical testing and clinical trial-related activities.
General and administrative expenses increased to $759,978 for the three months
ended June 30, 2007, as compared to $719,591 for the three months ended June 30,
2006. This increase of $40,387 or six percent (6%), was primarily attributable
to an increase in cost of payroll as offset by decreases in amortization of
deferred compensation and consulting.
Depreciation and amortization amounted to $46,453 for the three months ended
June 30, 2007, as compared to $35,035 for the three months ended June 30, 2006.
This increase of $11,418, or thirty-three percent (33%), was primarily
attributable to increases in amortization on both purchased technology and
approved patents.
Net interest income amounted to $7,595 and $7,561 for the three (3) months ended
June 30, 2007 and 2006, respectively. The credit balance in the interest expense
account is attributable to offsetting interest earned from holding our cash in
marketable securities and certificates of deposits. Interest income was $(7,595)
and $(7,561), for the three (3) months ended June 30, 2007 and 2006,
respectively. Interest expense was $-0- and $-0-, for the three (3) months ended
June 30, 2007 and 2006, respectively.
24
We had a loss of $1,231,973 for the three months ended June 30, 2007, as
compared to a loss of $2,257,555 for the three months ended June 30, 2006. The
decreased loss was primarily due to the launch of Amphocil and Elaprase and the
decrease attributable to the culmination of the costs associated with our HIV
clinical trials. As disclosed in the financial statements, earnings (loss) per
share was ($.05) and ($.09) per share (undiluted), for the three months ended
June 30, 2007 and 2006, respectively.
Results of Operations For The six (6) Months Ended June 30, 2007 As Compared To
The six (6) Months Ended June 30, 2006
Revenue for the six-month period ended June 30, 2007, as compared to June 30,
2006, pharmaceuticals sales increased to $408,811 from $0, respectively. This
increase of $408,811 was primarily related to the launch of the products
Amphocil and Elaprase in June 2007 in Greece. We expect product sales of
Amphocil and Elaprase to increase in future periods primarily to additional
patients initiating therapy.
On March 28, 2007, Samaritan and Pharmaplaz, a shareholder, announced they have
entered into an agreement to commercialize SP-01A, an "oral" HIV entry
inhibitor. Under the terms of the agreement, Pharmaplaz, a shareholder, is
required to pay Samaritan $10 million in upfront fees. The first payment of $1.4
million was received on March 28, 2007, and the remaining $8.6 million is
required to be paid on September 16, 2007. Pharmaplaz, a shareholder, will pay
for and be responsible for future research and development to bring the
technology to market. Samaritan has no remaining obligation or performance for
future research and development. The $10,000,000 payment is non-refundable. Upon
request, Samaritan might occasionally advise Pharmaplaz regarding SP-01A, in
relationship to Principal Investigators with applications for NIH grants, or
other grant applications to advance SP-01A, at Pharmaplaz's cost. Samaritan and
Pharmaplaz will split 50/50 of all revenues stemming from SP-01A.
In the first quarter of 2007, Samaritan recognized as revenue $2,701,742 from
the Pharmaplaz Agreement, which is comprised of the $1,400,000 cash received and
$1,301,742 in receivable that Samaritan determined collectibility to be
reasonably assured. There was insufficient time prior to filing of this report
to perform necessary procedures to assure the collectibility of the remaining
balance due from Pharmaplaz on September 16, 2007. The remaining $7,298,258 will
be recognized as collectibility is assured or when the actual funds are
received.
We incurred research and development expenses of $971,636 for the six months
ended June 30, 2007, as compared to $2,099,709 for the six months ended June 30,
2006. This decrease of $1,128,073, or fifty-four percent (54%), was primarily
attributable to the culmination of the costs associated with our HIV clinical
trial. We expect research and development expenditures relating to drug
discovery and development will increase during the remainder of 2007 and into
subsequent years due to the expanding requirements of FDA clinical trials for:
(a) our Alzheimer's drug program; (b) the initiation of trials for other
potential indications; and (c) additional study expenditures for potential
pharmaceutical candidates. Research and development expenses may fluctuate from
period to period, depending upon the stage of certain projects and the level of
preclinical testing and clinical trial-related activities.
General and administrative expenses increased to $1,427,389 for the six months
ended June 30, 2007, as compared to $1,316,743 for the six months ended June 30,
2006. This increase of $110,646 or eight percent (8%), was primarily
attributable to an increase in cost of payroll as offset by decreases in
amortization of deferred compensation and consulting.
Depreciation and amortization amounted to $90,089 for the six months ended June
30, 2007, as compared to $69,822 for the six months ended June 30, 2006. This
increase of $20,267, or twenty-nine percent (29%), was primarily attributable to
increases in amortization on both purchased technology and approved patents.
Net interest income amounted to $15,049 and $16,527 for the six (6) months ended
June 30, 2007 and 2006, respectively. The credit balance in the interest expense
account is attributable to offsetting interest earned from holding our cash in
marketable securities and certificates of deposits. Interest income was $15,049
and $16,534 , for the six (6) months ended June 30, 2007 and 2006, respectively.
Interest expense was $-0- and $6.59, for the six (6) months ended June 30, 2007
and 2006, respectively.
25
We had earnings of $348,653 for the six months ended June 30, 2007, as compared
to a loss of $3,451,114 for the six months ended June 30, 2006. Earnings were
the result of the sale of rights to Pharmaplaz, as described in the notes. As
disclosed in the financial statements, earnings (loss) per share was $.01 and
($.15) per share (undiluted), for the six months ended June 30, 2007 and 2006,
respectively.
The net loss since our inception on September 5, 1994 through June 30, 2007 was
$40,960,489. We expect losses to continue for the near future, and such losses
will likely increase as human clinical trials are undertaken in the United
States. Future profitability will be dependent upon our ability to complete the
development of our pharmaceutical products, obtain necessary regulatory
approvals and effectively market such products. In addition, future
profitability will require the Company to establish agreements with other
parties for clinical testing, manufacturing, commercialization and sale of its
products.
Liquidity and Capital Resources
As of June 30, 2007, the Company's cash position was $393,659. We are continuing
efforts to raise additional capital and to execute our research and development
plans. Even if we are successful in raising sufficient money to carry out these
plans, additional clinical development is necessary to bring our products to
market, which will require a significant amount of additional capital.
Cash used in operating activities during the six (6) month period ended June 30,
2007 was $(1,134,669), as compared to $(3,247,843) for the six month period
ended June 30, 2006, a decrease of $2,113,174. This decrease is primarily
attributable to fluctuations and timing of the cost with our HIV clinical trial,
and the receipt of the $1.4 million from Pharmaplaz, the first payment on the
sale of licensing rights.
Cash provided (used) by investing activities was ($262,495) for the six (6)
month period ended June 30, 2007, as compared to cash provided of $452,140 for
the six (6) month period ended June 30, 2006, a decrease of $714,635. Last year,
the period reflected proceeds from the liquidation of a certificate of deposit
for use in funding 2006 activities. The current year's period includes increases
in patent costs.
Cash provided by financing activities was $1,048,748 for the six (6) month
period ended June 30, 2007, as compared to $4,018,014 for the six (6) month
period ended June 30, 2006, an decrease of $2,969,266 or seventy-four percent
(74%). Last year's results include proceeds of $1,645,000 from private
placements, and $2,308,514 from the Purchase Agreement II with Fusion. Because
of the decrease in immediate research costs and the sale of licenses rights to
Pharmaplaz, the Company did not raise as much capital. Therefore, private
placement proceeds (classified as common stock to be issued) and draws from
Fusion were $568,748 and $480,000, respectively.
Current assets as of June 30, 2007 were $2,998,146 as compared to $1,073,921 as
of December 31, 2006. This increase of $1,924,225 was primarily attributable to
the receipt of proceeds and recording of an account receivable from the sale of
licensing rights to Pharmaplaz. Current liabilities as of June 30, 2007 were
$1,435,854 as compared to $1,519,565 as of December 31, 2006, a decrease of
$83,711, primarily due to retiring accounts payable through the issuance of
common stock.
On May 12, 2005, we entered into the Purchase Agreement II with Fusion Capital,
pursuant to which Fusion Capital has agreed to purchase our common stock from
time to time, at our option, up to an aggregate amount of $40,000,000 over fifty
(50) months commencing December 29, 2005, which is the date the SEC declared
effective our Registration Statement on Form SB-2 (Commission Registration No.
051267250). Samaritan filed a post effective amendment on Form S-1 to the above
Registration Statement (Commission Registration No. 07556090) on January 9,
2007, which was declared effective on February 6, 2007.
26
Under the Purchase Agreement II agreement, we have set a minimum purchase price
("floor price") of $1.50. Fusion Capital shall not have the right or the
obligation to purchase shares of our common stock on any business day that the
market price of our common stock is below $1.50. On August 7, 2007, the last
reported market sale price of our common stock was $1.20. Accordingly, the
Company cannot currently access funds under the Purchase Agreement II and will
not be able to access such funds in the future unless the market price our
common stock exceeds $1.50 per share.
Assuming a minimum purchase price of $1.50 per share and the purchase by Fusion
Capital of the full 368,229 remaining shares under the Purchase Agreement II,
the remaining proceeds to us would be $552,344 unless we choose to register more
than 368,229 shares, which we have the right, but not the obligation, to do. In
the event we elect to sell more than the 368,229 shares, we will be required to
file a new Registration Statement and have it declared effective by the U.S.
Securities & Exchange Commission.
If we continue to be unable to access funds under the Purchase Agreement II, we
may need to sell additional equity securities in private placements. As of June
30, 2007, with 234,895 remaining available under the Registration Statement, the
selling price of our common stock to Fusion Capital will have to average at
least $151.13 per share for us to receive the remaining proceeds of $35,499,999
without registering additional shares of common stock. Shares issued through
June 30, 2007 under the Common Stock Purchase Agreement are 2,265,105, with
proceeds of $4,500,001. In second quarter 2007, the Company received $200,000 in
exchange for the issuance of 133,334 shares to Fusion Capital.
We believe that existing balances of cash, cash equivalents, marketable
securities, cash generated from operations (out-licensing of SP-01A to
Pharmaplaz and future cash derived from marketed products), and funds
potentially available to us under Purchase Agreement II are sufficient to
finance our current operations and working capital requirements on both a
short-term and long-term basis. However, we cannot predict the amount or timing
of our need for additional funds under various circumstances, which could
include a significant acquisition of a business or assets, new product
development projects, expansion opportunities, or other factors that may require
us to raise additional funds in the future. We cannot provide assurance that
funds will be available to Samaritan when needed on favorable terms, or at all.
On March 28, 2007, Samaritan and Pharmaplaz announced they have an agreement to
commercialize SP-01A, an "oral" HIV entry inhibitor. Under the terms of the
agreement, Pharmaplaz, a shareholder, is required to pay Samaritan $10 million
in upfront fees. The first payment of $1.4 million was received on March 28,
2007, and the remaining $8.6 million is required to be paid on September 16,
2007. Pharmaplaz, a shareholder, will pay for and be responsible for future
research and development to bring the technology to market. Samaritan has no
remaining obligations or performance for future research and development. The
$10,000,000 payment is non-refundable. Upon request, Samaritan might
occasionally advise Pharmaplaz regarding SP-01A, in relationship to Principal
Investigators with applications for NIH grants, or other grant applications to
advance SP-01A, at Pharmaplaz's cost. Samaritan and Pharmaplaz will split 50/50
of all revenues stemming from SP-01A.
We will continue to have significant general and administrative expenses,
including expenses related to clinical studies, our research collaboration with
universities and patent registration costs. Except for the Purchase Agreement II
with Fusion Capital, no commitment exists for continued investments, or for any
underwriting.
In addition to our financing arrangements with Fusion Capital (as discussed
above), we may require substantial additional funds to sustain our operations
and to grow our business. The amount will depend, among other things, on (a) the
rate of progress and cost of our research and product development programs and
clinical trial activities; (b) the cost of preparing, filing, prosecuting,
maintaining and enforcing patent claims and other intellectual property rights;
and (c) the cost of developing manufacturing and marketing capabilities, if we
decide to undertake those activities. The clinical development of a therapeutic
product is a very expensive and lengthy process which may be expected to utilize
$5 to $20 million over a three (3) to six (6) year development cycle. We may
also need to obtain additional funds to develop our therapeutic products and our
future access to capital is uncertain. The allocation of limited resources is an
ongoing issue for us as we move from research activities into the more costly
clinical investigations required to bring therapeutic products to market. We
also expect to generate revenues from our marketed products in the near future,
and our business model has changed from a development model to a licensing and
development model. For more information on the change in business model, please
see "Business Model" section.
27
The extent to which we rely on Fusion Capital as a source of funding will depend
on a number of factors, including the prevailing market price of our common
stock (which must exceed $1.50 per share) and the extent to which we are able to
secure working capital from other sources. Even if we are able to access the
full amounts under Purchase Agreement II with Fusion Capital, we may still need
additional capital to fully implement our business, operating and development
plans. If we are unable to obtain additional financing, we might be required to
delay, scale back or eliminate selected research and product development
programs or clinical trials, or be required to license third parties to
commercialize products or technologies that we would otherwise undertake
ourselves, or cease certain operations all together. However, any of these
options might have a material adverse effect upon the Company. If we raise
additional funds by issuing equity securities, dilution to stockholders may
result, and new investors could have rights superior to existing holders of
shares. Should the financing we require to sustain our working capital needs be
unavailable or prohibitively expensive when we require it, the consequences
would have a material adverse effect on our business, operating results,
financial condition and prospects.
We have been able to meet our cash needs during the past twelve (12) months
through a combination of funds received through private placements and funds
received under the purchase agreements with Fusion Capital. Currently, we have
out-licensed our SP-01A and in-licensed the rights to sell ten (10) drugs,
Amphocil from Three Rivers Pharmaceuticals, Elaprase and Replagal from Shire
Pharmaceuticals, Infasurf from Ony, Inc, and Mepivamol, Methadone, Morphine
Sulphate, Naloxone, Naltrexone, and Oramorph from Molteni Pharmaceuticals to
meet our cash needs. We intend to continue to explore avenues to obtain
additional capital through private placements and by the sale of our shares of
common stock to Fusion Capital.
Forward-Looking Information and Factors that May Affect Future Results
The Securities and Exchange Commission encourages companies to disclose
forward-looking information so that investors can better understand a company's
future prospects and make informed investment decisions. This report and other
written or oral statements that we make from time to time contain such
forward-looking statements that set forth anticipated results based on
management's plans and assumptions. Such forward-looking statements involve
substantial risks and uncertainties. We have tried, wherever possible, to
identify such statements by using words such as "will," "anticipate,"
"estimate," "expect," "project," "intend," "plan," "believe," "target,"
"forecast" and other words and terms of similar meaning in connection with any
discussion of future operating or financial performance or business plans and
prospects. In particular, these include statements relating to future actions,
business plans and prospects, prospective products or product approvals, future
performance or results of current and anticipated products, sales efforts,
expenses, interest rates, foreign exchange rates, the outcome of contingencies,
such as legal proceedings, and financial results. Among the factors that could
cause actual results to differ materially are the following:
o the success of research and development activities;
o decisions by regulatory authorities regarding whether and when to approve our
drug applications, as well as their decisions regarding labeling and other
matters that could affect the availability or commercial potential of our
products;
o the speed with which regulatory authorizations, pricing approvals and product
launches may be achieved;
o the success of external business development activities;
o competitive developments, including with respect to competitor drugs and drug
candidates that treat diseases and conditions similar to those treated by our
in-line drugs and drug candidates;
o the ability to successfully market both new and existing products domestically
and internationally;
o difficulties or delays in manufacturing;
o trade buying patterns;
28
o the ability to meet generic and branded competition after the loss of patent
protection for our products and competitor products;
o the impact of existing and future regulatory provisions on product
exclusivity;
o trends toward managed care and healthcare cost containment;
o Legislation or regulatory action in our marketed territories affecting,
among other things, pharmaceutical product pricing, reimbursement or access,
the importation of prescription drugs and the involuntary approval of
prescription medicines for over-the-counter use;
o claims and concerns that may arise regarding the safety or efficacy of or
marketed products and product candidates;
o legal defense costs, insurance expenses, settlement costs and the risk of an
adverse decision or settlement related to product liability, patent
protection, governmental investigations, ongoing efforts to explore various
means for resolving asbestos litigation and other legal proceedings;
o the Company's ability to protect its patents and other intellectual property
both domestically and internationally;
o interest rate and foreign currency exchange rate fluctuations;
o governmental laws and regulations affecting domestic and foreign operations,
including tax obligations;
o changes in U.S. generally accepted accounting principles;
o any changes in business, political and economic conditions due to the threat
of terrorist activity in the U.S. and other parts of the world, and related
U.S. military action overseas;
o growth in costs and expenses;
o changes in our product, segment and geographic mix; and
We cannot guarantee that any forward-looking statement will be realized,
although we believe we have been prudent in our plans and assumptions.
Achievement of anticipated results is subject to substantial risks,
uncertainties and inaccurate assumptions. Should known or unknown risks or
uncertainties materialize, or should underlying assumptions prove inaccurate,
actual results could vary materially from past results and those anticipated,
estimated or projected. Investors should bear this in mind as they consider
forward-looking statements.
We undertake no obligation to publicly update forward-looking statements,
whether as a result of new information, future events or otherwise. You are
advised, however, to consult any further disclosures we make on related subjects
in our Forms 10-Q, 8-K and 10-K reports to the Securities and Exchange
Commission. Our Form 10-K/A filing for the 2006 fiscal year filed on April 27,
2007 listed various important factors that could cause actual results to differ
materially from expected and historic results. We note these factors for
investors as permitted by the Private Securities Litigation Reform Act of 1995.
Readers can find them in Part II, Item 1A, of this filing under the heading
"Risk Factors". You should understand that it is not possible to predict or
identify all such factors. Consequently, you should not consider any such list
to be a complete set of all potential risks or uncertainties.
This report includes discussion of certain clinical studies relating to various
in-line products and/or product candidates. These studies typically are part of
a larger body of clinical data relating to such products or product candidates,
and the discussion herein should be considered in the context of the larger body
of data.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
We do not engage in trading market-risk sensitive instruments and do not
purchase hedging instruments or other than trading instruments that are likely
to expose us to market risk, whether interest rate, foreign currency exchange,
commodity price or equity price risk. We have no outstanding debt instruments,
have not entered into any forward or future contracts, and have purchased no
options and entered into no swaps. We have no credit lines or other borrowing
facilities, and do not view ourselves as subject to interest rate fluctuation
risk at the present time.
29
Exchange Risk
We are a multinational business operating in a number of countries with the U.S.
dollar as the primary currency in which we conduct business. The U.S. dollar is
used for planning and budgetary purposes and as the presentation currency for
financial reporting. We do, however, have costs, assets and liabilities
denominated in currencies other than U.S. dollars. Consequently, we may enter
into derivative financial instruments to manage our non-U.S. dollar foreign
exchange risk. We may use derivative financial instruments primarily to reduce
exposures to market fluctuations in foreign exchange rates. We do not enter into
derivative financial instruments for trading or speculative purposes. All
derivative contracts entered into will be in liquid markets with credit-approved
parties.
The U.S. dollar is the base currency against which all identified transactional
foreign exchange exposures are managed and hedged. The principal risks to which
we are exposed are movements in the exchange rates of the U.S. dollar against
the Euro. The main exposures are net costs in Euro arising from a manufacturing
and research presence in Ireland, the sourcing of raw materials in European
markets and marketing and sales in South Eastern Europe.
Recently Issued Accounting Standards
In March 2006, the FASB issued SFAS No. 156, "Accounting for Servicing of
Financial Assets, an amendment of FASB Statement No. 140, Accounting for
Transfers and Servicing of Financial Assets and Extinguishments of Liabilities".
This statement requires all separately recognized servicing assets and servicing
liabilities be initially measured at fair value, if practicable, and permits for
subsequent measurement using either fair value measurement with changes in fair
value reflected in earnings or the amortization and impairment requirements of
Statement No. 140. The subsequent measurement of separately recognized servicing
assets and servicing liabilities at fair value eliminates the necessity for
entities that manage the risks inherent in servicing assets and servicing
liabilities with derivatives to qualify for hedge accounting treatment and
eliminates the characterization of declines in fair value as impairments or
direct write-downs. SFAS No. 156 is effective for an entity's first fiscal year
beginning after September 15, 2006. The adoption of this statement did not have
a material impact on the Company's financial position or results of operations.
In July 2006, the Financial Accounting Standards Board "FASB" issued FASB
Interpretation (FIN) No. 48, "Accounting for Uncertainty in Income Taxes-an
interpretation of FASB Statement No. 109." This interpretation provides guidance
for recognizing and measuring uncertain tax positions, as defined in SFAS No.
109, "Accounting for Income Taxes." FIN No. 48 prescribes a threshold condition
that a tax position must meet for any of the benefit of an uncertain tax
position to be recognized in the financial statements. Guidance is also provided
regarding de-recognition, classification, and disclosure of uncertain tax
positions. FIN No. 48 is effective for fiscal years beginning after December 15,
2006. The Company does not expect that this interpretation will have a material
impact on its financial position, results of operations, or cash flows.
In September 2006, the FASB issued FASB Statement No. 157. This Statement
defines fair value, establishes a framework for measuring fair value in
generally accepted accounting principles (GAAP), and expands disclosures about
fair value measurements. This Statement applies under other accounting
pronouncements that require or permit fair value measurements, the Board having
previously concluded in those accounting pronouncements that fair value is a
relevant measurement attribute. Accordingly, this Statement does not require any
new fair value measurements. However, for some entities, the application of this
Statement will change current practices. This Statement is effective for
financial statements for fiscal years beginning after November 15, 2007. Earlier
application is permitted provided that the reporting entity has not yet issued
financial statements for that fiscal year. The adoption of FASB No. 157did not
have a material impact on the financial statements of the Company.
In December 2006, the FASB approved FASB Staff Position "FSP" No. EITF 00-19-2,
"Accounting for Registration Payment Arrangements" ("FSP EITF 00-19-2"), which
specifies that the contingent obligation to make future payments or otherwise
transfer consideration under a registration payment arrangement, whether issued
as a separate agreement or included as a provision of a financial instrument or
other agreement, should be separately recognized and measured in accordance with
SFAS No. 5, "Accounting for Contingencies". FSP EITF 00-19-2 also requires
additional disclosure regarding the nature of any registration payment
arrangements, alternative settlement methods, the maximum potential amount of
consideration and the current carrying amount of the liability, if any. The
guidance in FSP EITF 00-19-2 amends FASB Statements No. 133, "Accounting for
Derivative Instruments and Hedging Activities", and No. 150, "Accounting for
Certain Financial Instruments with Characteristics of both Liabilities and
Equity", and FASB Interpretation No. 45, "Guarantor's Accounting and Disclosure
requirement for Guarantees, Including Indirect Guarantees of Indebtedness of
Others", to include scope exceptions for registration payment arrangements. FSP
EITF 00-19-2 is effective immediately for registration payment arrangements and
the financial instruments subject to those arrangements that are entered into or
modified subsequent to the issuance date of this FSP, or for financial
statements issued for fiscal years beginning after December 15, 2006, and
interim periods within those fiscal years, for registration payment arrangements
entered into prior to the issuance date of this FSP. The Company is currently
evaluating the impact, if any of this FSP, on the Company's financial position,
results of operations or cash flows.
30
In February 2007, the FASB issued SFAS No. 159, "The Fair Value Option for
Financial Assets and Financial Liabilities-including an amendment of FAS 115"
"Statement 159". Statement 159 allows entities to choose, at specified election
dates, to measure eligible financial assets and liabilities at fair value that
are not otherwise required to be measured at fair value. If a company elects the
fair value option for an eligible item, changes in that item's fair value in
subsequent reporting periods must be recognized in current earnings. Statement
159 is effective for fiscal years beginning after November 15, 2007. We are
currently evaluating the potential impact of Statement 159 on our financial
statements. We do not expect the impact will be material.
Other accounting standards that have been issued or proposed by the FASB or
other standards-setting bodies that do not require adoption until a future date
are not expected to have a material impact on the consolidated financial
statements upon adoption.
ITEM 4. CONTROLS AND PROCEDURES
(A) Evaluation of Disclosure Controls And Procedures
As of the end of the period covered by this Quarterly Report, the Company
carried out an evaluation, under the supervision and with the participation of
the Company's Principal Executive Officer and Principal Accounting and Financial
Officer, of the effectiveness of the design and operation of the Company's
disclosure controls and procedures. The Company's disclosure controls and
procedures are designed to provide a reasonable level of assurance of achieving
the Company's disclosure control objectives. The Company's Principal Executive
Officer and Principal Accounting and Financial Officer have concluded the
Company's disclosure controls and procedures are, in fact, effective at this
reasonable assurance level as of the period covered. In addition, the Company
reviewed its internal controls, and there have been no significant changes in
its internal controls or in other factors that could significantly affect those
controls subsequent to the date of their last evaluation or from the end of the
reporting period to the date of this Quarterly Report on Form 10-Q.
(B) Changes in Internal Controls Over Financial Reporting
In connection with the evaluation of the Company's internal controls during the
Company's last fiscal quarter covered by this Quarterly Report, the Company's
Principal Executive Officer and Principal Accounting and Financial Officer have
determined there are no changes to the Company's internal controls over
financial reporting that has materially affected, or is reasonably likely to
materially effect, the Company's internal controls over financial reporting.
31
PART II
OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are, from time to time, involved in various legal proceedings in the ordinary
course of our business. While it is impossible to predict accurately or to
determine the eventual outcome of these matters, the Company believes the
outcome of these proceedings will not have a material adverse effect on the
financial statements of the Company.
ITEM 1A. RISK FACTORS
You should carefully consider the risks described below before purchasing our
common stock. Our most significant risks and uncertainties are described below;
however, they are not the only risks we face. If any of the following risks
actually occur, our business, financial condition, or results of operations
could be materially adversely affected, the trading of our common stock could
decline, and you may lose all or part of your investment therein. You should
acquire shares of our common stock only if you can afford to lose your entire
investment.
RISK ASSOCIATED WITH OUR BUSINESS
We Have A Limited Operating History
Prior to the Samaritan and Pharmaplaz's Research, Development and
Commercialization Collaboration Agreement, we had limited operating history and
our revenue had not been sufficient to sustain our operations. We have incurred
annual operating losses over various years and as a result, at June 30, 2007, we
had an accumulated deficit of $40,960,489. Our future profitability will require
the successful commercialization of our marketed drugs in Greece and Eastern
Europe as well as the out-licensing of our internal development programs in
Alzheimer's, Cancer Cardiovascular disease and Infectious Diseases. Currently,
the Company has in-licensed ten products to be marketed and distributed in our
Eastern Europe territories. No assurances can be given when this will occur or
when we will become profitable.
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We Will Require Additional Financing To Sustain Our Operations And Without It
We May Not Be Able To Continue Operations. We Cannot
Currently Access Funds Under The Purchase Agreement
II.
We had an operating cash flow deficit of $6.25 million for the year ended
December 31, 2006 and $4.64 million for the year ended December 31, 2005.
The availability of funds under the Purchase Agreement II with Fusion Capital is
subject to many conditions, some of which are predicated on events that are not
within our control. Accordingly, we cannot guarantee that these capital
resources will be sufficient to fund our business operations.
Under the Purchase Agreement II agreement, we have set a minimum purchase price
("floor price") of $1.50. Fusion Capital shall not have the right or the
obligation to purchase shares of our Common Stock on any business day that the
market price of our common stock is below $1.50. On August 2, 2007, the last
reported market sale price of our common stock was $1.15. Accordingly, the
Company cannot currently access funds under the Purchase Agreement II and will
not be able to access such funds in the future unless the market price our
common stock exceeds $1.50 per share.
Assuming a minimum purchase price of $1.50 per share and the purchase by Fusion
Capital of the full 368,229 remaining shares under the Purchase Agreement II,
the remaining proceeds to us would be $552,344 unless we choose to register more
than 368,229 shares, which we have the right, but not the obligation, to do. In
the event we elect to sell more than the 368,229 shares, we will be required to
file a new Registration Statement and have it declared effective by the U.S.
Securities & Exchange Commission.
If we continue to be unable to access funds under the Purchase Agreement II, we
may need to sell additional equity securities in private placements. As of June
30, 2007, with 234,895 remaining available under the Registration Statement, the
selling price of our common stock to Fusion Capital will have to average at
least $151.13 per share for us to receive the remaining proceeds of $35,499,999
without registering additional shares of Common Stock. Shares issued through
June 30, 2007 under the Common Stock Purchase Agreement are 2,265,105, with
proceeds of $4,500,001. In second quarter 2007, the Company received $200,000 in
exchange for the issuance of 133,334 shares to Fusion Capital.
32
The number of shares ultimately offered for sale by Fusion Capital is dependent
upon the number of shares purchased by Fusion Capital under the Purchase
Agreement II. We have the right to receive $40,000 per trading day under the
Purchase Agreement II, unless our stock price equals or exceeds $1.50, in which
case the daily amount may be increased under certain conditions as the price of
our common stock increases.
The extent to which we rely on Fusion Capital as a source of funding will depend
on a number of factors, including the prevailing market price of our common
stock (which must exceed $1.50 per share) and the extent to which we are able to
secure working capital from other sources. Even if we are able to access the
full amounts under Purchase Agreement II with Fusion Capital, we may still need
additional capital to fully implement our business, operating and development
plans. If we are unable to obtain additional financing, we might be required to
delay, scale back or eliminate selected research and product development
programs or clinical trials, or be required to license third parties to
commercialize products or technologies that we would otherwise undertake
ourselves, or cease certain operations all together. However, any of these
options might have a material adverse effect upon the Company. If we raise
additional funds by issuing equity securities, dilution to stockholders may
result, and new investors could have rights superior to existing holders of
shares. Should the financing we require to sustain our working capital needs be
unavailable or prohibitively expensive when we require it, the consequences
would have a material adverse effect on our business, operating results,
financial condition and prospects.
------------------------------------------------------------------------
The Sale Of Our Common Stock To Fusion Capital May Cause Dilution And The Sale
Of The Shares Of Common Stock Acquired By Fusion Capital And Other Shares
Registered for Selling Stockholders Could Cause The Price Of Our Common Stock
To Decline
In connection with entering into the Purchase Agreement II with Fusion Capital,
we authorized the sale to Fusion Capital of up to 4,440,517 shares of our common
stock and registered 2,783,334. The number of shares ultimately offered for sale
by Fusion Capital is dependent upon the number of shares purchased by Fusion
Capital under the agreement. The purchase price for the common stock to be sold
pursuant to the Purchase Agreement II will fluctuate based on the price of our
common stock. Depending upon market liquidity at the time, a sale of shares by
Fusion Capital at any given time could cause the trading price of our common
stock to decline. Fusion Capital may ultimately purchase all, some or none of
the 2,783,334shares of common stock registered under the Purchase Agreement II.
Further, the lower the stock price, the more shares we would have to sell to
Fusion Capital to receive the same proceeds. After it has acquired such shares,
Fusion Capital may sell all, some or none of such shares registered under the
accompanying Registration Statement. Therefore, sales to Fusion Capital by us
under the Purchase Agreement II may result in substantial dilution to the
interests of other holders of our common stock. The sale of a substantial number
of shares of our common stock by Fusion Capital, or anticipation of such sales,
could make it more difficult for us to sell equity or equity-related securities
in the future at a time and at a price that we might otherwise wish to effect
sales. However, we have the right to control the timing and amount of any sales
of our shares of common stock to Fusion Capital and the Purchase Agreement II
may be terminated by us at any time at our discretion without any cost to us.
Further, the sale by Fusion Capital of our common stock will increase the number
of our publicly traded shares, which could depress the market price of our
common stock. Moreover, the mere prospect of resales by Fusion Capital and other
selling stockholders as contemplated in the prospectus filed January 26, 2007
could depress the market price for our common stock. The issuance of shares to
Fusion Capital under the Purchase Agreement II, will dilute the equity interest
of existing stockholders and could have an adverse effect on the market price of
our common stock.
33
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The Company's License Agreements May Be Terminated In The Event Of A Breach
The license agreements pursuant to which the Company has licensed its core
technologies for its potential drug products permit the licensors, including
Georgetown University and George Washington University, to terminate such
agreements under certain circumstances, such as the failure by the licensee to
use its reasonable best efforts to commercialize the subject drug or the
occurrence of any uncured material breach by the licensee. The license
agreements also provide that the licensor is primarily responsible for obtaining
patent protection for the licensed technology, and the licensee is required to
reimburse the licensor for costs it incurs in performing these activities. The
license agreements also require the payment of specified royalties. Any
inability or failure to observe these terms or pay these costs or royalties may
result in the termination of the applicable license agreement in certain cases.
The termination of any license agreement could force us to curtail our business
operations.
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Protecting Our Proprietary Rights Is Difficult and Costly
The patent positions of pharmaceutical companies can be highly uncertain and
involve complex legal and factual questions. The license agreements also provide
that the licensor is primarily responsible for obtaining patent protection for
the licensed technology, and the licensee is required to reimburse the licensor
for costs it incurs in performing these activities. Accordingly, we cannot
predict the breadth of claims allowed in these companies' patents or whether the
Company may infringe or be infringing on these claims. Patent disputes are
common and could preclude the commercialization of our products. Patent
litigation is costly in its own right and could subject us to significant
liabilities to third parties. In addition, an adverse decision could force us to
either obtain third-party licenses at a material cost or cease using the
technology or product in dispute.
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Our Success Will Depend On Our Ability To Attract And Retain Key Personnel
In order to execute our business plan, we need to attract, retain and motivate a
significant number of highly qualified managerial, technical, financial and
sales personnel. If we fail to attract and retain skilled scientific and
marketing personnel, our research and development and sales and marketing
efforts will be hindered. Our future success depends to a significant degree
upon the continued services of key management personnel, including Dr. Janet
Greeson, our Chief Executive Officer, President and Chairman of the Board of
Directors, and Dr. Vassilios Papadopoulos, Chief Scientist of the Science of
Technology Advisory Committee and our key consultant. We do not maintain key man
insurance on either of these individuals. The loss of their services could delay
our product development programs and our research and development efforts at the
Research Centre of McGill University. In addition, the loss of Dr. Greeson is
grounds for our Research Collaboration with Research Centre of McGill University
to terminate. In addition, competition for qualified employees among companies
in the biotechnology and biopharmaceutical industry is intense and we cannot be
assured that we would be able to recruit qualified personnel on commercially
acceptable terms, or at all, to replace them.
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The Company's Success Will Be Dependent Upon The Licenses And Proprietary
Rights It Receives From Other Parties, And On Any Patents It May Obtain
The Company and Samaritan Therapeutics, Canada, has signed a Research
Collaboration and Licensing Agreement with The Research Institute of McGill
University Health Centre (RI-MUHC) in Montreal, Canada, to advance its promising
pipeline into clinical trial status and develop new innovative drug candidates.
Once drug candidates, derived from the collaborative research, are
clinically-validated and deemed to hold promise, Samaritan Therapeutics will
continue to develop the drug candidate in Canada, while Samaritan
Pharmaceuticals will focus on the drug candidate's process through regulatory
agencies and its commercialization throughout the rest of the world.
34
Our success will depend in large part on the ability of the Company and its
licensors to (a) maintain license and patent protection with respect to their
drug products, (b) defend patents and licenses once obtained, (c) maintain trade
secrets, (d) operate without infringing upon the patents and proprietary rights
of others and (e) obtain appropriate licenses to patents or proprietary rights
held by third parties if infringement should otherwise occur, both in the United
States and in foreign countries. We have obtained licenses to patents and other
proprietary rights from Georgetown University and George Washington University.
The patent positions of pharmaceutical companies, including those of the
Company, are uncertain and involve complex legal and factual questions. There is
no guarantee the Company or its licensors have or will develop or obtain the
rights to products or processes that are patentable, that patents will issue
from any of the pending applications or that claims allowed will be sufficient
to protect the technology licensed to the Company. In addition, we cannot be
certain that any patents issued to or licensed by the Company will not be
challenged, invalidated, infringed or circumvented, or that the rights granted
thereunder will provide competitive disadvantages to the Company.
Litigation, which could result in substantial cost, may also be necessary to
enforce any patents to which the Company has rights, or to determine the scope,
validity and unenforceability of other parties' proprietary rights, which may
affect the rights of the Company. U.S. patents carry a presumption of validity
and generally can be invalidated only through clear and convincing evidence.
There can be no assurance that our licensed patents would be held valid by a
court or administrative body or an alleged infringer would be found to be
infringing. The mere uncertainty resulting from the institution and continuation
of any technology-related litigation or interference proceeding could have an
adverse material effect on the Company pending resolution of the disputed
matters.
We may also rely on unpatented trade secrets and expertise to maintain its
competitive position, which it seeks to protect, in part, by confidentiality
agreements with employees, consultants and others. There can be no assurance
these agreements will not be breached or terminated, that we will have adequate
remedies for any breach or that trade secrets will not otherwise become known or
be independently discovered by competitors.
Samaritan has terminated the Georgetown research collaboration under this
Agreement with a 60-day notice because Dr. Papadopoulos' ceased to be the
Principal Investigator or have responsibility for directing our collaborated
research. Each license granted or to be granted from Georgetown to Samaritan was
not terminated or in any way affected when the research collaboration between
Georgetown University and Samaritan was terminated at the end of the second
quarter of 2007. Each such license has its own termination provisions as set
forth in the respective license.
----------------------------------------------------------------------
We Are Faced With Intense Competition And Industry Changes,
Which May Make It More Difficult For Us To Achieve Significant
Market Penetration.
The pharmaceutical and biotech industry generally is characterized by rapid
technological change, changing customer needs, and frequent new product
introductions. If our competitors' existing products or new products are more
effective than or considered superior to our products, the commercial
opportunity for our products will be reduced or eliminated. We face intense
competition from companies in our marketplace as well as companies offering
other treatment options. Many of our potential competitors are significantly
larger than we are and have greater financial, technical, research, marketing,
sales, distribution and other resources than we do. We believe there will be
intense price competition for products developed in our markets. Our competitors
may develop or market technologies and products that are more effective or
commercially attractive than any that we are developing or marketing. Our
competitors may obtain regulatory approval, and introduce and commercialize
products before we do. These developments could force us to curtail or cease or
business operations. Even if we are able to compete successfully, we may not be
able to do so in a profitable manner.
----------------------------------------------------------------------
If We Are Unable To Continue Product Development, Our Business Will Suffer
Our growth depends in part on continued ability to successfully develop our
products. We may experience difficulties that could delay or prevent the
successful development and commercialization of these products. Our products in
development may not prove safe and effective in clinical trials. Clinical trials
may identify significant technical or other obstacles that must be overcome
before obtaining necessary regulatory or reimbursement approvals. In addition,
our competitors may succeed in developing commercially viable products that
render our products obsolete or less attractive. Failure to successfully develop
and commercialize new products and enhancements would likely have a significant
negative effect on our financial prospects.
35
----------------------------------------------------------------------
There Is No Assurance That Our Products Will Have Market Acceptance
The success of the Company will depend in substantial part on the extent to
which a drug product, once approved, achieves market acceptance. The degree of
market acceptance will depend upon a number of factors, including (a) the
receipt and scope of regulatory approvals, (b) the establishment and
demonstration in the medical community of the safety and efficacy of a drug
product, (c) the product's potential advantages over existing treatment methods
and (d) reimbursement policies of government and third party payers. We cannot
predict or guarantee physicians, patients, healthcare insurers, maintenance
organizations, or the medical community in general, will accept or utilize any
drug product of the Company. If our products do not develop market acceptance,
we will be forced to curtail or cease our business operations.
----------------------------------------------------------------------
There Is Uncertainty Relating To Third-Party Reimbursement,
Which Is Critical To Market Acceptance Of Our Products.
International market acceptance of our products may depend, in part, upon the
availability of reimbursement within prevailing health care payment systems.
Reimbursement and health care payment systems in international markets vary
significantly by country, and include both government sponsored health care and
private insurance. We may not obtain international reimbursement approvals in a
timely manner, if at all. Our failure to receive international reimbursement
approvals may negatively impact market acceptance of our products in the
international markets in which those approvals are sought and could force us to
curtail or cease our business operations.
From time to time significant attention has been focused on reforming the health
care system in the United States and other countries. Any changes in Medicare,
Medicaid or third-party medical expense reimbursement, which may arise from
health care reform, may have a material adverse effect on reimbursement for our
products or procedures in which our products are used and may reduce the price
we are able to charge for our products. In addition, changes to the health care
system may also affect the commercial acceptance of products we are currently
developing and products we may develop in the future.
36
----------------------------------------------------------------------
If We Fail To Protect Our Licensed Intellectual Property Rights, Our
Competitors May Take Advantage Of Our Ideas And Compete Directly Against Us.
Our success will depend to a significant degree on our ability to secure and
protect intellectual property rights and to enforce patent and trademark
protections relating to our technology which we license. From time to time,
litigation may be advisable to protect our intellectual property position.
However, these legal means afford only limited protection and may not adequately
protect our rights or permit us to gain or keep any competitive advantage. Any
litigation in this regard could be costly, and it is possible that we will not
have sufficient resources to fully pursue litigation or to protect our other
intellectual property rights. It could result in the rejection or invalidation
of our existing and future patents. Any adverse outcome in litigation relating
to the validity of our patents, or any failure to pursue litigation or otherwise
to protect our patent position, could force us to curtail or cease our business
operations. Also, even if we prevail in litigation, the litigation would be
costly in terms of management distraction as well as in terms of money. In
addition, confidentiality agreements with our employees, consultants, customers,
and key vendors may not prevent the unauthorized disclosure or use of our
technology. It is possible that these agreements could be breached or that they
might not be enforceable in every instance, and that we might not have adequate
remedies for any such breach. Enforcement of these agreements may be costly and
time consuming. Furthermore, the laws of foreign countries may not protect our
intellectual property rights to the same extent as the laws of the United
States.
----------------------------------------------------------------------
We May Be Sued For Allegedly Violating The Intellectual Property Rights
Of Others.
The pharmaceutical industry has in the past been characterized by a substantial
amount of litigation and related administrative proceedings regarding patents
and intellectual property rights. In addition, major pharmaceutical companies
have used litigation against emerging growth companies as a means of gaining or
preserving a competitive advantage.
Should third parties file patent applications or be issued patents claiming
technology also claimed by us in pending applications, we may be required to
participate in interference proceedings in the United States Patent and
Trademark Office to determine the relative priorities of our inventions and the
third parties' inventions. We could also be required to participate in
interference proceedings involving our issued patents and pending applications
of another entity. An adverse outcome in an interference proceeding could
require us to cease using the technology or to license rights from prevailing
third parties and force us to curtail or cease our business operations.
Third parties may claim we are using their patented inventions and may go to
court to stop us from engaging in our normal operations and activities. These
lawsuits are expensive to defend and conduct and would also consume and divert
the time and attention of our management. A court may decide that we are
infringing a third party's patents and may order us to cease the infringing
activity. A court could also order us to pay damages for the infringement. These
damages could be substantial and could have a material adverse effect on our
business, financial condition, results of operations and cash flows. An adverse
outcome on an infringement claim could force us to curtail or cease our business
operations.
If we are unable to obtain any necessary license following an adverse
determination in litigation or in interference or other administrative
proceedings, we would have to modify our products to avoid infringing a third
party's patent and could temporarily or permanently have to discontinue
manufacturing and selling some of our products. If this were to occur, it would
negatively impact future sales and, in turn, our business, financial condition,
results of operations and cash flows, which could force us to curtail or cease
our business operations.
37
----------------------------------------------------------------------
If We Fail To Obtain Or Maintain Necessary Regulatory Clearances
Or Approvals For Products, Or If Approvals Are Delayed Or
Withdrawn, We Will Be Unable To Commercially Distribute And
Market Our Products Or Any Product Modifications.
Government regulation has a significant impact on our business. Government
regulation in the United States and other countries is a significant factor
affecting the research and development, manufacture and marketing of our
products. In the United States, the Food and Drug Administration "FDA" has broad
authority under the federal Food, Drug and Cosmetic Act to regulate the
distribution, manufacture and sale of pharmaceutical products. The process of
obtaining FDA and other required regulatory clearances and approvals is lengthy
and expensive. We may not be able to obtain or maintain necessary approvals for
clinical testing or for the manufacturing or marketing of our products. Failure
to comply with applicable regulatory approvals can, among other things, result
in fines, suspension or withdrawal of regulatory approvals, product recalls,
operating restrictions, and criminal prosecution. In addition, governmental
regulations may be established which could prevent, delay, modify or rescind
regulatory approval of our products. Any of these actions by the FDA, or change
in FDA regulations, could have a material adverse effect on our business,
financial condition, results of operations and cash flows.
Regulatory approvals, if granted, may include significant limitations on the
indicated uses for which our products may be marketed. In addition, to obtain
such approvals, the FDA and foreign regulatory authorities may impose numerous
other requirements on us. FDA enforcement policy prohibits the marketing of
approved medical devices for unapproved uses. In addition, product approvals can
be withdrawn for failure to comply with regulatory standards or unforeseen
problems following initial marketing. We may not be able to obtain or maintain
regulatory approvals for our products on a timely basis, or at all, and delays
in receipt of or failure to receive such approvals, the loss of previously
obtained approvals, or failure to comply with existing or future regulatory
requirements could have a material adverse effect on our business, financial
condition, results of operations and cash flows, which could force us to curtail
or cease our business operations.
----------------------------------------------------------------------
Positive Results In Preclinical And Early Clinical Trials Do Not Ensure Future
Clinical Trials Will Be Successful Or Drug Candidates Will Receive
Any Necessary Regulatory Approvals For The Marketing, Distribution Or
Sale Of Such Drug Candidates.
Success in preclinical and early clinical trials does not ensure that
large-scale clinical trials will be successful. Clinical results are frequently
susceptible to varying interpretations, delaying, limiting or preventing
regulatory approvals. The length of time necessary to complete clinical trials
and submit an application for marketing approval for a final decision by a
regulatory authority varies significantly and may be difficult to predict.
----------------------------------------------------------------------
If We Become Subject To Product Liability Claims, We May Be Required To
Pay Damages That Exceed Our Insurance Coverage.
Our business exposes us to potential product liability claims that are inherent
in the testing, production, marketing and sale of pharmaceuticals products.
While we maintain a commercial general liability policy for $2 million, we may
not be able to maintain insurance in amounts or scope sufficient to provide us
with adequate coverage. A claim in excess of our insurance coverage would have
to be paid out of cash reserves, which could have a material adverse effect on
our business, financial condition, results of operations and cash flows and
force us to curtail or cease our business operations. In addition, any product
liability claim likely would harm our reputation in the industry and our ability
to develop and market products in the future.
----------------------------------------------------------------------
Insurance Coverage Is Increasingly More Difficult To Obtain or Maintain
Obtaining insurance for our business, property and products is increasingly more
costly and narrower in scope, and we may be required to assume more risk in the
future. If we are subject to third party claims or suffer a loss or damage in
excess of our insurance coverage, we may be required to share that risk in
excess of our insurance limits. Furthermore, any first-or-third-party claims
made on any of our insurance policies may impact our ability to obtain or
maintain insurance coverage at reasonable costs or at all in the future.
38
----------------------------------------------------------------------
We Are Dependent On Third Parties For A Significant Portion Of Our Bulk
Supply And The Formulation, Fill And Finish Of Our Product
Candidates.
We currently produce a substantial portion of clinical product candidates'
supply at our collaborative partner's Ireland manufacturing facility. However,
we also depend on third parties for a significant portion of our product
candidates' bulk supply as well as for some of the formulation, fill and finish
of product candidates that we manufacture. Pharmaplaz is our third-party
contract manufacturer of product candidates' bulk drug; accordingly, our
clinical supply of product candidates is currently significantly dependent on
Pharmaplaz's production schedule for product candidates. We would be unable to
produce product candidates in sufficient quantities to substantially offset
shortages in Pharmaplaz's scheduled production if Pharmaplaz or other
third-party contract manufacturers used for the formulation, fill and finish of
product candidates bulk drug were to cease or interrupt production or services
or otherwise fail to supply materials, products or services to us for any
reason, including due to labor shortages or disputes, regulatory requirements or
action or contamination of product lots or product recalls. We cannot guarantee
that an alternative third-party contract manufacturer would be available on a
timely basis or at all. This in turn could materially reduce our ability to
satisfy demand for product candidates, which could materially and adversely
affect our operating results.
----------------------------------------------------------------------
Our Corporate Compliance Program Cannot Guarantee That We Are In Compliance
With All Potentially Applicable U.S. Federal And State
Regulations And All Potentially Applicable Foreign Regulations.
The development, manufacturing, distribution, pricing, sales, marketing and
reimbursement of our products, together with our general operations, is subject
to extensive federal and state regulation in the United States and to extensive
regulation in foreign countries. While we have developed and instituted a
corporate compliance program based on what we believe to be current best
practices, we cannot assure you that we or our employees are or will be in
compliance with all potentially applicable U.S. federal and state regulations
and/or laws or all potentially applicable foreign regulations and/or laws. If we
fail to comply with any of these regulations and/or laws a range of actions
could result, including, but not limited to, the termination of clinical trials,
the failure to approve a product candidate, restrictions on our products or
manufacturing processes, including withdrawal of our products from the market,
significant fines, exclusion from government healthcare programs or other
sanctions or litigation.
RISKS ASSOCIATED WITH AN INVESTMENT IN OUR COMMON STOCK
If We Do Not Show Progress Consistent With Our Compliance Plan, There Is
No Assurance That Our Stock Will Not Be Delisted From The
American Stock Exchange ("AMEX", the "Exchange").
On April 3, 2007, the American Stock Exchange ("AMEX") notified Samaritan
Pharmaceuticals, Inc. that its listing on the AMEX exchange is being continued
pursuant to an extension to demonstrate that it has regained compliance with the
continued listing standards in Section 1003(a)(ii) and (iii) of the AMEX Company
Guide. The Company believes it has addressed Section 1003(f)(v) of the AMEX
Company Guide.
Previously on November 6, 2006 and on January 30, 2007 , the AMEX Listing
Qualifications staff notified the Company it no longer complies with the
Exchange's continued listing standard due to its shareholder's equity of less
than $4 million and losses from continuing operations and/or losses in three out
of its four most recent fiscal years, as set forth in Section 1003(a)(ii) of the
Company Guide; with its shareholder's equity of less than $6 million from
continuing operations and/or net losses in its five most recent fiscal years, as
set forth in Section 1003(a)(iii) of the Company Guide; and with its low selling
price, as set forth in Section 1003(f)(v) of the Company Guide.
39
The Company is required by the AMEX to provide periodic reports showing progress
consistent with the Company's compliance plan. If the Company does not show
progress consistent with our compliance plan, the Staff will review the
circumstances and may immediately commence delisting proceedings. Thus, there is
no assurance that the Company will be able to maintain continued listing on the
AMEX.
----------------------------------------------------------------------
The Market Price Of Our Common Stock Is Highly Volatile.
The market price of our common stock has been and is expected to continue to be
highly volatile. Various factors, including announcements of technological
innovations by us or other companies, regulatory matters, new or existing
products or procedures, concerns about our financial position, operating
results, litigation, government regulation, developments or disputes relating to
agreements, patents or proprietary rights may have a significant impact on the
market price of our stock. If our operating results are below the expectations
of securities analysts or investors, the market price of our common stock may
fall abruptly and significantly.
Future sales of our common stock, including shares issued upon the exercise of
outstanding options and warrants or hedging or other derivative transactions
with respect to our stock, could have a significant negative effect on the
market price of our common stock. These sales also might make it more difficult
for us to sell equity securities or equity-related securities in the future at a
time and price that we would deem appropriate.
We entered into registration rights agreements in connection with Fusion Capital
and other financings pursuant to which we agreed to register for resale by the
investors the shares of common stock issued. Sales of these shares could have a
material adverse effect on the market price of our shares of common stock. . If
obtaining sufficient financing from Fusion Capital were to prove unavailable or
prohibitively dilutive and if we are unable to sell enough of our products, we
may need to secure another source of funding in order to satisfy our working
capital needs.
----------------------------------------------------------------------
Under Provisions Of The Company's Articles Of Incorporation, Bylaws And
Nevada Law, The Company's Management May Be Able To Block Or
Impede A Change In Control
The issuance of blank check preferred stock, where the Board of Directors can
designate rights or preferences, may make it more difficult for a third party to
acquire, or may discourage a third party from acquiring, a majority of our
voting stock. These and other provisions in our Articles of Incorporation
(restated as last amended June 10, 2005) and in our Bylaws (restated as last
amended April 18, 2005), as well as certain provisions of Nevada law, could
delay or impede the removal of incumbent directors and could make it more
difficult to effect a merger, tender offer or proxy contest involving a change
of control of the Company, even if such events could be beneficial to the
interest of the shareholders as a whole. Such provisions could limit the price
that certain investors might be willing to pay in the future for our common
stock.
----------------------------------------------------------------------
Officers and Directors Liabilities Are Limited Under Nevada Law
Pursuant to the Company's Articles of Incorporation (restated as last amended
June 10, 2005) and Bylaws (restated as last amended April 18, 2005), and as
authorized under applicable Nevada law, Directors are not liable for monetary
damages for breach of fiduciary duty, except in connection with a breach of the
duty of loyalty for (a) acts or omissions not in good faith or which involve
intentional misconduct or a knowing violation of law, (b) for dividend payments
or stock repurchases illegal under applicable Nevada law or (c) any transaction
in which a Director has derived an improper personal benefit. The Company's
Articles of Incorporation (restated as last amended June 10, 2005) and Bylaws
(restated as last amended April 18, 2005) provide that the Company must
indemnify its officers and Directors to the fullest extent permitted by
applicable Nevada law for all expenses incurred in the settlement of any actions
against such persons in connection with their having served as officers or
Directors.
40
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Securities, were sold by the Company in the second quarter of 2007
under an exemption from registration. These shares of common stock were sold for
cash, unless otherwise noted in this section, and were sold in private
transactions to persons believed to be of a class of private investors acting on
their own comprised of accredited investors (as such term is defined in
Regulation D of the SEC) and a limited number of non-accredited investors. All
investors, to the best knowledge of the Company, are not affiliated with the
Company and purchased the shares with apparent investment intent. The Company
relied upon, among other possible exemptions, Section 4(2) of the Securities Act
of 1933 (the "Securities Act"), as amended. Its reliance on said exemption was
based upon the fact no public solicitation was used by the Company in the offer
or sale, and the securities were legended shares, along with a notation at the
respective transfer agent, restricting the shares from sale or transfer as is
customary with reference to Rule 144 of the Securities Act. During the quarter
ended June 30, 2007, the Company issued an aggregate of 116,677 shares of common
stock in consideration of services to be rendered to the Company during 2007.
Such shares were valued at an aggregate of $157,500 with an average price of
$1.35 per share.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
The Company has formed, by the determination of the Board, an Audit Committee
with Independent Director Mr. H. Thomas Winn as Chairman. Mr. Winn is a
qualified financial expert, such a term is used in Item 7(d)(3)(iv) of Schedule
14A (240.14a-101 of this chapter) under the Exchange Act of 1934, as amended,
(the "Exchange Act"). The Company has also formed a Compensation and Governance
Committee, with Independent Director, Ms. Cynthia C. Thompson as Chairman; a
Nomination Committee with Independent Director Mr. Welter Holden as Chairman;
and a Science and Technology Advisory Committee with Dr. Vassilios Papadopoulos
as Chief Scientist and Key Consultant to the Board. It should also be noted that
no director or executive officer, key employee or key consultant of the Company
has any family relationships with any other director, executive officer, key
employee or key consultant of the Company, except Mr. Eugene Boyle, our Chief
Financial Officer and Chief Operating Officer, is the son of Dr. Janet Greeson.
On May 30, 2006 the Board of Directors of Samaritan approved and adopted the
Change in Control Severance Plan for Certain Covered Executives and Employees of
Samaritan Pharmaceuticals (the "Plan"), effective May 30, 2006. The Plan is
intended to help avoid the loss and distraction of certain key employees of the
Company in the event of a change in control. The Plan has an initial term of
three years with automatic three-year extensions, unless terminated by the Board
at least six (6) months prior to the end of the then current term.
41
The Chief Executive Officer, Chief Operating Officer, Senior Vice Presidents,
Vice Presidents, and Directors are eligible to participate in the Plan, and the
Board may designate other employees of the Company as Plan participants. The
Company shall pay or cause to be paid to the participant a cash severance
calculated based on a multiplier of four (4) months of base salary for every
year of service up to maximum in of either twenty four (24) months or thirty six
(36) months depending on the participants job title or job category. The
severance amount equals the applicable multiplier times the sum of (A) the
Participant's highest annual rate of base salary as reported on the
participant's W-2 for employee or on the participant's 1099 for directors within
the thirty six (36) month period immediately preceding the Effective Date of the
change in control and (B) the participant's maximum annual target bonus in
effect upon the date of the change in control under the Company's bonus plan or
the Participant's actual earned commission incentive for the last two quarters,
which will be annualized, prior to the change in Control, not to exceed the
target at 100% of achievement as defined in the Company's Sales Incentive Plan
in effect upon the date of the change in control.
The Plan provides that, if, within three years following a "change in control"
(as defined in the Plan), a participant's employment is terminated by the
Company without "cause" (as defined in the Plan) or by the participant for "good
reason" (as defined in the Plan), the participant is eligible for severance
benefits equal to a multiple of the sum of the participant's base salary and the
higher of the participant's target bonus opportunity during the year in which
the change in control occurs or his or her target bonus opportunity following
the change in control. Each participant will also receive his or her salary
through the date of termination, a pro rata target bonus payment for the year in
which the termination occurs, a pro rata long-term incentive payment to the
extent provided in the Company's Long Term Incentive Plan, and any earned but
unpaid long-term incentive payments or annual bonuses. In the event that a
participant becomes subject to an excise tax under section 280G of the Internal
Revenue Code of 1986, as amended, the participant will generally be entitled to
receive an additional amount such that the participant is placed in the same
after-tax position as if no excise tax had been imposed. The Plan may be amended
by the Board at any time, except that no amendment that adversely affects the
rights or potential rights of a participant will be effective in the event that
a change in control occurs within three (3) year of such amendment.
On May 30, 2006, the Board of Directors of Samaritan approved and adopted
indemnification agreement forms for certain covered executives and employees of
Samaritan. The Company has entered into indemnification agreements with each of
its current directors and certain of its executive officers. At present, there
is no pending litigation or proceeding involving a director, officer or employee
of the Company regarding which indemnification is sought, nor is the Company
aware of any threatened litigation that may result in claims for
indemnification.
On August 9, 2007, the Board of Directors of Samaritan Pharmaceuticals, Inc.
amended Article V, Section 2 of the Company's bylaws to allow the shares of the
Company's capital stock to be either certificated or uncertificated, or a
combination thereof. This change in the bylaws was required in order for the
Company to be eligible to participate in the Direct Registration System ("DRS").
Under a new AMEX rule approved by the Securities Exchange Commission in late
2006, the Company is required to be "DRS eligible" no later than January 1,
2008. Participation in the DRS will allow the Company's shareholders to
establish, either through the Company's transfer agent or a broker dealer, a
book entry position on the stock record books of the Company and to
electronically transfer shares of the Company's stock without the delivery of
physical certificates.
ITEM 6. EXHIBITS
Listed below are all exhibits filed as part of this Quarterly Report on Form
10-Q. Some exhibits are filed by the Company with the SEC pursuant to Rule
12b-32 under the Exchange Act.
--------------- -------------------------------------- ------------------------------------------------------
EXHIBIT NO. DESCRIPTION LOCATION
--------------- -------------------------------------- ------------------------------------------------------
3.1 Articles of Incorporation, restated Provided herewith
as last amended July 5, 2007
--------------- -------------------------------------- ------------------------------------------------------
3.2 Bylaws, restated as last amended Provided herewith
August 9, 2007
--------------- -------------------------------------- ------------------------------------------------------
4.1 Form of Common Stock Certificate Incorporated by reference to Exhibit 4.1 to the
Company's Current Report Form 10-SB12G as filed with
the U.S. Securities and Exchange Commission on July
21, 1999.
--------------- -------------------------------------- ------------------------------------------------------
4.2 Amended Samaritan Pharmaceuticals, Incorporated by reference to Exhibit 4.2 to the
Inc. 2001 Stock Option Plan Company's Quarterly Report on Form 10-QSB as filed
with the U.S. Securities and Exchange Commission on
August 16, 2004.
42
--------------- -------------------------------------- ------------------------------------------------------
4.3 Samaritan Pharmaceuticals, Inc. 2005 Incorporated by reference to Schedule 14-A
Stock Option Plan Information Statement as filed with the U.S.
Securities and Exchange
Commission on April 29,
2005 and approved by the
shareholders on June 10,
2005.
--------------- -------------------------------------- ------------------------------------------------------
10.1 Research, Development and Incorporated by reference to Exhibit 10.1 to the
Commercialization Collaboration Company's Form 10-K as filed with the U.S.
Agreement for SP-01A dated March 28, Securities and Exchange Commission on April 13,
2007 by and between Pharmaplaz and 2007.
the Company.
--------------- -------------------------------------- ------------------------------------------------------
10.2 Common Stock Purchase Agreement Incorporated by reference to Exhibit 10.1 to the
(Purchase Agreement I), dated April Company's Current Report on Form 8-K as filed with
22, 2003, by and between the Company the U.S. Securities and Exchange Commission on April
and Fusion Capital Fund II, LLC 25, 2003.
--------------- -------------------------------------- ------------------------------------------------------
10.3 Registration Rights Agreement, dated Incorporated by reference to Exhibit 10.2 to the
April 22, 2003, by and between the Company's Current Report on Form 8-K as filed with
Company and Fusion Capital Fund II, the U.S. Securities and
Exchange Commission on April LLC 25, 2003.
--------------- -------------------------------------- ------------------------------------------------------
10.4 Employment Agreement, dated as of Incorporated by reference to Exhibit 10.6 to the
January 1, 2001, by and between Company's Quarterly Report on Form 10-QSB as filed
Samaritan Pharmaceuticals, Inc. and with the U.S. Securities and Exchange Commission on
Mr. Thomas Lang. August 16, 2004.
--------------- -------------------------------------- ------------------------------------------------------
10.5 Form of Trust Under Samaritan Incorporated by reference to Exhibit 10.10 to the
Pharmaceuticals, Inc. Deferred Company's Quarterly Report on Form 10-QSB as filed
Compensation Plan with the U.S. Securities and Exchange Commission on
August 14, 2002.
--------------- -------------------------------------- ------------------------------------------------------
10.6 Master Clinical Trial and Full Scale Incorporated by reference to Exhibit 10.10 to the
Manufacturing Agreement, dated Company's Quarterly Report on Form 10-QSB as filed
October 5, 2004, by and between the with the U.S. Securities and Exchange Commission on
Company and Pharmaplaz, LTD November 15, 2004.
--------------- -------------------------------------- ------------------------------------------------------
10.7 Common Stock Purchase Agreement Incorporated by reference to Exhibit 10.11 to the
(Purchase Agreement II), dated May Company's Quarterly Report on Form 10-QSB as filed
12, 2005, by and between the Company with the U.S. Securities and Exchange Commission on
and Fusion Capital Fund II, LLC May 13, 2005.
--------------- -------------------------------------- ------------------------------------------------------
10.8 Amendment to Common Stock Purchase Incorporated by reference to Exhibit 10.12 to the
Agreement, dated December 19, 2005, Company's Registration Statement on Form SB-2 as
by and between the Company and filed with the U.S. Securities and Exchange
Fusion Capital Fund II, LLC Commission on December 15, 2005.
--------------- -------------------------------------- ------------------------------------------------------
10.9 Registration Rights Agreement, dated Incorporated by reference to Exhibit 10.12 to the
May 12, 2005, by and between the Company's Quarterly Report on Form 10-QSB as filed
Company and Fusion Capital Fund II, with the U.S. Securities and
Exchange Commission on LLC May 13, 2005.
--------------- -------------------------------------- ------------------------------------------------------
10.10 Norbrook Supply Agreement Incorporated by reference to Exhibit 1 to the
Company's Current Report on Form 8-K as filed with
the U.S. Securities and Exchange Commission on
September 27, 2005.
--------------- -------------------------------------- ------------------------------------------------------
10.11 Research Collaboration and Licensing Incorporated by reference to Exhibit 10.10 to the
Agreement, dated June 8, 2001, by Company's Registration Statement on Form SB-2 as
and between Georgetown University filed with the U.S. Securities and Exchange
and Samaritan Pharmaceuticals, Inc. Commission on July 30, 2003.
43
--------------- -------------------------------------- ------------------------------------------------------
10.12 Change in Control Severance Plan Incorporated by reference to Exhibit 10.16 to the
for Certain Covered Executives and Company's Quarterly Report on Form 10-Q as filed
Employees of Samaritan with the U.S. Securities and Exchange Commission on
Pharmaceuticals, Inc. August 14, 2006.
--------------- -------------------------------------- ------------------------------------------------------
10.13 Samaritan Pharmaceuticals, Inc.'s Incorporated by reference to Exhibit 10.17 to the
Director/Officer's Indemnification Company's Quarterly Report on Form 10-Q as filed
Agreement with the U.S. Securities and Exchange Commission on
August 14, 2006.
--------------- -------------------------------------- ------------------------------------------------------
10.14 Stock Purchase Agreement among Incorporated by reference to Exhibit 10.18 to the
Samaritan Pharmaceuticals, Company's Quarterly Report on Form 10-Q as filed
Metastatin Pharmaceuticals, and the with the U.S. Securities and Exchange Commission on
shareholders of Metastatin November 14, 2006.
Pharmaceuticals.
--------------- -------------------------------------- ------------------------------------------------------
10.15 Samaritan Pharmaceuticals, Incorporated by reference to Exhibit 10.15 to the
Inc.'s In-Licensing Company's Quarterly Report on Form 10-Q as filed
Agreement with Three Rivers with the U.S. Securities and Exchange Commission on
Pharmaceuticals. May 21, 2007.
--------------- -------------------------------------- ------------------------------------------------------
10.16 Samaritan Pharmaceuticals, Incorporated by reference to Exhibit 10.16 to the
Inc.'s Company's Quarterly Report on Form 10-Q as filed
In-Licensing Agreement with Molteni with the U.S. Securities and Exchange Commission on
dated January 1, 2007. May 21, 2007.
--------------- -------------------------------------- ------------------------------------------------------
10.17 Pharmaplaz Research, Development and Incorporated by reference to Exhibit 10.1 to the
Commercialization Collaboration Company's Quarterly Report on Form 8-K as filed with
Agreement the SEC on March 28, 2007.
--------------- -------------------------------------- ------------------------------------------------------
10.18 Pharmaplaz Research, Development and Incorporated by reference to Exhibit 10.18 to the
Commercialization Collaboration Company's Quarterly Report on Form 10-Q as filed
Agreement Supplement with the U.S. Securities and Exchange Commission on
May 21, 2007.
--------------- -------------------------------------- ------------------------------------------------------
10.19 Research Collaboration and Licensing Incorporated by reference to Exhibit 99.2 to the
Agreement by and between The Company's Current Report on Form 8-K as filed with
Research Centre at McGill the U.S. Securities and Exchange Commission on July
University, Samaritan Therapeutics, 25, 2007.
Inc. and Samaritan Pharmaceuticals,
Inc.
--------------- -------------------------------------- ------------------------------------------------------
10.20 Cooperative Lock Up Agreement Incorporated by reference to Exhibit 99.2 to the
between Samaritan Pharmaceuticals, Company's Current Report on Form 8-K as filed with
Inc. and Doug Bessert and KD1, Inc. the U.S. Securities and Exchange Commission on June
12, 2007.
--------------- -------------------------------------- ------------------------------------------------------
14.1 The Samaritan Pharmaceuticals, Inc. Incorporated by reference to Exhibit 14.1 to the
Code of Conduct Company's Form 10-KSB as filed with the U.S.
Securities and Exchange
Commission on April 15, 2003.
--------------- -------------------------------------- ------------------------------------------------------
21 List of Subsidiaries Incorporated by reference to Exhibit 21 to the
Company's Quarterly
Report on Form 10-QSB as
filed with the U.S.
Securities and Exchange
Commission on August 15,
2005.
--------------- -------------------------------------- ------------------------------------------------------
23.1 Consent of Independent Registered Incorporated by reference to Exhibit 23.1 to the
Public Accounting Firm Company's Registration Statement on Form SB-2 as
filed with the U.S. Securities and Exchange
Commission on December 15, 2005.
--------------- -------------------------------------- ------------------------------------------------------
23.2 Consent of Nevada Counsel Incorporated by reference to Exhibit 23.2 to the
Company's Registration Statement on Form SB-2 as
filed with the U.S. Securities and Exchange
Commission on December 15, 2005.
--------------- -------------------------------------- ------------------------------------------------------
31.1 Certification of Chief Executive Provided herewith
Officer re: Section 302
44
--------------- -------------------------------------- ------------------------------------------------------
31.2 Certification of Chief Financial Provided herewith
Officer re: Section 302
--------------- -------------------------------------- ------------------------------------------------------
32.1 Certification of Chief Executive Provided herewith
Officer re: Section 906
--------------- -------------------------------------- ------------------------------------------------------
32.2 Certification of Chief Financial Provided herewith
Officer re: Section 906
--------------- -------------------------------------- ------------------------------------------------------
(B) Current Reports on Form 8-K Filed During The Quarter Ended June 30, 2007
None.
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused
this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
SAMARITAN PHARMACEUTICALS, INC
Dated: August 13, 2007
By: /s/ Eugene Boyle
---------------------------------
Eugene Boyle,
Chief Financial Officer, Director