UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One) | |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2002
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 000-23143
PROGENICS
PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE |
13-3379479 |
(State or other jurisdiction
of incorporation or organization) |
(I.R.S.
Employer Identification No.) |
777 Old Saw Mill River Road Tarrytown, New York |
10591 |
(Address of principal
executive offices) |
(Zip Code) |
(914) 789-2800
(Registrant’s telephone number, including
area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No
As of November 8, 2002 there were 12,634,184 shares of common stock, par value $.0013 per share, of the registrant outstanding.
PROGENICS PHARMACEUTICALS, INC.
INDEX
. | ||
PART I - FINANCIAL INFORMATION | ||
Item 1. Financial Statements | Page No | |
3 | ||
4 | ||
5 | ||
6 | ||
7 | ||
11 | ||
15 | ||
15 | ||
PART II - OTHER INFORMATION | ||
Item 6. Exhibits and Reports on Form 8-K | 17 | |
Certifications | 19 |
2
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements:
PROGENICS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
AT SEPTEMBER 30, 2002 AND DECEMBER 31, 2001 (Unaudited)
September
30, 2002 |
December
31, 2001 |
|||||||
ASSETS: | |
|
||||||
Current assets: | ||||||||
Cash
and cash equivalents |
$ | 7,170,796 | $ | 10,759,636 | ||||
Certificates
of deposit |
1,750,000 | |||||||
Marketable
securities |
32,785,469 | 30,523,239 | ||||||
Accounts
receivable |
241,674 | 378,020 | ||||||
Interest
receivable |
900,253 | 1,245,890 | ||||||
Other
current assets |
1,125,684 | 840,695 | ||||||
Total
current assets |
43,973,876 | 43,747,480 | ||||||
Marketable securities | 5,719,660 | 20,594,274 | ||||||
Fixed
assets, at cost, net of accumulated depreciation and amortization |
3,622,962 | 2,560,199 | ||||||
Investment in joint venture | 270,939 | 579,296 | ||||||
Restricted cash | 121,284 | |||||||
Total
assets |
$ | 53,708,721 | $ | 67,481,249 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY: | ||||||||
Current liabilities: | ||||||||
Accounts
payable and accrued liabilities |
$ | 1,797,461 | $ | 2,597,089 | ||||
Amount
due to joint venture |
500,000 | |||||||
Total
current liabilities |
1,797,461 | 3,097,089 | ||||||
Deferred lease liability | 63,147 | 38,797 | ||||||
Total
liabilities |
1,860,608 | 3,135,886 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred
stock, $.001 par value, 20,000,000 authorized; none issued and outstanding |
||||||||
Common
stock - $.0013 par value, 40,000,000 authorized; issued and outstanding
- 12,615,932 in 2002 and 12,429,916 in 2001 |
16,401 | 16,159 | ||||||
Additional paid-in capital | 91,012,654 | 89,664,075 | ||||||
Unearned compensation | (23,150 | ) | ||||||
Accumulated deficit | (39,287,269 | ) | (25,518,834 | ) | ||||
Accumulated other comprehensive income | 106,327 | 207,113 | ||||||
Total
stockholders’ equity |
51,848,113 | 64,345,363 | ||||||
Total
liabilities and stockholders’ equity |
$ | 53,708,721 | $ | 67,481,249 | ||||
The accompanying notes are an integral part of these financial statements.
3
PROGENICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
For the three
months ended September 30, |
For the nine
months ended September 30, |
|||||||||||||
Revenues: | 2002 | 2001 | 2002 | 2001 | ||||||||||
Contract research and development from joint venture |
$ | 1,817,042 | $ | 3,901,298 | ||||||||||
Other contract research and development |
$ | 305,874 | 193,734 | $ | 4,709,726 | |||||||||
Research grants |
916,029 | 1,072,355 | 3,642,650 | 2,876,724 | ||||||||||
Product sales |
8,921 | 9,000 | 28,260 | 37,000 | ||||||||||
Interest income |
390,162 | 923,847 | 1,409,509 | 1,941,140 | ||||||||||
|
||||||||||||||
Total
revenues |
3,132,154 | 2,311,076 | 9,175,451 | 9,564,590 | ||||||||||
|
||||||||||||||
Expenses: | ||||||||||||||
Research and development |
6,656,787 | 3,456,919 | 17,089,313 | 10,479,113 | ||||||||||
General and administrative |
1,598,831 | 1,000,109 | 4,608,020 | 4,162,006 | ||||||||||
Loss in joint venture |
999,932 | 707,482 | 2,108,357 | 1,645,449 | ||||||||||
Interest expense |
12,371 | 36,138 | ||||||||||||
Depreciation and amortization |
288,898 | 176,033 | 738,196 | 513,180 | ||||||||||
|
||||||||||||||
Total
expenses |
9,544,448 | 5,352,914 | 24,543,886 | 16,835,886 | ||||||||||
|
||||||||||||||
Operating
loss |
(6,412,294 | ) | (3,041,838 | ) | (15,368,435 | ) | (7,271,296 | ) | ||||||
Payment from insurance settlement | 1,600,000 | |||||||||||||
Payment from collaborator | 9,852,012 | |||||||||||||
|
||||||||||||||
Net
income (loss) |
$ | (6,412,294 | ) | $ | (3,041,838 | ) | $ | (13,768,435 | ) | $ | 2,580,716 | |||
|
||||||||||||||
Net income (loss) per share - basic | $ | (0.51 | ) | $ | (0.25 | ) | $ | (1.10 | ) | $ | 0.21 | |||
|
|
|||||||||||||
Net income (loss) per share - diluted | $ | (0.51 | ) | $ | (0.25 | ) | $ | (1.10 | ) | $ | 0.19 | |||
The accompanying notes are an integral part of these financial statements.
4
PROGENICS
PHARMACEUTICALS, INC.
CONDENSED
STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE NINE MONTHS ENDED SEPTEMBER
30, 2002 (Unaudited)
COMMON STOCK | ADDITIONAL PAID-IN CAPITAL |
UNEARNED
COMPENSATION |
ACCUMULATED DEFICIT |
ACCUMULATED OTHER COMPREHENSIVE INCOME |
TOTAL
STOCKHOLDERS’ EQUITY |
COMPREHENSIVE (LOSS) |
|||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||
Balance
at December 31, 2001 |
12,429,916 | $ | 16,159 | $ | 89,664,075 | $ | (23,150) | $ | (25,518,834) | $ | 207,113 | $ | 64,345,363 | ||||||||||||
Amortization
of unearned compensation |
23,150 | 23,150 | |||||||||||||||||||||||
Issuance
of compensatory stock options |
232,579 | 232,579 | |||||||||||||||||||||||
Sale
of common stock under employee stock purchase plans and exercise of stock
options and warrants |
186,016 | 242 | 1,116,000 | 1,116,242 | |||||||||||||||||||||
Net loss | (13,768,435 | ) | (13,768,435 | ) | (13,768,435 | ) | |||||||||||||||||||
Change
in unrealized gain on marketable securities |
(100,786 | ) | (100,786 | ) | (100,786 | ) | |||||||||||||||||||
Balance
at September 30, 2002 |
12,615,932 | $ | 16,401 | $ | 91,012,654 | $ | (39,287,269) | $ | 106,327 | $ | 51,848,113 | $ | (13,869,221) | ||||||||||||
|
The accompanying notes are an integral part of these financial statements.
5
PROGENICS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
Nine months
ended September 30,
|
||||||||
2002 | 2001 | |||||||
Cash flows from operating activities: | |
|
|
|||||
Net
income (loss) |
$ | (13,768,435 | ) | $ | 2,580,716 | |||
Adjustments
to reconcile net income (loss) to net cash provided by (used in) operating
activities: |
||||||||
Depreciation
and amortization |
738,196 | 513,180 | ||||||
Amortization
of discounts, net of premiums, on marketable securities |
927,184 | 207,407 | ||||||
Amortization
of discount on amount due to joint venture |
32,058 | |||||||
Loss
in joint venture |
2,108,357 | 1,645,449 | ||||||
Noncash
expenses incurred in connection with issuance of common stock, stock options
and warrants |
255,729 | 404,912 | ||||||
Changes
in assets and liabilities: |
||||||||
Decrease
in accounts receivable |
136,346 | 1,730,935 | ||||||
Decrease
in prepaid expenses and other assets |
60,648 | 245,967 | ||||||
Decrease
in accounts payable and accrued expenses |
(1,425,172 | ) | (471,277 | ) | ||||
Increase
in investment in LLC |
(2,300,000 | ) | (1,689,077 | ) | ||||
Increase
in deferred lease liability |
24,350 | |||||||
Total adjustments |
525,638 | 2,619,554 | ||||||
Net
cash (used in) provided by operating activities |
(13,242,797 | ) | 5,200,270 | |||||
Cash flows from investing activities: | ||||||||
Capital
expenditures |
(1,175,415 | ) | (923,145 | ) | ||||
Sales
of marketable securities |
22,095,000 | 30,575,000 | ||||||
Purchase
of marketable securities |
(10,510,586 | ) | (25,899,264 | ) | ||||
Increase
in restricted cash |
(121,284 | ) | ||||||
Sale
of certificate of deposit |
1,000,000 | |||||||
Purchase
of certificate of deposit |
(1,750,000 | ) | ||||||
Net
cash provided by investing activities |
8,537,715 | 4,752,591 | ||||||
Cash flows from financing activities: | ||||||||
Proceeds
from the exercise of stock options and warrants and other adjustments
to stockholders’ equity |
1,116,242 | 784,115 | ||||||
Payment
of capital lease obligations |
(5,681 | ) | ||||||
Net
cash provided by financing activities |
1,116,242 | 778,434 | ||||||
Net
(decrease) increase in cash and cash equivalents |
(3,588,840 | ) | 10,731,295 | |||||
Cash and cash equivalents at beginning of period | 10,759,636 | 5,628,987 | ||||||
Cash
and cash equivalents at end of period |
$ | 7,170,796 | $ | 16,360,282 | ||||
|
||||||||
Supplemental
disclosure of noncash investing and financing activities: |
||||||||
Fixed
assets included in accounts payable and accrued expenses |
$ | 650,896 | $ | 89,331 | ||||
The accompanying notes are an integral part of these financial statements.
6
PROGENICS PHARMACEUTICALS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
1. Interim Financial Statements
The interim Condensed Financial Statements of Progenics Pharmaceuticals, Inc. (the “Company”) have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all information and disclosures necessary for a presentation of the Company’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles. In the opinion of management, these financial statements reflect all adjustments, consisting only of normal recurring accruals, necessary for a fair presentation of the Company’s financial position, results of operations and cash flows for such periods. The results of operations for interim periods are not necessarily indicative of the results for the full year. The December 31, 2001 Condensed Balance Sheet data was derived from audited financial statements, but as set forth herein does not include all disclosures required by generally accepted accounting principles. These financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2001.
2. Accounts Payable and Accrued Expenses
Accounts payable and accrued expenses as of September 30, 2002 and December 31, 2001 consist of the following:
September 30,
2002 |
December
31, 2001 |
||||||
Accounts payable | $ | 1,319,477 | $ | 916,711 | |||
Accrued
consulting and clinical trial costs |
165,364 | 703,508 | |||||
Accrued
payroll and related costs |
165,775 | 543,283 | |||||
Accrued
legal and auditing fees payable |
146,845 | 433,587 | |||||
|
|||||||
$ | 1,797,461 | $ | 2,597,089 | ||||
|
3. Net (Loss) Income Per Share
The Company’s basic (loss) net income per share amounts have been computed by dividing net (loss) income by the weighted average number of common shares outstanding during the respective periods. For the three and nine months ended September 30, 2002 and for the three months ended September 30, 2001, the Company reported net losses and, therefore, no common stock equivalents were included in the computation of diluted per share amounts since such inclusion would have been antidilutive. For the nine months ended September 30, 2001, the Company reported net income and, therefore, all common stock equivalents with exercise prices less than the average fair market value of the Company’s Common Stock for the period have been included in the calculation, as follows:
7
Net (Loss) Income
(Numerator) |
Shares (Denominator) |
Per Share Amount |
||||||||
2002: | ||||||||||
Three months ended September 30, 2002: | ||||||||||
Basic and Diluted: | $ | (6,412,294 | ) | 12,572,519 | $ | (0.51 | ) | |||
Nine months ended September 30, 2002: | ||||||||||
Basic and Diluted: | $ | (13,768,435 | ) | 12,521,322 | $ | (1.10 | ) | |||
|
||||||||||
2001: | ||||||||||
Three months ended September 30, 2001: | ||||||||||
Basic and Diluted: | $ | (3,041,838) | 12,398,746 | $ | (0.25) | |||||
|
||||||||||
Nine months-ended September 30, 2001: | ||||||||||
Basic: | $ | 2,580,716 | 12,361,773 | $ | 0.21 | |||||
Effect of Dilutive Securities: | |
|||||||||
Options
|
1,517,158 | |||||||||
Warrants |
63,389 | |||||||||
Diluted: | $ | 2,580,716 | 13,942,320 | $ | 0.19 | |||||
Options and warrants which have been excluded from the diluted per share amounts because their effect would have been antidilutive include the following:
Three Months Ended September 30, | ||||||||||||
2002 | 2001 | |||||||||||
Wtd. Avg. Number |
Wtd.
Avg. Exercise Price |
Wtd.
Avg. Number |
Wtd.
Avg. Exercise Price |
|||||||||
4,543,640 | $8.98 | 3,685,458 | $10.74 | |||||||||
Nine Months Ended September 30, | ||||||||||||
2002 | 2001 | |||||||||||
Wtd. Avg. Number |
Wtd. Avg. Exercise Price |
Wtd. Avg. Number |
Wtd. Avg. Exercise Price |
|||||||||
4,229,517 | $8.68 | 310,423 | $30.20 |
4. PSMA Development Company LLC
The Company accounts for its investment in the 50% owned PSMA Development Company LLC (“JV”) in accordance with the equity method of accounting. During the fourth quarter of 2001, the Company surpassed the $3.0 million threshold for its funding of costs for research and development conducted by the Company on behalf of the JV. The Company recognizes contract research and development revenue for all amounts earned for research and development services rendered to the JV beyond that threshold. For the three and nine months ended September 30, 2002, the Company recognized approximately $1,817,000 and $3,901,000, respectively, of contract research and development revenue for services performed on behalf of the JV. The level of future revenues from the JV will be dependent upon the extent of research and development services requested by the JV, the future financial position of the JV and the form and content of subcontractor arrangements entered into by the JV.
8
Statement of Operations Data: 5. Collaboration
Payment In
May 2001, the Company and Bristol-Myers Squibb Company (“BMS”)
agreed to terminate their Joint Development and Master License Agreement to
develop vaccines to treat melanoma and other cancers (the “BMS Agreement”),
entered into in April 1997. Under the terms of the settlement agreement, BMS
relinquished all future rights to products resulting from the BMS Agreement.
In connection with the termination of the BMS Agreement, BMS paid the Company
$15.5 million. Approximately $5.6 million of the payment related to contract
work performed prior to termination and the $9.9 million balance was a contract
termination payment. Under the terms of certain license agreements, a portion
of the termination payment was paid to certain licensors. 6. Insurance
Settlement In
the first quarter of 2002, the Company received a $1.6 million insurance settlement
in connection with a casualty loss that had occurred in 2001. 7. Comprehensive
(Loss) Income Comprehensive
(loss) income represents the change in net assets of a business enterprise
during a period from transactions and other events and circumstances from
non-owner sources. Comprehensive (loss) income of the Company includes net
(loss) income adjusted for the change in net unrealized gain or loss on marketable
securities. The net effect of income taxes on comprehensive (loss) income
is immaterial. For the three months and nine months ended September 30, 2002
and 2001, the components of comprehensive (loss) income are: 8. Income
Taxes For
the year ended December 31, 2001, the Company recorded a net loss and the
effect of income taxes was immaterial. Accordingly, no provision for income
taxes was recorded for the period ended September 30, 2001. 9 9. Recently
Issued Accounting Standards In
April 2002, the Financial Accounting Standards Board issued Statement on Financial
Accounting Standards No. 145 (“FAS 145”) “Rescission of
FASB Statements No. 4, 44, and 64, Amendment of FASB Statement No. 13, and
Technical Corrections as of April 2002”. As a result, the accounting
for gains and losses from extinguishment of debt and sale-leaseback transactions
will be affected by FAS 145. The provisions of this Statement related to the
rescission of Statement 4, 44 and 64 shall be applied in fiscal years beginning
after May 15, 2002. The provisions of this Statement related to Statement
13 shall be effective for transactions occurring after May 15, 2002.
In
June 2002, the Financial Accounting Standards Board issued Statement on Financial
Accounting Standards No. 146 (“FAS 146”) “Accounting for
Costs Associated with Exit or Disposal Activities”. FAS 146 nullifies
Emerging Issues Task Force Issue No. 94-3, “Liability Recognition for
Certain Employee Termination Benefits and Other Costs to Exit an Activity
(including Certain Costs Incurred in a Restructuring).” FAS 146 requires
that a liability for a cost associated with an exit or disposal activity be
recognized when the liability is incurred rather than on the date of an entity’s
commitment to an exit plan and establishes that fair value is the objective
for initial measurement of the liability. The provisions of this Statement
shall be effective for exit or disposal activities initiated after December
31, 2002. The provisions of Issue 94-3 shall continue to apply for an exit
activity initiated under an exit plan that met the criteria of Issue 94-3
prior to this Statement’s initial application. Management
believes that the future adoption of these accounting standards will not have
a material impact on the Company’s financial statements. 10 Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS Certain
statements in this Form 10-Q constitute “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act of 1995
(the “Reform Act”). Such forward-looking statements involve known
and unknown risks, uncertainties and other factors which may cause the actual
results, performance or achievements of the Company, or industry results,
to be materially different from any expected future results, performance,
or achievements expressed or implied by such forward-looking statements. Such
factors include, among others, the following: technological uncertainties
related to early stage product development, uncertainties associated with
preclinical and clinical testing, risks relating to corporate collaborations,
the lack of product revenue and the uncertainty of future profitability, the
need for additional financing and other factors set forth more fully in the
Company’s Annual Report on Form 10-K for the fiscal year ended December
31, 2001 and other periodic filings with the Securities and Exchange Commission
to which investors are referred for further information. General
Three
Months Ended September 30,
Nine
Months Ended September 30,
2002
2001
2002
2001
Total revenue
$
6,528
$
10,712
$
10,234
$
36,404
Total expenses (1)
2,006,392
853,431
4,226,948
1,888,224
Net loss (2)
$
(1,999,864
)
$
(842,719
)
$
(4,216,714
)
$
(1,851,820
)
(1)
Includes contract research and development
services performed by the Company.
(2)
The terms of the joint venture agreement provide
for the Company to fund up to $3.0 million in certain costs of the joint
venture. During 2001, prior to reaching the $3.0 million threshold, the
loss resulting from such costs was allocated to the capital account of the
Company and accordingly, the Company’s allocated share of the joint
venture’s loss was greater than its ownership interest.
Three
Months Ended September 30,
Nine
Months Ended September 30,
2002
2001
2002
2001
Net (loss) income
$
(6,412,294
)
$
(3,041,838
)
$
(13,768,435
)
$
2,580,716
(15,588
)
595,144
(100,786
)
751,731
$
(6,427,882
)
$
(2,446,694
)
$
(13,869,221
)
$
3,332,447
Progenics is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to address the unmet medical needs of patients with debilitating conditions and life-threatening diseases. The Company commenced principal operations in late 1988 and since that time has been engaged primarily in research and development efforts, development of it’s manufacturing capabilities, establishment of corporate collaborations and raising capital. In order to commercialize the principal products that the Company has under development, the Company will need to address a number of technological challenges and comply with comprehensive regulatory requirements. Accordingly, it is not possible to predict the amount of funds that will be required or the length of time that will pass before the Company receives revenues from sales of any of its products. To date, product sales have consisted solely of limited revenues from the sale of research reagents. The Company expects that sales of research reagents in the future will not significantly increase over current levels. The Company’s other sources of revenues through September 30, 2002 have been payments received under its collaboration agreements and from the Company’s joint venture with Cytogen Corp., research grants and contracts related to the Company’s cancer and HIV programs and interest income.
To date, a majority of the Company’s expenditures have been for research and development activities. The Company expects that its research and development expenses will increase significantly as its programs progress and the Company makes filings for related regulatory approvals. With the exception of the years ended December 31, 1997 and 1998, the Company has had recurring losses and had, at September 30, 2002, an accumulated deficit of approximately $39,287,000. The Company will require additional funds to complete the development of its products, to fund the cost of clinical trials, and to fund operating losses that are expected to continue for the foreseeable future. The Company does not expect its products under development to be commercialized in the near future.
Results of Operations
Three Months Ended September 30, 2002 and 2001
Contract research and development revenue from joint venture increased to approximately $1,817,000 for the three months ended September 30, 2002 from $0 for the three months ended September 30, 2001. The Company recognizes revenue for research and development services performed for the PSMA Development Company, LLC, the Company’s joint venture with Cytogen Corporation, (the “JV”). No such revenue was recognized in the third quarter of 2001 because the Company was required to fund the first $3.0 million of research and development costs and such amounts were recorded as capital contributions to the JV. That threshold was reached in the fourth quarter of 2001. Other contract research and development revenue decreased to zero for the three months ended September 30, 2002 from approximately $306,000 for the three months ended September 30, 2001. The Company did not perform any contract research and development services in the third quarter of 2002 other than that for the JV. Revenues from research grants decreased to approximately $916,000 for the three months ended September 30, 2002 from approximately $1,072,000 for the three months ended September 30, 2001. The decrease resulted from the funding of a fewer number of grants. Interest income decreased to approximately $390,000 for the three months ended September 30, 2002 from approximately $924,000 for the three months ended September 30, 2001 as cash available for investment decreased and was subject to lower interest rates in 2002.
11
Research and development expenses increased to approximately $6,657,000 for the three months ended September 30, 2002 from approximately $3,457,000 for the three months ended September 30, 2001. The increase was principally due to an increase in headcount, related laboratory supplies and additional rent for new laboratory space as the Company expanded its research and development programs to include MNTX (methylnaltrexone) and increased spending in the PSMA programs.
General and administrative expenses increased to approximately $1,599,000 for the three months ended September 30, 2002 from approximately $1,000,000 for the three months ended September 30, 2001. The increase was principally due to an increase in professional fees for legal and patent work and an increase in headcount, related benefits and operating expenses.
Loss in joint venture increased to approximately $1,000,000 for the three months ended September 30, 2002 from approximately $707,000 for the three months ended September 30, 2001. The Company recognizes its share of the loss under the terms of the joint venture with Cytogen Corporation. The increase was due to an increase in the headcount assigned to the PSMA project and the related cost of supplies. Additionally, prior to reaching the $3.0 million threshold, the Company recognized 100% of the joint venture’s research and development expenses; that percentage was reduced to 50% subsequent to reaching that threshold in December 2001.
Interest expense decreased to $0 for the three months ended September 30, 2002 from approximately $12,000 for the three months ended September 30, 2001. The decrease was due to the payoff of the remaining capital leases outstanding.
Depreciation expense increased to approximately $289,000 for the three months ended September 30, 2002 from approximately $176,000 for the three months ended September 30, 2001 as new capital equipment was purchased and leasehold improvements were incurred in connection with the Company’s growth.
The Company’s net loss for the three months ended September 30, 2002 was approximately $6,412,000 compared to net income of approximately $3,042,000 for the three months ended September 30, 2001.
Nine Months Ended September 30, 2002 and 2001
12
Research and development expenses increased to approximately $17,089,000 for the nine months ended September 30, 2002 from approximately $10,479,000 for the nine months ended September 30, 2001. The increase was principally due to an increase in headcount, related laboratory supplies and additional rent for new laboratory space as the Company expanded its research and development programs to include MNTX (methylnaltrexone) and increased spending in its PSMA programs.
General and administrative expenses increased to approximately $4,608,000 for the nine months ended September 30, 2002 from approximately $4,162,000 for the nine months ended September 30, 2001. The increase was principally due to a decrease in professional fees for legal and patent work and an increase in headcount, related benefits and operating expenses.
Loss in joint venture increased to approximately $2,108,000 for the nine months ended September 30, 2002 from approximately $1,645,000 for the nine months ended September 30, 2001. The Company recognizes its share of the loss under the terms of the joint venture with Cytogen Corporation. The increase was due to an increase in the headcount assigned to the PSMA project and the related cost of supplies. Additionally, prior to reaching the $3.0 million threshold, the Company recognized 100% of the joint venture’s research and development expenses; that percentage was reduced to 50% subsequent to reaching that threshold in December 2001.
Interest expense decreased to $0 for the nine months ended September 30, 2002 from approximately $36,000 for the nine months ended September 30, 2001. The decrease was due to the payoff of the remaining capital leases outstanding.
Depreciation expense increased to approximately $738,000 for the nine months ended September 30, 2002 from approximately $513,000 for the nine months ended September 30, 2001 as new capital equipment was purchased and leasehold improvements were incurred in connection with the Company’s growth.
In the first nine months of 2002, the Company received a $1.6 million insurance settlement in connection with a casualty loss that had occurred in 2001. The Company also received a non-recurring payment of approximately $9,852,000 from BMS during the second quarter of 2001 in connection with the termination of the collaboration.
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The Company’s net loss for the nine months ended September 30, 2002 was approximately $13,768,000 compared to net income of approximately $2,581,000 for the nine months ended September 30, 2001.
Liquidity and Capital Resources
We have funded our operations since inception primarily through private placements of equity securities, loans that were subsequently converted into equity securities, a line of credit that was repaid and terminated, payments received under collaboration agreements, such as those with BMS and Roche, two public offerings of common stock, funding under government research grants and contracts, interest on investments, and the proceeds from the exercise of outstanding options and warrants. In May 2001, the Company and BMS mutually agreed to terminate our cancer vaccine collaborative development agreement, and as a result we regained all rights to the products and received a non-recurring payment of approximately $9,852,000 from BMS. As a result of the termination of the BMS Agreement, the Company will receive no additional payments from BMS.
At September 30, 2002, we had cash, cash equivalents and marketable securities, including non-current portion, totaling approximately $47,426,000 compared with approximately $61,877,000 at December 31, 2001. For the nine months ended September 30, 2002, net cash used in operating activities was approximately $13.2 million. The Company had approximately $24.5 million of expenses, including research and development of $17.1 million, general and administrative of $4.6 million and a decrease in accounts payable and accrued expenses of $1.4 million, offset by total revenues of $10.8 million comprised of $4.1 of contract research development revenue, $3.6 of revenue from government grants, $1.4 million of interest income, and $1.6 million from the settlement of an insurance claim. The Company is required to fund 50% of the current and future spending on the PSMA projects under the terms of the JV. Such amount was approximately $2.3 million during the first nine months of 2002. Net cash provided by investing activities was approximately $8.5 million resulting from the sale of marketable securities offset by capital expenditures of approximately $1.2 million as we have acquired additional space and our facility lease has been extended to June 2005. Net cash provided by financing activities was approximately $1.1 million due to the exercise of stock options under the Company’s Employee Stock Option Plans, the exercise of warrants and the sale of common stock under the Employee Stock Purchase Plans.
For the three and nine months ended September 30, 2002, the Company recognized approximately $1,817,000 and $3,901,000, respectively, of contract research and development revenue for services performed on behalf of the JV. The level of future revenues from the JV will be dependent upon the extent of research and development services requested by the JV, the future financial position of the JV and the form and content of subcontractor arrangements entered into by the JV.
We have no off-balance sheet arrangements and do not guarantee the obligations of any other entity.
We believe that our existing capital resources should be sufficient to fund operations at least through 2003. However, this is a forward-looking statement based on our current operating plan and the assumptions on which it relies. There could be changes that would consume our assets before such time. We will require substantial funds to conduct research and development activities, preclinical studies, clinical trials and other activities relating to the commercialization of any potential products. In addition, our cash requirements may vary materially from those now planned because of results of research and development and product testing, changes in existing relationships with, or new relationships with, licensees, licensors or other collaborators, changes in the focus and direction of our research and development programs, competitive and technological advances, the cost of filing, prosecuting, defending and enforcing patent claims, the regulatory approval process, manufacturing and marketing and other costs associated with the commercialization of products following receipt of regulatory approvals and other factors. We have no committed external sources of capital and, as discussed above, expect no significant product revenues for a number of years as it will take at least that much time, if ever, to bring our products to the commercial marketing stage. We may seek additional financing, such as through future offerings of equity or debt securities or agreements with corporate partners and collaborators with respect to the development of our technology, to fund future operations. We cannot assure you, however, that we will be able to obtain additional funds on acceptable terms, if at all.
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Recently Issued Accounting Standards
In April 2002, the Financial Accounting Standards Board issued Statement on Financial Accounting Standards No. 145 (“FAS 145”) “Rescission of FASB Statements No. 4, 44, and 64, Amendment of FASB Statement No. 13, and Technical Corrections as of April 2002”. As a result, the accounting for gains and losses from extinguishment of debt and sale-leaseback transactions will be affected by FAS 145. The provisions of this Statement related to the rescission of Statement 4, 44 and 64 shall be applied in fiscal years beginning after May 15, 2002. The provisions of this Statement related to Statement 13 shall be effective for transactions occurring after May 15, 2002.
In June 2002, the Financial Accounting Standards Board issued Statement on Financial Accounting Standards No. 146 (“FAS 146”) “Accounting for Costs Associated with Exit or Disposal Activities”. FAS 146 nullifies Emerging Issues Task Force Issue No. 94-3, “Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring).” FAS 146 requires that a liability for a cost associated with an exit or disposal activity be recognized when the liability is incurred.rather than on the date of an entity’s commitment to an exit plan and establishes that fair value is the objective for initial measurement of the liability. The provisions of this Statement shall be effective for exit or disposal activities initiated after December 31, 2002. The provisions of Issue 94-3 shall continue to apply for an exit activity initiated under an exit plan that met the criteria of Issue 94-3 prior to this Statement’s initial application.
Management believes that the future adoption of these accounting standards will not have a material impact on the Company’s financial statements.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Our primary investment objective is to preserve principal while maximizing yield without significantly increasing our risk. Our investments consist of taxable auction securities, euro dollar bonds, and corporate notes. Our investments totaled $38.5 million at September 30, 2002. Approximately $31.5 million of these investments had fixed interest rates, and $7.0 million had interest rates that were variable.
Due to the conservative nature of our short-term fixed interest rate investments, we do not believe that we have a material exposure to interest rate risk. Our fixed interest rate long-term investments are sensitive to changes in interest rates. Interest rate changes would result in a change in the fair value of these investments due to differences between the market interest rate and the rate at the date of purchase of the investment. A 100 basis point increase in the September 30, 2002 market interest rates would result in a decrease of approximately $0.20 million in the market values of these investments.
Item 4. Controls and Procedures
The Company maintains “disclosure controls and procedures”, as such term is defined under Exchange Act Rules13a-14(c) and 15d-14, that are designed to ensure that information required to be disclosed in the Company’s Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including its Chief Executive Officer and Principal Finance and Accounting Officer, as appropriate, to allow timely decisions regarding required disclosures. In designing and evaluating the disclosure controls and procedures, the Company’s management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives and the Company’s management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. We also established a disclosure committee which consists of certain members of the Company's senior management.
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After the formation of our disclosure committee and within the 90 days prior to the date of filing of this report, the disclosure committee, under the supervision and with the participation of the Company’s management, including the Company’s Chief Executive Officer and Principal Finance and Accounting Officer, carried out an evaluation of the effectiveness of the design and operation of the Company’s disclosure controls and procedures. Based upon their evaluation and subject to the foregoing, the Chief Executive Officer and Principal Finance and Accounting Officer concluded that the Company’s disclosure controls and procedures were effective in ensuring that material information relating to the Company is made known to the Chief Executive Officer and Principal Finance and Accounting Officer by others within the Company during the period in which this report was being prepared.
There have been no significant changes in the Company’s internal controls or in other factors that could significantly affect these controls subsequent to the date the Company completed its evaluation.
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PART II - OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
(a) | Exhibits |
99.1 | Certification of Paul J. Maddon, M.D., Ph.D., Chairman and Chief Executive Officer of the Registrant pursuant to 18 U.S.C. Section 1350 | ||
99.2 | Certification of Robert A. McKinney, Vice President, Finance and Operations (Principal Finance and Accounting Officer) of the Registrant pursuant to 18 U.S.C. Section 1350 |
(b) | During the quarter ending September 30, 2002, the Registrant did not file any Current Reports on Form 8-K. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
PROGENICS PHARMACEUTICALS, INC. | ||
Date: November 14, 2002 | by /s/ ROBERT A. McKINNEY | |
Robert A. McKinney | ||
Vice President | ||
(Duly authorized officer of the Registrant and Principal Financial and Accounting Officer) |
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CERTIFICATION
PURSUANT
TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
I, Paul J. Maddon, M.D., Ph.D., certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Progenics Pharmaceuticals, Inc.; | |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; | |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; | |
4. | The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: | |
a) | designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, if any, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |
b) | evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |
c) | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; | |
5. | The registrant's other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): | |
a) | all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and | |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal controls; and | |
6. | The registrants other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
/s/ PAUL J. MADDON | |
Date: November 14, 2002 | Paul J. Maddon, M.D., Ph.D. |
Chairman & Chief Executive Officer |
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CERTIFICATION
PURSUANT
TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
I, Robert A. McKinney, certify that:
1. | I have reviewed this quarterly report on Form 10-Q of Progenics Pharmaceuticals, Inc.; | |
2. | Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; | |
3. | Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; | |
4. | The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have: | |
a) | designed such disclosure controls and procedures to ensure that material information relating to the registrant, including its consolidated subsidiaries, if any, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; | |
b) | evaluated the effectiveness of the registrant's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and | |
c) | presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; | |
5. | The registrants other certifying officer and I have disclosed, based on our most recent evaluation, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent function): | |
a) | all significant deficiencies in the design or operation of internal controls which could adversely affect the registrant's ability to record, process, summarize and report financial data and have identified for the registrant's auditors any material weaknesses in internal controls; and | |
b) | any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and | |
6. | The registrants other certifying officer and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. |
/s/ ROBERT A. McKINNEY | |
Date: November 14, 2002 | Robert A. McKinney |
Vice President, Finance & Administration |
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EXHIBIT INDEX
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