<PAGE>
SECURITIES AND EXCHANGE COMMISSION Conformed
Washington, D.C. 20549 Copy
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the quarterly period ended March 31, 1998
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OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the transition period from to
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Commission file number 333-02015
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CYTOGEN Corporation
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(Exact name of Registrant as specified in its charter)
Delaware 22-2322400
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(State or Other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification Number)
600 College Road East, CN 5308, Princeton, NJ 08540-5308
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(Address of Principal Executive Offices and Zip Code)
Registrant's telephone number, including area code (609) 987-8200
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days: Yes X No .
--- ---
Indicate the number of shares outstanding of each of the issuer's
classes of common stock, as of the latest practicable date:
Class Outstanding at April 30, 1998
---------------------------- -----------------------------
Common Stock, $.01 par value 54,866,143
<PAGE>
PART I - FINANCIAL INFORMATION
- ------------------------------
Item I: Consolidated Financial Statements
CYTOGEN CORPORATION AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(All amounts in thousands, except share data)
(Unaudited)
<TABLE>
<CAPTION>
March 31, December 31,
1998 1997
ASSETS: --------- ------------
<S> <C> <C>
Current Assets:
Cash and cash equivalents $ 2,487 $ 7,401
Accounts receivable, net 5,794 4,064
Inventories 255 443
Other current assets 317 258
---------- ----------
Total current assets 8,853 12,166
---------- ----------
Property and Equipment:
Leasehold improvements 10,128 10,126
Equipment and furniture 7,761 7,696
---------- ----------
17,889 17,822
Less- Accumulated depreciation and amortization (14,254) (13,910)
---------- ----------
Net property and equipment 3,635 3,912
---------- ----------
Investment in Subsidiary 9,250 10,343
Other Assets 1,134 1,134
---------- ----------
$ 22,872 $ 27,555
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current Liabilities:
Accounts payable and accrued liabilities $ 5,240 $ 5,662
Current portion of long-term liabilities 1,793 1,739
---------- ----------
Total current liabilities 7,033 7,401
---------- ----------
Long-Term Liabilities 10,185 10,171
---------- ----------
Stockholders' Equity:
Preferred stock, $.01 par value, 5,400,000 shares authorized -
Series A Convertible and Exchangeable Preferred Stock, $.01 par value,
1,000 shares authorized, 0 and 1,000 shares issued and outstanding in
1998 and 1997, respectively - -
Series B Convertible Preferred Stock, $.01 par value,
750 shares authorized, 450 and 750 shares issued and outstanding
in 1998 and 1997, respectively (liquidation value of $4,500 and
$7,500 in 1998 and 1997, respectively) - -
Common stock, $.01 par value, 89,600,000 shares authorized,
53,359,000 and 51,170,000 shares issued and outstanding
in 1998 and 1997, respectively 534 512
Additional paid-in capital 298,280 298,212
Accumulated deficit (293,160) (288,741)
---------- ----------
Total stockholders' equity 5,654 9,983
---------- ----------
$ 22,872 $ 27,555
========== ==========
</TABLE>
The accompanying notes are an integral part of these statements.
2
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CYTOGEN CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(All amounts in thousands, except per share data)
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended March 31,
1998 1997
----------------------------
<S> <C>
Revenues:
Product Related:
Product Sales $ 1,833 $ 870
Royalty 1,631 -
--------- ---------
3,464 870
License and Contract 667 2,984
--------- ---------
Total Revenues 4,131 3,854
--------- ---------
Operating Expenses:
Cost of Product Related and Contract Manufacturing Revenues 853 232
Research and Development 4,127 8,593
Equity Loss in Subsidiary 1,020 288
Selling and Marketing 1,051 1,126
General and Administrative 1,405 1,530
--------- ---------
Total Operating Expenses 8,456 11,769
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Operating Loss (4,325) (7,915)
Interest Income 206 264
Interest Expense (218) (73)
--------- ---------
Net Loss (4,337) (7,724)
Dividends on Series B Preferred Stock (82) -
--------- ---------
Net Loss to Common Stockholders $ (4,419) $ (7,724)
========= =========
Basic and Diluted Net Loss per Common Share $ (0.08) $ (0.15)
========= =========
Basic and Diluted Weighted Average
Common Shares Outstanding 52,620 51,088
========= =========
</TABLE>
The accompanying notes are an integral part of these statements. <PAGE>
3
<PAGE>
CYTOGEN CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(All amounts in thousands)
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended March 31,
1998 1997
----------------------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net Loss $ (4,337) $ (7,724)
Adjustments to Reconcile Net Loss to Cash Used for --------- ---------
Operating Activities:
Depreciation and Amortization 344 377
Imputed Interest 40 65
Stock Grants 11 14
Equity Loss in Subsidiary 1,020 288
Changes in Assets and Liabilities:
Accounts receivable, net (1,730) (2,787)
Inventories 188 21
Other assets 14 (144)
Accounts payable and accrued liabilities (445) 2,403
--------- ---------
Total adjustments (558) 237
--------- ---------
Net cash used for operating activities (4,895) (7,487)
--------- ---------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of Property and Equipment (8) (174)
Purchases of Short-Term Investments - (8,019)
--------- ---------
Net cash used for investing activities (8) (8,193)
--------- ---------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from Issuance of Common Stock 17 6
Principal Payment of Capital Lease Obligations (28) (26)
--------- ---------
Net cash used for financing activities (11) (20)
--------- ---------
Net Decrease in Cash and Cash Equivalents (4,914) (15,700)
Cash and Cash Equivalents, Beginning of Period 7,401 20,296
--------- ---------
Cash and Cash Equivalents, End of Period $ 2,487 $ 4,596
========= =========
</TABLE>
The accompanying notes are an integral part of these statements.
4
<PAGE>
CYTOGEN CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
The Company
CYTOGEN Corporation ("CYTOGEN" or the "Company") is a
biopharmaceutical company engaged in the development, commercialization
and marketing of products to improve diagnosis and treatment of
cancer and other disease. In March 1997, CYTOGEN received approval
from the U.S. Food and Drug Administration ("FDA") to market Quadramet,
CYTOGEN's product for the relief of pain due to cancers that have spread
to the skeleton and that can be visualized on a bone scan. In October 1996,
CYTOGEN received marketing approval from FDA for the ProstaScint imaging
agent, CYTOGEN's prostate cancer diagnostic imaging product. In December
1992, FDA approved OncoScint CR/OV imaging agent, CYTOGEN's colorectal and
ovarian cancer specific diagnostic imaging product, for single administration
per patient. In November 1995, FDA approved an expanded indication allowing
for repeat administration of OncoScint CR/OV. All three products are currently
available in the market place. Operations of the Company are subject to
certain risks and uncertainties including, but not limited to uncertainties
related to access to capital, product market acceptance, product efficacy
and clinical trials, technological uncertainty, uncertainties of future
profitability, dependence on collaborative relationships and key personnel.
The Company has incurred losses since its inception and expects to incur
significant operating losses in the future. There can be no assurance that
the Company will ever be able to commercialize successfully its products or
that profitability will ever be achieved.
The accompanying financial statements have been prepared on
a going concern basis, which contemplates the realization of assets
and satisfaction of liabilities in the normal course of business.
Management believes the Company's existing capital resources and
other available sources of financing will be adequate to fund the
Company's operations into 1999. Additional financings are
available under certain conditions through the sale of Preferred
Stock under an existing financing commitment. Currently, the
Company does not meet all of the conditions to draw down additional
funds. Based on the Company's historical ability to raise capital
and current market conditions, the Company believes other financing
alternatives (including arrangements with collaborative partners)
are available. There can be no assurance that the existing
Preferred Stock financing commitment or other financial alternatives
will be available when needed or at terms commercially
acceptable to the Company. If necessary, management believes it
has the ability to reduce its operating expenses so the Company
will have adequate cash flow to sustain operations into 1999 and
beyond. If an operating expense reduction plan was implemented, it
would require the Company to delay, scale back or eliminate
significant aspects of the Company's operations.
5
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CYTOGEN CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Cont'd)
Basis of Consolidation
The consolidated financial statements include the accounts of
CYTOGEN and its wholly- owned subsidiaries, AxCell Biosciences
Corporation ("AxCell") and Cellcor, Inc. ("Cellcor"). The
financial statements also include the losses of Targon Corporation
("Targon") which are accounted for on the equity method (see
Investment in Subsidiary). Intercompany balances and transactions
have been eliminated in consolidation.
Basis of Presentation
The consolidated financial statements of CYTOGEN Corporation
are unaudited and include all adjustments which, in the opinion of
management, are necessary to present fairly the financial condition
and results of operations as of and for the periods set forth in
the Consolidated Balance Sheets, Consolidated Statements of
Operations and Consolidated Statements of Cash Flows. All such
accounting adjustments are of a normal, recurring nature. The
consolidated financial statements do not include all of the
information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting
principles and should be read in conjunction with the consolidated
financial statements and notes thereto included in the
Company's Annual Report on Form 10-K/A, filed with the Securities
and Exchange Commission, which includes financial statements as of
and for the year ended December 31, 1997. The results of the
Company's operations for any interim period are not necessarily
indicative of the results of the Company's operations for any other
interim period or for a full year.
Cash and Cash Equivalents
Cash and cash equivalents include cash on hand, cash in banks
and all highly-liquid investments with a maturity of three months
or less at the time of purchase.
Investment in Subsidiary (Targon Corporation)
As discussed in Note 3, on March 31, 1998, the Company's
ownership interest in Targon was reduced from 99.75% to 49.875%.
As a result, the Company began accounting for its investment in
Targon using the equity method. In addition, the Company retroactively
adopted Emerging Issues Task Force (EITF) 96-16. Under the
equity method, the Company recognizes 100% of Targon's losses in
its consolidated statement of operations as "Equity Loss in
Subsidiary" with a corresponding reduction in the carrying amount
of its investment. The use of the equity method had no effect on
the Company's previously reported net loss, stockholders' equity or
cash flows. Included in "Investment in Subsidiary" is a $10
million note receivable from Targon which bears interest at the six
month LIBOR plus 1%, and is adjusted on a semi-annual basis and is
due in full in July 2000. This amount was reduced by the equity
losses discussed above. Included in long-term liabilities is a $10
million loan payable to Elan Corporation, plc ("Elan"), the proceed
6
<PAGE>
CYTOGEN CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Cont'd)
of which was used to fund Targon. This loan is payable and bears
interest at the same terms as described above. CYTOGEN and Elan
are currently negotiating to divide Targon's assets and liabilities
between the parties.
As a result of the restatement, approximately $392,000 of
research and development expense recorded in the first quarter of
1997 statement of operations was reclassified to "Equity Loss in
Subsidiary". The primary effect on the December 31, 1997 balance
sheet was the reclassification of Restricted Cash to "Investment
in Subsidiary". All other changes were immaterial.
Net Loss Per Share
Basic net loss per common share is based upon the weighted
average common shares outstanding during each period. Diluted net
loss per common share is the same as basic net loss per common
share, as the inclusion of common stock equivalents would be
antidilutive.
Reclassifications
Certain reclassifications have been reflected in the 1997
financial statements to conform with the 1998 presentation.
New Accounting Pronouncements
In June 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standards (SFAS) No. 130, which
establishes standards for reporting and disclosure of comprehensive
income. SFAS No. 130 is effective for interim and annual periods
beginning after December 15, 1997. SFAS No. 130 requires additional
disclosures in the Company's consolidated financial statements, but
does not have any impact on the Company's financial position or
consolidated results of operations. The Company has reviewed SFAS
No. 130 and determined that for the three months ended March 31, 1998
and 1997, no items meeting the definition of comprehensive income
as specified in SFAS No. 130 existed in the financial statements.
As a result, no disclosure is necessary to comply with SFAS No. 130.
2. QUADRAMET RELATED REVENUES/EXPENSES:
In March 1997, the Company received marketing approval from
FDA for Quadramet. As a result of the approval CYTOGEN recorded a
milestone payment of $2.0 million from The DuPont Merck Pharmaceutical
Company ("DuPont Merck"), for manufacturing and marketing rights to
Quadramet, and also recorded a $4.0 million milestone payment to
The Dow Chemical Company ("Dow") for the exclusive license to Quadramet.
Since the product launch in the second quarter of 1997, CYTOGEN has
7
<PAGE>
CYTOGEN CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Cont'd)
earned royalty revenues from DuPont Merck and paid royalty expenses
to Dow. Royalty revenues and expenses are based on a percentage of
sales of Quadramet or guaranteed contractual minimum royalty payments,
whichever is greater. For the three months ended March 31, 1998,
CYTOGEN recorded $1.6 million in royalty revenues and $125,000 in
royalty expenses.
3. TARGON CORPORATION:
Targon was established in September 1996 pursuant to
agreements between CYTOGEN and Elan and was a majority-owned
(99.75%) subsidiary of CYTOGEN. On March 31, 1998, Elan exchanged
its shares of the Company's Series A Convertible Preferred Stock
("Series A") for 50% of CYTOGEN's interest in Targon. Elan is
entitled through March 31, 2003 to exercise a warrant to purchase
up to 1 million shares of CYTOGEN common stock, at an exercise
price of $9.00 per share. As a result of the exchange, all rights
to conversion into CYTOGEN's common stock were terminated.
4. CONVERSION OF CYTOGEN'S SERIES B PREFERRED STOCK:
During the first quarter of 1998, an aggregate of $3 million
face amount of the Company's Series B Preferred Stock ("Series B")
issued in December 1997 was converted into common stock resulting
in the issuance of 2,157,760 shares of CYTOGEN common stock for
both the conversion and accrued dividends.
8
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations
From time to time, as used herein, the term "Company" may
include CYTOGEN and its wholly owned subsidiaries AxCell and
Cellcor, taken as a whole, where appropriate.
Results of Operations
Background. To date, the Company's revenues have resulted
primarily from (i) sales of ProstaScint and OncoScint, (ii)
royalties earned on Quadramet sales by DuPont Merck , (iii) the
recovery of costs related to the treatment of patients receiving
autolymphocyte therapy ("ALT") for metastatic renal cell carcinoma
("mRCC") under a Treatment Investigational New Drug program and
compassionate protocol which permits patients who do not qualify
for or have completed treatment under an ongoing study approved by
FDA to receive treatment, (iv) payments received from contract
manufacturing and research services pursuant to agreements, (v)
fees generated from the licensing of its technology and marketing
rights to its products, and (vi) milestone payments received when
events stipulated in the collaborative agreements with third
parties have been achieved.
In 1997, CYTOGEN launched two new products, Quadramet and
ProstaScint, into the market place.
Quadramet is marketed by DuPont Merck. During the first year
of launch, Quadramet was marketed principally to the nuclear
medicine community, which administers the treatment to patients.
However, the treatment is more typically prescribed by the
caregiving physicians, including oncologists and urologists. The
Company believes that successful commercialization of Quadramet
will depend upon marketing to these referring physicians and that
efforts to reach these groups will require additional training and
commitment of resources by the Company's marketing partner and
additional marketing partners with sales forces experienced in
marketing products for pain management directly to the referring
physicians. The Company plans, along with DuPont Merck, to expand
the marketing program to address these issues, although no
assurances can be given as to the Company's ability to implement
this strategy successfully or as to the time frame within which
this strategy can be accomplished.
C.R. Bard, Inc. ("Bard") markets ProstaScint to urologists
while CYTOGEN markets ProstaScint to the medical imaging community
and oncologists through its PIE Program (described below). Both
companies market ProstaScint to managed care organizations
("MCOs"). CYTOGEN's focus is to increase the MCOs' awareness of
and to obtain coverage for ProstaScint in addition to incorporating
ProstaScint into the MCOs' patient practice guidelines. CYTOGEN's
costs of its efforts related to marketing to MCOs are immaterial
and primarily attributable to its own marketing personnel.
In connection with the launch of ProstaScint, CYTOGEN has
developed its PIE (Partners in Excellence) accreditation program
by establishing a network of qualified nuclear medicine sites and
physicians. Each site is trained and certified in acquiring,
processing and interpreting the antibody-derived images. As of
April 28, 1998, there were 192 PIE sites in operation. ProstaScint
9
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
is available for use only at qualified PIE sites, thus providing
quality control and support. By early 1999, the Company is
required by its co-marketing agreement with Bard to have at least
220 PIE sites established. The Company expects that it will be
able to comply with this requirement. Currently, a backlog exists
with respect to facilities requesting certification as PIE sites
because the number of nuclear imaging centers requesting certification
exceeds existing resources which the Company has available to
establish new PIE sites. The Company believes that some indeterminable
level of sales may be lost as a result of the backlog, however, the
Company also believes that the maintenance of quality of the sites is
essential to the success of the product. At the present time, the
Company incurs the expense of qualification of each site.
On March 25, 1998, the Company announced that, based on an
ongoing review and prioritization of its business opportunities, it
had delayed indefinitely submission of a Biologics License
Application for its ALT for mRCC. CYTOGEN is currently seeking
potential partners for future funding and development of ALT. The
Company will also consider the sale of Cellcor to another
healthcare company that has an interest and the resources to
actively pursue FDA approval of ALT for mRCC and other indications.
The Company anticipates that this action will reduce operating
expenses significantly and permit allocation of additional
resources to other Company priorities. ALT is a proprietary
cellular therapy which has been under development by Cellcor for
the treatment of mRCC, a life threatening kidney cancer, for which
adequate therapies do not exist. Cellcor completed pivotal Phase
III clinical trials of ALT in mRCC patients in January 1997, and
the Company believes the results of the trials are favorable.
On March 31, 1998, Elan exchanged its shares of the Company's
Series A Preferred Stock and thereby acquired 50% of CYTOGEN's
99.75% ownership of Targon, as contemplated by the terms of such
Series A (see Note 3 to the Consolidated Financial Statements).
CYTOGEN and Elan are currently negotiating to divide Targon assets
and liabilities between the parties. The Company believes that
Elan's acquisition of a 49.875% ownership interest of Targon will
not have a material adverse effect on the Company's financial
position, results of operations or cash flows.
Revenues. Total revenues for the three months ended March
31, 1998 and 1997 were $4.1 million and $3.9 million, respectively.
The product related revenues, which includes product sales and
royalty revenues on Quadramet, accounted for 84% of total revenues
in 1998 versus 23% from the same period of the prior year. License
and contract revenues accounted for the remainder of revenues with
16% and 77% of the total revenues recorded in the three months
ended March 31, 1998 and 1997, respectively.
Product related revenues for the three months ended March 31,
1998 and 1997, were $3.5 million and $870,000, respectively.
ProstaScint accounted for 44% and 69% of product related revenues
in the first quarters of 1998 and 1997, respectively, while
OncoScint accounted for 8% and 28% of product related revenues in
1998 and 1997, respectively. The product launch of ProstaScint was
10
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
during February 1997. Sales from ProstaScint were $1.5 million in
the first quarter of 1998 compared to $603,000 in the first quarter
of 1997, while sales from OncoScint were $262,000 in the first
quarter of 1998 versus $244,000 in the same period of 1997.
Revenues from ALT treatments for mRCC were $34,000 in 1998 compared
to $23,000 recorded in the comparable period of 1997. Royalty
revenues accounted for the balance of the first quarter of 1998
product related revenues representing 47% or $1.6 million, of total
product related revenues. All royalty revenues are attributable to
Quadramet, which was launched by DuPont Merck at the end of May
1997. To date, royalties based on a percentage of sales, have been
substantially less than the guaranteed contractual minimum
royalties.
License and contract revenues for the three months ended
March 31, 1998 and 1997 were $667,000 and $3.0 million, respectively.
The first quarter 1998 license and contract revenues included $485,000
in contract manufacturing revenues from six customers, and $75,000 in
milestone payment from Faulding (Canada), Inc. ("Faulding"). The 1997
first quarter revenues included a $2.0 million milestone payment from
DuPont Merck, $365,000 and $317,000 in research revenues from DuPont
Merck for continued clinical development of Quadramet and from Elan,
respectively, and $153,000 in contract manufacturing revenues from six
customers. License and contract revenues have fluctuated in the past
and may fluctuate in the future.
Operating Expenses. The current year operating expenses
reflect the Company's continued efforts in developing and marketing
of products. For the three months ended March 31, 1998 operating
expenses were $8.5 million compared to $11.8 million recorded in
the same period of 1997. The decrease from the prior year period
is due to a one-time $4.0 million milestone payment to Dow recorded
in the first quarter of 1997 upon the approval of Quadramet by FDA
partially offset in 1998 by increased losses from Targon, royalty
expenses for Quadramet and costs associated with the increased
product related and contract manufacturing revenues in 1998.
Cost of product related and contract manufacturing revenues
for the three months ended March 31, 1998 were $853,000 compared to
$232,000 recorded in the same period of the prior year. The
increase from the prior period is due primarily to increased
manufacturing costs associated with increased revenues in 1998, and
royalty expenses related to Quadramet (see Note 2 to the Consolidated
Financial Statements).
Research and development expenses for the three months ended
March 31, 1998 were $4.1 million compared to $8.6 million
recorded in the same period of 1997. These expenses principally
reflect product development efforts and support of clinical trials.
The decrease from the prior year period is due to the aforementioned
$4.0 million milestone payment to Dow in the first quarter of 1997
combined with the various savings from the Company's product development
efforts in 1998.
Equity loss in subsidiary (Targon) for the three months ended
March 31, 1998 and 1997 was $1.0 million and $288,000, respectively.
Targon's expenses reflected product development and clinical trials
programs. During the first quarter of 1998, Targon's program costs
and commitments had increased due to the financial support of the
Duke University research agreement, the addition of costs related to
11
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
new products acquired by Targon and the acceleration of clinical programs.
On March 31, 1998, Elan exchanged its shares of the Company's Series A
Preferred Stock and thereby acquired 50% of CYTOGEN's 99.75% ownership of
Targon (see Note 3 to the Consolidated Financial Statements). CYTOGEN
and Elan are currently negotiating to divide Targon assets and liabilities
between the parties.
Selling and marketing expenses were $1.1 million for each of
the three month periods ended March 31, 1998 and 1997. The 1998
expenses reflected the marketing efforts to increase ProstaScint
sales and expenses to establish and maintain PIE sites. The 1997
expenses included expenses associated with ProstaScint launch and
PIE program.
General and administrative expenses for the three months
ended March 31, 1998 were $1.4 million which is slightly lower than
the $1.5 million recorded in the comparable period of 1997.
Interest Income/Expense. Interest income for the three
months ended March 31, 1998 was $206,000 compared to $264,000
realized in the same period of the prior year. The decrease from
the prior year period is due to lower cash and short term investment
balances for the periods. This is partially offset by the $169,000
interest income realized from the $10.0 million note due to Cytogen
from Targon during the three months ended March 31, 1998.
Interest expense for the three months ended March 31, 1998
was $218,000 compared to $73,000 recorded in the same period of
1997. The increase from the prior year period is due to the
$169,000 interest expense associated with the $10.0 million note
due to Elan for the three months ended March 31, 1998.
Net Loss. Net loss to common stockholders for the three
months ended March 31, 1998 was $4.4 million compared to a net
loss of $7.7 million incurred in the same period of 1997. The loss
per common share was $0.08 on 52.6 million average common shares
outstanding compared to $0.15 on 51.1 million average common shares
outstanding for the same period in 1997. The 1998 net loss
included $82,000 of accrued dividends on the Series B Preferred
Stock.
Liquidity and Capital Resources
The Company's cash and cash equivalents were $2.5 million as
of March 31, 1998, compared to $7.4 million as of December 31,
1997. The cash used for operating activities for the three months
ended March 31, 1998 was $4.9 million compared to $7.5 million in
the same period of 1997. The decrease in cash usage for operating
activities from the prior year period was primarily due to the
receipts of revenues generated from Quadramet and ProstaScint.
Historically, the Company's primary sources of cash have been
proceeds from the issuance and sale of its stock through public
offerings and private placements, product related revenues,
revenues from contract manufacturing and research services, fees
paid under its license agreements and interest earned on its note
receivable from Targon and its cash and short term investments.
12
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
In 1997, the Company completed $7.5 million of a $20.0
million financing commitment with a group of private investors,
whereby the Company, on satisfaction of certain conditions, has the
option to draw down the balance of the commitment or $12.5 million
over the course of 1998. The financing is in the form of a 6%
convertible preferred stock which is convertible by the investors
at any time and convertible or redeemable by the Company, at its
option, in three years. The dividend is payable in cash or common
stock of CYTOGEN at the Company's option at the earlier of the
conversion date or when and as declared by the Board of Directors
(see Note 4 to the Consolidated Financial Statements). Currently,
the Company does not meet all of the conditions to draw down the
additional funds.
Quadramet. Quadramet was launched by DuPont Merck in June
1997. An agreement between CYTOGEN and DuPont Merck provides for
CYTOGEN to receive from DuPont Merck royalty revenues based on a
percentage of sales of Quadramet or guaranteed contractual minimum
royalty payments, whichever is greater, and additional payments
upon achievement of certain other milestone payments. For the
three months ended March 31, 1998, CYTOGEN recorded $1.6 million
in royalty revenues for Quadramet. As of March 31, 1998,
approximately 74% of the Company's accounts receivable balance was
due from DuPont Merck.
CYTOGEN acquired an exclusive license in the U.S., Canada and
Latin America from Dow for Quadramet. The agreement requires the
Company to pay Dow royalties based on a percentage of net sales
of Quadramet, or guaranteed contractual minimum payments,
whichever is greater, and future payments upon achievement of
certain milestones. Minimum royalties due Dow for 1998 are
$500,000. For the three months ended March 31, 1998, the Company
recorded $125,000 in royalty expenses for Quadramet.
ProstaScint. ProstaScint was officially launched in February
1997. Product related revenues now include sales of ProstaScint.
Significant cash will be required to support the Company's
marketing program and expansion and maintenance of the PIE program.
In 1996, CYTOGEN entered into an agreement with Bard (the
"Co-Promotion Agreement") to market and promote ProstaScint,
pursuant to which Bard will make payments upon the occurrence of
certain milestones, which include expansion of co-marketing rights
in selected countries outside the U.S. During the term of the
Co-Promotion Agreement, Bard will receive performance-based compensation
for its services. For the three months ended March 31, 1998 and 1997,
the Company recorded $154,000 and $75,000, respectively, for Bard
commission.
OncoScint CR/OV. To date, sales of OncoScint CR/OV have not
been material and are not expected to become a significant source
of cash flow in the future. In 1994, the Company reacquired all
U.S. marketing rights to OncoScint from Knoll Pharmaceuticals
Company ("Knoll") and is required to pay Knoll $1.7 million in
1998. The Company will fund this payment from product related
revenues and other sources.
13
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
CYTOGEN entered into agreements with Faulding and CIS
biointernational ("CISbio"), respectively, to market and distribute
OncoScint CR/OV outside the U.S. Faulding and CISbio will be
required to make payments for the purchase of products and
royalties on net sales, if any.
In July 1997, the Company obtained a $10.0 million loan from
Elan. The loan is payable in full at the end of year three and
bears interest which is payable quarterly at the six month LIBOR
rate plus 1% and is adjusted on a semi-annual basis. The funds
were used by CYTOGEN to provide funding to Targon. For the three
months ended March 31, 1988, the Company recorded $169,000 of
interest expense in connection with this note.
The Company's capital and operating requirements may change
depending upon several factors, including: (i) the success of the
Company and its strategic partners in manufacturing, marketing and
commercialization of its products; (ii) the amount of resources
which the Company devotes to clinical evaluations and the expansion
of marketing and sales capabilities; (iii) results of preclinical
testing, clinical trials and research and development activities;
and (iv) competitive and technological developments.
The Company's financial objectives are to meet its capital
and operating requirements through revenues from existing products,
contract manufacturing, license and research contracts, and from
control of spending. To achieve its strategic objectives, the
Company may enter into research and development partnerships and
acquire, in-license and develop other technologies, products or
services. Certain of these strategies may require payments by the
Company in either cash or stock in addition to the costs associated
with developing and marketing a product or technology. The Company
currently has no commitments or specific plans for acquisitions or
strategic alliances. However, the Company believes that, if
successful, such strategies may increase long term revenues. There
can be no assurance as to the success of such strategies or that
resulting funds will be sufficient to meet cash requirements until
product and royalty revenues are sufficient to cover operating
expenses. To fund these strategic and operating activities, the
Company may sell equity and debt securities as market conditions
permit or enter into credit facilities.
The Company has incurred negative cash flows from operations
since its inception, and has expended, and expects to continue to
expend in the future, substantial funds to complete its planned
product development efforts, including acquisition of products and
complementary technologies, research and development, clinical
studies and regulatory activities, and to further expand its
marketing, sales, manufacturing and distribution activities. The
Company expects that its existing capital resources and other
available sources of financing will be adequate to fund the
Company's operations into 1999. No assurance can be given that the
Company will not consume a significant amount of its available
resources before that time. In addition, the Company expects that
it will have additional requirements for debt or equity capital,
irrespective of whether and when it reaches profitability, for
further development of products, product and technology acquisition
costs, and working capital. The Company's future capital requirements
and the adequacy of available funds will depend on numerous factors,
including the successful commercialization of its products, the
14
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
costs associated with the acquisition of complementary products and
technologies, progress in its product development efforts, the
magnitude and scope of such efforts, progress with preclinical studies
and clinical trials, progress with regulatory affairs activities, the
cost of filing, prosecuting, defending and enforcing patent claims and
other intellectual property rights, competing technological and market
developments, and the expansion of strategic alliances for the sales,
marketing, manufacturing and distribution of its products. To the
extent that funds generated from the Company's product-related and
license and contract revenues, together with its existing capital
resources are insufficient to meet current or planned operating
requirements, the Company will be required to obtain additional funds
through equity or debt financing, strategic alliances with corporate
partners and others, or through other sources. The Company has a commitment
pursuant to which it may issue up to $12.5 million in additional
series of convertible preferred stock, under certain conditions.
Currently, the Company does not meet all of the conditions to draw
down the additional funds. Based on the Company's historical
ability to raise capital and current market conditions, the Company
believes other financing alternatives are available. There can be
no assurance that the financing commitment described above or other
financial alternatives will be available when needed or at terms
commercially acceptable to the Company. If adequate funds are not
available, the Company may be required to delay, scale back or
eliminate certain aspects of its operations or attempt to obtain
funds through arrangements with collaborative partners or others
that may require the Company to relinquish rights to certain of its
technologies, product candidates, products or potential markets.
If adequate funds are not available, the Company's business,
financial condition and results of operations will be materially
and adversely affected. However, the Company believes that it has
the ability to reduce its operating expenses so that it will have
adequate cash flow to sustain operations into 1999 and beyond.
==========================
Cautionary Statement
The foregoing discussion contains historical information as
well as forward looking statements that involve a number of risks
and uncertainties. In addition to the risks discussed above, among
other factors that could cause actual results to differ materially
from expected results are the following: (i) the Company's ability
to continue as a going concern if the Company is unable to raise
sufficient funds or generate sufficient cash flows from operations
to cover the cost of its operations; (ii) the Company's ability to
access the capital markets in the near term and in the future for
continued funding of existing projects and for the pursuit of new
projects; (iii) the timing and results of clinical studies; (iv)
market acceptance of the Company's products, including programs
designed to facilitate use of the products, such as the PIE
Program; (v) the decision by the majority of public and private
insurance carriers on whether to reimburse patients for the
Company's products; (vi) the profitability of its products; (vii)
the ability to attract, and the ultimate success of strategic
partnering arrangements, collaborations, and acquisition candidates;
(viii) the ability to attract additional contract manufacturing
customers; (ix) the ability of the Company and its partners
to identify new products as a result of those collaborations that
are capable of achieving FDA approval, that are cost-effective
alternatives to existing products and that are ultimately accepted
15
<PAGE>
Item 2 - Management's Discussion and Analysis of Financial Condition
and Results of Operations (Cont'd)
by the key users of the product; (x) the success of the Company's
marketing partners in obtaining marketing approvals in Canada and
in European countries, in achieving milestones and achieving sales
of products resulting in royalties.
16
<PAGE>
PART II - OTHER INFORMATION
- ------- -----------------
Item 6 - Exhibits and Reports on Form 8-K
- ------
(a) Exhibits:
27 - Financial Data Schedule (Submitted to SEC only
in electronic format).
(b) Reports on Form 8-K:
On January 22, 1998, the Company filed a report on
Form 8-K reporting on "Item 5. Other Events" with
respect to a press release announcing management
changes.
17
<PAGE>
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.
CYTOGEN CORPORATION
Date May 15, 1998 By /s/ Jane M. Maida
---------------- ------------------------
Jane M. Maida
Chief Accounting Officer
18
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED BALANCE SHEETS AS OF MARCH 31, 1998 AND THE CONSOLIDATED STATEMENTS
OF OPERATIONS FOR THE THREE-MONTH PERIOD ENDED MARCH 31, 1998 AND IS QUALIFIED
IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-END> MAR-31-1998
<CASH> 2,487,000
<SECURITIES> 0
<RECEIVABLES> 6,370,000
<ALLOWANCES> (576,000)
<INVENTORY> 255,000
<CURRENT-ASSETS> 317,000
<PP&E> 17,889,000
<DEPRECIATION> (14,254,000)
<TOTAL-ASSETS> 22,872,000
<CURRENT-LIABILITIES> 7,033,000
<BONDS> 0
0
0
<COMMON> 534,000
<OTHER-SE> 5,120,000
<TOTAL-LIABILITY-AND-EQUITY> 22,872,000
<SALES> 1,833,000
<TOTAL-REVENUES> 4,131,000
<CGS> 434,000
<TOTAL-COSTS> 1,485,000
<OTHER-EXPENSES> 6,971,000
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 218,000
<INCOME-PRETAX> (4,419,000)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (4,419,000)
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