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, 1995
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from __________ to __________
Commission File Number: 0-11749
SCIOS NOVA INC.
(Exact Name of Registrant as Specified in Its Charter)
DELAWARE 95-3701481
(State or Other Jurisdiction of (IRS Employer
Incorporation or Organization) Identification No.)
2450 Bayshore Parkway, Mountain View, California 94043
(Address of Principal Executive Offices) (Zip Code)
Registrant's Telephone Number, Including Area Code: 415-966-1550
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 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 ______
The number of shares outstanding of Registrant's Common Stock, $.001 par value,
on September 30, 1995 was 36,005,895.
SCIOS NOVA INC.
AND SUBSIDIARIES
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
SCIOS NOVA INC.
AND SUBSIDIARIES
Consolidated Balance Sheets
(In thousands, except share data)
ASSETS
September 30, December 31,
1995 1994
(Unaudited)
Current assets:
Cash and cash equivalents $872 $29,674
Available-for-sale securities 25,522 22,441
Accounts receivable 1,899 3,529
Other receivables 6 70
Prepaid expenses 823 1,147
Total current assets 29,122 56,861
Available-for-sale securities, non-current 61,183 52,324
Investment in affiliates 3,496 --
Property and equipment, net 36,158 35,118
Other assets 2,079 1,793
TOTAL ASSETS $132,038 $146,096
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $1,876 $3,301
Other accrued liabilities 7,025 11,557
Deferred contract revenue 6,182 2,444
Current portion of long-term debt 652 617
Total current liabilities 15,735 17,919
Long-term debt 1,247 1,739
Stockholders' equity:
Preferred stock; $.001 par value; 20,000,000
shares authorized; issued and outstanding:
16,053 and 21,053, respectively -- --
Common stock; $.001 par value; 150,000,000
shares authorized; issued and outstanding:
36,005,895 and 35,283,200, respectively 36 35
Additional paid-in capital 399,155 391,745
Notes receivable (20) (27)
Unrealized gains (losses) on securities 378 (2,309)
Accumulated deficit (284,493) (263,006)
Total stockholders' equity 115,056 126,438
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $132,038 $146,096
See notes to consolidated financial statements.
2.
SCIOS NOVA INC.
AND SUBSIDIARIES
Consolidated Statements of Operations
(In thousands, except share data)
Three months ended Nine months ended
September 30, September 30,
1995 1994 1995 1994
(Unaudited) (Unaudited)
Revenues:
Product sales $8,289 $9,307 $29,846 $30,666
Co-promotion commissions 563 1,208 1,605 2,708
Research & development contract 548 1,631 3,393 5,905
9,400 12,146 34,844 39,279
Costs and expenses:
Cost of goods sold 5,144 5,825 18,236 19,369
Research and development 7,654 9,058 22,379 26,684
Marketing, general and
administration 4,725 3,564 13,648 11,805
Restructuring Charge --- 3,500 --- 3,500
Profit distribution to third
parties 844 1,064 3,410 3,528
18,367 23,011 57,673 64,886
Loss from operations (8,967) (10,865) (22,829) (25,607)
Other income:
Investment income 1,478 940 3,857 3,496
Other income (expense), net 112 (117) 182 (308)
1,590 823 4,039 3,188
Equity in net loss of affiliates (887) (371) (2,697) (679)
Minority interests -- -- -- 596
Net loss ($8,264) ($10,413) ($21,487) ($22,502)
Net loss per common share ($0.23) ($0.30) ($0.61) ($0.64)
Weighted average number of
common shares outstanding 36,005,126 35,257,140 35,469,524 35,199,502
See notes to consolidated financial statements.
3.
SCIOS NOVA INC.
AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(In thousands)
Nine months ended
September 30,
1995 1994
(Unaudited)
Cash flows from operating activities:
Net loss $(21,487) $(22,502)
Adjustments to reconcile net loss to net
cash used by operating activities:
Depreciation and amortization 2,791 3,478
Deferred contract revenue 3,738 1,752
Other 2,697 (176)
Changes in assets and liabilities:
Accounts receivable 1,694 (1,155)
Other assets 38 448
Accounts payable (1,425) (656)
Other accrued liabilities (2,577) 3,572
Net cash used by operating activities (14,531) (15,239)
Cash flows from investing activities:
Payments for property and equipment, net (5,076) (2,613)
Sales of marketable securities 127,676 122,929
Purchases of marketable securities (136,929) (118,351)
Net cash provided (used) by
investment activities (14,329) 1,965
Cash flows from financing activities:
Issuance of common stock and collection
of notes receivable from stockholders, net 515 261
Debt issuance and repayments (457) (461)
Net cash provided (used) by
financing activities 58 (200)
Net decrease in cash and cash equivalents (28,802) (13,474)
Cash and cash equivalents at beginning of period 29,674 13,587
Cash and cash equivalents at end of period $ 872 $ 113
Supplemental cashflow data:
Net unrealized securities gains (losses) $ 2,687 $ (1,740)
See notes to consolidated financial statements
4.
SCIOS NOVA INC.
AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(unaudited)
1. Basis of Presentation and Accounting Policies
The unaudited consolidated financial statements of Scios Nova Inc.
("Scios Nova" or the "Company") reflect, in the opinion of management, all
adjustments, consisting only of normal and recurring adjustments, necessary to
present fairly the Company's financial position at September 30, 1995 and the
Company's results of operations for the three- and nine- month periods ended
September 30, 1995 and 1994. Interim-period results are not necessarily
indicative of results of operations or cash flows for a full-year period.
These financial statements and the notes thereto should be read in
conjunction with the Company's annual report on Form 10-K for the year ended
December 31, 1994.
The year-end balance sheet data was derived from audited financial
statements, but does not include all disclosures required by generally
accepted accounting principles.
The Company has adopted Financial Accounting Standards Board ("FASB")
Statement of Financial Accounting Standards No. 115, "Accounting for Certain
Investments in Debt and Equity Securities". All marketable securities at
September 30, 1995 were deemed by management to be available for sale and
therefore are reported at fair value with net unrealized gains or losses
reported in stockholders' equity.
2. The Company's ownership in Guilford Pharmaceuticals Inc.
("Guilford") declined from 29% to 16% as a result of Guilford's secondary
public stock offering in August, 1995. Because two officers of the Company
serve on Guilford's Board of Directors, the Company is continuing to account
for its investment in Guilford under the equity method. As a result of the
stock offering, in accordance with Staff Accounting Bulletin 5:H, the Company
increased its recorded investment in Guilford by $2.3 million in the third
quarter of 1995.
3. On May 25, 1995, the Company was served with three complaints
filed in the U.S. District Court for the Northern District of California by
three stockholders. The actions were filed against the Company and Richard
Casey, its Chairman and Chief Executive Officer, on behalf of the individual
plaintiffs and on behalf of other purchasers of the Company's stock during the
period from October 6, 1993 to May 2, 1995. The complaints, which were
combined in August, 1995 into a consolidated complaint, allege violations of
federal securities laws, claiming that the defendants issued a series of false
and misleading statements, including filings with the Securities and Exchange
Commission, regarding the Company and clinical trials involving one of its
products, AURICULIN [registered trademark] anaritide. The complaints seek
unspecified compensatory and punitive damages, attorneys fees and costs.
Discovery has not yet commenced. The Company believes it has meritorious
defenses and intends to defend the lawsuits vigorously. The ultimate outcome
of this action cannot presently by determined. Accordingly, no provision for
any liability or loss that may result from adjudication or settlement thereof
has been made in the accompanying consolidated financial statements.
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
Operating Results
The net loss for the quarter ended September 30, 1995 was $8.3 million
compared to a net loss of $10.4 million in the corresponding quarter of 1994.
For the nine-month periods ended September 30, 1995 and 1994, the net losses
were $21.5 million and $22.5 million, respectively. The decrease in net loss
from the 1994 period was primarily due to reduced expenses which resulted from
the closure of the Company's Baltimore research and development facility in
1994. The lower expenses were partially offset by a $4.4 million decrease in
revenues and a $2.0 million increase in equity in net loss of affiliates
attributable to Guilford Pharmaceuticals ("Guilford").
Total revenues for the three months ended September 30, 1995 declined
to $9.4 million from $12.1 million in the corresponding period of 1994 due to
reductions in product sales, co-promotion commissions and contract revenues.
Product sales from psychiatric products under license from SmithKline Beecham
Corporation (the "SB Products") declined to $8.3 million from $9.3 million
for the three months ended September 30, 1995 and 1994, respectively. Gross
margins increased to 40% for the quarter ending September 30, 1995 from 39%
in the prior year period. The decrease in co-promotion commissions resulted
from a change in the rate of revenue recognition due to a lowering of the
Company's expectations for year-over-year sales growth of HALDOL [registered
trademark] Decanoate, a product co-promoted with Ortho-McNeil Pharmaceutical
("McNeil"). Contract revenues declined because of the timing of license
payments from Kaken Pharmaceuticals Co., Ltd. ("Kaken") related to the
Company's basic fibroblast growth factor (bFGF).
For the nine months ended September 30, 1995 and September 30, 1994,
total revenues were $34.8 million and $39.3 million, respectively. The year-to
- -year revenue decrease resulted from the third quarter declines in the items
noted above, and because of certain payments received in 1994; milestone
payments from Pfizer Inc and Kaken and a final payment from E. Merck. Product
sales for the nine months ended September 30, 1995 and 1994 were $29.8 million
and $30.7 million, respectively. Gross margins of 39% and 37% for the nine
months ended September 30, 1995 and 1994, respectively, improved year-over-
year because of a higher margin product mix. Despite the short-term
improvement, margins are expected to decline over time as a result of generic
drug competition.
For both the three- and nine-month periods, the decline in revenues
from 1994 to 1995 was offset by a reduction in costs and expenses. Total
costs and expenses for the three months ended September 30, 1995 were $18.4
million versus $23.0 million for the same period in 1994. Spending for
research and development declined to $7.7 million from $9.1 million while
expenses for marketing, general and administration increased to $4.7 million
from $3.6 million for the three-month periods ended September 30, 1995 and
1994, respectively. The overall decline resulted from the closure of the
Company's Baltimore, Maryland research and development facility in the fourth
quarter of 1994. The decreases in profit distribution to third parties and
cost of goods for the three months ended September 30, 1995 from the
comparable 1994 period were the result of lower SB Product sales. The
increase in marketing, general and administrative costs for the same periods
was the result of higher spending on sales activities.
Total costs and expenses for the nine-month period ended September 30,
1995 were $57.7 million versus $64.9 million for the same period in 1994.
Research and development spending declined to $22.4 million in 1995 from
$26.7 million in 1994 as a result of savings from the closure of the Baltimore
research and development facility and the change to the equity method of
accounting for Guilford. Marketing, general and administrative spending
increased to $13.6 million from $11.8 million for the nine-month periods ended
September 30, 1995 and 1994, respectively, primarily because of higher sales
and marketing spending.
Other income increased to $1.5 million in the quarter ended September
30, 1995 from $0.8 million in the comparable quarter of 1994. The increase
was principally due to lower royalty expenses in 1995 because of lower
contract revenue and a net gain on sales of securities in 1995 versus a net
loss for the same period in 1994. The equity in the net loss of affiliates of
$0.9 million in 1995 is the Company's proportional share of Guilford's losses.
The increase from $0.4 million in the corresponding 1994 period was due to
higher losses at Guilford.
For the nine-month periods ended September 30, 1995 and 1994, other
income was $4.0 million and $3.2 million, respectively. The increase is due
to higher rental income and lower royalty expenses in 1995 combined with
increased investment income versus the comparable period in 1994. The
increase in equity in net loss of affiliates to $2.7 million in 1995 from $0.7
million in 1994, and the reduction in minority interest over the same periods,
were the result of the change in accounting method for the Company's
investment in Guilford.
Scios Nova's operating results have fluctuated from period to period
and are expected to continue to fluctuate in the future as a result of, among
other things: the outcome and timing of clinical trials and the regulatory
approval process; the timing and composition of funding under the Company's
collaborative research and development agreements; the continuation or renewal
of existing collaborations by Scios Nova's partners; the level of sales of SB
Products, which face increasing price pressure from competitive generic drugs
and from government and private cost-control initiatives; and the level of
commissions resulting from the Company's 1993 co-promotion agreement with
McNeil for HALDOL [registered trademark] Decanoate, which may be affected by
increased competition from other products. In addition, because the Company
participates in a highly dynamic industry, the Company's common stock price
may also experience significant volatility as a result of industry
developments and ongoing changes in the healthcare environment, as well as
fluctuations resulting from third party assessments of the Company's progress
on its research, development and clinical projects.
Liquidity and Capital Resources
Combined cash, cash equivalents and marketable securities (both current
and non-current) totaled $87.6 million at September 30, 1995, a decrease of
$16.9 million from December 31, 1994. The decrease was principally
attributable to $14.5 million to fund operating activities and $5.1 million
for capital acquisitions, which was partially offset by $2.7 million of
unrealized gains on marketable securities resulting from a change in market
interest rates during the nine-month period. Capital spending of $5.1 million
included $3.1 million for the purchase of the Company's former Baltimore
research and development facility pursuant to an option contained in the
lease. The Company is currently seeking to lease-out and/or sell the
facility.
The $3.5 million increase in investment in affiliates reflects the
write-up of the Company's equity investment in Guilford as a result of
Guilford's 1994 and 1995 public stock offerings, reduced by the Company's
proportional share of Guilford's losses.
The $1.1 million increase in net property and equipment balances from
December 31, 1994 to September 30, 1995 was principally due to the purchase
of the Baltimore facility, offset in part by the sale and write-off of surplus
equipment and by on-going depreciation expense.
The decrease in accounts payable of $1.4 million during the nine-month
period ended September 30, 1995 was the result of payment of year-end 1994
accruals.
The decrease in other accrued liabilities of $4.5 million from December
31, 1994 to September 30, 1995 was the result of reductions in the Baltimore
restructuring reserve of $2.3 million and accrued expenses of $2.2 million.
Of the $2.3 million change in the restructuring reserve, severance and related
costs accounted for 31%, asset write-downs 45%, facility carrying costs 17%
and chemical disposal and other expenses 7%. The asset write-downs of $1.0
million were non-cash expenses.
The increase in deferred contract revenue of $3.7 million was
principally due to a payment from Kaken associated with achieving future
milestones in the commercialization of the Company's product FIBLAST
[registered trademark] trofermin (bFGF) in Japan.
The increase in additional paid-in capital of $7.4 million was the
result of the write-up of the Company's equity investment in Guilford,
incentive compensation stock payments and proceeds from the exercise of
employee stock options.
The unrealized gain on securities of $0.4 million at September 30, 1995
represents the difference between the cost and market value of the Company's
marketable securities on that date. The $2.7 million increase from December
31, 1994 to September 30, 1995 was the result of a reduction in market
interest rates which took place during the first nine months of the year.
The Company's cash resources of $87.6 million at September 30, 1995,
together with revenues from product sales, collaborative agreements and
interest income, will be used to fund current and new clinical trials for
proprietary products under development, to support continuing research and
development programs and for other general purposes. The Company believes its
cash resources will be sufficient to meet its operating and capital
requirements for at least the next two years.
The Company has experienced net operating losses since its inception
and expects to continue to incur losses for at least several more years. The
Company's ability to achieve and sustain profitability will depend upon a
number of factors, particularly the success and timeliness of its product
development, clinical trial, regulatory approval and product introduction
efforts. Other contributing factors will be the Company's success in
developing new revenue sources to support research and development programs
and its success in marketing and promoting the SB Products, HALDOL [registered
trademark] Decanoate and any other third-party products that may be in-
licensed by the Company.
The Company may need to seek additional funding to support future
operations, including the commercialization of products currently under
development. Potential funding sources include collaborative arrangements and
additional public or private financings, including additional equity
financings. There can be no assurances that such additional funding, if
required, can be obtained on reasonable terms.
SCIOS NOVA INC.
AND SUBSIDIARIES
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K.
(a) Exhibits
11.1 Statement regarding computation of per share earnings
for the three months ended September 30, 1995 and
September 30, 1994.
11.2 Statement regarding computation of per share earnings
for the nine months ended September 30, 1995 and
September 30, 1994.
(b) Reports on Form 8-K
None
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.
SCIOS NOVA INC.
Date: November 13, 1995 /S/ RICHARD L. CASEY
Richard L. Casey
Chairman of the Board, President and Chief
Executive Officer
Date: November 13, 1995 /S/ KEVIN McPHERSON
Kevin McPherson
Controller
(Acting Chief Accounting Officer)
INDEX TO EXHIBITS
SCIOS NOVA INC.
Quarterly Report on Form 10-Q
For the Quarter Ended September 30, 1995
Exhibit Description Method of Filing
11.1 Statement regarding computation of Filed
per share earnings for the three electronically
months ended September 30, 1995 herewith
and September 30, 1994.
11.2 Statement regarding computation of Filed
per share earnings for the nine electronically
months ended September 30, 1995 herewith
and September 30, 1994.