UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(X) Quarterly Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 for the quarterly period
ended March 31, 1999
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 1-6247
ALZA CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 77-0142070
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
950 Page Mill Road
P.O. Box 10950
Palo Alto, California 94303-0802
(Address of principal executive offices)
Registrant's telephone number, including area code (650) 494-5000
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 ( )
Number of shares outstanding of each of the registrant's classes
of common stock as of April 30, 1999:
Common Stock, $.01 par value - 100,809,606 shares
ALZA CORPORATION
FORM 10-Q for the Quarter Ended
March 31, 1999
INDEX
Part I. Financial Information
Item 1. Financial Statements
Condensed Consolidated Statement of Income 3
Condensed Consolidated Balance Sheet 4
Condensed Consolidated Statement of Cash Flows 5
Notes to Financial Statements 6-11
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations 12-24
Item 3. Quantitative and Qualitative Disclosures about
Market Risk 25
Part II. Other Information
Item 1. Legal Proceedings 25
Item 6. Exhibits and Reports on Form 8-K 26
Signatures 27
Exhibits
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ALZA CORPORATION
Condensed Consolidated Statement of Operations (unaudited)
(In millions, except per share amounts)
Quarter Ended
March 31,
1999 1998
______________________________
Revenues
Net sales $ 96.2 $ 66.8
Royalties, fees and other 58.9 50.4
Research and development 30.4 26.3
______________________________
Total revenues 185.5 143.5
Costs and expenses
Costs of products shipped 34.3 31.3
Research and development 44.1 40.2
Selling, general and
administrative 55.2 24.4
SEQUUS merger-related costs 32.6 -
______________________________
Total costs and expenses 166.2 95.9
______________________________
Operating income 19.3 47.6
Interest expense 14.9 14.2
Interest and other income (5.0) (6.9)
______________________________
Net interest and other
expense 9.9 7.3
______________________________
Income before income taxes 9.4 40.3
Provision for income taxes 5.7 13.8
______________________________
Net income $ 3.7 $ 26.5
==============================
Earnings per share
Basic $ 0.04 $ 0.27
==============================
Diluted $ 0.04 $ 0.27
==============================
Shares used in per share computation
Basic 100.4 98.2
==============================
Diluted 103.2 100.1
==============================
See accompanying notes.
ALZA Corporation
Condensed Consolidated Balance Sheet (unaudited)
(In millions)
March 31, December 31,
1999 1998
______________________________
ASSETS
Current assets:
Cash and cash equivalents $ 68.4 $ 110.1
Short-term investments 68.5 86.1
Receivables, net 166.5 148.6
Inventories, at cost:
Raw materials 16.1 18.2
Work in process 10.1 10.6
Finished goods 29.3 25.8
______________________________
Total inventories 55.5 54.6
Prepaid expenses and other
current assets 44.5 26.3
______________________________
Total current assets 403.4 425.7
Property, plant and equipment 501.5 504.7
Less accumulated depreciation
and amortization (130.1) (132.3)
______________________________
Net property, plant and equipment 371.4 372.4
Investments in long-term securities 347.3 317.9
Deferred product acquisition payments 272.9 279.1
Other assets 271.3 271.5
______________________________
Total assets $ 1,666.3 $ 1,666.6
==============================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 27.4 $ 59.6
Accrued liabilities 71.1 61.5
Other current liabilities 6.8 7.4
______________________________
Total current liabilities 105.3 128.6
5% convertible subordinated debentures 500.0 500.0
5-1/4% zero coupon convertible
subordinated debentures 428.2 422.6
Other long-term liabilities 74.0 83.5
Stockholders' equity:
Common stock and additional
paid-in capital 660.8 645.5
Accumulated other comprehensive loss (2.8) (10.6)
Accumulated deficit (99.2) (103.0)
______________________________
Total stockholders' equity 558.8 531.9
______________________________
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $ 1,666.3 $ 1,666.6
==============================
See accompanying notes.
ALZA CORPORATION
Condensed Consolidated Statement of Cash Flows (unaudited)
(In millions)
Quarter Ended
March 31,
1999 1998
____________________
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $ 3.7 $ 26.5
Non-cash adjustments to reconcile net income
to net cash provided by operating activities:
Depreciation and amortization 8.9 10.4
Amortization of product acquisition payments 6.3 2.6
Interest on 5-1/4% zero coupon convertible
subordinated debentures 5.6 5.2
Changes in current assets:
Receivables (17.9) (8.2)
Inventories (0.8) 4.4
Prepaid expenses and other current assets (4.4) (1.9)
Changes in liabilities:
Accounts payable (12.3) (8.9)
Accrued liabilities 11.8 (16.0)
Other long-term liabilities (3.4) (0.6)
Asset write-down 9.5 -
____________________
Total adjustments 3.3 (13.0)
____________________
Net cash provided by operating activities 7.0 13.5
CASH FLOWS FROM INVESTING ACTIVITIES:
Capital expenditures (15.8) (13.4)
Product acquisition payments (20.0) (5.0)
Purchases of available-for-sale securities (72.8) (99.1)
Sales and maturities of available-for-sale
securities 50.9 92.0
Maturities of available-for-sale securities 4.0 17.5
Other investing activities (1.5) (5.4)
____________________
Net cash used in investing activities (55.2) (13.4)
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuances of common stock 13.0 20.0
Principal payments on long-term debt (6.5) (2.9)
____________________
Net cash provided by financing activities 6.5 17.1
____________________
Net (decrease) increase in
cash and cash equivalents (41.7) 17.2
Cash and cash equivalents at
beginning of period 110.1 71.7
____________________
Cash and cash equivalents at end of period $ 68.4 $ 88.9
====================
See accompanying notes.
ALZA CORPORATION
Notes to Condensed Consolidated Financial Statements (unaudited)
NOTE 1. BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial
statements have been prepared in accordance with generally
accepted accounting principles for interim financial information.
The information at March 31, 1999 and for the quarters ended
March 31, 1999 and 1998 includes all adjustments (consisting only
of normal recurring adjustments) that the management of ALZA
Corporation ("ALZA") believes necessary for fair presentation of
the results for the periods presented.
Results for any interim period are not necessarily
indicative of results for any future interim period or for the
entire year. The accompanying financial statements should be
read in conjunction with the financial statements and notes
thereto included in ALZA's Annual Report on Form 10-K for the
year ended December 31, 1998 and the Form 8-K filed concurrently
with this Form 10-Q, which restates financial information for
prior periods to reflect the combined results of ALZA and SEQUUS
Pharmaceuticals, Inc. ("SEQUUS").
In March 1999, all of the outstanding shares of SEQUUS were
acquired by ALZA in a business combination accounted for as a
pooling-of-interests. Accordingly, the financial data for prior
periods has been restated to represent the combined financial
results of ALZA and SEQUUS (Note 4).
Comprehensive Income
Total comprehensive income includes net income plus other
comprehensive income, which, for ALZA, primarily comprises net
unrealized gains or losses on available-for-sale securities.
Other comprehensive income (loss) was $7.9 million and $(0.1)
million for the quarters ended March 31, 1999 and 1998,
respectively. Total comprehensive income was $11.6 million and
$26.4 million for the quarters ended March 31, 1999 and 1998,
respectively.
Supplemental Disclosures of Cash Flow Information
Noncash Investing and Financing Quarter Ended March 31,
Activities (In millions) 1999 1998
____________________________
Investment in low-income housing
in exchange for long-term debt $ - $ 10.1
Acquisition of building in lieu of
repayment of note receivable - 17.5
Reclassification
Certain amounts in the prior year's financial statements
have been reclassified to conform to the 1999 presentation.
NOTE 2. PER SHARE INFORMATION
Basic earnings per share is calculated by dividing net
income by the weighted average common shares outstanding for the
period. Diluted earnings per share is calculated by dividing net
income, as adjusted, by the weighted average common shares
outstanding for the period plus the dilutive effect of stock
options, warrants and convertible securities.
The following table sets forth the computation of ALZA's
basic and diluted earnings per share:
Quarter Ended March 31,
(in millions, except per share amounts) 1999 1998
_______________________________________________________________
NUMERATOR:
Basic
Net income $ 3.7 $ 26.5
===============================================================
Diluted
Net income $ 3.7 $ 26.5
===============================================================
DENOMINATOR:
Basic
Weighted average shares 100.4 98.2
===============================================================
Diluted
Weighted average shares 100.7 98.2
Effect of dilutive securities:
Employee stock options 2.5 1.7
Warrants - 0.2
_______________________________________________________________
Weighted average shares and
assumed conversions 103.2 100.1
===============================================================
Basic earnings per share $ 0.04 $ 0.27
===============================================================
Diluted earnings per share $ 0.04 $ 0.27
===============================================================
Stock options and warrants to purchase 1.1 million shares of
common stock were excluded from the diluted earnings per share
calculation for the quarters ended March 31, 1999 and 1998, because
the exercise price of the options and warrants was greater than the
average market price of the common shares during the quarter, and
therefore the effect of including those options and warrants would
have been anti-dilutive. Assumed conversions of ALZA's outstanding
5% convertible subordinated debentures due 2006 ("5% Debentures")
and 5-1/4% zero coupon convertible subordinated debentures due 2014
("5-1/4% Debentures") were not included in the diluted earnings per
share calculation for the periods presented, as their inclusion
would have been anti-dilutive.
NOTE 3. CRESCENDO PHARMACEUTICALS CORPORATION (RELATED PARTY)
Under the Development Agreement between ALZA and Crescendo
Pharmaceuticals Corporation ("Crescendo"), ALZA recorded product
development revenues of $23.3 million for the quarter ended March
31, 1999, compared with $19.9 million for the quarter ended March
31, 1998. ALZA expects that Crescendo will have expended all its
available funds during 2000.
Under the Technology License Agreement between ALZA and
Crescendo, ALZA recorded technology fee revenue from Crescendo of
$2.0 million for the first quarter of 1999, compared with $3.0
million for the first quarter of 1998, in accordance with the
terms of the agreement.
ALZA recognizes the technology fee from Crescendo when
earned. Since Crescendo owes the fee at the end of each month
if, and only if, at least two of the "Initial Products" remain in
development and/or have been licensed by ALZA at the end of each
month, the fee is not earned until the end of each month in which
these conditions are met. Development of any or all of the
Initial Products could be terminated by Crescendo at any time.
Three of the seven Initial Products were in development and/or
had been licensed at March 31, 1999. The monthly technology fee
payments are not guaranteed, and the conditions precedent to
their payment have not been fulfilled and cannot be fulfilled
before the end of each month. At the time ALZA accrues the
Crescendo technology fee, ALZA has no future performance
obligations to Crescendo in order to earn the fee that is being
accrued.
ALZA has an option to acquire an exclusive, royalty-bearing
license to each product developed by Crescendo under the
Development Agreement. The option is exercisable on a product-by-
product, country-by-country, basis. In December 1998, ALZA
exercised its option to obtain a worldwide license to OROS-
registered trademark- oxybutynin (marketed by ALZA in the United
States as Ditropan-registered trademark- XL). Under the license
agreement for this product, ALZA must pay Crescendo 2.5% of net
sales of the licensed product in the first year of sales, and 3%
in the second and third years. Thereafter, until 15 years after
the date of the first commercial sale of the product, the
percentage owed to Crescendo would be based upon development
costs paid by Crescendo; based upon current information this rate
is expected to be between 5% and 6%.
NOTE 4. ACQUISITION OF SEQUUS PHARMACEUTICALS, INC.
On March 16, 1999, ALZA completed a merger with SEQUUS by
acquiring all of SEQUUS' outstanding stock in a tax-free, stock-
for-stock transaction. SEQUUS stockholders received 0.4 shares
of ALZA common stock for each share of SEQUUS common stock. ALZA
issued 13.2 million shares in the merger. ALZA accounted for the
transaction as a pooling of interests. Accordingly, ALZA's
consolidated financial statements have been retroactively
restated for prior periods to include the combined financial
results of ALZA and SEQUUS. For the quarter ended March 31,
1999, the consolidated results of operations of the combined
companies have been presented and no adjustments were necessary
to conform the accounting practices of the two companies.
The table below presents the separate results of operations
for ALZA and SEQUUS for the periods prior to the merger and
combined results after the merger:
Merger-
related
(In millions) ALZA SEQUUS adjustments Total
_________________________________________________________________
Quarter Ended March 31, 1999
Revenues $ 173.1 $ 12.4 $ - $ 185.5
Net income 42.0 (5.7) (a)(32.6) 3.7
_________________________________________________________________
Quarter Ended March 31, 1998
Revenues $ 130.7 $ 12.4 $ - $ 143.5
Net income (loss) 28.3 (3.0) (b) 1.2 26.5
_________________________________________________________________
(a) Represents expenses incurred by ALZA related to the SEQUUS
merger.
(b) Represents a 40% tax benefit derived from SEQUUS' net loss.
As a result of the SEQUUS acquisition, ALZA incurred merger-
related costs that consisted of merger transaction costs, exit
costs and employee severance costs. Merger transaction costs
consisted primarily of fees for investment bankers, attorneys,
accountants, filing fees, financial printing costs and other
related charges. Exit costs include costs such as cancellation of
lease agreements and the write-down of SEQUUS assets that will
not be used in continuing operations. The following table shows
the details of the merger-related costs for the quarter ended
March 31, 1999:
Merger- Balance
related at March 31,
(In millions) costs Utilized 1999
_________________________________________________________________
Merger transaction costs $13.2 $ 5.4 $ 7.8
Exit costs 14.3 9.5 4.8
Employee severance 5.1 5.0 0.1
_______________________________
Total $32.6 $19.9 $12.7
===============================
NOTE 5. SEGMENT REPORTING
ALZA has two operating segments: ALZA Pharmaceuticals and
ALZA Technologies. The ALZA Pharmaceuticals segment includes
sales of products directly to the pharmaceutical marketplace,
research and development of potential products to be marketed by
ALZA (including revenues and expenses relating to products under
development with Crescendo) and co-promotion revenues for
products co-promoted by ALZA. The ALZA Technologies segment
includes research, development and manufacturing for client
companies and ALZA Pharmaceuticals, and royalties and fees
(including milestone payments) from ALZA's client companies under
joint product development and commercialization agreements. The
"Other" category primarily comprises corporate general and
administrative expenses, including finance, legal, human
resources, commercial development, executive and other functions
not directly attributable or allocated to the activities of the
operating segments, as well as rental and service fee revenues.
SEQUUS' net sales, costs of products shipped, research and
development for potential products to be marketed by ALZA and
sales and marketing expenses are included in ALZA
Pharmaceuticals; royalties and fee revenues and research and
development expenses are included in ALZA Technologies; and
general and administrative expenses are included in Other.
ALZA evaluates performance and allocates resources based on
operating income or loss from operations (before allocation of
certain general and administrative expenses, net interest
expense, investment gains and losses and income taxes). ALZA
does not assess segment performance or allocate resources based
on a segment's total assets, and therefore ALZA's assets are not
reported by segment. ALZA allocates certain long-lived assets to
operating segments for purposes of allocating depreciation and
amortization expense. The accounting policies of the reportable
segments are the same as those described in the summary of
significant accounting policies. ALZA accounts for intersegment
revenues based on prices negotiated between the segments, which
generally approximate the prices charged to third parties.
ALZA's reported segments are strategic operating units that
distribute products to different types of customers and provide
different types of services. They are managed differently
because ALZA Pharmaceuticals' sales and marketing efforts are
extensive and disparate from the revenue generation process
resulting from arrangements with client companies.
The following tables contain information about segment
operating income (loss) for the quarter ended March 31, 1999 and
1998:
Quarter Ended March 31,
(In millions) 1999 1998
____________________________________________________________
Revenues from external customers
Net sales
ALZA Pharmaceuticals $ 67.9 $ 41.8
ALZA Technologies 28.3 25.0
Royalties, fees and other
ALZA Pharmaceuticals 3.1 3.8
ALZA Technologies 55.4 46.3
Other 0.4 0.3
Research and development
ALZA Pharmaceuticals 23.2 19.5
ALZA Technologies 7.2 6.8
___________________________
Total $185.5 $143.5
===========================
Intersegment revenues
Net sales
ALZA Pharmaceuticals $ - $ -
ALZA Technologies 4.2 1.5
Research & development
ALZA Pharmaceuticals - -
ALZA Technologies 32.5 31.2
___________________________
Total $ 36.7 $ 32.7
===========================
Segment operating income (loss)
ALZA Pharmaceuticals $ (3.0) $ 2.2
ALZA Technologies 61.0 51.4
Other (38.7) (6.0)
___________________________
Total $ 19.3 $ 47.6
===========================
The following table contains a reconciliation of ALZA's
income before taxes to that reported by segment in the tables
above:
Quarter Ended March 31,
(In millions) 1999 1998
____________________________________________________________
Income (loss) before taxes
Total operating income for
reportable segments $ 58.0 $ 53.6
Other loss (38.7) (6.0)
Unallocated amounts:
Interest income 5.0 6.9
Interest expense (14.9) (14.2)
____________________________
Income before income taxes $ 9.4 $ 40.3
============================
NOTE 6. SUBSEQUENT EVENTS
In April 1999, AlZA sold three of its buildings located in
Palo Alto, California. The net proceeds from the sale of the
buildings were $6.4 million. ALZA will lease back these
buildings through December 31, 1999, when it expects to complete
occupancy of its new premises under construction in Mountain
View, California.
Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations
Notice Concerning Forward-Looking Statements
Some of the statements made in this Form 10-Q are forward-
looking in nature, including, without limitation, plans
concerning the commercialization of products, statements
concerning potential product sales, future costs of products
shipped (and gross margins), associated sales and marketing
expenses, plans concerning development of products and other
statements that are not historical facts. The occurrence of the
events described, and the achievement of the intended results,
are subject to various risk factors that could cause ALZA's
actual results to be materially different than those presented,
some or all of which are not predictable or within ALZA's
control. Many risks and uncertainties are inherent in the
pharmaceutical industry; others are more specific to ALZA's
business. Many of the significant risks related to ALZA's
business are described in ALZA's Annual Report on Form 10-K for
the year ended December 31, 1998.
RESULTS OF OPERATIONS
SUMMARY Quarter Ended March 31,
(In millions, except per share amounts) 1999 1998
________________________________________________________________
Revenues $ 185.5 $ 143.5
________________________________________________________________
Operating income 19.3 47.6
________________________________________________________________
Net income 3.7 26.5
________________________________________________________________
Diluted earnings per share 0.04 0.27
________________________________________________________________
ALZA's net income for the quarter ended March 31, 1999 was
$3.7 million or $0.04 per diluted share compared with a net
income of $26.5 million or $0.27 per diluted share for the
quarter ended March 31, 1998. Net income for the quarter ended
March 31, 1999 included merger-related charges of $24.8 million
(net of tax effect of $7.8 million), or $0.24 per share, and
should be excluded in order to analyze comparable operating
results for the two quarters.
On a comparable basis, for the quarter ended March 31, 1999,
ALZA's net income increased 8% to $28.5 million, or $0.28 per
diluted share, excluding the merger-related charges discussed
above, compared with $26.5 million or $0.27 per share for the
quarter ended March 31, 1998. The increase in net income for the
quarter ended March 31, 1999 resulted primarily from the
following:
- Net sales increased 44% to $96.2 million for the quarter
ended March 31, 1999 from $66.8 million for the quarter ended
March 31, 1998. The increase in sales resulted from a 63%
increase in sales of products by ALZA Pharmaceuticals to $67.9
million for the quarter ended March 31, 1999 from $41.8 million
for the quarter ended March 31, 1998. This increase in ALZA
Pharmaceuticals' sales can be primarily attributed to $22.0
million in sales of Ditropan-registered trademark- XL (oxybutynin
chloride), which was launched on February 1, 1999, and a 29%
increase in sales of Doxil-registered trademark-/Caelyx-
registered trademark- (doxorubicin HCl liposome injection) for
the quarter ended March 31, 1999 compared to the quarter ended
March 31, 1998. In addition, revenues from contract
manufacturing increased 13% to $28.3 million for the quarter
ended March 31, 1999 from $25.0 million for the quarter ended
March 31, 1998 due to higher shipments of NicoDerm-registered
trademark- CQ-trademark- (nicotine) to SmithKline Beecham ("SB"),
Covera-HS-trademark- (verapamil) to G.D. Searle & Co. ("Searle")
and Glucotrol XL-registered trademark- (glipizide) to Pfizer Inc.
("Pfizer").
- Gross margin increased to 64% for the quarter ended March
31, 1999 from 53% for the quarter ended March 31, 1998. The
increase in gross margin was due to an increase in sales of ALZA-
marketed products as a percentage of total net sales and, to a
lesser extent, an improvement in margins of contract manufactured
products.
- Royalties, fees and other revenues increased 17% to $58.9
million for the quarter ended March 31, 1999 from $50.4 million
for the quarter ended March 31, 1998. The increase in royalties
is primarily due to an increase in royalties on sales of
Duragesic-registered trademark- (fentanyl) by Janssen
Pharmaceutica, Inc.(together with its affiliates, "Janssen"),
NicoDerm CQ by SB and Cardura XL-registered trademark- (doxazosin
mesylate) and Glucotrol XL by Pfizer, partially offset by a
decrease in royalties from sales of Procardia XL-registered
trademark- by Pfizer. Fee revenue decreased for the quarter
ended March 31, 1999 compared to the quarter ended March 31,
1998.
- Research and development revenues increased 16% to $30.4
million for the quarter ended March 31, 1999 from $26.3 million
for the quarter ended March 31, 1998. The increase is due to
research and development revenue from Crescendo of $23.3 million
for the quarter ended March 31, 1999 compared with $19.9 million
for the quarter ended March 31, 1998.
- ALZA's effective tax rate declined to 32% for the quarter
ended March 31, 1999 compared to 34% for the quarter ended March
31, 1998.
Substantially offsetting these contributions to net income
in 1999 were the following:
- Research and development expenses increased 10% to $44.1
million for the quarter ended March 31, 1999 from $40.2 million
for the quarter ended March 31, 1998.
- Selling, general and administrative expenses increased 127%
to $55.2 million for the quarter ended March 31, 1999 from $24.4
million for the quarter ended March 31, 1998. The increase was
due to the expansion of the sales organization in 1998, the
increase in marketing expenditures related to the launch of
Ditropan XL in the first quarter of 1999 and increased marketing
expenses for ALZA's expanded product portfolio.
- Interest income declined 27% to $5.0 million for the quarter
ended March 31, 1999 compared with $6.9 million for the quarter
ended March 31, 1998, primarily due to lower cash balances as a
result of a payment in the third quarter of 1998 of $91.2 million
for the exercise of the option to acquire all of the outstanding
limited partnership interests in ALZA TTS Research Partners, Ltd.
(the "TTS Partnership").
OPERATING SEGMENT SUMMARY
ALZA has two operating segments: ALZA Pharmaceuticals and
ALZA Technologies.
ALZA Pharmaceuticals markets and sells products developed by
ALZA Technologies or others directly to the pharmaceutical
marketplace in the United States and Canada and to distributors
who sell such products outside the United States and Canada.
ALZA Pharmaceuticals also conducts product development, co-
promotes products with third parties, and engages ALZA
Technologies and others to conduct product development and
manufacture products for ALZA Pharmaceuticals.
ALZA Technologies conducts research and development of
ALZA's drug delivery technologies and products for ALZA
Pharmaceuticals and Crescendo and other pharmaceutical company
clients, and manufactures products for sale by ALZA
Pharmaceuticals and client companies.
The "Other" category primarily comprises corporate general
and administrative activities and the associated costs related to
finance, legal, human resources, commercial development,
executive and other functions not directly attributable (or
allocated) to the activities of the operating segments, as well
as rental and service fee revenues.
SEQUUS' net sales, costs of products shipped, research and
development for products marketed by, and potential products to be
marketed by, ALZA and sales and marketing expenses are included in
ALZA Pharmaceuticals; royalties and fee revenues, research and
development revenues and related expenses (largely for activities
undertaken on behalf of ALZA Pharmaceuticals) are included in ALZA
Technologies; and general and administrative expenses are included
in Other.
OPERATING SEGMENT SUMMARY Quarter Ended March 31,
(In millions) 1999 1998
_________________________________________________________________
Revenues
ALZA PHARMACEUTICALS $ 94.2 $ 65.1
ALZA TECHNOLOGIES 127.6 110.8
OTHER 0.4 0.3
_________________________________________________________________
Total segment revenues 222.2 176.2
Intersegment elimination (36.7) (32.7)
_________________________________________________________________
Total revenues $ 185.5 $ 143.5
_________________________________________________________________
Operating income (loss)
ALZA PHARMACEUTICALS $ (3.0) $ 2.2
ALZA TECHNOLOGIES 61.0 51.4
OTHER (38.7) (6.0)
_________________________________________________________________
Total operating income $ 19.3 $ 47.6
_________________________________________________________________
ALZA PHARMACEUTICALS
The decrease in ALZA Pharmaceuticals' operating income in
the quarter ended March 31, 1999 compared to the quarter ended
March 31, 1998, was due to a 55% increase in operating expenses
reflecting the substantial expansion of ALZA's sales organization
and increased marketing expenses related to the launch of
Ditropan-registered trademark- XL and its expanded product
portfolio. The increase in operating expenses was partially
offset by a 63% increase in net sales of ALZA-marketed products.
ALZA TECHNOLOGIES
Operating income for ALZA Technologies increased 19% in the
quarter ended March 31, 1999 compared to the quarter ended March
31, 1998. This increase was primarily due to a 20% increase in
royalties, fees and other revenues and a 13% increase in contract
manufacturing sales.
OTHER
Operating loss for the "Other" segment increased
significantly in the quarter ended March 31, 1999 compared to the
quarter ended March 31, 1998. The increase in the operating loss
was due primarily to $32.6 million of merger-related charges
recorded in the quarter ended March 31, 1999 related to the
SEQUUS acquisition.
NET SALES
Net Sales Quarter Ended March 31,
(In millions) 1999 1998
__________________________________________________________________
ALZA PHARMACEUTICALS
Ditropan-registered trademark- XL $ 22.0 $ -
Doxil-registered trademark-/
Caelyx-registered trademark- 14.3 10.7
Ethyol-registered trademark- 8.6 8.1
Mycelex-registered trademark- Troche 5.0 5.9
Elmiron-registered trademark- 4.9 7.0
Testoderm-registered trademark- TTS line 4.5 2.0
Other 8.6 8.1
__________________________________________________________________
Total 67.9 41.8
__________________________________________________________________
ALZA TECHNOLOGIES
Contract manufacturing 28.3 25.0
Intersegment 4.2 1.5
__________________________________________________________________
Total 32.5 26.5
__________________________________________________________________
Intersegment eliminations (4.2) (1.5)
__________________________________________________________________
Total net sales $ 96.2 $ 66.8
__________________________________________________________________
Total net sales as a percentage
of total revenues 52% 47%
__________________________________________________________________
ALZA PHARMACEUTICALS
Included in net sales of ALZA-marketed products are sales of
the products marketed directly by ALZA in the United States and
Canada, and sales of those products in other countries through
distributors. Net sales of ALZA-marketed products increased 63%
for the quarter ended March 31, 1999 compared to the quarter
ended March 31, 1998, resulting from initial sales of Ditropan
XL, which was launched in February 1999, and a 29% increase in
sales of Doxil for the quarter ended March 31, 1999 compared to
the quarter ended March 31, 1998. Partially offsetting these
increases was a 31% decline in sales of Elmiron-registered
trademark- (pentosan polysulfate sodium) and a 14% decline in
sales of Mycelex-registered trademark- (clotrimazole) Troche.
Net sales of ALZA-marketed products can be expected to vary
from quarter to quarter, particularly in the first years after
launch of a new product. Ditropan XL was launched in the first
quarter of 1999, and Doxil, Ethyol-registered trademark-
(amifostine), Elmiron and Testoderm-registered trademark- TTS
(Testosterone Transdermal System) were cleared for marketing
during the past few years. These products have not yet achieved
their steady-state sales levels. Wholesaler stocking patterns,
managed care and formulary acceptance, the introduction of
competitive products, and acceptance by patients and physicians
will affect future sales of these products.
ALZA TECHNOLOGIES
Net sales from contract manufacturing include sales
generated from contract manufacturing activities for ALZA's
client companies and for ALZA Pharmaceuticals. Net sales from
contract manufacturing increased 13% for the quarter ended March
31, 1999 compared to the quarter ended March 31, 1998, primarily
due to an increase in ALZA shipments of NicoDerm CQ to SB and
Covera-HS to Searle.
The timing and quantities of orders for products marketed by
client companies are not within ALZA's control. Net sales to
client companies can be expected to fluctuate from period to
period, sometimes significantly, depending on the volume, mix and
timing of orders of products shipped to client companies, and in
some quarters, due to the shipment of launch quantities of
products to clients.
GROSS MARGIN
Quarter Ended March 31,
Gross margin 1999 1998
________________________________________________________________
ALZA PHARMACEUTICALS (1) 83% 76%
ALZA TECHNOLOGIES (1) 20% 13%
________________________________________________________________
Gross margin(2) 64% 53%
________________________________________________________________
(1) Includes intersegment revenues or expenses.
(2) After intersegment eliminations.
The increase in total gross margin for the quarter ended
March 31, 1999 compared to March 31, 1998 was due to increased
sales of higher-margin products by ALZA Pharmaceuticals and, to a
lesser extent, an increase in margins on products shipped by ALZA
Technologies to client companies. ALZA expects its gross margin
on net sales to increase from historical rates over the longer
term, although quarter-to-quarter fluctuations, even significant
ones, can be expected to continue to occur. A trend of higher
gross margins may be achieved through a proportionate increase in
direct sales by ALZA Pharmaceuticals in relation to sales from
contract manufacturing and, to a lesser extent, increased
utilization of capacity and greater operating efficiencies by
ALZA Technologies.
ALZA PHARMACEUTICALS
The gross margin on net sales of ALZA-marketed products
increased in the quarter ended March 31, 1999 compared to the
quarter ended March 31, 1998 due to a shift in product mix toward
sales of higher-margin products, including Ditropan XL, which was
launched February 1, 1999.
ALZA TECHNOLOGIES
The gross margin on net sales of products manufactured by
ALZA Technologies for sale by client companies and ALZA
Pharmaceuticals increased in the quarter ended March 31, 1999
compared with the quarter ended March 31, 1998 as a result of an
increase in shipments of higher-margin products to client
companies. ALZA Technologies' gross margin on its contract
manufacturing sales is usually considerably lower than ALZA
Pharmaceuticals' gross margin on its sales of ALZA-marketed
products. ALZA's client-funded product development agreements
generally provide for a supply price that is intended to cover
ALZA's costs to manufacture the product plus a small margin.
ALZA also receives royalties on the clients' sales of the
products, which are included in royalties, fees and other
revenues. Sales to ALZA Pharmaceuticals are based upon
negotiated prices, which generally approximate the prices charged
to third parties.
ROYALTIES, FEES AND OTHER REVENUES
Royalties, Fees and Other Revenues Quarter Ended March 31,
(In millions) 1999 1998
_________________________________________________________________
ALZA PHARMACEUTICALS $ 3.1 $ 3.8
ALZA TECHNOLOGIES 55.4 46.3
OTHER 0.4 0.3
_________________________________________________________________
Total royalties, fees and
other revenues $ 58.9 $ 50.4
_________________________________________________________________
Percentage of total revenues 32% 35%
_________________________________________________________________
ALZA PHARMACEUTICALS
For the quarter ended March 31, 1999, fee revenue for AlZA
Pharmaceuticals included technology fees of $2.0 million from
Crescendo compared to $3.0 million from Crescendo for the quarter
ended March 31, 1998, as provided in the agreements between ALZA
and Crescendo.
ALZA TECHNOLOGIES
Royalties, fees and other revenues increased 20% for the
quarter ended March 31, 1999, compared to the quarter ended March
31, 1998. The first quarter increase in royalties, fees and
other revenues was primarily due to an increase of 26% in
royalties resulting from higher royalties on product sales of
Duragesic, NicoDerm CQ, Cardura XL, and Glucotrol XL, partially
offset by a decrease in royalties from sales of Procardia XL.
Sales of Procardia XL, as reported by Pfizer, decreased 27%
in the quarter ended March 31, 1999 compared to the quarter ended
March 31, 1998. Several companies have filed Abbreviated New
Drug Applications ("ANDA") with the United States Food and Drug
Administration ("FDA") requesting clearance to market generic
equivalents to Procardia XL, and one company has received
tentative FDA approval of its ANDA. Pfizer has filed suit
against these companies for infringement of patent rights
relating to the nifedipine active drug substance in Procardia XL,
and is also involved in litigation with the FDA and one of the
ANDA applicants concerning the regulatory status of the
applicant's product. It is not possible to predict the timing
and amount of the negative impact on sales of Procardia XL that
will result from competition from these or other potential
generic sustained release nifedipine products.
During the next several years, ALZA intends to continue to
reduce its dependence on royalties and fees by further expanding
ALZA's sales and marketing activities and by directly marketing
and selling more products. However, there can be no assurance
that ALZA will be successful in undertaking this expansion, or
that any expanded sales and marketing activities will be
successful, due to factors such as the risks associated with
developing, clinically testing and obtaining regulatory clearance
of products for ALZA marketing, the difficulties and costs
associated with acquiring products from third parties for ALZA to
market, the length of the regulatory approval process, the
uncertainties surrounding the acceptance of new products by the
intended markets, the marketing of competitive products, the
risks relating to patents and proprietary rights and the current
health care cost containment environment in the United States.
ALZA expects that, in the near term, royalties on sales by
clients of currently marketed products will continue to be a
substantial contributor to net income.
RESEARCH AND DEVELOPMENT
Research and Development Revenues Quarter Ended March 31,
(In millions) 1999 1998
_________________________________________________________________
ALZA PHARMACEUTICALS
Crescendo $ 23.2 $ 19.5
_________________________________________________________________
ALZA TECHNOLOGIES
Crescendo $ - $ 0.5
Other clients 7.2 6.3
Intersegment 32.5 31.2
_________________________________________________________________
Total 39.7 38.0
_________________________________________________________________
Intersegment elimination (32.5) (31.2)
_________________________________________________________________
Total research and development revenues $ 30.4 $ 26.3
_________________________________________________________________
Percentage of total revenues 16% 18%
_________________________________________________________________
ALZA PHARMACEUTICALS
ALZA Pharmaceuticals derives research and development
revenues from Crescendo. Revenues from Crescendo are offset by
intersegment charges from ALZA Technologies for research and
development expenses incurred on behalf of ALZA Pharmaceuticals
related to products under development for marketing by ALZA
Pharmaceuticals. ALZA expects that Crescendo will have expended
all its available funds during 2000.
ALZA has an option to acquire an exclusive, royalty-bearing
license to each product developed by Crescendo under the
Development Agreement. The option is exercisable on a product-by-
product, country-by-country, basis. In December 1998, ALZA
exercised its option to obtain a worldwide license to OROS
oxybutynin (Ditropan XL). Under the license agreement, ALZA must
pay Crescendo 2.5% of net sales of the licensed product for the
first year of sales and 3% for the second and third years.
Thereafter, until 15 years after the date of the first commercial
sale of the product, the percentage owed to Crescendo would be
based upon development costs paid by Crescendo; based upon
current information this rate is expected to be between 5% and
6%.
ALZA TECHNOLOGIES
Research and development revenues increased 4% for the
quarter ended March 31, 1999 compared to the quarter ended March
31, 1998 reflecting an increase in product development activities
under agreements with client companies.
Research and Development Expenses Quarter Ended March 31,
(In millions) 1999 1998
_________________________________________________________________
ALZA PHARMACEUTICALS
Intersegment $ 32.5 $ 31.2
Product development expense 6.0 3.7
_________________________________________________________________
Total ALZA Pharmaceuticals 38.5 34.9
_________________________________________________________________
ALZA TECHNOLOGIES 38.1 36.5
_________________________________________________________________
Intersegment elimination (32.5) (31.2)
_________________________________________________________________
Total research and development
expenses $ 44.1 $ 40.2
_________________________________________________________________
As a percentage of total revenues 24% 28%
_________________________________________________________________
ALZA PHARMACEUTICALS
ALZA Pharmaceuticals engages ALZA Technologies to perform
research and development services, which are charged under the
same formula ALZA charges client companies. Expenses related to
these services were relatively constant for the quarters ended
March 31, 1999 and 1998. Product development expense increased
in the quarter ended March 31, 1999 compared to the quarter ended
March 31, 1998 primarily due to an increase in development costs
related to products currently marketed by ALZA Pharmaceuticals.
ALZA TECHNOLOGIES
Research and development expenses increased 4% in the
quarter ended March 31, 1999, compared to the quarter ended March
31, 1998, reflecting an increase in product development
activities under agreements with client companies.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
Selling, general and administrative expenses
Quarter Ended March 31,
(In millions) 1999 1998
__________________________________________________________________
ALZA PHARMACEUTICALS
Sales and marketing expenses $ 42.8 $ 15.4
__________________________________________________________________
ALZA PHARMACEUTICALS
Amortization of product acquisition payments 3.9 2.6
ALZA TECHNOLOGIES
Amortization of product acquisition payments 2.2 -
__________________________________________________________________
Total 6.1 2.6
__________________________________________________________________
OTHER
General and administrative expenses 6.3 6.4
__________________________________________________________________
Total selling, general and
administrative expenses $ 55.2 $ 24.4
==================================================================
Total selling, general and administrative
expenses as a percentage of total revenues 30% 17%
__________________________________________________________________
ALZA PHARMACEUTICALS
Sales and marketing expense increased substantially for the
quarter ended March 31, 1999 compared to the quarter ended March
31, 1998 as a result of the significant increase in the size of
ALZA's sales organization, the increased sales and marketing
activities due to the launch of Ditropan XL and the increased
marketing expense for ALZA's expanded product portfolio. During
the second half of 1998, ALZA expanded its sales organization by
approximately 260 sales professionals. In 1998, ALZA entered
into an agreement with UCB Pharma, Inc. ("UCB Pharma") under
which approximately 350 sales professionals of UCB Pharma are co-
promoting Ditropan XL in the United States with ALZA. UCB Pharma
receives payments based on sales of Ditropan XL above certain
levels, as well as payments for calls made. The term of the co-
promotion arrangement continues through March 2002.
Amortization of product acquisition payments for the ALZA
Pharmaceuticals segment increased 50% in the quarter ended March
31, 1999 compared to the quarter ended March 31, 1998 due to the
amortization of payments for products that were acquired in the
second half of 1998 and the amortization of additional payments
made since the first quarter of 1998 related to product
acquisitions.
ALZA TECHNOLOGIES
Amortization of product acquisition payments for ALZA
Technologies relates to three months amortization of the $91.2
million exercise price paid in August 1998 to acquire all of the
outstanding limited partnership interests in the TTS Partnership.
NET INTEREST
Net Interest Quarter Ended March 31,
(In millions) 1999 1998
_________________________________________________________________
Interest and other income $ (5.0) $ (6.9)
Interest expense 14.9 14.2
_________________________________________________________________
Net interest and other expense $ 9.9 $ 7.3
_________________________________________________________________
Interest and other income declined 28% for the quarter ended
March 31, 1999 compared to the quarter ended March 31, 1998 due
to significantly lower average invested cash balances. ALZA's
lower cash balance in the first quarter of 1999 was attributable
to the payment of $91.2 million for the exercise of the option to
acquire all of the outstanding limited partnership interest in
the TTS Partnership, which occurred in the third quarter of 1998.
Interest expense was slightly higher for the quarter ended March
31, 1999 as compared to the same period for 1998, primarily due
to accreted interest on ALZA's outstanding 5-1/4% Debentures.
Effective Tax Rate
For the first quarter of 1999, the effective income tax rate
was 32%, excluding the tax effect of $7.8 million on merger-
related costs of $32.6 million, compared to 34% for the first
quarter of 1998. ALZA's annual effective combined federal and
state income tax rate for 1999 is estimated to be 32% assuming
utilization of SEQUUS' net operating losses. The actual
effective income tax rate will depend upon the actual level of
earnings, potential changes in the tax laws, the amount of
investment and research credits available and ALZA's ability to
utilize such credits.
LIQUIDITY AND CAPITAL RESOURCES
LIQUIDITY AND CAPITAL RESOURCES March 31, December 31,
(In millions) 1999 1998
__________________________________________________________________
Working capital $ 298.1 $ 297.1
Cash and investments 484.2 514.1
Total assets 1,666.3 1,666.6
Long-term debt 962.7 966.1
__________________________________________________________________
Quarter ended March 31,
(In millions) 1999 1998
__________________________________________________________________
Net cash provided by (used in)
operating activities $ 7.0 $ (13.0)
Capital expenditures 15.8 13.4
Product acquisition payments 20.0 5.0
__________________________________________________________________
Cash flow provided by operating activities for the quarter
ended March 31, 1999 was $7.0 million (or $17.3 million excluding
payments for merger-related expenses) compared to $13.5 million
for the quarter ended March 31, 1998.
ALZA's capital spending for the quarter ended March 31, 1999
was $15.8 million for additions to facilities and equipment to
support its research, development and manufacturing activities,
compared to capital spending of $13.4 million in the same period
in 1998. While ALZA believes its current facilities and
equipment (including the facilities currently under construction)
are sufficient to meet its current operating requirements, ALZA
is expanding its facilities and equipment to support its medium-
term and long-term requirements. Capital expenditures during the
remainder of 1999 are expected to continue to increase over 1998
levels to complete the Mountain View facilities discussed below.
As a result of ALZA's investment in a real estate joint
venture and construction of buildings in Mountain View,
California, which are scheduled to be completed in late 1999,
ALZA has been evaluating its real estate holdings and future
facilities needs. In April 1999, ALZA sold three of its
buildings located in Palo Alto, California for a total of $6.4
million. ALZA will lease back these buildings through December
31, 1999, when it expects to complete occupancy of the new
buildings in Mountain View. ALZA expects to sell or lease
certain other Palo Alto and/or Mountain View properties in the
near term, which could result in additional gains in 1999 and
lease income in 2000 and beyond.
ALZA believes that its existing cash and investment balances
are adequate to fund its cash needs for 1999 and beyond. In
addition, should the need arise, ALZA believes it would be able
to borrow additional funds or otherwise raise additional capital.
ALZA may consider using its capital to make strategic investments
or to acquire or license technology or products.
Year 2000
ALZA is reliant upon its computer systems and applications,
including scientific and manufacturing equipment containing
computer-related components, to conduct its business. Key
internal systems and applications include manufacturing
production management, raw materials supply, inventory control,
research and development activities and project management,
documentation, marketing and financial systems. The majority of
ALZA's significant operating and accounting systems are currently
Year 2000 compliant. The financial and accounting systems that
are not currently Year 2000 compliant have been identified and
are in the process of being upgraded or replaced. Other internal
systems have been inventoried and evaluated for Year 2000
compliance. Internal systems will be upgraded or replaced or
contingency plans will be developed, as necessary. Year 2000
issues are expected to be resolved with respect to all systems
critical to ALZA's business by the end of 1999.
In addition to its internal systems, ALZA is also reliant
upon the capabilities of the computer systems of its
distributors, customers, vendors, banks, and government agencies.
ALZA has initiated communications with third parties with whom it
has material direct business relationships in order to determine
their level of Year 2000 compliance.
Year 2000 costs incurred to date have not been material.
Total costs to modify ALZA's systems for Year 2000 compliance are
expected to be less than $2.0 million. Such costs do not include
normal system upgrades and replacements and the actual financial
impact could exceed this estimate.
If ALZA is unable to bring its systems into compliance in
the expected timeframe, any noncompliance could have a material
impact on ALZA's operations, and could result in delays or
failures in manufacturing, research and development and similar
activities. The extent of such impact cannot presently be
determined. ALZA may also experience delays or failures in
manufacturing, distribution, order entry, order processing,
product shipping and distribution, invoicing, payment, or similar
normal business activities, if certain third party distributors,
customers, vendors and banks are not Year 2000 compliant. In
addition, ALZA may experience some delay in obtaining approvals
to market ALZA products from government agencies if government
computer systems are not Year 2000 compliant. There can be no
assurances that third parties' failure to ensure Year 2000
compliance would not have an adverse impact on ALZA's financial
condition or results of operations.
ALZA is currently identifying and developing specific
contingency plans intended to mitigate the effects of any
potential Year 2000 disruption, including the effects of
operational problems and costs that may result from a failure of
ALZA and certain third parties to complete efforts necessary to
achieve Year 2000 compliance on a timely basis or from abnormal
buying patterns in anticipation of Year 2000. ALZA expects to
have contingency plans in place by the middle of 1999.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Financial market risks related to changes in interest rates
and foreign currency exchange rates are described in Part II,
Item 7A, Quantitative and Qualitative Disclosure About Market
Risk, in ALZA's Annual Report on Form 10-K for the year ended
December 31, 1998 and the Form 8-K filed concurrently with this
Form 10-Q, which restates financial information for prior periods
to reflect the combined results of ALZA and SEQUUS.
ALZA is exposed to equity price risks on the marketable
portion of equity securities included in its portfolio of
investments entered into to further its business and strategic
objectives. These investments are generally in small
capitalization stocks in the pharmaceutical and biotechnology
industry sector, in companies with which ALZA has research and
development or product agreements. ALZA typically does not
attempt to reduce or eliminate its market exposure on these
securities. A 20% adverse change in equity prices would result
in an approximate $14 million decrease in ALZA'S available-for-
sale securities, based upon a sensitivity analysis performed on
ALZA's financial position at March 31, 1999. However, actual
results may differ materially.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Product liability suits have been filed against Janssen and
ALZA from time to time relating to the Duragesic product.
Janssen is managing the defense of these suits in consultation
with ALZA under an agreement between the parties.
Historically, the cost of resolution of liability claims
against ALZA (including product liability claims) has not been
significant,
and ALZA is not aware of any asserted or unasserted claims
pending against it, including the suits mentioned above, the
resolution of which would have a material adverse impact on the
operations or financial position of ALZA.
Pursuant to a Remedial Action Order No. HSA 88/89-016 issued
by the California Department of Toxic Substances Control
("DTSC"), ALZA has been named as one of a number of potentially
responsible parties in connection with the cleanup and
environmental remediation of the Hillview-Porter Regional Site
Project near ALZA's Palo Alto facilities. The purpose of the
DTSC action is, in part, to apportion responsibility for cleanup
costs among the parties involved. Cleanup costs for the entire
region have been estimated at approximately $16 million. ALZA
believes that it did not discharge any of the chemicals of
concern at the site in question. ALZA does not believe that its
liability in this matter, if any, will be material.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits:
3.1 Composite By-laws of ALZA Corporation
27 Financial Data Schedule
(b) On March 16, 1999, ALZA filed a current report on Form 8-K
to report the closing of its acquisition of SEQUUS.
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.
ALZA CORPORATION
Date: May 12, 1999 By: /s/ E. Mario
________________________________
Dr. Ernest Mario
Chairman and Chief
Executive Officer
Date: May 12, 1999 By: /s/ Bruce C. Cozadd
________________________________
Bruce C. Cozadd
Senior Vice President and
Chief Financial Officer
EXHIBIT INDEX
Exhibit
3.1 Composite bylaws of ALZA Corporation
27 Financial Data Schedule