UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(X) Quarterly Report Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934 for the quarterly period
ended June 30, 2000
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.)
1900 Charleston Road
P.O. Box 10950
Mountain View, California 94039-7210
(Address of principal executive offices)
Registrant's telephone number, including area code (650) 564-5000
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 July 31, 2000:
Common Stock, $.01 par value - 105,011,543 shares
ALZA CORPORATION
FORM 10-Q for the Quarter Ended
June 30, 2000
INDEX
Part I. Financial Information
Item 1. Financial Statements
Condensed Consolidated Statement of Operations 3
Condensed Consolidated Balance Sheet 4
Condensed Consolidated Statement of Cash Flows 5
Notes to Condensed Consolidated Financial Statements 6-13
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations 14-28
Item 3. Quantitative and Qualitative Disclosures about
Market Risk 28
Part II. Other Information
Item 1. Legal Proceedings 29
Item 4. Submission of Matters to a Vote of Security Holders 29
Item 6. Exhibits and Reports on Form 8-K 30
Signatures 31
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 Six Months Ended
June 30, June 30,
2000 1999 2000 1999
__________________________________________________________________
Revenues:
Net sales $134.6 $103.2 $243.4 $199.4
Royalties, fees
and other 87.2 54.8 154.3 113.7
Research and development 32.0 37.2 57.4 67.6
__________________________________________________________________
Total revenues 253.8 195.2 455.1 380.7
Costs and expenses:
Costs of products
shipped 42.0 40.3 76.7 74.6
Research and development 47.9 47.8 92.7 91.9
Selling, general and
administrative 85.6 60.4 157.6 115.6
Merger-related expenses - - - 32.6
__________________________________________________________________
Total costs
and expenses 175.5 148.5 327.0 314.7
__________________________________________________________________
Operating income 78.3 46.7 128.1 66.0
Interest expense 15.3 14.8 30.7 29.7
Interest and other income (7.2) (18.4) (12.6) (23.4)
__________________________________________________________________
Net interest and other
(income) expense 8.1 (3.6) 18.1 6.3
__________________________________________________________________
Income before income taxes 70.2 50.3 110.0 59.7
__________________________________________________________________
Provision for income taxes 21.8 16.1 34.1 21.8
__________________________________________________________________
Net income $ 48.4 $ 34.2 $ 75.9 $ 37.9
==================================================================
Earnings per share
Basic $ 0.47 $ 0.34 $ 0.74 $ 0.38
==================================================================
Diluted $ 0.44 $ 0.33 $ 0.72 $ 0.37
==================================================================
Shares used in per share computation
Basic 102.8 100.7 102.4 100.5
==================================================================
Diluted 130.4 114.9 129.7 102.9
==================================================================
See accompanying notes.
ALZA CORPORATION
Condensed Consolidated Balance Sheet (unaudited)
(In millions)
June 30, December 31,
2000 1999
________________________________________________________________
ASSETS
Current assets:
Cash and cash equivalents $ 183.8 $ 149.4
Short-term investments 80.1 68.0
Receivables, net 166.6 125.7
Inventories, at cost:
Raw materials 19.9 26.0
Work in process 17.8 10.4
Finished goods 35.1 32.6
______________________
Total inventories 72.8 69.0
Prepaid expenses and other
current assets 20.3 20.6
______________________
Total current assets 523.6 432.7
Property, plant and equipment 575.7 563.5
Less accumulated depreciation
and amortization (160.2) (145.7)
______________________
Net property, plant and equipment 415.5 417.8
Long-term investments 387.8 381.5
Deferred product acquisition costs 278.3 283.4
Cash surrender value of life insurance 178.8 148.4
Other assets 195.0 188.7
______________________
TOTAL ASSETS $1,979.0 $1,852.5
=======================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 45.2 $ 75.9
Accrued liabilities 64.8 51.5
Other current liabilities 7.5 7.5
______________________
Total current liabilities 117.5 134.9
5% convertible subordinated debentures 495.4 495.5
5 1/4% zero coupon convertible
subordinated debentures 455.3 443.7
Other long-term liabilities 84.4 86.6
Stockholders' equity:
Common stock and additional
paid-in capital 764.9 706.6
Accumulated other comprehensive loss (2.4) (2.8)
Retained earnings (accumulated deficit) 63.9 (12.0)
______________________
Total stockholders' equity 826.4 691.8
______________________
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $1,979.0 $1,852.5
=======================
See accompanying notes.
ALZA CORPORATION
Condensed Consolidated Statement of Cash Flows (unaudited)
(In millions)
Six Months Ended
June 30,
2000 1999
__________________________________________________________________
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $ 75.9 $ 37.9
Non-cash adjustments to reconcile net income
to net cash provided by operating activities:
Depreciation and amortization 25.3 20.0
Amortization of product acquisition payments 11.7 12.2
Interest on 5 1/4% zero coupon convertible
subordinated debentures 11.6 11.2
Undistributed income from real estate
joint venture (2.2) -
Gain on sale of real estate and other
assets, net (1.9) (12.5)
Asset write-down - 10.7
Changes in current assets:
Receivables (38.8) (18.1)
Inventories (6.9) (4.6)
Prepaid expenses and other current assets - (15.7)
Prepaid premiums and increase in cash
surrender value of life insurance (30.3) (28.9)
Changes in liabilities:
Accounts payable (31.0) (1.8)
Accrued liabilities 25.3 0.4
Other long-term liabilities 6.1 1.9
___________________
Total adjustments (31.1) (25.2)
___________________
Net cash provided by operating activities 44.8 12.7
CASH FLOWS FROM INVESTING ACTIVITIES:
Capital expenditures (17.7) (40.8)
Proceeds from sale of real estate
and other assets 4.8 20.3
Product acquisition payments (5.8) (20.0)
Purchases of available-for-sale securities (48.4) (102.5)
Sales and maturities of available-for-sale
securities 30.9 113.2
Other investing activities (10.3) (17.2)
___________________
Net cash used in investing activities (46.5) (47.0)
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuances of common stock 43.5 20.0
Principal repayments of long-term debt, net (7.4) (3.6)
___________________
Net cash provided by financing activities 36.1 16.4
___________________
Net (decrease) increase in
cash and cash equivalents 34.4 (17.9)
___________________
Cash and cash equivalents at
beginning of period 149.4 110.1
___________________
Cash and cash equivalents at end of period $ 183.8 $ 92.2
===================
See accompanying notes.
ALZA CORPORATION
Notes to Condensed Consolidated Financial Statements (unaudited)
NOTE 1. BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
The accompanying unaudited condensed consolidated financial
statements have been prepared in accordance with generally
accepted accounting principles for interim financial information.
The information as of June 30, 2000 and for the three and six
months ended June 30, 2000 and 1999 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, 1999.
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.
Total comprehensive income was $49.9 million and $27.4 million
for the quarters ended June 30, 2000 and 1999, respectively, and
$76.3 million and $39.0 million for the six months ended June 30,
2000 and 1999, respectively. Other comprehensive income (loss)
was $1.5 million and $(6.8) million for the quarters ended June
30, 2000 and 1999, respectively, and $0.4 million and $1.1
million for the six months ended June 30, 2000 and 1999,
respectively.
Supplemental Disclosures of Cash Flow Information
Noncash Investing and Financing Six months
Activities (In millions) ended June 30,
2000 1999
_______________________________________________________________
Tax benefit for stock option
and stock purchase plan $13.6 $ 4.6
Conversion of 5% and 5 1/4% Debentures
into ALZA common stock 0.1 0.2
Reclassification
Certain amounts in the prior year's financial statements
have been reclassified to conform to the 2000 presentation.
These reclassifications had no impact on previously reported
results of operations or stockholder's equity.
New Accounting Standards
In July 1999, the Financial Accounting Standards Board
("FASB") announced the delay of the effective date of Statement
of Financial Accounting Standards 133, "Accounting for Derivative
Instruments and Hedging Activities," ("SFAS 133") to the first
quarter of 2001. SFAS 133 establishes accounting and reporting
standards for derivative instruments, including certain
derivative instruments embedded in other contracts, and for
hedging activities. It requires companies to recognize all
derivatives as either assets or liabilities on the balance sheet
and measure those instruments at fair value. Gains or losses
resulting from changes in the values of those derivatives would
be accounted for depending on the use of the derivative and
whether it qualifies for hedge accounting under SFAS 133. The
impact of SFAS 133 on ALZA's financial position and results of
operations is not expected to be material.
In December 1999, the Securities and Exchange Commission
("SEC") issued Staff Accounting Bulletin No. 101, "Revenue
Recognition in Financial Statements" ("SAB 101"). SAB 101
summarizes the SEC's views in applying generally accepted
accounting principles to revenue recognition in financial
statements, and is required to be implemented by the fourth
quarter of 2000. ALZA is evaluating SAB 101's potential future
impact on ALZA's financial position and results of operations
with respect to upfront fees and milestone payments earned by
ALZA under distribution agreements, agreements with client
companies and certain other agreements. ALZA continues to
recognize fees in accordance with its historical revenue
recognition policy while it evaluates the impact of SAB 101. It
is possible that, under SAB 101, certain of these fees, including
the $15.0 million upfront fee from Bayer Corporation ("Bayer") as
described in Note 3, would be required to be deferred and
recognized as revenue over future periods rather than immediately
on a one-time basis.
In March 2000, the FASB issued Interpretation No. 44
"Accounting for Certain Transactions involving Stock Compensation-
an Interpretation of Accounting Principles Board (APB) Opinion
No. 25" ("FIN 44"). FIN 44 clarifies the application of APB
Opinion No. 25. FIN 44 was effective July 1, 2000. AlZA believes
that adoption of FIN 44 will not have a material effect on its
financial position or results of operations.
NOTE 2. EARNINGS 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 Six Months Ended
(In millions, except June 30, June 30,
per share amounts) 2000 1999 2000 1999
__________________________________________________________________
NUMERATOR:
Basic
Net income $ 48.4 $ 34.2 $75.9 $ 37.9
==================================================================
Diluted
Net income $ 48.4 $ 34.2 $75.9 $ 37.9
Adjustments, net of tax:
Interest on 5 1/4% and 5%
Debentures 8.6 3.8 17.1 -
__________________________________________________________________
Adjusted net income $ 57.0 $ 38.0 $93.0 $ 37.9
==================================================================
DENOMINATOR:
Basic
Weighted average shares 102.8 100.7 102.4 100.5
==================================================================
Diluted
Weighted average shares 103.0 101.0 102.7 100.8
Effect of dilutive
securities:
Employee stock options 2.2 1.6 1.7 2.1
5% Debentures 12.2 - 12.3 -
5 1/4% Debentures 13.0 12.3 13.0 -
_________________________________________________________________
Weighted average shares
and assumed conversions 130.4 114.9 129.7 102.9
==================================================================
Basic earnings per share $ 0.47 $ 0.34 $0.74 $ 0.38
==================================================================
Diluted earnings per share $ 0.44 $ 0.33 $0.72 $ 0.37
==================================================================
Options to purchase 1.3 million and 2.9 million shares of
common stock were excluded from the diluted earnings per share
calculation for the quarter and six months ended June 30, 2000,
respectively, compared to options and warrants to purchase 3.5
million and 3.0 million shares of common stock that were excluded
for the quarter and six months ended June 30, 1999, respectively,
because the exercise price of the options (and warrants in 1999)
was greater than the average market price of the common shares
during the periods, 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") were not included in the
diluted earnings per share calculation for the quarter and six
months ended June 30, 1999, as their inclusion would have been anti-
dilutive. The 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 six months ended
June 30, 1999, 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 from Crescendo of $23.3 million for the
quarter ended June 30, 2000 and $43.4 million for the six months
ended June 30, 2000 compared with $28.5 million for the quarter
ended June 30 1999 and $51.7 million for the six months ended
June 30, 1999. If Crescendo funding were to continue at its
current rate, all Crescendo funds available for product
development would be expended by the end of 2000.
Under the Technology License Agreement between ALZA and
Crescendo, ALZA recorded technology fee revenues from Crescendo
of $1.0 million and $2.0 million for the quarter and six months
ended June 30, 2000, respectively, compared with $2.0 million and
$4.0 million for the quarter and six months ended June 30, 1999,
respectively, all in accordance with the terms of the agreement.
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 in the United States
as Ditropan XL-registered trademark-). In July 2000, Sanofi-
Synthelabo, ALZA's marketing partner for Ditropan XL in Europe,
launched Ditropan XL in the United Kingdom after receiving
regulatory approval to market the product in that country. In
consideration of the grant of the license, ALZA paid Crescendo
2.5% of net sales of the product in 1999 and will pay 3% for 2000
and 2001. Thereafter, until 15 years after the date of the first
commercial sale of the product, the percentage owed to Crescendo
will be based upon the amount of development costs for the
product that were paid by Crescendo; based upon current
information this rate is expected to be between 5.5% and 6.5%.
On March 3, 2000, the United States Food and Drug
Administration ("FDA") approved DUROS-registered trademark-
leuprolide (which ALZA has named Viadur- trademark-) for
marketing in the United States. The product is the first FDA-
approved product to incorporate ALZA's DUROS-registered trademark-
implant technology. Also on March 3, 2000, ALZA exercised its
option to obtain a worldwide license to DUROS leuprolide from
Crescendo. Under the terms of the license agreement between
Crescendo and ALZA, Crescendo will receive payments from ALZA
based on worldwide net sales of the product. For the first
three years after launch the rates will be 2.5%, 3.0% and 3.0% of
net sales, respectively; thereafter the rate is expected to be
between 9.0% and 9.5%.
In April 2000, ALZA entered into a commercialization
agreement with Bayer for Viadur. Under the terms of the
agreement, Bayer will have the commercial rights to Viadur in the
United States through 2015. ALZA received a $15.0 million
upfront payment in the second quarter of 2000, and will receive
certain milestone payments. ALZA is also receiving quarterly
manufacturing, patent and trademark payments beginning in the
second quarter of 2000 and ending in the third quarter of 2001.
Following the launch of Viadur, ALZA will receive royalty
payments based on net sales of the product, as well as milestone
payments when the product achieves specified sales levels. ALZA
will manufacture Viadur for Bayer, for which ALZA will receive a
negotiated supply price. ALZA retains the right to buy back the
United States commercialization rights at the end of 2008, 2010
or 2012, in exchange for specified payments.
NOTE 4. MERGER-RELATED AND OTHER CHARGES
On March 16, 1999, ALZA completed a merger with SEQUUS
Pharmaceuticals, Inc. ("SEQUUS") by acquiring all of SEQUUS'
outstanding stock in a tax-free, stock-for-stock transaction. 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 and
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 accrual for merger-
related costs through the six months ended June 30, 2000:
Merger- Balance
related Utilized/ at June 30,
(In millions) costs Adjusted 2000
_________________________________________________________________
Merger transaction costs $ 13.2 $ 13.2 $ -
Exit costs 14.3 13.4 0.9
Employee severance 5.1 5.1 -
_________________________________________________________________
Total $ 32.6 $ 31.7 $ 0.9
=================================================================
As a result of the activities related to the termination of
a merger agreement with Abbott Laboratories, Inc. ("Abbott")
during 1999, ALZA incurred $13.4 million in merger-related costs.
These costs included merger transaction costs, which consisted
primarily of fees for investment bankers, attorneys and
accountants, filing fees, financial printing costs, and other
merger-related costs. The following table shows the details of
the accrual for costs related to the terminated merger through
the six months ended June 30, 2000:
Merger- Balance
related at June 30,
(In millions) costs Utilized 2000
_________________________________________________________________
Transaction costs $ 9.8 $ 9.5 $ 0.3
Other merger-related costs 3.6 3.6 -
_________________________________________________________________
Total $ 13.4 $ 13.1 $ 0.3
=================================================================
NOTE 5. SEGMENT REPORTING
ALZA has two operating segments: ALZA Pharmaceuticals, which
includes sales of products directly to the pharmaceutical
marketplace, research and development for products marketed by,
and potential products to be marketed by, ALZA (including
revenues and expenses relating to products under development with
Crescendo) and certain co-promotion revenues for products co-
promoted by ALZA; and ALZA Technologies, which includes research,
development and manufacturing for client companies and ALZA
Pharmaceuticals, and royalties and fees resulting from sales by
ALZA's client companies of products developed under joint
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.
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
sales and development revenues based upon negotiated prices.
ALZA's reportable segments are strategic 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 in ALZA
Technologies. Additionally, ALZA Pharmaceuticals develops
products for commercialization by ALZA, while ALZA Technologies
develops products for commercialization by other companies and
ALZA Pharmaceuticals.
For the current year segment presentation, certain research
and development expenses previously recorded in the ALZA
Technologies segment and charged to ALZA Pharmaceuticals were
moved to the ALZA Pharmaceuticals segment, as they were incurred
directly by ALZA Pharmaceuticals departments. Under the prior
period's segment presentation, intersegment revenues for ALZA
Technologies for the quarter and six months ended June 30, 2000
would have been $23.3 million and $43.4 million instead of $13.2
million and $24.7 million under the current segment presentation.
Certain prior year amounts have been reclassified to conform
to the current segment presentation. These amounts relate to the
cost of sales of in-licensed products marketed by ALZA
Pharmaceuticals, which under the current presentation are
recorded in ALZA Technologies and sold to ALZA Pharmaceuticals at
an intersegment transfer price.
The following tables contain information about segment
operating income (loss) for the quarter and six months ended June
30, 2000 and 1999.
Quarter ended Six Months ended
June 30, June 30,
(In millions) 2000 1999 2000 1999
________________________________________________________________
Revenues from external customers
Net sales
ALZA Pharmaceuticals $ 100.0 $ 68.8 $ 179.8 $136.7
ALZA Technologies 34.6 34.4 63.6 62.7
Royalties, fees and other
ALZA Pharmaceuticals 4.0 3.2 6.4 6.3
ALZA Technologies 80.0 51.2 143.3 106.6
Other 3.2 0.4 4.6 0.8
Research and development
ALZA Pharmaceuticals 23.3 28.5 43.4 51.7
ALZA Technologies 8.7 8.7 14.0 15.9
________________________________________________________________
Total $ 253.8 $ 195.2 $ 455.1 $380.7
================================================================
Intersegment revenues
Net sales
ALZA Pharmaceuticals $ - $ - $ - $ -
ALZA Technologies 9.8 9.2 19.7 16.0
Research and development
ALZA Pharmaceuticals 0.3 - 0.9 -
ALZA Technologies 13.2 28.6 24.7 51.8
________________________________________________________________
Total $ 23.3 $ 37.8 $ 45.3 $ 67.8
================================================================
Segment operating income (loss)
ALZA Pharmaceuticals $ 8.2 $ 2.8 $ 13.5 $ 6.9
ALZA Technologies 78.2 52.0 133.6 105.9
Other (8.1) (8.1) (19.0)1 (46.8)2
________________________________________________________________
Total $ 78.3 $ 46.7 $ 128.1 $ 66.0
================================================================
1 For the six months ended June 30, 2000, the operating loss
for Other includes $4.8 million of charges associated with the
consolidation of certain research and development facilities.
Excluding these charges, operating loss for Other would have been
$14.2 million for the six months ended June 30, 2000.
2 For the six months ended June 30, 1999, the operating loss for
Other includes merger-related expenses of $32.6 million
relating to the acquisition of SEQUUS. Excluding these
charges, operating loss for Other would have been $14.2
million for the six months ended June 30, 1999.
The following table contains a reconciliation of ALZA's
income before taxes to that reported by segment in the tables
above:
Quarter ended Six Months ended
June 30, June 30,
(In millions) 2000 1999 2000 1999
________________________________________________________________
Income (loss) before taxes
Total operating income for
reportable segments $ 78.3 $ 46.7 $ 128.1 $ 66.0
Unallocated amounts:
Interest and other income 7.2 18.4 12.6 23.4
Interest expense (15.3) (14.8) (30.7) (29.7)
________________________________________________________________
Income before income
taxes $ 70.2 $ 50.3 $ 110.0 $ 59.7
================================================================
NOTE 6. SUBSEQUENT EVENTS
On July 19, 2000, ALZA called for the redemption of its
outstanding 5% Debentures on August 18, 2000. The aggregate
principal amount of the outstanding debentures at July 19, 2000
was $493 million. The 5% Debentures are to be redeemed, pursuant
to the terms of the indenture, at a price of $1,021.43 per $1,000
principal amount of debentures, plus interest accrued for the
period from May 1, 2000 to, but not including, the redemption
date, for a total redemption price of $1,036.29 per $1,000
principal amount of debentures. The holders of the 5% Debentures
also have the option to convert their debentures into shares of
ALZA common stock at a conversion price of $38.19 per share, or
approximately 26.18 shares per $1,000 principal amount of
debentures, on or before the redemption date. If all holders of
the 5% Debentures that were outstanding at July 19, 2000, elected
to convert their debentures into shares of ALZA common stock, the
aggregate shares issued would be approximately 12.9 million.
On July 28, 2000, ALZA completed a private offering of 3%
zero coupon convertible subordinated debentures due July 28, 2020
(the "3% Debentures"), which were issued at a price of $551.26
per $1,000 principal amount at maturity. The 3% Debentures have
a total principal amount at maturity of $1.09 billion, with a
yield to maturity of 3% per annum, computed on a semiannual bond
equivalent basis. There are no periodic interest payments. The
offering resulted in approximately $587 million of net proceeds
to ALZA. The 3% Debentures are convertible, at the option of the
holder, at any time prior to maturity, unless previously redeemed
or repurchased, into 7.0135 shares of ALZA common stock per
$1,000 principal amount at maturity (equivalent at issuance to a
conversion price of $78.60 per share), subject to certain anti-
dilution adjustments. At the option of the holder, the 3%
Debentures will be repurchased by ALZA on July 28, 2003, 2008 or
2013, at a purchase price equal to the issue price plus accreted
original issue discount to such purchase date. ALZA, at its
option, may elect to deliver either ALZA common stock or cash, or
a combination of stock and cash, in the event of repurchase of
the 3% Debentures. ALZA, at its option, may also redeem any or
all of the 3% Debentures after July 28, 2003 at the issue price
plus accreted original issue discount. The proceeds of the
offering will be used for general corporate purposes. If the
holders of ALZA's outstanding 5% Debentures do not convert their
debentures to common stock prior to the redemption date, ALZA may
use the proceeds from the 3% Debentures to pay the redemption
price of the outstanding 5% Debentures.
On August 1, 2000, the FDA approved OROS methylphenidate
(Concerta- trademark- (methylphenidate HCl) extended-release
tablets (CII)) for marketing in the United States. Also in
August 2000, ALZA exercised its option to obtain a worldwide
license to the product from Crescendo and launched the product in
the United States. Under the terms of the license agreement
between ALZA and Crescendo, Crescendo will receive payments from
ALZA based on worldwide net sales of the product. For the first
three years the rates will be 2.5%, 3.0%, and 3.0% of net sales,
respectively; thereafter the rate is expected to be between 9.0%
and 9.5%.
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 risks 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, 1999.
RESULTS OF OPERATIONS
SUMMARY
Quarter Ended Six Months Ended
(In millions, June 30, June 30,
except per share amounts) 2000 1999 2000 1999
_________________________________________________________________
Revenues $ 253.8 $ 195.2 $ 455.1 $ 380.7
_________________________________________________________________
Operating income 78.3 46.7 128.1 66.0
_________________________________________________________________
Net income 48.4 34.2 75.9 37.9
_________________________________________________________________
Diluted earnings per share 0.44 0.33 0.72 0.37
_________________________________________________________________
ALZA's net income for the quarter ended June 30, 2000 was
$48.4 million or $0.44 per diluted share compared with net income
of $34.2 million or $0.33 per diluted share for the quarter ended
June 30, 1999. ALZA's net income for the six months ended June
30, 2000 was $75.9 million or $0.72 per diluted share compared
with $37.9 million or $0.37 per diluted share for the six months
ended June 30, 1999. Net income for the six months ended June
30, 2000 included charges of $3.3 million (net of tax effect of
$1.5 million), or $0.02 per diluted share, associated with the
consolidation of certain research and development facilities. Net
income for the six months ended June 30, 1999 included charges
related to the SEQUUS merger of $24.8 million (net of tax effect
of $7.8 million), or $0.24 per diluted share. Excluding these
charges, net income for the six months ended June 30, 2000 and
1999 were $79.2 million or $0.74 per diluted share and $62.7
million or $0.61 per diluted share, respectively. The increase in
net income for the quarter and six months ended June 30, 2000
compared to the same periods in 1999 resulted primarily from the
following:
- Net sales increased 31% to $134.6 million for the quarter
ended June 30, 2000 from $103.2 million for the quarter
ended June 30, 1999, and increased 22% to $243.4 million
for the six months ended June 30, 2000 from $199.4
million for the six months ended June 30, 1999. The
increase in net sales resulted primarily from a 45%
increase in net sales of ALZA-marketed products to $100.0
million for the quarter ended June 30, 2000 from $68.8
million for the quarter ended June 30, 1999, and a 32%
increase to $179.8 million for the six months ended June
30, 2000 from $136.7 million for the six months ended
June 30, 1999.
- Gross margin increased to 69% for the quarter ended June
30, 2000 from 61% for the quarter ended June 30, 1999,
and increased to 69% for the six months ended June 30,
2000 from 63% for the six months ended June 30, 1999.
- Royalties, fees and other revenues increased 58% to $87.2
million for the quarter ended June 30, 2000 from $54.8
million for the quarter ended June 30, 1999, and
increased 36% to $154.3 million for the six months ended
June 30, 2000 from $113.7 million for the six months
ended June 30, 1999.
Substantially offsetting these contributions to net income
for the quarter and six months ended June 30, 2000 were the
following:
- Research and development revenues decreased 14% to $32.0
million for the quarter ended June 30, 2000 from $37.2
million for the quarter ended June 30, 1999, and decreased
15% to $57.4 million for the six months ended June 30,
2000 from $67.6 million for the six months ended June 30,
1999.
- Selling, general and administrative expenses increased 42%
to $85.6 million for the quarter ended June 30, 2000 from
$60.4 million for the quarter ended June 30, 1999, and
increased 32% to $152.8 million for the six months ended
June 30, 2000, excluding the charges described above, from
$115.6 million for the six months ended June 30, 1999,
excluding the charges described above.
- Interest and other income decreased substantially to $7.2
million for the quarter ended June 30, 2000 from $18.4
million for the quarter ended June 30, 1999, and decreased
to $12.6 million for the six months ended June 30, 2000
compared with $23.4 million for the six months ended June
30, 1999.
OPERATING SEGMENTS
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 on ALZA's drug delivery
technologies and products for ALZA Pharmaceuticals, 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.
Quarter ended Six Months ended
OPERATING SEGMENT SUMMARY June 30, June 30,
(In millions) 2000 1999 2000 1999
_________________________________________________________________
Revenues
ALZA PHARMACEUTICALS $ 127.6 $ 100.5 $ 230.5 $194.7
ALZA TECHNOLOGIES 146.3 132.1 265.3 253.0
OTHER 3.2 0.4 4.6 0.8
_________________________________________________________________
Total segment revenues 277.1 233.0 500.4 448.5
Intersegment elimination (23.3) (37.8) (45.3) (67.8)
_________________________________________________________________
Total revenues $ 253.8 $ 195.2 $ 455.1 $380.7
_________________________________________________________________
Operating income (loss)
ALZA PHARMACEUTICALS $ 8.2 $ 2.8 $ 13.5 $ 6.9
ALZA TECHNOLOGIES 78.2 52.0 133.6 105.9
OTHER (8.1) (8.1) (19.0)1 (46.8)2
_________________________________________________________________
Total operating income $ 78.3 $ 46.7 $ 128.1 $ 66.0
_________________________________________________________________
1 For the six months ended June 30, 2000, the operating loss for
Other includes $4.8 million of charges associated with the
consolidation of certain research and development facilities.
Excluding these charges, operating loss for Other would have
been $14.2 million for the six months ended June 30, 2000.
2 For the six months ended June 30, 1999, the operating loss
for Other includes merger-related expenses of $32.6 million
relating to the acquisition of SEQUUS. Excluding these charges,
operating loss for Other would have been $14.2 million for the
six months ended June 30, 1999.
ALZA PHARMACEUTICALS
Operating income increased substantially for the quarter and
six months ended June 30, 2000 compared to the same periods in
1999, primarily due to a 27% and 18% increase in revenues for the
quarter and six months ended June 30, 2000, respectively,
compared to the same periods in 1999, and a 22% and 23% decrease
in research and development expenses for the quarter and six
months ended June 30, 2000, respectively, compared to the same
periods in 1999. The increase in revenues was primarily due to a
45% and 32% increase in net sales of ALZA-marketed products for
the quarter and six months ended June 30, 2000, respectively,
compared to the same periods in 1999, partially offset by a 17%
and 14% decrease in research and development revenues for the
quarter and six months ended June 30, 2000, respectively,
compared to the same periods in 1999. Also offsetting the
increase in revenues and decrease in research and development
expenses was a 45% and 35% increase in sales, marketing and
product amortization expenses for the quarter and six months
ended June 30, 2000, respectively, compared to the same periods
in 1999.
ALZA TECHNOLOGIES
Operating income increased 51% and 26% for the quarter and
six months ended June 30, 2000, respectively, compared to the
same periods in 1999, primarily due to a 56% and 34% increase in
revenues from royalties, fees and other for the quarter and six
months ended June 30, 2000, respectively, compared to the same
periods in 1999, and a 17% and 14% decrease in research and
development expenses for the quarter and six months ended June
30, 2000, compared to the same periods in 1999. Partially
offsetting the increase in revenues from royalties, fees and
other and the decrease in research and development expenses was a
54% and 52% decrease in intersegment research and development
revenues for the quarter and six months ended June 30, 2000,
respectively, compared to the same periods in 1999.
OTHER
Operating loss for the quarter and six months ended June 30,
2000 remained constant compared to the same periods for 1999, in
both six month periods excluding certain charges described above.
NET SALES
Net Sales Quarter Ended Six Months Ended
June 30, June 30,
(Dollars in millions) 2000 1999 2000 1999
_________________________________________________________________
ALZA PHARMACEUTICALS
Ditropan XL-registered
trademark- $ 45.7 $ 14.4 $ 78.5 $ 36.4
Doxil-registered trademark-
/Caelyx-registered
trademark- 15.1 14.0 28.1 28.3
Ethyol-registered trademark- 7.6 8.5 21.4 17.1
Elmiron-registered trademark- 8.8 7.7 13.8 12.6
Mycelex-registered trademark-
Troche 10.0 7.7 13.6 12.7
Testoderm-registered
trademark- TTS line 6.1 5.2 10.6 9.7
Other 6.7 11.3 13.8 19.9
__________________________________________________________________
Total 100.0 68.8 179.8 136.7
__________________________________________________________________
ALZA TECHNOLOGIES
Contract manufacturing 34.6 34.4 63.6 62.7
Intersegment 9.8 9.2 19.7 16.0
__________________________________________________________________
Total 44.4 43.6 83.3 78.7
__________________________________________________________________
Intersegment eliminations (9.8) (9.2) (19.7) (16.0)
___________________________________________________________________
Total net sales $134.6 $103.2 $243.4 $199.4
___________________________________________________________________
Total net sales as a percentage
of total revenues 53% 53% 53% 52%
___________________________________________________________________
ALZA PHARMACEUTICALS
Included in net sales of ALZA Pharmaceuticals 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
(and to a limited extent, direct sales by ALZA of Amphocil-
registered trademark- (lipid-based amphotericin B) in the United
Kingdom). Net sales of ALZA-marketed products increased 45% and
32% for the quarter and six months ended June 30, 2000,
respectively, compared to the same periods in 1999. This increase
in ALZA Pharmaceuticals' net sales can be primarily attributed to a
substantial increase in sales of Ditropan XL for the quarter and
six months ended June 30, 2000, compared to the same periods in
1999.
Net sales of ALZA-marketed products can be expected to vary
significantly from year to year, particularly in the first years
after launch of a new product. Ditropan XL was launched in the
first quarter of 1999, and Doxil-registered trademark-
(doxorubicin HCl liposome injection), Ethyol-registered trademark-
(amifostine), Elmiron-registered trademark- (pentosan polysulfate
sodium) and Testoderm-registered trademark- TTS (Testosterone
Transdermal System) were cleared for marketing during the past
few years. In June 1999, the FDA approved new indications for
Ethyol and Doxil. In July 2000, Sanofi-Synthelabo, ALZA's
marketing partner for Ditropan XL in Europe, launched Ditropan XL
in the United Kingdom after receiving regulatory approval to
market the product in that country. In August 2000, ALZA launched
Concerta, upon receiving FDA approval to market Concerta in the
United States. Wholesaler stocking patterns, managed care and
formulary acceptance, the introduction of competitive products,
and acceptance by patients and physicians will also affect future
sales of ALZA's products.
ALZA TECHNOLOGIES
Net sales include sales generated from contract
manufacturing activities for ALZA's client companies and
manufacturing for ALZA Pharmaceuticals. Net sales from contract
manufacturing for the quarter and six months ended June 30, 2000
remained relatively constant compared to the same periods in
1999, as ALZA experienced increases in shipments of Duragesic-
registered trademark- (fentanyl) to Janssen Pharmaceutica, Inc.
(together with its affiliates, "Janssen") and Nicoderm-registered
trademark- and NicoDerm-registered trademark- CQ-registered
trademark- (nicotine transdermal system) to Aventis S.A.
("Aventis") and SmithKline Beecham p.l.c.("SB"), which were
offset by a decline in shipments of Catapres-TTS-registered
trademark- (clonidine) to Boehringer Ingelheim Pharmaceuticals,
Inc. and of Glucotrol XL-registered trademark- (glipizide) to
Pfizer Inc. ("Pfizer").
The timing and quantities of orders for products marketed by
client companies are not within ALZA's control. Net sales by ALZA
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
Gross Margin
Quarter Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
__________________________________________________________________
ALZA PHARMACEUTICALS1 79% 80% 80% 81%
ALZA TECHNOLOGIES 1 30% 18% 26% 18%
__________________________________________________________________
Gross margin as percentage
of total net sales 2 69% 61% 69% 63%
__________________________________________________________________
1 Includes intersegment revenues or expenses.
2 After intersegment eliminations.
The increase in total gross margin for the quarter and six
months ended June 30, 2000 compared to the same periods for 1999
was due to a relative increase in shipments of higher-margin
products by ALZA Technologies to client companies, as well as an
increase in ALZA Pharmaceuticals sales as a percentage of total
sales.
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 Technologies' gross margin on its contract
manufacturing sales is 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 generally 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.
ROYALTIES, FEES AND OTHER REVENUES
Royalties, fees and other revenues consist largely of
royalties paid by client companies on products developed under
joint development and commercialization agreements with ALZA and
marketed by the companies. Fee revenues consist of upfront,
milestone and other one-time, special or infrequent payments made
under these joint development agreements, or by distributors who
acquire rights to market ALZA products, and co-promotion fees.
Royalties, Fees and Other Revenues
Quarter Ended Six Months Ended
June 30, June 30,
(Dollars in millions) 2000 1999 2000 1999
__________________________________________________________________
ALZA PHARMACEUTICALS $ 4.0 $ 3.2 $ 6.4 $ 6.3
ALZA TECHNOLOGIES 80.0 51.2 143.3 106.6
OTHER 3.2 0.4 4.6 0.8
__________________________________________________________________
Total royalties, fees and
other revenues $ 87.2 $ 54.8 $154.3 $113.7
__________________________________________________________________
Percentage of total revenues 34% 28% 34% 30%
__________________________________________________________________
ALZA PHARMACEUTICALS
For the quarter and six months ended June 30, 2000, fee
revenues for ALZA Pharmaceuticals included technology fees from
Crescendo of $1.0 million and $2.0 million, respectively,
compared to $2.0 million and $4.0 million for the same periods in
1999, as provided in the agreements between ALZA and Crescendo.
Fee revenues from Crescendo will end in the third quarter of
2000. In addition, ALZA Pharmaceuticals' royalties, fees and
other revenues included co-promotion fee revenues of $1.7 million
and $2.9 million for the quarter and six months ended June 30,
2000, respectively, compared to $1.2 million and $2.2 million for
the same periods in 1999.
ALZA TECHNOLOGIES
Royalties, fees and other revenues increased 56% and 34% for
the quarter and six months ended June 30, 2000, respectively,
compared to the same periods in 1999. The increase in royalties,
fees and other revenues was primarily due to a $15.0 million
upfront fee from Bayer in the second quarter for
commercialization rights to Viadur. In addition, royalties from
product sales of Duragesic increased 41% and 36% for the quarter
and six months ended June 30, 2000, respectively, compared to the
same periods in 1999.
In December 1999, the Securities and Exchange Commission
("SEC") issued Staff Accounting Bulletin No. 101, "Revenue
Recognition in Financial Statements" ("SAB 101"). SAB 101
summarizes the SEC's views in applying generally accepted
accounting principles to revenue recognition in financial
statements, and is required to be implemented by the fourth
quarter of 2000. ALZA is evaluating SAB 101's potential future
impact on ALZA's financial position and results of operations
with respect to upfront fees and milestone payments earned by
ALZA under distribution agreements, agreements with client
companies and certain other agreements. ALZA continues to
recognize fees in accordance with its historical revenue
recognition policy while it evaluates the impact of SAB 101. It
is possible that under SAB 101, certain of these fees, including
the $15.0 million upfront fee from Bayer, would be required to be
deferred and recognized as revenue over future periods rather
than immediately on a one-time basis.
Sales of Procardia XL-registered trademark- (nifedipine),
as reported by Pfizer, decreased 33% and 27% for the quarter and
six months ended June 30, 2000, respectively, compared to the
same periods in 1999. Several companies have filed Abbreviated
New Drug Applications ("ANDAs") with the FDA requesting clearance
to market generic sustained release nifedipine products which are
asserted to be bioequivalent to Procardia XL, and three companies
have received full FDA approval of their ANDAs. Pfizer has filed
various suits against certain ANDA applicants for infringement of
patent rights relating to the nifedipine active drug substance in
Procardia XL. In March 2000, Pfizer entered into a settlement
agreement with Mylan Laboratories Inc. ("Mylan"), the first
applicant for a generic version of Procardia XL. The settlement
resolved the litigation pending between the parties, and Mylan
announced that it would commercialize a generic version of
Procardia XL to be supplied by Pfizer and incorporating ALZA's
OROS technology. Under its agreement with Pfizer, ALZA will
receive royalties on such products. 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 generic
sustained-release nifedipine products.
OTHER
Other revenues increased substantially for the quarter and
six months ended June 30, 2000 compared to the same periods in
1999, primarily due to rental income from facilities that ALZA
leased out beginning in the second half of 1999 and first half of
2000.
RESEARCH AND DEVELOPMENT
ALZA's research and development revenues generally represent
reimbursement of costs, including a portion of general and
administrative expenses, by clients (including Crescendo) for the
development of products. Therefore, product development
activities do not contribute significantly to ALZA's operating
results.
Research and Development Revenues
Quarter Ended Six Months Ended
June 30, June 30,
(Dollars in millions) 2000 1999 2000 1999
__________________________________________________________________
ALZA PHARMACEUTICALS
Crescendo $ 23.3 $ 28.5 $43.4 $ 51.7
Intersegment 0.3 - 0.9 -
__________________________________________________________________
Total 23.6 28.5 44.3 51.7
__________________________________________________________________
ALZA TECHNOLOGIES
Other clients 8.7 8.7 14.0 15.9
Intersegment 13.2 28.6 24.7 51.8
__________________________________________________________________
Total 21.9 37.3 38.7 67.7
__________________________________________________________________
Intersegment elimination (13.5) (28.6) (25.6) (51.8)
__________________________________________________________________
Total research and
development revenues $ 32.0 $ 37.2 $57.4 $ 67.6
__________________________________________________________________
Percentage of total revenues 13% 19% 13% 18%
__________________________________________________________________
ALZA PHARMACEUTICALS
ALZA Pharmaceuticals derives research and development
revenues from Crescendo. Revenues from Crescendo are offset by
intersegment charges from ALZA Technologies, under the prior
period's segment presentation, and are partially offset under the
current year segment presentation. Intersegment charges from ALZA
Technologies are for research and development expenses incurred
on behalf of ALZA Pharmaceuticals related to products under
development for marketing by ALZA Pharmaceuticals. If Crescendo
funding were to continue at its current rate, all Crescendo funds
available for product development would be expended by the end of
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 (marketed in the United States as Ditropan XL). Under
the terms of the license agreement, ALZA makes payments to
Crescendo based upon worldwide sales of the product. In July
2000, Sanofi-Synthelabo, ALZA's marketing partner for Ditropan XL
in Europe, launched Ditropan XL in the United Kingdom after
receiving regulatory approval to market the product in that
country. In consideration of the grant of the license, ALZA paid
Crescendo 2.5% of net sales of the product in 1999 and will pay
3% for 2000 and 2001. Thereafter, until 15 years after the date
of the first commercial sale of the product, the percentage of
net sales owed to Crescendo will be based upon the amount of
development costs for the product that were paid by Crescendo;
based upon current information, this rate is expected to be
between 5.5% and 6.5%.
On March 3, 2000, the FDA approved DUROS leuprolide (which
ALZA has named Viadur) for marketing in the United States. The
product is the first FDA-approved product to incorporate ALZA's
DUROS implant technology. Also on March 3, 2000, ALZA exercised
its option to obtain a worldwide license to DUROS leuprolide from
Crescendo. Under the terms of the license agreement between
Crescendo and ALZA, Crescendo will receive payments from ALZA
based on worldwide net sales of the product. For the first three
years after launch the rates will be 2.5%, 3.0% and 3.0% of net
sales, respectively; thereafter the rate is expected to be
between 9.0% and 9.5%.
In April 2000, ALZA entered into a commercialization
agreement with Bayer for Viadur. Under the terms of the
agreement, Bayer will have the commercial rights to Viadur in the
United States through 2015. ALZA received a $15.0 million
upfront payment in the second quarter of 2000, and will receive
certain milestone payments. ALZA is also receiving quarterly
manufacturing, patent and trademark payments beginning in the
second quarter of 2000 and ending in the third quarter of 2001.
Following the launch of Viadur, ALZA will receive royalty
payments based on net sales of the product, as well as milestone
payments when the product achieves specified sales levels. ALZA
will manufacture Viadur for Bayer, for which ALZA will receive a
negotiated supply price. ALZA retains the right to buy back the
United States commercialization rights at the end of 2008, 2010
or 2012, in exchange for specified payments.
On August 1, 2000, the FDA approved Concerta for marketing
in the United States. Also in August 2000, ALZA exercised its
option to obtain a worldwide license to the product from
Crescendo and launched the product in the United States. Under
the terms of the license agreement between ALZA and Crescendo,
Crescendo will receive payments from ALZA based on worldwide net
sales of the product. For the first three years the rates will
be 2.5%, 3.0%, and 3.0% of net sales, respectively; thereafter
the rate is expected to be between 9.0% and 9.5%.
ALZA TECHNOLOGIES
Research and development revenues from other clients
remained constant for the quarter ended June 30, 2000 compared to
the same period in 1999. Research and development revenues
decreased 12% for the six months ended June 30, 2000 compared to
the same period in 1999, reflecting a lower level of product
development activities under agreements with client companies.
Several new technology agreements have been signed since the
beginning of 2000, which may increase the level of product
development activities in the future. Revenues from product
development activities vary from quarter to quarter depending
upon the mix of projects underway and the phase of development of
each project. The decrease in the intersegment revenues is due
to a decline in research and development activities related to
Crescendo products as well as the change in the current period's
segment presentation for research and development expenses. In
the current year segment presentation, certain research and
development expenses previously recorded in the ALZA Technologies
segment and charged to ALZA Pharmaceuticals were moved to the
ALZA Pharmaceuticals segment, as they were incurred directly by
ALZA Pharmaceuticals departments. Under the prior period's
segment presentation, intersegment revenues for ALZA Technologies
for the quarter and six months ended June 30, 2000 would have
been $23.3 million and $43.4 million, respectively, instead of
$13.2 million and $24.7 million under the current segment
presentation.
Research and Development Expenses
Quarter Ended Six Months Ended
June 30, June 30,
(Dollars in millions) 2000 1999 2000 1999
__________________________________________________________________
ALZA PHARMACEUTICALS
Intersegment $ 13.2 $ 28.6 $24.7 $ 51.8
Product development
expense 13.5 5.9 26.6 14.6
__________________________________________________________________
Total 26.7 34.5 51.3 66.6
__________________________________________________________________
ALZA TECHNOLOGIES
Intersegment 0.3 - 0.9 -
Product development
expense 34.4 41.9 66.1 77.3
__________________________________________________________________
Total 34.7 41.9 67.0 77.3
__________________________________________________________________
Intersegment elimination (13.5) (28.6) (25.6) (51.8)
__________________________________________________________________
Total research and development
expenses $ 47.9 $ 47.8 $92.7 $ 91.9
__________________________________________________________________
Percentage of total revenues 19% 25% 20% 24%
__________________________________________________________________
ALZA PHARMACEUTICALS
ALZA Pharmaceuticals engages ALZA Technologies to provide
research and development services, which are charged under the
same formula ALZA charges client companies. Total research and
development expenses decreased 23% for the quarter and six months
ended June 30, 2000 compared to the same periods in 1999,
primarily due to a decline in research and development activities
related to Crescendo products as well the change in the current
period's segment presentation for research and development
expenses. In the current year segment presentation, certain
research and development expenses, including expenses of clinical
studies, previously recorded in the ALZA Technologies segment and
charged to ALZA Pharmaceuticals were moved to the ALZA
Pharmaceuticals segment, as they were incurred directly by ALZA
Pharmaceuticals departments. Under the prior period's segment
presentation, intersegment expenses for the quarter and six
months ended June 30, 2000 would have been $23.3 million and
$43.4 million, respectively. Product development expense under
the prior period's segment presentation for the quarter and six
months ended June 30, 2000 would have been $9.2 million and $18.4
million, respectively.
ALZA TECHNOLOGIES
Research and development expenses decreased 17% and 14% for
the quarter and six months ended June 30, 2000, respectively,
compared to same periods in 1999, reflecting a decrease in
product development activities for ALZA Pharmaceuticals (and
Crescendo) and under agreements with client companies. In the
current year segment presentation, certain research and
development expenses previously recorded in the ALZA Technologies
segment and charged to ALZA Pharmaceuticals were moved to the
ALZA Pharmaceuticals segment, as they were incurred directly by
ALZA Pharmaceuticals departments. Under the prior period's
segment presentation, product development expense for the quarter
and six months ended June 30, 2000 would have been $39.8 million
and $75.4 million, respectively.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
Selling, General and Administrative Expenses
Quarter Ended Six Months Ended
June 30, June 30,
(Dollars in millions) 2000 1999 2000 1999
__________________________________________________________________
ALZA PHARMACEUTICALS
Sales and marketing
expenses $ 68.6 $ 45.8 $122.2 $ 88.2
Amortization of product
acquisition payments 3.3 3.7 7.1 7.7
__________________________________________________________________
Total 71.9 49.5 129.3 95.9
__________________________________________________________________
ALZA TECHNOLOGIES
Amortization of product
acquisition payments 2.3 2.3 4.6 4.6
__________________________________________________________________
OTHER
General and administrative
expenses 11.4 8.6 23.7(1) 15.1
__________________________________________________________________
Total selling, general
administrative expenses $ 85.6 $ 60.4 $157.6 $115.6
__________________________________________________________________
Total selling, general and
administrative expenses as a
percentage of total revenues 34% 31% 35% 30%
__________________________________________________________________
(1) For the six months ended June 30, 2000, general and
administrative expenses for Other includes $4.8 million of
charges associated with the consolidation of certain research
and development facilities. Excluding these charges, general
and administrative expenses for Other would have been
$18.9 million for the six months ended June 30, 2000.
ALZA PHARMACEUTICALS
Total sales, marketing and product amortization expenses
increased 45% and 35% for the quarter and six months ended June
30, 2000, respectively, compared to the same periods in 1999, as
a result of the significant increase in sales and marketing
expenses for ALZA's expanded product portfolio and commercial
organization, as well as the increase in expenses associated with
the promotion of Ditropan XL and Doxil. During the quarter and
six months ended June 30, 2000, ALZA increased the size of its
urology, primary care and oncology sales forces, and accelerated
certain spending in preparation for the anticipated launch of
Concerta.
In April 2000, ALZA entered into an agreement with McNeil
Consumer Healthcare ("McNeil"), a Johnson and Johnson company, to
co-promote Concerta in the United States. ALZA and McNeil will
deploy a combined sales force of over 400 sales professionals to
support Concerta, including over 300 sales professionals from
McNeil. McNeil will receive payments based on sales calls made
and based on sales of Concerta above certain levels.
OTHER
General and administrative expenses increased slightly for
the quarter and six months ended June 30, 2000, respectively,
compared to the same period in 1999, excluding the first quarter
2000 charges described above. The increase was primarily due to
an increase in corporate administrative expenses.
NET INTEREST
Quarter Ended Six Months Ended
Net Interest June 30, June 30,
(In millions) 2000 1999 2000 1999
__________________________________________________________________
Interest and other income $ (7.2) $(18.4) $(12.6) $(23.4)
Interest expense 15.3 14.8 30.7 29.7
__________________________________________________________________
Net interest and
other (income) expense 8.1 (3.6) 18.1 6.3
__________________________________________________________________
Interest and other income decreased 61% and 46% for the
quarter and six months ended June 30, 2000, respectively,
compared to the same periods in 1999, primarily due to a pretax
gain of $12.6 million on sales of real estate that were completed
during the quarter ended June 30, 1999. Interest expense was
slightly higher for the quarter and six months ended June 30,
2000 compared to the same periods for 1999, primarily due to
accreted interest on ALZA's outstanding 5 1/4% Debentures and a
decrease in capitalization of interest expense due to lower
expenditures on capital projects during the first six months of
2000.
Effective Tax Rate
For the quarter and six months ended June 30, 2000, ALZA's
combined federal and state effective income tax rate was 31%
compared to 32% for same periods in 1999, excluding the tax
benefit of $7.8 million resulting from merger-related costs of
$32.6 million. ALZA currently expects its effective income tax
rate in 2000 and 2001 to be approximately 31%. The actual
effective income tax rate will depend upon the actual level of
earnings, changes in the tax laws, and the amount of investment
and research credits available and ALZA's ability to utilize such
credits.
LIQUIDITY AND CAPITAL RESOURCES
Liquidity and Capital Resources June 30, December 31,
(In millions) 2000 1999
__________________________________________________________________
Working capital $ 406.1 $ 297.8
Cash and investments 651.7 598.9
Total assets 1,979.0 1,852.5
Long-term debt 983.1 979.0
__________________________________________________________________
Six months ended June 30,
(In millions) 2000 1999
_________________________________________________________________
Net cash provided by
operating activities $ 44.8 $ 12.7
Capital expenditures 17.7 40.8
Product acquisition payments 5.8 20.0
_________________________________________________________________
Cash flow generated by operating activities for the six
months ended June 30, 2000 was $44.8 million compared to $12.7
million (or $31.8 million excluding payments for merger-related
expenses) for the six months ended June 30, 1999. The increase
in cash flow provided by operating activities was primarily due
to higher net income of $75.9 million for the six months ended
June 30, 2000 compared with $37.9 million for the same period in
1999.
ALZA's capital spending for the six months ended June 30,
2000 was $17.7 million for additions to facilities and equipment
to support its expanding research, development and manufacturing
activities, compared to capital spending of $40.8 million for the
same period in 1999. Capital expenditures for the remainder of
2000 are expected to decrease compared to 1999 levels as a result
of the completion of the current phase of development of the
Mountain View campus into which ALZA moved during 1999.
On July 19, 2000, ALZA called for the redemption of its
outstanding 5% Debentures on August 18, 2000. The aggregate
principal amount of the outstanding debentures at July 19, 2000
was $493 million. The 5% Debentures are to be redeemed, pursuant
to the terms of the indenture, at a price of $1,021.43 per $1,000
principal amount of debentures, plus interest accrued for the
period from May 1, 2000 to, but not including, the redemption
date, for a total redemption price of $1,036.29 per $1,000
principal amount of debentures. The holders of the 5% Debentures
also have the option to convert their debentures into shares of
ALZA common stock at a conversion price of $38.19 per share, or
approximately 26.18 shares per $1,000 principal amount of
debentures, on or before the redemption date. If all holders of
the 5% Debentures that were outstanding at July 19, 2000, elected
to convert their debentures into shares of ALZA common stock, the
aggregate shares issued would be approximately 12.9 million.
On July 28, 2000, ALZA completed a private offering of 3%
zero coupon convertible subordinated debentures due July 28, 2020
(the "3% Debentures"), which were issued at a price of $551.26
per $1,000 principal amount at maturity. The 3% Debentures have
a total principal amount at maturity of $1.09 billion, with a
yield to maturity of 3% per annum, computed on a semiannual bond
equivalent basis. There are no periodic interest payments. The
offering resulted in approximately $587 million of net proceeds
to ALZA. The 3% Debentures are convertible, at the option of the
holder, at any time prior to maturity, unless previously redeemed
or repurchased, into 7.0135 shares per $1,000 principal amount at
maturity (equivalent at issuance to of ALZA common stock at a
conversion price of $78.60 per share), subject to certain anti-
dilution adjustments. At the option of the holder, the 3%
Debentures will be repurchased by ALZA on July 28, 2003, 2008 or
2013, at a purchase price equal to the issue price plus accreted
original issue discount to such purchase date. ALZA, at its
option, may elect to deliver either ALZA common stock or cash, or
a combination of stock or cash, in the event of repurchase of the
3% Debentures. ALZA, at its option, may also redeem any or all of
the 3% Debentures after July 28, 2003, at the issue price plus
accreted original issue discount. The proceeds of the offering
will be used for general corporate purposes. If the holders of
ALZA's outstanding 5% Debentures do not convert their debentures
to common stock prior to the redemption date, ALZA may use the
proceeds from the 3% Debentures to pay the redemption price of
the outstanding 5% Debentures.
ALZA believes that its existing cash and investment
balances, including the proceeds from the sale of the 3%
Debentures, are adequate to fund its cash needs for 2000 and
beyond. In addition, should the need arise, ALZA believes it
would be able to borrow additional funds (although no such
borrowing arrangements are in place) or otherwise raise
additional capital. ALZA may use its capital to acquire or
license technology or products and/or to make strategic
investments.
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, 1999.
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 or certain other commercial
arrangements. 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 $5.2
million decrease in ALZA's available-for-sale securities, based
upon a sensitivity analysis performed on ALZA's financial
position at June 30, 2000. However, actual results may differ
materially.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Product liability suits have been filed against ALZA from
time to time relating to various products, and a number of suits
have been filed against Janssen and ALZA relating to the
Duragesic product. Janssen is managing the defense of the
Duragesic product suits in consultation with ALZA under an
agreement between the parties.
In October 1999, purported class action lawsuits were filed
against ALZA, Abbott and certain directors of each company and
such suits were consolidated as In re Abbott/ALZA Merger
Litigation in the federal court in the Northern District of
Illinois (99C6584). The suits alleged that ALZA and Abbott had
wrongfully failed to disclose certain regulatory issues regarding
Abbott's diagnostic business to ALZA stockholders prior to an
ALZA stockholders meeting in September 1999. The suits were
dismissed in December 1999. Attorneys representing the
plaintiffs in this litigation have petitioned the court for
attorneys' fees in connection with their services in this case;
ALZA and Abbott have opposed this petition.
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.
Item 4. Submission of Matters to a Vote of Security Holders
(a) The annual meeting of the stockholders of ALZA was held on
May 18, 2000.
(b) A total of 86,470,225 shares were represented at the annual
meeting. Stockholders approved the following proposals:
(i) Election of Class I Directors:
Votes For Votes Withheld
Dr. William R. Brody 85,545,557 924,668
Julian N. Stern 84,661,683 1,808,542
(ii) An automatic annual increase in the number of shares
of ALZA common stock reserved for issuance under ALZA's
Amended andRestated Employee Stock Purchase Plan. There
were 78,878,032 votes in favor, 7,130,458 votes
against andand 461,375 abstentions.
(iii) The ratification of the appointment of Ernst & Young
LLP as ALZA's independent auditors for the fiscal year
ended December 31, 2000. There were 86,010,720 votes
in favor, 156,699 votes against and 302,706 abstentions.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits:
27 Financial Data Schedule
(b) No reports on Form 8-K were filed during the quarter
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: August 11, 2000 By: /s/ E. Mario
____________________
Dr. Ernest Mario
Chairman and Chief
Executive Officer
Date: August 11, 2000 By: /s/ Matthew K. Fust
________________________
Matthew K. Fust
Senior Vice President and
Chief Financial Officer
EXHIBIT INDEX
Exhibit
27 Financial Data Schedule