FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Quarterly Report under Section 13 of the
Securities Exchange Act of 1934
Quarter ended September 30, 2000
Commission File Number 0-24320
NaPRO BIOTHERAPEUTICS, INC.
Incorporated in Delaware IRS ID No. 84-1187753
6304 Spine Road, Unit A
Boulder, CO 80301
(303) 530-3891
NaPro BioTherapeutics, Inc. (1) has filed all reports required to be filed by
Section 13 of the Securities Exchange Act of 1934 during the preceding 12
months, and (2) has been subject to such filing require ments for the past 90
days.
The number of shares outstanding of each of the issuer's classes of common stock
as of October 31, 2000:
Common Stock, $.0075 par value 24,203,189
Non-voting Common Stock, $.0075 par value 395,000
Total number of pages in document--20
<PAGE>
<TABLE>
<CAPTION>
NaPro BioTherapeutics, Inc.
Table of Contents
Page
Part I Financial Information
Consolidated Financial Statements
<S> <C>
Balance Sheet 3
Statement of Operations 5
Cash Flow Statement 6
Notes to Consolidated Financial Statements 8
Management's Discussion and Analysis of Financial Condition and Results of Operations 9
Quantitative and Qualitative Disclosures about Market Risk 15
Part II Other Information
Legal Proceedings 16
Changes in Securities 16
Defaults Upon Senior Securities 16
Submission of Matters to a Vote of Security Holders 16
Other Information 17
Exhibits and Reports on Form 8-K 17
Signatures 18
</TABLE>
2
<PAGE>
Part I. Financial Information
Item 1. Consolidated Financial Statements
<TABLE>
<CAPTION>
NaPro BioTherapeutics, Inc.
Balance Sheet
Assets
September 30, December 31,
2000 1999
------ ----
(unaudited)
Current assets:
<S> <C> <C>
Cash and cash equivalents $ 4,918,000 $ 1,937,000
Accounts receivable 2,341,000 1,416,000
Inventory:
Raw materials 1,027,000 129,000
Work-in-process 960,000 481,000
Finished goods 1,440,000 1,578,000
------------- --------------
3,427,000 2,188,000
Prepaid expense and other 432,000 153,000
-------------- --------------
Total current assets 11,118,000 5,694,000
Property and equipment, net 9,423,000 10,693,000
Inventory:
Raw materials 1,327,000 1,562,000
Work-in-process --- 892,000
------------------ --------------
1,327,000 2,454,000
Other assets 252,000 416,000
-------------- --------------
Total assets $22,120,000 $19,257,000
=========== ===========
</TABLE>
See accompanying notes.
3
<PAGE>
<TABLE>
<CAPTION>
NaPro BioTherapeutics, Inc.
Balance Sheet
Liabilities and Stockholders' Equity
September 30, December 31,
2000 1999
------ -----
(unaudited)
Current liabilities:
<S> <C> <C>
Accounts payable $ 1,943,000 $ 2,174,000
Accrued payroll and payroll taxes 943,000 557,000
Notes payable--current portion 203,000 48,000
------------ -------------
Total current liabilities 3,089,000 2,779,000
Notes payable--long term 13,968,000 4,723,000
------------ ------------
Total liabilities 17,057,000 7,502,000
Minority interest 622,000 622,000
Stockholders' equity Preferred stock, $.001 par value:
Authorized shares--2,000,000
Issued--none --- ---
Non-voting common stock, convertible on disposition
into voting common stock, $.0075 par value:
Authorized shares--1,000,000
Issued and outstanding shares--395,000 3,000 3,000
Common stock, $.0075 par value:
45,000,000 and 30,000,000 authorized at September 30, 2000 (unaudited)
and December 31, 1999, respectively 24,471,225 shares issued in 2000
(unaudited),
and 23,482,671 in 1999 184,000 176,000
Additional paid-in capital 70,312,000 65,358,000
Deficit (64,716,000) (52,620,000)
Treasury stock--405,885 shares in 2000 (unaudited),
and 539,867 shares in 1999 (1,342,000) (1,784,000)
------------ -------------
Total stockholders' equity 4,441,000 11,133,000
------------ ------------
Total liabilities and stockholders' equity $22,120,000 $ 19,257,000
============ =============
</TABLE>
See accompanying notes.
4
<PAGE>
<TABLE>
<CAPTION>
NaPro BioTherapeutics, Inc.
Statement of Operations
(Unaudited)
Quarter Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
------ ------ ------ -----
<S> <C> <C> <C> <C>
Sales $ 2,343,000 $ 2,181,000 $ 6,374,000 $ 6,168,000
Expense:
Research, development and
cost of products sold 3,571,000 3,479,000 10,197,000 9,172,000
General and administrative 2,072,000 1,974,000 5,709,000 4,436,000
Loss on retirement of assets --- --- 2,245,000 ---
------------ ------------ ------------ ------------
5,643,000 5,453,000 18,151,000 13,608,000
------------ ------------ ------------ -----------
Operating loss (3,300,000) (3,272,000) (11,777,000) (7,440,000)
License fee --- 1,300,000 --- 2,320,000
Interest income 104,000 136,000 170,000 255,000
Interest expense (216,000) (216,000) (489,000) (534,000)
------------ ------------ ------------ ------------
Loss before extraordinary
item (3,412,000) (2,052,000) (12,096,000) (5,399,000)
Extraordinary item--loss on early
extinguishment of debt --- --- --- (182,000)
------------ ------------ ------------ ------------
Net loss $(3,412,000) $(2,052,000) $(12,096,000) $ (5,581,000)
============ ============ ============ ============
Net loss attributed to common
shareholders $(3,412,000) $(3,093,000) $(12,096,000) $ (6,787,000)
============ ============ ============ ============
Basic and diluted loss per share
Loss before extraordinary
item $ (0.14) $ (0.14) $ (0.51) $ (0.33)
Extraordinary item--loss on
early extinguishment of debt --- --- ---
------------ ------------ ------------
(0.01)
Net loss $ (0.14) $ (0.14) $ (0.51) (0.34)
============ ============ ============ ============
Weighted average shares outstanding 24,059,704 22,307,471 23,502,744 19,753,939
============ ============ ============ ============
</TABLE>
See accompanying notes.
5
<PAGE>
<TABLE>
<CAPTION>
NaPro BioTherapeutics, Inc.
Cash Flow Statement
(Unaudited)
Nine Months Ended
September 30,
2000 1999
------ -----
Operating activity
<S> <C> <C>
Net loss $ (12,096,000) $(5,581,000)
Adjustments to reconcile net loss to net cash
used by operating activity:
Depreciation 1,167,000 1,174,000
Accretion of debt issue cost, warrant allocation
and conversion rights allocation 30,000 395,000
Compensation paid with common stock, options
and warrants 667,000 1,040,000
Interest expense paid with common stock --- 27,000
Loss on retirement of assets 2,245,000 ---
Loss on early extinguishment of debt --- 35,000
Changes in operating assets and liabilities:
Accounts receivable (925,000) (1,084,000)
Inventory 259,000 81,000
Prepaid expense and other assets 100,000 117,000
Accounts payable (231,000) 89,000
Accrued liabilities 386,000 163,000
Deferred revenue --- (2,910,000)
-------------- -----------
Net cash used by operating activity (8,398,000) (6,454,000)
Investing activity
Transfer of restricted cash --- 1,320,000
Additions to property and equipment (2,514,000) (435,000)
Proceeds from the sale of property and equipment 1,000 14,000
-------------- -----------
Net cash provided (used) by investing activity (2,513,000) 899,000
Financing activity
Proceeds from notes payable 9,563,000 3,208,000
Debt issue cost --- (294,000)
Payments of notes payable (193,000) (1,232,000)
Preferred stock dividend --- (98,000)
Redemption of preferred stock --- (2,805,000)
Proceeds from the sale of common stock, and exercise
of common stock options and warrants 4,522,000 2,083,000
Issue cost of common stock --- (294,000)
-------------- -----------
Net cash provided by financing activity 13,892,000 568,000
-------------- -----------
Net increase (decrease) in cash and cash equivalents 2,981,000 (4,987,000)
Cash and cash equivalents at beginning of period 1,937,000 7,244,000
-------------- -----------
Cash and cash equivalents at end of period $ 4,918,000 $ 2,257,000
============== ===========
</TABLE>
See accompanying notes.
6
<PAGE>
<TABLE>
<CAPTION>
NaPro BioTherapeutics, Inc.
Cash Flow Statement (continued)
(Unaudited)
Nine Months Ended
September 30,
2000 1999
---- ----
Supplemental schedule of activity
<S> <C> <C>
Interest paid $ 290,000 $ 151,000
Noncash transactions:
Conversion of senior convertible debt to
common stock --- 4,958,000
Conversion of convertible preferred shares to
common stock --- 2,103,000
Accretion of convertible preferred stock conversion
rights valuation, offering cost and warrant valuation --- 298,000
Issuance of common stock as payment of dividends --- 11,000
Cashless exercise of warrants --- 62,000
Issuance of common stock to prepay retirement
plan contributions 215,000 479,000
Depletion of plantation cost to inventory 371,000 ---
</TABLE>
See accompanying notes.
7
<PAGE>
NaPro BioTherapeutics, Inc.
Notes to Consolidated Financial Statements
September 30, 2000
(Unaudited)
1. Basis of Presentation
The accompanying financial statements are unaudited. However, in the opinion of
management, the financial statements reflect all adjustments, consisting of only
normal recurring adjustments, necessary for fair presentation. Interim results
of operations are not indicative of results for the full year. These financial
statements should be read in conjunction with the NaPro Annual Report on Form
10-K for the year ended December 31, 1999.
2. Loss on Retirement of Assets
NaPro initiated the construction of expanded manufacturing facilities in
Boulder, Colorado in 1996 and suspended construction in 1998. NaPro restarted
construction in the June 2000 quarter in anticipation of possible increased
demand for NaPro paclitaxel. In the 2000 period NaPro expensed $2.2 million of
construction cost incurred that no longer had utility because of manufacturing
improvements and design changes.
3. Earnings per Share
The following table sets forth the computation of basic and diluted net loss per
share. In calculating diluted net loss per share, the impact of shares other
than basic shares is antidilutive, and thus not included in the calculation.
<TABLE>
<CAPTION>
Quarter Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
------ ------ ------ -----
Numerator:
<S> <C> <C> <C> <C>
Net loss $(3,412,000) $(2,052,000) $(12,096,000) $(5,581,000)
Preferred stock dividends --- (236,000) --- (401,000)
Preferred stock redemption premium --- (805,000) --- (805,000)
----------------- ------------- ------------------- --------------
Numerator: loss attributable to
common stockholders $(3,412,000) $(3,093,000) $(12,096,000) $(6,787,000)
============ ============ ============= ============
Denominator: weighted average shares 24,059,704 22,307,471 23,502,744 19,753,939
------------ ------------ ============= ===========
Basic and diluted net loss per share $ (0.14) $ (0.14) $ (0.51) $ (0.34)
=============== =============== =============== ==============
</TABLE>
4. Authorized shares
On September 13, 2000 the NaPro stockholders approved a 15,000,000 share
increase in authorized common stock, to 45,000,000 shares.
8
<PAGE>
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations
The following discussion and analysis provide information that NaPro's
management believes is relevant to an assessment and understanding of the
Company's results of operations and financial condition. This discussion should
be read in conjunction with the consolidated financial statements and notes
thereto appearing elsewhere herein as well as with the consolidated financial
statements, notes thereto and the related management's discussion and analysis
of financial condition and results of operations included in NaPro's Annual
Report on Form 10-K for the year ended December 31, 1999.
General
NaPro is a natural product pharmaceutical company focused primarily on the
development, manufacture and commercialization of chemotherapeutic agents and
related technologies. Natural product substances are a potential source of new
anti-cancer agents, especially compounds which exert their anti-cancer activity
by novel mechanisms of action. NaPro's lead product is paclitaxel, a naturally
occurring chemotherapeutic agent found in certain species of yew (Taxus) trees.
In addition to its efforts with paclitaxel, NaPro is actively engaged in
evaluating the in-licensing or purchase of potential new products and/or
technologies, either derived from natural products or otherwise. Such
evaluations may involve individual molecules, classes of compounds or platform
technologies, in, or outside, the cancer field, including genetics, genomics,
molecular biology and pharmaceutical compounds targeting other disease states.
The evaluations may lead to the acquisition in whole or in part of entire
private or publicly traded companies. NaPro is also working internally on
several classes of compounds and on targeted delivery technology, some of which
have in vitro and in vivo activity as anti-tumor agents that function by new and
novel mechanisms that may increase the likelihood of their success as new
chemotherapeutic agents. NaPro is in active discussions with third parties and
remains committed to the diversification of its business through the acquisition
and development of new technologies, products and compounds.
Regarding paclitaxel, NaPro has devoted its efforts to the development and
implementation of its proprietary extraction, isolation and purification
(EIP(TM)) technology and the development of its proprietary semisynthetic method
for producing NaPro paclitaxel. To advance the development and commercialization
of NaPro paclitaxel, NaPro has entered into 20-year exclusive agreements with
Abbott Laboratories and F.H. Faulding & Co., Ltd. for the clinical development,
sales, marketing and distribution of NaPro paclitaxel. Abbott may terminate the
Abbott agreement at any time with or without cause. Should Abbott terminate
without cause, it is obligated to make certain payments to NaPro. The Abbott
territory includes the U.S. and Canada. The Faulding territory includes Latin
America, Asia, South Africa and much of the Middle East. NaPro continues to seek
partners for Europe and Japan.
On March 20, 1998, NaPro and Ivax Corporation terminated a prior agreement for
the development of NaPro paclitaxel.
NaPro continues to incur substantial expense for research and development
related to clinical trials, improving manufacturing processes and other
development activity. Accordingly, NaPro has incurred significant operating
losses, including operating losses of approximately $10.8 million and $13.4
million for the years ended December 31, 1999 and 1998, respectively. For the
quarter ended September 30, 2000, NaPro recorded an operating loss of $3.4
million, resulting in an accumulated deficit of $64.7 million. NaPro expects
that it will continue to have a high level of operating expense and will be
required to make significant up-front expenditures in connection with its
clinical trial activity, biomass
9
<PAGE>
procurement, product development and other research and development activity.
NaPro anticipates that operating losses will continue until such time, if ever,
as NaPro is able to generate sufficient revenue to support its operations.
NaPro's ability to generate sufficient revenue to support its operations depends
primarily upon the successful completion of a joint drug development program
with Abbott culminating in approval of a marketing application by the U.S. Food
and Drug Administration, followed by Abbott's successful marketing of NaPro
paclitaxel.
The compound, paclitaxel, is not patented. Bristol-Myers Squibb Company has
obtained, however, U.S. patents covering the method of administration upon which
its FDA approval was received. A number of companies have filed applications
with the FDA for generic paclitaxel based on Bristol's initial FDA approval.
Anyone obtaining FDA approval for generic paclitaxel must rely upon a method of
administration that might infringe the Bristol patents. Bristol has sued those
companies that are seeking FDA approval for generic paclitaxel for infringement
of its patents. The court before which the action is pending ruled that several
key claims of the patents are invalid. The court has approved an expedited
appeal of the ruling.
The FDA has approved two Abbreviated New Drug Applications, referred to as
ANDA's, covering paclitaxel for companies affiliated with Ivax and has
tentatively approved a paclitaxel ANDA for at least one other company. NaPro
believes, but cannot assure, that the FDA will approve its paclitaxel in 2001 or
2002 through an ANDA.
NaPro has received and will, contingent upon successful development of product
and achievement of milestones, receive funding from Abbott in the form of
development and marketing milestone payments, a secured loan and an equity
investment. In 1999, NaPro received $8 million, consisting of an initial $1
million fee, $2 million from the purchase by Abbott of NaPro common stock at
$5.00 per share, and a $5 million draw-down on the secured loan. In the nine
months ended September 2000 NaPro drew down $9.1 million on the secured loan and
received $4 million for the issuance of 711,111 shares of common stock.
Contingent upon NaPro's successful achievement of all development milestones and
including payments received to date, NaPro could receive up to $45 million from
Abbott consisting of $34 million in development fees and up to $11 million for
the purchase of 2 million shares of NaPro common stock. In addition, NaPro has
access to up to a total of $20 million under a secured loan arrangement with
Abbott, including the draws received to date. The loan bears a primary interest
rate of 6.5% and is due in full on the earlier of: 1) the second anniversary of
the first sale of finished product by Abbott to a wholesaler or end-user
customer following approval of finished product by the FDA; 2) the termination
of the Abbott agreement; or 3) January 1, 2007. The loan is limited to a
borrowing base of collateralized assets, recomputed monthly. Substantially all
of NaPro's hard assets serve as security for the loan.
Contingent upon receiving regulatory approval and achieving certain commercial
sales thresholds over several years, NaPro may receive additional milestone
payments from Abbott in the range of zero to $57 million. NaPro cannot assure
that regulatory approval or sales thresholds will be achieved.
10
<PAGE>
Results of Operations
Quarter ended September 30, 2000, compared to the quarter ended September 30,
1999 Sales for the 2000 quarter were $2.3 million, an increase of $200,000 from
the 1999 quarter. The increase related primarily to an $800,000 increase in
sales to Faulding, to $2.3 million, which was partially offset in the 1999
quarter by the final shipment to Ivax under the termination agreement. In June
2000 NaPro expanded the license to Faulding to include all of Latin America,
South Africa and certain additional territories in Asia and the Middle East,
increasing the Faulding territory to more than 70 countries. In 2000 Faulding
has increased the number of countries in which it sells. NaPro believes that
such increases will continue. While shipments to Faulding have increased for the
year, NaPro cannot be assured of an increased level of sales for future years.
Shipments to strategic partners may vary significantly on a quarter-to-quarter
basis depending on a number of factors including the level of sales to the
customers of the strategic partners, changes in approved markets, and the level
of inventory carried by the strategic partners. This quarter-to-quarter
variability will continue until stable commercial demand has been established
for NaPro paclitaxel in a major market. Should U.S. ANDA approval be received
for NaPro paclitaxel, revenue is expected to increase.
Research and development and cost of products sold expense for the 2000 quarter
was $3.6 million, an increase of $100,000 from the 1999 quarter. The increase
resulted primarily from an increase in the cost of products sold because of
higher sales volume, partially offset by production efficiencies.
General and administrative expense for the 2000 quarter was $2.1 million, an
increase of $100,000 from the 1999 quarter. The increase was primarily
attributable to increased travel and recruiting expense.
In the 1999 quarter NaPro earned $1.3 million of license fee income. NaPro had
no comparable income in the 2000 quarter. This income related to a license fee
paid in conjunction with the Abbott agreement and a license fee paid by Ivax
under its termination agreement. The license fee income under the termination
agreement was fully earned by the end 1999.
Nine months ended September 30, 2000, compared to the nine months ended
September 30, 1999 Sales for the 2000 period were $6.4 million, up $200,000 from
the 1999 period. A $2.5 million increase in product sales to Faulding in 2000,
to $6.3 million, was offset by sales to Ivax in 1999. Should U.S. ANDA approval
be received for NaPro paclitaxel, revenue is expected to increase.
Research and development and cost of products sold expense for the 2000 period
was $10.2 million, an increase of $1 million from the 1999 period. The increase
resulted primarily from increased clinical trial expense.
General and administrative expense for the 2000 period was $5.7 million, an
increase of $1.3 million from the 1999 period. The increase was primarily
attributable to increased payroll expense and regulatory activity.
Loss on retirement of assets for the 2000 period was $2.2 million. There was no
comparable expense in the 1999 period. NaPro initiated the construction of
expanded manufacturing facilities in Boulder, Colorado in 1996 and suspended
construction in 1998. NaPro restarted construction in the June 2000 quarter in
anticipation of possible increased demand for NaPro paclitaxel. In the 2000
period NaPro
11
<PAGE>
expensed $2.2 million of construction cost incurred that no longer had utility
because of manufacturing improvements and design changes.
In the 1999 period NaPro earned $2.3 million of license fee income. NaPro had no
comparable income in the 2000 period. This income related to a license fee paid
in conjunction with the Abbott agreement and a license fee paid by Ivax under
its termination agreement.
The extraordinary item for the 1999 period was $200,000. There was no similar
amount in the 2000 period. This item was a loss on early extinguishment of debt
resulting from the early redemption of a portion of NaPro's senior convertible
debt.
Liquidity and Capital Resources
NaPro's capital requirements have been and will continue to be significant. As
of September 30, 2000, NaPro had a working capital balance of $8 million
compared to a working capital balance of $2.9 million as of December 31, 1999.
NaPro has a $20 million secured borrowing arrangement with Abbott, of which
$14.1 million was outstanding as of September 30, 2000. To date, the funding of
NaPro's capital requirements has been dependent primarily on the net proceeds of
public offerings of its common stock of approximately $21.1 million, on private
placements of its securities of approximately $43.6 million, on the exercise of
warrants and options of $6.4 million and on net borrowings of $14.2 million.
NaPro's agreement with Abbott is expected to be a significant ongoing capital
source. See Management's Discussion and Analysis - General.
NaPro believes its existing capital, anticipated sales in 2000, and available
borrowing and milestone payments from its development partners can provide
adequate funding for its necessary operations and capital expenditures in the
near future. The cost of developing and acquiring new pharmaceutical products,
and related capital and operating expenditures, may be significant in the
future. NaPro, therefore, expects to seek additional capital in the near future,
which may include the sale of common stock, if it is available at financially
acceptable terms. NaPro cannot assure that it will be able to do so. In addition
to its efforts with paclitaxel, NaPro is actively engaged in evaluating the
in-licensing or purchase of potential new products and/or technologies, either
derived from natural products or otherwise. Such evaluations may involve
individual molecules, classes of compounds or platform technologies, in, or
outside, the cancer field, including genetics, genomics, molecular biology and
pharmaceutical compounds targeting other disease states. The evaluations may
lead to the acquisition in whole or in part of entire private or publicly traded
companies. NaPro anticipates paying for such in-licensing or purchase(s) with
cash, notes, royalty payments and/or stock. NaPro cannot assure that it will be
able to do so.
In June 1997, NaPro privately placed $10.3 million of senior convertible notes.
The notes bore interest of 5% and were all redeemed or converted into common
stock by July 1999. Interest on the notes was payable in cash or in common stock
at NaPro's option. In 1999 NaPro issued 3,585,203 shares of common stock in
conversion of $5,061,000 principal of the notes, and 19,234 shares of common
stock in payment of $27,000 interest on the notes. In 1999 NaPro redeemed
$633,000 in note principal and paid $162,000 premium and interest in connection
with the redemption.
12
<PAGE>
In December 1997, NaPro privately placed 5,000 shares of Series C Senior
Convertible Preferred Stock for an aggregate issuance price of $5 million. The C
Preferred accrued dividends at 5% per year payable in common stock or cash at
NaPro's option. In 1999, NaPro issued 1,299,085 shares of common stock in
conversion of the C Preferred and 6,761 shares of common stock in payment of
dividends on the C Preferred. By September 1999, all of the C Preferred had been
redeemed or converted into common stock. NaPro exercised its option to redeem $2
million of the C Preferred at 140% of the outstanding principal and accrued
dividends in August 1999.
Working Capital and Cash Flow Cash and cash equivalents increased $3 million to
$4.9 million for the nine months ended September 30, 2000 from $1.9 million at
December 31, 1999. During the 2000 period net cash used by operations of $8.4
million and by investment activity of $2.5 million was offset by financing
activity of $13.9 million. NaPro currently finances working capital requirements
on an as- needed basis through draws on the Abbott loan.
Inventory increased $100,000 from December 31, 1999 to $4.8 million at September
30, 2000. The amount of inventory is dependent on a number of factors, including
the shipping requirements of NaPro's strategic partners, NaPro's production
planning for meeting those needs, and the timing of biomass harvests. Inventory
balances may vary significantly during product development and launch periods.
Capital Expenditures NaPro expended $2.5 million during the 2000 nine month
period for capital projects. These expenditures primarily included expansion of
NaPro's manufacturing facilities, plantation cost and laboratory equipment.
NaPro anticipates additional expenditures in the near term, particularly for
expansion of manufacturing facilities.
The amount and timing of future capital expenditures will depend upon a number
of factors, including the cost of manufacturing scale-up for paclitaxel; the
cost of development of new products; the cost of manufacturing resources for new
products; the nature of NaPro's relationship with its strategic partners; the
establishment of additional strategic relationships; the progress of NaPro's
research and development programs; the magnitude and scope of these activities;
the cost of preparing, filing, prosecuting, maintaining and enforcing patent
claims and other intellectual property rights; competing technological and
marketing developments; and changes in or terminations of existing strategic
relationships. NaPro may seek additional long-term financing to fund capital
expenditures should such financing become available on terms acceptable to
NaPro.
Special Note Regarding Forward-looking Statements
This report contains forward-looking statements that involve known and unknown
risks, including, without limitation, statements containing the words
"believes", "anticipates", "estimates", "may" and words of similar import or
statements of management's opinion or statements that are not historical fact.
Such forward-looking statements include, among others:
statements concerning NaPro's plans, objectives and future economic
prospects, such as matters relative to seeking and obtaining additional
strategic partners and developing new products;
the availability of patent and other protection for its intellectual
property;
the completion of clinical trials and regulatory filings;
13
<PAGE>
the prospects for and timing of regulatory approvals;
the need and plans for and availability of additional capital;
the amount and timing of capital expenditures;
the timing of product introductions and revenue;
the availability of raw materials;
prospects for future operations; and
other statements of expectations, beliefs, future plans and strategies,
anticipated events or trends and similar expressions concerning matters
that are not historical facts.
Such forward-looking statements involve known and unknown risks, uncertainties
and other factors which may cause the actual results, performance or
achievements of NaPro, or industry results, to be materially different from any
future results, performance or achievements expressed or implied by such
forward-looking statements. Such factors include, among other things, the
following:
adverse economic and general business conditions;
competition from Bristol and other existing and new producers of
paclitaxel and other drugs;
technological advances in cancer treatment and drug development that
may obsolesce paclitaxel;
the ability to obtain rights to technology;
the ability to obtain and enforce patents;
the ability to maintain trade secrets;
the ability to obtain raw materials and commercialize manufacturing
processes;
the effectiveness of NaPro paclitaxel and other pharmaceuticals
developed by NaPro in treating disease;
the results of clinical studies;
the results of research and development activities;
the ability to purchase or license new products;
the successful development of new products;
the business abilities and judgment of NaPro's management and other
personnel;
14
<PAGE>
the ability to hire skilled personnel to perform research and
development and to run NaPro's manufacturing operations;
the ability of contract manufacturers to perform adequately under
anticipated contracts;
changes in and compliance with governmental regulations;
the decision-making processes of regulatory agencies;
the effect of capital market conditions and other factors on capital
availability for NaPro and other biopharmaceutical companies;
the ability of Abbott and Faulding to perform their obligations under
their existing agreements with NaPro;
the ability of NaPro to perform its obligations under its existing
agreements with Abbott and Faulding;
the ability of NaPro to establish relationships with capable strategic
partners to develop and market NaPro paclitaxel in the territories not
covered by the Abbott and Faulding agreements;
NaPro's limited relevant operating history upon which an evaluation of
its prospects can be made;
the effect on NaPro's revenue, cash flow and earnings from foreign
exchange rate fluctuations;
and other factors referenced in this report.
The forward-looking statements included in this report represent NaPro's view as
of the date of this report, and the reader should not assume that the statements
made herein remain accurate at any future date. NaPro does not intend to update
these statements and undertakes no duty to any person to make any update under
any circumstance.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
During the nine months ended September 30, 2000, virtually all of NaPro's
revenue resulted from sales of NaPro paclitaxel to Faulding. In the absence of
sales to another strategic partner, sales of NaPro paclitaxel to Faulding will
constitute substantially all of NaPro's sales revenue in 2000. NaPro anticipates
that sales to Abbott will be quite limited until such time, if ever, as NaPro
and Abbott obtain approval for commercial sales of NaPro paclitaxel.
Faulding purchases NaPro paclitaxel from NaPro at a price that varies in
proportion to the price at which Faulding sells NaPro paclitaxel. Under the
Faulding agreement, NaPro is paid a fixed percentage of Faulding's sales price
for NaPro paclitaxel. Each year, Faulding estimates the sales price it will
receive for NaPro paclitaxel in the upcoming year, and, based upon that
estimate, NaPro determines the price it will charge Faulding for NaPro
paclitaxel (the "Unadjusted Price"). NaPro recognizes the corresponding revenue
at the time of shipment of NaPro paclitaxel to Faulding. However, Faulding's
actual selling price may differ from the amounts originally budgeted and
indicated to NaPro on its purchase orders. On or
15
<PAGE>
about May 31, 2001, Faulding will communicate to NaPro the final amount and type
of sales made during the period beginning on April 1, 2000 and ending on March
31, 2001, and an adjustment will be calculated that may increase or decrease
NaPro's revenue from sales of products to Faulding during this period.
Faulding's sales are made in the currencies of each of the countries in which it
sells NaPro paclitaxel. As a result, NaPro's revenue from sales is affected by
fluctuations in the value of these various foreign currencies relative to the
U.S. dollar. In the past, fluctuations in various currencies have been a
significant factor in prior reductions in the Unadjusted Price. If changes in
foreign currency markets continue to cause a decrease in the price per gram
NaPro receives from Faulding, there could be a material adverse effect on
NaPro's earnings and cash flow. For example, during the period beginning April
1, 1999 and ending March 31, 2000, sales of NaPro paclitaxel to Faulding totaled
$4.7 million. Had there been additional negative pressure on the relevant
exchange rates such that the Unadjusted Price had been reduced by 10% NaPro's
earnings would have been reduced by approximately $500,000 and NaPro would have
experienced reduced cash flow. However, while sales to Faulding will continue to
have an impact on NaPro's revenue, NaPro's continuation of operations is
dependent upon sources other than revenue from Faulding. NaPro anticipates that
its operations will be dependent upon borrowing and equity funding provided by
the strategic alliance with Abbott and, perhaps, other sources of capital. See
Item 2 - Management's Discussion and Analysis.
To the extent NaPro's efforts in developing international markets outside the
Faulding territories are successful, NaPro may face similar foreign currency
exchange risk as that described above for Faulding.
Certain statements set forth in Item 3 may constitute "forward-looking
statements". See "Special Note Regarding Forward-looking Statements."
Part II--Other Information
Item 1. Legal Proceedings
On September 18, 2000, NaPro, together with its licensee Abbott Laboratories,
filed a complaint against Bristol Myers Squibb Company in the United States
District Court for Colorado alleging infringement of NaPro's U.S. patents #
5,972,992 and 5,977,164 for paclitaxel, an ingredient in the drug Bristol sells
as Taxol(R), and seeking damages and other relief. On October 31, 2000 NaPro was
issued U.S. patent # 6,140,359; NaPro and Abbott have amended the complaint in
the above referenced litigation to include this patent. Pursuant to certain
arrangements between NaPro and Abbott, Abbott will be responsible for the cost
associated with the aforementioned litigation.
Item 2. Changes in Securities. None.
Item 3. Defaults upon Senior Securities. None.
Item 4. Submission of Matters to a Vote of Securities Holders
At the Annual Meeting of Stockholders held on September 13, 2000, the following
proposals were adopted by the margins indicated:
16
<PAGE>
1. The election of three Class I directors to hold office until the 2003 Annual
Meeting, two Class II directors to serve until the 2001 Annual Meeting, and one
Class III director to serve until the 2002 Annual Meeting:
<TABLE>
<CAPTION>
Number of Shares
Nominee Class For Withheld
------- ----- --- --------
<S> <C> <C> <C>
Edward E. Erickson II 19,622,568 559,215
Arthur H. Hayes I 19,485,343 696,440
Marc J. Ostro III 19,653,068 528,715
Richard N. Perle II 19,633,868 547,915
Robert E. Pollack I 19,653,068 528,715
Leonard P. Shaykin I 19,477,243 704,540
</TABLE>
2. Approval of an amendment to NaPro's Certificate of Incorporation
increasing the number of total authorized shares of common stock issuable
thereunder:
Number of Shares
For 19,942,187
Against 925,021
Abstain 14,575
3. Approval of an amendment to NaPro's 1994 Long Term Performance Incentive Plan
increasing the number of shares of common stock issuable thereunder:
Number of Shares
For 16,819,369
Against 3,273,944
Abstain 88,470
4. To ratify the selection by the Board of Directors of Ernst & Young LLP as
NaPro's independent auditors for the year ending December 31, 2000:
Number of Shares
For 20,167,066
Against 10,017
Abstain 4,700
Item 5. Other Information. None.
Item 6. Exhibits and Reports on Form 8-K
Current reports on Form 8-K: October 31, 2000.
Exhibit
Number Description of Exhibit
3.1 Amended and Restated Certificate of Incorporation of NaPro, as amended
September 13, 2000
27.1 Financial Data Schedule.
17
<PAGE>
Signatures
Pursuant to the requirements of the Securities Exchange Act of 1934, NaPro has
duly caused this report to be signed on its behalf.
NaPro BioTherapeutics, Inc.
November 13, 2000 /s/ Leonard P. Shaykin
Leonard P. Shaykin
Chairman of the Board of Directors
Chief Executive Officer
(Principal Executive Officer)
November 13, 2000 /s/ Gordon Link
Gordon Link
Vice President and Chief Financial Officer
(Principal Financial Officer)
November 13, 2000 /s/ Robert L. Poley
Robert L. Poley
Controller
(Principal Accounting Officer)
18
