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 June 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 July 31, 2000:
Common Stock, $.0075 par value 24,056,404
Non-voting Common Stock, $.0075 par value 395,000
Total number of pages in document--18
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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 16
Exhibits and Reports on Form 8-K 16
Signatures 18
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Part I. Financial Information
Item 1. Consolidated Financial Statements
NaPro BioTherapeutics, Inc.
Balance Sheet
Assets
June 30, December 31,
2000 1999
------ ----
(unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 6,068,000 $ 1,937,000
Accounts receivable 3,295,000 1,416,000
Inventory 3,012,000 2,188,000
Prepaid expense and other 886,000 153,000
------------- -------------
Total current assets 13,261,000 5,694,000
Property and equipment, net 8,410,000 10,693,000
Inventory 2,098,000 2,454,000
Other assets 312,000 416,000
------------- --------------
Total assets $24,081,000 $19,257,000
=========== ===========
</TABLE>
See accompanying notes
3
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<TABLE>
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NaPro BioTherapeutics, Inc.
Balance Sheet
Liabilities and Stockholders' Equity
June 30, December 31,
2000 1999
------ -----
(unaudited)
<S> <C> <C>
Current liabilities:
Accounts payable $ 2,254,000 $ 2,174,000
Accrued payroll and payroll taxes 1,569,000 557,000
Notes payable--current portion 253,000 48,000
--------------- ---------------
Total current liabilities 4,076,000 2,779,000
Notes payable--long term 11,578,000 4,723,000
------------- -------------
Total liabilities 15,654,000 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:
30,000,000 authorized
24,448,455 shares issued in 2000 (unaudited),
and 23,482,671 in 1999 183,000 176,000
Additional paid-in capital 70,265,000 65,358,000
Deficit (61,304,000) (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 7,805,000 11,133,000
------------- ------------
Total liabilities and stockholders' equity $ 24,081,000 $ 19,257,000
============= ============
</TABLE>
See accompanying notes
4
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NaPro BioTherapeutics, Inc.
Statement of Operations
(Unaudited)
Quarter Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
------ ------ ------ -----
<S> <C> <C> <C> <C>
Sales $ 3,298,000 $ 1,950,000 $ 4,031,000 $ 3,987,000
Expense:
Research, development and
cost of products sold 4,510,000 2,882,000 6,626,000 5,693,000
General and administrative 2,063,000 1,241,000 3,637,000 2,455,000
(Gain) loss on retirement
of assets 2,245,000 (1,000) 2,245,000 7,000
------------- ------------- ------------- -------------
8,818,000 4,122,000 12,508,000 8,155,000
------------- ------------- ------------- -------------
Operating loss (5,520,000) (2,172,000) (8,477,000) (4,168,000)
License fee --- 680,000 --- 1,020,000
Interest income 37,000 44,000 66,000 119,000
Interest expense (162,000) (142,000) (273,000) (318,000)
------------- ------------- ------------- -------------
Loss before extraordinary
item (5,645,000) (1,590,000) (8,684,000) (3,347,000)
Extraordinary item--loss on early
extinguishment of debt --- --- --- (182,000)
------------- ------------- ------------- -------------
Net loss $(5,645,000) $(1,590,000) $(8,684,000) $(3,529,000)
============= ============= ============= =============
Basic and diluted loss per share
Loss before extraordinary
item $ (0.24) $ (0.09) $ (0.37) $ (0.19)
Extraordinary item--loss on
early extinguishment of debt --- --- --- (0.01)
------------- ------------- ------------- -------------
Net loss $ (0.24) $ (0.09) $ (0.37) $ (0.20)
============= ============= ============= =============
Weighted average shares outstanding 23,362,717 19,239,884 23,221,204 18,456,012
============= ============= ============= =============
</TABLE>
See accompanying notes.
5
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NaPro BioTherapeutics, Inc.
Cash Flow Statement
(Unaudited)
Six Months Ended
June 30,
2000 1999
------ ------
<S> <C> <C>
Operating activity
Net loss $ (8,684,000) $(3,529,000)
Adjustments to reconcile net loss to net cash
provided (used) by operating activity:
Depreciation 745,000 783,000
Accretion of debt issue cost, warrant allocation
and conversion rights allocation 20,000 188,000
Retirement contributions paid with common stock 444,000 235,000
Interest expense paid with common stock --- 17,000
Loss on retirement of assets 2,245,000 7,000
Loss on early extinguishment of debt --- 28,000
Changes in operating assets and liabilities:
Accounts receivable (1,879,000) (836,000)
Inventory (97,000) 389,000
Prepaid expense and other assets (198,000) 333,000
Accounts payable 80,000 (28,000)
Accrued liabilities 1,012,000 83,000
Deferred revenue --- (2,242,000)
------------- -------------
Net cash used by operating activity (6,312,000) (4,572,000)
Investing activity
Transfer of restricted cash --- 1,020,000
Additions to property and equipment (1,079,000) (265,000)
Proceeds from the sale of property and equipment 1,000 14,000
------------- -------------
Net cash provided (used) by investing activity (1,078,000) 769,000
Financing activity
Proceeds from notes payable 7,162,000 208,000
Preferred stock dividend --- (84,000)
Payments of notes payable (122,000) (1,179,000)
Proceeds from the sale of common stock, and exercise
of common stock options and warrants 4,481,000 ---
------------- -------------
Net cash provided (used) by financing activity 11,521,000 (1,055,000)
------------- -------------
Net increase (decrease) in cash and cash equivalents 4,131,000 (4,858,000)
Cash and cash equivalents at beginning of period 1,937,000 7,244,000
------------- -------------
Cash and cash equivalents at end of period $ 6,068,000 $ 2,386,000
============= =============
</TABLE>
See accompanying notes.
6
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NaPro BioTherapeutics, Inc.
Cash Flow Statement (continued)
(Unaudited)
Six Months Ended
June 30,
2000 1999
---- ----
Supplemental schedule of activity
<S> <C> <C>
Interest paid $ 273,000 $ 173,000
Noncash transactions:
Conversion of senior convertible debt to
common stock --- 3,668,000
Conversion of convertible preferred shares to
common stock --- 1,056,000
Accretion of convertible preferred stock conversion
rights valuation, offering cost and warrant valuation 76,000
Issuance of common stock as payment of dividends 5,000
Issuance of common stock to prepay retirement
plan contributions 431,000 899,000
Depletion of plantation cost to inventory 371,000 ---
</TABLE>
See accompanying notes.
7
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NaPro BioTherapeutics, Inc.
Notes to Consolidated Financial Statements
June 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.
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2. Inventory June 30, December 31,
2000 1999
----------- ------------
<S> <C> <C>
Raw materials $ 192,000 $ 129,000
Work-in-process 1,208,000 481,000
Finished goods 1,612,000 1,578,000
----------- ----------
$3,012,000 $2,188,000
========== ==========
Non-current inventory
Raw materials $2,098,000 $1,562,000
Work-in-process --- 892,000
--------------- -----------
$2,098,000 $2,454,000
========== ==========
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3. Common Stock
In the June 2000 quarter NaPro issued 711,111 shares of common stock to Abbott
Laboratories for $4 million in cash upon achievement of the first milestone
under NaPro's agreement with Abbott.
4. Loss on Retirement of Assets
In 1996 NaPro initiated the construction of expanded manufacturing facilities in
Boulder, Colorado. NaPro suspended such construction in 1998. Due to the signing
of the agreement with Abbott and other reasons, NaPro has restarted such
construction. Because of manufacturing improvements and design changes, certain
cost incurred in the earlier construction which had been recorded in fixed
assets as construction-in-progress no longer has utility in the current
improvements. Accordingly, in the June 2000 quarter NaPro expensed $2.2 million
of such cost.
5. 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.
8
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Quarter Ended Six Months Ended
June 30, June 30,
2000 1999 2000 1999
<S> <C> <C> <C> <C>
Numerator:
Net loss $(5,645,000) $(1,590,000) $(8,684,000) $(3,529,000)
Preferred stock dividends --- (78,000) --- (165,000)
------------ ------------ ------------ ------------
Numerator for loss per share - loss
attributable to common stockholders $(5,645,000) $(1,668,000) $(8,684,000) $(3,694,000)
============ ============ ============ ============
Denominator:
Denominator for loss per share -
weighted average shares 23,362,717 19,239,884 23,221,204 18.456.012
------------ ------------ ------------ ------------
Basic and diluted net loss per share $ (0.24) $ (0.09) $ (0.37) $ (0.20)
============ ============ ============ ============
</TABLE>
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 cancer chemotherapeutic agents
and related technologies. Natural product substances are a potential source of
new prototype 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 anti-cancer 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, both in the cancer field and
otherwise, which could involve the acquisition 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 products and compounds.
Regarding paclitaxel, NaPro has devoted its efforts to the development and
implementation of its propriety 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. The Abbott territory
includes the U.S. and Canada. The Faulding
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territory includes Latin America, Asia, South Africa and much of the Middle
East. NaPro continues to seek partners for Europe and Japan.
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 June 30, 2000, NaPro recorded an operating loss of $5.5 million,
resulting in an accumulated deficit of $61.3 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 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 an application for marketing approval by the U.S.
Food and Drug Administration, followed by Abbott's successful marketing of the
product. In addition to the NaPro-Abbott drug development program efforts, NaPro
is actively searching for other partners to facilitate the marketing of its
paclitaxel in major markets outside the United States.
On July 23, 1999, NaPro and Abbott entered into a collaborative agreement with a
term of up to 20 years to develop and commercialize one or more formulations of
paclitaxel for the treatment of a variety of cancer indications. The exclusive
agreement covers the United States and Canada. Abbott may terminate the
agreement at any time with or without cause. Should Abbott terminate without
cause, it is obligated to make certain payments to NaPro.
NaPro is responsible for supply of bulk drug and is jointly conducting a
paclitaxel development program with Abbott. Abbott is responsible for finishing,
regulatory filings, marketing and sale of the drug product. NaPro has licensed
its paclitaxel-related patents to Abbott. Most primary decisions related to the
development program are made by a joint NaPro-Abbott Development Committee.
NaPro has planned with Abbott to explore the use of NaPro's patented formulation
of paclitaxel using its patented method of administration. NaPro anticipates
that information gained in such program will be useful in the filing of a
regulatory submission with the FDA for NaPro paclitaxel. The cost of such
program will be significant.
In June 2000, in connection with achieving its first milestone payment under the
Abbott agreement, NaPro received a $4 million payment from Abbott in the form of
cash for 711,111 shares of common stock at $5.625 per share. It is NaPro's
practice not to disclose events that trigger milestone payments under the Abbott
agreement. This agreement has been amended to expand the scope of the
relationship between the two companies and to, among other things, provide
increased flexibility to deal with the development and marketing of paclitaxel
in the United States.
The compound, paclitaxel, is not patented. Bristol-Myers Squibb Co. 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 upon Bristol's initial FDA
approval. Anyone obtaining FDA approval for generic paclitaxel will rely upon a
method of administration that might infringe the Bristol patents. Bristol has
sued those companies that are seeking
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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. NaPro and
Abbott are reviewing the effects of the foregoing on their drug development
program.
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 six
months ended June 2000 NaPro drew down $6.7 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.
Under terms of the Abbott Agreement, Abbott will purchase bulk drug from NaPro.
Once the paclitaxel product is approved and commercialized, if ever, Abbott will
pay a percentage of its net paclitaxel sales to NaPro, less Abbott's payments to
NaPro for purchase of bulk drug.
On June 5, 2000, NaPro expanded its development and marketing relationship for
paclitaxel with Faulding to include all of Latin America, South Africa and
certain additional territories in southeast Asia and the Middle East, increasing
the Faulding territory to more than 70 countries. Faulding has received
marketing approval in more than 20 countries and is selling in a number of
countries where regulatory authorities permit sales prior to final regulatory
approval. NaPro sales to Faulding increased to $3.9 million in the six months
ended June 2000 from $2.2 million in the six months ended June 1999.
Results of Operations
Quarter ended June 30, 2000, compared to the quarter ended June 30, 1999 Sales
for the 2000 quarter were $3.3 million, an increase of $1.3 million from the
1999 quarter. The increase related primarily to an increase in product shipments
to Faulding. 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 the
product in a major market.
11
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Research and development and cost of products sold expense for the 2000 quarter
was $4.5 million, an increase of $1.6 million from the 1999 quarter. The
increase resulted primarily from increased clinical trial expense and an
increase in the level of cost of product 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 $800,000 from the 1999 quarter. The increase was primarily
attributable to increased payroll cost.
Loss on retirement of assets for the 2000 quarter was $2.2 million. There was no
comparable expense in the 1999 quarter. In 1996 NaPro initiated the construction
of expanded manufacturing facilities in Boulder, Colorado. NaPro suspended such
construction in 1998. Due to the signing of the agreement with Abbott and other
reasons, NaPro has restarted such construction. Because of manufacturing
improvements and design changes, certain cost incurred in the earlier
construction that had been recorded in fixed assets as construction-in-progress
no longer has utility in the current improvements. Accordingly, in the June 2000
quarter NaPro expensed $2.2 million of such cost.
In the 1999 quarter NaPro earned $700,000 of license fee income. NaPro had no
comparable income in the 2000 quarter. This income related to a one-time license
fee paid by IVAX Corporation in conjunction with the 1998 termination of NaPro's
commercialization agreement with IVAX. The license fee income earned from the
termination was completed in 1999.
Six months ended June 30, 2000, compared to the six months ended June 30, 1999
Sales for the 2000 period were $4 million, up slightly from the 1999 period.
Increased product sales to Faulding in 2000 were offset by the elimination of
sales to IVAX.
Research and development and cost of products sold expense for the 2000 period
was $6.6 million, an increase of $900,000 from the 1999 period. The increase
resulted primarily from increased clinical trial expense.
General and administrative expense for the 2000 period was $3.6 million, an
increase of $1.2 million from the 1999 period. The increase was primarily
attributable to increased payroll expense.
In the 1999 period NaPro earned $1 million of license fee income. NaPro had no
comparable income in the 2000 period. This income related to a license fee paid
by IVAX in conjunction with the termination of NaPro's commercialization
agreement with IVAX.
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 June 30, 2000, NaPro had a working capital balance of $9.2 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 $11.7 million
was outstanding as of June 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
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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 $11.8 million.
On July 23, 1999, NaPro entered into the Abbott Agreement, which is expected to
be a significant ongoing capital source. See Management's Discussion and
Analysis - General.
NaPro's existing capital, anticipated 2000 sales, and available borrowing under
the Abbott loan are expected to provide adequate capital to fund its necessary
operations and capital expenditures in the near future. However, pharmaceutical
development is a costly and time consuming process. NaPro is actively pursuing
additional partners to assist in the development and marketing of its products,
may seek other forms of long-term financing should such financing become
available on acceptable terms and may issue additional equity. NaPro may
in-license or purchase new products or technologies. The cost of acquiring and
developing such resources, and related capital expenditures, may be very large.
As a result, NaPro may need to attract substantial amounts of capital. 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.
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 and interest in August 1999.
Working Capital and Cash Flow Cash and cash equivalents increased $4.1 million
to $6.1 million for the six months ended June 30, 2000 from $1.9 million at
December 31, 1999. During the 2000 period net cash used by operations of $6.3
million and by investment activity of $1.1 million was offset by financing
activity of $11.5 million. NaPro currently finances working capital requirements
on an as-needed basis through draws on the Abbott loan.
Inventory increased $500,000 from December 31, 1999 to $5.1 million at June 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 $1.1 million during the 2000 six 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.
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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
Certain statements in this report constitute "forward-looking statements." In
addition, NaPro or persons acting on its behalf sometimes make forward-looking
statements in other written and oral communications. Such forward-looking
statements may include, among other things:
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;
the prospects for and timing of regulatory approvals;
the need 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;
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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;
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;
15
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and other factors referenced in this report.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
There have been no material changes in market risk subsequent to the market risk
disclosure in the December 31, 1999 Form 10-K.
Part II--Other Information
Item 1. Legal Proceedings
On May 14, 1997, Bristol was issued a European patent relating to certain
methods of treatment with paclitaxel. On the same day, NaPro instituted
revocation proceedings in the United Kingdom against this European Patent as
issued in the U.K. and a separate but related British Patent also owned by
Bristol.
The revocation action was not in response to any lawsuit or allegations of
infringement against NaPro relating to the patents, but Bristol subsequently
sued NaPro and Baker Norton Pharmaceuticals, Inc., a subsidiary of IVAX, in the
United Kingdom, alleging patent infringement with respect to clinical trials
carried out in the United Kingdom involving paclitaxel. NaPro and Baker-Norton
counter-claimed to revoke the patent as invalid. The outcome of the trial of
that action, concerning EP (UK) Patent Number 0,584,001 (the "Bristol Patent")
(GB Patent Number 2,269,319 was surrendered by Bristol), was a judgment rendered
by the English High Court on October 1, 1998. The judge held that the Bristol
Patent was invalid on the basis of lack of novelty and obviousness.
Bristol has lodged a Notice of Appeal dated November 1998 from the High Court
decision. Oral arguments on the appeal were heard in April, 2000, and on May 23,
2000 the Court of Appeal dismissed Bristol's appeal, upholding the lower court's
decision that the patent is invalid. The decision of the Court of Appeal is
subject to possible review by the House of Lords. In view of the minimal
activity, if any, by NaPro in the United Kingdom, NaPro believes that the risk
of an award of substantial damages against NaPro, in the event of an unfavorable
House of Lords ruling, to be low. In addition, Baker-Norton is required to
indemnify NaPro for any damages (not including payment of attorneys' fees)
suffered as a result of this legal action. However, litigation is an uncertain
process, and an adverse result of the appeal could have a material adverse
effect on NaPro.
Item 2. Changes in Securities
In June 2000 NaPro issued 711,111 shares of common stock. See Note 3 to the
financial statements, above. As an issuance to an accredited investor not
involving any public offering, the issuance was exempt under Section 4(2) of the
Securities Act and Regulation D thereunder.
Item 3. Defaults upon Senior Securities. None.
Item 4. Submission of Matters to a Vote of Securities Holders. None.
Item 5. Other Information. None.
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Item 6. Exhibits and Reports on Form 8-K
Current reports on Form 8-K: None.
Exhibit
Number Description of Exhibit
10.1+ Second Amended and Restated Master Agreement dated June 5, 2000 between
NaPro and Faulding.
10.2+ Amendment to Development, License and Supply Agreement dated June 23,
2000 between NaPro and Abbott.
10.3+ Amendment to Stock Purchase Agreement dated June 23, 2000 between NaPro
and Abbott.
27.1 Financial Data Schedule.
----------------
+ Portions have been omitted pursuant to a request for confidential treatment.
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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.
August 11, 2000 /s/ Leonard P. Shaykin
Leonard P. Shaykin
Chairman of the Board of Directors
Chief Executive Officer
(Principal Executive Officer)
August 11, 2000 /s/ Gordon Link
Gordon Link
Vice President and Chief Financial Officer
(Principal Financial Officer)
August 11, 2000 /s/ Robert L. Poley
Robert L. Poley
Controller
(Principal Accounting Officer)
18
