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 March 31, 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. ("NaPro" or "the Company") (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 requirements
for the past 90 days.
The number of shares outstanding of each of the issuer's classes of common stock
as of May 2, 2000:
Common Stock, $.0075 par value 23,331,459
Non-voting Common Stock, $.0075 par value 395,000
Total number of pages in document--17
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NaPro BioTherapeutics, Inc.
Table of Contents
Page
Part I Financial Information
Consolidated Financial Statements
<S> <C>
Balance Sheet 3
Operations Statement 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 15
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 17
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Part I. Financial Information
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Item 1. Consolidated Financial Statements
NaPro BioTherapeutics, Inc.
Balance Sheet
Assets
March 31, December 31,
2000 1999
------ -----
(unaudited)
Current assets:
<S> <C> <C>
Cash and cash equivalents $ 1,585,000 $ 1,937,000
Accounts receivable 685,000 1,416,000
Inventory 3,893,000 2,188,000
Prepaid expense and other 873,000 153,000
-------------------- -------------------
Total current assets 7,036,000 5,694,000
Property and equipment, net 10,369,000 10,693,000
Inventory 1,533,000 2,454,000
Other assets 370,000 416,000
-------------------- -------------------
Total assets $ 19,308,000 $ 19,257,000
==================== ===================
</TABLE>
See accompanying notes.
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NaPro BioTherapeutics, Inc.
Balance Sheet
Liabilities and Stockholders' Equity
March 31, December 31,
2000 1999
---- ----
(unaudited)
Current liabilities:
<S> <C> <C>
Accounts payable $ 1,955,000 $ 2,174,000
Accrued payroll and payroll taxes 486,000 557,000
Notes payable--current portion 69,000 48,000
-------------------- --------------------
Total current liabilities 2,510,000 2,779,000
Notes payable--long term 6,733,000 4,723,000
------------------- ------------------
Total liabilities 9,243,000 7,502,000
Minority interest 622,000 622,000
Stockholders' equity
Preferred stock, $.001 par value:
Authorized shares--2,000,000
Issued--none (unaudited in 2000) - -
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 (unaudited
in 2000) 3,000 3,000
Common stock, $.0075 par value:
30,000,000 shares authorized
23,737,344 shares issued in 2000 (unaudited),
and 23,482,671 in 1999 178,000 176,000
Additional paid-in capital 66,263,000 65,358,000
Deficit (55,659,000) (52,620,000)
Treasury stock--405,885 shares in 2000 (unaudited)
and 539,837 shares in 1999 (1,342,000) (1,784,000)
------------------- -------------------
Total stockholders' equity 9,443,000 11,133,000
------------------ ------------------
Total liabilities and stockholders' equity $ 19,308,000 $ 19,257,000
================= =================
See accompanying notes.
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NaPro BioTherapeutics, Inc.
Consolidated Operations Statement
(Unaudited)
Three Months Ended
March 31,
2000 1999
<S> <C> <C>
Product Sales $ 733,000 $ 2,037,000
Expense:
Research, development and cost of
products sold 2,116,000 2,811,000
General & administrative 1,574,000 1,222,000
-------------- ------------------
3,690,000 4,033,000
-------------- ------------------
Operating loss (2,957,000) (1,996,000)
License fee - 340,000
Interest income 29,000 75,000
Interest expense (111,000) (176,000)
-------------- -------------------
Loss before extraordinary item (3,039,000) (1,757,000)
Extraordinary item--loss on early
extinguishment of debt - (182,000)
-------------- ------------------
Net loss $ (3,039.000) $ (1,939,000)
============== ==================
Basic and diluted loss per share
Loss before extraordinary item $ ( 0.13) $ (0.10)
Extraordinary item - loss on early
extinguishment of debt - (0.01)
-------------- --------------------
Net loss $ (0.13) $ (0.11)
============== ====================
Weighted average shares outstanding 23,079,691 17,663,429
============== ===================
</TABLE>
See accompanying notes.
5
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<CAPTION>
NaPro BioTherapeutics, Inc.
Consolidated Cash Flow Statement
(Unaudited)
Three Months Ended
March 31,
2000 1999
---- ----
Operating activities
<S> <C> <C>
Net loss $ (3,039,000) $ (1,939,000)
Adjustments to reconcile net loss to net cash
provided (used) by operating activity:
Depreciation 373,000 392,000
Accretion of debt issue cost, warrant allocation
and conversion rights allocation 10,000 94,000
Retirement contributions paid with common stock 221,000 227,000
Interest expense paid with common stock - 6,000
Loss on early retirement of debt - 35,000
Changes in operating assets and liabilities:
Accounts receivable 731,000 (450,000)
Inventory (775,000) 390,000
Prepaid expense and other assets (27,000) 220,000
Accounts payable (219,000) 156,000
Accrued liabilities (71,000) 104,000
Deferred revenue - (1,070,000)
----------------- --------------
Net cash used by operating activity (2,796,000) (1,835,000)
Investing activity
Transfer from restricted cash - 340,000
Additions to property and equipment (58,000) (180,000)
Proceeds from the sale of property & equipment - 12,000
----------------- ---------------
Net cash provided (used) by investing activity (58,000) 172,000
Financing activity
Proceeds from notes payable 2,077,000 66,000
Preferred stock dividend - (46,000)
Payments on notes payable (56,000) (818,000)
Proceeds from exercise of stock options and warrants 481,000 -
----------------- ----------------
Net cash provided (used) by financing activity 2,502,000 (798,000)
Net decrease in cash and cash equivalents (352,000) (2,461,000)
Cash and cash equivalents at beginning of period 1,937,000 7,244,000
----------------- ----------------
Cash and cash equivalents at end of period $ 1,585,000 $ 4,783,000
================ ================
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See accompanying notes.
6
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NaPro BioTherapeutics, Inc. and Subsidiaries
Consolidated Cash Flow Statement
(Unaudited)
Three Months Ended
March 31,
2000 1999
---- ----
Supplemental schedule of activity
<S> <C> <C>
Interest paid $ 105,000 $ 83,000
Noncash transactions:
Conversion of senior convertible debt to common stock - 959,000
Conversion of convertible preferred shares to
common stock - 659,000
Issuance of common stock for compensation
previously accrued - 3,000
Accretion of convertible preferred stock conversion
rights valuation, offering cost and warrant valuation - 38,000
Issuance of common stock to prepay retirement plan
contributions 647,000 898,000
Depletion of plantation cost to inventory 9,000 -
</TABLE>
See accompanying notes.
7
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NaPro BioTherapeutics, Inc.
Notes to Consolidated Financial Statements
March 31, 2000
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. Inventory March 31, December 31,
2000 1999
------------- ----------
Raw materials $ 204,000 $ 129,000
Work-in-process 1,363,000 481,000
Finished goods 2,326,000 1,578,000
---------- ----------
$3,893,000 $2,188,000
========== ==========
Non-current inventory
Raw materials $ 1,533,000 $ 1,562,000
Work-in-process --- 892,000
----------- ----------
$ 1,533,000 $2,454,000
=========== ==========
3. Common Stock
In the March 2000 quarter NaPro issued 84,273 and 170,000 shares of common stock
upon exercise of stock options and warrants, respectively.
In 2000 NaPro issued 133,982 shares of common stock from its treasury to the
Company's retirement plans for use in making the 2000 retirement plan
contributions. In the March 2000 quarter NaPro expensed $216,000 for the portion
of the contributions applicable to the quarter.
4. Loss per Share
The following table sets forth the computation of basic and diluted loss per
share. In calculating diluted earnings per share for the period in which a loss
is reported, the impact of all additional shares is antidulutive, and thus not
included in the calculation.
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<CAPTION>
March 31,
2000 1999
------ -----
Numerator:
<S> <C> <C>
Net loss $ (3,039,000) $ (1,939,000)
Preferred stock dividends - (49,000)
-------------- -------------
Numerator for loss per share - loss
attributable to common stockholders $ (3,039,000) $ (1,988,000)
============== =============
Denominator:
Denominator for loss per share - weighted average
shares 23,079,691 17,663,429
============== ============
Basic and diluted net loss per share $ (0.13) $ (0.11)
============== =============
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5. Extraordinary Item
In January 1999, NaPro redeemed $633,000 in note principal on its senior
convertible notes. NaPro recorded a loss on early extinguishment of debt of
$182,000 which includes a $158,000 premium paid and $24,000 of unamortized debt
issue cost.
6. Abbott Note Payable
During the March 2000 quarter, NaPro borrowed an additional $2 million on the
Abbott Laboratories ("Abbott") note, resulting in a net balance at March 31,
2000 of $6.733 million.
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations
The following discussion and analysis provides information that management
believes is relevant to an assessment and understanding of the results of
operations of NaPro. This discussion should be read in conjunction with the
Financial Statements and Notes included elsewhere in this report. Special Note:
Certain statements set forth below constitute "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act of 1995 (the
"Reform Act"). See "Special Note Regarding Forward Looking Statements."
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 the primary source of
new chemotherapeutic 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
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working internally on several classes of compounds and on targeted delivery
technology, some of which have promising 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 and F.H. Faulding & Co., Ltd. ("Faulding") for the clinical development,
sales, marketing and distribution 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. For the quarter ended
March 31, 2000, NaPro recorded an operating loss of $3 million, resulting in an
accumulated deficit of $55.7 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 biomass procurement, product
development and research and develop ment activities. NaPro anticipates that
operating losses will continue until such time, if ever, as NaPro is able to
generate sufficient revenue to support its operations.
Primarily, NaPro's ability to generate sufficient revenue to support its
operations depends 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 ("FDA"), 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 product 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 (the "Abbott Agreement") 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 will be responsible for supply of bulk drug and may jointly conduct
clinical trials with Abbott. Abbott will be responsible for finishing,
regulatory filings, marketing and sale of the finished 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 a drug development program 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 is increasing and will be significant.
The compound, paclitaxel, is not patented. Bristol-Myers Squibb Co. ("Bristol")
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
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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 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 March
2000 quarter NaPro drew down $2 million on the secured loan.
Contingent upon NaPro's successful achievement of all development milestones and
in addition to the payments received in 1999, NaPro could receive up to $45
million from Abbott consisting of $37 million in development fees and up to $8
million for the purchase of 1.6 million shares of NaPro common stock. In
addition, NaPro will have access to up to a total of $20 million under a secured
loan arrangement with Abbott, including the 1999 draws of $5 million and March
2000 quarter draws of $2 million. 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 are collateralized 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, Abbott will pay a
percentage of its net paclitaxel sales to NaPro, less Abbott's payments to NaPro
for purchase of bulk drug.
Results of Operations
Quarter ended March 31, 2000 compared to the quarter ended March 31, 1999
- -------------------------------------------------------------------------
Sales for the 2000 quarter were $700,000, representing a decrease of $1.3
million from the 1999 quarter. There were no sales to IVAX Corporation ("IVAX")
for the 2000 quarter, down $1 million from the 1999 quarter. Sales to IVAX, as a
result of the Termination Agreement, ended in the September 1999 quarter. In
April 2000 NaPro sold $1.3 million of product. Sales may vary significantly
depending on a number of factors, including the potential, if any, for
commercial sales in the Abbott territory, the timing and size of any clinical
trials, NaPro's obtaining additional strategic partners, changes in demand, the
level of inventory carried and changes in approved markets. This variability
will continue until stable commercial demand has been established for the
product in at least one principal market.
Research, development and cost of product sold expense for the 2000 quarter was
$2,100,000, down $700,000 from the 1999 quarter, primarily because of lower cost
of product sold relating to the lower sales in 2000.
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General and administrative expense for the 2000 quarter was $1.6 million, up
$400,000 from the 1999 quarter. The increase is primarily attributable to
increases in payroll, regulatory consulting and travel.
There was no license fee income for the 2000 quarter. The income in the 1999
quarter related to a license fee paid by IVAX in conjunction with the
Termination Agreement. Under the Termination Agreement, NaPro received the final
license fee payment in the September 1999 quarter.
Interest expense for the 2000 quarter was $100,000, a decrease of $100,000 from
the 1999 quarter. The decrease is attributable to the absence of accretion of
debt issue cost, warrant allocation and conversion rights allocation
attributable to the convertible securities.
There was no extraordinary item for the 2000 quarter. The 1999 item was a loss
on early extinguishment of debt resulting from the early redemption of a portion
of the senior convertible debt.
Liquidity and Capital Resources
NaPro's capital requirements have been and will continue to be significant. As
of March 31, 2000, NaPro had a working capital balance of $4.5 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 $7 million had
been drawn as of March 31, 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 equity securities of approximately $29.5 million, on the
exercise of warrants and options of $6.4 million, on net borrowings of $17.7
million, and on loans and advances from its stockholders and strategic partners.
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,
and may seek other forms of long-term financing should such financing become
available on acceptable terms. 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 closed a private placement of 5,000 shares of Series C
Senior Convertible Preferred Stock (the "C Preferred") 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.
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Working Capital and Cash Flow Cash and cash equivalents decreased $300,000 to
$1.6 million for the quarter ended March 31, 2000 from $1.9 million at December
31, 1999. During the 2000 quarter net cash used by operations of $2.8 million
and used by investment activity of $100,000 was offset by financing activity of
$2.5 million. NaPro currently finances working capital requirements on an
as-needed basis through draws on the Abbott loan.
Inventory increased $800,000 from December 31, 1999 to $5.4 million at March 31,
2000 because of the timing of shipments. 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 $100,000 during the first quarter of 2000
for capital projects. These expenditures primarily included plantation cost and
laboratory equipment.
The amount and timing of future capital expenditures will depend upon numerous
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" within
the meaning of the federal securities laws, including the Reform Act. 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;
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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;
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 availability of qualified personnel generally;
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;
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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;
the effect on NaPro's revenue, cash flow and earnings from foreign exchange
rate fluctuations;
and other factors referenced in this report.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
This information is incorporated by reference to the December 31, 1999 Form
10-K. There have been no material changes in market risk subsequent to such
disclosure.
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 ("BNP")
in the United Kingdom, alleging patent infringement with respect to clinical
trials carried out in the United Kingdom involving paclitaxel. NaPro and BNP
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. It is NaPro's
belief that this appeal will be decided sometime during 2000. 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 Court of Appeal ruling, to be low. In addition, BNP 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.
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Item 2. Changes in Securities
On December 8, 1997, NaPro closed a private placement of 5,000 shares of Series
C Senior Convertible Preferred Stock (the "C Preferred") for an aggregate
issuance price of $5 million. NaPro also issued 175,000 common stock warrants as
part of this transaction. On February 16 and February 17, 2000, NaPro issued
170,000 shares of common stock upon exercise of warrants. As an issuance to a
single sophisticated investor not involving any public offering, the issuance of
common stock upon exercise of common stock warrants was exempt under Section
4(2) of the Securities Act and Regulation D thereunder.
On February 17, 2000 and March 2, 2000, NaPro issued 5,000 and 6,000 shares of
common stock, respectively, upon exercise of stock options by former directors.
As issuances to accredited investors not involving any public offering, the
issuances were exempt under Section 4(2) of the Securities Act and Regulation D
thereunder. These issuances upon the exercise of compensatory stock options
granted before NaPro was a reporting company under the Securities Exchange Act
of 1934, as amended (the "Exchange Act"), were also exempt under Rule 701 under
the Securities Act.
Item 3. Defaults upon Senior Securities. None.
Item 4. Submission of Matters to a Vote of Securities Holders. None
Item 5. Other Information. None.
Item 6. Exhibits and Reports on Form 8-K
NaPro filed no current reports on Form 8-K during the quarter.
Exhibit
Number Description of Exhibit
27.1 Financial Data Schedule
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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.
May 12, 2000 /s/ Leonard P. Shaykin
Leonard P. Shaykin
Chairman of the Board
Chief Executive Officer
May 12, 2000 /s/ Gordon H. Link, Jr.
Gordon H. Link, Jr.
Vice President
Chief Financial Officer
(Principal Financial Officer)
May 12, 2000 /s/ Robert L. Poley
Robert L. Poley
Controller
(Principal Accounting Officer)
17
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