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FORM 10-Q/A
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Quarterly Report under Section 13 of the
Securities Exchange Act of 1934
For the quarter ended March 31,1997
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 April 18, 1997:
Common Stock, $.0075 par value 11,971,537
Non-voting Common Stock, $.0075 par value 395,000
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Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations
The following discussion and analysis provide information which the Company'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 the Company's
Annual Report on Form 10-K for the year ended December 31, 1996.
General
NaPro is a natural product pharmaceutical company which is focusing primarily on
the development, manufacture and commercialization of paclitaxel, a naturally-
occurring anti-cancer agent found in certain species of yew (Taxus) trees. The
Company's paclitaxel is referred to herein as "NBT Paclitaxel."
NaPro has devoted its efforts primarily to the development and implementation of
its proprietary extraction, isolation and purification (EIP/TM/) technology for
producing NBT paclitaxel. NaPro is currently dependent exclusively on sales of
NBT paclitaxel for revenue. To advance the development and commercialization of
NBT Paclitaxel, NaPro has entered into 20-year, exclusive agreements with each
of F.H. Faulding & Co., Ltd. ("Faulding") and Baker Norton Pharmaceuticals, a
subsidiary of IVAX Corporation ("IVAX" and together with Faulding, the
"Strategic Partners") for the clinical development, sales, marketing and
distribution of NBT Paclitaxel. Through March 31, 1997, NaPro's production of
NBT paclitaxel was limited primarily to research and pilot-scale production, and
much of NaPro's product sales were for use in clinical trials and for research
and development purposes. Accordingly, NaPro has generated only limited revenue
from such activities and has incurred significant operating losses, including
operating losses of approximately $6 million, $4.3 million and $7.1 million for
the years ended December 31, 1994, 1995 and 1996, respectively, and $2.9 million
for the quarter ended March 31, 1997, resulting in an accumulated deficit of
$28.4 million as of March 31, 1997. 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-development 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. NaPro believes that its
ability to generate such revenue depends primarily on the ability of IVAX to
obtain regulatory approval in the U.S. for the commercial sale of NBT
paclitaxel, on NaPro's ability to obtain regulatory approval for its
manufacturing facilities and on NaPro's ability to construct manufacturing
facilities that produce quantities of NBT paclitaxel sufficient to supply the
Strategic Partners' requirements for commercial sales. Moreover, NaPro's future
growth and profitability will depend on the success of the Strategic Partners in
fostering acceptance in the oncological market for NBT paclitaxel as a preferred
form of chemotherapy to be used alone or in combination with other
chemotherapeutic agents.
Results of Operations
Three months ended March 31, 1997 compared to the three months ended March 31,
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1996
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Revenue for the three months ended March 31, 1997 was $1 million, representing
an increase of $300,000 from the three months ended March 31, 1996. All sales in
both quarters were to nonaffiliates of the Company. The increase related
primarily to the timing of product shipments. Shipments to the Strategic
Partners may vary significantly on a quarter to quarter basis depending on a
number of factors, including the timing and size of any clinical trials
conducted by either company and changes in approved markets. This quarter to
quarter variability will continue until stable commercial demand has been
established for the product in one of the Company's major markets.
Research and development and cost of products sold expense for the three months
ended March 31, 1997 was $2.4 million, representing an increase of $600,000 from
the three months ended March 31, 1996. The increase resulted from an increase
in the level of process development and research expense as well as higher
production cost. NaPro's production process is not distinct from its research
and development processes. Accordingly, the cost of products sold is included
with NaPro's research and development expense.
General and administrative expense for the three months ended March 31, 1997 was
$1.5 million, an increase of $800,000 from the three months ended March 31,
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1996. The increase is primarily attributable to a $300,000 increase in
administrative and support staff and a $300,000 increase in legal expense. The
legal expense was incurred in anticipation of the revocation proceeding
instituted by NaPro as described under Part II, Item 1, Legal Proceedings.
Interest income for the three months ended March 31, 1997 was $200,000,
representing an increase of $100,000 from the three months ended March 31, 1996.
The increase is attributable to increased cash balances associated with the
completion of the Company's offering of common stock in August 1996 and its
warrant call completed in June 1996 (See Liquidity and Capital Resources).
Interest and other expense for the three months ended March 31, 1997 was
$100,000, approximately unchanged from the three months ended March 31, 1996.
Liquidity and Capital Resources
NaPro's capital requirements have been and will continue to be significant. At
March 31, 1997, NaPro had working capital of $8.9 million. This compared to a
working capital balance of $14.2 million as of December 31, 1996. 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 $22.8 million,
on the exercise of warrants and options of $4.3 million, and on capital leases,
loans and advances from its stockholders and the Strategic Partners.
Cash and cash equivalents totaled $2.9 million at March 31, 1997. During the
first three months of 1997, cash used by operating, investing, and financing
activities totaled $3.3 million, $3.2 million and $100,000, respectively. In
addition, NaPro had securities held to maturity of $3.3 million, with maturity
dates ranging from April 1997 to June 1997 and securities available for sale of
$2.7 million, with maturity dates ranging from December 1997 to May 1998.
NaPro expended $2.5 million for capital projects during the first three months
of 1997. In 1997, NaPro expects to invest capital in property, plant, and
equipment, primarily to expand its plantation operations, to complete the large
scale commercial EIP/TM/ manufacturing facility in Boulder and to upgrade and
expand its extraction manufacturing capabilities.
NaPro anticipates a significant increase in capital expenditures and operations
in 1997 in anticipation of possible approval of the New Drug Application filed
with the U.S. Food and Drug Administration. Therefore, NaPro will need to obtain
additional capital during the year in the form of debt, equity, corporate
partnering or some combination thereof. If NaPro is not successful in
attracting capital, it will need to reduce significantly the scope of capital
expenditures and operations.
The amount and timing of future capital expenditures will depend upon numerous
factors, including 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, changes in
or terminations of existing strategic partnerships, the establishment of
additional strategic relationships and the cost of manufacturing scale-up.
NaPro may seek additional long-term financing to fund capital expenditures
should such financing become available on terms acceptable to NaPro.
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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 15, 1997 By:/s/ Gordon Link
Gordon Link
Vice President and Chief Financial Officer
(Principal Financial Officer)
