Inkine Pharmaceutical (NASDAQ:INKP)
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From Oct 2019 to Oct 2024
InKine Pharmaceutical Company, Inc. (NASDAQ:INKP):
-Highlights-
-- Completed Phase III Clinical Study and Submitted a New Drug
Application to FDA for Approval of INKP-102
-- Grew Quarterly Revenues by 30% to $6.0 Million for Q1 2005,
Compared to $4.6 Million for Q1 2004
-- Generated Fourth Consecutive Quarter of Profitability
-- Earned Milestone for Development of Visicol(R) for Sale in
Japan
-- Revised 2005 Annual Guidance Based on Year-to-Date
Prescription Growth Trends
InKine Pharmaceutical Company, Inc. (Nasdaq: INKP) today announced
its first quarter 2005 financial results, reporting first quarter
revenue of $6.0 million, compared to $4.6 million for the same period
a year ago. The Company generated EPS of $0.01 per share for the
quarter, compared to an EPS of $0.00 for the same period a year ago.
Current quarter EPS was achieved during the quarter where increased
research and development resources were invested to accelerate the
development of INKP-102, the Company's next generation purgative for
which a new drug application (NDA) was recently submitted to the FDA.
"We are pleased to announce our fourth consecutive quarter of
profitability," said Leonard S. Jacob, M.D., Ph.D., Chairman and Chief
Executive Officer of InKine. "Product revenue increased by 20%
compared to the first quarter of 2004, despite the entrance of two new
products into the purgative marketplace. Our sales and marketing team
has been aggressively combating these new competitors with success.
Extensive competitor sampling and physician trial has impacted our
product revenue growth trends, decreasing the prescription growth from
a prior year average of approximately 35% to current quarter growth of
approximately 27%," added Dr. Jacob. "On the development front, we
also announced today that we submitted an NDA to the FDA for our new
generation purgative tablet, INKP-102. We are excited about our study
results and look forward to bringing to market what we believe will be
the best purgative on the market," Dr. Jacob further added.
Product Sales:
-- Product revenues for the first quarter of 2005 were $5.2
million, a 20% increase over product revenues of $4.4 million
for the same period a year ago. Prescription levels have
escalated as a result of increased sales and marketing
efforts, which continue to grow market awareness and
acceptance of Visicol(R). Approximately 133,000 prescriptions
were filled for Visicol(R) during the first quarter of 2005,
which represents approximately a 27% increase over
prescriptions of 105,000 for the first quarter of 2004.
-- In addition to product revenue, the Company realized $818,000
in other revenue for the first quarter of 2005, which was
primarily attributable to a milestone payment earned from
Zeria Pharmaceutical Company, the licensee for Visicol(R)'s
use and sale in Japan.
"Our sales and marketing team is committed to growing Visicol(R)
and overcoming both new and previously existing competitors," said
Robert F. Apple, Chief Operating and Financial Officer of InKine. "We
intend to continue to carefully manage our development and growth
initiatives by making resource investment in key areas that will
return shareholder value. We believe that the resources deployed for
our sales and marketing initiatives, INKP-102 development and NDA
preparation will yield increased shareholder value in the medium and
long-term. We believe that the growth in our sales force today will
yield significant value as we prepare for the launch of INKP-102 in
2006," added Mr. Apple.
Costs and Expenses:
-- Research and development costs were $1.8 million for the first
quarter of 2005, compared to $0.9 million for the same period
a year ago. The increase was the result of development costs
associated with the clinical studies and NDA submission of the
Company's next generation MCC-free purgative tablet, INKP-102.
A significant portion of these costs have and will occur in
the first two quarters of 2005 as the INKP-102 development
program is currently winding down.
-- Sales and marketing costs were $2.3 million for the first
quarter of 2005, compared to $1.9 million for the same period
a year ago. The increase was the result of continued growth in
the size of the Company's sales force, along with increased
marketing campaigns related to Visicol(R). As of March 31,
2005, the Company's sales force covered 48 territories with
five district managers, compared to 45 territories and four
district managers as of March 31, 2004.
-- General and administrative costs were $0.9 million for the
first quarter of 2005, compared to $0.8 million for the same
period a year ago. The increase was the result of higher
personnel, patent and insurance costs resulting from increased
overhead costs associated with supporting a growing sales
volume, and head count, along with increased legal and
accounting fees associated with maintaining compliance with
the Sarbanes-Oxley Act of 2002.
Balance Sheet:
-- The Company had $10.6 million in cash and investments at March
31, 2005.
Revised Guidance:
-- The Company had previously guided the investor community that
it expected that 2005 product revenues would be in the range
of $28 million to $32 million. Based upon information
currently available, the Company has revised its revenue
guidance to a range of $23 million to $27 million. The
reduction in 2005 product revenue guidance is principally due
to the recently experienced slowing in the growth trend for
Visicol(R) prescriptions, which Company management believes
has been caused by the emergence of the new product
competitors to the purgative marketplace.
-- Based upon information currently available, the Company may
postpone or slow certain development programs in the second
half of 2005 in order to maintain profitability and positive
cash flow for the 2005-year. The postponement and slowing of
these programs could result in a reduction of research and
development expense for 2005 of up to $2.0 million. The
Company had previously guided the investor community that it
expects to incur approximately $6.5 million to $7.0 million in
research and development expenses.
-- The Company had previously guided the investor community that
it expects to incur approximately $0.7 million to $0.9 million
in equity compensation costs related to option and restricted
stock grants under its equity compensation plans. As a result
of the recent postponement of the required SFAS 123R adoption
date from July 1, 2005 to January 1, 2006, the Company expects
to incur equity compensation costs in the range of
approximately $0.2 million to $0.3 million for 2005.
-- The Company had previously guided the investor community that
it expected that 2005 EPS would be in the range $0.08 to $0.11
per share. Based upon information currently available, 2005
earnings per share is expected be in the range of $0.06 to
$0.09 per share.
The Company will be hosting a conference call today at 11:00 AM
EDT to further discuss the first quarter 2005 financial results. To
participate please dial (877) 407-8029 about five to ten minutes prior
to the initiation of the teleconference. The conference call will also
be available on replay starting at 1:00 PM EDT on May 3, 2005, and
ending at 5:00 PM EDT on May 10, 2005. For the replay, please dial
(877) 660-6853 (replay account # 2658, replay conference # 148664).
The access number for the replay for international callers is (201)
612-7415 (replay account # 2658, replay conference # 148664).
About InKine Pharmaceutical
InKine Pharmaceutical Company, Inc. is a publicly traded specialty
pharmaceutical company focused on developing and commercializing
pharmaceutical products for the diagnosis and treatment of
gastrointestinal disorders. The Company's development strategy is to
acquire late-stage drug candidates with short time lines to
commercialization. The Company's franchise product, Visicol(R) is the
only tablet purgative preparation indicated for bowel cleansing prior
to colonoscopy. InKine's second product, IB-Stat(R), is an oral
hyoscyamine spray for the treatment of a variety of indications.
Additionally, the Company is developing INKP-102, an advanced
generation purgative, which we recently submitted a new drug
application to FDA for bowel cleansing prior to colonoscopy and
studying Visicol(R) for use as a laxative in treating patients with
chronic constipation. For further information, please visit InKine on
its web site http://www.inkine.com.
This press release contains forward-looking statements, including
statements regarding our expectations regarding INKP-102, our
development programs, our financial performance and our ability to
increase shareholder value. Such forward-looking statements are based
on InKine's current expectations or forecasts of future events.
InKine's performance and financial results could differ materially
from those reflected in these forward-looking statements due to
general financial, economic, regulatory and political conditions
affecting the biotechnology and pharmaceutical industries, market
acceptance of product introductions by InKine's competitors, InKine's
success in implementing sales and marketing changes and the effects of
the other risks and uncertainties set forth in InKine's reports on
Form 10-Q and 10-K filed with the U.S. Securities and Exchange
Commission. Given these risks and uncertainties, any or all of these
forward-looking statements may prove to be incorrect. Therefore, you
should not rely on any such factors or forward-looking statements.
Furthermore, InKine may elect to update forward-looking statements,
but the Company disclaims any obligation to do so.
-0-
*T
InKine Pharmaceutical Company, Inc.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS
(amounts in thousands, except per share)
(unaudited)
Quarter Ended March 31,
-------------------------
2005 2004
------------ ------------
Product revenue $ 5,218 $ 4,350
Other revenue 818 283
------------ ------------
Total revenue 6,036 4,633
Cost of goods sold (848) (491)
------------ ------------
Gross profit 5,188 4,142
Research and development 1,769 922
Sales and marketing 2,288 1,949
General and administrative 877 785
Withdrawn public offering and litigation - 567
------------ ------------
Operating expenses 4,934 4,223
------------ ------------
Operating income (loss) 254 (81)
Interest income and expense 60 3
------------ ------------
Net income (loss) $ 314 $ (78)
============ ============
Earnings per share - Basic and diluted $ 0.01 $ -
============ ============
Weighted average shares outstanding:
Basic 49,095 48,547
Diluted 53,459 48,547
March 31, December 31,
2005 2004
------------ ------------
(unaudited)
ASSETS
------
Cash and investments $ 10,562 $ 13,053
Accounts receivable 4,196 2,264
Inventory 1,905 1,445
Other assets 911 622
------------ ------------
Total assets $ 17,574 $ 17,384
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
------------------------------------
Accounts payable and accrued expenses $ 2,776 $ 3,016
Shareholders' equity 14,798 14,368
------------ ------------
Total liabilities and shareholders'
equity $ 17,574 $ 17,384
============ ============
*T