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Bone Care International, Inc. Reports First Quarter FY 2004 Financial Results
- Quarterly Sales of Hectorol(R) Reach Record $8.1 Million Achieving an Increase
of 50 Percent -
MIDDLETON, Wis., Oct. 27 /PRNewswire-FirstCall/ -- Bone Care International,
Inc. today announced financial results for the first fiscal quarter of 2004
ended September 30, 2003. The company reported record quarterly sales for
Hectorol(R) (doxercalciferol) of $8.1 million, compared to Hectorol(R) sales of
$5.4 million for the first quarter of 2003, representing a 50 percent increase
in the first quarter of 2004 compared with the same period in 2003.
The net loss for the first quarter of 2004 was $2.1 million, or $0.15 per common
share, compared with a net loss for the first quarter of 2003 of $1.6 million,
or $0.12 per common share. The company ended the first quarter of 2004 with a
total of $14.2 million in cash and short and long-term investments.
"Bone Care International's strong financial and operational results this quarter
directly reflect the tremendous efforts of our employees and their commitment to
patients," said Paul L. Berns, President and Chief Executive Officer. "In
addition to the 50 percent sales increase from the first quarter of last year,
sales increased by $800,000, or 12 percent, from the previous quarter ended June
30, 2003. Also, in accordance with our plan, we continued to build inventory
levels to accommodate the increased patient and customer demand for Hectorol(R)
with many wholesalers reporting a lower than normal supply of inventory at the
end of September. We are focused on quarter-over-quarter sales growth as we
progress toward our goal of profitability in the June 2004 quarter."
Some of the first quarter highlights included:
* The submission of an Investigational New Drug application (IND) for LR-
103. The initial Phase I study in approximately 30 oncology patients
will be conducted by the University of Wisconsin and is planned to
begin before the end of 2003. This dose-ranging study is designed to
assess the tolerability and pharmacokinetic profile of oral LR-103
following single and multiple dose administration.
* The strengthening of the management team with the addition of Brian J.
Hayden as Chief Financial Officer.
* Continued pursuit of FDA approval of the supplemental New Drug
Application (sNDA) for Hectorol(R) Capsules for the treatment of
secondary hyperparathyroidism in patients with chronic kidney disease
(CKD) prior to dialysis. This new indication for Hectorol(R) could
address an unmet medical need among the estimated 7.6 million Stage 3
CKD patients and the 400,000 Stage 4 CKD patients.
The company reiterated its prior guidance that it expects fiscal year 2004 sales
from Hectorol(R) to range between $35 million to $40 million and the transition
to profitability is targeted for the fourth quarter of FY2004.
Management will host a conference call on Tuesday, October 28, 2003, at 9:00
a.m. CDT. The toll-free number within North America is (888) 694-4728; the
dial-in number for international participants is (973) 935- 8513. The call is
available for playback until midnight on October 31, 2003 at (877) 519-4471
within North America and at (973) 341-3080 for international callers. The
playback pass code is 4245309. The call can also be accessed via webcast and
will be archived for playback at http://www.bonecare.com/conferencecall.
Bone Care International (http://www.bonecare.com/) is a specialty pharmaceutical
company engaged in discovering, developing and commercializing improved vitamin
D-hormone therapies to treat secondary hyperparathyroidism in patients with
kidney or renal disease and other diseases including osteoporosis, psoriasis and
cancers of the prostate, breast and colon. Hectorol(R) Injection and
Hectorol(R) Capsules are being marketed for the treatment of secondary
hyperparathyroidism in patients with end stage renal disease (Stage 5 chronic
kidney disease).
Contacts:
Rx Communications Group, LLC Bone Care International, Inc.
Melody A. Carey (Investors) Brian J. Hayden
(917) 322-2571 Chief Financial Officer
Pete Holmberg (Media) (608) 662-7800
(917) 322-2164
This press release contains forward-looking statements. Statements relating to
future sales, costs of sales, other expenses, profitability, financial
resources, or products and production schedules, or statements that predict or
indicate future events and trends and which do not relate solely to historical
matters identify forward-looking statements. Forward-looking statements are made
pursuant to the safe harbor provisions of Section 27A of the Securities Act of
1933 and Section 21E of the Securities Exchange Act of 1934 and are based on
management's beliefs as well as assumptions made by and information currently
available to management. Accordingly, the Company's actual results may differ
materially from those expressed or implied in such forward-looking statements
due to known and unknown risks and uncertainties that exist in the Company's
operations and business environment, including, among other factors, the ability
of the Company and each of its suppliers of doxercalciferol, Hectorol(R)
Injection and Hectorol(R) Capsules to meet the Company's anticipated production
schedules, technical risks associated with the development of new products,
regulatory policies in the United States and other countries, risks associated
with our ability to avoid or minimize delays in/or interruption of the
manufacture and supply of our products, including the approvals of regulatory
authorities in connection therewith, reimbursement policies of public and
private health care payors, introduction and acceptance of new drug therapies,
competition from existing products and from new products or technologies, the
failure by the Company to produce anticipated cost savings or improve
productivity, the timing and magnitude of capital expenditures and acquisitions,
currency exchange risks, economic and market conditions in the United States,
Europe and the rest of the world, and other risks associated with the Company's
operations. The Company disclaims any obligation to update any such factors or
to publicly announce any revisions to any of the forward-looking statements
contained herein to reflect future events or developments.
Bone Care International, Inc.Condensed Statements Of Operations
(Unaudited)
For the Three Months Ended,
September 30, September 30,
2003 2002
PRODUCT SALES $8,125,042 $5,417,400
COST AND OPERATING EXPENSES:
Cost of product sales 2,417,644 1,509,606
Research and development 1,793,160 1,676,624
Selling, general and administrative 6,081,199 4,077,088
10,292,003 7,263,318
Loss from operations (2,166,961) (1,845,918)
INTEREST INCOME, net 64,909 214,780
NET LOSS $(2,102,052) $(1,631,138)
Basic and diluted net loss per common share $(0.15) $(0.12)
Shares used in computing basic and diluted net
loss per common share 14,240,725 14,156,772
Certain prior period amounts in the financial statements have been
reclassified to conform to the fiscal 2004 presentation.
BONE CARE INTERNATIONAL, INC.
CONDENSED BALANCE SHEETS
(Unaudited)
September 30, 2003 June 30, 2003
ASSETS
CURRENT ASSETS
Cash, cash equivalents and
marketable securities $13,292,730 $16,690,044
Accounts receivable, net 3,343,632 2,814,753
Inventory 2,740,967 2,080,604
Other current assets 966,692 778,725
Total current assets 20,344,021 22,364,126
OTHER ASSETS 4,445,885 4,484,236
$ 24,789,906 $ 26,848,362
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES $5,986,692 $5,755,890
LONG-TERM LIABILITIES - 649,880
SHAREHOLDERS' EQUITY
Common stock 74,103,475 73,640,801
Accumulated deficit (55,300,261) (53,198,209)
Total shareholders' equity 18,803,214 20,442,592
$24,789,906 $26,848,362
DATASOURCE: Bone Care International, Inc.
CONTACT: Melody A. Carey (Investors), +1-917-322-2571 or Pete Holmberg
(Media), +1-917-322-2164, both of Rx Communications Group, LLC, for Bone Care
International, Inc.; Brian J. Hayden, Chief Financial Officer of Bone Care
International, Inc., +1-608-662-7800
Web site: http://www.bonecare.com/
http://www.bonecare.com/conferencecall