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
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