EXHIBIT 99.1
BONE CARE INTERNATIONAL REPORTS RECORD FOURTH QUARTER PRODUCT SALES OF $7.3
MILLION
FISCAL 2004 PRODUCT SALES GUIDANCE OF $35-40 MILLION
COMPANY TARGETS FOURTH QUARTER FISCAL 2004 TRANSITION TO PROFITABILITY
ONCOLOGY IND FILING PLANNED FOR LEAD PIPELINE PRODUCT IN SEPTEMBER
Middleton, Wis., July 28, 2003 -- Bone Care International, Inc.
(Nasdaq: BCII) a specialty pharmaceutical company engaged in the discovery,
development and commercialization of improved vitamin-D hormone therapies,
announced today that revenues for the three months ended June 30, 2003 increased
54 percent to $7.3 million, compared to $4.7 million for the same quarter in
2002. Revenues for the fiscal year ended June 30, 2003 increased 30 percent to
$19.5 million, compared to $15.0 million in the fiscal year ended June 30, 2002.
Bone Care reported a net loss of $1.3 million, or $0.09 per share, for
the three months ended June 30, 2003, compared to a net loss of $1.7 million, or
$0.12 per share, for the same quarter in 2002. The net loss for the fiscal year
ended June 30, 2003 was $11.7 million, or $0.82 per share, compared to a net
loss of $6.9 million, or $0.49 per share, for the fiscal year ended June 30,
2002.
The Company reiterated prior guidance that it currently expects to
increase revenues from product sales to grow to approximately $35 to $40 million
in the fiscal year ended June 30, 2004. Bone Care currently targets a transition
to profitability by the fourth quarter of fiscal 2004.
"We are particularly encouraged by the revenue growth in the June
quarter as it reflects our first full quarter of sales for Hectorol(R)
(doxercalciferol) Injection since the re-launch," said Paul L. Berns, President
and Chief Executive Officer of Bone Care. "The vast majority of our established
customers demonstrated their support for Hectorol Injection by placing orders in
the June quarter. Fourth quarter sales were primarily driven by current patient
and customer demand, with many wholesalers reporting a lower than normal supply
of inventory at the end of June. Going forward, we anticipate meeting existing
and new patient customer demand while building the wholesaler inventory levels."
Bone Care is also working with the FDA in regards to its supplemental
New Drug Application (sNDA) for Hectorol Capsules. The sNDA proposes a new
indication, the treatment of secondary hyperparathyroidism in chronic kidney
disease (CKD) patients prior to dialysis.
"The new indication for the treatment of pre-dialysis CKD presents a
significant opportunity to provide care for the estimated 7.6 million Stage 3
and 400,000 Stage 4 patient populations," Mr. Berns continued. "We currently
anticipate that FDA approval could occur by
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the end of calendar 2003 and commercial launch shortly thereafter. In
expectation of approval, we are actively exploring potential partnerships for
the co-promotion of this product."
Bone Care also announced that it plans to submit an Investigational New
Drug application (IND) for its lead pipeline product, LR-103. The IND is
scheduled to be submitted in the third quarter of this calendar year. The
initial Phase I study in approximately 30 oncology patients will be conducted
through the University of Wisconsin in Madison, beginning in the fourth quarter
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.
Management will host a conference call on July 29, 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) 582- 2720. The call is available
for playback until midnight on August 1, 2003 at (877) 519-4471 within North
America and at (973) 341-3080 for international callers. The playback pass code
is 4030231. The call can also be accessed via webcast and will be archived for
playback at www.bonecare.com/conferencecall.
Bone Care (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 Injection and Hectorol
Capsules are approved for the treatment of secondary hyperparathyroidism in
patients with end stage renal disease (Stage 5 chronic kidney disease).
CONTACT: Robert Beckman
Vice President -- Finance and Investor Relations
Bone Care International, Inc.
TEL: 608-622-7815
Email: bbeckman@bonecare.com
This press release contains forward-looking statements. Statements relating to
future net 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 its supplier of Hectorol Injection to meet the Company's
anticipated production schedule, 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.
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BONE CARE INTERNATIONAL, INC.
Statements of Operations
THREE MONTHS ENDED, TWELVE MONTHS ENDED,
------------------------------- -------------------------------
JUNE 30, JUNE 30, JUNE 30, JUNE 30,
2003 2002 2003 2002
------------ ------------ ------------ ------------
Revenues $ 7,279,839 $ 4,731,920 $ 19,518,274 $ 14,990,749
Operating expenses:
Cost of sales 2,486,557 1,280,013 6,983,175 3,556,687
Research and development 1,465,412 1,459,699 6,018,693 5,739,152
Sales and marketing 3,409,861 3,028,860 13,433,861 10,275,913
Administrative 1,306,704 958,860 5,334,913 3,580,063
------------ ------------ ------------ ------------
8,668,534 6,727,432 31,770,642 23,151,815
------------ ------------ ------------ ------------
Loss from operations (1,388,695) (1,995,512) (12,252,368) (8,161,066)
Interest income 94,314 262,347 574,395 1,257,171
------------ ------------ ------------ ------------
Loss before income tax (1,294,381) (1,733,165) (11,677,973) (6,903,895)
Income tax expense - - - -
------------ ------------ ------------ ------------
Net loss $ (1,294,381) $ (1,733,165) $(11,677,973) $ (6,903,895)
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Weighted average common shares outstanding
14,215,846 14,154,312 14,174,594 14,084,313
Net loss per common share $ (0.09) $ (0.12) $ (0.82) $ (0.49)
============ ============ ============ ============
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BONE CARE INTERNATIONAL, INC.
Condensed Balance Sheets
JUNE 30, 2003 JUNE 30, 2002
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ASSETS
Current Assets:
Cash and cash equivalents $ 3,065,218 $ 2,023,969
Marketable securities 13,624,826 18,436,896
Accounts receivable, net of allowance for doubtful accounts of
$111,200 and $152,960 at June 30, 2003 and June 30, 2002, 2,814,753 4,285,569
respectively
Inventories 2,080,604 2,099,469
Other current assets 778,725 775,596
----------- -----------
Total current assets 22,364,126 27,621,499
Long-term securities 913,401 3,719,796
Property, plant, and equipment -- at cost:
Leasehold improvements 588,632 588,632
Furniture and fixtures 545,547 452,345
Machinery and other equipment 3,100,108 2,317,405
----------- -----------
4,234,287 3,358,382
Less accumulated depreciation and amortization 2,345,287 1,573,497
----------- -----------
1,889,000 1,784,885
Patent fees, net of accumulated amortization of $1,131,952 at June 30,
2003 and $988,026 at June 30, 2002 1,322,670 1,198,249
Goodwill, net of accumulated amortization of $1,000,752 as of June 30,
2003 and June 30, 2002 359,165 359,165
----------- -----------
$26,848,362 $34,683,594
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BONE CARE INTERNATIONAL, INC.
Condensed Balance Sheets
Liabilities and Shareholders' Equity
JUNE 30, 2003 JUNE 30, 2002
------------- -------------
Current Liabilities:
Accounts payable $ 2,684,838 $ 1,769,665
Accrued liabilities
Compensation payable 2,028,783 509,677
Accrued clinical study and research costs 603,048 152,352
Accrued health and dental costs 101,863 -
Other 738 1,924
Allowance for sales returns 336,620 226,100
------------ ------------
Total current liabilities 5,755,890 2,659,718
Long-term liabilities 649,880 -
Shareholders' equity:
Preferred stock -- authorized 2,000,000 shares of $.001 par value;
none issued - -
Common stock -- authorized 28,000,000 shares of no par value: issued
and outstanding 14,218,522 at June 30, 2003 and 14,156,722 at
June 30, 2002 11,393,883 11,393,883
Additional paid-in capital 62,246,918 62,096,272
Accumulated deficit (53,198,209) (41,520,236)
Accumulated other comprehensive income (loss) - 53,957
------------ ------------
Total shareholders' equity 20,442,592 32,023,876
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$ 26,848,362 $ 34,683,594
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