EXHIBIT 99.1
BONE CARE INTERNATIONAL, INC. REPORTS SECOND QUARTER
FY 2004 FINANCIAL RESULTS
- -- QUARTERLY SALES OF HECTOROL(R) REACH RECORD $9.1 MILLION --
- -- COMPANY RAISES SALES GUIDANCE RANGE $38-$40 MILLION --
Middleton, Wis., January 28, 2004 - Bone Care International, Inc.
(Nasdaq: BCII) today announced financial results for the second fiscal quarter
of 2004, ended December 31, 2003. The Company reported record quarterly sales
for Hectorol(R) (doxercalciferol) of $9.1 million, compared to Hectorol(R) sales
of $3.7 million for the second fiscal quarter of 2003, representing an increase
of $5.4 million, or 144 percent. Sales of Hectorol(R) were $17.2 million for the
first six months of fiscal 2004, an increase of $8.1 million, or 88 percent from
the same period of fiscal 2003.
The net loss for the second fiscal quarter of 2004 was $478,025, or
$0.03 per common share, compared with a net loss for the second fiscal quarter
of 2003 of $4.1 million, or $0.29 per common share. The net loss for the first
six months of fiscal 2004 was $2.6 million, or $0.18 per common share, compared
with a net loss of $5.8 million, or $0.41 per common share for the same period
of fiscal 2003. The Company ended the second fiscal quarter of 2004 with a total
of $11.9 million in cash and short and long-term investments.
"This has been a very productive quarter for Bone Care International
with strong Hectorol(R) revenue growth, advances in our research and development
efforts, and continued regulatory progress with our supplemental new drug
application (sNDA) for Hectorol(R) Capsules targeted for the pre-dialysis
chronic kidney disease (CKD) market," said Paul L. Berns, President and Chief
Executive Officer. "We are encouraged with our quarter over quarter sales
performance, represented by a $1.0 million or 12 percent increase, and are
pleased to report our third consecutive quarter of double-digit sales growth.
Additionally, we continued to produce product supply levels to accommodate the
increased patient and customer demand for Hectorol(R) with many wholesalers
reporting lower than normal pipeline levels at the end of December. Our results
are indicative of the efforts of our employees at Bone Care and their
dedication, passion, and hard work in providing important therapies for
patients."
Second quarter highlights include:
o Continued progress with clinical development programs, including
the recent investigational new drug (IND) application acceptance
for LR-103 by the Food & Drug Administration (FDA). The initial
Phase I study in approximately 30 oncology patients will be
conducted by the University of Wisconsin. Additionally, the Company
continues to establish clinical research collaborations with
national dialysis provider groups to conduct studies to further
reinforce Hectorol's(R) unique profile and clinical utility.
o Proactively working with FDA during the regulatory review cycle for
the Company's sNDA for Hectorol(R) Capsules. This potential new
indication for the treatment of secondary hyperparathyrodism in
patients with chronic kidney disease prior to dialysis, 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 increased the lower end of its prior sales guidance and now
expects fiscal year 2004 Hectorol(R) sales to range from $38 million to $40
million. The Company also reiterated its target to achieve profitability in the
fourth quarter of fiscal year 2004.
Management will host a conference call on Thursday, January 29, 2004,
at 9:00 a.m. CST. 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 February 1, 2004 at (877) 519-4471
within North America and at (973) 341-3080 for international callers. The
playback pass code is 4438620. The call can also be accessed via webcast and
will be archived for playback at www.bonecare.com/conferencecall.
Bone Care International (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 CKD).
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, For the Six Months Ended,
------------------------------ --------------------------------
December 31, December 31, December 31, December 31,
2003 2002 2003 2002
------------ ------------ ------------ ------------
PRODUCT SALES $ 9,115,485 $ 3,743,013 $ 17,240,527 $ 9,160,413
COST AND OPERATING EXPENSES:
Cost of product sales 2,431,108 1,459,838 4,848,752 2,969,444
Research and development 1,653,228 1,693,892 3,446,388 3,370,515
Selling, general and administrative 5,546,350 4,869,290 11,627,549 8,946,378
------------ ------------ ------------ ------------
9,630,686 8,023,020 19,922,689 15,286,337
------------ ------------ ------------ ------------
Loss from Operations (515,201) (4,280,007) (2,682,162) (6,125,924)
INTEREST INCOME, net 37,176 152,312 102,085 367,091
------------ ------------ ------------ ------------
NET LOSS $ (478,025) $ (4,127,695) $ (2,580,077) $ (5,758,833)
============ ============ ============ ============
Basic and diluted net loss per common share $ (0.03) $ (0.29) $ (0.18) $ (0.41)
============ ============ ============ ============
Shares used in computing basic and diluted
net loss per common share 14,300,232 14,157,425 14,270,479 14,157,099
============ ============ ============ ============
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)
DECEMBER 31, 2003 JUNE 30, 2003
----------------- -------------
ASSETS
CURRENT ASSETS
Cash, cash equivalents and marketable securities $ 10,978,366 $ 16,690,044
Accounts receivable, net 3,259,476 2,814,753
Inventory 5,181,764 2,080,604
Other current assets 1,310,191 778,725
------------ ------------
Total current assets 20,729,797 22,364,126
OTHER ASSETS 4,403,273 4,484,236
------------ ------------
$ 25,133,070 $ 26,848,362
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES $ 6,678,543 $ 5,755,890
LONG-TERM LIABILITIES - 649,880
SHAREHOLDERS' EQUITY
Common stock 74,232,813 73,640,801
Accumulated deficit (55,778,286) (53,198,209)
------------ ------------
Total shareholders' equity 18,454,527 20,442,592
------------ ------------
$ 25,133,070 $ 26,848,362
============ ============