Bone Care International Announces Fourth Quarter 2002 Results.Business Editors/Health & Medical Writers MIDDLETON, Wis adv. 1. Certainly; really; indeed. v. t. 1. To think; to suppose; to imagine; - used chiefly in the first person sing. present tense, I wis. See the Note under Ywis. .--(BUSINESS WIRE)--Aug. 5, 2002 Bone Care International, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : BCII BCII Battle Command and Intelligence Integration ) today announced that revenues for the quarter ended June 30, 2002 increased to $4,732,000 from $2,059,000 in the quarter ended June 30, 2001. Revenues for the year ended June 30, 2002 increased to $14,991,000 from $5,997,000 in the year ended June 30, 2001. The increased revenue in the fourth quarter of fiscal 2002 compared to the corresponding quarter in the prior year was primarily the result of increased sales of Hectorol Hectorol™ Endocrinology An agent for managing 2º hyperparathyroidism linked to ESRD, which may used in predialysis Pts (R) Injection, which have been positively impacted by the implementation of a national Medicare Medicare, national health insurance program in the United States for persons aged 65 and over and the disabled. It was established in 1965 with passage of the Social Security Amendments and is now run by the Centers for Medicare and Medicaid Services. billing code, which became effective as of January 1, 2002. Bone Care reported a net loss of $1,733,000, or $0.12 per share, for the quarter ended June 30, 2002, compared to a net loss of $2,374,000, or $0.17 per share, for the quarter ended June 30, 2001. Net losses totaled $6,904,000, or $0.49 per share, for the year ended June 30, 2002, compared to a net loss of $9,014,000, or $0.70 per share, for the year ended June 30, 2001. As we have previously disclosed, the manufacturer of Hectorol Injection halted production of our product after the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. identified current Good Manufacturing Practices Good Manufacturing Practice or GMP (also referred to as 'cGMP' or 'current Good Manufacturing Practice') is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. deficiencies. This manufacturer has been working with us and the FDA to remediate re·me·di·a·tion n. The act or process of correcting a fault or deficiency: remediation of a learning disability. re·me the violations noted by the FDA by making additional investments in their manufacturing facility, acquiring new equipment and improving their manufacturing processes and controls. We last reported that our manufacturer expected to produce commercial product in July. That date has been postponed, and our manufacturer currently estimates production of validation See validate. validation - The stage in the software life-cycle at the end of the development process where software is evaluated to ensure that it complies with the requirements. lots in September that ultimately could be used as commercial product. If our manufacturer completes the validation lots by the end of October and passes the FDA site inspection and the FDA accelerates their review of our submission, we do not anticipate a reduction in revenue as a result of a reduced supply of product. If our manufacturer does not meet this timetable, we could experience a reduction in revenue. We are actively managing the inventory levels of the supplier channels so that the end-users of our product, clinics and patients, do not experience any shortage of product. We expect to provide further updates within 60 days and as events warrant. In addition, as we discussed on the last conference call, we have been working on contingency plans A plan involving suitable backups, immediate actions and longer term measures for responding to computer emergencies such as attacks or accidental disasters. Contingency plans are part of business resumption planning. , including the alternative source of supply. We anticipate that an alternative source would be available in the first quarter of calendar 2003. Paul Berns, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Bone Care, commented as follows: "I want to assure customers and shareholders that we are working productively with the FDA and with our contract manufacturer and taking all steps possible to avoid an inventory shortfall Shortfall The amount by which the capital required to fulfill a financial obligation exceeds available capital. Notes: Shortfall risk is often combated with an efficient hedging strategy created by a fund, group, institution, or individual. . While we are dealing forthrightly forth·right adj. 1. Direct and without evasion; straightforward: a forthright appraisal; forthright criticism. 2. Archaic Proceeding straight ahead. adv. 1. with the supply issues, we have taken significant steps toward improving the overall leadership team at Bone Care. Recent management team additions include Andrew Morgan Morgan, American family of financiers and philanthropists. Junius Spencer Morgan, 1813–90, b. West Springfield, Mass., prospered at investment banking. , Vice President of Regulatory, and Jim Caruso, Vice President of Sales. I am confident our current management team has the experience and leadership skills to resolve these issues and provide real value to our shareholders and the patients we serve." Bone Care is a pharmaceutical company engaged in discovering, developing and commercializing improved vitamin D-hormone therapies to treat secondary hyperparathyroidism secondary hyperparathyroidism Endocrinology ↑ Parathyroid activity with overproduction of PTH due to parathyroid hyperplasia in response to an extraparathyroid defect that results in ↓ Ca2+ Etiology Rickets, vitamin D deficiency, chronic renal failure in patients with kidney, or renal disease Renal disease Kidney disease. Mentioned in: Glycogen Storage Diseases hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg , and osteoporosis osteoporosis (ŏs'tēō'pərō`sĭs), disorder in which the normal replenishment of old bone tissue is severely disrupted, resulting in weakened bones and increased risk of fracture; osteopenia , and other diseases including psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the and cancers of the prostate prostate /pros·tate/ (pros´tat) a gland surrounding the bladder neck and urethra in the male; it contributes a secretion to the semen.prostat´ic pros·tate n. The prostate gland. adj. , breast and colon colon, in anatomy colon, in anatomy: see intestine. colon, in punctuation colon, in writing: see punctuation. colon Segment that makes up most of the large intestine. . This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. . Statements relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc future net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight , 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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, technical risks associated with the development of new products, regulatory policies in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and other countries, reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. 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.
Statement of Operations
(Audited)
Three Months Ended
---------------------------
June 30, June 30,
2002 2001
------ ------
Revenues $ 4,731,920 $ 2,058,732
Operating Expenses:
Cost of sales 1,280,013 545,567
Research and development 1,459,699 1,265,411
Sales and marketing 3,028,860 2,118,526
General and administrative 958,860 952,713
------------ ------------
6,727,432 4,882,217
------------ ------------
Loss from operations (1,995,512) (2,823,485)
Interest income 262,347 449,031
------------ ------------
Loss before income tax (1,733,165) (2,374,454)
Income tax expense - -
------------ ------------
Net loss $(1,733,165) $(2,374,454)
============ ============
Net loss per common share -
basic and diluted $(0.12) $(0.17)
======= =======
Weighted average common stock
shares outstanding 14,154,000 13,941,000
============ ============
BONE CARE INTERNATIONAL, INC.
Statement of Operations
(Audited)
Year Ended
---------------------------
June 30, June 30,
2002 2001
------ ------
Revenues $14,990,749 $5,997,282
Operating Expenses:
Cost of sales 3,556,687 1,904,839
Research and development 5,739,152 4,556,061
Sales and marketing 10,275,913 7,197,839
General and administrative 3,580,063 2,661,735
------------ ------------
23,151,815 16,320,474
------------ ------------
Loss from operations (8,161,066) (10,323,192)
Interest income 1,257,171 1,308,941
------------ ------------
Loss before income tax (6,903,895) (9,014,251)
Income tax expense - -
------------ ------------
Net loss $(6,903,895) $(9,014,251)
============ ============
Net loss per common share -
basic and diluted $(0.49) $(0.70)
======= =======
Weighted average common stock
shares outstanding 14,084,000 12,884,000
============ ============
BONE CARE INTERNATIONAL, INC.
Balance Sheets
June 30, 2002 June 30, 2001
(Audited) (Audited)
------------- -------------
Assets
Current assets:
Cash and cash equivalents $ 2,023,969 $ 1,842,838
Marketable securities 18,436,896 15,079,575
Accounts receivable, net of
allowance for doubtful accounts of
$152,960 at June 30, 2002 and
$100,000 at June 30, 2001 4,285,569 3,347,300
Inventories 2,099,469 1,810,574
Other current assets 775,596 1,085,103
------------ ------------
Total current assets 27,621,499 23,165,390
Long-term securities 3,719,796 14,424,490
Property, plant, and equipment - net 1,784,885 1,503,005
Intangible assets, net 1,557,414 1,384,485
------------ ------------
Total Assets $34,683,594 $40,477,370
============ ============
Liabilities And Shareholders' Equity
Current liabilities:
Accounts payable $ 1,769,665 $ 1,612,543
Accrued liabilities
Compensation payable 509,677 208,930
Accrued clinical study and
research costs 152,352 147,635
Due to customers - 135,102
Other 1,924 70,055
Allowance for sales returns 226,100 205,000
------------ ------------
Total current liabilities 2,659,718 2,379,265
Shareholders' equity 32,023,876 38,098,105
------------ ------------
Total liabilities and
shareholders' equity $34,683,594 $40,477,370
============ ============
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