Bone Care International Announces Fourth Quarter 2001 Results.Business Editors Madison, 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. 6, 2001 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 total revenues for the quarter ended June 30, 2001 were $2,059,000 compared to $120,000 for the quarter ended June 30, 2000. Total revenues for the year ended June 30, 2001 were $5,997,000 compared to $385,000 for the year ended June 30, 2000. These increases reflect the introduction of Hectorol(R) Injection in September, 2000. Hectorol Injection is an intravenous intravenous /in·tra·ve·nous/ (-ve´nus) within a vein or veins.intrave´nously in·tra·ve·nous adj. Abbr. IV Within or administered into a vein. D-hormone treatment for reducing elevated parathyroid hormone parathyroid hormone or parathormone, a hormone secreted by the parathyroid glands that regulates the metabolism of calcium and phosphate in the body. levels in patients undergoing chronic renal dialysis dialysis (dīăl`ĭsĭs), in chemistry, transfer of solute (dissolved solids) across a semipermeable membrane. Strictly speaking, dialysis refers only to the transfer of the solute; transfer of the solvent is called osmosis. . This product targets the approximate $600 million market 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. for D-hormones in dialysis. Hectorol Injection differs from competitive products because it provides a prolonged pro·long tr.v. pro·longed, pro·long·ing, pro·longs 1. To lengthen in duration; protract. 2. To lengthen in extent. normalization In relational database management, a process that breaks down data into record groups for efficient processing. There are six stages. By the third stage (third normal form), data are identified only by the key field in their record. of active D-hormones into the blood with minimal side effects Side effects Effects of a proposed project on other parts of the firm. (elevation of blood calcium blood calcium, n the level of calcium in the blood plasma, generally regulated by parathyroid gland activity in conjunction with the degree of calcium ingestion, absorption, use, and excretion. Normal value is 8.5 to 11.5 mg/100 ml of blood serum. and phosphorus phosphorus (fŏs`fərəs) [Gr.,=light-bearing], nonmetallic chemical element; symbol P; at. no. 15; at. wt. 30.97376; m.p. 44.1°C;; b.p. about 280°C;; sp. gr. 1.82 at 20°C;; valence −3, +3, or +5. ). Bone Care reported an overall net loss of $9,014,000, or $0.70 per share for the fiscal year ended June 30, 2001, compared to a net loss of $9,805,000, or $0.89 per share for the fiscal year ended June 30, 2000. The net loss was $2,374,000, or $0.17 per share in the quarter ended June 30, 2001, compared with a net loss of $2,956,000, or $0.26 per share, for the quarter ended June 30, 2000. Richard B. Mazess, Ph.D., acting president, indicated that the US market would not be fully accessible until nationwide Medicare reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. was readily available, an event expected to occur in January 2002. However, he stated that "Since reimbursement has recently become available in some major regions of the US market, the company is accelerating its marketing efforts." Bone Care has completed two double-blind Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. of Hectorol Capsules in pre-dialysis patients with 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 . The pre-dialysis population is conservatively estimated at over 600,000 patients. The Company plans to file a supplemental New Drug Application requesting marketing approval for Hectorol Capsules for use in this population. The Annual Meeting of Bone Care Shareholders will be held in Madison, Wisconsin Madison is the capital of the U.S. state of Wisconsin and the county seat of Dane County. It is also home to the University of Wisconsin–Madison. The 2006 population estimate of Madison was 223,389, making it the second largest city in Wisconsin, after Milwaukee, and , on November 15, 2001. Bone Care is an emerging pharmaceutical company with a platform of improved vitamin D-hormone therapies for the treatment of diverse diseases involving the vitamin D hormone Vitamin D hormone Vitamin D is a vitamin that also acts as a hormone. Vitamin D hormone acts with parathyroid hormone to regulate calcium levels in the blood and to supply appropriate amounts of calcium to all cells. Mentioned in: Hypercalcemia receptor. Treatment of secondary hyperparathyroidism associated with both renal failure renal failure n. Acute or chronic malfunction of the kidneys resulting from any of a number of causes, including infection, trauma, toxins, hemodynamic abnormalities, and autoimmune disease, and often resulting in systemic symptoms, especially edema, and senile osteoporosis Senile Osteoporosis Formely known as osteoporosis type II, senile osteoporosis has been recently recognized as a geriatric syndrome with a particular pathohysiology. A clinician scientist at the University of Sydney, Dr. are the first applications of this platform. Additional applications include the treatment of hyperproliferative disorders, such as 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 breast, 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. and colon. 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 and other countries, 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.
Statements of Operations
Three Months Ended
June 30, June 30,
2001 2000
-------------------------------
Revenues
Product sales $ 2,058,732 $ 119,163
Other revenues -- 496
-------------- --------------
2,058,732 119,659
Cost of sales 545,567 72,015
Inventory write-down -- 400,000
-------------- ------------
545,567 472,015
Gross margin 1,513,165 (352,356)
Operating expenses
Research and development 1,265,411 1,053,682
Sales and marketing 2,118,526 1,195,178
General and administrative 952,713 518,865
-------------- --------------
4,336,650 2,767,725
-------------- --------------
Loss from operations (2,823,485) (3,120,081)
Interest income 449,031 163,837
-------------- --------------
Loss before income tax (2,374,454) (2,956,244)
Income tax expense -- --
-------------- --------------
Net loss $(2,374,454) $(2,956,244)
=============== ============
Weighted average number of
common shares 13,941,157 11,456,334
============= =============
Basic and Diluted net loss
per common share - basic $ (0.17) $ (0.26)
============== =================
BONE CARE INTERNATIONAL, INC.
Statements of Operations
Year Ended
June 30, June 30,
2001 2000
-------------------------
Revenues
Product sales $ 5,997,282 234,741
Other revenues -- 149,996
----------- ------------
5,997,282 384,737
Cost of Sales 1,644,839 102,834
Inventory write-down 260,000 400,000
----------- ---------
1,904,839 502,834
Gross margin 4,092,443 (118,097)
Operating expenses
Research and development 4,556,061 4,048,608
Sales and marketing 7,197,839 4,481,598
General and administrative 2,661,735 1,800,016
----------- ------------
14,415,635 10,330,222
Loss from operations (10,323,192) (10,448,319)
Interest income 1,308,941 655,574
----------- ------------
Loss before income tax (9,014,251) (9,792,745)
Income tax expense -- 12,500
----------- -----------
Net loss $(9,014,251) $(9,805,245)
=========== ===========
Weighted average number of
common shares 12,883,632 11,070,667
=========== =============
Net loss per common share - basic $ (0.70) $ (0.89)
=========== =============
BONE CARE INTERNATIONAL, INC.
Balance Sheets
June 30, June 30,
2001 2000
------------------------------
Assets
Current assets:
Cash and cash equivalents $ 1,842,838 $ 4,735,780
Marketable securities 12,776,382 4,972,175
Trade receivables 3,347,300 29,481
Inventory 1,810,574 639,271
Other current assets 1,085,103 229,438
------------ --------------
Total current assets 20,862,197 10,606,145
Long term securities 16,727,683 -
Property, plant and equipment
- at cost 1,503,005 446,188
Intangible assets - net 1,384,485 1,407,593
------------- -------------
Total Assets $ 40,477,370 $12,459,926
============ ===========
Liabilities and Shareholders'
Equity
Current liabilities:
Accounts payable $ 186,266 $ 400,949
Accrued clinical study
and research costs 147,635 213,718
Other current liabilities 2,045,364 762,072
------------ ---------------
Total current liabilities 2,379,265 1,376,739
Shareholders' equity 38,098,105 11,083,187
------------- ------------
Total Liabilities and
Shareholders' Equity $ 40,477,370 $12,459,926
============ ===========
--30--ajb/cgo* CONTACT: Bone Care International, Inc. Robert Beckman, 608/662-7800 Fax: 608/662-0032 KEYWORD: WISCONSIN INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL EARNINGS CONFERENCE CALLS SOURCE: Bone Care International, Inc. |
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