Bone Care International Announces Fourth Quarter 2000 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)--August 9, 2000 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 a net loss of $9,805,245, or $0.89 per share for the fiscal year ended June 30, 2000, compared to a net loss of $5,776,615, or $0.57 per share for the fiscal year ended June 30, 1999. Net losses totaled $2,956,244, or $0.26 per share in the quarter ended June 30, 2000, compared with a net loss of $1,212,546, or $0.12 per share, for the quarter ended June 30, 1999. Revenues from Hectorol(R) Capsules were $119,163 for the quarter ended June 30, 2000, and $234,741 for the fiscal year ended June 30, 2000. Losses increased primarily as a result of increased sales and marketing expenses related to the promotion of Hectorol Capsules and the forthcoming launch of Hectorol Injection later this month by the Company's expanding sales force. Gross margins in the quarter ended June 30, 2000, were impacted by a $400,000 write-down of Hectorol Capsule capsule In botany, a dry fruit that opens when ripe. It splits from top to bottom into separate segments known as valves, as in the iris, or forms pores at the top (e.g., poppy), or splits around the circumference, with the top falling off (e.g., pigweed and plantain). inventory manufactured well in advance of 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. approval. The FDA requires three full-size production runs prior to granting approval to sell a new pharmaceutical product. During the fourth quarter, management determined the quantities produced exceeded the amounts expected to be sold prior to expiration. Hectorol Injection is a new intravenous 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 97% of the over $400 million market for D-hormones in dialysis. In contrast, Hectorol Capsules target only 3 % of this market. 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. ). Hectorol Injection was even significantly safer than Hectorol Capsules in clinical trials involving hemodialysis hemodialysis /he·mo·di·al·y·sis/ (-di-al´i-sis) removal of certain elements from the blood by virtue of the difference in rates of their diffusion through a semipermeable membrane while being circulated outside the body; the process patients. Bone Care recently 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 later this year 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, 2000. 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 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 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.
Statements of Operations
Three Months Ended
------------------
June 30, June 30,
2000 1999
--------------------------------
Revenues
Product sales $ 119,163 $ --
Other revenues 496 --
------------ ------------
119,659 --
Cost of sales 72,015 --
Inventory write-down 400,000 --
------------ ------------
472,015 --
Gross margin (352,356) --
Operating expenses
Research and development 1,053,682 717,607
Sales and marketing 1,195,178 292,444
General and administrative 518,865 298,774
------------ ------------
2,767,725 1,308,825
------------ ------------
Loss from operations (3,120,081) (1,308,825)
Interest income 163,837 96,279
------------ ------------
Pre-tax loss (2,956,244) (1,212,546)
Tax expense -- --
------------ ------------
Net loss $(2,956,244) $(1,212,546)
============ ============
Net loss per common share - basic $ (0.26) $ (0.12)
============ ============
Weighted average number of
common shares 11,456,334 10,156,714
============ ============
BONE CARE INTERNATIONAL, INC.
Statements of Operations
Year Ended
----------------------------------
June 30, June 30,
2000 1999
----------------------------------
Revenues
Product sales $ 234,741 $ --
Other revenues 149,996 --
-------------- --------------
384,737 --
Cost of sales 102,834 --
Inventory write-down 400,000 --
------------- --------------
502,834 --
Gross margin (118,097) --
Operating expenses
Research and development 4,048,608 3,455,401
Sales and marketing 4,481,598 1,715,837
General and administrative 1,800,016 1,138,948
------------- --------------
10,330,222 6,310,186
------------- --------------
Loss from operations (10,448,319) (6,310,186)
Interest income 655,574 533,571
------------- --------------
Pre-tax loss (9,792,745) (5,776,615)
Tax expense 12,500 --
------------- --------------
Net loss $ (9,805,245) $ (5,776,615)
============= ==============
Basic and Diluted net loss
per common share - basic $ (0.89) $ (0.57)
============= ==============
Weighted average number of
common shares 11,070,667 10,055,327
============= ==============
BONE CARE INTERNATIONAL, INC.
Balance Sheets
June 30, June 30,
2000 1999
--------------- ---------------
Assets
Current assets:
Cash and cash equivalents $ 4,735,780 $ 7,313,551
Marketable securities 4,972,175 --
Trade receivables 29,481 --
Inventory 639,271 1,119,262
Other current assets 229,438 110,017
--------------- ---------------
Total current assets 10,606,145 8,542,830
Property, plant
and equipment - net 446,188 309,592
Intangible assets - net 1,407,593 1,400,706
Other non-current assets -- 50,133
---------------- ----------------
Total Assets $ 12,459,926 $ 10,303,261
================ ================
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 400,949 $ 202,686
Accrued clinical study and
research costs 213,718 171,988
Other current liabilities 762,072 211,788
---------------- ----------------
Total current liabilities 1,376,739 586,462
Shareholders' equity 11,083,187 9,716,799
---------------- ----------------
Total Liabilities and
Shareholders' Equity $ 12,459,926 $ 10,303,261
================ ================
|
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion