Bone Care International Announces Second Quarter 2003 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)--Jan. 27, 2003 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 revenues for the second quarter ended December 31, 2002 decreased to $3,743,000 from $3,832,000 in the quarter ended December 31, 2001. Revenues for the first six months ended December 31, 2002 increased to $9,160,000 from $6,484,000 in the six months ended December 31, 2001. Bone Care reported a net loss of $4,128,000, or $0.29 per share for the second quarter ended December 31, 2002 compared to a net loss of $1,254,000, or $0.09 per share for the quarter ended December 31, 2001. The net loss was $5,759,000, or $0.41 per share for the first six months ended December 31, 2002, compared to a net loss of $3,390,000, or $0.24 per share for the six months ended December 31, 2001. As previously disclosed, second quarter sales of Hectorol(R) Injection were constrained con·strain tr.v. con·strained, con·strain·ing, con·strains 1. To compel by physical, moral, or circumstantial force; oblige: felt constrained to object. See Synonyms at force. 2. by an inventory shortage. The U.S. Food and Drug Administration (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. ) is currently conducting a site inspection at Akorn Inc., the supplier of Hectorol Injection. Bone Care and Akorn believe that Akorn has completed the manufacturing process 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. batches necessary to commence commercial production and distribution. If the FDA site inspection determines that Akorn is in acceptable compliance with 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. , Bone Care intends to submit a CBE-30 (changes being effected in 30 days) with respect to the manufacturing and process improvements at Akorn. DRAXIS Pharma has nearly completed manufacturing of the process validation batches necessary to qualify as an additional supplier of Hectorol Injection. Bone Care anticipates filing a CBE-30 with respect to DRAXIS upon completion of the regulatory requirements Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. . As previously disclosed, Bone Care cannot resume shipments of Hectorol Injection until one of these suppliers gains FDA clearance. Cost of sales includes approximately $455,000 for the quarter and $551,000 for the six months ended December 31, 2002, associated with the remediation of manufacturing issues at Akorn and validation costs related to DRAXIS Pharma. Bone Care announced that it has submitted its response to an "approvable letter" received from the FDA in connection with its supplemental New Drug Application (sNDA) for Hectorol Capsules. The sNDA proposes a new indication, treatment of 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 chronic kidney disease Chronic kidney disease (CKD), also know as chronic renal disease, is a progressive loss of renal function over a period of months or years through five stages. Each stage is a progression through an abnormally low and progressively worse glomerular filtration rate, which is (CKD See count-key-data. ) patients prior to 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. . Based on typical FDA response times, the Company anticipates that if the FDA approves the sNDA, commercial launch could occur in the latter half of 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. , commented, "We have provided a robust response to the FDA approvable letter and will work diligently dil·i·gent adj. Marked by persevering, painstaking effort. See Synonyms at busy. [Middle English, from Old French, from Latin d to gain approval of the sNDA. We await AWAIT, crim. law. Seems to signify what is now understood by lying in wait, or way-laying. the completion of the ongoing activities at Akorn and DRAXIS Pharma, and we anticipate filing for FDA clearance to sell product manufactured by one or both of the manufacturers as soon as possible after those activities are completed. We currently anticipate that we will have commercial supply of Hectorol Injection from one or both of our contract manufacturers during the current quarter ending March 31, 2003, although we cannot give assurance, given the nature of the regulatory process." Management will host a conference call on Tuesday, January 28, 2003, at 10:00 a.m. Central time. The toll-free number within North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. is (888) 881-4892; the dial-in number for international participants is (416) 640-4127. The call is available for playback until midnight on January 30, 2003 at (877) 289-8525 within North America and at (416) 640-1917 for international callers. The playback pass code is 232895. The call can also be accessed via web cast at www.bonecare.com/conferencecall. The presentation will be archived for playback at Bone Care's Web site, www.bonecare.com. Bone Care is a pharmaceutical company engaged in discovering, developing and commercializing improved vitamin D-hormone therapies to treat secondary hyperparathyroidism 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. 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
Three Months Ended, Six Months Ended,
-------------------------- --------------------------
December 31, December 31, December 31, December 31,
2002 2001 2002 2001
-------------------------- --------------------------
Revenues $3,743,013 $3,831,997 $9,160,413 $6,484,137
Operating
Expenses:
Cost of sales 1,459,838 793,812 2,969,444 1,386,718
Research and
development 1,527,725 1,200,031 2,976,160 2,591,748
Sales &
Marketing 3,775,761 2,546,782 6,800,711 4,796,617
Administrative 1,259,696 893,294 2,540,022 1,808,228
-------------------------- --------------------------
8,023,020 5,433,919 15,286,337 10,583,311
Loss from
Operations (4,280,007) (1,601,922) (6,125,924) (4,099,174)
Interest income 152,312 348,019 367,091 709,072
-------------------------- --------------------------
Loss before
income tax (4,127,695) (1,253,903) (5,758,833) (3,390,102)
Income tax
expense - - - -
-------------------------- --------------------------
Net loss $ (4,127,695) $ (1,253,903) $ (5,758,833) $ (3,390,102)
========================== ==========================
Weighted
average
common shares
outstanding 14,157,425 14,072,551 14,157,099 14,030,063
Net loss per
common share $ (0.29) $ (0.09) $ (0.41) $ (0.24)
========================== ==========================
BONE CARE INTERNATIONAL, INC.
BALANCE SHEETS
December 31, 2002 June 30, 2002
Unaudited Audited
------------------------------------
ASSETS
Current Assets:
Cash and cash equivalents 2,252,745 2,023,969
Marketable securities 16,685,097 18,436,896
Accounts receivable, net of
allowance for doubtful
accounts of $152,819 at
December 31, 2002 and
$152,960 at June 30, 2002. 3,233,158 4,285,569
Inventories 1,756,831 2,099,469
Other current assets 1,261,260 775,596
------------------------------------
Total current assets 25,189,091 27,621,499
Long term securities 1,939,232 3,719,796
Other long-term assets 110,300 -
Property, plant, and
equipment - at cost
Leasehold improvements 588,632 588,632
Furniture and fixtures 479,600 452,345
Machinery and other equipment 2,703,822 2,317,405
------------------------------------
3,772,054 3,358,382
Less accumulated depreciation
and amortization 1,909,257 1,573,497
------------------------------------
1,862,797 1,784,885
Patent fees, net of accumulated
amortization of $1,070,827 at
December 31, 2002 and $988,026
at June 30, 2002 1,246,339 1,198,249
Goodwill, net of accumulated
amortization of $1,000,752 as
of December 31, 2002 and
June 30, 2002 359,165 359,165
------------------------------------
30,706,924 34,683,594
====================================
LIABILITIES AND SHAREHOLDER'S
EQUITY
Current Liabilities:
Accounts payable 2,218,715 1,769,665
Accrued Liabilities
Accrued clinical study and
research costs 363,273 152,352
Compensation payable 1,155,930 509,677
Other 613 1,924
Allowance for sales returns 299,520 226,100
------------------------------------
Total current liabilities 4,038,051 2,659,718
Long term liabilities 437,691 -
Shareholder's 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
14,157,722 at December 31, 2002
and 14,156,722 at June 30, 2002
respectively 11,393,883 11,393,883
Additional paid-in capital 62,098,382 62,096,272
Accumulated deficit (47,279,069) (41,520,236)
Accumulated other
comprehensive income (loss) 17,986 53,957
------------------------------------
Total shareholder's equity 26,231,182 32,023,876
------------------------------------
30,706,924 34,683,594
====================================
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