Bone Care International Announces Third Quarter 2003 Results.Business Editors 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)--April 24, 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 results for the third quarter ended March 31, 2003. Revenues for the three months ended March 31, 2003 were $3,078,000 compared to $3,775,000 for the quarter ended March 31, 2002. Revenues for the nine months ended March 31, 2003 were $12,238,000 compared to $10,259,000 for the nine months ended March 31, 2002. As previously announced, third quarter sales 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 resulting from the temporary interruption of supply of Hectorol(R) Injection (doxercalciferol) that began in the prior quarter. Commercial shipments of Hectorol Injection were resumed in mid-March. Bone Care reported a net loss of $4,625,000 or $0.33 per share, for the three months ended March 31, 2003, compared to net loss of $1,781,000, or $0.13 per share, for the same period last year. The net loss for the nine months ended March 31, 2003 was $10,384,000, or $0.73 per share, compared to a net loss of $5,171,000, or $0.37 per share, for the nine months ended March 31, 2002. Cost of sales includes validation expenses of $416,000 and $979,000, respectively, for the three and nine months ended March 31, 2003, primarily related to the technology transfer and subsequent validation of the manufacturing process at DRAXIS Pharma. The Company anticipates total revenues will be approximately $7,000,000 in the fourth quarter year ended June 30, 2003, based on the current production schedule for Hectorol Injection by DRAXIS Pharma and historic sales patterns. This level of production would meet the expected demand of current customers and patients and allow the Company to begin to supply new patients and customers by the end of the June quarter. During the March quarter, 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. ) accepted a CBE-30 (changes being effected in 30 days) supplemental application A Supplemental Application Is A Type Of Application Used By universities and Colleges From the State University Of New York(SUNY). The Supplemental Application is A common 2nd part of The 1st State-wide Application. for DRAXIS Pharma, wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of DRAXIS, Inc. (NASDAQ:DRAX; TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :DAX), as an additional manufacturing site for Bone Care's Hectorol Injection. This acceptance allowed Bone Care to resume production of Hectorol Injection and commence commercial shipments of this product on March 14, 2003. DRAXIS Pharma operates out of a 247,000 square-foot c-GMP (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. ) facility in Montreal, Canada. 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 made significant progress during the quarter and are pleased to report that the Bone Care and DRAXIS Pharma technical teams met 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. necessary to allow Bone Care to begin shipping Hectorol Injection to our customers. We look forward to increasing our production and sales through the remainder of 2003 as we execute our targeted customer business plans." Bone Care is also working with the FDA on 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 upon typical FDA review time, commercial launch of this product could occur by the end of calendar 2003. Mr. Berns continued, "We believe the CKD market presents an attractive opportunity with a current estimated 400,000 patient population in Stage 4 pre-dialysis 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 . We are working with the FDA to gain approval of Hectorol Capsules for treatment of CKD patients prior to dialysis and a possible commercial launch by the end of 2003. Additionally, we continue to move forward with our plans to engage a partner for co-promotion of this product to better develop this market opportunity." Management will host a conference call on Friday, April 25, 2003, at 9:00 a.m. CDT CDT abbr. Central Daylight Time CDT Central Daylight Time CDT n abbr (US) (= Central Daylight Time) → hora de verano del centro; (BRIT . 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 (877) 234-1973; the dial-in number for international participants is (973) 582-2732. The call is available for playback until midnight on April 28, 2003 at (877) 519-4471 within North America and at (973) 341-3080 for international callers. The playback pass code is 3865714. The call can also be accessed via webcast and will be archived for playback at www.bonecare.com/conferencecall. Bone Care (www.bonecare.com) 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, 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, breast and colon. Hectorol Injection is approved for the treatment of secondary hyperparathyroidism in patients with end stage renal disease. 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, 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 Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities in connection therewith there·with adv. 1. With that, this, or it. 2. In addition to that. 3. Archaic Immediately thereafter. Adv. 1. , 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
(Unaudited)
Three Months Ended, Nine Months Ended,
------------------------ -------------------------
March 31, March 31, March 31, March 31,
2003 2002 2003 2002
------------------------ -------------------------
Revenues $3,078,022 $3,774,692 $12,238,435 $10,258,829
Operating Expenses:
Cost of sales 1,527,174 889,957 4,496,618 2,276,675
Research and
development 1,577,120 1,687,705 4,553,280 4,279,453
Sales and
Marketing 3,223,289 2,450,436 10,023,999 7,247,053
General and
administrative 1,488,187 812,975 4,028,209 2,621,203
------------------------ -------------------------
7,815,770 5,841,073 23,102,106 16,424,384
------------------------ -------------------------
Loss from operations (4,737,748) (2,066,381) (10,863,671) (6,165,555)
Interest income 112,989 285,753 480,079 994,825
------------------------ -------------------------
Net loss $(4,624,759)$(1,780,628) $(10,383,592)$(5,170,730)
======================== =========================
Net loss per common
share basic and
diluted $(0.33) $(0.13) $(0.73) $(0.37)
======================== =========================
Weighted average
number of common
shares 14,168,652 14,124,449 14,160,893 14,061,066
BONE CARE INTERNATIONAL, INC.
Unaudited Condensed Balance Sheets
March 31, June 30,
2003 2002
------------------------
ASSETS
Current Assets:
Cash and cash equivalents $1,764,362 $2,023,969
Marketable securities 15,178,948 18,436,896
Accounts receivable, net of allowance
for doubtful accounts of $203,009 and
$152,960 at March 31, 2003 and June 30,
2002, respectively 2,468,275 4,285,569
Inventories 2,039,348 2,099,469
Other current assets 980,170 775,596
------------------------
Total current assets 22,431,103 27,621,499
------------------------
Long-term securities 914,657 3,719,796
Other long-term assets 110,300 -
Property, plant, and equipment - at cost
Leasehold improvements 588,632 588,632
Furniture and fixtures 543,782 452,345
Machinery and other equipment 2,886,485 2,317,405
------------------------
4,018,899 3,358,382
Less accumulated depreciation and
amortization 2,119,276 1,573,497
------------------------
1,899,623 1,784,885
Patent fees, net of accumulated
amortization of $1,099,907 at
March 31, 2003 and $998,027 at
June 30, 2002 1,268,387 1,198,249
Goodwill 359,165 359,165
------------------------
$26,983,235 $34,683,594
========================
BONE CARE INTERNATIONAL, INC.
Unaudited Condensed Balance Sheets
Liabilities and Shareholders' Equity
March 31, 2003 June 30, 2002
----------------------------
Current Liabilities:
Accounts payable $2,465,856 $1,769,665
Accrued Liabilities
Accrued clinical study and
research costs 516,777 152,352
Compensation payable 1,257,613 509,677
Accrued health and dental costs 56,281 -
Other current liabilities 347 1,924
Allowance for sales returns 299,520 226,100
----------------------------
Total current liabilities 4,596,394 2,659,718
Long term liabilities 676,868 -
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 14,215,372 at March 31,
2003 and 14,156,722 at June 30, 2002 11,393,883 11,393,883
Additional paid-in capital 62,219,918 62,096,272
Accumulated deficit (51,903,828) (41,520,236)
Accumulated other comprehensive income
(loss) - 53,957
----------------------------
Total shareholder's equity 21,079,973 32,023,876
----------------------------
$ 26,983,235 $ 34,683,594
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