Bone Care International Reports Record Fourth Quarter Product Sales of $7.3 Million; Fiscal 2004 Product Sales Guidance of $35-40 Million.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)--July 28, 2003 Company Targets Fourth Quarter Fiscal 2004 Transition to Profitability; Oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. IND Filing Planned for a Lead Pipeline Product in September Bone Care International, Inc. (Nasdaq:BCII BCII Battle Command and Intelligence Integration ) a specialty pharmaceutical company engaged in the discovery, development and commercialization of improved vitamin-D hormone therapies Hormone therapy Treating cancers by changing the hormone balance of the body, instead of by using cell-killing drugs. Mentioned in: Breast Cancer, Thyroid Cancer hormone therapy , announced today that revenues for the three months ended June 30, 2003 increased 54 percent to $7.3 million, compared to $4.7 million for the same quarter in 2002. Revenues for the fiscal year ended June 30, 2003 increased 30 percent to $19.5 million, compared to $15.0 million in the fiscal year ended June 30, 2002. Bone Care reported a net loss of $1.3 million, or $0.09 per share, for the three months ended June 30, 2003, compared to a net loss of $1.7 million, or $0.12 per share, for the same quarter in 2002. The net loss for the fiscal year ended June 30, 2003 was $11.7 million, or $0.82 per share, compared to a net loss of $6.9 million, or $0.49 per share, for the fiscal year ended June 30, 2002. The Company reiterated prior guidance that it currently expects revenues from product sales to increase to approximately $35 to $40 million in the fiscal year ended June 30, 2004. Bone Care currently targets a transition to profitability by the fourth quarter of fiscal 2004. "We are particularly encouraged by the revenue growth in the June quarter as it reflects our first full quarter of sales for Hectorol(R) (doxercalciferol) Injection since the re-launch," said Paul L. Berns, President and Chief Executive Officer of Bone Care. "The vast majority of our established customers demonstrated their support for Hectorol Injection by placing orders in the June quarter. Fourth quarter sales were primarily driven by patient and customer demand, with many wholesalers reporting a lower than normal supply of inventory at the end of June. We are meeting existing and new patient customer demand while building the wholesaler inventory levels." Bone Care is also working with 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. in regards to its supplemental New Drug Application (sNDA) for Hectorol Capsules. The sNDA proposes a new indication, the 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. . "The new indication for the treatment of pre-dialysis CKD presents a significant opportunity to provide care for the estimated 7.6 million Stage 3 and 400,000 Stage 4 patient populations," Mr. Berns continued. "We currently anticipate that FDA approval could occur by the end of calendar 2003 and commercial launch shortly thereafter. In expectation of approval, we are actively exploring potential partnerships for the co-promotion of this product." Bone Care also announced that it plans to submit an Investigational New Drug application (IND) for a lead pipeline product, LR-103. The IND is scheduled to be submitted in the third quarter of this calendar year. The initial Phase I study in approximately 30 oncology patients will be conducted through the University of Wisconsin in Madison, beginning in the fourth quarter of 2003. This dose-ranging study A dose-ranging study is a clinical trial where different doses of an agent (e.g. a drug) are tested against each other to establish which dose works best and/or is least harmful. Dose-ranging is usually a phase I or early phase II clinical trial. is designed to assess the tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol and pharmacokinetic profile of oral LR-103 following single- and multiple-dose administration. Management will host a conference call on July 29, 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 (888) 694-4728; the dial-in number for international participants is (973) 582- 2720. The call is available for playback Playback could mean:
Bone Care (www.bonecare.com) is a specialty 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 other diseases including 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 , 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. . Hectorol Injection and Hectorol Capsules are approved for the treatment of secondary hyperparathyroidism in patients with end stage renal disease (Stage 5 chronic kidney 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, the ability of the Company and its supplier of Hectorol Injection to meet the Company's anticipated production schedule, 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 INTERRUPTION. The effect of some act or circumstance which stops the course of a prescription or act of limitation's. 2. Interruption of the use of a thing is natural or civil. 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
Three Months Ended, Twelve Months Ended,
------------------------- --------------------------
June 30, June 30, June 30, June 30,
2003 2002 2003 2002
------------------------- --------------------------
Revenues $7,279,839 $4,731,920 $19,518,274 $14,990,749
Operating
expenses:
Cost of sales 2,486,557 1,280,013 6,983,175 3,556,687
Research and
development 1,465,412 1,459,699 6,018,693 5,739,152
Sales and
marketing 3,409,861 3,028,860 13,433,861 10,275,913
Administrative 1,306,704 958,860 5,334,913 3,580,063
------------------------- --------------------------
8,668,534 6,727,432 31,770,642 23,151,815
------------------------- --------------------------
Loss from
operations (1,388,695) (1,995,512) (12,252,368) (8,161,066)
Interest income 94,314 262,347 574,395 1,257,171
------------------------- --------------------------
Loss before
income tax (1,294,381) (1,733,165) (11,677,973) (6,903,895)
Income tax expense - - - -
----------------------------------------------------
Net loss $(1,294,381) $(1,733,165) $(11,677,973) $(6,903,895)
====================================================
Weighted average
common shares
outstanding 14,215,846 14,154,312 14,174,594 14,084,313
Net loss per
common share $(0.09) $(0.12) $(0.82) $(0.49)
====================================================
BONE CARE INTERNATIONAL, INC.
Condensed Balance Sheets
June 30, 2003 June 30, 2002
-------------- --------------
ASSETS
Current Assets:
Cash and cash equivalents $3,065,218 $2,023,969
Marketable securities 13,624,826 18,436,896
Accounts receivable, net of allowance
for doubtful accounts of $111,200 and
$152,960 at June 30, 2003 and June
30, 2002, respectively 2,814,753 4,285,569
Inventories 2,080,604 2,099,469
Other current assets 778,725 775,596
-------------- --------------
Total current assets 22,364,126 27,621,499
Long-term securities 913,401 3,719,796
Property, plant, and equipment - at cost:
Leasehold improvements 588,632 588,632
Furniture and fixtures 545,547 452,345
Machinery and other equipment 3,100,108 2,317,405
-------------- --------------
4,234,287 3,358,382
Less accumulated depreciation and
amortization 2,345,287 1,573,497
-------------- --------------
1,889,000 1,784,885
Patent fees, net of accumulated
amortization of $1,131,952 at June 30,
2003 and $988,026 at June 30, 2002 1,322,670 1,198,249
Goodwill, net of accumulated amortization
of $1,000,752 as of June 30, 2003 and
June 30, 2002 359,165 359,165
-------------- --------------
$26,848,362 $34,683,594
============== ==============
BONE CARE INTERNATIONAL, INC.
Condensed Balance Sheets
Liabilities and Shareholders' Equity
June 30, 2003 June 30, 2002
-------------- --------------
Current Liabilities:
Accounts payable $2,684,838 $1,769,665
Accrued liabilities
Compensation payable 2,028,783 509,677
Accrued clinical study and
research costs 603,048 152,352
Accrued health and dental costs 101,863 -
Other 738 1,924
Allowance for sales returns 336,620 226,100
-------------- --------------
Total current liabilities 5,755,890 2,659,718
Long-term liabilities 649,880 -
Shareholders' 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 14,218,522 at June 30,
2003 and 14,156,722 at June 30, 2002 11,393,883 11,393,883
Additional paid-in capital 62,246,918 62,096,272
Accumulated deficit (53,198,209) (41,520,236)
Accumulated other comprehensive income
(loss) - 53,957
-------------- --------------
Total shareholders' equity 20,442,592 32,023,876
-------------- --------------
$26,848,362 $ 34,683,594
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