Bone Care International, Inc. Announces Fourth Quarter Results.MADISON, Wis.--(BUSINESS WIRE)--Aug. 5, 1999-- Bone Care International, Inc. (NASDAQ: BCII BCII - Battle Command and Intelligence Integration) today announced a net loss of $1,213,000, or $0.12 per share, in the quarter ended June 30, 1999 compared with a net loss of $1,125,000, or $0.13 per share, for the quarter ended June 30, 1998. For the year ended June 30, 1999, the net loss was $5,777,000, or $0.57 per share, compared with a net loss of $4,490,000, or $0.51 per share, for the year ended June 30, 1998. Losses increased primarily due to ongoing preparations for the U.S. launch of Bone Care's lead product, Hectorol(TM) (doxercalciferol doxercalciferol /dox·er·cal·cif·er·ol/ (dok?ser-kal-sif´er-ol) a synthetic analogue of vitamin D, used to reduce levels of circulating parathyroid 1. situated beside the thyroid gland. 2. see under gland. par·a·thy·roid (p r hormone in the treatment of secondary hyperparathyroidism hyperparathyroidism /hy·per·para·thy·roid·ism/ (-par?ah-thi´roid-izm) excessive activity of the parathyroid glands. Primary h. is associated with neoplasia or hyperplasia; the excess of parathyroid hormone parathyroid hormone or parathormone, a hormone secreted by the parathyroid glands that regulates the metabolism of calcium and phosphate in the body. It has been purified extensively and appears to be a protein containing 84 amino-acid residues, a sequence of which about 33 to 35 are necessary for biological activity. leads to alteration in function of bone cells, renal tubules, and gastrointestinal mucosa. Secondary h. occurs when the serum calcium tends to fall below normal, as in chronic renal disease, etc. Tertiary h. associated with chronic renal failure.)
Capsules. This new vitamin D-hormone therapy was approved by the United
States Food and Drug Administration (FDA) on June 9, 1999, for the
management of secondary hyperparathyroidism (SHPT SHPT - Senior Health Physics Technician) in kidney dialysis
patients. Bone Care currently is building a sales force to market and
sell Hectorol Capsules, and expects to begin product sales in October
1999.SHPT is an undertreated, chronic condition in which excessive blood levels of parathyroid hormone (PTH) contribute to the development of debilitating bone diseases. This condition is commonly diagnosed in kidney dialysis patients, which number approximately 250,000 in the U.S. It also is diagnosed in other, larger patient populations, including pre-dialysis and osteoporosis patients. Bone Care plans to continue development of Hectorol for these larger markets. In June 1999, Bone Care signed a letter of intent with a Japanese pharmaceutical company which sets out the terms under which it will license exclusive rights to Hectorol for Japan, the world's largest market for vitamin D-hormone therapies. The parties are currently negotiating the terms of a definitive agreement, which are expected to include milestone payments and ultimately royalties to Bone Care. Bone Care received a payment of $125,000 upon signing the letter of intent. Bone Care is actively pursuing license agreements with other companies for marketing rights to Hectorol in the remaining major pharmaceutical markets of the world. Research and development expenses decreased from prior year levels as synthesis and formulation research related to Hectorol Capsules was completed. Marketing, general, and administrative expenses have progressively increased during the current year as Bone Care expanded pre-marketing activities associated with the upcoming launch of Hectorol Capsules. In February 1999, Bone Care submitted a second New Drug Application (NDA) to the FDA for intravenous Hectorol (Hectorol Injection) for the same indication as Hectorol Capsules. The FDA has not yet accepted this NDA for review and continues to request additional information as a condition for acceptance, which we intend to provide promptly. Clinical investigators presented the results of the pivotal Phase 3 trials at the 1998 annual meetings of the American Society of Nephrology and the American Society of Bone and Mineral Research. They reported that Hectorol Injection, like Hectorol Capsules, effectively reduces blood parathyroid hormone levels without significant side effects. Our 1999 Annual Meeting of Shareholders will be held on November 17, 1999. Accordingly, a shareholder proposal or nomination intended to be brought before the 1999 Annual Meeting must be received by the Assistant Secretary on or after August 19, 1999, and on or prior to September 17, 1999. Bone Care International is a pharmaceutical company which is developing vitamin D-hormone therapies with improved safety and efficacy profiles for treatment of a) secondary hyperparathyroidism associated with end-stage renal disease and pre-dialysis renal disease, b) osteoporosis, c) psoriasis, and d) cancers of the breast, prostate, and colon.
BONE CARE INTERNATIONAL, INC.
Consolidated Statements of Income
(Unaudited)
Three Months Ended
-----------------------------
June 30, June 30,
1999 1998
-----------------------------
Revenues $ -- $ --
Operating expenses
Research and development 717,607 870,225
Marketing, general and
administrative 591,218 309,898
---------- ----------
1,308,825 1,180,123
---------- ----------
Loss from operations (1,308,825) (1,180,123)
Interest income 96,279 55,166
---------- ----------
Net loss $ (1,212,546) $ (1,124,957)
========== ==========
Net loss per common share $(0.12) $(0.13)
========== ==========
Weighted average number of
common shares 10,156,714 8,782,857
========== ==========
BONE CARE INTERNATIONAL, INC.
Consolidated Statements of Income
Year Ended
--------------------------------
June 30, June 30,
1999 1998
--------------------------------
Revenues $ -- $ --
Operating expenses
Cost of sales -- --
Research and development 3,455,401 3,932,008
Marketinging, general
and administrative 2,854,785 898,274
---------- ----------
6,310,186 4,830,282
---------- ----------
Loss from operations (6,310,186) (4,830,282)
Interest income 533,571 340,349
---------- ----------
Net loss $ (5,776,615) $ (4,489,933)
========== ==========
Net loss per common share $(0.57) $(0.51)
========== ==========
Weighted average number of
common shares 10,055,327 8,746,677
========== ==========
BONE CARE INTERNATIONAL, INC.
Consolidated Balance Sheets
June 30, 1999 June 30, 1998
------------- -------------
Assets
Current assets:
Cash and cash equivalents $ 7,313,551 $ 3,484,374
Inventory 1,119,262 229,500
Other current assets 110,017 50,162
---------- ----------
Total current assets 8,542,830 3,764,036
Property, plant, and
equipment - net 309,592 310,088
Intangible assets - net 1,400,706 1,366,317
Other non-current assets 50,133 372,835
---------- ----------
Total Assets $ 10,303,261 $ 5,813,276
========== ==========
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 202,686 $ 59,585
Accrued clinical study
and research costs 171,988 481,005
Other current liabilities 211,788 150,705
---------- ----------
Total current liabilities 586,462 691,295
Shareholders' equity 9,716,799 5,121,981
---------- ----------
Total Liabilities and
Shareholders' Equity $ 10,303,261 $ 5,813,276
========== ==========
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