Bone Care International, Inc. (NASDAQ: BCII), Middleton, Wis., has
announced that total revenues for the first quarter ended September 30,
2002 increased to $5.4 million from $2.6 million in the quarter ended
September 30, 2001. Hectorol(R) Injection sales increased to $4.2
million in the current quarter from $1.0 million in the first quarter of
the prior fiscal year. Bone Care reported a net loss of $1.6 million, or
$0.12 per share for the quarter ended September 30, 2002, compared to a
net loss of $2.1 million, or $0.15 per share for the quarter ended
September 30, 2001.
Gross margins for the quarter ended September 30, 2002, were $3.9
million, or 72% of revenues compared to $2.1 million, or 78% of revenues
in the quarter ended September 30, 2001. Bone Care has increased
expenditures for quality assurance and compliance directed toward
resolving manufacturing issues with the current supplier of Hectorol
Injection and validating an additional supplier. Based on discussions
with the FDA, Bone Care intends to follow an accelerated submission
pathway for both of these contract manufacturers once they complete
validation lots. Each manufacturer must receive FDA clearance before
Bone Care can commercially release its product. In the event Bone Care
does not receive additional commercial supply of Hectorol Injection
prior to the year end, revenues will be approximately $4 million in the
December 2002 quarter.
Paul Berns, president and CEO, commenting on the manufacturing
issues, said, "We are encouraged by the progress we have made with
both contract manufacturers and our recent discussions with the FDA. Our
goal remains to receive additional commercial supply of Hectorol
Injection in the December 2002 quarter. Although we cannot at this point
give assurance that we will meet that goal, we believe that we will have
commercial supply of Hectorol Injection from one or both of our contract
manufacturers no later than the first quarter of 2003. We are
simultaneously managing current inventory levels to support our supplier
channels. As always, our commitment is to support the needs of our
end-users, the clinics and patients that rely on Hectorol Injection and
to commence production as soon as possible."
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, and other diseases including
psoriasis and cancers of the prostate, breast and colon.
For more information, call 608/662-7815.
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