ImClone Systems Incorporated (NASDAQ: IMCL), New York, has
announced its financial results for the quarter and six months ended
June 30, 2006.
Total revenues for the second quarter of 2006 were $149.9 million
as compared with $92.4 million for the second quarter of 2005, an
increase of 62%.
-- Royalty revenue of $74.6 million in the second quarter of 2006
compared with $41.8 million in the second quarter of 2005, an increase
of 79%. Royalty revenue for the second quarter of 2006 includes 39% of
Bristol-Myers Squibb's in-market ERBITUX net sales of $172.8
million, compared with second quarter 2005 in-market net sales of $97.9
million, an increase of 77%, and first quarter 2006 net sales of $138.0
million, an increase of 25%. These in-market sales, reflecting a
drop-ship distribution methodology, represent ERBITUX shipments to
end-user accounts only, with no wholesaler stocking;
-- License fees and milestone revenue of $33.5 million in the
second quarter of 2006 compared with $24.5 million in the second quarter
of 2005;
-- Manufacturing revenue of $28.4 million in the second quarter of
2006 compared with $7.9 million in the second quarter of 2005. The
year-to-year increase principally reflects an increase in volume
purchases by Bristol-Myers Squibb. Purchases by Bristol-Myers Squibb are
timed at their discretion to accommodate forecasts and safety stock
needs, and are not necessarily indicative of historical in-market sales
or future sales expectations; and
-- Collaborative agreement revenue of $13.4 million in the second
quarter of 2006 compared with $18.2 million in the second quarter of
2005. The year-to-year decrease principally reflects a reduction in
clinical materials shipped to Merck KGaA versus the prior year. Total
operating expenses for the second quarter of 2006 were $110.8 million
(or $108.6 million excluding the effects of stock options expenses as
determined in accordance with FAS123R of $2.2 million), compared with
$71.3 million in the second quarter of 2005. Operating expenses
included:
-- Research and development expenses for the second quarter of 2006
were $27.6 million (or $27.1 million excluding FAS123R expense of $.5
million), compared with $24.4 million in the second quarter of 2005. The
year-to-year increase reflects higher third-party expenses to
manufacture clinical supplies of pipeline products, the commencement of
depreciation associated with the company's BB50 manufacturing
facility, and higher occupancy costs attributable to utility expenses;
-- Clinical and regulatory expenses in the second quarter of 2006
were $14.9 million (or $14.6 million excluding FAS123R expense of $.3
million), compared with $8.4 million in the second quarter of 2005. The
increase principally reflects higher clinical trial expenses associated
with ERBITUX and the company's pipeline;
-- Marketing, general and administrative expenses were $23.0
million in the second quarter of 2006 (or $21.6 million excluding
FAS123R expense of $1.4 million), compared with $16.8 million in the
second quarter of 2005, reflecting additional sales and marketing
expenses associated with the launch of ERBITUX in head and neck cancer;
-- Royalty expenses were $18.4 million in the second quarter of
2006 compared with $14.3 million in the second quarter of 2005 as the
result of higher sales. Approximately $9.2 million of the 2006 expenses
were reimbursed as a component of collaborative agreement revenue,
resulting in net royalty expenses of $9.2 million for the second quarter
of 2006 compared with $9.3 million in the second quarter of last year;
and
-- Cost of manufacturing revenue was $26.9 million in the second
quarter of 2006 compared with $1.1 million in the second quarter of last
year. These costs represent fully absorbed manufacturing costs in 2006,
as substantially all previously expensed material has been sold through
to our partners.
Operating income in the second quarter of 2006 was $39.1 million
compared with $21.1 million in the second quarter of last year.
Operating income for the second quarter as well as the first six months
of 2006 was positive excluding the revenue from amortization of license
fees and milestones.
Our estimate of the effective tax rate for the full year has been
revised to 15%, resulting in an effective rate in the second quarter of
2006 of 21%. These estimated rates exclude the release of a portion of
the company's tax valuation allowance in the first quarter of 2006.
This estimate for the quarter and full-year rates is higher than the
company's previous estimate of 13%, reflecting higher projected
income for the full-year 2006 than previously estimated, including the
taxability of the up-front payment from Merck KGaA referenced in the
company's recent announcement. The effective tax rate in the second
quarter of 2005 was less than 1%.
Net income for the second quarter of 2006 was $37.2 million
compared with $26.0 million in the second quarter of last year. Diluted
earnings per share were $.42 in the second quarter of 2006 compared with
$.30 in the second quarter of 2005.
Total revenues and net income for the six months ended June 30,
2006 were $395.0 million and $266.8 million, respectively, compared with
$178.2 million and $54.9 million in the first six months of last year.
Diluted earnings per share were $2.93 for the first six months of 2006
compared with $.63 for the first six months of 2005. The results for the
first six months of 2006 include the receipt of the $250 million
milestone from Bristol-Myers Squibb and the partial release of the tax
valuation allowance mentioned above.
To provide investors with a clearer picture of the company's
growth versus last year, a reconciliation of non-GAAP diluted earnings
per share to diluted earnings per share prepared in accordance with GAAP
is set forth below. For 2006, non-GAAP diluted earnings per share for
the quarter exclude the effects of FAS123R and, for the six months
year-to-date, exclude the effects of both FAS123R and the one-time tax
benefit associated with the release of a portion of the company's
deferred asset valuation allowance reported in the first quarter of
2006. For 2005, non-GAAP diluted earnings per share for the second
quarter and first six months exclude expenses associated with the
discontinuance of the company's small molecule research operation.
About ImClone Systems Incorporated
ImClone Systems Incorporated is committed to advancing oncology
care by developing and commercializing a portfolio of targeted biologic
treatments designed to address the medical needs of patients with a
variety of cancers. The company's research and development programs
include growth factor blockers and angiogenesis inhibitors. ImClone
Systems' strategy is to become a fully integrated biopharmaceutical
company, taking its development programs from the research stage to the
market. ImClone Systems' headquarters and research operations are
located in New York City, with additional administration and
manufacturing facilities in Branchburg, New Jersey.
For more information, call 646/638-5058.
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