MGI PHARMA, INC. (NASDAQ:MOGN), an oncology- and acute care-
focused biopharmaceutical company, Minneapolis, Minn., has reported
total revenue for first quarter 2006 of $78.2 million. GAAP net loss for
the first quarter 2006 was $2.8 million, or $0.04 per diluted share. Pro
forma net loss for the first quarter of 2006 was $1.0 million, or $0.01
per diluted share, as is described below under "Reconciliation of
GAAP to Pro Forma Net Income (Loss)." At March 31, 2006, MGI
PHARMA's cash and marketable debt investments totaled $109.5
million.
"We executed on several important initiatives during recent
months that advance our portfolio of product candidates," said
Lonnie Moulder, president and CEO of MGI PHARMA. "The submission of
the NDA for Saforis and initiation of the Aquavan pivotal program were
key milestones for MGI PHARMA that move us forward toward our objective
of executing one product launch per year for the next three to four
years. With the May 15 PDUFA date for Dacogen just weeks away, we are
focused on our pre-launch activities in support of a potential product
launch."
First Quarter Results
Total revenues for the first quarter of 2006 were $78.2 million
compared to $63.2 million in the first quarter of 2005. Product sales
increased to $77.5 million in the first quarter of 2006 from $62.4
million in the first quarter of 2005. During the first quarter of 2006,
U.S. sales of Aloxi(R) (palonosetron hydrochloride) Injection totaled
$63.3 million compared to $57.2 million in the first quarter of 2005.
Sales of Gliadel(R) Wafer (polifeprosan 20 with carmustine implant)
totaled $9.7 million for the first quarter of 2006 compared to $7.3
million for the first quarter of 2005, when this product was being
marketed by Guilford Pharmaceuticals Inc.
Total costs and expenses were $82.8 million in the first quarter of
2006 compared to $51.0 million in the first quarter of 2005. Selling,
general and administrative expenses totaled $31.5 million in the first
quarter of 2006 compared to $18.8 million in the same period in 2005,
primarily due to the deployment and expansion of the acute care field
organization, investment in the Aloxi brand, and increased
administrative costs. Research and development expenses in the first
quarter of 2006 were $23.0 million, compared to $10.3 million in the
first quarter of 2005. The year-over-year increase in baseline R&D
expenses is primarily due to expenses related to our late stage clinical
development programs for Dacogen(TM) (decitabine) for Injection,
Aquavan(R) (fospropofol disodium) Injection and amolimogene (HPV E6 E7
plasmid).
The company reported a GAAP net loss of $2.8 million, or $0.04 per
diluted share, in the 2006 first quarter compared to net income of $11.6
million, or $0.15 per diluted share, in the 2005 first quarter. As
described below under "Reconciliation of GAAP to Pro Forma Income
(Loss)," pro forma net loss for the 2006 first quarter was $1.0
million, or $0.01 per diluted share, compared to pro forma net income of
$12.1 million, or $0.16 per diluted share, in the 2005 first quarter.
Reconciliation of GAAP to Pro Forma Net Income (Loss): GAAP refers
to generally accepted accounting principles in the U.S. MGI
PHARMA's pro forma net income (loss) and earnings (loss) per
diluted share exclude amortization of product acquisition intangible
assets, acquired in-process research and development expenses, and
license initiation and product candidate development milestone payments.
We are reporting pro forma results in addition to, and not as a
substitute for, financial measures calculated in accordance with GAAP.
The company provides these pro forma numbers to facilitate a comparison
of our business from period to period and to allow investors to analyze
our business results. We encourage investors to carefully consider our
results under GAAP, as well as our pro forma disclosures and the
reconciliation between these presentations to more fully understand our
business. Reconciliations between GAAP results and pro forma results are
presented at the end of this news release.
Recent Highlights
-- The scale up of the acute care sales team to approximately 75
associates is now complete. This team has been trained and is actively
promoting Aloxi within the hospital market. The company anticipates a
three-fold increase in hospital-focused sales force activity in support
of Aloxi and an impact on sales growth beginning in the second quarter
of 2006.
-- A direct-to-consumer advertising initiative for Aloxi remains on
track to begin during the second quarter with a print ad and Internet
campaign.
-- Launch preparations continue for Dacogen, which has a
Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2006. MGI
PHARMA expects to be prepared to commercialize this product within
several weeks of receiving FDA approval.
-- A phase 3 pivotal trial of Dacogen in elderly patients with
acute myeloid leukemia (AML) began during the first quarter of 2006.
This trial is part of a broad clinical development program for Dacogen,
which is also being evaluated in a phase 2 study of elderly patients
with AML, a phase 2 trial of an alternate dosing regimen in patients
with myelodysplastic syndromes (MDS), and a phase 3 EORTC-sponsored
trial in patients with MDS.
-- Following analysis of data from a phase 2 dose-ranging study of
Aquavan(R) Injection, a dose was selected to advance into a pivotal
program, which includes two pivotal trials and one safety study. Both
pivotal trials are now underway, and enrollment in this program is
expected to be complete by the end of 2006.
-- The New Drug Application (NDA) for Saforis has been submitted to
the U.S. FDA. Saforis is an investigational drug for the prevention and
treatment of oral mucositis in patients receiving mucotoxic cancer
therapy. One pivotal phase 3 trial and several supportive studies form
the foundation of the Saforis NDA. 2006 Corporate Objectives &
Milestones: This section and the "2006 Financial Outlook"
section which follows it provide forward-looking information about MGI
PHARMA's outlook for 2006 based upon our current operations. The
disclosure notice paragraph regarding forward-looking statements at the
end of this news release is especially applicable to these sections.
In 2006, MGI PHARMA is focused on building upon the commercial and
R&D progress made in 2005 by executing on key initiatives to advance
our development pipeline and grow product sales.
-- May 15, 2006 Dacogen PDUFA date
-- Advance the Dacogen pivotal AML program
-- Complete enrollment in the Dacogen ADOPT phase 2 MDS trial 3Q06
-- Complete enrollment in the Aquavan Injection pivotal program
4Q06
-- Complete 1st amolimogene (ZYC101a) pivotal trial 4Q06
-- Complete Aloxi Injection PONV pivotal program 4Q06
-- Complete Aloxi Capsule pivotal program 4Q06
-- Establish ex-U.S. commercialization paths for product candidates
2006 Pro Forma Financial Outlook
For the year ending December 31, 2006, the company continues to
expect the following:
-- Total revenue to be in the range of $370 to $385 million,
including the following:
-- Aloxi Injection sales of $285 to $300 million;
-- Gliadel Wafer sales of $40 million; and
-- Dacogen injection sales of $25 million, if approved by the FDA
during the second quarter;
-- Gross profit to be in the range of $245 to $258 million,
excluding $8 million of amortization of product acquisition intangible
assets;
-- SG&A expenses of $140 million;
-- Net R&D expenses of $88 million, excluding product candidate
development milestone payments of approximately $2 million and expenses
incurred for Symphony Neuro Development company, a non-majority owned
consolidated entity acquired in connection with the Guilford
acquisition, a majority of which are reversed as minority interest prior
to computing pre-tax income; and
-- Pro forma operating income from operations to be in the range of
$17 to $30 million.
This guidance excludes the impact of FASB 123R, which is expected
to be in the range of $8 to $10 million for the full year 2006.
About MGI PHARMA
MGI PHARMA, INC. is an oncology- and acute care-focused
biopharmaceutical company that acquires, researches, develops and
commercializes proprietary products that address the unmet needs of
patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride)
Injection and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant)
in the United States. The company directly markets its products in the
U.S. and collaborates with partners to reach international markets.
For more information, visit http://www.mgipharma.com or call
212/332-4381.
COPYRIGHT 2006 Worldwide
Videotex Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2006, Gale Group. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.