Excellent quarter from MOGN - this is my second biggest position after SEPR and the only position I have added to (just a little) in recent months. In general I've left my top three (SEPR, MOGN and ELN) pretty much unchanged and cut back across the board below them.
Press Release Source: MGI PHARMA, INC.
MGI PHARMA Reports Second Quarter Financial Results
Wednesday July 14, 7:00 am ET
Second Quarter Aloxi(TM) Injection Sales Total $37.1 Million; Aloxi(TM) Injection Guidance Revised Upwards to $140 to $150 Million for 2004
MINNEAPOLIS--(BUSINESS WIRE)--July 14, 2004-- MGI PHARMA, INC. (Nasdaq:MOGN - News) today announced that total revenue for the second quarter of 2004 was $47.9 million, including Aloxi(TM) (palonosetron hydrochloride) injection sales of $37.1 million. Net income for the second quarter was $8.6 million or $0.11 per diluted share. At June 30, 2004, MGI PHARMA's cash and marketable investments totaled $412.1 million.
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"We are very pleased to report another quarter of significant increases in Aloxi injection sales," said Lonnie Moulder, president and chief executive officer of MGI PHARMA. "We are focused on continuing this sales momentum as well as expanding our product portfolio through business development transactions."
Second Quarter Results
Sales increased to $46.9 million in the second quarter of 2004 from $8.5 million in the second quarter of 2003. During the second quarter of 2004, U.S. sales of Aloxi injection totaled $37.1 million and Salagen® Tablets (pilocarpine hydrochloride) were $8.6 million.
Total costs and expenses increased to $38.9 million in the second quarter of 2004 from $16.8 million in the second quarter of 2003. Selling, general and administrative expenses of $16.7 million for the second quarter of 2004 were higher than the same period in 2003 due to costs associated with the promotion of Aloxi injection. Research and development expenditures in the second quarter increased over the prior period in 2003 to $8.0 million, and included a $2.5 million milestone payment to Helsinn Healthcare SA related to successful achievement of an end of phase 2 milestone for Aloxi injection in post operative nausea and vomiting (PONV). The Company reported net income of $8.6 million, or $0.11 per diluted share, in the 2004 second quarter compared to a net loss of $7.0 million or $0.14 per share, in the 2003 second quarter.
Year-to-Date Results
For the first six months of 2004, total revenues increased to $74.8 million, including Aloxi injection sales of $55.7 million, compared to total revenues of $16.6 million in the first six months of 2003. Selling, general and administrative expenses of $34.1 million for the first six months of 2004 increased from $20.2 million in the same period in 2003 due to costs associated with the promotion of Aloxi injection. Research and development expenditures in the first half of 2004 increased to $13.0 million from $7.6 million in the first half of 2003. For the six months ended June 30, 2004, MGI PHARMA's net income was $5.4 million, or $0.07 per diluted share, compared to a net loss of $13.6 million, or $0.27 per share for the six months ended June 30, 2003.
Summary of Recent Developments
Aloxi(TM) Injection
MGI PHARMA markets Aloxi injection at a dose of 0.25 mg for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi injection is the first 5-HT3 receptor antagonist to be indicated for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic cancer chemotherapy. Since its commercial launch in mid-September of 2003, we estimate that approximately 440,000 Aloxi injection patient doses have been administered. During the second quarter, we estimate that approximately 265,000 vials of Aloxi injection were pulled through wholesaler and distributor channels to oncology clinics.
Other Highlights
As separately announced today, MGI PHARMA and Alpharma, Inc. entered into a promotion agreement for Kadian® (morphine sulfate sustained release capsules) under which MGI PHARMA will market Kadian in the United States to oncology health care professionals for moderate to severe pain associated with cancer.
As separately announced today, Eric Loukas, Esq. joined MGI PHARMA as vice president, general counsel and corporate secretary.
Hexalen® (altretamine) capsules were chosen as one of the oral cancer drugs that will be covered under the Medicare Drug Replacement Demonstration project beginning September 1, 2004 and continuing through December 31, 2005.
Three poster presentations at the Multinational Association of Supportive Care in Cancer (MASCC) 16th International Symposium described the impact of treatment with Aloxi injection on various quality-of-life parameters, the maintenance of efficacy of Aloxi injection in patients weighing more than 90 kilograms, and the pharmacokinetics and safety of repeat doses of Aloxi injection.
At the 40th Annual Meeting of the American Society of Clinical Oncology (ASCO), Aloxi injection was the subject of two poster presentations and one published abstract describing combination data with aprepitant, efficacy in elderly patients, and evaluation of a potential carryover effect. In addition, one poster presentation and two published abstracts described activity of irofulven in hormone refractory prostate cancer, hepatocellular carcinoma, and metastatic colorectal cancer.
In April, MGI PHARMA and Helsinn Healthcare SA successfully achieved an end of phase 2 milestone related to Aloxi injection in post-operative nausea and vomiting (PONV).
MGI PHARMA's Board of Directors approved a two-for-one stock split of the Company's common stock. The stock began trading on a post-split basis on June 10, 2004.
A phase 2 trial of irofulven in combination with prednisone and capecitabine was initiated in hormone refractory prostate cancer patients.
Financial Outlook for 2004
This section provides forward-looking information about MGI PHARMA's updated financial outlook for 2004 for our current operations, including the impact of the Kadian promotion agreement. For the year ending December 31, 2004, we currently expect:
Aloxi injection product sales to range from $140 million to $150 million and all other product sales to be approximately $27 million;
Cost of product sales as a percent of sales for currently marketed products to be approximately 31 percent;
Licensing revenue to total approximately $3 million;
Selling, general and administrative expenses to be approximately $65 million;
R&D expense to be approximately $24 million, inclusive of milestones associated with current product candidates; and
Pre-tax income of approximately $30 million, using the midpoint of the Aloxi injection sales range.
Business development and licensing activities resulting in expansion of our product portfolio would likely require us to update this financial guidance and may increase our expenses and decrease net income for 2004. The disclosure notice paragraph regarding forward-looking statements at the end of this news release is especially applicable to this section.
Conference Call & Webcast Information
MGI PHARMA will broadcast its quarterly investor conference call live over the Internet today, Wednesday, July 14, 2004 at 1:00 p.m. Eastern Time. The Company's executive management team will review 2004 second quarter financial results, discuss operations and the Kadian promotion agreement, and provide guidance on MGI PHARMA's business outlook. All interested parties are welcome to access the webcast via the Company's Web site at www.mgipharma.com. The audio webcast will be archived on the Company's Web site for a limited period of time.
Incidentally, as Ward pointed out to me today, he and I forecast the company's current sales target some time back:
Message 19907920
Peter |
