Going to archive this since Yahoo! links expire . . .
>>MINNEAPOLIS--(BUSINESS WIRE)--Feb. 13, 2002--MGI PHARMA, INC., (Nasdaq:MOGN - news) today reported that annual revenues increased 31 percent to $33.0 million in 2001 from $25.2 million in 2000. The 2001 net loss of $34.8 million, or $1.74 per share, compared to a 2000 net loss of $19.5 million, or $1.22 per share, including the $9.4 million cumulative effect of the change in accounting principle for Staff Accounting Bulletin No. 101 on Revenue Recognition. At December 31, 2001, MGI PHARMA's cash and marketable investments totaled $77.7 million.
``We are pleased to report that our fiscal 2001 results represent continued growth in product sales for MGI PHARMA,'' commented Chuck Blitzer, president and chief executive officer of MGI. ``2001 was yet another year of growth in many ways for our Company. Most exciting is our continued progress in the development of our two late-stage oncology products, palonosetron and irofulven. We recently announced the completion of the Phase 3 program for palonosetron, our potent 5-HT3-receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting. We're also pleased to continue our progress with the clinical development of irofulven, our novel anti-cancer compound in Phase 3 development for pancreatic cancer patients. We look forward to continued momentum with both of these product candidates in 2002 as well as continuing progress toward our goal of becoming a leader in oncology.''
Additional Annual Results
Total annual sales revenues increased 41 percent to $30.0 million in 2001 from $21.3 million in 2000. Sales growth in MGI's Salagen® Tablets (pilocarpine hydrochloride) and Hexalen® Capsules (altretamine) was due to a combination of increases in underlying demand, stocking of inventory in distribution channels and increases in unit selling prices. Total annual costs and expenses increased 86 percent to $69.4 million in 2001 from $37.3 million in 2000. This increase includes increased research and development expenses for our oncology product candidates, including $13 million of license fees for palonosetron rights, one of our two product candidates in Phase 3 development. The increase in costs and expenses also includes increased selling, general and administrative expenses related to our expanded business objectives, including the initiation of active field promotion of two oncology products in March 2001.
Salagen Tablets are the Company's primary commercial product approved to treat the symptoms of dry-mouth caused by Sjogren's syndrome, an autoimmune disease of the salivary glands, and radiation therapy for head and neck cancer. Hexalen Capsules are MGI's oral chemotherapy for the treatment of refractory ovarian cancer.
Quarterly Results
MGI PHARMA reported that total revenues increased 16 percent to $7.4 million in the 2001 fourth quarter from $6.4 million in the fourth quarter a year ago. Total costs and expenses increased 64 percent to $18.0 million in the 2001 fourth quarter from $11.0 million in the 2000 fourth quarter. The Company further reported a net loss of $10.2 million, or $0.44 per share, in the fourth quarter of 2001 compared to a net loss of $4.0 million, or $0.25 per diluted share, in the fourth quarter of 2000.
Summary of Recent Developments
Palonosetron Update
Palonosetron is a potent, highly selective 5-HT3-receptor antagonist with an extended half-life, in development in North America and Europe for the prevention of chemotherapy-induced nausea and vomiting (CINV). Recent highlights include:
After the close of the quarter, MGI along with its partner HELSINN Healthcare SA of Lugano, Switzerland, announced the completion of the Phase 3 program for palonosetron, which comprised four distinct trials. Patient treatment is completed and the data analysis is underway for the pivotal Phase 3 trials. Submission of a New Drug Application for palonosetron in the U.S. is planned to occur in the third quarter of 2002.
Irofulven Update
Irofulven, a promising new compound with a unique mechanism of action and demonstrated activity in a variety of cancers, is the first product candidate being developed by MGI from its family of proprietary anti-cancer compounds called acylfulvenes. During the fourth quarter of 2001, the Company made continued progress in the clinical development program for irofulven. Highlights include the following:
Enrollment to date in the pivotal Phase 3 trial of irofulven for the treatment of advanced pancreatic cancer is consistent with achieving the goal of full enrollment in the third quarter of 2002.
During the fourth quarter, MGI announced the expansion of its Phase 2 clinical trial of irofulven in ovarian cancer based on seeing the requisite measurable anti-tumor activity using the every-other-week dosing schedule of irofulven. The completion of patient enrollment for this expanded Phase 2 trial is expected to occur in 2002.
Also during the quarter, MGI announced the expansion of its ongoing Phase 2 clinical trial of irofulven for patients with unresectable hepatocellular carcinoma (inoperable liver cancer). The trial expansion criterion was met with a confirmed objective partial response (greater than 50 percent tumor shrinkage) observed in a liver cancer patient, resulting in this Phase 2 trial being expanded to treat additional patients. Patient enrollment for this expanded Phase 2 trial is expected to be completed in 2002, and an additional Phase 2 trial of irofulven for liver cancer patients is anticipated to begin in early 2002 using the every-other-week dosing schedule of the drug.
MG98 Update
MGI and its partner MethylGene Inc., of Montreal, Canada, are developing MG98 for the purpose of blocking production of DNA methyltransferase, which may allow tumor suppressor genes that have been silenced by hypermethylation to be re-activated.
After the close of the quarter, MGI and MethylGene initiated a Phase 1 / 2 clinical trial of MG98, a second-generation antisense inhibitor of DNA methyltransferase, in patients with advanced myelodysplastic syndrome (MDS) or relapsed/refractory acute myeloid leukemia (AML). This trial will assess the safety and pharmacokinetic profiles of MG98, define the optimal effective dose of MG98 in these patients -- which will aid in the design of future MG98 trials -- and document both the biological and clinical effects of MG98 in patients with advanced MDS and relapsed or refractory AML. Phase 2 clinical trials of MG98 in head and neck cancer and in renal cell carcinoma are ongoing.
Yesterday, MethylGene and British Biotech plc announced that they have entered into a collaboration granting British Biotech the European development and commercialization rights for MG98. MGI welcomes the opportunity to add British Biotech's drug development expertise and resources to the collaborative development of MG98.
MGI PHARMA Participation at Fall 2001 Medical Meetings
Data on MGI's product candidates were presented at numerous scientific and medical meetings during fourth quarter, including:
A presentation entitled Irofulven - A New Anti-Tumor Agent was given in October by Dr. Ray Taetle, one of the inventors of irofulven, at The 5th Annual Fall Oncology Conference - Advances in Solid Tumors;
MG98 pre-clinical data were presented at the AACR-sponsored Epigenetics in Cancer Meeting in October;
Irofulven Phase 1 data were presented at the ECCO Conference in October;
Irofulven and MG98 data were presented at the AACR-NCI-EORTC Symposium in November;
Salagen® Tablets data were presented by the Radiation Therapy Oncology Group (RTOG) at the annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in November; and
Dr. S. Gail Eckhardt, a key irofulven investigator, gave a presentation on Pre-clinical and Clinical Activity of Irofulven in Pancreatic Cancer at the Chemotherapy Foundation Symposium in November.
Financing
During the fourth quarter, MGI completed two financings to raise additional capital. In October, the Company received net proceeds of approximately $31 million from the sale of approximately 3 million shares of common stock in a private placement with institutional investors. In November, the Company received net proceeds of approximately $11.8 million from the sale of 900,000 shares of common stock to U.S. Bancorp Piper Jaffray Inc.
2002 Financial Outlook
This section provides forward-looking information about MGI PHARMA's financial outlook for 2002. These projections do not include the impact of out-licensing commercial rights for irofulven outside the United States, one of our goals for 2002. The disclosure notice paragraph regarding forward-looking statements at the end of this news release is especially applicable to this section.
For the year ended December 31, 2002, we currently expect:
Product sales to be approximately $30 million,
Cost of product sales as a percent of sales revenue to range from 10 to 15 percent,
Licensing revenue to be approximately $3 million,
R&D expense to be approximately $45 million and is dependent on the timing of palonosetron milestone achievements and the pace of irofulven and MG98 development,
Selling, general and administrative expenses to be approximately $29 million,
Amortization expense related to the acquisition of Hexalen Capsules to be approximately $1.2 million,
Net loss to be approximately $45 million, and
Cash use of approximately $40 million.
Webcast of Fourth Quarter Conference Call
MGI PHARMA's 2001 fourth quarter conference call will be broadcast live over the Internet on Wednesday, February 13, 2002 at 1:00 p.m. Eastern Time. The Company's executive management team will review year-end 2001 financial results, answer questions from analysts and investors, and provide commentary on MGI's product portfolio and business outlook. Interested parties may access the webcast via the corporate information section of MGI's web site at www.mgipharma.com .
About MGI PHARMA
MGI PHARMA, Inc. is an oncology-focused pharmaceutical company that acquires, develops and commercializes proprietary products that address unmet cancer patient needs. MGI is building a balanced product portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. The Company focuses its sales efforts solely in the United States and collaborates with other pharmaceutical or biotechnology companies for its products in international markets. For more information about MGI, please visit the Company's Web site at www.mgipharma.com.
This news release contains certain ``forward-looking'' statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as ``believes,'' `` expects,'' ``anticipates,'' ``intends,'' ``will,'' ``may,'' ``should,'' or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the Company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission including in Exhibit 99 to its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements to conform them to actual results.
MGI PHARMA, INC.
Statements of Operations
(Unaudited)
Three Months Ended Year Ended
December 31, December 31,
-------------------------- --------------------------
2000 2001 2000 2001
------------ ------------ ------------ ------------
Revenues:
Sales $ 5,773,168 $ 6,883,990 $ 21,333,229 $ 30,021,813
Promotion 0 0 769,874 0
Licensing 632,425 532,376 3,109,470 2,932,007
------------ ------------ ------------ ------------
6,405,593 7,416,366 25,212,573 32,953,820
------------ ------------ ------------ ------------
Costs and Expenses:
Cost of sales 597,936 1,054,539 1,626,833 3,632,767
Selling,
general &
administrative 5,667,498 8,135,790 18,294,757 28,463,387
Research and
development 4,636,485 8,550,795 17,241,217 36,101,373
Amortization 98,498 295,494 98,498 1,181,978
------------ ------------ ------------ ------------
11,000,417 18,036,618 37,261,305 69,379,505
------------ ------------ ------------ ------------
Loss before
interest and
taxes $ (4,594,824) $(10,620,252) $(12,048,732) $(36,425,685)
Interest income 546,324 371,455 2,145,553 1,600,363
------------ ------------ ------------ ------------
Loss before
taxes (4,048,500) (10,248,797) (9,903,179) (34,825,322)
Provision for
income taxes 0 0 148,000 0
------------ ------------ ------------ ------------
Net loss before
cumulative effect
of change in
accounting
principle $ (4,048,500) $(10,248,797) $(10,051,179) $(34,825,322)
------------ ------------ ------------ ------------
Cumulative
effect of change
in accounting
principle $ 0 $ 0 $ (9,402,643) $ 0
------------ ------------ ------------ ------------
Net loss $ (4,048,500) $(10,248,797) $(19,453,822) $(34,825,322)
============ ============ ============ ============
Three Months Ended Year Ended
December 31, December 31,
----------------------- -----------------------
2000 2001 2000 2001
----------- ---------- ----------- ----------
Loss per common share:
Basic
Loss from continuing
operations $ (0.25) (0.44) $ (0.63) (1.74)
Cumulative effect of
accounting change 0.00 0.00 (0.59) 0.00
----------- ---------- ----------- ----------
Net loss $ (0.25) (0.44) $ (1.22) (1.74)
=========== ========== =========== ==========
Assuming dilution
Loss from continuing
operations $ (0.25) (0.44) $ (0.63) (1.74)
Cumulative effect of
accounting change 0.00 0.00 (0.59) 0.00
----------- ---------- ----------- ----------
Net loss $ (0.25) (0.44) $ (1.22) (1.74)
=========== ========== =========== ==========
Weighted average
number of common shares:
Basic 16,470,087 23,347,659 15,990,459 19,985,192
Assuming dilution 16,470,087 23,347,659 15,990,459 19,985,192
Balance Sheet Data
(Unaudited)
December 31, December 31,
2000 2001
----------- -----------
Cash and marketable investments $29,898,787 $77,712,480
Total assets 52,743,570 97,668,023
Total stockholders' equity 26,045,617 68,934,711<<
Cheers, Tuck |
