MGI PHARMA Reports 2001 Financial Results and Provides 2002 Guidance; Progress Continues With Both Phase 3 Oncology Product Candidates.Business Editors & Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--Feb. 13, 2002 MGI MGI Mouse Genome Informatics MGI Modular Gateway Interface MGI McKinsey Global Institute MGI Military Geographic Information MGI Marine Geological Institute MGI Policy on the Management of Government Information (Canada) PHARMA, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. ., (Nasdaq:MOGN) 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 antagonist /an·tag·o·nist/ (an-tag´o-nist) 1. a substance that tends to nullify the action of another, as a drug that binds to a cell receptor without eliciting a biological response, blocking binding of substances that could for the prevention of chemotherapy-induced nausea and vomiting Nausea and Vomiting Definition Nausea is the sensation of being about to vomit. Vomiting, or emesis, is the expelling of undigested food through the mouth. . 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 pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. 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(R) Tablets (pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). hydrochloride hydrochloride /hy·dro·chlo·ride/ (-klor´id) a salt of hydrochloric acid. hy·dro·chlo·ride n. A compound resulting from the reaction of hydrochloric acid with an organic base. ) and Hexalen(R) 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 Sjö·gren's syndrome n. A syndrome occurring in menopausal women, characterized by keratoconjunctivitis sicca, dryness of mucous membranes, telangiectasias or purpuric spots on the face, and bilateral parotid enlargement; it is often associated with , an autoimmune disease autoimmune disease, any of a number of abnormal conditions caused when the body produces antibodies to its own substances. In rheumatoid arthritis, a group of antibody molecules called collectively RF, or rheumatoid factor, is complexed to the individual's own gamma of the salivary glands salivary glands (săl`əvâr'ē), in humans, three pairs of glands that secrete the alkaline digestive fluid, saliva, into the mouth. , and radiation therapy for head and neck cancer. Hexalen Capsules are MGI's oral chemotherapy for the treatment of refractory refractory Material that is not deformed or damaged by high temperatures, used to make crucibles, incinerators, insulation, and furnaces, particularly metallurgical furnaces. ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast . 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 North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe for the prevention of chemotherapy-induced nausea and vomiting (CINV CINV Chemotherapy Induced Nausea and Vomiting ). 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 Of Montreal is an American indie pop band formed in Athens, Georgia, fronted by Kevin Barnes. It was among the second wave of groups to emerge from The Elephant 6 Recording Company. , Canada, are developing MG98 for the purpose of blocking production of DNA methyltransferase In biochemistry, the DNA methyltransferase (DNA MTase) family of enzymes catalyze the transfer of a methyl group to DNA. DNA methylation serves a wide variety of biological functions. All the known DNA methyltransferases use S-adenosyl methionine (SAM) as the methyl donor. , which may allow tumor suppressor genes tumor suppressor gene n. A gene that suppresses cellular proliferation. When inherited in a mutated state, it is associated with the development of various cancers, including most familial cancers. Also called antioncogene. 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 antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid). inhibitor of DNA methyltransferase, in patients with advanced myelodysplastic syndrome Myelodysplastic Syndrome Definition Myelodysplastic syndrome (MDS) is a disease that is associated with decreased production of blood cells. Blood cells are produced in the bone marrow, and the blood cells of people with MDS do not mature normally. (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ) or relapsed/refractory acute myeloid leukemia myeloid leukemia n. See myelogenous leukemia. (AML AML - A Manufacturing Language ). 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 British Biotech was a British based biotech company. British Biotechnology Limited was founded in 1986 by former G D Searle managers Keith McCullagh and Brian Richards, [1] plc announced that they have entered into a collaboration granting British Biotech bi·o·tech n. Informal Biotechnology. biotech Noun short for biotechnology Noun 1. 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 An earlier Windows PIM from NetManage, Inc., Cupertino, CA (www.netmanage.com). ECCO provided a phone book, calendar, to-do list, outlining and notetaking. It was noted for its tightly integrated and sophisticated functions. Conference in October; -- Irofulven and MG98 data were presented at the AACR-NCI-EORTC Symposium in November; -- Salagen(R) Tablets data were presented by the Radiation Therapy Oncology Group (RTOG RTOG Radiation Therapy Oncology Group RTOG Round Table of Goodness (diecast toy car collecting club) ) at the annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO) in November; and -- Dr. S Dr. Doctor. dr. dram. . 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 Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). of approximately $31 million from the sale of approximately 3 million shares of common stock in a private placement with institutional investors Institutional Investor A non-bank person or organization that trades securities in large enough share quantities or dollar amounts that they qualify for preferential treatment and lower commissions. . 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 You can assist by [ editing it] now. Piper Jaffray Piper Jaffray & Co. (NYSE: PJC), often shortened to just Piper Jaffray or PiperJaffray, is a U.S. middle-market investment banking firm based in Minneapolis, Minnesota and is a focused on delivering financial advice, investment products and transaction execution 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 United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , one of our goals for 2002. The disclosure notice paragraph regarding forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 Top 100 Biotechnology Companies The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities , 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 Form 10-Q See 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
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