MGI PHARMA Reports 2001 Second Quarter Results.Business Editors MINNEAPOLIS--(BUSINESS WIRE)--July 18, 2001 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 total revenues increased 51 percent to $11.0 million in the quarter ended June 30, 2001 from $7.3 million in the corresponding period a year ago. Total costs and expenses increased to $13.7 million from $7.3 million in the second quarter of 2000, excluding license fees for palonestron, the Company's novel and highly selective 5-HT3 receptor antagonist A receptor antagonist is a drug that does not provoke a biological response itself upon binding to a receptor, but blocks or attenuates agonist-mediated responses. It may be competitive (or surmountable), i.e. in Phase 3 development 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. (CINV CINV Chemotherapy Induced Nausea and Vomiting ). Including this charge, total costs and expenses were $26.8 million in the second quarter of 2001. The Company reported a net loss of $15.4 million for the second quarter of 2001, or $0.81 per share, compared to net income of $0.5 million, or $0.03 per diluted di·lute tr.v. di·lut·ed, di·lut·ing, di·lutes 1. To make thinner or less concentrated by adding a liquid such as water. 2. To lessen the force, strength, purity, or brilliance of, especially by admixture. share in the second quarter of 2000. Record growth in sales was due to a combination of continued growth in demand for 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 a substantial increase in its distribution channel inventory, as well as sales of new products. Product sales revenue increased 66 percent to $10.2 million in the second quarter of 2001, from $6.1 million in the second quarter of 2000. 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, and accounted for 92 percent of overall product sales in the second quarter of 2001. "In addition to the strong sales we recorded during the quarter, we made substantial strides in the development of irofulven, our novel anti-cancer compound, through the initiation of a number of new clinical trials and the Fast Track designation we recently received from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ," commented Chuck Blitzer, president and chief executive officer of MGI PHARMA. "We also formally signed the license arrangement for palonosetron and completed a substantial financing during this quarter. We now look forward to the continued advancement of our oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. pipeline, including the Phase 3 programs for both palonosetron and irofulven." In the first six months of 2001, MGI PHARMA's revenues increased 49 percent to $18.6 million from $12.5 million in the corresponding 2000 period. Net loss in the first half of 2001 was $18.5 million, or a loss of $1.04 per share, compared to $9.0 million, or a loss of $0.58 per share in the corresponding 2000 period. As previously noted, the prior year's results have been restated for the effect of implementing Staff Accounting Bulletin 101 as of January 1, 2000 which resulted in a charge of $9.4 million, or $0.61 per share, in the first half of 2000. Total costs and expenses in the first half of 2001 increased 194 percent to $37.9 million from $12.9 million in the corresponding 2000 period. The increase in expenses is primarily due to increased research and development expenses relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the clinical and preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development of the Company's broad pipeline of oncology products, and the in-licensing of palonosetron, as well as the expansion of MGI's commercial capacity. In addition, as noted above, during the quarter the company incurred a license fee of $13.1 million related to the definitive agreement with Helsinn Healthcare SA, granting MGI PHARMA exclusive U.S. and Canadian license and distribution rights to the compound. At June 30, 2001 MGI PHARMA's assets totaled $67.3 million, including cash and investments of $42.7 million. Cash and investments include the 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 $29.2 million from the Company's sale of common stock during the second quarter. Second Quarter Developments Palonosetron Update Palonosetron is a potent, long-acting 5-HT3 receptor antagonist currently in Phase 3 development for the prevention of CINV. Second quarter highlights are as follows: Signed Definitive Agreement - as noted above, MGI PHARMA formally secured the definitive agreement with Helsinn Healthcare SA, granting the Company exclusive U.S. and Canadian license and distribution rights to palonosetron. Data Presented at ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company -- Results of two separate Phase 1 trials in healthy volunteers to assess the pharmacokinetic properties and safety of palonosetron were presented. Palonosetron was well tolerated and had no unexpected or serious side effects Side effects Effects of a proposed project on other parts of the firm. recorded in these Phase 1 trials. Palonosetron was also found to have a plasma elimination half-life of 37 hours, which is at least three times longer than other marketed agents in its class. Irofulven Update During the quarter, the Company made substantial progress in the clinical development program for irofulven, its lead anti-cancer compound. Highlights include the following: Fast Track Designation -- MGI PHARMA received Fast Track designation from the U.S. Food and Drug Administration for the use of irofulven in patients with Gemzar(R)-refractory 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. . Phase 3 Clinical Trial phase 3 clinical trial Phase 3 study. See Phase study. for Pancreatic Cancer -- Enrollment to date in the pivotal Phase 3 trial for the treatment of advanced pancreatic cancer is consistent with achieving the goal of full enrollment in third quarter of 2002. Additional Clinical Trials -- MGI initiated three new clinical trials with irofulven: -- Multi-center, Phase 2 trial in recurrent malignant glioma, the most common type of brain cancer, to evaluate irofulven as a single agent in up to 27 patients. -- Multi-center, Phase 2 trial in advanced or metastatic refractory soft tissue sarcoma, to evaluate irofulven in up to 40 patients. -- Phase 1 trial of irofulven in combination with Gemzar(R)in approximately 30 patients with advanced solid tumors. Data Presented at ASCO: -- Data were presented from a National Cancer Institute-sponsored Phase 2 trial of irofulven in 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 patients at this year's American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO) meeting held in San Francisco San Francisco (săn frănsĭs`kō), city (1990 pop. 723,959), coextensive with San Francisco co., W Calif., on the tip of a peninsula between the Pacific Ocean and San Francisco Bay, which are connected by the strait known as the Golden on May 12-15, 2001. Interim results were reported for 38 patients with recurrent disease following platinum and paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); treatments. Seven patients demonstrated objective responses; one patient had a complete clinical response, six patients had partial responses; and 13 had stable disease. Patients with partial responses remained progression-free for more than five and up to 20 months, and those with stable disease remained progression-free for two to nine months. -- Five abstracts were also published that included interim Phase 1 results for weekly dosing schedules of irofulven, as well as a summary of irofulven's anti-tumor activity across Phase 1 and 2 trials. The data showed that patients had greatly improved tolerance with weekly dosing schedules compared to previous trials with four or five consecutive days of treatment, while preserving anti-tumor activity. 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. Program During the quarter a key patent for "Inhibition of DNA Methyltransferase" was granted to MethylGene Inc., the partner with whom the Company has an exclusive North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. license and research and development agreement for inhibitors of DNA methyltransferase. As part of its existing agreement with MethylGene, MGI PHARMA has the exclusive license to develop, market and sell 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. 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). mRNA inhibitor inhibitor /in·hib·i·tor/ (in-hib´i-tor) 1. any substance that interferes with a chemical reaction, growth, or other biologic activity. 2. , and any small molecule inhibitor of DNA methyltransferase derived from the two companies' cancer research collaborations. This new patent, U.S. Patent No. 6,184,211, provides significant expansion of the intellectual property rights available under this exclusive agreement. Salagen(R) Presentation at ASCO The Radiation Therapy Oncology Group (RTOG RTOG Radiation Therapy Oncology Group RTOG Round Table of Goodness (diecast toy car collecting club) ) presented data from this 249-patient Phase 3 trial showing that concurrent use of Salagen(R) Tablets with radiation therapy gave a statistically significant improvement of salivary flow salivary flow, n the amount of saliva naturally produced by the salivary glands. Saliva production is increased by the presence of food or irritating substances, such as vomit, in the oral cavity. versus placebo in head and neck cancer patients. Based on these findings, RTOG concluded that this trial data provides new support for the use of Salagen Tablets during radiation treatment. Financing As noted above, in May the Company received net proceeds of approximately $29.2 million from the sale of four million 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. These proceeds add to the funds available for further development of the Company's broad portfolio of oncology products, and the shares were placed 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. . 2001 Financial Outlook This section provides forward-looking information about MGI PHARMA's financial outlook for 2001. These projections include the impact of MGI's entire product portfolio, which comprises Salagen(R) Tablets, Hexalen(R) Capsules, Mylocel(TM) Tablets, irofulven and the other acylfulvenes, palonosetron, MG98 and the complementary small molecule inhibitor program. 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 ending December 31, 2001: -- Product sales are currently projected to grow approximately 20 percent (a change from last quarter guidance), -- Cost of product sales as a percent of sales revenue is expected to range from 10 to 15 percent, -- Licensing revenue is expected to be approximately $3 million and would increase if 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. are out-licensed, -- R&D expense is expected to range from $35 to $45 million depending on the pace of irofulven and MG98 development and the timing of palonosetron milestone achievements, -- Selling, general and administrative expenses are expected to be approximately $25 million (a change from last quarter guidance), -- Amortization expense related to the acquisition of Hexalen Capsules is expected to be approximately $1.2 million, and -- Net loss is expected to range from $35 to $45 million. Webcast of Second Quarter Conference Call MGI PHARMA's 2001 second quarter conference call will be broadcast live over the Internet on Wednesday, July 18, 2001 at 1:00 p.m. Eastern Time. The Company's executive management team will review second quarter 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 the unmet needs of cancer patients. 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 forward-looking statements that may include statements regarding intent, belief or current expectations of the Company and its management. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that may cause the Company's actual results to differ materially from the results discussed in these statements. Factors that might affect MGI PHARMA's results include, but are not limited to the ability of MGI PHARMA's product candidates to be proven safe and effective in humans 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. MGI PHARMA does not intend to update any of the forward-looking statements after the date of this news release to conform them to actual results.
MGI PHARMA, INC.
Statements of Operations
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
----------------------- -------------------------
2000 2001 2000 2001
---------- ------------ ----------- ------------
Revenues:
Sales $6,134,082 $ 10,161,386 $10,700,377 $ 17,145,494
Promotion 269,874 0 519,874 0
Licensing 896,813 850,902 1,257,869 1,442,571
---------- ------------ ----------- ------------
7,300,769 11,012,288 12,478,120 18,588,065
---------- ------------ ----------- ------------
Costs and Expenses:
Cost of sales 393,142 1,031,483 697,213 1,820,836
Selling, general
& administrative 4,639,718 7,282,846 8,160,302 13,775,621
Research and
development 2,225,347 18,189,689 4,029,565 21,743,507
Amortization 0 295,495 0 590,989
---------- ------------ ----------- ------------
7,258,207 26,799,513 12,887,080 37,930,953
---------- ------------ ----------- ------------
Income (loss)
before interest
and taxes $ 42,562 $(15,787,225) $ (408,960) $(19,342,888)
Interest income 539,680 377,640 912,526 813,806
---------- ------------ ----------- ------------
Income (loss)
before taxes 582,242 (15,409,585) 503,566 (18,529,082)
---------- ------------ ----------- ------------
Provision for
income taxes 35,184 0 96,463 0
---------- ------------ ----------- ------------
Net income (loss)
before cumulative
effect of change
in accounting
principle $ 547,058 $(15,409,585) $ 407,103 $(18,529,082)
---------- ------------ ----------- ------------
Cumulative effect
of change in
accounting
principle $ 0 $ 0 $(9,402,643) $ 0
---------- ------------ ----------- ------------
Net income (loss) $ 547,058 $(15,409,585) $(8,995,540) $(18,529,082)
========== ============ =========== ============
Three Months Ended Six Months Ended
June 30, June 30,
---------------------- -----------------------
2000 2001 2000 2001
----------- ---------- ----------- ----------
Net income (loss) per common share:
Basic
Income (loss) from
continuing
operations $ 0.03 (0.81) $ 0.03 (1.04)
Cumulative effect of
accounting change 0.00 0.00 (0.61) 0.00
----------- ---------- ----------- ----------
Net income (loss) $ 0.03 (0.81) $ (0.58) (1.04)
=========== ========== =========== ==========
Assuming dilution
Income (loss) from
continuing
operations $ 0.03 (0.81) $ 0.03 (1.04)
Cumulative effect of
accounting change 0.00 0.00 (0.61) 0.00
----------- ---------- ----------- ----------
Net income (loss) $ 0.03 (0.81) $ (0.58) (1.04)
=========== ========== =========== ==========
Weighted average
number of common
shares:
Basic 15,812,118 18,987,549 15,514,659 17,766,891
Assuming dilution 17,160,856 18,987,549 15,514,659 17,766,891
Balance Sheet Data
(Unaudited)
December 31, June 30,
2000 2001
----------- -----------
Cash and short-term investments $29,898,787 $42,712,415
Total assets 52,743,570 67,276,816
Total stockholders' equity 26,045,617 41,047,936
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