MGI PHARMA Reports 2002 First Quarter Results; Lonnie Moulder To Be Named President and Chief Operating Officer; Charles Blitzer To Be Named Chairman of the Board.Business Editors, Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--April 17, 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 total revenues decreased 23 percent to $5.8 million in the 2002 first quarter from $7.6 million in the first quarter a year ago. Total costs and expenses increased 12 percent to $12.4 million in the 2002 first quarter from $11.1 million in the 2001 first quarter. The Company reported a net loss of $6.3 million, or $0.25 per share, in the first quarter of 2002 compared to a net loss of $3.1 million, or $0.19 per share, in the first quarter of 2001. As noted in previous quarterly news releases, the surprisingly strong growth in sales of Salagen Salagen® ENT A pilocarpine used for dry mouth of Sjögren syndrome and RT for head & neck CA. See Pilocarpine. (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. ) during 2001 included growth of underlying patient demand, an increase in unit prices and an increase in the quantity of inventory within distribution channels, especially at wholesale distributors. In the first quarter of 2002, our sales of Salagen Tablets declined 21 percent, or $1.2 million, compared to the first quarter of 2001. This occurred because wholesaler inventory quantities were being reduced, even though patient prescription growth continued. The increase in costs and expenses was primarily due to increased drug development activity. Executive Management Update The MGI PHARMA board of directors intends to appoint Lonnie Moulder moul·der v. Chiefly British Variant of molder. moulder or US molder Verb to crumble or cause to crumble, as through decay: , 44, to the position of president and chief operating officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of the Company at its May 14, 2002 board meeting. Mr. Moulder has served as executive vice president of MGI since September 1999, and has more than 20 years of pharmaceutical industry experience. Mr. Moulder previously held a number of positions with Hoechst Marion Roussel, now Aventis Pharma, and its predecessor companies, Marion Laboratories and Marion Merrell Dow (Direct OverWrite) See magneto-optic disk. Pharmaceuticals, where he was pivotal in the establishment of an 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. franchise. In his new role, his responsibilities will include managing company operations and advancing strategies for the growth of MGI. Charles Blitzer, 61, will remain chief executive officer of the corporation, and will also be appointed chairman of the board of directors. These executive promotions will take effect upon board resolution on May 14. "We are pleased about the near-term appointment of Lonnie Moulder as our president and chief operating officer this May," said Chuck Blitzer, president and chief executive officer of MGI since 1996. "Lonnie's leadership has been instrumental during the last two years in advancing our Company's strategies and expanding MGI's commercial presence in the oncology market. Lonnie's strong experience, energy and executive leadership will now help take our Company to its next exciting level as we transition even more into a commercially-oriented entity." "We are also grateful for the leadership of Hugh Miller Hugh Miller (1802 – 1856) was a self-taught Scottish geologist and writer and an evangelical Christian. Born in Cromarty, he had an ordinary parish school education, but soon showed a remarkable love of reading and power of story-telling. , who has served as our board chairman for nearly four years," said Mr. Blitzer. "We are equally pleased that Hugh will be remaining as a director on our board and that we will continue to benefit from his many contributions." Recent Company Highlights Palonosetron Update Palonosetron is a potent, highly selective 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 with an extended half-life, in late-stage 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 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 ). Recent highlights include: -- 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 and selling, general and administrative expenses to be less than $65 million,(1) -- Amortization expense related to the acquisition of Hexalen capsules to be approximately $1.2 million, -- Net loss to be approximately $35 million,(1) and -- Cash use of approximately $30 million.(1) Irofulven Update Irofulven, MGI's novel compound with a unique mechanism of action and demonstrated activity in a variety of cancers, is the first product candidate being developed by the Company from its family of proprietary anti-cancer compounds called acylfulvenes. First quarter activities include the following: -- 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 and selling, general and administrative expenses to be less than $65 million,(1) -- Amortization expense related to the acquisition of Hexalen capsules to be approximately $1.2 million, -- Net loss to be approximately $35 million,(1) and -- Cash use of approximately $30 million.(1) 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, 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). , 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. -- 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 and selling, general and administrative expenses to be less than $65 million,(1) -- Amortization expense related to the acquisition of Hexalen capsules to be approximately $1.2 million, -- Net loss to be approximately $35 million,(1) and -- Cash use of approximately $30 million.(1) 2002 Financial Outlook This section provides forward-looking information about MGI PHARMA's financial outlook 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 and selling, general and administrative expenses to be less than $65 million,(1) -- Amortization expense related to the acquisition of Hexalen capsules to be approximately $1.2 million, -- Net loss to be approximately $35 million,(1) and -- Cash use of approximately $30 million.(1) (1) Reductions from prior guidance. Updated Conference Call & Webcast Information MGI PHARMA will broadcast its quarterly investor conference call live over the Internet today, Wednesday, April 17, 2002 at 9:00 a.m. Eastern Time. The Company's executive management team will review first quarter 2002 financial results, discuss preliminary analysis of the palonosetron Phase 3 trial results, discuss the irofulven Phase 3 trial announcement, answer questions from analysts and investors, and provide commentary on MGI's product portfolio and 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. This conference call was re-scheduled from Wednesday afternoon to this earlier 9:00 a.m. morning time. About MGI PHARMA MGI PHARMA, Inc. is an oncology-focused pharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet un·met adj. Not satisfied or fulfilled: unmet demands. 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 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. 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, such as palonosetron and irofulven, to be proven safe and effective in humans, to receive marketing authorization The right or permission to use a system resource; the process of granting access. See access control. 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 March 31,
2001 2002
----------------------------
Revenues:
Sales $6,984,108 $5,302,773
Licensing 591,669 499,099
------------ ------------
7,575,777 5,801,872
------------ ------------
Costs and Expenses:
Cost of sales 789,353 685,829
Selling, general and
administrative 6,492,775 7,170,326
Research and development 3,553,818 4,262,662
Amortization 295,494 295,495
------------ ------------
11,131,440 12,414,312
------------ ------------
Loss before interest (3,555,663) (6,612,440)
Interest income 436,166 319,870
------------ ------------
Net loss $(3,119,497) $(6,292,570)
============ ============
Net loss per common share:
Basic $ (0.19) $ (0.25)
Assuming Dilution $ (0.19) $ (0.25)
Weighted average number
of common shares:
Basic 16,532,670 25,033,952
Assuming dilution 16,532,670 25,033,952
Balance Sheet Data
(Unaudited)
December 31, March 31,
2001 2002
---------------------------
Cash and marketable
investments $77,712,480 $69,022,365
Total assets 97,668,023 89,984,148
Total stockholders' equity 68,934,711 63,289,606
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