MGI PHARMA REPORTS FIRST QTR '06 TOTAL REVENUE OF $78.2 MIL.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 NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :MOGN), an oncology- and acute care- focused biopharmaceutical company, Minneapolis, Minn., has reported total revenue for first quarter 2006 of $78.2 million. GAAP GAAP See: Generally Accepted Accounting Principles GAAP See generally accepted accounting principles (GAAP). net loss for the first quarter 2006 was $2.8 million, or $0.04 per diluted share. Pro forma As a matter of form or for the sake of form. Used to describe accounting, financial, and other statements or conclusions based upon assumed or anticipated facts. The phrase pro forma net loss for the first quarter of 2006 was $1.0 million, or $0.01 per diluted share, as is described below under "Reconciliation of GAAP to Pro Forma Net Income (Loss)." At March 31, 2006, MGI PHARMA's cash and marketable debt investments totaled $109.5 million. "We executed on several important initiatives during recent months that advance our portfolio of product candidates," said Lonnie Moulder moul·der v. Chiefly British Variant of molder. moulder or US molder Verb to crumble or cause to crumble, as through decay: , president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of MGI PHARMA. "The submission of the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any for Saforis and initiation of the Aquavan pivotal program were key milestones for MGI PHARMA that move us forward toward our objective of executing one product launch per year for the next three to four years. With the May 15 PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) date for Dacogen just weeks away, we are focused on our pre-launch activities in support of a potential product launch." First Quarter Results Total revenues for the first quarter of 2006 were $78.2 million compared to $63.2 million in the first quarter of 2005. Product sales increased to $77.5 million in the first quarter of 2006 from $62.4 million in the first quarter of 2005. During the first quarter of 2006, U.S. sales of Aloxi(R) (palonosetron hydrochloride palonosetron hydrochloride Aloxi Pharmacologic class: Selective serotonin subtype 3 (5-HT3) receptor antagonist Therapeutic class: Antiemetic Pregnancy risk category B ) Injection totaled $63.3 million compared to $57.2 million in the first quarter of 2005. Sales of Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) totaled $9.7 million for the first quarter of 2006 compared to $7.3 million for the first quarter of 2005, when this product was being marketed by Guilford Pharmaceuticals Inc.Total costs and expenses were $82.8 million in the first quarter of 2006 compared to $51.0 million in the first quarter of 2005. Selling, general and administrative expenses totaled $31.5 million in the first quarter of 2006 compared to $18.8 million in the same period in 2005, primarily due to the deployment and expansion of the acute care field organization, investment in the Aloxi brand, and increased administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. . Research and development expenses in the first quarter of 2006 were $23.0 million, compared to $10.3 million in the first quarter of 2005. The year-over-year increase in baseline R&D expenses is primarily due to expenses related to our late stage clinical development programs for Dacogen(TM) (decitabine) for Injection, Aquavan(R) (fospropofol disodium) Injection and amolimogene (HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) E6 E7 plasmid). The company reported a GAAP net loss of $2.8 million, or $0.04 per diluted share, in the 2006 first quarter compared to net income of $11.6 million, or $0.15 per diluted share, in the 2005 first quarter. As described below under "Reconciliation of GAAP to Pro Forma Income (Loss)," pro forma net loss for the 2006 first quarter was $1.0 million, or $0.01 per diluted share, compared to pro forma net income of $12.1 million, or $0.16 per diluted share, in the 2005 first quarter. Reconciliation of GAAP to Pro Forma Net Income (Loss): GAAP refers to generally accepted accounting principles The standard accounting rules, regulations, and procedures used by companies in maintaining their financial records. Generally accepted accounting principles (GAAP) provide companies and accountants with a consistent set of guidelines that cover both broad accounting in the U.S. MGI PHARMA's pro forma net income (loss) and earnings (loss) per diluted share exclude amortization of product acquisition intangible assets, acquired in-process research and development expenses, and license initiation and product candidate development milestone payments. We are reporting pro forma results in addition to, and not as a substitute for, financial measures calculated in accordance with GAAP. The company provides these pro forma numbers to facilitate a comparison of our business from period to period and to allow investors to analyze our business results. We encourage investors to carefully consider our results under GAAP, as well as our pro forma disclosures and the reconciliation between these presentations to more fully understand our business. Reconciliations between GAAP results and pro forma results are presented at the end of this news release. Recent Highlights -- The scale up of the acute care sales team to approximately 75 associates is now complete. This team has been trained and is actively promoting Aloxi within the hospital market. The company anticipates a three-fold increase in hospital-focused sales force activity in support of Aloxi and an impact on sales growth beginning in the second quarter of 2006. -- A direct-to-consumer advertising direct-to-consumer advertising Drug industry The use of mass media–eg, TV, magazines, newspapers, to publicly promote drugs, medical devices or other products which, by law, require a prescription, which targets consumers, with the intent of having a Pt initiative for Aloxi remains on track to begin during the second quarter with a print ad and Internet campaign. -- Launch preparations continue for Dacogen, which has a Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. (PDUFA) goal date of May 15, 2006. MGI PHARMA expects to be prepared to commercialize this product within several weeks of receiving 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. approval. -- A phase 3 pivotal trial of Dacogen in elderly patients with acute myeloid leukemia (AML AML - A Manufacturing Language ) began during the first quarter of 2006. This trial is part of a broad clinical development program for Dacogen, which is also being evaluated in a phase 2 study of elderly patients with AML, a phase 2 trial of an alternate dosing regimen in patients with myelodysplastic syndromes (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ), and a phase 3 EORTC-sponsored trial in patients with MDS. -- Following analysis of data from a phase 2 dose-ranging study of Aquavan(R) Injection, a dose was selected to advance into a pivotal program, which includes two pivotal trials and one safety study. Both pivotal trials are now underway, and enrollment in this program is expected to be complete by the end of 2006. -- The New Drug Application (NDA) for Saforis has been submitted to the U.S. FDA. Saforis is an investigational drug for the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy. One pivotal phase 3 trial and several supportive studies form the foundation of the Saforis NDA. 2006 Corporate Objectives & Milestones: This section and the "2006 Financial Outlook" section which follows it provide forward-looking information about MGI PHARMA's outlook for 2006 based upon our current operations. The disclosure notice paragraph regarding forward-looking statements at the end of this news release is especially applicable to these sections. In 2006, MGI PHARMA is focused on building upon the commercial and R&D progress made in 2005 by executing on key initiatives to advance our development pipeline and grow product sales. -- May 15, 2006 Dacogen PDUFA date -- Advance the Dacogen pivotal AML program -- Complete enrollment in the Dacogen ADOPT phase 2 MDS trial 3Q06 -- Complete enrollment in the Aquavan Injection pivotal program 4Q06 -- Complete 1st amolimogene (ZYC ZYC Zürcher Yacht Club (Switzerland) 101a) pivotal trial 4Q06 -- Complete Aloxi Injection PONV PONV Post-Operative Nausea and Vomiting pivotal program 4Q06 -- Complete Aloxi Capsule pivotal program 4Q06 -- Establish ex-U.S. commercialization paths for product candidates 2006 Pro Forma Financial Outlook For the year ending December 31, 2006, the company continues to expect the following: -- Total revenue to be in the range of $370 to $385 million, including the following: -- Aloxi Injection sales of $285 to $300 million; -- Gliadel Wafer sales of $40 million; and -- Dacogen injection sales of $25 million, if approved by the FDA during the second quarter; -- Gross profit to be in the range of $245 to $258 million, excluding $8 million of amortization of product acquisition intangible assets; -- SG&A expenses of $140 million; -- Net R&D expenses of $88 million, excluding product candidate development milestone payments of approximately $2 million and expenses incurred for Symphony Neuro Development company, a non-majority owned consolidated entity acquired in connection with the Guilford acquisition, a majority of which are reversed as minority interest prior to computing pre-tax income; and -- Pro forma operating income from operations to be in the range of $17 to $30 million. This guidance excludes the impact of FASB FASB See: Financial Accounting Standards Board FASB See Financial Accounting Standards Board (FASB). 123R, which is expected to be in the range of $8 to $10 million for the full year 2006. About MGI PHARMA MGI PHARMA, INC. is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) Injection and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. The company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information, visit http://www.mgipharma.com or call 212/332-4381. |
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