Aloxi takes the number one spot in injectable CINV:
Press Release Source: MGI PHARMA, INC.
MGI PHARMA Reports First Quarter Results
Wednesday April 13, 4:01 pm ET
MINNEAPOLIS--(BUSINESS WIRE)--April 13, 2005--MGI PHARMA, INC. (NASDAQ:MOGN - News):
* 135% Increase in Total Revenue Over Prior Year
* Aloxi® Injection Achieves #1 Share Position in Injectable CINV Market
* Q1 2005 Aloxi® Sales Increase 207% From Q1 2004, Total $57.2 Million
* Saforis(TM) New Drug Application (NDA) Timeline Accelerated
* SPA Completed for Aloxi® Injection in PONV and Aloxi Oral Formulation
* Dacogen(TM) Registration Program in Acute Myeloid Leukemia (AML) Initiated
MGI PHARMA, INC. (NASDAQ:MOGN - News), an oncology-focused biopharmaceutical company, today announced that total revenue for the first quarter of 2005 was $63.2 million, including Aloxi® (palonosetron hydrochloride) injection sales of $57.2 million. GAAP net income for the first quarter of 2005 was $11.6 million, or $0.15 per diluted share. At March 31, 2005, MGI PHARMA's unrestricted cash and marketable debt investments totaled $212.6 million.
"During the first quarter of 2005, MGI PHARMA made significant progress on many fronts," said Lonnie Moulder, president and chief executive officer. "Aloxi injection continues to gain share from its competitors in the chemotherapy-induced nausea and vomiting (CINV) market, and in its 18th month of promotion, Aloxi injection reached the number one market share position among intravenous 5-HT3 receptor antagonists used for the prevention of CINV. We are also very pleased with the progress made with respect to our late-stage pipeline. We now plan to submit an NDA for Saforis oral suspension during the third quarter, and our registration program for Dacogen injection in AML is underway."
First Quarter 2005 Financial Results
Sales increased to $62.4 million in the first quarter of 2005 from $25.8 million in the first quarter of 2004, primarily due to increased sales of Aloxi injection. During the first quarter of 2005, U.S. sales of Aloxi injection totaled $57.2 million, compared to $18.6 million in the first quarter of 2004. Total revenues for the first quarter of 2005 were $63.2 million compared to $26.9 million in the first quarter of 2004.
Total costs and expenses increased to $51.0 million in the first quarter of 2005 from $30.1 million in the first quarter of 2004. Selling, general and administrative expenses increased to $18.8 million for the first quarter of 2005 from $17.5 million for the same period in 2004. Research and development expenses in the first quarter of 2005 were $10.3 million, compared to $5.0 million in the first quarter of 2004. This year-over-year increase in R&D expenses is due to development programs for the late-stage product candidates in our pipeline, including those acquired in 2004.
The Company reported GAAP net income of $11.6 million, or $0.15 per diluted share, in the 2005 first quarter compared to a net loss of $3.1 million, or $0.05 per diluted share, in the 2004 first quarter. Pro forma net income for the 2005 first quarter was $8.1 million, or $0.11 per diluted share, compared to a pro forma net loss of $1.5 million, or $0.02 per diluted share, in the 2004 first quarter.
Note: GAAP refers to U.S. generally accepted accounting principles. MGI PHARMA's pro forma earnings per diluted share and pro forma net income exclude amortization of product acquisition intangible assets, acquired in-process research and development expenses, license initiation and product candidate development milestone payments and revenue resulting from a terminated license agreement, and reflects an effective tax rate of 35% as if the Company were subject to a standard tax provision. 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 allow investors to analyze our business results as if we were currently subject to a standard tax rate. 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
Aloxi® Injection
* The Special Protocol Assessment (SPA) process with the United States Food and Drug Administration (FDA) has been completed for the Aloxi injection for post operative nausea and vomiting (PONV) and Aloxi oral formulation phase 3 programs.
* The phase 3 program for Aloxi injection for the prevention of PONV is expected to begin within the next several weeks. Two studies are planned to enroll over 1,000 patients across 4 treatment arms. Patients will be randomized to receive either placebo or one of three dose levels of Aloxi injection. The co-primary efficacy endpoint for both trials is complete response (defined as no emetic episode and no rescue medication) during the first 24 hours after surgery and for the 24-72 hour postoperative time period.
Dacogen(TM) Injection
* The registration program for Dacogen (decitabine) injection in AML has been initiated, and a multicenter phase 2 trial of Dacogen injection as a front line therapy for AML patients is now underway. This trial is designed to enroll 54 patients aged 60 years or older with AML. Patients will receive Dacogen injection at a dose of 20 mg/m2 administered as a 1 hour intravenous infusion once per day for 5 days, repeated every 4 weeks. The primary endpoint of this study is complete remission rate. The SPA process is underway for a phase 3 trial of Dacogen injection in elderly AML patients.
* Five abstracts describing Dacogen injection will be presented or published at the American Society of Clinical Oncology (ASCO) annual meeting (May 13-17, 2005). In addition, a symposium held in conjunction with ASCO titled Breakthroughs in Therapeutic Epigenetics: An Emerging Clinical Approach chaired by Dr. Hagop Kantarjian, Professor & Chairman at The University of Texas M. D. Anderson Cancer Center, will be held on Friday, May 13, 2005.
Saforis(TM) Oral Suspension
# MGI PHARMA plans to submit an NDA for Saforis oral suspension based on the successfully-completed phase 3 trial by the end of the third quarter of 2005. A second phase 3 trial of Saforis oral suspension is now expected to begin shortly after the NDA submission is complete. This trial is being planned to further expand the potential applications of the product.
Other Highlights
# Jim Hawley assumed MGI PHARMA's chief financial officer role upon filing of the Company's 2004 Form 10-K with the Securities and Exchange Commission.
2005 Corporate Objectives:
In 2005, MGI PHARMA remains focused on maximizing the commercial potential of Aloxi injection in CINV, as well as advancing our clinical programs and executing our overall corporate strategy. The Company is focused on the following corporate objectives for 2005:
Revenue:
* Achieve U.S. sales of Aloxi injection of $260 million
* Achieve other product sales, promotion revenue and licensing revenue totaling $25 million
Product candidates:
* Expand the development program for Dacogen injection beyond the pending myelodysplastic syndrome (MDS) indication by initiating a pivotal phase 3 program in patients with AML
* Advance the phase 3 programs for Aloxi injection in PONV and for an oral Aloxi formulation
* Complete the NDA submission for Saforis oral suspension during the third quarter of 2005 and initiate a phase 3 trial of Saforis oral suspension in patients with oral mucositis shortly after the NDA is completed
* Advance ZYC101a into a pivotal program in patients with cervical dysplasia in mid-2005
* Complete a phase 2 trial of irofulven in patients with taxane/hormone-refractory prostate cancer
* Advance the ZYC300 clinical development program in patients with solid tumors
Other corporate goals:
* Achieve full-year profitability in 2005
* Complete pre-launch preparations for Dacogen injection
* Establish commercialization paths for our products in territories outside of North America.
Financial Outlook for 2005:
This section provides forward-looking information about MGI PHARMA's financial outlook for 2005 based upon our current operations. The disclosure notice paragraph regarding forward-looking statements at the end of this news release is especially applicable to this section.
Consistent with the Company's past practices for providing product candidate guidance when they are undergoing FDA review, this guidance excludes any revenue contribution from Dacogen injection, but includes all Dacogen-related expenses through initial market launch. The effect of the scheduled implementation of FASB Statement No. 123 (Revised 2004), Share-Based Payment, has not been included in the following guidance.
For the year ending December 31, 2005, we continue to expect:
* Total revenue of approximately $285 million, including:
* Aloxi injection product sales of approximately $260 million;
* Other product sales, licensing and promotion revenue of $25 million;
* Cost of product sales of approximately $97 million;
* SG&A expenses of approximately $80 million;
* Net R&D expenses of approximately $46 million;
* Income from operations of approximately $62 million;
* Approximately 76 million fully diluted shares prior to inclusion of shares that would issue upon conversion of our debt; and
* An effective tax rate of approximately 3%.
Approximately 8.3 million shares will be issued upon full conversion of our convertible debt. Those shares will be considered in MGI PHARMA's diluted share count when they are deemed to be dilutive by accounting standards.
Conference Call & Webcast Information
MGI PHARMA will broadcast its quarterly investor conference call live over the Internet today, Wednesday, April 13, 2005 at 5:00 p.m. Eastern Time. The Company's executive management team will review 2005 first quarter financial results, discuss operations, and provide guidance on MGI PHARMA's 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. |
