Well, I was very much hoping to get a meaningful update of the MGI-114 trials. No such luck...
RB
Wednesday July 21, 6:59 am Eastern Time
Company Press Release
SOURCE: MGI Pharma, Inc.
MGI PHARMA Revenues Grow Nearly Fifty Percent in the 1999 Second Quarter and First Half
Earnings Reach $1.3 Million in First Half of 1999
MINNEAPOLIS, July 21 /PRNewswire/ -- MGI PHARMA, INC. (Nasdaq: MOGN - news), a pharmaceutical company, today reported a 46-percent increase in revenues (which include product sales, promotion, licensing and interest income) to $6.3 million in the 1999 second quarter from $4.3 million in the 1998 second quarter. Net earnings for the 1999 second quarter totaled $611,190, or four cents per diluted share, compared to a net loss of $70,875, or zero cents per share, for the year-ago quarter.
All revenue categories produced increases in the 1999 second quarter. Product sales grew 46 percent, fueled by a 56-percent increase in U.S. sales of Salagen® tablets (pilocarpine hydrochloride). Product sales totaled $4.8 million for the quarter, up from $3.3 million in 1998, while U.S. sales of Salagen tablets totaled $4.6 million in the second quarter, compared to $3.0 million in second quarter of 1998. Licensing income increased 50 percent in the 1999 second quarter due primarily to higher royalties, and promotion income increased 100 percent reflecting the impact of the new relationship with Connetics Corporation (Nasdaq: CNCT - news) announced at the end of the 1999 first quarter. Interest and other income also improved slightly, reflecting the company's improving cash flow.
For the first six months of 1999, MGI PHARMA's revenues increased 48 percent to $12.0 million from $8.1 million in 1998. Net earnings for the 1999 six-month period were $1.3 million, or eight cents per diluted share, compared to a net loss of $167,922, or one cent per share, for the same period in 1998.
Revenue increases in the first half of 1999 were driven primarily by a 57-percent increase in product sales and a 45-percent increase in licensing income. Product sales for the first six months of 1999 totaled $9.3 million, including $8.9 million of U.S. sales of Salagen tablets, comparing favorably to the first six months of 1998 when product sales totaled $5.9 million and U.S. sales of Salagen tablets totaled $5.5 million. Licensing income for the first half of 1999 totaled $1.9 million, compared to $1.3 million reported in the 1998 first half.
MGI PHARMA's cash and investment position at the end of the 1999 second quarter was $17.9 million, with total assets of $22.8 million. The company has no long-term debt.
Charles N. Blitzer, MGI's president and chief executive officer, said, ''The last several quarters have been an exciting time for MGI PHARMA. We continue to deliver strong revenue gains and are maintaining our profitability, which we intend to leverage for future growth opportunities. Our most recent promotional relationships with Connetics and Pharmacia & Upjohn (NYSE: PNU - news) for three rheumatology products should help us maintain momentum as we add more critical mass to our base business.''
Update on MGI 114
During the 1999 second quarter, MGI PHARMA continued to advance the development of MGI 114, a promising anti-cancer drug. MGI PHARMA is sponsoring three Phase 2 human clinical studies (one each in pancreatic, ovarian and prostate cancer) and the National Cancer Institute (NCI) has several additional Phase 2 trials under way. All of these studies are actively enrolling and treating patients. In May, MGI PHARMA expanded its ovarian cancer study with MGI 114 after a 67-percent reduction in tumor mass was confirmed in one patient. This followed the December 1998 expansion of MGI PHARMA's prostate study after meeting the pre-established requirements for demonstration of anti-cancer activity. In May, additional data from the prostate study was presented at the American Society of Clinical Oncology (ASCO) annual meeting that showed further evidence of anti-tumor activity, including the reduction of soft tissue disease in two patients.
Commenting on MGI 114, Blitzer stated: ''We remain pleased with the progress of MGI 114 and excited about its future potential to treat a variety of cancers. We are moving as aggressively as possible with our clinical development efforts on this agent, and continuing preclinical evaluation of related analogs from the broader family of acylfulvenes.''
In addition to the Phase 2 studies, there are three Phase 1 human studies currently underway with MGI 114. The NCI is actively treating pediatric cancer patients and adult leukemia patients in Phase 1 safety studies, and MGI PHARMA is conducting a combination Phase 1 human safety study with Camptosar® (irinotecan), an approved cancer drug for colon and rectal cancers.
MGI PHARMA is a pharmaceutical company that acquires, develops and markets differentiated specialty pharmaceutical and medical products for therapeutic markets of unmet needs. MGI PHARMA's current product portfolio is comprised of products that address specific needs in the fields of cancer and rheumatology. The company plans to expand its scope as the business grows. MGI PHARMA focuses its efforts solely in the United States and creates partnerships with other pharmaceutical or biotechnology companies for its products in international markets.
This press 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 cause such differences include, but are not limited to the continued growth in sales of Salagen® Tablets, the successful advancement of MGI 114 in clinical trials, the uncertainty of strategic alliances, the development or acquisition of additional products, and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission.
MGI PHARMA, INC.
STATEMENTS OF OPERATIONS (Unaudited) Three Months Ended Six Months Ended June 30, June 30, 1999 1998 1999 1998
Revenues: Sales $4,754,179 $3,260,293 $9,257,122 $5,889,245 Promotion 250,000 125,000 375,000 500,000 Licensing 1,037,067 693,610 1,908,783 1,314,770 Interest and other 210,766 200,498 405,289 387,143 6,252,012 4,279,401 11,946,194 8,091,158
Costs and Expenses: Cost of sales 254,681 293,364 562,559 500,505 Selling, general and administrative 3,569,703 2,649,550 6,743,199 5,063,805 Research and development 1,746,720 1,357,362 3,207,625 2,594,770 5,571,104 4,300,276 10,513,383 8,159,080
Income (loss) before taxes 680,908 (20,875) 1,432,811 (67,922)
Provision for income taxes 69,718 50,000 138,656 100,000
Net income (loss) $611,190 $(70,875) $1,294,155 $(167,922)
Net income (loss) per common share: Basic $0.04 $(0.00) $0.09 $(0.01)
Assuming dilution $0.04 $(0.00) $ 0.08 $(0.01)
Weighted average number of common shares outstanding: Basic 14,647,411 14,325,735 14,611,370 14,268,708
Assuming dilution 15,549,121 14,325,735 15,512,507 14,268,708
Balance Sheet Data (Unaudited) June 30, December 31, 1999 1998
Cash and investments $17,949,601 $17,081,265 Total assets 22,837,595 21,122,068 Total stockholders' equity 19,579,935 17,110,668
SOURCE: MGI Pharma, Inc. |