— SynagisTM Sales Reach $110 million for 1998 —
Gaithersburg, MD, January 27, 1999 -- MedImmune, Inc. (Nasdaq: MEDI) today reported that total revenues for the quarter ended December 31, 1998 increased 73 percent to $92.9 million from $53.8 million in the quarter ended December 31, 1997. Total revenues in fourth quarter 1998 included net product sales of $92.8 million for SynagisTM (palivizumab) and $9.2 million for CytoGam® (Cytomegalovirus Immune Globulin Intravenous (Human)). Total revenues were offset by $12.5 million for an estimate of potential returns of RespiGam® (Respiratory Syncytial Virus Immune Globulin Intravenous (Human)) which now is obsolete because of the launch of SynagisTM. Total revenues for the year ended December 31, 1998, including $109.7 million for sales of SynagisTM, increased 148 percent to $200.7 million from $81.0 million for the 1997 year.
Reported earnings for fourth quarter 1998 were $72.7 million or $1.13 per share on a diluted basis on 64.4 million shares compared with earnings in fourth quarter 1997 of $3.3 million or $0.06 per share on a diluted basis on 59.9 million shares. Reported earnings for the full year 1998 were $56.2 million or $0.91 per share on a diluted basis on 63.4 million shares compared with a loss in the full year 1997 of $36.9 million or $0.80 per share on a basic and diluted basis on 46.3 million shares. On December 31, 1998, cash and marketable securities were $134.9 million compared with $100.4 million on September 30, 1998 primarily reflecting positive cash flow from operations.
Results in fourth quarter 1998 included two adjustments: 1) a $47.4 million tax benefit reflecting the reversal of a valuation allowance for net operating loss and research and development tax credit carryforwards now expected to be realized and 2) the $12.5 million RespiGam® return estimate described above. Excluding these two items, earnings for fourth quarter 1998 would have been $37.7 million or $0.59 per share on a diluted basis, and for the 1998 year would have been $21.3 million or $0.37 per share on a diluted basis.
“The SynagisTM launch has exceeded even our own expectations and we believe we are well on our way to making this one of the most successful biotech product launches ever,” commented Wayne T. Hockmeyer, Ph.D., Chairman and Chief Executive Officer. “Our successes in 1998 go beyond SynagisTM and encompass all areas of the business. We continue to see growth in sales of our first product CytoGam®, we have made excellent progress in our R&D pipeline, we have maintained tight control over operating costs and we closed the year with the strongest balance sheet in the history of MedImmune. We are grateful to our employees, partners and shareholders for their contributions to our success and look forward to an outstanding 1999.”
For fourth quarter 1998, net sales of SynagisTM were $92.8 million compared with no SynagisTM sales in fourth quarter 1997 because SynagisTM was approved for marketing and launched in 1998. Sales of SynagisTM totaled $109.7 million since they commenced September 15, 1998. Net sales of CytoGam® in fourth quarter 1998 increased 43 percent to $9.2 million from $6.4 million in fourth quarter 1997 primarily reflecting strong international sales. Net sales of RespiGam®, which were $31.9 million in fourth quarter 1997, were negative $12.5 million in fourth quarter 1998 because of the estimate for returns reflecting obsolescence of RespiGam® following the introduction of SynagisTM. Other revenues decreased 82 percent to $2.7 million in fourth quarter 1998 from $15.4 million in fourth quarter 1997 primarily because of a $15.0 million payment in fourth quarter 1997 from Abbott Laboratories relating to the SynagisTM alliance, offset partly by R&D reimbursement from SmithKline Beecham (SB) in fourth quarter 1998 pursuant to the human papillomavirus vaccine alliance.
In fourth quarter 1998, gross margins improved to 71 percent from 46 percent in fourth quarter 1997. Excluding the effect of the estimate for RespiGam® returns, gross margins would have been 74 percent in fourth quarter 1998.
In fourth quarter 1998, sales, general and administration expenses increased to $31.6 million from $14.4 million in fourth quarter 1997. The increase, primarily related to the launch of SynagisTM, included increased selling and marketing expenses, as well as a co-promotion commission to Abbott accrued in accordance with the threshold-based co-promotion agreement between MedImmune and Abbott for sale of SynagisTM in the United States.
In fourth quarter 1998, other operating expenses decreased to $3.0 million from $7.8 million in fourth quarter 1997 primarily because of one-time payments to third parties in fourth quarter 1997 to provide additional production capacity for SynagisTM. Other operating expenses in fourth quarter 1998 are primarily related to manufacturing start-up costs associated with MedImmune's new manufacturing facility located in Frederick, Maryland.
SynagisTM is a humanized monoclonal antibody which was approved for marketing in June 1998 by the U.S. Food and Drug Administration (FDA) for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease (please see full prescribing information attached and at www.medimmune.com/products/synagispi.htm). SynagisTM is the first monoclonal antibody to be licensed for any infectious disease. SynagisTM is administered by intramuscular injection once per month during anticipated periods of RSV prevalence in the community. RSV is the most common cause of pneumonia and bronchiolitis in infants and children. In the Northern Hemisphere, the RSV season typically commences in November and lasts through April but it may begin earlier or persist later in certain communities.
CytoGam® is an intravenous immune globulin enriched in antibodies against cytomegalovirus (CMV) and is marketed by MedImmune in the United States for the prophylaxis against CMV disease associated with transplantation of kidney, lung, liver, pancreas, and heart (please see full prescribing information attached and at www.medimmune.com/products/cytopi1.htm).
RespiGam® is an intravenous immune globulin enriched in antibodies against RSV and is marketed by MedImmune in the United States for the prevention of serious lower respiratory tract infection caused by RSV in children under 24 months of age with BPD or a history of premature birth (i.e., less than or equal to 35 weeks gestation). RespiGam® was the first product demonstrated to be safe and effective in reducing the incidence and duration of RSV hospitalization and severity of RSV illness in these high-risk infants (please see full prescribing information attached and at www.medimmune.com/products/resppi.htm).
MedImmune, located in Gaithersburg, Maryland, is a biotechnology company focused on developing and marketing products for the prevention and treatment of infectious diseases and for use in transplantation medicine. MedImmune markets three products through its hospital-based sales force and has four new product candidates in clinical trials.
This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the Company's filings with the U.S. Securities and Exchange Commission. MedImmune cautions that RSV disease occurs primarily during the winter months; the Company believes its operating results will reflect that seasonality for the foreseeable future.
1998 Q4 Condensed Statement of Operations & Condensed Balance Sheet