MedImmune Inc. and Serono SA both reported upticks in revenue and earnings per share in their third-quarter financial statements.
On a GAAP (generally accepted accounting principles) basis, MedImmune recorded a $16 million net loss, or 7 cents per share, narrower figures than last year's third-quarter net loss of $36 million, or 14 cents per share. On an adjusted based, which excludes the acquisition of the Gaithersburg, Md.-based company's vaccine unit, MedImmune reported a $16 million net loss, or 6 cents per share. Last year's adjusted net loss from the corresponding quarter totaled $32 million, or 13 cents per share.
The adjusted loss topped analysts' estimates of 8 cents per share.
MedImmune's three-month revenues climbed to $99 million, a 34 percent gain over $74 million. The company attributed the gain to $82 million in product sales, a figure bolstered by a 55 percent increase in Synagis (palivizumab) sales to $49 million. The remaining $17 million in revenue was mostly due to milestone and other payments for FluMist (influenza virus vaccine live, intranasal), a product approved in June and launched last month with Wyeth, of Madison, N.J.
"The third quarter of 2003 was a very busy one for us here at MedImmune," CEO David Mott said during a conference call. "Not only did we launch FluMist, our intranasally delivered flu vaccine, but we did so while also making major progress in nearly every other part of our business."
MedImmune closed the quarter with $1.7 billion in cash and marketable securities, as well as 249.4 million shares outstanding.
Going forward, the company offered fourth-quarter earnings-per-share guidance of 42 cents to 47 cents on a GAAP basis, or 44 cents to 49 cents on an adjusted basis. MedImmune also forecast fourth-quarter revenues to range from $450 million to $500 million.
For the full year, the company projected earnings per share of 84 cents to 89 cents on a GAAP basis, compared to a net loss of $4.40 per share last year. On an adjusted basis, MedImmune expects earnings per share to range between 88 cents to 93 cents. And clearly, the company is banking on sales growth of FluMist, which it acknowledged could start slower than planned as a result of its later-than-expected approval and a decision by Wal-Mart not to stock the vaccine.
"While we have gotten off to a slower-than-expected start," Mott said, "we continue to be cautiously optimistic and have the vast majority of the flu immunization season ahead of us. We have reconfirmed our prior guidance of $120 million to $140 million in total revenues to MedImmune from FluMist this year."
Third-quarter drug development highlights include clinical data that could be used to expand FluMist's label to add patients under 5 years of age or older than 50, based on positive Phase II and Phase III findings on CAIV-T, a refrigerator-stable liquid formulation of FluMist being developed with Wyeth.
During the quarter, MedImmune also pushed Vitaxin into two of a possible four Phase II studies. The first is testing the drug in 110 melanoma patients, while the second evaluates Vitaxin in rheumatoid arthritis patients. On Sept. 30, the company filed an investigational new drug application for Numax, a second-generation compound of Synagis.
MedImmune's stock (NASDAQ:MEDI) lost 45 cents Thursday to close at $28.45.
Serono Reports Best Quarter Ever'
Geneva-based Serono's quarterly earnings continued on a positive path.
The company reported net income of $110.5 million for the quarter, a 48 percent gain over last year. The profitable figure included basic earnings per share of 17 cents for each American Depository Share and $6.98 per bearer share, a 49 percent increase.
"This has been a great quarter," CEO Ernesto Bertarelli said during a conference call. "In fact, it has been our best quarter ever."
Growing revenues supported the earnings, with Serono recording a 33 percent surge to $502.7 million, as did favorable currency effects of a weak U.S. dollar. A corresponding 33 percent increase in product sales to $463.5 million reinforced the revenue figures.
"We have delivered significant product sales growth in the third quarter in each of our therapeutic areas," Bertarelli said, "as well as in each of our geographic regions."
Total North American sales produced $180 million, a 52 percent rise. European sales grew about 26 percent to $192 million, while sales in the rest of the world reached $92 million, a 17 percent gain.
Among its neurology products, sales of Rebif (interferon beta-1a) generated $212 million worldwide, reflecting 52 percent growth from a year before and representing 95 percent of Serono's total neurology sales. Bertarelli said the product remains the world's leading multiple sclerosis drug outside the U.S., where it brought in $162 million. Rebif competes with Avonex (interferon beta-1a), from Cambridge, Mass.-based Biogen Inc.; Betaferon/Betaseron (interferon beta-1b), from Montville, N.J.-based Berlex Laboratories Inc. and Emeryville, Calif.-based Chiron Corp.; and Copaxone (glatiramer acetate), from Jerusalem-based Teva Pharmaceutical Industries Ltd.
Purchases of Gonal-f (follitropin alfa for injection), its lead reproductive health offering, grew by 12 percent to $117.1 million. Sales of Saizen (somatropin [rDNA origin] for injection), a growth hormone product, climbed 27 percent to $36.8 million.
Serono also pointed to research and development highlights during the quarter, in which it advanced two more candidates into clinical studies - cladribine, being developed as an oral multiple sclerosis therapy, and TACI-Ig, a fusion protein inhibitor of B-cell activation being developed for autoimmune diseases such as lupus and rheumatoid arthritis, as well as non-Hodgkin's lymphoma.
Serono closed the quarter with 15.8 million bearer shares outstanding, as well as reserves of $661.9 million in cash and cash equivalents.
Its stock (NYSE:SRA) gained 4 cents to close at $17.08.