Business Services Industry

IVAX Reports 3rd Quarter 2004 Results; Revenues up 22% to $439.1 Million; Net Income up 105% to $44.4 Million; EPS up 89% to $.17 -Pre-Split $.22-; 2004 Guidance Reconfirmed

Business Wire, Nov 1, 2004

MIAMI -- IVAX Corporation (AMEX: IVX, LSE: IVX.L) reported third quarter 2004 net revenues of $439.1 million and gross profit of $190.6 million, 22% and 19% increases, respectively, over net revenues of $360.6 million and gross profit of $160.5 million in the third quarter of 2003. Net income for the third quarter 2004 was $44.4 million, a 105% increase over net income of $21.6 million for the third quarter 2003. Third quarter 2004 earnings per share of $.17 (pre-split $.22) were 89% higher than $.09 in the third quarter of 2003. For nine months ending September 30, 2004, net revenues were $1.33 billion, and net income, $134.8 million, $.53 per share (pre-split $.66), compared to net revenues of $1.02 billion and net income, $91.9 million, $.37 per share in 2003. On August 24, 2004, IVAX concluded a five-for-four stock split and all financial data, except where indicated, have been adjusted accordingly.

Neil Flanzraich, vice chairman and president of IVAX Corporation said, "We are pleased at the continued growth of our business. This is the seventh consecutive quarter that IVAX has achieved year-over-year increases of net revenues and gross profit and the third consecutive quarter of year-over-year growth in net income. All our major business regions have generated continued revenue growth. In the third quarter 2004, our North American net revenues increased 24% from $172.3 million to $213.0 million. European net revenues increased 22% from $124.0 million to $151.2 million and Latin American net revenues increased 21% from $68.8 million to $83.2 million. This is the seventh consecutive quarter that our North American and European operations, and the sixth consecutive quarter that our Latin American operations, have achieved year-over-year quarterly net revenue growth.

"We also are pleased by the continued growth of IVAX' QVAR in the U.S. market. QVAR(R), the only CFC-free aerosol corticosteroid for asthma on the U.S. market, continues to gain market share which is up seven-fold since we first started selling QVAR in the U.S. in April 2002. IVAX' QVAR sales in Europe, started in the fourth quarter 2003, are also growing.

"IVAX continues to capitalize on a series of opportunities provided by our strong and increasing U.S. generic pipeline. It began with our six-month exclusivity launch of metformin ER in the U.S. in the fourth quarter 2003, followed in 2004 by our launch of Paxene(TM) in Europe as the first approved generic, and then our launch of glyburide/metformin HCl in the U.S, also with six-month exclusivity. On August 18, 2004, IVAX launched gabapentin tablets (100, 300 and 400 mg). Subsequently, three generic companies launched their gabapentin capsules (100, 300, and 400 mg). However, IVAX' product was the sole generic gabapentin on the market for nearly seven weeks. Patent litigation on gabapentin is pending. We expect that our strong U.S. generic pipeline will produce many such opportunities in the future.

"A number of factors reduced the expected benefits of some of these opportunities. After our exclusivity period on metformin ER expired, aggressive competitive pricing curtailed its revenue and earnings contributions. Aggressive pricing by an authorized generic distributor likewise affected revenues and profit from our sales of glyburide/metformin HCl. Furthermore, the introduction of three other generic marketers for gabapentin, markedly reduced prices after they launched their products. Also, profits in Europe were limited by generic pricing pressures and cyclical, weak summer sales.

"IVAX expects a good fourth quarter and year 2005, because of:

--Sales of our current line of U.S. generic products, which benefit from exclusivity periods for glyburide/metformin HCl and our gabapentin tablets.

--New generic approvals from our expanding generic pipeline, which now consists of 48 ANDAs pending with the FDA, of which ten are potentially first to be filed with current annual brand sales of over $12 billion in the U.S. One of these, fluticasone (a patent expiration), the generic equivalent of GlaxoSmithKline's Flonase(R), has annual U.S. sales of approximately $1 billion. This approval may come in 2004, and it can also be an important contributor to future revenues.

--First-to-file patent challenges of blockbuster drugs. We expect a decision before the end of the year on our patent challenge of Zyprexa(R), Eli Lilly's anti-psychotic drug with annual U.S. sales of $3 billion. IVAX strongly believes in all patent cases we initiate; naturally, however, no one can predict the outcome of any particular case. In May 2005, we start our patent challenge trial on Lexapro(R), Forest Labs anti-depressant drug with annual U.S. sales of $1.4 billion.

--Continued growth in QVAR sales in the U.S. and Europe.

--Last Friday evening's FDA approval of our NDA for HFA (CFC-free) albuterol in a metered dose inhaler (MDI), which was announced earlier today.

--Approval of our NDA for HFA (CFC-free) albuterol in our patented breath-activated device, expected in the first half of 2005. Both albuterol HFA products are expected to be important products, more so when CFC albuterol is removed from the U.S. market, now anticipated in 2006.

 

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