Noven Announces First Quarter 2001 Financial Results

Pre-Tax Income Increases 126%

Vivelle Family Market Share Increases to Nearly 30%

-- Noven Pharmaceuticals, Inc. (Nasdaq:NOVN) today announced financial results for the quarter ended March 31, 2001.

Noven reported net income of $2.7 million ($.11 diluted earnings per share) for the first quarter of 2001, compared to $1.8 million ($.08 diluted earnings per share) for the first quarter of 2000. Income before income taxes for the 2001 first quarter was $4.2 million, compared to $1.9 million for the first quarter of last year. Revenues for the 2001 first quarter were $12.7 million, compared to $9.6 million for the same quarter in 2000. Noven recorded $1.5 million in taxes in the first quarter of 2001, compared to $35,000 in the first quarter of last year.

Novogyne Pharmaceuticals, Noven's women's health products company owned jointly with Novartis Pharmaceuticals Corporation, produced sufficient income in the first quarter of 2001 to satisfy Novartis' $6.1 million preferred return for the year and for Noven to recognize $0.6 million in earnings from Novogyne. In the first quarter of 2000, Noven recognized $0.5 million in earnings from Novogyne.

As of March 31, 2001, Noven had cash and cash equivalents of $46.2 million, compared to $41.0 million as of December 31, 2000.

"With a 126% increase in pre-tax income and several strategic advancements during the first quarter, Noven is off to a good start in 2001,'" said Robert C. Strauss, Noven's President, CEO and Co-Chairman. "In the U.S., Vivelle® family prescriptions continue to increase. As of the end of the first quarter, the Vivelle family's share of the U.S. transdermal estrogen market had increased to nearly 30%. In late March, we added CombiPatch™ to the Novogyne portfolio, making Novogyne the only company in the country to offer patch products for both the estrogen-only and combination hormone therapy markets. This should help continue Novogyne's market share momentum. As long as prescriptions continue to grow, we know that sales will follow. In fact, preliminary sales reports for April suggest that Novogyne is completing the best sales month in its history, even excluding CombiPatch sales.

"Also during the first quarter, Estradot™ received its first European approval. Novartis is now expected to advance the Mutual Recognition Procedure process to get the product broadly approved in Europe. Novartis' license of Estradot, combined with their previous license of Estalis® and their recent acquisition of rights to future versions of the combination patch, give us great confidence that Novartis is committed to Noven's products and technologies. This should bode well for the long-term growth of Noven's hormone replacement therapy business.

"Not all first quarter news was favorable; we announced that Phase III study results for our methylphenidate patch, unblinded in late March, were inconclusive. Since then, we have identified issues with the study design, not with the product itself. In fact, among patients manifesting significant ADHD symptoms, our product demonstrated efficacy with statistical significance. At a constructive meeting held in the latter half of April, we found the Food & Drug Administration to be supportive of our plan to proceed with an additional clinical study with a revised protocol. We look forward to finalizing our protocol, completing the study, submitting our NDA in the first half of 2002, and ultimately making an important contribution to the world of ADHD therapy."

Analyst Conference Call
A telephone conference among management and equity analysts relating to Noven's financial results will be broadcast live via the Internet at beginning at 5:00 p.m. Eastern time this afternoon, April 30. Thereafter, a rebroadcast of the call will be accessible at the same website. For those without Internet access, a taped replay of the conference call will be available by telephone from April 30 at 9:00 p.m. Eastern time until the evening of May 2 by calling 800-475-6701 (from within the U.S.) or 320-365-3844 (from outside the U.S.) and entering the access code 584092.

                      Noven Pharmaceuticals, Inc.

Statements of Operations Data:                  Three Months Ended
(amounts in thousands, except                        March 31,
per share amounts)                             2001          2000
                                               ----          ----
                                           (Unaudited)    (Unaudited)
     Product sales                          $ 12,022       $  9,456
     License revenue                             667            147
                                             -------        -------
     Total revenues                           12,689          9,603

     Cost of products sold                     4,816          4,511
     Research and development                  2,227          1,825
     Marketing, general and administrative     2,660          2,082
                                             -------        -------
     Total  expenses                           9,703          8,418
                                             -------        -------
    Income from operations                     2,986          1,185

Equity in earnings of Novogyne                   595            477
Interest income, net                             619            200
                                             -------        -------
Income before income taxes                     4,200          1,862

Provision for income taxes                     1,533             35
                                             -------        -------
Net income                                  $  2,667       $  1,827
                                             =======        =======
Basic earnings per share                    $   0.12       $   0.08
                                             =======        =======
Diluted earnings per share                  $   0.11       $   0.08
                                             =======        =======

Weighted average number of common
   shares outstanding:
           Basic                              22,236         21,682
                                             =======        =======
           Diluted                            23,606         22,827
                                             =======        =======

                                                     As Of
                                            March 31,    December 31,
Balance Sheet Data:                           2001           2000
                                              ----           ----

  Cash and cash equivalents                 $ 46,235       $ 40,976

  Working capital                           $ 50,978       $ 46,734

  Investment in Novogyne                    $ 18,076       $ 15,431

  Total assets                              $149,923       $104,031

  Deferred license revenue                  $ 30,053       $ 27,220

  Stockholders' equity                      $ 69,534       $ 65,277

About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leader in the development of transdermal and transmucosal drug delivery technologies and products. Together with Novartis Pharmaceuticals, Noven owns a women's health products company called Novogyne Pharmaceuticals. Noven's existing products include advanced estrogen transdermal delivery systems (including Vivelle-Dot™, licensed to Novogyne, and Estradot, licensed to Novartis) and combination estrogen/progestin transdermal delivery systems (including CombiPatch, licensed to Novogyne, and Estalis, licensed to Novartis). With a range of additional products in development, Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal and transmucosal drug delivery systems.

For additional information on Noven, visit the company's web site at For information on Noven's Vivelle and Vivelle-Dot products, visit

Forward looking statements contained in this release are qualified by and subject to the risks and uncertainties specified in Noven'smost recent filings with the Securities and Exchange Commission, including the risk that results for future periods may be less than anticipated because of, among other factors, competitive market conditions affecting Noven's hormone replacement patches and other products, the inability to develop new products, delays in the launch of Estalis by Novartis in certain countries, delays in the launch of Estradot abroad due to the failure to receive regulatory approvals or other factors, the failure of MethyPatch® clinical studies, delays in filing a MethyPatch New Drug Application, and the inability of Noven to receive FDA approval to market MethyPatch or its developmental HRT patches and/or to successfully commercialize such products.

Investor & Media Contact:
Joseph C. Jones
Vice President – Corporate Affairs
Noven Pharmaceuticals, Inc.