-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, IULId0UvFaLvUn2NwI1nk/NNjP1swo0sBX711wuXQtEfly1iKVF3q8AF826AW8OA Qob3ybL3ewzt+7yTa0ylTA== 0001299933-07-002584.txt : 20070430 0001299933-07-002584.hdr.sgml : 20070430 20070430081423 ACCESSION NUMBER: 0001299933-07-002584 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070430 ITEM INFORMATION: Results of Operations and Financial Condition FILED AS OF DATE: 20070430 DATE AS OF CHANGE: 20070430 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVEN PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000815838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 592767632 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-17254 FILM NUMBER: 07797873 BUSINESS ADDRESS: STREET 1: 11960 SW 144TH ST CITY: MIAMI STATE: FL ZIP: 33186 BUSINESS PHONE: 3052535099 MAIL ADDRESS: STREET 1: 11960 SW 144TH STREET CITY: MIAMI STATE: FL ZIP: 33185 8-K 1 htm_19876.htm LIVE FILING Noven Pharmaceuticals, Inc. (Form: 8-K)  

 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

     
Date of Report (Date of Earliest Event Reported):   April 30, 2007

Noven Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 0-17254 59-2767632
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
11960 S.W. 144th Street, Miami, Florida   33186
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   305-253-5099

Not Applicable
______________________________________________
Former name or former address, if changed since last report

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 2.02 Results of Operations and Financial Condition.

On April 30, 2007, Noven Pharmaceuticals, Inc. issued a press release announcing its financial results for the three months ended March 31, 2007. This press release, a copy of which is attached hereto as Exhibit 99.1, is "furnished" and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or incorporated by reference into a filing under the Securities Act of 1933 or the Exchange Act.






SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

         
    Noven Pharmaceuticals, Inc.
          
April 30, 2007   By:   Diane M. Barrett
       
        Name: Diane M. Barrett
        Title: Vice President and Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press Release, dated April 30, 2007, announcing Noven Pharmaceuticals, Inc.'s financial results for the quarter ended March 31, 2007.
EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

11960 Southwest 144th Street
Miami, Florida 33186
(305) 253-5099
www.noven.com

F O R            I M M E D I A T E            R E L E A S E

NOVEN REPORTS FIRST QUARTER 2007 FINANCIAL RESULTS

Quarterly EPS Increases to $0.20 from $0.02 in 2006 First Quarter

Quarterly Net Revenues Increase 90% to $19.3 Million

Miami, FL, April 30, 2007 — Noven Pharmaceuticals, Inc. (NASDAQ: NOVN), a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products, today announced financial results for the first quarter of 2007.

“We’re off to a strong start in 2007,” said Robert C. Strauss, Noven’s President, CEO & Chairman. “Sales of our Vivelle-Dot® and Daytrana™ products contributed to a 90% increase in first quarter revenues. This increase in revenues, together with a significant improvement in our overall gross margin, contributed to a near ten-fold increase in net income. Additionally, we received during the quarter the first of three potential $25 million milestones related to Shire’s sales of Daytrana™. We expect Shire’s Daytrana™ sales will trigger the second milestone, and possibly the third, in 2007.”

Noven First Quarter Results
For the quarter ended March 31, 2007 (the “current quarter”), Noven reported net income of $5.0 million ($0.20 diluted earnings per share), compared to $0.5 million ($0.02 diluted earnings per share) for the quarter ended March 31, 2006 (the “2006 quarter”).

Net revenues for the current quarter increased 90% to $19.3 million, primarily reflecting $4.4 million in Daytrana™ product sales to Shire plc, $3.0 million in Daytrana™ license revenues, and higher hormone therapy (“HT”) product sales to Novogyne Pharmaceuticals, the women’s health joint venture between Noven and Novartis Pharmaceuticals Corporation (“Novartis”).

Noven’s gross margin percentage in the current quarter was 43% compared to 29% in the 2006 quarter. Gross margin in the 2006 quarter was negatively affected by start-up and other expenses associated with initial production of Daytrana™, which was launched by Shire in the second quarter of 2006. Gross margin in the current quarter benefited from significantly higher product revenues, primarily due to Daytrana™ sales; higher production volumes, which contributed to improved overhead absorption; cost savings associated with Noven’s cost reduction program implemented in the third quarter of 2006; and a $0.5 million increase in price reconciliation payments relating to international sales of HT products, which payments increase product revenues without increasing costs. Noven continues to expect its overall gross margin for full-year 2007 to be in the 35% range.

Research and development expenses, at $3.5 million, were largely unchanged from the 2006 quarter. Marketing, general and administrative expenses increased $0.7 million or 14% to $5.4 million, primarily reflecting higher compensation costs due to additional personnel.

Noven recognized $4.9 million in earnings from Novogyne in the current quarter, 13% higher than the $4.3 million recognized in the 2006 quarter.

Novogyne First Quarter Results
Novogyne’s net income for the current quarter was $16.2 million, an 8% increase over the 2006 quarter. Current quarter net revenues at Novogyne were $33.1 million, up 5% from the 2006 quarter, reflecting lower sales and returns allowances and increased sales of Vivelle-Dot®. Novogyne’s gross margin for the current quarter increased to 79% from 76% in the 2006 quarter due to lower sales and returns allowances and increased Vivelle-Dot® sales, which have a higher margin than sales of Novogyne’s other products. Novogyne’s selling, general and administrative expenses increased 11% to $10.1 million, primarily reflecting the timing of the purchase of samples from Noven. In the current quarter, Novogyne satisfied the $6.1 million annual preferred profit distribution to Novartis required by the joint venture agreements, as it did in the 2006 quarter.

Noven Balance Sheet
At March 31, 2007, Noven had an aggregate $184.5 million in cash and cash equivalents and short-term investments, compared to $153.6 million at year-end 2006. This increase reflected receipt of a $25.0 million sales milestone relating to Shire’s 2006 sales of Daytrana™, and $9.8 million in distributions from Novogyne.

Prescription Update
Total prescriptions for Vivelle-Dot® increased 4% in the current quarter compared to the 2006 quarter, and total prescriptions for Novogyne’s products, taken as a whole, increased 2%. By comparison, the overall U.S. HT market decreased 7% during the same period. Total prescriptions for Daytrana™ (launched in June 2006) increased 14% in the current quarter compared to the quarter ended December 31, 2006, while prescriptions for ADHD stimulant therapies as a class increased 5% for the same period.

Analyst Conference Call
A conference call with management relating to Noven’s financial results will be broadcast live via the Internet at www.noven.com beginning at 9:00 a.m. Eastern time this morning, April 30th. Thereafter, a rebroadcast of the call will be accessible at the same website for at least two weeks. A taped replay of the conference call will be available from the afternoon of April 30th through May 2nd by calling 877-660-6853 (from within the U.S.) or 201-612-7415 (from outside the U.S.) and entering the access code number 286 and ID number 237437. The conference call will contain forward-looking information in addition to that contained in this press release.

About Noven
Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Noven is committed to expanding the universe of available transdermal therapies for the benefit of patients, partners and shareholders. Noven’s prescription patches are approved in over 30 countries and include Vivelle-Dot® (the most prescribed estrogen patch in the U.S.) and Daytrana™ (the first and only patch approved for the treatment of ADHD). See www.noven.com for additional information.

Contact:
Joseph C. Jones
Vice President – Corporate Affairs
(305) 253-1916

Except for historical information contained herein, the matters discussed in this press release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve substantial risks and uncertainties. When used in this press release, the word “expect” and similar expressions identify certain of such forward-looking statements. Actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements contained herein. These forward-looking statements are based largely on the current expectations of Noven and are subject to a number of risks and uncertainties that are subject to change based on factors which are, in many instances, beyond Noven’s control. By category, these risks and uncertainties include: Daytrana™ - the risk of supply interruptions of methylphenidate, which is necessary for the production of Daytrana™, including uncertainties relating to future DEA awards of methylphenidate procurement quota, which interruptions could negatively affect production, facility utilization and Noven’s revenues and gross margin in future periods as well as market acceptance for Daytrana™; the risk that Noven may encounter production inefficiencies or other issues in the process of manufacturing Daytrana™, which could adversely affect the success of the product and Noven’s results of operations; risks related to competition (including from other ADHD products marketed or under development by Shire) and market acceptance of Daytrana™ that could adversely affect the commercial success of Daytrana™ and could, among other things, limit Noven’s ability to achieve additional milestone payments under its agreement with Shire; and the possibility that the market for methylphenidate products may be negatively affected by the ongoing public debate in the United States regarding the appropriateness of using methylphenidate and other medications to treat children with ADHD, as well as the outcome of the FDA’s ongoing inquiry into the possible cardiac, psychiatric and other side effects of ADHD medications, and that the FDA’s inquiry could result in related “black-box” warnings being added to the labeling for these medications; 2007 Gross Margin – the risk that Noven may not achieve its targeted overall gross margin percentage for 2007; the risk that forecasted revenues and production volumes in 2007 are lower than expected; the risk that Noven may encounter production inefficiencies, higher than expected costs, supply interruptions or other issues in the process of manufacturing Daytrana™ and other Noven products, which could adversely affect Noven’s revenues and/or gross margin; and the expectation that Noven’s overall gross margin in 2007 will fluctuate from quarter to quarter; HT Market - risks associated with increased competition in the HT market; any further impact on Noven’s HT business due to the announcement of additional negative clinical results or otherwise, which could reduce or eliminate any profit contribution by Novogyne to Noven and/or sales of HT products from Noven to Novogyne and Novartis Pharma; the risk that Novogyne may not be able to realize the full value of the marketing rights for Noven’s CombiPatch product; and risks and uncertainties related to the fact that Vivelle-Dot® comprises a substantial majority of Novogyne’s aggregate total prescriptions; Noven’s Partners - the risk that Noven’s development partners may have different or conflicting priorities than Noven’s, which may adversely impact their ability or willingness to assist in the development and commercialization of Noven’s products or to continue the development programs; the possibility that Noven’s development programs may not proceed on schedule or as expected, which could, among other things, prevent Noven from achieving milestone objectives and/or cause delays or cancellations of programs; and the possibility that Noven’s current development priorities could render Noven unable to advance Noven’s other development projects or increase the cost of advancing those projects. For additional information regarding these and other risks associated with Noven’s business, readers should refer to Noven’s Annual Report on Form 10-K as well as other reports filed from time to time with the Securities and Exchange Commission.

1

Noven Pharmaceuticals, Inc.

                 
Statements of Operations Data:
               
(amounts in thousands, except per share   Three Months Ended
amounts) (unaudited)
  March 31,
       
     
 
  2007   2006
 
               
Revenues:
               
Product revenues – Novogyne:
               
Product sales
  $ 5,369   $ 3,087
Royalties
  1,765   1,689
 
               
Total product revenues — Novogyne
  7,134   4,776
Product revenues – third parties
  8,472   3,871
 
               
Total product revenues
  15,606   8,647
Contract and license revenues:
               
Contract
  (130 )   664
License
  3,839   881
 
               
Contract and license revenues
  3,709   1,545
 
               
Net revenues
  19,315   10,192
Expenses:
               
Cost of products sold – Novogyne
  2,959   2,143
Cost of products sold – third parties
  5,968   3,997
 
               
Total cost of products sold
  8,927   6,140
Research and development
  3,466   3,482
Marketing, general and administrative
  5,421   4,738
 
               
Total expenses
  17,814   14,360
 
               
Income (loss) from operations
  1,501   (4,168 )
Equity in earnings of Novogyne
  4,903   4,327
Interest income, net
  1,632   611
 
               
Income before income taxes
  8,036   770
Provision for income taxes
  3,000   266
 
               
Net income
  $ 5,036   $ 504
 
               
Basic earnings per share
  $ 0.20   $ 0.02
 
               
Diluted earnings per share
  $ 0.20   $ 0.02
 
               
Weighted average number of common shares outstanding:
               
Basic
  24,738   23,657
 
               
Diluted
  25,384   23,774
 
               
                 
    As Of
Balance Sheet Data:
               
(amounts in thousands) (unaudited)
  March 31, 2007
  December 31, 2006
 
               
Cash and cash equivalents
  $ 34,625     $ 9,144  
Short-term investments
    149,869       144,455  
Investment in Novogyne
    18,439       23,296  
Total assets
    283,644       281,365  
Deferred license revenues
    85,433       89,272  
Stockholders’ equity
    183,834       176,675  

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