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Home > Investors > Press Releases > Enzon Reports Strong First Quarter 2009 Results
--Company continues to improve its capital structure--
Enzon Reports Strong First Quarter 2009 Results
--Company continues to improve its capital structure--
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BRIDGEWATER,NJ - May 7, 2009 - Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) today announced its financial results for the first quarter of 2009. For the three months ended March 31, 2009, Enzon reported a net income of $6.2 million or $0.12 per diluted share, as compared to a net income of $1.5 million or $0.03 per diluted share for the first quarter of 2008. The 2009 financial results were favorably impacted by a net gain of $4.5 million on the repurchase of outstanding convertible notes at a discount to par. 

"Enzon continues to deliver solid results," said Jeffrey H. Buchalter, chairman andchief executive officer of the Company. "The repurchase of a portion of our outstanding debt at a discount to par and the efficiencies we are experiencing in our cost of goods demonstrate our continued commitment to create a sustainable biopharmaceutical company."  

Recent Highlights

  • A Phase II dose has been established for PEG-SN38.  Phase II trials are expected to open in early summer.
  • The Company reduced its debt by $20.4 million at a discount to par, which included $2.9 million tendered in January.  The outstanding long-term debt balance is now $250.0 million.
  • The Company initiated enrollment in the Phase I Survivin study for patients with solid tumors and lymphoma.
  • The next-generation Oncaspar trial continues to enroll patients.  This trial is part of the Company's plan to secure long-term supply and improve the current Oncaspar and Adagen products.
  • The Company presented preclinical data on PEG-SN38 and the LNA-based RNA antagonist at the 2009 American Association for Cancer Research (AACR) annual meeting in Denver, Colorado April 18-22, 2009.

Adjusted Financial Results

For the three months ended March 31, 2009, Enzon reported an adjusted net income of $1.7 million or $0.04 per diluted share, as compared to an adjusted net income of $1.5 million or $0.03 per diluted sharefor the three months ended March 31, 2008.

Revenues 

The following table reflects the revenues generated by product and segment for thethree-months ended March 31, 2009 and 2008.


Three Months Ended

(in millions)

 

March 31, 2009

March 31, 2008

% Change

Products

 

 

 

  Oncaspar

$14.1

$12.3

15

  DepoCyt

2.5

2.0

25

  Abelcet

5.9

7.0

(16)

  Adagen

7.2

6.1

18

Total Products

29.7

27.4

8




 

Royalties

13.6

14.7

(7)

Contract Manufacturing

5.3

6.6

(20) 

 

Total Revenues


$48.6


$48.7


-

 

 

Products Segment

Sales from the Products segment, comprised of Oncaspar®, DepoCyt®,Abelcet®, and Adagen®, increased to $29.7 millionf or the three months ended March 31, 2009, from $27.4 million for the three months ended March 31, 2008.   

Sales of Oncaspar, a PEG-enhanced version of L-asparaginase, increased to $14.1 million or 15 percent for the three months ended March 31, 2009, as compared to $12.3 million for the three months ended March 31, 2008. Oncaspar remains the gold standard of care for pediatric acute lymphoblastic leukemia (ALL).  We continue to see adoption in the adult and young adult populations.   Due to the limited shelf life of the current form of Oncaspar, buying patterns from our customers tend to fluctuate depending on the timing of anticipated use.

Sales of DepoCyt, a sustained-release formulation of the chemotherapeutic agentcytarabine arabinoside or ara-C, increased to $2.5 million for the three months ended March 31, 2009, as compared to $2.0 million for the three months ended March 31, 2008. This is a small patient population, so quarterly variability is not uncommon. 

Sales in the U.S. and Canada of Abelcet, a lipid complex formulation of amphotericin B used primarilyin the hospital to treat immuno-compromised patients with invasive fungalinfections, for the three months ended March, 31, 2009 were $5.9 million ascompared to $7.0 million in the same period of 2008.  This brand continues to experience competitive pressure from newer therapeutics in the anti-fungal market.

Sales of Adagen, an enzyme replacement therapy used to treat adenosine deaminase(ADA) deficiency in patients with severe combined immuno-deficiency disease, increased to $7.2 million for the three months ended March 31, 2009 from $6.1 million in the first quarter of 2008.   This is a small, targeted patient population, so quarterly variability is not uncommon. 

Royalties Segment

Revenues from the Company's Royalties segment for the three months ended March 31, 2009 were $13.6 million, as compared to $14.7 million for the three months ended March 31, 2008.  Royalties on PEG-INTRON, marketed by Schering-Plough, continue to comprise the majority of the Company's royalty revenue.  Schering-Plough reported a 6 percent decline in PEG-INTRON net sales in the fourth quarter of 2008, due to lower US sales. 

Contract Manufacturing Segment

The Company's revenues from its Contract Manufacturing segment decreased to $5.3 million for the three months ended March 31, 2009, as compared to $6.6 million in the corresponding period of the prior year. This includes contract manufacturing revenues related to services the Company provides for customers who require fill and finish of injectable and inhalation therapy products.  Timing of shipments to customers can often cause quarter-to-quarter variability. As previously reported, in the first quarter of 2008 the Company also recognized revenue for non-routine services for design work for its existing customers.

Cost of Product Sales and ContractManufacturing

In the first quarter of 2009, the Company's cost of goods sold decreased to $10.9million from $16.1 million in the corresponding period of the prior year.  This improvement is due in part to efficiencies from the completion of our manufacturing consolidation.  Timing of production of the Company's marketed products and products manufactured for its third-party customers will cause fluctuations in the overall cost of goods.

Research and Development

The Company's research and development expenses were $16.8 million for the three months ended March 31, 2009, as compared to $12.8 million for the three months ended March 31, 2008.  During the quarter, Enzon was successful in initiating enrollment in a Phase I study for its Survivin antagonist.  The increase is also due to the investments in the next generation Oncaspar and Adagen programs. During the first quarter of 2009, we invested $5.7 million in the next-generation programs.  As noted in our 2009 R&D guidance, the Company will continue to make significant investments in these programs to ensure long-term supply of these critical products to its patients. Enzon is also committed to making strategic investments in research and development to advance its innovative oncology pipeline. 

Selling, General and Administrative

Selling, general and administrative expenses increased slightly to $16.1 million for the three months ended March 31, 2009, as compared to $15.8 million for the three months ended March 31, 2008. The increase is primarily due to organizational enhancements the Company initiated in 2008. The Company continues to make select investments in selling, marketing, and other initiatives to support its product sales performance.   

Restructuring Charge

In February 2009, the Company reduced its headcount in most functions of the business to continue toenhance the efficiencies of the organization.  The Company recognized $1.0 million related to severancecosts in the first quarter of 2009.  In 2008, the Company reported $1.3 million in restructuring charges related to severance costs from the consolidation of the manufacturing facilities to Indianapolis, IN.  As previously reported, the Company may incur future lease termination costs associated with the manufacturing consolidation.

Other Income (Expense)

Net other income (expense) is comprised of investment income, interest expense, and other non-operating expenses. The Company reported net other income of approximately $2.5 million for the three months ended March 31, 2009 and net other expense of $0.9 million for the three months ended March 31, 2008.  The Company reported a net gain of $4.5 million from the repurchases of its outstanding 4.0 percent notes due in 2013 at a discount to par.  The Company has reduced its outstanding long-term debt balance to $250.0 million. 

Cashand Investments

Total cash reserves, which include cash, cash equivalents, short-term investments, and marketable securities, were $185.8 million as of March 31, 2009, as compared to $206.9 million as of December 31, 2008.  During the first quarter of 2009, the Company repurchased $20.4 million of its outstanding 4.0 percent notes due in 2013 for $15.6 million and paid a $5.0 million milestone payment triggered in the second-quarter of 2008 in connection with the Company's Oncaspar marketing and distribution rights. 

Reconciliation of GAAP net income (loss) to adjustednet income (loss)

The following table reconciles the Company's net income and net income per diluted share as determined in accordance with U.S.generally accepted accounting principles (GAAP) to its adjusted net income and net income per diluted share for the three months ended March 31, 2009 and 2008:

 

 

Three Months Ended 3/31/09

(In thousands, except
per-share data)

 

Three Months Ended 3/31/08

(In thousands, except
per-share data)

 

 

Net income

Per diluted share(2)

 

Net income

Per diluted share

 

 

 


 

 

   GAAP net income

$6,180

$0.12 

 

    $1,516

$0.03

 

Net realized gain related to the repurchase of debt (1)

 

(4,501)

 

-

 

               

 -

                

 

 Adjusted net income (3)

$1,679 

$0.04 

 

$1,516 

$0.03 

         

 

(1) Adjusted financial results exclude gains related to the 2009 repurchase of the 4.0 percent notesat a discount to par (plus accrued interest), offset by a write-off of relateddeferred debt offering costs.

(2)    Computation ofdiluted GAAP earnings per share assumes conversion of notes payable and the add-back of interest expense to earnings. On an adjusted basis, due to the smaller net income amount, inclusion of assumed note conversion would be anti-dilutive and is therefore excluded.  Per-share computation of individual reconciling items is not meaningful.

(3)    Adjusted net incomeand adjusted net income per diluted share, as the Company defines them, may differ from similarly named measures used by other entities and consequently, could be misleading unless all entities calculated and defined such items inthe same manner.  The Company believes that investors' understanding of its performance is enhanced by disclosing adjusted net income and adjusted net income per share reflecting adjustments for certain items that the Company deems to be non-recurring.

Conference Call and Webcast

Enzon will be hosting a conference call May 7, 2009 at 10:00 am ET. All interestedparties may access the call by using the following information:

Domestic Dial-In Number: (877) 407-9210

InternationalDial-In Number: (201) 689-8049

AccessCode:                Enzon

Enzon's conference call will also be webcast in a "listen only" mode via the Internet at http://www.investorcalendar.com.Additionally, for those parties unable to listen at the time of Enzon's conference call, a telephone rebroadcast will be available following the call from May 7,2009, at approximately 12:00 p.m. ET. This rebroadcast will end on May 14, 2009,at approximately 12:00 p.m. ET. The rebroadcast may be accessed using thefollowing information:

Domestic Dial-In Number: (877) 660-6853

International Dial-In Number: (201) 612-7415

Account Number: 286

Conference I.D.: 321316

About Enzon

Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to developing, manufacturing and commercializing important medicines for patients with cancer and other life-threatening conditions.

The Company has a portfolio of four marketed products, Oncaspar®, DepoCyt®, Abelcet® and Adagen®. Enzon's drug development programs utilize several cutting-edge approaches, including its industry-leading PEGylation technology platform and the Locked Nucleic Acid (LNA) technology.  Enzon's PEGylation technology was used to develop two of its products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing partnerships for other products developed using the technology.  Enzon also engages in contract manufacturing for several pharmaceutical companies to broaden its revenue base. Further information about Enzon and this press release can be found on the Company's web site at www.enzon.com. 

Forward Looking Statements

There are forward-looking statements contained herein, which can be identified by the use of forward-looking terminology such as the words "believes,""expects," "may," "will," "should,""potential," "anticipates," "plans" or"intends" and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments indicated in such forward-looking statements.Such factors include, but are not limited to the timing, success and cost ofclinical studies; the ability to obtain regulatory approval of products, market acceptance of, and continuing demand for, Enzon's products and the impact of competitive products and pricing. A more detailed discussion of these and other factors that could affectresults is contained in our filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2008.  These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements.  No assurance can be given that the future results covered by the forward-looking statements will be achieved. All information in this press release is as of the date of this press release and Enzon does not intend to update this information.


Enzon Pharmaceuticals, Inc. and Subsidiaries

Consolidated Statements of Operations

Three Months ended March 31, 2009 and 2008

(In thousands, except per-share amounts)

(Unaudited)

                                                                                                   

 

March 31, 2009

 

March 31,2008

Revenues:

 

 

 

  Product sales, net

$29,759

 

$27,429

  Royalties

13,562

 

14,700

  Contract manufacturing

5,317


6,644

    Total revenues

48,638

 

48,773

 

Costs and expenses:

 

 

 

  Cost of product sales and contract manufacturing

10,940

 

16,139

  Research and development                                                                            

16,783

 

12,779

  Selling, general and administrative

16,108

 

15,798

  Amortization of acquired intangible assets

167

 

167

  Restructuring charge

976

 

1,254

     Total costs and expenses

44,974

 

46,137

 

Operating income

3,664

 

2,636

 

Other income (expense):

 

 

 

  Investment income, net

967

 

2,179

  Interest expense                                                           

(3,262)

 

(3,385)

  Other, net                                                                     

4,829

 

296

 

2,534

 

(910)

Income before income tax provision

6,198

 

1,726

 

Income tax provision

18

 

210

Net income

$6,180

 

$1,516

 

 

 

 

Earnings per common share - basic

$0.14

 

$0.03

Earnings per common share - diluted

$0.12

 

$0.03

Weighted average shares - basic

  44,885

 

44,166

Weighted average shares - diluted

72,712

 

44,737                

 


 

Enzon Pharmaceuticals, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

March 31, 2009 and December 31, 2008
(In thousands)

(Unaudited)

 

 

March 31, 2009

 

December 31, 2008

 

 

 

 

 

Assets

 

 

 

 

Current assets:

 

 

 

 

  Cash and short-term investments

 

$136,822

 

$144,184

  Accounts receivable, net

 

16,080

 

11,692

  Inventories      

 

16,635

 

16,268

  Other current assets

 

8,116

 

5,281

     Total current assets

 

177,653

 

177,425

Property and equipment, net

 

43,386

 

44,585

Other assets:

 

 

 

 

  Marketable securities

 

49,016

 

62,678

  Amortizable intangible assets, net

 

57,941

 

60,654

  Other assets

 

3,910

 

3,911

    

 

110,867

 

127,243

     Total assets

 

$331,906

 

$349,253

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

Current liabilities:

 

 

 

 

    Accounts payable and accrued expenses

 

$27,481

 

$33,144

    Notes payable

 

-

 

2,950

     Total current liabilities

 

27,481

 

36,094

 

 

 

 

 

Notes payable

 

250,050

 

267,550

Other liabilities

 

4,014

 

3,948

     Total liabilities

 

281,545

 

307,592

 

 

 

 

 

Stockholders' equity

 

50,361

 

41,661

     Total liabilities and stockholders' equity

 

$331,906

 

$349,253

 

 

 

 

 

Common shares outstanding

 

45,140

 

45,032        

 

 

 

 

 

 

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