FOR IMMEDIATE RELEASE

 

PALADIN REPORTS 2004 FOURTH QUARTER AND YEAR END RESULTS

- Company also provides 2005 guidance -

Montreal, Canada, February 17, 2005 - Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical company, today reported its financial results for the fourth quarter and year ended December 31, 2004. Supported by strong fourth quarter financial performance, the Company exceeded its 2004 financial guidance for revenue, EBITDA¹ and net income.

2004 Highlights

“We achieved our ninth consecutive year of record revenue. Our key promoted brands performed well in 2004 and with our recent market launch of Oxytrol®, we look forward to building on this momentum throughout 2005,” said Jonathan Ross Goodman, President and CEO of Paladin Labs.

Financial Results
Revenue for the fourth quarter of 2004 increased 17% to a record $8.1 million compared to $6.9 million in the fourth quarter of 2003. For the year ended December 31, 2004, revenue increased 17% to a record $28.0 million compared to $23.9 million in 2003. Combined sales of the Company’s key promoted brands including, Dostinex®, Estring®, Oxytrol® and Plan B® increased 36% in 2004 compared to 2003.

Paladin’s 2004 fourth quarter earnings before interest, taxes, depreciation, and amortization (EBITDA¹) increased to $1.7 million compared to EBITDA¹ of $974,000 in the fourth quarter of 2003. For the year ended December 31, 2004, EBITDA¹ increased to $7.6 million compared to EBITDA¹ of $4.6 million in 2003.

Net income for the fourth quarter of 2004 was $1.2 million or $0.08 per fully diluted share compared to a net loss of $5.0 million or $0.34 per share in the fourth quarter a year ago. Net income for the year ended December 31, 2004 was $3.2 million or $0.22 per fully diluted share compared to a net loss of $4.2 million or $0.28 per share in 2003.

Gross profit, as a percentage of revenues, for the fourth quarter and twelve months ended December 31, 2004 totalled 71% and 73% respectively, compared to 71% and 74% respectively for the fourth quarter and twelve months ended December 31, 2003.

Selling and marketing expense for the fourth quarter of 2004 decreased 24% to $2.4 million from $3.2 million in the fourth quarter of 2003. Selling and marketing expense for 2004 decreased 32% to $7.5 million from $11.1 million in 2003. Decreased selling and marketing expense in 2004 resulted primarily from reduced promotion activities for Androderm®.

Research and development expense for the fourth quarter of 2004 increased to $1.2 million from $429,000 in the same period a year ago. Research and development expense for 2004 increased to $3.6 million from $1.3 million in 2003. Increased research and development expense resulted from new drug submissions, an increased number of research and development projects in 2004, and $396,000 in-license payments for unapproved products in the first quarter.

Amortization expense for the fourth quarter of 2004 increased to $941,000 from $569,000 in the corresponding period a year ago. For the twelve months ended December 31, 2004, amortization expense increased to $4.0 million from $1.9 million in 2003. Increased amortization expense in 2004 reflects the Company’s decision to reduce the estimated useful life of the carrying value of the intellectual property associated with products that face a heightened risk of generic competition.

At December 31, 2004, Paladin’s cash, cash equivalents and investments in marketable securities totalled $42.1 million.

Product Developments
Paladin’s most significant product development in 2004 was the Canadian launch of Oxytrol®, a novel transdermal patch for the treatment of overactive bladder. Launched in October, Oxytrol® significantly strengthens Paladin’s urology franchise. According to IMS Canada, the total Canadian market for overactive bladder in 2004 was $50 million.

Other branded product developments in 2004 included: i) an exclusive Canadian distribution agreement with Transkaryotic Therapies, Inc. for ReplagalTM, an innovative, long-term enzyme replacement therapy for the treatment of Fabry disease; ii) an exclusive Canadian distribution agreement with Ovation Pharmaceuticals for Sabril® and Frisium®, two central nervous system pharmaceutical products; iii) an exclusive Canadian marketing and promotion agreement with Duramed Pharmaceuticals, Inc., for Loestrin® and Minestrin®, two oral contraceptive pharmaceutical products; and, iv) a Health Canada announcement that it is moving forward with a proposal to amend regulations, which if approved, would allow Plan B®, an emergency contraceptive pill, to be sold in Canada on a “behind-the-counter” (BTC) basis without a physician prescription.

In addition, Paladin filed a new drug submission (NDS) with Health Canada in 2004 for GlucaGen® (recombinant glucagon), an emergency treatment of hypoglycemia in insulin-dependent diabetics. According to IMS Canada, GlucaGen® will compete in a market that was valued at approximately $5.8 million in 2004 and grew by 43% over the prior year. Paladin also filed an NDS for Histrelin Hydrogel Implant, a unique, once-yearly luteinizing hormone-releasing implant for the treatment of prostate cancer. According to IMS Canada, the total LHRH for prostate cancer agonist market was $127 million in 2004, and had a compound annual growth rate of 12% since 1999. Pending Health Canada approvals, the timeline for Paladin’s Canadian market launch of Histrelin Hydrogel Implant will likely be in 2006 and GlucaGen® will follow in 2007.

Financial Outlook
Late in 2004, Paladin’s management team, supported by its Board of Directors, engaged in an extensive strategic review to accelerate the growth of the business. As a result of this strategic review, starting in 2005, Paladin will increase its capabilities to internally develop and commercialize innovative products.

For fiscal 2005, Paladin expects to generate $25 million to $26 million in revenue. This forecast excludes the impact of acquisitions and/or new product launches that may be made by the Company between now and the end of 2005.

“Supported by more than $42 million in cash and marketable securities, strong cash flow from our extensive product portfolio, and proven pharmaceutical development and marketing expertise, we believe we are well positioned to add this new competency to our business,” said Mr. Goodman.


Notice of Conference call and Web cast

Paladin’s senior management team, including: Jonathan Ross Goodman, President & Chief Executive Officer; Samira Sakhia, Chief Financial Officer; Mark Beaudet, VP Sales and Marketing; and Mark Nawacki, VP Business Development, will host an Investor Conference to discuss the Company’s year end financial results, strategic direction and 2005 revenue guidance on Friday, February 18, 2005 at 9:30 a.m. (EST). The dial-in number for the conference call is 1-877-272-5574. The presentation will also be audio-cast live via www.financialdisclosure.ca and www.paladinlabs.com.

(1) EBITDA does not have any standardized meaning prescribed by generally accepted accounting principles (GAAP) and therefore may not be comparable to similar measures presented by other public issuers. EBITDA performance is presented herein because Paladin management believes that, in addition to net income, EBITDA is a useful supplemental measure of the Company’s financial performance.

About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada’s leading specialty pharmaceutical companies. Paladin’s shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Company’s web site at www.paladinlabs.com.

This news release may contain forward-looking statements or predictions. These statements represent our judgement as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. Potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, future revenues and profitability, and obtaining marketing approval and other factors that are discussed in the Management Discussion and Analysis section of the Company's Annual Report and Annual Information Form.

For further information please contact:

Paladin Labs Inc.
Samira Sakhia
Chief Financial Officer
Paladin Labs Inc.
Tel: (514) 340-5067
E-mail: info@paladin-labs.com

The Equicom Group Inc.
Bruce Wigle
Investor Relations
Tel: (416) 815-0700 ext. 228
E-mail: bwigle@equicomgroup.com




BALANCE SHEET

[In thousands of Canadian dollars]

 

December 31

December 31

 

2004

2003

 

$

$

 

 

 

ASSETS

 

 

Current

 

 

Cash and cash equivalents

1,507 

1,991 

Short-term marketable securities

36,039 

42,556 

Accounts receivable

5,878 

248 

Inventories

2,718 

 

Other current assets

735 

2,541 

Investment tax credits receivable

— 

256 

Future income tax assets

600 

1,969 

Total current assets

47,477 

49,561 

 

 

 

Long-term marketable securities

4,578 

 

Property, plant and equipment

77 

132 

Intangible assets

11,065 

12,359 

Deferred charges

4,176 

2,781 

Investments

1,433 

1,877 

Future income tax credits recoverable

439 

659 

Future income tax assets

1,715 

1,601 

 

70,960 

68,970 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

Current

 

 

Accounts payable and accrued liabilities

4,723 

4,546 

Accounts payable to related parties

1,754 

170 

Income taxes payable

229 

85 

Balance of license agreements payable

1,062 

4,537 

Deferred credit

— 

300 

Total current liabilities

7,768 

9,638 

 

 

 

Shareholders’ equity

 

 

Capital stock

57,837 

57,440 

Other paid-in capital

554 

330 

Retained earnings

4,801 

1,562 

Total shareholders’ equity

63,192 

59,332 

 

70,960 

68,970 

 

 


STATEMENTS OF INCOME AND RETAINED EARNINGS

[In thousands of Canadian dollars except for share and per share amounts]

 

Three-month period ended

December 31

Twelve-month period ended

December

 

2004

$

2003

$

2004

$

2003

$

 

(unaudited)

(unaudited)

(audited)

(audited)

 

 

 

 

 

Revenues

8,085 

6,921 

28,017 

23,859 

Cost of sales

2,363 

1,976 

7,574 

6,164 

Gross profit

5,722 

4,945 

20,443 

17,695 

 

 

 

 

 

Selling and marketing

2,425 

3,196 

7,540 

11,142 

General and administrative

660 

790 

2,784 

2,627 

Research and development

1,229 

429 

3,681 

1,302 

Amortization

942 

569 

3,952 

1,946 

Interest income, net

(267)

(299)

(1,133)

(1,412)

Other income

— 

(28)

— 

(421)

Income before under noted items

733 

288 

3,619 

2,511 

 

 

 

 

 

Gain on disposal of investment

(577)

— 

(577)

(225)

Gain on disposal of intellectual property

             

(80)

— 

(358)

Write-down of investments

— 

526 

— 

2,023 

Write-down of intellectual property

— 

7,039 

— 

7,039 

Income before income taxes

1,310 

(7,197)

4,196 

(5,968)

 

 

 

 

 

Provision for income taxes

 

 

 

 

Current

(75)

13 

— 

88 

Future

209 

(2,250)

957 

(1,884)

 

134 

(2,237)

957 

(1,796)

Net income (loss)

1,176 

(4,960)

3,239 

(4,172)

 

 

 

 

 

Earnings per share

 

 

 

 

Basic

0.08 

(0.34)

0.22 

(0.28)

Diluted

0.08 

(0.34)

0.22 

(0.28)

 

 

 

 

 

Weighted average number of shares outstanding

 

 

 

 

Basic

14,854,971 

14,795,732 

14,834,988 

14,787,733 

Diluted

14,885,133 

14,795,732 

14,910,798 

14,787,733 

 


STATEMENTS OF CASH FLOWS

[In thousands of Canadian dollars]

 

Three-month period ended

December 31

Twelve-month period ended

December 31

 

2004

$

2003

$

2004

$

2003

$

 

(unaudited)

(unaudited)

(audited)

(audited)

 

Operating activities

 

 

 

 

Net income (loss)

1,176 

(4,960)

3,239 

(4,172)

Add items not affecting cash

 

 

 

 

Amortization

957 

633 

4,014 

2,000 

Non-cash compensation expense

40 

41 

320 

227 

Future income taxes

617 

(2,226)

1,175 

(1,991)

Gain on disposal of investment

(577)

— 

(577)

(225)

Unrealized foreign exchange (gain) loss

17 

— 

17

— 

Write-down of intellectual property

— 

7,039 

— 

7,039 

Write-down of investments in other companies

— 

526 

— 

2,023 

Imputed interest on balance of sale

— 

13 

— 

53 

Gain on disposal of intellectual property

— 

(80)

— 

(358)

 

2,230 

986 

8,188 

4,596 

Net change in non-cash balances relating to operations

1,613 

368 

(3,747)

850 

Cash flows from (used in) operating activities

3,843 

1,354 

4,441 

5,446 

 

 

 

 

 

Investing activities

 

 

 

 

Additions to pharmaceutical product licenses and rights and intellectual property and deferred charges

(1,593)

(8,412)

(4,053)

(9,969))

Investment in other companies

— 

— 

— 

(1,433)

Acquisition of property, plant and equipment

(3)

(63)

(7)

(114)

Purchases of short-term marketable securities

(18,175)

(13,390)

(42,839)

(52,608)

Maturities of short-term marketable securities

16,495 

16,948 

54,116 

61,580 

Purchases of long-term marketable securities

(3,903)

— 

(9,338)

(7,936)

Proceeds from disposal of pharmaceutical license

— 

80 

— 

420 

Proceeds from disposal of investments

1,021 

— 

1,021 

529 

Cash flows from (used in) investing activities

(6,158)

(4,837)

(1,100)

(9,531)

 

 

 

 

 

Financing activities

 

 

 

 

Account payable related to the acquisition of intellectual property

(573)

4,560 

(4,095)

4,602 

Common shares issued for cash

21 

33 

288 

86 

Repayment of share purchase loan

— 

— 

20 

20 

Payment of balance of sale

— 

(650)

— 

(650)

Cash flows from (used in) financing activities

(552)

3,943 

(3,787)

4,058 

 

 

 

 

 

Effect of exchange rate change on cash and cash equivalents

(38)

(2)

(38)

(2)

 

 

 

 

 

Net change in cash and cash equivalents during the period

(2,905)

458 

(484)

(29)

Cash and cash equivalents, beginning of period

4,412 

1,533 

1,991 

2,020 

Cash and cash equivalents, end of period

1,507 

1,991 

1,507 

1,991 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

1,507 

1,991 

 

 

Short-term marketable securities

36,039 

42,556 

 

 

Long-term marketable securities

4,578 

— 

 

 

 

42,124 

44,547