FOR IMMEDIATE RELEASE

 

PALADIN REPORTS RECORD THIRD QUARTER REVENUE

Montreal, Canada, October 28, 2004 - Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical company, today reported its financial results for the three and nine-month periods ended September 30, 2004. The Company achieved record revenue for the third quarter and first nine months of 2004 and remains on track to meet its financial guidance for 2004.

Third Quarter 2004 Highlights:



“We are pleased with our progress and financial results to date in 2004. Our recent market launch of OXYTROL® significantly strengthens our urology franchise and will drive strong organic sales growth,” said Jonathan Ross Goodman, President & CEO of Paladin Labs.

Financial Results
Revenue for the three months ended September 30, 2004 increased 46% to $7.9 million compared to $5.4 million in the third quarter of 2003. Revenue for the nine months ended September 30, 2004 increased 18% to $19.9 million compared to $16.9 million in the corresponding period a year ago. To date in 2004, sales of the Company’s key promoted brands including, Androderm®, Dalacin®, Dostinex®, Estring® and Plan B®, increased by 15% compared to the first nine months of 2003.

Paladin’s 2004 third quarter earnings before interest, taxes, depreciation, and amortization (EBITDA¹) increased to $2.6 million compared to EBITDA of $903,000 in the third quarter of 2003. For the nine months ended September 30, 2004, EBITDA increased to $5.9 million compared to EBITDA of $4.2 million in the first nine months of 2003.

Net income for the third quarter was $1.0 million or $0.07 per fully diluted share compared to net income of $356,000 or $0.02 per fully diluted share in the third quarter a year ago. Net income for the nine months ended September 30, 2004 was $2.1 million or $0.14 per fully diluted share compared to net income of $787,000 or $0.05 per fully diluted share in the same period a year ago.

Gross profit, as a percentage of revenues, for the third quarter and nine months ended September 30, 2004 totalled 72% and 74% respectively compared to 74% and 75% respectively for the third quarter and nine months ended September 30, 2003.

Selling and marketing expense for the third quarter decreased 26% to $1.9 million from $2.6 million in the third quarter of 2003. Selling and marketing expense for the first nine months of 2004 decreased 36% to $5.1 million from $7.9 million in the first nine months of 2003. Decreased selling and marketing expenses in 2004 have resulted primarily from reduced promotion on Androderm®.

Research and development expense for the third quarter of 2004 increased to $774,000 from $391,000 in the same period a year ago. This increase resulted primarily from costs associated with new drug submissions for GlucaGen® and Histrelin Hydrogel Implant that were filed with Health Canada during the third quarter. In the first nine months of 2004, research and development expenses increased to $2.5 million from $873,000 in the corresponding period a year ago. This increase resulted from the aforementioned new drug submissions, an increased number of research and development projects in 2004, and $353,000 in license payments for unapproved products in the first quarter of 2004.

Amortization expense for the third quarter of 2004 increased to $1.1 million from $442,000 in the third quarter a year ago. For the nine months ended September 30, 2004, amortization expense increased to $3.0 million from $1.4 million in the corresponding period a year ago. Increased amortization expense resulted from 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 September 30, 2004, Paladin’s cash, cash equivalents and investments in marketable securities totalled $39.4 million. From this strong cash position, Paladin continues to pursue product acquisition opportunities.

Product Developments
During the third quarter, Paladin filed, on behalf of Novo Nordisk Canada Inc., a new drug submission for GlucaGen® (recombinant glucagon for injection) with the Biologics and Genetic Therapies Directorate of Health Canada. GlucaGen® is chemically identical to human glucagon, a naturally occurring peptide that selectively converts liver glycogen to glucose, relaxes smooth muscle, and increases the strength of cardiac contractions. Glucagon is indicated for emergency treatment of hypoglycemia in insulin-dependent diabetics. According to IMS Canada, in 2003, the annual market for glucagon was $4.1 million, and grew by 28% over the previous year.

Paladin filed a new drug submission for Histrelin Hydrogel Implant with the Therapeutic Products Directorate of Health Canada. Histrelin Hydrogel Implant is a unique, once-yearly luteinizing hormone-releasing hormone (LHRH) implant indicated for the treatment of prostate cancer, the most prevalent form of cancer afflicting Canadian men. According to IMS Canada, in 2003, the total LHRH agonist market for the treatment of prostate cancer was $108 million, and had a compound annual growth rate of 15% since 1998.

Paladin entered into an exclusive Canadian marketing and promotion agreement with Duramed Pharmaceuticals, Inc., a wholly-owned subsidiary of Barr Pharmaceuticals, Inc., for Loestrin® (norethindrone acetate 1.5mg/ ethinyl estradiol 0.03mg) and Minestrin® (norethindrone acetate 1.0mg/ ethinyl estradiol 0.02mg), two oral contraceptive pharmaceutical products that are currently available in Canada. Under the terms of the agreement, Paladin will assume responsibility for all marketing and promotion in Canada in exchange for a service fee. Duramed will continue to maintain control of manufacturing, distribution and logistical support.

Due to changes in market conditions, Paladin announced that it will no longer pursue its new drug submission for Statex® SR (sustained-release morphine sulfate tablets) with the Therapeutic Products Directorate of Health Canada. Paladin also announced that as a result of Health Canada's recent classification of melatonin as a natural health product, Circadin® (controlled release melatonin tablets) no longer fits within its sales and marketing strategy and will not be commercialized.

Subsequent to the end of the third quarter, on October 18, 2004, Paladin announced the Canadian launch of OXYTROL® (oxybutynin transdermal system), a unique patch medication indicated for the treatment of overactive bladder (OAB), with symptoms of urge urinary incontinence, urgency, and frequency. By bypassing initial metabolism in the liver and the gastrointestinal tract that occurs with oral medications, OXYTROL® provides relief of overactive bladder symptoms for up to four days with anticholinergic side effects comparable to placebo. According to The Canadian Continence Foundation (TCCF), approximately three million Canadians suffer from an overactive bladder and, according to IMS Canada, the total Canadian prescription market for overactive bladder exceeded $46 million in 2003.

Financial Guidance
For the year ended December 31, 2004, Paladin expects to generate $26.5 million in revenue, EBITDA¹ in the range of $6.4 million to $7.0 million, and net income in the range of $1.9 million to $2.1 million. This forecast excludes the impact of acquisitions that may be made by the Company between now and the end of 2004.

(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 and guidance 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.


Conference Call Notice

Paladin will host a conference call to discuss its third quarter results today at 10:00 a.m. EST. The dial-in number for the conference call is 1-877-211-7911 or 416-405-9310 (reference # 3107504). The call will be audio-cast live and archived for 90 days at www.financialdisclosure.ca and www.paladinlabs.com.

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]

 

September 30

December 31

 

2004

2003

 

$

$

 

(unaudited)

 

ASSETS

 

 

Current

 

 

Cash and cash equivalents

4,412 

1,991 

Short-term marketable securities

30,948 

42,556 

Accounts receivable

5,553 

248 

Inventories

2,780 

 

Other current assets

520 

2,541 

Investment tax credits receivable

176 

256 

Future income tax assets

1,969 

1,969 

Total current assets

46,358 

49,561 

 

 

 

Long-term marketable securities

4,086 

 

Property, plant and equipment

89 

132 

Intangible assets

10,731 

12,359 

Deferred charges

3,859 

2,781 

Investments

1,877 

1,877 

Future income tax credits recoverable

659 

659 

Future income tax assets

743 

1,601 

 

68,402 

68,970 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

Current

 

 

Accounts payable and accrued liabilities

4,010 

4,546 

Accounts payable to related parties

640 

170 

Income taxes payable

159 

85 

Balance of license agreements payable

1,635 

4,537 

Deferred credit

— 

300 

Total current liabilities

6,444 

9,638 

 

 

 

Shareholders’ equity

 

 

Capital stock

57,727 

57,440 

Contributed surplus

87 

87 

Other paid-in capital

519 

243 

Retained earnings

3,625 

1,562 

Total shareholders’ equity

61,958 

59,332 

 

68,402 

68,970 

 

 


STATEMENTS OF INCOME AND RETAINED EARNINGS

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

[unaudited]

 

 

Three-month period ended

September 30

Nine-month period ended

September 30

 

2004

2003

2004

2003

 

$

$

$

$

 

 

(restated)

 

(restated)

 

 

 

 

 

Revenues

7,938 

5,420 

19,932 

16,938 

Cost of sales

2,259 

1,418 

5,211 

4,188 

Gross profit

5,679 

4,002 

14,721 

12,750 

 

 

 

 

 

Selling and marketing

1,898 

2,574 

5,115 

7,947 

General and administrative

655 

580 

2,124 

1,837 

Research and development

774 

391 

2,452 

873 

Amortization

1,109 

442 

3,010 

1,377 

Interest income, net

(267)

(412)

(866)

(1,113)

Other income

— 

(11)

— 

(392)

Income before under noted items

1,510 

438 

2,886 

2,221 

Gain on disposal of license

— 

— 

— 

(504)

Write-down of long-term investments

— 

— 

— 

1,497 

Income before income taxes

1,510 

438 

2,886 

1,228 

 

 

 

 

 

Provision for income taxes

 

 

 

 

Current

25 

15 

75 

75 

Future

447 

67 

748 

366 

 

472 

82 

823 

441 

Net income (loss)

1,038 

356 

2,063 

787 

 

 

 

 

 

Earnings per share

 

 

 

 

Basic

0.07 

0.02 

0.14 

0.05 

Diluted

0.07 

0.02 

0.14 

0.05 

 

 

 

 

 

Weighted average number of shares outstanding

 

 

 

 

Basic

14,851,775 

14,789,827 

14,828,278 

14,785,069 

Diluted

14,909,415 

14,824,569 

14,908,867 

14,802,981 

 

STATEMENTS OF CASH FLOWS

[In thousands of Canadian dollars]

[unaudited]

 

Three-month period ended

September 30

Nine-month period ended

September 30

 

2004

2003

2004

2003

 

$

$

$

$

 

 

(restated)

 

(restated)

Operating activities

 

 

 

 

Net income (loss)

1,038 

356 

2,063 

787 

Add items not affecting cash

 

 

 

 

Amortization

1,124 

452 

3,057 

1,416 

Stock based compensation expense

62 

30 

280 

188 

Future income taxes

408 

558 

235 

Write-down of long-term investment

— 

— 

— 

1,497 

Imputed interest on balance of sale

— 

13 

— 

40 

Gain on disposal of license

— 

— 

— 

(504)

 

2,632 

859 

5,958 

3,659 

Net change in non-cash balances relating to operations

(139)

664 

(5,360)

526 

Cash flows from (used in) operating activities

2,493 

1,523 

598 

4,185 

 

 

 

 

 

Investing activities

 

 

 

 

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

(519)

(519)

(2,460)

(1,606)

Investment in other companies

— 

— 

— 

(1,434)

Acquisition of property, plant and equipment

(2)

(2)

(4)

(51)

Purchases of short-term marketable securities

(7,895)

(8,382)

(24,664)

(39,219)

Maturities of short-term marketable securities

7,748 

14,153 

36,272 

44,632 

Purchases of long-term marketable securities

(1,736)

(6,683)

(5,435)

(7,936)

Maturities of long-term marketable securities

268 

— 

1,349 

— 

Proceeds from disposal of assets

— 

— 

— 

869 

Cash flows from (used in) investing activities

(2,136)

(1,433)

5,058 

(4,745)

 

 

 

 

 

Financing activities

 

 

 

 

Common shares issued for cash

14 

12 

267 

53 

Account payable related to the acquisition of intellectual property

(1,039)

— 

(3,522)

— 

Repayment of share purchase loan

— 

— 

20 

20 

Cash flows from (used in) financing activities

(1,025)

12 

(3,235)

73 

 

 

 

 

 

Net change in cash and cash equivalents during the period

(668)

102 

2,421 

(487)

 

 

 

 

 

Cash and cash equivalents, beginning of period

5,080 

1,431 

1,991 

2,020 

 

 

 

 

 

Cash and cash equivalents, end of period

4,412 

1,533 

4,412 

1,533 

 

 

 

 

 

Cash and cash equivalents

4,412 

1,533 

 

 

Short-term marketable securities

30,948 

39,432 

 

 

Long-term marketable securities

4,086 

6,683 

 

 

 

39,446 

47,648