FOR IMMEDIATE RELEASE

 

PALADIN REPORTS 2004 SECOND QUARTER RESULTS

- Company announces revised financial guidance for fiscal 2004 -

Montreal, Canada, July 29, 2004 - Paladin Labs Inc. (TSX: PLB), a leading Canadian specialty pharmaceutical company, today reported its financial results for the three and six-month periods ended June 30, 2004. The Company also announced revised financial guidance for fiscal 2004 as a result of the planned market launch of OXYTROL® in the fourth quarter of this year.

Second Quarter Highlights:



“We continue to make progress in expanding our product portfolio. To date in 2004, we have signed license or distribution agreements for four new products and filed two new drug submissions with Health Canada,” said Jonathan Ross Goodman, President & CEO of Paladin Labs. “Health Canada’s recent approval of OXYTROL® is a major development for us. We anticipate that OXYTROL® may become our largest product and we look forward to a fourth quarter launch.”

Financial Results
Revenue for the second quarter ended June 30, 2004, totalled $6.4 million, down slightly from a record $6.5 million in the second quarter of 2003. Revenue for the six months ended June 30, 2004 increased 4% to $12.0 million, compared to $11.5 million in the first six months of 2003. Revenue from the Company’s key promoted brands including, Androderm®, Dalacin®, Dostinex®, Estring® and Plan B® increased by 13% in the first six months of 2004 compared to the same period a year ago.

Paladin’s 2004 second quarter earnings before interest, taxes, depreciation, and amortization (EBITDA(1)) decreased 4% to $2.0 million, compared to EBITDA of $2.1 million in the second quarter of 2003. To date in 2004, Paladin’s EBITDA increased 2% to $3.3 million, compared to EBITDA of $3.2 million in the first six months of 2003.

Net income for the second quarter was $681,000 or $0.05 per fully diluted share, compared to a net loss of $142,000 or ($0.01) per share in the second quarter a year ago. Net income for the six months ended June 30, 2004 was $1.0 million or $0.07 per fully diluted share, compared to net income of $431,000 or $0.03 per fully diluted share in the same period a year ago.

Gross profit, as a percentage of revenues, for the second quarter and six months ended June 30, 2004 totalled 74% and 75% respectively, compared to 76% for both the second quarter and six months ended June 30, 2003.

Selling and marketing expense for the second quarter decreased 34% to $1.8 million from $2.7 million in the second quarter of 2003. Selling and marketing expense for the first six months of 2004 decreased 40% to $3.2 million from $5.4 million in the first six months of 2003. Decreased selling and marketing expenses in 2004 have resulted primarily from reduced promotion on Androderm®.

Research and development expense for the second quarter of 2004 increased to $500,000 from $145,000 in the second quarter a year ago. This increase resulted primarily from costs associated with new drug submissions for GlucaGen® and Histrelin Hydrogel Implant, which were filed with Health Canada subsequent to the end of the second quarter. In the first six months of 2004, research and development expenses increased to $1.7 million from $482,000 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 second quarter of 2004 increased to $1.1 million from $492,000 in the second quarter a year ago. For the six months ended June 30, 2004, amortization expense increased to $1.9 million from $935,000 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 June 30, 2004, Paladin’s cash, cash equivalents and investments in marketable securities totalled $38.5 million. From this strong cash position, Paladin continues to pursue product acquisition opportunities.

Product Developments
During the quarter, Health Canada announced that it is moving forward with a proposal to amend regulations, which if approved, would allow Plan B® (levonorgestrel) to be sold in Canada without a physician prescription. This amendment would make Plan B® available on a “behind-the-counter” basis. “Behind-the-counter” status requires professional intervention from the pharmacist at the point-of-sale.

Paladin entered into an exclusive Canadian distribution agreement with Ovation Pharmaceuticals, Inc. for Sabril® (vigabatrin) and Frisium® (clobazam), two central nervous system pharmaceutical products used to treat various epilepsy conditions. Both brands are currently available in Canada. Under the terms of the agreement, Paladin will assume responsibility for customer service, logistics, credit and collection, and pharmacovigilance support in return for a modest distribution fee. The responsibility of marketing and promotion of these brands in Canada will remain with Ovation.

Health Canada approved OXYTROL® for the treatment for overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. According to the Canadian Continence Foundation, approximately 2.9 million Canadians suffer from overactive bladder and, according to IMS Canada, the total Canadian market for the treatment of overactive bladder exceeded $46 million in 2003. Paladin expects to launch OXYTROL® in Canada during the fourth quarter of 2004.

On July 21, 2004, Paladin announced that it has 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.

On July 22, 2004, Paladin announced that it has 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.

Financial Guidance
Paladin is revising its financial guidance for 2004 due to the acquisition of OXYTROL® and the pending market launch of the product in the fourth quarter of this year, which will result in a significant increase in selling and marketing expenses during the period. As a result, Paladin is revising its 2004 EBITDA target to be between $6.4 million and $7 million, from $9.0 million, and its 2004 net income target to be between $1.9 million and $2.1 million, from $3.6 million. Paladin maintains its guidance for $26.5 million in revenue for fiscal 2004. This revised financial 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 performance.


Conference Call Notice

Paladin will host a conference call to discuss its second quarter results on Thursday, July 29, 2004, at 10:00 a.m. EST. The dial-in number for the conference call is 1-877-211-7911 or 416-405-9310 (reference # 3084031). 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 published in the Company's annual report.

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]

 

June 30

December 31

 

2004

2003

 

$

$

 

(unaudited)

 

ASSETS

 

 

Current

 

 

Cash and cash equivalents

5,080

1,991 

Short-term marketable securities

30,801

42,556 

Accounts receivable

4,755

248 

Inventories

3,066

 

Other current assets

551

2,541 

Investment tax credits receivable

169

256 

Future income tax assets

1,969

1,969 

Total current assets

46,391

49,561 

 

 

 

Long-term marketable securities

2,617

 

Property, plant and equipment

102

132 

Intangible assets

11,638

12,359 

Deferred charges

3,543

2,781 

Investments

1,877

1,877 

Future income tax credits recoverable

659

659 

Future income tax assets

1,170

1,601 

 

67,997

68,970 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

Current

 

 

Accounts payable and accrued liabilities

3,424

4,546 

Accounts payable to related parties

908

170 

Income taxes payable

126

85 

Balance of license agreements payable

2,674

4,537 

Deferred credit

19

300 

Total current liabilities

7,151

9,638 

 

 

 

Shareholders’ equity

 

 

Capital stock

57,713

57,440 

Contributed surplus

87

87 

Other paid-in capital

459

243 

Retained earnings

2,587

1,562 

Total shareholders’ equity

60,846

59,332 

 

67,997

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

June 30

Six-month period ended

June 30

 

2004

2003

2004

2003

 

$

$

$

$

 

 

(restated – see note 3)

 

(restated – see note 3)

 

 

 

 

 

Revenues

6,397 

6,453 

11,994 

11,518 

Cost of sales

1,634 

1,533 

2,952 

2,770 

Gross profit

4,763 

4,920 

9,042 

8,748 

 

 

 

 

 

Selling and marketing

1,784 

2,719 

3,217 

5,373 

General and administrative

764 

609 

1,469 

1,257 

Research and development

500 

145 

1,678 

482 

Amortization

1,110 

493 

1,901 

935 

Interest income, net

(270)

(365)

(599)

(701)

Other income

— 

(27)

— 

(381)

Income before under noted items

875 

1,346 

1,376 

1,783 

Gain on disposal of license

— 

(226)

— 

(504)

Write-down of long-term investments

— 

1,497 

— 

1,497 

Income before income taxes

875 

75 

1,376 

790 

 

 

 

 

 

Provision for income taxes

 

 

 

 

Current

25 

30 

50 

60 

Future

169 

187 

301 

299 

 

194 

217 

351 

359 

Net income (loss)

681 

(142)

1,025 

431 

 

 

 

 

 

 

Earnings per share

 

 

 

 

Basic

0.05 

(0.01)

0.07 

0.03 

Diluted

0.05 

(0.01)

0.07 

0.03 

 

 

 

 

 

Weighted average number of shares outstanding

 

 

 

 

Basic

14,829,954 

14,784,725 

14,916,400 

14,782,677 

Diluted

14,935,709 

14,800,111 

14,908,438 

14,791,495 

 


STATEMENTS OF CASH FLOWS

[In thousands of Canadian dollars]

[unaudited]

 

Three-month period ended

June 30

Six-month period ended

June 30

 

2004

2003

2004

2003

 

$

$

$

$

 

 

(restated – see note 3)

 

(restated – see note 3)

Operating activities

 

 

 

 

Net income (loss)

681 

(142)

1,025 

431 

Add items not affecting cash

 

 

 

 

Amortization

1,125 

509 

1,933 

964 

Stock based compensation expense

82 

59 

218 

158 

Future income taxes

75 

173 

150 

227 

Write-down of long-term investment

— 

1,497 

— 

1,497 

Imputed interest on balance of sale

— 

14 

— 

27 

Gain on disposal of license 

 

— 

(226)

— 

(504)

 

1,963 

1,884 

3,326 

2,800 

Net change in non-cash balances relating to operations

(1,411)

52 

(5,222)

(138)

Cash flows from (used in) operating activities

552 

1,936

(1, 896)

2,662 

 

 

 

 

 

Investing activities

 

 

 

 

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

(519)

(569)

(1,942)

(1,087)

Investment in other companies

— 

(1,434)

— 

(1,434)

Acquisition of property, plant and equipment

(2)

(24)

(2)

(49)

Purchases of short-term marketable securities

(14,016)

(26,416)

(16,769)

(30,836)

Maturities of short-term marketable securities

20,092 

18,564 

28,524 

30,478 

Purchases of long-term marketable securities

(1,902)

(1,253)

(3,698)

(1,253)

Maturities of long-term marketable securities

 1,081 

— 

1,081 

— 

Proceeds from disposal of assets

— 

529 

— 

869 

Cash flows from (used in) investing activities

4,734 

(10,603)

7,194 

(3,312)

 

 

 

 

 

Financing activities

 

 

 

 

Common shares issued for cash

217 

31 

254 

41 

Account payable related to the acquisition of intellectual property

(1,039)

— 

(2,483)

— 

Repayment of share purchase loan

20 

20 

20 

20 

Cash flows from (used in) financing activities

(802)

51 

(2,209)

61 

 

 

 

 

 

Net change in cash and cash equivalents during the period

4,484 

(8,616)

3,089 

(589)

 

 

 

 

 

Cash and cash equivalents, beginning of period

596 

10,047 

1,991 

2,020 

 

 

 

 

 

Cash and cash equivalents, end of period

5,080 

1,431 

5,080 

1,431 

 

 

 

 

 

 

Cash and cash equivalents

5,080 

1,431 

 

 

Short-term marketable securities

30,801 

43,950 

 

 

Long-term marketable securities

2,617 

1,253 

 

 

 

38,498 

46,634