FOR IMMEDIATE RELEASE
PALADIN ANNOUNCES RECORD THIRD QUARTER RESULTS
-- Announces 2003 Revenue and Earnings Guidance --
Montreal, Canada, October 31, 2002 - Paladin Labs Inc. (TSX: PLB), a Canadian specialty pharmaceutical company focused on marketing and selling urology, endocrinology and women's health products, today announced its financial results for the third quarter and nine-month periods ended September 30, 2002. For the quarter, the Company reported record revenue and net income performance. In addition, Paladin announced an increased investment in sales and marketing to accelerate future growth and its projected impact for 2003.
Highlights of the quarter include:
- Total revenues increased 25% for the third quarter to a record $6.09 million
- Net income increased 4% for the third quarter to a record $1.53 million
- Paladin obtained the Canadian distribution rights to GlucaGen® (recombinant glucagon) from Novo Nordisk Canada Inc.
- Paladin filed a New Drug Submission ("NDS") for the approval of Statex® SR (sustained-release morphine sulfate tablets) with the Therapeutic Products Directorate ("TPD") of Health Canada
- Paladin named one of Canada's fastest growing technology companies in the 2002 Deloitte & Touche, Canadian Technology Fast 50
"Our record third quarter revenue and net income demonstrates our effectiveness in executing our business strategy and the resulting value we are creating for all our stakeholders, " said Jonathan Ross Goodman, President and CEO of Paladin Labs. "We are committed to ensuring that Paladin maintains its leadership position in the Canadian specialty pharmaceutical market. Today, we are announcing a strategic expansion of our sales and marketing efforts to accelerate Paladin's future growth."
Financial ResultsRevenue for the third quarter of 2002 increased 25% to $6.09 million, compared to $4.86 million in the third quarter a year ago. Gross profit, as a percentage of revenue, was 73% for the three-month period ended September 30, 2002, compared to 71% in the same quarter last year. Net income for the third quarter increased 4% to $1.53 million compared to $1.47 million in the same period a year ago. Diluted earnings per share for the third quarter were $0.10 per share compared to $0.12 per share in the corresponding quarter of 2001.
Selling and administrative expenses for the quarter increased 41% to $2.39 million from $1.69 million in the third quarter last year. This increase was primarily due to increased sales and marketing spending associated with new product launches and higher staffing costs related to growth of the Company's product line during 2001 and 2002. Amortization expense increased 160% to $0.43 million for the quarter ended September 30, 2002 from $0.17 million for the same quarter last year. This increase reflects the impact of amortization expense related to the Company's acquisition of licenses, rights and intellectual property during fiscal 2001 and 2002.
For the nine-month period ended September 30, 2002, revenue increased 39% to $17.81 million compared to $12.89 million in the first nine months of 2001. Net income for the first nine months of 2002 increased 47% to $4.37 million from $2.98 million for the same period a year ago. Diluted earnings per share increased 29% to $0.31 per share compared to $0.24 per share in the corresponding period last year.
Product DevelopmentsDuring the quarter, Paladin obtained the Canadian distribution rights to GlucaGen® (recombinant glucagon) from Novo Nordisk Canada Inc. GlucaGen® is chemically identical to human glucagon, a naturally occurring peptide that is indicated for emergency treatment of hypoglycemia in insulin-dependent diabetics and for relaxation of the gastrointestinal tract during routine radiology procedures. Paladin will work with Novo Nordisk Canada Inc., to file a NDS for GlucaGen® with the Biologics and Gene Therapies Directorate of Health Canada within the coming year.
On September 5, 2002, Paladin announced it had filed a NDS for the approval of Statex® SR (sustained-release morphine sulfate tablets) with the TPD of Health Canada. The submission seeks Health Canada's approval for the use of Statex® SR in Canada for the relief of severe pain requiring the prolonged use of an opioid analgesic preparation. Studies performed by the National Cancer Institute of Canada (Clinical Trials Group) have demonstrated that Statex® SR is equivalent to Purdue Pharma L.P.'s MS-Contin®, a leading controlled release morphine sulfate tablet brand, in terms of average scores in pain, nausea, drowsiness and insomnia.
Paladin received a request from Health Canada in July 2002 for additional information on its application to have Plan B™ switched to non-prescription status. The switch from prescription to non-prescription status will allow Canadian women to have more timely access to this highly effective emergency contraceptive pill. Paladin completed its response to Health Canada's request within the 90-calendar day window.
Subsequent to the end of Paladin's third quarter, on October 3, 2002, the Company announced that it had entered into a licensing agreement with Hydro Med Sciences, Inc., for the Canadian rights to its unique, once-yearly implant (Histrelin Hydrogel Implant) indicated for the treatment of advanced prostate cancer. It is anticipated that a regulatory submission will be filed in Canada by the end of the Company's first quarter of fiscal 2004.
Financial GuidancePaladin is comfortable with previously announced projected estimates for revenue of $23 million for fiscal 2002. The Company expects diluted earnings for fiscal 2002 to be $0.36 per share.
For 2003, Paladin is projecting total revenue of $26 million and net income of $2 million. This projection excludes the impact of acquisitions that may be made by the Company in 2003. The Company intends to significantly increase the sales and marketing efforts behind Androderm®, Muse®, Plan B™, Oesclim®, and Estring®. The increased sales and marketing efforts will boost Paladin's reach from 1,375 physicians to more than 7,500 physicians.
"Paladin has reached a pivotal point in its development. It's time to take the next step to strengthen our leadership position in the Canadian specialty pharmaceutical market. As Androderm®, Muse®, Plan B™, Oesclim®, and Estring® are at an early stage in their product life cycles, we are extending more marketing and sales support to them in order to capitalize on strong growth opportunities," said Jonathan Ross Goodman. "We expect these initiatives to result in greater long term value for our shareholders."
For more information about the fiscal 2003 financial guidance, a detailed presentation is now available in the products section of Paladin's Web site at: http://www.paladinlabs.com/forinvestors/presentations.html
Conference Call NoticePaladin will host a conference call to discuss its third quarter 2002 results on Thursday, October 31 at 10:00 a.m. EST. The dial in number for the conference call is 1-800-273-9672 or 1-416-695-5806 and the reference number is 1298925.
The call will be audio-cast live and archived for 90 days at www.financialdisclosure.ca and www.paladinlabs.com
About Androderm® Inc.
Androderm®, the only testosterone patch available in Canada, is indicated for the treatment of testosterone deficiency in men. Unusually low testosterone levels in men can be due to the natural ageing process or as a result of a variety of other conditions. Testosterone deficiency is characterized by symptoms of fatigue, negative moods, and loss of sex drive.
It is estimated that testosterone deficiency or andropause afflicts more than one million Canadian men, only five per cent of whom are being treated in Canada today. Androderm®'s effectiveness in treating testosterone deficiency along with its convenient once-a-day format makes it an innovative new option for the treatment of testosterone deficiency. Launched by Paladin in 2001, Androderm® is competing in a $23 million market that has grown at a four-year compounded annual growth rate of over 30%.About Estring® Inc.
Estring® is an intravaginal ring that provides sustained local release of estrogen over a three-month period. Estring® is indicated for the treatment of post-menopausal urogenital complaints. Estring® offers women the option of taking a local estrogen therapy over other systemic hormone replacement therapy.
Paladin obtained the rights to distribute Estring® from Pharmacia Canada Inc. in January 2002. Estring® competes in a $150 million female hormone replacement therapy market, which is dominated by systemic therapies that have recently come under examination.About Plan B™ Inc.
Plan B™ is the first progestin-only pill indicated to prevent pregnancy after a contraceptive failure or unprotected sex. It is highly effective and produces significantly less nausea and vomiting than other emergency contraceptive regimens. Health Canada approved Plan BTM as a prescription product in February 2000. During 2001, the provinces of British Columbia and Quebec authorized pharmacists to prescribe Plan B™. During 2002, Paladin, on behalf of Women's Capital Corp., submitted an application to Health Canada to change Plan BTM from prescription-only to non-prescription status.
In Canada, there are approximately 3,000,000 cases of unprotected sex annually due to either lack of use of a contraceptive or a contraceptive failure. This results in an estimated 235,000 unintended pregnancies and 112,500 abortions annually.About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Quebec, is a rapidly growing 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 most profitable publicly-traded pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the Paladin 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
Tel: 514-340-5067
E-mail: info@paladin-labs.com
Web Site: www.paladinlabs.comThe Equicom Group Inc.
Bruce Wigle
Investor Relations
Tel: (416) 815-0700 ext. 228
E-mail: bwigle@equicomgroup.com
Paladin Labs Inc.
Balance Sheet
[In thousands of Canadian dollars]
September 30
December 31
2002
2001
$
$
(unaudited)
ASSETS
Current
Cash and cash equivalents
7,437
1,978
Temporary investments
39,973
20,470
Accounts receivable
1,944
2,067
Inventories
—
50
Income tax credits receivable
579
487
Future income tax assets
2,275
2,275
Total current assets
52,208
27,327
Capital assets
14,545
12,530
Investments, at cost
2,771
2,771
Future income tax credits receivable
1,267
347
Future income tax assets
347
2,216
71,138
45,191
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
Accounts payable and accrued liabilities
6,277
3,924
Income taxes payable
169
181
Deferred credit
1,638
1,638
Total current liabilities
8,084
5,743
Balance of sale payable
584
544
Deferred credit
—
935
Future income tax liability
133
133
8,801
7,355
Shareholders’ equity
Capital stock
57,281
37,154
Contributed surplus
87
87
Other paid-in capital
23
23
Retained earnings
4,946
572
Total shareholders’ equity
62,337
37,836
71,138
45,191
STATEMENTS OF INCOME AND RETAINED EARNINGS
[In thousands of Canadian dollars except for share and per share amounts]
Three-month period ended
September 30
Nine-month period ended
September 30
2002
2001
2002
2001
$
$
$
$
(unaudited)
(unaudited)
(unaudited)
(unaudited)
Revenues
6,087
4,859
17,812
12,858
Cost of sales
1,615
1,407
4,764
4,112
Gross profit
4,472
3,452
13,048
8,746
Selling and administrative
2,393
1,691
6,546
5,263
Research and development
203
248
791
492
Amortization
433
167
1,289
476
Interest income, net
(365)
(232)
(710)
(828)
Income before under noted items
1,808
1,578
5,132
3,343
Gain on disposal of license
—
109
—
109
Income before income taxes
1,808
1,687
5,132
3,452
Provision for income taxes
Current
21
5
81
15
Future
254
209
677
454
275
214
758
469
Net income
1,533
1,473
4,374
2,983
Earnings per share
Basic
0.10
0.12
0.32
0.24
Diluted
0.10
0.12
0.31
0.24
Weighted average number of shares outstanding
Basic
14,777,171
12,428,420
13,724,021
12,410,020
Diluted
15,052,244
12,486,145
13,956,901
12,476,703
STATEMENTS OF CASH FLOWS
[In thousands of Canadian dollars]
Three-month period ended
September 30
Nine-month period ended
September 30
2002
2001
2002
2001
$
$
$
$
(unaudited)
(unaudited)
(unaudited)
(unaudited)
Operating activities
Net income
1,533
1,473
4,374
2,984
Add items not affecting cash
Amortization
433
167
1,289
476
Future income taxes
227
173
15
371
Imputed interest on balance of sale
13
12
40
37
Gain on disposal of license
—
(109)
—
(109)
2,206
1,716
5,718
3,759
Net change in non-cash balances relating to operations
1,163
(518)
1,241
(514)
Cash flows from (used in) operating activities
3,369
1,198
6,959
3,245
Investing activities
Acquisition of capital assets
(16)
—
(33)
(11)
Additions to pharmaceutical product licenses and rights
(519)
(2,311)
(3,270)
(5,126)
Accounts payable related to the acquisition of intellectual property
—
—
1,179
—
Investments
—
(211)
—
(211)
Net decrease (increase) in temporary investments)
(611)
(7,400)
(19,503)
1,627
Cash flows (used in) from financing activities
(1,146)
(9,922)
(21,627)
(3,722)
Financing activities
Issuance of common shares
9
103
232
236
Issuance/conversion of special warrants
—
—
20,952
—
Share issue costs
—
—
(1,057)
—
Cash flows from financing activities
9
103
20,127
236
Net increase (decrease) in cash and cash equivalents
2,232
(8,621)
5,459
(241)
Cash and cash equivalents, beginning of period
5,205
11,238
1,978
2,858
Cash and cash equivalents, end of period
7,437
2,617
7,437
2,617
Cash and cash equivalents
7,437
2,617
Temporary investments
39,973
19,855
47,410
22,472