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Press Releases
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| QLT Announces Q2 Results for 2002 and Reiterates Guidance |
FOR IMMEDIATE RELEASE JULY 25, 2002
VANCOUVER, CANADA—QLT Inc. (NASDAQ: QLTI; TSE: QLT) today reported financial results for the second quarter ended June 30, 2002, and reiterates guidance for 2002. Unless specified otherwise, all amounts are in Canadian dollars.
Q2 2002 Visudyne® Sales
For the three months ended June 30, 2002, Visudyne® sales were US$71.3 million (CAD$110.8 million). This represents an increase of 27% over sales in the second quarter of 2001. Visudyne sales in the U.S. for the quarter were approximately US$42.6 million (CAD$66.3 million), representing 60% of total sales for the quarter. This represents an increase of 18% over U.S. sales in the second quarter of 2001. The remaining US$28.6 million (CAD$44.5 million) relates to sales in the rest of the world, primarily Europe, and represents an increase in rest of world sales of 42% over the same period last year.
Q2 2002 Earnings per Share (EPS)
Operating EPS in the second quarter of 2002 reached $0.07 compared to $0.06 in the prior year second quarter (see (1) Non-GAAP Earnings Measures). GAAP EPS for the second quarter equaled $0.09, up $0.03 from the comparable tax-affected prior year EPS result.
2002 Annual Guidance
The company is reiterating its annual Visudyne sales guidance in the range of US$275-300 million or growth over 2001 of 25% to 35%. GAAP EPS for 2002 is expected to range from $0.40 to $0.45 (which corresponds to our previous operating/pro forma earnings guidance of $0.35 to $0.40 per share).
“We are pleased with our progress to date in 2002,” said Paul Hastings, chief executive officer and president. “As we enter the second half of the year we will continue to focus on hitting our milestones including expanding the Visudyne franchise, demonstrating further progress with our clinical development programs and managing our expenses responsibly.”
Highlights of the milestones achieved by the company in the second quarter and first few weeks of the third quarter included:
- initiating the Phase III clinical program for tariquidar in non-small-cell-lung cancer,
- receiving a positive recommendation for Visudyne approval in Europe for the occult form of the disease from the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA),
- filing the NDA for Visudyne in Japan, and, most recently,
- receiving approval in Australia and New Zealand for Visudyne in occult CNV.
Q2 Results
Revenues
The company’s revenues reached $38.3 million in the second quarter, growing by 22% from the second quarter of 2001. Revenues from Visudyne comprised $36.3 million of this total, up 22% over the same period in 2001. QLT’s share of Visudyne net profit (excluding the recovery of manufacturing and other costs) from the QLT/Novartis Ophthalmics alliance for the second quarter was 24.3% of Visudyne sales. The company is still forecasting that it will receive as its share of profit from the alliance a total of 26% to 28% of total Visudyne sales for the year 2002 as a whole. The profit share received from the QLT/NVO alliance in the second quarter of 2002 was lower than the anticipated full year rate due to continued heavy promotional expenditures early in the second quarter, and we do not expect these expenditures to continue to be heavy in the second half of 2002.
Manufacturing Expenses
Manufacturing expenses were favorably affected during the quarter by approximately $2.0 million as a result of releases of validation batches of verteporfin for injection previously on hold for second source supplier qualification.
Research and Development (R&D)
Expenditures for R&D $15.6 million were 16% higher for the three months ended June 30, 2002, than for the same period in 2001. The increase is due mainly to increased spending in the tariquidar, multiple basal cell carcinoma (MBCC) and QLT0074 development programs.
Selling, General and Administrative (SG&A)
For the second quarter of 2002, SG&A expenditures were $7.6 million representing an increase of $4.2 million or 121% over the second quarter of 2001. Approximately $2.4 million of this increase resulted from a more refined classification of expenses, compared to the prior year quarter, between R&D and SG&A. The remaining increase resulted from staffing costs, consulting fees and insurance expense.
Cash
The company’s cash reserves rose from $278 million to $287 million during the second quarter of 2002.
About Visudyne
Visudyne therapy was approved in the U.S. in April 2000, and in Europe in July 2000, for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), the leading cause of severe vision loss in patients over 50. The treatment has now been approved in 63 countries with extended approvals in over 40 countries. QLT’s revenue from Visudyne sales consists of 50% of the Visudyne net profits of the Visudyne alliance with Novartis Ophthalmics, the eye health unit of Novartis AG and reimbursement for manufacturing and other costs.
QLT Inc. is a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies to treat cancer, eye diseases and immune disorders.
Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has commercialized two products to date, including Visudyne® therapy, which is the most successfully launched ophthalmology product ever.
QLT Inc. will hold an analyst and institutional investor conference call to discuss second quarter results on Thursday, July 25, at 4:30 p.m. EST (1:30 p.m. PST). The call will be broadcast live via the Internet at www.qltinc.com. A replay of the call will be available via the Internet and also via telephone at (416) 695-5800, access code 1221537.
Visudyne is a registered trademark of Novartis AG.
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QLT Inc.:
Therese Crozier
t 604.707.7000 or 1.800.663.5486
f 604.707.7001
Media Contact:
Tamara Hicks
t 604.788.5144
QLT Inc. is listed on the Nasdaq Stock Market under the trading symbol "QLTI" and on the Toronto Stock Exchange under the trading symbol "QLT."
Certain statements in this press release constitute "forward-looking statements" of QLT within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to anticipated levels of sales of Visudyne®, estimates of QLT's share of 2002 Visudyne net profits and net income, estimates of QLT's 2002 EPS (both GAAP and Operating EPS), opportunities to expand the market for Visudyne, progress of QLT's clinical development programs, opportunities for growth beyond the Visudyne franchise and QLT's ability to manage operations and cost structures appropriately. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: the risk that future sales of Visudyne may be less than expected, our future operating results are uncertain and likely to fluctuate, currency fluctuations in our primary markets may impact our financial results, uncertainty of and timing of pricing and reimbursement may limit the future sales of Visudyne, clinical development programs may not be successful, the outcome of the pending patent and securities litigation against us may be unfavourable and have an adverse impact on our financial results, we are dependent on third-parties to commercialise Visudyne and other factors described in detail in QLT's Annual Information Form on Form 10-K, forthcoming quarterly reports on Form 10-Q and other filings with the U.S. Securities and Exchange Commission and Canadian securities regulatory authorities. Forward-looking statements are based on our current expectations and QLT is not obligated to update such information to reflect later events or developments. |
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