Thursday April 30, 1:18 pm Eastern Time
Company Press Release
SOURCE: QLT PhotoTherapeutics Inc.
QLT Outlines First Quarter Results, Aggressive Clinical Development
Plan, And Announces New Chief Scientific Officer At AGM
VANCOUVER, April 30 /CNW-PRN/ - QLT PhotoTherapeutics Inc. (QLT), at its annual general meeting of shareholders
today, reported continued sales growth of PHOTOFRIN(R) (porfimer sodium), steady progress in its clinical trial programs,
and the appointment of a new Chief Scientific Officer (CSO) as the company aggressively pursues expansion of its development
pipeline.
QLT, a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic
therapy, reported royalty revenue for the first quarter ended March 31, 1998 of $459,512 on end-user sales of
PHOTOFRIN(R) of about $2.2 million, up 55% from the first quarter of 1997, and up 10% from the previous quarter.
''Unit sales increased by 16% over a strong fourth quarter and largely reflect continued growth in PHOTOFRIN(R) sales in the
United States by our partner, Sanofi Pharmaceuticals,'' said Kenneth H. Galbraith, QLT's Senior Vice President and Chief
Financial Officer. ''And that increase doesn't include any contribution from U.S. sales of PHOTOFRIN(R) for treatment of
early-stage lung cancer, which began in the second quarter following the FDA's approval in January.''
QLT reported a net loss of $4,959,169 or $0.19 per common share for the first quarter of 1998, compared to a net loss of
$4,747,333 or $0.18 per common share in the previous quarter, and a net loss of $2,467,285 or $0.10 per common share in
the first quarter of 1997.
Research and development (R&D) costs for the first quarter of 1998 totaled $5,737,543, up 108% compared to the
$2,754,142 expended in the first quarter of 1997, and down 14% from the $6,707,257 that was spent in the previous quarter.
''Although the level of R&D spending was down from the fourth quarter of 1997, the Company expects to increase its R&D
efforts during the remainder of 1998, relating mainly to QLT's ongoing clinical studies of verteporfin (BPD-MA) in treating
age-related macular degeneration (AMD),'' Galbraith said.
The Company ended the first quarter with approximately $82 million in cash resources.
CEO Updates Shareholders on Clinical Trial Programs
Commenting on QLT's macular degeneration program, Dr. Levy told shareholders ''the conclusion and analysis of our pivotal
Phase III AMD trials will be the most significant and the most anticipated milestone for QLT this year. The success of this
program will play a key role in our mission of becoming a top-tier biopharmaceutical company.''
QLT and partner CIBA Vision Corporation-the eye care unit of Novartis AG-expect to submit data to various regulatory
agencies in North America and Europe for approval of verteporfin for AMD in 1999.
''While we are pleased with the progress of our ophthalmology program, this year's focus on increasing clinical development in
all our core development areas -- oncology, ophthalmology, and autoimmune diseases -- will ensure that the necessary
foundation is laid for long-term, sustainable growth,'' said Dr. Levy.
To this end, QLT also began its pivotal Phase III clinical trial of PHOTOFRIN(R) as a treatment for Barrett's esophagus during
the first quarter. QLT currently expects to be in a position to file for approval of PHOTOFRIN(R) for Barrett's esophagus in
2000.
''This highly prevalent pre-cancerous condition is blamed for the rising incidence of esophageal cancer and is a natural extension
of our approval for esophageal cancer,'' Dr. Levy said.
In the field of autoimmune disease, QLT began a Phase I trial with verteporfin as a treatment for rheumatoid arthritis, a
debilitating condition that affects more than 1% of the world's population. It follows an earlier Phase I trial of verteporfin as a
treatment for psoriatic arthritis.
''This represents a new and promising treatment modality for a disease category that affects tens of millions of people globally,''
said Dr. Levy.
Bard Partnership
QLT's new strategic alliance with C.R. Bard, Inc. -- a leading medical device company -- which Dr. Levy also announced
today, further broadens QLT's potential product pipeline into the realm of restenosis, a common vascular condition.
Under terms of the partnership, Bard will fund product development and clinical research for a therapeutic system and
procedure for reduction of arterial restenosis utilizing localized delivery of photodynamic therapy with porfimer sodium. Pending
approval, QLT will receive royalty payments or co-fund R&D at a later date in exchange for an increased share of sales
revenue.
''This is another exciting new area for QLT. Our alliance with Bard involves minimal upfront capital and resource commitments
on our part, allowing us to remain focused on our core development areas while giving us exposure to a potentially significant
new market,'' said Dr. Levy.
New Chief Scientific Officer
Dr. Levy concluded the meeting by announcing the appointment of Dr. John North to the management team. ''We are delighted
that Dr. North has decided to join us from Beaufour Ipsen as Vice President, Scientific Affairs and CSO. Already familiar with
photodynamic therapy, John has a strong background in immunology as well as extensive international experience in both
industry and academia. He brings the skills and credentials necessary to maintain, strengthen, and lead our R&D efforts.''
QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical
products for use in photodynamic therapy. QLT's innovative science has advanced photodynamic therapy beyond applications
in cancer towards potential breakthrough treatments in ophthalmology and autoimmune disease.
QLT's portfolio of products include PHOTOFRIN(R) (porfimer sodium), the world's only approved photodynamic therapy
drug, used in the treatment of various cancers throughout North America, Japan and Europe; and verteporfin (BPD-MA), a
therapy in final stages of testing to treat age-related macular degeneration, the leading cause of blindness among the elderly.
QLT PhotoTherapeutics Inc. -- Financial Highlights (Unaudited)
CONSOLIDATED STATEMENTS OF OPERATIONS
Quarter ended
(In thousands of Canadian dollars, March 31
except per share information) 1998 1997
------------------------------------------------------------------------
Revenue
Royalties on product sales $ 460 $ 297
Interest and other income 1,592 1,755
------------------------------------------------------------------------
2,052 2,052
Costs & Expenses
Research and development costs 5,737 2,754
Selling, general and administrative costs 999 1,295
Amortization 275 470
------------------------------------------------------------------------
7,011 4,519
------------------------------------------------------------------------
Net Income (Loss) $(4,959) $(2,467)
------------------------------------------------------------------------
------------------------------------------------------------------------
Net Income (Loss) per common share $(0.19) $(0.10)
------------------------------------------------------------------------
------------------------------------------------------------------------
Weighted average number of common shares
outstanding (in thousands) 26,140 25,934
------------------------------------------------------------------------
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31 December 31
(In thousands of Canadian dollars) 1998 1997
------------------------------------------------------------------------
Current assets
Cash and investment securities $ 79,372 $ 86,901
Other assets 6,399 7,268
------------------------------------------------------------------------
85,771 94,169
Long-term investment securities 2,917 2,887
Capital assets 4,014 3,768
Intangible assets 374 399
Total assets $ 93,076 $101,223
Current liabilities $ 2,539 $ 6,375
Shareholders' equity 90,537 94,848
Total liabilities and stockholders' equity $ 93,076 $101,223
All amounts shown are in Canadian dollars. At March 31, 1998, the exchange rate was approximately U.S. $1.00 equals Cdn.
$1.42.
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