Attached files
file | filename |
---|---|
8-K - FORM 8-K - NOVELION THERAPEUTICS INC. | c97600e8vk.htm |
EX-99.2 - EXHIBIT 99.2 - NOVELION THERAPEUTICS INC. | c97600exv99w2.htm |
EXHIBIT 99.1
news release
QLT ANNOUNCES FOURTH QUARTER AND YEAR END 2009 RESULTS
Provides Guidance for 2010
For Immediate Release | March 10, 2010 |
VANCOUVER, CANADAQLT Inc. (NASDAQ: QLTI; TSX: QLT) (QLT or the Company) today reported
financial results for the fourth quarter ended December 31, 2009 and full year 2009 as well as
issued its guidance for 2010. Unless specified otherwise, all amounts are in U.S. dollars and in
accordance with U.S. GAAP.
2009 was a success for QLT on many fronts, as we concluded our non-core asset divestments,
resolved all outstanding litigation, and amended our Visudyne® agreement with Novartis,
said Bob Butchofsky, President and Chief Executive Officer of QLT. We are very excited to begin
2010 as an ophthalmology-focused company with a commercial presence in the U.S. to market Visudyne.
We are also pleased to have separately reported today an update on our punctal plug drug delivery
platform.
2009 FINANCIAL RESULTS
Financial Reporting Related to the Sale of QLT USA, Inc.
QLT sold its subsidiary, QLT USA, Inc. (QLT USA), including its Eligard® line of
products, on October 1, 2009. The Company was paid $20 million on closing, and will receive $10
million on October 1, 2010 and up to an additional $200 million in quarterly payments equal to 80%
of the royalties paid to QLT USA (now TOLMAR Therapeutics, Inc.) under the Sanofi-Synthelabo Inc.
and MediGene Aktiengesellschaft agreements. QLT has recorded an asset on its balance sheet called
Contingent Consideration ($151.1 million, split between current and long-term), which represents
the estimated present value of the expected remaining payments due from the $200 million of
quarterly payments. The cash collected each quarter for these payments will not be recorded as
revenue, rather it will draw down the Contingent Consideration asset on the balance sheet.
For the year ended December 31, 2009, QLT reported the results of the divested QLT USA business as
Income from Discontinued Operations on the Statements of Operations. This item captured the net
results of the entire QLT USA operation through the divestment date of October 1, 2009, as well as
the gain recorded in the fourth quarter related to the sale of QLT USA.
Worldwide Visudyne Product Sales
Worldwide Visudyne sales for the fourth quarter were $25.4 million, a decrease of 17.0% from sales
in the fourth quarter of 2008. Sales in the U.S. of $7.3 million were down 8.5% from the prior-year
fourth quarter, while sales outside the U.S. of $18.1 million were down 20.0%. For the full year
2009, worldwide Visudyne sales were $105.7 million, 25.5% lower than in 2008, as U.S. sales
declined 15.8% and non-U.S. sales declined 28.9%. The drop in Visudyne sales was primarily due to
continued competitive pressure throughout the world from alternative therapeutics for age-related
macular degeneration.
Page 1 of 9
QLT Revenue
QLT revenue comprises only revenue derived from sales of Visudyne. For the fourth quarter, revenue
of $10.8 million was down 8.8% from the fourth quarter of 2008, while for the full year 2009, total
revenue of $42.1 million was down 12.8% from the prior year. For both periods the drop in revenue
was due to the decline in Visudyne product sales.
QLTs share of profit from Visudyne sales in the fourth quarter was 28.5%, up from 25.3% in Q4
2008, while for the full year 2009 the profit share rate was 29.8%, up from 23.1% in 2008. The
increase in profitability for both the quarter and the year occurred as the reduction in Visudyne
expenses exceeded the decline in sales.
QLT Expenses / Other Income
For the fourth quarter, Cost of Sales was $7.5 million, up from $3.5 million in the prior year
primarily due to obsolescence charges taken by QLT and Novartis in Q4 2009 totaling approximately
$4.8 million. For the full year 2009, Cost of Sales expense was $20.2 million, compared to $14.1
million in 2008. The increase was primarily due to inventory obsolescence charges in 2009 of
approximately $9.5 million.
For the fourth quarter of 2009, expenditures for Research and Development (R&D) were $8.1 million
compared to $6.5 million in the same period of 2008. The increase occurred primarily because of
increases related to our punctal plug drug delivery program. For the full year, expenditures for
R&D were $28.6 million in 2009, down from $29.6 million in 2008, as decreased spending on Visudyne
combination studies and savings from the 2008 restructuring more than offset the increase in
spending on our punctal plug drug delivery program.
For the fourth quarter of 2009, Selling General and Administrative (SG&A) expense was $5.9 million,
up from $2.7 million in the fourth quarter of 2008. The large increase occurred because the 2009
fourth quarter included a ramp-up of expenses related to the launch of our commercial presence in
the U.S. to market Visudyne effective January 1, 2010, and because the prior year quarter benefited
from significant absorption of overhead to inventory in the period. For the full year, SG&A
expenditures of $18.3 million were essentially flat from $18.2 million reported for 2008.
Other expense or gain items of note were:
| The Litigation charge of $20.0 million for the fourth quarter and $20.7 million for the
full year 2009, which primarily related to the settlement with Massachusetts General
Hospital (MGH) announced in the fourth quarter of 2009. |
||
| The $7.5 million charge for the Purchase of In-Process Research and Development, which
related to the acquisition of the Othera Pharmaceuticals, Inc. (Othera) compound (now
QLT091568) announced in late December 2009. |
||
| The Net Foreign Exchange Loss recorded in the fourth quarter of $7.3 million, which
primarily arose because our functional currency is the Canadian dollar, while our
Contingent Consideration asset (which represents the estimated present value of the
expected remaining payments due from our sale of QLT USA) and most of our Cash and Cash
Equivalents are denominated in U.S. dollars. Therefore, during the fourth quarter when the
Canadian dollar strengthened relative to the U.S. dollar, we recognized a foreign exchange
loss on these assets in terms of their value in Canadian dollars. |
||
| The Gain on Contingent Consideration of $3.3 million, which occurred because this asset
is recorded as the estimated present value of expected future payments. Therefore, as each
quarter elapses, even if the underlying sales forecast is unchanged, we will book a gain as
we move one quarter closer to the discounted face value of the asset being realized. |
Page 2 of 9
Operating Loss
The operating loss for the fourth quarter was $38.4 million, compared to a loss of $0.9 million in
the prior-year quarter, while the full year operating loss for 2009 was $54.3 million, compared to
an operating loss in 2008 of $5.3 million. In both cases, the 2009 operating loss was negatively
impacted by the $20.0 million Litigation charge related to the MGH settlement, the $7.5 million
charge for the Purchase of In-Process R&D from Othera, and charges for Visudyne inventory
obsolescence within Cost of Sales. In addition, the full year 2008 operating loss included a gain
of $21.7 million on the sale of the Companys headquarters building and land, which was partially
offset by a $9.5 million restructuring charge.
Discontinued Operations
The Income from Discontinued Operations in the quarter of $116.7 million represented the accounting
gain on the sale of QLT USA on October 1, 2009. For the full year, the Income from Discontinued
Operations of $135.7 million also included $19.0 million of after-tax income earned from operating
the QLT USA business for the first nine months of the year, prior to the divestment date.
Although not recorded in the Statements of Operations, in the fourth quarter the Company received
$8.4 million in Contingent Consideration, representing 80% of royalties earned on
Eligard® sales that occurred during the third quarter of 2009. Further, in the first
quarter of 2010, the Company received $10.3 million, representing 80% of the royalties earned on
Eligard sales that occurred during the fourth quarter of 2009.
Earnings Per Share (EPS) / Loss Per Share, Adjusted EBITDA
QLT reported EPS of $1.49 in the fourth quarter, compared to $0.08 in the fourth quarter of 2008.
The improvement resulted primarily from the gain on the sale of QLT USA reported during the
quarter. For the full year, EPS of $1.77 in 2009 was down slightly from $1.81 in 2008, as the 2009
earnings were driven by the gain on the sale of QLT USA, while the 2008 earnings were driven by
gains from the divestments of Aczone®, Atrigel®, and our headquarters
building and land.
In the fourth quarter, non-GAAP EPS was $0.00. The items that were excluded in the determination of
non-GAAP EPS were (i) the gain on the sale of QLT USA, (ii) the Litigation charge, (iii) Visudyne
inventory charges, (iv) the Purchase of In-Process R&D, (v) foreign exchange losses related to
Contingent Consideration and intercompany debt, (vi) the gain on Contingent Consideration, (vii)
stock based compensation, (viii) interest income related to the note receivable, and (ix) the
restructuring credit. Also, for the fourth quarter we added back (within Income from Discontinued
Operations) the $10.3 million of Contingent Consideration earned for sales of Eligard during the
fourth quarter. Because we expect these quarterly earnouts of Contingent Consideration to continue
for several years, we believe this is an appropriate way to assess the underlying cash generating
capability of the Company. Adjusted EBITDA plus Contingent Consideration earned for the fourth
quarter was $3.7 million, as follows:
(In millions of United States dollars) | ||||
Non GAAP operating loss (per Exhibit 1) |
$ | (6.9 | ) | |
+ Depreciation |
0.3 | |||
+ Contingent Consideration |
10.3 | |||
Adjusted EBITDA plus Contingent Consideration |
$ | 3.7 | ||
The full reconciliation of GAAP to non-GAAP financial measures for the fourth quarter is provided
in Exhibit 1. Full year non-GAAP EPS has not been provided because following the divestment of QLT
USA, the nature of our business changed significantly and we believe that providing such a number
is not meaningful. The adjusted non-GAAP financial measures have no standardized meaning under GAAP
and therefore may not be comparable to similar measures presented by other companies. We believe
that the adjusted non-GAAP financial measures may be useful to investors for the purpose of
financial analysis of the results of our business. We use these non-GAAP measures internally to
evaluate our financial results and to establish operational goals. Certain items are excluded from
non-GAAP financial measures because we consider such items to be outside of our core operating
results or because they represent non-cash expenses or gains.
Page 3 of 9
Cash
The Companys consolidated cash balance at December 31, 2009 was $188.1 million, down from the
consolidated balance at the end of 2008 of $290.0 million (which included $124.6 million of
restricted cash that represented security for a bond posted at that time to stay execution of the
Massachusetts Eye and Ear Infirmary (MEEI) judgment). The year-over-year decrease was primarily
due to payment of the MEEI judgment, cash used for the modified Dutch Auction tender offer
completed early in 2009, and the MGH settlement, which were partially offset by cash income tax
refunds received, cash generated by the business, and up-front proceeds from the QLT USA
divestment. During the fourth quarter, as part of its normal course issuer bid program, the Company
repurchased 867 thousand shares for approximately $4.0 million.
Passive Foreign Investment Company
The Company believes that it qualified as a Passive Foreign Investment Company for 2009, which
could have adverse tax consequences for U.S. shareholders. Please refer to our Form 10-K for
additional information.
2010 GUIDANCE
| QLT is projecting that Visudyne sales will range from $90 million to $100 million in 2010,
with approximately $27 million to $31 million occurring in the United States. |
|
| Product revenue for product shipped to Novartis is expected to be approximately $6 million
to $8 million for the year, which includes approximately $4-5 million of revenue for product
that was shipped to Novartis and paid for by Novartis prior to December 31, 2009 (and was
previously recorded as deferred revenue on the Balance Sheet). |
|
| Total revenue is projected to be approximately $47 million to $53 million. |
|
| Cost of Sales is expected to be approximately $15 million to $17 million, including cost of
sales directly related to the recognition of the deferred revenue mentioned above. |
|
| R&D expense is expected to be $33 million to $37 million while SG&A expense is expected to
be $21 million to $24 million. |
|
| Payments to be earned during the year for the sale of QLT USA (representing 80% of the
royalties earned by QLT USA on Eligard sales occurring in 2010) are projected to be
approximately $32 million to $35 million. In addition, we expect to receive the $10 million
payment due from Tolmar on October 1, 2010. |
|
| Adjusted EBITDA (derived on the same basis as outlined above in our 2009 fourth quarter
results) plus Contingent Consideration earned for the sale of QLT USA, are projected to be $10
million to $15 million for the year. |
|
| With the significant change in business that has occurred, in 2010 the Company will be
using the U.S. dollar as its functional currency. Therefore, we will not be subject to foreign
exchange gains or losses on our U.S. dollar denominated assets and liabilities, including the
Contingent Consideration asset. |
|
| Each period we will assess the fair value of the contingent consideration and any changes
will flow through the Statements of Operations as gains or losses within Other Income and
Expense. |
RECENT COMPANY HIGHLIGHTS
| Announced that its board of directors authorized the repurchase of up to 5% (or
approximately 2.7 million shares) of QLTs outstanding common shares over a 12-month period on
the NASDAQ Stock Market and/or the Toronto Stock Exchange (TSX) and that the TSX accepted
the notice of QLTs intention to make a normal course issuer bid in the open market commencing
November 3, 2009 and ending November 2, 2010. During the fourth quarter of 2009, the Company
repurchased 867 thousand shares for approximately $4.0 million. |
Page 4 of 9
| Announced the settlement of QLTs litigation with MGH. Under the terms of the settlement
agreement, QLT paid US$20.0 million to MGH as payment in full for all past and future royalty
obligations under the License Agreement between QLT and MGH, in exchange for the dismissal
with prejudice of MGHs lawsuit against QLT pending in the Massachusetts District Court for
violation of Massachusetts General Law Chapter 93A, sections 2 and 11. As part of the
settlement, QLT and MGH have also released each other from any claims in connection with the
lawsuit and certain related matters. Under the existing License Agreement, QLT was obligated
to pay MGH a 0.5% royalty on Visudyne sales in the U.S. and Canada. |
|
| Initiated a Phase Ib study of QLT091001, an orally administered synthetic retinoid
replacement therapy for 11-cis-retinal, in pediatric patients with Leber Congenital Amaurosis
(LCA), an inherited progressive retinal degenerative disease that leads to retinal dysfunction
and visual impairment beginning at birth. |
|
| Announced the establishment of QLTs commercial presence in the U.S. through its newly
formed subsidiary, QLT Ophthalmics, Inc. (QOI). Effective January 1, 2010, QOI assumed
responsibility for the sales and marketing of Visudyne in the U.S. from Novartis Pharma AG. |
|
| Announced the acquisition of OT-730 (now QLT091568), a prodrug of a beta adrenergic
antagonist under investigation for the treatment of glaucoma, from privately held Othera
Pharmaceuticals, Inc. and its wholly-owned subsidiary, Othera Holding, Inc. for a one-time
payment of US$7.5 million in cash. |
|
| Announced the appointment of Mr. Joseph Turner to the Companys Board of Directors and
Audit and Risk Committee, effective February 18, 2010. His appointment brings the board
membership to eight directors. |
|
| Announced results from clinical trials on the punctal plug delivery system, including
device retention studies on third-generation plug designs and the Phase II clinical dosing
trials using the latanoprost punctal plug delivery system. Announced future expansion of the
punctal plug program to evaluate olopatadine for the treatment of allergic conjunctivitis. |
Conference call information
QLT Inc. will hold an investor conference call to discuss 2009 results on Wednesday, March 10, 2010
at 8:30 a.m. ET (5:30 a.m. PT). The call will be broadcast live via the Internet at
www.qltinc.com. To participate on the call, please dial 1-800-319-4610 (North America) or
604-638-5340 (International) before 8:30 a.m. ET. A replay of the call will be available via the
Internet and also via telephone at 1-800-319-6413 (North America) or 604-638-9010 (International),
access code 7157, followed by the # sign.
About QLT
QLT Inc. is a biotechnology company dedicated to the development and commercialization of
innovative therapies for the eye. We are focused on our commercial product Visudyne® for
the treatment of wet-AMD, and the development of drugs to be delivered in our proprietary punctal
plug devices. For more information, visit our website at www.qltinc.com.
Page 5 of 9
QLT Inc.Financial Highlights
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three months ended | Year ended | |||||||||||||||
December 31, | December 30, | |||||||||||||||
(In thousands of United States dollars, except per share information) | 2009 | 2008 | 2009 | 2008 | ||||||||||||
(Unaudited) | ||||||||||||||||
Revenues |
||||||||||||||||
Net product revenue |
$ | 10,810 | $ | 11,850 | $ | 42,106 | $ | 48,312 | ||||||||
Costs and expenses |
||||||||||||||||
Cost of sales |
7,505 | 3,482 | 20,198 | 14,145 | ||||||||||||
Research and development |
8,105 | 6,519 | 28,590 | 29,568 | ||||||||||||
Selling, general and administrative |
5,853 | 2,711 | 18,337 | 18,230 | ||||||||||||
Depreciation |
341 | 375 | 1,403 | 2,940 | ||||||||||||
Litigation |
20,012 | | 20,662 | 864 | ||||||||||||
Gain on sale of long-lived assets |
| (377 | ) | | (21,666 | ) | ||||||||||
Purchase of in-process research and development |
7,517 | | 7,517 | | ||||||||||||
Restructuring |
(119 | ) | 78 | (263 | ) | 9,517 | ||||||||||
49,214 | 12,788 | 96,444 | 53,598 | |||||||||||||
Operating loss |
(38,404 | ) | (938 | ) | (54,338 | ) | (5,286 | ) | ||||||||
Investment and other (expense) income |
||||||||||||||||
Net foreign exchange (losses) gains |
(7,289 | ) | 702 | 7,003 | 643 | |||||||||||
Interest income |
521 | 1,459 | 4,339 | 7,249 | ||||||||||||
Interest expense |
| (1,530 | ) | (1,848 | ) | (10,339 | ) | |||||||||
Gain on Contingent Consideration |
3,279 | | 3,279 | | ||||||||||||
Other |
12 | 4 | 28 | 289 | ||||||||||||
(3,477 | ) | 635 | 12,801 | (2,158 | ) | |||||||||||
Loss from continuing operations before income taxes |
(41,881 | ) | (303 | ) | (41,537 | ) | (7,444 | ) | ||||||||
Recovery (provision) for income taxes |
5,790 | (1,659 | ) | 5,317 | (1,803 | ) | ||||||||||
Loss from continuing operations |
(36,091 | ) | (1,962 | ) | (36,220 | ) | (9,247 | ) | ||||||||
Income from discontinued operations, net of income taxes |
116,673 | 7,836 | 135,654 | 144,138 | ||||||||||||
Net income |
$ | 80,582 | $ | 5,874 | $ | 99,434 | $ | 134,891 | ||||||||
Basic net income per common share |
||||||||||||||||
Continuing operations |
$ | (0.67 | ) | $ | (0.03 | ) | $ | (0.64 | ) | $ | (0.12 | ) | ||||
Discontinued operations |
2.15 | 0.11 | 2.41 | 1.93 | ||||||||||||
Net income |
$ | 1.49 | $ | 0.08 | $ | 1.77 | $ | 1.81 | ||||||||
Diluted net income per common share |
||||||||||||||||
Continuing operations |
$ | (0.67 | ) | $ | (0.03 | ) | $ | (0.64 | ) | $ | (0.12 | ) | ||||
Discontinued operations |
2.15 | 0.11 | 2.41 | 1.93 | ||||||||||||
Net income |
$ | 1.49 | $ | 0.08 | $ | 1.77 | $ | 1.81 | ||||||||
Weighted average number of common shares outstanding (in thousands) |
||||||||||||||||
Basic |
54,243 | 74,620 | 56,194 | 74,620 | ||||||||||||
Diluted |
54,243 | 74,620 | 56,194 | 74,620 |
Page 6 of 9
QLT Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In accordance with United States generally accepted accounting principles)
CONDENSED CONSOLIDATED BALANCE SHEETS
(In accordance with United States generally accepted accounting principles)
December 31, | December 31, | |||||||
(In thousands of United States dollars) | 2009 | 2008 | ||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 188,114 | $ | 165,395 | ||||
Restricted cash |
| 124,578 | ||||||
Accounts receivable |
9,465 | 11,151 | ||||||
Income taxes receivable |
4,879 | 41,801 | ||||||
Inventories |
2,874 | 3,163 | ||||||
Current portion of deferred income tax assets |
5,608 | 403 | ||||||
Mortgage receivable |
11,466 | | ||||||
Assets held for sale |
| 72,763 | ||||||
Note receivable |
9,259 | | ||||||
Contingent Consideration |
33,587 | | ||||||
Other |
6,052 | 10,474 | ||||||
271,304 | 429,728 | |||||||
Property, plant and equipment |
2,597 | 3,113 | ||||||
Deferred income tax assets |
13,320 | 5,139 | ||||||
Goodwill |
| 23,145 | ||||||
Mortgage receivable |
| 9,834 | ||||||
Long-term inventories and other assets |
14,925 | 20,799 | ||||||
Long-term Contingent consideration |
117,491 | | ||||||
$ | 419,637 | $ | 491,758 | |||||
LIABILITIES |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 3,876 | $ | 4,865 | ||||
Accrued restructuring charge |
| 314 | ||||||
Accrued liabilities |
5,574 | 129,473 | ||||||
Liabilities held for sale |
| 8,906 | ||||||
Deferred revenue |
4,244 | 4,204 | ||||||
13,694 | 147,762 | |||||||
Uncertain tax position liabilities |
1,489 | 766 | ||||||
15,183 | 148,528 | |||||||
SHAREHOLDERS EQUITY |
||||||||
Common shares |
506,023 | 702,221 | ||||||
Additional paid-in capital |
275,592 | 123,367 | ||||||
Accumulated deficit |
(480,130 | ) | (579,564 | ) | ||||
Accumulated other comprehensive income |
102,969 | 97,206 | ||||||
404,454 | 343,230 | |||||||
$ | 419,637 | $ | 491,758 | |||||
As at December 31, 2009, there were 53,789,289 issued and outstanding common shares and 5,905,283
outstanding stock options.
Page 7 of 9
QLT Inc. |
||||
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS |
||||
2009 Fourth Quarter Reconciliation of GAAP Earnings to Adjusted Non-GAAP Earnings
|
Exhibit 1 |
Three months ended | Three months ended | |||||||||||
(In millions of United States dollars, except per share | December 31, 2009 | December 31, 2009 | ||||||||||
information) | GAAP | Adjustments | Non-GAAP(1) | |||||||||
(Unaudited) | ||||||||||||
Revenues |
||||||||||||
Net product revenue |
$ | 10.8 | $ | (1.3) | (a) | $ | 9.5 | |||||
Cost and expenses |
||||||||||||
Cost of sales |
(7.5 | ) | 4.8 | (a)(b) | (2.7 | ) | ||||||
Research and development |
(8.1 | ) | 0.2 | (b) | (7.9 | ) | ||||||
Selling, general and administrative |
(5.9 | ) | 0.3 | (b) | (5.5 | ) | ||||||
Depreciation |
(0.3 | ) | | (0.3 | ) | |||||||
Litigation |
(20.0 | ) | 20.0 | (c) | | |||||||
Purchase of in-process research and development |
(7.5 | ) | 7.5 | (d) | | |||||||
Restructuring |
0.1 | (0.1) | (e) | | ||||||||
(49.2 | ) | 32.8 | (16.4 | ) | ||||||||
Operating loss |
(38.4 | ) | 31.5 | (6.9 | ) | |||||||
Investment and other (expense) income |
||||||||||||
Net foreign exchange gains |
(7.3 | ) | 6.9 | (f) | (0.4 | ) | ||||||
Interest income |
0.5 | (0.2) | (g) | 0.3 | ||||||||
Gain on contingent consideration |
3.3 | (3.3) | (h) | | ||||||||
Other |
0.0 | | 0.0 | |||||||||
(3.5 | ) | 3.3 | (0.1 | ) | ||||||||
Loss from continuing operations before income taxes |
(41.9 | ) | 34.9 | (7.0 | ) | |||||||
Recovery (provision) for income taxes |
5.8 | (9.0) | (i) | (3.3 | ) | |||||||
Loss from continuing operations |
(36.1 | ) | 25.8 | (10.3 | ) | |||||||
Income from discontinued operations, net of income taxes |
116.7 | (106.4) | (j) | 10.3 | ||||||||
Net income |
$ | 80.6 | $ | (80.6 | ) | $ | (0.0 | ) | ||||
Basic net income per common share: |
||||||||||||
Continuing operations |
$ | (0.67 | ) | $ | (0.19 | ) | ||||||
Discontinued operations |
2.15 | 0.19 | ||||||||||
Net income |
$ | 1.49 | $ | 0.00 | ||||||||
Diluted net income per common share: |
||||||||||||
Continuing operations |
$ | (0.67 | ) | $ | (0.19 | ) | ||||||
Discontinued operations |
2.15 | 0.19 | ||||||||||
Net income |
$ | 1.49 | $ | 0.00 | ||||||||
Weighted average number of common shares outstanding (in millions): |
||||||||||||
Basic |
54.2 | 54.2 | ||||||||||
Diluted |
54.2 | 54.2 |
Adjustments:
(a) | Remove inventory write-downs by QLT and Novartis. |
|
(b) | Remove stock-based compensation. |
|
(c) | Remove litigation expense. |
|
(d) | Remove purchase of in-process research and development. |
|
(e) | Remove restructuring credit. |
|
(f) | Remove foreign exchange losses related to contingent
consideration and intercompany debt. |
|
(g) | Remove interest income related to note receivable. |
|
(h) | Remove gain on contingent consideration. |
|
(i) | Remove income tax impact of the above adjustments. |
|
(j) | Remove $116.7 million gain on sale of QLT USA and add back
contingent consideration of $10.3 million based on fourth quarter
Eligard royalties. |
(1) | The adjusted non-GAAP financial measures have no standardized meaning under GAAP and therefore may not be comparable to similar measures presented by other companies.
Management believes that the adjusted non-GAAP financial measures may be useful to investors for the purpose of financial analysis of the results of the business. Management
uses these measures internally to evaluate the Companys financial performance and to set operating goals before items that are considered by management to be outside of the
Companys core operating results. Investors are cautioned to not place undue reliance on the non-GAAP financial measures, and to consider these non-GAAP financial measures in
addition to, and not as a substitute for, or superior to, financial
reporting measures prepared in accordance with GAAP. |
Page 8 of 9
QLT Inc. Media Contact:
Vancouver, Canada
Karen Peterson
Telephone: 604-707-7000 or 1-800-663-5486
kpeterson@qltinc.com
Vancouver, Canada
Karen Peterson
Telephone: 604-707-7000 or 1-800-663-5486
kpeterson@qltinc.com
The Trout Group Investor Relations Contact:
New York, USA
Christine Yang
Telephone: 646-378-2929
cyang@troutgroup.com
New York, USA
Christine Yang
Telephone: 646-378-2929
cyang@troutgroup.com
Atrigel® is a registered trademark of QLT USA, Inc.
Visudyne® is a registered trademark of Novartis AG.
Eligard® is a registered trademark of Sanofi-aventis.
Aczone® is a registered trademark of Allergan Sales, LLC.
Visudyne® is a registered trademark of Novartis AG.
Eligard® is a registered trademark of Sanofi-aventis.
Aczone® is a registered trademark of Allergan Sales, LLC.
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.
A full explanation of how QLT determines and recognizes revenue resulting from Visudyne sales is
contained in the financial statements contained in the periodic reports on Forms 10-Q and 10-K,
under the heading Significant Accounting Policies Revenue Recognition. Visudyne sales are
product sales in the U.S. by our wholly-owned U.S. subsidiary, QLT Ophthalmics, Inc., and product
sales outside the U.S. by Novartis under its agreement with 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 and constitute forward looking
information within the meaning of applicable Canadian securities laws. Forward looking statements
include, but are not limited to: our projections stated in our financial guidance, including
Visudyne sales, product revenue for product shipped to Novartis, total revenue, cost of sales, R&D
expenses, SG&A expenses, contingent consideration earned from the sale of QLT USA, adjusted EBITDA;
our expectations relating to our use of the U.S. dollar as our functional currency; statements
concerning our clinical development programs and future plans; and statements which contain
language such as: assuming, prospects, future, projects, believes, expects and
outlook. Forward-looking statements are predictions only which involve known and unknown risks,
uncertainties and other factors that may cause actual results to be materially different from those
expressed in such statements. Many such risks, uncertainties and other factors are taken into
account as part of our assumptions underlying these forward-looking statements and include, among
others, the following: the Companys future operating results are uncertain and likely to
fluctuate; currency fluctuations; the risk that sales of Visudyne or Eligard may be less than
expected; uncertainties relating to the timing and results of the clinical development and
commercialization of our products and technologies (including Visudyne and our punctal plug
technology) and the associated costs of these programs and commercialization efforts may impact our
R&D or SG&A expenses; the timing, expense and uncertainty associated with the regulatory approval
process for products; uncertainties regarding the impact of competitive products and pricing
relating to Visudyne and Eligard; risks and uncertainties associated with the safety and
effectiveness of our technology; risks and uncertainties related to the scope, validity, and
enforceability of our intellectual property rights and the impact of
patents and other intellectual property of third parties; and general economic conditions and other
factors described in detail in QLTs Annual Report on Form 10-K, 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 the current expectations of QLT and QLT does
not assume any obligation to update such information to reflect later events or developments except
as required by law.
This press release also contains forward looking information that constitutes financial
outlooks within the meaning of applicable Canadian securities laws. This information is provided
to give investors general guidance on managements current expectations of certain factors
affecting our business, including our financial results. Given the uncertainties, assumptions and
risk factors associated with this type of information, including those described above, investors
are cautioned that the information may not be appropriate for other purposes.
Page 9 of 9