Releases financial results for fiscal year ended March 31, 2006
LANGLEY, BC, June 13 /PRNewswire-FirstCall/ -- AnorMED (TSX:AOM,
AMEX:AOM) today released its financial results for the fiscal year
ended March 31, 2006 and issued a statement providing a current
outlook for the next 12 months and beyond based on the new
strategic direction for the Company. Kenneth Galbraith, Chairman
and Acting CEO, said the new strategy is designed to transform the
Company from a research focus into a successful, fully-integrated
biopharmaceutical company built around the timely development and
commercialization of MOZOBIL in order to maximize shareholder value
in both the near-term and long-term. MOZOBIL is now being evaluated
in two Phase III clinical studies after demonstrating the potential
to help cancer patients successfully undergo stem cell transplants
in Phase II clinical studies. "The new Board of Directors and
management believe that MOZOBIL presents a substantial opportunity
to improve outcomes for patients undergoing stem cell transplants
and that this opportunity is not yet fully appreciated by the
financial markets. As a result, the current market value of the
Company's shares remains significantly below that of other
comparable companies that retain the commercial rights to their
late-stage products," said Mr. Galbraith. "This strategic direction
was selected by the new Board of Directors and management in the
belief that the best way to maximize near-term and long-term
shareholder value is to complete the final stages of MOZOBIL
development in North America and Europe independent of strategic
partners and then implement a global commercial strategy involving
the appropriate combination of direct marketing by AnorMED and
arrangements with local distributors and regional partners." "The
important near-term goal will be to complete the current Phase III
studies of MOZOBIL and announce top-line data from both studies in
patients with multiple myeloma and non-Hodgkin's lymphoma by the
second quarter of calendar 2007. Assuming successful results from
these two studies, the Company would expect to complete filings for
marketing approval in the U.S., Canada and Europe in 2007 and 2008.
The important three-year goal is to provide broad access to MOZOBIL
for transplant patients in the U.S., Canada and Europe by no later
than mid-2009, subject to the receipt of approvals from regulatory
agencies based on these filings," Mr. Galbraith said. Key Events
/Milestones for the Next 12 Months for MOZOBIL In implementing its
new strategy the Company expects the following key events and
milestones for MOZOBIL to occur over the next 12 months with the
corresponding calendar quarter indicated where appropriate: -
Complete 100% patient enrolment in the Phase III studies of MOZOBIL
for both multiple myeloma and non-Hodgkin's lymphoma by Q4 2006 -
Initiate additional Phase II studies for MOZOBIL in transplant
indications in the U.S., Canada and Europe by Q1 2007 and Q2 2007 -
Announce top-line data for both Phase III MOZOBIL studies by Q2
2007 - Initiate two pilot studies for new MOZOBIL indications by Q1
2007 - Establish initial Company development team in Europe for
MOZOBIL by Q1 2007 MOZOBIL Development MOZOBIL development
continues to progress on schedule with two Phase III studies
ongoing at 45 transplant centers in the U.S, Canada and Europe. As
at June 12, 2006, 276 patients of the required 300 patients (or
92%) had been enrolled in the Phase III study of patients with
multiple myeloma and 227 patients of the required 300 patients (or
76%) had been enrolled in the Phase III study of patients with
non-Hodgkin's lymphoma. We still expect to complete the full
enrolment of both studies in 2006. Further updates regarding the
number of enrolled patients will continue to be provided on a
regular basis and we expect to make a public announcement when the
last patient is enrolled in each study. Based on the current status
of patient enrolment and the required follow-up period for each
study, we expect to be able to announce top-line data by the second
calendar quarter of 2007. If the clinical studies are successful,
we would expect to be able to file a New Drug Application (NDA) for
marketing approval in the U.S. by the end of 2007 and the full data
would be published or presented at a medical conference in
conjunction with this filing. We intend to request a priority
review for our U.S. NDA filing which, if granted, would require a
determination by the U.S. Food and Drug Administration (FDA) within
six months of filing rather than the normal 12 months.
Subsequently, the Company would expect to make additional filings
seeking marketing approval in Canada and Europe in 2008. We also
expect to initiate a series of additional Company-sponsored
clinical studies in the U.S. and Europe involving MOZOBIL
commencing in the first calendar quarter of 2007 to address
expanded uses in transplant and to investigate potential additional
applications for this drug candidate. MOZOBIL Commercial Strategy
The Company believes that the optimal global commercial strategy
for MOZOBIL is a combination of direct marketing by AnorMED sales
forces and the use of local distributors and regional partners. We
are completing the necessary market planning and research
activities and expect to commence building the appropriate
commercial infrastructure for MOZOBIL in 2007 after top-line data
is available. AMD070 Development The ongoing proof-of-principle
clinical study of AMD070 in HIV patients ("XACT") is continuing to
accrue patients at one site in the U.S. and one site in the United
Kingdom. In the first quarter of Fiscal 2007, we initiated a Phase
I clinical study for AMD070 called XIST, which is a drug
interaction study in healthy volunteers. We also are continuing
over the next several quarters with our preclinical safety studies
of lead formulations of AMD070. Any additional efficacy or safety
data will be submitted for presentation at the Conference on
Retroviruses and Opportunistic Infections scheduled to be held in
Los Angeles, California from February 25 to 28, 2007. Research
Programs We have several compounds from our CCR5 entry inhibitor
anti-HIV research program progressing through multi-dose
preclinical safety testing. As this research program has been
ongoing for several years, we intend to reallocate future research
efforts to other programs if a lead clinical candidate is not
identified by the end of calendar 2006. We are also continuing our
research efforts with preclinical work in CXCR4 in oncology.
European Development Organization We will take active steps this
year to build our capabilities to undertake development work on
MOZOBIL in Europe. A small development team is planned to be
established in Europe by the first calendar quarter of 2007. This
organization is expected to allow the Company to initiate
additional clinical studies for MOZOBIL in the five major European
markets in order to build clinical experience at major transplant
centres in those markets with MOZOBIL and to explore new
indications to expand the potential use of MOZOBIL after the
initial marketing approvals. This team would also manage any
partnering arrangements we may enter into in Europe. Based on our
expectation that the results from the Phase III studies for MOZOBIL
will be positive, we plan to start building an expanded development
organization to support the filing for European approval in 2008
and determining the extent of our own commercial infrastructure in
the major European markets and the extent of the arrangements we
will enter with local distributors and regional partners for the
sale of MOZOBIL in the remaining European markets. Human Resource
Strategy In order to execute the new strategic direction in Fiscal
2007, we will need to expand our capabilities in regulatory
affairs, clinical research and quality assurance. We expect to
increase our workforce by approximately 25 to 30 employees by March
31, 2007 in the U.S., Canada and Europe. Successful results from
the ongoing Phase III studies of MOZOBIL would require us to
increase our workforce further to support the expanded development
and eventual commercialization of MOZOBIL. We expect to complete
the executive searches for a new President and Chief Executive
Officer and a Vice President of Regulatory Affairs during the 2007
fiscal year. In the interim, the Board is confident that the
current management team is capable of executing the current plan
and accomplishing the corporate goals identified for the next 12
months. Appointment of Paul Brennan as an Additional Director The
Board of Directors also announced the appointment of Paul Brennan,
Acting President and Vice President, Business Development as a
Director of the Company. Mr. Brennan will serve as a management
Director until such time as the new President and Chief Executive
Officer is hired. Financial Strategy As of March 31, 2006, the
Company had cash resources of approximately $62 million. In order
to support the continued development and commercialization of
MOZOBIL and the advancement of the product pipeline over the next
three years, the Company will need to access additional capital to
fund development costs and pre-commercial activities. Possible
mechanisms for improving the Company's financial longevity and
increasing flexibility in future spending may include raising
additional equity capital, monetizing non-core assets, partnering
of non-MOZOBIL programs and partnering arrangements for MOZOBIL. In
the event that sufficient capital is unavailable from these sources
on a timely basis, the Company could take steps to reduce its burn
rate by reducing or deferring spending on non-MOZOBIL programs or
delaying the expansion of additional MOZOBIL studies prior to
top-line data becoming available. Financial Results for Year Ended
March 31, 2006 For the fourth quarter ended March 31, 2006, we
reported a net loss of $12,784,000 (or $0.32 per common share) as
compared to a net loss of $11,403,000 (or $0.34 per common share)
in the third quarter of Fiscal 2006 and a net loss of $7,619,000
(or $0.24 per common share) in the fourth quarter of Fiscal 2005.
The Company reported a net loss of $41,467,000 (or $1.20 per share)
for the fiscal year ended March 31, 2006 as compared to a net loss
of $2,169,000 (or $0.07 per share) in Fiscal 2005. The increased
loss was consistent with the increased spending required for the
Phase III trials for MOZOBIL. Also, the reduced loss for Fiscal
2005 reflected a substantial milestone payment of approximately
$21.6 million from Shire Pharmaceuticals from the restructured
collaboration between the Company and Shire relating to FOSRENOL.
The Company expects to receive additional milestone payments of
U.S. $6 million from Shire in Fiscal 2007 based on the receipt of
additional approvals of FOSRENOL in Europe. As at March 31, 2006,
the Company had total cash resources of approximately $62 million.
The Company's cash position was strengthened during the year as a
result of a financing completed in December 2005 for net proceeds
of approximately $32 million. Capital expenditures for the fiscal
year totalled approximately $1.6 million relating mainly to a
facility expansion to accommodate growth in the number of employees
and a software installation to allow electronic filings for our FDA
submission expected in 2007. Included in general and administrative
expenses for the fiscal year are approximately $1.3 million in
costs relating to the Special Meeting of Shareholders held on April
21, 2006. A further amount of $1.975 million is expected to be
charged to expense in the first fiscal quarter of 2007 relating to
the remaining costs incurred for the special meeting in Fiscal
2007. Also, a charge of $4.1 million will be recorded in the first
fiscal quarter of 2007 relating to potential severance and
retention payments to management as a result of the election of a
new Board by shareholders on April 21, 2006. About MOZOBIL MOZOBIL
is a stem cell mobilizer used in stem cell transplants, a procedure
used to restore the immune system of cancer patients who have had
treatments that previously destroyed their immune cells. MOZOBIL
works by triggering the rapid movement of stem cells out of the
bone marrow and into circulating blood. Once in the circulating
blood, the stem cells can be collected for use in a stem cell
transplant. In Phase II studies, MOZOBIL consistently demonstrated
the ability to help cancer patients generate more of their own stem
cells, resulting in an increase in the potential for these patients
to be able to undergo a stem cell transplant. MOZOBIL is currently
the subject of two Phase III clinical studies at 45 major centres
in the U.S., Canada and Europe involving 600 cancer patients with
either non-Hodgkin's lymphoma or multiple myeloma and who are
undergoing autologous stem cell transplantation as a part of their
treatment. Both Phase III studies are randomized, double-blind,
placebo-controlled, comparative trials of MOZOBIL plus G-CSF versus
placebo plus G-CSF, the current standard drug used to stimulate
additional stem cells within bone marrow. The Company expects to
complete patient recruitment of both Phase III studies by the end
of 2006 and announce top-line results from the studies by the
second calendar quarter of 2007. If successful, the results of
these clinical studies would be the basis for filings in the United
States, Canada, the E.U. and other countries seeking approval to
market MOZOBIL for these indications. About AnorMED Inc. AnorMED is
a chemistry-based biopharmaceutical company focused on the
discovery, development and commercialization of new therapeutic
products in the areas of hematology, oncology and HIV, based on the
Company's research into chemokine receptors. The Company's product
pipeline includes MOZOBIL, currently in Phase III studies in cancer
patients undergoing stem cell transplants; AMD070, currently in
Phase I/II studies in HIV patients; and several novel classes of
compounds in preclinical development that target specific chemokine
receptors known to be involved in a variety of diseases. Additional
information on AnorMED Inc. is available on the Company's website
http://www.anormed.com/. This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Act of 1995 or forward-looking information
within the meaning of applicable securities laws in Canada.
Forward-looking statements or information include, but are not
limited to, statements about: our expectations with respect to
enrolment for, completion of, and reporting on our various clinical
trials; our expectations for the timing of regulatory approvals for
MOZOBIL; our plans to commence building commercial infrastructure
for MOZOBIL; our intentions relating to the future of the CCR5
research program; our plans for an EU development organization; our
expectations with respect to increasing our workforce and
completing executive searches; and, our plans in the event
sufficient capital is not available from alternative sources of
funding. The words "anticipates", "believes", "budgets", "could",
"estimates", "expects", "forecasts", "intends", "may", "might",
"plans", "projects", "schedule", "should", "will", "would" and
similar expressions are intended to identify forward-looking
statements or information, although not all forward-looking
statements or information contain these identifying words. Readers
are cautioned that the plans, intentions or expectations disclosed
in any forward-looking statements or information may not be
achieved and that they should not place undue reliance on any
forward-looking statements or information. Actual results or events
could differ materially from the plans, intentions and expectations
expressed or implied in any forward-looking statements or
information as a result of numerous risks, uncertainties and other
factors, including those relating to: our early stage of
development, particularly the inherent risks and uncertainties
associated with (i) developing new drug candidates generally, and
specifically, drug candidates that interact with chemokine
receptors, (ii) demonstrating the safety and efficacy of these drug
candidates in clinical studies in humans, and (iii) obtaining
regulatory approval to commercialize these drug candidates; our
drug candidates require time- consuming and costly preclinical and
clinical testing and regulatory approvals prior to
commercialization; clinical studies and regulatory approvals of our
drug candidates are subject to delays, and may not be completed or
granted on expected timetables, if at all, and such delays may
increase our costs; our ability to raise substantial additional
financing required to fund further research and development,
conduct planned preclinical and clinical studies, and obtain
regulatory approvals; development or commercialization of similar
products by our competitors, many of which are more established and
have greater financial resources than we do; our limited
manufacturing, sales, marketing and distribution experience; our
ability to obtain raw materials and manufacture products in
commercial quantities at acceptable costs; and, our ability to
successfully attract and retain skilled and experienced personnel.
Other risks, uncertainties and factors that our management believes
could cause actual results or events to differ materially from the
forward-looking statements or information are discussed in our
filings with the Securities and Exchange Commission and the
securities regulatory authorities in Canada. Although we have
attempted to identify important risks, uncertainties and other
factors that could cause actual results or events to differ
materially from those expressed or implied in the forward-looking
statements or information, there may be other factors that cause
actual results or events to differ from those expressed or implied
in the forward-looking statements or information. We undertake no
obligation to revise or update any forward- looking statements or
information as a result of new information, future events or
otherwise after the date hereof, except as may be required by law.
Teleconference Call Notification: June 13, 2006 4:30 pm/EDT (1:30
pm/PDT)
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On Tuesday, June 13, 2006, AnorMED Inc. will host a teleconference
call at 4:30 pm/EDT (1:30 pm/PDT). To participate in the
teleconference please dial, 1-800-396-0424 in Canada and the U.S.
or 1-416-641-6669 Internationally before 4:30 pm/EDT. This call
will be taped, available one hour after the teleconference, and on
replay until July 13, 2006. To hear a complete replay, please call
1-800-558-5253. The reservation number required for access is
21294294. This call will also be webcast from AnorMED's website at
http://www.anormed.com/. For further information: Company Contact:
W.J. (Bill) Adams, Chief Financial Officer, Tel: 604-530-1057 or
Kim Nelson, Manager Investor Relations, Tel: 604-532-4654 Media
Contact: Karen Cook-Boas, 604 739-7500, AnorMED Inc. - Financial
Highlights Fourth Quarter Report - 2006 CONSOLIDATED BALANCE SHEETS
(In thousands of Canadian dollars, As at As at except share
numbers) March 31 March 31
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(audited) 2006 2005
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ASSETS Current assets Cash and cash equivalents $ 56,758 $ 57,834
Short-term investments 5,492 7,440 Accounts receivable 504 513
Prepaid expenses 1,353 1,001 Current portion of security deposit
100 - ------------------------- 64,207 66,788 Security deposit -
100 Long-term investment 282 292 Property and equipment, net 3,679
3,040 ------------ ------------ $ 68,168 $ 70,220 ------------
------------ ------------ ------------ LIABILITIES AND
SHAREHOLDERS' EQUITY Current liabilities Accounts payable and
accrued liabilities $ 9,034 $ 4,709 Shareholders' equity Share
capital Issued and outstanding: Common shares - 41,229,405 187,683
153,786 (March 31, 2005 - 31,829,493) Additional paid-in capital
2,891 1,698 Accumulated deficit (131,440) (89,973) ------------
------------ 59,134 65,511 ------------ ------------ $ 68,168 $
70,220 ------------ ------------ ------------ ------------
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands of Canadian
dollars, except For the three months ended For the year ended per
share amounts) March 31 March 31
-----------------------------------------------
------------------------- 2006 2005 2006 2005
-----------------------------------------------
------------------------- (unaudited) (unaudited) (audited)
(audited) Revenue Licensing $ 270 $ 347 $ 295 $ 24,268 Expenses
Research and development 9,501 6,100 32,227 19,561 General and
administrative 3,870 2,028 10,057 6,731 Amortization 236 218 881
886 ------------ ------------ ------------ ------------ 13,607
8,346 43,165 27,178 ------------ ------------ ------------
------------ Other income (expense) Interest and other income 606
431 1,846 1,463 Foreign exchange gain (loss) (53) 156 (443) 262
Other expenses - (207) - (984) ------------ ------------
------------ ------------ 553 380 1,403 741 ------------
------------ ------------ ------------ Net loss $ (12,784) $
(7,619) $ (41,467) $ (2,169) ------------ ------------ ------------
------------ ------------ ------------ ------------ ------------
Loss per common share $ (0.32) $ (0.24) $ (1.20) $ (0.07) Diluted
loss per common share $ (0.32) $ (0.24) $ (1.20) $ (0.07)
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (In
thousands of Canadian dollars, Total except share Common Shares
Additional share- numbers) ---------------------- Accumulated
paid-in holders' (unaudited) Number Amount deficit capital equity
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Balance at March 31, 2005 31,829,493 $ 153,786 $ (89,973) $ 1,698 $
65,511 Issued for cash 14,800 51 - - 51 Issued on exercise of
options 1,399 7 - (3) 4 Stock-based compen- sation - - - 333 333
Net loss - - (8,025) - (8,025)
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Balance at June 30, 2005 31,845,692 153,844 (97,998) 2,028 57,874
Issued for cash 1,000 3 - - 3 Issued on exercise of options 24,000
58 - - 58 Stock-based compen- sation - - - 305 305 Net loss - -
(9,255) - (9,255)
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Balance at Sept- ember 30, 2005 31,870,692 153,905 (107,253) 2,333
48,985 Issued for cash 16,500 55 - - 55 Issued on exercise of
options 13,300 42 - (9) 33 Issued for cash pursuant to public
financing 8,625,000 34,500 - - 34,500 Share issue costs - (2,503) -
- (2,503) Stock-based compen- sation - - - 318 318 Net loss - -
(11,403) - (11,403)
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Balance at Decem- ber 31, 2005 40,525,492 185,999 (118,656) 2,642
69,985 Issued for cash 4,650 22 - - 22 Issued on exercise of
options 699,263 1,662 - (21) 1,641 Stock-based compen- sation - - -
270 270 Net loss - - (12,784) - (12,784)
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Balance at March 31, 2006 41,229,405 $ 187,683 $ (131,440) $ 2,891
$ 59,134
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Total Common Shares Additional share- ----------------------
Accumulated paid-in holders' Number Amount deficit capital equity
-------------------------------------------------------------------------
Balance at March 31, 2004 31,740,148 $ 153,452 $ (87,804) $ 401 $
66,049 Issued for cash 450 3 - - 3 Issued on exercise of options
15,800 66 - (15) 51 Stock-based compen- sation - - - 230 230 Net
loss - - (3,814) - (3,814)
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Balance at June 30, 2004 31,756,398 153,521 (91,618) 616 62,519
Issued for cash 10,860 48 - - 48 Issued on exercise of options
45,498 144 - (3) 141 Stock-based compen- sation - - - 374 374 Net
loss - - (6,584) - (6,584)
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Balance at Sept- ember 30, 2004 31,812,756 153,713 (98,202) 987
56,498 Issued for cash 1,600 10 - - 10 Issued on exercise of
options 9,597 41 - (4) 37 Stock-based compen- sation - - - 349 349
Net income - - 15,848 - 15,848
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Balance at Decem- ber 31, 2004 31,823,953 153,764 (82,354) 1,332
72,742 Issued for cash 4,540 20 - - 20 Issued on exercise of
options 1,000 2 - - 2 Stock-based compen- sation - - - 366 366 Net
loss - - - (7,619) (7,619)
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Balance at March 31, 2005 31,829,493 $ 153,786 $ (89,973) $ 1,698 $
65,511
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CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands of For the
three months ended For the year ended Canadian dollars) March 31
March 31 -----------------------------------------------
------------------------- 2006 2005 2006 2005
-----------------------------------------------
------------------------- (unaudited) (unaudited) (audited)
(audited) Cash provided by (used in): Operations: Net loss $
(12,784) $ (7,619) $ (41,467) $ (2,169) Items not involving cash
Amortization 236 218 881 886 Loss on disposal of property and
equipment 23 7 56 14 Licensing revenue received in shares - - -
(1,312) Unrealized foreign exchange loss (gain) on long-term
investment (1) (10) 10 36 Loss on revaluation of long-term
investment - 207 - 984 Compensatory stock options 270 366 1,226
1,319 Changes in non-cash operating working capital Accounts
receivable (103) (182) 9 (161) Prepaid expenses 147 118 (352) (436)
Accounts payable and accrued liabilities 1,299 2,375 4,325 1,041
------------ ------------ ------------ ------------ (10,913)
(4,520) (35,312) 202 ------------ ------------ ------------
------------ Investments: Net sale (purchase) of short-term
investments (22) 19,375 1,948 17,572 Security deposit - 150 - 150
Proceeds on disposal of property and equipment 2 4 18 4 Purchase of
property and equipment (607) (424) (1,594) (1,014) ------------
------------ ------------ ------------ (627) 19,105 372 16,712
------------ ------------ ------------ ------------ Financing:
Issuance of shares, net of share issue costs 1,663 22 33,864 312
------------ ------------ ------------ ------------ Increase
(decrease) in cash and cash equivalents (9,877) 14,607 (1,076)
17,226 Cash and cash equivalents, beginning of the period 66,635
43,227 57,834 40,608 ------------ ------------ ------------
------------ Cash and cash equivalents, end of the period $ 56,758
$ 57,834 $ 56,758 $ 57,834 ------------ ------------ ------------
------------ ------------ ------------ ------------ ------------
DATASOURCE: AnorMED Inc. CONTACT: Company Contact: W.J. (Bill)
Adams, Chief Financial Officer, Tel: (604) 530-1057 or Kim Nelson,
Manager Investor Relations, Tel: (604) 532-4654; Media Contact:
Karen Cook-Boas, (604) 739-7500,
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