Tekmira Pharmaceuticals Reports 2008 Audited Results and Provides Corporate Update
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VANCOUVER, BRITISH COLUMBIA, Mar 24 (MARKET WIRE) --
Tekmira Pharmaceuticals Corporation (TSX: TKM) today reported its 2008
audited operating results, including a summary of 2008 corporate and
product development achievements and an update on objectives for 2009.
Dr. Mark J. Murray, Tekmira's President and CEO, said, "Over the past
year Tekmira has emerged as a leader in the field of RNAi therapeutics as
evidenced by our growing list of partners, the advancement of our
internal RNAi product candidates and our continued scientific
achievements. We expect 2009 to be an important year as we initiate a
Phase 1 clinical trial for ApoB SNALP and our partners advance products
based on our industry leading SNALP technology."
Key achievements in 2008 and recent highlights include:
- Completion of the business combination between Tekmira Pharmaceuticals
Corporation and Protiva Biotherapeutics Inc. that closed May 30, 2008,
creating a well funded industry leader in RNAi therapeutics;
- Equity investments by Alnylam Pharmaceuticals, Inc. and the Roche
Venture Fund that closed May 30, 2008;
- Advancement of ApoB SNALP through preclinical development and
Investigational New Drug (IND) enabling studies as a potential treatment
for high cholesterol;
- Rigorous research and publication of PLK1 SNALP data in the Journal of
Clinical Investigation in February 2009; including preclinical anti-tumor
efficacy supporting the advancement of PLK1 SNALP;
- Supporting Alnylam's IND application for ALN-VSP that utilizes
Tekmira's SNALP technology. ALN-VSP has received United States Food and
Drug Administration (FDA) clearance for initiation of a Phase 1 clinical
trial;
- Providing RNAi and SNALP research and development capabilities to a
growing list of partners and collaborators, including Alnylam, Roche,
Bristol-Myers Squibb, the US Army Medical Research Institute for
Infectious Diseases and the United States National Cancer Institute;
- Signing a three year manufacturing alliance with Alnylam to support
development of products utilizing Tekmira's SNALP technology. The
manufacturing alliance was signed January 2009 and will generate a
minimum of $11.2 million in revenue;
- Continued SNALP technology advances, including improving the
therapeutic index 5-10 fold over current formulations, presented at the
Asia Tides Conference in Tokyo, Japan in February 2009;
- Expansion of the new Tekmira management team with the additions of
Tammy Mullarky as Vice President, Strategic Planning and Business
Development and Dr. Peter Lutwyche as Vice President, Pharmaceutical
Development; and
- Maintaining a strong balance sheet with $31.9 million in cash and
equivalents as at December 31, 2008.
Dr. Murray added, "We believe we have the technology, scientific
expertise, pharmaceutical relationships and product candidates backed by
a strong balance sheet to build on our recent progress to provide strong
returns for shareholders over the coming years."
2009 Corporate Milestones and Update
- Filing of an IND and initiation of a Phase 1 human clinical trial in
the first half of 2009 evaluating ApoB SNALP as a treatment for high LDL
or "bad cholesterol". ApoB SNALP has been shown in preclinical studies to
reduce diet-induced high cholesterol, returning blood cholesterol levels
to normal with a single treatment. Tekmira's approach is to address
elevated LDL cholesterol by targeting ApoB, a protein synthesized in the
liver that plays a central role in transporting cholesterol in the body.
- Advancement of PLK1 SNALP through preclinical development in 2009 to
support the filing of an IND in 2010. The IND filing timeline for PLK1
SNALP is being adjusted to allow time to incorporate newly developed
SNALP formulation improvements as presented at the Asia Tides Conference
in February 2009. These formulation improvements are designed to provide
an improved therapeutic index and thereby extend the utility and
opportunity for PLK1 SNALP. PLK1 SNALP has been shown in preclinical
studies to selectively kill cancer cells, while sparing normal cells in
healthy tissue. PLK1 SNALP is targeted against PLK1 (polo-like kinase 1),
a protein involved in tumor cell proliferation. Inhibition of PLK1
prevents the tumor cell from completing cell division, resulting in cell
cycle arrest and cell death. Recent data published in the peer reviewed
Journal of Clinical Investigation highlighted potent anti-tumor efficacy
in preclinical models of liver cancer and in models of cancer outside the
liver.
- Selection of a third internal RNAi product development candidate.
Tekmira has the right to develop a total of seven siRNA products based on
access to Alnylam's leading intellectual property in the RNAi field, two
of which, ApoB SNALP and PLK1 SNALP, have already been selected.
- Manufacturing of Alnylam's ALN-VSP product candidate that will enter a
Phase 1 clinical trial in first half of 2009 as a treatment for liver
cancer and other solid tumors with liver involvement.
- Collaborating with other leaders in the RNAi field including Alnylam,
Roche, Bristol-Myers Squibb and pharmaceutical and biotechnology
companies evaluating RNAi and SNALP technology. Tekmira will continue to
provide research and development capabilities to pharmaceutical
collaborators as they advance product candidates based on Tekmira's SNALP
technology.
- Tekmira will continue to develop novel SNALP formulations to further
expand the utility of the platform.
- Maintaining a strong cash position. Tekmira estimates its net monthly
cash burn rate for 2009 will be less than $1.5 million per month and
expects its existing cash and revenue from partners will fund the
Company's business until the second half of 2010.
2008 Financial Results
Business combination with Protiva on May 30, 2008
On May 30, 2008, Tekmira completed the acquisition of 100% of the
outstanding shares of Protiva Biotherapeutics, Inc., a privately owned
Canadian company developing lipid nanoparticle delivery technologies for
small interfering RNA (siRNA). Concurrent with the business combination
with Protiva, Tekmira entered into initial research agreements with F.
Hoffman-La Roche Ltd and Hoffman La-Roche Inc. (collectively Roche). Also
concurrent with the business combination, the Company completed a private
placement investment of 2,083,333 newly issued common shares for $5.0
million (US$5.0 million, US$2.40 per share) with Alnylam Pharmaceuticals,
Inc. and a private placement investment of 2,083,333 newly issued common
shares for $5.0 million ($2.40 per share) with a Roche affiliate. Tekmira
believes that the business combination gives it leading scientific
capabilities and intellectual property to deliver RNAi therapeutics using
its lipid nanoparticle delivery technology which it refers to as SNALP
(Stable Nucleic Acid Lipid-Particles).
The Protiva acquisition was accounted for using the purchase method of
accounting. The assets and liabilities of Protiva were included in
Tekmira's consolidated financial statements from May 30, 2008, the date
of acquisition. Total consideration of $31.8 million, including
acquisition costs, was allocated to the assets acquired and liabilities
assumed based on preliminary fair values at the date of acquisition
resulting in medical technology assets of $16.3 million and goodwill of
$3.9 million. In valuing Protiva's medical technology Tekmira assumed
certain future net positive cash flows from products, both internal and
from collaborative relationships, based on this technology. If any of the
assumptions underlying Tekmira's valuation of Protiva's medical
technology should change then Tekmira will conduct an asset impairment
test and may be required to write down the value of this asset.
Results of Operations
For the fiscal year ended December 31, 2008, net loss was $14.3 million
($0.35 per common share, basic and fully diluted) as compared to a net
loss of $2.6 million ($0.11 per common share, basic and fully diluted)
for 2007.
There are a number of factors contributing to changes in Tekmira's
results including the inclusion of Protiva's results from May 30, 2008,
some additional expenses linked to the acquisition of Protiva and an
impairment loss on goodwill.
Revenue
Revenue from research and development collaborations, licensing fees and
milestone payments was $11.7 million in 2008 as compared to $15.8 million
in 2007. In 2008 most of the Company's revenue was from its partnership
with Alnylam whereas in 2007 there was also significant revenue from the
Hana partnership. The business combination with Protiva brought in some
new collaborative partner revenue streams.
Alnylam revenue
During 2007 and 2008 Alnylam reimbursed Tekmira for external costs and
the provision of staff for collaborative research, development and
manufacturing activities.
Tekmira will continue to provide collaborative research services to
Alnylam under a collaborative agreement until August 14, 2009 whereby
Alnylam will fund a minimum of US$2.0 million per annum for the provision
of Tekmira research staff. Under a new Manufacturing Agreement dated
January 2, 2009, Tekmira will continue to be the exclusive manufacturer
of any products required by Alnylam through to the end of phase 2
clinical trials that utilize Tekmira's intellectual property. Alnylam
will pay for the provision of staff and for external costs incurred.
Under the new Manufacturing Agreement there is a contractual minimum of
$11.2 million in payments from Alnylam to Tekmira for the three years
from 2009 to 2011 for the provision of staff.
Under a license agreement Tekmira received an up-front licensing payment
of $9.4 million (US$8.0 million) from Alnylam. Under a license agreement
with the University of British Columbia Tekmira made a milestone payment
of $0.9 million in respect of the up-front payment from Alnylam. The
up-front payment and the milestone payment were deferred and were
amortized on a straight-line basis to revenue and expense respectively to
December 31, 2008, the period over which Tekmira provided research
support under that particular agreement. In December 2008, Alnylam filed
an IND application for ALN-VSP, a product candidate that utilizes
Tekmira's SNALP technology. Tekmira is eligible to receive a milestone
payment from Alnylam upon the dosing of the first patient in an ALN-VSP
phase 1 clinical trial which Alnylam expects to occur in the first half
of 2009.
Other RNAi collaborators
Tekmira has active research agreements with a number of other RNAi
collaborators including Bristol-Myers Squibb Company and Roche. Revenue
under these agreements is being recognized on a percentage completion
basis.
Expenses
Research and development
Research and development expenses increased to $16.1 million in 2008 as
compared to $8.3 million in 2007. Inclusion of Protiva expenses from May
30, 2008, including ApoB SNALP and PLK1 SNALP project expenses and salary
and infrastructure costs accounts for $7.1 million of the increase.
The majority of the increase in research and development external
expenditures relate to the ApoB SNALP program, specifically preclinical
toxicology costs and costs related to the purchase of GMP materials.
Stock based compensation for research and development staff was $1.3
million in 2008 as compared to $0.3 million in 2007 as all Tekmira stock
options vested concurrent with the announcement of the business
combination with Protiva. Intellectual property legal expenses increased
by $0.6 million over the prior year due to the expansion of the Company's
patent portfolio following the business combination with Protiva.
Salary and infrastructure costs also increased as a result of the
business combination with Protiva. Staff numbers initially increased by
about 75% as a result of the business combination although there was a
subsequent post-integration reorganization in October. Internal research
and development staff numbers were 61 at December 31, 2008 (total staff
76) as compared to 39 (total staff 50) at December 31, 2007.
Research and development expenses are expected to increase in 2009 as the
ApoB SNALP program advances through development, the PLK1 SNALP program
is advanced into preclinical toxicology studies and the Company continues
to incur collaboration costs that will be passed through to collaborative
partners.
General and administrative
General and administrative expenses were $4.4 million for 2008 as
compared to $4.4 million for 2007. There were a number of off-setting
changes in the composition of general and administrative expenses.
Protiva expenses from May 30, 2008, the date of business combination,
were $0.7 million. Stock based compensation for general and
administrative staff was $0.4 million in 2008 as compared to $0.1 million
in 2007 and in line with the increase noted above. Legal and professional
fees were substantial in 2007 as the Company worked to complete the
corporate reorganization on April 30, 2007. Legal and professional fees
were similarly higher than normal in the period up to completion of the
business combination with Protiva but these fees have been capitalized as
they are a cost of acquisition of Protiva.
General and administrative expenses are expected to be slightly lower in
2009 than 2008 and 2007, as the past two years have included a number of
one time expenses.
Termination and restructuring expenses
Termination and restructuring expenses were $3.2 million in 2008 and $nil
in 2007. In May 2008, as a condition of closing the business combination
with Protiva, the employment contract of Tekmira's Chief Executive
Officer was terminated and an expense of $2.0 million was recorded. In
October 2008, as part of the integration of the operations of Tekmira and
Protiva, there was a restructuring that resulted in a reduction in
workforce of 15 employees and an expense of $1.2 million.
Impairment loss on goodwill
In response to the recent down-turn in financial markets the Company
carried out a goodwill impairment test as at September 30, 2008. Based on
Tekmira's market capitalization as at September 30, 2008 it was
determined that the fair value of goodwill arising from the acquisition
of Protiva was nil and an impairment loss of $3.9 million, the full value
of goodwill, was recorded in the Consolidated statement of operations and
comprehensive loss.
Foreign exchange and other gains (losses)
Foreign exchange and other gains (losses) showed gains of $2.1 million
for 2008 as compared to losses of $1.0 million for 2007. The foreign
exchange gains in 2008 relate largely to the positive effect on US
denominated cash investments and accounts receivable from the
strengthening of the US dollar as compared to the Canadian dollar. A
weakening US dollar in 2007 had the opposite effect.
Towards the end of 2008 Tekmira converted the majority of its US dollar
cash and cash equivalent holdings into Canadian dollars to reduce its
future exposure to foreign exchange rate fluctuations. However, as a
large portion of revenues and expenses are in US dollars, exchange rate
fluctuations will continue to create gains or losses as the Company
expects to continue holding US denominated cash, cash investments,
accounts receivable and accounts payable.
Liquidity and Capital Resources
At December 31, 2008, Tekmira had cash, cash equivalents and short-term
investments of approximately $31.9 million as compared to $20.9 million
at December 31, 2007.
The Company believes that current funds on hand plus expected interest
income and the contractually payable further funds from Alnylam and other
collaborators will be sufficient to continue product development until
some time in the second half of 2010.
About RNAi and SNALP
RNAi drugs have the potential to treat human diseases by "switching-off"
disease causing genes. The technology, representing one of the most
promising and rapidly advancing frontiers in biology and drug discovery,
was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi drugs,
such as siRNA, require delivery technology to be administered
systemically. In preclinical studies, Tekmira's SNALP (stable nucleic
acid-lipid particles) technology has been shown to be a safe and
effective way to deliver RNAi drugs to disease sites. Tekmira believes it
has a leading intellectual property position in the field of siRNA
delivery.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company
focused on advancing novel RNAi therapeutics and providing its leading
lipid nanoparticle delivery technology to pharmaceutical partners.
Further information about Tekmira can be found at www.tekmirapharm.com.
Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
There are forward-looking statements and information contained herein
that are not based on historical fact, including, without limitation,
statements containing the words "believes", "may", "plans", "will",
"estimate", "continue", "anticipates", "intends", "expects", and similar
expressions, and the negative of such expressions. These statements are
only predictions.
Forward-looking statements and information should be considered
carefully. Undue reliance should not be placed on forward-looking
statements and information as there can be no assurance that the plans,
intentions or expectations upon which they are based will occur. By their
nature, forward-looking statements and information involve numerous
assumptions, known and unknown risks and uncertainties, both general and
specific, which contribute to the possibility that the predictions,
forecasts, projections and other forward-looking statements and
information will not occur and may cause actual results or events to
differ materially from those anticipated in such forward-looking
statements and information.
Within the next several years, Tekmira's believes that substantial
additional funds will be required to continue with the active development
of its pipeline products and technologies. Tekmira's assumption that its
cash resources are sufficient to maintain operations until the second
half of 2010 is based, in particular, on assumptions involving the
following:
- revenues earned from collaborative partnerships, particularly Alnylam;
- decisions to in-license or acquire additional products for development,
in particular for Tekmira's RNAi therapeutics program;
- the extent to which Tekmira continues development or can extract
significant value from its technologies;
- Tekmira's ability to attract and retain corporate partners, and their
effectiveness in carrying out the development and ultimate
commercialization of its product candidates;
- the decisions, and the timing of decisions, made by health regulatory
agencies regarding Tekmira's technology and products;
- competing technological and market developments; and
- prosecuting and enforcing patent claims and other intellectual property
rights.
More particularly and without limitation, this discussion and analysis
contains forward-looking statements and information concerning the
potential of Tekmira; the potential of RNAi therapeutics as a treatment
for disease; and the number and timing of advancement of its products
into clinical development.
There are also other factors that may cause the actual results, events or
developments to be materially different from any future results, events
or developments expressed or implied by such forward-looking statements
and information. Such factors include, among others, the stage of
development of Tekmira, lack of product revenues, additional capital
requirements, the impact of the global economic downturn, the need to
obtain regulatory approval to commence clinical trials, risks associated
with the completion of clinical trials and obtaining regulatory approval
to market Tekmira's products, the safety and efficacy of Tekmira's
products, the ability to protect Tekmira's intellectual property and
dependence on collaborative partners. A more complete discussion of the
risks and uncertainties facing Tekmira appears in Tekmira's management
information circular dated May 1, 2008 available at www.sedar.com.
Tekmira disclaims any obligation to update any such factors or to
publicly announce the result of any revisions to any of the
forward-looking statements or information contained herein to reflect
future results, events or developments, except as required by law.
Contacts:
The Equicom Group - Investors
Adam Peeler
(416) 815-0700 x 225
Email: apeeler@equicomgroup.com
Tekmira Pharmaceuticals Corporation - Investors
Ian Mortimer
Vice President and Chief Financial Officer
(604) 419-3200
Website: www.tekmirapharm.com
Longview Communications Inc. - Media
David Ryan
(604) 694-6031
Email: dryan@longviewcomms.ca
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