Tekmira Pharmaceuticals Corporation Announces Third Quarter 2009 Operating Results and Provides Corporate Update
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VANCOUVER, BRITISH COLUMBIA, Nov 12 (MARKET WIRE) --
Tekmira Pharmaceuticals Corporation (TSX: TKM), a leading developer of
RNA interference (RNAi) therapeutics and proprietary delivery technology,
announced today its operating results for the third quarter of 2009.
Dr. Mark J. Murray, Tekmira's President and CEO, said, "We made
significant progress on all aspects of our business during the third
quarter of 2009, including the advancement of our two lead product
candidates. We continued to earn significant revenue from our
pharmaceutical partners who are advancing products enabled by our leading
RNAi delivery technology while we remain focused on conservatively
managing our expenses. Consequently, we have extended our cash resources
into the second half of 2011."
"We are on track to release data from our ongoing Phase 1 human clinical
trial for our lead product ApoB SNALP in the first quarter of 2010 and we
expect to advance our second product candidate PLK1 SNALP into human
clinical trials in the second half of 2010. Additionally, both Alnylam
Pharmaceuticals and Roche are advancing products using our SNALP delivery
technology," said Dr. Murray.
Key achievements during the third quarter of 2009 include:
- Continuation of patient enrolment in the Phase 1 human clinical trial
for ApoB SNALP, Tekmira's lead RNAi therapeutic product candidate. ApoB
SNALP is being developed as a treatment for patients with high
low-density lipoprotein (LDL) cholesterol, or "bad" cholesterol, who are
not well served by current therapy. ApoB SNALP is designed to reduce the
production of apolipoprotein B (ApoB), a protein produced in the liver
that plays a central role in cholesterol transport and metabolism. The
Phase 1 clinical trial will evaluate the safety, tolerability and
pharmacokinetics of escalating single doses of ApoB SNALP in
approximately 30 patients with high levels of LDL cholesterol. The trial
may also provide preliminary data on the ability of ApoB SNALP to lower
serum LDL cholesterol levels. Patients whose LDL cholesterol is reduced
by greater than 15% from baseline will be followed until their LDL
cholesterol levels return to baseline. Tekmira expects to complete the
trial and release data in the first quarter of 2010.
- Progress on the company's objective to file an investigational new drug
(IND) application for PLK1 SNALP in 2010 and develop the product
candidate as a treatment for cancer. Tekmira scientists have developed
SNALP formulations directed at liver cancer and distal tumors outside the
liver that result in significant inhibition of tumor growth and prolonged
survival of treated animals. Importantly, PLK1 SNALP was well tolerated
and the efficacy results were confirmed to be the result of silencing
PLK1 via RNA interference.
- Continued execution of the company's partnership with Alnylam
Pharmaceuticals, Inc. (NASDAQ: ALNY). The Alnylam collaboration includes
milestone payments to Tekmira of US$16 million on each RNAi therapeutic
advanced by Alnylam (or its partners) that utilizes the company's
technology, as well as royalties on product sales, and a minimum of $11.2
million in payments to Tekmira for manufacturing services over the next
three years. The first product candidate developed by Alnylam under this
agreement, ALN-VSP, is now in a Phase 1 human clinical trial and a second
product candidate, ALN-TTR, will be entering human clinical trials in
early 2010.
- Continued execution of the company's product development partnership
with global healthcare company Roche (SWX: ROG.VX; RO.S, OTCQX: RHHBY).
The Roche partnership includes payments to Tekmira of up to US$18.4
million to support preclinical development of Roche's first two RNAi
products that use Tekmira's SNALP technology and milestone payments of up
to US$32 million, plus royalties on product sales. Roche expects to file
an IND application for their first SNALP product in 2010.
- Concluding the third quarter with $26.9 million in cash through prudent
management of expenses and strong recurring revenue from Tekmira's
product development partners. Tekmira expects the current cash on hand
will enable execution of its business strategy into the second half 2011
without the need for additional financing.
FINANCIAL RESULTS
For the nine months ended September 30, 2009, the company's net loss was
$7.2 million ($0.14 per common share) as compared to a net loss of $11.3
million ($0.26 per common share) for the comparative period of 2008. For
the three months ended September 30, 2009, Tekmira's net loss was $2.8
million ($0.05 per common share) as compared to a net loss of $6.0
million ($0.12 per common share) for the third quarter of 2008.
There are a number of factors contributing to changes in the company's
results including some unusual 2008 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 $3.3 million for Q3 2009 as compared to $4.2
million for Q3 2008 and was $9.9 million for the first nine months of
2009 as compared to $8.6 million for the first nine months of 2008.
Looking at collaborations revenue, the expiration of the company's
research collaboration with Alnylam in the current quarter has been
offset by expansion of manufacturing services provided to Alnylam and the
expansion of Tekmira's collaboration with Roche. Licensing fees and
milestone payments revenue is lower in 2009 as compared to 2008 as
up-front payments from Alnylam were fully amortized into revenue by the
end of 2008 and the only 2009 receipt was an Alnylam milestone payment of
$0.6 million.
Alnylam revenue
Research and development collaborations revenue from Alnylam was $2.2
million for Q3 2009 as compared to $2.7 million for Q3 2008 and was $6.8
million for the first nine months of 2009 as compared to $4.5 million for
the first nine months of 2008. Under an agreement with Alnylam they were
required to make collaborative research payments at a minimum rate of
US$2.0 million per annum for the provision of Tekmira research staff.
This agreement expired on August 13, 2009 and the company no longer
receives research funding from Alnylam. The company is, however,
continuing to make SNALP research batches for Alnylam under a
Manufacturing Agreement.
Under the Alnylam Manufacturing Agreement the company is the exclusive
manufacturer of any products required by Alnylam that utilize Tekmira
technology through to the end of Phase 2 clinical trials. Under the
Alnylam Manufacturing Agreement there is a contractual minimum payment
for the provision of staff in each of the three years from 2009 to 2011
and Alnylam is reimbursing Tekmira for any external costs incurred.
Revenue from external costs related to the Alnylam Manufacturing
Agreement is being recorded in the period that Alnylam is invoiced for
those costs except where Tekmira bears the risk of batch failure in which
case revenue is recognized only once Alnylam accepts the batch. The total
payment for the provision of staff from 2009 to 2011 is a minimum of
$11.2 million. The company is recognizing revenue for the provision of
staff under the Alnylam Manufacturing Agreement based on actual staff
hours provided and an estimate of total staff hours to be provided in the
year. In the third quarter of 2009 the estimate of total hours to be
provided in the year was reduced to below the minimum that Alnylam must
pay for which resulted in additional revenue being recognized in the
third quarter.
Tekmira is eligible to receive up to US$16.0 million in milestones for
each RNAi therapeutic advanced by Alnylam or its partners that utilizes
Tekmira's intellectual property, and royalties on product sales. On April
3, 2009 Alnylam announced that they had initiated a Phase 1 human
clinical trial for ALN-VSP, a product candidate that utilizes Tekmira's
SNALP technology. The initiation of the ALN-VSP Phase 1 clinical trial
triggered a milestone payment of $0.6 million (US$0.5 million) that was
received and recorded as revenue in Q2 2009.
Roche revenue
Research and development collaborations revenue from Roche was $1.0
million for Q3 2009 as compared to $0.1 million for Q3 2008 and was $2.3
million for the first nine months of 2009 as compared to $0.1 million for
the first nine months of 2008. Under the Roche Product Development
Agreement dated May 2009 Roche pays for the provision of Tekmira staff
and for certain external costs incurred. The company is recognizing
revenue from the Roche Product Development Agreement in proportion to the
services provided up to the reporting date by comparing actual hours
spent to estimated total hours for each project under the contract.
Revenue from external costs incurred on Roche product candidates is being
recorded in the period that Roche is invoiced for those costs.
Tekmira received $0.8 million (US$0.8 million) during Q2 2009 under a
separate Roche Research Agreement. Work under the Roche Research
Agreement was completed in the first half of 2009 and the payment was
recognized as research and development collaborations revenue during that
period.
Expenses - Research, development and collaborations
Research and development expenses decreased to $4.4 million for Q3 2009
as compared to $5.4 million for Q3 2008 and decreased to $12.4 million
for the first nine months of 2009 as compared to $13.1 million for the
first nine months of 2008. As a result of the business combination with
Protiva completed on May 30, 2008, the level and cost of research and
development activities increased. Also, intellectual property portfolio
and related expenses expanded. However, in the first nine months of 2008
research and development expenses were unusually high due to two
compensation related charges. Firstly, stock based compensation for
research and development staff was $0.2 million for the first nine months
of 2009 as compared to $1.6 million for the first nine months of 2008 as
early in 2008 Tekmira's Board approved the accelerated vesting of all
Tekmira stock options concurrent with the announcement of the business
combination with Protiva. Secondly, at the time of the business
combination, Tekmira accrued $2.0 million for payments due to its former
CEO and this was allocated in Q2 2008 as 75% research and development
expenses and 25% general and administrative expenses. There is no
equivalent expense in 2009. Research and development staff numbers have
decreased to 64 at September 30, 2009 (total staff 75) as compared to 78
(total staff 94) at September 30, 2008. In October 2008 we reduced our
workforce by 15 employees as part of the integration of the operations of
Tekmira and Protiva.
Expenses - General and administrative
General and administrative expenses decreased to $0.9 million for Q3 2009
as compared to $1.1 million for Q3 2008 and decreased to $3.0 million for
the first nine months of 2009 as compared to $3.6 million for the first
nine months of 2008. Base line general and administrative costs have
increased due to the greater size of the organization following the
business combination. However, general and administrative expenses were
unusually high in the first nine months of 2008 due to the two
compensation related charges discussed in the research, development and
collaborations expenses section above.
Liquidity and capital resources
At September 30, 2009, the company had cash, cash equivalents and
short-term investments of approximately $26.9 million as compared to
$31.9 million at December 31, 2008.
In the 2008 Annual Report the company provided guidance that there were
sufficient funds on hand to continue product development until some time
in the second half of 2010. As a result of signing the Roche Product
Development Agreement Tekmira now believes that current funds on hand
plus expected interest income and the contractually payable further funds
from collaborations will be sufficient to continue product development
until the second half of 2011 (see Forward-Looking Statements for a
discussion of assumptions made in arriving at this estimate).
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.
More particularly and without limitation, this press release contains
forward-looking statements, assumptions and information concerning the
company's potential, the potential of RNAi therapeutics as a treatment
for disease, product development plans, the number and timing of
advancement of products into clinical development, the plans of
collaborative partners and the impact of those collaborations on product
development activities and financial resources. There are circumstances
and factors that may cause assessments included in these forward-looking
statements to materially change. Such circumstances and factors include
the failure of RNAi therapies to become commercially viable, Tekmira's
inability or a collaborative partner's inability to develop commercially
viable RNAi therapies and changes to the product development plans of
collaboration partners.
Also included in this press release is an estimate of the length of time
that Tekmira's business will be funded by its anticipated financial
resources. There are circumstances and factors that may cause actual cash
usage to be materially different from Tekmira's current estimate of the
adequacy of its cash resources. Such circumstances and factors include
the following: preclinical trials may not be completed, or clinical
trials started, when anticipated; preclinical and clinical trials may be
more costly or take longer to complete than currently anticipated;
preclinical or clinical trials may not generate results that warrant
future development of the tested drug candidate; funding and milestone
payments from research and product development partners may not be
provided when required under agreements with those partners; decisions to
in-license or acquire additional products for development; Tekmira may
become subject to product liability or other legal claims for which the
company has made no accrual in its financial statements; the sufficiency
of budgeted capital expenditures in carrying out planned activities; and
the availability and cost of labour and services.
With respect to the timing of the ApoB SNALP clinical trial discussed in
this news release, there are circumstances that may cause the completion
of the trial to be different than the time periods currently anticipated.
These factors include delays in completing patient enrolment and the
occurrence of adverse events. In addition, clinical trials may not
demonstrate safety and efficacy in humans or the drug candidates may fail
in development or be delayed to a point where they do not become
commercially viable. With respect to the pre-clinical results discussed
in this news release, there is no certainty that human clinical results
will be consistent with pre-clinical results.
The business of Tekmira is also subject to other risks and factors that
may cause actual results, events or developments to be materially
different from any future results, events or developments expressed or
implied by any forward-looking statement and information. Such factors
include, among others, the stage of development of Tekmira, lack of
product revenues, additional capital requirements, 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 Annual Information Form dated March 31, 2009
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
Adam Peeler
Investor Contact
416-815-0700 x 225
apeeler@equicomgroup.com
Tekmira Pharmaceuticals Corporation
Ian Mortimer
Executive Vice President and Chief Financial Officer
604-419-3200
Longview Communications Inc.
David Ryan
Media Contact
604-694-6031
dryan@longviewcomms.ca
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