Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics
company, today reported its consolidated financial results for the first
quarter 2012, and company highlights.
"We made significant clinical and business progress this quarter,
including important achievements with our 'Alnylam 5x15' product
development and commercialization strategy. First, we reported very
encouraging clinical data from our Phase I ALN-PCS trial showing
statistically significant and durable reductions of PCSK9 plasma levels
of up to 84% and lowering of LDL cholesterol of up to 50%, in addition
to demonstrating continued improved efficacy and tolerability for
Alnylam's second-generation lipid nanoparticle delivery technology.
Further, we initiated dosing in our Phase I clinical trial with
ALN-TTR02, an RNAi therapeutic targeting the transthyretin gene for the
treatment of transthyretin-mediated amyloidosis, which also utilizes our
second-generation lipid nanoparticle delivery technology. We are on
track to report clinical data from this study in the third quarter of
this year," said John Maraganore, Ph.D., Chief Executive Officer of
Alnylam. "These important accomplishments, combined with the recent
strengthening of our balance sheet, gives us great confidence in the
continued execution of our 'Alnylam 5x15' product strategy, focused on
advancement of RNAi therapeutics for the treatment of genetically
defined targets for diseases where there are limited treatment options
for patients and caregivers."
"With clear evidence from our ALN-TTR and ALN-PCS Phase I clinical
trials that the RNAi pathway can be harnessed as a therapeutic strategy,
we continue to focus on our 'Alnylam 5x15' efforts with what we believe
to be our highest value opportunities, driving key programs toward
pivotal trials," said Barry Greene, President and Chief Operating
Officer of Alnylam. "This includes accelerated clinical development
plans for ALN-TTR02, which we believe has the potential to become the
leading innovative medicine for the treatment of transthyretin-mediated
amyloidosis, a devastating and debilitating orphan disease. It also
includes our RNAi therapeutic for the treatment of hemophilia, which we
believe represents an exciting opportunity that could fundamentally
change the management of this inherited orphan bleeding disorder. In
addition, we plan to continue to advance additional programs with
existing partners and new alliances we intend to form."
Cash, Cash Equivalents and Total Marketable Securities
At March 31, 2012, Alnylam had cash, cash equivalents and total
marketable securities of $316.9 million, as compared to $260.8 million
at December 31, 2011. In February 2012, Alnylam sold an aggregate of
8,625,000 shares of its common stock through an underwritten public
offering at a price to the public of $10.75 per share. As a result of
the offering, Alnylam received aggregate net proceeds of approximately
$87 million, after deducting underwriting discounts and commissions and
other estimated offering expenses of approximately $5.9 million.
Net Loss
The net loss according to accounting principles generally accepted in
the U.S. (GAAP) for the first quarter of 2012 was $11.4 million, or
$0.25 per share on both a basic and diluted basis (including $3.2
million, or $0.07 per share of non-cash stock-based compensation
expense), as compared to a net loss of $16.3 million, or $0.38 per share
on both a basic and diluted basis (including $4.1 million, or $0.10 per
share of non-cash stock-based compensation expense), for the same period
in the previous year.
Revenues
Revenues were $20.6 million for the first quarter of 2012, as compared
to $20.9 million for the first quarter of 2011. Revenues for the first
quarter of 2012 included $14.0 million of collaboration revenues related
to the company's alliance with Roche (which assigned its rights and
obligations to Arrowhead Research Corporation during 2011), $5.5 million
of revenues from the company's alliance with Takeda Pharmaceuticals
Company Limited, and $1.1 million of expense reimbursement,
amortization, and/or license fee revenues from Cubist Pharmaceuticals,
Inc., InterfeRx(TM), research reagent and services licensees, and other
sources.
Research and Development Expenses
Research and development (R&D) expenses were $21.1 million in the first
quarter of 2012, which included $2.1 million of non-cash stock-based
compensation, as compared to $26.3 million in the first quarter of 2011,
which included $2.7 million of non-cash stock-based compensation. The
decrease in R&D expenses in the first quarter of 2012 as compared to the
prior year period was due primarily to lower clinical trial and
manufacturing costs related to our ALN-RSV and ALN-VSP programs,
partially offset by additional clinical expenses related to the
advancement of our ALN-TTR program. Lab supplies and materials and
compensation and related expenses also decreased due primarily to the
reduction in workforce in connection with our January 2012 strategic
corporate restructuring. Partially offsetting these decreases was a
one-time charge of $3.9 million related to the restructuring, including
employee severance, benefits and related costs.
General and Administrative Expenses
General and administrative (G&A) expenses were $10.4 million in the
first quarter of 2012, which included $1.1 million of non-cash
stock-based compensation, as compared to $10.2 million in the first
quarter of 2011, which included $1.5 million of non-cash stock-based
compensation.
Regulus Therapeutics
Equity in loss of joint venture was $0.9 million and $1.1 million for
the first quarter of 2012 and 2011, respectively, related to our share
of the net losses incurred by Regulus.
Interest Income
Interest income was $0.2 million for the first quarter of 2012, as
compared to $0.4 million for the first quarter of 2011. The decrease in
interest income was due primarily to lower average cash, cash
equivalents and total marketable securities balances as compared to the
prior year.
2012 Financial Guidance
Alnylam expects that its cash, cash equivalents and total marketable
securities balance will be greater than $250 million at December 31,
2012.
"Alnylam further strengthened its balance sheet this quarter with a
public offering of 8.6 million shares of common stock that resulted in
net proceeds of approximately $87 million. This financing, combined with
our recent corporate restructuring that included an approximate 33%
reduction in workforce, results in a balance sheet and operating plan
that we believe will enable us to advance our 'Alnylam 5x15' product
strategy," said Michael Mason, Vice President, Finance and Treasurer of
Alnylam. "We ended this quarter with approximately $317 million in cash,
and expect to end 2012 with greater than $250 million."
First Quarter 2012 and Recent Significant Corporate Highlights
Key "Alnylam 5x15" Program Highlights