UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 7, 2015
Alnylam
Pharmaceuticals, Inc.
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(Exact
Name of Registrant as Specified in Charter)
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Delaware
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001-36407
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77-0602661
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File
Number)
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(IRS Employer
Identification No.)
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300
Third Street, Cambridge, MA
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02142
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (617) 551-8200
Not applicable
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(Former Name or Former Address, if Changed Since Last Report)
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Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2.
below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On May 7, 2015, Alnylam Pharmaceuticals, Inc. announced its financial
results for the quarter ended March 31, 2015. The full text of the
press release issued in connection with the announcement is furnished as
Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be
deemed "filed" for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the "Exchange Act"), or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except as expressly set forth by specific reference in
such a filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
The following exhibit relating to Item 2.02 shall be deemed to be
furnished, and not filed:
99.1 Press Release dated May 7, 2015.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: May 7, 2015
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ALNYLAM
PHARMACEUTICALS, INC.
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By:
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/s/ Michael P. Mason
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Michael P. Mason
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Vice President, Finance and Treasurer
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EXHIBIT INDEX
Exhibit No.
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Description
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99.1
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Press Release dated May 7, 2015
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Exhibit 99.1
Alnylam
Pharmaceuticals Reports First Quarter 2015 Financial Results and
Highlights Recent Period Progress
–
Launched “Alnylam 2020” Guidance for Advancement and Commercialization
of RNAi Therapeutics –
–
Advanced Multiple Clinical Programs and Presented Evidence for Potential
Disease-Modifying Activity for Patisiran in Familial Amyloidotic
Polyneuropathy (FAP) and ALN-AT3 in Hemophilia –
–
Plans to Present New Clinical Data for ALN-AT3 and Initial Clinical Data
for ALN-CC5 in Oral Presentations at Medical Meetings in June –
–
Maintained Strong Balance Sheet with $1.45 Billion in Cash and Expects
to End 2015 with Greater than $1.2 Billion in Cash –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 7, 2015--Alnylam Pharmaceuticals,
Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today reported
its consolidated financial results for the first quarter 2015, and
highlighted recent progress in advancing its pipeline.
“These are exciting times for RNAi therapeutics and Alnylam’s efforts to
bring innovative medicines to patients. With our ‘Alnylam 2020’ strategy
we aim to transition from a late-stage clinical development company to a
multi-product commercial-stage company with a sustainable development
pipeline – a profile that we believe has rarely been achieved in the
biopharmaceutical industry. Amongst many achievements in the first
quarter and recent period, we reported promising data on potential
disease modifying effects for patisiran in Familial Amyloidotic
Polyneuropathy (FAP) and ALN-AT3 in hemophilia. Specifically, in our
patisiran Phase 2 open-label extension – or ‘OLE’ – study, we generated
what we believe to be continued evidence for a possible halting of
neuropathy progression after the first 12 months of treatment, with drug
administration generally well tolerated out to 17 months. Furthermore,
recent results from our Phase 1 trial with ALN-AT3 provide initial
evidence for potential correction of the hemophilia phenotype with an
encouraging tolerability profile. In aggregate, we believe these results
strengthen the bridge that we are building between RNAi-mediated
knockdown and potential clinical benefit for patients,” said John
Maraganore, Ph.D., Chief Executive Officer of Alnylam. “We have also
continued enrolling subjects in our ALN-PCSsc Phase 1 study, and we
initiated dosing in our Phase 1/2 trial with ALN-CC5. With these
advancements we are now poised for a very data-rich mid-year period,
with confirmed oral presentations of clinical results for ALN-AT3 and
ALN-CC5 in June and initial Phase 1 data for ALN-PCSsc expected in
mid-2015. We look forward to sharing these data in the weeks and months
to come.”
First Quarter 2015 and Recent Significant Corporate Highlights
-
Launched “Alnylam 2020” Guidance for advancement and commercialization
of RNAi Therapeutics. Specifically, by the end of 2020, Alnylam
expects to achieve a company profile with 3 marketed products, as well
as 10 RNAi therapeutic clinical programs – including 4 in late stages
of development – across its 3 Strategic Therapeutic Areas (STArs).
-
Advanced pipeline programs in Genetic Medicine STAr.
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Advanced investigational RNAi therapeutic programs for the
treatment of transthyretin (TTR)-mediated amyloidosis (ATTR
amyloidosis).
-
Continued enrollment in APOLLO Phase 3 study of patisiran in
ATTR amyloidosis patients with Familial Amyloidotic
Polyneuropathy (FAP).
-
Reported positive 12-month clinical data from patisiran Phase
2 open-label extension (OLE) study, showing sustained TTR
knockdown of up to a mean 88% and continued evidence for
potential halting of neuropathy progression. Specifically, a
mean 2.5 point decrease in neuropathy impairment score
(mNIS+7) was observed after 12 months of patisiran
administration, comparing favorably to a 13-18 point increase
in untreated patients with similar baseline characteristics,
as estimated from published historical data sets. Patisiran
was also found to be generally well tolerated out to 17 months
of drug administration.
-
Continued enrollment in ENDEAVOUR Phase 3 study of revusiran
in ATTR amyloidosis patients with Familial Amyloidotic
Cardiomyopathy (FAC).
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Presented complete Phase 2 data with revusiran in patients
with TTR cardiomyopathy, showing tolerability and an up to
98.2% knockdown of serum TTR.
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Continued dosing FAC patients in revusiran Phase 2 OLE study
designed to evaluate the tolerability and clinical activity of
revusiran with long-term dosing for up to two years.
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Presented results from a retrospective natural history study
evaluating disease progression in ATTR amyloidosis patients
with FAC, showing a 140 meter decline in 6 minute walk
distance (6MWD) at 18 months; the change in 6MWD at 18 months
is a co-primary endpoint measure in ENDEAVOUR.
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Advanced ALN-AT3 for the treatment of hemophilia and rare bleeding
disorders (RBD).
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Reported positive initial results from a small number of
subjects in a Phase 1 trial of ALN-AT3, including an up to 70%
knockdown of antithrombin (AT) and initial evidence for the
potential correction of the hemophilia phenotype with an up to
334% increase in thrombin generation and marked improvement in
whole blood clotting.
-
The company announces today that it is transitioning to
once-monthly subcutaneous dose cohorts in its ongoing Phase 1
study.
-
The company also announces today that it has completed its
chronic GLP toxicology studies of ALN-AT3, including a 9-month
study in non-human primates and 6-month studies in rat and
hemophilia A mice, with No Adverse Effect Level (NOAEL) doses
that support further advancement of the program.
-
Published pre-clinical study results in Nature Medicine
documenting safety, efficacy, and durability of ALN-AT3 in
rodent and non-human primate (NHP) models of hemophilia.
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Initiated Phase 1/2 trial with ALN-CC5. The trial is being
conducted initially in normal human volunteers, and then is
expected to move to patients with paroxysmal nocturnal
hemoglobinuria (PNH).
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Advanced pipeline programs in Cardio-Metabolic Disease STAr
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Continued dosing in Phase 1 trial with ALN-PCSsc in normal human
volunteers with elevated LDL-C at baseline.
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The company announces today that it has completed the single
ascending dose (SAD) phase of the study and has initiated the
multi-dose (MD) phase with or without statin co-administration.
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Formed new agreement with Isis Pharmaceuticals, extending the
companies’ decade-long alliance to lead the development and
commercialization of RNA therapeutics.
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Completed successful public offering of common stock, with
concurrent private placements from Genzyme, totaling $567 million
in net proceeds.
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Signed a 295,000 square foot lease with an affiliate of BioMed
Realty for Class A laboratory and office space in Cambridge for
the company’s future corporate headquarters.
-
The company announces today that Cynthia Clayton, Vice President
of Investor Relations and Corporate Communications, will be
transitioning from Alnylam to pursue personal interests. Michael
Mason, Alnylam’s Vice President of Finance, will lead the
company’s investor relations area on an interim basis. The company
has initiated an external search to identify a new person for this
role. Joshua Brodsky, Senior Manager, Investor Relations and
Corporate Communications, will report to Mr. Mason during the
transition period.
“We want to thank Cynthia for her decade-long leadership of Alnylam’s
corporate communications team. We are very sad to see her go, but are
happy that she’ll have a chance to pursue her personal interests,” said
John Maraganore. “In the meanwhile, Mike Mason will assume acting
leadership of our investor relations team while we conduct a search for
Cynthia’s replacement.”
Upcoming Events in Mid-2015
-
Alnylam announces today that it plans to present additional data from
its ALN-AT3 Phase 1 trial in subjects with hemophilia at the
International Society on Thrombosis and Haemostasis (ISTH) 2015
Congress, being held June 20 – 25, 2015 in Toronto, in an oral
presentation on Tuesday, June 23 at 2:30 p.m. ET.
-
The company also announces today that it plans to present initial
single ascending dose (SAD) cohort data from its ALN-CC5 Phase 1/2
trial in normal human volunteers at the 20th Congress of
the European Hematology Association (EHA), being held June 11 – 14,
2015 in Vienna, Austria, in an oral presentation on Sunday, June 14 at
8:45 a.m. Central European Summer Time (2:45 a.m. ET).
-
In addition, during mid-2015, Alnylam plans to:
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Initiate Phase 1 trial with ALN-AS1 in development for the
treatment of hepatic porphyrias
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Present initial data from Phase 1 trial of ALN-PCSsc in
development for the treatment of hypercholesterolemia
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File Clinical Trial Application (CTA) for ALN-AAT in development
for the treatment of alpha-1 antitrypsin (AAT)
deficiency-associated liver disease
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Select Development Candidate (DC) for ALN-GO1 in development for
the treatment of Primary Hyperoxaluria Type 1 (PH1)
“Alnylam continues to maintain a very strong balance sheet, with
approximately $1.45 billion in cash as of the end of the first quarter
of 2015,” said Michael Mason, Vice President, Finance & Treasurer. “Our
cash balance was bolstered in the quarter with net proceeds of
approximately $567 million that resulted from a public offering and
concurrent private placements from Genzyme. This financing resulted in a
balance sheet that allows us to invest in a broad pipeline of RNAi
therapeutics across all three Alnylam STArs, which we believe will
enable us to realize our ‘Alnylam 2020’ goals. As for financial guidance
this year, we remain on track to end 2015 with greater than $1.2 billion
in cash.”
Financials
Cash, Cash Equivalents and Total Marketable Securities
At March 31, 2015, Alnylam had cash, cash equivalents and total
marketable securities of $1.45 billion, as compared to $881.9 million at
December 31, 2014.
In January 2015, Alnylam sold an aggregate of 5,447,368 shares of its
common stock through an underwritten public offering at a price to the
public of $95.00 per share. As a result of the offering, Alnylam
received aggregate net proceeds of $496.4 million.
In January 2015, in connection with our public offering described above,
Genzyme exercised its right under the investor agreement between Alnylam
and Genzyme, to purchase, in concurrent private placements, 744,566
shares of common stock, at the public offering price of $95.00 per
share, resulting in proceeds to Alnylam of $70.7 million.
Under the investor agreement, Genzyme also has the right each January to
purchase a number of shares of Alnylam’s common stock based on the
number of shares issued during the previous year for
compensation-related purposes. Genzyme exercised this right to purchase
196,251 shares of our common stock on January 22, 2015 for approximately
$18.3 million.
The exercise of these rights allowed Genzyme to maintain its current
ownership level of Alnylam common stock of approximately 12%.
Non-GAAP Net Loss
The non-GAAP net loss for the first quarter of 2015 was $50.8 million,
or $0.62 per share on both a basic and diluted basis as compared to a
non-GAAP net loss of $26.3 million, or $0.39 per share on both a basic
and diluted basis for the same period in the previous year. The non-GAAP
net loss for the first quarter of 2014 excludes the $224.7 million
charge to in-process research and development expense for the purchase
of the Sirna RNAi assets from Merck, described below, for which there is
no corresponding expense for the first quarter of 2015.
GAAP Net Loss
The net loss according to accounting principles generally accepted in
the U.S. (GAAP) for the first quarter of 2015 was $50.8 million, or
$0.62 per share on both a basic and diluted basis (including $8.2
million, or $0.10 per share of non-cash stock-based compensation
expense), as compared to a net loss of $250.9 million, or $3.70 per
share on both a basic and diluted basis (including $5.6 million, or
$0.08 per share of non-cash stock-based compensation expense), for the
same period in the previous year.
Revenues
Revenues were $18.5 million for the first quarter of 2015, as compared
to $8.3 million for the first quarter of 2014. Revenues for the first
quarter of 2015 included $5.6 million of revenues from the company’s
collaboration with Monsanto, $5.5 million from the company’s alliance
with Takeda Pharmaceuticals Company Limited, $2.0 million for the
company’s alliance with The Medicines Company, $1.8 million from the
company’s alliance with Genzyme and $3.6 million from research reagent
licenses and other sources. The increase in revenues in the first
quarter of 2015 compared to the first quarter of the previous year was
due primarily to revenue recognized in connection with the September
2014 amendment of our remaining performance obligations under the
Monsanto agreement, as well as services performed in connection with our
performance obligations under agreements with The Medicines Company and
Genzyme. In addition, net revenues from collaborators increased due to
the achievement of certain non-recurring milestones from other sources.
The company expects net revenues from collaborators to decrease during
the remainder of 2015 on a comparative basis due primarily to the
completion of our performance obligations under the Monsanto agreement
in February 2015 and the planned completion of our revenue amortization
under the Takeda agreement in May 2015.
Research and Development Expenses
Research and development (R&D) expenses were $58.0 million in the first
quarter of 2015 which included $5.3 million of non-cash stock-based
compensation, as compared to $43.8 million in the first quarter of 2014,
which included $3.7 million of non-cash stock-based compensation. The
increase in R&D expenses in the first quarter of 2015 as compared to the
first quarter of the prior year was due primarily to additional expenses
related to the significant advancement of certain of our clinical and
pre-clinical programs. In addition, compensation, non-cash stock-based
compensation and related expenses increased during the first quarter of
2015 as compared to the first quarter of 2014 due primarily to a
significant increase in headcount during the period as we expand and
advance our development pipeline. Offsetting these increases was a
decrease in license fees during the first quarter of 2015 as compared to
the first quarter of 2014. The company expects that research and
development expenses will increase for the remainder of 2015.
In-Process Research and Development Expense
In the first quarter of 2014, the company incurred a $224.7 million
charge to in-process research and development expense in connection with
the purchase of the Sirna RNAi assets from Merck. Specifically, at the
closing of the transaction, the company paid Merck $25.0 million in cash
and issued 2,142,037 shares of the company’s common stock. The company
issued an additional 378,007 shares of common stock to Merck upon the
completion of certain technology transfer activities, which was
completed in the second quarter of 2014.
General and Administrative Expenses
General and administrative (G&A) expenses were $12.7 million in the
first quarter of 2015, which included $2.9 million of non-cash
stock-based compensation, as compared to $8.9 million in the first
quarter of 2014, which included $1.9 million of non-cash stock-based
compensation. The increase in G&A expenses in the first quarter of 2015
as compared to the first quarter of the prior year was due primarily to
an increase in consulting and professional services related to an
increase in general business activities. In addition, compensation,
non-cash stock-based compensation and related expense increased during
the first quarter of 2015 as compared to the first quarter of 2014 due
primarily to an increase in headcount during the period as compared to
the prior year period. For the remainder of 2015, the company expects
that general and administrative expenses will remain consistent with the
first quarter of 2015.
Benefit from Income Taxes
The company had a benefit from income taxes of $0.4 million for the
first quarter of 2015 as compared to $17.9 million in the first quarter
of 2014. The decrease was due to the corresponding income tax benefit
associated with the sale of the company’s common stock at execution of
the 2014 Genzyme collaboration. In addition, the company also recorded a
reduced income tax benefit for the increase in the value of the
company’s investment in Regulus that the company carried at fair market
value during the same respective period.
Conference Call Information
Management will provide an update
on the company, discuss first quarter 2015 results, and discuss
expectations for the future via conference call on Thursday, May 7, 2015
at 4:30 p.m. ET. To access the call, please dial 877-312-7507 (domestic)
or 631-813-4828 (international) five minutes prior to the start time and
refer to conference ID 38203671. A replay of the call will be available
beginning at 7:30 p.m. ET on May 7, 2015. To access the replay, please
dial 855-859-2056 (domestic) or 404-537-3406 (international), and refer
to conference ID 38203671.
About RNAi
RNAi (RNA interference) is a revolution in biology,
representing a breakthrough in understanding how genes are turned on and
off in cells, and a completely new approach to drug discovery and
development. Its discovery has been heralded as “a major scientific
breakthrough that happens once every decade or so,” and represents one
of the most promising and rapidly advancing frontiers in biology and
drug discovery today which was awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi is a natural process of gene silencing that
occurs in organisms ranging from plants to mammals. By harnessing the
natural biological process of RNAi occurring in our cells, the creation
of a major new class of medicines, known as RNAi therapeutics, is on the
horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi
and comprise Alnylam's RNAi therapeutic platform, target the cause of
diseases by potently silencing specific mRNAs, thereby preventing
disease-causing proteins from being made. RNAi therapeutics have the
potential to treat disease and help patients in a fundamentally new way.
About GalNAc Conjugates and Enhanced Stabilization Chemistry (ESC)
GalNAc Conjugates
GalNAc-siRNA conjugates are a proprietary
Alnylam delivery platform and are designed to achieve targeted delivery
of RNAi therapeutics to hepatocytes through uptake by the
asialoglycoprotein receptor. Alnylam’s Enhanced Stabilization Chemistry
(ESC) GalNAc-conjugate technology enables subcutaneous dosing with
increased potency, durability, and a wide therapeutic index, and is
being employed in several of Alnylam’s genetic medicine programs,
including programs in clinical development.
About LNP Technology
Alnylam has licenses to Tekmira LNP
intellectual property for use in RNAi therapeutic products using LNP
technology.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical
company developing novel therapeutics based on RNA interference, or
RNAi. The company is leading the translation of RNAi as a new class of
innovative medicines. Alnylam’s pipeline of investigational RNAi
therapeutics is focused in 3 Strategic Therapeutic Areas (STArs):
Genetic Medicines, with a broad pipeline of RNAi therapeutics for the
treatment of rare diseases; Cardio-Metabolic Disease, with a pipeline of
RNAi therapeutics toward genetically validated, liver-expressed disease
targets for unmet needs in cardiovascular and metabolic diseases; and
Hepatic Infectious Disease, with a pipeline of RNAi therapeutics that
address the major global health challenges of hepatic infectious
diseases. In early 2015, Alnylam launched its “Alnylam 2020” guidance
for the advancement and commercialization of RNAi therapeutics as a
whole new class of innovative medicines. Specifically, by the end of
2020, Alnylam expects to achieve a company profile with 3 marketed
products, 10 RNAi therapeutic clinical programs – including 4 in late
stages of development – across its 3 STArs. The company’s demonstrated
commitment to RNAi therapeutics has enabled it to form major alliances
with leading companies including Merck, Medtronic, Novartis, Biogen,
Roche, Takeda, Kyowa Hakko Kirin, Cubist, GlaxoSmithKline, Ascletis,
Monsanto, The Medicines Company, and Genzyme, a Sanofi company. In
addition, Alnylam holds an equity position in Regulus Therapeutics Inc.,
a company focused on discovery, development, and commercialization of
microRNA therapeutics. Alnylam scientists and collaborators have
published their research on RNAi therapeutics in over 200 peer-reviewed
papers, including many in the world’s top scientific journals such as Nature,
Nature Medicine, Nature Biotechnology, Cell, New England Journal of
Medicine, and The Lancet. Founded in 2002, Alnylam maintains
headquarters in Cambridge, Massachusetts. For more information about
Alnylam’s pipeline of investigational RNAi therapeutics, please visit www.alnylam.com.
Alnylam Forward Looking Statements
Various statements in this
release concerning Alnylam’s future expectations, plans and prospects,
including without limitation, Alnylam’s expectations regarding its
“Alnylam 2020” guidance, Alnylam’s views with respect to the potential
for RNAi therapeutics, including patisiran, revusiran, ALN-AT3, ALN-CC5,
ALN-PCSsc, ALN-AS1, ALN-AAT, and ALN-GO1, its expectations with respect
to the timing, execution, and success of its clinical and pre-clinical
trials, the expected timing of regulatory filings, including its plan to
file IND or IND equivalent applications and/or initiate clinical trials
for ALN-AAT and ALN-AS1, its expectations regarding reporting of data
from its clinical and pre-clinical studies, including its studies for
patisiran, revusiran, ALN-AT3, ALN-CC5, and ALN-PCSsc, as well as other
research programs and technologies, its plans regarding
commercialization of RNAi therapeutics, and Alnylam’s expected cash
position as of December 31, 2015, constitute forward-looking statements
for the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by these forward-looking statements as a
result of various important factors, including, without limitation,
Alnylam’s ability to manage operating expenses, Alnylam’s ability to
discover and develop novel drug candidates and delivery approaches,
successfully demonstrate the efficacy and safety of its drug candidates,
the pre-clinical and clinical results for its product candidates, which
may not be replicated or continue to occur in other subjects or in
additional studies or otherwise support further development of product
candidates, actions of regulatory agencies, which may affect the
initiation, timing and progress of clinical trials, obtaining,
maintaining and protecting intellectual property, Alnylam’s ability to
enforce its patents against infringers and defend its patent portfolio
against challenges from third parties, obtaining regulatory approval for
products, competition from others using technology similar to Alnylam’s
and others developing products for similar uses, Alnylam’s ability to
obtain additional funding to support its business activities and
establish and maintain strategic business alliances and new business
initiatives, Alnylam’s dependence on third parties for development,
manufacture, marketing, sales and distribution of products, the outcome
of litigation, and unexpected expenditures, as well as those risks more
fully discussed in the “Risk Factors” filed with Alnylam’s most recent
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) and in other filings that Alnylam makes with the SEC.
In addition, any forward-looking statements represent Alnylam’s views
only as of today and should not be relied upon as representing its views
as of any subsequent date. Alnylam explicitly disclaims any obligation
to update any forward-looking statements.
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Alnylam Pharmaceuticals, Inc.
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Unaudited Condensed Consolidated Statements of Comprehensive Loss
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(In thousands, except per share amounts)
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|
|
|
|
|
|
|
|
|
|
|
|
|
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Three Months Ended
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March 31,
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2015
|
|
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|
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2014
|
|
|
|
|
|
|
|
|
|
|
Net revenues from collaborators
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|
|
|
|
$
|
18,537
|
|
|
|
$
|
8,275
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Research and development (1)
|
|
|
|
|
|
58,035
|
|
|
|
|
43,758
|
|
In-process research and development
|
|
|
|
|
|
—
|
|
|
|
|
224,656
|
|
General and administrative (1)
|
|
|
|
|
|
12,724
|
|
|
|
|
8,925
|
|
Total operating expenses
|
|
|
|
|
|
70,759
|
|
|
|
|
277,339
|
|
Loss from operations
|
|
|
|
|
|
(52,222
|
)
|
|
|
|
(269,064
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
1,014
|
|
|
|
|
333
|
|
Other income (expense)
|
|
|
|
|
|
—
|
|
|
|
|
(82
|
)
|
Total other income
|
|
|
|
|
|
1,014
|
|
|
|
|
251
|
|
Loss before income taxes
|
|
|
|
|
|
(51,208
|
)
|
|
|
|
(268,813
|
)
|
Benefit from income taxes
|
|
|
|
|
|
431
|
|
|
|
|
17,870
|
|
Net loss
|
|
|
|
|
$
|
(50,777
|
)
|
|
|
$
|
(250,943
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per common share - basic and diluted
|
|
|
|
|
$
|
(0.62
|
)
|
|
|
$
|
(3.70
|
)
|
|
|
|
|
|
|
|
|
|
Weighted average common shares used to compute basic and diluted net
loss per common share
|
|
|
|
|
|
82,074
|
|
|
|
|
67,786
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
$
|
(50,777
|
)
|
|
|
$
|
(250,943
|
)
|
Unrealized gain on marketable securities, net of tax
|
|
|
|
|
|
3,622
|
|
|
|
|
5,313
|
|
Comprehensive loss
|
|
|
|
|
$
|
(47,155
|
)
|
|
|
$
|
(245,630
|
)
|
|
|
|
|
|
|
|
|
|
(1) Non-cash stock-based compensation expenses included in operating
expenses are as follows:
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
$
|
5,346
|
|
|
|
$
|
3,681
|
|
General and administrative
|
|
|
|
|
|
2,890
|
|
|
|
|
1,910
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alnylam Pharmaceuticals, Inc.
Unaudited GAAP to Non-GAAP Reconciliation: Net Loss and Net
Loss Per Share
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months
|
|
|
|
|
|
Ended March 31,
|
|
|
|
|
|
2015
|
|
|
2014
|
GAAP net loss
|
|
|
|
|
$
|
(50,777)
|
|
|
|
$
|
(250,943)
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
In-process research and development expense
|
|
|
|
|
—
|
|
|
|
|
224,656
|
Non-GAAP net loss
|
|
|
|
|
$
|
(50,777)
|
|
|
|
$
|
(26,287)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per common share – basic and diluted
|
|
|
|
|
$
|
(0.62)
|
|
|
|
$
|
(3.70)
|
Adjustment (as detailed above)
|
|
|
|
|
—
|
|
|
|
|
|
3.31
|
Non-GAAP net loss per common share – basic and diluted
|
|
|
|
|
$
|
(0.62)
|
|
|
|
$
|
(0.39)
|
|
|
|
|
|
|
|
|
|
|
|
|
Use of Non-GAAP Financial Measures
The company supplements its
condensed consolidated financial statements presented on a GAAP basis by
providing additional measures that are considered “non-GAAP” financial
measures under applicable SEC rules. These non-GAAP financial measures
are not prepared in accordance with generally accepted accounting
principles in the United States (GAAP) and should not be viewed in
isolation or as a substitute for GAAP net loss and basic and diluted net
loss per common share.
The company evaluates items on an individual basis, and considers both
the quantitative and qualitative aspects of the item, including (i) its
size and nature, (ii) whether or not it relates to the company’s ongoing
business operations, and (iii) whether or not the company expects it to
occur as part of its normal business on a regular basis. In the first
quarter of 2014, the company’s Non-GAAP net loss and Non-GAAP loss per
common share – basic and diluted financial measures excludes the
in-process research and development expense of $224.7 million related to
the purchase of the Sirna RNAi assets from Merck. The company believes
that the exclusion of this expense provides management and investors
with supplemental measures of performance that better reflect the
underlying economics of the company’s business. In addition, the company
believes the exclusion of this expense is important in comparing current
results with prior period results and understanding projected operating
performance. Management uses these non-GAAP financial measures to
establish budgets and operational goals and to manage the company’s
business.
|
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
|
|
2015
|
|
|
2014
|
Cash, cash equivalents and total marketable securities
|
|
|
|
|
$
|
1,450,754
|
|
|
$
|
881,929
|
Billed and unbilled collaboration receivables
|
|
|
|
|
|
10,107
|
|
|
|
39,937
|
Prepaid expenses and other current assets
|
|
|
|
|
|
13,206
|
|
|
|
9,739
|
Deferred tax assets
|
|
|
|
|
|
33,667
|
|
|
|
31,667
|
Property and equipment, net
|
|
|
|
|
|
21,166
|
|
|
|
21,740
|
Investment in equity securities of Regulus Therapeutics Inc.
|
|
|
|
|
|
99,890
|
|
|
|
94,583
|
Total assets
|
|
|
|
|
$
|
1,628,790
|
|
|
$
|
1,079,595
|
Accounts payable, accrued expenses and other liabilities
|
|
|
|
|
$
|
31,917
|
|
|
$
|
38,791
|
Deferred tax liabilities
|
|
|
|
|
|
33,667
|
|
|
|
31,667
|
Total deferred revenue
|
|
|
|
|
|
60,665
|
|
|
|
66,854
|
Total deferred rent
|
|
|
|
|
|
6,031
|
|
|
|
6,016
|
Total stockholders’ equity (84.2 million and 77.2 million common shares
issued and outstanding and at March 31, 2015 and December 31, 2014,
respectively)
|
|
|
|
|
|
1,496,510
|
|
|
|
936,267
|
Total liabilities and stockholders' equity
|
|
|
|
|
$
|
1,628,790
|
|
|
$
|
1,079,595
|
|
|
|
|
|
|
|
|
|
|
|
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Alnylam’s Annual Report on Form 10-K which includes the audited
financial statements for the year ended December 31, 2014.
CONTACT:
Alnylam Pharmaceuticals, Inc.
Michael Mason,
617-551-8327
Vice President, Finance and Treasurer
or
Joshua
Brodsky, 617-551-8276
Senior Manager, Investor Relations and
Corporate
Communications
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