– Introduced Pipeline Growth Strategy for RNAi
Therapeutics in Three Strategic Therapeutic Areas, or “STArs,” and
Launched “Alnylam 2020” Guidance for Advancement and
Commercialization of RNAi Therapeutics –
– Presented Positive Data from Multiple
Clinical Programs, Including Initial Evidence of Potential Disease
Modifying Effects with Patisiran and ALN-AT3 –
– Advanced Revusiran into ENDEAVOUR Phase 3
Trial and Added Three New Programs into Clinical Stages –
– Maintained Strong Balance Sheet with $882
Million in Cash and Expects to End 2015 with Greater than $1.2
Billion in Cash –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi
therapeutics company, today reported its consolidated financial
results for the fourth quarter and full year 2014, and highlighted
recent progress in advancing its pipeline.
“Alnylam made excellent progress in the fourth quarter of 2014
and the recent period, as we continued advancing RNAi therapeutics
in clinical studies. Amongst other highlights, we reported clinical
data from our patisiran and ALN-AT3 programs showing what we
believe to be early evidence for the translation of RNAi-mediated
knockdown into potential clinical benefit for patients. We also
executed on our pipeline goals, with strong enrollment in our
patisiran APOLLO Phase 3 study and advancement of revusiran into
our ENDEAVOUR Phase 3 trial. In addition, we filed three Clinical
Trial Applications for ALN-PCSsc, ALN-CC5, and ALN-AS1, and have
initiated Phase 1 studies for two of those programs,” said John
Maraganore, Ph.D., Chief Executive Officer of Alnylam. “Alnylam
also introduced its pipeline growth strategy and new guidance.
Specifically, Alnylam intends to advance its pipeline in three
Strategic Therapeutic Areas, or ‘STArs’ – Genetic Medicines,
Cardio-Metabolic Disease, and Hepatic Infectious Disease – where we
believe there are significant opportunities for RNAi therapeutics
as high impact medicines. Further, with ‘Alnylam 2020’ we have
launched new guidance that marks our expected 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.”
“Alnylam continues to maintain a very strong balance sheet,
ending 2014 with approximately $882 million in cash,”
said Michael Mason, Vice President, Finance & Treasurer.
“We also further strengthened our balance sheet earlier this year
with a public offering and concurrent private placements from
Genzyme that resulted in net proceeds of approximately $567
million. This financing results in a balance sheet that allows us
to invest in a broad pipeline of RNAi therapeutics across all three
STArs, which we believe should enable us to achieve our ‘Alnylam
2020’ guidance. As for financial guidance this year, we expect to
end 2015 with greater than $1.2 billion in cash.”
Fourth Quarter 2014 and Recent Significant Corporate
Highlights
- Introduced pipeline growth strategy for
RNAi therapeutics in three 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 dyslipidemia,
hypertension, non-alcoholic steatohepatitis (NASH), and type 2
diabetes; and Hepatic Infectious Disease, with a pipeline of RNAi
therapeutics that address the major global health challenges of
hepatic infectious diseases.
- Launched “Alnylam 2020” Guidance for
advancement and intended commercialization of RNAi Therapeutics.
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.
- Advanced pipeline programs in Genetic
Medicine STAr.
- Advanced investigational RNAi
therapeutic programs for the treatment of transthyretin
(TTR)-mediated amyloidosis (ATTR).
- Continued enrollment in APOLLO Phase 3
study of patisiran in ATTR patients with Familial Amyloidotic
Polyneuropathy (FAP)
- Reported positive six-month clinical
data from patisiran Phase 2 open-label extension (OLE) study,
showing tolerability, sustained TTR knockdown, and promising
initial evidence for potential stabilization of neuropathy
progression.
- Initiated ENDEAVOUR Phase 3 study with
revusiran. ENDEAVOUR is a randomized, double-blind,
placebo-controlled, global study designed to evaluate the efficacy
and safety of revusiran in ATTR patients with Familial Amyloidotic
Cardiomyopathy (FAC).
- Presented positive initial Phase 2 data
with revusiran, with up to 98.2% knockdown of serum TTR; revusiran
administration was found to be generally well tolerated in patients
with advanced cardiac disease.
- Initiated Phase 2 OLE study with
revusiran to evaluate tolerability and clinical activity with
long-term dosing for up to two years.
- Reported positive initial results from
Phase 1 trial of ALN-AT3, including 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.
- Initiated Phase 1/2 trial with ALN-CC5.
The trial is being conducted initially in normal human volunteers,
and then in patients with paroxysmal nocturnal hemoglobinuria
(PNH).
- Filed Clinical Trial Application (CTA)
to initiate a Phase 1 trial with ALN-AS1 in acute intermittent
porphyria (AIP) patients who are asymptomatic “high excreters”
(ASHE), and then in AIP patients who experience recurrent porphyria
attacks.
- Expanded Genetic Medicine pipeline with
ALN-GO1, an investigational RNAi therapeutic targeting glycolate
oxidase (GO) in development for the treatment of Primary
Hyperoxaluria Type 1 (PH1).
- Advanced pipeline programs in
Cardio-Metabolic Disease STAr
- Initiated Phase 1 trial with ALN-PCSsc
in normal human volunteers with elevated LDL-C at baseline.
- Advanced pipeline programs in Hepatic
Infectious Disease STAr
- Selected Development Candidate (DC) for
ALN-HBV, showing an up to 3.9 log10 knockdown of hepatitis surface
antigen (HBsAg) after a single subcutaneous dose in a rodent model
of HBV infection.
- Expanded Hepatic Infectious Disease
pipeline with ALN-HDV for Hepatitis Delta Virus (HDV) infection and
ALN-PDL for chronic liver infections.
- Formed new agreement with Isis
Pharmaceuticals, extending the companies’ decade-long alliance to
lead the development and commercialization of RNA
therapeutics.
- Completed successful public offering of
common stock, with concurrent private placements from Genzyme,
totaling $567 million in net proceeds.
- Announced changes to Board of Directors
and Management Team
- Alnylam elected Michael W. Bonney to
its Board of Directors.
- Alnylam announces today certain
promotions and appointments, including:
- Akshay Vaishnaw, M.D., Ph.D. to the
position of Executive Vice President of Research & Development
and Chief Medical Officer from the position of Executive Vice
President, Chief Medical Officer.
- Rachel Meyers, Ph.D. to the position of
Senior Vice President of Research from the position of Vice
President of Research & RNAi Lead Development.
- Kevin Fitzgerald, Ph.D. to the position
of Vice President of Research from the position of Senior Director
of Research.
- Pushkal Garg, M.D. to the position of
Senior Vice President, Clinical Development.
- Eric Green to the position of Vice
President, General Manager, TTR Program.
- Marcie Ruddy, M.D. to the position of
Vice President, Drug Safety & Pharmacovigilance.
- In addition, Alnylam announced the
planned departure of Laurence Reid, Ph.D., who held the position of
Senior Vice President, Chief Business Officer.
Upcoming Events in Early and Mid-2015
- Alnylam announces today that it plans
to present 12-month OLE study data with patisiran at the American
Academy of Neurology 67th Annual Meeting, being held April 18 – 25,
2015 in Washington, D.C., in an oral presentation on Tuesday, April
21 at 1:30 p.m. ET.
- The company also announces today that
it plans to present additional clinical results from the Phase 2
trial of revusiran at the American College of Cardiology (ACC) 64th
Annual Scientific Session & Expo, being held March 14 – 16,
2015 in San Diego, California, in a poster presentation on Sunday,
March 15 at 1:30 p.m. PT (4:30 p.m. ET).
- Also at the ACC meeting, Alnylam plans
to present results of a natural history study of patients with TTR
cardiac amyloidosis in a meeting with clinicians from the
Association of Black Cardiologists on Sunday, March 15.
- In addition, during early and mid-2015,
Alnylam plans to:
- Present additional data from Phase 1
trial of ALN-AT3 in development for the treatment of hemophilia and
rare bleeding disorders
- Present initial data from the Phase 1/2
trial of ALN-CC5 in development for the treatment of
complement-mediated diseases
- Initiate Phase 1 trial of ALN-AS1 in
development for the treatment of hepatic porphyrias
- Present initial data from Phase 1 trial
of ALN-PCSsc in development for the treatment of
hypercholesterolemia
- File CTA for ALN-AAT in development for
the treatment of alpha-1 antitrypsin (AAT) deficiency-associated
liver disease
- Select DC for ALN-GO1 in development
for the treatment of PH1
Financials
Cash, Cash Equivalents and Total Marketable Securities
At December 31, 2014, Alnylam had cash, cash equivalents and
total marketable securities of $881.9 million, as compared to
$350.5 million at December 31, 2013.
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 approximately
$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 approximately $70.7 million. The exercise of this right
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 year ended December 31, 2014 was
$139.6 million, or $1.88 per share on both a basic and diluted
basis as compared to a non-GAAP net loss of $89.2 million, or $1.45
per share on both a basic and diluted basis for the prior year. The
non-GAAP net loss for the year ended December 31, 2014 excludes the
$220.8 million charge to in-process research and development
expense in connection with the purchase of the Sirna RNAi assets
from Merck, described below.
GAAP Net Loss
The net loss according to GAAP for the fourth quarter of 2014
was $21.4 million, or $0.28 per share on both a basic and diluted
basis (including $13.4 million, or $0.17 per share of non-cash
stock-based compensation expense), as compared to a net loss of
$32.4 million, or $0.51 per share on both a basic and diluted basis
(including $5.4 million, or $0.09 per share of non-cash stock-based
compensation expense), for the same period in the previous year.
For the year ended December 31, 2014, the net loss was $360.4
million, or $4.85 per share (including $33.1 million, or $0.45 per
share of non-cash stock-based compensation expense), as compared to
a net loss of $89.2 million, or $1.45 per share (including $20.7
million, or $0.34 per share of non-cash stock-based compensation
expense), for the same period in the previous year. The increase in
net loss for the year ended December 31, 2014 compared to the prior
year resulted primarily from a $220.8 million charge to in-process
research and development expense in connection with the purchase of
the Sirna RNAi assets from Merck, described below.
Revenues
Revenues were $24.0 million for the fourth quarter of 2014, as
compared to $10.8 million for the same period last year. Revenues
for the fourth quarter of 2014 included $8.8 million in revenues
from the company’s collaboration with Monsanto, $6.9 million of
revenues related to the company’s collaboration with The Medicines
Company, $5.5 million of revenues from the company’s alliance with
Takeda Pharmaceuticals Company Limited, and $2.8 million of
revenues from research reagent licenses and other sources. Revenues
were $50.6 million for the year ended December 31, 2014, as
compared to $47.2 million for the prior year. Revenues for the year
ended December 31, 2014 included $22.0 million of revenues related
to the company’s collaboration with Takeda, $15.0 million of
revenues related to the company’s collaboration with Monsanto,
$10.8 million of revenues related to the company’s collaboration
with The Medicines Company, and $2.8 million of revenues from
research reagent licenses and other sources.
Research and Development Expenses
Research and development (R&D) expenses were $55.5 million
in the fourth quarter of 2014, which included $8.2 million of
non-cash stock-based compensation, as compared to $32.1 million in
the fourth quarter of 2013, which included $3.3 million of non-cash
stock-based compensation. R&D expenses were $190.2 million for
the year ended December 31, 2014, which included $18.2 million of
non-cash stock-based compensation, as compared to $113.0 million
for the prior year, which included $14.4 million of non-cash
stock-based compensation. The increase in R&D expenses for the
quarter and year ended December 31, 2014 as compared to the prior
year periods was due primarily to additional expenses associated
with the significant advancement of certain of the company’s
clinical and pre-clinical programs. The company expects that
R&D expenses will increase significantly in 2015 as it
continues to advance and expand its pipeline across its three
STArs.
In-Process Research and Development Expense
In 2014, the company incurred a $220.8 million charge to
in-process research and development expense in connection with the
purchase of the Sirna RNAi assets from Merck. In future periods,
there will be no additional charges recorded to in-process research
and development related to this purchase of the Sirna RNAi assets
from Merck.
General and Administrative Expenses
General and administrative (G&A) expenses were $14.2 million
in the fourth quarter of 2014, which included $5.2 million of
non-cash stock-based compensation, as compared to $8.3 million in
the fourth quarter of 2013, which included $2.1 million of non-cash
stock-based compensation. G&A expenses were $44.5 million for
the year ended December 31, 2014, which included $14.8 million of
non-cash stock-based compensation, as compared to $27.2 million in
2013, which included $6.3 million of non-cash stock-based
compensation. G&A expenses for the quarter and year ended
December 31, 2014 as compared to the prior year periods increased
due primarily to an increase in non-cash stock-based compensation
expenses. In addition, consulting and professional services
increased during the year ended December 31, 2014 as compared to
the prior year related to general business activities and certain
professional services. The company expects that G&A expenses
will increase slightly in 2015.
Benefit from (Provision for) Income Taxes
The company had a benefit from income taxes of $22.1 million for
the fourth quarter of 2014 as compared to a provision for income
taxes of $3.0 million for the fourth quarter of 2013. The company’s
benefit from income taxes was $40.2 million for the year ended
December 31, 2014, as compared to $2.7 million for the prior year.
The increase during the quarter and year ended December 31, 2014 as
compared to the prior year periods was due primarily to the
corresponding income tax expense associated with the increase in
the value of our investment in Regulus, as well as the difference
between the value of stock and the cash proceeds received from
Genzyme for the issuance of our common stock. The corresponding
income tax expense has been recorded in other comprehensive income
and additional paid-in capital, respectively.
Investment in Regulus Therapeutics
The company accounts for its investment in Regulus at fair value
by adjusting the value to reflect fluctuations in Regulus’ stock
price each reporting period. At December 31, 2014, the fair market
value of the company’s investment in Regulus was $94.6 million as
compared to $45.5 million at December 31, 2013.
2015 Financial Guidance
Alnylam expects that its cash, cash equivalents, and total
marketable securities balance will be greater than $1.2 billion at
December 31, 2015.
Conference Call InformationManagement will provide an
update on the company, discuss fourth quarter and 2014 results, and
discuss expectations for the future via conference call on
Thursday, February 12, 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 82620462. A replay of the call will
be available beginning at 7:30 p.m. ET on February 12, 2015. To
access the replay, please dial 855-859-2056 (domestic) or
404-537-3406 (international), and refer to conference ID
82620462.
About RNAiRNAi (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 ConjugatesGalNAc-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 TechnologyAlnylam has licenses to Tekmira LNP
intellectual property for use in RNAi therapeutic products using
LNP technology.
About Alnylam PharmaceuticalsAlnylam 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 Idec, 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 StatementsVarious 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, ALN-HBV,
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-AS1 and ALN-AAT, , 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 Quarterly Report on Form 10-Q 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.
ALNYLAM
PHARMACEUTICALS, INC. UNAUDITED CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (In thousands,
except per share amounts) Three Months Ended
December 31,
Year Ended
December 31,
2014 2013 2014
2013 Net revenues from collaborators $
24,019 $ 10,847 $ 50,561 $ 47,167
Operating expenses:
Research and development (1) 55,546 32,106 190,249 112,957
In-process research and development — — 220,766 — General and
administrative (1) 14,185 8,333 44,526
27,152 Total operating expenses 69,731 40,439
455,541 140,109 Loss from operations ( 45,712)
(29,592) (404,980) (92,942)
Other income
(expense): Interest income 780 285 2,559 1,069 Other income
(expense) 1,452 (29) 1,817 (47) Total
other income 2,232 256 4,376
1,022
Loss before income taxes (43,480) (29,336) (400,604) (91,920)
Benefit from (provision for) income taxes 22,091
(3,021) 40,209 2,695 Net loss $ (21,389) $ (32,357) $
(360,395) $ (89,225) Net loss per common share - basic and diluted
$ (0.28) $ (0.51) $ (4.85) $ (1.45) Weighted average common shares
used to compute basic and diluted net loss per common share
76,957 62,909 74,278 61,551
Comprehensive income (loss): Net loss $ (21,389) $ (32,357)
$ (360,395) $ (89,225) Unrealized gain (loss) on marketable
securities, net of tax 35,091 (7,451) 31,127 4,055
Reclassification adjustment for realized
gain on marketable securities included in net loss
(1,514) — (2,081) — Comprehensive
income (loss) $ 12,188 $ (39,808) $ (331,349) $ (85,170)
(1) Non-cash stock-based compensation
expenses included in operating expenses are as follows:
Research and development
$
8,214
$
3,277
$
18,233
$
14,369
General and administrative
5,224
2,129
14,828
6,334
ALNYLAM PHARMACEUTICALS, INC. UNAUDITED
GAAP TO NON-GAAP RECONCILIATION: NET LOSS AND NET LOSS PER
SHARE (In thousands, except per share amounts)
Three Months Ended
December 31,
Year Ended
December 31,
2014 2013 2014
2013 GAAP net loss $ (21,389) $ (32,357) $ (360,395) $
(89,225) Adjustment: In-process research and development —
— 220,766 — Non-GAAP net loss $ (21,389) $
(32,357) $ (139,629) $ (89,225) GAAP net loss per
common share - basic and diluted $ (0.28) $ (0.51) $ (4.85) $
(1.45) Adjustment (as detailed above) — — 2.97
— Non-GAAP net loss per common share - basic and diluted $
(0.28) $ (0.51) $ (1.88) $ (1.45)
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 year ended December 31,
2014, the company’s Non-GAAP net loss and Non-GAAP net loss per
common share – basic and diluted financial measures excludes the
in-process research and development expense of $220.8 million
related to the purchase of the Sirna RNAi assets from Merck. The
company believes that the exclusion of this item 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
item 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)
December
31, December 31, 2014
2013 Cash, cash equivalents and total
marketable securities $ 881,929 $ 350,472 Billed and unbilled
collaboration receivables 39,937 4,248 Prepaid expenses and other
current assets 9,739 3,910 Deferred tax assets 31,667 — Property
and equipment, net 21,740 16,448 Investment in equity securities of
Regulus Therapeutics Inc. 94,583
45,452
Total assets $ 1,079,595
$ 420,530 Accounts payable and accrued
expenses $ 38,791 $ 20,056 Deferred tax liabilities 31,667 — Total
deferred revenue 66,854 126,090 Total deferred rent 6,016 4,037
Total stockholders’ equity (77.2 million and 63.7 million common
shares issued and outstanding and at December 31, 2014 and December
31, 2013, respectively) 936,267
270,347
Total liabilities and stockholders' equity
$ 1,079,595 $ 420,530
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, 2013.
Alnylam Pharmaceuticals, Inc.Cynthia Clayton,
617-551-8207Vice President, Investor Relations and Corporate
CommunicationsorMichael Mason, 617-551-8327Vice President, Finance
and Treasurer
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