– Advanced Pipeline of Eight Clinical Stage
Programs in 2015, with Ten or More Major Clinical Data Readouts,
Start of Fitusiran Phase 3 Trials, and Three New IND Filings
Planned in 2016 –
– Completed Enrollment in Patisiran Phase 3
APOLLO Trial, Positioning the Company for First Filing for
Regulatory Approval in 2017 –
– Maintained Strong Balance Sheet with $1.28
Billion in Cash and Expects to End 2016 with Greater than $850
Million in Cash –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today reported its consolidated financial
results for the fourth quarter and full year 2015, and highlighted
recent progress on its pipeline.
“In 2015, including the fourth quarter, we made strong progress
advancing our pipeline and executing on our broader business
objectives. Through our focused efforts, we grew our pipeline to
eight clinical stage programs, achieved human proof of concept in
multiple programs, and accrued patients in our two pivotal Phase 3
trials, including the APOLLO study, where we have now completed
enrollment,” said John Maraganore, Ph.D., Chief Executive Officer
at Alnylam. “We believe 2016 will be a key year for Alnylam as we
expect ten or more clinical data readouts, the start of two pivotal
Phase 3 trials in our fitusiran hemophilia program, and the filing
of three new INDs. In addition, with our progress in APOLLO, we’re
entering the dawn of our commercial transition with planned
regulatory submissions in 2017 for patisiran approval, if the trial
is positive. We believe our 2016 plans place us firmly on track to
achieve our ‘Alnylam 2020’ goals of building a multi-product,
commercial-stage company with a robust and sustainable pipeline
across our three Strategic Therapeutic Areas, or ‘STArs.’”
Fourth Quarter 2015 and Recent Significant Corporate
Highlights
- Advanced investigational pipeline
programs in Genetic Medicine STAr.
- Advanced RNAi therapeutics programs for
the treatment of transthyrethin (TTR)-mediated amyloidosis (ATTR
amyloidosis).
- Completed APOLLO Phase 3 enrollment
with 225 patients for patisiran, in development for patients with
Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis).
- If the study is positive, the Company
expects to submit a New Drug Application (NDA) and Marketing
Authorisation Application (MAA) for patisiran, based on an analysis
of the full APOLLO data set, in late 2017.
- Reported positive initial 18-month
clinical data from patisiran Phase 2 open-label extension (OLE)
study, showing continued evidence for potential halting of
neuropathy progression. Patisiran was also found to be generally
well tolerated out to nearly two years of drug administration
through the data cutoff date.
- Complete 18-month clinical data from
the patisiran Phase 2 OLE is expected to be reported in an oral
session at the upcoming American Academy of Neurology (AAN) annual
meeting on April 20, 2016, in Vancouver, Canada.
- Continued enrollment in ENDEAVOUR Phase
3 study of revusiran in ATTR amyloidosis patients with Familial
Amyloidotic Cardiomyopathy (FAC), with data expected in 2018.
- Reported initial 6-month clinical data
from revusiran Phase 2 OLE study, showing sustained TTR knockdown
representing the longest dosing experience reported to date for
target gene knockdown with a GalNAc-siRNA conjugate. In majority of
patients, revusiran was generally well tolerated out to 10 months
of administration through the data cutoff date.
- Advanced Development Candidate (DC) for
ALN-TTRsc02, an ESC-GalNAc-siRNA conjugate targeting TTR for the
treatment of ATTR amyloidosis, with goal of filing a Clinical Trial
Application (CTA) in early 2016, starting a Phase 1 study in
mid-2016 with initial data in late 2016, and initiating a Phase 3
trial in 2017.
- Advanced fitusiran (ALN-AT3) for the
treatment of hemophilia and rare bleeding disorders (RBD).
- Presented positive interim data from
ongoing Phase 1 trial of fitusiran.
- Interim results showed that monthly
subcutaneous doses achieved antithrombin (AT) lowering associated
with statistically significant and clinically meaningful increases
in thrombin generation and decreases in bleeding frequency in
patients with hemophilia A and B.
- Fitusiran was also found to be
generally well tolerated through the data cutoff date, including no
clinically significant increases in D-dimer, a biomarker of
excessive clot formation.
- Announced that Sanofi Genzyme elected
to opt into the fitusiran program for development and
commercialization outside of North America and Western Europe,
while retaining its future opt-in right to co-develop and
co-promote fitusiran with Alnylam in North
America and Western Europe, subject to certain
restrictions.
- Advanced ALN-CC5 for the treatment of
complement-mediated diseases.
- Presented positive initial data from an
ongoing Phase 1/2 clinical trial.
- Results showed that ALN-CC5 achieved
clinically meaningful reductions in serum C5 and inhibition of
complement activity.
- ALN-CC5 was also shown to be generally
well tolerated, with no clinically significant, drug-related
adverse events through the data cutoff date.
- Initiated Part C of ongoing Phase 1/2
trial in patients with paroxysmal nocturnal hemoglobinuria
(PNH).
- Advanced ALN-AS1 for the treatment of
acute hepatic porphyrias.
- Alnylam announces today that it has
enrolled its first patient in Part C of the ongoing Phase 1
clinical trial. Part C is being conducted in Acute Intermittent
Porphyria (AIP) patients experiencing multiple recurrent porphyria
attacks, and will evaluate the safety and tolerability of multiple
doses of ALN-AS1 as well as measures of clinical activity,
including reduction in frequency and severity of attack symptoms,
hospitalizations, quality of life, and reduction in the use of heme
and pain medications.
- The Company expects to report initial
data from recurrent attack patients in late 2016 and, if these data
are positive, to initiate a Phase 3 study in 2017.
- Advanced ALN-AAT for the treatment of
alpha-1 antitrypsin (AAT) deficiency-associated liver disease.
- Continued dosing human volunteers in
ongoing Phase 1 study.
- Advanced ALN-GO1 for the treatment of
primary hyperoxaluria type 1 (PH1).
- Filed CTA to initiate Phase 1 study and
obtained approval of the CTA from U.K. regulatory authorities.
- Alnylam announces today that the United
States Food & Drug Administration (FDA) has granted Orphan Drug
Designation to ALN-GO1 for the treatment of PH1.
- Advanced investigational pipeline
programs in Cardio-Metabolic Disease STAr.
- Advanced ALN-PCSsc for the treatment of
hypercholesterolemia.
- Presented positive interim Phase 1
clinical data demonstrating PCSK9 knockdown and LDL-cholesterol
lowering supportive of a potential bi-annual subcutaneous dose
regimen.
- The Medicines Company initiated the
Phase 2 ORION-1 trial for ALN-PCSsc. The trial is expected to
recruit 480 patients with atherosclerotic cardiovascular disease
(ASCVD) and elevated LDL-C.
- Advanced investigational pipeline
programs in Hepatic Infectious Disease STAr.
- Completed pre-clinical, IND-enabling
studies with ALN-HBV supporting a CTA filing expected in early
2016.
- Alnylam announces today that in
February 2016, Sanofi Genzyme exercised its right under the
investor agreement between Alnylam and Sanofi Genzyme to purchase
205,030 shares of Alnylam’s common stock based on the number of
shares Alnylam issued for 2015 compensation-related purposes, at
$69.75 per share, resulting in proceeds to Alnylam of $14.3
million.
- The exercise of this right allowed
Sanofi Genzyme to maintain its ownership level of Alnylam common
stock of approximately 12 percent.
- Expanded Alnylam’s Management Team and
Board of Directors.
- Announced new leadership positions with
Alex Leather, M.D., Ph.D., General Manager, EU and Canada; Alfred
Boyle, Ph.D., Senior Vice President, Technical Operations; and Akin
Akinc, Ph.D. as General Manager, Fitusiran.
- Announced changes to our Board of
Directors including the appointment of Michael Bonney as Chairman
and election of David Pyott as a Director.
- Presented corporate updates at our
R&D Day and the J.P. Morgan Annual Healthcare Conference, in
December and January, respectively, and provided guidance on
notable advances we expect to complete over the next two years
including:
- Ten or more major clinical data
readouts in 2016;
- Five or more ongoing Phase 3 trials in
2017; and
- Our first Phase 3 data readout and
NDA/MAA submissions in 2017.
(To view presentations of data described above, please visit
www.alnylam.com/capella)
Upcoming Events in Early and Mid-2016
- Alnylam announced today that it plans
to present the complete 18-month patisiran OLE data in an oral
presentation at the American Academy of Neurology (AAN) annual
meeting on April 20, 2016 in Vancouver, Canada.
- Additional upcoming milestones for
Alnylam pipeline programs include:
- In early 2016, Alnylam plans to:
- File a CTA for ALN-TTRsc02;
- Initiate a Phase 1 study for ALN-GO1;
and
- File a CTA for ALN-HBV.
- In mid-2016, Alnylam plans to:
- Present 24-month patisiran Phase 2 OLE
data;
- Present 12-month revusiran Phase 2 OLE
data;
- Start ALN-TTRsc02 Phase 1 study;
- Present additional fitusiran Phase 1
data;
- Start first fitusiran Phase 3
study;
- Present ALN-CC5 Phase 1/2 data in PNH
patients;
- Present initial Phase 1 data with
ALN-AAT; and
- Start ALN-HBV Phase 1 study.
Financials
“Alnylam continues to maintain a strong balance sheet, ending
2015 with approximately $1.28 billion in cash,” said Michael Mason,
Vice President, Finance and Treasurer. “Our financial strength
allows us to continue to invest in a broad pipeline of
investigational RNAi therapeutics across our three STArs, aligned
with achieving our ‘Alnylam 2020’ goals. As for 2016 financial
guidance, we expect to end 2016 with greater than $850 million in
cash.”
Cash, Cash Equivalents and Total Marketable Securities
At December 31, 2015, Alnylam had cash, cash equivalents and
total marketable securities of $1.28 billion, as compared to $881.9
million at December 31, 2014.
Non-GAAP Net Loss
The non-GAAP net loss for the year ended December 31, 2015 was
$290.1 million, or $3.45 per share on both a basic and diluted
basis as compared to a non-GAAP net loss of $139.6 million, or
$1.88 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 for which there is no corresponding expense
for the year ended December 31, 2015.
GAAP Net Loss
The net loss according to accounting principles generally
accepted in the U.S. (GAAP) for the fourth quarter of 2015 was
$90.7 million, or $1.07 per share on both a basic and diluted basis
(including $15.5 million, or $0.18 per share of non-cash
stock-based compensation expense), as compared to a net loss of
$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), for the same period in the
previous year. For the year ended December 31, 2015, the net loss
was $290.1 million, or $3.45 per share (including $45.8 million, or
$0.55 per share of non-cash stock-based compensation expense), as
compared to a net loss of $360.4 million, or $4.85 per share
(including $33.1 million, or $0.45 per share of non-cash
stock-based compensation expense), for the prior year. The decrease
in net loss for the year ended December 31, 2015 compared to the
prior year resulted primarily from a $220.8 million charge in 2014
to in-process research and development expense in connection with
the purchase of the Sirna RNAi assets from Merck.
Revenues
Revenues were $7.6 million for the fourth quarter of 2015, as
compared to $24.0 million for the same period last year. Revenues
for the fourth quarter of 2015 included $3.6 million from the
company’s alliance with Sanofi Genzyme, $2.9 million from the
Company’s alliance with The Medicines Company and $1.1 million from
other sources. Revenues were $41.1 million for the year ended
December 31, 2015, as compared to $50.6 million for the prior year.
Revenues for the year ended December 31, 2015 included $11.0
million from the company’s alliance with Sanofi Genzyme, $10.3
million from the company’s alliance with The Medicines Company,
$8.9 million of revenues related to the company’s collaboration
with Takeda, $5.6 million of revenues related to the company’s
collaboration with Monsanto, and $5.3 million from other sources.
The decrease in revenues in the quarter and year ended December 31,
2015 compared to the prior year periods was due primarily to the
completion of the Company’s performance obligations under the
Monsanto agreement in February 2015 and the completion of its
revenue amortization under the Takeda agreement in May 2015,
partially offset by higher revenue from its agreement with Sanofi
Genzyme. The company expects net revenues from collaborators to
remain consistent for 2016 as compared to 2015.
Research and Development Expenses
Research and development (R&D) expenses were $82.8 million
in the fourth quarter of 2015 which included $9.3 million of
non-cash stock-based compensation, as compared to $55.5 million in
the fourth quarter of 2014, which included $8.2 million of non-cash
stock-based compensation. R&D expenses were $276.5 million for
the year ended December 31, 2015, which included $27.1 million of
non-cash stock-based compensation, as compared to $190.2 million
for the prior year, which included $18.2 million of non-cash
stock-based compensation. The increase in R&D expenses for the
quarter and year ended December 31, 2015 as compared to the prior
year periods was due primarily to higher clinical trial and
manufacturing and external services expenses resulting primarily
from the significant advancement of the company’s Genetic Medicine
pipeline. In addition, compensation and related expenses increased
for the quarter and year ended December 31, 2015 as compared to the
prior year periods due primarily to a significant increase in
headcount during the period as the company continues to expand and
advance its development pipeline. The Company expects that R&D
expenses will increase in 2016 as it continues to develop its
pipeline and advance its product candidates into clinical
trials.
General and Administrative Expenses
General and administrative (G&A) expenses were $17.2 million
in the fourth quarter of 2015, which included $6.3 million of
non-cash stock-based compensation, as compared to $14.2 million in
the fourth quarter of 2014, which included $5.2 million of non-cash
stock-based compensation. G&A expenses were $60.6 million for
the year ended December 31, 2015, which included $18.7 million of
non-cash stock-based compensation, as compared to $44.5 million in
2014, which included $14.8 million of non-cash stock-based
compensation. G&A expenses for the quarter and year ended
December 31, 2015 as compared to the prior year periods increased
due primarily to increased non-cash stock-based compensation and an
increase in consulting and professional services expenses related
to an increase in general business activities. The Company expects
that G&A expenses will increase in 2016 as it continues to grow
its operations.
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, 2015, the fair market
value of the company’s investment in Regulus was $51.4 million as
compared to $94.6 million at December 31, 2014.
2016 Financial Guidance
Alnylam expects that its cash, cash equivalents, and total
marketable securities balance will be greater than $850 million at
December 31, 2016. This includes approximately $100 million in
expenditures related to Alnylam’s planned capital investment in a
drug substance manufacturing facility.
Conference Call Information
Management will provide an update on the company, discuss fourth
quarter and 2015 results, and discuss expectations for the future
via conference call on Thursday, February 11,
2016 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
45176516. A replay of the call will be available beginning
at 7:30 p.m. ET on February 11, 2016. To access the
replay, please dial 855-859-2056 (domestic) or
404-537-3406 (international), and refer to conference ID
45176516.
Sanofi Genzyme Alliance
In January 2014, Alnylam and Sanofi Genzyme, the specialty
care global business unit of Sanofi, formed an alliance to
accelerate and expand the development and commercialization of RNAi
therapeutics across the world. The alliance is structured as a
multi-product geographic alliance in the field of rare diseases.
Alnylam retains product rights in North
America and Western Europe, while Sanofi Genzyme obtained
the right to access certain programs in Alnylam's current and
future Genetic Medicines pipeline in the rest of the world (ROW)
through the end of 2019, together with certain broader
co-development/co-commercialization rights and global rights for
certain products. In the case of patisiran, Alnylam will advance
the product in North America and Western Europe,
while Sanofi Genzyme will advance the product in the ROW. In the
case of revusiran, Alnylam and Sanofi Genzyme will
co-develop/co-commercialize the product in North America and
Western Europe, while Sanofi Genzyme will advance the product in
the ROW. In the case of fitusiran, Sanofi Genzyme has elected to
opt into the program for its ROW rights, while retaining its
further opt-in right to co-develop and co-promote fitusiran with
Alnylam in North America and Western Europe, subject to certain
restrictions.
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 LNP Technology
Alnylam has licenses to Arbutus 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
Sanofi Genzyme. 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 and offices in the United
Kingdom and Switzerland. 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 views with respect to the potential for RNAi
therapeutics, including patisiran, revusiran, fitusiran, ALN-CC5,
ALN-AS1, ALN-AAT, ALN-GO1, ALN-PCSsc and ALN-HBV, its expectations
regarding its STAr pipeline growth strategy, its “Alnylam 2020”
guidance for the advancement and commercialization of RNAi
therapeutics, its expectations for the timing of filing of
regulatory documents, including but not limited to IND or CTA
submissions for ALN-TTRsc02 and ALN-HBV, and submission of an MAA
and NDA for patisiran, its expectations regarding the timing of the
start of clinical studies and presentation of clinical data,
including its studies for patisiran, revusiran, fitusiran, ALN-CC5,
ALN-AS1, and ALN-AAT, its expected cash position as of December 31,
2016, its expected expenditures related to capital investment in a
drug substance manufacturing facility, and its plans regarding the
pursuit of pre-clinical programs and commercialization of RNAi
therapeutics, 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 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 manage operating expenses, 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 LOSS
(In thousands, except per share
amounts)
Three Months EndedDecember
31,
Year EndedDecember 31,
2015 2014 2015
2014 Net revenues from
collaborators $ 7,551 $ 24,019 $ 41,097 $ 50,561
Operating expenses:
Research and development (1)
82,835 55,546 276,495 190,249 In-process research and development —
— — 220,766 General and administrative (1) 17,228
14,185 60,610 44,526 Total operating expenses
100,063 69,731 337,105 455,541 Loss from
operations (92,512) (45,712) (296,008)
(404,980)
Other income (expense): Interest income 1,616 780
5,859 2,559 Other income 175 1,452 76
1,817 Total other income 1,791 2,232 5,935
4,376 Loss before income taxes (90,721) (43,480) (290,073)
(400,604) Benefit from income taxes — 22,091 —
40,209 Net loss $ (90,721) $ (21,389) $ (290,073) $
(360,395) Net loss per common share - basic and diluted $ (1.07) $
(0.28) $ (3.45) $ (4.85) Weighted-average common shares used to
compute basic and diluted net loss per common share 84,871
76,957 83,992 74,278
Comprehensive
income (loss): Net loss $ (90,721) $ (21,389) $ (290,073) $
(360,395) Unrealized gain (loss) on marketable securities, net of
tax 11,588 35,091 (44,394) 31,127
Reclassification adjustment for realized
gain on marketable securities included in net loss
— (1,514) — (2,081) Comprehensive
(loss) income $ (79,133) $ 12,188 $ (334,467) $ (331,349)
(1) Non-cash stock-based compensation expenses included in
operating expenses are as follows: Research and development $ 9,257
$ 8,214 $ 27,086 $ 18,233 General and administrative 6,263 5,224
18,697 14,828
ALNYLAM PHARMACEUTICALS, INC.
UNAUDITED GAAP TO NON-GAAP
RECONCILIATION: NET LOSS AND NET LOSS PER SHARE
(In thousands, except per share
amounts)
Three Months EndedDecember
31,
Year EndedDecember 31,
2015 2014 2015
2014 GAAP net loss $ (90,721) $ (21,389) $
(290,073) $ (360,395) Adjustment: In-process research and
development — — — 220,766 Non-GAAP net
loss $ (90,721 ) $ (21,389) $ (290,073) $ (139,629)
GAAP net loss per common share - basic and diluted $ (1.07) $
(0.28) $ (3.45) $ (4.85) Adjustment (as detailed above) —
— — 2.97 Non-GAAP net loss per common share -
basic and diluted $ (1.07) $ (0.28) $ (3.45) $ (1.88)
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 exclude the
in-process research and development expense of $220.8 million
related to the purchase of the Sirna RNAi assets from Merck. There
will be no additional charges recorded to in-process research and
development related to this 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,
2015 2014 Cash, cash equivalents
and total marketable securities $ 1,280,951 $ 881,929 Billed and
unbilled collaboration receivables 8,298 39,937 Prepaid expenses
and other assets 18,030 9,739 Deferred tax assets — 31,667 Property
and equipment, net 27,812 21,740 Investment in equity securities of
Regulus Therapeutics Inc. 51,419
94,583
Total assets $ 1,386,510 $
1,079,595 Accounts payable, accrued expenses and other liabilities
$ 46,886 $ 38,791 Deferred tax liabilities — 31,667 Total deferred
revenue 68,317 66,854 Total deferred rent 6,593 6,016 Total
stockholders’ equity (85.1 million and 77.2 million common shares
issued and outstanding and at December 31, 2015 and December 31,
2014, respectively) 1,264,714
936,267
Total liabilities and stockholders' equity $
1,386,510 $ 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.
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Alnylam Pharmaceuticals, Inc.Investors and MediaChristine
Regan Lindenboom, 617-682-4340orInvestorsJosh Brodsky,
617-551-8276
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