[November 07, 2017] |
|
Alnylam Pharmaceuticals Reports Third Quarter 2017 Financial Results and Highlights Recent Period Activity
Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics
company, today reported its consolidated financial results for the third
quarter 2017, and highlighted recent progress in advancing its pipeline.
"In our view, 2017 has proven to be a remarkable year for RNAi
therapeutics, for Alnylam, and, most importantly, for the patients that
we serve. With patisiran, our recent APOLLO Phase 3 study results
demonstrate what we believe to be the transformative potential for RNAi
therapeutics as a new class of innovative medicines. With these data, we
expect to submit our first regulatory filings in the coming months, and
are planning for the possibility of having regulatory approval for
patisiran in mid-2018," said John Maraganore, Ph.D., Chief Executive
Officer of Alnylam. "We have also made significant progress across our
other programs, including the initiation of our ENVISION Phase 3 program
for givosiran in acute hepatic porphyrias and, with our partners at The
Medicines Company, the ORION Phase 3 program in hypercholesterolemia.
Additionally, we aim to resume dosing in all fitusiran studies,
including the ATLAS Phase 3 program, as soon as possible. These
milestones position Alnylam with multiple late-stage clinical assets,
while we concurrently transition into a fully integrated commercial
company with the goal of delivering innovative medicines to patients
around the world."
Third Quarter 2017 and Recent Significant Corporate Highlights
-
Advanced patisiran, an investigational RNAi therapeutic in development
for the treatment of patients with hereditary ATTR (hATTR)
amyloidosis, with positive
results from the APOLLO Phase 3 study (N=225).
-
Patisiran met its primary endpoint (p = 9.26 x 10-24)
with a 34.0 point mean difference relative to placebo and a
negative 6.0 point mean change (improvement) relative to baseline
in the modified neuropathy impairment score (mNIS+7) at 18 months,
as well as all secondary endpoints (p less than 0.001), including
a 21.1 point mean difference relative to placebo and a negative
6.7 point mean change (improvement) relative to baseline in the
NORFOLK Quality of Life-Diabetic Neuropathy score (NORFOLK QOL-DN)
(p = 1.10 x 10-10), at 18 months.
-
Patisiran also demonstrated a favorable safety and tolerability
profile relative to placebo. The most commonly reported adverse
events (AEs) for patisiran were generally mild to moderate and
included peripheral edema (29.7 percent) and infusion-related
reactions (IRRs) (18.9 percent), and the frequency of deaths and
serious adverse events (SAEs) was similar in the patisiran and
placebo groups. No deaths were considered drug-related.
-
Specifically, the Company believes that these data support a
potentially "best-in-class" product profile, with significant
benefit relative to placebo, negative mean and median values
(improvement) for mNIS+7 and QOL measures relative to baseline,
and encouraging safety and tolerability.
-
In addition, patisiran achieved significant effects in the study's
cardiac subpopulation, including on disease biomarker,
echocardiographic, and functional parameters.
-
The Company believes the totality of the APOLLO data are
consistent with a clinically meaningful impact for patisiran on
hATTR amyloidosis, and plans to submit an NDA for patisiran by the
end of 2017 and a Marketing Authorisation Application (MAA)
shortly thereafter.
-
Advanced ALN-TTRsc02, a subcutaneously administered investigational
RNAi therapeutic in development for the treatment of ATTR amyloidosis.
-
Presented updated
Phase 1 data showing up to 95% transthyretin (TTR) knockdown
with a single 50 mg dose, with durability supportive of a once
quarterly and, possibly, bi-annual subcutaneous dose regimen.
-
Reaffirmed guidance to initiate a Phase 3 program for ALN-TTRsc02
in 2018.
-
Advanced givosiran, an investigational RNAi therapeutic in development
for the treatment of acute hepatic porphyrias (AHPs), with initiation
of the ENVISION Phase 3 study.
-
The Company reached alignment with the U.S. Food and Drug
Administration (FDA) on the design of ENVISION, including an
interim analysis based on reduction of urinary aminolevulinic acid
(ALA), a biomarker that the FDA considers to be reasonably likely
to predict clinical benefit.
-
The Company has also reached alignment on the ENVISION Phase 3
study design with the European Medicines Agency (EMA).
-
The Company is guiding that it expects interim analysis results in
mid-2018 and, pending FDA review of the program at the time of
interim analysis and assuming positive results, it expects to
submit an NDA at or around year-end 2018.
-
Advanced fitusiran, an investigational RNAi therapeutic in development
for the treatment of hemophilia A and B with or without inhibitors,
with new
positive data from the Phase 2 open-label extension (OLE)
study presented at the International Society on Thrombosis and
Haemostasis 2017 Congress.
-
Results from the Phase 1 study were published in The
New England Journal of Medicine in a paper titled,
"Targeting of Antithrombin in Hemophilia A or B with RNAi Therapy."
-
Announced the initiation of the ATLAS Phase 3 program, a global,
multicenter clinical program designed to evaluate the safety and
efficacy of fitusiran in patients with hemophilia A and B with or
without inhibitors.
-
The Company temporarily suspended dosing in all ongoing studies of
fitusiran following the observation of a fatal thrombotic SAE that
occurred in a patient with hemophilia A without inhibitors who was
receiving fitusiran in the Phase 2 OLE study. Alnylam and
fitusiran study investigators have aligned on a risk management
plan for further advancement of fitusiran and are now conferring
with global regulators with the goal of resuming dosing as soon as
possible, potentially by the end of 2017.
-
Alnylam and The Medicines Company announced initiation of the ORION-11
Phase 3 study of inclisiran, an investigational RNAi therapeutic
targeting PCSK9 in development for the treatment of
hypercholesterolemia, in patients with atherosclerotic cardiovascular
disease (ASCVD).
-
The companies announced new
positive data from the ORION-1 Phase 2 study of
inclisiran at the European Society of Cardiology Congress 2017.
-
Advanced cemdisiran (formerly known as ALN-CC5), a subcutaneously
administered investigational RNAi therapeutic targeting complement
component C5 for the treatment of complement-mediated diseases, with
the initiation of a Phase 2 clinical study in patients with atypical
hemolytic-uremic syndrome (aHUS).
-
Advanced lumasiran (formerly known as ALN-GO1), an investigational
RNAi therapeutic in development for the treatment of primary
hyperoxaluria type 1 (PH1), with new
positive data from the Phase 1/2 study presented at the
American Society of Nephrology Kidney Week 2017 Annual Meeting.
-
Alnylam announced a licensing agreement with Vir Biotechnology for the
development and commercialization of RNAi therapeutics for infectious
diseases, including hepatitis B.
-
Advanced RNAi platform technology with new
pre-clinical data on Alnylam's next generation "Enhanced
Stabilization Chemistry Plus" (ESC+) GalNAc-siRNA conjugate platform
presented at the 13th Annual Meeting of the Oligonucleotide
Therapeutics Society.
Upcoming Events
-
Alnylam announces today that Alnylam scientists and collaborators will
present new results from multiple pipeline programs at the 59th
American Society of Hematology (ASH) Annual Meeting, being held
December 9 - 12, 2017 in Atlanta, Georgia. Presentations include:
-
Explore: A Prospective, Multinational History Study of Patients
with Acute Hepatic Porphyrias (AHP) with Recurrent Attacks
Session:
102. Regulation of Iron Metabolism: Poster II Date/Time:
Sunday, December 10, 6:00 - 8:00 p.m. ET
-
Perioperative Management in Patients with Hemophilia Receiving
Fitusiran, an Investigational RNAi Therapeutic Targeting
Antithrombin for the Treatment of Hemophilia
Session: 322.
Disorders of Coagulation or Fibrinolysis: Poster II Date/Time:
Sunday, December 10, 6:00 - 8:00 p.m. ET
-
In Silico Modeling of the Impact of Antithrombin Lowering on
Thrombin Generation in Rare Bleeding Disorders
Session: 321.
Blood Coagulation and Fibrinolytic Factors: Poster III Date/Time:
Monday, December 11, 6:00 - 8:00 p.m. ET
-
Alnylam plans to file its first NDA for patisiran with the FDA by the
end of 2017, followed by an MAA in the EU in early 2018.
-
Alnylam plans to meet with global regulatory authorities with the goal
of reaching agreement on a risk mitigation plan and resumption of
dosing in fitusiran clinical studies.
Financial results for the quarter ended September 30, 2017
"Alnylam's strong balance sheet and overall financial position allow us
to build our commercial capabilities in preparation for anticipated
product launches in the U.S. and Western Europe during 2018, assuming
regulatory approvals in the U.S. and EU," said Manmeet Soni, Chief
Financial Officer of Alnylam. "Additionally, we continue to invest in
our broad pipeline of investigational RNAi therapeutics, advancing our
four late-stage programs as well as the early-stage pipeline programs."
Cash and Investments At September 30, 2017, Alnylam had
cash, cash equivalents and fixed income marketable securities, and
restricted investments of $1.15 billion, as compared to $1.09 billion at
December 31, 2016.
GAAP and Non-GAAP Net Loss The net loss according to
accounting principles generally accepted in the U.S. (GAAP) for the
third quarter of 2017 was $122.9 million, or $1.34 per share on both a
basic and diluted basis, as compared to a net loss of $104.1 million, or
$1.21 per share on both a basic and diluted basis, for the same period
in the previous year.
The non-GAAP net loss for the third quarter of 2017 was $97.0 million,
or $1.06 per share on both a basic and diluted basis, as compared to a
non-GAAP net loss of $88.5 million, or $1.03 per share on both a basic
and diluted basis for the same period in the previous year.
The non-GAAP net loss excludes stock-based compensation expense. See
"Use of Non-GAAP Financial Measures" below for a description of non-GAAP
financial measures and a reconciliation between GAAP and non-GAAP net
loss appearing later in this press release.
Revenues Revenues were $17.1 million in the third quarter of
2017, as compared to $13.7 million in the third quarter of 2016.
Revenues for the third quarter of 2017 included $14.6 million from the
Company's alliance with Sanofi Genzyme, $2.3 million from the Company's
alliance with The Medicines Company and $0.2 million from other sources.
GAAP and Non-GAAP Research and Development Expenses GAAP
research and development (R&D) expenses were $95.3 million in the third
quarter of 2017 as compared to $97.9 million in the third quarter of
2016.
Non-GAAP R&D expenses were $80.2 million in the third quarter of 2017 as
compared to $88.6 million in the third quarter of 2016. Non-GAAP R&D
expenses exclude stock-based compensation expense. A reconciliation
between GAAP and non-GAAP R&D expenses appears later in this press
release.
GAAP and Non-GAAP General and Administrative Expenses GAAP
general and administrative (G&A) expenses were $47.6 million in the
third quarter of 2017 as compared to $22.4 million in the third quarter
of 2016.
Non-GAAP G&A expenses were $36.8 million in the third quarter of 2017 as
compared to $16.2 million in the third quarter of 2016. Non-GAAP G&A
expenses exclude stock-based compensation expense. A reconciliation
between GAAP and non-GAAP G&A expenses appears later in this press
release.
Financial Guidance Alnylam remains on track to end 2017 with
greater than $1.0 billion in cash, cash equivalents and fixed income
marketable securities including $150.0 million in restricted investments.
Conference Call Information Management will provide an
update on the Company and discuss third quarter 2017 results as well as
expectations for the future via conference call on Tuesday, November 7,
2017 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 2432127. A replay of the call will
be available beginning at 7:30 p.m. ET on the day of the call. To access
the replay, please dial 855-859-2056 (domestic) or 404-537-3406
(international), and refer to conference ID 2432127.
Alnylam - Sanofi Genzyme Alliance In January 2014, Alnylam
and Sanofi Genzyme, the specialty care global business unit of Sanofi,
formed an alliance to accelerate the advancement of RNAi therapeutics as
a potential new class of innovative medicines for patients around the
world with rare genetic diseases. The alliance enables Sanofi Genzyme to
expand its rare disease pipeline with Alnylam's novel RNAi technology
and provides access to Alnylam's R&D engine, while Alnylam benefits from
Sanofi Genzyme's proven global capabilities to advance late-stage
development and, upon commercialization, accelerate market access for
these promising genetic medicine products.
In the case of patisiran, Alnylam will advance the product in the United
States, Canada and Western Europe, while Sanofi Genzyme will advance the
product in the rest of the world. In November 2016, Sanofi Genzyme
elected to co-develop (through Sanofi R&D) and co-commercialize
fitusiran in the United States, Canada and Western Europe, in addition
to commercializing fitusiran in its rest of world territories. Sanofi
Genzyme has the right to opt in to develop and commercialize lumasiran
in territories outside of the United States, Canada and Western Europe
and could elect to exercise its one right to a global license for
lumasiran. In the case of ALN-TTRsc02, Sanofi Genzyme has the right to
opt into the program with co-development/co-commercialization rights.
About RNAi RNAi (RNA interference) is a natural cellular
process of gene silencing that represents one of the most promising and
rapidly advancing frontiers in biology and drug development today. Its
discovery has been heralded as "a major scientific breakthrough that
happens once every decade or so," and was recognized with the award of
the 2006 Nobel Prize for Physiology or Medicine. By harnessing the
natural biological process of RNAi occurring in our cells, 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, function upstream of today's
medicines by potently silencing messenger RNA (mRNA) - the genetic
precursors - that encode for disease-causing proteins, thus preventing
them from being made. This is a revolutionary approach with the
potential to transform the care of patients with genetic and other
diseases.
About LNP Technology Alnylam has licenses to Arbutus LNP
intellectual property for use in RNAi therapeutic products using LNP
technology.
About Alnylam Pharmaceuticals Alnylam (Nasdaq: ALNY) is
leading the translation of RNA interference (RNAi) into a whole new
class of innovative medicines with the potential to transform the lives
of people afflicted with rare genetic, cardio-metabolic, and hepatic
infectious diseases. Based on Nobel Prize-winning science, RNAi
therapeutics represent a powerful, clinically validated approach for the
treatment of a wide range of severe and debilitating diseases. Founded
in 2002, Alnylam is delivering on a bold vision to turn scientific
possibility into reality, with a robust discovery platform and deep
pipeline of investigational medicines, including four product candidates
that are in late-stage development. Looking forward, Alnylam will
continue to execute on its "Alnylam 2020" strategy of building a
multi-product, commercial-stage biopharmaceutical company with a
sustainable pipeline of RNAi-based medicines to address the needs of
patients who have limited or inadequate treatment options. Alnylam
employs over 600 people in the U.S. and Europe and is headquartered in
Cambridge, MA. For more information about our people, science and
pipeline, please visit www.alnylam.com
and engage with us on Twitter at @Alnylam
or on LinkedIn.
Use of Non-GAAP Financial Measures This press release
contains non-GAAP financial measures, including expenses adjusted to
exclude certain non-cash expenses. These measures are not in accordance
with, or an alternative to, GAAP, and may be different from non-GAAP
financial measures used by other companies.
The item included in GAAP presentations but excluded for purposes of
determining non-GAAP financial measures for the periods presented in the
press release is stock-based compensation expense. The Company has
excluded the impact of stock-based compensation expense, which may
fluctuate from period to period based on factors including the
variability associated with performance-based grants for stock options
and restricted stock units and changes in the Company's stock price,
which impacts the fair value of these awards.
The Company believes the presentation of non-GAAP financial measures
provides useful information to management and investors regarding the
Company's financial condition and results of operations. When GAAP
financial measures are viewed in conjunction with non-GAAP financial
measures, investors are provided with a more meaningful understanding of
the Company's ongoing operating performance. In addition, these non-GAAP
financial measures are among those indicators the Company uses as a
basis for evaluating performance, allocating resources and planning and
forecasting future periods. Non-GAAP financial measures are not intended
to be considered in isolation or as a substitute for GAAP financial
measures. A reconciliation between GAAP and non-GAAP measures is
provided later in this press release.
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, fitusiran,
givosiran, inclisiran, cemdisiran and lumasiran, its expectations
regarding the timing of clinical studies and the presentation of
clinical data, including for studies for fitusiran, givosiran,
inclisiran, cemdisiran and lumasiran, its expectations regarding the
potential of its ESC+ GalNAc-siRNA conjugate platform, its expectations
regarding the potential filing of an NDA for patisiran by the end of
2017 and an MAA shortly thereafter, its expected transition to
commercial operations in mid-2018 if patisiran is approved, its plans
for the development and commercialization of RNAi therapeutics for
infectious diseases with Vir Biotechnology, its expected cash, cash
equivalents, fixed income marketable securities and restricted
investments position as of December 31, 2017, and its "Alnylam 2020"
guidance for the advancement 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 and future plans may differ materially from those
indicated by these forward-looking statements as a result of various
important risks, uncertainties and other 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 product 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 for a
specified indication or at all, actions or advice of regulatory
agencies, which may affect the design, initiation, timing, continuation
and/or progress of clinical trials or result in the need for additional
pre-clinical and/or clinical testing, delays, interruptions or failures
in the manufacture and supply of our product candidates, obtaining,
maintaining and protecting intellectual property, Alnylam's ability to
enforce its intellectual property rights against third parties and
defend its patent portfolio against challenges from third parties,
obtaining and maintaining regulatory approval, pricing and reimbursement
for products, progress in establishing a commercial and ex-United States
infrastructure, competition from others using technology similar to
Alnylam's and others developing products for similar uses, Alnylam's
ability to manage its growth and operating expenses, 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 and
distribution of products, the outcome of litigation, the risk of
government investigations, 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, except to the extent required by law, to update any
forward-looking statements.
The scientific information referenced in this news release relating to
Alnylam's investigational therapeutics is preliminary and investigative.
None of Alnylam's investigational therapeutics, including inclisiran,
which is partnered with The Medicines Company, have been approved by the
U.S. Food and Drug Administration, European Medicines Agency, or any
other regulatory authority and no conclusions can or should be drawn
regarding the safety or effectiveness of these therapeutics.
|
ALNYLAM PHARMACEUTICALS, INC. UNAUDITED CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (In
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from collaborators
|
|
|
$
|
17,096
|
|
|
$
|
13,651
|
|
|
$
|
51,988
|
|
|
$
|
29,705
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
95,252
|
|
|
|
97,936
|
|
|
|
272,863
|
|
|
|
277,381
|
|
General and administrative
|
|
|
|
47,644
|
|
|
|
22,391
|
|
|
|
131,910
|
|
|
|
61,478
|
|
Total operating expenses
|
|
|
|
142,896
|
|
|
|
120,327
|
|
|
|
404,773
|
|
|
|
338,859
|
|
Loss from operations
|
|
|
|
(125,800
|
)
|
|
|
(106,676
|
)
|
|
|
(352,785
|
)
|
|
|
(309,154
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
3,296
|
|
|
|
2,204
|
|
|
|
8,001
|
|
|
|
6,109
|
|
Other (expense) income
|
|
|
|
(433
|
)
|
|
|
401
|
|
|
|
(3,863
|
)
|
|
|
5,871
|
|
Total other income
|
|
|
|
2,863
|
|
|
|
2,605
|
|
|
|
4,138
|
|
|
|
11,980
|
|
Net loss
|
|
|
$
|
(122,937
|
)
|
|
$
|
(104,071
|
)
|
|
$
|
(348,647
|
)
|
|
$
|
(297,174
|
)
|
Net loss per common share - basic and diluted
|
|
|
$
|
(1.34
|
)
|
|
$
|
(1.21
|
)
|
|
$
|
(3.93
|
)
|
|
$
|
(3.48
|
)
|
Weighted-average common shares used to compute basic and diluted
net loss per common share
|
|
|
|
91,828
|
|
|
|
85,716
|
|
|
|
88,672
|
|
|
|
85,513
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
$
|
(122,937
|
)
|
|
$
|
(104,071
|
)
|
|
$
|
(348,647
|
)
|
|
$
|
(297,174
|
)
|
Unrealized gain (loss) on marketable securities, net of tax
|
|
|
|
218
|
|
|
|
1,224
|
|
|
|
(2,194
|
)
|
|
|
(25,331
|
)
|
Reclassification adjustment for realized loss (gain) on marketable
securities included in net loss
|
|
|
|
-
|
|
|
|
(706
|
)
|
|
|
1,894
|
|
|
|
(6,816
|
)
|
Comprehensive loss
|
|
|
$
|
(122,719
|
)
|
|
$
|
(103,553
|
)
|
|
$
|
(348,947
|
)
|
|
$
|
(329,321
|
)
|
|
|
|
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC. RECONCILIATION OF
SELECTED GAAP MEASURES TO NON-GAAP MEASURES (In
thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Reconciliation of GAAP to Non-GAAP Research and development:
|
|
|
|
|
|
|
|
|
|
GAAP Research and development
|
|
|
$
|
95,252
|
|
|
$
|
97,936
|
|
|
$
|
272,863
|
|
|
$
|
277,381
|
|
Less: Stock-based compensation expenses
|
|
|
|
(15,090
|
)
|
|
|
(9,341
|
)
|
|
|
(37,035
|
)
|
|
|
(32,974
|
)
|
Non-GAAP Research and development
|
|
|
$
|
80,162
|
|
|
$
|
88,595
|
|
|
$
|
235,828
|
|
|
$
|
244,407
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP General and administrative:
|
|
|
|
|
|
|
|
|
|
GAAP General and administrative
|
|
|
$
|
47,644
|
|
|
$
|
22,391
|
|
|
$
|
131,910
|
|
|
$
|
61,478
|
|
Less: Stock-based compensation expenses
|
|
|
|
(10,865
|
)
|
|
|
(6,240
|
)
|
|
|
(28,667
|
)
|
|
|
(21,903
|
)
|
Non-GAAP General and administrative
|
|
|
$
|
36,779
|
|
|
$
|
16,151
|
|
|
$
|
103,243
|
|
|
$
|
39,575
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP Operating expenses:
|
|
|
|
|
|
|
|
|
|
GAAP Operating expenses
|
|
|
$
|
142,896
|
|
|
$
|
120,327
|
|
|
$
|
404,773
|
|
|
$
|
338,859
|
|
Less: Stock-based compensation expenses
|
|
|
|
(25,955
|
)
|
|
|
(15,581
|
)
|
|
|
(65,702
|
)
|
|
|
(54,877
|
)
|
Non-GAAP Operating expenses
|
|
|
$
|
116,941
|
|
|
$
|
104,746
|
|
|
$
|
339,071
|
|
|
$
|
283,982
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP Net loss:
|
|
|
|
|
|
|
|
|
|
GAAP Net loss
|
|
|
$
|
(122,937
|
)
|
|
$
|
(104,071
|
)
|
|
$
|
(348,647
|
)
|
|
$
|
(297,174
|
)
|
Add: Stock-based compensation expenses
|
|
|
|
25,955
|
|
|
|
15,581
|
|
|
|
65,702
|
|
|
|
54,877
|
|
Non-GAAP Net loss
|
|
|
$
|
(96,982
|
)
|
|
$
|
(88,490
|
)
|
|
$
|
(282,945
|
)
|
|
$
|
(242,297
|
)
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP to Non-GAAP Net loss per common
share-basic and diluted:
|
|
|
|
|
|
|
|
|
|
GAAP Net loss per common share - basic and diluted
|
|
|
$
|
(1.34
|
)
|
|
$
|
(1.21
|
)
|
|
$
|
(3.93
|
)
|
|
$
|
(3.48
|
)
|
Add: Stock-based compensation expenses
|
|
|
|
0.28
|
|
|
|
0.18
|
|
|
|
0.74
|
|
|
|
0.65
|
|
Non-GAAP Net loss per common share - basic and diluted
|
|
|
$
|
(1.06
|
)
|
|
$
|
(1.03
|
)
|
|
$
|
(3.19
|
)
|
|
$
|
(2.83
|
)
|
|
|
|
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC. UNAUDITED CONDENSED
CONSOLIDATED BALANCE SHEETS (In thousands, except
share amounts)
|
|
|
|
|
|
|
|
|
|
September 30, 2017
|
|
December 31, 2016
|
Cash, cash equivalents and fixed income marketable securities
|
|
|
$
|
999,837
|
|
$
|
942,601
|
Restricted investments
|
|
|
|
150,000
|
|
|
150,000
|
Billed and unbilled collaboration receivables
|
|
|
|
14,644
|
|
|
23,334
|
Prepaid expenses and other assets
|
|
|
|
31,901
|
|
|
32,303
|
Property, plant and equipment, net
|
|
|
|
161,899
|
|
|
114,572
|
Total assets
|
|
|
$
|
1,358,281
|
|
$
|
1,262,810
|
Accounts payable, accrued expenses and other liabilities
|
|
|
$
|
63,341
|
|
$
|
99,650
|
Total deferred revenue
|
|
|
|
76,888
|
|
|
82,932
|
Total deferred rent
|
|
|
|
9,217
|
|
|
10,007
|
Long-term debt
|
|
|
|
150,000
|
|
|
150,000
|
Total stockholders' equity (92.4 million and 85.9 million common
shares issued an outstanding at September 30, 2017 and
December 31, 2016, respectively)
|
|
|
|
1,058,835
|
|
|
920,221
|
Total liabilities and stockholders' equity
|
|
|
$
|
1,358,281
|
|
$
|
1,262,810
|
|
|
|
|
|
|
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, 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171107006412/en/
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