− Achieved Third Quarter 2019 ONPATTRO® Global
Net Product Revenues of $46.1 Million, Including Initial Sales in
Japan, with Over 600 Patients on Commercial Product Worldwide –
− Initiated APOLLO-B Phase 3 Study of Patisiran
for the Treatment of Hereditary and Wild-Type ATTR Amyloidosis with
Cardiomyopathy –
– Advanced Additional Late-Stage Clinical
Programs; On Track to Report Topline ILLUMINATE-A Phase 3 Results
with Lumasiran by Year-End –
− Alnylam’s Partner, The Medicines Company,
Announced Positive Phase 3 Results with Inclisiran, in Development
for the Treatment of Hypercholesterolemia –
− Maintained Strong Balance Sheet with $1.74
Billion in Cash and Investments –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today reported its consolidated financial
results for the third quarter 2019 and reviewed recent business
highlights.
“In the third quarter of 2019 and recent period we saw strong
execution on the global commercialization of ONPATTRO. For the rest
of the year and beyond, we expect steady and continued growth in
patients on ONPATTRO therapy through improved disease awareness,
new patient finding, expansion in global markets – such as our
recent launch in Japan and NDA filing in Brazil – and the potential
for future label expansion in hereditary and wild-type ATTR
cardiomyopathy through our recently initiated APOLLO-B Phase 3
study. We’re also pleased to have received a Priority Review and
Accelerated Assessment for givosiran from the FDA and EMA,
respectively, and we are preparing for the potential launch of our
second RNAi therapeutic in the coming months, assuming positive
regulatory reviews,” said John Maraganore, Ph.D., Chief Executive
Officer of Alnylam. “While executing on our commercial objectives,
we also made excellent progress on our late stage pipeline,
including positive Phase 3 results for inclisiran announced by our
partner, The Medicines Company, representing what we believe is a
landmark event for Alnylam and for the entire field of RNAi
therapeutics. In the final months of 2019, we aim to extend this
encouraging track record with pivotal data from our lumasiran
program, continued enrollment in our HELIOS-A Phase 3 trial and
initiation of the HELIOS-B Phase 3 study with vutrisiran. Each of
these anticipated milestones will bring us closer to achieving our
Alnylam 2020 goals of building a multi-product, global biopharma
company with a deep clinical pipeline to fuel future growth and a
robust product engine for sustainable and organic innovation, a
profile rarely achieved in our industry.”
Third Quarter 2019 and Recent Significant Corporate
Highlights
Commercial Performance in Third Quarter 2019
- Achieved global net product revenues for the third quarter of
2019 of $46.1 million for ONPATTRO.
- Attained over 600 patients worldwide on commercial ONPATTRO
treatment since launch.
- Continued global expansion with receipt of regulatory approval
for ONPATTRO in Switzerland, and initiation of commercial launches
in Japan and Canada.
- Continued progress with market access efforts across the CEMEA
region (Canada, Europe, Middle East,
and Africa).
- Following favorable ratings from health technology assessment
agencies, achieved reimbursement approvals in the United Kingdom,
Belgium, and Germany.
- Received recognition for ONPATTRO as an innovative
biotechnology medicine through award of the prestigious Prix Galien
in The Netherlands and Italy and nominations for the Prix Galien in
additional countries, including France, Germany, and the U.S.
Late Stage R&D Highlights
- Advanced patisiran (the non-proprietary name for ONPATTRO), an
intravenously administered investigational RNAi therapeutic in
development for the treatment of ATTR amyloidosis.
- Initiated the APOLLO-B Phase 3 study in ATTR amyloidosis
patients with cardiomyopathy.
- Filed a marketing authorization application with the Brazilian
Health Regulatory Agency (ANVISA) for the treatment of hereditary
ATTR amyloidosis with polyneuropathy.
- Advanced vutrisiran, a subcutaneously administered
investigational RNAi therapeutic in development for the treatment
of ATTR amyloidosis.
- Continued enrollment in the HELIOS-A Phase 3 study in
hereditary ATTR amyloidosis patients with polyneuropathy.
- Aligned with regulatory agencies on the design of the HELIOS-B
Phase 3 study in patients with hereditary or wild-type ATTR
amyloidosis with cardiomyopathy, and are on track to initiate the
study in late 2019.
- Advanced givosiran, an investigational RNAi therapeutic in
development for the treatment of acute hepatic porphyria (AHP).
- Received Priority Review from the U.S. Food and Drug
Administration (FDA) for the givosiran New Drug Application (NDA).
The FDA set an action date of February 4, 2020 under the
Prescription Drug User Fee Act (PDUFA), and the agency has
indicated that it is not currently planning an advisory committee
meeting as part of the NDA review.
- Completed submission of a Marketing Authorization Application
(MAA) under an Accelerated Assessment to the European Medicines
Agency (EMA).
- Presented new clinical results at the 2019 International
Congress on Porphyrins and Porphyrias.
- Advanced lumasiran, an investigational RNAi therapeutic in
development for the treatment of primary hyperoxaluria type 1
(PH1).
- The Company remains on track to report topline results from the
ILLUMINATE-A Phase 3 study in late 2019.
- Continued enrollment in ILLUMINATE-B, a global Phase 3
pediatric study of lumasiran in PH1 patients under six years of
age.
- Presented new clinical results on the pediatric cohort of
patients from the Phase 1/2 study at the International Pediatric
Nephrology Association (IPNA) 2019 Annual Meeting.
- Alnylam’s partner, The Medicines Company, reported positive
results from Phase 3 studies with inclisiran, an investigational
RNAi therapeutic in development for the treatment of
hypercholesterolemia, including:
- Positive complete results from the ORION-11 Phase 3 study in
patients with atherosclerotic cardiovascular disease (ASCVD)
(ex-U.S.), presented at the European Society of Cardiology’s ESC
Congress 2019.
- Positive topline results from the ORION-9 Phase 3 study in
patients with heterozygous familial hypercholesterolemia
(HeFH).
- Positive topline results from the ORION-10 Phase 3 study in
patients with ASCVD (U.S.-based).
Additional Business Updates
- Received recognition as the world’s #1 biopharma employer from
Science magazine based on more than 7,500 responses to its annual
survey of the biotech and pharmaceutical industry.
- Entered into a U.S. gastroenterologist disease education and
post-approval promotional agreement with Ironwood Pharmaceuticals
for the investigational RNAi therapeutic givosiran, to augment
Alnylam’s broader education and commercial activities.
- Announced the +myFamily program as part of the existing
collaboration with 23andMe to offer free 23andMe Health + Ancestry
kits to first-degree family members of 23andMe customers with a
detected TTR variant.
- Announced the appointment of Jeff Poulton as Executive Vice
President, Chief Financial Officer.
Upcoming Events
In late 2019, Alnylam intends to:
- Continue global expansion of ONPATTRO.
- Prepare for the potential launch of givosiran in the U.S. and
Europe, assuming regulatory approvals.
- Initiate the HELIOS-B Phase 3 study of vutrisiran in hereditary
and wild-type ATTR amyloidosis patients with cardiomyopathy.
- Report topline results from the ILLUMINATE-A Phase 3 study of
lumasiran.
- Initiate the ILLUMINATE-C Phase 3 study of lumasiran in PH1
patients with severe renal impairment.
- Present a review of its R&D and commercial activities at
the Company’s R&D Day on November 22 in New York City.
In addition, The Medicines Company plans to report complete
results from the ORION-9 and 10 Phase 3 studies of inclisiran at
the American Heart Association Scientific Sessions 2019, taking
place November 16 – 18 in Philadelphia. The Medicines Company also
plans to file an NDA for inclisiran by year-end 2019.
Financial Results for the Quarter Ended September 30,
2019
“Having recently joined Alnylam as CFO, I have been very
impressed by the strong commercial execution of the organization,
building on the Company’s heritage of scientific excellence and
R&D success. Notably, we finished the third quarter with over
600 patients on commercial ONPATTRO and generated $46.1 million in
global net product revenues with strong growth contributions from
both our U.S. and international markets,” said Jeff Poulton, Chief
Financial Officer of Alnylam. “As we look towards 2020 and beyond,
our balance sheet remains strong, supporting further investment in
both commercial and R&D programs to drive near- and long-term
growth, which we believe will bring us closer to achieving a
self-sustainable financial profile for the future.”
Cash and Investments At September 30, 2019, Alnylam had cash,
cash equivalents and marketable debt securities, and restricted
investments, excluding equity securities, of $1.74 billion, as
compared to $1.13 billion at December 31, 2018.
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 2019 was $208.5 million, or $1.92 per share on both a
basic and diluted basis, as compared to a net loss of $245.3
million, or $2.43 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 2019 was $162.5
million, or $1.50 per share on both a basic and diluted basis, as
compared to a non-GAAP net loss of $157.3 million, or $1.56 per
share on both a basic and diluted basis, for the same period in the
previous year.
Reconciling items between GAAP and non-GAAP net loss for the
third quarter of 2019 and 2018 include 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.
ONPATTRO Revenues, Net Net product revenues from sales of
ONPATTRO were $46.1 million in the third quarter of 2019, as
compared to net product revenues of $0.5 million for the same
period in the previous year.
Net Revenues from Collaborators Net revenues from collaborators
were $24.0 million in the third quarter of 2019, primarily related
to $15.3 million in revenue from the Regeneron collaboration, as
compared to $1.6 million in the third quarter of 2018.
GAAP and Non-GAAP Research and Development Expenses GAAP
research and development (R&D) expenses were $160.8 million in
the third quarter of 2019, as compared to $139.9 million in the
third quarter of 2018.
Non-GAAP R&D expenses were $138.1 million in the third
quarter of 2019, as compared to $94.2 million in the third quarter
of 2018. 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 Selling, General and Administrative Expenses
GAAP selling, general and administrative (SG&A) expenses were
$120.4 million in the third quarter of 2019, as compared to $116.5
million in the third quarter of 2018.
Non-GAAP SG&A expenses were $97.1 million in the third
quarter of 2019, as compared to $74.4 million in the third quarter
of 2018. Non-GAAP SG&A expenses exclude stock-based
compensation expense. A reconciliation between GAAP and non-GAAP
SG&A expenses appears later in this press release.
2019 Financial Guidance Alnylam reiterates its
expectations for 2019 non-GAAP R&D expenses to be in the range
of $550 to $575 million and non-GAAP SG&A expenses to be in the
range of $390 to $400 million. Both non-GAAP R&D and non-GAAP
SG&A expenses exclude stock-based compensation expenses.
The Company expects its current cash, cash equivalents, and
marketable debt securities will support company operations for
multiple years based upon its current operating plan.
Use of Non-GAAP Financial Measures This press release
contains non-GAAP financial measures, including expenses adjusted
to exclude certain non-cash expenses and non-recurring gains
outside the ordinary course of the Company’s business. 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 items included in GAAP presentations but excluded for
purposes of determining non-GAAP financial measures for the periods
presented in the press release are stock-based compensation
expense, a gain on the change in fair value of a liability
obligation, and a gain on litigation settlement. 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 has excluded the impact of a gain on the change in fair
value of a liability obligation and the gain on litigation
settlement because the Company believes these items are one-time
events occurring outside the ordinary course of the Company’s
business.
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 and are better able to compare the Company’s
performance between periods. 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.
The Company does not provide in this press release a
reconciliation of its estimated 2019 non-GAAP R&D and non-GAAP
SG&A expense guidance to the comparable GAAP measures because
it is not able to estimate 2019 stock-based compensation expense
without unreasonable efforts. The Company’s stock-based
compensation expense is subject to significant fluctuations from
period to period due to variability in the probability of
performance-based vesting events for stock options and restricted
stock units and changes in the Company’s stock price which
materially impact the recognition, timing of expense and fair value
of these awards. In addition, the Company believes such
reconciliations for its 2019 financial guidance would imply a
degree of precision that would be confusing or misleading to
investors.
Conference Call Information Management will provide an
update on the Company and discuss third quarter 2019 results as
well as expectations for the future via conference call on
Thursday, October 31, 2019 at 8:30 am ET. To access the call,
please dial 866-548-4713 (domestic) or +1-323-794-2093
(international) five minutes prior to the start time and refer to
conference ID 2198008. A replay of the call will be available
beginning at 11:30 am ET on the day of the call. To access the
replay, please dial 888-203-1112 (domestic) or +1-719-457-0820
(international) and refer to conference ID 2198008.
About ONPATTRO® (patisiran) ONPATTRO is an RNAi
therapeutic that is approved in the United States and Canada for
the treatment of the polyneuropathy of hATTR amyloidosis in adults.
ONPATTRO is also approved in the European Union and Switzerland for
the treatment of hATTR amyloidosis in adults with Stage 1 or Stage
2 polyneuropathy, and in Japan for the treatment of hATTR
amyloidosis with polyneuropathy. Based on Nobel Prize-winning
science, ONPATTRO is an intravenously administered RNAi therapeutic
targeting transthyretin (TTR) for the treatment of hereditary ATTR
amyloidosis. It is designed to target and silence TTR messenger
RNA, thereby blocking the production of TTR protein before it is
made. ONPATTRO blocks the production of TTR in the liver, reducing
its accumulation in the body’s tissues in order to halt or slow
down the progression of the disease.
ONPATTRO Important Safety Information
Infusion-Related Reactions Infusion-related reactions (IRRs)
have been observed in patients treated with ONPATTRO. In a
controlled clinical study, 19 percent of ONPATTRO-treated patients
experienced IRRs, compared to 9 percent of placebo-treated
patients. The most common symptoms of IRRs with ONPATTRO were
flushing, back pain, nausea, abdominal pain, dyspnea, and
headache.
To reduce the risk of IRRs, patients should receive
premedication with a corticosteroid, acetaminophen, and
antihistamines (H1 and H2 blockers) at least 60 minutes prior to
ONPATTRO infusion. Monitor patients during the infusion for signs
and symptoms of IRRs. If an IRR occurs, consider slowing or
interrupting the infusion and instituting medical management as
clinically indicated. If the infusion is interrupted, consider
resuming at a slower infusion rate only if symptoms have resolved.
In the case of a serious or life-threatening IRR, the infusion
should be discontinued and not resumed.
Reduced Serum Vitamin A Levels and Recommended Supplementation
ONPATTRO treatment leads to a decrease in serum vitamin A levels.
Supplementation at the recommended daily allowance (RDA) of vitamin
A is advised for patients taking ONPATTRO. Higher doses than the
RDA should not be given to try to achieve normal serum vitamin A
levels during treatment with ONPATTRO, as serum levels do not
reflect the total vitamin A in the body.
Patients should be referred to an ophthalmologist if they
develop ocular symptoms suggestive of vitamin A deficiency (e.g.
night blindness).
Adverse Reactions The most common adverse reactions that
occurred in patients treated with ONPATTRO were upper
respiratory-tract infections (29 percent) and infusion-related
reactions (19 percent).
For additional information about ONPATTRO, please see the full
Prescribing Information.
About LNP Technology Alnylam has licenses to Arbutus
Biopharma LNP intellectual property for use in RNAi therapeutic
products using LNP technology.
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 new class of medicines, known as RNAi
therapeutics, is now a reality. 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 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,
hepatic infectious, and central nervous system (CNS)/ocular
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. Alnylam’s first commercial RNAi therapeutic is ONPATTRO®
(patisiran), approved in the U.S., EU, Canada, Switzerland and
Japan. Alnylam has a deep pipeline of investigational medicines,
including five 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 1,200 people worldwide 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.
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, vutrisiran, givosiran, lumasiran, and inclisiran, its
plans for additional global regulatory filings and product launches
for ONPATTRO, as well as an additional clinical study to support
potential label expansion for patisiran, its plans to initiate the
HELIOS-B Phase 3 study for vutrisiran in late 2019, its
expectations regarding the regulatory review of givosiran,
including the PDUFA date set by the FDA, and expectations regarding
the FDA’s current views on not requiring an advisory committee
meeting to discuss the givosiran application, its expectations
regarding the timing of topline results from its ILLUMINATE-A Phase
3 study of lumasiran, its plans to initiate the ILLUMINATE-C Phase
3 study of lumasiran, its expectations regarding the reporting of
results by The Medicines Company from the ORION-9 and ORION-10
studies of inclisiran and the potential filing of an NDA, its
expectations relating to ONPATTRO growth and the expected range of
2019 annual non-GAAP R&D expenses and non-GAAP SG&A
expenses, its expectations regarding the length of time its current
cash, cash equivalents and marketable debt securities will support
company operations based on its current operating plan, plans to
develop a roadmap toward financial self-sustainability, and
expectations regarding 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 its 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, successfully launching, marketing and
selling its approved products globally, Alnylam’s ability to
successfully expand the indication for ONPATTRO in the future,
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 and achieve a
self-sustainable financial profile in the future, 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, including Regeneron, 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.
With the exception of ONPATTRO (patisiran), none of Alnylam’s
investigational therapeutics 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 such investigational
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,
2019
2018
2019
2018
Revenues:
Product revenues, net
$
46,066
$
460
$
110,588
$
460
Net revenue from collaborators
23,995
1,609
37,481
53,415
Total revenues
70,061
2,069
148,069
53,875
Costs and expenses:
Cost of goods sold
$
5,213
$
137
$
12,886
$
137
Research and development
160,796
139,945
453,813
374,384
Selling, general and administrative
120,351
116,545
322,728
273,671
Total costs and expenses
286,360
256,627
789,427
648,192
Loss from operations
(216,299)
(254,558)
(641,358)
(594,317)
Other income (expense):
Interest income
9,889
6,796
26,195
18,691
Other (expense) income
(2,519)
2,925
(2,929)
5,468
Change in fair value of liability
obligation
—
—
9,422
—
Gain on litigation settlement
—
—
—
20,564
Total other income
7,370
9,721
32,688
44,723
Loss before income taxes
(208,929)
(244,837)
(608,670)
(549,594)
Benefit (provision) for income taxes
394
(445)
(1,261)
(462)
Net loss
$
(208,535)
$
(245,282)
$
(609,931)
$
(550,056)
Net loss per common share - basic and
diluted
$
(1.92)
$
(2.43)
$
(5.63)
$
(5.48)
Weighted-average common shares used to
compute basic and diluted net loss per common share
108,701
100,783
108,427
100,430
Comprehensive loss:
Net loss
$
(208,535)
$
(245,282)
$
(609,931)
$
(550,056)
Unrealized (loss) gain on marketable
securities, net of tax
(50)
415
772
1,041
Foreign currency translation
1,439
—
2,281
—
Defined benefit pension plans
71
—
(4,211)
—
Comprehensive loss
$
(207,075)
$
(244,867)
$
(611,089)
$
(549,015)
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,
2019
2018
2019
2018
Reconciliation of GAAP to Non-GAAP
Research and development:
GAAP Research and development
$
160,796
$
139,945
$
453,813
$
374,384
Less: Stock-based compensation
expenses
(22,737)
(45,784)
(54,144)
(67,537)
Non-GAAP Research and development
$
138,059
$
94,161
$
399,669
$
306,847
Reconciliation of GAAP to Non-GAAP
Selling, general and administrative:
GAAP Selling, general and
administrative
$
120,351
$
116,545
$
322,728
$
273,671
Less: Stock-based compensation
expenses
(23,272)
(42,170)
(54,500)
(62,242)
Non-GAAP Selling, general and
administrative
$
97,079
$
74,375
$
268,228
$
211,429
Reconciliation of GAAP to Non-GAAP
Operating expenses:
GAAP Operating expenses
$
286,360
$
256,627
$
789,427
$
648,192
Less: Stock-based compensation
expenses
(46,009)
(87,954)
(108,644)
(129,779)
Non-GAAP Operating expenses
$
240,351
$
168,673
$
680,783
$
518,413
Reconciliation of GAAP to Non-GAAP Net
loss:
GAAP Net loss
$
(208,535)
$
(245,282)
$
(609,931)
$
(550,056)
Add: Stock-based compensation expenses
46,009
87,954
108,644
129,779
Less: Change in fair value of liability
obligation
—
—
(9,422)
—
Less: Gain on litigation settlement
—
—
—
(20,564)
Non-GAAP Net loss
$
(162,526)
$
(157,328)
$
(510,709)
$
(440,841)
Reconciliation of GAAP to Non-GAAP Net
loss per common share-basic and diluted:
GAAP Net loss per common share - basic and
diluted
$
(1.92)
$
(2.43)
$
(5.63)
$
(5.48)
Add: Stock-based compensation expenses
0.42
0.87
1.01
1.29
Less: Change in fair value of liability
obligation
—
—
(0.09)
—
Less: Gain on litigation settlement
—
—
—
(0.20)
Non-GAAP Net loss per common share - basic
and diluted
$
(1.50)
$
(1.56)
$
(4.71)
$
(4.39)
Please note that the figures presented above may not sum exactly
due to rounding
ALNYLAM PHARMACEUTICALS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands,
except share amounts)
September 30,
December 31,
2019
2018
Cash, cash equivalents and marketable debt
securities
$
1,721,058
$
1,082,949
Restricted investments
14,825
44,825
Accounts receivable, net
48,109
18,760
Inventory
54,562
24,068
Prepaid expenses and other assets
83,168
83,542
Property, plant and equipment, net
396,456
320,658
Operating lease right-of-use lease
assets
223,444
—
Total assets
$
2,541,622
$
1,574,802
Accounts payable, accrued expenses and
other liabilities
$
226,376
$
177,392
Total deferred revenue
403,538
3,954
Total deferred rent
—
61,491
Operating lease liability
304,621
—
Long-term debt
—
30,000
Total stockholders’ equity (111.3 million
shares issued and outstanding at September 30, 2019; 101.2 million
shares issued and outstanding at December 31, 2018)
1,607,087
1,301,965
Total liabilities and stockholders'
equity
$
2,541,622
$
1,574,802
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, 2018.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191031005466/en/
Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom
(Investors and Media) 617-682-4340
Josh Brodsky (Investors) 617-551-8276
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