− Achieved First Quarter 2019 ONPATTRO® Global
Net Product Revenues of $26.3 Million with Over 400 Patients on
Commercial Product Worldwide –
− Achieved Positive Results in ENVISION Phase 3
Study of Givosiran –
− Formed Broad Collaboration with Regeneron to
Discover, Develop and Commercialize RNAi Therapeutics Focused on
Ocular and Central Nervous System (CNS) Diseases –
− Strengthened Balance Sheet with New
Equity-Based Capital and Partnership-Based Funding –
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading
RNAi therapeutics company, today reported its consolidated
financial results for the first quarter 2019 and reviewed recent
business highlights.
“The first quarter of 2019 and recent weeks were a remarkable
period of advancement for Alnylam toward our goal of building a
leading biopharmaceutical company. Specifically, we demonstrated
good progress in global commercialization of ONPATTRO, continued
success in our R&D efforts with positive Phase 3 results for
givosiran, and a strong commitment to future pipeline growth
through our landmark ocular and CNS disease alliance with
Regeneron. In addition, we significantly strengthened our balance
sheet through both an equity offering in January and
partnership-based equity funding and cash that we’ll receive upon
closing of the Regeneron transaction,” said John Maraganore, Ph.D.,
Chief Executive Officer of Alnylam. “We believe we are now well
positioned to achieve our Alnylam 2020 goal of building a
multi-product, global biopharma company with a deep clinical
pipeline for future growth and a robust product engine for
sustainable innovation, a profile rarely achieved in our industry.
Moreover, as evidenced by the success of our ONPATTRO launch and
the results of our givosiran Phase 3 study in porphyria, we believe
we’re delivering on our most important goal of bringing potentially
transformative medicines to patients.”
“In the first quarter, we made significant progress in our
global commercialization of ONPATTRO, as we advanced our efforts to
help patients secure access to this important new medicine. With
over 400 patients on commercial product, we’re very pleased with
our team’s launch execution in over 10 countries where ONPATTRO is
now available, and we look forward to continued growth in all
existing and many new countries in the months to come. Of note, we
saw strong new patient demand in the U.S. and EU in the first
quarter, beyond the initial stages of our launch that had been
largely driven by conversion of patients from our expanded access
program as well as patients known to clinical study sites,” said
Barry Greene, President of Alnylam. “As we reported last night, we
believe an important highlight in our commercialization efforts is
the innovation we’ve demonstrated with regard to patient access.
Indeed, with 10 value-based agreements now completed in the U.S.
and with favorable HTA ratings and reimbursement outcomes in key EU
countries, we’re advancing our goal to ensure that ONPATTRO reaches
all patients in need.”
First Quarter 2019 and Recent Significant Corporate
Highlights
Commercial Performance in First Quarter 2019
- Achieved global net product revenues
for the first quarter of 2019 of $26.3 million for ONPATTRO.
- Attained over 400 patients worldwide on
commercial ONPATTRO treatment since launch as of March 31,
2019.
- Received 77 Start Forms in the U.S. in
the first quarter, with over 90 percent from newly identified
patients not previously treated in the ONPATTRO Expanded Access
Program.
- Start Forms in the first quarter came
from a diverse range of prescribing physician specialties,
including 55 percent from cardiologists and 35 percent from
neurologists, with 65 percent of patients covered by Medicare.
- In addition, the Company reports
continued strength in the number of U.S. patients receiving
ONPATTRO from channels outside of its Alnylam Assist patient hub
where the Company does not receive Start Forms.
- Reported continued progress with
value-based agreements (VBAs) with commercial payers in the U.S.
and with market access efforts globally.
- Since launch, Alnylam has achieved
access to ONPATTRO, if prescribed, for greater than 90 percent of
U.S. lives across commercial, Medicare, Medicaid, and other
government payer categories. In addition, Alnylam has completed
definitive VBAs with 10 commercial U.S. payers to date.
- In the EU, Alnylam reported favorable
Health Technology Assessment (HTA) ratings from health authorities
in several countries, including in France (“ASMR III”), Germany
(“considerable benefit”), Italy (“innovation status”), and the
Netherlands where a first-of-its-kind VBA was reached with all
health insurers to reimburse ONPATTRO. The Company remains on track
with pricing and reimbursement procedures in nearly all EU markets,
and encouraging discussions with authorities have progressed
significantly over the quarter.
R&D Highlights
- Advanced patisiran (the non-branded
name for ONPATTRO), an intravenously administered investigational
RNAi therapeutic in development for the treatment of ATTR
amyloidosis.
- Obtained alignment with the U.S. Food
and Drug Administration (FDA) on the design of APOLLO-B, a
randomized, double-blind, placebo-controlled Phase 3 study of
patisiran in hereditary and wild-type ATTR amyloidosis patients
with cardiomyopathy, with the goal of starting the trial in
mid-2019.
- Advanced vutrisiran (ALN-TTRsc02), a
subcutaneously administered investigational RNAi therapeutic in
development for the treatment of ATTR amyloidosis.
- Continued enrollment in the HELIOS-A
Phase 3 study of vutrisiran in hereditary ATTR amyloidosis patients
with plans to initiate additional Phase 3 studies, including in
hereditary and wild-type ATTR amyloidosis cardiomyopathy, in late
2019.
- Advanced givosiran, an investigational
RNAi therapeutic in development for the treatment of acute hepatic
porphyria (AHP).
- Achieved positive results in the
ENVISION Phase 3 study and presented data at the European
Association for the Study of the Liver (EASL) 54th Annual
International Liver Congress.
- On track to complete submission of a
New Drug Application (NDA) and submit a Marketing Authorisation
Application (MAA) for givosiran in mid-2019.
- Advanced lumasiran, an investigational
RNAi therapeutic in development for the treatment of primary
hyperoxaluria type 1 (PH1).
- Continued enrollment in the
ILLUMINATE-A Phase 3 study of lumasiran in PH1 patients aged six or
older with mild-to-moderate renal impairment, and remain on track
to report results by year-end 2019.
- Presented new positive results from the
ongoing Phase 2 open-label extension (OLE) study of lumasiran at
the International Society of Nephrology (ISN) 2019 Annual
Meeting.
- Initiated ILLUMINATE-B, a global Phase
3 pediatric study of lumasiran in PH1 patients under six years of
age.
- Alnylam’s partner, The Medicines
Company, announced in April that the Independent Data Monitoring
Committee for ongoing inclisiran Phase 3 clinical trials (ORION 9,
10, and 11) conducted its sixth planned review of safety and
efficacy data from the ORION trials and recommended that the trials
continue without modification.
- The safety database for inclisiran now
provides more than 3,000 patient-years of exposure to an RNAi
therapeutic, representing the industry’s most comprehensive body of
safety data for an RNA therapeutic.
- Alnylam’s partner, Sanofi, continues
enrollment in the ATLAS Phase 3 program with fitusiran in patients
with hemophilia A or B with and without inhibitors.
- Advanced early- and mid-stage RNAi
clinical pipeline.
- Initiated a Phase 2 study of
cemdisiran, an investigational RNAi therapeutic targeting
complement C5 for the treatment of complement-mediated diseases, in
IgA nephropathy.
- Filed a Clinical Trial Authorisation
(CTA) application and received approval to initiate a Phase 1 study
of ALN-AGT, an investigational RNAi therapeutic targeting
angiotensinogen (AGT) for the treatment of hypertension in high
unmet need populations, including patients with resistant or
refractory hypertension, chronic kidney disease or heart
failure.
Additional Business Highlights
- Announced a broad collaboration with
Regeneron Pharmaceuticals, Inc. to discover, develop, and
commercialize RNAi therapeutics focused on ocular and CNS diseases.
Subject to Hart-Scott-Rodino (HSR) clearance, the Company
anticipates closing this transaction during the second quarter of
2019.
- Announced the conclusion of the
research and option phase of the Company’s 2014 collaboration with
Sanofi focused on advancing RNAi therapeutics for rare genetic
diseases.
- Entered into a collaboration with
23andMe to support the addition of a new Genetic Health Risk report
for Hereditary Amyloidosis (TTR-related), which will help 23andMe
customers who have opted in to receive such reports learn more
about their genetic risk for the three most common TTR variants in
the United States (V122I, V30M, and T60A). Read more about the
report here.
Upcoming Events in Mid-2019
- Alnylam expects to receive regulatory
approvals for ONPATTRO in Japan and Canada.
- Alnylam plans to complete its rolling
NDA submission and file an MAA for givosiran.
- Alnylam expects to complete enrollment
in the ILLUMINATE-A Phase 3 study of lumasiran.
- The Company also expects to initiate
the ILLUMINATE-C Phase 3 study of lumasiran in patients with
impaired renal function.
- Alnylam expects to initiate the
APOLLO-B Phase 3 study of patisiran in hereditary and wild-type
ATTR amyloidosis patients with cardiomyopathy.
- Alnylam’s partner, The Medicines
Company, expects to report initial topline results from the
inclisiran Phase 3 clinical trials in the third quarter.
Financial Results for the Quarter Ended March 31,
2019
“2019 is off to a strong start for Alnylam, as we ended the
first quarter with a balance sheet of $1.3 billion. During the
quarter, our financials were bolstered by encouraging ONPATTRO
uptake as well as proceeds from our January equity financing, and
subsequently enhanced with $800 million in additional cash expected
to be received during the second quarter upon close of our recently
announced collaboration with Regeneron,” said Manmeet Soni, Chief
Financial Officer of Alnylam. “This cash balance positions us for
continued execution of potential commercial launches on a global
scale, while accelerating the advancement of our promising pipeline
of late- and early-stage programs.”
Cash and InvestmentsAt March 31, 2019, Alnylam had cash, cash
equivalents and marketable debt securities and restricted
investments of $1.29 billion, as compared to $1.13 billion at
December 31, 2018.
In January 2019, Alnylam sold an aggregate of 5,000,000 shares
of its common stock through an underwritten public offering at a
price to the public of $77.50 per share. As a result of the
offering, Alnylam received aggregate net proceeds of approximately
$382 million.
Cash at March 31, 2019 excludes proceeds from the Regeneron
collaboration, which was announced after the quarter end and is
subject to customary closing conditions. On a pro forma basis,
Alnylam has cash, cash equivalents and marketable debt securities
and restricted investments of greater than $2 billion.
GAAP and Non-GAAP Net LossThe net loss according to accounting
principles generally accepted in the U.S. (GAAP) for the first
quarter of 2019 was $181.9 million, or $1.73 per share on both a
basic and diluted basis, as compared to a net loss of $141.2
million, or $1.41 per share on both a basic and diluted basis, for
the same period in the previous year.
The non-GAAP net loss for the first quarter of 2019 was $149.9
million, or $1.42 per share on both a basic and diluted basis, as
compared to a non-GAAP net loss of $121.6 million, or $1.22 per
share on both a basic and diluted basis for the same period in the
previous year.
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, NetNet product revenues from sales of
ONPATTRO were $26.3 million in the first quarter of 2019.
Net Revenues from CollaboratorsNet revenues from collaborators
were $7.0 million in the first quarter of 2019 as compared to $21.9
million in the first quarter of 2018.
GAAP and Non-GAAP Research and Development ExpensesGAAP research
and development (R&D) expenses were $129.1 million in the first
quarter of 2019 as compared to $96.9 million in the first quarter
of 2018.
Non-GAAP R&D expenses were $113.0 million in the first
quarter of 2019 as compared to $86.7 million in the first 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
ExpensesGAAP selling, general and administrative (SG&A)
expenses were $89.6 million in the first quarter of 2019 as
compared to $72.4 million in the first quarter of 2018.
Non-GAAP SG&A expenses were $73.7 million in the first
quarter of 2019 as compared to $63.0 million in the first 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 Updated Financial GuidanceAlnylam is updating its
2019 annual non-GAAP R&D expenses to be in the range of $550 to
$590 million and non-GAAP SG&A expenses to be in the range of
$390 to $410 million. Both non-GAAP R&D and non-GAAP SG&A
expenses exclude stock-based compensation expenses. The increase in
non-GAAP R&D guidance of $30 million is due primarily to third
party obligations based on assumed closing of the Regeneron
collaboration during the second quarter.
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 MeasuresThis 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
and the 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 the gain on litigation settlement because
the Company believes this item is a one-time event 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 impacts 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 InformationManagement will provide an
update on the Company and discuss first quarter 2019 results as
well as expectations for the future via conference call on
Wednesday, May 1, 2019 at 8:30 am ET. To access the call, please
dial 800-289-0438 (domestic) or 323-794-2423 (international) five
minutes prior to the start time and refer to conference ID 4935120.
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 719-457-0820 (international) and refer to conference
ID 4935120.
About ONPATTRO® (patisiran)Patisiran, based
on Nobel Prize-winning science, 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. Patisiran 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. In August 2018,
patisiran received FDA approval for the treatment of the
polyneuropathy of hATTR amyloidosis in adults, as well as European
Medicines Agency marketing authorization for the treatment of hATTR
amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy.
Important Safety Information
Infusion-Related ReactionsInfusion-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, paracetamol, 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
SupplementationONPATTRO 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 ReactionsThe most common adverse reactions that
occurred in patients treated with ONPATTRO were respiratory-tract
infection (29 percent) and infusion-related reactions (19
percent).
About LNP TechnologyAlnylam has licenses to Arbutus
Biopharma LNP intellectual property for use in RNAi therapeutic
products using LNP technology.
About RNAiRNAi (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 PharmaceuticalsAlnylam (Nasdaq: ALNY) is
leading the translation of RNA interference (RNAi) into a 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/ocular diseases. Based on
Nobel Prize-winning science, RNAi therapeutics represent a
powerful, clinically validated approach for the treatment of
diseases with high unmet need. ONPATTRO® (patisiran) is the
first-ever RNAi therapeutic approved by the U.S. FDA for the
treatment of the polyneuropathy of hereditary
transthyretin-mediated (hATTR) amyloidosis in adults and by the EMA
for the treatment of hATTR amyloidosis in adults with stage 1 or
stage 2 polyneuropathy. Alnylam has a deep pipeline of
investigational medicines, including six product candidates in
Phase 3 studies. 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. Headquartered in
Cambridge, MA, Alnylam employs over 1,000 people worldwide. For
more information, please visit www.alnylam.com and engage with
us on Twitter at @Alnylam or on LinkedIn.
Alnylam Forward Looking StatementsVarious 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, inclisiran, fitusiran,
cemdisiran, and ALN-AGT, its plans for additional global regulatory
filings and product launches for ONPATTRO, its expectations
regarding the status of pricing and reimbursement procedures
outside the U.S., its expectations regarding the timing for the
initiation of its APOLLO-B Phase 3 study of patisiran, its plans to
initiate additional Phase 3 studies for vutrisiran in late 2019,
its expectations regarding the complete submission of an NDA for
givosiran with the FDA and the filing of an MAA for givosiran with
the EMA, 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 timing of topline results to be reported
by The Medicines Company from the ORION-11, ORION-9 and ORION-10
studies of inclisiran, its 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, its expectations regarding its cash
position following the closing of its alliance with Regeneron and
the expected timing of such closing, 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, 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
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) and in other filings that Alnylam makes with the
SEC. In addition, any forward-looking statements represent
Alnylam's views only as of today and should not be relied upon as
representing its views as of any subsequent date. Alnylam
explicitly disclaims any obligation, 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 EndedMarch
31,
2019 2018
Revenues: Product revenues, net $ 26,291 $ — Net
revenues from collaborators 7,003 21,899
Total revenues 33,294 21,899
Cost and expenses: Cost of goods sold 3,347 —
Research and development 129,127 96,857 Selling, general and
administrative 89,608 72,447 Total
costs and expenses 222,082 169,304 Loss
from operations (188,788 ) (147,405 )
Other income
(expense): Interest income 7,525 5,794 Other income 43
335 Total other income 7,568
6,129 Loss before income taxes (181,220 ) (141,276 )
(Provision) benefit for income taxes (695 ) 62
Net loss $ (181,915 ) $ (141,214 ) Net loss per common share -
basic and diluted $ (1.73 ) $ (1.41 ) Weighted-average common
shares used to compute basic and diluted net loss per common share
105,400 99,979
Comprehensive
loss: Net loss $ (181,915 ) $ (141,214 ) Unrealized gain (loss)
on marketable securities, net of tax 360 (420
) Comprehensive loss $ (181,555 ) $ (141,634 )
ALNYLAM PHARMACEUTICALS,
INC.RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP
MEASURES(In thousands, except per share amounts)
Three Months EndedMarch
31,
2019 2018
Reconciliation of GAAP to Non-GAAP Research and development:
GAAP Research and development $ 129,127 $ 96,857 Less: Stock-based
compensation expenses (16,125 ) (10,137 ) Non-GAAP
Research and development $ 113,002 $ 86,720
Reconciliation of GAAP to Non-GAAP Selling, general and
administrative: GAAP Selling, general and administrative $
89,608 $ 72,447 Less: Stock-based compensation expenses
(15,907 ) (9,447 ) Non-GAAP Selling, general and
administrative $ 73,701 $ 63,000
Reconciliation of GAAP to Non-GAAP Operating costs and
expenses: GAAP Operating costs and expenses $ 222,082 $ 169,304
Less: Stock-based compensation expenses (32,032 )
(19,584 ) Non-GAAP Operating costs and expenses $ 190,050 $
149,720
Reconciliation of GAAP to Non-GAAP Net
loss: GAAP Net loss $ (181,915 ) $ (141,214 ) Add: Stock-based
compensation expenses 32,032 19,584
Non-GAAP Net loss $ (149,883 ) $ (121,630 )
Reconciliation of GAAP to Non-GAAP Net loss per common
share-basic and diluted: GAAP Net loss per common share - basic
and diluted $ (1.73 ) $ (1.41 ) Add: Stock-based compensation
expenses 0.31 0.19 Non-GAAP Net loss
per common share - basic and diluted $ (1.42 ) $ (1.22 )
ALNYLAM PHARMACEUTICALS,
INC.UNAUDITED CONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except share amounts)
March 31,
December 31, 2019
2018 Cash, cash equivalents and marketable
debt securities $ 1,244,537 $ 1,082,949 Restricted investments
44,825 44,825 Accounts receivable, net 33,801 18,760 Inventory
32,001 24,068 Prepaid expenses and other assets 90,711 83,542
Property, plant and equipment, net 341,712 320,658 Operating lease
right-of-use lease assets 226,412
—
Total assets $ 2,013,999
$ 1,574,802 Accounts payable, accrued expenses and
other liabilities $ 134,616 $ 177,392 Total deferred revenue 3,120
3,954 Total deferred rent — 61,491 Long-term debt 30,000 30,000
Total operating lease liability 299,277 — Total stockholders’
equity (106.4 million shares issued and outstanding at March 31,
2019; 101.2 million shares issued and outstanding at December 31,
2018 ) 1,546,986
1,301,965
Total liabilities and stockholders' equity
$ 2,013,999 $ 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/20190501005508/en/
Christine Regan Lindenboom(Investors and Media)617-682-4340
Josh Brodsky(Investors)617-551-8276
Alnylam Pharmaceuticals (NASDAQ:ALNY)
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Alnylam Pharmaceuticals (NASDAQ:ALNY)
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From Sep 2023 to Sep 2024