UNITED STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM 8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 7, 2014
Alnylam
Pharmaceuticals, Inc.
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(Exact
Name of Registrant as Specified in Charter)
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Delaware
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001-36407
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77-0602661
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File
Number)
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(IRS Employer
Identification No.)
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300
Third Street, Cambridge, MA
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02142
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (617) 551-8200
Not applicable
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(Former Name or Former Address, if Changed Since Last Report)
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Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2.
below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition
On August 7, 2014, Alnylam Pharmaceuticals, Inc. announced its financial
results for the quarter ended June 30, 2014. The full text of the press
release issued in connection with the announcement is furnished as
Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Form 8-K (including Exhibit 99.1) shall not be
deemed "filed" for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the "Exchange Act"), or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by
reference in any filing under the Securities Act of 1933, as amended, or
the Exchange Act, except as expressly set forth by specific reference in
such a filing.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
The following exhibit relating to Item 2.02 shall be
deemed to be furnished, and not filed:
99.1 Press Release dated August 7, 2014.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: August 7, 2014
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ALNYLAM
PHARMACEUTICALS, INC.
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By:
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/s/ Michael P. Mason
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Michael P. Mason
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Vice President, Finance and Treasurer
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EXHIBIT INDEX
Exhibit No.
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Description
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99.1
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Press Release dated August 7, 2014
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Exhibit 99.1
Alnylam
Pharmaceuticals Reports Second Quarter 2014 Financial Results and
Highlights Recent Period Activities
–
Achieved Positive Initial Results in Ongoing Phase 2 Open-Label
Extension (OLE) Study with Patisiran, Showing Sustained Clinical
Activity with Transthyretin (TTR) Knockdown at an 80% Target Level and
Tolerability with Extended Dosing –
–
Reported Initial Positive Top-Line Data from Phase 1 Clinical Trial with
ALN-AT3, Demonstrating Statistically Significant Knockdown of
Antithrombin (AT) and Increase in Thrombin Generation –
–
Broadened Pre-Clinical Pipeline with Development Candidates for ALN-CC5
for the Treatment of Complement-Mediated Diseases and ALN-AAT for the
Treatment of Alpha-1 Antitrypsin-Associated Liver Disease; Added ALN-HBV
for the Treatment of Hepatitis B Virus (HBV) Infection as New Program –
–
Presented Pre-clinical Data with ALN-PCSsc Supporting Once-Monthly and
Possibly Once-Quarterly Subcutaneous Dosing Regimen with an RNAi
Therapeutic Targeting PCSK9 for the Treatment of Hypercholesterolemia –
–
Maintained Strong Balance Sheet with $956 Million in Cash and Continues
to Expect to End 2014 with Greater than $825 Million in Cash –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--August 7, 2014--Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics
company, today reported its consolidated financial results for the
second quarter 2014, and company highlights.
“During the second quarter and recent period, we continued to execute on
our expanded ‘Alnylam 5x15’ product development strategy and reported on
multiple significant clinical and pre-clinical data sets. As we continue
enrolling patients in our APOLLO Phase 3 trial with patisiran, we were
pleased to report positive initial data from our ongoing Phase 2
open-label extension (OLE) study, showing sustained knockdown of serum
TTR protein levels in addition to a favorable tolerability profile.
Patients in the OLE study have been treated for up to nine months, and
there have been no discontinuations. Enrollment also continues in our
ALN-TTRsc Phase 2 study in TTR cardiomyopathy and we remain on track to
initiate our Phase 3 trial later this year,” said John Maraganore,
Ph.D., Chief Executive Officer of Alnylam. “Beyond our efforts in TTR
amyloidosis, we were pleased to report positive top-line data with
ALN-AT3, an RNAi therapeutic targeting antithrombin (AT) in development
for the treatment of hemophilia and rare bleeding disorders, showing
that a single, low subcutaneous dose resulted in statistically
significant knockdown of AT, with a corresponding increase in peak
thrombin generation that was temporally associated and consistent with
the degree of target protein knockdown. In aggregate, these latest
results from our clinical pipeline highlight what we believe to be the
significant potential for RNAi therapeutics as a new class of genetic
medicines. We very much look forward to sharing additional updates from
our pipeline in the coming weeks and months, as we enter a data-rich
back half of the year.”
“In addition to advancements in our clinical pipeline, we also made
strong progress with our pre-clinical programs. First, we were pleased
to select our Development Candidate for ALN-CC5 – an RNAi therapeutic
targeting complement C5 for the treatment of complement-mediated
diseases – and we remain on track to file our IND for this program in
late 2014. Our new pre-clinical results with ALN-PCSsc – an RNAi
therapeutic targeting PCSK9 for the treatment of hypercholesterolemia –
highlight the potential for once-monthly or possibly once-quarterly
subcutaneous dosing which we believe has the potential to be disruptive
in a significant emerging market; we expect to file a clinical trial
application (CTA) for ALN-PCSsc later this year. In addition, we
selected a Development Candidate for our ALN-AAT program – an RNAi
therapeutic targeting alpha-1 antitrypsin (AAT) for the treatment of AAT
deficiency associated liver disease – with the goal of filing an IND for
this program in mid-2015, and we added ALN-HBV – an RNAi therapeutic
targeting the hepatitis B viral (HBV) genome for the treatment HBV
infection – as a new program with the goal of filing an IND around
year-end 2015. All of these programs employ our Enhanced Stabilization
Chemistry (ESC) GalNAc-conjugate technology, that enables subcutaneous
dosing with increased potency, durability, and a wide therapeutic index,
and we are very encouraged by the potent knockdown and durability
results emerging from our programs utilizing this improved technology,”
said Barry Greene, President and Chief Operating Officer of Alnylam. “In
addition to these pipeline advancements, we’ve had a very productive
quarter with regard to our intellectual property estate, specifically
with our McSwiggen and Manoharan patent families. These and other
Alnylam-held patents are critical elements of our strategy to bring
important medicines to patients and build value for our shareholders.”
Cash, Cash Equivalents and Total Marketable Securities
At June
30, 2014, Alnylam had cash, cash equivalents and total marketable
securities of $955.9 million, as compared to $350.5 million at December
31, 2013. In February 2014, the company sold to Genzyme 8,766,338 shares
of its common stock and received a cash payment of $700.0 million.
Non-GAAP Net Loss
The non-GAAP net loss for the second quarter
of 2014 was $48.0 million, or $0.63 per share on both a basic and
diluted basis as compared to a non-GAAP net loss of $18.2 million, or
$0.29 per share on both a basic and diluted basis for the same period in
the previous year. The non-GAAP net loss for the second quarter of 2014
excludes the $3.9 million reduction to in-process research and
development expense related to the purchase of the Sirna RNAi assets
from Merck, described below.
GAAP Net Loss
The net loss according to accounting principles
generally accepted in the U.S. (GAAP) for the second quarter of 2014 was
$44.1 million, or $0.58 per share on both a basic and diluted basis
(including $7.7 million, or $0.10 per share of non-cash stock-based
compensation expense), as compared to a net loss of $18.2 million, or
$0.29 per share on both a basic and diluted basis (including $3.4
million, or $0.05 per share of non-cash stock-based compensation
expense), for the same period in the previous year.
Revenues
Revenues were $7.3 million for the second quarter of
2014, as compared to $8.7 million for the same period in the previous
year. Revenues for the second quarter of 2014 included $5.5 million of
revenues from the company’s alliance with Takeda Pharmaceuticals Company
Limited, $1.4 million of revenues related to the company’s collaboration
with Monsanto, and $0.4 million for the company’s alliance with The
Medicines Company, research reagent licenses, and other sources.
Research and Development Expenses
Research and development
(R&D) expenses were $44.7 million in the second quarter of 2014, which
included $2.6 million of non-cash stock-based compensation, as compared
to $24.2 million in the second quarter of 2013, which included $2.2
million of non-cash stock-based compensation. The increase in R&D
expenses in the second quarter of 2014 as compared to the second quarter
of 2013 was due primarily to additional expenses related to the
significant advancement of certain of the company’s clinical and
pre-clinical programs. The company expects that R&D expenses will
increase slightly for the second half of 2014 as certain of our programs
move into late clinical stages.
In-Process Research and Development Expense
In the second
quarter of 2014, the company recorded a reduction of $3.9 million to
in-process research and development expense in connection with the
purchase of the Sirna RNAi assets from Merck. Upon the completion of
certain technology transfer activities in the second quarter of 2014,
the company issued 378,007 shares of common stock to Merck. In the
second quarter of 2014, the company re-measured the expense recorded in
the first quarter of 2014 in connection with these shares using the
price of the company’s common stock on the issuance date. In future
periods, there will be no additional charges recorded to in-process
research and development related to the purchase of the Sirna RNAi
assets from Merck.
General and Administrative Expenses
General and administrative
(G&A) expenses were $11.5 million in the second quarter of 2014, which
included $5.1 million of non-cash stock-based compensation, as compared
to $5.8 million in the second quarter of 2013, which included $1.2
million of non-cash stock-based compensation. The increase in G&A
expenses in the second quarter of 2014 as compared to the second quarter
of 2013 was due primarily to higher non-cash stock-based compensation
expense. Excluding non-cash stock-based compensation expense, the
company expects that G&A expenses will remain consistent for the second
half of 2014.
“Alnylam continues to maintain a very strong balance sheet, ending the
second quarter with $956 million in cash,” said Michael Mason, Vice
President, Finance and Treasurer of Alnylam. “As previously guided, we
remain on track to end 2014 with greater than $825 million in cash. We
believe that this balance sheet allows us to invest in a broad pipeline
of RNAi therapeutics and to maintain financial independence through to
multiple product launches.”
Second Quarter 2014 and Recent Significant Corporate Highlights
Key “Alnylam 5x15” and Genetic Medicine Pipeline Highlights
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Continued to Advance Patisiran (ALN-TTR02) in Development for the
Treatment of Transthyretin (TTR)-Mediated Amyloidosis (ATTR) in
Patients with Familial Amyloidotic Polyneuropathy (FAP).
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Alnylam continues to enroll patients in its APOLLO Phase 3 trial,
with over 20 sites in 9 countries now open and active. The Phase 3
trial is intended to demonstrate the efficacy and safety of
patisiran in support of marketing authorization in countries
around the world.
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At the International Symposium on Amyloidosis (ISA) held April 27
- May 1, 2014 the company presented multiple updates from its
patisiran program. Amongst other data, the company presented
initial positive results from its ongoing Phase 2 open-label
extension (OLE) study. The OLE study is enrolling patients that
were treated in the Phase 2 study and is designed to evaluate the
long-term safety and tolerability of patisiran administration. The
company has now completed enrollment in the study with 27
patients. After up to nine months of therapy, there have been no
study drug discontinuations. The OLE study is measuring a number
of clinical endpoints every six months, including the modified
composite Neuropathy Impairment Score, termed "mNIS+7;" this score
is also the primary endpoint of the Phase 3 APOLLO trial of
patisiran in FAP. Preliminary results from 23 patients showed that
the TTR knockdown observed following the first dose in the OLE
study closely matched TTR knockdown shown in the Phase 2 study,
with essentially superimposable pharmacodynamic effects. Further,
repeat dosing of patisiran led to a sustained TTR knockdown of
approximately 80% through up to day 168, equivalent to up to eight
doses of drug, as measured in pre-dose blood samples. These data
provide the first clinical evidence of sustained, RNAi-mediated
TTR knockdown in FAP patients beyond two doses of patisiran.
Repeat dosing of patisiran was found to be well tolerated, with
minimal adverse events. In addition, the use of a proprietary
micro-dosing infusion regimen was found to significantly reduce
the incidence of infusion-related reactions. Alnylam plans on
reporting initial clinical endpoint data from the OLE study at the
2014 American Neurological Association Annual Meeting, being held
October 12 – 14, 2014 in Baltimore, where the initial dataset is
expected to include 6 month mNIS+7 results from approximately 20
patients.
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In addition, Alnylam and collaborators presented results of a
natural history, cross-sectional analysis study of 283 FAP
patients. These findings showed rapid progression of the
neuropathy impairment score and correlation with disease severity,
providing support for Alnylam's Phase 3 APOLLO trial design.
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Finally, the company presented a pre-clinical update with its ATTR
program. Alnylam scientists presented data confirming that the
degree of TTR knockdown in a mouse disease model was highly
correlated with regression of TTR tissue deposits. Further,
comparative studies were performed with the TTR stabilizer
tafamidis and a TTR-specific antisense oligonucleotide (ASO). In
these pre-clinical studies, RNAi therapeutics targeting TTR were
shown to have superior profiles.
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Alnylam also completed enrollment of 12 healthy volunteers of
Japanese descent in a Phase 1 study with patisiran. This study is
intended to support the expansion of the APOLLO trial to include
sites in Japan.
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Continued Advancement of ALN-TTRsc, a Subcutaneously
Administered RNAi Therapeutic Targeting TTR in Development for the
Treatment of ATTR Patients with Cardiac Amyloidosis. The
company continued enrollment in its pilot Phase 2 study of
ALN-TTRsc. This Phase 2 trial is aimed at evaluating the
tolerability and preliminary clinical activity of ALN-TTRsc in
patients with familial amyloidotic cardiomyopathy (FAC) – which is
caused by autosomal dominant mutations in the TTR gene – or senile
systemic amyloidosis (SSA) – which is caused by idiopathic
accumulation of wild-type TTR in the heart. Based on encouraging
enrollment to date, the protocol for this study was amended to
enroll up to 25 FAC or SSA patients; the previous enrollment
target had been 15. Pending abstract acceptance, the company
expects to present data from the Phase 2 trial at the American
Heart Association Scientific Sessions 2014, being held November 15
– 19, 2014 in Chicago. Patients completing the Phase 2 trial will
be eligible to participate in an OLE study for further assessment
of general tolerability and clinical activity with long-term
dosing; the ALN-TTRsc Phase 2 OLE study is on track to be
initiated in mid-2014. Assuming positive results, Alnylam expects
to begin a Phase 3 trial in TTR cardiac amyloidosis patients by
the end of 2014. In addition, the protocol for the company’s Phase
1 trial with ALN-TTRsc was amended to enroll up to 76 normal human
volunteers; previous target enrollment had been 40 subjects and
results from that study were presented at the Heart Failure
Society of America 17th Annual Scientific Meeting in September
2013. The increase in target enrollment was performed to determine
a fixed (i.e., non-weight-adjusted) dose regimen in support of the
planned Phase 3 trial. Finally, ALN-TTRsc received a positive
opinion for Orphan Drug Designation in Europe.
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Reported Initial Positive Top-Line Data from Phase 1 Clinical Trial
with ALN-AT3, an RNAi Therapeutic Targeting Antithrombin (AT) in
Development for the Treatment of Hemophilia and Rare Bleeding
Disorders (RBD). Results were presented at the World Federation of
Hemophilia (WFH) 2014 World Congress, held May 11 – 15, 2014 in
Melbourne, Australia. In Part A of the Phase 1 study, human volunteer
subjects received a single subcutaneous dose of ALN-AT3 and, per
protocol, the maximum allowable level of AT knockdown was set at 40%.
Initial results from the sole dose cohort enrolled (n=4, 3:1,
drug:placebo) showed that a single, low subcutaneous ALN-AT3 dose at
0.03 mg/kg resulted in an up to 28-32% knockdown of AT at nadir that
was statistically significant relative to placebo (p < 0.01 by ANOVA).
This resulted in a statistically significant (p < 0.01) increase in
peak thrombin generation, that was temporally associated and
consistent with the degree of AT knockdown. ALN-AT3 was found to be
well tolerated with no significant adverse events reported. ALN-AT3 is
the company’s first program to enter clinical development using
Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate
technology, which enables subcutaneous dosing with increased potency,
durability, and a wide therapeutic index. The company has now
transitioned to the Multiple Ascending Dose (MAD) Part B of the study,
which is designed as an open-label, multi-dose, dose-escalation study
enrolling up to 18 people with moderate-to-severe hemophilia A or B.
The primary objective of this part of the study is to evaluate the
safety and tolerability of multiple doses, specifically three doses,
of subcutaneously administered ALN-AT3 in hemophilia subjects.
Secondary objectives include assessment of clinical activity as
determined by knockdown of circulating AT levels and increase in
thrombin generation at pharmacologic doses of ALN-AT3. Assuming
abstract acceptance, Alnylam intends to present initial clinical
results from the Phase 1 study, including all available results in
hemophilia subjects, at the 56th American Society of
Hematology (ASH) Annual Meeting being held December 6 – 9, 2014 in San
Francisco. Finally, Alnylam announced earlier today that ALN-AT3 has
received Orphan Drug Designation in the European Union.
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Advanced Development Candidate for ALN-CC5, a Subcutaneously
Administered RNAi Therapeutic Targeting Complement Component C5 in
Development for the Treatment of Complement-Mediated Diseases. New
results were presented at the 7th International Conference
on Complement Therapeutics, held June 6 - 11, 2014,
in Olympia, Greece, demonstrating that ALN-CC5 led to an up to 98.7%
knockdown of serum C5 and an up to 96.8% inhibition of serum
complement activity in non-human primates (NHPs) with weekly
subcutaneous dose administration. ALN-CC5 utilizes Alnylam’s
ESC-GalNAc-conjugate technology. Assuming abstract acceptance, Alnylam
intends to present additional pre-clinical results from its ALN-CC5
program at the 56th American Society of Hematology (ASH)
Annual Meeting being held December 6 – 9, 2014 in San Francisco. The
company is on track to file its ALN-CC5 IND or IND equivalent in late
2014, and expects to present initial clinical results in mid-2015.
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Presented New Pre-clinical Data on Subcutaneously Delivered RNAi
Therapeutics for Cardio-Metabolic Diseases, including ALN-PCSsc – an
RNAi Therapeutic Targeting PCSK9 in Development for the Treatment of
Hypercholesterolemia – and Added New Program.
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At the Arteriosclerosis, Thrombosis and Vascular Biology (ATVB)
2014 Scientific Sessions, the company presented an update on its
cardio-metabolic disease programs. First, Alnylam presented new
single-dose data for ALN-PCSsc showing robust knockdown of PCSK9
of up to 96% and reduction in LDL-C of up to 77%, in the absence
of statin co-administration. A single dose of ALN-PCSsc maintained
greater than 50% reduction in LDL-C for over three months, a level
of durability that the company believes supports a once-monthly
and possibly once-quarterly subcutaneous dosing regimen. ALN-PCSsc
employs the company’s ESC-GalNAc-conjugate technology. The company
had previously guided that it plans to file an IND or IND
equivalent, for ALN-PCSsc by late 2014 or early 2015; Alnylam is
announcing today that it plans to file a Clinical Trial
Application (CTA) for ALN-PCSsc in late 2014 and expects to
present initial clinical results in mid-2015. The ALN-PCS program
is partnered with The Medicines Company, where, under the terms of
the agreement, Alnylam will complete certain pre-clinical studies
and a Phase 1 clinical study of ALN-PCSsc and The Medicines
Company is responsible for leading and funding development from
Phase 2 forward and commercializing the ALN-PCS program, if
successful.
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In addition, the company presented pre-clinical data from a new
program: ALN-AC3, an RNAi therapeutic targeting apolipoprotein
C-III (apoCIII) for the treatment of hypertriglyceridemia. Alnylam
plans to conduct pre-clinical work in this program to finalize its
Development Candidate.
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Announced Development Candidate for ALN-AAT, an RNAi
Therapeutic Targeting Alpha-1-Antitrypsin (AAT) in Development for
the Treatment of AAT Deficiency-Associated Liver Disease. New
pre-clinical data were presented in a Late-Breaking Abstract
Session at Digestive Disease Week (DDW), held May 3 – 6, 2014 in
Chicago, Illinois. AAT deficiency liver disease is caused by
accumulation of mutant AAT protein (“Z-allele” or “Z-AAT”) in
liver tissue with subsequent liver injury, fibrosis, and, in some
cases, hepatocellular carcinoma. The ALN-AAT Development Candidate
employs Alnylam’s ESC-GalNAc-conjugate technology. Alnylam plans
to initiate IND-enabling studies with the goal of filing an IND or
IND equivalent for ALN-AAT in mid-2015. In addition, Alnylam and
The Alpha-1 Project (TAP), the venture philanthropy subsidiary of
the Alpha-1 Foundation, announced that they have entered into a
collaboration agreement for the continued advancement of ALN-AAT.
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Published Pre-Clinical Results with ALN-AS1, an RNAi Therapeutic
Targeting Aminolevulinic Acid Synthase-1 (ALAS-1) for the Treatment of
Hepatic Porphyrias, in the Proceedings of the National Academy of
Sciences. In the paper, titled "RNAi-mediated silencing of
hepatic Alas1 effectively prevents and treats the induced
acute attacks in acute intermittent porphyria mice," Alnylam
scientists and collaborators at the Icahn School of Medicine at Mount
Sinai in New York City documented results from pre-clinical models of
the human disease showing that RNAi therapeutics targeting ALAS-1 can
completely block the abnormal production of toxic intermediates of the
heme biosynthesis pathway that cause the symptoms and disease
pathology of AIP. Alnylam is currently advancing ALN-AS1, a
subcutaneously administered RNAi therapeutic targeting ALAS-1 for the
treatment of hepatic porphyrias, including acute intermittent
porphyria (AIP). ALN-AS1 utilizes the company's ESC-GalNAc-conjugate
technology. Alnylam expects to file an IND or IND equivalent for
ALN-AS1 in late 2014 or early 2015.
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Advanced ALN-HBV for the Treatment of Hepatitis B Virus (HBV)
Infection. The new ALN-HBV program derives from the
company's January 2014 acquisition of Merck's RNAi assets, including
their Sirna Therapeutics subsidiary. In the most comprehensive
pre-clinical study results presented to date with an RNAi therapeutic
for the treatment of HBV, Alnylam reported significant, multi-log
reductions in HBV surface antigen (HBsAg) and HBV viral titers, and
showed evidence for an immune-mediated therapeutic effect in
chronically infected chimpanzees. Specifically, the new data,
presented at TIDES 2014, held May 12 – 15 in Providence, Rhode Island,
demonstrated an up to 2.3 log10 reduction HBsAg. Alnylam plans to
advance an ESC-GalNAc-siRNA conjugate targeting the HBV genome for its
ALN-HBV program, which should enable once monthly subcutaneous dose
administration with potent and durable effects, and a wide therapeutic
index. The company expects to select a Development Candidate in late
2014 and plans to file an IND or IND equivalent around year end 2015.
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Presented Key Scientific Data on Enhanced ESC-GalNAc-siRNA
Conjugate Technology. Data presented at TIDES 2014 showed that
chemical modifications of siRNA that enhance in vitro stability
result in higher liver exposure in vivo and lead to a
significantly increased potency and durability of effect. As compared
with the “standard template chemistry” (STC)-GalNAc-conjugate approach
used in ALN-TTRsc, ESC-GalNAc-siRNA conjugates demonstrated a 10-fold
increased potency in NHP studies and, based on results with ALN-AT3,
an over 50-fold increased potency in humans. In addition,
ESC-GalNAc-siRNA conjugates demonstrate a durability of knockdown
effect that supports once-monthly or potentially even less frequent
subcutaneous dosing regimens. Finally, ESC-GalNAc-conjugates
demonstrate a wide therapeutic index based on multi-dose toxicology
studies performed in rodents and NHP. This subcutaneous delivery
technology is being used in all Alnylam clinical and pre-clinical
programs with the exception of patisiran and ALN-TTRsc.
Business and Organizational Highlights
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Strengthened Intellectual Property (IP) Estate.
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Alnylam announced that the McSwiggen EP 1423406 ('406) patent was
upheld by the European Patent Office (EPO) in opposition
proceedings. The McSwiggen patent estate comprises a core
component of Alnylam's overall IP estate for the advancement of
RNAi therapeutics, and was recently obtained through the company's
acquisition of Sirna Therapeutics from Merck. The upheld McSwiggen
patent broadly describes chemical modifications of RNAi
therapeutics needed to achieve "drug-like" properties in siRNA,
the molecules that mediate RNAi.
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Alnylam announced that the United States Patent and Trademark
Office (USPTO) issued a patent covering RNAi Therapeutics for the
treatment of HBV infection. The new patent (U.S. patent no.
8,618,277, or "'277 patent") is part of the company's McSwiggen
patent estate. Specifically, the '277 patent includes claims that
the company believes are critical for the development of RNAi
therapeutics for the treatment of HBV infection. This patent is
held exclusively by Alnylam and is not licensed to any third
parties.
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Finally, Alnylam received a Notice of Allowance from the USPTO for
a new patent broadly covering conjugate-based delivery of RNA
therapeutics. The Manoharan et al. patent application
13/693,478, (the “’478 Application”) includes newly allowed claims
directed to compositions including those comprising a modified RNA
agent linked to a biantennary or triantennary ligand.
Specifically, the allowed application includes claims that broadly
cover single-stranded or double-stranded, chemically modified RNA
therapeutics conjugated with an N-acetylgalactosamine (GalNAc)
ligand independent of length, sequence, or disease target.
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Alnylam Added to Russell 1000 Index. The Russell 1000 Index
measures the performance of the large-cap segment of the U.S. equity
universe. It is a subset of the Russell 3000 Index and includes
approximately 1000 of the largest securities based on a combination of
their market cap and current index membership.
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Expanded Board of Directors. Alnylam appointed Amy W. Schulman
to its Board of Directors. Ms. Schulman is the former Executive Vice
President and General Counsel of Pfizer Inc., and served as the
Business Unit Lead for Pfizer's Consumer Healthcare business. She
currently serves on the faculty of Harvard Business School as a Senior
Lecturer. In addition, she is a Venture Partner at Polaris Partners
and the CEO of Arsia Therapeutics, one of Polaris’s early stage
portfolio companies.
Conference Call Information
Management will provide an update
on the company, discuss second quarter 2014 results, and discuss
expectations for the future via conference call on Thursday, August 7,
2014 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 83034261. A replay of
the call will be available beginning at 7:30 p.m. ET on August 7, 2014.
To access the replay, please dial 855-859-2056 (domestic) or
404-537-3406 (international), and refer to conference ID 83034261.
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 GalNAc Conjugates and Enhanced Stabilization Chemistry (ESC)
GalNAc Conjugates
GalNAc-siRNA conjugates are a proprietary
Alnylam delivery platform and are designed to achieve targeted delivery
of RNAi therapeutics to hepatocytes through uptake by the
asialoglycoprotein receptor. Alnylam’s Enhanced Stabilization Chemistry
(ESC) GalNAc-conjugate technology enables subcutaneous dosing with
increased potency, durability, and a wide therapeutic index, and is
being employed in several of Alnylam’s genetic medicine programs,
including programs in clinical development.
About LNP Technology
Alnylam has licenses to Tekmira 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 with a core focus on RNAi therapeutics as genetic
medicines, including programs as part of the company’s “Alnylam 5x15™”
product strategy. Alnylam’s genetic medicine programs are RNAi
therapeutics directed toward genetically defined targets for the
treatment of serious, life-threatening diseases with limited treatment
options for patients and their caregivers. These include: patisiran
(ALN-TTR02), an intravenously delivered RNAi therapeutic targeting
transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR)
in patients with familial amyloidotic polyneuropathy (FAP); ALN-TTRsc, a
subcutaneously delivered RNAi therapeutic targeting TTR for the
treatment of ATTR in patients with TTR cardiac amyloidosis, including
familial amyloidotic cardiomyopathy (FAC) and senile systemic
amyloidosis (SSA); ALN-AT3, an RNAi therapeutic targeting antithrombin
(AT) for the treatment of hemophilia and rare bleeding disorders (RBD);
ALN-CC5, an RNAi therapeutic targeting complement component C5 for the
treatment of complement-mediated diseases; ALN-AS1, an RNAi therapeutic
targeting aminolevulinic acid synthase-1 (ALAS-1) for the treatment of
hepatic porphyrias including acute intermittent porphyria (AIP);
ALN-PCS, an RNAi therapeutic targeting PCSK9 for the treatment of
hypercholesterolemia; ALN-AAT, an RNAi therapeutic targeting alpha-1
antitrypsin (AAT) for the treatment of AAT deficiency-associated liver
disease; ALN-TMP, an RNAi therapeutic targeting TMPRSS6 for the
treatment of beta-thalassemia and iron-overload disorders; ALN-ANG, an
RNAi therapeutic targeting angiopoietin-like 3 (ANGPTL3) for the
treatment of genetic forms of mixed hyperlipidemia and severe
hypertriglyceridemia; ALN-AC3, an RNAi therapeutic targeting
apolipoprotein C-III (apoCIII) for the treatment of
hypertriglyceridemia; and other programs yet to be disclosed. As part of
its “Alnylam 5x15” strategy, as updated in early 2014, the company
expects to have six to seven genetic medicine product candidates in
clinical development - including at least two programs in Phase 3 and
five to six programs with human proof of concept - by the end of 2015.
Alnylam is also developing ALN-HBV, an RNAi therapeutic targeting the
hepatitis B virus (HBV) genome for the treatment of HBV infection. The
company’s demonstrated commitment to RNAi therapeutics has enabled it to
form major alliances with leading companies including Merck, Medtronic,
Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist,
GlaxoSmithKline, Ascletis, Monsanto, The Medicines Company, and Genzyme,
a Sanofi company. In March 2014, Alnylam acquired Sirna Therapeutics, a
wholly owned subsidiary of Merck. 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, the New
England Journal of Medicine, and The Lancet. Founded in 2002,
Alnylam maintains headquarters in Cambridge, Massachusetts. For more
information, please visit www.alnylam.com.
About “Alnylam 5x15™” and Genetic Medicines
The
“Alnylam 5x15” strategy, launched in January 2011, establishes a path
for development and commercialization of novel RNAi therapeutics as
genetic medicines. Alnylam’s genetic medicine programs are RNAi
therapeutics directed toward genetically defined targets for the
treatment of diseases with high unmet medical need. These programs share
several key characteristics including: a genetically defined target and
disease expressed in the liver; the potential to have a major impact in
a high unmet need population; the ability to leverage the existing
Alnylam RNAi platform with clinically proven delivery to the liver; the
opportunity to monitor an early biomarker in Phase 1 clinical trials for
human proof of concept; and the existence of clinically relevant
endpoints for the filing of a new drug application (NDA) with a focused
patient database and possible accelerated paths for commercialization.
As updated in early 2014, the company expects to have six to seven
genetic medicine product candidates in clinical development – including
at least two programs in Phase 3 and five to six programs with human
proof of concept – by the end of 2015. The “Alnylam 5x15” programs
include: patisiran (ALN-TTR02), an intravenously delivered RNAi
therapeutic targeting transthyretin (TTR) in development for the
treatment of TTR-mediated amyloidosis (ATTR) in patients with familial
amyloidotic polyneuropathy (FAP); ALN-TTRsc, a subcutaneously delivered
RNAi therapeutic targeting TTR in development for the treatment of ATTR
in patients with TTR cardiac amyloidosis, including familial amyloidotic
cardiomyopathy (FAC) and senile systemic amyloidosis (SSA); ALN-AT3, an
RNAi therapeutic targeting antithrombin (AT) in development for the
treatment of hemophilia and rare bleeding disorders (RBD); ALN-CC5, an
RNAi therapeutic targeting complement component C5 in development for
the treatment of complement-mediated diseases; ALN-AS1, an RNAi
therapeutic targeting aminolevulinic acid synthase-1 (ALAS-1) in
development for the treatment of hepatic porphyrias including acute
intermittent porphyria (AIP); ALN-PCS, an RNAi therapeutic targeting
PCSK9 in development for the treatment of hypercholesterolemia; ALN-AAT,
an RNAi therapeutic targeting alpha-1 antitrypsin (AAT) for the
treatment of AAT deficiency-associated liver disease; ALN-TMP, an RNAi
therapeutic targeting TMPRSS6 in development for the treatment of
beta-thalassemia and iron-overload disorders; ALN-ANG, an RNAi
therapeutic targeting angiopoietin-like 3 (ANGPTL3) for the treatment of
genetic forms of mixed hyperlipidemia and severe hypertriglyceridemia;
ALN-AC3, a subcutaneously administered RNAi therapeutic targeting
apolipoprotein C-III (apoCIII) for the treatment of
hypertriglyceridemia; and other programs yet to be disclosed. In 2014,
Alnylam and Genzyme, a Sanofi company, formed a multi-product geographic
alliance on Alnylam's genetic medicine programs. Specifically, Alnylam
will lead development and commercialization of programs in North America
and Europe, while Genzyme will develop and commercialize products in the
rest of world. In addition, Alnylam and Genzyme will co-develop and
co-commercialize ALN-TTRsc in North America and Europe.
Use of Non-GAAP Financial Measures
Alnylam has presented in
this press release certain non-GAAP financial measures, including
non-GAAP net loss and non-GAAP net loss per common share – basic and
diluted. A reconciliation between these non-GAAP financial measures and
the most comparable GAAP financial measures are included in the tables
accompanying 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 expectations regarding its
“Alnylam 5x15” product strategy, Alnylam’s views with respect to the
potential for RNAi therapeutics, including patisiran (ALN-TTR02) and
ALN-TTRsc, ALN-AT3, ALN-CC5, ALN-AS1, ALN-PCSsc, ALN-AAT, ALN-TMP,
ALN-ANG, ALN-AC3, and ALN-HBV, its expectations with respect to the
timing, execution, and success of its clinical and pre-clinical trials,
the expected timing of regulatory filings, including its plan to file
IND or IND equivalent applications and/or initiate clinical trials for
ALN-TTRsc, ALN-CC5, ALN-PCSsc, ALN-AS1, ALN-AAT, and ALN-HBV, its
expectations regarding reporting of data from its clinical and
pre-clinical studies, including its studies for patisiran, ALN-TTRsc,
ALN-AT3, and ALN-CC5, as well as other research programs and
technologies, its plans regarding commercialization of RNAi
therapeutics, Genzyme’s and The Medicines Company’s participation in the
development and commercialization of RNAi therapeutics, Alnylam’s views
with respect to the potential value of the assets acquired from Merck
and its ability to further its efforts to build a new class of
medicines, its expected cash position as of December 31, 2014, and its
expectations regarding available cash for its operations through to
multiple product launches, constitute forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995. Actual results may differ materially from
those indicated by these forward-looking statements as a result of
various important factors, including, without limitation, Alnylam’s
ability to manage operating expenses, Alnylam’s ability to discover and
develop novel drug candidates and delivery approaches, successfully
demonstrate the efficacy and safety of its drug candidates, the
pre-clinical and clinical results for its product candidates, which may
not support further development of product candidates, actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials, obtaining, maintaining and protecting
intellectual property, Alnylam’s ability to enforce its patents against
infringers and defend its patent portfolio against challenges from third
parties, obtaining regulatory approval for products, competition from
others using technology similar to Alnylam’s and others developing
products for similar uses, Alnylam’s ability to obtain additional
funding to support its business activities and establish and maintain
strategic business alliances and new business initiatives, Alnylam’s
dependence on third parties for development, manufacture, marketing,
sales and distribution of products, the outcome of litigation, and
unexpected expenditures, as well as those risks more fully discussed in
the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC) and in
other filings that Alnylam makes with the SEC. In addition, any
forward-looking statements represent Alnylam’s views only as of today
and should not be relied upon as representing its views as of any
subsequent date. Alnylam explicitly disclaims any obligation to update
any forward-looking statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC.
|
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|
|
Six Months Ended
June 30,
|
|
|
|
|
2014
|
|
|
2013
|
|
|
|
2014
|
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues from collaborators
|
|
|
|
$
|
7,295
|
|
|
$
|
8,687
|
|
|
|
$
|
15,570
|
|
|
$
|
27,329
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1)
|
|
|
|
|
44,672
|
|
|
|
24,215
|
|
|
|
|
88,430
|
|
|
|
46,394
|
In-process research and development
|
|
|
|
|
(3,890)
|
|
|
|
—
|
|
|
|
|
220,766
|
|
|
|
—
|
General and administrative (1)
|
|
|
|
|
11,518
|
|
|
|
5,784
|
|
|
|
|
20,443
|
|
|
|
12,051
|
Total operating expenses
|
|
|
|
|
52,300
|
|
|
|
29,999
|
|
|
|
|
329,639
|
|
|
|
58,445
|
Loss from operations
|
|
|
|
|
(45,005)
|
|
|
|
(21,312)
|
|
|
|
|
(314,069)
|
|
|
|
(31,116)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
693
|
|
|
|
270
|
|
|
|
|
1,026
|
|
|
|
494
|
Other expense
|
|
|
|
|
(77)
|
|
|
|
(11)
|
|
|
|
|
(159)
|
|
|
|
(6)
|
Total other income
|
|
|
|
|
616
|
|
|
|
259
|
|
|
|
|
867
|
|
|
|
488
|
Loss before income taxes
|
|
|
|
|
(44,389)
|
|
|
|
(21,053)
|
|
|
|
|
(313,202)
|
|
|
|
(30,628)
|
Benefit from income taxes
|
|
|
|
|
315
|
|
|
|
2,884
|
|
|
|
|
18,185
|
|
|
|
3,446
|
Net loss
|
|
|
|
$
|
(44,074)
|
|
|
$
|
(18,169)
|
|
|
|
$
|
(295,017)
|
|
|
$
|
(27,182)
|
Net loss per common share - basic and diluted
|
|
|
|
$
|
(0.58)
|
|
|
$
|
(0.29)
|
|
|
|
$
|
(4.11)
|
|
|
$
|
(0.45)
|
Weighted average common shares used to compute basic and diluted net
loss per common share
|
|
|
|
|
75,835
|
|
|
|
61,661
|
|
|
|
|
71,833
|
|
|
|
60,424
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(44,074)
|
|
|
$
|
(18,169)
|
|
|
|
$
|
(295,017)
|
|
|
$
|
(27,182)
|
Unrealized (loss) gain on marketable securities, net of tax
|
|
|
|
|
(3,047)
|
|
|
|
7,309
|
|
|
|
|
2,266
|
|
|
|
12,468
|
Comprehensive loss
|
|
|
|
$
|
(47,121)
|
|
|
$
|
(10,860)
|
|
|
|
$
|
(292,751)
|
|
|
$
|
(14,714)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Non-cash stock-based compensation expenses included in
operating expenses are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$
|
2,557
|
|
|
$
|
2,200
|
|
|
|
$
|
6,238
|
|
|
$
|
4,287
|
General and administrative
|
|
|
|
|
5,123
|
|
|
|
1,177
|
|
|
|
|
7,033
|
|
|
|
2,165
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC.
|
UNAUDITED GAAP TO NON-GAAP RECONCILIATION: NET LOSS AND NET LOSS
PER SHARE
|
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
|
|
Six Months Ended
June 30,
|
|
|
|
|
2014
|
|
|
2013
|
|
|
|
2014
|
|
|
2013
|
GAAP net loss
|
|
|
|
$
|
(44,074)
|
|
|
$
|
(18,169)
|
|
|
|
$
|
(295,017)
|
|
|
$
|
(27,182)
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
|
|
|
|
(3,890)
|
|
|
|
—
|
|
|
|
|
220,766
|
|
|
|
—
|
Non-GAAP net loss
|
|
|
|
$
|
(47,964)
|
|
|
$
|
(18,169)
|
|
|
|
$
|
(74,251)
|
|
|
$
|
(27,182)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per common share - basic and diluted
|
|
|
|
$
|
(0.58)
|
|
|
$
|
(0.29)
|
|
|
|
$
|
(4.11)
|
|
|
$
|
(0.45)
|
Adjustment (as detailed above)
|
|
|
|
|
(0.05)
|
|
|
|
—
|
|
|
|
|
3.08
|
|
|
|
—
|
Non-GAAP net loss per common share - basic and diluted
|
|
|
|
$
|
(0.63)
|
|
|
$
|
(0.29)
|
|
|
|
$
|
(1.03)
|
|
|
$
|
(0.45)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Use of Non-GAAP Financial Measures
The company supplements its condensed consolidated financial statements
presented on a GAAP basis by providing additional measures that are
considered “non-GAAP” financial measures under applicable SEC rules.
These non-GAAP financial measures are not prepared in accordance with
generally accepted accounting principles in the United States (GAAP) and
should not be viewed in isolation or as a substitute for GAAP net loss
and basic and diluted net loss per common share.
The company evaluates items on an individual basis, and considers both
the quantitative and qualitative aspects of the item, including (i) its
size and nature, (ii) whether or not it relates to the company’s ongoing
business operations, and (iii) whether or not the company expects it to
occur as part of its normal business on a regular basis. In the second
quarter of 2014 and first half of 2014, the company’s Non-GAAP net loss
and Non-GAAP net loss per common share – basic and diluted financial
measures excludes the in-process research and development reduction to
expense of $3.9 million and expense of $220.8 million, respectively,
related to the purchase of the Sirna RNAi assets from Merck. The company
believes that the exclusion of this item provides management and
investors with supplemental measures of performance that better reflect
the underlying economics of the company’s business. In addition, the
company believes the exclusion of this item is important in comparing
current results with prior period results and understanding projected
operating performance. Management uses these non-GAAP financial measures
to establish budgets and operational goals and to manage the company’s
business.
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC.
|
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
|
(In thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
|
December 31,
|
|
|
|
|
2014
|
|
|
2013
|
Cash, cash equivalents and total marketable securities
|
|
|
|
$955,897
|
|
|
$350,472
|
Billed and unbilled collaboration receivables
|
|
|
|
89
|
|
|
4,248
|
Prepaid expenses and other current assets
|
|
|
|
10,270
|
|
|
3,910
|
Property and equipment, net
|
|
|
|
16,953
|
|
|
16,448
|
Investment in equity securities of Regulus Therapeutics Inc.
|
|
|
|
49,450
|
|
|
45,452
|
Total assets
|
|
|
|
$1,032,659
|
|
|
$420,530
|
Accounts payable, accrued expenses and other liabilities
|
|
|
|
$27,032
|
|
|
$20,056
|
Total deferred revenue
|
|
|
|
59,550
|
|
|
126,090
|
Total deferred rent
|
|
|
|
3,808
|
|
|
4,037
|
Total stockholders’ equity (76.3 million and 63.7 million common
shares issued and outstanding and at June 30, 2014 and December 31,
2013, respectively)
|
|
|
|
942,269
|
|
|
270,347
|
Total liabilities and stockholders' equity
|
|
|
|
$1,032,659
|
|
|
$420,530
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Alnylam’s Annual Report on Form 10-K which includes the audited
financial statements for the year ended December 31, 2013.
CONTACT:
Alnylam Pharmaceuticals, Inc.
Cynthia Clayton,
617-551-8207
Vice President, Investor Relations and Corporate
Communications
or
Michael Mason, 617-551-8327
Vice President,
Finance and Treasurer
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