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): February 11, 2016
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 February 11, 2016, Alnylam Pharmaceuticals, Inc. announced its
financial results for the quarter and year ended December 31, 2015. 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 February 11, 2016.
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: February 11, 2016
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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 February 11, 2016
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Exhibit 99.1
Alnylam
Pharmaceuticals Reports Fourth Quarter and Full Year 2015 Financial
Results and Highlights Recent Period Progress
–
Advanced Pipeline of Eight Clinical Stage Programs in 2015, with Ten or
More Major Clinical Data Readouts, Start of Fitusiran Phase 3 Trials,
and Three New IND Filings Planned in 2016 –
–
Completed Enrollment in Patisiran Phase 3 APOLLO Trial, Positioning the
Company for First Filing for Regulatory Approval in 2017 –
–
Maintained Strong Balance Sheet with $1.28 Billion in Cash and Expects
to End 2016 with Greater than $850 Million in Cash –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 11, 2016--Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics
company, today reported its consolidated financial results for the
fourth quarter and full year 2015, and highlighted recent progress on
its pipeline.
“In 2015, including the fourth quarter, we made strong progress
advancing our pipeline and executing on our broader business objectives.
Through our focused efforts, we grew our pipeline to eight clinical
stage programs, achieved human proof of concept in multiple programs,
and accrued patients in our two pivotal Phase 3 trials, including the
APOLLO study, where we have now completed enrollment,” said John
Maraganore, Ph.D., Chief Executive Officer at Alnylam. “We believe 2016
will be a key year for Alnylam as we expect ten or more clinical data
readouts, the start of two pivotal Phase 3 trials in our fitusiran
hemophilia program, and the filing of three new INDs. In addition, with
our progress in APOLLO, we’re entering the dawn of our commercial
transition with planned regulatory submissions in 2017 for patisiran
approval, if the trial is positive. We believe our 2016 plans place us
firmly on track to achieve our ‘Alnylam 2020’ goals of building a
multi-product, commercial-stage company with a robust and sustainable
pipeline across our three Strategic Therapeutic Areas, or ‘STArs.’”
Fourth Quarter 2015 and Recent Significant Corporate Highlights
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Advanced investigational pipeline programs in Genetic Medicine STAr.
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Advanced RNAi therapeutics programs for the treatment of
transthyrethin (TTR)-mediated amyloidosis (ATTR amyloidosis).
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Completed APOLLO Phase 3 enrollment with 225 patients for
patisiran, in development for patients with Transthyretin
(TTR)-Mediated Amyloidosis (ATTR Amyloidosis).
-
If the study is positive, the Company expects to submit a
New Drug Application (NDA) and Marketing Authorisation
Application (MAA) for patisiran, based on an analysis of
the full APOLLO data set, in late 2017.
-
Reported positive initial 18-month clinical data from
patisiran Phase 2 open-label extension (OLE) study, showing
continued evidence for potential halting of neuropathy
progression. Patisiran was also found to be generally well
tolerated out to nearly two years of drug administration
through the data cutoff date.
-
Complete 18-month clinical data from the patisiran Phase 2
OLE is expected to be reported in an oral session at the
upcoming American Academy of Neurology (AAN) annual
meeting on April 20, 2016, in Vancouver, Canada.
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Continued enrollment in ENDEAVOUR Phase 3 study of revusiran
in ATTR amyloidosis patients with Familial Amyloidotic
Cardiomyopathy (FAC), with data expected in 2018.
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Reported initial 6-month clinical data from revusiran Phase 2
OLE study, showing sustained TTR knockdown representing the
longest dosing experience reported to date for target gene
knockdown with a GalNAc-siRNA conjugate. In majority of
patients, revusiran was generally well tolerated out to 10
months of administration through the data cutoff date.
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Advanced Development Candidate (DC) for ALN-TTRsc02, an
ESC-GalNAc-siRNA conjugate targeting TTR for the treatment of
ATTR amyloidosis, with goal of filing a Clinical Trial
Application (CTA) in early 2016, starting a Phase 1 study in
mid-2016 with initial data in late 2016, and initiating a
Phase 3 trial in 2017.
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Advanced fitusiran (ALN-AT3) for the treatment of hemophilia and
rare bleeding disorders (RBD).
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Presented positive interim data from ongoing Phase 1 trial of
fitusiran.
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Interim results showed that monthly subcutaneous doses
achieved antithrombin (AT) lowering associated with
statistically significant and clinically meaningful
increases in thrombin generation and decreases in bleeding
frequency in patients with hemophilia A and B.
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Fitusiran was also found to be generally well tolerated
through the data cutoff date, including no clinically
significant increases in D-dimer, a biomarker of excessive
clot formation.
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Announced that Sanofi Genzyme elected to opt into the
fitusiran program for development and commercialization
outside of North America and Western Europe, while retaining
its future opt-in right to co-develop and co-promote fitusiran
with Alnylam in North America and Western Europe, subject to
certain restrictions.
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Advanced ALN-CC5 for the treatment of complement-mediated diseases.
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Presented positive initial data from an ongoing Phase 1/2
clinical trial.
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Results showed that ALN-CC5 achieved clinically meaningful
reductions in serum C5 and inhibition of complement
activity.
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ALN-CC5 was also shown to be generally well tolerated,
with no clinically significant, drug-related adverse
events through the data cutoff date.
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Initiated Part C of ongoing Phase 1/2 trial in patients with
paroxysmal nocturnal hemoglobinuria (PNH).
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Advanced ALN-AS1 for the treatment of acute hepatic porphyrias.
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Alnylam announces today that it has enrolled its first patient
in Part C of the ongoing Phase 1 clinical trial. Part C is
being conducted in Acute Intermittent Porphyria (AIP) patients
experiencing multiple recurrent porphyria attacks, and will
evaluate the safety and tolerability of multiple doses of
ALN-AS1 as well as measures of clinical activity, including
reduction in frequency and severity of attack symptoms,
hospitalizations, quality of life, and reduction in the use of
heme and pain medications.
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The Company expects to report initial data from recurrent
attack patients in late 2016 and, if these data are
positive, to initiate a Phase 3 study in 2017.
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Advanced ALN-AAT for the treatment of alpha-1 antitrypsin (AAT)
deficiency-associated liver disease.
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Continued dosing human volunteers in ongoing Phase 1 study.
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Advanced ALN-GO1 for the treatment of primary hyperoxaluria type 1
(PH1).
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Filed CTA to initiate Phase 1 study and obtained approval of
the CTA from U.K. regulatory authorities.
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Alnylam announces today that the United States Food & Drug
Administration (FDA) has granted Orphan Drug Designation to
ALN-GO1 for the treatment of PH1.
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Advanced investigational pipeline programs in Cardio-Metabolic Disease
STAr.
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Advanced ALN-PCSsc for the treatment of hypercholesterolemia.
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Presented positive interim Phase 1 clinical data demonstrating
PCSK9 knockdown and LDL-cholesterol lowering supportive of a
potential bi-annual subcutaneous dose regimen.
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The Medicines Company initiated the Phase 2 ORION-1 trial for
ALN-PCSsc. The trial is expected to recruit 480 patients with
atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-C.
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Advanced investigational pipeline programs in Hepatic Infectious
Disease STAr.
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Completed pre-clinical, IND-enabling studies with ALN-HBV
supporting a CTA filing expected in early 2016.
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Alnylam announces today that in February 2016, Sanofi Genzyme
exercised its right under the investor agreement between Alnylam and
Sanofi Genzyme to purchase 205,030 shares of Alnylam’s common stock
based on the number of shares Alnylam issued for 2015
compensation-related purposes, at $69.75 per share, resulting in
proceeds to Alnylam of $14.3 million.
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The exercise of this right allowed Sanofi Genzyme to maintain its
ownership level of Alnylam common stock of approximately 12
percent.
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Expanded Alnylam’s Management Team and Board of Directors.
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Announced new leadership positions with Alex Leather, M.D., Ph.D.,
General Manager, EU and Canada; Alfred Boyle, Ph.D., Senior Vice
President, Technical Operations; and Akin Akinc, Ph.D. as General
Manager, Fitusiran.
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Announced changes to our Board of Directors including the
appointment of Michael Bonney as Chairman and election of David
Pyott as a Director.
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Presented corporate updates at our R&D Day and the J.P. Morgan Annual
Healthcare Conference, in December and January, respectively, and
provided guidance on notable advances we expect to complete over the
next two years including:
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Ten or more major clinical data readouts in 2016;
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Five or more ongoing Phase 3 trials in 2017; and
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Our first Phase 3 data readout and NDA/MAA submissions in 2017.
(To view presentations of data described above, please visit www.alnylam.com/capella)
Upcoming Events in Early and Mid-2016
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Alnylam announced today that it plans to present the complete 18-month
patisiran OLE data in an oral presentation at the American Academy of
Neurology (AAN) annual meeting on April 20, 2016 in Vancouver, Canada.
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Additional upcoming milestones for Alnylam pipeline programs include:
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In early 2016, Alnylam plans to:
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File a CTA for ALN-TTRsc02;
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Initiate a Phase 1 study for ALN-GO1; and
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File a CTA for ALN-HBV.
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In mid-2016, Alnylam plans to:
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Present 24-month patisiran Phase 2 OLE data;
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Present 12-month revusiran Phase 2 OLE data;
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Start ALN-TTRsc02 Phase 1 study;
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Present additional fitusiran Phase 1 data;
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Start first fitusiran Phase 3 study;
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Present ALN-CC5 Phase 1/2 data in PNH patients;
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Present initial Phase 1 data with ALN-AAT; and
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Start ALN-HBV Phase 1 study.
Financials
“Alnylam continues to maintain a strong balance sheet, ending 2015 with
approximately $1.28 billion in cash,” said Michael Mason, Vice
President, Finance and Treasurer. “Our financial strength allows us to
continue to invest in a broad pipeline of investigational RNAi
therapeutics across our three STArs, aligned with achieving our ‘Alnylam
2020’ goals. As for 2016 financial guidance, we expect to end 2016 with
greater than $850 million in cash.”
Cash, Cash Equivalents and Total Marketable Securities
At December 31, 2015, Alnylam had cash, cash equivalents and total
marketable securities of $1.28 billion, as compared to $881.9 million at
December 31, 2014.
Non-GAAP Net Loss
The non-GAAP net loss for the year ended December 31, 2015 was $290.1
million, or $3.45 per share on both a basic and diluted basis as
compared to a non-GAAP net loss of $139.6 million, or $1.88 per share on
both a basic and diluted basis for the prior year. The non-GAAP net loss
for the year ended December 31, 2014 excludes the $220.8 million charge
to in-process research and development expense in connection with the
purchase of the Sirna RNAi assets from Merck for which there is no
corresponding expense for the year ended December 31, 2015.
GAAP Net Loss
The net loss according to accounting principles generally accepted in
the U.S. (GAAP) for the fourth quarter of 2015 was $90.7 million, or
$1.07 per share on both a basic and diluted basis (including $15.5
million, or $0.18 per share of non-cash stock-based compensation
expense), as compared to a net loss of $21.4 million, or $0.28 per share
on both a basic and diluted basis (including $13.4 million, or $0.17 per
share of non-cash stock-based compensation expense), for the same period
in the previous year. For the year ended December 31, 2015, the net loss
was $290.1 million, or $3.45 per share (including $45.8 million, or
$0.55 per share of non-cash stock-based compensation expense), as
compared to a net loss of $360.4 million, or $4.85 per share (including
$33.1 million, or $0.45 per share of non-cash stock-based compensation
expense), for the prior year. The decrease in net loss for the year
ended December 31, 2015 compared to the prior year resulted primarily
from a $220.8 million charge in 2014 to in-process research and
development expense in connection with the purchase of the Sirna RNAi
assets from Merck.
Revenues
Revenues were $7.6 million for the fourth quarter of 2015, as compared
to $24.0 million for the same period last year. Revenues for the fourth
quarter of 2015 included $3.6 million from the company’s alliance with
Sanofi Genzyme, $2.9 million from the Company’s alliance with The
Medicines Company and $1.1 million from other sources. Revenues were
$41.1 million for the year ended December 31, 2015, as compared to $50.6
million for the prior year. Revenues for the year ended December 31,
2015 included $11.0 million from the company’s alliance with Sanofi
Genzyme, $10.3 million from the company’s alliance with The Medicines
Company, $8.9 million of revenues related to the company’s collaboration
with Takeda, $5.6 million of revenues related to the company’s
collaboration with Monsanto, and $5.3 million from other sources. The
decrease in revenues in the quarter and year ended December 31, 2015
compared to the prior year periods was due primarily to the completion
of the Company’s performance obligations under the Monsanto agreement in
February 2015 and the completion of its revenue amortization under the
Takeda agreement in May 2015, partially offset by higher revenue from
its agreement with Sanofi Genzyme. The company expects net revenues from
collaborators to remain consistent for 2016 as compared to 2015.
Research and Development Expenses
Research and development (R&D) expenses were $82.8 million in the fourth
quarter of 2015 which included $9.3 million of non-cash stock-based
compensation, as compared to $55.5 million in the fourth quarter of
2014, which included $8.2 million of non-cash stock-based compensation.
R&D expenses were $276.5 million for the year ended December 31, 2015,
which included $27.1 million of non-cash stock-based compensation, as
compared to $190.2 million for the prior year, which included $18.2
million of non-cash stock-based compensation. The increase in R&D
expenses for the quarter and year ended December 31, 2015 as compared to
the prior year periods was due primarily to higher clinical trial and
manufacturing and external services expenses resulting primarily from
the significant advancement of the company’s Genetic Medicine pipeline.
In addition, compensation and related expenses increased for the quarter
and year ended December 31, 2015 as compared to the prior year periods
due primarily to a significant increase in headcount during the period
as the company continues to expand and advance its development pipeline.
The Company expects that R&D expenses will increase in 2016 as it
continues to develop its pipeline and advance its product candidates
into clinical trials.
General and Administrative Expenses
General and administrative (G&A) expenses were $17.2 million in the
fourth quarter of 2015, which included $6.3 million of non-cash
stock-based compensation, as compared to $14.2 million in the fourth
quarter of 2014, which included $5.2 million of non-cash stock-based
compensation. G&A expenses were $60.6 million for the year ended
December 31, 2015, which included $18.7 million of non-cash stock-based
compensation, as compared to $44.5 million in 2014, which included $14.8
million of non-cash stock-based compensation. G&A expenses for the
quarter and year ended December 31, 2015 as compared to the prior year
periods increased due primarily to increased non-cash stock-based
compensation and an increase in consulting and professional services
expenses related to an increase in general business activities. The
Company expects that G&A expenses will increase in 2016 as it continues
to grow its operations.
Investment in Regulus Therapeutics
The company accounts for its investment in Regulus at fair value by
adjusting the value to reflect fluctuations in Regulus’ stock price each
reporting period. At December 31, 2015, the fair market value of the
company’s investment in Regulus was $51.4 million as compared to $94.6
million at December 31, 2014.
2016 Financial Guidance
Alnylam expects that its cash, cash equivalents, and total marketable
securities balance will be greater than $850 million at December 31,
2016. This includes approximately $100 million in expenditures related
to Alnylam’s planned capital investment in a drug substance
manufacturing facility.
Conference Call Information
Management will provide an update on the company, discuss fourth quarter
and 2015 results, and discuss expectations for the future via conference
call on Thursday, February 11, 2016 at 4:30 p.m. ET. To access the call,
please dial 877-312-7507 (domestic) or 631-813-4828 (international) five
minutes prior to the start time and refer to conference ID 45176516. A
replay of the call will be available beginning at 7:30 p.m.
ET on February 11, 2016. To access the replay, please dial
855-859-2056 (domestic) or 404-537-3406 (international), and refer to
conference ID 45176516.
Sanofi Genzyme Alliance
In January 2014, Alnylam and Sanofi Genzyme, the specialty care global
business unit of Sanofi, formed an alliance to accelerate and expand the
development and commercialization of RNAi therapeutics across the world.
The alliance is structured as a multi-product geographic alliance in the
field of rare diseases. Alnylam retains product rights in North
America and Western Europe, while Sanofi Genzyme obtained the right to
access certain programs in Alnylam's current and future Genetic
Medicines pipeline in the rest of the world (ROW) through the end of
2019, together with certain broader co-development/co-commercialization
rights and global rights for certain products. In the case of patisiran,
Alnylam will advance the product in North America and Western Europe,
while Sanofi Genzyme will advance the product in the ROW. In the case of
revusiran, Alnylam and Sanofi Genzyme will co-develop/co-commercialize
the product in North America and Western Europe, while Sanofi Genzyme
will advance the product in the ROW. In the case of fitusiran, Sanofi
Genzyme has elected to opt into the program for its ROW rights, while
retaining its further opt-in right to co-develop and co-promote
fitusiran with Alnylam in North America and Western Europe, subject to
certain restrictions.
About RNAi
RNAi (RNA interference) is a revolution in biology, representing a
breakthrough in understanding how genes are turned on and off in cells,
and a completely new approach to drug discovery and development. Its
discovery has been heralded as “a major scientific breakthrough that
happens once every decade or so,” and represents one of the most
promising and rapidly advancing frontiers in biology and drug discovery
today which was awarded the 2006 Nobel Prize for Physiology or Medicine.
RNAi is a natural process of gene silencing that occurs in organisms
ranging from plants to mammals. By harnessing the natural biological
process of RNAi occurring in our cells, the creation of a major new
class of medicines, known as RNAi therapeutics, is on the horizon. Small
interfering RNA (siRNA), the molecules that mediate RNAi and comprise
Alnylam's RNAi therapeutic platform, target the cause of diseases by
potently silencing specific mRNAs, thereby preventing disease-causing
proteins from being made. RNAi therapeutics have the potential to treat
disease and help patients in a fundamentally new way.
About LNP Technology
Alnylam has licenses to Arbutus LNP intellectual property for use in
RNAi therapeutic products using LNP technology.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics
based on RNA interference, or RNAi. The Company is leading the
translation of RNAi as a new class of innovative medicines. Alnylam’s
pipeline of investigational RNAi therapeutics is focused in 3 Strategic
Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of
RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic
Disease, with a pipeline of RNAi therapeutics toward genetically
validated, liver-expressed disease targets for unmet needs in
cardiovascular and metabolic diseases; and Hepatic Infectious Disease,
with a pipeline of RNAi therapeutics that address the major global
health challenges of hepatic infectious diseases. In early 2015, Alnylam
launched its “Alnylam 2020” guidance for the advancement and
commercialization of RNAi therapeutics as a whole new class of
innovative medicines. Specifically, by the end of 2020, Alnylam expects
to achieve a company profile with 3 marketed products, 10 RNAi
therapeutic clinical programs – including 4 in late stages of
development – across its 3 STArs. The Company’s demonstrated commitment
to RNAi therapeutics has enabled it to form major alliances with leading
companies including Merck, Medtronic, Novartis, Biogen, Roche, Takeda,
Kyowa Hakko Kirin, Cubist, GlaxoSmithKline, Ascletis, Monsanto, The
Medicines Company, and Sanofi Genzyme. In addition, Alnylam holds an
equity position in Regulus Therapeutics Inc., a company focused on
discovery, development, and commercialization of microRNA therapeutics.
Alnylam scientists and collaborators have published their research on
RNAi therapeutics in over 200 peer-reviewed papers, including many in
the world’s top scientific journals such as Nature, Nature
Medicine, Nature Biotechnology, Cell, New England Journal of Medicine,
and The Lancet. Founded in 2002, Alnylam maintains headquarters
in Cambridge, Massachusetts and offices in the United Kingdom and
Switzerland. For more information about Alnylam’s pipeline of
investigational RNAi therapeutics, please visit www.alnylam.com.
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam's future
expectations, plans and prospects, including without limitation,
Alnylam's views with respect to the potential for RNAi therapeutics,
including patisiran, revusiran, fitusiran, ALN-CC5, ALN-AS1, ALN-AAT,
ALN-GO1, ALN-PCSsc and ALN-HBV, its expectations regarding its STAr
pipeline growth strategy, its “Alnylam 2020” guidance for the
advancement and commercialization of RNAi therapeutics, its expectations
for the timing of filing of regulatory documents, including but not
limited to IND or CTA submissions for ALN-TTRsc02 and ALN-HBV, and
submission of an MAA and NDA for patisiran, its expectations regarding
the timing of the start of clinical studies and presentation of clinical
data, including its studies for patisiran, revusiran, fitusiran,
ALN-CC5, ALN-AS1, and ALN-AAT, its expected cash position as of December
31, 2016, its expected expenditures related to capital investment in a
drug substance manufacturing facility, and its plans regarding the
pursuit of pre-clinical programs and commercialization of RNAi
therapeutics, constitute forward-looking statements for the purposes of
the safe harbor provisions under The Private Securities Litigation
Reform Act of 1995. Actual results may differ materially from those
indicated by these forward-looking statements as a result of various
important factors, including, without limitation, Alnylam's ability to
discover and develop novel drug candidates and delivery approaches,
successfully demonstrate the efficacy and safety of its drug candidates,
the pre-clinical and clinical results for its product candidates, which
may not be replicated or continue to occur in other subjects or in
additional studies or otherwise support further development of product
candidates, actions of regulatory agencies, which may affect the
initiation, timing and progress of clinical trials, obtaining,
maintaining and protecting intellectual property, Alnylam's ability to
enforce its patents against infringers and defend its patent portfolio
against challenges from third parties, obtaining regulatory approval for
products, competition from others using technology similar to Alnylam's
and others developing products for similar uses, Alnylam's ability to
manage operating expenses, Alnylam's ability to obtain additional
funding to support its business activities and establish and maintain
strategic business alliances and new business initiatives, Alnylam's
dependence on third parties for development, manufacture, marketing,
sales and distribution of products, the outcome of litigation, and
unexpected expenditures, as well as those risks more fully discussed in
the "Risk Factors" filed with Alnylam's most recent Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (SEC) and in
other filings that Alnylam makes with the SEC. In addition, any
forward-looking statements represent Alnylam's views only as of today
and should not be relied upon as representing its views as of any
subsequent date. Alnylam explicitly disclaims any obligation to update
any forward-looking statements.
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ALNYLAM PHARMACEUTICALS, INC.
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UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
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(In thousands, except per share amounts)
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|
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Three Months Ended December 31,
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|
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Year Ended December 31,
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2015
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|
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2014
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2015
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|
|
2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Net revenues from collaborators
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$
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7,551
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$
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24,019
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|
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$
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41,097
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$
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50,561
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|
|
|
|
|
|
|
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Operating expenses:
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|
|
|
|
|
|
|
|
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Research and development (1)
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82,835
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55,546
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|
|
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276,495
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|
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190,249
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In-process research and development
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|
|
—
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|
|
—
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|
|
|
—
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|
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220,766
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General and administrative (1)
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|
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17,228
|
|
|
14,185
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|
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60,610
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|
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44,526
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Total operating expenses
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|
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100,063
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|
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69,731
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|
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337,105
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455,541
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Loss from operations
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|
|
(92,512)
|
|
|
(45,712)
|
|
|
|
(296,008)
|
|
|
(404,980)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
1,616
|
|
|
780
|
|
|
|
5,859
|
|
|
2,559
|
Other income
|
|
|
175
|
|
|
1,452
|
|
|
|
76
|
|
|
1,817
|
Total other income
|
|
|
1,791
|
|
|
2,232
|
|
|
|
5,935
|
|
|
4,376
|
Loss before income taxes
|
|
|
(90,721)
|
|
|
(43,480)
|
|
|
|
(290,073)
|
|
|
(400,604)
|
Benefit from income taxes
|
|
|
—
|
|
|
22,091
|
|
|
|
—
|
|
|
40,209
|
Net loss
|
|
$
|
(90,721)
|
|
$
|
(21,389)
|
|
|
$
|
(290,073)
|
|
$
|
(360,395)
|
Net loss per common share - basic and diluted
|
|
$
|
(1.07)
|
|
$
|
(0.28)
|
|
|
$
|
(3.45)
|
|
$
|
(4.85)
|
Weighted-average common shares used to compute basic and diluted net
loss per common share
|
|
|
84,871
|
|
|
76,957
|
|
|
|
83,992
|
|
|
74,278
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(90,721)
|
|
$
|
(21,389)
|
|
|
$
|
(290,073)
|
|
$
|
(360,395)
|
Unrealized gain (loss) on marketable securities, net of tax
|
|
|
11,588
|
|
|
35,091
|
|
|
|
(44,394)
|
|
|
31,127
|
Reclassification adjustment for realized gain on marketable
securities included in net loss
|
|
|
—
|
|
|
(1,514)
|
|
|
|
—
|
|
|
(2,081)
|
Comprehensive (loss) income
|
|
$
|
(79,133)
|
|
$
|
12,188
|
|
|
$
|
(334,467)
|
|
$
|
(331,349)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Non-cash stock-based compensation expenses included in operating
expenses are as follows:
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
9,257
|
|
$
|
8,214
|
|
|
$
|
27,086
|
|
$
|
18,233
|
General and administrative
|
|
|
6,263
|
|
|
5,224
|
|
|
|
18,697
|
|
|
14,828
|
|
|
|
|
|
|
|
|
|
|
|
ALNYLAM PHARMACEUTICALS, INC.
|
UNAUDITED GAAP TO NON-GAAP RECONCILIATION: NET LOSS AND NET
LOSS PER SHARE
|
(In thousands, except per share amounts)
|
|
|
|
|
Three Months Ended December 31,
|
|
|
Year Ended December 31,
|
|
|
|
2015
|
|
|
2014
|
|
|
|
2015
|
|
|
2014
|
GAAP net loss
|
|
$
|
(90,721)
|
|
$
|
(21,389)
|
|
|
$
|
(290,073)
|
|
$
|
(360,395)
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
220,766
|
Non-GAAP net loss
|
|
$
|
(90,721 )
|
|
$
|
(21,389)
|
|
|
$
|
(290,073)
|
|
$
|
(139,629)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per common share - basic and diluted
|
|
$
|
(1.07)
|
|
$
|
(0.28)
|
|
|
$
|
(3.45)
|
|
$
|
(4.85)
|
Adjustment (as detailed above)
|
|
|
—
|
|
|
—
|
|
|
|
—
|
|
|
2.97
|
Non-GAAP net loss per common share - basic and diluted
|
|
$
|
(1.07)
|
|
$
|
(0.28)
|
|
|
$
|
(3.45)
|
|
$
|
(1.88)
|
|
|
|
|
|
|
|
|
|
|
Use of Non-GAAP Financial Measures
The company supplements its condensed consolidated financial statements
presented on a GAAP basis by providing additional measures that are
considered “non-GAAP” financial measures under applicable SEC rules.
These non-GAAP financial measures are not prepared in accordance with
generally accepted accounting principles in the United States (GAAP) and
should not be viewed in isolation or as a substitute for GAAP net loss
and basic and diluted net loss per common share.
The company evaluates items on an individual basis, and considers both
the quantitative and qualitative aspects of the item, including (i) its
size and nature, (ii) whether or not it relates to the company’s ongoing
business operations, and (iii) whether or not the company expects it to
occur as part of its normal business on a regular basis. In the year
ended December 31, 2014, the company’s Non-GAAP net loss and Non-GAAP
net loss per common share – basic and diluted financial measures exclude
the in-process research and development expense of $220.8 million
related to the purchase of the Sirna RNAi assets from Merck. There will
be no additional charges recorded to in-process research and development
related to this purchase of the Sirna RNAi assets from Merck. The
company believes that the exclusion of this item provides management and
investors with supplemental measures of performance that better reflect
the underlying economics of the company’s business. In addition, the
company believes the exclusion of this item is important in comparing
current results with prior period results and understanding projected
operating performance. Management uses these non-GAAP financial measures
to establish budgets and operational goals and to manage the company’s
business.
|
ALNYLAM PHARMACEUTICALS, INC.
|
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
|
(In thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2015
|
|
|
|
2014
|
Cash, cash equivalents and total marketable securities
|
|
$
|
1,280,951
|
|
|
$
|
881,929
|
Billed and unbilled collaboration receivables
|
|
|
8,298
|
|
|
|
39,937
|
Prepaid expenses and other assets
|
|
|
18,030
|
|
|
|
9,739
|
Deferred tax assets
|
|
|
—
|
|
|
|
31,667
|
Property and equipment, net
|
|
|
27,812
|
|
|
|
21,740
|
Investment in equity securities of Regulus Therapeutics Inc.
|
|
|
51,419
|
|
|
|
94,583
|
Total assets
|
|
$
|
1,386,510
|
|
|
$
|
1,079,595
|
Accounts payable, accrued expenses and other liabilities
|
|
$
|
46,886
|
|
|
$
|
38,791
|
Deferred tax liabilities
|
|
|
—
|
|
|
|
31,667
|
Total deferred revenue
|
|
|
68,317
|
|
|
|
66,854
|
Total deferred rent
|
|
|
6,593
|
|
|
|
6,016
|
Total stockholders’ equity (85.1 million and 77.2 million common
shares issued and outstanding and at December 31, 2015 and December
31, 2014, respectively)
|
|
|
1,264,714
|
|
|
|
936,267
|
Total liabilities and stockholders' equity
|
|
$
|
1,386,510
|
|
|
$
|
1,079,595
|
|
|
|
|
|
|
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Alnylam’s Annual Report on Form 10-K which includes the audited
financial statements for the year ended December 31, 2014.
CONTACT:
Alnylam Pharmaceuticals, Inc.
Investors and Media
Christine
Regan Lindenboom, 617-682-4340
or
Investors
Josh Brodsky,
617-551-8276
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