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 12, 2015
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 12, 2015, Alnylam Pharmaceuticals, Inc. announced its
financial results for the quarter and year ended December 31, 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 February 12, 2015.
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 12, 2015
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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 12, 2015
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Exhibit 99.1
Alnylam
Pharmaceuticals Reports Fourth Quarter and Full Year 2014 Financial
Results and Highlights Recent Period Progress
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Introduced Pipeline Growth Strategy for RNAi Therapeutics in Three
Strategic Therapeutic Areas, or “STArs,” and Launched “Alnylam 2020”
Guidance for Advancement and Commercialization of RNAi Therapeutics –
–
Presented Positive Data from Multiple Clinical Programs, Including
Initial Evidence of Potential Disease Modifying Effects with Patisiran
and ALN-AT3 –
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Advanced Revusiran into ENDEAVOUR Phase 3 Trial and Added Three New
Programs into Clinical Stages –
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Maintained Strong Balance Sheet with $882 Million in Cash and Expects to
End 2015 with Greater than $1.2 Billion in Cash –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 12, 2015--Alnylam
Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics
company, today reported its consolidated financial results for the
fourth quarter and full year 2014, and highlighted recent progress in
advancing its pipeline.
“Alnylam made excellent progress in the fourth quarter of 2014 and the
recent period, as we continued advancing RNAi therapeutics in clinical
studies. Amongst other highlights, we reported clinical data from our
patisiran and ALN-AT3 programs showing what we believe to be early
evidence for the translation of RNAi-mediated knockdown into potential
clinical benefit for patients. We also executed on our pipeline goals,
with strong enrollment in our patisiran APOLLO Phase 3 study and
advancement of revusiran into our ENDEAVOUR Phase 3 trial. In addition,
we filed three Clinical Trial Applications for ALN-PCSsc, ALN-CC5, and
ALN-AS1, and have initiated Phase 1 studies for two of those programs,”
said John Maraganore, Ph.D., Chief Executive Officer of Alnylam.
“Alnylam also introduced its pipeline growth strategy and new guidance.
Specifically, Alnylam intends to advance its pipeline in three Strategic
Therapeutic Areas, or ‘STArs’ – Genetic Medicines, Cardio-Metabolic
Disease, and Hepatic Infectious Disease – where we believe there are
significant opportunities for RNAi therapeutics as high impact
medicines. Further, with ‘Alnylam 2020’ we have launched new guidance
that marks our expected transition from a late-stage clinical
development company to a multi-product commercial-stage company with a
sustainable development pipeline – a profile that we believe has rarely
been achieved in the biopharmaceutical industry.”
“Alnylam continues to maintain a very strong balance sheet, ending 2014
with approximately $882 million in cash,” said Michael Mason, Vice
President, Finance & Treasurer. “We also further strengthened our
balance sheet earlier this year with a public offering and concurrent
private placements from Genzyme that resulted in net proceeds of
approximately $567 million. This financing results in a balance sheet
that allows us to invest in a broad pipeline of RNAi therapeutics across
all three STArs, which we believe should enable us to achieve our
‘Alnylam 2020’ guidance. As for financial guidance this year, we expect
to end 2015 with greater than $1.2 billion in cash.”
Fourth Quarter 2014 and Recent Significant Corporate Highlights
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Introduced pipeline growth strategy for RNAi therapeutics in three
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 dyslipidemia, hypertension, non-alcoholic steatohepatitis (NASH),
and type 2 diabetes; and Hepatic Infectious Disease, with a pipeline
of RNAi therapeutics that address the major global health challenges
of hepatic infectious diseases.
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Launched “Alnylam 2020” Guidance for advancement and intended
commercialization of RNAi Therapeutics. 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.
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Advanced pipeline programs in Genetic Medicine STAr.
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Advanced investigational RNAi therapeutic programs for the
treatment of transthyretin (TTR)-mediated amyloidosis (ATTR).
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Continued enrollment in APOLLO Phase 3 study of patisiran in
ATTR patients with Familial Amyloidotic Polyneuropathy (FAP)
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Reported positive six-month clinical data from patisiran Phase
2 open-label extension (OLE) study, showing tolerability,
sustained TTR knockdown, and promising initial evidence for
potential stabilization of neuropathy progression.
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Initiated ENDEAVOUR Phase 3 study with revusiran. ENDEAVOUR is
a randomized, double-blind, placebo-controlled, global study
designed to evaluate the efficacy and safety of revusiran in
ATTR patients with Familial Amyloidotic Cardiomyopathy (FAC).
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Presented positive initial Phase 2 data with revusiran, with
up to 98.2% knockdown of serum TTR; revusiran administration
was found to be generally well tolerated in patients with
advanced cardiac disease.
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Initiated Phase 2 OLE study with revusiran to evaluate
tolerability and clinical activity with long-term dosing for
up to two years.
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Reported positive initial results from Phase 1 trial of ALN-AT3,
including initial evidence for the potential correction of the
hemophilia phenotype with an up to 334% increase in thrombin
generation and marked improvement in whole blood clotting.
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Initiated Phase 1/2 trial with ALN-CC5. The trial is being
conducted initially in normal human volunteers, and then in
patients with paroxysmal nocturnal hemoglobinuria (PNH).
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Filed Clinical Trial Application (CTA) to initiate a Phase 1 trial
with ALN-AS1 in acute intermittent porphyria (AIP) patients who
are asymptomatic “high excreters” (ASHE), and then in AIP patients
who experience recurrent porphyria attacks.
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Expanded Genetic Medicine pipeline with ALN-GO1, an
investigational RNAi therapeutic targeting glycolate oxidase (GO)
in development for the treatment of Primary Hyperoxaluria Type 1
(PH1).
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Advanced pipeline programs in Cardio-Metabolic Disease STAr
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Initiated Phase 1 trial with ALN-PCSsc in normal human volunteers
with elevated LDL-C at baseline.
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Advanced pipeline programs in Hepatic Infectious Disease STAr
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Selected Development Candidate (DC) for ALN-HBV, showing an up to
3.9 log10 knockdown of hepatitis surface antigen
(HBsAg) after a single subcutaneous dose in a rodent model of HBV
infection.
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Expanded Hepatic Infectious Disease pipeline with ALN-HDV for
Hepatitis Delta Virus (HDV) infection and ALN-PDL for chronic
liver infections.
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Formed new agreement with Isis Pharmaceuticals, extending the
companies’ decade-long alliance to lead the development and
commercialization of RNA therapeutics.
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Completed successful public offering of common stock, with concurrent
private placements from Genzyme, totaling $567 million in net proceeds.
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Announced changes to Board of Directors and Management Team
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Alnylam elected Michael W. Bonney to its Board of Directors.
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Alnylam announces today certain promotions and appointments,
including:
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Akshay Vaishnaw, M.D., Ph.D. to the position of Executive Vice
President of Research & Development and Chief Medical Officer
from the position of Executive Vice President, Chief Medical
Officer.
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Rachel Meyers, Ph.D. to the position of Senior Vice President
of Research from the position of Vice President of Research &
RNAi Lead Development.
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Kevin Fitzgerald, Ph.D. to the position of Vice President of
Research from the position of Senior Director of Research.
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Pushkal Garg, M.D. to the position of Senior Vice President,
Clinical Development.
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Eric Green to the position of Vice President, General Manager,
TTR Program.
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Marcie Ruddy, M.D. to the position of Vice President, Drug
Safety & Pharmacovigilance.
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In addition, Alnylam announced the planned departure of Laurence
Reid, Ph.D., who held the position of Senior Vice President, Chief
Business Officer.
Upcoming Events in Early and Mid-2015
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Alnylam announces today that it plans to present 12-month OLE study
data with patisiran at the American Academy of Neurology 67th
Annual Meeting, being held April 18 – 25, 2015 in Washington, D.C., in
an oral presentation on Tuesday, April 21 at 1:30 p.m. ET.
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The company also announces today that it plans to present additional
clinical results from the Phase 2 trial of revusiran at the American
College of Cardiology (ACC) 64th Annual Scientific Session
& Expo, being held March 14 – 16, 2015 in San Diego, California, in a
poster presentation on Sunday, March 15 at 1:30 p.m. PT (4:30 p.m. ET).
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Also at the ACC meeting, Alnylam plans to present results of a natural
history study of patients with TTR cardiac amyloidosis in a meeting
with clinicians from the Association of Black Cardiologists on Sunday,
March 15.
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In addition, during early and mid-2015, Alnylam plans to:
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Present additional data from Phase 1 trial of ALN-AT3 in
development for the treatment of hemophilia and rare bleeding
disorders
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Present initial data from the Phase 1/2 trial of ALN-CC5 in
development for the treatment of complement-mediated diseases
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Initiate Phase 1 trial of ALN-AS1 in development for the treatment
of hepatic porphyrias
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Present initial data from Phase 1 trial of ALN-PCSsc in
development for the treatment of hypercholesterolemia
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File CTA for ALN-AAT in development for the treatment of alpha-1
antitrypsin (AAT) deficiency-associated liver disease
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Select DC for ALN-GO1 in development for the treatment of PH1
Financials
Cash, Cash Equivalents and Total Marketable Securities
At December 31, 2014, Alnylam had cash, cash equivalents and total
marketable securities of $881.9 million, as compared to $350.5 million
at December 31, 2013.
In January 2015, Alnylam sold an aggregate of 5,447,368 shares of its
common stock through an underwritten public offering at a price to the
public of $95.00 per share. As a result of the offering, Alnylam
received aggregate net proceeds of approximately $496.4 million.
In January 2015, in connection with our public offering described above,
Genzyme exercised its right under the investor agreement between Alnylam
and Genzyme, to purchase, in concurrent private placements, 744,566
shares of common stock, at the public offering price of $95.00 per
share, resulting in proceeds to Alnylam of approximately $70.7 million.
The exercise of this right allowed Genzyme to maintain its current
ownership level of Alnylam common stock of approximately 12%.
Non-GAAP Net Loss
The non-GAAP net loss for the year ended December 31, 2014 was $139.6
million, or $1.88 per share on both a basic and diluted basis as
compared to a non-GAAP net loss of $89.2 million, or $1.45 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, described below.
GAAP Net Loss
The net loss according to GAAP for the fourth quarter of 2014 was $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), as compared to a net loss of $32.4 million, or $0.51 per share
on both a basic and diluted basis (including $5.4 million, or $0.09 per
share of non-cash stock-based compensation expense), for the same period
in the previous year. For the year ended December 31, 2014, the net loss
was $360.4 million, or $4.85 per share (including $33.1 million, or
$0.45 per share of non-cash stock-based compensation expense), as
compared to a net loss of $89.2 million, or $1.45 per share (including
$20.7 million, or $0.34 per share of non-cash stock-based compensation
expense), for the same period in the previous year. The increase in net
loss for the year ended December 31, 2014 compared to the prior year
resulted primarily from a $220.8 million charge to in-process research
and development expense in connection with the purchase of the Sirna
RNAi assets from Merck, described below.
Revenues
Revenues were $24.0 million for the fourth quarter of 2014, as compared
to $10.8 million for the same period last year. Revenues for the fourth
quarter of 2014 included $8.8 million in revenues from the company’s
collaboration with Monsanto, $6.9 million of revenues related to the
company’s collaboration with The Medicines Company, $5.5 million of
revenues from the company’s alliance with Takeda Pharmaceuticals Company
Limited, and $2.8 million of revenues from research reagent licenses and
other sources. Revenues were $50.6 million for the year ended December
31, 2014, as compared to $47.2 million for the prior year. Revenues for
the year ended December 31, 2014 included $22.0 million of revenues
related to the company’s collaboration with Takeda, $15.0 million of
revenues related to the company’s collaboration with Monsanto, $10.8
million of revenues related to the company’s collaboration with The
Medicines Company, and $2.8 million of revenues from research reagent
licenses and other sources.
Research and Development Expenses
Research and development (R&D) expenses were $55.5 million in the fourth
quarter of 2014, which included $8.2 million of non-cash stock-based
compensation, as compared to $32.1 million in the fourth quarter of
2013, which included $3.3 million of non-cash stock-based compensation.
R&D expenses were $190.2 million for the year ended December 31, 2014,
which included $18.2 million of non-cash stock-based compensation, as
compared to $113.0 million for the prior year, which included $14.4
million of non-cash stock-based compensation. The increase in R&D
expenses for the quarter and year ended December 31, 2014 as compared to
the prior year periods was due primarily to additional expenses
associated with the significant advancement of certain of the company’s
clinical and pre-clinical programs. The company expects that R&D
expenses will increase significantly in 2015 as it continues to advance
and expand its pipeline across its three STArs.
In-Process Research and Development Expense
In 2014, the company incurred a $220.8 million charge to in-process
research and development expense in connection with the purchase of the
Sirna RNAi assets from Merck. In future periods, there will be no
additional charges recorded to in-process research and development
related to this purchase of the Sirna RNAi assets from Merck.
General and Administrative Expenses
General and administrative (G&A) expenses were $14.2 million in the
fourth quarter of 2014, which included $5.2 million of non-cash
stock-based compensation, as compared to $8.3 million in the fourth
quarter of 2013, which included $2.1 million of non-cash stock-based
compensation. G&A expenses were $44.5 million for the year ended
December 31, 2014, which included $14.8 million of non-cash stock-based
compensation, as compared to $27.2 million in 2013, which included $6.3
million of non-cash stock-based compensation. G&A expenses for the
quarter and year ended December 31, 2014 as compared to the prior year
periods increased due primarily to an increase in non-cash stock-based
compensation expenses. In addition, consulting and professional services
increased during the year ended December 31, 2014 as compared to the
prior year related to general business activities and certain
professional services. The company expects that G&A expenses will
increase slightly in 2015.
Benefit from (Provision for) Income Taxes
The company had a benefit from income taxes of $22.1 million for the
fourth quarter of 2014 as compared to a provision for income taxes of
$3.0 million for the fourth quarter of 2013. The company’s benefit from
income taxes was $40.2 million for the year ended December 31, 2014, as
compared to $2.7 million for the prior year. The increase during the
quarter and year ended December 31, 2014 as compared to the prior year
periods was due primarily to the corresponding income tax expense
associated with the increase in the value of our investment in Regulus,
as well as the difference between the value of stock and the cash
proceeds received from Genzyme for the issuance of our common stock. The
corresponding income tax expense has been recorded in other
comprehensive income and additional paid-in capital, respectively.
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, 2014, the fair market value of the
company’s investment in Regulus was $94.6 million as compared to $45.5
million at December 31, 2013.
2015 Financial Guidance
Alnylam expects that its cash, cash equivalents, and total marketable
securities balance will be greater than $1.2 billion at December 31,
2015.
Conference Call Information
Management will provide an update
on the company, discuss fourth quarter and 2014 results, and discuss
expectations for the future via conference call on Thursday, February
12, 2015 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 82620462. A replay of
the call will be available beginning at 7:30 p.m. ET on February 12,
2015. To access the replay, please dial 855-859-2056 (domestic) or
404-537-3406 (international), and refer to conference ID 82620462.
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. 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
Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist, GlaxoSmithKline,
Ascletis, Monsanto, The Medicines Company, and Genzyme, a Sanofi
company. 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. 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 expectations regarding its
“Alnylam 2020” guidance, Alnylam’s views with respect to the potential
for RNAi therapeutics, including patisiran, revusiran, ALN-AT3, ALN-CC5,
ALN-PCSsc, ALN-AS1, ALN-AAT, ALN-HBV, and ALN-GO1, 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-AS1 and ALN-AAT, , its expectations
regarding reporting of data from its clinical and pre-clinical studies,
including its studies for patisiran, revusiran, ALN-AT3, ALN-CC5, and
ALN-PCSsc, as well as other research programs and technologies, its
plans regarding commercialization of RNAi therapeutics, and Alnylam’s
expected cash position as of December 31, 2015, 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 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 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
INCOME (LOSS)
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(In thousands, except per share amounts)
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Three Months Ended
December 31,
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Year Ended
December 31,
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2014
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2013
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2014
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2013
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Net revenues from collaborators
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$
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24,019
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$
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10,847
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$
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50,561
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$
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47,167
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Operating expenses:
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Research and development (1)
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55,546
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32,106
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190,249
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112,957
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In-process research and development
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—
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—
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220,766
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—
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General and administrative (1)
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14,185
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8,333
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44,526
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27,152
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Total operating expenses
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69,731
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40,439
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|
|
455,541
|
|
|
|
140,109
|
Loss from operations
|
|
|
|
|
( 45,712)
|
|
|
|
(29,592)
|
|
|
|
|
(404,980)
|
|
|
|
(92,942)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
780
|
|
|
|
285
|
|
|
|
|
2,559
|
|
|
|
1,069
|
Other income (expense)
|
|
|
|
|
1,452
|
|
|
|
(29)
|
|
|
|
|
1,817
|
|
|
|
(47)
|
Total other income
|
|
|
|
|
2,232
|
|
|
|
256
|
|
|
|
|
4,376
|
|
|
|
1,022
|
Loss before income taxes
|
|
|
|
|
(43,480)
|
|
|
|
(29,336)
|
|
|
|
|
(400,604)
|
|
|
|
(91,920)
|
Benefit from (provision for) income taxes
|
|
|
|
|
22,091
|
|
|
|
(3,021)
|
|
|
|
|
40,209
|
|
|
|
2,695
|
Net loss
|
|
|
|
$
|
(21,389)
|
|
|
$
|
(32,357)
|
|
|
|
$
|
(360,395)
|
|
|
$
|
(89,225)
|
Net loss per common share - basic and diluted
|
|
|
|
$
|
(0.28)
|
|
|
$
|
(0.51)
|
|
|
|
$
|
(4.85)
|
|
|
$
|
(1.45)
|
Weighted average common shares used to compute basic and diluted net
loss per common share
|
|
|
|
|
76,957
|
|
|
|
62,909
|
|
|
|
|
74,278
|
|
|
|
61,551
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
$
|
(21,389)
|
|
|
$
|
(32,357)
|
|
|
|
$
|
(360,395)
|
|
|
$
|
(89,225)
|
Unrealized gain (loss) on marketable securities, net of tax
|
|
|
|
|
35,091
|
|
|
|
(7,451)
|
|
|
|
|
31,127
|
|
|
|
4,055
|
Reclassification adjustment for realized gain on marketable
securities included in net loss
|
|
|
|
|
(1,514)
|
|
|
|
—
|
|
|
|
|
(2,081)
|
|
|
|
—
|
Comprehensive income (loss)
|
|
|
|
$
|
12,188
|
|
|
$
|
(39,808)
|
|
|
|
$
|
(331,349)
|
|
|
$
|
(85,170)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Non-cash stock-based compensation expenses included in
operating expenses are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
$
|
8,214
|
|
|
$
|
3,277
|
|
|
|
$
|
18,233
|
|
|
$
|
14,369
|
General and administrative
|
|
|
|
|
5,224
|
|
|
|
2,129
|
|
|
|
|
14,828
|
|
|
|
6,334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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,
|
|
|
|
|
2014
|
|
|
2013
|
|
|
|
2014
|
|
|
2013
|
GAAP net loss
|
|
|
|
$
|
(21,389)
|
|
|
$
|
(32,357)
|
|
|
|
$
|
(360,395)
|
|
|
$
|
(89,225)
|
Adjustment:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
220,766
|
|
|
|
—
|
Non-GAAP net loss
|
|
|
|
$
|
(21,389)
|
|
|
$
|
(32,357)
|
|
|
|
$
|
(139,629)
|
|
|
$
|
(89,225)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per common share - basic and diluted
|
|
|
|
$
|
(0.28)
|
|
|
$
|
(0.51)
|
|
|
|
$
|
(4.85)
|
|
|
$
|
(1.45)
|
Adjustment (as detailed above)
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
2.97
|
|
|
|
—
|
Non-GAAP net loss per common share - basic and diluted
|
|
|
|
$
|
(0.28)
|
|
|
$
|
(0.51)
|
|
|
|
$
|
(1.88)
|
|
|
$
|
(1.45)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 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
excludes the in-process research and development expense of $220.8
million 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
December 31,
|
|
|
|
|
2014
|
|
|
|
2013
|
Cash, cash equivalents and total marketable securities
|
|
|
|
$ 881,929
|
|
|
|
$ 350,472
|
Billed and unbilled collaboration receivables
|
|
|
|
39,937
|
|
|
|
4,248
|
Prepaid expenses and other current assets
|
|
|
|
9,739
|
|
|
|
3,910
|
Deferred tax assets
|
|
|
|
31,667
|
|
|
|
—
|
Property and equipment, net
|
|
|
|
21,740
|
|
|
|
16,448
|
Investment in equity securities of Regulus Therapeutics Inc.
|
|
|
|
94,583
|
|
|
|
45,452
|
Total assets
|
|
|
|
$ 1,079,595
|
|
|
|
$ 420,530
|
Accounts payable and accrued expenses
|
|
|
|
$ 38,791
|
|
|
|
$ 20,056
|
Deferred tax liabilities
|
|
|
|
31,667
|
|
|
|
—
|
Total deferred revenue
|
|
|
|
66,854
|
|
|
|
126,090
|
Total deferred rent
|
|
|
|
6,016
|
|
|
|
4,037
|
Total stockholders’ equity (77.2 million and 63.7 million common
shares issued and outstanding and at December 31, 2014 and December
31, 2013, respectively)
|
|
|
|
936,267
|
|
|
|
270,347
|
Total liabilities and stockholders' equity
|
|
|
|
$ 1,079,595
|
|
|
|
$ 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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