− Achieved First Quarter 2024 Global Net
Product Revenues of $365 Million, Representing 32% Year-Over-Year
Growth Compared to Q1 2023, Including Continued Momentum from Total
TTR Delivering 29% Year-Over-Year Growth –
− Demonstrated Strong Progress with Zilebesiran
Hypertension Program with Positive Results from KARDIA-2 Phase 2
Study and Initiation of KARDIA-3 Phase 2 Study –
− Remain on Track to Report Topline Results
from HELIOS-B Phase 3 Study of Vutrisiran in Late June or Early
July –
− Reiterated 2024 Financial Guidance, Including
Combined Net Product Revenues of $1,400 Million to $1,500 Million
–
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today reported its consolidated financial
results for the first quarter ended March 31, 2024 and reviewed
recent business highlights.
“2024 is off to a strong start, with exceptional commercial
performance where we delivered $365 million in global net product
revenues, representing 32% year-over-year growth for our four
wholly owned products. We also made great progress with our
pipeline, particularly with the zilebesiran program in
hypertension, for which we reported positive results from the
KARDIA-2 Phase 2 study, and initiated the KARDIA-3 Phase 2 study,”
said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam.
“Looking ahead, we are eagerly awaiting topline results from the
HELIOS-B Phase 3 study of vutrisiran in late June or early July,
potentially expanding our leadership in ATTR amyloidosis.
Additionally, we look forward to early-stage developments with
mivelsiran (formerly ALN-APP), where we expect to start a Phase 2
study in cerebral amyloid angiopathy in the coming months. These
achievements position us well to deliver on our Alnylam P5x25 goals
of becoming a top-tier biotech company delivering sustained
innovation and exceptional financial results.”
First Quarter 2024 and Recent Significant Corporate
Highlights
Commercial Performance
Total TTR: ONPATTRO® (patisiran) & AMVUTTRA®
(vutrisiran)
- Continued growth momentum in total TTR, achieving global net
product revenues for ONPATTRO and AMVUTTRA for the first quarter of
$69 million and $195 million, respectively, representing 4% total
TTR quarterly growth compared to Q4 2023 and 29% annual growth
compared to Q1 2023.
Total Rare: GIVLAARI® (givosiran) & OXLUMO®
(lumasiran)
- Achieved global net product revenues for GIVLAARI and OXLUMO
for the first quarter of $58 million and $43 million, respectively,
representing 9% total Rare quarterly growth compared to Q4 2023 and
40% annual growth compared to Q1 2023.
R&D Highlights
Announced updates to the statistical analysis plan for the
HELIOS-B Phase 3 study of vutrisiran in patients with ATTR
amyloidosis with cardiomyopathy, including adjustments to the
primary and secondary endpoints and analysis period. Topline
results remain on track to be reported in late June or early
July.
Reported positive results from the KARDIA-2 Phase 2 study of
zilebesiran added to standard-of-care antihypertensives in
patients with inadequately controlled hypertension.
Initiated the global KARDIA-3 Phase 2 study of
zilebesiran in adult patients with high cardiovascular risk
and uncontrolled hypertension despite treatment with two to four
standard of care antihypertensive medications. Study initiation
triggered a $65 million milestone payment from Roche.
Published results from the Phase 2 KARDIA-1 study of
zilebesiran in the Journal of the American Medical
Association (JAMA).
Received clearance from the U.S. Food and Drug Administration
(FDA) to initiate the multiple-dose part (Part B) of the ongoing
Phase 1 study of mivelsiran (formerly ALN-APP) in early
onset Alzheimer’s disease. The FDA has confirmed that
multiple-dosing in the Phase 1 study may proceed at doses up to 180
mg given every six months, which covers all dose regimens planned
to be explored in Part B. A partial clinical hold remains for
higher or more frequent dosing regimens.
Presented new preclinical data for ALN-HTT02, an
investigational RNAi therapeutic targeting huntingtin (HTT) in
development for the treatment of Huntington’s disease at the CHDI
Foundation’s 19th Annual Huntington’s Disease Therapeutics
Conference.
Upcoming Events
In early and mid-2024, Alnylam intends to:
- Report topline results from the HELIOS-B Phase 3 study of
vutrisiran in late June or early July.
- Initiate a Phase 2 study of mivelsiran (formerly
ALN-APP) in patients with cerebral amyloid angiopathy.
- Initiate Part B of the Phase 1 study of ALN-KHK, in
development for the treatment of Type 2 diabetes mellitus.
- Initiate a Phase 1 study of ALN-BCAT, in development for
the treatment of hepatocellular carcinoma.
Financial Results for the Quarter Ended March 31,
2024
Three Months Ended March
31,
(In thousands, except per share
amounts)
2024
2023
Net product revenues
$
365,163
$
276,328
Net revenue from collaborations
$
118,548
$
36,462
Royalty revenue
$
10,622
$
6,500
GAAP Operating loss
$
(43,435
)
$
(149,807
)
Non-GAAP Operating gain (loss)
$
1,912
$
(109,860
)
GAAP Net loss
$
(65,935
)
$
(174,101
)
Non-GAAP Net loss
$
(20,666
)
$
(131,887
)
GAAP Net loss per common share - basic and
diluted
$
(0.52
)
$
(1.40
)
Non-GAAP Net loss per common share - basic
and diluted
$
(0.16
)
$
(1.06
)
For an explanation of our use of non-GAAP
financial measures refer to the “Use of Non-GAAP Financial
Measures” section later in this press release and for a
reconciliation of each non-GAAP financial measure to the most
comparable GAAP measures, see the table at the end of this press
release.
Net Product Revenues
Three Months Ended March
31,
Year over Year %
Growth
(In thousands, except percentages)
2024
2023
As Reported
At CER*
ONPATTRO net product revenues
$
69,217
$
102,493
(32)%
(33)%
AMVUTTRA net product revenues
195,241
101,768
92%
93%
Total TTR net product revenues
264,458
204,261
29%
30%
GIVLAARI net product revenues
58,056
47,906
21%
21%
OXLUMO net product revenues
42,649
24,161
77%
75%
Total Rare net product revenues
100,705
72,067
40%
39%
Total net product revenues
$
365,163
$
276,328
32%
32%
* CER = Constant Exchange Rate,
representing growth calculated as if the exchange rates had
remained unchanged from those used in the first quarter 2023. CER
is a Non-GAAP measure.
- Total net product revenues increased 32% at both actual
currency and CER during the three months ended March 31, 2024, as
compared to the same period in 2023, due to strong growth from
AMVUTTRA driven by increased patient demand, as well as increased
patients on our GIVLAARI and OXLUMO therapies.
Net Revenues from Collaborations
- Net revenues from collaborations increased 225% during the
three months ended March 31, 2024, as compared to the same period
in 2023, primarily due to revenue recognized under our
collaboration and license agreement with Roche, including $65
million of milestone revenue associated with dosing the first
patient in the zilebesiran KARDIA-3 clinical trial, and an increase
in revenue recognized under our collaboration agreement with
Regeneron as a result of an increase in activities under our
research services arrangement and licensed programs.
Operating Expenses
Three Months Ended March
31,
(In thousands, except percentages)
2024
2023
Cost of goods sold
$
54,613
$
41,432
Cost of goods sold as a percentage of net
product revenues
15.0
%
15.0
%
Cost of collaborations and royalties
$
11,363
$
13,437
GAAP research and development expenses
$
260,995
$
230,569
Non-GAAP research and development
expenses
$
241,780
$
214,337
GAAP selling, general and administrative
expenses
$
210,797
$
183,659
Non-GAAP selling, general and
administrative expenses
$
184,665
$
159,944
Cost of Goods Sold
- Cost of goods sold as a percentage of net product revenues was
consistent during the three months ended March 31, 2024, as
compared to the same period in 2023, primarily due to increased
royalties related to higher AMVUTTRA sales volume, partially offset
by one-time favorability attributed to reduced ONPATTRO
manufacturing cancellation fees.
Research & Development (R&D) Expenses
- GAAP and non-GAAP R&D expenses increased during the three
months ended March 31, 2024, as compared to the same period in
2023, primarily due to increased development expenses associated
with zilebesiran in the KARDIA-2 and KARDIA-3 clinical studies,
increased expenses associated with our HELIOS-B study leading up to
the topline data readout in late June or early July 2024, increased
costs associated with our preclinical activities, specifically our
CNS programs, and increased headcount and infrastructure expenses
to support our R&D pipeline.
Selling, General & Administrative (SG&A) Expenses
- GAAP and non-GAAP SG&A expenses increased during the three
months ended March 31, 2024, as compared to the same period in
2023, primarily due to increased marketing investment associated
with promotion of our TTR therapies and increased headcount and
other investments supporting our strategic growth.
Other Financial Highlights
- Cash, cash equivalents and marketable securities were $2.37
billion as of March 31, 2024 compared to $2.44 billion as of
December 31, 2023 with the decrease primarily due our operating
loss in the first quarter 2024.
A reconciliation of our GAAP to non-GAAP results for the quarter
is included in the tables at the end of this press release.
2024 Financial Guidance
Full year 2024 financial guidance is reiterated as follows:
Combined net product revenues for
ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO1
$1,400 million - $1,500
million
Net Product Revenue Growth vs. 2023 at
reported FX rates1
13% to 21%
Net Product Revenue Growth vs. 2023 at
CER*
13% to 21%
Net revenues from collaborations and
royalties
$325 million - $425 million
GAAP R&D and SG&A expenses
$1,900 million - $2,050
million
Non-GAAP R&D and SG&A
expenses2
$1,675 million - $1,775
million
1 Uses January 31, 2024 FX rates
including: 1 EUR = 1.08 USD and 1 USD = 147 JPY
2 Primarily excludes $225 - $275 million
of stock-based compensation expense from estimated GAAP R&D and
SG&A expenses
*CER = Constant Exchange Rate,
representing growth calculated as if the exchange rates had
remained unchanged from those used in the twelve months ended
December 31, 2023. CER is a Non-GAAP measure.
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures,
including expenses adjusted to exclude certain non-cash expenses
and non-recurring gains outside the ordinary course of the
Company’s business. These measures are not in accordance with, or
an alternative to, GAAP, and may be different from non-GAAP
financial measures used by other companies.
The items included in GAAP presentations but excluded for
purposes of determining non-GAAP financial measures for the periods
presented in this press release are stock-based compensation
expenses and realized and unrealized losses on marketable equity
securities. The Company has excluded the impact of stock-based
compensation expense, which may fluctuate from period to period
based on factors including the variability associated with
performance-based grants for stock options and restricted stock
units and changes in the Company’s stock price, which impacts the
fair value of these awards. The Company has excluded the impact of
the realized and unrealized losses on marketable equity securities
because the Company does not believe these adjustments accurately
reflect the performance of the Company’s ongoing operations for the
period in which such gains or losses are reported, as their sole
purpose is to adjust amounts on the balance sheet.
Percentage changes in revenue growth at CER are presented
excluding the impact of changes in foreign currency exchange rates
for investors to understand the underlying business performance.
The current period’s foreign currency revenue values are converted
into U.S. dollars using the average exchange rates from the prior
period.
The Company believes the presentation of non-GAAP financial
measures provides useful information to management and investors
regarding the Company’s financial condition and results of
operations. When GAAP financial measures are viewed in conjunction
with non-GAAP financial measures, investors are provided with a
more meaningful understanding of the Company’s ongoing operating
performance and are better able to compare the Company’s
performance between periods. In addition, these non-GAAP financial
measures are among those indicators the Company uses as a basis for
evaluating performance, allocating resources and planning and
forecasting future periods. Non-GAAP financial measures are not
intended to be considered in isolation or as a substitute for GAAP
financial measures. A reconciliation between GAAP and non-GAAP
measures is provided later in this press release.
Conference Call Information
Management will provide an update on the Company and discuss
first quarter 2024 results as well as expectations for the future
via conference call on Thursday, May 2, 2024 at 8:30 am ET. To
access the call, please register online at
https://register.vevent.com/register/BI0abdd195e81a43d9ac0c44fe9d789f86.
Participants are requested to register at least 15 minutes before
the start of the call. A replay of the call will be available two
hours after the call and archived on the same web page for six
months.
A live audio webcast of the call will be available on the
Investors section of the Company’s website at
www.alnylam.com/events. An archived webcast will be available on
the Alnylam website approximately two hours after the event.
About ONPATTRO® (patisiran)
ONPATTRO is an RNAi therapeutic that is approved in the United
States and Canada for the treatment of adults with hATTR
amyloidosis with polyneuropathy. ONPATTRO is also approved in the
European Union, Switzerland and Brazil for the treatment of hATTR
amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and
in Japan for the treatment of hATTR amyloidosis with
polyneuropathy. ONPATTRO is an intravenously administered RNAi
therapeutic targeting transthyretin (TTR). It is designed to target
and silence TTR messenger RNA, thereby reducing the production of
TTR protein before it is made. Reducing the pathogenic protein
leads to a reduction in amyloid deposits in tissues. For more
information about ONPATTRO, including full Prescribing Information,
visit ONPATTRO.com.
About AMVUTTRA® (vutrisiran)
AMVUTTRA® (vutrisiran) is an RNAi therapeutic approved in the
United States for the treatment of adults with hATTR amyloidosis
with polyneuropathy. It is a double-stranded small interfering RNA
(siRNA) that targets mutant and wild-type transthyretin (TTR)
messenger RNA (mRNA). Using Alnylam’s Enhanced Stabilization
Chemistry (ESC)-GalNAc-conjugate delivery platform, AMVUTTRA is
designed for increased potency and high metabolic stability to
allow for subcutaneous injection once every three months
(quarterly). Results from the pivotal HELIOS-A Phase 3 study
demonstrate AMVUTTRA rapidly reduces serum TTR levels, has the
potential to reverse neuropathy impairment relative to baseline and
improves other key measures of disease burden relative to external
placebo in patients with the polyneuropathy of hATTR amyloidosis.
For more information about AMVUTTRA, including the full U.S.
Prescribing Information, visit AMVUTTRA.com.
About GIVLAARI® (givosiran)
GIVLAARI (givosiran) is an RNAi therapeutic targeting
aminolevulinic acid synthase 1 (ALAS1) approved in the United
States and Brazil for the treatment of adults with acute hepatic
porphyria (AHP). GIVLAARI is also approved in the European Union
for the treatment of AHP in adults and adolescents aged 12 years
and older. In the pivotal study, givosiran was shown to
significantly reduce the rate of porphyria attacks that required
hospitalizations, urgent healthcare visits or intravenous hemin
administration at home compared to placebo. GIVLAARI is Alnylam’s
first commercially available therapeutic based on its Enhanced
Stabilization Chemistry ESC-GalNAc conjugate technology to increase
potency and durability. GIVLAARI is administered via subcutaneous
injection once monthly at a dose based on actual body weight and
should be administered by a healthcare professional. GIVLAARI works
by specifically reducing elevated levels of ALAS1 messenger RNA
(mRNA), leading to reduction of toxins associated with attacks and
other disease manifestations of AHP. For more information about
GIVLAARI, including the full U.S. Prescribing Information, visit
GIVLAARI.com.
About OXLUMO® (lumasiran)
OXLUMO (lumasiran) is an RNAi therapeutic targeting hydroxyacid
oxidase 1 (HAO1). HAO1 encodes glycolate oxidase (GO). Thus, by
silencing HAO1 and depleting the GO enzyme, OXLUMO inhibits
production of oxalate – the metabolite that directly contributes to
the pathophysiology of PH1. OXLUMO utilizes Alnylam’s Enhanced
Stabilization Chemistry (ESC)-GalNAc-conjugate technology, which
enables subcutaneous dosing with increased potency and durability
and a wide therapeutic index. OXLUMO has received regulatory
approvals from the U.S. Food and Drug Administration (FDA) for the
treatment of primary hyperoxaluria type 1 (PH1) to lower urinary
and plasma oxalate levels in pediatric and adult patients and from
the European Medicines Agency (EMA) for the treatment of PH1 in all
age groups. In the pivotal ILLUMINATE-A study, OXLUMO was shown to
significantly reduce levels of urinary oxalate relative to placebo,
with the majority of patients reaching normal or near-normal
levels. In the ILLUMINATE-B pediatric Phase 3 study, OXLUMO
demonstrated an efficacy and safety profile consistent to that
observed in ILLUMINATE-A. In the ILLUMINATE-C study, OXLUMO
resulted in substantial reductions in plasma oxalate in patients
with advanced PH1. Across all three studies, injection site
reactions (ISRs) were the most common drug-related adverse
reaction. OXLUMO is administered via subcutaneous injection once
monthly for three months, then once quarterly beginning one month
after the last loading dose at a dose based on actual body weight.
For patients who weigh less than 10 kg, ongoing dosing remains
monthly. OXLUMO should be administered by a healthcare
professional. For more information about OXLUMO, including the full
U.S. Prescribing Information, visit OXLUMO.com.
About LNP Technology
Alnylam has licenses to Arbutus Biopharma lipid nanoparticle
(LNP) intellectual property for use in RNAi therapeutic products
using LNP technology.
About RNAi
RNAi (RNA interference) is a natural cellular process of gene
silencing that represents one of the most promising and rapidly
advancing frontiers in biology and drug development today. Its
discovery has been heralded as “a major scientific breakthrough
that happens once every decade or so,” and was recognized with the
award of the 2006 Nobel Prize for Physiology or Medicine. By
harnessing the natural biological process of RNAi occurring in our
cells, a new class of medicines known as RNAi therapeutics is now a
reality. Small interfering RNA (siRNA), the molecules that mediate
RNAi and comprise Alnylam’s RNAi therapeutic platform, function
upstream of today’s medicines by potently silencing messenger RNA
(mRNA) – the genetic precursors – that encode for disease-causing
or disease pathway proteins, thus preventing them from being made.
This is a revolutionary approach with the potential to transform
the care of patients with genetic and other diseases.
About Alnylam Pharmaceuticals
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation
of RNA interference (RNAi) into a whole new class of innovative
medicines with the potential to transform the lives of people
afflicted with rare and prevalent diseases with unmet need. Based
on Nobel Prize-winning science, RNAi therapeutics represent a
powerful, clinically validated approach yielding transformative
medicines. Since its founding in 2002, Alnylam has led the RNAi
Revolution and continues to deliver on a bold vision to turn
scientific possibility into reality. Alnylam’s commercial RNAi
therapeutic products are ONPATTRO® (patisiran), AMVUTTRA®
(vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and
Leqvio® (inclisiran), which is being developed and commercialized
by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of
investigational medicines, including multiple product candidates
that are in late-stage development. Alnylam is executing on its
“Alnylam P5x25” strategy to deliver transformative medicines in
both rare and common diseases benefiting patients around the world
through sustainable innovation and exceptional financial
performance, resulting in a leading biotech profile. Alnylam is
headquartered in Cambridge, MA. For more information about our
people, science and pipeline, please visit www.alnylam.com and
engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn,
Facebook, or Instagram.
Alnylam Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. All statements
other than historical statements of fact regarding Alnylam’s
expectations, beliefs, goals, plans or prospects including, without
limitation, statements regarding Alnylam’s aspiration to become a
top-tier biotech company, the potential for Alnylam to identify new
potential drug development candidates and advance its research and
development programs, Alnylam’s ability to obtain approval for new
commercial products or additional indications for its existing
commercial products, and Alnylam’s projected commercial and
financial performance, including the expected range of net product
revenues and net revenues from collaborations and royalties for
2024, the expected range of aggregate annual GAAP and non-GAAP
R&D and SG&A expenses for 2024, the expected timing of
topline data from the HELIOS-B Phase 3 clinical study, and the
planned achievement of its “Alnylam P5x25” strategy, should be
considered forward-looking statements. Actual results and future
plans may differ materially from those indicated by these
forward-looking statements as a result of various important risks,
uncertainties and other factors, including, without limitation,
risks and uncertainties relating to: Alnylam’s ability to
successfully execute on its “Alnylam P5x25” strategy; Alnylam’s
ability to discover and develop novel drug candidates and delivery
approaches and successfully demonstrate the efficacy and safety of
its product candidates; the pre-clinical and clinical results for
Alnylam’s product candidates, including vutrisiran, zilebesiran,
and ALN-APP; actions or advice of regulatory agencies and Alnylam’s
ability to obtain and maintain regulatory approval for its product
candidates, including vutrisiran, as well as favorable pricing and
reimbursement; successfully launching, marketing and selling
Alnylam’s approved products globally; delays, interruptions or
failures in the manufacture and supply of Alnylam’s product
candidates or its marketed products; obtaining, maintaining and
protecting intellectual property; Alnylam’s ability to successfully
expand the approved indications for AMVUTTRA in the future;
Alnylam’s ability to manage its growth and operating expenses
through disciplined investment in operations and its ability to
achieve a self-sustainable financial profile in the future without
the need for future equity financing; the direct or indirect impact
of the COVID-19 global pandemic or any future pandemic on Alnylam’s
business, results of operations and financial condition; Alnylam’s
ability to maintain strategic business collaborations; Alnylam’s
dependence on third parties for the development and
commercialization of certain products, including Roche, Novartis,
Sanofi, Regeneron and Vir; the outcome of litigation; the risk of
future government investigations; and unexpected expenditures; as
well as those risks and uncertainties more fully discussed in the
“Risk Factors” filed with Alnylam’s 2023 Annual Report on Form 10-K
filed with the Securities and Exchange Commission (SEC), as may be
updated from time to time in Alnylam’s subsequent Quarterly Reports
on Form 10-Q, and in other filings that Alnylam makes with the SEC.
In addition, any forward-looking statements represent Alnylam’s
views only as of today and should not be relied upon as
representing its views as of any subsequent date. Alnylam
explicitly disclaims any obligation, except to the extent required
by law, to update any forward-looking statements.
This release discusses investigational RNAi therapeutics and
uses of previously approved RNAi therapeutics in development and is
not intended to convey conclusions about efficacy or safety as to
those investigational therapeutics or uses. There is no guarantee
that any investigational therapeutics or expanded uses of
commercial products will successfully complete clinical development
or gain health authority approval.
ALNYLAM PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In
thousands, except per share amounts)
March 31, 2024
December 31, 2023
ASSETS
(Unaudited)
Current assets:
Cash and cash equivalents
$
681,879
$
812,688
Marketable debt securities
1,678,147
1,615,516
Marketable equity securities
11,256
11,178
Accounts receivable, net
321,377
327,787
Inventory
93,988
89,146
Prepaid expenses and other current
assets
201,960
126,382
Total current assets
2,988,607
2,982,697
Property, plant and equipment, net
523,460
526,057
Operating lease right-of-use assets
195,468
199,732
Restricted investments
49,390
49,391
Other assets
67,461
72,003
Total assets
$
3,824,386
$
3,829,880
LIABILITIES AND STOCKHOLDERS’
DEFICIT
Current liabilities:
Accounts payable
$
78,148
$
55,519
Accrued expenses
698,865
713,013
Operating lease liability
41,672
41,510
Deferred revenue
76,850
102,753
Liability related to the sale of future
royalties
46,174
54,991
Total current liabilities
941,709
967,786
Operating lease liability, net of current
portion
237,829
243,101
Deferred revenue, net of current
portion
185,506
188,175
Convertible debt
1,021,732
1,020,776
Liability related to the sale of future
royalties, net of current portion
1,336,892
1,322,248
Other liabilities
319,990
308,438
Total liabilities
4,043,658
4,050,524
Commitments and contingencies (Note
13)
Stockholders’ deficit:
Preferred stock, $0.01 par value per
share, 5,000 shares authorized and no shares issued and outstanding
as of March 31, 2024 and December 31, 2023
—
—
Common stock, $0.01 par value per share,
250,000 shares authorized; 126,463 shares issued and outstanding as
of March 31, 2024; 125,794 shares issued and outstanding as of
December 31, 2023
1,265
1,259
Additional paid-in capital
6,881,977
6,811,063
Accumulated other comprehensive loss
(26,988
)
(23,375
)
Accumulated deficit
(7,075,526
)
(7,009,591
)
Total stockholders’ deficit
(219,272
)
(220,644
)
Total liabilities and stockholders’
deficit
$
3,824,386
$
3,829,880
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, 2023.
ALNYLAM PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31, 2024
March 31, 2023
Statements of Operations
Revenues:
Net product revenues
$
365,163
$
276,328
Net revenues from collaborations
118,548
36,462
Royalty revenue
10,622
6,500
Total revenues
494,333
319,290
Operating costs and expenses:
Cost of goods sold
54,613
41,432
Cost of collaborations and royalties
11,363
13,437
Research and development
260,995
230,569
Selling, general and administrative
210,797
183,659
Total operating costs and expenses
537,768
469,097
Loss from operations
(43,435
)
(149,807
)
Other (expense) income:
Interest expense
(35,253
)
(28,955
)
Interest income
29,645
18,655
Other expense, net
(14,544
)
(12,255
)
Total other expense, net
(20,152
)
(22,555
)
Loss before income taxes
(63,587
)
(172,362
)
Provision for income taxes
(2,348
)
(1,739
)
Net loss
$
(65,935
)
$
(174,101
)
Net loss per common share - basic and
diluted
$
(0.52
)
$
(1.40
)
Weighted-average common shares used to
compute basic and diluted net loss per common share
126,138
124,111
ALNYLAM PHARMACEUTICALS,
INC. RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP
MEASURES (In thousands, except per share amounts)
(Unaudited)
Three Months Ended
March 31, 2024
March 31, 2023
Reconciliation of GAAP to Non-GAAP
Research and development:
GAAP Research and development
$
260,995
$
230,569
Less: Stock-based compensation
expenses
(19,215
)
(16,232
)
Non-GAAP Research and development
$
241,780
$
214,337
Reconciliation of GAAP to Non-GAAP
Selling, general and administrative:
GAAP Selling, general and
administrative
$
210,797
$
183,659
Less: Stock-based compensation
expenses
(26,132
)
(23,715
)
Non-GAAP Selling, general and
administrative
$
184,665
$
159,944
Reconciliation of GAAP to Non-GAAP
Operating gain (loss):
GAAP Operating loss
$
(43,435
)
$
(149,807
)
Add: Stock-based compensation expenses
45,347
39,947
Non-GAAP Operating gain (loss)
$
1,912
$
(109,860
)
Reconciliation of GAAP to Non-GAAP
Other expense, net:
GAAP Other expense, net
$
(20,152
)
$
(22,555
)
(Less) Add: Realized and unrealized (gain)
loss on marketable equity securities
(78
)
2,267
Non-GAAP Other expense, net
$
(20,230
)
$
(20,288
)
Reconciliation of GAAP to Non-GAAP Net
loss:
GAAP Net loss
$
(65,935
)
$
(174,101
)
Add: Stock-based compensation expenses
45,347
39,947
(Less) Add: Realized and unrealized (gain)
loss on marketable equity securities
(78
)
2,267
Non-GAAP Net loss
$
(20,666
)
$
(131,887
)
Reconciliation of GAAP to Non-GAAP Net
loss per common share- basic and diluted:
GAAP Net loss per common share - basic and
diluted
$
(0.52
)
$
(1.40
)
Add: Stock-based compensation expenses
0.36
0.32
(Less) Add: Realized and unrealized (gain)
loss on marketable equity securities
—
0.02
Non-GAAP Net loss per common share - basic
and diluted
$
(0.16
)
$
(1.06
)
Please note that the figures presented above
may not sum exactly due to rounding
ALNYLAM PHARMACEUTICALS,
INC. RECONCILIATION OF GAAP TO NON-GAAP PRODUCT
REVENUE GROWTH AT CONSTANT CURRENCY (Unaudited)
Three Months Ended March 31,
2024
Total TTR net product revenue growth, as
reported
29%
Add: Impact of foreign currency
translation
1
Total TTR net product revenue growth at
constant currency
30%
GIVLAARI net product revenue growth, as
reported
21%
Add: Impact of foreign currency
translation
—
GIVLAARI net product revenue growth at
constant currency
21%
OXLUMO net product revenue growth, as
reported
77%
Add: Impact of foreign currency
translation
(2)
OXLUMO net product revenue growth at
constant currency
75%
Total net product revenue growth, as
reported
32%
Add: Impact of foreign currency
translation
—
Total net product revenue growth at
constant currency
32%
Total revenue growth, as reported
55%
Add: Impact of foreign currency
translation
—
Total revenue growth at constant
currency
55%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240502396157/en/
Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom
(Investors and Media) 617-682-4340 Josh Brodsky (Investors)
617-551-8276
Alnylam Pharmaceuticals (NASDAQ:ALNY)
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