Jul 28, 2022 Press Release for Alnylam
Alnylam Pharmaceuticals Reports Second Quarter 2022 Financial Results and Highlights Recent Period Activity
Jul 28, 2022
− Achieved Second Quarter 2022 Global Net Product Revenues of
− Received FDA Approval of AMVUTTRA™ (vutrisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults –
− Expects to Report Topline Results from APOLLO-B Phase 3 Trial of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy Within the Next Three Weeks –
– Reiterated 2022 Financial Guidance, Including Combined Net Product Revenues of
“We’re pleased with our second quarter results which delivered strong growth in both patient demand and product revenues. A notable achievement in the quarter was the recent approval of AMVUTTRA, which becomes our fifth RNAi therapeutic approved in under four years, and marks our continued progress in building a multi-product TTR franchise. We’re excited to have initiated the
Second Quarter 2022 and Recent Significant Corporate Highlights
Commercial Performance
TTR Franchise: ONPATTRO® (patisiran) & AMVUTTRA™ (vutrisiran)
-
Achieved global net product revenues for ONPATTRO for the second quarter of 2022 of
$153 million , representing a 12% increase compared to Q1 2022. -
Attained over 2,400 hATTR amyloidosis patients with polyneuropathy worldwide on commercial ONPATTRO treatment as of
June 30, 2022 , up from over 2,200 commercial patients as ofMarch 31, 2022 , representing 9% quarterly growth. -
Received 133 Start Forms in the
U.S. for AMVUTTRA from launch throughJuly 22, 2022 with 34% representing patients new toAlnylam and 66% representing patients switching from ONPATTRO.
GIVLAARI® (givosiran)
-
Achieved global net product revenues for the second quarter of 2022 of
$45 million , representing a 28% increase compared to Q1 2022. -
Attained over 420 patients worldwide on commercial GIVLAARI treatment as of
June 30, 2022 , up from over 400 commercial patients as ofMarch 31, 2022 , representing 5% quarterly growth.
OXLUMO® (lumasiran)
-
Achieved global net product revenues for the second quarter of 2022 of
$15 million , representing a 2% increase compared to Q1 2022. -
Attained over 200 patients worldwide on commercial OXLUMO treatment as of
June 30, 2022 , up from over 160 commercial patients as ofMarch 31, 2022 , representing 25% quarterly growth.
Leqvio® (inclisiran)
-
Launch in the
U.S. and other markets is ongoing, with focus on patient onboarding, removing access hurdles and enhancing medical education.
R&D Highlights
Vutrisiran (the non-proprietary name for AMVUTTRA), a subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis and Stargardt Disease
- Received FDA approval of AMVUTTRA for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
-
Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) recommending approval of vutrisiran for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy. - Reported new 18-month results from exploratory cardiac endpoints from the HELIOS-A Phase 3 study in hATTR amyloidosis patients with polyneuropathy.
Lumasiran (the non-proprietary name for OXLUMO), for the treatment of primary hyperoxaluria type 1 (PH1), and in development for the treatment of recurrent kidney stone disease
- Presented new results from the ILLUMINATE-A Phase 3 study in patients with PH1.
- Presented new results from the 12-month analysis of the ILLUMINATE-B Phase 3 open-label pediatric study in patients less than six years of age with PH1.
- Presented new results from the ILLUMINATE-C Phase 3 study in patients with advanced PH1.
Cemdisiran, in development for the treatment of complement-mediated diseases, in collaboration with Regeneron.
- Reported positive topline results from the Phase 2 study in patients with immunoglobulin A nephropathy (IgAN).
-
Alnylam is working with Regeneron to finalize plans for the Phase 3 clinical development of cemdisiran in IgAN, with the potential to initiate a program by late 2022.
Fitusiran, in development for the treatment of hemophilia A or B with and without inhibitors, in collaboration with Sanofi.
-
Sanofi presented positive data from the Phase 3 ATLAS-PPX study evaluating the efficacy and safety of once-monthly fitusiran (80 mg) in adults and adolescents with severe hemophilia A or B who were previously treated with prior factor or bypassing agent (BPA) prophylaxis.
- The study met the primary endpoint and demonstrated fitusiran prophylaxis significantly reduced bleeding episodes compared to prior factor or BPA prophylaxis.
Early- and mid-stage investigational RNAi therapeutic pipeline programs and RNAi platform
- Published preclinical results in Nature Biotechnology based on novel conjugate technology facilitating delivery of siRNA to the CNS and other extrahepatic tissues.
- Vir Biotechnology presented new results from its ongoing Phase 2 clinical trial of ALN-HBV02 (VIR-2218), as well as preclinical data evaluating ALN-HBV02 in combination with VIR-3434, in patients with chronic hepatitis B virus infection.
- Initiated a Phase 1 study of ALN-XDH in patients with gout.
-
Published research findings in
Nature Communications identifying mutations in the INHBE gene associated with protection against abdominal obesity and metabolic syndrome.
Upcoming Events
In addition, the Company announces today that it plans to present results from the Phase 2 study of cemdisiran in patients with IgAN at the 18th European Meeting on Complement in Human Disease (EMCHD) being held
In addition, in mid- and late-2022,
-
Launch vutrisiran in the EU, assuming a favorable adoption of the CHMP opinion by the
European Commission , for the treatment of hATTR amyloidosis patients with polyneuropathy. - Report topline results from Part B of the Phase 1 study of ALN-HSD in patients with NASH.
- Report results on a biannual dose regimen for vutrisiran.
- Initiate a Phase 3 study of vutrisiran in patients with Stargardt Disease.
- File an Investigational New Drug (IND) application and initiate a Phase 1 study for ALN-TTRsc04 in healthy volunteers.
- Complete enrollment in the Phase 2 study of lumasiran in patients with recurrent renal stones.
- Complete enrollment in the KARDIA-2 Phase 2 study of zilebesiran (at or around year-end).
- Vir Biotechnology plans to report additional results from its Phase 2 study of ALN-HBV02 in combination with VIR-3434 in patients with chronic HBV infection in the second half of 2022.
- Report preliminary results from the Phase 1 study of ALN-APP in patients with early-onset Alzheimer's disease.
- Report preliminary results from the Phase 1 study of ALN-XDH in patients with gout.
Financial Results for the Quarter Ended |
||||||||
Financial Highlights |
||||||||
|
Three Months Ended
|
|||||||
(in thousands, except per share amounts) |
2022 |
|
2021 |
|||||
Net product revenues |
$ |
213,515 |
|
|
$ |
160,811 |
|
|
Net revenue from collaborations |
$ |
9,025 |
|
|
$ |
59,395 |
|
|
Royalty revenue |
$ |
2,278 |
|
|
$ |
347 |
|
|
|
|
|
|
|||||
GAAP Operating loss |
$ |
(191,686 |
) |
|
$ |
(146,160 |
) |
|
Non-GAAP Operating loss |
$ |
(161,215 |
) |
|
$ |
(114,082 |
) |
|
|
|
|
|
|||||
GAAP Other expense, net |
$ |
(82,987 |
) |
|
$ |
(42,171 |
) |
|
Non-GAAP Other expense, net |
$ |
(81,890 |
) |
|
$ |
(37,737 |
) |
|
|
|
|
|
|||||
GAAP Net loss |
$ |
(277,402 |
) |
|
$ |
(189,559 |
) |
|
Non-GAAP Net loss |
$ |
(245,834 |
) |
|
$ |
(153,047 |
) |
|
|
|
|
|
|||||
GAAP Net loss per common share – basic and diluted |
$ |
(2.29 |
) |
|
$ |
(1.61 |
) |
|
Non-GAAP Net loss per common share – basic and diluted |
$ |
(2.03 |
) |
|
$ |
(1.30 |
) |
Net Product Revenues | ||||||||||||
|
Three Months Ended
|
|
Year over Year %
|
|||||||||
(in thousands, except percentages) |
2022 |
|
2021 |
|
As Reported |
|
At CER* |
|||||
ONPATTRO net product revenues |
$ |
153,428 |
|
$ |
113,839 |
|
35 |
% |
|
42 |
% |
|
GIVLAARI net product revenues |
|
45,150 |
|
|
30,630 |
|
47 |
% |
|
53 |
% |
|
OXLUMO net product revenues |
|
14,937 |
|
|
16,342 |
|
(9 |
)% |
|
(4 |
)% |
|
Total |
$ |
213,515 |
|
$ |
160,811 |
|
33 |
% |
|
40 |
% |
* CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the second quarter 2021. CER is a Non-GAAP measure.
- Net product revenues increased 33% at actual currency during the second quarter of 2022, as compared to the prior year, and 40% at CER. The increase is primarily due to increased patients on ONPATTRO and GIVLAARI.
Net Revenues from Collaborations
- Net revenues from collaborations decreased 85% during the second quarter of 2022, as compared to the prior year, primarily due to a decrease in revenue from our collaboration with Regeneron resulting from the timing of reimbursable activities.
Second Quarter 2022 Expenses |
||||||
|
Three Months Ended
|
|||||
(in thousands) |
2022 |
|
2021 |
|||
GAAP research and development expenses |
$ |
205,712 |
|
$ |
182,635 |
|
Non-GAAP research and development expenses |
$ |
195,074 |
|
$ |
169,549 |
|
|
|
|
|
|||
GAAP selling, general and administrative expenses |
$ |
169,984 |
|
$ |
145,323 |
|
Non-GAAP selling, general and administrative expenses |
$ |
150,151 |
|
$ |
126,331 |
Research & Development (R&D) Expenses
- GAAP and Non-GAAP R&D expenses increased during the second quarter of 2022, as compared to the prior year, primarily due to increased early development and study activities, increased employee headcount and other expenses to support our development activities.
Selling, General & Administrative (SG&A) Expenses
- GAAP and Non-GAAP SG&A expenses increased during the second quarter of 2022, as compared to the prior year, primarily due to increased employee headcount and other expenses to support our commercial portfolio.
Other Financial Highlights
-
GAAP other expense, net, increased during the second quarter of 2022, as compared to the prior year, primarily due to an approximate
$32 million increase in the fair value of our development derivative liability and an increase in interest expenses of approximately$9 million related to additional draws on our term loan facility. -
Cash, cash equivalents and marketable securities were
$2.11 billion as ofJune 30, 2022 , compared to$2.44 billion as ofDecember 31, 2021 , with the decrease primarily due to our operating loss in the second quarter of 2022.
A reconciliation of our GAAP to non-GAAP results for the current quarter is included in the tables of this press release.
2022 Financial Guidance1
Full year 2022 financial guidance is reiterated and consists of the following:
Combined net product revenues for ONPATTRO, GIVLAARI, OXLUMO and AMVUTTRA |
|
Net revenues from collaborations and royalties |
|
GAAP R&D and SG&A expenses |
|
Non-GAAP R&D and SG&A expenses2 |
|
1 Guidance utilizes |
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 and revenue growth excluding the impact of changes in foreign exchange rates. 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 (gains) 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 (gains) 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
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 second quarter 2022 results as well as expectations for the future via conference call on
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
About ONPATTRO® (patisiran)
ONPATTRO is an RNAi therapeutic that was approved in
About GIVLAARI® (givosiran)
GIVLAARI is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) approved in
About OXLUMO® (lumasiran)
OXLUMO is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients. HAO1 encodes glycolate oxidase (GO), an enzyme upstream of the disease-causing defect in PH1. OXLUMO works by degrading HAO1 messenger RNA and reducing the synthesis of GO, which inhibits hepatic production of oxalate – the toxic metabolite responsible for the clinical manifestations of PH1. 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. Injection site reactions (ISRs) were the most common drug-related adverse reaction. In the ILLUMINATE-B pediatric Phase 3 study, OXLUMO demonstrated an efficacy and safety profile consistent to that observed in ILLUMINATE-A. OXLUMO utilizes Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc conjugate technology designed to increase potency and durability. OXLUMO is administered via subcutaneous injection once monthly for three months, then once quarterly thereafter 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
About AMVUTTRA™ (vutrisiran)
AMVUTTRA™ (vutrisiran) is an RNAi therapeutic approved in
About 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
About
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam’s expectations, plans, aspirations and goals, including, without limitation, our aspiration to become a leading biotech company and the planned achievement of our “Alnylam P5x25” strategy, the launch of AMVUTTRA in the
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) |
||||||||||||||||
|
Three Months Ended |
|
Six Months Ended |
|||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Statements of Operations |
|
|
|
|
|
|
|
|||||||||
Revenues: |
|
|
|
|
|
|
|
|||||||||
Net product revenues |
$ |
213,515 |
|
|
$ |
160,811 |
|
|
$ |
400,387 |
|
|
$ |
296,580 |
|
|
Net revenues from collaborations |
|
9,025 |
|
|
|
59,395 |
|
|
|
34,970 |
|
|
|
101,192 |
|
|
Royalty revenue |
|
2,278 |
|
|
|
347 |
|
|
|
2,720 |
|
|
|
347 |
|
|
Total revenues |
|
224,818 |
|
|
|
220,553 |
|
|
|
438,077 |
|
|
|
398,119 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
|||||||||
Cost of goods sold |
|
34,038 |
|
|
|
30,256 |
|
|
|
57,495 |
|
|
|
53,279 |
|
|
Cost of collaborations and royalties |
|
6,770 |
|
|
|
8,499 |
|
|
|
18,940 |
|
|
|
16,538 |
|
|
Research and development |
|
205,712 |
|
|
|
182,635 |
|
|
|
375,605 |
|
|
|
368,534 |
|
|
Selling, general and administrative |
|
169,984 |
|
|
|
145,323 |
|
|
|
324,455 |
|
|
|
292,182 |
|
|
Total operating costs and expenses |
|
416,504 |
|
|
|
366,713 |
|
|
|
776,495 |
|
|
|
730,533 |
|
|
Loss from operations |
|
(191,686 |
) |
|
|
(146,160 |
) |
|
|
(338,418 |
) |
|
|
(332,414 |
) |
|
Other (expense) income: |
|
|
|
|
|
|
|
|||||||||
Interest expense |
|
(42,609 |
) |
|
|
(33,416 |
) |
|
|
(84,971 |
) |
|
|
(65,931 |
) |
|
Other (expense) income, net |
|
(40,378 |
) |
|
|
(8,755 |
) |
|
|
(90,640 |
) |
|
|
10,739 |
|
|
Total other expense, net |
|
(82,987 |
) |
|
|
(42,171 |
) |
|
|
(175,611 |
) |
|
|
(55,192 |
) |
|
Loss before income taxes |
|
(274,673 |
) |
|
|
(188,331 |
) |
|
|
(514,029 |
) |
|
|
(387,606 |
) |
|
Provision for income taxes |
|
(2,729 |
) |
|
|
(1,228 |
) |
|
|
(3,714 |
) |
|
|
(2,244 |
) |
|
Net loss |
$ |
(277,402 |
) |
|
$ |
(189,559 |
) |
|
$ |
(517,743 |
) |
|
$ |
(389,850 |
) |
|
Net loss per common share - basic and diluted |
$ |
(2.29 |
) |
|
$ |
(1.61 |
) |
|
$ |
(4.29 |
) |
|
$ |
(3.32 |
) |
|
Weighted-average common shares used to compute basic and diluted net loss per common share |
|
120,896 |
|
|
|
117,772 |
|
|
|
120,646 |
|
|
|
117,428 |
|
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES (In thousands, except per share amounts) (Unaudited) |
||||||||||||||||
|
Three Months Ended |
|
Six Months Ended |
|||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to Non-GAAP research and development: |
|
|
|
|
|
|
|
|||||||||
|
$ |
205,712 |
|
|
$ |
182,635 |
|
|
$ |
375,605 |
|
|
$ |
368,534 |
|
|
Less: Stock-based compensation expenses |
|
(10,638 |
) |
|
|
(13,086 |
) |
|
|
(22,255 |
) |
|
|
(37,461 |
) |
|
|
$ |
195,074 |
|
|
$ |
169,549 |
|
|
$ |
353,350 |
|
|
$ |
331,073 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to Non-GAAP selling, general and administrative: |
|
|
|
|
|
|
|
|||||||||
GAAP Selling, general and administrative |
$ |
169,984 |
|
|
$ |
145,323 |
|
|
$ |
324,455 |
|
|
$ |
292,182 |
|
|
Less: Stock-based compensation expenses |
|
(19,833 |
) |
|
|
(18,992 |
) |
|
|
(37,509 |
) |
|
|
(50,307 |
) |
|
Non-GAAP Selling, general and administrative |
$ |
150,151 |
|
|
$ |
126,331 |
|
|
$ |
286,946 |
|
|
$ |
241,875 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to Non-GAAP operating loss: |
|
|
|
|
|
|
|
|||||||||
GAAP Operating loss |
$ |
(191,686 |
) |
|
$ |
(146,160 |
) |
|
$ |
(338,418 |
) |
|
$ |
(332,414 |
) |
|
Add: Stock-based compensation expenses |
|
30,471 |
|
|
|
32,078 |
|
|
|
59,764 |
|
|
|
87,768 |
|
|
Non-GAAP Operating loss |
$ |
(161,215 |
) |
|
$ |
(114,082 |
) |
|
$ |
(278,654 |
) |
|
$ |
(244,646 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to Non-GAAP Other (expense) income: |
|
|
|
|
|
|
|
|||||||||
GAAP Total other expense, net |
$ |
(82,987 |
) |
|
$ |
(42,171 |
) |
|
$ |
(175,611 |
) |
|
$ |
(55,192 |
) |
|
Add: Unrealized loss on marketable equity securities |
|
1,097 |
|
|
|
4,434 |
|
|
|
32,258 |
|
|
|
(42,582 |
) |
|
Non-GAAP Other expense, net |
$ |
(81,890 |
) |
|
$ |
(37,737 |
) |
|
$ |
(143,353 |
) |
|
$ |
(97,774 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to Non-GAAP net loss: |
|
|
|
|
|
|
|
|||||||||
GAAP Net loss |
$ |
(277,402 |
) |
|
$ |
(189,559 |
) |
|
$ |
(517,743 |
) |
|
$ |
(389,850 |
) |
|
Add: Stock-based compensation expenses |
|
30,471 |
|
|
|
32,078 |
|
|
|
59,764 |
|
|
|
87,768 |
|
|
Add (Less): Realized and unrealized loss (gain) on marketable equity securities |
|
1,097 |
|
|
|
4,434 |
|
|
|
32,258 |
|
|
|
(42,582 |
) |
|
Non-GAAP Net loss |
$ |
(245,834 |
) |
|
$ |
(153,047 |
) |
|
$ |
(425,721 |
) |
|
$ |
(344,664 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to Non-GAAP net loss per common share-basic and diluted: |
|
|
|
|
|
|
|
|||||||||
GAAP Net loss per common share - basic and diluted |
$ |
(2.29 |
) |
|
$ |
(1.61 |
) |
|
$ |
(4.29 |
) |
|
$ |
(3.32 |
) |
|
Add: Stock-based compensation expenses |
|
0.25 |
|
|
|
0.27 |
|
|
|
0.50 |
|
|
|
0.75 |
|
|
Add (Less): Realized and unrealized loss (gain) on marketable equity securities |
|
0.01 |
|
|
|
0.04 |
|
|
|
0.27 |
|
|
|
(0.36 |
) |
|
Non-GAAP Net loss per common share - basic and diluted |
$ |
(2.03 |
) |
|
$ |
(1.30 |
) |
|
$ |
(3.53 |
) |
|
$ |
(2.93 |
) |
|
Please note that the figures presented above may not sum exactly due to rounding |
RECONCILIATION OF GAAP TO NON-GAAP PRODUCT REVENUE GROWTH AT CONSTANT CURRENCY (Unaudited) |
||||||
|
|
|||||
|
Three Months
|
Six Months
|
||||
ONPATTRO net product revenue growth, as reported |
35 |
% |
|
35 |
% |
|
Less: Impact of foreign currency translation |
7 |
|
|
6 |
|
|
ONPATTRO net product revenue growth at constant currency |
42 |
% |
|
41 |
% |
|
|
|
|
|
|||
GIVLAARI net product revenue growth, as reported |
47 |
% |
|
45 |
% |
|
Less: Impact of foreign currency translation |
6 |
|
|
5 |
|
|
GIVLAARI net product revenue growth at constant currency |
53 |
% |
|
50 |
% |
|
|
|
|
|
|||
OXLUMO net product revenue growth, as reported |
(9 |
)% |
|
16 |
% |
|
Less: Impact of foreign currency translation |
5 |
|
|
6 |
|
|
OXLUMO net product revenue growth at constant currency |
(4 |
)% |
|
22 |
% |
|
|
|
|
|
|||
Total net product revenue growth, as reported |
33 |
% |
|
35 |
% |
|
Less: Impact of foreign currency translation |
7 |
|
|
6 |
|
|
Total net product revenue growth at constant currency |
40 |
% |
|
41 |
% |
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) (Unaudited) |
||||||||
|
|
|
|
|||||
ASSETS |
|
|
|
|||||
Current assets: |
|
|
|
|||||
Cash and cash equivalents |
$ |
575,558 |
|
|
$ |
819,975 |
|
|
Marketable debt securities |
|
1,504,154 |
|
|
|
1,548,617 |
|
|
Marketable equity securities |
|
30,901 |
|
|
|
66,972 |
|
|
Accounts receivable, net |
|
142,271 |
|
|
|
198,571 |
|
|
Inventory |
|
88,976 |
|
|
|
86,363 |
|
|
Prepaid expenses and other current assets |
|
129,778 |
|
|
|
88,078 |
|
|
Total current assets |
|
2,471,638 |
|
|
|
2,808,576 |
|
|
Property, plant and equipment, net |
|
508,201 |
|
|
|
501,958 |
|
|
Operating lease right-of-use assets |
|
223,921 |
|
|
|
231,675 |
|
|
Restricted investments |
|
49,390 |
|
|
|
40,891 |
|
|
Other assets |
|
77,267 |
|
|
|
60,204 |
|
|
Total assets |
$ |
3,330,417 |
|
|
$ |
3,643,304 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|||||
Current liabilities: |
|
|
|
|||||
Accounts payable |
$ |
52,418 |
|
|
$ |
73,426 |
|
|
Accrued expenses |
|
421,243 |
|
|
|
395,174 |
|
|
Operating lease liability |
|
41,236 |
|
|
|
40,548 |
|
|
Deferred revenue |
|
114,292 |
|
|
|
149,483 |
|
|
Liability related to the sale of future royalties |
|
28,496 |
|
|
|
37,079 |
|
|
Total current liabilities |
|
657,685 |
|
|
|
695,710 |
|
|
Operating lease liability, net of current portion |
|
272,016 |
|
|
|
281,347 |
|
|
Deferred revenue, net of current portion |
|
175,341 |
|
|
|
152,360 |
|
|
Long-term debt |
|
677,723 |
|
|
|
675,697 |
|
|
Liability related to the sale of future royalties, net of current portion |
|
1,214,311 |
|
|
|
1,151,024 |
|
|
Other liabilities |
|
157,301 |
|
|
|
98,963 |
|
|
Total liabilities |
|
3,154,377 |
|
|
|
3,055,101 |
|
|
Commitments and contingencies (Note 13) |
|
|
|
|||||
Stockholders’ equity: |
|
|
|
|||||
Preferred stock, |
|
— |
|
|
|
— |
|
|
Common stock, |
|
1,210 |
|
|
|
1,202 |
|
|
Additional paid-in capital |
|
6,172,990 |
|
|
|
6,058,453 |
|
|
Accumulated other comprehensive loss |
|
(42,224 |
) |
|
|
(33,259 |
) |
|
Accumulated deficit |
|
(5,955,936 |
) |
|
|
(5,438,193 |
) |
|
Total stockholders’ equity |
|
176,040 |
|
|
|
588,203 |
|
|
Total liabilities and stockholders’ equity |
$ |
3,330,417 |
|
|
$ |
3,643,304 |
|
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20220728005203/en/
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