Feb 23, 2023 Press Release for Alnylam
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Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Period Activity
Feb 23, 2023
− Achieved Fourth Quarter and Full Year 2022 Global Net Product Revenues of
− Submitted and Received Acceptance of Supplemental New Drug Application (sNDA) for ONPATTRO® (patisiran) for the Treatment of the Cardiomyopathy of ATTR Amyloidosis –
− Provides 2023 Combined Net Product Revenue Guidance of
“2022 was another year of strong progress at
Fourth Quarter 2022 and Recent Significant Corporate Highlights
Commercial Performance
Total TTR: ONPATTRO® (patisiran) & AMVUTTRA® (vutrisiran)
-
Achieved global net product revenues for ONPATTRO and AMVUTTRA for the fourth quarter of
$122 million and$69 million , respectively, representing 12% total TTR quarterly growth compared to Q3 2022, and full year 2022 revenues of$558 million and$94 million , respectively, representing 37% total TTR annual growth compared to full year 2021. -
Attained over 2,975 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of
December 31, 2022 , up from over 2,580 commercial patients as ofSeptember 30, 2022 , representing 15% total TTR quarterly growth and 46% total TTR annual growth vs. 2021. -
Received 760 Start Forms in the
U.S. for AMVUTTRA from launch throughDecember 31, 2022 , with ~53% representing new patients and ~47% representing patients switching from ONPATTRO.
GIVLAARI® (givosiran)
-
Achieved global net product revenues for the fourth quarter and full year 2022 of
$47 million and$173 million , respectively, representing quarterly and annual growth of 3% and 35% compared to Q3 2022 and full year 2021, respectively. -
Attained over 520 patients worldwide on commercial GIVLAARI treatment as of
December 31, 2022 , up from over 460 commercial patients as ofSeptember 30, 2022 , representing 13% quarterly growth and 47% annual growth vs. 2021.
OXLUMO® (lumasiran)
-
Achieved global net product revenues for the fourth quarter and full year 2022 of
$24 million and$70 million , respectively, representing quarterly and annual growth of 45% and 17% compared to Q3 2022 and full year 2021, respectively. -
Attained over 280 patients worldwide on commercial OXLUMO treatment as of
December 31, 2022 , up from over 230 commercial patients as ofSeptember 30, 2022 , representing 22% quarterly growth and 101% annual growth vs. 2021.
Leqvio® (inclisiran)
- Launch is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education.
R&D Highlights
Patisiran (the non-proprietary name for ONPATTRO), in development for the treatment of ATTR amyloidosis.
-
Submitted and received acceptance of the sNDA for ONPATTRO (patisiran) for the treatment of the cardiomyopathy of ATTR amyloidosis. The FDA has set an action date of
October 8, 2023 under the Prescription Drug User Fee Act (PDUFA).- In their file acceptance letter, the FDA stated that they have not identified any review issues. The Agency also noted that they are planning to hold an advisory committee meeting to discuss the application.
Vutrisiran (the non-proprietary name for AMVUTTRA), in development for the treatment of ATTR amyloidosis.
-
Announced topline results from the Randomized Treatment Extension (RTE) of the HELIOS-A Phase 3 study evaluating a biannual dosing regimen of vutrisiran.
- Non-inferiority of 50 mg biannual (vs. 25 mg quarterly) was established, as measured by TTR lowering through nine months in the RTE, along with an acceptable safety profile.
- However, the Company announces its strategic decision not to proceed with regulatory submissions for a biannual dosing regimen of vutrisiran and instead will focus on advancing ALN-TTRsc04, which has now entered the clinic and offers the potential for more durable and potent TTR silencing via annual dosing.
-
Received approval from the
Brazilian Health Regulatory Agency (ANVISA) for AMVUTTRA for the treatment of hATTR amyloidosis in adults.
Lumasiran (the non-proprietary name for OXLUMO), for the treatment of primary hyperoxaluria type 1 (PH1).
-
Based on the successful outcome of the ILLUMINATE-C study in children and adults with advanced PH1, received approval from the
U.S. FDA of an sNDA for OXLUMO, expanding the indication for the treatment of PH1 to lower urinary oxalate and plasma oxalate levels in pediatric and adult patients, and received approval from theEuropean Medicines Agency (EMA) of a Type II variation to include the ILLUMINATE-C data in the label.
Inclisiran (the non-proprietary name for Leqvio), for the treatment of hypercholesterolemia or mixed dyslipidemia, in collaboration with Novartis.
- New long-term data from the ORION-3 open-label study demonstrated effective and sustained reductions in LDL cholesterol over four years of treatment. At any time throughout the trial, approximately 80% of patients reached an LDL-C level of <70mg/dL. Data presented at AHA 2022.
Early- and mid-stage investigational RNAi therapeutic pipeline programs and RNAi platform.
- Completed enrollment in the KARDIA-1 Phase 2 monotherapy study of zilebesiran in patients with mild-to-moderate hypertension.
- Submitted Clinical Trial Authorization (CTA) filings for ALN-KHK for the treatment of type 2 diabetes, and ALN-PNP for the treatment of NASH in collaboration with Regeneron. Regeneron announced that dosing in a Phase 1 study of ALN-PNP has been initiated.
- Submitted a CTA application for ALN-TTRsc04, in development for the treatment of ATTR amyloidosis. The Company announces today that dosing in a Phase 1 study has been initiated.
- Announced pipeline prioritization decisions at 2022 R&D Day, including discontinuation of ALN-XDH in gout and lumasiran in recurrent renal stones, and pausing development of cemdisiran in IgA nephropathy.
Additional Business Updates
-
Appointed
Carolyn Bertozzi , Ph.D. to its Board of Directors. Also,Amy W. Schulman , previously the Lead Independent Director, assumed the role of Chair of the Board fromMichael W. Bonney , who has continued on the Board as a non-independent director.Mr. Bonney stepped down from his interim role as Executive Chair. -
Ranked #1 on
The Boston Globe ’s 2022 list of Great Places to Work in the “Largest Employer category. -
Ranked #2 in
Science Magazine ’s 2022 Top Employer survey, marking the fourth yearAlnylam was featured as one of the top three companies. - Recognized on Newsweek’s 2023 list of America’s Most Responsible Companies.
Upcoming Events
In early 2023:
-
Alnylam intends to complete enrollment in the KARDIA-2 Phase 2 study of zilebesiran. -
Alnylam intends to report preliminary topline results from the Phase 1 study of ALN-APP in patients with early onset Alzheimer’s Disease. -
Alnylam intends to initiate a Phase 1 study of ALN-KHK in normal healthy volunteers. -
Vir intends to report additional results from Part A of the MARCH trial evaluating the combination of ALN-HBV02 (VIR-2218) and VIR-3434, an anti-HBV monoclonal antibody, for the treatment of patients with chronic HBV infection in the first half of 2023.
- Vir also plans to report additional results from a Phase 2 study evaluating the combination of ALN-HBV02 (VIR-2218) and PEG-IFN alpha in the first half of 2023.
- Regeneron plans to initiate a Phase 2 study of ALN-HSD in patients with NASH.
Financial Results for the Quarter and Year Ended
Financial Highlights
|
Three Months Ended
|
|
Twelve Months Ended
|
||||||||||||
(In thousands, except per share amounts) |
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
Net product revenues |
$ |
261,675 |
|
|
$ |
198,514 |
|
|
$ |
894,329 |
|
|
$ |
662,138 |
|
Net revenue from collaborations |
$ |
70,645 |
|
|
$ |
59,625 |
|
|
$ |
134,912 |
|
|
$ |
180,953 |
|
Royalty revenue |
$ |
2,715 |
|
|
$ |
396 |
|
|
$ |
8,177 |
|
|
$ |
1,196 |
|
|
|
|
|
|
|
|
|
||||||||
GAAP Operating loss |
$ |
(188,614 |
) |
|
$ |
(194,561 |
) |
|
$ |
(785,072 |
) |
|
$ |
(708,652 |
) |
Non-GAAP Operating loss |
$ |
(145,847 |
) |
|
$ |
(149,979 |
) |
|
$ |
(554,423 |
) |
|
$ |
(542,935 |
) |
|
|
|
|
|
|
|
|
||||||||
GAAP Other expense, net |
$ |
(18,407 |
) |
|
$ |
(65,741 |
) |
|
$ |
(341,921 |
) |
|
$ |
(143,492 |
) |
Non-GAAP Other expense, net |
$ |
(25,203 |
) |
|
$ |
(60,163 |
) |
|
$ |
(232,023 |
) |
|
$ |
(199,187 |
) |
|
|
|
|
|
|
|
|
||||||||
GAAP Net loss |
$ |
(207,493 |
) |
|
$ |
(258,460 |
) |
|
$ |
(1,131,156 |
) |
|
$ |
(852,824 |
) |
Non-GAAP Net loss |
$ |
(171,522 |
) |
|
$ |
(208,300 |
) |
|
$ |
(790,609 |
) |
|
$ |
(742,802 |
) |
|
|
|
|
|
|
|
|
||||||||
GAAP Net loss per common share – basic and diluted |
$ |
(1.68 |
) |
|
$ |
(2.16 |
) |
|
$ |
(9.30 |
) |
|
$ |
(7.20 |
) |
Non-GAAP Net loss per common share – basic and diluted |
$ |
(1.39 |
) |
|
$ |
(1.74 |
) |
|
$ |
(6.50 |
) |
|
$ |
(6.27 |
) |
Net Product Revenues
|
Three Months Ended
|
|
Twelve Months Ended
|
||||||||
(In thousands) |
2022 |
|
2021 |
|
2022 |
|
2021 |
||||
ONPATTRO net product revenues |
$ |
122,221 |
|
$ |
138,630 |
|
$ |
557,608 |
|
$ |
474,737 |
AMVUTTRA net product revenues |
|
68,566 |
|
|
- |
|
|
93,795 |
|
|
- |
Total TTR net product revenues |
|
190,787 |
|
|
138,630 |
|
|
651,403 |
|
|
474,737 |
|
|
|
|
|
|
|
|
||||
GIVLAARI net product revenues |
|
47,058 |
|
|
40,679 |
|
|
173,144 |
|
|
127,815 |
OXLUMO net product revenues |
|
23,830 |
|
|
19,205 |
|
|
69,782 |
|
|
59,586 |
|
|
|
|
|
|
|
|
||||
Total net product revenues |
$ |
261,675 |
|
$ |
198,514 |
|
$ |
894,329 |
|
$ |
662,138 |
|
Year over Year % Growth |
||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
||||
|
As
|
|
At CER* |
|
As
|
|
At CER* |
Total TTR net product revenues |
38% |
|
48% |
|
37% |
|
46% |
|
|
|
|
|
|
|
|
GIVLAARI net product revenues |
16% |
|
22% |
|
35% |
|
41% |
OXLUMO net product revenues |
24% |
|
33% |
|
17% |
|
25% |
Total net product revenues |
32% |
|
41% |
|
35% |
|
43% |
* CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the three and twelve months ended |
-
Net product revenues increased 32% and 35% at actual currency during the three and twelve months ended
December 31, 2022 , respectively, compared to the same periods in 2021, and 41% and 43% at CER, respectively. The increases are primarily due to increased patients on our commercial TTR products as well as increased patients on GIVLAARI and OXLUMO.
Net Revenues from Collaborations
- Net revenues from collaborations increased 18% during the fourth quarter 2022, as compared to the prior year, primarily due to increased revenue from our collaboration with Regeneron from increased manufacturing activities.
-
Net revenues from collaborations decreased 25% for the twelve months ended
December 31, 2022 , as compared to the prior year, primarily due to a decrease in revenue recognized in connection with our collaboration agreements with Regeneron and Vir, attributed to reduced research and manufacturing activities and timing of reimbursable activities.
Operating Expenses
|
Three Months Ended
|
|
Twelve Months Ended
|
||||||||
(in thousands) |
2022 |
|
2021 |
|
2022 |
|
2021 |
||||
GAAP research and development expenses |
$ |
262,039 |
|
$ |
229,050 |
|
$ |
883,015 |
|
$ |
792,156 |
Non-GAAP research and development expenses |
$ |
245,095 |
|
$ |
210,513 |
|
$ |
790,854 |
|
$ |
723,741 |
|
|
|
|
|
|
|
|
||||
GAAP selling, general and administrative expenses |
$ |
210,344 |
|
$ |
186,382 |
|
$ |
770,658 |
|
$ |
620,639 |
Non-GAAP selling, general and administrative expenses |
$ |
184,521 |
|
$ |
160,337 |
|
$ |
632,170 |
|
$ |
523,337 |
Research & Development (R&D) Expenses
-
GAAP and non-GAAP R&D expenses increased during the three and twelve months ended
December 31, 2022 , compared to the same periods in 2021, primarily due to increases in headcount to support our R&D pipeline, development expenses associated with the KARDIA-1 and KARDIA-2 zilebesiran Phase 2 studies, and manufacturing and research related expenses associated with our pre-clinical and developmental activities. GAAP R&D expenses further increased during the twelve month period due to increased stock-based compensation expense related to the accounting for certain performance-based awards that vested during the period.
Selling, General & Administrative (SG&A) Expenses
-
GAAP and non-GAAP SG&A expenses increased during the three and twelve months ended
December 31, 2022 , compared to the same periods in 2021, primarily due to increased headcount and other strategic investments in support of the global launch of AMVUTTRA and other expenses to support our strategic growth. GAAP SG&A expenses further increased during the twelve month period due to stock-based compensation expense related to the accounting for certain performance-based awards that vested during the period.
Other Financial Highlights
-
GAAP other expense, net, decreased during the fourth quarter 2022, as compared to the prior year, primarily due to foreign currency gains as a result of the
U.S. Dollar weakening against key global currencies, increased interest income, and unrealized gains on marketable equity securities. -
GAAP other expense, net, increased during the twelve months ended
December 31, 2022 , compared to the same period in 2021, primarily due to a loss on the extinguishment of theBlackstone credit agreement, increased realized and unrealized losses on our marketable equity securities, and an increased loss from the fair value adjustment on the development derivative liability, offset by an increase in interest income. -
Cash, cash equivalents and marketable securities were
$2.19 billion as ofDecember 31, 2022 compared to$2.44 billion as ofDecember 31, 2021 with the decrease primarily due to our year-to-date operating loss in 2022. This decrease was largely offset by approximately$265 million received from employee option award exercises and approximately$135 million received from the issuance of convertible debt, net of repayment borrowings, inclusive of prepayment premiums under the credit facility, the purchase of capped call transactions, and underwriter fees.
The adjustments to the non-GAAP measures provided in the financial results above and in the financial guidance below are described under “Use of Non-GAAP Financial Measures” later in this press release. A reconciliation of our GAAP to non-GAAP results presented in this release is included in the tables of this press release.
2023 Financial Guidance1
Full year
Combined net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO1,2 |
|
Net Product Revenue Growth vs. 2022 at reported Fx rates1 |
34% to 44% |
Net Product Revenue Growth vs. 2022 at constant exchange rates* |
34% to 44% |
Net revenues from collaborations and royalties |
|
GAAP R&D and SG&A expenses |
|
Non-GAAP R&D and SG&A expenses3 |
|
1 Uses
2 Assumes
3 Excludes
* CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the twelve months ended |
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 and expenses 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, realized and unrealized (gains) losses on marketable equity securities and loss on the extinguishment of debt. 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. The Company has excluded the loss on the extinguishment of debt because the Company believes the item is a non-recurring transaction outside the ordinary course of the Company’s business.
Percentage changes in revenue growth at CER, also a non-GAAP financial measure, 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 historical GAAP and non-GAAP measures presented in this release is provided later in this press release.
Conference Call Information
Management will provide an update on the Company and discuss fourth quarter and year-end 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 is approved in
About AMVUTTRA® (vutrisiran)
AMVUTTRA® (vutrisiran) is an RNAi therapeutic approved in
About GIVLAARI® (givosiran)
GIVLAARI is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) approved in
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
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
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, expectations regarding Alnylam’s aspiration to become a leading biotech company and the planned achievement of its “Alnylam P5x25” strategy, the potential for
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. Patisiran has not been approved by any regulatory agency for the treatment of ATTR amyloidosis with cardiomyopathy. No conclusions can or should be drawn regarding its safety or effectiveness in treating cardiomyopathy in this population. There is no guarantee that any investigational therapeutics or expanded uses of commercial products will successfully complete clinical development or gain health authority approval.
CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) |
|||||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
||||||||||||
|
2022 |
|
2021 |
|
2022 |
|
2021 |
||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
261,675 |
|
|
$ |
198,514 |
|
|
$ |
894,329 |
|
|
$ |
662,138 |
|
Net revenues from collaborations |
|
70,645 |
|
|
|
59,625 |
|
|
|
134,912 |
|
|
|
180,953 |
|
Royalty revenue |
|
2,715 |
|
|
|
396 |
|
|
|
8,177 |
|
|
|
1,196 |
|
Total revenues |
|
335,035 |
|
|
|
258,535 |
|
|
|
1,037,418 |
|
|
|
844,287 |
|
|
|
|
|
|
|
|
|
||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
|
46,172 |
|
|
|
33,635 |
|
|
|
140,174 |
|
|
|
115,005 |
|
Cost of collaborations and royalties |
|
5,094 |
|
|
|
4,029 |
|
|
|
28,643 |
|
|
|
25,139 |
|
Research and development |
|
262,039 |
|
|
|
229,050 |
|
|
|
883,015 |
|
|
|
792,156 |
|
Selling, general and administrative |
|
210,344 |
|
|
|
186,382 |
|
|
|
770,658 |
|
|
|
620,639 |
|
Total operating costs and expenses |
|
523,649 |
|
|
|
453,096 |
|
|
|
1,822,490 |
|
|
|
1,552,939 |
|
Loss from operations |
|
(188,614 |
) |
|
|
(194,561 |
) |
|
|
(785,072 |
) |
|
|
(708,652 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
||||||||
Interest expense |
|
(29,913 |
) |
|
|
(36,816 |
) |
|
|
(155,968 |
) |
|
|
(143,021 |
) |
Other (expense) income, net |
|
11,506 |
|
|
|
(28,925 |
) |
|
|
(109,367 |
) |
|
|
(471 |
) |
Loss on the extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
(76,586 |
) |
|
|
— |
|
Total other (expense) income, net |
|
(18,407 |
) |
|
|
(65,741 |
) |
|
|
(341,921 |
) |
|
|
(143,492 |
) |
Loss before income taxes |
|
(207,021 |
) |
|
|
(260,302 |
) |
|
|
(1,126,993 |
) |
|
|
(852,144 |
) |
Provision for income taxes |
|
(472 |
) |
|
|
1,842 |
|
|
|
(4,163 |
) |
|
|
(680 |
) |
Net loss |
$ |
(207,493 |
) |
|
$ |
(258,460 |
) |
|
$ |
(1,131,156 |
) |
|
$ |
(852,824 |
) |
Net loss per common share — basic and diluted |
$ |
(1.68 |
) |
|
$ |
(2.16 |
) |
|
$ |
(9.30 |
) |
|
$ |
(7.20 |
) |
Weighted-average common shares used to compute basic and diluted net loss per common share |
|
123,266 |
|
|
|
119,773 |
|
|
|
121,689 |
|
|
|
118,451 |
|
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES (In thousands, except per share amounts) (Unaudited) |
|||||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
||||||||||||
|
2022 |
|
20211 |
|
2022 |
|
20211 |
||||||||
Reconciliation of GAAP to Non-GAAP research and development: |
|
|
|
|
|
|
|
||||||||
|
$ |
262,039 |
|
|
$ |
229,050 |
|
|
$ |
883,015 |
|
|
$ |
792,156 |
|
Less: Stock-based compensation expenses |
|
(16,944 |
) |
|
|
(18,537 |
) |
|
|
(92,161 |
) |
|
|
(68,415 |
) |
|
$ |
245,095 |
|
|
$ |
210,513 |
|
|
$ |
790,854 |
|
|
$ |
723,741 |
|
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP selling, general and administrative: |
|
|
|
|
|
|
|
||||||||
GAAP Selling, general and administrative |
$ |
210,344 |
|
|
$ |
186,382 |
|
|
$ |
770,658 |
|
|
$ |
620,639 |
|
Less: Stock-based compensation expenses |
|
(25,823 |
) |
|
|
(26,045 |
) |
|
|
(138,488 |
) |
|
|
(97,302 |
) |
Non-GAAP Selling, general and administrative |
$ |
184,521 |
|
|
$ |
160,337 |
|
|
$ |
632,170 |
|
|
$ |
523,337 |
|
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP operating loss: |
|
|
|
|
|
|
|
||||||||
GAAP operating loss |
$ |
(188,614 |
) |
|
$ |
(194,561 |
) |
|
$ |
(785,072 |
) |
|
$ |
(708,652 |
) |
Add: Stock-based compensation expenses |
|
42,767 |
|
|
|
44,582 |
|
|
|
230,649 |
|
|
|
165,717 |
|
Non-GAAP Operating loss |
$ |
(145,847 |
) |
|
$ |
(149,979 |
) |
|
$ |
(554,423 |
) |
|
$ |
(542,935 |
) |
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP Other (expense) income: |
|
|
|
|
|
|
|
||||||||
GAAP Total other expense, net |
$ |
(18,407 |
) |
|
$ |
(65,741 |
) |
|
$ |
(341,921 |
) |
|
$ |
(143,492 |
) |
(Less) Add: Realized and unrealized (gain) loss on marketable equity securities |
|
(6,796 |
) |
|
|
5,578 |
|
|
|
33,312 |
|
|
|
(55,695 |
) |
Add: Loss on the extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
76,586 |
|
|
|
— |
|
Non-GAAP Other expense, net |
$ |
(25,203 |
) |
|
$ |
(60,163 |
) |
|
$ |
(232,023 |
) |
|
$ |
(199,187 |
) |
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP net loss: |
|
|
|
|
|
|
|
||||||||
GAAP Net loss |
$ |
(207,493 |
) |
|
$ |
(258,460 |
) |
|
$ |
(1,131,156 |
) |
|
$ |
(852,824 |
) |
Add: Stock-based compensation expenses |
|
42,767 |
|
|
|
44,582 |
|
|
|
230,649 |
|
|
|
165,717 |
|
(Less) Add: Realized and unrealized (gain) loss on marketable equity securities |
|
(6,796 |
) |
|
|
5,578 |
|
|
|
33,312 |
|
|
|
(55,695 |
) |
Add: Loss on the extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
76,586 |
|
|
|
— |
|
Non-GAAP Net loss |
$ |
(171,522 |
) |
|
$ |
(208,300 |
) |
|
$ |
(790,609 |
) |
|
$ |
(742,802 |
) |
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP net loss per common share-basic and diluted: |
|
|
|
|
|
|
|
||||||||
GAAP Net loss per common share - basic and diluted |
$ |
(1.68 |
) |
|
$ |
(2.16 |
) |
|
$ |
(9.30 |
) |
|
$ |
(7.20 |
) |
Add: Stock-based compensation expenses |
|
0.35 |
|
|
|
0.37 |
|
|
|
1.90 |
|
|
|
1.40 |
|
(Less) Add: Realized and unrealized (gain) loss on marketable equity securities |
|
(0.06 |
) |
|
|
0.05 |
|
|
|
0.27 |
|
|
|
(0.47 |
) |
Add: Loss on the extinguishment of debt |
|
— |
|
|
|
— |
|
|
|
0.63 |
|
|
|
— |
|
Non-GAAP Net loss per common share - basic and diluted |
$ |
(1.39 |
) |
|
$ |
(1.74 |
) |
|
$ |
(6.50 |
) |
|
$ |
(6.27 |
) |
1 Beginning in 2022, presentations of non-GAAP financial measures will not include adjustments for upfront payment on license and collaboration agreement. Non-GAAP financial measures for three- and twelve-months ended |
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
|
|
Twelve Months
|
Total TTR net product revenue growth, as reported |
38% |
|
37% |
Add: Impact of foreign currency translation |
10 |
|
9 |
Total TTR net product revenue growth at constant currency |
48% |
|
46% |
|
|
|
|
GIVLAARI net product revenue growth, as reported |
16% |
|
35% |
Add: Impact of foreign currency translation |
6 |
|
6 |
GIVLAARI net product revenue growth at constant currency |
22% |
|
41% |
|
|
|
|
OXLUMO net product revenue growth, as reported |
24% |
|
17% |
Add: Impact of foreign currency translation |
9 |
|
8 |
OXLUMO net product revenue growth at constant currency |
33% |
|
25% |
|
|
|
|
Total net product revenue growth, as reported |
32% |
|
35% |
Add: Impact of foreign currency translation |
9 |
|
8 |
Total net product revenue growth at constant currency |
41% |
|
43% |
|
|
|
|
Total revenue growth, as reported |
30% |
|
23% |
Add: Impact of foreign currency translation |
7 |
|
6 |
Total revenue growth at constant currency |
37% |
|
29% |
CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) |
|||||||
|
|
|
|
||||
ASSETS |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
866,394 |
|
|
$ |
819,975 |
|
Marketable debt securities |
|
1,297,890 |
|
|
|
1,548,617 |
|
Marketable equity securities |
|
28,122 |
|
|
|
66,972 |
|
Accounts receivable, net |
|
237,963 |
|
|
|
198,571 |
|
Inventory |
|
128,962 |
|
|
|
86,363 |
|
Prepaid expenses and other current assets |
|
132,916 |
|
|
|
88,078 |
|
Total current assets |
|
2,692,247 |
|
|
|
2,808,576 |
|
Property, plant and equipment, net |
|
523,494 |
|
|
|
501,958 |
|
Operating lease right-of-use assets |
|
215,136 |
|
|
|
231,675 |
|
Restricted investments |
|
49,390 |
|
|
|
40,891 |
|
Other assets |
|
66,092 |
|
|
|
60,204 |
|
Total assets |
$ |
3,546,359 |
|
|
$ |
3,643,304 |
|
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
98,094 |
|
|
$ |
73,426 |
|
Accrued expenses |
|
545,460 |
|
|
|
395,174 |
|
Operating lease liability |
|
41,967 |
|
|
|
40,548 |
|
Deferred revenue |
|
42,105 |
|
|
|
149,483 |
|
Liability related to the sale of future royalties |
|
40,289 |
|
|
|
37,079 |
|
Total current liabilities |
|
767,915 |
|
|
|
695,710 |
|
Operating lease liability, net of current portion |
|
261,339 |
|
|
|
281,347 |
|
Deferred revenue, net of current portion |
|
193,791 |
|
|
|
152,360 |
|
Convertible debt |
|
1,016,942 |
|
|
|
— |
|
Long-term debt |
|
— |
|
|
|
675,697 |
|
Liability related to the sale of future royalties, net of current portion |
|
1,252,015 |
|
|
|
1,151,024 |
|
Other liabilities |
|
212,580 |
|
|
|
98,963 |
|
Total liabilities |
|
3,704,582 |
|
|
|
3,055,101 |
|
Commitments and contingencies (Note 14) |
|
|
|
||||
Stockholders’ (deficit) equity: |
|
|
|
||||
Preferred stock, |
|
— |
|
|
|
— |
|
Common stock, |
|
1,240 |
|
|
|
1,202 |
|
Additional paid-in capital |
|
6,454,540 |
|
|
|
6,058,453 |
|
Accumulated other comprehensive loss |
|
(44,654 |
) |
|
|
(33,259 |
) |
Accumulated deficit |
|
(6,569,349 |
) |
|
|
(5,438,193 |
) |
Total stockholders’ (deficit) equity |
|
(158,223 |
) |
|
|
588,203 |
|
Total liabilities and stockholders’ equity |
$ |
3,546,359 |
|
|
$ |
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/20230223005143/en/
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