Nov 02, 2023 Press Release for Alnylam
Alnylam Pharmaceuticals Reports Third Quarter 2023 Financial Results and Highlights Recent Period Activity
Nov 02, 2023
− Achieved Third Quarter 2023 Global Net Product Revenues of
− Received Complete Response Letter from
− Company Remains On Track to Report Topline Results from HELIOS-B Phase 3 Study in Early 2024 –
– Reported Positive Topline Results from KARDIA-1 Phase 2 Study of Zilebesiran –
− Updated 2023 Guidance for Revenues from Collaborations and Royalties to
“We continued to deliver strong commercial results in the third quarter, with the successful launch of AMVUTTRA contributing to 35% year-over-year growth in net product revenues,” said
Third Quarter 2023 and Recent Significant Corporate Highlights
Commercial Performance
Total TTR: ONPATTRO® (patisiran) & AMVUTTRA® (vutrisiran)
-
Achieved global net product revenues for ONPATTRO and AMVUTTRA for the third quarter of
$82 million and$149 million , respectively, representing 35% total TTR reported year-over-year growth compared to Q3 2022. -
Attained over 3,790 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of
September 30, 2023 .
Total Ultra-Rare: GIVLAARI® (givosiran) & OXLUMO® (lumasiran)
-
Achieved global net product revenues for GIVLAARI and OXLUMO for the third quarter of
$54 million and$29 million , respectively, representing 33% total Ultra-Rare reported year-over-year growth compared to Q3 2022. -
Attained over 625 patients worldwide on commercial GIVLAARI treatment as of
September 30, 2023 . -
Attained over 375 patients worldwide on commercial OXLUMO treatment as of
September 30, 2023 .
Leqvio® (inclisiran)
-
Leqvio launch in the
U.S. and other markets is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education. In theU.S. , Leqvio is covered at or near label for 76% of patients. More than 55% of Leqvio source of business in theU.S. is now through "Buy and Bill" acquisition mode. FDA expanded the label to include primary hyperlipidemia (patients at increased risk of ASCVD) and the removal of four adverse reactions from the safety section as well as Limitations of Use. In Q3 2023, Leqvio was approved inChina and inJapan and is now approved in 93 countries.
R&D Highlights
Reported positive topline results from the KARDIA-1 Phase 2 dose-ranging study of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high cardiovascular risk.
Published results from Phase 1 study of zilebesiran in the
Reported updated positive interim results for the ongoing single ascending dose portion of the Phase 1 study of ALN-APP in patients with early-onset Alzheimer’s disease at the 2023 Alzheimer’s
-
Based on the achievement of specified clinical proof-of-principle criteria for the Phase 1 ALN-APP program,
Alnylam received a$100 million milestone payment from Regeneron.
Presented new 24-month results from an interim analysis of the open-label extension period of the APOLLO-B Phase 3 study of patisiran in patients with the cardiomyopathy of transthyretin-mediated amyloidosis at the Heart Failure Society of America Annual
Published results from Phase 3 APOLLO-B study of patisiran in the
Sanofi reported positive data for fitusiran, in development for the treatment of hemophilia A or B, with or without inhibitors, from the Phase 3 open-label extension study (ATLAS-OLE).
- Sanofi is currently in discussions with the FDA regarding filing in 2024.
Additional Business Updates
- Entered into a global strategic collaboration with Roche for the co-development and co-commercialization of zilebesiran.
- Recognized by Science magazine as a Top Employer for the fifth consecutive year.
Upcoming Events
In addition, in late 2023:
-
Alnylam intends to report topline results from the Phase 1 study of ALN-TTRsc04. -
Alnylam intends to report topline results from the Phase 1 study of ALN-KHK. -
Vir is conducting multiple trials evaluating the potential for ALN-HBV02 (VIR-2218) and VIR-3434 to achieve a functional cure for chronic hepatitis B. Phase 2 data readouts are on track for Q4 2023.
- Vir also announced that initial Phase 2 data readouts for the SOLSTICE trial evaluating ALN-HBV02 (VIR-2218) and VIR-3434 as monotherapy and in combination for the treatment of people living with chronic hepatitis delta, the most aggressive form of viral hepatitis, are expected in Q4 2023.
Financial Results for the Quarter Ended
|
Three Months Ended
|
|||||
(in thousands, except per share amounts) |
2023 |
|
|
2022 |
|
|
Net product revenues |
$ |
313,153 |
|
$ |
232,267 |
|
Net revenue from collaborations |
$ |
427,472 |
|
$ |
29,297 |
|
Royalty revenue |
$ |
9,905 |
|
$ |
2,742 |
|
|
|
|
|
|||
GAAP Operating income (loss) |
$ |
213,867 |
|
$ |
(258,040 |
) |
Non-GAAP Operating income (loss) |
$ |
277,804 |
|
$ |
(129,922 |
) |
|
|
|
|
|||
GAAP Net income (loss) |
$ |
147,753 |
|
$ |
(405,920 |
) |
Non-GAAP Net income (loss) |
$ |
228,534 |
|
$ |
(193,366 |
) |
|
|
|
|
|||
GAAP net income (loss) per common share - basic |
$ |
1.18 |
|
$ |
(3.32 |
) |
Non-GAAP net income (loss) per common share - basic |
$ |
1.83 |
|
$ |
(1.58 |
) |
|
|
|
|
|||
GAAP net income (loss) per common share - diluted |
$ |
1.15 |
|
$ |
(3.32 |
) |
Non-GAAP net income (loss) per common share - diluted |
$ |
1.74 |
|
$ |
(1.58 |
) |
|
|
|
|
|||
* 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
|
|
Year over Year %
|
||||||||
(in thousands, except percentages) |
|
2023 |
|
|
2022 |
|
As Reported |
|
At CER* |
||
ONPATTRO net product revenues |
$ |
81,589 |
|
$ |
144,950 |
|
(44 |
)% |
|
(46 |
)% |
AMVUTTRA net product revenues |
|
148,680 |
|
|
25,229 |
|
489 |
% |
|
488 |
% |
Total TTR net product revenues |
$ |
230,269 |
|
$ |
170,179 |
|
35 |
% |
|
34 |
% |
|
|
|
|
|
|
|
|
||||
GIVLAARI net product revenues |
|
54,148 |
|
|
45,659 |
|
19 |
% |
|
17 |
% |
OXLUMO net product revenues |
|
28,736 |
|
|
16,429 |
|
75 |
% |
|
69 |
% |
Total net product revenues |
$ |
313,153 |
|
$ |
232,267 |
|
35 |
% |
|
33 |
% |
|
|
|
|
|
|
|
|
||||
* CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the third quarter 2022. CER is a Non-GAAP measure. 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 increased 35% during the third quarter 2023, as compared to the prior year, and 33% at CER. The increase is primarily related to growth in our TTR product revenues driven by the launch of AMVUTTRA in the third quarter of 2022 as well as increased patients on GIVLAARI and OXLUMO therapies. The increase was offset by a decrease of demand for ONPATTRO due to patient switched to AMVUTTRA.
Net Revenues from Collaborations
-
The increase in net revenues from collaborations, as compared to the prior year, is due to revenue related to our collaborations with Roche and Regeneron. During the quarter, we recognized
$310 million of revenue from the upfront payment received from Roche and$65 million in connection with our Regeneron Collaboration. The$65 million of revenue is a cumulative adjustment from the$100 million milestone received for achieving certain criteria during early clinical development for our CNS program, ALN-APP.
Operating Expenses
|
Three Months Ended
|
|
2023 vs 2022 |
|||||||
(in thousands, except percentages) |
|
2023 |
|
|
|
2022 |
|
|
% Change* |
|
Cost of goods sold |
$ |
79,473 |
|
|
$ |
36,507 |
|
|
118 |
% |
Cost of goods sold as a percentage of net product revenues |
|
25.4 |
% |
|
|
15.7 |
% |
|
9.7 |
% |
|
|
|
|
|
|
|||||
Cost of collaborations |
$ |
4,836 |
|
|
$ |
4,609 |
|
|
5 |
% |
|
|
|
|
|
|
|||||
GAAP research and development expenses |
$ |
253,179 |
|
|
$ |
245,371 |
|
|
3 |
% |
Non-GAAP research and development expenses |
$ |
224,024 |
|
|
$ |
192,409 |
|
|
16 |
% |
|
|
|
|
|
|
|||||
GAAP selling, general and administrative expenses |
$ |
199,175 |
|
|
$ |
235,859 |
|
|
(16 |
)% |
Non-GAAP selling, general and administrative expenses |
$ |
164,393 |
|
|
$ |
160,703 |
|
|
2 |
% |
|
|
|
|
|
|
|||||
*For dollar values, we calculate the percentage of change during Q3 2023 compared to Q3 2022. For cost of goods sold as a percentage of net product revenues, we calculate the basis point change during Q3 2023 compared to Q3 2022. |
Cost of Goods Sold
- Cost of goods sold as a percent of net product revenues increased during the third quarter 2023, as compared to the prior year, primarily due to recording an impairment of ONPATTRO inventory that had been manufactured for future demand associated with the ATTR cardiomyopathy indication for patisiran for which we did not receive regulatory approval.
Research & Development (R&D) Expenses
- GAAP and non-GAAP R&D expenses increased during the third quarter 2023, as compared to the prior year, primarily due to increased costs related to clinical activities and increased headcount to support our R&D pipeline and an expense for the achievement of a certain clinical milestone payable to a partner. Increased GAAP R&D expenses were offset by decreased stock-based compensation expense related to the accounting for certain performance-based awards that vested in 2022.
Selling, General & Administrative (SG&A) Expenses
- GAAP SG&A expenses decreased during the third quarter 2023, as compared to the prior year, primarily due to decreased stock-based compensation expense related to the accounting for certain performance-based awards that vested in 2022. Non-GAAP SG&A expenses increased in the third quarter of 2023, compared to 2022, primarily due to increased headcount and other investments supporting our strategic growth including the global launch of AMVUTTRA.
Other Financial Highlights
-
Cash, cash equivalents and marketable securities were
$2.41 billion as ofSeptember 30, 2023 compared to$2.19 billion as ofDecember 31, 2022 with the increase primarily related to the$310 million upfront payment received from Roche in connection with our partnership to co-develop and co-commercialize zilebesiran, offset by our operating loss year-to-date.
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 at the end of this press release.
2023 Financial Guidance
Full year 2023 financial guidance has been updated as follows:
|
|
Provided |
Updated |
Combined net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO1 |
|
|
Unchanged |
Net Product Revenue Growth vs. 2022 at reported FX rates1 |
|
34% to 44% |
Unchanged |
Net Product Revenue Growth vs. 2022 at CER* |
|
34% to 44% |
Unchanged |
Net revenues from collaborations and royalties |
|
|
|
GAAP R&D and SG&A expenses |
|
|
Unchanged |
Non-GAAP R&D and SG&A expenses2 |
|
|
Unchanged |
|
|
|
|
1 Uses |
|||
2 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 certain losses 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 non-GAAP financial measures we present include Non-GAAP Operating income (loss), Non-GAAP Net income (loss), Non-GAAP Net income (loss) per common share - basic, Non-GAAP Net income (loss) per common share - diluted and Non-GAAP R&D and SG&A expenses. 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, 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 third quarter 2023 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 (givosiran) 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 Pharmaceuticals
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.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts) (Unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
|
|
|
|
|
|
||||||||
Statements of Operations |
|
|
|
|
|
|
|
||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
313,153 |
|
|
$ |
232,267 |
|
|
$ |
895,186 |
|
|
$ |
632,654 |
|
Net revenues from collaborations |
|
427,472 |
|
|
|
29,297 |
|
|
|
469,778 |
|
|
|
64,267 |
|
Royalty revenue |
|
9,905 |
|
|
|
2,742 |
|
|
|
23,610 |
|
|
|
5,462 |
|
Total revenues |
|
750,530 |
|
|
|
264,306 |
|
|
|
1,388,574 |
|
|
|
702,383 |
|
|
|
|
|
|
|
|
|
||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
|
79,473 |
|
|
|
36,507 |
|
|
|
196,241 |
|
|
|
94,002 |
|
Cost of collaborations and royalties |
|
4,836 |
|
|
|
4,609 |
|
|
|
28,307 |
|
|
|
23,549 |
|
Research and development |
|
253,179 |
|
|
|
245,371 |
|
|
|
732,274 |
|
|
|
620,976 |
|
Selling, general and administrative |
|
199,175 |
|
|
|
235,859 |
|
|
|
597,523 |
|
|
|
560,314 |
|
Total operating costs and expenses |
|
536,663 |
|
|
|
522,346 |
|
|
|
1,554,345 |
|
|
|
1,298,841 |
|
Income (loss) from operations |
|
213,867 |
|
|
|
(258,040 |
) |
|
|
(165,771 |
) |
|
|
(596,458 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
||||||||
Interest expense |
|
(30,893 |
) |
|
|
(41,084 |
) |
|
|
(89,883 |
) |
|
|
(126,055 |
) |
Interest income |
|
25,425 |
|
|
|
7,820 |
|
|
|
65,155 |
|
|
|
10,731 |
|
Other expense, net |
|
(57,658 |
) |
|
|
(38,053 |
) |
|
|
(105,331 |
) |
|
|
(131,604 |
) |
Loss on the extinguishment of debt |
|
— |
|
|
|
(76,586 |
) |
|
|
— |
|
|
|
(76,586 |
) |
Total other expense, net |
|
(63,126 |
) |
|
|
(147,903 |
) |
|
|
(130,059 |
) |
|
|
(323,514 |
) |
Income (loss) before income taxes |
|
150,741 |
|
|
|
(405,943 |
) |
|
|
(295,830 |
) |
|
|
(919,972 |
) |
(Provision for) benefit from income taxes |
|
(2,988 |
) |
|
|
23 |
|
|
|
(6,542 |
) |
|
|
(3,691 |
) |
Net income (loss) |
$ |
147,753 |
|
|
$ |
(405,920 |
) |
|
$ |
(302,372 |
) |
|
$ |
(923,663 |
) |
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per common share - basic |
$ |
1.18 |
|
|
$ |
(3.32 |
) |
|
$ |
(2.43 |
) |
|
$ |
(7.62 |
) |
Net income (loss) per common share - diluted |
$ |
1.15 |
|
|
$ |
(3.32 |
) |
|
$ |
(2.43 |
) |
|
$ |
(7.62 |
) |
|
|
|
|
|
|
|
|
||||||||
Weighted-average common shares- basic |
|
125,220 |
|
|
|
122,166 |
|
|
|
124,667 |
|
|
|
121,158 |
|
Weighted-average common shares- diluted |
|
131,337 |
|
|
|
122,166 |
|
|
|
124,667 |
|
|
|
121,158 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) (Unaudited) |
|||||||
|
|
|
|||||
ASSETS |
|
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
1,033,024 |
|
|
$ |
866,394 |
|
Marketable debt securities |
|
1,362,843 |
|
|
|
1,297,890 |
|
Marketable equity securities |
|
10,411 |
|
|
|
28,122 |
|
Accounts receivable, net |
|
325,445 |
|
|
|
237,963 |
|
Inventory |
|
95,771 |
|
|
|
128,962 |
|
Prepaid expenses and other current assets |
|
157,958 |
|
|
|
132,916 |
|
Total current assets |
|
2,985,452 |
|
|
|
2,692,247 |
|
Property, plant and equipment, net |
|
525,591 |
|
|
|
523,494 |
|
Operating lease right-of-use assets |
|
203,485 |
|
|
|
215,136 |
|
Restricted investments |
|
49,390 |
|
|
|
49,390 |
|
Other assets |
|
75,155 |
|
|
|
66,092 |
|
Total assets |
$ |
3,839,073 |
|
|
$ |
3,546,359 |
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
73,840 |
|
|
$ |
98,094 |
|
Accrued expenses |
|
713,094 |
|
|
|
545,460 |
|
Operating lease liability |
|
41,516 |
|
|
|
41,967 |
|
Deferred revenue |
|
77,140 |
|
|
|
42,105 |
|
Liability related to the sale of future royalties |
|
44,195 |
|
|
|
40,289 |
|
Total current liabilities |
|
949,785 |
|
|
|
767,915 |
|
Operating lease liability, net of current portion |
|
247,711 |
|
|
|
261,339 |
|
Deferred revenue, net of current portion |
|
196,086 |
|
|
|
193,791 |
|
Convertible debt |
|
1,019,809 |
|
|
|
1,016,942 |
|
Liability related to the sale of future royalties, net of current portion |
|
1,310,814 |
|
|
|
1,252,015 |
|
Other liabilities |
|
280,734 |
|
|
|
212,580 |
|
Total liabilities |
|
4,004,939 |
|
|
|
3,704,582 |
|
Commitments and contingencies (Note 13) |
|
|
|
||||
Stockholders’ deficit: |
|
|
|
||||
Preferred stock, |
|
— |
|
|
|
— |
|
Common stock, |
|
1,255 |
|
|
|
1,240 |
|
Additional paid-in capital |
|
6,736,939 |
|
|
|
6,454,540 |
|
Accumulated other comprehensive loss |
|
(32,339 |
) |
|
|
(44,654 |
) |
Accumulated deficit |
|
(6,871,721 |
) |
|
|
(6,569,349 |
) |
Total stockholders’ deficit |
|
(165,866 |
) |
|
|
(158,223 |
) |
Total liabilities and stockholders’ deficit |
$ |
3,839,073 |
|
|
$ |
3,546,359 |
|
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
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES (In thousands, except per share amounts) (Unaudited) |
|||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP research and development: |
|
|
|
|
|
|
|
||||||||
GAAP research and development |
$ |
253,179 |
|
|
$ |
245,371 |
|
|
$ |
732,274 |
|
|
$ |
620,976 |
|
Less: Stock-based compensation expenses |
|
(29,155 |
) |
|
|
(52,962 |
) |
|
|
(78,188 |
) |
|
|
(75,217 |
) |
Non-GAAP research and development |
$ |
224,024 |
|
|
$ |
192,409 |
|
|
$ |
654,086 |
|
|
$ |
545,759 |
|
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP selling, general and administrative: |
|
|
|
|
|
|
|||||||||
GAAP selling, general and administrative |
$ |
199,175 |
|
|
$ |
235,859 |
|
|
$ |
597,523 |
|
|
$ |
560,314 |
|
Less: Stock-based compensation expenses |
|
(34,782 |
) |
|
|
(75,156 |
) |
|
|
(101,498 |
) |
|
|
(112,665 |
) |
Non-GAAP selling, general and administrative |
$ |
164,393 |
|
|
$ |
160,703 |
|
|
$ |
496,025 |
|
|
$ |
447,649 |
|
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP operating income (loss): |
|
|
|
|
|
|
|
||||||||
GAAP operating income (loss) |
$ |
213,867 |
|
|
$ |
(258,040 |
) |
|
$ |
(165,771 |
) |
|
$ |
(596,458 |
) |
Add: Stock-based compensation expenses |
|
63,937 |
|
|
|
128,118 |
|
|
|
179,686 |
|
|
|
187,882 |
|
Non-GAAP operating income (loss) |
$ |
277,804 |
|
|
$ |
(129,922 |
) |
|
$ |
13,915 |
|
|
$ |
(408,576 |
) |
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP net income (loss): |
|
|
|
|
|
|
|
||||||||
GAAP net income (loss) |
$ |
147,753 |
|
|
$ |
(405,920 |
) |
|
$ |
(302,372 |
) |
|
$ |
(923,663 |
) |
Add: Stock-based compensation expenses |
|
63,937 |
|
|
|
128,118 |
|
|
|
179,686 |
|
|
|
187,882 |
|
Add: Realized and unrealized loss on marketable equity securities |
|
16,844 |
|
|
|
7,850 |
|
|
|
17,711 |
|
|
|
40,108 |
|
Add: Loss on the extinguishment of debt |
|
— |
|
|
|
76,586 |
|
|
|
— |
|
|
|
76,586 |
|
Non-GAAP net income (loss) |
$ |
228,534 |
|
|
$ |
(193,366 |
) |
|
$ |
(104,975 |
) |
|
$ |
(619,087 |
) |
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP net income (loss) per common share- basic: |
|
|
|
|
|||||||||||
GAAP net income (loss) per common share - basic |
$ |
1.18 |
|
|
$ |
(3.32 |
) |
|
$ |
(2.43 |
) |
|
$ |
(7.62 |
) |
Add: Stock-based compensation expenses |
|
0.51 |
|
|
|
1.05 |
|
|
|
1.44 |
|
|
|
1.55 |
|
Add: Realized and unrealized loss on marketable equity securities |
|
0.13 |
|
|
|
0.06 |
|
|
|
0.14 |
|
|
|
0.33 |
|
Add: Loss on the extinguishment of debt |
|
— |
|
|
|
0.63 |
|
|
|
— |
|
|
|
0.63 |
|
Non-GAAP net income (loss) per common share - basic |
$ |
1.83 |
|
|
$ |
(1.58 |
) |
|
$ |
(0.84 |
) |
|
$ |
(5.11 |
) |
|
|
|
|
|
|
|
|
||||||||
Reconciliation of GAAP to Non-GAAP net income (loss) per common share- diluted: |
|
|
|
|
|||||||||||
GAAP net income (loss) per common share - diluted |
$ |
1.15 |
|
|
$ |
(3.32 |
) |
|
$ |
(2.43 |
) |
|
$ |
(7.62 |
) |
Add: Stock-based compensation expenses |
|
0.49 |
|
|
|
1.05 |
|
|
|
1.44 |
|
|
|
1.55 |
|
Add: Realized and unrealized loss on marketable equity securities |
|
0.13 |
|
|
|
0.06 |
|
|
|
0.14 |
|
|
|
0.33 |
|
Add: Loss on the extinguishment of debt |
|
— |
|
|
|
0.63 |
|
|
|
— |
|
|
|
0.63 |
|
Non-GAAP net income (loss) per common share - diluted |
$ |
1.74 |
|
|
$ |
(1.58 |
) |
|
$ |
(0.84 |
) |
|
$ |
(5.11 |
) |
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 Ended |
|
Nine Months Ended |
||
ONPATTRO net product revenue growth, as reported |
(44 |
)% |
|
(37 |
)% |
Add: Impact of foreign currency translation |
(2 |
) |
|
— |
|
ONPATTRO net product revenue growth at constant currency |
(46 |
)% |
|
(37 |
)% |
|
|
|
|
||
AMVUTTRA net product revenue growth, as reported |
489 |
% |
|
1416 |
% |
Add: Impact of foreign currency translation |
(1 |
) |
|
18 |
|
AMVUTTRA net product revenue growth at constant currency |
488 |
% |
|
1434 |
% |
|
|
|
|
||
Total TTR net product revenue growth, as reported |
35 |
% |
|
43 |
% |
Add: Impact of foreign currency translation |
(1 |
) |
|
1 |
|
Total TTR net product revenue growth at constant currency |
34 |
% |
|
44 |
% |
|
|
|
|
||
GIVLAARI net product revenue growth, as reported |
19 |
% |
|
27 |
% |
Add: Impact of foreign currency translation |
(2 |
) |
|
— |
|
GIVLAARI net product revenue growth at constant currency |
17 |
% |
|
27 |
% |
|
|
|
|
||
OXLUMO net product revenue growth, as reported |
75 |
% |
|
68 |
% |
Add: Impact of foreign currency translation |
(6 |
) |
|
(1 |
) |
OXLUMO net product revenue growth at constant currency |
69 |
% |
|
67 |
% |
|
|
|
|
||
Total net product revenue growth, as reported |
35 |
% |
|
41 |
% |
Add: Impact of foreign currency translation |
(2 |
) |
|
1 |
|
Total net product revenue growth at constant currency |
33 |
% |
|
42 |
% |
View source version on businesswire.com: https://www.businesswire.com/news/home/20231102700234/en/
(Investors and Media)
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(Investors)
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Source:
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