CAMBRIDGE, Mass. / Feb 23, 2023 / Business Wire / Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the fourth quarter and full year ended December 31, 2022 and reviewed recent business highlights.
“2022 was another year of strong progress at Alnylam, including our continued commercial execution which delivered 35% full-year product revenue growth (43% with constant exchange rate*) compared to 2021. A key factor in these results was the approval and launch of AMVUTTRA, which is off to a great start in its first two full quarters on the market. Further to our leadership in TTR amyloidosis, we’re thrilled to have submitted our sNDA for ONPATTRO for the treatment of the cardiomyopathy of ATTR amyloidosis, which has now been accepted by the FDA, and look forward to potentially bringing this important therapy to patients, if approved,” said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. “Looking ahead to 2023, we are excited for a number of important milestones across the pipeline, with 10 clinical readouts from proprietary and partner-led programs, including first-in-human results for an RNAi therapeutic in the CNS from our Phase 1 study of ALN-APP, as well as Phase 2 results from the KARDIA studies of zilebesiran. With the totality of this progress, we believe we are on track to achieve our Alnylam P5x25 goals and position Alnylam as a top-tier biotech company poised to deliver sustainable innovation.”
Fourth Quarter 2022 and Recent Significant Corporate Highlights
Commercial Performance
Total TTR: ONPATTRO® (patisiran) & AMVUTTRA® (vutrisiran)
GIVLAARI® (givosiran)
OXLUMO® (lumasiran)
Leqvio® (inclisiran)
R&D Highlights
Patisiran (the non-proprietary name for ONPATTRO), in development for the treatment of ATTR amyloidosis.
Vutrisiran (the non-proprietary name for AMVUTTRA), in development for the treatment of ATTR amyloidosis.
Lumasiran (the non-proprietary name for OXLUMO), for the treatment of primary hyperoxaluria type 1 (PH1).
Inclisiran (the non-proprietary name for Leqvio), for the treatment of hypercholesterolemia or mixed dyslipidemia, in collaboration with Novartis.
Early- and mid-stage investigational RNAi therapeutic pipeline programs and RNAi platform.
Additional Business Updates
Upcoming Events
In early 2023:
Financial Results for the Quarter and Year Ended December 31, 2022
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 December 31, 2021. CER is a Non-GAAP measure. |
Net Revenues from Collaborations
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
Selling, General & Administrative (SG&A) Expenses
Other Financial Highlights
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 December 31, 2023 financial guidance consists of the following:
Combined net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO1,2 | $1,200 million – $1,285 million |
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 | $100 million – $175 million |
GAAP R&D and SG&A expenses | $1,790 million – $1,885 million |
Non-GAAP R&D and SG&A expenses3 | $1,575 million – $1,650 million |
1 Uses December 31, 2022 Fx rates including: 1 EUR = 1.07 USD and 1 USD = 131 JPY 2 Assumes U.S. sNDA approval of patisiran for ATTR amyloidosis with cardiomyopathy by the PDUFA date on October 8, 2023 3 Excludes $215-$235 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, 2022. 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 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 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 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 Thursday, February 23, 2023 at 8:30 am ET. To access the call, please register online at https://register.vevent.com/register/BI050ad56309204f0a836ec037dd396473. Participants are requested to register at a minimum 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 the polyneuropathy of hATTR amyloidosis in adults. 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 the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. 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 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 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 20 years ago, 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 Twitter at @Alnylam, on LinkedIn, or on 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, expectations regarding Alnylam’s aspiration to become a leading biotech company and the planned achievement of its “Alnylam P5x25” strategy, 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 products, and Alnylam’s projected commercial and financial performance, 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: 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 and the effectiveness or timeliness of Alnylam’s efforts to mitigate the impact of the pandemic; 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 patisiran and vutrisiran; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, including patisiran and 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 indication for ONPATTRO or 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; Alnylam’s ability to maintain strategic business collaborations; Alnylam's dependence on third parties for the development and commercialization of certain products, including Novartis, Sanofi, Regeneron and Vir; the outcome of litigation; the potential impact of a current government investigation and the risk of future government investigations; and unexpected expenditures; as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam's 2022 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 its other SEC filings. 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. 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.
ALNYLAM PHARMACEUTICALS, INC. 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 |
|
ALNYLAM PHARMACEUTICALS, INC. 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: |
|
|
|
|
|
|
| ||||||||
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 | ) |
Non-GAAP Research and development | $ | 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 December 31, 2021 have been adjusted to reflect this updated presentation. |
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) | |||
| December 31, 2022 | ||
| 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% |
ALNYLAM PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except per share amounts) | |||||||
| December 31, |
| December 31, | ||||
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, $0.01 par value per share, 5,000 shares authorized and no shares issued and outstanding as of December 31, 2022 and December 31, 2021 |
| — |
|
|
| — |
|
Common stock, $0.01 par value per share, 250,000 shares authorized as of December 31, 2022 and December 31, 2021, respectively; 123,925 shares issued and outstanding as of December 31, 2022; 120,182 shares issued and outstanding as of December 31, 2021 |
| 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 December 31, 2021.
Last Trade: | US$246.78 |
Daily Change: | -4.70 -1.87 |
Daily Volume: | 669,840 |
Market Cap: | US$31.680B |
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