Alnylam Pharmaceuticals Reports Third Quarter 2024 Financial Results and Highlights Recent Period Activity
Alnylam Pharmaceuticals (ALNY) reported strong Q3 2024 financial results with global net product revenues of $420 million, representing 34% year-over-year growth. The growth was primarily driven by their TTR business, with AMVUTTRA generating $259 million and ONPATTRO $50 million in revenues. The company submitted regulatory applications in U.S. and EU for AMVUTTRA for ATTR-CM treatment. Cash position stood at $2.78 billion as of September 30, 2024. The company reiterated its 2024 financial guidance, expecting combined net product revenues of $1,575-$1,650 million.
Alnylam Pharmaceuticals (ALNY) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con entrate globali nette da prodotto di 420 milioni di dollari, corrispondenti a una crescita del 34% rispetto all'anno precedente. La crescita è stata principalmente alimentata dal loro business TTR, con AMVUTTRA che ha generato 259 milioni di dollari e ONPATTRO 50 milioni di dollari in entrate. L'azienda ha presentato domande normative negli Stati Uniti e nell'UE per AMVUTTRA per il trattamento dell'ATTR-CM. La posizione di cassa si è attestata a 2,78 miliardi di dollari al 30 settembre 2024. L'azienda ha ribadito le sue previsioni finanziarie per il 2024, prevedendo entrate nette combinate da prodotto di 1.575-1.650 milioni di dollari.
Alnylam Pharmaceuticals (ALNY) reportó resultados financieros sólidos para el tercer trimestre de 2024, con ingresos netos globales de productos de 420 millones de dólares, lo que representa un crecimiento del 34% en comparación con el año anterior. El crecimiento fue impulsado principalmente por su negocio de TTR, con AMVUTTRA generando 259 millones de dólares y ONPATTRO 50 millones de dólares en ingresos. La compañía presentó solicitudes regulatorias en EE.UU. y la UE para AMVUTTRA para el tratamiento del ATTR-CM. La posición de efectivo se situó en 2,78 mil millones de dólares al 30 de septiembre de 2024. La empresa reiteró su guía financiera para 2024, esperando ingresos netos combinados de productos de 1.575 a 1.650 millones de dólares.
Alnylam Pharmaceuticals (ALNY)는 2024년 3분기 강력한 재무 결과를 보고했으며, 전세계 순 제품 수익이 4억 2천만 달러로 전년 대비 34% 성장했습니다. 성장은 주로 TTR 비즈니스에 의해 주도되었으며, AMVUTTRA가 2억 5,900만 달러, ONPATTRO가 5천만 달러의 수익을 올렸습니다. 회사는 ATTR-CM 치료를 위한 AMVUTTRA에 대해 미국과 EU에 규제 신청서를 제출했습니다. 현금 보유량은 2024년 9월 30일 현재 27억 8천만 달러에 달합니다. 회사는 2024년 재무 전망을 반복하여 순 제품 수익이 1,575억에서 1,650억 달러에 이를 것으로 예상하고 있습니다.
Alnylam Pharmaceuticals (ALNY) a annoncé de solides résultats financiers pour le troisième trimestre de 2024, avec des revenus nets globaux de produits de 420 millions de dollars, représentant une croissance de 34 % par rapport à l'année précédente. Cette croissance a été principalement tirée par leur activité TTR, AMVUTTRA générant 259 millions de dollars et ONPATTRO 50 millions de dollars de revenus. L'entreprise a soumis des demandes réglementaires aux États-Unis et dans l'UE pour AMVUTTRA pour le traitement de l'ATTR-CM. La position de trésorerie s'élevait à 2,78 milliards de dollars au 30 septembre 2024. L'entreprise a réitéré ses prévisions financières pour 2024, s'attendant à des revenus nets combinés de produits de 1,575 à 1,650 millions de dollars.
Alnylam Pharmaceuticals (ALNY) hat für das dritte Quartal 2024 ein starkes finanzielles Ergebnis berichtet, mit globalen Netto-Produktumsätzen von 420 Millionen Dollar, was einer Wachstumsrate von 34% im Vergleich zum Vorjahr entspricht. Das Wachstum wurde hauptsächlich durch ihr TTR-Geschäft vorangetrieben, wobei AMVUTTRA 259 Millionen Dollar und ONPATTRO 50 Millionen Dollar an Umsatz generierte. Das Unternehmen hat regulatorische Anträge in den USA und der EU für AMVUTTRA zur Behandlung von ATTR-CM eingereicht. Die Barmittelposition betrug zum Stand vom 30. September 2024 2,78 Milliarden Dollar. Das Unternehmen bestätigte seine finanzielle Prognose für 2024 und erwartet kombinierte Netto-Produktumsätze von 1.575 bis 1.650 Millionen Dollar.
- 34% YoY growth in global net product revenues to $420M
- AMVUTTRA revenue grew 74% YoY to $259M
- Strong cash position of $2.78B, up from $2.44B in December 2023
- Maintained positive 2024 guidance with 27-33% revenue growth
- GAAP Operating loss of $76.9M vs income of $213.9M in Q3 2023
- Net loss of $111.6M vs net income of $147.8M in Q3 2023
- ONPATTRO revenue declined 38% YoY to $50.3M
- Suspended clinical development of ALN-KHK for type 2 diabetes
Insights
A strong quarter for Alnylam with
Key financial metrics reveal some concerns: GAAP operating loss of
Significant pipeline progress with multiple therapeutic programs. The vutrisiran ATTR-CM regulatory submissions in both US and EU positions the company for potential market expansion in early 2025. The mivelsiran Alzheimer's disease program shows promise with
The strategic decision to suspend ALN-KHK development for type 2 diabetes demonstrates disciplined portfolio management. The advancement of ALN-HTT02 for Huntington's disease and planned Phase 2 study for mivelsiran in Alzheimer's disease indicate strong pipeline momentum in neurodegenerative diseases.
− Achieved Third Quarter 2024 Global Net Product Revenues of
− Submitted Regulatory Applications in
− Reiterated 2024 Financial Guidance, Including Combined Net Product Revenues of
“Alnylam continued to deliver robust results commercially and clinically in the third quarter. We achieved
Third Quarter 2024 and Recent Significant Business Highlights
Commercial Performance
Total TTR: ONPATTRO® (patisiran) & AMVUTTRA® (vutrisiran)
-
Continued growth momentum in total TTR, achieving global net product revenues for ONPATTRO and AMVUTTRA for the third quarter of
$50 million $259 million 34% TTR annual growth compared to Q3 2023.
Total Rare: GIVLAARI® (givosiran) & OXLUMO® (lumasiran)
-
Achieved global net product revenues for GIVLAARI and OXLUMO for the third quarter of
$71 million $40 million 34% Rare annual growth compared to Q3 2023.
R&D Highlights
-
Presented detailed results from the positive HELIOS-B Phase 3 study of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM) at the European Society of Cardiology Congress (ESC).
- Additional data from HELIOS-B, including echocardiographic and biomarker data, were presented at the Heart Failure Society of America Annual Scientific Meeting 2024 (HFSA).
-
Based on these positive results, Alnylam submitted a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) using a Priority Review Voucher, as well as a Type II Variation to the European Medicines Agency (EMA), for vutrisiran for the treatment of ATTR amyloidosis with cardiomyopathy.
-
Today announced positive initial results from the multiple dose portion of the Phase 1 study of mivelsiran in patients with Alzheimer’s disease.
-
Following a second 50 mg dose of mivelsiran at month 6, further reductions of sAPPβ were observed at month 7, with patients achieving greater than
90% lowering of sAPPβ. - No new safety signals have been identified, and no significant abnormalities have been seen on CSF safety labs such as total protein and CSF white cell count, or on the exploratory biomarker neurofilament light chain.
-
Following a second 50 mg dose of mivelsiran at month 6, further reductions of sAPPβ were observed at month 7, with patients achieving greater than
- Presented the design of the cAPPricorn-1 Phase 2 study of mivelsiran in patients with cerebral amyloid angiopathy (CAA) at the 2024 International CAA Conference.
-
Initiated a Phase 1 study of ALN-HTT02 in adult patients with Huntington’s disease.
- Exon1 targeting strategy and design of the Phase 1 study were presented at the European Huntington's Disease Network (EHDN) & Enroll-HD 2024 Congress.
- Nonclinical data supporting the tolerability of deep and sustained HTT-lowering in wild-type nonhuman primates after single and repeated intrathecal administration of ALN-HTT02 were also shared.
- Today announced the decision to suspend further clinical development of ALN-KHK, an investigational RNAi therapeutic targeting ketohexokinase for the treatment of type 2 diabetes mellitus. This decision reflects portfolio prioritization efforts to allocate clinical, managerial and financial resources carefully to bring transformative medicines to patients.
Additional Business Updates
- Alnylam hosted a TTR Investor Day featuring presentations from Alnylam senior leaders and an external expert related to the Company's TTR business. A replay of the webcast is available on the Company's website.
- Appointed Robert Hesslein as Chief Legal Officer and Corporate Secretary.
- Named one of Fast Company Top 100 Workplaces for Innovators in 2024.
- Recognized by Science magazine as a Top Employer for the sixth consecutive year.
Upcoming Events
Alnylam will present additional findings from the ongoing Phase 1 study of ALN-TTRsc04 in patients with ATTR amyloidosis at the American Heart Association Scientific Sessions 2024. The Company plans to share its Phase 3 development plan for ALN-TTRsc04 in the first quarter of 2025.
Alnylam intends to initiate a Phase 2 study of mivelsiran in patients with Alzheimer’s disease at or around year-end.
Financial Results for the Quarter Ended September 30, 2024
|
Three Months Ended
|
|||||
(In thousands, except per share amounts) |
|
2024 |
|
|
2023 |
|
Net product revenues |
$ |
420,146 |
|
|
$ |
313,153 |
Net revenue from collaborations |
$ |
57,387 |
|
|
$ |
427,472 |
Royalty revenue |
$ |
23,386 |
|
|
$ |
9,905 |
|
|
|
|
|||
GAAP Operating (loss) income |
$ |
(76,905 |
) |
|
$ |
213,867 |
Non-GAAP Operating (loss) income |
$ |
(31,101 |
) |
|
$ |
277,804 |
|
|
|
|
|||
GAAP Net (loss) income |
$ |
(111,570 |
) |
|
$ |
147,753 |
Non-GAAP Net (loss) income |
$ |
(64,199 |
) |
|
$ |
228,534 |
|
|
|
|
|||
GAAP Net (loss) income per common share - basic |
$ |
(0.87 |
) |
|
$ |
1.18 |
Non-GAAP Net (loss) income per common share - basic |
$ |
(0.50 |
) |
|
$ |
1.83 |
|
|
|
|
|||
GAAP Net (loss) income per common share - diluted |
$ |
(0.87 |
) |
|
$ |
1.15 |
Non-GAAP Net (loss) income per common share - diluted |
$ |
(0.50 |
) |
|
$ |
1.74 |
|
|
|
|
|||
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 measure, see the tables at the end of this press release. |
||||||
Net Product Revenues
|
Three Months Ended September 30, |
|
Year over Year % Growth |
||||||
(In thousands, except percentages) |
2024 |
|
2023 |
|
As Reported |
|
At CER* |
||
ONPATTRO net product revenues |
$ |
50,293 |
|
$ |
81,589 |
|
(38)% |
|
(38)% |
AMVUTTRA net product revenues |
|
258,590 |
|
|
148,680 |
|
|
|
|
Total TTR net product revenues |
|
308,883 |
|
|
230,269 |
|
|
|
|
|
|
|
|
|
|
|
|
||
GIVLAARI net product revenues |
|
71,043 |
|
|
54,148 |
|
|
|
|
OXLUMO net product revenues |
|
40,220 |
|
|
28,736 |
|
|
|
|
Total Rare net product revenues |
|
111,263 |
|
|
82,884 |
|
|
|
|
|
|
|
|
|
|
|
|
||
Total net product revenues |
$ |
420,146 |
|
$ |
313,153 |
|
|
|
|
|
|
|
|
|
|
|
|
||
* CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the third quarter 2023. CER is a non-GAAP measure. |
|||||||||
-
Total net product revenues increased
34% and35% at actual currency and CER, respectively, during the three months ended September 30, 2024, as compared to the same period in 2023, due to an increased number of patients receiving AMVUTTRA, GIVLAARI, and OXLUMO, partially offset by a decrease in patients receiving ONPATTRO primarily driven by switching to AMVUTTRA.
Net Revenues from Collaborations
-
Net revenues from collaborations decreased during the three months ended September 30, 2024, as compared to the same period in 2023, due to less revenue recognized under our collaborations with Roche and Regeneron. During 2023, we recognized
$310 million $65 million $100 million
Operating Expenses
|
Three Months Ended
|
||||||
(In thousands, except percentages) |
|
2024 |
|
|
|
2023 |
|
Cost of goods sold |
$ |
81,980 |
|
|
$ |
79,473 |
|
Cost of goods sold as a percentage of net product revenues |
|
19.5 |
% |
|
|
25.4 |
% |
|
|
|
|
||||
Cost of collaborations and royalties |
$ |
3,925 |
|
|
$ |
4,836 |
|
|
|
|
|
||||
GAAP research and development expenses |
$ |
270,926 |
|
|
$ |
253,179 |
|
Non-GAAP research and development expenses |
$ |
251,132 |
|
|
$ |
224,024 |
|
|
|
|
|
||||
GAAP selling, general and administrative expenses |
$ |
220,993 |
|
|
$ |
199,175 |
|
Non-GAAP selling, general and administrative expenses |
$ |
194,983 |
|
|
$ |
164,393 |
|
Cost of Goods Sold
-
Cost of goods sold as a percentage of net product revenues decreased during the three months ended September 30, 2024, as compared to the same period in 2023, primarily due to higher costs in 2023 associated with cancelled manufacturing commitments and the impairment of ONPATTRO inventory that had been manufactured for future demand associated with the use of patisiran for the treatment of patients with ATTR amyloidosis with cardiomyopathy for which we did not receive regulatory approval in the
U.S. , offset by increased rate of royalties payable on net sales of AMVUTTRA.
Research & Development (R&D) Expenses
- GAAP and non-GAAP R&D expenses increased during the three months ended September 30, 2024, as compared to the same period in 2023, primarily due to increased costs associated with our preclinical activities as we develop our clinical pipeline of RNAi therapeutics targeting multiple tissues, increased clinical trial expenses associated with increased Phase 2 activities for the zilebesiran KARDIA-3 clinical trial, and increased employee compensation expenses.
Selling, General & Administrative (SG&A) Expenses
- GAAP and non-GAAP SG&A expenses increased during the three months ended September 30, 2024, as compared to the same period in 2023, primarily due to higher costs associated with marketing investments to promote our TTR therapies and prepare for the potential launch of AMVUTTRA for the treatment of ATTR amyloidosis with cardiomyopathy, and employee compensation.
Other Financial Highlights
-
Cash, cash equivalents and marketable securities were
$2.78 billion $2.44 billion
A reconciliation of our GAAP to non-GAAP financial results for the quarter is included in the tables at the end of this press release.
2024 Financial Guidance
Full year 2024 financial guidance is reiterated and consists of the following:
Combined net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO1 |
|
|
Net Product Revenue Growth vs. 2023 at reported FX rates1 |
|
|
Net Product Revenue Growth vs. 2023 at CER* |
|
|
Net revenues from collaborations and royalties |
|
|
GAAP R&D and SG&A expenses |
|
|
Non-GAAP R&D and SG&A expenses2 |
|
|
|
|
|
1 Uses June 30, 2024 FX rates including: |
||
2 Primarily excludes |
||
*CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in the twelve months ended December 31, 2023. CER is a non-GAAP measure. |
||
Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses and non-recurring gains outside the ordinary course of the Company’s business. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.
The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are stock-based compensation expenses and realized and unrealized losses on marketable equity securities. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of the realized and unrealized losses on marketable equity securities because the Company does not believe these adjustments accurately reflect the performance of the Company’s ongoing operations for the period in which such gains or losses are reported, as their sole purpose is to adjust amounts on the balance sheet.
Percentage changes in revenue growth at CER are presented excluding the impact of changes in foreign currency exchange rates for investors to understand the underlying business performance. The current period’s foreign currency revenue values are converted into
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 third quarter 2024 results as well as expectations for the future via conference call on Thursday, October 31, 2024 at 8:30 am ET. 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
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
Alnylam has licenses to Arbutus Biopharma lipid nanoparticle (LNP) intellectual property for use in RNAi therapeutic products using LNP technology.
About RNAi
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.
About Alnylam Pharmaceuticals
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding in 2002, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality. Alnylam’s commercial RNAi therapeutic products are ONPATTRO® (patisiran), AMVUTTRA® (vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and Leqvio® (inclisiran), which is being developed and commercialized by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of investigational medicines, including multiple product candidates that are in late-stage development. Alnylam is executing on its “Alnylam P5x25” strategy to deliver transformative medicines in both rare and common diseases benefiting patients around the world through sustainable innovation and exceptional financial performance, resulting in a leading biotech profile. Alnylam is headquartered in
Alnylam Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, statements regarding Alnylam’s expectations regarding the potential launch of AMVUTTRA for the treatment of ATTR amyloidosis with cardiomyopathy 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. Vutrisiran 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.
|
|||||||
|
September 30,
|
|
December 31,
|
||||
ASSETS |
(Unaudited) |
|
|
||||
Current assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
1,099,920 |
|
|
$ |
812,688 |
|
Marketable debt securities |
|
1,671,993 |
|
|
|
1,615,516 |
|
Marketable equity securities |
|
8,322 |
|
|
|
11,178 |
|
Accounts receivable, net |
|
353,852 |
|
|
|
327,787 |
|
Inventory |
|
75,987 |
|
|
|
89,146 |
|
Prepaid expenses and other current assets |
|
145,350 |
|
|
|
126,382 |
|
Total current assets |
|
3,355,424 |
|
|
|
2,982,697 |
|
Property, plant and equipment, net |
|
506,997 |
|
|
|
526,057 |
|
Operating lease right-of-use assets |
|
196,408 |
|
|
|
199,732 |
|
Restricted investments |
|
68,592 |
|
|
|
49,391 |
|
Other assets |
|
77,618 |
|
|
|
72,003 |
|
Total assets |
$ |
4,205,039 |
|
|
$ |
3,829,880 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
||||
Current liabilities: |
|
|
|
||||
Accounts payable |
$ |
70,805 |
|
|
$ |
55,519 |
|
Accrued expenses |
|
946,168 |
|
|
|
713,013 |
|
Operating lease liability |
|
42,144 |
|
|
|
41,510 |
|
Deferred revenue |
|
71,030 |
|
|
|
102,753 |
|
Liability related to the sale of future royalties |
|
90,516 |
|
|
|
54,991 |
|
Total current liabilities |
|
1,220,663 |
|
|
|
967,786 |
|
Operating lease liability, net of current portion |
|
236,030 |
|
|
|
243,101 |
|
Deferred revenue, net of current portion |
|
1,012 |
|
|
|
188,175 |
|
Convertible debt |
|
1,023,654 |
|
|
|
1,020,776 |
|
Liability related to the sale of future royalties, net of current portion |
|
1,333,849 |
|
|
|
1,322,248 |
|
Other liabilities |
|
357,477 |
|
|
|
308,438 |
|
Total liabilities |
|
4,172,685 |
|
|
|
4,050,524 |
|
Commitments and contingencies (Note 13) |
|
|
|
||||
Stockholders’ equity (deficit): |
|
|
|
||||
Preferred stock, |
|
— |
|
|
|
— |
|
Common stock, |
|
1,289 |
|
|
|
1,259 |
|
Additional paid-in capital |
|
7,259,876 |
|
|
|
6,811,063 |
|
Accumulated other comprehensive loss |
|
(24,826 |
) |
|
|
(23,375 |
) |
Accumulated deficit |
|
(7,203,985 |
) |
|
|
(7,009,591 |
) |
Total stockholders’ equity (deficit) |
|
32,354 |
|
|
|
(220,644 |
) |
Total liabilities and stockholders’ equity (deficit) |
$ |
4,205,039 |
|
|
$ |
3,829,880 |
|
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alnylam’s Annual Report on Form 10-K which includes the audited financial statements for the year ended December 31, 2023.
ALNYLAM PHARMACEUTICALS, INC.
|
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|
Three Months Ended |
|
Nine Months Ended |
||||||||||||
|
September 30,
|
|
September 30,
|
|
September 30,
|
|
September 30,
|
||||||||
Statements of Operations |
|
|
|
|
|
|
|
||||||||
Revenues: |
|
|
|
|
|
|
|
||||||||
Net product revenues |
$ |
420,146 |
|
|
$ |
313,153 |
|
|
$ |
1,195,397 |
|
|
$ |
895,186 |
|
Net revenues from collaborations |
|
57,387 |
|
|
|
427,472 |
|
|
|
403,273 |
|
|
|
469,778 |
|
Royalty revenue |
|
23,386 |
|
|
|
9,905 |
|
|
|
56,407 |
|
|
|
23,610 |
|
Total revenues |
|
500,919 |
|
|
|
750,530 |
|
|
|
1,655,077 |
|
|
|
1,388,574 |
|
|
|
|
|
|
|
|
|
||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
||||||||
Cost of goods sold |
|
81,980 |
|
|
|
79,473 |
|
|
|
203,864 |
|
|
|
196,241 |
|
Cost of collaborations and royalties |
|
3,925 |
|
|
|
4,836 |
|
|
|
16,689 |
|
|
|
28,307 |
|
Research and development |
|
270,926 |
|
|
|
253,179 |
|
|
|
826,063 |
|
|
|
732,274 |
|
Selling, general and administrative |
|
220,993 |
|
|
|
199,175 |
|
|
|
680,187 |
|
|
|
597,523 |
|
Total operating costs and expenses |
|
577,824 |
|
|
|
536,663 |
|
|
|
1,726,803 |
|
|
|
1,554,345 |
|
(Loss) income from operations |
|
(76,905 |
) |
|
|
213,867 |
|
|
|
(71,726 |
) |
|
|
(165,771 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
||||||||
Interest expense |
|
(34,376 |
) |
|
|
(30,893 |
) |
|
|
(102,887 |
) |
|
|
(89,883 |
) |
Interest income |
|
32,146 |
|
|
|
25,425 |
|
|
|
90,973 |
|
|
|
65,155 |
|
Other expense, net |
|
(29,528 |
) |
|
|
(57,658 |
) |
|
|
(99,777 |
) |
|
|
(105,331 |
) |
Total other expense, net |
|
(31,758 |
) |
|
|
(63,126 |
) |
|
|
(111,691 |
) |
|
|
(130,059 |
) |
(Loss) income before income taxes |
|
(108,663 |
) |
|
|
150,741 |
|
|
|
(183,417 |
) |
|
|
(295,830 |
) |
Provision for income taxes |
|
(2,907 |
) |
|
|
(2,988 |
) |
|
|
(10,977 |
) |
|
|
(6,542 |
) |
Net (loss) income |
$ |
(111,570 |
) |
|
$ |
147,753 |
|
|
$ |
(194,394 |
) |
|
$ |
(302,372 |
) |
|
|
|
|
|
|
|
|
||||||||
Net (loss) income per common share - basic |
$ |
(0.87 |
) |
|
$ |
1.18 |
|
|
$ |
(1.53 |
) |
|
$ |
(2.43 |
) |
Net (loss) income per common share - diluted |
$ |
(0.87 |
) |
|
$ |
1.15 |
|
|
$ |
(1.53 |
) |
|
$ |
(2.43 |
) |
|
|
|
|
|
|
|
|
||||||||
Weighted-average common shares - basic |
|
128,590 |
|
|
|
125,220 |
|
|
|
127,159 |
|
|
|
124,667 |
|
Weighted-average common shares - diluted |
|
128,590 |
|
|
|
131,337 |
|
|
|
127,159 |
|
|
|
124,667 |
|
ALNYLAM PHARMACEUTICALS, INC.
|
|||||||
|
Three Months Ended |
||||||
|
September 30,
|
|
September 30,
|
||||
Reconciliation of GAAP to Non-GAAP Research and development: |
|
|
|
||||
GAAP Research and development |
$ |
270,926 |
|
|
$ |
253,179 |
|
Less: Stock-based compensation expenses |
|
(19,794 |
) |
|
|
(29,155 |
) |
Non-GAAP Research and development |
$ |
251,132 |
|
|
$ |
224,024 |
|
|
|
|
|
||||
Reconciliation of GAAP to Non-GAAP Selling, general and administrative: |
|
|
|
||||
GAAP Selling, general and administrative |
$ |
220,993 |
|
|
$ |
199,175 |
|
Less: Stock-based compensation expenses |
|
(26,010 |
) |
|
|
(34,782 |
) |
Non-GAAP Selling, general and administrative |
$ |
194,983 |
|
|
$ |
164,393 |
|
|
|
|
|
||||
Reconciliation of GAAP to Non-GAAP Operating (loss) income: |
|||||||
GAAP Operating (loss) income |
$ |
(76,905 |
) |
|
$ |
213,867 |
|
Add: Stock-based compensation expenses |
|
45,804 |
|
|
|
63,937 |
|
Non-GAAP Operating (loss) income |
$ |
(31,101 |
) |
|
$ |
277,804 |
|
|
|
|
|
||||
Reconciliation of GAAP to Non-GAAP Net (loss) income: |
|
|
|
||||
GAAP Net (loss) income |
$ |
(111,570 |
) |
|
$ |
147,753 |
|
Add: Stock-based compensation expenses |
|
45,804 |
|
|
|
63,937 |
|
Add: Realized and unrealized loss on marketable equity securities |
|
1,567 |
|
|
|
16,844 |
|
Non-GAAP Net (loss) income |
$ |
(64,199 |
) |
|
$ |
228,534 |
|
|
|
|
|
||||
Reconciliation of GAAP to Non-GAAP Net (loss) income per common share- basic: |
|||||||
GAAP Net (loss) income per common share - basic |
$ |
(0.87 |
) |
|
$ |
1.18 |
|
Add: Stock-based compensation expenses |
|
0.36 |
|
|
|
0.51 |
|
Add: Realized and unrealized loss on marketable equity securities |
|
0.01 |
|
|
|
0.13 |
|
Non-GAAP Net (loss) income per common share - basic |
$ |
(0.50 |
) |
|
$ |
1.83 |
|
|
|
|
|
||||
Reconciliation of GAAP to Non-GAAP Net (loss) income per common share- diluted: |
|||||||
GAAP Net (loss) income per common share - diluted |
$ |
(0.87 |
) |
|
$ |
1.15 |
|
Add: Stock-based compensation expenses |
|
0.36 |
|
|
|
0.49 |
|
Add: Realized and unrealized loss on marketable equity securities |
|
0.01 |
|
|
|
0.13 |
|
Non-GAAP Net (loss) income per common share - diluted |
$ |
(0.50 |
) |
|
$ |
1.74 |
|
Please note that the figures presented above may not sum exactly due to rounding
ALNYLAM PHARMACEUTICALS, INC.
|
||
|
September 30, 2024 |
|
|
Three Months Ended |
|
ONPATTRO net product revenue growth, as reported |
(38 |
)% |
Add: Impact of foreign currency translation |
— |
|
ONPATTRO net product revenue growth at constant currency |
(38 |
)% |
|
|
|
AMVUTTRA net product revenue growth, as reported |
74 |
% |
Add: Impact of foreign currency translation |
1 |
|
AMVUTTRA net product revenue growth at constant currency |
75 |
% |
|
|
|
Total TTR net product revenue growth, as reported |
34 |
% |
Add: Impact of foreign currency translation |
1 |
|
Total TTR net product revenue growth at constant currency |
35 |
% |
|
|
|
GIVLAARI net product revenue growth, as reported |
31 |
% |
Add: Impact of foreign currency translation |
— |
|
GIVLAARI net product revenue growth at constant currency |
31 |
% |
|
|
|
OXLUMO net product revenue growth, as reported |
40 |
% |
Add: Impact of foreign currency translation |
— |
|
OXLUMO net product revenue growth at constant currency |
40 |
% |
|
|
|
Total net product revenue growth, as reported |
34 |
% |
Add: Impact of foreign currency translation |
1 |
|
Total net product revenue growth at constant currency |
35 |
% |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031367620/en/
Alnylam Pharmaceuticals, Inc.
Christine Regan Lindenboom
(Investors and Media)
617-682-4340
Josh Brodsky
(Investors)
617-551-8276
Source: Alnylam Pharmaceuticals, Inc.
FAQ
What was Alnylam's (ALNY) revenue growth in Q3 2024?
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What is Alnylam's (ALNY) 2024 revenue guidance?
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