0001157523-24-000253.txt : 20240215 0001157523-24-000253.hdr.sgml : 20240215 20240215081027 ACCESSION NUMBER: 0001157523-24-000253 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240215 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240215 DATE AS OF CHANGE: 20240215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALNYLAM PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001178670 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 770602661 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36407 FILM NUMBER: 24642207 BUSINESS ADDRESS: STREET 1: 675 WEST KENDALL STREET STREET 2: HENRI A. TERMEER SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02142 BUSINESS PHONE: (617) 551-8200 MAIL ADDRESS: STREET 1: 675 WEST KENDALL STREET STREET 2: HENRI A. TERMEER SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02142 FORMER COMPANY: FORMER CONFORMED NAME: ALNYLAM PHARMACEUTICALS INC DATE OF NAME CHANGE: 20020724 8-K 1 a53896787.htm ALNYLAM PHARMACEUTICALS, INC. 8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  February 15, 2024
 
Alnylam Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)


Delaware
001-36407
77-0602661
(State or Other Juris-
diction of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)


675 West Kendall Street,
Henri A. Termeer Square
Cambridge, Massachusetts
02142
(Address of Principal Executive Offices)
(Zip Code)

Registrant’s telephone number, including area code:  (617) 551-8200
 
Not applicable
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
☐  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class
   Trading Symbol(s)
  
Name of Each Exchange on Which Registered
Common Stock, $0.01 par value per share
   ALNY
   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company     ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐

Item 2.02.
Results of Operations and Financial Condition
                                    
On February 15, 2024, Alnylam Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter and year ended December 31, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.  
Financial Statements and Exhibits
                                    
     (d)     Exhibits

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

 
 99.1 Press Release dated February 15, 2024.
     
  104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURE

          Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 
 ALNYLAM PHARMACEUTICALS, INC.
 
 
 
Date: February 15, 2024 By:
 /s/    Jeffrey V. Poulton
 
 
 Jeffrey V. Poulton
 
 
Executive Vice President, Chief Financial Officer

EX-99.1 2 a53896787ex99_1.htm EXHIBIT 99.1
Exhibit 99.1

Alnylam Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Period Activity

− Achieved Fourth Quarter and Full Year 2023 Global Net Product Revenues of $346 Million and $1,241 Million, Respectively, Representing 39% Annual Growth Compared to 2022 –

− Company Announces Updated Statistical Analysis Plan and Timing for HELIOS-B Phase 3 Study of Vutrisiran –

− Announces U.S. FDA Clearance to Initiate Multiple-Dosing in ALN-APP Phase 1 Study –

− Provides 2024 Combined Net Product Revenue Guidance of $1,400 Million to $1,500 Million, in Addition to Collaboration and Royalty Revenue and Operating Expense Guidance –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 15, 2024--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, 2023 and reviewed recent business highlights.

“2023 was a year of strong execution at Alnylam. We delivered robust product revenue growth across our four wholly-owned commercial medicines, with $1.24 billion in global net product revenues, and achieved over 5,000 patients now being treated with an Alnylam commercial medicine. We also extended our leadership in RNAi with the first clinical demonstration of gene silencing in the human brain using an RNAi therapeutic, strengthened our business for the future through a landmark partnership with Roche and delivered solid financial performance,” said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. “Looking ahead to 2024, we are excited for a number of important milestones across the pipeline, including results from the HELIOS-B Phase 3 study of vutrisiran as well as the KARDIA-2 Phase 2 study of zilebesiran, and six clinical study starts. This progress sets us up for delivering on our Alnylam P5x25 goals of becoming a top-tier biotech company delivering sustained innovation and exceptional financial results.”

Fourth 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 fourth quarter of $79 million and $175 million, respectively, representing 10% total TTR quarterly growth compared to Q3 2023, and full year 2023 revenues of $355 million and $558 million, respectively, representing 40% total TTR annual growth compared to full year 2022.
  • Attained over 4,060 hATTR amyloidosis patients with polyneuropathy worldwide on commercial treatment with ONPATTRO or AMVUTTRA as of December 31, 2023.

Total Ultra-Rare: GIVLAARI® (givosiran) & OXLUMO® (lumasiran)

  • Achieved global net product revenues for GIVLAARI and OXLUMO for the fourth quarter of $59 million and $33 million, respectively, representing 11% total Ultra-Rare quarterly growth compared to Q3 2023, and full year 2023 revenues of $219 million and $110 million, respectively, representing 35% total Ultra-Rare annual growth compared to full year 2022.
  • Attained over 650 patients on commercial GIVLAARI and over 430 patients on commercial OXLUMO worldwide as of December 31, 2023.

R&D Highlights

Alnylam announces today updates to the statistical analysis plan for the HELIOS-B Phase 3 study of vutrisiran in patients with ATTR amyloidosis with cardiomyopathy. These will include updates to the primary and secondary endpoint structure, as well as study exposure. Topline results are expected to be available in late June or early July. Details will be discussed on the conference call this morning.

Published results from Phase 3 APOLLO-B study of patisiran in the New England Journal of Medicine.

Presented positive initial Phase 1 results with ALN-TTRsc04 demonstrating rapid knockdown achieved by a single dose with mean serum TTR reduction up to 97%, with durability supporting potential for annual dosing and an encouraging safety profile.

Presented positive results from the KARDIA-1 Phase 2 dose-ranging study of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension patients at high cardiovascular risk, during the American Heart Association (AHA) Scientific Sessions.

Announces today that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate the multiple-dose part (Part B) of the ongoing Phase 1 study of ALN-APP, an investigational RNAi therapeutic targeting amyloid precursor protein (APP) in development for the treatment of Alzheimer’s disease and cerebral amyloid angiopathy. The FDA has confirmed that multiple-dosing in the Phase 1 study may proceed at doses up to 180 mg given every six months, which covers all dose regimens planned to be explored in Part B. A partial clinical hold remains for higher or more frequent dosing regimens.

  • 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 Association International Conference and at the 16th Clinical Trials in Alzheimer’s Disease conference.

Presented positive initial Phase 1 results with ALN-KHK demonstrating robust target engagement and an encouraging safety profile, supporting continued development as a novel treatment for type 2 diabetes mellitus.

Filed an Investigational New Drug (IND) application for ALN-BCAT, an investigational RNAi therapeutic targeting β-catenin in development for the treatment of hepatocellular carcinoma.

Sanofi presented positive results from the ATLAS-OLE Phase 3 extension study of fitusiran, demonstrating a substantially improved safety profile and consistent bleed protection in people with hemophilia A or B, with or without inhibitors. Specifically, the risk of thrombosis was reduced, with rates comparable to those reported in the general hemophilia population.

  • Sanofi expects to submit a New Drug Application (NDA) to the FDA in 2024.

Additional Business Updates

  • Ranked #1 on Boston Globe’s Top Places to Work list for 2023 in the “Largest Employer” category.
  • Recognized by Science magazine as a Top Employer for the fifth consecutive year.

Upcoming Events

Alnylam announces today that results from the KARDIA-2 Phase 2 study of zilebesiran will be presented in a Late-Breaker presentation at the American College of Cardiology Scientific Sessions 2024 on April 7, 2024 in Atlanta, Georgia.

In early 2024, Alnylam intends to:

  • Report topline results from the HELIOS-B Phase 3 study of vutrisiran in late June or early July.
  • Initiate the KARDIA-3 Phase 2 study of zilebesiran.
  • Initiate a Phase 2 study of ALN-APP in patients with cerebral amyloid angiopathy.
  • Initiate Part B of the Phase 1 study of ALN-KHK.
  • Initiate a Phase 1 study of ALN-BCAT.

Financial Highlights for the Fourth Quarter and Year End 2023

 

Three Months Ended
December 31,

 

Twelve Months Ended
December 31,

(In thousands, except per share amounts)

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Net product revenues

$

346,288

 

 

$

261,675

 

 

$

1,241,474

 

 

$

894,329

 

Net revenue from collaborations

$

76,407

 

 

$

70,645

 

 

$

546,185

 

 

$

134,912

 

Royalty revenue

$

17,023

 

 

$

2,715

 

 

$

40,633

 

 

$

8,177

 

 

 

 

 

 

 

 

 

GAAP Operating loss

$

(116,404

)

 

$

(188,614

)

 

$

(282,175

)

 

$

(785,072

)

Non-GAAP Operating loss

$

(74,410

)

 

$

(145,847

)

 

$

(60,495

)

 

$

(554,423

)

 

 

 

 

 

 

 

 

GAAP Net loss

$

(137,870

)

 

$

(207,493

)

 

$

(440,242

)

 

$

(1,131,156

)

Non-GAAP Net loss

$

(96,643

)

 

$

(171,522

)

 

$

(201,618

)

 

$

(790,609

)

 

 

 

 

 

 

 

 

GAAP Net loss per common share - basic and diluted

$

(1.10

)

 

$

(1.68

)

 

$

(3.52

)

 

$

(9.30

)

Non-GAAP Net loss per common share - basic and diluted

$

(0.77

)

 

$

(1.39

)

 

$

(1.61

)

 

$

(6.50

)

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
December 31,

 

Twelve Months Ended
December 31,

(In thousands)

 

2023

 

 

2022

 

 

2023

 

 

2022

ONPATTRO net product revenues

$

79,006

 

$

122,221

 

$

354,546

 

$

557,608

AMVUTTRA net product revenues

 

175,254

 

 

68,566

 

 

557,838

 

 

93,795

Total TTR net product revenues

 

254,260

 

 

190,787

 

 

912,384

 

 

651,403

 

 

 

 

 

 

 

 

GIVLAARI net product revenues

 

59,298

 

 

47,058

 

 

219,251

 

 

173,144

OXLUMO net product revenues

 

32,730

 

 

23,830

 

 

109,839

 

 

69,782

Total net product revenues

$

346,288

 

$

261,675

 

$

1,241,474

 

$

894,329

 

Year over Year % Growth

 

Three Months Ended
December 31, 2023

 

Twelve Months Ended
December 31, 2023

 

As Reported

 

At CER*

 

As Reported

 

At CER*

Total TTR net product revenues

33

%

 

31

%

 

40

%

 

40

%

 

 

 

 

 

 

 

 

GIVLAARI net product revenues

26

%

 

24

%

 

27

%

 

26

%

OXLUMO net product revenues

37

%

 

32

%

 

57

%

 

55

%

Total net product revenues

32

%

 

30

%

 

39

%

 

39

%

 

* CER = Constant Exchange Rate, representing growth calculated as if the exchange rates had remained unchanged from those used in 2022. CER is a non-GAAP measure.

  • Net product revenues increased 32% and 39% at actual currency during the three and twelve months ended December 31, 2023, respectively, compared to the same periods in 2022, and 30% and 39% at CER, respectively. The increases are primarily due to increased patients on our commercial TTR therapies driven by the launch of AMVUTTRA in the third quarter of 2022 as well as increased patients on GIVLAARI and OXLUMO therapies.

Net Revenues from Collaborations

  • Net revenues from collaborations increased 8% and 305% during the three and twelve months ended December 31, 2023, respectively, as compared to the same periods in 2022, primarily due to revenue recognized under our Collaboration and License Agreement with Roche, as executed in July 2023, and revenue recognized under our Novartis Collaboration Agreement associated with the achievement of specified commercialization and regulatory milestones.

Operating Expenses

 

Three Months Ended
December 31,

 

Twelve Months Ended
December 31,

(In thousands)

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Cost of goods sold

$

71,975

 

 

$

46,172

 

 

$

268,216

 

 

$

140,174

 

Cost of goods sold as a percentage of net product revenues

 

20.8

%

 

 

17.6

%

 

 

21.6

%

 

 

15.7

%

 

 

 

 

 

 

 

 

Cost of collaborations and royalties

$

13,883

 

 

$

5,094

 

 

$

42,190

 

 

$

28,643

 

 

 

 

 

 

 

 

 

GAAP research and development expenses

$

272,141

 

 

$

262,039

 

 

$

1,004,415

 

 

$

883,015

 

Non-GAAP research and development expenses

$

253,056

 

 

$

245,095

 

 

$

907,142

 

 

$

790,854

 

 

 

 

 

 

 

 

 

GAAP selling, general and administrative expenses

$

198,123

 

 

$

210,344

 

 

$

795,646

 

 

$

770,658

 

Non-GAAP selling, general and administrative expenses

$

175,214

 

 

$

184,521

 

 

$

671,239

 

 

$

632,170

 

Cost of Goods Sold

  • Cost of goods sold as a percentage of net product revenues increased during the three and twelve months ended December 31, 2023, respectively, as compared to the same periods in 2022, primarily due to increased volume and rate of royalties payable on net sales of AMVUTTRA associated with tiered royalty percentages, in addition to increased excess and obsolete charges primarily due to canceling manufacturing commitments and the impairment of ONPATTRO inventory that had been manufactured for future demand associated with the ATTR amyloidosis with 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 three and twelve months ended December 31, 2023, compared to the same periods in 2022, primarily due to increased headcount and infrastructure expenses to support our R&D pipeline, development expenses associated with the KARDIA-1 and KARDIA-2 zilebesiran Phase 2 studies, and manufacturing and research related expenses associated with our pre-clinical and developmental activities. GAAP R&D expenses further increased during the twelve month period due to increased stock-based compensation expense related to the accounting for certain performance-based awards during the period.

Selling, General & Administrative (SG&A) Expenses

  • GAAP and non-GAAP SG&A expenses decreased during the three months ended December 31, 2023, compared to the same period in 2022, primarily due to increased legal expenses in 2022 associated with the Patent Infringement Lawsuits we filed in March 2022 and the Department of Justice investigation, which closed in August 2023, and increased expenses in support of the global launch of AMVUTTRA in the third quarter of 2022.
  • GAAP and non-GAAP SG&A expenses increased during the twelve months ended December 31, 2023, compared to the same period in 2022, primarily due to increased headcount and other strategic investments in support of the global launch of AMVUTTRA and other expenses to support our strategic growth.

Other Financial Highlights

  • Cash, cash equivalents and marketable securities were $2.44 billion as of December 31, 2023, compared to $2.19 billion as of December 31, 2022, with the increase primarily due to the receipts of a $310 million upfront payment from Roche in connection with our partnership to co-develop and co-commercialize zilebesiran, a $100 million payment from Regeneron in connection with the achievement of certain criteria during early clinical development for our CNS program, ALN-APP, and nearly $150 million from employee option award exercises, offset by our operating loss for the year.

A reconciliation of our GAAP to non-GAAP results for the current quarter is included in the tables at the end of this press release.

2024 Financial Guidance

Full year December 31, 2024 financial guidance consists of the following:

Combined net product revenues for AMVUTTRA, ONPATTRO, GIVLAARI and OXLUMO1

$1,400 million – $1,500 million

Net Product Revenue Growth vs. 2023 at reported Fx rates1

13% – 21%

Net Product Revenue Growth vs. 2023 at constant exchange rates*

13% – 21%

Net revenues from collaborations and royalties

$325 million – $425 million

GAAP R&D and SG&A expenses

$1,900 million - $2,050 million

Non-GAAP R&D and SG&A expenses2

$1,675 million – $1,775 million

 

 

1 Uses January 31, 2024 FX rates including: 1 EUR = 1.08 USD and 1 USD = 147 JPY

2 Primarily excludes $225-$275 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, 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, as applicable, 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 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 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 fourth quarter and full year 2023 results as well as expectations for the future via conference call on Thursday, February 15, 2024 at 8:30 am ET. To access the call, please register online at https://register.vevent.com/register/BI94c4772acd31430480d414497e322a2f. Participants are requested to register at least 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 adults with hATTR amyloidosis with polyneuropathy. 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 adults with hATTR amyloidosis with polyneuropathy. 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 (givosiran) 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 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 Cambridge, MA. For more information about our people, science and pipeline, please visit www.alnylam.com and engage with us on X (formerly Twitter) at @Alnylam, or on LinkedIn, Facebook, or 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, statements regarding Alnylam’s aspiration to become a top-tier biotech company, 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 commercial products, and Alnylam’s projected commercial and financial performance, including the expected range of net product revenues and net revenues from collaborations and royalties for 2024, the expected range of aggregate annual GAAP and non-GAAP R&D and SG&A expenses for 2024, the expected timing of topline data from the HELIOS-B Phase 3 clinical study, and the planned achievement of its “Alnylam P5x25” strategy, 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, risks and uncertainties relating to: 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 vutrisiran, zilebesiran, and ALN-APP; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, including 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 approved indications for 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; 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; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products, including Roche, Novartis, Sanofi, Regeneron and Vir; the outcome of litigation; the risk of future government investigations; and unexpected expenditures; as well as those risks and uncertainties more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. 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. 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 BALANCE SHEETS

(In thousands, except per share amounts)




 

 

December 31,
2023

 

December 31,
2022

ASSETS

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

812,688

 

 

$

866,394

 

Marketable debt securities

 

1,615,516

 

 

 

1,297,890

 

Marketable equity securities

 

11,178

 

 

 

28,122

 

Accounts receivable, net

 

327,787

 

 

 

237,963

 

Inventory

 

89,146

 

 

 

128,962

 

Prepaid expenses and other current assets

 

126,382

 

 

 

132,916

 

Total current assets

 

2,982,697

 

 

 

2,692,247

 

Property, plant and equipment, net

 

526,057

 

 

 

523,494

 

Operating lease right-of-use assets

 

199,732

 

 

 

215,136

 

Restricted investments

 

49,391

 

 

 

49,390

 

Other assets

 

72,003

 

 

 

66,092

 

Total assets

$

3,829,880

 

 

$

3,546,359

 

LIABILITIES AND STOCKHOLDERS’ DEFICIT

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

55,519

 

 

$

98,094

 

Accrued expenses

 

713,013

 

 

 

545,460

 

Operating lease liability

 

41,510

 

 

 

41,967

 

Deferred revenue

 

102,753

 

 

 

42,105

 

Liability related to the sale of future royalties

 

54,991

 

 

 

40,289

 

Total current liabilities

 

967,786

 

 

 

767,915

 

Operating lease liability, net of current portion

 

243,101

 

 

 

261,339

 

Deferred revenue, net of current portion

 

188,175

 

 

 

193,791

 

Convertible debt

 

1,020,776

 

 

 

1,016,942

 

Liability related to the sale of future royalties, net of current portion

 

1,322,248

 

 

 

1,252,015

 

Other liabilities

 

308,438

 

 

 

212,580

 

Total liabilities

 

4,050,524

 

 

 

3,704,582

 

Commitments and contingencies (Note 13)

 

 

 

Stockholders’ deficit:

 

 

 

Preferred stock, $0.01 par value per share, 5,000 shares authorized and no shares issued and outstanding as of December 31, 2023 and December 31, 2022

 

—

 

 

 

—

 

Common stock, $0.01 par value per share, 250,000 shares authorized as of December 31, 2023 and December 31, 2022, respectively; 125,794 shares issued and outstanding as of December 31, 2023; 123,925 shares issued and outstanding as of December 31, 2022

 

1,259

 

 

 

1,240

 

Additional paid-in capital

 

6,811,063

 

 

 

6,454,540

 

Accumulated other comprehensive loss

 

(23,375

)

 

 

(44,654

)

Accumulated deficit

 

(7,009,591

)

 

 

(6,569,349

)

Total stockholders’ deficit

 

(220,644

)

 

 

(158,223

)

Total liabilities and stockholders’ deficit

$

3,829,880

 

 

$

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 December 31, 2023.

 

ALNYLAM PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)




 

 

Three Months Ended
December 31,

 

Twelve Months Ended
December 31,

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

 

(Unaudited)

 

(Unaudited)

 

 

 

 

Revenues:

 

 

 

 

 

 

 

Net product revenues

$

346,288

 

 

$

261,675

 

 

$

1,241,474

 

 

$

894,329

 

Net revenues from collaborations

 

76,407

 

 

 

70,645

 

 

 

546,185

 

 

 

134,912

 

Royalty revenue

 

17,023

 

 

 

2,715

 

 

 

40,633

 

 

 

8,177

 

Total revenues

 

439,718

 

 

 

335,035

 

 

 

1,828,292

 

 

 

1,037,418

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

Cost of goods sold

 

71,975

 

 

 

46,172

 

 

 

268,216

 

 

 

140,174

 

Cost of collaborations and royalties

 

13,883

 

 

 

5,094

 

 

 

42,190

 

 

 

28,643

 

Research and development

 

272,141

 

 

 

262,039

 

 

 

1,004,415

 

 

 

883,015

 

Selling, general and administrative

 

198,123

 

 

 

210,344

 

 

 

795,646

 

 

 

770,658

 

Total operating costs and expenses

 

556,122

 

 

 

523,649

 

 

 

2,110,467

 

 

 

1,822,490

 

Loss from operations

 

(116,404

)

 

 

(188,614

)

 

 

(282,175

)

 

 

(785,072

)

Other (expense) income:

 

 

 

 

 

 

 

Interest expense

 

(31,338

)

 

 

(29,913

)

 

 

(121,221

)

 

 

(155,968

)

Interest income

 

30,406

 

 

 

14,077

 

 

 

95,561

 

 

 

24,808

 

Other expense, net

 

(20,351

)

 

 

(2,571

)

 

 

(125,682

)

 

 

(134,175

)

Loss on the extinguishment of debt

 

—

 

 

 

—

 

 

 

—

 

 

 

(76,586

)

Total other expense, net

 

(21,283

)

 

 

(18,407

)

 

 

(151,342

)

 

 

(341,921

)

Loss before income taxes

 

(137,687

)

 

 

(207,021

)

 

 

(433,517

)

 

 

(1,126,993

)

Provision for income taxes

 

(183

)

 

 

(472

)

 

 

(6,725

)

 

 

(4,163

)

Net loss

$

(137,870

)

 

$

(207,493

)

 

$

(440,242

)

 

$

(1,131,156

)

Net loss per common share — basic and diluted

$

(1.10

)

 

$

(1.68

)

 

$

(3.52

)

 

$

(9.30

)

Weighted-average common shares used to compute basic and diluted net loss per common share

 

125,613

 

 

 

123,266

 

 

 

124,906

 

 

 

121,689

 




 

ALNYLAM PHARMACEUTICALS, INC.

RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES

(In thousands, except per share amounts)

(Unaudited)




 

 

Three Months Ended
December 31,

 

Twelve Months Ended
December 31,

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Reconciliation of GAAP to Non-GAAP research and development:

 

 

 

 

 

 

 

GAAP Research and development

$

272,141

 

 

$

262,039

 

 

$

1,004,415

 

 

$

883,015

 

Less: Stock-based compensation expenses

 

(19,085

)

 

 

(16,944

)

 

 

(97,273

)

 

 

(92,161

)

Non-GAAP Research and development

$

253,056

 

 

$

245,095

 

 

$

907,142

 

 

$

790,854

 

 

 

 

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP selling, general and administrative:

 

 

 

 

 

 

 

GAAP Selling, general and administrative

$

198,123

 

 

$

210,344

 

 

$

795,646

 

 

$

770,658

 

Less: Stock-based compensation expenses

 

(22,909

)

 

 

(25,823

)

 

 

(124,407

)

 

 

(138,488

)

Non-GAAP Selling, general and administrative

$

175,214

 

 

$

184,521

 

 

$

671,239

 

 

$

632,170

 

 

 

 

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP operating loss:

 

 

 

 

 

 

 

GAAP operating loss

$

(116,404

)

 

$

(188,614

)

 

$

(282,175

)

 

$

(785,072

)

Add: Stock-based compensation expenses

 

41,994

 

 

 

42,767

 

 

 

221,680

 

 

 

230,649

 

Non-GAAP Operating loss

$

(74,410

)

 

$

(145,847

)

 

$

(60,495

)

 

$

(554,423

)

 

 

 

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP Other (expense) income:

 

 

 

 

 

 

 

GAAP Total other expense, net

$

(21,283

)

 

$

(18,407

)

 

$

(151,342

)

 

$

(341,921

)

(Less) Add: Realized and unrealized (gain) loss on marketable equity securities

 

(767

)

 

 

(6,796

)

 

 

16,944

 

 

 

33,312

 

Add: Loss on the extinguishment of debt

 

—

 

 

 

—

 

 

 

—

 

 

 

76,586

 

Non-GAAP Other expense, net

$

(22,050

)

 

$

(25,203

)

 

$

(134,398

)

 

$

(232,023

)

 

 

 

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP net loss:

 

 

 

 

 

 

 

GAAP Net loss

$

(137,870

)

 

$

(207,493

)

 

$

(440,242

)

 

$

(1,131,156

)

Add: Stock-based compensation expenses

 

41,994

 

 

 

42,767

 

 

 

221,680

 

 

 

230,649

 

(Less) Add: Realized and unrealized (gain) loss on marketable equity securities

 

(767

)

 

 

(6,796

)

 

 

16,944

 

 

 

33,312

 

Add: Loss on the extinguishment of debt

 

—

 

 

 

—

 

 

 

—

 

 

 

76,586

 

Non-GAAP Net loss

$

(96,643

)

 

$

(171,522

)

 

$

(201,618

)

 

$

(790,609

)

 

 

 

 

 

 

 

 

Reconciliation of GAAP to Non-GAAP net loss per common share-basic and diluted:

 

 

 

 

 

 

 

GAAP Net loss per common share - basic and diluted

$

(1.10

)

 

$

(1.68

)

 

$

(3.52

)

 

$

(9.30

)

Add: Stock-based compensation expenses

 

0.33

 

 

 

0.35

 

 

 

1.77

 

 

 

1.90

 

(Less) Add: Realized and unrealized (gain) loss on marketable equity securities

 

(0.01

)

 

 

(0.06

)

 

 

0.14

 

 

 

0.27

 

Add: Loss on the extinguishment of debt

 

—

 

 

 

—

 

 

 

—

 

 

 

0.63

 

Non-GAAP Net loss per common share - basic and diluted

$

(0.77

)

 

$

(1.39

)

 

$

(1.61

)

 

$

(6.50

)

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, 2023

 

Three Months
Ended

 

Twelve Months
Ended

Total TTR net product revenue growth, as reported

33

%

 

40

%

Add: Impact of foreign currency translation

(2

)

 

—

 

Total TTR net product revenue growth at constant currency

31

%

 

40

%

 

 

 

 

GIVLAARI net product revenue growth, as reported

26

%

 

27

%

Add: Impact of foreign currency translation

(2

)

 

(1

)

GIVLAARI net product revenue growth at constant currency

24

%

 

26

%

 

 

 

 

OXLUMO net product revenue growth, as reported

37

%

 

57

%

Add: Impact of foreign currency translation

(5

)

 

(2

)

OXLUMO net product revenue growth at constant currency

32

%

 

55

%

 

 

 

 

Total net product revenue growth, as reported

32

%

 

39

%

Add: Impact of foreign currency translation

(2

)

 

—

 

Total net product revenue growth at constant currency

30

%

 

39

%

 

 

 

 

Total revenue growth, as reported

31

%

 

76

%

Add: Impact of foreign currency translation

(2

)

 

—

 

Total revenue growth at constant currency

29

%

 

76

%

 

Contacts

Alnylam Pharmaceuticals, Inc.
Christine Regan Lindenboom
(Investors and Media)
617-682-4340

Josh Brodsky
(Investors)
617-551-8276

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