EX-99.1 2 amrn-ex99_1.htm EX-99.1 EX-99.1

 

第99.1展示文本

img114078973_0.jpg

 

阿瑪琳報告2024年第三季度財務結果並提供業務更新

 

-- 現金儲備強勁,達到30600萬美元;9th 連續第9個季度現金餘額爲正或中立 --

 

--總淨營業收入4200萬美元代表繼續來源於美國、國際合作夥伴關係和歐洲初期推出階段的現金流--

 

-- 歐洲積極勢頭持續,價格與報銷工作取得進展,營業收入增長主要由西班牙和英國推動 --

 

-- 公司將於11月14日舉辦虛擬分析師與投資者日 --

 

-- 公司仍致力於保持公開上市狀態 --

 

愛爾蘭都柏林和新澤西布里奇沃特,2024年10月30日 -- 阿瑪琳有限公司(納斯達克:AMRN)今天報告了截至2024年9月30日的第三季度財務業績,並提供了業務更新。

在阿瑪琳,公司的產品 - VASCEPA®/VAZKEPA® (伊科萘酯) - 在全球具有顯著的增長和價值潛力。這一點不斷得到全球進展的證實。在本季度,VAZKEPA的銷售在歐洲按季度增長了19%,主要受西班牙和英國的推動。值得注意的是,在意大利,公司已經與意大利當局採取了額外措施,並希望能很快分享資訊。

在美國,公司通過第三季度在IPE市場上保持了超過50%的份額。因此,美國業務在過去九個季度持續產生超過30000萬美元的顯著現金,面對持續的仿製藥競爭。此外,公司繼續評估授權仿製藥推出的潛在最佳時機。

在評價公司及其第三季度業績時,阿里嵩(Amarin)的總裁兼首席執行官亞倫·伯格(Aaron Berg)表示:「我們和全球合作伙伴繼續執行我們多管齊下的全球戰略,以將VASCEPA/VAZKEPA產品推廣給儘可能多的患者,公司高級領導團隊和我以及董事會將繼續致力於評估所有機會,以最大限度地發揮這一高度有影響力的產品的價值和影響。爲此,我們期待着突出VASCEPA/VAZKEPA的全球機遇,並在即將舉行的11月14日的虛擬分析師和投資者日上直接聽取來自世界各地處方者和選擇合作伙伴對VASCEPA/VAZKEPA影響的看法。」

繼續說,伯格表示:「我們對我們的上市完全投入-對我們和股東都非常重要。除了繼續推動業務外,我們還有許多途徑可以解決這個問題。」

 


 

第三季度運營亮點

阿瑪琳繼續推進定價和報銷工作,覆蓋歐洲和其他國際市場,包括:
o
在意大利,公司進一步與定價和報銷部門取得進展,公司希望能夠很快分享更多更新;
o
在葡萄牙,爲VAZKEPA獲得了國家資助。
o
在澳洲,與我們的合作伙伴CSL Seqirus合作,在澳大利亞獲得了VAZKEPA的全國報銷,CSL現在正式推出該產品。
調查人員在歐洲心臟病學會議(ESC)上提出了具有重大意義的REDUCE-IT®心血管結果試驗與VASCEPA/VAZKEPA的新細分數據,以及展示二十碳五烯酸(EPA)機制活動的摘要。
調查人員在第60屆歐洲糖尿病研究協會(EASD)會議上介紹了關於VASCEPA/VAZKEPA對糖尿病和高心血管風險患者的臨床影響以及EPA對抗脂蛋白(a)氧化的機制影響的新研究。

財務更新

財務亮點

(單位:百萬美元)

2024年9月30日止三個月

2023年9月30日結束的三個月

百分比變動

營業收入總淨額

$42.3

$66.1

-36%

研究和開發1

$41.4

$50.5

-18%

現金

$305.7

$320.7

-5%

1 – 不包括2023年9月30日結束的3個月內的重組支出$700,000

2024年9月30日結束的三個月的總淨營業收入爲4230萬美元,相較於2023年同期的6610萬美元,下降了36%。2024年9月30日結束的三個月的淨產品收入爲4190萬美元,相較於2023年同期的6490萬美元,下降了36%。這種下降主要是由於美國仿製藥競爭帶來的淨銷售價格影響以及由於CVS從獨家帳戶轉移到不再覆蓋VASCEPA而導致銷量主要下降引起的。截至2024年9月30日結束的三個月,美國淨產品收入爲3060萬美元,相較於2023年同期的6240萬美元。截至2024年9月30日結束的三個月,歐洲淨產品收入爲430萬美元,其餘世界(RoW)淨產品收入爲690萬美元,相較於2013年同期的80萬美元和180萬美元,分別有所增長。

截至2024年9月30日的三個月的營業成本爲2600萬美元,低於2023年同期的3620萬美元。2024年和2023年截至9月30日的淨產品營業收入的毛利率分別爲38%和44%。不包括2023年第三季度的存貨重組費用,毛利率爲64%。

2024年9月30日結束的三個月內,銷售、一般和管理費用爲3690萬美元,而2023年同期爲4550萬美元。這種減少主要是由於全面業務成本優化努力導致的。

 


 

2024年9月30日結束的三個月內,研發費用爲450萬美元,而2023年對應期間爲510萬美元。

根據美國通用會計準則,截至2024年9月30日,公司報告淨損失爲2510萬美元,基本和稀釋每股虧損爲0.06美元。這個淨損失中包括470萬美元的非現金股權補償。截至2023年9月30日,公司報告淨損失爲1930萬美元,基本和稀釋每股虧損爲0.05美元。這個淨損失包括460萬美元的非現金股權補償費用。

在排除非現金股票補償費用和重組費用的情況下,2024年9月30日結束的三個月的非GAAP調整淨虧損爲2040萬美元,相應的非GAAP調整基本和稀釋每股虧損爲0.05美元,相比之下,2023年9月30日結束的三個月的非GAAP調整淨虧損爲130萬美元,相應的非GAAP調整基本和稀釋每股虧損爲0.00美元。

截至2024年9月30日,公司報告的現金和投資總額爲30570萬美元,其中包括本季度收到的1500萬美元EDDING CVRR里程碑付款,相比之下,截至2024年6月30日的現金和投資總額爲30670萬美元。

2024年財務展望。

The Company is committed to executing against the significant opportunity in Europe. The Company is focused on maintaining market share in the U.S. and maximizing cash generation from the attractive and growing Rest of World (RoW) income stream. The Company continues to make progress on reducing operating expenses and managing its cash position, including $10 million of operating expense savings in the third quarter of 2024 compared to the third quarter of 2023. The Company reaffirms its belief that current cash and investments and other assets are adequate to support continuing operations for the foreseeable future.

Virtual Analyst & Investor Day 2024 – November 14

Amarin will host a virtual analyst and investor day on Thursday, November 14, 2024, from 8:00 AM EST to 10:00 AM EST. The event will be hosted by members of the Amarin senior management team and will focus on updating the investment community on the current state of the VASCEPA/VAZKEPA franchise, with particular attention given to discussions on the dynamics of key geographies that represent the future value of the franchise, including Europe. In addition, a dedicated question and answer session will be held during which the Amarin senior management team will entertain questions submitted in advance to investor.relations@amarincorp.com.

As a virtual event, the program will be webcast and archived for future reference and will be open to all participants; participation will require a simple registration step before joining, which will be available through the Company website prior to this event. Throughout the event, there will be no live interaction with audience participants.

Q3 2024 Earnings Conference Call and Webcast Information

Amarin will host a conference call on October 30, 2024, at 5:00 p.m. ET to discuss this information. The conference call can be accessed on the investor relations section of the company's website at www.amarincorp.com, or via telephone by dialing 888-506-0062 within the United States, 973-528-0011 from outside the United States, and referencing conference ID 732244. A replay of the call will be made available for a period of two weeks following the conference call. To listen to a replay of the call, dial 877-481-4010 from within the United States and 919-882-2331 from outside of the United States, and reference conference ID 51361. A replay of the call will also be available through the company's website shortly after the call.

 


 

About Amarin

Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.

About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules

VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for the treatment of high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than twenty-five million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Kuwait, Saudi Arabia, Qatar and Bahrain. In Europe, in March 2021 marketing authorization was granted via a centralized procedure for icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. VAZKEPA (icosapent ethyl) is currently sold in Europe in Sweden, Finland, Austria, the UK (including England, Wales & Scotland and Northern Ireland), Spain, Portugal, Greece and the Netherlands. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland, Wales and Northern Ireland).

United States
Indications and Limitation of Use

VASCEPA is indicated:

As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and
o
established cardiovascular disease or
o
diabetes mellitus and two or more additional risk factors for cardiovascular disease.
As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia.

The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information

VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.
It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.

 


 

VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).
Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding.

FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Europe

For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.medicines.org.uk/emc/product/12964/smpc.

Globally, prescribing information varies; refer to the individual country product label for complete information.

Use of Non-GAAP Adjusted Financial Information

Included in this press release are non-GAAP adjusted financial information as defined by U.S. Securities and Exchange Commission Regulation G. The GAAP financial measure most directly comparable to each non-GAAP adjusted financial measure used or discussed, and a reconciliation of the differences between each non-GAAP adjusted financial measure and the comparable GAAP financial measure, is included in this press release after the condensed consolidated financial statements.

Non-GAAP adjusted net (loss) income was derived by taking GAAP net loss and adjusting it for non-cash stock-based compensation expense, restructuring expense and other one-time expenses. Management uses these non-GAAP adjusted financial measures for internal reporting and forecasting purposes, when publicly providing its business outlook, to evaluate the company’s performance and to evaluate and compensate the company’s executives. The company has provided these non-GAAP financial measures in addition to GAAP financial results because it believes that these non-GAAP adjusted financial measures provide investors with a better understanding of the company’s historical results from its core business operations.

While management believes that these non-GAAP adjusted financial measures provide useful supplemental information to investors regarding the underlying performance of the company’s business operations, investors are reminded to consider these non-GAAP measures in addition to, and not as a substitute for, financial performance measures prepared in accordance with GAAP. Non-GAAP measures have limitations in that they do not reflect all of the amounts associated with the company’s results of operations as determined in accordance with GAAP. In addition, it should be noted that these non-GAAP financial measures may be different from non-GAAP measures used by other companies, and management may utilize other measures to illustrate performance in the future.

Forward-Looking Statements

 


 

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s key achievements in 2023 and the potential impact and outlook for achievements in 2024 and beyond; Amarin’s 2024 financial outlook and cash position; Amarin’s overall efforts to expand access and reimbursement to VAZKEPA across global markets; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin generally. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including Amarin’s quarterly report on Form 10-Q for the period ending September 30, 2024 and annual report on Form 10-K for the full year ended 2023. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. Amarin’s forward-looking statements do not reflect the potential impact of significant transactions the company may enter into, such as mergers, acquisitions, dispositions, joint ventures or any material agreements that Amarin may enter into, amend or terminate.

 

Availability of Other Information About Amarin

Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (www.amarincorp.com/investor-relations), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

 

Amarin Contact Information

Investor & Media Inquiries:

Mark Marmur

Amarin Corporation plc

PR@amarincorp.com

-Tables to Follow-

 

 


 

CONSOLIDATED BALANCE SHEET DATA

 

(U.S. GAAP)

 

Unaudited

 

 

 

 

 

 

 

 

 

 

September 30, 2024

 

 

December 31, 2023

 

 

 

(in thousands)

 

ASSETS

 

 

 

 

 

 

Current Assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

156,944

 

 

$

199,252

 

Restricted cash

 

 

526

 

 

 

525

 

Short-term investments

 

 

148,788

 

 

 

121,407

 

Accounts receivable, net

 

 

112,642

 

 

 

133,563

 

Inventory

 

 

224,000

 

 

 

258,616

 

Prepaid and other current assets

 

 

7,316

 

 

 

11,618

 

Total current assets

 

 

650,216

 

 

 

724,981

 

Property, plant and equipment, net

 

 

24

 

 

 

114

 

Long-term inventory

 

 

74,023

 

 

 

77,615

 

Operating lease right-of-use asset

 

 

7,984

 

 

 

8,310

 

Other long-term assets

 

 

1,250

 

 

 

1,360

 

Intangible asset, net

 

 

17,118

 

 

 

19,304

 

TOTAL ASSETS

 

$

750,615

 

 

$

831,684

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current Liabilities:

 

 

 

 

 

 

Accounts payable

 

$

40,507

 

 

$

52,762

 

Accrued expenses and other current liabilities

 

 

161,047

 

 

 

204,174

 

Current deferred revenue

 

 

 

 

 

2,341

 

Total current liabilities

 

 

201,554

 

 

 

259,277

 

Long-Term Liabilities:

 

 

 

 

 

 

Long-term deferred revenue

 

 

 

 

 

2,509

 

Long-term operating lease liability

 

 

8,215

 

 

 

8,737

 

Other long-term liabilities

 

 

9,471

 

 

 

9,064

 

Total liabilities

 

 

219,240

 

 

 

279,587

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock

 

 

305,202

 

 

 

302,756

 

Additional paid-in capital

 

 

1,911,445

 

 

 

1,899,456

 

Treasury stock

 

 

(65,344

)

 

 

(63,752

)

Accumulated deficit

 

 

(1,619,928

)

 

 

(1,586,363

)

Total stockholders’ equity

 

 

531,375

 

 

 

552,097

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

750,615

 

 

$

831,684

 

 

 

 


 

CONSOLIDATED STATEMENTS OF OPERATIONS DATA

 

(U.S. GAAP)

 

Unaudited

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

(in thousands, except per share amounts)

 

 

(in thousands, except per share amounts)

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Product revenue, net

$

41,852

 

 

$

64,903

 

 

$

144,522

 

 

$

214,744

 

Licensing and royalty revenue

 

446

 

 

 

1,153

 

 

 

21,786

 

 

 

17,454

 

Total revenue, net

 

42,298

 

 

 

66,056

 

 

 

166,308

 

 

 

232,198

 

Less: Cost of goods sold

 

26,022

 

 

 

23,560

 

 

 

75,359

 

 

 

72,553

 

Less: Cost of goods sold - restructuring inventory

 

 

 

 

12,674

 

 

 

 

 

 

39,228

 

Gross margin

 

16,276

 

 

 

29,822

 

 

 

90,949

 

 

 

120,417

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative (1)

 

36,904

 

 

 

45,457

 

 

 

115,340

 

 

 

155,997

 

Research and development (1)

 

4,540

 

 

 

5,105

 

 

 

14,884

 

 

 

16,428

 

Restructuring

 

 

 

 

711

 

 

 

 

 

 

10,743

 

Total operating expenses

 

41,444

 

 

 

51,273

 

 

 

130,224

 

 

 

183,168

 

Operating loss

 

(25,168

)

 

 

(21,451

)

 

 

(39,275

)

 

 

(62,751

)

Interest income, net

 

3,374

 

 

 

3,216

 

 

 

10,028

 

 

 

8,438

 

Other income (expense), net

 

265

 

 

 

(575

)

 

 

1,954

 

 

 

3,092

 

Loss from operations before taxes

 

(21,529

)

 

 

(18,810

)

 

 

(27,293

)

 

 

(51,221

)

Provision for income taxes

 

(3,605

)

 

 

(501

)

 

 

(6,272

)

 

 

(2,110

)

Net loss

$

(25,134

)

 

$

(19,311

)

 

$

(33,565

)

 

$

(53,331

)

Loss per share:

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.06

)

 

$

(0.05

)

 

$

(0.08

)

 

$

(0.13

)

Diluted

$

(0.06

)

 

$

(0.05

)

 

$

(0.08

)

 

$

(0.13

)

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

Basic

 

411,150

 

 

 

408,417

 

 

 

410,786

 

 

 

407,489

 

Diluted

 

411,150

 

 

 

408,417

 

 

 

410,786

 

 

 

407,489

 

 

 

 

 

 

 

 

 

 

 

 

 

(1) - Excluding non-cash stock-based compensation, selling, general and administrative expenses were $33,075 and $41,807 for the three months ended September 30, 2024 and 2023, respectively, and research and development expenses were $3,671 and $4,113, respectively, for the same periods.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

 

RECONCILIATION OF NON-GAAP NET INCOME (LOSS)

 

Unaudited

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

(in thousands, except per share amounts)

 

 

(in thousands, except per share amounts)

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Net loss for EPS1 - GAAP

 

(25,134

)

 

 

(19,311

)

 

 

 

(33,565

)

 

 

 

(53,331

)

Stock-based compensation expense

 

 

4,698

 

 

 

4,643

 

 

 

 

14,303

 

 

 

 

12,034

 

Restructuring inventory

 

 

 

 

 

12,674

 

 

 

 

 

 

 

 

39,228

 

Restructuring expense

 

 

 

 

 

711

 

 

 

 

 

 

 

 

10,743

 

Advisor fees

 

 

 

 

 

 

 

 

 

 

 

 

 

6,270

 

Net (loss) income for EPS1 - non-GAAP

 

$

(20,436

)

 

$

(1,283

)

 

 

$

(19,262

)

 

 

$

14,944

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1basic and diluted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Loss) earnings per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic - non-GAAP

 

$

(0.05

)

 

$

(0.00

)

 

 

$

(0.05

)

 

 

$

0.04

 

Diluted - non-GAAP

 

$

(0.05

)

 

$

(0.00

)

 

 

$

(0.05

)

 

 

$

0.04

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

411,150

 

 

 

408,417

 

 

 

 

410,786

 

 

 

 

407,489

 

Diluted

 

 

411,150

 

 

 

408,417

 

 

 

 

410,786

 

 

 

 

417,117