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— EE. UU. se industry trends stabilize and operational project progress translates into extended money —
— VAZKEPA® (icosapent ethyl) launches in England and Wales in mid-October as –
— Obtained a clinical evaluation for reimbursement in Italy and the Netherlands and received a national reimbursement in Finland —
–Ongoing market negotiations for VAZKEPA underway in several major European markets, adding final value negotiations in Spain —
— The company will host the convention call at 8:00 a. m. m. EDT —
DUBLIN, Ireland and BRIDGEWATER, New Jersey, Oct. 27, 2022 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), announced its currency effects for the quarter ended September 30, 2022 and provided an update on the company’s operations.
“In the third quarter of 2022, Amarin made significant progress in achieving its key priorities and long-term expansion strategy, evidenced through the company’s advanced monetary position, posting a positive quarter in monetary restructuring charges. We remain confident in the opportunities ahead and in our direction for the rest of 2022 and into 2023,” said Karim Mikhail, President and Chief Executive Officer of Amarin.
“In Europe, we are on track to meet our commitment to safe value and reimbursement approval in up to 8 European markets and launch in up to six European markets this year, and we remain confident of our billion-dollar earnings opportunity. in the third quarter of 2022, we control secure global pricing and reimbursements in Finland as well as individual pricing and refunds in Austria. Repayments received in England and Wales, Northern Ireland and Sweden, individual reimbursement in Denmark and positive clinical assessments in France, Italy and the Netherlands. We also anticipate possible reimbursement decisions until the end of the year and the beginning of 2023 in Spain, Italy, Norway, the Netherlands and France.
“In the U. S. , we are pleased with the continued stabilization of our VASCEPA® business and our functionality in the market. This was our third consecutive quarter of solid earnings in the U. S. This was achieved through our team’s focus on selling the VASCEPA brand. In the US, steps were also taken before 2022 to reduce our prices and monetary position. Implementation of a comprehensive cost-saving plan began materializing in the third quarter and is on track to generate $100 million in cost savings. * through mid-2023 In addition, we continue to make progress in renegotiating our source acquisition agreements.
“We are also advancing our efforts to raise awareness and understanding about VASCEPA/VAZKEPA science, and the super clinical price our product offers to reduce cardiovascular (CV) threat in patients with high and ultra high threat. Regarding the leadership idea, we actively identify a presence and teach the healthcare network at key cardiovascular meetings and congresses around the world, adding a major attendance to the European Society of Cardiology Congress in August, the Canadian Cardiovascular Congress in October, and the upcoming American Heart Association clinical sessions in We also continue to advance the progression of our mixture to constant dose VASCEPA with a statin and strengthening and expanding our control team to help the company’s long-term strategy.
“As we review our achievements in the third quarter and enter the fourth quarter of the year, we remain self-confident in our long-term strategy and future opportunities to execute an ambitious vision to prevent Cinput’s disease from being the leading cause of patient death worldwide. ” Mr. Mikhail concluded.
Europe ×
To date, Amarin is making adequate progress to secure the patient to VAZKEPA through local negotiations over the form, and those negotiations will continue to progress for the remainder of 2022 and into 2023. Launch activities also continue to progress in Sweden.
Safe and VAZKEPA pricing in Finland and Northern Ireland, with ample access for patients, such as in England/Wales and Sweden.
In addition, Amarin received an individual reimbursement for VAZKEPA in Austria, in addition to the individual reimbursement in Denmark received this year; The company plans to reintroduce broader pricing and rebates in those countries in the coming months. Clinical evaluation and fitness generation processes and reimbursement discussions are progressing in all target markets in Europe where Amarin has submitted market requests, adding Spain, France, Italy, the Netherlands. , Norway, Portugal, Scotland, Switzerland and Israel.
Price negotiations are being concluded with the Spanish Ministry of Health, which could allow a possible resolution of prices and reimbursement before the end of 2022.
In Italy, our record has moved from clinical evaluation of negotiations to pricing and reimbursement of discussions with regulators in this market.
In the Netherlands, we got positive advice from the National Institute of Health Care (ZIN) for reimbursement and plan to start valuable negotiations with the Dutch Ministry of Health.
As a reminder, Amarin won a refund from the HAS, the High Health Authority, and tariff negotiations continue to progress.
Usa. UU
Net sales of products in the U. S. U. S. prices were $87. 9 million in the third quarter of 2022, a low of $2. 8 million compared to the current quarter of 2022, reflecting minimal impact on pricing and volumes. The company continues to retain more than 60% of the market. percentage of the IPE molecule despite generic competition, and U. S. industry organizationThe U. S. Department of State proceeded to withhold the specific aid of the VASCEPA brand. These revenues continue to help investments in Europe and expand into new markets.
Amarin continues to actively monitor KPIs in the U. S. market. The U. S. government is to advance its strategy.
International
Amarin continues to advance its purpose of unlocking VASCEPA’s potential internationally. The company is in the process of submitting regulatory filings for approval in 20 additional countries so that patients in the world’s 50 most sensitive cardiometabolic markets can benefit from VASCEPA. Marketing authorization programs for Amarin for VASCEPA in Australia and New Zealand continue to advance in accordance with local procedures.
Additionally, Amarin continues to progress those efforts with our partners, including:
Eddingpharm (Asia) Macau Commercial Offshore Limited (Edding), Amarin’s spouse in China, recently obtained confirmation that the Chinese government has finished the product and initiated the era of final review before approval. Our spouse indicated that he still expects to receive approval before the end of the year.
In Canada, HLS Therapeutics, Inc. has been reimbursed through all primary public payers and continues to contribute to the public sector.
Financial update
Total net revenue for the three months ended September 30, 2022 was $89. 9 million, compared to $142. 0 million in the corresponding era of 2021, a low of 37%. Net product sales for the three months ended September 30, 2022 were $89. 2 million. , compared to $141. 4 million for the corresponding era of 2021, a low of 37%. This minimum was driven to reduce the volume and reduce the net value of the promotion due to the influence of a larger generic festival in the United States. As a reminder, during the quarter ended September 30, 2022, there were 3 or more generic competitors in the U. S. market. The U. S. compared to two generic competitors in the U. S. market. U. S. during the quarter ended September 30, 2021.
Amarin identified licensing and royalty revenues of approximately $0. 7 million and $0. 6 million in the 3 months ended September 30, 2022 and 2021, respectively, from VASCEPA-related sales from our partners in Canada, the China region and the Middle East.
Cost of goods sold during the 3 months ended September 30, 2022 was $27. 0 million, compared to $30. 2 million in the corresponding era of 2021. Amarin’s overall gross margin on product net revenue for the 3 months ended September 30, 2022 was 70%. compared to 79% for the corresponding era of 2021. During the quarter ended September 30, 2022, Amarin took steps to modify supplier agreements to align source agreements with existing and long-term market demand, resulting in a rate of $3. 1 million. It has an effect on this item, the gross margin was 73% for the 3 months ended September 30, 2022.
Selling, general and administrative expenses for the three months ended September 30, 2022 were $58. 7 million, compared to $103. 0 million in the same period last fiscal year. This reduction is primarily due to the implementation of our fee relief plan announced in June and was partially offset through investments in advertising operations in Europe.
Research and development expenses for the three-month period ended September 30, 2022 were $5. 8 million, compared to $7. 8 million for the same period last fiscal year. This reduction is primarily due to the implementation of our fee relief plan announced in June and partially offset through prices incurred similar to the progression of a fixed-dose mixture of VASCEPA with a statin.
In August 2022, the company announced the closure of the German operations due to the inability to reach a viable agreement on the reimbursement value of VAZKEPA in Germany. As a result, the company incurred restructuring charges in the total amount of $4. 4 million, substantially all of which were cash expenses incurred in the 3rd quarter of 2022.
Under US GAAP, Amarin reported a net loss of $5. 1 million for the third quarter ended September 30, 2022, or a consistent fundamental and diluted loss at a consistent percentage of $0. 01. This net loss includes $5. 0 million in non-cash share-based write-downs and $6. 6 million in restructuring costs. For the third quarter ended September 30, 2021, Amarin reported a net loss of $13. 2 million, or a consistent fundamental and diluted loss at a consistent percentage of $0. 03. This net loss included $10. 4 million of non-cash share-based redemption fees and $14. 1 million of restructuring fees. Excluding non-cash share-based redemption fees and restructuring fees, adjusted non-GAAP net income source $6. 4 million for the third quarter ended September 30, 2022 or adjusted core and diluted non-GAAP benefit consistent with a percentage of $0. 02, compared to non-GAAP adjusted net earnings of $11. 4 million for the third quarter ended September 30, 2021, or core and diluted earnings through a non-GAAP consistent adjusted percentage of $0. 03 . As of September 30, 2022, Amarin reported total cash and investments of $306. 0 million.
*Compared to 2021 GAAP operating expenses and restructuring charges.
Financial Perspective 2022
Given the uncertainty resulting from the impact of the generic IEP in the US,With the U. S. and demanding conditions for most drugs looking to enter the market in Europe, Amarin will continue to suspend its earnings guidance for 2022.
The stabilization of the company’s revenues in the U. S. Recent money preservation projects have resulted in a prolonged cash flow for the company. Amarin believes that the money, investments and other existing assets are sufficient to continue operations, and adds launch activities in Europe.
Information about conference calls and webcasts:
Amarin will host a conference call on October 27, 2022 at 8:00 a. m. m. , Eastern Time, to discuss this information. The conference call will be held on the investor relations segment of the Company’s online page in www. amarincorp. com, or by telephone at 888-506-0062 in the United States, 973-528-0011 from outside the United States and referencing convention ID 367970. There will be a repeat call for a period of two weeks after the call convention. To pay attention to a repeat call, dial 877-481-4010 from within the United States and 919-882-2331 from outside the United States, and reference convention ID 46629. A repeat call will also be available through the company’s online page a while after the call.
Use of Non-GAAP Adjusted Financial Information
This press release includes non-GAAP adjusted monetary data as explained through Regulation G of the U. S. Securities and Exchange Commission. The GAAP adjusted monetary measure and the comparable GAAP monetary measure are included in this press release after the condensed consolidated monetary statements.
Non-GAAP adjusted net income (loss) received by taking GAAP net loss and adjusting for stock-based non-cash redemption expenses and restructuring charges. publicly publish its business outlook, compare the Company’s functionality, and compare and compensate Company officers. The Company has provided such non-GAAP monetary measures in addition to GAAP currency effects because it believes that such adjusted non-GAAP monetary measures allow investors to better perceive the Company’s past effects of its core business activities.
While the control believes that such adjusted non-GAAP monetary measures provide more useful data for investors regarding the underlying functionality of the Company’s business activities, investors are reminded that such non-GAAP measures are additional to and do not replace monetary functionality. GAAP ready measures. Non-GAAP measures are limited in that they do not reflect all amounts related to the effects of the Company’s operations as decided in accordance with GAAP. In addition, it should be noted that these non-GAAP monetary measures may differ from non-GAAP measures used through other companies, and control would likely use other measures to illustrate long-term functionality.
About Amarin
Amarin is a cutting-edge pharmaceutical company at the forefront of a new paradigm in the management of cardiovascular disease. From our clinical studies base to our focus on clinical trials, and now to our global business expansion, we are evolving and developing rapidly. Amarin has offices in Bridgewater, New Jersey in the U. S. The U. S. , Dublin, Ireland, Zug in Switzerland and other European countries, as well as business partners and suppliers worldwide. We are committed to rethinking cardiovascular threat by advancing clinical understanding of the effect on society of a significant residual threat that exists beyond classical therapies, such as statins for cholesterol control.
About VASCEPA® (ethyl icosapent) capsules
VASCEPA (icosapent ethyl) pills are the first and only prescription remedy approved by the US Food and Drug Administration (FDA) that consists solely of the active ingredient, icosapent ethyl (IPE), a proprietary form of eicosapentaenoic acid. VASCEPA was introduced in the United States in January 2020 as the first and only drug approved by the US FDA for the treatment of patients with persistent cardiovascular risk after statin cure. VASCEPA was originally introduced in the United States in 2013 based on the drug’s initial FDA-approved indication for use as an adjunct cure to nutrition to lower triglyceride levels in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL). Since its launch, VASCEPA has been prescribed more than ten million times. VASCEPA is covered through maximum primary health insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, Lebanon, and the United Arab Emirates. In Europe, in March 2021, the marketing authorization for icosapent ethyl was granted in the European Union for the alleviation of the risk of cardiovascular events in patients with high cardiovascular risk, under the brand name VAZKEPA.
Indications and Limitations of Use (in the United States)
VASCEPA is indicated:
In addition to maximally tolerated statin therapy in the face of threatened myocardial infarction, stroke, coronary revascularization, and volatile angina requiring hospitalization in adult patients with elevated triglycerides (TG) (≥ 150 mg/dL) and
established cardiovascular or
diabetes mellitus and at least two more points for cardiovascular disease.
As an adjunct to nutrition to TG grades in adult patients with severe hypertriglyceridemia (≥ 500 mg/dL). The effect of VASCEPA on the threat of pancreatitis in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information
VASCEPA is contraindicated in patients with hypersensitivity reaction (p. e. g. , anaphylactic reaction) to VASCEPA or any of its components.
VASCEPA was associated with an increased threat (3% vs. 2%) of traumatic atrial inflammation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The occurrence of traumatic upper atrial inflammation in patients with a history of atrial trauma, inflammation or atrial flutter.
It is not known whether patients allergic to fish and/or shellfish are at increased risk of an allergic reaction to VASCEPA. Patients with such allergies discontinue use of VASCEPA if reactions occur.
VASCEPA was associated with an increased threat (12% vs. 10%) of bleeding in a double-blind, placebo-controlled trial. The occurrence of upper bleeding in patients receiving concomitant antithrombotic drugs, such as aspirin, clopidogrel, or warfarin.
Common adverse reactions in the cardiovascular outcomes trial (incidence ≥ 3% and ≥ 1% more not unusual than placebo): musculoskeletal pain (4% versus 3%), peripheral oedema (7% versus 5%), constipation (5% 4%), gout (4% versus 3%), and traumatic atrial inflammation (5% versus 4%).
Common adverse reactions in hypertriglyceridemia trials (incidence > 1% more not unusual than placebo): arthralgia (2% versus 1%) and oropharyngeal pain (1% versus 0. 3%).
Adverse occasions can be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Patients receiving VASCEPA and concomitant anticoagulants and/or antiplatelet agents should be monitored for bleeding.
COMPLETE INFORMATION ON THE U. S. FDA-APPROVED VASCEPA PRESCRIPTIONUU. SE CAN BE FOUND AT WWW. VASCEPA. COM.
Forward-Looking Statements
This press release comprises forward-looking statements, within the meaning of United States securities laws, and adds, but is not limited to, VASCEPA’s global market-related trusts; expectations related to monetary and functional measures such as prescription expansion, earnings expansion, operating expenses, share purchases and controlled care policy for VASCEPA, adding the effect of the COVID-19 pandemic, the disappointing final results of patent litigation and the generic party release on those measures; confidence that Amarin is well placed to achieve its expansion goals for VASCEPA in the United States and beyond; confidences about patients’ wishes for VASCEPA; the effects of the COVID-19 pandemic on Amarin’s operations and at times in the healthcare industry, the effects of which remain fluid; confidence that Amarin’s strategy to reduce the effects of cardiovascular disease is sound and that Amarin is achieving good results with physicians, payers, pharmacists and patients; the timing and effects of regulatory filings and reviews, recommendations and approvals and reimbursement decisions and similar publicity releases in Europe, the China region and elsewhere; plans for the planned launch of VASCEPA through Amarin directly in the primary European market, either directly or indirectly; trust in the cardioprotective and other benefits of VASCEPA; relies on the strength of knowledge in market position position access logs and other reports; expectations related to the timing, effectiveness, and impact of promotional activities, including patient-focused campaigns, conferences and poster presentations, and education of health professionals; business and foreign expansion, prescription and earnings expansion and long-term earnings grades, adding contributions from sales representatives and the new control team; confidence that Amarin’s existing resources are sufficient to fund the proposed operations; and the effect of the COVID-19 pandemic on all of the above. These forward-looking statements are neither promises nor promises and involve very broad threats and uncertainties. Amarin’s ability to market position position position position position position position position VASCEPA well and maintain or develop its market position position position position position position percentage position will depend in part on Amarin’s ability to continue financing its business well, with the approval of VASCEPA in geographic spaces outside the United States United States, third component efforts, Amarin’s ability to create and build marketpositionpositionpositionpositionpositionpositionpositionpositionposition for VASCEPA through education, marketpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositioning and sales activities, to achieve wide acceptance of VASCEPA in the marketpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionpositionposition to achieve good enough degrees of reimbursement from payers of the third component, to expand and maintain a constant source of pu source advertising at a competitive price, to meet legal and regulatory needs in connection with the sale and promotion of VASCEPA, and to secure, maintain, and preserve your patent protection for VASCEPA. Items that may also cause actual effects to differ slightly from those described or expected in this document include: the option that VASCEPA may not obtain regulatory approval in the China region or other geographies on time or at all ; the threat that more generic versions of VASCEPA will enter the market position position position position position position position position and that the generic versions of VASCEPA will download a greater market position position position position position position percentage and source of advertising than expected, is That is, in light of the disappointing final results of the Amarin litigation compared to two generic drug corporations and the following appeals; the threat that the scope and duration of the COVID-19 pandemic will continue to affect access to and sales of VASCEPA; the threat that Amarin has overstated VASCEPA’s market position in the United States, Europe and other geographies; relevant threats with the expansion of Amarin’s business; sometimes relevant uncertainties with studies and expansion, clinical trials and similar regulatory approvals; the threat that sales will not meet expectations and corresponding prices may possibly exceed expectations; and the threat that the patents would possibly decide not to be infringed or invalid in patent litigation and that the programs would not result in enough patents being issued to protect VASCEPA’s franchise. A more detailed list and description of such threats, uncertainties and other threats relevant to an investment in Amarin would possibly be discovered in Amarin’s filings with the United States Securities and Exchange Commission, adding Amarin’s Annual Report in the Form 10-K for the fiscal year ended. December 31, 2021. Quarterly and Parent Report on Form 10-Q for the quarter ended September 30, 2022. Existing and prospective investors are cautioned not to place undue reliance on such forward-looking statements. Array that is valid only on the date they are made. Amarin assumes no legal responsibility to update or revise any data contained in its forward-looking statements, whether as a result of new data, long-term events or occurrences or otherwise. Amarin’s forward-looking statements do not reflect the potential effect of curtain transactions in which the company would be involved, such as mergers, acquisitions, divestitures, joint ventures or any curtain agreements in which Amarin would enter, modify or terminate.
Availability of more about Amarin
Investors and others deserve to note that Amarin communicates with its investors and the public through the Company’s online page (www. amarincorp. com), the online investor relations (investor. amarincorp. com) page, adding, among others, investor presentations and investor FAQs. , United States. Securities and Exchange Commission documents, press releases, public convention calls and webcasts. The data published through Amarin on those channels and websites can also be considered vital data. in Amarin to review the data published on those channels, adding the online investor relations page. This list of channels may be updated from time to time on Amarin’s online investor relations page and possibly come with social media channels. The content of the Amarin Online Site or those channels, or any other online pages available from its online site or such channels, shall not be deemed to be incorporated through ugh reference in a filing under the Securities Act 1933.
Amarin InquiriesInvestor:Lisa DeFrancescoAmarin Corporation Investor Relations plcinvestor. relations@amarincorp. com (investor solicitations)
Media Questions:
Mark MarmurCorporate Communications, Amarin Corporation plcPR@amarincorp. com (Media Inquiries)
-Tables to follow-
CONSOLIDATED BALANCE SHEET DATA
(US GAAP)
Unaudited
September 30, 2022
December 31, 2021
(thousands)
ASSETS
Current assets:
Cash and cash equivalents
Ps
240 498
Ps
219 454
Allocated money flow
3 920
3 918
Short-term investments
63 203
234 674
Accounts receivable, net
123 379
163 653
Inventory
227 606
234 676
Prepaid and existing assets
27 914
22 352
Total assets
686 520
878 727
Tangible capital assets, net
999
1 425
Long-term investments
2 264
34,996
Long-term inventory
187,964
121 254
Use operating lease asset
8 462
7 660
Other long-term assets
456
456
Intangible assets, net
21 638
23 547
TOTAL ASSETS
Ps
908 303
Ps
1 068 065
COMMITMENTS AND EQUITY
Current liabilities:
Accounts Payable
Ps
93 157
Ps
114 922
Accrued liabilities and existing liabilities
192 001
253 111
Current deferred revenue
2 198
2 649
Total Liability
287 356
370 682
Long-term liabilities:
Long-term deferred revenue
13 499
14 060
Long-term lease liabilities
9 924
8 576
Other long-term liabilities
9 697
7 648
Total responsibilities
320 476
400 966
Equity:
Share
298 596
294 027
Share premium
1 878 923
1 855 246
Own shares
(61 585
)
(60 726
)
Accumulated deficit
(1 528 107
)
(1 421 448
)
Total equity of shareholders
587 827
667 099
TOTAL LIABILITIES AND EQUITY
Ps
908 303
Ps
1 068 065
CONSOLIDATED STATEMENTS OF OPERATIONS
(US GAAP)
Unaudited
Three months ended September 30
Nine months ended 30 September
(thousands, consistent with participation)
(thousands, consistent with participation)
2022
2021
2022
2021
Product turnover, net
Ps
89 222
Ps
141 442
Ps
277 004
Ps
436 598
License and royalty revenue
656
596
1 944
2 098
Total revenue, net
89 878
142 038
278 948
438 696
Less: of goods sold
23 941
30 211
81 990
90 692
Less: Cost of Goods Sold – Inventory Restructuring
3 078
—
18 078
—
Gross margin
62 859
111 827
178 880
348 004
Operating costs:
Sales & Administration (1)
58 745
102 965
236 285
315 966
Research and (1)
5 765
7 820
25 172
23 554
Restructuring
3 493
14 115
13 706
14 115
Total operating expenses
68 003
124 900
275 163
353 635
Business interruption
(5 144
)
(13 073
)
(96 283
)
(5 631
)
Interest income, net
750
163
1 241
919
Other source of income (expenses), net
511
(57
)
(1 990
)
(390
)
Operating loss taxes
(3 883
)
(12 967
)
(97 032
)
(5 102
)
Provision for the source of income tax
(1 257
)
(184
)
(9 627
)
(1 867
)
Net loss
Ps
(5 140
)
Ps
(13 151
)
Ps
(106 659
)
Ps
(6 969
)
Loss consistent with participation:
Basic
Ps
(0,01
)
Ps
(0,03
)
Ps
(0,27
)
Ps
(0,02
)
Diluted
Ps
(0,01
)
Ps
(0,03
)
Ps
(0,27
)
Ps
(0,02
)
Weighted actions:
Basic
404 614
396 618
399 944
395 681
Diluted
404 614
396 618
399 944
395 681
(1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were $54,358 and $93,723 for the 3 months ended September 30, 2022 and 2021, respectively, and progression expenses were $5,138 and $6,630, respectively, for the same periods.
NON-GAAP NET INCOME RECONCILIATION (LOSS)
Unaudited
Three months ended September 30
Nine months ended 30 September
(thousands, consistent with participation)
(thousands, consistent with participation)
2022
2021
2022
2021
UPA1 – GAAP Net Loss
(5 140
)
(13 151
)
(106 659
)
(6 969
)
Non-cash share-based reimbursement expense
5 015
10 432
20 192
26 836
Inventory restructuring
3 078
—
18 078
—
Restructuring costs
3 493
14 115
13 706
14 115
EPS1 Adjusted Earnings (Loss) – Non-GAAP
Ps
6 446
Ps
11 396
Ps
(54 683
)
Ps
33 982
1basic and diluted
Profit (loss) consistent with participation:
Basic – GAAP
Ps
0,02
Ps
0,03
Ps
(0,14
)
Ps
0,09
Diluted – GAAP
Ps
0,02
Ps
0,03
Ps
(0,14
)
Ps
0,08
Weighted actions:
Basic
404 614
396 618
399 944
395 681
Diluted
405 541
402 657
399 944
402 657