Clopidogrel besylate

CINCINNATI, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Blue Water Biotech, Inc. (“Blue Water” or the “Company”), a biotechnology and pharmaceutical company spanning multiple sectors, today announced the signing of an agreement with Copay Consultants, LLC (“Copay Consultants”) to build copay assistance programs for Blue Water’s commercial products, including ENTADFI®, which was acquired in April and ZONTIVITY®, which is expected to be acquired in the coming weeks after the signing of an asset purchase agreement in June. Copay Consultants team has over 40 years of combined experience in the life science industry, including creation of manufacturer sponsored patient savings programs, pharmacy adjudicated copay discount programs, direct to patient rebates, patient web enrollment and attestation services, patient messaging, among others. In this new effort, Blue Water’s commercial team will work closely with Copay Consultants to design and implement a copay assistance program for eligible ENTADFI® and ZONTIVITY® patients. “Oftentimes, getting a prescription and securing insurance coverage is only the first step in the process of a patient initiating therapy,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. “When patients arrive at the pharmacy and are exposed to high out of pocket costs, copay assistance programs like these can prove critical to ensuring those patients begin treatment. With our copay programs and through this collaboration with Copay Consultants, we are excited to show our commitment to patients across the country and their ability to afford our treatments.” After the acquisition of ENTADFI® in April and signing of an asset purchase agreement to acquire ZONTIVITY® in June, Blue Water management presented its commercial launch strategy in a letter to shareholders last month. Recent execution includes significant progress with Blue Water collaborators and vendors across sales, marketing, advertising, telehealth development, market access, and sample distribution. This new agreement with Copay Consultants is expected to help eligible patients lower the out of pocket costs associated with treatment and is another critical step towards the official launch of these products, expected in the coming months. About ENTADFI® ENTADFI® is an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a more effective treatment option compared to other available therapies. Clinical trials have shown that ENTADFI® is more effective in treating BPH symptoms, including urinary frequency, urgency, weak stream, and difficulty initiating or maintaining urination, compared to finasteride monotherapy. Additionally, ENTADFI® has demonstrated a favorable safety profile, with fewer adverse sexual side effects compared to finasteride. ENTADFI® reduces potential for adverse sexual side effects, making it a preferred choice for men seeking relief from BPH symptoms without compromising their sexual health. ENTADFI® has received FDA approval for the indication of initiating treatment of the signs and symptoms of BPH in men with an enlarged prostate for up to 26 weeks. More information about BPH and full ENTADFI® prescribing information can be found on the product website at About ZONTIVITY® ZONTIVITY® is a once daily, oral treatment indicated for the reduction of thrombotic cardiovascular events for patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY® has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization when used with aspirin and/or clopidogrel. More information about MI, PAD, and full ZONTIVITY® prescribing information can be found on the product website at . About Copay Consultants Copay Consultants, LLC is a service provider in the marketing and patient access space within the life science industry. Working as an extension of marketing and market access teams, Copay Consultants develops manufacture sponsored savings programs catered to individual products, market trends and competitive landscape which provide affordable access for patients. For more information about Copay Consultants, visit About Blue Water Biotech Blue Water Biotech, Inc. is a biotechnology and pharmaceutical company focused on developing and commercializing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of benign prostatic hyperplasia without the negative sexual side effects typically seen in patients on finasteride alone. The Company is also in the process of acquiring the approved therapies from WraSer, LLC, and Xspire Pharma, LLC, including ZONTIVITY® (reduction of thrombotic cardiovascular events in patients with myocardial infarction or with peripheral arterial disease), OTOVEL® (acute otitis media with tympanostomy tubes), CETRAXAL® (acute otitis externa), CONJUPRI® (hypertension), TREZIX™ (moderate to severe pain) and NALFON® (NSAID treatment for pain and inflammation). The Company also has a robust preclinical vaccine pipeline. Blue Water holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as AOM, in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus S&P nanoparticle versatile virus-like particle vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. For more information about Blue Water, visit . Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements (including, without limitation, the anticipated benefits of the Company’s agreement with Copay Consultants) are based on Blue Water’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, market and other conditions, risks related to Blue Water’s ability to realize the benefits of its acquisitions of ENTADFI®, ZONTIVITY®, OTOVEL®, CETRAXAL®, CONJUPRI®, TREZIX™ and NALFON®; risks related to Blue Water’s ability to expand its business scope, commercialize ENTADFI® and integrate the assets and commercial operations being acquired from WraSer, LLC, and Xspire Pharma, LLC into Blue Water’s business; risks related to Blue Water’s ability to attract, hire and retain skilled personnel and establish an effective sales team; risks related to Blue Water’s ability to establish, maintain and optimize key third party commercial collaboration agreements (such as those with Knipper, UpScript, IQVIA, APS and bfw); risks related to the Company’s present need for capital to close its asset acquisitions, commercially launch the Company’s acquired products and have adequate working capital; risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any commercial-stage pharmaceutical product or any product candidate under clinical development, there are significant risks in the development, regulatory approval and commercialization of pharmaceutical products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Blue Water’s Annual Report on Form 10-K, filed with the SEC on March 9, 2023 and periodic reports filed with the SEC on or after the date thereof. All of Blue Water’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Media Contact Information: Blue Water Media Relations Telephone: (646) 942-5591 Email: Nic.Johnson@russopartnersllc.com Investor Contact Information: Blue Water Investor Relations Email: investors@bwbioinc.com

-- Company Delivers Total Revenues of $75 Million in the Fourth Quarter and $306 Million for the Full-Year 2023 ---- Reaffirms Year-End 2023 Cash Position of $321 Million and Full-Year Positive Cash Flow of $10 Million -- -- Company Reports Fourth Quarter 2023 Total Operating Expense of $50 Million ---- Initiated Shareholder Approval Process to Execute a Share Repurchase Program of up to $50 Million by the End of the Second Quarter 2024 ---- Company to Host Conference Call Today at 8:00 a.m. EDT -- DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), today announced financial results for the quarter and year ended December 31, 2023 and provided an update on the Company’s operations. “Our team is delivering operational momentum in the business. As previously announced in January, in Europe we are showing early signs of progress, particularly in Spain and the U.K.; our U.S. business is continuing its IPE market leadership; and our Rest of World (ROW) partners are advancing plans to maximize patient uptake,” said Patrick Holt, President & CEO of Amarin. “We have initiated the shareholder approval process to execute up to a $50 million share repurchase program. Our focus remains on building momentum in 2024 and beyond for Amarin.” Financial UpdateTotal net revenue for the three months ended December 31, 2023 was $74.7 million, compared to $90.2 million in the corresponding period of 2022, a decrease of 17%. Net product revenue for the three months ended December 31, 2023 was $70.6 million, compared to $89.5 million in the corresponding period of 2022, a decrease of 21%. This decrease was driven primarily by a decrease in volume of VASCEPA sales to Amarin’s customers in the United States, which were adversely impacted by generic availability in the United States. USA net product revenue was $64.9 million for the three months ended December 31, 2023 compared to $88.0 million in the corresponding period of 2022. For the three months ended December 31, 2023, European net product revenue was $1.5 million and Rest of World (RoW) net product revenue was $4.2 million primarily from supply shipments to our partner Edding. Amarin recognized licensing and royalty revenue of approximately $4.2 million for the three months ended December 31, 2023 compared to $0.7 million in the corresponding period of 2022 from VASCEPA-related regulatory milestones, including the cardiovascular risk reduction (CVRR) submission, and commercial sales from our partners in Canada, the China region and the Middle East. Cost of goods sold for the three months ended December 31, 2023 was $29.6 million, compared to $26.6 million in the corresponding period of 2022. Amarin’s overall gross margin on net product revenue for the three months ended December 31, 2023 was 58%, compared with 70% for the corresponding period of 2022. Selling, general and administrative expenses for the three months ended December 31, 2023 was $43.9 million, compared to $68.1 million in the corresponding period of the prior year. This decrease was primarily due to a reduction in costs from the elimination of our U.S. sales force as part of our organizational restructuring program and previous cost reduction plan and was partially offset by ongoing investments to support commercial operations in Europe. Research and development expenses for the three months ended December 31, 2023 were $5.8 million, compared to $5.2 million in the corresponding period of the prior year. Under U.S. GAAP, Amarin reported a net loss of $5.8 million for the three months ended December 31, 2023, or basic and diluted loss per share of $0.01. This net loss includes $4.6 million in non-cash stock-based compensation. For the three months ended December 31, 2022, Amarin reported net income of $0.9 million, or basic and diluted earnings per share of $0.00. This net income included $6.6 million in non-cash stock-based compensation expense. Excluding non-cash stock-based compensation expense and restructuring expense, non-GAAP adjusted net loss was $0.9 million for the three months ended December 31, 2023 or non-GAAP adjusted basic and diluted loss per share of $0.00, compared with non-GAAP adjusted net income of $7.3 million for the three months ended December 31, 2022, or non-GAAP adjusted basic and diluted earnings per share of $0.02. As of December 31, 2023, Amarin reported aggregate cash and investments of $321 million. 2024 Financial Outlook Amarin continues to make progress on reducing operating expenses and managing its cash position and is on-track to deliver $40 million of annual savings based on the reduction in force announced in July 2023. With the recent cash preservation initiatives, Amarin reiterates its belief that current cash and investments and other assets are adequate to support continued operations including the share repurchase program. We will continue to focus on cash preservation and prudently invest in the right opportunities which are value additive. Conference Call and Webcast InformationAmarin will host a conference call on February 29, 2024, at 8:00 a.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 996476. 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 49775. A replay of the call will also be available through the company's website shortly after the call. About AmarinAmarin 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 treatment of the studied 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 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, Lebanon and the United Arab Emirates. In Europe, in March 2021 marketing authorization was granted to 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. In April 2021 marketing authorization for VAZKEPA (icosapent ethyl) was granted in Great Britain (applying to England, Scotland and Wales). VAZKEPA (icosapent ethyl) is currently approved and sold in Europe in Sweden, Denmark, Finland, Austria, the UK, Spain and the Netherlands. United StatesIndications and Limitation of UseVASCEPA 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 established cardiovascular disease or 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 click here. Globally, prescribing information varies; refer to the individual country product label for complete information. Additional Information Regarding Amarin Share Repurchase Agreement The implementation of the repurchase agreement is conditional upon shareholder and UK court approval, as required under UK company law. The Company intends to accelerate its annual general meeting of shareholders early in the second quarter of 2024 in order to seek such shareholder approval, following which it will proceed with the requisite court process to undertake a reduction of capital in order to create the necessary distributable profits for the funding of the repurchases. Amarin anticipates that these steps could be completed by the end of the second quarter of 2024, with share repurchases commencing shortly thereafter. Following receipt of the requisite approvals, Cantor will purchase such ADSs in compliance with the safe harbor provisions of Rule 10b-18 of the U.S. securities laws and the terms of the approved repurchase contract. The repurchase program will conclude at such time as Cantor has purchased $50 million of ADSs, unless terminated earlier by either Amarin or Cantor, as provided for in the repurchase agreement. Subject to the necessary shareholder and court approvals being obtained, the repurchases will be funded out of distributable profits utilizing the Company’s existing cash resources. The repurchase program was approved by the Amarin board in compliance with UK company law regarding distributions and the maintenance of capital. A copy of the repurchase agreement will be available for inspection by Amarin’s shareholders at the registered office address of Amarin in the run up to the 2024 annual general meeting and, once entered into, will be available for inspection for at least 10 years from the date of such agreement. 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 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 and restructuring expense. 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 StatementsThis 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 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. Implementation of the share repurchase program is subject to shareholder and UK court approval, which may not be obtained in a timely manner or at all; Cantor may be unable to repurchase some or all of the ADSs within the parameters provided for in the share repurchase agreement; and the share repurchase may not have the expected results. Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), 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 InformationInvestor & Media Inquiries:Mark MarmurAmarin Corporation plcPR@amarincorp.com CONSOLIDATED BALANCE SHEET DATA (U.S. GAAP) Unaudited * December 31, 2023 December 31, 2022 (in thousands) ASSETS Current Assets: Cash and cash equivalents $199,252 $217,666 Restricted cash 525 523 Short-term investments 121,407 91,695 Accounts receivable, net 133,563 130,990 Inventory 258,616 228,732 Prepaid and other current assets 11,618 19,492 Total current assets 724,981 689,098 Property, plant and equipment, net 114 874 Long-term investments — 1,275 Long-term inventory 77,615 163,620 Operating lease right-of-use asset 8,310 9,074 Other long-term assets 1,360 458 Intangible asset, net 19,304 21,780 TOTAL ASSETS $831,684 $886,179 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $52,762 $64,602 Accrued expenses and other current liabilities 204,174 192,678 Current deferred revenue 2,341 2,199 Total current liabilities 259,277 259,479 Long-Term Liabilities: Long-term deferred revenue 2,509 13,147 Long-term operating lease liability 8,737 10,015 Other long-term liabilities 9,064 8,205 Total liabilities 279,587 290,846 Stockholders’ Equity: Common stock 302,756 299,002 Additional paid-in capital 1,899,456 1,885,352 Treasury stock (63,752) (61,770) Accumulated deficit (1,586,363) (1,527,251) Total stockholders’ equity 552,097 595,333 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $831,684 $886,179 * Unaudited as a standalone schedule; copied from consolidated financial statements CONSOLIDATED STATEMENTS OF OPERATIONS DATA (U.S. GAAP) Unaudited * Three Months Ended December 31, Year Ended December 31, (in thousands, except per share amounts) (in thousands, except per share amounts) 2023 2022 2023 2022 Product revenue, net$70,555 $89,507 $285,299 $366,511 Licensing and royalty revenue 4,158 738 21,612 2,682 Total revenue, net 74,713 90,245 306,911 369,193 Less: Cost of goods sold 29,589 26,641 102,142 108,631 Less: Cost of goods sold - restructuring inventory — — 39,228 18,078 Gross margin 45,124 63,604 165,541 242,484 Operating expenses: Selling, general and administrative (1) 43,941 68,131 199,938 304,416 Research and development (1) 5,791 5,239 22,219 30,411 Restructuring 229 (180) 10,972 13,526 Total operating expenses 49,961 73,190 233,129 348,353 Operating loss (4,837) (9,586) (67,588) (105,869) Interest income 3,419 1,564 11,863 2,819 Interest expense (2) (1) (8) (15) Other (expense) income, net (1,029) 1,250 2,063 (740) Loss from operations before taxes (2,449) (6,773) (53,670) (103,805) (Provision for) benefit from income taxes (3,332) 7,629 (5,442) (1,998) Net (loss) income$(5,781) $856 $(59,112) $(105,803) (Loss) earnings per share: Basic$(0.01) $0.00 $(0.15) $(0.26) Diluted$(0.01) $0.00 $(0.15) $(0.26) Weighted average shares outstanding: Basic 408,485 399,491 407,655 401,155 Diluted 408,485 401,696 407,655 401,155 * Unaudited as a standalone schedule; copied from consolidated financial statements (1) Excluding non-cash stock-based compensation, selling, general and administrative expenses were 187,445 and 282,076 for 2023 and 2022, respectively, and research and development expenses were 18,032 and 25,946, respectively, for the same periods. RECONCILIATION OF NON-GAAP NET (LOSS) INCOME Unaudited Three months ended December 31, Year Ended December 31, (in thousands, except per share amounts) (in thousands, except per share amounts) 2023 2022 2023 2022 Net (loss) income for EPS - GAAP $(5,781) $856 $(59,112) $(105,803) Stock-based compensation expense 4,646 6,612 16,680 26,805 Restructuring Inventory — — 39,228 18,078 Restructuring expense 229 (180) 10,972 13,526 Advisor Fees — — 6,270 — Adjusted net (loss) income for EPS - non-GAAP $(906) $7,288 $14,038 $(47,394) Basic and diluted (Loss) earnings per share: Basic - non-GAAP $(0.00) $0.02 $0.03 $(0.12) Diluted - non-GAAP $(0.00) $0.02 $0.03 $(0.12) Weighted average shares: Basic 408,485 399,491 407,655 401,155 Diluted 408,485 401,696 422,966 401,155