Collagenase Clostridium histolyticum(Biospecifics Technologies Corp. /Topical Collagenase Bus/)

DUBLIN, Nov. 6, 2023 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) today reported financial results for the third-quarter ended September 30, 2023. THIRD-QUARTER FINANCIAL PERFORMANCE (in thousands, except per share amounts) __________ CONSOLIDATED FINANCIAL RESULTS Total revenues were $452 million in third-quarter 2023, a decrease of 17% compared to $542 million in third-quarter 2022. This decrease was primarily attributable to decreased revenues from the Generic Pharmaceuticals and Sterile Injectables segments. Reported loss from continuing operations in third-quarter 2023 was $28 million compared to reported loss from continuing operations of $718 million in third-quarter 2022. This change was primarily due to lower litigation-related and asset impairment charges and lower interest expense as a result of the August 2022 Chapter 11 filing. Adjusted income from continuing operations in third-quarter 2023 was $131 million compared to $112 million in third-quarter 2022. This change was primarily driven by lower interest and adjusted operating expenses which were partially offset by decreased revenues. BRANDED PHARMACEUTICALS SEGMENT Third-quarter 2023 Branded Pharmaceuticals segment revenues were $203 million compared to $204 million during third-quarter 2022. Specialty Products revenues increased 3% to $150 million in third-quarter 2023 compared to $146 million in third-quarter 2022. This change was primarily due to an increase in XIAFLEX® and Other Specialty revenues, partially offset by a decrease in SUPPRELIN® LA revenues mainly driven by lower average net selling price as a result of business mix and lower overall market volumes. Third-quarter 2023 XIAFLEX® revenues were $113 million, a 9% increase compared to third-quarter 2022 driven by increased net selling price and increased volumes. Established Products revenues decreased 7% to $53 million in third-quarter 2023 compared to $57 million in third-quarter 2022 due primarily to product discontinuations. STERILE INJECTABLES SEGMENT Third-quarter 2023 Sterile Injectables segment revenues were $95 million, a decrease of 20% compared to $119 million during third-quarter 2022. This change was primarily attributable to decreased VASOSTRICT® revenues due to lower price resulting from generic competition. GENERIC PHARMACEUTICALS SEGMENT Third-quarter 2023 Generic Pharmaceuticals segment revenues were $134 million, a decrease of 33% compared to $201 million during third-quarter 2022. This decrease was primarily attributable to competitive pressure on varenicline tablets, the generic version of Chantix®, and lubiprostone capsules, the authorized generic of Mallinckrodt's Amitiza®, partially offset by revenue from dexlansoprazole delayed release capsules, the generic version of Dexilant®, which launched during fourth-quarter 2022. During third-quarter 2023, two additional generic varenicline competitors entered the market, and an additional competitor entered in early fourth-quarter 2023. INTERNATIONAL PHARMACEUTICALS SEGMENT Third-quarter 2023 International Pharmaceuticals segment revenues were $19 million, essentially unchanged compared to $18 million during third-quarter 2022. FINANCIAL EXPECTATIONS Endo's third-quarter 2023 adjusted financial results exceeded the expectations assumed in the low end of the prior outlook for the full-year ending December 31, 2023, primarily driven by higher revenue from dexlansoprazole delayed release capsules due to fewer than expected competitors, partially offset by lower varenicline revenues due to increased competition. Additionally, expected full-year 2023 adjusted financial results reflect lower-than-expected XIAFLEX® demand and SUPPRELIN® LA net selling price as well as better than expected Sterile Injectables performance. The financial expectations reflect adjusted results. All financial expectations provided by Endo are forward-looking, and actual results may differ materially from such expectations, as further discussed below under the heading "Cautionary Note Regarding Forward-Looking Statements." CASH, CASH FLOW AND OTHER UPDATES As of September 30, 2023, the Company had approximately $823 million in unrestricted cash and cash equivalents. Third-quarter 2023 net cash provided by operating activities was approximately $131 million compared to approximately $92 million net cash provided by operating activities during third-quarter 2022. This increase was primarily attributable to a decrease in cash interest payments and certain one-time payments made in third-quarter 2022 but not in third-quarter 2023, partially offset by a decrease in adjusted EBITDA. Amitiza® is a registered trademark of a Mallinckrodt company. Dexilant® is a registered trademark of Takeda Pharmaceutical U.S.A., Inc. Chantix® is a registered trademark of Pfizer Inc. FINANCIAL SCHEDULES The following table presents Endo's unaudited Total revenues, net for the three and nine months ended September 30, 2023 and 2022 (dollars in thousands): __________ The following table presents unaudited Condensed Consolidated Statement of Operations data for the three and nine months ended September 30, 2023 and 2022 (in thousands, except per share data): The following table presents unaudited Condensed Consolidated Balance Sheet data at September 30, 2023 and December 31, 2022 (in thousands): The following table presents unaudited Condensed Consolidated Statement of Cash Flow data for the nine months ended September 30, 2023 and 2022 (in thousands): __________ SUPPLEMENTAL FINANCIAL INFORMATION To supplement the financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP financial measures. For additional information on the Company's use of such non-GAAP financial measures, refer to Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission, which includes an explanation of the Company's reasons for using non-GAAP measures. The tables below provide reconciliations of certain of the Company's non-GAAP financial measures to their most directly comparable GAAP amounts. Refer to the "Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures" section below for additional details regarding the adjustments to the non-GAAP financial measures detailed throughout this Supplemental Financial Information section. Reconciliation of EBITDA and Adjusted EBITDA (non-GAAP) The following table provides a reconciliation of Net loss (GAAP) to Adjusted EBITDA (non-GAAP) for the three and nine months ended September 30, 2023 and 2022 (in thousands): Reconciliation of Adjusted Income from Continuing Operations (non-GAAP) The following table provides a reconciliation of the Company's Loss from continuing operations (GAAP) to Adjusted income from continuing operations (non-GAAP) for the three and nine months ended September 30, 2023 and 2022 (in thousands): Reconciliation of Other Adjusted Income Statement Data (non-GAAP) The following tables provide detailed reconciliations of various other income statement data between the GAAP and non-GAAP amounts for the three and nine months ended September 30, 2023 and 2022 (in thousands, except per share data): Notes to the Reconciliations of GAAP and Non-GAAP Financial Measures Notes to certain line items included in the reconciliations of the GAAP financial measures to the non-GAAP financial measures for the three and nine months ended September 30, 2023 and 2022 are as follows: Non-GAAP Financial Measures The Company utilizes certain financial measures that are not prescribed by or prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP net income and its components and diluted net income per share amounts. Despite the importance of these measures to management in goal setting and performance measurement, the company stresses that these are non-GAAP financial measures that have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. Because of the non-standardized definitions, non-GAAP adjusted EBITDA and non-GAAP adjusted net income from continuing operations and its components (unlike GAAP net income from continuing operations and its components) may not be comparable to the calculation of similar measures of other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses performance. Investors are encouraged to review the reconciliations of the non-GAAP financial measures used in this press release to their most directly comparable GAAP financial measures. However, the Company does not provide reconciliations of projected non-GAAP financial measures to GAAP financial measures, nor does it provide comparable projected GAAP financial measures for such projected non-GAAP financial measures. The Company is unable to provide such reconciliations without unreasonable efforts due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations, including adjustments that could be made for asset impairments, contingent consideration adjustments, legal settlements, gain / loss on extinguishment of debt, adjustments to inventory and other charges reflected in the reconciliation of historic numbers, the amounts of which could be significant. See Endo's Current Report on Form 8-K furnished today to the U.S. Securities and Exchange Commission for an explanation of Endo's non-GAAP financial measures. About Endo Endo (OTC: ENDPQ) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from passionate team members around the globe collaborating to bring treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Learn more at or connect with us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements Certain information in this press release may be considered "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and any applicable Canadian securities legislation, including, but not limited to, statements with respect to financial guidance, expectations or outlook, the restructuring support agreement and the sale transaction, the Chapter 11 proceedings, and any other statements that refer to Endo's expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "plan," "will," "may," "look forward," "outlook," "guidance," "future," "potential" or similar expressions are forward-looking statements. All forward-looking statements in this communication reflect the Company's current views as of the date of this communication about its plans, intentions, expectations, strategies and prospects, which are based on the information currently available to it and on assumptions it has made. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: the timing, impact or results of any pending or future litigation (including any appeals or injunctions), investigations, proceedings or claims, including opioid, tax and antitrust related matters; actual or contingent liabilities; settlement discussions or negotiations; the Company's liquidity, financial performance, cash position and operations; the Company's strategy; risks and uncertainties associated with Chapter 11 proceedings; the negative impacts on the Company's businesses as a result of filing for and operating under Chapter 11 protection; the time, terms and ability to confirm a sale of the Company's businesses under Section 363 of the U.S. Bankruptcy Code; the adequacy of the capital resources of the Company's businesses and the difficulty in forecasting the liquidity requirements of the operations of the Company's businesses; the unpredictability of the Company's financial results while in Chapter 11 proceedings; the Company's ability to discharge claims in Chapter 11 proceedings; negotiations with the holders of the Company's indebtedness and its trade creditors and other significant creditors; risks and uncertainties with performing under the terms of the restructuring support agreement and any other arrangement with lenders or creditors while in Chapter 11 proceedings; the Company's ability to conduct business as usual; the Company's ability to continue to serve customers, suppliers and other business partners at the high level of service and performance they have come to expect from the Company; the Company's ability to continue to pay employees, suppliers and vendors; the ability to control costs during Chapter 11 proceedings; adverse litigation; the risk that the Company's Chapter 11 Cases may be converted to cases under Chapter 7 of the Bankruptcy Code; the Company's ability to secure operating capital; the Company's ability to take advantage of opportunities to acquire assets with upside potential; the Company's ability to execute on its strategic plan to pursue, evaluate and close an asset sale of the Company's businesses pursuant to Section 363 of the U.S. Bankruptcy Code; the impact of competition and the timing of competitive entrants; Endo's ability to satisfy judgments or settlements or pursue appeals including bonding requirements; Endo's ability to adjust to changing market conditions; Endo's ability to attract and retain key personnel; supply chain interruptions or difficulties; changes in competitive or market conditions; changes in legislation or regulatory developments; Endo's ability to obtain and maintain adequate protection for Endo's intellectual property rights; the timing and uncertainty of the results of both the research and development and regulatory processes, including regulatory decisions, product recalls, withdrawals and other unusual items; domestic and foreign health care and cost containment reforms, including government pricing, tax and reimbursement policies; technological advances and patents obtained by competitors; the performance, including the approval, introduction, and consumer and physician acceptance of new products and the continuing acceptance of currently marketed products; Endo's ability to integrate any newly acquired products into Endo's portfolio and achieve any financial or commercial expectations; the impact that known and unknown side effects may have on market perception and consumer preference for Endo's products; the effectiveness of advertising and other promotional campaigns; the timely and successful implementation of any strategic initiatives; unfavorable publicity regarding the misuse of opioids; the uncertainty associated with the identification of and successful consummation and execution of external corporate development initiatives and strategic partnering transactions; Endo's ability to advance its strategic priorities, develop its product pipeline and continue to develop the market for XIAFLEX® and other branded and unbranded products; and Endo's ability to obtain and successfully manufacture, maintain and distribute a sufficient supply of products to meet market demand in a timely manner. In addition, U.S. and international economic conditions, including consumer confidence and debt levels, inflation, taxation, changes in interest and currency exchange rates, international relations, capital and credit availability, the status of financial markets and institutions and the impact of continued economic volatility, can materially affect Endo's results. Therefore, the reader is cautioned not to rely on these forward-looking statements. Endo expressly disclaims any intent or obligation to update these forward-looking statements, except as required to do so by law. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo, as well as Endo's public periodic filings with the U.S. Securities and Exchange Commission and with securities regulators in Canada, including the discussion under the heading "Risk Factors" in Endo's most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q or other filings with the U.S. Securities and Exchange Commission. Copies of Endo's press releases and additional information about Endo are available at or you can contact the Endo Investor Relations Department at [email protected]. SOURCE Endo International plc

PARK CITY, Utah, Oct. 23, 2023 /PRNewswire/ -- Sentient, the premier, full-service aesthetic device provider and the exclusive U.S. provider of Tixel by Sentient and Sentient Sculpt®, announces the appointment of two dynamic leaders to its executive leadership team. Brian Kirk joins as Chief Marketing Officer (CMO) and Jennifer Redmond joins as Chief Revenue Officer (CRO). These strategic additions to the c-suite reflect Sentient's unwavering commitment to bringing disruptive technologies and a customer-centric approach to aesthetic medical device providers. Continue Reading Marketing Prowess to Activate Consumers and Drive Growth for Aesthetic Providers As the newly appointed CMO, Brian Kirk is charged with elevating Sentient's marketing investment to support the continued success of Tixel by Sentient and Sentient Sculpt®, while advancing the Confidence Assured® service, financing and warranty offerings. With more than two decades of experience in branding and marketing, Kirk brings a strong track record of driving results for the companies he has served. Most notably, in his role as vice president of marketing at Built Brands, LLC, he was instrumental in driving over $100 million in e-commerce revenue and attracting more than 250,000 new consumers. Sentient Welcomes Two Accomplished Executives to Fuel Growth and Innovation: Brian Kirk and Jennifer Redmond Post this At Purple Innovation, LLC, Kirk conceived and implemented a marketing and brand campaign infrastructure that garnered 5.2 billion content views and delivered a 210 percent year-over-year increase in top-line revenue. His rich history in senior marketing positions at ROKA and Skullcandy Inc. is a testament to his well-rounded expertise in building brand identities and driving growth. Kirk is charged with building a professional and lifestyle brand that embodies Sentient's commitment to helping consumers who want to look and feel their best. Seasoned Medical Aesthetics Leadership to Guide Revenue Growth Jennifer Redmond steps into the role of CRO of Sentient and will be charged with leading all revenue growth functions for the company. She brings a wealth of knowledge and diverse experience in national sales leadership, marketing and KOL relationship development from more than 18 years in medical aesthetics. Notably, as employee number two at Endo Aesthetics, Redmond played a critical role in the strategic planning and execution for the launch of Qwo®. There she built and led a highly talented and tenured team of more than 85 aesthetic sales professionals, while simultaneously earning her MBA from NYU Stern School of Business. In 2015, as the national sales director for Merz Aesthetics, Redmond led a strategic transformation of the facial injectables team, growing the business for the first time to more than $150 million. In addition, during her tenure in filler marketing, she led professional and consumer rebranding efforts that positioned Belotero® Balance dermal filler for future success. Redmond's deep relationships within the aesthetic KOL community, resulting from her time in professional relations, also will prove to be extremely valuable for Sentient. In her new role, Redmond will spearhead strategies aimed at strengthening customer relationships while identifying opportunities for revenue advancement. "We are excited to welcome Brian and Jen to our company," said Chris Cella, CEO and founder of Sentient. "In Sentient's first 14 years, we have diligently built our operations to offer industry-leading service and financial solutions, along with an exceptional suite of advanced proprietary technologies to practices of all sizes. With the addition of these two talented leaders, we are positioned to reach new heights, driving innovation, excellence and growth for aesthetics providers across America, and our support for consumers who want to look and feel their best with confidence assured." About Sentient Sentient is the leading full-service provider in the aesthetic medical device industry, offering advanced technology and industry-leading service and financing with integrity and transparency. From its Park City, Utah, headquarters to nationwide, Sentient provides an exceptional suite of advanced proprietary technologies to practices of all sizes. With longstanding professional relationships and more than 10 years of providing the best-refurbished equipment, Sentient's industry-leading service model ensures quality laser and medical device repair and refurbishment services for 84 types of medical and cosmetic systems. Committed to building collaborative relationships with clients, Sentient significantly enhances practice efficiency, drives stronger profitability, and delivers an exceptional client experience. About Tixel by Sentient Tixel by Sentient uses the first and only thermal-mechanical action technology to resurface skin. Tixel technology uniquely combines heat with the forward motion of a medical-grade titanium tip without the use of lasers, radiation, ultrasound, or needles, providing a comfortable treatment experience that creates a smoother and more even-toned appearance without social downtime. Proven on a global scale, Tixel has been used in Europe since 2011 and is now exclusively available in the United States through Sentient. Cleared by the FDA for treatment of all skin types, this proprietary, non-invasive technology transfers thermal energy to skin very quickly and safely. About Sentient Sculpt® Sentient Sculpt® is the first non-invasive professional electromagnetic wave and microwave treatment for cellulite reduction that consistently produces results on all skin types. Unlike other products on the market that are absorbed in the skin or medical devices that incise tissue, Sentient Sculpt's controlled energy elevates tissue temperature to reach all-important cellulite fibers and fat cells, while simultaneously cooling the skin. Successfully utilized in Europe over the past four years under a different trade name, it is being offered in the U.S. exclusively by Sentient. The technology behind Sentient Sculpt has been cleared by the U.S. Food and Drug Administration. Media Contact: Ivy Cohen Ivy Cohen Corporate Communications (212) 399-0026 [email protected] SOURCE Sentient