Orphan Europe SARL

Drs. Daniel C. Cattran and Fernando C. Fervenza join ZyVersa's distinguished group of Scientific Advisors VAR 200 is a phase 2a-ready cholesterol efflux mediator in development to ameliorate renal lipid accumulation that damages the kidneys' filtration system, leading to progression of kidney disease WESTON, Fla., Jan. 3, 2023 /PRNewswire/ -- ZyVersa Therapeutics, Inc. (Nasdaq: ZVSA; "ZyVersa"), a clinical stage specialty biopharmaceutical company developing first-in-class drugs for treatment of renal and inflammatory diseases, announces that two leading nephrologists have joined ZyVersa's Renal Scientific Advisory Board. Daniel C. Cattran, MD Professor of Medicine, University of Toronto Senior Scientist, Toronto General Research Institute Continue Reading Two esteemed nephrologists join ZyVersa's Renal Scientific Advisory Board, Drs. Daniel C. Cattran & Fernando C. Fervenza Tweet this (PRNewsfoto/Variant Pharmaceuticals, Inc.) Fernando C. Fervenza, MD, PhD Professor of Medicine, Mayo Graduate School of Medicine Director of the Nephrology Collaborative Group "We are honored that nephrologists with the accomplishments of Drs. Cattran and Fervenza are joining our Scientific Advisory Board," stated Dr. Pablo Guzman, ZyVersa's Chief Medical Officer, and Chairman of the Renal Scientific Advisory Board. "Their clinical and research expertise have earned them global distinction as key thought-leaders in the field of nephrology. We look forward to their invaluable contributions that will help drive the timely success of our clinical development program for our cholesterol efflux mediator, VAR 200," continued Dr. Guzman. Drs. Cattran and Fervenza join ZyVersa's current team of prominent Scientific Advisors, Sharon G. Adler, MD: Professor of Medicine at David Geffen School of Medicine, UCLA; Chief, Division of Nephrology and Hypertension at Harbor-UCLA Medical Center; and Program Director, Nephrology Fellowship Training Program at Harbor-UCLA Medical Center; Alessia Fornoni, MD, PhD: Professor of Medicine and Chief of Katz Family Division of Nephrology and Hypertension at University of Miami Miller School of Medicine; Debbie S. Gipson, MD, MS: Professor, Department of Pediatrics at University of Michigan and Director of the Kidney Research Network Coordinating Center; Marlene Haffner, MD, MPH: Principal and Founder of Orphan Solutions and former Director of Orphan Products Development at FDA; and Pablo A. Guzman, MD, FAAC: Chief Medical Officer and Chairman of Renal Scientific Advisory Board at ZyVersa Therapeutics. "Enlisting the insights and strategic guidance of our renowned scientific advisory board is key to achieving our mission to develop transformative drug therapies for patients with renal disease," said Stephen C. Glover, ZyVersa's Co-founder, Chief Executive Officer, and Chairman. "We appreciate their expertise and time to support our mission," added Mr. Glover. About VAR 200 VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a cholesterol efflux mediator in development to ameliorate renal lipid accumulation that damages the kidneys' filtration system, leading to kidney disease progression. VAR 200 passively and actively removes excess lipids from the kidney. Preclinical studies with VAR 200 in animal models of FSGS, Alport syndrome, and diabetic kidney disease demonstrate that removal of excess cholesterol and lipids from kidney podocytes protects against structural damage and reduces excretion of protein in the urine (proteinuria). The lead indication for VAR 200 is orphan kidney disease focal segmental glomerulosclerosis (FSGS). VAR 200 has potential to treat other glomerular diseases, including orphan Alport syndrome and diabetic kidney disease. About ZyVersa Therapeutics, Inc. ZyVersa is a clinical stage specialty biopharmaceutical company leveraging advanced, proprietary technologies to develop first-in-class drugs. Our focus is on patients with renal or inflammatory diseases who have significant unmet medical needs. Our development pipeline includes phase 2a-ready VAR 200, a cholesterol efflux mediator in development to alleviate damaging accumulation of cholesterol and lipids in the filtering system of the kidneys. The lead indication is treatment of rare kidney disease, focal segmental glomerulosclerosis. VAR 200 has potential to treat other kidney diseases, including Alport syndrome and diabetic kidney disease. Our pipeline also includes a proprietary inflammasome ASC inhibitor that blocks initiation and perpetuation of damaging inflammation associated with a multitude of inflammatory diseases. IC 100 has potential to treat many different CNS and other inflammatory diseases. For more information, please visit . Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this press release regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These include statements regarding management's intentions, plans, beliefs, expectations, or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. ZyVersa Therapeutics, Inc ("ZyVersa") uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "continue," "guidance," and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions. Such forward-looking statements are based on ZyVersa's expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors, including ZyVersa's plans to develop and commercialize its product candidates, the timing of initiation of ZyVersa's planned preclinical and clinical trials; the timing of the availability of data from ZyVersa's preclinical and clinical trials; the timing of any planned investigational new drug application or new drug application; ZyVersa's plans to research, develop, and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of ZyVersa's product candidates; ZyVersa's commercialization, marketing and manufacturing capabilities and strategy; ZyVersa's ability to protect its intellectual property position; and ZyVersa's estimates regarding future revenue, expenses, capital requirements and need for additional financing. New factors emerge from time-to-time, and it is not possible for ZyVersa to predict all such factors, nor can ZyVersa assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements included in this press release are based on information available to ZyVersa as of the date of this press release. ZyVersa disclaims any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except as required by applicable law. This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any securities. SOURCE ZyVersa Therapeutics, Inc.

RECORDATI ANNOUNCES SALES AND MARGIN GROWTH IN THE FIRST NINE MONTHS 2018. REVENUES +5.1%, EBITDA +11.1%, OPERATING INCOME +9.6%, NET INCOME +8.2%. INTERIM DIVIDEND € 0.45 (+7.1%). Consolidated revenues € 1,013.3 million, +5.1%.EBITDA (1) € 380.1 million, +11.1%Operating income € 337.0 million, +9.6%.Net income € 237.9 million, +8.2%.Net financial position (2):  net debt of € 462.7 million.Shareholders’ equity € 988.0 million.Interim 2018 dividend of € 0.45 per share to be distributed. Milan, 30 October 2018 – The Board of Directors of Recordati S.p.A. approved the Group’s consolidated results for the first nine months of 2018 prepared in accordance with International Accounting Standards and International Financial Reporting Standards (IAS/IFRS) and in particular as per IAS 34 requirements for interim reporting. These financial statements will be available today at the company’s offices and on the company’s website www.recordati.com and can also be viewed on the authorized storage system 1Info (www.1Info.it). Financial highlights Consolidated revenues in the first nine months of 2018 are € 1,013.3 million, up by 5.1% compared to the same period of the preceding year. International sales grow by 5.4%. EBITDA (1), at 37.5% of sales, is € 380.1 million, an increase of 11.1% over the same period of the preceding year. Operating income, at 33.3% of sales, is € 337.0 million, an increase of 9.6%.  Net income, at 23.5% of sales, is € 237.9 million, an increase of 8.2% over the first nine months of 2018. Net financial position (2) at 30 September 2018 records a net debt of € 462.7 million compared to net debt of € 381.8 million at 31 December 2017. During the period own shares were purchased for an overall disbursement of € 169.8 million, dividends were distributed for an amount of € 87.1 million. Furthermore, the Italian company Natural Point S.r.l. was acquired for a value of € 75 million. Shareholders’ equity is € 988.0 million.               (1) Operating income before depreciation, amortization and write down of both tangible and intangible assets.(2) Cash and short-term financial investments less bank overdrafts and medium/long-term loans which include the measurement at fair value of hedging derivatives. Corporate development news In April an agreement with Mylan for the acquisition of the rights to Cystagon® (cysteamine bitartrate), indicated for the treatment of proven nephropathic cystinosis in children and adults, for certain territories, including Europe, was concluded. The product was previously commercialized by Orphan Europe (a Recordati group company) under license from Mylan. The definitive acquisition of the rights allows the Group to continue offering this life-saving treatment to patients. In June Recordati acquired 100% of the share capital of Natural Point S.r.l., an Italian company, based in Milan, active in the food supplements market. The company realized sales of € 15 million in 2017 and has an excellent profitability profile. The signing and closing of the transaction took place at the same time. Natural Point was established in 1993 with the objective of promoting a culture of healthy use of food supplements. It offers a wide portfolio of very efficacious supplements in highly bioavailable formulations, produced with safe active ingredients, to improve health and well-being. The company’s main product is a particular formulation of magnesium carbonate and citric acid that has the characteristic of being easily assimilated into the body, apart from its having an agreeable flavor. Management Comments “The financial results obtained in the first nine months of the year confirm the continued growth of the Group, with further improvement of its profitability”, declared Andrea Recordati, CEO. “During the year important initiatives were concluded. The definitive acquisition of the rights to Cystagon® from Mylan allows us to ensure the continued availability of this life-saving treatment to patients and the acquisition of Natural Point represents a good opportunity to enhance our presence in the market for food supplements. Furthermore, during the last quarter, Reagila®, a new drug for the treatment of schizophrenia, will be launched in some European countries”, continued Andrea Recordati. “The growth of Group’s business continued during October. Taking into account the strong devaluation of the Turkish lira, which we estimate will have, on its own, an impact of around € 30 million for the full year, we expect for the whole of 2018 to achieve sales ranging from € 1,340 million to € 1,350 million, whilst we confirm our objectives for EBITDA of between € 490 and € 500 million, EBIT of between € 430 and € 440 million and net income of between € 310 and € 315 million.” Further resolutions 2018 Interim dividend The Board of Directors resolved to distribute an interim dividend relating to the financial year 2018 amounting to € 0.45 (before withholding tax) on each outstanding share, excluding shares in treasury stock. The interim dividend will be paid, through the authorised intermediaries, as from November 21, 2018 (record date November 20, 2018) on coupon No. 22 to be presented on November 19, 2018. The Independent Auditor’s opinion on the distribution of the interim dividend is also available at the Company’s registered offices as per article 2433-bis of the Italian Civil Code. The Directors’ Report and financial statements of Recordati S.p.A. as at 30 June 2018, on which the Board of Directors based its resolution to distribute the abovementioned interim dividend, are available at the Company’s registered offices and published on the Company’s website (www.recordati.com). Such documents can also be viewed on the authorized storage system 1Info (www.1Info.it). Conference call Recordati will be hosting a conference call today 30 October 2018 at 4.00 pm Italian time (3.00 pm London time, 10.00 am New York time). The dial-in numbers are: Italy                             +39 02 8058811, toll free 800 213 858UK                                +44 1 212818003, toll free 800 0156384USA                             +1 718 7058794, toll free 855 2656959 France                        +33 170918703 Germany                   +49 69 255114451 Callers are invited to dial-in 10 minutes before conference time.  If conference operator assistance is required during the connection, please digit * followed by 0 or call +39 02 8061371.  A recording of the conference call will be placed on the website www.recordati.com. A set of slides which will be referred to during the call will be available on our website www.recordati.com under Investors/Company Presentations. Recordati, established in 1926, is an international pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of more than 4,100, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations throughout the whole of Europe, including Russia, Turkey, North Africa, the United States of America, Canada, Mexico, some South American countries, Japan and Australia.  An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new specialties with a focus on treatments for rare diseases.  Consolidated revenue for 2017 was € 1,288.1 million, operating income was € 406.5 million and net income was € 288.8 million. For further information: Recordati website:  www.recordati.com Investor Relations                                                                       Media Relations                    Marianne Tatschke                                                                     Studio Noris Morano                                                            (39)0248787393                                                                          (39)0276004736, (39)0276004745e-mail: investorelations@recordati.it                                        e-mail: norismorano@studionorismorano.com                                                                     Statements contained in this release, other than historical facts, are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company’s control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements. All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company’s activities and are not intended to indicate the advisability of administering any product in any particular instance. RECORDATI GROUPSummary of consolidated results prepared in accordance with the International Accounting Standards and International Financial Reporting Standards (IAS/IFRS)(thousands of €) INCOME STATEMENTFirst nine months 2018First nine months 2017Change %REVENUE1,013,308 963,827 5.1   Cost of sales(296,015)(287,596)2.9 GROSS PROFIT717,293 676,231 6.1   Selling expenses(250,258)(246,544)1.5   Research and development expenses(79,436)(72,145)10.1   General & administrative expenses(48,543)(48,670)(0.3)  Other income (expenses), net(2,087)(1,370)52.3 OPERATING INCOME336,969 307,502 9.6   Financial income (expenses), net(13,757)(11,753)17.1 PRE-TAX INCOME323,212 295,749 9.3   Provision for income taxes(85,335)(75,943)12.4 NET INCOME237,877 219,806 8.2 Attributable to:   Equity holders of the parent237,841 219,778 8.2 Non-controlling interests36 28 28.6  EARNINGS PER SHAREFirst nine months 2018First nine months 2017Change %Basic€1.163€1.0649.3Diluted€1.137€1.0518.2 Earnings per share (EPS) are based on average shares outstanding during each year, 204,556,132 in 2018 and 206,627,645 in 2017, net of average treasury stock which amounted to 4,569,024 shares in 2018 and to 2,497,511 shares in 2017.Diluted earnings per share is calculated taking into account stock options granted to employees. COMPOSITION OF REVENUEFirst nine months 2018First nine months 2017Change %Total revenue1,013,308963,8275.1Italy206,704198,5544.1International806,604765,2735.4 RECORDATI GROUPSummary of consolidated results prepared in accordance with the International Accounting Standards and International Financial Reporting Standards (IAS/IFRS)(thousands of €) INCOME STATEMENTThird Quarter 2018Third Quarter 2017Change %REVENUE317,254 312,959 1.4   Cost of sales(93,002)(90,854)2.4 GROSS PROFIT224,252 222,105 1.0   Selling expenses(77,465)(78,023)(0.7)  Research and development expenses(25,809)(24,993)3.3   General & administrative expenses(15,403)(14,829)3.9   Other income (expenses), net(537)44 n.s.OPERATING INCOME105,038 104,304 0.7   Financial income (expenses), net(5,299)(4,762)11.3 PRE-TAX INCOME99,739 99,542 0.2   Provision for income taxes(26,050)(26,723)(2.5)NET INCOME73,689 72,819 1.2 Attributable to:   Equity holders of the parent73,677 72,811 1.2 Non-controlling interests12 8 50.0  COMPOSITION OF REVENUEThird Quarter 2018Third Quarter 2017Change %Total revenue317,254312,9591.4 Italy60,91356,1398.5 International256,341256,820(0.2) RECORDATI GROUPSummary of consolidated results prepared in accordance with the International Accounting Standards and International Financial Reporting Standards (IAS/IFRS)(thousands of €) ASSETS30.09.201831.12.2017   Property, plant and equipment97,948103,009Intangible assets606,424540,565Goodwill545,601539,871Equity investments20,78524,171Non-current receivables6,7255,944Deferred tax assets75,61169,162TOTAL NON-CURRENT ASSETS1,353,0941,282,722   Inventories185,717179,100Trade receivables248,079244,117Other receivables26,25139,730Other current assets7,6064,836Fair value of hedging derivatives (cash flow hedge)4,1423,825Short-term financial investments, cash and cash equivalents235,165302,077TOTAL CURRENT ASSETS706,960773,685TOTAL ASSETS2,060,0542,056,407 EQUITY AND LIABILITIES30.09.2018 31.12.2017    Share capital26,141 26,141 Capital in excess of par value83,719 83,719 Treasury stock(151,311)(17,029)Hedging reserve(7,753)(5,867)Translation reserve(161,325)(124,004)Other reserves40,239 40,684 Retained earnings920,302 822,154 Net income for the period237,841 288,762 Interim dividend0 (87,470)GROUP SHAREHOLDERS’ EQUITY987,853 1,027,090 Minority interest183 147 SHAREHOLDERS’ EQUITY988,036 1,027,237    Loans due after one year568,911 612,462 Employees’ termination pay21,207 21,093 Deferred tax liabilities33,474 17,554 Other non-current liabilities2,516 2,515 TOTAL NON-CURRENT LIABILITIES626,108 653,624    Trade payables123,400 141,740 Other payables89,177 82,779 Tax liabilities45,075 24,373 Other current liabilities1,272 486 Provisions51,872 48,322 Fair value of hedging derivatives (cash flow hedge)8,004 9,559 Loans due within one year59,530 51,710 Bank overdrafts67,580 16,577 TOTAL CURRENT LIABILITIES445,910 375,546 TOTAL EQUITY AND LIABILITIES2,060,054 2,056,407  DECLARATION BY THE MANAGER RESPONSIBLE FOR PREPARING THE COMPANY’S FINANCIAL REPORTS The manager responsible for preparing the company’s financial reports Fritz Squindo declares, pursuant to paragraph 2 of Article 154-bis of the Consolidated Law on Finance, that the accounting information contained in this press release corresponds to the documental results, books and accounting records.