Adds FDA-Approved Product to Kidney and Rare Disease Portfolios
Increases Financial Guidance
Management to Host Conference Call and Webcast Tomorrow at
Thiola® is approved by the
"Thiola adds another commercial product to our portfolio and is a strategic fit with our focus on rare diseases, particularly renal disease," said
Financial Guidance
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* See note below, "Use of Non-GAAP Financial Measures."
Conference Call Information
Use of Non-GAAP Financial Measures
Non-GAAP Earnings per Share
This press release contains non-GAAP measures, including non-GAAP projected earnings and related projected earnings per share information. These measures are adjusted to exclude certain projected costs, expenses and other specified items. The adjustments to GAAP also exclude transaction related expenses, as well as non-cash items such as stock compensation, depreciation and amortization, non-cash interest expense, and other non-cash adjustments such as the increase or decrease in the fair value of derivative liabilities associated with the Company's warrants. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred.
Earnings Power per Share
This press release also refers to projected earnings power per share. This measure reflects non-GAAP projected earnings per share adjusted to exclude certain projected expenses, including research and development expenses, public company related expenses, interest expense and taxes on projected earnings at the Company's anticipated effective tax rate.
We believe that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of our financial performance and projections. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of operational results and trends. In addition, these non-GAAP financial measures are among the indicators our management uses for planning and forecasting purposes and measuring our performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.
About Thiola
Thiola is indicated for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria with urinary cystine greater than 500 mg/day, who are resistant to treatment with conservative measures of high fluid intake, alkali and diet modifications, or who have adverse reactions to d-penicillamine.
Important Safety Information
Contraindications: The use of Thiola during pregnancy is contraindicated, except in those with severe cystinuria where the anticipated benefit of inhibited stone formation clearly outweighs possible hazards of treatment.
Warnings: Despite apparent lower toxicity of Thiola, Thiola may potentially cause all the serious adverse reactions reported for d-penicillamine.
Precautions: Patients should be advised of the potential development of complications and to report promptly the occurrence of any symptom or sign of them. Carcinogenesis, mutagenesis, impairment of fertility: long-term carcino-genicity studies in animals has not been performed. Use in pregnancy: Pregnancy category
Adverse Reactions: Some patients may develop drug fever, usually during the first month of therapy. Thiola treatment should be discontinued until the fever subsides. Thiola may be associated with the following adverse reactions: gastrointestinal side effects, impairment in taste and smell, dermatologic complications, hypersensitivity reactions, hematologic abnormalities, renal complications, pulmonary manifestations, and neurological complications.
Please see the full prescribing information including the complete indications and usage, contraindications, warnings, precautions and adverse reactions at thiola.com.
About
About
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect the Company's business. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's filings with the
CFO
marc@retrophin.com
or
For
DeeterUSA
drew@deeterusa.com
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