$TVTX
Travere Therapeutics Inc Stock $tvtx

$tvtx Overview Financials Valuation SEC Filings Company Website

2017 Q2 Form 10-Q Financial Statement

#000143853317000029 Filed on August 09, 2017

Income Statement

Concept	2017 Q2	2016 Q2
Revenue	$38.80M	$33.31M
YoY Change	16.48%	38.4%
Cost Of Revenue	$797.0K	$1.021M
YoY Change	-21.94%	60.28%
Gross Profit	$38.00M	$32.29M
YoY Change	17.69%	37.81%
Gross Profit Margin	97.95%	96.93%
Selling, General & Admin	$28.84M	$23.21M
YoY Change	24.26%	17.84%
% of Gross Profit	75.88%	71.86%
Research & Development	$19.48M	$17.68M
YoY Change	10.22%	67.33%
% of Gross Profit	51.26%	54.74%
Depreciation & Amortization	$4.440M	$3.970M
YoY Change	11.84%	5.59%
% of Gross Profit	11.68%	12.29%
Operating Expenses	$52.40M	$44.69M
YoY Change	17.25%	44.11%
Operating Profit	-$13.60M	-$11.38M
YoY Change	19.5%	63.87%
Interest Expense	-$658.0K	-$147.0K
YoY Change	347.62%	-94.97%
% of Operating Profit
Other Income/Expense, Net	-$1.556M	$9.416M
YoY Change	-116.53%	-150.71%
Pretax Income	-$15.15M	-$20.80M
YoY Change	-27.13%	-18.49%
Income Tax	-$1.925M	-$7.392M
% Of Pretax Income
Net Earnings	-$13.23M	-$13.40M
YoY Change	-1.3%	-47.49%
Net Earnings / Revenue	-34.1%	-40.24%
Basic Earnings Per Share	-$0.34	-$0.37
Diluted Earnings Per Share	-$0.34	-$0.37
COMMON SHARES
Basic Shares Outstanding	39.04M shares	36.68M shares
Diluted Shares Outstanding	39.04M shares	36.68M shares

Balance Sheet

Concept	2017 Q2	2016 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments	$296.0M	$221.5M
YoY Change	33.62%	65.8%
Cash & Equivalents	$89.27M	$21.16M
Short-Term Investments	$206.7M	$200.4M
Other Short-Term Assets	$6.000M	$11.90M
YoY Change	-49.58%	-87.82%
Inventory	$4.369M	$2.713M
Prepaid Expenses
Receivables	$13.32M	$16.57M
Other Receivables	$0.00	$47.50M
Total Short-Term Assets	$319.7M	$300.2M
YoY Change	6.5%	22.66%
LONG-TERM ASSETS
Property, Plant & Equipment	$2.540M	$381.0K
YoY Change	566.67%	-23.8%
Goodwill	$936.0K	$936.0K
YoY Change	0.0%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets	$3.628M	$1.859M
YoY Change	95.16%	-82.63%
Total Long-Term Assets	$187.5M	$233.8M
YoY Change	-19.82%	29.61%
TOTAL ASSETS
Total Short-Term Assets	$319.7M	$300.2M
Total Long-Term Assets	$187.5M	$233.8M
Total Assets	$507.1M	$534.0M
YoY Change	-5.03%	25.61%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable	$9.076M	$6.285M
YoY Change	44.41%	30.94%
Accrued Expenses	$27.60M	$23.16M
YoY Change	19.16%	14.08%
Deferred Revenue
YoY Change
Short-Term Debt	$0.00	$0.00
YoY Change		-100.0%
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities	$79.63M	$80.07M
YoY Change	-0.55%	-53.56%
LONG-TERM LIABILITIES
Long-Term Debt	$44.70M	$44.10M
YoY Change	1.36%	1.15%
Other Long-Term Liabilities	$3.851M	$2.548M
YoY Change	51.14%	-95.64%
Total Long-Term Liabilities	$3.851M	$2.548M
YoY Change	51.14%	-97.5%
TOTAL LIABILITIES
Total Short-Term Liabilities	$79.63M	$80.07M
Total Long-Term Liabilities	$3.851M	$2.548M
Total Liabilities	$211.3M	$219.6M
YoY Change	-3.78%	-19.97%
SHAREHOLDERS EQUITY
Retained Earnings	-$142.2M	-$67.34M
YoY Change	111.23%
Common Stock	$438.6M	$381.7M
YoY Change	14.92%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity	$295.8M	$314.4M
YoY Change
Total Liabilities & Shareholders Equity	$507.1M	$534.0M
YoY Change	-5.03%	25.61%

Cashflow Statement

Concept	2017 Q2	2016 Q2
OPERATING ACTIVITIES
Net Income	-$13.23M	-$13.40M
YoY Change	-1.3%	-47.49%
Depreciation, Depletion And Amortization	$4.440M	$3.970M
YoY Change	11.84%	5.59%
Cash From Operating Activities	$5.470M	$3.990M
YoY Change	37.09%	-49.49%
INVESTING ACTIVITIES
Capital Expenditures	-$3.010M	-$2.310M
YoY Change	30.3%	63.83%
Acquisitions
YoY Change
Other Investing Activities	$46.79M	-$1.980M
YoY Change	-2463.13%
Cash From Investing Activities	$43.76M	-$4.290M
YoY Change	-1120.05%	206.43%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities	-1.900M	-1.910M
YoY Change	-0.52%	-278.5%
NET CHANGE
Cash From Operating Activities	5.470M	3.990M
Cash From Investing Activities	43.76M	-4.290M
Cash From Financing Activities	-1.900M	-1.910M
Net Change In Cash	47.33M	-2.210M
YoY Change	-2241.63%	-129.19%
FREE CASH FLOW
Cash From Operating Activities	$5.470M	$3.990M
Capital Expenditures	-$3.010M	-$2.310M
Free Cash Flow	$8.480M	$6.300M
YoY Change	34.6%	-32.33%

Facts In Submission

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CY2016Q2	us-gaap	Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest	-20795000	USD
	us-gaap	Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest	-14649000	USD
CY2017Q2	us-gaap	Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest	-15154000	USD
	us-gaap	Income Loss From Continuing Operations Before Income Taxes Extraordinary Items Noncontrolling Interest IncomeLossFromContinuingOperationsBeforeIncomeTaxesExtraordinaryItemsNoncontrollingInterest	-28308000	USD
CY2016Q2	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-7392000	USD
CY2016Q2	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-7400000	USD
	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-12462000	USD
	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-12500000	USD
CY2017Q2	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-1925000	USD
CY2017Q2	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-1900000	USD
	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-4000000	USD
	us-gaap	Income Tax Expense Benefit IncomeTaxExpenseBenefit	-3989000	USD
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	us-gaap	Increase Decrease In Inventories IncreaseDecreaseInInventories	212000	USD
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	us-gaap	Increase Decrease In Other Operating Assets IncreaseDecreaseInOtherOperatingAssets	12000	USD
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CY2016Q2	us-gaap	Interest Income Expense Nonoperating Net InterestIncomeExpenseNonoperatingNet	-147000	USD
	us-gaap	Interest Income Expense Nonoperating Net InterestIncomeExpenseNonoperatingNet	-309000	USD
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	us-gaap	Interest Income Expense Nonoperating Net InterestIncomeExpenseNonoperatingNet	-790000	USD
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CY2016Q2	us-gaap	Net Income Loss NetIncomeLoss	-13403000	USD
	us-gaap	Net Income Loss NetIncomeLoss	-2187000	USD
	us-gaap	Net Income Loss Attributable To Parent Diluted NetIncomeLossAttributableToParentDiluted	-24319000	USD
CY2016Q2	us-gaap	Nonoperating Income Expense NonoperatingIncomeExpense	-9416000	USD
	us-gaap	Nonoperating Income Expense NonoperatingIncomeExpense	4972000	USD
CY2017Q2	us-gaap	Nonoperating Income Expense NonoperatingIncomeExpense	-1556000	USD
	us-gaap	Nonoperating Income Expense NonoperatingIncomeExpense	-302000	USD
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CY2017Q2	us-gaap	Notes And Loans Receivable Net Current NotesAndLoansReceivableNetCurrent	0	USD
CY2016Q2	us-gaap	Operating Expenses OperatingExpenses	44690000	USD
	us-gaap	Operating Expenses OperatingExpenses	81940000	USD
CY2017Q2	us-gaap	Operating Expenses OperatingExpenses	52398000	USD
	us-gaap	Operating Expenses OperatingExpenses	100426000	USD
CY2016Q2	us-gaap	Operating Income Loss OperatingIncomeLoss	-11379000	USD
	us-gaap	Operating Income Loss OperatingIncomeLoss	-19621000	USD
CY2017Q2	us-gaap	Operating Income Loss OperatingIncomeLoss	-13598000	USD
	us-gaap	Operating Income Loss OperatingIncomeLoss	-28006000	USD
CY2017Q2	us-gaap	Operating Leases Future Minimum Payments Due OperatingLeasesFutureMinimumPaymentsDue	10154000	USD
CY2017Q2	us-gaap	Operating Leases Future Minimum Payments Due In Rolling After Year Five OperatingLeasesFutureMinimumPaymentsDueInRollingAfterYearFive	806000	USD
CY2017Q2	us-gaap	Operating Leases Future Minimum Payments Due In Rolling Year Four And Five OperatingLeasesFutureMinimumPaymentsDueInRollingYearFourAndFive	4520000	USD
CY2017Q2	us-gaap	Operating Leases Future Minimum Payments Due In Rolling Year Two And Three OperatingLeasesFutureMinimumPaymentsDueInRollingYearTwoAndThree	2620000	USD
CY2017Q2	us-gaap	Operating Leases Future Minimum Payments Next Rolling Twelve Months OperatingLeasesFutureMinimumPaymentsNextRollingTwelveMonths	2208000	USD
	us-gaap	Payment For Contingent Consideration Liability Financing Activities PaymentForContingentConsiderationLiabilityFinancingActivities	2769000	USD
	us-gaap	Payment For Contingent Consideration Liability Financing Activities PaymentForContingentConsiderationLiabilityFinancingActivities	3254000	USD
	us-gaap	Payments To Acquire Available For Sale Securities PaymentsToAcquireAvailableForSaleSecurities	68517000	USD
CY2017Q2	us-gaap	Preferred Stock Shares Issued PreferredStockSharesIssued	0	shares
CY2016Q4	us-gaap	Preferred Stock Shares Outstanding PreferredStockSharesOutstanding	0	shares
	us-gaap	Payments To Acquire Available For Sale Securities PaymentsToAcquireAvailableForSaleSecurities	36213000	USD
CY2017Q2	us-gaap	Preferred Stock Shares Outstanding PreferredStockSharesOutstanding	0	shares
CY2016Q4	us-gaap	Other Assets Noncurrent OtherAssetsNoncurrent	7364000	USD
CY2017Q2	us-gaap	Other Assets Noncurrent OtherAssetsNoncurrent	3628000	USD
CY2016Q2	us-gaap	Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent	-157000	USD
	us-gaap	Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent	-706000	USD
CY2017Q2	us-gaap	Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent	27000	USD
	us-gaap	Other Comprehensive Income Availableforsale Securities Adjustment Net Of Tax Portion Attributable To Parent OtherComprehensiveIncomeAvailableforsaleSecuritiesAdjustmentNetOfTaxPortionAttributableToParent	173000	USD
CY2016Q4	us-gaap	Other Liabilities Current OtherLiabilitiesCurrent	1842000	USD
CY2017Q2	us-gaap	Other Liabilities Current OtherLiabilitiesCurrent	1593000	USD
CY2016Q4	us-gaap	Other Liabilities Noncurrent OtherLiabilitiesNoncurrent	4010000	USD
CY2017Q2	us-gaap	Other Liabilities Noncurrent OtherLiabilitiesNoncurrent	3851000	USD
	us-gaap	Other Noncash Income Expense OtherNoncashIncomeExpense	0	USD
	us-gaap	Other Noncash Income Expense OtherNoncashIncomeExpense	-260000	USD
CY2016Q2	us-gaap	Other Nonoperating Income Expense OtherNonoperatingIncomeExpense	-206000	USD
	us-gaap	Other Nonoperating Income Expense OtherNonoperatingIncomeExpense	4000	USD
CY2017Q2	us-gaap	Other Nonoperating Income Expense OtherNonoperatingIncomeExpense	382000	USD
	us-gaap	Other Nonoperating Income Expense OtherNonoperatingIncomeExpense	508000	USD
	us-gaap	Payments To Acquire Businesses Net Of Cash Acquired PaymentsToAcquireBusinessesNetOfCashAcquired	500000	USD
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	us-gaap	Payments To Acquire Intangible Assets PaymentsToAcquireIntangibleAssets	4881000	USD
	us-gaap	Payments To Acquire Intangible Assets PaymentsToAcquireIntangibleAssets	6278000	USD
	us-gaap	Payments To Acquire Property Plant And Equipment PaymentsToAcquirePropertyPlantAndEquipment	24000	USD
	us-gaap	Payments To Acquire Property Plant And Equipment PaymentsToAcquirePropertyPlantAndEquipment	1056000	USD
CY2016Q4	us-gaap	Preferred Stock Par Or Stated Value Per Share PreferredStockParOrStatedValuePerShare	0.001
CY2017Q2	us-gaap	Preferred Stock Par Or Stated Value Per Share PreferredStockParOrStatedValuePerShare	0.001
CY2016Q4	us-gaap	Preferred Stock Shares Authorized PreferredStockSharesAuthorized	20000000	shares
CY2017Q2	us-gaap	Preferred Stock Shares Authorized PreferredStockSharesAuthorized	20000000	shares
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CY2017Q2	us-gaap	Prepaid Taxes PrepaidTaxes	3644000	USD
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CY2017Q2	us-gaap	Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Weighted Average Exercise Price ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableWeightedAverageExercisePrice	15.24
CY2016Q4	us-gaap	Stockholders Equity StockholdersEquity	307767000	USD
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CY2016Q4	us-gaap	Property Plant And Equipment Net PropertyPlantAndEquipmentNet	2587000	USD
CY2017Q2	us-gaap	Property Plant And Equipment Net PropertyPlantAndEquipmentNet	2540000	USD
	us-gaap	Provision For Doubtful Accounts ProvisionForDoubtfulAccounts	49000	USD
	us-gaap	Provision For Doubtful Accounts ProvisionForDoubtfulAccounts	410000	USD
CY2017Q2	us-gaap	Purchase Obligation PurchaseObligation	681000	USD
	us-gaap	Repayments Of Other Debt RepaymentsOfOtherDebt	500000	USD
	us-gaap	Repayments Of Other Debt RepaymentsOfOtherDebt	500000	USD
CY2016Q2	us-gaap	Research And Development Expense ResearchAndDevelopmentExpense	17675000	USD
	us-gaap	Research And Development Expense ResearchAndDevelopmentExpense	32347000	USD
CY2017Q2	us-gaap	Research And Development Expense ResearchAndDevelopmentExpense	19482000	USD
CY2017Q2	us-gaap	Retained Earnings Accumulated Deficit RetainedEarningsAccumulatedDeficit	-142243000	USD
CY2016Q2	us-gaap	Sales Revenue Goods Net SalesRevenueGoodsNet	33311000	USD
	us-gaap	Sales Revenue Goods Net SalesRevenueGoodsNet	62319000	USD
CY2017Q2	us-gaap	Sales Revenue Goods Net SalesRevenueGoodsNet	38800000	USD
	us-gaap	Sales Revenue Goods Net SalesRevenueGoodsNet	72420000	USD
CY2016Q2	us-gaap	Selling General And Administrative Expense SellingGeneralAndAdministrativeExpense	23205000	USD
	us-gaap	Selling General And Administrative Expense SellingGeneralAndAdministrativeExpense	42330000	USD
CY2017Q2	us-gaap	Selling General And Administrative Expense SellingGeneralAndAdministrativeExpense	28835000	USD
	us-gaap	Selling General And Administrative Expense SellingGeneralAndAdministrativeExpense	51950000	USD
	us-gaap	Share Based Compensation ShareBasedCompensation	14286000	USD
	us-gaap	Share Based Compensation ShareBasedCompensation	14332000	USD
CY2017Q2	us-gaap	Share Based Compensation Arrangement By Share Based Payment Award Options Exercisable Number ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsExercisableNumber	4200000	shares
CY2017Q2	us-gaap	Unrecognized Tax Benefits UnrecognizedTaxBenefits	1500000	USD
CY2017Q2	us-gaap	Unrecognized Tax Benefits Income Tax Penalties And Interest Expense UnrecognizedTaxBenefitsIncomeTaxPenaltiesAndInterestExpense	0	USD
CY2016Q2	us-gaap	Weighted Average Number Of Diluted Shares Outstanding WeightedAverageNumberOfDilutedSharesOutstanding	36683429	shares
	us-gaap	Weighted Average Number Of Diluted Shares Outstanding WeightedAverageNumberOfDilutedSharesOutstanding	38063285	shares
CY2017Q2	us-gaap	Weighted Average Number Of Diluted Shares Outstanding WeightedAverageNumberOfDilutedSharesOutstanding	39041145	shares
	us-gaap	Weighted Average Number Of Diluted Shares Outstanding WeightedAverageNumberOfDilutedSharesOutstanding	38545982	shares
CY2016Q2	us-gaap	Weighted Average Number Of Shares Outstanding Basic WeightedAverageNumberOfSharesOutstandingBasic	36683429	shares
	us-gaap	Weighted Average Number Of Shares Outstanding Basic WeightedAverageNumberOfSharesOutstandingBasic	36601807	shares
CY2017Q2	us-gaap	Weighted Average Number Of Shares Outstanding Basic WeightedAverageNumberOfSharesOutstandingBasic	39041145	shares
	us-gaap	Weighted Average Number Of Shares Outstanding Basic WeightedAverageNumberOfSharesOutstandingBasic	38545982	shares
	us-gaap	Basis Of Accounting BasisOfAccounting	<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-bottom:13px;padding-top:12px;font-size:13pt;"><font style="font-family:Arial;font-size:13pt;color:#000000;font-style:normal;font-weight:bold;text-decoration:none;">BASIS OF PRESENTATION</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">December 31, 2016</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (the “2016 10-K”) filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2017. The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information, the instructions for Form 10-Q and the rules and regulations of the SEC. Accordingly, since they are interim statements, the accompanying condensed consolidated financial statements do not include all of the information and notes required by GAAP for annual financial statements, but reflect all adjustments consisting of normal, recurring adjustments, that are necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods presented. Interim results are not necessarily indicative of the results that may be expected for any future periods. The </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">December 31, 2016</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> balance sheet information was derived from the audited financial statements as of that date.</font></div></div>
	us-gaap	Nature Of Operations NatureOfOperations	<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-bottom:13px;padding-top:12px;font-size:13pt;"><font style="font-family:Arial;font-size:13pt;color:#000000;font-style:normal;font-weight:bold;text-decoration:none;">DESCRIPTION OF BUSINESS</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:16px;font-size:12pt;"><font style="font-family:Arial;font-size:12pt;color:#006ebf;font-style:normal;font-weight:bold;text-decoration:none;">Organization and Description of Business</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">In this Quarterly Report on Form 10-Q, unless the context requires otherwise, the terms “we”, “our”, “us”, “Retrophin” and the “Company” refer to Retrophin, Inc., a Delaware corporation, as well as our direct and indirect subsidiaries. Retrophin is a fully integrated biopharmaceutical company headquartered in San Diego, California focused on the development, acquisition and commercialization of therapies for the treatment of serious or rare diseases. We regularly evaluate and, where appropriate, act on opportunities to expand our product pipeline through licenses and acquisitions of products in areas that will serve patients with serious or rare diseases and that we believe offer attractive growth characteristics. </font></div><div style="line-height:120%;padding-bottom:8px;padding-top:12px;font-size:10.5pt;"><font style="font-family:Arial;font-size:10.5pt;color:#666666;font-style:italic;font-weight:bold;text-decoration:none;">Research and Development Programs:</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Fosmetpantotenate, also known as RE-024, a novel small molecule, is being developed as a potential treatment for pantothenate kinase-associated neurodegeneration (“PKAN”). PKAN is a genetic neurodegenerative disorder that is typically diagnosed in the first decade of life. Consequences of PKAN include parkinsonism, dystonia, and other severe systemic manifestations. Fosmetpantotenate (RE-024) is a phosphopantothenate replacement therapy that aims to restore levels of this key substrate in PKAN patients. Certain international health regulators have approved the initiation of dosing fosmetpantotenate (RE-024) in PKAN patients under physician-initiated studies in accordance with local regulations in their respective countries. The Company filed a U.S. Investigational New Drug ("IND") for fosmetpantotenate (RE-024) with the FDA in the first quarter of 2015 to support the commencement of a Company-sponsored Phase 1 study, which was successfully completed during 2015. The FDA granted fosmetpantotenate (RE-024) orphan drug designation in May 2015 and fast track designation in June 2015. In February 2016, the Company announced fosmetpantotenate (RE-024) was granted orphan drug designation by the European Commission. In November 2016, the Company announced that it had reached an agreement with the FDA under the Special Protocol Assessment (SPA) process for a Phase 3 clinical trial evaluating fosmetpantotenate (RE-024) for PKAN. The Company </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">has reviewed the study design with the </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> European Medicines Agency ("EMA") </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">and we expect it to support registration in Europe.</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> In July 2017, we</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> announced that the first patient had been dosed in the FORT (FOsmetpantotenate Replacement Therapy) Study.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;text-align:left;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Sparsentan, also known as RE-021, is an investigational therapeutic agent which acts as both a potent angiotensin receptor blocker (“ARB”), as well as a selective endothelin receptor antagonist (“ERA”), with in vitro selectivity toward endothelin receptor type A. The Company has secured a license to sparsentan from Ligand Pharmaceuticals, Inc. and Bristol-Myers Squibb Company (who referred to it as DARA). The Company is developing sparsentan as a treatment for focal segmental glomerulosclerosis ("FSGS"), which is a leading cause of end-stage renal disease and nephrotic syndrome (“NS”). Sparsentan was granted orphan drug designation in the United States and the European Union in January 2015 and November 2015, respectively. In the third quarter of 2016, the Company announced positive top-line data from the Phase 2 DUET study of sparsentan for the treatment of FSGS. In early 2017, we had</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;font-weight:bold;"> </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">an End of Phase 2 meeting with the U.S. Food and Drug Administration (the "FDA") regarding the regulatory pathway for sparsentan as a treatment for FSGS.  Following the meeting and our receipt of confirmatory meeting minutes, we announced our plans to initiate a single Phase 3 clinical trial to serve as the basis of a New Drug Application ("NDA") filing for sparsentan for the treatment of FSGS. </font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">We have completed the protocol design for the study and expect to gain alignment with the FDA in the second half of 2017 and initiate the trial thereafter.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Liquid ursodeoxycholic acid ("L-UDCA") is a liquid formulation of ursodeoxycholic acid being developed for the treatment of a rare liver disease called primary biliary cholangitis ("PBC"). We obtained rights to L-UDCA during 2016 with the intention of making L-UDCA commercially available to the subset of PBC patients who have difficulty swallowing. </font></div><div style="line-height:120%;padding-bottom:8px;padding-top:8px;font-size:10pt;"><font style="font-family:Arial Narrow;font-size:10pt;color:#006ebf;font-style:normal;font-weight:bold;text-decoration:none;">NGLY1 Deficiency Discovery Efforts</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:4px;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">We have entered into a research collaboration aimed at the discovery of a novel therapeutic for patients with NGLY1 deficiency, a rare genetic disorder. NGLY1 deficiency is believed to be caused by a deficiency in an enzyme called N-glycanase-1, which is encoded by the gene NGLY1. The condition is characterized by a variety of symptoms, including global developmental delay, movement disorder, seizures, and ocular abnormalities.</font></div><div style="line-height:120%;padding-bottom:8px;padding-top:12px;text-align:justify;font-size:10.5pt;"><font style="font-family:Arial;font-size:10.5pt;color:#666666;font-style:italic;font-weight:bold;text-decoration:none;">Products on the Market:</font></div><table cellpadding="0" cellspacing="0" style="padding-top:4px;padding-bottom:8px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:48px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:9.5pt;padding-left:24px;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">•</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Chenodal</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"><sup style="vertical-align:top;line-height:120%;font-size:pt">®</sup></font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (chenodiol) is approved in the United States for the treatment of patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age. Chenodal has been the standard of care for cerebrotendinous xanthomatosis ("CTX") patients for more than three decades and the Company is currently pursuing adding this indication to the label.</font></div></td></tr></table><table cellpadding="0" cellspacing="0" style="padding-top:4px;padding-bottom:8px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:48px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:9.5pt;padding-left:24px;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">•</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Cholbam</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"><sup style="vertical-align:top;line-height:120%;font-size:pt">®</sup></font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (cholic acid) is approved in the United States for the treatment of bile acid synthesis disorders due to single enzyme defects and is further indicated for adjunctive treatment of patients with peroxisomal disorders.</font></div></td></tr></table><table cellpadding="0" cellspacing="0" style="padding-top:4px;padding-bottom:8px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:48px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:9.5pt;padding-left:24px;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">•</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:justify;font-size:9.5pt;"><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;">Thiola</font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"><sup style="vertical-align:top;line-height:120%;font-size:pt">®</sup></font><font style="font-family:Arial Narrow;font-size:9.5pt;color:#000000;"> (tiopronin) is approved in the United States for the prevention of cystine (kidney) stone formation in patients with severe homozygous cystinuria.</font></div></td></tr></table></div>

Files In Submission

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0001438533-17-000029-index.html	Edgar Link	pending
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ex06302017311.htm	Edgar Link	pending
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report.css	Edgar Link	pending
rtrx-20170630.xml	Edgar Link	completed
rtrx-20170630.xsd	Edgar Link	pending
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rtrx-20170630_lab.xml	Edgar Link	unprocessable
rtrx-20170630_pre.xml	Edgar Link	unprocessable
Show.js	Edgar Link	pending

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