RTRX Retrophin Inc.

18.28
+0.24  (+1%)
Previous Close 18.04
Open 17.88
52 Week Low 8.98
52 Week High 21.92
Market Cap $930,560,272
Shares 50,905,923
Float 46,095,359
Enterprise Value $683,193,272
Volume 300,416
Av. Daily Volume 343,972
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Sparsentan - DUPLEX
Focal segmental glomerulosclerosis (FSGS)
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Sparsentan
IgA nephropathy
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
CNSA-001
Phenylketonuria (PKU)
Phase 2
Phase 2
Development to be discontinued - noted August 6, 2019.
Chenodal (chenodeoxycholic acid)
Cerebrotendinous xanthomatosis (CTX).
Phase 3
Phase 3
Phase 3 patients have been randomized - noted February 24, 2020.
Fosmetpantotenate
Pantothenate kinase-associated neurodegeneration (PKAN)
Phase 3
Phase 3
Phase 3 top-line data did not meet endpoints - August 22, 2019.
New formulation of Thiola (tiopronin)
Cystinuria
Approved
Approved
FDA Approval announced June 28, 2019.
Cholbam
Rare Bile Acid Synthesis Disorders
Approved
Approved
Approved Mar 18 2015

Latest News

  1. SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that the first 280 patients have been enrolled in the pivotal Phase 3 PROTECT Study evaluating the safety and efficacy of sparsentan in IgA nephropathy (IgAN). The PROTECT Study protocol provides for a pre-specified analysis to evaluate the proteinuria efficacy endpoint in at least 280 patients after 36 weeks of treatment. Successful achievement of the 36-week proteinuria endpoint is expected to support regulatory submissions for accelerated approval in the U.S. and Europe. Topline efficacy data from the 36-week proteinuria endpoint analysis are expected in the third quarter of 2021.

    "With a lack of effective and durable treatment options available…

    SAN DIEGO, Sept. 21, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that the first 280 patients have been enrolled in the pivotal Phase 3 PROTECT Study evaluating the safety and efficacy of sparsentan in IgA nephropathy (IgAN). The PROTECT Study protocol provides for a pre-specified analysis to evaluate the proteinuria efficacy endpoint in at least 280 patients after 36 weeks of treatment. Successful achievement of the 36-week proteinuria endpoint is expected to support regulatory submissions for accelerated approval in the U.S. and Europe. Topline efficacy data from the 36-week proteinuria endpoint analysis are expected in the third quarter of 2021.

    "With a lack of effective and durable treatment options available for people living with IgAN, many patients progress to end-stage renal disease requiring kidney transplant or dialysis," said Noah Rosenberg, M.D., chief medical officer of Retrophin. "We believe the continued progress of our PROTECT Study reflects the unwavering dedication of patients and investigators to support the development of treatment options that could have the potential to delay transplant or dialysis. As a result of achieving this important enrollment milestone in the PROTECT Study ahead of schedule, we are positioned to report top-line data next year from both the PROTECT Study and our pivotal DUPLEX Study in FSGS."

    PROTECT is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled Phase 3 clinical trial expected to enroll approximately 380 patients with IgAN. Patients are randomized to receive either sparsentan or irbesartan, the active control. The proteinuria efficacy endpoint is the change in proteinuria (urine protein-to-creatinine ratio) at Week 36 compared to baseline. Secondary efficacy endpoints include the rate of change in eGFR from the initiation of randomized treatment over 58-week and 110-week periods, as well as the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment in approximately 380 patients.

    About IgA Nephropathy

    IgA nephropathy (IgAN), also called Berger's disease, is a rare kidney disorder characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), and protein in the urine (proteinuria). Other symptoms of IgAN may include kidney pain, swelling (edema) and high blood pressure.

    IgAN is the most prevalent primary chronic glomerular disease worldwide and a leading cause of end-stage renal disease (ESRD). IgAN is estimated to affect more than 100,000 people in the U.S. and is one of the leading causes of acute nephritis in Europe and Japan. There are currently no approved treatments indicated for IgAN.

    About Sparsentan

    Sparsentan is an investigational product candidate in Phase 3 clinical development that has a dual mechanism of action combining endothelin receptor type A blockade with angiotensin receptor blockade. Retrophin is developing sparsentan for the treatment of IgAN, as well as for focal segmental glomerulosclerosis (FSGS), rare kidney disorders that often lead to ESRD. In several forms of chronic kidney disease, such as IgAN and FSGS, endothelin receptor blockade has been shown to have an additive beneficial effect on proteinuria in combination with renin-angiotensin blockade via angiotensin receptor blockade or angiotensin converting enzyme inhibitors. Sparsentan has been granted orphan drug designation for the treatment of FSGS by the FDA and European Commission.

    Retrophin is currently enrolling the pivotal Phase 3 DUPLEX Study of sparsentan for the treatment of FSGS (FSGSduplex.com), as well as the pivotal Phase 3 PROTECT Study of sparsentan for the treatment of IgAN (IgANprotect.com). Both studies contain 36-week proteinuria-based endpoints, which if achieved, are expected to support submission of a New Drug Application (NDA) under the Subpart H accelerated approval pathway in the U.S. as well as an application for Conditional Marketing Authorization (CMA) consideration in Europe. If approved for both indications, sparsentan could potentially be the first medicine approved for FSGS and IgAN.

    About Retrophin

    Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company's approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin's R&D efforts are supported by revenues from the Company's commercial products Chenodal®, Cholbam®, Thiola® and Thiola EC®.

    Retrophin.com

    Forward-Looking Statements

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. 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 include, but are not limited to, references to the Company's current expectations around timelines for reporting top-line data from the proteinuria endpoints in the DUPLEX and PROTECT studies, expectations regarding potential regulatory submissions for sparsentan under the Subpart H accelerated approval pathway in the U.S. and CMA consideration in Europe and the potential future regulatory approval of sparsentan for FSGS and IgAN. 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. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the Company's business and finances in general, success of its commercial products as well as risks and uncertainties associated with the Company's preclinical and clinical stage pipeline. Specifically, the Company faces risks associated with market acceptance of its commercial products including efficacy, safety, price, reimbursement and benefit over competing therapies. The risks and uncertainties the Company faces with respect to its preclinical and clinical stage pipeline include risk that the Company's clinical candidates will not be found to be safe or effective and that current clinical trials will not proceed as planned. Specifically, the Company faces the risk that the Phase 3 clinical trial of sparsentan in FSGS will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan as planned; risk that the Phase 3 clinical trial of sparsentan in IgAN will not demonstrate that sparsentan is safe or effective or serve as the basis for accelerated approval of sparsentan as planned; and for each of its development programs, risk associated with enrollment of clinical trials for rare diseases and risk that ongoing clinical trials may not proceed on expected timelines or may be delayed for safety, regulatory or other reasons and risk that the product candidates will not be approved for efficacy, safety, regulatory or other reasons. The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including potential generic competition with certain of the Company's products, and technological changes that may limit demand for the Company's products. The Company faces additional risks associated with the potential impacts the COVID-19 pandemic may have on its business, including, but not limited to (i) the Company's ability to continue its ongoing development activities and clinical trials, (ii) the timing of such clinical trials and the release of data from those trials, (iii) the Company's and its suppliers' ability to successfully manufacture its commercial products and product candidates, and (iv) the market for and sales of its commercial products. 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 most recent Form 10-Q, Form 10-K and other filings with the Securities and Exchange Commission.

    Contact:

    Chris Cline, CFA

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879

    Primary Logo

    View Full Article Hide Full Article
  2. SAN DIEGO, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that on September 10, 2020, the Compensation Committee of its Board of Directors granted inducement stock options to purchase an aggregate of 38,250 shares of its common stock to four new employees and granted inducement restricted stock units, or RSUs, covering an aggregate of 7,475 shares of its common stock to six new employees. These inducement stock options and inducement RSUs are subject to the terms of Retrophin's 2018 Equity Incentive Plan ("2018 Plan"), but were granted outside of the 2018 Plan and were granted as inducements material to the new employees entering into employment with Retrophin in accordance with Nasdaq Listing Rule 5635(c)(4…

    SAN DIEGO, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that on September 10, 2020, the Compensation Committee of its Board of Directors granted inducement stock options to purchase an aggregate of 38,250 shares of its common stock to four new employees and granted inducement restricted stock units, or RSUs, covering an aggregate of 7,475 shares of its common stock to six new employees. These inducement stock options and inducement RSUs are subject to the terms of Retrophin's 2018 Equity Incentive Plan ("2018 Plan"), but were granted outside of the 2018 Plan and were granted as inducements material to the new employees entering into employment with Retrophin in accordance with Nasdaq Listing Rule 5635(c)(4).

    The stock options have an exercise price of $18.46 per share, the closing price of Retrophin's common stock on the date of grant, are non-qualified stock options, have a 10-year term and vest over four years, with 25% of the shares vesting on the one-year anniversary of the grant date and the remaining 75% of the shares vesting in equal monthly installments over the following 36 months, subject to the new employee's continued service relationship with Retrophin through the applicable vesting dates.

    The RSUs vest over four years, with 25% of the shares vesting on each anniversary of the grant date, subject to the new employee's continued service relationship with Retrophin through the applicable vesting dates.

    About Retrophin

    Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company's approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin's R&D efforts are supported by revenues from the Company's commercial products Chenodal®, Cholbam®, Thiola® and Thiola EC®.

    Retrophin.com



    Contact:

    Chris Cline, CFA                                           

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879                                                  

    Primary Logo

    View Full Article Hide Full Article
  3. SAN DIEGO, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that Company management will participate in the following upcoming virtual investor conferences in August:

    William Blair Biotech Focus Conference 2020
    Date: Thursday, August 6, 2020
    Time: 3:00 p.m. ET

    Canaccord Genuity 40th Annual Growth Conference
    Date: Wednesday, August 12, 2020
    Time: 2:00 p.m. ET

    Live webcasts will be available at http://ir.retrophin.com/events and archived replays will be accessible for up to 30 days.

    About Retrophin

    Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company's approach centers on its pipeline featuring sparsentan…

    SAN DIEGO, Aug. 03, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced that Company management will participate in the following upcoming virtual investor conferences in August:

    William Blair Biotech Focus Conference 2020

    Date: Thursday, August 6, 2020

    Time: 3:00 p.m. ET

    Canaccord Genuity 40th Annual Growth Conference

    Date: Wednesday, August 12, 2020

    Time: 2:00 p.m. ET

    Live webcasts will be available at http://ir.retrophin.com/events and archived replays will be accessible for up to 30 days.

    About Retrophin

    Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company's approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin's R&D efforts are supported by revenues from the Company's commercial products Chenodal®, Cholbam®, Thiola® and Thiola EC®.

    Retrophin.com

    Contact:

    Chris Cline, CFA

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879

       

    Primary Logo

    View Full Article Hide Full Article
  4. Enrollment ahead of schedule in Phase 3 PROTECT Study of sparsentan in IgAN; topline proteinuria data from both pivotal studies in FSGS and IgAN now anticipated in 2021

    Net product sales increased eight percent to $48 million in the second quarter

    Cash & equivalents of $457 million following completion of $109 million common stock offering  

    SAN DIEGO, July 30, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today reported its second quarter 2020 financial results and provided a corporate update.

    • Topline results from the 36-week proteinuria analysis in the Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) anticipated in the first quarter of 2021
    • The Phase 3 PROTECT Study of sparsentan in IgA nephropathy…

    Enrollment ahead of schedule in Phase 3 PROTECT Study of sparsentan in IgAN; topline proteinuria data from both pivotal studies in FSGS and IgAN now anticipated in 2021

    Net product sales increased eight percent to $48 million in the second quarter

    Cash & equivalents of $457 million following completion of $109 million common stock offering  

    SAN DIEGO, July 30, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today reported its second quarter 2020 financial results and provided a corporate update.

    • Topline results from the 36-week proteinuria analysis in the Phase 3 DUPLEX Study of sparsentan in focal segmental glomerulosclerosis (FSGS) anticipated in the first quarter of 2021
    • The Phase 3 PROTECT Study of sparsentan in IgA nephropathy (IgAN) is expected to achieve enrollment of the first 280 patients in 2020; topline data from the 36-week proteinuria analysis are now anticipated in the second half of 2021
    • Net product sales for the second quarter of 2020 were $48.4 million, compared to $44.7 million for the same period in 2019
    • Cash, cash equivalents and marketable securities, as of June 30, 2020, totaled $457.4 million, including net proceeds of $108.6 million from a common stock offering

    "The needs of patients living with rare disease are greater than ever and I am proud of our organization's steadfast dedication to supporting our communities, advancing our development programs and continuing to deliver our approved products during this challenging time," said Eric Dube, Ph.D., chief executive officer of Retrophin. "While significant uncertainties remain as a result of the ongoing COVID-19 pandemic, the continued focus on our key priorities and recent increase in clinical activity puts us on course to achieve topline results from the 36-week proteinuria endpoint in both the pivotal DUPLEX and PROTECT studies of sparsentan during 2021. For the balance of 2020, we will continue to focus on achieving key enrollment milestones while maintaining high quality conduct in these studies. We are also simultaneously preparing for anticipated regulatory submissions, and building upon our existing commercial capabilities for the potential launch of sparsentan, if approved."

    Quarter Ended June 30, 2020

    Net product sales for the second quarter of 2020 were $48.4 million, compared to $44.7 million for the same period in 2019. For the six months ended June 30, 2020, net product sales were $96.2 million, compared to $84.3 million for the same period in 2019. The increase in net product sales is attributable to growth across the Company's commercial products including the launch of THIOLA EC®.

    Research and development (R&D) expenses for the second quarter of 2020 were $30.8 million, compared to $37.9 million for the same period in 2019. For the six months ended June 30, 2020, R&D expenses were $61.0 million, compared to $71.4 million for the same period in 2019. The difference is largely attributable to the discontinuation of the fosmetpantotenate development program during the fourth quarter of 2019. On a non-GAAP adjusted basis, R&D expenses were $28.2 million for the second quarter of 2020, compared to $35.8 million for the same period in 2019.

    Selling, general and administrative (SG&A) expenses for the second quarter of 2020 were $35.0 million, compared to $39.0 million for the same period in 2019. For the six months ended June 30, 2020, SG&A expenses were $68.1 million, compared to $71.6 million for the same period in 2019. The difference is largely attributable to a decrease in professional fees. On a non-GAAP adjusted basis, SG&A expenses were $25.8 million for the second quarter of 2020, compared to $30.4 million for the same period in 2019.

    Total other expense, net, for the second quarter of 2020 was $2.9 million, compared to $2.1 million for the same period in 2019. The difference is largely attributable to a reduction in interest income.

    Net loss for the second quarter of 2020 was $26.1 million, or $0.58 per basic share, compared to a net loss of $38.7 million, or $0.92 per basic share for the same period in 2019. For the six months ended June 30, 2020, net loss was $25.3 million, compared to $79.7 million for the same period in 2019. On a non-GAAP adjusted basis, net loss for the second quarter of 2020 was $9.9 million, or $0.22 per basic share, compared to a net loss of $24.5 million, or $0.58 per basic share for the same period in 2019.

    As of June 30, 2020, the Company had cash, cash equivalents and marketable securities of $457.4 million. This includes net proceeds of $108.6 million from a common stock offering completed during the second quarter of 2020.

    Program Updates

    Sparsentan

    • In March 2020, The Company achieved enrollment of the first 190 patients in the pivotal Phase 3 DUPLEX Study, a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of sparsentan in approximately 300 patients with FSGS. The DUPLEX Study protocol provides for an unblinded analysis of at least 190 patients to be performed after 36 weeks of treatment to evaluate the interim efficacy endpoint – the proportion of patients achieving a FSGS partial remission of proteinuria endpoint (FPRE), which is defined as urine protein-to-creatinine ratio (Up/C) ≤1.5 g/g and a >40 percent reduction in Up/C from baseline, at Week 36. While the confirmatory endpoint of the study is the change in slope of estimated glomerular filtration rate (eGFR) after 108 weeks of treatment, successful achievement of the interim 36-week proteinuria endpoint is expected to serve as the basis for submission of a New Drug Application (NDA) under the Subpart H accelerated approval pathway in the U.S. and Conditional Marketing Authorization (CMA) consideration in Europe. The protocol for the DUPLEX Study also provides for a sample size reassessment to support the confirmatory portion of the study. At this time, the Company continues to anticipate reporting topline efficacy data from the 36-week proteinuria endpoint analysis in the first quarter of 2021, and is monitoring the potential impact of the evolving COVID-19 pandemic in conjunction with the outcome of the planned sample size reassessment on this timing.

       
    • The PROTECT Study, a global, randomized, multicenter, double-blind, parallel-arm, active-controlled pivotal Phase 3 clinical trial evaluating the safety and efficacy of sparsentan in approximately 380 patients with IgAN, is enrolling ahead of schedule and is expected to achieve enrollment of the first 280 patients in 2020. The PROTECT Study protocol provides for an unblinded analysis of at least 280 patients to be performed after 36 weeks of treatment to evaluate the primary efficacy endpoint – the change in proteinuria (urine protein-to-creatinine ratio) at Week 36 from baseline. Successful achievement of the proteinuria endpoint is expected to support submission of an NDA under the Subpart H accelerated approval pathway in the U.S., as well as an application for CMA consideration in Europe. Secondary efficacy endpoints include the rate of change in eGFR following the initiation of randomized treatment over 58-week and 110-week periods, as well as the rate of change in eGFR over 52-week and 104-week periods following the first six weeks of randomized treatment in approximately 380 patients. At this time, the Company anticipates reporting topline efficacy data from the 36-week proteinuria endpoint analysis in the second half of 2021 and is monitoring the potential impact of the evolving COVID-19 pandemic on this timing.

    Conference Call Information

    Retrophin will host a conference call and webcast today, Thursday, July 30, 2020 at 4:30 p.m. ET to discuss company updates as well as second quarter 2020 financial results. To participate in the conference call, dial +1-855-219-9219 (U.S.) or +1-315-625-6891 (International), confirmation code 6024625 shortly before 4:30 p.m. ET. The webcast can be accessed at retrophin.com, in the Events and Presentations section, and will be archived for at least 30 days. A replay of the call will be available from 7:30 p.m. ET, July 30, 2020 to 7:30 p.m. ET, August 6, 2020. The replay number is +1 (855) 859-2056 (U.S.) or +1 (404) 537-3406 (International), confirmation code 6024625.

    Use of Non-GAAP Financial Measures

    To supplement Retrophin's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP adjusted financial measures in this press release and the accompanying tables. The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Retrophin's management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. In addition, Retrophin believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period and allows for greater transparency with respect to key financial metrics the Company uses in making operating decisions.

    Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future the Company may exclude other items, or cease to exclude items that it has historically excluded, for purposes of its non-GAAP financial measures; because of the non-standardized definitions, the non-GAAP financial measures as used by the Company in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the Company's competitors and other companies.

    As used in this press release, (i) the historical non-GAAP net income (loss) measures exclude from GAAP net income (loss), as applicable, stock-based compensation expense, amortization and depreciation expense, revaluation of acquisition related contingent consideration and income tax; (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, stock-based compensation expense, and amortization and depreciation expense; (iii) the historical non-GAAP R&D expense measures exclude from GAAP R&D expenses, as applicable, stock-based compensation expense, and depreciation and amortization expense.

    About Retrophin

    Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company's approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin's R&D efforts are supported by revenues from the Company's commercial products Chenodal®, Cholbam®, Thiola® and Thiola EC®.

    Retrophin.com

    Forward-Looking Statements

    This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. 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 include, but are not limited to, references to the Company's current expectations around timelines for top-line data from the proteinuria endpoints in the DUPLEX and PROTECT studies, the Company's ability to achieve key enrollment milestones in 2020 while maintaining high quality conduct in these studies, plans for regulatory submissions for sparsentan under the Subpart H accelerated approval pathway in the U.S. and CMA consideration in Europe, and the expected impacts on the Company's business from the COVID-19 pandemic, including expectations regarding continued enrollment and conduct of its clinical trials during the pandemic.  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. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the Company's business and finances in general, success of its commercial products as well as risks and uncertainties associated with the Company's preclinical and clinical stage pipeline. Specifically, the Company faces risks associated with market acceptance of its commercial products including efficacy, safety, price, reimbursement and benefit over competing therapies. The risks and uncertainties the Company faces with respect to its preclinical and clinical stage pipeline include risk that the Company's clinical candidates will not be found to be safe or effective and that current clinical trials will not proceed as planned. Specifically, the Company faces the risk that the DUPLEX Study will not demonstrate that sparsentan is safe or effective or serve as a basis for accelerated approval of sparsentan for FSGS as planned; risk that the PROTECT Study will not demonstrate that sparsentan is safe or effective or serve as the basis for accelerated approval of sparsentan for IgAN as planned; and for each of its development programs, risk associated with enrollment of clinical trials for rare diseases and risk that ongoing clinical trials may not proceed on expected timelines or may be delayed for safety, regulatory or other reasons and risk that the product candidates will not be approved for efficacy, safety, regulatory or other reasons. The Company faces risk that it will be unable to raise additional funding that may be required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and exclusivity periods and intellectual property rights of third parties; risks associated with regulatory interactions; and risks and uncertainties relating to competitive products, including potential generic competition with certain of the Company's products, and technological changes that may limit demand for the Company's products.  The Company faces additional risks associated with the potential impacts the COVID-19 pandemic may have on its business, including, but not limited to (i) the Company's ability to continue its ongoing development activities and clinical trials, (ii) the timing of such clinical trials and the release of data from those trials, (iii) the Company's and its suppliers' ability to successfully manufacture its commercial products and product candidates, and (iv) the market for and sales of  its commercial products.  You are cautioned not to place undue reliance on the 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 most recent Form 10-Q, Form 10-K and other filings with the Securities and Exchange Commission.

    Contact:

    Chris Cline, CFA

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879



    RETROPHIN, INC. AND SUBSIDIARIES
    CONSOLIDATED BALANCE SHEETS
    (in thousands, except share amounts)
        
     June 30, 2020 December 31, 2019
    Assets(unaudited)  
    Current assets:   
    Cash and cash equivalents$237,170    $62,436   
    Available-for-sale debt securities, at fair value (amortized cost $218,596, allowance for credit losses of $0 as of June 30, 2020; amortized cost $335,206, allowance for credit losses of $0 as of December 31, 2019)220,206    336,088   
    Accounts receivable, net14,077    18,048   
    Inventory, net6,286    6,082   
    Prepaid expenses and other current assets7,714    5,015   
    Tax receivable20,109    1,395   
    Total current assets505,562    429,064   
        
    Property and equipment, net2,930    2,891   
    Other non-current assets13,895    14,709   
    Intangible assets, net155,371    157,200   
    Goodwill936    936   
    Total assets$678,694    $604,800   
        
    Liabilities and Stockholders' Equity   
    Current liabilities:   
    Accounts payable$10,198    $26,614   
    Accrued expenses44,379    51,745   
    Other current liabilities7,356    8,590   
    Business combination-related contingent consideration8,000    8,500   
    Total current liabilities69,933    95,449   
    2025 Convertible debt210,009    204,861   
    Other non-current liabilities19,507    20,894   
    Business combination-related contingent consideration, less current portion60,600    62,400   
    Total liabilities360,049    383,604   
        
    Stockholders' Equity:   
    Preferred stock $0.0001 par value; 20,000,000 shares authorized; 0 issued and outstanding as of June 30, 2020 and December 31, 2019—    —   
    Common stock $0.0001 par value; 100,000,000 shares authorized; 50,902,874 and 43,088,921 issued and outstanding as of June 30, 2020 and December 31, 2019, respectively     
    Additional paid-in capital758,945    636,910   
    Accumulated deficit(441,704)  (416,444) 
    Accumulated other comprehensive income1,399    726   
    Total stockholders' equity318,645    221,196   
    Total liabilities and stockholders' equity$678,694    $604,800   
      
      
      
      
    RETROPHIN, INC. AND SUBSIDIARIES 
    CONSOLIDATED STATEMENTS OF OPERATIONS 
    (in thousands, except share and per share data) 
    (unaudited) 
         
     Three Months Ended June 30, Six Months Ended June 30, 
     2020 2019 2020 2019 
     (unaudited)     
    Net product sales:        
    Thiola/Thiola EC$26,857    $23,778    $52,345    $44,958    
    Bile acid products21,573    20,929    43,854    39,319    
    Total net product sales48,430    44,707    96,199    84,277    
             
    Operating expenses:        
    Cost of goods sold1,494    979    2,864    1,996    
    Research and development30,790    37,934    61,038    71,377    
    Selling, general and administrative34,971    38,970    68,110    71,639    
    Change in fair value of contingent consideration4,286    3,353    2,363    6,522    
    Write off of L-UDCA IPR&D intangible asset—    —    —    25,500    
    Write off of L-UDCA contingent consideration—    —    —    (18,000)  
    Total operating expenses71,541    81,236    134,375    159,034    
             
    Operating loss(23,111)  (36,529)  (38,176)  (74,757)  
             
    Other income (expenses), net:        
    Other income (expense), net426    125    235    (177)  
    Interest income1,316    2,589    3,291    5,408    
    Interest expense(4,634)  (4,817)  (9,521)  (9,682)  
    Total other expense, net(2,892)  (2,103)  (5,995)  (4,451)  
             
    Loss before income taxes(26,003)  (38,632)  (44,171)  (79,208)  
             
    Income tax (expense) benefit(65)  (69)  18,911    (470)  
             
    Net loss$(26,068)  $(38,701)  $(25,260)  $(79,678)  
             
    Per share data:        
    Basic and diluted net loss per common share$(0.58)  $(0.92)  $(0.57)  $(1.91)  
    Basic and diluted weighted average common shares outstanding44,763,843    41,957,860    43,943,370    41,685,599    



    RETROPHIN, INC. AND SUBSIDIARIES  
    RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION 
    (in thousands, except share and per share data) 
    (unaudited) 
             
     Three Months Ended June 30, Six Months Ended June 30, 
      2020  2019 2020 2019 
    GAAP operating loss$  (23,111)  $  (36,529)  $(38,176)  $(74,757)  
             
    R&D operating expense (30,790)   (37,934)  (61,038)  (71,377)  
             
    Stock compensation 2,332     1,896    4,458    3,566    
    Amortization & depreciation 289     288    578    574    
      Subtotal non-GAAP items 2,621     2,184    5,036    4,140    
    Non-GAAP R&D expense (28,169)   (35,750)  (56,002)  (67,237)  
             
    SG&A operating expense (34,971)   (38,970)  (68,110)  (71,639)  
             
    Stock compensation 3,622     3,852    7,406    8,702    
    Amortization & depreciation 5,542     4,740    10,908    9,355    
      Subtotal non-GAAP items 9,164     8,592    18,314    18,057    
    Non-GAAP SG&A expense (25,807)   (30,378)  (49,796)  (53,582)  
             
    Change in fair value of contingent consideration 4,286     3,353    2,363    6,522    
      Subtotal non-GAAP items 16,071     14,129    25,713    28,719    
    Non-GAAP operating loss$(7,040)  $(22,400)  $(12,463)  $(46,038)  
             
    GAAP net loss$(26,068)  $(38,701)  $(25,260)  $(79,678)  
    Non-GAAP operating loss adjustments 16,071     14,129    25,713    28,719    
    Income tax provision (benefit) 65     69    (18,911)  470    
    Non-GAAP net loss$(9,932)  $(24,503)  $(18,458)  $(50,489)  
             
    Per share data:        
    Basic and diluted net loss per common share$(0.22)  $(0.58)  $(0.42)  $(1.21)  
    Basic and diluted weighted average common shares outstanding 44,763,843     41,957,860    43,943,370    41,685,599    
             

     

    Primary Logo

    View Full Article Hide Full Article
  5. SAN DIEGO, July 16, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced it will report second quarter 2020 financial results on Thursday, July 30, 2020 after the close of the U.S. financial markets. The Company will host a conference call and webcast to discuss the financial results and provide a general business update at 4:30 p.m. ET.

    Conference Call Information

    Date:Thursday, July 30, 2020
    Time:4:30 p.m. ET
    Dial-in numbers:+1 (855) 219-9219 (U.S.) or +1 (315) 625-6891 (International)
    Confirmation code:6024625
    Live webcast:Retrophin.com in the "Events & Presentations" section of the "Investors" page

    A replay of the call will be available from 7:30 p.m. ET, July 30, 2020 to 7:30 p.m. ET, August 6, 2020. The replay number is…

    SAN DIEGO, July 16, 2020 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ:RTRX) today announced it will report second quarter 2020 financial results on Thursday, July 30, 2020 after the close of the U.S. financial markets. The Company will host a conference call and webcast to discuss the financial results and provide a general business update at 4:30 p.m. ET.

    Conference Call Information

    Date:Thursday, July 30, 2020
    Time:4:30 p.m. ET
    Dial-in numbers:+1 (855) 219-9219 (U.S.) or +1 (315) 625-6891 (International)
    Confirmation code:6024625
    Live webcast:Retrophin.com in the "Events & Presentations" section of the "Investors" page

    A replay of the call will be available from 7:30 p.m. ET, July 30, 2020 to 7:30 p.m. ET, August 6, 2020. The replay number is +1 (855) 859-2056 (U.S.) or +1 (404) 537-3406 (International), confirmation code 6024625.

    About Retrophin

    Retrophin is a biopharmaceutical company specializing in identifying, developing and delivering life-changing therapies to people living with rare disease. The Company's approach centers on its pipeline featuring sparsentan, a product candidate in late-stage development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN), rare disorders characterized by progressive scarring of the kidney often leading to end-stage renal disease. Research in additional rare diseases is also underway, including partnerships with leaders in patient advocacy and government research to identify potential therapeutics for NGLY1 deficiency and Alagille syndrome, conditions with no approved treatment options. Retrophin's R&D efforts are supported by revenues from the Company's commercial products Chenodal®, Cholbam®, Thiola® and Thiola EC®.

    Retrophin.com

    Contact:

    Chris Cline, CFA                                           

    Senior Vice President, Investor Relations & Corporate Communications

    888-969-7879                                                 

    Primary Logo

    View Full Article Hide Full Article
View All Retrophin Inc. News