News Article | April 18, 2017
MIAMI LAKES, FL--(Marketwired - Apr 18, 2017) - Asana Medical, Inc., ("Asana," the "Company"), a regenerative medicine company that is developing a novel treatment for Inflammatory Bowel Disease ("IBD"), including Ulcerative Colitis and Crohn's Disease, is pleased to announce that Brian W. Andersen, an experienced industry executive with a proven record of commercial excellence, has been appointed as its Chief Business Officer. Mr. Andersen brings to Asana an impressive track record in sales and marketing leadership. Over the past fifteen years, he has launched several new products and revitalized existing products; created specialty pharmacy distribution networks; and generated/executed tactical medical marketing campaigns. As a member of the Executive team, Mr. Andersen will assist with the strategic build-out of the Asana business model and market delivery options for the Company's patented non-surgical hydrogel therapy product, ECMH™, currently being developed for the treatment of IBD. Mr. Andersen will also be instrumental in developing and executing the Company's commercialization and reimbursement plans. "I am very excited to join Asana and to work with Dr. Christine V. Sapan and her Executive team, but also with Asana's distinguished roster of medical advisors," stated Mr. Andersen. "Asana's consistent approach of providing a treatment for IBD patients that repairs and regenerates the diseased tissue, allowing the clinical symptoms to improve, continues to receive support among recent literature and biomedical reports," added Mr. Andersen. Prior to joining Asana, Mr. Andersen was the General Manager and Group Vice President of the Orphan Business Unit at Horizon Pharma which he joined in September 2014, through its acquisition of Vidara Therapeutics. While at Horizon, Brian led the integration of Vidara Therapeutics into the newly created Orphan Business Unit at Horizon, as well as the integration of Hyperion Therapeutics, which Horizon bought in March of 2015. Previous to Horizon Pharma, Brian was co-founder and Vice President of Sales and Marketing at Vidara Therapeutics. At Vidara, he was responsible for the relaunch of ACTIMMUNE® for Chronic Granulomatous Disease (CGD) and severe, malignant osteoporosis (SMO), two ultra-orphan disease states. He was also responsible for all aspects of the commercialization effort, including the establishment of a specialty pharmacy distribution network; the creation of COMPASS™, a high-touch patient reimbursement and support center; creation of the marketing plan; and hiring of the sales team. Prior to Vidara, Mr. Andersen led the marketing teams at Lundbeck, Inc. (formerly Ovation) and EKR Therapeutics, where he was responsible for the successful turnaround of PANHEMATIN®, the introduction of the CARDENE® IV Ready-to-Use Bag, and led sales training teams through the launch of SABRIL®. As Regional Business Manager with PDL BioPharma/ESP Pharma, he was responsible for managing sales teams in eight states, calling on hospitals. Mr. Andersen holds a BS in biology from the University of Illinois and an MBA from Northwestern University's Kellogg School of Management. ABOUT ASANA MEDICAL, INC. Asana Medical, Inc. is an emerging life science company developing tissue engineered therapies for the treatment of Inflammatory Bowel Disease (IBD). The Company's lead therapy, a novel application of a proven technology, will be a first-in-class therapy for patients suffering from Ulcerative Colitis. This therapy will be positioned to compete in a multi-billion dollar market dominated by biologic and drug therapies that can have significant side effects. Additionally, 20-30% of patients do not benefit from these therapies and have no alternative except colon removal surgery. Asana has an experienced management team, strong patent protection, world-class advisors in business and medicine, and compelling preclinical proof-of-concept data. For more information, visit www.asanamedical.com. Keep up-to-date on all of Asana's news and developments, join our online communities:
News Article | February 27, 2017
-- Fourth-Quarter 2016 Net Sales of $310.3 Million; Up 27 Percent -- -- Fourth-Quarter 2016 Net Loss of $130.5 Million(1); Adjusted EBITDA of $136.4 Million -- -- Full-Year 2016 Operating Cash Flow of $369.5 Million; Full-Year 2016 Non-GAAP Operating Cash Flow of $452.9 Million; Year-End 2016 Cash Balance of $509.1 Million -- -- Full-Year 2017 Net Sales Guidance of $1.24 Billion to $1.29 Billion; Full-Year 2017 Adjusted EBITDA Guidance of $525 Million to $575 Million -- DUBLIN, Ireland, Feb. 27, 2017 (GLOBE NEWSWIRE) -- Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, announced its fourth-quarter and full-year 2016 financial results today and provided its full-year 2017 net sales and adjusted EBITDA guidance. “We delivered a strong fourth quarter and another exceptional year of performance driven by continued commercial execution and the completion of two transformative acquisitions that bolster our rapidly expanding rare disease business,” said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. “Our performance and continued strategic acquisitions have strengthened and diversified the Company and positioned us well to deliver on our growth objectives over the long term.” (1) The fourth-quarter and full-year 2016 net losses were primarily impacted by the impairment of in-process research and development and other wind- down costs and charges related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia and acquisition-related costs primarily related to the acquisition of Raptor Pharmaceutical Corp. (2) On Sept. 26, 2016, Horizon Pharma agreed to pay Express Scripts $65 million as part of a litigation settlement, which was recorded as a one-time reduction to GAAP net sales for the three months ended Sept. 30, 2016, in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The exclusion of the $65 million settlement from GAAP net sales is the only adjustment reflected in year-to-date 2016 non-GAAP adjusted net sales. Fourth-Quarter 2016 Financial Results Note: For additional detail and reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures, please refer to the tables at the end of this release. At 8 a.m. EST / 1 p.m. IST today, the Company will host a live conference call and webcast to review its financial and operating results and provide a general business update. The live webcast and a replay may be accessed by visiting Horizon's website at http://ir.horizon-pharma.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the conference call will be available approximately two hours after the call and accessible through one of the following telephone numbers, using the passcode below: About Horizon Pharma plc Horizon Pharma plc is a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs. The Company markets 11 medicines through its orphan, rheumatology and primary care business units. For more information, please visit www.horizonpharma.com. Follow @HZNPplc on Twitter or view careers on our LinkedIn page. Note Regarding Use of Non-GAAP Financial Measures EBITDA, or earnings before interest, taxes, depreciation and amortization, and adjusted EBITDA are used and provided by Horizon Pharma as non-GAAP financial measures. Horizon Pharma provides certain other financial measures such as non-GAAP adjusted net sales and net income, non-GAAP diluted earnings per share, non-GAAP gross profit and gross profit ratio, non-GAAP operating expenses, non-GAAP tax rate, non-GAAP operating cash flow and PROCYSBI and QUINSAIR net sales on a combined and adjusted basis, each of which include adjustments to GAAP figures. These non-GAAP measures are intended to provide additional information on Horizon Pharma’s performance, operations, expenses, profitability and cash flows. Adjustments to Horizon Pharma's GAAP figures as well as EBITDA exclude acquisition-related expenses, charges related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia, an upfront fee for a license of a patent, a litigation settlement, loss on debt extinguishment and loss on sale of long-term investments, as well as non-cash items such as share-based compensation, depreciation and amortization, royalty accretion, non-cash interest expense, intangible and other non-current asset impairment charges, and other non-cash adjustments. 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. Horizon maintains an established non-GAAP cost policy that guides the determination of what costs will be excluded in non-GAAP measures. Horizon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Horizon's financial and operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected 2017 financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators Horizon's management uses for planning and forecasting purposes and measuring the Company's performance. For example, adjusted EBITDA is used by Horizon as one measure of management performance under certain incentive compensation arrangements. 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. Horizon Pharma has not provided a reconciliation of its full-year or quarterly 2017 adjusted EBITDA outlook to an expected net income (loss) outlook because certain items such as acquisition-related expenses and share-based compensation that are a component of net income (loss) cannot be reasonably projected due to the significant impact of changes in Horizon Pharma's stock price, the variability associated with the size or timing of acquisitions and other factors. These components of net income (loss) could significantly impact Horizon Pharma’s actual net income (loss). Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to Horizon Pharma's full-year and quarterly 2017 net sales and adjusted EBITDA guidance, expected financial performance in future periods, expected timing of clinical, regulatory and commercial events, the expected launch of RAVICTI in Europe, anticipated additional clinical trials of ACTIMMUNE in cancer indications, potential market opportunity for Horizon Pharma’s medicines in approved and potential additional indications, potential growth of Horizon Pharma’s medicines and business and other statements that are not historical facts. These forward-looking statements are based on Horizon Pharma's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks that Horizon’s actual future financial and operating results may differ from its expectations or goals; Horizon Pharma’s ability to grow net sales from existing products; the availability of coverage and adequate reimbursement and pricing from government and third-party payers and risks relating to the success of Horizon Pharma’s business strategies; whether Horizon Pharma is unable to enter into additional business arrangements with pharmacy benefit managers and payers on favorable terms or at all or unable to realize the expected benefits from such arrangements; risks related to acquisition integration and achieving projected cost savings and benefits; risks associated with clinical development and regulatory approvals; risks in the ability to recruit, train and retain qualified personnel; competition, including potential generic competition; the ability to protect intellectual property and defend patents; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon Pharma operates and those risks detailed from time-to-time under the caption "Risk Factors" and elsewhere in Horizon Pharma's filings and reports with the SEC. Horizon Pharma undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information. The Company acquired Raptor Pharmaceutical Corp. on October 25, 2016, including PROCYSBI and QUINSAIR. PROCYSBI and QUINSAIR net sales for the partial fourth quarter of 2016 were $25.3 million and $1.0 million, respectively. The following tables reflect sales for full-year 2015, first, second and third quarter under Raptor Pharmaceutical Corp. ownership and partial fourth-quarter 2016 net sales of Raptor and Horizon on a combined basis. (1) Expenses, including legal and consulting fees, incurred in connection with the Company’s acquisitions of Vidara Therapeutics International Public Limited Company (“Vidara”), Hyperion Therapeutics, Inc. (“Hyperion”), Crealta Holdings LLC (“Crealta”), Raptor Pharmaceutical Corp. (“Raptor”), its agreement to acquire the worldwide rights to interferon gamma-1b and its withdrawn offer to acquire Depomed Inc. have been excluded. (2) Intangible amortization expenses are associated with the Company’s intellectual property rights, developed technology and customer relationships of ACTIMMUNE, BUPHENYL, KRYSTEXXA, LODOTRA, MIGERGOT, PENNSAID 2%, PROCYSBI, RAVICTI, RAYOS and VIMOVO. (3) Represents amortization of debt discount and deferred financing costs associated with the Company's debt. (4) Represents accretion expense associated with the ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, PROCYSBI, RAVICTI and VIMOVO royalties for the three and twelve months ended December 31, 2016, and represents accretion expense associated with the ACTIMMUNE, BUPHENYL, RAVICTI and VIMOVO royalties for the three and twelve months ended December 31, 2015. (5) In connection with the Crealta acquisition, the KRYSTEXXA and MIGERGOT inventory was stepped up in value by $144,289 and during the three months ended December 31, 2016, the Company recognized in cost of goods sold, $20,889 for step-up inventory costs related to KRYSTEXXA and MIGERGOT inventory sold. During the twelve months ended December 31, 2016, the Company recognized in cost of goods sold, $48,758 for step-up inventory costs related to KRYSTEXXA and MIGERGOT inventory sold. In connection with the Raptor acquisition, the PROCYSBI and QUINSAIR inventory was stepped up in value by $66,950 and during the three months ended December 31, 2016, the Company recognized in cost of goods sold $22,379 of step-up inventory costs related to PROCYSBI and QUINSAIR inventory sold. In connection with the Hyperion acquisition, the BUPHENYL and RAVICTI inventory was stepped up in value by $8,682 and during the three months and twelve months ended December 31, 2015, the Company recognized in cost of goods sold $860 and $8,341, respectively, of step-up inventory costs related to BUPHENYL and RAVICTI inventory sold. In connection with the Vidara acquisition, the ACTIMMUNE inventory was stepped up in value by $14,218 and during the first quarter of 2015, the Company recognized in cost of goods sold the remaining $3,154 of step-up inventory costs related to ACTIMMUNE. (6) At the time of the Company's acquisition of the rights to ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, PROCYSBI, RAVICTI and VIMOVO, the Company estimated the fair value of contingent royalties payable to third parties using an income approach under the discounted cash flow method, which included revenue projections and other assumptions the Company made to determine the fair value. If the Company significantly over-performs or underperforms against its original revenue projections or it becomes necessary to make changes to assumptions as a result of a triggering event, the Company is required to reassess the fair value of the contingent royalties payable. Any subsequent adjustment to fair value is recorded in the period such adjustment is made as either an increase or decrease to royalties payable, with a corresponding increase or decrease in cost of goods sold, in accordance with established accounting policies. During the three and twelve months ended December 31, 2016, the Company recorded a net charge of $386, to cost of goods sold to adjust the amount of the contingent royalty liabilities relating to ACTIMMUNE, KRYSTEXXA, RAVICTI and VIMOVO. During the three and twelve months ended December 31, 2015, the Company recorded a net charge of $6,874 and $21,151, respectively, to cost of goods sold to adjust the amount of the contingent royalty liabilities relating to ACTIMMUNE, RAVICTI and VIMOVO. (7) Represents share-based compensation expense associated with the Company's stock option, restricted stock unit, and performance stock unit grants to its employees and non-employees, its cash-settled long-term incentive program and its employee stock purchase plan. (8) Represents depreciation expense related to the Company’s property, equipment, software and leasehold improvements. (9) Represents a charge for the impairment of in-process R&D related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia. (10) Represents charges for wind-down costs related to the discontinuation of ACTIMMUNE development for Friedreich’s ataxia. (11) Royalties of $10,434 and $37,593 were incurred during the three and twelve months ended December 31, 2016, respectively, based on the periods’ net sales for ACTIMMUNE, BUPHENYL, KRYSTEXXA, MIGERGOT, PROCYSBI, RAVICTI and VIMOVO. Royalties of $8,944 and $29,834 were incurred during the three and twelve months ended December 31, 2015, respectively, based on the periods’ net sales for ACTIMMUNE, BUPHENYL, RAVICTI and VIMOVO. (12) Income tax adjustments on pre-tax non-GAAP adjustments represent the estimated income tax impact of each pre-tax non-GAAP adjustment based on the statutory income tax rate of the applicable jurisdictions for each non-GAAP adjustment. (13) During the three months ended September 30, 2015, the Company purchased 2,250,000 shares of common stock of Depomed, Inc. ("Depomed") representing 3.75 percent of Depomed's then outstanding common stock. The shares were acquired at a cost of $71,813. During the three months ended December 31, 2015, following the Company's decision to withdraw its offer to acquire Depomed, the Company sold all of its shares in Depomed, receiving sales proceeds of $42,781. Following this sale, the Company recognized a loss of $29,032 in the consolidated statement of comprehensive income (loss). (14) Represents an upfront fee paid for a license of a global patent. (15) On September 26, 2016, the Company agreed to pay Express Scripts $65 million as part of a litigation settlement, which was recorded as a one-time reduction to GAAP net sales for the twelve months ended December 31, 2016, in accordance with U.S. Generally Accepted Accounting Principles (GAAP). The exclusion of the $65 million settlement from GAAP net sales is the only adjustment reflected in the non-GAAP adjusted net sales for the twelve months ended December 31, 2016. (16) During the third quarter of 2016, the Company released a contingent liability of $6.9 million that was recorded as part of acquisition accounting for Crealta. (17) During the twelve months ended December 31, 2015, the Company recorded a loss on induced debt conversions of $77,624, which represented an early redemption payment of $45,366, the write-down of $21,581 in debt discount and deferred financing costs, $10,005 in additional exchange consideration to debt holders and $672 in expenses incurred in connection with the induced debt conversions. (18) Other non-GAAP income tax adjustments in the twelve months ended December 31, 2015 of $105,133 related to the release of certain valuation allowances in connection with the Hyperion acquisition.
Hyperion Therapeutics | Date: 2014-09-30
The present disclosure provides methods, systems, and instruments for the determination by a physician or medical professional whether a subject is experiencing or has recently experienced an overt HE episode and for grading overt HE episodes as well as methods, systems, instruments and tools for screening for overt HE episodes by a non-medical professional such as a caregiver. Also provided are methods of treating HE episodes and methods of monitoring HE episode treatment that incorporate these methods, systems, instruments, and tools.
Hyperion Therapeutics | Date: 2013-11-21
The present disclosure provides methods for treating hepatic encephalopathy (HE) and for optimizing and adjusting nitrogen scavenging drug dosage for subjects with HE.
Hyperion Therapeutics | Date: 2013-02-22
The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Hyperion Therapeutics | Date: 2013-12-19
The invention provides a method for determining a dose and schedule and making dose adjustments of PBA prodrugs used to treat nitrogen retention states, or ammonia accumulation disorders, by measuring urinary excretion of phenylacetylglutamine and/or total urinary nitrogen. The invention provides methods to select an appropriate dosage of a PBA prodrug based on the patients dietary protein intake, or based on previous treatments administered to the patient. The methods are applicable to selecting or modifying a dosing regimen for a subject receiving an orally administered ammonia scavenging drug.
Hyperion Therapeutics | Date: 2014-10-14
The present disclosure provides novel methods for determining an effective dosage of a PAA prodrug and for treating a UCD that incorporate body surface area and urinary PAGN concentration. The disclosure further provides novel methods for assessing compliance with PAA prodrug administration that incorporate urinary PAGN concentration, and the subjects current dosing regimen, BSA, or age. The disclosure further provides novel methods of treating a UCD in a subject in need thereof that incorporate urinary PAGN concentration, and the subjects current dosing regimen, BSA, and/or age.
News Article | April 24, 2014
U.S. biopharmaceutical company Hyperion Therapeutics said on Thursday it agreed to buy Israel's Andromeda Biotech, a developer of a new diabetes drug, in a deal that could be worth close to $600 million. Andromeda is a subsidiary of Clal Biotechnology Industries. Hyperion would make milestone payments of $120 million, the first of which would not be made until acceptance of the first marketing application filing for review in either the United States or Europe. Andromeda is developing DiaPep277, a treatment for Type I diabetes. DiaPep277 is currently undergoing a second advanced Phase III clinical study, with results expected in the first quarter of 2015. Once the drug hits annual global sales of $450 million, Hyperion would pay up to $430 million in commercial milestones. It would also pay as much as 17 percent in contingent sales for annual worldwide sales above $1.2 billion, Hyperion said. "The acquisition of Andromeda Biotech is a transformative event for Hyperion," said Donald Santel, chief executive of Hyperion. "We believe DiaPep277 has the potential to become a highly differentiated, first-in-class medicine for an orphan indication with a significant unmet need." For the full Reuters news item click here.
News Article | February 17, 2015
Hyperion Therapeutics ($HPTX), which argues it was tricked into signing a $570 million deal for an Israeli biotech, has reached a ceasefire with the seller over a diabetes drug with a checkered past. The saga began last spring when Hyperion agreed to pay Clal Biotechnology $20 million up front and up to $550 million in milestones in exchange for Andromeda Biotech, developer of a Phase III diabetes treatment called DiaPep277. Everything came unraveled by September, however, as Hyperion discovered that the drug's existing late-stage data had some major holes, accusing Andromeda staffers of tampering with trial results and taking up legal arms to get some of its cash back. Now the two have reached an agreement under which Clal will hand over $2.5 million and Hyperion will promise to complete an ongoing Phase III trial of the drug for an estimated $10.5 million. Once the study is complete, an independent committee with members from Hyperion, Clal and the Weizmann Institute of Science's Yeda will pore over its results. At that point, Clal will have the option to buy Andromeda back for $3.5 million, agreeing to fork over up to $36.5 million more in milestone payments. If the Israeli company chooses not to reacquire its former seedling, the rights to DiaPep277 will revert to Yeda. Hyperion will have sunk about $40 million into Andromeda by the time the trial concludes, and so the best case for the American biotech is a simple refund. If Clal walks away from the deal, Hyperion will have nothing to show for the months and millions expended on DiaPep277. The drug, an immune intervention treatment for the orphan indication of new-onset Type 1 diabetes, was once partnered with Teva ($TEVA) before Clal paid $72 million to reacquire exclusive rights in February. The Israeli company at the time talked up negotiations with an unnamed U.S. company that turned out to be Hyperion, whose CEO, Donald Stansel, called the Andromeda acquisition a "transformative event" upon signing the deal in April. Related Articles: Hyperion and Clal come to temporary terms over a $570M biotech boondoggle Hyperion claims it was duped by fraudulent data into $570M Andromeda buyout Hyperion bets up to $570M on diabetes biotech Andromeda
News Article | November 26, 2014
Novartis ($NVS) has washed its hands of a researcher who admitted to falsifying results in a series of published papers, promising to dig into his work at the company to determine whether the pattern continued in its own labs. As the federal Office of Research Integrity disclosed, former Vanderbilt biomedical researcher Igor Dzhura falsified figures, made up tests and duplicated computer files over a period of years, making studies look much more promising than they were. On the whole, Dzhura admitted to doctoring at least 69 images in 12 figures across 7 publications and three grant applications, according to Retraction Watch, forcing him to retract 6 papers printed by Nature Cell Biology, Journal of Physiology and others. His punishment is a three-year ban from any publicly funded research projects, and, as Retraction Watch confirmed, the loss of his position at Novartis' Boston R&D operation. All of Dzhura's admitted frauds took place during his time at Vanderbilt, before he joined Novartis in 2011, but the company has taken swift action to distance itself from him. "We have learned that Igor Dzhura included papers with fraudulent data in his application for employment at Novartis," the Swiss drugmaker told Retraction Watch in a statement. "Falsifying data is not acceptable, and we have terminated his employment with the company. We are conducting an internal review to ensure that there was not any scientific misconduct related to his research here." The issue comes amid mounting concerns about the reliability of research public and private, driven to the forefront by scandals in academia and industry. In the biotech world, Hyperion Therapeutics ($HPTX) believed it was on its way to building out a diabetes pipeline when it signed a deal worth up to $570 million for Israel's Andromeda Biotech, only to discover major data flaws it blamed on researcher malfeasance. Earlier this year, Japan's vaunted Riken Center for Developmental Biology touted the breakthrough discovery that researchers had managed to engineer therapeutically useful stem cells simply by exposing healthy adult ones to trauma and acidic conditions. But, under scrutiny, the claims began to fall apart, setting in motion a scandal that ended with the suicide of one of Riken's top scientists. Related Articles: Hyperion and Clal come to temporary terms over a $570M biotech boondoggle Japanese researcher found dead amid a swirling stem cell research scandal Bloomberg: Sun Pharma plant employees faked test results