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Gentium Reports Second Quarter Financial Results; Provides Financial and Clinical Update VILLA GUARDIA (COMO), Italy, Sep 17, 2009 (BUSINESS WIRE) -- Gentium S.p.A. (NASDAQ: GENT) today reported financial results for the second quarter ended June 30, 2009. Financial Highlights Gentium S.p.A., or the Company, reports its financial condition and operating results using U.S. Generally Accepted Accounting Principles (GAAP). The Company's financial statements are prepared using the Euro as its functional currency. On June 30, 2009, EUR 1.00 = $1.4134. For the second quarter ended June 30, 2009 compared with the prior year's second quarter: * Total revenues were EUR 2.61 million, compared with EUR 1.86 million. The increase was primarily attributable to the launch of the named-patient program for Defibrotide throughout the European and Asia-Pacific markets by IDIS Limited. * Operating costs and expenses were EUR 3.02 million, compared with EUR 6.50 million. * Research and development expenses, which are included in operating costs and expenses, were EUR 0.36 million, compared with EUR 1.76 million. Research and development expenses for second quarter 2009 and 2008 are net of EUR 0.71 million and EUR 1.14 million, respectively, of government grants in the form of a tax credit. * Operating loss was EUR 0.41 million, compared with EUR 4.63 million. * Net loss was EUR 0.49 million, compared with EUR 4.53 million. * Basic and diluted net loss per share was EUR 0.03 compared with EUR 0.30 per share. For the six months ended June 30, 2009 compared with the comparable prior-year period: * Total revenues were EUR 3.62 million, compared with EUR 4.55 million. * Operating costs and expenses were EUR 7.17 million, compared with EUR 14.03 million. Research and development expenses, which are included in operating costs and expenses, were EUR 1.81 million, compared with EUR 5.37 million. Research and development expenses for second quarter 2009 and 2008 are net of EUR 0.71 million and EUR 1.14 million, respectively, of government grants in the form of a tax credit. * Operating loss was EUR 3.55 million, compared with EUR 9.48 million. * Interest income (expense), net, was (EUR 0.07) million, compared with EUR 0.16 million. * Net loss was EUR 3.45 million, compared with EUR 10.61 million. * Basic and diluted net loss per share was EUR 0.23 compared with EUR 0.71 per share. Cash and cash equivalents were EUR 1.36 million compared with EUR 11.49 million as of December 31, 2008. In March 2009, the Company made a final installment payment of EUR 4.0 million to Crinos S.p.A related to the acquisition of marketing authorizations and trademarks for Prociclide and Noravid. Excluding the payment to Crinos, net cash used in operating activities for the six-month-period ended June 30, 2009, would have amounted to EUR 5.31 compared to EUR 8.65 million for the same period of 2008. The reduction in net cash used in operating activities between periods reflects a decrease in spending in R&D activities coupled with increased cash flows from the named-patient program. The Company also utilized Cassa Integrazione, a mechanism available to companies in Italy to temporarily lay off employees with the Italian government funding a portion of the costs of the employees during the layoff-period. The Company anticipates that its current cash will meet its operating requirements through January of 2010. However, in order for the Company to continue as a going concern beyond this point, the Company will likely need to obtain capital from external sources. Clinical Update The Company has submitted abstracts for the American Society of Hematology Conference in New Orleans, LA, December 5-8, 2009. Data was submitted for the Phase III historically controlled trial for the treatment of severe VOD and for the Phase II/III European prevention of VOD trial in pediatric stem cell patients. The results from both studies are encouraging and demonstrate strong trends in favor of the Defibrotide-treated patients in both the treatment of severe VOD and the prevention of VOD. In the treatment study, 24% of patients in the Defibrotide arm compared to 9% of patients in the historical control arm achieved complete response at 100 days (p-value = 0.015) while 38% of patients in the Defibrotide arm compared to 25% of patients in the historical control arm demonstrated survival at 100 days (p-value = 0.051). In the prevention study, a 40% reduction in incidence of VOD within 30 days after stem cell transplantation (SCT) was observed in the prophylaxis arm (Intent to Treat p-value = 0.054, Per Protocol p-value = 0.037). The Company plans to announce further data from the pediatric prevention study in the upcoming weeks. "Gentium continues to move forward with the development of Defibrotide to treat and prevent VOD, a disease for which there is currently no other viable treatment option," stated Gary Gemignani, Executive Vice President and Chief Financial Officer of Gentium S.p.A. "We believe that the results from our Phase II/III European pediatric prevention trial and the Phase III historically controlled treatment trial in the U.S. demonstrate the activity of Defibrotide that has consistently been seen in numerous investigator-sponsored studies. We have been able to extend our cash reserves through the margins generated from the named-patient program and our cost reduction measures. We look forward to working collaboratively with the Company's incoming Board of Directors as we pursue strategic financing options to provide the capital necessary to further the development of Defibrotide." Operating Results Total Product sales, net for the six-month-period ended June 30, 2009 were EUR 3.53 million compared to EUR 2.91 million for the same period in 2008, an increase of EUR 0.62 million. The increase was primarily due to the launch in April 2009 of Defibrotide via a named-patient program administered by IDIS Limited throughout the European and Asia-Pacific markets. Named-patient program gross sales for the period from April 21, 2009 through June 30, 2009 amounted to EUR 1.21 million or EUR 1.04 million net of service payments to IDIS. Through August 31, 2009, the Company has generated EUR 2.3 million in gross revenue, or EUR 2.0 million in net revenue, through the named-patient program. Sales to a related party, Sirton, for the six-month-period ended June 30, 2009 and 2008 represented 6% and 12% of the total product sales, respectively. The decrease in sales to Sirton is primarily due to the fact that the Company entered into direct sales agreements with Sirton's customers in order to mitigate the risk associated with Sirton's poor financial condition. Sales to third parties decreased to EUR 2.30 million for the six-month-period ended June 30, 2009 compared to EUR 2.36 million for the same period in 2008. The six-month-period ended June 30, 2009 did not include sales of Prociclide and Noravid (both forms of Defibrotide) due to the discontinuation of the sale of these products in the Italian market, which in the prior year period accounted for revenues of EUR 1.13 million. Other revenues, primarily cost-sharing revenues from Sigma-Tau, were EUR 0.01 million for the six-month-period ended June 30, 2009, compared to EUR 1.64 million for the same period in 2008. Fluctuation versus the prior period is primarily due to timing on the recognition of reimbursement of certain costs incurred for the Company's Phase III clinical trial of Defibrotide to treat Severe VOD. Cost of goods sold was EUR 2.00 million for the six-month-period ended June 30, 2009 compared to EUR 2.95 million for the same period in 2008. Cost of goods sold as a percentage of product sales, net was 57% for the six-month-period ended June 30, 2009 compared to 102% for the same period in 2008. The percentage decrease is primarily due to (i) higher margin on Defibrotide sold through the named-patient program, (ii) price increases in the active pharmaceutical ingredient business, and (iii) discontinuation of negative margins associated with Prociclide and Noravid. The Company has fully expensed, during the prior six-month-period, costs associated with the production of Defibrotide; therefore, costs of goods sold do not reflect the full costs of production because a portion of the active pharmaceuticals ingredients, labor and overhead costs incurred to produce Defibrotide sold through the named-patient program were previously expensed. Additionally, the higher percentage for the six-month-period ended in 2008 was primarily due to the fact that product sales to Sirton were not recognized after March 2008, due to Sirton's poor financial condition and concerns over the collectability of such receivables. The Company incurred research and development expenses of EUR 1.81 million for the six-month-period ended June 30, 2009 compared to EUR 5.37 million for the same period in 2008, which are net of EUR 0.71 million and EUR 1.14 million, respectively, of government grants in the form of a tax credit. Research and development expenses were primarily for the development of Defibrotide to treat and prevent VOD. The decrease from the comparable period in 2008 is primarily due to lower development costs related to the treatment trial as this trial has been completed. General and administrative expenses were EUR 2.76 million for the six-month-period ended June 30, 2009 compared to EUR 4.80 million for the same period in 2008. General and administrative expenses from the prior six-month-period reflect the establishment of an allowance for doubtful accounts of EUR 1.50 million which was partially released for EUR 0.34 million in 2009. The decrease in general and administrative expense is also attributable to lower payroll costs due to the temporary layoffs under the Cassa Integrazione program during the six-month period ended June 30, 2009. Foreign currency exchange gain (loss) is primarily due to re-measurement of U.S. dollar cash balances. The positive result between 2009 and 2008 is due to a more favorable exchange rate in 2009 and a lower cash balance in 2009 versus 2008. Net loss was EUR 3.45 million for the six-month-period ended June 30, 2009 compared to EUR 10.61 million for the same period in 2008. The difference was primarily due to lower research and development expenses, offset by an increase in higher margin from product sales through the named-patient program. In addition, the Company has moved forward on two key strategic initiatives. In August 2009, the Company received formal notification from the Italian Health Authority (AIFA) that the marketing authorizations for Prociclide and Noravid had been withdrawn. This move was important because it allows the Company to re-position and re-launch the VOD formulation of Defibrotide in Europe. Also, the Company has received approval from the U.S. FDA to move forward with Cost Recovery for the Treatment IND program. Under current regulations, companies are allowed to recover certain costs related to the implementation of a Treatment IND. The Company plans to launch the Cost Recovery program in the fourth quarter 2009. About VOD Veno-occlusive disease is a potentially life-threatening condition, which typically occurs as an important complication of stem cell transplantation. Certain high-dose chemo-radiation therapy regimens used as part of SCT can damage the lining cells of hepatic blood vessels and so result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs (so-called severe VOD). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the U.S. or the EU. About Gentium Gentium, S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the research, discovery and development of drugs to treat and prevent a variety of vascular diseases and conditions related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status and Fast Track Designation by the U.S. FDA to treat Severe VOD and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD. |
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| aus der Diskussion: | Gentium: Defibrotide - Orphan Drug mit Blockbusterpotential |
| Autor (Datum des Eintrages): | Neoe (17.09.09 22:32:39) |
| Beitrag: | 20 von 51 (ID:38005544) |
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