Santhera Reports Solid 2009 Interim Financial Results; Well Funded
into H2 2011
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Santhera Pharmaceuticals (SIX: SANN), a Swiss specialtypharmaceutical company focused on orphan neuromuscular diseases,announced today the results for the first half year ending June 30,2009. During the reporting period, Catena® achieved net sales of CHF0.5 million in Canada, slightly better than anticipated. Net cashburn in the first six months of 2009 was CHF 21.6 million compared toCHF 25.5 million in the first half of 2008. As of June 30, 2009,Santhera had cash and cash equivalents of CHF 53.4 million.Considering milestone (EUR 5.0 million from Takeda) and upfrontpayments (USD 8.0 million from new partner Biovail), which Santherareceived after the close of the books for the 2009 Interim Report,the pro forma cash position amounts to CHF 69.8 million.Major events of 2009 to date include* Catena® in Canada: Continued success with commercialization of first product, now approximately 40% of the expected patient population on prescription and 50 patients on drug;* Regional partnering of JP-1730/fipamezole for Dyskinesia in Parkinson's Disease: License signed with Biovail for development and commercialization in North America;* Juvantia acquisition: All rights to JP-1730/fipamezole secured through exercise of call option;* FJORD Phase IIb study with JP-1730/fipamezole: Safety and efficacy confirmed in reduction of levodopa-induced dyskinesia and additional clinically meaningful benefits observed;* DELOS Phase III study with Catena®/Sovrima®: First patient randomized in Duchenne Muscular Dystrophy triggering Takeda milestone payment;* IONIA Phase III study with Catena®/Sovrima®: Disappointing results from first pivotal trial in Friedreich's Ataxia;* Catena® Named-Patient Program: Extension into Europe signed with Takeda;* Restructuring: Resources aligned to safeguard strategic flexibility until after approvals of Catena®/Sovrima® in Friedreich's Ataxia.Financial key data(IFRS, consolidated, for half year ended 2009 2008 ChangesJune 30, in CHF thousands)Cash and cash equivalents 53,442 75,0061 nm Pro forma cash and cash equivalents* 69,752 n/a nmNet change in cash and cash equivalents -21,564 -25,540 -16%Net sales 463 0 nmGross profit 365 0 nmTotal operating expenses -24,893 -22,620 10% whereof R&D -16,876 -15,725 7%Net loss -23,407 -23,255 1%1 As of December 31, 2008 * Pro forma adjusted bymilestone and upfront payments subsequent to June 30, 2009Commenting on the operational results, Klaus Schollmeier, ChiefExecutive Officer of Santhera, said: "The positive FJORD results andthe subsequent licensing of JP-1730/fipamezole to Biovail in NorthAmerica mark the highlights of the first months of this year. Thesuccessful partnering of our second compound is a significantmilestone in the development of our Company as it moves Santhera abig step towards our goal of becoming a neuromuscular specialtypharmaceutical company with a sustainable revenue stream from ourproducts and pipeline. Importantly, this success allows us to buildSanthera on several product franchises".Commenting on the financial results, Barbara Heller, Chief FinancialOfficer of Santhera, said: "The results of the first half of 2009 arein line with our expectations. We continue our strict cash managementand initiated a restructuring program while focusing on the keyassets on the market and in development. Our sales in Canada togetherwith income from our partnerships ensure that the Company is financedwell into the second half of 2011".Solid balance sheet with a cash position of CHF 53.4 million (proforma CHF 69.8 million) at mid-year 2009As of June 30, 2009, Santhera had cash and cash equivalents ofCHF 53.4 million, reflecting a net change of CHF 21.6 million in thefirst six months of 2009 compared to CHF 25.5 million in the samereporting period of 2008, primarily as a result of strict costcontrol. Total equity at mid-year 2009 amounted to CHF 82.6 millioncompared to CHF 104.5 million as of December 31, 2008. In line withthe focus on its core activities, Santhera is targeting the spendingof its funds primarily on the continuous marketing efforts in Canada,its core assets in development Catena®/Sovrima® andJP-1730/fipamezole.Santhera's share capital was increased by the exercise of employeestock options. As of June 30, 2009, the share capital consisted of3,522,715 registered shares with a nominal value of CHF 1 each.Efficient cash management; 68% of total operating expenses allocatedto R&DIn the first six months of 2009, Santhera generated net sales ofCHF 0.5 million from the sale of Catena® in Canada and a gross profitof CHF 0.4 million. Subsequently to the half-year closing and beforethe publication of this half-year report, Santhera recognized incomefrom milestone and upfront payments of CHF 16.3 million.Operating expenses in the first half of 2009 amounted to CHF 24.9million, a 10% increase over the same period in 2008. This change isin line with expectations and mainly due to the advancement of theclinical development programs and the North American commercialoperations. The expenses in Research and Development (R&D) ofCHF 16.9 million (2008: CHF 15.7 million) reflect higher costsassociated with fully recruited clinical trials and extensionstudies. In the first six months of 2009, R&D represented 68% oftotal operating expenses. Marketing and Sales (M&S) increased toCHF 2.0 million or 8% of total operating expenses (2008: CHF 1.5million) reflecting the costs of a fully operational, yet smallcommercial organization. General and administrative expenses amountedto CHF 6.0 million or 24% of total operating expenses, includingexpenses for corporate finance and business development activities(2008: CHF 5.4 million).For the first half of 2009, Santhera reported a net loss of CHF 23.4million, almost on the same level as in 2008 (CHF 23.3 million) andin line with expectations.Focus continues on core activities; outlookSince the beginning of the second half of 2009, Santhera has receiveda total of CHF 16.3 million as milestone and upfront payments. Therandomization of the first patient into the DELOS Phase III studywith Catena®/Sovrima® in Duchenne Muscular Dystrophy triggered amilestone payment of EUR 5.0 million from Takeda PharmaceuticalCompany, marketing partner in the European Union and Switzerland.Santhera also received USD 8.0 million from Biovail Corporation asupfront fee for partnering its JP-1730/fipamezole program in NorthAmerica. As a consequence, the pro forma adjusted cash position ofSanthera as of June 30, 2009, amounts to CHF 69.8 million. A furthermilestone payment of USD 4.0 million will be due from new partnerBiovail upon the closing of the acquisition of Juvantia.In connection with its partnering activities for JP-1730/fipamezole,Santhera exercised its option to acquire Oy Juvantia Pharma Ltd, theowner of the compound, and will issue up to 105,973 previouslyreserved shares from its authorized capital to the shareholders ofJuvantia.In July, Santhera announced plans to align its resources and tocontinue the focus of its financial and human resources on theCompany's key value drivers, namely on Catena®/Sovrima® as well asJP-1730/fipamezole. The restructuring effectively results in areduction in headcount primarily in drug discovery by 23 persons.Santhera's core pharmacology and medicinal chemistry know-how inneuromuscular diseases, however, is maintained and fully operational.The Company expects total restructuring costs in the amount ofCHF 1.3 million, whereof CHF 0.5 million will be cash relevant.For the second half of 2009, Santhera anticipates to be close to cashbreak even with an expected net cash burn of approximately CHF 3.0million for the period. An average net cash burn of CHF 2.0 to2.5 million per month is expected over the planning period until endof 2010. According to this current financial planning, the Company iswell funded into the second half of 2011, i.e. beyond the potentialmarketing approvals for Catena®/Sovrima® in Friedreich's Ataxia inthe US and Europe.Update on products and pipeline: Focusing on key value drivers1. Catena®/Sovrima® in Friedreich's AtaxiaSales of Catena® in Canada continue on a steady hike. By the end ofAugust, approximately 120 patients or 40% of the expected patientpopulation of 300 individuals in Canada have received a prescriptionfrom their treating physician with an even split of private andpublic insurance coverage. Catena® has been shipped to 50 sufferers,among them a growing number of patients with public insurers.Santhera is in ongoing negotiations with public and private payors tosecure reimbursement on both national and provincial levels.In response to requests from patients and physicians, Santheraextended its Named-Patient Program (NPP) into Europe to make Catena®available on an individual basis and to bridge the time untilregulatory approval is received. The Catena® NPP is managed by Idis,a global leader in the development and implementation of suchprograms.The twelve-month MICONOS study with 232 patients enrolled is welladvanced and data from this pivotal study are expected in the firsthalf of 2010. Subject to positive outcome, Santhera intends to file aNew Drug Application for Catena® in the United States and a MarketingAuthorization Application for Sovrima® (Takeda's brand name for thedrug in Europe) in the European Union in the second half of 2010.2. Catena®/Sovrima® in Duchenne Muscular DystrophyThe first patient was recently enrolled into the pivotal DELOS study.The primary endpoint of this twelve-month, double-blind,placebo-controlled Phase III study is the change in respiratoryfunction measured by peak expiratory flow. The study is expected toenroll up to 240 ambulatory and nonambulatory patients and involve upto 25 centers in Europe and North America. Both the US Food and DrugAdministration (FDA) and the European Medicines Agency agreed that asingle pivotal study could suffice for approval.3. Catena® in Leber's Hereditary Optic NeuropathyAt the end of July, the last of 85 patients was enrolled into thesix-month Phase II RHODOS study. The Phase II study investigates theefficacy of Catena® in improving visual function in this diseasecausing rapid and complete vision loss. Data of the RHODOS study areexpected in the first half of 2010.4. Catena® in MELAS syndromeThe first patients are being randomized into the one-month MELTIMIstudy. The double-blind, placebo-controlled Phase II study is beingperformed in collaboration with the Columbia University, New York.Data of this proof-of-concept study are expected in the first half of2010. Meanwhile, the FDA granted orphan drug designation to theprogram.5. Catena® in Primary Progressive Multiple SclerosisThe US National Institutes of Health have enrolled the first patientinto the natural history phase of the IPPoMS study. The Phase I/IIstudy is conducted in collaboration with Santhera and consists of aone-year observational and a two-year interventional period.6. JP-1730/fipamezole in Dyskinesia in Parkinson's DiseaseThe recently completed FJORD Phase IIb study demonstrated thatJP-1730/fipamezole reduces Dyskinesia in Parkinson's Disease withoutexacerbating the underlying Parkinsonian features of the disease. Thestudy results also suggest that the drug has the potential to reduce"off time" and improve cognitive function. Furthermore, the reductionin dyskinesia was found to be strongly correlated with theinvestigator's clinical global impression of improvement in overall.In August, Biovail acquired the US and Canadian rights to develop andcommercialize the drug for the treatment of levodopa-inducedDyskinesia in Parkinson's Disease. Under the terms of the agreementSanthera received an upfront fee of USD 8.0 million and is entitledto another payment of USD 4.0 million upon closing the acquisition ofJuvantia and to up to USD 180.0 million in development andcommercialization milestones plus royalties on future sales of 8 to15%. Santhera retains copromotion rights in the United States. Theprocess to partner the program in other territories is ongoing.7. SNT-317/omigapil in Congenital Muscular DystrophiesDiscussions with patient organizations to support the clinicaldevelopment are well advanced. Santhera intends to reinitiateinternal and external work once the funding of the program issecured.8. Melanocortin-4 (MC4) receptor antagonists in Cancer CachexiaA potent clinical candidate with an impressive efficacy and oralbioavailability profile has been selected and is undergoing furtherpreclinical studies. Activities to partner the program with anoncology specialist for further development and commercialization areongoing.+-------------------------------------------------------------------+| Condensed income statement (unaudited) | | ||-----------------------------------------------+---------+---------|| (IFRS, consolidated, for half-year ended | | || June 30, in CHF thousands) | 2009 | 2008 ||-----------------------------------------------+---------+---------|| Net sales | 463 | 0 ||-----------------------------------------------+---------+---------|| Gross profit | 365 | 0 ||-----------------------------------------------+---------+---------|| | | ||-----------------------------------------------+---------+---------|| Research and Development | -16,876 | -15,725 ||-----------------------------------------------+---------+---------|| Marketing and Sales | -1,971 | -1,464 ||-----------------------------------------------+---------+---------|| General and Administration | -6,016 | -5,406 ||-----------------------------------------------+---------+---------|| Other operating expenses | -30 | -25 ||-----------------------------------------------+---------+---------|| Total operating expenses | -24,893 | -22,620 ||-----------------------------------------------+---------+---------|| Operating result | -24,528 | -22,620 ||-----------------------------------------------+---------+---------|| Financial result | 1,155 | -635 ||-----------------------------------------------+---------+---------|| Income taxes | -34 | 0 ||-----------------------------------------------+---------+---------|| Net loss | -23,407 | -23,255 |+-------------------------------------------------------------------++-------------------------------------------------------------------+| Condensed balance sheet | | || (unaudited) | | ||-------------------------------+---------------+-------------------|| (IFRS, consolidated, in CHF | June 30, 2009 | December 31, 2008 || thousands) | | ||-------------------------------+---------------+-------------------|| Cash and cash equivalents | 53,442 | 75,006 ||-------------------------------+---------------+-------------------|| Pro forma cash and cash | | || equivalents* | 69,752 | n/a ||-------------------------------+---------------+-------------------|| Noncurrent assets | 32,006 | 31,641 ||-------------------------------+---------------+-------------------|| Other current assets | 5,785 | 6,300 ||-------------------------------+---------------+-------------------|| Total assets | 91,233 | 112,947 ||-------------------------------+---------------+-------------------|| | | ||-------------------------------+---------------+-------------------|| Equity | 82,550 | 104,474 ||-------------------------------+---------------+-------------------|| Noncurrent liabilities | 342 | 263 ||-------------------------------+---------------+-------------------|| Current liabilities | 8,341 | 8,210 ||-------------------------------+---------------+-------------------|| Total equity and liabilities | 91,233 | 112,947 |+-------------------------------------------------------------------+* Pro forma adjusted by milestone and upfront payments subsequent toJune 30, 2009+-------------------------------------------------------------------+| Condensed cash flow statement (unaudited) | | ||-----------------------------------------------+---------+---------|| (IFRS, consolidated, for half-year ended | | || June 30, in CHF thousands) | 2009 | 2008 ||-----------------------------------------------+---------+---------|| Gross operating/investing cash flow | -22,013 | -25,491 ||-----------------------------------------------+---------+---------|| | | ||-----------------------------------------------+---------+---------|| Net change in cash and cash equivalents | -21,564 | -25,540 ||-----------------------------------------------+---------+---------|| Cash and cash equivalents at January 1 | 75,006 | 106,618 ||-----------------------------------------------+---------+---------|| Cash and cash equivalents at June 30 | 53,442 | 81,078 |+-------------------------------------------------------------------+The 2009 Interim Report of Santhera Pharmaceuticals including theconsolidated financial statements is available on the Company's Website under www.santhera.com/reports. * * *About SantheraSanthera Pharmaceuticals (SIX: SANN) is a Swiss specialtypharmaceutical company focused on the development andcommercialization of small-molecule pharmaceutical products for thetreatment of severe neuromuscular diseases, an area of high unmetmedical need which includes many orphan indications with no currenttherapy. Santhera's first product, Catena® to treat Friedreich'sAtaxia, is marketed in Canada and in a well-advanced Phase IIIdevelopment program. Recently published study results show that theCompany's second compound JP-1730/fipamezole is efficacious in reducing levodopa-induced Dyskinesia inParkinson's Disease. For further information, please visit theCompany's Web site www.santhera.com.Catena® is a trademark of Santhera Pharmaceuticals.Webcast / TeleconferenceAt 15.00 CET / 14.00 UKT / 09.00 EST on September 4, 2009, Santhera'smanagement will discuss the Interim Results. Anyone interested inparticipating may join either the webcast on www.santhera.com/webcastor the teleconference (ID: 28750892) using one of the followingdial-ins Switzerland 0565 800 007(local call) United States 1866 966 9439 Canada 1866 966 0399 Germany 0692 222 3479 United Kingdom 0844 493 3800 International +44 (0) 1452 555566The webcast will be available for playback one hour after thepresentation ends.For further information, contactKlaus Schollmeier, Chief Executive OfficerPhone: +41 (0)61 906 89 52klaus.schollmeier(at)santhera.comBarbara Heller, Chief Financial OfficerPhone: +41 (0)61 906 89 54barbara.heller(at)santhera.comThomas Staffelbach, Head Public & Investor RelationsPhone: +41 (0)61 906 89 47thomas.staffelbach(at)santhera.comDisclaimer/Forward-looking statementsThis communication does not constitute an offer or invitation tosubscribe for or purchase any securities of Santhera PharmaceuticalsHolding AG. This publication may contain certain forward-lookingstatements concerning the Company and its business. Such statementsinvolve certain risks, uncertainties and other factors which couldcause the actual results, financial condition, performance orachievements of the Company to be materially different from thoseexpressed or implied by such statements. Readers should therefore notplace undue reliance on these statements, particularly not inconnection with any contract or investment decision. The Companydisclaims any obligation to update these forward-looking statements.http://hugin.info/137261/R/1339489/319883.pdf --- End of Message ---Santhera Pharmaceuticals Holding AGHammerstrasse 47 Liestal SwitzerlandWKN: A0LCUK; ISIN: CH0027148649; Index: SPI, SPIEX, SSCI;Listed: Main Market in SIX Swiss Exchange;
Datum: 04.09.2009 - 07:00 Uhr
Sprache: Deutsch
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