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Press Release

Santhera Announces Financial Results for the First Half-Year 2017 and Reports Commercial and Development Progress

Santhera
Posted on: 06 Sep 17

Liestal, Switzerland, September 5, 2017 - Santhera Pharmaceuticals (SIX: SANN) reports first half-year results as of June 30, 2017:

  • 1H 2017 sales of CHF 10.9 million, increase of 51% compared to 1H 2016
  • Successful placement of CHF 60 million in convertible bonds
  • Cash and short-term financial assets of CHF 78.0 million
  • Continued roll-out of commercial launch of Raxone® for Leber's hereditary optic neuropathy (LHON)
  • Positive Early Access to Medicines Scheme (EAMS) scientific opinion from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) received for Raxone in Duchenne muscular dystrophy (DMD)
  • European marketing authorization application (MAA) decision for Raxone in DMD from Committee for Medicinal Products for Human Use (CHMP) anticipated shortly

 

Summarizing the half-year performance, Thomas Meier, PhD, Chief Executive Officer of Santhera, said: "We are on track to achieve our goals for 2017. On the commercial side, we have successfully advanced the European roll-out of Raxone for LHON and our commercial operations for our anticipated launch of Raxone in DMD are well underway. Recently, the UK's MHRA has granted Raxone a positive scientific opinion through the EAMS for patients with respiratory function decline not taking glucocorticoids in DMD. Another highlight was the successful placement of convertible bonds, which equipped us with adequate financial resources to implement our strategic and operational plans, and reflects the endorsement of the financial community in Santhera's future."

 

Company Highlights

  • Roll-out of Raxone for LHON well underway
    Santhera's intention to make Raxone available for LHON patients across Europe are progressing well with new launches in several countries either through own subsidiaries or partnerships. Reimbursement was achieved under different models in several European markets. In May, the Scottish Medicines Consortium approved Raxone for restricted use in patients with LHON. By the end of the first half-year, Santhera sold Raxone in 17 European countries.
  • First positive EAMS Scientific Opinion from UK's MHRA in DMD
    In June, the UK's MHRA granted Raxone a positive scientific opinion through the EAMS for patients with respiratory function decline not taking glucocorticoids in DMD. The MHRA decision allows patients with DMD, who meet criteria defined under this scheme, and who otherwise would not have access to such treatment options, to gain access to Raxone.
  • Review of marketing authorization application for DMD in Europe
    The CHMP is currently assessing Santhera's extension application for Raxone in patients with DMD. An opinion from the CHMP is expected shortly.
  • Commercial operations strengthened to support LHON and prepare for launch in DMD
    Commercial operations in the regional country clusters in Europe were increased to support marketing of Raxone for LHON and to prepare for a timely market entry of Raxone for DMD. In February, US operations were established in the Boston metropolitan area. The US team is currently focused on expanding relationships with patient advocacy groups, market preparation activities, and providing regulatory and medical affairs expertise. This expansion of geographic reach underscores Santhera's commitment to make Raxone available to patients worldwide.
  • SIDEROS trial with Raxone in DMD patients using glucocorticoids on track
    Santhera's randomized, double-blind, placebo-controlled phase III SIDEROS study investigates the efficacy and safety of Raxone in DMD patients with declining respiratory function on any stable glucocorticoid treatment scheme. Currently, the last remaining of the targeted 62 study centers are being initiated. The study is expected to run until 2019 to support the use of Raxone in all patients with DMD experiencing respiratory decline irrespective of their glucocorticoid use status.
  • Israel approves Raxone for LHON
    Post the period end, the Ministry of Health Israel approved Raxone for the treatment of visual impairment in adolescents and adult patients with LHON. This is the first approval for Raxone in LHON outside Europe.

 

Key Financials in the First Half-Year 2017

  • Strong uptake of Raxone sales
    Net sales of Raxone amounted to CHF 10.9 million (1H 2016: CHF 7.2 million) which corresponds to a 51% increase compared to the same period of the year prior. Turnover was mainly driven by sales to LHON patients in Germany and France with additional markets contributing increasingly to growth. To date, Raxone is sold in 17 European countries.
  • Commercial and development activities reflected in increased expenses
    Operating expenses in the first half-year were CHF 30.5 million (1H 2016: CHF 22.6 million). Advancing late stage clinical trials, as well as the follow-up and preparation of regulatory filings for DMD, led to higher development expenses of CHF 11.7 million (1H 2016: CHF 8.1 million). Marketing and sales expenses reached CHF 12.6 million (1H 2016: CHF 8.9 million) and general and administrative expenses (G&A) were CHF 6.1 million (1H 2016: CHF 5.5 million). This investment increase reflects the expansion of Santhera's operations, including set-up of the US subsidiary, the ongoing roll-out of Raxone for LHON across Europe and market entry preparations for Raxone in DMD. In summary, the operating loss in the first half of this year amounted to CHF 21.4 million (1H 2016: CHF -17.2 million) leading to a net result of CHF -22.7 million (1H 2016: CHF -18.0 million).
  • Successful placement of CHF 60 million convertible bonds
    In February, Santhera successfully placed CHF 60 million senior unsecured convertible bonds with a 5-year maturity and a coupon of 5.00% per annum. Net proceeds from this placement will primarily be used to fund the commercialization of Raxone in the currently approved indication LHON, to prepare the market entry and commercial launch in the subsequent indications, and to further advance clinical development programs and for other corporate purposes. The additional funds significantly enhanced the Company's financial flexibility in executing its intended development and commercial plans.
  • Solid liquidity base allows for strategy implementation as planned
    As of June 30, 2017, freely available liquid funds (cash and cash equivalents including short-term financial assets) amounted to CHF 78.0 million (December 31, 2016: CHF 49.8 million).

 

Revenue Guidance

Santhera reiterates its revenue outlook and currently expects net sales of Raxone for full year 2017 to reach CHF 21 to 23 million.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 06/09/2017

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