Hold the Presses is your online newsportal en brings press releases from around the world. Journalists can use it for free, although it is their responsibilty to check the news. Hold the Presses is in no way responsible for the content of the press releases, the Sender is. We hope you enjoy reading the news we bring you on this website. If a message is published that is not acceptable, we apologize. Please contact us and we will remove the message as soon as possible.

Tuesday, 5 September 2017

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

Santhera Pharmaceuticals Holding AG    

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

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.

 

 

 

2017 Half-Year Financial Information

 

Please see www.santhera.com/investors-and-media/investor-toolbox/financial-reports for Santhera's 2017 interim condensed report and all reviewed consolidated financial statements.

 

Condensed interim consolidated income statement
(reviewed, IFRS, for half-year ended June 30, in CHF thousands)

1H 2017

1H 2016

Net sales

10,859

7,210

Cost of goods sold
(of which amortization of intangible assets: 2017 -1,519 / 2016 -1,519)

-1,954

-1,911

Development

-11,703

-8,101

Marketing and sales

-12,622

-8,949

General and administrative

-6,113

-5,479

Operating expenses

-30,513

-22,567

Operating result

-21,366

-17,207

Financial result

-1,289

85

Income taxes

-57

-849

Net result

-22,712

-17,971

Basic and diluted loss per share (in CHF)

-3.62

-2.87

 

Condensed interim consolidated balance sheet
(IFRS, in CHF thousands)

June 30, 2017
(reviewed)

Dec. 31, 2016
(audited)

Cash and cash equivalents

71,986

49,815

Financial assets short-term

5,984

0

Noncurrent assets

33,239

28,442

Other current assets

18,945

12,535

Total assets

130,154

90,792

Equity

55,199

74,351

Noncurrent liabilities

63,647

6,183

Current liabilities

11,308

10,258

Total equity and liabilities

130,154

90,792

 

Condensed interim consolidated cash flow statement
(reviewed, IFRS, in CHF thousands)

2017

2016

Operating cash flow for half-year ended June 30

-19,431

-13,338

Investing cash flow for half-year ended June 30

-15,352

-259

Financing cash flow for half-year ended June 30

57,001

336

Cash and cash equivalents at January 1

49,815

76,859

Cash and cash equivalents at June 30

71,986

63,564

Net change in cash and cash equivalents

22,171

-13,295

 

Share capital
(number of shares with par value of CHF 1)

June 30, 2017
(reviewed)

Dec. 31, 2016
(audited)

Shares issued

6,279,857

6,279,857

Conditional capital for stock options

700,000

532,941

Conditional capital for convertible rights

930,000

650,000

Authorized capital

1,500,000

1,500,000

 

 

 

Call for Investors and Analysts

Santhera will host an investor call September 5, 2017 at 13:00 CET. Thomas Meier, PhD, CEO of Santhera, will discuss the half-year 2017 financial results and will provide an update on corporate developments.

Participants are invited to call the following numbers 10-15 minutes before scheduled call (no dial-in code required):

Europe: +41 (0)58 310 50 00

UK: +44 (0)203 059 58 62

US: +1 631 570 5613

 

About Santhera

Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan mitochondrial and neuromuscular diseases. Santhera's lead product Raxone® (idebenone) is authorized in the European Union, Norway, Iceland, Liechtenstein and Israel for the treatment of Leber's hereditary optic neuropathy (LHON). For Duchenne muscular dystrophy (DMD), Santhera has filed a Marketing Authorization Application in the European Union and Switzerland for DMD patients with respiratory function decline who are not taking glucocorticoids. In collaboration with the U.S. National Institute of Neurological Disorders and Stroke (NINDS) Santhera is developing Raxone® in a third indication, primary progressive multiple sclerosis (PPMS), and omigapil for congenital muscular dystrophy (CMD), all areas of high unmet medical need. For further information, please visit the Company's website www.santhera.com.

Raxone® is a trademark of Santhera Pharmaceuticals.

 

For further information:

Sue Schneidhorst, Head Group Communications

Europe: +41 61 906 89 26

US: +1 646 586 2113

sue.schneidhorst@santhera.com

 

Investors:

Christoph Rentsch, Chief Financial Officer                      Hans Vitzthum, LifeSci Advisors

Europe: +41 61 906 89 65                                              US: +1 212 915 2568

christoph.rentsch@santhera.com                                   hans@lifesciadvisors.com

 

Disclaimer / Forward-looking statements

This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Santhera Pharmaceuticals Holding AG. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.


# # #



News Release HY2017



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of NASDAQ OMX Corporate Solutions clients. Source: Santhera Pharmaceuticals Holding AG, Hammerstrasse 49, Liestal CH-4410, Schweiz
If you would like to unsubscribe and stop receiving these e-mails click here.