Santhera will hold a conference call today at
- Net revenues of CHF 7.8 million, operating expenses reduced by 16%, net result of CHF -31.9 million
- Closing of financing arrangements in April and July to provide in total up to CHF 32 million with the option to increase to up to CHF 44 million
- Puldysa® (idebenone) expecting CHMP opinion in Q4-2020 following inclusion of data from SIDEROS trial interim analysis
- Vamorolone VISION-DMD study nearing full enrollment and 6-month topline results expected in Q2-2021
- Worldwide rights to vamorolone in Duchenne muscular dystrophy and all other indications obtained in
September 2020
Pratteln,
“Our primary focus continues to be on advancing our business towards several significant inflection points with our DMD drug candidates, Puldysa and vamorolone, and securing sufficient funds to enable the ongoing implementation of our growth plans,” said
He added: “Our sincere thanks go to all clinical trial participants, their families and carers, for their commitment to advancing our drug candidates in minimizing the delays under the severe constraints imposed by the Covid-19 pandemic. Likewise, we are also appreciative of the investor support which allowed us to obtain additional financing under challenging market conditions. I am confident that the upcoming value-enhancing inflection points will trigger further interest in Santhera and facilitate the raising of additional finance to support ongoing development and commercialization activities.”
KEY FINANCIALS
- Net revenues from product sales of CHF 7.8 million
- Operating expenses of CHF -31.9 million, reduced by 16%
- Net result of CHF -31.8 million (1H-2019: CHF -26.9 million)
- Cash and cash equivalents of CHF 19.4 million (
June 30, 2020 ) - Operating cash flow CHF -19.8 million
Sales of Raxone phasing out after transfer of business to
In the first six months 2020, Santhera reported revenue from contracts with customers of CHF 7.8 million (1H-2019: CHF 18.3 million). The majority of this revenue reflects sales of Raxone for the treatment of Leber’s hereditary optic neuropathy (LHON) in
Operating cost reductions of 16%
As a result of rigorous cost saving measures, total operating expenses for the first half 2020 decreased by 16% year-on-year to CHF 31.9 million (1H-2019: CHF 38.2 million). Development expenses were down 8% to CHF 17.7 million (1H-2019: CHF 19.3 million) and reflect primarily costs for ongoing late stage clinical studies, including the Phase 3 SIDEROS trial in DMD, and efforts associated with the pending marketing authorization application for Puldysa for DMD in
Recent financings provide additional liquidity
As of
In April, Santhera entered into a financing arrangement with IRIS (
In parallel, the Company is evaluating a restructuring of the CHF 60 million Senior Unsecured Convertible Bonds with a
For ongoing development activities, the preparation for commercial launch of Puldysa and the payments due following the exercise of the sub-license option for vamorolone, Santhera will require further additional funding.
From
PIPELINE MILESTONES AND PROGRESS
With Puldysa and vamorolone, Santhera is building a complementary DMD product portfolio. The Company expects the availability of both vamorolone and Puldysa to address the medical needs of DMD patients, from early to late disease stages, irrespective of age, underlying dystrophin mutation or ambulatory status. Santhera’s pipeline priorities for the remainder of 2020 continue to focus on advancing its neuromuscular franchise in DMD, with Puldysa and vamorolone, towards value-enhancing inflection points:
September 2, 2020 : Santhera obtains worldwide rights to vamorolone in all indications- Q4-2020: Interim analysis of SIDEROS study and inclusion of data into regulatory dossier
- Q4-2020: CHMP opinion on marketing authorization application for Puldysa in DMD in
Europe - Q1-2021: Launch of Puldysa in first European markets
- Q2-2021: Read-out of topline data of pivotal Phase 2b trial for vamorolone in DMD
- Q4-2021: NDA (new drug application) filing in the US for vamorolone in DMD
Puldysa—ahead of DMD SIDEROS interim analysis and CHMP opinion
Puldysa highlights in the first half-year were the renewal of the Early Access to Medicines Scheme (EAMS) scientific opinion in the
Vamorolone—encouraging new long-term clinical data and VISION-DMD nearly fully enrolled
In June, Santhera’s partner ReveraGen completed a long-term, open-label 24-month extension study (VBP15-LTE) in patients with DMD. Enrolled in this study were patients who had previously completed a 6-month dose escalation study (VBP15-003) which demonstrated dose-dependent improvement in timed function tests and good tolerability. Taken together, ReveraGen has now obtained safety and efficacy data with vamorolone over a period of 2.5 years in 41 boys with DMD. Currently ongoing is the pivotal VISION-DMD study which compares the efficacy and tolerability profile of vamorolone versus placebo and prednisolone to determine whether vamorolone improves muscle strength and function compared to placebo and whether it has less side effects compared to prednisolone, thereby potentially making it a valuable alternative to standard corticoid treatments. The next study milestone will be the soon expected full enrollment into the study followed by topline 6-month data readout anticipated in the second quarter of 2021 which, if positive, could allow for an NDA filing in the fourth quarter of 2021.
Vamorolone—worldwide rights for all indication obtained
On
Progress made with earlier pipeline projects
Santhera is advancing its Phase 1b study with clinical stage candidate lonodelestat for cystic fibrosis. The compound’s potential as a therapeutic intervention for COVID-19-related acute respiratory distress syndrome (ARDS) is investigated in preclinical research by
Outlook
The operational priorities for Santhera in the second half of 2020 are the preparation for European market entry of Puldysa in DMD in early 2021, advancing vamorolone towards the VISION-DMD top-line data readout and securing additional funding to allow the Company to pursue its operations as planned.
Reference:
[1] Press release “Santhera Exercises Option to Obtain Worldwide Rights to Vamorolone in Duchenne Muscular Dystrophy and All Other Indications”,
2020 Half-year Financial Information
Santhera’s 2020 Half-year Report see www.santhera.com/investors-and-media/investor-toolbox/financial-reports.
Condensed consolidated income statement (reviewed, IFRS, for half-year ended | 1H-2020 | 1H-2019 |
Net sales | 6,133 | 18,315 |
Net sales to licensing partner | 1,642 | 0 |
Revenue from contracts with customers | 7,775 | 18,315 |
Cost of goods sold (of which amortization intangible assets: 1H-2020 -1,519 / 1H-2019 -1,519) | -2,114 | -2,557 |
Development | -17,688 | -19,325 |
Marketing and sales | -6,766 | -11,611 |
General and administrative | -7,209 | -7,206 |
Operating expenses | -31,911 | -38,208 |
Operating result | -25,893 | -22,434 |
Financial result | -5,573 | -4,065 |
Income taxes | -361 | -401 |
Net result | -31,827 | -26,900 |
Basic and diluted loss per share (in CHF) | -2.78 | -2.47 |
Condensed consolidated balance sheet (IFRS, in CHF thousands) | (reviewed) | (audited) |
Cash and cash equivalents | 19,353 | 31,358 |
Other current assets | 17,201 | 17,897 |
Noncurrent assets | 63,520 | 65,796 |
Total assets | 100,074 | 115,051 |
Equity | 210 | 21,247 |
Noncurrent liabilities | 69,894 | 69,840 |
Current liabilities | 29,970 | 23,964 |
Total equity and liabilities | 100,074 | 115,051 |
Condensed consolidated cash flow statement (reviewed, IFRS, in CHF thousands) | 2020 | 2019 |
Operating cash flow for the half-year ended | -19,795 | -20,219 |
Investing cash flow for the half-year ended | 1,506 | 1,448 |
Financing cash flow for the half-year ended | 6,405 | 9,465 |
Cash and cash equivalents at | 31,358 | 21,971 |
Cash and cash equivalents at | 19,353 | 12,698 |
Net change in cash and cash equivalents | -12,005 | -9,273 |
Share capital (number of shares with par value of CHF 1) | (reviewed) | (audited) |
Shares issued | 13,185,063 | 11,165,063 |
Conditional capital for equity rights | 687,052 | 687,052 |
Conditional capital for convertible rights | 4,800,000 | 2,500,000 |
Authorized capital | 4,630,000 | 3,000,000 |
Half-year Report
The Santhera Half-year Report 2020 is available for download on the Company’s website at www.santhera.com/investors-and-media/investor-toolbox/financial-reports.
Conference Call
Santhera will host a conference call on
Europe: +41 58 310 50 00
UK: +44 207 107 06 13
USA: +1 631 570 56 13
About Santhera
Puldysa® and Raxone® are trademarks of
For further information please contact:
public-relations@santhera.com or
Phone: +41 79 875 27 80
eva.kalias@santhera.com
Disclaimer / Forward-looking statements
This communication does not constitute an offer or invitation to subscribe for or purchase any securities of
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Attachment
- 2020 09 08_HY2020_e_final
Source:
2020 GlobeNewswire, Inc., source