Santhera Pharmaceuticals Holding AG / Santhera Announces Financial
Results for the First Half Year 2016 and Reports Solid Sales Growth -
Company Starts to Build US Operations and Strengthens Board of Directors
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solely responsible for the content of this announcement.
Liestal, Switzerland, September 6, 2016 - Santhera Pharmaceuticals (SIX:
SANN) announces its financial results for the first half year 2016 and
reports solid sales growth. By end of the reporting period sales of
Raxone(R) for Leber's hereditary optic neuropathy (LHON) had reached CHF
7.2 million, recorded primarily in Germany and France with an increasing
sales contribution from additional mid-sized markets. Santhera has filed
a Marketing Authorization Application (MAA) in Europe for Raxone for the
treatment of Duchenne muscular dystrophy (DMD) in patients not taking
glucocorticoids. The MAA was submitted as Type II variation of the
existing marketing authorization for LHON and is currently under review
by the Committee for Medicinal Products for Human Use (CHMP). Santhera
will shortly start a randomized, double-blind, placebo-controlled phase
III (SIDEROS) trial to assess the efficacy of Raxone in DMD patients
receiving concomitant glucocorticoids. If successful, data from this
trial will be used to support a label extension to include all DMD
patients irrespective of their glucocorticoid use status. Santhera will
also approach the US Food and Drug Administration (FDA) with the intent
to re-engage in further discussions on the accelerated approval pathway
for the glucocorticoid non-using patients, in whom clinically relevant
benefit with Raxone has already been demonstrated.
Santhera also reports that it has started to build US operations under
the leadership of Todd Bazemore, who was appointed as Chief Operating
Officer of Santhera Pharmaceuticals (USA) Inc. and member of Santhera's
Executive Management Team. In addition, the Company announces the
nomination of Patrick Vink, MD to Santhera's Board of Directors. Patrick
Vink is a senior life science executive with a track-record in building
global pharmaceutical businesses.
Thomas Meier, PhD, Chief Executive Officer of Santhera, commented on the
first six months of 2016: "The highlights in the first half year were
the solid growth of Raxone sales for LHON in initial markets in Europe
and the submission of our MAA for DMD. The sales uptake has been
somewhat slower than originally expected due to the complex pricing and
reimbursement processes in which we are currently engaged in several EU
markets. As such decisions are expected in the coming months, we
anticipate further growth of Raxone sales in the second half of 2016.
Whilst we await the outcome of the ongoing review of our MAA for DMD, we
are already actively preparing for market entry."
Building US Operations - Appointment of Todd Bazemore as Chief Operating
Officer of Santhera Pharmaceuticals U.S. and Member of Santhera's
Executive Management Team
Santhera is establishing US operations in the Greater Boston Area under
the leadership of Todd Bazemore appointed today as Chief Operating
Officer of Santhera Pharmaceuticals (USA) Inc. He joins Santhera as a
biopharmaceutical executive with 22 years of experience in launching and
building brands and has been instrumental in the success of a number of
drugs across multiple therapeutic areas, spanning from ultra-rare
diseases to large primary care conditions. Prior to joining Santhera
Todd Bazemore served as EVP & Chief Commercial Officer at Dyax Corp.
where he was responsible for global commercial strategy and oversaw all
commercial functions. Dyax was acquired by Shire plc in January of this
year. The US operations will initially be staffed to focus on regulatory
and clinical operations support, medical affairs, patient advocacy
liaison and commercial strategy.
"The US market is a key driver of Santhera's long-term valuation,"
commented Thomas Meier. "I am very pleased that we establish our US
operations now as we plan to engage the FDA in further discussions about
accelerated approval for Raxone in DMD. Todd's strong track record of
strategic leadership, operational execution and launching and building
brands will be highly valuable as we develop our commercial strategy for
the US market. In this important role, Todd will join our Executive
Management Team."
Extending Board of Directors
Santhera plans to extend its Board of Directors with the nomination of
Patrick Vink, MD and senior life science executive with a track-record
of successfully managing global businesses. As a former member of
company executive teams, he adds extensive experience in interacting
with key stakeholders like investors, the financial community and
government officials both from European and US perspectives. In his most
recent operational role he was Executive Vice President and Chief
Operating Officer at Cubist Pharmaceuticals. Patrick Vink acts as
Advisor to the Board of Directors with immediate effect and is
designated for election as a new member of the Board of Directors at the
Company's 2017 Annual Shareholder Meeting.
On the extension of the Board of Directors Martin Gertsch, Chairman of
Santhera's Board of Directors commented: "I am very delighted about the
nomination of Patrick Vink to our Board of Directors. Patrick's strong
track record of growing global life science businesses and his strategic
leadership nicely complements the expertise of the current members of
the Board of Directors."
Key Financials in the First Half Year
-- Increasing sales for Raxone drove topline growth
In the first six months of 2016, Raxone generated net sales of CHF 7.2
million (1H 2015: CHF 1.5 million; 2H 2015: CHF 2.8 million), mainly
driven by increased Raxone sales to LHON patients in Germany and France.
-- Intensified commercial and clinical activities increased operating
expenses
Operating expenses in the first half-year were CHF 22.6 million (1H
2015: CHF 7.5 million). Preparation of regulatory filings for DMD in
Europe and the US and the implementation of late stage clinical trials
led to higher development expenses of CHF 8.1 million (1H 2015: CHF 2.9
million). Marketing and sales expenses rose to CHF 8.9 million (1H 2015:
CHF 1.5 million) and general and administrative expenses (G&A) to CHF
5.5 million (1H 2015: CHF 3.1 million). These increases reflect the
expansion of Santhera's operations, especially the commercial activities,
the ongoing roll-out of Raxone for LHON across Europe and market entry
preparations for Raxone for DMD. In summary, the operating loss amounted
to CHF 17.2 million (1H 2015: CHF -6.2 million) leading to a net result
of CHF -18.0 million (1H 2015: CHF -6.4 million).
-- Sound financial basis to advance commercial and development strategies as
planned
As of June 30, 2016, Santhera had cash and cash equivalents of CHF 63.6
million (December 31, 2015: CHF 76.9 million). Net change in cash and
cash equivalents in the first half year of 2016 was CHF -13.3 million.
Company Highlights
-- Solid uptake of Raxone for LHON in Europe
By end of the reporting period Raxone sales were recorded primarily in
Germany and France with an increasing sales contribution from additional
mid-sized markets. Santhera expects reimbursement decisions by a number
of European Authorities in the second half 2016 and early 2017.
-- Relevance of pulmonary benefits for patients with DMD reconfirmed at
first "Duchenne Pulmonary Outcomes Workshop"
In April 2016, Santhera participated in the "Duchenne Pulmonary Outcomes
Workshop," organized by Parent Project Muscular Dystrophy (PPMD), the
leading U.S. advocacy organization working to end Duchenne. The workshop
convened experts in the research and clinical care of DMD patients who
examined current and future assessments of pulmonary function. Santhera
presented data from its phase III DELOS trial, which demonstrated
clinically relevant efficacy of Raxone (idebenone) in preserving
respiratory function, a key objective for DMD therapy. Previously, a
patient and caregiver survey conducted by PPMD clearly demonstrated that
the DMD community highly values treatment options for pulmonary
complications.
-- Marketing Authorization Application (MAA) filed in Europe for Raxone for
DMD
In May 2016, Santhera submitted a MAA to the European Medicines Agency
(EMA) for Raxone for the treatment of DMD in patients with respiratory
function decline and not taking concomitant glucocorticoids. The new
indication was submitted as Type II variation of the Company's existing
marketing authorization for Raxone which was granted last year. Shortly
thereafter, on June 21, the EMA validated Santhera's application thereby
confirming that the submission is complete and the review process by the
Committee for Medicinal Products for Human Use (CHMP) has begun.
-- Update on US filing strategy for DMD
In July 2016, Santhera reported that the FDA commented on the proposed
subpart H approval pathway and requested that a second phase III trial
be completed providing additional data to support NDA filing for Raxone
in all DMD patients, irrespective of their glucocorticoid use status.
The FDA confirmed that a positive outcome of the planned SIDEROS trial
has the potential to provide the supplementary efficacy data to support
NDA filing in all DMD patients whether they use glucocorticoid or not.
Santhera will work closely with the DMD patient community and clinical
experts with the intent to engage the FDA in further discussions on an
accelerated pathway to approval in the glucocorticoid non-using patients,
in whom clinically relevant benefit has already been demonstrated.
-- Publication on bronchopulmonary benefits of Raxone in DMD in
Neuromuscular Disorders
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September 06, 2016 01:00 ET (05:00 GMT)
