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
(Thomson Reuters ONE) -
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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The issuer is 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(®) 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
In June, additional data from the pivotal phase III trial (DELOS) were published
in Neuromuscular Disorders, the official journal of the World Muscle Society
(McDonald et al., Neuromuscular Disorders 2016, 26: 473-480). These data show
that DMD patients treated with Raxone have a reduced risk of bronchopulmonary
complications including fewer hospitalizations caused by such complications and
a reduced need for systemic antibiotic treatment compared to patients receiving
placebo.
* Received US fast-track designation for omigapil - CALLISTO study on track
In May, Santhera received Fast Track Designation from the FDA for omigapil for
the treatment of congenital muscular dystrophy (CMD). Previously, omigapil was
granted Orphan Drug Designation for CMD in both the EU and the US. Santhera, in
collaboration with the US National Institutes of Health (NIH), is currently
conducting a clinical phase I study (CALLISTO) with omigapil in CMD patients.
CALLISTO assesses the pharmacokinetics, safety, and tolerability of omigapil in
ambulatory and non-ambulatory children affected by CMD. On August 30, Santhera
announced that the Office of Orphan Products Development (OOPD) at the FDA has
granted Santhera an award of USD 246'000 in support of its ongoing CALLISTO
trial.
* SIDEROS trial with Raxone in DMD-patients using glucocorticoids to start
imminently
The first patient is expected to be enrolled shortly in Santhera's randomized,
double-blind, placebo-controlled phase III SIDEROS study. The trial is designed
to confirm the efficacy of Raxone in patients currently taking glucocorticoids
who are experiencing respiratory function decline, a patient population
previously not enrolled in the positive phase III DELOS trial. If successful,
this study will provide data to support the use of Raxone in all DMD patients
experiencing respiratory decline irrespective of their glucocorticoid use
status. Raxone for DMD was granted Orphan Drug Designation in the EU and the US
and Fast Track Designation in the US.
Outlook and Guidance
The Marketing Authorization Application for Raxone in DMD is currently under
review by the CHMP and Santhera expects a response from the regulatory authority
in the first quarter 2017.
In July 2016, Santhera was advised by the FDA that the successful completion of
the SIDEROS trial together with data from the previously successful phase III
DELOS trial will provide the necessary data to support NDA filing for Raxone in
all DMD patients irrespective of the glucocorticoid use status. In the interest
of patients and due to the fact that the benefit of Raxone has already been
demonstrated in the glucocorticoid non-using patients, Santhera will approach
the FDA with the intent to re-engage in further discussions on an accelerated
pathway to approval specifically for this patient population.
Santhera currently expects net sales of Raxone in 2016 to reach CHF 16 to 18
million.
2016 Half Year Financial Information
See www.santhera.com for Santhera's 2016 Interim Condensed Report and all
reviewed consolidated financial statements.
Condensed interim consolidated income statement 1H 2016 1H 2015 (1)
(reviewed, IFRS, for half year ended June 30, in CHF
thousands)
-------------------------------------------------------------------------------
Net sales 7,210 1,455
Cost of goods sold
(of which amortization of intangible assets: 2016 -1,519 /
2015 0) -1,911 -159
-------------------------------------------------------------------------------
Development -8,101 -2,863
Marketing and sales -8,949 -1,535
General and administrative -5,479 -3,133
Operating expenses -22,567 -7,535
-------------------------------------------------------------------------------
Operating result -17,207 -6,216
-------------------------------------------------------------------------------
Financial result 85 -162
Income taxes -849 -2
Net result -17,971 -6,380
-------------------------------------------------------------------------------
Basic and diluted loss per share (in CHF) -2.87 -1.28
-------------------------------------------------------------------------------
Condensed interim consolidated balance sheet June 30, 2016 Dec. 31, 2015
(IFRS, in CHF thousands) (reviewed) (audited)
-------------------------------------------------------------------------------
Cash and cash equivalents 63,564 76,859
Noncurrent assets 31,015 33,208
Other current assets 10,301 7,085
Total assets 104,880 117,152
-------------------------------------------------------------------------------
Equity 89,190 106,247
Noncurrent liabilities 5,601 3,957
Current liabilities 10,089 6,948
Total equity and liabilities 104,880 117,152
-------------------------------------------------------------------------------
Condensed interim consolidated cash flow statement 2016 2015
(reviewed, IFRS, in CHF thousands)
------------------------------------------------------------------------
Operating cash flow for half year ended June 30 -13,338 -7,167
Cash and cash equivalents at January 1 76,859 17,435
Cash and cash equivalents at June 30 63,564 10,476
Net change in cash and cash equivalents -13,295 -6,959
------------------------------------------------------------------------
Share capital June 30, 2016 Dec. 31, 2015
(number of shares with par value of CHF 1) (reviewed) (audited)
-----------------------------------------------------------------------------
Shares issued 6,274,598 6,262,798
Conditional capital for stock options 538,200 401,694
Conditional capital for convertible rights 650,000 650,000
Authorized capital 1,500,000 910,000
-----------------------------------------------------------------------------
(1) Some amounts have been restated in comparison with the Interim Report 2015.
Further details related to the nature of the corrections are outlined in the
Annual Report 2015 (note 2 "Correction of errors").
Call for Investors and Analysts
Santhera will host an Investor Call on September 6, 2016 at 5pm CET. Thomas
Meier, CEO of Santhera, will discuss the Half Year 2016 Financial Results and
will provide an update on corporate developments.
Participants can call the following numbers 10-15 minutes before Conference's
schedule (no dial-in code needed):
+41 (0)58 310 50 00 (Europe)
+44 (0)203 059 58 62 (UK)
+1 (1)631 570 5613 (USA)
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 is authorized in the European Union, Norway,
Iceland and Liechtenstein for the treatment of Leber's hereditary optic
neuropathy (LHON). For Duchenne muscular dystrophy (DMD), the second indication
for Raxone, Santhera has filed a Marketing Authorization Application (MAA) in
the European Union. In collaboration with the US 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, contact:
Thomas Meier, PhD, Chief Executive Officer Christoph Rentsch,
Chief Financial Officer
Phone +41 61 906 89 64 Phone
+41 61 906 89 65
thomas.meier(at)santhera.com
christoph.rentsch(at)santhera.com
Daniel Piller, Head Communications
Phone +41 61 906 89 26
daniel.piller(at)santhera.com
US investor contact: US Public Relations
contact:
Hans Vitzthum, LifeSci Advisors, LLC Deanne Eagle,
Planet Communications
Phone +1 212 915 2568 Phone
+1 917 837 5866
hans(at)lifesciadvisors.com
deanne(at)planetcommunications.nyc
Disclaimer / Forward-looking statements
This press release 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.
# # #
Press release HY-2016:
http://hugin.info/137261/R/2039785/760493.pdf
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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Santhera Pharmaceuticals Holding AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.09.2016 - 07:00 Uhr
Sprache: Deutsch
News-ID 492717
Anzahl Zeichen: 22911
contact information:
Town:
Liestal
Kategorie:
Business News
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