Horizon Pharma plc Completes Sale of European Marketing Rights for PROCYSBI® (cysteamine bitartrate) delayed-release capsule...
June 23 2017 - 11:00AM
Horizon Pharma plc (NASDAQ:HZNP) (Horizon), a biopharmaceutical
company focused on improving patients’ lives by identifying,
developing, acquiring and commercializing differentiated and
accessible medicines that address unmet medical needs, today
announced that it has completed the sale of a European subsidiary
that owns the marketing rights to PROCYSBI® (cysteamine bitartrate)
delayed-release capsules and QUINSAIR™ (levofloxacin nebuliser
solution) in Europe, the Middle East and Africa (EMEA) regions to
Chiesi Farmaceutici S.p.A. (Chiesi) for an upfront payment of $72.2
million, with additional potential milestone payments based on
sales targets.
Horizon will maintain control of manufacturing supply in the
EMEA regions through its third party supplier. In addition,
Horizon will maintain marketing rights for PROCYSBI and QUINSAIR in
the United States, Canada and Latin America. The divested
subsidiary has facilities in the Netherlands, France and Germany
and has approximately 40 employees.
As previously announced, Horizon anticipates the
divestiture to result in a reduction of full-year 2017 net
sales by approximately $15 million related to PROCYSBI and QUINSAIR
in the EMEA region, with a neutral impact to its full-year 2017
adjusted EBITDA. Accordingly, the company's full-year 2017 net
sales are now expected to be in a range of $985 million
to $1.020 billion. Horizon's full-year 2017 adjusted
EBITDA guidance range of $315 million to $350 million has not
changed.
About Horizon Pharma plcHorizon Pharma plc is a
biopharmaceutical company focused on improving patients' lives by
identifying, developing, acquiring and commercializing
differentiated and accessible medicines that address unmet medical
needs. The Company markets 11 medicines through its orphan,
rheumatology and primary care business units. For more
information, please visit www.horizonpharma.com. Follow
@HZNPplc on Twitter or view careers on our LinkedIn page.
Chiesi Farmaceutici S.p.A. Based in
Parma, Italy, Chiesi Farmaceutici is an international
research-focused Healthcare Group, with over 80 years of experience
in the pharmaceutical industry, present in 26 countries.
Chiesi researches, develops and markets innovative drugs in
the respiratory therapeutics, specialist medicine and rare disease
areas. Its R&D organization is headquartered in Parma
(Italy), and integrated with 6 other key R&D groups in France,
the USA, the UK, Sweden and Denmark to advance Chiesi's
pre-clinical, clinical and registration programmes. Chiesi
employs nearly 5,000 people. For more information, visit
www.chiesi.com.
Note Regarding Use of Non-GAAP Financial
Measures EBITDA, or earnings before interest, taxes,
depreciation and amortization, and adjusted EBITDA are used and
provided by Horizon Pharma as non-GAAP financial measures and
include adjustments to GAAP figures. These non-GAAP measures are
intended to provide additional information on Horizon Pharma’s
performance, operations, expenses, profitability and cash flows.
Adjustments to EBITDA exclude acquisition- and disposition-related
expenses, charges related to the discontinuation of ACTIMMUNE
development for Friedreich’s ataxia, an upfront fee for a license
of a patent, a litigation settlement, loss on debt extinguishment
and loss on sale of long-term investments, costs of debt
refinancing, drug manufacturing harmonization costs, as well as
non-cash items such as share-based compensation, depreciation and
amortization, royalty accretion, non-cash interest expense,
intangible and other non-current asset impairment charges, and
other non-cash adjustments. Certain other special items or
substantive events may also be included in the non-GAAP adjustments
periodically when their magnitude is significant within the periods
incurred. Horizon Pharma maintains an established non-GAAP cost
policy that guides the determination of what costs will be excluded
in non-GAAP measures. Horizon Pharma believes that these non-GAAP
financial measures, when considered together with the GAAP figures,
can enhance an overall understanding of Horizon Pharma’s financial
and operating performance. The non-GAAP financial measures are
included with the intent of providing investors with a more
complete understanding of the Company’s expected 2017 financial
results and trends and to facilitate comparisons between periods
and with respect to projected information. In addition, these
non-GAAP financial measures are among the indicators Horizon
Pharma’s management uses for planning and forecasting purposes and
measuring the Company’s performance. For example, adjusted EBITDA
is used by Horizon Pharma as one measure of management performance
under certain incentive compensation arrangements. These non-GAAP
financial measures should be considered in addition to, and not as
a substitute for, or superior to, financial measures calculated in
accordance with GAAP. The non-GAAP financial measures used by the
Company may be calculated differently from, and therefore may not
be comparable to, non-GAAP financial measures used by other
companies. Horizon Pharma has not provided a reconciliation of its
full-year 2017 adjusted EBITDA outlook to an expected net income
(loss) outlook because certain items such as acquisition- and
disposition-related expenses and share-based compensation that are
a component of net income (loss) cannot be reasonably projected due
to the significant impact of changes in Horizon Pharma’s stock
price, the variability associated with the size or timing of
acquisitions or dispositions and other factors. These components of
net income (loss) could significantly impact Horizon Pharma’s
actual net income (loss).
Forward-Looking Statements This press release
contains forward-looking statements, including, but not limited to,
statements related to the sale of Horizon Pharma’s European
subsidiary (including the marketing rights to PROCYSBI and QUINSAIR
in the EMEA region) to Chiesi, including the expected impact of the
transaction to Horizon Pharma’s 2017 financial results. These
forward-looking statements are based on Horizon Pharma's current
expectations and inherently involve significant risks and
uncertainties. Actual results and the timing of events could
differ materially from those anticipated in such forward looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks related to Horizon Pharma’s
ability to realize expected cost savings following the closing of
the proposed sale transaction; risks related to future
opportunities and Horizon Pharma’s ability to capitalize on such
opportunities, Horizon Pharma’s ability to maintain commercial
partnerships for RAVICTI and BUPHENYL in Europe, as well as other
risks related to Horizon's business detailed from time-to-time
under the caption "Risk Factors" and elsewhere in Horizon Pharma's
SEC filings and reports, including in its Annual Report on Form
10-K for the year ended December 31, 2016 and subsequent quarterly
reports on Form 10-Q. Horizon Pharma undertakes no duty or
obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or
changes in its expectations.
Contacts:
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizonpharma.com
Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizonpharma.com
U.S. Media Contact:
Geoffrey Curtis
Senior Vice President, Corporate Affairs & Chief Communications Officer
media@horizonpharma.com
Ireland Media Contact:
Ray Gordon
Gordon MRM
ray@gordonmrm.ie
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