Horizon Pharma plc (NASDAQ:HZNP), 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 reached an agreement to sell a European subsidiary that owns
the marketing rights to PROCYSBI® (cysteamine bitartrate)
delayed-release capsules and QUINSAIR™ (levofloxacin inhalation
solution) in Europe, the Middle East and Africa (EMEA) regions to
Chiesi Farmaceutici S.p.A. (Chiesi) for an upfront payment of $70
million, with additional potential milestone payments based on
sales targets. The transaction is subject to receipt of
antitrust approvals and other customary closing conditions and is
expected to close by the end of the second quarter.
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.
“Following the Raptor acquisition at the end of last year, we
completed an evaluation of the commercial infrastructure required
to provide PROCYSBI and QUINSAIR in Europe, the Middle East and
Africa, and determined that these medicines would be best supported
by a company with a larger geographic footprint,” said Timothy P.
Walbert, chairman, president and chief executive officer, Horizon
Pharma plc. “We will continue to provide RAVICTI and BUPHENYL
in Europe and other non-U.S. markets through our commercial
partnership strategy.”
“The acquisition of the marketing rights for PROCYSBI and
QUINSAIR will further strengthen our rare disease offering in the
EMEA regions,” said Ugo Di Francesco, CEO of Chiesi Farmaceutici
S.p.A. “We have a strong commitment to the rare disease area
and this is an important opportunity to enhance our portfolio and
contribute to improve the quality of life of nephropathic
cystinosis and cystic fibrosis patients.”
Assuming a second-quarter 2017 transaction close, Horizon
anticipates a reduction of approximately $15 million in full-year
2017 net sales related to PROCYSBI and QUINSAIR in the EMEA regions
and a neutral impact on its full-year 2017 adjusted EBITDA. This
would result in a full-year 2017 net sales guidance range of $985
million to $1.020 billion and no change to Horizon’s full-year 2017
adjusted EBITDA guidance range of $315 million to $350 million.
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 anticipated sale of Horizon Pharma’s
European subsidiary (including the marketing rights to PROCYSBI and
QUINSAIR in the EMEA region) to Chiesi, including the expected
timing thereof, the expected impact of the transaction to Horizon
Pharma’s 2017 financial results, Horizon Pharma's strategy, plans,
objectives, expectations (financial or otherwise) and intentions,
including with respect to Horizon Pharma’s plans to continue
providing RAVICTI and BUPHENYL in Europe and other non-U.S. markets
through its commercial partnership strategy, and other statements
that are not historical facts. 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 whether and when the
parties are able to satisfy the closing conditions with respect to
the proposed sale transaction; 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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