LivaNova Provides Business Update
(Thomson Reuters ONE) -
LONDON, Nov. 12, 2015 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN)
("LivaNova" or the "Company"), a global medical technology company formed by the
merger of Sorin S.p.A ("Sorin"), a leader in the treatment of cardiovascular
diseases, and Cyberonics Inc. ("Cyberonics"), a medical device company with core
expertise in neuromodulation, today provided the sales results for the three and
nine months ended September 30, 2015 for Sorin's Cardiac Surgery and Cardiac
Rhythm Management ("CRM") business units(1), and the thirteen and thirty-nine
weeks ended September 25, 2015 for Cyberonics' Neuromodulation business unit.
These periods will be referred to as the third quarter, or three months ended
September 30, 2015, and the nine months ended September 30, 2015, respectively,
throughout this press release.
Sales Highlights
* Worldwide sales on a combined basis for the three months ended September
30, 2015 were $284.5 million, a decrease of 1.3% on a constant currency
basis as compared to the previous year.
* For the most recent quarter, combined U.S. sales of $120.7 million
represented 42% of total sales, while European sales of $95.6 million
represented 34%, and sales in other markets, including Japan, accounted for
$68.2 million, or 24%, of the Company's total sales.
* For the nine months ended September 30, 2015, worldwide sales on a combined
basis were $884.3 million, an increase of 2.2% on a constant currency basis
over the comparable periods in 2014.
"Overall, our third quarter results, reflecting the pre-merger sales of Sorin
and Cyberonics, represent a diversified revenue base and a solid foundation from
which to grow LivaNova. We are particularly pleased with the Neuromodulation
business unit, where the AspireSR(®) launch is contributing substantially to
results with strong growth from new patients in the U.S. Cardiac Surgery is
expected to return to more normalized growth levels in the fourth quarter, and
the anticipated regulatory approval of the Perceval sutureless valve in the
United States and Japan, should drive further growth in that business unit in
2016. Softness in CRM in the second half of 2015 was expected and previously
communicated. We believe that new product introductions will improve performance
in CRM in 2016," said Andre-Michel Ballester, Chief Executive Officer of
LivaNova.
"Our expectations are that sales for the 2015 calendar year will grow by
approximately 2% on a constant currency basis. Going forward, we are focused on
enhancing shareholder value by growing the top-line, realizing potential
synergies and completing a successful integration. We are firmly on track to
achieve each of these objectives," continued Mr. Ballester.
(1 )Sorin has previously reported sales in euros.
Three months ended September 30, 2015
For the three Business Units, sales were as follows:
Cardiac Surgery (as a business unit of Sorin during the reported period)
Cardiac surgery sales were $145.7 million, representing a 0.4% increase on a
constant currency basis. Sales in the comparable period of 2014 were $161.8
million, with currency changes adversely impacting reported sales by $16.6
million in 2015.
Sales in cardiopulmonary products, including heart-lung machines, oxygenators,
and auto-transfusion machines, were $113.1 million, an increase of 1.3% on a
constant currency basis as compared to the previous year period. Sales in
emerging markets were particularly strong, growing by 8.1% over the comparable
period in 2014.
Heart valve sales, including tissue and mechanical heart valves, were $32.6
million, a decrease of 2.7% on a constant currency basis as compared to the same
period the previous year. Sales in Japan were strong, although sales in the U.S.
and emerging markets slowed from the prior year. Sales of Perceval(®) in Europe
have resumed at an accelerated rate following the resolution of certain
manufacturing issues.
Neuromodulation (as a business unit of Cyberonics during the reported period)
Neuromodulation sales were $84.4 million for third quarter, an increase of
17.4% on a constant currency basis. Sales in the comparable period of 2014 were
$73.2 million, with currency changes adversely impacting sales by $1.5 million
in 2015.
Growth was primarily driven by strong new patient adoption in the U.S. largely
as a result of sales of AspireSR(®) following launch in June 2015, and continued
growth in international markets. Unit growth globally was approximately 10%, and
the 58% adoption rate of AspireSR(® )in the U.S. market drove a favorable
product mix and higher revenue.
CRM (as a business unit of Sorin during the reported period)
CRM sales for the period totaled $53.7 million, a decrease of 21.8% on a
constant currency basis. Sales in the comparable period of 2014 were $80.4
million, with currency changes adversely impacting reported sales by $9.2
million in 2015.
Planned shipments to Japan in the third quarter were significantly lower than in
the prior year ahead of the launch of KORA 250(®), which is anticipated in early
2016, and should support further regaining of market share. Lower shipments are,
however, also expected in the fourth quarter in 2015. Weakness in certain
European markets also contributed to lower sales, although the Platinium(®)
launch in the fourth quarter is expected to contribute meaningfully to sales.
Nine months ended September 30, 2015
For the three Business Units, sales were as follows:
Cardiac Surgery (as a business unit of Sorin during the reported period)
Cardiac surgery sales grew to $450.0 million, an increase of 2.5% on a constant
currency basis. Sales in the comparable period of 2014 were $493.5 million, with
currency changes adversely impacting reported sales by $55.9 million in 2015.
Net sales in cardiopulmonary products grew to $346.4 million, an increase of
4.4% on a constant currency basis as compared to the prior year period. Sales in
emerging markets were particularly strong during this period, growing by 17.6%
over the comparable period.
Heart valve sales, were $103.6 million, a decrease of 3.2% on a constant
currency basis as compared to the same period last year.
Neuromodulation (as a business unit of Cyberonics during the reported period)
Neuromodulation net sales grew to $233.2 million, an increase of 10.1% on a
constant currency basis. Sales in the comparable period of 2014 were $216.6
million, with currency changes adversely impacting sales by $5.3 million in
2015.
Sales growth accelerated following the launch of AspireSR(®) in the U.S. market
in June, 2015.
CRM (as a business unit of Sorin during the reported period)
CRM net sales for the period totaled $199.0 million, a decrease of 5.2% on a
constant currency basis. Sales in the comparable period of 2014 were $249.5
million, with currency changes adversely impacting sales by $37.5 million in
2015.
Lower sales in the U.S. contributed to more than half of this decrease,
following the Company's change in strategy announced in early 2015.Sales during
this period were also impacted by a slowdown in European sales in the third
quarter, as previously noted.
Webcast and Conference Call Instructions
The conference call will be available to interested parties through a live audio
webcast in the Investor Relations section of the LivaNova corporate website at
www.livanova.com. To listen to the conference call live by telephone, dial
877-809-8594 (if dialing from within the U.S.) or 440-996-5677 (if dialing from
outside the U.S.). The conference ID is 66815767.
Within 24 hours of the webcast, a replay will be available under the "Events &
Presentations" section of the Investor Relations portion of the LivaNova
website, where it will be archived and accessible for approximately 12 months.
About LivaNova
LivaNova PLC is a global medical technology company formed by the merger of
Sorin S.p.A, a leader in the treatment of cardiovascular diseases, and
Cyberonics Inc., a medical device company with core expertise in
neuromodulation. LivaNova transforms medical innovation into meaningful
solutions for the benefit of patients, healthcare professionals, and healthcare
systems. The Company employs approximately 4,500 employees worldwide and is
headquartered in London, U.K. With a presence in more than 100 countries,
LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac
Surgery, and Neuromodulation, with operating headquarters in Clamart (France),
Mirandola (Italy) and Houston (U.S.), respectively.
LivaNova is listed on NASDAQ and has been admitted to the standard listing
segment of the Official List of the UK's Financial Conduct Authority and to
trading on the London Stock Exchange (LSE) under the ticker symbol "LIVN".
Financial Alignment, Combined Sales Results, Business Unit Structure and
Constant Currency
Cyberonics, the predecessor company to LivaNova, previously reported on a 52/53
week fiscal year calendar ending in April. With the formal change in the fiscal
calendar of Cyberonics to a fiscal year ended December 31, the historical
Neuromodulation business unit sales have been aligned to correspond as closely
as possible to a third quarter ended September 30, 2015.
Although LivaNova was a shell company with no business operations until the
closing date of the merger on October 19, 2015, the sales results disclosed are
being provided on a combined basis, a non-GAAP formulation that combines the
results of Sorin and Cyberonics for the fiscal periods completed prior to the
merger. The Company believes that presenting the results of Sorin and Cyberonics
in such a manner offers a meaningful representation to investors of the combined
company's sales for these periods. A reconciliation of this information is
attached to this business update.
LivaNova (succeeding to Sorin's and Cyberonics' combined businesses) operates
under a Business Unit structure with Cardiac Surgery, Neuromodulation and CRM
accounting for materially all of the sales during the periods referred to
herein. The combined company also operates a New Ventures group, dedicated to
promising new technologies, particularly in the areas of heart failure, sleep
apnea and percutaneous mitral valve.
Unless otherwise noted, all sales growth rates in this release reflect
comparable, constant currency growth. Constant currency growth measures the
change in sales between current and prior year periods using average exchange
rates in effect during the applicable prior year period.Management believes that
referring to comparable, constant currency growth is a more useful way to
evaluate the sales performance of the newly formed LivaNova and its business
units, and to compare the sales performance of current periods to prior periods
on a consistent basis. A reconciliation of this information is attached to this
business update.
Use of Non-GAAP Financial Measures
In this press release, management has disclosed financial measurements that
present financial information not necessarily in accordance with Generally
Accepted Accounting Principles (GAAP). Company management uses these
measurements as aids in monitoring the Company's ongoing financial performance
from quarter to quarter and year to year on a regular basis and for benchmarking
against other medical technology companies. Non-GAAP financial measures used by
the Company may be calculated differently from, and therefore may not be
comparable to, similarly-titled measures used by other companies. These non-GAAP
financial measures should be considered along with, but not as alternatives to,
the operating performance measure as prescribed per GAAP.
Unless otherwise noted, all sales growth rates in this release reflect
comparable, constant currency growth. Management believes that referring to
comparable, constant currency growth is the most useful way to evaluate the
sales performance of LivaNova and to compare the sales performance of current
periods to prior periods on a consistent basis. Constant currency growth, a non-
GAAP financial measure, measures the change in sales between current and prior
year periods using average exchange rates in effect during the applicable prior
year period.
For further reference, please refer to the attached reconciliations.
Safe harbor statement
This press release contains forward-looking statements within the meaning of
Section 27A of the United States Securities Act of 1933, as amended, and Section
21E of the United States Securities Exchange Act of 1934, as amended. Forward-
looking statements are not historical facts but are based on certain assumptions
of management and describe the Company's future plans, strategies and
expectations, including in reference to the reported financial information for
the Company's legacy Sorin and Cyberonics businesses. Forward-looking statements
can generally be identified by the use of forward-looking terminology,
including, but not limited to, "may," "could," "seek," "guidance," "predict,"
"potential," "likely," "believe," "will," "expect," "anticipate," "estimate,"
"plan," "intend," "forecast," or variations of these terms and similar
expressions, or the negative of these terms or similar expressions. Forward-
looking statements contained in this press release are based on information
presently available to LivaNova and assumptions that the Company believes to be
reasonable, but are inherently uncertain. As a result, our actual results,
performance or achievements may differ materially from those expressed or
implied by these forward-looking statements, which are not guarantees of future
performance and involve known and unknown risks, uncertainties and other factors
that are, in some cases, beyond the Company's control. Investors are cautioned
that all such statements involve risks and uncertainties, including without
limitation, statements concerning developing novel opportunities in heart
failure, sleep apnea and percutaneous mitral valve, creating new innovative
solutions that benefit patients, healthcare professionals, and healthcare
systems, and building significant shareholder value. Important factors that may
cause actual results to differ include, but are not limited to: (i) risks that
the businesses of Cyberonics and Sorin (together, the "combined companies") will
not be integrated successfully or that the combined companies will not realize
estimated cost savings, value of certain tax assets, synergies and growth, or
that such benefits may take longer to realize than expected; (ii) the inability
of LivaNova to meet expectations regarding the timing, completion and accounting
of tax treatments; (iii) risks relating to unanticipated costs of integration,
including operating costs, customer loss or business disruption being greater
than expected; (iv) our organizational and governance structure; (v) reductions
in customer spending, a slowdown in customer payments and changes in customer
demand for products and services; (vi) unanticipated changes relating to
competitive factors in the industries in which LivaNova operates; (vii) the
ability to hire and retain key personnel; (viii) the ability to attract new
customers and retain existing customers in the manner anticipated; (ix) the
reliance on and integration of information technology systems; (x) changes in
legislation or governmental regulations affecting LivaNova; (xi) international,
national or local economic, social or political conditions that could adversely
affect LivaNova, its partners or its customers; (xii) conditions in the credit
markets; (xiii) business and other financial risks inherent to the industries in
which LivaNova operates; (xiv) risks associated with assumptions made in
connection with critical accounting estimates and legal proceedings; (xv)
LivaNova's international operations, which are subject to the risks of currency
fluctuations and foreign exchange controls; (xvi) and the potential of
international unrest, economic downturn or effects of currencies, tax
assessments, tax adjustments, anticipated tax rates, raw material costs or
availability, benefit or retirement plan costs, or other regulatory compliance
costs. The foregoing list of factors is not exhaustive. You should carefully
consider the foregoing factors and the other risks and uncertainties that affect
the parties' businesses, including those described in the "Risk Factors" section
of the Registration Statement on Form S-4, Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents
filed from time to time with the United States Securities and Exchange
Commission by LivaNova. LivaNova does not give any assurance (1) that LivaNova
will achieve its expectations, or (2) concerning any result or the timing
thereof, in each case, with respect to any regulatory action, administrative
proceedings, government investigations, litigation, warning letters, consent
decree, cost reductions, business strategies, earnings or revenue trends or
future financial results.
All information in this press release is as of the date of its release. The
Company does not undertake or assume any obligation to update publicly any of
the forward-looking statements in this press release to reflect actual results,
new information or future events, changes in assumptions or changes in other
factors affecting forward-looking statements, except to the extent required by
applicable law. If we update one or more forward-looking statements, no
inference should be drawn that we will make additional updates with respect to
those or other forward-looking statements. We caution you not to place undue
reliance on any forward-looking statements, which are made only as of the date
of this press release.
For more information, please visit www.livanova.com, or contact:
Investor Relations: Investor Relations and Media:
Vivid Sehgal Greg Browne
Chief Financial Officer Senior Vice President, Finance
Phone: +44 (0)203 786 5281 Phone: +1 (281) 228-7262
Fax: +44 (0)203 786 5291 Fax: +1 (281) 218-9332
e-mail: e-mail:
investor.relations(at)livanova.com corporate.communications(at)livanova.com
LivaNova PLC
THIRD QUARTER RECONCILIATION OF WORLDWIDE GROWTH TO COMPARABLE CONSTANT CURRENCY GROWTH
((1) (2))
(U.S. $ in thousands)
Proforma Currency Comparable
LivaNova Proforma Impact on Constant
Third
Quarter Historical Period Currency
2015 Sorin Cyberonics Sales Growth Sales Growth
------------------------------------------------------------------------
Three Thirteen
months weeks
ended ended
September September
30, 25,
2015 2015
-----------------------
Cardiac Surgery 145,737 145,737 161,770 -9.9% 16,621 0.4%
CRM 53,666 53,666 80,423 -33.3% 9,199 -21.8%
Neuromodulation 84,405 84,405 73,185 15.3% 1,485 17.4%
Other 716 716 - 835 - 138 -
------------------------------------------------------------------------
TOTAL $ 284,525 $ 200,119 $ 84,405 $ 316,212 -10.0% $ 27,443 -1.3%
------------------------------------------------------------------------
((1)) Management believes that referring to constant currency growth rates is a more
appropriate way to evaluate operational performance. Constant currency growth, a non-
GAAP financial measure, measures the change in sales between current and prior year
periods using average foreign exchange rates during the corresponding prior year
period.
((2) )The sales results presented are
unaudited.
LivaNova PLC
NINE MONTHS RECONCILIATION OF WORLDWIDE GROWTH TO COMPARABLE CONSTANT CURRENCY GROWTH
((1) (2))
(U.S. $ in thousands)
Proforma
LivaNova Currency Comparable
Nine Proforma Impact on Constant
Months Historical Period Currency
2015 Sorin Cyberonics Sales Growth Sales Growth
------------------------------------------------------------------------
Nine Thirty-
months nine weeks
ended ended
September September
30, 25,
2015 2015
-----------------------
Cardiac Surgery 450,001 450,001 493,513 -8.8% 55,947 2.5%
CRM 198,981 198,981 249,452 -20.2% 37,489 -5.2%
Neuromodulation 233,189 233,189 216,589 7.7% 5,284 10.1%
Other 2,134 2,134 - 2,507 461
------------------------------------------------------------------------
TOTAL $ 884,305 $ 651,116 $ 233,189 $ 962,061 -8.1% $ 99,181 2.2%
------------------------------------------------------------------------
((1)) Management believes that referring to constant currency growth rates is a more
appropriate way to evaluate operational performance. Constant currency growth, a non-
GAAP financial measure, measures the change in sales between current and prior year
periods using average foreign exchange rates during the corresponding prior year
period.
((2)) The sales results presented are unaudited.
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: LivaNova plc via GlobeNewswire
[HUG#1966329]
Datum: 12.11.2015 - 13:00 Uhr
Sprache: Deutsch
News-ID 434171
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contact information:
Town:
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