News Release
Mallinckrodt plc Reports Fourth-Quarter and Fiscal 2013 Financial Results
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Fourth-quarter net sales of $552 million, up 8.2% on an
operational growth basis(1)
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Fourth-quarter adjusted diluted earnings per share of $1.02
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Full-year net sales of $2.2 billion, up 8.2% on an operational
growth basis(1)
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Full-year adjusted diluted earnings per share of $3.17
DUBLIN--(BUSINESS WIRE)--Nov. 7, 2013--
Mallinckrodt plc (NYSE: MNK), a global specialty pharmaceutical and
medical imaging business, today reported results for the fourth quarter
of fiscal 2013, which ended September 27, 2013.
Net sales were $552.2 million for the fourth quarter of fiscal 2013, an
increase of 7.6%, compared with $513.1 million reported in the fourth
quarter of fiscal 2012. Operational growth was 8.2% as movements in
foreign exchange rates negatively impacted net sales.
On a non-GAAP basis, adjusted net income(1) for the fourth
fiscal quarter of 2013 was $59.1 million, compared with $40.6 million a
year ago. Non-GAAP adjusted diluted earnings per share were $1.02,
compared with $0.70 in the same quarter a year ago.
On a GAAP basis, net income for the fourth quarter of fiscal 2013 was
$35.8 million, or $0.62 per share, compared with $26.2 million, or $0.45
per share, in the year-ago period. The increase in net income reflects
increased net sales and profits in the Specialty Pharmaceuticals
segment, lower separation costs following the June 28, 2013, spin-off
from the company’s former parent and a lower effective tax rate that
reflects Mallinckrodt’s structure as an independent company. These
results were partially offset by restructuring charges incurred in the
quarter and increased research and development (R&D) costs as products
progress through the pipeline.
“Our strong fourth-quarter and full-year results reflect Mallinckrodt’s
continued focus on positioning the business as a leading specialty
pharmaceuticals company,” said Mark Trudeau, President and CEO of
Mallinckrodt. “Our Specialty Pharmaceuticals segment posted strong
increases in net sales and operating income, benefiting from
higher-margin products in our Brands and Generics portfolios. Looking
forward, we are optimistic that successful development of our pipeline
will result in launching important new drugs in the market, further
driving Specialty Pharmaceuticals segment growth over the long term. We
are also fully committed to increasing profitability through
company-wide operating efficiencies and growth plans that include
targeted international markets.”
Gross profit was $258.3 million for the fourth quarter of fiscal 2013,
compared with $233.3 million in the prior-year period, representing an
increase of 10.7%. Gross profit, as a percentage of net sales, was 46.8%
for the quarter, versus 45.5%.
Selling, general and administrative (SG&A) expenses for the fourth
quarter of fiscal 2013 were $137.0 million, compared with $140.4 million
in the same period in 2012, a decrease of 2.4%. The decrease was
attributable to tight expense controls and benefits from ongoing
restructuring initiatives. SG&A expenses as a percentage of net sales
were 24.8% in the fourth fiscal quarter of 2013, compared with 27.4% in
the prior year.
R&D expenses for the fourth quarter of fiscal 2013 were $44.1 million,
compared with $36.6 million in the prior-year period. The increase in
R&D reflects a $5.0 million milestone payment related to the acceptance
of the MNK-795 New Drug Application (NDA) for priority review with the
U.S. Food and Drug Administration (FDA) and the company’s continued
investment in building a pipeline of new products, including advancing
its brand pain product MNK-155 and its intrathecal and generics
portfolios.
Separation costs for the fourth quarter of fiscal 2013 were $3.6
million, compared with $8.1 million in the prior-year quarter.
Separation costs decreased following the spin-off from the company’s
former parent.
Restructuring charges were $15.3 million for the fourth quarter of
fiscal 2013, compared with $0.7 million in the prior-year quarter. The
increase primarily reflects activities under the previously announced
$100 million to $125 million restructuring program.
Fourth-quarter adjusted EBITDA(1) was $120.3 million, versus
$90.5 million for the prior-year period. The increase in adjusted EBITDA
reflects higher net sales and profits from the Specialty Pharmaceuticals
segment. As a percentage of net sales, adjusted EBITDA in the fourth
quarter of fiscal 2013 was 21.8%, compared with 17.6% in the prior-year
period.
The fourth-quarter fiscal 2013 effective tax rate of 29.9%, or 27.1% on
a non-GAAP basis, is calculated on a stand-alone company basis. The
43.5% tax rate for the prior-year period was calculated on a carve-out
basis of accounting, reflecting the business as historically managed as
part of the former parent.
Full-Year Fiscal 2013 Results
For full-year fiscal 2013, net sales were $2.2 billion, compared with
$2.1 billion in the prior year, which represents an increase of 7.6%.
Operational growth was 8.2% as movements in foreign exchange rates
negatively impacted net sales. The company’s Specialty Pharmaceuticals
segment recorded strong growth of 22.2%.
On a GAAP basis, net income for full-year fiscal 2013 decreased to $61.1
million, compared with $134.6 million for the same period in 2012. GAAP
earnings per share were $1.06, compared with $2.33 last year.
On a non-GAAP basis, adjusted net income was $183.0 million, compared
with $196.3 million last year. Non-GAAP adjusted diluted earnings per
share were $3.17, compared with $3.40 last year. Full-year fiscal 2013
adjusted EBITDA was $400.6 million, versus $402.8 million in the prior
year, a decrease of 0.5%. This reflects the increased net sales and
profits from the Specialty Pharmaceuticals segment, offset primarily by
the impact from higher raw material costs in the Global Medical Imaging
segment and higher R&D spending. As a percentage of net sales, adjusted
EBITDA for full-year fiscal 2013 was 18.1%, compared with 19.6% last
year.
BUSINESS SEGMENT RESULTS
Specialty Pharmaceuticals Segment
Net sales in the Specialty Pharmaceuticals segment for the fourth
quarter of fiscal 2013 were $311.4 million, an increase of 20.3%,
compared with $258.9 million in the prior-year period. Operational
growth was 20.8%. Net sales in Brands were $53.9 million, compared with
$39.6 million last year, led by net sales from EXALGO®
(hydromorphone HCl) Extended-Release Tablets, CII, and the intrathecal
product portfolio acquired in fiscal 2013. Net sales in Generics and
Active Pharmaceutical Ingredients (API) were $257.5 million, compared
with $219.3 million last year, primarily driven by net sales from
Methylphenidate HCl Extended-Release Tablets, USP CII (Methylphenidate
ER) offset by timing shifts in net sales of the broader Generics and API
portfolio.
Segment operating income in the quarter was $81.9 million, compared with
$34.5 million last year. Segment operating margin was 26.3%, compared
with 13.3% last year, reflecting growth in higher-margin product lines
and portfolio additions, as well as operating leverage due to strong
sales growth. Highlights for the quarter include the following:
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Net sales of EXALGO were $30.7 million, compared with $28.3 million
last year, up 8.5% over the fourth fiscal quarter of 2012, largely
attributable to the launch of the 32mg dosage strength in September
2012. Full-year fiscal 2013 net sales totaled $122.9 million.
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Net sales of Methylphenidate ER were $63.0 million in the fourth
fiscal quarter, with $151.3 million for the year. Net sales during the
fourth fiscal quarter of 2013 reflected strong customer reorders
following consumption of initial product launch quantities.
Global Medical Imaging Segment
Net sales in the company’s Global Medical Imaging segment were $229.0
million, versus $242.8 million in the fourth quarter of fiscal 2012. Net
sales of Contrast Media and Delivery Systems (CMDS) were $119.6 million,
compared with $132.7 million in the prior year, due to continuing
commoditization in mature markets such as the United States and Western
Europe. Nuclear Imaging net sales were essentially flat at $109.4
million compared with $110.1 million in the prior year.
For the fiscal fourth quarter, operating income in the segment was $30.0
million, compared with $53.6 million last year. Operating margin was
13.1%, compared with 22.1% last year, reflecting the negative impact of
higher raw material and production costs in Global Medical Imaging in
addition to lower net sales.
FISCAL 2014 OUTLOOK
Guidance: Mallinckrodt provided guidance for fiscal 2014 on
October 16, 2013, which is summarized below. Amounts presented assume
foreign currency exchange rates consistent with those in fiscal 2013.
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Adjusted diluted earnings per share of $2.45 to $2.65
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Total Mallinckrodt net sales of $2.15 billion to $2.25 billion
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Specialty Pharmaceuticals segment net sales of $1.22 billion to $1.27
billion
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Global Medical Imaging segment net sales of $885 million to $930
million
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Methylphenidate ER net sales of at least $120 million
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Non-GAAP effective tax rate of 26% to 29%
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Capital expenditures in the range of $140 million to $160 million
CONFERENCE CALL AND WEBCAST
Mallinckrodt will hold a conference call for investors on Thursday,
November 7, 2013, beginning at 8:30am/U.S. Eastern Standard Time. This
call can be accessed in three ways:
At Mallinckrodt’s website: http://investor.mallinckrodt.com.
By telephone: For both “listen-only” participants and those participants
who wish to take part in the question-and-answer portion of the call,
the telephone dial-in number in the U.S. is 877-703-6107. For
participants outside the U.S., the dial-in number is 857-244-7306. The
access code for all callers is 20619575.
Through an audio replay: A replay of the call will be available
beginning at 12:30pm/U.S. Eastern Standard Time on November 7, 2013, and
ending at 12:59am/U.S. Eastern Standard Time on November 15, 2013. The
dial-in number for U.S. participants is 888-286-8010. For participants
outside the U.S., the replay dial-in number is 617-801-6888. The replay
access code for all callers is 67136812.
ABOUT MALLINCKRODT
Mallinckrodt is a global specialty pharmaceuticals business that
develops, manufactures, markets and distributes specialty pharmaceutical
products and medical imaging agents. The company’s Specialty
Pharmaceuticals segment includes branded and generic drugs, and the
Global Medical Imaging segment includes contrast media and nuclear
imaging agents. Mallinckrodt has approximately 5,500 employees worldwide
with sales in roughly 70 countries. To learn more about Mallinckrodt,
please visit www.mallinckrodt.com.
(1) NON-GAAP FINANCIAL MEASURES
This press release contains financial measures, including adjusted net
income, adjusted diluted earnings per share, adjusted EBITDA and
operational growth, which are considered “non-GAAP” financial measures
under applicable Securities and Exchange Commission rules and
regulations.
Adjusted net income represents net income, prepared in accordance with
accounting principles generally accepted in the U.S. (GAAP), excluding
the after-tax effects related to separation costs; restructuring and
related charges, net; amortization and discontinued operations. Adjusted
diluted earnings per share represents adjusted net income divided by the
number of diluted shares.
Adjusted EBITDA represents GAAP net income before net interest, income
taxes, depreciation and amortization, adjusted to exclude certain items.
These items, if applicable, include discontinued operations; other
income, net; separation costs; restructuring charges, net; immediately
expensed up-front and milestone payments; acquisition-related costs; and
non-cash impairment charges.
Operational growth measures the change in net sales between current- and
prior-year periods using a constant currency, the exchange rate in
effect during the applicable prior-year period. This measure is one of
the performance metrics that determines management incentive
compensation.
The company has provided these non-GAAP financial measures because they
are used by management, along with financial measures in accordance with
GAAP, to evaluate the company’s operating performance. In addition, the
company believes that they will be used by certain investors to measure
Mallinckrodt’s operating results. Management believes that presenting
these non-GAAP measures provides useful information about the company’s
performance across reporting periods on a consistent basis by excluding
items that the company does not believe are indicative of its core
operating performance.
These non-GAAP measures should be considered supplemental to and not a
substitute for financial information prepared in accordance with GAAP.
The company’s definition of these non-GAAP measures may differ from
similarly titled measures used by others.
Because non-GAAP financial measures exclude the effect of items that
will increase or decrease the company’s reported results of operations,
management strongly encourages investors to review the company’s
consolidated financial statements and publicly filed reports in their
entirety. A reconciliation of the non-GAAP financial measures to the
most directly comparable GAAP financial measures is included in the
tables accompanying this release.
FORWARD-LOOKING STATEMENTS
Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include, but are not limited to, statements
about future financial condition and operating results, economic,
business, competitive and/or regulatory factors affecting our business.
Any forward-looking statements contained herein are based on our
management’s current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the U.S. Drug Enforcement
Administration, our ability to obtain and/or timely transport
molybdenum-99 to our technetium-99m generator production facilities,
customer concentration, cost-containment efforts of customers,
purchasing groups, third-party payors and governmental organizations,
our ability to successfully develop or commercialize new products, our
ability to protect intellectual property rights, competition, our
ability to integrate acquisitions of technology, products and
businesses, product liability losses and other litigation liability, the
reimbursement practices of a small number of large public or private
issuers, complex reporting and payment obligation under healthcare
rebate programs, changes in laws and regulations, conducting business
internationally, foreign exchange rates, material health, safety and
environmental liabilities, litigation and violations and information
technology infrastructure. These and other factors are identified and
described in more detail in the “Risk Factors” section of the Form 10
Registration Statement, as amended. We disclaim any obligation to update
these forward-looking statements other than as required by law.

Source: Mallinckrodt plc
Mallinckrodt plc
John Moten, 314-654-6650
Vice President,
Investor Relations
john.moten@mallinckrodt.com
or
Lynn
Phillips, 314-654-3263
Manager, Media Relations
lynn.phillips@mallinckrodt.com
or
Meredith
Fischer, 314-654-3318
Senior Vice President, Communications
meredith.fischer@mallinckrodt.com