Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), parent company
of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the
development, manufacture and commercialization of innovative diagnostic
imaging agents and products, today reported financial results for its
second quarter ended June 30, 2018.
Management Comments“We posted solid results in the second
quarter, with revenue that was in line with expectations and Adjusted
EBITDA that exceeded our guidance,” said Mary Anne Heino, President and
CEO. “This year continues to be a period of strategic investment in our
business as we follow our three-pronged strategy of growing our
microbubble franchise, investing in our product pipeline, and pursuing
external opportunities that fit our growth and profitability objectives.”
Ms. Heino continued, “Our flagship product DEFINITY is the cornerstone
of our microbubble franchise and remains the leading echo contrast agent
worldwide. It is also a strong growth business for us, with worldwide
sales that grew 14.9% year on year. Amid increased interest in the use
of microbubbles in therapeutic and additional diagnostic applications,
our research and development efforts are focused on identifying new
applications and enhancing current applications to deliver future growth
opportunities.”
“Highlights from our busy second quarter include being granted a
composition of matter patent for an alternative formulation for DEFINITY
that will run through 2035. Also, we are on track to initiate our Phase
3 clinical program for a Left Ventricular Ejection Fraction, or LVEF,
indication for DEFINITY by the end of this year. At the same time, our
DEFINITY China program completed patient enrollment for its cardiac,
kidney, liver and pharmacokinetic studies, and we expect the application
to be submitted to the China FDA by the end of this year,” added Ms.
Heino.
Supplier UpdateAs previously disclosed, one of the
Company’s nuclear product suppliers, NTP, has been offline since early
June, resulting in a temporary disruption in the supply of
molybdenum-99, the medical isotope used in the Company’s TechneLite®
generators. NTP is working with its regulatory authority to resume
operations and in the meantime the Company is focused on mitigating the
supply disruption through sourcing additional molybdenum-99 from its
other suppliers.
Financial HighlightsThe Company’s worldwide revenues for
the second quarter of 2018 totaled $85.6 million, compared with $88.8
million for the second quarter of 2017, which included a $5.0 million
up-front payment received from GE Healthcare. DEFINITY had worldwide
revenues of $46.1 million for the second quarter, an increase of 14.9%
from the year-ago period.
Net income for the second quarter of 2018 totaled $9.7 million, or $0.25
per diluted share, compared with $13.6 million, or $0.35 per diluted
share, for the second quarter of 2017. The Company’s second quarter 2018
Adjusted EBITDA (as outlined in the GAAP to non-GAAP reconciliation
provided below) was $23.7 million, or 27.6% of revenues, compared with
$27.9 million, or 31.5% of revenues, for the second quarter of 2017.
OutlookFor the third quarter of 2018, the Company expects
worldwide revenues in the range of $82 million to $86 million. The
Company expects Adjusted EBITDA, as described in the GAAP to non-GAAP
reconciliation provided later in this release, of $18 million to $21
million, representing 20.9% to 25.6% of anticipated worldwide revenues.
The Company maintains its guidance for full year 2018 worldwide revenues
of approximately $337 million to $342 million, compared with $326.4
million in 2017 (which excludes the aforementioned $5.0 million payment
from GE Healthcare). The Company also maintains its guidance for full
year 2018 Adjusted EBITDA of $85 million to $90 million, representing
24.9% to 26.7% of anticipated worldwide revenues.
The Company’s guidance for worldwide revenues and Adjusted EBITDA are
forward-looking statements. They are subject to various risks and
uncertainties that could cause the Company’s actual results to differ
materially from guidance. Forward-looking statements are not predictions
of the Company’s actual performance. See the cautionary information
about forward-looking statements in the “Safe-Harbor Statement” section
of this press release.
Internet Posting of InformationThe Company routinely posts
information that may be important to investors in the “Investors”
section of its website at http://www.lantheus.com/.
The Company encourages investors and potential investors to consult its
website regularly for important information about the Company.
Conference Call and WebcastAs previously announced, the
Company will host a conference call starting at 4:30 p.m. Eastern Time
today. To access the live conference call via telephone, please dial
1-866-498-8390 (U.S. callers) or 1-678-509-7599 (international callers)
and provide passcode 8685099. A live audio webcast of the call also will
be available in the Investors section of the Company’s website at www.lantheus.com.
A replay of the audio webcast will be available in the Investors section
of our website at www.lantheus.com
approximately two hours after completion of the call and will be
archived for 30 days.
The conference call will include a discussion of non-GAAP financial
measures. Reference is made to the most directly comparable GAAP
financial measures, the reconciliation of the differences between the
two financial measures, and the other information included in this press
release, our Form 8-K filed with the SEC today, or otherwise available
in the Investor Relations section of our website located at www.lantheus.com.
The conference call may include forward-looking statements. See the
cautionary information about forward-looking statements in the
safe-harbor section of this press release.
About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.Lantheus
Holdings, Inc. is the parent company of LMI, a global leader in the
development, manufacture and commercialization of innovative diagnostic
imaging agents and products. LMI provides a broad portfolio of products,
including the echocardiography contrast agent DEFINITY® Vial for
(Perflutren Lipid Microsphere) Injectable Suspension; TechneLite®
(Technetium Tc99m Generator), a technetium-based generator that provides
the essential medical isotope used in nuclear medicine procedures; and
Xenon (Xenon Xe 133 Gas), an inhaled radiopharmaceutical imaging agent
used to evaluate pulmonary function and for imaging the lungs. The
Company is headquartered in North Billerica, Massachusetts with offices
in Puerto Rico and Canada. For more information, visit www.lantheus.com.
Non-GAAP Financial MeasuresThe Company uses non-GAAP
financial measures, such as revenues excluding the impact of foreign
currency; adjusted operating income; adjusted net income and its line
components; Adjusted EBITDA; adjusted net income per share – diluted;
and free cash flow. The Company’s management believes that the
presentation of these measures provides useful information to investors.
These measures may assist investors in evaluating the Company’s
operations, period over period. The measures may exclude such items
which may be highly variable, difficult to predict and of a size that
could have substantial impact on the Company’s reported results of
operations for a period. Management uses these and other non-GAAP
measures internally for evaluation of the performance of the business,
including the allocation of resources and the evaluation of results
relative to employee performance compensation targets. Investors should
consider these non-GAAP measures only as a supplement to, not as a
substitute for or as superior to, measures of financial performance
prepared in accordance with GAAP.
Safe Harbor for Forward-Looking and Cautionary StatementsThis
press release contains “forward-looking statements” as defined under
U.S. federal securities laws, including statements about our 2018
outlook. Forward-looking statements may be identified by their use of
terms such as anticipate, believe, confident, could, estimate, expect,
intend, may, plan, predict, project, target, will and other similar
terms. Such forward-looking statements are subject to risks and
uncertainties that could cause actual results to materially differ from
those described in the forward- looking statements. Readers are
cautioned not to place undue reliance on the forward-looking statements
contained herein, which speak only as of the date hereof. The Company
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future developments
or otherwise, except as may be required by law. Risks and uncertainties
that could cause our actual results to materially differ from those
described in the forward-looking statements are discussed in our filings
with the Securities and Exchange Commission (including those described
in the Risk Factors section in our Annual Reports on Form 10-K and our
Quarterly Reports on Form 10-Q). This press release includes
forward-looking non-GAAP guidance for 2018 Adjusted EBITDA. No
reconciliation of this forward-looking non-GAAP guidance was included in
this press release because, due to the high variability and difficulty
in making accurate forecasts and projections of some of the excluded
information and the fact that some of the excluded information is not
readily ascertainable or accessible, the Company is unable to quantify
certain amounts that would be required to be included in the most
directly comparable GAAP financial measure without unreasonable efforts.
Lantheus Holdings, Inc.
Consolidated Statements of Operations
(in thousands, except per share data – unaudited)
Lantheus Holdings, Inc.
Consolidated Segment Revenues Analysis
(in thousands – unaudited)
United States
International
Worldwide
Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands – unaudited)
Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands, except per share data – unaudited)
(a) The income tax effect of the adjustments between GAAP net income and
non-GAAP adjusted net income takes into account the tax treatment and
related tax rate that apply to each adjustment in the applicable tax
jurisdiction.
(b) During the fourth quarter of 2017, we released the valuation
allowance previously recorded against our domestic net deferred tax
assets. As a result, we included the tax effect of non-GAAP adjustments
starting in the fourth quarter of 2017. Presentation of 2017 Adjusted
Net Income has been modified to allow better go-forward comparability by
including the tax effect of non-GAAP reconciling items.
Lantheus Holdings, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(in thousands – unaudited)
(a) Represents income tax expense, less tax indemnification income
associated with BMS.
(b) Represents non-cash losses incurred associated with inventory and
other write-offs of long-lived assets.
(c) The amounts consist of severance and recruitment costs related to
employees, executives and directors.
(d) Represents offering costs incurred on behalf of certain shareholders
pursuant to a registration rights agreement and other non-recurring
costs.
(e) Represents internal and external costs associated with establishing
new manufacturing sources for our commercial and clinical candidate
products.
Lantheus Holdings, Inc.
Reconciliation of Free Cash Flow
(in thousands – unaudited)
Lantheus Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands – unaudited)
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