HAYWARD, Calif.--(BUSINESS WIRE)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today reported
first quarter 2013 adjusted net income of $25.3 million or $0.37 per
diluted share, compared to $35.8 million or $0.53 per diluted share in
the first quarter 2012. GAAP net income for the first quarter 2013 was
$105.4 million or $1.55 per diluted share, compared to $12.4 million or
$0.18 per diluted share in the prior year period.
For the first quarter 2013, total revenues were $148.5 million, an
increase of 15%, compared to $128.6 million in the prior year period.
The increase was due to United States (U.S.) sales of Zomig® and sales
from the January 4, 2013, launch of generic oxymorphone hydrochloride
extended-release tablets, for which there was no comparable amount for
either product in the prior year period, partially offset by lower sales
of the Company’s authorized generic Adderall XR® products as a result of
additional generic competition.
Cash and short-term investments increased $50.1 million to $349.0
million as of March 31, 2013, compared to $298.9 million as of December
31, 2012, primarily due to the receipt of a one-time pre-tax payment of
$48.0 million in connection with the settlement of litigation as
described below. On April 18, 2013, the Company received a one-time
pre-tax payment of $102.0 million from Endo Pharmaceuticals, Inc. (Endo)
under a previously announced agreement. The payment is recorded as a
receivable as of March 31, 2013 and is not reflected in the first
quarter 2013 cash and cash equivalents balance.
Adjusted earnings before interest, taxes, depreciation and amortization
(Adjusted EBITDA), was $43.4 million in the first quarter 2013, compared
to $62.1 million in the first quarter 2012.
The adjusted results in the first quarter 2013 primarily reflect the
removal of the following pre-tax items:
-
The receipt of $102.0 million from Endo in connection with a
previously announced settlement and license agreement.
-
The receipt of $48.0 million from Shire LLC (Shire) in connection with
the settlement of litigation relating to supply of authorized generic
Adderall XR products to the Company under the terms of the License and
Supply Agreement with Shire (Shire Agreement).
-
Total charges of $18.1 million, including an inventory reserve on
discontinued products ($6.7 million), as further described below, and
a reserve of pre-launch inventory for RYTARYTM ($5.0
million) and other generic products ($6.4 million) as a result of the
delay in the anticipated regulatory approvals.
-
A charge of $7.1 million for amortization and acquisition costs from
third-party business development transactions.
The adjusted results in the first quarter 2012 primarily reflect the
removal of the following pre-tax items:
-
The receipt of the gross profit of $30.0 million earned from U.S.
Zomig sales pursuant to the License Agreement with AstraZeneca UK
Limited (AstraZeneca Agreement).
-
A charge of $5.2 million relating to an inventory adjustment as a
result of a change in the strategic direction of certain generic
products.
Please refer to the attached “Non-GAAP Financial Measures” for a
reconciliation of GAAP to non-GAAP items.
In the first quarter 2013, the Company recorded an inventory reserve of
$6.7 million as stated above. This charge was the result of a strategic
review conducted by the Company with a third party consulting firm of
the Company’s currently manufactured generic product portfolio. This
review was completed during the first quarter 2013 and the Company
decided to discontinue manufacturing a number of low-sales/low-margin
mature products. The total net sales of these products in 2012 were less
than 3% of the total Company product revenues, with minimal impact on
net income. The Company is currently reviewing manufacturing costs and
expects that the discontinuation of these products and other
efficiencies will result in cost savings of approximately $10.0 million
for the full year 2013, which has been reflected in the revised full
year gross margin guidance.
“We expect that this decision will improve operating efficiencies and
ensures that resources are allocated and aligned with our strategic
growth priorities,” said Larry Hsu, Ph.D., president and CEO, Impax
Laboratories, Inc. “We will continue to look for opportunities to free
up resources that can be invested to best position Impax for a strong
future.”
“On March 21, 2013, we submitted our responses to the recent Form 483 to
the FDA and have requested a meeting with the San Francisco District
Office to ensure that our plan and actions are in alignment with the
FDA’s expectations. We expect to incur $10.0 million to $15.0 million in
remediation costs during fiscal year 2013. While we have implemented
numerous improvements across our manufacturing and quality operations
over the past two years, we remain committed to resolving all
observations and exceeding current Good Manufacturing Practices,”
concluded Dr. Hsu.
Business Segment Information
The Company has two reportable segments, the Global Pharmaceuticals
Division (generic products & services) and the Impax Pharmaceuticals
Division (brand products & services) and does not allocate general
corporate services to either segment.
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Global Pharmaceuticals Division Information
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(unaudited, amounts in thousands)
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Three Months Ended
March 31,
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2013
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2012
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Revenues:
|
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Global Product sales, net
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$
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97,785
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$
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116,211
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Rx Partner
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3,114
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|
2,978
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Other revenues
|
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|
737
|
|
|
4,076
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Total revenues
|
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101,636
|
|
|
123,265
|
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Cost of revenues
|
|
|
61,444
|
|
|
63,106
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Gross profit
|
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40,192
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|
60,159
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Operating expenses:
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|
|
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Research and development
|
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11,711
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10,673
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Patent litigation
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|
4,278
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|
|
4,038
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Selling, general and administrative
|
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5,043
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|
4,317
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Total operating expenses
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21,032
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|
|
19,028
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Income from operations
|
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$
|
19,160
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$
|
41,131
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In the first quarter 2013, Global Product sales, net, were $97.8
million, compared to $116.2 million in the prior year period. The
decline was primarily due to lower sales of authorized generic Adderall
XR products as a result of additional generic competition, partially
offset by the January 4, 2013, launch of oxymorphone hydrochloride
extended-release tablets.
Other revenues in the first quarter 2013 were $0.7 million, compared to
$4.1 million in the prior year period. The decline is primarily the
result of the extension of the revenue recognition period for the Joint
Development Agreement with Valeant Pharmaceuticals International, Inc.
(formerly Medicis Pharmaceutical Corporation) from November 2013 to
December 2014 due to changes in the estimated timing of completion of
certain research and development activities.
Gross profit in the first quarter 2013 decreased to $40.2 million,
compared to $60.2 million in the prior year period. This decrease is
primarily due to lower sales of authorized generic Adderall XR products
and a $13.1 million inventory reserve for discontinued products and
other generic products as a result of the delay in the anticipated
regulatory approvals as described above. Gross margin in the first
quarter 2013 decreased to 40%, compared to 49% in the prior year period,
primarily due to the inclusion of the $13.1 million inventory charge in
cost of revenues as described above.
Total Global Pharmaceuticals operating expenses in the first quarter
2013 increased to $21.0 million, compared to $19.0 million in the prior
year period, with such difference primarily due to a $2.0 million
milestone payment to a research and development partner.
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Impax Pharmaceuticals Division Information
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(unaudited, amounts in thousands)
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Three Months Ended
March 31,
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2013
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2012
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Revenues:
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Impax Product sales, net
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$
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46,521
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$
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-
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Other revenues
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332
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5,303
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Total revenues
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46,853
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5,303
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Cost of revenues
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29,174
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|
2,909
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Gross profit
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17,679
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|
|
2,394
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Operating expenses:
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Research and development
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7,894
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8,143
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Selling, general and administrative
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12,764
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|
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3,061
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Total operating expenses
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20,658
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11,204
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Loss from operations
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$
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(2,979)
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$
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(8,810)
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In the first quarter 2013, Impax Product sales, net, were $46.5 million
as a result of U.S. sales of Zomig for which there was no comparable
amount in the prior year period. The U.S. patents on Zomig tablets and
orally disintegrating tablets expire on May 14, 2013. These two dosage
forms represent approximately 90% of the Company’s quarterly sales of
Zomig. As a result of the patent expiration, the Company expects generic
competition that will significantly impact future sales of these two
dosage forms. The Company is planning to launch authorized generic
versions of both products upon patent expiration. Impax Pharmaceuticals
will continue to commercialize the Zomig nasal spray which has U.S.
patents expiring as late as May 2021.
Other revenues in the first quarter 2013 declined to $0.3 million,
compared to $5.3 million in the prior year period. This decrease was due
to a $3.5 million decline in promotional partner revenues as the
Company’s detailing for Pfizer’s product Lyrica® ended on
June 30, 2012 and a $1.4 million decline related to the December 31,
2012 completion of the 24 month amortization period of the $11.5 million
up-front payment received under the License, Development and
Commercialization Agreement with Glaxo Group Limited.
Gross profit in the first quarter 2013 increased to $17.7 million,
compared to $2.4 million in the prior year period, primarily due to U.S.
Zomig sales. Gross margin in the first quarter 2013 decreased to 38%,
compared to 45% in the prior year period. The first quarter 2013 gross
margin was, however, negatively impacted by the inclusion in cost of
revenues of $6.7 million for amortization and acquisition-related costs
from the Zomig transaction and a $5.0 million charge for the reserve of
RYTARYTM pre-launch inventory as a result of the delay in the
anticipated regulatory approval. In addition, beginning January 1, 2013,
the Company paid AstraZeneca royalties on sales of Zomig under the terms
of the AstraZeneca Agreement.
Total Impax Pharmaceuticals operating expenses in the first quarter 2013
increased to $20.7 million, compared to $11.2 million in the prior year
period, primarily due to the expansion of the sales and marketing group
during the third and fourth quarters of 2012 to support the anticipated
launch of RYTARYTM.
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Corporate and Other
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(unaudited, amounts in thousands)
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Three Months Ended
March 31,
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2013
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2012
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General and administrative expenses
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$
|
11,910
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|
$
|
13,855
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|
Loss from operations
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$
|
(11,910)
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|
$
|
(13,855)
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General and administrative expenses in the first quarter 2013 decreased
to $11.9 million, compared to $13.9 million in the prior year period
primarily due to lower corporate legal fees.
2013 Financial Guidance
The Company updated its 2013 financial guidance as noted below.
-
UPDATED - Gross margins as a percent of total revenues are expected to
be in the mid 40% range.
-
Total R&D expenses across the generic and brand divisions of
approximately $87.0 million to $95.0 million; generic R&D expenses of
approximately $49.0 million to $53.0 million and brand R&D expenses of
approximately $38.0 million to $42.0 million.
-
Patent litigation expenses of approximately $10.0 million to $12.0
million.
-
SG&A expenses of approximately $115.0 million to $120.0 million.
-
Amortization expense of approximately $14.0 million. Approximate 2013
quarterly impact on cost of goods sold: first quarter $7.0 million,
second quarter $5.0 million, third quarter $1.0 million and fourth
quarter $1.0 million.
-
Effective tax rate of approximately 32% to 34%.
Conference Call Information
The Company will host a conference call on May 1, 2013 at 4:30 p.m. EDT
to discuss its results. The call can also be accessed via a live Webcast
through the Investor Relations section of the Company’s Web site, www.impaxlabs.com.
The number to call from within the United States is (877) 356-3814 and
(706) 758-0033 internationally. The conference ID is 32064217. A replay
of the conference call will be available shortly after the call for a
period of seven days. To access the replay, dial (855) 859-2056 (in the
U.S.) and (404) 537-3406 (international callers).
About Impax Laboratories, Inc.
Impax Laboratories, Inc. (Impax) is a technology based specialty
pharmaceutical company applying its formulation expertise and drug
delivery technology to the development of controlled-release and
specialty generics in addition to the development of central nervous
system disorder branded products. Impax markets its generic products
through its Global Pharmaceuticals division and markets its branded
products through the Impax Pharmaceuticals division. Additionally, where
strategically appropriate, Impax develops marketing partnerships to
fully leverage its technology platform and pursues partnership
opportunities that offer alternative dosage form technologies, such as
injectables, nasal sprays, inhalers, patches, creams and ointments. For
more information, please visit the Company's Web site at: www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are forward-looking
in nature and express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company’s
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
Company’s industry, business, financial position and results of
operations, fluctuations in revenues and operating income, the Company’s
ability to promptly correct the issues raised in the warning letter and
Form 483 observations received from the FDA, the Company’s ability to
successfully develop and commercialize pharmaceutical products in a
timely manner, reductions or loss of business with any significant
customer, the impact of consolidation of the Company’s customer base,
the impact of competition, the Company’s ability to sustain
profitability and positive cash flows, any delays or unanticipated
expenses in connection with the operation of the Company’s Taiwan
facility, the effect of foreign economic, political, legal and other
risks on the Company’s operations abroad, the uncertainty of patent
litigation, the increased government scrutiny on the Company’s
agreements with brand pharmaceutical companies, consumer acceptance and
demand for new pharmaceutical products, the impact of market perceptions
of the Company and the safety and quality of the Company’s products, the
difficulty of predicting FDA filings and approvals, the Company’s
ability to achieve returns on its investments in research and
development activities, the Company’s inexperience in conducting
clinical trials and submitting new drug applications, the Company’s
ability to successfully conduct clinical trials, the Company’s reliance
on third parties to conduct clinical trials and testing, impact of
illegal distribution and sale by third parties of counterfeits or stolen
products, the availability of raw materials and impact of interruptions
in the Company’s supply chain, the use of controlled substances in the
Company’s products, disruptions or failures in the Company’s information
technology systems and network infrastructure, the Company’s reliance on
alliance and collaboration agreements, the Company’s dependence on
certain employees, the Company’s ability to comply with legal and
regulatory requirements governing the healthcare industry, the
regulatory environment, the Company’s ability to protect its
intellectual property, exposure to product liability claims, changes in
tax regulations, the Company’s ability to manage growth, including
through potential acquisitions, the restrictions imposed by the
Company’s credit facility, uncertainties involved in the preparation of
the Company’s financial statements, the Company’s ability to maintain an
effective system of internal control over financial reporting, the
effect of terrorist attacks on the Company’s business, the location of
the Company’s manufacturing and research and development facilities near
earthquake fault lines and other risks described in the Company’s
periodic reports filed with the Securities and Exchange
Commission. Forward-looking statements speak only as to the date on
which they are made, and the Company undertakes no obligation to update
publicly or revise any forward-looking statement, regardless of whether
new information becomes available, future developments occur or
otherwise.
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Impax Laboratories, Inc.
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Consolidated Statements of Operations
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(unaudited, amounts in thousands, except share and per share
data)
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Three Months
Ended March 31,
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2013
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2012
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Revenues:
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|
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Global Pharmaceuticals Division
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$
|
101,636
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|
$
|
123,265
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Impax Pharmaceuticals Division
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|
46,853
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|
|
5,303
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Total revenues
|
|
|
148,489
|
|
|
128,568
|
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Cost of revenues
|
|
|
90,618
|
|
|
66,015
|
|
Gross profit
|
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|
57,871
|
|
|
62,553
|
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Operating expenses:
|
|
|
|
|
|
Research and development
|
|
|
19,605
|
|
|
18,816
|
|
Patent litigation
|
|
|
4,278
|
|
|
4,038
|
|
Selling, general and administrative
|
|
|
29,717
|
|
|
21,233
|
|
Total operating expenses
|
|
|
53,600
|
|
|
44,087
|
|
Income from operations
|
|
|
4,271
|
|
|
18,466
|
|
Other income (expense), net
|
|
|
149,456
|
|
|
(48)
|
|
Interest income
|
|
|
276
|
|
|
255
|
|
Interest expense
|
|
|
(283)
|
|
|
(39)
|
|
Income before income taxes
|
|
|
153,720
|
|
|
18,634
|
|
Provision for income taxes
|
|
|
48,278
|
|
|
6,269
|
|
Net income
|
|
$
|
105,442
|
|
$
|
12,365
|
|
|
|
|
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Net Income per share:
|
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|
|
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Basic
|
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$
|
1.59
|
|
$
|
0.19
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Diluted
|
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$
|
1.55
|
|
$
|
0.18
|
|
|
|
|
|
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Weighted average common shares outstanding:
|
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|
|
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Basic
|
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|
66,487,470
|
|
|
65,122,240
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Diluted
|
|
|
68,178,355
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67,907,263
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|
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Impax Laboratories, Inc.
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Condensed Consolidated Balance Sheets
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(unaudited, amounts in thousands)
|
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|
|
|
|
|
|
|
|
March 31,
|
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December 31,
|
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|
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2013
|
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2012
|
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Assets
|
|
|
|
|
|
Current assets:
|
|
|
|
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Cash and cash equivalents
|
|
$
|
197,577
|
|
$
|
142,162
|
|
Short-term investments
|
|
|
151,436
|
|
|
156,756
|
|
Accounts receivable, net
|
|
|
113,606
|
|
|
92,249
|
|
Other receivable
|
|
|
102,049
|
|
|
-
|
|
Inventory, net
|
|
|
82,090
|
|
|
89,764
|
|
Deferred income taxes
|
|
|
44,365
|
|
|
42,529
|
|
Prepaid expenses and other assets
|
|
|
7,804
|
|
|
22,083
|
|
Total current assets
|
|
|
698,927
|
|
|
545,543
|
|
Property, plant and equipment, net
|
|
|
176,963
|
|
|
180,758
|
|
Other assets
|
|
|
64,500
|
|
|
62,145
|
|
Intangible assets, net
|
|
|
40,809
|
|
|
47,950
|
|
Goodwill
|
|
|
27,574
|
|
|
27,574
|
|
Total assets
|
|
$
|
1,008,773
|
|
$
|
863,970
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
151,199
|
|
$
|
134,082
|
|
Accrued profit sharing and royalty expenses
|
|
|
22,553
|
|
|
4,936
|
|
Deferred revenue
|
|
|
4,452
|
|
|
6,277
|
|
Total current liabilities
|
|
|
178,204
|
|
|
145,295
|
|
Deferred revenue
|
|
|
7,074
|
|
|
6,362
|
|
Other liabilities
|
|
|
25,038
|
|
|
21,210
|
|
Total liabilities
|
|
|
210,316
|
|
|
172,867
|
|
Total stockholders' equity
|
|
|
798,457
|
|
|
691,103
|
|
Total liabilities and stockholders' equity
|
|
$
|
1,008,773
|
|
$
|
863,970
|
|
|
|
|
|
|
|
|
|
|
|
Impax Laboratories, Inc.
|
|
Consolidated Statements of Cash Flows
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(unaudited, amounts in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
|
2013
|
|
2012
|
|
Cash flows from operating activities:
|
|
|
|
|
|
Net income
|
|
$
|
105,442
|
|
$
|
12,365
|
|
Adjustments to reconcile net income to net cash provided by
operating activities:
|
|
|
|
|
|
Depreciation and amortization
|
|
|
12,397
|
|
|
3,730
|
|
Provision for inventory reserves
|
|
|
22,804
|
|
|
4,094
|
|
Accretion of interest income on short-term investments
|
|
|
(158)
|
|
|
(171)
|
|
Deferred income taxes (benefit)
|
|
|
(2,800)
|
|
|
817
|
|
Tax impact related to the exercise of employee stock options
|
|
|
3
|
|
|
(1,632)
|
|
Deferred revenue
|
|
|
-
|
|
|
315
|
|
Deferred product manufacturing costs
|
|
|
-
|
|
|
(495)
|
|
Recognition of deferred revenue
|
|
|
(1,113)
|
|
|
(6,061)
|
|
Amortization of deferred product manufacturing costs
|
|
|
-
|
|
|
661
|
|
Accrued profit sharing and royalty expense
|
|
|
22,541
|
|
|
25,555
|
|
Payments of profit sharing and royalty expense
|
|
|
(4,925)
|
|
|
(40,755)
|
|
Share-based compensation expense
|
|
|
4,359
|
|
|
3,809
|
|
Other receivable
|
|
|
(102,049)
|
|
|
-
|
|
Changes in assets and liabilities:
|
|
|
|
|
|
Accounts receivable
|
|
|
(21,357)
|
|
|
34,590
|
|
Inventory
|
|
|
(15,130)
|
|
|
(7,855)
|
|
Prepaid expenses and other assets
|
|
|
12,561
|
|
|
(3,745)
|
|
Accounts payable and accrued expenses
|
|
|
22,645
|
|
|
(4,153)
|
|
Other liabilities
|
|
|
2,527
|
|
|
2,661
|
|
Net cash provided by operating activities
|
|
|
57,747
|
|
|
23,730
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
Purchase of short-term investments
|
|
|
(60,515)
|
|
|
(35,585)
|
|
Maturities of short-term investments
|
|
|
65,993
|
|
|
126,549
|
|
Purchases of property, plant and equipment
|
|
|
(9,361)
|
|
|
(8,165)
|
|
Payment for product licensing rights
|
|
|
-
|
|
|
(25,000)
|
|
Net cash (used in) provided by investing activities
|
|
|
(3,883)
|
|
|
57,799
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
Proceeds from exercise of stock options and ESPP
|
|
|
1,554
|
|
|
4,468
|
|
Tax impact related to the exercise of employee stock options and
restricted stock
|
|
|
(3)
|
|
|
1,632
|
|
Net cash provided by financing activities
|
|
|
1,551
|
|
|
6,100
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
55,415
|
|
|
87,629
|
|
Cash and cash equivalents, beginning of period
|
|
|
142,162
|
|
|
104,419
|
|
Cash and cash equivalents, end of period
|
|
$
|
197,577
|
|
$
|
192,048
|
|
|
|
|
|
|
|
|
|
Impax Laboratories, Inc.
|
|
Non-GAAP Financial Measures
|
|
|
|
Total adjusted net income, adjusted net income per diluted share and
adjusted EBITDA are not measures of financial performance under
generally accepted accounting principles (GAAP) and should not be
construed as substitutes for, or superior to, GAAP net income, and
net income per diluted share as a measure of financial performance.
However, management uses both GAAP financial measures and the
disclosed non-GAAP financial measures internally to evaluate and
manage the Company’s operations and to better understand its
business. Further, management believes the inclusion of non-GAAP
financial measures provides meaningful supplementary information to
and facilitates analysis by investors in evaluating the Company’s
financial performance, results of operations and trends. The
Company’s calculation of adjusted net income, adjusted net income
per diluted share and adjusted EBITDA, may not be comparable to
similarly designated measures reported by other companies, since
companies and investors may differ as to what type of events warrant
adjustment.
|
|
|
|
The following table reconciles reported net income to adjusted net
income.
|
|
|
|
|
|
|
|
(Unaudited, amounts in millions, except per share data)
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
2012
|
|
Net income
|
|
$
|
105.4
|
|
$
|
12.4
|
|
Adjusted to add (deduct):
|
|
|
|
|
|
Payments received from litigation settlements(a)
|
|
|
(150.0)
|
|
|
-
|
|
Provision for inventory reserves(b)
|
|
|
18.1
|
|
|
5.2
|
|
Amortization and acquisition-related costs(c)
|
|
|
7.1
|
|
|
-
|
|
R&D partner milestone payment(d)
|
|
|
2.0
|
|
|
-
|
|
Hayward facility remediation costs(e)
|
|
|
1.9
|
|
|
1.0
|
|
Loss on asset disposal(f)
|
|
|
0.9
|
|
|
-
|
|
Gross profit earned on Zomig® Agreement
|
|
|
-
|
|
|
30.0
|
|
Income tax effect
|
|
|
39.9
|
|
|
(12.8)
|
|
Adjusted net income
|
|
$
|
25.3
|
|
$
|
35.8
|
|
|
|
|
|
|
|
Adjusted net income per diluted share
|
|
$
|
0.37
|
|
$
|
0.53
|
|
Net income per diluted share
|
|
$
|
1.55
|
|
$
|
0.18
|
|
|
|
|
|
|
|
|
|
|
|
Impax Laboratories, Inc.
|
|
Non-GAAP Financial Measures
|
|
|
|
|
|
The following table reconciles reported net income to adjusted
EBITDA.
|
|
|
|
|
|
|
|
(Unaudited, amounts in millions)
|
|
Three Months Ended
March 31,
|
|
|
|
2013
|
|
2012
|
|
Net income
|
|
$
|
105.4
|
|
$
|
12.4
|
|
Adjusted to add (deduct):
|
|
|
|
|
|
Interest income
|
|
|
(0.3)
|
|
|
(0.3)
|
|
Interest expense
|
|
|
0.3
|
|
|
0.0
|
|
Depreciation and other
|
|
|
5.3
|
|
|
3.7
|
|
Income taxes
|
|
|
48.3
|
|
|
6.3
|
|
EBITDA
|
|
|
159.0
|
|
|
22.1
|
|
|
|
|
|
|
|
Adjusted to add (deduct):
|
|
|
|
|
|
Payments received from litigation settlements(a)
|
|
|
(150.0)
|
|
|
-
|
|
Provision for inventory reserves(b)
|
|
|
18.1
|
|
|
5.2
|
|
Amortization and acquisition-related costs(c)
|
|
|
7.1
|
|
|
-
|
|
R&D partner milestone payment(d)
|
|
|
2.0
|
|
|
-
|
|
Hayward facility remediation costs(e)
|
|
|
1.9
|
|
|
1.0
|
|
Loss on asset disposal(f)
|
|
|
0.9
|
|
|
-
|
|
Gross profit earned on Zomig® Agreement
|
|
|
-
|
|
|
30.0
|
|
Share-based compensation
|
|
|
4.4
|
|
|
3.8
|
|
Adjusted EBITDA
|
|
$
|
43.4
|
|
$
|
62.1
|
|
|
|
|
|
|
|
|
|
(a)
|
|
As of March 31, 2013, the Company had a $102.0 million receivable in
connection with a previously announced settlement and license
agreement with Endo Pharmaceuticals, Inc., which was recorded as
other income in the first quarter 2013. The $102.0 million
receivable was received by the Company in April 2013. In addition,
in connection with the settlement of litigation relating to supply
of authorized generic Adderall XR® products to the Company under the
terms of the Shire Agreement, the Company received a one-time
payment of $48.0 million from Shire LLC in the first quarter 2013.
|
|
(b)
|
|
In the first quarter 2013, the Company recorded an inventory reserve
charge relating to discontinued products ($6.7 million), and a
reserve of pre-launch inventory for RYTARYTM ($5.0
million) and other generic products ($6.4 million) as a result of
the delay in the anticipated regulatory approvals.
|
|
(c)
|
|
Amortization and acquisition-related costs from the January 2012
AstraZeneca Agreement and the June 2012 Development, Distribution
and Supply Agreement with TOLMAR, Inc.
|
|
(d)
|
|
In the first quarter 2013, the Company recorded a $2.0 million
milestone payment under the terms of a research and development
partnership agreement.
|
|
(e)
|
|
Remediation costs relating to the Hayward, CA. manufacturing
facility.
|
|
(f)
|
|
In the first quarter 2013, the Company recorded a loss of $0.9
million on the disposal of an asset.
|
Source: Impax Laboratories, Inc.