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| ENDP > SEC Filings for ENDP > Form 10-Q on 5-Nov-2012 | All Recent SEC Filings |
5-Nov-2012
Quarterly Report
The following Management's Discussion and Analysis of Financial Condition and
Results of Operations describes the principal factors affecting the results of
operations, liquidity and capital resources, and critical accounting estimates
of Endo. This discussion should be read in conjunction with the accompanying
quarterly unaudited Condensed Consolidated Financial Statements and our Annual
Report on Form 10-K, for the year ended December 31, 2011 (Annual Report). Our
Annual Report includes additional information about our significant accounting
policies, practices and the transactions that underlie our financial results, as
well as a detailed discussion of the most significant risks and uncertainties
associated with our financial and operating results. Except for the historical
information contained in this Report, this Report, including the following
discussion, contains forward-looking statements that involve risks and
uncertainties. See "Forward-Looking Statements" beginning on page i of this
Report.
EXECUTIVE SUMMARY
About the Company
At our Annual Meeting of Stockholders on May 23, 2012, our stockholders approved
the proposal to amend and restate our Amended and Restated Certificate of
Incorporation to change our name from Endo Pharmaceuticals Holdings Inc. to Endo
Health Solutions Inc, which we refer to herein as "Endo", "we", "us", or the
"Company". This change became effective on May 23, 2012. Concurrently with this
change, the Company also changed the names of its business segments. Effective
May 23, 2012, the names of our business segments are Endo Pharmaceuticals
(formerly Branded Pharmaceuticals), Qualitest (formerly Generics), AMS (formerly
Devices) and HealthTronics (formerly Services).
Endo Health Solutions Inc. is a U.S. based, specialty healthcare solutions
company with a diversified business model, operating in four key business
segments-Endo Pharmaceuticals, Qualitest, AMS and HealthTronics. Our Endo
Pharmaceuticals and Qualitest segments offer a variety of branded and generic
pharmaceutical products in multiple therapeutic areas. AMS provides technology
solutions to physicians treating men's and women's pelvic health conditions.
Finally, HealthTronics provides urological services, products and support
systems to urologists, hospitals, surgery centers and clinics. As a combined
entity, we deliver comprehensive healthcare solutions across our diversified
businesses in key therapeutic areas, including pain and urology, and believe we
are positioned to address the changing economics that are driving the continued
transformation of the U.S. healthcare environment.
We believe our diversified business model enables us to strengthen our
partnerships with providers, payers and patients by offering multiple products
and platforms to deliver healthcare solutions. We have a portfolio of branded
pharmaceuticals that includes established brand names such as Lidoderm®, Opana®
ER, Voltaren® Gel, Percocet®, Frova®, Supprelin® LA, Vantas®, Valstar® and
Fortesta® Gel. Endo Pharmaceuticals comprised approximately 56% and 55% of our
revenues for the three and nine months ended September 30, 2012, respectively,
compared to 56% and 62%, respectively, in the comparable 2011 periods. Lidoderm®
comprised approximately 32% and 30% of our revenues for the three and nine
months ended September 30, 2012, respectively, compared to 27% and 31%,
respectively, for the three and nine months ended September 30, 2011. Our
non-branded Qualitest portfolio, which accounted for 22% and 21%, respectively,
of our revenues for the three and nine months ended September 30, 2012 and 19%
and 22%, respectively, of our revenues for the three and nine months ended
September 30, 2011, currently consists of products primarily focused on pain
management. We generally focus on selective generics that have one or more
barriers to market entry, such as complex formulation, regulatory or legal
challenges or difficulty in raw material sourcing. AMS accounted for 15% and 17%
of our revenues for the three and nine months ended September 30, 2012,
respectively, compared to 17% and 8%, respectively, for the three and nine
months ended September 30, 2011. HealthTronics accounted for the remaining
revenue for the three and nine months ended September 30, 2012 and 2011.
As of September 30, 2012, we have a dedicated pharmaceutical products sales
force consisting of 481 sales representatives and 228 contracted sales
representatives (subsequently reduced to 170 effective October 5, 2012 pursuant
to a September 2012 amendment to our agreement with our partner, Ventiv
Commercial Services, LLC) focusing primarily on pain products, 78 Endo sales
representatives focusing primarily on bladder and prostate cancer products, 35
Endo medical center representatives focusing on the treatment of central
precocious puberty and 17 Endo account executives focusing on managed markets
customers. We also have 324 sales representatives focusing primarily on devices
and 54 on services. We market our products and services to primary care
physicians and specialty physicians, including those specializing in pain
management, orthopedics, neurology, rheumatology, surgery, anesthesiology,
urology and pediatric endocrinology. Our sales force also targets retail
pharmacies and other healthcare professionals throughout the United States.
Watson Litigation Settlement
On May 28, 2012, Endo Pharmaceuticals Inc. (EPI) entered into a Settlement and
License Agreement (the Watson Settlement Agreement) among EPI and Teikoku, on
the one hand, and Watson, on the other hand. The Watson Settlement Agreement
settled all ongoing patent litigation among the parties relating to Watson's
generic version of Lidoderm®.
On August 23, 2012, Watson announced it received FDA approval on its Abbreviated
New Drug Application (ANDA) for its lidocaine patch 5%, a generic version of
Lidoderm®. The Company anticipates Watson will launch its generic version of
Lidoderm® on September 15, 2013 pursuant to the terms of the Watson Settlement
Agreement.
For further details, see Note 12. Commitments and Contingencies of the Condensed
Consolidated Financial Statements included in Part I, Item 1 of this Quarterly
Report on Form 10-Q.
Litigation-Related Contingencies
During the third quarter of 2012, we recorded an accrual in the amount of $82.6
million for certain of our legal proceedings, with respect to certain pricing
litigation matters and the ongoing investigation by the United States Department
of Health and Human Services, Office of Inspector General and the United States
Department of Justice relating primarily to the sale, marketing and promotion of
Lidoderm®. These matters are described in more detail in Note 12. Commitments
and Contingencies of the Condensed Consolidated Financial Statements included in
resistant formulation and in September 2012, we announced that, according to IMS
Health data estimates, the crush-resistant formulation of Opana® ER now accounts
for more than 90 percent of the Opana® ER total prescription volume.
On August 13 2012, EPI submitted a Citizen Petition with the FDA requesting that
it (1) determine that the discontinued, non-crush-resistant version of Opana® ER
approved under NDA No. 021610 was discontinued for safety and can no longer
serve as a Reference List Drug (RLD) for an ANDA or generic applicant; (2)
refuse to approve any pending ANDA for a generic version of the non-crush
resistant version of Opana® ER approved under NDA No. 021610; and (3) suspend
and withdraw the approval of any ANDA referencing Opana® ER approved under NDA
No. 021610 as the RLD.
On August 31, 2012, EPI submitted an additional Citizen Petition requesting that
the FDA (1) require that any ANDA referencing the crush-resistant formulation of
Opana® ER contain data and information demonstrating that the proposed ANDA
product is similarly crush-resistant; (2) classify extended-release opioid
formulations incorporating crush-resistant technologies, such as the new Opana®
ER, as new dosage forms in Appendix C of FDA's Orange Book; and (3) confirm that
any ANDA referencing Opana® ER approved under NDA No. 021610 will not be
identified in the Orange Book as therapeutically equivalent to the
crush-resistant formulation of Opana® ER.
From September 21, 2012 through November 1, 2012, EPI and its partner Grünenthal
received Paragraph IV Notices from each of Teva Pharmaceuticals USA, Inc.
(Teva), Amneal Pharmaceuticals, LLC (Amneal), Sandoz Inc. (Sandoz) and ThoRx
Laboratories, Inc. (ThoRx) advising of the filing by each such company of an
ANDA for a generic version of the formulation of Opana® ER designed to be
crush-resistant.
MoXy® Fiber
In August 2012, the Company introduced the new 650kJ MoXy® fiber for our
GreenLight XPS® system for photoselective vaporization of the prostate, which
provides more than 50 percent more energy than the previous fiber for the same
price. The new MoXy® fiber will enable physicians to treat larger glands with a
single fiber, offering improved overall value and greater cost efficiency.
Montelukast Sodium Tablets
In August 2012, the Company announced it had launched its montelukast sodium
tablets and chewable tablets, generic versions of Singulair®, following the
expiration of the last patent that provides Merck U.S. market exclusivity. The
Company began shipping the product immediately. Montelukast sodium tablets are
labeled for use in treating symptoms of asthma and allergic rhinitis. The total
combined branded and generic sales for montelukast sodium tablets and chewable
tablets in the U.S. for the twelve months ending June 30, 2012 were
approximately $4.9 billion, according to IMS Health.
Levetiracetam
In April 2012, Qualitest Pharmaceuticals announced it had received FDA approval
on its ANDA for levetiracetam oral solution 100 mg/mL, a generic version of
Keppra®. to begin distribution in late 2012. The total sales for levetiracetam
oral solution 100 mg/mL in the U.S. for the twelve months ending December 31,
2011 were approximately $62.2 million, according to IMS Health. Subsequently, in
July 2012, Qualitest Pharmaceuticals announced it had received FDA approval on
its ANDA for levetiracetam extended-release 500 and 750 mg tablets, a generic
version of Keppra XR®. The total sales for levetiracetam extended-release 500
and 750 mg tablets in the U.S. for the 12 months ending May 31, 2012 were
approximately $124.8 million, according to IMS Health.
Other
In October, our Qualitest business received, through its partner Alembic
Pharmaceuticals Limited, FDA approval for irbesartan tablets, a generic version
of Avapro®, irbesartan/HCTZ tablets, a generic version of Avalide® and modafinil
tablets, a generic version of Provigil®. Total combined branded and generic
sales for irbesartan tablets, irbesartan/HCTZ tablets and modafinil tablets in
the U.S. for the 12 months ended September 30, 2012 were approximately $1.7
billion, according to IMS Health.
Goodwill and Indefinite-Lived Intangible Assets Impairment Testing
During the three months ended September 30, 2012, we changed our annual goodwill
and indefinite-lived intangible assets impairment test date from January 1 to
October 1. The change in the annual date for impairment testing will necessitate
completing a test as of October 1, 2012 to ensure that no more than 12 months
elapse between annual tests. We will complete this test in the fourth quarter
ending December 31, 2012. We will prospectively apply the changes in the annual
goodwill and indefinite-lived intangible asset impairment testing dates
beginning on October 1, 2012 in future filings.
Changes in Directors & Officers and Other Related Matters
On July 18, 2012, Endo announced the appointment of Camille Farhat as President
of American Medical Systems, a wholly owned subsidiary of Endo Health Solutions
Inc. Prior to joining AMS, Mr. Farhat served in a variety of senior leadership
positions within the healthcare industry; most recently as General Manager
of Baxter Pharmaceuticals and Technologies. As General Manager, Mr. Farhat
significantly enhanced the performance and improved the operating efficiency of
the business while focusing on the needs
of patients. During his time at Baxter, he also held the role of General Manager
for Baxter Global Infusion Systems. Before that, Mr. Farhat provided executive
leadership at Medtronic, including roles in Business Development, as well as
Global General Manager, Gastroenterology and Urology. In addition, he held a
variety of positions at GE Healthcare, including roles as a Global General
Manager of the Computed Tomography Business. He also held leadership positions
in strategic planning and global sourcing at General Electric.
On September 27, 2012, the Company increased the size of its Board of Directors
from nine to ten and appointed Jill D. Smith to fill this new vacancy. Ms. Smith
currently serves on the board of SoundBite Communications and is a member of the
executive committee for the Women's Cancer Program at Dana Farber Hospital, and
a member of the board of trustees for The Rashi School. Previously, Ms. Smith
served as the chairman of the board of directors and chief executive officer of
DigitalGlobe, Inc., and prior to DigitalGlobe, Ms. Smith was president and chief
executive officer of eDial, chief executive officer of SRDS, L.P., as well as
chief operating officer of Micron Electronics, Inc. Ms. Smith also has served on
the corporate boards of Elster Group and Smith & Hawken. Ms. Smith's earlier
professional experience includes co-founding Treacy & Company, LLC, a consulting
and boutique investment business and holding executive positions at Sara Lee
Corporation and Bain & Company.
Government Regulations
EPI and Qualitest sell products that are "controlled substances" as defined in
the Controlled Substances Act of 1970 (CSA), which establishes certain security
and record keeping requirements administered by the DEA. The DEA is concerned
with the control of registered handlers of controlled substances, and with the
equipment and raw materials used in their manufacture and packaging, in order to
prevent loss and diversion into illicit channels of commerce. The DEA regulates
controlled substances as Schedule I, II, III, IV or V substances, with Schedule
I and II substances considered to present the highest risk of substance abuse
and Schedule V substances the lowest risk. Hydrocodone is currently regulated as
a Schedule III substance. Pursuant to the Food and Drug Administration
Innovation Safety Act FDASIA), Congress has required the FDA to convene a
meeting to solicit advice and recommendations to assist in conducting a
scientific and medical evaluation on whether to reschedule combination products
containing hydrocodone. Our Qualitest business sells a significant amount of
hydrocodone-containing products. Congress is acting in response to continued
reports of misuse, abuse and addiction of products containing hydrocodone. An
advisory committee to take public comments on the proposed rescheduling was
originally planned for October 29-30, 2012. It was postponed due to weather
conditions and we expect will be rescheduled in the near future. A change from a
Schedule III substance to a Schedule II substance could restrict patient access
to needed medication. It would also require significant changes to the entire
industry's supply chain from manufacturers, to wholesalers and retailers. We
believe the increased burden and cost to the healthcare system would be
substantial. On October 25, 2012, the FDA published a briefing document that
indicates that it will likely recommend to DEA that hydrocodone products remain
in Schedule III. It did, however, acknowledge that the question still remains on
how to reduce levels of abuse of hydrocodone combination products. As part of
our expansion of our Huntsville site, we have factored in the potential for
hydrocodone being rescheduled, which we believe puts our subsidiary, Qualitest
Pharmaceuticals, in a very good position to comply quickly should hydrocodone be
rescheduled.
Healthcare Reform
On March 23, 2010, President Obama signed into law H.R. 3590, the Patient
Protection and Affordable Care Act (PPACA), which will make major changes to the
U.S. healthcare system. On March 30, 2010, the President signed H.R. 4872, the
Health Care and Education Reconciliation Act of 2010 (Reconciliation Act), which
included a package of changes to the PPACA, as well as additional elements to
reform health care in the U.S.
While some provisions of the new healthcare reform law have already taken
effect, most of the provisions to expand access to health care coverage will not
be implemented until 2014 and beyond. Since implementation is incremental to the
enactment date of the law, there are still many challenges and uncertainties
ahead. Such a comprehensive reform measure will require expanded implementation
efforts on the part of federal and state agencies embarking on rule-making to
develop the specific components of their new authority. The Company will monitor
closely the implementation and any attempts to repeal, replace, or remove
funding of the new health care reform law. This effort will primarily take place
on two fronts: 1) in Congress through attempts to pass legislation to overturn
all or specific sections of the law and 2) in the Courts through attempts to
have the law declared unconstitutional.
In March 2012, the U.S. Supreme Court heard oral arguments challenging the
constitutionality of the health care reform law. In the following months, the
Court considered the constitutionality of the individual mandate, as well as
whether the overall health care law could still stand even if the individual
mandate was ruled unconstitutional. On June 28, 2012, the Supreme Court upheld
the individual mandate. By virtue of ruling that the individual mandate is
constitutional, the entire law remains constitutional. In its ruling, the Court
did address the expansion of Medicaid required under the law, a provision that
requires states to expand Medicaid to approximately 17 million additional
low-income individuals up to 133 percent of the federal poverty level. Under the
law, the federal government would pay the additional costs for the expansion of
Medicaid for the years 2014 to 2016 and then the federal share would phase down
to 90 percent by 2020. The law provided that if a state did not expand its
Medicaid program eligibility to 133 percent, they would risk losing the federal
share for all its Medicaid funding and not just the funding for the expansion.
On this matter, the
Supreme Court upheld the constitutionality of the Medicaid expansion but ruled
that the punitive aspects of the provision are unconstitutional meaning that the
federal government does not have the authority to terminate existing federal
funding for Medicaid if the states do not expand Medicaid. This aspect of the
ruling may cause some states to refuse to expand its Medicaid eligibility
thereby limiting the number of individuals with access to health insurance.
The passage of the PPACA and the Reconciliation Act will result in a
transformation of the delivery and payment for health care services in the U.S.
The combination of these measures will expand health insurance coverage to an
estimated 32 million Americans. In addition, there are significant health
insurance reforms that are expected to improve patients' ability to obtain and
maintain health insurance. Such measures include: the elimination of lifetime
caps; no rescission of policies; and no denial of coverage due to preexisting
conditions. The expansion of healthcare insurance and these additional market
reforms should result in greater access to the Company's products.
Our estimate of the overall impact of healthcare reform reflects a number of
uncertainties. However, we believe that the impact to our business will be
largely attributable to changes in the Medicare Part D Coverage Gap, the
imposition of an annual fee on branded prescription pharmaceutical
manufacturers, and increased rebates in the Medicaid Fee-For-Service Program and
Medicaid Managed Care plans. There are a number of other provisions in the
legislation that collectively are expected to have a small impact, including
originator average manufacturers' price (AMP) for new formulations, and the
expansion of 340B pricing to new entities. Certain elements of healthcare reform
reduced total revenues by approximately $40 million in 2011 and will continue to
have a similar impact in future years.
In the U.S., the Medicare Prescription Drug Improvement and Modernization Act of
2003 continues to provide an effective prescription drug benefit to seniors and
individuals with disabilities in the Medicare program (Medicare Part D).
Uncertainty will continue to exist due to Congressional proposals that have the
potential to impose new costs and increase pricing pressures on the
pharmaceutical industry.
In response to the U.S. debt-ceiling crisis, Congress passed the Budget Control
Act of 2011 on August 2, 2011. Within the Act, Congress created the Joint Select
Committee on Deficit Reduction (JSC), which was charged with issuing a formal
recommendation on how to reduce the federal deficit by $1.2 trillion to $1.5
trillion over the next ten years. The Budget Control Act provided that if
Congress failed to pass a deficit reduction plan by December 23, 2011, a process
of sequestration would occur on January 1, 2013 which will result in
across-the-board spending cuts to certain government programs, including
Medicare, in order to meet the deficit reduction goal. Since the JSC failed to
put forth a proposal and Congress ultimately failed to pass a deficit reduction
plan, the sequestration process is scheduled to be triggered in 2013. The
automatic spending cuts that would occur as a result of the sequestration
process are unpalatable for many lawmakers and Congress may use the 2012 session
to consider repealing the cuts by finding savings in other programs, such as
Medicaid.
RESULTS OF OPERATIONS
Our quarterly results have fluctuated in the past, and may continue to
fluctuate. These fluctuations are primarily due to (1) the timing of mergers,
acquisitions and other business development activity, (2) the timing of new
product launches, (3) purchasing patterns of our customers, (4) market
acceptance of our products, (5) the impact of competitive products and products
we recently acquired and (6) pricing. These fluctuations are also attributable
to charges incurred for compensation related to stock compensation, amortization
of intangible assets, asset impairment charges, and certain upfront, milestone
and other payments made or accrued pursuant to acquisition or licensing
agreements.
Consolidated Results Review
Revenues. Revenues for the three months ended September 30, 2012 decreased 1% to
$750.5 million. This decrease was primarily driven by reduced revenues from our
AMS and Endo Pharmaceuticals segments. This fluctuation was partially offset by
revenue growth from our Qualitest segment. For the nine months ended
September 30, 2012, total revenues increased 16% to $2,226.3 million from the
comparable 2011 period. This increase in revenues was primarily driven by
revenue growth from our Endo Pharmaceuticals, Qualitest and HealthTronics
segments as well as the timing of our acquisition of AMS during the second
quarter of 2011, from which we derived a full period's revenue during the nine
months ended September 30, 2012 compared to less than four months during the
comparable 2011 period.
The following table displays our revenues by category and as a percentage of
total revenues for the three and nine months ended September 30, 2012 and 2011
(dollars in thousands). We have retrospectively revised the segment presentation
for all periods presented reflecting a change from three to four reportable
segments:
Three Months Ended September 30, Nine Months Ended September 30,
. . .
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