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| WPI > SEC Filings for WPI > Form 10-Q on 2-May-2008 | All Recent SEC Filings |
2-May-2008
Quarterly Report
In March 2006, Takeda filed an NDA for this combination product and the NDA
is under review by the U.S. Food and Drug Administration ("FDA"). If approved
and launched, we are eligible to receive future milestone payments and royalties
from Takeda's sale of this product.
Our valuation of this IPR&D project at the Andrx Acquisition date was
$133 million.
Enoxaparin Sodium (generic version of Lovenox®)
On May 2, 2005, Andrx entered into an agreement to obtain certain exclusive
marketing rights for Amphastar Pharmaceuticals, Inc.'s ("Amphastar's") generic
version of Sanofi-Aventis' ("Aventis'") Lovenox® injectable product. Amphastar
submitted its Abbreviated New Drug Application ("ANDA") for generic Lovenox® to
the FDA in March 2003. Amphastar's ANDA is the subject of a patent infringement
lawsuit filed by Aventis. On February 8, 2007, the District Court ruled that
Aventis' patent was unenforceable due to inequitable conduct. Final judgment in
favor of Amphastar was entered on March 9, 2007. Aventis has appealed and the
matter remains pending in the United States Court of Appeals for the Federal
Circuit. Amphastar has not obtained FDA approval for its product and the product
continues to be delayed by a Citizen Petition, including two supplements, and
other factors. Amphastar has submitted comments to Aventis' Citizen Petition and
supplements. Additionally, in November 2007, the FDA requested Amphastar to
provide additional data regarding the potential immunogenicity of the product.
Amphastar has responded to the FDA's request for additional information. Our
marketing rights for this product generally extend to the U.S. retail pharmacy
market, and we will receive up to 50% of the net profits, as defined, generated
from such sales. The launch of this product is dependent upon Amphastar
obtaining FDA approval.
Our valuation of this IPR&D project at the Andrx Acquisition date was
$33 million.
Metoprolol Succinate (generic version of Toprol-XL®)
In 2003 and 2004, Andrx filed ANDAs seeking FDA approval to market metoprolol
succinate extended-release tablets in the 25mg, 50mg, 100mg and 200mg strengths.
Andrx was awarded 180-days of market exclusivity for the 50mg strength. During
the second quarter of this year, we announced that pursuant to an agreement with
Sandoz Pharmaceutical Corporation, a subsidiary of Novartis AG ("Sandoz"), we
relinquished our rights to a 180-day period of marketing exclusivity for our
50mg strength product. As a result of our agreement to relinquish our marketing
exclusivity, Sandoz obtained final approval of its ANDA for metoprolol succinate
extended-release 50 mg tablets. We are entitled to a share of Sandoz's profits
on sales of the product, which began in the third quarter of 2007.
We continue to pursue approval of our own pending ANDAs for metoprolol
succinate extended-release tablets.
Our valuation of this IPR&D project at the Andrx Acquisition date was
$85 million.
Methylphenidate Hydrochloride (generic version of Concerta®)
Andrx has pending ANDAs for the generic versions of Concerta®
(methylphenidate hydrochloride extended-release tablets) in the 18mg, 27mg, 36mg
and 54mg strengths.
In September 2005, ALZA Corporation and McNeil-PPC, Inc. sued Andrx for
patent infringement related to the generic version of Concerta®. In
December 2007, the United States District Court for the District of Delaware
completed the trial of this matter. No decision has been issued to date. The
ANDAs remain under review by the FDA and a Citizen Petition has been filed by
McNeil-PPC, Inc. relating to approval criteria for generic versions of
Concerta®. Final approval may be subject to obtaining a waiver or expiration of
a third party's 180 days of market exclusivity.
Our valuation of this IPR&D project at the Andrx Acquisition date was
$94 million.
Omeprazole (generic version of Prilosec®)
Andrx has pending ANDAs for omeprazole delayed-release capsules, 10mg, 20mg
and 40 mg strengths, which are bioequivalent to Prilosec®. In 2001, AstraZeneca
filed suit against Andrx alleging infringement of a patent (patent no.
6,013,281) ("the '281 patent") directed to a process for making an omeprazole
formulation. Andrx filed counterclaims of non-infringement, invalidity and
unenforceability. In May 2004, the district court ruled that the '281 patent was
invalid due to obviousness. In April 2007, the U.S. Court of Appeals for the
Federal Circuit affirmed the 2004 District Court decision that the '281 patent
is invalid.
The ANDAs remain under review by the FDA. Upon approval and launch, we
believe that we are entitled to the 180-day period of market exclusivity with
respect to the generic version of the 40mg strength of Prilosec®.
Our valuation of this IPR&D project at the acquisition date was $57 million.
Diltiazem HCl ER (Cardizem® LA)
Andrx Corporation has pending ANDAs with the FDA for generic versions of
Cardizem® LA (diltiazem HCl extended-release tablets), 120mg, 180mg, 240mg,
300mg, 360mg and 420mg strengths. Andrx initially filed its ANDA for the 420mg
strength on April 25, 2005, with a Paragraph IV certification and notification
to the patent holder. On August 10, 2005, Biovail Laboratories Int'l SRL
("Biovail"), which is the holder of the NDA for Cardizem® LA, initiated a patent
infringement lawsuit against Andrx for the 420mg strength in the U.S. District
Court for the District of Delaware. Andrx subsequently amended its initial ANDA
submission to include the 120mg, 180mg, 240mg, 300mg and 360mg strengths, along
with a related Paragraph IV certification and notice letter. On October 14,
2005, Biovail initiated a patent infringement lawsuit on the remaining
strengths. On December 4, 2007, we announced that we settled the litigation with
Biovail. Under the terms of the settlement, Biovail has granted us an exclusive
license to its U.S. patents covering Cardizem® LA for a generic version of
Cardizem® LA. The agreement generally provides that we that will not commence
marketing our generic equivalent product until April 1, 2009.
The ANDAs remain under review by the FDA.
Our valuation of this IPR&D project at the Andrx Acquisition date was
$12 million.
Results of Operations
Prescription pharmaceutical products in the U.S. are generally marketed as
either generic or brand pharmaceuticals. Generic pharmaceutical products are
bioequivalents of their respective brand products and provide a cost-efficient
alternative to brand products. Brand pharmaceutical products are marketed under
brand names through programs that are designed to generate physician and
consumer loyalty.
Watson has three reportable operating segments: Generic, Brand and
Distribution. The Generic segment includes off-patent pharmaceutical products
that are therapeutically equivalent to proprietary products. The Brand segment
includes the Company's lines of Specialty Products and Nephrology products.
Watson has aggregated its Brand product lines in a single segment because of
similarities in regulatory environment, methods of distribution and types of
customer. This segment includes patent-protected products and certain
trademarked off-patent products that Watson sells and markets as Brand
pharmaceutical products. The Company sells its Brand and Generics products
primarily to pharmaceutical wholesalers, drug distributors and chain drug
stores. The Distribution segment mainly distributes generic pharmaceutical
products manufactured by third parties, as well as by Watson, primarily to
independent pharmacies, pharmacy chains, pharmacy buying groups and physicians'
offices under the Anda trade name. Sales are principally generated through an
in-house telemarketing staff and through internally developed ordering systems.
The Distribution segment operating results exclude sales of Watson generic and
brand products, which are included in their respective segment results.
The Company evaluates segment performance based on segment net revenues,
gross profit and contribution. Segment contribution represents segment gross
profit less direct R&D expenses and selling and marketing expenses. The Company
has not allocated corporate general and administrative expenses or amortization
as such information has not been used by management, or has not been accounted
for at the segment level.
Three Months Ended March 31, 2008 Compared to Three Months Ended March 31, 2007
Three Months Ended March 31, 2008 Three Months Ended March 31, 2007
Generic Brand Distribution Total Generic Brand Distribution Total
Product sales $ 342,459 $ 98,992 $ 144,902 $ 586,353 $ 411,475 $ 90,638 $ 145,440 $ 647,553
Other 24,297 16,299 - 40,596 13,150 10,902 - 24,052
Net revenues 366,756 115,291 144,902 626,949 424,625 101,540 145,440 671,605
Cost of sales(1) 229,723 27,526 122,853 380,102 272,623 25,215 126,882 424,720
Gross profit(1) 137,033 87,765 22,049 246,847 152,002 76,325 18,558 246,885
Gross margin(1) 37.4 % 76.1 % 15.2 % 39.4 % 35.8 % 75.2 % 12.8 % 36.8 %
Research and
development 22,597 15,418 - 38,015 26,513 11,295 - 37,808
Selling and
marketing 14,053 27,995 14,032 56,080 14,549 26,411 14,203 55,163
Contribution $ 100,383 $ 44,352 $ 8,017 152,752 $ 110,940 $ 38,619 $ 4,355 153,914
Contibution margin 27.4 % 38.5 % 5.5 % 24.4 % 26.1 % 38.0 % 3.0 % 22.9 %
General and
administrative 50,553 48,055
Amortization 20,179 43,933
Operating income $ 82,020 $ 61,926
Operating margin 13.1 % 9.2 %
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(1) Excludes amortization of acquired intangibles including product rights.
Generic Segment
Net Revenues
Our Generic segment develops, manufactures, markets, sells and distributes
generic products that are the therapeutic equivalent to their brand name
counterparts and are generally sold at prices significantly less than the brand
product. As such, generic products provide an effective and cost-efficient
alternative to brand products. When patents or other regulatory exclusivity no
longer protect a brand product, opportunities exist to introduce off-patent or
generic counterparts to the brand product. Additionally, we distribute generic
versions of third parties' brand products (sometimes known as "Authorized
Generics") to the extent such arrangements are complementary to our core
business. Our portfolio of generic products includes products we have internally
developed, products we have licensed from third parties, and products we
distribute for third parties.
Net revenues in our Generic segment includes product sales and other revenue.
Our Generic segment product line includes a variety of products and dosage
forms. Indications for this line include pregnancy prevention, pain management,
depression, hypertension and smoking cessation. Dosage forms include oral
solids, transdermals, injectables and transmucosals.
Other revenues consist primarily of royalties and commission revenue.
Net revenues from our Generic segment for the three months ended March 31,
2008 decreased 13.6% or $57.9 million to $366.8 million compared to net revenues
of $424.6 million from the prior year period. This decrease in sales was mainly
attributable to higher net sales of Authorized Generics ($72.4 million) in the
prior year period including oxycodone HCl controlled release tablets and
pravastatin sodium tablets offset in part by sales of alendronate sodium tablets
launched in the current quarter. The decrease in sales was offset in part by an
increase in other revenue ($11.1 million). Increases in net revenues from new
product launches were offset by price erosion within our base business.
The increase in other revenues in the three months ended March 31, 2008 for
the Generic segment was primarily related to royalties on sales by Sandoz, Inc.
of metoprolol succinate 50 mg extended release tablets (which commenced during
the third quarter of 2007).
Gross Profit (Gross Margin)
Gross profit represents net revenues less cost of sales. Cost of sales
includes production and packaging costs for the products we manufacture, third
party acquisition costs for products manufactured by others, profit-sharing or
royalty payments for products sold pursuant to licensing agreements, inventory
reserve charges and excess capacity utilization charges, where applicable. Cost
of sales does not include amortization costs for acquired product rights or
other acquired intangibles.
Gross profit for our Generic segment decreased $15.0 million to
$137.0 million in the three months ended March 31, 2008 compared to
$152.0 million in the prior year period. The decrease in gross profit was
primarily due to reduced gross profit contribution from lower sales of
Authorized Generics in the current period ($20.2 million) and facility
rationalization costs ($12.9 million) offset by an increase in other revenue
($11.1 million). Increases in gross profit from new product launches were offset
by price erosion within our base business.
Gross margins for our Generic segment increased 1.6 percentage points to
37.4% for the three months ended March 31, 2008 from 35.8% in the prior year
period. This increase in gross margin was primarily related to the increase in
other revenue in the current quarter.
Research and Development Expenses
Generic segment R&D expenses consist predominantly of personnel-related
costs, contract research, biostudy and facilities costs associated with the
development of our products.
Generic segment R&D expenses decreased 14.8% or $3.9 million to $22.6 million
in the three months ended March 31, 2008 compared to $26.5 million in the prior
year period due to reduced spending on biostudy costs in the current period.
Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities
costs, insurance and professional services costs.
Generic segment selling and marketing expenses decreased 3.4% or $0.5 million
to $14.1 million in the three months ended March 31, 2008 compared to
$14.5 million in the prior year period.
Brand Segment
Net Revenues
Our brand pharmaceutical business develops, manufactures, markets, sells and
distributes products within two sales and marketing groups: Specialty Products
and Nephrology.
Our Specialty Products product line includes urology products such as
Trelstar® and Oxytrol® and a number of non-promoted products.
Our Nephrology product line consists of products for the treatment of iron
deficiency anemia and is generally marketed to nephrologists and dialysis
centers. The major products of the Nephrology group are Ferrlecit® and INFeD®,
which are used to treat low iron levels in patients undergoing hemodialysis in
conjunction with erythropoietin therapy.
Other revenues in the Brand segment consist primarily of co-promotion
revenue, royalties and the recognition of deferred revenue relating to our
obligation to manufacture and supply brand products to third parties. Other
revenues also include revenue recognized from R&D and licensing agreements.
Net revenues from our Brand segment for the three months ended March 31, 2008
increased 13.5% or $13.8 million to $115.3 million compared to net revenues of
$101.5 million in the prior year period. The increase was primarily attributable
to higher sales within the Nephrology group ($5.5 million), higher other
revenues ($5.4 million) and higher sales within the Specialty Products group
($2.8 million). The increase within the Nephrology group was primarily
attributable to customer buying patterns and lower sales in the prior year
period due to the loss of a customer. The increase within the Specialty Products
group was primarily attributable to higher unit sales of Trelstar® as a result
of promotional efforts.
Gross Profit (Gross Margin)
Gross profit for our Brand segment increased $11.4 million to $87.8 million
in the three months ended March 31, 2008 compared to $76.3 million in the prior
year period. The increase in gross profit was primarily due to an increase in
other revenues ($5.4 million) and higher product sales.
Gross margins for our Brand segment increased to 76.1% during the three
months ended March 31, 2008 from 75.2% in the prior year period primarily due to
the increase in other revenues.
Research and Development Expenses
Brand segment R&D expenses consist predominantly of personnel-related costs,
contract research, clinical costs and facilities costs associated with the
development of our products.
Brand segment R&D expenses increased 36.5% or $4.1 million to $15.4 million
in the three months ended March 31, 2008 compared to $11.3 million in the prior
year period primarily due to a $5.0 million milestone payment related to the
filing of an NDA for silodosin with the FDA.
Selling and Marketing Expenses
Brand segment selling and marketing expenses consist mainly of
personnel-related costs, product promotion costs, distribution costs,
professional services costs, insurance and depreciation.
Brand segment selling and marketing expenses increased 6.0% or $1.6 million
to $28.0 million in the three months ended March 31, 2008 as compared to
$26.4 million in the prior year period.
Distribution Segment
Net Revenues
Our Distribution segment mainly distributes generic pharmaceutical products
manufactured by third parties, as well as by Watson, primarily to independent
pharmacies, pharmacy chains, pharmacy buying groups and physicians' offices.
Sales are principally generated through an in-house telemarketing staff and
through internally developed ordering systems. The Distribution segment
operating results exclude Watson generic and brand products, which are included
in their respective segment results.
Net revenues from our Distribution segment for the three months ended
March 31, 2008 decreased 0.4% or $0.5 million to $144.9 million compared to net
revenues of $145.4 million in the prior year period.
Gross Profit (Gross Margin)
Gross profit for our Distribution segment increased $3.5 million to
$22.0 million in the three months ended March 31, 2008 compared to $18.6 million
in the prior year period. Gross margins also improved for our Distribution
segment increasing to 15.2% during the three months ended March 31, 2008 from
12.8% in the prior year period. Distribution segment gross profit and gross
margin improved in the current quarter as the prior year period was negatively
impacted by a $2.5 million acquisition-related inventory charge.
Selling and Marketing Expenses
Selling and marketing expenses consist mainly of personnel costs, facilities
costs, insurance and freight costs, which support the Distribution segment sales
and marketing functions.
Segment Contribution
Three Months Ended March 31, Change
($ in thousands): 2008 2007 Dollars %
Segment contribution
Generic $ 100,383 $ 110,940 $ (10,557 ) (9.5 )%
Brand 44,352 38,619 5,733 14.8 %
Distribution 8,017 4,355 3,662 84.1 %
$ 152,752 $ 153,914 $ (1,162 ) (0.8 )%
as % of net revenues 24.4 % 22.9 %
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For more information on segment contribution, refer to above Management's Discussion and Analysis of Financial Condition and Results of Operations and "NOTE 3 - OPERATING SEGMENTS" in the accompanying "Notes to Condensed Consolidated Financial Statements" in this Quarterly Report.
Corporate General and Administrative Expenses
Three Months Ended March 31, Change
($ in thousands): 2008 2007 Dollars %
Corporate general and administrative expenses $ 50,553 $ 48,055 $ 2,498 5.2 %
as a % of net revenues 8.1 % 7.2 %
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Corporate general and administrative expenses consist mainly of personnel
costs, facilities costs, insurance and professional services costs, which are
general in nature and not directly related to specific segment operations.
Corporate general and administrative expenses increased during the three
months ended March 31, 2008 as compared to the same period of the prior year
primarily due to costs incurred in the implementation of a new enterprise
resource planning system at certain sites.
Amortization
Three Months Ended March 31, Change
($ in thousands): 2008 2007 Dollars %
Amortization $ 20,179 $ 43,933 $ (23,754 ) (54.1 )%
as a % of net revenues 3.2 % 6.5 %
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The Company's amortizable assets consist primarily of acquired product rights. For the three months ended March 31, 2008 amortization expense decreased 54.1% or $23.8 million as our Ferrlecit® product rights were fully amortized as . . .
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