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Quotes & Info
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| BRL > SEC Filings for BRL > Form 10-Q on 7-Aug-2008 | All Recent SEC Filings |
7-Aug-2008
Quarterly Report
Agreement with Allergan, Inc.
On May 5, 2008, we entered into an agreement with a subsidiary of Allergan,
Inc. related to Allergan's Sanctura® product that PLIVA divested in 2005 to
Esprit Pharma, which has since been acquired by Allergan. Under the terms of
this agreement, Allergan paid us $53.0 million, extinguishing any future payment
obligations related to Sanctura. This $53.0 million payment was recorded in
alliance and development revenue during the three months ended June 30, 2008 and
will not be repeated in future periods.
Business Activities
During the three months ended June 30, 2008, sales of our generic products
were $556.9 million, accounting for 83% of our total product sales. North
America accounted for $340.1 million, or 61%, of our generic product sales while
the rest of world ("ROW") accounted for $216.8 million, or 39%. Sales of our
proprietary products were $118.0 million, accounting for 17% of our total
product sales. In addition, we recorded $93.0 million of alliance and
development revenues during the quarter and $10.7 million of other revenues.
Alliance and development revenues are derived mainly from profit-sharing
arrangements, co-promotion agreements, and standby manufacturing fees and other
reimbursements and fees we received from third parties, including marketing
partners. Other revenues primarily are derived from our non-core operations,
which include our diagnostics, disinfectants, dialysis and infusions ("DDD&I")
business.
During the six months ended June 30, 2008, sales of our generic products were
$1,025.8 million, accounting for 83% of our total product sales. North America
accounted for $601.3 million of our generic product sales while the ROW
accounted for $424.5 million. Sales of our proprietary products were
$213.7 million, accounting for 17% of our total product sales. In addition, we
recorded $125.3 million of alliance and development revenues during the six
months and $21.8 million of other revenues.
During the six months ended June 30, 2008, we generated $169.0 million of
operating cash flows. Our operating cash flows are a significant source of
liquidity, and we expect to utilize a significant portion of these operating
cash flows to service our debt obligations as well as fund our capital needs
during 2008.
We recorded earnings of $0.73 per diluted share for our first half of 2008.
We expect our earnings per share in the second half of 2008 to be higher than in
the first half. Further, we expect that our fourth quarter earnings will be
significantly higher than our third quarter earnings due to several reasons
including (a) higher sales of Ocella (b) expected higher sales of Azithromycin
due to the seasonality of the product (c) the expected launch of a new generic
product in our fourth quarter, and (d) a lower tax rate in the fourth quarter as
compared to our third quarter, resulting from our expectation that the
U.S. research and development tax credit will be re-enacted in the fourth
quarter and applied retroactively to January 1, 2008.
Foreign currency exchange rate fluctuations
Our international revenues and expenses are subject to foreign currency
exchange rate fluctuations. These results are first converted from local
currencies into Croatian Kuna ("HRK"), and then converted from HRK into U.S.
dollars ("USD"). In general, the HRK exchange rate follows the exchange rate
fluctuations between the USD and the Euro. Depending on the direction of change
relative to the USD, foreign currency values can increase or decrease the
reported dollar value of our net assets and results of operations. While we
cannot predict with certainty changes in foreign exchange rates or the effect
they will have on us, we attempt to mitigate their impact through operational
means and by using various foreign exchange financial instruments. We use
foreign exchange financial instruments to hedge a portion of forecasted
transactions even though none of the instruments are eligible for hedge
accounting. Since our derivatives do not qualify for hedge accounting, the
changes in fair value of these instruments are being measured each period and
reported in other income (expense), which has led to volatility of our reported
net earnings in prior periods and may lead to further volatility in the future.
Despite the potential for increased earnings volatility, we still use such
instruments to offset the economic risk from foreign exchange rate fluctuations.
For purposes of discussing results on a comparable basis below, we will refer
to all total increases and decreases in US dollars, and often quantify the
amount of those changes that are due to changes in foreign currency exchange
rate fluctuations.
Generic Products
For many years, we have successfully utilized a strategy of developing the
generic versions of branded products that possess a combination of unique
factors that we believe have the effect of limiting competition for generics.
Such factors include difficult formulation, complex and costly manufacturing
requirements or limited raw material availability. By targeting products with
some combination of these unique factors, we believe that our generic products
will, in general, be less affected by the intense and rapid pricing pressure
often associated with more commodity-type generic products. As a result of this
focused strategy, we have been able to successfully identify, develop and market
generic products that generally have few competitors or that are able to enjoy
longer periods of limited competition, and thus generate profit margins higher
than those often associated with commodity-type generic products. The
development and launch of our generic oral contraceptive products is an example
of our generic development strategy.
Until our acquisition of PLIVA, the execution of this strategy was focused
predominantly on developing solid oral dosage forms of products. While we
believe there are more tablet and capsule products that may fit our
"barrier-to-entry" criteria, we have recently expanded our development
activities, both internally through our acquisition of PLIVA and through
collaboration with third parties, to develop non-tablet and non-capsule products
such as injectables, patches, creams, ointments, sterile ophthalmics and nasal
sprays.
We also develop and manufacture active pharmaceutical ingredients ("API"),
primarily for use internally and, to a lesser extent, for sale to third parties.
We manufacture 23 different APIs for use in pharmaceuticals through our
facilities located in Croatia and the Czech Republic. We believe that our
ability to produce API for internal use may provide us with a strategic
advantage over competitors that lack such ability, particularly as to the
timeliness of obtaining API for our products.
Challenging the patents covering certain brand products continues to be an
integral part of our generics business. For many products, the patent provides
the unique barrier that we seek to identify in our product selection process. We
try to be the first company to initiate a patent challenge because, in certain
cases, we may be able to obtain 180 days of exclusivity for selling the generic
version of the product. Upon receiving exclusivity for a product, we often
experience significant revenues and profitability associated with that product
for the 180-day exclusivity period, but, at the end of that period, we
experience significant decreases in our revenues and market share associated
with the product as other generic competitors enter the market. Our record of
successfully resolving patent challenges has made a recurring contribution to
our operating results, but has created periods of revenue and earnings
volatility and will likely continue to do so in the future. While earnings and
cash flow volatility may result from the launch of products subject to patent
challenges, we remain committed to this part of our business.
Proprietary Products
To help diversify our generic product revenue base, we initiated a program in
2001 to develop and market proprietary pharmaceutical products. We formalized
this program through our acquisition of Duramed Pharmaceuticals in October 2001,
and thereafter by establishing Duramed Research as our proprietary research and
development subsidiary. Today, Duramed is recognized as a leader in the area of
women's healthcare. We implement our women's healthcare platform through a
substantial number of employees dedicated to the development and marketing of
our proprietary products, including approximately 355 sales representatives that
promote directly to physicians six of our products - SEASONIQUE®, Enjuvia™,
Mircette®, ParaGard®, Plan B™ and Amniscreen - and two products under our
co-promotion agreement with Abbott Pharmaceuticals - Niaspan® and Advicor®. We
have accomplished significant growth in proprietary product sales over the last
several years through both internally-developed products, such as SEASONALE®,
which was the first and largest selling extended-cycle oral contraceptive in the
U.S., and SEASONIQUE, also an extended-cycle oral contraceptive, and through
product acquisitions, including ParaGard, the only non-drug loaded intrauterine
contraceptive ("IUC") currently on the market in the U.S., in November 2005;
Mircette, a well established 28-day oral contraceptive, in December 2005; Plan
B, an emergency oral contraceptive product in 2004; and Adderall IR, an
immediate-release, mixed salt amphetamine product that is indicated for the
treatment of attention deficit hyperactivity disorder and narcolepsy, in
October 2006.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2008 and June 30, 2007
The following table sets forth revenue data for the three and six months
ended June 30, 2008 and 2007 (dollars in millions):
Three Months Ended Six Months Ended
June 30, June 30,
Change Change
2008 2007 $ % 2008 2007 $ %
Product sales:
Generic products:
Oral contraceptives $ 155.4 $ 116.0 $ 39.4 34% $247.9 $ 229.2 $ 18.7 8%
Other generics 401.5 367.6 33.9 9% 777.9 726.4 51.5 7%
Total generic products 556.9 483.6 73.3 15% 1,025.8 955.6 70.2 7%
Proprietary products 118.0 102.3 15.7 15% 213.7 191.3 22.4 12%
Total product sales 674.9 585.9 89.0 15% 1,239.5 1,146.9 92.6 8%
Alliance and development revenue 93.0 36.4 56.6 155% 125.3 61.5 63.8 104%
Other revenue 10.7 11.5 (0.8 ) -7% 21.8 22.0 (0.2 ) -1%
Total revenues $ 778.6 $ 633.8 $ 144.8 23% $ 1,386.6 $ 1,230.4 $ 156.2 13%
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Product Sales
Generic Oral Contraceptives
During the three months ended June 30, 2008, sales of our generic oral
contraceptives ("Generic OCs") were $155.4 million, up $39.4 million, or 34% as
compared to the prior year period. The year-over-year increase is primarily due
to $45.0 million of sales from the June 2008 launch of Ocella, our generic
version of Bayer's Yasmin. This increase was partially offset by lower sales
across most of our other Generic OCs due to lower demand resulting from a change
in our customer mix, as well as lower sales on certain products including Apri
which was $3.6 million lower and Sprintec, which was $3.3 million lower compared
to the prior year.
During the six months ended June 30, 2008, sales of our Generic OCs were
$247.9 million, up $18.7 million, or 8% as compared to the prior year period.
The year over year increase is due to the launch of Ocella, as discussed above.
This increase more than offset declines in several other Generic OC products due
to lower demand due to the change in customer mix and lower pricing. These
factors resulted in lower sales of several products in our portfolio including
Aviane of $8.5 million, Apri of $6.8 million and Sprintec of $6.7 million, in
addition to an overall net decline on certain other products.
We continue to expect sales in calendar 2008 to exceed 2007 levels
principally due to contributions from Ocella. We expect sales of Ocella to more
than offset continued lower sales of across most of our other Generic OC
products due to lower market share and lower pricing as well as the expected
decline in sales of Kariva, the generic version of our proprietary Mircette
product, when the patent on Mircette expires in October 2008.
Other Generic Products
During the three months ended June 30, 2008, sales of our other generic
products ("Other Generics") were $401.5 million, up from $367.6 million in the
prior year period, an increase of $33.9 million, reflecting higher sales in the
U.S. and higher sales in our European and ROW markets. The increase in our
European and ROW markets is primarily attributable to a $31.5 million favorable
impact from changes in foreign currency exchange rates. In addition to exchange
rate fluctuations, higher sales in our Central and Eastern Europe markets,
including Russia, more than offset lower sales in Croatia and Poland.
During the current period, we also recorded $6.2 million of higher U.S. sales
of Vitamin D related to higher demand and also recorded $5.6 million in sales of
Alendronate in the U.S., which we launched in February 2008, and sales of
$6.9 million from our September 2007 acquisition of ORCA in Germany. Partially
offsetting these increases were lower U.S. sales of Ondansetron of $6.1 million
and net decreases across several of our Other Generics due to declines in price
and/or volume.
During the six months ended June 30, 2008, sales of Other Generics were
$777.9 million, up from $726.4 million in the prior year period, an increase of
$51.5 million. Changes in foreign currency exchange rates accounted for
$59.4 million of the increase. Higher sales of Fentanyl of $10.7 million due to
higher volume, and contributions of $23.6 million from the launch of Alendronate
in 2008 and from our acquisition of ORCA. These increases were partially offset
by lower U.S. sales of Ondansetron of $16.0 million due to lower volume and
lower prices due to new competition, and lower sales across several of our Other
Generics due to declines in price and/or volume.
We expect sales of our Other Generics for 2008 to increase significantly
compared to 2007 in large part due to the current weakness in the U.S. Dollar
compared to its value in 2007.
Proprietary Products
During the three months ended June 30, 2008, sales of our proprietary
products were $118.0 million, an increase of $15.7 million, or 15%, as compared
to the prior year period. This increase was partially due to a $6.4 million
increase in sales of Diamox benefiting from higher pricing and a year-over-year
increase in unit sales due to supply issues in the prior year. In addition, we
recorded a $5.5 million increase in sales of SEASONIQUE and a $3.9 million
increase in sales of ParaGard, both due to an increase in demand sales and
pricing. These increases combined with other increases of our proprietary
products more than offset a $5.5 million decrease in sales of SEASONALE.
During the six months ended June 30, 2008, sales of our proprietary products
were $213.7 million, an increase of $22.4 million, or 12%, as compared to the
prior year period. This increase was primarily due to a $17.1 million increase
in sales of SEASONIQUE due to higher demand, an $8.9 million increase in sales
of Diamox, a $7.3 million increase in sales of ParaGard and a $5.9 million
increase in sales of Plan B OTC/Rx, all due to higher prices and volume. These
increases more than offset a $12.3 million decrease in sales of SEASONALE due to
the impact from generic competition and a $4.6 million decrease in sales of
Adderall IR due to lower volume.
We anticipate sales growth in our proprietary segment during the second half
of 2008 reflecting an expected acceleration in demand for Plan B and SEASONIQUE
along with continued higher demand for ParaGard in the third quarter.
Alliance and Development Revenue
During the three months ended June 30, 2008, we recorded $93.0 million of
alliance and development revenue, up from $36.4 million in the prior year
period. This $56.6 million increase was principally due to a $53.0 million
payment from Allergan, as discussed above. In addition, revenues earned under
our license and development agreement with Shire increased by $10.4 million as
compared to the same period in the prior year, reflecting reimbursements of
research and development costs we incurred. Offsetting these increases was a
decrease of $6.9 million in revenues from our profit-sharing arrangement with
Teva on generic Allegra caused by declining sales of Allegra.
During the six months ended June 30, 2008, we recorded $125.3 million of
alliance and development revenue, up from $61.5 million in the prior year
period. This increase of $63.8 million, was principally due to the $53.0 million
one-time payment from Allergan discussed above. In addition, revenues earned
under our license and development agreement with Shire increased by
$12.4 million reflecting higher reimbursements of research and development costs
we incurred.
Other Revenue
We recorded $10.7 million and $11.5 million of other revenue during the three
months ended June 30, 2008 and 2007, respectively, and $21.8 million and
$22.0 million of other revenue during the six months ended June 30, 2008 and
2007, respectively. This revenue is primarily attributable to non-core
operations, which includes our diagnostics, disinfectants, dialysis and
infusions business.
Cost of Sales
The following table sets forth cost of sales data, in dollars, as well as the
resulting gross margins expressed as a percentage of product sales (except
''other'', which is expressed as a percentage of our other revenue line item),
for the three and six months ended June 30, 2008 and 2007 (dollars in millions):
Three Months Ended June 30, Six Months Ended June 30,
Change Change
2008 2007 $ % 2008 2007 $ %
Generic products $ 307.3 $ 246.7 $ 60.6 25 % $ 543.7 $ 509.8 $ 33.9 7 %
Gross margin 44.8 % 49.0 % 47.0 % 46.7 %
Proprietary products $ 36.2 $ 22.9 $ 13.3 58 % $ 66.7 $ 52.8 $ 13.9 26 %
Gross margin 69.3 % 77.6 % 68.8 % 72.4 %
Other revenue $ 9.4 $ 5.4 $ 4.0 74 % $ 17.9 $ 11.7 $ 6.2 53 %
Gross margin 12.1 % 53.0 % 17.9 % 46.8 %
Total cost of sales $ 352.9 $ 275.0 $ 77.9 28 % $ 628.3 $ 574.3 $ 54.0 9 %
Gross margin 48.5 % 54.0 % 50.2 % 50.9 %
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Cost of sales components include the following:
• our manufacturing and packaging costs for products we manufacture;
• amortization expense;
• the write-off of the step-up in inventory arising from acquisitions, including PLIVA;
• profit-sharing or royalty payments we make to third parties, including raw material suppliers;
• the cost of products we purchase from third parties;
• net realizable value adjustments to our inventories; and
• stock-based compensation expense relating to employees within certain departments that we allocate to cost of sales.
Generics: Generic segment cost of sales for the three months ended June 30,
2008 were $60.6 million higher than in the prior period due to increases in unit
sales and foreign currency rates. During the three months ended June 30, 2008,
our generics gross margins decreased from 49.0% to 44.8% reflecting increased
sales of lower margin products including Ocella, one of our highest selling
generic products, which currently carries a margin well below the margins we
earn on our other Generic OC products. Our margins were also lower compared to
the prior year period due to lower absorption of fixed costs as production
levels were lower than in the prior year period. In addition, our gross margins
were negatively impacted by the weakness of the U.S. Dollar compared to its
value in the prior year.
Generic segment cost of sales for the six months ended June 30, 2008 were
$33.9 million higher than the prior period due to increases in unit sales and
foreign currency rates (net of an inventory step-up charge of $32.2 million
recorded in the prior period for the sale of inventory obtained in the PLIVA
acquisition). During the six months ended June 30, 2008, our generics gross
margins increased slightly to 47.0% from 46.7% compared to the prior year
period. Our gross margins during the current period were negatively impacted by
the expected lower margin earned from Ocella, as discussed above, and higher
production related costs including higher inventory provisions and lower
absorption of fixed costs, discussed above. In addition, gross margins were
negatively impacted by the weakness of the U.S. Dollar compared to its value in
the prior year.
Proprietary: Proprietary segment cost of sales for the three months ended
June 30, 2008 were $13.3 million higher than in the prior period due to
increases in unit sales. During the three months ended June 30, 2008, our
proprietary gross margins decreased from 77.6% to 69.3% compared to the prior
year period, resulting from higher amortization costs in total and as a
percentage of proprietary product sales during the three months ended June 30,
2008, and a slightly unfavorable mix of lower margin products during the current
quarter.
Proprietary segment cost of sales for the six months ended June 30, 2008 were
$13.9 million higher than in the prior period due to increases in unit sales.
During the six months ended June 30, 2008, our proprietary products margins
decreased from 72.4% to 68.8% compared to the prior year period, resulting from
higher product amortization expense as noted above and a similar unfavorable mix
of lower margin products during the six month period.
During the period ended June 30, 2008, all remaining profit-sharing and
royalty obligations due to third parties for Cenestin, Diamox, Ziac, and Zebeta
were achieved based on the applicable profit milestones. As a result, the gross
margins from these products in future periods will be higher than margins earned
historically.
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