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| HAE > SEC Filings for HAE > Form 10-K on 22-May-2012 | All Recent SEC Filings |
22-May-2012
Annual Report
• Payment of monthly rental fees; and
• An asset utilization performance metric, such as performing a minimum level of procedures per month per device.
Our disposables revenue stream, which includes the sales of disposables and fees
for the use of our equipment, accounted for approximately 81.7% , 81.5% and
86.0% of our total revenue for fiscal 2012, 2011 and 2010, respectively.
In April 2012, we announced two acquisitions that will provide us with a
commercial presence in all aspects of the whole blood collection market, a
market in which historically we have not meaningfully participated. We entered
into a definitive agreement to acquire the business assets of the blood
collection, filtration and processing product lines of Pall Corporation for $551
million. The blood processing systems and equipment to be acquired are for use
in transfusion medicine and include Pall's manufacturing facilities in Covina,
California; Tijuana, Mexico; Ascoli, Italy and a portion of Pall's assets in
Fajardo, Puerto Rico. Approximately 1,300 employees will be transferred to
Haemonetics. We also entered into a definitive agreement to acquire the business
assets of Hemerus Medical, LLC, a Minnesota-based company that develops
innovative technologies for the collection of whole blood, and processing and
storage of blood components. Under the terms of the agreement, we will pay up to
$27 million contingent upon on certain regulatory approvals. We expect both
acquisitions to close in the second quarter of fiscal 2013.
Market Trends
Plasma Market
Changes in demand for plasma-derived pharmaceuticals, particularly
immunoglobulin ("IG"), is the key driver of plasma collection volumes in the
commercial plasma collection market. Various factors related to the supply of
plasma and the production of plasma-derived pharmaceuticals also affect demand,
including the following:
• Industry consolidation continues among plasma collectors and
fractionators. Industry consolidation impacts us when a collector changes
the total number of its collection centers, the total number of
collections performed per center or changes the plasma collection system
(either Haemonetics or a competitive technology) used to perform some or
all of those collections.
• The supply of source plasma also affects demand for additional collections of source plasma.
• The newer plasma fractionation facilities are more efficient in their production processes, utilizing less plasma to make similar quantities of pharmaceuticals and vaccines.
• Reimbursement guidelines affect the demand for end product pharmaceuticals, although a high off-label use of
pharmaceuticals occurs.
• Newly approved indications and diagnosis of new patients requiring plasma
derived therapies increase the demand for plasma, along with longer
lifespans and a growing aging patient population requiring therapy, and
bio-pharmaceutical geographical expansion.
Demand for plasma in fiscal 2012 was particularly strong in North America where
approximately two-thirds of commercial plasma is collected. While global markets
for plasmapheresis have been relatively flat, the market in Japan has declined.
The Japanese Red Cross has shifted some of its plasma for fractionation from
plasmapheresis to recovered plasma from whole blood collections. This change has
reduced demand for automated plasma collections. Currently, demand for
plasma-derived therapies is driving mid-single digit growth of plasma
collection.
Blood Center Market
In the blood center market, we sell products used in the collection of platelets
and red cells.
Despite modest increases in the demand for platelets in Europe and Japan,
improved collection efficiencies that increase the yield of platelets per
collection and more efficient use of collected platelets have resulted in a flat
market for automated collections and related disposables in these countries.
With changes in healthcare and social security systems in emerging markets, a
larger number of people get access to state of the art medical treatments, which
drives the demand for platelet transfusions and represent a faster growing
market.
After several years of modest increases in demand for red cell transfusions and
a general shortage of volunteer donors, the market in recent years has
experienced lower demand for red cells due to slow growth in elective procedures
coupled with increased focus on better blood management practices. The reduced
demand for red cells adversely impacted our red cell business. As the
baby-boomer population ages, we expect a return to modest increases in demand
for red cells. Furthermore, as blood collectors are forced to improve operating
efficiency, reduce costs and maintain regulatory compliance, there will be
modest growth opportunities for our red cell technology in the future.
Hospital Market
In the hospital market, we sell cardiovascular surgical blood salvage systems,
orthopedic surgical blood salvage systems, and a blood diagnostics instrument.
Our Cell Saver brand surgical blood salvage system was designed as a solution
for rapid, high volume blood loss procedures, such as cardiovascular surgeries.
This part of the surgical blood salvage market is declining and will likely
continue to decline due to improved surgical techniques which minimize blood
loss and less invasive procedures. The cardioPAT system, a surgical blood
salvage system targeted at cardiovascular procedures when there is less blood
loss, is designed to meet the market needs created by these improved surgical
techniques. The cardioPAT can be used intra-operatively as well as
post-operatively when blood loss continues while the patient is in recovery.
Our OrthoPAT technology is used to salvage red cells in high blood loss
orthopedic procedures, including hip and knee replacement surgeries. The
OrthoPAT is the only system on the market designed to collect, separate and wash
a patient's shed blood both during and after surgery. While cell salvage is not
yet a standard of care for U.S. orthopedic procedures, we position this device
as an effective alternative to stored red cells (both autologous predonated and
allogeneic) and non-washed autotransfusion systems. Particularly in the United
States, hip and knee replacement surgeries are frequently elective surgeries and
as a result are subject to change in economic conditions.
Our TEG Thromobelastograph Hemostasis Analyzer is a diagnostic tool which
provides a comprehensive assessment of a patient's overall hemostasis. The
benefit is that this information enables caregivers to decide the best
blood-related clinical treatment for the individual patient in order to minimize
blood loss and reduce incidence of "reoperations". The test is expanding beyond
cardiac surgery into trauma, as well as helping manage surgical timing of
patients on anti-platelet medications such as clopidogrel. TEG product line
sales further strengthened in fiscal 2012. This product's growth is dependent on
hospitals adopting this technology as a standard practice in their blood
management programs.
Software Market
Our software solutions portfolio addresses many of the critical data collection
and data management needs within the plasma, blood center, and hospital markets
and is also a key component of our blood management solutions today. In fiscal
2012, the pressures to improve efficiencies, reduce cost, and improve patient
outcomes continued to be key drivers in all three market segments.
Demand for our plasma software solution remained steady in fiscal 2012 although
we anticipate a sub-segment of this market will continue to migrate towards
homegrown proprietary software solutions in an effort to gain unique competitive
advantages.
In fiscal 2012, within the blood center market, we saw a modest increase in demand for our El Dorado Software Solution Suite even with the continued pricing pressures and trend towards consolidation amongst blood centers in the United States. Interest and demand for our newest product El Dorado Donor continues to grow globally as customers look to upgrade their systems of record to a modern, more flexible, comprehensive platform. Interest and demand remains steady for our Hemasphere, eDonor, and Donor Doc software solutions as centers look for ways to continue to optimize efficiencies within the planning, scheduling, donor recruitment, and data collection process steps associated with a blood drive. The demand for our flagship blood banking solution, SafeTrace TX, continues to grow steadily within the hospital market. In fiscal 2012 we continued to see demand for reliable, proven safety systems within blood banks even though many hospitals IT organizations were largely focused on meaningful use initiatives. Further growth in this area will be partly dependent on the continued ability for hospitals to leverage our existing full service capabilities to help them effectively and efficiently complete implementations. Interest and demand also continues to grow globally for our remote allocation and point of care transfusion systems, as care providers look for ways to improve efficiencies and meet compliance guidelines for tracking and dispositioning of blood components to patients.
Financial Summary (In thousands, except per March 31, April 2, April 3, % Increase/(Decrease) 12 % Increase/(Decrease) 11 share data) 2012 2011 2010 vs. 11 vs. 10 Net revenues $ 727,844 $ 676,694 $ 645,430 7.6 % 4.8 % Gross profit $ 369,240 $ 355,209 $ 337,481 4.0 % 5.3 % % of net revenues 50.7 % 52.5 % 52.3 % Operating expenses $ 280,482 $ 244,661 $ 254,200 14.6 % (3.8 )% Operating income $ 88,758 $ 110,548 $ 83,281 (19.7 )% 32.7 % % of net revenues 12.2 % 16.3 % 12.9 % Other income (expense), net $ 740 $ (467 ) $ (2,010 ) (258.5 )% (76.8 )% Income before taxes $ 89,498 $ 110,081 $ 81,271 (18.7 )% 35.4 % Provision for income tax $ 22,612 $ 30,101 $ 22,901 (24.9 )% 31.4 % % of pre-tax income 25.3 % 27.3 % 28.2 % Net income $ 66,886 $ 79,980 $ 58,370 (16.4 )% 37.0 % % of net revenues 9.2 % 11.8 % 9.0 % Earnings per share-diluted $ 2.59 $ 3.12 $ 2.24 (17.0 )% 39.3 % |
Our fiscal year ends on the Saturday closest to the last day of March. Fiscal
2012 and 2011 each includes 52 weeks with each quarter having 13 weeks. Fiscal
2010 includes 53 weeks with each of the first three quarters having 13 weeks and
the fourth quarter having 14 weeks. For fiscal 2011, net revenue increased 4.8%.
Excluding the effect of the extra week in fiscal 2010, net revenue for fiscal
2011 increased 6.7%.
Net revenue for fiscal 2012 increased 7.6% over fiscal 2011. Without the effects
of foreign exchange, net revenue increased 5.6% over fiscal 2011. The increase
reflects strong revenue growth from our plasma, blood center, diagnostics
businesses and increased equipment and software sales, offset by declines due to
a recall of certain of our OrthoPAT devices. Fiscal 2012 revenue growth also
benefited from purchases by the Japanese Red Cross in March 2012 to avoid future
supply disruptions in anticipation of an internal business system conversion.
Net revenue for fiscal 2011 increased 4.8% over fiscal 2010. Without the effects
of foreign exchange, net revenue increased 4.6% over fiscal 2010. The increase
noted reflects the positive impact of acquisitions, which contributed 5.3% to
revenue growth for fiscal year 2011, as well as strong revenue growth from
emerging markets, notably Russia and Asia.
Our gross profit amount increased 4.0% during fiscal 2012. Without the effects
of foreign exchange, gross profit increased 1.5% over fiscal 2011. Our gross
profit margin percentage decreased by 180 basis points for fiscal 2012 as
compared to fiscal 2011. The decrease was primarily due to increased product
quality costs and lower overall margin associated with lower sales of
higher-margin hospital products and higher sales of lower-margin plasma
disposables.
Our gross profit amount increased 5.3% during fiscal 2011. Without the effects
of foreign exchange, gross profit increased 5.4%, which was largely driven by
higher software sales as a result of the Global Med acquisition and cost
improvements in our manufacturing operations. Our gross profit margin percentage
improved 20 basis points for fiscal 2011 as compared to fiscal 2010. Increased
software sales positively impacted gross margin percentage. These increases were
partly offset by increased inventory reserves during fiscal 2011.
Operating expenses increased 14.6% during fiscal 2012 over fiscal 2011. Without
the effects of foreign exchange, operating expenses increased 11.2% during
fiscal 2012. Higher operating expenses include $3.1 million of expenses, net of
insurance recovery, associated with European customer claims arising from a
quality matter with our High Separation Core Bowl ("HS Core"), $3.0 million of
transaction costs related to the definitive purchase agreements announced in
April 2012 with Pall Corporation and Hemerus Medical, LLC, increased
restructuring costs, increased investment in research and development and sales
and marketing and higher bonus expense.
Operating expenses decreased 3.8% during fiscal 2011 over fiscal 2010. Without
the effects of foreign exchange, operating expenses decreased 3.7% during fiscal
2011. Fiscal 2010 included asset write downs totaling $15.7 million related to
the abandonment of our next generation platelet apheresis platform and a blood
center donation management software product. No similar write downs were
experienced in fiscal 2011. The decreases for fiscal 2011 also included a
reduction in the expense associated with cash bonus incentive compensation. The
decreases were offset by higher operating expenses associated with the
Global Med acquisition.
During fiscal 2012, operating income decreased 19.7% compared to fiscal 2011.
Without the effects of foreign currency, operating income decreased 20.4%
compared to fiscal 2011 as increases in operating expenses more than offset
gross profit associated with revenue growth due to higher costs of quality,
relatively higher sales of our lower-margin products, expenses associated with
European customer claims arising from a quality matter with HS Core, and
transaction costs.
During fiscal 2011, operating income increased 32.7% compared to fiscal 2010.
Without the effects of foreign currency, operating income increased 32.6% over
fiscal 2010. The growth in revenue from our emerging markets, the acquisition of
Global Med and lower cash bonus incentive compensation were significant
contributors to the improvement in operating income. Additionally, we incurred
significant costs in fiscal 2010 related to asset write downs, positively
impacting operating income growth as no similar costs were incurred in fiscal
2011.
Net income decreased 16.4% during fiscal 2012. Without the effects of foreign
exchange, net income decreased 18.1% for fiscal 2011. The decrease in net income
was attributable to the decline in operating income described above.
Net income increased 37.0% during fiscal 2011. Without the effects of foreign
exchange, net income increased 36.3% for fiscal 2011. The increases in operating
income and lower foreign exchange losses were the principal reasons for the
improvement in net income.
RESULTS OF OPERATIONS
Net Revenues by Geography
March 31, April 2, April 3, % Increase/(Decrease) 12 % Increase/(Decrease) 11
(In thousands) 2012 2011 2010 vs. 11 vs. 10
United States $ 352,160 $ 317,355 $ 303,965 11.0 % 4.4 %
International 375,684 359,339 341,465 4.5 % 5.2 %
Net revenues $ 727,844 $ 676,694 $ 645,430 7.6 % 4.8 %
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International Operations and the Impact of Foreign Exchange
Our principal operations are in the U.S., Europe, Japan and other parts of Asia.
Our products are marketed in more than 97 countries around the world through a
combination of our direct sales force and independent distributors and agents.
Our revenue generated outside the U.S. approximated 51.6%, 53.1%, and 52.9% of
net revenue during fiscal 2012, 2011, and 2010, respectively. During fiscal
2012, 2011, and 2010, revenue in Japan accounted for approximately 17.1%, 16.3%,
and 17.0%, respectively, of our total revenue. Revenue from Europe accounted for
approximately 25.2%, 27.6%, and 28.0% of our total revenue for fiscal 2012,
2011, and 2010, respectively. International sales are generally conducted in
local currencies, primarily the Japanese Yen and the Euro. Our results of
operations are impacted by changes in the value of the Yen and the Euro relative
to the U.S. Dollar.
For fiscal 2012 as compared to fiscal 2011, the effects of foreign exchange
resulted in a 2.0% increase in sales. For fiscal 2011 as compared to fiscal
2010, the effects of foreign exchange accounted for a 0.2% increase in sales.
Please see section entitled "Foreign Exchange" in this discussion for a more
complete explanation of how foreign currency affects our business and our
strategy for managing this exposure.
Net Revenues by Product Type
March 31, April 2, April 3, % Increase/(Decrease) 12 % Increase/(Decrease) 11
(In thousands) 2012 2011 2010 vs. 11 vs. 10
Disposables $ 594,933 $ 551,836 $ 555,226 7.8 % (0.6 )%
Software solutions 70,557 66,876 35,919 5.5 % 86.2 %
Equipment & other 62,354 57,982 54,285 7.5 % 6.8 %
Net revenues $ 727,844 $ 676,694 $ 645,430 7.6 % 4.8 %
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Disposables Revenues by Product Type
March 31, April 2, April 3, % Increase/(Decrease) 12 % Increase/(Decrease) 11
(In thousands) 2012 2011 2010 vs. 11 vs. 10
Plasma disposables $ 258,061 $ 227,209 $ 232,378 13.6 % (2.2 )%
Blood center disposables
Platelet 167,946 156,251 151,026 7.5 % 3.5 %
Red cell 48,034 46,828 48,031 2.6 % (2.5 )%
215,980 203,079 199,057 6.4 % 2.0 %
Hospital disposables
Surgical 66,619 66,503 69,942 0.2 % (4.9 )%
OrthoPAT 31,186 35,631 37,079 (12.5 )% (3.9 )%
Diagnostics 23,087 19,414 16,770 18.9 % 15.8 %
120,892 121,548 123,791 (0.5 )% (1.8 )%
Total disposables revenue $ 594,933 $ 551,836 $ 555,226 7.8 % (0.6 )%
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Disposables Revenue
Disposables include the Plasma, Blood Center, and Hospital product lines.
Disposables revenue increased 7.8% during fiscal 2012 and decreased 0.6% during
fiscal 2011. Without the effect of foreign exchange, disposables revenue
increased 5.7% and decreased 0.7% for fiscal 2012 and 2011, respectively.
Plasma
Plasma disposables revenue increased 13.6% during fiscal 2012. Without the
effects of foreign exchange, plasma disposables revenue increased 12.7% during
fiscal 2012, primarily due to increased plasma collections by our commercial
fractionation customers in North America. We expect collection growth rates to
moderate in fiscal 2013. Also, recent contract renewals for the majority of the
current commercial plasma business included price decreases which we expect will
adversely affect the revenue growth rate for fiscal 2013.
Plasma disposables revenue decreased 2.2% during fiscal 2011. Without the
effects of foreign exchange, plasma disposables revenue decreased 1.3% during
fiscal 2011. This decrease was driven by lower apheresis plasma collection
volume in Japan as more plasma was sourced by the Japanese Red Cross as a
byproduct from its whole blood collections. Additionally, one of our significant
customers removed one of its products from the market, which negatively affected
our sales in the U.S. and Europe. Finally, our commercial plasma customers
slowed their growth and in some cases reduced collections in the first half of
fiscal 2011 following several years of significant growth.
Blood Center
Blood Center consists of disposables used to collect platelets, red cells, and
plasma for transfusion.
Platelet
Platelet disposables revenue increased 7.5% during fiscal 2012. Without the
effect of foreign exchange, platelet disposable revenue increased 2.5% during
fiscal 2012. The increase included the benefit of quality issues experienced
with a competitor's device in Japan, increased sales in emerging markets, and
purchases by the Japanese Red Cross in March 2012 to avoid future supply
disruptions in anticipation of an internal business system conversion. We expect
the platelet disposable revenue growth rate for the first quarter of fiscal 2013
to be negatively impacted by these Japanese Red Cross purchases.
Platelet disposables revenue increased 3.5% during fiscal 2011. Without the
effect of foreign exchange, platelet disposable revenue increased 1.5% during
fiscal 2011. Sales increased across emerging markets throughout the fiscal year,
which is the primary driver of the increase in revenue. Sales declines in our
European direct market were attributable to competition and the switch from
apheresis platelets to platelets derived from whole blood collections, which is
the primary driver for the decline in net revenue in Europe.
Red Cell
Red cell disposables revenue increased 2.6% during fiscal 2012. Without the
effects of foreign exchange, red cell disposables revenue increased 2.6% during
fiscal 2012, driven primarily by increased account penetration at existing
customers for red cells in North America.
Red cell disposables revenue decreased 2.5% during fiscal 2011. Without the
effects of foreign exchange, red cell disposables revenue decreased 2.0% during
fiscal 2011. The decrease was driven by lower demand for red cells as a result
of fewer surgeries, resulting in a reduced demand for automated red cell
collection.
Hospital
Hospital consists of Surgical, OrthoPAT, and Diagnostics products. The hospital
product line includes the following brand platforms: the Cell Saver brand, the
TEG brand, the OrthoPAT brand and the cardioPAT brand.
Surgical
Surgical disposables revenue consists principally of the Cell Saver and
cardioPAT products. Revenue from our surgical disposables increased 0.2% during
fiscal 2012. Without the effect of foreign exchange, surgical disposables
revenue decreased 2.2% during fiscal 2012, due to competitive pressures and a
decrease in demand across our European and North American markets associated
with lower surgical volumes. During fiscal 2012, we introduced the Cell Saver
Elite, our next generation surgical device, first in North America and then
across all geographies. Based on results observed for the fourth quarter of
fiscal 2012, this new device is gaining traction in the marketplace and should
positively impact fiscal 2013 surgical disposables
revenue results.
Revenue from our surgical disposables decreased 4.9% during fiscal 2011. Without
the effect of foreign exchange, surgical disposables revenue decreased 4.8% for
the fiscal year due to a decrease in demand across our European and North
American markets, driven by both competitive pressures and market conditions
resulting in fewer surgeries. This decrease was partly offset by strong sales in
our emerging markets.
OrthoPAT
Revenue from our OrthoPAT disposables decreased 12.5% during fiscal 2012.
Without the effect of foreign exchange, OrthoPAT disposables revenue decreased
by 13.4%. The voluntary recall of our OrthoPAT devices manufactured prior to
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