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| QCOR > SEC Filings for QCOR > Form 10-Q on 9-Nov-2009 | All Recent SEC Filings |
9-Nov-2009
Quarterly Report
clinically superior to Acthar or is considered by the FDA to have an active
ingredient that is different from the active ingredient of Acthar.
In the first quarter of 2009, we completed the initial phase of our MS sales
force expansion plan, hiring and training our sales force as well as completing
all territorial realignments. A second phase of our sales force expansion was
completed in the third quarter of 2009. Our expanded sales force of 38
representatives allows us to build upon continued positive growth trends in
prescriptions of Acthar for the treatment of exacerbations associated with MS,
an indication for which Acthar is already approved.
We are also in discussions with experts in other disease states with high
unmet medical needs for which there is a potential therapeutic role for Acthar.
As a result of these initiatives, we are currently funding 25 pre-clinical and
clinical studies. Many of these studies are examining the use of Acthar in the
treatment of nephrotic syndrome, a disorder involving deterioration of kidney
function that often leads to the need for renal dialysis or transplant. We are
also now beginning to fund exploratory pre-clinical research evaluating whether
Acthar could have potential value in the management of amyotrophic lateral
sclerosis (also known as ALS or Lou Gehrig's Disease) and traumatic brain
injury.
From January 1, 2009 through November 9, 2009, we have repurchased a total of
2.4 million shares of our common stock for $11.2 million under our stock
repurchase plan, at an average price of $4.70 per share. In May 2009, our board
of directors increased our common share repurchase program authorization by an
additional 6.5 million shares. As of November 9, 2009, there are a total of
7.6 million shares authorized remaining under the revised stock repurchase plan.
Since the initiation of this program in early 2008, we have returned
approximately $57 million to shareholders through our common and preferred stock
buyback efforts.
Our results of operations may vary significantly from quarter to quarter
depending on, among other factors, demand for our products by patients,
inventory levels of our products held by third parties, the amount of Medicaid
rebates on our products dispensed to Medicaid eligible patients, the amount of
chargebacks on the sale of our products by our specialty distributor to
government-supported entities, the availability of finished goods from our
sole-source manufacturers, the timing of certain expenses, the introduction of a
competitive product, and our ability to develop growth opportunities for Acthar.
Critical Accounting Policies
Our management's discussion and analysis of our financial condition and
results of operations is based upon our consolidated financial statements, which
have been prepared in accordance with U.S. generally accepted accounting
principles. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities,
revenues and expenses, and related disclosures. On an on-going basis, we
evaluate our estimates, including those related to our Medicaid rebate
obligation related to our products dispensed to Medicaid eligible patients,
other government rebate programs and chargebacks on sales of our products by
wholesalers and our specialty distributor to government-supported entities,
inventories, intangible assets, share-based compensation, lease termination
liability and income taxes. We base our estimates on historical experience and
on various other assumptions that we believe are reasonable under the
circumstances, the results of which form the basis for making judgments about
the carrying values of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different
assumptions or conditions. We believe the following critical accounting policies
affect our more significant judgments and estimates used in the preparation of
our consolidated financial statements.
Sales Reserves
For the three and nine month periods ended September 30, 2009 and 2008, we
have estimated reserves for Medicaid rebates to all states for products
dispensed to patients covered by Medicaid; government chargebacks for sales of
our products by wholesalers and our specialty distributor to certain Federal
government organizations including such organizations as the Veterans
Administration; and reserves for rebates related to a health coverage program
called Tricare. For the three and nine month periods ended September 30, 2008,
we estimated reserves for product returns from our specialty distributor,
wholesalers, hospitals and pharmacies. Gross sales are also reduced for payments
made under our Acthar patient co-payment assistance programs. We estimate our
reserves by utilizing historical information for our existing products and data
obtained from external sources.
Significant judgment is inherent in the selection of assumptions and the
interpretation of historical experience as well as the identification of
external and internal factors affecting the estimates of our reserves for
Medicaid rebates and other government program rebates and chargebacks. We
believe that the assumptions used to estimate these sales reserves are
reasonable considering known facts and circumstances. However, our actual
Medicaid rebates and other government program rebates and chargebacks could
differ significantly from our estimates because of unanticipated changes in
prescription trends or patterns in the states' submissions of
Medicaid claims, adjustments to the amount of product in the distribution
channel, and new interpretations of the Medicaid statutes and regulations. If
actual Medicaid rebates, or other government program rebates and chargebacks are
significantly different from our estimates, such differences would be accounted
for in the period in which they become known. Historically, actual amounts have
been generally consistent with our estimates. However, during the three month
period ended September 30, 2009, we received higher than anticipated amounts of
Medicaid rebates related to prior period Acthar usage. In connection with the
receipt of these rebates, we increased our rebate reserve which reduced net
sales in the third quarter of 2009 by approximately $4.6 million. During the
three month period ended September 30, 2009, we recorded an additional rebate
reserve which reduced net sales by $1.4 million as a result of a final rule
issued by the Department of Defense for potential rebates due for drugs sold by
retail pharmacies to Tricare beneficiaries. Of the $1.4 million recorded during
the three month period ended September 30, 2009, $0.4 million related to sales
that were recorded in the quarter ended June 30, 2009.
Medicaid Rebates
We provide a rebate related to product dispensed to Medicaid eligible
patients in instances where regulations provide for such a rebate. Our a)
estimated rebate percentage, adjusted for b) recent and expected future
utilization rates for these programs, is used to estimate the rebate units
associated with product shipped during a period as follows:
a) The estimated liability included in sales-related reserves as of the end
of a period is comprised of the estimated rebate units associated with end
user demand data during the period, the estimated rebate units associated
with estimated inventory in the distribution channel as of the end of the
period, and the estimated rebate units associated with prior rebate
periods.
b) In order to assess current and future rates of Medicaid utilization, we analyze inventory levels received from a third party, CuraScript SD, patient prescription and shipment data received from a third party, CuraScript SP, and claims-level detail received from state Medicaid agencies.
The rebate amount per unit is determined based on a formula established by
statute and is subject to review and modification by the administrators of the
Medicaid program. The rebate per unit formula is comprised of a basic rebate of
15.1% applied to the average per unit amount of payments we receive on our
product sales and an additional per unit rebate that is based on our current
sales price compared to our sales price on an inflation adjusted basis from a
designated base period. We multiply the rebate amount per unit by the estimated
rebate units to arrive at the reserve for the period. This reserve is deducted
from gross sales in the determination of net sales. Effective January 1, 2008,
the amount we rebate for each Acthar vial dispensed to a Medicaid eligible
patient is approximately $2,500 higher than our price to CuraScript SD.
Management believes that the information received from CuraScript SD related to
inventory levels and CuraScript SP related to prescription and shipment data is
reliable, but we are unable to independently verify the accuracy of such data.
The Medicaid rebates associated with end user demand for a period are mostly
paid to the states by the end of the quarter following the quarter in which the
rebate reserve is established.
Government Chargebacks
Certain other government-supported entities such as the Veterans
Administration and Department of Defense are permitted to purchase Acthar from
CuraScript SD for a nominal amount. CuraScript SD charges the significant
discount back to us and reduces subsequent payment to us by the amount of the
approved chargeback. The chargeback approximates our sales price to our
customers. As a result, we recognize nominal, if any, net sales on shipments to
these entities that qualify for the government chargeback. The reduction to
gross sales for a period related to chargebacks is comprised of actual approved
chargebacks originating during the period and an estimate of chargebacks in the
ending inventory of our customers. In estimating the government chargeback
reserve as of the end of a period, we estimate the amount of chargebacks in our
customers' ending inventory using actual average monthly chargeback amounts and
ending inventory balances provided by our largest customers. Chargebacks are
generally applied by customers against their payments to us approximately 30 to
45 days after they have provided appropriate documentation to confirm their sale
to a qualified government-supported entity.
We routinely assess our experience with Medicaid rebates and government
chargebacks and adjust the reserves accordingly. Revisions in the Medicaid
rebate and chargeback estimates are charged to income in the period in which the
information that gives rise to the revision becomes known.
Tricare Rebates
We have established a reserve for rebates related to a health coverage
program called Tricare. On March 17, 2009, the Department of Defense issued
final regulations under the Fiscal Year 2008 National Defense Authorization Act
which interpreted such Act to expand Tricare to include prescription drugs
dispensed by Tricare retail network pharmacies. Our Tricare rebate reserve
reflects this program expansion and is based on estimated Department of Defense
eligible sales multiplied by the Tricare rebate formula. In estimating our
rebate eligible sales, we did not include sales prior to the effective date of
the Department of Defense regulations, based on our interpretation of the
regulations and a pending dispute between an industry coalition and the
Department of Defense. We did not record reserves for retroactive rebates in the
amount of $100,000 for 2008 and $1.2 million for the January-May 2009 timeframe.
Depending on the outcome of this dispute, it is possible that we will need to
increase our rebate reserve relating to Tricare for these amounts.
Co-Pay Assistance Programs
We sponsor co-pay assistance programs for Acthar patients which are
administered by the National Organization for Rare Disorders ("NORD"). The
payments made under our co-pay assistance programs are accounted for as a
reduction of gross sales.
Product Returns
We supply replacement product to CuraScript SD on product returned between
one month prior to expiration to three months post expiration. Returns from
product lots are exchanged for replacement product, and estimated costs for such
exchanges, which include actual product material costs and related shipping
charges are included in cost of sales. Product returns have been insignificant
since we began utilizing the services of CuraScript SD to distribute Acthar.
Shelf-Stock Adjustment Credit
Under our distribution agreement with CuraScript SD, if the price of Acthar
is reduced, CuraScript SD will receive a shelf-stock adjustment credit based
upon the amount of product in their inventory at the time of the price
reduction. Any reduction in the selling price of Acthar is at our discretion. To
date, there have been no such price reductions.
At September 30, 2009 and December 31, 2008, sales-related reserves included
in the accompanying Consolidated Balance Sheets were as follows (in thousands):
September 30, December 31,
2009 2008
Medicaid rebates $ 12,492 $ 11,406
Tricare rebates 1,400 -
Government chargebacks 73 164
Product returns - 255
$ 13,965 $ 11,825
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Inventories
As of September 30, 2009, our net raw material, work-in-process and finished
goods inventories totaled $3.4 million. We maintain inventory reserves primarily
for excess and obsolete inventory (due to the expiration of shelf life of a
product). In estimating inventory excess and obsolescence reserves, we analyze
(i) the expiration date, (ii) our sales forecasts and (iii) historical demand.
Judgment is required in determining whether the forecasted sales information is
sufficiently reliable to enable us to reasonably estimate excess and obsolete
inventory. If actual future usage and demand for our products is less favorable
than projected, additional inventory write-offs may be required in the future
which would increase our cost of sales in the period of any write-offs. In the
quarter ended September 30, 2009, we reserved $500,000 for a manufactured lot of
Acthar that did not meet specifications. We intend to control inventory levels
of our products purchased by our customers. Customer inventories may be compared
to both internal and external databases to determine adequate inventory levels.
We may monitor our product shipments to customers and compare these shipments
against prescription demand for our individual products.
Intangible and Long-Lived Assets
As of September 30, 2009, our intangible and long-lived assets consisted of
goodwill of $299,000 generated from a merger in 1999, net purchased technology
of $3.4 million related to our acquisition of Doral and $414,000 of net property
and equipment. The costs related to our acquisition of Doral are being amortized
over an estimated life of 15 years. The determination of whether or not
our intangible and long-lived assets are impaired and the expected useful lives
of purchased technology involves significant judgment. Changes in strategy or
market conditions could significantly impact these judgments and require a
write-down of our recorded asset balances and a reduction in the expected useful
life of our purchased technology. Such a write-down of our recorded asset
balances or reduction in the expected useful life of our purchased technology
would increase our operating expenses. In accordance with ASC 350,
Intangibles-Goodwill and Other(formerly SFAS No. 142), we review goodwill for
impairment on an annual basis or whenever events occur or circumstances change
that could indicate a possible impairment may have occurred. Our fair value is
compared to the carrying value of our net assets, including goodwill. If the
fair value is greater than the carrying amount, then no impairment is indicated.
In accordance with ASC 360, Property Plant and Equipment (formerly SFAS
No. 144), we review long-lived assets, consisting of property and equipment and
purchased technology, for impairment whenever events or circumstances indicate
that the carrying amount may not be fully recoverable. Recoverability of assets
is measured by comparison of the carrying amount of the asset to the net
undiscounted future cash flows expected to be generated from the use or
disposition of the asset. If the future undiscounted cash flows are not
sufficient to recover the carrying value of the assets, the assets' carrying
value is adjusted to fair value. As of September 30, 2009, no impairment had
been indicated.
Share-Based Compensation Expense
Effective January 1, 2006, we adopted the fair value recognition provisions
of ASC 718, Compensation-Stock Compensation (formerly SFAS No. 123(R)), using
the modified-prospective transition method. Under the fair value recognition
provisions of ASC 718, share-based compensation cost is estimated at the grant
date based on the fair value of the award and is recognized as expense, net of
estimated pre-vesting forfeitures, ratably over the vesting period of the award.
We selected the Black-Scholes option pricing model as the most appropriate fair
value method for our awards. Calculating share-based compensation expense
requires the input of highly subjective assumptions, including the expected term
of the share-based awards, stock price volatility, and pre-vesting forfeitures.
We estimated the expected term of stock options granted for the three and nine
month periods ended September 30, 2009 and 2008 based on the historical term of
our stock option awards. We estimated the volatility of our common stock at the
date of grant based on the historical volatility of our common stock. The
assumptions used in calculating the fair value of share-based awards represent
our best estimates, but these estimates involve inherent uncertainties and the
application of management judgment. As a result, if factors change and we use
different assumptions, our share-based compensation expense could be materially
different in the future. In addition, we are required to estimate the expected
pre-vesting forfeiture rate and only recognize expense for those shares expected
to vest. We estimate the pre-vesting forfeiture rate based on historical
experience. If our actual forfeiture rate is materially different from our
estimate, our share-based compensation expense could be significantly different
from what we have recorded in the current period.
Our net income for the three and nine month periods ended September 30, 2009
included $669,000 and $2.4 million, respectively, of share-based compensation
expense related to employees and non-employee members of our board of directors.
Our net income for the three and nine month periods ended September 30, 2008
included $635,000 and $3.7 million, respectively, of share-based compensation
expense related to employees and non-employee members of our board of directors.
Lease Termination Liability
We entered into an agreement to sublease laboratory and office space,
including laboratory equipment, at our Hayward, California facility in
July 2000, due to the termination of our then existing drug discovery programs.
The sublease on our Hayward facility expired in July 2006. Our obligations under
the Hayward master lease extend through November 2012. During the fourth quarter
of 2005, the sublessee notified us that they did not intend to extend the
sublease beyond the end of July 2006.
We determined that there was no loss associated with the Hayward facility
when we initially subleased the space, as we expected cash inflows from the
sublease to exceed our rent cost over the term of the master lease. However, we
reevaluated this in 2005 when the sublessee notified us that it would not be
renewing the sublease beyond July 2006. As a result, we computed a loss and
liability on the sublease in the fourth quarter of 2005 in accordance with ASC
840, Leases (which now includes former FIN 27 and FTB 79-15). As of
September 30, 2009 and December 31, 2008, the estimated liability related to the
Hayward facility totaled $1.0 million and $1.2 million, respectively, and is
included in Lease Termination and Deferred Rent Liabilities in the accompanying
Consolidated Balance Sheets. The fair value of the liability was determined
using a credit-adjusted risk-free rate to discount the estimated future net cash
flows, consisting of the minimum lease payments under the master lease, net of
estimated sublease rental income that could reasonably be obtained from the
property. The most significant assumption in estimating the lease termination
liability relates to our estimate of future sublease income. We base our
estimate of sublease income, in part, on the opinion of independent real estate
experts, current market conditions, and rental rates, among other factors.
Adjustments to the lease termination liability will be required if actual
sublease income differs from amounts currently expected. We review all
assumptions used in determining the estimated
liability quarterly and revise our estimate of the liability to reflect changes
in circumstances. Effective November 1, 2007, we subleased 5,000 square feet of
the facility through April 2009 and effective February 1, 2008 we subleased the
remaining 25,000 square feet through the remainder of the term of the master
lease. The 5,000 square foot sublease is currently leased on a month-to-month
basis. These subleases cover a portion of our lease commitment, and all of our
insurance, taxes and common area maintenance. As of September 30, 2009, we are
obligated to pay rent on the Hayward facility of $2.8 million. Over the
remaining term of the master lease, we anticipate that we will receive
approximately $1.3 million in sublease income to be used to pay a portion of our
Hayward facility obligation.
We are also required to recognize an on-going accretion expense representing
the difference between the undiscounted net cash flows and the discounted net
cash flows over the remaining term of the Hayward master lease using the
interest method. The accretion amount represents an on-going adjustment to the
estimated liability. The on-going accretion expense and any revisions to the
liability are recorded in Selling, General and Administrative expense in the
accompanying Consolidated Statements of Income.
Income Taxes
We make certain estimates and judgments in determining income tax expense for
financial statement purposes. These estimates and judgments occur in the
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