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| QCOR > SEC Filings for QCOR > Form 10-K on 27-Feb-2013 | All Recent SEC Filings |
27-Feb-2013
Annual Report
Form 10-K. We expressly disclaim any intent or obligation to update any
forward-looking statements after the date hereof to conform such statements to
actual results or to changes in our opinions or expectations. Readers are urged
to carefully review and consider the various disclosures made by us, which
attempt to advise interested parties of the risks, uncertainties, and other
factors that affect our business, set forth in detail in Item 1A of Part I,
under the heading "Risk Factors."
The following discussion and analysis should be read in conjunction with our
consolidated financial statements and the related notes to those statements
contained elsewhere in this Annual Report on Form 10-K.
Overview
Questcor is a biopharmaceutical company focused on the treatment of patients
with serious, difficult-to-treat autoimmune and inflammatory disorders. Our
primary product is H.P. Acthar® Gel (repository corticotropin injection), or
Acthar, an injectable drug that is approved by the U.S. Food and Drug
Administration, or FDA, for the treatment of 19 indications. Of these 19 FDA
approved indications, we currently generate substantially all of our net sales
from the following indications:
• Nephrotic Syndrome (NS): Acthar is indicated "to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus." According to the National Kidney Foundation, nephrotic syndrome can result from several idiopathic type kidney disorders, including idiopathic membranous nephropathy, focal segmental glomerulosclerosis, IgA nephropathy and minimal change disease. Nephrotic syndrome can also occur due to lupus erythematosus. In this Form 10-K, the terms "nephrotic syndrome" and "NS" refer only to the proteinuria in nephrotic syndrome conditions that are covered by the Acthar label of approved indications.
• Multiple Sclerosis (MS): Acthar is indicated "for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease."
• Infantile Spasms (IS): Acthar is indicated "as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age." We continue to support this vulnerable patient population. We believe that a significant percentage of the $262 million in free drug we have provided through the National Organization of Rare Disorders, from September 2007 through December 31, 2012, has been used to treat IS. We support the IS community through other initiatives. In February 2012, we were awarded the first-ever Corporate Citizenship Award presented by the Child Neurology Foundation. This award honors our long-term commitment to support the child neurology community as well as our specific efforts to fund education and research related to IS.
• Rheumatology Related Conditions: Acthar is approved for the following rheumatology related conditions: (i) Collagen Diseases: Acthar is indicated "during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, systemic dermatomyositis (polymyositis)" and (ii) Rheumatic Disorders: Acthar is indicated as "adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), and Ankylosing spondylitis."
We continue to explore additional markets for other on-label indications. In
addition, we are exploring the possibility of pursuing FDA approval for
indications not currently on the Acthar label that are related to the treatment
of other serious, difficult-to-treat autoimmune and inflammatory disorders
having high unmet medical need.
Our other product is Doral® (quazepam), which is indicated for the treatment of
insomnia characterized by difficulty in falling asleep, frequent nocturnal
awakenings, and/or early morning awakenings. We own the U.S. rights to and have
modest sales of Doral.
Results of Operations
Years Ended December 31, 2012, 2011 and 2010
Net Sales. Net sales, which we derive from our sales of Acthar and Doral, were
$509.3 million in 2012, compared to $218.2 million in 2011 and $115.1 million in
2010. The following table sets forth our net sales for the years ended December
31, 2012, 2011 and 2010, respectively (in thousands):
Years Ended December 31,
2012 2011 2010
Revenue $ 582,097 $ 268,827 $ 154,806
Less sales reserves:
Provision for Medicaid rebates 58,205 46,481 37,159
Provision for chargebacks 467 142 106
Provision for Coverage Gap Discount 943 348 -
Provision for Tricare rebates 5,090 1,691 1,202
Co-payment assistance and other 8,100 1,996 1,208
Total sales reserves 72,805 50,658 39,675
Net sales $ 509,292 $ 218,169 $ 115,131
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2012 compared to 2011: Net sales of Acthar increased by approximately 133.8% to
$508.9 million for the year ended December 31, 2012 from $217.7 million in 2011.
The increase in net sales was attributable to increased vial demand from
CuraScript SD, our distributor for Acthar. We shipped 20,741 vials for the year
ended December 31, 2012 as compared to 10,710 vials shipped for the year ended
December 31, 2011. While we do not receive complete information regarding
prescriptions by therapeutic area, we believe increased demand from CuraScript
SD was driven by strong prescription growth in each of our NS and MS therapeutic
areas.
Net sales for the year ended December 31, 2012 were also positively affected by
increases in the price we charge CuraScript SD for Acthar. We increased the
price of Acthar on December 27, 2011 by 6.5% and on May 15, 2012 by 5%, and
currently charge CuraScript SD $28,430 per vial.
Our net sales are also impacted by the amount of our sales reserves, which are
deducted from revenue in the calculation of net sales. During the years ended
December 31, 2010, 2011 and 2012, the largest component of our sales reserves
related to our provision for Medicaid rebates. This provision is impacted by two
factors. First, our business mix across therapeutic areas affects our provision
for Medicaid rebates since the percentage of patients that are enrolled in
Medicaid varies by therapeutic area. Specifically, a lower percentage of adults
are enrolled in Medicaid than are infants. As such, the growth in our NS and MS
sales relative to IS sales has resulted in an overall lower percentage of sales
being attributable to patients enrolled in Medicaid. Second, the rebate amount
for Acthar affects our provision for Medicaid rebates. For the year ended
December 31, 2012, we recorded a provision of 12.5% of our gross revenue for
sales-related reserves, a decrease from the 18.8% in the year ended December 31,
2011. During the years ended December 31, 2010, 2011 and 2012, the Medicaid
rebate amount equaled 100% of the Average Manufacturer Price, or AMP, of Acthar
which approximates the amount we charge to CuraScript SD. As such, we did not
generate any net sales in connection with Medicaid business. During the first
quarter of 2013, the Medicaid rebate amount for Acthar was reset from 100% of
the AMP of Acthar to the basic rebate amount of 23.1% of AMP.
We believe that approximately three-quarters of our growth in net sales from
2011 to 2012 was due to increased vial shipments, with the remainder of our net
sales growth being due to the increase in the percentage of our product sales
that are not subject to Medicaid rebates as described above, as well as
increased product pricing. However, it is difficult to ascribe the sources of
net sales growth to these individual factors as the factors might not be
independent.
We believe that Acthar represents a promising potential therapy for patients
suffering from the difficult-to-treat, on-label medical conditions for which we
currently promote Acthar. Acthar, however, remains relatively unknown to
physicians who practice in the relevant medical specialties. As a result, we
have expanded our sales force in order to increase our ability to educate such
physicians about Acthar's potential benefit to their patients. It is unclear
whether this will continue to result in increased net sales. The process of
significantly expanding a sales force in the biopharmaceutical industry is
complex. We modify and re-allocate individual sales territories across our
enlarged sales force, which can cause temporary disruptions in our selling
efforts. Additionally, while the cost of our new sales representatives impacts
our operating expenses immediately, there can be a delay in the expected ability
of our new representatives to increase our net sales due to the time it takes
for us to train the new representatives and for the new representatives to
establish professional relationships with prescribing physicians within their
territories.
Acthar orders may be affected by several factors, including inventory levels at
specialty and hospital pharmacies, greater use of patient assistance programs,
the overall pattern of usage by the health care community, including Medicaid
and government-supported entities, the use of alternative therapies, and the
reimbursement policies of insurance companies. Our specialty distributor ships
Acthar to specialty pharmacies and hospitals to meet end user demand. We track
our own Acthar shipments daily, but those shipments vary compared to end user
demand and because of changes in inventory levels at specialty pharmacies and
hospitals. As a result of the variation in order patterns, in channel inventory
levels may be positively or
negatively affected. For example, in late December 2012, we received and shipped
two orders of Acthar for a total of 360 vials. We believe that distribution
channel inventory was at the high end of the normal historic range as of
December 31, 2012.
2011 compared to 2010: Net sales of Acthar increased by approximately 90% to
$217.7 million for the year ended December 31, 2011 from $114.7 million for the
year ended December 31, 2010. The increase in net sales was due to an increase
in the number of Acthar vials shipped from 6,696 vials shipped in 2010, up to
10,710 vials shipped in 2011, a reduction in the per vial rebate liability for
both Medicaid and TRICARE, and a reduction in the number of Medicaid fee for
service prescriptions. This increase was partially offset by an increase in our
Medicaid Managed Care Organization rebate, which became effective on March 23,
2010.
Our increased detailing efforts and our initiatives to educate MS specialists
about the treatment benefits of Acthar resulted in a significant increase in
sales of Acthar to treat select MS exacerbation patients for the year ended
December 31, 2011 as compared to the same period in 2010. During the year ended
December 31, 2011, new paid Acthar prescriptions processed by our reimbursement
support center for the treatment of MS exacerbations increased by approximately
155% as compared to 2010.
Cost of Sales and Gross Profit
Years Ended December 31,
2012 2011 2010
Cost of sales $ 28,555 $ 12,459 $ 8,013
Gross profit 480,737 205,710 107,118
Gross margin 94 % 94 % 93 %
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Cost of sales was $28.6 million for the year ended December 31, 2012, as
compared to $12.5 million for 2011 and $8.0 million for 2010. We include in cost
of sales material costs, packaging, warehousing and distribution, product
liability insurance, royalties, quality control (which primarily includes
product stability testing), quality assurance and reserves for excess or
obsolete inventory. Our gross margin and gross profit was 94% and $480.7
million, respectively, in 2012, as compared to 94% and $205.7 million,
respectively, in 2011 and 93% and $107.1 million, respectively, in 2010. The
increase in gross profit dollars is due to continued growth in paid
prescriptions for all of our indications. The increase in cost of sales was
primarily due to an increase in net sales coupled with an increase in the cost
for outside product potency testing and an increase in royalties on Acthar net
sales, offset by a decrease in the proportionate amount of distribution costs
relative to net sales. We continue to expect our cost of sales, in absolute
dollars, to increase in future periods due to increased costs associated with
outside product potency testing, product stability testing and, in the event of
increased net sales, higher royalty payments. The manufacturing process for
Acthar is complex and problems may arise during manufacturing for a variety of
reasons, including equipment malfunction, failure to follow specific protocols
and procedures, problems with raw materials, natural disasters, and
environmental factors.
Selling and Marketing. Selling and marketing expenses were $114.1 million for
the year ended December 31, 2012, as compared to $56.7 million in 2011 and $31.5
million in 2010. The increase of $57.4 million in 2012 as compared to 2011 is
due primarily to increases in headcount-related costs and costs associated with
our expanded sales and marketing effort. We primarily include in sales and
marketing expenses headcount-related costs, promotional costs and physician
program costs. We have expanded our sales force and expect selling and marketing
expenses to increase in future periods.
The increase in selling and marketing expenses of $25.2 million in 2011 as
compared to 2010 was also due primarily to increases in headcount-related costs
and costs associated with our expanded sales and marketing effort.
General and Administrative. General and administrative expenses were $33.6
million for the year ended December 31, 2012, as compared to $17.7 million in
2011 and $10.3 million in 2010. The increase of $15.9 million in 2012 as
compared to 2011, as well as the increase of $7.4 million in 2011 as compared to
2010, is due primarily to increases in headcount and headcount-related costs to
support our growth, including increased bonus compensation for our
bonus-eligible employees, and increased legal costs.
Research and Development. Research and development expenses were $34.3 million
in 2012, as compared to $16.8 million in 2011 and $10.9 million in 2010. The
increase of $17.5 million in research and development expenses in 2012 as
compared to 2011 was primarily due to increases in headcount and
headcount-related costs to support our efforts to explore the use of Acthar as a
therapeutic alternative for the treatment of NS and costs incurred associated
with the following clinical studies: (1) the initiation of our Phase 4 dose
response clinical trial for idiopathic membranous nephropathy, (2) the
initiation of our pilot safety and efficacy study of Acthar in patients with
diabetic nephropathy, and (3) the initiation of our study exploring
the efficacy, safety and pharmacodynamics of Acthar in system lupus erythematosus. Costs included in research and development also include costs associated with the funding of medical research projects to better understand the therapeutic benefit of Acthar in current and new therapeutic applications, product development efforts and regulatory compliance activities. We manage and evaluate our research and development expenditures generally by the type of costs incurred. We generally classify and separate research and development expenditures into amounts related to medical affairs, regulatory, product development and manufacturing costs. Such categories include the following types of costs:
• Medical Affairs Costs - Medical affairs costs, which include
activities related to medical information in support of Acthar and
its related indications.
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• Regulatory Costs - Regulatory costs, which include compliance and all FDA interactions.
• Product Development Costs - Product development costs, which include contract research organization costs and study monitoring costs.
• Manufacturing Costs - Manufacturing costs, which include costs
related to production scale-up and validation, raw material
qualification and stability studies.
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For the year ended December 31, 2012, approximately 42% of our research and
development expenditures were for medical affairs costs, 8% was spent on
regulatory costs, 39% was spent on product development costs, and approximately
11% was spent on manufacturing costs.
For the year ended December 31, 2011, approximately 36% of our research and
development expenditures were for medical affairs costs, 12% was spent on
regulatory costs, 37% was spent on product development costs, and approximately
15% was spent on manufacturing costs.
For the year ended December 31, 2010, approximately 43% of our research and
development expenditures were for medical affairs costs, 25% was spent on
regulatory costs, 12% was spent on product development costs, and approximately
20% was spent on manufacturing costs.
We plan to continue to expand our research and development efforts to support
the use of Acthar as a therapeutic alternative for the treatment of NS. In 2011,
we started a Phase 4 dose response clinical trial for idiopathic membranous
nephropathy and in 2012, we started a pilot safety and efficacy study of Acthar
in patients with diabetic nephropathy and proteinuria. These clinical trials
will result in a significant increase in research and development expenses
through 2013. We may also pursue clinical trials to evaluate the use of Acthar
to treat other therapeutic uses, including conditions that are not currently on
the label of approved indications for Acthar.
The expenditures that will be necessary to execute our development plans are
subject to numerous uncertainties, which may affect our research and development
expenditures and capital resources. For instance, the duration and the cost of
clinical trials may vary significantly depending on a variety of factors
including a trial's protocol, the number of patients in the trial, the duration
of patient follow-up, the number of clinical sites in the trial, and the length
of time required to enroll suitable patient subjects. Even if earlier results
are positive, we may obtain different results in later stages of development,
including failure to show the desired safety or efficacy, which could impact our
development expenditures for a particular indication. Although we spend a
considerable amount of time planning our development activities, we may be
required to deviate from our plan based on new circumstances or events or our
assessment from time to time of a particular indication's market potential,
other product opportunities and our corporate priorities. Any deviation from our
plan may require us to incur additional expenditures or accelerate or delay the
timing of our development spending. Furthermore, as we obtain results from
trials and review the path toward regulatory approval, we may elect to
discontinue development of certain indications or product candidates, in order
to focus our resources on more promising indications or candidates. As a result,
the amount or ranges of cost and timing to complete our product development
programs and each future product development program is not estimable.
Share-based compensation costs. Total share-based compensation costs for the
years ended December 31, 2012, 2011 and 2010 were $15.8 million, $7.3 million
and $3.7 million, respectively. This increase was primarily due to a significant
increase in the number of employees participating in our equity compensation
programs. For the year ended December 31, 2012, we granted options to employees
and non-employee directors to purchase approximately 1,899,909 shares of our
common stock at a weighted average exercise price of $36.16 per share, which was
equal to the weighted average of the fair market value of our common stock on
the date of each grant. In addition to stock options, we also granted restricted
stock awards to certain employees. The total share-based compensation costs
related to these restricted stock awards for the years
ended December 31, 2012, 2011 and 2010 were $1.8 million, $163,000 and $50,000, respectively. The following table sets forth our share-based compensation costs for the years ended December 31, 2012, 2011 and 2010, respectively (in thousands):
Years Ended December 31,
2012 2011 2010
Selling and marketing $ 5,360 $ 4,236 $ 952
General and administrative 7,467 1,884 1,832
Research and development 2,965 1,206 955
Total share-based compensation expense $ 15,792 $ 7,326 $ 3,739
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Total Other Income. Total other income for the year ended December 31, 2012 was $0.7 million, as compared to $0.6 million for 2011 and $0.5 million for 2010. The increase in total other income of $0.1 million in 2012 as compared to 2011 was the result of an increase in the average cash balances on hand for 2012 as compared to 2011 resulting in higher interest income. The increase in total other income of $0.1 million in 2011 as compared to 2010 was the result of an increase in miscellaneous income offset by a lower yield on our cash, cash equivalent and short-term investment balances year over year.
Income tax expense. Income tax expense for the years ended December 31, 2012,
2011 and 2010 was $99.6 million, $34.2 million and $19.3 million, respectively,
and our effective tax rate for financial reporting purposes was approximately
33.5%, 30.0% and 35.5%, respectively. The increase in our effective income tax
rate in 2012 as compared to 2011 is due to an increase in nondeductible expense,
the absence of research and development tax credits in 2012, and the one-time
tax credit recorded in 2011 for the costs incurred in obtaining the orphan drug
designation. The decrease in the effective tax rate in 2011 as compared to 2010
is due to the reduction in our state income tax rate because beginning in 2011,
California allows for a single apportionment factor and most of our sales are
sourced outside of California, and finally, we recorded a one-time tax credit
during 2011 for the costs incurred in obtaining the orphan drug designation.
Liquidity and Capital Resources
Cash and cash equivalents, short-term investments and working capital as of
December 31, 2012 and 2011, respectively, were as follows (in thousands):
Financial Assets:
Years Ended December 31,
2012 2011
Cash and cash equivalents $ 80,608 $ 88,469
Short-term investments 74,705 121,680
Cash, cash equivalents and short-term investments $ 155,313 $ 210,149
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Select measures of liquidity and capital resources:
Years Ended December 31,
2012 2011
Current assets $ 237,276 $ 265,600
Current liabilities 90,399 55,721
Working Capital $ 146,877 $ 209,879
Current Ratio 2.62 4.77
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Until required for use in our business or returned to shareholders through our
dividend, share repurchase program or other method, we invest our cash reserves
in money market funds and high quality commercial, corporate and U.S. government
and agency bonds in accordance with our investment policy. The objective of our
investment policy is to preserve capital, provide liquidity consistent with
forecasted cash flow requirements, maintain appropriate diversification and
generate returns relative to these investment objectives and prevailing market
conditions.
The decrease in cash, cash equivalents and short-term investments was primarily
due to the repurchase of 6,759,861 shares of our common stock through our
approved stock repurchase plan for $261.8 million, offset by an increase in net
sales
and the related cash generated from operations. The decrease in our working
capital was primarily due to decreases in our cash, cash equivalents and
short-term investments, offset by increases in our accounts receivable,
inventories, and sales-related reserves.
Our collection terms on our accounts receivable are net 30 days, with
approximately 100% of our accounts receivable and net sales generated by our
distributor for Acthar, CuraScript SD, which in turn sells Acthar primarily to
specialty pharmacies.
We expect continued growth in our research and development expenses. However, we
anticipate that cash generated from operations and our existing cash, cash
equivalents and short-term investments should provide us adequate resources to
fund our operations as currently planned for the foreseeable future.
During the period from October 1, 2012 through December 31, 2012, we repurchased
the following shares of our common stock:
Total Number of
. . .
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