BUSINESS
Overview
We are a specialty pharmaceutical company focused on prescription products that
treat disorders of the CNS. The CNS market consists of three major segments:
neurology, pain and psychiatry. We currently focus on neurology, a segment where
a limited number of high-prescribing physicians write a significant number of
the prescriptions for neurology products. The top two areas of practice focus of
neurologists are epilepsy and migraine.
Our product portfolio includes four products, Diastat and Mysoline, which are
used to treat epilepsy, and Migranal and D.H.E. 45, which are used to treat
migraine. Our 96-person nationwide field sales organization promotes our
products to high-prescribing epilepsy and migraine specialists. We intend to
increase prescription demand for our growth products, Diastat and Migranal,
through targeted sales and marketing efforts and to develop enhancements for our
current products. In addition, we intend to leverage our presence in the CNS
market through the acquisition, development and commercialization of late-stage
development product candidates and through the acquisition of additional
marketed products.
The concentration of high-prescribing physicians in the neurology market enables
us to promote our products effectively with a small, dedicated sales and
marketing organization and a limited corporate infrastructure. During 2002, the
14,800 neurologists and pediatric neurologists in the United States collectively
wrote prescriptions for $1.5 billion of the products used to treat epileptic
seizures and $354 million of the products used to treat migraines. Our field
sales organization promotes our products to 6,900 of the highest-prescribing
physicians in this group. These 6,900 high-prescribing neurologists collectively
wrote 93% of the prescriptions for epilepsy and migraine products among all
14,800 neurologists and pediatric neurologists in 2002. We have designed our
corporate infrastructure to support our field sales organization, to identify
and pursue the acquisition of late-stage development product candidates and
additional marketed products and to lead our product development and enhancement
efforts. We utilize third parties to manufacture and distribute our products and
to support our product development and enhancement efforts.
Our epilepsy products, Diastat and Mysoline, are used in the treatment of
seizures principally associated with epilepsy. We acquired Diastat and Mysoline
in 2001 from Elan. Diastat is currently the only drug approved in the United
States for the acute treatment of seizures outside of a hospital setting and is
the subject of a patent which expires in September 2013. Mysoline has been used
since the early 1950s for the chronic treatment of seizures associated with
epilepsy and is highly complementary to our marketing efforts for Diastat.
Our migraine products, Migranal and D.H.E. 45, contain the active ingredient
dihydroergotamine and represent safe and effective second-line therapies for the
acute treatment of migraine. We acquired Migranal and D.H.E. 45 in 2002 from
Novartis. Migranal is the subject of a patent which expires in December 2009.
D.H.E. 45 has been used since the mid-1940s, has been a standard of care for
many years for the acute treatment of migraine and is highly complementary to,
and benefits from, our marketing efforts for Migranal.
We believe that the changing pharmaceutical industry landscape will present
significant opportunities for us to acquire additional marketed and late-stage
development product candidates. Larger pharmaceutical companies are shifting
their sales and marketing efforts away from smaller products toward products
with higher revenue potential and new product launches. As a result, an
increasing number of smaller products that may have growth potential are
receiving little or no attention and present potentially attractive acquisition
opportunities for us. Biotechnology companies developing CNS product candidates
also are looking for partners to assist with the commercialization of their
products and associated costs, including late-stage development costs. We
continually evaluate opportunities to acquire rights to these types of products
and product candidates, although currently we have no specific agreements with
respect to such acquisitions. We are pursuing product enhancements for both
Diastat and Migranal that, subject to regulatory approval, we believe will
provide additional patient, physician and distribution channel benefits.
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Our Strategy
Our objective is to capitalize on our management team's experience acquiring,
developing and marketing pharmaceutical products. We intend to become a leading
specialty pharmaceutical company focused on disorders of the CNS in the United
States. Specifically, our strategy is to:
Increase prescription demand for our growth products, Diastat and
Migranal. We believe there are significant opportunities to
increase prescription demand for Diastat and Migranal. Diastat is
the only product approved in the United States for the acute
treatment of seizures associated with epilepsy outside of a
hospital setting. Diastat is safe and effective and has
significant quality-of-life and cost advantages. Although
one-third of our targeted physician audience wrote 67% of all
Diastat prescriptions during 2002, the remaining two-thirds of
these physicians did not prescribe Diastat. We intend to increase
prescription demand for Diastat by promoting to our targeted
physicians the benefits of including Diastat as part of the
standard treatment regimen for their epilepsy patients. Migranal
is safe and effective for the acute treatment of migraine. We
intend to increase prescription demand for Migranal by promoting
to our targeted physicians the benefits of prescribing Migranal
for their migraine patients who do not experience effective relief
with first-line migraine therapies.
Leverage our presence in the CNS market through the acquisition of
late-stage development product candidates. We intend to build a
product pipeline by acquiring late-stage development product
candidates that, subject to regulatory approval, can be marketed to
our targeted physician audiences. We target product candidates that,
at a minimum, are in Phase II clinical studies. We have developed
valuable relationships with third-party consultants and contract
research organizations that we intend to utilize to support our
advancement of late-stage development product candidates through the
development and approval process.
Leverage our presence in the CNS market through the acquisition of
additional marketed products. We intend to enhance our growth
and leverage our organization by acquiring additional FDA-approved
products that can be marketed to our targeted physician audiences.
We believe that a growing number of opportunities to acquire
neurology products will arise due to the increasing emphasis by
larger pharmaceutical companies on products with higher revenue
potential and new product launches.
Maximize the value of our products by developing product
enhancements. We intend to expand sales of our current products by
developing product enhancements, such as new delivery systems, new
formulations and new dosage strengths, and by conducting targeted
post-approval clinical studies. We currently are developing product
enhancements for Diastat and Migranal that, subject to regulatory
approval, we believe will provide additional patient, physician and
distribution channel benefits. We believe that product enhancements
represent attractive ways to expand our business because they
typically are less costly, less risky and require less time than most
other product development efforts. We have relationships with third
parties to support development of our product enhancements.
Our Market Focus-Disorders of the Central Nervous System
Our market focus is on disorders of the CNS, which includes neurologic
disorders, pain and psychiatric disorders. Our current focus within the CNS
market is neurology, or the treatment of diseases that affect the nervous
system. We currently focus on neurology, a segment where a limited number of
high-prescribing physicians write a significant number of prescriptions for
neurology products. The top two areas of practice focus of neurologists are
epilepsy and migraine. Our products, Diastat and Mysoline, are used in the
treatment of seizures principally associated with epilepsy. Sales of products in
the United States used to treat epileptic seizures totaled $5.4 billion in 2002
and grew at an average annual rate of 24% from 1998 to 2002. Our products,
Migranal and D.H.E. 45, are used in the treatment of migraines. Sales of
products used to treat migraines in the United States totaled $1.8 billion in
2002 and grew at an average annual rate of 12% from 1998 to 2002.
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Epilepsy
Epilepsy is a chronic disorder characterized by abnormal electrical discharges
in the brain. These abnormal electrical discharges result in seizures, the
clinical manifestation of epilepsy. Epilepsy is one of the most common
neurologic disorders in the United States, affecting 2.5 million people in 2000
with an estimated 181,000 new cases diagnosed each year. Most seizures end
within two minutes; however, those that do not are unpredictable in length. The
longer a seizure lasts, the more difficult it becomes to treat and the greater
the risk of injury and death to the patient.
A wide variety of antiepileptic drugs are available to prevent and treat
seizures. These drugs are typically administered orally on a daily basis. Most
patients receive a regimen of a single drug or a combination of several
antiepileptic drugs. Nevertheless, approximately 30% of, or 750,000, patients
with epilepsy have inadequate seizure control or are resistant to drug therapy
and suffer from seizures, which we refer to as breakthrough seizures. These
patients may have frequent visits to the emergency room and admissions to the
hospital because of their breakthrough seizures. Even patients for whom
antiepileptic drugs provide adequate control are still at risk of breakthrough
seizures.
If uncontrolled, breakthrough seizures can progress into a single prolonged
seizure, a cluster of seizures or status epilepticus, a prolonged seizure or
series of intermittent seizures without recovery of consciousness that lasts
more than 30 minutes. Status epilepticus occurs an estimated 152,000 times each
year in the United States and is a neurologic emergency. Estimates of the risk
of death from status epilepticus vary widely, but have been as high as 53%.
While status epilepticus can be devastating, even brief seizures have
significant consequences, including the potential for physical injury and brain
damage to the patient and the emotional distress inflicted upon family members
and caregivers witnessing the event.
As a result of the significant risks of injury and death associated with
prolonged seizures and status epilepticus, the goal of therapy is to stop the
seizure as quickly as possible. Unfortunately, effective treatments for
prolonged seizures in the United States historically have been available only in
a hospital setting. Depending on the distance between the location where the
seizure occurs and the nearest hospital, the delay between the onset of a
prolonged seizure and the initiation of treatment can be significant. In one
study, the time from the onset of the seizure to the initiation of treatment at
the hospital averaged 85 minutes. Once in the emergency room, physicians tend to
treat seizures aggressively, usually with benzodiazepines delivered
intravenously. When the seizure has stopped, the patient may remain heavily
sedated for many hours as a result of the seizure itself and the longer-term
effects of the medication used to stop the seizure.
In the 1980s, several patient advocacy groups and a nationwide group of
neurologists specializing in the treatment of epilepsy began lobbying drug
manufacturers to develop an alternative treatment for seizures that could be
administered by caregivers outside a hospital setting. Initial work focused on
developing an alternative to the intravenous route for delivering
benzodiazepines. Oral or sublingual administration was considered impractical
for seizure patients because of the dangers of the patient choking on the
medication, as well as the difficulty of administering the medication if the
patient will not, or cannot, cooperate. Intramuscular administration through
injection was also rejected because it results in erratic drug absorption and
has been associated with a condition known as necrosis, or tissue death, at the
injection site. For several years, physicians in Europe had been using diazepam,
a benzodiazepine in a liquid solution delivered rectally, to treat prolonged
seizures by a caregiver at home. One limitation of this approach, however, is
that it is difficult to contain the liquid solution while the seizing patient's
body absorbs the drug. As a result, U.S. efforts focused on developing a better
delivery system that would permit more complete absorption of the drug by the
patient. Diastat, approved by the FDA in 1997, was the culmination of these
efforts.
Migraine
Migraine is a neurologic disorder characterized by recurrent headache attacks
where the pain most often occurs on one side of the head. Migraines are usually
accompanied by various combinations of symptoms,
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including nausea and vomiting, distorted vision, and sensitivity to light and
sound. The biochemical mechanism underlying migraines remains to be fully
understood. However, recent advances in migraine research have identified the
neurotransmitter, serotonin (5-hydroxytryptamine, or 5-HT), as a key mediator in
the generation of migraine. There is much evidence to suggest that the principal
factor in migraine and its associated symptoms are blood flow changes in the
brain. Migraines affect approximately 28 million people in the United States,
nearly 13% of the total U.S. population. Migraines are episodic and vary among
patients. The average migraine patient experiences two migraines per month.
A variety of migraine drugs are available to abort migraines. These drugs can be
administered orally, nasally or via injection and are taken on an as needed
basis. Two important prescription drug classes for the abortive treatment of
migraines are triptans and ergotamines. Triptans and ergotamines relieve the
migraine pain by mediating the constriction of blood vessels in the brain,
referred to as vasoconstriction. However, triptans and ergotamines can cause
side effects, including nausea, dizziness, neck or chest tightness, warm or cold
sensations and muscle weakness. Dihydroergotamine is a derivative of ergotamine
which exhibits a more selective vasoconstriction that results in reduction of
the migraine pain with fewer effects than ergotamines. Of the 16 million people
who receive a prescription drug for migraines each year, approximately 25%, or
4 million, of them do not experience effective relief from first-line therapies.
The leading first-line migraine therapies prescribed by neurologists are the
triptan class of drugs. Triptans generally are prescribed as the first-line
therapy for migraine because they are fast-acting compared to other available
therapies. Migranal and D.H.E. 45, both of which are dihydroergotamines, have a
mechanism of action that is broader than the triptan class of drugs and other
ergotamines and therefore represent a safe and effective second-line therapy for
patients who are not experiencing effective relief from triptan-based drugs.
Migranal is delivered through a nasal spray, while D.H.E. 45 can be administered
via intravenous, intramuscular of subcutaneous injection.
Our Products
Our four products include two products, Diastat and Mysoline, which are used to
treat epilepsy, and two products, Migranal and D.H.E. 45, which are used to
treat migraine. Our strategy is to increase prescription demand for Diastat and
Migranal by promoting these products to our targeted physicians. Diastat is
patented into September 2013, and Migranal is patented into December 2009.
Mysoline and D.H.E. 45 are not protected by patents. The following table
provides more information on each of our products:
Patent
Product Indication Administration / Delivery Expiration
Diastat Epilepsy Rectally administered gel for the acute treatment of 2013
epilepsy patients age two years and above experiencing
seizures.
Migranal Migraine Nasal spray for the acute treatment of migraines. 2009
D.H.E. 45 Migraine Intravenous, intramuscular or subcutaneous injection N/A
for the acute treatment of migraines.
Mysoline Epilepsy Oral tablets used alone or in combination with other N/A
therapies in the chronic control of epileptic seizures
for patients age eight and above; also used off-label
to treat essential tremor.
Diastat
Diastat is the only drug approved in the United States for the acute treatment
of seizures outside of a hospital setting. Diastat is a rectally administered
gel for patients age two and above experiencing breakthrough seizures. We
acquired our rights to Diastat from Elan in March 2001. Diastat serves a
previously unmet need for patients suffering from a breakthrough seizure by
treating the patient immediately at the location where the seizure occurs. For
most patients, the ability to receive treatment wherever the seizure occurs
significantly shortens the time between the onset of the seizure and the
administration of effective treatment. This, in
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combination with Diastat's rapid onset of action, generally between five and 15
minutes, results in an increased likelihood of shortening the seizure, thereby
reducing the risks of irreparable injury and death to the patient. Diastat also
reduces the need for patients and their families to visit an emergency room.
When administered within five to ten minutes of the onset of a seizure, Diastat
has been shown to reduce the number of emergency room visits by 67%. Diastat has
an excellent safety profile, with the most noticeable side effect being
drowsiness. When compared to the costs of treating a prolonged seizure in an
emergency room, Diastat also represents a significant cost savings to patients,
government entities and private health insurers.
Diastat provides significant quality of life benefits for epilepsy patients and
their families. Diastat enables patients and their families to enjoy greater
freedom to travel away from home and to live away from large metropolitan areas
where most hospitals are located because they have a treatment option in the
event of a breakthrough seizure. Diastat also provides family members and
caregivers with greater comfort knowing that their loved one has an effective
treatment that can be administered at the location where the seizure occurs.
During 2002, one-third of our targeted prescriber audience of 6,900 neurologists
and pediatric neurologists wrote 67% of the total Diastat prescriptions. The
remaining two-thirds did not prescribe Diastat. We believe that through focused
and consistent promotion of the benefits of including Diastat as part of the
standard treatment regimen for their epilepsy patients, we can continue to
increase the use of Diastat among our targeted prescriber audience.
Retail prescriptions for Diastat have grown steadily since its launch by Elan in
October 1997 and have continued to grow since we acquired Diastat in March 2001.
Total retail prescriptions increased 29.4% during the 12 months after our
re-launch of promotion in October 2001. Retail prescriptions for Diastat have
continued their growth trends into 2003, with total retail prescriptions in June
2003 reaching an all-time high of 9,962 while increasing 25.9% during the 12
months ended June 30, 2003.
Migranal
Migranal is a nasal spray used to treat migraines. We acquired our rights to
Migranal from Novartis in June 2002. Migraines affect approximately 28 million
people in the United States, nearly 13% of the total U.S. population. Sales of
products used to treat migraines in the United States totaled $1.8 billion in
2002 and grew at an average annual rate of 12% from 1998 to 2002. Of the 16
million people who receive a prescription drug for migraines each year,
approximately 25%, or 4 million people, do not experience effective relief from
first-line therapies. The leading first-line migraine therapies prescribed by
neurologists are the triptan class of drugs. Migranal has a mechanism of action
that is broader than the triptan class of drugs. Our strategy is to promote
Migranal to our targeted physicians as a safe and effective therapeutic option
for migraine patients who do not experience effective relief with first-line
migraine therapy.
Migranal was initially launched by Novartis in January 1998, but had no
significant promotional activity from 1999 until our relaunch in October 2002.
As a result of our sales force relaunching promotional activity, the historical
decline of Migranal total retail prescriptions has slowed by 53% to a 6.4%
decline for the nine months since our relaunch compared to a 13.5% decline for
the nine months before our relaunch. The decline of new retail prescriptions,
which is a leading indicator of demand, has slowed by 97% to a 0.4% decline for
the nine months since our relaunch compared to a 11.6% decline for the nine
months before our relaunch. We believe that through focused and consistent
promotion of the benefits of using Migranal as an alternative therapy for
patients who do not experience effective relief with triptans, we can increase
the use of Migranal among our targeted prescriber audience.
D.H.E. 45
D.H.E. 45 is an injectable product that can be administered intravenously,
intramuscularly or subcutaneously to treat migraines. We acquired our rights to
D.H.E. 45 from Novartis in June 2002.
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D.H.E. 45 has been used since the mid-1940s and has been a standard of care for
many years for the acute treatment of migraine. The majority of D.H.E. 45
ampules are administered in headache clinics, medical offices or emergency
rooms. We promote D.H.E. 45 together with Migranal as a proven treatment for
migraine patients who do not experience effective relief from triptan-based
drugs. D.H.E. 45 is not protected by a patent and two abbreviated new drug
applications for generic equivalents to D.H.E. 45 were approved by the FDA in
the second quarter of 2003. D.H.E. 45 has experienced slowly declining
prescription trends for many years. In August 2003, the first of the generics
for D.H.E. 45 was launched by Paddock Laboratories, Inc. We expect the launch of
generics to increase the rate of prescription decline and to affect adversely
our future net sales of D.H.E. 45.
Mysoline
Mysoline, our brand name for primidone, is an oral prescription medication that
has been used since the early 1950s for the chronic treatment of seizures
associated with epilepsy. We acquired our rights to Mysoline from Elan in April
2001. It is used alone and in combination with other anticonvulsant drugs.
Mysoline is also a frequently prescribed therapy for the treatment of essential
tremor (although Mysoline is not indicated for essential tremor). Essential
tremor is considered the most common neurologic movement disorder.
Mysoline is not protected by a patent and several generic versions of the
product are available. Mysoline is, however, included in the FDA list of narrow
therapeutic index drugs. These drugs are characterized by sensitivity to slight
formulation changes between different manufacturers that can lead to different
therapeutic effects and adverse events in patients. In the case of Mysoline and
most other antiepileptic drugs, the difficulty of finding a drug regimen that
can control seizures effectively and the potential adverse consequences that can
result from any breakthrough seizure leads many neurologists to prescribe
branded drugs in lieu of generic substitutes. Despite the introduction of
generic competition in June 2001, Mysoline 50 milligram tablets have retained
31% of the 50 milligram primidone market as of the end of the second quarter of
2003. In comparison, generic versions of the 250 milligram primidone tablet were
introduced in 1981 and Mysoline 250 milligram tablets have retained 16% of the
250 milligram primidone market as of the end of the second quarter of 2003.
However, as a result of the generic competition, we have experienced declining
prescription trends for Mysoline.
Product Development
Our strategic objectives include building a product pipeline that will leverage
our organization by acquiring late-stage development product candidates that,
subject to regulatory approval, can be marketed to our targeted physician
audiences. We currently do not have rights to any development product
candidates. We target product candidates that are in Phase II clinical studies
up through the filing of new drug applications at the FDA. Our management team
has significant experience in managing neurology product candidates through the
development process and successful FDA approval. We have developed valuable
relationships with third-party consultants and contract research organizations
that we intend to utilize to support our advancement of late-stage development
product candidates through the development and approval process. The future
acquisition and development of product candidates should increase significantly
our development expenses and reduce our operating results until such product
candidates are approved, marketed and generate revenue, which is not assumed. If
product candidates that we may acquire do not receive FDA approval, or even
after receiving FDA approval, do not develop substantial sales, we may not
recover our investment in these product candidates.
Currently, we are pursuing opportunities to develop product enhancements for
both Diastat and Migranal that, subject to regulatory approval, we believe will
provide additional patient, physician and distribution channel benefits. For
competitive reasons, we do not disclose the specifics about our product
enhancement programs. However, potential enhancements could include new delivery
systems, new formulations and new dosage strengths. We also intend to evaluate
opportunities to conduct targeted post-approval clinical studies for our
products. We believe these types of product enhancements can offer important
patient benefits and attractive opportunities to increase the use of our
products. The development of product enhancements typically is less costly, less
risky and requires less time than most other development efforts. We rely on
third parties to assist us in our development of product enhancements.
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Sales and Marketing
During 2002, the 14,800 neurologists and pediatric neurologists in the United
States collectively wrote prescriptions for $1.5 billion of the products used to
treat epileptic seizures and $354 million of the products used to treat
migraine. Our field sales organization promotes our products to 6,900 of the
highest prescribing physicians in this group. These 6,900 high-prescribing
neurologists collectively wrote 93% of the prescriptions for migraine and
epilepsy products among all 14,800 neurologists and pediatric neurologists in
2002. This concentration of high volume prescribers enables us to promote
effectively our products with a small, dedicated sales and marketing
organization.
Our field sales professionals are positioned in major metropolitan areas across
the United States. Our two regional directors and ten area business managers
have an average of ten years pharmaceutical experience, which includes five
years pharmaceutical management experience. Our 84 sales representatives have an
average of seven years sales experience, which includes four years
pharmaceutical sales experience. Each member of our sales team undergoes a
rigorous training program focused on our product offerings, disease background,
competitive products and our sales techniques. Our program includes significant
field-based learning to provide a comprehensive understanding and perspective as
to the CNS market and the needs of both physicians and patients.
We have created an incentive bonus program for our sales force based on
performance, with no limit on the total bonuses that can be earned. We focus on
cultivating a relationship of trust and confidence with our targeted physician
audience. In addition, we use a variety of marketing programs to promote our
products, including promotional materials, industry publications and educational
conferences and seminars. We continuously educate our representatives, as well
as physicians and medical personnel, on the clinical merits of our products.
Material Agreements
Product Acquisition Agreements:
Diastat and Mysoline
We acquired rights to our epilepsy products pursuant to agreements that we
entered into with Elan in March and April 2001. Under these agreements, we
acquired exclusive worldwide rights to Diastat and exclusive rights to Mysoline
in the United States. We also acquired equipment that is used by our third-party
manufacturer in the manufacture of Diastat. The equipment included molds that
are unique to the manufacture of Diastat and other items that are used generally
in the manufacture of pharmaceutical products. The purchase price for these
assets included the assumption of third-party agreements and royalty obligations
of Elan pertaining to the products. The purchase price for these assets
consisted of a net cost of $148.7 million of which we borrowed $99.0 million
from Elan and included a $1.0 million obligation we recorded for returns,
chargebacks and rebates related to sales of the products prior to our
acquisition. The $99.0 million that we borrowed from Elan was repaid in full in
March 2003 with a cash payment of $61.5 million.
The agreements with Elan contain customary representation, warranty, indemnity
and confidentiality provisions. The third-party agreements that we assumed
relate primarily to the manufacture of Diastat and Mysoline and are discussed in
more detail under "-Manufacturing." The third-party royalty obligations that we
assumed range in amounts from 5% to 10% of net sales on these products. We also
acquired existing inventory of both Diastat and Mysoline from Elan for an
additional $5.2 million.
Migranal and D.H.E. 45
We acquired rights to our migraine products pursuant to agreements that we
entered into with Novartis in June 2002. Under these agreements, we acquired
exclusive rights to Migranal and D.H.E. 45 in the United States. The net cost
for these assets was $49.0 million. Included in the net cost is a $1.1 million
obligation we recorded
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for returns, chargebacks and rebates related to sales of the products prior to
our acquisition. The agreements with Novartis contain customary representation,
warranty, indemnity and confidentiality provisions. In connection with the
acquisition of these products, we entered into a supply agreement with Novartis
to manufacture Migranal and D.H.E. 45. The supply agreement is discussed in more
detail under "-Manufacturing." We also acquired existing inventory of both
Migranal and D.H.E. 45 from Novartis for an additional $1.8 million.
Debt and Security Agreements:
Elan Agreements
In connection with the purchase of Diastat and Mysoline from Elan, we entered
into a loan agreement under which Elan provided us with $99.0 million in product
financing. Under the loan agreement, Elan also agreed to provide us with a $10.0
million credit line, which we borrowed in full in June 2002. The $99.0 million
in product financing owed to Elan and the $10.0 million in credit line
borrowings were repaid in full in March 2003 through the payment of $71.5
million. We recorded a gain of $37.4 million on the retirement of the product
financing.
Under the terms of the product acquisition agreements, Elan was responsible for
the payment and processing of returns, chargebacks and rebates on Diastat and
Mysoline sold by Elan prior to our acquisition of the products up to
contractually specified amounts and time periods. As of December 31, 2002, the
contractually specified time periods had ended. In addition, Elan continues to
process and pay rebates on our sales of Diastat and Mysoline inventories we
acquired from Elan in connection with the acquisition of the products. As of
June 30, 2003, we have recorded an estimated liability to Elan of $9.9 million
related to these contractual obligations. On August 5, 2003, we paid Elan $9.6
million in satisfaction of the $9.9 million of contractual obligations accrued
as of June 30, 2003. Payment of agreed upon liabilities subsequent to June 30,
2003 are due to Elan 30 days after receipt of an invoice from Elan.
In June 2001, we entered into an agreement with Elan whereby Elan agreed to make
payments to us through December 31, 2010 based on the net sales of Elan's
product Zanaflex. In exchange, we and Elan amended the original product
acquisition agreements to provide for payments from us to Elan through
December 31, 2015 based on the net sales of Mysoline. This product financing had
an imputed interest rate of approximately 7% based on estimates of the total net
payments over the term of the financing. In March 2003, these agreements were
mutually terminated with no future obligations remaining on either party. We
recorded a gain on termination of $246,000.
Senior Debt Agreement
In March 2003, we raised proceeds of $62.0 million through the issuance of
senior secured debt to Regiment. We are obligated to make monthly payments of
interest only at prime (with a minimum of 6.5%) plus 4.5% on the outstanding
balance of this loan through March 31, 2004. This resulted in a contractual
interest rate of 11% through June 30, 2003. Quarterly principal payments of $2.0
million are due June 30, 2004 through December 31, 2007 with a final balloon
payment of $32.0 million due on March 31, 2008.
To secure our obligations under the loan agreement, we entered into a security
agreement pursuant to which we granted a security interest in all of our assets
to Regiment. Under the loan and security agreements, Regiment also is protected
by various financial and operating covenants and other rights that, if breached
by us, even in the absence of a payment default, would entitle Regiment to
foreclose on its security interest without payment or refund to us. Our
covenants under the loan and security agreements include not taking, without
Regiment's consent, any of the following actions:
engaging in a line of business outside of the development,
marketing, manufacturing, distribution and selling of
pharmaceutical products affecting the CNS;
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selling, leasing or disposing of all or any part of our assets or business;
acquiring all or substantially all of the assets of others;
merging with or consolidating into other parties; or
making certain distributions to our stockholders.
In addition, except for specific exceptions set forth in the loan and security
agreements, including an exception allowing us to incur subordinated debt in
connection with permitted acquisitions, we cannot have debt outstanding to
anyone other than to Regiment. We will also be in default if we fail to cure a
breach of our representations, warranties and covenants under the agreements
within any applicable cure period. If we fail to cure any breach, Regiment may
exercise its rights and remedies under the agreements, including accelerating
the due date of all our obligations and foreclosing on the collateral, without
payment or refund.