Confidential Materials omitted and
filed separately with the
Securities and Exchange Commission.
Asterisks denote omissions.
THIS AGREEMENT is made on the 20TH day of____December _____ 2001
(Effective Date).
BETWEEN
(1) Minnesota Mining and Manufacture Company ("3M") and 3M Innovative
Properties Company ("3M IPC"), both having a principal office at 3M
Center, Building 275-3E-10, St. Paul, MN 55144-1000, USA).
(2) Sepracor Inc. ("SEPRACOR"), having a principal office at 111 Locke Drive,
Marlborough, MA 01752.
WHEREAS
A. 3M has experience and technology in the formulation, scale-up, and
manufacture of pharmaceutical products in aerosols for inhalation therapy.
B. SEPRACOR wishes 3M to scale-up an aerosol product that SEPRACOR has
developed containing non-CFC propellants and a SEPRACOR proprietary
compound known as levalbuterol tartrate which SEPRACOR wishes to market
for inhalation therapy.
C. If the scale-up is successful and SEPRACOR decides to market the resulting
aerosol product or aerosol products, SEPRACOR shall purchase its
requirements of the product or products from 3M subject to the terms and
conditions of this Agreement and a Supply Agreement (as defined below), or
if 3M is unable to, or chooses not to, supply, 3M shall provide SEPRACOR
with reasonable assistance and licenses as set out in this Agreement to
manufacture or have manufactured the product.
D. 3M is willing to conduct the scale-up subject to the terms of this
Agreement, with the understanding that there is no guarantee that the
program will be successful or that 3M will ultimately supply marketable
product.
1. INTERPRETATION AND DEFINITIONS
1.1 The terms defined in this Article 1 shall for all purposes in this
Agreement have the meanings specified in this Article 1.
1.1:1 The headings in this Agreement shall not affect its interpretation.
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1.1:2 Throughout this Agreement, whenever required by the context, the
singular includes the plural and vice versa and any gender includes any
other gender.
1.1:3 The recitals and schedules to this Agreement constitute an integral part
of this Agreement. In the event of conflict or inconsistency between any
of the terms and conditions of this Agreement, the conflict or
inconsistency shall be resolved according to the following order of
priority: the clauses of the Agreement, the schedules, the recitals.
1.2 "Affiliate" shall mean:
1.2:1 any individual who or Entity ("Entity" shall mean any
corporation, firm, partnership, proprietorship, other form of business
organization) that, in whatever country organized or resident, directly
or indirectly through one or more intermediaries, is controlled by, or
is under common control with, or controls, a Party; or
1.2:2 any Entity in which any Party or any individual or Entity recited
in the preceding Section (1) directly or indirectly through one or more
intermediaries collectively has at least a forty percent (40%)
ownership or voting rights interest (whether through stock ownership,
stock power, voting proxy, or otherwise) or has the maximum ownership
interest it is permitted to have in the Entity in the country where
such Entity exists.
1.3 "Product" means a press-and-breathe inhaler containing a pressurized
aerosol canister with a metered dose valve filled with a formulation of
the Compound (as defined below) that SEPRACOR has selected having the
formulation, and meeting the Specifications, set forth in Schedule 1.12.
The term "Licensed Product" means Product containing the Compound
levalbuterol tartrate. "Tartrate" shall mean any tartaric acid salt,
[**].
1.4 "Authority" means a governmental agency, in a country or territory in
which SEPRACOR proposes to sell Product, responsible for granting licences
and/or approvals permitting the sale of the Product, in such country or
territory.
1.5 "Compound" means the compound known as levalbuterol, including any salt,
ester, solvate, clathrate, or polymorph thereof.
1.6 "SEPRACOR Components" means all components and ingredients, other than
Compound, supplied by or on behalf of SEPRACOR for manufacturing Licensed
Product.
1.7 "Scale-up Program" means the development work conducted pursuant to the
protocol and the work schedule indicating milestones and activities
annexed hereto as Schedule 1.7 as amended in writing from time to time in
accordance with the terms of this Agreement.
1.8 "3M Confidential Information" means confidential information disclosed by
3M to SEPRACOR in the course of and pursuant to this Agreement relating to
aerosol
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inhalation, or aerosol compositions, including: the specifications and
chemistry of aerosol formulations of Compound developed by 3M or its
Affiliates; metered dose inhaler devices and their specifications; the
methods and techniques used by 3M to manufacture aerosol inhalers and
metered dose devices; and confidential information directly or
indirectly provided by 3M to assist SEPRACOR to obtain a licence or
approval permitting the sale of Licensed Product, including clinical
results for metered dose devices
1.9 "SEPRACOR Confidential Information" means confidential information
disclosed by SEPRACOR to 3M in the course of and pursuant to this
Agreement relating to Compound, aerosol inhalation, or aerosol
compositions, including: the specifications and chemistry of formulations
of the Compound developed by SEPRACOR or its Affiliates; metered dose
inhaler devices and their specifications for delivery of Compound;
SEPRACOR's clinical and non-clinical development plans; SEPRACOR's
clinical data; and forecasts of requirements of Licensed Product.
1.10 "Parties" mean 3M, 3M IPC and SEPRACOR and their permitted assigns, and "a
Party" means 3M, 3M IPC or SEPRACOR and their permitted assigns.
1.11 "Supply Agreement" means the supply agreement referred to in Article 8
below.
1.12 "Specifications" means those specifications for Licensed Product,
Compound, or SEPRACOR Components as established in writing by SEPRACOR,
and subject to approval by 3M, which approval shall not unreasonably be
withheld or delayed, and as may be amended from time to time in writing by
SEPRACOR, subject to approval by 3M, which approval shall not unreasonably
be withheld or delayed. Initial Specifications, once approved by both
parties, will be set forth in Schedule 1.12.
1.13 "Test Methods" means those methods used for testing and releasing
Compound, SEPRACOR Components, or Licensed Product, agreed upon in writing
by the Parties and as amended from time to time, subject to approval by
the Parties, which approval shall not unreasonably be withheld or delayed,
provided that no Party shall have the obligation to provide to the other
Party direct access to Test Methods that are provided by way of a DMF.
1.14 "3M Patent Rights" means all patents and patent applications that are
owned or controlled by 3M or an Affiliate thereof and that cover
manufacture, use, or sale of Licensed Product, including but not limited
to certain of those patents claiming benefit of priority to, or having a
substantially identical disclosure as, Great Britain application
GB8828477, filed December 6, 1988, U.S. application 442,119, filed
November 28, 1989, U.S. application 92,001, filed July 15, 1993, and all
applicable continuations, continuations-inpart, divisionals, extensions,
supplemental protection certificates, utility models, reissues, and
reexaminations thereof.
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1.15 "3M Know-How" means 3M Confidential Information and any other information
or data of 3M or 3M IPC useful in developing, optimizing, manufacturing,
or gaining regulatory approval of Licensed Product, including any
toxicological data, provided by 3M.
1.16 "Net Sales Price" shall mean the price received by SEPRACOR, their
Affiliates, or permitted sublicensees for Licensed Product from
wholesalers, distributors, managed healthcare organizations, or similar
entities at the same level of distribution in arms length transactions
involving cash as the sole consideration, which shall not include
transfers within or between SEPRACOR, their Affiliates or sublicensees,
after deduction of freight and insurance, rebates and chargebacks granted
to managed health care organizations or to federal, state and local
governments, their agencies, and purchasers and reimbursers or to trade
customers, including but not limited to, wholesalers and chain and
pharmacy buying groups, other trade and quantity discounts actually given,
sales or value added taxes, and credits and allowances for returns.
SEPRACOR's customers shall include purchasers in the chain of commerce who
enter into agreements with SEPRACOR as to price, even though legal title
to Licensed Product does not pass directly from SEPRACOR to such customer,
and even though payment for Licensed Product is not made by such customer
directly to SEPRACOR. Licensed Product sold in transactions involving
consideration other than or in addition to cash shall be deemed to have
been sold at the average price charged by SEPRACOR in an arm's length cash
transaction to the applicable class of trade in the relevant annual period
(or, if all transactions in the applicable class of trade involve
consideration other than or in addition to cash, the average price charged
by SEPRACOR in an arm's length cash transaction in the relevant annual
period irrespective of class of trade). The preceding sentence shall not
apply to Licensed Product samples provided free of charge to physicians in
the course of promoting Licensed Product, nor shall it apply to Licensed
Product provided free of charge as part of a contract involving Licensed
Product only.
2. TERM
2.1 This Agreement shall commence on the effective date set forth above and
(subject to earlier termination according to the terms set out in this
Agreement) shall expire on the first to occur of the date (i) Licensed
Product is approved for sale in the U.S. or Europe, or (ii) five years
from the Effective Date. However, this agreement may be extended upon
written agreement of the parties.
3. CONDUCT OF THE SCALE-UP PROGRAM
3.1 During the Scale-up Program, each Party shall be licensed free-of-charge
under those rights of the other Party as are required for the sole purpose
of conducting the Scale-up Program of Licensed Product. Further, for the
avoidance of doubt and notwithstanding anything in this Agreement to the
contrary, SEPRACOR shall have no right or license to 3M Patent Rights or
3M Know-How, including the right to reference regulatory data, and
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3M shall have no obligation to develop, supply, license, or provide
access to 3M Know-How, including any regulatory data, for any Product
other than Licensed Product
3.2 3M and SEPRACOR shall each identify the contact person at their respective
offices to serve as the recipient of communications concerning the
Scale-up Program.
3.3 Each Party shall use good faith reasonable efforts to perform those duties
assigned to it in the Scale-up Program.
3.4 The Parties may by written agreement amend the Scale-up Program. Consent
to amend the Scale-up Program shall not be unreasonably withheld or
delayed, provided that an appropriate adjustment shall be made in the
timetable, man-hours or other matters affected thereby to allow for any
variation in the time required to complete the Scale-up Program as a
consequence of an amendment.
3.5 3M shall notify SEPRACOR without undue delay if it becomes aware that the
time estimated for a task or tasks set out in the Scale-up Program will be
insufficient to perform such task or tasks. If the new time estimate
exceeds the original estimate by more than 20%, the Parties shall discuss
how to minimize the additional time.
4. MEETINGS AND REPORTS RELATING TO THE SCALE-UP PROGRAM
4.1 A Joint Coordinating Committee (JCC), with a minimum of 2 persons each
from 3M and SEPRACOR, shall coordinate and monitor conduct of the
Development Program. JCC shall meet quarterly. 3M shall provide quarterly
reports to SEPRACOR on the progress of the Scale-up Program and shall
promptly notify SEPRACOR of any event that requires a decision by SEPRACOR
or will have a serious effect on the progress of the Scale-up Program.
4.2 3M recognizes that SEPRACOR may elect to make changes to the Scale-up
Program or Product definition during the course of development and scale
up. If SEPRACOR elects to make such changes, 3M will upon request propose
a revised Scale-up Program and budget.
5. SUPPLY OF COMPOUND AND COMPONENTS
5.1 SEPRACOR shall supply 3M (i) [**] with sufficient quantities of the
Compound and SEPRACOR Components as determined by the Scale-up Program
to enable 3M to conduct the Scale-up Program and (ii) a certificate of
analysis for the Compound and SEPRACOR Components. Any Compound and
SEPRACOR Components unused by 3M at the termination of the Scale-up
Program shall be returned upon request to SEPRACOR.
5.2 SEPRACOR shall promptly provide 3M with all information in or coming into
its possession concerning the Compound that 3M will reasonably require for
the safe handling, storage, testing, use and transport of the Compound.
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6. CLINICAL STUDIES AND TOXICOLOGY STUDIES
6.1 SEPRACOR shall [**] be responsible for any clinical studies and,
except as provided in Sections 6.2 and 6.3 below, any toxicology
studies and all contact with any Authority concerning Licensed Product,
provided that 3M shall have the right to require SEPRACOR to use a right
of reference or analogous means to meet any Authority's disclosure
requirements concerning 3M Confidential Information to the extent
permitted by the Authorities. 3M shall, if requested, consult with and
provide reasonable assistance to SEPRACOR in clinical trials as
appropriate, provided that 3M's time for such consulting and assistance
shall be paid by SEPRACOR and SEPRACOR shall ultimately bear all
responsibility for any use of information provided by 3M (including use in
regulatory filings and any third party liability for all such clinical
trials).
6.2 3M will establish a Drug Master File (DMF) with appropriate information
for the CMC section of the regulatory submissions for Licensed Product,
and will provide a letter of authorization to FDA or health authorities to
access the DMF for regulatory submissions for Licensed Product. In
submissions where a right of reference is demonstrated to be inadequate,
3M shall prepare a proprietary dossier including information which is
necessary or required by law to obtain regulatory approval of Licensed
Product. 3M shall respond promptly to all inquiries by any Authority
concerning the proprietary dossier or the DMF and share the general
substance of the inquiry and the response with SEPRACOR. The 3M
proprietary dossier will be provided to (a) the applicable regulatory
agency or (b) SEPRACOR, at 3M's election. Provided, however, that neither
the forgoing, the information provided pursuant to Section 6.3 nor
anything else in this Agreement shall be construed as a warranty by 3M
that any DMF or other regulatory dossier will be approved by any
Authority.
6.3 3M agrees to provide SEPRACOR as of the Effective Date, with:
(a) a right of reference to (i) data held by the International
Pharmaceutical Aerosol Consortium for Toxicology Testing
of}IFA-134a ("IPACT I") consistent with 3M's obligations to IPACT
I, and (ii) any additional 3M data for which 3M has the right to
grant a right of reference relating specifically to [**]
that has previously been required by FDA in connection with
approval of an [**]; and
(b) a right of reference that would authorize FDA to access all
studies conducted by 3M or contracted by 3M in [**],
including but not limited to toxicological and chronic human
safety data and all pertinent cross-referenced information, (as
approved on August 15, 1996) expressly for the purpose of review
to substantiate the pre-clinical and clinical safety of albuterol
in a formulation containing [**]. 3M agrees to provide a right
to reference such information only for purposes of facilitating
regulatory approval of Licensed Product and SEPRACOR shall not
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use or disclose such information for any other purpose, including
clinical comparisons between levalbuterol and albuterol apart
from those comparisons that facilitate evaluation of the safety
of levalbuterol in a formulation containing [**].
3M shall respond promptly to all inquiries by any Authority concerning
the information referenced by SEPRACOR pursuant to Sections 6.3 (a) and
6.3(b), and shall share the general substance of the inquiry and the
response with SEPRACOR. For the avoidance of doubt, the Parties
expressly agree that 3M does not grant to SEPRACOR, and this Agreement
creates no obligation on 3M to grant to SEPRACOR, any right of
reference to safety data concerning the drug substance albuterol
(including salts such as the sulfate) alone or to data not generated by
or on behalf of 3M.
6.4 If requested by SEPRACOR and in accordance with the Scale-up Program, 3M
shall manufacture and supply SEPRACOR with Licensed Product, including
Licensed Product for use in clinical studies or toxicology studies, at
prices calculated in the manner set out in Schedule 6.4 using reasonable
endeavors to supply SEPRACOR in time to meet its needs. SEPRACOR shall
pay 3M's invoices for such Licensed Products within [**] days of the
date of 3M's invoice. Licensed Product that is to be used in clinical
trials shall be manufactured and tested under cGMPs and the applicable
Investigational New Drug Application. 3M will perform release testing of
all batches to agreed upon Specifications. SEPRACOR shall have the right
within 45 days to test batches on an audit basis prior to accepting the
batch, however SEPRACOR shall have no right to delay payment. SEPRACOR
will have a right to credit for Licensed Product, only in the event
Licensed Product is found not to meet the warranty set forth in Section
10.6.
6.5 3M shall allow SEPRACOR to perform a cGMP compliance audit promptly after
signing of this Agreement on a date as agreed to by the parties.
6.6 3M and SEPRACOR shall discuss and agree to quality assurance and quality
control responsibilities, to be set forth as Schedule 6.6 and signed by
the Parties, including a batch release and record review process utilizing
certificates of compliance and analysis and other reporting documents as
appropriate between 3M and SEPRACOR. 3M shall, unless otherwise agreed, be
responsible for testing raw materials and components, other than Compound
and SEPRACOR Components, in accordance with 3M written specifications.
SEPRACOR shall provide to 3M all methods currently in use at a time during
development to be agreed upon by the parties, and 3M shall be responsible
for development of any methods used for process measurements and any
additional raw material test methods.
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6.7 If either party performs stability storage and stability testing of
supplies, that Party will provide stability reports to the other Party
corresponding to industry accepted pull points. Reports to include
individual data points if deemed necessary by the receiving Party.
6.8 3M acknowledges that SEPRACOR has filed an IND under which Licensed
Product will be tested and developed, and that SEPRACOR will be required
to make regulatory commitments to FDA with respect to the development of
Licensed Product. SEPRACOR shall use good faith reasonable efforts to
inform 3M of such commitments and to consult 3M in connection with any
such commitments that raise CMC issues and shall reimburse 3M for
additional costs reasonably incurred as a result of such commitments, and
3M shall use good faith reasonable efforts in order to operate in a manner
that facilitates compliance with such commitments.
6.9 For the avoidance of doubt, the parties expressly agree that nothing in
this Agreement shall be construed to limit SEPRACOR's right to conduct
studies, including but not limited to preclinical and clinical studies,
involving comparisons between albuterol and levalbuterol, or SEPRACOR's
right to use or disclose the results of such studies.
7. PAYMENT FOR ACCESS TO 3M CLINICAL INFORMATION AND THE SCALE-UP PROGRAM
7.1 In consideration for the rights of reference granted by 3M to SEPRACOR
pursuant to Section 6.3 hereof, within [**] days of the Effective
Date SEPRACOR shall pay to 3M a data access fee of [**] Dollars [**].
7.2 SEPRACOR shall pay 3M a service fee of [**] dollars $[**] per hour spent
on the Scale-up Program, including time spent in writing reports,
attending meetings, and managing the project; provided, however, that for
the first [**] hours of work invoiced by 3M in 2002, which is the minimum
amount of work SEPRACOR shall authorize 3M to conduct in 2002, under this
Agreement in connection with the Scale-up Program, the service fee shall
be [**] dollars $[**] per hour. Any other provision of this Agreement
notwithstanding, SEPRACOR shall not have the right to terminate this
Agreement, except for cause under section 12.1, until after the first
[**] hours of work for 2002 are invoiced by 3M and paid by SEPRACOR under
this Agreement in connection with the Scale-up Program. Units
manufactured at 3M's production site will be charged as set forth in
Schedule 6.4 based on theoretical batch size. Invoices for hourly work
shall be submitted by 3M monthly and payment shall be made to 3M by
SEPRACOR within [**] days of the date of 3M's invoice.
7.3 In addition to the payments in Section 7.2 above, SEPRACOR shall reimburse
3M the reasonable cost of travel, subsistence and accommodation for travel
in connection with the Scale-up Program at SEPRACOR's request or with
SEPRACOR's written approval, such reimbursement to be consistent with 3M's
internal travel policy.
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7.4 The hourly rate of [**] dollars $[**] shall remain unchanged until the
31st December 2001, after which it may be increased [**] period to take
into account reasonable increases in 3M's costs since the last increase
in the hourly rate, provided that such adjustments shall not exceed the
annual increase in the PPI (producer price index) from the prior calendar
year.
8. SUPPLY AGREEMENT
8.1 3M may exercise any right or fulfill any obligation in this Article 8
itself or may procure an Affiliate to exercise such right or fulfill such
obligation.
8.2 If SEPRACOR decides to market Licensed Product in any country or countries
of SEPRACOR's choice, no later than the initiation of Phase III clinical
studies SEPRACOR shall give prompt written notice to 3M following which
the Parties shall, negotiate in good faith an exclusive Manufacture and
Supply Agreement consistent with all relevant licensing and commercial
supply terms contained in this Agreement and including reasonable annual
minimum purchase requirements to be agreed upon no later than the NDA
filing.
8.3 The Parties agree to negotiate in good faith a volume based supply price,
to include minimums, for Licensed Product worldwide. The supply price of
Licensed Product to SEPR.ACOR shall be a combination of unit price and
royalty. Unit price of product will be no greater than $[**] per unit for
the first [**] million units annually, and $[**] per unit for those units
in excess of [**] million units annually. The royalty for the license
granted under Section 9.3 shall be [**] percent ([**]%) of SEPRACOR's Net
Sales Price (such royalty to be [**] when and in such countries where
there are no issued or granted 3M Patent Rights). A supply price for
sample Licensed Product will be negotiated by the Parties in the Supply
Agreement. The following factors have been assumed for purposes of
determining the above supply price:
- [**] actuation product
- SEPRACOR provides Levalbuterol tartrate at no cost
- 3M purchase actuator, aluminum can, valve, propellant
and other formulation components and finished packaging
material
- 3M's [**] manufacturing process is typical of other
3M manufactured products.
- 3M's testing of raw materials and finished product is
typical of other 3M manufactured products.
The above unit prices may be adjusted at any time prior to launch and
thereafter annually and proportionally for any increase in 3M's Full
Factory Cost (defined as 3M's costs for overhead, labor, raw material,
and/or component costs directly allocable to the manufacture, labeling
and/or packaging of Licensed Product and the cost of services supplied to
3M by third parties which are directly allocable to the manufacture,
labeling
-9-
and/or packaging of Licensed Product) including such amount as is
necessary to allow 3M to maintain its factory cost ratio of Licensed
Product. Such increase shall normally be no greater than PPI +1% from the
prior calendar year. In the event of an extraordinary increase in price
due to such factors as a shortage of raw material or change in product
specifications or manufacturing mandated by regulatory authorities, 3M may
increase the supply price for Licensed Product at the time it incurs such
increase. In addition, 3M reserves the right prior to commencement of the
Manufacture and Supply Agreement to increase the maximum price quoted
herein for any change in the assumptions stated above or any increase in
the cost of manufacturing Licensed Product due to an increase in the cost
of acquiring SEPRACOR Components above the cost on the Effective date
including any additional cost necessary to maintain 3M's factory cost
ratio.
8.4 3M shall exclusively supply, using reasonable commercial efforts to do so,
Licensed Product to SEPRACOR, Affiliates, and permitted sublicensees only
and 3M shall not supply Product (not limited to Licensed Product) to any
third party. Except as provided in Section 8.5 below, 3M shall have the
exclusive right and license to supply SEPRACOR, its Affiliates and
permitted sublicensee' s requirements of Licensed Product, and SEPRACOR,
Affiliates, and permitted sublicensees shall not purchase Product (not
limited to Licensed Product) other than from 3M, during the term of this
Agreement.
8.5 Anything else in this Agreement to the contrary notwithstanding, SEPRACOR
shall have the limited contractual right to procure Licensed Product for
use in clinical trials only from a third party for such time as 3M is
unable to provide SEPRACOR with such supply, provided, however, that (i)
SEPRACOR shall diligently pursue obtaining regulatory approval for
Licensed Product manufactured by 3M, (ii) neither SEPRACOR nor the third
party supplier shall have any right to use any 3M Know-How in the
manufacture of such Licensed Product, and (iii) from and after the time
that 3M is able to supply Licensed Product pursuant to this Agreement or
the Supply Agreement, 3M shall have the exclusive right and license to
supply SEPRACOR, its Affiliates, and permitted sublicensee's requirements
of Licensed Product during the term of this Agreement and any future
Supply Agreement.
9. OWNERSHIP OF INTELLECTUAL PROPERTY RIGHTS; LICENSES
9.1 Ownership of all right, title, and interest in intellectual property,
including inventions, know-how, trade secrets and copyright, including but
not limited to patent applications and patents, arising out of the
Scale-up Program ("Rights") shall be allocated as follows:
9.1:1 3M 1PC (or an Affiliate nominated by 3M IPC) shall own all
Rights conceived solely by 3M and/or 3M Affiliate employees;
9.1:2 SEPRACOR shall own all Rights conceived solely by SEPRACOR's
and/or SEPRACOR Affiliate employees;
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9.1:3 Rights jointly conceived by 3M (or a 3M Affiliate) and
SEPRACOR (or a SEPRACOR Affiliate) shall be owned jointly by
3M IPC (or an Affiliate nominated by 3M IPC) and SEPRACOR (or
an Affiliate nominated by SEPRACOR). Each of the Parties shall
have a royalty-free right to use the Rights which are jointly
owned without the consent of and without accounting to the
other Party independently of the other Party (with the right
to sub-license) except as otherwise expressly provided herein.
3M and 3M IPC shall share equally with SEPRACOR in the costs,
fees and expenses of preparing, filing and prosecuting any
patent application claiming jointly owned Rights and of
maintaining and defending the Rights, provided that if either
Party fails to pay its share, it shall assign its entire
interest to the other Party. Unless otherwise agreed, patent
applications shall be prepared and prosecuted by 3M IPC or, at
3M IPC's election, an Affiliate of 3M IPC or independent
counsel mutually acceptable to 3M IPC and SEPRACOR.
9.2 The Parties shall upon request cooperate with one another so far as
necessary in connection with the filing of applications for patents for
their respective inventions.
9.3 3M IPC hereby grants SEPRACOR a worldwide, royalty-bearing, non-exclusive
license under the 3M Patent Rights and 3M Know-How to use, sell, offer for
sale, and import Licensed Product manufactured by or for 3M under this
Agreement or a subsequent Supply Agreement. SEPRACOR shall have the right
to submit for listing on the FDA "Orange Book" patents under 3M Patent
Rights that cover Licensed Product, provided that 3M and 3M IPC shall have
no obligation to enforce any such patents and may grant licenses under the
3M Patent Rights at 3M/3M IPC's sole discretion
9.4 If this Agreement is terminated by SEPRACOR pursuant to Section 12.2
below, SEPRACOR will cease use of any 3M Confidential Information which
has been disclosed to it by 3M and which is subject to the non-disclosure
provisions of Article 11 below, and the license to 3M Know-How and 3M
Patent Rights shall terminate.
9.5 If this Agreement is terminated by SEPRACOR pursuant to Section 12.1 or by
3M pursuant to Section 12.3 below, the rights and obligations set forth in
Section 6.3 shall remain in effect, and 3M and SEPRACOR shall cooperate
diligently in the transfer, at SEPRACOR's expense, of 3M Know-How to
SEPRACOR or an alternative manufacturer selected by SEPRACOR (subject to
the last sentence of this Section 9.5). 3M shall continue to develop and
supply Licensed Product to SEPRACOR under the terms of this Agreement or
the Supply Agreement (as applicable) for up to 24 months after notice of
termination and 3M IPC shall grant SEPRACOR such world-wide, non-exclusive
licenses under 3M Patents and 3M Know-How to make, have made for it, use
and sell Licensed Product at a royalty rate of 4% of Net Sales Price (such
royalty to be reduced by one-half when and in such countries where there
are no issued or granted 3M Patent Rights), PROVIDED, HOWEVER, that
SEPRACOR shall indemnify 3M and 3M 1PC for any liability arising out of
3M's continued activity after the date of notice of termination or arising
out of use, manufacture, sale, promotion or transfer of Licensed Product
by SEPRACOR or any third party working on behalf of SEPRACOR, from the
date 3M provided written notice of termination. The disclosure of 3M
Know-how to SEPRACOR or its
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third party manufacturer shall be subject to undertakings that protect the
3M Know-How from disclosure to others or use by SEPRACOR or its third
party manufacturer beyond the scope of the license, including but not
limited to use with products other than Licensed Product. 3M agrees to
provide 3M employees for consultation in connection with the transfer of
3M Know-How to be provided hereunder for a reasonable period and at a
reasonable rate. 3M shall have the right to deny disclosure of 3M
Confidential Information to a third party manufacturer for reasons
relating to the ability of the third party to manufacture Licensed Product
according to the then prevailing product standards or the lack of
assurance the that the undertakings relating to protection and restricted
use of 3M's Confidential Information and 3M's intellectual property rights
will be complied with, provided that such denial would not be unreasonable
in the reasonable judgment of a pharmaceutical manufacturer in the
position of 3M.
10. WARRANTIES, DISCLAIMERS, INDEMNIFICATION AND LIMITATION OF LIABILITIES
10.1 SEPRACOR warrants that to the best of its knowledge, through in-house
patent counsel, that as of the effective date of this Agreement, Compound,
SEPRACOR Components, and Licensed Product, and the processes used to make
Compound, SEPRACOR Components, and Licensed Product, except for particular
processes and components used by 3M that are not specified by SEPRACOR,
will not inflinge any third party patent or other intellectual property
rights. 3M warrants that to the best of its knowledge, through in-house
patent counsel, that as of the effective date of this Agreement, its
manufacturing processes, not specified by SEPRACOR or based upon Compound
or SEPRACOR Components used for manufacturing Licensed Product will not
infringe any third party patent or other intellectual property rights
(i.e., there would be no infringement but for some attribute of Compound,
SEPRACOR Component, or an attribute of Licensed Product specified by
SEPRACOR). Each Party will notify the other Party promptly in the event a
Party receives an accusation of infringement pertaining to Licensed
Product.
10.2 Neither of the Parties is the agent of the other nor are the Parties
partners or joint venturers.
10.3 Neither of the Parties warrants that the Scale-up Program will result in a
commercially, technically, or regulatorily successful Product, although
each of the Parties shall use reasonable commercial efforts to develop
such Product.
10.4 Although 3M and SEPRACOR will use their reasonable efforts to conduct the
Scale-up Program, no expenditures by either Party hereunder will be
reimbursed because the development of any products or processes has been
unsuccessful.
10.5 SEPRACOR represents and warrants that it will supply 3M Compound and
SEPRACOR Components meeting the agreed upon written specifications.
-12-
10.6 3M hereby represents and warrants that all Licensed Product at the time of
shipment shall meet the agreed upon written Specifications for Licensed
Product and be manufactured in accordance with the IND or NDA, as
applicable, and cGMPs, provided, however, that 3M shall not be responsible
for Licensed Product that does not meet Specifications as a result of
SEPRACOR' s failure to supply Compound or SEPRACOR Components meeting
specifications.
10.7 SEPRACOR warrants that it will conduct any clinical work relating to
Licensed Product in accordance with all applicable laws.
10.8 EXCEPT AS OTHERWISE EXPLICITLY SET FORTH HEREIN, EACH PARTY EXPRESSLY
DISCLAIMS TO THE OTHER PARTY ANY EXPRESS OR IMPLIED WARRANTY, INCLUDING
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND
NON1NFRINGEMENT, ARISING OUT OF ITS PERFORMANCE OR ATTEMPTED DEVELOPMENT
OF A PRODUCT OR PROCESS PURSUANT TO THIS AGREEMENT.
10.9 3M Indemnification -- 3M shall indemnify SEPRACOR against and hold it
harmless from any and all loss or liability payable to third parties for
any and all judgments, claims, causes of action, suits, proceedings,
losses, damages, demands, fees, expenses, fines, penalties or costs
(including without limitation reasonable attorney's fees, costs and
disbursements) arising from any personal injury or alleged personal injury
to any person made against SEPRACOR or 3M with respect to use of Licensed
Product in clinical trials to the extent that it results from 3M's breach
of the warranty set forth in Section 10.6 or for any claim that the
manufacturing processes or components used by 3M, not specified by
SEPRACOR or based upon Compound or SEPRACOR Components used for
manufacturing Licensed Product are alleged to infringe any third party
patent or other intellectual property rights (i.e., there would be no
infringement but for some attribute of Compound, SEPRACOR Component, or
some attribute of Licensed Product specified by SEPRACOR), provided,
however, 3M shall be liable to the extent and only to the extent such
breach resulted in the harm or injury for which SEPRACOR seeks
indemnification.
10.10 SEPRACOR Indemnification - Except as set forth in Section 10.9, SEPRACOR
shall indemnify and hold 3M harmless from any and all loss or liability
payable to third parties for any and all judgments, claims, causes of
action, suits, proceedings, damages, demands, fees, expenses, fines,
penalties and costs (including without limitation reasonable attorney's
fees, costs and disbursements) arising from any personal injury or alleged
personal injury to any person made against SEPRACOR or 3M which result
from (i) use or clinical study of Licensed Product by or on behalf of
SEPRACOR, (ii) breach of SEPRACOR's warranty in Section 10.5, or a third
party claim that Compound, SEPRACOR Components, Licensed Product, or the
processes used to make Compound, SEPRACOR Components, and Licensed
Product, except for particular processes or components used by 3M that are
not specified by SEPRACOR, infringe any third party patent or other
intellectual property rights.
-13-
10.11 Except as set forth in Section 10.9, SEPRACOR's sole and exclusive remedy
against 3M for failure to supply Licensed Product meeting Specifications
shall be, at SEPRACOR's option, replacement of Licensed Product or a
credit for the amount charged by 3M for such Licensed Product.
10.12 EXCEPT AS SET FORTH IN SECTIONS 10.9 AND 10.10 NEITHER PARTY SHALL UNDER
ANY CIRCUMSTANCES BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR ANY
INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES IN ANY WAY RELATED
TO LICENSED PRODUCT, OR THIS AGREEMENT UNDER ANY THEORY OF LAW, INCLUDING
BUT NOT LIMITED TO, CONTRACT, NEGLIGENCE OR ANY OTHER LEGAL THEORY.
10.13 Any obligations regarding a duty to devote resources and efforts to the
development and scale-up of products are contained in this Agreement.
There is no implied obligation to devote any other level of resources or
effort.
11. CONFIDENTIALITY
11.1 In relation to the 3M, 3M IPC, and SEPRACOR Confidential Information, as
the case may be, disclosed by one Party to the other, each Party agrees:
11.1:1 not to provide or make available any of the other Party's
Confidential Information in any form to any person other than
those of its employees and agents who have a need to know
consistent with the receiving Party's authorized use of such
Confidential Information;
11.1:2 not to use or reproduce any of the other Party's Confidential
Information except for use reasonably necessary for its
performance of this Agreement;
11.1:3 not to publish or disclose any of the other Party's
Confidential Information to third parties other than as
expressly permitted in this Agreement, without disclosing
Party's prior written consent.
11.2 The obligations of confidentiality and non-use in Section 11.1 above shall
not apply to any part of such Confidential Information which:
11.2:1 is disclosed only to Authorities or used only for the purposes
of obtaining or maintaining regulatory approvals from
Authorities concerning Licensed Products supplied by 3M; or
11.2:2 is disclosed to or used by its Affiliates, its licensees and
its Affiliates' licensees in the normal course of their
business solely for the purposes set out in Section 11.2:1
above, in which events recipients of such information shall be
bound by
-14-
obligations of confidentiality no less onerous then those
contained in this Article 11; or
11.2:3 is disclosed to Affiliates of the Parties in order reasonably to
perform this Agreement, in which events recipients of such
information shall be bound by obligations of confidentiality no
less onerous than those contained in this Article 11; or
11.2:4 subject to Section 11.3 below, is in or comes into the public
domain in any way without breach of this Agreement by the
receiving Party; or
11.2:5 subject to Section 11.3 below, the receiving Party can show was in
its possession or known to it by being in its use or being
recorded in its files or computers or other recording media prior
to receipt from the disclosing Party and was not previously
acquired by the receiving Party from the discloser under an
obligation of confidence; or
11.2:6 subject to Section 11.3 below, the receiving Party obtains or has
available from a source other than the disclosing Party without
breach by the receiving Party or such source of any obligation of
confidentiality or non-use towards the disclosing Party; or
11.2:7 is disclosed or used to comply with the disclosure obligations of
the patent laws of any jurisdiction in connection with any patent
application relating to Licensed Products or any component thereof
or
11.2:8 is disclosed by the receiving Party (a) with the prior written
approval of the other Party or (b) without such approval, after a
period often (10) years from the date of this Agreement or five
(5) years from the date of termination of this Agreement, or if
executed, five (5) years from the date of termination of the
Supply Agreement whichever shall be the longer period.
11.3 If the receiving Party contends any one or more of the provisions to which
Sections 11.2:4 to 11.2:6 apply, such Party shall give written notice to
the disclosing Party together with evidence to support such contention
prior to being relieved of the obligations of confidentiality and non-use,
and furnish the disclosing Party with all facts upon which the receiving
Party's contention is based. If the disclosing Party disagrees with the
receiving Party's contention and so notifies the receiving Party within
thirty (30) days of receipt of notification by the receiving Party, the
Parties shall seek to resolve the dispute among themselves within twenty
(20) days of notification of a dispute. If not so resolved, the Parties
shall submit the dispute to binding arbitration by a mutually acceptable
U.S. lawyer with experience in trade secret law of the U.S. The Party
whose contention is denied shall pay the lawyer's fees incurred on
resolving the dispute.
-15-
11.4 Both 3M and SEPRACOR shall protect Confidential Information by using the
same degree of care, but not less than a reasonable degree of care, to
prevent the unauthorized disclosure or use of Confidential Information, as
that Party uses to protect its own confidential information of like
nature.
11.5 At such time as the Scale-up Program is terminated, and unless there is a
Supply Agreement, each Party shall upon request return to the other in a
secure manner all extant recorded information in its possession
constituting the other Party's Confidential Information.
11.6 Notwithstanding the foregoing, the receiving Party shall be entitled to
make any disclosure required by law or by any governmental or other
regulatory authority of the other Party's Confidential Information
provided that it gives the other Party not less than two (2) working days
notice of such disclosure.
11.7 Each Party reserves all rights in its Confidential Information and no
rights or obligations other than those expressly recited herein are
granted or to be implied from this Agreement. In particular, no license is
hereby granted directly or indirectly under any patent, invention,
discovery, copyright or other intellectual property right now or in the
future held, made, obtained or licensable by either Party. Nothing in this
Agreement or its operation shall preclude or in any way impair or restrict
either Party from continuing to engage in its business otherwise than in
breach of the terms of this Agreement.
11.8 Nothing in this Agreement shall be construed as requiring a Party to
disclose Confidential Information or to grant rights under licenses, or to
render any technical assistance, which would violate any confidentiality
undertakings or other obligations, or which would violate any present or
future law or decree of any government or governmental officer or agency.
11.9 The Parties agree not to disclose the terms of this Agreement to third
parties, other than Affiliates except to the extent required by law,
without the prior written approval of the other. It is understood,
however, that the existence of this Agreement between 3M and SEPRACOR
itself is not confidential.
12. TERMINATION
12.1 If one of the Parties:
12.1:1 commits or allows to be committed a material incurable breach of
any of its obligations in this Agreement or a breach capable of
remedy which it shall fail to remedy within ninety (90) days (or
thirty (30) days in the case of default in payment, except in the
event SEPRACOR has defaulted on payment on two or more previous
occasions in which case such required notice shall be 10 days)
after written notice has been given to it by the Party not in
default (specifically referring to this Section) requiring such
remedy; or
-16-
12.1:2 shall pass a regulation for winding-up (otherwise than for the
purpose of a solvent amalgamation or reconstruction where the
resulting entity assumes all of the obligations of that Party) or
a court makes an order to that effect, or ceases to carry on its
business or substantially the whole of its business, or becomes or
is declared insolvent or convenes a meeting of or makes or
proposes to make any arrangement or composition with its creditors
or if a liquidator receiver, administrator, trustee, manager or
similar officer is appointed of any of its assets;
then in any such events the Party not in default nor subject to an action
under Section 12.1:2 above may by written notice terminate this Agreement
at such future date (being no more than six (6) months after the date of
such notice) as it may designate, but without prejudice to any right of
either Party to sue for any antecedent breach of this Agreement.
12.2 SEPRACOR may terminate this Agreement without cause upon thirty (30) days
prior written notice to 3M. All charges and expenses owed to 3M prior to
delivery of SEPRACOR's notice shall become due and payable as well as all
charges and expenses reasonably incurred by 3M in winding down the
Scale-up Program over the ninety (90) day period following receipt of the
notice of termination. Such charges and expenses shall not exceed the cost
estimated for such period by reference to the Scale-up Program.
12.3 3M may terminate this Agreement or a subsequent Manufacturing and Supply
Agreement upon thirty (30) days prior written notice if: (i) it can
reasonably demonstrate to SEPRACOR that Licensed Product cannot be
scaled-up by 3M; (ii) 3M transfers, or makes a business decision to
discontinue, substantially all of its medicinal aerosol manufacturing
business; (iii) Licensed Product develops a clinical profile involving an
unusually high number or frequency of serious adverse clinical events that
threatens to seriously damage 3M's corporate reputation and/or expose 3M
to large potential liability and/or fines; (iv) 3M receives a third party
claim for patent infringement involving Product that threatens to
seriously damage 3M1's corporate reputation and/or expose 3M to large
potential liability and/or fines; or (v) if 3M reasonably believes that
the manufacture, use, sale, or importation of Product will infringe the
valid intellectual property rights of a third party.
13. FORCE MAJEURE
13.1 Neither 3M nor SEPRACOR shall be liable for any delay or for the
consequences of any delay in performing any of its obligations under this
Agreement if such delay is due to any cause whatsoever beyond its
reasonable control, and each shall be entitled to a reasonable extension
of the time for performing such obligations.
14. CONTINTJTNG RESPONSIBILITIES AND WAIVER
14.1 Any termination of this Agreement shall not affect any rights or
liabilities, including without limitation any rights accrued pursuant to
Article 9 above, which expressly or by implication have accrued prior to
the date of termination, and failure by either Party in any
-17-
one or more instances to terminate this Agreement on account of any
default or breach by the other shall not be taken to constitute a
condonation or waiver of the same or of any other default or breach by the
other.
15. NOTICES
15.1 Any notice or other document which may be given by either Party under this
Agreement shall be deemed to have been duly given if left at or sent by
post (whether by letter or, where the Parties agree, by magnetic tape or
other form), facsimile transmission (confirmed by letter sent by post) or
where the Parties expressly agree by electronic mail, in each case
addressed as follows:
3M: Minnesota Mining and Manufacturing Co.
3M Center, Building 275-3E-10
St. Paul, MN 55 144-1000 USA
Attention: General Manager, Drug Delivery Systems
Fax: (651) 737-5265
SEPRACOR: Sepracor Inc.
111 Locke Drive
Marlborough, MA, 01752
Attention: President
Fax: (508) 357-7492
or any other address notified to each other in writing in accordance with
this Section as an address to which notices and other documents may be
sent.
15.2 Any such communication shall be deemed to have been received by the other
Party (if by post) five (5) days after the date of posting and if by
facsimile transmission on the working day following transmission. Any
communication by electronic mail shall be deemed to have been received on
the working day following the day on which the communication is first
stored in the other Party's electronic mailbox.
16. WHOLE AGREEMENT AND VARIATION
16.1 This Agreement shall take affect in substitution for all or any previous
agreements relating to its subject matter, whether formal agreements or
agreements that would be inferred from the Parties' correspondence and/or
oral statements and/or conduct, and all or any such agreements shall be
deemed to have been terminated by mutual consent with effect from the date
upon which this Agreement commences.
16.2 This Agreement embodies the entire understanding of the Parties and there
are no other arrangements or understandings between the Parties relating
to its subject matter. No amendment or modification of this Agreement
shall be valid or binding upon either of the Parties unless made in
writing and signed by an authorized representative.
-18-
17.1 This Agreement and the rights granted in it and obligations undertaken may
not be assigned by either of the Parties without the express written
consent of the other, except:
17.1:1 in the case of 3M on the sale or other transfer of substantially
its entire business in aerosol propelled drugs, or
17.1:2 3M may assign temporarily or permanently this Agreement or any
rights granted or obligations undertaken to any Affiliate. 3M
shall be responsible for the compliance by its Affiliates with the
terms and conditions of this Agreement.
17.1:3 SEPRACOR may assign this Agreement and its rights and obligations
hereunder in connection with the transfer or sale of all or
substantially all of its assets related to pharmaceutical
business, or in the event of its merger or consolidation or change
in control or similar transaction, provided that 3M may terminate
unless the assignee covenants to continue with development and
commercialization of Licensed Product at least the same or greater
level as SEPRACOR immediately prior to the assignment.
18. SEVERANCE
18.1 The provisions of this Agreement shall be deemed to be severable and thus
if any part or parts of this Agreement are rendered void, invalid or
unenforceable, such rendering shall not affect the validity or
enforceability of the remainder unless the part or parts which are so
rendered substantially impair the value of the whole Agreement to either
Party. Subject to this, such part or parts of this Agreement so rendered
shall be renegotiated between the Parties in such a way as to render the
same valid and enforceable, and to achieve (to the extent possible) the
economic, business and other purposes of the lawful provisions.
19. INSURANCE
SEPRACOR shall at its own expense obtain and maintain insurance of a type
and amount as may be necessary to protect its interests and obligations
connected with performance under this Agreement. SEPRACOR shall not do or
omit to do any act, matter or thing which could prejudice or render
voidable any such insurance. SEPRACOR shall, upon request by 3M, provide a
certification evidencing the insurance or any renewal. SEPRACOR shall
notify 3M of any material change in any such insurance arrangements, if
possible, prior to such material change, but in any event, as soon as
possible.
-19-
20. DISPUTE RESOLUTION
20.1 NON-BINDING MEDIATION. Disputes arising between the Parties relating to
the making or performance of this Agreement (including ownership of
intellectual property rights, breach of confidentiality, inventorship,
etc.) shall be resolved in the following order of preference: (i) by good
faith negotiation between executives of 3M and SEPRACOR who have authority
to fully and finally resolve the dispute; (ii) if necessary, by
non-binding mediation at a location acceptable to both Parties using a
neutral mediator having experience with the industry under the Center for
Public Resources Model Procedure for Mediation of Business Disputes (with
the costs therefor shared equally); or (iii) as a last resort only, by
arbitration of inventorship disputes as provided in Section 20.2 of this
Article, or by litigation of any other disputes.
20.2 INVENTORSHIP DISPUTES. If the parties are unable to resolve any dispute
regarding inventorship by negotiation or mediation under Section 20.1 of
this Article, they agree to submit such dispute to binding arbitration
under the Center for Public Resources Rules for Non-Administered
Arbitration of Patent and Trade Secret Disputes. The arbitrator shall be
an independent patent attorney residing in the United States and
registered to practice before the United States Patent and Trademark
Office. The arbitrator shall resolve the inventorship dispute in
accordance with the laws of the United States within three (3) months of
his or her appointment. The parties agree to supply to the arbitrator such
documentary evidence of inventorship as they wish to rely upon together
with a written statement of their position not to exceed twenty (20) pages
in length within twenty (20) days of the appointment of the arbitrator.
Unless the Parties agree to rely on affidavits, the arbitrator shall set a
hearing at which each Party shall have up to eight (8) hours to present
witnesses and to cross examine the witnesses for the other Party. If there
is a hearing, each Party shall provide a statement summarizing the
testimony of each of its witnesses to the other Party and the arbitrator
at least fifteen (15) days in advance of the hearing. The arbitrator's
award shall be in writing not to exceed twenty (20) pages in length and
shall include reasoning in support of the award. The resolution of the
arbitrator shall be final and binding on the Parties, without right of
appeal.
20.3 CONFIDENTIALITY. All negotiations and proceedings under Sections 20.1 and
20.2 of this Article 20 shall be treated as Confidential Information in
accordance with the provisions of Article 11 (Confidentiality) of this
Agreement, and shall also be treated as compromise and settlement
negotiations for purposes of Rule 408 of the Federal Rules of Evidence and
comparable state rules of evidence. Any mediator or arbitrator shall be
bound by an agreement containing confidentiality provisions at least as
restrictive as those contained in Article 11 (Confidentiality) of this
Agreement.
20.4 EQUITABLE RELIEF. Nothing herein shall preclude either party from taking
whatever actions are necessary to prevent immediate, irreparable harm to
its interests. Otherwise, these procedures are exclusive and shall be
fully exhausted prior to the initiation of any litigation.
20.5 GOVERNING LAW; PERSONAL JURISDICTION: WAIVER OF JURY. Any questions,
claims, disputes, remedies or procedural matters arising out of or related
to this Agreement shall be
-20-
governed exclusively by the laws of the State of Delaware, without regard
to the principles of conflicts of law. The Parties agree that Minnesota
and Massachusetts have a substantial relationship to this transaction, and
each Party consents to personal jurisdiction in the courts of Minnesota
and Massachusetts and agree that if a suit is commenced by SEPRACOR it
shall be brought in Minnesota and if a suit is commenced by 3M or 3M IPC
it shall be brought in Massachusetts. THE PARTIES FURTHER HEREBY CONSENT
TO WAIVER OF ANY CONSTITUTIONAL, STATUTORY OR COMMON LAW RIGHT OF TRIAL BY
JURY.
IN WITNESS WHEREOF, the Parties, through their respective duly authorized
officers, have executed this Agreement to be effective as of the Effective Date
first above written.
Signed: John Sampson Title: Date: 12/20/01
------------------- --------------------- ---------
For and on behalf of 3M
Signed: Gary L. Griswold Title: Date: 12/20/01
------------------- --------------------- ---------
For and on behalf of 3M IPC
Signed: James O'Shea Title: President Date: 12/20/01
------------------- --------------------- ---------
For and on behalf of SEPRACOR
-21-
Schedule 1.12 -- Specifications (to be determined)
Schedule 1.7 -- Scale-up Program
Schedule 6.4 -- Pricing of Product for Clinical Supplies and Scale-Up batches
Schedule 6.6 -- Quality Assurance and Quality Control Responsibilities (to be
determined)
Page 1 of 3
Schedule 1.12 -- Specifications (to be determined)
Page 1 of 3
Confidential
Schedule 1.7 -- Scale-up Program
Page 1 of 3
SEPRACOR XOPENEX(R) HFA MDI PROCESS SCALE-UP PROJECT
December 12, 2001
GENERAL ASSUMPTIONS
- Project initiation is December 1, 2001.
- The plan is designed to develop a process that supplies nominal [**]-dose
product per US requirements.
- The plan assumes that the optimization runs will meet required
process/product acceptance criteria for a US product.
- Only 1 container/closure system is to be developed for the product assuming
use of Sepracor components. [**].
- The dates stated are all estimates. However, the earliest commercialization
date is a primary objective goal of both companies.
- The project is taken to the point that 3M provides the [**] manufacturing
process, DMF references and stability data portions of the NDA. The cost
estimates exclude additional time for 3M review and comments on the NDA
package, responses to FDA and responding to NDA deficiencies.
- No critical issues develop during the course of the project.
- OUS clinical supplies will not be needed from the registration batches.
- Process validation will not be performed until commercialization batches.
- NDA submission will occur after completion of the Sepracor generated
stability report covering the testing interval identified as required to
support the NDA submission. The NDA submission date will not necessarily be
contingent upon the availability of 12 months stability data. The NDA will
be amended with additional stability data as available.
- Product costs are in addition to development costs.
LAB PROCESS INVESTIGATIONS
- The Sepracor data package contains sufficient information on crimp
optimization to minimize 3M's investigation time.
- Sepracor will perform pharmaceutical performance testing on lab scale
samples to confirm equivalent product performance to the current process
prior to full scale batch manufacture.
- Appropriate clean testing studies and methods currently exist.
PROCESS OPTIMIZATION
- At least [**] lots (preferably more) of all raw materials provided by
Sepracor ([**]) are available to manufacture all [**] initial batches of
product.
- The manufacturing dates are not yet reserved. Availability of the
production facility will be based on the production schedule at the time
the development agreement is finalized. Delays in the plan may occur if
manufacturing conflicts are found.
Page 1 of 3
Confidential
SEPRACOR XOPENEX(R) HFA MDI PROCESS SCALE-UP PROJECT
December 12, 2001
- For initial process optimization purposes, [**] batches will be run at full
scale capacity ([**] units) with [**] at the edge of process tolerances
(high and low) and [**] at the nominal setpoints.
- In-process testing will be performed on the [**] nominal process batch
prior to manufacture of the [**] batches at nominal settings.
- The optimization batches will be filled in the following sequence: [**].
- The plan assumes that the first [**] lots of product manufactured at the
nominal process settings meet specifications. If the [**] batches are
found to be acceptable, they will be utilized for NDA clinical trials and
NDA stability testing.
- If the [**] batches at nominal process settings are placed on NDA stability
then batches #[**] and [**] will only be manufactured to provide
information for the process performance requirements for the CMC section of
the NDA.
- Batches [**] and [**] are not to be placed on NDA stability. This places a
higher risk on the stability performance of the first [**] batches.
- If the optimization runs are not successful in meeting acceptable
product/process criteria, additional optimizations will be required.
- Process maintenance runs are only listed through 2005, but will be
necessary on an annual basis until approval of the product.
REGISTRATION STABILITY/CLINICAL SUPPLIES
- Stability testing will be performed on nominal [**]-dose product only to
US requirements. Additional raw material or finished product testing for
OUS markets is not included in this plan.
- 3M will perform pivotal stability, according to a pie-defined protocoL
Responsibility for the testing of these samples will be shared between 3M
and Sepracor until analytical methods have been fully transferred to 3M.
Samples will be stored in stability ovens at both 3M and Sepracor during
this period.
- All stability protocols will be developed jointly by both Sepracor and 3M
prior to study initiation. 3M DDS will be responsible for developing all
manufacturing protocols which will be subject to Sepracor QA review. All
summary reports will he jointly reviewed by both Sepracor and 3M DDS.
- No lot will be placed into a clinical study until full review of the
resulting batch clearance testing and protocol sample testing and agreement
between Sepracor and 3M Drug Delivery. Testing, review and approval of data
should be targeted for completion within [**] weeks from availability of
samples.
- Release of the [**] batches at the nominal process settings for use in
clinical studies is to be contingent on review and consideration of the
test data from the [**] optimization batches at the extreme process
conditions.
- For interim stability testing intervals, Sepracor will accept and 3M may
provide QA data sheets within [**] weeks of the testing interval per agreed
upon format.
Page 2 of 3
SEPRACOR XOPENEX(R) HFA MDI PROCESS SCALE-UP PROJECT
December 12, 2001
+ Method crossovers will initially be between Sepracor and 3M St. Paul.
Analysts from St. Paul will perform the in-process testing for the
optimization batches. Method crossovers between 3M St. Paul and the
Northridge QC lab have been added as a separate set of tasks and will occur
at a later date to expedite method training and crossovers.
DEVELOPMENT COSTS
The following cost estimates assume full stability testing by 3M. Depending on
the timing of analytical method transfer from Sepracor to 3M, the actual 3M
Development Costs may be lower.
+ [**] batches at full scale ([**] units/each) = [**] units.
- This does not include process maintenance lots (estimated at [**]
per year until product approval).
Page 3 of 3
Schedule 6.4 - Pricing of Product for Clinical Supplies
Pricing of Product will be $[**] per unit based on theoretical batch size.
Pricing assumes:
- SEPRACOR provides Compound.
- SEPRACOR Components are canister, valve, actuator.
- 3M provides Samples to SEPRACOR in a bulk packaged unlabelled format.
- Batch size minimums are defined by 3M process.
- FOB 3M's manufacturing location.
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Schedule 6.6 - Quality Assurance and Quality Control Responsibilities (to be
determined)
-26-
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Exhibit 13
SEPRACOR INC. SELECTED FINANCIAL DATA
Year Ended December 31,
(In Thousands, Except Share and Per Share Data)
2001
2000
1999
1998
1997
STATEMENT OF OPERATIONS DATA:
Revenues:
Product sales
$
125,248
$
57,160
$
16,383
$
155
$
117
Royalties
25,663
2,573
2,000
243
204
Collaborative research and development
3,573
2,390
4,761
License fees and other
1,184
21,939
1,886
5,050
1,874
Total revenues
152,095
85,245
22,659
10,209
2,195
Costs and expenses:
Cost of revenue
15,904
14,334
4,919
575
541
Research and development
231,278
170,759
122,400
61,797
41,230
Selling, general and administrative and patent costs
131,386
98,398
65,336
30,123
12,609
Total costs and expenses
378,568
283,491
192,655
92,495
54,380
Loss from operations
(226,473
)
(198,246
)
(169,996
)
(82,286
)
(52,185
)
Other income (expense):
Interest income
25,669
41,919
21,896
13,191
5,639
Interest expense
(47,793
)
(47,760
)
(33,078
)
(16,969
)
(5,976
)
Equity in investee gains (losses)(1)
(1,601
)
3,501
(3,246
)
(7,482
)
(2,755
)
Other(2)
997
(7,051
)
272
(60
)
331
Gain on sale of affiliate stock(3)
23,034
30,069
Net loss before minority interest
(226,167
)
(207,637
)
(184,152
)
(93,606
)
(24,877
)
Minority interest in subsidiary
2,152
3,620
1,438
534
428
Net loss from continuing operations
(224,015
)
(204,017
)
(182,714
)
(93,072
)
(24,449
)
Discontinued operations:
Loss from discontinued operations (net of minority interest)(4)
(345
)
(211
)
(1,674
)
Net loss
$
(224,015
)
$
(204,017
)
$
(183,059
)
$
(93,283
)
$
(26,123
)
Net loss applicable to common shares(5)
$
(224,015
)
$
(204,017
)
$
(183,059
)
$
(93,433
)
$
(26,723
)
Basic and diluted net loss per common share from continuing operations
$
(2.89
)
$
(2.80
)
$
(2.77
)
$
(1.61
)
$
(0.44
)
Basic and diluted net loss per common share from discontinued operations
$
(0.00
)
$
(0.01
)
$
(0.04
)
Basic and diluted net loss per common share
$
(2.89
)
$
(2.80
)
$
(2.77
)
$
(1.62
)
$
(0.48
)
Shares used in computing basic and diluted net loss per common share:
Basic and diluted
77,534
72,757
66,049
57,826
55,198
BALANCE SHEET DATA:
Cash and short and long-term investments
$
904,389
$
634,479
$
335,823
$
499,597
$
92,560
Total assets
1,093,531
750,958
406,635
549,260
126,388
Long-term debt
1,260,817
853,916
490,611
491,910
83,736
Stockholders' equity (deficit)
$
(313,702
)
$
(214,674
)
$
(155,705
)
$
4,428
$
12,368
(1)
Represents
Sepracor's portion of BioSphere Medical, Inc. losses in 2001, Sepracor's portion of HemaSure Inc. losses and a gain of $5,000 resulting from the release of a HemaSure loan
guarantee in 2000 as a result of HemaSure Inc.'s repayment in full of the loan, and HemaSure Inc. and Versicor Inc. losses in 1999. Includes the write-off of a HemaSure line of credit guarantee in
1998. See Footnote CNotes to Consolidated Financial Statements.
(2)
Includes
$7,497 in expenses relating to prepaid interest and fees for the conversion of 6.25% convertible subordinated debentures in 2000.
1
(3)
Represents
Sepracor's gain on the sale of 2,600,000 shares of BioSphere Medical Inc. common stock in 2001 and Sepracor's gain on the sale of ChiRex Inc. in 1997.
(4)
Discontinued
operations relate to BioSphere Medical, Inc. See Footnote INotes to Consolidated Financial Statements.
(5)
Includes
$150 and $600 in preferred stock dividends in 1998 and 1997, respectively.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
This Annual Report to Stockholders contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning the
Company's business, operations and financial condition, including statements with respect to the safety, efficacy and potential benefits of the Company's products under development, expectations with
respect to development and commercialization of the Company's product candidates, the timing of the submission, acceptance and approval of regulatory filings, the scope of patent protection with
respect to these product candidates and the Company's products and information with respect to the other plans and strategies for the Company's business and the business of the subsidiaries. All
statements other than statements of historical facts included in this Annual Report to Stockholders regarding the Company's strategy, future operations, timetables for product testing, regulatory
approvals and commercialization, financial position, costs, prospects, plans and objectives of management are forward-looking statements. When used in this Annual Report to Stockholders, the words
"expect", anticipate", intend", "plan", "believe", "seek", "estimate", and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain
these identifying words. Because these forward-looking statements involve risks and uncertainties, actual results could differ materially from those expressed or implied by these forward-looking
statements for a number of important reasons, including those discussed under "Factors Affecting Future Operating Results", "Management's Discussion and Analysis of Financial Condition and Results of
Operations" and elsewhere in this Annual Report to Stockholders.
You
should read these statements carefully because they discuss the Company's expectations about its future performance, contain projections of the Company's future operating results or
its future financial condition, or state other "forward-looking" information. You should be aware that the occurrence of any of the events described in these risk factors and elsewhere in this Annual
Report to Stockholders could substantially harm the Company's business, results of operations and financial condition and that upon the occurrence of any of these events, the trading price of
Sepracor's common stock could decline.
Sepracor
cannot guarantee any future results, levels of activity, performance or achievements. The forward-looking statements contained in this Annual Report to Stockholders represent
the Company's expectations as of the date of this Annual Report to Stockholders and should not be relied upon as representing its expectations as of any other date. Subsequent events and developments
will cause the Company's expectations to change. However, while the Company may elect to update these forward-looking statements, it specifically disclaims any intention or obligation to do so, even
if its expectations change.
Overview
Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development and
commercialization of innovative pharmaceutical compounds including product candidates directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive
portfolio of pharmaceutical compounds that are focused
2
on the treatment of respiratory, urology and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.
The
consolidated financial statements include the accounts of Sepracor Inc. ("Sepracor" or the "Company") and its majority and wholly-owned subsidiaries, including BioSphere
Medical, Inc. ("BioSphere") (a consolidated subsidiary through July 2, 2001) and Sepracor Canada Limited. The consolidated financial statements also include equity ownership in
Sepracor's affiliate, HemaSure Inc. ("HemaSure"), and an investment in Versicor Inc. ("Versicor").
BioSphere
is an endovascular medical device company, pioneering the use of patented and proprietary bioengineered microspheres as a new class of embolotherapy devices. Sepracor owned
approximately 64% of BioSphere at December 31, 1999. On February 4, 2000, BioSphere completed a $5,900,000 private placement of common stock and warrants. As a result of this transaction,
Sepracor recorded a net gain of approximately $2,771,000 through additional paid-in capital and Sepracor's ownership of BioSphere decreased to approximately 59%. On July 31, 2000, BioSphere
sold approximately $13,000,000 of its common stock in a private equity placement. Of this amount, Sepracor purchased approximately $5,000,000 of BioSphere common stock. As a result of the transaction,
Sepracor recorded a net gain of approximately $1,702,000 through additional paid-in capital, and the Company's ownership in BioSphere decreased to approximately 56%. At December 31, 2000,
Sepracor's ownership in BioSphere was approximately 55%.
In
July 2001, Sepracor sold 2,000,000 shares of BioSphere common stock held by it in an underwritten public offering in which BioSphere also sold 2,000,000 shares of its common
stock at a price to the public of $11.00 per share. In August 2001, Sepracor sold an additional 600,000 shares of BioSphere common stock held by it at $11.00 per share pursuant to exercise of
the underwriters' over-allotment option. Sepracor received net proceeds, after offering costs, from the combined sales of approximately $26,526,000 and recognized a gain of approximately $23,034,000
in 2001. Sepracor recorded approximately $5,590,000 through additional paid-in capital as its gain on BioSphere's sale of 2,000,000 shares of BioSphere common stock. As a result of the public
offering, Sepracor's ownership in BioSphere has been reduced to approximately 25% as of December 31, 2001. Effective July 3, 2001, Sepracor no longer consolidates the results of
BioSphere and now records its investment in BioSphere under the equity method. Sepracor recorded $1,601,000 as its share of BioSphere losses for the period ended December 31, 2001.
HemaSure
had been applying its proprietary filtration technology to develop products to increase the safety of blood collection and transfusion. At December 31, 1999, Sepracor
owned approximately 27% of the outstanding shares of HemaSure common stock. In February 1999, the Company entered into an agreement with HemaSure pursuant to which Sepracor invested $2,000,000
in exchange for 1,333,334 shares of HemaSure common stock and for warrants to purchase approximately 667,000 of additional shares of HemaSure common stock. In October 1999, HemaSure completed a
private placement financing which resulted in Sepracor recording a gain of $820,000 through additional paid-in capital. On March 3, 2000, HemaSure completed a $28,000,000 private placement of
common stock. As a result of this transaction, Sepracor's ownership of HemaSure decreased to approximately 22% and Sepracor recorded a gain of approximately $1,417,000 through additional paid-in
capital. The Company also had a $5,000,000 liability at December 31, 1999, relating to a guarantee of a line of credit for HemaSure. In September 2000, HemaSure repaid the $5,000,000
line of credit, and as a result, Sepracor recorded a $5,000,000 equity in investee gain and removed the corresponding liability for the loan guarantee. Sepracor accounts for its investment in HemaSure
using the equity method of accounting. At December 31, 2001 and 2000, Sepracor's ownership in HemaSure was approximately 23% and 22%, respectively and its investment in HemaSure was recorded at
zero.
3
In February 2001, HemaSure signed an asset purchase agreement with Whatman plc. Under the terms of the agreement, Whatman agreed to purchase HemaSure's assets, except for cash,
cash equivalents and marketable securities of HemaSure, subject to certain exceptions as defined in the agreement. On May 29, 2001, HemaSure completed the sale to Whatman Bioscience Inc., a
Massachusetts corporation and a subsidiary of Whatman plc. Following the sale, HemaSure changed its corporate name to HMSR, Inc.
In
November 2001, HMSR, Inc. announced that it had signed a definitive agreement to merge with Point Therapeutics, Inc. Following the merger, HMSR's current
stockholders will own approximately 23% of the combined company. HMSR's stockholders voted to approve the merger at a stockholders' meeting held in March 2002.
Versicor
develops novel drug candidates principally for the treatment of infectious diseases. From December 10, 1997 through April 1999, Sepracor recorded Versicor's
results based on the equity method of accounting. As a result of various Versicor private equity offerings in 1999, Sepracor recorded a gain through additional paid-in capital of $1,077,000 in 1999
and began accounting for its investment under the cost method of accounting in April 1999. In 1999, Sepracor paid $1,000,000 to Versicor under a promissory note agreement, which was later
converted into Versicor preferred stock. In August 2000, Versicor completed an initial public offering of its common stock. As of December 31, 2000, Sepracor owned approximately 8% of
Versicor's outstanding common stock. Sepracor considers its investment in Versicor as an available-for-sale security and as such has marked to market its investment at the December 31, 2000
market price of $8.625 per share, which resulted in the recording of an unrealized gain of $10,688,000 as a separate component of stockholders' equity in 2000.
As
of December 31, 2001, Sepracor owns 1,809,143 shares, or approximately 8%, of Versicor's outstanding common stock. Sepracor also has warrants to purchase an additional 76,250
shares of Versicor common stock at $5.00 per share, which expire in December 2002. Sepracor recognized $1,252,000 as other income in 2001 for changes in the valuation of the warrants at
December 31, 2001. Sepracor has marked to market its investment in Versicor at the December 31, 2001 market price of $20.25 per share, which resulted in the recording of an unrealized
gain of $22,889,000 as a separate component of stockholders' equity in 2001.
In
May 1999, Sepracor introduced XOPENEX brand levalbuterol HCl, a single isomer of the bronchodilator albuterol. XOPENEX is the first pharmaceutical product developed and commercialized
by Sepracor.
During
2002, the Company expects to incur increasing operating expenses primarily due to expansion of research and development activities relating to development of the Company's
portfolio of pharmaceuticals and late stage drug candidates. Sales and marketing expenses are expected to increase in connection with a larger sales force. As a result, the Company expects to incur
operating losses for at least the next two years.
Revenue-Related Agreements
Tecastemizole.
Effective January 1998, Sepracor and Janssen Pharmaceutica, N.V., a wholly-owned subsidiary of
Johnson & Johnson ("Janssen"), entered into an agreement (the "Tecastemizole Agreement"; formerly referred to as the "Norastemizole Agreement"), relating to the development and marketing of
tecastemizole (formerly norastemizole), a third generation nonsedating antihistamine. Under the terms of the Tecastemizole Agreement, the companies agreed to jointly fund the development of
tecastemizole, and Sepracor granted to Janssen an option to acquire certain rights regarding the product in the United States and abroad. In May 1999, Sepracor announced that Johnson & Johnson
elected not to exercise its option to co-promote tecastemizole under the Tecastemizole Agreement. Sepracor continued to fund clinical development and marketing of the drug and submitted an NDA to the
U.S. Food and Drug Administration (the "FDA") for SOLTARA brand
4
tecastemizole in March 2001. Under the terms of the Tecastemizole Agreement, Sepracor has worldwide rights to make, use and sell prescription tecastemizole products under all Johnson &
Johnson intellectual property rights relating to tecastemizole, including the right to reference Johnson & Johnson's data for astemizole, in exchange for royalty payments on sales of
tecastemizole. Sepracor anticipates selling SOLTARA, if approved, through its own expanded sales force.
Fexofenadine.
In September 1999, Hoechst Marion Roussel Inc. (now Aventis) and Sepracor settled patent issues with
respect to fexofenadine, marketed by Aventis as ALLEGRA®, and amended their existing agreement (as so amended, the "Aventis Fexofenadine Agreement"). Under the terms of the U.S. Aventis
Fexofenadine Agreement, Aventis received all rights to Sepracor's patents with respect to fexofenadine and obtained an exclusive license to various Sepracor U.S. patent applications related to
fexofenadine. In October 1999, upon effectiveness of the amended Aventis Fexofenadine Agreement, Sepracor recognized license fee revenue of $1,875,000 from a milestone payment that had been previously
deferred. Sepracor has earned royalties on fexofenadine sales in the United States since February 2001. Under the terms of a separate ex-U.S. Aventis Fexofenadine Agreement, Aventis obtained an
exclusive license to Sepracor's patents related to fexofenadine, that had been the subject of litigation in Europe, as well as various other patent oppositions between the two companies outside the
United States. Sepracor has been entitled to royalties on fexofenadine product sales since March 1, 1999 in countries where Sepracor has patents related to fexofenadine. The Company recorded
$25,379,000, $2,495,000 and $1,746,000 of royalty revenues under the Aventis Fexofenadine Agreement in 2001, 2000 and 1999, respectively.
Levocetirizine.
In June 1999, Sepracor entered into a licensing agreement with UCB Farchim SA, an affiliate of UCB
("UCB"), relating to levocetirizine, an isomer of cetirizine, which is marketed by UCB as ZYRTEC® (the "UCB Agreement"), for the treatment of allergic rhinitis. Under the terms of the UCB
Agreement, Sepracor has exclusively licensed to UCB all of Sepracor's issued patents and pending patent applications relating to levocetirizine in all countries, except the United States and Japan.
Sepracor is entitled to receive royalties under the UCB Agreement upon first product sales and royalties will escalate upon achievement of sales volume milestones. In September 2001, UCB
announced that European Union Member States granted a positive opinion for levocetirizine, a single isomer of ZYRTEC, for the treatment of symptoms of seasonal allergic rhinitis (SAR), perennial
allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU), or hives of unknown cause, in adults and children aged 6 years and older. UCB has marketed levocetirizine under the brand names
XUSAL and XYZAL® in Germany since February 2001, and in 4 other European countries since the fourth quarter of 2001. UCB has received regulatory approval in 9 other
countries where Sepracor expects to earn royalties upon launch in 2002.
Desloratadine.
In December 1997, Sepracor licensed to Schering Plough Corporation ("Schering") exclusive worldwide
rights to Sepracor's patents covering desloratadine (the "DCL Agreement"), an active metabolite of loratadine, which is used as an antihistamine. In 1998, Schering paid Sepracor an initial license fee
of $5,000,000. Under the terms of the DCL Agreement, Sepracor is entitled to receive royalties on desloratadine sales, beginning at product launch. Royalties will escalate over time upon achievement
of sales volume and other milestones. On January 19, 2001, Schering received an approvable letter for desloratadine from the FDA, which indicated that the product could be approved pending
final approval by the FDA. On February 15, 2001, Schering announced that the FDA had issued reports citing deficiencies concerning Schering's compliance with current Good Manufacturing
Processes, or GMPs, and that the FDA had advised Schering that GMP deficiencies must be resolved prior to the FDA granting approval of desloratadine. In December 2001, Schering announced that
CLARINEX® (desloratadine) 5mg tablets had received marketing clearance from the FDA and Schering commercially launched CLARINEX in 2002.
5
Eszopiclone.
In October 1999, Sepracor entered into an agreement with Rhone-Poulenc Rorer SA (now Aventis) under which
Sepracor exclusively licensed Aventis' preclinical, clinical and post-marketing surveillance data package relating to zopiclone, its isomers and metabolites, to develop, make, use and sell eszopiclone
in the United States (the "Aventis Eszopiclone Agreement"). Under the Aventis Eszopiclone Agreement, Aventis assigned all U.S. patent applications relating to zopiclone to Sepracor, and Aventis
retained the right under the licensed data package to manufacture (S)-zopiclone in the U.S. for non-U.S. markets. In addition, Sepracor paid a $5,000,000 license fee to Aventis in 1999 and will pay a
royalty to Aventis on eszopiclone product sales in the U.S., if any. Sepracor recognized expense of $1,000,000 in 2000 based on the initiation of Phase III clinical trials of eszopiclone and may be
required to pay additional milestone payments to Aventis.
(R)-Fluoxetine.
In December 1998, Sepracor entered into an agreement with Eli Lilly and Company ("Lilly") under which
Sepracor granted to Lilly exclusive worldwide rights to Sepracor's patents
covering (R)-fluoxetine, a modified form of an active ingredient found in fluoxetine, marketed by Lilly as PROZAC (the "Lilly Agreement"). In April 2000, following completion of the Federal
Trade Commission review of the Lilly Agreement, the Company received an initial milestone payment and license fee of $20,000,000, which was recorded as license fee revenue in 2000. The Company also
recorded $3,573,000 of collaborative research and development revenue in 2000 related to previous costs incurred in the development of (R)-fluoxetine under the Lilly Agreement. In October 2000,
the Company was notified by Lilly that Lilly had terminated the exclusive license agreement covering (R)-fluoxetine. In accordance with the Lilly Agreement, Lilly has returned the existing scientific
data on the project to Sepracor. Given the extended development timetable and an assessment of the competitive environment, we have elected not to pursue development of (R)-fluoxetine at this time.
Ticalopride.
In July 1998, Sepracor entered into a license agreement with Janssen (the "Ticalopride Agreement";
formerly referred to as the "Norcisapride Agreement") giving Janssen exclusive worldwide rights to Sepracor's patents covering ticalopride ((+)-norcisapride), an isomer of the active metabolite of
Janssen's PROPULSID. Under the terms of the Ticalopride Agreement, Sepracor has exclusively licensed to Janssen rights to develop and market the ticalopride product worldwide. Under the Ticalopride
Agreement, Janssen has agreed to pay Sepracor royalties on ticalopride sales, if any, beginning at product launch in those countries where Sepracor has issued patents covering Janssen's approved
indications. Under the terms of the Ticalopride Agreement, the royalty rate to be paid to Sepracor will escalate upon the achievement of sales volume milestones. In April 2001, the Company was
notified by Janssen that clinical investigators were informed that two Phase II trials to evaluate the efficacy and safety of ticalopride in subjects with symptoms of GERD, or gastroparesis, were
being suspended pending further analysis of a small number of adverse events reported in GERD and diabetic patients. We continue to work with Johnson and Johnson to assess the data from the suspended
Phase II trials of ticalopride.
Results of Operations
Year Ended December 31, 2001 Compared to 2000
Product sales were $125,248,000 in 2001 as compared with $57,160,000 in 2000, an increase of 119%. Sales of XOPENEX, which Sepracor commercially introduced in May
1999, accounted for approximately 98% of 2001 product sales and 96% of 2000 product sales. The increase in product sales in 2001 as compared with 2000 is due primarily to increased unit volume sales
of XOPENEX.
Royalties
were $25,663,000 in 2001 as compared with $2,573,000 in 2000. The increase in 2001 as compared with 2000 is primarily due to increased royalties earned on sales of ALLEGRA in
2001, under the Aventis Fexofenadine Agreement in 2001. Sepracor began earning royalties on commercial sales of ALLEGRA in the United States during February 2001, in Japan during
November 2000 and in several other countries from 1999 to present.
6
License
fees and other revenues were $1,184,000 in 2001 as compared with $21,939,000 in 2000. License fee revenue in 2000 was comprised of a $20,000,000 milestone and license fee payment
recognized under the Lilly Agreement. Under the Lilly Agreement, Sepracor licensed to Lilly its patents covering (R)-fluoxetine. Other revenues represent revenues of BioSphere other than product
revenues recognized by BioSphere in connection with its core EmboSphere Microsphere business.
Collaborative
research and development revenues were $0 in 2001 as compared with $3,573,000 in 2000. Collaborative research and development revenues in 2000 were comprised of fees
recognized under the Lilly Agreement.
Cost
of products sold, as a percentage of product sales, was 12% in 2001 compared with 20% in 2000. The decrease in cost of products sold as a percentage of product sales in 2001 as
compared with 2000 was primarily due to lower XOPENEX manufacturing costs on a per unit basis due primarily to an increased number of units having been produced in 2001, as compared to 2000.
Cost
of license fees and other revenue was $493,000 in 2001 as compared with $3,056,000 in 2000. The cost of license fee revenue in 2000 was $2,000,000, which represents sublicense fees
owed by us under a license agreement with McLean Hospital pertaining to patents licensed by us to Lilly under the Lilly Agreement.
Research
and development expenses were $231,278,000 in 2001 as compared with $170,759,000 in 2000, an increase of 35%. The increase in 2001 as compared with 2000 is primarily due to
increased spending on preclinical and clinical studies in Sepracor's pharmaceutical programs, including (1) the initiation of new clinical studies for SOLTARA brand tecastemizole, and a NDA
submission to the FDA for tecastemizole, which was submitted in March 2001, (2) NDA preparation costs and Phase III clinical study costs relating to ESTORRA brand eszopiclone,
(3) the initiation of Phase III clinical studies for (S)-oxybutynin and the completion of Phase II clinical studies for (S)-oxybutynin, (4) the initiation of a Phase III clinical study
for (R,R)-formoterol and (5) the expenses related to several clinical trials for levalbuterol and new formulations of XOPENEX and the completion of a supplemental New Drug Application (an
"sNDA") for a pediatric formulation of XOPENEX, which was submitted to the FDA in March 2001.
Drug
development and approval in the U.S. is a multi-step process regulated by the FDA. The process begins with the filing of an IND, which, if successful, allows opportunity for
clinical study of the potential new drug. Clinical development typically involves three phases of study: Phase I, II and III. The most significant costs in clinical development are in the
Phase III clinical trials as they tend to be the longest and largest studies in the drug development process. Following successful completion of
Phase III clinical trials, an NDA must be filed with, and accepted by, the FDA, and the FDA must approve the NDA, prior to commercialization of the drug. Sepracor currently has four product
candidates in Phase III clinical studies and one NDA recently reviewed, but not approved, by the FDA. The successful development of the Company's product candidates is highly uncertain. An
estimation of product completion dates and completion costs can vary significantly for each product candidate and are difficult to predict. The lengthy process of seeking FDA approvals, and the
subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by the Company to obtain, or any delay in obtaining, regulatory approvals
could materially adversely affect the Company's business. The Company cannot assure you that any approval required by the FDA will be obtained on a timely basis, if at all.
For
additional discussion of the risks and uncertainties associated with completing development of potential product candidates, see "Factors Affecting Future Operating Results".
Below
is a summary of Sepracor's product candidates and the related stages of development for each product candidate in clinical development. The "Estimate of Completion of Phase" column
contains forward-looking statements regarding timing of completion of product development phases.
7
The actual timing of completion phases could differ materially from the estimates provided in the table. The table is sorted by highest to lowest spending amounts in 2001, and the 5 product
candidates listed accounted for approximately 90% of the Company's direct project research and development spending in 2001.
Product Candidate
Indication
Phase of
Development
Estimate of
Completion of Phase
ESTORRA (eszopiclone)
Sleep disorders
Phase III
2002
SOLTARA (tecastemizole)
RespiratoryAllergies
NDA
2003
*
S-Oxybutynin
Urinaryincontinence
Phase III
2003
R,R - Formoterol
RespiratoryAsthma
Phase III
2003
XOPENEX-MDI
RespiratoryAsthma
Phase III
2003
*
SOLTARA
received a "not-approvable" letter from the FDA in March 2002. The Company does not expect the SOLTARA NDA to receive FDA approval, if at all, before mid-2003.
Selling,
marketing and distribution expenses were $111,654,000 in 2001 as compared with $77,410,000 in 2000, an increase of 44%. The increase in 2001 as compared with 2000 is principally
due to additional salary and other payroll-related costs resulting from an increase in sales and marketing personnel, costs related to contracting with a third party contract sales organization,
marketing, promotion and advertising costs related to XOPENEX, and increased marketing costs in preparation for an anticipated SOLTARA brand tecastemizole product launch.
General
and administrative and patent costs were $19,732,000 in 2001 as compared with $20,988,000 in 2000, a decrease of 6%. The decrease in 2001 as compared with 2000 is primarily the
result of the consolidation of only six months of BioSphere costs in 2001 compared to twelve months in 2000. In 2001, Sepracor sold 2,600,000 shares of BioSphere common stock, which reduced Sepracor's
ownership in BioSphere to approximately 25%. Sepracor now records its investment in BioSphere under the equity method effective July 3, 2001.
Interest
income was $25,669,000 in 2001 as compared with $41,919,000 in 2000. The decrease in 2001 as compared with 2000 is due to lower average cash and short and long-term investment
balances available for investment and a decrease in the interest rates earned on investments in 2001.
Interest
expense was $47,793,000 in 2001 as compared with $47,760,000 in 2000. The slight increase in 2001 as compared with 2000 is due primarily to interest on the $500,000,000 of 5.75%
convertible subordinated notes that Sepracor issued in December 2001, partially offset by the conversion of $92,858,000 in principal amount of 6.25% convertible subordinated debentures in
February 2001.
Gain
on sale of BioSphere stock was $23,034,000 in 2001 as compared with $0 in 2000. This gain represents Sepracor's net gain on Sepracor's sale of 2,600,000 shares of BioSphere common
stock as part of a public offering by BioSphere in July and August 2001.
Equity
in investee gains (losses) were ($1,601,000) in 2001 as compared with $3,501,000 in 2000. The equity in investee loss in 2001 represents Sepracor's portion of BioSphere losses for
2001. In 2000, the net equity in investee gain consists of Sepracor's portion of the net loss of HemaSure of ($1,499,000), offset by a gain of $5,000,000 from the release of a loan guarantee for
HemaSure.
Net
other income (expense) was $997,000 in 2001 as compared with ($7,051,000) in 2000. Other income in 2001 primarily represents income of $1,252,000 recognized on the increased
valuation of Versicor warrants being recorded as a derivative. Other expense in 2000 primarily represents inducements and other costs of $7,497,000 from the conversion of $96,424,000 in principal
amount of Sepracor's 6.25% convertible subordinated debentures.
8
Minority
interest in subsidiaries (net of discontinued operations) resulted in a reduction of consolidated net loss of $2,152,000 in 2001 as compared with $3,620,000 in 2000. The
decrease in minority interest is due to Sepracor's sale of 2,600,000 shares of BioSphere common stock, which resulted in a reduction of its ownership in BioSphere from approximately 55% to 25% as of
December 31, 2001. Sepracor no longer consolidates BioSphere and now records its investment in BioSphere under the equity method, effective July 3, 2001.
Year Ended December 31, 2000 Compared to 1999
Product sales were $57,160,000 in 2000 as compared with $16,383,000 in 1999, an increase of 249%. Sales of XOPENEX, which Sepracor commercially introduced in May
1999, accounted for approximately 96% of 2000 product sales as compared with 86% of 1999 product sales. The increase in product sales in 2000 as compared with 1999 is due primarily to increased unit
volume sales of XOPENEX.
Royalties
were $2,573,000 in 2000 as compared with $2,000,000 in 1999. The increase in 2000 as compared with 1999 is primarily due to increased royalties earned on sales of ALLEGRA in
2000 under the Aventis Fexofenadine Agreement.
License
fees and other revenues were $21,939,000 in 2000 as compared with $1,886,000 in 1999. The increase in 2000 as compared with 1999 is primarily due to a $20,000,000 milestone and
license fee payment recognized under the Lilly Agreement in 2000. Other revenues represent revenues of BioSphere other than product revenues recognized by BioSphere in connection with its core
EmboSphere Microsphere business.
Collaborative
research and development revenues were $3,573,000 in 2000 as compared with $2,390,000 in 1999. The increase in 2000 as compared with 1999 is due to collaborative research
and development revenue recognized in 2000 under the Lilly Agreement. Collaborative research and development revenues in 1999 were comprised of fees recognized under the Tecastemizole Agreement.
Cost
of products sold, as a percentage of product sales, was 20% in 2000 as compared with 29% in 1999. The decrease in cost of products sold as a percentage of product sales in 2000 as
compared with 1999 is due primarily to an increase in sales of XOPENEX pharmaceutical products as a percentage of total product sales, which have a lower cost as a percentage of product sales, as
compared to non-pharmaceutical product sales. Pharmaceutical products represent primarily XOPENEX. Non-pharmaceutical products represent BioSphere's products, including BioSphere's EmboSphere
Microsphere line of medical devices. Pharmaceutical product sales represented approximately 96% of total product sales in 2000 as compared with approximately 86% of total product sales in 1999.
Additionally, the cost of non-pharmaceutical product sales as a percentage of non-pharmaceutical product sales declined significantly in 2000 as BioSphere began to increase sales of its higher margin
EmboSphere Microspheres.
Cost
of license fee and other revenue was $3,056,000 in 2000 as compared with $108,000 in 1999. The cost of license fee revenue in 2000 was $2,000,000, which represents sublicense fees
owed by us under a license agreement with McLean Hospital pertaining to patents licensed by us to Lilly under the Lilly Agreement.
Research
and development expenses were $170,759,000 in 2000 as compared with $122,400,000 in 1999, an increase of 40%. The increase in 2000 as compared with 1999 is primarily due to
increased spending on preclinical and clinical studies in Sepracor's pharmaceutical programs, including (1) the initiation of 15 new studies for tecastemizole and preparation efforts of an NDA
for submission to the FDA for tecastemizole, which was submitted in March 2001, (2) the initiation of 17 new studies for eszopiclone, formerly (S)-zopiclone, including two Phase III studies,
(3) the completion of a major phase IIb/III study for (S)-oxybutynin, (4) the completion of a Phase II study for (R,R)-formoterol and
9
(5) the expenses related to several trials for levalbuterol and new formulations of XOPENEX. In 2000, the Company initiated several other preclinical and clinical studies and submitted an
Investigational New Drug application ("IND") for the (S)-sibutramine metabolite for the treatment of sexual dysfunction.
See
the discussion relating to research and development expenses for the year ended December 31, 2001 compared to 2000. The research and development spending in 2000 and 1999 was
concentrated on the same product candidates described in the 2001 discussion.
Selling,
marketing and distribution costs were $77,410,000 in 2000 as compared with $48,211,000 in 1999, an increase of 61%. The increase in 2000 as compared with 1999 is principally due
to increased salary and other payroll related costs resulting from an increase in sales and marketing personnel, costs resulting from contracting with two third party contract sales organizations, and
marketing, promotion and advertising costs related to XOPENEX.
General
and administrative and patent costs were $20,988,000 in 2000 as compared with $17,125,000 in 1999, an increase of 23%. The increase in 2000 as compared with 1999 is primarily due
to $1,381,000 of additional amortization of deferred financing costs, $345,000 of additional insurance costs and $1,081,000 of additional BioSphere amortization of goodwill and stock-based
compensation costs in 2000.
Interest
income was $41,919,000 in 2000 as compared with $21,896,000 in 1999. The increase in 2000 as compared with 1999 is due to larger average cash and short and long-term investment
balances available for investment primarily as a result of the sale of $460,000,000 of 5% convertible subordinated debentures in February 2000.
Interest
expense was $47,760,000 in 2000 as compared with $33,078,000 in 1999. The increase in 2000 as compared with 1999 is due primarily to interest on the $460,000,000 of 5%
convertible subordinated debentures issued in February 2000.
Equity
in investee gains (losses) were $3,501,000 in 2000 as compared with ($3,246,000) in 1999. In 2000, the net gain in equity of investees consists of the Company's portion of the net
loss of HemaSure of ($1,499,000) offset by a gain of $5,000,000 from the release of a loan guarantee for HemaSure. In 1999, the net loss in equity of investees consists of the Company's portion of the
net loss of HemaSure of ($2,737,000) and the Company's portion of the net loss of Versicor of ($509,000).
Net
other income (expense) was ($7,051,000) in 2000 as compared with $272,000 in 1999. Other expense in 2000 is primarily the result of inducements and other costs of $7,497,000 from the
conversion of $96,424,000 in principal amount of Sepracor's 6.25% convertible subordinated debentures.
Minority
interest in subsidiaries (net of discontinued operations) resulted in a reduction of consolidated net loss of $3,620,000 in 2000 as compared with $1,438,000 in 1999. The
increase in 2000 as compared with 1999 is due to increased losses of BioSphere and an increase in the Company's minority ownership of BioSphere to 45% in 2000 as compared with 36% in 1999.
Other
Critical Accounting Policies
In December 2001, the Securities and Exchange Commission, or SEC, requested that all registrants discuss their most "critical accounting policies" in
management's discussion and analysis of financial condition and results of operations. The SEC indicated that a "critical accounting policy" is one which is both important to the portrayal of the
company's financial condition and results and requires management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that
are inherently uncertain. While our significant accounting
10
policies are more fully described in Note B to our consolidated financial statements included in this report, we believe the following accounting policies to be critical:
Revenue Recognition:
Sepracor recognizes revenue from product sales when title to product and associated risk of loss has passed to the
customer, and collectability is reasonably assured. All revenues from product sales are recorded net of applicable allowances for returns, rebates and other applicable discounts and allowances.
License
fees and other revenue include non-refundable upfront license fees, milestones, and other revenue. Non-refundable upfront license fees are recorded as
revenue over the related performance period or at such time when there are no remaining performance obligations. Milestones are recorded as revenue when achieved and only if there are no remaining
performance obligations and the fees are non-refundable. Other revenue includes revenues recognized by BioSphere unrelated to its core EmboSphere Microsphere business.
Sepracor
records collaborative research and development revenue from research and development contracts over the term of the applicable contract, as it incurs costs related to the
contract.
Royalty Revenue Recognition:
Royalty revenue is recognized based upon estimates of sales in licensed territories in the period in which the
sales occur. These estimates are derived from information from the company paying the royalty when possible, or from historical data and third party prescription data. Changes in market conditions,
such as the introduction of competitive products, can lead to significant deviations from historical patterns and therefore cause estimates to be inaccurate. When estimates differ from actual results,
the difference is recognized in the following quarter, provided the difference is not material to the results of either quarter. If the difference was considered material, it would be adjusted in the
quarter in which the discrepancy occurred.
Rebate and Return Reserves:
Certain product sales qualify for rebates from standard list pricing due to government sponsored programs or
other contractual agreements. The Company also allows for return of its product for up to one year after product expiration. Reserves for product returns and rebates are derived through an analysis of
historical experience updated for changes in facts and circumstances as appropriate and by utilizing reports obtained from external, independent sources. If government contracts change materially, the
associated reserves estimated for those programs can change significantly. Estimates of reserves for returns are impacted by the extended return cycle, and by other factors such as introduction of a
new competitive product, or other change in market conditions leading to a change in historical return patterns.
Patents, Intangible Assets and Other Assets:
Major assets capitalized include third party patents and licenses purchased, as well as
deferred financing costs. Long-lived assets are reviewed for impairment by comparing the undiscounted projected cash flows of the related assets with their carrying amount. Any write-downs are treated
as permanent reductions in the carrying amount of the assets.
The
Company currently has long-lived assets, which include patents on drug compounds in late stages of clinical development but not yet successfully developed or approved. If any of
these drug compounds fails to receive final FDA approval, we could potentially have material write-downs of assets related to the drug compounds.
Accounts Receivable and Bad Debt:
Sepracor's trade receivables in 2001 and 2000 primarily represent amounts due to the Company from
wholesalers, distributors and retailers of its pharmaceutical product. Sepracor performs ongoing credit evaluations of its customers and generally does not require collateral. Bad debt write-offs were
not significant in 2001, 2000 and 1999; however the Company monitors its receivables closely due to few customers making up a large portion of the overall revenues.
11
Recent Accounting Pronouncements
In June 2001, the Financial Accounting Standards Board, or FASB, issued Statement of Financial Accounting Standards, or SFAS No. 141, "Business
Combinations" and SFAS No. 142, "Goodwill and Other Intangible Assets." SFAS No. 141 requires that all business combinations be accounted for under the purchase method and that certain acquired
intangible assets in a business combination be recognized as assets apart from goodwill. SFAS No. 142 requires that ratable amortization of goodwill and certain intangible assets be replaced
with periodic tests of the goodwill's impairment and that intangible assets be amortized over their useful lives. SFAS No. 141 is effective for all business combinations initiated after
June 30, 2001 and for all business combinations accounted for by the purchase method for which the date of acquisition is after June 30, 2001. The provisions of SFAS No. 142 will
be effective for fiscal years beginning after December 15, 2001, and will thus be adopted by us in fiscal year 2002. However, for goodwill and intangible assets acquired after June 30,
2001, certain provisions of SFAS 142 will be effective from the date of acquisition. The Company notes that SFAS No. 141 does not currently have any effect on the reported financial results and does
not expect the adoption of SFAS No. 142 to have a material impact on the Company's financial statements and related disclosures.
In
June 2001, the FASB issued SFAS No. 143, "Accounting for Asset Retirement Obligations." This statement addresses financial accounting and reporting for obligations
associated with the retirement of tangible long-lived assets and the associated asset retirement costs. This statement applies to all entities. It applies to legal obligations associated with the
retirement of long-lived assets that result from the acquisition, construction, development and/or the normal operation of a long-lived asset, except for certain obligations of lessees. This statement
is effective for financial statements issued for fiscal years beginning after June 15, 2002. The Company does not believe that the adoption of this standard will have a material impact on the
Company's financial statements and related disclosures.
In
August 2001, the FASB issued SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets," which supercedes SFAS No. 121, "Accounting for the
Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of." SFAS No. 144 further refines the requirements of SFAS No. 121 that companies (1) recognize an
impairment loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows and (2) measure an impairment loss as the difference between the
carrying amount and fair value of the asset. In addition, SFAS No. 144 provides guidance on accounting and disclosure issues surrounding long-lived assets to be disposed of by sale. The Company
will adopt SFAS No. 144 during the first quarter of 2002 and does not believe that the adoption of this standard will have a material impact on the Company's financial statements and related
disclosures.
Liquidity and Capital Resources
Our liquidity requirements have historically consisted of research and development expenses, sales and marketing expenses, capital expenditures, working capital,
debt service and general corporate expenses. We have funded these requirements and the growth of our business through convertible subordinated debt offerings, the issuance of common stock, including
the exercise of stock options, and sales of product and license agreements for our drug compounds. The Company expects to meet its short-term liquidity needs through the use of its cash and short-term
investments on hand at December 31, 2001.
Cash Flows
Cash, cash equivalents and short and long-term investments totaled $904,389,000 at December 31, 2001, compared to $634,479,000 at December 31, 2000.
12
The
net cash used in operating activities for the year ended December 31, 2001 was $208,419,000. The net cash used in operating activities includes a net loss from continuing
operations of $224,015,000 adjusted by non-cash charges of $15,081,000. These charges were offset by the gain on the sale of BioSphere common stock of $23,034,000 and the minority interest in
subsidiary portion of the net loss of $2,152,000. Accounts receivable increased by $8,718,000 due primarily to the increased sales of XOPENEX during December 2001 versus December 2000, and
inventory increased by $4,581,000 primarily due to increased production of XOPENEX inventory. Other current assets increased by $5,425,000 primarily due to royalty receivables related the Aventis
Fexofenadine Agreement. The accounts payable and accrued expense amounts increased a total of $34,353,000 primarily due to the timing of cash disbursements and increased research and development, and
sales and marketing activities. Other current liabilities increased by $10,072,000 primarily due to additional accruals for product revenue rebates and return reserves as a result of increased XOPENEX
revenues.
The
net cash provided by investing activities for the year ended December 31, 2001 was $77,400,000. Cash provided by net sales of short and long-term investments was $91,078,000,
and net proceeds from the sale of BioSphere stock was $26,526,000 partially offset by the deconsolidation of BioSphere's cash of $9,405,000 and purchases of property and equipment of $28,688,000.
Included in purchases of property and equipment is $13,093,000 of loan receivable from a construction loan agreement with a third party related to the construction of a new corporate and research and
development building in Marlborough, Massachusetts. Sepracor has recorded the amounts loaned as construction in progress on the balance sheet in accordance with EITF 97-10.
Sepracor
expects purchases of property and equipment costs to be approximately $50,000,000 to $55,000,000 in 2002, of which $14,225,000 represents an additional advance under the
construction loan agreement with a third party related to the construction of a new corporate and research and development building in Marlborough, Massachusetts, approximately $12,000,000 is
furniture, fixtures, and leasehold improvements related to the new building and $16,000,000 is for computer equipment and software. The Company expects depreciation to be approximately $12,000,000 to
$15,000,000 in 2002. Sepracor has an option to purchase the land and building being constructed upon its completion in June 2002 and extending through January 2004, at a purchase price
estimated to be $38,000,000. If Sepracor elects to purchase the building, the construction loan outstanding, estimated to be $27,319,000 at June 2002, would be repaid to Sepracor.
The
net cash provided by financing activities for the year ended December 31, 2001 was $491,662,000. The Company received approximately $486,018,000 in net proceeds from the issuance of
the $500,000,000 in aggregate principal amount of 5.75% convertible subordinated notes. The Company also received approximately $4,701,000 in proceeds from the issuance of approximately 309,000 shares
of common stock under its employee stock plans.
Sepracor
does not have any off-balance sheet arrangements, or special purpose entities or activities that include non-exchange traded contracts accounted for at fair value.
Sepracor's
wholly-owned subsidiary, Sepracor Canada Limited, has an interest free credit agreement with a Canadian provincial business development agency for approximately $370,000 in
term debt. At December 31, 2001, Sepracor Canada Limited had received approximately $370,000 of such term debt, of which approximately $78,000 remains outstanding. Sepracor Canada Limited also
has a Canadian Government grant which may be repayable if Sepracor Canada Limited fails to meet certain conditions. The grant is recorded as debt and is being amortized over the useful lives of the
related capital assets. The unamortized balance as of December 31, 2001 was approximately $779,000.
Line of Credit
Sepracor is party to a revolving line of credit agreement with a commercial bank (the "Revolving Credit Agreement"), which provides for borrowing of up to
$25,000,000. In December 2001, Sepracor
13
amended its Revolving Credit Agreement to remove BioSphere as a party and extended the term to March 31, 2002. Sepracor intends to seek to extend the Revolving Credit Agreement in 2002.
Sepracor may not be able to successfully extend the Revolving Credit Agreement or negotiate a revolving line of credit with another commercial bank. Interest is payable monthly in arrears at prime
(4.75% at December 31, 2001) or the LIBOR rate (1.9% at December 31, 2001) plus .75%. All borrowings are collateralized by certain assets of the Company. The Revolving Credit Agreement
contains covenants relating to minimum tangible capital base, minimum cash or cash equivalents, minimum liquidity ratio
and maximum leverage. At December 31, 2001 and 2000, no amounts were outstanding under the Revolving Credit Agreement.
Convertible Subordinated Debt
In February 1998, Sepracor issued $189,475,000 in principal amount of 6.25% convertible subordinated debentures due 2005 (the "6.25% Debentures"). The
6.25% Debentures were convertible into Sepracor common stock, at the option of the holder, at a price of $23.685 per share and bore interest at 6.25% payable semi-annually, commencing on
August 15, 1998. The 6.25% Debentures were redeemable by the Company commencing February 2001. As part of the sale of the 6.25% Debentures, Sepracor incurred approximately $6,105,000 of
offering costs, which were recorded as other assets and were being amortized over seven years, the term of the 6.25% Debentures. The net proceeds to the Company after offering costs were approximately
$183,370,000.
In
February 2000, Sepracor converted $96,424,000 in principal amount of its 6.25% Debentures. Costs related to the conversion of the 6.25% Debentures, including inducements and
other costs of approximately $7,497,000, were recorded as other expense. As a result of the conversion, Sepracor issued 4,071,176 shares of Sepracor common stock and wrote off approximately $2,373,000
of deferred finance costs against additional paid-in capital.
In
January 2001, the Company announced that on February 21, 2001 it would redeem the $92,858,000 in principal amount of 6.25% Debentures that remained outstanding. On
February 20, 2001, prior to the redemption, all outstanding 6.25% Debentures were converted. As a result of the conversion, Sepracor issued 3,920,608 shares of Sepracor common stock and wrote
off approximately $1,525,000 of deferred finance costs against additional paid-in capital.
In
December 1998, Sepracor issued $300,000,000 in principal amount of 7% convertible subordinated debentures due 2005 (the "7% Debentures"). The 7% Debentures are convertible into
Sepracor common stock, at the option of the holder, at a price of $62.4375 per share and bear interest at 7% payable semi-annually, commencing on June 15, 1999. The 7% Debentures were not
redeemable by the Company until December 20, 2001. The Company may be required to repurchase the 7% Debentures at the option of the holders if there was a change in control of the Company. As
part of the sale of the 7% Debentures, Sepracor incurred approximately $9,919,000 of offering costs, which were recorded as other assets and are being amortized over seven years, the term of the 7%
Debentures. The net proceeds to the Company after offering costs were approximately $290,081,000.
In
February 2000, Sepracor issued $400,000,000 in principal amount of 5% convertible subordinated debentures due 2007 (the "5% Debentures"). On March 9, 2000, Sepracor
issued an additional $60,000,000 in principal amount of 5% Debentures pursuant to an option granted to the initial purchaser of the 5% Debentures. The 5% Debentures are convertible into Sepracor
common stock, at the option of the holder, at a price of $92.38 per share and bear interest at 5% payable semi-annually,
commencing on August 15, 2000. The 5% Debentures are redeemable by the Company prior to February 15, 2003 if the trading price of Sepracor common stock exceeds 150% of the conversion
price ($138.57) for 20 trading days in a period of 30 consecutive trading days. The 5% Debentures are redeemable by the Company on or after February 15, 2003 if the trading price of Sepracor
common stock exceeds 120% of the conversion price ($110.86) for 20 trading days in a period of 30 consecutive
14
trading days. The Company may be required to repurchase the 5% Debentures at the option of the holders if there is a change in control of the Company. As part of the sale of the 5% Debentures,
Sepracor incurred approximately $14,033,000 of offering costs, which were recorded as other assets and are being amortized over seven years, the term of the 5% Debentures. The net proceeds to the
Company after offering costs were approximately $445,967,000.
In
November 2001, Sepracor issued $400,000,000 in principal amount of 5.75% convertible subordinated notes due 2006 (the "5.75% Notes"). In December 2001, Sepracor issued
an additional $100,000,000 in principal amount of 5.75% Notes pursuant to an option granted to the initial purchaser of the 5.75% Notes. The 5.75% Notes are convertible into Sepracor common stock, at
the option of the holder, at a price of $60.00 per share. The 5.75% Notes bear interest at 5.75% payable semiannually, commencing on May 15, 2002. The 5.75% Notes are convertible at the option of the
Company prior to maturity if the closing price of Sepracor common stock exceeds 145% of the conversion price ($87.00) for at least 20 out of 30 consecutive trading days ending within five trading days
prior to notice of conversion. The Company may be required to repurchase the 5.75% Notes at the option of the holders if there is a change in control of the Company. As part of the sale of the 5.75%
Notes, Sepracor has incurred offering costs of approximately $13,982,000 and expects to incur total costs of $14,500,000 which have been recorded as other assets and are being amortized over five
years, which is the term of the 5.75% Notes. The estimated net proceeds to the Company after offering costs are expected to be approximately $485,500,000.
Sale of BioSphere Common Stock; Change to Equity Method of Accounting
In July 2001, Sepracor sold 2,000,000 shares of BioSphere common stock held by it in a public offering in which BioSphere also sold 2,000,000 shares of its
common stock at a price to the public of $11.00 per share. On August 2, 2001, the underwriters exercised their over-allotment option to purchase an additional 600,000 shares of BioSphere common
stock from Sepracor at a price to the public of $11.00 per share. Sepracor received net proceeds, after offering costs, from the sale of BioSphere common stock of approximately $26,526,000 and has
recognized a gain of approximately $23,034,000 in 2001. Sepracor recorded approximately $5,590,000 through additional paid-in capital as its gain on BioSphere's sale of 2,000,000 shares of BioSphere
common stock. As a result of the public offering, Sepracor's ownership in BioSphere has been reduced from approximately 55% to 25% as of December 31, 2001. Sepracor no longer consolidates
BioSphere and now records its investment in BioSphere under the equity method, effective July 3, 2001. Sepracor has recorded $1,601,000 as its share of BioSphere losses for the six months ended
December 31, 2001.
We
have summarized below our material contractual cash obligations as of December 31, 2001.
Contractual Obligations (In Thousands)
Total
Less Than One
Year
(2002)
One to Three
Years
(2003-2005)
Four to Five
Years
(2006-2007)
After Five
Years
(after 2007)
Convertible subordinated debtprincipal(1)
$
1,259,960
$
299,960
$
960,000
Convertible subordinated debtinterest(1)
342,739
72,747
218,242
51,750
Capital lease obligations
1,284
579
705
Operating leases
5,000
1,247
2,540
1,213
Long-term debt
78
67
11
Total material contractual cash obligations
$
1,609,061
$
74,640
$
521,458
$
1,012,963
(1)
If
the convertible subordinated debt were converted into common stock these amounts would no longer be a contractual cash obligation.
15
The
Company's 7% Debentures, 5% Debentures and 5.75% Notes are currently trading at discounts to their respective face amounts. Accordingly, in order to reduce future cash interest
payments, as well as future amounts due at maturity, Sepracor has, subsequent to December 31, 2001 and through March 27, 2002, exchanged approximately $97,000,000 of its convertible
subordinated debt in privately negotiated transactions, for approximately 3,541,000 shares of its common stock. Sepracor, may from time to time, depending on market conditions, exchange shares of
Sepracor common stock for additional outstanding convertible subordinated debt, and the number of shares that it might issue as a result of such exchanges would significantly exceed the number of
shares originally issuable upon conversion of such debt. Accordingly such exchanges could result in material dilution to holders of Sepracor common stock. There can be no assurance that Sepracor will
exchange any or all of its outstanding convertible subordinated debt for shares of Sepracor common stock.
The
Company has had no material related party activities in 2001, other than those relating to conversion of BioSphere common stock.
The
Company believes its existing cash and the anticipated cash flow from its current strategic alliances and operations will be sufficient to support existing operations through 2003.
Sepracor's actual future cash requirements, however, will depend on many factors, including the progress of its preclinical, clinical, and research programs, the number and breadth of these programs,
achievement of milestones under these strategic alliance arrangements, sales of its products, acquisitions, its ability to establish and maintain additional strategic alliances and licensing
arrangements, and the progress of the Company's development efforts and the development efforts of its strategic partners. Based on its current operating plan, the Company believes that it will not be
required to raise additional capital to fund the repayment of its outstanding convertible debt when due. However, if the Company is not able to commercialize its current late-stage products, including
both SOLTARA and ESTORRA, or if such products do not achieve expected sales levels, Sepracor may be required to raise additional funds in order to repay its outstanding convertible debt and there can
be no assurance that, if required, Sepracor would be able to raise such funds on favorable terms, if at all.
Market Risk
The Company is exposed to market risk from changes in interest rates and equity prices, which could affect its future results of operations and financial
condition. The Company manages its exposure to these risks through its regular operating and financing activities.
Interest
Rates: Although the Company's investments are subject to credit risk and interest rate risk, the Company's investment policy specifies credit quality standards for its
investments and the Company's investment portfolio is always in compliance with its investment policy. The primary objective of the
investment policy is the preservation of capital. Due to the conservative nature of the Company's investments and relatively short duration, interest rate risk is mitigated.
The
interest rates on the Company's convertible subordinated debentures and capital lease obligations are fixed and therefore not subject to interest rate risk.
Equity
Prices: The Company's convertible subordinated debt is sensitive to fluctuations in the price of the Company's common stock into which the debt is convertible. Changes in equity
prices would result in changes in the fair value of the Company's convertible subordinated debt due to the difference between the current market price of the debt and the market price at the date of
issuance of the debt. A 10% decrease in the price of the Company's common stock at December 31, 2001 could result in a decrease of approximately $126 million on the net fair value of the Company's
convertible subordinated debt.
Legal Proceedings
Currently, Sepracor is not party to any material legal proceedings.
16
Factors Affecting Future Operating Results
Certain of the information contained in this Annual Report, including information with respect to the safety, efficacy and potential benefits of the Company's
drugs under development and the scope of patent protection with respect to these products and information with respect to the other plans and strategies for the Company's business and the business of
the subsidiaries and certain affiliates of the Company, consists of forward-looking statements. The forward-looking statements contained in this Annual Report represent our expectations as of the date
of this Annual Report. Subsequent events will cause our expectations to change. However, while we may elect to update these forward-looking statements, we specifically disclaim any intention or
obligation to do so. Important factors that could cause actual results to differ materially from the forward-looking statements include the following:
WE HAVE NEVER BEEN PROFITABLE AND WE MAY NOT BE ABLE TO GENERATE REVENUES SUFFICIENT TO ACHIEVE PROFITABILITY.
We have not been profitable
since inception, and it is possible that we will not achieve profitability. We incurred net losses applicable to common shares on a consolidated basis of approximately $224.0 million for the year
ended December 31, 2001 and $204.0 million for the year ended December 31, 2000. As a result, in part, of the FDA's issuance of a "not-approvable" letter with respect to SOLTARA, we
anticipate that our net loss in fiscal 2002 will exceed
that incurred in fiscal 2001. We expect to continue to incur significant operating and capital expenditures. As a result, we will need to generate significant revenues to achieve and maintain
profitability. We cannot assure you that we will achieve significant revenues or that we will ever achieve profitability. Even if we do achieve profitability, we cannot assure you that we can sustain
or increase profitability on a quarterly or annual basis in the future. If revenues grow more slowly than we anticipate or if operating expenses exceed our expectations or cannot be adjusted
accordingly, our business, results of operations and financial conditions will be materially and adversely affected.
IF WE OR OUR DEVELOPMENT PARTNERS ARE NOT SUCCESSFUL IN DEVELOPING AND COMMERCIALIZING OUR PRINCIPAL PRODUCTS UNDER DEVELOPMENT, THEN OUR ABILITY TO BECOME
PROFITABLE WILL BE ADVERSELY AFFECTED.
Our ability to generate profitability will depend in large part on successful commercialization of our initial products and successful
development and commercialization of principal products under development. Failure to successfully commercialize our products and products under development may have a material adverse effect on our
business. In March 2002, we were informed by the FDA that it issued a "not approvable" letter for our NDA for SOLTARA brand tecastemizole 15 mg and 30 mg capsules. While we had expected to
launch SOLTARA in the U.S. during 2002, we will not be able to commercialize SOLTARA unless and until we receive approval from the FDA. Currently, we do not expect to receive approval, if at all, for
at least one year. In addition, in response to issues raised by the FDA regarding completeness of our NDA for eszopiclone, we are conducting additional preclinical studies to support use of RPR's
preclinical data package, including carcinogenicity studies. Assuming favorable results from the ongoing studies, we anticipate submitting an NDA for eszopiclone to the FDA in 2002, which, if
approved, we would market under the name ESTORRA. Before we commercialize any of our product candidates, we will need to file an NDA, and the FDA will need to approve the NDA. If the FDA delays or
denies approval of any NDA that we file in the future, then successful commercialization of our products under development may be delayed or terminated, which could have a material adverse effect on
our business.
We
are entitled to receive royalties on sales, if any, of ticalopride under our agreement with Janssen. In April 2001, Janssen announced that it had suspended clinical trials of
ticalopride pending further analysis of a small number of adverse events reported in patients. We do not know if or when ticalopride may be approved or the timing of commercialization of ticalopride.
In addition, if other collaborative agreements are terminated or commercialization efforts under those agreements are delayed or unsuccessful, then successful commercialization of the products under
development may be
17
delayed or terminated and our royalty revenues could be delayed and/or reduced, which could have a material adverse effect on our business.
In
May 2001, an advisory panel to the FDA recommended that the FDA allow certain popular allergy medication to be sold without a prescription. The FDA may or may not accept the
recommendation of the advisory panel. If the FDA approves the sale of these allergy medications without prescription, our business may be adversely affected because royalty revenues may be reduced and
the market for prescription drugs, including SOLTARA brand tecastemizole, may be adversely affected.
WE WILL BE REQUIRED TO EXPEND SIGNIFICANT RESOURCES FOR RESEARCH, DEVELOPMENT, TESTING AND REGULATORY APPROVAL OF OUR DRUGS UNDER DEVELOPMENT AND THESE DRUGS MAY
NOT BE DEVELOPED SUCCESSFULLY.
We develop and commercialize proprietary products for the primary care and specialty markets. Most of our drug candidates are still undergoing
clinical trials or are in the early stages of development. Our ICE drugs may not provide greater benefits or fewer side effects than the original versions of these drugs and our research efforts may
not lead to the discovery of new drugs with benefits over existing treatments or development of new therapies. All of our drugs under development will require significant additional research,
development, preclinical and/or clinical testing, regulatory approval and a commitment of significant additional resources prior to their commercialization. Our potential products may not:
be
developed successfully;
be
proven safe and efficacious in clinical trials;
offer
therapeutic or other improvements over comparable drugs;
meet
applicable regulatory standards;
be
approved for commercialization by the FDA;
be
capable of being produced in commercial quantities at acceptable costs; or
be
successfully marketed.
IF SALES OF XOPENEX DO NOT CONTINUE TO INCREASE, WE WILL NOT HAVE SUFFICIENT REVENUES TO ACHIEVE OUR BUSINESS PLAN.
All of our revenue
from product sales and substantially all of our total revenue for the years ended December 31, 2000 and December 31, 2001, resulted from sales of XOPENEX. In March 2002, the FDA issued a
"not-approvable" letter for our next product SOLTARA 15 mg and 30 mg capsules. Accordingly, we expect that sales of XOPENEX will represent all of our product sales and the majority of
our total revenues for the next several years. If sales of XOPENEX do not continue to increase, we will not have sufficient revenues to achieve our business plan.
IF XOPENEX DOES NOT CONTINUE TO COMPETE SUCCESSFULLY AGAINST COMPETITIVE PRODUCTS, OUR BUSINESS WILL NOT BE SUCCESSFUL.
XOPENEX competes
primarily against
generic albuterol in the asthma market. XOPENEX is more expensive than generic albuterol. We must continue to demonstrate to physicians and other healthcare professionals that the benefits of XOPENEX
justify the higher price. If XOPENEX does not continue to compete successfully against competitive products, our business will not be successful.
IF WE FAIL TO ADEQUATELY PROTECT OUR INTELLECTUAL PROPERTY RIGHTS OR FACE A CLAIM OF INTELLECTUAL PROPERTY INFRINGEMENT BY A THIRD PARTY, THEN WE COULD LOSE
VALUABLE INTELLECTUAL PROPERTY RIGHTS, BE LIABLE FOR SIGNIFICANT DAMAGES OR BE PREVENTED FROM COMMERCIALIZING OUR PRODUCTS.
Our success depends in part on our ability to obtain
and maintain patents, protect trade secrets and operate without infringing upon the proprietary rights of others. In the absence of patent and trade secret protection, competitors may adversely affect
our business by independently developing and marketing substantially equivalent products and technology and preventing us from marketing our
18
products. It is also possible that we could incur substantial costs in litigation if we are required to defend ourselves in patent suits brought by third parties, or if we are required to initiate
litigation against others to protect our intellectual property rights.
We
have filed patent applications covering composition of, methods of making and methods of using, single isomer or active metabolite forms of various compounds for specific
applications. Our revenues under collaboration agreements with pharmaceutical companies depend in part on the existence and scope of issued patents. We may not be issued patents based on patent
applications already filed or that we file in the future and if patents are issued, they may be insufficient in scope to cover the products we seek to commercialize or products licensed under these
collaboration agreements. Moreover, the patent position of companies in the pharmaceutical industry generally involves complex legal and factual questions, and recently has been the subject of much
litigation. Legal standards relating to the scope and validity of patent claims are evolving. Any patents we have obtained, or obtain in the future, may be challenged, invalidated or circumvented.
Moreover, the United States Patent and Trademark Office, which we refer to as the PTO, may commence interference proceedings involving our patents or patent applications. Any challenge to, or
invalidation or circumvention of, our patents or patent applications would be costly, would require significant time and attention of our management and could have a material adverse effect on our
business.
Our
ability to commercialize any drug successfully will largely depend upon our ability to obtain and maintain patents of sufficient scope to prevent third parties from developing
similar or competitive products. Third parties, typically drug companies, hold patents or patent applications covering compositions, methods of making and uses, covering the composition of matter for
most of the drug candidates for which we have use or patent applications. Third parties also hold patents relating to drug delivery technology that may be necessary for the development or
commercialization of some of our drug candidates. In each of these cases, unless we have or obtain a license agreement, we generally may not commercialize the drug candidates until these third-party
patents expire or are declared invalid or unenforceable by the courts. Licenses may not be available to us on acceptable terms, if at all. In addition, it would be costly for us to contest the
validity of a third-party patent or defend any claim that we infringe a third-party patent. Moreover, litigation involving third-party patents may not be resolved in our favor. Such contests and
litigation would be costly, would require significant time and
attention of our management, could prevent us from commercializing our products, could require us to pay significant damages and could have a material adverse effect on our business.
IF OUR PRODUCTS DO NOT RECEIVE GOVERNMENT APPROVAL, THEN WE WILL NOT BE ABLE TO COMMERCIALIZE THEM.
The FDA and similar foreign agencies
must approve the marketing and sale of pharmaceutical products developed by us or our development partners. These agencies impose substantial requirements on the manufacture and marketing of drugs.
Any unanticipated preclinical and clinical studies we are required to undertake could result in a significant increase in the funds we will require to advance our products to commercialization. In
addition, the failure by us or our collaborative development partners to obtain regulatory approval on a timely basis, or at all, the attempt by us or our collaborative development partners to receive
regulatory approval to achieve labeling objectives, could prevent or adversely affect the timing of the commercial introduction of, or our ability to market and sell, our products. In
March 2002, we were informed by the FDA that it issued a "not-approvable" letter for our NDA for SOLTARA brand tecastemizole 15 mg and 30 mg capsules. While we had expected to launch SOLTARA in
the U.S. during 2002, we will not be able to commercialize SOLTARA unless and until we receive approval from the FDA and, currently, we do not expect to receive an approval, if at all, for at least
one year. In addition, in response to issues raised by the FDA regarding completeness of our NDA for eszopiclone, we are conducting additional preclinical studies to support use of RPR's preclinical
data package, including carcinogenicity studies. Assuming favorable results from ongoing studies, we anticipate submitting an NDA for eszopiclone to the FDA in 2002, which, if approved, we would
market under the name ESTORRA. Before we commercialize any of our product candidates, we will need to file NDAs, and the FDA will need to approve our NDAs. If
19
the FDA delays or denies approval of any NDA that we file in the future, then successful commercialization of our products under development may be delayed or terminated, which could have a material
adverse effect on our business.
The
regulatory process to obtain marketing approval requires clinical trials of a product to establish its safety and efficacy. Problems that may arise during clinical trials include:
results
of clinical trials may not be consistent with preclinical study results;
results
from later phases of clinical trials may not be consistent with the results from earlier phases; and
products
may not be shown to be safe and efficacious.
Even
if the FDA or similar foreign agencies grant us regulatory approval of a product, the approval may take longer than we anticipate and may be subject to limitations on the indicated
uses for which the product may be marketed or contain requirements for costly post-marketing follow-up studies.
Moreover, if we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating
restrictions and criminal prosecution.
THE DEVELOPMENT AND COMMERCIALIZATION OF OUR PRODUCTS AND PRODUCT CANDIDATES COULD BE DELAYED OR TERMINATED IF OUR COLLABORATION PARTNERS TERMINATE, OR FAIL TO
PERFORM THEIR OBLIGATIONS UNDER, THEIR AGREEMENTS WITH US OR IF ANY OF OUR COLLABORATION AGREEMENTS IS SUBJECT TO LENGTHY GOVERNMENT REVIEW.
We have entered into collaboration
arrangements with pharmaceutical companies. Our revenues under these collaboration arrangements will consist primarily of royalties on sales of products. Any such payments and royalties will depend in
large part on the development and commercialization efforts of our collaboration partners, which we cannot control. If any of our collaboration partners does not devote sufficient time and resources
to its collaboration arrangement with us, we may not realize the potential commercial benefits of the arrangement, and our results of operations may be adversely affected. In addition, if regulatory
approval of any product candidate under development by our collaboration partners is delayed or limited, we may not realize or may be delayed in realizing the potential commercial benefits of the
arrangement. If any of our collaboration partners were to breach or terminate its agreement with us or fail to perform its obligations to us in a timely manner, the development and commercialization
of the products could be delayed or terminated. Any failure or inability by us to perform, or any breach by us in our performance of, our obligations under a collaboration agreement could reduce or
extinguish the benefits to which we are otherwise entitled under the agreement. Any delay or termination of this type could have a material, adverse effect on our financial condition and results of
operations because we may be required to expend additional funds to bring our products to commercialization, we may lose technology rights and milestone or royalty payments from collaboration partners
or revenue from product sales, if any, could be delayed or terminated. We are entitled to receive royalties on sales, if any, of ticalopride under our agreement with Janssen. In April 2001,
Janssen announced that it had suspended clinical trials of ticalopride pending further analysis of a small number of adverse events reported in patients. We do not know if or when ticalopride may be
approved or the timing of commercialization of ticalopride.
Development
and commercialization of some of our product candidates may depend on our ability to enter into additional collaboration agreements with pharmaceutical companies to fund all
or part of the costs of development and commercialization of these product candidates. We may not be able to enter into collaboration agreements and the terms of the collaboration agreements, if any,
may not be favorable to us. The inability to enter into collaboration agreements could delay or preclude the development, manufacture and/or marketing of some of our drugs and could have a material
adverse effect on our financial condition and results of operations because:
we
may be required to expend additional funds to advance the drugs to commercialization;
20
revenue
from product sales could be delayed; or
we
may elect not to commercialize the drugs.
We
are required to file a notice under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, which we refer to as HSR Act, for certain agreements containing exclusive
license grants and to delay the effectiveness of any such exclusive license until the expiration or earlier termination of the notice and waiting period under the HSR Act. If the expiration or
termination of the notice and waiting period under the HSR Act is delayed because of lengthy government review, or if the Federal Trade Commission or Department of Justice successfully challenges such
a license, development and commercialization could be delayed or precluded and our business could be adversely affected.
WE HAVE LIMITED SALES AND MARKETING EXPERIENCE AND EXPECT TO INCUR SIGNIFICANT EXPENSES IN DEVELOPING A SALES FORCE. WE ALSO RELY ON THIRD PARTIES FOR SALES OF
OUR PRODUCTS. IN ADDITION, OUR LIMITED SALES AND MARKETING EXPERIENCE MAY RESTRICT OUR SUCCESS IN COMMERCIALIZING OUR PRODUCTS.
We currently have limited marketing and sales
experience. If we successfully develop and obtain regulatory approval for the products we are currently developing, we may license some of them to large pharmaceutical companies and market and sell
through our direct sales forces or through other arrangements, including co-promotion arrangements. We have established a direct sales force to market XOPENEX. We also expect to use a direct sales
force to market SOLTARA brand tecastemizole, if approved. As we begin to enter into co-promotion arrangements or market and sell additional products directly, we will need to significantly expand our
sales force. We expect to incur significant expense in expanding our direct sales force. With respect to products under development, we expect to incur significant costs in developing a sales force
before the products has been approved for marketing. Our limited experience in developing, maintaining and expanding a direct sales force may restrict our success in commercializing our products.
Our
ability to realize significant revenues from direct marketing and sales activities depends on our ability to attract and retain qualified sales personnel in the pharmaceutical
industry and competition for these persons is intense. If we are unable to attract and retain qualified sales personnel, we will not be able to successfully expand our marketing and direct sales force
on a timely or cost effective basis. We may also need to enter into additional co-promotion arrangements with third parties where our own direct sales force is neither well situated nor large enough
to achieve maximum penetration in the market. We may not be successful in entering into any co-promotion arrangements, and the terms of any co-promotion arrangements may not be favorable to us. We
depend in large part on a third-party contract sales organization for sales of XOPENEX and we may contract with third-party contract sales organizations in the future for other products, if
successfully developed and approved, including SOLTARA brand tecastemizole. We cannot control the level of effort and quality of service provided by co-promoters or any third party sales force. If the
level of effort and/or quality of service provided by these third parties are not adequate, our revenues would be adversely affected.
IF WE DO NOT MAINTAIN CURRENT GOOD MANUFACTURING PRACTICES, THEN THE FDA COULD REFUSE TO APPROVE MARKETING APPLICATIONS. WE DO NOT HAVE THE CAPABILITY TO
MANUFACTURE IN SUFFICIENT QUANTITIES ALL OF THE PRODUCTS WHICH MAY BE APPROVED FOR SALE, AND DEVELOPING AND OBTAINING THIS
CAPABILITY WILL BE TIME CONSUMING AND EXPENSIVE.
The FDA and other regulatory authorities require that our products be manufactured according to their good manufacturing
practices regulations. The failure by us, our collaborative development partners or third-party manufacturers to maintain current good manufacturing practices compliance and/or our failure to scale up
our manufacturing processes could lead to refusal by the FDA to approve marketing applications. Failure in either respect could also be the basis for action by the FDA to withdraw approvals previously
granted and for other regulatory action.
21
Failure to increase our manufacturing capabilities may mean that even if we develop promising new products, we may not be able to produce them. We currently operate a manufacturing plant
that is compliant with current good manufacturing practices that we believe can produce commercial quantities of the active pharmaceutical ingredient (API) for XOPENEX and support the production of
our other product candidates in amounts needed for our clinical trials. However, we will not have the capability to manufacture in sufficient quantities all of the products which may be approved for
sale. Accordingly, we will be required to spend money to expand our current manufacturing facility, build an additional manufacturing facility or contract the production of these drugs to third-party
manufacturers.
OUR RELIANCE ON A THIRD-PARTY MANUFACTURER COULD ADVERSELY AFFECT OUR ABILITY TO MEET OUR CUSTOMERS' DEMANDS.
Automatic Liquid Packaging,
a division of Cardinal Health, Inc., is currently the sole finished goods manufacturer of our product XOPENEX. If Automatic Liquid Packaging experiences delays or difficulties in producing,
packaging or delivering XOPENEX, we could be unable to meet our customers' demands for XOPENEX, which could lead to customer dissatisfaction and damage to our reputation. Furthermore, if we are
required to change manufacturers, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and
guidelines. The delays associated with the verification of a new manufacturer could negatively affect our ability to produce XOPENEX in a timely manner or within budget.
IF WE OR OUR COLLABORATION PARTNERS FAIL TO OBTAIN AN ADEQUATE LEVEL OF REIMBURSEMENT FOR OUR FUTURE PRODUCTS OR SERVICES BY THIRD PARTY PAYORS, THERE MAY BE NO
COMMERCIALLY VIABLE MARKETS FOR OUR PRODUCTS OR SERVICES.
The availability and amounts of reimbursement by governmental and other third party payors affects the market for any
pharmaceutical product or service. These third party payors continually attempt to contain or reduce the costs of healthcare by challenging the prices charged for medical products and services. In
certain foreign countries, including the countries of the EU, the pricing of prescription pharmaceuticals is subject to governmental control. We may not be able to sell our products profitably if
reimbursement is unavailable or limited in scope or amount.
In
both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system. Further proposals are
likely. The potential for adoption of these proposals affects or will affect our ability to raise capital, obtain additional collaboration partners and market our products. We expect to experience
pricing pressure for our existing products and any future products for which marketing approval is obtained due to the trend toward managed healthcare, the increasing influence of health maintenance
organizations and additional legislative proposals.
WE COULD BE EXPOSED TO SIGNIFICANT LIABILITY CLAIMS THAT COULD PREVENT OR INTERFERE WITH OUR PRODUCT COMMERCIALIZATION EFFORTS.
We may be
subjected to product liability claims that arise through the testing, manufacturing, marketing and sale of human health care products. These claims could expose us to significant liabilities that
could prevent or interfere with our product commercialization efforts. Product liability claims could require us to spend significant time and money in litigation or to pay significant damages.
Although we maintain product liability insurance coverage for both the clinical trials and commercialization of our products, it is possible that we will not be able to obtain further product
liability insurance on acceptable terms, if at all, and that our insurance coverage may not provide adequate coverage against all potential claims.
WE HAVE SIGNIFICANT LONG-TERM DEBT AND WE MAY NOT BE ABLE TO MAKE INTEREST OR PRINCIPAL PAYMENTS WHEN DUE. OUR EXCHANGES OF DEBT INTO SHARES OF COMMON STOCK COULD
RESULT IN ADDITIONAL DILUTION.
As of December 31, 2001, our total long-term debt was approximately $1,260.2 million and our stockholders' equity (deficit) was ($313.7)
million. In November and December 2001, we issued an aggregate of $500.0 million in
22
aggregate principal amount of 5.75% convertible subordinated notes with auto-conversion provision due 2006. None of the 7% convertible subordinated debentures due 2005, the 5% convertible
subordinated debentures due 2007, or the 5.75% notes due 2006 restricts our ability or our subsidiaries ability to incur additional indebtedness, including debt that ranks senior to the 7% debentures,
the 5% debentures, and the 5.75% notes. Additional indebtedness that we incur may rank senior to or on parity with these debentures and notes in certain circumstances. Our ability to satisfy our
obligations will depend upon our future performance, which is subject to many factors, including factors beyond our control. The conversion price for the 7% debentures is $62.4375, the conversion
price for the 5% debentures is $92.38 and the conversion price for the 5.75% notes is $60.00. If the market price for our common stock does not exceed the conversion price, the holders of the
debentures and notes may not convert their securities into common stock.
Historically,
we have had negative cash flow from operations. For the year ended December 31, 2001, net cash used in operating activities was approximately $208.4 million. The
annual debt service on our debentures and notes, assuming none of these securities is converted or redeemed, is approximately $72.8 million. Unless we are able to generate sufficient operating cash
flow to service the debentures and notes, we will be required to raise additional funds or default on our obligations under the debentures and notes. Based on our current operating plan, we believe
that we will not be required to raise additional capital to fund the repayment of our outstanding convertible debt when due. However, if we are not able to commercialize our current late-stage product
candidates, including both SOLTARA and ESTORRA, or if such product candidates, if approved, do not achieve expected sales levels, we may be required to raise additional funds in order to repay our
outstanding convertible debt and there can be no assurance that, if required, we would be able to raise such funds on favorable terms, if at all.
Our
7% debentures, 5% debentures and 5.75% notes are currently trading at discounts to their respective face amounts. Accordingly, in order to reduce future cash interest payments, as
well as future amounts due at maturity, we have, subsequent to December 31, 2001 and through March 27, 2002,
exchanged, in privately negotiated transactions, approximately $97.0 million of our convertible subordinated debt, for approximately 3,541,000 shares of our common stock. We, may from time to
time, depending on market conditions, exchange shares of our common stock for additional outstanding convertible subordinated debt, and the number of shares that we might issue as a result of such
exchanges would significantly exceed the number of shares originally issuable upon conversion of such debt. Accordingly, such exchanges could result in material dilution to holders of our common
stock. There can be no assurance that we will exchange any or all of our outstanding convertible subordinated debt for shares of our common stock.
IF SUFFICIENT FUNDS TO FINANCE OUR BUSINESS ARE NOT AVAILABLE TO US WHEN NEEDED OR ON ACCEPTABLE TERMS, THEN WE MAY BE REQUIRED TO DELAY, SCALE BACK, ELIMINATE OR
ALTER OUR STRATEGY FOR OUR PROGRAMS.
We may require additional funds for our research and product development programs, operating expenses, the pursuit of regulatory approvals,
license or acquisition opportunities and the expansion of our production, sales and marketing capabilities. Historically, we have satisfied our funding needs through collaboration arrangements with
corporate partners and equity and debt financings. These funding sources may not be available to us when needed in the future, and, if available, they may not be on terms acceptable to us.
Insufficient funds could require us to delay, scale back or eliminate certain of our research and product development programs or to license third parties to commercialize products or technologies
that we would otherwise develop or commercialize ourselves. Our cash requirements may vary materially from those now planned because of factors including:
patent
developments;
licensing
or acquisition opportunities;
23
relationships
with collaboration partners;
the
FDA regulatory process;
our
capital requirements; and
selling,
marketing and manufacturing expenses in connection with commercialization of products.
WE EXPECT TO FACE INTENSE COMPETITION AND OUR COMPETITORS HAVE GREATER RESOURCES AND CAPABILITIES THAN WE HAVE. DEVELOPMENTS BY OTHERS MAY RENDER OUR PRODUCTS OR
TECHNOLOGIES OBSOLETE OR NONCOMPETITIVE.
We expect to encounter intense competition in the sale of our current and future products. If we are unable to compete effectively, our
financial condition and results of operations could be materially adversely affected because we may use our financial resources to seek to differentiate ourselves from our competition and because we
may not achieve our product revenue objectives. Many of our competitors and potential competitors, which include pharmaceutical companies, biotechnology firms, universities and other research
institutions, have substantially greater resources, manufacturing and marketing capabilities, research and development staff and production facilities than we have. The fields in which we compete are
subject to rapid and substantial technological change. Our competitors may be able to respond more quickly to new or emerging technologies or to devote greater resources to the development,
manufacture and marketing of new products and/or technologies than we can. As a result, any products and/or technologies that we develop may become obsolete or noncompetitive before we can recover
expenses incurred in connection with their development.
FLUCTUATIONS IN THE DEMAND FOR PRODUCTS, THE SUCCESS AND TIMING OF COLLABORATION ARRANGEMENTS AND REGULATORY APPROVAL, ANY TERMINATION OF DEVELOPMENT EFFORTS,
EXPENSES AND THE RESULTS OF OPERATIONS OF OUR SUBSIDIARIES WILL CAUSE FLUCTUATIONS IN OUR QUARTERLY OPERATING RESULTS, WHICH COULD CAUSE VOLATILITY IN OUR STOCK PRICE.
Our
quarterly operating results are likely to fluctuate significantly, which could cause our stock price to be volatile. These fluctuations will depend on factors, which include:
the
success and timing of regulatory filings and approvals for products developed by us or our collaboration partners or for collaborative agreements;
the
success and timing of collaboration agreements for development of our pharmaceutical candidates and development costs for those pharmaceuticals;
the
termination of development efforts of any product under development or any collaboration agreement;
the
timing of receipt of upfront, milestone or royalty payments under collaboration agreements;
the
timing of product sales and market penetration;
the
timing of operating expenses, including selling and marketing expenses and the costs of expanding and maintaining a direct sales force; and
the
timing of expenses we may incur with respect to any license or acquisitions of products or technologies.
OUR STOCK PRICE COULD BE HIGHLY VOLATILE, WHICH COULD CAUSE YOU TO LOSE PART OR ALL OF YOUR INVESTMENT.
The market price of our common
stock, like that of the common stock of many other pharmaceutical and biotechnology companies, may be highly volatile. In addition, the stock market has experienced extreme price and volume
fluctuations. This volatility has significantly affected the market prices of securities of many pharmaceutical and biotechnology companies for reasons frequently unrelated to or disproportionate to
the operating performance of the
24
specific companies. These broad market fluctuations may adversely affect the market price of our common stock. Prices for our common stock will be determined in the market place and may be influenced
by many factors, including variations in our financial results and investors' perceptions of us, changes in recommendations by securities analysts as well as their perceptions of general economic,
industry and market conditions.
Supplemental Stockholder Information
Price Range of Common Stock
The Sepracor common stock is traded on the NASDAQ National Market under the symbol SEPR. On March 13, 2002, the closing price of the Company's common
stock, as reported on the NASDAQ National Market, was $21.29 per share. The following table sets forth for the periods indicated the high and low sales prices per share of the common stock as reported
by the NASDAQ National Market. The share prices set forth below have been adjusted to reflect the two-for-one stock split of the Company's common stock effected on February 25, 2000.
High
Low
2002
First Quarter (through March 13, 2002)
$
57.25
$
17.15
High
Low
2001
First Quarter
81.88
24.81
Second Quarter
46.20
23.45
Third Quarter
46.28
30.00
Fourth Quarter
60.05
35.09
High
Low
2000
First Quarter
126.81
45.06
Second Quarter
125.00
57.75
Third Quarter
140.00
90.50
Fourth Quarter
124.81
61.50
On
March 13, 2002, Sepracor had approximately 492 stockholders of record.
Dividend Policy
Sepracor has never paid cash dividends on its common stock. The Company currently intends to reinvest its future earnings, if any, for use in the business and
does not expect to pay cash dividends.
Form 10-K
A copy of the Company's Annual Report on Form 10-K for the year ended December 31, 2001 is available without charge upon written request
to:
INVESTOR RELATIONS
SEPRACOR INC.
111 LOCKE DRIVE
MARLBOROUGH, MA 01752
25
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors of Sepracor Inc.
In
our opinion, based upon our audits and the report of other auditors, the accompanying consolidated balance sheets and the related consolidated statements of operations, of
stockholders' equity (deficit) and comprehensive income, and of cash flows present fairly, in all material respects, the financial position of Sepracor Inc. and its subsidiaries (the "Company") at
December 31, 2001 and 2000, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2001, in conformity with accounting
principles generally accepted in the United States of America. These financial statements are the responsibility of the Company's management; our responsibility is to express an opinion on these
financial statements based on our audits. We did not audit the financial statements of BioSphere Medical Inc., a majority-owned subsidiary through July 2, 2001, which statements reflect total
assets of 3% of the related consolidated totals as of December 31, 2000, and total revenues of 5% and 10% of the related consolidated totals for each of the two years in the period ended
December 31, 2000. Those statements were audited by other auditors whose report thereon has been furnished to us, and our opinion expressed herein, insofar as it relates to the amounts included
for BioSphere Medical Inc. through December 31, 2000, is based solely on the report of the other auditors. We conducted our audits of these statements in accordance with auditing standards
generally accepted in the United States of America which require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant
estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits and the report of other auditors provide a reasonable basis for our opinion.
/s/
PricewaterhouseCoopers LLP
PricewaterhouseCoopers
LLP
Boston, Massachusetts
January 21, 2002, except as to the information in
Note V for which the date is March 27, 2002
26
SEPRACOR INC.
CONSOLIDATED BALANCE SHEETS
December 31,
(In Thousands, Except Par Value Amounts)
2001
2000
ASSETS
Current assets:
Cash and cash equivalents
$
715,082
$
354,058
Short-term investments
116,063
248,818
Accounts receivable, net of allowances of $585 and $378 at December 31, 2001 and 2000
21,660
14,756
Inventories
9,773
5,998
Other assets
10,395
5,212
Total current assets
872,973
628,842
Long-term investments
73,244
31,603
Property and equipment, net
43,846
22,676
Investment in affiliates
43,089
13,746
Patents, intangible assets and other assets, net
60,379
54,091
Total assets
$
1,093,531
$
750,958
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
Current liabilities:
Accounts payable
$
25,091
$
30,665
Accrued expenses
102,598
65,560
Notes payable and current portion of capital lease obligation and long-term debt
624
144
Other current liabilities
17,524
7,810
Total current liabilities
145,837
104,179
Long-term debt and capital lease obligation
1,436
1,098
Convertible subordinated debt
1,259,960
852,818
Other long-term liabilities
478
Total liabilities
1,407,233
958,573
Minority interest
7,059
Commitments and contingencies (Notes M and N)
Stockholders' equity (deficit)
Preferred stock, $1.00 par value, 1,000 shares authorized, none outstanding at December 31, 2001 and 2000
Common stock, $.10 par value, 240,000 and 240,000 shares authorized; 78,059 and 73,829 shares issued and outstanding, at December 31, 2001 and 2000, respectively
7,806
7,383
Additional paid-in capital
562,341
461,195
Unearned compensation, net
(120
)
(189
)
Accumulated deficit
(917,402
)
(693,387
)
Accumulated other comprehensive income
33,673
10,324
Total stockholders' equity (deficit)
(313,702
)
(214,674
)
Total liabilities and stockholders' equity (deficit)
$
1,093,531
$
750,958
The
accompanying notes are an integral part of the consolidated financial statements.
27
SEPRACOR INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Year Ended December 31,
(In Thousands, Except Loss Per Common Share Amounts)
2001
2000
1999
Revenues:
Product sales
$
125,248
$
57,160
$
16,383
Royalties
25,663
2,573
2,000
License fees and other
1,184
21,939
1,886
Collaborative research and development
3,573
2,390
Total revenues
152,095
85,245
22,659
Costs and expenses:
Cost of products sold
15,411
11,278
4,811
Cost of license fees and other
493
3,056
108
Research and development
231,278
170,759
122,400
Selling, marketing and distribution
111,654
77,410
48,211
General and administrative and patent costs
19,732
20,988
17,125
Total costs and expenses
378,568
283,491
192,655
Loss from operations
(226,473
)
(198,246
)
(169,996
)
Other income (expense):
Interest income
25,669
41,919
21,896
Interest expense
(47,793
)
(47,760
)
(33,078
)
Equity in investee gains (losses)
(1,601
)
3,501
(3,246
)
Other income (expense)
997
(7,051
)
272
Gain on sale of BioSphere stock
23,034
Net loss before minority interest
(226,167
)
(207,637
)
(184,152
)
Minority interest in subsidiaries
2,152
3,620
1,438
Net loss from continuing operations
(224,015
)
(204,017
)
(182,714
)
Discontinued operations:
Loss from discontinued operations (net of minority interest)
(345
)
Net loss
$
(224,015
)
$
(204,017
)
$
(183,059
)
Basic and diluted net loss per common share from continuing operations
$
(2.89
)
$
(2.80
)
$
(2.77
)
Basic and diluted net loss per common share from discontinued operations
$
(0.00
)
Basic and diluted net loss per common share
$
(2.89
)
$
(2.80
)
$
(2.77
)
Shares used in computing basic and diluted net loss per common share:
Basic and diluted
77,534
72,757
66,049
The
accompanying notes are an integral part of the consolidated financial statements.
28
SEPRACOR INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) AND COMPREHENSIVE INCOME
Common Stock
Accumulated
Other
Comprehensive
Income (Loss)
Total
Stockholder's
Equity
(Deficit)
Years Ended December 31, 2001,
2000, and 1999 (In Thousands)
Additional
Paid-in
Capital
Unearned
Compensation
Accumulated
Deficit
Shares
Amount
BALANCE AT DECEMBER 31, 1998
65,313
$
6,531
$
304,403
$
(144
)
$
(306,311
)
$
(51
)
$
4,428
Comprehensive income (loss):
Net loss
(183,059
)
(183,059
)
Foreign currency translation
(406
)
(406
)
Total comprehensive income (loss)
(183,465
)
Issuance of common stock to employees under stock plans
1,968
197
12,813
13,010
Unearned compensation, net
129
(73
)
56
Compensation expense
419
419
Issuance of common stock for purchase of intangible technology
200
20
7,930
7,950
Gain on issuance of subsidiary's stock
1,897
1,897
BALANCE AT DECEMBER 31, 1999
67,481
$
6,748
$
327,591
$
(217
)
$
(489,370
)
$
(457
)
$
(155,705
)
Comprehensive income (loss):
Net loss
(204,017
)
(204,017
)
Foreign currency translation
33
33
Unrealized gain on marketable equity securities
10,748
10,748
Total comprehensive income (loss)
(193,236
)
Issuance of common stock to employees under stock plans
2,268
227
33,600
33,827
Unearned compensation, net
40
28
68
Issuance of common stock from conversion of subordinated convertible debentures
4,080
408
408
Conversion of debentures
96,249
96,249
Deferred finance costs from the conversion of subordinated convertible debentures
(2,373
)
(2,373
)
BioSphere issuance of common stock
18,274
18,274
Sepracor investment in BioSphere
(5,000
)
(5,000
)
Minority interest in proceeds of BioSphere common stock
(9,864
)
(9,864
)
BioSphere deferred compensation
1,261
1,261
Gain on issuance of HemaSure stock (net)
1,417
1,417
BALANCE AT DECEMBER 31, 2000
73,829
$
7,383
$
461,195
$
(189
)
$
(693,387
)
$
10,324
$
(214,674
)
Comprehensive income (loss):
Net loss
(224,015
)
(224,015
)
Foreign currency translation
497
497
Unrealized gain on marketable equity securities
22,852
22,852
Total comprehensive income (loss)
(200,666
)
Issuance of common stock to employees under stock plans
309
31
4,661
4,692
Unearned compensation, net
69
69
Issuance of common stock from conversion of subordinated convertible debentures
3,921
392
92,466
92,858
Deferred finance costs from the conversion of subordinated convertible debentures
(1,525
)
(1,525
)
Net of Biosphere investment, loss, minority interest and deconsolidation
5,544
5,544
BALANCE AT DECEMBER 31, 2001
78,059
$
7,806
$
562,341
$
(120
)
$
(917,402
)
$
33,673
$
(313,702
)
The
accompanying notes are an integral part of the consolidated financial statements.
29
SEPRACOR INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31,
(In Thousands)
2001
2000
1999
Cash flows from operating activities:
Net loss
$
(224,015
)
$
(204,017
)
$
(183,059
)
Less: Net loss from discontinued operations (net of minority interest)
(345
)
Net loss from continuing operations
(224,015
)
(204,017
)
(182,714
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
13,048
11,536
7,522
Gain on sale of BioSphere stock
(23,034
)
Minority interests in subsidiaries
(2,152
)
(3,620
)
(1,438
)
Equity in investee (gains) losses
1,601
(3,501
)
3,246
Provision for bad debt
145
51
165
Loss on disposal of property and equipment
287
25
6
Stock compensation
1,261
419
Changes in operating assets and liabilities:
Accounts receivable
(8,718
)
(10,565
)
(3,883
)
Inventories
(4,581
)
(1,543
)
(4,061
)
Other current assets
(5,425
)
243
(4,007
)
Accounts payable
(4,491
)
10,469
10,535
Accrued expenses
38,844
22,985
11,095
Other current liabilities
10,072
5,733
(424
)
Net cash used in operating activities
(208,419
)
(170,943
)
(163,539
)
Cash flows from investing activities:
Purchases of short and long-term investments
(535,761
)
(936,914
)
(478,517
)
Sales and maturities of short and long-term investments
626,839
932,888
406,456
Additions to property and equipment
(28,688
)
(8,837
)
(6,968
)
Purchase of intangible assets
(12,500
)
(10,000
)
Net proceeds from sale of BioSphere stock
26,526
Deconsolidation of BioSphere cash
(9,405
)
Investment in subsidiary and affiliates
(5,950
)
(3,000
)
Cash acquired in acquisition of BioSphere SA
283
Other assets
(2,111
)
(1,261
)
1,569
Net cash provided by (used in) investing activities
77,400
(32,574
)
(90,177
)
Cash flows from financing activities:
Net proceeds from issuance of common stock
4,701
52,101
13,010
Proceeds from sale of convertible subordinated debt
500,000
460,000
Costs associated with sale of convertible subordinated debt
(13,982
)
(14,033
)
(276
)
Repayments of long-term debt, capital leases and line of credit agreements
(532
)
(151
)
(4,090
)
Borrowings of long-term debt, capital leases and line of credit agreements
1,475
137
Net cash provided by financing activities
491,662
498,054
8,644
Effect of exchange rate changes on cash and cash equivalents
381
33
(406
)
Net increase (decrease) in cash and cash equivalents
361,024
294,570
(245,478
)
Net cash provided by discontinued operations
9,643
Cash and cash equivalents at beginning of year
354,058
59,488
295,323
Cash and cash equivalents at end of year
$
715,082
$
354,058
$
59,488
Supplemental schedule of cash flow information:
Cash paid during the year for interest
$
46,899
$
41,390
$
33,014
Non cash activities:
Conversion of convertible subordinated debt
$
92,858
$
94,284
$
Common stock issued for intangible asset
$
$
$
(7,950
)
BioSphere acquisition of BioSphere Medical:
Liabilities assumed
$
$
$
(1,493
)
Fair value of assets acquired
$
$
$
1,493
The
accompanying notes are an integral part of the consolidated financial statements.
30
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
A) Nature of the Business
Sepracor Inc. was incorporated in 1984 to research, develop and commercialize products for the synthesis, separation and purification of pharmaceutical and
biopharmaceutical compounds. Sepracor Inc. is a research-based pharmaceutical company dedicated to treating and preventing human disease through the discovery, development, and commercialization of
innovative pharmaceutical compounds, including product candidates directed toward serving unmet medical needs. Sepracor's drug development program has yielded an extensive portfolio of pharmaceutical
compounds that are focused on the treatment of respiratory, urology, and central nervous system disorders. Sepracor's corporate headquarters are located in Marlborough, Massachusetts. Sepracor's 100%
owned subsidiary, Sepracor Canada Ltd., supplies clinical material to Sepracor through its manufacturing facility in Windsor, Nova Scotia. Sepracor's approximately 25% equity investment in BioSphere
Medical Inc. (which was majority owned through July 2, 2001) with operations in France and the United States, is committed to pioneering the use of patented and proprietary bioengineered
microspheres as a new class of embolotherapy medical devices.
Sepracor
and its subsidiaries are subject to risks common to companies in the industry including, but not limited to, the safety, efficacy and successful development and regulatory
approval of product candidates, fluctuations in operating results, protection of proprietary technology, limited sales and marketing experience, dependence on third party collaboration agreements and
third party sales efforts, limited manufacturing capacity, risk of product liability, compliance with government regulations and dependence on key personnel and collaborative partners.
B) Summary of Significant Accounting Policies
Principles of Consolidation:
Consolidated financial statements include the accounts of Sepracor and all of its
wholly- and majority-owned subsidiaries. All material intercompany transactions have been eliminated. Investments in affiliated companies, which are 50% owned or less, and where Sepracor does not
exercise control, are accounted for using the equity method.
The
Company accounts for the sale of subsidiary stock in different manners, depending on the life cycle of the entity. The Company offsets any gains or losses against additional paid-in
capital for early development stage subsidiaries. For later stage subsidiaries where the Company sells shares of its subsidiary's stock, the Company records its gains and losses as other income or
expense. For later stage
subsidiaries selling additional shares of the subsidiary's stock, the Company records its gains or losses through additional paid-in capital.
Use of Estimates and Assumptions in the Preparation of Financial Statements:
The preparation of financial statements in conformity with
generally accepted accounting principles requires management to make estimates and assumptions that affect the following: (1) the reported amounts of assets and liabilities, (2) the disclosure
of contingent assets and liabilities at the dates of the financial statements and (3) the reported amounts of revenues and expenses during the reporting periods. Actual results could differ
from those estimates.
Reclassifications in the Preparation of Financial Statements:
All references to share and per-share data for all periods presented have
been adjusted to give effect for the two-for-one stock split effected in February 2000. Certain prior amounts have been reclassified to conform with current year presentation.
Translation of Foreign Currencies:
The assets and liabilities of Sepracor's international subsidiaries are translated into U.S. dollars
using current exchange rates. Statement of operations amounts are translated at average exchange rates prevailing during the period. The resulting translation adjustment
31
is recorded in accumulated other comprehensive income (loss). Foreign exchange transaction gains and losses are included in other income (expense).
Cash and Cash Equivalents:
Cash equivalents are highly liquid, temporary cash investments having original maturity dates of three months
or less.
Short and Long-Term Investments:
Short and long-term investments include government securities and corporate commercial paper, which can
be readily purchased or sold using established markets. Those investments with a maturity of less than one year are classified as short-term. Short and long-term investments are classified as either
"available-for-sale" or "held-to-maturity". Available-for-sale investments are adjusted to their fair market value with unrealized gains and losses recorded as a component of accumulated other
comprehensive income (loss). Realized gains and losses for securities classified as available-for-sale are included in earnings and are derived using the specific identification method for determining
the cost of securities sold. Held-to-maturity investments are recorded at cost plus accrued amortization, which approximates fair value.
Concentration of Credit Risk:
The Company has no significant off balance sheet concentration of credit risk such as foreign exchange
contracts, option contracts or other foreign hedging arrangements. The Company maintains the majority of its cash balances with financial institutions. Financial instruments that potentially subject
the Company to concentrations of credit risk primarily consist of the cash and cash equivalents, short and long-term investments and trade accounts receivable. The Company places
its cash, cash equivalents and short-term and long-term investments with high credit quality financial institutions.
Revenues
from significant customers are as follows:
Year Ended December 31,
2001
2000
1999
Customer A
17
%
16
%
15
%
Customer B
15
%
9
%
11
%
Customer C
17
%
3
%
16
%
Customer D
12
%
9
%
11
%
Customer E
28
%
Accounts Receivable and Bad Debt:
Sepracor's trade receivables in 2001 and 2000 primarily represent amounts due to the Company from
wholesalers, distributors and retailers of its pharmaceutical product. Sepracor performs ongoing credit evaluations of its customers and generally does not require collateral. Bad debt write-offs were
not significant in 2001, 2000 and 1999; however the Company monitors its receivables closely due to few customers making up a large portion of the overall revenues.
Inventories:
Inventories are stated at the lower of cost (first-in, first-out) or market. When the commercialization of a new product
becomes probable, it is then capitalized. The Company writes down its inventory for expiry and probable quality assurance and quality control issues identified in the manufacturing process.
Property and Equipment:
Property and equipment are stated at cost. Costs of major additions and betterments are capitalized; maintenance
and repairs, which do not improve or extend the life of the respective assets are charged to operations. On disposal, the related cost and accumulated depreciation or amortization are removed from the
accounts and any resulting gain or loss is included in the results of operations. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. All laboratory,
manufacturing and office equipment have estimated useful lives of three to ten years. The building has an estimated useful life of thirty years. Leasehold improvements are amortized over the shorter
of the estimated useful lives of the improvements or the remaining term of
32
the lease. The Company has determined that in substance, under EITF 97-10, it is the owner of the building asset under construction and therefore has capitalized construction costs as construction in
progress on the balance sheet.
Patents, Intangible Assets and Other Assets:
Sepracor capitalizes significant costs associated with the filing of a patent application.
Patent costs are amortized over their estimated useful lives, not to exceed 17 years. Deferred finance costs relating to expenses incurred to complete convertible subordinated debt offerings are
amortized over five to seven years, the term of the debt. Capitalized license fees are amortized over the expected life of the licenses. Accumulated amortization was $6,849,000 and $6,317,000 at
December 31, 2001 and 2000, respectively. Long-lived assets are reviewed for impairment by comparing the undiscounted projected cash flows of the related assets with their carrying amount. Any
write-downs are treated as permanent reductions in the carrying amount of the assets.
The
Company currently has long-lived assets relating to patents on drugs in late stages of clinical development but not yet approved. If these drugs fail to receive final FDA approval
the Company could potentially have material write-downs of assets.
Revenue Recognition:
Sepracor recognizes revenue from product sales when title to product and associated risk of loss has passed to the
customer, and collectability is reasonably assured. All revenues from product sales are recorded net of applicable allowances for returns, rebates, and other applicable discounts and allowances.
Sepracor
receives royalties related to the manufacture, sale or use of products or technologies under license arrangements with third parties. For those arrangements where royalties are
reasonably estimable, Sepracor recognizes revenue based on estimates of royalties earned during the applicable period and adjusts for differences between the estimated and actual royalties in the
following quarter. Historically, these adjustments have not been material. For those arrangements where royalties are not reasonably estimable, Sepracor recognizes revenue upon receipt of royalty
statements from the licensee.
License
fees and other revenue include non-refundable upfront license fees, milestones, and other revenues. Non-refundable upfront license fees are recorded as
revenue over the related performance period or at such time when there are no remaining performance obligations. Milestones are recorded as revenue when achieved and only if there are no remaining
performance obligations and the fees are
non-refundable. Other revenue includes revenues recognized by BioSphere unrelated to its core EmboSphere Microsphere business.
Sepracor
records collaborative research and development revenue from research and development contracts over the term of the applicable contract, as it incurs costs related to the
contract.
Rebate and Return Reserves:
Certain product sales qualify for rebates from standard list pricing due to government sponsored programs or
other contractual agreements. The Company also allows for return of its product for up to one year after product expiration. Reserves for product returns and rebates are derived through an analysis of
historical experience updated for changes in facts and circumstances as appropriate and by utilizing reports obtained from external, independent sources. If government contracts change materially, the
associated reserves estimated for those programs can change significantly. Estimates of reserves for returns are impacted by the extended return cycle, and by other factors such as introduction of a
new competitive product, or other change in market conditions leading to a change in historical return patterns.
Research and Development:
All costs associated with internal research and development, research and development conducted for others and
research and development services for which the Company has been contracted are expensed as incurred.
Income Taxes:
The Company recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been
included in the financial statements or tax returns. Under
33
this method, deferred tax liabilities and assets are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for
the year in which the differences are expected to reverse.
Derivatives:
In June 2000, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standard
("SFAS") No. 138, "Accounting for Certain Derivative Instruments and Certain Hedging Activities"An Amendment to "FASB Statement No. 133." This statement establishes
accounting and reporting standards for derivative instruments embedded in other contracts (collectively referred to as "derivatives") and for hedging activities. The statement requires companies to
recognize all derivatives as either assets or liabilities, with the instruments measured at fair value. The accounting for changes in fair value, and resulting gains or losses, depends on the intended
use of the derivative and its resulting designation. The Company adopted this new accounting standard effective January 1, 2001 and the impact of adoption was not material.
Comprehensive Income (Loss):
Comprehensive income (loss) consists of net income (loss) and other comprehensive income (loss), which
includes foreign currency translation adjustments and unrealized gains and losses on available-for-sale investments.
Basic and Diluted Net Loss Per Common Share:
Basic earnings (loss) per share ("EPS") excludes dilution and is computed by dividing income
available to common shareholders by the weighted-average number of common shares outstanding for the period. Diluted EPS is based upon the weighted-average number of common shares outstanding during
the period plus the additional weighted average common equivalent shares during the period. Common equivalent shares are not included in the per share calculations where the effect of their inclusion
would be anti-dilutive. Common equivalent shares result from the assumed conversion of preferred stock, convertible subordinated debt and the assumed exercises of outstanding stock options, the
proceeds of which are then assumed to have been used to repurchase outstanding stock options using the treasury stock method.
For
the years ended December 31, 2001, 2000 and 1999, basic and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding
during the period because the effect of common stock equivalents would be anti-dilutive. Certain securities were not included in the computation of diluted earnings per share for the years ended
December 31, 2001, 2000 and 1999 because they would have an anti-dilutive effect due to net losses for such periods. These securities include the following:
Options
to purchase shares of common stock:
(In Thousands, Except Price Per Share Data)
2001
2000
1999
Number of options
11,915
9,757
10,940
Price range per share
$
2.50 to $125.44
$
2.50 to $125.44
$
0.75 to $59.13
Shares
of common stock reserved for issuance upon conversion of convertible subordinated debt:
(In Thousands)
2001
2000
1999
6.25% convertible subordinated debentures due 2005
3,921
8,000
7% convertible subordinated debentures due 2005
4,804
4,804
4,805
5% convertible subordinated debentures due 2007
4,979
4,979
5.75% convertible subordinated notes due 2006
8,333
18,116
13,704
12,805
34
Other:
In June 2001, the Financial Accounting Standards Board, or FASB, issued Statement of Financial Accounting Standards, or SFAS No. 141, "Business
Combinations" and SFAS No. 142, "Goodwill and Other Intangible Assets." SFAS No. 141 requires that all business combinations be accounted for under the purchase method and that certain acquired
intangible assets in a business combination be recognized as assets apart from goodwill. SFAS No. 142 requires that ratable amortization of goodwill and certain intangible assets be replaced
with periodic tests of the goodwill's impairment and that intangible assets be amortized over their useful lives. SFAS No. 141 is effective for all business combinations initiated after
June 30, 2001 and for all business combinations accounted for by the purchase method for which the date of acquisition is after June 30, 2001. The provisions of SFAS No. 142 will
be effective for fiscal years beginning after December 15, 2001, and will thus be adopted by us in fiscal year 2002. However, for goodwill and intangible assets acquired after June 30,
2001, certain provisions of SFAS No. 142 will be effective from the date of acquisition. The Company notes that SFAS No. 141 does not currently have any effect on the reported financial results
and does not expect the adoption of SFAS No. 142 to have a material impact on the Company's financial statements and related disclosures
In
June 2001, the FASB issued SFAS No. 143, "Accounting for Asset Retirement Obligations." This statement addresses financial accounting and reporting for obligations
associated with the retirement of tangible long-lived assets and the associated asset retirement costs. This statement applies to all entities. It applies to legal obligations associated with the
retirement of long-lived assets that result from the acquisition, construction, development and/or the normal operation of a long-lived asset, except for certain obligations of lessees. This statement
is effective for financial statements issued for fiscal years beginning after June 15, 2002. The Company does not believe that the adoption of this standard will have a material impact on the
Company's financial statements and related disclosures.
In
August 2001, the FASB issued SFAS No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets," which supercedes SFAS No. 121, "Accounting for the
Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of." SFAS No. 144 further refines the requirements of SFAS No. 121 that companies (1) recognize an
impairment loss only if the carrying amount of a long-lived asset is not recoverable based on its undiscounted future cash flows and (2) measure an impairment loss as the difference between the
carrying amount and fair value of the asset. In addition, SFAS No. 144 provides guidance on accounting and disclosure issues surrounding long-lived assets to be disposed of by sale. The Company
will adopt SFAS No. 144 during the first quarter of 2002 and does not believe that the adoption of this standard will have a material impact on the Company's financial statements and related
disclosures.
C) Sepracor Investments in Affiliates
Investment in Biosphere:
BioSphere was a consolidated subsidiary of Sepracor from 1994 through July 2, 2002. In May 1999, BioSphere sold a substantial portion of its business and assets
to complete a transition from a chromatography and media company to a medical device company. (See Note IDiscontinued Operations.)
In
February 2000, BioSphere completed a private placement of approximately $5,900,000 of BioSphere common stock and warrants. Investors purchased 653,887 shares of BioSphere
common stock and warrants to purchase 163,468 shares of BioSphere common stock. The transaction resulted in Sepracor recording a net gain of approximately $2,771,000 through additional paid-in
capital.
In
July 2000, BioSphere sold approximately $13,000,000 of its common stock in a private equity placement of its common stock. Sepracor purchased approximately $5,000,000 of
BioSphere common
35
stock in this transaction. The transaction resulted in Sepracor recording a net gain of approximately $1,702,000 through additional paid-in capital.
In
July 2001, Sepracor sold 2,000,000 shares of BioSphere common stock held by it in a public offering in which BioSphere also sold 2,000,000 shares of its common stock at a price
to the public of $11.00 per share. On August 2, 2001, the underwriters exercised their over-allotment option to purchase an additional 600,000 shares of BioSphere common stock from Sepracor at
a price to the public of $11.00 per share. Sepracor received net proceeds, after offering costs, from the sales of approximately $26,526,000 and has recognized a gain of approximately $23,034,000 in
2001. Sepracor recorded approximately $5,590,000 through additional paid-in capital as its gain on BioSphere's sale of 2,000,000 shares of BioSphere common stock. As a result of the public offering,
Sepracor's ownership in BioSphere has been reduced from approximately 55% to 25% as of December 31, 2001. Sepracor no longer consolidates the results of BioSphere and now records its investment
in BioSphere under the equity method, effective July 3, 2001. Sepracor has recorded $1,601,000 as its share of BioSphere losses for the period ended December 31, 2001.
Investment in HMSR, Inc (Formerly Hemasure, Inc):
HemaSure has been an equity investment of Sepracor since 1995. In February 1999, the Company entered into an agreement with HemaSure pursuant to which Sepracor
invested $2,000,000 in exchange for 1,333,334 shares of HemaSure common stock and warrants to purchase approximately 667,000 of additional shares of HemaSure common stock. In October 1999,
HemaSure completed a private placement financing which resulted in Sepracor recording a gain of $820,000, which was recorded through additional paid-in capital. At December 31, 1999, Sepracor's
ownership of HemaSure was approximately 27%.
In
March 2000, HemaSure sold 3,730,000 shares of common stock in a private placement, thereby reducing Sepracor ownership to approximately 22%. Sepracor recorded a gain of
approximately $1,417,000 through additional paid-in capital as a result of the transaction. Sepracor accounts for its investment in HemaSure using the equity method of accounting. At
December 31, 2001 and 2000, Sepracor's ownership in HemaSure was approximately 23% and 22%, respectively and its investment in HemaSure was recorded at zero.
In
February 2001, HemaSure signed an asset purchase agreement with Whatman plc. Under the terms of the agreement, Whatman agreed to purchase HemaSure's assets, except for cash,
cash equivalents and marketable securities of HemaSure, subject to certain exceptions as defined in the agreement. On May 29, 2001, HemaSure completed the sale to Whatman Bioscience Inc., a
Massachusetts corporation and a subsidiary of Whatman plc. Following the sale, HemaSure changed it corporate name to HMSR, Inc.
In
November 2001, HMSR, Inc. announced that it had signed a definitive agreement to merge with Point Therapeutics, Inc. Following the merger, HMSR's current
stockholders will own approximately 23% of the combined company.
Investment in Versicor:
Versicor, established as a subsidiary of Sepracor in 1995, completed various private equity transactions in April 1999, including the issuance of preferred
stock, which reduced Sepracor's ownership in Versicor to approximately 18%. As a result of these transactions, Sepracor recorded a gain of $1,077,000, which was recorded through additional paid-in
capital and began accounting for its investment in Versicor under the cost method. In October 1999, Versicor completed a private placement financing for approximately $40,000,000 in which
Sepracor paid $1,000,000 to Versicor for Versicor preferred stock. As a result of this transaction, Sepracor's ownership of Versicor was approximately 10% at December 31, 1999. In
August 2000, Versicor completed an initial public offering
36
of 5,290,000 shares of its common stock. Since Versicor's stock is now publicly traded, Sepracor considers its investment in Versicor as an available-for-sale security and as such Sepracor marks-to-
market its investment at the end of each reporting period. At December 31, 2001 and 2000, the market price of Versicor's common stock was $20.25 and $8.625 per share, respectively, which
resulted in the recording of unrealized gains of approximately $22,889,000 and $10,688,000, as a separate component of stockholders' equity as of December 31, 2001 and 2000, respectively.
As
of December 31, 2001, Sepracor owns 1,809,143 shares, or approximately 8%, of Versicor's outstanding common stock. Sepracor also has warrants to purchase an additional 76,250
shares of Versicor common stock at $5.00 per share, which expire in December 2002. Sepracor recognized $1,252,000 as other income in 2001 for changes in the valuation of the warrants at
December 31, 2001.
D) Cash, Cash Equivalents and Short-Term and Long-Term Investments
Cash, cash equivalents and short-term and long-term investments consist of the following at December 31:
(In Thousands)
2001
2000
Cash and Cash Equivalents:
Cash and money market funds
$
637,010
$
41,321
Corporate and Government commercial paper
78,072
312,737
Total cash and cash equivalents
$
715,082
$
354,058
Short
and long-term investments classified as available-for-sale or held-to-maturity consist of the following at December 31:
2001
2000
(In Thousands)
Available-
For-Sale
Held-to-
Maturity
Available-
For-Sale
Held-to-
Maturity
Due within 1 year
Corporate commercial paper
$
$
116,063
$
5,069
$
243,749
Due in greater than 1 year
Corporate commercial paper
27,678
45,566
26,641
4,962
Total short-term and long-term investments
$
27,678
$
161,629
$
31,710
$
248,711
Unrealized
gains on available-for-sale securities at December 31, 2001 and 2000 were approximately $23,000 and $60,000, respectively. Held-to-maturity securities are recorded at
cost plus accrued amortization, which approximates fair value. Realized gains and losses on available-for-sale and held-to-maturity securities were insignificant in 2001 and 2000.
The
Company also has an investment in Versicor, which it began classifying as an available-for-sale security in August 2000, upon Versicor's initial public offering. The Company
has marked to market its investment in Versicor at December 31, 2001 and has recorded an unrealized gain of approximately $22,889,000, which is included as a separate component of stockholders'
equity.
37
E) Financial Instruments
Financial instruments consist of the following at December 31:
2001
2000
(In Thousands)
Carrying Amount
Fair Value
Carrying Amount
Fair Value
6.25% convertible subordinated debentures, due 2005