Exhibit 99
Item 5. OTHER EVENTS.
1. Penwest is providing below under the caption "Risk Factors" an updated
description of the risks and uncertainties which could materially affect
Penwest's business, financial condition and results of operations.
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should
carefully consider the risks and uncertainties described below, along with the
other information contained or incorporated by reference in this report, before
you decide to buy any common stock. The risks and uncertainties described below
are not the only ones affecting us. Additional risks and uncertainties may also
adversely affect our business and operations. If any of the following events
actually occur, our business, financial condition, or results of operations
would likely suffer, possibly materially. In that case, the trading price of our
common stock could fall, and you could lose all or part of the money you paid to
buy our common stock.
WE HAVE NOT BEEN PROFITABLE
We have incurred net losses since 1994, including net losses of
approximately $8.8 million, $7.7 million, and $8.8 million during 2000, 1999,
and 1998, respectively. As of March 31, 2000, our accumulated deficit was
approximately $47.1 million. The Company expects net losses to continue at least
into mid 2003. A substantial portion of our revenues have been generated from
the sales of our pharmaceutical excipients. Our future profitability will depend
on several factors, including:
- the completion of the development of and successful commercialization of
pharmaceutical products using our TIMERx controlled release technology;
- the addition of new product development collaborations;
- an increase in sales of our pharmaceutical excipient products; and
- the amount of our funding obligations under certain of our
collaborations.
WE ARE DEPENDENT ON COLLABORATORS TO CONDUCT FULL-SCALE BIOEQUIVALENCE STUDIES
AND CLINICAL TRIALS, OBTAIN REGULATORY APPROVALS FOR, AND MANUFACTURE, MARKET,
AND SELL OUR TIMERx CONTROLLED RELEASE PRODUCTS
We develop and commercialize our TIMERx controlled release products in
collaboration with pharmaceutical companies. We are parties to collaborative
agreements with third parties relating to certain of our principal products, for
instance, we are relying on Ivax to conduct full-scale bioequivalence studies
and clinical trials, obtain regulatory approvals for, and manufacture, market
and sell one of our TIMERx controlled release products and Endo to develop and
commercialize an extended release version of oxymorphone. We are also dependent
on Mylan with respect to the marketing and sale of the 30 mg strength of
Pfizer's generic version of Procardia XL. Our collaborators may not devote the
resources necessary or may otherwise be unable to complete development and
commercialization of these potential products. Our existing collaborations are
subject to termination without cause on short notice under certain
circumstances.
If we cannot maintain our existing collaborations or establish new
collaborations, we would be required to terminate the development and
commercialization of products or undertake product development and
commercialization activities at our own expense. Moreover, we have limited
experience in conducting full-scale bioequivalence studies and clinical trials,
preparing and submitting regulatory applications and manufacturing, marketing
and selling our TIMERx controlled release products. We may not be successful in
performing these activities.
Our existing collaborations and any future collaborations with third
parties may not be scientifically or commercially successful. Factors that may
affect the success of our collaborations include the following:
- our collaborators may be pursuing alternative technologies or developing
alternative products, either on their own or in collaboration with
others, that may be competitive with the product as to which they are
collaborating with us, which could affect our collaborators' commitment
to the collaboration with us;
- reductions in marketing or sales efforts or a discontinuation of
marketing or sales of our products by our collaborators would reduce our
revenues, which will be based on a percentage of net sales by the
collaborator;
2
- our collaborators may terminate their collaborations with us, which could
make it difficult for us to attract new collaborators or adversely affect
our perception in the business and financial communities; and
- our collaborators may pursue higher priority programs or change the focus
of their development programs, which could affect the collaborators'
commitment to us.
WE FACE SIGNIFICANT COMPETITION, WHICH MAY RESULT IN OTHERS DISCOVERING,
DEVELOPING OR COMMERCIALIZING PRODUCTS BEFORE OR MORE SUCCESSFULLY THAN WE DO
The pharmaceutical industry is highly competitive and is affected by new
technologies, governmental regulations, health care legislation, availability of
financing, litigation and other factors. Many of our competitors have longer
operating histories and greater financial, marketing, legal and other resources
than we do and than certain of our collaborators do.
Our TIMERx business faces competition from numerous public and private
companies and their controlled release technologies, including ALZA
Corporation's oral osmotic pump (OROS(R)) technology, multiparticulate systems
marketed by Elan Corporation PLC and Biovail Corporation International,
traditional matrix systems marketed by SkyePharma, PLC and other controlled
release technologies marketed or under development by Andrx Corporation, among
others.
In addition to developing controlled release versions of immediate release
products, we are also developing generic versions of branded controlled release
products. The success of generic versions of branded controlled release products
based on our TIMERx technology will depend, in large part, on the intensity of
competition from the branded controlled release product, other generic versions
of the branded controlled release product and other drugs and technologies that
compete with the branded controlled release product, as well as the timing of
product approval.
The generic drug industry is characterized by frequent litigation between
generic drug companies and branded drug companies. Those companies with
significant financial resources will be better able to bring and defend any such
litigation.
In our excipients business, we compete with a number of large manufacturers
and other distributors of excipient products, many of which have substantially
greater financial, marketing and other resources than the Company. Our principal
competitor in this market is FMC Corporation, which markets its own line of MCC
excipient products and J. Rettenmaier & Sohne GmbH, a European manufacturer and
marketer of MCC and sodium starch glycolate products.
WE MAY REQUIRE ADDITIONAL FUNDING
Our requirements for additional capital are substantial and will depend on
many factors, including:
- the timing and amount of payments received under existing and possible
future collaborative agreements;
- the structure of any future collaborative or development agreements;
- the progress of our collaborative and independent development projects;
- revenues from our excipients business;
- the costs to us of clinical studies for our products; and
- the prosecution, defense and enforcement of patent claims and other
intellectual property rights.
We have no committed sources of capital except for a credit facility with
CIT Group/Business Credit. We anticipate our existing capital resources,
including the amount available under the $10 million financing arrangement with
CIT Group/Business Credit and the proceeds from the sale of shares in the
private placement pursuant to which the selling stockholders acquired the shares
being offered hereby, will be sufficient to fund operations through late 2002.
Penwest may need to raise additional funds thereafter. Any additional financing
may not be available to Penwest on acceptable terms, if it all.
3
If adequate funds are not available, Penwest may be required to:
- significantly curtail its product commercialization efforts, including
terminating existing collaborative agreements;
- obtain funds through arrangements with collaborative partners or others
on favorable terms that may require Penwest to relinquish rights to
certain of its technologies, product candidates, or products which
Penwest would otherwise pursue on its own or that would significantly
dilute the Company's stockholders;
- significantly scale back or terminate operations; and/or
- seek relief under applicable bankruptcy laws.
IF OUR CLINICAL TRIALS ARE NOT SUCCESSFUL OR TAKE LONGER TO COMPLETE THAN WE
EXPECT, WE MAY NOT BE ABLE TO DEVELOP AND COMMERCIALIZE CERTAIN OF OUR PRODUCTS
In order to obtain regulatory approvals for the commercial sale of certain
of our potential products, including controlled release versions of immediate
release drugs and new chemical entities, our collaborators will be required to
complete clinical trials in humans to demonstrate the safety and efficacy of the
products. Our collaborators may not be able to obtain authority from the FDA or
other regulatory agencies to commence or complete these clinical trials.
The results from preclinical testing of a product that is under development
may not be predictive of results that will be obtained in human clinical trials.
In addition, the results of early human clinical trials may not be predictive of
results that will be obtained in larger scale advanced stage clinical trials.
Furthermore, we, one of our collaborators, or the FDA may suspend clinical
trials at any time if the subjects or patients participating in such trials are
being exposed to unacceptable health risks, or for other reasons.
The rate of completion of clinical trials is dependent in part upon the
rate of enrollment of patients. Patient accrual is a function of many factors
including the size of the patient population, the proximity of patients to
clinical sites, the eligibility criteria for the study and the existence of
competitive clinical trials. Delays in planned patient enrollment may result in
increased costs and program delays.
We and our collaborators may not be able to successfully complete any
clinical trial of a potential product within any specified time period. In some
cases, we may not be able to complete the trial at all. Moreover, clinical
trials may not show any potential product to be safe or efficacious. Thus, the
FDA and other regulatory authorities may not approve any of our potential
products for any indication.
Our business, financial condition, or results of operations could be
materially adversely affected if:
- we or our collaborators are unable to complete a clinical trial of one of
our potential products;
- the results of any clinical trial are unfavorable; or
- the time or cost of completing the trial exceeds our expectations.
WE MAY NOT OBTAIN REGULATORY APPROVAL AND THE APPROVAL PROCESS CAN BE
TIME-CONSUMING AND EXPENSIVE
The development, clinical testing, manufacture, marketing and sale of
pharmaceutical products are subject to extensive federal, state and local
regulation in the United States and other countries. This regulatory approval
process can be time-consuming and expensive.
We may encounter delays or rejections during any stage of the regulatory
approval process based upon the failure of clinical data to demonstrate
compliance with, or upon the failure of the product to meet, the FDA's
requirements for safety, efficacy and quality; and those requirements may become
more stringent due to changes in regulatory agency policy or the adoption of new
regulations. After submission of a marketing application, in the form of an NDA
or an ANDA, the FDA may deny the application, may require additional testing or
data and/or may require postmarketing testing and surveillance to monitor the
safety or efficacy of a product. While the U.S. Food, Drug and Cosmetic Act, or
FDCA, provides for a 180-day review period, the FDA commonly takes one to two
years to grant final approval to a marketing application (NDA or ANDA).
4
Further, the terms of approval of any marketing application, including the
labeling content, may be more restrictive than we desire and could affect the
marketability of products incorporating our controlled release technology.
Most of our products in development containing our TIMERx controlled
release technology require the filing of an NDA. A full NDA must include
complete reports of preclinical, clinical and other studies to prove adequately
that the product is safe and effective, which involves, among other things, full
clinical testing, and as a result requires the expenditure of substantial
resources. In certain cases involving controlled release versions of
FDA-approved immediate release drugs, we may be able to rely on existing
publicly available safety and efficacy data to support an NDA for controlled
release products under Section 505(b)(2) of the FDCA when such data exists for
an approved immediate release version of the same chemical entity. However, we
can provide no assurance that the FDA will accept such section 505(b)(2) NDA, or
that we will be able to obtain publicly available data that is useful. The
section 505(b)(2) NDA process is a highly uncertain avenue to approval because
the FDA's policies on section 505(b)(2) NDAs have not yet been fully developed.
There can be no assurance that the FDA will approve an application submitted
under section 505(b)(2) in a timely manner or at all.
Some products in our portfolio are generic versions of branded controlled
release products, which require the filing of ANDAs. Certain ANDA procedures for
generic versions of controlled release products are the subject of petitions
filed by brand name drug manufacturers, which seek changes from the FDA in the
approval process for generic drugs. These requested changes include, among other
things, tighter standards for certain bioequivalence studies and disallowance of
the use by a generic drug manufacturer in its ANDA of proprietary data submitted
by the original manufacturer as part of an original new drug application. Any
changes in FDA regulations that make ANDA approvals more difficult may have a
material adverse effect on our business, financial condition and results of
operations.
The FDA also has the authority to revoke or suspend approvals of previously
approved products for cause, to debar companies and individuals from
participating in the drug-approval process, to request recalls of allegedly
violative products, to seize allegedly violative products, to obtain injunctions
to close manufacturing plants allegedly not operating in conformity with current
Good Manufacturing Practices (GMP) and to stop shipments of allegedly violative
products. The FDA may seek to impose pre-clearance requirements on products
currently being marketed without FDA approval, and there can be no assurance
that the Company or its third-party manufacturers or collaborators will be able
to obtain approval for such products within the time period specified by the
FDA.
EVEN IF WE OBTAIN MARKETING APPROVAL, OUR PRODUCTS WILL BE SUBJECT TO ONGOING
REGULATORY REVIEW
If regulatory approval of a product is granted, such approval 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. As
to products for which marketing approval is obtained, the manufacturer of the
product and the manufacturing facilities will be subject to continual review and
periodic inspections by the FDA and other regulatory authorities. The subsequent
discovery of previously unknown problems with the product, manufacturer or
facility may result in restrictions on the product or manufacturer, including
withdrawal of the product from the market.
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.
OUR CONTROLLED RELEASE PRODUCTS THAT ARE GENERIC VERSIONS OF BRANDED CONTROLLED
RELEASE PRODUCTS THAT ARE COVERED BY ONE OR MORE PATENTS MAY BE SUBJECT TO
LITIGATION
We expect that our collaborators will file ANDAs for our controlled release
products that are generic versions of branded controlled release products that
are covered by one or more patents. It is likely that the owners of the patents
covering the brand name product or the sponsors of the NDA with respect to the
branded product will sue or undertake regulatory initiatives to preserve
marketing exclusivity, as Pfizer did with respect to Nifedipine XL. Any
significant delay in obtaining FDA approval to market our product
5
candidates as a result of litigation, as well as the expense of such litigation,
whether or not we or our collaborators are successful, could have a material
adverse effect on our business, financial condition and results of operations.
THE MARKET MAY NOT BE RECEPTIVE TO PRODUCTS INCORPORATING OUR TIMERx CONTROLLED
RELEASE TECHNOLOGY
The commercial success of products incorporating our controlled release
technology that are approved for marketing by the FDA and other regulatory
authorities will depend upon their acceptance by the medical community and third
party payors as clinically useful, cost-effective and safe.
Other factors that we believe could materially affect market acceptance of
these products include:
- the timing of the receipt of marketing approvals and the countries in
which such approvals are obtained;
- the safety and efficacy of the product as compared to competitive
products; and
- the cost-effectiveness of the product and the ability to receive third
party reimbursement.
OUR SUCCESS DEPENDS ON OUR PROTECTING OUR PATENTS AND PATENTED RIGHTS
Our success depends in significant part on our ability to develop
patentable products, to obtain patent protection for our products, both in the
United States and in other countries, and to enforce these patents. The patent
positions of pharmaceutical firms, including us, are generally uncertain and
involve complex legal and factual questions. As a result, patents may not issue
from any patent applications that we own or license. If patents do issue, the
claims allowed may not be sufficiently broad to protect our technology. In
addition, issued patents that we own or license may be challenged, invalidated
or circumvented. Our patents also may not afford us protection against
competitors with similar technology.
Our success also depends on our not infringing patents issued to
competitors or others. We are aware of patents and patent applications belonging
to competitors and others that may require us to alter our products or
processes, pay licensing fees or cease certain activities.
We may not be able to obtain a license to any technology owned by a third
party that we require to manufacture or market one or more products. Even if we
can obtain a license, the financial and other terms may be disadvantageous.
Our success also depends on our maintaining the confidentiality of our
trade secrets and patented know-how. We seek to protect such information by
entering into confidentiality agreements with employees, consultants, licensees
and pharmaceutical companies. These agreements may be breached by such parties.
We may not be able to obtain an adequate, or perhaps, any remedy to such a
breach. In addition, our trade secrets may otherwise become known or be
independently developed by our competitors.
WE ARE INVOLVED IN AND MAY BECOME INVOLVED IN ADDITIONAL PATENT LITIGATION OR
OTHER INTELLECTUAL PROPERTY PROCEEDINGS RELATING TO OUR PRODUCTS OR PROCESSES
WHICH COULD RESULT IN LIABILITY FOR DAMAGE OR STOP OUR DEVELOPMENT AND
COMMERCIALIZATION EFFORTS
The pharmaceutical industry has been characterized by significant
litigation and interference and other proceedings regarding patents, patent
applications and other intellectual property rights. The types of situations in
which we may become parties to such litigation or proceedings include:
- We or our collaborators may initiate litigation or other proceedings
against third parties to enforce our patent rights.
- We or our collaborators may initiate litigation or other proceedings
against third parties to seek to invalidate the patents held by such
third parties or to obtain a judgment that our products or processes do
not infringe such third parties' patents.
6
- If our competitors file patent applications that claim technology also
claimed by us, we or our collaborators may participate in interference or
opposition proceedings to determine the priority of invention.
- If third parties initiate litigation claiming that our processes or
products infringe their patent or other intellectual property rights, we
and our collaborators will need to defend against such proceedings.
An adverse outcome in any litigation or other proceeding could subject us
to significant liabilities to third parties and require us to cease using the
technology that is at issue or to license the technology from third parties. We
may not be able to obtain any required licenses on commercially acceptable terms
or at all.
The cost of any patent litigation or other proceeding, even if resolved in
our favor, could be substantial. Although the legal costs of defending
litigation relating to a patent infringement claim (unless such claim relates to
TIMERx in which case such costs are our responsibility) are generally the
contractual responsibility of our collaborators, we could nonetheless incur
significant unreimbursed costs in participating and assisting in the litigation.
Some of our competitors may be able to sustain the cost of such litigation and
proceedings more effectively than we can because of their substantially greater
resources. Uncertainties resulting from the initiation and continuation of
patent litigation or other proceedings could have a material adverse effect on
our ability to compete in the marketplace. Patent litigation and other
proceedings may also absorb significant management time.
In 1994, the Boots Company PLC ("Boots") filed in the European Patent
Office, or the EPO, an opposition to a patent granted by the EPO to us relating
to our TIMERx technology. In June 1996, the EPO dismissed Boots' opposition,
leaving intact all claims included in the patent. Boots appealed this decision
to the EPO Board of Appeals, which conducted oral proceedings on the appeal in
June 2001. At the oral proceedings, the EPO Board of Appeals upheld the
validity of all the claims included in the patent other than three claims which
we cancelled during the oral proceedings. We believe that the cancelled claims
were duplicative in scope to the claims that were upheld and that the
cancellation of those claims did not result in any change in the scope of the
claims of the patent. The decision of the EPO Board of Appeals is final and
cannot be further appealed by Boots in the EPO.
WE HAVE ONLY LIMITED MANUFACTURING CAPABILITIES AND WILL BE DEPENDENT ON THIRD
PARTY MANUFACTURERS.
We lack commercial scale facilities to manufacture our TIMERx material in
accordance with current GMP requirements prescribed by the FDA. We currently
rely on a third party pharmaceutical company for the bulk manufacture of our
TIMERx material for delivery to our collaborators.
There are a limited number of manufacturers that operate under GMP
regulations capable of manufacturing our TIMERx material. We have not yet
qualified a second source of supply. In the event that our current manufacturer
is unable to manufacture the TIMERx material in the required quantities or at
all, we may be unable to obtain alternative contract manufacturing, or obtain
such manufacturing on commercially reasonable terms.
If our third party manufacturer fails to perform its obligations, we may be
adversely affected in a number of ways, including:
- our collaborators may not be able to meet commercial demands for our
products on a timely basis;
- our collaborators may not be able to initiate or continue clinical trials
of products that are under development; and
- our collaborators may be delayed in submitting applications for
regulatory approvals of our products.
We have limited experience in manufacturing TIMERx material on a commercial
scale and no facilities or equipment to do so. If we decide to develop our own
manufacturing capabilities, we will need to recruit qualified personnel and
build or lease the requisite facilities and equipment. We may not be able to
successfully develop our own manufacturing capabilities. Moreover, it may be
very costly and time consuming for us to develop such capabilities.
7
The manufacture of any of our products (both TIMERx material and
excipients) is subject to regulation by the FDA and comparable agencies in
foreign countries. Any delay in complying or failure to comply with such
manufacturing requirements could materially adversely affect the marketing of
our products and our business, financial condition and results of operations.
WE ARE DEPENDENT UPON A SOLE SOURCE SUPPLIER FOR THE GUMS USED IN OUR TIMERx
MATERIAL AND UPON A LIMITED NUMBER OF SUPPLIERS FOR THE WOOD PULP USED IN THE
MANUFACTURE OF OUR EXCIPIENTS
Our TIMERx drug delivery system is a hydrophilic matrix combining primarily
two polysaccharides, xanthan and locust bean gums, in the presence of dextrose.
We purchase these gums from a sole source supplier. Emcocel and Prosolv, our two
largest selling excipients, are manufactured from a specialty grade of wood
pulp. We have qualified alternate suppliers with respect to such materials, but
we can provide no assurance that interruptions in supplies will not occur in the
future or that we will not have to obtain substitute suppliers. Any interruption
in these supplies could have a material adverse effect on our ability to
manufacture bulk TIMERx for delivery to our collaborators or to manufacture
these excipients.
IF OUR COLLABORATORS FAIL TO OBTAIN AN ADEQUATE LEVEL OF REIMBURSEMENT BY THIRD
PARTY PAYORS FOR OUR CONTROLLED RELEASE PRODUCTS, THEY MAY NOT BE ABLE TO
SUCCESSFULLY COMMERCIALIZE CONTROLLED RELEASE PRODUCTS IN CERTAIN MARKETS
The availability of reimbursement by governmental and other third party
payors affects the market for any pharmaceutical product. These third party
payors continually attempt to contain or reduce the costs of health care by
challenging the prices charged for medical products and services. In certain
foreign countries, particularly the countries of the European Union, the pricing
of prescription pharmaceuticals is subject to governmental control.
The generic versions of controlled release products being developed by us
and our collaborators may be assigned an AB rating if the FDA considers the
product to be therapeutically equivalent to the branded controlled release drug.
Failure to obtain an AB rating from the FDA would indicate that for certain
purposes the drug would not be deemed to be therapeutically equivalent, would
not be fully substitutable for the branded controlled release drug and would not
be relied upon by Medicaid and Medicare formularies for reimbursement.
In both the U.S. and certain foreign jurisdictions, there have been a
number of legislative and regulatory proposals to change the health care system.
Further proposals are likely. The potential for adoption of these proposals may
affect our ability to raise capital, obtain additional collaborative partners
and market our products.
If we or our collaborators obtain marketing approvals for our products, we
expect to experience pricing pressure due to the trend toward managed health
care, the increasing influence of health maintenance organizations and
additional legislative proposals. We may not be able to sell our products
profitably if reimbursement is unavailable or limited in scope or amount.
WE WILL BE EXPOSED TO PRODUCT LIABILITY CLAIMS AND MAY NOT BE ABLE TO OBTAIN
ADEQUATE PRODUCT LIABILITY INSURANCE
Our business exposes us to potential product liability risks which are
inherent in the testing, manufacturing, marketing and sale of pharmaceutical
products. Product liability claims might be made by consumers, health care
providers or pharmaceutical companies or others that sell our products. These
claims may be made even with respect to those products that are manufactured in
licensed and regulated facilities or that otherwise possess regulatory approval
for commercial sale.
We are currently covered by primary product liability insurance in the
amount of $1.0 million per occurrence and $2.0 million annually in the aggregate
on a claims-made basis and by umbrella liability insurance in excess of $25.0
million which can also be used for product liability insurance. This coverage
may not be adequate to cover any product liability claims. Product liability
coverage is expensive. In the future, we may not be able to maintain or obtain
such product liability insurance at a reasonable cost or in sufficient
8
amounts to protect us against losses due to liability claims. Any claims that
are not covered by product liability insurance could have a material adverse
effect on our business, financial condition and results of operations.
THE MARKET PRICE OF OUR COMMON STOCK MAY BE VOLATILE
The market price of our common stock, like the market prices for securities
of pharmaceutical, biopharmaceutical and biotechnology companies, have
historically been highly volatile. The market from time to time experiences
significant price and volume fluctuations that are unrelated to the operating
performance of particular companies. Factors such as fluctuations in our
operating results, future sales of our common stock, announcements of
technological innovations or new therapeutic products by us or our competitors,
announcements regarding collaborative agreements, clinical trial results,
government regulation, developments in patent or other proprietary rights,
public concern as to the safety of drugs developed by us or others, changes in
reimbursement policies, comments made by securities analysts and general market
conditions may have a significant effect on the market price of the common
stock.
CERTAIN PROVISIONS OF OUR CERTIFICATE OF INCORPORATION AND BYLAWS AND OF
WASHINGTON LAW, AS WELL AS THE RIGHTS AGREEMENT TO WHICH WE ARE A PARTY, MAKE A
TAKEOVER OF PENWEST MORE DIFFICULT
Provisions of our Certificate of Incorporation, our Bylaws and Washington
law, as well as the Rights Agreement to which we are a party, may have the
effect of deterring hostile takeovers or delaying or preventing changes in
control or management of our company, including transactions in which our
stockholders might otherwise receive a premium for their shares over then
current market prices. In addition, these provisions may limit the ability of
stockholders to approve transactions that they may deem to be in their best
interest.
9