SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934.
For the quarterly period ended March 31, 1999
[ ] TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934.
For the transition period from ________________ to _____________________
COMMISSION FILE NUMBER: 0-23556
INHALE THERAPEUTIC SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
- ------------------------------- --------------------------------
(State of other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
150 INDUSTRIAL ROAD
SAN CARLOS, CALIFORNIA 94070
(Address of principal executive offices)
(Registrant's telephone number, including area code)
(Former name, former address and former fiscal year, if changed since last
Indicate by check mark whether the registrant (1) has filed all reports required
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. [X] Yes [ ] No
APPLICABLE ONLY TO CORPORATE ISSUERS
The number of outstanding shares of the registrant's Common Stock, $0.0001 par
value, was 16,941,154 as of April 30, 1999.
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INHALE THERAPEUTIC SYSTEMS, INC.
PART I: FINANCIAL INFORMATION
Page 2 of 17
INHALE THERAPEUTIC SYSTEMS, INC.
CONDENSED BALANCE SHEETS
Item 1. Condensed Financial Statements - unaudited.............................................................3
Condensed Balance Sheets - March 31, 1999 and December 31, 1998........................................3
Condensed Statements of Operations for the three month periods ended
March 31, 1999 and 1998 ..........................................................................4
Condensed Statements of Cash Flows for the three month periods ended
March 31, 1999 and 1998...........................................................................5
Notes to Condensed Financial Statements................................................................6
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations.............................................................................7
Item 3. Quantitative and Qualitative Disclosures About Market Risk ...........................................15
PART II: OTHER INFORMATION
Item 1. Legal Proceedings.....................................................................................15
Item 2. Changes in Securities.................................................................................15
Item 3. Defaults Upon Senior Securities.......................................................................15
Item 4. Submission of Matters to a Vote of Security Holders...................................................15
Item 5. Other Information.....................................................................................15
Item 6. Exhibits and Reports on Form 8-K......................................................................15
MARCH 31, 1999 DECEMBER 31, 1998
SEE ACCOMPANYING NOTES.
(*) The balance sheet at December 31, 1998 has been derived from the audited
Financial Statements at that date but does not include all of the information
and footnotes required by generally accepted accounting principles for complete
Page 3 of 17
INHALE THERAPEUTIC SYSTEMS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE INFORMATION)
Cash and cash equivalents $18,023 $24,916
Short-term investments 55,553 57,946
Other current assets 3,231 1,678
Total current assets 76,807 84,540
Property and equipment, net 54,449 49,863
Deposits and other assets 93 93
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued liabilities $10,902 $8,397
Deferred revenue 3,755 4,359
Total current liabilities 14,657 12,756
Equipment financing obligations 1 9
Tenant improvement loan 4,924 4,931
Accrued rent 989 919
Common stock 2 2
Capital in excess of par value 172,918 172,847
Deferred compensation (869) (931)
Accumulated other comprehensive loss (32) (19)
Accumulated deficit (61,241) (56,018)
Total stockholders' equity 110,778 115,881
SEE ACCOMPANYING NOTES.
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INHALE THERAPEUTIC SYSTEMS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS
Contract research revenue $7,780 $3,865
Operating costs and expenses:
Research and development 12,716 7,217
General and administrative 1,264 1,925
Total operating costs and expenses 13,980 9,142
Loss from operations (6,200) (5,277)
Interest income, net 977 1,128
Net loss (5,223) (4,149)
Basic and diluted net loss per share ($0.31) ($0.27)
Shares used in computing
basic and diluted net loss per share 16,929 15,568
SEE ACCOMPANYING NOTES.
Page 5 of 17
INHALE THERAPEUTIC SYSTEMS, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
MARCH 31, 1999
1. ORGANIZATION AND BASIS OF PRESENTATION
Inhale Therapeutic Systems ("Inhale" or the "Company") was
incorporated in the State of California in July 1990 and reincorporated in
the State of Delaware in July 1998. Since inception, Inhale has been engaged
in the development of systems for the pulmonary delivery of macromolecule
drug therapies for systemic and local lung applications.
The accompanying unaudited condensed financial statements of
Inhale have been prepared by management in accordance with generally accepted
accounting principles for interim financial information and the instructions
for Form 10-Q and Article 10 of Regulation S-X. The balance sheet as of March
31, 1999 and the related statements of operations and cash flows for the
three month periods ended March 31, 1999 and 1998, are unaudited but include
all adjustments (consisting only of normal recurring adjustments) which
Inhale considers necessary for a fair presentation of the financial position
at such dates and the operating results and cash flows for those periods.
Although Inhale believes that the disclosures in these financial statements
are adequate to make the information presented not misleading, certain
information normally included in financial statements and related footnotes
prepared in accordance with generally accepted accounting principles have
been condensed or omitted pursuant to the rules and regulations of the
Securities and Exchange Commission (the "Commission"). The accompanying
financial statements should be read in conjunction with the financial
statements and notes thereto included in Inhale's Annual Report on Form 10-K
for the year ended December 31, 1998 as filed with the Commission.
Results for any interim period presented are not necessarily
indicative of results for any other interim period or for the entire year.
2. COMPREHENSIVE LOSS
Other comprehensive loss (primarily unrealized losses on available
for sale securities) amounted to $13,000 and $27,000, respectively, for the
three month periods ended March 31, 1999 and 1998.
3. REVENUE RECOGNITION
Contract revenue from collaborative research agreements is
recorded when earned and as the related costs are incurred. Payments received
which are related to future performance are deferred and recognized as
revenue when earned over future performance periods. In accordance with
contract terms, up-front and progress payments from collaborative research
agreements are considered to be payments to support continued research and
development activities under the agreements. In accordance with the Company's
revenue recognition policy, these payments are included in deferred revenue
and are recognized as the related research and development expenditures are
Contract research revenue from one partner represented 77% of
Inhale's revenue in the three month period ended March 31, 1999. Contract
revenue from two partners accounted for 67% of Inhale's revenue in the
corresponding period in 1998. Costs of contract research revenue approximate
such revenue and are included in operating costs and expenses.
4. NET LOSS PER SHARE
Basic and diluted net loss per common share is computed in
conformance with Statement of Financial Accounting Standards No. 128,
"Earnings Per Share", which Inhale adopted in 1997. Accordingly, the weighted
average number of common shares outstanding are used while common stock
equivalent shares for stock options and warrants are not included in the per
share calculations as the effect of their inclusion would be antidilutive.
Page 6 of 17
5. SEGMENT INFORMATION
Management has organized Inhale's business in one operating
segment which includes activities related to the development of systems for
the pulmonary delivery of macromolecule drugs. Inhale's operations are
presently located in the United States and Inhale derives all of its revenues
within the United States.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
This Management's Discussion and Analysis of Financial Condition
and Results of Operations for the three months ended March 31, 1999 and 1998
should be read in conjunction with the Management's Discussion and Analysis
of Financial Condition and Results of Operations included in Inhale's Annual
Report on Form 10-K for the year ended December 31, 1998. The following
discussion contains forward-looking statements that involve risk and
uncertainties. Inhale's actual results could differ materially from those
discussed here. Factors that could cause or contribute to such differences
include, but are not limited to, those discussed herein under the heading
"Risk Factors" as well as those discussed in Inhale's Annual Report on Form
10-K for the year ended December 31, 1998.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which reflect management's analysis only as of
the date hereof. Inhale undertakes no obligation to publicly release the
results of any revision to these forward-looking statements which may be made
to reflect events or circumstances occurring after the date hereof or to
reflect the occurrence of unanticipated events.
Since its inception in July 1990, Inhale has been engaged in the
development of a pulmonary system for the delivery of macromolecules and
other drugs for systemic and local lung applications. Inhale has been
unprofitable since inception and expects to incur significant and increasing
additional operating losses over the next several years primarily due to
increasing research and development expenditures and expansion of late stage
clinical and early stage commercial manufacturing facilities. To date, Inhale
has not sold any commercial products and does not anticipate receiving
revenue from product sales or royalties in the near future. For the period
from inception through March 31, 1999, Inhale incurred a cumulative net loss
of approximately $61.2 million. The sources of working capital have been
equity financings, financings of equipment acquisitions and tenant
improvements, interest earned on investments of cash, and revenues from
short-term research and feasibility agreements and development contracts.
Inhale typically has been compensated for research and development
expenses during initial feasibility work performed under collaborative
arrangements. Partners that enter into collaborative agreements will pay for
research and development expenses and make additional payments to Inhale as
Inhale achieves certain key milestones. Inhale expects to receive royalties
from its partners based on revenues received from product sales, and to
receive revenue from the manufacturing of powders and the supply of devices.
In certain cases, Inhale may enter into collaborative agreements under which
Inhale's partners would manufacture or package powders or supply inhalation
devices, thereby potentially limiting one or more sources of revenue for
Inhale. To achieve and sustain profitable operations, Inhale, alone or with
others, must successfully develop, obtain regulatory approval for,
manufacture, introduce, market and sell products utilizing its pulmonary drug
delivery system. There can be no assurance that Inhale can generate
sufficient product or contract research revenue to become profitable or to
RESULTS OF OPERATIONS
Revenue in the first quarter of 1999 was $7.8 million compared to
$3.9 million in the first quarter of 1998, an increase of approximately 100%.
The increase in revenue was primarily due to the expansion of Inhale's
existing collaborative agreement with Pfizer, Inc. and includes activities
associated with the manufacture of Phase III clinical supplies. Revenue for
the first quarter of 1999 and 1998 was comprised of reimbursed research and
development expenses as well as the amortization of the pro-rata portion of
up-front signing and progress payments received
Page 7 of 17
from Inhale's collaborative partners. Recognition of up-front signing and
progress payments is based on actual efforts expended. Costs of contract
research revenue approximate such revenue and are included in research and
Research and development expenses increased to approximately $12.7
million in the first quarter of 1999 from $7.2 million in the corresponding
period of 1998, an increase of 76%. The increase was due to the continued
expansion of the Company's manufacturing activities in order to support Phase
III clinical trials. In addition, the company hired additional scientific and
development personnel to handle an increase in the number of development
projects and incurred increased expenses associated with device development.
Inhale expects research, development and process development spending to
increase over the next few years as Inhale expands its development efforts
under collaborative agreements and scales up its commercial manufacturing
General and administrative expenses decreased to $1.3 million in
the first quarter of 1999 from $1.9 million in the first quarter of 1998, an
decrease of 32%. The decrease was due primarily to a change in the Company's
methodology for allocating administrative costs to research and development
expenses. In 1999 the Company began allocating human resources costs
associated with supporting the Inhale organization including administrative
staffing and business development and marketing activities. General and
administrative expenses are expected to continue to increase over the next
few years to support increasing levels of research, development and
Net interest income decreased to $1.0 million in the first quarter
of 1999 compared to $1.1 million in the first quarter of 1998, an decrease of
9%. Interest income was earned on lower cash and investment balances held by
Inhale in the three month period ended March 31, 1999, compared to the same
period in 1998.
LIQUIDITY AND CAPITAL RESOURCES
Inhale has financed its operations primarily through public and
private placements of its equity securities, contract research and milestone
payments, financing of equipment acquisitions and interest income earned on
its investments of cash. At March 31, 1999, Inhale had cash, cash equivalents
and short-term investments of approximately $73.6 million.
Inhale's operations used cash of $3.6 million in the three months
ended March 31, 1999, as compared to $8.2 million used in the three months
ended March 31, 1998. The decrease in cash used in operations was due
principally to the combination of decreased receivable and increased accrued
liability balances at March 31, 1999 compared to the same period in 1998.
Inhale purchased property and equipment of approximately $5.7
million during the three months ended March 31, 1999, compared to $8.8
million for the corresponding period in 1998. The decrease in purchased
property and equipment is due to the fact that 1998 spending included costs
related to the build out of Inhale's headquarters and first phase of its
manufacturing plant located in San Carlos, California, which is now largely
Inhale expects its cash requirements to continue to increase at an
accelerated rate due to expected increases in costs associated with further
research and development of its technologies, resulting in larger numbers of
projects, development of drug formulations, process development for the
manufacture and filling of powders and devices, marketing and general and
administrative costs. These expenses include, but are not limited to,
increases in personnel and personnel related costs, purchases of capital
equipment, investments in technologies, inhalation device prototype
construction and facilities expansion, including the completion of its late
stage clinical and commercial manufacturing facility.
Inhale believes that its cash, cash equivalents and short-term
investments as of March 31, 1999, together with interest income and possible
additional equipment financing, will be sufficient to meet its operating
expense and capital expenditure requirements at least through the first half
of 2000. However, Inhale's capital needs will depend on many factors,
including continued scientific progress in its research and development
arrangements, progress with pre-clinical and clinical trials, the time and
costs involved in obtaining regulatory approvals, the costs of developing and
the rate of scale-up of Inhale's powder processing and packaging
technologies, the timing and cost of its late-stage clinical and early
commercial production facility, the costs involved in preparing, filing,
prosecuting, maintaining and enforcing patent claims, the need to acquire
licenses to new technologies and the
Page 8 of 17
status of competitive products. To satisfy its long-term needs, Inhale
intends to seek additional funding, as necessary, from corporate partners and
from the sale of securities. There can be no assurance that additional funds,
if and when required, will be available to Inhale on favorable terms, if at
YEAR 2000 COMPLIANCE
Inhale is aware of the issues associated with the programming code
in existing computer systems as the millennium (Year 2000) approaches. The
Year 2000 ("Y2K") problem is pervasive and complex as virtually every
computer operation may be affected in some way by the rollover of the two
digit year value to "00". The issue is whether systems will properly
recognize date sensitive information when the year changes to 2000. If
Inhale's software and firmware with date-sensitive functions are not Y2K
compliant, they may recognize a date with "00" as the year 1900 rather than
the year 2000. This could result in a system failure or miscalculations
causing disruptions of operations, including, among other things,
interruptions in manufacturing operations, a temporary inability to process
transactions, or engage in similar normal business activities.
Inhale is utilizing both internal and external resources to
conduct a comprehensive review of its systems to identify those systems that
could be affected by the Y2K problem and has developed an implementation plan
to resolve the issue by the end of 1999. The scope of the Y2K effort includes
information technology ("IT") such as software and hardware, non-IT systems
or embedded technology such as microcontrollers contained in various
manufacturing and lab equipment, environmental and safety systems, facilities
and utilities, and the Y2K readiness of key third parties such as suppliers
and financial institutions. A multi-step Y2K readiness plan has been
developed for its internal systems. This plan includes the following
elements: 1) Awareness - raising Inhale's awareness of the Y2K issue; 2)
Discovery - keeping an inventory and monitoring the compliance status of key
financial, informational and operations systems subject to Y2K issues; 3)
Assessment - determining both the business impact of noncompliance and the
likelihood of noncompliance from each of the entities in the inventory; 4)
Validation Remediation - the process of validating entities to ascertain
compliance and remediate non-compliant entities. As of March 1999, Inhale had
completed the Awareness, Discovery and Assessment phases of the plan and is
working on the Validation Remediation phase of the plan.
Inhale has initiated formal communication with significant vendors
and suppliers to determine the extent to which Inhale's operations are
vulnerable to those third parties' failure to remediate their own Y2K issues.
Suppliers of hardware, software or other products that might contain embedded
processors were requested to provide information regarding Y2K compliance
status of their products. Inhale will continue to seek information from
non-responsive suppliers and plans to contact replacement vendors and
suppliers through the second quarter of 1999 and then implement appropriate
contingency plans. In addition, in order to protect against the acquisition
of additional non-compliant products, Inhale now requires suppliers to
warrant that products sold or licensed to Inhale are Y2K compliant. In the
event that any of Inhale's significant suppliers do not successfully achieve
Y2K compliance in a timely manner, Inhale's business or operations could be
adversely affected. There can be no assurance that the systems of other
companies on which Inhale's systems rely will be converted on a timely basis
and would not have an adverse effect on Inhale's operations.
As of March 31, 1999, Inhale has substantially developed a
comprehensive contingency plan to address situations that may result if
Inhale is unable to achieve Y2K readiness of its critical operations. The
contingency plan will be implemented should situations occur where Inhale is
unable to achieve Y2K readiness in its critical operations. There can be no
assurance that Inhale will be able to develop a contingency plan that will
adequately address issues that may arise in the year 2000. The failure of
Inhale to develop and implement, if necessary, an appropriate contingency
plan could have a material impact on the operations of Inhale. Finally,
Inhale is also vulnerable to external forces that might generally affect
industry and commerce, such as utility and transportation company Y2K
compliance failures and related service interruptions.
Inhale anticipates completing the mission critical, high impact
Y2K issues by the first half of 1999, which is prior to any anticipated
impact on its operating systems and expects the Y2K project to continue
beyond the year 2000 with respect to the upgrading, replacement and testing
of non-critical systems. These dates are contingent upon the timeliness and
accuracy of software and hardware upgrades from vendors, adequacy and quality
of resources available to work on completion of the project and any other
unforeseen factors. The total expense of the Y2K project is currently
estimated at approximately $750,000, of which approximately $350,000 has been
spent through March 31, 1999, which is not material to Inhale's business
operations or financial condition. The expenses of the Y2K project are being
funded through operating cash flows.
Page 9 of 17
The costs of the project and the date on which Inhale believes it
will complete the Y2K modifications are based on management's best estimates,
which were derived utilizing numerous assumptions of future events, including
the continued availability of certain resources, third-party modification
plans and other factors. There can be no assurance that these estimates will
be achieved and actual results could differ materially from those anticipated.
WE DO NOT KNOW IF OUR DEEP LUNG DRUG DELIVERY SYSTEM IS TECHNICALLY FEASIBLE.
We are in an early stage of development. There is a risk that our
deep lung delivery technology will not be technically feasible. Even if our
deep lung delivery technology is technically feasible, it may not be
commercially accepted across a range of large and small molecule drugs. We
have tested six of our thirteen deep lung delivery formulations in humans.
The deep lung formulations tested in humans are insulin, interleukin-1
receptor, salmon calcitonin, an osteoporosis drug and two small molecules.
Many of the underlying drug compounds contained in our deep lung
formulations have been tested in humans by other companies using alternative
delivery routes. Our potential products require extensive research,
development and pre-clinical (animal) and clinical (human) testing. Our
potential products also may involve lengthy regulatory review before they can
be sold. We do not know if and cannot assure that any of our potential
products will prove to be safe and effective or meet regulatory standards.
There is a risk that any of our potential products will not be able to be
produced in commercial quantities at acceptable cost or marketed
successfully. Our failure to achieve technical feasibility, demonstrate
safety, achieve clinical efficacy, obtain regulatory approval or, together
with partners, successfully market products will seriously impact the amount
of our revenue and our results of operations.
WE DO NOT KNOW IF OUR DEEP LUNG DELIVERY SYSTEM IS EFFICIENT.
We may not be able to achieve the total system efficiency needed
to be competitive with alternative routes of delivery. System efficiency is
the product of the deep lung bioavailability of a potential product and the
percentage of each drug dose lost at various stages of the manufacturing and
deep lung delivery process. Deep lung bioavailability is the percentage of a
drug that is absorbed into the bloodstream when that drug is delivered
directly to the lungs. This is the initial screen for whether deep lung
delivery of any systemic drug is feasible.
WE DO NOT KNOW IF OUR DEEP LUNG DRUG FORMULATIONS ARE STABLE.
We may not be able to identify and produce powdered versions of
drugs that retain the physical and chemical properties needed to work with
our delivery device. Formulation stability is the physical and chemical
stability of the drug over time and under various storage conditions.
Formulation stability will vary with each deep lung formulation and the type
and amount of ingredients that are used in the formulation. We would not
consider a drug to be a good candidate for development and commercialization
if its dose loss is excessive at any one stage or cumulatively in the
manufacturing and delivery process or if its deep lung bioavailability is too
low. Problems with powdered drug stability would seriously impact our ability
to develop and market our potential products.
WE DO NOT KNOW IF OUR DEEP LUNG SYSTEM IS SAFE.
We may not be able to prove potential products to be safe.
Our products require lengthy laboratory, animal and human testing.
For most of our products we are in the early stage of human testing. If we
find that any product is not safe, we will not be able to commercialize the
product. The safety of our deep lung formulations will vary with each drug
and the ingredients used in its formulation.
WE DO NOT KNOW IF OUR DEEP LUNG SYSTEM PROVIDES CONSISTENT DOSES OF MEDICINE.
We may not be able to provide reproducible dosages of stable
formulations sufficient to achieve clinical success. Reproducible dosing is
the ability to deliver a consistent and predictable amount of drug into the
bloodstream over time both for a single patient and across patient groups.
Reproducible dosing requires the development of:
Page 10 of 17
- an inhalation device that consistently delivers
predictable amounts of dry powder formulations to the
- accurate unit dose packaging of dry powder
- moisture resistant packaging.
We may not be able to develop reproducible dosing of any potential
product. The failure to do so means that we would not consider it a good
candidate for development and commercialization.
WE DO NOT KNOW IF OUR TECHNOLOGIES CAN BE INTEGRATED IN TIME TO BRING PRODUCT TO
We may not be able to integrate all of the relevant technologies
to provide an integrated deep lung delivery system. Our integrated approach
to systems development relies upon several different but related technologies:
- dry powder formulations;
- dry powder processing technology;
- dry powder packaging technology; and
- deep lung delivery devices.
At the same time we must:
- establish collaborations with partners;
- perform laboratory and clinical testing of potential
- scale-up our manufacturing processes.
We must accomplish all of these steps without delaying any aspect
of technology development. Any delay in one component of product or business
development could delay our ability to develop, obtain approval of or market
therapeutic products using our deep lung delivery technology.
OUR DEEP LUNG DELIVERY SYSTEM MAY NOT BE COMMERCIALLY ACCEPTED.
We may not be able to achieve commercial viability of our deep
lung delivery system. In order to sell any potential product, we must make it
commercially acceptable to the market. This means that we must:
- further refine our device prototype;
- complete scale-up of our powder processing system; and
- complete scale-up of our automated packaging system.
The failure to demonstrate deep lung bioavailability, achieve
total system efficiency, provide safe, reproducible dosages of stable
formulations or advance on a timely basis the numerous aspects of product and
business development will seriously impact the amounts of our revenues and
our results of operations.
WE EXPECT TO CONTINUE TO LOSE MONEY FOR THE NEXT SEVERAL YEARS.
We have never been profitable and, through March 31, 1999, have
incurred a cumulative deficit of approximately $61.2 million. We expect to
continue to incur substantial and increasing losses over at least the next
several years as we expand our research and development efforts, testing
activities and manufacturing operations, and as we complete our late stage
clinical and early commercial production facility. All of our potential
products are in
Page 11 of 17
research or in the early stages of development except for our insulin
collaboration. We have generated no revenues from approved product sales. Our
revenues to date have consisted primarily of payments under short-term
research and feasibility agreements and development contracts. To achieve and
sustain profitable operations, we must, alone or with others, successfully
develop, obtain regulatory approval for, manufacture, introduce, market and
sell products using our deep lung drug delivery system. There is a risk that
we will not generate sufficient product or contract research revenue to
become profitable or to sustain profitability.
WE DEPEND ON PARTNERS FOR REGULATORY APPROVALS AND COMMERCIALIZATION OF OUR
Since Inhale is in the business of developing technology for
delivering drugs to the lungs and licensing this technology to companies that
make and sell drugs, we do not have the people and other resources to do the
- make bulk drugs to be used as medicines;
- design and carry out large scale clinical studies;
- prepare and file documents necessary to obtain
government approval to sell a given drug product;
- market and sell our products when and if they are
When Inhale signs a license agreement to develop a product with a
drug company, the drug company agrees to do some or all of the things
described above. If our partner fails to do any of these things, Inhale
cannot complete the development of the product.
WE DO NOT KNOW IF WE WILL BE ABLE TO PRODUCE OUR PRODUCTS IN COMMERCIAL
We must scale-up our current powder processing and filling
facilities and comply with the good manufacturing practice standards
prescribed by the United States Food and Drug Administration and other
standards prescribed by other regulatory agencies to achieve drug production
levels that are adequate to support late stage human clinical testing and
early commercial sales.
We have no experience manufacturing products for large scale
clinical testing or commercial purposes. We have only performed powder
processing on the small scale needed for testing formulations and for early
stage and larger clinical trials. We may encounter manufacturing and control
problems as we attempt to scale-up powder processing facilities. We may not
be able to achieve such scale-up in a timely manner or at a commercially
reasonable cost, if at all. Our failure to solve any of these problems could
delay or prevent late stage clinical testing and commercialization of our
products and could seriously impact the amount of our revenues and our
results of operations.
To date, we have relied on one particular method of powder
processing. There is a risk that this technology will not work with all drugs
or that the drug losses will prohibit the commercial viability of certain
drugs. Additionally, there is a risk that any alternative powder processing
methods we may pursue will not be commercially practical for aerosol drugs or
that we will not have or be able to acquire the rights to use such
Our fine particle powders and small quantity packaging require
special handling. We have designed and qualified small scale automated
filling equipment for small quantity packaging of fine powders. We face
significant technical challenges in scaling-up an automated filling system
that can handle the small dose and particle sizes of our powders in
commercial quantities. There is a risk that we will not be able to scale-up
our automated filling equipment in a timely manner or at commercially
reasonable costs. Any failure or delay in such scale-up would delay product
development or bar commercialization of our products and will impact the
level of our revenues and results of operations.
We face many technical challenges in further developing our
inhalation device to work with a broad range of drugs, to produce such a
device in sufficient quantities and to adapt the device to different powder
formulations. There is a risk that we will not successfully achieve any of
these things. Our failure to overcome any of these challenges will impact our
revenues and results of operations.
Page 12 of 17
For late stage clinical trials and initial commercial production,
we intend to use one or more contract manufacturers to produce our device.
There is a risk that we will not be able to enter into or maintain
arrangements with any potential contract manufacturers, and that the failure
to do so will impact our revenues and results of operations.
WE DO NOT KNOW IF THE MARKET WILL ACCEPT INHALE'S DEEP LUNG DELIVERY SYSTEM.
The commercial success of our potential products depends upon
market acceptance by health care providers, third-party payors, like health
insurance companies and Medicare, and patients. Our products under
development use a new method of drug delivery and there is a risk that our
potential products will not be accepted by the market. Market acceptance will
depend on many factors, including
- the safety and efficacy results of our clinical trials;
- favorable regulatory approval and product labeling;
- the frequency of product use;
- the availability of third-party reimbursement;
- the availability of alternative technologies; and
- the price of our products relative to alternative
There is a risk that health care providers, patients or
third-party payors will not accept our deep lung drug delivery system. If the
market does not accept our potential products, our revenues and results of
operations will be seriously impacted if our potential products are not
accepted by the market.
OUR PATENTS MAY NOT PROTECT OUR PRODUCTS AND OUR PRODUCTS MAY INFRINGE ON THIRD
PARTY PATENT RIGHTS.
Inhale has filed patent applications covering certain aspects of
our device, powder processing technology, and powder formulations and deep
lung route of delivery for certain molecules, and we plan to file additional
patent applications. Currently we have 36 issued U.S. and foreign patents
that cover certain aspects of our technology and we have a number of patent
applications pending. There is a risk that any of the patents applied for
will not issue, or that any patents that issue or have issued will not be
valid and enforceable. Enforcing our patent rights would be time consuming
We are aware of an alternate dry powder processing technology that
we are not using for our current products under development but may desire to
use for certain products in the future. The ownership of this powder
processing technology is unclear. We are aware that multiple parties,
including Inhale, claim patent, trade secret and other rights in the
technology. If we determine that this alternate powder processing technology
is relevant to the development of future products and further determine that
a license to this alternate powder processing technology is needed, we cannot
be certain that we can obtain a license from the relevant party or parties on
commercially reasonable terms, if at all.
Our access or our partners' access to the drugs to be formulated
will affect our ability to develop and commercialize our technology. Many
drugs, including powder formulations of certain drugs that are presently
under development by us, are subject to issued and pending United States and
foreign patents that may be owned by our competitors. We know that there are
issued patents and pending patent applications relating to the deep lung
delivery of large molecule drugs, including several for which we are
developing deep lung delivery formulations. This situation is highly complex,
and the ability of any one company, including Inhale, to commercialize a
particular drug is unpredictable.
We intend generally to rely on the ability of our partners to
provide access to the drugs that are to be formulated by us for deep lung
delivery. There is a risk that our partners will not be able to provide
access to such drug candidates. Even if such access is provided, there is a
risk that our partners or we will be accused of, or determined to be,
infringing a third-party's patent rights and will be prohibited from working
with the drug or be found liable for
Page 13 of 17
damages that may not be subject to indemnification. Any such restriction on
access to drug candidates or liability for damages would impact the level of
our revenues and results of operations.
WE MAY NOT OBTAIN REGULATORY APPROVAL.
There is a risk that we will not obtain regulatory approval for
our products on a timely basis, or at all. Our product must undergo rigorous
animal and human testing and an extensive review process mandated by the FDA
and equivalent foreign authorities. This process generally takes a number of
years and requires the expenditure of substantial resources although the time
required for completing such testing and obtaining such approvals is
uncertain. We have not submitted any of our products to the FDA for marketing
approval. We have no experience obtaining such regulatory approval.
In addition, we may encounter delays or rejections based upon
changes in the United States Food and Drug Administration policy, including
policy relating to good manufacturing practice compliance, during the period
of product development. We may encounter similar delays in other countries.
Even if regulatory approval of a product is granted, the approval
may limit the indicated uses for which we may market our product. In
addition, our marketed product, our manufacturing facilities and Inhale, as
the manufacturer, will be subject to continual review and periodic
inspections. Later discovery from such review and inspection of previously
unknown problems may result in restrictions on our product or on us,
including withdrawal of our product from the market. The failure to obtain
timely regulatory approval of our products, any product marketing limitations
or a product withdrawal would impact the level of our revenue and results of
IF OUR PRODUCTS ARE NOT COST EFFECTIVE, GOVERNMENT AND PRIVATE INSURANCE PLANS
WILL NOT PAY FOR OUR PRODUCTS.
In both domestic and foreign markets, sales of our products under
development will depend in part upon the availability of reimbursement from
third-party payors, such as government health administration authorities,
managed care providers, private health insurers and other organizations. In
addition, such third-party payors are increasingly challenging the price and
cost effectiveness of medical products and services. Significant uncertainty
exists as to the reimbursement status of newly approved health care products.
Legislation and regulations affecting the pricing of pharmaceuticals may
change before our proposed products are approved for marketing. Adoption of
such legislation and regulations could further limit reimbursement for
medical products. A government third party payor decision to not provide
adequate coverage and reimbursements for our products would limit market
acceptance of such products.
OUR COMPETITORS MAY DEVELOP AND SELL BETTER DRUG DELIVERY SYSTEMS.
We are aware of other companies engaged in developing and
commercializing pulmonary drug delivery systems and enhanced injectable drug
delivery systems. Many of these companies have greater research and
development capabilities, experience, manufacturing, marketing, financial and
managerial resources than we do and represent significant competition for us.
Acquisitions of competing drug delivery companies by large pharmaceutical
companies could enhance our competitors' financial, marketing and other
resources. Accordingly, our competitors may succeed in developing competing
technologies, obtaining United States Food and Drug Administration approval
for products or gain market acceptance before us. We cannot assure that
developments by others will not make our products or technologies
uncompetitive or obsolete.
WE EXPECT OUR STOCK PRICE TO REMAIN VOLATILE.
Our stock price is volatile. In the last twelve months our stock
price ranged from $20.125 and $35.25 we expect it to remain volatile. A
variety of factors may have a significant effect on the market price of our
common stock, including:
- fluctuations in our operating results;
- announcements of technological innovations or new
Page 14 of 17
- announcement or termination of collaborative
relationships by Inhale or our competitors;
- governmental regulation;
- clinical trial results;
- developments in patent or other proprietary rights;
- public concern as to the safety of drug formulations
developed by Inhale or others; and
- general market conditions.
Any litigation instigated against us as a result of this
volatility could result in substantial costs and a diversion of our
management's attention and resources, which could impact our revenues and
results of operations.
INVESTORS SHOULD BE AWARE OF INDUSTRY-WIDE RISKS.
In addition to the risks associated specifically with Inhale
described above, investors should also be aware of general risks associated
with drug development and the pharmaceutical industry. These include but are
not limited to:
- handling of hazardous materials;
- hiring and retaining qualified people; and
- insuring against product liability claims.
ITEM 3 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There have been no material changes in the reported market risks since December
PART II: OTHER INFORMATION
Item 1. Legal Proceedings - Not Applicable
Item 2. Changes in Securities - None
Item 3. Defaults upon Senior Securities - None
Item 4. Submission of Matters to a Vote of Security Holders - None
Item 5. Other Information- None
Item 6. Exhibits and Reports on Form 8-K
The following exhibits are filed herewith or incorporated by
EXHIBIT EXHIBIT TITLE
- ----------------- -----------------------------------------------------------
2.1 Agreement and Plan of Merger Between Inhale Therapeutic
Systems, a California Corporation, and Inhale Therapeutic
Systems (Delaware), a Delaware Corporation
3.1 Certificate of Incorporation of the Registrant.
3.2 Bylaws of the Registrant.
4.1 Reference is made to Exhibits 3.1 through 3.2.
4.2 (1) Restated Investor Rights Agreement among the Registrant and
certain other persons named therein, dated April 29, 1993, as
amended October 29, 1993.
4.6 (1) Specimen stock certificate.
Page 15 of 17
4.9 (2) Stock Purchase Agreement between the Registrant and Pfizer
Inc., dated January 18, 1995.
4.12 (9) Form of Stock Purchase Agreement between the Registrant and
the Selling Shareholders dated January 28, 1997.
10.1 (4) Registrant's 1994 Equity Incentive Plan, as amended (the
"Equity Incentive Plan").
10.2 (1) Form of Incentive Stock Option under the Equity Incentive
10.3 (1) Form of Nonstatutory Stock Option under the Equity Incentive
10.4 (7) Registrant's 1994 Non-Employee Directors' Stock Option Plan,
10.5 (1) Registrant's 1994 Employee Stock Purchase Plan.
10.6 (1) Standard Industrial Lease between the Registrant and W.F.
Batton & Co., Inc., dated September 17, 1992, as amended
September 18, 1992.
10.8 (1) Senior Loan and Security Agreement between the Registrant and
Phoenix Leasing Incorporated, dated September 15, 1993.
10.9 (1) Sublicense Agreement between the Registrant and John S.
Patton, dated September 13, 1991.
10.11(2) Lease dated September 17, 1992, between the Registrant and
W.F. Batton & Marie A. Batton.
10.13 (6) Addendum Number One to Lease dated September 17, 1992, between
the Registrant and W.F. Batton & Marie A. Batton.
10.15 (6) Addendum Number Two to Lease dated September 17, 1992, between
the Registrant and W.F. Batton & Marie A. Batton.
10.16 (5) Stock Purchase Agreement between the Registrant and Baxter
World Trade Corporation, dated March 1, 1996.
10.17 (8) Sublease and Lease Agreement, dated October 2, 1996 between
the Registrant and T.M.T. Associates L.L.C.
27.1 Financial Data Schedule
(1) Incorporated by reference to the indicated exhibit in Inhale's
Registration Statement (No. 33-75942), as amended.
(2) Incorporated by reference to the indicated exhibit in Inhale's
Registration Statement (No. 33-89502), as amended.
(3) Incorporated by reference to the indicated exhibit in Inhale's Annual
Report on Form 10-K for the year ended December 31, 1994.
(4) Incorporated by reference to Inhale's Registration Statement on Form S-8
(5) Incorporated by reference to the indicated exhibit in Inhale's Quarterly
Report on Form 10-Q for the quarter ended March 31, 1996.
(6) Incorporated by reference to the indicated exhibit in Inhale's Annual
Report on Form 10-K for the year ended December 31, 1995.
(7) Incorporated by reference to the indicated exhibit in Inhale's Quarterly
Report on Form 10-Q for the quarter ended June 30, 1996.
(8) Incorporated by reference to the indicated exhibit in Inhale's Quarterly
Report on Form 10-Q for the quarter ended September 30, 1996.
(9) Incorporated by reference to Inhale's Registration Statement on Form S-3
(b) Reports on Form 8-K.
(c) See Exhibits listed under Item 14(a)(3).
Page 16 of 17
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
INHALE THERAPEUTIC SYSTEMS, INC.
DATE: May 13, 1999 BY: /S/Robert B. Chess
Robert B. Chess
Co-Chief Executive Officer and Director
(Duly Authorized Officer)
BY: /S/Ajit S. Gill
Ajit S. Gill
Co-Chief Executive Officer and Director
(Duly Authorized Officer)
BY: /S/Christian O. Henry
Christian O. Henry
(Chief Accounting Officer)
Page 17 of 17
CASH FLOWS FROM OPERATING ACTIVITIES:
Cash used in operations $(3,586) $(8,164)
CASH FLOWS FROM INVESTING ACTIVITIES:
Sale of short-term investments, net of purchases and maturities 2,382 12,756
Purchases of property and equipment (5,744) (8,774)
Net cash (used in) provided by investing activities (3,362) 3,982
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments of equipment financing obligations (16) (20)
Issuance of common stock, net of issuance costs 71 651
Net cash provided by financing activities 55 631
Net increase (decrease) in cash and cash equivalents (6,893) (3,551)
Cash and cash equivalents at beginning of period 24,916 14,948
Cash and cash equivalents at end of period $18,023 $11,397