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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
FOR ANNUAL AND TRANSITION REPORTS
PURSUANT TO SECTIONS 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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(Mark One)
/X/ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the fiscal year ended DECEMBER 31, 1997
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from to
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Commission file number 1-12584
SHEFFIELD PHARMACEUTICALS, INC.
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(Name of Registrant as Specified in its Charter)
DELAWARE 13-3808303
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(State or Other Jurisdiction (IRS Employer
of Incorporation or Organi- Identification Number)
zation)
425 Woodsmill Road, St. Louis, Missouri 63017
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(Address of Principal Executive Offices) (Zip Code)
Issuer's Telephone Number, Including Area Code: (314) 579-9899
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Securities registered pursuant to Section 12(b) of the Exchange Act:
TITLE OF EACH CLASS Name of Each Exchange
------------------- ON WHICH REGISTERED
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Common Stock, $.01 par value American Stock Exchange
Securities registered pursuant to Section 12(g) of the Exchange Act:
None
Indicate by check mark whether the registrant: (1) has filed
all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act 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.
Yes /X/ No / /
(CONTINUED ON NEXT PAGE)
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/ / Indicate by check mark if disclosure of delinquent filers to
Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of the registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K.
The aggregate market value at March 31, 1998 of the voting
stock of the Registrant held by non-affiliates (based upon the closing price of
$0.6875 per share of such stock on the American Stock Exchange on such date) was
approximately $10,197,487. Solely for the purposes of this calculation, shares
held by directors and officers of the issuer have been excluded. Such exclusion
should not be deemed a determination or an admission by the issuer that such
individuals are, in fact, affiliates of the issuer.
Indicate the number of shares outstanding of each of the
registrant's classes of common equity, as of the latest practicable date: At
March 31, 1998, there were outstanding 15,742,762 shares of the issuer's Common
Stock, $.01 par value.
DOCUMENTS INCORPORATED BY REFERENCE
Certain portions of the Registrant's definitive proxy
statement to be filed not later than April 30, 1998 pursuant to Regulation 14A
are incorporated by reference in Items 10 through 13 of Part III of this Annual
Report on Form 10-K.
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PART I
ITEM 1. BUSINESS
GENERAL
Sheffield Pharmaceuticals, Inc. (the "Company"), formerly known as
Sheffield Medical Technologies Inc., is an emerging pharmaceutical company
developing and commercializing prescription pharmaceutical products to be
promoted by a specialty pharmaceutical sales force. The Company is in the
development stage and as such has been principally engaged in the development of
its proprietary drug delivery system, the Premaire(TM) Metered Solution Inhaler
(the "Premaire(TM) MSI System"). The Company's lead products are four
respiratory drugs for the treatment of asthma and chronic obstructive pulmonary
disease ("COPD"). These drugs will be delivered to the lungs by the Premaire(TM)
MSI System, the world-wide marketing rights to which were in-licensed by the
Company from Siemens AG in March 1997. In addition, the Company is actively
seeking partners for the development of other respiratory and non-respiratory
drugs for delivery via the Premaire(TM) MSI System. Finally, the Company is
seeking to out- license its rights in several early-stage biomedical
technologies.
The Company does not currently have any sales or marketing
capabilities. It intends to build or otherwise acquire a specialty
pharmaceutical sales force in the United States, as well as the attendant
marketing infrastructure, as its lead products near marketing approval.
The Company was originally formed in 1986 and is incorporated in
Delaware. In 1996, the Company formed a wholly owned Delaware subsidiary, Ion
Pharmaceuticals, Inc. ("Ion"), that owns the rights to certain early- stage
biomedical technologies. In 1997, the Company acquired all of Camelot Pharmacal,
L.L.C., a Missouri limited liability corporation that was subsequently
liquidated. Unless the context requires otherwise, references to the "Company"
herein are references to Sheffield Pharmaceuticals, Inc. and its subsidiaries.
The Company's headquarters are located at Suite 270, 425 South
Woodsmill Road, St. Louis, Missouri 63017-3441 and its telephone number is (314)
579-9899.
BUSINESS STRATEGY
The principal elements of the Company's business strategy consist of
the following: (i) marketing its products directly through the Company's future
specialty sales force; (ii) selectively acquiring, in-licensing, co- promoting
or obtaining currently marketed pharmaceutical products in selected markets;
(iii) focusing on certain chronic diseases, such as asthma, requiring long-term
therapy in the large, rapidly growing concentrated respiratory market with a
range of drugs delivered by the Premaire(TM) MSI System, (as further described
below); and (iv) contracting for the manufacture and development of its products
with cost effective, high quality U.S. Food and Drug Administration ("FDA")
compliant companies.
The Company's management consists of individuals who possess
substantial experience in the acquisition, development and commercialization of
pharmaceutical products. Through their experience at such companies as Bock
Pharmacal Company and Fisons plc, members of the Company's management team have
demonstrated the ability to build and manage the operations of successful
pharmaceutical companies. This team provides the Company with extensive industry
contacts together with broad and complementary business and scientific skills,
which are critical to achieving success in the pharmaceutical industry.
PROJECTS UNDER DEVELOPMENT
PREMAIRE(TM) MSI SYSTEM
BACKGROUND
The Company owns the exclusive worldwide rights to the Premaire(TM) MSI
System, a patented, state-of-the- art, multi-dose nebulizer delivery system (the
" Premaire(TM) MSI System") from Siemens AG, the multi-national engineering and
electronics conglomerate. The system is comprised of a hand-held, pocket-sized,
ultrasonic nebulizer, and dosator cartridges containing various medications. The
pharmaceutical formulations currently in development by the Company for use with
the Premaire(TM) MSI System are for the treatment of asthma and COPD. Through
the Premaire(TM) MSI System and the products under development for use in the
Premaire(TM) MSI System, the Company plans to be a significant competitor in the
respiratory category by the year 2001. Siemens AG will
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manufacture and supply the hand-held nebulizer component of the Premaire(TM) MSI
System. The Company is in the development phase for commonly used respiratory
drugs for use with the Premaire(TM) MSI System.
PULMONARY DRUG DELIVERY MARKET ENVIRONMENT
The Premaire(TM) MSI System pulmonary drug delivery system for which
the Company holds exclusive worldwide rights has been developed to meet specific
needs within the respiratory market, particularly for those patients suffering
from asthma and COPD. In 1995, audited industry sources indicated there were
approximately 10 million asthma patients and 3 million COPD patients under
physician care in the U.S. Other sources indicate that there are at least 14
million asthma patients being treated by physicians and that the number of newly
diagnosed patients is growing at a rate of 10% annually. With the aging of the
population, it is believed that COPD is growing at a similar rate. Because the
Company will initially focus its future specialty sales force in the U.S., the
following information will focus on the U.S. market potential for the
Premaire(TM) MSI System. There remains an opportunity to play a significant role
in other markets outside of the U.S., particularly in Europe.
Today, three principal types of devices are widely used in aerosol
administration: metered dose inhalers (MDIs), dry powder inhalers (DPIs), and
nebulizers.
METERED DOSE INHALERS. Currently, MDIs are the most commonly used
aerosol delivery system. It is estimated that in the United States, 80%
of aerosol drug delivery is via MDIs, with the majority of this use
coming from adults with asthma and COPD.
The primary advantages of an MDI include its small size/portability,
drug delivery time in seconds, and availability with most respiratory
drugs. Disadvantages include patient coordination issues and efficient
dose delivery. Additionally, because the use of chlorofluorocarbon
(CFC) propellants, traditionally used in MDIs, is being phased out
according to international agreement (Montreal Protocol), alternative
propellants and formulations are being developed. Over time, all
current MDI users will be required to move to a non-CFC MDI or other
alternative delivery systems.
DRY POWDER INHALERS. DPIs were introduced in the 1960s as single-dose
inhalers. In these devices, the drug is loaded as a unit dose that is
mechanically released as a powder for inhalation prior to each use. To
date, these systems have been the primary form of DPI available in the
United States, and account for approximately 1% of the total aerosol
delivery market.
The inconvenience of the single dose DPI has been overcome outside of
the U.S. with the development and introduction of multidose DPIs that
can deliver up to 200 doses of medication. However, like the single
dose systems, they are likely to be inspiratory flow rate dependent,
that is, the amount of drug delivered to the lung is dependent upon the
patient's ability to inhale.
Two of the most significant advantages of DPIs include 1) no
hand-breath coordination is required as with MDIs; and 2) they contain
no CFCs. However, most require a high inspiratory flow rate that can be
problematic in younger patients or in patients with compromised lung
function. In addition, they often present difficulties for those with
manual disabilities (e.g., arthritis) or limited vision and, depending
upon the powder load delivered, may induce acute bronchospasm in
sensitive individuals.
NEBULIZERS. The third widely-used aerosol delivery system is the
nebulizer. Jet nebulizers, which are by far the most commonly used,
work on a stream of compressed air or oxygen that is forced through a
narrow tube which lies just above the surface of the liquid to be
nebulized. It takes approximately 10 to 15 minutes to nebulize this
amount of liquid. During nebulization only about 10% of the drug is
delivered to the lungs; about 80% gets trapped in the reservoir, tubing
and mask; the rest is exhaled.
Nebulizers can be used for a wide range of patients, but are especially
useful for those old and young patients who cannot manage other inhaler
devices, and for whom inhalation via tidal breathing is preferred.
Nebulizers also play a key role in emergency room and intensive care
treatment for patients with acute bronchospasm. However, most
nebulizers are bulky units that are time consuming, have a high initial
cost and can be extremely noisy during operation.
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PROJECTED MARKET ENVIRONMENT
The Company believes that the U.S. respiratory market will exceed $4
billion by the year 2001. Many developments are taking place in the technology
associated with pulmonary drug delivery. Spurred on by the Montreal Protocol and
the ban on CFC propellants, much of the work in research and development has
focused on alternative propellants and dry powder systems. It is anticipated
that there will be a minimum of 11 and a maximum of 35 approved CFC-free inhaled
products on the market in the United States by 2001. Many of these are expected
to be MDIs with new propellants or DPIs. However, few of these second generation
delivery systems are expected to overcome the disadvantages associated with
their earlier counterparts.
There are a number of new devices in development that have been
designed specifically to address unmet patient needs. Among these is the
Company's patented metered solution inhaler, the Premaire(TM) MSI System, which
is designed to combine the therapeutic benefits of nebulization with the
convenience of pressurized metered dose inhalers.
DESCRIPTION OF THE TECHNOLOGY
The Premaire(TM) MSI System is a metered solution inhaler comprised of
two main components: (i) a reusable, pocket-size inhaler unit developed and
manufactured for the Company by Siemens AG, a global leader in electronics and
technology, and (ii) interchangeable drug cartridges called dosators. The basic
technology of the system involves the rapid nebulization of therapeutic agents
for the respiratory tract using ultrasonic energy. This produces a concentrated
cloud of medication delivered through the mouthpiece over a two to three second
period for inhalation. Key components of the technology include rechargeable
batteries, a battery-operated motor, ultrasonic horn, drug cartridge chamber and
mouthpiece.
The pocket-size Premaire(TM) MSI System accommodates a variety of drug
dosators to allow for administration of a range of drugs in a single,
simple-to-use, environmentally-friendly delivery system. Each dosator contains
120 actuations containing approximately a one to two month supply of drug.
The Premaire(TM) MSI System is designed to be patient friendly. A
patient simply selects the appropriate color-coded drug cartridge and places it
into the chamber of the inhaler unit. Pressing the "on" button activates the
small electrical motor that transports a precise dose of drug from the cartridge
chamber to the ultrasonic horn which transforms the solution into an aerosolized
cloud. The patient's inspiration carries a cloud of medication directly to the
lungs where it is needed. The Company expects the delivered dose to be accurate
and consistent for the following reasons: (i) the Premaire(TM) MSI System is
designed to be inspiratory flow rate independent, that is, delivery of the drug
does not depend upon the patient's ability to inhale forcefully, and (ii) the
Premaire(TM) MSI System does not require a high level of coordination between
inspiration and actuation of the device. The patient's breath carries the
medication directly to the lungs, minimizing the amount of drug deposited in the
mouth and throat.
POTENTIAL ADVANTAGES OF THE PREMAIRE(TM) MSI SYSTEM.
The Company believes that the Premaire(TM) MSI System may provide significant
advantages over other drug delivery systems. It is particularly suited for
younger and older asthma patients, and for older COPD patients who have
difficulty using MDIs and currently have to depend on larger, more
time-consuming table-top nebulizers for delivery of their medications. These
potential advantages include:
ACCURACY. The superior engineering and patient-friendly design
of the Premaire(TM) MSI System is intended to provide minimal dose to
dose variability. Patients can therefore expect to consistently receive
the correct therapeutic dose.
ENHANCED PATIENT COMPLIANCE. The pocket-size, portable
Premaire(TM) MSI System unit is designed to combine the therapeutic
benefits of nebulization with the convenience of pressurized metered
dose inhalers. Drug delivery time is measured in seconds, as compared
to 10 - 15 minutes or more for the typical nebulizer. Plus, the device
is easy to operate and requires minimal coordination between actuation
and inhalation for proper drug delivery. All of these features
contribute to improved patient compliance resulting from proper
administration of their respiratory medication.
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INSPIRATORY FLOW RATE INDEPENDENCE. The Premaire(TM) MSI
System is designed to achieve a consistent and significant level of
drug deposition over a broad range of inspiratory flow rates. This is
especially important in younger patients or in patients with
compromised lung function (e.g., during an asthma attack).
VERSATILITY. Many asthma and COPD patients are taking multiple
inhalation medications. The Premaire(TM) MSI System accommodates
interchangeable drug cartridges, or dosators, to allow for the
administration of a broad range of frequently used respiratory drugs in
a single, simple to use delivery system. The system utilizes early
warning mechanism to signal when the batteries need recharging. These
user-friendly features result in a simplified dosing procedure for both
patients and their caregivers.
ENVIRONMENTALLY-FRIENDLY. CFCs are associated with the
reduction of the Earth's ozone layer, and are subject to worldwide
regulations aimed at eliminating their production and use within the
decade. The Premaire(TM) MSI System does not use CFCs or any other type
of ozone depleting propellant.
ECONOMICAL. The Premaire(TM) MSI System offers significant
value to the patient because it allows a single device to be used with
a complete family of respiratory medications available in
cost-effective interchangeable cartridges. The inhaler unit itself has
a life of three years for a patient who uses it several times a day.
THE PREMAIRE(TM) DEVELOPMENT STRATEGY
The Company is implementing a two-tier development strategy for the
Premaire(TM) MSI System as described below:
DEVELOP AND COMMERCIALIZE FOUR NON-PATENTED INHALED
RESPIRATORY MEDICATIONS. The Company, in collaboration with Chesapeake
Biological Laboratories, is currently developing four widely used
respiratory drugs for use in the Premaire(TM) MSI System. These
include: albuterol sulfate, ipratropium bromide, cromolyn sodium and an
inhaled bronchial steroid.
IDENTIFY CORPORATE PARTNERS. The Company plans to identify
potential foreign marketing partner or partners for the four initial
compounds in the Premaire(TM) MSI System. The Company plans to market
albuterol, ipratropium, cromolyn and an inhaled steroid in the U.S.
through the use of a planned specialty sales force. The Company is
currently in the process of identifying potential marketing partners
outside of the U.S. to cover major foreign markets.
The Company plans to sublicense the Premaire(TM) MSI System
technology to pharmaceutical companies for use with new respiratory
drugs/non-respiratory drugs. The Company is actively exploring
out-licensing opportunities for developing new respiratory medications
for the Premaire(TM) MSI System, as well as exploring expansion of the
Premaire(TM) MSI for the pulmonary delivery of drugs to the bloodstream
(e.g., insulin, morphine). Out-licensing, manufacturing and supply
agreements with such companies would provide the Company with
additional revenue sources.
EARLY STAGE RESEARCH PROJECTS
As part of the Company's focus on later stage opportunities, the
Company is seeking to out-license its portfolio of early stage medical research
projects to companies that are committed to early stage biotechnology
opportunities. This portfolio consists of opportunities within the Company's
wholly-owned subsidiary, Ion, which are focused on development of new compounds
for the treatment of cancer and other diseases. In addition, the Company has
rights to potential products in the areas of human immunodeficiency virus
("HIV"), Acquired Immune Deficiency Syndrome ("AIDS") and prostrate cancer.
These early stage technologies do not fit the emerging pharmaceutical company
strategy. Consequently, the Company plans to outlicense these technologies while
maintaining an interest in the technologies' promise without incurring the
development costs associated with early stage research and development.
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RBC-CD4 ELECTROINSERTION TECHNOLOGY
The Company is the worldwide licensee of certain technology (the
"RBC-CD4 Electroinsertion Technology") relating to the electroinsertion of
full-length CD4 protein into red blood cells for use as a potential therapeutic
in the treatment of HIV that leads to AIDS. The electroinsertion process inserts
CD4, the protein that serves as the binding site of the HIV virus, into a red
blood cell. This altered cell complex acts as a decoy and is designed to cleanse
the blood of infection by binding to and removing the HIV virus from circulation
before it can infect other cells in the human immune system.
The Company has signed an option agreement with a private investment
group that had a prior interest in the RBC-CD4 Electroinsertion Technology, to
sell the Company's rights to this HIV/AIDS technologies. As consideration for
the option, the third party will fund an additional study related to the RBC-CD4
Electroinsertion Technology. In addition, the Company will retain a one-third
interest in all future commercial and sublicensing results.
LIPOSOME-CD4 TECHNOLOGY
The Company is the worldwide licensee of certain technology (the
"Liposome-CD4 Technology") relating to the incorporation of CD4 antigens into
liposome bilayers and their use as a potential therapeutic agent in the
treatment of HIV/AIDS. Liposome-CD4 Technology has been targeted by the Company
at infections in the human lymphatic system, a major reservoir for infection not
directly reached by blood circulation.
The Company entered into a sublicense agreement in July 1996 with
SEQUUS Pharmaceuticals, Inc. ("SEQUUS") for the continued development and
commercialization of the Liposome-CD4 Technology. Under development by SEQUUS, a
clinical formulation prototype has been chosen, a scaleable process to formulate
Liposome-CD4 has been developed, CD4 from various constructs are being produced,
and additional feasibility studies are currently underway.
HIV/AIDS VACCINE
The Company holds an exclusive worldwide license to a potential
HIV/AIDS vaccine (the "HIV/AIDS Vaccine") and diagnostic test under development
at the French Institute of Health and Medical Research ("INSERM"). This research
project is headed by Professor Jean-Claude Chermann, one of the original Pasteur
Institute discoverers of the HIV virus. The vaccine concept developed by
Professor Chermann targets an antibody binding site or "epitope" which is on a
region of the beta-2-microglobulin that is normally associated with the Class I
major histocompatability molecule found on the surface of most human cells. It
is believed that inducing an antibody to this epitope could either prevent the
progression of existing HIV infection or entirely prevent infection of
uninfected individuals. The Company believes this approach may also protect
against both blood-born and sexual transmission of HIV. The Company's goal has
been to develop an oral formulation that would make the vaccine potentially less
costly and easier to distribute to a broad population.
The Company is seeking a partner for this technology .
UGIF TECHNOLOGY - PROSTATE CANCER
The Company holds an exclusive worldwide license to a growth regulatory
factor, termed Urogenital Sinus Derived Growth Inhibitory Factor ("UGIF/ps20"),
which could serve as a potential prostate cancer therapy (the "UGIF
Technology"). Identification of UGIF as a growth inhibitory factor for certain
prostate cells was based upon laboratory studies conducted at Baylor Medical
College. This work identifies the potential of UGIF for the treatment of
prostate cancer and potentially other diseases of the prostate by elucidating
mechanisms involved in the control of growth in the prostate. The Company is
seeking a partner for this technology.
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ION PHARMACEUTICALS, INC. TECHNOLOGIES
The Company, through its wholly-owned subsidiary, Ion, holds exclusive
worldwide license rights to certain compounds and their uses for the treatment
of conditions characterized by unregulated cell proliferation or cell growth and
sickle cell anemia. Ion's intellectual property portfolio consists of
clotrimazole ("CLT"), its metabolites and a number of proprietary new chemical
entities co-owned by Ion termed the Trifens(TM). Such compounds have
demonstrated promise in therapeutic applications for treating a number of
conditions characterized by unregulated cell proliferation, such as cancer
(including multiple drug resistance cases) and certain proliferative
dermatological conditions, as well as sickle cell anemia and secretory diarrhea.
Ion acquired the Company's rights in the anti- proliferative technologies at the
time of Ion's organization as a wholly-owned subsidiary of the Company in
January 1996.
The Company entered into a license arrangement with Imutec Pharma Inc.
in November 1997. The arrangement licenses rights to a series of compounds for
the treatment of cancer, Kaposi's sarcoma and actinic keratosis to a newly
formed company, NuChem Pharmaceuticals, Inc. ("NuChem") for which Imutec Pharma
will provide funding and management of the development program. The Company
holds a 20% equity interest in NuChem. The Company is currently participating in
discussions with certain third parties regarding the possibility of partnering
or licensing the use of clotrimazole and the Trifens(TM) in the fields of sickle
cell anemia and gastrointestinal disorders.
GOVERNMENT REGULATION
The Company's research and development activities and, ultimately, the
production and marketing of its licensed products, are subject to comprehensive
regulation by numerous governmental authorities in the United States and other
countries. Among the applicable regulations in the United States, pharmaceutical
products are subject to the Federal Food, Drug & Cosmetic Act, the Public Health
Services Act, other federal statutes and regulations, and certain state and
local regulations. These regulations and statutes govern the development,
testing, formulation, manufacture, labeling, storage, record keeping, quality
control, advertising, promotion, sale, distribution and approval of such
pharmaceutical products. Failure to comply with applicable requirements can
result in fines, recall or seizure of products, total or partial suspension of
production, refusal by the government to approve marketing of the product and
criminal prosecution.
A new drug may not be legally marketed for commercial use in the United
States without Food and Drug Administration (the "FDA") approval. In addition,
upon approval, a drug may only be marketed for the indications, in the
formulations and at the dosage levels approved by the FDA. The FDA also has the
authority to withdraw approval of drugs in accordance with applicable laws and
regulations. Analogous foreign regulators impose similar approval requirements
relating to commercial marketing of a drug in their respective countries and may
impose similar restrictions and limitations after approval.
In order to obtain FDA approval of a new product, the Company and its
strategic partners must submit proof of safety, efficacy, purity and stability,
and the Company must demonstrate validation of its manufacturing process. The
testing and application process is expensive and time consuming, often taking
several years to complete. There is no assurance that the FDA will act favorably
or quickly in reviewing such applications. With respect to patented products,
processes or technologies, delays imposed or caused by the governmental approval
process may materially reduce the period during which the Company will have the
exclusive right to exploit them. Such delays could also affect the commercial
advantages derived from proprietary processes.
As part of the approval process, the FDA reviews the Drug Master File
(the "DMF") for a description of product chemistry and characteristics, detailed
operational procedures for product production, quality control, process and
methods validation, and quality assurance. As process development continues to
mature, updates and modifications of the DMF are submitted.
The FDA approval process for a pharmaceutical product includes review
of (i) chemistry and formulations, (ii) preclinical laboratory and animal
studies, (iii) initial Investigational New Drug Application (the "IND") clinical
studies to define safety and dose parameters, (iv) well-controlled IND clinical
trials to demonstrate product efficacy and safety, followed by submission and
FDA approval of a New Drug Application (the "NDA"). Preclinical studies involve
laboratory evaluation of the product and animal studies to assess activity and
safety of the product. Products must be formulated in accordance with United
States Good Manufacturing Procedures ("GMP") requirements and preclinical tests
must be conducted by laboratories that comply with FDA regulations governing the
testing of drugs
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in animals. The results of the preclinical tests are submitted to the FDA as
part of the IND application and are reviewed by the FDA prior to granting the
sponsor permission to conduct clinical studies in human subjects. Unless the FDA
objects to an IND application, the application will become effective 30 days
following its receipt by the FDA. There can be no certainty that submission of
an IND will result in FDA authorization to commence clinical studies.
Human clinical trials are typically conducted in three sequential
phases with some amount of overlap allowed. Phase I trials normally consist of
testing the product in a small number of patient volunteers for establishing
safety and pharmacokinetics using single and multiple dosing regiments. In Phase
II, the continued safety and initial efficacy of the product are evaluated in a
somewhat larger patient population, and appropriate dosage amounts and treatment
intervals are determined. Phase III trials typically involve more definitive
testing of the appropriate dose for safety and clinical efficacy in an expanded
patient population at multiple clinical testing centers. A clinical plan, or
"protocol," accompanied by the approval of the institution participating in the
trials, must be submitted to the FDA prior to commencement of each clinical
trial phase. Each clinical study must be conducted under the auspices of an
Institutional Review Board (the "IRB") at the institution performing the
clinical study. The IRB is charged with protecting the safety of patients in
trials and may require changes in a protocol, and there can be no assurance that
an IRB will permit any given study to be initiated or completed. In addition,
the FDA may order the temporary or permanent discontinuation of clinical trials
at any time. The Company must rely on other persons and institutions to conduct
these clinical studies.
All the results of the preclinical and clinical studies on a
pharmaceutical product are submitted to the FDA in the form of an NDA for
approval to commence commercial distribution. The information contained in the
DMF is also incorporated into the NDA. Submission of an NDA does not assure FDA
approval for marketing. The application review process often required 12 months
to complete. However, the process may take substantially longer if the FDA has
questions or concerns about a product or studies regarding the product. In
general, the FDA requires two adequate and controlled clinical studies
demonstrating efficacy with sufficient levels of statistical assurance. However,
additional support may be required. The FDA also may request additional
information relating to safety or efficacy, such as long-term toxicity studies.
In responding to an NDA, the FDA may grant marketing approval, require
additional testing and/or information, or deny the application. Accordingly,
there can be no assurance about any specific time frame for approval, if any, of
products by the FDA or foreign regulatory agencies. Continued compliance with
all FDA requirements and conditions relative to an approved application,
including product specifications, manufacturing process, labeling and
promotional material, and record keeping and reporting requirements, is
necessary throughout the life of the product. In addition, failure to comply
with FDA requirements, the occurrence of unanticipated adverse effects during
commercial marketing or the result of future studies, could lead to the need for
product recall or other FDA-initiated actions that could delay further marketing
until the products or processes are brought into compliance.
The facilities of each pharmaceutical manufacturer must be registered
with and approved by the FDA as compliant with GMP. Continued registration
requires compliance with standards for GMP. In complying with GMP, manufacturers
must continue to expend time, money and effort in production, record keeping and
quality control to ensure technical compliance. In addition, manufacturers must
comply with the United States Department of Health and Human Services and
similar state and local regulatory authorities if they handle controlled
substances, and they must be registered with the United States Environmental
Protection Agency and similar state and local regulatory authorities if they
generate toxic or dangerous waste streams. Other regulatory agencies such as the
Occupational Safety and Health Administration also monitor a manufacturing
facility for compliance. Each of these organizations conducts periodic
establishment inspections to confirm continued compliance with its regulations.
Failure to comply with any of these regulations could mean fines, interruption
of production and even criminal prosecution.
For foreign markets, a pharmaceutical company is subject to regulatory
requirements, review procedures and product approvals which, generally, may be
as extensive, if not more extensive, as those in the United States. Although the
technical descriptions of the clinical trials are different, the trials
themselves are often substantially the same as those in the United States.
Approval of a product by regulatory authorities of foreign countries must be
obtained prior to commencing commercial product marketing in those countries,
regardless of whether FDA approval has been obtained. The time and cost required
to obtain market approvals in foreign countries may be longer or shorter than
required for FDA approval and may be subject to delay. There can be no assurance
that regulatory authorities of foreign countries will grant approval. The
Company has no experience in manufacturing or marketing in foreign countries nor
in matters such as currency regulations, import-export controls or other trade
laws.
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PATENTS AND PROPRIETARY RIGHTS
PREMAIRE(TM) MSI SYSTEM PATENTS
Under its agreement with Siemens AG for the technology underlying the
Premaire(TM) MSI System, the Company is responsible for jointly financing and
prosecuting the U.S. patent applications for the benefit of the owners and
licensors of this technology. To date, one U.S. patent has issued, two U.S.
patent applications are pending, and two international patent applications are
pending.
RBC-CD4 ELECTROINSERTION TECHNOLOGY PATENTS
Under its license agreement for the RBC-CD4 Electroinsertion
Technology, the Company is responsible for financing and prosecuting patent
applications for the benefit of the owners and licensor of this technology. To
date, two U.S. patent have issued, nine foreign patents have issued and two
foreign patent applications are pending.
LIPOSOME-CD4 TECHNOLOGY PATENTS
Under its license agreement for the Liposome-CD4 Technology, the
Company is responsible for financing and prosecuting patent applications for the
benefit of the owners and licensors of this technology. Currently, one U.S.
patent application is pending, one foreign patent application is pending and
five foreign patent applications have issued.
HIV/AIDS VACCINE PATENTS
Under its license agreements for the HIV/AIDS Vaccine, the Company is
responsible for financing and jointly prosecuting patent applications for the
benefit of the licensor of this technology. Currently, one U.S. patent
application is pending, and one international patent application and one
European patent application has issued.
UGIF TECHNOLOGY PATENTS
Under its license agreement for the UGIF Technology, the Company is
responsible for financing and prosecuting patent applications for the benefit of
the licensor of this technology. Currently, two U.S. patents have issued, one
U.S. patent application is pending, one international patent application is
pending and one Canadian patent has issued.
ION TECHNOLOGY PATENTS
Under its license agreement for the anti-proliferative/growth
regulatory technology, the Company is responsible for financing and jointly
prosecuting patent applications for the benefit of the owners of this
technology. To date, six U.S. patents have issued, five U.S. patent applications
are pending and eight foreign patent applications are pending.
Under its license agreement for the sickle cell technology, the Company
is responsible for financing and jointly prosecuting patent applications for the
benefit of the owners of this technology. To date, two U.S. patents have issued,
four U.S. patent applications are pending and one international application is
pending.
COMPETITION
The Company will compete with approximately 25 other companies involved
in developing and selling respiratory products for the U.S. market. Most of
these companies possess financial and marketing resources and developmental
capabilities substantially greater than the Company. Some of the products in
development by other companies may be demonstrated to be superior to the
Company's current or future products. Furthermore, the pharmaceutical industry
is characterized by rapid technological change and competitors may complete
development and reach the market place prior to the Company. The Company
believes that competition in the respiratory category will be based upon several
factors, including product efficacy, safety, reliability, availability, and
price, among others.
-8-
RECENT BUSINESS DEVELOPMENTS
ZAMBON OPTION AGREEMENT
In April, 1998, the Company entered into an option agreement to form a
strategic arrangement with Zambon Group SpA of Milan, Italy for the worldwide
development and commercialization of drugs to treat respiratory disease with the
Company's proprietary Metered Solution Inhaler ("MSI") system. Terms of the
contemplated agreement will include an equity investment by Zambon in the
Company, funding to develop four respiratory compounds for delivery in the MSI
system, royalties, milestone payments, and retention by the Company of
co-promotion rights for the respiratory drugs in the United States. The Company
will continue to retain all rights to non-respiratory disease applications of
the MSI system.
The option agreement serves the basis upon which the parties will
negotiate a definitive agreement. Zambon is making a $650,000 equity investment
in the Company in connection with the signing of the option agreement.
CONVERTIBLE PREFERRED STOCK OFFERING
The Company completed a $1,250,000 6% redeemable convertible preferred
stock offering with an investor group in April, 1998. Under the terms of this
offering, the preferred stock must be redeemed at the time the Company concludes
a definitive sub-license agreement on the MSI system or other financing.
With proceeds from this transaction, the Company is making the DM
2,000,000 (approximately $1,100,000) payment to Siemens A.G. that was originally
due in January 1998 under the terms of the MSI license agreement.
-9-
EMPLOYEES
As of March 31, 1998, the Company employed 9 persons, five of whom are
executive officers.
CERTAIN RISK FACTORS THAT MAY AFFECT FUTURE RESULTS, FINANCIAL CONDITION AND
MARKET PRICE OF SECURITIES
DEVELOPMENT STAGE COMPANY; HISTORY OF OPERATING LOSSES AND ACCUMULATED
DEFICIT; GOING CONCERN OPINION
The Company is in the development stage. The Company has been
principally engaged to date in research, development and licensing efforts, and
has experienced significant operating losses. The Company experienced operating
losses of $9,489,139 and $7,008,889 for the fiscal years ended December 31, 1997
and 1996 and, as of December 31, 1997, the Company had an accumulated deficit of
$36,077,790. The independent auditors' report dated February 13, 1998, except
for Note 11 as to which the date is April 15, 1998, on the Company's
consolidated financial statements stated that the Company has generated only
minimal operating revenue, has incurred recurring operating losses and requires
additional capital and that these conditions raise substantial doubt about its
ability to continue as a going concern. The Company expects that it will
continue to have a high level of operating expenses and will be required to make
significant up-front expenditures in connection with its product development
activities. As a result, the Company anticipates significant additional
operating losses for 1998 and that such losses will continue thereafter until
such time, if ever, as the Company is able to generate sufficient revenues to
sustain its operations.
The Company's ability to achieve profitable operations is dependent in
large part on regulatory approvals of its products. There can be no assurance
that the Company will ever achieve such approvals or profitable operations.
SIGNIFICANT LIQUIDITY RESTRAINTS
The Company's cash available for funding its operations as of December
31, 1997 was $393,608. As of such date, the Company had trade payables of
$887,782 and current research obligations of $470,768. In addition, committed
and/or anticipated funding of research and development after December 31, 1997
is estimated at approximately $17,500,000. The Company will be required to
obtain additional funds for its business through operations or equity or debt
financings, collaborative arrangements with corporate partners or from other
resources. No assurance can be given that these funds will be available for the
Company to finance its development on acceptable terms, if at all. If adequate
funds are not available from operations or additional sources of funding, the
Company's business will suffer a material adverse effect.
NEED FOR ADDITIONAL FINANCING; UNCERTAINTY OF OBTAINING ADDITIONAL
FUNDING
The Company's operations to date have consumed substantial and
increasing amounts of cash. The negative cash flow from operations is expected
to continue and to accelerate in the foreseeable future. The development of the
Company's technology and proposed products will require a commitment of
substantial funds to conduct costly and time-consuming research, preclinical and
clinical testing, and to bring any such products to market. The Company's future
capital requirements will depend on many factors, including continued progress
in out-licensing the early stage technology and developing the Premaire(TM) MSI
System, the ability of the Company to establish and maintain collaborative
arrangements with others and to comply with the terms thereof, receipt of
payments due from partners under research and development agreements, progress
with preclinical and clinical trials, the time and costs involved in obtaining
regulatory approvals, the cost involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims, the need to acquire licenses to new
technology and the status of competitive products.
The Company needs to raise substantial additional capital to fund its
operations. The Company intends to seek such additional funding through
collaborative or partnering arrangements, the extension of existing
arrangements, or through public or private equity or debt financings. There can
be no assurance that additional financing will be available on acceptable terms
or at all. If additional funds are raised by issuing equity securities, further
dilution to shareholders may result. If adequate funds are not available, the
Company may be required to delay, reduce the scope of, or eliminate one or more
of its research or development programs or obtain funds through arrangements
with collaborative partners or others that may require the Company to relinquish
rights to certain of its technologies, product candidates or products that the
Company would otherwise seek to develop or commercialize. If adequate funds are
not available from operations or additional sources of funding, the Company's
business will suffer a material adverse effect.
-10-
NO COMMERCIALIZATION OF PRODUCTS TO DATE
The Company has not yet begun to generate revenues from the sale of
products. The Company's products will require significant additional
development, clinical testing and investment prior to commercialization. The
Company does not expect regulatory approval for commercial sales of any of its
products in the immediate future. There can be no assurance that such products
will be successfully developed, proven to be safe and efficacious in clinical
trials, able to meet applicable regulatory standards, able to obtain required
regulatory approvals, or produced in commercial quantities at reasonable costs
or be successfully commercialized and marketed.
ROYALTY PAYMENT OBLIGATIONS
The owners and licensors of the technology rights acquired by the
Company are entitled to receive a certain percentage of all royalties and
payments in lieu of royalties received by the Company from commercialization, if
any, of products in respect of which the Company holds licenses. Accordingly, in
addition to its substantial investment in product development, the Company will
be required to make substantial payments to others in connection with revenues
derived from commercialization of products, if any, developed under licenses the
Company holds. Consequently, the Company will not receive the full amount of any
revenues that may be derived from commercialization of products to fund ongoing
operations.
POTENTIAL LOSS OF RIGHTS UPON DEFAULT
Under the terms of existing agreements, the Company is obligated to
make certain payments to its licensors. In the event that the Company defaults
on the payment of an installment under the terms of an existing licensing
agreement, its rights thereunder could be forfeited. As a consequence, the
Company could lose all rights under a license agreement to the related licensed
technology, notwithstanding the total investment made through the date of the
default. There can be no assurance that unforeseen obligations or contingencies
will not deplete the Company's financial resources and, accordingly, sufficient
resources may not be available to fulfill the Company's commitments.
In this regard, in January, 1998 a payment of DM 2.0 million was due to
Siemens AG under the terms of the agreement under which the Company hold the
world-wide marketing rights to the Premaire(TM) MSI System. This payment was not
made until April 15, 1998.
RAPID TECHNOLOGICAL CHANGE; COMPETITION
The medical field is subject to rapid technological change and
innovation. Pharmaceutical and biomedical research and product development are
rapidly evolving fields in which developments are expected to continue at a
rapid pace. Reports of progress and potential breakthroughs are occurring with
increasing frequency. There can be no assurance that the Company will have a
competitive advantage in its fields of technology or in any of the other fields
in which the Company may concentrate its efforts.
The Company's success will depend upon its ability to develop and
maintain a competitive position in the research, development and
commercialization of products and technologies in its areas of focus.
Competition from pharmaceutical, chemical, biomedical and medical companies,
universities, research and other institutions is intense and is expected to
increase. All, or substantially all, of these competitors have substantially
greater research and development capabilities, experience, and manufacturing,
marketing, financial and managerial resources. Further, acquisitions of
competing companies by large pharmaceutical or other companies could enhance
such competitors' financial, marketing and other capabilities. There can be no
assurance that developments by others will not render the Company's products or
technologies obsolete or not commercially viable or that the Company will be
able to keep pace with technological developments.
-11-
GOVERNMENT REGULATION
The Company's ongoing research and development projects are subject to
rigorous FDA approval procedures. The preclinical and clinical testing
requirements to demonstrate safety and efficacy in each clinical indication (the
specific condition intended to be treated) and regulatory approval processes of
the FDA can take a number of years and will require the expenditure of
substantial resources by the Company. Delays in obtaining FDA approval would
adversely affect the marketing of products to which the Company has rights and
the Company's ability to receive product revenues or royalties. Moreover, even
if FDA approval is obtained, a marketed product, its manufacturer and its
manufacturing facilities are subject to continual review and periodic
inspections by the FDA, and a later discovery of previously unknown problems
with a product, manufacturer or facility may result in restrictions on such
product or manufacturer. Failure to comply with the applicable regulatory
requirements can, among other things, result in fines, suspensions of regulatory
approvals, product recalls, operating restrictions and criminal prosecution.
Additional government regulation may be established which could prevent or delay
regulatory approval of the Company's products. Sales of pharmaceutical products
outside the United States are subject to foreign regulatory requirements that
vary widely from country to country. Even if FDA approval has been obtained,
approval of a product by comparable regulatory authorities of foreign countries
must be obtained prior to the commencement of marketing the product in those
countries. The time required to obtain such approval may be longer or shorter
than that required for FDA approval. The Company has no experience in
manufacturing or marketing in foreign countries nor in matters such as currency
regulations, import-export controls or other trade laws. To date, the Company
has not received final regulatory approval from the FDA or any other comparable
foreign regulatory authority in respect of any product or technology.
RISKS INCIDENT TO PATENT APPLICATIONS AND RIGHTS
The Company's success will depend in part on its ability to obtain
patent protection for products and processes and to maintain trade secret
protection and operate without infringing the proprietary rights of others. The
degree of patent protection to be afforded to pharmaceutical, biomedical or
medical inventions is an uncertain area of the law. There can be no assurance
that the Company will develop or receive sublicenses or other rights related to
proprietary technology which are patentable, that any patents pending will
issue, or that any issued patents will provide the Company with any competitive
advantages or will not be challenged by third parties. Furthermore, there can be
no assurance that others will not independently duplicate or develop similar
products or technologies to those developed by or licensed to the Company. If
the Company is required to defend against charges of patent infringement or to
protect its own proprietary rights against third parties, substantial costs will
be incurred and the Company could lose rights to certain products and
technologies.
RELIANCE ON THIRD PARTIES; NO MARKETING OR MANUFACTURING CAPABILITIES
The Company does not currently have its own sales force or an agreement
with another pharmaceutical company to market the Company's products that are in
development. When appropriate, the Company will attempt to build or otherwise
acquire the necessary marketing capabilities to promote its products. There can
be no assurance that the Company will have the resources available to build or
otherwise acquire its own marketing capabilities, or that agreements with other
pharmaceutical companies can be reached to market the Company's products on
terms acceptable to the Company.
In addition, the Company does not intend to manufacture its own
products. While the Company has already entered into two manufacturing and
supply agreements related to the Premaire(TM) MSI System Technology, there can
be no assurance that these manufacturing and supply agreements will be adequate
or that the Company will be able to enter into future manufacturing and supply
agreements on terms acceptable to the Company.
DEPENDENCE UPON OBTAINING HEALTHCARE REIMBURSEMENT
The Company's ability to commercialize human therapeutic and diagnostic
products may indirectly depend in part on the extent to which costs for such
products and technologies are reimbursed by private health insurance or
government health programs. The uncertainty regarding reimbursement may be
especially significant in the case of newly approved products. There can be no
assurance that reimbursement price levels will be sufficient to provide a return
to the Company on its investment in new products and technologies.
-12-
ADEQUACY OF PRODUCT LIABILITY INSURANCE
The use of the Company's proposed products and processes during
testing, and after approval, may entail inherent risks of adverse effects which
could expose the Company to product liability claims and associated adverse
publicity. Although the Company currently maintains general liability insurance,
there can be no assurance that the coverage limits of the Company's insurance
policies will be adequate. The Company currently maintains clinical trial
product liability insurance of $2.0 million per event for certain clinical
trials and intends to obtain insurance for future clinical trials of products
under development. There can be no assurance, however, that the Company will be
able to obtain or maintain insurance for any future clinical trials. Such
insurance is expensive, difficult to obtain and may not be available in the
future on acceptable terms, or at all. A successful claim brought against the
Company in excess of the Company's insurance coverage would have a material
adverse effect upon the Company and its financial condition. The Company intends
to require its licensees to obtain adequate product liability insurance.
However, there can be no assurance that licensees will be able to maintain or
obtain adequate product liability insurance on acceptable terms or that such
insurance will provide adequate coverage against all potential claims.
POTENTIALLY LIMITED TRADING MARKET; POSSIBLE VOLATILITY OF STOCK PRICE.
The Common Stock is listed for trading on American Stock Exchange (the
"AMEX") under the symbol ("SHM"). The Company does not presently satisfy the
listing criteria of the AMEX, including the AMEX requirement that a listed
company that has sustained losses from operations and/or net losses in three of
its four most recent fiscal years have stockholders' equity of at least
$4,000,000. The Company has sustained net losses for its four most recent fiscal
years and, at December 31, 1997, had stockholders' deficit of $(4,637,251). The
failure to meet the AMEX listing criteria may result in the Common Stock no
longer being eligible for listing on the AMEX and trading, if any, of the Common
Stock would thereafter be conducted in the over-the-counter market. If the
Company's Common Stock were to be delisted from the AMEX, it may be more
difficult for investors to dispose of, or to obtain accurate quotations as to
the market value of, the Common Stock.
In the event of the delisting of the Company's Common Stock from the
AMEX, the regulations of the Securities and Exchange Commission ("Commission")
promulgated under the Securities Exchange Act of 1934, as amended ("Exchange
Act"), require additional disclosure relating to the market for penny stocks.
Commission regulations generally define a penny stock to be an equity security
that has a market price of less than $5.00 per share, subject to certain
exceptions. A disclosure schedule explaining the penny stock market and the
risks associated therewith is required to be delivered to a purchaser and
various sales practice requirements are imposed on broker-dealers who sell penny
stocks to persons other than established customers and accredited investors
(generally institutions). In addition, the broker-dealer must provide the
customer with current bid and offer quotations for the penny stock, the
compensation of the broker-dealer and its salesperson in the transaction and
monthly account statements showing the market value of each penny stock held in
the customer's account. If the Company's securities become subject to the
regulations applicable to penny stocks (i.e., by AMEX delisting), the market
liquidity for the Company's securities could be severely affected. In such an
event, the regulations on penny stocks could limit the ability of broker-dealers
to sell the Company's securities and thus the ability of purchasers of the
Company's securities to sell their securities in the secondary market. In the
absence of an active trading market, holders of the Common Stock may experience
substantial difficulty in selling their securities.
VOLATILITY OF MARKET PRICE OF SECURITIES
The market price of securities of firms in the
biotechnology/pharmaceuticals industries have tended to be volatile.
Announcements of technological innovations by the Company or its competitors,
developments concerning proprietary rights and concerns about safety and other
factors may have a material adverse effect on the Company's business or
financial condition. The market price of the Common Stock may be significantly
affected by announcements of developments in the medical field generally or the
Company's research areas specifically. The stock market has experienced
volatility in market prices of companies similar to the Company that has often
been unrelated to the operating results of such companies. This volatility may
have a material adverse effect on the market price of the Common Stock.
-13-
OUTSTANDING OPTIONS, WARRANTS AND CONVERTIBLE SECURITIES; DILUTION
As of December 31, 1997, the Company had reserved approximately
4,781,290 shares of its Common Stock for issuance upon exercise of outstanding,
options, warrants and other securities convertible into shares of its Common
Stock, including shares of Common Stock issuable upon the exercise of options
and warrants held by officers and directors of the Company. In addition as of
December 31, 1997, the Company had $1,551,000 principal amount of Convertible
Debentures and 25,000 shares of Series A Convertible Series A Preferred Stock
outstanding. Each of the convertible securities provide for conversion into
shares of Common Stock of the Company at a discount to the market. The Company
has filed registration statements with the Commission covering the resale of
substantially all of the shares of Common Stock underlying such options,
warrants and other securities. The exercise of options and outstanding warrants,
the conversion of such other securities and sales of Common Stock issuable
thereunder could have a significant dilutive effect on the market price of
shares of the Company's Common Stock and could materially impair the Company's
ability to raise capital through the future sale of its equity securities.
AUTHORIZATION OF SERIES A PREFERRED STOCK
The Company's Certificate of Incorporation authorizes the issuance of
"blank check" preferred stock with such designations, rights and preferences as
may be determined from time to time by the Board of Directors, without
shareholder approval. In the event of issuance, such preferred stock could be
utilized, under certain circumstances, as a method of discouraging, delaying or
preventing a change in control of the Company and preventing shareholders from
receiving a premium for their shares in connection with a change of control.
Except for the issuance of shares of the Company's Series A Cumulative
Convertible Redeemable Preferred Stock that occurred in connection with the
consummation of a private placement in February 1997, the Company has no present
intention to issue any shares of its preferred stock; however, there can be no
assurance that the Company will not issue additional shares of its preferred
stock in the future.
ITEM 2. PROPERTIES
The Company's principal executive offices are located at 425 South
Woodsmill Road, St. Louis, Missouri 63017. These premises consist of
approximately 4,521 square feet subject to a lease that expires September 14,
2002. The monthly rent for these premises is $9,042. The Company also maintains
a small office at 37 S. Main Street, Pittsford, New York (for a monthly rent of
$800). The lease on the Pittsford office expires in less than a year. The
Company maintains no laboratory, research or other facilities, but conducts
research and development in outside laboratories under contracts with
universities. The Company believes that its existing office arrangements will be
adequate to meet its reasonably foreseeable needs.
ITEM 3. LEGAL PROCEEDINGS
The Company is a defendant in DR. BONNIE S. DUNBAR V. E/J DEVELOPMENT
CORPORATION, U-TECH MEDICAL CORPORATION, SHEFFIELD MEDICAL TECHNOLOGIES, INC.
AND DOUGLAS R. EGER, No. 97-28899, in the District Court of Harris County, Texas
(133rd Judicial District). The plaintiff in this action asserts breach of
contract, fraud and a claim for quantum meruit relating principally to certain
stock options exercisable for a total of 40,000 shares of Common Stock issued in
1992 and 1993 to the plaintiff in consideration of consulting and research
services provided to the Company. The plaintiff served as the principal
investigator at Baylor College of Medicine in Houston, Texas on an ovarian
cancer research project that was funded for several years by the Company. The
plaintiff seeks actual damages against Sheffield and the other defendants,
including Douglas R. Eger, a former Chairman of the Company, together with
punitive damages, attorneys' fees, costs and expenses of the lawsuit, and pre-
and post-judgment interest. The Company has denied the plaintiff's allegations
and is vigorously contesting this action. This action is currently in the
discovery phase. The Company and the plaintiff have engaged in settlement
discussions, but no agreement has been reached to date. The Company is currently
unable predict the likely outcome of this action. However, an unfavorable
decision could have a material adverse effect on the business and financial
condition of the Company.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
-14-
PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS.
The following table sets forth the high and low sale prices of the
Company's Common Stock on the American Stock Exchange (the "AMEX") for the
periods indicated.
1997 HIGH LOW
---- ---
Fourth Quarter...................... $2.50 $1.125
Third Quarter....................... $3.00 $2.00
Second Quarter...................... $3.375 $2.25
First Quarter....................... $3.75 $2.625
1996:
Fourth Quarter...................... $4.125 $3.125
Third Quarter....................... $4.625 $3.0625
Second Quarter...................... $6.50 $4.00
First Quarter....................... $6.75 $3.5625
The closing sale price for the Company's Common Stock on the AMEX on
March 31, 1998 was $0.6875 per share. At March 31, 1998, there were
approximately 390 holders of record of the Company's Common Stock.
The Company has never paid dividends on its Common Stock and does not
intend to pay cash dividends on its Common Stock in the foreseeable future. The
terms of the Company's Series A Cumulative Convertible Redeemable Preferred
Stock generally prohibit the payment of cash dividends and other distributions
on the Company's Common Stock unless full cumulative stock dividends on shares
of such Series A Common Stock have been paid or declared in full.
The following unregistered securities were issued by the Company during
the quarter ended December 31, 1997:
Number of Shares
Sold/Issued/ Offering/
Date of Description of Subject to Options Exercise Price
Sale/Issuance Securities Issued or Warrants per share ($) Purchaser or Class
October 1997 Common Stock 92,895 1 7/8 Holders of Series A
Preferred Stock
November - Stock Options 146,000 1 1/2 - 4 1/2 Issuances to employees
December 1997 pursuant to 1993 Stock
Option Plan
December 1997 Common Stock 44,769 1 3/16 Holders of Series A
Preferred Stock
The issuance of these securities are claimed to be exempt from registration
pursuant to Section 4(2) of the Securities Act of 1933, as amended, as
transactions by an issuer not involving a public offering. There were no
underwriting discounts or commissions paid in connection with the issuance of
any of these securities.
-15-
ITEM 6. SELECTED FINANCIAL DATA
SELECTED FINANCIAL INFORMATION
(IN DOLLARS, EXCEPT PER SHARE INFORMATION
YEARS ENDED DECEMBER 31,
1997 1996 1995 1994 1993
------------------------------------------------------------------------------------
STATEMENT OF
OPERATIONS
DATA:
Sublicense and $ 556,914 $ 673,664 $ 80,610 $ 63,290 $ 81,671
interest income
Operating costs and
expenses
Research and 5,379,193 3,841,818 4,424,154 3,989,838 2,134,330
development
General and 4,666,859 3,840,735 3,044,173 2,393,082 1,823,631
administrative
Total operating 10,046,052 7,682,553 7,468,327 6,382,920 3,957,961
costs and expenses
Loss from operations $ (9,489,138) $ (7,008,889) $ (7,387,717) $ (6,319,630) $(3,876,290)
Loss per share of common stock - $ (0.80) $ (0.65) $ (0.90) $ (0.96) $ (0.75)
basic
Weighted average common shares 11,976,090 10,806,799 8,185,457 6,596,227 5,169,830
outstanding
BALANCE SHEET DATA:
Working capital (net) $ (837,564) $ 1,433,773 $ 1,585,675 $ (799,629) $ 1,570,183
Total assets 689,937 2,773,884 2,221,050 371,073 1,834,560
Long-term obligations and 4,019,263 27,206 -- -- --
redeemable preferred stock
Accumulated deficit (36,157,290) (26,588,652) (19,579,763) (12,192,046) (5,872,416)
Shareholders' equity (net capital (4,637,251) 1,695,837 1,792,363 (573,853) 1,673,113
deficiency)
No cash dividends have been paid for any of the periods presented.
Net loss per share is based upon the weighted average number of common and
certain common equivalent shares outstanding.
See consolidated financial statements and accompanying footnotes.
-16-
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATION.
THIS REPORT CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS WITHIN THE
MEANING OF SECTION 27A OF THE SECURITIES ACT OF 1933, AS AMENDED, AND SECTION
21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, WHICH ARE INTENDED TO BE
COVERED BY THE SAFE HARBORS CREATED HEREBY. ALL FORWARD-LOOKING STATEMENTS
INVOLVE RISKS AND UNCERTAINTY, INCLUDING WITHOUT LIMITATION, RISKS SET FORTH
ABOVE UNDER BUSINESS - CERTAIN RISK FACTORS THAT MAY AFFECT FUTURE RESULTS,
FINANCIAL CONDITION AND MARKET PRICE OF SECURITIES".
THE DISCUSSION AND ANALYSIS BELOW SHOULD BE READ IN CONJUNCTION WITH
THE FINANCIAL STATEMENTS OF THE COMPANY AND THE RELATED NOTES TO FINANCIAL
STATEMENTS INCLUDED ELSEWHERE HEREIN.
OVERVIEW
Sheffield Medical Technologies Inc. ("Sheffield") was incorporated on
October 17, 1986. The Company's wholly-owned subsidiary, U-Tech Medical
Corporation ("U-Tech") was incorporated on January 13, 1992 and was liquidated
on June 30, 1997. On January 10, 1996, Ion Pharmaceuticals, Inc. ("Ion"), was
formed as a wholly-owned subsidiary of the Company. At that time, Ion acquired
the Company's rights to certain early-stage biomedical technologies. On April
17, 1997, CP Pharmaceuticals, Inc. ("CP") was formed for the purpose of
acquiring Camelot Pharmacal, L.L.C., a privately held pharmaceutical development
company, which acquisition was consummated on April 25, 1997.
The Company is in the development stage and to date has been principally
engaged in research, development and licensing efforts. The Company has
generated minimal operating revenue and requires additional capital which the
Company intends to obtain through out-licensing as well as through equity and
debt offerings to continue to operate its business. The Company's ability to
meet its obligations as they become due and to continue as a going concern must
be considered in light of the expenses, difficulties and delays frequently
encountered in developing a new business, particularly since the Company will
focus on research, development and unproven technology that may require a
lengthy period of time and substantial expenditures to complete. Even if the
Company is able to successfully develop new products, there can be no assurance
that the Company will generate sufficient revenues from the sale or licensing of
such products to be profitable. Management believes that the Company's ability
to meet its obligations as they become due and to continue as a going concern
through December 1998 is dependent upon obtaining additional financing. Until
such financing is obtained, the Company must rely on short-term loans from its
officers in order to meet certain of its obligations.
FISCAL YEARS ENDED DECEMBER 31, 1997, 1996 AND 1995
In 1997, the Company signed a sub-license agreement for certain
early-stage technologies and earned sub-license fees that are included in
revenue. Interest income was $56,914 for the year ended December 31, 1997
compared to $163,664 and $80,610 for the years ended December 31, 1996 and 1995,
respectively. The decrease in 1997 interest income of $106,750 compared to 1996
was due primarily to use of funds available for investment as a result of the
acquisition of the Premaire(TM) MSI System from Siemens AG. The increase in 1996
interest income of $83,054, compared to 1995, was due primarily to the increase
in the amount of funds available for investment as the result of the completion
of the Company's warrant discount program completed in 1996, which raised total
gross proceeds of $5.6 million.
Research and product development expenses were $3,729,193 for the year
ending December 31, 1997 compared to $3,841,818 and $4,424,154 for the years
ended December 31, 1996 and 1995, respectively. The 1997 decrease of $112,625
was attributable to the winding down of the early-stage technology projects. In
1997, the Company entered into two (2) major research and development
agreements. The Company sub-licensed certain technology to a subsidiary of
Imutec Pharma Inc. in exchange for cash, milestone payments, transfer of
research expenses to Imutec and a twenty percent (20%) ownership interest upon
commercialization. The Siemens AG agreement, and related development expenses
incurred relative to the Premaire(TM) MSI System, resulted in funds expended of
a total of $1,800,440 in 1997. The 1996 decrease of $582,336 in research and
development costs were attributable to negotiating extensions of two major
Sponsored Research Agreements signed in October 1996 and the winding down of the
RBC-CD4 Electroinsertion Technology project, partially offset by the increased
development of the Ion Anti-Proliferative technology projects.
General and administrative expenses were $4,627,567 for the year ending
December 31, 1997 compared to $3,831,204 and $2,979,437 for the years ended
December 31, 1996 and 1995, respectively. The 1997 increase of $796,363 was
primarily due to an increased number management salaries resulting from the
Camelot acquisition, compensation expense associated with extension of certain
option and warrant agreements, and expenses related to the two financings
completed during the year. The 1996 increase of $851,767 primarily resulted from
the one-time cashless exercise of options and warrants by a former employee of
the Company, totaling $562,912, and private placement professional fees relating
to Ion.
Acquisition of in-process technology charges of $1,650,000 relate to
the April 25, 1997 acquisition of Camelot Pharmacal, L.L.C.
-17-
Interest expense was $39,292 for the year ending December 31, 1997
compared with $9,531 and $64,736 for the years ended December 31, 1996 and 1995,
respectively. The 1997 increase of $29,761 was attributable to the 6%
convertible debentures issued during the year. The 1996 decrease of $55,205 was
due to satisfaction in full of the Company's $550,000 loan from SMT Investment
Partnership in 1995.
As a result of the above, net loss for 1997 was $9,489,138 compared to
$7,008,889 and $7,387,717 for the years ending December 31, 1996 and 1995,
respectively.
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, the Company has financed its operations primarily
through the sale of securities, from which it has raised an aggregate of
approximately $28 million through December 31, 1997. On February 28, 1997, the
Company closed a private offering of 35,000 shares of its 7% Series A Cumulative
Convertible Redeemable Preferred Stock, which raised total gross proceeds of
$3.5 million. The proceeds of this offering were used to fund research and
development, patent prosecution and for working capital and general corporate
purposes.
In addition, in April 1998 the Company completed two agreements that
provided additional capital. The first provided the Company with $650,000 in
gross proceeds from the sale of the Company's Common Stock. The second provided
the Company with $1,250,000 in gross proceeds from the sale of the Company's
Series B Convertible Redeemable Preferred Stock.
From inception through December 31, 1997, the Company earned $453,827
in interest on cash, cash equivalents and short-term investments. The Company
invests excess cash in cash equivalents and short-term investments in a cash
management account that invests in U.S. government securities and high grade
corporate investments.
Net cash used in development stage activities was $6,677,405 for the
year ended December 31, 1997 compared with $6,043,876, $7,541,937 and
$30,198,450 for the years ended December 31, 1996 and 1995, and from inception
in 1986 through 1997, respectively. Cash of $3,284,812, $6,420,834, $9,346,901
and $27,955,005 was provided by the issuance of securities in 1997, 1996, 1995
and from inception in 1986 through 1997, respectively.
The Company's total assets were $689,937 at December 31, 1997 compared
with $2,773,884 at December 31, 1996. The 1997 decrease of $2,083,947 was
primarily attributable to expenditures related to the acquisition and
development of the Premaire(TM) MSI System technology. The Company's liabilities
at December 31, 1997, consisting of accounts payable, sponsored research,
capital lease obligations and the 6% convertible debenture, were $2,938,425
compared with $1,078,047 at December 31, 1996.
The Company spent approximately $19.3 million through December 31, 1997
to fund certain ongoing technology research projects and expects to incur
additional costs in the future, including costs relating to its ongoing
sponsored research and development activities, and preclinical and clinical
testing of its product candidates. The Company may also bear considerable costs
in connection with filing, prosecuting, defending and/or enforcing its patent
and other intellectual property claims. Therefore, the Company will need
substantial additional capital before it will recognize significant cash flow
from operations, which is contingent on the successful commercialization of the
Company's technologies. There can be no assurance that any of the technologies
to which the Company currently has or may acquire rights to can or will be
commercialized or that any revenues generated from such commercialization will
be sufficient to fund existing and future research and development activities.
While the Company does not believe that inflation has had a material
impact on its results of operations, there can be no assurance that inflation in
the future will not impact financial markets which, in turn, may adversely
affect the Company's valuation of its securities and, consequently, its ability
to raise additional capital, either through equity or debt instruments, or any
off-balance sheet refinancing arrangements, such as collaboration and licensing
agreements with other companies.
Because the Company does not expect to generate significant cash flows
from operations for at least several years, the Company believes it will require
additional funds to meet future costs. The Company will attempt to meet its
capital requirements with existing cash balances and through additional public
or private offerings of its securities, debt financing, and collaboration and
licensing arrangements with other companies. There can be no assurance that the
Company will be able to obtain such additional funds or enter into such
collaborative and licensing arrangements on terms favorable to the Company, if
at all. The Company's development programs may be curtailed if future financings
are not completed.
-18-
The table below indicates (i) the Company's direct research and
development expenses by project for the fiscal year ended December 31, 1997 and
from the Company's inception to December 31, 1997, (ii) the Company's current
estimate by project of committed and/or anticipated funding requirements after
December 31, 1997 and (iii) revenues received to date by project.
DIRECT RESEARCH AND DEVELOPMENT EXPENSES
(IN DOLLARS)
R&D PROJECT Fiscal year Inception to Committed and/or Revenue
ended 12/31/97 12/31/97 Anticipated R&D Received
Funding After
12/31/97*
Multi-Dose Solution Inhaler 1,800,440 1,944,848 17,500,000** 0
(MSI System)
Ion Pharmaceuticals, 1,014,031 4,822,595 0 510,000
Inc. Technologies
RBC-CD4 Electroinsertion 15,760 6,254,185 0 0
Technology
Liposome-CD4 Technology 0 2,322,322 0 500,000
HIV/AIDS Vaccine 137,500 1,211,618 0 0
UGIF Technology 120,036 223,437 0 0
Membrane Attack Complex 243,744 365,618 0 0
(MAC)/Complement
Technology
- -----------------
* These figures include management's estimates of anticipated direct R&D
funding as of the date of this report. The amounts and rate of
application of the Company's funds to any particular project are
expected to fluctuate and will depend in part on the Company's
successful completion of various stages of research, the availability
of additional financing and the Company's identification and
acquisition of rights in new technologies in the future.
** Will be zero dollars in the event Zambon exercises its option agreement
on the MSI respiratory applications.
The Company has conducted a review of its computer systems to identify
the systems that could be affected by the "Year 2000" issue. The Year 2000
problem is the result of computer programs being written using two digits
(rather than four) to define the applicable year. Any of the Company's programs
that have time-sensitive software may recognize a date using "00" as the year
1900 rather than the year 2000. This could result in a major system failure or
miscalculations. The Company presently believes that the Year 2000 problem will
not pose significant operational problems for the Company's computer systems.
Additionally, the cost of the Year 2000 problem will have no material impact on
the operations of the Company.
-19-
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
Not applicable.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
See page F-1.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
Not applicable.
-20-
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS;
COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT
The information required by this item is incorporated by reference from
the Company's definitive proxy statement to be filed not later than April 30,
1998 pursuant to Regulation 14A of the General Rules and Regulations under the
Securities Exchange Act of 1934 ("Regulation 14A").
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated by reference from
the Company's definitive proxy statement to be filed not later than April 30,
1998 pursuant to Regulation 14A.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The information required by this item is incorporated by reference from
the Company's definitive proxy statement to be filed not later than April 30,
1998 pursuant to Regulation 14A.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The information required by this item is incorporated by reference from
the Company's definitive proxy statement to be filed not later than April 30,
1998 pursuant to Regulation 14A.
-21-
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a)(1) Financial Statements
The following Financial Statements are included:
Report of Independent Auditors
Consolidated Balance Sheets as of
December 31, 1997 and 1996
Consolidated Statements of Operations for the years
ended December 31, 1997, 1996 and 1995 and for
the period October 17, 1986 (inception) to
December 31 1997
Consolidated Statements of Stockholders' Equity (net
capital deficiency) for the period from October 17,
1986 (inception) to December 31 1997
Consolidated Statements of Cash Flows for the years
ended December 31, 1997, 1996 and 1995 and for
the period from October 17, 1986 (inception) to
December 31 1997
Notes to Financial Statements
(a)(2) Financial Statement Schedules
All financial statement schedules are omitted because they are
not applicable, or not required, or because the required information is included
in the financial statements or notes thereto.
(a)(3) Exhibits:
NO. REFERENCE
3.1 Certificate of Incorporation of the Company, as amended (4)
3.2 By-Laws of the Company (4)
4.1 Form of Common Stock Certificate (2)
4.2 Certificate of Designation defining the powers, designations, (7)
rights, preferences, limitations and restrictions applicable to the
Company's Series A Cumulative Convertible Redeemable
Preferred Stock
10.1 Employment Agreement dated as of October 1, 1995 between (2)
the Company and Douglas R. Eger
10.2 Employment Agreement dated as of September 7, 1995 (2)
between the Company and George Lombardi
10.3 Amendment dated as of September 22, 1996 to Employment (7)
Agreement dated as of September 7, 1995 between the
Company and George Lombardi
10.4 Employment Agreement dated as of March 28, 1996 between (2)
the Company and Michael Zeldin
10.5 Amendment dated June 6, 1996 to Employment Agreement (7)
dated as of March 28, 1996 between the Company and Michael
Zeldin
10.6 Employment Agreement dated as of June 6, 1996 between the (3)
Company and Thomas M. Fitzgerald
10.65 Employment Agreement dated as of November 17, 1997 (1)
between the Company and Judy Roeske Bullock
10.7 Agreement of Sublease dated as of November 17, 1995 (2)
between the Company and Brumbaugh Graves Donohue &
Raymond relating to 30 Rockefeller Plaza, Suite 4515, New
York, New York
10.8 1993 Stock Option Plan, as amended (1)
10.9 1993 Restricted Stock Plan, as amended (2)
10.10 1996 Directors Stock Option Plan (7)
10.11 Agreement and Plan of Merger among the Company, Camelot (6)
Pharmacal, L.L.C., David A. Byron, Loren G. Peterson and
Carl Siekmann dated April 25, 1997
10.12 Employment Agreement dated as of April 25, 1997 between the (6)
Company and David A. Byron
10.13 Employment Agreement dated as of April 25, 1997 between (6)
the Company and Loren G. Peterson
10.14 Employment Agreement dated as of April 25, 1997 between the (6)
Company and Carl Siekmann
10.15 Form of the Company's 6% Convertible Subordinated (8)
Debentures due September 22, 2000.
-22-
NO. REFERENCE
10.16 Lease dated August 18, 1997 between Corporate Center, L.L.C. (5)
and the Company relating to the lease of office space in St.
Louis, Missouri.
10.17 Assignment and License Agreement dated as of December 3, (9)
1997 between 1266417 Ontario Limited and Ion
Pharmaceuticals, Inc. (portions of this exhibit are omitted and
were filed separately with the Securities Exchange Commission
pursuant to the Company's application requesting confidential
treatment in accordance with Rule 24b-2 as promulgated under
the Securities Exchange Act of 1934, as amended).
10.18 Sub-License Agreement dated as of December 3, 1997 (9)
between 1266417 Ontario Limited and Ion Pharmaceuticals,
Inc. (portions of this exhibit are omitted and were filed
separately with the Securities Exchange Commission pursuant
to the Company's application requesting confidential treatment
in accordance with Rule 24b-2 as promulgated under the
Securities Exchange Act of 1934, as amended).
10.19 Severance Agreement dated December 24, 1997 between the (1)
Company and Douglas R. Eger.
10.20 Severance Agreement dated October 15, 1997 between the (1)
Company and George Lombardi.
21 Subsidiaries of Registrant (1)
23.1 Consent of Ernst & Young LLP (1)
23.2 Consent of KPMG Peat Marwick LLP (1)
27 Financial Data Schedule (1)
- ----------------------------
(1) Filed herewith.
(2) Incorporated by reference to the Company's Annual Report on Form 10-KSB
for its fiscal year ended December 31, 1995 filed with the Securities
and Exchange Commission.
(3) Incorporated by reference to the Company's Quarterly Report on Form
10-QSB for the quarter ended June 30, 1996 filed with the Securities
and Exchange Commission.
(4) Incorporated by reference to the Company's Quarterly Report on Form
10-Q for the quarter ended June 30, 1997 filed with the Securities and
Exchange Commission.
(5) Incorporated by reference to the Company's Quarterly Report on Form
10-Q for the quarter ended September 30, 1997 filed with the Securities
and Exchange Commission.
(6) Incorporated by reference to the Company's Quarterly Report on Form
10-Q for the quarter ended March 31, 1997 filed with the Securities and
Exchange Commission.
(7) Incorporated by reference to the Company's Annual Report on Form 10-KSB
for the year ended December 31, 1996 filed with the Securities and
Exchange Commission.
(8) Incorporated by reference to the Company's Registration Statement on
Form S-3 (File No. 333-38327) filed with the Securities and Exchange
Commission on October 21, 1997.
(9) Incorporated by reference to the Company's Current Report on Form 8-K
filed with the Securities and Exchange Commission on December 17, 1997.
(b) Reports on Form 8-K:
The Company filed a Current Report on Form 8-K with the Securities and
Exchange Commission on December 17, 1997 relating to the Company's sale of
certain patent and other proprietary interests.
-23-
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
SHEFFIELD PHARMACEUTICALS, INC.
Dated: April 15, 1998 /s/ Loren G. Peterson
------------------------------
Loren G. Peterson
President and Chief Executive Officer
POWER OF ATTORNEY
Sheffield Pharmaceuticals, Inc. and each of the undersigned do hereby
appoint Loren G. Peterson and Thomas Fitzgerald and each of them severally, its
or his or her true and lawful attorney to execute on behalf of Sheffield
Pharmaceuticals, Inc. and the undersigned any and all amendments to this Annual
Report and to file the same with all exhibits thereto and other documents in
connection therewith, with the Securities and Exchange Commission; each of such
attorneys shall have the power to act hereunder with or without the other.
In accordance with the Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Registrant in the
capacities and on the dates indicated.
Signature Title Date
--------- ----- ----
/s/ Thomas M. Fitzgerald Chairman and Director April 15, 1998
- --------------------------------------
Thomas M. Fitzgerald
/s/ Loren G. Peterson Director, President and Chief April 15, 1998
- -------------------------------------- Executive Officer
Loren G. Peterson
/s/ John M. Bailey Director April 15, 1998
- --------------------------------------
John M. Bailey
/s/ Digby W. Barrios Director April 15, 1998
- --------------------------------------
Digby W. Barrios
/s/ Douglas R. Eger Director April 15, 1998
- --------------------------------------
Douglas R. Eger
/s/ Judy Roeske Bullock Vice President, Chief April 15, 1998
- -------------------------------------- Financial Officer,
Judy Roeske Bullock Treasurer and Secretary (Chief Financial
and Chief Accounting Officer)
-24-
SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES
(a development stage enterprise)
Table of Contents
Page
----
Consolidated Financial Statements
Reports of Independent Auditors .....................................F-2
Consolidated Balance Sheets as of December 31, 1997 and 1996.........F-4
Consolidated Statements of Operations
for the three years in the period
ended December 31, 1997 and for the period from
October 17, 1986 (inception) to December 31, 1997 ..............F-5
Consolidated Statements of Stockholders'
Equity (Net Capital Deficiency)
for the period from October 17, 1986 (inception) to
December 31, 1997 ..............................................F-6
Consolidated Statements of Cash Flows
for the three years in the period
ended December 31, 1997 and for the period from
October 17, 1986 (inception) to December 31, 1997...............F-7
Notes to Consolidated Financial Statements ..........................F-8
F-1
Report of Independent Auditors
The Board of Directors and Stockholders
Sheffield Pharmaceuticals, Inc.
We have audited the accompanying consolidated balance sheets of Sheffield
Pharmaceuticals, Inc. (formerly known as Sheffield Medical Technologies Inc.)
and subsidiaries (a development stage enterprise) as of December 31, 1997 and
1996, and the related consolidated statements of operations, stockholders'
equity (net capital deficiency), and cash flows for each of the three years in
the period ended December 31, 1997 and for the period October 17, 1986
(inception) through December 31, 1997. 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. The consolidated
financial statements as of December 31, 1993, and for the period October 17,
1986 (inception) through December 31, 1993, were audited by other auditors whose
report dated February 11, 1994 expressed an unqualified opinion on those
statements and included an explanatory paragraph that stated that the Company's
"recurring losses and net deficit position raise substantial doubt about its
ability to continue as a going concern. The 1993 financial statements do not
include any adjustments that might result from the outcome of this uncertainty."
The consolidated financial statements for the period October 17, 1986
(inception) through December 31, 1993 include cumulative net losses of
$5,872,416. Our opinion on the consolidated statements of operations,
stockholders' equity (net capital deficiency) and cash flows for the period
October 17, 1986 (inception) through December 31, 1997, insofar as it relates to
amounts for prior periods through December 31, 1993, is based solely on the
report of other auditors.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards 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. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits and the report of other auditors provide a reasonable
basis for our opinion.
In our opinion, based on our audits, and for the period October 17, 1986
(inception) through December 31, 1993, the report of other auditors, the
financial statements referred to above present fairly, in all material respects,
the consolidated financial position of Sheffield Pharmaceuticals, Inc. and
subsidiaries at December 31, 1997 and 1996, and the consolidated results of
their operations and their cash flows for each of the three years in the period
ended December 31, 1997 and the period from October 17, 1986 (inception) through
December 31, 1997, in conformity with generally accepted accounting principles.
The accompanying consolidated financial statements have been prepared assuming
that Sheffield Pharmaceuticals, Inc. and subsidiaries will continue as a going
concern. As more fully described in Note 1, the Company has generated only
minimal operating revenue, has incurred recurring operating losses and requires
additional capital. These conditions raise substantial doubt about the Company's
ability to continue as a going concern. The consolidated financial statements do
not include any adjustments that might result from the outcome of this
uncertainty.
Princeton, New Jersey
February 13, 1998 except for Note 11
as to which the date is April 15, 1998
F-2
Independent Auditors' Report
The Board of Directors and Stockholders
Sheffield Medical Technologies Inc.:
We have audited the accompanying consolidated statements of operations,
stockholders' equity (net capital deficiency) and cash flows of Sheffield
Medical Technologies Inc. and subsidiary (a development stage enterprise) for
the period from October 17, 1986 (inception) to December 31, 1993 (not included
separately herein). 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 conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit also includes assessing the accounting principles used
and significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above presents
fairly, in all material respects, the results of Sheffield Medical Technologies
Inc. and subsidiary's operations and cash flows for the period from October 17,
1986 (inception) to December 31, 1993 in conformity with generally accepted
accounting principles.
The accompanying consolidated financial statements have been prepared assuming
that the Company will continue as a going concern. As reflected in the
accompanying consolidated financial statements, the Company's recurring losses
raise substantial doubt about its ability to continue as a going concern.
Management's plans in regard to these matters were described in note 8 to the
December 31, 1993 financial statements (not included separately herein). The
consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Houston, Texas
February 11, 1994
F-3
SHEFFIELD PHARMACEUTICALS, INC. AND SUBSIDIARIES
(a development stage enterprise)
Consolidated Balance Sheets
December 31,
1997 1996
------------ ------------
Assets
Current assets:
Cash and cash equivalents $ 393,608 $ 1,979,871
Marketable securities -- 460,768
Loan receivable - former officer 80,000 --
Prepaid expenses and other current assets 47,378 43,975
------------ ------------
Total current assets 520,986 2,484,614
------------ ------------
Property and equipment:
Laboratory equipment 185,852 185,852
Office equipment 142,562 89,019
Leasehold improvements -- 61,390
------------ ------------
328,414 336,261
Less accumulated depreciation and amortization 185,201 162,007
------------ ------------
Net property and equipment 143,213 174,254
------------ ------------
Segregated cash -- 75,000
Other assets 25,738 40,016
------------ ------------
Total assets $ 689,937 $ 2,773,884
============ ============
Liabilities and Stockholders' Equity (Net Capital Deficiency)
Current liabilities:
Accounts payable and accrued liabilities $ 887,782 $ 446,965
Sponsored research payable 470,768 580,157
Capital lease obligation-current portion -- 23,719
------------ ------------
Total current liabilities 1,358,550 1,050,841
Capital lease obligation - non-current portion -- 27,206
6% convertible subordinated debenture 1,551,000 --
Interest Payable on 6% convertible subordinated debenture 28,875 --
Cumulative convertible redeemable preferred stock, $.01 par value. Authorized,
3,000,000 shares; issued and outstanding, 25,000 and 0 shares at
December 31, 1997 and 1996, respectively 2,468,263 --
Additional paid-in capital associated with cumulative convertible
redeemable preferred stock 2,249,145 --
Stock dividends payable on preferred stock 139,368 --
Commitments and contingencies
Stockholders' equity (net capital deficiency):
Common stock, $.01 par value. Authorized, 50,000,000 shares;
issued and outstanding, 12,649,539 and 11,388,274
shares at December 31, 1997 and 1996, respectively 126,495 113,883
Notes receivable in connection with sale of stock (72,600) (110,000)
Additional paid-in capital 31,386,644 28,319,838
Unrealized loss on marketable securities -- (39,232)
Deficit accumulated during development stage (36,157,290) (26,588,652)
------------ ------------
(4,716,751) 1,695,837
------------ ------------
Total liabilities and stockholders' equity (net capital deficiency) $ 689,937 $ 2,773,884