e10ksb
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-KSB
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period
from to |
Commission File Number: 000-49616
Halozyme Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Nevada
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88-0488686 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
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11588 Sorrento Valley Road, Suite 17,
San Diego, California
(Address of principal executive offices) |
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92121
(Zip Code) |
(858) 794-8889
(Registrants Telephone Number, Including Area Code)
Securities registered under Section 12(b) of the Act:
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Title of Each Class Registered: |
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Name of Each Exchange on Which Registered: |
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None
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None |
Securities registered under Section 12(g) of the Act:
Common Stock, Par Value $.001
(Title of Class)
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 of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers in
response to Item 405 of Regulation S-B is not
contained in this form, and no disclosure will be contained, to
the best of registrants knowledge, in definitive proxy or
information statements incorporated by reference in
Part III of this Form 10-KSB or any amendment to this
Form 10-KSB. No o
State issuers revenues for its most recent fiscal year: $0.
State the aggregate market value of the voting and non-voting
common equity held by non-affiliates computed by reference to
the price at which the common equity was sold, or the average
bid and asked price of such common equity, as of a specified
date within the past 60 days. (See definition of affiliate
in Rule 12b-2 of the Exchange Act.) As of February 15,
2005, approximately $91,522,400.
As of February 15, 2005, there were 49,502,083 shares
of the issuers $.001 par value common stock issued
and outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the issuers Definitive Proxy Statement to be
filed with the Commission pursuant to Regulation 14A in
connection with the registrants 2005 Annual Meeting of
Stockholders, to be filed subsequent to the date hereof, are
incorporated by reference into Parts II and III of
this Annual Report. Such Definitive Proxy Statement will be
filed with the Securities and Exchange Commission not later than
120 days after the conclusion of the issuers fiscal
year ended December 31, 2004.
Transitional Small Business Disclosure format (check
one): Yes þ No o
PART I
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Item 1. |
Description of Business. |
This Annual Report contains forward-looking statements
regarding our business, financial condition, results of
operations and prospects. Words such as expects,
anticipates, intends, plans,
believes, seeks, estimates
and similar expressions or variations of such words are intended
to identify forward-looking statements, but are not the
exclusive means of identifying forward-looking statements in
this Annual Report. Additionally, statements concerning future
matters such as the development or regulatory approval of new
products, enhancements of existing products or technologies,
revenue and expense levels and other statements regarding
matters that are not historical are forward-looking
statements.
Although forward-looking statements in this Annual Report
reflect the good faith judgment of our management, such
statements can only be based on facts and factors currently
known by us. Consequently, forward-looking statements are
inherently subject to risks and uncertainties and actual results
and outcomes may differ materially from the results and outcomes
discussed in or anticipated by the forward-looking statements.
Factors that could cause or contribute to such differences in
results and outcomes include without limitation those discussed
under the heading Risk Factors below, as well as
those discussed elsewhere in this Annual Report. Readers are
urged not to place undue reliance on these forward-looking
statements, which speak only as of the date of this Annual
Report. We undertake no obligation to revise or update any
forward-looking statements in order to reflect any event or
circumstance that may arise after the date of this Annual
Report. Readers are urged to carefully review and consider the
various disclosures made in this Annual Report, which attempt to
advise interested parties of the risks and factors that may
affect our business, financial condition, results of operations
and prospects.
The Company
We are a development stage biopharmaceutical company dedicated
to the development and commercialization of recombinant human
enzymes for the infertility, ophthalmology, and oncology
markets. Our operations to date have been limited to organizing
and staffing the Company, acquiring, developing and securing its
technology and undertaking product development for a limited
number of product candidates. As the Company has not begun
principal operations of commercializing a product candidate, the
financial statements have been presented as a development stage
company.
DeliaTroph Pharmaceuticals, Inc. (DeliaTroph), our
predecessor company, was incorporated on February 26, 1998.
Effective March 11, 2004, DeliaTroph (which was doing
business at the time as Hyalozyme Therapeutics, Inc.), Global
Yacht Services, Inc. (Global), a publicly traded
Nevada corporation and Hyalozyme Acquisition Corporation
(Merger Sub), a wholly owned subsidiary of Global,
completed a transaction in which Merger Sub merged with and into
DeliaTroph (the Merger), with DeliaTroph surviving
as a wholly owned subsidiary of Global.
Although Global acquired DeliaTroph as a result of the Merger,
the former shareholders of DeliaTroph received a majority of the
voting interest in the combined enterprise as consideration for
entering into the Merger. Additionally, the Merger resulted in
DeliaTrophs management and Board of Directors assuming
operational control of Global.
The following summary lists the structure of the Merger and
matters completed in connection therewith:
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On January 28, 2004, pursuant to an investment round
completed simultaneously with the signing of the definitive
Merger agreement, DeliaTroph raised equity capital of
approximately $8.1 million. |
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The stockholders of Global amended and restated Globals
Articles of Incorporation to change Globals corporate name
to Halozyme Therapeutics, Inc., increased the authorized number
of shares of common stock to 100 million, and authorized
20 million shares of preferred stock. |
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Global, now named Halozyme Therapeutics, Inc., issued
35,521,906 shares of its restricted common stock, 6,380,397
options and 11,742,665 warrants to purchase shares of its common
stock to the |
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shareholders of DeliaTroph in exchange for 100% of their issued
and outstanding common stock, options and warrants to purchase
DeliaTrophs common stock. |
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A total of 4,296,362 shares of Global, now named Halozyme
Therapeutics, Inc., outstanding common stock were redeemed by
Global from three stockholders in exchange for $42,303, or
approximately $0.01 per share. |
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Upon completion of the Merger, the pre-Merger stockholders of
Global owned approximately 10% of the issued and outstanding
shares of Halozyme Therapeutics, Inc., based on
39,421,906 shares outstanding after the Merger. |
The full text of the definitive Merger agreement may be found in
Exhibit A to our definitive Schedule 14C Information
Statement, as filed with the Securities and Exchange Commission
on February 17, 2004. The Merger has been treated as a
re-capitalization of DeliaTroph and, accordingly, our financial
statements reflect the historical activity of DeliaTroph with
the capital structure of Global, furthermore, the historical
information presented in this Annual Report reflects the
pre-merger activities of DeliaTroph and does not include
information relating to the activities of Global prior to the
Merger unless otherwise indicated. Prior to the Merger, Global
had limited operations.
In addition, on October 13, 2004, we announced the closing
of a private placement in which we sold an aggregate of
7,925,715 shares of our common stock and warrants to
purchase an additional 2,609,542 shares of our common stock
for aggregate gross proceeds of approximately $13.9 million.
Our offices and research facilities are located at 11588
Sorrento Valley Road, Suite 17, San Diego, California
92121. Our telephone number is (858) 794-8889 and our
e-mail address is info@halozyme.com. Additional
information about Halozyme can be found on our website, at
www.halozyme.com, and in our periodic and current reports
filed with the Securities and Exchange Commission
(SEC). Copies of our current and periodic reports
filed with the SEC are available at the SEC Public Reference
Room at 450 Fifth Street, N.W., Washington, D.C.
20549, and online at www.sec.gov and our website at
www.halozyme.com.
Technology
Our technology is based on recombinant human PH20 (rHuPH20), a
human synthetic version of hyaluronidase that degrades
hyaluronic acid, a space-filling gel-like substance
that is a major component of tissues throughout the body, such
as skin and cartilage. The PH20 enzyme is a naturally occurring
enzyme that digests hyaluronic acid to temporarily break down
the gel, thereby facilitating the penetration and diffusion of
other drugs that are injected in the skin or in the muscle.
Bovine and ovine-derived hyaluronidases have been used in
multiple therapeutic areas, including in vitro
fertilization and ophthalmology, where a FDA-approved bovine
version was used as a drug delivery agent to enhance dispersion
of local anesthesia for cataract surgery for over 50 years.
Despite the multiple potential therapeutic applications for
hyaluronidase, there are problems with existing and potential
animal-derived product offerings, including:
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Impurity: Most such commercial enzyme preparations are
crude extracts from cattle testes and are typically less than
1-5% pure. |
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Prion disease: Cattle testes are an organ with the
highest concentration of hyaluronidase, but also with the
highest levels of a protein implicated in the development of
neurodegenerative disorders associated with prion disease, such
as Mad Cow Disease. |
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Immunogenicity: Hyaluronidases can also be found in
bacteria, leeches, certain venoms, and marine organisms. We
believe that very few companies are pursuing clinical
development of any of these enzymes. Regardless, all such
preparations are non-human, and may elicit potent immune
reactions, possess endotoxin, or have some of the same defects
as slaughterhouse derivations. |
There have been successes in replacing animal-derived drugs with
human recombinant biologics, as in the case of insulin,
Pulmozyme and human growth hormone. Our objective is to execute
this recombinant human
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enzyme replacement strategy by applying our products under
development to key markets in multiple therapeutic areas,
beginning with in vitro fertilization (IVF) and
ophthalmology.
As an alternative to the existing animal-derived drugs, our
proprietary technology, as evidenced by our exclusive license
with the University of Connecticut of the patent covering the
DNA sequence which encodes human hyaluronidase, may both expand
existing markets and create new ones. Gaps in existing
hyaluronidase offerings may create demand for our solution, and
provide opportunities to capture market share.
Strategy
We are pursuing a recombinant human enzyme replacement strategy
to replace animal-derived hyaluronidase enzymes currently on the
market. Our objective is to develop and commercialize our first
enzyme, recombinant human hyaluronidase (rHuPH20), as a medical
device, drug enhancement agent, and therapeutic biologic. Key
aspects of our corporate strategy include the following:
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Obtain United States Food and Drug Administration
(FDA) regulatory approval of our developmental product,
Cumulasetm,
as a medical device; |
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If approved, commercialize Cumulase through our distributors; |
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File a NDA for our developmental product, Enhanze
SCtm; |
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File an IND for our developmental product,
Chemophasetm. |
Product Development Programs
We have six product candidates targeting multiple indications in
various stages of development. The following table summarizes
our lead clinical product and pipeline candidates:
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Product |
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Indication |
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Development Status | |
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Cumulase
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In vitro fertilization |
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510(k) filed |
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Enhanze SC
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Spreading factor for anesthesia |
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Pre-NDA |
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Chemophase
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Chemoadjuvant for solid tumors |
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Pre-clinical |
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HTI-101
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Inflammation, lysosomal storage disorders |
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Discovery |
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HTI-201
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Inflammation, oncology |
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Discovery |
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HTI-401
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Central nervous system trauma and disorders, wound healing |
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Discovery |
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Cumulase is an ex vivo (used outside of the body) formulation of
rHuPH20 to replace the bovine enzyme currently used for the
preparation of oocytes (eggs) prior to IVF during the
process of intracytoplasmic sperm injection (ICSI), in
which the enzyme is an essential component. The enzyme strips
away the hyaluronic acid that surrounds the oocyte. This allows
the clinician to then perform the ICSI procedure, injecting the
sperm into the oocyte. The FDA considers hyaluronidase IVF
products to be medical devices subject to 510(k) approval and we
filed our 510(k) application during September, 2004. We received
a CE (European Conformity) Mark for Cumulase in December of
2004, which allows the Company to market Cumulase in the
European Union. The total ICSI market consists of an estimated
500,000 intracytoplasmic sperm injection cycles worldwide in
2005 (Source: CDC, 2001; ESHRE, 2002).
Enhanze SC is a local formulation of rHuPH20 to replace
Wydase®, Wyeths discontinued bovine enzyme previously
used for over 50 years as a drug delivery agent to enhance
dispersion of local anesthesia for ophthalmic surgery,
particularly in cataract surgery. Its value as a spreading agent
for local anesthesia in cataract surgery is the result of its
ability to break down hyaluronic acid. When injected into the
skin or in the muscle, hyaluronidase can digest the hyaluronic
acid gel, allowing for temporarily enhanced penetration and
dispersion of other injected drugs or fluids. We plan to submit
a New Drug Application (NDA) in the first
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quarter of 2005. The market consists of approximately
6.4 million local anesthesia procedures (or 45% of the
14.2 million total estimated cataract surgery procedures)
worldwide in 2004 (Source: Medtech Insight, 2002; Marketscope,
2001; Review of Ophthalmology, 2003).
Enhanze SC is the first product in the companys broader
technology platform called
Enhanzetm
Technology, a proprietary drug enhancement system. When
co-formulated with other injectable drugs, Enhanze Technology
may facilitate the penetration and dispersion of these drugs by
temporarily opening flow channels under the skin. Molecules as
large as 200 nanometers may pass freely through the perforated
extracellular matrix which recovers its normal density within
24 hours, leading to a drug delivery platform which does
not permanently alter the architecture of the skin. Halozyme
intends to seek partnerships with pharmaceutical companies that
market drugs requiring injection via the subcutaneous or
intramuscular routes that could benefit from this technology.
Local anesthesia and other small molecule drugs: A
natural extension of Enhanze SC would be applying this
technology, used as a spreading factor for local anesthetics
around the eye, to other areas of the body. For example,
lidocaine and bupivacaine are administered for most minor
surgical operations requiring local anesthesia.
Subcutaneous Fluid Replacement (SFR): Our Enhanze SC may
also facilitate a procedure known as hypodermoclysis, which
allows subcutaneous delivery of fluids up to one liter without
the need for intravenous access. Importantly, fluid replacement
in terminal patients may be achieved without the need for
nursing assistance. This method of fluid replacement was an
approved indication of Wydase, the product that Enhanze SC is
designed to replace. Over 1.1 million SFR infusions are
performed per year with hospice patients alone (Source: Company
estimates based on National Hospice and Palliative Care
Organization data, 2001). However, over 500 million
infusion bags are utilized annually in the United States alone,
many of which could potentially convert to SFR using Enhanze SC,
giving rise to additional market potential (Source: B. Braun,
2003).
Chemophase, our third product candidate, is a chemoadjuvant
designed to enhance the transport of chemotherapeutic agents to
tumor tissue, increasing diffusion in distal tissues without
affecting vascular permeability. Chemophase is intended for
potential use in the treatment of patients with various solid
tumor malignancies. Many solid tumor types (e.g., colon, breast,
prostate) accumulate hyaluronic acid, creating a barrier to the
effective diffusion of current or future chemotherapeutics.
Previous clinical trials of bovine (bull) PH20 in patients
showed promise in enhancing chemotherapy regimens using
adjunctive systemic hyaluronidase in previously chemo-refractory
patients.
Furthermore, we have observed significant reduction of tumor
interstitial fluid pressure following the administration of
rHuPH20 in solid tumors grown in mice. Tumor interstitial
pressure is widely believed to be an important factor limiting
the access of cytostatic regimens to solid tumors. By digesting
the hyaluronic acid gel, Chemophase may reduce interstitial
pressure in the tumor and promote more effective delivery of
chemotherapy throughout the tumor, as it does under the skin, in
the case of Enhanze SC. This could potentially lead to increased
patient survival and extend the product lifecycles of many
commonly used chemotherapeutic agents.
As we continue development of an intravenous formulation of
rHuPH20, we hope to realize significant time and cost savings by
leveraging our current manufacturing process and toxicology
package to support a clinical program for a local oncology
application. We are refining the clinical targets for Chemophase
and plan to file an investigational new drug
(IND) application with the FDA in oncology during the
second quarter of 2005.
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Our HTI-101 discovery program is focused on the development of
new clinical applications for our second patented enzyme. We
intend to leverage our knowledge of this family of enzymes to
develop new indications for HTI-101 in the fields of
inflammation and lysosomal storage diseases.
We have a patented discovery program surrounding another enzyme
for use in inflammation and oncology. We intend to leverage our
recombinant protein expression capacity to develop this
technology.
HTI-401 is a fourth patented enzyme in our portfolio that has
unique substrate specificity. We intend to develop manufacturing
systems for HTI-401 to explore its use in central nervous system
trauma and wound healing.
Collaborations
We have collaborations underway using our recombinant
hyaluronidase technology for gene therapy delivery and for solid
tumor chemosensitization. Our research collaboration with the
Schering-Plough Research Institute involves the testing of
rHuPH20 hyaluronidase for enhanced gene therapy delivery. The
research collaboration with the Ludwig Boltzmann Institute of
Clinical Oncology in Vienna, Austria is exploring the effects of
rHuPH20 on the sensitivity of tumor cells to chemotherapeutic
agents. These programs are collaborative research programs
supplying recombinant enzyme with partners that have expertise
in relevant pre-clinical models or have drugs that may benefit
from our Enhanze Technology programs.
Sales and Marketing
Our sales and marketing strategy in the IVF market will consist
of a multi-channel approach that targets patients, clinicians,
suppliers, and regulators. We will raise public awareness of the
current risk of using animal-derived products in IVF
applications among industry professionals and the general public
through direct contact with target audiences, advertising in
trade journals, presentations and booths at conferences and
trade shows, mass mailings, Web initiatives, and brand-building
efforts such as press releases and other public relations
efforts. Direct contact could include communicating with key
advocacy groups, meeting with FDA officials, and attending
specialty conferences.
One of the highest impact target audiences will be the Society
for Assisted Reproductive Technology (SART), which is the
leading organization of professionals dedicated to the practice
of assisted reproductive technologies in the United States. The
organization includes over 370 members, which represents over
95% of the ART clinics in the nation. We plan on using efficacy
and safety data to recruit key thought leaders and practitioners
from this organization to help promote the use of Cumulase over
existing preparations.
There are approximately eight known suppliers of IVF reagents
and media, including micromanipulation media that contain
hyaluronidase preparations. All of these suppliers sell
animal-derived enzymes, and would benefit greatly from having
the opportunity to supply clinics with a human recombinant
hyaluronidase. We are seeking to establish non-exclusive
distribution agreements with a subset of these suppliers to
serve the worldwide marketplace. We have signed three such
worldwide distribution agreements with key suppliers serving
this market. The agreements are with MediCult AS, a
Denmark-based distributor with strengths in the European market,
MidAtlantic Diagnostics, Inc., a New Jersey-based distributor
with strengths in the North American market, and Cook Ob/ Gyn
Incorporated, an Indiana-based distributor with strengths in the
worldwide market. These three agreements are non-exclusive
distribution agreements, having five year terms with renewal
options for an additional two or three years, and granting each
of our distributors the right to purchase Cumulase from us and
resell it to end users.
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During August 2004, we signed an exclusive sales and marketing
agreement with Baxter Healthcare Corporation
(Baxter) to market, distribute and sell Enhanze SC
in the United States and Puerto Rico. Baxter and Halozyme are
equal partners in the commercialization of Enhanze SC and may
mutually agree to pursue other territories and dosage forms and
indications.
Competition
A strong clinical selling point for Cumulase is that it may
eliminate the risk of animal pathogen transmission and toxicity
inherent in slaughterhouse preparations. The competing enzymes
are of animal origin, creating an opportunity for Halozyme to
enter the market with a recombinant human enzyme alternative.
The leading IVF suppliers are CooperSurgical, Irvine Scientific,
and Cook Ob/ Gyn (bovine products) in the US, and MediCult
(ovine) and Vitrolife (bovine) outside the US.
Some commercial pharmacies now compound hyaluronidase
preparations for institutions and physicians. However, there are
several concerns with using a compounded sterile product.
Compounded preparations are not FDA-approved products. Some
compounding pharmacies do not test every batch of product for
drug concentration, sterility, and lack of pyrogens. The
American Academy of Ophthalmology therefore recommends that
compounded ophthalmic products be used within 30 days of
preparation to minimize bacterial overgrowth and drug
decomposition. Other manufacturers have FDA approved products
for use as spreading agents, including ISTA Pharmaceuticals,
Inc. (ISTA), with an ovine-derived hyaluronidase
(Vitrase®) and Amphastar Pharmaceuticals, Inc., with a
bovine (bull) hyaluronidase,
Amphadasetm.
The FDA determined that each of these products were new chemical
entities and hence afforded market exclusivity, precluding
identical products from being marketed for a period of five
years. On March 3, 2005, the FDA confirmed to us that
Enhanze SC would be designated a new chemical entity. Therefore,
we believe that it is unlikely that the Vitrase or Amphadase
marketing exclusivity will apply to Enhanze SC; but if the FDA
later changes its determination and decides that either or both
apply to Enhanze SC, then such a decision could have a material
adverse impact on our operations.
Patents and Proprietary Rights
Our success will depend in part on our ability to obtain patent
protection for our inventions, to preserve our trade secrets and
to operate without infringing the proprietary rights of third
parties. Our strategy is to actively pursue patent protection in
the United States and certain foreign jurisdictions for
technology that we believe to be proprietary and that offers a
potential competitive advantage for our inventions. Our patent
portfolio includes four issued patents and a number of pending
patent applications. We believe our patent position surrounding
recombinant human hyaluronidases and their methods of
manufacture presents a barrier to entry for potential
competitors looking to utilize these hyaluronidases.
In addition to patents, we rely on trade secrets and proprietary
know-how. We seek protection of these trade secrets and
proprietary know-how, in part, through confidentiality and
proprietary information agreements. Our policy is to require our
employees, directors, consultants and advisors, outside
scientific collaborators and sponsored researchers, other
advisors and other individuals and entities to execute
confidentiality agreements upon the start of employment,
consulting or other contractual relationships with us. These
agreements provide that all confidential information developed
or made known to the individual or entity during the course of
the relationship is to be kept confidential and not disclosed to
third parties except in specific circumstances. In the case of
employees and some other parties, the agreements provide that
all inventions conceived by the individual will be our exclusive
property. Despite the use of these agreements and our efforts to
protect our intellectual property, there will always be a risk
for unauthorized use or disclosure of information. Furthermore,
our trade secrets may otherwise become known to, or be
independently developed by, our competitors.
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We also file trademark applications to protect the names of our
products. These applications may not mature to registration and
may be challenged by third parties. We are pursuing trademark
protection in a number of different countries around the world.
Development and Manufacturing
We have signed a commercial supply agreement with Avid
Bioservices, Inc. (Avid), a contract manufacturing
organization, to produce bulk recombinant enzyme product for
clinical use. Avid will manufacture the active pharmaceutical
ingredient under commercial good manufacturing practices for
commercial scale production and will provide support for
chemistry, manufacturing and controls sections for FDA
regulatory filings. We have not established and may not be able
to establish arrangements with additional manufacturers for
these ingredients or products should the existing supplies
become unavailable or in the event that Avid is unable to
adequately perform its responsibilities. Difficulties in our
relationship with Avid or delays or interruptions in Avids
supply of its requirements could limit or stop its ability to
provide sufficient quantities of our products, on a timely
basis, for clinical trials and, if our products are approved,
could limit or stop commercial sales, which would have a
material adverse effect on our business and financial condition.
In the event that any of our product candidates are used in
clinical trials or receive the necessary regulatory approval for
commercialization, we rely on third parties to prepare, package
and fill/finish the products prior to their distribution. If we
are unable to locate third parties to perform these functions on
terms that are economically acceptable to us, the progress of
clinical trials could be delayed or even suspended and the
commercialization of approved product candidates could be
delayed or prevented. We currently utilize a third party to
fill/finish and package Cumulase. We also utilize another third
party to fill/finish and package Enhanze SC under an agreement
that is terminable by either party, but we are currently
negotiating with this third party on a long-term agreement. If
we fail to finalize an agreement with this third party, the
clinical trial progress, and potential commercialization of
Enhanze SC, will likely be delayed.
Research and Development Activities
Our research and development expenses consist primarily of costs
associated with the development and manufacturing of our product
candidates, compensation and other expenses for research and
development personnel, supplies and materials, costs for
consultants and related contract research, facility costs,
amortization and depreciation. We charge all research and
development expenses to operations as they are incurred. Our
research and development activities are primarily focused on the
development of our Cumulase and Enhanze SC product candidates,
but we are also developing Chemophase, and are currently
conducting pre-clinical studies in animal models. Our industry
is subject to rapid technological advancements, developing
industry standards and new product introductions and
enhancements. As a result, our success depends, in large part,
on our ability to develop and commercialize products.
Our research and development expenditures in fiscal 2004 and
2003 totaled approximately $6.5 million and
$1.1 million, respectively. Research and development
expenditures in fiscal 2004 and 2003 were primarily related to
the development of our Cumulase and Enhanze SC product
candidates, and, to a lesser extent, Chemophase. We anticipate
that we will have significant research and development expenses
in the future in connection with the commercialization of our
current products and development of new products.
Human Resources
As of February 15, 2005, we had 24 full-time
employees, including 17 engaged in research and clinical
development activities. Seven employees hold Ph.D. or M.D.
degrees. We anticipate hiring five to ten additional employees
by the end of 2005. We believe our relationship with our
employees is good.
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Risks Related To Our Business
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We have not generated any revenue from product sales to
date; we have a history of net losses and negative cash flow,
and may never achieve or maintain profitability. |
We have not generated any revenue from product sales to date and
may never generate significant revenues from future product
sales. Even if we do achieve significant revenues from product
sales, we expect to incur significant operating losses over the
next several years. We have never been profitable, and may never
become profitable. Through December 31, 2004, we have
incurred aggregate net losses of $13,071,881.
We may need to raise funds in the next twelve months, and
there can be no assurance that such funds will be
available.
During the next twelve months we may need to raise additional
capital to complete the steps required to obtain FDA or other
regulatory approval for any of our products. If we engage in
acquisitions of companies, products, or technology in order to
execute our business strategy, we may need to raise additional
capital. We may be required to raise additional capital in the
future through the public offering of securities, collaborative
agreements, private financings and various other equity or debt
financings, including calling outstanding warrants to purchase
our common stock. Currently, warrants to purchase approximately
11.8 million shares of our common stock are outstanding and
this amount of outstanding warrants may make us a less desirable
candidate for investment for some potential investors.
Approximately 5.9 million of our outstanding warrants
contain a call feature that, potentially, will allow us to raise
funds from the holders of these warrants. If our common stock
closes at a price equal to or greater than $2.00 per share
for twenty consecutive trading days, we have the ability, at our
sole discretion, to call warrants exercisable for up to
approximately 1,971,000 shares of common stock, provided
that we have not exercised a call right in the preceding three
months. Upon such a call, the holders of these warrants have
thirty days to decide whether to either exercise their warrants
at a price of $1.75 per share or receive $0.01 from us for
each share of common stock that is not exercised. If we need to
raise funds in the future and we wish to utilize this call
right, we will not be able to exercise the call right if we do
not meet the minimum closing price condition and, even if we
meet this condition, we cannot be sure of the amounts that will
be raised by such a call because some or all warrant holders may
decide not to exercise their warrants. Considering our stage of
development and the nature of our capital structure, if we are
required to raise additional capital in the future, the
additional financing may not be available on favorable terms, or
at all. If we are successful in raising additional capital, a
substantial number of additional shares will be outstanding and
would dilute the ownership interest of our investors.
If we do not receive and maintain regulatory approvals for
our product candidates, we will not be able to commercialize our
products, which would substantially impair our ability to
generate revenues.
With the exception of the December 2004 receipt of a CE
(European Conformity) Mark for Cumulase, none of our product
candidates have received regulatory approval from the FDA or
from any similar national regulatory agency or authority in any
other country in which we intend to do business. Approval from
the FDA is necessary to manufacture and market pharmaceutical
products in the United States. Many other countries including
major European countries and Japan have similar requirements.
During September, 2004, we filed a 510(k) application for
Cumulase and we intend to file a NDA for Enhanze SC in the first
quarter of 2005. Other manufacturers have FDA approved products
for use as spreading agents, including ISTA Pharmaceuticals,
Inc. (ISTA), with an ovine-derived hyaluronidase
(Vitrase®) and Amphastar Pharmaceuticals, Inc., with a
bovine (bull) hyaluronidase,
Amphadasetm.
The FDA determined that each of these products were new chemical
entities and hence afforded market exclusivity, precluding
identical products from being marketed for a period of five
years. On March 3, 2005, the FDA confirmed to us that
Enhanze SC would be designated a new chemical entity. Therefore,
we believe that it is unlikely that the Vitrase or Amphadase
marketing exclusivity will apply to Enhanze SC; but if the FDA
later changes its determination and decides that either or both
apply to Enhanze SC, then such a decision could have a material
adverse impact on our operations.
8
The processes for obtaining FDA approval are extensive,
time-consuming and costly, and there is no guarantee that the
FDA will approve our recently filed 510(k) application or any
NDAs that we intend to file with respect to any of our product
candidates, or that the timing of any such approval will be
appropriate for our product launch schedule and other business
priorities, which are subject to change. We have not currently
begun the NDA approval process for any of our potential
products, and we may not be successful in obtaining such
approvals for any of our potential products.
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If we are unsuccessful in our clinical trials, we will not
receive regulatory approvals for our product candidates. |
Clinical testing of pharmaceutical products is also a long,
expensive and uncertain process. Even if initial results of
pre-clinical studies or clinical trial results are positive, we
may obtain different results in later stages of drug
development, including failure to show desired safety and
efficacy.
The clinical trials of any of our product candidates could be
unsuccessful, which would prevent us from obtaining regulatory
approval and commercializing the product. FDA approval can be
delayed, limited or not granted for many reasons, including,
among others:
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FDA officials may not find a product candidate safe or effective
to merit an approval; |
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FDA officials may not find that the data from pre-clinical
testing and clinical trials justify approval, or they may
require additional studies that would make it commercially
unattractive to continue pursuit of approval; |
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the FDA may not approve our manufacturing processes or
facilities, or the processes or facilities of our contract
manufacturers or raw material suppliers; |
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the FDA may change its approval policies or adopt new
regulations; and |
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the FDA may approve a product candidate for indications that are
narrow or under conditions that place the product at a
competitive disadvantage, which may limit our sales and
marketing activities or otherwise adversely impact the
commercial potential of a product. |
If the FDA does not approve our product candidates in a timely
fashion on commercially viable terms or we terminate development
of any of our product candidates due to difficulties or delays
encountered in the regulatory approval process, it will have a
material adverse impact on our business and we will be dependent
on the development of our other product candidates and/or our
ability to successfully acquire other products and technologies.
In addition, we intend to market certain of our products, and
perhaps have certain of our products manufactured, in foreign
countries. The process of obtaining approvals in foreign
countries is subject to delay and failure for similar reasons.
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If our product candidates are approved by the FDA but do
not gain market acceptance, our business will suffer because we
may not be able to fund future operations. |
Assuming that we obtain the necessary regulatory approvals, a
number of factors may affect the market acceptance of any of our
existing product candidates or any other products we develop or
acquire in the future, including, among others:
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the price of our products relative to other therapies for the
same or similar treatments; |
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the perception by patients, physicians and other members of the
health care community of the effectiveness and safety of our
products for their prescribed treatments; |
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our ability to fund our sales and marketing efforts; |
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the effectiveness of our sales and marketing efforts; and |
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the introduction of generic competitors. |
9
We have never successfully marketed any products, and we may not
be successful in marketing and promoting our existing product
candidates or any other products we develop or acquire in the
future.
In addition, our ability to market and promote our product
candidates will be restricted to the labels approved by the FDA.
If the approved labels are restrictive, our sales and marketing
efforts, as well as market acceptance and the commercial
potential of our products may be negatively affected.
If our products do not gain market acceptance, we may not be
able to fund future operations, including the development or
acquisition of new product candidates and/or our sales and
marketing efforts for our approved products, which would cause
our business to suffer.
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If we are unable to sufficiently develop our sales,
marketing and distribution capabilities or enter into agreements
with third parties to perform these functions, we will not be
able to commercialize products. |
We are currently in the process of developing our sales,
marketing and distribution capabilities. However, our current
capabilities in these areas are very limited. In order to
commercialize any products successfully, we must internally
develop substantial sales, marketing and distribution
capabilities, or establish collaborations or other arrangements
with third parties to perform these services. We do not have
extensive experience in these areas, and we may not be able to
establish adequate in-house sales, marketing and distribution
capabilities or engage and effectively manage relationships with
third parties to perform any or all of such services. To the
extent that we enter into co-promotion or other licensing
arrangements, our product revenues are likely to be lower than
if we directly marketed and sold our products, and any revenues
we receive will depend upon the efforts of third parties, whose
efforts may not be successful.
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If we have problems with our sole contract manufacturer,
our product development and commercialization efforts for our
product candidates could be delayed or stopped. |
We have signed a commercial supply agreement with Avid
Bioservices Incorporated (Avid), a contract
manufacturing organization, to produce bulk recombinant human
hyaluronidase for clinical use. Avid will produce the active
pharmaceutical ingredient under current good manufacturing
practices for commercial scale production and will provide
support for chemistry, manufacturing and controls sections for
FDA regulatory filings. The active pharmaceutical ingredient is
used in Enhanze SC, which may require a pre-approval inspection.
If Avid fails this pre-approval inspection, it could have a
material adverse effect on our business. We have not established
and may not be able to establish arrangements with additional
manufacturers for these ingredients or products should the
existing supplies become unavailable or in the event that our
sole contract manufacturer is unable to adequately perform its
responsibilities. Difficulties in our relationship with Avid or
delays or interruptions in Avids supply of its
requirements could limit or stop our ability to provide
sufficient quantities of our products, on a timely basis, for
clinical trials and, if our products are approved, could limit
or stop commercial sales, which would have a material adverse
effect on our business and financial condition.
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If we have problems with the third parties that prepare,
package and fill/ finish our product candidates for
distribution, our product development and commercialization
efforts for these candidates could be delayed or stopped. |
In the event that any of our product candidates are used in
clinical trials or receive the necessary regulatory approval for
commercialization, we rely on third parties to prepare, package
and fill/finish the products prior to their distribution. If we
are unable to locate third parties to perform these functions on
terms that are economically acceptable to us, the progress of
clinical trials could be delayed or even suspended and the
commercialization of approved product candidates could be
delayed or prevented. We currently utilize a third party to
fill/finish and package Cumulase. In addition, we currently
utilize a third party to fill/finish and package Enhanze SC
under an agreement that is terminable by either party, but we
are currently negotiating with this third party on a long-term
agreement. If we fail to finalize an agreement with this third
party, the clinical trial progress, and potential
commercialization of Enhanze SC, will likely be delayed.
10
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Our inability to attract, hire and retain key management
and scientific personnel, and to recruit qualified independent
directors, could negatively affect our business. |
Our success depends on the performance of key management and
scientific employees with biotechnology experience. Given our
small staff size and programs currently under development, we
depend substantially on our ability to hire, train, retain and
motivate high quality personnel, especially our scientists and
management team in this field. In addition, we also rely on the
expertise and guidance of independent directors to develop
business strategies and to guide our execution of these
strategies. Due to changes in the regulatory environment for
public companies over the past few years, the demand for
independent directors has increased and it may be difficult for
us, due to competition from both like-sized and larger
companies, to recruit qualified independent directors.
Furthermore, if we were to lose key management personnel,
particularly Jonathan Lim, MD, our chief executive officer, or
Gregory Frost, PhD, our chief scientific officer, then we would
likely lose some portion of our institutional knowledge and
technical know-how, potentially causing a substantial delay in
one or more of our development programs until adequate
replacement personnel could be hired and trained. For example,
Dr. Frost has been with our Company from soon after its
inception, and he possesses a substantial amount of knowledge
about our development efforts. If we were to lose his services,
we would experience delays in meeting our product development
schedules. We have not entered into employment agreements with
any of our employees or officers, including Dr. Lim and
Dr. Frost. We do not have key man life insurance policies
on the lives of any of our employees, including Dr. Lim and
Dr. Frost.
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Future sales of shares of our common stock, including
sales of shares issued in our most recent financings, may
negatively affect our stock price. |
As a result of our January 2004 private financing transaction,
we issued 19,046,721 shares of common stock to certain
private investors. In connection with this transaction we also
issued warrants to the private investors for the purchase of
10,461,943 shares of common stock at purchase prices
ranging from $0.77 to $1.75 per share. Currently,
8.3 million shares of common stock remain issuable upon
exercise of these warrants. The exercise of these warrants could
result in significant dilution to stockholders at the time of
exercise. We filed a registration statement on Form SB-2
(Registration No. 333-114776), which was declared effective
on August 12, 2004, covering the 29,508,664 shares
issued to the private investors and issuable upon exercise of
the warrants.
As a result of our October 2004 financing transaction, we issued
7,925,715 shares of common stock to certain institutional
and accredited investors for $13.9 million in gross
proceeds. In connection with this transaction, we also issued
warrants for the purchase of 2,609,542 shares of common
stock. We filed a registration statement on Form S-3
(Registration No. 333-120448), which was declared effective
on November 26, 2004, covering the 10,535,257 shares
issued to the private investors and issuable upon exercise of
the warrants. In the future, we may issue additional options,
warrants or other derivative securities convertible into
Halozyme common stock.
Sales of substantial amounts of shares of our common stock, or
even the potential for such sales through the exercise of
warrants, could lower the market price of our common stock and
impair the Companys ability to raise capital through the
sale of equity securities.
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Our stock price is subject to significant
volatility. |
Our stock price is subject to significant volatility. Overall
market conditions, in addition to other risks and uncertainties
described in this section and elsewhere in this report, may
cause the market price of our common stock to fall. We
participate in a highly dynamic industry, which often results in
significant volatility in the market price of common stock
irrespective of company performance. As a result, our high and
low stock prices during 2004 were $4.75 and $0.02, respectively.
Fluctuations in the price of our common stock may be exacerbated
by conditions in the healthcare and technology industry segments
or conditions in the financial markets generally.
11
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Recent trading in our stock has been limited, so investors
may not be able to sell as much stock as they want to at
prevailing market prices. |
During the last ninety days, our average daily trading volume
was approximately 164,000 shares. If limited trading in our
stock continues, it may be difficult for stockholders to sell
their shares in the public market at any given time at
prevailing prices.
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Our decision to redeem outstanding warrants may drive down
the market price of our stock. |
As discussed above in the Risk Related to Our Business titled
We may need to raise funds in the next twelve months,
and there can be no assurance that such funds will be
available we may have the ability to redeem certain
outstanding warrants, under certain conditions, that may be
exercised for approximately 5.9 million shares of common
stock. The redemption price for these warrants is $0.01 per
share, but the warrant holders have the opportunity to exercise
their warrants prior to redemption at the price of
$1.75 per share. If we decide to redeem any portion of our
outstanding warrants in the future, some selling security
holders may choose to sell outstanding shares of common stock in
order to finance the exercise of the warrants prior to their
redemption. This pattern of selling may result in a reduction of
our common stocks market price.
Risks Related To Our Industry
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Compliance with the extensive government regulations to
which we are subject is expensive and time consuming, and may
result in the delay or cancellation of product sales,
introductions or modifications. |
Extensive industry regulation has had, and will continue to
have, a significant impact on our business. All pharmaceutical
companies, including Halozyme, are subject to extensive,
complex, costly and evolving regulation by the federal
government, principally the FDA and to a lesser extent by the
U.S. Drug Enforcement Administration (DEA), and
foreign and state government agencies. The Federal Food, Drug
and Cosmetic Act, the Controlled Substances Act and other
domestic and foreign statutes and regulations govern or
influence the testing, manufacturing, packing, labeling,
storing, record keeping, safety, approval, advertising,
promotion, sale and distribution of our products. Under certain
of these regulations, Halozyme and its contract suppliers and
manufacturers are subject to periodic inspection of its or their
respective facilities, procedures and operations and/or the
testing of products by the FDA, the DEA and other authorities,
which conduct periodic inspections to confirm that Halozyme and
its contract suppliers and manufacturers are in compliance with
all applicable regulations. The FDA also conducts pre-approval
and post-approval reviews and plant inspections to determine
whether our systems, or our contract suppliers and
manufacturers processes, are in compliance with current
good manufacturing practices and other FDA regulations. If we,
or our contract supplier, fail these inspections, we may not be
able to commercialize our product in a timely manner without
incurring significant additional costs, or at all.
In addition, the FDA imposes a number of complex regulatory
requirements on entities that advertise and promote
pharmaceuticals, including, but not limited to, standards and
regulations for direct-to-consumer advertising, off-label
promotion, industry-sponsored scientific and educational
activities, and promotional activities involving the Internet.
We are dependent on receiving FDA and other governmental
approvals prior to manufacturing, marketing and shipping our
products. Consequently, there is always a risk that the FDA or
other applicable governmental authorities will not approve our
products, or will take post-approval action limiting or revoking
our ability to sell our products, or that the rate, timing and
cost of such approvals will adversely affect our product
introduction plans or results of operations.
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Our suppliers and sole manufacturer are subject to
regulation by the FDA and other agencies, and if they do not
meet their commitments, we would have to find substitute
suppliers or manufacturers, which could delay the supply of our
products to market. |
Regulatory requirements applicable to pharmaceutical products
make the substitution of suppliers and manufacturers costly and
time consuming. We have no internal manufacturing capabilities
and are, and expect
12
to be in the future, entirely dependent on contract
manufacturers and suppliers for the manufacture of our products
and for their active and other ingredients. The disqualification
of these manufacturers and suppliers through their failure to
comply with regulatory requirements could negatively impact our
business because the delays and costs in obtaining and
qualifying alternate suppliers (if such alternative suppliers
are available, which we cannot assure) could delay clinical
trials or otherwise inhibit our ability to bring approved
products to market, which would have a material adverse affect
on our business and financial condition.
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We may be required to initiate or defend against legal
proceedings related to intellectual property rights, which may
result in substantial expense, delay and/or cessation of the
development and commercialization of our products. |
We rely on patents to protect our intellectual property rights.
The strength of this protection, however, is uncertain. For
example, it is not certain that:
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our patents and pending patent applications cover products
and/or technology that we invented first; |
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we were the first to file patent applications for these
inventions; |
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others will not independently develop similar or alternative
technologies or duplicate our technologies; |
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any of our pending patent applications will result in issued
patents; and |
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any of our issued patents, or patent pending applications that
result in issued patents, will be held valid and infringed in
the event the patents are asserted against others. |
We currently own or license several U.S. patents and also
have pending patent applications. There can be no assurance that
our existing patents, or any patents issued to us as a result of
such applications, will provide a basis for commercially viable
products, will provide us with any competitive advantages, or
will not face third-party challenges or be the subject of
further proceedings limiting their scope or enforceability.
We may become involved in interference proceedings in the
U.S. Patent and Trademark Office to determine the priority
of our inventions. In addition, costly litigation could be
necessary to protect our patent position. We also rely on
trademarks to protect the names of our products. These
trademarks may be challenged by others. If we enforce our
trademarks against third parties, such enforcement proceedings
may be expensive. We also rely on trade secrets, unpatented
proprietary know-how and continuing technological innovation
that we seek to protect with confidentiality agreements with
employees, consultants and others with whom we discuss our
business. Disputes may arise concerning the ownership of
intellectual property or the applicability or enforceability of
these agreements, and we might not be able to resolve these
disputes in our favor.
In addition to protecting our own intellectual property rights,
third parties may assert patent, trademark or copyright
infringement or other intellectual property claims against us
based on what they believe are their own intellectual property
rights. While we have not ever been and are currently not
involved in any litigation, in the event we become involved, we
may be required to pay substantial damages, including but not
limited to treble damages, for past infringement if it is
ultimately determined that our products infringe a third
partys intellectual property rights. Even if infringement
claims against us are without merit, defending a lawsuit takes
significant time, may be expensive and may divert
managements attention from other business concerns.
Further, we may be stopped from developing, manufacturing or
selling our products until we obtain a license from the owner of
the relevant technology or other intellectual property rights.
If such a license is available at all, it may require us to pay
substantial royalties or other fees.
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Future acquisitions could disrupt our business and harm
our financial condition. |
In order to remain competitive, we may decide to acquire
additional businesses, products and technologies. As we have
limited experience in evaluating and completing acquisitions,
our ability as an organization to
13
make such acquisitions is unproven. Acquisitions could require
significant capital infusions and could involve many risks,
including, but not limited to, the following:
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we may have to issue convertible debt or equity securities to
complete an acquisition, which would dilute our stockholders and
could adversely affect the market price of our common stock; |
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an acquisition may negatively impact our results of operations
because it may require us to incur large one-time charges to
earnings, amortize or write down amounts related to goodwill and
other intangible assets, or incur or assume substantial debt or
liabilities, or it may cause adverse tax consequences,
substantial depreciation or deferred compensation charges; |
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we may encounter difficulties in assimilating and integrating
the business, technologies, products, personnel or operations of
companies that we acquire; |
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certain acquisitions may disrupt our relationship with existing
customers who are competitive with the acquired business; |
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acquisitions may require significant capital infusions and the
acquired businesses, products or technologies may not generate
sufficient revenue to offset acquisition costs; |
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an acquisition may disrupt our ongoing business, divert
resources, increase our expenses and distract our management; |
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acquisitions may involve the entry into a geographic or business
market in which we have little or no prior experience; and |
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key personnel of an acquired company may decide not to work for
us. |
If any of these risks occurred, it could adversely affect our
business, financial condition and operating results. We cannot
assure you that we will be able to identify or consummate any
future acquisitions on acceptable terms, or at all. If we do
pursue any acquisitions, it is possible that we may not realize
the anticipated benefits from such acquisitions or that the
market will not view such acquisitions positively.
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If third-party reimbursement is not available, our
products may not be accepted in the market. |
Our ability to earn sufficient returns on our products will
depend in part on the extent to which reimbursement for our
products and related treatments will be available from
government health administration authorities, private health
insurers, managed care organizations and other healthcare
providers.
Third-party payers are increasingly attempting to limit both the
coverage and the level of reimbursement of new drug products to
contain costs. Consequently, significant uncertainty exists as
to the reimbursement status of newly approved healthcare
products. If we succeed in bringing one or more of our product
candidates to market, third-party payers may not establish
adequate levels of reimbursement for our products, which could
limit their market acceptance and result in a material adverse
effect on our financial condition.
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We face intense competition and rapid technological change
that could result in the development of products by others that
are superior to the products we are developing. |
We have numerous competitors in the United States and abroad,
including, among others, major pharmaceutical and specialized
biotechnology firms, universities and other research
institutions that may be developing competing products. Such
competitors include Sigma-Aldrich Corporation, ISTA
Pharmaceuticals, Inc. (ISTA), and Allergan, Inc., among others.
These competitors may develop technologies and products that are
more effective or less costly than our current or future product
candidates or that could render our technologies and product
candidates obsolete or noncompetitive. Many of these competitors
have substantially more resources and product development,
manufacturing and marketing experience and capabilities than we
do. In addition, many of our competitors have significantly
greater experience than we do in undertaking pre-clinical
testing and clinical trials of pharmaceutical product candidates
and obtaining FDA and other regulatory approvals of products and
therapies for use in healthcare. Other manufacturers have FDA
approved products for use as spreading agents, including ISTA
Pharmaceuticals, Inc. (ISTA), with an
14
ovine-derived hyaluronidase (Vitrase®) and Amphastar
Pharmaceuticals, Inc., with a bovine (bull) hyaluronidase,
Amphadasetm.
The FDA determined that each of these products were new chemical
entities and hence afforded market exclusivity, precluding
identical products from being marketed for a period of five
years. On March 3, 2005, the FDA confirmed to us that
Enhanze SC would be designated a new chemical entity. Therefore,
we believe that it is unlikely that the Vitrase or Amphadase
marketing exclusivity will apply to Enhanze SC; but if the FDA
later changes its determination and decides that either or both
apply to Enhanze SC, then such a decision could have a material
adverse impact on our operations.
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We are exposed to product liability claims, and insurance
against these claims may not be available to us on reasonable
terms or at all. |
We might incur substantial liability in connection with clinical
trials or the sale of our products. Product liability insurance
is expensive and in the future may not be available on
commercially acceptable terms, or at all. We currently carry a
limited amount of product liability insurance. A successful
claim or claims brought against us in excess of our insurance
coverage could materially harm our business and financial
condition.
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We may have difficulty implementing in a timely manner the
internal controls over financial reporting necessary to allow
our management to report on the effectiveness of our internal
controls over financial reporting, and we may incur substantial
costs in order to comply with the requirements of the
Sarbanes-Oxley Act of 2002. |
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002,
we will be required to furnish a report of managements
assessment of the effectiveness of our internal controls over
financial reporting as part of our Annual Report on
Form 10-KSB for the fiscal year ended December 31,
2006. Our registered public accountant will then be required to
attest to, and report on, our assessment. In order to issue our
report, our management must document both the design for our
internal controls over financial reporting and the testing
processes that support managements evaluation and
conclusion. There can be no assurance that we will be able to
complete the work necessary for our management to issue its
management report in a timely manner, or that management will be
able to report that our internal controls over financial
reporting are effective.
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Item 2. |
Description of Property. |
Our administrative offices and research facilities are located
in San Diego, California. We lease an aggregate of
approximately 10,800 square feet of office and research
space for approximately $20,000 per month. We have two
separate leases for our facilities that expire on June 30,
2005 (5,700 square feet) and June 30, 2006
(5,100 square feet), respectively. We believe the space is
adequate for our immediate needs, but additional space may be
required as we expand our research and development activities.
We do not foresee any significant difficulties in obtaining any
required additional facilities.
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Item 3. |
Legal Proceedings. |
From time to time, Halozyme may be involved in litigation
relating to claims arising out of its operations in the normal
course of business. Any of these claims could subject us to
costly litigation and, while we generally believe that we have
adequate insurance to cover many different types of liabilities,
our insurance carriers may deny coverage or our policy limits
may be inadequate to fully satisfy any damage awards or
settlements. If this were to happen, the payment of any such
awards could have a material adverse effect on our results of
operations and financial position. Additionally, any such
claims, whether or not successful, could damage our reputation
and business. Halozyme currently is not a party to any legal
proceedings, the adverse outcome of which, in managements
opinion, individually or in the aggregate, would have a material
adverse effect on our results of operations or financial
position.
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Item 4. |
Submission of Matters to a Vote of Security
Holders. |
There were no matters submitted to a vote of security holders of
Halozyme during the fourth quarter of fiscal 2004.
15
PART II
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Item 5. |
Market for Common Equity and Related Stockholder
Matters. |
Since November 1, 2004, our common stock has traded under
the symbol HTI on The American Stock Exchange (the
AMEX). From March 12, 2004 through
October 31, 2004 our common stock traded under the symbol
HZYM on the Over-the-Counter Bulletin Board.
Prior to the effectiveness of the merger between Global Yacht
Services, Inc. and our predecessor company DeliaTroph
Pharmaceuticals, Inc. on March 11, 2004, our common stock
traded under the symbol GYHT on the Over-the-Counter
Bulletin Board. The following table sets forth the high and
low sales prices per share of our common stock:
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Fiscal Year 2004 |
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High | |
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Low | |
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First Quarter
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$ |
4.75 |
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$ |
0.02 |
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Second Quarter
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$ |
4.68 |
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$ |
2.55 |
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Third Quarter
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$ |
3.35 |
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$ |
1.41 |
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Fourth Quarter
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$ |
3.10 |
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$ |
1.80 |
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Fiscal Year 2003 |
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High | |
|
Low | |
|
|
| |
|
| |
First Quarter
|
|
|
n/a |
|
|
|
n/a |
|
Second Quarter
|
|
$ |
0.12 |
|
|
$ |
0.05 |
|
Third Quarter
|
|
$ |
0.10 |
|
|
$ |
0.05 |
|
Fourth Quarter
|
|
$ |
0.10 |
|
|
$ |
0.02 |
|
On February 15, 2005, the closing sales price of Common
Stock was $2.03 per share. As of February 15, 2005, we
had approximately 610 shareholders of record. We have not
paid any dividends on our common stock since our inception and
do not expect to pay dividends on our common stock in the
foreseeable future.
|
|
Item 6. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations. |
In addition to historical information, the following
discussion contains forward-looking statements that are subject
to risks and uncertainties. Actual results may differ
substantially from those referred to herein due to a number of
factors, including but not limited to risks described in the
section entitled Risks Related to Our Business and elsewhere in
this Annual Report.
Overview DeliaTroph Pharmaceuticals, Inc.
(DeliaTroph), the predecessor company to Halozyme,
was founded on February 26, 1998. On March 11, 2004,
DeliaTroph merged with a publicly traded corporation, Global
Yacht Services, Inc. (Global), to
form Halozyme. Although Global (which changed its name to
Halozyme Therapeutics, Inc. in connection with the Merger)
acquired DeliaTroph as a result of the merger, the former
shareholders of DeliaTroph held a majority of the voting
interest in the combined enterprise immediately after the
Merger. Additionally, the Merger resulted in DeliaTrophs
management and Board of Directors assuming operational control
of Halozyme Therapeutics, Inc. Accordingly, the Merger has been
treated as a re-capitalization of DeliaTroph and the financial
information presented here and elsewhere in this Annual Report
reflects the historical activity of DeliaTroph, unless otherwise
indicated. Global conducted limited operations prior to the
merger in a line of business wholly unrelated to
biopharmaceutical operations, and the results of Globals
operations are not reflected in the financial information of
Halozyme.
We are a development stage biopharmaceutical company dedicated
to the development and planned commercialization of recombinant
human enzymes for the infertility, ophthalmology, and oncology
communities. Our products under development are based on
intellectual property covering the family of human enzymes known
as hyaluronidases. Hyaluronidases are enzymes
(proteins) that break down hyaluronic acid, which is a
naturally occurring substance in the human body. Currently, we
have no product revenue and all of our potential products are
either in the discovery, pre-clinical, pre-NDA or pre-510(k)
stage. It may be years, if ever, before we are able to obtain
the necessary regulatory approvals necessary to generate
meaningful revenue from the sale of these potential products. In
addition, we have never generated any revenue from our
16
biopharmaceutical operations and we have had operating and net
losses each year since inception. We have accumulated a deficit
of $13,071,881 from inception through December 31, 2004.
Our technology is based on recombinant human PH20 (rHuPH20), a
human synthetic version of hyaluronidase that degrades
hyaluronic acid, a space-filling, gel-like substance
that is a major component of tissues throughout the body, such
as the skin and eyes. The PH20 enzyme is a naturally occurring
enzyme that digests hyaluronic acid to temporarily break down
the gel, thereby facilitating the penetration and dispersion of
other drugs that are injected in the skin or in the muscle.
Bovine and ovine-derived hyaluronidases have been used in
multiple therapeutic areas, including in vitro
fertilization and ophthalmology, where a FDA-approved bovine
version was used as a drug delivery agent to enhance dispersion
of local anesthesia for cataract surgery for over 50 years.
Despite the multiple potential therapeutic applications for
hyaluronidase, there are problems with existing and potential
animal-derived product offerings, including:
|
|
|
|
|
Impurity: Most such commercial enzyme preparations are
crude extracts from cattle testes and are typically less than
1-5% pure. |
|
|
|
Prion disease: Cattle testes are an organ with the
highest concentration of hyaluronidase, but also with the
highest levels of a protein implicated in the development of
neurodegenerative disorders associated with prion disease, such
as Mad Cow Disease. |
|
|
|
Immunogenicity: Hyaluronidases can also be found in
bacteria, leeches, certain venoms, and marine organisms. Very
few companies are pursuing clinical development of any of these
enzymes. Regardless, all such preparations are non-human, and
are therefore likely to elicit potent immune reactions, possess
endotoxin, or have some of the same defects as slaughterhouse
derivations. |
There have been successes in replacing animal-derived drugs with
human recombinant biologics, as in the case of insulin,
Pulmozyme and human growth hormone. Our objective is to execute
this recombinant human enzyme replacement strategy by applying
our products under development to key markets in multiple
therapeutic areas, beginning with in vitro fertilization
and ophthalmology.
As an alternative to the existing animal-derived drugs, our
proprietary technology, as evidenced by our exclusive license
with the University of Connecticut of the patent covering the
DNA sequence which encodes human hyaluronidase, may both expand
existing markets and create new ones. Gaps in existing
hyaluronidase offerings may create demand for our solution.
We have not generated any revenues from product sales since our
inception on February 26, 1998. Product revenue will depend
on our ability to obtain regulatory approvals for and
successfully commercialize our product candidates. We received a
CE (European Conformity) Mark for Cumulase in December of 2004,
which allows the Company to market Cumulase in the European
Union.
Research and Development. Our research and development
expenses consist primarily of costs associated with the
development and manufacturing of our product candidates,
compensation and other expenses for research and development
personnel, supplies and materials, costs for consultants and
related contract research, facility costs, amortization and
depreciation. We charge all research and development expenses to
operations as they are incurred. Our research and development
activities are primarily focused on the development of our
Cumulase and Enhanze SC product candidates which are both based
on our recombinant human PH20 (rHuPH20) enzyme, a human
synthetic version of hyaluronidase. We are also developing
Chemophase, which is also based on our recombinant PH20 enzyme,
and are currently conducting pre-clinical studies in animal
models.
Since our inception through December 31, 2004, we have
incurred research and development costs of $8.9 million.
From January 1, 2002 through December 31, 2004,
approximately 90% of our research and
17
development costs were associated with the research and
development of our recombinant human PH20 enzyme used in our
Cumulase and Enhanze SC product candidates. Due to the
uncertainty in obtaining FDA approval, our reliance on third
parties, and competitive pressures, we are unable to estimate
with any certainty the additional costs we will incur in the
continued development of our Cumulase, Enhanze SC, and
Chemophase product candidates for commercialization. However, we
expect our research and development costs to increase
substantially if we are able to advance our product candidates
into later stages of clinical development.
Clinical development timelines, likelihood of success, and total
costs vary widely. Although we are currently focused primarily
on advancing Cumulase, Enhanze SC, and Chemophase, we anticipate
that we will make determinations as to which research and
development projects to pursue and how much funding to direct to
each project on an on-going basis in response to the scientific
and clinical progress of each product candidate and other market
developments.
Product candidate completion dates and costs vary significantly
for each product candidate and are difficult to estimate. The
lengthy process of seeking regulatory approvals, and the
subsequent compliance with applicable regulations, require the
expenditure of substantial resources. Any failure by us to
obtain, or any delay in obtaining, regulatory approvals could
cause our research and development expenditures to increase and,
in turn, have a material adverse effect on our results of
operations. While we have filed a 510(k) application for our
Cumulase product candidate in September 2004, and we anticipate
filing a NDA for our Enhanze SC product candidate in the first
quarter of 2005, and an IND for our Chemophase product candidate
in the second quarter of 2005, we cannot be certain when or if
any net cash inflow from these products or any of our other
development projects will commence.
General and Administrative. General and administrative
expenses consist primarily of compensation and other expenses
related to our corporate operations and administrative
employees, legal fees and other professional services expenses.
Other Income and Expense, Net. Other income and expense,
net consists primarily of interest income earned on our cash and
cash equivalents and interest expense associated with our
short-term notes payable. Other income and expense, net, also
includes the liabilities assumed as a result of the Merger.
Critical Accounting Policies and Estimates
The preparation of financial statements in accordance with
accounting principles generally accepted in the United States
requires that management make a number of assumptions and
estimates that affect the reported amounts of assets,
liabilities, revenues and expenses in our consolidated financial
statements and accompanying notes. Management bases its
estimates on historical information and assumptions believed to
be reasonable. Although these estimates are based on
managements best knowledge of current events and
circumstances that may impact the Company in the future, actual
results may differ from these estimates.
Our critical accounting policies are those that affect our
financial statements materially and involve a significant level
of judgment by management. While we have not yet recorded any
revenue to date, our critical accounting policy regarding
revenue recognition is to record revenue when the transfer of
ownership occurs, upon shipment to the distributor. Our critical
accounting policies also include estimating the useful lives of
fixed assets and the resulting depreciation expense and the
amount and valuation of inventory.
Results of Operations Comparison of Year Ended
December 31, 2004 and 2003
Revenues Halozyme has generated no revenues
since its inception on February 26, 1998.
Research and Development Research and
development expenses were $6,517,000 for the year ended
December 31, 2004 compared to $1,145,000 for the year ended
December 31, 2003. Our research and development expenses
consisted primarily of costs associated with the development and
manufacturing of our product candidates, compensation and other
expenses for research and development personnel, supplies and
materials, costs for consultants and related contract research,
facility costs, amortization and depreciation. Research and
development expenses increased by $5,372,000 due primarily to
completion of Cumulase 510(k) requirements, the substantial
completion of Enhanze SC chemistry manufacturing and controls
18
(CMC) and toxicology work, the hiring of additional
research and development personnel, and contract manufacturing
costs for development and production of our rHuPH20 enzyme for
research, clinical, and potential commercial use. We expect
research and development costs to continue to increase in future
periods as we increase our research efforts and continue to
develop and manufacture our first two product candidates.
General and Administrative General and
administrative expenses were $2,571,000 for the year ended
December 31, 2004 compared to $576,000 for the year ended
December 31, 2003. General and administrative expenses
increased by $1,995,000 due to the hiring of additional
administrative personnel and the increased legal and accounting
fees associated with becoming a public reporting entity. We
anticipate that compliance with provisions of the Sarbanes-Oxley
Act of 2002, including Section 404 relating to audits of
our internal controls, will increase our general and
administrative costs in future periods.
Other Income and Expense Other expense was
$4,000 for the year ended December 31, 2004 compared to
$393,000 for the year ended December 31, 2003. The decrease
in other expense was due to interest expense incurred in 2003
from outstanding notes payable, which were converted to common
stock in October 2003.
Net Loss Net loss for the year ended
December 31, 2004 was $9,091,000, or $0.26 per common
share, compared to $2,115,000, or $0.26 per common share
for the year ended December 31, 2003. The increase in net
loss was due to an increase in operating expenses, reflecting
our increased research and development efforts and additional
personnel costs.
Liquidity and Capital Resources As of
December 31, 2004, cash and cash equivalents were
$16,007,000 versus $504,000 as of December 31, 2003, an
increase of $15,503,000. This increase resulted primarily from
the sale of common stock and warrants to purchase common stock
for approximately $23,450,000, net of issuance costs during the
year ended December 31, 2004, offset by our net cash used
in operations and for the purchase of property and equipment for
the year ended December 31, 2004.
Net cash used in operations was $7,718,000 during the year ended
December 31, 2004 compared to $1,459,000 of cash used in
operations during the year ended December 31, 2003. This
increase was due to an increase in our research and development
efforts and additional personnel.
Net cash used in investing activities was $228,000 during the
year ended December 31, 2004 compared to $72,000 during the
year ended December 31, 2003. This was due to the increased
purchase of property and equipment and leasehold improvements
during 2004.
Net cash provided by financing activities was $23,450,000 during
the year ended December 31, 2004 versus $1,946,000 during
the year ended December 31, 2003. In January 2004, we sold
common stock and warrants to purchase common stock for
approximately $8,057,000, or $7,670,000 net of issuance
costs. In October 2004, we sold common stock and warrants to
purchase common stock for approximately $13,870,000, or
$12,717,000 net of issuance costs. Additionally, we
received approximately $2,863,000 in proceeds from warrant
exercises for the year ended December 31, 2004. During the
year ended December 31, 2003, we received $942,000 from the
issuance of promissory notes, which are no longer outstanding,
and the issuance of common stock upon the exercise of stock
options.
We expect our cash requirements to increase significantly in the
foreseeable future as we continue to increase our research and
development for, seek regulatory approvals of, and develop and
manufacture our current product candidates. As we expand our
research and development efforts and pursue additional product
opportunities, we anticipate significant cash requirements for
hiring of personnel, capital expenditures and investment in
additional internal systems and infrastructure.
The amount and timing of cash requirements will depend on
regulatory and market acceptance of our product candidates, if
any, and the resources we devote to researching, developing,
manufacturing, commercializing and supporting our product
candidates.
We believe that our current cash and cash equivalents will be
sufficient to fund our operations into 2006. Until we can
generate significant cash from our operations, we expect to
continue to fund our operations with existing cash resources
that were primarily generated from the proceeds from our recent
private financing. We
19
may finance future cash needs through the sale of other equity
securities, the exercise of our callable warrants, strategic
collaboration agreements and debt financing. We cannot be
certain that our existing cash and cash equivalents will be
adequate or that additional financing will be available when
needed or that, if available, financing will be obtained on
terms favorable to us or our stockholders. Having insufficient
funds may require us to delay, scale back or eliminate some or
all of our research and development programs or delay the launch
of our product candidates. If we raise additional funds by
issuing equity securities, substantial dilution to existing
stockholders would likely result. If we raise additional funds
by incurring debt financing, the terms of the debt may involve
significant cash payment obligations as well as covenants and
specific financial ratios that may restrict our ability to
operate our business.
Off-Balance Sheet Arrangements As of
December 31, 2004, we did not have any relationships with
unconsolidated entities or financial partnerships, such as
entities often referred to as structured finance or special
purpose entities, which would have been established for the
purpose of facilitating off-balance sheet arrangements or other
contractually narrow or limited purposes. In addition, we do not
engage in trading activities involving non-exchange traded
contracts. As such, we are not materially exposed to any
financing, liquidity, market or credit risk that could arise if
we had engaged in these relationships.
Recent Accounting Pronouncements
See Note 2, Summary of Significant Accounting
Policies Recent Accounting Pronouncements in
the accompanying Notes to Consolidated Financial Statements for
a discussion of recent accounting pronouncements and their
effect, if any, on the Company.
|
|
Item 7. |
Financial Statements. |
Our financial statements are annexed to this report beginning on
page F-1.
|
|
Item 8. |
Changes In and Disagreements With Accountants on
Accounting and Financial Disclosure. |
On March 12, 2004, our Board of Directors voted to replace
the independent accountant that had reported on the financial
statements for Global Yacht Services, Inc., Hall &
Company (Hall). We retained the accounting firm of
Cacciamatta Accountancy Corporation (Cacciamatta) on
March 12, 2004, to make an examination of the financial
statements for the 2002 and 2003 fiscal years. This examination
by Cacciamatta reflected our post-merger structure and our
activities as a biopharmaceutical corporation. We authorized
Hall to respond fully to any inquiries from Cacciamatta and to
make Halls work papers available to Cacciamatta. We did
not have any disagreements with Hall nor did Halls prior
reports contain adverse opinions or disclaimers of opinions.
Hall did not make any negative report regarding our internal
controls, management or prior financial statements prior to its
dismissal.
|
|
Item 8A. |
Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our
management, including our principal executive officer and
principal financial officer, we conducted an evaluation of our
disclosure controls and procedures, as such term is defined
under Rule 13a-15(e) promulgated under the Securities
Exchange Act of 1934, as amended (the Exchange Act). Based on
this evaluation, our principal executive officer and our
principal financial officer concluded that our disclosure
controls and procedures were effective as of the end of the
period covered by this Annual Report.
Changes in Internal Controls Over Financial Reporting
There have been no significant changes in our internal controls
over financial reporting that occurred during the quarter ended
December 31, 2004, that have materially affected, or are
reasonably likely to materially affect our internal control over
financial reporting.
|
|
Item 8B. |
Other Information. |
None.
20
PART III
|
|
Item 9. |
Directors and Executive Officers. |
The information required by this item regarding directors is
incorporated by reference to our Definitive Proxy Statement to
be filed with the Securities and Exchange Commission in
connection with our 2005 Annual Meeting of Stockholders (the
Proxy Statement) under the heading Election of
Directors. The information required by this item regarding
compliance with Section 16(a) of the Securities Exchange
Act of 1934, as amended, is incorporated by reference to the
information under the caption Compliance with
Section 16(a) of the Exchange Act contained in the
Proxy Statement. The information required by this item regarding
our code of ethics is incorporated by reference to the
information under the caption Code of Ethics
contained in our Proxy Statement.
Executive Officers
Jonathan E. Lim, MD (33), President, Chief Executive
Officer and Director. Dr. Lim joined Halozyme in 2003. From
2001 to 2003, Dr. Lim was a management consultant at
McKinsey & Company, where he specialized in the health
care industry, serving a wide range of start-ups to Fortune
500 companies in the biopharmaceutical, medical products,
and payor/provider segments. From 1999 to 2001, Dr. Lim was
a recipient of a National Institutes of Health Postdoctoral
Fellowship, during which time he conducted clinical outcomes
research at Harvard Medical School. He has published articles in
peer-reviewed medical journals such as the Annals of Surgery and
the Journal of Refractive Surgery. Dr. Lims prior
experience also includes two years of clinical training in
general surgery at the New York Hospital-Cornell Medical Center
and Memorial Sloan-Kettering Cancer Center; Founder and
President of a health care software company; Founding
Editor-in-Chief of the McGill Journal of Medicine; and basic
science and clinical research at the Salk Institute for
Biological Studies and Massachusetts Eye and Ear Infirmary.
Dr. Lim is currently a Californialicensed physician
and member of the strategic planning committee of the American
Medical Association. He earned his BS, with honors, and MS
degrees in molecular biology from Stanford University, his MD
degree from McGill University, and his MPH degree in health care
management from Harvard University.
Gregory I. Frost, PhD (33), Vice President &
Chief Scientific Officer and Director. Dr. Frost joined
Halozyme in 1999 and has spent more than ten years researching
the hyaluronidase family of enzymes. From 1998 to 1999, he was a
Senior Research Scientist at the Sidney Kimmel Cancer Center
(SKCC), where he focused much of his work developing the
hyaluronidase technology. Prior to SKCC, his research in the
Department of Pathology at the University of California,
San Francisco, led directly to the purification, cloning,
and characterization of the human hyaluronidase gene family, and
the discovery of several metabolic disorders. He has authored 13
scientific peer-reviewed and invited articles in the
Hyaluronidase field and is an inventor on numerous patents.
Dr. Frosts prior experience includes serving as a
scientific consultant to a number of biopharmaceutical
companies, including Q-Med (SE), Biophausia AB (SE), and Active
Biotech (SE). Dr. Frost is registered to practice before
the US Patent Trademark Office, and earned his BA in
biochemistry and molecular biology from the University of
California, Santa Cruz, and his PhD in the department of
Pathology at the University of California, San Francisco,
where he was an ARCS-Scholar.
David A. Ramsay, MBA (40), Vice President &
Chief Financial Officer. Mr. Ramsay joined Halozyme in 2003
and brings 17 years of corporate financial experience
spanning several industries. From 2000 to 2003, he was Vice
President, Chief Financial Officer of Lathian Systems, a
provider of technology-based sales solutions for the life
sciences industry. Prior to Lathian, Mr. Ramsay was the
Vice President, Treasurer of ICN Pharmaceuticals, a
multinational, specialty pharmaceutical company. Mr. Ramsay
joined ICN in 1998 from ARCO, where he spent four years in
various financial roles, most recently serving as Manager of
Financial Planning & Analysis for the companys
1,700-station West Coast Retail Marketing Network. Prior to
ARCO, he served as Vice President, Controller for Security
Pacific Asian Bank, a subsidiary of Security Pacific
Corporation. He began his career as an Auditor at
Deloitte & Touche, where he obtained his CPA license.
Mr. Ramsay also serves on the Board of Directors for Axxora
Life Sciences, Inc., a privately held, worldwide research
reagent company. Mr. Ramsay graduated from the University
of California, Berkeley, with
21
a BS degree in Business Administration and earned his MBA degree
with a dual major in Finance and Strategic Management from The
Wharton School at the University of Pennsylvania.
Don A. Kennard (58), Vice President of Regulatory
Affairs & Quality Assurance. Mr. Kennard joined
Halozyme in 2004 and brings to Halozyme nearly 30 years of
professional senior management experience in the fields of
regulatory affairs (RA), clinical programs, and quality
assurance (QA). He has worked directly with the U.S. Food
and Drug Administration (FDA), as well as regulatory authorities
of various foreign ministries of health, to secure registration,
authorize commercialization, and successfully implement quality
programs, for a broad range and extensive number of product
approvals across pharmaceuticals, biologics, medical devices,
and diagnostics. Prior to Halozyme, Mr. Kennard was Vice
President of Worldwide RA/ QA at Quidel, Inc., a manufacturer of
diagnostic products, where he led the RA/ QA and Clinical
functions, while also establishing a Quality System CE marking
program that enabled Quidel to expand and sustain sales in the
European Union. From 1991 to 2001, he was Vice President of RA/
QA/ R&D for Nobel Biocare, Inc. and Steri-Oss (acquired by
Nobel Biocare), where he directed all regulatory affairs,
quality assurance, clinical trials, and R&D activities. From
1981 to 1991, Mr. Kennard was Director of RA/ QA at
Allergan, Inc., where he directed regulatory affairs, quality
assurance and quality control in the development and manufacture
of prescription and OTC ophthalmic and dermatological drugs,
injectable drugs, biotechnology products, and ophthalmic
products. Prior to Allergan, he was Director of Quality Control
at B. Braun. Mr. Kennard holds a BS degree in Microbiology
and a Regulatory Affairs Certificate.
Carolyn M. Rynard, PhD (50), Vice President of Product
Development & Manufacturing. Dr. Rynard joined
Halozyme in 2003. Dr. Rynards career in drug
development spans 20 years in the pharmaceutical and
biotech industries. Her broad experience includes project
management, formulation, manufacturing, clinical supplies,
validation, medical devices, and quality systems. From 2001 to
2003, Dr. Rynard was Vice President of Product Development
at Medinox, Inc., where she was directly responsible for
Medinoxs Chemistry, Manufacturing, and Control,
formulation, analytical methods, and specification development.
From 1994 to 2001, she worked for Amylin Pharmaceuticals, Inc.,
a San Diego, California-based pharmaceutical company where
she held various positions of increasing responsibility, serving
most recently as Senior Director of Product Development. At
Amylin, Dr. Rynard managed seven functional areas and
wrote CMC sections for US NDAs and investigational new drug
applications; European marketing authorization applications and
clinical trial exemptions; as well as device 510(k) and CE mark
technical files. Prior to joining Amylin, Dr. Rynard held
various R&D positions at Baxter Healthcare and at DuPont.
Dr. Rynard earned her BSc degree in Chemistry and
Biochemistry from the University of Toronto, and her PhD in
Physical and Organic Chemistry from Stanford University.
Mark S. Wilson, MBA (44), Vice President of Business
Development. Mr. Wilson joined Halozyme in 2003 and has
spent more than 15 years in the
biotechnology/pharmaceutical industry, having most recently
served as Founder and CEO of Biophysica Science, Inc. and
Director of Strategic External Alliance Management at Pfizer
Global R&D La Jolla from 2001 to 2003. From
1996 to 2001, Mr. Wilson was Associate Director of
Materials at Agouron Pharmaceuticals, Inc., where he identified
and negotiated international supply agreements in excess of
$120 million annually and served as Materials Manager for
the launch of Viracept. From 1991 to 1996, Mr. Wilson was
an Associate Director at Gensia Laboratories, Ltd., where he
directed a wide range of business operations. Prior experience
also includes various management and operational roles at
Hybritech, Ferro Corporation, and TRW, Inc. Mr. Wilson
earned his BS degree in engineering from the University of
California, Berkeley, and his MBA degree at the Anderson
Graduate School of Management at the University of California,
Los Angeles.
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Item 10. |
Executive Compensation. |
The information required by this item is incorporated by
reference to the information under the caption Executive
Compensation contained in the Proxy Statement.
22
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Item 11. |
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters. |
The information required by this item is incorporated by
reference to the information under the caption Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters contained in the Proxy
Statement.
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Item 12. |
Certain Relationships and Related Transactions. |
The information required by this item is incorporated by
reference to the information under the caption Certain
Relationships and Related Transactions contained in the
Proxy Statement.
The following documents are filed as part of this Annual Report:
(a) Financial Statements:
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Page | |
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Report of Independent Registered Accounting Firm
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F-1 |
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Consolidated Balance Sheet at December 31, 2004
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F-2 |
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Consolidated Statements of Operations for the Years Ended
December 31, 2004 and 2003 and from Inception to
December 31, 2004
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F-3 |
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Consolidated Statements of Stockholders Equity from
Inception to December 31, 2004
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F-4 |
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Consolidated Statements of Cash Flows for the Years Ended
December 31, 2004 and 2003 and from Inception to
December 31, 2004
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F-5 |
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Notes to Consolidated Financial Statements
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F-6 |
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(b) Exhibits:
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Exhibit | |
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Title |
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2 |
.1 |
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Agreement of Merger between DeliaTroph Pharmaceuticals, Inc. and
Registrant, dated January 28, 2004(1) |
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3 |
.1 |
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Amended and Restated Articles of Incorporation(1) |
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3 |
.2 |
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Bylaws(2) |
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10 |
.1 |
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License Agreement between University of Connecticut and
Registrant, dated November 15, 2002(3) |
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10 |
.2* |
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Agreement for Services between Avid Bioservices, Inc. and
Registrant, dated November 19, 2003(3) |
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10 |
.3* |
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Distribution Agreement between MidAtlantic Diagnostics, Inc. and
Registrant, dated January 30, 2004(3) |
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10 |
.4* |
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Distribution Agreement between MediCult AS and Registrant, dated
February 9, 2004(3) |
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10 |
.5* |
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Distribution Agreement between Cook Ob/Gyn Incorporated and
Registrant, dated April 13, 2004(3) |
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10 |
.6 |
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2004 Stock Plan and Form of Option Agreement thereunder(4) |
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10 |
.7 |
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Form of Indemnity Agreement for Directors and Executive
Officers(4) |
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10 |
.8* |
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Exclusive Distribution Agreement between Baxter Healthcare and
Registrant, dated August 13, 2004(5) |
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10 |
.9 |
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Form of Callable Stock Purchase Warrant(4) |
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10 |
.10 |
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Securities Purchase Agreement between Registrant and the other
signatories thereto, dated as of October 12, 2004(6) |
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10 |
.11 |
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Form of Common Stock Purchase Warrant(6) |
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10 |
.12 |
|
Registration Rights Agreement between Registrant and the other
signatories thereto, dated as of October 12, 2004(6) |
23
|
|
|
|
|
Exhibit | |
|
Title |
| |
|
|
|
|
10 |
.13* |
|
Commercial Supply Agreement with Avid Bioservices, Inc. and
Registrant, dated February 16, 2005(7) |
|
|
31 |
.1 |
|
Certification of CEO pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
|
|
31 |
.2 |
|
Certification of CFO pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002 |
|
|
32 |
.1 |
|
Certification of CEO pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
|
|
32 |
.2 |
|
Certification of CFO pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 |
|
|
(1) |
Incorporated by reference to the Registrants Information
Statement on Schedule 14C filed on February 17, 2004. |
|
(2) |
Incorporated by reference to the Registrants Current
Report on Form 8-K, filed December 14, 2004. |
|
(3) |
Incorporated by reference to the Registrants Registration
Statement on Form SB-2 filed with the Commission on
April 23, 2004. |
|
(4) |
Incorporated by reference to the Registrants amendment
number two to the Registration Statement on Form SB-2 filed
with the Commission on July 23, 2004. |
|
(5) |
Incorporated by reference to the Registrants Quarterly
Report on Form 10-QSB, filed November 12, 2004. |
|
(6) |
Incorporated by reference to the Registrants Current
Report on Form 8-K, filed October 15, 2004. |
|
(7) |
Incorporated by reference to the Registrants Current
Report on Form 8-K, filed February 22, 2005. |
|
|
|
|
* |
Confidential treatment has been requested for certain portions
of this exhibit. These portions have been omitted from this
agreement and have been filed separately with the Securities and
Exchange Commission. |
|
|
Item 14. |
Principal Accountant Fees and Services. |
The information required by this item is incorporated by
reference to the information under the caption Principal
Accountant Fees and Services contained in the Proxy
Statement.
24
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned in the City of San Diego, on
March 11, 2005.
|
|
|
Halozyme Therapeutics, Inc., |
|
a Nevada corporation |
|
|
|
|
|
Jonathan E. Lim, MD |
|
President, Chief Executive Officer, |
|
Chairman of the Board |
Date: March 11, 2005
POWER OF ATTORNEY
Know all persons by these presents, that each person whose
signature appears below constitutes and appoints Jonathan E. Lim
and David A. Ramsay, and each of them, as his true and lawful
attorneys-in-fact and agents, with full power of substitution
and resubstitution, for him and in his name, place, and stead,
in any and all capacities, to sign 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, granting unto said
attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing
requisite and necessary to be done in connection therewith, as
fully to all intents and purposes as he might or could do in
person, hereby ratifying and confirming that all said
attorneys-in-fact and agents, or any of them or their or his
substitute or substituted, may lawfully do or cause to be done
by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, as
amended, this Annual Report has been signed by the following
persons in the capacities and on the dates indicated.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Jonathan E. Lim, M.D.
Jonathan
E. Lim, M.D. |
|
Chairman of the Board, President and Chief Executive Officer
(Principal Executive Officer) |
|
March 11, 2005 |
|
/s/ David A. Ramsay
David
A. Ramsay |
|
Secretary and Chief Financial Officer (Principal Financial and
Accounting Officer) |
|
March 11, 2005 |
|
/s/ Gregory I. Frost, Ph.D.
Gregory
I. Frost, Ph.D. |
|
Vice President and Chief Scientific Officer, Director |
|
March 11, 2005 |
|
/s/ Kenneth J. Kelley
Kenneth
J. Kelley |
|
Director |
|
March 11, 2005 |
|
/s/ Robert L. Engler, M.D.
Robert
L. Engler, M.D. |
|
Director |
|
March 11, 2005 |
|
/s/ John S. Patton, Ph.D.
John
S. Patton, Ph.D. |
|
Director |
|
March 11, 2005 |
25
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
The Board of Directors and Shareholders
Halozyme Therapeutics, Inc.
We have audited the accompanying consolidated balance sheet of
Halozyme Therapeutics, Inc. and subsidiary (a development stage
company) (the Company) as of December 31, 2004,
and the related consolidated statements of operations,
stockholders equity and cash flows for each of the years
in the two year period ended December 31, 2004, and for the
period from inception (February 26, 1998) to
December 31, 2004. These financial statements are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). 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 provide a
reasonable basis for our opinion.
In our opinion, such consolidated financial statements present
fairly, in all material respects, the financial position of the
Company as of December 31, 2004, and the results of its
operations and its cash flows for each of the years in the two
year period ended December 31, 2004, and for the period
from inception (February 26, 1998) to December 31,
2004, in conformity with accounting principles generally
accepted in the United States of America.
|
|
|
|
/s/ |
CACCIAMATTA ACCOUNTANCY |
Irvine, California
February 18, 2005
F-1
HALOZYME THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEET
As of December 31, 2004
|
|
|
|
|
|
ASSETS |
CURRENT ASSETS:
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
16,007,714 |
|
Inventory
|
|
|
51,821 |
|
Prepaid expenses and other current assets
|
|
|
86,087 |
|
|
|
|
|
|
Total current assets
|
|
|
16,145,622 |
|
PROPERTY AND EQUIPMENT, net
|
|
|
235,505 |
|
OTHER ASSETS
|
|
|
22,544 |
|
|
|
|
|
|
Total Assets
|
|
$ |
16,403,671 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
CURRENT LIABILITIES:
|
|
|
|
|
Accounts payable
|
|
$ |
1,487,243 |
|
Accrued expenses
|
|
|
92,170 |
|
|
|
|
|
|
Total current liabilities
|
|
|
1,579,413 |
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
STOCKHOLDERS EQUITY:
|
|
|
|
|
Common stock, $0.001 par value; 100,000,000 shares
authorized; 49,202,083 shares issued and outstanding
|
|
|
49,202 |
|
Additional paid-in-capital
|
|
|
27,846,937 |
|
Deficit accumulated during the development stage
|
|
|
(13,071,881 |
) |
|
|
|
|
|
Total Stockholders Equity
|
|
|
14,824,258 |
|
|
|
|
|
|
Total Liabilities and Stockholders Equity
|
|
$ |
16,403,671 |
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-2
HALOZYME THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended December 31, 2004 and 2003 and
From Inception to December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative | |
|
|
|
|
|
|
from Inception | |
|
|
|
|
|
|
(February 26, 1998) | |
|
|
2004 | |
|
2003 | |
|
to 2004 | |
|
|
| |
|
| |
|
| |
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$ |
6,517,254 |
|
|
$ |
1,145,420 |
|
|
$ |
8,927,298 |
|
General and administrative
|
|
|
2,570,595 |
|
|
|
576,452 |
|
|
|
3,771,740 |
|
|
|
|
|
|
|
|
|
|
|
Total Expenses
|
|
|
9,087,849 |
|
|
|
1,721,872 |
|
|
|
12,699,038 |
|
Other income (expense), net
|
|
|
(3,527 |
) |
|
|
(393,153 |
) |
|
|
(372,843 |
) |
|
|
|
|
|
|
|
|
|
|
LOSS BEFORE INCOME TAXES
|
|
|
(9,091,376 |
) |
|
|
(2,115,025 |
) |
|
|
(13,071,881 |
) |
Income Tax Expense
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$ |
(9,091,376 |
) |
|
$ |
(2,115,025 |
) |
|
$ |
(13,071,881 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted
|
|
$ |
(0.26 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per share, basic and diluted
|
|
|
35,411,127 |
|
|
|
8,196,362 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-3
HALOZYME THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
From Inception (February 26, 1998) to December 31,
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit | |
|
|
|
|
Common Stock | |
|
|
|
Accumulated | |
|
Total | |
|
|
| |
|
Paid-In | |
|
During | |
|
Shareholders | |
|
|
Shares | |
|
Amount | |
|
Capital | |
|
Development | |
|
Equity | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(All share information reflects post-split amounts) | |
Initial capitalization
|
|
|
|
|
|
$ |
|
|
|
$ |
10,956 |
|
|
$ |
|
|
|
$ |
10,956 |
|
Contributed capital net
|
|
|
|
|
|
|
|
|
|
|
132,819 |
|
|
|
|
|
|
|
132,819 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41,884 |
) |
|
|
(41,884 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, DECEMBER 31, 1999
|
|
|
|
|
|
|
|
|
|
|
143,775 |
|
|
|
(41,884 |
) |
|
|
101,891 |
|
Contributed capital net
|
|
|
|
|
|
|
|
|
|
|
78,473 |
|
|
|
|
|
|
|
78,473 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(125,210 |
) |
|
|
(125,210 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, DECEMBER 31, 2000
|
|
|
|
|
|
|
|
|
|
|
222,248 |
|
|
|
(167,094 |
) |
|
|
55,154 |
|
Issuance of common stock for cash, February 22, 2001
|
|
|
4,275,000 |
|
|
|
4,275 |
|
|
|
|
|
|
|
|
|
|
|
4,275 |
|
Issuance of common stock for cash, May 4, 2001
|
|
|
21,376 |
|
|
|
21 |
|
|
|
|
|
|
|
|
|
|
|
21 |
|
Issuance of common stock for cash, May 25, 2001
|
|
|
1,187,498 |
|
|
|
1,188 |
|
|
|
|
|
|
|
|
|
|
|
1,188 |
|
Contributed capital net
|
|
|
|
|
|
|
|
|
|
|
796,225 |
|
|
|
|
|
|
|
796,225 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(563,621 |
) |
|
|
(563,621 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, DECEMBER 31, 2001
|
|
|
5,483,874 |
|
|
|
5,484 |
|
|
|
1,018,473 |
|
|
|
(730,715 |
) |
|
|
293,242 |
|
Issuance of common stock for cash, May 10, 2002
|
|
|
2,712,488 |
|
|
|
2,712 |
|
|
|
124,188 |
|
|
|
|
|
|
|
126,900 |
|
Contributed capital net
|
|
|
|
|
|
|
|
|
|
|
335,063 |
|
|
|
|
|
|
|
335,063 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,134,765 |
) |
|
|
(1,134,765 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, DECEMBER 31, 2002
|
|
|
8,196,362 |
|
|
|
8,196 |
|
|
|
1,477,724 |
|
|
|
(1,865,480 |
) |
|
|
(379,560 |
) |
Contributed capital net
|
|
|
|
|
|
|
|
|
|
|
2,868,392 |
|
|
|
|
|
|
|
2,868,392 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,115,025 |
) |
|
|
(2,115,025 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, DECEMBER 31, 2003
|
|
|
8,196,362 |
|
|
|
8,196 |
|
|
|
4,346,116 |
|
|
|
(3,980,505 |
) |
|
|
373,807 |
|
Redemption of common stock, March 10, 2004
|
|
|
(4,296,362 |
) |
|
|
(4,296 |
) |
|
|
(38,007 |
) |
|
|
|
|
|
|
(42,303 |
) |
Issuance of shares for Merger with DeliaTroph net
|
|
|
35,521,906 |
|
|
|
35,522 |
|
|
|
7,876,927 |
|
|
|
|
|
|
|
7,912,449 |
|
Exercise of warrants
|
|
|
282,780 |
|
|
|
283 |
|
|
|
128,716 |
|
|
|
|
|
|
|
128,999 |
|
Exercise of callable warrants, net
|
|
|
1,571,682 |
|
|
|
1,571 |
|
|
|
2,726,036 |
|
|
|
|
|
|
|
2,727,607 |
|
Issuance of common stock for cash, net
|
|
|
7,925,715 |
|
|
|
7,926 |
|
|
|
12,708,949 |
|
|
|
|
|
|
|
12,716,875 |
|
Issuance of common stock options to consultants
|
|
|
|
|
|
|
|
|
|
|
98,200 |
|
|
|
|
|
|
|
98,200 |
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,091,376 |
) |
|
|
(9,091,376 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE, DECEMBER 31, 2004
|
|
|
49,202,083 |
|
|
$ |
49,202 |
|
|
$ |
27,846,937 |
|
|
$ |
(13,071,881 |
) |
|
$ |
14,824,258 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-4
HALOZYME THERAPEUTICS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2004 and 2003 and
From Inception to December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative from | |
|
|
|
|
|
|
Inception | |
|
|
|
|
|
|
(February 26, 1998) | |
|
|
2004 | |
|
2003 | |
|
to 2004 | |
|
|
| |
|
| |
|
| |
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(9,091,376 |
) |
|
$ |
(2,115,025 |
) |
|
$ |
(13,071,881 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
123,350 |
|
|
|
75,726 |
|
|
|
332,240 |
|
|
Issuance of common stock for goods and services
|
|
|
98,200 |
|
|
|
85,388 |
|
|
|
200,445 |
|
|
Issuance of common stock for license
|
|
|
|
|
|
|
|
|
|
|
2,330 |
|
|
Issuance of common stock for accrued interest on notes
|
|
|
|
|
|
|
87,510 |
|
|
|
99,764 |
|
|
Beneficial conversion feature on 2003 notes
|
|
|
|
|
|
|
306,754 |
|
|
|
306,754 |
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
|
(51,821 |
) |
|
|
|
|
|
|
(51,821 |
) |
|
|
Prepaid expenses and other assets
|
|
|
(95,868 |
) |
|
|
(5,263 |
) |
|
|
(108,631 |
) |
|
|
Accounts payable and accrued expenses
|
|
|
1,299,859 |
|
|
|
105,554 |
|
|
|
1,573,299 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
(7,717,656 |
) |
|
|
(1,459,356 |
) |
|
|
(10,717,501 |
) |
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(227,951 |
) |
|
|
(72,460 |
) |
|
|
(544,646 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(227,951 |
) |
|
|
(72,460 |
) |
|
|
(544,646 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of notes
|
|
|
|
|
|
|
842,000 |
|
|
|
1,272,000 |
|
Proceeds from issuance of common stock
|
|
|
|
|
|
|
100,000 |
|
|
|
110,956 |
|
Proceeds from exercise of warrants net
|
|
|
2,862,720 |
|
|
|
|
|
|
|
2,862,720 |
|
Contributed capital net
|
|
|
7,870,146 |
|
|
|
1,004,486 |
|
|
|
10,307,310 |
|
Proceeds from issuance of common stock net
|
|
|
12,716,875 |
|
|
|
|
|
|
|
12,716,875 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
23,449,741 |
|
|
|
1,946,486 |
|
|
|
27,269,861 |
|
NET INCREASE IN CASH AND CASH EQUIVALENTS
|
|
|
15,504,134 |
|
|
|
414,670 |
|
|
|
16,007,714 |
|
CASH AND CASH EQUIVALENTS, beginning of period
|
|
|
503,580 |
|
|
|
88,910 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS, end of period
|
|
$ |
16,007,714 |
|
|
$ |
503,580 |
|
|
$ |
16,007,714 |
|
|
|
|
|
|
|
|
|
|
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for income taxes
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Non cash investing and financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of contributed capital to common stock
|
|
$ |
7,870,146 |
|
|
$ |
|
|
|
$ |
10,307,310 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of notes payable to common stock
|
|
$ |
|
|
|
$ |
1,371,764 |
|
|
$ |
1,371,764 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Series C preferred stock to common stock
|
|
$ |
1,004,486 |
|
|
$ |
|
|
|
$ |
1,004,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for property and equipment
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A preferred stock issued for property and equipment
|
|
$ |
|
|
|
$ |
|
|
|
$ |
20,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued cost for redemption of unexercised callable warrants
|
|
$ |
6,114 |
|
|
$ |
|
|
|
$ |
6,114 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
F-5
Halozyme Therapeutics, Inc.
(A Development Stage Company)
Notes to Consolidated Financial Statements
|
|
1. |
Organization and Business |
Halozyme is a development stage biopharmaceutical company
dedicated to the development and commercialization of
recombinant human enzymes for the infertility, ophthalmology,
and oncology markets.
The Companys operations to date have been limited to
organizing and staffing the Company, acquiring, developing and
securing its technology and undertaking product development for
a limited number of product candidates. As the Company has not
begun principal operations of commercializing a product
candidate, the financial statements have been presented as a
development stage company.
DeliaTroph Pharmaceuticals, Inc. (DeliaTroph), our
predecessor company, was incorporated on February 26, 1998.
Effective March 11, 2004, DeliaTroph (which was doing
business at the time as Hyalozyme Therapeutics, Inc.), Global
Yacht Services, Inc. (Global), a publicly traded
Nevada corporation and Hyalozyme Acquisition Corporation
(Merger Sub), a wholly owned subsidiary of Global,
completed a transaction in which Merger Sub merged with and into
DeliaTroph (the Merger), with DeliaTroph surviving
as a wholly owned subsidiary of Global.
Although Global acquired DeliaTroph as a result of the Merger,
the former shareholders of DeliaTroph received a majority of the
voting interest in the combined enterprise as consideration for
entering into the Merger. Additionally, the Merger resulted in
DeliaTrophs management and Board of Directors assuming
operational control of Global.
The following summary lists the structure of the Merger and
matters completed in connection therewith:
|
|
|
|
|
On January 28, 2004, pursuant to an investment round
completed simultaneously with the signing of the definitive
Merger agreement, DeliaTroph raised equity capital of
approximately $8.1 million. |
|
|
|
The stockholders of Global amended and restated Globals
Articles of Incorporation to change Globals corporate name
to Halozyme Therapeutics, Inc., increased the authorized number
of shares of common stock to 100 million, and authorized
20 million shares of preferred stock. |
|
|
|
Global, now named Halozyme Therapeutics, Inc., issued
35,521,906 shares of its restricted common stock, 6,380,397
options and 11,742,665 warrants to purchase shares of its common
stock to the shareholders of DeliaTroph in exchange for 100% of
their issued and outstanding common stock, options and warrants
to purchase DeliaTrophs common stock. |
|
|
|
A total of 4,296,362 shares of Global, now named Halozyme
Therapeutics, Inc., outstanding common stock were redeemed by
Global from three stockholders in exchange for $42,303, or
approximately $0.01 per share. |
|
|
|
Upon completion of the Merger, the pre-Merger stockholders of
Global owned approximately 10% of the issued and outstanding
shares of Halozyme Therapeutics, Inc., based on
39,421,906 shares outstanding after the Merger. |
The full text of the Merger Agreement may be found in
Exhibit A to Global Yachts definitive
Schedule 14C Information Statement, as filed with the
Securities and Exchange Commission on February 17, 2004.
The Merger has been treated as a re-capitalization of DeliaTroph
and, accordingly, the financial statements reflect the
historical activity of DeliaTroph with the capital structure of
Global. Prior to the Merger, Global had limited operations.
F-6
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
|
|
2. |
Summary of Significant Accounting Policies |
The accompanying consolidated financial statements have been
prepared in accordance with accounting principles generally
accepted in the U.S. and with the rules and regulations of the
Securities and Exchange Commission related to an annual report
on Form 10-KSB.
The preparation of financial statements in conformity with
accounting principles generally accepted in the
U.S. requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities as
well as disclosures of contingent assets and liabilities at the
date of the financial statements. Estimates also affect the
reported amounts of revenues and expenses during the reporting
period. Actual results could differ from those estimates.
Certain amounts in the prior year financial statements have been
reclassified to conform to the current year presentation.
|
|
|
Cash and Cash Equivalents |
Cash and cash equivalents consist of highly liquid investments
with maturities of three months or less from the original
purchase date.
|
|
|
Concentration of Credit Risk |
Financial instruments that potentially subject the Company to a
significant concentration of credit risk consist of cash and
cash equivalents. The Company maintains its cash balances with
one major commercial bank. The balances are insured by the
Federal Deposit Insurance Corporation up to $100,000.
Inventories are stated at lower of cost or market and consist of
raw materials and work in process used in the manufacture of the
Companys Cumulase product. Inventories are valued using a
standard cost approach that approximates the first-in, first-out
method. The inventory of work in process represents those units
the Company expects to sell in the European Union or to be used
in sampling programs.
Property and equipment are recorded at cost. Equipment and
furniture are depreciated using the straight-line method over
their estimated useful lives of three years and leasehold
improvements are amortized using the straight-line method over
the estimated useful life of the asset or the lease term,
whichever is shorter.
|
|
|
Impairment of Long-Lived Assets |
The Company accounts for the impairment and disposition of
long-lived assets in accordance with Statements of Financial
Accounting Standards (SFAS) No. 144,
Accounting for the Impairment or Disposal of Long-Lived
Assets. In accordance with SFAS No. 144,
long-lived assets are reviewed for events of changes in
circumstances, which indicate that their carrying value may not
be recoverable. At December 31, 2004, the Company believes
there has been no impairment of the value of such assets.
|
|
|
Research and Development Costs |
Costs and expenses that can be clearly identified as research
and development are charged to expense as incurred in accordance
with FASB statement No. 2, Accounting for Research
and Development Costs.
F-7
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
In December 2002, Statement of Financial Accounting Standards
(SFAS) No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure
an amendment of FASB Statement No. 123 was issued.
SFAS No. 148 provides alternative methods of
transition for a voluntary change to the fair value based method
of accounting for stock-based employee compensation from the
intrinsic value-based method of accounting prescribed by
Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees. In
addition, SFAS No. 148 amends the disclosure
requirements of SFAS No. 123, Accounting for
Stock-Based Compensation. The Company adopted the disclosure
requirements of SFAS No. 148 effective
December 31, 2002. As allowed by SFAS No. 123,
the Company has elected to continue to apply the intrinsic
value-based method of accounting prescribed in APB No. 25
and, accordingly, does not recognize compensation expense for
stock option grants made to employees at an exercise price equal
to or in excess of the fair value of the stock at the date of
grant. Deferred compensation is recognized and amortized on an
accelerated basis in accordance with Financial Accounting
Standards Board Interpretation No. 28, Accounting for
Stock Appreciation Rights and Other Variable Stock Option or
Award Plans, over the vesting period of the related options.
Had compensation cost for the Companys outstanding
employee stock options been determined based on the fair value
at the grant dates for those options consistent with
SFAS No. 123, the Companys net loss and basic
and diluted net loss per share, would have been changed to the
following pro forma amounts:
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
In thousands | |
Net loss, as reported
|
|
$ |
(9,091 |
) |
|
$ |
(2,115 |
) |
Deduct: Total stock-based employee Compensation expense
determined under Fair value based method for all awards
|
|
|
(1,619 |
) |
|
|
(149 |
) |
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(10,710 |
) |
|
$ |
(2,264 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and diluted, as reported
|
|
$ |
(0.26 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
Pro forma net loss per share, basic and diluted
|
|
$ |
(0.30 |
) |
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
SFAS No. 123 pro forma information regarding net loss
is required by SFAS No. 123, and has been determined
as if the Company had accounted for its stock-based employee
compensation under the fair value method prescribed in
SFAS No. 123. The fair value of the options was
estimated at the date of grant using the Black-Scholes pricing
model with the following assumptions for the year ended
December 31, 2004 and 2003: weighted-average risk-free
interest rate of 3.0%; a dividend yield of 0%; a stock price
volatility of 100%; and a weighted-average life of the option of
48 months.
The effects of applying SFAS No. 123 in this pro forma
disclosure are not indicative of future amounts. Stock option
grants are expensed over their respective vesting periods.
The Company accounts for options issued to nonemployees under
SFAS No. 123 and Emerging Issues Task Force
(EITF) Issue 96-18, Accounting for Equity
Investments that are Issued to Other than Employees for
Acquiring or in Conjunction with Selling Goods or Services.
As such, the value of such options is periodically remeasured
and income or expense is recognized during their vesting terms.
In accordance with SFAS No. 128, Earnings Per
Share, and SEC Staff Accounting Bulletin (SAB)
No. 98, basic net loss per common share is computed by
dividing net loss for the period by the weighted average number
of common shares outstanding during the period. Under
SFAS No. 128, diluted net income
F-8
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
(loss) per share is computed by dividing the net income (loss)
for the period by the weighted average number of common and
common equivalent shares, such as stock options and warrants,
outstanding during the period. Such common equivalent shares
have not been included in the Companys computation of net
loss per share as their effect would have been anti-dilutive.
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Numerator Net loss
|
|
$ |
(9,091,376 |
) |
|
$ |
(2,115,025 |
) |
|
|
|
|
|
|
|
Denominator Weighted average shares outstanding
|
|
|
35,411,127 |
|
|
|
8,196,362 |
|
|
|
|
|
|
|
|
Net loss per share
|
|
$ |
(0.26 |
) |
|
$ |
(0.26 |
) |
|
|
|
|
|
|
|
Incremental common shares (not included because of their
anti-dilutive nature)
|
|
|
|
|
|
|
|
|
|
Stock options
|
|
|
8,700,397 |
|
|
|
21,697,371 |
|
|
Stock warrants
|
|
|
11,886,346 |
|
|
|
11,316,033 |
|
|
|
|
|
|
|
|
|
Potential common equivalents
|
|
|
20,586,743 |
|
|
|
33,013,404 |
|
|
|
|
|
|
|
|
Comprehensive income (loss) is defined as all changes in a
companys net assets, except changes resulting from
transactions with shareholders. At December 31, 2004 and
2003, the Company has no reportable differences between net loss
and comprehensive loss.
The preparation of consolidated financial statements in
conformity with accounting principles generally accepted in the
United States requires management to make estimates and
assumptions that affect the amounts reported in the
Companys consolidated financial statements and
accompanying notes. On an ongoing basis, the Company evaluates
its estimates and judgments, which are based on historical and
anticipated results and trends and on various other assumptions
that the Company believes to be reasonable under the
circumstances. By their nature, estimates are subject to an
inherent degree of uncertainty and, as such, actual results may
differ from the Companys estimates.
|
|
|
Recent Accounting Pronouncements |
On December 16, 2004 the FASB issued
SFAS No. 123R, Share-Based Payment, which
is an amendment to SFAS No. 123, Accounting for
Stock-Based Compensation. This new standard eliminates the
ability to account for share-based compensation transactions
using Accounting Principles Board, or APB, Opinion No. 25,
Accounting for Stock Issued to Employees, and
generally requires such transactions be accounted for using a
fair-value-based method and the resulting cost recognized in our
financial statements. This new standard is effective for awards
that are granted, modified or settled in cash in interim and
annual periods beginning after June 15, 2005,
December 15, 2005 for small business issuers. In addition,
this statement will apply to unvested options granted prior to
the effective date. The Company will adopt this new standard
effective for the first fiscal quarter of 2006 and it has not
yet determined what impact this standard will have on its
financial position or results of operations.
In November 2004, the FASB issued SFAS No. 151,
Inventory Costs: an amendment of ARB No. 43,
Chapter 4, to clarify the accounting for abnormal
amounts of idle facility expense, freight, handling costs and
wasted material. SFAS No. 151 is effective for
inventory costs incurred during fiscal years beginning after
F-9
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
June 15, 2005. We do not believe the provisions of
SFAS No. 151, when applied, will have a material
impact on our financial position or results of operations.
Inventories are stated at the lower of cost or market and
consist of raw materials of $22,870 and work in process of
$28,951 used in the manufacture of the Companys Cumulase
product. Inventories are valued using a standard cost approach
that approximates the first-in, first-out method. The inventory
of work in process represents those units the Company expects to
sell in the European Union or to be used in sampling programs.
|
|
4. |
Property and Equipment |
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Research equipment
|
|
$ |
333,403 |
|
|
$ |
195,534 |
|
Office equipment and furniture
|
|
|
102,775 |
|
|
|
59,687 |
|
Leasehold improvements
|
|
|
131,567 |
|
|
|
84,573 |
|
|
|
|
|
|
|
|
|
|
|
567,745 |
|
|
|
339,794 |
|
Less accumulated depreciation and amortization
|
|
|
(332,240 |
) |
|
|
(208,890 |
) |
|
|
|
|
|
|
|
|
|
$ |
235,505 |
|
|
$ |
130,904 |
|
|
|
|
|
|
|
|
Depreciation and amortization expense totaled $123,350 in 2004
and $75,726 in 2003.
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Other accrued expenses
|
|
|
20,065 |
|
|
|
11,000 |
|
Accrued vacation payable
|
|
|
72,105 |
|
|
|
39,162 |
|
|
|
|
|
|
|
|
|
|
$ |
92,170 |
|
|
$ |
50,162 |
|
|
|
|
|
|
|
|
Issuance of Common Stock In March 1999, the
Company issued 2,078,662 shares of common stock for $10,956
in goods and services. In January 2000, the Company issued
2,078,662 shares of common stock for $10,956 in cash. In
August 2000, the Company issued 442,267 shares of common
stock in exchange for a license valued at $2,330. Of the common
stock 4,157,324 shares were sold to founders of the Company.
In January 2004, the purchasers of the Series C stock
exercised their option and the Company issued
15,304,804 shares of common stock in a private placement,
at $0.4647 per share, generating approximately
$7.1 million in gross proceeds. In addition, the Company
sold 756,286 shares of common stock for $1.25 per
share, or $0.9 million in gross proceeds. Net proceeds from
this transaction totaled approximately $7.9 million. In
March 2004, the Company issued 3,900,000 shares of common
stock as a result of the reverse Merger. In October 2004, the
Company issued 7,925,715 shares of common stock in a
private placement at a price per share of $1.75, generating
approximately $12.7 million in net proceeds.
Issuance of Common Stock Options for Services
In September 2002, the Company issued 7,897 common stock options
for consulting services valued at $500. In January 2003, the
Company issued 39,488 common stock options for consulting
services valued at $2,500. In April 2003, the Company issued
39,488 common stock options for consulting services valued at
$2,500. In October 2003, the Company issued 39,488 common stock
options for consulting services valued at $2,500. In November
2003, the Company issued 24,712 common stock options for
consulting services valued at $9,638. In December 2003, the
Company
F-10
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
issued 100,000 common stock options to two former Board members
and 75,000 common stock options to members of its Scientific
Advisory Board. These options were fully exercisable and fully
vested on the date of grant and shall expire in ten years based
on the terms of the options. The fair value of these options,
totaling $68,250, was recorded as a noncash stock issuance cost
by the Company.
In July 2004, the Company issued 10,000 common stock options to
members of it Scientific Advisory Board valued at $33,000. In
November 2004, the Company issued 20,000 common stock options
for consulting services valued at $45,000. In December 2004, the
Company issued 10,000 common stock options for consulting
services valued at $20,200. These options were fully exercisable
and fully vested on the date of grant and shall expire in ten
years based on the terms of the options. The fair value of these
options was recorded as a noncash stock issuance cost by the
Company.
Series A, B and C Convertible Preferred
Stock In January 2001, the Company completed an
8 for 1 stock split of its outstanding common stock and
Series A preferred stock. In November 2001, the Company
completed a 2 for 1 stock split for the Series B preferred
stock and warrants. In October 2003, the Company completed a 1
for 1.266199 reverse stock split of all its common stock. All
share numbers and per share dollar values in the accompanying
financial statements and footnotes have been restated for all
periods presented to reflect the stock splits.
From March 1999 to January 2000, the Company sold
3,803,507 shares of Series A convertible preferred
stock (Series A) for $198,006 ($178,006 in cash
and $20,000 in goods and services), net of issuance costs. From
March 2001 to May 2002, the Company sold 2,743,121 shares
of Series B convertible preferred stock
(Series B) for $1,254,672 in cash, net of
issuance costs. During October 2003, the Company sold
2,367,114 shares of Series C convertible preferred
stock (Series C) for $1,004,486, net of
issuance costs. In addition, in connection with the
Series C financing, the Company issued an option to
purchasers of the Series C to buy an additional
15,304,804 shares of the Companys common stock for
$0.4647 per share or $7,112,142. In connection with the
Series C financing, 289,482 additional shares of
Series B stock were issued to the Series B investors
as a result of anti-dilution provisions.
Upon closing the Series C investment, the Series A and
Series B were all converted to common stock. The
liquidation preference of the Series C is $0.4647 per
share and is payable in preference to the common stock.
Following this distribution, upon liquidation, any remaining
assets of the Company shall be distributed ratably to holders of
the common stock. Upon closing the Companys January 2004
private placement, the Series C stock converted to common
stock.
Warrants In November and December of 2001,
the Company granted warrants to
purchase 252,721 shares of common stock at an exercise
price of $0.4748 per share to purchasers of the
Series B. From January to May 2002, the Company granted
warrants to purchase 109,248 shares of common stock at
an exercise price of $0.4748 per share to purchasers of the
Series B. These warrants are exercisable until
February 15, 2005. In June 2002, the Company granted, to
outside parties for services, warrants to
purchase 67,129 shares of common stock at an exercise
price of $0.13 per share. These warrants were fully
exercisable and fully vested on the date of grant and shall
expire in ten years based on the terms of the warrants. The fair
value of these warrants, totaling $8,500, was recorded as a
non-cash stock issuance cost by the Company.
In connection with the notes issued in 2002 and 2003 (see
Note 4), the Company granted warrants to
purchase 867,419 shares of common stock at an exercise
price of $0.4496 per share. These warrants are exercisable
until October 20, 2007. In October 2003, in conjunction
with the issuance of its Series C convertible preferred
stock, the Company granted warrants to
purchase 2,367,114 shares of common stock to
purchasers of the Series C at an exercise price of
$0.7667 per share. These warrants are exercisable until
October 15, 2008.
F-11
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
In connection with the January 2004 private placement, the
Company issued warrants (the Callable Warrants) to
purchase 8,094,829 shares of common stock at an
exercise price of $1.75 per share, as amended. These
warrants are exercisable until January 28, 2009 and are
callable by the Company under certain conditions. In connection
with the October 2004 private placement, the Company issued
warrants to purchase 2,609,542 shares of common stock
at an exercise price of $2.25 per share. These warrants are
exercisable until October 12, 2009. In December the Company
called the first tranche of the Callable Warrants. Holders of
the Callable Warrants exercised warrants to
purchase 1,571,682 shares of common stock at
$1.75 per share, or approximately $2.7 million in net
proceeds.
The Companys 2004 Stock Plan (the Plan) and
2001 Stock Plan, as amended, provide for the granting of
non-statutory or incentive stock options to acquire shares of
the Companys common stock to employees of the Company. The
Plan is administered by the Board of Directors and permits the
issuance of options for the purchase of up to
10,000,000 shares, as amended, of the Companys common
stock at exercises prices of not less than the fair market value
of the underlying shares on the date of grant. Options granted
under the Plan generally vest over a four-year period and expire
up to a maximum of 10 years from the date of grant.
The following table summarizes stock option activity for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Shares | |
|
Weighted | |
|
|
Underlying | |
|
Average Option | |
|
|
Stock Options | |
|
Price per Share | |
|
|
| |
|
| |
Outstanding, January 1, 2002
|
|
|
|
|
|
|
|
|
Granted
|
|
|
60,573 |
|
|
$ |
0.06 |
|
Canceled
|
|
|
(10,327 |
) |
|
$ |
0.06 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2002
|
|
|
50,246 |
|
|
$ |
0.06 |
|
Granted
|
|
|
6,603,426 |
|
|
$ |
0.38 |
|
Exercised
|
|
|
(256,410 |
) |
|
$ |
0.39 |
|
Canceled
|
|
|
(4,695 |
) |
|
$ |
0.06 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2003
|
|
|
6,392,567 |
|
|
$ |
0.38 |
|
Granted
|
|
|
2,814,240 |
|
|
$ |
2.01 |
|
Exercised
|
|
|
(506,410 |
) |
|
$ |
0.39 |
|
|
|
|
|
|
|
|
Outstanding, December 31, 2004
|
|
|
8,700,397 |
|
|
$ |
0.91 |
|
|
|
|
|
|
|
|
The following table summarizes information for outstanding and
exercisable options as of December 31, 2004:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding | |
|
Options Exercisable | |
|
|
| |
|
| |
|
|
|
|
Weighted | |
|
|
|
|
|
|
|
|
Average | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Remaining | |
|
Average | |
|
Number | |
|
Average | |
|
|
Number | |
|
Contractual | |
|
Exercise | |
|
Vested and | |
|
Exercise | |
Exercise Price |
|
Outstanding | |
|
Life in Years | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$0.06
|
|
|
164,015 |
|
|
|
5.5 |
|
|
$ |
0.06 |
|
|
|
153,198 |
|
|
$ |
0.06 |
|
$0.39 $0.43
|
|
|
6,216,382 |
|
|
|
8.1 |
|
|
$ |
0.40 |
|
|
|
2,194,834 |
|
|
$ |
0.40 |
|
$1.25
|
|
|
150,000 |
|
|
|
9.1 |
|
|
$ |
1.25 |
|
|
|
|
|
|
|
|
|
$2.02 $2.25
|
|
|
1,687,000 |
|
|
|
9.8 |
|
|
$ |
2.04 |
|
|
|
430,000 |
|
|
$ |
2.04 |
|
$3.30 $4.10
|
|
|
483,000 |
|
|
|
9.4 |
|
|
$ |
3.81 |
|
|
|
68,332 |
|
|
$ |
3.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,700,397 |
|
|
|
8.5 |
|
|
$ |
0.91 |
|
|
|
2,846,364 |
|
|
$ |
0.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-12
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
Income taxes are recorded in accordance with
SFAS No. 109, Accounting for Income Taxes. This
statement requires the recognition of deferred tax assets and
liabilities to reflect the future tax consequences of events
that have been recognized in the Companys financial
statements or tax returns. Measurement of the deferred items is
based on enacted tax laws. In the event the future consequences
of differences between financial reporting bases and tax bases
of the Companys assets and liabilities result in a
deferred tax asset, SFAS No. 109 requires an
evaluation of the probability of being able to realize the
future benefits indicated by such assets. A valuation allowance
related to a deferred tax asset is recorded when it is more
likely than not that some portion or the entire deferred tax
asset will not be realized. The Company had combined federal and
state deferred tax assets of approximately $5,500,000 at
December 31, 2004 and $1,400,000 at December 31, 2003,
consisting primarily of net operating loss carryforwards. The
Company has recorded a full valuation allowance for all net
deferred tax assets generated to date. The deferred tax assets
and valuation allowance increased approximately $4,100,000 in
2004. The federal and state net operating losses total
approximately $12,200,000, and begin to expire in 2018 and 2008,
respectively.
|
|
9. |
Commitments and Contingencies |
Operating Leases On May 20, 2003, the
Company signed a two-year lease for 5,728 square feet of
office and lab space in a building located at 11588 Sorrento
Valley Road, San Diego, California, commencing on
June 1, 2003. On October 28, 2004, the Company signed
an 18-month lease for an additional 5,060 square feet of
office and lab space in the same building, commencing on
January 1, 2005. Additionally, the Company leases certain
office equipment under operating leases. Rent expense totaled
$147,638 and $123,110 for the years ended December 31, 2004
and 2003, respectively.
Future minimum payments, by year and in the aggregate, required
under the Companys non-cancelable operating lease
obligations consist of the following:
|
|
|
|
|
|
Year Ending December 31
|
|
|
|
|
|
2005
|
|
$ |
159,134 |
|
|
2006
|
|
|
47,364 |
|
|
|
|
|
|
|
|
206,498 |
|
|
|
|
|
Material Agreement In February 2005, we
entered into a Commercial Supply Agreement with Avid
Bioservices, Inc. (Avid). Avid will manufacture
under current good manufacturing practices our first recombinant
human enzyme on a non-exclusive basis over the next two years.
This enzyme will be used in
Cumulasetm
and Enhanze
SCtm,
our first two product candidates, as well as in other products
currently in development. Avid will produce up to seven batches
per year of the enzyme under the terms of the Agreement. The
enzyme is used in Enhanze SC, which may require a pre-approval
inspection (PAI). If Avid fails this PAI, it could have a
material adverse effect on our business. We have not established
and may not be able to establish arrangements with additional
manufacturers for these ingredients or products should the
existing supplies become unavailable or in the event that our
sole contract manufacturer is unable to adequately perform its
responsibilities. Difficulties in our relationship with our
manufacturer or delays or interruptions in such
manufacturers supply of its requirements could limit or
stop our ability to provide sufficient quantities of our
products, on a timely basis, for clinical trials and, if our
products are approved, could limit or stop commercial sales,
which would have a material adverse effect on our business and
financial condition.
Legal Contingencies In the ordinary course of
business, we may face various claims brought by third parties,
including claims relating to the safety or efficacy of our
products. Any of these claims could subject us to costly
litigation and, while we generally believe that we have adequate
insurance to cover many different
F-13
Halozyme Therapeutics, Inc.
Notes to Consolidated Financial
Statements (Continued)
types of liabilities, our insurance carriers may deny coverage
or our policy limits may be inadequate to fully satisfy any
damage awards or settlements. If this were to happen, the
payment of any such awards could have a material adverse effect
on our operations and financial position. Additionally, any such
claims, whether or not successful, could damage our reputation
and business.
F-14