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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-Q
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(MARK ONE)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2004
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM __________TO
__________.
COMMISSION FILE NUMBER: 000-1029142
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DYNAVAX TECHNOLOGIES CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 33-0728374
(State or Other Jurisdiction of (IRS Employer Identification No.)
Incorporation or Organization
717 POTTER STREET, SUITE 100
BERKELEY, CA 94710-2722
(Address Of The Registrant's Principal Executive Offices)
Registrant's Telephone Number, Including Area Code: (510) 848-5100
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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 [ X ] No [ ]
Indicate by check mark whether the registrant is an accelerated filer (as
defined in Rule 12b-2 of the Act). Yes [ ] No [X]
The number of shares of the Registrant's Common Stock outstanding as of
April 30, 2004 was 24,608,001.
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INDEX
DYNAVAX TECHNOLOGIES CORPORATION
Page No.
--------
PART I FINANCIAL STATEMENTS
Item 1. Condensed Consolidated Financial Statements (Unaudited)............................ 3
Condensed Consolidated Balance Sheets as of March 31, 2004 and December 31, 2003
Condensed Consolidated Statements of Operations for the Three Months Ended
March 31, 2004 and 2003
Condensed Consolidated Statements of Cash Flows for the Three Months Ended
March 31, 2004 and 2003
Notes to Condensed Consolidated Financial Statements
Item 2. Management's Discussion and Analysis of Financial Condition and Results of
Operations......................................................................... 11
Item 3. Quantitative and Qualitative Disclosures about Market Risk......................... 24
Item 4. Controls and Procedures............................................................ 24
PART II OTHER INFORMATION
Item 1. Legal Proceedings.................................................................. 25
Item 2. Changes in Securities and Use of Proceeds and Issuer Purchases of Equity
Securities......................................................................... 25
Item 3. Defaults upon Senior Securities.................................................... 25
Item 4. Submission of Matters to a Vote of Security Holders................................ 25
Item 5. Other Information.................................................................. 25
Item 6. Exhibits and Reports on Form 8-K................................................... 25
SIGNATURES....................................................................................... 26
PART I. FINANCIAL STATEMENTS
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
MARCH 31, DECEMBER 31,
2004 2003
--------- ---------
(Unaudited) (Note 1)
ASSETS
Current assets:
Cash and cash equivalents $ 75,012 $ 23,468
Restricted cash 77 --
Marketable securities 3,556 5,629
Accounts receivable 2,780 220
Prepaid expenses and other current assets 1,191 1,422
--------- ---------
Total current assets 82,616 30,739
Property and equipment, net 734 828
Other assets 435 18
--------- ---------
Total assets $ 83,785 $ 31,585
========= =========
LIABILITIES, MINORITY INTEREST, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS'
EQUITY (NET CAPITAL DEFICIENCY)
Current liabilities:
Accounts payable $ 2,036 $ 1,410
Accrued liabilities 3,579 2,989
Current portion of deferred revenue 1,750 750
--------- ---------
Total current liabilities 7,365 5,149
Noncurrent portion of deferred revenue 6,750 --
Commitments and contingencies
Minority interest in Dynavax Asia -- 14,733
Convertible preferred stock -- 83,635
Stockholders' equity (net capital deficiency):
Preferred stock: $0.001 par value; 5,000 shares authorized and no shares
issued and outstanding at March 31, 2004 or December 31, 2003 -- --
Common stock: $0.001 par value; 100,000 and 28,333 shares authorized at March
31, 2004 and December 31, 2003, respectively; 24,608 and 1,884 shares
issued and outstanding at March 31, 2004 and December 31, 2003, respectively 25 2
Additional paid-in capital 158,441 12,762
Deferred stock compensation (4,953) (4,677)
Notes receivable from stockholders (612) (654)
Accumulated deficit (83,231) (79,365)
--------- ---------
Total stockholders' equity (net capital deficiency) 69,670 (71,932)
--------- ---------
Total liabilities, minority interest, convertible preferred stock, and
stockholders' equity (net capital deficiency) $ 83,785 $ 31,585
========= =========
See accompanying notes.
DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE AMOUNTS)
(UNAUDITED)
THREE MONTHS ENDED MARCH 31,
----------------------------
2004 2003
-------- -------
Revenues:
Collaboration revenue $ 2,744 $ --
Grant revenue 461 --
-------- -------
Total revenues 3,205 --
Operating expenses:
Research and development 5,801 3,810
General and administrative 1,389 1,039
-------- -------
Total operating expenses 7,190 4,849
Loss from operations (3,985) (4,849)
Interest income, net 119 131
-------- -------
Net loss $ (3,866) $(4,718)
======== =======
Basic and diluted net loss per share $ (0.36) $ (2.68)
======== =======
Shares used to compute basic and diluted net loss per share 10,847 1,759
======== =======
See accompanying notes.
DYNAVAX TECHNOLOGIES CORPORATION
CONDENSED CONSOLIDATED STATEMENTS CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED MARCH 31,
----------------------------
2004 2003
-------- -------
OPERATING ACTIVITIES
Net loss $ (3,866) $(4,718)
Adjustments to reconcile net loss to net cash used in operating
activities:
Depreciation and amortization 119 173
Loss on disposal of property and equipment 17 --
Accretion and amortization on investments 54 180
Interest accrued on notes receivable from stockholders (10) (10)
Stock-based compensation expense 626 324
Changes in operating assets and liabilities:
Accounts receivable (2,560) --
Prepaid expenses and other current assets 77 242
Other assets (417) --
Accounts payable 626 (866)
Accrued liabilities 590 (316)
Deferred revenue 7,750 --
-------- -------
Net cash provided by (used in) operating activities 3,006 (4,991)
INVESTING ACTIVITIES
Purchase of marketable securities -- (519)
Maturities and sale of marketable securities 2,019 7,000
Purchases of property and equipment (42) (22)
-------- -------
Net cash provided by investing activities 1,977 6,459
FINANCING ACTIVITIES
Proceeds from issuance of common stock, net of issuance costs 46,432 --
Repurchase of common stock -- (36)
Repayment of notes receivable from stockholders 52 35
Restricted cash 77 --
-------- -------
Net cash provided by (used in) financing activities 46,561 (1)
Net increase in cash and cash equivalents 51,544 1,467
Cash and cash equivalents at beginning of the period 23,468 5,171
-------- -------
Cash and cash equivalents at end of the period $ 75,012 $ 6,638
======== =======
See accompanying notes.
5
DYNAVAX TECHNOLOGIES CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2004
(UNAUDITED)
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The terms "Dynavax," the "Company," "we" and "us" as used in this report refer
to Dynavax Technologies Corporation. The accompanying condensed consolidated
unaudited balance sheet as of March 31, 2004 and condensed consolidated
statements of operations for the three month periods ended March 31, 2004 and
2003 have been prepared in accordance with generally accepted accounting
principles for interim financial information and with the instructions to Form
10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of
the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of the management
of the Company, all adjustments (consisting only of normal recurring accruals)
considered necessary for a fair presentation have been included. Operating
results for the three month period ended March 31, 2004 are not necessarily
indicative of the results that may be expected for the year ended December 31,
2004 or any other period. The condensed consolidated balance sheet at December
31, 2003 has been derived from the audited consolidated financial statements at
that date but does not include all of the information and footnotes required by
generally accepted accounting principles for complete financial statements.
These unaudited condensed financial statements and the notes accompanying them
should be read in conjunction with the Company's Annual Report on Form 10-K for
the year ended December 31, 2003.
DYNAVAX ASIA
In October 2003, the Company formed Dynavax Asia Pte. Ltd., or Dynavax Asia, a
100% owned Singapore subsidiary, which will focus on the Company's clinical and
preclinical hepatitis B programs. Also in October 2003, the Company completed a
sale of 15,200,000 ordinary shares in Dynavax Asia, which reduced the Company's
ownership in Dynavax Asia from 100% to 50%. The Company recorded the sale of the
ordinary shares as a minority interest liability in the consolidated financial
statements. As a result of the Company's initial public offering in February
2004, ordinary shares in Dynavax Asia were converted into 2,111,111 shares of
common stock in the Company, which was accounted for as a capital transaction,
and Dynavax Asia became a wholly owned subsidiary. The Company will support the
development activities of Dynavax Asia through its U.S. personnel and through
limited hiring in Singapore.
PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of Dynavax and
Dynavax Asia, its wholly-owned subsidiary. All significant intercompany accounts
and transaction have been eliminated.
CRITICAL ACCOUNTING POLICIES
The Company believes that there have been no significant changes in its critical
accounting policies during the three months ended March 31, 2004 as compared
with those previously disclosed in its Annual Report on Form 10-K for the year
ended December 31, 2003 filed with the SEC on March 30, 2004.
RESTRICTED CASH
As of March 31, 2004, the Company held $76,954 in a certificate of deposit as
collateral on an irrevocable standby letter of credit as a security deposit for
its new operating lease, which the Company entered into in January 2004.
NET LOSS PER SHARE
Basic earnings per share is computed based on the number of weighted average
shares outstanding. The calculation of diluted net loss per share excludes
shares of potential common stock, consisting of stock options and warrants,
because their effect is anti-dilutive
6
THREE MONTHS ENDED MARCH 31,
----------------------------
2004 2003
-------- -------
(IN THOUSANDS, EXCEPT PER SHARE
AMOUNTS)
Numerator:
Net loss $ (3,866) $(4,718)
-------- -------
Denominator:
Weighted-average common shares outstanding 10,874 1,840
Less: Weighted-average unvested common shares subject to repurchase (27) (81)
-------- -------
Denominator for basic and diluted net loss per share 10,847 1,759
======== =======
Basic and diluted net loss per share $ (0.36) $ (2.68)
======== =======
REVENUE RECOGNITION
The Company recognizes collaboration, upfront and other revenue based on the
terms specified in the agreements, generally as work is performed or
approximating the straight-line basis over the period of the collaboration. Any
amounts received in advance of performance are recorded as deferred revenue.
Revenue from milestones with substantive performance risk is recognized upon
achievement of the milestone. All revenues recognized to date under these
collaborations and milestones are nonrefundable.
Revenues related to government grants are recognized as the related research
expenses are incurred. Any amounts received in advance of performance are
recorded as deferred revenue until earned.
Payments by collaborators for the option to license technology or product rights
in the future are deferred when received. When an option is exercised, revenue
is recognized on a straight-line basis over the term of the resulting license
agreement. In the event that an option expires without exercise, the payment is
recognized in full at the expiration of the agreement.
STOCK-BASED COMPENSATION
The Company has adopted the pro forma disclosure requirements of Statement of
Financial Accounting Standards (SFAS) No. 123, Accounting for Stock-Based
Compensation ("SFAS 123") as amended by SFAS No. 148, Accounting for Stock-Based
Compensation - Transition and Disclosure ("SFAS 148"). As permitted, the Company
continues to recognize employee stock compensation under the intrinsic value
method of accounting as prescribed by Accounting Principles Board Opinion No. 25
("APB 25") and its interpretations. Under APB 25, compensation expense is based
on the difference, if any, on the date of grant, between the deemed fair value
of the Company's common stock and the option exercise price, and is amortized
over the respective vesting period of the options using the straight-line
method. The pro forma effects of applying SFAS 123, as amended by SFAS 148, on
the Company's net loss had compensation cost for options granted to employees
been determined based on the fair value at grant date as prescribed by SFAS 123,
would be as follows (in thousands, except per share amounts):
THREE MONTHS ENDED MARCH 31,
----------------------------
2004 2003
------- -------
Net loss:
As reported $(3,866) $(4,718)
Add:
Stock-based employee compensation expense
included in net loss 626 324
7
Less:
Stock-based employee compensation expense
determined under the fair value based method (762) (415)
------- -------
Pro forma $(4,002) $(4,809)
======= =======
Net loss per share
Basic and diluted, as reported $ (0.36) $ (2.68)
======= =======
Basic and diluted, pro forma $ (0.37) $ (2.73)
======= =======
Such pro forma disclosure may not be representative of future stock-based
compensation expense because such options vest over several years and additional
grants may be made each year.
The estimate fair value of each option grant to employees is estimated on
the date of grant using the Black-Scholes option pricing method with the
following weighted average assumptions:
THREE MONTHS ENDED MARCH 31,
2004 2003
---- ----
Expected dividend yield 0% 0%
Risk-free interest rate 2.3% to 2.8% 2.6%
Expected life (in years) 4 4
Volatility 1.0 1.0
The weighted-average estimated fair value per share of employee stock options
granted during the first quarter of 2004 and 2003 was $6.11 and $4.26,
respectively.
2. COMMITMENTS AND CONTINGENCIES
OPERATING LEASE
The Company leases its facilities under two operating leases that expire
in May 2008 and March 2014. In January 2004, the Company amended its operating
lease for one of its facilities to include an option to terminate early its
remaining liability under the terms of the original lease. Under the terms of
the amendment, the Company would pay a termination fee of $300,000 if it chooses
to exercise the termination option; however, the Company has not exercised that
option as of March 31, 2004. Under one of its leases, the Company has the option
through May 2004 to expand the amount of office and laboratory space it
occupies. This lease can be terminated at no cost to the Company in March 2009
but extends automatically until March 2014 if the Company chooses not to
terminate the lease.
Future minimum payments under the non-cancelable portion of the operating
leases at March 31, 2004, assuming that the Company does not exercise its option
to terminate early one of its leases, are as follows (in thousands):
Year ending December 31,
2004 $ 571
2005 770
2006 779
2007 789
2008 and beyond 592
------
$3,501
======
8
3. COLLABORATIVE RESEARCH, DEVELOPMENT, AND LICENSE AGREEMENTS
UNIVERSITY OF CALIFORNIA
The Company entered into a series of exclusive license agreements with the
Regents of the University of California (UC) in March 1997 and October 1998.
These agreements provide the Company with certain technology and related patent
rights and materials. Under the terms of the agreements, the Company pays annual
license or maintenance fees and will be required to pay milestones and royalties
on net sales of products originating from the licensed technologies. The
agreements will expire on either the expiration date of the last-to-expire
patent licensed under the agreements or the date upon which the last patent
application licensed under the agreements is abandoned. The Company incurred
license and milestone fees of $20,000 and $20,000 and patent expenses of
approximately $42,000 and $34,000 in the three month periods ended March 31,
2004, and 2003, respectively, in connection with these license agreements, all
of which was recorded as research and development expense. Included in accounts
payable at March 31, 2004 and December 31, 2003, was approximately $17,600 and
$13,400, respectively, related to patent expenses. The Company incurred a
$375,000 one-time charge to UC due upon the closing of the Company's initial
public offering as partial consideration for the technology licenses. The
Company recorded this charge as research and development expense in the period
ended March 31, 2004. Also as partial consideration for the technology licenses,
the Company incurred a one-time charge of $150,000 to UC related to the $8
million upfront payment from UCB Farchim S.A., which is being amortized over the
development period of the licensed programs, currently estimated to be eight
years.
LICENSE AND DEVELOPMENT AGREEMENT WITH UCB
In February 2004, the Company entered into an agreement with UCB Farchim,
S.A., a subsidiary of UCB, S.A., or UCB, a publicly traded multi-national
company based in Brussels, Belgium, in which the Company licensed the
technology, know-how and preclinical and clinical data related to its AIC and
grass allergy programs to UCB on an exclusive, worldwide basis. UCB was also
granted an option to license the Company's peanut allergy program. According to
terms of the agreement, the Company received an $8 million upfront payment and
may earn up to $40 million in milestone payments based on achieving defined
clinical and regulatory objectives. The Company is amortizing the $8 million
upfront payment from UCB over the development period of the licensed programs,
currently estimated to be eight years. In addition, UCB agreed to fund ongoing
research and development of the licensed programs, as well as costs relating to
regulatory filings and potential launch, sales and marketing. The Company is
accounting for such funding as collaboration revenue, which is generally
recognized in the period in which expenses related to the licensed programs are
incurred. The related expenses are included in research and development expenses
on the statement of operations. If any of the licensed product candidates are
successfully developed and approved for sale, the Company will receive royalties
on sales. The Company has retained an option to co-promote any approved product
in the United States, in which case the Company would recognize revenue from
sales in lieu of receiving royalty payments. UCB may terminate the agreement at
any time on 60 days' advance notice either in its entirety or with respect to
one or more licensed programs, but may not terminate the agreement as to our
ragweed allergy program prior to February 2006 except for safety or efficacy
reasons, in which case it may not terminate the agreement prior to February
2005. Either party may terminate the UCB agreement if a default occurs and is
not cured. Otherwise, the agreement does not terminate until the later to occur
of the date when the last valid issued patent claim covering any of the licensed
programs expires or June 2018. Total revenue recognized during the three month
period ended March 31, 2004, related to the UCB agreement was $2.7 million,
making up 86% of total revenues and 90% of total accounts receivables balances.
4. INITIAL PUBLIC OFFERING
In October 2003, the Board of Directors and Stockholders approved a
one-for three reverse stock split of its outstanding shares of common stock. An
amended and restated certificate of incorporation reflecting the reverse stock
split was filed on February 3, 2004. All common share and per share amounts
contained in the condensed consolidated financial statements have been adjusted
to reflect this stock split.
In February 2004 the Company sold a total of 6,900,000 shares of its
common stock, after adjusting for a one-for-three reverse stock split, in an
underwritten initial public offering, raising net proceeds of approximately
$46.4 million. As a result of the initial public offering, all outstanding
shares of Preferred Stock with a net value of
9
$83.6 million converted to 13,712,128 shares of common stock and the 15,200,000
shares of ordinary stock in Dynavax Asia with a net value of $14.7 million
converted into 2,111,111 shares of common stock making Dynavax Asia a
wholly-owned subsidiary as of that date.
10
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
This Report on Form 10-Q contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 which are subject to the safe harbor created by
those sections. These forward-looking statements include, but are not limited
to: statements about our business strategy, our future research and development,
our preclinical and clinical product development efforts, the timing of the
introduction of our products, the effect of GAAP accounting pronouncements on
our recognition of revenue, uncertainty regarding our future operating results
and our profitability, anticipated sources of funds and all plans, objectives,
expectations and intentions contained in this report that are not historical
facts. We usually use words such as may, will, should, expect, plan, anticipate,
believe, estimate, predict, future, intend, or certain or the negative of these
terms or similar expressions to identify forward-looking statements. Discussions
containing such forward-looking statements may be found throughout the document.
These forward-looking statements involve certain risks and uncertainties that
could cause actual results to differ materially from those in such
forward-looking statements. We disclaim any obligation to update these
forward-looking statements as a result of subsequent events. The business risks
discussed in Item 2 of this Report on Form 10-Q, among other things, should be
considered in evaluating our prospects and future financial performance.
The following discussion and analysis is intended to provide an investor
with a narrative of our financial results and an evaluation of our financial
condition and results of operations. The discussion should be read in
conjunction with our consolidated financial statements and notes thereto.
OVERVIEW
We discover, develop and intend to commercialize innovative products to
treat and prevent allergies, infectious diseases and chronic inflammatory
diseases. Our clinical development programs are based on immunostimulatory
sequences, or ISS, which are short DNA sequences that enhance the ability of the
immune system to fight disease and control chronic inflammation. Our most
advanced clinical programs include AIC, an immunotherapy product candidate for
treatment of ragweed allergy that has completed Phase II trials, our hepatitis B
vaccine, which is nearing completion of two Phase II trials, and an inhaled
therapeutic product candidate for treatment of asthma, which is currently in a
pilot Phase II trial. Based on results from Phase II trials, we plan to initiate
Phase IIb and Phase III trials for AIC and Phase III trials for our hepatitis B
vaccine. We intend to commercialize our hepatitis B vaccine only outside the
U.S. In addition, we have a cancer therapeutic product in Phase I trials and
preclinical programs targeting additional allergies using our ISS technology. We
have other preclinical programs focused on chronic inflammation, antiviral
therapies and improved, next-generation vaccines using ISS and other
technologies.
CRITICAL ACCOUNTING POLICIES AND THE USE OF ESTIMATES
The Company believes that there have been no significant changes in its critical
accounting policies during the three months ended March 31, 2004 as compared
with those previously disclosed in its Annual Report on Form 10-K for the year
ended December 31, 2003 filed with the SEC on March 30, 2004.
11
RESULTS OF OPERATIONS
Comparison of Three Months Ended March 31, 2004 and 2003
THREE MONTHS ENDED
MARCH 31, INCREASE/DECREASE
RESULTS OF OPERATIONS 2004 2003 $ %
- --------------------- ------ ------ ------- -------
Revenues:
Collaboration revenue $2,744 $ -- $ 2,744 n/a
Grant revenue 461 -- 461 n/a
------ ------ ------- ----
Total revenues 3,205 -- 3,205 n/a
Research and development expenses 5,801 3,810 1,991 52.3%
General and administrative expenses 1,389 1,039 350 33.7
------ ------ ------- ----
Total operating expenses 7,190 4,849 2,341 48.3
Interest income, net 119 131 (12) (9.2)
Revenues for the period ended March 31, 2004, were approximately $3.2
million. We recorded no revenue for the period ended March 31, 2003. Revenue for
the period ended March 31, 2004, resulted from $2.7 million in reimbursed
research and development expenses and amortization of an $8.0 million upfront
payment pursuant to a collaborative agreement with UCB, as well as revenue of
$0.5 million from government grants for biodefense programs. We expect revenues
from our collaboration with UCB and from government grants for biodefense
programs to continue through 2004 as reimbursement for our expenses associated
with those programs.
Research and development expenses were approximately $5.8 million for the
period ended March 31, 2004, an increase of 52.3% from approximately $3.8
million for the period ended March 31, 2003. This increase was primarily the
result of increased clinical trial activity in the our ragweed allergy,
hepatitis B vaccine and asthma programs, as well as preclinical work associated
with government grants for biodefense programs, being conducted during the
period ended March 31, 2004. Non-cash stock-based compensation expense included
in research and development expense was approximately $0.4 million and $0.2
million for the periods ended March 31, 2004, and 2003, respectively. We expect
research and development expenses in future periods generally to be consistent
with or gradually up from levels experienced in the period ended March 31, 2004,
as our clinical and preclinical programs progress.
General and administrative expenses were approximately $1.4 million for
the period ended March 31, 2004, an increase of 33.7% as compared to
approximately $1.0 million in general and administrative expenses for the period
ended March 31, 2003. This increase reflects higher compensation and benefits
during the period ended March 31, 2004, associated primarily with the expanding
of our management team and expenditures for consulting and professional
services. Non-cash stock-based compensation expense included in general and
administrative expense was approximately $0.2 million and $0.1 million for the
periods ended March 31, 2004, and 2003, respectively. We expect general and
administrative expenses to grow beyond levels experienced in the period ended
March 31, 2004, as a result of our expanding organization, incurring costs of
operating as a public company, and increasing our lease and related obligations,
Interest income, net, was approximately $119,000 for the period ended
March 31, 2004, a decrease of 9.2% as compared to approximately $131,000 in
interest income, net, for the period ended March 31, 2003. The decrease was
primarily due to lower yields on invested cash and marketable securities during
the period ended March 31, 2004.
12
LIQUIDITY AND CAPITAL RESOURCES
We have financed our operations from inception primarily through sales of
shares of common stock, convertible preferred stock, and ordinary shares in a
subsidiary, which have yielded a total of approximately $144.8 million in net
cash proceeds and, to a lesser extent, through amounts received under
collaborative agreements and government grants for biodefense programs. As of
March 31, 2004, we had approximately $78.6 million in cash, cash equivalents and
marketable securities. Our funds are currently invested in highly liquid,
institutional money market funds and in investment-grade corporate and
government obligations.
Our operating activities generated cash of approximately $3.0 million
during the period ended March 31, 2004, compared to cash used in operating
activities of approximately $5.0 million during the period ended March 31, 2003.
This increase of approximately $8.0 million was due primarily to an $8.0 million
upfront payment made to us by UCB and a narrower loss from operations.
Our investing activities provided cash of approximately $2.0 million
during the period ended March 31, 2004, compared to approximately $6.5 million
during the period ended March 31, 2003. Cash provided by investing activities
consisted primarily of maturities and sales of investments of approximately $2.0
million and $7.0 million during the periods ended March 31, 2004, and 2003,
respectively.
Our financing activities provided cash of approximately $46.6 million,
primarily from the issuance of 6,900,000 shares of common stock in our initial
public offering in February 2004 and repayment of notes receivable from
stockholders during the period ended March 31, 2004. Virtually no net cash from
financing activities was generated during the period ended March 31, 2003.
LONG-TERM DEBT AND OPERATING LEASES
We have no long-term debt. As of March 31, 2004, and assuming that we do
not exercise our option to terminate early one of our leases, we had contractual
obligations related to non-cancelable portion of the operating leases as follows
(in thousands):
Payments Due by Period
------------------------------------------------------------
Less
than 1 1-3 4-5 After
Total year years years 5 years
------- ------ ------- ------- -------
Operating leases $ 3,501 $ 571 $ 1,549 $ 1,381 $ -
======= ===== ======= ======= ===
The Company leases its facilities under two operating leases that expire
in May 2008 and March 2014. In January 2004, the Company amended its operating
lease for one of its facilities to include an option to terminate early its
remaining liability under the terms of the original lease. Under the terms of
the amendment, the Company would pay a termination fee of $300,000 if it chooses
to exercise the termination option; however, the Company has not exercised that
option as of March 31, 2004. Under one of its leases, the Company has the option
through May 2004 to expand the amount of office and laboratory space it
occupies. This lease can be terminated at no cost to the Company in March 2009
but extends automatically until March 2014 if the Company chooses not to
terminate the lease.
We believe our existing cash, cash equivalents and marketable securities,
together with the payments due to us under the terms of our collaboration
agreement with UCB, will be sufficient to meet our anticipated cash requirements
through 2006. Because of the significant time it will take for any of our
product candidates to complete the clinical trials process, be approved by
regulatory authorities and successfully commercialized, we may require
substantial additional capital resources. We may raise additional funds through
public or private equity offerings, debt financings, capital lease transactions,
corporate collaborations or other means. We may attempt to raise additional
capital due to favorable market conditions or strategic considerations even if
we have sufficient funds for planned operations. To the extent that we raise
additional funds by issuing equity securities, our stockholders will experience
dilution, and debt financings, if available, may involve restrictive covenants
or may otherwise constrain our financial flexibility. To the extent that we
raise additional funds through collaborative
13
arrangements, it may be necessary to relinquish some rights to our technologies
or grant licenses on terms that are not favorable to us. In addition, payments
made by potential collaborators, government agencies and other licensors
generally will depend upon our achievement of negotiated development and
regulatory milestones. Failure to achieve these milestones may significantly
harm our future capital position.
Additional financing may not be available on acceptable terms, if at all.
Capital may become difficult or impossible to obtain due to poor market or other
conditions that are outside of our control. If at any time sufficient capital is
not available, either through existing capital resources or through raising
additional funds, we may be required to delay, reduce the scope of, eliminate or
divest one or more of our research, preclinical or clinical programs or
discontinue our business.
ADDITIONAL FACTORS THAT MAY AFFECT FUTURE RESULTS
Various discussions in this Quarterly Report on Form 10-Q contain
forward-looking statements concerning our future products, expenses, revenue,
liquidity and cash needs, as well as our plans and strategies. These
forward-looking statements are based on current expectations and we assume no
obligation to update this information. Numerous factors could cause our actual
results to differ significantly from the results described in these
forward-looking statements, including the following risk factors.
WE HAVE INCURRED SUBSTANTIAL LOSSES SINCE INCEPTION AND DO NOT HAVE ANY
COMMERCIAL PRODUCTS THAT GENERATE REVENUE.
We have experienced significant operating losses in each year since our
inception in August 1996. Currently, our revenue results from payments made
under a collaboration agreement and payments received under government grants
for biodefense programs. The collaboration agreement is subject to termination
under specified circumstances. The grants are subject to annual review based on
the achievement of milestones and other factors and will terminate in 2006 at
the latest. Our accumulated deficit was approximately $83.2 million as of March
31, 2004, and we anticipate that we will incur substantial additional operating
losses for the foreseeable future. These losses have been, and will continue to
be, principally the result of the various costs associated with our research and
development activities. We expect our losses to increase primarily as a
consequence of our continuing product development efforts.
We do not have any products that generate revenue. We began Phase IIb
trials for AIC, an immunotherapy for ragweed allergy, and expect to begin Phase
IIb trials for our hepatitis B vaccine in 2004. Our product candidates may never
be commercialized, and we may never generate product-related revenue. Our
ability to generate revenue depends upon:
- - demonstrating in clinical trials that our product candidates are safe
and effective, in particular, in the planned Phase III trials for AIC
and our hepatitis B vaccine;
- - obtaining regulatory approvals for our product candidates in the U.S.
and international markets;
- - entering into collaborative relationships on commercially reasonable
terms for the development, manufacturing, sales and marketing of our
product candidates, and then successfully managing these relationships;
and
- - commercial acceptance of our products, in particular AIC and our
hepatitis B vaccine. If we are unable to generate revenues or achieve
profitability, we may be required to significantly reduce or discontinue
our operations or raise additional capital under adverse circumstances.
IF WE ARE UNABLE TO SECURE ADDITIONAL FUNDING, WE WILL HAVE TO REDUCE OR
DISCONTINUE OPERATIONS.
We believe our existing capital resources, will be sufficient to meet our
anticipated cash requirements through 2006. We do not believe that we will have
product revenue until 2007, at the earliest. Because of the significant time and
resources it will take to develop our product candidates, potentially
commercialize them and
14
generate revenue, we may require substantial additional capital resources in
order to continue our operations, and any such funding may not cover our costs
of operations.
We may be unable to obtain additional capital from financing sources or
from agreements with collaborators on acceptable terms, or at all. If at any
time sufficient capital is not available, we may be required to delay, reduce
the scope of, eliminate or divest one or more of our research, preclinical or
clinical programs or discontinue our operations.
ALL OF OUR PRODUCT CANDIDATES ARE UNPROVEN, AND OUR SUCCESS DEPENDS ON OUR
PRODUCT CANDIDATES BEING APPROVED THROUGH UNCERTAIN AND TIME-CONSUMING
REGULATORY PROCESSES. FAILURE TO PROVE OUR PRODUCTS SAFE AND EFFECTIVE IN
CLINICAL TRIALS AND OBTAIN REGULATORY APPROVALS COULD REQUIRE US TO DISCONTINUE
OPERATIONS.
None of our product candidates has been proven safe and effective in
clinical trials or approved for sale in the U.S. or any foreign market. Any
product candidate we develop is subject to extensive regulation by Federal,
state and local governmental authorities in the U.S., including the Food and
Drug Administration, or FDA, and by foreign regulatory agencies. Our success is
primarily dependent on our ability to obtain regulatory approval for AIC, our
ragweed allergy product candidate, and our hepatitis B vaccine product
candidate. We intend to commercialize our hepatitis B vaccine only outside the
U.S., which will require us to seek approval from foreign regulatory agencies.
Approval processes in the U.S. and in other countries are uncertain, take many
years and require the expenditure of substantial resources. Product development
failure can occur at any stage of clinical trials and as a result of many
factors, many of which are not under our control.
Currently, only three of our product candidates have advanced to Phase II
clinical trials: AIC, our hepatitis B vaccine and our inhaled therapeutic for
treatment of asthma. We have only limited clinical data for these product
candidates, some of which may not be supportive of ultimate regulatory approval.
In particular, in one of our Phase II trials for AIC, which was conducted in
Canada in 2001 and 2002, there was no impact on clinical symptom scores or
medication use in the first year of the two-year trial. We will need to
demonstrate in Phase III clinical trials that each product candidate is safe and
effective before we can obtain necessary approvals from the FDA and foreign
regulatory agencies. We initiated a two-year, multi-site Phase IIb trial in the
first quarter of 2004 in the U.S. for AIC. We expect to begin planning later in
2004 a confirmatory Phase III trial for AIC, which will focus on the 2005
ragweed season. We also expect to begin planning in 2004 Phase III trials for
our hepatitis B vaccine outside the U.S. The FDA or foreign regulatory agencies
may require us to conduct additional clinical trials prior to approval in their
jurisdictions.
Many new drug candidates, including many drug candidates that have
completed Phase III clinical trials, have shown promising results in early
clinical trials and subsequently failed to establish sufficient safety and
efficacy to obtain regulatory approval. Despite the time and money expended,
regulatory approvals are never guaranteed. Failure to complete clinical trials
and prove that our products are safe and effective would have a material adverse
effect on our ability to eventually generate revenue and could require us to
reduce the scope of or discontinue our operations.
OUR CLINICAL TRIALS MAY BE SUSPENDED, DELAYED OR TERMINATED AT ANY TIME. EVEN
SHORT DELAYS IN THE COMMENCEMENT AND PROGRESS OF OUR TRIALS MAY LEAD TO
SUBSTANTIAL DELAYS IN THE REGULATORY APPROVAL PROCESS FOR OUR PRODUCT
CANDIDATES, WHICH WILL IMPAIR OUR ABILITY TO GENERATE REVENUE.
We may suspend or terminate clinical trials at any time for various
reasons, including regulatory actions by the FDA or foreign regulatory agencies,
actions by institutional review boards, failure to comply with good clinical
practice requirements and concerns regarding health risks to test subjects. In
addition, our ability to conduct clinical trials for some of our product
candidates, notably AIC and our asthma product candidate, is limited due to the
seasonal nature of ragweed allergy and allergic asthma. Even a small delay in a
trial for any of these product candidates could require us to delay commencement
of the trial until the next appropriate season, which could result in a delay of
an entire year. Consequently, we may experience additional delays in obtaining
regulatory approval for these product candidates.
Suspension, termination or unanticipated delays of our clinical trials for
AIC or our hepatitis B vaccine may:
15
- - adversely affect our ability to commercialize or market any product
candidates we may develop;
- - impose significant additional costs on us;
- - potentially diminish any competitive advantages that we may attain;
- - adversely affect our ability to enter into collaborations, receive
milestone payments or royalties from potential collaborators; and
- - limit our ability to obtain additional financing on acceptable
terms, if at all.
IF WE RECEIVE REGULATORY APPROVAL FOR OUR PRODUCT CANDIDATES, WE WILL BE SUBJECT
TO ONGOING FDA AND FOREIGN REGULATORY OBLIGATIONS AND CONTINUED REGULATORY
REVIEW, WHICH MAY BE COSTLY AND SUBJECT US TO VARIOUS ENFORCEMENT ACTIONS.
Any regulatory approvals that we receive for our product candidates are
likely to contain requirements for post-marketing follow-up studies, which may
be costly. Product approvals, once granted, may be withdrawn if problems occur
after commercialization. Thus, even if we receive FDA and other regulatory
approvals, our product candidates may later exhibit qualities that limit or
prevent their widespread use or that force us to withdraw those products from
the market.
In addition, we or our contract manufacturers will be required to adhere
to Federal regulations setting forth current good manufacturing practice. The
regulations require that our product candidates be manufactured and our records
maintained in a prescribed manner with respect to manufacturing, testing and
quality control activities. Furthermore, we or our contract manufacturers must
pass a pre-approval inspection of manufacturing facilities by the FDA and
foreign regulatory agencies before obtaining marketing approval and will be
subject to periodic inspection by the FDA and corresponding foreign regulatory
agencies under reciprocal agreements with the FDA. Further, to the extent that
we contract with third parties for the manufacture of our products, our ability
to control third-party compliance with FDA requirements will be limited to
contractual remedies and rights of inspection. Failure to comply with regulatory
requirements could prevent or delay marketing approval or require the
expenditure of money or other resources to correct. Failure to comply with
applicable requirements may also result in warning letters, fines, injunctions,
civil penalties, recall or seizure of products, total or partial suspension of
production, refusal of the government to renew marketing applications and
criminal prosecution, any of which could be harmful to our ability to generate
revenue and our stock price.
OUR PRODUCT CANDIDATES IN CLINICAL TRIALS RELY ON A SINGLE LEAD ISS COMPOUND,
1018 ISS, AND MOST OF OUR EARLIER STAGE PROGRAMS RELY ON ISS-BASED TECHNOLOGY.
SERIOUS ADVERSE SAFETY DATA RELATING TO EITHER 1018 ISS OR OTHER ISS-BASED
TECHNOLOGY MAY REQUIRE US TO REDUCE THE SCOPE OF OR DISCONTINUE OUR OPERATIONS.
Our product candidates in clinical trials are based on 1018 ISS, and
substantially all of our research and development programs use ISS-based
technology. If any of our product candidates in clinical trials produce serious
adverse safety data, we may be required to delay or discontinue all of our
clinical trials. In addition, as all of our clinical product candidates contain
1018 ISS, potential collaborators may also be reluctant to establish
collaborations for our products in distinct therapeutic areas due to the common
safety risk across therapeutic areas. If adverse safety data are found to apply
to our ISS-based technology as a whole, we may be required to discontinue our
operations.
A KEY PART OF OUR BUSINESS STRATEGY IS TO ESTABLISH COLLABORATIVE RELATIONSHIPS
TO COMMERCIALIZE AND FUND DEVELOPMENT OF OUR PRODUCT CANDIDATES. WE MAY BE
UNSUCCESSFUL IN ESTABLISHING AND MANAGING COLLABORATIVE RELATIONSHIPS, WHICH MAY
SIGNIFICANTLY LIMIT OUR ABILITY TO DEVELOP AND COMMERCIALIZE OUR PRODUCTS
SUCCESSFULLY, IF AT ALL.
We will have to establish collaborative relationships to obtain domestic
and international sales, marketing and distribution capabilities for our product
candidates. We also intend to enter into collaborative relationships to provide
funding to support our research and development programs. Currently we have
established two collaborative
16
relationships, one with Berna Biotech for our hepatitis B vaccine and hepatitis
B therapeutic product candidates and the second with UCB Farchim, S.A., or UCB,
for AIC and grass allergy immunotherapy. The process of establishing
collaborative relationships is difficult, time-consuming and involves
significant uncertainty. Moreover, even if we do establish collaborative
relationships, our collaborators may seek to renegotiate or terminate their
relationships with us due to unsatisfactory clinical results, a change in
business strategy, a change of control or other reasons. If any collaborator
fails to fulfill its responsibilities in a timely manner, or at all, our
research, clinical development or commercialization efforts related to that
collaboration could be delayed or terminated, or it may be necessary for us to
assume responsibility for activities that would otherwise have been the
responsibility of our collaborator. If we are unable to establish and maintain
collaborative relationships on acceptable terms, we may have to delay or
discontinue further development of one or more of our product candidates,
undertake development and commercialization activities at our own expense or
find alternative sources of funding.
WE RELY ON THIRD PARTIES TO SUPPLY COMPONENT MATERIALS NECESSARY FOR OUR
CLINICAL PRODUCT CANDIDATES AND MANUFACTURE PRODUCT CANDIDATES FOR OUR CLINICAL
TRIALS. LOSS OF THESE SUPPLIERS OR MANUFACTURERS, OR FAILURE TO REPLACE THEM MAY
DELAY OUR CLINICAL TRIALS AND RESEARCH AND DEVELOPMENT EFFORTS AND MAY RESULT IN
ADDITIONAL COSTS, WHICH WOULD PRECLUDE US FROM PRODUCING OUR PRODUCT CANDIDATES
ON COMMERCIALLY REASONABLE TERMS.
We rely on contract relationships with third parties to obtain the
component materials that are necessary for our clinical product candidates and
to manufacture our product candidates for clinical trials. Termination or
interruption of these relationships may occur due to circumstances that are
outside our control, resulting in higher costs or delays in our product
development efforts.
In particular, we have relied on a single supplier to produce our ISS for
clinical trials. ISS is a critical component of both of our AIC and hepatitis B
vaccine product candidates. To date, we have manufactured only small quantities
of ISS ourselves for research purposes. If we were unable to maintain or replace
our existing source for ISS, we would have to establish an in-house ISS
manufacturing capability, incurring increased capital and operating costs and
potential delays in commercializing our product candidates. We or other third
parties may not be able to produce ISS at a cost, quantity and quality that is
available from our current third-party supplier.
In addition, we do not currently have a contract manufacturer for AIC or
enough AIC to supply ongoing clinical and, potentially, commercial needs. We
believe that our existing supplies of AIC are only sufficient for us to conduct
the two-year Phase IIb clinical trial we initiated in February 2004. We intend
to qualify and enter into manufacturing agreements with one or more new
commercial-scale contract manufacturers to produce additional supplies of AIC as
required for completion of clinical trials and commercialization. If we are
unable to complete such agreements, we would have to establish an internal
commercial scale manufacturing capability for AIC, incurring increased capital
and operating costs, delays in the commercial development of AIC and higher
manufacturing costs than we have experienced to date.
WE HAVE OR INTEND TO CONTRACT WITH ONE OR MORE THIRD PARTIES TO CONDUCT OUR
PHASE IIB AND PLANNED PHASE III CLINICAL TRIALS FOR AIC AND PHASE III TRIALS FOR
OUR HEPATITIS B VACCINE. IF THESE THIRD PARTIES DO NOT CARRY OUT THEIR
CONTRACTUAL OBLIGATIONS OR MEET EXPECTED DEADLINES, OUR PLANNED CLINICAL TRIALS
MAY BE DELAYED AND WE MAY FAIL TO OBTAIN THE REGULATORY APPROVALS NECESSARY TO
COMMERCIALIZE AIC OR OUR HEPATITIS B VACCINE.
We are unable to independently conduct our planned clinical trials for AIC
or our hepatitis B vaccine, and we have or intend to contract with third party
contract research organizations to manage and conduct these trials. If these
third parties do not carry out their contractual duties or obligations or meet
expected deadlines, if the third parties need to be replaced or if the quality
or accuracy of the clinical data they obtain is compromised due to failure to
adhere to our clinical protocols or for other reasons, our planned clinical
trials may be extended, delayed or terminated. Any extension, delay or
termination of our trials would delay our ability to commercialize AIC or our
hepatitis B vaccine and generate revenue.
IF ANY PRODUCTS WE DEVELOP ARE NOT ACCEPTED BY THE MARKET OR IF REGULATORY
AGENCIES LIMIT OUR LABELING INDICATIONS OR MARKETING CLAIMS, WE MAY BE UNABLE TO
GENERATE SIGNIFICANT REVENUE, IF ANY.
We do not anticipate that any of our product candidates will be
commercially available until 2007, if at all. Furthermore, even if we obtain
regulatory approval for our product candidates and are able to successfully
17
commercialize them, our product candidates may not gain market acceptance among
physicians, patients, health care payors and the medical community. The FDA or
other regulatory agencies could limit the labeling indication for which our
product candidates may be marketed or could otherwise constrain our marketing
claims, reducing our or our collaborators' ability to market the benefits of our
products to particular patient populations. If we are unable to successfully
market any approved product candidates, or are limited in our marketing efforts
by regulatory limits on labeling indications or marketing claims, our ability to
generate revenues could be significantly impaired.
In particular, treatment with AIC, if approved, will require a series of
injections, and we expect that some of the patients that currently take oral or
inhaled pharmaceutical products to treat their allergies would not consider our
product. We believe that market acceptance of AIC will also depend on our
ability to offer competitive pricing, increased efficacy and improved ease of
use as compared to existing or potential new allergy treatments.
We expect that Asia will be the primary target market for our hepatitis B
vaccine, if approved. While we may seek partners for purposes of commercializing
this product candidate in Asian and other non-U.S. markets in addition to or as
a replacement for our current collaborative partner, which has an exclusive
option to commercialize our hepatitis B vaccine and therapeutic product
candidates, marketing challenges vary by market and could limit or delay
acceptance in any particular country. We believe that market acceptance of our
hepatitis B vaccine will depend on our ability to offer increased efficacy and
improved ease of use as compared to existing or potential new hepatitis B
vaccine products.
WE FACE UNCERTAINTY RELATED TO COVERAGE, PRICING AND REIMBURSEMENT DUE TO HEALTH
CARE REFORM AND HEIGHTENED SCRUTINY FROM THIRD PARTY PAYORS, WHICH MAY MAKE IT
DIFFICULT OR IMPOSSIBLE TO SELL OUR PRODUCT CANDIDATES ON COMMERCIALLY
REASONABLE TERMS.
In both domestic and foreign markets, our ability to generate revenues
from the sales of any approved product candidates in excess of the costs of
producing the product candidates will depend in part on the availability of
reimbursement from third party payors. Existing laws affecting the pricing and
coverage of pharmaceuticals and other medical products by government programs
and other third party payors may change before any of our product candidates are
approved for marketing. In addition, third party payors are increasingly
challenging the price and cost-effectiveness of medical products and services.
Significant uncertainty therefore exists as to coverage and reimbursement levels
for newly approved health care products, including pharmaceuticals. Because we
intend to offer products, if approved, that involve new technologies and new
approaches to treating disease, the willingness of third party payors to
reimburse for our products is particularly uncertain. We will have to charge a
price for our products that is sufficiently high to enable us to recover the
considerable capital resources we have spent and will continue to spend on
product development. Adequate third-party reimbursement may not be available to
enable us to maintain price levels sufficient to realize a return on our
investment in product development. If it becomes apparent, due to changes in
coverage or pricing of pharmaceuticals in our market or a lack of reimbursement,
that it will be difficult, if not impossible, for us to generate revenue in
excess of costs, we will need to alter our business strategy significantly. This
could result in significant unanticipated costs, harm our future prospects and
reduce our stock price.
MANY OF OUR COMPETITORS HAVE GREATER FINANCIAL RESOURCES AND EXPERTISE THAN WE
DO. IF WE ARE UNABLE TO SUCCESSFULLY COMPETE WITH EXISTING OR POTENTIAL
COMPETITORS DESPITE THESE DISADVANTAGES WE MAY BE UNABLE TO GENERATE REVENUE AND
OUR BUSINESS WILL BE HARMED.
We compete with many companies and institutions, including pharmaceutical
companies, biotechnology companies, academic institutions and research
organizations, in developing alternative therapies to treat or prevent allergy,
infectious diseases, asthma and cancer, as well as those focusing more generally
on the immune system. Competitors may develop more effective, more affordable or
more convenient products or may achieve earlier patent protection or
commercialization of their products. These competitive products may render our
product candidates obsolete or limit our ability to generate revenues from our
product candidates. Many of the companies developing competing technologies and
products have significantly greater financial resources and expertise in
research and development, manufacturing, preclinical and clinical testing,
obtaining regulatory approvals and marketing than we do.
18
AIC, if approved, will compete directly with conventional allergy shots
and indirectly with antihistamines, steroid hormones called corticosteroids and
anti-leukotriene agents, which block symptoms caused by inflammatory molecules,
including those produced by GlaxoSmithKline Plc, Merck & Co., Inc. and
AstraZeneca Plc. Since our AIC ragweed allergy treatment would require a series
of injections, we expect that some of the patients that currently take oral or
inhaled pharmaceutical products to treat their allergies would not consider our
product.
Our hepatitis B vaccine, if approved, will compete with existing
three-shot vaccines produced by GlaxoSmithKline Plc and Merck & Co., Inc., among
others, as well as potentially with a two-shot vaccine in clinical development
by GlaxoSmithKline Plc.
Existing and potential competitors may also compete with us for qualified
scientific and management personnel, as well as for technology that would be
advantageous to our business. If we are unable to compete with existing and
potential competitors we may not be able to obtain financing, sell our product
candidates or generate revenues.
WE INTEND TO DEVELOP, SEEK REGULATORY APPROVAL FOR AND MARKET OUR PRODUCT
CANDIDATES OUTSIDE THE U.S., REQUIRING A SIGNIFICANT COMMITMENT OF RESOURCES.
FAILURE TO SUCCESSFULLY MANAGE OUR INTERNATIONAL OPERATIONS COULD RESULT IN
SIGNIFICANT UNANTICIPATED COSTS AND DELAYS IN REGULATORY APPROVAL OR
COMMERCIALIZATION OF OUR HEPATITIS B VACCINE AND THERAPEUTIC PRODUCT CANDIDATES.
We currently intend to conduct certain operations relating to our
hepatitis B vaccine and therapeutic product candidates through Dynavax Asia Pte.
Ltd., or Dynavax Asia, our subsidiary based in Singapore. We intend to
commercialize our hepatitis B vaccine only outside the U.S. due to the presence
of third-party patents in the U.S. covering hepatitis B surface antigen, a key
component of our hepatitis B vaccine, that extend until as late as 2019.
Developing, seeking regulatory approval for and marketing our product candidates
outside the U.S. could impose substantial burdens on our resources and divert
management's attention from domestic operations. We may also conduct operations
in other foreign jurisdictions.
International operations are subject to risk, including:
- - the difficulty of managing geographically distant operations, including
recruiting and retaining qualified employees, locating adequate
facilities and establishing useful business support relationships in the
local community;
- - compliance with varying international regulatory requirements;
- - securing international distribution, marketing and sales capabilities;
- - adequate protection of our intellectual property rights;
- - difficulties and costs associated with complying with a wide variety
of complex international laws and treaties;
- - legal uncertainties and potential timing delays associated with
tariffs, export licenses and other trade barriers;
- - adverse tax consequences;
- - the fluctuation of conversion rates between foreign currencies and
the U.S. dollar; and
- - geopolitical risks.
If we are unable to successfully manage our international operations, we
may incur significant unanticipated costs and delays in regulatory approval or
commercialization of our hepatitis B vaccine and
19
therapeutic product candidates, as well as other product candidates that we may
choose to commercialize internationally, which would impair our ability to
generate revenue.
WE USE HAZARDOUS MATERIALS IN OUR BUSINESS. ANY CLAIMS OR LIABILITIES RELATING
TO IMPROPER HANDLING, STORAGE OR DISPOSAL OF THESE MATERIALS COULD BE TIME
CONSUMING AND COSTLY TO RESOLVE.
Our research and product development involve the controlled storage, use
and disposal of hazardous and radioactive materials and biological waste. We are
subject to Federal, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of these materials and certain waste
products. We are currently in compliance with all government permits that are
required for the storage, use and disposal of these materials. However, we
cannot eliminate the risk of accidental contamination or injury to persons or
property from these materials. In the event of an accident related to hazardous
materials, we could be held liable for damages, cleanup costs or penalized with
fines, and this liability could exceed the limits of our insurance policies and
exhaust our internal resources. We may have to incur significant costs to comply
with future environmental laws and regulations.
WE FACE PRODUCT LIABILITY EXPOSURE, WHICH, IF NOT COVERED BY INSURANCE, COULD
RESULT IN SIGNIFICANT FINANCIAL LIABILITY.
While we have not experienced any product liability claims to date, the
use of any of our product candidates in clinical trials and the sale of any
approved products will subject us to potential product liability claims and may
raise questions about a product's safety and efficacy. As a result, we could
experience a delay in our ability to commercialize one or more of our product
candidates or reduced sales of any approved product candidates. In addition, a
product liability claim may exceed the limits of our insurance policies and
exhaust our internal resources. We have obtained limited product liability
insurance coverage in the amount of $1 million for each occurrence for clinical
trials with umbrella coverage of an additional $4 million. This coverage may not
be adequate or may not continue to be available in sufficient amounts, at an
acceptable cost or at all. We also may not be able to obtain commercially
reasonable product liability insurance for any product approved for marketing in
the future. A product liability claim, product recalls or other claims, as well
as any claims for uninsured liabilities or in excess of insured liabilities,
would divert our management's attention from our business and could result in
significant financial liability.
IF THE COMBINATION OF PATENTS, TRADE SECRETS AND CONTRACTUAL PROVISIONS THAT WE
RELY ON TO PROTECT OUR INTELLECTUAL PROPERTY IS INADEQUATE, THE VALUE OF OUR
PRODUCT CANDIDATES WILL DECREASE.
Our success depends on our ability to:
- obtain and protect commercially valuable patents or the rights to
patents both domestically and abroad;
- operate without infringing upon the proprietary rights of others;
and
- prevent others from successfully challenging or infringing our
proprietary rights.
We will be able to protect our proprietary rights from unauthorized use
only to the extent that these rights are covered by valid and enforceable
patents or are effectively maintained as trade secrets. We try to protect our
proprietary rights by filing and prosecuting U.S. and foreign patent
applications. Legal standards relating to the validity and scope of patent
claims in the biopharmaceutical field can be highly uncertain, are still
evolving and involve complex legal and factual questions for which important
legal principles remain unresolved. The biopharmaceutical patent environment
outside the U.S. is even more uncertain. We may be particularly affected by this
uncertainty, given that several of our product candidates may address market
opportunities outside the U.S. For example, we expect to market our hepatitis B
vaccine, if approved, in foreign countries with high incidences of hepatitis B,
particularly in Asia. The risks and uncertainties that we face with respect to
our patents and other proprietary rights include the following:
20
- we might not have been the first to make the inventions covered by
each of our pending patent applications and issued patents;
- we might not have been the first to file patent applications for
these inventions;
- the pending patent applications we have filed or to which we have
exclusive rights may not result in issued patents or may take longer
than we expect to result in issued patents;
- the claims of any patents that are issued may not provide meaningful
protection;
- our issued patents may not provide a basis for commercially viable
products or may not be valid or enforceable;
- we might not be able to develop additional proprietary technologies
that are patentable;
- the patents licensed or issued to us or our collaborators may not
provide a competitive advantage;
- patents issued to other companies, universities or research
institutions may harm our ability to do business;
- other companies, universities or research institutions may
independently develop similar or alternative technologies or
duplicate our technologies and commercialize discoveries that we
attempt to patent; and
- other companies, universities or research institutions may design
around technologies we have licensed, patented or developed.
We also rely on trade secret protection and confidentiality agreements to
protect our interests in proprietary know-how that is not patentable and for
processes for which patents are difficult to enforce. We cannot be certain that
we will be able to protect our trade secrets adequately. Any leak of
confidential data into the public domain or to third parties could allow our
competitors to learn our trade secrets. If we are unable to adequately obtain or
enforce proprietary rights we may be unable to commercialize our products, enter
into collaborations, generate revenue or maintain any advantage we may have with
respect to existing or potential competitors.
IF THIRD PARTIES SUCCESSFULLY ASSERT THAT WE HAVE INFRINGED THEIR PATENTS AND
PROPRIETARY RIGHTS OR CHALLENGE THE VALIDITY OF OUR PATENTS AND PROPRIETARY
RIGHTS, WE MAY BECOME INVOLVED IN INTELLECTUAL PROPERTY DISPUTES AND LITIGATION
THAT WOULD BE COSTLY, TIME CONSUMING, AND DELAY OR PREVENT DEVELOPMENT OF OUR
PRODUCT CANDIDATES.
We may be exposed to future litigation by third parties based on claims
that our product candidates, proprietary technologies or the licenses on which
we rely, infringe their intellectual property rights, or we may be required to
enter into litigation to enforce patents issued or licensed to us or to
determine the scope or validity of another party s proprietary rights. If we
become involved in any litigation, interference or other administrative
proceedings related to our intellectual property or the intellectual property of
others, we will incur substantial expenses and it will divert the efforts of our
technical and management personnel. Others may succeed in challenging the
validity of our issued and pending claims. If we are unsuccessful in defending
or prosecuting any such claim we could be required to pay substantial damages
and we may be unable to commercialize our product candidates or use these
proprietary technologies unless we obtain a license from the third party. A
license may require us to pay substantial royalties, require us to grant a
cross-license to our technology or may not be available to us on acceptable
terms. In addition, we may be required to redesign our technology so it does not
infringe a third party s patents, which may not be possible or could require
substantial funds and time. Any of these outcomes may require us to change our
business strategy and could reduce the value of our business.
In particular, one of our potential competitors, Coley Pharmaceutical
Group, or Coley, has issued U.S. patent claims, as well as patent claims pending
with the U.S. Patent and Trademark Office, that, if held to be valid, could
require us to obtain a license in order to commercialize one or more of our
formulations of ISS in the U.S., including AIC. In December 2003 the United
States Patent and Trademark Office declared an interference to resolve
21
first-to-invent disputes between a patent application filed by the Regents of
the University of California, which is exclusively licensed to us, and an issued
U.S. patent owned by Coley relating to immunostimulatory DNA sequences. The
declaration of interference names the Regents of the University of California as
senior party, indicating that a patent application filed by the Regents of the
University of California and licensed to us was filed prior to a patent
application owned by Coley that led to an issued U.S. patent. The interference
provides the first forum to challenge the validity and priority of certain of
Coley's patents. If successful, the interference action would establish our
founders as the inventors of the inventions in dispute. If we do not prevail in
the interference proceeding, we may not be able to obtain patent protection on
the subject matter of the interference, which would have a material adverse
impact on our business. In addition, if Coley prevails in the interference, it
may seek to enforce its rights under issued claims, including, for example, by
suing us for patent infringement. Consequently, we may need to obtain a license
to issued and/or pending claims held by Coley by paying cash, granting royalties
on sales of our products or offering rights to our own proprietary technologies.
Such a license may not be available to us on acceptable terms, if at all.
WE RELY ON OUR LICENSES FROM THE REGENTS OF THE UNIVERSITY OF CALIFORNIA.
IMPAIRMENT OF THESE LICENSES OR OUR INABILITY TO MAINTAIN THEM WOULD SEVERELY
HARM OUR BUSINESS.
Our success depends upon our license arrangements with the Regents of the
University of California. These licenses are critical to our research and
product development efforts. Our dependence on these licenses subjects us to
numerous risks, such as disputes regarding the invention and corresponding
ownership rights in inventions and know-how resulting from the joint creation or
use of intellectual property by us and the Regents of the University of
California, or scientific collaborators. Additionally, our agreements with the
Regents of the University of California generally contain diligence or
milestone-based termination provisions. Our failure to meet any obligations
pursuant to these provisions could allow the Regents of the University of
California to terminate any of these licensing agreements or convert them to
non-exclusive licenses. In addition, our license agreements with the Regents of
the University of California may be terminated or may expire by their terms, and
we may not be able to maintain the exclusivity of these licenses. If we cannot
maintain licenses that are advantageous or necessary to the development or the
commercialization of our product candidates, we may be required to expend
significant time and resources to develop or license similar technology.
WE EXPECT THAT OUR STOCK PRICE WILL BE VOLATILE, AND YOUR INVESTMENT MAY SUFFER
A DECLINE IN VALUE.
The market prices for securities of biopharmaceutical companies have in
the past been, and are likely to continue in the future to be, very volatile.
The market price of our common stock may be subject to substantial volatility
depending upon many factors, many of which are beyond our control, including:
- progress or results of any of our clinical trials, in particular any
announcements regarding the progress or results of our planned Phase
III trials for AIC and our hepatitis B vaccine;
- progress of regulatory approval of our product candidates, in
particular AIC and our hepatitis B vaccine, and compliance with
ongoing regulatory requirements;
- our ability to establish collaborations for the development and
commercialization of our product candidates;
- market acceptance of our product candidates;
- our ability to raise additional capital to fund our operations;
- technological innovations, new commercial products or drug discovery
efforts and preclinical and clinical activities by us or our
competitors;
- changes in our intellectual property portfolio or developments or
disputes concerning the proprietary rights of our products or
product candidates;
22
- our ability to obtain component materials and successfully enter
into manufacturing relationships for our product candidates or
establish manufacturing capacity on our own;
- maintenance of our existing licensing agreements with the Regents of
the University of California;
- changes in government regulations;
- issuance of new or changed securities analysts reports or
recommendations;
- general economic conditions and other external factors;
- actual or anticipated fluctuations in our quarterly financial and
operating results; and
- degree of trading liquidity in our common stock.
One or more of these factors could cause a decline in the price of our
common stock. In addition, securities class action litigation has often been
brought against a company following a decline in the market price of its
securities. We may in the future be the target of similar litigation. Securities
litigation could result in substantial costs, divert management's attention and
resources and disrupt our business operations.
IF THE OWNERSHIP OF OUR COMMON STOCK CONTINUES TO BE HIGHLY CONCENTRATED, IT MAY
PREVENT YOU AND OTHER STOCKHOLDERS FROM INFLUENCING SIGNIFICANT CORPORATE
DECISIONS AND MAY RESULT IN CONFLICTS OF INTEREST THAT COULD CAUSE OUR STOCK
PRICE TO DECLINE.
Our executive officers, directors and their affiliates beneficially owned
or controlled approximately 43.25% of our outstanding common stock as of April
30, 2004. Accordingly, these executive officers, directors and their affiliates,
acting as a group, will have substantial influence over the outcome of corporate
actions requiring stockholder approval, including the election of directors, any
merger, consolidation or sale of all or substantially all of our assets or any
other significant corporate transactions. These stockholders may also delay or
prevent a change of control of us, even if such a change of control would
benefit our other stockholders. The significant concentration of stock ownership
may adversely affect the trading price of our common stock due to investors'
perception that conflicts of interest may exist or arise.
ANTI-TAKEOVER PROVISIONS OF OUR CERTIFICATE OF INCORPORATION, BYLAWS AND
DELAWARE LAW MAY PREVENT OR FRUSTRATE A CHANGE IN CONTROL, EVEN IF AN
ACQUISITION WOULD BE BENEFICIAL TO OUR STOCKHOLDERS, WHICH COULD AFFECT OUR
STOCK PRICE ADVERSELY AND PREVENT ATTEMPTS BY OUR STOCKHOLDERS TO REPLACE OR
REMOVE OUR CURRENT MANAGEMENT.
Provisions of our certificate of incorporation and bylaws may delay or
prevent a change in control, discourage bids at a premium over the market price
of our common stock and adversely affect the market price of our common stock
and the voting or other rights of the holders of our common stock. These
provisions include:
- authorizing our Board of Directors to issue additional preferred
stock with voting rights to be determined by the Board of Directors;
- limiting the persons who can call special meetings of stockholders;
- prohibiting stockholder actions by written consent;
- creating a classified board of directors pursuant to which our
directors are elected for staggered three year terms;
- providing that a supermajority vote of our stockholders is required
for amendment to certain provisions of our certificate of
incorporation and bylaws; and
23
- establishing advance notice requirements for nominations for
election to our Board of Directors or for proposing matters that can
be acted on by stockholders at stockholder meetings.
In addition, we are subject to the provisions of the Delaware corporation
law that, in general, prohibit any business combination with a beneficial owner
of 15% or more of our common stock for five years unless the holder's
acquisition of our stock was approved in advance by our board of directors.
BEING A PUBLIC COMPANY INCREASES OUR ADMINISTRATIVE COSTS.
As a public company, we incur significant legal, accounting and other
expenses that we did not incur as a private company. In addition, the
Sarbanes-Oxley Act of 2002, as well as new rules subsequently implemented by the
Securities and Exchange Commission and new listing requirements subsequently
adopted by Nasdaq in response to Sarbanes-Oxley, have required changes in
corporate governance practices of public companies. These new rules,
regulations, and listing requirements have increased our legal and financial
compliance costs, and made some activities more time consuming and costly. For
example, as a result of becoming a public company, we have created several board
committees, adopted additional internal controls and disclosure controls and
procedures, retained a transfer agent and a financial printer, adopted an
insider trading policy, and have all of the internal and external costs of
preparing and distributing periodic public reports in compliance with our
obligations under the securities laws. These new rules and regulations have made
it more difficult and more expensive for us to obtain director and officer
liability insurance. These new rules and regulations could also make it more
difficult for us to attract and retain qualified members of our board of
directors, particularly to serve on our audit committee, and qualified executive
officers.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK
The primary objective of our investment activities is to preserve
principal while at the same time maximize the income we receive from our
investments without significantly increasing risk. Some of the securities that
we invest in may have market risk. This means that a change in prevailing
interest rates may cause the principal amount of the investment to fluctuate. To
minimize this risk, we maintain our portfolio of cash equivalents and
investments in a variety of securities, including commercial paper, money market
funds, government and non-government debt securities and corporate obligations.
Because of the short-term maturities of our current investments, cash
equivalents and marketable securities, we do not believe that an increase in
market rates would have any significant negative impact on the realized value of
our investments.
Interest Rate Risk. We do not use derivative financial instruments in our
investment portfolio. Due to the short duration and conservative nature of our
cash equivalents, and the high quality and conservative nature of our
longer-term investments, which are generally held to maturity, we do not expect
any material loss with respect to our investment portfolio.
Foreign Currency Risk. All of our business is currently transacted in U.S.
dollars. As a result, we have no exposure to foreign exchange rate fluctuations.
ITEM 4. CONTROLS AND PROCEDURES
The Company's management, under the supervision and with the participation
of the Company's Chief Executive Officer (CEO) and Chief Financial Officer
(CFO), performed an evaluation of the effectiveness of the design and operation
of the Company's disclosure controls and procedures as of March 31, 2004. Based
on that evaluation, the CEO and CFO concluded that the Company's disclosure
controls and procedures were effective as of such date to ensure that
information required to be disclosed in the reports that it files or submits
under the Securities Exchange Act of 1934 is recorded, processed, summarized and
reported within the time periods specified in Securities and Exchange Commission
rules and forms. There were no changes in the Company's internal control over
financial reporting that occurred during the Company's last fiscal quarter that
have materially affected, or are reasonably likely to materially affect, the
Company's internal control over financial reporting.
24
PART II
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY
SECURITIES
On February 24, 2004, we completed our initial public offering of
6,900,000 shares of common stock, including 900,000 shares subject to the
underwriters' over-allotment option (which was exercised in full) at a public
offering price of $7.50 per share and realized an aggregate offering price of
$51.8 million. Our registration statement on Form S-1 (Reg. No. 333-109965) was
declared effective by the Securities and Exchange Commission on February 11,
2004. The underwriters for the initial public offering were Bear, Stearns & Co.
Inc., Deutsche Bank Securities Inc. and Piper Jaffray & Co.
We received net proceeds from the offering of approximately $46.4 million.
These proceeds are net of $3.6 million in underwriting discounts and
commissions, $1.4 million in legal, accounting and printing fees and $0.3
million in other expenses. We used a portion of the net proceeds to make a
one-time cash payment of $375,000 to the University of California pursuant to
the terms of several license agreements with them. We intend to use the
remaining net proceeds for general corporate purposes.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits:
EXHIBIT
NUMBER DOCUMENT
- ------ --------
31.1 Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
31.2 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
32.1 Certification of Chief Executive Officer pursuant to Section 902 of the Sarbanes-Oxley Act of
2002
32.2 Certification of Chief Financial Officer pursuant to Section 902 of the Sarbanes-Oxley Act of
2002
(b) There were no reports on Form 8-K filed in the first quarter of 2004.
25
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 thereunto duly authorized.
DYNAVAX TECHNOLOGIES CORPORATION
/s/ Dino Dina May 12, 2004
-----------------------------
Dino Dina
President, Chief Executive
Officer and Director
(Principal Executive Officer)
/s/ William J. Dawson May 12, 2004
-----------------------------
William J. Dawson
Vice President and Chief
Financial Officer
(Principal Financial and
Accounting Officer)
-----------------------------
26