|
Management's Discussion and Analysis
of Financial Conditions and Results of Operations
FIRST QUARTER
2006
INFORMATION
REGARDING FORWARD-LOOKING STATEMENTS
This report contains forward-looking statements. These statements involve known and unknown risks,
uncertainties and other factors which may cause our actual results, performance
or achievements to be materially different from any future results,
performances or achievements expressed or implied by the forward-looking
statements. Forward-looking statements include, but are not limited to,
statements about:
. the marketing
and sales of our products and services;
. our ability to
sustain licensing and other contract-based revenues;
. the benefits of knockout mice programs and, in particular,
our technologies and products, to the pharmaceutical industry;
. the increasing competition we face
in the field of knockout mice from both commercial and government organizations;
.
the value of, and expenses
associated with, our intellectual property;
. the impact of
our NIH contract on future business;
. the requirements
of pharmaceutical and biotechnology companies;
. our future revenues and profitability, including any
revenues from milestone payments and access extension fees, under our DeltaBase
collaboration agreements;
. failures in the drug discovery, development and approval
processes by our partners and collaborators;
.
our patent
applications and licensed technologies;
.
our ability to
attract customers and establish licensing and other agreements;
. our ability to successfully execute our business plan and
to meet contractual obligations, in view of the Company's limited staff; and
.
liquidity and
capital resources.
In some cases, you can identify
forward-looking statements by terms such as "may," "will," "should," "could,"
"would," "expects," "plans," "anticipates," "believes," "estimates,"
"projects," "predicts," "potential" and similar expressions intended to identify
forward-looking statements. These statements reflect our current views with
respect to future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue reliance
on these forward-looking statements.
These forward-looking statements represent our estimates and assumptions
only as of the date of this report.
You should read this report completely
and with the understanding that our actual future results may be materially
different from what we expect. We qualify all of our forward-looking statements
by these cautionary statements.
YOU SHOULD READ THE FOLLOWING DISCUSSION AND ANALYSIS IN
CONJUNCTION WITH OUR FINANCIAL STATEMENTS AND THE NOTES ACCOMPANYING THE
FINANCIAL STATEMENTS.
1. Overview
Deltagen is a provider of research tools
to the biopharmaceutical industry and to the academic research community. Deltagen has generated an inventory of
"knockout mice" in which a single gene has been deleted ("knocked out"). The knockout mice have been analyzed to
determine the phenotypic changes associated with that gene deletion. This phenotypic data has been organized in an
integrated database known as DeltaBase.
DeltaBase contains phenotypic data on 750 different knockout mouse lines. In addition to those 750 knockout mouse
lines, Deltagen has approximately 150 additional knockout mouse lines that have
not been characterized phenotypically.
Deltagen also has approximately 450 knockout lines at the embryonic stem
(ES) cell stage.
Our customers and partners/collaborators
have included some of the world's largest pharmaceutical companies, including
GlaxoSmithKline plc, Merck & Co., Inc., Pfizer Inc., Eli Lilly and Company
and Schering-Plough Research Institute.
We generate revenue from our DeltaBase
and DeltaOne products and programs.
DeltaBase is our proprietary database
that provides information, based on knockout mouse studies, on gene function
and validated gene targets for drug discovery.
Each knockout mouse underwent a standardized, detailed and extensive
analysis in order to determine the function and role that a particular gene
plays in the mouse and that gene's suitability as a drug target.
We have DeltaBase agreements with
GlaxoSmithKline, Pfizer and Merck (the "DeltaBase Collaborations"). Deltagen has received and may continue to
receive revenues associated with annual access extension fees under the
DeltaBase Collaborations where such collaborators opt to continue accessing the
DeltaBase database and associated intellectual property and/or associated
knockout mouse materials. In addition,
Deltagen may receive milestone payments under the DeltaBase Collaborations
based on issuance of certain patents to Deltagen and the collaborators' drug
development and approval activities relating to DeltaBase.
DeltaOne offers access to our portfolio
of knockout mice and/or accompanying phenotypic data, as well as any
corresponding intellectual property, on a gene-by-gene basis.
The
company has a three-year contract, expiring September 2008, with the United
States Government through the National Institutes of Health ("NIH"). Under this contract, the NIH is eligible to
order any of the approximately 750 knockout mouse lines (and related phenotypic
data) that populate DeltaBase. The NIH
is permitted to publish the phenotypic data and make the knockout mouse
materials available for licensing to academic institutions. In September 2005, the NIH placed an initial
delivery order for 129 knockout lines.
No other delivery orders have been submitted.
We derive substantially all of our
revenues from a narrow and limited range of sources. Substantially all of our revenues are derived
from the provision of knockout mouse lines and related phenotypic data to the
biopharmaceutical industry and pursuant to government contracts. Because of continuing consolidation in the
biopharmaceutical industry and the finite number of knockout lines in the
Company's inventory, significant uncertainty exists with respect to the
Company's future revenues.
Our operating results have fluctuated in
the past and are likely to do so in the future, and we do not believe that
period-to-period comparisons of our operating results are a good indication of
our future performance.
2. Critical Accounting
Policies and Estimates
The consolidated financial statements of
Deltagen for the three-month period ended March 31, 2006 have been prepared in
accordance with accounting principles generally accepted in the United States
of America for interim financial information.
These consolidated financial statements have been prepared so that they
present fairly, in the opinion of management, the Company's financial position
and its results of operations and its cash flows for the period presented.
Under our revenue recognition policy,
revenues are recognized when a definitive agreement with a determinable price
exists, product delivery and/or invoicing (in each case where there is
reasonable assurance of meeting customer-specified criteria) have occurred, and
collectibility is reasonably assured. A
change in our revenue recognition policy or changes in the terms of contracts
under which we recognize revenues could have an impact on the amount and timing
of our recognition of revenues.
3. Results of Operations
The Company's
consolidated revenues for the three months ended March 31, 2006 were $1.879 million. The
revenues were primarily attributable to license fees associated with the
provision of knockout mice and related phenotypic data under its DeltaOneTM
program and access extension fees under its DeltaBase®
collaborations. The access
periods under the Company's DeltaBase collaborations expire between June 30, 2006 and March 31, 2007, and there
are no assurances that our DeltaBase collaborators will continue to pay access
extension fees.
The Company had
interest income of $0.100 million for the three months ended March 31, 2006.
Total consolidated
expenses for the three months ended March 31, 2006 were $1.548 million. The expenses were primarily
attributable to salaries and other general and administrative expenses,
third-party royalty and commission obligations, and patent prosecution
expenses. Legal and administrative fees
associated with prosecution of the Company's patent portfolio were $0.373 million
for the three months ended March
31, 2006.
Net income before
taxes for the three months ended March 31, 2006 was $0.431 million.
As of March 31, 2006, the Company
had $10.392 million in cash and cash equivalents.
No revenues from our
NIH contract were recognized and no new delivery orders were placed by the NIH
in the first quarter of 2006. We expect
that revenues under the NIH contract will be highly variable from quarter to
quarter. We currently expect to
recognize approximately $3.2 million from the NIH contract in the second
quarter of 2006.
The
consolidated balance sheet for 2005 is in the process of being audited. The Company currently intends to post the
audited 2005 consolidated balance sheet on the Company's website when the audit
has been completed, together with the auditors' opinion, explanation of
adjustments, and revised notes and revised Management's Discussion and Analysis
of Financial Condition and Results of Operations for such period.
The
consolidated balance sheet for the first quarter of 2006 reflects certain
expected adjustments to the 2005 consolidated balance sheet made in connection
with the audit. The accompanying
expected adjusted 2005 consolidated balance sheet is subject to further changes
or adjustments upon completion of the audit.
4. Stock Option
Grants
On
March 30, 2006, the Company issued under its 2000 Stock Incentive Plan options
to purchase in the aggregate 5,430,000 shares of common stock to the
individuals and in the amounts listed below, each at an option price per share
equal to 47 cents, the average of the high and low prices for the Company's
common stock on March 30, 2006 (the second full day of trading following
release of the Company's 2005 financial results) in the over-the-counter
market, as reported by Pink Sheets LLC.
|
Name
|
Number of Shares
|
Vesting
|
|
Constantine
E. Anagnostopoulos
Director
|
400,000
60,000
|
25% immediately upon the
date hereof. 25% on each of the next
three anniversaries of the date hereof.
33% on each of the next
three anniversaries of the date hereof.
|
|
Thomas
A. Penn
Director
|
400,000
60,000
|
25% immediately upon the
date hereof. 25% on each of the next
three anniversaries of the date hereof.
33% on each of the next
three anniversaries of the date hereof.
|
|
William
A. Scott
Director
|
400,000
60,000
|
25% immediately upon the
date hereof. 25% on each of the next
three anniversaries of the date hereof.
33% on each of the next
three anniversaries of the date hereof.
|
|
Robert
J. Driscoll
President
& Chief Executive Officer
|
2,250,000 (5% of fully diluted common stock)*
|
20% immediately upon the
date hereof. 20% on each of the next
four anniversaries of the date hereof.
|
|
Winston
Thomas
Chief
Operating Officer
|
900,000 (2% of fully diluted common stock)*
|
20% immediately upon the
date hereof. 20% on each of the next
four anniversaries of the date hereof.
|
|
Shera
Kash
VP,
Operations
|
450,000 (1% of fully diluted common stock)*
|
20% immediately upon the
date hereof. 20% on each of the next
four anniversaries of the date hereof.
|
|
Daniel
Ratto
Chief
Financial Officer
|
180,000
|
20% immediately upon the
date hereof. 20% on each of the next
four anniversaries of the date hereof.
|
|
Philippe
O. Chambon
Director
|
30,000
initial grant and 60,000 additional grant
|
33% on each of the next
three anniversaries of the date hereof.
|
|
Martin J. Hernon
Director
|
30,000 initial grant and 60,000 additional grant
|
33% on each of the next
three anniversaries of the date hereof.
|
|
Lawrence
Hill
Director
|
30,000
initial grant and 60,000 additional grant
|
33% on each of the next
three anniversaries of the date hereof; provided, however, that if the Board
requests Mr. Hill's resignation at the end of his first year of service as a
director, his options shall immediately and fully vest.
|
|
Total
|
5,430,000
|
|
* Calculated by taking the
39,223,411 outstanding and adding (a) the 1,380,000 issued to continuing
directors, (b) the 362,857 of director options outstanding, (c) the 312,828 of
employee options outstanding and exercisable, (d) 180,000 issued to D. Ratto,
(e) 270,000 issued to new directors and (f) the amounts issued to the employees
in this grant.
The
Company issued no stock options during the course of its chapter 11 bankruptcy
case, and no stock options other than those listed above have been issued since
the effective date of the Company's plan of reorganization.
5. Comments on Patent
Prosecution Expenses
A significant
portion (approximately 25%) of the Company's total consolidated expenses for
the three-month period ended March
31, 2006 related to the prosecution of the Company's patent
portfolio. Legal and administrative
fees associated with prosecution of the Company's patent portfolio were $0.373
million for the three months ended March 31, 2006. Of
the $7.16 million of total consolidated expenses for the year ended December 31, 2005, patent
prosecution expenses were $1.138 million.
6. Comments on Potential
Milestone and Royalty Payments
The milestone payments under our
DeltaBase Collaborations are triggered only when all of the following
conditions are satisfied: (i) issuance of patents claiming knockout mice; (ii)
such patents having claims with specified language relating to certain recited
phenotypes and/or diseases; and (iii) the progression of a drug candidate
relating to use of DeltaBase data and/or mouse lines to certain specified drug
development and approval milestones.
As of June 1, 2006, the Company had been
issued ten patents claiming knockout mice.
There is significant uncertainty as to how many additional patents, if
any, the Company will be successful in obtaining in the future, and what the
total cost associated with such patent prosecution efforts will be. In addition, satisfaction of the drug
development and approval milestones under our DeltaBase Collaborations depends
solely upon the efforts and success of our pharmaceutical collaborators, which
are not controlled by Deltagen. We may
never know whether our DeltaBase collaborators have been successful in their
drug development efforts relating to DeltaBase.
Our collaborators may also dispute whether milestone triggers have been
satisfied and may resist or refuse to pay milestone payments. Furthermore, the more significant milestone
payment amounts are associated with drug approval, which is a rare event and
takes many years to achieve. As a result
of these factors, there is significant uncertainty as to whether the Company
will receive any milestone payments and, if so, how many milestone payments the
Company may ultimately receive from its DeltaBase Collaborations and what the
value of any such payments may be.
There are
no royalty obligations under the DeltaBase Collaborations. The Company is a party to a few DeltaOne
agreements that specify royalty payments based on sales of approved drugs by
such customers. However, these agreements generally involve a relatively small
fraction of the targets involved in the DeltaBase Collaborations. Therefore, given the relatively few targets
involved in these deals and the low probability of approval and significant
sales for any given drug compound, we currently do not expect that such royalty
payments, if any, would be significant.
7. Comments on Bankruptcy-Related Expenses in
2005
Of the $7.16 million of
total consolidated expenses for the year ended December 31, 2005, $1.14 million
were attributable to expenses related to the legal and administration costs of
Deltagen's chapter 11 bankruptcy case.
Risk Factors Affecting Future Operating Results
There are
numerous risks and uncertainties related to both our business and our industry
that could cause actual results or events to differ materially from those
indicated by forward-looking statements.
For a list
of risk factors that may affect our future operating results, refer to the
"Risk Factors" section of "Management's Discussion and Analysis of Financial
Conditions and Results of Operations" for the year ended December 31, 2005, as posted on the
Company's website (www.deltagen.com). The risk factors listed there are not the
only ones we face and additional risks and uncertainties not presently known to
us or that we currently deem immaterial also may impair or otherwise affect our
business operations.
|