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SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES ACT OF 1934
For Quarter Ended December 31, 2003
Commission File Number: 000-50583
BIOVERIS CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE 80-0076765
(State or other jurisdiction (IRS Employer
incorporation or organization) Identification No.)
16020 INDUSTRIAL DRIVE, GAITHERSBURG, MD 20877
(Address of principal executive offices) (Zip Code)
301-869-9800
(Registrant's telephone number, including area code)
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 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____ No __X__
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.
Class Outstanding at February 13, 2004
Common Stock, $0.001 par value 26,726,950
BIOVERIS CORPORATION
FORM 10-Q
FOR THE QUARTER ENDED DECEMBER 31, 2003
INDEX
PAGE
PART I FINANCIAL INFORMATION
Item 1: CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
Condensed Consolidated Balance Sheets - December 31, 2003 and
March 31, 2003 2
Condensed Consolidated Statements of Operations - For the three and nine
months ended December 31, 2003 and 2002 3
Condensed Consolidated Statements of Cash Flows - For the nine months
ended December 31, 2003 and 2002 4
Notes to Condensed Consolidated Financial Statements 5
Item 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS 19
Item 3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT
MARKET RISK 38
Item 4: CONTROLS AND PROCEDURES 39
PART II OTHER INFORMATION
Item 1: LEGAL PROCEEDINGS 39
Item 6: EXHIBITS AND REPORTS ON FORM 8-K 39
SIGNATURES 40
ITEM 1: CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
BIOVERIS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
UNAUDITED
December 31, 2003 March 31, 2003
----------------- --------------
ASSETS
CURRENT ASSETS:
Accounts receivable, net $ 3,842 $ 5,434
Inventory 5,450 5,448
Prepaid expenses and other 1,024 2,286
------- -------
Total current assets 10,316 13,168
EQUIPMENT AND LEASEHOLD IMPROVEMENTS, NET 5,535 6,456
OTHER NONCURRENT ASSETS:
Investment in joint venture 16,682 9,164
Other 358 372
------- -------
Total assets $32,891 $29,160
======= =======
LIABILITIES AND NET INVESTMENT BY IGEN
CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 4,331 $ 4,758
Accrued wages and benefits 1,930 3,170
Deferred revenue 708 507
------- -------
Total current liabilities 6,969 8,435
DEFERRED REVENUE 14 60
------- -------
Total liabilities 6,983 8,495
COMMITMENTS AND CONTINGENCIES - -
NET INVESTMENT BY IGEN 25,908 20,665
------- -------
Total liabilities and net investment by IGEN $32,891 $29,160
======= =======
See notes to condensed consolidated financial statements.
2
BIOVERIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
UNAUDITED
Three months ended Nine months ended
December 31, December 31,
2003 2002 2003 2002
--------------------------- ----------------------------
REVENUES:
Product sales $ 3,500 $ 5,163 $ 13,914 $ 12,135
Royalty income 250 316 790 829
Contract fees 34 49 104 98
-------- -------- -------- --------
Total revenues 3,784 5,528 14,808 13,062
-------- -------- -------- --------
OPERATING COSTS AND EXPENSES:
Product costs 3,260 2,438 9,033 5,396
Research and development 4,343 5,498 14,595 17,431
Selling, general and administrative 4,647 5,600 13,664 15,798
Merger related costs 3,901 - 4,068 -
-------- -------- -------- --------
Total operating costs and expenses 16,151 13,536 41,360 38,625
-------- -------- -------- --------
LOSS FROM OPERATIONS (12,367) (8,008) (26,552) (25,563)
INTEREST EXPENSE - (3) - (13)
OTHER, NET 125 27 173 196
EQUITY IN LOSS OF JOINT VENTURE (3,742) (3,329) (13,422) (12,784)
-------- -------- -------- --------
NET LOSS $(15,984) $(11,313) $(39,801) $(38,164)
======== ======== ======== ========
PRO FORMA NET LOSS PER COMMON SHARE $ (0.60) $ (0.42) $ (1.49) $ (1.43)
======== ======== ======== ========
PRO FORMA COMMON SHARES OUTSTANDING 26,727 26,727 26,727 26,727
======== ======== ======== ========
See notes to condensed consolidated financial statements.
3
BIOVERIS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
UNAUDITED
Nine months ended
December 31,
2003 2002
-------- --------
OPERATING ACTIVITIES:
Net loss $(39,801) $(38,164)
Adjustments to reconcile net loss to net cash
used for operating activities:
Depreciation and amortization 2,468 3,097
Loss on disposal of equipment 43 85
Expense related to stock options 2,895 290
Equity in loss of joint venture 13,422 12,784
Changes in assets and liabilities:
Accounts receivable 1,592 (1,802)
Inventory (144) (752)
Prepaid expenses and other 1,262 (1,297)
Accounts payable and accrued expenses (1,667) 1,808
Deferred revenue 155 (75)
-------- --------
Net cash used for operating activities (19,775) (24,026)
-------- --------
INVESTING ACTIVITIES:
Expenditures for equipment and leasehold improvements (1,434) (2,622)
Increase in other long-term assets - (12)
Investment in joint venture (20,940) (16,878)
-------- --------
Net cash used for investing activities (22,374) (19,512)
-------- --------
FINANCING ACTIVITIES:
Cash contributed by IGEN, net 42,149 43,581
Payments under capital lease obligations - (43)
-------- --------
Net cash provided by financing activities 42,149 43,538
-------- --------
NET CHANGE IN CASH - -
CASH, BEGINNING OF PERIOD - -
-------- --------
CASH, END OF PERIOD $ - $ -
======== ========
SUPPLEMENTAL DISCLOSURES:
Cash payments of interest $ - $ 13
======== ========
See notes to condensed consolidated financial statements.
4
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)
1. ORGANIZATION AND BASIS OF PRESENTATION
On February 13, 2004, IGEN International, Inc. (IGEN) and Roche Holding Ltd
(Roche) consummated a transaction pursuant to which Roche acquired IGEN and IGEN
simultaneously distributed the common stock of a new company, BioVeris
Corporation (the Company), to its stockholders (the merger). The transaction
occurred in the following steps:
o IGEN restructured its operations so that the Company, a newly formed,
wholly-owned subsidiary of IGEN, assumed IGEN's biodefense, life
science and industrial product lines as well as IGEN's opportunities
in the clinical diagnostics and healthcare fields and the ownership of
IGEN's intellectual property, IGEN's equity interest in Meso Scale
Diagnostics, LLC. (MSD), cash and certain other rights and licenses
currently held by IGEN; and
o A wholly-owned subsidiary of Roche merged with and into IGEN, as a
result of which IGEN became a wholly-owned subsidiary of Roche and the
Company became an independent, publicly-traded company. Simultaneously
with the completion of the merger, certain ongoing commercial
agreements between the Company and certain affiliates of Roche became
effective.
The Company was organized as IGEN Integrated Healthcare, LLC, a Delaware limited
liability company, on June 6, 2003, and converted into BioVeris Corporation, a
newly formed Delaware corporation on September 22, 2003.
Prior to the completion of the merger and related transactions, the assets and
businesses of the Company had historically been owned and operated by IGEN. The
accompanying financial statements have been prepared and are presented as if the
Company had been operating as a separate entity using IGEN's historical cost
basis in the assets and liabilities and including the historical operations of
the businesses and assets transferred to the Company from IGEN as part of the
restructuring. Accordingly, IGEN's net investment in the Company is shown in
lieu of stockholders' equity in the accompanying condensed consolidated balance
sheets. Prior to the completion of the merger and related transactions, IGEN
held all cash in a centralized treasury and provided all of the necessary
funding for the operations of the Company. Accordingly, no cash is reflected on
the accompanying condensed consolidated balance sheets.
For each of the periods presented in the condensed consolidated financial
statements, the Company was fully integrated with IGEN and these financial
statements reflect the application of certain estimates and allocations. The
Company's condensed consolidated statements of operations include all revenues
and costs that are directly attributable to the Company's businesses. In
addition, certain expenses of IGEN have been allocated to the Company using
various assumptions. These expenses include an allocated share of general and
administrative salaries as well as certain other shared costs (primarily
facility, human resources, legal, accounting and other administrative costs).
General and administrative salaries have been allocated primarily based upon an
estimate of actual time spent on the businesses of the Company.
5
Facilities costs and centralized administrative services have been allocated
based upon a percentage of total product sales as well as a percentage of total
headcount. Allocated expenses of $4.6 million, $5.6 million, $13.7 million and
$15.8 million are included in selling, general and administrative expenses in
the accompanying condensed consolidated statements of operations for the three
months ended December 31, 2003 and 2002 and nine months ended December 31, 2003
and 2002, respectively. These allocated expenses were derived from total IGEN
selling, general and administrative expenses of $5.3 million and $6.5 million,
$17.3 million and $18.8 million for the three months ended December 31, 2003 and
2002 and the nine months ended December 31, 2003 and 2002, respectively. In
addition, certain merger related costs have been allocated to the Company based
upon an estimate of actual time spent by professional service providers (see
Note 4 to condensed consolidated financial statements for discussion of other
allocated merger costs). Management believes these allocation methodologies and
estimations are reasonable based upon the nature of the related expenses and
management's knowledge of the level of effort and space required to support the
businesses of the Company. The financial information included herein may not be
indicative of the financial position, results of operations and cash flows of
the Company in the future or what they would have been had BioVeris been
operating as a stand-alone entity in the past.
The consolidated financial statements include the accounts of the Company and
its subsidiaries. All significant intercompany transactions and balances have
been eliminated.
The accompanying condensed consolidated financial statements of the Company have
been prepared in accordance with accounting principles generally accepted in the
United States of America for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, certain
information and footnote disclosures normally included in financial statements
have been condensed or omitted. In the opinion of the Company's management, the
financial statements reflect all adjustments necessary to present fairly the
results of operations for the three and nine month periods ended December 31,
2003 and 2002, the Company's financial position at December 31, 2003 and the
cash flows for the nine month periods ended December 31, 2003 and 2002.
The results of operations for the interim periods are not necessarily indicative
of the results for any future interim period or for the entire year. These
financial statements should be read together with the audited financial
statements and notes for the year ended March 31, 2003 contained in the
Company's Form S-4 Registration Statement filed with the Securities and Exchange
Commission (SEC).
The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the amounts reported in the financial
statements and accompanying notes. Actual results could differ from those
estimates.
2. PRO FORMA BALANCE SHEET
The following pro forma consolidated balance sheet as of December 31, 2003 has
been prepared as if the merger and related transactions were completed as of
December 31, 2003 and should be read in conjunction with the Company's
consolidated financial statements and notes and the other information contained
in this Form 10-Q as well as the Company's Form S-4 Registration Statement filed
with the SEC.
6
BioVeris Pro Forma Consolidated Balance Sheet
As of December 31, 2003
(in thousands, except per share data)
Historical Adjustments Pro Forma
------------ ----------- ----------
ASSETS
CURRENT ASSETS:
Cash $ - $ 223,200 (1) $ 145,000
(50,000) (2)
(35,700) (3)
7,500 (4)
- (5)
Accounts receivable, net 3,842 3,842
Inventory 5,450 5,450
Prepaid expenses and other 1,024 1,024
--------- ---------
Total current assets 10,316 155,316
--------- ---------
EQUIPMENT AND LEASEHOLD IMPROVEMENTS, NET 5,535 5,535
OTHER NONCURRENT ASSETS:
Investment in joint venture (6) 16,682 35,700 (3) 52,382
Other 358 50,000 (2) 50,358
--------- ---------
Total assets $ 32,891 $ 263,591
========= =========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 4,331 $ 4,331
Accrued wages and benefits 1,930 1,930
Deferred revenue 708 708
--------- ---------
Total current liabilities 6,969 6,969
DEFERRED REVENUE 14 14
--------- ---------
Total liabilities 6,983 6,983
--------- ---------
COMMITMENTS AND CONTINGENCIES - - (5) -
STOCKHOLDERS' EQUITY
Preferred stock, par value $0.01 per share, 15,000,000 shares
authorized, issuable in series:
Series A, 600,000 shares designated, none issued, historical and pro forma - - -
Series B, 1,000 shares designated, none issued, historical; 1,000 shares
issued and outstanding, pro forma - 7,500 (4) 7,500
Common stock, par value $0.001 per share, 100,000,000 shares
authorized, 1,000 issued, historical; 26,726,950 shares issued and
outstanding, pro forma - 27 (7) 27
Additional paid-in capital - 223,000 (1) 249,081
25,881 (7)
- (8)
Net investment by IGEN 25,908 (25,908) (7) -
- (8)
--------- ---------
Total stockholders' equity 25,908 256,608
--------- ---------
Total liabilities and stockholders' equity $ 32,891 $ 263,591
========= =========
7
(1) Reflects cash to be transferred from IGEN to BioVeris prior to the
completion of the merger and related transactions.
(2) Assumes payment of $50 million to certain affiliates of Roche for a
worldwide, non-exclusive license under patents that cover certain PCR
inventions.
(3) Assumes payment of the capital contribution of $37.5 million to MSD less
interim funding of $1.8 million to MSD for the month of December 2003 which
has been paid pursuant to an agreement by which 1/12th of IGEN's aggregate
funding commitment under the MSD budget for 2003 would be payable monthly
commencing December 1, 2003 until the completion of the merger. After the
restructuring, and subject to MSD's and MST's right to buy BioVeris's
interests in MSD, BioVeris will hold a 31% voting interest in MSD and after
the capital contribution of $35.7 million to MSD, will be entitled to a
preferred return on $113.6 million.
(4) Assumes purchase by Mr. Samuel Wohlstadter of $7.5 million of shares of
series B preferred stock to be issued by BioVeris. The terms of the Series
B preferred stock economically mirror the class C interest in MSD to be
held by BioVeris.
(5) Pursuant to the tax allocation agreement among Roche, a subsidiary of
Roche, IGEN and BioVeris, BioVeris may be required to make a payment to
IGEN of up to $20 million within 10 days of receiving notice from Roche. If
paid in full, the amount of cash, on a pro forma basis at December 31, 2003
would be approximately$125 million. See Management's Discussion and
Analysis of Financial Condition and Results of Operations, Liquidity and
Capital Resources.
(6) In January 2003, the FASB issued Interpretation No. 46, "Consolidation of
Variable Interest Entities," or FIN 46. FIN 46 provides guidance on
variable interest entities such as the MSD joint venture and the framework
through which an enterprise assesses consolidation of a variable interest
entity. BioVeris will adopt FIN 46 as of January 1, 2004. See Note 3 to
Condensed Consolidated Financial Statements, New Accounting Standards, for
a discussion of consolidation accounting for the investment in joint
venture beginning January 1, 2004.
(7) Reflects the reclassification of net investment by IGEN to common stock and
additional paid-in capital upon distribution of 26,726,950 shares of
BioVeris common stock.
(8) BioVeris's net loss will increase in the three months ended March 31, 2004
as a result of BioVeris's recognition of an allocated one-time noncash
compensation charge associated with the cancellation of IGEN stock options
and the payment of the merger consideration for each share covered by IGEN
stock options in connection with the merger. See Note 4 to Condensed
Consolidated Financial Statements, Stock Option Plans.
8
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Concentration of Credit Risk -- During the three months ended December 31, 2003
and 2002 and the nine months ended December 31, 2003 and 2002, agencies of the
U.S. government accounted for 18%, 36%, 17% and 26% of total revenue,
respectively, and 18% and 43% of total accounts receivable as of December 31,
2003 and March 31, 2003, respectively.
Allowance for Doubtful Accounts -- The Company maintains reserves on customer
accounts where estimated losses may result from the inability of its customers
to make required payments. These reserves are determined based on a number of
factors, including the current financial condition of specific customers, the
age of accounts receivable balances and historical loss rates.
Inventory -- Inventory is recorded at the lower of cost or market using the
first-in, first-out method and consists of the following:
December 31, 2003 March 31, 2003
-------------- --------------
Finished goods $ 2,179 $ 2,234
Work in process 503 869
Raw materials 2,768 2,345
--------- --------
$ 5,450 $ 5,448
========= ========
Equipment and Leasehold Improvements -- Equipment and leasehold improvements are
carried at cost, less accumulated depreciation and amortization. Depreciation on
equipment, which includes lab instruments and furniture, is computed over the
estimated useful lives of the assets, generally three to five years, using
straight-line or accelerated methods. Leasehold improvements are amortized on a
straight-line basis over the life of the lease.
Capitalized Software Costs -- Software development costs incurred after
technological feasibility is established are capitalized in accordance with
Statement of Financial Accounting Standards (SFAS) No. 86, "Accounting for the
Costs of Computer Software to Be Sold, Leased, or Otherwise Marketed." To date,
software development has been substantially completed concurrently with the
establishment of technological feasibility, and accordingly, no costs have been
capitalized to date.
Evaluation of Long-Lived Assets -- The Company evaluates the potential
impairment of long-lived assets whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be fully recoverable. In
evaluating the recoverability of an asset, management's policy is to compare the
carrying amount of an asset with the projected undiscounted future cash flow.
Management believes no impairment of these assets exists as of December 31, 2003
and March 31, 2003.
Warranty Reserve -- The Company warrants its products against defects in
material and workmanship for one year after sale and records estimated future
warranty costs at the time revenue is recognized. A reserve for future warranty
claims is recorded based upon management's review of historical claims,
supplemented by expectations of future costs. The Company also offers extended
warranty arrangements to customers, for which related costs are recorded as
incurred.
9
Warranty reserve activity is as following:
Balance at March 31, 2003 $ 250
Provisions recorded 1,231
Actual costs incurred (1,231)
--------
Balance at December 31, 2003 $ 250
========
Fair Value of Financial Instruments -- The carrying amounts of the Company's
financial instruments, which include accounts receivable, accounts payable and
accrued expenses, approximate their fair value due to their short maturities.
Revenue Recognition -- The Company derives revenue principally from three
sources: product sales, royalty income and contract fees.
Product sales revenue is recognized when persuasive evidence of an arrangement
exists, the price to the buyer is fixed and determinable, collectibility is
reasonably assured and the product is shipped to the customer thereby
transferring title and risk of loss. For instrument sales, the instrument and
the related installation are considered to be separate elements under EITF
00-21. Revenue is recognized for the instrument upon shipment and is recognized
for the installation when complete based upon the residual value method. For
instrument and reagent sales, there is no option of return and refund, only the
option to repair or replace. Other than the installation required for the
instruments, there are no contingencies, allowances or other post-sale
obligations. For instrument leases, the instrument rental and related minimum
reagent purchases are considered to be separate elements under EITF 00-21 and,
accordingly, the sales price is allocated to the two elements based upon their
relative fair values. Instrument rental revenue is recognized ratably over the
life of the lease agreements and the related reagent revenue is recognized upon
shipment. Revenue associated with extended warranty arrangements is recognized
over the term of the extended warranty contract.
Royalty income is recorded when earned, based on information provided by
licensees.
Revenue from services performed under contracts is recognized when obligations
under the contract have been satisfied. The satisfaction of obligations may
occur over the term of the underlying customer contract, if the contract is
based on the achievement of certain "milestones," or may occur at the end of the
underlying customer contract, if based only upon delivery of the final work
product.
Research and Development -- Research and development costs are expensed as
incurred.
Foreign Currency -- Gains and losses from foreign currency transactions, such as
those resulting from the settlement of foreign receivables or payables, are
included in the results of operations as incurred. These amounts were not
material during the three and nine months ended December 31, 2003 and 2002.
10
Income Taxes -- The assets and businesses of the Company have historically been
owned and operated by IGEN. The Company was not a separate legal or tax entity
and the operating results of the Company were included in IGEN's consolidated
Federal and state income tax returns. As a result, income taxes have been
calculated as if the Company was a stand-alone entity filing a separate tax
return.
Stock-Based Compensation -- The Company has elected to follow the recognition
and measurement principles of Accounting Principles Board Opinion No. 25,
"Accounting for Stock Issued to Employees," and related interpretations in
accounting for employee stock options and, accordingly, will not recognize
compensation cost for options granted under its 2003 stock incentive plan whose
exercise price equaled the market value of a share of the underlying common
stock on the date of grant.
The Company did not have any stock option grants. The following table
illustrates the effect on net loss and net loss per share as if IGEN had applied
the fair value recognition provisions of SFAS No. 123, "Accounting for
Stock-Based Compensation," as amended by SFAS No. 148, "Accounting for
Stock-Based Compensation -- Transition and Disclosure -- An Amendment of SFAS
No. 123," to stock-based employee compensation and the resulting costs
attributable to the Company's employees were reflected in the condensed
consolidated financial statements:
Three months ended Nine months ended
December 31, December 31,
2003 2002 2003 2002
----------------------------- ------------------------
Net loss, as reported $ (15,984) $ (11,313) $ (39,801) $ (38,164)
Deduct: Stock-based employee compensation recognized
under intrinsic value method 2,458 - 2,458 -
Add: Total stock-based employee compensation
expense determined under fair value method (2,926) (610) (3,821) (1,862)
--------- --------- --------- ---------
Net loss, as adjusted $ (16,452) $ (11,923) $ (41,164) $ (40,026)
========= ========== ========= =========
Net loss per share:
Net loss per common share, as reported $ (0.60) $ (0.42) $ (1.49) $ (1.43)
Net loss per common share, as adjusted $ (0.62) $ (0.45) $ (1.54) $ (1.50)
All per share information for the Company is based on the number of shares of
common stock of the Company outstanding upon completion of the merger and
related transactions. The net loss, as adjusted, and net loss per share, as
adjusted, disclosed above is not representative of the effects on net loss and
net loss per share on an as adjusted basis in future periods, as future periods
will include grants by the Company of options for the Company common stock.
The fair value of options for IGEN common stock was estimated at the date of
grant using a Black-Scholes option pricing model with the following assumptions:
11
Three months ended Nine Months Ended
December 31, December 31,
2003 2002 2003 2002
--------------------------------------
Expected dividend yield - 0% 0% 0%
Expected stock price volatility - 68% 65% 68%
Risk-free interest rate - 3.0% 2.3% 3.4%
Expected option term (in years) - 5 5 5
Based on this calculation, the weighted average fair value of options granted
during the three months ended December 31, 2002 and nine months ended December
31, 2003 and 2002 was $16.48, $21.09 and $19.29, respectively. No options were
granted during the three months ended December 31, 2003.
Pro Forma Net Loss Per Share -- The Company uses SFAS No. 128, "Earnings per
Share," for the calculation of basic and diluted earnings per share. For all
periods presented, the pro forma net loss per share is based on the number of
common shares outstanding upon completion of the merger and related
transactions. (See Note 1)
New Accounting Standards -- In December 2002, the FASB issued SFAS No. 148,
"Accounting for Stock-Based Compensation -- Transition and Disclosure -- an
amendment of SFAS No. 123" (SFAS 148). SFAS 148 amends SFAS 123, "Accounting for
Stock-Based Compensation" (SFAS 123), to provide alternative methods of
voluntarily transitioning to the fair value based method of accounting for
stock-based employee compensation. SFAS 148 also amends the disclosure
requirements of SFAS 123 to require disclosure of the method used to account for
stock-based employee compensation and the effect of the method on reported
results in both annual and interim financial statements. This pronouncement is
effective for both annual and interim periods beginning after December 15, 2002.
The Company has elected to follow the recognition and measurement principles of
Accounting Principles Board Opinion No. 25, "Accounting For Stock Issued to
Employees," in its accounting for employee stock options. In accordance with
SFAS 148, the Company has adopted the annual and interim period disclosure
requirements.
In January 2003, the FASB issued Interpretation No. 46, "Consolidation of
Variable Interest Entities," or FIN 46. FIN 46 provides guidance on variable
interest entities such as the MSD joint venture and the framework through which
an enterprise assesses consolidation of a variable interest entity. The Company
will adopt FIN 46 as of January 1, 2004 and has determined that MSD qualifies as
a variable interest entity based upon the following rationale:
o The Company has provided substantially all of MSD's funding since
inception through capital contributions consisting of class B and C
non-voting equity interests. Such funding is not considered "at risk" as
the investments do not participate significantly in the profits of MSD
given their stated return rates. As such the "at risk" equity of MSD is
insufficient to absorb MSD's expected future losses.
12
o The Company holds 31% of the voting rights in MSD while providing 100%
of MSD's funding, and the Company is thereby considered to be involved
in all of MSD's activities as defined under FIN 46.
As the merger and related transactions do not change the design of or ownership
interests in MSD in such a manner that could affect the status of MSD as a
variable interest entity or the Company as the primary beneficiary, the Company
does not believe they are deemed to be events that would require reassessment of
the Company's previous conclusion that MSD qualifies as a variable interest
entity under FIN 46 with the Company as the primary beneficiary. Accordingly,
beginning January 1, 2004 and continuing subsequent to the completion of the
merger and related transactions, the Company will consolidate the financial
results of MSD. Under the transition guidance of FIN 46 because MSD was created
before February 1, 2003, the Company will measure the assets, liabilities and
noncontrolling interests of MSD as of January 1, 2004 for purposes of the
initial consolidation. The amounts of the assets, liabilities and noncontrolling
interests will be reflective of their respective carrying amounts had FIN 46
been effective when the Company first met the conditions to be the primary
beneficiary of MSD upon MSD's inception in 1995. Such carrying amounts are
expected to equal MSD's recorded values, which as of December 31, 2003, were
approximately $18.8 million, $1.7 million and $10,000, respectively. As the
Company has historically recorded and will continue to record approximately 100%
of MSD's losses, it is anticipated that upon implementation of FIN 46, the
consolidated net assets of MSD will approximate the book value of the Company's
investment in joint venture. As such, consolidation accounting will require
certain reclassifications within the Company's consolidated financial
statements, but it is not expected to materially affect its financial position
or net loss. The required balance sheet reclassifications will reclassify the
amounts formerly recorded on a "net" basis as investment in joint venture to be
reflected on a "gross" basis primarily as cash, accounts receivable, inventory,
fixed assets, accounts payable and accrued expenses. The required statement of
operations reclassifications will reclassify the amounts formerly recorded on a
"net" basis as equity in loss of joint venture to be reflected on a "gross"
basis primarily as revenue, product costs, research and development expenses and
selling, general and administrative expenses.
In April 2003, the FASB issued SFAS No. 149, "Amendment of SFAS No. 133 on
Derivative Instruments and Hedging Activities" (SFAS 149). SFAS 149 amends and
clarifies financial accounting and reporting for derivative instruments,
including certain derivative instruments embedded in other contracts, and for
hedging activities under SFAS No. 133, "Accounting for Derivative Instruments
and Hedging Activities." The amendments set forth in SFAS 149 require that
contracts with comparable characteristics be accounted for similarly. SFAS 149
is generally effective for contracts entered into or modified after June 30,
2003 and for hedging relationships designated after June 30, 2003. The
implementation of SFAS 149 did not have a material effect on the Company's
financial position, results of operations or cash flows.
In May 2003, the FASB issued SFAS No. 150, "Accounting for Certain Financial
Instruments with Characteristics of Both Liabilities and Equity" (SFAS 150).
SFAS 150 establishes standards regarding the classification and measurement of
certain financial instruments with characteristics of both liabilities and
equity. SFAS 150 is effective for financial instruments entered into or modified
after May 31, 2003, and otherwise is effective at the beginning of the first
interim period beginning after June 15, 2003. The implementation of SFAS 150 did
not have a material effect on the Company's financial position, results of
operations or cash flows.
13
4. STOCK OPTION PLANS
In September 2003, the board of directors of the Company adopted, subject to
IGEN stockholder approval, the BioVeris 2003 Stock Incentive Plan (Stock Plan).
Up to 5.3 million shares of common stock of the Company (subject to adjustment
in the event of stock splits and other similar events) may be issued pursuant to
awards granted under the Stock Plan.
The Stock Plan provides for the grant of incentive stock options intended to
qualify under Section 422 of the Internal Revenue Code of 1986, as amended,
non-statutory stock options, restricted stock awards and other stock-based
awards, including the grant of shares based upon certain conditions, the grant
of securities convertible into common stock of the Company and the grant of
stock appreciation rights (collectively, Awards).
Employees, officers, directors, consultants and advisors, including any
individuals who have accepted an offer for employment, of the Company and its
subsidiaries are eligible to be granted awards under the Stock Plan. Incentive
stock options may only be granted to employees of the Company and its
subsidiaries. The Stock Plan was approved by an affirmative vote of the IGEN
stockholders on February 13, 2004.
In connection with the transfer of IGEN employees to the Company, the Company's
Board of Directors approved the grant to the Company's employees of options
to purchase 100 shares of BioVeris common stock. Each option will have an
exercise price equal to fair market value on the date of grant and will vest in
full one year from the date of grant.
All IGEN stock options were canceled in connection with the merger and related
transactions and the holder of any such options has the right to receive for
each share covered by such option cash from Roche equal to the excess of $47.25
over the exercise price of such option and one share of the Company's common
stock. In connection with such cancellation of IGEN stock options and the
payment of the merger consideration for each share covered by IGEN stock
options, the Company will record an allocated noncash compensation charge for
each IGEN stock option. In calculating the noncash compensation charge
associated with the merger and related transactions, the Company applied the
guidance of FIN 44 for employee stock options and SFAS 123 for nonemployee stock
options. With respect to employee stock options, FIN 44 guidance provides that
the compensation charge is calculated based upon the difference between the last
trading price of IGEN common stock ($64.09 per share) and the exercise price of
each employee stock option, including both vested and unvested employee stock
options. With respect to nonemployee stock options, SFAS 123 guidance provides
that the compensation charge is calculated based upon the incremental fair value
of the nonemployee stock options resulting from the merger. Upon completion of
the merger and related transactions, there were options to acquire 1,277,109
shares of IGEN common stock, with a weighted average exercise price of $19.23
per share, that will result in a noncash compensation charge of approximately
$37 million for the three months ended March 31, 2004. This amount is an
allocation from IGEN to the Company based upon an estimate of actual time spent
on BioVeris matters by each option holder.
14
In addition, in connection with the transfer of employees from IGEN to MSD on
December 31, 2003 pursuant to the restructuring described in Note 1, IGEN
accelerated the vesting of all unvested stock options held by such employees who
accepted the offer of employment with MSD. Pursuant to the guidance of FIN 44, a
noncash compensation charge of approximately $2.5 million was recorded during
the three months ended December 31, 2003 representing the difference between the
trading price of IGEN common stock on December 31, 2003 and the exercise price
of each employee stock option for which vesting was accelerated. This
compensation charge is a component of merger related costs in the accompanying
condensed consolidated statement of operations.
5. MESO SCALE DIAGNOSTICS JOINT VENTURE
MSD is a joint venture formed by MST and IGEN in 1995. MSD was formed for the
development, manufacture, marketing and sale of products utilizing a combination
of MST's multi-array technology together with IGEN's technology. MST is a
company established and wholly-owned by Jacob Wohlstadter, a son of the
Company's chairman and chief executive officer. In August 2001, IGEN amended the
MSD joint venture agreement, the MSD limited liability company agreement and
certain license and other agreements with MSD and MST to continue the MSD joint
venture and entered into various related agreements (the MSD agreements). An
independent committee of the IGEN board of directors, the Joint Venture
Oversight Committee (JVOC), with the advice of independent advisors and counsel,
negotiated and approved the MSD agreements. As part of the merger and related
transactions, IGEN's equity interest in the MSD joint venture has been
transferred to the Company and the MSD agreements have been assigned to the
Company.
MSD manufactures, markets and sells instrument systems, including the Sector HTS
and the Sector PR, which combine MST's multi-array technology and ECL
technology. The Sector HTS is an ultra high throughput drug discovery system
engineered for applications such as high throughput screening and large-scale
proteomics. The Sector PR is a smaller system designed for benchtop applications
such as assay development, research in therapeutic areas, cellular biology and
medium throughput screening. MSD also manufactures and markets a line of its own
reagents, assays and plates that are used on these systems. MSD commenced
product sales in October 2002.
Under the MSD agreements, IGEN's funding commitment was based on an annual
budget of MSD approved by the JVOC, a committee of the IGEN board of directors
consisting of independent directors. The JVOC approved funding for MSD by IGEN
for the period from January 1, 2003 to November 30, 2003 in an amount of $20.6
million, subject to a permitted variance of 15%. IGEN's funding commitment was
satisfied in part through in-kind contributions of scientific and administrative
personnel and shared facilities. For the nine months ended December 31, 2003 and
2002, IGEN made total contributions to MSD of $20.9 million and $16.9 million,
respectively, including $3.7 million in the nine months ended December 31, 2003,
which constituted discretionary funding relating to the permitted budget
variances from prior years.
15
Separate from and in addition to IGEN's funding commitment under the MSD
agreements for the period from January 1, 2003 to November 30, 2003, the Company
agreed to make a final capital contribution of $37.5 million to MSD following
the completion of the merger. Of the $37.5 million, Samuel Wohlstadter,
Company's chairman and chief executive officer, will fund any amount in excess
of $30.0 million (including any interim funding provided by IGEN as described in
the next sentence) through the purchase of the Company's series B preferred
stock that economically mirror the class C interests in MSD to be held by the
Company. In addition, as the merger was not completed prior to December 1, 2003,
IGEN agreed to provide continued interim funding to MSD, payable monthly on the
first day of each month commencing on December 1, 2003 until the completion of
the merger. The monthly funding was equal to approximately $1.7 million, which
is 1/12th of IGEN's aggregate funding commitment under the MSD budget for 2003
approved by the JVOC. Such interim funding, which totaled $5.2 million from
December 1, 2003 through February 1, 2004, will reduce the amount of the
Company's final capital contribution to $32.3 million.
After the restructuring, and subject to MSD's and MST's right to buy the
Company's interests in MSD, the Company replaced IGEN as a member of MSD and
holds a 31% voting equity interest in MSD and is entitled to a preferred return
on $77.8 million of the funds previously invested by IGEN in MSD through
December 31, 2003 and on the additional funds invested by IGEN and the Company
thereafter. This preferred return would be payable out of a portion of both
future profits and certain third-party financings of MSD, generally before any
payments are made to other equity holders. Although MST owns the remaining 69%
voting equity interest in MSD, the Company generally has the right to approve
significant MSD governance matters. In exercising this right, an independent
committee of the Company's board of directors must consider the Company's
interests and the interests of the Company's stockholders while also taking into
consideration the interests of MSD.
The Company and MST are the sole members of MSD, and each holds one seat on
MSD's two-member board of managers. After the restructuring, Dr. Richard Massey,
the Company's president and chief operating officer, became the Company's
representative on the MSD board of managers and also serves as the treasurer and
secretary of MSD. The other member of the MSD board of managers is Mr. Jacob
Wohlstadter, who is the sole owner of MST and serves as president and chief
executive officer of MSD.
Under the terms of one of the MSD agreements, IGEN granted to MSD a worldwide,
perpetual, exclusive license (with certain exceptions) to IGEN's technology,
including ECL technology, for use in MSD's research program, defined in the MSD
agreements. If the Company ceases to be a member of MSD, it will become entitled
to receive royalty payments from MSD on all products developed and sold by MSD
using the Company's patents.
MST holds a worldwide, perpetual, non-exclusive sublicense from MSD for certain
non-diagnostic applications of the Company's technology. The Company is entitled
to receive royalty payments from MST on any products developed and sold by MST
using the patents the Company received as part of the restructuring.
16
As part of the merger agreement and related transaction agreements, the Company,
IGEN and MSD agreed that the MSD joint venture agreement would expire upon
completion of the merger and related transactions. After the expiration of the
MSD joint venture agreement, the Company may not use the improvements granted to
it by MSD if doing so would compete with MSD in the diagnostic field or use
research technologies defined in the MSD agreements.
Upon completion of the merger and related transactions, the MSD joint venture
agreement expired. As a result, MSD and MST has the right to purchase for a
purchase price equal to fair market value (to be determined in accordance with
the provisions and procedures set forth in the MSD agreements, which will
include a determination by appraisers if the parties are unable to agree on fair
market value) less a 7.5% discount factor, the Company's entire interest in MSD
including the Company's preferred interests that entitle it to a preferred
return on its investment in MSD. If MSD or MST exercises this right, it will be
required to pay the Company the outstanding purchase price plus simple
(cumulated, not compounded) interest at the fixed annual rate of 0.5% over the
prime rate in effect on the date that MSD or MST, as the case may be, elects to
purchase the interests. The purchase price is payable over time in installments
equal to the sum of 5% of MSD net sales, as determined in accordance with the
MSD agreements, and 20% of the net proceeds realized by MSD from the sale of its
debt or equity securities in any third-party financing after the date of the
sale of the Company's interest in MSD. In the event such future net sales or
third-party financings do not materialize, the Company will not receive any
payments from MSD or MST, as the case may be, for the purchase of the Company's
interest in MSD. As security for the payment obligation, the Company will hold a
security interest in the interests in MSD that are being purchased. MST or MSD,
as the case may be, may repay all or any part of the outstanding purchase price
plus accrued interest at any time and from time to time without penalty.
Following the expiration of the MSD joint venture agreement, many of the
licenses and other arrangements with MSD and MST assigned to the Company
continued indefinitely in accordance with their terms.
Following the expiration of the MSD joint venture agreement, MSD is entitled to
continue to lease certain facilities and related equipment from the Company
(including laboratory facilities located in the Company's corporate
headquarters) pursuant to the terms of the existing sublease agreements with
MSD. The term of each sublease will expire one day prior to the expiration of
the prime lease for that facility. Each sublease agreement provides that,
subject to certain exceptions, the Company must exercise all available extension
rights under the prime lease. Following expiration of the MSD joint venture
agreement, each of MSD and the Company may unilaterally terminate any or all of
the subleases by providing at least 18 months prior written notice of
termination. If the Company elects to terminate a sublease for a facility, MSD
may elect, notwithstanding any termination of the sublease, to remain in the
subleased facility after the 18-month period expires for any period of time
selected by MSD, but not longer than one day prior to the expiration of the
prime lease (including any extensions of the prime lease).
17
After a notice of termination of a sublease has been sent, MSD will be required
to pay its pro rata share of all rental and other expense incurred by the
Company under the prime lease. MSD and MST may elect, if either exercises its
right to purchase the Company's interests in MSD, to have its rental and expense
payment obligations for the 18-month period included in the purchase price of
those interests in MSD.
MSD has an employment agreement with Mr. Jacob Wohlstadter, its president and
chief executive officer, the current term of which runs through November 30,
2004. The term of the employment agreement will automatically renew for a
12-month period on November 30 of each year unless either MSD or Mr. Jacob
Wohlstadter gives notice of termination no later than 180 days prior to that
renewal date. That employment agreement provides for a salary at the annual rate
of $250,000 through November 30, 2003. Thereafter, the salary is to be increased
as agreed to by MSD and Mr. Jacob Wohlstadter. In addition, Mr. Jacob
Wohlstadter is also eligible to receive, at the discretion of the JVOC of the
Company's board of directors, an annual cash bonus in an amount not to exceed
20% of his annual salary. During the year ended December 31, 2003, Mr. Jacob
Wohlstadter received $250,000 from his employment at MSD. Mr. Jacob Wohlstdater
is also entitled to receive pension, welfare and fringe benefits comparable to
those received by senior executives of the Company and other insurance benefits.
If MSD terminates the employment agreement without cause, or Mr. Jacob
Wohlstadter terminates the employment agreement for good reason (which includes
a "change in control" of the Company, as defined), Mr. Jacob Wohlstadter will be
entitled to receive, in addition to salary and pro rata bonus and adjustments
earned through the 60th day following the notice of termination, an amount equal
to from 3 to 12 times (depending on the reason for the termination) the monthly
pro rata salary, bonus and adjustments in effect at the time of the termination.
Under the employment agreement Mr. Jacob Wohlstadter is also entitled to receive
a gross-up for any "parachute" excise tax that may be imposed on payments made
or benefits provided pursuant to the agreement. The Company is obligated to
maintain in effect directors and officer's liability insurance coverage for Mr.
Jacob Wohlstadter and to pay Mr. Jacob Wohlstadter the applicable salary, pro
rata bonus and adjustments in effect at the time of termination as described
above and a gross-up for any "parachute" excise tax that may be imposed.
MSD and Mr. Jacob Wohlstadter have each agreed that the merger and related
transactions will not constitute a change in control for purposes of the MSD
agreements and the employment agreement. The Company will also indemnify Mr.
Jacob Wohlstadter against certain liabilities, including liability from the MSD
joint venture relating to the period of IGEN's or the Company's involvement with
MSD. In addition, the Company will be obligated under the MSD agreements to
indemnify each board member or officer of MSD with respect to any action taken
by such person prior to the termination of the MSD joint venture agreement by
reason of the fact that such person is or was a board member or an officer of
MSD. With respect to such indemnification obligations, there are no pending or
known matters covered by these indemnification provisions that would have a
material effect on the Company's financial position or results of operations.
Since inception of the MSD joint venture, the equity method has been utilized to
account for this investment. Prior to July 1, 2001, given MSD's status as a
development stage enterprise without having established technological
feasibility of its intended product offering, the Company considered its
investments in MSD to be other than temporarily impaired.
18
As such, any residual investment book value, after recognizing the Company's
share of MSD losses in accordance with the equity method, was written off upon
contribution. All expenses related to the MSD investment prior to July 1, 2001
were recorded as research and development expenses based upon the significance
and character of the MSD losses as substantially all contributions supported
research and development initiatives. Beginning on July 1, 2001, taking into
account the progress made by MSD in the development of its products, the Company
determined that no additional impairments were required to its prospective
contributions and thus ceased writing-off the amount of its contributions to MSD
that were in excess of MSD's losses. At that time, MSD was transitioning from a
development stage entity to a commercial enterprise and milestones establishing
the continued viability of MSD were first achieved in the quarter ended
September 30, 2001. For example, prototypes had been assembled demonstrating
product feasibility, and MSD was anticipating initial product launch in
approximately one year. As a result of this transition, MSD's expenses were no
longer primarily research and development. Accordingly, since July 1, 2001, the
Company has recorded only its proportionate share of MSD losses, representing
approximately 100% of MSD's losses, for each respective period as equity in loss
of joint venture consistent with accounting for equity method investments.
MSD-related losses included in equity in loss of joint venture were $3.7
million, $3.3 million, $13.4 million and $12.8 million for the three months
ended December 31, 2003 and 2002 and the nine months ended December 31, 2003 and
2002, respectively. During the three months ended December 31, 2003 and 2002 and
the nine months ended December 31, 2003 and 2002, operating costs allocated to
MSD by the Company in connection with shared personnel and facilities totaled
$1.9 million, $3.3 million, $5.7 million and $8.3 million, respectively. Since
July 1, 2001, these allocated operating costs reduced certain operating costs
and expenses and increased equity in loss of joint venture in the accompanying
condensed consolidated statements of operations. The Company's investment in
joint venture totaled $16.7 million and $9.2 million at December 31, 2003 and
March 31, 2003, respectively. See Note 3 for discussion of consolidation
accounting of the MSD investment as of January 1, 2004.
6. COMMITMENTS AND CONTINGENCIES
License Payment -- In connection with the merger and related transactions, the
Company has committed to pay certain affiliates of Roche a fee of $50 million
after the completion of the merger for a worldwide, non-exclusive license under
patents that cover certain PCR inventions.
Tax Allocation Contingency -- Pursuant to the tax allocation agreement among
Roche, a subsidiary of Roche, IGEN and the Company, the Company may be required
to pay IGEN up to $20 million within 10 days of receiving notice from Roche to
the extent that the average of the high and low trading prices of the Company's
common stock on the first day of trading of the Company's common stock after the
completion of the merger exceeds a specified threshold.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
19
This Management's Discussion and Analysis of Financial Condition and Results of
Operations as of December 31, 2003 and for the three and nine month periods
ended December 31, 2003 and 2002 should be read in conjunction with the
Management's Discussion and Analysis of Financial Condition and Results of
Operations included in our Form S-4 Registration Statement filed with the SEC.
This quarterly report contains forward-looking statements within the meaning of
the "safe harbor" provision of the Private Securities Litigation Reform Act of
1995. All statements in this quarterly report that are not historical facts are
hereby identified as "forward-looking statements" including any statements about
revenue growth, market acceptance of new products, business operations, trends
and changes in financial or operating performance, technology or product
plans.The words "may," "should," "will," "expect," "could," "anticipate,"
"believe," "estimate," "plan," "intend" and similar expressions have been used
to identify certain of the forward-looking statements. These forward-looking
statements are based on management's current expectations, estimates and
projections and they are subject to a number of risks, uncertainties and
assumptions that could cause actual results to differ materially from those
described in the forward-looking statements. These statements are not guarantees
of future performance, involve certain risks, uncertainties, and assumptions
that are difficult to predict, and are based upon assumptions as to future
events that may not prove accurate. Therefore, actual outcomes and results may
differ materially from what is expressed herein.
In any forward-looking statement in which we express an expectation or belief as
to future results, such expectation or belief is expressed in good faith and
believed to have a reasonable basis, but there can be no assurance that the
statement or expectation or belief will result or be achieved or accomplished.
The following important factors are among those that may cause actual results to
differ materially from our forward-looking statements:
o changes in our strategy and business plan, including our plans for the
clinical diagnostics, biodefense, life science and industrial markets
and other healthcare opportunities;
o our ability to develop and introduce new or enhanced products,
including incorporating unit dose cartridges and completion of pending
negotiations for novel centrifuge technologies;
o our ability to enter into new collaborations on favorable terms, if at
all;
o our ability to expand the distribution and increase sales of existing
products;
o the demand for rapid testing products in each of our markets;
o our ability to expand our manufacturing capabilities or find a
suitable manufacturer on acceptable terms or in a timely manner,
including the completion of pending negotiations for contract
manufacturing of one of our instruments;
o our ability to develop our selling, marketing and distribution
capabilities;
20
o our and our licensees' ability to obtain FDA and other governmental
approvals for our and their clinical testing products;
o the ability of our licensees to effectively develop and market
products based on the technology we license to them;
o domestic and foreign governmental and public policy changes,
particularly related to healthcare costs, that may affect new
investments and purchases made by our customers;
o availability of financing and financial resources in the amounts, at
the times and on the terms required to support our future business;
o rapid technological developments in each of our markets and our
ability to respond to those changes in a timely, cost-effective
manner;
o any potential future disputes regarding the scope, permitted use and
other material terms of our license agreements, including those with
Roche and MSD;
o the outcome of the litigation and arbitration between Applied
Biosystems and Roche;
o protection and validity of our patent and other intellectual property
rights;
o statements regarding relationships between us and certain companies
with which we are affiliated; and
o changes in general economic, business and industry conditions.
These forward-looking statements are found at various places throughout this
quarterly report. Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this quarterly
report. We undertake no obligation to publicly update or release any revisions
to these forward-looking statements to reflect events or circumstances after the
date of this quarterly report or to reflect the occurrence of unanticipated
events.
The foregoing list sets forth some, but not all, of the factors that could have
an impact upon our ability to achieve results described in any forward-looking
statements. Investors are cautioned not to place undue reliance on such
statements that speak only as of the date made. Investors also should understand
that it is not possible to predict or identify all such factors and that this
list should not be considered a complete statement of all potential risks and
uncertainties. Investors should also realize that if underlying assumptions
prove inaccurate or unknown risks or uncertainties materialize, actual results
could vary materially from our projections.
As used herein, "BioVeris", "we", "us" and "our" refer to BioVeris Corporation
and its subsidiaries. IGEN refers to IGEN International, Inc. and its
subsidiaries. M-SERIES(R) and TRICORDER(R) are our trademarks. This quarterly
report also contains brand names, trademarks or service marks of other
companies, and these brand names, trademarks or service marks are the property
of those other holders.
21
Overview
We develop, manufacture and market our M-SERIES(R) family of products, which can
serve as a platform for diagnostic systems to be used for the detection and
measurement of biological or chemical substances. We incorporate our
technologies into our instrument systems, tests and reagents, which are the
biological and chemical components used to perform such tests. Using the
M-SERIES platform, we intend to integrate technologies and products to develop
small, expandable and modular systems that can perform a wide variety of
immunodiagnostic and nucleic acid tests.
Our products are designed to be sold in the worldwide diagnostics markets,
including:
o Clinical diagnostics. The clinical diagnostics market includes the
testing of patient samples to measure the presence of disease and
monitor medical conditions. We are developing products to be used in
the clinical diagnostics market and believe that our products are best
suited for the immunodiagnostic and nucleic acid testing market
segments of the clinical testing market.
o Non-clinical diagnostics for the biodefense, life science and
industrial markets. The non-clinical diagnostics market includes
biodefense products for the detection of bacteria, viruses and toxins
that may pose a military or public health threat; life science testing
for drug discovery and development that is performed by pharmaceutical
and biotechnology companies; and industrial testing for the detection
of foodborne and waterborne disease causing pathogens.
We believe that the emergence of simple, more accurate and cost-effective
clinical diagnostic products is shifting the site of clinical diagnostic testing
from clinical reference laboratories and central hospital laboratories to
decentralized patient care centers, such as physicians' offices, ambulatory
clinics, hospital emergency rooms, surgical and intensive care units, hospital
satellite laboratories and nurses' stations, which are collectively referred to
in this quarterly report as clinical point-of-care sites.
Our own product development efforts are focused on M-SERIES instruments and
tests for the clinical diagnostics market, particularly for point-of-care sites.
We are seeking to develop, market and sell products for the clinical
point-of-care market segment through a combination of direct efforts and
collaborative arrangements. We also are pursuing opportunities in the clinical
reference laboratory and central hospital laboratory market segments through
collaborative arrangements.
The M1-M clinical analyzer is the first clinical diagnostic system being
developed by us and builds on the M-SERIES instruments we sell in the biodefense
and life science markets. Our initial commercial focus for the M1-M clinical
analyzer will be to provide cardiac assays that test for heart attack and
congestive heart failure.
22
We are developing the cardiac assays using, among other things, improvements
licensed from an affiliate of Roche. We believe that these improvements will
reduce product development timelines. We also believe that the M1-M clinical
analyzer will provide results to a physician rapidly with the same levels of
sensitivity, accuracy or consistency as a large instrument in a clinical
reference laboratory or in a central laboratory, thereby permitting the
physician to make a more timely decision regarding the patient's course of
treatment. We will seek approval from the FDA for the M1-M clinical analyzer and
other in vitro diagnostics products at the appropriate stage of their product
development.
Our M-SERIES instruments are already being used in biodefense programs for
homeland security, including by the Department of Defense, or DOD. We believe
there will be an increasing opportunity to sell our products for biodefense
tools by governmental and military organizations around the world, as well as in
public health. We are also selling two types of M-SERIES instruments for life
science research to pharmaceutical and biotechnology researchers, as well as to
scientists at academic and government research institutions.
Our assets and businesses have historically been owned and operated by IGEN. Our
financial statements have been prepared and are presented as if we had been
operating as a separate entity using the historical cost basis in the assets and
liabilities of IGEN and including the historical operations of businesses and
assets transferred to us from IGEN as part of the restructuring. Results of
operations in the future are likely to fluctuate substantially from quarter to
quarter as a result of various factors, which include:
o the volume and timing of orders and product deliveries for biodefense
products, M-SERIES systems or other products, which orders and
deliveries are based on our customers' requirements;
o the success of M-SERIES system upgrades and enhancements, which
upgrades and enhancements involve increased product costs at the time
of the upgrade or enhancement, and customer acceptance of those
enhancements and upgrades;
o the amount of revenue recognized from royalties and other contract
revenues, which revenues are dependent upon the efforts of our
licensees and collaborators;
o whether our instruments are sold or leased to customers, which will
affect the timing of the recognition of revenue from the sale or
lease;
o the timing of our introduction of new products, which could involve
increased expenses associated with product development and marketing;
o the volume and timing of product returns and warranty claims, which,
if products are returned or have warranty claims that are unexpected,
may involve increased costs in excess of amounts reserved for returns
or claims;
23
o our competitors' introduction of new products, which may affect the
purchase decision of or timing of orders by our customers and
prospective customers while the competitors' product is assessed;
o the amount of expenses we incur in connection with the operation of
our business, including:
o research and development costs, which increases or decreases
based on the product in development and
o sales and marketing costs, which are based on product launches or
promotions and sales incentives that might be in effect from time
to time;
o the amount that we will record each quarter related to the
amortization or impairment of the license to use PCR technology, which
may increase based on the outcome of the litigation and arbitration
commenced against Roche by Applied Biosystems relating to Roche's and
Applied Biosystems' respective rights to PCR technology;
o unexpected termination of government contracts or orders, which could
result in decreased sales and increased costs due to excess capacity,
inventory personnel and other expenses; and
o our share of losses in MSD, which are based on results of MSD's
operations, which for the three and nine months ended December 31,
2003 totaled $3.7 million and $13.4 million, respectively, compared to
$3.3 million and $12.8 million for the three and nine months ended
December 31, 2002.
o additional costs which we may incur as we explore new health care
opportunities, including costs for acquisitions of technologies,
facilities and personnel.
We expect to incur additional operating losses as a result of our expenses for
manufacturing, marketing and sales capabilities, research and product
development, general and administrative costs, the expenses of the MSD joint
venture and a compensation charge associated with the cancellation of IGEN stock
options in connection with the merger. Our net loss is expected to increase in
the three months ended March 31, 2004 as a result of our recognition of an
allocated noncash compensation charge associated with the cancellation of IGEN
stock options and the payment of the merger consideration for each share covered
by IGEN stock options in connection with the merger.
Our ability to become profitable in the future will be affected by, among other
things, our ability to expand the distribution and increase sales of existing
products, upgrade and enhance the M-SERIES family of products, introduce new
products into the market, generate higher revenue, develop marketing, sales and
distribution capabilities cost-effectively, and continue collaborations
established by IGEN or establish successful new collaborations with corporate
partners to develop, manufacture, market and sell products that incorporate our
technologies.
For a description of our business, you should refer to the Form S-4
Registration Statement filed with the SEC.
24
Results of Operations
Quarter and Nine Months Ended December 31, 2003 and 2002
Revenues. Total revenues were $3.8 million and $14.8 million for the quarter and
nine months ended December 31, 2003, respectively, a decrease of $1.7 million
and an increase of $1.7 million, respectively, from $5.5 million and $13.1
million for the corresponding prior year periods. Product sales were $3.5
million and $13.9 million for the quarter and nine months ended December 31,
2003, respectively, a decrease of $1.7 million (32%) and an increase of $1.8
million (15%), respectively, from $5.2 million and $12.1 million for the
corresponding prior year periods. The decrease in product sales during the
quarter ended December 31, 2003 resulted from sales of products for the life
science market of $2.7 million, a decrease of $500,000 from $3.2 million for the
quarter ended December 31, 2002, and sales of biodefense products of $800,000, a
decrease of $1.2 million from $2.0 million for the quarter ended December 31,
2002. The increase in product sales during the nine months ended December 31,
2003 resulted from sales of products for the life science market of $9.6
million, an increase of $700,000 from $8.9 million for the nine months ended
December 31, 2002, and sales of biodefense products of $4.3 million, an increase
of $1.1 million from $3.2 million for the nine months ended December 31, 2002.
These changes in product sales during the three and nine months ended December
31, 2003 from 2002 reflect the periodic changes in volume and timing of orders
and product deliveries for biodefense products and M-SERIES systems, which
orders and deliveries are based on our customers' requirements.
We anticipate increases in biodefense-related sales as a result of our ongoing
biodefense initiatives. As part of the merger and related transactions, we
assumed a contract between IGEN and the DOD pursuant to which the DOD may
purchase tests for the detection of specific toxins in environmental samples
from IGEN. Under the contract, the DOD may, at its option, make purchases of up
to $23.0 million over a period of up to 48 months. As of December 31, 2003, the
DOD had purchased approximately $2.1 million of products and, under the
contract, may purchase up to a maximum of $7.0 million in the 12-month period
ending June 2004. Sales of our products for the life science market are subject
to a number of uncertainties, including the fact that we are not a party to
significant long-term contracts for the sale of our products for the life
science market that would provide predictable sales. Therefore, the volume and
timing of product orders from our life science customers are based on their
requirements, which may vary over time. As a result, we believe that we do not
have sufficient information to reasonably project our future sales in the life
science market.
Operating Costs and Expenses. Product costs were $3.3 million (93% of product
sales) and $9.0 million (65% of product sales) for the quarter and nine months
ended December 31, 2003, and $2.4 million (47% of product sales) and $5.4
million (44% of product sales) for the corresponding prior year periods. Product
costs, as a percentage of product sales, increased due to costs incurred in
connection with instrument upgrades (16% and 6% of product sales for the three
and nine months ended December 31, 2003, respectively) and detection module
upgrades (34% and 17% of product sales for the three and nine months ended
December 31, 2003, respectively) for existing life science customers. Instrument
upgrade costs as a percentage of sales were 9% and 6%, respectively for the
three and nine months ended December 31, 2002.
25
These voluntary upgrades were provided to enhance overall customer satisfaction.
The instrument and detection module upgrade programs have been substantially
completed as of December 31, 2003. Our future product costs are subject to a
number of uncertainties relating to, among other things, the launch of new
instrument systems.
Research and development expenses were $4.3 million and $14.6 million for the
quarter and nine months ended December 31, 2003, respectively, a decrease of
$1.2 million (21%) and $2.8 million (16%), respectively, from $5.5 million and
$17.4 million for the corresponding prior year periods. These decreases were due
primarily to lower personnel and facilities costs for development projects.
Research and development expenses primarily relate to ongoing development costs
and product enhancements associated with the M-SERIES family of products,
development of new assays and research and development of new systems and
technologies, including point-of-care products. We expect research and
development costs to increase as product development and core research expand,
including costs associated with our efforts in developing clinical diagnostics
and biodefense testing products, and as we explore other opportunities in the
healthcare field.
Selling, general and administrative expenses were $4.6 million and $13.7 million
for the quarter and nine months ended December 31, 2003, respectively, a
decrease of $1.0 million (17%) and $2.1 million (14%), respectively, from $5.6
million and $15.8 million for the corresponding prior year periods. These
decreases were primarily attributable to lower personnel costs in the current
year periods. For each of the periods, we were fully integrated with IGEN and
the accompanying condensed consolidated financial statements reflect the
application of certain estimates and allocations. Our condensed consolidated
statements of operations include all revenues and costs that are directly
attributable to our businesses. In addition, certain expenses of IGEN have been
allocated to us using various assumptions that, in the opinion of management,
are reasonable. These expenses include an allocated share of general and
administrative salaries as well as certain other shared costs (primarily
facility, human resources, legal, accounting and other administrative costs)
which were allocated based upon percentage of total revenue or percentage of
total headcount, as appropriate. These allocated expenses comprise substantially
all of our selling, general and administrative expenses for the three and nine
months ended December 31, 2003.
We have incurred merger related costs in connection with the Roche merger and
related transactions, including the restructuring and the distribution of our
shares by IGEN, which include primarily accounting, legal, printing and
registration fees, as well as the allocation of a noncash compensation charge
associated with the accelerated vesting of certain employee stock options
pursuant to the restructuring. These merger related costs were $3.9 million and
$4.1 million for the quarter and nine months ended December 31, 2003, including
$2.5 million associated with the noncash compensation charge. We will incur
additional merger related costs through the February 13, 2004 closing of the
merger and related transactions.
Interest Expense and Other. Interest expense, net of other income, was income of
$125,000 and $173,000 for the quarter and nine months ended December 31, 2003,
respectively.
Equity in Loss of Joint Venture. MSD is a joint venture formed by MST and IGEN
in 1995. MSD was formed for the development, manufacture, marketing and sale of
products utilizing a proprietary combination of MST's multi-array technology
together with our ECL technology.
26
We have recorded our proportionate share of MSD losses, representing
approximately 100% of MSD's losses, for the three and nine months ended December
31, 2003 and 2002. As part of the merger and related transactions, IGEN
transferred its interest in MSD to us. Equity in loss of joint venture was $3.7
million and $13.4 million for the three and nine months ended December 31, 2003,
and $3.3 million and $12.8 million for the three and nine months ended December
31, 2002, respectively.
MSD's losses increased in fiscal 2004 primarily due to higher costs associated
with its transition from a development stage entity to a commercial operating
company. The increase in MSD's losses during the three and nine months ended
December 31, 2003 results primarily from increases in sales and marketing
expenses which were offset only in part by the growth in revenues which
commenced in October 2002.
MSD manufactures, markets and sells instrument systems, including the Sector HTS
and the Sector PR, which combine MST's multi-array technology and ECL
technology. The Sector HTS is an ultra high throughput drug discovery system
engineered for applications such as high throughput screening and large-scale
proteomics. The Sector PR is a smaller system designed for bench-top
applications such as assay development, research in therapeutic areas, cellular
biology and medium throughput screening. MSD also manufactures and markets its
own line of reagents, assays and plates that are used on these systems.
As of December 31, 2003, MSD had cash and short-term investments of $4.4 million
with working capital of $9.7 million. During the nine months ended December 31,
2003, MSD used $3.1 million for the purchase of inventory and $1.7 million for
the purchase of property, equipment and leasehold improvements. See "Liquidity
and Capital Resources" for a discussion of our funding commitments to MSD.
Net Loss. The net loss was $16.0 million and $39.8 million for the quarter and
nine months ended December 31, 2003, respectively, compared to a net loss of
$11.3 million and $38.2 million for the quarter and nine months ended December
31, 2002, respectively. The increased net loss in the current periods is
primarily due to merger related costs.
Our net loss will increase during the three months ended March 31, 2004 due to
additional merger related costs incurred through the February 13, 2004 closing
of the merger and related transactions. Merger related costs will include our
recognition of an allocated one-time noncash compensation charge of
approximately $37 million associated with the cancellation of IGEN stock options
and the payment of the merger consideration for each share covered by IGEN stock
options in connection with the merger. See Note 4 to Condensed Consolidated
Financial Statements.
Liquidity and Capital Resources
In connection with the merger and related transactions, Roche loaned IGEN
approximately $210 million. These funds, less transaction costs of
approximately $25 million, were contributed by IGEN to us as part of the
restructuring. The related promissory note remained the obligation of IGEN and
we have no obligations associated with that debt.
27
After the PCR license payment of $50 million to certain affiliates of Roche and
the final capital contribution of $37.5 million, as adjusted, (of which any
amount in excess of $30 million will be funded by Mr. Samuel Wohlstadter,
BioVeris's chairman and chief executive officer through the purchase of shares
of BioVeris series B preferred stock that economically mirror the class C
interests in MSD to be held by BioVeris) to MSD, we commenced operations
following completion of the merger with approximately $145 million in cash.
IGEN has historically held all cash in a centralized treasury and has provided
all of the necessary funding for our operations since inception. Accordingly, as
of December 31, 2003, we had no cash, cash equivalents or short-term
investments.
Net cash used for operating activities was $19.8 million and $24.0 million, for
the nine months ended December 31, 2003 and 2002, respectively. These changes
between periods are primarily due to the size of each period's operating loss
and changes in working capital accounts.
We used cash of $1.4 million and $2.6 million during the nine months ended
December 31, 2003 and 2002, respectively for the acquisition of equipment and
leasehold improvements. Our investments in MSD totaled $20.9 million and $16.9
million for the nine months ended December 31, 2003 and 2002, respectively.
The tax allocation agreement provides that Roche and IGEN will be solely liable
for, will jointly and severally indemnify us against, and will be entitled to
receive and retain all refunds of, taxes (other than transfer taxes) directly or
indirectly resulting from, arising in connection with or otherwise related to
the merger and related transactions, any transaction undertaken to prepare for
the merger and related transactions and any of the actions taken pursuant to the
ongoing litigation agreement. This agreement also provides for us to make a
payment to IGEN of up to $20 million within 10 days of receiving notice from
Roche. The amount of the payment will depend on the average of the high and the
low trading prices of our common stock on the first day of trading after the
completion of the merger. A payment will be due if such average is at least
approximately $13.09 per share and the maximum payment will be due if such
average exceeds approximately $14.96, in each case based on the assumption that
we will have $225 million in cash and cash equivalents immediately after
completion of the merger and prior to making any payments due pursuant to the
related transaction agreements, the ongoing commercial agreements or the MSD
letter agreement.
We believe that material commitments for capital expenditures and additional or
expanded facilities may be required in a variety of areas, such as product
development programs. We are evaluating new facilities for development,
manufacturing and other corporate uses and are negotiating to secure new space,
which if concluded, would result in additional facilities costs. We have not, at
this time, made material commitments for any such capital expenditures or
facilities and have not secured additional sources, if necessary, to fund such
commitments.
Net cash provided by financing activities was $42.1 million and $43.5 million,
for the nine months ended December 31, 2003 and 2002, respectively. These
amounts in each respective period primarily represent the cash contributed, net
of receipts, by IGEN to us.
28
As of December 31, 2003, our material future obligations were as follows:
Three Months
Ended
March 31, 2009 and
Contractual Obligations Total 2004 2005 2006 2007 2008 Thereafter
- ----------------------- -------------------------------------------------------------------------------------
(In thousands)
PCR license fee $ 50,000 $ 50,000 $ - $ - $ - $ - $ -
MSD funding commitment(1) 35,720 35,720 - - - - -
Operating leases(2) 19,847 650(2) 3,181 3,164 3,241 3,338 6,273
-------- -------- -------- -------- -------- -------- --------
Total contractual obligations $105,567 $ 86,370 $ 3,181 $ 3,164 $ 3,241 $ 3,338 $ 6,273
======== ======== ======== ======== ======== ======== ========
(1) Includes a final capital contribution of $37.5 million to MSD from us
following the completion of the merger, of which any amount in excess
of $30 million will be funded by our chairman and chief executive
officer through the purchase of shares of our series B preferred stock
that economically mirror the class C interest in MSD to be held by us,
less interim funding of $1.8 million to MSD for the month of December
2003 which has been paid pursuant to an agreement by which 1/12th of
IGEN's aggregate funding commitment under the MSD budget for 2003,
would be payable monthly commencing on December 1, 2003 until the
completion of the merger. Excludes up to $4.6 million that MSD has
asserted we may be obligated to pay MSD under the approved 2003
funding which we do not believe is required by the agreements between
MSD and us.
(2) Excludes $94,000 with respect to operating leases that will be
allocated to MSD through the closing date of the merger and related
transactions. These amounts are included in the MSD funding commitment
amount in the line immediately above.
Following the completion of the merger, and after paying certain obligations
including the PCR license fee and satisfying the MSD funding commitment
described below, we expect to commence operations with approximately $145
million in cash.
After completion of the merger and related transactions, we will pay certain
affiliates of Roche a fee of $50 million for a worldwide, non-exclusive license
under patents that cover certain PCR inventions in accordance with the PCR
product license agreement. We will owe royalties on sales of the licensed
products and on sales of any instrument, accessory, device or system sold for
use with the licensed products and on the performance of licensed tests. We will
amortize the license fee over an estimated useful life of 10 years based upon a
consideration of the range of patent lives and the weighted average remaining
life of the most important underlying patents as well as a consideration of
technological obsolescence and product life cycles. We do not currently sell, or
have under development, any product based on the PCR technology being licensed
from Roche.
29
MSD is a joint venture formed by MST and IGEN in 1995. As part of the merger and
related transactions, IGEN's equity interest in the MSD joint venture has been
transferred to us. Under the MSD agreements, IGEN's funding commitment was based
on an annual budget of MSD approved by the JVOC. IGEN's funding commitment was
satisfied in part through in-kind contributions of scientific and administrative
personnel and shared facilities. In accordance with the MSD joint venture
agreement, the value of these in-kind contributions is based upon costs incurred
by us as determined through allocation methods that include time-spent and
square footage utilized. During the nine months ended December 31, 2003 and
2002, operating costs allocated to MSD by us in connection with shared personnel
and facilities totaled $5.7 million and $8.3 million, respectively.
The JVOC approved funding for MSD for the period from January 1, 2003 to
November 30, 2003 in an amount of $20.6 million, subject to a permitted variance
of 15%, of which approximately $19.1 million was spent by MSD and funded by us.
MSD has asserted may be obligated to pay MSD up to $4.6 million for additional
budgeted amounts up to the $20.6 million approved funding plus the permitted
variance and we do not believe this payment is required by the agreements
between MSD and us. Upon the completion of the merger, the MSD joint venture
agreement expired and we will make a final capital contribution of $37.5 million
to MSD. Our obligation to make the final contribution to MSD was separate from
our obligation to provide funding to MSD through November 30, 2003. Of the final
capital contribution of $37.5 million, any amount in excess of $30 million
(including any interim funding provided by IGEN as described below) will be
funded by our chairman and chief executive officer through the purchase of
shares of our series B preferred stock that economically mirror the class C
interest in MSD to be held by us. Under the terms of the series B preferred
stock, we may redeem the series B preferred stock for $0.01 per share at any
time we are no longer entitled to receive distributions with respect to the
class C interests described in the previous sentence pursuant to the MSD limited
liability company agreement. We will redeem a proportionate part of the series B
preferred stock in connection with any redemption by MSD of the class C
interests held by us in MSD described in the previous sentence. No distributions
on the series B preferred stock will be paid unless and until distributions are
paid on such class C interests in accordance with the MSD limited liability
company agreement, in which event distributions on the series B preferred stock
will be paid in the same manner and amount as such distributions on the class C
interests. The shares of our series B preferred stock are entitled in the
aggregate to 1,000 votes on all matters on which holders of our common stock may
vote. In addition, we may not consent to any adverse change to the terms of the
class C interests in MSD described in this paragraph without the consent of the
holders of the series B preferred stock.
As the merger was not completed prior to December 1, 2003, IGEN agreed to
provide continued interim funding to MSD, payable monthly on the first day of
each month commencing on December 1, 2003 until the completion of the merger.
The monthly funding was equal to approximately $1.7 million, which is 1/12th of
IGEN's aggregate funding commitment under the MSD budget for 2003 approved by
the JVOC. Such interim funding, which totaled $5.2 million from December 1, 2003
through February 1, 2004, will reduce the amount of the Company's final capital
contribution to $32.3 million, of which $7.5 million will be funded by our
chairman and chief executive officer through the purchase of shares of our
series B preferred stock that economically mirror the class C interest in MSD to
be held by us. For the nine months ended December 31, 2003 and 2002, total
contributions to MSD were $20.9 million and $16.9 million, respectively,
including $3.7 million in the nine months ended December 31, 2003, which related
to the permitted budget variances from prior years.
30
IGEN, BioVeris and MSD agreed that the MSD joint venture agreement expired upon
completion of the merger and related transactions. As a result, MSD and MST have
the right to purchase for a purchase price equal to fair market value (to be
determined in accordance with the provisions and procedures set forth in the MSD
agreements, which will include a determination by appraisers if the parties are
unable to agree on fair market value), less a 7.5% discount factor, our entire
interest in MSD, including our preferred interests that entitle us to a
preferred return on our investment in MSD. If MSD or MST exercises this right,
it will be required to pay us the outstanding purchase price plus simple
(cumulated, not compounded) interest at the fixed annual rate of 0.5% over the
prime rate in effect on the date that MSD or MST, as the case may be, elects to
purchase the interests. The purchase price is payable over time in installments
equal to the sum of 5% of MSD net sales, as determined in accordance with MSD
agreements, and 20% of the net proceeds realized by MSD from the sale of its
debt or equity securities in any third-party financing after the date of the
sale of our interest in MSD. In the event such future net sales or third-party
financings do not materialize, we will not receive any payments from MSD or MST,
as the case may be, for the purchase of our interest in MSD. As security for the
payment obligation we will hold a security interest in the interests in MSD that
are being purchased. MST or MSD, as the case may be, may repay all or any part
of the outstanding purchase price plus accrued interest at any time and from
time to time without penalty.
Following the expiration of the MSD joint venture agreement, many of the
licenses and other arrangements with MSD and MST assigned to us continued
indefinitely in accordance with their terms. These include:
o the IGEN/MSD license agreement, pursuant to which we granted to MSD a
worldwide, perpetual, exclusive license (with certain exceptions) to
our technology, including ECL technology, for use in MSD's research
program, defined in the MSD agreements; and
o the MSD/MST sublicense agreement (but only as to IGEN or our
technology or improvements developed before IGEN or us ceases to be a
member of MSD), pursuant to which MST was granted a worldwide,
perpetual, non-exclusive sublicense to use our technology to make, use
or sell products or processes applying or related to the technologies
used in the MSD research program outside the diagnostic field.
In addition, certain of our obligations under the MSD joint venture agreement
survived its termination, including:
o to cooperate and work in good faith and use reasonable best efforts to
assist MSD in securing third-party financing;
o confidentiality obligations;
o to make available to MSD the benefits of certain agreements with
third-party licensors, suppliers, vendors, distributors and other
providers;
31
o to assign to MSD all proprietary information and intellectual property
within the MSD research program or research technologies, as described
in the MSD agreements, and to ensure that its employees protect such
proprietary information;
o to defend and indemnify MSD against all claims arising out of the
conduct of the MSD research program and to maintain liability
insurance to cover the risk of liability resulting from the conduct of
that program; and
o unless MSD or MST exercises its right to purchase our interests in
MSD, not to vote against or refuse to consent to, agree to or approve
any action supported by MST unless a committee of our board of
directors reasonably concludes, after having considered the interests
of MSD, that the action is not in the best interests of us and our
stockholders.
Notwithstanding expiration of the MSD joint venture agreement, we are required
to continue to pay the expenses associated with prosecuting and maintaining the
patents licensed by MST to MSD in connection with the original formation of the
MSD joint venture unless and until MSD or MST exercises its right to purchase
our interests in MSD.
Following the expiration of the MSD joint venture agreement, MSD is entitled to
continue to lease certain facilities and related equipment from us (including
laboratory facilities located in our corporate headquarters) pursuant to the
terms of the existing sublease agreements with MSD. The term of each sublease
will expire one day prior to the expiration of the prime lease for that
facility. Each sublease agreement provides that, subject to certain exceptions,
we must exercise all available extension rights under the prime lease. Following
expiration of the MSD joint venture agreement, each of MSD and BioVeris may
unilaterally terminate any or all of the subleases by providing at least 18
months prior written notice of termination. If we elect to terminate a sublease
for a facility, MSD may elect, notwithstanding any termination of the sublease,
to remain in the subleased facility after the 18-month period expires for any
period of time selected by MSD, but not longer than one day prior to the
expiration of the prime lease (including any extensions of the prime lease).
After a notice of termination of a sublease has been sent, MSD will be required
to pay its pro rata share of all rental and other expenses incurred by us under
the prime lease. MSD and MST may elect, if either exercises its right to
purchase our interests in MSD, to have its rental and expense payment
obligations for the 18-month period included in the purchase price of those
interests in MSD.
MSD has an employment agreement with Mr. Jacob Wohlstadter, its president and
chief executive officer, the current term of which runs through November 30,
2004. The term of the employment agreement will automatically renew for a
12-month period on November 30 of each year unless either MSD or Mr. Jacob
Wohlstadter gives notice of termination no later than 180 days prior to that
renewal date. That employment agreement provides for a salary at the annual rate
of $250,000 through November 30, 2003. Thereafter, the salary is to be increased
as agreed to by MSD and Mr. Jacob Wohlstadter. In addition, Mr. Jacob
Wohlstadter is also eligible to receive, at the discretion of the JVOC of our
board of directors, an annual cash bonus in an amount not to exceed 20% of his
annual salary. Mr. Jacob Wohlstadter is also entitled to receive pension,
welfare and fringe benefits comparable to those received by our senior
executives and other insurance benefits.
32
If MSD terminates the employment agreement without cause, or Mr. Jacob
Wohlstadter terminates the employment agreement for good reason (which includes
a "change in control" of BioVeris, as defined), Mr. Jacob Wohlstadter will be
entitled to receive, in addition to salary and pro rata bonus and adjustments
earned through the 60th day following the notice of termination, an amount equal
to from 3 to 12 times (depending on the reason for the termination) the monthly
pro rata salary, bonus and adjustments in effect at the time of the termination.
Under the employment agreement, Mr. Jacob Wohlstadter is also entitled to
receive a gross-up for any "parachute" excise tax that may be imposed on
payments made or benefits provided pursuant to the agreement. Upon completion of
the merger, we are obligated to maintain in effect directors and officers
liability insurance coverage for Mr. Jacob Wohlstadter and to pay Mr. Jacob
Wohlstadter the applicable salary, pro rata bonus and adjustments in effect at
the time of termination as described above and a gross-up for any "parachute"
excise tax that may be imposed. MSD and Mr. Jacob Wohlstadter have each agreed
that the merger and related transactions will not constitute a change in control
for purposes of the MSD agreements and the employment agreement. We will also
indemnify Mr. Jacob Wohlstadter against certain liabilities, including liability
from the MSD joint venture relating to the period of IGEN's or our involvement
with MSD. In addition, we will be obligated under the MSD agreements to
indemnify each board member or officer of MSD with respect to any action taken
by such person prior to the termination of the MSD joint venture agreement by
reason of the fact that such person is or was a board member or an officer of
MSD. With respect to such indemnification obligations, there are no pending or
known matters covered by these indemnification provisions that would have a
material effect on our financial position or results of operations.
Mr. Jacob Wohlstadter has a consulting agreement with IGEN that was assumed by
us. This consulting agreement will be automatically renewed on August 15, 2004,
for a period of three years unless either us or Mr. Jacob Wohlstadter gives
notice to the contrary no later than 90 days before that date. Pursuant to the
consulting agreement, Mr. Jacob Wohlstadter will be entitled to receive such
fees as we and Mr. Jacob Wohlstadter agree to when consulting services are
requested by us. We have no obligation to request any consulting services from
Mr. Jacob Wohlstadter. Mr. Jacob Wohlstadter did not perform any compensable
consulting services during the nine months ended December 31, 2003 and 2002.
Mr. Jacob Wohlstadter and JW Consulting Services, L.L.C., a company established
and wholly-owned by Mr. Jacob Wohlstadter, have an indemnification agreement
with IGEN that we assumed. Pursuant to the indemnification agreement, we will
indemnify Mr. Jacob Wohlstadter and JW Consulting Services, L.L.C. against any
claims arising out of the performance or non-performance of services to or for
the benefit of us.
Product development for our clinical diagnostic products is at an early
development stage and products based on the PCR technology being licensed from
Roche are not yet under development. Product development is subject to a number
of technical and commercial uncertainties and in part depends upon our ability
to enter into new collaborative arrangements. Accordingly, we have not yet
completed a business plan for our clinical diagnostic products, including
immunodiagnostic and PCR technology-based products, do not have definitive
product introduction timelines or budgets and have not determined the additional
funding, personnel, facilities, equipment or technology that may be required to
implement our plans.
33
Our ability to become profitable in the future will depend on, among other
things, the introduction of new products to the market. If we are unable to
develop new products, including products based on PCR technology, our business
prospects and financial results would be adversely affected.
Furthermore, we will need substantial amounts of money to fund our operations on
an ongoing basis. We expect our available cash to be sufficient to fund our
operations for at least one year, but we cannot predict how long our available
cash will be sufficient to fund our operations thereafter. In this regard, we
expect that we will from time to time have discussions with third parties,
including multinational corporations, regarding various business arrangements
including distribution, marketing, research and development, joint venture and
other business agreements, which could provide for substantial up-front fees or
payments. We cannot assure you that we will successfully complete any of the
foregoing arrangements and access to funds could be adversely impacted by many
factors, including the volatility of the price of our common stock, continuing
losses from our operations, establishment of new business arrangements, the
status of new product launches, general market conditions and other factors.
If we are unable to raise additional capital, we may have to scale back, or even
eliminate, some programs. Alternatively, we may consider pursuing arrangements
with other companies, such as granting licenses or entering into joint ventures
or collaborations, on terms that may not be favorable to us.
As of December 31, 2003, we had no off-balance sheet arrangements.
CRITICAL ACCOUNTING POLICIES
A critical accounting policy is one that is both important to the portrayal of
our financial position and results of operations and requires the application of
difficult, subjective or complex judgments by management. As a result, critical
accounting policies are subject to an inherent degree of uncertainty. In
applying those policies, management uses its judgment to determine the
appropriate assumptions to be used in the determination of certain estimates.
These estimates are based on our management's experience, terms of existing
contracts, observance of trends in the industry, information provided by
customers, and information available from other outside sources, as appropriate.
Our critical accounting polices include:
Expense Allocations -- Our assets and businesses have historically been owned,
operated and fully integrated with IGEN. Our financial statements have been
prepared and are presented as if we had been operating as a separate entity. In
order to fairly present our operating results, these financial statements
reflect the application of certain estimates and allocations. Our condensed
consolidated statements of operations include all costs that are directly
attributable to our businesses, as well as certain expenses of IGEN that have
been allocated to us using various assumptions. These expenses include an
allocated share of general and administrative salaries as well as certain other
shared costs (primarily facility, human resources, legal, accounting and other
administrative costs) which were allocated based upon percentage of total
revenue or percentage of total headcount, as appropriate. While management
believes that the allocation methodologies are reasonable and appropriate,
different allocation methodologies could result in changes to our operating
results.
34
Revenue Recognition -- We derive revenue principally from three sources: product
sales, royalty income and contract fees. Product sales revenue is generally
recognized when persuasive evidence of an arrangement exists, the price to the
buyer is fixed and determinable, collectibility is reasonably assured and the
product is shipped to the customers thereby transferring title and risk of loss.
For instrument sales, the instrument and the related installation are considered
to be separate elements under EITF 00-21. Revenue is recognized for the
instrument upon shipment and is recognized for the installation when complete
based upon the residual value method. For instrument and reagent sales, there is
no option of return and refund, only the option to repair or replace. Other than
the installation required for the instruments, there are no contingencies,
allowances or other post-sale obligations. For instrument leases, the instrument
rental and related minimum reagent purchases are considered to be separate
elements under EITF 00-21 and, accordingly, the sales price is allocated to the
two elements based upon their relative fair values. Instrument rental revenue is
recognized ratably over the life of the lease agreements and the related reagent
revenue is recognized upon shipment. Revenue associated with extended warranty
arrangements is recognized over the term of the extended warranty contract.
Royalty income is recorded when earned, based on information provided by
licensees. Revenue from services performed under contracts is recognized when
obligations under the contract have been satisfied. The satisfaction of
obligations may occur over the term of the underlying customer contract, if the
contract is based on the achievement of certain "milestones," or may occur at
the end of the underlying customer contract, if based only upon delivery of the
final work product.
The majority of our product sales and contract fees contain standard terms and
conditions. Certain transactions may contain negotiated terms that require
contract interpretation to determine the appropriate amount of revenue to be
recognized. In addition, we must assess whether collectibility is reasonably
assured. While we believe our interpretations and judgments are reasonable,
different assumptions could result in changes in the timing of revenue
recognition.
Joint Venture Accounting -- We account for our ownership in the MSD joint
venture on the equity method as we have determined that we do not control MSD's
operations. Factors considered in determining our level of control include the
fact that we have less than 50% of the voting equity interest in MSD; that we do
not have exclusive authority over MSD decision making and have no ability to
unilaterally modify the joint venture agreements; and that we have the right to
appoint only one out of two seats on MSD's board of managers. A different
assessment of these factors could provide for the use of consolidation
accounting rather than the equity method, in which case a consolidation of our
financial statements with those of MSD would be appropriate. Consolidation
accounting would require certain reclassifications within our consolidated
financial statements but would not materially affect our financial position or
net loss.
In January 2003, the FASB issued Interpretation No. 46, "Consolidation of
Variable Interest Entities," or FIN 46. FIN 46 provides guidance on variable
interest entities such as the MSD joint venture and the framework through which
an enterprise assesses consolidation of a variable interest entity. We will
adopt FIN 46 as of January 1, 2004. See Recent Accounting Pronouncements for
discussion of consolidation accounting for the investment in joint venture
beginning January 1, 2004.
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Allowance for Doubtful Accounts -- We maintain reserves on customer accounts
where estimated losses may result from the inability of our customers to make
required payments. These reserves are determined based on a number of factors,
including the current financial condition of specific customers, the age of
accounts receivable balances and historical loss rates. If the financial
condition of our customers were to deteriorate, resulting in an impairment of
their ability to make payments, an additional allowance may be required.
Inventory -- We record our inventory at the lower of cost or market using the
first-in, first-out method. We regularly review inventory quantities on hand and
record a reserve for excess and obsolete inventory based primarily on an
estimated forecast of product demand and production requirements for the next 12
months. Reserves are recorded for the difference between the cost and market
value. Those reserves are based on significant estimates. Our estimates of
future product demand may prove to be inaccurate, in which case we may have
understated or overstated the provision required for excess and obsolete
inventory. In addition, our industry is characterized by technological change,
frequent new product development and product obsolescence that could result in
an increase in the amount of obsolete inventory quantities on hand. Although we
make every effort to ensure the accuracy of our forecasts of future product
demand, any significant unanticipated changes in demand or technological
developments could have a significant impact on the values of our inventory and
our reported operating results.
Evaluation of Long-Lived Assets --We have different long-lived assets recorded
on our balance sheet that include equipment and leasehold improvements,
investments and other assets. We evaluate the potential impairment of long-lived
assets whenever events or changes in circumstances indicate that the carrying
amount of an asset may not be fully recoverable. In evaluating the
recoverability of an asset, our policy is to compare the carrying amount of an
asset with the projected undiscounted cash flow. While we believe that our
projections are reasonable and that no impairment of these assets exists,
different assumptions could affect these evaluations and result in impairment
charges against the carrying value of these assets.
Warranty Reserve -- We warrant our products against defects in material and
workmanship for one year after sale and record estimated future warranty costs
at the time revenue is recognized. A reserve for future warranty claims is
recorded based upon our review of historical results, supplemented by
expectations of future costs. Unanticipated changes in actual warranty costs
could impact our operating results.
Capitalized Software Costs -- We record software development costs in accordance
with SFAS No. 86, "Accounting for the Costs of Computer Software to be Sold,
Leased, or Otherwise Marketed." We apply our judgment in determining when
software being developed has reached technological feasibility, and at that
point we would capitalize software development costs. To date, software
development has been substantially completed concurrently with the establishment
of technological feasibility, and accordingly, no costs have been capitalized to
date.
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RECENT ACCOUNTING PRONOUNCEMENTS
In December 2002, the FASB issued SFAS No. 148, "Accounting for Stock-Based
Compensation -- Transition and Disclosure -- an amendment of SFAS No. 123," or
SFAS 148. SFAS 148 amends SFAS 123, "Accounting for Stock-Based Compensation,"
or SFAS 123, to provide alternative methods of voluntarily transitioning to the
fair value based method of accounting for stock-based employee compensation.
SFAS 148 also amends the disclosure requirements of SFAS 123 to require
disclosure of the method used to account for stock-based employee compensation
and the effect of the method on reported results in both annual and interim
financial statements. This pronouncement is effective for both annual and
interim periods beginning after December 15, 2002. We have elected to follow the
recognition and measurement principles of Accounting Principles Board Opinion
No. 25, "Accounting for Stock Issued to Employees," in our accounting for
employee stock options. In accordance with SFAS 148, we have adopted the annual
and interim period disclosure requirements.
In January 2003, the FASB issued Interpretation No. 46, "Consolidation of
Variable Interest Entities," or FIN 46. FIN 46 provides guidance on variable
interest entities such as the MSD joint venture and the framework through which
an enterprise assesses consolidation of a variable interest entity. We will
adopt FIN 46 as of January 1, 2004 and have determined that MSD qualifies as a
variable interest entity based upon the following rationale:
o We have provided substantially all of MSD's funding since inception
through capital contributions consisting of class B and C non-voting
equity interests. Such funding is not considered "at risk" as the
investments do not participate significantly in the profits of MSD
given their stated return rates. As such, the "at risk" equity of MSD
is insufficient to absorb MSD's expected future losses.
o We hold 31% of the voting rights in MSD while providing 100% of MSD' s
funding, and we are thereby considered to be involved in all of MSD's
activities as defined under FIN 46.
As the merger and related transactions do not change the design of or ownership
interests in MSD in such a manner that could affect the status of MSD as a
variable interest entity or us as the primary beneficiary, we do not believe
they are deemed to be events that would require reassessment of our previous
conclusion that MSD qualifies as a variable interest entity under FIN 46 with us
as the primary beneficiary.
Accordingly, beginning January 1, 2004 and continuing subsequent to the
completion of the merger and related transactions, we will consolidate the
financial results of MSD. Under the transition guidance of FIN 46 because MSD
was created before February 1, 2003, we will measure the assets, liabilities and
noncontrolling interests of MSD as of January 1, 2004 for purposes of the
initial consolidation. The amounts of the assets, liabilities and noncontrolling
interests will be reflective of their respective carrying amounts had FIN 46
been effective when we first met the conditions to be the primary beneficiary of
MSD upon MSD's inception in 1995. Such carrying amounts are expected to equal
MSD's recorded values, which as of December 31, 2003, were approximately $18.8
million, $1.7 million and $10,000, respectively.
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As we have historically recorded and will continue to record approximately 100%
of MSD's losses, it is anticipated that upon implementation of FIN 46, the
consolidated net assets of MSD will approximate the book value of our investment
in joint venture. As such, consolidation accounting will require certain
reclassifications within our consolidated financial statements, but it is not
expected to materially affect our financial position or net loss. The required
balance sheet reclassifications will reclassify the amounts formerly recorded on
a "net" basis as investment in joint venture to be reflected on a "gross" basis
primarily as cash, accounts receivable, inventory, fixed assets, accounts
payable and accrued expenses. The required statement of operations
reclassifications will reclassify the amounts formerly recorded on a "net" basis
as equity in loss of joint venture to be reflected on a "gross" basis primarily
as revenue, product costs, research and development expenses and selling,
general and administrative expenses.
In April 2003, the FASB issued SFAS No. 149, "Amendment of SFAS No. 133 on
Derivative Instruments and Hedging Activities," or SFAS 149. SFAS 149 amends and
clarifies financial accounting and reporting for derivative instruments,
including certain derivative instruments embedded in other contracts and for
hedging activities under SFAS No. 133, "Accounting for Derivative Instruments
and Hedging Activities." The amendments set forth in SFAS 149 require that
contracts with comparable characteristics be accounted for similarly. SFAS 149
is generally effective for contracts entered into or modified after June 30,
2003 and for hedging relationships designated after June 30, 2003. The
implementation of SFAS 149 did not have a material effect on our financial
position, results of operations or cash flows.
In May 2003, the FASB issued SFAS No. 150 "Accounting for Certain Financial
Instruments with Characteristics of Both Liability and Equity," or SFAS 150.
SFAS 150 establishes standards regarding the classification and measurement of
certain financial instruments with characteristics of both liabilities and
equity. SFAS 150 is effective for financial instruments entered into or modified
after May 31, 2003, and otherwise is effective at the beginning of the first
interim period beginning after June 15, 2003. The implementation of SFAS 150 did
not have a material effect on our financial position, results of operations or
cash flows.
ITEM 3: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The assets and businesses of BioVeris have historically been owned and operated
by IGEN, which holds all cash in a centralized treasury and has provided all of
the necessary funding for the operations of BioVeris. Accordingly, no cash is
reflected on the consolidated balance sheets of BioVeris and there are no market
risk sensitive instruments.
BioVeris is exposed to changes in exchange rates where it sells direct in local
currencies, primarily in the United Kingdom and Germany. Certain other foreign
sales denominated in U.S. dollars and have no exchange rate risk. Gains and
losses resulting from foreign currency transactions have historically not been
material.
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ITEM 4: CONTROLS AND PROCEDURES
The Company, under the supervision and with the participation of its management,
including the Chief Executive Officer and Chief Financial Officer, evaluated the
effectiveness of the design and operation of the Company's "disclosure controls
and procedures" (as defined in Rule 13a-15(e) under the Exchange Act) as of the
end of the period covered by this report. Based on that evaluation, the Chief
Executive Officer and the Chief Financial Officer concluded that the Company's
disclosure controls and procedures are effective to ensure that information
required to be disclosed in the reports that the Company files or submits under
the Exchange Act is recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange Commission's rules and forms.
There have not been any changes in the Company's internal control over financial
reporting during the quarter ended December 31, 2003 that have materially
affected, or are reasonably likely to materially affect, its internal control
over financial reporting.
PART II OTHER INFORMATION
ITEM 4
Item 6: Exhibits and Reports on Form 8-K.
(a) Exhibits:
31.1 Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
31.2 Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of
2002
32.1 Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
32.2 Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of
2002
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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.
BioVeris Corporation
Date: February 13, 2004
/s/ George V. Migausky
- ----------------------
George V. Migausky
Vice President of Finance and
Chief Financial Officer
(On behalf of the Registrant and as
Its Principal Financial Officer.
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