UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Form 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended March 31, 2002
Commission File No. 000-19495
Embrex, Inc.
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(Exact name of registrant as specified in its charter)
North Carolina 56-1469825
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(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
1040 Swabia Court, Durham, NC 27703
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(Address of principal executive offices) (Zip Code)
Registrant's telephone no. including area code: (919) 941-5185
Check whether the registrant (1) filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the past 12
months (or for such shorter period that the registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days.
Yes X No __
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The number of shares of Common Stock, $0.01 par value, outstanding as of April
30, 2002 was 8,111,884.
EMBREX, INC.
INDEX
Part I Page
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Financial Information:
Item 1: Financial Statements
Consolidated Balance Sheets........................... 3 of 12
Consolidated Statements of Operations ................ 4 of 12
Consolidated Statements of Cash Flows ................ 5 of 12
Notes to Consolidated Financial Statements ........... 6 of 12
Item 2:
Management's Discussion and Analysis of
Financial Condition and Results of Operations ........ 7 of 12
Item 3:
Quantitative and Qualitative Disclosures
About Market Risk .................................... 10 of 12
Part II
Other Information:
Item 1: Legal Proceedings .................................... 11 of 12
Item 2: Changes in Securities ................................ 11 of 12
Item 3: Defaults Upon Senior Securities ...................... 11 of 12
Item 4: Submission of Matters to a Vote of Security Holders .. 11 of 12
Item 5: Other Information .................................... 11 of 12
Item 6: Exhibits and Reports on Form 8-K ..................... 11 of 12
Signatures ................................................... 12 of 12
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PART I - FINANCIAL INFORMATION
Item 1: Financial Statements
- ----------------------------
Embrex, Inc.
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Consolidated Balance Sheets
(Dollars in thousands)
March 31, December 31,
2002 2001
--------------- ---------------
(unaudited)
ASSETS
Current Assets
Cash and cash equivalents $ 5,846 $ 3,907
Restricted cash 346 275
Accounts receivable - trade, net 6,505 7,128
Inventories:
Materials and supplies 1,373 1,361
Product 849 900
Other current assets 824 800
--------------- ---------------
Total Current Assets 15,743 14,371
Inovoject Systems Under Construction 1,642 1,560
Inovoject Systems 32,347 32,555
Less accumulated depreciation (25,045) (24,754)
--------------- ---------------
7,302 7,801
Equipment, Furniture and Fixtures 12,797 12,123
Less accumulated depreciation and amortization (4,578) (4,172)
--------------- ---------------
8,219 7,951
Other Assets:
Goodwill, patents and exclusive licenses of patentable technology (net of
accumulated amortization of $146 in 2002 and $144 in 2001) 737 752
Other long-term assets 1,567 1,623
--------------- ---------------
Total Assets $ 35,210 $ 34,058
=============== ===============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities
Accounts payable $ 555 $ 1,210
Accrued expenses 3,287 3,245
Deferred revenue 90 28
Product warranty accrual 238 218
--------------- ---------------
Total Current Liabilities 4,170 4,701
Long-term debt, less current portion 44 43
Shareholders' Equity
Common Stock,$.01 par value:
Authorized - 30,000,000 shares Issued and outstanding - 8,031,351 net
of 1,175,216 treasury shares and 7,998,168 net of 1,175,216 treasury
shares at March 31, 2002 and December 31, 2001, respectively 92 90
Additional paid-in capital 60,229 59,932
Accumulated other comprehensive loss (1,659) (776)
Accumulated deficit (13,464) (15,730)
Treasury stock (14,202) (14,202)
--------------- ---------------
Total Shareholders' Equity 30,996 29,314
--------------- ---------------
Total Liabilities and Shareholders' Equity $ 35,210 $ 34,058
=============== ===============
3
Embrex, Inc.
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Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
Three Months Ended
March 31
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2002 2001
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Revenues
Inovoject(R) System revenue $ 9,602 $ 9,888
Product sales 828 696
Other revenue 926 217
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Total Revenues 11,356 10,801
Cost of Product Sales and Inovoject(R) System Revenues 4,077 4,306
---------------- ----------------
Gross Profit 7,279 6,495
Operating Expenses
General and administrative 1,664 1,893
Sales and marketing 661 605
Research and development 2,343 1,689
---------------- ----------------
Total Operating Expenses 4,668 4,187
Operating Income 2,611 2,308
Other Income (Expense)
Interest income 40 44
Interest expense (4) (6)
Foreign Currency Gain (Loss) 16 (11)
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Total Other Income 52 27
---------------- ----------------
Income Before Taxes 2,663 2,335
Income Taxes 396 269
---------------- ----------------
Net Income $ 2,267 $ 2,066
================ ================
Net Income per share of Common Stock:
Basic $ 0.28 $ 0.26
Diluted $ 0.26 $ 0.24
Number of Shares Used in Per Share Calculation:
Basic 8,031 7,927
Diluted 8,741 8,576
4
Embrex, Inc.
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Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
Three Months Ended
March 31
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2002 2001
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Operating Activities
Net Income $ 2,267 $ 2,066
Adjustments to reconcile net income to net cash provided by
operating activities:
Depreciation and amortization 1,151 1,096
Changes in operating assets and liabilities:
Accounts receivable, inventories and other current assets 567 (1,399)
Accounts payable, accrued expenses, deferred revenue and
warranty accrual (530) (1,323)
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Net Cash Provided By Operating Activities 3,455 440
Investing Activities
Purchases of Inovoject(R) systems, equipment, furniture and fixtures (1,000) (699)
Reductions (additions) to patents and other non-current assets 69 (559)
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Net Cash Used in Investing Activities (931) (1,258)
Financing Activities
Issuance of common stock 298 975
Changes in long-term debt 1 2
Payments on capital lease obligations - (7)
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Net Cash Provided By (Used In) Financing Activities 299 970
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Increase in cash and cash equivalents 2,823 152
Currency translation adjustments (883) (412)
Cash and cash equivalents at beginning of period 3,907 2,966
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Cash And Cash Equivalents At End Of Period $ 5,846 $ 2,706
======= ========
5
EMBREX, INC.
FORM 10-Q
March 31, 2002
NOTES TO INTERIM CONSOLIDATED CONDENSED FINANCIAL STATEMENTS (Unaudited)
Note 1 - Basis of Presentation
The accompanying unaudited consolidated financial statements include the
accounts of Embrex, Inc. and its wholly owned subsidiaries, Embrex Europe
Limited, Embrex France s.a.s., Embrex Iberica, Embrex BioTech Trade (Shanghai)
Co., Ltd. and Inovoject do Brasil Ltda. (the "Company") and have been prepared
in accordance with accounting principles generally accepted in the United States
for interim financial information and with the instructions to Form 10-Q and
Article 10 of Regulation S-X. Accordingly, these do not include all of the
information and notes required by accounting principles generally accepted in
the United States. In the opinion of management, all adjustments (consisting of
normal recurring accruals) considered necessary for a fair presentation of
financial condition and results of operations have been included. Operating
results for the three-month period ended March 31, 2002 are not necessarily
indicative of the results that may be attained for the entire year. For further
information, refer to the consolidated financial statements and notes thereto
included in the Company's Form 10-K for the year ended December 31, 2001.
Note 2 - Net Income Per Share
Basic net income per share was determined by dividing net income available for
common shareholders by the weighted average number of common shares outstanding
during each period presented. Diluted net income per share reflects the
potential dilution that could occur assuming conversion or exercise of all
issued and unexercised stock options.
Note 3 - Comprehensive Income
In June 1997, the FASB issued Statement No. 130, "Reporting Comprehensive
Income" (SFAS 130). This statement establishes standards for reporting and
display of comprehensive income and its components in the financial statements.
In accordance with SFAS 130, the Company has determined total comprehensive
income, net of tax, to be $1.4 million and $1.7 million for the three months
ended March 31, 2002 and 2001, respectively. Embrex's total comprehensive income
represents net income plus the after-tax effect of foreign currency translation
adjustments for the periods presented.
Note 4 - Segments
The Company operates in a single segment. The table below presents the Company's
operations by geographic area:
(In thousands)
(* Unaudited)
March 31, 2002 * March 31, 2001 *
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Net Revenue:
United States $ 8,279 $ 7,437
International 3,077 3,364
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Total $11,356 $10,801
==================================
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March 31, 2002 * December 31, 2001
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Total Assets:
United States $25,720 $23,230
International 9,490 10,828
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Total $35,210 $34,058
=========================================
Item 2. Management's Discussion and Analysis of Financial Condition and Results
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of Operations.
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The following discussion and analysis should be read in conjunction with the
Company's interim consolidated financial statements and related notes appearing
elsewhere in this report.
RESULTS OF OPERATIONS
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Three Months Ended March 31, 2002 and 2001
- ------------------------------------------
Consolidated revenues for the first quarter totaled $11.4 million, representing
an increase of 5% over 2001 first quarter revenues of $10.8 million.
Inovoject(R) system revenues amounted to $9.6 million for the 2002 first
quarter, a decrease of 3% compared to the 2001 first quarter revenues of $9.9
million. Most of the 2002 and 2001 Inovoject(R) system revenues were generated
from Inovoject(R) system lease fees. The contraction in Inovoject(R) system
revenues was primarily attributable to Inovoject(R) system sales in Japan and
Europe during 2001, which did not occur during the first quarter of 2002. The
sale, rather than the lease, of Inovoject(R) systems and other related devices
now and in the future may cause revenues to vary when compared quarter to
quarter.
Product sales, due to sales of Bursaplex(R), the Company's proprietary vaccine
for the treatment of avian infectious bursal disease (IBD), increased 19% to
$828,000 in the 2002 first quarter as compared to $696,000 for the same period
in 2001, primarily due to increased sales in Asia, Latin America and North
America.
The first-quarter increase in gross margin from 60%, for 2001 results, to 64% in
2002 resulted from the 5% increase in revenues for first quarter 2002 versus
first quarter 2001 and from a three-fold increase in revenue from collaborations
and grants. This increase is primarily due to funds from Cobb-Vantress
supporting the Company's gender sort project and funds from a federal Advanced
Technology Program (ATP) grant supporting the Company's research collaboration
with Origen Therapeutics. Without this revenue from collaborations and grants in
both periods, first quarter 2002 gross margin would have been 61%, a two point
increase over the first quarter 2001 gross margin of 59%.
Total operating expenses amounted to $4.7 million for the first quarter of 2002
versus $4.2 million for the first quarter of 2001. General and administrative
expenses were $0.2 million less during the first quarter of 2002 due primarily
to professional services related to the accounting investigation in the
Company's European subsidiary during 2001. Sales and marketing expenses were
$0.1 million more during the first quarter of 2002 than the first quarter of
2001 due to increased new business activity and infrastructure development.
Research and development expenses were $0.7 million more during the first
quarter 2002 than the first quarter of 2001 due to development work on the
gender sort project, Inovocox(TM), the Company's in ovo Coccidiosis vaccine
project, and the Company's research collaboration with Origen Therapeutics.
7
Net other income amounted to $52,000 for the first quarter of 2002 compared to
$27,000 for the first quarter of 2001. The $25,000 change is primarily
attributable to a recognized currency translation gain during the first quarter
of 2002 versus a currency translation loss during the first quarter of 2001.
Bursaplex(R) revenue and the collaboration revenue growth and improved operating
margins resulted in first-quarter pre-tax net income of $2.7 million, an
increase of 14% over pre-tax net income of $2.3 million for the same period in
2001. Net income of $2.3 million, during the first quarter of 2002, increased
10% over net income of $2.1 million for the first quarter of 2001. Income taxes
increased 47% due to a three percentage point increase in the effective tax rate
from 12% for the first quarter of 2001 to 15% for the first quarter of 2002.
Some $4.2 million of deferred tax assets were carried over to 2002. As these
assets are used during 2002, the effective tax rate is expected to approach 20%
by year-end and average between 15% and 18% for the year. Net income per common
share was $0.26 for the 2002 first quarter based on 8.7 million average diluted
shares outstanding, compared to net income of $0.24 per share based on 8.6
million average diluted shares outstanding in the first quarter of 2001.
The Company estimates that as of March 31, 2002, it was vaccinating in excess of
80% of the broiler birds grown in the United States during the first three
months of 2002. Given its market penetration, the Company expects only moderate
revenue and earnings growth in 2002 from existing Inovoject(R) system operations
in the United States and Canada, higher revenue and earnings growth from new
Inovoject(R) system leases in other countries, and sales of Bursaplex(R) product
to poultry producers worldwide. However, the rate at which the marketplace will
accept the Inovoject(R) system technology outside the United States and Canada,
possible competition within the United States once the Company's USDA patent
expires in June 2002, the timing of regulatory approvals of Bursaplex(R) and
third-party vaccines for in ovo use outside the United States and Canada,
start-up costs in new markets, possible variability in United States hatchery
bird production as a result of grain price fluctuations, and variability in the
demand for, and pricing of, U.S. poultry and poultry products both inside and
outside the United States, will impact the pace of revenue growth, if any, and
the sustainability of profitability from the installation and operational
throughputs of Inovoject(R) systems. The Company currently has Inovoject(R)
systems either installed or on trial in 31 countries, including the United
States and Canada.
Bursaplex(R) is a product which uses the Company's Viral Neutralizing Factor
(VNF(R)) technology to form an antibody-vaccine virus complex when combined with
an infectious bursal disease (IBD) virus. To date, regulatory approval for
Bursaplex(R) has been received in 22 countries including the United States and
regulatory approval is pending in 11 countries.
The Company's VNF(R) technology is also used in an IBD vaccine produced by
Cyanamid Webster, a unit of Fort Dodge Animal Health, a division of Wyeth,
formerly American Home Products, which has been marketed by Fort Dodge in
certain European countries under Fort Dodge's trade name Bursamune(R). To date,
Bursamune(R) has received regulatory approval in South Africa, Spain, Italy,
Poland and the United Kingdom. During the second quarter of 2001, Fort Dodge
advised its distributors that certain other Fort Dodge products, which compete
with Bursamune(R), could potentially be used in ovo in place of Bursamune(R).
Also, Fort Dodge has indicated to Embrex that it does not intend to continue
marketing Bursamune(R) after existing inventories are used and does not intend
to seek further regulatory approvals. Embrex believes Fort Dodge remains
obligated under its agreements with Embrex. After discussions with Fort Dodge to
reach resolution on this matter were unsuccessful, the Company filed a complaint
on April 15, 2002 in Wake County Superior Court, North Carolina alleging breach
of contract relative to their obligations to develop, register and market
Bursamune(R) in the territories of Europe, the Middle East and Africa. Embrex
does not expect to generate significant revenues from either the sales of VNF(R)
to Fort
8
Dodge or the royalties generated from Fort Dodge's Bursamune(R) sales.
For the rest of 2002, the goals of management are to maintain revenue growth and
profitability, to continue efforts to achieve worldwide placements of the
Inovoject(R) system and other related devices, to obtain regulatory approvals
and initiate marketing of Bursaplex(R) in these markets, to continue development
of proprietary in ovo vaccines and to develop enhancements to the Inovoject(R)
system. Growth in Inovoject(R) systems and product revenues during 2002 will be
dependent on the rate at which markets outside the United States and Canada
accept the Inovoject(R) system technology, possible competition within the
United States once the patent expires, the timing of regulatory approvals for
Bursaplex(R) and third-party vaccines for in ovo use outside the United States
and Canada, start-up costs in new markets, possible variability in United States
bird production as a result of grain price fluctuations, and variability in
demand for, and pricing of, U.S. poultry and poultry products both inside and
outside the United States.
CHANGES IN FINANCIAL CONDITION, LIQUIDITY, AND CAPITAL RESOURCES
- ----------------------------------------------------------------
At March 31, 2002, the Company's cash and cash equivalents amounted to $5.8
million, up $1.9 million from $3.9 million on hand at year-end 2001.
Operating activities generated $3.5 million in cash during the first three
months of 2002. Cash was provided by net income of $2.3 million, depreciation of
$1.2 million, and decreases in accounts receivable, inventories and other
current assets of $0.6 million offset by reductions in accounts payable and
accrued expenses of $0.5 million.
During the first quarter, investing activities used a net $0.9 million of cash,
largely attributable to the $1.0 million expended for additional Inovoject(R)
systems and other capital expenditures.
Financing activities provided $0.3 million, due to the issuance of common stock
through stock option exercises.
In April 1999, the Company obtained a $6.0 million secured revolving line of
credit from its bank, Branch Banking and Trust Company, which may be used for
working capital purposes. The term of this line of credit has been extended and
will now expire in April 2003. At March 31, 2002 there were no outstanding
borrowings under this line of credit facility.
In October 1998, the Company announced that the Board of Directors authorized a
share repurchase program (the "1998 Repurchase Program") to purchase up to 10%
of outstanding shares of Common Stock, or up to approximately 830,000 shares
over 18 months, in open market or privately negotiated transactions. During the
second quarter of 2000, Management was authorized by the Board of Directors to
extend the stock repurchase program (the "2000 Repurchase Program"). This
extension allowed for the purchase of up to 6% of outstanding shares, or up to
approximately 500,000 shares over 18 months in open market or privately
negotiated transactions. During 2001, the Company repurchased 201,216 shares of
its Common Stock for $3.2 million at an average price of $16.00 per share under
the 2000 Repurchase Program, which ended during the fourth quarter of 2001.
During the entire term of the 1998 Repurchase Program, the Company repurchased
830,000 shares of its Common Stock for $9.0 million at an average price of
$10.80 per share. During the entire term of the 2000 Repurchase Program, the
Company repurchased 345,216 shares of its Common Stock for $5.2 million at an
average price of $15.08 per share.
9
Based on its current operations, management believes that available cash and
cash equivalents, together with cash flow from operations, external funds for
R&D projects and its bank line of credit, will be sufficient to meet its
foreseeable cash requirements as these currently exist, but may continue to
explore additional, alternative funding opportunities with respect to
collaborative ventures and new product development.
FORWARD-LOOKING STATEMENTS
- --------------------------
Information set forth in this Quarterly Report on Form 10-Q contains various
"forward looking statements" within the meaning of Section 27A of the Securities
Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These
statements represent the Company's judgment concerning the future and are
subject to risks and uncertainties that could cause the Company's actual
operating results and financial position to differ materially. Such forward
looking statements can be identified by the use of forward looking terminology
such as "may," "will," "expect," "plan," "intend," "target," "anticipate,"
"estimate," "believe," or "continue," or the negative thereof or other
variations thereof or comparable terminology.
The Company cautions that any such forward-looking statements include statements
with respect to future products, services, markets and financial results. These
statements involve risks and uncertainties that could cause actual results to
differ materially, including without limitation the ability of the Company to
penetrate new markets, the ability to develop new products and technology, the
degree of market acceptance of new products, the outcome of the Company's patent
litigation appeal, the potential to lose protection of proprietary rights and
patents through expiration, invalidity, or otherwise, the complete commercial
development of potential future products or the ability to obtain regulatory
approval of products. Such approval is dependent upon a number of factors, such
as results of trials, the discretion of regulatory officials, and potential
changes in regulations. These statements are also contingent upon continued
growth and production levels of the global poultry industry and the economic
viability of certain markets. Additional information on these risks and other
factors which could affect the Company's consolidated financial results are
included in the Risk Factors described in Exhibit 99 to this report and in the
Company's other filings with the Securities and Exchange Commission, including
the Company's Forms 10-Q, 10-K and 8-K.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
- ------------------------------------------------------------------
Market risk is the risk of potential loss arising from adverse changes in market
rates and prices. The Company's primary market risk exposure is attributable to
changes in foreign currency exchange rates. Approximately 27% of revenues for
the first quarter of 2002 and 31% of revenues for the year ended December 31,
2001 were derived from operations outside the United States. The Company's
interim consolidated financial statements are denominated in U.S. Dollars and,
accordingly, changes in exchange rates between foreign currencies and the U.S.
Dollar will affect the translation of subsidiaries' financial results into U.S.
Dollars for purposes of reporting consolidated financial results. During 2002,
the U.S. Dollar strengthened against selected currencies compared to the same
period during 2001. If average exchange rates during 2002 had remained the same
as the average exchange rates for these currencies during 2001, then the
Company's 2002 revenues would have been $11.5 million instead of $11.4 million
representing a year-to-year growth rate of 7% as compared to the actual
exchange-adjusted growth rate of 5%.
Accumulated currency translation adjustments recorded as a separate component
(reduction) of shareholders' equity were ($1,659,000) at March 31, 2002 as
compared with ($776,000) at December 31, 2001. This $883,000 change was mainly
attributable to the devaluation of the Argentine Peso at the
10
beginning of 2002. However, aside from this initial adjustment due to the
currency devaluation in Argentina, Embrex's most significant foreign currency
exchange rate exposure is in the British Pound. To date, the Company has not
utilized any derivatives or other hedging instruments to affect this exposure.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
- ------- -----------------
The Company filed a complaint against Fort Dodge Animal Health, a division
of Wyeth, formerly American Home Products, on April 15, 2002 in Wake County
Superior Court, North Carolina alleging breach of contract by Fort Dodge of
its obligations to develop, register and market Bursamune(R) in Europe, the
Middle East and Africa.
For a description of certain patent infringement proceedings initiated by
the registrant and related legal proceedings, see the registrant's Form
10-K for the year ended December 31, 2001 filed with the Securities and
Exchange Commission on March 22, 2002.
Item 2. Changes in Securities
---------------------
Not applicable.
Item 3. Defaults Upon Senior Securities
- ------- -------------------------------
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
- ------- ---------------------------------------------------
Not applicable.
Item 5. Other Information
- ------- -----------------
Not applicable.
Item 6. Exhibits and Reports on Form 8-K
- ------- --------------------------------
(a) Exhibit 99 Risk Factors relating to the Company
(b) No reports on Form 8-K were filed during the quarter ending March 31,
2002.
11
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.
Date: May 14, 2002
EMBREX, INC.
By: /s/ Randall L. Marcuson
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Randall L. Marcuson
President and Chief Executive Officer
By: /s/ Don T. Seaquist
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Don T. Seaquist
Vice President, Finance and Administration
12