Form 10-Q SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 1997 Commission File No. 000-19495 Embrex, Inc. --------------------------------------------------- (Exact name of registrant as specified in its charter) North Carolina 56-1469825 - ------------------------------------------------------------------- (State or other jurisdiction of (IRS Employer incorporation or organization) Identification No.) 1035 Swabia Court, Durham, NC 27703 -------------------------------------------------- (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 ---- ---- The number of shares of Common Stock, $0.01 par value, outstanding as of October 31, 1997, was 8,235,949. EMBREX, INC. INDEX Page ---- Part I Financial Information: Item 1: Financial Statements Balance Sheets.....................................................................3 of 12 Statements of Operations...........................................................4 of 12 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.................................................................10 of 12 Item 2: Changes in Securities.............................................................10 of 12 Item 3: Defaults Upon Senior Securities...................................................10 of 12 Item 4: Submission of Matters to a Vote of Security Holders...............................10 of 12 Item 5: Other Information.................................................................10 of 12 Item 6: Exhibits and Reports on Form 8-K..................................................10 of 12 Signatures 11 of 12 Exhibit Index.............................................................................12 of 12 PART I - FINANCIAL INFORMATION Item 1 - Financial Statements Embrex, Inc. CONSOLIDATED BALANCE SHEETS (DOLLARS IN THOUSANDS) SEPTEMBER 30 DECEMBER 31 1997 1996 ---------- ---------- (UNAUDITED) ASSETS CURRENT ASSETS Cash and cash equivalents .......................................... $ 9,338 $ 9,036 Short-term investments ............................................. 0 876 Inventories: Materials and supplies ......................................... 854 1,061 Product ........................................................ 493 573 Accounts receivable - trade ........................................ 2,788 2,313 Other current assets ............................................... 515 124 -------- -------- TOTAL CURRENT ASSETS ........................................... 13,988 13,983 INOVOJECT(R)SYSTEMS UNDER CONSTRUCTION ................................. 651 530 INOVOJECT(R)SYSTEMS .................................................... 20,514 18,193 Less accumulated depreciation .......................................... (11,162) (8,499) -------- -------- 9,352 9,694 EQUIPMENT, FURNITURE AND FIXTURES ...................................... 3,000 2,607 Less accumulated depreciation and amortization ..................... (1,933) (1,695) -------- -------- 1,067 912 OTHER ASSETS: Goodwill, patents, and exclusive licenses of patentable technology (net of accumulated amortization of $70 in 1997 and $58 in 1996) 335 125 Other non-current assets ........................................... 79 310 -------- -------- TOTAL ASSETS ........................................................... $ 25,472 $ 25,554 ======== ======== LIABILITIES AND SHAREHOLDERS' EQUITY Current Liabilities Accounts payable ................................................... $ 1,418 $ 1,355 Accrued expenses ................................................... 1,844 1,087 Current portion of capital lease obligations ....................... 2,692 3,080 Current portion of long-term debt .................................. 322 909 -------- -------- TOTAL CURRENT LIABILITIES ...................................... 6,276 6,431 CAPITAL LEASE OBLIGATIONS, less current portion ........................ 3,762 5,806 LONG-TERM DEBT, less current portion ................................... 12 8 SHAREHOLDER'S EQUITY Common Stock, $.01 par value: Authorized - 30,000,000 shares Issued and outstanding - 8,236,304 and 8,043,490 shares at September 30, 1997 and December 31, 1996, respectively ........................ 82 80 Additional paid-in capital ......................................... 54,765 53,742 Currency translation adjustments ....................................... 50 180 Accumulated deficit ................................................ (39,475) (40,693) -------- -------- TOTAL SHAREHOLDERS' EQUITY ..................................... 15,422 13,309 -------- -------- TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY ............................. $ 25,472 $ 25,554 ======== ======== 3 Embrex, Inc. CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (DOLLARS IN THOUSANDS, EXCEPT PER SHARE DATA) THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30 SEPTEMBER 30 ------------------------------------------------ 1997 1996 1997 1996 ---------------------------------------------- REVENUES INOVOJECT(R)SYSTEM revenue............................. $ 6,252 $ 5,188 $17,538 $ 14,129 Product sales.......................................... 246 408 745 1,043 Other revenue.......................................... 33 45 94 132 ----------- -------- ------- -------- TOTAL REVENUES..................................... 6,531 5,641 18,377 15,304 COST OF PRODUCT SALES AND INOVOJECT(R)SYSTEM REVENUES...... 3,194 2,943 8,927 8,093 ------- ------ ------ ------- GROSS PROFIT....................................... 3,337 2,698 9,450 7,211 OPERATING EXPENSES General and administrative............................. 1,539 1,022 4,153 2,703 Sales and marketing.................................... 87 80 458 217 Research and development............................... 959 1,023 2,955 2,682 -------- ------ ------- ------------ TOTAL OPERATING EXPENSES........................... 2,585 2,125 7,566 5,602 OPERATING INCOME........................................... 752 573 1,884 1,609 OTHER INCOME (EXPENSE) Interest income........................................ 118 94 363 250 Interest expense....................................... (260) (398) (865) (1,241) -------- -------- --------- ---------- TOTAL OTHER EXPENSE................................ (142) (304) (502) (991) -------- -------- ---------- -------- INCOME BEFORE TAXES........................................ 610 269 1,382 618 INCOME TAXES ........................................... 70 66 164 164 --------- --------- ---------- -------- NET INCOME .......................................... $ 540 $ 203 $ 1,218 $ 454 ======== ================================== Net income per share of Common Stock........................ $ .06 $ .03 $ .15 $ .06 ========= ========= ===================== WEIGHTED AVERAGE SHARES OF COMMON STOCK OUTSTANDING (in thousands).................. 8,369 7,442 8,327 7,266 4 Embrex, Inc. CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (DOLLARS IN THOUSANDS) NINE MONTHS ENDED SEPTEMBER 30 1997 1996 ---------- -------- OPERATING ACTIVITIES Net income ........................................................... $ 1,218 $ 454 Adjustments to reconcile net income to net cash (used in) provided by operating activities: Depreciation and amortization .................................... 2,935 2,841 Changes in operating assets and liabilities: Accounts receivable, inventories and other current assets .... (714) (760) Accounts payable and accrued expenses ........................ 886 150 ------- ------- NET CASH PROVIDED BY OPERATING ACTIVITIES ................................ 4,325 2,685 INVESTING ACTIVITIES Purchases of short-term investments .................................. 876 97 Purchases of INOVOJECT(R)systems, equipment, furniture and fixtures .. (2,615) (3,692) Decrease in other noncurrent assets .................................. 1 95 ------- ------- NET CASH USED IN INVESTING ACTIVITIES .................................... (1,738) (3,500) FINANCING ACTIVITIES Issuance of common stock ............................................. 307 260 Proceeds from long-term debt ......................................... (160) 8 Proceeds from short-term debt ........................................ 0 468 Payments on short-term debt .......................................... 0 (30) Proceeds from capital lease obligations .............................. 128 2,141 Payments on capital lease obligations .................................... (2,560) (2,020) ------- ------- NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES ...................... (2,285) 827 ------- ------- INCREASE IN CASH AND CASH EQUIVALENTS .................................... 302 12 Cash and cash equivalents at beginning of period ..................... 9,036 5,354 ------- ------- CASH AND CASH EQUIVALENTS AT END OF PERIOD ............................... $ 9,338 $ 5,366 ======= ======= SUPPLEMENTAL SCHEDULE OF NONCASH FINANCING ACTIVITY: During 1997, $425,000 of outstanding debentures along with $66,000 of accrued interest were converted into 98,267 shares of Common Stock net of unamortized debt issuance costs totaling $1,000. In addition, 419 shares of Embrex Common Stock were issued pursuant to the non-cash exercise of warrants related to the initial sale of such debentures. 5 EMBREX, INC. FORM 10-Q September 30, 1997 NOTES TO CONSOLIDATED INTERIM CONDENSED FINANCIAL STATEMENTS (Unaudited) NOTE 1 -- BASIS OF PRESENTATION The accompanying unaudited financial statements include the accounts of Embrex, Inc. and its wholly owned subsidiaries, Embrex Europe Limited and Embrex Sales, Inc. (collectively referred to as the "Company") and have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by generally accepted accounting principles. 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 nine month period ended September 30, 1997 are not necessarily indicative of the results that may be attained for the entire year. For further information, refer to the financial statements and notes thereto included in the Company's Form 10-K for the year ended December 31, 1996. NOTE 2 - NET INCOME PER SHARE Net income or earnings per share (primary earnings per share) are computed by dividing net income by the weighted average number of shares of Common Stock and common stock equivalents outstanding during the period. Common stock equivalents consist of stock options, warrants, and common shares purchasable under the Employee Stock Purchase Plan and are computed using the treasury stock method. In February 1997, the Financial Accounting Standards Board issued Statement No. 128, EARNINGS PER SHARE, which is required to be adopted on December 31, 1997. At that time, the Company will be required to change the method currently used to compute earnings per share and to restate all prior periods. Under the new requirements for calculating primary earnings per share, the dilutive effect of stock options will be excluded. The difference between primary and fully diluted net income per common share is not significant in all periods presented. The impact of Statement 128 on the calculation of fully diluted earnings per share is not expected to be material. NOTE 3 - RECLASSIFICATION Certain 1996 amounts in the accompanying financial statements have been reclassified to conform to the presentation format adopted in the fourth quarter of 1996. These reclassifications had no effect on previously reported net income, loss, or shareholders equity. 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. RESULTS OF OPERATIONS Three Months Ended September 30, 1997 and 1996 Consolidated revenues for the third quarter of 1997 totaled $6.5 million, representing a 16.0% increase of $890,000 over the same period in 1996. During this time, the Company achieved a 20.5% increase of approximately $1.1 million in INOVOJECT(R) system revenue to $6.3 million from $5.2 million during the comparable period in 1996. Substantially all of the 1997 and 1996 INOVOJECT(R) system revenues were derived from INOVOJECT(R) system lease fees, with the growth in lease revenues primarily due to a 9.5% year-over-year increase in the number of INOVOJECT(R) systems operating under lease agreements. In addition, third-quarter 1997 revenues included amounts attributable to the sale of INOVOJECT(R) systems and parts to a foreign distributor. The previously announced delay associated with obtaining British regulatory approval for the sale of Bursamune(TM) in the United Kingdom has reduced the Company's ability to generate revenue from product sales. Product sales declined 39.7% to $246,000 from the $408,000 recorded a year earlier, which included sales in the 1996 period of the Company's proprietary viral neutralizing factor (VNF(R)) product, which is a key component of Bursamune(TM), to Fort Dodge Animal Health, a division of American Home Products. The purchase by Fort Dodge reflected the then-anticipated British regulatory approval. Overall, the Company's gross profit margin performance of 51% during the third quarter exceeded the 48% level achieved during the comparable 1996 period. Operating expenses increased to $2.6 million for the third quarter of 1997, up $460,000 from the comparable 1996 amount. The increase, which principally reflects stepped-up activity attributable to general corporate expense associated with higher sales and legal fees pertaining to patent infringement matters, was partially offset by a $64,000 reduction in product research, development, and manufacturing services expenditures. Net other expense decreased 53.3% from $304,000 in the 1996 period to $142,000 in 1997 due to the combination of diminishing interest expense payments on INOVOJECT(R) system lease lines, and an increase in interest earned on invested cash. The stronger bottom-line performance demonstrates the benefit of the Company's focus on achieving INOVOJECT(R) system operating efficiencies and constraining selling expenses, the combination of which enabled the Company to post record third quarter net income. Net income of $540,000 for the quarter ended September 30, 1997 increased to 266% of the $203,000 profit earned during the comparable 1996 period. Earnings per share doubled, to $.06 for the 1997 third quarter versus $.03 per share in the comparable 1996 period. This improvement in per-share earnings was achieved in spite of a 12.5% increase in the number of weighted average shares of common stock outstanding to 8.369 million shares compared to 7.442 million at the end of the third quarter of 1996, chiefly reflecting the issuance of shares pursuant to the exercise of outstanding warrants and convertible debentures. 7 Nine Months Ended September 30, 1997 and 1996 Consolidated revenues for the nine months ended September 30, 1997 totaled $18.4 million, up 20% from $15.3 million a year earlier. This increase is principally attributable to stronger INOVOJECT(R) system revenues which account for 95.4% of the $18.4 million total. Consistent with the 9.5% increase from September 30, 1996 in the number of INOVOJECT(R) systems installed under lease agreements, INOVOJECT(R) system revenues showed a year-over-year increase of 24.1%, growing $3.4 million to $17.5 million. Substantially all of the 1997 and 1996 INOVOJECT(R) system revenues were derived from INOVOJECT(R) system lease fees. Cost of product and INOVOJECT(R) system revenues totaled $8.9 million (48.6% of total revenues) for the first nine months of 1997 compared to $8.1 million (52.9% of total revenues) for the same 1996 period, resulting in nine-month gross margins of 51.4% and 47.1%, respectively. Operating expenses for the nine months ended September 30, 1997 increased to $7.6 million, up $2.0 million from the comparable 1996 amount. The increase principally reflects $1.5 million attributable to general corporate expense related to higher sales and legal fees associated with patent infringement matters; $241,000 relating to enlarging the installed base of INOVOJECT(R) systems, as well as the cost of expanding the Company's Asian presence in anticipation of the approval of vaccines for IN OVO delivery; and $273,000 associated with product research, development, and manufacturing activities. Net other expense decreased by $489,000 from $991,000 for the nine months ended September 30, 1996 to $502,000 for the same 1997 period. This 49.3% improvement is the result of the combination of a $376,000 decrease in interest expense attributable to reductions in lease and debt obligations, and a $113,000 increase in interest earned on invested cash. Net income for the nine months ended September 30, 1997 of $1,218,000 represents 268% of the $454,000 reported for the same period ended September 30, 1996. The increase of $764,000 translates into earnings during the first nine months of 1997 that, at $.15 per weighted average share of common stock outstanding, equals 250% of the $.06 per weighted average share reported for the nine months ended September 30,1996. This improvement in nine-month 1997 earnings was accompanied by a 14.6% increase of 1.1 million in the number of weighted average shares of common stock outstanding from 7.266 million at September 30, 1996 to 8.327 million at September 30, 1997, chiefly reflecting the issuance of shares pursuant to the exercise of outstanding warrants and convertible debentures. Management anticipates further revenue growth throughout the balance of 1997 relative to the levels achieved in 1996, although generally the year-over-year rate of growth has slowed as compared with 1995 periods. Due to the Company's substantial penetration of markets in the United States and Canada for its INOVOJECT(R) system, revenue growth is expected to come primarily from new INOVOJECT(R) system leases in other countries, product sales of VNF(R) to vaccine manufacturers, and sales of its Bursaplex(TM) (previously known as "BDA-BLEN") product to poultry producers. The rate at which the marketplace will accept its INOVOJECT(R) system technology outside the United States and Canada, the timing of approvals outside the United States and Canada of third-party vaccines for IN OVO use, and levels of INOVOJECT(R) system utilization by domestic and foreign hatchery operators will impact the pace of revenue growth and the ability of the Company to sustain, or improve, profitability from the installation and operational throughputs of 8 INOVOJECT(R) systems. Management will continue to focus on operating efficiencies and revenue growth in an effort to maintain or improve gross margins, and will continue to carefully balance selling, operating, and interest expenses against its goal of continuing and increasing profitability. CHANGES IN FINANCIAL CONDITION, LIQUIDITY, AND CAPITAL RESOURCES At September 30, 1997, the Company's cash, cash equivalents and short-term investment balances totaled $9.3 million, down approximately $574,000 from the $9.9 million on hand at year-end 1996. Embrex believes it will be able to continue its use of existing cash in conjunction with cash flow generated by operations to fund its capital needs and continued international expansion during the balance of 1997. Operating activities generated $4.3 million in cash during the first nine months of 1997, reflecting increases attributable to $1,218,000 in net income, $2.9 million from depreciation and amortization, and $886,000 from increases in accounts payable and accrued expenses, the total of which was then offset by $714,000 chiefly attributable to increases in accounts receivable and other current assets. During the same period, investing activities consumed a net $1.7 million principally due to the use of $2.6 million for the purchase of INOVOJECT(R) systems to accommodate domestic and international growth. Net financing activities consumed $2.3 million during the period largely as a result of repayments on capital lease obligations. In addition, proceeds from the exercise of options to purchase common stock provided $307,000. As of September 30, 1997 the Company had outstanding purchase commitments of approximately $2.7 million related to the production of the Company's Bursaplex(TM) product, and materials and supplies for the construction and maintenance of INOVOJECT(R) egg injection systems. Additionally, in connection with the January 1996 agreement reached with Select Laboratories (as discussed in the Company's Form 10-K for the year ended December 31, 1996), the Company is obligated to purchase all existing inventories of raw material, Bursaplex(TM), and related materials from Select within thirty months following the January 20, 1997 receipt of IN OVO approval of the Bursaplex(TM) product being manufactured for Embrex. Based on its current operations, management believes that its available cash and short-term investments, together with cash flow from operations and existing equipment financing lines, will be sufficient to meet its foreseeable cash requirements. FORWARD-LOOKING STATEMENTS This report contains "forward-looking" statements. These statements involve risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward looking statements, including without limitation the Company's dependence on certain customers; the ability of the Company, its manufacturing and marketing partners and others to obtain regulatory approval for products to be delivered IN OVO, which are dependent on a number of factors, including the results of trials, the discretion of regulatory officials, and any potential changes in regulations; the Company's ability to generate future cash flow from operations; continued demand for the INOVOJECT(R) system; the successful outcome of patent litigation; the Risk Factors described in the Company's Form 10-K for the year ended December 31, 1996 (Exhibit 99); and other risks detailed from time to time in the Company's Securities and Exchange Commission filings, including the Company's reports on Forms 10-Q, 10-K, and 8-K. 9 Item 3. Quantitative and Qualitative Disclosures About Market Risk. Not applicable. PART II. OTHER INFORMATION Item 1. Legal Proceedings. For a description of certain patent infringement proceedings initiated by the registrant and related legal proceedings, see registrant's Form 10-K for the year ended December 31, 1996 filed with the Securities and Exchange Commission on March 31, 1997, as amended by Form 10-K/A filed with the Securities and Exchange Commission on April 15, 1997. Item 2. Changes in Securities. During 1997, $425,000 of outstanding debentures along with $66,000 of accrued interest were converted into 98,267 shares of Common Stock net of unamortized debt issuance costs totaling $1,000 pursuant to a claim of exemption from registration under Section 3(a)(9) of the Securities Act of 1933, as amended. In addition, 419 shares of Embrex Common Stock were issued pursuant to the non-cash exercise of outstanding warrants (which were originally issued to the placement agent for such debentures), pursuant to a claim of exemption from registration under Section 4(2) of the Securities Act of 1933, as amended, based on the private nature of the transaction, not involving a public offering, with a limited number of individuals. 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. As previously announced, Embrex has completed an amendment to its contract with Tyson Foods, Incorporated to extend its relationship through December 31, 2004. The amendment also provides for termination only upon twelve months notice by either party (as provided in the existing contract), and a right of first refusal for Embrex to meet any offer being considered by Tyson for any method of chick vaccination. Item 6. Exhibits and Reports on Form 8-K. (a) Exhibits 27 - Financial Data Schedule. (b) Reports on Form 8-K. Not applicable. 10 SIGNATURES In accordance with 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: November 10, 1997 EMBREX, INC. By: /s/ Randall L. Marcuson ------------------------------- Randall L. Marcuson President and Chief Executive Officer By: /s/ Don T. Seaquist -------------------------------- Don T. Seaquist Vice President, Finance and Administration Embrex, Inc. File No. 000-19495 Form 10-Q For the Quarterly Period Ended September 30, 1997 EXHIBIT INDEX Sequential Exhibit Page Number 27 Financial Data Schedule