============================================= UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934. For the quarterly period ended September 30, 1997 Commission File Number 0-20945 MEDI-JECT CORPORATION 161 Cheshire Lane, Suite 100 Minneapolis, Minnesota 55441 (612) 475-7700 A Minnesota Corporation IRS Employer ID No. 41-1350192 ----------------- Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes X No ------- ------- The number of shares outstanding of the Registrant's Common Stock, $.01 par value, as of November 4, 1997 was 7,060,164. ================= 1 MEDI-JECT CORPORATION INDEX PAGE ---- PART I. FINANCIAL INFORMATION ITEM 1. Financial Statements (Unaudited) Balance Sheets, as of December 31, 1996 and September 30, 1997................................... 3 Statements of Operations for the nine months ended September 30, 1996 and 1997.......................... 4 Statements of Cash Flows for the nine months ended September 30, 1996 and 1997.......................... 5 Notes to Financial Statements........................ 6 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.................. 7 PART II. OTHER INFORMATION ITEM 6. Exhibits and Reports on Form 8-K..................... 9 SIGNATURES....................................................11 2 MEDI-JECT CORPORATION BALANCE SHEETS (UNAUDITED) December 31, 1996 September 30, 1997 ----------------- ------------------ ASSETS Current Assets: Cash and cash equivalents............................................. $ 9,575,240 $ 3,405,537 Marketable securities................................................. 1,464,277 4,998,897 Accounts receivable, less allowances for doubtful accounts of $12,983. 537,755 316,608 Inventories........................................................... 351,330 420,183 Prepaid expenses and other assets..................................... 86,589 113,056 ------------ ------------ 12,015,191 9,254,281 ------------ ------------ Equipment, furniture and fixtures, net................................ 595,590 1,073,991 ------------ ------------ Patent rights......................................................... 345,010 367,136 ------------ ------------ $ 12,955,791 $ 10,695,408 ============ ============ LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable...................................................... $ 353,456 $ 247,391 Accrued expenses and other liabilities................................ 331,446 361,974 Deferred revenue...................................................... 14,019 67,833 Capital lease obligations - current maturities........................ 32,747 15,197 Notes payable - current maturities.................................... 96,097 -- ------------ ------------ 827,765 692,395 ------------ ------------ Long-term liabilities: Capital lease obligations, less current maturities.................... 8,350 35,276 Shareholders' equity (deficit): Common Stock: $0.01 par; authorized 17,000,000 shares: 6,925,636 and 7,060,164 issued and outstanding at December 31, 1996 and September 30, 1997, respectively................ 69,256 70,602 Additional paid-in capital............................................ 23,590,887 23,764,742 Accumulated deficit................................................... (11,540,467) (13,867,607) ------------ ------------ Total shareholders' equity......................................... 12,119,676 9,967,737 ------------ ------------ $ 12,955,791 $ 10,695,408 ============ ============ See accompanying notes to financial statements. 3 MEDI-JECT CORPORATION STATEMENTS OF OPERATIONS (UNAUDITED) For Nine Months Ended For Three Months Ended ------------------------------------- ------------------------------------- September 30, 1996 September 30, 1997 September 30, 1996 September 30, 1997 ------------------------------------- ------------------------------------- Revenues: Sales...................................... $ 1,217,666 $ 1,223,630 $ 403,422 $ 340,456 Licensing & product development............ 1,231,835 1,238,602 545,797 269,372 ----------- ----------- ---------- ----------- 2,449,501 2,462,232 949,219 609,828 ----------- ----------- ---------- ----------- Operating Expenses: Cost of sales.............................. 724,908 811,122 223,190 263,114 Research and development................... 1,823,395 1,899,300 730,308 556,866 General and administrative................. 965,457 1,283,260 293,378 437,773 Sales and marketing........................ 739,323 1,167,370 272,443 401,385 ----------- ----------- ---------- ----------- 4,253,083 5,161,052 1,519,319 1,659,138 ----------- ----------- ---------- ----------- Net operating loss.............................. (1,803,582) (2,698,820) (570,100) (1,049,310) ----------- ----------- ---------- ----------- Other income (expense): Interest and other income.................. 94,754 396,639 25,269 124,318 Interest and other expense................. (26,966) (24,959) (6,785) (1,795) ----------- ----------- ---------- ----------- 67,788 371,680 18,484 122,523 ----------- ----------- ---------- ----------- Net loss........................................ $(1,735,794) $(2,327,140) $ (551,616) $ (926,787) =========== =========== ========== =========== Net loss per common share....................... $(.33) $(.13) Weighted average common shares outstanding................................ 6,999,152 7,057,035 Proforma net loss per common share (unaudited) (Note 3)....................... $(.33) $(.10) Proforma weighted average common shares outstanding (unaudited) (Note 3)........... 5,260,880 5,260,880 See accompanying Notes to Financial Statements 4 MEDI-JECT CORPORATION STATEMENTS OF CASH FLOWS (UNAUDITED) For Nine Months Ended --------------------------------------- September 30, 1996 September 30, 1997 --------------------------------------- Cash flows from operating activities: Net loss.................................................. $(1,735,794) $(2,327,140) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization............................. 109,417 190,463 Loss from disposal of asset............................... -- 17,080 Interest on marketable debt securities.................... -- (191,228) Changes in operating assets and liabilities: Accounts receivable..................................... (18,676) 221,147 Inventories............................................. (120,242) (68,853) Prepaid expenses and other assets....................... (35,493) (26,467) Accounts payable........................................ (166,498) (106,065) Accrued liabilities..................................... (233,911) 30,528 Deferred revenue........................................ 70,164 53,814 ----------- ----------- Net cash used in operating activities............................... (1,130,215) (2,206,721) ----------- ----------- Cash flows from investing activities: Purchases of marketable securities........................ -- (5,436,679) Proceeds from sales of marketable securities.............. -- 2,093,286 Purchases of equipment, furniture and fixtures............ (246,822) (609,062) Proceeds from sale of equipment, furniture and fixtures... -- 715 Purchases of patent rights................................ (97,468) (63,312) ----------- ----------- Net cash used in investing activities............................... (344,290) (4,015,052) ----------- ----------- Cash flows from financing activities: Principal payments on capital lease obligations........... (33,939) (27,034) Proceeds from issuance of common stock.................... 101,130 180,892 Proceeds from issuance of convertible preferred stock..... 3,812,500 -- Warrants issued........................................... 125,000 -- Proceeds from issuance of notes payable................... 187,500 -- Principal payments on notes payable....................... (498,663) (96,096) Offering costs............................................ (710,169) (5,692) ----------- ----------- Net cash provided by (used in) financing activities................. 2,983,359 52,070 ----------- ----------- Net increase (decrease) in cash and cash equivalents................ 1,308,854 (6,169,703) Cash and cash equivalents: Beginning of period........................................... 35,817 9,575,240 ----------- ----------- End of period................................................. $ 1,344,671 3,405,537 =========== =========== See accompanying Notes to Financial Statements. 5 MEDI-JECT CORPORATION NOTES TO FINANCIAL STATEMENTS 1. BASIS OF PRESENTATION The accompanying unaudited financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The accompanying financial statements and notes should be read in conjunction with the Company's 1996 audited financial statements and notes thereto. 2. INTERIM FINANCIAL STATEMENTS Operating results for the nine month period ended September 30, 1997 are not necessarily indicative of the results that may be expected for the year ending December 31, 1997. 3. PRO FORMA NET LOSS PER SHARE Pro forma net loss per share is computed by dividing the net loss attributable to common shareholders by the weighted average number of shares of common stock and common stock equivalents outstanding, after applying the treasury stock method and after giving effect to the reverse stock split and the automatic conversion of all outstanding shares of convertible preferred stock in accordance with the Company's initial public offering. Pursuant to certain requirements of the Securities and Exchange Commission, common stock equivalents include the impact of the issuance of stock, options and warrants within one year prior to the date of the initial filing of the Company's initial public offering ("IPO") at exercise prices less than the initial public offering price per share, whether or not the effects are antidilutive. 4. Inventories consist of the following: December 31, 1996 September 30, 1997 ----------------- ------------------ Raw Material $175,251 $186,663 Work in-process 119,575 112,289 Finished goods 56,504 121,231 -------- -------- $351,330 $420,183 ======== ======== 6 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Results of Operations Three and Nine Months Ended September 30, 1997 and 1996 Total revenues for the three and nine months ended September 30, 1997 were $609,828 and $2,462,232, respectively. Revenues for the three month period reflects a decrease of $339,391 or 36% over the same period in 1996. Revenues for the nine months ended September 30, 1997 reflect an increase of $12,731, less than 1%, over the same period in 1996. Total revenues include sales of injector products and services in addition to licensing and development fee income. Sales of injector products and services decreased by $62,966 in the three months ended September 30, 1997 compared to the three months ended September 30, 1996. The number of injector units sold remained approximately unchanged in the third quarter of 1997 as compared to the prior year period reflecting a decrease of $100 in the average selling price per unit. Sales of injector products and services increased by less than 1% to $1,223,630 in the nine months ended September 30, 1997 as compared to the same period in 1996. Injector sales, which account for a majority of product sales in each of these periods, remained approximately flat in spite of a 25% increase in unit volume in the 1997 period. As in the quarterly period, the 1997 nine month period reflects a $100 decrease in the average unit selling price which resulted in flat sales on higher unit volumes. Licensing and product development fee income decreased by $276,425 or 51% in the three months ended September 30, 1997 and increased by $6,767 or less than 1% in the nine months ended September 30, 1997 compared to the same periods in 1996. Fee income decreased in the quarterly period due to the fact that fewer development projects were generating fee income in the third quarter of 1997 than in the third quarter of 1996. The Company expects that licensing and product development fee income will fluctuate on a quarter to quarter basis, depending on a variety of factors. These factors include the timing of the execution of new development and licensing agreements and the timing, nature and size of fee payments to be made under existing and new agreements. In addition, since the Company does not, in general, recognize project-based fee income until related development work has been performed, quarterly results will fluctuate with the timing of the Company's research and development efforts. Cost of sales in the three and nine months ended September 30, 1997 were $263,114 and $811,122, respectively. These figures reflect increases of $39,924 or 18% and $86,214 or 12% over the three and nine month periods of the prior year, respectively. With unit volumes approximately flat in the quarterly periods, the expense increase for these periods relates in part to the Company's product recall initiated in September 1997. The recall resulted in excess product scrap expense and an interruption of normal production activities during the month of September 1997. In the nine month periods, the increase in expense can be attributed to a 25% increase in unit volume in addition to an increase in manufacturing overhead costs of approximately $100,000 in 1997. The largest individual components of this increase were higher tooling amortization costs and higher facilities costs. 7 Research and development expenses decreased by 24% to $556,866 in the three months ended September 30, 1997, from $730,308 during the same period in 1996. The decrease in expenses in the 1997 period is attributable to the transition of engineering efforts from heavy reliance on outside engineering service firms to lower cost internally staffed resources. Research and development expenses totaling $1,899,300 in the nine months ended September 30, 1997 were approximately unchanged from the prior year period. General and administrative expenses totaled $437,773 and $1,283,260 in the three and nine months ended September 30, 1997. In comparison to the prior year, these figures reflect increases of $144,395 or 49% and $317,803 or 33%, in the three and nine months ended September 30, 1997, respectively. The majority of the increases during the 1997 periods can be attributed to two principal factors. The largest one relates to various expenses of being a publicly traded company including; increased travel, legal, accounting and insurance expenses. The second major factor is increased patent rights amortization expenses. Sales and marketing expenses totaled $401,385 and $1,167,370 in the three and nine months ended September 30, 1997, respectively. These figures reflect year to year increases of $128,942 or 47%, and $428,047 or 58%, in the three and nine months ended September 30, 1997, respectively. These increases are principally attributable to added promotional activities in the U.S. diabetes market. Net other income (expense), increased by $104,039 and $303,892 relative to the prior year in the three and nine month periods ended September 30, 1997, respectively. These increases are attributable to both increased interest income as a result of higher cash balances and lower interest expense due to lower overall indebtedness in the 1997 periods. Higher cash balances are the result of an initial public offering completed in October 1996. Liquidity and Capital Resources Cash, cash equivalents and marketable securities totaled $11,039,517 on December 31, 1996 compared to $8,404,434 on September 30, 1997. The decrease results primarily from an operating loss of $2,327,140 in addition to an increase of $645,472 in fixed assets. The Company's long term capital requirements will depend on numerous factors, including the status of the Company's collaborative arrangements, the progress of the Company's research and development programs and the receipt of revenues from sales of the Company's products. The Company believes that cash on hand, interest expected to be earned thereon and anticipated revenues, will meet its needs through the next twelve months. In order to meet its capital needs beyond this period, the Company may be required to raise additional capital through public or private offerings, including equity offerings. 8 PART II - OTHER INFORMATION Item 1. Legal Proceedings. None. Item 2. Changes in Securities (Use of proceeds from public offering) The Company's initial Registration Statement on Form S-1, file no. 333- 6661, was declared effective by the Securities and Exchange Commission on October 10, 1996. The offering of the Company's Common Stock covered by such Registration Statement commenced on October 2, 1996. Rodman & Renshaw and R.J. Steichen & Company acted as the managing underwriters ("the Representatives") for the offering. A total of 2,750,000 shares of Common Stock, including 330,000 shares subject to the Representatives over-allotment option and 220,000 shares subject to the warrants issued to the Representatives were registered. In addition, warrants to purchase 220,000 shares of Common Stock issued to the Representatives were also registered. The aggregate offering price of the registered Common Stock and warrants was $15,367,220. Of this amount, $12,100,220 representing 2,200,000 shares of Common Stock and warrants to purchase 220,000 shares of Common Stock have been sold. The underwriter's over-allotment option has expired and these shares were not sold. The Representative's warrant has not yet been exercised and consequently the offering has not yet terminated. The amount of expenses incurred for the Company's account in connection with the issuance and distribution of the securities registered are as follows: Underwriting discounts and commissions:........ $ 907,500 Finder's fees.................................. 0 Expenses paid to or for the underwriters:...... 12,786 Other expenses:................................ 551,765 ---------- Total expenses............................ $1,472,050 All such expenses were paid directly or indirectly to others. The net offering proceeds to the Company after deducting expenses were $10,628,170. 9 The amount of net offering proceeds to the Company used for the following purposes is as follows: Purchase and installation of machinery and equip.... $ 759,852 Repayment of indebtedness........................... 123,130 Working capital..................................... 638,236 Temporary investments, marketable securities........ 4,998,897 Other : -market development expenses...... 1,447,124 -product development expenses..... 2,660,711 All such payments were made directly or indirectly to others. The use of proceeds contained herein does not represent a material change in the use of proceeds described in the prospectus. Item 3. Defaults Upon Senior Securities. None Item 4. Submission of Matters to a Vote of Securities Holders. None Item 5. Other Information. None Item 6. Exhibits and Reports on Form 8-K. (a) Exhibits 3.1 Second Amended and Restated Articles of Incorporation of the Company.(a) 3.2 Second Amended and Restated Bylaws of the Company.(a) 4.1 Form of Certificate for Common Stock.(a) 4.2 Stock Warrant, dated January 25, 1996, issued to Becton Dickinson and Company.(a) 4.3 Stock Option, dated January 25, 1996, issued to Becton Dickinson and Company.(a) 4.4 Warrant, dated March 24, 1995, issued to Robert Fullerton.(a) 4.5 Warrant, dated March 24, 1995, issued to Michael Trautner.(a) 10 4.6 Preferred Stock, Option and Warrant Purchase Agreement, dated January 25, 1996, between the Company and Becton Dickinson and Company (filed herewith as Exhibit 10.7).(a) 10.1 Office/Warehouse/Showroom Lease, dated January 2, 1995, including amendments thereto.(a) 10.3 Security Agreement, dated September 30, 1994, by and between the Company and Kelsey Lake Limited Partnership and Kerry Lake Company, a Limited Partnership.(a) 10.4 Promissory Note, dated September 30, 1994, issued to Kelsey Lake Limited Partnership.(a) 10.5 Promissory Note, dated September 30, 1994, issued to Kerry Lake Company, a Limited Partnership.(a) 10.6 Loan Agreement, dated as of December 22, 1995, by and between Ethical Holdings plc and the Company, including the related Promissory Note, dated December 22, 1995, issued to Ethical Holdings plc.(a) 10.7 Preferred Stock, Option and Warrant Purchase Agreement, dated January 25, 1996, between the Company and Becton Dickinson and Company.(a) 10.8 * Employment Agreement, dated as of January 1, 1997, between the Company and Franklin Pass, MD. (c) 10.9 * Employment Agreement, dated as of January 3, 1995, between the Company and Mark Derus.(a) 10.10* Employment Agreement, dated as of January 3, 1995, between the Company and Todd Leonard.(a) 10.11* Employment Agreement, dated as of January 3, 1995, between the Company and Peter Sadowski.(a) 10.12* 1993 Stock Option Plan.(a) 10.13* Form of incentive stock option agreement for use with 1993 Stock Option Plan.(a) 10.14* Form of non-qualified stock option agreement for use with 1993 Stock Option Plan.(a) 10.15* 1996 Stock Option Plan, with form of stock option agreement.(a) 11 +10.20 Development and License Agreement between Becton Dickinson and Company and the Company, effective January 1, 1996.(a) 10.21 Office-Warehouse lease with Carlson Real Estate Company, dated February 11, 1997. (b) 27 Financial Data Schedule * Indicates management contract or compensatory plan or arrangement. + Pursuant to Rule 406 of the Securities Act of 1933, as amended, confidential portions of Exhibit 10.20 were deleted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment, which was subsequently granted by the Securities and Exchange Commission. (a) Incorporated by reference to the Company's Registration Statement on Form S-1 (File No. 333-6661), filed with the Securities and Exchange Commission on October 1, 1996. (b) Incorporated by reference to the Company's Form 10-K for the year ended December 31, 1996. (c) Incorporated by reference to the Company's Form 10-Q for the quarter ended March 31, 1997. (b) Reports on Form 8-K No reports on Form 8-K were filed during the quarter ended September 30, 1997. 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. MEDI-JECT CORPORATION November 10, 1997 /s/ Franklin Pass - ---------------------------------- --------------------------------------- Date Franklin Pass, MD, Chairman/CEO November 10, 1997 /s/ Mark S. Derus - ---------------------------------- --------------------------------------- Date Mark S. Derus, Vice President Finance, CFO Principal Financial & Accounting Officer 12