SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q/A Amendment No. 1 X Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended SEPTEMBER 30, 1999 or ___ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the Transition Period from to ___ COMMISSION FILE NUMBER 0-18962 CYGNUS, INC. (Exact name of registrant as specified in its charter) DELAWARE 94-2978092 (State or other jurisdiction of (I.R.S. employer incorporation or organization) identification No.) 400 PENOBSCOT DRIVE, REDWOOD CITY, CALIFORNIA 94063-4719 (Address of principle executive offices and zip code) Registrant's telephone number, including area code: (650) 369-4300 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 ____ Number of shares outstanding of each of the registrant's classes of common stock as of OCTOBER 28, 1999: Common Stock, $.001 par value - 24,773,821 shares CYGNUS, INC. INDEX PART I. FINANCIAL INFORMATION PAGE NO. Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations......................................................................11 PART II. OTHER INFORMATION Item 6: Exhibits and Reports on Form 8-K..............................................................28 SIGNATURES...................................................................................................32 Cygnus, Inc. September 30, 1999 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS THIS REPORT ON FORM 10-Q CONTAINS FORWARD-LOOKING STATEMENTS, INCLUDING, BUT NOT LIMITED TO, THOSE SPECIFICALLY IDENTIFIED AS SUCH, THAT INVOLVE RISKS AND UNCERTAINTIES. THE STATEMENTS CONTAINED IN THIS REPORT ON FORM 10-Q THAT ARE NOT PURELY HISTORICAL ARE FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE SECURITIES ACT AND SECTION 21E OF THE EXCHANGE ACT, INCLUDING WITHOUT LIMITATION STATEMENTS REGARDING OUR EXPECTATIONS, BELIEFS, INTENTIONS OR STRATEGIES REGARDING THE FUTURE. ALL FORWARD-LOOKING STATEMENTS INCLUDED IN THIS REPORT ON FORM 10-Q ARE BASED ON INFORMATION AVAILABLE TO US ON THE DATE HEREOF, AND WE ASSUME NO OBLIGATION TO UPDATE ANY SUCH FORWARD-LOOKING STATEMENTS. OUR ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE ANTICIPATED IN THESE FORWARD-LOOKING STATEMENTS AS A RESULT OF A NUMBER OF FACTORS, INCLUDING, BUT NOT LIMITED TO, THOSE SET FORTH IN THE "RISK FACTORS" CONTAINED IN THIS MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS AND ELSEWHERE IN THIS REPORT ON FORM 10-Q. GENERAL We are engaged in the development and manufacture of diagnostic and drug delivery systems, utilizing proprietary technologies to satisfy unmet medical needs cost-effectively. Our efforts are primarily focused on two core areas: a frequent, automatic and non-invasive glucose monitoring device (the GlucoWatch - Registered Trademark - monitor) and transdermal drug delivery systems. From time to time, we consider strategic transactions and alternatives relating to our drug delivery business, with the goal of providing additional funding for the development of the GlucoWatch - Registered Trademark - monitor. These alternatives include, among others, the divestiture of all or part of the drug delivery business. We will continue to evaluate strategic transactions and alternatives which we believe may enhance stockholder value. On January 25, 1999 the Company submitted the first part of the Pre-Market Approval Application ("PMA") for the GlucoWatch - Registered Trademark - monitor to the FDA. This submission included a variety of information, including manufacturing documentation. We submitted the remainder of the PMA in June 1999, including analysis of a series of clinical studies totaling more than 600 people which were completed in December 1998, as well as two additional studies. The FDA notified the Company in July 1999 that the PMA for the GlucoWatch - Registered Trademark - monitor had been deemed suitable for filing. The FDA also granted expedited review status to the GlucoWatch -Registered Trademark - monitor and has since stated that the GlucoWatch -Registered Trademark - monitor will be reviewed by the Clinical Chemistry and Toxicology Devices Panel on December 6, 1999. Although we believe its 11 Cygnus, Inc. September 30, 1999 clinical results to date are encouraging, no assurance can be given that data generated in the clinical studies to date will provide a sufficient basis for the approval of the GlucoWatch - Registered Trademark - monitor by the FDA. We are currently involved in discussions with a short list of companies with regard to a collaboration for the marketing and distribution of the GlucoWatch - Registered Trademark - monitor in the United States, Europe and those territories not included in the agreement between us and Tokyo-based Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi"). (For more on the Yamanouchi agreement see "Contract Revenue," under Results of Operations.) There can be no assurance that we will be able to enter into such a collaboration agreement. In 1998, Cygnus entered into long term agreements with E.I. du Pont de Nemours & Company ("DuPont") for the development and supply of thick film materials for Cygnus' GlucoWatch - Registered Trademark - monitor. A key component of the GlucoWatch -Registered Trademark - monitor is the sensor, which we developed with DuPont's materials. The agreements call for continued cooperation for future sensor technology developments and continued supply of materials. On September 30, 1999, we entered into a Manufacturing and Supply Agreement and Amendment thereto with LTS Lohmann Therapy Systems Corp. ("LTS Corp"), wherein LTS Corp will manufacture the majority of the contraceptive transdermal patch (the Evra -Trademark - Johnson & Johnson, New Brunswick, New Jersey - System) that Cygnus is developing for Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company. In addition to the Manufacturing and Supply Agreement, Cygnus and LTS Corp entered into a Side Letter to said Agreement of the same date that describes additional manufacturing capacity needs, equipment costs and liabilities, estimated to represent a risk of $US 27,600,000 of which we will be liable for one-third (1/3) of this risk until bioequivalency of the EVRA-TM- system has been established and thereafter we will be liable for one-half (1/2) of this risk. This risk is reduced as certain minimum volumes of the EVRA-TM- system are produced, and we believe that sufficient funds are available if such minimums are not reached and risk payments must be made. Our product development efforts have been and are expected to continue to be either self-funded, funded by licensees or distributors, or both. In general, our agreements provide that we will manufacture our products and receive manufacturing revenues from sales of these products to our licensees or distributors. We may also receive royalties based on certain of our licensees' or distributors' product sales. In certain circumstances, we may elect to license manufacturing rights for a product to our licensee in exchange for a technology transfer fee and/or a higher royalty rate. Our licensees and distributors generally have the right to abandon a product development effort at any time for any reason without significant penalty. Such cancellations may result in delays, suspension or abandonment of clinical testing, the preparation and processing of regulatory filings, and product development and commercialization efforts. Licensees have exercised this right in the past, and there can be no assurance that current and future licensees or distributors will not exercise this right in the future. If a licensee or distributor were to cease funding one of our products, we would either self-fund development efforts, identify and enter into an agreement with an alternative licensee or distributor or suspend further development work on the product. There can be no assurance that, if necessary, we would be able to negotiate an agreement with an alternative licensee or distributor on acceptable terms. Since all payments to us under our agreements are contingent on the occurrence of future events or sales levels, and the agreements are terminable by the licensee or distributor, no assurance can be given as to 12 Cygnus, Inc. September 30, 1999 whether we will receive any particular payment thereunder or as to the amount or timing of any such payment. In the past some of our licensees, distributors and collaborators have approached us requesting modification of the terms of existing agreements. We may choose to self-fund certain research and development projects in order to exploit our technologies. Any increase in Company-sponsored research and development activities will have an immediate adverse effect on our results of operations. However, should such Company-sponsored research and development activities result in a commercial product, the long-term effect on our results of operations could be favorable. To remain competitive, we will need to develop, in-license or acquire new diagnostic products. Furthermore, our ability to develop and commercialize products in the future will depend on our ability to enter into collaboration arrangements with additional licensees on favorable terms. There can be no assurance that we will be able to enter into new collaboration arrangements on such terms, if at all. Our results of operations vary significantly from year to year and quarter to quarter and depend on, among other factors, the signing of new product development agreements and the timing of recognizing payment amounts specified thereunder, the timing of recognizing license or distribution fees and cost reimbursement payments made by pharmaceutical licensees, and the demand for such products. Up-front and interim milestone payments from contracts are generally earned and recognized based on the percentage of actual efforts expended compared to total expected efforts during the development period for each contract. However, contract revenues are not always aligned with the timing of related expenses. To date, our research and development expenses have generally exceeded contract revenue in any particular period and we expect the same situation to continue for the next few years. In addition, the level of revenues in any given period is not necessarily indicative of expected revenues in future periods. We have incurred net losses each year since our inception and do not believe we will achieve profitability in 1999. At September 30, 1999, our accumulated deficit and net capital deficiency were approximately $191.9 million and $19.4 million, respectively. RESULTS OF OPERATIONS: COMPARISON FOR THE QUARTERS ENDED SEPTEMBER 30, 1999 AND 1998 PRODUCT REVENUES. There were no product revenues for the quarter and nine months ended September 30, 1999 or for the quarter ended September 30, 1998. Product revenues for the nine months ended September 30, 1998 were $0.6 million. These revenues resulted from the shipments of the FemPatch - Registered Trademark - (Warner-Lambert Co., Morris Plains, NJ) system during the first half of 1998. The reduction in total product revenues is due to the discontinuation of shipments of the FemPatch - Registered Trademark - system. The FemPatch - Registered Trademark - system, commercially launched in 1997, is a low-dose, 7-day estrogen replacement transdermal patch for the treatment of menopausal symptoms. Sanofi S.A. ("Sanofi"), our worldwide licensee, had sublicensed U.S. marketing rights to Warner-Lambert. In November 1998, Warner-Lambert terminated its agreement with Sanofi, which also terminated the Supply Agreement between Warner-Lambert and Cygnus. Consequently, the product is no longer being marketed. 13 Cygnus, Inc. September 30, 1999 Due to the above factors and the uncertainty regarding when and if additional products will obtain approval from the FDA and when and if licensees will sell and market such products, we believe that the level of product revenues experienced to date is not indicative of future results and may fluctuate from period to period. CONTRACT REVENUES for the quarter ended September 30, 1999 were $3.9 million compared to $2.5 million for the quarter ended September 30, 1998 and were $10.3 million for the nine months ended September 30, 1999 compared to $7.8 million for the nine months ended September 30, 1998. Contract revenues primarily reflect labor and material cost reimbursements associated with the development of certain transdermal delivery systems and the amortization of milestone payments related to certain transdermal delivery systems and the glucose monitoring device. The increase in contract revenues for the three months ended September 30, 1999 is primarily due to the increased development billings related to the contraception product we are developing with Ortho-McNeil Pharmaceutical, Inc., a division of Johnson & Johnson and the amortization of a previously capitalized milestone payment received from Yamanouchi for the GlucoWatch(R) monitor. The increase in contract revenues for the nine months ended September 30, 1999 is primarily due to the acceleration of the amortization of a previously deferred milestone payment of $1.8 million received from American Home Products Corporation ("AHP"), acting through its Wyeth-Ayerst division. This acceleration resulted from AHP's notification to us that AHP would not be exercising its option to reacquire rights under the amendment to the Agreement discussed below. Additional reasons for the increase in contract revenue for the nine months ended September 30, 1999 were increased development billings related to the contraception and nicotine patch products and the amortization of a milestone payment received from Yamanouchi in July 1999, as mentioned below. By way of background for the AHP agreement, in December 1998, a New Drug Application ("NDA") was submitted to the FDA and the European Dossier was submitted to the European authorities for our 7-day estrogen patch. In July 1998, we were notified by AHP, the licensee for two of our transdermal hormone replacement products, including our 7-day estrogen patch, that AHP wanted to discuss the status of its agreements with us and that it intended to exercise its right under the agreements to seek a sublicensee for the products. In November 1998, we negotiated with AHP an amendment to the agreements that provided us immediate ownership of the regulatory filing packages for the two products and the right to co-promote the two products as well. The amendment also provided that, if AHP was unable to sign an agreement with a sublicensee or opted not to reacquire its rights within six months, the rights to the two products would revert to Cygnus. However, AHP would still be obligated to continue development activities for the two products for an additional six months. In June 1999, AHP notified us that a sublicense agreement was not signed and that AHP would not be exercising its option to reacquire rights, but that it would support development activities until mid-November 1999 pursuant to the amendment. In September 1999, our 7-day estrogen patch was cleared for marketing by the FDA. We have not decided on any course of action with regard to these two products, and AHP's support will cease on November 17, 1999. Regarding our contraception product, in 1994, Cygnus entered into an agreement with Ortho-McNeil Pharmaceutical Inc. ("Ortho"), a Johnson & Johnson company, for the development of a 7-day contraceptive patch, the EVRA(TM) (Johnson & Johnson, New Brunswick, NJ) system. 14 Cygnus, Inc. September 30, 1999 Ortho has exclusive worldwide marketing rights to the product. Cygnus has received up-front payments and will receive milestone payments as well as a percentage of net sales, if and when the product is commercialized, and is responsible for the development and manufacture of the product. Phase 3 clinical trials for this product have been completed. Also, in July 1996, we entered into an agreement with Tokyo-based Yamanouchi Pharmaceutical Co., Ltd. ("Yamanouchi") for the marketing and distribution of the GlucoWatch - Registered Trademark - monitor. Under the terms of this agreement, Yamanouchi has exclusive marketing and distribution rights in Japan and Korea. We have primary responsibility for completing product development and for manufacturing. In the third quarter of 1996, we received an up-front, non-refundable payment from Yamanouchi. In July of 1999, we received a non-refundable milestone payment from Yamanouchi which is being amortized, and we are eligible to receive further milestone payments as well as a percentage of the product's future commercial sales. Additionally, in 1998, we entered into an agreement with an undisclosed company for the development, supply and commercialization of a nicotine transdermal system, a smoking cessation patch being developed by Cygnus. Under the terms of the agreement, the undisclosed company has marketing and distribution rights in certain territories. We have exclusive manufacturing and supply rights. The undisclosed company has primary responsibility for obtaining regulatory approval and commercialization. We have received payments for 1999 and 1998 manufacturing and development costs. In September 1999, Cygnus was awarded a Phase I Small Business Innovative Research (SBIR) grant for "High Performance Biosensor Electrode Materials" from the National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health (NIH). Contract revenues are expected to fluctuate from quarter to quarter and from year to year, and future contract revenues cannot reasonably be predicted. The contributing factors to achieving contract revenues include, but are not limited to, future successes in finalizing new collaboration agreements, timely achievement of milestones under current contracts, and strategic decisions on self-funding certain projects. We are unable to predict to what extent the termination of existing contracts by current partners or new collaboration agreements, if any, will impact overall contract revenues in the remainder of 1999 and future periods. ROYALTY AND OTHER REVENUES for the quarter ended September 30, 1999 were $0.4 million compared to $0.3 million for the quarter ended September 30, 1998 and were $1.0 million for the nine months ended September 30, 1999 compared to $0.7 million for the nine months ended September 30, 1998. The amounts reflect royalties from worldwide sales by Pharmacia & Upjohn ("Pharmacia") of the Company's nicotine transdermal product, the Nicotrol - Registered Trademark (Pharmacia AB, Stockholm, Sweden) - system. The Company's Nicotrol - Registered Trademark - product was initially introduced in the U.S. as a prescription product in 1992 and subsequently approved for over-the-counter sale in the U.S. in 1996. The Nicotrol -Registered Trademark - patch is currently marketed in North America by Ortho-McNeil Pharmaceutical, Inc., a Johnson & Johnson company and in many 15 Cygnus, Inc. September 30, 1999 European countries by Pharmacia. Cygnus receives royalties on the worldwide sales of the Nicotrol - Registered Trademark - patch. Royalty revenues will fluctuate from period to period, since they are primarily based upon sales by our licensees. The level of royalty income for a product also depends on various external factors, including the size of the market for the product, product pricing levels and the ability of our licensees to market the product. Therefore, the level of royalty revenues for any given period is not indicative of the expected royalty revenues for future periods. COSTS OF PRODUCTS SOLD for the quarter ended September 30, 1999 were $0.0 million compared to $0.7 million for the quarter ended September 30, 1998 and were $0.0 million for the nine months ended September 30, 1999 compared to $2.7 million for the nine months ended September 30, 1998. Costs of products sold primarily include direct and indirect production, and facility and personnel costs required to meet anticipated production levels. The decrease in costs of products sold for the three and nine months ended September 30, 1999 is due to the discontinuation of shipments of the FemPatch - - Registered Trademark -system as a result of the termination of the FemPatch - - Registered Trademark -system supply agreement. Cost of products sold for the nine months ended September 30, 1998 include shipments of the FemPatch Registered Trademark -system in the first half of 1998. We do not have any product revenue or costs of products sold for the three and nine months ended September 30, 1999 as a result of the aforementioned discontinuation, and we experienced negative production margins for the three and nine months ended September 30, 1998 due to low production volumes that prevented us from absorbing all of our fixed manufacturing costs. RESEARCH AND DEVELOPMENT EXPENSES for the quarter ended September 30, 1999 were $5.8 million compared to $7.9 million for the quarter ended September 30, 1998 and were $19.3 million for the nine months ended September 30, 1999 compared to $22.7 million for the nine months ended September 30, 1998. The decrease in research and development expenses for the three and nine months ended September 30, 1999 is primarily due to decreased costs of clinical studies associated with the GlucoWatch - Registered Trademark - monitor. Research and development and clinical activities primarily include support and development for the glucose monitoring program, the contraceptive product, and hormone replacement therapy products. MARKETING, GENERAL AND ADMINISTRATIVE EXPENSES for the quarter ended September 30, 1999 were $1.7 million compared to $3.6 million for the quarter ended September 30, 1998 and were $5.2 million for the nine months ended September 30, 1999 compared to $8.4 million for the nine months ended September 30, 1998. The decrease is primarily due to reduced legal and compensation expenses. INTEREST INCOME/(EXPENSES), NET for the quarter ended September 30, 1999 were $(0.8) million compared to $(0.2) million for the quarter ended September 30, 1998 and were $(2.7) million for the nine months ended September 30, 1999 compared to $(0.2) million for the nine months ended September 30, 1998. The increase in net interest expense is due primarily to the write down of the remaining unamortized debt issuance costs associated with the Senior Subordinated Convertible Notes Agreement entered into in February 1998. In addition, interest income earned has decreased in conjunction with the decrease in the cash and cash equivalents balance. 16 Cygnus, Inc. September 30, 1999 LIQUIDITY AND CAPITAL RESOURCES Through December 1998, we received net proceeds of approximately $95.4 million from public offerings of our Common Stock. Through December 1998, we financed approximately $11.1 million of manufacturing and research equipment under capital loan and lease arrangements. Borrowings under those arrangements are secured by specific Company assets. In April 1998, we consolidated our two outstanding bank loans into an expanded credit facility with the same bank. An additional $4.7 million was borrowed, increasing the total outstanding under the new agreement to $10.0 million. In November of 1998, the April agreement was further amended to modify the covenants. This balance will be repaid through November 2001, with monthly interest-only payments through November 1998 and monthly principal-and-interest installments thereafter. As of September 30, 1999 there was $6.3 million outstanding under this agreement. Borrowings under this agreement are secured by specific Company assets. In February 1998, we entered into Note Purchase Agreements with certain institutional Investors to issue and sell approximately $43.0 million of 4% Senior Subordinated Convertible Notes Due 2005 (the "Notes"). On October 28, 1998, we restructured the Notes. Key provisions in the restructured Notes include the October 1998 repayment of $18.5 million in principal (reducing the principal balance from $43.0 million to $24.5 million), a delay in the convertibility of the majority of the Notes to September 30, 1999, modification of conversion prices of the Notes, the ability of the Company to redeem at par at any time all or part of the new principal amount of the Notes, an increase in the interest rate to 5.5% paid annually on the new principal balance and a change in the final maturity of the Notes to October 1, 2000. Through June 30, 1999, $6.0 million was converted into Common Stock at a price of $3.54 per share and $6.0 million was converted into Common Stock at a price of $6.89 per share. The remaining $12.5 million and accrued interest were redeemed in July 1999. In June 1999, we entered into agreements with certain institutional Investors to issue and sell up to $20 million aggregate principal amount of 8.5% Convertible Debentures Due September 29, 2004. On June 30, 1999 we also entered into an Equity Line Agreement. The Equity Line is effective for two years and allows us, at our sole discretion, to sell shares of Cygnus Common Stock with a maximum aggregate sales price of up to $30.0 million. As of June 30, 1999, we received gross proceeds of $14.0 million from the issuance of 8.5% Convertible Debentures and $4.0 million from the sale of Common Stock under the Equity Line. On September 29, 1999, we received $4.0 million ("Additional Investment") pursuant to an amendment to the Equity Line agreement. We issued 361 thousand shares of Common Stock in exchange for the Additional Investment subject to adjustment upwards at the end of 110 trading days after September 29, 1999. Also on September 29, 1999, we received $3.0 million in gross proceeds from the issuance of the first Additional Tranche due September 29, 2004 pursuant to the terms of the Convertible Debentures purchase agreement. (See Note 6 to the financial statements contained in this report.) 17 Cygnus, Inc. September 30, 1999 In June 1999, we opened a standby letter of credit ("LC") for $0.9 million in favor of our lessor to maintain compliance with our capital lease agreement. To secure this standby LC, we pledged a certificate of deposit, which is considered restricted cash, to the issuing bank. The certificate of deposit earns interest at a rate yielding 4.19% per annum. In addition to the cash received from the public offerings, issuance of the Notes, Equity Line, equipment lease and short-term working capital financing, we have financed our operations primarily through revenues and interest income. Net cash used in operating activities for the nine months ended September 30, 1999 was $14.2 million compared with net cash used of $36.0 million for the nine months ended September 30, 1998. Cash used in operating activities during the nine months ended September 30, 1999 was primarily due to our net loss of $15.9 million and decreases in provision for doubtful accounts of $2.0 million, deferred compensation and other assets of $4.2 million and accountants payable and other accrued liabilities of $2.1 million, offset by decreases in notes receivable, prepaid expenses and other current assets of $4.1 million, accounts receivable of $1.5 million and inventories of $0.8 million and increases in depreciation and amortization of $1.3 million, amortization of debt issuance cost of $1.1 million, deferred revenue of $1.0 million and accrued compensation of $0.7 million. Cash used in operating activities during the nine months ended September 30, 1998 was primarily due to our net loss of $24.8 million and a $14.0 million cash payment made in January 1998 to Sanofi under the terms of the arbitration settlement, offset by an increase in accounts payable and other accrued liabilities of $0.7 million, a decrease in notes receivable, prepaid expenses and other current assets of $0.8 million and a decrease in accounts receivable of $0.7 million. The current level of cash used in operating activities is not necessarily indicative of the level of future cash usage. We expect a decrease in operating cash usage for 1999 compared to 1998 primarily due to the $14.0 million payment in 1998 of the Sanofi arbitration liability, which will not recur in 1999. Net cash provided by investing activities of $12.4 million for the nine months ended September 30, 1999 resulted primarily from net sales of investments of $14.7 million, offset by capital expenditures of $2.2 million. Net cash used in investing activities of $24.6 million for the nine months ended September 30, 1998 resulted primarily from net purchases of short-term investments of $22.0 million and capital expenditures of $2.6 million. Net cash provided by financing activities of $9.7 million for the nine months ended September 30, 1999 includes, as mentioned above, gross proceeds of $17.0 million and $8.0 million from the June 1999 and September 1999 issuance of 8.5% Convertible Debentures and from the sale of Common Stock under the Equity Line, respectively, and additional stock proceeds of $2.5 million, offset by the July 1999 redemption of Senior Subordinated Convertible Notes of $12.5 million, long-term debt of $4.1 million and capital lease repayments of $0.3 million. Net cash provided by financing activities of $58.7 million for the nine months ended September 30, 1998 includes net proceeds of $40.4 million and $13.3 million from the Company's February 1998 issuance of Senior Subordinated Convertible Notes and from a direct public offering of its Common Stock, respectively, additional stock proceeds of $0.9 million and $6.1 18 Cygnus, Inc. September 30, 1999 million from the issuance of long-term debt, offset by long-term debt and capital lease repayments of $1.6 million and $0.4 million, respectively. Our long-term capital expenditure requirements will depend upon numerous factors, including the progress of our research and development programs; the time required to obtain regulatory approvals; the resources that we devote to the development of self-funded products, proprietary manufacturing methods and advanced technologies; our ability to obtain additional licensing arrangements and to manufacture products under those arrangements; the additional expenditures to support the manufacture of new products, if and when approved; and possible acquisitions of products, technologies and companies. As we evaluate the progress of our development projects, in particular the GlucoWatch - Registered Trademark monitor, our commercialization plans and the lead time to set up manufacturing capabilities, we may commence long-term planning for another manufacturing site. Nevertheless, we believe that such long-term planning will not result in any material impact on cash flows and liquidity for the next twelve months. Based upon current expectations for operating losses and projected short-term capital expenditures, we believe that existing unrestricted cash, cash equivalents and investments of $21.9 million as of September 30, 1999 -- when coupled with cash from revenues and other funding, such as from potential product funding collaborations or from public financings (including debt or equity financings) and earnings from investments -- will be sufficient to meet our operating expenses, debt servicing and repayments and capital expenditure requirements at least through September 30, 2000. However, there can be no assurance that we will not require additional financing, depending upon future business strategies, results of clinical trials and management decisions to accelerate certain research and development programs and other factors. YEAR 2000 COMPLIANCE We are preparing for the impact of the arrival of the Year 2000 ("Y2K") on our business, as well as on the businesses of our customers, suppliers and business partners. The "Y2K Issue" is a term used to describe the problems created by systems that are unable to accurately interpret dates after December 31, 1999. These problems are derived predominantly from the fact that many software programs have historically categorized the "year" in a two-digit format. The Y2K Issue creates potential risks for Cygnus, including potential problems in our products as well as in the Information Technology ("IT") and non-IT systems that we use in our business operations. We may also be exposed to risks from third parties with whom we interact who fail to adequately address their own Y2K Issues. We began our Y2K efforts early in 1998 by forming a project office chaired by the Senior Vice President of Finance. The Board of Directors is advised periodically on the status of our Y2K compliance program. The project team developed a five-phase approach to identifying and remediating Y2K Issues. These phases are: 1. Awareness 19 Cygnus, Inc. September 30, 1999 2. Inventory 3. Assessment 4. Correction and Testing 5. Implementation We completed the awareness phase of the project in the third quarter of 1998. This phase consisted of meetings with our personnel to educate them on the issues related to Y2K. The meetings focused on internal systems, both IT and non-IT, as well as external systems and relationships. We engaged the services of an outside Y2K consulting service to perform a comprehensive inventory of internal IT and non-IT systems and applications. The inventory was completed during the fourth quarter of 1998. Concurrent with the inventory, our consultant performed an assessment of the systems and applications documented in the inventory. The result of this independent assessment showed that the majority of our internal IT systems were compliant. This is due to the fact that we do not rely on in-house-developed applications for our core business applications and therefore do not have legacy code to review and test. Our core business applications (Accounts Payable, Accounts Receivable, Sales Orders and Inventory Control) are supported by an application that has been certified by the supplier to be fully Y2K compliant and the compliance has been tested by us. Additionally, we use a third party application for tracking our Intellectual Property assets. This application has been certified by the vendor to be fully compliant. The assessment did determine that the payroll application in use was non-compliant. This was upgraded to a compliant version in the first quarter of 1999. Due to the regulatory requirements placed on the pharmaceutical and medical device industry by the FDA, we have placed appropriate attention on the non-IT systems. For us, this specifically covers all areas governed by current Good Manufacturing Practice ("cGMP") guidelines and includes but is not limited to environmental monitoring/control systems, laboratory instrumentation and their sub-systems, production equipment, and materials handling equipment. The assessment identified several of these non-IT systems to be non-compliant. The majority of these non-compliant systems are laboratory instrumentation and their sub-systems. These systems are assessed to be non-mission critical. We fully expect that these systems will be upgraded or replaced or have a contingency plan in place by January 1, 2000. Concurrent with the inventory and assessment of internal systems and applications, we identified several providers of products and services that are critical to our operations. We are working with these providers to ensure that these critical products and services are available for continued operations after January 1, 2000. At this time we are not aware of any issues relating to these providers. The correction and testing, as well as the implementation phases of our Y2K compliance programs are currently underway and are expected to be completed prior to January 1, 2000. The total cost associated with our Y2K remediation is not expected to be material to our financial condition or results of operations. 20 Cygnus, Inc. September 30, 1999 Through September 30, 1999 we have spent approximately $125,000 in connection with Y2K Issues and we have substantially completed our remediation efforts. The cost of implementing the replacement for our core business applications has not been included in this figure since the replacement of the previous applications was not accelerated due to Y2K Issues. All Y2K expenditures are made from the respective departments' budgets. Although we assess our Y2K Issue to be moderate to low, there can be no assurance that we will be completely successful in our efforts to address Y2K Issues. Having reasonably determined that our own hardware and software systems will be substantially Y2K compliant, management believes that the worst case scenarios would most likely involve simultaneous Y2K-related disruptions from our key customers, suppliers, service providers and/or other business partners. For these worst case scenarios to have maximum adverse impact on Cygnus, either the vendors in question would need to be sole-source providers, or their peer companies, who would otherwise be potential second-source suppliers, would also need to undergo similar Y2K-related disruption. We believe that such simultaneous disruptions of the supply of basic goods and services due to Y2K-related issues is unlikely to occur. Although we have not yet completed a comprehensive contingency plan to address situations that may result if we or any of the third parties upon which we are dependent are unable to achieve Y2K readiness, our Y2K compliance program is ongoing and its ultimate scope, as well as the consideration of contingency plans, will continue to be evaluated as new information becomes available. The foregoing Y2K discussion contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including, without limitation, anticipated costs and the dates by which we expect to complete certain actions, are based on management's best current estimates, which were derived utilizing numerous assumptions about future events, including the continued availability of certain resources, representations received from third parties and other factors. However, there can be no guarantee that these estimates will be achieved, and actual results could differ materially from those anticipated. Specific factors that might cause such material differences include, but are not limited to, the ability to identify and remediate all relevant IT and non-IT systems; results of Year 2000 testing; adequate resolution of Y2K Issues by businesses and other third parties who are service providers, suppliers or customers of Cygnus; unanticipated system costs; the adequacy of and ability to develop and implement contingency plans; and similar uncertainties. The forward-looking statements made in the foregoing Y2K discussion speak only as of the date on which such statements are made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statements are made or to reflect the occurrence of unanticipated events. RISK FACTORS WE WISH TO CAUTION STOCKHOLDERS AND INVESTORS THAT THE FOLLOWING IMPORTANT FACTORS, AMONG OTHERS, IN SOME CASES HAVE AFFECTED, AND IN THE FUTURE COULD AFFECT, OUR ACTUAL RESULTS AND COULD CAUSE OUR ACTUAL CONSOLIDATED RESULTS FOR 1999, AND BEYOND, TO DIFFER MATERIALLY FROM THOSE 21 Cygnus, Inc. September 30, 1999 EXPRESSED IN ANY FORWARD-LOOKING STATEMENTS MADE BY US OR ON BEHALF OF US. THE STATEMENTS UNDER THIS CAPTION ARE INTENDED TO SERVE AS CAUTIONARY STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. THE FOLLOWING INFORMATION IS NOT INTENDED TO LIMIT IN ANY WAY THE CHARACTERIZATION OF OTHER STATEMENTS OR INFORMATION UNDER OTHER CAPTIONS AS CAUTIONARY STATEMENTS FOR SUCH PURPOSE. WE HAVE INCURRED SUBSTANTIAL LOSSES AND ANTICIPATE CONTINUING LOSSES. We have a limited operating history to evaluate our prospects. You should consider our prospects in light of the substantial risks, expenses and difficulties encountered by companies entering into the medical device and drug delivery industry. We reported a net loss of $5.0 million for the quarter ended September 30, 1999 and have experienced annual operating losses since our inception. We expect to continue to incur operating losses at least until we have significant sales, if we ever do, of the GlucoWatch - Registered Trademark - monitor or the contraceptive patch. We cannot assure you that we will generate significant revenues or achieve profitability. We have, and expect to continue to have, fluctuations in quarterly results based on varying contract revenues and expenses associated with our contracts and collaboration projects. Some of these fluctuations could be significant. To date, we have generated limited revenues from product sales. We do not have significant experience in manufacturing, marketing or selling our products. Our future development efforts may not result in commercially viable products. We may fail in our efforts to introduce our products or to obtain required regulatory clearances. Our products may never gain market acceptance, and we may never generate revenues or achieve profitability. Our revenues to date have been derived primarily from: - product development and licensing fees related to our products under development, and - manufacturing and royalty revenues from the Nicotrol - Registered Trademark (Pharmacia AB, Stockholm, Sweden) nicotine patch and the FemPatch - Registered Trademark (Warner-Lambert Co., Morris Plains, NJ) - system. In the future, we will no longer receive manufacturing revenue from the Nicotrol - Registered Trademark - patch or the FemPatch - Registered Trademark -system. We will, however, continue to receive royalty payments for the Nicotrol Registered Trademark - patch. If we obtain regulatory approvals, we expect that a substantial portion of our future revenues will be derived from sales of the GlucoWatch - Registered Trademark - monitor and other diagnostic products currently under development. WE MAY NEED ADDITIONAL FINANCING AND IT MAY NOT BE AVAILABLE. To continue the development of our products, we will require substantial resources to conduct research and conduct preclinical development and clinical trials necessary to bring our products to market and to establish production and possibly marketing capabilities. We may seek additional funding through public or private financings, including debt or equity financings. We may also seek other arrangements, including collaboration arrangements. Any additional equity financings may dilute the holdings of current stockholders. Debt financing, if available, may 22 Cygnus, Inc. September 30, 1999 restrict our ability to issue dividends and take other actions. We may not be able to obtain adequate funds when we need them from financial markets or arrangements with corporate partners or other sources. Even if funds are available, they may not be on acceptable terms. If we cannot obtain sufficient additional funds, we may have to delay, scale back or eliminate some or all of our research and product development programs, or to license or sell products or technologies that we would otherwise seek to develop ourselves. From time to time, we consider strategic transactions and alternatives related to our drug delivery business, with the goal of providing additional funding for the development of the GlucoWatch - Registered Trademark - monitor. These alternatives include, among others, the divestiture of all or part of the drug delivery business. We will continue to evaluate strategic transactions and alternatives which we believe may enhance stockholder value. We believe that our existing cash, cash equivalents and investments, plus cash from revenues; other fundings, such as potential product funding collaborations or financings; and earnings from investments will suffice to meet our operating expenses, debt servicing and repayments and capital expenditure requirements at least through September 30, 2000. The amounts and timing of future expenditures will depend on: - - progress of ongoing research and development, - - results of preclinical testing and clinical trials, - - rates at which operating losses are incurred, - - executing any development and licensing agreements with corporate partners, - - developing our products, - - manufacturing scale-up for the GlucoWatch - Registered Trademark - monitor; - - the FDA regulatory process, and - - other factors, many of which are beyond our control. WE DEPEND ON LICENSEES, DISTRIBUTORS AND COLLABORATION ARRANGEMENTS. Our strategy to develop, clinically test, obtain regulatory approval for, manufacture and commercialize our products depends, in large part, upon our ability to selectively enter into and maintain collaboration arrangements with licensees and distributors. If we commercialize our GlucoWatch - Registered Trademark - monitor, we will depend upon Yamanouchi Pharmaceutical Co., Ltd. to market and distribute the GlucoWatch - Registered Trademark - monitor in Japan and Korea. We do not have any marketing or distribution agreements for the GlucoWatch - Registered Trademark - monitor other than the Yamanouchi collaboration. However, we are currently involved in discussions with a short list of companies about collaborating to market and distribute the GlucoWatch -Registered Trademark - monitor in the U.S., Europe and elsewhere outside Japan and Korea. 23 Cygnus, Inc. September 30, 1999 Our licensees and distributors generally have the right to terminate product development at any time before we are granted regulatory approval, for any reason and without significant penalty. These cancellations may cause us to delay, suspend or abandon our clinical testing, regulatory filings and product development and commercialization efforts. Licensees have exercised this right in the past, and we cannot assure you that current and future licensees or distributors will not exercise this right in the future. All payments to us under our licensing and distribution agreements depend on future events or sales levels, and the licensee or distributor may terminate these agreements. As a result, we cannot assure you when or if we will receive any particular payment. In the past, some of our licensees, distributors and collaborators have asked us to modify the terms of existing agreements. If a licensee or distributor stopped funding one of our products, we would either fund development efforts ourselves, enter into an agreement with an alternative licensee or distributor, or suspend further development work on the product. We cannot assure you that we would be able to negotiate an acceptable agreement with an alternative licensee or distributor. Additionally, we may choose to self-fund certain research and development projects in order to exploit our technologies. If these activities result in a commercial product, they will help our long-term operating results. However, any increase in self-sponsored research and development or sales and marketing activities will negatively affect our short-term operating results. Furthermore, we cannot control the resources and attention a licensee or distributor devotes to a product. As a result, we may experience delays in clinical testing, regulatory filings and commercialization efforts conducted by our licensees or distributors. We cannot assure you that our licensees or distributors will not, for competitive reasons, support, directly or indirectly, a company or product that competes with one of our products that is the subject of their license or distribution agreement with us. Furthermore, any dispute between us and one of our licensees or distributors might require us to initiate or defend against expensive litigation or arbitration proceedings. If one of our licensees or distributors terminates an arrangement, cannot fund or otherwise satisfy its obligations under its arrangements, or significantly disputes or breaches a contractual commitment, then we would likely be required to seek an alternative licensee or distributor. We cannot assure you that we would be able to reach agreement with a replacement licensee or distributor. If we were unable to find a replacement licensee or distributor, we might not be able to perform or fund the activities of the current licensee or distributor. Even if we were able to perform and fund these activities, our capital requirements would increase substantially. In addition, the further development and the clinical testing, regulatory approval process, marketing, distribution and sale of the product covered by such licensee or distributor would be significantly delayed. (See "Risk Factors - We Have Limited Marketing and Sales Experience.") For us to be competitive, we will need to develop, license or acquire new diagnostic products. Furthermore, our ability to develop and commercialize products in the future will depend, in part, on our ability to enter into collaboration arrangements with additional licensees on favorable terms. We cannot assure you that we will be able to enter into new collaboration arrangements on favorable terms, if at all, or that existing or future collaboration arrangements will succeed. WE DEPEND ON LICENSED PATENTS AND APPLICATIONS AND PROPRIETARY TECHNOLOGY. 24 Cygnus, Inc. September 30, 1999 Our success depends in large part on our ability to obtain patent protection for our products, preserve our trade secrets and operate without infringing the proprietary rights of others, both in the U.S. and abroad. Since patent applications in the U.S. are secret until issuance, and publication of discoveries in the scientific or patent literature tends to lag behind actual discovery by several months, we cannot be certain that we were the first to file our patent applications or that we will not infringe upon third party patents. We cannot assure you that any patents will be issued with respect to any of our patent applications or that any patents will provide competitive advantages for our products or will not be challenged or circumvented by our competitors. We also rely on trade secrets and proprietary know-how that we seek to protect, in part, by confidentiality agreements with our licensees, employees and consultants. We cannot assure you that these agreements will not be breached, that we would have adequate remedies for any breach or that our trade secrets will not otherwise become known or be independently developed by our competitors. Any litigation, in the U.S. or abroad, as well as foreign opposition and/or domestic interference proceedings, could result in substantial expense to us and significant diversion of effort by our technical and management personnel. We may resort to litigation to enforce our patents or protect trade secrets or know-how as well as to defend against infringement charges. A negative determination in such proceedings could subject us to significant liabilities or require us to seek licenses from third parties. Although patent and intellectual property disputes in the pharmaceutical product area have often been settled through licensing or similar arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties. Furthermore, we cannot assure you that necessary licenses would be available to us on satisfactory terms, if at all. Accordingly, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling certain of our products, and could materially adversely affect us. WE ARE HIGHLY LEVERAGED AND MAY BE UNABLE TO SERVICE OUR DEBT. As of September 30, 1999, we had indebtedness of $51.6 million, $23.0 million of which can be converted to Common Stock. The degree to which we are leveraged could materially and adversely affect our ability to obtain financing for working capital, acquisitions or other purposes and could make us more vulnerable to industry downturns and competitive pressures. Our ability to meet our debt service obligations depends upon our future performance, which will depend upon financial, business and other factors, many of which are beyond our control. Although we believe our cash flows will be adequate to meet our interest payments, we cannot assure you that we will continue to generate cash flows in the future sufficient to cover our fixed charges or to permit us to satisfy any redemption obligations pursuant to our indebtedness. If we cannot generate cash flows in the future sufficient to cover our fixed charges or to permit us to satisfy any redemption obligations pursuant to our indebtedness, and we cannot borrow sufficient funds either under our credit facilities or from other sources, we may need to refinance all or a portion of our existing debt, to sell all or a portion of our assets, or to sell equity securities. There is no assurance that we could successfully refinance, sell our assets or sell equity securities, or, if we could, we cannot give any assurance as to the amount of proceeds we could realize. In the event of insolvency, bankruptcy, liquidation, reorganization, dissolution or winding up of our business or upon default or acceleration related to our debt obligations, our assets will 25 Cygnus, Inc. September 30, 1999 first be available to pay the amounts due under our debt obligations. Holders of Common Stock would only receive the assets remaining, if any, after payment of all indebtedness and preferred stock. Although we do not currently conduct operations through subsidiaries, we may elect to do so as products become commercialized. In such event, our cash flow and our ability to service debt would partially depend upon the earnings of our subsidiaries and the distribution, loaning or other payments of funds by those subsidiaries to us. The payment of dividends and the making of loans and advances to us by our subsidiaries would be subject to statutory or contractual restrictions, would depend upon the earnings of those subsidiaries and would be subject to various business considerations. Our right to receive assets of any of our subsidiaries upon their liquidation or reorganization would be effectively subordinated to the claims of our subsidiaries' creditors, except to the extent that we are recognized as a creditor of such subsidiary, in which case our claims would still be subordinate to any security interests in the assets of such subsidiary and any senior indebtedness. WE HAVE LIMITED MARKETING AND SALES EXPERIENCE. We have limited experience marketing or selling medical device products. To successfully market and sell the GlucoWatch - Registered Trademark - monitor or our other products under development, we must either develop a more extensive marketing and sales force or enter into arrangements with third parties to market and sell our products. We cannot assure you that we could successfully develop a more extensive marketing and sales force or that we could enter into acceptable marketing and sales agreements with third parties. If we maintain our own marketing and sales capabilities, we will compete with other companies that have experienced and well-funded marketing and sales operations. If we enter into a marketing arrangement with a third party, any revenues we receive will depend on the third party, and we will likely have to pay a sales commission or similar fee. WE MAY BE SUBJECT TO PRODUCT LIABILITY CLAIMS. The design, development, manufacture and use of our products involve an inherent risk of product liability claims and associated adverse publicity. Producers of medical products may face substantial liability for damages in the event of product failure or allegations that the product caused harm. We currently maintain product liability insurance, but it is expensive and difficult to obtain and may not be available in the future on acceptable terms. We cannot assure you that we will not be subject to product liability claims, that our current insurance would cover any claims, or that adequate insurance will continue to be available on acceptable terms in the future. In the event we are held liable for damages in excess of the limits of our insurance coverage, or if any claim or product recall creates significant adverse publicity, our business, financial condition and results of operations could be materially and adversely affected. WE MAY NOT BE ABLE TO RETAIN OR HIRE KEY PERSONNEL. Our ability to operate successfully and manage our potential future growth significantly depends upon retaining key scientific, technical, managerial and financial personnel, and attracting and retaining additional highly qualified scientific, technical, managerial and financial personnel. We face intense competition for qualified personnel in these areas, and we cannot assure you that we will be able to attract and retain qualified personnel. The loss of key personnel 26 Cygnus, Inc. September 30, 1999 or our inability to hire and retain additional qualified personnel in the future could adversely affect our business, financial condition and operating results. OUR STOCK PRICE IS VOLATILE. The trading price of our Common Stock substantially fluctuates in response to factors such as: - - announcements by us or our competitors of results of regulatory approval filings or clinical trials or testing, - - developments or disputes governing proprietary rights, - - technological innovations or new commercial products, government regulatory action, and general conditions in the medical technology industry, - - changes in securities analysts' recommendations, or - - other events or factors, many of which are beyond our control. In addition, the stock market in general has experienced extreme price and volume fluctuations in recent years that have particularly affected the market prices of many medical technology companies, unrelated to the operating performance of these companies. Fluctuations or decreases in the trading price of our Common Stock may adversely affect the market for our Common Stock. In the past, following periods of volatility in the market price for a company's securities, securities class action litigation often has been instituted. Such litigation could result in substantial costs and a diversion of management attention and resources, which could have a material adverse effect on our business, financial condition and operating results. WE DO NOT PAY DIVIDENDS. We have never declared or paid cash dividends on our Common Stock. Our current bank term loan precludes us from paying dividends to stockholders. We currently intend to retain any earnings for use in our business and therefore do not anticipate paying any dividends in the future. 27 Cygnus, Inc. September 30, 1999 PART II. OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K a) EXHIBITS The following exhibits are filed herewith or incorporated by reference: 3.1 Bylaws of the Registrant, as amended, incorporated by reference to Exhibit 3.3 of the Registrant's Registration Statement Form S-1 No. 33-38363. 3.2 Restated Articles of Incorporation of the Registrant, as amended and filled with the Office of the Secretary of State of Delaware on May 21, 1999. 4.1 Specimen of Common Stock certificate of the Registrant, incorporated by reference to Exhibit 4.1 of the Registrant's Registration Statement Form S-1 No. 33-38363. 4.2 Rights Agreement dated September 21, 1993 between the Company and Chemical Trust Bank of California (the "Transfer Agent"), which includes the Certificate of Determination for the Series A Junior Participating Preferred Stock as Exhibit A, the Form of Right Certificate as Exhibit B and the Summary of Rights to purchase Preferred Shares as Exhibit C, incorporated by reference to Exhibit I of the Registrant's Form 8-A filed on October 21, 1993, Registration No. 0-18962. 4.3 Form of Senior Indenture incorporated herein by reference to Exhibit 4.1 filed with the Company's Registration Statement on Form S-3 (File No. 33-39275) declared effective by the Securities and Exchange Commission on November 12, 1997 (the "November 1997 Form S-3"). 4.4 Form of Subordinated Indenture incorporated herein by reference to Exhibit 4.2 filed with the Company's November 1997 Form S-3. 4.5 Form of Senior Debt Security (included in Exhibit 4.1) incorporated herein by reference to Exhibit 4.3 filed with the Company's November 1997 Form S-3. 4.6 Form of Subordinated Debt Security (included in Exhibit 4.2) incorporated herein by reference to Exhibit 4.4 filed with the Company's November 1997 Form S-3. 28 Cygnus, Inc. September 30, 1999 4.7 First Supplemental Indenture dated as of February 2, 1998 by and between Cygnus, Inc. and State Street Bank and Trust Company of California, N.A., incorporated by reference to Exhibit 4.5 of the Company's Form 8-K dated February 4, 1998. 4.8 Second Supplemental Indenture, dated as of October 28, 1998, by and between Cygnus, Inc. and State Street Bank and Trust Company of California, N.A., to the Indenture dated as of February 3, 1998 and the First Supplemental Indenture dated as of February 3, 1998, incorporated by reference to Exhibit 4.8 of the Company's Form 8-K filed on October 30, 1998. 4.9 First Amendment to the Rights Agreement dated October 26, 1998 between he Company and ChaseMellon Shareholder Services, L.L.C. (the "Rights Agent" successor to Chemical Trust), incorporated by reference to Exhibit 99.1 of the Registrant's Form 8-A/A filed on December 14, 1998, Registration No. 0-18962. 4.10 Amended and Restated Rights Agreement dated October 27, 1998 between the Company and ChaseMellon Shareholder Services, L.L.C. (the "Rights Agent" successor to Chemical Trust), which includes the Certificate of Determination for the Series A Junior Participating Preferred Stock as Exhibit A, the Form of Right Certificate as Exhibit B and the Summary of Rights to purchase Preferred Shares as Exhibit C, incorporated by reference to Exhibit 99.2 of the Registrant's Form 8A/A filed on December 14, 1998, Registration No. 0-19962. 4.11 Registration Rights Agreement dated June 30, 1999 between the Registrant and Cripple Creek Securities, LLC., incorporated by reference to Exhibit 4.11 of the Registrant's Form 10-Q for the quarter ended June 30, 1999. 4.12 Registration Rights Agreement dated June 29, 1999 between the Registrant and the listed investors on Schedule I thereto, incorporated by reference to Exhibit 4.12 of the Registrant's Form 10-Q for the quarter ended June 30, 1999. 10.39 Sublease Agreement dated February 19, 1999 between the Registrant and The 3DO Company, incorporated by reference to Exhibit 10.39 of the Registrant's Form 10-Q for the period ending March 31, 1999, filed April 27, 1999. 10.40 Structured Equity Line Flexible Financing Agreement, dated June 30, 1999 between the Registrant and Cripple Creek Securities, LLC, incorporated by referenced to Exhibit 1 of the Registrant's Form 8-K filed on July 2, 1999. 10.41 Convertible Debenture and Warrant Purchase Agreement dated June 29, 1999 between the Registrant and the listed investors on Schedule I thereto, incorporated by reference to Exhibit 10.41 of the Registrant's Form 10-Q for the quarter ended June 30, 1999. 10.42 Form of 8.5% Convertible Debenture Due June 29, 2004, incorporated by reference to Exhibit 10.42 of the Registrant's Form 10-Q for the quarter ended June 30, 1999. 29 Cygnus, Inc. September 30, 1999 10.43 Form of Common Stock Purchase Warrant, incorporated by reference to Exhibit 10.43 of the Registrant's Form 10-Q for the quarter ended June 30, 1999. 10.44 Amendment No. 4 Lease Extension to Lease Agreement dated as of October 15, 1991 between the Registrant and Lincoln Menlo Associates Limited, a California Limited Partnership, dated July 20, 1999. 10.45 1999 Stock Incentive Plan. 10.46 Amendment No. 1 to Structured Equity Line Flexible Financing Agreement, dated September 29, 1999 between the Registrant and Cripple Creek Securities, LLC, incorporated by reference to Exhibit 1.1 of the Registrant's Form 8-K filed on October 7, 1999. *10.47 Manufacturing and Supply Agreement and Amendment thereto; and Side Letter dated September 30, 1999 between the Registrant and LTS Lohmann Therapy Systems Corp. 10.48 Amended 1991 Employee Stock Purchase Plan (As Amended and Restated as of October 1, 1999), incorporated by reference to Exhibit 99.1 of the Company's Form S-8 Registration Statement No. 333-89377, filed October 20, 1999. 27 Financial Data Schedule *A confidential treatment request has been applied for or granted with respect to a portion of this document. 30 Cygnus, Inc. September 30, 1999 B) REPORTS ON FORM 8-K Cygnus filed one Report on Form 8-K for the quarter ended September 30, 1999. On October 7, 1999, Cygnus filed a Current Report on Form 8-K, reporting under Item 5: On September 22, 1999, Cygnus, Inc. issued a press release, the text of which is attached hereto as Exhibit 99.1, announcing that its 7-day estrogen transdermal hormone replacement therapy patch was cleared for marketing by the United States Food and Drug Administration (FDA). On September 28, 1999, Cygnus, Inc. issued a press release, the text of which is attached hereto as Exhibit 99.2, announcing that it had been awarded a Phase I Small Business Innovative Research (SBIR) grant for "High Performance Biosensor Electrode Materials" from the National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health (NIH). On September 29, 1999, Cygnus, Inc. issued 361,174 shares of its Common Stock for $4 million to Cripple Creek Securities, LLC ("Cripple Creek"), pursuant to its Structured Equity Line Flexible Financing Agreement with Cripple Creek, dated as of June 30, 1999, as amended by Amendment No. 1 to Structured Equity Line Flexible Financing Agreement dated as of September 29, 1999, attached hereto as Exhibit 1.1, the contents of which are incorporated herein by reference. The number of shares issued to Cripple Creek may be increased in accordance with the terms of such agreement. Also on September 29, 1999, Cygnus, Inc. received $3 million for the issuance of a $3 million aggregate principal amount of its Convertible Debentures and five-year Warrants to purchase approximately 135,624 shares of its Common Stock (subject to adjustment). 31 Cygnus, Inc. September 30, 1999 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. CYGNUS, INC. Date: JANUARY 20, 2000 By: /S/ JOHN C. HODGMAN ------------------------------- ------------------------------- John C. Hodgman Chairman, President and Chief Executive Officer (Principal Executive Officer) Date: JANUARY 20, 2000 By: /S/ CRAIG W. CARLSON ------------------------------- ------------------------------- Craig W. Carlson Senior Vice President, Finance and Chief Financial Officer (Principal Accounting Officer) 32 Cygnus, Inc. September 30, 1999 INDEX OF EXHIBITS The following exhibits are included herein: Exhibit *10.47 Manufacturing and Supply Agreement and Amendment thereto; and Side Letter dated September 30, 1999 between the Registrant and LTS Lohmann Therapy Systems Corp. *A confidential treatment request has been applied for or granted with respect to a portion of this document.