-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CN48YilzuvY+sOd/GBnZOwmUOVf/YAWmVGGUxRBI4Qgd052qLKerjst2SSXLelC5 yhHmT//DmpPeWD8tZqHKOg== 0000950129-98-000899.txt : 19980309 0000950129-98-000899.hdr.sgml : 19980309 ACCESSION NUMBER: 0000950129-98-000899 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 19971231 FILED AS OF DATE: 19980306 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: LIFECELL CORP CENTRAL INDEX KEY: 0000849448 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 760172936 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 000-19890 FILM NUMBER: 98558838 BUSINESS ADDRESS: STREET 1: 3606 RESEARCH FOREST DR STREET 2: LIFECELL CORPORATION CITY: WOODLANDS STATE: TX ZIP: 77381 BUSINESS PHONE: 7133675368 MAIL ADDRESS: STREET 1: 3606 RESEARCH FOREST DR CITY: THE WOODLANDS STATE: TX ZIP: 77381 10-K 1 LIFECELL CORPORATION - 12/31/97 1 - ------------------------------------------------------------------------------- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 1997 COMMISSION FILE NUMBER 0-19890 LIFECELL CORPORATION A DELAWARE IRS EMPLOYER IDENTIFICATION CORPORATION NO. 76-0172936 3606 RESEARCH FOREST DRIVE THE WOODLANDS, TEXAS 77381 Telephone Number (281) 367-5368 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: Common Stock, $.001 Par Value 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 __ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ] Aggregate market value of the voting stock (Common Stock and Series B Preferred Stock, assuming conversion of such Preferred Stock into Common Stock at the current conversion rate) held by non-affiliates of registrant as of March 2, 1998: $57,368,000 Number of shares of registrant's Common Stock outstanding as of March 2, 1998: 11,146,518. (If the Series B Preferred Stock had converted into Common Stock as of such date, there would be 15,059,388 shares of Common Stock outstanding.) DOCUMENTS INCORPORATED BY REFERENCE: Portions of registrant's proxy statement relating to the 1998 annual meeting of stockholders have been incorporated by reference into Part III hereof. - ------------------------------------------------------------------------------- 2 TABLE OF CONTENTS DESCRIPTION
Item Page - ------------------------------------------------------------------------------------------------------------------- PART I............................................................................................................3 Item 1. Business...........................................................................................3 General............................................................................................3 Technology.........................................................................................4 Strategy...........................................................................................5 Products and Product Development Activities........................................................6 Marketing.........................................................................................12 Sources of Materials..............................................................................12 Government Regulation.............................................................................13 Research and Development..........................................................................17 Patents, Proprietary Information and Trademarks...................................................18 Competition.......................................................................................19 Environmental Matters.............................................................................19 Employees.........................................................................................19 Special Note Regarding Forward-Looking Statements.................................................19 Risk Factors......................................................................................20 Item 2. Properties........................................................................................30 Item 3. Legal Proceedings.................................................................................30 Item 4. Submission of Matters to a Vote of Security Holders...............................................30 PART II..........................................................................................................31 Item 5. Market for the Registrant's Common Equity and Related Stockholder Matters.........................31 Dividend Policy...................................................................................31 Item 6. Selected Financial Data...........................................................................32 Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.............32 General and Background............................................................................33 Results of Operations.............................................................................33 Liquidity and Capital Resources...................................................................34 Item 7A. Quantitative and Qualitative Disclosure About Market Risk.........................................35 Item 8. Financial Statements and Supplementary Data.......................................................35 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure..............35 PART III.........................................................................................................35 Item 10. Directors and Executive Officers of the Registrant................................................35 Item 11. Executive Compensation............................................................................36 Item 12. Security Ownership of Certain Beneficial Owners and Management....................................36 Item 13. Certain Relationships and Related Transactions....................................................36 PART IV..........................................................................................................36 Item 14. Exhibits, Financial Statement Schedules, and Reports on Form 8-K..................................36
2 3 PART I This Annual Report on Form 10-K contains, in addition to historical information, "forward-looking statements" (within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) that involve risks and uncertainties. See "Business--Special Note Regarding Forward-Looking Statements." ITEM 1. BUSINESS GENERAL LifeCell Corporation ("LifeCell" or "the Company") is a bioengineering company engaged in the development and commercialization of tissue regeneration and cell preservation products. The Company's patented tissue processing and cell preservation technologies serve as platforms for a broad range of potential products addressing significant clinical needs in multiple markets. The Company's first commercial product is AlloDerm(R) acellular dermal graft ("AlloDerm"), a tissue graft consisting of an extracellular tissue matrix that retains the essential biochemical and structural composition of human dermis. The Company believes that AlloDerm is the only commercial tissue transplant product that promotes the regeneration of normal human soft tissue. AlloDerm currently is being marketed in the United States and internationally for use in certain reconstructive plastic, dental and burn surgery applications. The Company estimates that AlloDerm has been transplanted in over 20,000 patients. LifeCell also is developing several additional products, including injectable AlloDerm, vascular grafts, nerve connective tissue grafts, composite skin grafts, heart valves, and ThromboSolTM platelet storage solution ("ThromboSol"). LifeCell's strategy is to be a leader in the research, development, sales and marketing of tissue regeneration and cell preservation products. The primary elements of the Company's business strategy include (i) expanding penetration of AlloDerm into current target markets, (ii) expanding the use of AlloDerm into new applications and (iii) leveraging the Company's technology platforms to develop new products. The Company's product development programs have been generated from the following proprietary technologies: (i) a method for producing an extracellular tissue matrix by removing antigenic cellular elements while stabilizing the matrix against damage; (ii) a method for cell preservation that protects cells during prolonged storage; and (iii) a method for freeze-drying biological cells and tissues without the damaging effects of ice crystals. LifeCell's tissue processing technology removes cells that would be the target of rejection upon transplantation while preserving the essential biochemical and structural composition of the extracellular tissue matrix. This process is designed to create an acellular tissue that is not rejected by the body and functions as a natural template or scaffold into which a patient's own cells will migrate following transplantation. As a result, the tissue promotes normal soft tissue regeneration. The Company believes its tissue processing technology offers a number of other key benefits, including multiple product applications, safety, prolonged shelf-life and high compatibility with other technologies. AlloDerm is an extracellular matrix tissue graft processed from donated human skin. Following transplant, the AlloDerm graft becomes repopulated with the patient's own cells and is revascularized (i.e., blood supply is restored), becoming engrafted into the patient. As a result of its ability to promote the regeneration of normal human soft tissue, AlloDerm has multiple product applications. AlloDerm currently is used in certain reconstructive plastic, dental and burn surgery applications. The Company estimates, based on the most recently published industry data from various sources, that each year in the United States there are approximately 1.0 million reconstructive plastic surgery procedures, 480,000 dental soft tissue grafts, 230,000 dental bone-related grafts and more than 20,000 burn patients requiring skin grafts. LifeCell markets AlloDerm to hospital-based surgeons in domestic and selected international markets. In the United States, LifeCell utilizes its own direct sales force, supplemented with a network of regional specialty distributors. In addition, in June 1997, LifeCell entered into an agreement with Lifecore Biomedical, Inc. ("Lifecore") for the exclusive distribution of AlloDerm for dental applications in the United States. LifeCell also is developing an international network of distributors to market AlloDerm for multiple applications in markets outside the United States. The Company currently is evaluating the use of AlloDerm in additional applications and is developing new products based on its technology platforms. LifeCell is conducting research on the use of AlloDerm in urological 3 4 surgery, neurosurgery, orthopedic surgery and general surgery. In addition, LifeCell is developing an injectable form of AlloDerm for use in multiple potential applications, including urological, dermatological and reconstructive surgery. If successfully developed, an injectable form of AlloDerm would allow for delivery of the product through the use of a syringe, rather than a surgical incision, thereby creating additional market opportunities. LifeCell also is conducting research on the use of its technologies in other product opportunities, including vascular grafts, nerve connective tissue grafts, composite skin grafts, heart valves, venous valves, ThromboSol and a solution for the prolonged storage of transfusable red blood cells. TECHNOLOGY The Company's product development programs have been generated from the following proprietary technologies: (i) a method for producing an extracellular tissue matrix by removing antigenic cellular elements while stabilizing the matrix against damage; (ii) a method for cell preservation by manipulating cells through signal transduction (i.e., manipulation of cellular metabolism) to protect cells during prolonged storage; and (iii) a method for freeze-drying biological cells and tissues without the damaging effects of ice crystals. TISSUE PROCESSING TECHNOLOGY LifeCell's tissue processing technology removes antigenic cells from the tissue matrix to eliminate the potential for specific rejection of the transplanted tissue. The Company's tissue processing technology also (i) stabilizes the tissue matrix to preserve its natural structure and biochemical properties that promote cell repopulation and (ii) freeze-dries the tissue matrix without significant ice crystal damage to allow for extended storage and avoid a non-specific immune response upon transplantation. Soft tissue contains a complex, three-dimensional structure consisting of multiple forms of collagen, elastin, proteoglycans, other proteins, growth factors and vascular channels (the "tissue matrix"). Together, the tissue matrix and the cells that populate it form the soft tissues of the body, such as dermis, heart valves, blood vessels and other tissue types. As part of the body's natural remodeling process, certain cells actively break down and replace the tissue matrix on a continual basis. The tissue matrix itself, however, cannot be regenerated by the body in the event that a large portion of it is destroyed or lost as a result of trauma or surgery. The only method of replacing large sections of the tissue matrix is through transplantation. Soft tissue transplants from one part of the patient's body to another (autograft) generally are successful; however, the procedure results in the creation of an additional wound site. Historically, the ability to transplant tissue from one person to another (allograft) has been limited because the donor's cells within the transplanted tissue may trigger an immune response, resulting in rejection of the transplanted tissue. The Company believes that previous attempts to remove cells from soft tissue grafts before performing an allograft transplant have resulted in disruption or damage of the tissue matrix, causing an inflammatory response and rejection of the tissue following transplantation. LifeCell believes its tissue processing technology may offer some or all of the following important benefits, depending on the specific application: Natural Tissue Regeneration. Tissue grafts produced with LifeCell's tissue processing technology retain the structural and biochemical properties that stimulate natural cell repopulation and normal soft tissue regeneration. In addition, the Company's clinical studies with dermis and preliminary animal studies with heart valve leaflets and vascular grafts processed with the Company's technology indicate that such tissues can be remodeled by the recipient's own cells and may eventually become the recipient's own tissue. Multiple Potential Applications. The Company believes that its tissue processing technologies may have the potential to generate additional products with multiple applications. In addition to the current commercial applications of AlloDerm (i.e., reconstructive plastic, dental and burn surgery), the Company believes that AlloDerm may provide additional benefits in neurosurgery, urological surgery and orthopedic surgery. The Company also is evaluating the applicability of its technologies to other tissues, including heart valves, blood vessels and nerves. The Company currently is conducting animal studies with heart valves and vascular grafts processed with the Company's technology. LifeCell has conducted certain cross-species studies that indicate its tissue processing technology also may potentially allow for transplantation of animal tissues into humans. 4 5 Safety. The Company's tissue processing technology is designed to produce products that will revascularize and integrate into the body's own tissues. The patient's immune cells also are able to penetrate into the transplanted tissue and thus aid in preventing infections. In contrast, certain synthetic implants do not allow penetration of the patient's immune cells, thereby compromising the body's natural ability to fight infections. Prolonged Shelf-Life. The Company's proprietary tissue processing technology allows extended storage and ease of transportation of products. For example, AlloDerm can be stored at refrigerated temperatures for up to two years. In contrast, most traditional allograft tissues require special methods of storage and transportation. Compatibility with Other Technologies. Several types of tissues processed with the Company's technology retain important biochemical sites (proteoglycans) which bind growth factors and stem cells, which can stimulate tissue regeneration. As a result, the Company believes it may be possible to utilize its technology to develop tissue-based delivery vehicles for these factors and cells. CELL PRESERVATION TECHNOLOGY Blood cells circulating within the body are exposed to multiple factors which maintain their stability and prevent activation. When blood cells are removed from the body for storage, these stabilizing influences are absent, resulting in the destabilization and irreversible activation of the cells. These damaging events currently limit the shelf-life of transfusable red blood cells to 42 days under refrigeration and blood platelets to five days at room temperature. LifeCell's cell preservation technology mimics the stabilizing influences that are present in the body through manipulation of signal transduction mechanisms that control cellular metabolism, combined with either low temperature storage or the Company's patented freeze-drying technology. If successfully implemented, LifeCell's cell preservation technology could result in multiple products for the preservation of directly transfusable blood cells with extended shelf-life which could be stored in a manner consistent with current blood banking practices. STRATEGY LifeCell's objective is to be a leader in the research, development, sales and marketing of tissue regeneration and cell preservation products. The Company currently is focusing primarily on the broad commercialization of its first product, AlloDerm, which the Company estimates has been used to treat over 20,000 patients since its commercial introduction in 1994. The Company's strategy includes the following principal elements: EXPANDING PENETRATION OF ALLODERM INTO CURRENT TARGET MARKETS The Company intends to expand the penetration of its AlloDerm products into certain target markets. The Company currently markets AlloDerm for use in reconstructive plastic, dental and burn surgery in domestic and selected international markets through its own sales force and through distributors. The Company intends to increase the penetration of AlloDerm into these markets by (i) conducting additional clinical studies to demonstrate the benefits of AlloDerm compared to other current therapies, (ii) facilitating the publication by surgeons of additional papers in leading scientific journals describing the uses and benefits of AlloDerm, (iii) utilizing its expanded sales and marketing staff to call on a broader audience of hospital-based surgeons, (iv) establishing additional distribution relationships with leading suppliers of medical products, both for domestic and selected international markets and (v) utilizing direct mail and advertising campaigns, sponsoring educational and training workshops on the use of AlloDerm and participating in trade shows. EXPANDING THE USE OF ALLODERM INTO NEW APPLICATIONS LifeCell intends to leverage its relationships with leading surgeons and other physicians and its hospital-based sales force to identify and promote new applications of AlloDerm. LifeCell intends to focus initially on new markets that are synergistic with its current hospital surgeon-focused distribution strategy, including neurosurgery, urological surgery, orthopedic surgery and general surgery. The Company currently is planning or conducting research, developmental and clinical activities to evaluate the use of AlloDerm in these applications. The Company 5 6 also is targeting leading surgeons in each of these fields to conduct studies with AlloDerm and to publish scientific and clinical articles to generate awareness of the applications of the product. LEVERAGING TECHNOLOGY PLATFORMS TO DEVELOP NEW PRODUCTS The Company plans to leverage its tissue processing and cell preservation technology platforms to develop new products. The Company currently is developing an injectable form of AlloDerm that it believes may be useful in the treatment of urinary incontinence as well as in dermatological and reconstructive applications. In addition, the Company intends to apply its tissue processing technology in the development of products based on other tissues, including vascular grafts, venous valves, nerve connective tissues and heart valves. The Company also is utilizing its proprietary cell preservation technology to extend the shelf-life of transfusable platelets and red blood cells. LifeCell plans to establish collaborative out-licensing arrangements with appropriate partners to fund the development and commercialization of certain of these products. PRODUCTS AND PRODUCT DEVELOPMENT ACTIVITIES The following table sets forth information about AlloDerm and the Company's products under development.
CURRENT USES OF ALLODERM APPLICATIONS (1) STATUS (2) Reconstructive Plastic Surgery Soft tissue repair and replacement Commercial Dental Surgery Gingival grafts Commercial Burns Dermal grafts Commercial POTENTIAL NEW USES OF ALLODERM APPLICATIONS (1) STATUS (2) Neurosurgery Duraplasty Development Urological Surgery Bladder sling Development Bladder wall extension General Surgery Abdominal wall closure Development Prevention of surgical adhesions Orthopedic Surgery Capsular ligament reinforcement Development OTHER PRODUCTS UNDER DEVELOPMENT APPLICATIONS (1) STATUS (2) Injectable AlloDerm Urinary incontinence Preclinical Revision of acne scars Vascular Grafts Coronary or below-knee peripheral bypass Preclinical Nerve Connective Tissue Nerve regeneration Preclinical Composite Skin Grafts Treatment of third-degree burns and chronic Preclinical ulcers ThromboSol Platelet storage solution Clinical Feasibility Heart Valves Heart valve replacement Research Venous Valves Chronic venous insufficiency Research Venous stasis ulcers Red Blood Cell Preservation Extended storage of red blood cells Research
(1) LifeCell markets AlloDerm for the repair or replacement of damaged or inadequate integumental tissue. LifeCell may not promote AlloDerm for certain uses without approval of the United States Food and Drug Administration (the "FDA"). Products other than AlloDerm may require separate filings with and approvals of the FDA. See "--Government Regulation." 6 7 (2) "Research" denotes a project in which proof-of-concept has not yet been established. "Preclinical" denotes a project in which animal studies have been conducted, are being conducted or are planned. "Development" denotes a project in which proof-of-concept has been established through in vitro or early-stage animal studies or post-market clinical use and the Company is conducting or intends to conduct further animal studies and clinical studies. "Clinical feasibility" denotes an early-stage trial in humans is being conducted. "Commercial" indicates applications for which surgeons currently are using the product. However, commercial does not necessarily denote that all factors, such as long-term efficacy, have been determined. The products or products under development listed in the preceding table are in various stages of research, development or commercialization. There can be no assurance that the products under development will be successfully developed or manufactured. Certain of the products under development will require regulatory approval before commercialization. Additionally, the regulatory status of AlloDerm when promoted for certain uses is currently uncertain. There can be no assurance that any product or product under development will receive regulatory approval if required, meet price or performance objectives, be developed on a timely basis or prove to be as effective or as well received as competing products. See "--Government Regulation." ALLODERM PRODUCTS AlloDerm is an extracellular tissue matrix graft processed from donated human (cadaveric) skin. The Company believes that AlloDerm is the only transplant tissue product on the market today that promotes the regeneration of normal human soft tissue. Following transplant, the AlloDerm graft becomes repopulated with the patient's own cells and is revascularized (i.e., blood supply is restored), becoming engrafted into the patient. As a result of its ability to promote the regeneration of normal human soft tissue, AlloDerm has multiple surgical applications. AlloDerm currently is used in reconstructive plastic, dental and burn surgery. The Company believes AlloDerm may be used in additional applications and is conducting activities to extend the use of AlloDerm to urological surgery, neurosurgery, orthopedic surgery and general surgery. LifeCell obtains donated human skin from unaffiliated tissue banks in the United States. LifeCell requires that the tissue banks supplying the Company with tissue comply with the FDA's human tissue regulations. In addition, the Company requires supplying tissue banks to comply with procedural guidelines outlined by the American Association of Tissue Banks. Microbiological and other quality assurance testing is conducted by LifeCell before AlloDerm tissue products are released for shipment. See "--Government Regulation." LifeCell has established what it believes to be adequate sources of donated skin tissue at acceptable costs to satisfy the foreseeable demand for AlloDerm tissue products. However, there can be no assurance that the future availability of donated human skin will be sufficient to meet LifeCell's demand for such materials. AlloDerm is shipped at ambient temperature by overnight delivery services and has a two-year refrigerated shelf-life. See "--Sources of Materials." In November 1997, Integra (Artificial Skin) Corporation ("Integra") and the Massachusetts Institute of Technology ("MIT") filed a lawsuit in the United States District Court for the District of Massachusetts, alleging that the use of AlloDerm infringes two patents licensed by MIT to Integra ("the Integra Patents"). The lawsuit seeks injunctive relief, an accounting of revenues, treble and other monetary damages and attorneys' fees. LifeCell filed a response to the complaint denying the infringement claims and asserting certain affirmative defenses and counterclaims. The Company has received an opinion from its patent counsel to the effect that the current uses of AlloDerm do not infringe the Integra Patents. This opinion represents only the reasoned professional judgment of the Company's patent counsel and is not binding on any court or third party. Patent litigation involves complex legal and factual questions. As a result, the outcome of such litigation is inherently unpredictable, and there can be no assurance that the result of this proceeding will be favorable to the Company or that it will not have a material adverse effect on the Company's business, operating results or financial condition. See "Legal Proceedings." RECONSTRUCTIVE PLASTIC SURGERY. In November 1995, LifeCell began marketing AlloDerm to reconstructive plastic surgeons. Such surgeons currently use or potentially may use AlloDerm generally as a soft tissue implant to repair or replace tissue deficits, as an interpositional graft for tissue closure or repair, as a graft or implant for scar revision, as a protective sheath covering nerves and tendons and as a sling to support tissue following nerve or muscle damage. Also, the Company believes that AlloDerm has additional uses in reconstructive surgery related to oncological reconstructive procedures. 7 8 Based on industry sources, the Company estimates that there are approximately 1.0 million reconstructive plastic surgical procedures performed annually in the United States in which AlloDerm could be used. Competitive products include synthetic materials, bovine collagen injections and autologous tissue. The Company believes AlloDerm has advantages over synthetic material because AlloDerm fully integrates into the patient and because certain synthetic materials are susceptible to infection, mobility and occasional extrusion. The Company also believes AlloDerm has advantages over bovine collagen, which tends to be resorbed after two to 12 months, requiring reapplication. The use of autologous tissue requires additional surgery, creating a separate wound and trauma to the patient. DENTAL SURGERY. LifeCell began marketing AlloDerm to dental surgeons in September 1995. The Company has an agreement, effective June 1997, with Lifecore Biomedical, Inc. for the exclusive distribution in the United States of AlloDerm for use in dental applications. Dental surgeons use AlloDerm tissue in free-gingival grafting and as a subepithelial connective tissue graft, procedures used to increase the amount of attached gum tissue supporting the teeth. Until the development of AlloDerm, these procedures could only be performed with autologous tissue excised from the roof of the patient's mouth and then transplanted to the gum or, to a limited extent, with freeze-dried allograft skin. The Company believes that AlloDerm provides significant clinical benefits for this procedure by eliminating the need for an autograft and by avoiding scar formation often associated with freeze-dried allograft skin. In clinical case studies performed by periodontists, AlloDerm grafts functioned comparably to autografts, spared the patient the pain and discomfort associated with the excision of the autograft and reduced surgical time. AlloDerm tissue products also are used as barrier membranes in guided bone regeneration. In this function, the AlloDerm tissue serves as a barrier over allograft bone grafts or bone substitutes, which are used to restore a degenerated jaw bone and surrounding gingival tissue. AlloDerm tissue products also are used to repair soft tissue defects of the gum. According to the most recently published data from the American Dental Association, there were approximately 480,000 soft tissue grafts and 230,000 bone-related grafts performed in 1990 in the United States. Competitive procedures use autologous tissue as well as synthetic material. The Company believes that AlloDerm has advantages over autologous tissue because of the reduced trauma to the patient, and over certain non-resorbable synthetic materials because it integrates into the patient and does not require a separate procedure for removal. BURNS. During 1994, LifeCell began commercial sales of AlloDerm for use in the treatment of third-degree and deep second-degree burns requiring skin grafting. The Company estimates that approximately 75,000 people are hospitalized each year in the United States due to burns and that more than 20,000 of such patients are admitted with major burns requiring skin grafts. Skin is the body's largest organ and is the first line of defense against invasion of foreign substances. It contains two functional layers, the upper surface consisting primarily of cells (epidermis) and an underlying foundational layer consisting primarily of extracellular matrix proteins and collagen (dermis). The epidermis functions as a water barrier and maintains hydration. The dermis provides other important skin properties including tensile strength, durability and elasticity. Dermis, like many other tissues of the body, is not capable of regenerating itself. Currently, third-degree and deep second-degree burns are treated with split-thickness skin autografts (the epidermal layer and a portion of the dermis) taken from uninjured areas of the patient's body. The use of AlloDerm with ultra-thin split-thickness skin autografts (the epidermal layer and a much thinner portion of the dermis) has produced comparable results to normal autografts while reducing donor site trauma. OTHER POTENTIAL APPLICATIONS OF ALLODERM. During 1997, the use of AlloDerm as dura mater (the protective lining between the brain and skull) replacement was developed by an independent hospital through a clinical evaluation in approximately 100 neurosurgery patients. The Company currently is conducting animal studies for the use of AlloDerm to repair or replace damaged dura mater. Currently, surgeons primarily use autologous tissue, allograft dura mater or bovine pericardium as a replacement for damaged dura. The use of bovine products and allograft dura mater has declined because of concerns over disease transmission. The Company believes that AlloDerm may be preferred over allograft dura mater because certain neurological diseases, such as Creutzfeld Jacob Disease, have not been documented to occur in dermis, the source material for AlloDerm. The Company believes that AlloDerm also may be preferable to autologous tissue because of the elimination of donor site trauma. 8 9 The FDA currently regulates allograft dura mater as a medical device and the product is subject to premarket notification requirements. In December 1997, the FDA notified the Company that AlloDerm, when labeled and promoted for use in dura mater replacement procedures, will be classified as a medical device. The Company believes, however, that the use of AlloDerm as a dura mater replacement falls within the FDA classification of "human tissue" intended for transplantation. The Company intends to discuss this matter further with the FDA. There can be no assurance that the FDA would agree that AlloDerm should be regulated as human tissue (rather than as a medical device or biologic) when it is labeled and promoted for use as a dura mater replacement. If the FDA continues to assert that the product, when intended for use as dura mater replacement, is a device, the Company intends to seek FDA clearance or approval to market AlloDerm for this intended use. See "--Government Regulation." The Company believes that AlloDerm also may be used as a bladder or urethral sling to treat certain forms of urinary incontinence and as a surgical material to expand bladder walls. Currently, autologous tissue (fascia), allograft tissue and synthetic materials are used for bladder sling procedures and autologous tissue is used to expand bladder walls. If successfully developed, AlloDerm in such applications could offer several advantages because of the product's ability to promote normal soft tissue regeneration and to eliminate donor site trauma. See "--Government Regulation." The Company has been advised by a small number of surgeons that AlloDerm also has been used to reinforce the capsular ligament surrounding certain joints. Based on preliminary results of these procedures reported to the Company by these surgeons, the Company intends to explore the use of AlloDerm to repair several defects associated with joints. These procedures may include capsular ligament reinforcement, ligament repair, and articular and meniscal cartilage repair. See "--Government Regulation." FDA STATUS OF ALLODERM. The FDA has notified the Company that the use of AlloDerm for replacement or repair of damaged or inadequate integumental tissue is "human tissue" within the meaning of the human tissue for transplantation regulations. The FDA has recently asserted that AlloDerm should be regulated as a medical device when it is labeled and promoted as a dura mater replacement. However, it is unclear whether the FDA would agree that the following indications for which AlloDerm has been used by physicians (and for which the Company may want to promote AlloDerm in the future) is human tissue or whether the FDA would regulate AlloDerm under its medical device authorities for these indications: (i) graft for guided bone regeneration; (ii) oncological reconstruction; (iii) urological applications; (iv) certain orthopedic surgeries; and (v) general surgeries. There can be no assurance that the FDA will not require the submission of premarket approval applications supported by extensive clinical data for these products. See "--Government Regulation." INJECTABLE ALLODERM LifeCell is developing an injectable form of AlloDerm (AlloDerm reduced to the size necessary for needle injection) for use in multiple applications, including urological, dermatological and reconstructive applications. The Company has conducted preliminary animal studies to evaluate an injectable form of AlloDerm. Based on these studies, the Company intends to conduct broader animal and clinical studies to evaluate further this potential product. If successfully developed, an injectable form of AlloDerm would allow for delivery of the product through the use of a syringe, rather than a surgical incision, thereby creating additional market opportunities. The Company believes that one of the principal urological uses of injectable AlloDerm may be for the treatment of urethral sphincter deficiency, a common cause of urinary incontinence. A variety of treatments exist for urethral sphincter deficiency, including injecting bovine collagen to bulk the sphincter muscle. Based on an independent market research report, the Company estimates that there were approximately 118,000 injections of bovine collagen in 1996 to treat urinary incontinence for 33,000 individuals in the United States. Additionally, certain dermatological procedures, such as the revision of acne scars, wrinkle filling and lip augmentation, use bovine collagen injections. According to such research report, there were approximately 178,000 dermal implants in 1996 in the United States. One of the disadvantages of bovine collagen has been its limited persistence over time due to resorption, generally requiring additional injections after two to 12 months. The Company believes that AlloDerm may potentially persist longer than bovine collagen, possibly reducing the requirement for patients to have multiple injections. The regulatory status of injectable forms of AlloDerm in the United States is uncertain. Although the Company believes that this form of AlloDerm should be classified as human tissue intended for transplantation, 9 10 there can be no such assurance. Additionally, certain configurations of injectable AlloDerm, such as those packaged to facilitate use by the physician, as well as certain clinical applications may be regulated as a medical device. If the product is classified as a device by the FDA, extensive delays may be encountered before the time, if ever, that the product may be commercially distributed. See "--Government Regulation." COMPOSITE SKIN GRAFTS LifeCell is developing a method for constructing a composite, bi-layered tissue product containing an AlloDerm dermal layer and an epidermis consisting of primordial keratinocytes (epidermal cells) isolated from the patient. If successfully developed, a composite skin graft product would effectively eliminate the requirement of taking an autologous skin graft from burn patients and possibly may be useful in the treatment of chronic ulcers. Preliminary animal studies conducted by the Company indicate the ability of the composite skin product to achieve wound closure. See "--Government Regulation." XENODERM LifeCell has conducted development activities for XenoDermTM processed porcine dermis, which is processed in a manner similar to AlloDerm to remove the cells that are targets for rejection and to preserve the dermal matrix. LifeCell believes that, if successfully developed, XenoDerm tissue products would have the advantage of a potentially increased raw material supply and could facilitate regulatory approval in and distribution to certain international markets. See "--Sources of Materials" and "--Government Regulation." Preliminary animal studies conducted by LifeCell indicate that XenoDerm tissue does not cause a significant immune response when transplanted cross-species. Preliminary animal studies conducted by unaffiliated laboratories have shown that XenoDerm tissue is potentially as effective as AlloDerm tissue in treating full-thickness skin loss. Non-viable animal to human transplants are classified by the FDA as devices, requiring regulatory approval prior to commercialization. See "--Government Regulation." CARDIOVASCULAR TISSUE PRODUCTS LifeCell is conducting animal studies to evaluate small-diameter vascular graft products for potential use in cardiovascular and vascular surgery. If successfully developed, a vascular graft would potentially be used in coronary artery bypass procedures or used to restore peripheral blood circulation in patients with vascular insufficiency, such as below-knee bypass procedures. Approximately 200,000 coronary artery bypass procedures are performed annually in the United States, according to an independent market research report. LifeCell currently is using allograft blood vessels for this development project, but may extend the technology to xenografts. See "--Government Regulation." LifeCell also currently is conducting preliminary research to determine the feasibility of developing venous valve products for the treatment of chronic venous insufficiency and venous stasis ulcers. LifeCell expects such products to be allograft venous valves developed using its patented technology. If successfully developed, such grafts would restore the normal function of certain venous valves in the leg and provide a treatment for or reduce the development of venous stasis ulcers. According to industry sources, approximately seven million people in the United States suffer from chronic venous insufficiency and approximately 500,000 people in the United States are treated annually for venous stasis ulcers. See "--Government Regulation." In 1994, LifeCell and Medtronic, Inc. ("Medtronic") entered into a license and development agreement for the development and potential commercialization of xenograft heart valves processed with LifeCell's technology. If successfully developed, the porcine heart valve would be surgically implanted to replace human heart valves that have become defective through disease or aging and that may not otherwise be repaired. As part of the Company's agreement with Medtronic for the development of heart valves, LifeCell granted Medtronic certain rights of first refusal to evaluate technology and negotiate license and development agreements for vascular graft products utilizing LifeCell's technology. See "--Research and Development" Based on an independent market research report, the Company estimates that there are approximately 80,000 heart valve replacement procedures performed each year in the United States, of which 45,000 are mechanical heart valves, 30,000 are animal tissue valves and 5,000 are human donor valves. Animal tissue heart valves on the market today generally are subject to progressive calcification, which hardens the valve and prevents it from functioning properly, requiring replacement seven to 12 years after transplantation. Mechanical heart valves 10 11 are more durable, often lasting the lifetime of the patient, but lack the blood flow dynamics of tissue valves and require the patient to remain on anticoagulants for life to prevent strokes. Human donor valves are used in a limited number of the procedures because of limited availability of donated valves suitable for transplantation. Based on early-stage research, the Company believes that it may be possible to develop porcine heart valves based on the same technology that the Company uses to produce AlloDerm tissue products. The Company would process porcine heart valves to remove the cells that would be recognized by the body as foreign while substantially maintaining the structure and biochemistry of the valve matrix. By making the transplanted heart valves non-immunogenic, LifeCell believes that such a valve could become less susceptible to calcification than other tissue valves and could become part of the recipient's body. Preliminary animal studies conducted by LifeCell have shown that the LifeCell heart valve leaflets transplanted in the thoracic descending aorta became repopulated with the recipient's own cells and were not rejected by the recipient. Other animal studies conducted by LifeCell have shown that the valves do not undergo significant calcification. An extensive FDA approval process would be required for xenograft heart valves, which could significantly delay or prevent product entry into this market. See "--Government Regulation." The Company may be required to obtain a license under one or more patents prior to commercializing any heart valve or vascular product, if developed. There can be no assurance that such a license will be available, or if available, that a license will be granted on terms which are commercially acceptable to the Company. NERVE CONNECTIVE TISSUE LifeCell is conducting research for the development of nerve matrix grafts using the Company's proprietary technology. If successfully developed, such products would provide the template for nerve regeneration following trauma. The Company's research program seeks to determine whether nerve tissue processed with the Company's technology to preserve significant biochemical or other matrix-based characteristics will enhance or promote the regeneration of nerves. See "--Government Regulation." BLOOD CELL PRESERVATION LifeCell is developing ThromboSol platelet storage solution to extend the shelf-life of transfusable platelets and other methods to extend the shelf-life of red blood cells, white blood cells and stem cells. THROMBOSOL. LifeCell is developing ThromboSol, a proprietary biochemical formulation designed to protect transfusable platelets from damage during storage at low temperatures. The expected use of the product would be by blood banks to extend the shelf-life of transfusable platelets, thereby increasing the supply of available platelets, as well as to store autologous platelets in advance for individuals expecting to undergo surgery or chemotherapy. There were approximately 8.3 million platelet units transfused in the United States in 1992, according to an industry survey. Platelets are blood cells that initiate clotting. Untreated platelets are sensitive to storage at low temperatures and cannot be effectively refrigerated. Presently, platelets are stored at room temperature and, due to the risk of microbial contamination, have a limited shelf-life of five days. LifeCell has shown in laboratory tests that the addition of ThromboSol solution preserves the functional aspects of refrigerated platelets for up to nine days and frozen platelets for more than six months. LifeCell initiated preliminary toxicity studies for ThromboSol platelet storage solution in late 1994 and began preclinical animal studies in 1995. A pilot clinical study under a physician-sponsored Investigational New Drug ("IND") currently is being conducted. LifeCell intends to license this product to major pharmaceutical and other companies after conducting initial feasibility clinical studies. Other companies are developing products to inactivate bacterial or viral contaminants in donated platelets. The successful development of such products could affect the demand for products developed by LifeCell. See "--Government Regulation." RED BLOOD CELLS. LifeCell is conducting research to develop procedures to freeze and freeze-dry red blood cells. Such technology would be used by blood banks for long-term storage of donated units of red blood cells, extending the available blood supply, and for storage of autologous red blood cells for individuals expecting to require blood transfusions as part of planned surgery. 11 12 Approximately 13 million units of blood are donated each year in the United States. Red blood cells currently may be stored up to 42 days under refrigeration. Current procedures to freeze red blood cells require the use of cryoprotectant solutions that are toxic to the recipient and must be removed by washing the cells prior to transfusion. This removal procedure is labor-intensive and requires the immediate transfusion of the thawed blood. The Company believes that the successful development of non-toxic low temperature methods of storage could simplify the use of frozen blood and potentially allow widespread storage of autologous blood. Numerous companies are attempting to develop blood substitute products and others are developing technologies to inactivate bacterial or viral contaminants in donated blood. Successful development of these products could affect the demand for any products developed by LifeCell. Any product developed will require extensive regulatory approvals, including approval of an IND by the FDA to conduct clinical trials. See "--Government Regulation." CRYOPRESERVED ALLOGRAFT SKIN In April 1995, LifeCell began processing and distributing cryopreserved allograft skin for use as a temporary or transitional covering for severe burn wounds. For patients with extensive burns, allograft skin assists in stabilizing the patient and preparing the wound bed for a permanent graft. Revenues from the sale of cryopreserved allograft skin were approximately $132,000, $403,000 and $470,000 during 1995, 1996 and 1997, respectively. MARKETING The Company currently distributes AlloDerm in the United States for most surgical applications through the Company's network of direct technical sales representatives and regional specialty distributors. Dental applications of AlloDerm in the United States are marketed through LifeCell's exclusive United States distributor, Lifecore Biomedical, Inc.. The Company currently intends to develop and commercialize additional tissue products processed from cardiovascular, neurological and other tissues in conjunction with corporate partners. As of March 2, 1998, LifeCell had a sales and marketing staff of 30 persons, including 17 domestic sales personnel, four international sales and marketing personnel, and nine domestic marketing and other personnel. The Company's sales representatives are responsible for interacting with surgeons, primarily plastic surgeons and burn surgeons, and educating them regarding the use and anticipated benefit of AlloDerm tissue grafts. LifeCell also participates in national and international conferences and trade shows, participates in or funds certain educational symposia or fellowship programs and advertises in industry trade publications. The Company has 16 regional specialty distributors in the United States with approximately 65 sales representatives. The Company currently is seeking foreign regulatory approvals where necessary to import AlloDerm into significant foreign markets and is developing a network of country-based distributors. The Company currently has appointed distributors in Canada, the United Kingdom, Italy, Sweden, The Netherlands, Belgium and South Africa. The Company also has engaged distributors for Korea, Taiwan, Brazil, Greece, Israel, Spain, Switzerland and Turkey, but formal approvals to import products have not yet been received. The Company currently is seeking regulatory approval in France to import AlloDerm, but has not yet engaged a distributor. The Company expects to conduct clinical trials in Germany to seek approval to import AlloDerm. SOURCES OF MATERIALS LifeCell pays a procurement fee to and obtains allograft skin and other tissues from unaffiliated tissue banks in the United States. LifeCell is expanding its current procurement of skin and other tissues to include any of approximately 150 tissue banks, including approximately 36 skin banks. Procurement of certain human organs and tissue for transplantation is subject to the restrictions of the National Organ Transplant Act, which prohibits purchase and sale of human organs and related tissue for "valuable consideration." See "--Government Regulation." Pursuant to contractual arrangements, LifeCell reimburses tissue banks for recovering and shipping to LifeCell donated human skin suitable for processing into AlloDerm and allograft skin as a temporary wound 12 13 dressing. In obtaining such tissues, LifeCell competes with treatment centers that use donated skin for temporary wound dressings. The Company has established what it believes to be adequate sources of donor skin at acceptable costs to satisfy the foreseeable demand for AlloDerm tissue products during 1998. Although the Company has not experienced any material difficulty in procuring adequate supplies of donor skin, there can be no assurance that the future availability of donated human skin will be sufficient to meet LifeCell's demand for such materials. Any supply shortage of available tissues in the future would have a material adverse effect on LifeCell's business financial condition and results of operations. The Company currently does not have procurement arrangements for other tissues related to products under development, and does not intend to develop such arrangements until such time as the products approach commercialization. In November 1997, LifeCell received notification that it had been awarded accreditation by the American Association of Tissue Banks ("AATB"). The AATB is recognized for the development of industry standards and its program of inspection and accreditation. The AATB provides a standards-setting function similar to the FDA's quality system regulations for medical device companies, and has procedures for accreditation similar to the International Standards Organization ("ISO") standards. LifeCell began the accreditation process in 1995. The AATB decision was made after a detailed audit of LifeCell's operations and procedures. The accreditation must be renewed every three years and is for the processing, storage and distribution of material used in AlloDerm and allograft skin. GOVERNMENT REGULATION Government regulation, both domestic and foreign, is a significant factor in the manufacture and marketing of LifeCell's current and developing products. In the United States, the Company's currently marketed human skin allograft and AlloDerm products are subject to regulation by the United States Food and Drug Administration (the "FDA"). The United States Food, Drug and Cosmetics Act (the "FDC Act"), the Public Health Service Act (the "PHS Act") and other federal statutes and regulations govern or influence the testing, manufacture, labeling, storage, record keeping, approval, advertising and promotion of such products. Non-compliance with applicable requirements can result in fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to authorize the marketing of new products or to allow the Company to enter into supply contracts, and criminal prosecution. In July 1997, the FDA published a final rule that became effective in January 1998 regulating "human tissue." The rule clarifies and modifies an earlier interim rule and defines human tissue as any tissue derived from a human body which is (i) intended for administration to another human for the diagnosis, cure, mitigation, treatment or prevention of any condition or disease and (ii) recovered, processed, stored or distributed by methods not intended to change tissue function or characteristics. The FDA definition excludes, among other things, tissue that currently is regulated as a human drug, biological product or medical device and excludes kidney, liver, heart, lung, pancreas or any other vascularized human organ. Unlike certain drugs, biologicals and medical devices, human tissue is not subject to premarket notification or approval by the FDA. In September 1996, the Company received a letter from the FDA to the effect that AlloDerm intended for use for replacement or repair of damaged or inadequate integumental tissue is human tissue within the meaning of the interim final rule. This FDA position reversed the preliminary agency determination that AlloDerm should be regulated under the medical device authorities. The provisions of the interim rule relied upon by the FDA in the September 1996 letter were unchanged in the final rule. Consequently, AlloDerm is not subject to premarket notification or approval by the FDA and the Company may promote and sell AlloDerm for use in the treatment of wounds, such as third-degree burns, in periodontal surgical procedures, such as free-gingival grafting and guided tissue regeneration, and in reconstructive plastic surgery procedures, such as contracture release grafting and scar revision. The agency also informed the Company that this decision applies only to AlloDerm when it is intended for use in transplantation, and the regulatory status of the product when it is promoted for other uses, such as a void filler for soft tissue, for cosmetic augmentation or as a wound healing agent (the "Additional Indications"), would need to be determined by the FDA on a case-by-case basis. While the Company's marketing efforts had not previously focused on the Additional Indications, as a follow-up to its September 1996 letter, the FDA informed the Company that AlloDerm for Additional Indications 13 14 would have to be formally presented to the FDA to determine if, with these indications, AlloDerm would continue to fall within the scope of the interim rule for human tissue and thus not require premarket clearance as a medical device. The Company was asked to indicate what changes in advertisement and promotion it would make for AlloDerm. The Company responded to the FDA letter in October 1996, and informed the agency that the Company believes that the distinctions drawn regarding the definition of transplantation and human tissue and between integumental tissue and all other tissue in the September 1996 letter were fairly novel and ones for which the Company would require clarification from the FDA as it goes forward. The Company believes that AlloDerm, when used for cosmetic augmentation and as a void filler, may still qualify as human tissue. Similarly, the Company advised the FDA that since almost every replacement or repair of damaged or inadequate tissue involves a cosmetic aspect, the Company believes that many cosmetic uses of AlloDerm are within the purview of human tissue. Nevertheless, the Company informed the FDA that it intends to follow the agency's decision and, until this matter is clarified on a case-by-case basis, will not promote AlloDerm for the Additional Indications. During late 1997, the Company notified the FDA that it believes that AlloDerm, when promoted for use in dura mater replacement procedures, is human tissue within the scope of the FDA's interim and final regulations. The Company requested a meeting to further discuss this matter. In December 1997, the FDA notified the Company that it believes that AlloDerm, when promoted for such use, should be classified as a medical device. The Company disagrees with such initial decision and will request a meeting with the FDA to further discuss the appropriate classification. There can be no assurance that the FDA will alter its initial determination that the labeling and promotion of AlloDerm for use in dura mater replacement procedures should be regulated as a medical device. Additionally, it is unclear whether the FDA would regulate AlloDerm under its medical device authorities for these indications: (i) graft for guided bone regeneration; (ii) oncological reconstruction; (iii) urological applications; (iv) certain orthopedic surgeries; and (v) general surgeries. In addition, further discussion with the FDA is required to determine the level of regulation that may be applied with regard to the promotion and marketing of injectable AlloDerm. There can be no assurance that the FDA will not finally conclude that use of AlloDerm for the Additional Indications or other indications should be regulated as a medical device and require a 510(k) premarket notification or premarket approval application for AlloDerm for such indications. If the FDA were to conclude definitively that the Company is required to obtain agency clearance of a 510(k) notification or approval of a premarket approval application for AlloDerm for duraplasty, for the Additional Indications or for other uses, the FDA may require the Company to conduct laboratory testing and preclinical and clinical studies of AlloDerm to support a marketing application. Testing, preparation of necessary applications and processing of those applications by the FDA is expensive and any required laboratory testing or preclinical or clinical studies that the Company would be required to conduct could take several years to complete. There can be no assurance that any required testing could be completed successfully, or that if successfully completed, would provide sufficient data and information to enable the FDA to determine, on a timely basis, if at all, that when AlloDerm is used for duraplasty, for the Additional Indications or for other uses, it is substantially equivalent to a legally marketed predicate device or is safe and effective for such uses and to permit the product to be marketed for such uses. Failure of the Company to receive any required FDA clearance or approval of AlloDerm for such uses on a timely basis would preclude promotion of AlloDerm for such uses and could have a material adverse effect on the Company's business, financial condition and results of operations. In October 1997, the FDA inspected LifeCell's facilities. No Form 483 Notice of Observations was left with the Company, although the agency did take copies of numerous documents relating to the AlloDerm production process and promotional material relating to AlloDerm. Notwithstanding the fact that no Form 483 was received, there can be no assurance that the FDA will not raise regulatory issues with respect to the documents taken for review. In February 1997, the FDA issued a comprehensive "proposed approach" to the regulation of cellular and tissue-based products, other than human tissue for transplantation. The FDA proposal sets forth a tiered approach to cell and tissue regulation that ranges from no regulatory requirements for cells or tissue that are removed and transplanted into the same patient in a single surgical procedure to full premarket approval requirements for biologics and medical devices that raise potential health, safety or efficacy concerns. Although the FDA has notified the Company that AlloDerm is not now subject to premarket notification or approval, there can be no assurance that the FDA will not impose additional or different regulatory requirements on AlloDerm after the agency finalizes its approach to the regulation of cellular and tissue-based products. 14 15 The FDA's final human tissue regulation requires establishments engaged in the procurement, processing, and distribution of human tissue to conduct and maintain records of tissue donor screening procedures and blood testing. In addition, tissue processing establishments are periodically inspected by the FDA to ensure compliance with these requirements. LifeCell believes that the Company's operations substantially comply with the requirements of the FDA's final human tissue regulation. LifeCell requires that the tissue banks supplying the Company with tissue comply with the FDA's human tissue regulation. In addition, the Company requires supplying tissue banks to comply with procedural guidelines outlined by the American Association of Tissue Banks. The FDA has stated that it will propose additional requirements for human tissue. Additional requirements could include registration of tissue banking establishments and tissue listing with the FDA. Other requirements may include donor-recipient tracking, Good Tissue Practices and clinical evaluation of tissues that are determined to have undergone other than "minimal manipulation." If significant additional regulatory requirements were to be established, the Company could incur significant additional costs in order to comply with such requirements. The regulatory status in the United States of injectable forms of AlloDerm is uncertain. Although the Company believes that this form of AlloDerm should be classified as human tissue intended for transplantation, there can be no such assurance. Additionally, certain configurations of injectable AlloDerm, such as those packaged to facilitate use by the physician, as well as certain clinical applications may be regulated as a medical device. If the product is classified as a device by the FDA, extensive delays may be encountered before the time, if ever, that the product may be commercially distributed. LifeCell believes that its allograft tissue products in development, including vascular grafts and nerve connective tissue, should be classified as "human tissue" under the FDA's regulations. However, further discussion with the FDA is required to determine the level of regulation the FDA will adopt with regard to the promotion and marketing of these products. There can be no assurance that the FDA will not require the submission of premarket approval application supported by extensive clinical data for these products. LifeCell's proposed xenograft heart valve product and other xenograft tissue transplantation products, including XenoDerm tissue and xenograft vascular grafts, likely will be subject to regulation by the FDA as medical devices. LifeCell's proposed blood cell preservation products, including ThromboSol platelet storage solution, will be subject to regulation as biologics. Accordingly, such products will require FDA premarket approval or clearance prior to commercialization. To obtain FDA approval or clearance for these products, the Company must submit proof of the safety and efficacy of these products. In most cases, this entails extensive pre-clinical and clinical testing performed in accordance with the FDA's regulations. The testing, preparation of necessary applications and processing of those applications by the FDA is expensive and time consuming and will take several years to complete. There is no assurance that the FDA will act favorably or quickly in making such reviews, and significant difficulties or costs may be encountered by the Company in its efforts to obtain the FDA approvals or clearances that could delay or preclude the Company from marketing any product it may develop. The FDA also may require post-market testing and surveillance to monitor the effects of approved products and may place conditions on approvals that could restrict commercial applications of such products. Product marketing approvals or clearances may be withdrawn if compliance with regulatory standards is not maintained or if problems occur following initial marketing. In addition, delays imposed by the governmental approval process may materially reduce the period during which the Company may have the exclusive right to commercialize patented products. The FDA reviews medical devices for marketing approval or clearance through two different procedures, the 510(k) premarket notification process and the premarket approval process, which is significantly more complex, costly and time consuming than the 510(k) clearance procedure. LifeCell will need to pursue one of these routes with respect to each product determined to be a medical device. The determination of which process will be required for any particular product will depend in part upon how the FDA has regulated similar products by the time LifeCell is ready to pursue its own approvals or clearances. Under the 510(k) premarket notification procedure, the applicant or "sponsor" submits an application containing data that demonstrates the "substantial equivalence" of the product to a device marketed prior to the enactment of the Medical Device Amendments of 1976 or to a device legally marketed thereafter pursuant to a 510(k). The FDA may require a 510(k) applicant to submit additional, and possibly extensive, clinical data establishing the safety and effectiveness of the product for each proposed indication. Prior to conducting the necessary clinical trials, an applicant may be required to submit an investigational device exemption ("IDE") protocol to the FDA for approval. An IDE application typically contains data from laboratory and animal testing demonstrating that the product is sufficiently safe for study in humans as well as a description of 15 16 the proposed study methods and protocol. Clinical studies must be conducted according to a written protocol and pursuant to the approval and oversight of one or more Institutional Review Boards. In addition, clinical investigators must adhere to good clinical practices. The FDA may order the temporary or permanent discontinuation of a clinical trial at any time for non-compliance with its regulations, because of safety issues or for other reasons. The collection of data and preparation of a 510(k) application can be costly and time consuming, and a 510(k) applicant may not market the product until a favorable decision is received from the FDA. The FDA review of a 510(k) premarket notification can take anywhere from a few months to several years. There can be no assurance that marketing clearance ultimately will be obtained for any of LifeCell's products that are the subject of 510(k) premarket notifications. The Pre-Market Approval ("PMA") process is significantly more complex, costly and time consuming than the 510(k) clearance procedure. To obtain premarket approval, the applicant is required to submit extensive preclinical and clinical data to the FDA. An IDE will be required to conduct the clinical trials. Upon completion and analysis of clinical studies, the applicant assembles and submits a PMA application setting forth the preclinical, clinical, manufacturing and other data. Typically, the FDA will also inspect the manufacturing facility for compliance with the Quality System regulation. FDA review and approval of a PMA can take several years. There can be no assurance that PMA approvals will be obtained for any of LifeCell's proposed products. With respect to LifeCell's proposed biological blood cell preservation products, the Company or its contracted designee must obtain both a product license and an establishment license from the FDA prior to marketing. A product license application ("PLA") and establishment license application ("ELA") must be submitted and supported by extensive data, including preclinical and clinical data that demonstrate that the manufactured product meets prescribed standards of safety and efficacy. Before conducting the required clinical testing of a biological product, an applicant must submit an investigational new drug application ("IND") to the FDA, containing preclinical data demonstrating the safety of the product for human investigational use, information about the manufacturing processes and procedures and the proposed clinical protocol. Clinical trials of biological products typically are conducted in three sequential phases, but may overlap. Phase I trials test the product in a small number of healthy subjects, primarily to determine its safety and tolerance at one or more doses. In Phase II, in addition to safety, the efficacy, optimal dose and side effects of the product are evaluated in a patient population somewhat larger than the Phase I trial. Phase III involves further safety and efficacy testing on an expanded patient population at geographically dispersed test sites. All clinical studies must be conducted in accordance with FDA approved protocol and are subject to the approval and monitoring of one or more Institutional Review Boards. In addition, clinical investigators must adhere to good clinical practices. Completion of all three phases of clinical studies may take several years, and the FDA may temporarily or permanently suspend a clinical study at any time. Upon completion and analysis of clinical trials, the applicant assembles and submits a PLA and an ELA. The ELA contains a complete description of the manufacturing process. Before the licenses can be granted, the Company or its designee must undergo a successful establishment inspection. FDA review and approval of a biological product can take several years. There can be no assurance that LifeCell will obtain the required approvals for any of its proposed biological products. All products marketed by LifeCell pursuant to the above-described approvals and clearances will be subject to pervasive and continuing regulation by the FDA. Products must be manufactured in registered establishments and must be produced in accordance with Quality System regulations (QSR), the successor to the FDA's GMP regulations. There are post-marketing surveillance and reporting requirements. Manufacturing facilities and processes are subject to periodic FDA inspection. Labeling and promotional activities are also subject to FDA scrutiny and, in certain instances, by the Federal Trade Commission. The export of devices and biologics is also subject to regulation and may require prior FDA clearance. From time to time, the FDA may modify such regulations and impose additional or different requirements. It is impossible to predict how such revisions would affect the Company's operations. Failure to comply with any applicable FDA requirements could result in civil and criminal enforcement actions and penalties. Sales of medical devices and biological products outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to commercialization of the product in those countries. Certain countries regulate AlloDerm as a pharmaceutical product, requiring extensive filings and regulatory approvals to market the product. Certain countries classify AlloDerm as "human tissue" but may restrict its import or sale. Other countries have no applicable regulations regarding the import or sale of products similar to AlloDerm, creating uncertainty 16 17 regarding the import or sale of the product. The inability to classify AlloDerm as a medical device has restricted LifeCell's ability to obtain an appropriate regulatory designation for the product for Western Europe, which would provide a clearer marketing path in the European Union. The time required to obtain foreign approvals may be longer or shorter than that required for FDA approval and there can be no assurance that approvals would be obtained for any of the Company's products. AlloDerm currently is being marketed in certain foreign countries, and LifeCell is actively pursuing clearance to market AlloDerm in additional countries. There can be no assurance that the uncertainty of regulations in each country will not delay or impede the marketing of AlloDerm or impede the ability of LifeCell to negotiate distribution arrangements on favorable terms. In addition, the National Organ Transplant Act ("NOTA") prohibits the acquisition, receipt or transfer of certain human organs, including skin and heart valves and vascular grafts for "valuable consideration," but permits the payment of reasonable expenses associated with the removal, transportation, processing, preservation, quality control and storage of human tissue and skin. Assuming that NOTA applies to LifeCell's products, it may be interpreted to limit the prices that LifeCell may charge for processing and transporting such human tissue products. LifeCell includes in its AlloDerm pricing structure certain of its educational costs associated with the processing and transportation of human tissue. Although LifeCell believes that recovery of educational costs is permitted under NOTA, a future inability of LifeCell to pass these costs on to purchasers of its products could adversely affect LifeCell's business and prospects. Assuming that NOTA applies to LifeCell's products, LifeCell intends to comply with NOTA, but there can be no assurance that the government will not adopt interpretations of NOTA that would adversely affect LifeCell's pricing structure or otherwise call into question one or more aspects of LifeCell's method of operation. Certain foreign countries have laws similar to NOTA. These laws may restrict the amount that the Company can charge for AlloDerm, and may restrict the importation or distribution of AlloDerm to licensed not-for-profit organizations. LifeCell also is subject to various federal, state and local laws, regulations and recommendations relating to such matters as safe working conditions, laboratory and manufacturing practices, and the use, handling and disposal of hazardous or potentially hazardous substances used and produced in connection with LifeCell's research and development work. See "--Environmental Matters." Although LifeCell believes it is in compliance in all material respects with these laws and regulations, there can be no assurance that the Company will not incur significant additional costs to comply with these laws or regulations in the future. RESEARCH AND DEVELOPMENT LifeCell has historically funded the development of its tissue products and blood cell preservation products primarily through external sources, including a corporate alliance and government grants and contracts, as well as through the proceeds from equity offerings. See "Management's Discussion and Analysis of Financial Condition and Results of Operations--Liquidity and Capital Resources." LifeCell's research and development costs in 1995, 1996 and 1997 for all programs, including those programs funded through corporate and government support, were approximately $2.2 million, $1.6 million, $2.0 million, respectively. The Company has received a substantial portion of its government grant funding pursuant to the United States government's Small Business Innovation Research ("SBIR") program. The SBIR grant program provides funding to evaluate the scientific and technical merit and feasibility of an idea. To date, LifeCell has been awarded approximately $4.6 million through 14 approved SBIR program awards and Department of Defense contracts. LifeCell intends to continue to seek funding through the SBIR programs, as well as to pursue additional government grant and contract programs. Generally, LifeCell has the right to patent any technologies developed from government grants and contract funding, subject to the United States government's right to receive a royalty-free license for federal government use and to require licensing to others in certain circumstances. In 1994, LifeCell entered into a license and development agreement with Medtronic to develop jointly the Company's heart valve products. Pursuant to the agreement, Medtronic paid LifeCell an initial $1.5 million license fee. Medtronic funds in part the cost of research and development under a mutually agreed upon budget, has the exclusive right to market any resulting commercial products and must pay LifeCell royalties on sales of products covered by the agreement. LifeCell's research and development funding by Medtronic in 1995, 1996 and 1997 was approximately $825,000, $546,000, $218,000, respectively. Royalties payable to LifeCell under the agreement are limited to an aggregate maximum of $25.0 million. Medtronic may terminate the agreement at any time if in its sole business judgment it deems the development and commercialization of products thereunder not to be in its best interests or otherwise to be imprudent. In such event, and if the agreement is terminated under certain other 17 18 circumstances, the $1.5 million initial license fee paid by Medtronic will be converted into shares of Common Stock, subject to certain limitations, at the market price at the time of conversion, and any unrecovered portion of the fee will be refunded to Medtronic. In 1994, Medtronic also invested $500,000 in LifeCell by purchasing approximately 64,000 shares of Common Stock in exchange for rights of first refusal to negotiate licenses for LifeCell's vascular graft products. Medtronic's rights of first refusal expire during 1998. PATENTS, PROPRIETARY INFORMATION AND TRADEMARKS LifeCell's ability to compete effectively with other companies is materially dependent upon the proprietary nature of its technologies. LifeCell relies primarily on patents, trade secrets and confidentiality agreements to protect its technologies. LifeCell currently licenses the exclusive right to nine United States patents and related foreign patents and the non-exclusive right to one United States patent. In addition, LifeCell has been issued three United States utility patents, one United States design patent and has six pending United States patent applications. The Company's technology is protected by three primary families of patents and patent applications. One United States patent covers methods of producing the Company's tissue-based products. Two United States patents and two pending patent applications cover methods of extending the shelf-life of platelets, red blood cells and other blood cells. Eight additional United States patents supplement the Company's other patents and cover methods of freeze-drying without the damaging effects of ice crystal formation. LifeCell also has applied for patent protection in several foreign countries. Because of the differences in patent laws and laws concerning proprietary rights, the extent of protection provided by United States patents or proprietary rights owned by or licensed to LifeCell may differ from that of their foreign counterparts. In November 1997, Integra and MIT filed a lawsuit in the United States District Court for the District of Massachusetts, alleging that the Company infringes one or more claims of the Integra Patents. The lawsuit seeks injunctive relief, an accounting of revenues, treble and other monetary damages and attorneys' fees. LifeCell filed a response to the complaint denying the infringement claims and asserting certain affirmative defenses and counterclaims. The Company has received an opinion from its patent counsel to the effect that the current uses of AlloDerm do not infringe the Integra Patents. This opinion represents only the reasoned professional judgment of the Company's patent counsel and is not binding on any court or third party. Patent litigation involves complex legal and factual questions. As a result, the outcome of such litigation is inherently unpredictable, and there can be no assurance that the result of this proceeding will be favorable to the Company or that it will not have a material adverse effect on the Company's business, operating results or financial condition. See "Legal Proceedings." In general, the patent position of biotechnology and medical product firms is highly uncertain and involves complex legal, scientific and factual questions. There can be no assurance that any other patents will be granted with respect to the patent applications filed by the Company. Furthermore, there can be no assurance that any patents issued or licensed to the Company will provide commercial benefit to the Company or will not be infringed, invalidated or circumvented by others. The United States Patent and Trademark Office currently has a significant backlog of patent applications, and the approval or rejection of patents may take several years. Prior to actual issuance, the contents of United States patent applications are generally not made public. Once issued, such a patent would constitute prior art from its filing date, which might predate the date of a patent application on which the Company relies. Conceivably, the issuance of such a patent, or the discovery of "prior art" of which the Company is currently unaware, could invalidate a patent of the Company or its licensor or prevent commercialization of a product disclosed therein. No assurances may be given that the Company's products or planned products may not be the subject of additional infringement actions by third parties. Any successful patent infringement claim relating to any products or planned products could have a material adverse effect on the Company. Further, there can be no assurance that any patents or proprietary rights owned by or licensed to LifeCell will not be challenged, invalidated, circumvented, or rendered unenforceable based on, among other things, subsequently discovered prior art, lack of entitlement to the priority of an earlier, related application or failure to comply with the written description, best mode, enablement or other applicable requirements. The Company generally does not conduct an extensive review of issued patents prior to engaging in research or development activities. Accordingly, the Company may be required to obtain a license from others to 18 19 commercialize any of its products under development. There can be no assurance that any such license that may be required could be obtained on favorable terms or at all. LifeCell may decide for business reasons to retain certain knowledge that it considers proprietary as confidential and elect to protect such information as a trade secret, as business confidential information, or as know-how. In that event, LifeCell must rely upon trade secrets, know-how and continuing technological innovation to maintain its competitive position. There can be no assurance that others will not independently develop substantially equivalent proprietary information or otherwise gain access to or disclose such information. LifeCell has federal trademark or service mark registrations that it currently uses for LifeCell(R), which concerns processing and preserving tissue samples, and AlloDerm(R), which concerns LifeCell's commercial acellular dermal graft product. COMPETITION The biomedical field is undergoing rapid and significant technological change. LifeCell's success depends upon its ability to develop and commercialize its technology. There are many companies and academic institutions that are capable of developing products based on similar technology, and that have developed and are capable of developing products based on other technologies, which are or may be competitive with LifeCell's products. Many of those companies and academic institutions are well-established, have substantially greater financial and other resources, research and development capabilities and more experience in conducting clinical trials, obtaining regulatory approvals, manufacturing and marketing than LifeCell. These companies and academic institutions may succeed in developing competing products that are more effective than LifeCell's products or that receive government approvals more quickly than LifeCell's products, which may render the Company's products or technology uncompetitive, uneconomical or obsolete. For most current applications of AlloDerm, the principal form of competition is with the use of the patient's autologous tissue. LifeCell anticipates direct competition for AlloDerm tissue products and all of its proposed transplantable tissue products, as well as indirect competition from advances in therapeutic agents, such as growth factors now used to enhance wound healing. LifeCell believes that therapeutic growth factors may be used in conjunction with its proposed products and may potentially enhance the products' efficacy. LifeCell is not aware of any person or entity currently marketing transplantable tissue products with features similar to AlloDerm or LifeCell's other proposed transplantable products. There can be no assurance, however, that LifeCell will be able to compete effectively with other commercially available products or that development of other technologies will not detrimentally affect LifeCell's commercial opportunities or competitive advantage. ENVIRONMENTAL MATTERS LifeCell's research and development and processing techniques generate waste that is classified as hazardous by the United States Environmental Protection Agency and the Texas Natural Resources Commission. LifeCell segregates such waste and disposes of it through a licensed hazardous waste transporter. Although LifeCell believes it is currently in compliance in all material respects with applicable environmental regulations, its failure to comply fully with any such regulations could result in the imposition of penalties, fines or sanctions that could have an adverse effect on LifeCell's business. EMPLOYEES At March 2, 1998, the Company had 99 full-time and two part-time employees of which 30 were employed in sales and marketing, 34 in engineering, production and quality assurance, 19 in research and development and clinical studies, and 18 in administration and accounting. As of March 2, 1998, the Company employed, full-time, two persons with M.D. degrees and eight persons with Ph.D. degrees. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended. All statements other than statements of historical facts included herein, including, without limitation, statements regarding the Company's financial position, business strategy, products, products under development, markets, budgets and plans and objectives of management for future operations, are forward-looking statements. Although 19 20 the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Important factors that could cause actual results to differ materially from the Company's expectations ("Cautionary Statements") are disclosed under "Risk Factors" and elsewhere herein, including, without limitation, in conjunction with the forward-looking statements included herein. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the Cautionary Statements. RISK FACTORS In addition to the other information in this Annual Report on Form 10-K, the following factors should be considered carefully in evaluating the Company. Special Note: Certain statements set forth below constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. See "--Special Note Regarding Forward-Looking Statements." HISTORY OF OPERATING LOSSES; SUBSTANTIAL ACCUMULATED EARNINGS DEFICIT Since its inception in 1986, the Company has generated only limited revenues from product sales and has incurred substantial losses, including losses of approximately $3.9 million, $4.1 million and $6.1 million for the years ended December 31, 1995, 1996, and 1997, respectively. At December 31, 1997, the Company had an accumulated deficit of approximately $36.4 million. The Company expects to incur additional operating losses as well as negative cash flow from operations at least through 1998 as it continues to use substantial resources to expand its marketing efforts with respect to AlloDerm and to expand its product development programs. There can be no assurance that the Company will ever become profitable. The Company's ability to increase revenues and achieve profitability and positive cash flows from operations will depend on increased market acceptance and sales of AlloDerm and commercialization of products under development. There can be no assurance that the Company will be successful in expanding AlloDerm sales or that the Company's development efforts will result in commercially available products, that the Company will obtain required regulatory clearances or approvals for any new products in a timely manner, or at all, that the Company will be successful in introducing any new products or that any new products will achieve a significant level of market acceptance. The development and commercialization of new products will require additional development, sales and marketing, manufacturing and other expenditures. The required level and timing of such expenditures will affect the Company's ability to achieve profitability and positive cash flows from operations. There can be no assurance that the Company will ever achieve higher levels of revenues or a profitable level of operations or that profitability, if achieved, can be sustained on an ongoing basis. See "--Risk Factors--No Assurance of Additional Necessary Capital," "--Risk Factors--Uncertainty of Market Acceptance" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." NO ASSURANCE OF ADDITIONAL NECESSARY CAPITAL The Company intends to expend substantial funds for product research and development, expansion of sales and marketing activities, expansion of manufacturing capacity, product education efforts, and other working capital and general corporate purposes. Although the Company believes that through its existing resources and anticipated cash flows from operations will be sufficient to satisfy its capital needs through at least 1999, there can be no assurance that the Company will not require additional financing before that time. The Company's actual liquidity and capital requirements will depend upon numerous factors, including the costs and progress of the Company's research and development efforts; the number and types of product development programs undertaken; the costs and timing of expansion of sales and marketing activities; the costs and timing of expansion of manufacturing capacity; the amount of revenues from sales of the Company's existing and new products; changes in, termination of, and the success of existing and new distribution arrangements; the cost of maintaining, enforcing and defending patents and other intellectual property rights, including the cost of defending the lawsuit relating to the Integra Patents; competing technological and market developments; developments related to regulatory and third-party reimbursement matters; and other factors. In the event that additional financing is needed, the Company may seek to raise additional funds through public or private financing, collaborative relationships or other arrangements. Any additional equity financing may be dilutive to stockholders, and debt financing, if available, may involve significant restrictive covenants. Collaborative arrangements, if necessary to raise additional funds, may require the Company to relinquish its rights to certain of its technologies, products or marketing territories. Failure to raise capital when needed could have a material adverse effect on the Company's business, financial 20 21 condition and results of operations. There can be no assurance that such financing, if required, will be available on terms satisfactory to the Company, if at all. If adequate funds are not available, the Company expects it will be required to delay, scale back or eliminate one or more of its product development programs. See "--Risk Factors--Patent Infringement Lawsuit," "Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Legal Proceedings." GOVERNMENT REGULATION--ALLODERM In July 1997, the United States Food and Drug Administration (the "FDA") published a final rule that became effective in January 1998 regulating "human tissue." The rule clarifies and modifies an earlier interim rule and defines human tissue as any tissue derived from a human body which is (i) intended for administration to another human for the diagnosis, cure, mitigation, treatment or prevention of any condition or disease and (ii) recovered, processed, stored or distributed by methods not intended to change tissue function or characteristics. The FDA definition excludes, among other things, tissue that currently is regulated as a human drug, biological product or medical device and excludes kidney, liver, heart, lung, pancreas or any other vascularized human organ. Unlike certain drugs, biologicals and medical devices, human tissue is not subject to premarket notification or approval by the FDA. In September 1996, the Company received a letter from the FDA to the effect that AlloDerm intended for use for replacement or repair of damaged or inadequate integumental tissue is human tissue within the meaning of the interim final rule. This FDA position reversed the preliminary agency determination that AlloDerm should be regulated under the medical device authorities. The provisions of the interim rule relied upon by the FDA in the September 1996 letter were unchanged in the final rule. Consequently, AlloDerm is not subject to premarket notification or approval by the FDA and the Company may promote and sell AlloDerm for use in the treatment of wounds, such as third-degree burns, in periodontal surgical procedures, such as free-gingival grafting and guided tissue regeneration, and in reconstructive plastic surgery procedures, such as contracture release grafting and scar revision. The agency also informed the Company that this decision applies only to AlloDerm when it is intended for use in transplantation, and the regulatory status of the product when it is promoted for other uses, such as a void filler for soft tissue, for cosmetic augmentation or as a wound healing agent (the "Additional Indications"), would need to be determined by the FDA on a case-by-case basis. While the Company's marketing efforts had not previously focused on the Additional Indications, as a follow-up to its September 1996 letter, the FDA informed the Company that AlloDerm for Additional Indications would have to be formally presented to the FDA to determine if, with these indications, AlloDerm would continue to fall within the scope of the interim rule for human tissue and thus not require premarket clearance as a medical device. The Company was asked to indicate what changes in advertisement and promotion it would make for AlloDerm. The Company responded to the FDA letter in October 1996, and informed the agency that the Company believes that the distinctions drawn regarding the definition of transplantation and human tissue and between integumental tissue and all other tissue in the September 1996 letter were fairly novel and ones for which the Company would require clarification from the FDA as it goes forward. The Company believes that AlloDerm, when used for cosmetic augmentation and as a void filler, may still qualify as human tissue. Similarly, the Company advised the FDA that since almost every replacement or repair of damaged or inadequate tissue involves a cosmetic aspect, the Company believes that many cosmetic uses of AlloDerm are within the purview of human tissue. Nevertheless, the Company informed the FDA that it intends to follow the agency's decision and, until this matter is clarified on a case-by-case basis, will not promote AlloDerm for the Additional Indications. During late 1997, the Company notified the FDA that it believes that AlloDerm, when promoted for use in dura mater replacement procedures, is human tissue within the scope of the FDA's interim and final regulations. The Company requested a meeting to discuss this matter further. In December 1997, the FDA notified the Company that it believes that AlloDerm, when promoted for such use, should be classified as a medical device. The Company disagrees with such initial decision and will request a meeting with the FDA to further discuss the appropriate classification. Additionally, it is unclear whether the FDA would regulate AlloDerm under its medical device authorities for these indications: (i) graft for guided bone regeneration; (ii) oncological reconstruction; (iii) urological applications; (iv) certain orthopedic surgeries; and (v) general surgeries. In addition, further discussion with the FDA is required to determine the level of regulation that may be applied with regard to the promotion and marketing of injectable AlloDerm. 21 22 There can be no assurance that the FDA will alter its initial determination that AlloDerm, when labeled and promoted for use as a dura mater replacement, should be regulated as a medical device. Additionally, there can be no assurance that the FDA will not finally conclude that use of AlloDerm for the Additional Indications or other indications should be regulated as a medical device and require a 510(k) premarket notification or premarket approval application for AlloDerm for such indications. If the FDA were to conclude definitively that the Company is required to obtain agency clearance of a 510(k) notification or approval of a premarket approval application for AlloDerm for duraplasty, for the Additional Indications or for other uses, the FDA may require the Company to conduct laboratory testing and preclinical and clinical studies of AlloDerm to support a marketing application. Testing, preparation of necessary applications and processing of those applications by the FDA is expensive and any required laboratory testing or preclinical or clinical studies that the Company would be required to conduct could take several years to complete. There can be no assurance that any required testing could be completed successfully, or that if successfully completed, would provide sufficient data and information to enable the FDA to determine, on a timely basis, if at all, that when AlloDerm is used for duraplasty, for the Additional Indications or for other uses, it is substantially equivalent to a legally marketed predicate device or is safe and effective for such uses and to permit the product to be marketed for such uses. Failure of the Company to receive any required FDA clearance or approval of AlloDerm for such uses on a timely basis would preclude promotion of AlloDerm for such uses and could have a material adverse effect on the Company's business, financial condition and results of operations. In October 1997, the FDA inspected LifeCell's facilities. No Form 483 Notice of Observations was left with the Company, although the agency did take copies of numerous documents relating to the AlloDerm production process and promotional material relating to AlloDerm. Notwithstanding the fact that no Form 483 was received, there can be no assurance that the FDA will not raise regulatory issues with respect to the documents taken for review. In February 1997, the FDA issued a comprehensive "proposed approach" to the regulation of cellular and tissue-based products, other than human tissue for transplantation. The FDA proposal sets forth a tiered approach to cell and tissue regulation that ranges from no regulatory requirements for cells or tissue that are removed and transplanted into the same patient in a single surgical procedure to full premarket approval requirements for biologics and medical devices that raise potential health, safety or efficacy concerns. Although the FDA has notified the Company that AlloDerm is not now subject to premarket notification or approval, there can be no assurance that the FDA will not impose additional or different regulatory requirements on AlloDerm after the agency finalizes its approach to the regulation of cellular and tissue-based products. Human tissue is regulated by the FDA in a manner the agency has deemed necessary to protect the public health from the transmission of various infectious diseases, including human immunodeficiency virus ("HIV") infection, syphilis and hepatitis infection, through transplantation of tissue from donors with or at risk of these diseases. Under the FDA regulations, all facilities engaged in the procurement, processing, storage or distribution of human tissue intended for transplant are required to assure that certain infectious disease testing and donor screening is performed and that records documenting such testing for each tissue are available for inspection by the FDA. The regulations also provide authority for the FDA to conduct inspections of human tissue facilities and to detain, recall or destroy tissue for which appropriate documentation is not available. Although the Company believes that it conducts its operations in compliance in all material respects with such requirements, no assurances may be given in such regard. Non-compliance with applicable requirements can result in fines, injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal of the government to authorize the marketing of new products or to allow the Company to enter into supply contracts and criminal prosecution. The National Organ Transplant Act ("NOTA") prohibits the acquisition, receipt or transfer of certain human organs, including skin, for "valuable consideration." NOTA permits the payment of reasonable expenses associated with the removal, transportation, processing, preservation, quality control and storage of human tissue and skin. NOTA may be interpreted to limit the prices that LifeCell may charge for processing and transporting its human tissue products. This could result in limited revenues which could adversely affect LifeCell's business, financial condition and results of operations. See "--Government Regulation." PATENT INFRINGEMENT LAWSUIT In November 1997, Integra and MIT filed a lawsuit in the United States District Court for the District of Massachusetts, alleging that the Company infringes one or more claims of the Integra Patents. The lawsuit seeks injunctive relief, an accounting of revenues, treble and other monetary damages and attorneys' fees. LifeCell filed a 22 23 response to the complaint denying the infringement claims and asserting certain affirmative defenses and counterclaims. The Company has received an opinion from its patent counsel to the effect that the current uses of AlloDerm do not infringe the Integra Patents. This opinion represents only the reasoned professional judgment of the Company's patent counsel and is not binding on any court or third party. Patent litigation involves complex legal and factual questions. As a result, the outcome of such litigation is inherently unpredictable, and there can be no assurance that the result of this proceeding will be favorable to the Company or that it will not have a material adverse effect on the Company's business, operating results or financial condition. If it is determined that the Company is infringing the Integra Patents, the court could issue an injunction prohibiting the Company from making, using or selling its AlloDerm product for some or all of its intended uses. Such injunction could also extend to the Company's other potential products under development. In addition, the court could assess significant damages and attorneys' fees against the Company, which would have a material adverse effect on the Company's business, operating results and financial condition and otherwise affect the ability of the Company to continue as a viable enterprise. In addition, an adverse determination in this proceeding could require the Company to seek licenses from Integra, which may not be available on reasonable terms, if at all. Regardless of the outcome, defending such claims could involve significant costs and diversion of management resources, which could have a material adverse effect on the Company's business, operating results or financial condition. See "--Risk Factors--Dependence on Patents and Proprietary Rights" and "Legal Proceedings." GOVERNMENT REGULATION--PROPOSED PRODUCTS Many if not all of LifeCell's products under development will require regulatory approval or clearance prior to commercialization. Human therapeutic products are subject to rigorous preclinical and clinical testing as a condition of approval by the FDA and by similar regulatory authorities in foreign countries. The lengthy process of obtaining these approvals and clearances and the ongoing process of compliance with applicable federal statutes and regulations will require the expenditure of substantial resources, and there can be no assurance that FDA or foreign approvals will be obtained for any of the Company's proposed products. The regulatory status of injectable forms of AlloDerm in the United States is uncertain. Although the Company believes that this form of AlloDerm should be classified as human tissue intended for transplantation, there can be no such assurance. Additionally, certain configurations of injectable AlloDerm, such as those designed to facilitate use by the physician, may be regulated as a medical device. If the product is classified as a device by the FDA, extensive delays may be encountered before the time, if ever, that the product may be commercially distributed. See "--Government Regulation." LifeCell believes that its allograft tissue products in development, including vascular grafts and nerve connective tissue, should be classified as "human tissue" under the FDA's regulations. However, further discussion with the FDA is required to determine the level of regulation the FDA will adopt with regard to the promotion and marketing of these products. There can be no assurance that the FDA will not require the submission of premarket approval application supported by extensive clinical data for these products. See "--Risk Factors--Government Regulation--Proposed Products." LifeCell's proposed xenograft heart valve and other xenograft tissue transplantation products will be subject to regulation as medical devices. The Company's proposed blood cell preservation products will be subject to regulation as biologics. Such products require FDA premarket clearance or approval prior to commercialization in the United States. To obtain FDA approval for these products, the Company must submit proof of their safety and efficacy. Testing, preparation of necessary applications and processing of those applications by the FDA is expensive and time consuming. There can be no assurance that the FDA will act favorably or quickly in making such reviews, and significant difficulties or costs may be encountered by the Company in its efforts to obtain FDA clearances that could delay or preclude the Company from marketing any product it may develop. The FDA may also place conditions on clearances that could restrict commercial applications of such products. Product marketing approvals or clearances may be withdrawn if compliance with regulatory standards is not maintained or if problems occur following initial marketing. Delays imposed by the governmental clearance process may materially reduce the period during which the Company has the exclusive right to commercialize patented products. Products marketed by LifeCell pursuant to FDA or foreign approval will be subject to pervasive and continuing regulation. In the United States, devices and biologics must be manufactured in registered establishments and must be produced in accordance with the FDA's "Quality System" regulation for medical devices or "Good Manufacturing Practices" ("GMP") regulations for biologics. Manufacturing facilities and 23 24 processes are subject to periodic FDA inspection. Labeling and promotional activities are also subject to scrutiny by the FDA and, in certain instances, by the Federal Trade Commission. The export of devices and biologics is also subject to regulation and may require FDA approval. From time to time, the FDA may modify such requirements, imposing additional or different requirements. Failure to comply with any applicable FDA requirements could result in civil and criminal enforcement actions and other penalties. In addition, there can be no assurance that the various states in which LifeCell's products are sold will not impose additional regulatory requirements or marketing impediments. The National Organ Transplant Act prohibits the acquisition, receipt or transfer of certain human organs, including heart valves and vascular grafts, for "valuable consideration," which could affect the commercialization of certain of the Company's proposed human tissue products. See "--Risk Factors--Government Regulation--AlloDerm" and "--Government Regulation." FOREIGN REGULATORY STATUS OF ALLODERM The regulation of AlloDerm outside the United States varies by country. Certain countries regulate AlloDerm as a pharmaceutical product, requiring extensive filings and regulatory approvals to market the product. Certain countries classify AlloDerm as a transplant tissue but may restrict its import or sale. Other countries have no applicable regulations regarding the import or sale of products similar to AlloDerm, creating uncertainty regarding the import or sale of the product. There can be no assurance that the various foreign countries in which LifeCell's products are sold will not impose additional regulatory requirements. AlloDerm currently is being marketed in certain foreign countries, and LifeCell is pursuing clearance to market AlloDerm in additional countries. There can be no assurance that the uncertainty of regulations in each country will not delay or impede the marketing of AlloDerm or impede the ability of LifeCell to negotiate distribution arrangements on favorable terms. Certain foreign countries have laws similar to the United States' National Organ Transplant Act. These laws may restrict the amount that the Company can charge for AlloDerm and may restrict the importation or distribution of AlloDerm to licensed not-for-profit organizations. See "--Government Regulation." UNCERTAINTY OF MARKET ACCEPTANCE Much of the Company's ability to increase revenues and to achieve profitability and positive cash flow will depend on expanding the use and market penetration of its AlloDerm product and the successful introduction of its products in development. Products based on the Company's technologies represent new methods of treatment. Physicians will not use the Company's products unless they determine that the clinical benefits to the patient are greater than those available from competing products or therapies. Even if the advantage of the Company's products is established as clinically significant, physicians may not elect to use such products for any number of reasons. As such, there can be no assurance that any of the Company's AlloDerm products or products under development will gain any significant degree of market acceptance among physicians, health care payors and patients. Broad market acceptance of the Company's products may require the training of numerous physicians and clinicians, as well as conducting or sponsoring clinical studies to demonstrate the benefits of such products. The amount of time required to complete such training and studies could result in a delay or dampening of such market acceptance. Moreover, health care payors' approval of reimbursement for the Company's products in development will be an important factor in establishing market acceptance. See "--Risk Factors--Limited Third-Party Reimbursement." DELAYED OR UNSUCCESSFUL PRODUCT DEVELOPMENT The Company's growth and profitability will depend, in part, upon its ability to complete development of and successfully introduce new products. The Company may be required to undertake time-consuming and costly development activities and seek regulatory clearance or approval for new products. Although the Company has conducted animal studies on many of its products under development which indicate that the product may be feasible for a particular application, there can be no assurance that the results obtained from expanded studies will be consistent with earlier trial results or be sufficient for the Company to obtain any required regulatory approvals or clearances. There can be no assurance that the Company will not experience difficulties that could delay or prevent the successful development, introduction and marketing of new products, that regulatory clearance or approval of these or any new products will be granted on a timely basis, if ever, or that the new products will adequately meet 24 25 the requirements of the applicable market or achieve market acceptance. The completion of the development of any of the Company's products under development remains subject to all the risks associated with the commercialization of new products based on innovative technologies, including unanticipated technical or other problems, manufacturing difficulties and the possible insufficiency of the funds allocated for the completion of such development, which could result in a change in the design, delay in the development or the abandonment of such products. Consequently, there can be no assurance that any of the Company's products under development will be successfully developed or manufactured or, if developed and manufactured, that such products will meet price or performance objectives, be developed on a timely basis or prove to be as effective as competing products. The inability to complete successfully the development of a product or application, or a determination by the Company, for financial, technical or other reasons, not to complete development of any product or application, particularly in instances in which the Company has made significant capital expenditures, could have a material adverse effect on the Company's business, financial condition and results of operations. DEPENDENCE ON KEY MANAGEMENT AND PERSONNEL The success of LifeCell will be dependent largely on the efforts of Paul M. Frison, Chairman of the Board, President and Chief Executive Officer of the Company, and Stephen A. Livesey, M.D., Ph.D., Executive Vice President, Chief Science Officer and a director of the Company. The loss of either person's services would have a material adverse effect on LifeCell's business, financial condition and results of operations. LifeCell has obtained "keyman" life insurance on Mr. Frison and Dr. Livesey of $1.0 million and $3.0 million, respectively. Dr. Livesey, a citizen of Australia, has applied for permanent residence status in the United States. There can be no assurance that he will be able to obtain such status. The Company does not have employment agreements with any of its employees. Further, the success of LifeCell is also dependent upon its ability to hire and retain qualified operating, marketing and technical personnel. The competition for qualified personnel in the biomedical industry is intense and, accordingly, there can be no assurance that LifeCell will be able to hire or retain such personnel. DEPENDENCE ON CORPORATE COLLABORATORS The Company expects to rely in the future on corporate collaborative partners for the development and commercialization of certain products and to conduct certain clinical trials, obtain regulatory approvals and manufacture and market any resulting products. Although the Company believes that any such collaborative partners would have an economic motivation to commercialize any products that might result from such arrangements, the amount and timing of resources devoted to these activities by such parties could depend on the achievement of technical and research goals by the Company and generally would be controlled by such partners. Moreover, collaborative arrangements generally provide that they may be terminated by the collaborator prior to their expiration under circumstances that also may be outside the control of the Company. Any eventual sale of products may depend further on the successful completion of arrangements with other partners, licensees or distributors in each territory. There can be no assurance that the Company will be successful in establishing any such collaborative arrangements on acceptable terms, if at all, or that any such future collaborator would be successful in commercializing any resulting products. In 1994, LifeCell entered into a license and development agreement with Medtronic, Inc. ("Medtronic") to develop jointly the Company's heart valve products. Pursuant to the agreement, Medtronic paid LifeCell an initial $1.5 million license fee, funds costs of research and development under a mutually agreed upon budget, including clinical trials, if any, and will pay royalties of up to an aggregate of $25.0 million on sales of products covered by the agreement. There can be no assurance that Medtronic will perform its obligations under the agreement, will not reduce committed funding for the Company's heart valve development program, will not terminate the agreement, that Medtronic or LifeCell will successfully develop or market any products under the agreement or that LifeCell will ever receive royalties under the agreement. Furthermore, there can be no assurance that Medtronic or future collaborators will not pursue existing or alternative technologies in preference to potential products being developed in collaboration with the Company. DEPENDENCE ON DISTRIBUTOR SALES Sales to distributors constitute a significant portion of the Company's revenues. The Company has only recently entered into certain of its current distribution arrangements. The Company may be required to enter into additional distribution arrangements to achieve broad distribution of AlloDerm or any future products. There can be no assurance that the Company will be able to maintain its current distributor arrangements or, in the event of termination of any of these arrangements, that a new distributor will be found, or that the Company will be able to enter into and maintain arrangements with additional distributors on acceptable terms, or on a timely basis, if ever. 25 26 The Company's distributors generally purchase and maintain inventories of AlloDerm in anticipation of future sales to surgeons and hospitals. The termination of the distributor's relationship with the Company may have an adverse effect on LifeCell's sales until such inventories are sold. There can be no assurance that these distributors will devote the resources necessary to provide effective sales and marketing support to the Company or market the Company's products at prices that can achieve market acceptance. In addition, the Company's distributors may give higher priority to the products of other medical suppliers or their own products, thus reducing their efforts to sell the Company's products. If any of the Company's distributors becomes unwilling or unable to promote, market and sell the Company's products, the Company's business, financial condition and results of operations could be materially adversely affected. The Company has engaged Lifecore Biomedical, Inc. as the exclusive distributor for AlloDerm for dental applications in the United States, and other distributors also may be granted exclusive distribution rights. To the extent any exclusive distributor fails adequately to promote, market and sell the Company's products, the Company may not be able to secure a replacement distributor until after the term of the distribution contract is complete or until such contract can otherwise be terminated. See "--Marketing." DEPENDENCE ON CERTAIN SOURCES OF MATERIALS The Company's business will be dependent on the availability of donated human skin, cardiovascular tissue and other tissues. A finite supply of donated tissue is available. Although the Company has established what it believes to be adequate sources of donated human skin to satisfy the expected demand for AlloDerm during 1998, LifeCell has not yet developed a supply of other tissues and there can be no assurance that the availability of donated human skin and other tissues will be sufficient to meet LifeCell's demand for such materials. Any significant interruption in supply of such tissue would likely have a material adverse effect on the Company's business, financial condition and results of operations. See "--Sources of Materials." The Company acquires donated human skin from various non-profit organizations which procure skin and other donated human tissue. The procurement of skin generally constitutes a small portion of the operating funds for such non-profit organizations. The development of products that replace the need for donated tissue, such as the development of synthetic bone substitutes to replace allograft bone procured by the organizations, could threaten the existence of the non-profit organizations and, therefore, adversely affect the supply of donated human skin to LifeCell or increase the required payments from LifeCell. The Company has performed limited activities to develop products using porcine dermis and other animal tissues as a substitute for donated human skin. If successfully developed, animal tissue could replace the need for human tissue as a raw material. There can be no assurance that such animal tissue products can be successfully developed, that such development and required regulatory approvals could result in timely replacement of human tissue used by LifeCell in the event of a reduced supply of human tissue or that the cost of such animal tissue would not materially adversely affect the business, financial condition and results of operations of the Company. Donors of organs and tissues, including donated human skin, have various motivations. Although LifeCell does not promote the use of AlloDerm for cosmetic applications, AlloDerm has been used by surgeons in a variety of applications that may be considered "cosmetic." Knowledge of such use by potential donors could impact their willingness to donate skin for such uses. See "--Risk Factors--Product Liability and Insurance" and "--Risk Factors--Sources of Materials." TECHNOLOGICAL CHANGE AND COMPETITION The biomedical field is undergoing rapid and significant technological change. LifeCell's success depends upon its ability to develop and commercialize efficient and effective products based on its technology. There are many companies and academic institutions that are capable of developing products based on similar technology, and that have developed and are capable of developing products based on other technologies, which are or may be competitive with LifeCell's products. Many of these companies and academic institutions are well-established, have substantially greater financial and other resources, research and development capabilities and more experience in conducting clinical trials, obtaining regulatory approvals, manufacturing and marketing than LifeCell. These companies and academic institutions may succeed in developing competing products that are more effective than LifeCell's products, or that receive government approvals more quickly than LifeCell's products, which may render the Company's products or technology uncompetitive, uneconomical or obsolete. See "--Competition." 26 27 LIMITED THIRD-PARTY REIMBURSEMENT Generally, hospitals, physicians and other health care providers purchase products, such as the products being sold or developed by LifeCell, for use in providing care to their patients. These parties typically rely on third-party payors, including Medicare, Medicaid, private health insurance and managed care plans, to reimburse all or part of the costs of acquiring those products and costs associated with the medical procedures performed with those products. Cost control measures adopted by third-party payors in recent years have had and may continue to have a significant effect on the purchasing practices of many health care providers, generally causing them to be more selective in the purchase of medical products. Significant uncertainty exists as to the reimbursement status of newly approved health care products. The Company believes that certain third-party payors provide reimbursement for medical procedures at a specified rate without additional reimbursement for products, such as those being sold or developed by LifeCell, used in such procedures. There can be no assurance that adequate third-party payor reimbursement will be available for the Company to maintain price levels sufficient for realization of an appropriate return on its investment in developing new products. In addition, government and other third-party payors continue to refuse, in some cases, to provide any coverage for uses of approved products for indications for which the FDA has not granted marketing approval. Many uses of AlloDerm have not been granted such marketing approval and there can be no assurance that any such uses will be approved. Further, certain of the Company's products are used in medical procedures that typically are not covered by third-party payors, such as "cosmetic" procedures, or for which patients sometimes do not obtain coverage, such as dental procedures. These and future changes in third-party payor reimbursement practices regarding the procedures performed with LifeCell's products could adversely affect the market acceptance of LifeCell's products. See "--Government Regulation." DEPENDENCE ON PATENTS AND PROPRIETARY RIGHTS LifeCell's ability to compete effectively with other companies is materially dependent upon the proprietary nature of its technologies. LifeCell relies primarily on patents and trade secrets to protect its technologies. LifeCell currently licenses the exclusive right to nine United States patents and related foreign patents and non-exclusive rights to one patent. In addition, LifeCell has been issued three United States utility patents, one United States design patent and has five pending United States patent applications. There can be no assurance that LifeCell will obtain any additional patents or other protection, that the patents currently applied for will be granted, that, if the patents currently applied for are granted, the claims allowed will be sufficient to protect LifeCell's technology, or that existing patents or proprietary rights owned by or licensed to LifeCell will provide significant commercial benefits. Further, there can be no assurance that any patents or proprietary rights owned by or licensed to LifeCell will not be challenged, invalidated, circumvented, or rendered unenforceable based on, among other things, subsequently discovered prior art, lack of entitlement to the priority of an earlier, related application or failure to comply with the written description, best mode, enablement or other applicable requirements. The invalidation, circumvention or unenforceability of key patents or proprietary rights owned by or licensed to LifeCell could have a material adverse effect on LifeCell and on its business, financial condition and results of operations. LifeCell's success will depend in part on its ability to maintain and obtain patent protection for its technology both in the United States and other countries. Other companies and research and academic institutions may have developed technologies, filed patent applications or received patents on various technologies that may be related to LifeCell's business. Some of these patent applications, patents or technologies may conflict with LifeCell's patent applications, patents or technologies. Any such conflict could invalidate or limit the scope of LifeCell's patents or could result in denial of LifeCell's patent applications. In general, the patent position of biotechnology and medical product firms is highly uncertain and involves complex legal, scientific and factual questions. There can be no assurance that any other patents will be granted with respect to the patent applications filed by the Company. Furthermore, there can be no assurance that any patents issued or licensed to the Company will provide commercial benefit to the Company or will not be infringed, invalidated or circumvented by others. The United States Patent and Trademark Office currently has a significant backlog of patent applications, and the approval or rejection of patents may take several years. Prior to actual issuance, the contents of United States patent applications are generally not made public. Once issued, such a patent would constitute prior art from its filing date, which might predate the date of a patent application on which the Company relies. Conceivably, the issuance of such a patent, or the discovery of "prior art" of which the Company is currently unaware, could invalidate a patent of the Company or its licensor or prevent commercialization of a product disclosed therein. 27 28 The Company generally does not conduct an extensive review of issued patents prior to engaging in research or development activities. Accordingly, the Company may be required to obtain a license from others to commercialize any of its products under development. There can be no assurance that any such license that may be required could be obtained on favorable terms or at all. In addition, if patents that cover LifeCell's existing activities are issued to other companies, there can be no assurance that LifeCell would be able to obtain licenses to such patents at a reasonable cost, if at all, or be able to develop or obtain alternative technology. Any of the foregoing matters could have a material adverse effect on LifeCell and on its business prospects. In addition, the Company may be required to obtain a license under one or more patents prior to commercializing any heart valve or vascular product, if developed. There can be no assurance that such a license will be available, or if available, that a license will be granted on terms which are commercially acceptable to the Company. In November 1997, Integra and MIT filed a lawsuit in the United States District Court for the District of Massachusetts, alleging that the Company infringes one or more claims of the Integra Patents. The lawsuit seeks injunctive relief, an accounting of revenues, treble and other monetary damages and attorneys' fees. LifeCell filed a response to the complaint denying the infringement claims and asserting certain affirmative defenses and counterclaims. The Company has received an opinion from its patent counsel to the effect that the current uses of AlloDerm do not infringe the Integra Patents. This opinion represents only the reasoned professional judgment of the Company's patent counsel and is not binding on any court or third party. Patent litigation involves complex legal and factual questions. As a result, the outcome of such litigation is inherently unpredictable, and there can be no assurance that the result of this proceeding will be favorable to the Company or that it will not have a material adverse effect on the Company's business, operating results or financial condition. In addition, no assurances may be given that the Company's existing or proposed products or processes may not be the subject of additional infringement claims. Any successful patent infringement claim relating to any patent could have a material adverse effect on the Company. See "--Patent Infringement Lawsuit." There can be no assurance that LifeCell will not be required to resort to litigation to protect its patented technologies or other proprietary rights or that the Company will not be the subject of additional patent litigation to defend its existing or proposed products or processes against claims of patent infringement or other intellectual property claims. Any of such litigation could result in substantial costs and diversion of resources and could have a material adverse effect on the Company's business, financial condition and results of operations. LifeCell also has applied for patent protection in several foreign countries. Because of the differences in patent laws and laws concerning proprietary rights, the extent of protection provided by United States patents or proprietary rights owned by or licensed to LifeCell may differ from that of their foreign counterparts. LifeCell may decide for business reasons to retain certain knowledge that it considers proprietary as confidential and elect to protect such information as a trade secret, as business confidential information or as know-how. In that event, LifeCell must rely upon trade secrets, know-how and continuing technological innovation to maintain its competitive position. There can be no assurance that others will not independently develop substantially equivalent proprietary information or otherwise gain access to or disclose such information. The independent development or disclosure of LifeCell's trade secrets could have a material adverse effect on LifeCell and on its business prospects. See "--Patents, Proprietary Information and Trademarks." PRODUCT LIABILITY AND INSURANCE The Company's business exposes it to potential product liability risks which are inherent in the testing, manufacturing and marketing of medical products. Although the Company has product liability insurance coverage with an aggregate limit of $5.0 million and a per occurrence limit of $3.0 million, there can be no assurance that such insurance will provide adequate coverage against potential liabilities, that adequate product liability insurance will continue to be available in the future or that it can be maintained on acceptable terms. The obligation to pay any product liability claim in excess of whatever insurance the Company is able to acquire could have a material adverse effect on the business, financial condition and results of operations of the Company. The Company uses donated human skin as the raw material for AlloDerm. The non-profit organizations that supply such skin are required to follow FDA regulations and guidelines published by the American Association of Tissue Banks to screen donors for potential disease transmission. Such procedures include donor testing for certain viruses, including HIV. The Company's manufacturing process also has been demonstrated to inactivate concentrated suspensions of HIV in 28 29 tissue. While the Company believes such procedures are adequate to reduce the threat of disease transmission, there can be no assurance that its AlloDerm product will not be associated with transmission of disease or that a patient otherwise infected with disease would not erroneously assert a claim that the use of AlloDerm resulted in the disease transmission. Any such transmission or alleged transmission could have a material adverse effect on the Company's ability to manufacture or market its products or could otherwise have a material adverse effect on the Company's business, financial condition or results of operations. See "--Risk Factors--Dependence on Certain Sources of Materials." LIMITATION ON THE USE OF NET OPERATING LOSSES AND RESEARCH AND DEVELOPMENT TAX CREDITS As of December 31, 1997, LifeCell had accumulated net operating loss ("NOL") carryforwards for federal income tax purposes of approximately $32.1 million and research and development tax credits of approximately $395,000 since its inception, and may continue to incur NOL carryforwards. United States tax laws provide for an annual limitation on the use of NOL carryforwards following certain ownership changes and also limit the time during which NOL and tax credit carryforwards may be applied against future taxable income and tax liabilities. The sale of Common Stock in the public offering completed in December 1997 resulted in an ownership change for federal income tax purposes. The Company estimates that the amount of its NOL carryforwards and the credits available to offset taxable income subsequent to the offering will be approximately $2.6 million per year on a cumulative basis. Accordingly, if LifeCell generates taxable income in any year in excess of the then cumulative limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. DISPOSAL OF HAZARDOUS MATERIALS LifeCell's research and development and processing techniques generate waste that is classified as hazardous by the United States Environmental Protection Agency and the Texas Natural Resources Commission. LifeCell segregates such waste and disposes of it through a licensed hazardous waste transporter. Although LifeCell believes it is currently in compliance in all material respects with applicable environmental regulations, its failure to comply fully with any such regulations could result in the imposition of penalties, fines or sanctions that could have a material adverse effect on LifeCell's business, financial condition and results of operations. See "--Government Regulation." POSSIBLE VOLATILITY OF STOCK PRICE The market price of the shares of Common Stock, like that of the common stock of many other medical products and high technology companies, has in the past been, and is likely in the future to continue to be, highly volatile. Factors such as fluctuations in the Company's operating results, announcements of technological innovations or new commercial products by the Company or competitors, government regulation, developments in or disputes regarding patent or other proprietary rights, economic and other external factors and general market conditions may have a significant effect on the market price of the Common Stock. Moreover, the stock market has from time to time experienced extreme price and volume fluctuations which have particularly affected the market prices for medical products and high technology companies and which have often been unrelated to the operating performance of such companies. These broad market fluctuations, as well as general economic, political and market conditions, may adversely affect the market price of Common Stock. POSSIBLE ANTI-TAKEOVER EFFECTS Certain provisions of LifeCell's Restated Certificate of Incorporation, as amended (the "Restated Certificate of Incorporation") and Amended and Restated By-laws (the "By-laws") and Section 203 of the Delaware General Corporation Law may have the effect of deterring hostile takeovers or delaying or preventing changes in control or management of the Company, including transactions in which stockholders might otherwise receive a premium for their shares over the current market prices. In addition, these provisions may limit the ability of stockholders to approve transactions that they may deem to be in their best interests. For example, provisions contained in the Restated Certificate of Incorporation and By-laws include authorized blank check preferred stock, the denial of cumulative voting, limitation of the persons who may call a special meeting of the stockholders and advance notice requirement for election to the Board of Directors. 29 30 RIGHTS OF HOLDERS OF SERIES B PREFERRED STOCK As of December 31, 1997, there were 125,441 shares of Series B Preferred Stock outstanding. Such shares are convertible at any time at the option of the holders thereof and automatically under certain circumstances into approximately 4,046,483 shares of Common Stock. On all matters submitted to a vote of the stockholders of the Company, each share of Series B Preferred Stock entitles the holder thereof to one vote for each share of Common Stock into which such share of Series B Preferred Stock is then convertible. The holders of the shares of Series B Preferred Stock have the right to elect up to three directors of the Company. In the event of any liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, the holders of shares of Series B Preferred Stock will be entitled to receive out of the assets of the Company available for distribution to stockholders, before any distribution of assets is made to holders of Common Stock, an amount equal to $100.00 per share of Series B Preferred Stock. After payment of the full amount of any liquidating distribution to which they are entitled, the holders of shares of Series B Preferred Stock will be entitled to share ratably (treating all then issued and outstanding shares of Series B Preferred Stock as if such shares had been converted into Common Stock) in any further distribution of assets by the Company to the holders of Common Stock. Holders of the Series B Preferred Stock are entitled to receive dividends through September 30, 2001. The Company may at its option pay such dividends in additional shares of Series B Preferred Stock. ITEM 2. PROPERTIES LifeCell leases approximately 25,000 square feet of laboratory, office and warehouse space at its facilities in The Woodlands, Texas, under lease agreements that expire in January 2001. The Company's monthly rental obligation for its facilities is approximately $24,000. ITEM 3. LEGAL PROCEEDINGS In November 1997, Integra and MIT filed a lawsuit in the United States District Court for the District of Massachusetts, alleging that the Company infringes the Integra Patents. The lawsuit seeks injunctive relief, an accounting of revenues, treble and other monetary damages and attorneys' fees. LifeCell filed a response to the complaint denying the infringement claims and asserting certain affirmative defenses and counterclaims. The Company has received an opinion from its patent counsel to the effect that the current uses of AlloDerm do not infringe the Integra Patents. This opinion represents only the reasoned professional judgment of the Company's patent counsel and is not binding on any court or third party. Patent litigation involves complex legal and factual questions. As a result, the outcome of such litigation is inherently unpredictable, and there can be no assurance that the result of this proceeding will be favorable to the Company or that it will not have a material adverse effect on the Company's business, operating results or financial condition. If it is determined that the Company is infringing the Integra Patents, the court could issue an injunction prohibiting the Company from making, using or selling its AlloDerm product for some or all of its intended uses. Such injunction could also extend to the Company's other potential products under development. In addition, the court could assess significant damages and attorneys' fees against the Company, which would have a material adverse effect on the Company's business, operating results and financial condition and otherwise affect the ability of the Company to continue as a viable enterprise. In addition, an adverse determination in this proceeding could require the Company to seek licenses from Integra, which may not be available on reasonable terms, if at all. Regardless of the outcome, defending such claims could involve significant costs and diversion of management resources, which could have a material adverse effect on the Company's business, operating results or financial condition. See "Business--Risk Factors--Patent Infringement Lawsuit" and "Business--Risk Factors--Dependence on Patents and Proprietary Rights." In December 1997, LifeCell filed a lawsuit in Texas state court against Integra LifeSciences Corporation and the Massachusetts Institute of Technology alleging that they tortiously interfered with certain of LifeCell's business relationships, including relationships with investors and potential investors in LifeCell's recent public offering. The lawsuit also alleges anticompetitive acts and business disparagement. LifeCell is seeking injunctive relief and actual, treble and punitive damages. Such a suit can be costly to litigate and there is no assurance that it will have a favorable outcome to the Company or that any damages will be obtained. ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. 30 31 PART II ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS The Company's Common Stock is listed on the Nasdaq SmallCap Market under the symbol "LIFC." On March 2, 1998, the last reported sale price for the Company's Common Stock on The Nasdaq SmallCap Market was $5.00 per share. The following table sets forth the high and low sales information for the Company's Common Stock for the periods indicated, as reported by The Nasdaq Stock Market.
High Low 1996 First Quarter......................... $6.00 $2.25 Second Quarter....................... 5.00 3.75 Third Quarter........................ 5.88 3.09 Fourth Quarter....................... 4.25 2.88 1997 First Quarter........................ $8.88 $3.06 Second Quarter....................... 7.13 4.63 Third Quarter........................ 8.38 4.81 Fourth Quarter....................... 8.25 3.50
As of February 28, 1998, there were approximately 280 holders of record of shares of Common Stock and 49 holders of record of shares of Series B Preferred Stock. The Company estimates that there are in excess of 2,000 beneficial holders of its Common Stock. During 1997, the Company issued a total of 74,786 shares of Common Stock for an aggregate consideration of $308,866 to various stockholders of the Company pursuant to the exercise of certain stock purchase warrants. Additionally, during 1997, the Company issued 2,027 shares of Common Stock in exchange for a warrant to purchase 15,000 shares of Common Stock. None of such issuances involved underwriters. The Company considers these securities to have been offered and sold in transactions not involving a public offering and, therefore, to be exempted from registration under Section 4(2) of the Securities Act of 1933, as amended. DIVIDEND POLICY LifeCell has not paid a cash dividend to holders of shares of Common Stock and does not anticipate paying cash dividends to the holders of its Common Stock in the foreseeable future. Pursuant to the terms of the Company's Series A Preferred Stock, on (i) December 6, 1996, the Company paid a per share dividend of $1.60 in shares of Common Stock to the holders of the Series A Preferred Stock; (ii) March 26, 1997, the Company paid a per share dividend of $0.50 in shares of Common Stock to such security holders; and (iii) March 26, 1997, the Company paid a per share dividend of $0.25 in cash to such security holders. Also on March 26, 1997, in accordance with the terms of the Series A Preferred Stock, the Company redeemed all of the outstanding shares of the Series A Preferred Stock through the conversion of such shares into shares of Common Stock. Accordingly, no further dividends are payable in respect of the Series A Preferred Stock. On February 15, 1997, May 15, 1997, August 15, 1997, and November 17, 1997, the Company paid a per share dividend in shares of its Series B Preferred Stock equivalent to $1.17, $2.41, $1.50 and $1.51, respectively, to the holders of shares of Series B Preferred Stock. On February 17, 1998, the Company paid a $1.51 per share dividend in cash to the holders of shares of Series B Preferred Stock. The Series B Preferred Stock bears dividends per share at the annual rate of the greater of (i) $6.00 (subject to adjustment in certain events) and (ii) the per annum rate of dividends per share paid, if applicable, by the Company, on the Common Stock. The dividends may be paid, at the Company's option, in cash or shares of Series B Preferred Stock or in a combination of cash and shares of Series B Preferred Stock. Dividends on the Series B Preferred Stock accrue and are paid quarterly. The Series B Preferred Stock ceases bearing dividends on September 30, 2001. Under the General Corporation Law of the State of Delaware, a corporation's board of directors may declare and pay dividends only out of surplus, including additional paid in capital, or current net profits. 31 32 ITEM 6. SELECTED FINANCIAL DATA The following table sets forth certain selected financial data of LifeCell for each of the years in the five-year period ended December 31, 1997, derived from the Company's audited financial statements. This information should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the Financial Statements and notes thereto included elsewhere in this Annual Report on Form 10-K.
Year Ended December 31, 1993 1994 1995 1996 1997 ------------ ------------ ------------ ------------- ------------ Operations Statement Data: - -------------------------- Revenues: Product sales ............... $ 20,737 $ 93,940 $ 742,238 $ 2,012,205 $ 4,904,971 Research funded by others ... 377,057 722,675 1,064,337 933,365 1,074,954 ------------ ------------ ------------ ------------ ------------ Total revenues ........... 397,794 816,615 1,806,575 2,945,570 5,979,925 ------------ ------------ ------------ ------------ ------------ Costs and expenses: Cost of goods sold .......... 207,398 515,500 925,174 1,281,353 2,540,644 Research and development .... 2,095,856 2,085,851 2,169,764 1,588,186 2,007,062 General and administrative .. 1,479,327 1,381,470 1,422,588 1,911,254 3,081,512 Selling and marketing ....... 268,618 727,615 1,475,296 2,389,573 4,955,597 ------------ ------------ ------------ ------------ ------------ Total costs and expenses . 4,051,199 4,710,436 5,992,822 7,170,366 12,584,815 ------------ ------------ ------------ ------------ ------------ Loss from operations ........... (3,653,405) (3,893,821) (4,186,247) (4,224,796) (6,604,890) ------------ ------------ ------------ ------------ ------------ Interest income and other ... 223,973 167,300 280,843 135,082 466,255 ------------ ------------ ------------ ------------ ------------ Net loss ....................... $ (3,429,432) $ (3,726,521) $ (3,905,404) $ (4,089,714) $ (6,138,635) Loss per share(1)-basic and diluted ..................... $ (0.80) $ (0.90) $ (1.10) $ (1.14) $ (1.04) ============ ============ ============ ============ ============ Shares used in computing loss per share-basic and diluted . 4,277,171 4,294,179 4,313,366 4,542,519 6,820,122 ============ ============ ============ ============ ============ Year Ended December 31, 1993 1994 1995 1996 1997 ------------ ------------ ------------ ------------- ------------ Balance Sheet Data: - ------------------- Cash and cash equivalents ...... $ 426,104 $ 1,877,295 $ 3,015,332 $ 10,748,250 $ 20,781,026 Short-term investments ......... 3,016,511 5,154,824 -- -- -- Working capital ................ 3,433,008 6,613,304 2,888,048 10,884,779 20,515,559 Total assets ................... 4,260,079 7,997,404 4,376,039 12,890,015 24,155,598 Long-term obligations .......... -- 1,500,000 1,500,000 1,500,000 1,500,000 Accumulated deficit ............ (16,618,635) (20,678,402) (24,774,753) (29,310,934) (36,411,480) Total stockholders' equity ..... 4,045,661 5,743,127 2,093,906 10,197,104 20,259,603
(1) Includes effect of accounting treatment of preferred stock and warrants of $0.03, $0.19, $0.24 and $0.14 in 1994, 1995, 1996 and 1997, respectively. ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of operations and financial condition of LifeCell should be read in conjunction with the Financial Statements and Notes thereto included elsewhere in this Annual Report on Form 10-K. Special Note: Certain statements set forth below constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. See "Business--Special Note Regarding Forward-Looking Statements." 32 33 GENERAL AND BACKGROUND LifeCell was organized in 1986 and, since its inception, has been financed through the public and private sale of equity securities, through product sales, through a corporate alliance with Medtronic and through the receipt of government grants and contracts. LifeCell began the sale of AlloDerm grafts as a dermal replacement in the grafting of third-degree burns in December 1993 and commenced commercial activities in 1994. LifeCell commenced the sale of AlloDerm for periodontal surgery in September 1995 and for reconstructive plastic surgery in November 1995. To date, proceeds from the sale of AlloDerm products have not been sufficient to fund in full the Company's operating activities. RESULTS OF OPERATIONS YEAR ENDED DECEMBER 31, 1997 AND 1996 The net loss for the year ended December 31, 1997, increased 50% to approximately $6.1 million compared to approximately $4.1 million for the same period of 1996. The increase was principally attributable to costs associated with expanding the sales of AlloDerm, including the development of sales and marketing programs, recruitment and retention of staff and the related infrastructure necessary to support such activities. Total revenues for the year ended December 31, 1997, increased 103% to approximately $6.0 million compared to approximately $2.9 million for the same period of 1996. Approximately $2.9 million of such increase was attributable to increases in sales of products, which were the result of expanded sales and marketing activities and increased distribution activities during the 1997 period. The remaining $142,000 increase in revenues was the result of increased research activities under funding arrangements; amounts recognized as revenues under such cost-reimbursement arrangements are for the associated expenses incurred during the periods. Cost of goods sold for the year ended December 31, 1997, was approximately $2.5 million, resulting in a gross margin of approximately 48%. The gross margin for the year ended December 31, 1996, was approximately 36%. The increase in gross margin was principally attributable to the implementation of certain production efficiencies, the allocation of fixed costs to higher volumes of products, an increase in sales of certain higher-margin AlloDerm products and an increase in the price of certain AlloDerm products in 1997. Research and development expenses for the year ended December 31, 1997, increased 26% to approximately $2.0 million compared to approximately $1.6 million for 1996. Of such increase, approximately $142,000 was attributable to increased activities related to research funded by others. Such activities increased in 1997 as a result of the receipt during 1996 of three contracts with government agencies to fund research and development activities. The remaining $277,000 increase in research and development expense was attributable to increased production of products for clinical and research activities as well as higher allocations of resources to certain proprietary research and development programs. General and administrative expenses for the year ended December 31, 1997, increased 61% to approximately $3.1 million compared to approximately $1.9 million for 1996. Such increase was principally attributable to legal fees accrued for the defense of the patent infringement lawsuit, increased staff levels, recruiting fees and other professional fees related to the Company's expansion of the infrastructure to support its increased sales activities. Selling and marketing expenses increased 107% to approximately $5.0 million for the year ended December 31, 1997, compared to approximately $2.4 million for 1996. The increase was primarily attributable to increased promotional activities as well as the addition of sales personnel related to AlloDerm marketing. Interest income and other, net increased 245% to approximately $466,000 for the year ended December 31, 1997, compared to approximately $135,000 for 1996. The increase was principally attributable to higher funds available for investment during the current period as a result of the sale of Series B Preferred Stock in November 1996 and the proceeds received from the public offering of Common Stock in December 1997. YEARS ENDED DECEMBER 31, 1996 AND 1995 Total revenues for 1996 increased 63% to approximately $2.9 million compared to approximately $1.8 million for 1995. As a result of increased marketing activities, expansion of distribution channels and expanded 33 34 uses of the Company's AlloDerm product, product sales for the year increased 171% to $2.0 million from $742,000 for 1995. Revenue from research funded by others decreased 12% to $933,000 from $1.1 million for 1995, principally as a result of lower revenues under the Medtronic arrangement, offset by higher revenues under government grants. The Company received two new grants in 1996 for its ThromboSol and composite skin programs. Total costs and expenses for 1996 increased 20% to $7.2 million, compared to $6.0 million for the same period of the prior year principally as a result of expanded sales and marketing activities for the Company's products and costs related to such expanded activities. Cost of goods sold for 1996 increased 38% to $1.3 million compared to $925,000 in the same period of 1995. This increase was due to an increase in product sales and the shift from the development of AlloDerm to processing, consistent with taking a product to market. Total research and development expenses decreased 27% to $1.6 million in 1996 from $2.2 million in 1995 as a result of lower expenditures under its research funded by others as well as the shift in the Company's focus from the development of AlloDerm to processing. General and administrative expense increased 34% to $1.9 million in 1996, from $1.4 million in 1995 principally as a result of expanded administrative activities as the Company increased its product sales and marketing activities as well as certain administrative expenses recognized in conjunction with its 1996 financing activities and non-cash charges related to the reissuance of certain stock options. Selling and marketing expenses increased 62% to $2.4 million for 1996 from $1.5 million in 1995 primarily due to the addition of sales personnel and promotional activities related to AlloDerm marketing and expanded distribution activities. Interest income and other, net decreased 52% to $135,000 for 1996 compared to $281,000 for 1995 as a result of the decrease in funds available for investment prior to the receipt of funds from an equity financing in late 1996, as well as lower interest rates in 1996. LIQUIDITY AND CAPITAL RESOURCES Since its inception, LifeCell's principal sources of funds have been equity offerings, product sales, external funding of research activities and interest on investments. LifeCell has historically funded research and development activities for products other than AlloDerm primarily with external funds from its corporate alliance with Medtronic and government grants. In April 1996, LifeCell was awarded a $613,000 contract from the United States Navy related to the development of ThromboSol. In August 1996, LifeCell was awarded a two-year $300,000 National Science Foundation grant related to its keratinocytes program. In December 1996, LifeCell was awarded a two-year contract of approximately $1.1 million from the United States Army to support the development of vascular graft and other products. In 1994, LifeCell entered into an agreement with Medtronic pursuant to which Medtronic paid LifeCell a license fee of $1.5 million and agreed, subject to certain rights to terminate at Medtronic's discretion, to fund certain costs of the research and development of LifeCell's proprietary tissue processing technology in the field of heart valves. Through December 31, 1997, LifeCell has recognized approximately $1.9 million in revenues for development funding, excluding the initial license fee, for this program. In November 1996, LifeCell received net proceeds of approximately $10.9 million pursuant to the private sale of Series B Preferred Stock and warrants exercisable for the purchase of Common Stock. In December 1997, LifeCell received net proceeds of approximately $16.0 million pursuant to a public offering of 4.0 million shares of Common Stock. In November 1997, Integra and MIT filed a lawsuit against the Company alleging that the use of AlloDerm infringes the Integra Patents. Although the Company denies the allegations of patent infringement, there can be no assurance as to the outcome of this matter or as to the effect, if any, that the outcome may have on the Company's business, financial condition or results of operations. See "Business--Risk Factors--Patent Infringement Lawsuit" and "Business--Risk Factors--Dependence on Patents and Proprietary Rights." 34 35 In December 1997, LifeCell filed a lawsuit in Texas state court against Integra LifeSciences Corporation and MIT alleging that they tortiously interfered with certain of LifeCell's business relationships, including relationships with investors and potential investors in LifeCell's recent public offering. There can be no assurance as to the outcome of this matter or as to the effect, if any, that the outcome may have on the Company's business, financial condition or results of operations. See "Legal Proceedings." LifeCell expects to incur substantial expenses in connection with its efforts to expand sales and marketing of AlloDerm, develop expanded uses for AlloDerm, conduct the Company's product development programs (including costs of clinical studies), prepare and make any required regulatory filings, introduce products, participate in technical seminars and support ongoing administrative and research and development activities and may incur substantial expenses in connection with defending the lawsuit relating to the Integra Patents and pursuing its tortious interference claims against Integra and MIT. The Company currently intends to fund these activities from its existing cash resources, sales of products and research and development funding received from others. While the Company believes that its existing available funds will be sufficient to meet its present operating and capital requirements through at least 1999, there can be no assurance that such sources of funds will be sufficient to meet these future expenses. If adequate funds are not available, the Company expects it will be required to delay, scale back or eliminate one or more of its product development programs. The Company's need for additional financing will be principally dependent on the degree of market acceptance achieved by the Company's products and the extent to which the Company can achieve substantial growth in product sales during 1998 and 1999, as well as the extent to which the Company may decide to expand its product development efforts. There can be no assurance that the Company will be able to obtain any such additional financing on acceptable terms, if at all. See "Business--Risk Factors--No Assurance of Additional Necessary Capital." LifeCell has had losses since its inception and therefore has not been subject to federal income taxes. As of December 31, 1997, LifeCell had net operating loss ("NOL") and research and development tax credit carryforwards for income tax purposes of approximately $32.1 million and $395,000, respectively, available to reduce future income tax and tax liabilities. Federal tax laws provide for a limitation on the use of NOL and tax credit carryforwards following certain ownership changes that could limit LifeCell's ability to use its NOL and tax credit carryforwards. The sale of Common Stock in the recent public offering resulted in an ownership change for federal income tax purposes. The Company estimates that the amount of NOL carryforwards and the credits available to offset taxable income subsequent to the offering will be approximately $2.6 million per year on a cumulative basis. Accordingly, if LifeCell generates taxable income in any year in excess of its then cumulative limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK None. ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The financial statements and supplementary financial information required to be filed under this Item are presented commencing on page F-1 of this Annual Report on Form 10-K, and are incorporated herein by reference. ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE None. PART III ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT The information required by this Item will be set forth in the Registrant's Proxy Statement relating to the annual meeting of the Registrant's stockholders scheduled to be held May 27, 1998, under the captions "Election of Directors" and "Executive Compensation," and such information is incorporated herein by reference. 35 36 ITEM 11. EXECUTIVE COMPENSATION The information required by this Item will be set forth in the Registrant's Proxy Statement relating to the annual meeting of the Registrant's stockholders scheduled to be held May 27, 1998, under the caption "Executive Compensation," and such information is incorporated herein by reference. ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The information required by this Item will be set forth in the Registrant's Proxy Statement relating to the annual meeting of the Registrant's stockholders scheduled to be held May 27, 1998, under the caption "Security Ownership of Certain Beneficial Owners and Management," and such information is incorporated herein by reference. ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS The information required by this Item will be set forth in the Registrant's Proxy Statement relating to the annual meeting of the Registrant's stockholders scheduled to be held May 27, 1998, under the caption "Certain Relationships and Related Transactions," and such information is incorporated herein by reference. PART IV ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K (a) DOCUMENTS INCLUDED IN THIS REPORT:
1. FINANCIAL STATEMENTS PAGE Report of Independent Public Accountants....................................................... F-1 Balance Sheets as of December 31, 1996 and 1997................................................ F-2 Statements of Operations for the years ended December 31, 1995, 1996 and 1997.................. F-3 Statements of Stockholders' Equity for the years ended December 31, 1995, 1996 and 1997........ F-4 Statements of Cash Flows for the years ended December 31, 1995, 1996 and 1997.................. F-6 Notes to Financial Statements.................................................................. F-7
(b) REPORTS ON FORM 8-K: None (c) EXHIBITS: Exhibits designated by the symbol * are filed with this Annual Report on Form 10-K. All exhibits not so designated are incorporated by reference to a prior filing as indicated. Exhibits designated by the symbol + are management contracts or compensatory plans or arrangements that are required to be filed with this report pursuant to this Item 14. LifeCell undertakes to furnish to any stockholder so requesting a copy of any of the following exhibits upon payment to the Company of the reasonable costs incurred by Company in furnishing any such exhibit. 3.1* Restated Certificate of Incorporation, as amended. 3.2 Amended and Restated By-laws (incorporated by reference to Exhibit 3.2 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 1996) 36 37 10.1+ LifeCell Corporation Amended and Restated 1992 Stock Option Plan, as amended (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 1997, filed with the Commission on August 12, 1997). 10.2+ LifeCell Corporation Second Amended and Restated 1993 Non-Employee Director Stock Option Plan, as amended (incorporated by reference to Exhibit 10.4 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996, filed with the Commission on March 31, 1997). 10.3 Form of Confidentiality/Non-Compete Agreement (incorporated by reference to Exhibit 10.28 to the Company's Registration Statement on Form S-1, Registration No. 33-44969, filed with the Commission on January 9, 1992). 10.4 Exclusive License Agreement dated June 6, 1986, between the Registrant and The Board of Regents of The University of Texas System (incorporated by reference to Exhibit 10.29 to the Company's Registration Statement on Form S-1, Registration No. 33-44969, filed with the Commission on January 9, 1992). 10.5+ Amended and Restated Registration Rights Agreement dated February 26, 1992, by and between the Registration and the stockholders named therein (incorporated by reference to Exhibit 10.40 to Amendment No. 3 to the Company's Registration Statement on Form S-1, Registration No. 33-44969, filed with the Commission on February 27, 1992). 10.6 Underwriter's Warrant Agreement dated March 6, 1992, between the Registrant and Robert Todd Financial Corporation, and First Amendment to Underwriter's Warrant Agreement dated January 26, 1993, between the Registrant and Robert Todd Financial Corporation (incorporated by reference to Exhibit 10.18 to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1992). 10.7 Lease Agreement dated December 10, 1986, between the Registrant and The Woodlands Corporation, Modification and Ratification of Lease Agreement dated April 11, 1988, between the Registration and The Woodlands Corporation Modification and Ratification of Lease dated August 1, 1992, between the Company and The Woodlands Corporation and Modification, Extension and Ratification of Lease dated March 5, 1993, between the Registrant and The Woodlands Corporation, and Modification and Ratification of Lease Agreement dated December 21, 1995, between the Company and The Woodlands Office Equities -- '95 Limited (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the period ended March 31, 1996). 10.8 Lease Agreement dated September 1, 1988, between the Registrant and The Woodlands Corporation, and Modification of Lease Agreement dated March 5, 1993, between the Registrant and The Woodlands Corporation (incorporated by reference to Exhibit 10.22 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1992). 10.9 Stock Purchase Warrant dated January 26, 1993, issued to Strategem of Alabama, Inc. (incorporated by reference to Exhibit 10.25 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1992). 10.10 License and Development Agreement dated March 3, 1994, between the Registrant and Medtronic, Inc. (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K dated March 3, 1994). 10.11 Investment Agreement dated March 3, 1994, between the Registrant and Medtronic, Inc. (incorporated by reference to Exhibit 10.2 to Company's Current Report on Form 8-K dated March 3, 1994). 10.12 Lease Agreement between LifeCell Corporation and Unichem, dated August 1, 1994 (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q for the period ended September 30, 1994). 10.13 Securities Purchase Agreement dated November 18, 1996, between LifeCell Corporation and the Investors named therein (incorporated by reference to Exhibit 10.15 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 37 38 10.14 Voting Agreement dated November 18, 1996, among LifeCell Corporation and certain stockholders named therein (incorporated by reference to Exhibit 10.16 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.15 Registration Rights Agreement dated November 18, 1996, between LifeCell Corporation and certain stockholders named therein (incorporated by reference to Exhibit 10.17 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.16 Form of Stock Purchase Warrant dated November 18, 1996, issued to each of the warrant holders named on Schedule 10.18 attached thereto (incorporated by reference to Exhibit 10.18 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.17 Stock Purchase Warrant dated November 18, 1996, issued to Gruntal & Co., Incorporated (incorporated by reference to Exhibit 10.19 to Amendment No. 1 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996 on Form 10-K/A). 10.18+ Agreement dated July 1, 1997, between LifeCell Corporation and Paul M. Frison.(incorporated by reference to Exhibit 10.20 to the Company's Registration Statement No. 333-37123 on Form S-2 filed with the Commission on October 3, 1997). 10.19+ Agreement dated July 1, 1997, between LifeCell Corporation and Stephen A. Livesey. (incorporated by reference to Exhibit 10.20 to the Company's Registration Statement No. 333-37123 on Form S-2 filed with the Commission on October 3, 1997). 23.1* Consent of Arthur Andersen LLP. 27.1* Financial data schedule. 38 39 SIGNATURES In accordance with Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. LIFECELL CORPORATION (Registrant) By: /s/ PAUL M. FRISON ---------------------------------------------------- Paul M. Frison, President and Chief Executive Officer and Chairman of the Board of Directors Dated: March 5, 1998. In accordance with the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated:
SIGNATURE TITLE DATE --------- ----- ---- /s/ Paul M. Frison Chairman of the Board, March 5, 1998 - --------------------------- (Paul M. Frison) President and Chief Executive Officer (Principal Executive Officer) /s/ J. Donald Payne Vice President, Secretary March 5, 1998 - --------------------------- (J. Donald Payne) and Chief Financial Officer (Principal Financial Officer) /s/ Lynne P. Hohlfeld Controller March 5, 1998 - --------------------------- (Lynne P. Hohlfeld) (Principal Accounting Officer) /s/ Michael E. Cahr Director March 5, 1998 - --------------------------- (Michael E. Cahr) /s/ James G. Foster Director March 5, 1998 - --------------------------- (James G. Foster) /s/ Lori G. Koffman Director March 5, 1998 - --------------------------- (Lori G. Koffman) /s/ Stephen A. Livesey Director March 5, 1998 - --------------------------- (Stephen A. Livesey) /s/ K. Flynn McDonald Director March 5, 1998 - --------------------------- (K. Flynn McDonald) /s/ David A. Thompson Director March 5, 1998 - --------------------------- (David A. Thompson)
39 40 REPORT OF INDEPENDENT PUBLIC ACCOUNTANTS To LifeCell Corporation: We have audited the accompanying balance sheets of LifeCell Corporation (a Delaware corporation) as of December 31, 1996 and 1997, and the related statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 1997. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of LifeCell Corporation as of December 31, 1996 and 1997, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 1997, in conformity with generally accepted accounting principles. ARTHUR ANDERSEN LLP Houston, Texas February 18, 1998 F-1 41 LIFECELL CORPORATION BALANCE SHEETS
DECEMBER 31, ---------------------------- 1996 1997 ------------ ------------ Assets Current Assets Cash and cash equivalents .................................................. $ 10,748,250 $ 20,781,026 Accounts and other receivables, net ........................................ 436,839 1,095,904 Inventories ................................................................ 839,821 936,398 Prepayments and other ...................................................... 52,780 98,226 ------------ ------------ Total current assets ................................................ 12,077,690 22,911,554 Furniture and Equipment, net ................................................. 478,098 864,058 Intangible Assets, net ....................................................... 334,227 379,986 ------------ ------------ Total assets ........................................................ $ 12,890,015 $ 24,155,598 ============ ============ Liabilities and Stockholders' Equity Current Liabilities Accounts payable ........................................................... $ 514,848 $ 780,393 Accrued liabilities ........................................................ 539,271 1,556,083 Deferred revenues .......................................................... 138,792 59,519 ------------ ------------ Total current liabilities ........................................... 1,192,911 2,395,995 Deferred Credit .............................................................. 1,500,000 1,500,000 Commitments and Contingencies Stockholders' Equity Series A preferred stock, $.001 par value, 300,000 and none shares authorized, 260,000 and none issued and outstanding, including accrued dividends of $86,667 and none, respectively .............. 5,291,473 -- Series B preferred stock, $.001 par value, 182,205 shares authorized, 124,157 and 125,441 issued and outstanding and accrued dividends of 1,426 shares and none, respectively ................... 126 125 Undesignated preferred stock, $.001 par value, 1,517,795 and 1,817,795 shares authorized, none issued and outstanding, respectively ..... -- -- Common stock, $.001 par value, 25,000,000 shares authorized, 4,899,944 and 11,012,906 shares issued and outstanding, respectively ............................................................... 4,900 11,013 Warrants outstanding to purchase 3,378,264 and 3,163,478 shares of common stock, respectively ....................................... 423,218 299,480 Additional paid-in capital ................................................... 33,788,321 56,360,465 Accumulated deficit .......................................................... (29,310,934) (36,411,480) ------------ ------------ Total stockholders' equity .......................................... 10,197,104 20,259,603 ------------ ------------ Total liabilities and stockholders' equity .......................... $ 12,890,015 $ 24,155,598 ============ ============
The accompanying notes are an integral part of these financial statements. F-2 42 LIFECELL CORPORATION STATEMENTS OF OPERATIONS
FOR THE YEAR ENDED DECEMBER 31, -------------------------------------------- 1995 1996 1997 ------------ ------------ ------------ Revenues Product sales ........................ $ 742,238 $ 2,012,205 $ 4,904,971 Research funded by others ............ 1,064,337 933,365 1,074,954 ------------ ------------ ------------ Total revenues ................ 1,806,575 2,945,570 5,979,925 ------------ ------------ ------------ Costs and Expenses Cost of goods sold ................... 925,174 1,281,353 2,540,644 Research and development ............. 2,169,764 1,588,186 2,007,062 General and administrative ........... 1,422,588 1,911,254 3,081,512 Selling and marketing ................ 1,475,296 2,389,573 4,955,597 ------------ ------------ ------------ Total costs and expenses ...... 5,992,822 7,170,366 12,584,815 ------------ ------------ ------------ Loss From Operations ................... (4,186,247) (4,224,796) (6,604,890) ------------ ------------ ------------ Interest income ...................... 280,843 135,082 466,255 ------------ ------------ ------------ Net Loss ............................... $ (3,905,404) $ (4,089,714) $ (6,138,635) ============ ============ ============ Loss Per Common Share--Basic and Diluted $ (1.10) $ (1.14) $ (1.04) ============ ============ ============ Shares Used in Computing Loss Per Common Share--Basic and Diluted ...... 4,313,366 4,542,519 6,820,122 ============ ============ ============
The accompanying notes are an integral part of these financial statements. F-3 43 LIFECELL CORPORATION STATEMENTS OF STOCKHOLDERS' EQUITY
SERIES A SERIES B PREFERRED STOCK PREFERRED STOCK COMMON STOCK -------------------- ----------------- ----------------------- SHARES AMOUNT SHARES AMOUNT SHARES AMOUNT ------ ------ ------ ------ ------ ------ Balance at December 31, 1994 ............. 264,500 $ 5,279,909 -- $ -- 4,297,592 $ 4,298 Warrant issued to purchase common stock ........................ -- -- -- -- -- -- Stock options exercised ................ -- -- -- -- 1,000 1 Warrants exercised ..................... -- -- -- -- 1,250 1 Common stock issued as dividends on Series A preferred stock ......... -- (317,400) -- -- 103,816 104 Earned portion of restricted stock ..... -- -- -- -- -- -- Earned portion of warrants ............. -- -- -- -- -- -- Dividends accrued on preferred stock ... -- 190,947 -- -- -- -- Accretion of preferred stock ........... -- 343,337 -- -- -- -- Net Loss ............................... -- -- -- -- -- -- ----------- ----------- ----------- ----------- ----------- ----------- Balance at December 31, 1995 ............. 264,500 5,496,793 -- -- 4,403,658 4,404 Stock options exercised ................ -- -- -- -- 6,062 6 Warrants exercised ..................... -- -- -- -- 339,066 339 Expiration of warrants ................. -- -- -- -- -- -- Conversion of preferred stock .......... (4,500) (90,000) -- -- 30,104 30 Common stock issued as dividends on Series A preferred stock ......... -- (415,920) -- -- 121,054 121 Earned portion of restricted stock ..... -- -- -- -- -- -- Stock options issued for services ...... -- -- -- -- -- -- Series B preferred stock and common stock warrants issued for cash ...... -- -- 124,157 124 -- -- Dividends accrued on preferred stock ... -- 300,600 -- 2 -- -- Net Loss ............................... -- -- -- -- -- -- ----------- ----------- ----------- ----------- ----------- ----------- Balance at December 31, 1996 ............. 260,000 5,291,473 124,157 126 4,899,944 4,900 Stock options exercised ................ -- -- -- -- 47,987 48 Warrants exercised ..................... -- -- -- -- 76,813 77 Expiration of warrants ................. -- -- -- -- -- -- Redemption of Series A preferred stock . (260,000) (5,200,000) -- -- 1,739,128 1,739 Conversion of Series B preferred stock . -- -- (6,688) (7) 215,729 216 Common stock and cash issued as dividends on Series A preferred stock ............................... -- (195,000) -- -- 33,305 33 Common stock sold in public offering ... -- -- -- -- 4,000,000 4,000 Stock options issued for services ...... -- -- -- -- -- -- Series B preferred stock issued as dividends on Series B preferred stock -- -- 7,972 6 -- -- Dividends accrued on preferred stock ... -- 103,527 -- -- -- -- Net Loss ............................... -- -- -- -- -- -- ----------- ----------- ----------- ----------- ----------- ----------- Balance at December 31, 1997 ............. -- $ -- 125,441 $ 125 11,012,906 $ 11,013 =========== =========== =========== =========== =========== ===========
(continued) The accompanying notes are an integral part of these financial statements. F-4 44 LIFECELL CORPORATION STATEMENTS OF STOCKHOLDERS' EQUITY--(CONTINUED)
UNEARNED PORTION OF WARRANTS TO PURCHASE RESTRICTED STOCK ADDITIONAL TOTAL COMMON STOCK COMPENSATION PAID-IN ACCUMULATED STOCKHOLDERS' SHARES AMOUNT AND WARRANTS CAPITAL DEFICIT EQUITY ------------ ------------ ------------- ------------ ------------ ------------ Balance at December 31, 1994 ................ 515,316 $ 227,060 $ (269,112) $ 21,179,374 $(20,678,402) $ 5,743,127 Warrant issued to purchase common stock ........................... 60,000 -- -- -- -- -- Stock options exercised ................... -- -- -- 2,999 -- 3,000 Warrants exercised ........................ (1,250) (500) -- 4,574 -- 4,075 Common stock issued as dividends on Series A preferred stock ............ -- -- -- 317,198 -- (98) Earned portion of restricted stock ........ -- -- 238,872 -- -- 238,872 Earned portion of warrants ................ -- -- 10,334 -- -- 10,334 Dividends accrued on preferred stock ...... -- -- -- -- (190,947) -- Accretion of preferred stock .............. -- -- -- (343,337) -- -- Net Loss .................................. -- -- -- -- (3,905,404) (3,905,404) ------------ ------------ ------------ ------------ ------------ ------------ Balance at December 31, 1995 ................ 574,066 226,560 (19,906) 21,160,808 (24,774,753) 2,093,906 Stock options exercised ................... -- -- -- 17,274 -- 17,280 Warrants exercised ........................ (339,066) (104,300) -- 1,155,617 -- 1,051,656 Expiration of warrants .................... (15,000) (6,000) -- 6,000 -- -- Conversion of preferred stock ............. -- -- -- 89,970 -- -- Common stock issued as dividends on Series A preferred stock ............ -- -- -- 409,700 -- (6,099) Earned portion of restricted stock ........ -- -- 19,906 -- -- 19,906 Stock options issued for services ......... -- -- -- 150,000 -- 150,000 Series B preferred stock and common stock warrants issued for cash ......... 3,158,264 306,958 -- 10,653,087 -- 10,960,169 Dividends accrued on preferred stock ...... -- -- -- 145,865 (446,467) -- Net Loss .................................. -- -- -- -- (4,089,714) (4,089,714) ------------ ------------ ------------ ------------ ------------ ------------ Balance at December 31, 1996 ................ 3,378,264 423,218 -- 33,788,321 (29,310,934) 10,197,104 Stock options exercised ................... -- -- -- 128,719 -- 128,767 Warrants exercised ........................ (89,786) (123,738) -- 432,527 -- 308,866 Expiration of warrants .................... (125,000) -- -- -- -- -- Redemption of Series A preferred stock ... -- -- -- 5,198,261 -- -- Conversion of Series B preferred stock .... -- -- -- (209) -- -- Common stock and cash issued as dividends on Series A preferred stock .................................. -- -- -- 129,919 -- (65,048) Common stock sold in public offering ...... -- -- -- 16,018,766 -- 16,022,766 Stock options issued for services ......... -- -- -- 12,834 -- 12,834 Series B preferred stock issued as dividends on Series B preferred stock -- -- -- 651,327 (669,749) (18,416) Dividends accrued on preferred stock ...... -- -- -- -- (292,162) (188,635) Net Loss .................................. -- -- -- -- (6,138,635) (6,138,635) ------------ ------------ ------------ ------------ ------------ ------------ Balance at December 31, 1997 ................ 3,163,478 $ 299,480 $ -- $ 56,360,465 $(36,411,480) $ 20,259,603 ============ ============ ============ ============ ============ ============
The accompanying notes are an integral part of these financial statements. F-5 45 LIFECELL CORPORATION
STATEMENTS OF CASH FLOWS FOR THE YEAR ENDED DECEMBER 31, ---------------------------------------- 1995 1996 1997 ------------ ------------ ------------ Cash Flows from Operating Activities Net Loss .............................................. $ (3,905,404) $ (4,089,714) $ (6,138,635) Adjustments to reconcile net loss to net cash used in operating activities -- Depreciation and amortization ..................... 138,518 229,237 225,092 Stock and warrant compensation expense ............ 249,206 169,906 12,834 Change in assets and liabilities -- (Increase) in accounts and other receivables ...... (87,014) (185,330) (659,065) (Increase) in inventories ......................... (243,720) (488,319) (96,576) (Increase) decrease in prepayments and other ...... 11,347 (942) (45,446) Increase in accounts payable and accrued liabilities .................................... 118,494 450,988 1,282,357 (Decrease) in deferred revenues and deferred credit ......................................... (90,638) (40,210) (79,273) ------------ ------------ ------------ Total adjustments ....................................... 96,193 135,330 639,923 ------------ ------------ ------------ Net cash used in operating activities .......... (3,809,211) (3,954,384) (5,498,712) ------------ ------------ ------------ Cash Flows from Investing Activities Capital expenditures .................................. (190,199) (278,673) (597,685) Intangible assets ..................................... (24,354) (57,032) (59,129) Short-term investments ................................ 5,154,824 -- -- ------------ ------------ ------------ Net cash provided by (used in) investing activities .................................. 4,940,271 (335,705) (656,814) ------------ ------------ ------------ Cash Flows from Financing Activities Proceeds from issuance of stock and warrants .......... 6,977 12,029,105 16,460,399 Proceeds from issuance of notes payable ............... -- 370,000 -- Cash dividends paid ................................... -- (6,098) (272,097) Payments of notes payable ............................. -- (370,000) -- ------------ ------------ ------------ Net cash provided by financing activities .................................. 6,977 12,023,007 16,188,302 ------------ ------------ ------------ Net Increase in Cash and Cash Equivalents ............... 1,138,037 7,732,918 10,032,776 Cash and Cash Equivalents at Beginning of Year .......... 1,877,295 3,015,332 10,748,250 ------------ ------------ ------------ Cash and Cash Equivalents at End of Year ................ $ 3,015,332 $ 10,748,250 $ 20,781,026 ============ ============ ============ Supplemental Disclosures of Cash Flow Information: Cash paid during the year for interest ................ $ -- $ 13,766 $ 4,583 ============ ============ ============ Supplemental Schedule of Noncash Financing Activities: Common Stock issued as payment of dividends ........... $ 317,400 $ 415,920 $ 195,000 ============ ============ ============ Series B Preferred stock issued as payment of dividends $ -- $ -- $ 797,200 ============ ============ ============
The accompanying notes are an integral part of these financial statements. F-6 46 LIFECELL CORPORATION NOTES TO FINANCIAL STATEMENTS DECEMBER 31, 1997 1. ORGANIZATION: LifeCell Corporation, a Delaware corporation ("LifeCell" or "the Company"), is a bioengineering company engaged in the development and commercialization of tissue regeneration and cell preservation products. The Company was incorporated on January 6, 1992 for the purpose of merging with its predecessor entity, which was formed in 1986. LifeCell began commercial sales of its first product, AlloDerm(R) acellular dermal graft, during 1994. The future operating results of the Company will be principally dependent on the market acceptance of its current product, development of and market acceptance of future products, competition from other products or technologies, protection of the Company's proprietary technology, and access to funding as required. Accordingly, there can be no assurance of the Company's future success. See "Business--Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" elsewhere herein. 2. ACCOUNTING POLICIES: Cash and Cash Equivalents and Short-term Investments The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Investments with longer maturities that the Company intends to hold to maturity are classified as either current or non-current assets based on the maturity date of the security. As of December 31, 1996 and 1997, the Company held $10,638,981 and $20,427,627, respectively, of interest-bearing money market accounts and A1/P1 commercial paper which were classified as "held to maturity" securities. The carrying basis of these investments approximated fair value and amortized cost. The securities held at December 31, 1997, matured prior to January 30, 1998. Inventories Inventories are stated at the lower of cost or market, cost being determined on a first-in, first-out (FIFO) basis. Furniture and Equipment Furniture and equipment are stated at cost. Maintenance and repairs that do not improve or extend the life of the assets are expensed as incurred. Expenditures for renewals and improvements are capitalized. The cost of assets retired and the related accumulated depreciation are removed from the accounts and any gain or loss is included in the results of operations. Depreciation of furniture and equipment is provided on the straight-line method based on the estimated useful lives of the assets of five years. Leasehold improvements are depreciated over the life of the lease. Intangible Assets Intangible assets primarily consist of the costs of obtaining patents for the proprietary technology owned by or licensed to the Company. These costs are being amortized over the lesser of the legal (generally 17 years) or the estimated economic life of the patent. Accumulated amortization at December 31, 1996 and 1997, amounted to $53,033 and $66,673, respectively. Allowance for Doubtful Accounts The Company provides an allowance for specific accounts receivable that it believes may not be fully collectible. An allowance of $83,690 was established during 1997. Revenue Recognition Product sales are recognized as revenue when the product is shipped to fill customer orders. Revenues from research funded by others are recognized as the work is performed unless the Company has continuing F-7 47 performance obligations, in which case revenue is recognized upon the satisfaction of such obligations. Revenue received, but not yet earned, is classified as deferred revenue. Research and Development Expense Research and development costs are expensed when incurred. The Company performs research funded by others, including research funded through the corporate alliance with Medtronic (see Note 9), as well as its own independent proprietary research, development and clinical testing of its products. Sales and Marketing Expense Sales and marketing costs include salaries, commissions, advertising and promotional costs related to the sale of the Company's products. Advertising costs are expensed as incurred. The cost of promotional activities, including free goods, product samples and promotional allowances, are expensed as incurred. Loss Per Common Share Loss per Common share has been computed by dividing net loss, which has been increased for periodic accretion and imputed and stated dividends on outstanding Preferred Stock and the discount offered on warrant exercises induced during 1996, by the weighted average number of shares of Common Stock outstanding during each period. In all applicable years, all Common Stock equivalents, including the Series A Preferred Stock and the Series B Preferred Stock, were antidilutive and, accordingly, were not included in the computation. During 1997, the Company adopted Statement of Financial Accounting Standards No. 128, "Earnings Per Share," and all prior periods have been retroactively adjusted to conform to this statement. The implementation of Statement 128 had no effect on the Company's presentation of earnings per share due to the antidilutive nature of all of the Company's Common Stock equivalents. Basic loss per Common share was calculated as follows:
1995 1996 1997 ----------- ----------- ----------- Net Loss .............................................. $(3,905,404) $(4,089,714) $(6,138,635) Less: Preferred dividends, accretion of preferred stock and warrant exercises ............................. (851,684) (1,071,035) (961,911) ----------- ----------- ----------- Net Loss available to common shareholders--basic ...... $(4,757,088) $(5,160,749) $(7,100,546) =========== =========== =========== Weighted average shares outstanding--basic ............ 4,313,366 4,542,519 6,820,122 =========== =========== =========== Loss per Common Share--basic .......................... $ (1.10) $ (1.14) $ (1.04) =========== =========== ===========
Diluted loss per Common share is the same as basic loss per share due to the antidilutive nature of all of the Company's Common Stock equivalents. Stock-Based Compensation The Company accounts for employee stock-based compensation pursuant to the provisions of Accounting Principles Board Opinion No. 25. Compensation expense for stock options issued to employees and directors is generally recorded at the intrinsic value of the option at the date of grant (the discount, if any, of the option price from the market price of the Common Stock under option). Subsequent changes in the market price of the underlying stock do not affect the accounting treatment of the option. Subsequent to 1995, options granted to others are accounted for under the provisions of Statement of Financial Accounting Standards No. 123, which requires that the estimated fair value of the option be estimated using option-pricing formulas used in the financial markets and amortized over the period of expected service to the Company. Use of Estimates The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. F-8 48 3. INVENTORIES: Inventories consist of products in various stages produced for sale and includes the costs of raw materials, labor, and overhead. A summary of inventories is as follows:
1996 1997 -------- -------- Raw materials used in production ............ $189,376 $428,406 Work-in-process ............................. 300,583 228,071 Finished goods .............................. 349,862 279,921 -------- -------- Total inventories ......................... $839,821 $936,398 ======== ========
4. FURNITURE AND EQUIPMENT: A summary of furniture and equipment is as follows:
1996 1997 ----------- ----------- Office furniture and fixtures ........... $ 61,130 $ 120,548 Machinery and equipment ................. 1,342,243 1,748,956 Leasehold improvements .................. 220,293 334,282 ----------- ----------- 1,623,666 2,203,786 Accumulated depreciation and amortization (1,145,568) (1,339,728) ----------- ----------- Net furniture and equipment ........... $ 478,098 $ 864,058 =========== ===========
5. ACCRUED LIABILITIES: Accrued liabilities consist of the following:
1996 1997 ---------- ---------- Employee compensation and benefits .......... $ 301,305 $ 399,498 Operating expenses and other ................ 237,966 468,670 Litigation costs ............................ -- 374,635 Public offering costs ....................... -- 313,280 ---------- ---------- Total accrued liabilities ................. $ 539,271 $1,556,083 ========== ==========
6. CAPITAL STOCK: Authorized Capital Stock As of December 31, 1997, the authorized capital of the Company consisted of 25,000,000 shares of Common Stock, $.001 par value, and 2,000,000 shares of Preferred Stock, $.001 par value, of which 182,205 shares were designated as Series B Preferred Stock. As of December 31, 1997, there were 11,012,906 shares of Common Stock and 125,441 shares of Series B Preferred Stock outstanding. Series A Preferred Stock During November 1994, the Company issued 264,500 shares of Series A Convertible Preferred Stock (Series A Preferred Stock) and warrants to acquire 264,500 shares of Common Stock for gross proceeds of approximately $5.3 million in a private placement. Each share of Series A Preferred Stock was convertible at any time at the option of the holder into 6.69 shares of Common Stock. During 1996, 4,500 shares of Series A Preferred Stock were converted into 30,104 shares of Common Stock. The Series A Preferred Stock bore dividends at annual rates of $1.20, $1.60, and $2.00 per share for each of the first, second and third years, respectively, after the date of original issuance. Dividends were payable in cash, Common Stock, or any combination of cash and Common Stock at the Company's discretion. The Series A Preferred Stock had no ordinary voting rights. During 1995 and 1996, respectively, the Company paid $317,400 and $415,920 in accrued dividends on the Series A Preferred Stock by issuing 103,816 and 121,054 shares of Common Stock, respectively. During 1997, the Company paid $195,000 in accrued dividends by issuing 33,305 shares of Common Stock and paying a cash dividend of $65,000. F-9 49 The preferred stock was automatically convertible into Common Stock on November 9, 1997, and could be redeemed sooner by the Company if, after November 9, 1995, the closing bid price of the Company's Common Stock averaged or exceeded $5.17 per share for 20 consecutive days. Pursuant to such provisions, during February 1997, the Company called for redemption of all outstanding shares of Series A Preferred Stock. During March 1997 the Company issued 1,739,128 shares of Common Stock to redeem the Series A Preferred Stock. Series B Preferred Stock During November 1996, the Company issued 124,157 shares of Series B Preferred Stock ("Series B Preferred Stock") and warrants to acquire 2,803,530 shares of Common Stock for gross proceeds of approximately $12.4 million in a private placement. Each share of Series B Preferred Stock is initially convertible at any time at the option of the holder into approximately 32.26 shares of Common Stock (or 4,046,483 shares of Common Stock at December 31, 1997), subject to adjustment for dilutive issuances of securities. The Series B Preferred Stock has a liquidation preference of $100 per share, or $12,544,100 as of December 31, 1997, and shares ratably in any residual assets after payment of such liquidation preference. The Series B Preferred Stock bears cumulative dividends, payable quarterly, for five years at the greater of the annual rate of $6.00 per share or the rate of any dividends paid on other series of stock (effectively $10 per share until the Series A Preferred Stock was redeemed in March 1997). Dividends may be paid in cash, in additional shares of Series B Preferred Stock based on the stated value of $100 per share, or any combination of cash and Series B Preferred Stock at the Company's option. On all matters for which the Company's stockholders are entitled to vote, each share of Series B Preferred Stock will entitle the holder to one vote for each share of Common Stock into which the share of Series B Preferred Stock is then convertible. Additionally, the holders of Series B Preferred Stock have the right to elect up to three directors to the Board of Directors of the Company. While the preferred shares are outstanding or any dividends are owned thereon, the Company may not declare or pay cash dividends on its Common Stock. During 1997, the Company paid accrued dividends on the Series B Preferred Stock of $815,616 through the issuance of 7,972 additional shares of Series B Preferred Stock and $18,416 cash. The Company has accrued a dividend at December 31, 1997, of $188,635 which was paid in cash on February 17,1998. The preferred stock will be automatically converted into Common Stock if (i) the closing price of the Company's Common Stock averages or exceeds $9.30 per share for 30 consecutive trading days and (ii) the Company conducts an underwritten public offering of newly issued Common Stock with proceeds, net of underwriting discounts and commissions, exceeding $20 million. Additionally, the preferred stock will be automatically converted into Common Stock if the Company conducts an underwritten public offering of newly issued Common Stock with proceeds, net of underwriting discounts and commissions, exceeding $20 million and the price per share in such offering equals or exceeds $9.30. Common Stock In December 1997, the Company issued 4,000,000 shares of Common Stock in a public offering at a price of $4.50 per share. The proceeds of the offering were approximately $16.7 million before deducting offering costs of approximately $717,000. During 1995, 1996 and 1997, respectively, the Company issued 103,816 shares, 121,054 shares and 33,305 shares of Common Stock as payment of accrued dividends on Series A Preferred Stock. Additionally, during 1996, the Company induced the exercise of warrants by temporarily lowering exercise prices and issued 339,066 shares of Common Stock at a weighted average price of $3.10 upon exercise of certain warrants. During 1997, the Company issued 74,786 shares of Common Stock upon exercise of certain warrants and 2,027 shares of Common Stock upon the net exercise of warrants to acquire 15,000 shares of Common Stock. In 1992, the Company adopted a Restricted Stock Plan and issued 241,372 shares of Common Stock to employees, a director and a consultant of the Company for $.001 per share. The restricted stock vested over a four year period. Deferred compensation expense totaling $965,000 was expensed over the vesting period of the grants. The non-cash charge related to these stock grants was $239,000 for 1995 and $20,000 for 1996. F-10 50 Options The Company's Amended and Restated 1992 Stock Option Plan, as amended in 1997 (the "1992 Plan"), provides for the grant of options to purchase up to 1,500,000 shares of Common Stock. Granted options generally become exercisable over a four year period, 25 percent per year beginning on the first anniversary of the date of grant. To the extent not exercised, options generally expire on the tenth anniversary of the date of grant, except for employees who own more than 10 percent of all the voting shares of the Company, in which event the expiration date is the fifth anniversary of the date of grant. All options granted under the plan have exercise prices equal to the fair market value at the dates of grant. The Second Amended and Restated 1993 Non-Employee Director Stock Option Plan, as amended ("Director Plan") was adopted in 1993. A total of 750,000 shares of Common Stock are available for grant under the Director Plan. Upon amendment of the Director Plan in 1996, options to purchase 50,000 shares of Common Stock were granted to each then-current non-employee director of the Company at an exercise price equal to the fair market value of a share of Common Stock on the date of the Director Plan. Options to purchase 25,000 shares of Common Stock will be granted to newly elected directors at an exercise price equal to the fair market value of a share of Common Stock on such election date. The provisions of the Director Plan provide for an annual grant of an option to purchase 10,000 shares of Common Stock to each non-employee director. Options under the Director Plan generally vest one year after date of grant and expire after 10 years. A summary of stock option activity is as follows:
1992 Stock Option Plan Director Plan ---------------------- --------------- Weighted- Weighted- Avg. Exercise Avg. Exercise Options Price($) Options Price($) ---------- -------- ------- -------------- Balance at December 31, 1994 414,762 6.19 50,000 9.40 Granted ..................... 266,350 2.46 10,000 2.75 Exercised ................... (1,000) 3.00 -- -- Forfeited ................... (225,917) 8.97 -- -- ---------- --------- Balance at December 31, 1995 ... 454,195 2.63 60,000 8.29 ---------- --------- Granted ..................... 558,000 3.80 240,000 3.07 Exercised ................... (1,062) 2.74 (5,000) 2.88 Forfeited ................... (42,313) 3.18 -- -- Reissue ..................... -- -- (220,000) 4.14 ---------- --------- Balance at December 31, 1996 ... 968,820 3.28 75,000 4.11 ---------- --------- Granted ..................... 131,050 5.21 70,000 5.10 Exercised ................... (47,987) 2.68 -- -- Forfeited ................... (14,563) 3.75 -- -- ---------- --------- Balance at December 31, 1997 ... 1,037,320 3.54 145,000 4.59 ---------- --------- Exercisable at December 31, 1995 158,330 2.61 50,000 9.40 Exercisable at December 31, 1996 255,429 2.61 15,000 8.29 Exercisable at December 31, 1997 484,427 3.02 100,000 4.05
At December 31, 1997, 412,231 and 600,000 options were available for future grant under the 1992 Plan and the Director Plan, respectively. The exercise prices of options outstanding under the 1992 Plan and the Director Plan at December 31, 1997, range from $0.07 to $5.875 and $2.75 to $11.00, respectively. The weighted average contractual life of options outstanding at December 31, 1997, was 8.1 years for the 1992 Plan and 8.41 years for the Director Plan. In addition to the amounts set forth in the table above, during 1996 the Company granted options to purchase 220,000 shares of Common Stock to directors who resigned upon the closing of the sale of the Series B Preferred Stock in exchange for options previously granted under the Director Plan. These options have provisions identical to the options previously granted under the Director Plan, including exercise prices and vesting periods. The weighted average exercise price of the options granted was $4.14. The weighted average remaining contractual life of the grants was 7.8 years as of December 31, 1997. The Company expensed $150,000, which was the F-11 51 difference between the market price and the option price on the date of the grant, during 1996 related to this reissuance. During 1995, options to purchase 225,917 shares of Common Stock at exercise prices of $9.00 and $14.50 were canceled and reissued at substantially the same terms, but with an exercise price equal to the then current market price of $2.50. In October 1995, the Financial Accounting Standards Board issued SFAS No. 123 "Accounting for Stock-Based Compensation" which, if fully adopted, requires the Company to record stock-based compensation at fair value. The Company has adopted the disclosure requirements of SFAS No. 123 and has elected to record employee compensation expense in accordance with Accounting Principles Board Opinion (APB) No. 25. The Company accounts for its employee stock-based compensation plans under APB No. 25 and its related interpretations. Accordingly, deferred compensation expense is recorded for stock options based on the excess of the market value of the common stock on the date the options were granted over the aggregate exercise price of the options. This deferred compensation is amortized over the vesting period of each option. As the exercise price of options granted under the 1992 Plan and the Director Plan has been equal to or greater than the market price of the Company's stock on the date of grant, no compensation expense related to these plans has been recorded. Had compensation expense for its 1992 Plan and Director Plan been determined consistent with SFAS No. 123, the Company's net loss and loss per share would have been increased to the following pro forma amounts:
1995 1996 1997 ------------- ------------- --------------- Net Loss: As reported ....................... $ (3,905,404) $ (4,089,714) $ (6,138,635) Pro forma ......................... $ (3,940,041) $ (5,372,049) $ (7,058,879) Loss Per Share (Basic and Diluted): As reported ....................... $ (1.10) $ (1.14) $ (1.04) Pro forma ......................... $ (1.10) $ (1.42) $ (1.18)
Because the Statement 123 method of accounting has not been applied to options granted prior to January 1, 1995, the resulting pro forma compensation cost may not be representative of that to be expected in future years. Under the provisions of SFAS No. 123, the weighted average fair value of options granted in 1995, 1996 and 1997 was $1.88, $3.21 and $4.24 per share, respectively, under the 1992 Plan. The weighted average fair value of options granted in 1995, 1996 and 1997 was $2.21, $2.40 and $4.08 per share, respectively, under the Director Plan. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions used for grants in 1995, 1996 and 1997, respectively: a weighted average risk-free interest rate of approximately 6 percent for all years; no expected dividend yield during the expected life of the option; expected lives of 5 years for each grant and expected volatility between 97 and 113 percent. The stock options issued to retiring directors in 1996 had a weighted average fair value of $2.57. The fair values of such options are estimated on the date of grant using Black-Scholes option price model with the following assumptions used: a weighted average risk-free interest rate of 6 percent, expected lives of 3 to 5 years, expected volatility of 99 percent and no expected dividends. Warrants As of December 31, 1997, warrants to acquire a total of 3,163,478 shares of Common Stock were outstanding as set forth below. During 1996, the Company issued warrants to acquire 2,803,530 shares of Common Stock in conjunction with the sale of the Series B Preferred Stock (the "1996 Warrants"). The 1996 Warrants are exercisable at an exercise price of $4.13 per share. The warrants expire on the fifth anniversary of the date of grant, are callable if the average closing price of the Company's Common Stock for 30 trading days equals or exceeds three times the then-exercise price, and allow cashless exercise. The warrants also have provisions for adjustment of the exercise price and number of shares for below-exercise price issuance of securities. During 1997, warrants to acquire 74,786 Shares of Common Stock were exercised. As of December 31, 1997, warrants to acquire 2,728,744 Shares of Common Stock were outstanding. F-12 52 Additionally, the Company issued a warrant to acquire 354,734 shares of Common Stock to the placement agent for the Series B Preferred Stock ("Agent Warrant"). The Agent Warrant is exercisable at an exercise price of $4.50 per share. The warrant expires on the fifth anniversary of the date of grant and allows cashless exercise. The warrant also has provisions for adjustment of the exercise price and number of shares for below-exercise price issuance of securities. In connection with the sale of the Series A Preferred Stock, the Company issued warrants to acquire 264,500 shares of Common Stock at exercise prices of $3.26 per share during the first year and $3.54 per share during the second year. Additionally, the placement agent was issued a warrant to purchase 90,816 shares of Common Stock at $6.00 per share. A total of 339,066 warrants were exercised during 1996 through inducement of exercise by lowering the exercise price to $3.10 per share. The difference between the market price on the date of inducement and the induced exercise price has been deducted from net income to determine loss per Common share. A total of 15,000 warrants expired unexercised. As of December 31, 1997, additional warrants to acquire 80,000 shares of Common Stock were outstanding with exercise prices ranging from $2.50 to $11.05. Such warrants expire during periods ranging from February 26, 1998, to December 13, 2000. During 1997, 15,000 warrants were exercised on a net basis in exchange for 2,027 shares of Common Stock. In addition, 125,000 warrants expired unexercised. 7. EMPLOYEE BENEFIT PLANS: The Company maintains a retirement savings plan as described in Section 401(k) of the Internal Revenue Code of 1986, as amended. The Company may, at its discretion, contribute amounts not to exceed each employee's contribution. During January 1996, January 1997 and February 1998, the Company made total contributions of $5,292, $8,187 and $13,088 to the plan for a partial matching of employee contributions during 1995, 1996 and 1997, respectively. During 1996, the Company established an Employee Stock Purchase Plan to allow for the purchase of the Company's Common Stock on the open market using employee and any employer matching contributions. During 1996 and 1997, the Company contributed $1,328 and $7,631 to this plan, respectively. 8. FEDERAL INCOME TAXES: The Company has not made any income tax payments since inception. As of December 31, 1997, the Company has a net operating loss (NOL) carryforward for federal income tax purposes of approximately $32.1 million, subject to the limitations described below, expiring as follows:
YEAR EXPIRES ------------ 2001........................................................ $ 500,000 2002........................................................ 1,500,000 2003........................................................ 2,800,000 2004........................................................ 2,200,000 2005........................................................ 1,700,000 2006........................................................ 1,400,000 2007........................................................ 2,400,000 2008........................................................ 3,000,000 2009........................................................ 2,500,000 2010........................................................ 4,000,000 2011........................................................ 4,000,000 2012........................................................ 6,100,000 ------------- $ 32,100,000 =============
Additionally, the Company has approximately $395,000 of research and development tax credit carryforwards which will expire in varying amounts commencing in 2001. Federal tax laws provide for a limitation on the use of NOL and tax credit carryforwards following certain ownership changes that could limit LifeCell's ability to use its NOL and tax credit carryforwards. The sale of Common Stock in the public offering in December 1997 resulted in an ownership change for federal income tax purposes. The Company estimates that the amount of NOL carryforwards and the credits available to offset taxable income at December 31, 1997, is approximately $2.6 F-13 53 million per year on a cumulative basis. Accordingly, if LifeCell generates taxable income in any year in excess of its then cumulative limitation, the Company may be required to pay federal income taxes even though it has unexpired NOL carryforwards. For financial reporting purposes, a valuation allowance of $11,826,000 has been recorded as of December 31, 1997, to fully offset the deferred tax asset related to these carryforwards. The principal components of the deferred tax asset as of December 31, 1996 and 1997, assuming a 34% federal tax rate, are as follows:
1996 1997 ------------- ------------ Temporary differences: Deferred revenue................................................. $ 510,000 $ 530,000 Restricted stock compensation.................................... 154,000 -- Uniform capitalization of inventory costs........................ 37,000 45,000 Other items...................................................... (29,000) (58,000) ------------ ------------ Total temporary differences...................................... 672,000 517,000 Federal tax losses and credits not currently utilizable.......... 9,225,000 11,309,000 ------------ ------------ Total deferred tax assets........................................... 9,897,000 11,826,000 Less valuation allowance......................................... (9,897,000) 11,826,000) ------------ ------------ Net deferred tax asset.............................................. $ -- $ -- ============ ============
The net increase in the deferred tax valuation allowance for 1996 and 1997 was $1,440,000, and $1,929,000, respectively. Other than the net operating loss and tax credit carryforwards, there is no significant difference between the statutory federal income tax rate and the Company's effective tax rate during 1995, 1996 and 1997. 9. COLLABORATIONS AND CORPORATE ALLIANCES: Medtronic Collaboration During March 1994, the Company entered into a license and development agreement with Medtronic, Inc. ("Medtronic") to develop jointly the Company's heart valve products. Pursuant to the agreement, Medtronic paid the Company an initial $1.5 million license fee. Medtronic funds in part the cost of research and development under a mutually agreed upon budget, has the exclusive right to market any resulting commercial products and must pay the Company royalties on sales of products covered by the agreement. LifeCell's research and development funding by Medtronic in 1995, 1996 and 1997 were $825,221, $546,460 and $217,854. Royalties payable to the Company under the agreement are limited to an aggregate maximum of $25.0 million. Medtronic may terminate the agreement at any time if in its sole business judgment it deems the development and commercialization of products thereunder not to be in its best interests or otherwise to be imprudent. In such an event, and if the agreement is terminated under certain other circumstances, the $1.5 million license fee paid by Medtronic will be converted into shares of Common Stock, subject to certain limitations, at the market price at the time of conversion, and any unconverted portion of the fee will be refunded to Medtronic. Accordingly, such $1.5 million license fee has been recorded as a deferred credit in the accompanying financial statement. Other Product Sales Arrangements The Company has negotiated other distribution or sales collaboration arrangements with various parties with exclusive regional or international territories under each agreement. The agreements generally provide that the distributor must meet certain performance measures or the agreement may be terminated by the Company. 10. COMMITMENTS AND CONTINGENCIES: Litigation The Company is subject to numerous risks and uncertainties and from time to time may be subject to various claims in the ordinary course of its operations. The Company maintains insurance coverage for events and in amounts that it deems appropriate. There can be no assurance that the level of insurance maintained will be sufficient to cover any claims incurred by the Company or that the type of claims will be covered by the terms of insurance coverage. F-14 54 In November 1997, Integra (Artificial Skin) Corporation ("Integra"), a subsidiary of Integra LifeSciences Corporation, and the Massachusetts Institute of Technology ("MIT") filed a lawsuit in the United States District Court for the District of Massachusetts, alleging that the Company infringes two patents licensed by MIT to Integra (the "Integra Patents"). The lawsuit seeks injunctive relief, an accounting of revenues, treble and other monetary damages and attorneys' fees. LifeCell filed a response to the complaint denying the infringement claims and asserting certain affirmative defenses and counterclaims. The Company has received an opinion from its patent counsel to the effect that the current uses of AlloDerm do not infringe the Integra Patents. This opinion represents only the reasoned professional judgment of the Company's patent counsel and is not binding on any court or third party. Patent litigation involves complex legal and factual questions. As a result, the outcome of such litigation is inherently unpredictable, and there can be no assurance that the result of this proceeding will be favorable to the Company or that it will not have a material adverse effect on the Company's business, operating results or financial condition. If it is determined that the Company is infringing the Integra Patents, the court could issue an injunction prohibiting the Company from making, using or selling its AlloDerm product for some or all of its intended uses. Such injunction could also extend to certain of the Company's other potential products under development. In addition, the court could assess significant damages and attorneys' fees against the Company, which would have a material adverse effect on the Company's business, operating results and financial condition and otherwise affect the ability of the Company to continue as a viable enterprise. In addition, an adverse determination in this proceeding could require the Company to seek licenses from Integra, which may not be available on reasonable terms, if at all. Regardless of the outcome, defending such claims could involve significant costs and diversion of management resources, which could have a material adverse effect on the Company's business, operating results or financial condition. During 1997, the Company recorded an expense of $340,000 for the estimated litigation costs expected to be incurred in connection with this matter during 1998. In December 1997, LifeCell filed a lawsuit in Texas state court against Integra LifeSciences Corporation and MIT alleging that they tortiously interfered with certain of LifeCell's business relationships, including relationships with investors and potential investors in LifeCell's recent public offering. The lawsuit also alleges anticompetitive acts and business disparagement. LifeCell is seeking injunctive relief and enhanced and punitive damages. Such a suit can be costly to litigate and there is no assurance that it will have a favorable outcome to the Company or that any damages will be recovered. External Funding for Research Certain of the Company's research programs have been funded by Small Business Innovation Research (SBIR) grants and other direct federal government funding contracts. The grants and contracts generally obligate the Company to perform specified research activities in return for such funding, and the utilization of funds under the grants is subject to audit by the appropriate governmental agencies. At December 31, 1997, the Company had received $59,519 of deferred revenue, which is an advance payment from a corporate alliance, for research to be conducted during 1998. License Agreements The Company has entered into several license agreements, both exclusive and nonexclusive in conjunction with its business. The Company is required to pay royalties on net sales of products encompassing the licensed technologies. For the years ended December 31, 1996 and 1997, $18,630 and $141,539 of expenses were incurred under these agreements. Leases The Company leases approximately 25,000 square feet for office and laboratory space and has various other operating leases. The future minimum lease payments under noncancelable lease terms in excess of one year as of December 31, 1997, were as follows:
1998................................................................. $ 298,992 1999................................................................. 250,722 2000................................................................. 241,068 2001................................................................. 27,641 2002................................................................. -- ------------ Total........................................................... $ 818,423 ============
F-15 55 11. TRANSACTIONS WITH RELATED PARTIES: The Company leases office space from an entity which was an affiliate of a stockholder of the Company prior to 1998. The Company paid rent expense of approximately, $129,000, $142,000 and $223,000 during 1995, 1996, and 1997, respectively, related to this lease. The Company paid consulting fees and expenses to an affiliate of a person who was a director of the Company until November 1996. Such amounts totaled approximately $91,000 and $80,000 during the years ended December 31, 1995 and 1996, respectively, pursuant to a consultant agreement. As of December 31, 1997, the Company had notes receivable totaling $95,060 from participants, two of whom are directors and officers of the Company, in a previous deferred compensation plan. Such notes represent loans of federal income tax amounts payable by the individuals as a result of grants under the plan. 12. QUARTERLY FINANCIAL DATA (UNAUDITED): The following table presents summary unaudited financial data for the years ended December 31, 1996 and 1997. The Company believes that this information reflects all adjustments, consisting of only normal recurring items, considered necessary for a fair presentation of the quarterly financial information presented. The operating results for any quarterly period are not necessarily indicative of the results that may be expected for future periods.
First Second Third Fourth Quarter Quarter Quarter Quarter ------- ------- ------- ------- (In thousands except per share amounts) 1996 Product Sales ............................ $ 421 $ 429 $ 561 $ 602 Total Revenues ........................... $ 576 $ 678 $ 816 $ 876 Gross Margin on Product Sales ............ $ 149 $ 157 $ 205 $ 220 Net Loss ................................. $ (949) $ (909) $(1,023) $(1,209) Loss Per Common Share--Basic and Diluted.. $ (0.25) $ (0.24) $ (0.33) $ (0.32) 1997 Product Sales ............................ $ 821 $ 1,007 $ 1,410 $ 1,667 Total Revenues ........................... $ 1,111 $ 1,273 $ 1,634 $ 1,962 Gross Margin on Product Sales ............ $ 331 $ 487 $ 715 $ 831 Net Loss ................................. $(1,650) $(1,573) $(1,393) $(1,523) Loss Per Common Share--Basic and Diluted.. $ (0.41) $ (0.25) $ (0.23) $ (0.20)
F-16 56
INDEX TO EXHIBITS EXHIBIT NUMBER DESCRIPTION ------ ----------- 3.1* Restated Certificate of Incorporation, as amended. 3.2 Amended and Restated By-laws (incorporated by reference to Exhibit 3.2 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 1996) 10.1+ LifeCell Corporation Amended and Restated 1992 Stock Option Plan, as amended (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the period ended June 30, 1997, filed with the Commission on August 12, 1997). 10.2+ LifeCell Corporation Second Amended and Restated 1993 Non-Employee Director Stock Option Plan, as amended (incorporated by reference to Exhibit 10.4 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996, filed with the Commission on March 31, 1997). 10.3 Form of Confidentiality/Non-Compete Agreement (incorporated by reference to Exhibit 10.28 to the Company's Registration Statement on Form S-1, Registration No. 33-44969, filed with the Commission on January 9, 1992). 10.4 Exclusive License Agreement dated June 6, 1986, between the Registrant and The Board of Regents of The University of Texas System (incorporated by reference to Exhibit 10.29 to the Company's Registration Statement on Form S-1, Registration No. 33-44969, filed with the Commission on January 9, 1992). 10.5+ Amended and Restated Registration Rights Agreement dated February 26, 1992, by and between the Registration and the stockholders named therein (incorporated by reference to Exhibit 10.40 to Amendment No. 3 to the Company's Registration Statement on Form S-1, Registration No. 33-44969, filed with the Commission on February 27, 1992). 10.6 Underwriter's Warrant Agreement dated March 6, 1992, between the Registrant and Robert Todd Financial Corporation, and First Amendment to Underwriter's Warrant Agreement dated January 26, 1993, between the Registrant and Robert Todd Financial Corporation (incorporated by reference to Exhibit 10.18 to the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 1992). 10.7 Lease Agreement dated December 10, 1986, between the Registrant and The Woodlands Corporation, Modification and Ratification of Lease Agreement dated April 11, 1988, between the Registration and The Woodlands Corporation Modification and Ratification of Lease dated August 1, 1992, between the Company and The Woodlands Corporation and Modification, Extension and Ratification of Lease dated March 5, 1993, between the Registrant and The Woodlands Corporation, and Modification and Ratification of Lease Agreement dated December 21, 1995, between the Company and The Woodlands Office Equities -- '95 Limited (incorporated by reference to Exhibit 10.1 to the Company's Quarterly Report on Form 10-Q for the period ended March 31, 1996). 10.8 Lease Agreement dated September 1, 1988, between the Registrant and The Woodlands Corporation, and Modification of Lease Agreement dated March 5, 1993, between the Registrant and The Woodlands Corporation (incorporated by reference to Exhibit 10.22 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1992). 10.9 Stock Purchase Warrant dated January 26, 1993, issued to Strategem of Alabama, Inc. (incorporated by reference to Exhibit 10.25 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1992). 10.10 License and Development Agreement dated March 3, 1994, between the Registrant and Medtronic, Inc. (incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K dated March 3, 1994). 10.11 Investment Agreement dated March 3, 1994, between the Registrant and Medtronic, Inc. (incorporated by reference to Exhibit 10.2 to Company's Current Report on Form 8-K dated March 3, 1994). 10.12 Lease Agreement between LifeCell Corporation and Unichem, dated August 1, 1994 (incorporated by reference to Exhibit 10.3 to the Company's Quarterly Report on Form 10-Q for the period ended September 30, 1994). 10.13 Securities Purchase Agreement dated November 18, 1996, between LifeCell Corporation and the Investors named therein (incorporated by reference to Exhibit 10.15 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.14 Voting Agreement dated November 18, 1996, among LifeCell Corporation and certain stockholders named therein (incorporated by reference to Exhibit 10.16 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.15 Registration Rights Agreement dated November 18, 1996, between LifeCell Corporation and certain stockholders named therein (incorporated by reference to Exhibit 10.17 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.16 Form of Stock Purchase Warrant dated November 18, 1996, issued to each of the warrant holders named on Schedule 10.18 attached thereto (incorporated by reference to Exhibit 10.18 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996). 10.17 Stock Purchase Warrant dated November 18, 1996, issued to Gruntal & Co., Incorporated (incorporated by reference to Exhibit 10.19 to Amendment No. 1 to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 1996 on Form 10-K/A). 10.18+ Agreement dated July 1, 1997, between LifeCell Corporation and Paul M. Frison.(incorporated by reference to Exhibit 10.20 to the Company's Registration Statement No. 333-37123 on Form S-2 filed with the Commission on October 3, 1997). 10.19+ Agreement dated July 1, 1997, between LifeCell Corporation and Stephen A. Livesey. (incorporated by reference to Exhibit 10.20 to the Company's Registration Statement No. 333-37123 on Form S-2 filed with the Commission on October 3, 1997). 23.1* Consent of Arthur Andersen LLP. 27.1* Financial data schedule.
EX-3.1 2 RESTATED CERTIFICATE OF INCORPORATION 1 EXHIBIT 3.1 RESTATED CERTIFICATE OF INCORPORATION OF LIFECELL CORPORATION (Originally incorporated under the name "Successor LifeCell Corporation" on January 6, 1992) First: The name of the Corporation is LifeCell Corporation. Second: The registered office of the Corporation in the State of Delaware is located at Corporation Trust Center, 1209 Orange Street in the City of Wilmington, County of New Castle. The name of its registered agent at such address is The Corporation Trust Company. Third: The purpose of the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware. Fourth: The total number of shares of capital stock that the Corporation shall have authority to issue is 14,500,000, of which 2,000,000 shares of the par value of $.001 per share shall be a class designated Preferred Stock ("Preferred Stock"), and 12,500,000 shares of the par value of $.001 per share shall be a class designated Common Stock ("Common Stock"). The voting powers, designations, preferences and relative, participating, optional or other special rights and the qualifications, limitations or restrictions thereof, of the Preferred Stock and Common Stock, and the authority with respect thereto expressly granted to the Board of Directors of the Corporation, are as follows: A. Common Stock. 1. Voting Rights. The holders of shares of Common Stock shall have the following voting rights: (a) Each share of Common Stock shall entitle the holder thereof to one vote on all matters submitted to a vote of the stockholders of the Corporation. (b) Except as otherwise required by law or the provisions of this Restated Certificate of Incorporation, the holders of shares of Common Stock shall not be entitled to vote separately as a class on any matter submitted to a vote of the stockholders of the Corporation. 2. Liquidation. Subject to the provisions of this Restated Certificate of Incorporation, in the event of any liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or involuntary, after payment or provision for payment of any preferential amount due the holders of shares of any other class or series of stock, the holders of shares of Common Stock shall be entitled to receive 2 ratably, based on the number of shares of Common Stock held by such holders, any assets of the Corporation available for distribution to holders of Common Stock. 3. Dividends. Subject to the provisions of this Restated Certificate of Incorporation, the Board of Directors, in its discretion, out of funds legally available for the payment of dividends and at such times and in such manner as determined by the Board of Directors, may declare and pay dividends on the outstanding shares of Common Stock of the Corporation. 4. Reacquired Shares. Any shares of Common Stock purchased or otherwise acquired by the Corporation in any manner whatsoever that have been retired shall upon their retirement become authorized but unissued shares of Common Stock. B. Preferred Stock. 1. Additional Series of Preferred Stock. The Board of Directors is hereby expressly vested with the authority to adopt a resolution or resolutions providing for the issue of authorized but unissued shares of Preferred Stock, which shares may be issued from time to time in one or more series and in such amounts as may be determined by the Board of Directors in such resolution or resolutions. The voting powers, designations, preferences and relative, participating, optional or other special rights, if any, of each such series of Preferred Stock and the qualifications, limitations or restrictions, if any, thereof (collectively the "Series Terms"), shall be such as are stated and expressed in a resolution or resolutions providing for the creation or revision of such Series Terms adopted by the Board of Directors or, to the extent permitted by law, a committee of the Board of Directors to which such responsibility is specifically and lawfully delegated. 2. Series A Preferred Stock. The voting powers, designations, preferences and relative, participating, optional or other special rights, and the qualifications, limitations or restrictions thereof, of one series of Preferred Stock, the Series A Preferred Stock, designated on November 9, 1994, are as follows: (a) Designation. The designation of the series shall be "Series A Preferred Stock" (the "Series A Preferred Stock"). (b) Number. The number of shares constituting the Series A Preferred Stock shall be 300,000. (c) Voting Rights. The holders of shares of Series A Preferred Stock shall have the following voting rights: (i) Except as required by law or Section B.2.(c)(ii) of this Article Fourth, the holders of shares of Series A Preferred Stock shall not have any right or power to vote on any question or in any proceeding or to be represented at or to receive -2- 3 notice of any meeting or consent of stockholders. On any matters on which the holders of the Series A Preferred Stock shall be entitled to vote, each share of Series A Preferred Stock shall entitle the holder thereof to one vote multiplied by the number of shares of Common Stock into which such share of Series A Preferred Stock is convertible on the record date for such vote. (ii) Without the vote or consent of the holders of at least a majority of the shares of Series A Preferred Stock then outstanding, the Corporation may not (A) authorize, create or issue, or increase the authorized number of shares of, any class or series of capital stock ranking prior to or on a parity with the Series A Preferred Stock either as to dividends or liquidation, (B) authorize, create or issue any class or series of common stock of the Corporation other than the Common Stock, (C) authorize any reclassification of the Series A Preferred Stock, (D) authorize, create or issue any securities convertible into capital stock prohibited by Section B.2.(c)(ii)(A) or (B) of this Article Fourth, or (E) amend Section B.2 of this Article Fourth. (d) Liquidation. (i) Preference. Subject to the rights of the holders of any other series of Preferred Stock ranking senior to or on a parity with the Series A Preferred Stock with respect to liquidation and any other class or series of capital stock of the Corporation ranking senior to or on a parity with the Series A Preferred Stock with respect to liquidation, in the event of any liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or involuntary, the holders of record of the issued and outstanding shares of Series A Preferred Stock shall be entitled to receive, out of the assets of the Corporation available for distribution to the holders of shares of Series A Preferred Stock, prior and in preference to any distribution of any of the assets of the Corporation to the holders of Common Stock or and any other series of Preferred Stock ranking junior to the Series A Preferred Stock with respect to liquidation and any other class or series of capital stock of the Corporation ranking junior to the Series A Preferred Stock with respect to liquidation, an amount in cash per share equal to $20.00, plus an amount equal to all dividends accrued and unpaid on each such share (whether or not declared) up to the date fixed for distribution. If, upon such liquidation, dissolution or winding up of the affairs of the Corporation, the assets of the Corporation distributable among the holders of Series A Preferred Stock and any other series of Preferred Stock ranking on a parity therewith in respect thereto or any class or series of capital stock of the Corporation ranking on a parity therewith in respect thereto shall be insufficient to permit the payment in full to all such holders of shares of the preferential amounts payable to them, then the entire assets of the Corporation available for distribution to such holders of shares shall be distributed ratably among such holders in proportion to the respective amounts that would be payable per share if such assets were sufficient to permit payment in full. After payment of the full amount to which they are entitled upon liquidation pursuant to this Section B.2.(d)(i), the holders of shares of Series A Preferred Stock will not be entitled to any further participation in any distribution of assets by the Corporation. Neither a consolidation or merger of the Corporation with another corporation or other entity nor a sale, transfer, lease or exchange of all or part of the Corporation's assets will be -3- 4 considered a liquidation, dissolution or winding up of the affairs of the Corporation for purposes of this Section B.2.(d)(i). (ii) Adjustments. The liquidation preference provided for herein with respect to the Series A Preferred Stock shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Series A Preferred Stock. (e) Conversion Rights. (i) Optional Conversion. Subject to and upon compliance with the provisions of this Section B.2.(e) (and Section B.2.(g) with respect to conversion after notice of redemption), the holder of any shares of Series A Preferred Stock shall have the right at such holder's option, at any time or from time to time, and without the payment of any additional consideration therefor, to convert any of such shares of Series A Preferred Stock into fully paid and nonassessable shares of Common Stock at the Conversion Price (as defined in Section B.2.(e)(iii) below) in effect on any Conversion Date (as defined in Section B.2.(e)(iv) below) upon the terms hereinafter set forth. (ii) Automatic Conversion. Each outstanding share of Series A Preferred Stock shall automatically be converted, without any further act of the Corporation or its stockholders, at the Conversion Price then in effect, into fully paid and nonassessable shares of Common Stock on November 9, 1997. (iii) Number of Conversion Shares. Each share of Series A Preferred Stock shall be convertible pursuant to Sections B.2.(e)(i) and B.2.(e)(ii) into a number of shares of Common Stock determined by dividing (x) $20.00 by (y) the Conversion Price in effect on any Conversion Date. For the purposes of this Section B.2.(e), the term "Conversion Price" shall initially mean $2.99. (iv) Mechanics of Conversion. The holder of any shares of Series A Preferred Stock may exercise the conversion right specified in Section B.2.(e)(i) by surrendering to the Corporation or any transfer agent of the Corporation the certificate or certificates for the shares to be converted, accompanied by written notice specifying the number of shares to be converted. Upon the occurrence of automatic conversion pursuant to Section B.2.(e)(ii), the outstanding shares of Series A Preferred Stock shall be converted automatically without any further action by the holders of such shares and whether or not the certificates representing such shares are surrendered to the Corporation or its transfer agent; provided that the Corporation shall not be obligated to issue to any holder certificates evidencing the shares of Common Stock issuable upon such conversion unless certificates evidencing such shares of Series A Preferred Stock are delivered either to the Corporation or any transfer agent of the Corporation. Conversion shall be deemed to have been effected on the date when delivery of notice of an election to convert and of certificates for shares being converted is made or on the date specified in Section B.2.(e)(ii), as the case may be, and such date is referred to herein as the "Conversion Date". Subject to the provisions of -4- 5 Section B.2.(e)(vi)(C), as promptly as practicable thereafter (and after surrender of the certificate or certificates representing shares of Series A Preferred Stock to the Corporation or any transfer agent of the Corporation in the case of conversion pursuant to Section B.2.(e)(ii)) the Corporation shall issue and deliver to or upon the written order of such holder a certificate or certificates for the number of full shares of Common Stock to which such holder is entitled and a check or cash with respect to any fractional interest in a share of Common Stock as provided in Section B.2.(e)(v). Subject to the provisions of Section B.2.(e)(vi)(C), the person in whose name the certificate or certificates for Common Stock are to be issued shall be deemed to have become a holder of record of such Common Stock on the applicable Conversion Date. Upon conversion of only a portion of the number of shares covered by a certificate representing shares of Series A Preferred Stock surrendered for conversion (in the case of conversion pursuant to Section B.2.(e)(i)), the Corporation shall issue and deliver to or upon the written order of the holder of the certificate so surrendered for conversion, at the expense of the Corporation, a new certificate covering the number of shares of Series A Preferred Stock representing the unconverted portion of the certificate so surrendered. (v) Fractional Shares. No fractional shares of Common Stock or scrip shall be issued upon conversion of shares of Series A Preferred Stock. If more than one share of Series A Preferred Stock shall be surrendered for conversion at any one time by the same holder or shall be held by the same holder at the time of any automatic conversion, the number of full shares of Common Stock issuable upon conversion thereof shall be computed on the basis of the aggregate number of shares so surrendered or held, as the case may be. Instead of any fractional shares of Common Stock which would otherwise be issuable upon conversion of any shares of Series A Preferred Stock, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the then Current Market Price (as defined in Section B.2.(e)(vii) below), rounded to the nearest cent ($.01). (vi) Common Stock Conversion Price Adjustments. The Conversion Price shall be subject to adjustment from time to time as follows: (A) Stock Dividends, Subdivisions, Reclassifications or Combinations. If the Corporation shall (x) declare a dividend or make a distribution on its Common Stock in shares of its Common Stock, (y) subdivide or reclassify the outstanding shares of Common Stock into a greater number of shares of Common Stock or (z) combine or reclassify the outstanding shares of Common Stock into a smaller number of shares of Common Stock, the Conversion Price in effect at the time of the record date for such dividend or distribution or the effective date of such subdivision, combination or reclassification shall be adjusted to that price determined by multiplying the Conversion Price in effect by a fraction (x) the numerator of which shall be the total number of issued and outstanding shares of Common Stock immediately prior to such dividend, distribution, subdivision, combination or reclassification and (y) the denominator of which shall be the total number of issued and outstanding shares of Common Stock immediately after such dividend, distribution, subdivision, combination -5- 6 or reclassification. Successive adjustments in the Conversion Price shall be made whenever any event specified above shall occur. (B) Rounding of Calculations; Minimum Adjustment. All calculations under this Section B.2.(e)(vi) shall be made to the nearest cent ($.01) or to the nearest one hundredth (1/100th) of a share, as the case may be. Any provision of this Section B.2.(e) to the contrary notwithstanding, no adjustment in the Conversion Price shall be made if the amount of such adjustment would be less than 1% of the then current Conversion Price until the end of one year after such adjustment would otherwise have been required; but any such amount shall be carried forward and an adjustment with respect thereto shall be made at the time of and together with any subsequent adjustment which, together with such amount and any other amount or amounts so carried forward, shall aggregate 1% of the then current Conversion Price or more, provided that if the events giving rise to such adjustments occur within three months of each other, then such adjustments shall be calculated as if these events giving rise to them had occurred simultaneously on the date of the first such event. (C) Timing of Issuance of Additional Common Stock Upon Certain Adjustments. In any case in which the provisions of this Section B.2.(e)(vi) shall require that an adjustment shall become effective immediately after a record date for an event, the Corporation may defer until the occurrence of such event (x) issuing to the holder of any share of Series A Preferred Stock converted after such record date and before the occurrence of such event the additional shares of Common Stock issuable upon such conversion by reason of the adjustment required by such event over and above the shares of Common Stock issuable upon such conversion before giving effect to such adjustment and (y) paying to such holder any amount of cash in lieu of a fractional share of Common Stock pursuant to Section B.2.(e)(v); provided that the Corporation upon request shall deliver to such holder a due bill or other appropriate instrument evidencing such holder's right to receive such additional shares, and such cash, upon the occurrence of the event requiring such adjustment. (vii) Current Market Price. The "Current Market Price" at any date shall mean, in the event the Common Stock is publicly traded, the average of the daily closing prices per share of such equity security for the 20 consecutive trading days ending on the trading day immediately before such date (as adjusted for any stock dividend, split, combination or reclassification that took effect during such 20 trading day period). The closing price for each day shall be the last reported sale price regular way or, in case no such reported sale takes place on such day, the average of the last closing bid prices regular way, in either case on the principal national securities exchange on which such equity security is listed or admitted to trading, or if not listed or admitted to trading on any national securities exchange, the closing bid price for such day reported by NASDAQ, if such equity security is traded over-the-counter and quoted in the National Market System, or if such equity security is so traded, but not so quoted, the average of the closing bid prices of such equity security as reported by NASDAQ or any comparable system or, if such equity security is not listed on NASDAQ or any comparable system, the average of the closing bid prices as furnished by two members of the National Association of Securities Dealers, Inc., selected in good faith from time to time by the Board of Directors of the Corporation for that purpose. If -6- 7 such equity security is not traded in such manner that the quotations referred to above are available for the period required hereunder, Current Market Price per share of such equity security shall be deemed to be the fair value as determined in good faith by the Board of Directors of the Corporation, irrespective of any accounting treatment. (viii) Statement Regarding Adjustments. Whenever the Conversion Price shall be adjusted as provided in Section B.2.(e)(vi), the Corporation shall forthwith file, at the office of any transfer agent for the Series A Preferred Stock and at the principal office of the Corporation, a statement showing in detail the method of calculation of such adjustment, the facts requiring such adjustment and the Conversion Price that shall be in effect after such adjustment, and the Corporation shall also cause a copy of such statement to be sent by mail, first class postage prepaid, to each holder of shares of Series A Preferred Stock at its address appearing on the Corporation's records. Each such statement shall be signed by the Corporation's chief financial officer. Where appropriate, such copy may be given in advance and may be included as part of a notice required to be mailed under the provisions of Section B.2.(e)(ix). (ix) Notice to Holders. In the event the Corporation shall propose to take any action of the type described in Section B.2.(e)(vi)(A) or B.2.(e)(x), the Corporation shall give notice to each holder of shares of Series A Preferred Stock in the manner set forth in Section B.2.(e)(viii), which notice shall specify the record date, if any, with respect to any such action and the approximate date on which such action is to take place. Such notice shall also set forth such facts with respect thereto as shall be reasonably necessary to indicate the effect of such action (to the extent such effect may be known at the date of such notice) on the Conversion Price and the number, kind or class of shares or other securities or property which shall be deliverable upon conversion of shares of Series A Preferred Stock. In the case of any action which would require the fixing of a record date, such notice shall be given at least ten calendar days prior to the date so fixed, and in the case of all other action, such notice shall be given at least 15 calendar days prior to the taking of such proposed action. Failure to give such notice, or any defect therein, shall not affect the legality or validity of any such action. (x) Mergers, etc. In the event the Corporation shall be a party to any transaction (including, without limitation, a merger, consolidation, sale, lease or transfer of all or substantially all of its assets, reclassification of the Common Stock or reorganization of the Company) as a result of which shares of Common Stock shall be converted into the right to receive stock, securities or other property (including cash or any combination thereof), each share of Series A Preferred Stock shall thereafter be convertible into the kind and amount of shares of stock and other securities and property receivable (including cash) upon the consummation of such transaction by a holder of that number of shares of Common Stock, or fraction thereof, into which one share of Series A Preferred Stock was convertible immediately prior to such transaction. (xi) Treasury Stock. For the purposes of this Section B.2.(e), the sale or other disposition of any shares of Common Stock theretofore held in the Corporation's treasury shall be deemed to be an issuance thereof. -7- 8 (xii) Costs. The Corporation shall pay all documentary, stamp, transfer or other transactional taxes attributable to the issuance or delivery of shares of Common Stock upon conversion of any shares of Series A Preferred Stock; provided that the Corporation shall not be required to pay any taxes which may be payable in respect of any transfer involved in the issuance or delivery of any certificate for such shares in a name other than that of the holder of the shares of Series A Preferred Stock in respect of which such shares are being issued. (xiii) Dividends Upon Conversion. In connection with any conversion of shares of Series A Preferred Stock, the Corporation shall pay accrued and unpaid dividends thereon in accordance with the provisions of Section B.2.(f)(iv). (f) Dividends. (i) General. (A) Subject to the rights of the holders of any other series of Preferred Stock ranking senior to or on a parity with the Series A Preferred Stock with respect to dividends and any other class or series of capital stock of the Corporation ranking senior to or on a parity with the Series A Preferred Stock with respect to dividends, other than the Common Stock, the holders of the Series A Preferred Stock shall be entitled to receive, when and as declared by the Board of Directors, cumulative dividends per share of Series A Preferred Stock at the rate per annum of (1) $1.20, during the period commencing on the date of original issuance of any shares of Series A Preferred Stock and ending on November 9, 1995, (2) $1.60, during the period commencing on November 10, 1995, and ending on November 9, 1996, and (3) $2.00, during the period commencing on November 10, 1996, and ending on November 9, 1997. (B) Dividends on the Series A Preferred Stock will accrue on each February 9, May 9, August 9 and November 9, occurring after the date of original issuance (each such date being referred to herein as an "Accrual Date" and the three-month period or portion thereof, as the case may be, ending on an Accrual Date being referred to herein as an "Accrual Period"). Dividends will accrue from the date of original issuance. Dividends will be paid (when and as declared by the Board of Directors of the Corporation) annually, in the arrears, on November 9, 1995, November 9, 1996, and November 9, 1997. Each such dividend shall be paid to the holders of record of shares of the Series A Preferred Stock as they appear on the stock register of the Corporation on such record date not exceeding 45 nor less than ten calendar days preceding the payment date thereof, as shall be fixed by the Board of Directors of the Corporation. Dividends on account of arrears for any past dividend periods may be declared and paid at any time, without reference to any regular dividend payment date, to holders of record on such date, not exceeding 45 nor less than ten calendar days preceding the payment date thereof, as may be fixed by the Board of Directors of the Corporation. Holders of shares of Series A Preferred Stock at the close of business on a dividend payment record date will be entitled to receive the dividend payable with respect to such shares on the corresponding dividend payment date notwithstanding the conversion thereof or the Corporation's default on -8- 9 payment of the dividend due on such dividend payment date. However, for shares of Series A Preferred Stock surrendered for conversion during the period from the close of business on any dividend payment record date to the opening of business on the corresponding dividend payment date, the Corporation shall only be required to pay the dividend to the holder of such shares on the dividend payment record date. Except as so provided above and in Section B.2.(f)(iv) below, no payment or adjustment will be made on account of accrued or unpaid dividends upon conversion of shares of Series A Preferred Stock. Holders of shares of Series A Preferred Stock called for redemption on a redemption date falling between a dividend payment record date and the dividend payment date shall, in lieu of receiving such dividend on the dividend payment date, receive such dividend payment on the redemption payment date (unless such holders convert such shares in accordance with this Section B.2 of this Article Fourth). (C) The Corporation shall pay the dividends on the Series A Preferred Stock described in Section B.2.(f)(i)(A), at the Corporation's option and in its sole discretion, out of funds legally available therefor (1) in cash, (2) in shares of Common Stock, such that the number of shares of Common Stock to be distributed as a dividend with respect to the portion of the dividend attributable to each Accrual Period shall be equal to the number obtained by dividing the dollar amount of the portion of the dividend attributable to such Accrual Period by the greater of (I) the Current Market Price of the Common Stock on the tenth trading day immediately preceding the applicable Accrual Date and (II) $2.00 (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Common Stock), or (III) in any combination of cash and shares of Common Stock that the Corporation may determine in its sole discretion, with the number of shares of Common Stock to be distributed in connection therewith to be calculated on the basis set forth in Section B.2.(f)(i)(C)(2). (D) No fractional shares of Common Stock or scrip shall be issued upon payment of any dividends in shares of Common Stock. If more than one share of Series A Preferred Stock shall be held by the same holder at the time of any dividend payment date, the number of full shares of Common Stock issuable upon payment of such dividends shall be computed on the basis of the aggregate dividend amount that the Corporation has determined to pay in Common Stock shares. Instead of any fractional shares of Common Stock which would otherwise be issuable upon payment of such dividends, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the then Current Market Price, rounded to the nearest cent ($.01). (E) Notwithstanding the dividend rate otherwise applicable pursuant to Section B.2.(f)(i)(C) and notwithstanding any other provision of this Section B.2 of this Article Fourth to the contrary, in the event the Corporation pays any dividends in shares of Common Stock and pursuant to the provisions of Section B.2.(f)(i)(C) the Current Market Price used in the calculation of the number of shares payable in respect of such dividends in respect of any Accrual Period is less than $2.00, as shall be equitably adjusted to reflect any stock dividend, stock distribution, -9- 10 stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Common Stock (and, therefore, pursuant to and for purposes of Section B.2.(f)(i)(C), deemed to be equal to $2.00, as so adjusted), payment of any such dividends in shares of Common Stock calculated pursuant thereto shall constitute payment in full of any such dividends. (ii) Allocation of Dividends. Dividends on the Series A Preferred Stock, if paid, or if declared and set apart for payment, must be paid or declared and set apart for payment on all outstanding shares of Series A Preferred Stock contemporaneously. In the event dividends on the Series A Preferred Stock and any other series of Preferred Stock ranking on a parity therewith in respect thereto or any other class or series of capital stock of the Corporation ranking on a parity therewith in respect thereto are declared and paid in an amount less than all accumulated and current dividends on all of such shares, the total amount declared and paid shall be allocated among all of such shares so that the per share dividend to be declared and paid on each share is the same percentage of the sum of the accumulated dividends for each such share. In the event dividends are declared and paid on the Series A Preferred Stock in a combination of cash and shares of Common Stock, the percentage of the dividend paid in cash and the percentage of the dividend paid in stock must be the same for each share of Series A Preferred Stock. (iii) Dividend Priorities. The Corporation shall not declare or pay any distributions to the holders of the Common Stock or any other class or series of capital stock ranking junior to the Series A Preferred Stock in respect of dividends during any period of time in which any shares of Series A Preferred Stock are outstanding or in which any dividends payable on any shares of Series A Preferred Stock have not been declared and paid in full. In this Section B.2.(f)(iii), "distribution" means the transfer of cash or property without consideration, whether by way of dividend or otherwise (except a dividend solely in shares of Common Stock), or the purchase or redemption by the Corporation of shares of Common Stock or any other shares of capital stock of the Corporation ranking junior to the Series A Preferred Stock in respect of dividends for cash or property, but does not include the repurchase by the Corporation of shares from an officer, director, employee or consultant of the Corporation. (iv) Dividends on Conversion or Redemption. (A) Immediately prior to the conversion of any shares of Series A Preferred Stock into Common Stock or the redemption of any shares of Series A Preferred Stock, all accrued and unpaid dividends payable pursuant to Section B.2.(f) (whether or not declared) on such shares so converted or redeemed, as the case may be, (prorated until the date of conversion or redemption, as the case may be, in respect of the Accrual Period in which such date occurs) shall be payable, at the Corporation's option and in its sole discretion, out of funds legally available therefor (1) in cash, (2) in shares of Common Stock, such that the number of shares of Common Stock to be distributed with respect to the portion of the dividend attributable to each Accrual Period shall be equal to the number obtained by dividing the dollar amount of the portion of the dividend attributable to such Accrual Period by the greater of (I) the -10- 11 Current Market Price of the Common Stock on the tenth trading day immediately preceding the applicable Accrual Date and (II) $2.00 (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Common Stock), or (III) in any combination of cash and shares of Common Stock that the Corporation may determine in its sole discretion, with the number of shares of Common Stock to be distributed in connection therewith to be calculated on the basis set forth in Section B.2.(f)(iv)(A)(2). (B) No fractional shares of Common Stock or scrip shall be issued upon payment of any dividends in shares of Common Stock upon conversion or redemption of any shares of Series A Preferred Stock. If more than one share of Series A Preferred Stock shall be surrendered for conversion at any one time by the same holder, shall be held by the same holder at the time of any automatic conversion or shall be held by the same holder at the time of any redemption, as the case may be, the number of full shares of Common Stock issuable upon payment of such dividends shall be computed on the basis of the aggregate dividend amount that the Corporation has determined to pay in Common Stock shares. Instead of any fractional shares of Common Stock which would otherwise be issuable upon payment of such dividends, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the then Current Market Price, rounded to the nearest cent ($.01). (C) Notwithstanding the dividend rate otherwise applicable pursuant to Section B.2.(f)(i)(A) and notwithstanding any other provision of this Section B.2 of this Article Fourth to the contrary, in the event the Corporation pays any dividends in shares of Common Stock upon conversion or redemption of any shares of Series A Preferred Stock and pursuant to the provisions of Section B.2.(f)(iv)(A) the Current Market Price used in the calculation of the number of shares payable in respect of such dividends in respect of any Accrual Period is less than $2.00, as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Common Stock (and, therefore, pursuant to and for purposes of Section B.2.(f)(iv)(A), deemed to be equal to $2.00, as so adjusted), payment of any such dividends in shares of Common Stock calculated pursuant thereto shall constitute payment in full of any such dividends. (g) Redemption. (i) General. (A) At any time after November 9, 1995, the Corporation may redeem in whole or in part the then outstanding shares of Series A Preferred Stock; provided, however, that the Corporation may not redeem any shares of Series A Preferred Stock unless the Current Market Price of the Common Stock on a date (which date may be prior to, on or after November 9, 1995) that is within ten trading days of the date notice of redemption is given pursuant to Section B.2.(g)(iii) equals or -11- 12 exceeds $5.17 (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Common Stock). (B) The Corporation shall redeem the Series A Preferred Stock by paying a redemption amount equal to $20.00 per share of Series A Preferred Stock (the "Redemption Price"), at the Corporation's option and in its sole discretion, out of funds legally available therefor (1) in cash, (2) in shares of Common Stock, such that the number of shares of Common Stock to be distributed in payment of the Redemption Price shall be equal to the number obtained by dividing the dollar amount of the Redemption Price by the lesser of (I) the Current Market Price of the Common Stock on the tenth trading day immediately preceding the date notice of redemption is given pursuant to Section B.2.(g)(iii) and (II) the Conversion Price on the redemption payment date, or (3) in any combination of cash and shares of Common Stock that the Corporation may determine in its sole discretion, with the number of shares of Common Stock distributed in connection therewith to be calculated on the basis set forth in Section B.2.(f)(iv)(B)(2). (C) No fractional shares of Common Stock or scrip shall be issued upon payment of the Redemption Price or any portion thereof in shares of Common Stock. If more than one share of Series A Preferred Stock shall be held by the same holder at the time of any redemption, the number of full shares of Common Stock issuable upon payment of the Redemption Price, or any portion thereof, shall be computed on the basis of the aggregate Redemption Price that the Corporation has determined to pay in Common Stock shares. Instead of any fractional shares of Common Stock which would otherwise be issuable upon payment of any such Redemption Price, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the then Current Market Price, rounded to the nearest cent ($.01). (D) In connection with any redemption of shares of Series A Preferred Stock, in addition to the Redemption Price, the Corporation shall pay accrued and unpaid dividends thereon in accordance with the provisions of Section B.2.(f)(iv). (E) The Redemption Price payable pursuant hereto shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to any shares of the Series A Preferred Stock. (ii) Partial Redemption. In case of the redemption of only part of the Series A Preferred Stock at the time outstanding, at the option of the Board of Directors, such redemption shall be made pro rata or the shares to be redeemed shall be chosen by lot in such manner as may be prescribed by the Board of Directors. -12- 13 (iii) Notice. (A) Notice of any proposed redemption of Series A Preferred Stock shall be given by the Corporation by mailing a copy of such notice by first class mail, postage prepaid, not less than 30 nor more than 90 calendar days prior to the date fixed for such redemption to each holder of record of the shares to be redeemed at his address appearing on the books of the Corporation. (B) Each such notice shall state, among other things, (1) the redemption payment date, (2) whether the Redemption Price will be paid in shares of Common Stock or cash, or in a combination of Common Stock and cash, (3) that dividends on the shares to be redeemed shall cease to accrue following such redemption payment date, and (4) that dividends accrued to and including the date fixed for redemption will be paid as specified in said notice. (C) Notice having been mailed as aforesaid, from and after the redemption payment date, unless the Corporation shall be in default in providing money or Common Stock for the payment of the Redemption Price (or for any accrued and unpaid dividends to and including the redemption payment date), (1) dividends on the shares of Series A Preferred Stock so called for redemption shall cease to accrue, (2) said shares shall be deemed no longer outstanding, and (3) all rights of the holders thereof as stockholders of the Corporation (except the right to receive from the Corporation any monies or Common Stock payable upon redemption without interest thereon) shall cease except for the rights applicable to any Common Stock paid pursuant to the redemption. (iv) Conversion Prior to Redemption. The holder of any shares of Series A Preferred Stock to whom notice of redemption has been given pursuant hereto may pursuant to the provisions of Section B.2.(f) hereof elect to convert the shares of Series A Preferred Stock for which notice of redemption has been given at any time on or prior to the tenth calendar day immediately preceding the redemption payment date. (h) Reacquired Shares. Any shares of Series A Preferred Stock redeemed, purchased, converted or otherwise acquired by the Corporation in any manner whatsoever shall not be reissued as part of such series and shall be retired promptly after the acquisition thereof. All such shares shall upon their retirement and the filing of any certificate required in connection therewith pursuant to the Delaware General Corporation Law become authorized but unissued shares of Preferred Stock. C. Number of Authorized Shares. The number of authorized shares of any class of capital stock of the Corporation may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the shares of capital stock of the Corporation entitled to vote on matters submitted to a vote of the stockholders of the Corporation, and no class vote shall be required in connection therewith. -13- 14 D. No Preemptive Rights. No holder of shares of stock of the Corporation shall have any preemptive or other right, except as such rights are expressly provided herein or by contract, to purchase or subscribe for or receive any shares of any class, or series thereof, of stock of the Corporation, whether now or hereafter authorized, or any warrants, options, bonds, debentures or other securities convertible into, exchangeable for or carrying any right to purchase any shares of any class, or series thereof, of stock; but such additional shares of stock and such warrants, options, bonds, debentures or other securities convertible into, exchangeable for or carrying any right to purchase any shares of any class, or series thereof, of stock may be issued or disposed of by the Board of Directors to such persons, and on such terms and for such lawful consideration, as in its discretion it shall deem advisable or as the Corporation shall have by contract agreed. Fifth: The Corporation is to have perpetual existence. Sixth: Elections of directors need not be by written ballot unless the bylaws of the Corporation shall so provide. Seventh: A. A director of the Corporation shall not be personally liable to the Corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except for liability (i) for any breach of the director's duty of loyalty to the Corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) under Section 174 of the Delaware General Corporation Law, or (iv) for any transaction from which the director derived an improper personal benefit. If the Delaware General Corporation Law hereafter is amended to authorize the further elimination or limitation of the liability of directors, then the liability of a director of the Corporation, in addition to the limitation on personal liability provided herein, shall be limited to the fullest extent permitted by the amended Delaware General Corporation Law. Any repeal or modification of this paragraph by the stockholders of the Corporation shall be prospective only, and shall not adversely affect any limitation on the personal liability of a director of the Corporation existing at the time of such repeal or modification. B. The Corporation shall indemnify any director or officer to the full extent permitted by Delaware law. Eighth: In furtherance of, and not in limitation of, the powers conferred by statute, the Board of Directors is expressly authorized to adopt, amend or repeal the bylaws of the Corporation, or adopt new bylaws, without any action on the part of the stockholders. IN WITNESS WHEREOF, the Corporation has caused this Restated Certificate of Incorporation, which restates and integrates and also amends the Corporation's Restated Certificate of Incorporation as heretofore amended, after having been duly -14- 15 adopted by the Corporation in accordance with the provisions of Sections 242 and 245 of the Delaware General Corporation Law, to be signed by its duly authorized officer on this 20th day of June, 1995. LIFECELL CORPORATION By /s/ Paul M. Frison ------------------------------------- Paul M. Frison, Chairman of the Board, President and Chief Executive Officer -15- 16 CERTIFICATE OF AMENDMENT OF RESTATED CERTIFICATE OF INCORPORATION OF LIFECELL CORPORATION LifeCell Corporation, a Delaware corporation (the "Corporation"), does hereby certify: That the amendment set forth below to the Corporation's Restated Certificate of Incorporation was duly adopted in accordance with the provisions of Section 242 of the General Corporation Law of the State of Delaware: I. The first paragraph of Article Fourth of the Corporation's Restated Certificate of Incorporation is hereby deleted and replaced in its entirety by the following: Fourth: The total number of shares of capital stock that the Corporation shall have authority to issue is 27,000,000, of which 2,000,000 shares of the par value of $.001 per share shall be a class designated Preferred Stock ("Preferred Stock") and 25,000,000 shares of the par value of $.001 per share shall be a class designated Common Stock ("Common Stock"). 17 IN WITNESS WHEREOF, LifeCell Corporation has caused this Certificate to be signed by its duly authorized officer this 20th day of May, 1996. LIFECELL CORPORATION By /s/ Paul M. Frison ----------------------------- Paul M. Frison, President -2- 18 LIFECELL CORPORATION CERTIFICATE OF DESIGNATION OF SERIES B PREFERRED STOCK Pursuant to Section 151 of the General Corporation Law of the State of Delaware LifeCell Corporation (the "Corporation"), a corporation organized and existing under and by virtue of the General Corporation Law of the State of Delaware, does hereby certify: FIRST: That the Board of Directors of the Corporation, pursuant to a unanimous consent of the Board of Directors dated as of November 6, 1996, duly adopted the following resolution: RESOLVED, that pursuant to the authority expressly granted to and vested in the Board of Directors of the Corporation by the provisions of the Restated Certificate of Incorporation of the Corporation, out of the authorized but unissued shares of Preferred Stock of the Corporation this Board of Directors hereby creates a series of the Preferred Stock, par value $.001 per share (the "Preferred Stock"), of the Corporation, and this Board of Directors hereby fixes the powers, designations, preferences and relative, participating, optional or other special rights of the shares of such series, and the qualifications, limitations or restrictions thereof (in addition to the powers, designations, preferences and relative, participating, optional or other special rights, and the qualifications, limitations or restrictions thereof, set forth in the Restated Certificate of Incorporation of the Corporation which are applicable to Preferred Stock of all series) as follows: 1. Designation. The designation of the series shall be "Series B Preferred Stock" (the "Series B Preferred Stock"). 2. Number. The number of shares constituting the Series B Preferred Stock shall be 182,205. 3. Voting Rights. (a) General. Each share of Series B Preferred Stock shall entitle the holder thereof to one vote for each share of Common Stock, $.001 par value per share, of the Corporation (the "Common Stock"), into which such share of Series B Preferred Stock is convertible on the record date for such vote on all matters submitted to a vote of the stockholders of the Corporation. 19 (b) Directors. At any meeting of the stockholders of the Corporation held for the election of directors, the holders of Series B Preferred Stock, voting separately as a series, shall be entitled to elect three members of the Board of Directors of the Corporation. (c) Other. Without the vote or consent of the holders of at least a majority of the shares of Series B Preferred Stock then outstanding, the Corporation may not authorize or create any class or series of capital stock ranking prior to or on a parity with the Series B Preferred Stock either as to redemption or liquidation. 4. Liquidation. (a) Preference. The Series B Preferred Stock shall rank on a parity with the Series A Preferred Stock, $.001 par value per share, of the Corporation (the "Series A Preferred Stock"), with respect to liquidation. All capital stock of the Corporation other than the Series A Preferred Stock and the Series B Preferred Stock is referred to herein as the "Junior Securities". In the event of any liquidation, dissolution or winding up of the affairs of the Corporation, whether voluntary or involuntary, each holder of record of the issued and outstanding shares of Series B Preferred Stock shall be entitled to receive, out of the assets of the Corporation available for distribution to the holders of shares of Series B Preferred Stock, prior and in preference to any distribution of any of the assets of the Corporation to the holders of Junior Securities, an amount in cash equal to the aggregate Liquidation Value (as defined below) of all shares of Series B Preferred Stock then held by such holder, plus an amount equal to all dividends accrued and unpaid on such shares (whether or not declared) up to the date fixed for distribution. If, upon such liquidation, dissolution or winding up of the affairs of the Corporation, the assets of the Corporation distributable among the holders of Series B Preferred Stock, the Series A Preferred Stock and any other series of Preferred Stock ranking on a parity therewith in respect thereto or any class or series of capital stock of the Corporation ranking on a parity therewith in respect thereto shall be insufficient to permit the payment in full to all such holders of shares of the preferential amounts payable to them, then the entire assets of the Corporation available for distribution to such holders of such shares shall be distributed ratably among such holders in proportion to the respective amounts that would be payable per share if such assets were sufficient to permit payment in full. Not less than 30 days prior to the payment date stated therein, the Corporation shall mail written notice of any such liquidation, dissolution or winding up to each record holder of the Series B Preferred Stock, setting forth in reasonable detail the amount of proceeds to be paid with respect to each share of Series B Preferred Stock and each share of Common Stock in connection with such liquidation, dissolution or winding up. (b) After payment of the full amount to which they are entitled upon liquidation pursuant to Section 4(a), the holders of shares of Series B Preferred Stock shall be entitled to participate ratably in any distribution of any remaining assets of the Corporation legally available for distribution to the holders of Common Stock with the holders of record of the then issued and outstanding shares of Common Stock, as a single class, on the basis of the number of shares held by each such holder of Series B Preferred Stock (for the purposes of this Section 4(b), treating such shares of Series B -2- 20 Preferred Stock as if converted into shares of Common Stock pursuant to the provisions of this Certificate). (c) Liquidation Value; Adjustments. "The Liquidation Value" of any particular share of Series B Preferred Stock as of any particular date shall equal $100.00. The Liquidation Value shall be equitably adjusted by the Corporation to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Series B Preferred Stock. 5. Conversion Rights. The Series B Preferred Stock shall be convertible as follows: (a) Optional Conversion. Subject to and upon compliance with the provisions of this Section 5, the holder of any shares of Series B Preferred Stock shall have the right at such holder's option, at any time or from time to time, and without the payment of any additional consideration therefor, to convert any of such shares of Series B Preferred Stock into fully paid and nonassessable shares of Common Stock at the Conversion Price (as defined in Section 5(c) below) in effect on any Conversion Date (as defined in Section 5(d) below) upon the terms hereinafter set forth. (b) Automatic Conversion. Each outstanding share of Series B Preferred Stock shall automatically be converted, without any further act of the Corporation or its stockholders, at the Conversion Price then in effect, into fully paid and nonassessable shares of Common Stock on the earlier to occur of the following: (i) the date of the closing of an underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended (the "Securities Act"), covering the offering and sale of Common Stock, or of any equity security that as a part of a unit includes Common Stock, for the account of the Corporation, in which the aggregate gross proceeds received by the Corporation, net of any underwriter discounts or commissions, equals or exceeds $20,000,000, and in which the public offering price per share of Common Stock equals or exceeds $9.30 (as equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares); and (ii) the date first occurring after the closing of an underwritten public offering pursuant to an effective registration statement under the Securities Act covering the offering and sale of Common Stock, or of any equity security that as a part of a unit includes Common Stock, for the account of the Corporation, in which the aggregate gross proceeds received by the Corporation, net of any underwriter discounts or commissions, equals or exceeds $20,000,000, on which the Current Market Price (as defined in the first sentence of Section 5(j) below) of the Common Stock equals or exceeds $9.30 (as equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares). -3- 21 (c) Number of Conversion Shares. Each share of Series B Preferred Stock shall be convertible pursuant to Sections 5(a) and 5(b) into a number of shares of Common Stock determined by dividing (i) the Liquidation Value (as it may be adjusted pursuant to Section 4(c) hereof) by (ii) the Conversion Price in effect on any Conversion Date. For the purposes of this Section 5, the term "Conversion Price" shall initially mean $3.10. In order to prevent dilution of the conversion rights granted under this Section 5, the Conversion Price shall be subject to adjustment from time to time pursuant to Section 5(f). (d) Conversion Procedures. The holder of any shares of Series B Preferred Stock may exercise the conversion right specified in Section 5(a) by surrendering to the Corporation or any transfer agent of the Corporation the certificate or certificates for the shares to be converted, accompanied by written notice specifying the number of shares to be converted. Upon the occurrence of automatic conversion pursuant to Section 5(b), the outstanding shares of Series B Preferred Stock shall be converted automatically without any further action by the holders of such shares and whether or not the certificates representing such shares are surrendered to the Corporation or its transfer agent; provided that the Corporation shall not be obligated to issue to any holder certificates evidencing the shares of Common Stock issuable upon such conversion unless certificates evidencing such shares of Series B Preferred Stock are delivered either to the Corporation or any transfer agent of the Corporation. Conversion shall be deemed to have been effected on the date when delivery of notice of an election to convert and of certificates for shares being converted is made or on a date specified in Section 5(b), as the case may be, and such date is referred to herein as the "Conversion Date". Subject to the provisions of Section 5(f)(iv), as promptly as practicable thereafter (and after surrender of the certificate or certificates representing shares of Series B Preferred Stock to the Corporation or any transfer agent of the Corporation in the case of conversion pursuant to Section 5(b)) the Corporation shall issue and deliver to or upon the written order of such holder a certificate or certificates for the number of full shares of Common Stock to which such holder is entitled and a check or cash with respect to any fractional interest in a share of Common Stock as provided in Section 5(e). Subject to the provisions of Section 5(f)(iv), the person in whose name the certificate or certificates for Common Stock are to be issued shall be deemed to have become a holder of record of such Common Stock on the applicable Conversion Date. Upon conversion of only a portion of the number of shares covered by a certificate representing shares of Series B Preferred Stock surrendered for conversion (in the case of conversion pursuant to Section 5(a)), the Corporation shall issue and deliver to or upon the written order of the holder of the certificate so surrendered for conversion, at the expense of the Corporation, a new certificate covering the number of shares of Series B Preferred Stock representing the unconverted portion of the certificate so surrendered. (e) Fractional Shares. No fractional shares of Common Stock or scrip shall be issued upon conversion of shares of Series B Preferred Stock. If more than one share of Series B Preferred Stock shall be surrendered for conversion at any one time by the same holder or shall be held by the same holder at the time of any automatic conversion, the number of full shares of Common Stock issuable upon conversion thereof shall be computed on the basis of the aggregate number of shares so -4- 22 surrendered or held, as the case may be. Instead of any fractional shares of Common Stock which would otherwise be issuable upon conversion of any shares of Series B Preferred Stock, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the then Current Market Price (as defined in Section 5(j) below), rounded to the nearest cent ($.01). (f) Conversion Price Adjustments. The Conversion Price shall be subject to adjustment from time to time as follows: (i) If and whenever on or after the date of the original issuance of the Series B Preferred Stock, the Corporation issues or sells, or in accordance with Section 5(g) is deemed to have issued or sold, any shares of its Common Stock (other than Excluded Stock) for a consideration per share less than the Conversion Price in effect immediately prior to the time of such issue or sale, or deemed issue or sale then immediately upon such issue or sale or deemed issue or sale the Conversion Price shall be reduced to the Conversion Price determined by dividing (A) the sum of (1) the product derived by multiplying the Conversion Price in effect immediately prior to such issue or sale or deemed issue or sale by the number of shares of Common Stock Deemed Outstanding immediately prior to such issue or sale or deemed issue or sale, plus (2) the consideration, if any, received by the Corporation upon such issue or sale or deemed issue or sale, by (B) the number of shares of Common Stock Deemed Outstanding immediately after such issue or sale or deemed issue or sale. (ii) For purposes of this Section 5, "Excluded Stock" means (A) Common Stock issued or reserved for issuance by the Company as a dividend on Preferred Stock or upon any subdivision or split-up of the outstanding shares of any shares of capital stock of the Company or any recapitalization thereof, or upon conversion of any shares of Preferred Stock, (B) Common Stock issuable pursuant to any options, warrants or other rights that are outstanding on the effective date of this Certificate, (C) Common Stock issued or issuable in connection with a Board-approved acquisition of a business by the Company as a result of which the Company owns in excess of 50% of the voting power of such business, (D) Common Stock issued or issuable to employees, officers, consultants, directors or vendors of the Company or pursuant to any Board-approved employee, officer, consultant or director benefit plan, including without limitation any stock option plan, and (E) Common Stock issued or issuable to (1) banks, savings and loan associations, equipment lessors or similar lending institutions in connection with such entities providing Board-approved credit facilities or equipment financings to the Company or (2) any party to any technology transfer agreement, distribution agreement, marketing agreement or any other agreement similar thereto, with the Company, as approved by the Board. For purposes of this Section 5, "Common Stock Deemed Outstanding" means, at any given time, the number of shares of Common Stock actually outstanding at such time, plus the number of shares of Common Stock deemed to be outstanding pursuant to Sections 5(g)(i) and 5(g)(ii) hereof regardless of -5- 23 whether Options (as defined below) or Convertible Securities (as defined below) are actually exercised or converted at such time. (iii) All calculations under this Section 5(f) shall be made to the nearest cent ($.01) or to the nearest one hundredth (1/100th) of a share, as the case may be. Any provision of this Section 5 to the contrary notwithstanding, no adjustment in the Conversion Price shall be made if the amount of such adjustment would be less than 1% of the then current Conversion Price until the end of the calendar year after such adjustment would otherwise have been required; but any such amount shall be carried forward and an adjustment with respect thereto shall be made at the time of and together with any subsequent adjustment which, together with such amount and any other amount or amounts so carried forward, shall aggregate 1% of the then current Conversion Price or more, provided that if the events giving rise to such adjustments occur within three months of each other, then such adjustments shall be calculated as if these events giving rise to them had occurred simultaneously on the date of the first such event. (iv) In any case in which the provisions of this Section 5(f) shall require that an adjustment shall become effective immediately after a record date for an event, the Corporation may defer until the occurrence of such event (A) issuing to the holder of any share of Series B Preferred Stock converted after such record date and before the occurrence of such event the additional shares of Common Stock issuable upon such conversion by reason of the adjustment required by such event over and above the shares of Common Stock issuable upon such conversion before giving effect to such adjustment and (B) paying to such holder any amount of cash in lieu of a fractional share of Common Stock pursuant to Section 5(e); provided that the Corporation upon request shall deliver to such holder a due bill or other appropriate instrument evidencing such holder's right to receive such additional shares, and such cash, upon the occurrence of the event requiring such adjustment. (g) Effect on Conversion Price of Certain Events. For purposes of determining the adjusted Conversion Price under Section 5(f), the following shall be applicable: (i) Issuance of Rights or Options. If the Corporation in any manner grants or sells any rights to subscribe for or purchase Common Stock or Convertible Securities ("Options") and the price per share for which Common Stock is issuable upon the exercise of such Options, or upon conversion or exchange of any stock or securities (directly or indirectly) convertible into or exchangeable for Common Stock ("Convertible Securities") issuable upon exercise of such Options, is less than the Conversion Price in effect immediately prior to the time of the granting or sale of such Options, then the total maximum number of shares of Common Stock issuable upon the exercise of such Options or upon conversion or exchange of the total maximum amount of such Convertible Securities issuable upon the exercise of such Options shall be deemed -6- 24 to be outstanding and to have been issued and sold by the Corporation at the time of the granting or sale of such Options for such price per share. For purposes of this paragraph, the "price per share for which Common Stock is issuable" shall be determined by dividing (A) the total amount, if any, received or receivable by the Corporation as consideration for the granting or sale of such Options, plus the minimum aggregate amount of additional consideration payable to the Corporation upon exercise of all such Options, plus in the case of such Options which relate to Convertible Securities, the minimum aggregate amount of additional consideration, if any, payable to the Corporation upon the issuance or sale of such Convertible Securities and the conversion or exchange thereof, by (B) the total maximum number of shares of Common Stock issuable upon the exercise of such Options or upon the conversion or exchange of all such Convertible Securities issuable upon the exercise of such Options. No further adjustment of the Conversion Price shall be made when Convertible Securities are actually issued upon the exercise of such Options or when Common Stock is actually issued upon the exercise of such Options or the conversion or exchange of such Convertible Securities. (ii) Issuance of Convertible Securities. If the Corporation in any manner issues or sells any Convertible Securities and the price per share for which Common Stock is issuable upon conversion or exchange thereof is less than the Conversion Price in effect immediately prior to the time of such issue or sale, then the maximum number of shares of Common Stock issuable upon conversion or exchange of such Convertible Securities shall be deemed to be outstanding and to have been issued and sold by the Corporation at the time of the issuance or sale of such Convertible Securities for such price per share. For the purposes of this paragraph, the "price per share for which Common Stock is issuable" shall be determined by dividing (A) the total amount received or receivable by the Corporation as consideration for the issue or sale of such Convertible Securities, plus the minimum aggregate amount of additional consideration, if any, payable to the Corporation upon the conversion or exchange thereof, by (B) the total maximum number of shares of Common Stock issuable upon the conversion or exchange of all such Convertible Securities. No further adjustment of the Conversion Price shall be made when Common Stock is actually issued upon the conversion or exchange of such Convertible Securities, and if any such issue or sale of such Convertible Securities is made upon exercise of any Options for which adjustments of the Conversion Price had been or are to be made pursuant to other provisions of this Section 5(g), no further adjustment of the Conversion Price shall be made by reason of such issue or sale. (iii) Change in Option Price or Conversion Rate. If the purchase price provided for in any Options, the additional consideration, if any, payable upon the conversion or exchange of any Convertible Securities or the rate at which any Convertible Securities are convertible into or exchangeable for Common Stock changes at any time, the Conversion Price in effect at the time of such change shall be immediately adjusted to the Conversion Price which would have been in effect at such time had such Options or Convertible Securities still outstanding provided for such changed purchase price, additional -7- 25 consideration or conversion rate, as the case may be, at the time initially granted, issued or sold; provided that if such adjustment would result in an increase of the Conversion Price then in effect, such adjustment shall not be effective until 30 days after written notice thereof has been given by the Corporation to all holders of the Series B Preferred Stock. For purposes of this Section 5(g), if the terms of any Option or Convertible Security which was outstanding as of the date of issuance of the Series B Preferred Stock are changed in the manner described in the immediately preceding sentence, then such Option or Convertible Security and the Common Stock deemed issuable upon exercise, conversion or exchange thereof shall be deemed to have been issued as of the date of such change. (iv) Treatment of Expired Options and Unexercised Convertible Securities. Upon the expiration of any Option or the termination of any right to convert or exchange any Convertible Security without the exercise of any such Option or right, the Conversion Price then in effect hereunder shall be adjusted immediately to the Conversion Price which would have been in effect at the time of such expiration or termination had such Option or Convertible Security, to the extent outstanding immediately prior to such expiration or termination, never been issued; provided that if such expiration or termination would result in an increase in the Conversion Price in effect, such increase shall not be effective until 30 days after written notice thereof has been given to all holders of the Series B Preferred Stock. For purposes of this Section 5(g), the expiration or termination of any Option or Convertible Security which was outstanding as of the date of issuance of the Series B Preferred Stock shall not cause the Conversion Price hereunder to be adjusted unless, and only to the extent that, a change in the terms of such Option or Convertible Security caused it to be deemed to have been issued after the date of issuance of the Series B Preferred Stock. (v) Calculation of Consideration Received. If any Common Stock, Option or Convertible Security is issued or sold or deemed to have been issued or sold for cash, the consideration received therefor shall be deemed to be the gross amount received by the Corporation therefor (net of any underwriter, placement agent or broker discounts and commissions). If any Common Stock, Option or Convertible Security is issued or sold for a consideration other than cash, the amount of the consideration other than cash received by the Corporation shall be the fair value of such consideration, except where such consideration consists of securities, in which case the amount of consideration received by the Corporation shall be the Current Market Price thereof as of the date of receipt. If any Common Stock, Option or Convertible Security is issued to the owners of the non-surviving entity in connection with any merger in which the Corporation is the surviving corporation, the amount of consideration therefor shall be deemed to be the fair value of such portion of the net assets and business of the non-surviving entity as is attributable to such Common Stock, Option or Convertible Security, as the case may be. The fair value of any consideration other than cash and securities shall be determined jointly by the Corporation and the holders of a majority of the outstanding Series B Preferred -8- 26 Stock. If such parties are unable to reach an agreement within a reasonable period of time, the fair value of such consideration shall be determined by an independent appraiser experienced in valuing such type of consideration jointly selected by the Corporation and the holders of a majority of the outstanding Series B Preferred Stock. The determination of such appraiser shall be final and binding upon the parties, and the fees and expenses of such appraiser shall be borne by the Corporation. (vi) Integrated Transactions. In case any Option is issued in connection with the issue or sale of other securities of the Corporation, together comprising one integrated transaction in which no specific consideration is allocated to such Option by the parties thereto, the Option shall be deemed to have been issued for a consideration of $.01. (vii) Treasury Shares. For the purpose of this Section 5, the number of shares of Common Stock outstanding at any given time shall not include shares owned or held by or for the account of the Corporation or any subsidiary, and the disposition of any shares so owned or held shall be considered an issue or sale of Common Stock. (viii) Record Date. If the Corporation takes a record of the holders of Common Stock for the purpose of entitling them (A) to receive a dividend or other distribution payable in Common Stock, Options or in Convertible Securities or (B) to subscribe for or purchase Common Stock, Options or Convertible Securities, then such record date shall be deemed to be the date of the issue or sale of the shares of Common Stock deemed to have been issued or sold upon the declaration of such dividend or upon the making of such other distribution or the date of the granting of such right of subscription or purchase, as the case may be. (h) Subdivision or Combination of Common Stock. If the Corporation at any time subdivides (by any stock split, stock dividend, recapitalization or otherwise) one or more classes of its outstanding shares of Common Stock into a greater number of shares, the Conversion Price in effect immediately prior to such subdivision shall be proportionately reduced, and if the Corporation at any time combines (by reverse stock split or otherwise) one or more classes of its outstanding shares of Common Stock into a smaller number of shares, the Conversion Price in effect immediately prior to such combination shall be proportionately increased. (i) Reorganization, Reclassification, Consolidation, Merger or Sale. Any recapitalization, reorganization, reclassification, consolidation, merger, sale of all or substantially all of the Corporation's assets or other transaction, in each case which is effected in such a manner that the holders of Common Stock are entitled to receive (either directly or upon subsequent liquidation) stock, securities or assets with respect to or in exchange for Common Stock, is referred to herein as an "Organic Change". Prior to the consummation of any Organic Change, the Corporation shall make appropriate provisions (in form and substance satisfactory to the holders of a majority of the Series B Preferred Stock then outstanding) to insure that each of the holders of -9- 27 Series B Preferred Stock shall thereafter have the right to acquire and receive, in lieu of or in addition to (as the case may be) the shares of Common Stock immediately theretofore acquirable and receivable upon the conversion of such holder's Series B Preferred Stock, such shares of stock, securities or assets as such holder would have received in connection with such Organic Change if such holder had converted its Series B Preferred Stock immediately prior to such Organic Change. In each such case, the Corporation shall also make appropriate provisions (in form and substance satisfactory to the holders of a majority of the Series B Preferred Stock then outstanding) to insure that the provisions of this Section 5 and Sections 4, 6 and 7 hereof shall thereafter be applicable to the Series B Preferred Stock (including, in the case of any such consolidation, merger or sale in which the successor entity or purchasing entity is other than the Corporation, an immediate adjustment of the Conversion Price to the value for the Common Stock reflected by the terms of such consolidation, merger or sale, and a corresponding immediate adjustment in the number of shares of Common Stock acquirable and receivable upon conversion of Series B Preferred Stock, if the value so reflected is less than the Conversion Price in effect immediately prior to such consolidation, merger or sale). The Corporation shall not effect any such consolidation, merger or sale, unless prior to the consummation thereof, the successor entity (if other than the Corporation) resulting from consolidation or merger or the entity purchasing such assets assumes by written instrument (in form and substance satisfactory to the holders of a majority of the Series B Preferred Stock then outstanding), the obligation to deliver to each such holder such shares of stock, securities or assets as, in accordance with the foregoing provisions, such holder may be entitled to acquire. (j) Current Market Price. The "Current Market Price" means as to any security the average of the closing prices of such security's sales on all domestic or foreign securities exchanges on which such security may at the time be listed, or, if there have been no sales on any such exchange on any day, the average of the highest bid and lowest asked prices on all such exchanges at the end of such day, or, if on any such day security is not so listed, the average of the representative bid and asked prices quoted in the NASDAQ National Market or NASDAQ SmallCap Market, as of 4:00 P.M., New York time, on such day, or, if on any day such security is not quoted in the NASDAQ National Market or the NASDAQ SmallCap Market (as applicable), the average of the highest bid and lowest asked prices on such day in the domestic over-the-counter market as reported by the National Quotation Bureau, Incorporated, or any similar successor organization, in each such case averaged over a period of 30 days consisting of the day as of which "Current Market Price" is being determined and the 29 consecutive business days prior to such day; provided that if such security is listed on any domestic securities exchange the term "business days" as used in this sentence means business days on which such exchange is open for trading. If at any time such security is not listed on any domestic securities exchange or quoted in the NASDAQ National Market or the NASDAQ SmallCap Market or the domestic over-the-counter market, the "Current Market Price" shall be the fair value thereof determined jointly by the Corporation and the holders of shares of Series B Preferred Stock representing a majority of the shares of Series B Preferred Stock then outstanding; provided that if such parties are unable to reach agreement within a reasonable period of time, such fair value shall be determined by an appraiser jointly -10- 28 selected by the Corporation and the holders of shares of Series B Preferred Stock representing a majority of the shares of shares of Series B Preferred Stock then outstanding. The determination of such appraiser shall be final and binding on the Corporation and the holders of the shares of Series B Preferred Stock and the fees and expenses of such appraiser shall be paid by the Corporation. (k) Statement Regarding Adjustments. Whenever the Conversion Price shall be adjusted as provided in this Section 5, the Corporation shall forthwith file, at the office of any transfer agent for the Series B Preferred Stock and at the principal office of the Corporation, a statement showing in detail the method of calculation of such adjustment, the facts requiring such adjustment and the Conversion Price that shall be in effect after such adjustment, and the Corporation shall also cause a copy of such statement to be sent by mail, first class postage prepaid, to each holder of shares of Series B Preferred Stock at its address appearing on the Corporation's records. Each such statement shall be signed by the Corporation's chief financial officer. Where appropriate, such copy may be given in advance and may be included as part of a notice required to be mailed under the provisions of Section 5(l). (l) Notice to Holders. In the event the Corporation shall propose to take any action of the type described in this Section 5, the Corporation shall give notice to each holder of shares of Series B Preferred Stock in the manner set forth in Section 5(k), which notice shall specify the record date, if any, with respect to any such action and the approximate date on which such action is to take place. Such notice shall also set forth such facts with respect thereto as shall be reasonably necessary to indicate the effect of such action (to the extent such effect may be known at the date of such notice) on the Conversion Price and the number, kind or class of shares or other securities or property which shall be deliverable upon conversion of shares of Series B Preferred Stock. In the case of any action which would require the fixing of a record date, such notice shall be given at least ten calendar days prior to the date so fixed, and in the case of all other action, such notice shall be given at least 15 calendar days prior to the taking of such proposed action. Failure to give such notice, or any defect therein, shall not affect the legality or validity of any such action. (m) Costs. The Corporation shall pay all documentary, stamp, transfer or other transactional taxes attributable to the issuance or delivery of shares of Common Stock upon conversion of any shares of Series B Preferred Stock; provided that the Corporation shall not be required to pay any taxes which may be payable in respect of any transfer involved in the issuance or delivery of any certificate for such shares in a name other than that of the holder of the shares of Series B Preferred Stock in respect of which such shares are being issued. (n) Dividends Upon Conversion. In connection with any conversion of shares of Series B Preferred Stock, the Corporation shall pay accrued and unpaid dividends thereon in accordance with the provisions of Section 7(d). -11- 29 (o) Certain Events. If any event occurs of the type contemplated by the provisions of Section 5(f)(i) but not expressly provided for by such provisions, then the Conversion Price shall be adjusted by the Corporation's Board of Directors in good faith so as to protect the rights of the holders of Series B Preferred Stock; provided that no such adjustment shall increase the Conversion Price as otherwise determined pursuant to this Section 5 or decrease the number of shares of Common Stock issuable upon conversion of each share of Series B Preferred Stock. 6. Purchase Rights. If at any time the Corporation grants, issues or sells any Options, Convertible Securities or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of Common Stock (the "Purchase Rights"), then each holder of Series B Preferred Stock shall be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which such holder could have acquired if such holder had held the number of shares of Common Stock acquirable upon conversion of such holder's Series B Preferred Stock immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or if no such record is taken, the date as of which the record holders of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights. 7. Dividends. (a) General. (i) The Series B Preferred Stock shall rank on parity with the Series A Preferred Stock with respect to dividends. During the period commencing on the date on which the first share of Series B Preferred Stock is issued and terminating on the fifth anniversary of such date, the holders of the Series B Preferred Stock shall be entitled to receive, when and as declared by the Board of Directors out of funds legally available therefor, cumulative dividends per share of Series B Preferred Stock at the rate per annum equal to the greater of (A), if any shares of Series A Preferred Stock are then outstanding, the per annum rate of dividends per share of Series A Preferred Stock then payable thereon, (B) $6.00 (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Series A Preferred Stock or Series B Preferred Stock, as the case may be) and (C) the per annum rate of dividends per share paid by the Corporation on the Common Stock. (ii) Dividends on the Series B Preferred Stock will accrue on each March 31, June 30, September 30 and December 31, occurring after the date of original issuance (each such date being referred to herein as an "Accrual Date" and the three-month period or portion thereof, as the case may be, ending on an Accrual Date being referred to herein as an "Accrual Period"), whether or not such dividends have been declared, and whether or not there are funds of the Corporation legally available for the payment of dividends, and will cease accruing on September 30, 2001. -12- 30 Dividends will be paid (when and as declared by the Board of Directors of the Corporation) quarterly, in arrears, on each February 15, May 15, August 15 and November 15, occurring in 1997, 1998, 1999, 2000 and 2001. Each such dividend shall be paid to the holders of record of shares of the Series B Preferred Stock as they appear on the stock register of the Corporation on such record date not exceeding 45 nor less than ten calendar days preceding the payment date thereof, as shall be fixed by the Board of Directors of the Corporation. Dividends on account of arrears for any past dividend periods may be declared and paid at any time, without reference to any regular dividend payment date, to holders of record on such date, not exceeding 45 nor less than ten calendar days preceding the payment date thereof, as may be fixed by the Board of Directors of the Corporation. Holders of shares of Series B Preferred Stock at the close of business on a dividend payment record date will be entitled to receive the dividend payable with respect to such shares on the corresponding dividend payment date notwithstanding the conversion thereof or the Corporation's default on payment of the dividend due on such dividend payment date. For shares of Series B Preferred Stock surrendered for conversion during the period from the close of business on any dividend payment record date to the opening of business on the corresponding dividend payment date, the Corporation shall pay the dividend to the holder of such shares on the dividend payment record date. Except as so provided above and in Section 7(d) below, no payment or adjustment will be made on account of accrued or unpaid dividends upon conversion of shares of Series B Preferred Stock. (iii) The Corporation shall pay the dividends on the Series B Preferred Stock described in Section 7(a)(i), at the Corporation's option and in its sole discretion, out of funds legally available therefor (A) in cash, (B) in shares of Series B Preferred Stock having an aggregate Liquidation Value (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Series B Preferred Stock) at the time of such payment equal to the amount of the dividend to be paid, or (C) in any combination of cash and shares of Series B Preferred Stock that the Corporation may determine in its sole discretion, with the number of shares of Series B Preferred Stock to be distributed in connection therewith to be calculated on the basis set forth in Section 7(a)(iii)(B). (iv) No fractional shares of Series B Preferred Stock or scrip shall be issued upon payment of any dividends in shares of Series B Preferred Stock. If more than one share of Series B Preferred Stock shall be held by the same holder at the time of any dividend payment date, the number of full shares of Series B Preferred Stock issuable upon payment of such dividends shall be computed on the basis of the aggregate dividend amount that the Corporation has determined to pay in Series B Preferred Stock shares. Instead of any fractional shares of Series B Preferred Stock which would otherwise be issuable upon payment of such dividends, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the Liquidation Value (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Series B Preferred Stock), rounded to the nearest cent ($.01). -13- 31 (b) Allocation of Dividends. Dividends on the Series B Preferred Stock, if paid, or if declared and set apart for payment, must be paid or declared and set apart for payment on all outstanding shares of Series B Preferred Stock contemporaneously. In the event dividends on the Series B Preferred Stock and any other series of Preferred Stock ranking on a parity therewith in respect thereto or any other class or series of capital stock of the Corporation ranking on a parity therewith in respect thereto are declared and paid in an amount less than all accumulated and current dividends on all of such shares, the total amount declared and paid shall be allocated among all of such shares so that the per share dividend to be declared and paid on each share is the same percentage of the sum of the accumulated dividends for each such share. In the event dividends are declared and paid on the Series B Preferred Stock in a combination of cash and shares of Series B Preferred Stock, the percentage of the dividend paid in cash and the percentage of the dividend paid in stock must be the same for each share of Series B Preferred Stock. (c) Dividends on Conversion. (i) Immediately prior to the conversion of any shares of Series B Preferred Stock into Common Stock, all accrued and unpaid dividends payable pursuant to Section 7 (whether or not declared) on such shares so converted (prorated until the date of conversion in respect of the Accrual Period in which such date occurs) shall be payable, at the Corporation's option and in its sole discretion, out of funds legally available therefor (A) in cash, (B) in shares of Series B Preferred Stock, such that the number of shares of Series B Preferred Stock to be distributed with respect to the portion of the dividend attributable to each Accrual Period shall have an aggregate Liquidation Value (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, subdivision of shares or reclassification of shares with respect to the Series B Preferred Stock) at the time of such payment equal to the amount of the dividend to be paid, or (C) in any combination of cash and shares of Series B Preferred Stock that the Corporation may determine in its sole discretion, with the number of shares of Common Stock to be distributed in connection therewith to be calculated on the basis set forth in Section 7(c)(i)(B). (ii) No fractional shares of Series B Preferred Stock or scrip shall be issued upon payment of any dividends in shares of Series B Preferred Stock upon conversion of any shares of Series B Preferred Stock. If more than one share of Series B Preferred Stock shall be surrendered for conversion at any one time by the same holder, or shall be held by the same holder at the time of any automatic conversion, the number of full shares of Series B Preferred Stock issuable upon payment of such dividends shall be computed on the basis of the aggregate dividend amount that the Corporation has determined to pay in Series B Preferred Stock shares. Instead of any fractional shares of Series B Preferred Stock which would otherwise be issuable upon payment of such dividends, the Corporation shall pay out of funds legally available therefor a cash adjustment in respect of such fractional interest, rounded to the nearest one hundredth (1/100th) of a share, in an amount equal to that fractional interest of the Liquidation Value (as shall be equitably adjusted to reflect any stock dividend, stock distribution, stock split or reverse stock split, combination of shares, -14- 32 subdivision of shares or reclassification of shares with respect to the Series B Preferred Stock), rounded to the nearest cent ($.01). 8. Reacquired Shares. Any shares of Series B Preferred Stock redeemed, purchased, converted or otherwise acquired by the Corporation in any manner whatsoever shall not be reissued as part of such series and shall be retired promptly after the acquisition thereof. All such shares shall upon their retirement and the filing of any certificate required in connection therewith pursuant to the Delaware General Corporation Law become authorized but unissued shares of Preferred Stock. SECOND: That said determination of the powers, designation, preferences and the relative, participating, optional or other rights, and the qualifications, limitations or restrictions thereof, relating to said series of Preferred Stock, was duly made by the Board of Directors of the Corporation pursuant to the provisions of the Restated Certificate of Incorporation of the Corporation, as amended, and in accordance with the provisions of Section 151 of the General Corporation Law of the State of Delaware. -15- 33 IN WITNESS WHEREOF, said Corporation has caused this Certificate to be signed by Paul M. Frison, its President, on this 13th day of November, 1996. LIFECELL CORPORATION By /s/ Paul. M. Frison ------------------------------------- Paul M. Frison, President -16- 34 CERTIFICATE OF RETIREMENT OF SERIES A PREFERRED STOCK OF LIFECELL CORPORATION (Pursuant to Section 243 of the General Corporation Law of the State of Delaware) LifeCell Corporation, a Delaware corporation (the "Company"), certified as follows: FIRST: Article Fourth of the Company's Restated Certificate of Incorporation, as amended, authorizes the issuance of 300,000 shares of Series A Preferred Stock, par value $.001 per share (the "Series A Preferred Stock"). SECOND: On June 19, 1997, the Board of Directors of the Company, by resolution, retired 300,000 shares of Series A Preferred Stock, which shares constituted all of the authorized shares of Series A Preferred Stock. THIRD: Article Fourth of the Company's Restated Certificate of Incorporation, as amended, prohibits the reissuance of such shares as Series A Preferred Stock, and, therefore, such shares are restored to the status of authorized but undesignated shares of preferred stock of the Company. FOURTH: Pursuant to the provisions of Section 243 of the General Corporation Law of Delaware, all reference to Series A Preferred Stock in the Restated Certificate of Incorporation, as amended, of the Company are hereby eliminated. IN WITNESS WHEREOF, LifeCell Corporation has caused this certificate to be signed and attested by Paul M. Frison, its duly authorized officer this 19th day of June, 1997. LIFECELL CORPORATION By: /s/ PAUL M. FRISON ------------------------------------ Paul M. Frison, Chairman of the Board, President and Chief Executive Officer EX-23.1 3 CONSENT OF ARTHUR ANDERSEN LLP 1 EXHIBIT 23.1 CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS As independent public accountants, we hereby consent to the incorporation of our report included in this Form 10-K, into the Company's previously filed Registration Statements File No. 33-90740 and File No. 333-20093. ARTHUR ANDERSEN LLP Houston, Texas March 5, 1998 EX-27 4 FINANCIAL DATA SCHEDULE
5 12-MOS DEC-31-1997 DEC-31-1997 20,781,026 0 1,179,594 (83,690) 936,398 22,911,554 2,203,786 (1,339,728) 24,155,598 2,395,995 0 0 125 11,013 299,480 24,155,598 4,904,971 6,446,180 2,540,644 12,584,815 0 0 0 (6,138,635) 0 0 0 0 0 (6,138,635) (1.04) (1.04)
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