| ORTHOLOGIC CORP Item 1A Risk Factors Risks OrthoLogic may from time to time make written or oral forward-looking statements, including statements contained in our filings with the Securities and Exchange Commission and our reports to stockholders |
| The safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 protects companies from liability for their forward looking statements if they comply with the requirements of that Act |
| This Annual Report on Form 10-K contains forward-looking statements made pursuant to that safe harbor |
| These forward-looking statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and 13 _________________________________________________________________ [46]Table of Contents other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements |
| In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other comparable terminology |
| You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could materially affect actual results, levels of activity, performance or achievements |
| Factors that may cause actual results to differ materially from current expectations, which we describe in more detail in this section titled “Risks,” include, but are not limited to: • unfavorable results of our product candidate development efforts; • unfavorable results of our pre-clinical or clinical testing; • delays in obtaining, or failure to obtain FDA approvals; • increased regulation by the FDA and other agencies; • the introduction of competitive products; • impairment of license, patent or other proprietary rights; • failure to achieve market acceptance of our products; • the impact of present and future collaborative agreements; and • failure to successfully implement our drug development strategy |
| If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from what we projected |
| Any forward-looking statement you read in this Annual Report on Form 10-K reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, business strategy and liquidity |
| We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future |
| Risks of our Business We are a biopharmaceutical company with no revenue generating operations and high investment costs |
| We expect to incur losses for a number of years as we expand our research and development projects |
| There is no assurance that our current level of funds will be sufficient to support all research expenses to achieve commercialization of any of our product candidates |
| On November 26, 2003, we sold all of our revenue generating operations |
| We are now focused on developing and testing the product candidates in our Chrysalin Product Platform and have allocated most of our resources to bringing these product candidates to the market |
| However, as described earlier, on February 27, 2006 we acquired the rights to AZX100, and we also intend to continue preclinical activities on AZX100 in 2006 |
| We may invest in other peptide or small molecule-based therapeutics in the future, but there can be no assurance that opportunities of this nature will occur at acceptable terms, conditions or timing |
| We currently have no pharmaceutical products being sold or ready for sale and do not expect to be able to introduce any pharmaceutical products for at least several years |
| As a result of our significant research and development, clinical development, regulatory compliance and general and administrative expenses and the lack of any products to generate revenue, we expect to incur losses for at least the next several years and expect that our losses will increase as we expand our research and development activities and incur significant expenses for clinical trials |
| Our cash reserves, including the cash received from the sale of our bone growth stimulation device business in November 2003, are the primary source of our working 14 _________________________________________________________________ [47]Table of Contents capital |
| There can be no assurance that our cash resources will be sufficient to cover our future operating requirements, or should there be a need, other sources of cash will be available, or if available, at acceptable terms |
| We do not expect to receive any revenue from product sales until we receive regulatory approval and begin commercialization of our product candidates |
| We cannot predict when that will occur or if it will occur |
| We caution that our future cash expenditure levels are difficult to forecast because the forecast is based on assumptions about the number of research projects we pursue, the pace at which we pursue them, the quality of the data collected and the requests of the FDA to expand, narrow or conduct additional clinical trials and analyze data |
| Changes in any of these assumptions can change significantly our estimated cash expenditure levels |
| However, absent any unforeseen changes to our current business plans, we intend to maintain annual expenditure levels within the dlra32 — dlra40 million range |
| Our product candidates are in various stages of development and may not be successfully developed or commercialized |
| If we fail to commercialize our product candidates, we will not be able to generate revenue |
| Our product candidates are at the following stages of development: • Acceleration of Fracture Repair Phase 3 human clinical trials • Diabetic Foot Ulcer Healing Phase 1/2 human clinical trials • Spine Fusion Phase 1/2 human clinical trials • Cartilage Defect Repair Late stage pre-clinical trials • Tendon Repair Early stage pre-clinical trials • Cardiovascular Repair Pre-clinical trials • Dental Bone Repair Pre-clinical trials We are subject to the risk that: • the FDA finds some or all of our product candidates ineffective or unsafe; • we do not receive necessary regulatory approvals; • we are unable to get some or all of our product candidates to market in a timely manner; • we are not able to produce our product candidates in commercial quantities at reasonable costs; • our products undergo post-market evaluations resulting in marketing restrictions or withdrawal of our products; or • the patients, insurance and/or physician community does not accept our products |
| In addition, our product development programs may be curtailed, redirected or eliminated at any time for many reasons, including: • adverse or ambiguous results; • undesirable side effects which delay or extend the trials; • inability to locate, recruit, qualify and retain a sufficient number of patients for our trials; • regulatory delays or other regulatory actions; • difficulties in obtaining sufficient quantities of the particular product candidate or any other components needed for our pre-clinical testing or clinical trials; • change in the focus of our development efforts; and • re-evaluation of our clinical development strategy |
| 15 _________________________________________________________________ [48]Table of Contents We cannot predict whether we will successfully develop and commercialize any of our product candidates |
| If we fail to do so, we will not be able to generate revenue |
| The majority of our product candidates are all based on the same chemical peptide, Chrysalin |
| If one of our Chrysalin product candidates reveals safety or fundamental inefficacy issues in clinical trials, it could impact the development path for all our other current Chrysalin product candidates |
| The development of each of our product candidates in the Chrysalin Product Platform is based on our knowledge and understanding of how the human thrombin molecule contributes to the repair of soft tissue and bone |
| While there are important differences in each of the product candidates in terms of their purpose (fracture repair, diabetic foot ulcer, etc), each product candidate is focused on accelerating the repair of soft tissue and bone and is based on the ability of Chrysalin to mimic specific attributes of the human thrombin molecule to stimulate the body’s natural healing processes |
| Since we are developing the product candidates in the Chrysalin Product Platform in parallel, we expect to learn from the results of each trial and apply some of our findings to the development of the other product candidates in the platform |
| If one of the product candidates has negative clinical trial results or is shown to be ineffective, it could impact the development path or future development of the other product candidates in the platform |
| If we find that one of the biopharmaceutical product candidates is unsafe, it could impact the development of our other product candidates in clinical trials |
| If we cannot protect the Chrysalin patent or our intellectual property generally, our ability to develop and commercialize our Chrysalin products will be severely limited |
| Our success will depend in part on our ability to maintain and enforce patent protection for Chrysalin and each product resulting from Chrysalin |
| Without patent protection, other companies could offer substantially identical products for sale without incurring the sizable discovery, development and licensing costs that we have incurred |
| Our ability to recover these expenditures and realize profits upon the sale of products would then be diminished |
| Chrysalin is patented and there have been no successful challenges to the Chrysalin patent |
| However, if there were to be a challenge to the patent or any of the patents for product candidates, a court may determine that the patents are invalid or unenforceable |
| Even if the validity or enforceability of a patent is upheld by a court, a court may not prevent alleged infringement on the grounds that such activity is not covered by the patent claims |
| Any litigation, whether to enforce our rights to use our or our licensors’ patents or to defend against allegations that we infringe third party rights, will be costly, time consuming, and may distract management from other important tasks |
| As is commonplace in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at other biotechnology or pharmaceutical companies, including our competitors or potential competitors |
| To the extent our employees are involved in research areas which are similar to those areas in which they were involved at their former employers, we may be subject to claims that such employees and/or we have inadvertently or otherwise used or disclosed the alleged trade secrets or other proprietary information of the former employers |
| Litigation may be necessary to defend against such claims, which could result in substantial costs and be a distraction to management and which may have a material adverse effect on us, even if we are successful in defending such claims |
| We also rely in our business on trade secrets, know-how and other proprietary information |
| Nonetheless, we cannot assure that those agreements will provide adequate protection for our trade secrets, know-how or other proprietary information and prevent their unauthorized use or disclosure |
| To the extent that consultants, key employees or other third parties apply technological information independently developed by them or by others to our proposed products, 16 _________________________________________________________________ [49]Table of Contents disputes may arise as to the proprietary rights to such information, which may not be resolved in our favor |
| The risk that other parties may breach confidentiality agreements or that our trade secrets become known or independently discovered by competitors, could adversely affect us by enabling our competitors, who may have greater experience and financial resources, to copy or use our trade secrets and other proprietary information in the advancement of their products, methods or technologies |
| Our success also depends on our ability to operate and commercialize products without infringing on the patents or proprietary rights of others |
| Third parties may claim that we or our licensors or suppliers are infringing their patents or are misappropriating their proprietary information |
| In the event of a successful claim against us or our licensors or suppliers for infringement of the patents or proprietary rights of others, we may be required to, among other things: • pay substantial damages; • stop using our technologies; • stop certain research and development efforts; • develop non-infringing products or methods; and • obtain one or more licenses from third parties |
| A license required under any such patents or proprietary rights may not be available to us, or may not be available on acceptable terms |
| If we or our licensors or suppliers are sued for infringement, we could encounter substantial delays in, or be prohibited from, developing, manufacturing and commercializing our product candidates |
| Some of our product candidates are in early stages of development and may never be commercialized |
| Research, development and pre-clinical testing are long, expensive and uncertain processes |
| Other than indications for fracture repair and diabetic ulcer healing, none of our other Chrysalin product candidates has reached clinical trial testing |
| Our development of Chrysalin for the repair of cartilage defects, tendons and cardiovascular repair is currently in pre-clinical testing or the research stage |
| Our future success depends, in part, on our ability to complete pre-clinical development of these and other product candidates and advance them to the clinical trials |
| If we are unsuccessful in advancing our early stage product candidates into clinical testing for any reason, our business prospects will be harmed |
| Acquisition of New Class of Molecules, ICARMs™ On February 23, 2006 the Company entered into an agreement to purchase certain assets and assume certain liabilities of AzERx, Inc |
| for dlra390cmam000 in cash and the issuance of 1cmam355cmam000 shares of the Company’s common stock, with a market value of dlra7dtta7 million determined by the closing share price on the date the agreement was entered into |
| The transaction was completed (closed) on February 27, 2006 |
| Under the terms of the transaction, OrthoLogic acquired an exclusive license for the core intellectual property relating to AZX100, and will continue to develop the new class of compounds in the field of smooth muscle relaxation called Intracellular Actin Relaxing Molecules, or ICARMs™, based on the unique technology developed by AzERx |
| The acquisition provides the Company with a new technology platform that diversifies the portfolio, and may provide more than one potential product |
| AZX100 is currently being investigated for medically important and commercially significant applications such as the treatment of vasospasm associated with subarachnoid hemorrhage, prevention of keloid scarring, and the treatment of asthma |
| Preclinical and human in vitro studies have shown that this novel compound has the ability to relax smooth muscle in multiple tissue types |
| While the Company performed a reasonable level of due diligence on AZX100 and the rights acquired, there can be no assurances that the Company will recover the costs of its investment from the future development of AZX100 |
| 17 _________________________________________________________________ [50]Table of Contents The loss of our key management and scientific personnel may hinder our ability to execute our business plan |
| As a small company our success depends on the continuing contributions of our management team and scientific personnel, and maintaining relationships with the network of medical and academic centers in the United States that conduct our clinical trials |
| The resignation or retirement of senior management is a current risk that could materially negatively affect our business prospects |
| Reliance on Outside Suppliers and Consultants We rely on outside suppliers and consultants for the manufacture of Chrysalin and AZX100 and technical assistance in our research and development efforts |
| The inability of our suppliers to meet our production quality requirements in a timely manner, or the lack of availability of experienced consultants to assist in our research and development efforts, could have a material effect on our ability to perform research or clinical trials |
| We face an inherent risk of liability in the event that the use or misuse of our products results in personal injury or death |
| The use of our product candidates in clinical trials, and the sale of any approved products, may expose us to product liability claims, which could result in financial losses |
| Our clinical liability insurance coverage may not be sufficient to cover claims that may be made against us |
| In addition, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts or scope to protect us against losses |
| Any claims against us, regardless of their merit, could severely harm our financial condition, strain our management and other resources and adversely impact or eliminate the prospects for commercialization of the product which is the subject of any such claim |
| Additional authorized shares of our common stock and preferred stock available for issuance may have dilutive, anti-takeover and other material effects on our stockholders |
| We are authorized to issue 100cmam000cmam000 shares of common stock |
| As of December 31, 2005, there were 38cmam124cmam742 shares of common stock issued and outstanding |
| However, the total number of shares of our common stock issued and outstanding does not include shares reserved in anticipation of the exercise of options, warrants or additional investment rights |
| As of December 31, 2005, we had stock options outstanding to purchase approximately 3cmam040cmam785 shares of our common stock, the exercise price of which range between dlra2dtta43 per share to dlra17dtta38 per share, and we have reserved shares of our common stock for issuance in connection with the potential exercise thereof |
| In addition, in the event that any future financing or consideration for a future acquisition should be in the form of, be convertible into or exchangeable for, equity securities, investors will experience additional dilution |
| We also have 2cmam000cmam000 shares of authorized preferred stock, the terms of which may be fixed by our Board |
| We presently have no outstanding shares of preferred stock |
| While we have no present plans to issue any additional shares of preferred stock, our Board has the authority, without stockholder approval, to create and issue one or more series of such preferred stock and to determine the voting, dividend and other rights of holders of such preferred stock |
| The issuance of any of such series of preferred stock may have an adverse effect on the holders of common stock |
| In connection with the Rights Agreement dated as of March 4, 1997 between the Company and the Bank of New York, as amended (the “Rights Agreement”), our board approved the designation of 500cmam000 shares of Series A Preferred Stock |
| The Rights Agreement and the exercise of rights to purchase Series A Preferred Stock pursuant to the terms thereof may delay, defer or prevent a change in control because the terms of any issued Series A Preferred Stock would potentially prohibit our consummation of certain extraordinary corporate transactions without the approval of the Board |
| In addition to the anti-takeover effects of the rights granted under the Rights Agreement, the issuance of preferred stock, generally, could have a dilutive effect on our stockholders |
| 18 _________________________________________________________________ [51]Table of Contents Our stock price is volatile and fluctuates due to a variety of factors |
| Our stock price has varied significantly in the past (from a low of dlra2dtta93 to a high of dlra8dtta96 from January 1, 2004 to December 31, 2005) and may vary in the future due to a number of factors, including: • announcement of the results of, or delays in, preclinical and clinical studies; • fluctuations in our operating results; • developments in litigation to which we or a competitor is subject; • announcements and timing of potential acquisitions, divestitures, capital raising activities and conversions of preferred stock; • announcements of technological innovations or new products by us or our competitors; • FDA and other regulatory actions; • developments with respect to our or our competitors’ patents or proprietary rights; • public concern as to the safety of products developed by us or others; and • changes in stock market analyst recommendations regarding us, other drug development companies or the pharmaceutical industry generally |
| In addition, the stock market has from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies |
| These broad market fluctuations may adversely affect the market price of our stock |
| Our Chrysalin Product Platform is currently in the human testing phase for three potential products and earlier pre-clinical testing phases for two other potential products |
| The FDA and comparable agencies in many foreign countries impose substantial limitations on the introduction of new pharmaceuticals through costly and time-consuming laboratory and clinical testing and other procedures |
| The process of obtaining FDA and other required regulatory approvals is lengthy, expensive and uncertain |
| Chrysalin, as a new drug, is subject to the most stringent level of FDA review |
| Even after we have invested substantial funds in the development of our three Chrysalin products and even if the results of our current clinical trials are favorable, there can be no guarantee that the FDA will grant approval of Chrysalin for the indicated uses or that it will do so in a timely manner |
| If we successfully bring one or more products to market, there is no assurance that we will be able to successfully manufacture or market the products or that potential customers will buy them if, for example, a competitive product has greater efficacy or is deemed more cost effective |
| In addition, the market in which we will sell any such products is dominated by a number of large corporations that have vastly greater resources than we have, which may impact our ability to successfully market our products or maintain any technological advantage we might develop |
| We also would be subject to changes in 19 _________________________________________________________________ [52]Table of Contents regulations governing the manufacture and marketing of our products, which could increase our costs, reduce any competitive advantage we may have and/or adversely affect our marketing effectiveness |
| The results of our late stage clinical trials may be insufficient to obtain FDA approval, which could result in a substantial delay in our ability to generate revenue |
| Positive results from pre-clinical studies and early clinical trials do not ensure positive results in more advanced clinical trials |
| If we are unable to demonstrate that a product candidate will be safe and effective in advanced clinical trials involving larger numbers of patients, we will be unable to submit the NDA necessary to receive approval from the FDA to commercialize that product |
| We are currently conducting a Phase 2b and Phase 3 human clinical trial on Chrysalin for fracture repair indications |
| If we fail to achieve the primary endpoints in these clinical trials or the results are ambiguous, we will have to determine whether to redesign our Chrysalin fracture repair product candidate and our protocols and continue with additional testing, or cease activities in this area |
| Redesigning the product candidate could be extremely costly and time-consuming |
| A substantial delay in obtaining FDA approval or termination of the Chrysalin fracture repair product candidate could result in a delay in our ability to generate revenue |
| Patients may discontinue their participation in our clinical studies, which may negatively impact the results of these studies and extend the timeline for completion of our development programs |
| As with all clinical trials, we are subject to the risk that patients enrolled in our clinical studies may discontinue their participation at any time during the study as a result of a number of factors, including, withdrawing their consent or experiencing adverse clinical events, which may or may not be judged related to our product candidates under evaluation |
| We are subject to the risk that if a large number of patients in any one of our studies discontinue their participation in the study, the results from that study may not be positive or may not support an NDA for regulatory approval of our product candidates |
| In addition, the time required to complete clinical trials is dependent upon, among other factors, the rate of patient enrollment |
| Patient enrollment is a function of many factors, including: • the size of the patient population; • the nature of the clinical protocol requirements; • the diversion of patients to other trials or marketed therapies; • our ability to recruit and manage clinical centers and associated trials; • the proximity of patients to clinical sites; and • the patient eligibility criteria for the study |
| Even if we obtain marketing approval, our products will be subject to ongoing regulatory oversight, which may affect our ability to successfully commercialize any products we may develop |
| Even if we receive regulatory approval of a product candidate, the approval may be subject to limitations on the indicated uses for which the product is marketed or require costly post-marketing follow-up studies |
| After we obtain marketing approval for any product, the manufacturer and the manufacturing facilities for that product will be subject to continual review and periodic inspections by the FDA and other regulatory agencies |
| The subsequent discovery of previously unknown problems with the product, or with the manufacturer or facility, may result in restrictions on the product or manufacturer, including withdrawal of the product from the market |
| 20 _________________________________________________________________ [53]Table of Contents If we fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution |
| Our product candidates may not gain market acceptance among physicians, patients and the medical community, including insurance companies and other third party payors |
| If our product candidates fail to achieve market acceptance, our ability to generate revenue will be limited |
| Even if we obtain regulatory approval for our products, market acceptance will depend on our ability to demonstrate to physicians and patients the benefits of our products in terms of safety, efficacy, and convenience, ease of administration and cost effectiveness |
| In addition, we believe market acceptance depends on the effectiveness of our marketing strategy, the pricing of our products and the reimbursement policies of government and third-party payors |
| Physicians may not prescribe our products, and patients may determine, for any reason, that our product is not useful to them |
| Insurance companies and other third party payors may determine not to reimburse for the cost of the therapy |
| If any of our product candidates fails to achieve market acceptance, our ability to generate revenue will be limited |
| The pharmaceutical industry is subject to stringent regulation, and failure to obtain regulatory approval will prevent commercialization of our products |
| Our research, development, pre-clinical and clinical trial activities and the manufacture and marketing of any products that we may successfully develop are subject to an extensive regulatory approval process by the FDA and other regulatory agencies in the United States and abroad |
| The process of obtaining required regulatory approvals for drugs is lengthy, expensive and uncertain, and any such regulatory approvals may entail limitations on the indicated usage of a drug, which may reduce the drug’s market potential |
| In order to obtain FDA approval to commercialize any product candidate, an NDA must be submitted to the FDA demonstrating, among other things, that the product candidate is safe and effective for use in humans for each target indication |
| Our regulatory submissions may be delayed, or we may cancel plans to make submissions for product candidates for a number of reasons, including: • negative or ambiguous pre-clinical or clinical trial results; • changes in regulations or the adoption of new regulations; • unexpected technological developments; and • developments by our competitors that are more effective than our product candidates |
| Consequently, we cannot assure that we will make our submissions to the FDA in the timeframe that we have planned, or at all, or that our submissions will be approved by the FDA Even if regulatory clearance is obtained, post-market evaluation of our products, if required, could result in restrictions on a product’s marketing or withdrawal of a product from the market as well as possible civil and criminal sanctions |
| Clinical trials are subject to oversight by institutional review boards and the FDA to ensure compliance with the FDA’s good clinical practice regulations, as well as other requirements for good clinical practices |
| We depend, in part, on third-party laboratories and medical institutions to conduct pre-clinical studies and clinical trials for our products and other third-party organizations, usually universities, to perform data collection and analysis, all of which must maintain both good laboratory and good clinical practices |
| If any such standards are not complied with in our clinical trials, the FDA may suspend or terminate such trial, which would severely delay our development and possibly end the development of a product candidate |
| 21 _________________________________________________________________ [54]Table of Contents We also currently and in the future will depend upon third party manufacturers of our products, which are and will be required to comply with the applicable FDA Good Manufacturing Practice regulations |
| We cannot be certain that our present or future manufacturers and suppliers will comply with these regulations |
| The failure to comply with these regulations may result in restrictions in the sale of, or withdrawal of the products from the market |
| Compliance by third parties with these standards and practices are outside of our direct control |
| In addition, we are subject to regulation under state and federal laws, including requirements regarding occupational safety, laboratory practices, environmental protection and hazardous substance control, and may be subject to other local, state, federal and foreign regulation |
| We cannot predict the impact of such regulations on us, although they could impose significant restrictions on our business and require us to incur additional expenses to comply |
| If our competitors develop and market products that are more effective than ours, or obtain marketing approval before we do, our commercial opportunities will be reduced or eliminated |
| Competition in the pharmaceutical and biotechnology industries is intense and is expected to increase |
| Several biotechnology and pharmaceutical companies, as well as academic laboratories, universities and other research institutions, are involved in research and/or product development for various treatments for or involving fracture repair and diabetic ulcer healing |
| Many of our competitors have significantly greater research and development capabilities, experience in obtaining regulatory approvals and manufacturing, marketing, financial and managerial resources than we have |
| We are currently aware of the following development efforts by our competitors: • Acceleration of Fracture Repair: While there is currently no product approved by the FDA for acceleration of fracture repair, at least one large pharmaceutical company, Pfizer, Inc, is conducting human clinical trials in the United States for this indication |
| • Diabetic Ulcer Healing: To our knowledge, there are three corporate sponsored clinical trials underway on new drug substances for diabetic ulcer healing |
| These early stage clinical trials are being conducted by Genentech on recombinant human vascular endothelial growth factor, by King Pharmaceuticals on MRE0094, an adenosine A2A receptor agonist, and by Agennix on topical talactoferrin |
| Our competitors may succeed in developing products that are more effective than the ones we have under development or that render our proposed products or technologies noncompetitive or obsolete |
| In addition, certain of such competitors may achieve product commercialization before we do |
| If any of our competitors develops a product that is more effective than one we are developing or plan to develop, or is able to obtain FDA approval for commercialization before we do, we may not be able to achieve significant market acceptance for certain products of ours, which would have a material adverse effect on our business |
| Healthcare reform and restrictions on reimbursements may limit our financial returns |
| Our ability to successfully commercialize our products may depend in part on the extent to which government health administration authorities, private health insurers and other third party payors will reimburse consumers for the cost of these products |
| Third party payors are increasingly challenging both the need for, and the price of, novel therapeutic drugs and uncertainty exists as to the reimbursement status of newly approved therapeutics |
| Adequate third party reimbursement may not be available for our drug products to enable us to maintain price levels sufficient to realize an appropriate return on our investments in research and product development, which could restrict our ability to commercialize a particular drug candidate |
| 22 _________________________________________________________________ [55]Table of Contents We caution that the foregoing list of important factors is not exclusive |
| The foregoing list of important factors is not exclusive and may not be up to date |
| Developments in any of these areas, which are more fully described elsewhere in “Item 1 - Business,” and “Item 7 — Management’s Discussion and Analysis of Financial Condition and Results of Operations” could cause our results to differ materially from results that have been or may be projected by us |