ITEM 6. ITEM 7. ITEM 7A. ITEM 8. ITEM 9. ITEM 9A. ITEM 9B. ITEM Forest Laboratories, Inc. Our primary and most important products in the United States U. We emphasize detailing to physicians those branded ethical drug products which we believe have the most benefit to patients and potential for growth. We also focus on the development and introduction of new products, including products developed in collaboration with our licensing partners. Our products include those developed by us, those developed in conjunction with our partners and those acquired from other pharmaceutical companies and integrated into our marketing and distribution systems.
Except for the historical information contained herein, this report contains forward looking statements that involve a number of risks and uncertainties, including the difficulty of predicting U. No assurance can be made that any expectation, estimate or projection contained in a forward-looking statement will be achieved or will not be affected by the factors cited above or other future events. The Company undertakes no obligation to publicly revise forward-looking statements in light of subsequent events or developments, and given the risks and uncertainties associated with them, readers are cautioned not to place undue reliance upon them.
We sell our pharmaceutical products primarily to drug wholesalers and retailers, who distribute our products to hospitals, government agencies and other institutions. We market our products through our salesforces directly to physicians, pharmacies, hospitals, managed care and other healthcare organizations. Our salesforces consist of approximately 3, personnel, 3, domestic and international. Select products are sold elsewhere through independent distributors. The pharmaceutical industry is highly competitive as to the sale of products, research for new or improved products and the development and application of competitive drug formulation and delivery technologies.
There are numerous companies in the U. Many of our competitors in this industry have substantially greater financial resources than we do. We also face competition for the acquisition or licensing of new product opportunities from other companies. In addition, the marketing of pharmaceutical products is increasingly affected by the growing role of managed care organizations in the provision of health services. Such organizations negotiate with pharmaceutical manufacturers for highly competitive prices for pharmaceutical products in equivalent therapeutic categories, including certain of our principal promoted products.
Another competitive challenge we face is from generic pharmaceutical manufacturers. Upon the expiration or loss of patent protection for a product, we may lose a major portion of sales of such product in a very short period. Generic pharmaceutical manufacturers also challenge product patents before their expiry. Generic competitors operate without our large research and development expenses and our costs of conveying medical information about our novel products to the medical community. In addition, the FDA approval process generally exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy data of the innovator product.
This means that generic competitors can market a competing version of our product after the expiration or loss of our patent protection and charge much less for their product. In addition, many governments also encourage the use of generics as alternatives to brand-name drugs in their healthcare programs, including Medicaid.
Laws in the U. Actavis Merger. As a result of the Merger, we will become a wholly owned subsidiary of Actavis. The merger is expected to close during the second half of calendar Shares of our common stock with respect to which no election is made will receive the Mixed Election Consideration. Stockholders who make the Cash Election or the Stock Election will be subject to proration to ensure that the total amount of cash paid and the total number of Actavis shares issued to Forest shareholders as a whole are equal to the total amount of cash and number of Actavis shares that would have been paid and issued if all Forest shareholders received the Mixed Election consideration.
Business Combinations and Acquisitions of Product Rights. Aptalis , a privately-held U. Aptalis is an international, specialty pharmaceutical company that focuses on developing, manufacturing, licensing and marketing therapies for certain cystic fibrosis CF and gastro-intestinal GI related disorders.
Aptalis has manufacturing and commercial operations in the U. The pharmaceutical technologies business offers oral drug delivery platforms that provide advantages over existing formulations. Merck pursuant to which we purchased exclusive rights in the U.
The agreement also includes certain sales milestone payments to Merck upon the achievement of certain net sales thresholds. Through the acquisition of Furiex, a drug development collaboration company based in the U. IBS-d affects approximately 28 million patients in the U.
Eluxadoline and other products acquired will compliment and build on our GI therapeutic business. Key Commercial Products. The following is a summary of selected key products during the fiscal year ended March 31, Pursuant to the agreement, we assumed responsibility for the clinical development and commercialization of Fetzima in the U. Fetzima has been granted five years of Hatch-Waxman exclusivity that extends to Fetzima is protected by two U.
MDD is a serious medical condition requiring treatment, which affects almost 16 million adults in the U. Among all medical illnesses, MDD is a leading cause of disability in the U. The World Health Organization predicts depression will become the second leading cause of disability by the year Linzess was launched in December Linzess is an agonist of the guanylate cyclase type-C receptor found in the intestine and acts by a mechanism distinct from previously developed products for irritable bowel syndrome with constipation IBS-C and chronic idiopathic constipation CIC.
We and our partner Ironwood Pharmaceuticals, Inc. Under the terms of the agreement, we and Ironwood share equally all profits and losses from the development and commercialization of Linzess in the U. In addition, we obtained exclusive rights to the linaclotide license in Canada and Mexico, for which we will pay Ironwood royalties based on net sales.
We expect to launch the product in Canada in mid-calendar In September , we entered into an agreement with Almirall, S. Almirall whereby we sublicensed the rights to commercialize linaclotide in Mexico to Almirall. Almirall is expected to launch the product in Mexico in mid-calendar We will receive royalties based on sales of the product in Mexico, a portion of which will be due to Ironwood.
Linzess has been granted five years of Hatch-Waxman exclusivity that extends to Linzess is also protected by U. IBS-C is a chronic functional gastrointestinal disorder that affects 13 million people in the U. IBS-C can have an impact on daily living. There are currently few available therapies to treat this disorder. As many as 35 million Americans suffer from symptoms associated with CIC.
Patients with CIC often experience infrequent bowel movements less than three times per week for at least three months, a sensation of incomplete evacuation and hard stools. We and our partner Almirall, received FDA approval in July for Tudorza Pressair aclidinium bromide inhalation powder , a long-acting antimuscarinic agent, for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease COPD.
Tudorza is administered to patients using Pressair, a novel state-of-the-art multi-dose dry powder inhaler. It contains multiple doses of Tudorza, includes a visible dose-level indicator, and also incorporates safety features such as an anti-double dosing mechanism and an end-of-dose lock-out system to prevent use of an empty inhaler.
We licensed the exclusive U. We will be responsible for sales and marketing of Tudorza in the U. Tudorza has been granted five years of Hatch-Waxman exclusivity that extends to Tudorza is also protected by U. A request for PTE has been submitted to extend a composition-of-matter patent to In addition, there are four issued U. Over 12 million people in the U. We anticipate receiving a response from the FDA in the third quarter of calendar year We licensed the exclusive rights to develop and market Namenda in the U.
Namenda is protected by a U. Namenda XR is protected by a U. In addition, Namenda XR is protected by a U. We obtained exclusive worldwide rights to Viibryd through our acquisition of Clinical Data, Inc. Clinical Data which was completed in April Viibryd was launched in the U. Viibryd has been granted five years of Hatch-Waxman exclusivity that extends to Viibryd is also protected by a U.
A request for PTE has been submitted to extend the composition-of-matter patent to In addition, there are multiple issued U. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic adenosine monophosphate in lung cells. Daliresp is the first oral treatment for COPD patients to reduce the risk of exacerbations. Other treatments for COPD patients include the use of bronchodilators alone and in combination with inhaled corticosteroids.
Pursuant to our agreement with Nycomed we are obligated to pay Nycomed royalties on Daliresp sales. In addition to five years of Hatch-Waxman exclusivity that expires in , Daliresp is also protected by a U. In addition, Daliresp is protected by an issued formulation patent that expires in and multiple patents directed to methods-of-use and compositions that extend to We received marketing approval for Teflaro ceftaroline fosamil from the FDA in October for the treatment of adults with community-acquired bacterial pneumonia, including cases caused by Streptococcus pneumoniae and with acute bacterial skin and skin structure infections, including cases caused by methicillin-resistant Staphylococcus aureus MRSA.
Teflaro is a member of the cephalosporin class of antibiotics, the most frequently prescribed class of antibiotics in the world. In addition to five years of Hatch-Waxman exclusivity that extends to , Teflaro is covered by U. A request for PTE has been submitted in the U. In addition, Teflaro is protected by a composition patent that expires in Under the terms of the agreement AstraZeneca is obligated to pay us royalties based on sales of Teflaro. Like other beta-blockers, Bystolic decreases heart rate and myocardial contractility. We licensed exclusive U. Mylan licensed the U. In March , we entered into an agreement with Janssen, under which we acquired all U.
Bystolic was launched in Canada in April Bystolic is protected by a formulation patent that expires in and a pharmaceutical composition patent that expires in , with PTE.
Federal Trade Commission, we will provide licenses to these companies which will permit these companies to launch their generic versions of Bystolic as of the date that is the later of a three calendar months prior to the expiration of the U. Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function.
We licensed the U. Pursuant to our agreement, we are obligated to pay Cypress royalties based on net sales of Savella. In addition to five years of Hatch-Waxman exclusivity that expires in , Savella is protected by two method-of-use patents that expire in and a method-of-use patent that expires in In addition, Savella is protected by a U.
Saphris is a treatment for adult patients with schizophrenia and is used as monotherapy or adjunctive therapy, of manic or mixed episodes associated with bipolar I disorder. Saphris is an atypical antipsychotic approved by the FDA and launched in We purchased commercial rights to Saphris in the U.
Saphris has been granted five years of Hatch-Waxman exclusivity that expires in Saphris is protected by an issued U. Saphris is also protected by an issued U. Canasa was launched in February and is the only FDA-approved mesalamine suppository available in the U.
We obtained rights to Canasa through our acquisition of Aptalis and commenced sales of the product in February Canasa is protected by two U. Aptalis received letters from two parties indicating that they had each filed an ANDA seeking approval to market a generic version of Canasa. In July , Aptalis filed patent infringement suits against each party. Carafate is the only available sucralfate oral suspension product in the U. We obtained rights to Carafate through our acquisition of Aptalis and commenced sales of the product in February We obtained rights to Zenpep through our acquisition of Aptalis and commenced sales of the product in February Zenpep is covered by U.
Zenpep has been granted five years of Hatch-Waxman exclusivity until August We believe we are on track to meet these commitments. We obtained rights to Pylera through our acquisition of Aptalis and commenced sales of the product in February Pylera was approved by the FDA and was launched in the U. Pylera was launched in Germany in January and France in April We obtained rights to Salofalk through our acquisition of Aptalis and commenced sales of the product in February Colobreathe is a novel dry powder inhaler developed by Forest containing colistin, indicated for the treatment of chronic lung infections caused by Pseudomonas aeruginosa in CF patients aged 6 years and older.
This transaction and the approval to market Colobreathe in Europe enable us to expand our European CF franchise and become a major distributor of colistin in Europe. Health Canada granted approval for Bystolic in December and the product was launched in April This approval provides a new option for the up to 8. We plan to launch the product in Canada in June The PT business provides us with the opportunity to develop innovative products for our internal product pipeline and the flexibility to offer third-parties co-development programs, product out-licensing and manufacturing programs.
The agreement includes an exclusive license from Forest to moksha8 to commercialize Viibryd, and potentially other Forest products, in Latin America. Such debt financing has a term of seven years from the date of initial funding and is collateralized by the assets of moksha8. Drug Development and Research. The following is a summary of selected key development programs as of March 31, , including programs where an NDA has been submitted to the FDA:.
In addition, the combination is protected by an issued method-of-use patent related to the extended release formulation that expires in This FDC is protected by two issued U.
Avibactam is a novel broad-spectrum beta-lactamase inhibitor designed to be co-administered intravenously with select antibiotics to enhance their spectrum of activity by overcoming beta-lactamase-related antibacterial resistance. Avibactam is currently being developed in combination with ceftazidime, a cephalosporin antibiotic.
Under the terms of the agreement, we will be obligated to pay half of certain future milestones if development is successfully completed. Avibactam inhibits several classes of bacterial enzymes called beta-lactamases that break down and inactivate beta-lactam antibiotics in particular penicillins and cephalosporins making the pathogens producing these enzymes resistant to these antibiotics.
Beta-lactamase inhibition represents a mechanism for counteracting this resistance and enhancing the broad-spectrum activity of beta-lactam antibiotics. In addition, avibactam is protected by a U. Avibactam is also protected by an issued U. In November , we received a Complete Response Letter in which the FDA acknowledged that cariprazine demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder and requested further information on the drug, including additional clinical trial data to better define the optimal dosing regimen to maintain the demonstrated efficacy, while minimizing the potential for the development of adverse events generally associated with this class of drug.
The Company subsequently provided additional clinical trial data to the FDA and anticipates a resubmission by the end of calendar year In March , we announced positive topline results from a Phase IIb trial evaluating the efficacy and safety of cariprazine as adjunctive treatment in adult patients with MDD who have demonstrated an inadequate response to antidepressant therapy. Also in March , we announced positive topline results from a Phase IIb trial evaluating the efficacy and safety of Cariprazine as an investigational antipsychotic in patients with bipolar depression.
Cariprazine is licensed through a collaboration and license agreement with Gedeon Richter Plc. Richter , based in Budapest, Hungary. Our license grants us exclusive development and commercialization rights to Cariprazine and its related compounds in the U. We collaborate with Richter in product development and jointly fund such development activities. Under the terms of the agreement with Richter, we will be obligated to pay future milestone payments if development and commercialization are successfully completed. We will also be obligated to pay Richter a royalty based on net sales of the product.
In addition to five years of Hatch-Waxman exclusivity which we anticipate would be granted upon approval, cariprazine is protected by a U. Cariprazine is also protected by an issued U. FDC of aclidinium and formoterol: Pursuant to our licensing agreement with Almirall for Tudorza aclidinium , Almirall also granted us certain rights of first negotiation for other Almirall respiratory products involving combinations with aclidinium. Pursuant to such rights, we commenced the development of an FDC of aclidinium and the long acting beta-agonist formoterol for the treatment of COPD. Both doses of the FDC were well tolerated in the studies.
Under the terms of the agreement, we will be obligated to pay Almirall future milestone payments if development and commercialization are successfully completed for the FDC. In addition, we obtained co-promotion rights for aclidinium in Canada, for which we will pay Almirall royalties based on net sales, subject to receiving regulatory approval. In February , we and our partner Almirall filed a submission in Canada for the FDC of aclidinium and formoterol and anticipate feedback from Health Canada by the first quarter of calendar year Cebranopadol and GRT are novel first-in-class compounds with unique pharmacological and pharmacokinetic profiles that may enhance their effect in certain pain conditions.
The unique mode of action of these compounds builds on the ORL-1 receptor and, supported by the established mu opioid receptor, is particularly suitable for the treatment of moderate to severe chronic pain. Cebranopadol has successfully completed initial proof-of-concept studies in nociceptive and neuropathic pain with further Phase II studies planned prior to initiation of Phase III studies. We anticipate five years of Hatch-Waxman exclusivity upon approval.
Both compounds are protected by a U. Pursuant to the agreement, we have exclusive rights in the U. Zenpep franchise. Due to the increased stability of enzymes in this formulation and lack of overfill, we believe that Zenpep-EU provides a more predictable and precise dosage than other PEPs currently available in the EU and meets the EU guidance on development of CF products. We are seeking a marketing authorization in the EU under the centralized procedure.
We completed the Phase III program and we expect to file by the end of calendar year There is a pending European patent application with claims directed to the same subject matter as the U. Development Program Review: From time to time, we perform a review of all developmental projects and re-evaluate our development priorities based on the regulatory and commercial prospects of the products in development. We consider the commercial potential of the products as well as the development and commercialization costs necessary to achieve approval and successful launch.
In certain situations we may discontinue a development program based on this review. Pursuant to this agreement, we conducted in collaboration with Nabriva, certain development activities related to BC During the first quarter of fiscal , we discontinued our collaborative development with Nabriva after a review of this development program.
As a result of this review, in light of development priorities, we made the decision to terminate the partnership with TransTech. Senior Management. Saunders to succeed Mr. Immediately prior to his appointment as President and Chief Executive Officer, he resigned from both committees, effective as of September 9, Debt Issuance. The 5. Project Rejuvenate is focused on three areas: flattening and broadening the organization to reduce layers and increase spans of control, increase our productivity and profitability by decreasing costs and streamlining work to reduce low value activities.
The Company began the integration of Aptalis after completion of the acquisition in February and the integration is currently on-going. Share Repurchase Program. On May 18, , our Board of Directors authorized the Share Repurchase Program for up to 50 million shares of common stock of which The new authorization became effective immediately and has no set expiration date. Sales Concentration. Namenda IR. Namenda is marketed under agreements between Forest and Merz dated June 28, collectively, the Merz License.
A copy of the Merz License has been filed as Exhibit Under the terms of the Merz License, we were granted exclusive U. The Merz License requires that Forest pay to Merz a percentage of its net revenues from the sale of Namenda as a royalty. The agreement expires in On February 14, , we announced plans to discontinue the production and sale of Namenda IR effective August 15, in order to focus resources and sales efforts for Namenda XR.
The agreement may be terminated by either party in the event the other party breaches any of its obligations under the agreement and such breach continues beyond any applicable cure period as determined by an arbitration proceeding. In the event of such a termination by Merz, Forest would lose all of its rights under the agreement. Upon expiration of the agreement or upon earlier termination of the agreement by reason of a breach by Merz , Forest would continue to have a perpetual but non-exclusive license to market the product in the U.
Prior to March 30, , Bystolic was marketed under a sublicense agreement between Forest and Mylan Inc. Mylan , which in turn licensed rights to Bystolic from Janssen Pharmaceutical N. A copy of the Janssen sale and transfer agreement has been filed as Exhibit Lexapro was developed and is marketed under agreements with H. The Lexapro license agreement and related license and supply agreement have been filed as Exhibits Government Regulation.
The pharmaceutical industry is subject to comprehensive government regulation which substantially increases the difficulty and cost incurred in obtaining the approval to market newly proposed drug products and maintaining the approval to market existing drugs. In the U. The FDA regulates all aspects of the testing, manufacture, safety, labeling, storage, record keeping, advertising and promotion of new and established drugs, including the monitoring of compliance with good manufacturing practice regulations.
Non-compliance with applicable requirements can result in fines and other sanctions, including the initiation of product seizures, injunction actions and criminal prosecutions based on practices that violate statutory requirements. In addition, administrative remedies can involve voluntary recall of products as well as the withdrawal of approval of products in accordance with due process procedures.
Failure of the Company or any of its vendors or suppliers to comply with Current Good Manufacturing Practices and other applicable regulations and quality assurance guidelines could lead to manufacturing shutdowns, product shortages and delays in product manufacturing. Similar regulations exist in most foreign countries in which our products are manufactured or sold. In many foreign countries, such as the United Kingdom, reimbursement under national health insurance programs frequently require that manufacturers and sellers of pharmaceutical products obtain government approval of initial prices and increases if the ultimate consumer is to be eligible for reimbursement for the cost of such products.
The stated goals of this legislation include reducing the number of uninsured Americans, improving the quality of healthcare delivery and reducing projected healthcare costs. Many of the strategies included in this law have impacted manufacturers of branded pharmaceutical products. During the past several years, the FDA, in accordance with its standard practice, has conducted a number of inspections of our manufacturing facilities, our development facilities, our contracted investigator sites and our contract research organizations.
The cost of human healthcare products continues to be a subject of investigation and action by governmental agencies, legislative bodies and private organizations in the U. Federal and state governments continue to press efforts to reduce costs of Medicare and Medicaid programs, including restrictions on amounts agencies will reimburse for the use of products. In addition, several states have adopted prescription drug benefit programs which supplement Medicaid programs and are seeking discounts or rebates from pharmaceutical manufacturers to subsidize such programs.
Under the Omnibus Budget Reconciliation Act of OBRA , manufacturers must pay certain statutorily-prescribed rebates on Medicaid purchases for reimbursement of prescription drugs under state Medicaid plans. Federal Medicaid reimbursement for drug products of original NDA-holders is denied if less expensive generic versions are available from other manufacturers.
In addition, the Federal government follows a diagnosis-related group DRG payment system for certain institutional services provided under Medicare or Medicaid. The DRG system entitles a healthcare facility to a fixed reimbursement based on discharge diagnoses rather than actual costs incurred in patient treatment, thereby increasing the incentive for the facility to limit or control expenditures for many healthcare products.
A prescription-drug benefit for Medicare beneficiaries was established pursuant to the Medicare Prescription Drug, Improvement and Modernization Act of Under the program, pharmaceutical benefit managers and health programs offer discounted prices on prescription drugs to qualified Medicare recipients reflecting discounts negotiated with manufacturers where applicable. In April , the Federal Office of the Inspector General published guidance for pharmaceutical manufacturers with respect to compliance programs to assure manufacturer compliance with federal laws and programs relating to healthcare.
In addition, several states have adopted laws and regulations requiring certain specific disclosures with respect to our compliance program and our practices relating to interactions with physicians and other healthcare providers. We maintain a company-wide compliance program to assure compliance with applicable laws and regulations, as well as the standards of professional bodies governing interactions between pharmaceutical manufacturers and physicians, and believe we are in compliance with all legal requirements and standards.
The Sunshine Act requires manufacturers of pharmaceutical products to report annually to the Secretary of the Department of Health and Human Services all payments or transfers of value made by an entity or party on behalf of the respective entity to physicians, teaching hospitals, and third-parties on behalf of physicians or teaching hospitals. This final rule which required data collection on all payments and transfers of value took effect on August 1, The Company is current on all required submissions of information related to the Sunshine Act.
In connection with the finalization of a previously reported settlement resolving all aspects of the investigations led by the U. The CIA requires us to maintain our current compliance program and to undertake a set of defined corporate integrity obligations for a period of five years. The CIA also provides for an independent third-party review organization to assess and report on our compliance program.
Failure to comply with the terms of the CIA could result in substantial penalties and potential exclusion from government health care programs. Principal Customers. The following sets forth information with respect to the percentage of net sales accounted for by our principal customers:. McKesson Drug Company. AmerisourceBergen Corporation. Cardinal Health, Inc. Financial Information about Segments and Geographic Area. The Company and its subsidiaries, which are primarily located in the U. Environmental Standards.
We anticipate that the effects of compliance with federal, state and local laws and regulations relating to the discharge of materials into the environment will not have any material effect on our capital expenditures, earnings or competitive position. Raw Materials.
The active pharmaceutical ingredients in our principal promoted products, including Namenda IR, Namenda XR, Bystolic, Viibryd, Linzess, Daliresp, Savella Tudorza, Teflaro, and Fetzima, as well as our newly acquired Aptalis products and Saphris, are patented or otherwise generally available to us only pursuant to contractual arrangements with our licensing partners.
Other raw materials used by us are purchased in the open market. We have not experienced any significant shortage in supplies of active pharmaceutical ingredients or other raw materials. Product Liability Insurance. Although in the past there have been product liability claims asserted against us, none for which we have been found liable, there can be no assurance that all potential claims which may be asserted against us in the future would be covered by our present insurance.
At March 31, , we employed approximately 6, employees. Patents and Trademarks. Forest seeks to obtain, where possible, patents and trademarks for our products in the U. We own or have licenses to a substantial number of patents and patent applications. We believe that patents, licenses and trademarks or related groups of patents, licenses, or trademarks covering our marketed products are material in relation to our business as a whole.
Product Name. Approved Indication. Date of Last U. Namenda XR. Treatment of hypertension. Treatment of adults with MDD. Treatment to reduce the risk of COPD. Treatment of fibromyalgia. Treatment of bronchospasm. Treatment of adults with community-acquired bacterial pneumonia. Treatment of schizophrenia. Treatment of mild to moderately active ulcerative proctitis. Treatment of EPI. Treatment of H. When a product patent expires, the patent holder often loses effective market exclusivity for the product.
This can result in a severe and rapid decline in sales of the formerly patented product, particularly in the U. However, in some cases the innovator company may achieve exclusivity beyond the expiry of the product patent through manufacturing trade secrets, later-expiring patents on methods of use or formulations, or data-based exclusivity that may be available under pharmaceutical regulatory laws.
We own or exclusively license various trademarks and trade names which we believe are of significant benefit to our business.
Backlog - Seasonality. Backlog of orders is not considered material to our business prospects. Our business is not seasonal in nature. Table of Contents. Item 1A. Risk Factors. We operate in an industry which involves a number of significant risks, some of which are beyond our control. The following discussion highlights some of these risks and others are discussed elsewhere in this Form K. The risks discussed herein and other risks could have a material adverse effect on our business, prospects, results of operations, financial condition and cash flows. Additional risks not currently known to us or that we presently deem immaterial may also impair our business operations.
You should carefully consider all of the information set forth in this Form K, including the following risk factors, before making an investment decision with respect to our securities. This Form K also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements as a result of certain factors, including the risks we face as described below and elsewhere.
Risks Related to the Actavis Merger. As a result of the Actavis Merger, we will become a wholly owned subsidiary of Actavis. Stockholders who make the Cash Election or the Stock Election will be subject to proration to ensure that the total amount of cash paid and the total number of Actavis shares issued to Company stockholders as a whole are equal to the total amount of cash and number of Actavis shares that would have been paid and issued if all Company stockholders received the Mixed Election consideration. The following discussion highlights some of the potential risks that may arise in connection with the Actavis Merger.
Because the market price of Actavis ordinary shares will fluctuate, Company stockholders cannot be sure of the market price of the Actavis ordinary shares they will receive. As a result of the Actavis Merger, each issued and outstanding share of Company common stock, other than excluded shares and dissenting shares, will be converted into the right to receive the Standard Election Consideration.
Alternatively, Company stockholders will have the right to make either a cash election to receive the Cash Election Consideration, or a stock election to receive the Stock Election Consideration, for each of their Company shares. The market price of Actavis ordinary shares, which Company stockholders may receive in the Actavis Merger, will continue to fluctuate from the date of this Form K through the date of the closing of the Actavis Merger.
Dividends paid in respect of Actavis ordinary shares that are owned by a U. Under the terms of the agreement, we will be obligated to pay Almirall future milestone payments if development and commercialization are successfully completed for the FDC. Pharmacy names, logos, brands, and other trademarks are the property of their respective owners. Any such differences of opinion, as well as disputes or conflicting corporate priorities, could be a source of delay or uncertainty as to the expected benefits of the alliance or result in expensive arbitration or litigation, which may not be resolved in our favor. Namenda may make you dizzy.
Accordingly, at the time of the Company special meeting that will be conducted to consider the Actavis Merger, Company stockholders will not know or be able to determine the market price of the Actavis ordinary shares they may receive upon completion of the Actavis Merger. It is possible that, at the time of the closing of the Actavis Merger, the shares of Company common stock held by Company stockholders may have a greater market value than the cash and the Actavis ordinary shares for which they are exchanged.
The market price of Actavis ordinary shares on the date of the Company special meeting may not be indicative of the market price of Actavis ordinary shares that Company stockholders will receive upon completion of the Actavis Merger. The market prices of Actavis ordinary shares and Company common stock are subject to general price fluctuations in the market for publicly traded equity securities and have experienced volatility in the past. Stock price changes may result from a variety of factors, including general market and economic conditions and changes in the respective businesses, operations and prospects, and regulatory considerations of Actavis and the Company.
Market assessments of the benefits of the Actavis Merger and the likelihood that the Actavis Merger will be completed, as well as general and industry specific market and economic conditions, may also impact market prices of Actavis ordinary shares and Company common stock. You should obtain current market quotations for shares of Company common stock and for Actavis ordinary shares.
Company stockholders may receive a form of consideration different from what they elect. Although each Company stockholder may elect to receive all cash or all Actavis ordinary shares in the Actavis Merger, the pool of cash and the Actavis ordinary shares available for all Company stockholders will be a fixed percentage of the aggregate Merger Consideration at closing, and will not exceed the aggregate number of Actavis ordinary shares that would have been issued, and the aggregate amount of cash that would have been paid, to all of the holders of shares of Company common stock had the election to receive 0.
As a result, if the aggregate amount of shares with respect to which either cash elections or stock elections have been made would otherwise result in payments of cash or stock in excess of the maximum amount of cash or stock available, and a Company stockholder has chosen the consideration election that exceeds the maximum available, such Company stockholder will receive consideration in part in a form that such stockholder did not choose. This could result in, among other things, tax consequences that differ from those that would have resulted if such Company stockholder had received the form of consideration that the stockholder elected including the potential recognition of gain for federal income tax purposes if the stockholder receives cash.
The market price for Actavis ordinary shares following the closing may be affected by factors different from those that historically have affected Company common stock and Actavis ordinary shares. Upon completion of the Actavis Merger, holders of shares of Company common stock other than those who elect to receive all cash, and who do receive all cash, in the Actavis Merger, and the holders of excluded shares and dissenting shares will become holders of Actavis ordinary shares.
In addition, upon completion of the Actavis Merger, holders of Actavis ordinary shares will become holders of shares in the combined company. The results of operation of the combined company may also be affected by factors different from those currently affecting Actavis. The Actavis Merger is subject to customary closing conditions. These closing conditions include, among others, the receipt of required approvals by the Company stockholders and the Actavis shareholders, the clearances of the Actavis Merger by certain governmental and regulatory authorities and the expiration or termination of applicable waiting periods under the HSR Act, and the antitrust and competition laws of certain foreign countries under which filings or approvals are or may be required.
To the extent required, foreign investment filings will be made, though these are not closing conditions. The governmental agencies from which the parties will make these filings and seek certain of these approvals and consents have broad discretion in administering the governing regulations. Actavis and the Company can provide no assurance that all required approvals and consents will be obtained. Moreover, as a condition to their approval of the transaction, agencies may impose requirements, limitations or costs or require divestitures or place restrictions on the conduct of the business of the combined company after the closing.
These requirements, limitations, costs, divestitures or restrictions could jeopardize or delay the effective time or reduce the anticipated benefits of the transaction. Further, no assurance can be given that the required shareholder and stockholder approvals will be obtained or that the required closing conditions will be satisfied, and, if all required consents and approvals are obtained and the closing conditions are satisfied, no assurance can be given as to the terms, conditions and timing of the approvals or clearances.
This could result in a failure to consummate the transactions or have a material adverse effect on the business and results of operations of the combined company. The Merger Agreement may be terminated in accordance with its terms and the Actavis Merger may not be completed.
The Merger Agreement contains a number of conditions that must be fulfilled to complete the Actavis Merger. Those conditions include: the approval of the Actavis Merger by Company stockholders, approval of the Actavis Share Issuance Proposal by Actavis shareholders, receipt of requisite regulatory and antitrust approvals, absence of orders prohibiting completion of the Actavis Merger, effectiveness of the registration statement of which this document is a part, approval of the Actavis ordinary shares to be issued to Company stockholders for listing on the New York Stock Exchange, the continued accuracy of the representations and warranties of both parties subject to specified materiality standards, and the performance by both parties of their covenants and agreements.
These conditions to the closing of the Actavis Merger may not be fulfilled and, accordingly, the Actavis Merger may not be completed. In addition, Actavis or the Company may elect to terminate the Merger Agreement in certain other circumstances, and the parties can mutually decide to terminate the Merger Agreement at any time prior to the consummation of the Actavis Merger, before or after stockholder approval.
Under the Merger Agreement, the Company is restricted, subject to certain exceptions, from soliciting, initiating, knowingly encouraging, discussing or negotiating, or furnishing information with regard to, any inquiry, proposal or offer for a competing acquisition proposal from any person or entity.
The Company may not terminate the Merger Agreement in order to enter into an agreement with respect to a superior proposal. These provisions could discourage a third party that may have an interest in acquiring all or a significant part of the Company from considering or proposing that acquisition, even if such third party were prepared to enter into a transaction that would be more favorable to the Company and its stockholders than the Actavis Merger.
While the Actavis Merger is pending, Actavis and the Company will be subject to business uncertainties that could adversely affect their business. Uncertainty about the effect of the Actavis Merger on employees, customers and suppliers may have an adverse effect on the Company and Actavis. Employee retention may be challenging during the pendency of the Actavis Merger, as certain employees may experience uncertainty about their future roles.
If key employees depart because of issues related to the uncertainty and difficulty of integration or a desire not to remain with the businesses, the business of the combined company following the Actavis Merger could be seriously harmed. In addition, the Merger Agreement restricts the Company and, to a lesser extent, Actavis, from taking specified actions until the Actavis Merger occurs without the consent of the other party. These restrictions may prevent Actavis or the Company from pursuing attractive business opportunities that may arise prior to the completion of the Actavis Merger.
Company directors and officers may have interests in the Actavis Merger different from the interests of Company stockholders and Actavis shareholders. These directors and executive officers may have interests in the Actavis Merger that are different from, or in addition to, those of Company stockholders and Actavis shareholders. These interests include, but are not limited to, the continued employment of certain executive officers of the Company by Actavis, the continued service of certain directors of the Company as directors of Actavis, the treatment in the Actavis Merger of stock options, restricted stock, restricted stock units, bonus awards, change of control employment agreements and other rights held by Company directors and executive officers, and the indemnification of former Company directors and officers by Actavis.
Company stockholders will have a reduced ownership and voting interest after the Actavis Merger and will exercise less influence over management. For additional Namenda XR manufacturer coupons, rebate and savings, check our site often. Other coupons related to: Mental Health. You will get your card in the mail within two weeks.
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