Bristol-Myers Squibb Company (BMS) engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis.
The company expects that its planned acquisitions of Karuna, RayzeBio, and Mirati in 2024 will allow the company to expand in neuroscience and oncology, and continue to position us as a leading biopharmaceutical company across its core therapeutic areas.
The company’s principal strategy is to combine the resources,...
Bristol-Myers Squibb Company (BMS) engages in the discovery, development, licensing, manufacturing, marketing, distribution and sale of biopharmaceutical products on a global basis.
The company expects that its planned acquisitions of Karuna, RayzeBio, and Mirati in 2024 will allow the company to expand in neuroscience and oncology, and continue to position us as a leading biopharmaceutical company across its core therapeutic areas.
The company’s principal strategy is to combine the resources, scale and capability of a pharmaceutical company with the speed and focus on innovation of the biotech industry. The company’s focus as a biopharmaceutical company is on discovering, developing and delivering transformational medicines for patients facing serious diseases in areas where the company has an opportunity to make a meaningful difference: oncology, hematology, immunology, cardiovascular and neuroscience.
The company’s products are sold worldwide, primarily to wholesalers, distributors, specialty pharmacies, and to a lesser extent, directly to retailers, hospitals, clinics and government agencies. The company has significant manufacturing operations in the U.S., Puerto Rico, Switzerland, Ireland, and the Netherlands.
The company’s significant business development activities in 2024 included: the acquisition of Karuna, RayzeBio, and Mirati in addition to a global strategic collaboration agreement with SystImmune.
Products, Intellectual Property and Product Exclusivity
The company’s pharmaceutical products include chemically-synthesized or small molecule drugs, products produced from biological processes, called ‘biologics’, ADCs, chimeric antigen receptor (CAR-T) cell therapies, and radiopharmaceutical therapeutics. Small molecule drugs are typically administered orally in the form of a tablet or capsule, although other drug delivery mechanisms are used as well. Biologics are typically administered to patients through injections or by intravenous infusion. CAR-T therapies are administered to patients by intravenous infusion.
Below is a summary of the company’s significant products, including approved indications.
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Opdivo: Opdivo (nivolumab) is a biological product and a fully human monoclonal antibody that binds to the PD-1 on T and NKT cells. It has been approved for several anti-cancer indications, including bladder, blood, CRC, head and neck, RCC, HCC, lung, melanoma, MPM, stomach and esophageal cancer. The Opdivo+Yervoy regimen also is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and various gastric and esophageal cancers.
Opdivo Qvantig: Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) is a subcutaneously administered PD-1 inhibitor indicated for most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
Orencia: Orencia (abatacept) is a biological product, is a fusion protein indicated for adult patients with moderate to severe active RA and PsA and is also indicated for reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular JIA and for the treatment of aGVHD, in combination with a calcineurin inhibitor and methotrexate.
Yervoy: Yervoy (ipilimumab) is a biological product and is a CTLA4 immune checkpoint inhibitor. Yervoy is a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma. The Opdivo+Yervoy regimen is approved in multiple markets for the treatment of NSCLC, melanoma, MPM, RCC, CRC and esophageal cancer.
Reblozyl: Reblozyl (luspatercept-aamt) is a biological product, and is an erythroid maturation agent indicated for the treatment of anemia in adult patients with transfusion dependent and non-transfusion dependent beta thalassemia who require regular red blood cell transfusions; adult patients with very low- to intermediate-risk MDS who have ring sideroblasts and require red blood cell transfusions; and adult patients without previous erythropoiesis stimulating agent use (ESA-naïve) with very low- to intermediate-risk MDS who may require regular red blood cell transfusions, regardless of ring sideroblast status.
Opdualag: Opdualag (nivolumab and relatlimab-rmbw) is a combination of nivolumab, a PD-1 blocking antibody, and relatlimab, a LAG-3 blocking antibody, indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Breyanzi: Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous CAR-T cell therapy indicated for the treatment of adult patients with relapsed or refractory LBCL after one or more lines of systemic therapy, including DLBCL not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, grade 3B FL and relapsed or refractory FL after at least two prior lines of systemic therapy, relapsed or refractory CLL or SLL, and relapsed or refractory MCL in patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor and a B-cell lymphoma 2 inhibitor.
Camzyos: Camzyos (mavacamten) is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic obstructive HCM to improve functional capacity and symptoms.
Zeposia: Zeposia (ozanimod) is an oral immunomodulatory drug used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and to treat moderately to severely active UC in adults.
Abecma: Abecma (idecabtagene vicleucel) is a BCMA genetically modified autologous CAR–T cell therapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-cyclic ADP ribose hydrolase monoclonal antibody.
Sotyktu: Sotyktu (deucravacitinib) is an oral, selective, allosteric tyrosine kinase 2 inhibitor indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Krazati: Krazati (adagrasib) is a highly selective and potent oral small-molecule inhibitor of the KRASG12C mutation, indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy and, in combination with cetuximab, for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
Augtyro: Augtyro (repotrectinib) is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC and for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have NTRK gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
Cobenfy: Cobenfy (xanomeline and trospium chloride) is a combination M1/M4 muscarinic receptor agonist and muscarinic antagonist indicated for the treatment of schizophrenia in adults.
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Eliquis: Eliquis (apixaban) is an oral Factor Xa inhibitor indicated for the reduction in risk of stroke/systemic embolism in NVAF and for the treatment of DVT/PE and reduction in risk of recurrence following initial therapy.
Revlimid: Revlimid (lenalidomide) is an oral immunomodulatory drug that in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. Revlimid has received approvals for several indications in the hematological malignancies including lymphoma and MDS.
Pomalyst/Imnovid: Pomalyst/Imnovid (pomalidomide) is a small molecule that is administered orally and modulates the immune system and other biologically important targets. Pomalyst/Imnovid is indicated for patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Sprycel: Sprycel (dasatinib) is an oral inhibitor of multiple tyrosine kinase indicated for the first-line treatment of patients with Philadelphia chromosome-positive CML in chronic phase and the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior therapy, including Gleevec* (imatinib mesylate) and the treatment of children and adolescents aged 1 year to 18 years with chronic phase Philadelphia chromosome-positive CML.
Abraxane: Abraxane (paclitaxel albumin-bound particles for injectable suspension) is a solvent-free protein-bound chemotherapy product that combines paclitaxel with albumin using our proprietary Nab® technology platform, and is used to treat breast cancer, NSCLC and pancreatic cancer, among others.
The company owns or licenses a number of patents in the U.S. and foreign countries primarily covering the company’s products. The company has also developed many brand names and trademarks for its products. The company considers the overall protection of its patents, trademarks, licenses, and other intellectual property rights to be of material value and act to protect these rights from infringement.
The United States
In the U.S., most of the company’s key products are protected by patents with varying terms depending on the type of patent and the filing date.
A company seeking to market an innovative pharmaceutical in the U.S. must submit a complete set of safety and efficacy data to the FDA. If the innovative pharmaceutical is a chemical product, the company files an NDA. If the medicine is a biological product, a BLA is filed. Both types of applications can receive certain periods of regulatory exclusivity. An NDA or a BLA for a compound that is designated as an orphan drug can receive seven years of exclusivity for an orphan drug indication. During this period, the FDA generally may not approve another application for the same drug product for the same orphan use. A company may also earn six months of additional exclusivity for a drug where specific clinical studies are conducted at the written request of the FDA to study the use of the medicine to treat pediatric patients, and submission to the FDA is made prior to the loss of basic exclusivity. The type of application filed (NDA or BLA) can affect RDP exclusivity rights as discussed below.
Chemical Products
A competitor seeking to launch a generic substitute of a chemical innovative drug in the U.S. must file an ANDA with the FDA. In the ANDA, the generic manufacturer needs to demonstrate only ‘bioequivalence’ between the generic substitute and the approved NDA drug. The ANDA relies upon the safety and efficacy data previously filed by the innovator in its NDA.
ANDAs, including Paragraph IV certifications are filed with respect to certain of the company’s products. The company evaluates these ANDAs on a case-by-case basis and, where warranted, files suit against the generic manufacturer to protect the company’s patent rights.
Medicines approved under an NDA can also receive several types of RDP. An innovative chemical pharmaceutical product is entitled to five years of RDP in the U.S., during which the FDA cannot approve generic substitutes. If an innovator’s patent is challenged, as described above, a generic manufacturer may file its ANDA after the fourth year of the five-year RDP period. A pharmaceutical drug product that contains an active ingredient that has been previously approved in an NDA, but is approved in, for example, a new formulation or a new route of administration, but not for the drug itself, or for a new indication on the basis of new clinical studies, may receive three years of RDP for that formulation, route of administration, or indication. The company’s marketed chemical products include Eliquis, Pomalyst, Sprycel, Zeposia, Onureg, Inrebic, Camzyos, Sotyktu, and Augtyro (repotrectinib).
Biologic Products (includes CAR-T Cell Therapy Products)
The U.S. healthcare legislation enacted in 2010 created an approval pathway for biosimilar versions of innovative biological products. The FDA can approve products that are similar to (but not generic copies of) innovative biologics on the basis of less extensive data than is required by a full BLA. After an innovator has marketed its product for four years, any manufacturer may file an application for approval of a ‘biosimilar’ version of the innovator product. However, although an application for approval of a biosimilar version may be filed four years after approval of the innovator product, qualified innovative biological products will receive 12 years of RDP, meaning that the FDA may not approve a biosimilar version until 12 years after the innovative biological product was first approved by the FDA. The law also provides a mechanism for innovators to enforce the patents that protect innovative biological products and for biosimilar applicants to challenge the patents. Such patent litigation may begin as early as four years after the innovative biological product is first approved by the FDA. The company’s marketed biologic products include Opdivo, Orencia, Yervoy, Reblozyl, Abecma, Opdualag and Breyanzi.
European Union
Patents on pharmaceutical products are generally enforceable in the EU and, as in the U.S., may be extended to compensate for the patent term lost during the regulatory review process. Such extensions are granted on a country-by-country basis.
The primary route the company uses to obtain marketing authorization of pharmaceutical products in the EU is through the ‘centralized procedure.’ This procedure is compulsory for certain pharmaceutical products, in particular those using biotechnological processes, and is also available for certain new chemical compounds and products. A company seeking to market an innovative pharmaceutical product through the centralized procedure must file a complete set of safety data and efficacy data as part of an MAA with the EMA. After the EMA evaluates the MAA, it provides a recommendation to the EC and the EC then approves or denies the MAA. It is also possible for new chemical products to obtain marketing authorization in the EU through a ‘mutual recognition procedure,’ in which an application is made to a single member state, and if the member state approves the pharmaceutical product under a national procedure, then the applicant may submit that approval to the mutual recognition procedure of some or all other member states.
After obtaining marketing authorization approval, a company must obtain pricing and reimbursement for the pharmaceutical product, which is typically subject to member state law. In certain EU countries, this process can take place simultaneously while the product is marketed but in other EU countries, this process must be completed before the company can market the new product.
Throughout the EU, all products for which marketing authorizations have been filed after October and November 2005 are subject to an ‘8+2+1’ RDP regime. Eight years after the innovator has received its first community authorization for a medicinal product, a generic company may file a MAA for that product with the health authorities. If the MAA is approved, the generic company may not commercialize the product until after either 10 or 11 years have elapsed from the initial marketing authorization granted to the innovator. The possible extension to 11 years is available if the innovator, during the first eight years of the marketing authorization, obtains an additional indication that is of significant clinical benefit in comparison with existing treatments.
In contrast to the U.S., patents in the EU are not listed with regulatory authorities. Generic versions of pharmaceutical products can be approved after RDP expires, regardless of whether the innovator holds patents covering its drug. Thus, it is possible that an innovator may be seeking to enforce its patents against a generic competitor that is already marketing its product. Also, the European patent system has an opposition procedure in which generic manufacturers may challenge the validity of patents covering innovator products within nine months of grant.
Japan
In Japan, patents on pharmaceutical products are enforceable and may be extended to compensate for the patent term lost during the regulatory review process. Medicines of new chemical entities are generally afforded eight years of RDP for approved indications and dosage. Generic copies can receive regulatory approval after RDP and patent expirations.
Rest of the World
The company sells its pharmaceutical products in other countries, however, data is not provided on a country-by-country basis because individual country revenues are not significant outside the U.S., the EU and Japan.
Research and Development (R&D)
The company’s R&D expenses were $11.2 billion in 2024.
Marketing, Distribution and Customers
The company promotes the appropriate use of its products directly to healthcare professionals and organizations, such as doctors, nurse practitioners, physician assistants, pharmacists, technologists, hospitals, PBMs and Managed Care Organizations (‘MCOs’). The company also provides information about the appropriate use of its products to consumers in the U.S. through direct-to-consumer print, radio, television and digital advertising and promotion. In addition, the company sponsors general advertising to educate the public about the company’s innovative medical research and corporate mission.
Through the company’s field sales and medical organizations, the company explains the risks and benefits of the approved uses of its products to medical professionals. The company works to gain access for its products on formularies and reimbursement plans (lists of recommended or approved medicines and other products), including Medicare Part D plans, by providing information about the clinical profiles of the company’s products. The company’s marketing and sales of prescription pharmaceuticals is limited to the approved uses of the particular product, but the company continues to develop scientific data and other information about potential additional uses of the company’s products and provide such information as scientific exchange at scientific congresses or the company shares information about its products in other appropriate ways, including the development of publications, or in response to unsolicited inquiries from doctors, other medical professionals and MCOs.
The company’s operations include several marketing and sales organizations. Each product marketing organization is supported by a sales force, which is responsible for selling one or more products. The company also has marketing organizations that focus on certain classes of customers, such as managed care entities or certain types of marketing tools, such as digital or consumer communications. The company’s sales forces focus on communicating information about new approved products or uses, as well as approved uses of established products, and promotion to physicians is increasingly targeted at physician specialists who treat the patients in need of the company’s medicines.
The company’s products are sold principally to wholesalers, specialty distributors, specialty pharmacies, and to a lesser extent, directly to distributors, retailers, hospitals, clinics and government agencies. Revlimid and Pomalyst are distributed in the U.S. primarily through contracted pharmacies under the Lenalidomide Risk Evaluation and Mitigation Strategy (‘REMS’) (Revlimid) and Pomalyst REMS programs, respectively. These are proprietary, mandatory risk-management distribution programs tailored specifically to provide for the safe and appropriate distribution and use of Revlimid and Pomalyst. Internationally, Revlimid and Imnovid are distributed under mandatory risk-management distribution programs tailored to meet local authorities’ specifications to provide for the product’s safe and appropriate distribution and use. Camzyos is only available through the Camzyos REMS Program. Product distribution is limited to REMS certified pharmacies, and enrolled pharmacies must only dispense to patients who are authorized to receive Camzyos. These programs may vary by country and, depending upon the country and the design of the risk-management program, the product may be sold through hospitals or retail pharmacies.
The company’s U.S. business has DSAs with substantially all of its direct wholesaler and distributor customers that allow the company to monitor the U.S. wholesaler and distributor inventory levels and requires those wholesalers and distributors to maintain inventory levels that are no more than one month of their demand. The DSAs, including those with the company’s three largest wholesalers, expire in June 2024 subject to certain termination provisions.
The company’s non-U.S. businesses have significantly more direct customers. In a number of countries outside of the U.S., the company contracts with distributors to support certain products. The services provided by these distributors vary by market, but may include distribution and logistics; regulatory and pharmacovigilance; and/or sales, advertising or promotion.
Government Regulation
The Federal Food, Drug, and Cosmetic Act, other Federal statutes and regulations, various state statutes and regulations (including newly enacted state laws regulating drug price transparency, rebates and drug spending), and laws and regulations of foreign governments govern to varying degrees the testing, approval, production, labeling, distribution, post-market surveillance, advertising, dissemination of information and promotion of the company’s products.
The FDA periodically inspects the company’s drug manufacturing facilities to ensure compliance with applicable cGMP requirements. The company subscribes to the PhRMA Code and have implemented a compliance program to address the requirements set forth in the guidance and the company’s compliance with the healthcare laws.
The company is also subject to the jurisdiction of various other Federal and state regulatory and enforcement departments and agencies, such as the Federal Trade Commission, the Department of Justice and the Department of Health and Human Services in the U.S. The company is also licensed by the U.S. Drug Enforcement Administration to procure and produce controlled substances. The company is, therefore, subject to possible administrative and legal proceedings and actions by these organizations.
The company participates in state government Medicaid programs, as well as certain other qualifying Federal and state government programs whereby discounts and rebates are provided to participating state and local government entities. The company participates in the Medicaid Drug Rebate Program (‘MDRP’), under which the company must pay rebates to state Medicaid programs for the company’s covered outpatient drugs provided to Medicaid beneficiaries, with rebates based on pricing data the company reports regularly to the Centers for Medicare & Medicaid Services (CMS). The company also participates in the Health Resources and Services Administration's 340B program, under which the company must offer covered outpatient drugs to statutorily defined covered entities at no more than the 340B program ‘ceiling price’, with that price calculated based on MDRP-reported data. The company also participates in federal government programs that specify discounts to certain federal government entities; the most significant of which are the U.S. Department of Defense and the U.S. Department of Veterans Affairs.
Environmental Regulation
Many of the company’s facilities have been in operation for many years, and over time, the company and other operators of those facilities have generated, used, stored or disposed of substances or wastes that are considered hazardous under Federal, state and/or foreign environmental laws, including the U.S. Comprehensive Environmental Response, Compensation and Liability Act.
Foreign Operations
The company has significant operations outside the U.S. They are conducted both through the company’s subsidiaries and through distributors.
History
The company was founded in 1887. It was incorporated under the laws of the state of Delaware in 1933. The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989.
