Drug Manufacturers-Specialty & Generic

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OptiNose, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of products for patients treated by ear, nose, throat, and allergy specialists in the United States. The company offers XHANCE, a therapeutic product utilizing its proprietary exhalation delivery system (EDS) that delivers a topically acting corticosteroid for the treatment of chronic rhinosinusitis with nasal polyps, as well as is in Phase IIIb clinical trial for treatment of chronic sinusitis; and Onzetra Xsail, a powder EDS device. It has a license agreement with Currax Pharmaceuticals LLC for the commercialization of Onzetra Xsail. The company was founded in 2000 and is headquartered in Yardley, Pennsylvania. Address: 1020 Stony Hill Road, Yardley, PA, United States, 19067

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Organigram Holdings Inc., through its subsidiaries, engages in the production and sale of cannabis and cannabis-derived products in Canada. It offers medical cannabis products, including whole flower, milled flower, pre-rolls, infused pre-rolls, vapes, gummies, and concentrates for medical retailers; adult use recreational cannabis under the SHRED, Holy Mountain, Big Bag O' Buds, Monjour, Trailblazer, SHRED'ems, Edison Cannabis Co., Edison JOLTS, Tremblant, and Laurentian brands. The company also engages in the wholesale shipping of cannabis plant cuttings, dried flowers, blends, pre-rolls, and cannabis derivative-based products to retailers and wholesalers for adult-use recreational cannabis. It sells its products through online, as well as consumer channels. The company was incorporated in 2010 and is headquartered in Toronto, Canada. Address: 145 King Street West, Toronto, ON, Canada, M5H 1J8

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Neurocrine Biosciences, Inc. discovers, develops, and markets pharmaceuticals for neurological, neuroendocrine, and neuropsychiatric disorders in the United States and internationally. The company's products include INGREZZA for tardive dyskinesia and chorea associated with Huntington's disease; ALKINDI for adrenal insufficiency; Efmody capsules for classic congenital adrenal hyperplasia; Orilissa tablets for endometriosis; and Oriahnn capsules to treat uterine fibroids. Its product candidates in clinical development include valbenazine to treat dyskinetic cerebral palsy in pediatrics and adults; NBI-921352 to treat developmental and epileptic encephalopathy syndrome in pediatrics and adults; NBI-827104 to treat epileptic encephalopathy with continuous spike-and-wave during sleep; NBI-1076986 to treat movement disorders; crinecerfront to treat congenital adrenal hyperplasia in adults and children; EFMODY to treat congenital adrenal hyperplasia and adrenal insufficiency in adults; valbenazine for the adjunctive treatment of schizophrenia; NBI-1065845 for the treatment of inadequate response to treatment in major depressive disorder; luvadaxistat to treat cognitive impairment related to schizophrenia; NBI-1117568 for the treatment of schizophrenia; NBI-1070770 to treat major depressive disorder; NBI-1117570 for the treatment of symptoms of psychosis and cognition in neurological and neuropsychiatric conditions; and NBI-1117569, NBI-1117567, and NBI-1065890 to treat CNS indications. The company also has license and collaboration agreements with Heptares Therapeutics Limited; Takeda Pharmaceutical Company Limited; Idorsia Pharmaceuticals Ltd; Xenon Pharmaceuticals Inc.; Voyager Therapeutics, Inc.; BIAL " Portela & Ca, S.A.; Mitsubishi Tanabe Pharma Corporation; and AbbVie Inc. The company was incorporated in 1992 and is headquartered in San Diego, California. Address: 12780 El Camino Real, San Diego, CA, United States, 92130

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Lantheus Holdings, Inc. develops, manufactures, and commercializes diagnostic and therapeutic products that assist clinicians in the diagnosis and treatment of heart, cancer, and other diseases worldwide. It provides DEFINITY, an injectable ultrasound enhancing agent used in echocardiography exams; TechneLite, a technetium generator for nuclear medicine procedures; Xenon-133, a radiopharmaceutical gas to assess pulmonary function; Neurolite, an injectable imaging agent to identify the area within the brain where blood flow has been blocked or reduced due to stroke; Cardiolite, an injectable Tc-99m-labeled imaging agent to assess blood flow to the muscle of the heart; and PYLARIFY, an F 18-labelled PSMA-targeted PET imaging agent used for imaging of PSMA positive-lesions in men with prostate cancer. The company also offers Automated Bone Scan Index that calculates the disease burden of prostate cancer by detecting and classifying bone scan tracer uptakes as metastatic or benign lesions using an artificial neural network; RELISTOR for opioid-induced constipation; and aPROMISE, an artificial intelligence medical device software; and PYLARIFY AI, an AI-based medical device software to perform quantitative assessment of PSMA PET/CT images in prostate cancer. In addition, it develops 1095, a PSMA-targeted iodine-131-labeled small molecule; PNT2002, a radiopharmaceutical therapy to treat mCRPC; PNT2003, an SSTR therapy that treats patients with SSTR-positive neuroendocrine tumors; MK-6240, a F 18-labeled PET imaging agent that targets Tau tangles in Alzheimer's disease; LNTH-1363S, an fibroblast activation protein, alpha targeted, copper-64 labeled PET imaging agent; and flurpiridaz used to assess blood flow to the heart;. It has collaboration agreements with GE Healthcare; NanoMab Technology Limited; Curium; RefleXion Medical, Inc.; POINT; Regeneron Pharmaceuticals, Inc; and Ratio Therapeutics LLC. The company was founded in 1956 and is based in Bedford, Massachusetts. Address: 201 Burlington Road, Bedford, MA, United States, 01730

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Lifecore Biomedical, Inc., together with its subsidiaries, operates as an integrated contract development and manufacturing organization in the United States. The company engages in the manufacturing of injectable grade sodium hyaluronate (HA) in bulk form, as well as formulated and filled syringes and vials for injectable products used in treating a range of medical conditions and procedures. It also provides services, such as technology development, material component changes, analytical method development, formulation development, pilot studies, stability studies, process validation, and production of materials for clinical studies to its partners for HA-based and non-HA based aseptically formulated and filled products. The company was formerly known as Landec Corporation and changed its name to Lifecore Biomedical, Inc. in November 2022. Lifecore Biomedical, Inc. was founded in 1965 and is headquartered in Chaska, Minnesota. Address: 3515 Lyman Boulevard, Chaska, MN, United States, 55318

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Kiniksa Pharmaceuticals International, plc, a biopharmaceutical company, focuses on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical needs worldwide. Its product candidates include ARCALYST, an interleukin-1alpha and interleukin-1beta, for the treatment of recurrent pericarditis, which is an inflammatory cardiovascular disease; Mavrilimumab, a monoclonal antibody inhibitor that completed Phase II clinical trials for the treatment of giant cell arteritis; Vixarelimab, a monoclonal antibody, that is in Phase 2b clinical trial for the treatment of prurigo nodularis, a chronic inflammatory skin condition; and KPL-404, a monoclonal antibody inhibitor of the CD40- CD154 interaction, a T-cell co-stimulatory signal critical for B-cell maturation, immunoglobulin class switching, and type 1 immune response. The company was formerly known as Kiniksa Pharmaceuticals, Ltd and changed its name tpKiniksa Pharmaceuticals International, plc in June 2024. The company was incorporated in 2015 and is based in London, the United Kingdom. Address: 23 Old Bond Street, London, United Kingdom, WIS 4PZ

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Kamada Ltd. manufactures and sells plasma-derived protein therapeutics. Its commercial products include KAMRAB/KEDRAB for treating prophylaxis of rabies; CYTOGAM for Prophylaxis of Cytomegalovirus disease in kidney, lung, liver, pancreas, heart, and heart/lung transplants; VARIZIG for post exposure prophylaxis of varicella; WINRHO SDF for immune thrombocytopenic purpura and suppression of rhesus isoimmunization; HEPAGAM B for prevention of hepatitis B recurrence liver transplants and post-exposure prophylaxis; GLASSIA for intravenous AATD; KAMRHO (D) IM for prophylaxis of hemolytic disease of newborns; KAMRHO (D) IV for immune thermobocytopunic purpura; and Echis coloratus and Vipera palaestinae Antiserum for the treatment of snake bite. The company also distributes imported drug products in Israel, including BRAMITOB to manage chronic pulmonary infection; FOSTER to treat asthma; TRIMBOW for chronic obstructive pulmonary disease; PROVOCHOLINE for the diagnosis of bronchial airway hyperactivity; AEROBIKA, an OPEP device; RUPAFIN and RUPAFIN ORAL SOLUTION for allergic rhinitis and Urticaria; SINTREDIUS for rheumatoid arthritis, systemic lupus erythematosus, and mild-moderate juvenile dermatomyositis; IVIG for immunodeficiency-related conditions; VARITECT for chicken pox and zoster herpes; ZUTECTRA and HEPATECT CP for hepatitis B; MEGALOTECT CP for CMV virus; RUCONEST for angioedema attack; HEPARIN SODIUM INJECTION for thrombo-embolic disorders and prophylaxis of deep vein thrombosis and thromboembolic events; ALBUMIN and ALBUMIN for blood plasma; Factor VIII for hemophilia type A; and Factor IX for hemophilia type B. In addition, it distributes COAGADEX for hereditary factor X deficiency; IXIARO for Japanese encephalitis; VIVOTIF for Salmonella Typhi; PROCYSBI for nephropathic cystinosis; LAMZEDE for alpha-mannosidosis; ELIGARD for prostate cancer; and BEVACIZUMAB KAMADA for various cancers. The company was incorporated in 1990 and is headquartered in Rehovot, Israel. Address: 2 Holzman Street, Rehovot, Israel, 7670402

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Incannex Healthcare Inc., a clinical-stage biopharmaceutical company, engages in the research, development, manufacture, sale, and distribution of psychedelic medicines and therapies for patients with chronic diseases in Australia. The company develops IHL-42X, an oral fixed dose combination of dronabinol and acetazolamide that has completed Phase 2/3 clinical trial for the treatment of obstructive sleep apnea; and PSX-001, an oral synthetic psilocybin treatment in Phase 2b clinical development for patients with generalized anxiety disorder. It is also developing IHL-675A, an oral fixed dose combination drug containing synthetic cannabidiol and hydroxychloroquine sulphate in Phase 2 clinical trial to treat rheumatoid arthritis, as well as lung inflammation, acute respiratory disease, chronic obstructive pulmonary disease, asthma, bronchitis, inflammatory bowel disease, colitis, and Crohn's disease. Incannex Healthcare Inc. is headquartered in Sydney, Australia. Address: 8 Century Circuit, Sydney, NSW, Australia, 2153

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Intra-Cellular Therapies, Inc., a biopharmaceutical company, focuses on the discovery, clinical development, and commercialization of small molecule drugs that address medical needs primarily in neuropsychiatric and neurological disorders by targeting intracellular signaling mechanisms in the central nervous system (CNS) in the United States. The company offers CAPLYTA for the treatment of schizophrenia and bipolar depression in adults. It is also involved in developing Lumateperone, which is in Phase 3 clinical trial for the treatment of various depressive disorders, as well as additional neuropsychiatric indications. In addition, the company is developing Lenrispodun (ITI-214) for the treatment of Parkinson's disease, CNS, and other disorders; ITI-1284 for the treatment of neuropsychiatric disorders and behavioral disturbances in dementia; and ITI-333 for substance use disorders, pain, and psychiatric comorbidities, including depression, anxiety, and sleep disorders. Intra-Cellular Therapies, Inc. was founded in 2002 and is headquartered in New York, New York. Address: 430 East 29th Street, New York, NY, United States, 10016

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Ironwood Pharmaceuticals, Inc., a healthcare company, focuses on the development and commercialization of gastrointestinal (GI) products. It markets linaclotide, a guanylate cyclase type-C (GC-C) agonist for the treatment of adults suffering from irritable bowel syndrome with constipation or chronic idiopathic constipation under the LINZESS name in the United States, Mexico, Japan, Saudi Arabia, and China, as well as under the CONSTELLA name in the Canada and European countries. The company is also developing IW-3300, a GC-C agonist for the treatment of visceral pain conditions, including interstitial cystitis/bladder pain syndrome and endometriosis; Apraglutide, a next-generation, long-acting synthetic peptide analog of glucagon-like peptide-2, as a differentiated therapeutic for rare diseases, including short bowel syndrome dependent on parenteral support and acute graft versus host disease; and CNP-104, an immune nanoparticle for the treatment of primary biliary cholangitis. The company has strategic partnerships with AbbVie Inc., AstraZeneca AB, and Astellas Pharma Inc. for the development and commercialization of linaclotide. The company was formerly known as Microbia, Inc. and changed its name to Ironwood Pharmaceuticals, Inc. in April 2008. Ironwood Pharmaceuticals, Inc. was incorporated in 1998 and is headquartered in Boston, Massachusetts. Address: 100 Summer Street, Boston, MA, United States, 02110