OPKO Health Inc - Company Profile
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Business Description
OPKO Health Inc (OPKO) discovers, develops, and commercializes therapeutics and diagnostic products. The products include molecular diagnostics tests, point-of-care tests, and proprietary pharmaceuticals and vaccines among others. The company’s proprietary technologies include Carboxyl Terminal Peptide (CTP) technology, reversible PEGylation technology, and AntagoNAT technology.
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R&D Overview
The company’s R&D activities focus on developing novel solutions including biologics and others with focus on nephrology, endocrinology, urology, and rare diseases. The company’s proprietary technologies include Carboxyl-Terminal Peptide (CTP) technology, reversible PEGylation technology and AntagoNAT technology. Its CTP uses a recombinant technology to combine 28 amino acid sequence to a pharmacologically active protein, slower the excretion of therapeutic and helps in extending half-life of proteins. The company is currently using its CTP technology for the treatment of growth hormone deficiency and in its Factor VIIa product for haemophilia A & B management. OPKO harness its reversible PEGylation technology for creating extended-release therapeutics. Its reversible PEGylation technology through a proprietary bi-functional hydrolyzable linker forms a conjugate between a drug that contains a primary peptide and a polyethylene glycol (PEG) chain. Its Antisense Transcripts Antagonist (AntagoNAT) technology designs oligonucleotide molecule to interfere with regulatory gene expression and helps in enhancing the production of endogenous functional proteins. The company’s AntagoNAT platform is used to discover new drug that targets relevant genes that regulate the optimal production of endogenous functional proteins. It is using its AntagoNAT technology in OPK88001 for the treatment of dravet syndrome. As of December 31, 2021, the company operates R&D facilities in Kiryat Gat, Israel; Woburn, Massachusetts, the US; and Barcelona, Spain. The company owns various patents for Rayaldee (calcifediol) through EirGen Pharma Ltd; 4KScore and Claros1 PSA Test. It has manufacturing sites in Guadalajara, Mexico; Nesher, Israel; Banyoles, Spain; and Waterford, Ireland; main laboratory in Elmwood Park, New Jersey; API manufacturing site in Nesher, Israel; and a genetics laboratory in Gaithersburg, Maryland. In FY2022, OPKO spent US$73.9 million on its R&D activities accounted for 7.4% of company’s total revenue.
Business Segments
Overview
Operates diagnostics segment through its subsidiaries, BioReference Laboratories Inc and OPKO Diagnostic LLC. Offers diagnostics tests that includes prostate cancer test - 4Kscore test, molecular diagnostic test and point of care diagnostics. Provides laboratory testing services to healthcare providers used for detection, diagnosis, evaluation, monitoring, and treatment of various diseases including molecular diagnostics, anatomical pathology, esoteric testing, genetics, women’s health and correctional healthcare. Itx also offers COVID-19 screening programs including PCR COVID-19 testing and point of care testing. OPKO’s BioReference laboratory operates in four laboratory divisions namely, BioReference Laboratories, a clinical testing laboratory that offers automated, STAT testing, high volume routine testing services, informatics, HIV, Hep C and other molecular tests; GeneDx, a laboratory for testing rare and ultra-rare genetic diseases; GenPath (women’s health), a technology platform for sexually transmitted infections; and GenPath (oncology) offers tests including FLOW, IHC, MicroArray, FISH, ISH, Morphology for cancer pathology and molecular diagnostics. Through its subsidiary, OPKO Diagnostics, the company offers the Claros Analyzer, a novel diagnostic instrument system used to provide blood test results in the point-of-care setting. The company continues to leverage the BioReference commercial infrastructure and capabilities, and its extensive relationships with payers, to commercialize OPKO’s other diagnostic products under development. The company offers the 4Kscore test, a laboratory test that measures blood serum or plasma levels. This test provides plasma levels of 4 different proteins named Total PSA, Free PSA, Intact PSA, and Human Kallikrein-2.
Performance
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Overview
Markets Rayaldee (calcifediol), an extended-release capsule for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. Advancing pipeline products including Alpharen (fermagate tablet), a non-absorbed phosphate binder in Phase II clinical trials. It indicated for the treatment of hyperphosphatemia in stage 5 CKD patients who require regular haemodialysis; Rayaldee in Phase II trials. Rayaldee indicated for the treatment of SHPT in adults with stage 5 CKD; OPK88004, an orally administered selective androgen receptor modulator (SARM) in Phase I trials indicated for benign prostatic hypertrophy treatment; OPK88003 (Oxyntomodulin), a once-weekly administered peptide in Phase II indicated for the treatment of type 2 diabetes and obesity; OPK88005(Factor VIIa-CTP), a factor VIIa-CTP in Phase II for haemophilia; hGH-CTP (somatrogon), a recombinant human growth hormone product. This product is in Phase III trials indicated for the treatment of growth hormone deficiency. It is also developing a pipeline in the preclinical phase using its CTP technology. The company’s preclinical pipeline products include OPK88001 (AntagoNAT) for dravet syndrome; MOD-15014 (GLP-2) for short bowel syndrome; MOD-12014 (CTP-hGH antagonist) for acromegaly; and MOD-13012 (CTP-IGF-1) for severe primary insulin-like growth factor 1 (IGF-1) deficiency (SPIGFD). Revenue from transfer of intellectual property and other has been included in this segment. Conducts pharmaceutical operations in Mexico, Ireland, Chile, Israel and Spain.
Performance
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Geographical Segments
Performance
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Performance
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Performance
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Performance
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Performance
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Performance
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Performance
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