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	1	+US:ARDX

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5	5	= Company overview =
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7		-Ardelyx is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. The company's primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia; patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. Ardelyx has also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.
	7	+Ardelyx (ARDX) is a specialized biopharmaceutical company focused on developing first-in-class, disruptive medicines for the treatment of renal diseases. The company's primary therapeutic focus is on treating people with renal diseases, which affect both the heart and the kidneys. This includes patients with end-stage renal disease, or ESRD, who suffer from elevated serum phosphorus, or hyperphosphatemia; patients with chronic kidney disease, or CKD, and/or heart failure patients with elevated serum potassium, or hyperkalemia. Ardelyx has also developed a number of programs directed toward treating gastrointestinal, or GI, disorders, including the treatment of irritable bowel syndrome with constipation, or IBS-C.
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9	9	The company's portfolio is led by the development of tenapanor, a first-in-class inhibitor of NHE3. In its renal pipeline, tenapanor is being evaluated in a second Phase 3 trial for the treatment of hyperphosphatemia in patients with ESRD who are on dialysis. This registration trial follows a successful first Phase 3 trial completed in 2017, which achieved statistical significance for the primary endpoint. Ardelyx is also advancing a small molecule potassium secretagogue program, RDX013, for the potential treatment of hyperkalemia. The company believe that both tenapanor and RDX013 have the potential to provide treatment options that are differentiated significantly from binders, the current standards of care in both of these markets. The company believe its small molecule approach to treating these conditions could significantly reduce the pill burden for patients, leading to higher compliance, and offer completely new mechanisms of action that interact with receptors in the gut, potentially allowing improved efficacy in some patients.
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74	74	[[image:https://www.sec.gov/Archives/edgar/data/1437402/000155837018002056/ardx20171231x10k001.jpg]]
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76		-==== The hyperphosphatemia market ====
	76	+=== The hyperphosphatemia market ===
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78	78	Phosphate binders are the only drugs marketed for the treatment of hyperphosphatemia in ESRD patients. The various types of phosphate binders commercialized in the United States include the following:
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174	174	To support the global commercialization of tenapanor for IBS-C, Ardelyx is pursuing strategic collaborations to bring tenapanor to patients. In December 2017, the company entered into a license agreement to provide Fosun Pharma with the exclusive rights to develop and commercialize tenapanor in China for the treatment of patients with IBS-C and hyperphosphatemia related to chronic kidney disease.
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176		-==== The IBS-C market ====
	176	+=== The IBS-C market ===
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178	178	Numerous treatments exist for the constipation component of IBS-C, many of which are over-the-counter. There are three prescription products marketed for IBS-C: (i) Linzess (linaclotide), marketed by Ironwood Pharmaceuticals and Allergan, (ii) Amitiza (lubiprostone), marketed by Takeda and Sucampo, a wholly-owned subsidiary of Mallinckrodt, and (iii) Trulance (plecanatide), marketed by Synergy Pharmaceuticals.
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180	180	The company believe that tenapanor may offer a significant benefit over currently marketed drugs like Amitiza, Linzess and Trulance in part because of the profile demonstrated in its Phase 3 program, which showed best-in-class efficacy results for the 9-of-12 week combined responder rates. Within the United States, there are approximately 11 million patients that suffer that suffer from IBS-C. There is significant unmet need for prescription medications, where, according a 2015 American Gastroenterological Association report, only 1 in 4 treated patients are very satisfied with the current FDA approved treatments in IBS-C.
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182		-==== Other GI Programs ====
	182	+=== Other GI Programs ===
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184	184	In addition to tenapanor for IBS-C, Ardelyx has an early GI pipeline comprised of RDX8940, a minimally absorbed, oral TGR5 agonist for which the company submitted an investigational new drug application, or IND, in late 2016; RDX011, its second-generation NHE3 inhibitor; and its RDX023 program for the development of gut-biased farnesoid X receptor, or FXR, agonists. While Ardelyx is not currently actively developing these programs, they represent potential collaboration opportunities to support their continued development.
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186		-= INTELLECTUAL PROPERTY =
	186	+= Intellectual Property =
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188	188	The company's commercial success depends in part on its ability to obtain and maintain proprietary protection for its drug candidates, manufacturing and process discoveries, and other know-how, to operate without infringing the proprietary rights of others and to prevent others from infringing its proprietary rights. The company's policy is to seek to protect its intellectual property by, among other methods, filing U.S. and foreign patent applications related to its proprietary technology and inventions that are important to the development and operation of its business. The company also rely on trade secrets and careful monitoring of its proprietary information to protect aspects of its business that are not amenable to, or that the company do not consider appropriate for, patent protection.
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206	206	Ardelyx has patent applications pending in the United States and internationally that cover the compositions and methods of using its TGR5 agonists, its FXR agonists and compounds in its RDX013 program.
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208		-= MANUFACTURING =
	208	+= Manufacturing =
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210	210	To date, Ardelyx has relied upon third-party contract manufacturing organizations, or CMOs, to manufacture both the active pharmaceutical ingredient and final drug product dosage forms of its potential drug candidates used as clinical trial material. The company expect that the company will continue to rely upon CMOs for the manufacture of its clinical trial materials and for its commercial product requirements, when and if regulatory approval is received. The company's license agreements with KHK and Fosun Pharma require it to supply active pharmaceutical ingredient and final drug product dosage forms of tenapanor for their use in the development of tenapanor in each of their respective territories, and Ardelyx is further obligated to continue to supply active pharmaceutical ingredient to support their commercialization of tenapanor in each of their territories. The company expect that the company will use CMOs to satisfy its supply obligations to its collaboration partners.
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212		-= EMPLOYEES =
	212	+= Employees =
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214	214	As of December 31, 2017, the company had 75 full-time employees, including a total of 15 employees with Ph.D. degrees. Within its workforce, 54 employees are engaged in research and development and the remaining 21 in general management and administration, including finance, legal, and business development. None of its employees are represented by labor unions or covered by collective bargaining agreements. The company believe that the company maintain good relations with its employees.
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216		-= RESEARCH AND DEVELOPMENT =
	216	+= Research and Development =
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218	218	The company's research and development costs were $75.5 million, $94.2 million and $39.9 million in the years ended December 31, 2017, 2016 and 2015, respectivel