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April 27, 2015 1:10 AM ET


Company Overview of Relypsa, Inc.

Company Overview

Relypsa, Inc., a biopharmaceutical company, focuses on the development and commercialization of non-absorbed polymeric drugs to treat disorders in the areas of renal, cardiovascular, and metabolic diseases in the United States. Its lead product candidate includes Patiromer, a non-absorbed potassium binding polymer that completed Phase III clinical trial for the treatment of hyperkalemia. The company was founded in 2007 and is based in Redwood City, California.

100 Cardinal Way

Redwood City, CA 94063

United States

Founded in 2007

115 Employees



Key Executives for Relypsa, Inc.

Chief Executive Officer, President and Director
Age: 49
Total Annual Compensation: $540.1K
Total Annual Compensation: $172.5K
Chief Medical Officer and Senior Vice President
Age: 43
Total Annual Compensation: $321.9K
Senior Vice President of Pharmaceutical Development and Regulatory Affairs
Age: 61
Total Annual Compensation: $304.0K
Chief Commercial Officer and Senior Vice President
Age: 45
Total Annual Compensation: $170.8K
Compensation as of Fiscal Year 2014.

Relypsa, Inc. Key Developments

Relypsa Inc. Presents Sub-Group Analysis from Phase 3 Study of Patiromer FOS in Patients with Advanced Chronic Kidney Disease

Relypsa Inc. announced that data from a Phase 3 clinical program showing that Patiromer for Oral Suspension (Patiromer FOS), the company's product candidate, was effective in reducing potassium levels and preventing a recurrence of hyperkalemia in patients with advanced (stage 4-5) chronic kidney disease (CKD) receiving ongoing treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors were presented as a poster at the National Kidney Foundation 2015 Spring Clinical Meeting. The results are from a sub-group analysis of the two part Phase 3 trial, OPAL-HK, conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration. The phase 3 OPAL-HK trial primary outcomes were combined with results from Relypsa's broader clinical development program to support the company's New Drug Application for Patiromer FOS. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of October 21, 2015 for completion of the review of the NDA. Poster #240, entitled 'Patiromer Reduced Recurrent Hyperkalemia in Patients with Advanced CKD on RAAS Inhibitors: results from the randomized Phase 3 OPAL-HK study,' reports that a statistically significant reduction in potassium levels from baseline were observed in 106 patients with stage 4-5 CKD treated with Patiromer FOS during an initial four week treatment phase. Baseline demographics include estimated glomerular filtration rate (eGFR) levels of 21.3 mL/min/1.73 m2, 62% of patients with type 2 diabetes, 97% with hypertension, and 23% with a history of myocardial infarction. Patients had mean Charlson Comorbidity Index (CCI) score of 6.5, consistent with a significant disease burden and high mortality risk. All patients were receiving RAAS inhibitor therapy, including 40% at investigator-determined maximal dose. At the conclusion of the four week treatment phase, 72% of patients had potassium levels within a normal target range. Following the treatment phase, eligible patients underwent an eight week placebo-controlled withdrawal phase in which 69% of placebo patients had at least one recurrent hyperkalemia event (serum potassium = 5.5 mEq/L) versus 20% of Patiromer FOS patients. Additionally, in a pre-specified exploratory analysis, 65% of placebo patients required an adjustment or discontinuation of RAAS inhibitor therapy due to hyperkalemia during the withdrawal phase as compared to 14% of patients treated with Patiromer FOS. Mean levels of calcium and magnesium consistently remained within normal ranges in patients treated throughout both phases of the study. Overall, Patiromer FOS was well tolerated, with a low rate of discontinuations due to adverse events and a low rate of hypokalemia.

Relypsa, Inc. Announces Unaudited Earnings Results for the Fourth Quarter and Year Ended December 31, 2014; Provides Financial Guidance for the Full Year of 2015

Relypsa, Inc. announced unaudited earnings results for the fourth quarter and year ended December 31, 2014. Net loss attributable to common stockholders for the fourth quarter 2014 was $27.6 million, or $0.80 per share, compared to $9.1 million, or $0.68 per share, for the comparable period in 2013.  The increase was primarily due to a decrease in fair value of convertible preferred stock warrants during 2013 and an increase in operating expenses during 2014, partially offset by a deemed dividend to preferred stockholders due to the issuance of warrants as part of the company's Series C-2 Preferred Stock financing in October 2013. Loss from operations was $27,082,000 against $14,646,000 a year ago. Net loss attributable to common stockholders for the full year 2014 was $79.9 million, or $2.43 per share, compared to $81.2 million, or $22.42 per share, in 2013. The decrease was primarily due to a deemed dividend to preferred stockholders due to the issuance of warrants as part of the company's Series C-2 Preferred Stock financing in October 2013, partially offset by an increase in operating expenses during 2014. Loss from operations was $78,141,000 against $70,911,000 a year ago. For the full year 2015, the company expects operating expenses in the range of approximately $180.0 to $200.0 million, including stock-based compensation of approximately $10.0 to $15.0 million. The 2015 operating expenses will be primarily driven by ongoing development activities as it pursue regulatory approval of Patiromer FOS, expansion of commercial launch preparation activities related to Patiromer FOS, including significant headcount growth and the manufacture of commercial supply, and increases in general and administrative infrastructure.

Relypsa, Inc. Presents at 27th Annual ROTH Conference, Mar-10-2015 09:30 AM

Relypsa, Inc. Presents at 27th Annual ROTH Conference, Mar-10-2015 09:30 AM. Venue: The Ritz Carlton, 1 Ritz Carlton Dr, Dana Point, CA 92629, United States. Speakers: Kristine M. Ball, Chief Financial Officer, Principal Accounting Officer and Senior Vice President.

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