Description of Business and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2014 |
Organization | ' |
Organization |
Relypsa, Inc. (Relypsa or the Company) is a biopharmaceutical company dedicated to the development and commercialization of new non-absorbed polymeric drugs for important applications in renal, cardiovascular and metabolic disease. The Company commenced operations on October 29, 2007. The Company’s principal operations are based in Redwood City, California and it operates in one segment. |
The information included in this quarterly report on Form 10-Q should be read in conjunction with the financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the U.S. Securities Exchange Commission (SEC). |
On April 16, 2014, the Company completed an underwritten public offering of 4,130,611 shares of common stock at an offering price of $24.50 per share. The Company received aggregate net proceeds of $94.6 million, after deducting the underwriting discounts and offering related transaction costs. |
Basis of Presentation | ' |
Basis of Presentation |
There have been no material changes to the Company’s significant accounting policies during the six months ended June 30, 2014 as compared to the significant accounting policies described in the Company’s audited financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2013. |
The accompanying financial information for the three and six months ended June 30, 2014 is unaudited. These unaudited interim condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP and applicable rules and regulations of the SEC regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. In management’s opinion, the unaudited interim condensed financial statements have been prepared on the same basis as the audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, and include all adjustments, which include only normal recurring adjustments necessary for the fair presentation of our statement of financial position as of June 30, 2014, our statements of operations and comprehensive loss for the three and six months ended June 30, 2014 and our statements of cash flows for the six months ended June 30, 2014. The results for the three and six months ended June 30, 2014 are not necessarily indicative of the results expected for the full fiscal year or any other period(s). |
Use of Estimates | ' |
Use of Estimates |
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The preparation of these unaudited interim condensed financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to clinical trial accruals, fair value of assets and liabilities, income taxes, and stock-based compensation. Management bases its estimates on historical experience and on various other market-specific and relevant assumptions that management believes to be reasonable under the circumstances. Actual results could differ from those estimates. |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
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On June 10, 2014, FASB issued Accounting Standards Update No. 2014-10, Development Stage Entities: Elimination of Certain Financial Reporting Requirements. The update removes the definition of a development stage entity from FASB ASC 915 and eliminates the requirement for development stage entities to present inception-to-date information on the statements of operations, cash flows and stockholders’ deficit. The Company early adopted this standard for the period covered by the report herein. |
Liquidity | ' |
Liquidity |
In the course of its development activities, the Company has sustained significant operating losses and expects such losses to continue over the next few years. The Company’s success depends on the outcome of its research and development activities. From inception through June 30, 2014, the Company has incurred cumulative net losses of $248.9 million. Management expects to incur additional losses in the future to conduct product research and development and commercialization activities. Additional funding will be needed to support the planned commercial launch in the United States and as the Company builds out its sales capabilities. The Company intends to raise such funding through the issuance of additional equity, debt financings or other sources, such as strategic collaborations. However, if such financing is not available at adequate levels or on acceptable terms, the Company could be required to significantly reduce operating expenses and delay, reduce the scope of or eliminate some of its development programs or its commercialization efforts, enter into a collaboration or other similar arrangement with respect to commercialization rights to patiromer or any of its other product candidates, out-license intellectual property rights to patiromer or its other product candidates and sell unsecured assets, or a combination of the above, which may have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to fund its scheduled obligations on a timely basis or at all. |
Cash Equivalents | ' |
Cash Equivalents |
The Company considers all highly liquid investments purchased with original maturities of 90 days or less at the date of purchase to be cash equivalents. |
Short-Term Investments | ' |
Short-Term Investments |
Short-term investments consist of debt securities classified as available-for-sale and have maturities greater than 90 days, but less than 365 days from the date of acquisition. Short-term investments are carried at fair value based upon quoted market prices or pricing models for similar securities. Unrealized gains and losses on available-for-sale securities are excluded from earnings and are reported as a component of accumulated comprehensive income (loss). Realized gains or losses on the sale of all such securities are reported in interest and other income (expense), net and computed using the specific identification method. |
Restricted Cash | ' |
Restricted Cash |
Restricted cash related to the Company’s leases consists of irrevocable letters of credit that are collateralized by a restricted deposits held at the Company’s bank over a term that is consistent with the corresponding lease. |
Research and Development Expenses | ' |
Research and Development Expenses |
Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities including salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research-related overhead expenses and fees paid to external service providers and contract research and manufacturing organizations that conduct certain research and development activities on behalf of the Company. |
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Clinical Trial Accruals | ' |
Clinical Trial Accruals |
Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the actual costs through discussions with internal personnel and external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Contract Manufacturing Accruals | ' |
Contract Manufacturing Accruals |
Contract Manufacturing costs are a component of research and development expenses. The Company accrues and expenses contract manufacturing activities performed by third parties based upon actual or the estimated amount of work completed in accordance with agreements established with contract manufacturing organizations. The Company determines the actual costs or it estimates the costs through discussions with internal personnel and external service providers as to the manufacturing activities that were performed or completed and the agreed-upon fee to be paid for such services. |
Stock-Based Compensation | ' |
Stock-Based Compensation |
The Company accounts for stock-based compensation based on the fair value of the share-based awards that are ultimately expected to vest. The fair value of employee stock options granted is estimated on the date of grant using the Black-Scholes option pricing model, and is recognized in expense over the service period using the straight-line method, net of estimated forfeitures. Forfeiture estimates are adjusted to the extent that actual forfeitures differ from the prior estimates. |
The fair value of restricted stock unit awards used in our expense recognition method is based on the number of shares granted and the closing price of our common stock on the date of the grant. Such value is recognized as an expense over the service period using the straight-line method, net of estimated forfeitures. |
The Company records the expense attributed to nonemployee services paid with share-based awards based on the estimated fair value of the awards determined using the Black-Scholes option pricing model. The measurement of stock-based compensation for nonemployees is subject to periodic adjustments as the options vest, and the expense is recognized over the period during which services are received. |
Net Loss per Common Share Attributable to Common Stockholders | ' |
Net Loss per Common Share |
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per common share is calculated by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period using the treasury stock method. |
The following outstanding shares of common stock equivalents were excluded from the computations of diluted net loss per common share attributable to common stockholders for the periods presented as the effect of including such securities would be antidilutive (in thousands): |
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| | | June 30, | |
| | | 2014 | | | 2013 | |
Convertible preferred stock — as converted to common stock | | | | — | | | | 17,281 | |
Warrants to purchase convertible preferred stock — as converted to common stock | | | | — | | | | 2,298 | |
Warrants to purchase common stock | | | | 56 | | | | — | |
Options to purchase common stock | | | | 3,643 | | | | 2,168 | |
Restricted stock units | | | | 19 | | | | — | |
Common stock subject to repurchase | | | | 3 | | | | 5 | |
| | | | 3,721 | | | | 21,752 | |
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