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Nature of Organization and Operations
6 Months Ended
Jun. 30, 2016
Accounting Policies [Abstract]  
Nature of Organization and Operations

1. Nature of Organization and Operations

Incorporated in Delaware in 2007, Akebia Therapeutics, Inc. (Akebia, or the Company) is a biopharmaceutical company focused on the development of novel proprietary therapeutics based on hypoxia inducible factor, or HIF, biology and the commercialization of these products for patients with serious unmet medical needs. HIF is the primary regulator of the production of red blood cells, or RBCs, in the body and a potentially novel mechanism for the treatment of anemia secondary to chronic kidney disease, or CKD. Pharmacologic modulation of the HIF pathway may also have broader therapeutic applications in acute renal failure, organ protection, ischemia-reperfusion injury, cancer, ophthalmology, and inflammatory diseases. The Company’s lead product candidate, vadadustat, formerly known as AKB-6548, is being developed as a once-daily, oral therapy for the treatment of anemia of CKD.  The Company has successfully completed Phase 2 development demonstrating that vadadustat can safely and predictably raise hemoglobin levels in patients with anemia related to CKD.  

The Company’s operations to date have been limited to organizing and staffing the Company, business planning, raising capital, acquiring and developing its technology, identifying potential product candidates and undertaking preclinical and clinical studies. The Company has not generated any product revenue to date and may never generate any product revenue in the future. The Company’s product candidates are subject to long development cycles and the Company may be unsuccessful in its efforts to develop, obtain regulatory approval for or market its product candidates.

The Company is subject to a number of risks including, but not limited to, the need to obtain adequate additional funding, including the resources necessary to fund its recently commenced global Phase 3 development of vadadustat in non-dialysis and dialysis patients with anemia related to CKD. In December 2015, the Company began dosing patients in its Phase 3 vadadustat program in non-dialysis patients, PRO2TECT. The Company initiated its Phase 3 program of vadadustat in dialysis-dependent patients, INNO2VATE, in August 2016 and anticipates full enrollment by early 2018. The Company has engaged a clinical research organization for the PRO2TECT and INNO2VATE programs. The Company expects the cost of the Phase 3 program to be in the range of $80,000 to $85,000 per patient, and it plans to enroll approximately 3,100 patients in PRO2TECT and approximately 2,600 patients in INNO2VATE.

The Company is also subject to a number of other risks including possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, the development of new technological innovations by competitors, the need to successfully commercialize and gain market acceptance of any of the Company’s products that are approved and uncertainty around intellectual property matters. If the Company does not successfully commercialize any of its products, it will be unable to generate product revenue or achieve profitability.

In December 2015, the Company entered into a collaboration agreement with Mitsubishi Tanabe to develop and commercialize vadadustat in Japan and certain other countries in Asia for total milestone payments of up to $350.0 million, including up to $100.0 million in upfront and development payments, of which $40.0 million was received in January 2016.  If Japanese patients are not included in either the global Phase 3 PRO2TECT or INNO2VATE programs, $20.0 million of the $40.0 million received would be used to fund further local development of vadadustat in Japan or be refunded to Mitsubishi.  In addition, the Company will receive tiered double-digit royalty payments on sales of vadadustat.

Through the end of 2015 the Company had raised approximately $187.4 million of net proceeds from three underwritten public offerings, including our initial public offering.  In January 2016, the Company completed a follow-on public offering whereby the Company sold 7,250,000 shares of common stock at a price of $9.00 per share.  The aggregate net proceeds received by the Company from the offering were approximately $61.0 million, net of underwriting discounts and commissions and estimated offering expenses payable by the Company.

In May 2016, the Company entered into a Sales Agreement with Cantor Fitzgerald & Co. to periodically sell up to $75 million of shares of common stock in an at-the-market, or ATM, offering.  During the second quarter of 2016, there were no sales of common stock pursuant to the Sales Agreement.

The Company believes that its cash, cash equivalents and available for sale securities of $188.6 million as of June 30, 2016 is sufficient to fund its current operating plan through the second quarter of 2017.  There can be no assurance, however, that the current operating plan will be achieved in the timeframe anticipated by the Company, or that its cash resources will fund the Company’s operating plan for the period anticipated by the Company or that additional funding will be available on terms acceptable to the Company, or at all.

 

As of June 30, 2016, the Company had cash and cash equivalents of approximately $188.6 million and current accounts payable and accrued expenses of $20.9 million. The Company has incurred substantial losses since inception, primarily due to investments in research and development, and we expect to continue to incur substantial losses over the next four to five years. Without any additional financings or other transactions, the Company anticipates that it will have sufficient cash available to support its development programs and business operations through the second quarter of 2017.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.  In the future, the Company’s ability to continue as a going concern is dependent on its ability to raise additional capital to fund its research and development programs and meet its obligations on a timely basis.  As of June 30, 2016, the financial statements do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue its existence.

 

To potentially mitigate the risk that the Company may be unable to continue as a going concern, it plans to pursue all or a combination of potential strategic alliances, collaboration agreements and other strategic transactions.  The Company also may seek additional capital through public or private equity offerings (including its ATM offering), which could have a dilutive impact on stockholders and the issuance, or even potential issuance, of shares could have a negative effect on the market price of common stock.  Even if the Company is able to secure additional capital, such financings may only be available on unattractive terms, or could result in significant dilution of stockholders’ interests.  If none of the foregoing alternatives is available, or if available, the Company is unable to raise sufficient capital through such transactions, it may be forced to limit or cease its development activities.