Organization and Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2013 |
Accounting Policies [Abstract] | ' |
Reverse Stock Split | ' |
Reverse Stock Split |
In May 2013, our board of directors and our stockholders approved an amendment to the amended and restated certificate of incorporation to effect a one-for-16.7 reverse split of shares of common stock and to increase the number of authorized shares of common stock to 500,000,000, each of which was effected on May 21, 2013. |
Initial Public Offering | ' |
Initial Public Offering |
We completed our initial public offering (“IPO”) in August 2013. Inclusive of the underwriters’ exercise of the over-allotment option in connection with the IPO in September 2013, we issued 11,671,500 shares of common stock at a price of $4.00 per share, resulting in net proceeds of approximately $41.1 million, after deducting underwriting discounts of $3.3 million and offering costs of $2.3 million. Upon the closing of the IPO, all shares of convertible preferred stock then outstanding automatically converted into an aggregate of 9,396,767 shares of common stock. |
Principles of Consolidation | ' |
Principles of Consolidation |
In March 2013, we incorporated Regado Biosciences Europe Limited, a wholly owned subsidiary registered in England and Wales, in order to establish a legal presence in the European Union (EU) for the purpose of conducting clinical trials in the EU. Regado Biosciences Europe Limited had no operations for the three and nine months ended September 30, 2013. |
The accompanying consolidated financial statements include the accounts of Regado Biosciences, Inc. and its wholly owned subsidiary, Regado Biosciences Europe Limited. All significant intercompany accounts and transactions have been eliminated in consolidation. |
Basis of Accounting and Going Concern Uncertainty | ' |
Basis of Accounting and Going Concern Uncertainty |
Our financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and settlement of liabilities and commitments in the normal course of business. Operations since inception have consisted primarily of developing and acquiring product technologies and securing financing. |
The accompanying financial statements have been prepared assuming that we will operate as a going concern. We have suffered negative cash flows from operating activities of $22.1 million during the nine months ended September 30, 2013 and a net accumulated deficit of $130.8 million since inception as of September 30, 2013. Prior to our IPO, we were funded primarily through the issuance of preferred stock and debt. We will require additional capital until such time that we can generate operating revenue in excess of operating expenditures. Our plans include continued product development and a move toward completion of clinical trials. We will continue to closely monitor and analyze expenses and make adjustments as necessary to prioritize business operations. We believe that the net proceeds from the IPO will be sufficient for us to fund the REGULATE-PCI trial through the first interim analysis, which we expect will occur by the beginning of the second quarter of 2014, and to fund our operations through the second quarter of 2014. We will need to raise additional financing in the first half of 2014 to fund projected operations through 2014 and we can provide no assurances that such additional financing will be available on favorable terms, or at all. However, actual results may differ from estimates and the financial statements do not include any adjustments that might be necessary if we are unable to fund operations. |
Unaudited Interim Financial Data | ' |
Unaudited Interim Financial Data |
The accompanying interim consolidated financial statements are unaudited. These unaudited consolidated financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial information under Article 210.8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. These unaudited interim consolidated financial statements should be read in conjunction with the audited financial statements and the accompanying notes for the year ended December 31, 2012 included in our final prospectus dated August 22, 2013 filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, with the Securities and Exchange Commission on August 22, 2013. The unaudited interim consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments (consisting of normal recurring adjustments) necessary to state fairly our financial position as of September 30, 2013; the results of our operations for the three and nine months ended September 30, 2013 and 2012 and for the period from inception through September 30, 2013; and our cash flows for the nine months ended September 30, 2013 and 2012 and for the period from inception through September 30, 2013. The results of operations for the three and nine months ended September 30, 2013 are not necessarily indicative of the operating results for the full year or any other interim period. |
Use of Estimates | ' |
Use of Estimates |
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Reclassifications | ' |
Reclassifications |
We have reclassified supplies inventory, net to other current assets in the accompanying consolidated balance sheet at December 31, 2012. This reclassification did not have any impact on our loss from operations or net loss for the three or nine months ended September 30, 2012, or on total assets as of December 31, 2012. |
We have reclassified all laboratory and clinical indirect costs and stock compensation costs for laboratory and clinical personnel, for the three and nine months ended September 30, 2012, and for the period from inception through December 31, 2012, from general and administrative expense to research and development expense in the accompanying consolidated statements of comprehensive loss. These reclassifications did not have any impact on our loss from operations or net loss for the three or nine months ended September 30, 2012, or for the period from inception through December 31, 2012. |
We have reclassified patent and product license amortization and patent impairment costs for the three and nine months ended September 30, 2012, and for the period from inception through December 31, 2012, from general and administrative expense to research and development expense in the accompanying consolidated statements of comprehensive loss. These reclassifications did not have any impact on our loss from operations or net loss for the three or nine months ended September 30, 2012, or for the period from inception through December 31, 2012. |
Fair Value of Financial Instruments | ' |
Fair Value of Financial Instruments |
The carrying amount of certain of our financial instruments, including cash and cash equivalents, prepaid expenses, and accounts payable approximate fair value due to the short maturities of those financial instruments. The carrying amount of our debt at September 30, 2013 and December 31, 2012 approximated fair value. The estimated fair value of our debt at September 30, 2013 and December 31, 2012, respectively, was determined based on available market information for alternative financing under similar terms. In conjunction with the refinancing of our long term debt in May 2013, we held a warrant liability at September 30, 2013 that is required to be measured at fair value on a recurring basis (see Note 3). |
Our valuation of financial instruments is based on a three-tiered approach, which requires that fair value measurements be classified and disclosed in one of three tiers. These tiers are: Level 1, defined as quoted prices in active markets for identical assets or liabilities; Level 2, defined as valuations based on observable inputs other than those included in Level 1, such as quoted prices for similar assets and liabilities in active markets, or other inputs that are observable or can be corroborated by observable input data; and Level 3, defined as valuations based on unobservable inputs reflecting our own assumptions, consistent with reasonably available assumptions made by other market participants. |
Cash and Cash Equivalents | ' |
Cash and Cash Equivalents |
We consider all interest-bearing investments due on demand and all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. Cash and cash equivalents included cash of $253,000 and $235,000 at September 30, 2013 and December 31, 2012, respectively. Cash and cash equivalents at September 30, 2013 and December 31, 2012 also included investments of $43.2 million and $14.5 million, respectively, in money market funds invested in U.S. Treasury securities with original maturities of less than three months. Cash deposits are held in federally insured financial institutions in the United States of America. We maintain cash in accounts which are in excess of federally insured limits. |
Significant Concentrations | ' |
Significant Concentrations |
The financial instruments that potentially subject us to concentrations of credit risk are cash and cash equivalents. Our cash and cash equivalents are maintained primarily with two financial institutions. |
We do not have a manufacturing infrastructure and do not intend to develop one for the foreseeable future . We have agreements with third-party contract manufacturing organizations, or CMOs, to supply bulk drug substances for our product candidates and with third parties to formulate, package and distribute our drug product candidates. Our employees include professionals with expertise in pharmaceutical manufacturing development who oversee the manufacture and distribution of our drug product candidates by third-party companies. We believe that we have sufficient amounts of REG1 on hand to complete a minimum of 50% enrollment in the REGULATE-PCI trial. All of the drug substances used in our product candidates are manufactured by single suppliers. While we have not experienced any supply disruptions, the number of oligonucleotide manufacturers is limited. In the event it is necessary or advisable to acquire supplies from an alternative supplier, we might not be able to obtain them on commercially reasonable terms, if at all. It could also require significant time and expense to redesign our manufacturing processes to work with another company. Formulation and distribution of our finished drug product candidates are also conducted by a single supplier but we believe that alternative sources for these services are readily available on commercially reasonable terms (see Note 4). |
Clinical Trial Supplies | ' |
Clinical Trial Supplies |
We capitalize materials that will be used in our REG I clinical trials that also have an alternative future use in either ongoing or future clinical research and development projects. Clinical trial supplies may comprise material used to manufacture active pharmaceutical ingredients (“API”) used to develop our product candidates, in-process or completed API, in-process or completed unlabeled finished drug product and labeled finished drug product. Clinical trial supplies are stated at the lower of cost or market, using the first-in, first-out method (“FIFO”), and are reported in the accompanying consolidated balance sheets in other current assets. Clinical trial supplies that are determined to be unsuitable for future use are immediately expensed; otherwise clinical trial supplies are expensed when shipped to clinical sites for use in clinical studies or when used in other research and development projects. |
We utilize CMOs to produce API and finished drug product for use in clinical trials. As we do not have facilities that meet the requisite regulatory requirements for storage of API or finished drug product produced, we use a third-party facility for storage. Upon release from the manufacturer, API is shipped to a third-party storage facility. For production of finished drug product, API is shipped from the storage facility to the finished drug product manufacturing site. Unlabelled finished drug product is either shipped from the manufacturer back to the third-party storage facility or directly to the third-party labeling site. Labeled finished drug product is held by the third-party labeling site until it is shipped to the clinical sites for trial use. |
We do not have multiple sources of supply for the components of our finished drug product. If we are unable to obtain the supplies needed at a reasonable price or on a timely basis, it could have a material adverse effect on our ability to complete the development of our finished drug product. |
As of September 30, 2013 clinical trial supplies included in other current assets were $4.7 million, of which $1.5 million and $3.2 million represented API held at the third-party storage facility and drug product located at depots, respectively. As of December 31, 2012, clinical trial supplies included in other current assets were $4.5 million which represented API held at the third-party storage facility. |
Clinical Agreements | ' |
Clinical Agreements |
We enter into various clinical trial agreements with academic research organizations (“AROs”) and clinical research organizations (“CROs”) for the planning, management and execution of clinical trials. The financial terms of these agreements are subject to negotiation, vary from contract to contract, and may result in uneven payment flows. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. Costs for ARO and CRO contracts are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided by vendors on their actual costs incurred; such costs are charged to research and development expense in the accompanying consolidated statement of comprehensive loss. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the research and development expense. Upfront refundable contract signing fees are amortized over the life of the respective contract; unamortized contract signing fees are included in other non-current assets. |
Included in the accompanying consolidated balance sheet as of September 30, 2013 are $2.7 million of prepaid costs that will be applied to final invoices as required under the respective contract, and $1.9 million of other non-current assets which represent upfront contract signing costs that will be amortized over the life of the respective contract, or approximately three years. |
In general, our ARO and CRO service agreements permit either party to terminate at will, although we would continue to be responsible for payment of all services completed (or pro-rata completed) at the time of notice of termination, plus any non-cancellable expenses that have been entered into by the ARO and CRO on the Company’s behalf. Accordingly, such expenses would be accrued at time of contract termination and any prepaid expenses and unamortized advance payments would be expensed, accordingly. |
Intangibles | ' |
Intangibles |
The following information details the carrying amounts and accumulated amortization of our intangible assets subject to amortization (in thousands): |
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| | As of September 30, 2013 | | | As of December 31, 2012 | |
| | Weighted | | Gross | | | Accumulated | | | Net | | | Gross | | | Accumulated | | | Net | |
Average | Carrying | Amortization | Carrying | Carrying | Amortization | Carrying |
Useful Life | Amount | | Amount | Amount | | Amount |
Remaining | | | | | | |
Identifiable intangible assets: | | | | | | | | | | | | | | | | | | | | | | | | | | |
Patents | | 8.1 years | | $ | 1,706 | | | $ | (446 | ) | | $ | 1,260 | | | $ | 1607 | | | $ | (349 | ) | | $ | 1,258 | |
Product licenses | | 2.1 years | | | 1,554 | | | | (1,417 | ) | | | 137 | | | | 1,547 | | | | (1,439 | ) | | | 108 | |
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Total | | 7.9 years | | $ | 3,260 | | | $ | (1,863 | ) | | $ | 1,397 | | | $ | 3,154 | | | $ | (1,788 | ) | | $ | 1,366 | |
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Expected future amortization expenses for intangible assets as of September 30, 2013 are as follows: |
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For the year ending December 31: | | Amount | | | | | | | | | | | | | | | | | | | | | | | |
2013 | | $ | 40 | | | | | | | | | | | | | | | | | | | | | | | |
2014 | | | 157 | | | | | | | | | | | | | | | | | | | | | | | |
2015 | | | 149 | | | | | | | | | | | | | | | | | | | | | | | |
2016 | | | 149 | | | | | | | | | | | | | | | | | | | | | | | |
2017 | | | 149 | | | | | | | | | | | | | | | | | | | | | | | |
Thereafter | | | 753 | | | | | | | | | | | | | | | | | | | | | | | |
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| | $ | 1,397 | | | | | | | | | | | | | | | | | | | | | | | |
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We record amortization of patent and product license costs in research and development expense in the accompanying consolidated statements of comprehensive loss. |
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Patents |
Patent costs consist of expenditures incurred for various patent applications. Upon receiving a patent grant, such respective costs are amortized over the remaining life of the patent. As of September 30, 2013 and December 31, 2012, we had $605,000 and $405,000 of costs related to patents that have not yet been granted. |
The impairment of patents occurs when a patent that has been applied for becomes expired or abandoned. Once the status of the patent changes to expired or abandoned, the associated costs for the patent application are expensed to research and development in the accompanying consolidated statements of comprehensive loss. Patent impairment expense recorded was $0 and $3,000 for the three months ended September 30, 2013 and 2012, respectively, and $10,000 and $8,000 for the nine months ended September 30, 2013 and 2012, respectively, and $174,000 for the period from inception to September 30, 2013. |
Product Licenses |
We have primary license agreements with Duke University, Archemix Corp. and Nektar Therapeutics AL and all of the licenses are being amortized over the stated contractual life. |
Grant Revenue | ' |
Grant Revenue |
We were awarded several grants under the Therapeutic Discovery Project Grant program during 2010, related to research amounts previously expensed and have historically received modest other grant funding. The total amount recognized within Grant Revenue on the consolidated statement of comprehensive loss was $0 for the three and nine months ended September 30, 2013 and 2012, respectively, and $832 for the period from inception to September 30, 2013. |
Stock-based Compensation | ' |
Stock-based Compensation |
We grant stock options to employees and non-employees with an exercise price equal to fair market value, as defined in the Equity Compensation Plan. |
In accordance with FASB ASC Topic 718, Stock Compensation, as modified or supplemented, we measure compensation cost for share-based payment awards granted to employees and non-employee directors at fair value using the Black-Scholes option-pricing model. We recognize compensation expense on a straight-line basis over the service period for awards expected to vest. Share-based compensation cost related to share-based payment awards granted to non-employees is adjusted each reporting period for changes in the fair value of our common stock until the measurement date. The measurement date is generally considered to be the date when all services have been rendered or the date that options are fully vested. Expense is recognized over the related service period. |
Research and Development | ' |
Research and Development |
Research and development expenses consist of the costs associated with our research and discovery activities, conducting preclinical studies and clinical trials and activities related to regulatory filings. Research and development expenses consist of: |
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| • | | employee salaries and related expenses, which include compensation benefits for the personnel involved in drug discovery and development activities, including stock based compensation; | | | | | | | | | | | | | | | | | | | | | | | |
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| • | | external research and development expenses incurred under agreements with third party AROs and CROs and investigative sites (see Note 2—Clinical Agreements); | | | | | | | | | | | | | | | | | | | | | | | |
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| • | | clinical trial supplies when used or upon determination that they have no alternative future use, and clinical trial supplies shipped to clinical sites for use in clinical studies(see Note 2—Clinical Trial Supplies); | | | | | | | | | | | | | | | | | | | | | | | |
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| • | | patent and product license amortization, and license fees for and milestone payments related to in-licensed products and technologies; and | | | | | | | | | | | | | | | | | | | | | | | |
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| • | | overhead costs related to facilities, depreciation, research and development management, and research and development support services and supplies. | | | | | | | | | | | | | | | | | | | | | | | |
Conducting a significant amount of research and development is central to our business model. Product candidates in late stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of late stage clinical trials. We plan to increase research and development expenses for the foreseeable future as we seek to complete the development of our lead product candidate, REG1. |
Recent Accounting Pronouncements | ' |
Recent Accounting Pronouncements |
Section 107 of the Jumpstart our Business Startups Act of 2012, or the JOBS Act, provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. However, we are choosing to “opt out” of such extended transition period, and as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable. |