ARDELYX, INC. 10-Q

ITEM 1. FINANCIAL STATEMENTS ARDELYX, INC. CONDENSED BALANCE SHEETS (Unaudited) (in thousands, except share and per share amounts) June 30, 2021 December 31, 2020 Assets Current assets: Cash and cash equivalents $ 86,745 $ 91,032 Short-term investments 85,064 95,452 Prepaid expenses and other current assets 14,683 8,202 Total current assets 186,492 194,686 Property and equipment, net 2,666 1,936 Long-term investments — 2,114 Right-of-use assets, net 14,519 2,274 Other assets 1,305 552 Total assets $ 204,982 $ 201,562 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 2,587 $ 5,626 Accrued compensation and benefits 5,939 5,672 Current portion of operating lease liability 3,184 2,117 Loan payable, current portion 36,111 4,167 Deferred revenue 1,412 4,177 Accrued expenses and other current liabilities 8,552 6,657 Total current liabilities 57,785 28,416 Operating lease liability, net of current portion 11,548 413 Loan payable, net of current portion 15,133 46,621 Deferred revenue, non-current 2,947 — Total liabilities 87,413 75,450 Commitments and contingencies (Note 11) Stockholders’ equity: Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively. — — Common stock, $ 0.0001 par value; 300,000,000 shares authorized; 102,967,017 and 93,599,975 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively. 10 9 Additional paid-in capital 750,664 680,872 Accumulated deficit ( 633,109 ) ( 554,765 ) Accumulated other comprehensive income (loss) 4 ( 4 ) Total stockholders’ equity 117,569 126,112 Total liabilities and stockholders’ equity $ 204,982 $ 201,562 The accompanying notes are an integral part of these condensed financial statements. 2 Table of Contents ARDELYX, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Revenues: Collaborative development revenue $ 1,310 $ 1,125 $ 2,764 $ 2,300 Product supply revenue — 5 126 43 Licensing revenue 3 706 5,005 706 Total revenues 1,313 1,836 7,895 3,049 Operating expenses: Cost of revenue — 141 1,000 141 Research and development 26,021 18,864 46,477 34,708 General and administrative 20,124 7,038 37,255 14,176 Total operating expenses 46,145 26,043 84,732 49,025 Loss from operations ( 44,832 ) ( 24,207 ) ( 76,837 ) ( 45,976 ) Interest expense ( 1,202 ) ( 1,226 ) ( 2,302 ) ( 2,583 ) Other income, net 847 477 798 1,230 Loss before provision for income taxes ( 45,187 ) ( 24,956 ) ( 78,341 ) ( 47,329 ) Provision for income taxes 2 — 3 — Net loss $ ( 45,189 ) $ ( 24,956 ) $ ( 78,344 ) $ ( 47,329 ) Net loss per common share, basic and diluted $ ( 0.45 ) $ ( 0.28 ) $ ( 0.79 ) $ ( 0.53 ) Shares used in computing net loss per share - basic and diluted 100,040,083 89,080,046 98,617,564 88,890,353 Comprehensive loss: Net loss $ ( 45,189 ) $ ( 24,956 ) $ ( 78,344 ) $ ( 47,329 ) Unrealized gains on available-for-sale securities 11 361 8 297 Comprehensive loss $ ( 45,178 ) $ ( 24,595 ) $ ( 78,336 ) $ ( 47,032 ) The accompanying notes are an integral part of these condensed financial statements. 3 Table of Contents ARDELYX, INC. CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY For the Three and Six Months ended June 30, 2021 (Unaudited) (in thousands, except shares) Three Months Ended June 30, 2021 Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income Total Stockholders' Equity Shares Amount Balance as of March 31, 2021 98,688,577 $ 10 $ 718,728 $ ( 587,920 ) $ ( 7 ) $ 130,811 Issuance of common stock under employee stock purchase plan — — — — — — Issuance of common stock upon exercise of options 194,799 — 543 — — 543 Issuance of common stock upon vesting of restricted stock units 44,684 — — — — — Issuance of common stock in at-the-market offering 4,038,957 — 28,174 28,174 Stock-based compensation — — 3,219 — — 3,219 Unrealized gains on available-for-sale securities — — — — 11 11 Net loss — — — ( 45,189 ) — ( 45,189 ) Balance as of June 30, 2021 102,967,017 $ 10 $ 750,664 $ ( 633,109 ) $ 4 $ 117,569 Six Months Ended June 30, 2021 Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income Total Stockholders' Equity Shares Amount Balance as of December 31, 2020 93,599,975 $ 9 $ 680,872 $ ( 554,765 ) $ ( 4 ) $ 126,112 Issuance of common stock under employee stock purchase plan 102,208 — 478 — — 478 Issuance of common stock upon exercise of options 205,306 — 563 — — 563 Issuance of common stock upon vesting of restricted stock units 79,784 — — — — — Issuance of common stock in at-the-market offering 8,979,744 1 62,445 — — 62,446 Stock-based compensation — — 6,306 — — 6,306 Unrealized gains on available-for-sale securities — — — — 8 8 Net loss — — — ( 78,344 ) — ( 78,344 ) Balance as of June 30, 2021 102,967,017 $ 10 $ 750,664 $ ( 633,109 ) $ 4 $ 117,569 The accompanying notes are an integral part of these condensed financial statements. 4 Table of Contents ARDELYX, INC. CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY For the Three and Six Months ended June 30, 2020 (Unaudited) (in thousands, except shares) Three Months Ended June 30, 2020 Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income Total Stockholders' Equity Shares Amount Balance as of March 30, 2020 89,035,096 $ 9 $ 650,617 $ ( 482,825 ) $ ( 44 ) $ 167,757 Issuance of common stock for services 42,403 — 310 — — 310 Issuance of common stock upon exercise of options 63,064 — 204 — — 204 Stock-based compensation — — 2,674 — — 2,674 Unrealized gains on available-for-sale securities — — — — 361 361 Net loss — — — ( 24,956 ) — ( 24,956 ) Balance as of June 30, 2020 89,140,563 $ 9 $ 653,805 $ ( 507,781 ) $ 317 $ 146,350 Six Months Ended June 30, 2020 Common Stock Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income Total Stockholders' Equity Shares Amount Balance as of December 31, 2019 88,817,741 $ 9 $ 647,078 $ ( 460,452 ) $ 20 $ 186,655 Issuance of common stock under employee stock purchase plan 75,804 — 375 — — 375 Issuance of common stock for services 42,403 — 310 — — 310 Issuance of common stock upon exercise of options 204,615 — 420 — — 420 Stock-based compensation — — 5,622 — — 5,622 Unrealized gains on available-for-sale securities — — — — 297 297 Net loss — — — ( 47,329 ) — ( 47,329 ) Balance as of June 30, 2020 89,140,563 $ 9 $ 653,805 $ ( 507,781 ) $ 317 $ 146,350 The accompanying notes are an integral part of these condensed financial statements. 5 Table of Contents ARDELYX, INC. CONDENSED STATEMENTS OF CASH FLOWS (Unaudited) (in thousands) Six Months Ended June 30, 2021 2020 Operating activities Net loss $ ( 78,344 ) $ ( 47,329 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation expense 787 960 Amortization of deferred financing costs 316 282 Amortization of deferred compensation for services 145 158 Amortization of (discount) premium on investment securities 274 ( 227 ) Non-cash lease expense 1,318 1,025 Stock-based compensation 6,306 5,622 Change in derivative liabilities ( 713 ) 152 Non-cash interest associated with debt discount accretion 141 257 Changes in operating assets and liabilities: Prepaid expenses and other assets ( 7,379 ) ( 2,144 ) Accounts payable ( 3,039 ) 2,025 Accrued compensation and benefits 267 ( 1,372 ) Operating lease liabilities ( 1,361 ) ( 1,251 ) Accrued and other liabilities 2,607 174 Deferred revenue 182 ( 2,300 ) Net cash used in operating activities ( 78,493 ) ( 43,968 ) Investing activities Proceeds from maturities and redemptions of investments 60,550 25,519 Purchases of investments ( 48,314 ) ( 62,960 ) Purchases of property and equipment ( 1,517 ) ( 25 ) Net cash provided by (used in) investing activities 10,719 ( 37,466 ) Financing activities Proceeds from issuance of common stock in at-the-market offering, net of issuance costs 62,446 — Proceeds from issuance of common stock under equity incentive and stock purchase plans 1,041 795 Net cash provided by financing activities 63,487 795 Net decrease in cash and cash equivalents ( 4,287 ) ( 80,639 ) Cash and cash equivalents at beginning of period 91,032 181,133 Cash and cash equivalents at end of period $ 86,745 $ 100,494 Supplementary disclosure of cash flow information: Cash paid for interest $ 1,936 $ 2,146 Cash paid for income taxes $ 3 $ — Supplementary disclosure of non-cash activities: Right-of-use assets obtained in exchange for lease obligations $ 14,379 $ — Issuance of common stock for services $ — $ 311 The accompanying notes are an integral part of these condensed financial statements. 6 Table of Contents ARDELYX, INC . NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited) (amounts in thousands, except per share amounts and where otherwise noted) NOTE 1. ORGANIZATION AND BASIS OF PRESENTATION Ardelyx, Inc. (the “Company,” “we,” “us” or “our”) is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases. We operate in one business segment, which is the research, development and commercialization of biopharmaceutical products. Basis of Presentation These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the requirements of the Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules and regulations, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted. These condensed financial statements have been prepared on the same basis as our most recent annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments necessary to present fairly our financial position at June 30, 2021 and results of operations, changes in stockholders’ equity, and cash flows for the interim periods ended June 30, 2021 and 2020. The accompanying condensed financial statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020. The results for the three and six months ended June 30, 2021 are not necessarily indicative of results to be expected for the entire year ending December 31, 2021, or for any other interim period or future year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and judgments that affect the amounts reported in the financial statements and accompanying notes thereto. On an ongoing basis, management evaluates its estimates, including those related to recognition of revenue, clinical trial accruals, contract manufacturing accruals, the 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 materially differ from those estimates. Liquidity As of June 30, 2021, we had cash, cash equivalents and marketable securities of approximately $ 171.8 million. We believe our current available cash, cash equivalents marketable securities will be sufficient to fund our planned expenditures and meet our obligations for at least 12 months following the filing of this Report on Form 10-Q. On July 28, 2021, we received a Complete Response Letter ("CRL") from the U.S. Food and Drug Administration ("FDA") regarding our New Drug Application ("NDA") for the control of serum phosphorus in adult patients with chronic kidney disease ("CKD") on dialysis in which the FDA noted additional requirements would need to be met in order to obtain approval for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. On July 29, 2021 we entered into a Fourth Amendment to our Term Loan Agreement which extended the period of time that we are permitted to make interest-only payments on the Term Loan to December 1, 2021, provided, however, if the FDA does not approve our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on or before October 25, 2021, then the interest-only period will expire and principal repayments will be required to begin on November 1, 2021. Further, on July 29, 2021, our Board of Directors approved, and on August 2, 2021 we began implementing, a restructuring plan to better align our workforce and anticipated commercial and development spend with our capital resources and the needs of our business following the receipt of the CRL. For additional information see Note 12, Subsequent Events. Failure to raise sufficient capital when needed or generate product revenue will further impact our ability to pursue our business strategies and could require us to further delay, scale back or discontinue one or more of our product development programs, commercialization efforts, or other aspects of our business plans. 7 Table of Contents Summary of Significant Accounting Policies There have been no changes to the significant accounting policies disclosed in our most recent Annual Report on Form 10-K. Recent Accounting Pronouncements New Accounting Pronouncements - Recently Adopted We have adopted no new accounting pronouncements other than those disclosed in our most recent Annual Report on Form 10-K. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , an amendment which modifies the measurement and recognition of credit losses for most financial assets and certain other instruments. The amendment updates the guidance for measuring and recording credit losses on financial assets measured at amortized cost by replacing the “incurred loss” model with an “expected loss” model. Accordingly, these financial assets will be presented at the net amount expected to be collected. The amendment also requires that credit losses related to available-for-sale debt securities be recorded as an allowance through net income rather than reducing the carrying amount under the current, other-than-temporary-impairment model. For smaller reporting companies the guidance is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. On June 30, 2021, our public float exceeded $700 million and therefore, on December 31, 2021, we will no longer qualify as a “smaller reporting company” and will instead be considered a large accelerated filer. We expect to adopt Topic 326 in the fourth quarter of 2021. We do not expect the adoption of ASU 2016-13 to have a material impact on our financial statements and related disclosures. NOTE 2. CASH, CASH EQUIVALENTS AND INVESTMENTS Securities classified as cash, cash equivalents and investments as of June 30, 2021 and December 31, 2020 are summarized below (in thousands): June 30, 2021 Gross Unrealized Amortized Cost Gains Losses Fair Value Cash and cash equivalents: Cash $ 845 $ — $ — $ 845 Money market funds 84,650 — — 84,650 Commercial paper 1,250 — — 1,250 Total cash and cash equivalents 86,745 — — 86,745 Short-term investments Commercial paper $ 62,719 $ 6 $ — $ 62,725 Corporate bonds 16,964 1 ( 1 ) 16,964 Asset-backed securities 5,376 — ( 1 ) 5,375 Total short-term investments 85,059 7 ( 2 ) 85,064 Total cash equivalents and investments $ 171,804 $ 7 $ ( 2 ) $ 171,809 8 Table of Contents December 31, 2020 Gross Unrealized Amortized Cost Gains Losses Fair Value Cash and cash equivalents: Cash $ 781 $ — $ — $ 781 Money market funds 88,151 — — 88,151 Commercial paper 2,100 — — 2,100 Total cash and cash equivalents 91,032 — — 91,032 Short-term investments Commercial paper $ 60,631 $ 2 $ ( 4 ) $ 60,629 Corporate bonds 24,547 3 ( 6 ) 24,544 U.S. government-sponsored agency bonds 9,277 2 — 9,279 U.S. treasury notes 1,000 — — 1,000 Total short-term investments 95,455 7 ( 10 ) 95,452 Long-term investments: Corporate bonds $ 2,115 $ ( 1 ) 2,114 Total cash equivalents and investments $ 188,602 $ 7 $ ( 11 ) $ 188,598 We invest excess cash in marketable securities with high credit ratings. These securities consist primarily of money market funds, commercial paper, corporate bonds, asset-backed securities, and U.S. treasury and agency securities and are classified as “available-for-sale.” All available-for-sale securities held as of June 30, 2021 had contractual maturities of less than one year. Our available-for-sale securities are subject to a periodic impairment review. We consider a debt security to be impaired when the fair value of that security is less than its carrying cost, in which case we would further evaluate the investment to determine whether the security is other-than-temporarily impaired. When we evaluate an investment for other-than-temporary impairment, we review factors such as the length of time and extent to which fair value has been below cost basis, the financial condition or creditworthiness of the issuer and any changes thereto, intent to sell, and whether it is more likely than not we will be required to sell the investment before the recovery of its cost basis. If an investment is other-than-temporarily impaired, we write the investment down through the statement of operations to its fair value and establishes that value as the new cost basis for the investment. Management has determined that none of our available-for-sale securities were other-than-temporarily impaired in any of the periods presented, and as of June 30, 2021, no investment was in a continuous unrealized loss position for more than one year. As such, we believe that it is more likely than not that investments in a loss position will be held until maturity or a forecasted recovery of fair value. NOTE 3. FAIR VALUE MEASUREMENTS Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows: Level 1 – Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. treasuries and trading securities with quoted prices on active markets. Level 2 – Valuations based on inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. treasuries and trading securities with quoted prices on active markets. Level 3 – Valuations based on unobservable inputs for which there is little or no market data, which require us to develop our own assumptions. 9 Table of Contents The following table sets forth the fair value of our financial assets and liabilities that are measured or disclosed on a recurring basis by level within the fair value hierarchy (in thousands): June 30, 2021 Total Fair Value Level 1 Level 2 Level 3 Assets: Money market funds $ 84,650 $ 84,650 $ — $ — Commercial paper 63,975 — 63,975 — Corporate bonds 16,964 — 16,964 — Asset-backed securities 5,375 — 5,375 — Total $ 170,964 $ 84,650 $ 86,314 $ — Liabilities: Derivative liability for Exit Fee $ 663 $ — $ — $ 663 Total $ 663 $ — $ — $ 663 December 31, 2020 Total Fair Value Level 1 Level 2 Level 3 Assets: Money market funds $ 88,151 $ 88,151 $ — $ — Commercial paper 62,729 — 62,729 — Corporate bonds 26,658 — 26,658 — U.S. government-sponsored agency bonds 9,279 — 9,279 — U.S. treasury notes 1,000 — 1,000 — Total $ 187,817 $ 88,151 $ 99,666 $ — Liabilities: Derivative liability for Exit Fee $ 1,376 $ — $ — $ 1,376 Total $ 1,376 $ — $ — $ 1,376 Where quoted prices are available in an active market, securities are classified as Level 1. We classify money market funds as Level 1. When quoted market prices are not available for the specific security, we estimate fair value by using benchmark yields, reported trades, broker/dealer quotes and issuer spreads. We classify U.S. government-sponsored agency bonds, U.S. treasury notes, corporate bonds, commercial paper, asset-backed securities and foreign currency derivative contracts as Level 2. In certain cases, where there is limited activity or less transparency around inputs to valuation, securities or derivative liabilities such as the Exit Fee, as defined and discussed in Note 6, are classified as Level 3. The carrying amounts reflected in the balance sheets for cash equivalents, short-term investments, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values at both June 30, 2021 and December 31, 2020, due to their short-term nature. Fair Value of Debt The interest rate of our term loan facility approximates the rate at which we could obtain alternative financing. Therefore, the carrying amount of the term loan facility approximated its fair value at June 30, 2021 and December 31, 2020. 10 Table of Contents NOTE 4. COLLABORATION AND LICENSING AGREEMENTS Kyowa Kirin Co., Ltd. (“KKC”) 2019 KKC Agreement In November 2019, we entered into a research collaboration and option agreement with KKC (the “2019 KKC Agreement”) for research associated with identifying two preclinical compounds that are ready for designation as development compounds (“DCs”), with one compound inhibiting the first undisclosed target (“Program 1”), and a second inhibiting the second undisclosed target (“Program 2”). Pursuant to the 2019 KKC Agreement, upon completion of the research and designation by the research steering committee of one or more DCs, KKC has the right to execute one or more separate collaborative agreements relating to the development and commercialization of one or both DCs in certain specified territories. Under the terms of the 2019 KKC Agreement, KKC paid us a non-refundable, non-creditable upfront fee of $ 10.0 million in two installments as follows: the first installment of $ 5.0 million within 30 days of November 11, 2019 (the “Effective Date”), and the second installment of $ 5.0 million on the first anniversary of the Effective Date. The term of the 2019 KKC Agreement commenced on the Effective Date and ends on the earliest of: (i) 2 years following the Effective Date, (ii) the nomination of a program DC for both programs, (iii) the nomination of one program DC and the decision by the parties to cease research for the other program, or (iv) the decision by the parties to cease research for both programs. During the three and six months ended June 30, 2021, we recognized $ 1.3 million and $ 2.8 million, respectively, as collaborative development revenue under the 2019 KKC Agreement in the accompanying condensed statement of operations and comprehensive loss. During the three and six months ended June 30, 2020, we recognized $ 1.1 million and $ 2.3 million, respectively, as collaborative development revenue under the 2019 KKC Agreement in the accompanying condensed statement of operations and comprehensive loss. The aggregate amount of the transaction price allocated to our partially unsatisfied performance obligations as of June 30, 2021 and December 31, 2020 was $ 1.4 million and $ 4.2 million, respectively, which is presented in the accompanying condensed balance sheet as deferred revenue. As of June 30, 2021, we expect to recognize the remaining transaction price allocated to our partially unsatisfied performance obligations over the remaining research terms, which is currently expected to extend through the end of 2021. There were no significant changes in estimates associated with the 2019 KKC Agreement during the six months ended June 30, 2021. 2017 KKC Agreement In November 2017, we entered into an exclusive license agreement with KKC (the “2017 KKC Agreement”), for the development, commercialization, and distribution of tenapanor in Japan for cardiorenal indications. We granted KKC an exclusive license to develop and commercialize certain sodium hydrogen exchanger 3 (“NHE3”) inhibitors including tenapanor in Japan for the treatment of cardiorenal diseases and conditions, excluding cancer. We retained the rights to tenapanor outside of Japan, and also retained the rights to tenapanor in Japan for indications other than those stated above. Pursuant to the 2017 KKC Agreement, KKC is responsible for all costs and expenses incurred in the development and commercialization of tenapanor for all licensed indications in Japan. We are responsible for supplying the tenapanor drug substance for KKC’s use in development and commercialization throughout the term of the 2017 KKC Agreement, provided that KKC may exercise an option to manufacture the tenapanor drug substance under certain conditions. We assessed these arrangements in accordance with Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) and related amendments (“ASC 606”) and concluded that the contract counterparty, KKC, is a customer. Under the terms of the 2017 KKC Agreement, we received $ 30.0 million in upfront license fees, which was recognized as revenue when the agreement was executed. Based on our assessment, management determined that the license and the manufacturing supply services were its material performance obligations at the inception of the 2017 KKC Agreement, and as such, each of the performance obligations is distinct. In addition to the up-front license fee received of $ 30.0 million, we may be entitled to receive up to $ 55.0 million in total development milestones, of which $ 10.0 million has been received and recognized as revenue as of June 30, 2021, and approximately ¥ 8.5 billion for commercialization milestones, or approximately $ 76.5 million at the currency exchange rate on June 30, 2021, as well as reimbursement of costs plus a reasonable overhead for the supply of product and high-teen royalties on net sales throughout the term of the agreement. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as these were fully constrained at June 30, 2021. During the three and six months ended June 30, 2021 we recognized zero and $ 5.0 million, respectively, as licensing revenue upon the achievement of development milestones. During the three and six months ended June 30, 2020, we 11 Table of Contents recognized no licensing revenue upon the achievement of development milestones. The $ 5.0 million development milestone recognized during the three months ended March 31, 2021 related to the initiation by KKC of phase 3 clinical studies in Japan to evaluate tenapanor for hyperphosphatemia. During the three and six months ended June 30, 2021, we recognized zero and $ 0.1 million as product supply revenue related to the manufacturing supply of tenapanor and other materials to KKC pursuant to the 2017 KKC Agreement. During the three and six months ended June 30, 2020, we recognized $ 5.0 thousand and $ 43.0 thousand as product supply revenue. During the three and six months ended June 30, 2021 we received a $ 2.9 million prepayment from KKC for the manufacturing of tenapanor drug substance. The prepayment is reflected within prepaid and other current assets and deferred revenue, non-current on our condensed balance sheet as of June 30, 2021. Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (“Fosun Pharma”) In December 2017, we entered into an exclusive license agreement with Fosun Pharma (the “Fosun Agreement”), for the development, commercialization and distribution of tenapanor in China for both hyperphosphatemia and IBS-C. We assessed these arrangements in accordance with ASC 606 and concluded that the contract counterparty, Fosun Pharma, is a customer. Under the terms of the Fosun Agreement, we received $ 12.0 million in upfront license fees which was recognized as revenue when the agreement was executed. Based on management’s assessment, we determined that the license and the manufacturing supply services represented the material performance obligations at the inception of the agreement, and as such, each of the performance obligations is distinct. We may be entitled to additional development and commercialization milestones of up to $ 110.0 million, as well as reimbursement of cost plus a reasonable overhead for the supply of product and tiered royalties on net sales ranging from the mid-teens to 20 %. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as these were fully constrained at June 30, 2021. We have recorded no revenue during the three and six months ended June 30, 2021 related to the Fosun Agreement. Knight Therapeutics, Inc. (“Knight“) In March 2018, we entered into an exclusive license agreement with Knight (the “Knight Agreement”) for the development, commercialization and distribution of tenapanor in Canada for hyperphosphatemia and IBS-C. We assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Knight, is a customer. Based on management’s assessment, we determined that the license and the manufacturing supply services represented the material performance obligations at the inception of the agreement, and as such, each of the performance obligations is distinct. Under the terms of the agreement, we received a $ 2.3 million nonrefundable, one-time upfront payment in March 2018 and are eligible to receive additional development and commercialization milestone payments worth up to $ 17.9 million. We are also eligible to receive royalties throughout the term of the agreement, and a transfer price for manufacturing services. The variable consideration related to the remaining development milestone payments has not been included in the transaction price as they were fully constrained at June 30, 2021. AstraZeneca AB (“AstraZeneca”) In June 2015, we entered into a termination agreement with AstraZeneca (the “AstraZeneca Termination Agreement”) pursuant to which we have agreed to pay AstraZeneca (i) future royalties at a royalty rate of 10 % of net sales of tenapanor or other NHE3 products by us or our licensees, and (ii) 20 % of non-royalty revenue received from a new collaboration partner should we elect to license, or otherwise provide rights to develop and commercialize tenapanor or another NHE3 inhibitor, up to a maximum of $ 75.0 million in aggregate for (i) and (ii). As of June 30, 2021, to date in aggregate, we have recognized $ 11.6 million of the $ 75.0 million, which has been recorded as cost of revenue, and have paid AstraZeneca $ 10.6 million. For the three and six months ended June 30, 2021 we recognized and recorded as cost of revenue zero and $ 1.0 million related to the AstraZeneca Termination Agreement. For the three and six months ended June 30, 2020 we recognized $ 0.1 million cost of revenue related to the AstraZeneca Termination Agreement. 12 Table of Contents Deferred Revenue The following tables present changes in our current and non-current deferred revenue balances during the reporting period. The current deferred revenue balance is attributable entirely to the 2019 KKC Agreement and the non-current deferred revenue balance is attributable entirely to the 2017 KKC Agreement (in thousands): Deferred revenue - current Balance at December 31, 2020 $ 4,177 Decreases due to revenue recognized in the period for which cash has been received ( 2,765 ) Balance at June 30, 2021 $ 1,412 Deferred revenue - non-current Balance at December 31, 2020 $ — Increases to amounts invoiced for which cash has been received 2,947 Balance at June 30, 2021 $ 2,947 NOTE 5. BORROWING Solar Capital and Western Alliance Bank Loan Agreement On May 16, 2018, we entered into a loan and security agreement (the “Loan Agreement”), with Solar Capital Ltd. and Western Alliance Bank (collectively the “Lenders”). The Loan Agreement provides for a $ 50.0 million term loan facility with a maturity date of November 1, 2022 (the “Term Loan”). On October 9, 2020, we and the Lenders entered into an amendment to the Loan Agreement (“the 2020 Amendment”) to extend the date through which we are permitted to make interest-only payments on the Term Loan by twelve months to December 1, 2021. The 2020 amendment also required that if either the FDA does not approve our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis on or before May 31, 2021 or the FDA issues a CRL with respect to our NDA Number 213931, then we are to begin principal payments on the earlier of June 1, 2021 or the first day of the month immediately following the date that the FDA issues us a CRL. On April 29, 2021, the FDA extended the Prescription Drug User Fee Act ("PDUFA") date for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis by three months to July 29, 2021, making it unlikely that the FDA would approve our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis on or before May 31, 2021. In May and July 2021, we and the Lenders entered into additional amendments to the Loan Agreement (“the 2021 Amendments”) which together extended the period of time that we are permitted to make interest-only payments on the Term Loan to December 1, 2021; provided that if we have not received FDA approval for our NDA for tenapanor for the control of serum phosphorus in adult patients with CDK on dialysis on or before October 25, 2021, the interest-only period will expire and principal repayments shall be required to begin on November 1, 2021. If principal repayments are required to begin prior to December 1, 2021 under the 2021 Amendments, then the first such repayment shall include all payments that would have been due if monthly principal repayment had begun on June 1, 2021. As of June 30, 2021, we have classified our loan payable, current to include all principal payments that would have been due beginning on June 1, 2021. We paid a closing fee of 1 % of the Term Loan, or $ 0.5 million, upon the closing of the Term Loan, $ 0.1 million upon closing of the 2020 Amendment and $ 0.1 million upon closing of the 2021 Amendments. Under the Term Loan, we are also obligated to pay a final fee equal to 4.95 % of the Term Loan upon the earliest to occur of the maturity date, the acceleration of the Term Loan, the prepayment or repayment of the Term Loan or the termination of the Loan Agreement. We may voluntarily prepay the outstanding Term Loan, subject to a prepayment premium of (i) 3 % of the principal amount of the Term Loan if prepaid prior to or on the first anniversary of the Closing Date, (ii) 2 % of the principal amount of the Term Loan if prepaid after the first anniversary of the Closing Date through and including the second anniversary of the Closing Date, or (iii) 1 % of the principal amount of the Term Loan if prepaid after the second anniversary of the Closing Date and prior to the maturity date. The Term Loan is secured by substantially all our assets, except for our intellectual property and certain other customary exclusions. Additionally, in connection with the Term Loan, we entered into the Exit Fee Agreement, as discussed in Note 6. The Loan Agreement also contains customary events of default that entitle the Lender to cause us indebtedness under the Loan Agreement to become immediately due and payable, and to exercise remedies against us and the collateral securing the 13 Table of Contents Term Loan, including our cash. Upon the occurrence and for the duration of an event of default, an additional default interest rate equal to 4 % per annum will apply to all amounts owed under the Loan Agreement. As of June 30, 2021, to our knowledge, there were no facts or circumstances in existence that would give rise to an event of default. As of June 30, 2021, our future payment obligations related to the Term Loan, excluding interest payments and the Exit Fee, are as follows (in thousands): Total repayment obligations $ 52,475 Less: Unamortized discount and debt issuance costs ( 378 ) Less: Unaccreted value of final fee ( 853 ) Loan payable 51,244 Less: Loan payable, current portion ( 36,111 ) Loan payable, net of current portion $ 15,133 NOTE 6. DERIVATIVE LIABILITY Exit Fee In May 2018, in connection with entering into the Loan Agreement, as defined and discussed in Note 5, we entered into an agreement pursuant to which we agreed to pay $ 1.5 million in cash (the “Exit Fee”) upon any change of control transaction in respect of the Company or if we obtain both (i) FDA approval of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis and (ii) FDA approval of tenapanor for the treatment of patients with irritable bowel syndrome with constipation (“IBS-C”), which was obtained on September 12, 2019 when the FDA approved IBSRELA® (tenapanor), a 50 milligram, twice daily oral pill for the treatment of IBS-C in adults (the “Exit Fee Agreement”). Notwithstanding the prepayment or termination of the Term Loan, as defined and discussed in Note 5, our obligation to pay the Exit Fee will expire on May 16, 2028. We concluded that the Exit Fee is a freestanding derivative which should be accounted for at fair value on a recurring basis. The estimated fair value of the Exit Fee is recorded as a derivative liability and included in accrued expenses and other current liabilities on the accompanying condensed balance sheets. The fair value of the derivative liability was determined using a discounted cash flow analysis and is classified as a Level 3 measurement within the fair value hierarchy since our valuation utilized significant unobservable inputs. Specifically, the key assumptions included in the calculation of the estimated fair value of the derivative liability include: (i) our estimates of both the probability and timing of a potential $ 1.5 million payment to Solar Capital Ltd. and Western Alliance Bank as a result of the FDA approvals and (ii) a discount rate which was derived from our estimated cost of debt, adjusted with current LIBOR (or a comparable successor rate if LIBOR no longer exists). Generally, increases or decreases in the probability of occurrence would result in a directionally similar impact in the fair value measurement of the derivative liability and it is estimated that a 10 % increase (decrease), not to exceed 100%, in the probability of occurrence would result in a fair value fluctuation of no more than $ 0.1 million. Changes in the fair value of recurring measurements included in Level 3 of the fair value hierarchy are presented as other income, net in our statements of operations and were as follows for the six months ended June 30, 2021 and 2020 (in thousands): Six Months Ended June 30, 2021 2020 Fair value of Exit Fee derivative liability at January 1 $ 1,376 $ 969 Change in estimated fair value of derivative liability ( 713 ) 152 Fair value of Exit Fee derivative liability at June 30 $ 663 $ 1,121 During the three months ended June 30, 2021 we reduced the value of the derivative liability due the receipt of the CRL from the FDA regarding our NDA for the control of serum phosphorus in adult patients with CKD on dialysis. 14 Table of Contents NOTE 7. LEASES All of our leases are operating leases and each contain customary rent escalation clauses. Certain of the leases have both lease and non-lease components. We have elected to account for each separate lease component and the non-lease components associated with that lease component as a single lease component for all classes of underlying assets. During the six months ended June 30, 2021, we entered into an amendment to the lease for our Fremont, California facility that extended the term of the lease to March 2025. The office space consists of 72,500 square feet with the lease terminating in September 2025. We increased the right-of-use asset and lease liability by $ 11.9 million for the Fremont lease upon commencement of the amendment. During the six months ended June 30, 2021, we recorded a right-of-use operating lease asset for a new facility in Waltham, Massachusetts under a lease agreement entered into during December 2020 with lease commencement dates during April and May 2021. The office space consists of 12,864 square feet with the lease terminating in June 2026. We have an option to extend the lease term for one additional five year period. This option to extend the lease term has not been included in the calculation since currently the exercise of the option is uncertain and therefore deemed not probable. We recorded a $ 1.6 million right-of-use asset and lease liability for the Waltham lease upon commencement of the lease. The following table provides additional details of our facility leases presented in the condensed balance sheet as of June 30, 2021 (dollars in thousands): Facilities Right-of-use assets $ 14,519 Current portion of lease liabilities 3,184 Operating lease liability, net of current portion 11,548 Total $ 14,732 Weighted-average remaining life (years) 3.90 Weighted-average discount rate 6.87 % Lease costs, which are included in operating expenses in our statements of operations, were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Operating lease expense $ 837 $ 648 $ 1,510 $ 1,296 Cash paid for operating leases $ 766 $ 761 $ 1,554 $ 1,521 The following table summarizes our undiscounted cash payment obligations for our operating lease liabilities as of June 30, 2021 (in thousands): Remainder of 2021 $ 1,978 2022 4,292 2023 4,440 2024 4,589 2025 1,321 Thereafter 252 Total undiscounted operating lease payments 16,872 Imputed interest expenses ( 2,140 ) Total operating lease liabilities 14,732 Less: Current portion of operating lease liability ( 3,184 ) Operating lease liability, net of current portion $ 11,548 15 Table of Contents NOTE 8. STOCKHOLDERS’ EQUITY At the Market Offerings Agreement In July 2020, we filed a Form S-3 registration statement, which became effective in August 2020, containing (i) a base prospectus for the offering, issuance and sale by us of up to a maximum aggregate offering price of $ 250.0 million of our common stock, preferred stock, debt securities, warrants and/or units, from time to time in one or more offerings; and (ii) a prospectus supplement for the offering, issuance and sale by us of up to a maximum aggregate offering price of $ 100.0 million of our common stock that may be issued and sold, from time to time, under a sales agreement with Jefferies LLC, deemed to be “at the market offerings.” During the six months ended June 30, 2021 we sold 9.0 million shares of our common stock for aggregate gross proceeds of $ 63.8 million at a weighted average price of $ 7.10 per share under the Open Market Sales Agreement. We sold 8.2 million shares of our common stock between the dates of November 13, 2020 through February 19, 2021 and 4.0 million shares between the dates of May 11, 2021 through June 18, 2021 for a cumulative total of 12.2 million shares and gross proceeds of $ 85.4 million at a weighted average sales price of approximately $ 6.98 per share during the life of the Open Market Sales Agreement. Pursuant to the Open Market Sales Agreement, Jefferies, as our sales agent, receives a commission of up to 3.0 % of the gross sales price for shares of common stock sold under the Open Market Sales Agreement. NOTE 9. EQUITY INCENTIVE PLANS Stock-Based Compensation Stock-based compensation expense recognized for stock options, restricted stock units ("RSUs"), performance-based restricted stock units ("PRSUs") and our employee stock purchase program (the "ESPP") are recorded as operating expenses in our condensed statements of operations and comprehensive loss, as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 1,087 $ 1,144 $ 2,179 $ 2,202 General and administrative 2,132 1,530 4,127 3,420 Total $ 3,219 $ 2,674 $ 6,306 $ 5,622 As of June 30, 2021, our total unrecognized stock-based compensation expense, net of estimated forfeitures, and average remaining vesting period, included the following (dollars in thousands): Unrecognized Compensation Expense Average Remaining Vesting Period (Years) Stock options $ 25,267 2.8 RSUs $ 6,978 3.6 ESPP $ 151 0.2 Stock Options A summary of our stock option activity and related information for the six months ended June 30, 2021 is as follows (in thousands, except dollar amounts): Number of Shares Weighted Average Exercise Price Outstanding balance at December 31, 2020 9,790 $ 6.76 Granted 3,328 $ 6.62 Exercised ( 205 ) $ 2.75 Forfeited ( 401 ) $ 7.56 Outstanding balance at June 30, 2021 12,511 $ 6.76 Exercisable at June 30, 2021 6,043 $ 7.38 16 Table of Contents Restricted Stock Units A summary of our RSUs activity and related information for the six months ended June 30, 2021 is as follows (in thousands, except dollar amounts): Number of RSUs Weighted Average Value at Grant Outstanding balance at December 31, 2020 159 $ 5.64 Granted 1,088 $ 6.62 Vested ( 80 ) $ 6.43 Forfeited ( 32 ) $ 6.10 Unvested at June 30, 2021 1,135 $ 6.52 We issued no PRSUs during the six months ended June 30, 2021 and we have no PRSUs outstanding as of June 30, 2021. Employee Stock Purchase Plan In February 2021, we sold approximately 0.2 million shares of our common stock under the ESPP. The shares were purchased by employees at a purchase price of $ 5.84 per share resulting in proceeds to us of approximately $ 1.4 million. Issuance of Common Stock for Services Under Our Amended and Restated Non-Employee Director Compensation Program, members of our board of directors may elect to receive shares of our stock in lieu of their cash fees. During the six months ended June 30, 2021, we issued no shares of our common stock to members of the board of directors in accordance with the program. NOTE 10. NET LOSS PER SHARE Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, less shares subject to repurchase, and excludes any dilutive effects of stock-based awards and warrants. Diluted net loss per common share is computed giving effect to all potential dilutive common shares, including common stock issuable upon exercise of stock options, and unvested restricted common stock and stock units. As we had net losses for the three and six months ended June 30, 2021 and 2020, all potential common shares were determined to be anti-dilutive. The following table sets forth the computation of net loss per common share (in thousands, except per share amounts): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator: Net loss $ ( 45,189 ) $ ( 24,956 ) $ ( 78,344 ) $ ( 47,329 ) Denominator: Weighted average common shares outstanding - basic and diluted 100,040 89,080 98,618 88,890 Net loss per share - basic and diluted $ ( 0.45 ) $ ( 0.28 ) $ ( 0.79 ) $ ( 0.53 ) For the three and six months ended June 30, 2021, the total number of securities that could potentially dilute basic net loss per share in the future that were not included in the computation of diluted net loss per share because the effect would have been antidilutive was 13.8 million and 13.4 million, respectively. For the three and six months ended June 30, 2020, the total number of securities that could potentially dilute basic net loss per share in the future that were not included in the computation of diluted net loss per share because the effect would have been antidilutive was 11.5 million and 11.7 million, respectively. 17 Table of Contents NOTE 11. CONTINGENCIES From time to time we may be involved in claims arising in connection with our business. Based on information currently available, management believes that the amount, or range, of reasonably possible losses in connection with any pending actions against us would not be material to our financial condition or cash flows, and no contingent liabilities were accrued as of June 30, 2021 or 2020. NOTE 12. SUBSEQUENT EVENTS On July 28, 2021, we received a CRL from the FDA regarding our NDA for the control of serum phosphorus in adult patients with CKD on dialysis. According to the CRL, while the FDA agrees “that the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis,” the FDA characterizes the magnitude of the treatment effect as “small and of unclear clinical significance.” Additionally, the FDA noted that for the application to be approved, we will need “to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect on serum phosphorus or an effect on the clinical outcome thought to be caused by hyperphosphatemia in CKD patients on dialysis.” There were no safety, clinical pharmacology/biopharmaceutics, chemistry, manufacturing, and controls or non-clinical issues identified in the CRL. We intend to request a Type A meeting as soon as possible to discuss the CRL and determine potential paths forward for the approval of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. On July 29, 2021, we entered into a Fourth Amendment to the Loan Agreement (the “Amendment”) which extended the period of time that we are permitted to make interest-only payments on the Term Loan to December 1, 2021; provided that if we have not received FDA approval for our NDA for tenapanor for the control of serum phosphorus in adult patients with CDK on dialysis on or before October 25, 2021, the interest-only period will expire and principal repayments shall be required to begin on November 1, 2021. If principal repayments are required to begin prior to December 1, 2021 under the 2021 Amendments, then the first such repayment shall include all payments that would have been due if monthly principal repayment had begun on June 1, 2021. On July 29, 2021, our Board of Directors approved, and on August 2, 2021 we began implementing, a restructuring plan to better align our workforce and anticipated commercial and development spend with our capital resources and the needs of our business following the receipt of the CRL. The restructuring plan is expected to be completed in August 2021. Under the restructuring plan, we are reducing our workforce by approximately 83 employees (approximately 33 %). Impacted employees will receive cash payments equal to their base pay for a notice period of sixty ( 60 ) days and Company funded COBRA premiums through such notice period. In addition, impacted employees are eligible to receive severance benefits and additional Company funded COBRA premiums, contingent upon an impacted employee’s execution (and non-revocation) of a separation agreement, which includes a general release of claims against the Company. We expect that the workforce reduction will decrease our annual cash compensation costs by approximately $ 17 million. In connection with the restructuring, we estimate that we will incur restructuring charges of approximately $ 3.4 million, which will be recorded primarily in the third quarter of 2021, related to one-time termination notice and severance payments and other employee-related costs. The cash payments related to the reduction in workforce will be paid primarily during the third quarter of 2021. We may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the reduction in workforce. On July 30, 2021, a putative securities class action lawsuit was commenced in the U.S. District Court for the Northern District of California naming as defendants Ardelyx and two current officers. The complaint alleges that the defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material fact related to tenapanor. The plaintiff seeks to represent all persons who purchased or otherwise acquired Ardelyx securities between August 6, 2020, and July 19, 2021. The plaintiff seeks damages and interest, and an award of costs, including attorneys’ fees. We believe the plaintiff’s claims are without merit and we have not recorded any accrual for a contingent liability associated with these legal proceedings.