Ardelyx(ARDX)

Search documents
Ardelyx(ARDX) - 2025 Q2 - Earnings Call Transcript
2025-08-04 21:30
Financial Data and Key Metrics Changes - The company reported total revenue of $97.7 million for Q2 2025, representing a 33% year-over-year growth compared to $73.2 million in Q2 2024 [25] - The net loss for Q2 2025 was approximately $19.1 million, or $0.08 per share, compared to a net loss of $16.5 million, or $0.07 per share in the same period last year [31] - The company ended Q2 2025 with $238.5 million in cash, cash equivalents, and short-term investments, including $48.7 million of incremental debt [32] Business Line Data and Key Metrics Changes - Ibsrela generated $65 million in net sales revenue for Q2 2025, reflecting an 84% year-over-year growth and a 46% quarter-over-quarter growth [6][11] - Exposa recorded net sales revenue of $25 million in Q2 2025, a 7% increase compared to Q1 2025, and a 27% increase when excluding a one-time reserve release from Q1 [7][28] Market Data and Key Metrics Changes - The demand for Ibsrela in Israel showed broad-based growth with record highs across all key indicators, leading to an increase in full-year guidance for net sales revenue to $250 million to $260 million [6] - Exposa's performance was driven by improved access for patients and growth in non-Medicare payer segments, indicating a positive response to promotional messaging from the sales team [18][19] Company Strategy and Development Direction - The company is focused on executing its commercial strategy effectively, with plans to continue expanding the prescribing base for both Ibsrela and Exposa [15][21] - The leadership team has been strengthened with new appointments to support the next phase of growth, including the promotion of Mike Kelleher to Chief Business Officer [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving peak sales of over $1 billion for Ibsrela and $750 million for Exposa, citing strong patient demand and improved prescription pull-through [16][21] - The company is optimistic about continued growth throughout 2025, with a focus on maintaining high execution levels [21] Other Important Information - The company has drawn an additional $50 million of debt to enhance financial flexibility, bringing total outstanding debt to $200 million [32] - The company has completed its $75 million royalty obligation to AstraZeneca, which is now behind them [30] Q&A Session Summary Question: Update on potential EU partner and cash flow positive status - Management indicated that achieving cash flow breakeven is a near-term goal and that they are evaluating opportunities in Europe [38] Question: Clarification on new guidance for Ibsrela - Management stated that the $10 million increase in guidance reflects a meaningful step forward and is based on thoughtful analysis [44] Question: Sales growth attribution to expanded sales team - Management confirmed that the expanded sales team has significantly contributed to the increase in prescriptions and expects this trend to continue [50][52] Question: Contribution from transitional scripts for Exposa - Management noted that there was an inconsequential amount of transitional scripts in Q2 and that the mix is roughly 50/50 between Medicaid and commercial [60][118] Question: Confidence in new peak estimate for Exposa - Management expressed confidence in the new peak estimate for Exposa, citing a total available market of 220,000 patients and strong performance indicators [86] Question: Update on CMS legal proceedings - Management confirmed that arguments for the ongoing CMS case will be heard on September 25, with no statutory requirement for a response timeframe [79]
Ardelyx(ARDX) - 2025 Q2 - Quarterly Report
2025-08-04 20:41
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-3648 ...
Ardelyx(ARDX) - 2025 Q2 - Quarterly Results
2025-08-04 20:22
[ARTICLE I - CORPORATE OFFICES](index=6&type=section&id=ARTICLE%20I%20-%20CORPORATE%20OFFICES) This article defines the Corporation's registered and other corporate office locations and the Board's authority to establish them [1.1 REGISTERED OFFICE](index=6&type=section&id=1.1%20REGISTERED%20OFFICE) This section specifies that the Corporation's registered office is established in its certificate of incorporation - The registered office of Ardelyx, Inc. is **fixed in the Corporation's certificate of incorporation**[6](index=6&type=chunk) [1.2 OTHER OFFICES](index=6&type=section&id=1.2%20OTHER%20OFFICES) This section grants the Board of Directors the authority to establish additional corporate offices - The Board of Directors may **establish other offices** at any place where the Corporation is qualified to do business[7](index=7&type=chunk) [ARTICLE II - MEETINGS OF STOCKHOLDERS](index=6&type=section&id=ARTICLE%20II%20-%20MEETINGS%20OF%20STOCKHOLDERS) This article details the procedures for stockholder meetings, including scheduling, notice, quorum, voting, and director nominations [2.1 PLACE OF MEETINGS](index=6&type=section&id=2.1%20PLACE%20OF%20MEETINGS) This section outlines the permissible locations for stockholder meetings, including remote communication options - Stockholder meetings can be held within or outside Delaware, or solely by **remote communication** as authorized by DGCL Section 211(a)(2), as designated by the Board[9](index=9&type=chunk) [2.2 ANNUAL MEETING](index=6&type=section&id=2.2%20ANNUAL%20MEETING) This section details the scheduling and permissible business for the annual stockholder meeting - The Board designates the date and time of the annual meeting, where directors are elected and other proper business (in accordance with Section 2.4) may be transacted[10](index=10&type=chunk) - The Board has the authority to **postpone, reschedule, or cancel** any previously scheduled annual meeting[10](index=10&type=chunk) [2.3 SPECIAL MEETING](index=6&type=section&id=2.3%20SPECIAL%20MEETING) This section specifies who can call special stockholder meetings and limits the business that can be conducted - Special meetings of stockholders may only be called by persons and in the manner set forth in the **certificate of incorporation**[11](index=11&type=chunk) - Only business specified in the meeting notice may be transacted at a special meeting[11](index=11&type=chunk) [2.4 ADVANCE NOTICE PROCEDURES FOR BUSINESS BROUGHT BEFORE A MEETING](index=6&type=section&id=2.4%20ADVANCE%20NOTICE%20PROCEDURES%20FOR%20BUSINESS%20BROUGHT%20BEFORE%20A%20MEETING) This section establishes the strict procedures and deadlines for stockholders to propose business at annual meetings, requiring timely and detailed notice - Stockholders must provide '**Timely Notice**' in writing to the Secretary, generally **90-120 days** prior to the one-year anniversary of the preceding year's annual meeting[14](index=14&type=chunk) - The notice must include '**Stockholder Information**' (name, address, share ownership, investment intent) and '**Disclosable Interests**' (derivative securities, legal proceedings, material relationships, proxy solicitation intent)[15](index=15&type=chunk)[16](index=16&type=chunk)[17](index=17&type=chunk) - Only business properly brought before the annual meeting in accordance with these procedures, or specified by the Board, may be conducted[12](index=12&type=chunk)[22](index=22&type=chunk) [2.5 ADVANCE NOTICE PROCEDURES FOR NOMINATIONS OF DIRECTORS](index=10&type=section&id=2.5%20ADVANCE%20NOTICE%20PROCEDURES%20FOR%20NOMINATIONS%20OF%20DIRECTORS) This section outlines the specific advance notice requirements and information disclosures for stockholders nominating directors for election at annual or special meetings - For annual meetings, nominations require '**Timely Notice**' (as defined in Section 2.4); for special meetings, notice must be **90-120 days** prior, or **10 days** after public disclosure of the meeting date[27](index=27&type=chunk)[29](index=29&type=chunk) - Nominating Persons must provide '**Stockholder Information**', '**Disclosable Interests**', and '**Nominee Information**' (including consent to serve, background, qualifications, and compliance with corporate policies)[32](index=32&type=chunk)[33](index=33&type=chunk)[38](index=38&type=chunk) - Nominating Persons soliciting proxies must comply with **Rule 14a-19** under the Exchange Act, including timely notice and evidence of compliance[36](index=36&type=chunk)[37](index=37&type=chunk) [2.6 NOTICE OF STOCKHOLDERS' MEETINGS](index=14&type=section&id=2.6%20NOTICE%20OF%20STOCKHOLDERS'%20MEETINGS) This section specifies the timeframe and content requirements for notices of stockholder meetings - Notice of any stockholder meeting must be given not less than **10 nor more than 60 days** before the meeting date[44](index=44&type=chunk) - The notice must specify the place, date, time, means of remote communication (if any), and for special meetings, the purpose(s)[44](index=44&type=chunk) [2.7 QUORUM](index=14&type=section&id=2.7%20QUORUM) This section defines what constitutes a quorum for stockholder meetings and the procedures if a quorum is not present - A **majority in voting power** of the stock issued, outstanding, and entitled to vote (present in person, by remote communication, or by proxy) constitutes a quorum[45](index=45&type=chunk) - If a quorum is not present, the chairperson or a majority of voting stockholders may **adjourn the meeting** until a quorum is present[45](index=45&type=chunk) [2.8 ADJOURNED MEETING; NOTICE](index=14&type=section&id=2.8%20ADJOURNED%20MEETING%3B%20NOTICE) This section details the notice requirements for adjourned stockholder meetings - Notice of an adjourned meeting is generally **not required** if the new time, place, and remote communication means are announced at the original meeting[46](index=46&type=chunk) - If an adjournment is for **more than 30 days**, or if a new record date is fixed, notice of the adjourned meeting must be given[47](index=47&type=chunk) [2.9 CONDUCT OF BUSINESS](index=15&type=section&id=2.9%20CONDUCT%20OF%20BUSINESS) This section grants the chairperson of a stockholder meeting the authority to determine the order and procedure of business - The chairperson of any stockholder meeting **determines the order of business** and meeting procedures, including voting conduct[48](index=48&type=chunk) [2.10 VOTING](index=15&type=section&id=2.10%20VOTING) This section defines voting rights and the vote required for director elections and other matters - Each stockholder is entitled to **one vote per share** of capital stock, unless otherwise provided by DGCL, certificate of incorporation, or bylaws[50](index=50&type=chunk) - Directors are elected by a **plurality of votes cast**; other matters are decided by a majority of votes cast (excluding abstentions and broker non-votes), unless otherwise specified[51](index=51&type=chunk) [2.11 STOCKHOLDER ACTION BY WRITTEN CONSENT WITHOUT A MEETING](index=15&type=section&id=2.11%20STOCKHOLDER%20ACTION%20BY%20WRITTEN%20CONSENT%20WITHOUT%20A%20MEETING) This section generally prohibits stockholder action by written consent, requiring actions to be taken at duly called meetings - Any action required or permitted to be taken by stockholders must be effected at a duly called annual or special meeting and **cannot be effected by written consent**, except as provided in the certificate of incorporation or for preferred stock holders[52](index=52&type=chunk) [2.12 RECORD DATE FOR STOCKHOLDER NOTICE; VOTING; GIVING CONSENTS](index=15&type=section&id=2.12%20RECORD%20DATE%20FOR%20STOCKHOLDER%20NOTICE%3B%20VOTING%3B%20GIVING%20CONSENTS) This section outlines the Board's authority to fix record dates for determining stockholders entitled to notice, vote, or receive distributions - The Board may fix a record date for stockholder meetings, which must be **10-60 days** before the meeting date[53](index=53&type=chunk) - A record date may also be fixed for determining stockholders entitled to dividends or other distributions, not more than **60 days** prior to such action[57](index=57&type=chunk) [2.13 PROXIES](index=16&type=section&id=2.13%20PROXIES) This section details the rules for stockholder proxies, including authorization, validity period, and form - Stockholders may authorize proxies in writing or by permitted electronic transmission, valid for up to **three years** unless a longer period is specified[58](index=58&type=chunk) - Stockholders soliciting proxies must use a proxy card color other than white, which is **reserved for the Board**[58](index=58&type=chunk) [2.14 LIST OF STOCKHOLDERS ENTITLED TO VOTE](index=16&type=section&id=2.14%20LIST%20OF%20STOCKHOLDERS%20ENTITLED%20TO%20VOTE) This section mandates the Corporation to prepare and make available a list of stockholders entitled to vote before each meeting - The Corporation must prepare a complete list of voting stockholders at least **10 days** before each meeting, showing names, addresses, and share numbers[59](index=59&type=chunk) - This list must be open for examination by any stockholder for purposes germane to the meeting, either electronically or at the principal executive office[59](index=59&type=chunk) [2.15 INSPECTORS OF ELECTION](index=17&type=section&id=2.15%20INSPECTORS%20OF%20ELECTION) This section outlines the appointment and duties of inspectors of election for stockholder meetings - The Corporation must appoint inspectors of election to ascertain shares, determine validity of proxies/ballots, count votes, and certify results[61](index=61&type=chunk)[62](index=62&type=chunk) - Inspectors must take an oath to **faithfully and impartially** execute their duties[63](index=63&type=chunk) [2.16 DELIVERY TO THE CORPORATION](index=17&type=section&id=2.16%20DELIVERY%20TO%20THE%20CORPORATION) This section specifies the exclusive method for delivering documents and information to the Corporation under Article II - Documents and information required by Article II must be delivered in writing exclusively by **hand (including courier) or certified/registered mail**, return receipt requested[64](index=64&type=chunk) - The Corporation expressly **opts out of DGCL Section 116** for delivery of information under Article II[64](index=64&type=chunk) [ARTICLE III - DIRECTORS](index=17&type=section&id=ARTICLE%20III%20-%20DIRECTORS) This article outlines the powers, election, terms, meetings, and compensation of the Board of Directors [3.1 POWERS](index=18&type=section&id=3.1%20POWERS) This section defines the general powers and responsibilities of the Board of Directors in managing the Corporation's business - The business and affairs of the Corporation shall be **managed by or under the direction of the Board**, subject to DGCL and corporate documents[66](index=66&type=chunk) [3.2 NUMBER OF DIRECTORS](index=18&type=section&id=3.2%20NUMBER%20OF%20DIRECTORS) This section addresses the determination of the number of directors on the Board - The total number of directors is determined by **Board resolution**, with a minimum of one member[67](index=67&type=chunk) - A reduction in the authorized number of directors does not remove any director before their term expires[67](index=67&type=chunk) [3.3 ELECTION, QUALIFICATION AND TERM OF OFFICE OF DIRECTORS](index=18&type=section&id=3.3%20ELECTION%2C%20QUALIFICATION%20AND%20TERM%20OF%20OFFICE%20OF%20DIRECTORS) This section outlines the election, qualifications, and term of office for directors - Each director holds office until their class term expires, their successor is elected and qualified, or until earlier death, resignation, disqualification, or removal[68](index=68&type=chunk) - Directors need not be stockholders unless required by the certificate of incorporation or bylaws[68](index=68&type=chunk) - If provided in the certificate of incorporation, directors may be divided into **three classes**[69](index=69&type=chunk) [3.4 RESIGNATION AND VACANCIES](index=18&type=section&id=3.4%20RESIGNATION%20AND%20VACANCIES) This section details the process for director resignations and how vacancies on the Board are filled - Directors may resign upon written or electronic notice, effective at the specified time or upon receipt[70](index=70&type=chunk) - Vacancies and newly created directorships are filled by a **majority of the directors then in office**, even if less than a quorum, or by a sole remaining director[71](index=71&type=chunk) [3.5 PLACE OF MEETINGS; MEETINGS BY TELEPHONE](index=18&type=section&id=3.5%20PLACE%20OF%20MEETINGS%3B%20MEETINGS%20BY%20TELEPHONE) This section specifies where Board meetings can be held and permits participation via telecommunication - Board meetings can be held **within or outside Delaware**[72](index=72&type=chunk) - Directors may participate in meetings via conference telephone or other communication equipment allowing all participants to hear each other, which constitutes presence in person[73](index=73&type=chunk) [3.6 REGULAR MEETINGS](index=19&type=section&id=3.6%20REGULAR%20MEETINGS) This section addresses the scheduling and notice for regular Board meetings - Regular Board meetings are held at times and places designated by the Board and publicized among all directors; **no further notice is required**[74](index=74&type=chunk) [3.7 SPECIAL MEETINGS; NOTICE](index=19&type=section&id=3.7%20SPECIAL%20MEETINGS%3B%20NOTICE) This section outlines who can call special Board meetings and the required notice procedures - Special Board meetings can be called by the chairperson, CEO, president, secretary, or a **majority of directors**[75](index=75&type=chunk) - Notice of special meetings must be delivered personally, by courier, telephone, or electronic mail at least **24 hours in advance**, or by U.S. mail at least **4 days in advance**[75](index=75&type=chunk)[76](index=76&type=chunk) [3.8 QUORUM](index=19&type=section&id=3.8%20QUORUM) This section defines the quorum for Board meetings and the voting threshold for Board actions - A **majority of the total number of directors** constitutes a quorum for Board meetings[77](index=77&type=chunk) - The vote of a majority of directors present at a meeting with a quorum is considered the act of the Board[77](index=77&type=chunk) [3.9 BOARD ACTION BY WRITTEN CONSENT WITHOUT A MEETING](index=19&type=section&id=3.9%20BOARD%20ACTION%20BY%20WRITTEN%20CONSENT%20WITHOUT%20A%20MEETING) This section permits the Board or its committees to take action by unanimous written or electronic consent without a formal meeting - Any action required or permitted at a Board or committee meeting may be taken without a meeting if **all members consent in writing or by electronic transmission**[78](index=78&type=chunk) - Such action by written consent has the same force and effect as a unanimous vote of the Board[78](index=78&type=chunk) [3.10 FEES AND COMPENSATION OF DIRECTORS](index=20&type=section&id=3.10%20FEES%20AND%20COMPENSATION%20OF%20DIRECTORS) This section grants the Board the authority to determine director compensation - The Board has the authority to **fix the compensation**, including fees and expense reimbursement, for directors' services[79](index=79&type=chunk) [3.11 REMOVAL OF DIRECTORS](index=20&type=section&id=3.11%20REMOVAL%20OF%20DIRECTORS) This section specifies the conditions and voting requirements for the removal of directors - Directors may be removed only **for cause** by the affirmative vote of at least **66-2/3%** of the voting power of all outstanding voting stock[80](index=80&type=chunk) - A reduction in the authorized number of directors does not remove any director prior to the expiration of their term[81](index=81&type=chunk) [ARTICLE IV - COMMITTEES](index=20&type=section&id=ARTICLE%20IV%20-%20COMMITTEES) This article authorizes the Board to establish committees, defining their powers, limitations, and meeting protocols [4.1 COMMITTEES OF DIRECTORS](index=20&type=section&id=4.1%20COMMITTEES%20OF%20DIRECTORS) This section authorizes the Board to designate committees and outlines their powers and limitations - The Board may designate one or more committees, each consisting of one or more directors, with powers and authority of the Board in managing corporate affairs[83](index=83&type=chunk) - Committees cannot approve actions requiring stockholder approval or adopt, amend, or repeal any bylaw[83](index=83&type=chunk) [4.2 COMMITTEE MINUTES](index=20&type=section&id=4.2%20COMMITTEE%20MINUTES) This section requires committees to maintain minutes of their meetings - Each committee must keep regular minutes of its meetings and report them to the Board when required[84](index=84&type=chunk) [4.3 MEETINGS AND ACTION OF COMMITTEES](index=20&type=section&id=4.3%20MEETINGS%20AND%20ACTION%20OF%20COMMITTEES) This section specifies that committee meetings and actions are governed by the same rules as Board meetings, with some committee-specific adjustments - Committee meetings and actions are governed by the same provisions as Board meetings (e.g., place, notice, written consent), with contextual changes[85](index=85&type=chunk)[86](index=86&type=chunk) - The Board may adopt specific rules for committee governance that override general provisions, provided they comply with the certificate of incorporation or law[86](index=86&type=chunk) [ARTICLE V - OFFICERS](index=21&type=section&id=ARTICLE%20V%20-%20OFFICERS) This article specifies the appointment, removal, duties, and compensation of the Corporation's officers [5.1 OFFICERS](index=21&type=section&id=5.1%20OFFICERS) This section lists the required and optional officers of the Corporation and notes that multiple offices can be held by one person - The Corporation must have a **chief executive officer, president, and secretary**; other officers are optional at the Board's discretion[88](index=88&type=chunk) - Any number of offices may be held by the same person, and officers need not be stockholders[88](index=88&type=chunk) [5.2 APPOINTMENT OF OFFICERS](index=21&type=section&id=5.2%20APPOINTMENT%20OF%20OFFICERS) This section states that the Board is responsible for appointing the Corporation's officers - The Board shall appoint the officers of the Corporation, except for those appointed under Section 5.3[89](index=89&type=chunk) [5.3 SUBORDINATE OFFICERS](index=21&type=section&id=5.3%20SUBORDINATE%20OFFICERS) This section allows for the appointment of additional subordinate officers and agents by the Board or CEO/President - The Board, or the CEO/President, may appoint other officers and agents as needed, with duties and authority determined by bylaws or the Board[90](index=90&type=chunk) [5.4 REMOVAL AND RESIGNATION OF OFFICERS](index=21&type=section&id=5.4%20REMOVAL%20AND%20RESIGNATION%20OF%20OFFICERS) This section outlines the procedures for the removal and resignation of corporate officers - Any officer may be removed, **with or without cause**, by the Board or by an officer empowered by the Board (except for Board-chosen officers)[91](index=91&type=chunk) - Officers may resign at any time by written notice, effective upon receipt or a specified later date, without prejudice to the Corporation's contractual rights[92](index=92&type=chunk) [5.5 VACANCIES IN OFFICES](index=22&type=section&id=5.5%20VACANCIES%20IN%20OFFICES) This section specifies how vacancies in corporate offices are to be filled - Any vacancy in a corporate office shall be filled by the Board or as provided in Section 5.2[93](index=93&type=chunk) [5.6 REPRESENTATION OF SHARES OF OTHER CORPORATIONS](index=22&type=section&id=5.6%20REPRESENTATION%20OF%20SHARES%20OF%20OTHER%20CORPORATIONS) This section grants specific officers the authority to represent the Corporation's interests in other entities - The chairperson, CEO, president, any vice president, treasurer, secretary, or assistant secretary (or other authorized person) may **vote and exercise rights for shares/securities of other corporations** held by Ardelyx, Inc[94](index=94&type=chunk) [5.7 AUTHORITY AND DUTIES OF OFFICERS](index=22&type=section&id=5.7%20AUTHORITY%20AND%20DUTIES%20OF%20OFFICERS) This section broadly defines the authority and duties of the Corporation's officers - Officers shall have authority and perform duties as provided in the bylaws or designated by the Board, and as generally pertain to their respective offices, subject to Board control[95](index=95&type=chunk) [5.8 COMPENSATION](index=22&type=section&id=5.8%20COMPENSATION) This section addresses the compensation of corporate officers - The compensation of officers is **fixed by or at the direction of the Board**[96](index=96&type=chunk) - An officer may receive compensation even if they are also a director[96](index=96&type=chunk) [ARTICLE VI - RECORDS AND REPORTS](index=22&type=section&id=ARTICLE%20VI%20-%20RECORDS%20AND%20REPORTS) This article mandates the maintenance of corporate records, including the stock ledger, and permits electronic record-keeping [6.1 RECORDS AND REPORTS](index=22&type=section&id=6.1%20RECORDS%20AND%20REPORTS) This section mandates the maintenance of corporate records, including the stock ledger, and permits electronic record-keeping - The Corporation must administer a **stock ledger** recording stockholders, addresses, share numbers, and stock issuances/transfers[98](index=98&type=chunk) - Records, including the stock ledger, books of account, and minute books, may be kept electronically, provided they can be converted to legible paper form within a reasonable time[98](index=98&type=chunk) [ARTICLE VII - GENERAL MATTERS](index=22&type=section&id=ARTICLE%20VII%20-%20GENERAL%20MATTERS) This article covers various corporate governance aspects, including contracts, stock issuance, dividends, and fiscal year [7.1 EXECUTION OF CORPORATE CONTRACTS AND INSTRUMENTS](index=22&type=section&id=7.1%20EXECUTION%20OF%20CORPORATE%20CONTRACTS%20AND%20INSTRUMENTS) This section outlines the authority required for officers or agents to execute contracts and instruments on behalf of the Corporation - The Board may authorize any officer or agent to enter into contracts or execute instruments on behalf of the Corporation[100](index=100&type=chunk) - Without such authorization or Board ratification, **no officer, agent, or employee can bind the Corporation** by contract or pledge its credit[100](index=100&type=chunk)[101](index=101&type=chunk) [7.2 STOCK CERTIFICATES; PARTLY PAID SHARES](index=23&type=section&id=7.2%20STOCK%20CERTIFICATES%3B%20PARTLY%20PAID%20SHARES) This section covers the issuance of stock, including certificated and uncertificated shares, and provisions for partly paid shares - Shares may be represented by certificates or be uncertificated, with certificates requiring signatures of **two authorized officers**[102](index=102&type=chunk) - The Corporation may issue partly paid shares, with the amount paid stated on certificates or records, and dividends declared proportionally[103](index=103&type=chunk) [7.3 SPECIAL DESIGNATION ON CERTIFICATES](index=23&type=section&id=7.3%20SPECIAL%20DESIGNATION%20ON%20CERTIFICATES) This section requires disclosure of stock class/series rights on certificates or through notice for uncertificated shares - If multiple classes or series of stock exist, their powers, designations, preferences, and restrictions must be **fully set forth or summarized on certificates** (or in a notice for uncertificated shares)[104](index=104&type=chunk) [7.4 LOST CERTIFICATES](index=23&type=section&id=7.4%20LOST%20CERTIFICATES) This section outlines the procedure for replacing lost, stolen, or destroyed stock certificates - New certificates or uncertificated shares may be issued to replace lost, stolen, or destroyed ones, typically requiring an **indemnification bond** from the owner[105](index=105&type=chunk) [7.5 UNCERTIFICATED SHARES](index=24&type=section&id=7.5%20UNCERTIFICATED%20SHARES) This section permits the Corporation to use an electronic system for issuing, recording, and transferring shares - The Corporation may adopt a system for issuance, recordation, and transfer of shares by **electronic or other means** not involving physical certificates, if permitted by law[106](index=106&type=chunk) [7.6 CONSTRUCTION; DEFINITIONS](index=24&type=section&id=7.6%20CONSTRUCTION%3B%20DEFINITIONS) This section specifies that the DGCL's general provisions and definitions govern the construction of these bylaws - The general provisions, rules of construction, and definitions in the DGCL govern the interpretation of these bylaws, unless the context requires otherwise[107](index=107&type=chunk) [7.7 DIVIDENDS](index=24&type=section&id=7.7%20DIVIDENDS) This section grants the Board authority to declare and pay dividends and establish reserves - The Board may declare and pay dividends on capital stock in cash, property, or shares, subject to DGCL and certificate of incorporation restrictions[108](index=108&type=chunk) - The Board may set apart and abolish reserves from funds available for dividends for proper purposes, such as equalizing dividends or meeting contingencies[109](index=109&type=chunk) [7.8 FISCAL YEAR](index=24&type=section&id=7.8%20FISCAL%20YEAR) This section states that the Board determines and may change the Corporation's fiscal year - The fiscal year of the Corporation is fixed and may be **changed by resolution of the Board**[110](index=110&type=chunk) [7.9 SEAL](index=24&type=section&id=7.9%20SEAL) This section allows the Corporation to adopt and alter a corporate seal - The Corporation may adopt and alter a corporate seal, which can be impressed, affixed, or reproduced[111](index=111&type=chunk) [7.10 TRANSFER OF STOCK](index=24&type=section&id=7.10%20TRANSFER%20OF%20STOCK) This section outlines the procedures for transferring shares of the Corporation's stock - Shares are transferable on the Corporation's books only by the record holder or authorized attorney, upon surrender of certificates (or instructions for uncertificated shares) and necessary evidence[112](index=112&type=chunk) - No stock transfer is valid against the Corporation until entered in its stock records[112](index=112&type=chunk) [7.11 STOCK TRANSFER AGREEMENTS](index=24&type=section&id=7.11%20STOCK%20TRANSFER%20AGREEMENTS) This section grants the Corporation the power to enter into agreements restricting stock transfers - The Corporation has the power to enter into agreements with stockholders to **restrict the transfer of shares** in any manner not prohibited by the DGCL[113](index=113&type=chunk)[114](index=114&type=chunk) [7.12 REGISTERED STOCKHOLDERS](index=25&type=section&id=7.12%20REGISTERED%20STOCKHOLDERS) This section clarifies the Corporation's right to recognize only registered stockholders for dividends and voting - The Corporation is entitled to recognize the **exclusive right of registered owners** to receive dividends and vote[115](index=115&type=chunk) - The Corporation is not bound to recognize equitable or other claims to shares from other persons, except as provided by Delaware law[115](index=115&type=chunk) [7.13 WAIVER OF NOTICE](index=25&type=section&id=7.13%20WAIVER%20OF%20NOTICE) This section defines how notice requirements can be waived for meetings - A written waiver or waiver by electronic transmission, signed by the person entitled to notice, is equivalent to notice[116](index=116&type=chunk) - Attendance at a meeting constitutes a waiver of notice, unless the person attends solely to object to the meeting's legality[116](index=116&type=chunk) [ARTICLE VIII - DELIVERY OF NOTICE; NOTICE BY ELECTRONIC TRANSMISSION](index=25&type=section&id=ARTICLE%20VIII%20-%20DELIVERY%20OF%20NOTICE%3B%20NOTICE%20BY%20ELECTRONIC%20TRANSMISSION) This article specifies the methods and effectiveness of delivering notices to stockholders, including electronic transmission [8.1 DELIVERY OF NOTICE; NOTICE BY ELECTRONIC TRANSMISSION](index=25&type=section&id=8.1%20DELIVERY%20OF%20NOTICE%3B%20NOTICE%20BY%20ELECTRONIC%20TRANSMISSION) This section details the methods and effectiveness of delivering notices to stockholders, including provisions for electronic transmission - Notices to stockholders may be given in writing to mailing addresses or by **electronic transmission to electronic mail addresses**[118](index=118&type=chunk) - Electronic mail notices must include a **prominent legend** indicating it's an important notice[118](index=118&type=chunk) - Notices given by electronic transmission are effective if consented to by the stockholder, though electronic mail can be used without prior consent[119](index=119&type=chunk) [ARTICLE IX - INDEMNIFICATION](index=26&type=section&id=ARTICLE%20IX%20-%20INDEMNIFICATION) This article mandates and permits indemnification and expense advancement for directors, officers, employees, and agents [9.1 INDEMNIFICATION OF DIRECTORS AND OFFICERS](index=26&type=section&id=9.1%20INDEMNIFICATION%20OF%20DIRECTORS%20AND%20OFFICERS) This section mandates the indemnification of directors and officers to the fullest extent permitted by Delaware law - The Corporation shall indemnify directors and officers against all liability and loss (including attorneys' fees, judgments, fines, and settlement amounts) incurred in connection with any proceeding by reason of their service[123](index=123&type=chunk) - Indemnification for proceedings initiated by the person is only required if **authorized by the Board**[123](index=123&type=chunk) [9.2 INDEMNIFICATION OF OTHERS](index=26&type=section&id=9.2%20INDEMNIFICATION%20OF%20OTHERS) This section grants the Corporation the power to indemnify employees and agents - The Corporation has the power to indemnify employees and agents against liability and loss incurred in connection with proceedings by reason of their service, to the fullest extent permitted by law[124](index=124&type=chunk) [9.3 PREPAYMENT OF EXPENSES](index=26&type=section&id=9.3%20PREPAYMENT%20OF%20EXPENSES) This section requires the prepayment of expenses for covered persons and permits it for employees/agents, subject to an undertaking to repay - The Corporation shall pay expenses (including attorneys' fees) incurred by covered persons in defending proceedings **in advance of final disposition**[125](index=125&type=chunk) - Such advance payments require an **undertaking by the person to repay** if ultimately determined not entitled to indemnification[126](index=126&type=chunk) [9.4 DETERMINATION; CLAIM](index=27&type=section&id=9.4%20DETERMINATION%3B%20CLAIM) This section outlines the process for making and resolving claims for indemnification or expense advancement - If an indemnification or expense advancement claim is not paid within **60 days**, the claimant may file suit to recover the unpaid amount[127](index=127&type=chunk) - In such a suit, the Corporation bears the burden of proving the claimant was not entitled to the requested indemnification or payment[127](index=127&type=chunk) [9.5 NON-EXCLUSIVITY OF RIGHTS](index=27&type=section&id=9.5%20NON-EXCLUSIVITY%20OF%20RIGHTS) This section clarifies that the indemnification rights provided are not exclusive of other available rights - The indemnification rights conferred by this Article are **not exclusive** of any other rights a person may have under statute, certificate of incorporation, bylaws, agreement, or stockholder/director vote[128](index=128&type=chunk) [9.6 INSURANCE](index=27&type=section&id=9.6%20INSURANCE) This section permits the Corporation to purchase and maintain insurance for directors, officers, employees, and agents - The Corporation may purchase and maintain insurance on behalf of any director, officer, employee, or agent against liabilities, whether or not the Corporation would have the power to indemnify them under DGCL[129](index=129&type=chunk) [9.7 OTHER INDEMNIFICATION](index=27&type=section&id=9.7%20OTHER%20INDEMNIFICATION) This section specifies that the Corporation's indemnification obligations may be reduced by amounts collected from other entities - The Corporation's obligation to indemnify or advance expenses to a person serving at its request for another entity shall be **reduced by any amount such person collects** from that other entity[130](index=130&type=chunk) [9.8 CONTINUATION OF INDEMNIFICATION](index=27&type=section&id=9.8%20CONTINUATION%20OF%20INDEMNIFICATION) This section ensures that indemnification rights continue even after a person ceases to be a director or officer - Indemnification and prepayment rights **continue after a person ceases to be a director or officer** and inure to the benefit of their estate and heirs[131](index=131&type=chunk) [9.9 AMENDMENT OR REPEAL](index=27&type=section&id=9.9%20AMENDMENT%20OR%20REPEAL) This section establishes that the indemnification provisions constitute a contract and protects existing rights from adverse amendment or repeal - The provisions of Article IX constitute a **legally binding contract** between the Corporation and its current/former directors and officers, with rights fully vested upon adoption of bylaws or commencement of service[132](index=132&type=chunk)[133](index=133&type=chunk) - Any repeal or modification of Article IX shall **not adversely affect existing indemnification rights** for acts or omissions occurring prior to such change[133](index=133&type=chunk) - References to 'officer' in this Article are limited to specific roles appointed by the Board or delegated authority, excluding those merely holding a 'Vice President' title without formal appointment[134](index=134&type=chunk) [ARTICLE X - AMENDMENTS](index=28&type=section&id=ARTICLE%20X%20-%20AMENDMENTS) This article outlines the process and voting requirements for amending or repealing the Corporation's bylaws [10.1 AMENDMENTS](index=28&type=section&id=10.1%20AMENDMENTS) This section outlines the process and voting requirements for amending or repealing the Corporation's bylaws - The Board is empowered to **adopt, amend, or repeal the bylaws**[136](index=136&type=chunk) - Stockholder action to amend or repeal bylaws requires the affirmative vote of at least **66-2/3%** of the voting power of all outstanding voting stock[136](index=136&type=chunk) [ARTICLE XI – FORUM SELECTION](index=28&type=section&id=ARTICLE%20XI%20%E2%80%93%20FORUM%20SELECTION) This article designates specific courts in Delaware as the exclusive forum for certain corporate litigation and federal courts for Securities Act claims [11.1 FORUM SELECTION](index=28&type=section&id=11.1%20FORUM%20SELECTION) This section designates specific courts in Delaware as the exclusive forum for certain corporate litigation and federal courts for Securities Act claims - The **Court of Chancery in Delaware** (or other Delaware state/federal courts if jurisdiction is lacking) is the sole and exclusive forum for derivative actions, fiduciary duty claims, DGCL claims, and internal affairs doctrine claims[138](index=138&type=chunk) - Federal district courts of the United States are the **exclusive forum for claims arising under the Securities Act of 1933**[139](index=139&type=chunk) - Any person acquiring shares is deemed to have notice of and consented to these forum selection provisions[140](index=140&type=chunk) [ARTICLE XII - DEFINITIONS](index=29&type=section&id=ARTICLE%20XII%20-%20DEFINITIONS) This article provides definitions for key terms used throughout the bylaws, particularly related to electronic communications and the term 'person' [12.1 DEFINITIONS](index=29&type=section&id=12.1%20DEFINITIONS) This section provides definitions for key terms used throughout the bylaws, particularly related to electronic communications and the term 'person' - An '**electronic transmission**' is defined as any non-paper communication creating a retrievable record reproducible in paper form[143](index=143&type=chunk) - An '**electronic mail**' is an electronic transmission directed to a unique electronic mail address, including attachments and hyperlinked information[144](index=144&type=chunk) - The term '**person**' is broadly defined to include various legal entities and organizations[146](index=146&type=chunk)
Ardelyx Announces Changes to the Executive Leadership Team
Globenewswire· 2025-08-04 20:08
Core Insights - Ardelyx, Inc. announced significant changes to its Executive Leadership Team, including the appointment of Edward Conner, M.D. as Chief Medical Officer and John Bishop, Ph.D. as Chief Technical Operations Officer [1][2][3] - Justin Renz, the current Chief Financial and Operations Officer, is expected to transition out of the company, with a commitment to assist during the transition period [4][5] Leadership Changes - Edward Conner, M.D. brings over 20 years of experience in advancing innovative therapies through clinical development and regulatory approval across various therapeutic areas [2] - John Bishop, Ph.D. has over 30 years of experience in leading technical operations, quality assurance, and regulatory activities, reflecting the importance of technical operations in the company's future success [3] - The company has also welcomed other leaders, including Mike Kelliher as Chief Business Officer and Laura Williams as Chief Patient Officer, to enhance its leadership capabilities [4] Company Vision and Future - The leadership changes are part of Ardelyx's strategy to position itself for the next phase of growth, focusing on building a robust pipeline and achieving its vision of creating a healthier tomorrow for patients [4] - Ardelyx has two commercial products approved in the U.S., IBSRELA and XPHOZAH, and has established agreements for the development and commercialization of tenapanor in various international markets [6]
Ardelyx Reports Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-08-04 20:01
Core Insights - Ardelyx, Inc. reported strong commercial performance in Q2 2025, achieving total revenue of $97.7 million, which represents a 33% increase year-over-year and a 32% increase quarter-over-quarter [1][3][8] - The company raised its 2025 revenue expectations for IBSRELA to between $250 million and $260 million, reflecting confidence in the product's market performance [1][4][3] Financial Performance - IBSRELA generated net sales revenue of $65.0 million in Q2 2025, marking an 84% increase year-over-year and a 46% increase quarter-over-quarter [4][14] - XPHOZAH recorded net sales revenue of $25.0 million in Q2 2025, showing a 7% increase compared to Q1 2025, and a 27% increase when excluding a one-time returns reserve release [5][14] - Total cash, cash equivalents, and short-term investments as of June 30, 2025, were $238.5 million, down from $250.1 million at the end of 2024 [7][29] Expenses and Losses - Research and development expenses for Q2 2025 were $15.7 million, up from $12.8 million in Q2 2024 [9] - Selling, general, and administrative expenses increased to $84.0 million in Q2 2025 from $64.7 million in Q2 2024, primarily due to increased commercialization efforts [9] - The net loss for Q2 2025 was $19.1 million, or $(0.08) per share, compared to a net loss of $16.5 million, or $(0.07) per share, in Q2 2024 [10][29] Corporate Developments - In July 2025, the company amended its loan agreement, allowing it to draw an additional $100 million of debt, consisting of two tranches of $50 million [6] - The company appointed Mike Kelliher as Chief Business Officer and James P. Brady as Chief Human Resources Officer [6] - Ardelyx presented research findings at the 2025 Digestive Disease Week Conference, highlighting the correlation between the severity of IBS-C and financial hardship [6]
Earnings Preview: Ardelyx (ARDX) Q2 Earnings Expected to Decline
ZACKS· 2025-07-28 15:06
Company Overview - Ardelyx (ARDX) is expected to report a year-over-year decline in earnings despite higher revenues for the quarter ended June 2025, with a consensus outlook indicating a quarterly loss of $0.13 per share, representing an 85.7% decrease from the previous year [1][3] - Revenues are projected to be $84.64 million, reflecting a 15.6% increase compared to the same quarter last year [3] Earnings Expectations - The earnings report is anticipated to be released on August 4, and the stock may experience upward movement if the reported numbers exceed expectations; conversely, a miss could lead to a decline in stock price [2] - The consensus EPS estimate has been revised down by 6.25% over the last 30 days, indicating a reassessment by analysts regarding the company's earnings prospects [4] Earnings Surprise Prediction - The Most Accurate Estimate for Ardelyx is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -6.18%, which suggests a bearish outlook from analysts [12] - The company currently holds a Zacks Rank of 4, making it challenging to predict a beat on the consensus EPS estimate [12] Historical Performance - In the last reported quarter, Ardelyx was expected to post a loss of $0.10 per share but actually reported a loss of $0.17, resulting in a surprise of -70.00% [13] - Over the past four quarters, Ardelyx has beaten consensus EPS estimates two times [14] Industry Comparison - In the Zacks Medical - Drugs industry, United Therapeutics (UTHR) is expected to report earnings of $6.8 per share for the same quarter, indicating a year-over-year increase of 16.2% [18] - United Therapeutics' revenue is projected to be $795.75 million, up 11.3% from the previous year, with a revised consensus EPS estimate down by 2.4% over the last 30 days but an Earnings ESP of +7.09% [19][20]
Ardelyx to Report Second Quarter 2025 Financial Results on August 4, 2025
GlobeNewswire News Room· 2025-07-21 12:00
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has be ...
Ardelyx (ARDX) Earnings Call Presentation
2025-06-19 15:59
Financial Performance & Expectations - Ardelyx reported $44.4 million in net sales revenue for IBSRELA and $23.4 million for XPHOZAH in Q1 2025[5] - The company finished Q1 2025 with $214.0 million in cash and investments[5] - Ardelyx anticipates U S IBSRELA net product sales revenue to be between $240 million and $250 million for the full year 2025[9, 64] - IBSRELA is projected to achieve approximately 10% market share at its peak, generating over $1 billion in net product sales revenue before its patent expires[9, 36] - XPHOZAH is expected to generate $750 million in annual net product sales revenue before its patent expires[41, 62] - Ardelyx expects aggregate peak revenue for both products to be greater than $175 billion annually before patent expiration[65, 76] Market Overview & Clinical Data - The U S IBS-C indicated net product sales reached $40 billion in 2024, representing a 16% increase compared to 2023[14] - TRxs for IBS-C indicated products have grown 21% from 2020 to 2024[15] - Approximately 70% of patients on phosphate binders are unable to consistently achieve and maintain target phosphorus levels over a 6-month period[39, 44, 62] - In a long-term Phase 3 trial, 365% of IBSRELA-treated patients were overall responders, compared to placebo[26, 27] - 96% of surveyed nephrologists rate XPHOZAH as a moderate or substantial advancement[57]
Ardelyx (ARDX) 2025 Conference Transcript
2025-06-04 13:10
Summary of Ardelyx (ARDX) Conference Call Company Overview - Ardelyx has experienced significant fluctuations over the past few years, particularly since 2021 when it launched Ibsrela after overcoming a Complete Response Letter (CRL) from the FDA regarding Exposa [3][4] - The company currently markets two products: Ibsrela for IBS-C and Exposa for dialysis patients with hyperphosphatemia [4][5] Financial Guidance and Performance - Ardelyx reaffirmed its revenue guidance for Ibsrela at $240 million to $250 million for the current year [5][12] - The company noted that the IBS-C market has been growing at double digits for the past three to four years, with 50,000 new patients starting therapy for GCC agonists each month [8][9] - The company aims for Ibsrela to reach peak sales of $1 billion, with the potential to achieve this sooner than the previously projected timeline of 2033 [18][19] Market Dynamics - The first quarter typically sees a contraction in the IBS-C market due to insurance policy resets, which affects patient access and spending [7][8] - Despite the contraction, Ibsrela continues to gain traction, with positive feedback from physicians regarding its efficacy compared to GCC agonists [13][14] - The company is exploring additional indications for Ibsrela, such as Chronic Idiopathic Constipation (CIC), which has a larger patient population compared to IBS-C [24][28] Exposa Performance and Strategy - Exposa generated $25 million in revenue in Q1, with the company focusing on maintaining patient access rather than reimbursement issues [29][30] - The decision not to participate in the TDAPA process was made to ensure non-Medicare patients have access to Exposa, despite losing 60% of the total addressable market (TAM) due to changes in Medicare coverage [30][37] - The company is optimistic about Exposa's growth potential, targeting peak sales of $750 million by penetrating 30% of the 220,000 patients in the market [34][58] Regulatory and Legal Considerations - Ardelyx is currently appealing a CMS decision that classifies Exposa as a renal dialysis service, which could restore access for a significant portion of patients [53][57] - A favorable outcome from the appeal could increase the patient base by 60%, significantly impacting revenue potential [59][60] Business Development and Future Outlook - Ardelyx is actively seeking business development opportunities to expand its product portfolio, focusing on both GI and renal markets [63] - The company aims to build a sustainable enterprise by identifying and acquiring products that align with its strategic goals [64] Key Takeaways - Ardelyx is positioned for growth with its two commercial products, Ibsrela and Exposa, despite facing market challenges and regulatory hurdles - The company is optimistic about achieving its financial targets and expanding its market presence through strategic initiatives and potential new indications for its products
Ardelyx Appoints Mike Kelliher Chief Business Officer and James P. Brady Chief Human Resources Officer
Globenewswire· 2025-06-02 20:05
Core Insights - Ardelyx, Inc. has announced the promotion of Mike Kelliher to Chief Business Officer and the appointment of James P. Brady as Chief Human Resources Officer, indicating a strategic move to enhance leadership for long-term growth and value creation [1][4] Leadership Changes - Mike Kelliher, previously Executive Vice President of Corporate Development and Strategy, will now oversee lifecycle and portfolio management in addition to his existing responsibilities [2] - James P. Brady brings extensive experience in human resources and organizational development, tasked with building and retaining a high-performing team to support Ardelyx's growth [3][5] Executive Backgrounds - Mike Kelliher has a strong background in M&A and business development, having previously served at Horizon Therapeutics and holds a Bachelor of Commerce from University College Cork [4] - James P. Brady has held significant HR roles at companies like Spero Therapeutics and uniQure, and has a Bachelor of Arts from Marietta College and a Master of Theological Studies from Harvard University [5] Company Overview - Ardelyx focuses on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs, with two commercial products approved in the U.S. [6]