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Xenon(XENE) - 2023 Q2 - Quarterly Report
2023-08-09 20:38
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, 2023 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: 001-36687 XENON PHARMACEUTICALS INC. (Exact name of Registrant as Specified in its Charter) (State or other ju ...
Xenon(XENE) - 2023 Q1 - Earnings Call Transcript
2023-05-13 23:13
Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q1 2023 Results Conference Call May 9, 2023 4:30 PM ET Company Participants Sherry Aulin - CFO Ian Mortimer - President and CEO Dr. Chris Kenney - CMO Dr. Chris Von Seggern - Chief Commercial Officer Conference Call Participants Paul Matteis - Stifel Brian Abrahams - RBC Capital Markets Tessa Romero - J.P. Morgan Andrew Tsai - Jefferies Joseph Thome - TD Cowen Rudy Li - SVB Danielle Brill - Raymond James Laura Chico - Wedbush Securities Elaine Kim - Cantor Fitzgerald ...
Xenon(XENE) - 2023 Q1 - Quarterly Report
2023-05-09 20:36
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 March 31, 2023 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: 001-36687 XENON PHARMACEUTICALS INC. (Exact name of Registrant as Specified in its Charter) Canada 98-0661854 ...
Xenon(XENE) - 2022 Q4 - Earnings Call Transcript
2023-03-02 03:10
Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q4 2022 Earnings Conference Call March 1, 2023 4:30 PM ET Company Participants Sherry Aulin - CFO Ian Mortimer - President and CEO Chris Kenney - CMO Chris Von Seggern - CCO Conference Call Participants Brian Abrahams - RBC Capital Markets Tessa Romero - JPMorgan Paul Choi - Goldman Sachs Joseph Thome - TD Cowen Andrew Tsai - Jefferies Rudy Li - SVB Securities Laura Chico - Wedbush Rohit Bhasin - Needham & Company Operator Ladies and gentlemen, thank you for standing ...
Xenon(XENE) - 2022 Q4 - Annual Report
2023-03-01 21:39
Financial Performance - The company incurred net losses of $125.4 million, $78.9 million, and $28.8 million for the years ended December 31, 2022, 2021, and 2020, respectively, with an accumulated deficit of $482.7 million as of December 31, 2022[165]. - The company expects to incur significant expenses and increasing operating losses for the foreseeable future due to ongoing research and development activities[166]. - The company anticipates that its existing cash and cash equivalents will enable it to fund operating expenses for at least the next 12 months[171]. - The company may need to raise additional funding, which may not be available on acceptable terms, potentially delaying or terminating product development programs[169]. - The company had Canadian federal net operating loss carryforwards totaling $338.0 million as of December 31, 2022, which will begin to expire in 2026[212]. - The company also had Canadian federal investment tax credit carryforwards of $27.3 million and provincial investment tax credit carryforwards of $8.4 million, which will begin to expire in 2023[212]. Product Development and Commercialization - The company does not generate any revenue from product sales and may never become profitable, as successful commercialization depends on completing development and obtaining regulatory approvals[167]. - The company has no marketed proprietary products and has not completed clinical development beyond Phase 2, complicating its ability to assess future product commercialization[184]. - The company has built a product development pipeline through internal research and acquisitions, with notable candidates like XEN901, now known as NBI-921352, licensed to Neurocrine Biosciences[186]. - The company is heavily investing in the development of its lead product candidate, XEN1101, for the treatment of epilepsy, with no products currently approved for commercial sale[224]. - Successful completion of the XEN1101 Phase 3 program is critical for future business success, with various risks associated with clinical development and regulatory approval[224]. - The company faces challenges in patient enrollment for clinical trials, particularly for ultra-orphan and niche indications, which may delay or prevent clinical trials[239]. - The company must demonstrate that its product candidates are both safe and effective through lengthy and expensive clinical trials before obtaining regulatory approvals[236]. - The company acknowledges that the results of pre-clinical studies may not predict outcomes in later-stage clinical trials, which could lead to unexpected difficulties in obtaining regulatory approval[230]. - The company may incur unexpected costs or delays in the development and commercialization of product candidates due to regulatory approval requirements[244]. Regulatory and Compliance Risks - The company is subject to extensive laws and regulations in the healthcare industry, which could lead to significant compliance costs and potential liabilities[192]. - The company may face significant civil, criminal, and administrative penalties if found in violation of healthcare laws and regulations, which could adversely affect its business[220]. - The company is subject to various healthcare laws, including the federal Anti-Kickback Statute and the federal False Claims Act, which could expose it to legal risks[219]. - The regulatory approval process is lengthy and unpredictable, with potential for significant delays in obtaining marketing approval[257]. - Compliance with changing regulatory requirements can result in increased costs and delays in clinical development plans[262]. - The company may face challenges in demonstrating the safety and efficacy of product candidates to regulatory authorities, impacting approval chances[261]. Market and Competitive Landscape - The company faces substantial competition in the biotechnology and pharmaceutical markets, which may impact its ability to successfully develop and commercialize products[179]. - The company may allocate limited resources to specific product candidates, potentially missing out on more profitable opportunities[173]. - The company’s product candidates targeting rare and ultra-rare disorders may face difficulties in identifying and accessing the limited patient populations, impacting profitability[290]. - Coverage and reimbursement from government programs and private insurers are uncertain, which could adversely affect the commercialization of approved products[292]. - The company must navigate varying price control mechanisms in international markets, which may restrict pricing and reimbursement levels compared to the U.S.[296]. Operational and Growth Challenges - The company may encounter difficulties in managing growth, which could result in operational errors and loss of business opportunities[195]. - The company is highly dependent on its executive officers, and the loss of key personnel could materially delay the development of product candidates[189]. - The company plans to hire additional personnel to expand clinical development activities and commercial capabilities, facing competition for skilled individuals in the pharmaceutical and biotechnology sectors[190]. - The company faces risks associated with evolving global laws and regulations related to privacy and data protection, which may increase compliance costs[196]. - The COVID-19 pandemic has the potential to disrupt the company's supply chain and clinical trials, affecting its business operations[204]. Intellectual Property Risks - The company faces challenges in maintaining adequate patent protection, which is crucial for commercial success[331]. - Intellectual property rights may not provide competitive advantages due to limitations and potential legal challenges[335]. - The company may face claims of patent infringement from third parties, leading to costly litigation and potential damage awards[348]. - Future intellectual property litigation could limit research and development activities and commercialization of products[354]. - The company may need to seek licenses from third parties to avoid patent claims, which could be costly and not available on acceptable terms[355]. Collaboration and Dependency Risks - The company is dependent on collaborators, such as Neurocrine Biosciences, for the research, development, and commercialization of product candidates, which introduces significant uncertainty[305]. - The success of the collaboration with Neurocrine Biosciences for NBI-921352 is largely beyond the company's control, impacting potential financial returns[309]. - The company faces risks related to potential termination of collaboration agreements, which could require it to assume responsibilities and costs for ongoing clinical trials[312]. Manufacturing and Supply Chain Risks - The company relies on third parties for the manufacture and supply of active pharmaceutical ingredients and final drug products, increasing the risk of supply issues[317]. - Manufacturing biopharmaceutical products is complex and requires significant expertise and capital investment, with potential delays in clinical trials due to manufacturing issues[318]. - The company does not enter into long-term supply agreements with manufacturers, which may adversely affect the ability to complete product development[320]. - Compliance with cGMP regulations is mandatory, and any failure could lead to delays in regulatory approval for product candidates[321].
Xenon(XENE) - 2022 Q3 - Earnings Call Transcript
2022-11-09 01:50
Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q3 2022 Results Conference Call November 8, 2022 4:30 PM ET Company Participants Sherry Aulin - Chief Financial Officer Ian Mortimer - President and Chief Executive Officer Chris Kenney - Chief Medical Officer Chris Von Seggern - Chief Commercial Officer Conference Call Participants Paul Matteis - Stifel Andrew Tsai - Jefferies Tessa Romero - JP Morgan Brian Abrahams - RBC Capital Markets Madhumita Yennawar - SVB Securities Laura Chico - Wedbush Yatin Suneja - Guggen ...
Xenon(XENE) - 2022 Q3 - Quarterly Report
2022-11-08 21:36
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 September 30, 2022 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: 001-36687 XENON PHARMACEUTICALS INC. (Exact name of Registrant as Specified in its Charter) Canada 98-066 ...
Xenon Pharmaceuticals (XENE) Investor Presentation - Slideshow
2022-08-17 16:19
Corporate Overview A U G U S T 2 0 2 2 NASDAQ: XENE www.xenon-pharma.com Forward Looking Statement/Safe Harbor This slide presentation and the accompanying oral commentary contain forward-looking statements that involve risks, uncertainties and assumptions. If the risks or uncertainties ever materialize or the assumptions prove incorrect, our results may differ materially from those expressed or implied by such forward-looking statements. All statements other than statements of historical fact could be deem ...
Xenon(XENE) - 2022 Q2 - Earnings Call Transcript
2022-08-10 21:01
Xenon Pharmaceuticals Inc. (NASDAQ:XENE) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Sherry Aulin - Chief Financial Officer Ian Mortimer - President and Chief Executive Officer Chris Kenney - Chief Medical Officer Chris Von Seggern - Chief Commercial Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Tessa Romero - JPMorgan Marc Goodman - SVB Andrew Tsai - Jefferies David Hoang - SMBC Lachlan Hanbury - William Blair Operator Good afternoon and welco ...
Xenon(XENE) - 2022 Q2 - Quarterly Report
2022-08-09 20:37
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, 2022 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: 001-36687 XENON PHARMACEUTICALS INC. (Exact name of Registrant as Specified in its Charter) Canada 98-0661854 (State or other jurisd ...