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Wave Life Sciences .(WVE) - 2023 Q2 - Quarterly Report
2023-08-03 11:56
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 ☐ 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: 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore (State or other jurisd ...
Wave Life Sciences .(WVE) - 2023 Q1 - Earnings Call Transcript
2023-05-03 17:48
Wave Life Sciences Ltd. (NASDAQ:WVE) Q1 2023 Earnings Conference Call May 3, 2023 8:30 AM ET Company Participants Kate Rausch - VP, IR and Corporate Affairs Paul Bolno - President and CEO Anne-Marie Li-Kwai-Cheung - Chief Development Officer Kyle Moran - CFO Conference Call Participants Mike Linden - Mizuho Joon Lee - Truist Securities Mani Foroohar - SVB Securities Lisa Walter - RBC Operator Good morning, and welcome to the Wave Life Sciences First Quarter 2023 Earnings Call. [Operator Instructions] As a r ...
Wave Life Sciences .(WVE) - 2023 Q1 - Quarterly Report
2023-05-03 11:55
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 ☐ 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: 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore (State or other juris ...
Wave Life Sciences .(WVE) - 2022 Q4 - Annual Report
2023-03-23 11:31
Financial Performance - The company reported a net loss of $161.8 million for the fiscal year ended December 31, 2022, compared to a net loss of $122.2 million for 2021, with an accumulated deficit of $967.3 million as of December 31, 2022[313]. - The company has not generated any product revenue to date and does not expect to do so for the foreseeable future, anticipating continued significant operating losses due to R&D and regulatory costs[314]. - The company expects to require substantial additional funding for ongoing R&D and commercialization efforts, with future capital requirements being uncertain[315]. - The company has raised approximately $1,021.2 million in net proceeds through securities sales and collaborations as of December 31, 2022, with an additional $170.0 million received post-year-end[318]. - The company has $430.0 million in securities available for issuance under its 2022 Form S-3 registration, including approximately $132.0 million in ordinary shares[319]. Research and Development - The company has a diverse pipeline of PN-modified, stereopure oligonucleotides targeting muscle, hepatic, and CNS diseases, but faces significant risks in developing these novel therapies[331]. - The company has invested significantly in the development of oligonucleotides and manufacturing capabilities, but currently has no products on the market[337]. - The company’s pipeline includes programs targeting muscle diseases (DMD), hepatic diseases (AATD), and CNS diseases (HD, ALS, and FTD) using various modalities[336][346]. - The complexity of oligonucleotide manufacturing poses risks such as delays, contamination, and quality control issues that could adversely affect clinical trials[344][347]. - The company may face significant delays in clinical trials due to various factors, including the ability to recruit patients and manage the impact of the COVID-19 pandemic[340]. Regulatory Environment - The FDA has approved 15 oligonucleotides for marketing and commercialization, indicating a limited experience with this drug class which may complicate regulatory approval processes[333]. - The time required for FDA and other regulatory approvals is unpredictable and can take many years, affecting the commercialization timeline[360]. - Ongoing regulatory oversight post-approval is necessary, and failure to comply could result in penalties or withdrawal of approvals[365]. - The FDA has significant post-market authority, including the ability to require labeling changes and additional studies based on new safety information[366]. - Regulatory compliance failures could lead to enforcement actions, harming the company's reputation and ability to market its products[381]. Market and Competition - Market acceptance of the company's product candidates may be hindered despite receiving regulatory approval, as key market participants may not adopt new therapeutic technologies[369]. - The company faces intense competition from existing drugs and new entrants in the pharmaceutical market, which may affect its ability to commercialize its products successfully[372]. - Competitors may have advantages such as greater financial resources, extensive experience, and established products, which could impact the company's competitive position[374]. - The company may face unfavorable pricing regulations and reimbursement practices that could negatively impact its business and revenue potential[382]. Collaborations and Partnerships - The company commenced a collaboration with GSK in January 2023 to research, develop, and commercialize oligonucleotide therapeutics, including WVE-006, a preclinical RNA editing candidate for AATD[406]. - The collaboration with Takeda, initiated in April 2018, allows Takeda to globally co-develop and commercialize programs targeting HD, ALS, FTD, and SCA3, with the company retaining co-commercialization rights in the United States[406]. - The company does not currently have any sales and marketing or distribution capabilities, relying on collaborations to build these capabilities[410]. - Collaborations may not lead to efficient development or commercialization of product candidates, and business combinations among collaborators could delay or terminate programs[409]. Intellectual Property - The company may face challenges in protecting its intellectual property rights globally, particularly in jurisdictions with weaker enforcement mechanisms[453]. - Patent protection for biopharmaceuticals varies by jurisdiction, and the company may face challenges in obtaining patents for certain product candidates[443]. - The evolving landscape of oligonucleotide intellectual property may hinder the company's ability to commercialize its product candidates[460]. - The company may need to obtain licenses from third parties for certain patents, which could be costly or unavailable on reasonable terms[462]. Operational Risks - The company relies on third parties for raw materials and clinical trials, which may be disrupted, affecting R&D activities and causing potential pricing increases[329]. - The company has experienced delays in clinical trials due to the COVID-19 pandemic, impacting patient enrollment and site initiation[327]. - The company is highly dependent on attracting and retaining qualified personnel, with challenges in recruitment potentially impacting development timelines and business execution[425]. - Increased competition for personnel from other biotechnology and pharmaceutical companies may hinder the company's ability to attract necessary talent[425]. Financial and Tax Considerations - The company is subject to various tax regulations, and future changes in U.S. or foreign tax laws may adversely affect its business and financial condition[437]. - The company may face increased tax liabilities due to challenges from tax authorities regarding income and deductions among its subsidiaries[485]. - The company has general authority to allot and issue new ordinary shares, which could dilute existing shareholders' interests[479]. - The market price of the company's ordinary shares is expected to be highly volatile, influenced by factors beyond its control, which may lead to significant investment losses for shareholders[492].
Wave Life Sciences .(WVE) - 2022 Q2 - Quarterly Report
2022-08-11 11:51
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 ☐ 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: 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore (State or other jurisd ...
Wave Life Sciences .(WVE) - 2022 Q1 - Quarterly Report
2022-05-12 11:41
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore (State or other jurisdiction of incorporation or organization) 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, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For th ...
Wave Life Sciences .(WVE) - 2021 Q4 - Annual Report
2022-03-03 12:46
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore Not applicable (State or other jurisdiction ...
Wave Life Sciences .(WVE) - 2021 Q3 - Earnings Call Presentation
2021-11-10 20:05
WAVE | --- | --- | --- | --- | --- | --- | --- | |----------------------------|--------------------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | Third Quarter 2021 | Wave Life Sciences | | | | | | | Earnings November 10, 2021 | | | | | | | Forward-looking statements 2 This document contains forward-looking statements. All statements other than statements of historical facts contained in this document, including statements regarding possible or assumed future results of operatio ...
Wave Life Sciences .(WVE) - 2021 Q3 - Quarterly Report
2021-11-10 12:43
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 ☐ 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: 001-37627 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore (State or other j ...
Wave Life Sciences .(WVE) - 2021 Q2 - Earnings Call Transcript
2021-08-08 07:18
Wave Life Sciences Ltd. (NASDAQ:WVE) Q2 2021 Earnings Conference Call August 5, 2021 8:30 AM ET Company Participants Kate Rausch - Head, Investor Relations Paul Bolno - President & Chief Executive Officer Mike Panzara - Chief Medical Officer Head, Therapeutics Discovery & Development Paloma Giangrande - Vice President, Platform and Discovery Sciences & Biology Kyle Moran - Chief Financial Officer Conference Call Participants Mehdi Goudarzi - Truist Salim Syed - Mizuho Alex Thompson - Stifel Operator Good m ...