Core Insights - Arvinas, Inc. reported fourth-quarter sales results that were worse than expected, with quarterly losses of $0.63 per share, which was better than the analyst consensus estimate of a loss of $0.87 per share. However, quarterly sales of $59.20 million missed the analyst consensus estimate of $65.28 million [1][2] Group 1: Financial Performance - The company reported a quarterly loss of $0.63 per share, beating the analyst consensus estimate of a loss of $0.87 per share [1] - Quarterly sales were $59.20 million, missing the analyst consensus estimate of $65.28 million [1] Group 2: Future Outlook - The CEO of Arvinas highlighted significant progress in their pipeline for 2024, emphasizing the upcoming results from the VERITAC-2 Phase 3 clinical trial and the first-in-human data for the ARV-102 neuroscience program [2] - The company anticipates sharing additional updates from its pipeline and PROTAC platform in the coming months [2] Group 3: Analyst Ratings and Price Targets - Following the earnings announcement, analysts adjusted their price targets for Arvinas: - Stifel analyst lowered the price target from $63 to $51 while maintaining a Buy rating [4] - BMO Capital reiterated an Outperform rating and cut the price target from $88 to $82 [4] - Oppenheimer maintained an Outperform rating and raised the price target from $40 to $45 [4]

Clinical Development Programs - The company is advancing multiple clinical development programs, including vepdegestrant for ER+/HER2- breast cancer and ARV-393 for non-Hodgkin lymphoma, with ongoing trials expected to yield topline data in 2025[693][701]. - Vepdegestrant has shown near-complete ER degradation in preclinical studies and is currently involved in several clinical trials, including the Phase 3 VERITAC-2 trial, which completed patient enrollment in Q4 2024[697][699]. - ARV-393 has demonstrated potent anti-tumor activity in preclinical models and has received FDA clearance for its IND, with a Phase 1 clinical trial initiated in Q2 2024[702][703]. - The company is conducting two clinical trials for ARV-102, targeting neurodegenerative diseases, with the first-in-human Phase 1 trial initiated in Q1 2024 and the multiple ascending dose portion starting in Q3 2024[704][706]. - Preclinical data for ARV-102 indicates it crosses the blood-brain barrier and degrades LRRK2, with significant findings presented at various conferences, including a ~50% reduction in pathological tau in murine models[705][709]. - The company has a robust pipeline of PROTAC protein degraders targeting "undruggable" proteins across oncology and neuroscience, aiming to address unmet medical needs[692][694]. - The collaboration with Pfizer for vepdegestrant includes co-development and commercialization rights, enhancing the potential for market expansion in breast cancer therapies[696]. - The company plans to present preliminary data from ongoing clinical trials in 2025, including ARV-393 and ARV-102, to showcase advancements in treatment options for patients[702][707]. - The strategic focus on protein degradation therapies is expected to provide distinct advantages over traditional therapies, positioning the company as a leader in innovative treatment modalities[692]. Financial Performance and Revenue - The company has raised approximately $1.7 billion in gross proceeds since inception through asset sales and equity interests, with $913 million received from collaboration partners and licensing arrangements[718]. - The Novartis Transaction includes a one-time upfront payment of $150 million and potential contingent payments of up to $1.01 billion based on development, regulatory, and commercial milestones for luxdegalutamide (ARV-766)[726]. - The Vepdegestrant (ARV-471) Collaboration Agreement with Pfizer includes an upfront payment of $650 million and potential additional payments of up to $1.4 billion based on regulatory and sales milestones[729]. - The Bayer Collaboration Agreement resulted in an upfront payment of $17.5 million and additional payments totaling $12 million, with potential milestone payments of up to $197.5 million for development and $490 million for sales[739]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future, relying instead on collaboration agreements and licensing arrangements for revenue[722]. - Revenue for the year ended December 31, 2024, totaled $263.4 million, a significant increase of $184.9 million compared to $78.5 million in 2023, primarily driven by the Novartis License Agreement and the Novartis Asset Agreement[771]. - Revenue is recognized ratably over the expected performance period under each respective arrangement, with no revenue from sales-based milestone and royalty payments recognized to date[763]. Research and Development Expenses - Total research and development expenses for the year ended December 31, 2024, were $348.2 million, a decrease from $379.7 million in 2023[746]. - Research and development expenses related to vepdegestrant are shared equally with Pfizer since July 22, 2021[747]. - Research and development expenses decreased to $348.2 million in 2024 from $379.7 million in 2023, a reduction of $31.5 million, mainly due to a decrease in external expenses[772]. - Total program-specific external expenses for the year ended December 31, 2024, were $127.2 million, compared to $159.3 million in 2023[746]. Operating Losses and Financial Outlook - The company expects to incur increasing operating losses for at least the next several years due to ongoing and anticipated preclinical and clinical activities[719]. - The company has incurred significant operating losses since inception and expects to continue incurring significant expenses as it advances product development[792]. - The company anticipates substantial additional financing needs due to ongoing clinical trials and product development, with potential revenue generation from product sales not yet realized[795]. - The company expects to finance cash needs through equity offerings, debt financings, and strategic alliances until substantial revenue is generated[795]. Cash and Investments - Cash, cash equivalents, restricted cash, and marketable securities totaled $1.0 billion as of December 31, 2024, down from $1.3 billion in 2023[784]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of approximately $1.0 billion, expected to fund operations into 2027[794]. - Interest income from cash, cash equivalents, and marketable securities totaled $54.9 million in 2024, sensitive to changes in U.S. interest rates[800]. - Net cash used in operating activities decreased by $88.5 million in 2024, primarily due to a reduction in net loss of $168.4 million compared to 2023[785]. - Net cash provided by investing activities decreased by $168.8 million in 2024, primarily due to a net decrease in maturities and sales of marketable securities[787]. - Net cash provided by financing activities decreased by $366.8 million in 2024, as there were no significant stock issuances compared to 2023[790]. Collaboration Agreements and Milestones - The company has not received any development, regulatory, or commercial milestone payments or royalties under any collaboration agreements to date[723]. - Genentech made an upfront payment of $11.0 million upon entering the original agreement and an additional $34.5 million during the Restated Genentech Agreement[743]. - The company is eligible to receive up to $44.0 million per Target upon achieving specified development milestones and up to $60.0 million per PROTAC targeted protein degrader upon achieving specified sales milestones[743]. General and Administrative Expenses - General and administrative expenses are expected to increase as the company expands personnel to support research and development activities[752]. - General and administrative expenses rose to $165.4 million in 2024, up $65.1 million from $100.3 million in 2023, largely due to a loss on lease termination and increased personnel costs[773]. Tax and Operating Losses - The company has not recorded any U.S. federal or state income tax benefits for net losses incurred since inception in 2013[754]. - As of December 31, 2024, the company had $111.0 million of federal net operating loss carryforwards, which may be carried forward indefinitely[755]. Future Plans and Requirements - The company plans to expand its PROTAC Discovery Engine and advance additional product candidates into preclinical and clinical development[793]. - Future capital requirements will depend on various factors, including the success of collaborations with Pfizer and Genentech[798]. - The company must maintain its location in Connecticut until September 2028 under the 2018 Assistance Agreement, with penalties for non-compliance[799].

Financial Data and Key Metrics Changes - The company reported $59.2 million in revenue for Q4 2024, a significant increase from a negative $43.1 million in Q4 2023, resulting in a $102.3 million change [39] - For the full year 2024, revenue reached $263.4 million, compared to $78.5 million in 2023 [40] - Cash, cash equivalents, and marketable securities at the end of Q4 2024 were just over $1 billion, down from $1.3 billion at the end of 2023 [38] Business Line Data and Key Metrics Changes - The company is advancing its vepdegestrant (vepdeg) program, with ongoing Phase 3 trials and plans for combination trials in 2025 [10][13] - Research and development expenses for Q4 2024 were $83.3 million, a decrease from $95.2 million in Q4 2023, primarily due to a net decrease in external expenses [41] - General and administrative expenses for Q4 2024 were $34.1 million, up from $27 million in Q4 2023, driven by costs related to commercial operations and personnel [40] Market Data and Key Metrics Changes - The company is focused on the oncology and neuroscience markets, with significant advancements in its PROTAC platform aimed at treating various cancers and neurodegenerative diseases [9][10] - The upcoming Phase 3 trial results for vepdeg are expected to influence the treatment landscape for ER-positive/HER2-negative breast cancer [11][12] Company Strategy and Development Direction - The company aims to transition to a commercial stage with the potential approval of its first PROTAC degrader, vepdeg, pending positive trial results [11][45] - Plans include initiating Phase 3 combination trials for vepdeg with CDK4 inhibitors in both first- and second-line settings in 2025 [13][21] - The company is also advancing its neuroscience pipeline, including ARV-102 for neurodegenerative diseases, with first-in-human data expected in April 2025 [14][26] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming topline data from the VERITAC-2 trial, which could mark a significant milestone for the company [11][45] - The company is well-capitalized to support operations into 2027, allowing for continued investment in its clinical programs [38][42] - Management highlighted the importance of addressing unmet medical needs in both oncology and neuroscience [9][14] Other Important Information - The company is preparing for its first commercial launch and is focused on building its commercial organization [70] - There was a leadership change with the departure of the Chief Commercial Officer, but the company has a capable interim replacement [110] Q&A Session Summary Question: What is the cadence of data from TACTIVE-U cohorts? - Management indicated that data from TACTIVE-U will mature over time, and updates will be shared as they become available [53][55] Question: What level of degradation is considered therapeutic for LRRK2? - Management stated that a 50% reduction of LRRK2 is considered disease-modifying based on preclinical data [58][60] Question: What data is needed to gain confidence from KOLs on the vepdeg and atirmociclib combination? - Management noted that KOLs would expect to see more than 5-6 months of improvement in median PFS to consider the combination substantially different [91] Question: How does the company view the competitive landscape for the KRAS G12D degrader? - Management expressed confidence in their KRAS degrader's potency and differentiated mechanism of action compared to competitors [95][96] Question: What is the enrollment status for ARV-393? - Management reported that enrollment is progressing well, with a focus on non-Hodgkin lymphoma patients [104][106] Question: How is the company preparing for the commercial launch? - Management confirmed that significant planning is underway for the commercial organization, with a focus on collaboration with Pfizer [70][110]

Exhibit 99.1 Arvinas Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update – Announced that topline data from the monotherapy Phase 3 VERITAC-2 trial is anticipated in 1Q25 – Vepdegestrant: Oral PROTAC ER degrader • Announced that the VERITAC-2 Phase 3 monotherapy clinical trial evaluating vepdegestrant in ER+/HER2- metastatic breast cancer remains on track, with topline data anticipated in 1Q25 (ClinicalTrials.gov Identifier: NCT05654623). • Announced plans to initiate t ...

NEW HAVEN, Conn., Feb. 03, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (NASDAQ:ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that management will review fourth quarter and full year ended 2024 financial results and provide a corporate update during a live webcast on Tuesday, February 11, 2025, at 8:00 a.m. ET. The webcast can be accessed under "Events and Presentations" on the investor page of the Arvinas website. A replay of th ...

Investors looking for stocks that could make dramatic moves in a short, defined time frame will want to turn their attention toward two innovative drugmakers. A couple of stocks in the volatile biopharmaceutical industry are poised to soar by the end of March.Results from clinical trials that wrap up soon could soon push shares of Recursion Pharmaceuticals (RXRX 2.03%), and Arvinas (ARVN 2.67%) through the roof. Both companies are expected to report their highly anticipated data any day now.Before you get e ...

Core Insights - Arvinas, Inc. is advancing its clinical programs with a focus on vepdegestrant, a PROTAC protein degrader targeting ER+/HER2- breast cancer, with significant milestones expected in 2025 [1][10][11] Clinical Trials and Data - A Phase 3 trial combining vepdegestrant with Pfizer's CDK4 inhibitor atirmociclib is set to begin in 2025, alongside a second-line Phase 3 trial with a CDK4/6 inhibitor [1][3] - Topline data from the Phase 3 VERITAC-2 trial of vepdegestrant monotherapy is anticipated in the first quarter of 2025 [1][5] - Initial data from the Phase 1 trial of ARV-102, a PROTAC LRRK2 degrader for Parkinson's disease, is expected in the first half of 2025 [2][4] Corporate Developments - Alex Santini has been appointed interim Chief Commercial Officer effective January 17, 2025, bringing over 30 years of experience in commercial organizations [7] - John Northcott, the outgoing Chief Commercial Officer, is leaving the company for personal reasons, also effective January 17, 2025 [8][9] Future Plans - The company plans to file an Investigational New Drug (IND) application for a novel PROTAC KRAS G12D degrader in 2025 [6] - Data disclosures are anticipated from multiple clinical and pre-clinical programs, including ARV-102 and ARV-393 [1][2]

NEW HAVEN, Conn., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Noah Berkowitz, M.D., Ph.D., Chief Medical Officer and Andrew Saik, Chief Financial Officer will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3 at 2:30 p.m. ET in New York. A live audio webcast of the presentation will be available here an ...

NEW HAVEN, Conn., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN) today announced that three posters for vepdegestrant, including clinical data, will be presented at the 2024 San Antonio Breast Cancer Symposium (SABCS), being held December 10-13, 2024, in San Antonio, Texas. Vepdegestrant is a novel investigational PROTAC estrogen receptor (ER) degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic estrogen re ...

Core Insights - Clearside Biomedical, Inc. has entered a commercial collaboration agreement with Arctic Vision and Santen Pharmaceutical Co., Ltd. for the commercialization of ARVN001 (XIPERE®) in China, targeting uveitic macular edema and other ophthalmic indications [1][2] - The partnership is expected to enhance the validation of Clearside's Suprachoroidal Space (SCS®) delivery platform, which is gaining traction among global pharmaceutical companies [2][3] - Arctic Vision has reported positive Phase 3 trial results for ARVN001 in China and is pursuing regulatory approvals in multiple Asia-Pacific countries [3] Company Overview - Clearside Biomedical specializes in innovative drug delivery systems for ocular diseases, utilizing its proprietary SCS Microinjector® to administer therapies directly to the back of the eye [5][9] - The company’s lead product, XIPERE®, is a corticosteroid suspension approved in the U.S. for treating macular edema associated with uveitis, and is commercially available through Bausch + Lomb [6][9] - Clearside is also developing a pipeline of small molecule candidates for ocular conditions, with its lead program, CLS-AX, for wet age-related macular degeneration, recently completing a Phase 2b trial [9] Market Context - Uveitis affects approximately 350,000 patients in the U.S. and over one million globally, with about one-third developing uveitic macular edema, a significant cause of vision loss [8] - The uveitis market is projected to grow to nearly $550 million in the U.S. and over $1 billion globally by 2024 [8]