Arvinas (ARVN) FY2025 10-K Risk Factors: 7 New, 15 Dropped

What the changes say

Arvinas reduced its workforce by 33% in April 2025 and 15% in September 2025 to streamline operations.

What changed since the prior 10-K

New

NewRisks Related to Our Financial Position and Need For Additional Capital
Our cost savings plan and the associated workforce reductions implemented in April 2025 and September 2025 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business
The company reduced its workforce by 33% in April 2025 and an additional 15% in September 2025, which may not achieve anticipated savings.
NewRisks Related to Our Financial Position and Need For Additional Capital
Income, sales, use or other tax laws, statutes, rules, or regulations could be enacted or amended at any
The 1% excise tax on stock repurchases under the Inflation Reduction Act could apply to non-traditional stock transactions.
NewRisks Related to Dependence on Third Parties
may also have the opportunity to collaborate on other product candidates or technologies for similar indications and will have to evaluate whether such a collaboration could be more attractive than one with us
Exclusive licenses with Genentech, Pfizer, and Novartis restrict the company from partnering with other parties for those specific protein targets and compounds.
NewRisks Related to Dependence on Third Parties
not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization efforts
The company relies entirely on third-party contract manufacturers for drug substances and finished products, having no internal manufacturing facilities.
NewRisks Related to Dependence on Third Parties
Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis
Loss and retirement of FDA leadership could delay guidance, reviews, and approvals for product candidates.
NewRisks Related to Our Intellectual Property
privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance efforts
Compliance with healthcare laws involves substantial costs, and violations could result in significant fines, imprisonment, or exclusion from Medicare and Medicaid.
NewRisks Related to Our Intellectual Property
identifiers, precise geolocation data, biometric identifiers, human genomic data, personal health data, and personal financial data
The Protecting Americans' Data from Foreign Adversaries Act prohibits transferring sensitive data like genetic information to China, Russia, Iran, and North Korea.

Dropped

DroppedRisks Related to Our Financial Position and Need For Additional Capital
Changes in tax laws or in their implementation or interpretation may adversely affect our business and financial condition
DroppedRisks Related to Our Financial Position and Need For Additional Capital
carryforwards may be carried forward indefinitely, but the deductibility of such carryforwards is limited to 80% of our taxable income in the year in which carryforwards are used
DroppedRisks Related to the Discovery and Development of Our Product Candidates
ARV-393, ARV-102, we may not be able to complete clinical development of vepdegestrant, ARV-393 or ARV-102 on our current timeline or at all
DroppedRisks Related to Dependence on Third Parties
If our collaboration with Pfizer is not successful, we may not be able to capitalize on the market potential of vepdegestrant
DroppedRisks Related to Dependence on Third Parties
payments based on specified regulatory and sales-based milestones for the Licensed Products under the Vepdegestrant (ARV-471) Collaboration Agreement
DroppedRisks Related to Our Intellectual Property
regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained
General tax law changes and reference to the Tax Cuts and Jobs Act.
DroppedRisks Related to Our Intellectual Property
preclude our obtaining marketing approval or prevent or limit commercial use. New oncology drugs frequently are indicated only for patient populations that have not responded to an existing therapy or have relapsed
DroppedRisks Related to Our Intellectual Property
changes introduced by the Windsor Framework will see the MHRA be responsible for approving all medicinal products destined for the United Kingdom market (i.e., Great Britain and Northern Ireland), and the EMA will no longer have any role in approving medicinal products destined for Northern Ireland
Limitations on net operating loss carryforwards under Sections 382 and 383.
DroppedRisks Related to Our Intellectual Property
notice to residents regarding retention of information. The provisions in the CPRA may apply to some of our business activities
DroppedRisks Related to Our Intellectual Property
and the GDPR, respectively. Any changes or updates to these adequacy decisions have the potential to impact our business
DroppedRisks Related to Our Intellectual Property
new law also caps Medicare beneficiaries' out-of-pocket drug costs at an estimated $4,000 a year in 2024 and, thereafter beginning in 2025, at $2,000 a year
DroppedRisks Related to Employee Matters and Managing Growth
We will need to grow the size of our organization, and we may experience difficulties in managing this growth, which could disrupt our operations
DroppedRisks Related to Employee Matters and Managing Growth
In addition, we may collaborate with third parties that have direct sales forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales force and distribution systems
DroppedRisks Related to Our Common Stock
In September 2021, we issued 3,457,815 shares of our common stock to Pfizer
DroppedRisks Related to Our Common Stock
stock could result in higher than average trading volume and may cause the market price for our common stock to decline

Reworded

89% rewrittenRisks Related to Our Financial Position and Need For Additional Capital
In the future, we might not be able to utilize a significant portion of any net operating loss carryforwards and research and development tax credit carryforwards we may have
Updated federal and state net operating loss carryforward figures to $533.6 million and $563.2 million as of December 31, 2025.
87% rewrittenRisks Related to Our Common Stock
If a significant portion of our total outstanding shares are sold into the market, the market price of our common stock could drop significantly, even if our business is doing well
Added specific mention of outstanding options, restricted stock units, and derivative securities that could cause further stock price declines.
83% rewrittenRisks Related to Dependence on Third Parties
Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results
Added specific 2025 tariff rates of 20% for China and 18% for India, plus a proposed 100% tariff on imported branded drugs.
80% rewrittenRisks Related to Our Intellectual Property
The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our drug products, if and when approved
Added reference to the October 2020 final rule allowing Section 804 Importation Programs to import prescription products from Canada.
77% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
We have conducted, and may in the future conduct, clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations
Listed specific foreign countries where clinical trials have been conducted, including Spain, Germany, France, Georgia, the UK, Netherlands, Canada, and Denmark.
Was: We plan to conduct clinical trials for our product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations
72% rewrittenRisks Related to Dependence on Third Parties
We rely and expect to continue to rely on third parties, including CROs, to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials
Updated the list of product candidates for which third-party CROs conduct trials, adding ARV-806, ARV-027, ARV-6723, and pan-KRAS.
Was: We rely and expect to continue to rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials
72% rewrittenRisks Related to Employee Matters and Managing Growth
Our future success depends on our ability to retain key employees, consultants and advisors, as well as our ability to attract, train, retain and motivate qualified personnel
Minor phrasing update removing 'offer letters' and retaining only 'employment agreements' regarding executive officers.
Was: Our future success depends on our ability to retain key employees, consultants and advisors and to attract, train, retain and motivate qualified personnel
71% rewrittenRisks Related to Our Intellectual Property
Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed outside of the United States and may limit our ability to generate revenue from product sales
Minor abbreviation change from 'European Union' to 'EU' regarding foreign marketing approvals.
68% rewrittenRisks Related to Our Intellectual Property
Similar restrictions apply to the approval of our products in the EU. The holder of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products
Was: Similar restrictions apply to the approval of our products in the European Union. The holder of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products
57% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success
57% rewrittenRisks Related to Our Intellectual Property
The regulatory approval process of the FDA is lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed
53% rewrittenRisks Related to Our Financial Position and Need For Additional Capital
We have incurred significant losses since our inception. We expect to incur expenses and operating losses over at least the next several years and may never achieve or maintain profitability
Was: We have incurred significant losses since our inception. We expect to incur losses over at least the next several years and may never achieve or maintain profitability
52% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
We do not have any product candidates that have been approved for commercialization. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed
Was: We are early in our development efforts. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed
41% rewrittenRisks Related to Our Intellectual Property
Social media platforms and AI-based platforms present new risks and challenges to our business
Was: Social media platforms and Artificial Intelligence, or AI, based platforms present new risks and challenges to our business
39% rewrittenRisks Related to Our Intellectual Property
Current and future legislation may increase the difficulty and cost for us and any collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain
39% rewrittenRisks Related to Our Intellectual Property
The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses
36% rewrittenRisks Related to Our Financial Position and Need For Additional Capital
We will need substantial additional funding to continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce or terminate our research or product development programs or future commercialization efforts
31% rewrittenRisks Related to Our Intellectual Property
Changes in patent laws or patent jurisprudence could diminish the value of our patents in general, thereby impairing our ability to protect our product candidates
26% rewrittenRisks Related to Our Common Stock
Because we have never paid and do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, and any cash expended via our share repurchase program, will be our stockholders’ sole source of gain
Was: Because we have never paid and do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be our stockholders’ sole source of gain
24% rewrittenRisks Related to Our Financial Position and Need For Additional Capital
Our limited operating history may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability
23% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
Our approach to the discovery and development of product candidates based on our PROTAC technology platform is unproven, which makes it difficult to predict the time, cost of development and likelihood of successfully developing any products

All 61 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Position and Need For Additional Capital

01We have incurred significant losses since our inception. We expect to incur expenses and operating losses over at least the next several years and may never achieve or maintain profitability53% rewritten
02We have never generated revenue from product sales and may never be profitable
03We will need substantial additional funding to continue our operations. If we are unable to raise capital when needed, we may be required to delay, limit, reduce or terminate our research or product development programs or future commercialization efforts36% rewritten
04Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates
05Our limited operating history may make it difficult for our stockholders to evaluate the success of our business to date and to assess our future viability24% rewritten
06Our cost savings plan and the associated workforce reductions implemented in April 2025 and September 2025 may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our businessNew
07Income, sales, use or other tax laws, statutes, rules, or regulations could be enacted or amended at anyNew
08In the future, we might not be able to utilize a significant portion of any net operating loss carryforwards and research and development tax credit carryforwards we may have89% rewritten

Risks Related to the Discovery and Development of Our Product Candidates

09Our approach to the discovery and development of product candidates based on our PROTAC technology platform is unproven, which makes it difficult to predict the time, cost of development and likelihood of successfully developing any products23% rewritten
10We do not have any product candidates that have been approved for commercialization. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed52% rewritten
11Drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
12If SAEs, undesirable side effects, or unexpected characteristics are identified during the development of any product candidates we may develop, we may need to abandon or limit our further clinical development of those product candidates
13Interim top-line and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data
14If we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary marketing approvals could be delayed or prevented
15We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success57% rewritten
16We have conducted, and may in the future conduct, clinical trials for product candidates at sites outside the United States, and the FDA may not accept data from trials conducted in such locations77% rewritten
17We may not be successful in our efforts to identify or discover additional potential product candidates
18We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do
19For specific information regarding competition to our product candidates, see “Item 1. Business—Competition” in this Annual Report on Form 10-K

Risks Related to Dependence on Third Parties

20may also have the opportunity to collaborate on other product candidates or technologies for similar indications and will have to evaluate whether such a collaboration could be more attractive than one with usNew
21We rely and expect to continue to rely on third parties, including CROs, to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials72% rewritten
22not have sufficient quantities of our product candidates or products or such quantities at an acceptable cost or quality, which could delay, prevent or impair our development or commercialization effortsNew
23Our current and anticipated future dependence upon others for the manufacture of our product candidates or products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basisNew
24Changes in U.S. and international trade policies, particularly with respect to China, may adversely impact our business and operating results83% rewritten

Risks Related to the Commercialization of Our Product Candidates

25Even if any of our product candidates receives marketing approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success
26If we are unable to establish sales and marketing capabilities, we may not be successful in commercializing our product candidates if and when they are approved
27Even if we are able to commercialize any product candidates, the products may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, which would harm our business
28Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop

Risks Related to Our Intellectual Property

29Changes in patent laws or patent jurisprudence could diminish the value of our patents in general, thereby impairing our ability to protect our product candidates31% rewritten
30We may become involved in lawsuits to protect or enforce our patents, the patents of our licensors, or other intellectual property, which could be expensive, time-consuming and unsuccessful
31We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms or at all
32Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business
33If we fail to comply with our obligations in our current and future intellectual property licenses and funding arrangements with third parties, we could lose rights that are important to our business
34We may be subject to claims by third parties asserting that our employees, consultants, contractors or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property
35Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities
36Obtaining and maintaining our patent protection depends on compliance with various procedural, documentary, fee payment and other requirements imposed by governmental patent offices, and our patent protection could be reduced or eliminated for non-compliance with these requirements
37If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
38If we are not able to obtain patent term extensions in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the term of our marketing exclusivity for our product candidates, our business may be impaired
39We only have limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world
40The regulatory approval process of the FDA is lengthy, time-consuming and inherently unpredictable, and if we are ultimately unable to obtain marketing approval for our product candidates, our business will be substantially harmed57% rewritten
41Failure to obtain marketing approval in foreign jurisdictions would prevent our product candidates from being marketed outside of the United States and may limit our ability to generate revenue from product sales71% rewritten
42We may seek certain designations for our product candidates, including Breakthrough Therapy, Fast Track and Priority Review, designations in the United States, but we might not receive such designations, and even if we do, such designations may not lead to a faster development or regulatory review or approval process
43Even if we obtain regulatory approval for a product candidate, our products will remain subject to regulatory oversight
44The FDA, EMA and other regulatory authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses39% rewritten
45Similar restrictions apply to the approval of our products in the EU. The holder of the marketing authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of medicinal products68% rewritten
46privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus complicating compliance effortsNew
47identifiers, precise geolocation data, biometric identifiers, human genomic data, personal health data, and personal financial dataNew
48Current and future legislation may increase the difficulty and cost for us and any collaborators to obtain marketing approval of and commercialize our product candidates and affect the prices we, or they, may obtain39% rewritten
49The prices of prescription pharmaceuticals in the United States and foreign jurisdictions are subject to considerable legislative and executive actions and could impact the prices we obtain for our drug products, if and when approved80% rewritten
50If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could significantly harm our business
51Social media platforms and AI-based platforms present new risks and challenges to our business41% rewritten

Risks Related to Employee Matters and Managing Growth

52Our future success depends on our ability to retain key employees, consultants and advisors, as well as our ability to attract, train, retain and motivate qualified personnel72% rewritten
53Our employees, independent contractors, vendors, principal investigators, CROs, CMOs, CDMOs, and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements, privacy laws and insider trading laws, which could materially harm our business

Risks Related to Our Common Stock

54The price of our common stock is volatile and may fluctuate substantially, which could result in the loss of all or part of our stockholders’ investment
55We may be subject to securities litigation, which is expensive and could divert management attention
56Our executive officers, directors and principal stockholders, if they choose to act together, have the ability to significantly influence or control all matters submitted to stockholders for approval
57Provisions in our organizational documents and under Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management
58If securities or industry analysts do not publish research or reports about our business, or if they issue an adverse or misleading opinion regarding our stock, our stock price and trading volume could decline
59If a significant portion of our total outstanding shares are sold into the market, the market price of our common stock could drop significantly, even if our business is doing well87% rewritten
60We will continue to incur significant costs as a result of operating as a public company, and our management will be required to devote substantial time to any new compliance initiatives and corporate governance practices
61Because we have never paid and do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, and any cash expended via our share repurchase program, will be our stockholders’ sole source of gain26% rewritten

Other Arvinas 10-Ks

FY2024 10-K risk factors
69 risks
Arvinas faces substantial ongoing financial losses and an accumulated deficit of $1,531.6 million as of December 31, 2024. The company relies entirely on its unproven PROTAC technology platform and key partnerships, such as the Pfizer collaboration for vepdegestrant. Development efforts center on clinical assets including vepdegestrant, ARV-393, ARV-102, and bavdegalutamide.
Filed Feb 11, 2025

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.