Avidity Biosciences, Inc. (RNA) Business Model Canvas

Avidity Biosciences, Inc. (RNA): Business Model Canvas [Dec-2025 Updated]

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You're looking at Avidity Biosciences right at the inflection point: the definitive $12 billion Novartis deal fundamentally changes the game from a pure clinical-stage play to a massive payday, even as they plan to spin out early cardiology assets. Honestly, the core story remains the proprietary Antibody Oligonucleotide Conjugates (AOCs™) platform, which is now powering three late-stage muscle disease programs, with del-zota aiming for a Biologics License Application submission by year-end 2025. While the cost structure shows heavy R&D spend-$392.6 million through the first nine months of 2025-they've got the war chest, sitting on about $1.9 billion in cash, which is key for this transition. Let's break down exactly how this new structure-from their key partnerships to their revenue streams-looks under the hood.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Key Partnerships

You're looking at the cornerstone relationships that fuel Avidity Biosciences, Inc.'s (RNA) strategy, especially as the company moves toward a major acquisition and commercial readiness. These partnerships de-risk development and secure manufacturing capacity.

The most significant recent development is the definitive merger agreement with Novartis AG. This deal values Avidity Biosciences at approximately $12 billion on a fully diluted basis, based on the announcement in late October 2025. The transaction terms specify that holders of Avidity common stock will receive $72.00 per share in cash at closing, which represented a 46% premium to the closing share price on October 24, 2025. The enterprise value at the expected closing date is approximately $11 billion. The closing is anticipated in the first half of 2026, following the separation of early-stage precision cardiology programs into a new entity, SpinCo.

The company maintains critical, long-standing research collaborations that provide non-dilutive funding and external expertise for platform expansion.

Here's a quick comparison of the financial structures of the major R&D partnerships:

Partner Upfront/Initial Payment Total Potential Milestones Funding Responsibility (Post-Upfront)
Eli Lilly and Company $20.0 million (Upfront License Fee, 2019) Up to $410.0 million per target (Development/Regulatory/Commercial) Lilly leads clinical development, regulatory, and commercialization at its sole cost.
Bristol Myers Squibb (BMS) $100 million (Upfront: $60 million cash + $40 million stock purchase at $7.88/share) Up to $2.3 billion (Cumulative for cardiovascular targets) BMS funds all future clinical development, regulatory, and commercialization activities for the collaboration.

For the Eli Lilly and Company research collaboration and license agreement, Avidity Biosciences recognized a $10.0 million clinical development milestone in the third quarter of 2025. The total potential per target is structured with up to $60.0 million in development milestones, up to $140.0 million in regulatory milestones, and up to $205.0 million in commercialization milestones, plus tiered royalties from the mid-single to low-double digits on net sales.

The ongoing research collaboration and license agreement with Bristol Myers Squibb (BMS) is focused on cardiovascular targets. Collaboration revenues recognized in the third quarter of 2025 were part of a total of $12.5 million for the quarter. The total potential value for this expanded cardiovascular collaboration is up to $2.3 billion in milestone payments, which includes up to $1.35 billion in research and development milestones and up to $825 million in commercial milestones, alongside tiered royalties up to the low double-digits.

The strategic manufacturing partnership with Lonza is key for commercial supply readiness. Avidity Biosciences entered a Manufacturing Services Agreement on August 1, 2025, with Lonza for drug substance and drug product. This commitment includes a binding, non-cancellable portion of Avidity's rolling forecast, where the Company has committed to purchase a minimum number of batches from 2026 to 2028, representing approximately $620.0 million in Product during that period, net of nonrefundable reservation fees. The Agreement has a seven-year term ending on August 1, 2032.

For rare disease studies, the physical infrastructure for patient access is concentrated. Specifically for Duchenne Muscular Dystrophy (DMD), the patient base is managed through approximately 50 specialist centers, which account for about 80% of the patient population receiving care.

  • Avidity Biosciences reported total collaboration revenues of $12.5 million for Q3 2025.
  • The Lilly agreement includes tiered royalties ranging from the mid-single to low-double digits.
  • The BMS agreement includes tiered royalties up to the low double-digits.
  • The Lonza commitment covers the period from 2026 to 2028.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Key Activities

You're preparing to analyze a company transitioning from pure R&D to commercial readiness, which means the Key Activities section of the Business Model Canvas is all about execution speed and capital deployment. Here's the breakdown of what Avidity Biosciences, Inc. (RNA) is actively doing as of late 2025.

The core activity is advancing the three late-stage Antibody Oligonucleotide Conjugates (AOCs™) programs through clinical milestones while simultaneously preparing for market entry. This requires massive investment, reflected in the operating expenses.

Advancing Three Late-Stage Clinical Programs (del-zota, del-desiran, del-brax)

Avidity Biosciences, Inc. (RNA) is focused on delivering on its three lead neuromuscular programs. The progress is measured by trial completion and data readouts:

  • del-zota (DMD44): Received Breakthrough Therapy designation in July 2025.
  • del-desiran (DM1): Completed enrollment in the Phase 3 HARBOR™ trial in mid-2025.
  • del-brax (FSHD): Completed enrollment for the FORTITUDE™ biomarker cohort with 51 total participants in the first quarter of 2025.

The financial commitment to this advancement is clear in the R&D spend. Research and development expenses for the nine months ended September 30, 2025, reached $392.6 million, a significant jump from $208.0 million for the same period in 2024. Honestly, that's the cost of moving three shots on goal through late-stage trials.

Preparing a Biologics License Application (BLA) Submission for del-zota by year-end 2025

The initial plan was aggressive: a Biologics License Application (BLA) submission for del-zota by year-end 2025, which would have been the company's first BLA. However, the latest updates indicate a shift in the BLA plan for del-zota to 2026 for accelerated approval, following a pre-BLA meeting in October 2025. The dose selected for submission is 5 mg/kg every six weeks.

Expanding the Antibody Oligonucleotide Conjugates (AOCs™) platform technology

The AOC platform is being expanded beyond neuromuscular diseases into precision cardiology and other areas through partnerships. This platform activity is key to future value creation:

  • Advancing two wholly-owned precision cardiology candidates: AOC 1086 (targeting PLN cardiomyopathy) and AOC 1072 (targeting PRKAG2 Syndrome).
  • Preclinical data for these cardiology candidates demonstrated potent targeted knockdown of approximately 80% in cardiac PLN mRNA and PRKAG2 mRNA, respectively.
  • The platform is being leveraged in a research collaboration with Bristol Myers Squibb for up to five cardiovascular targets.

Building out global commercial infrastructure for a potential 2026 product launch

Avidity Biosciences, Inc. (RNA) is actively transitioning into a commercial organization to support potential launches starting in 2026. This operational build-out is a major Key Activity right now:

Here's the quick math on the cost of building out the commercial team and operations:

Financial Metric Amount as of Late 2025
Cash, Cash Equivalents, Marketable Securities (as of Sept 30, 2025) $1.9 billion
Cash Runway Expected To Mid-2028
Q3 2025 General & Administrative Expenses $46.3 million
Gross Proceeds from Sept 2025 Public Offering $690.0 million

The company is preparing for three potential product launches in rapid succession, starting in the U.S. in 2026. The General and administrative expenses for the third quarter of 2025 alone were $46.3 million, which reflects the investment in this global infrastructure.

Executing the planned spin-out of early-stage precision cardiology programs (SpinCo)

A critical corporate activity is the separation of the early-stage precision cardiology programs into a new, expected publicly traded entity, SpinCo. This is tied to the definitive merger agreement with Novartis, announced in October 2025, which is scheduled to close in the first half of 2026.

The terms for Avidity Biosciences, Inc. (RNA) shareholders include receiving $72 per share in cash, plus a distribution of SpinCo shares or cash proceeds from its sale. Kathleen Gallagher, currently Avidity's chief program officer, is set to lead SpinCo as its chief executive officer, while Sarah Boyce will serve as chair of the board.

Finance: draft 13-week cash view by Friday.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Key Resources

You're looking at the core assets Avidity Biosciences, Inc. (RNA) is leaning on to execute its strategy as of late 2025. These aren't just line items; they're the engine for their next phase.

Proprietary Platform and Technology

The foundation here is the proprietary Antibody Oligonucleotide Conjugates (AOCs™) platform technology. This approach is designed to combine the targeting specificity of monoclonal antibodies (mAbs) with the precision of oligonucleotide therapies. Avidity Biosciences demonstrated the first-ever successful targeted delivery of RNA into muscle tissue using this platform. Also, the company is advancing its pipeline through key partnerships, broadening the reach of AOCs into areas like cardiology and immunology.

Here's a look at the platform's advancement:

  • AOCs designed to access previously unreachable tissue and cell types.
  • Next-generation technology showed up to 30-fold improvements in delivery in preclinical studies.
  • The company is headquartered in San Diego, CA.

Financial Strength and Runway

Honestly, a strong balance sheet is a non-negotiable key resource for any clinical-stage company preparing for potential commercialization. Avidity Biosciences has maintained a robust financial position.

The latest figures show:

Financial Metric Amount as of September 30, 2025
Cash, Cash Equivalents, and Marketable Securities $1.9 billion
Estimated Cash Runway To mid-2028
Net Loss (Q3 2025) $174.44 million
Research and Development Expenses (9 Months Ended Sept 30, 2025) $392.6 million
General and Administrative Expenses (Q3 2025) $46.3 million
Collaboration Revenues (Q3 2025) $2.3 million

The company announced a definitive merger agreement with Novartis in October 2025, valuing Avidity Biosciences at approximately $12 billion in total equity value.

Intellectual Property and Talent

Protecting the AOCs™ drug class is critical; success depends on the intellectual property portfolio safeguarding these proprietary technologies. Beyond the patents, the human capital is a major asset.

Key talent areas supporting the platform and pipeline include:

  • Expertise in oligonucleotide chemistry.
  • Specialists in antibody engineering.
  • Deep knowledge in muscle biology.

This combination of IP and specialized personnel underpins the ability to move candidates through development.

Clinical Data Supporting Regulatory Filings

The clinical data from the lead programs provide the tangible evidence needed to support regulatory submissions. Avidity Biosciences is on track for three potential Biologics License Application (BLA) submissions over a 12-month period, with the first potential U.S. commercial launch anticipated in 2026.

Here's the status of the three lead neuromuscular programs:

Program (Indication) Key Data/Regulatory Milestone (as of late 2025)
del-zota (DMD exon 44 skipping) FDA Breakthrough Therapy designation (July 2025); Pre-BLA meeting completed (October 2025); BLA submission planned for 2026.
del-desiran (DM1) Phase 3 HARBOR™ trial enrollment completion anticipated mid-2025; BLA submission expected in the second half of 2026.
del-brax (FSHD) Positive initial data showed greater than 50% reduction in DUX4 regulated genes and mean 25% or greater reduction in creatine kinase.

The del-zota one-year data demonstrated sustained muscle protection, leading to meaningful improvement and reversal of disease progression across multiple key functional measures. Also, del-brax data showed consistent improvement compared to placebo on functional and quality of life measures.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Value Propositions

You're looking at the core value Avidity Biosciences, Inc. (RNA) brings to the table with its Antibody Oligonucleotide Conjugates (AOCs) platform. This technology is designed to solve the fundamental delivery problem for RNA therapies, specifically targeting muscle tissue.

The primary value proposition centers on the ability to deliver RNA therapeutics directly to previously inaccessible muscle tissue. This targeted delivery mechanism, using a proprietary monoclonal antibody to bind to the transferrin receptor 1 (TfR1) conjugated with a phosphorodiamidate morpholino oligomer (PMO), is what allows them to potentially treat the root cause of rare genetic muscle diseases.

For Duchenne muscular dystrophy with mutations amenable to exon 44 skipping (DMD44), the value is crystallized in the del-zota program:

  • Del-zota has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
  • The planned Biologics License Application (BLA) submission timeline was initially year-end 2025, but was revised following a pre-BLA meeting to Q1 2026.

The clinical data from the EXPLORE44® and EXPLORE44-OLE™ trials is what underpins this value. We see concrete, sustained biological and functional changes:

Measure Data Point (as of late 2025) Context
Dystrophin Production (Normal) Approximately 25% increase Statistically significant increase across dose cohorts.
Total Dystrophin Up to 58% of normal levels Reported one-year data.
Exon 44 Skipping Approximately 40% increase Reported in March 2025 data.
Creatine Kinase (CK) Reduction Greater than 80% reduction Sustained to near-normal levels for 16 months.

These molecular changes translate directly into functional benefits, which is a massive value driver. The data showed reversal of disease progression across multiple functional endpoints when compared to natural history:

  • Time to Rise from Floor improvement.
  • 4-Stair Climb improvement.
  • Performance of Upper Limb improvement.
  • 10-Meter Walk/Run Test improvement.

The platform's design also suggests maximized therapeutic durability, leading to infrequent dosing potential. The dose selected to support the BLA filing is 5 mg/kg every six weeks. This is a key differentiator from older modalities that might require more frequent administration.

To support this pipeline advancement, Avidity Biosciences, Inc. maintained a strong financial footing as of late 2025. As of September 30, 2025, cash, cash equivalents, and marketable securities totaled approximately $1.9 billion. The company reported trailing twelve-month revenue of $20.9M as of September 30, 2025, with Q3 2025 collaboration revenue reaching $12.5 million. Research and development expenses for Q3 2025 were $154.9 million. The market reflected this progress, with the market cap standing at $10.3B as of October 31, 2025.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Customer Relationships

You're preparing to launch therapies for serious, genetic neuromuscular diseases like DM1, FSHD, and DMD44, so managing relationships with every stakeholder-from patients to partners-is mission-critical. Here's how Avidity Biosciences, Inc. structures those connections as of late 2025.

High-touch, direct engagement with rare disease patient communities and foundations

Avidity Biosciences, Inc. grounds its development efforts in direct engagement with the communities it aims to serve. This isn't just public relations; it's integral to their mission to profoundly improve people's lives. Their optimism, courage, and insights fuel the work they do every day, as stated by the CEO in February 2025. This commitment is demonstrated through tangible support for advocacy efforts.

For Rare Disease Day on February 28, 2025, the company supported specific initiatives:

  • Supported the EveryLife Foundation for Rare Diseases "Rare Disease Week on Capitol Hill" which took place February 24-26, 2025 in Washington, D.C.
  • Sponsoring the Jett Foundation's webinar "Thriving with Duchenne," held on February 28, 2025.

The company is advancing clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD), and facioscapulohumeral muscular dystrophy (FSHD). This focus requires deep, ongoing dialogue with patient groups for these specific conditions.

Close, collaborative relationships with key opinion leaders (KOLs) and clinical investigators

The scientific credibility supporting the Antibody Oligonucleotide Conjugates (AOCs™) platform relies heavily on external experts. The structure for this involves building out field medical teams designed for scientific exchange. For instance, a Field Medical Affairs role involves overseeing engagement strategies with KOLs and developing field medical resources. The Chief Medical Officer, Dr. Steve Hughes, brings experience from contributing to over 50 clinical trials for more than 25 drugs, including several rare disease drugs, which lends significant weight to these scientific relationships. Furthermore, enrollment in the FORTITUDE biomarker cohort for del-brax was completed in the first quarter of 2025, ahead of original guidance, suggesting effective collaboration with clinical investigators.

Dedicated investor relations and communication due to high-growth biotech status

As Avidity Biosciences, Inc. prepares for potential launches-targeting three potential Biologics License Application (BLA) submissions over a 12-month period-investor communication is highly structured. Kat Lange joined in December 2024 to lead investor relations and business development. The company actively manages this relationship through regular updates and conference participation. For example, in the third quarter of 2025, management participated in three major investor events:

Conference Date (2025) Time Zone
Cantor Global Healthcare Conference September 3 PT/ET
Wells Fargo Healthcare Conference September 4 PT/ET
Morgan Stanley 23rd Annual Global Healthcare Conference September 8 PT/ET

Following the October 2025 announcement of the definitive merger agreement with Novartis, a dedicated conference call for investors was scheduled for October 27, 2025, at 1 pm CET. The company maintains its investor relations website as a means of disclosing material non-public information. As of June 30, 2025, the cash position stood at approximately $1.2 billion, with a cash runway extending to mid-2027, a key data point shared with investors to underscore financial stability.

Strategic management of pharmaceutical partners through joint steering committees

Avidity Biosciences, Inc. manages its strategic partnerships, notably the research collaboration and license partnership with Bristol Myers Squibb (BMS), through formal governance structures. This partnership is managed via a joint steering committee comprised of representatives from both Avidity Biosciences, Inc. and BMS. This structure is key to aligning on development strategy for the collaboration. The financial structure of this relationship is concrete, providing significant, non-dilutive funding.

Here are the key financial elements related to the BMS partnership:

Financial Component Amount
Upfront Payment Received Approximately $100 million
Nonrefundable Cash Payment Portion of Upfront $60 million
Stock Sale Portion of Upfront Approximately $40 million
Maximum R&D Milestone Payments Up to approximately $1.35 billion
Maximum Commercial Milestone Payments Up to approximately $825 million

The stock sale component included a premium of approximately $8.7 million over the fair value at the time of the transaction.

Specialized medical affairs team for future commercial product support

Preparing for what the CEO called a transformational year in 2025, Avidity Biosciences, Inc. began building out the infrastructure for commercial success. This included the explicit initiative of building global medical affairs and commercial teams devoted to serving the needs of the rare disease communities. Eric Mosbrooker expanded his role to Chief Commercial Officer (CCO) in January 2025 to lead multiple global product launches. The Medical Affairs team structure is designed to support this commercial readiness, including building field-based Medical Science Liaison (MSL) and Medical Value Liaison (MVL) teams. The MVL strategic planning specifically includes the payor engagement strategy. Research and development expenses for the first nine months of 2025 were $392.6 million, compared to $208.0 million for the same period in 2024, reflecting this aggressive investment in pipeline advancement and commercial infrastructure build-out.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Channels

You're looking at the channels Avidity Biosciences, Inc. (RNA) uses to reach customers and partners, which are rapidly evolving given the announced acquisition by Novartis. The primary focus shifts from building an independent commercial engine to leveraging a global partner's infrastructure for late-stage assets, while maintaining channels for earlier-stage and partnered programs.

Direct Sales Force and Distribution Network Post-Launch

Avidity Biosciences, Inc. is actively preparing for its first potential commercial launch in the U.S. in 2026, signaling the activation of a direct sales force and distribution network for its specialized therapies, primarily for Duchenne muscular dystrophy (DMD44) with del-zota. This preparation is underpinned by significant operational scaling, as evidenced by the General and administrative expenses for the nine months ended September 30, 2025, reaching $116.8 million. The company anticipates being on track for three potential BLA submissions over a 12-month period. Furthermore, commercial manufacturing readiness is being secured through a Lonza Manufacturing Services Agreement, which includes approximately $620 million in minimum batch commitments spanning from 2026-2028.

Academic Research Institutions and Clinical Trial Sites

The development channel relies heavily on clinical trial sites for generating the necessary data for market access. For the del-desiran program targeting myotonic dystrophy type 1 (DM1), the Phase 3 HARBOR trial is a global study conducted at approximately 40 sites globally. Enrollment for this trial was completed in July 2025. The del-brax program for facioscapulohumeral muscular dystrophy (FSHD) initiated a global confirmatory Phase 3 study, the FORWARD study. These sites serve as the critical interface for patient access and data collection for these specialized therapies.

Pharmaceutical Partners for Co-development and Global Reach

Avidity Biosciences, Inc. utilizes strategic pharmaceutical partnerships to expand the reach of its Antibody Oligonucleotide Conjugate (AOC) platform beyond its internal focus on rare neuromuscular diseases. The most significant channel shift is the definitive merger agreement with Novartis, announced in October 2025, for a total equity value of approximately $12 billion. This deal channels the late-stage neuroscience pipeline (del-zota, del-desiran, del-brax) directly into Novartis's global commercial and development capabilities, with closing expected in the first half of 2026.

The existing partnerships also function as key channels for indication expansion:

Partner Focus Area/Indication Upfront/Initial Consideration Total Potential Payments
Novartis Late-stage Neuroscience (DMD, DM1, FSHD) $12 billion (Acquisition Value) N/A (Acquisition)
Bristol Myers Squibb (BMS) Cardiovascular Targets $100 million ($60 million cash + stock purchase of $40 million at $7.88/share) Up to $2.3 billion
Eli Lilly and Company Immunology and Select Indications Not specified in latest data Not specified in latest data

For the BMS collaboration, Bristol Myers Squibb will fund all future clinical development, regulatory, and commercialization activities coming from that specific collaboration.

Regulatory Agencies for Market Access and Approvals

Regulatory agencies act as a critical gatekeeping channel for market entry. Avidity Biosciences, Inc. has established clear paths with the FDA for its lead candidates, supporting the planned 2026 launches.

  • FDA Breakthrough Therapy designation received for del-zota (DMD44).
  • Pre-BLA meeting with the FDA for del-zota was positive in October 2025.
  • BLA submission for del-zota is planned for Q1 2026.
  • FDA alignment achieved on accelerated and full approval pathways for del-brax (FSHD).
  • Marketing application submissions for del-desiran (DM1) are anticipated to start in the second half of 2026 in the U.S., E.U., and Japan.

Investor and Scientific Conferences for Data Dissemination and Capital Raising

Data dissemination channels include scientific conferences, where data from trials like MARINA-OLE™ (del-desiran) is expected to be presented in the fourth quarter of 2025, and FORTITUDE (del-brax) topline data is expected in Q2 2026. Capital raising and investor confidence channels are supported by the company's strong balance sheet. As of September 30, 2025, Avidity Biosciences, Inc. reported approximately $1.9 billion in cash, cash equivalents, and marketable securities. This liquidity position is expected to be sufficient to fund its operations to mid-2028.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Customer Segments

You're looking at the customer base for Avidity Biosciences, Inc. (RNA) as of late 2025, right before that big Novartis deal closed-a deal valuing the company at approximately $12 billion in equity value in October 2025. The customer segments are clearly defined by the rare neuromuscular diseases they are targeting with their Antibody Oligonucleotide Conjugate (AOC) platform.

The primary, most immediate customer segments are the patients themselves, where the company is building out global commercial infrastructure in anticipation of potential launches starting in 2026. The financial commitment to this readiness is clear: Research and development expenses for the first nine months of 2025 hit $392.6 million, showing the heavy investment required to bring these candidates to market.

Here's a breakdown of the patient populations Avidity Biosciences is focused on:

  • Patients with Myotonic Dystrophy Type 1 (DM1) for del-desiran (AOC 1001).
  • Patients with Duchenne Muscular Dystrophy (DMD) with Exon 44 skipping for del-zota.
  • Patients with Facioscapulohumeral Muscular Dystrophy (FSHD) for del-brax.
  • Large biopharmaceutical companies seeking novel RNA delivery platforms (e.g., Eli Lilly, BMS).

The scale of the opportunity for each drug candidate defines the patient segment size. For instance, the FSHD market alone is estimated to be worth $4-5 billion. The company's strong financial position, with approximately $1.9 billion in cash, cash equivalents, and marketable securities as of Q3 2025, is meant to fund the execution across these three late-stage programs and commercial launch preparations.

The patient segment details for the three lead programs are:

Therapeutic Area Product Candidate Estimated Patient Population (US & EU) Key Clinical Trial Enrollment/Scope
Myotonic Dystrophy Type 1 (DM1) del-desiran (AOC 1001) Estimated 80,000 people Phase 3 HARBOR™ trial evaluating approximately 150 people (age 16 and older)
DMD (Exon 44 Skipping) del-zota Estimated 6% of the Duchenne population Data from 26 participants in EXPLORE44 and 38 in OLE as of January 2025
Facioscapulohumeral Muscular Dystrophy (FSHD) del-brax Approximately 45,000 to 87,000 people FORTITUDE biomarker cohort enrolled 51 participants

Beyond the patients, Avidity Biosciences has significant customer segments in the form of strategic partners. These collaborations provide non-dilutive funding and validation for the AOC platform. You see this in the revenue recognition; Q3 2025 collaboration revenues were $12.5 million, which included a $10.0 million clinical development milestone from Eli Lilly and Company. Under the Lilly Agreement, for example, Eli Lilly is solely responsible for funding the cost of preclinical research, clinical development, regulatory approval, and commercialization for the Lilly AOCs.

The commitment to commercial readiness also points to a segment of specialized healthcare providers and centers. The company has a Lonza Manufacturing Services Agreement with minimum batch commitments of approximately $620 million spanning 2026-2028, which signals readiness to supply these specialized neuromuscular treatment centers. The projected U.S. sales for del-zota alone are estimated at approximately $400 million.

The company's financial health supports this multi-segment approach; as of June 30, 2025, cash and equivalents were about $1.2 billion, with a runway extending into mid-2027. That runway is key to managing the capital intensity of preparing for three potential BLA submissions over approximately 12 months.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Cost Structure

You're looking at the financial reality of a company deep in the clinical development phase, which means the cost structure is dominated by science and scale-up, not sales. Avidity Biosciences, Inc. is burning capital to advance its Antibody Oligonucleotide Conjugates (AOCs) platform, a necessary step before any potential revenue stream from product sales materializes. This is a capital-intensive business model by design.

Here are the key financial markers that define the current cost outlay for Avidity Biosciences, Inc. as of late 2025:

Cost Metric Period Amount (USD)
Research and Development (R&D) Expenses First Nine Months of 2025 $392.6 million
General and Administrative (G&A) Expenses Q3 2025 $46.3 million
Projected Net Loss Full Year 2025 Approximately $-675.4 million

The primary engine driving these substantial expenses is the simultaneous advancement of the pipeline. Honestly, the costs are climbing because the company is executing on its plan to become a commercial entity, which requires significant upfront investment in both the science and the infrastructure to support future launches. The R&D spend is the most visible component of this burn rate.

The major cost drivers feeding into this structure include:

  • High Research and Development (R&D) expenses, totaling $392.6 million for the first nine months of 2025.
  • Increasing General and Administrative (G&A) costs, hitting $46.3 million in Q3 2025, directly tied to building out the commercial infrastructure.
  • Significant manufacturing costs for clinical and commercial supply scale-up; this is reflected in the R&D increase and includes commitments like the Lonza Manufacturing Services Agreement with approximately $620 million in minimum batch commitments scheduled from 2026-2028.
  • The expense of running three concurrent late-stage global clinical trials for del-zota (DMD44), del-desiran (DM1), and del-brax (FSHD), each requiring extensive operational oversight and data management.

This heavy operational burn is what results in the capital-intensive model driving a projected net loss of approximately $-675.4 million for the 2025 fiscal year. Finance: draft 13-week cash view by Friday.

Avidity Biosciences, Inc. (RNA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Avidity Biosciences, Inc. (RNA) as of late 2025, and honestly, the story isn't about selling pills yet; it's all about the value locked up in their Antibody Oligonucleotide Conjugates (AOCs) platform through partnerships.

The bulk of Avidity Biosciences, Inc.'s current income comes from collaboration revenue, which is essentially non-product income from their strategic pharma deals. This revenue is lumpy, driven by hitting specific development milestones or receiving ongoing research funding. For instance, you saw a clear example in the third quarter of 2025, where Avidity Biosciences, Inc. booked a $10.0 million clinical development milestone payment from Eli Lilly and Company under their existing research collaboration and license agreement.

To be fair, these milestone payments are the lifeblood right now, but they aren't the only source. You should also factor in the ongoing research funding and other payments from strategic pharmaceutical partnerships, like the one with Bristol Myers Squibb. The total collaboration revenue for the third quarter ending September 30, 2025, hit $12.5 million, which was a massive jump from the $2.3 million in the same period last year. This shows the platform is actively delivering value to its partners.

Here's a quick look at how that collaboration revenue stacked up recently:

Metric Amount Period/Date
Total Trailing Twelve Months (TTM) Revenue $20.86 million As of December 2025
Collaboration Revenue (Q3 2025) $12.5 million Quarter ended September 30, 2025
Collaboration Revenue (First Nine Months 2025) $17.9 million Nine months ended September 30, 2025

The TTM revenue as of December 2025 stands at $20.86 million. That figure is a significant step up from the $10.89 million reported for the full year in 2024. It's defintely clear that the milestone achievements in 2025 are what's driving that top-line growth.

Looking ahead, the real potential for product sales revenue is tied to the three late-stage neuromuscular programs. Avidity Biosciences, Inc. is preparing for what they call three potential successive product launches starting in 2026, following regulatory approval for del-zota, del-desiran, and del-brax. For del-zota specifically, U.S. sales are projected to reach approximately $400 million at peak, assuming approval. You won't see this product sales revenue stream until post-regulatory approval, which is a key near-term catalyst.

Also, you need to track the planned SpinCo. This entity is being set up to hold Avidity Biosciences, Inc.'s early-stage precision cardiology programs. The revenue stream here is less certain but potentially lucrative, involving future licensing revenue or value capture from those early assets once SpinCo is operating independently. The structure suggests a mechanism to potentially monetize those cardiology programs separately from the main neuromuscular focus, which is currently being acquired by Novartis.

Here are the key future revenue drivers you need to keep on your radar:

  • Future product sales for del-zota, del-desiran, and del-brax.
  • Potential peak annual sales approaching $10 billion across all three lead assets if approved.
  • Monetization events from the planned SpinCo's cardiology pipeline.
  • Continued milestone and research payments from existing partners like Eli Lilly and Bristol Myers Squibb.

Finance: draft 13-week cash view by Friday.


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