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Last Updated: January 7, 2025

SPIKEVAX Drug Profile


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Summary for Tradename: SPIKEVAX
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for SPIKEVAX
Recent Clinical Trials for SPIKEVAX

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Leiden University Medical CenterPhase 2

See all SPIKEVAX clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for SPIKEVAX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SPIKEVAX Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for SPIKEVAX Derived from Patent Text Search

No patents found based on company disclosures

SPIKEVAX Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SPIKEVAX (Moderna's COVID-19 Vaccine)

Introduction

Moderna's SPIKEVAX, a messenger RNA (mRNA) COVID-19 vaccine, has been a pivotal player in the global response to the COVID-19 pandemic. However, as the pandemic transitions into an endemic phase, the market dynamics and financial trajectory of SPIKEVAX have undergone significant changes.

Market Transition from Pandemic to Endemic

The COVID-19 pandemic saw an unprecedented demand for vaccines, with SPIKEVAX being one of the leading vaccines globally. However, as vaccination rates have increased and the pandemic has transitioned into an endemic phase, the demand for COVID-19 vaccines has decreased substantially[1][3][4].

Sales Performance

2023 Financial Year

In 2023, Moderna reported $6.7 billion in SPIKEVAX sales, a significant decline from the $19.3 billion reported in 2022. This drop was primarily due to lower vaccination rates and the fulfillment of advanced purchase agreements that were deferred from 2022[1][3].

Quarterly Performance in 2024

  • First Quarter 2024: SPIKEVAX sales were $167 million, with $100 million from the U.S. and $67 million from international sales. This represents a 91% decline compared to the same period in 2023[4].
  • Second Quarter 2024: Sales were $184 million, including $162 million from the U.S., reflecting a 37% decrease from the same period in 2023[5].
  • Third Quarter 2024: Sales saw a slight increase driven by higher sales in the U.S. market, but international sales were lower. The total net product sales for the quarter were $1.8 billion, with a small portion attributed to the launch of the RSV vaccine[2].

Market Share and Competitive Landscape

Despite the decline in sales, Moderna has maintained a significant market share in the U.S. retail segment. In the fall 2023 COVID season, Moderna achieved a 48% cumulative market share in the U.S., up from 37% in 2022[1].

Geographic Revenue Breakdown

United States

In 2023, the U.S. market generated $1.7 billion in revenues from SPIKEVAX, a decline of 79.3% from the peak of $5.4 billion in 2021. Moderna is focusing on increasing vaccination coverage rates and aligning vaccine approvals with flu vaccine seasons to boost sales[3][4].

Europe

European revenues from SPIKEVAX also declined significantly, from $5.4 billion in 2021 to $1.4 billion in 2023, representing an 81.4% decrease. However, there is interest from the EU for Moderna's new mRNA COVID-19 vaccine, with a pledge to purchase up to 36 million doses per year for the first four years after approval[3].

Rest of the World

The Rest of the World segment generated $3.6 billion in revenues in 2023, all from SPIKEVAX sales. This region remains crucial for Moderna's global sales strategy[3].

Financial Impact

Revenue Decline

The total revenue for Moderna in 2023 was $6.8 billion, down from $19.3 billion in 2022. This decline is primarily attributed to the reduced sales of SPIKEVAX[1][3].

Net Income and Earnings Per Share

In 2023, Moderna reported a net loss of $4.7 billion, compared to a net income of $8.4 billion in 2022. The diluted loss per share for 2023 was $(12.33), a significant drop from the diluted earnings per share of $20.12 in 2022[1].

Cash Position

As of December 31, 2023, Moderna's cash, cash equivalents, and investments were $13.3 billion, down from $18.2 billion at the end of 2022. The decrease is largely due to the operating loss and stock repurchases during the first half of 2023[1].

Strategic Adjustments

To adapt to the endemic market, Moderna has taken several strategic steps:

  • Manufacturing Footprint: Resized its manufacturing footprint to improve cash flow[1].
  • Commercial Structure: Flattened its commercial structure to drive sales execution[1].
  • Investment Focus: Focused investments on near-term growth drivers[1].

Pipeline Advancements

Moderna is diversifying its product pipeline to reduce dependence on SPIKEVAX. Key developments include:

  • RSV Vaccine: Expected to be approved and launched in several markets in 2024 and 2025[1][2].
  • Other Pipeline Products: Several late-stage products, including vaccines for Epstein-Barr virus, Varicella-Zoster virus, and norovirus, are advancing towards Phase 3 clinical trials[4].

Future Outlook

Revenue Projections

For 2024, Moderna forecasts product sales in the range of $3.0 to $3.5 billion from its respiratory franchise, with a focus on the RSV vaccine and updated COVID-19 vaccines[5].

Cost and Expense Management

The company anticipates research and development expenses of approximately $4.5 billion for 2024 and is managing costs to ensure financial discipline[4].

Key Takeaways

  • Market Transition: The transition from a pandemic to an endemic phase has significantly impacted SPIKEVAX sales.
  • Geographic Performance: The U.S. and European markets have seen substantial declines, while the Rest of the World remains a key revenue generator.
  • Financial Performance: Moderna has reported significant declines in revenue and net income due to lower vaccination rates.
  • Strategic Adjustments: The company is adapting its manufacturing, commercial structure, and investment strategies.
  • Pipeline Diversification: Moderna is advancing several new products to reduce dependence on SPIKEVAX.

FAQs

Q: What was the total revenue from SPIKEVAX sales in 2023?

A: The total revenue from SPIKEVAX sales in 2023 was $6.7 billion[1].

Q: How has Moderna's market share in the U.S. retail segment changed?

A: Moderna's market share in the U.S. retail segment increased to 48% in the fall 2023 COVID season, up from 37% in 2022[1].

Q: What are the key pipeline products Moderna is developing?

A: Moderna is developing an RSV vaccine, as well as vaccines for Epstein-Barr virus, Varicella-Zoster virus, and norovirus, among others[1][4].

Q: How has Moderna's cash position changed in 2023?

A: Moderna's cash, cash equivalents, and investments decreased from $18.2 billion at the end of 2022 to $13.3 billion at the end of 2023[1].

Q: What are Moderna's revenue projections for 2024?

A: Moderna forecasts product sales in the range of $3.0 to $3.5 billion from its respiratory franchise for 2024[5].

Sources

  1. Moderna Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Business Updates - Moderna Investors[1]
  2. Moderna Reports Third Quarter 2024 Financial Results and Provides Business Updates - BioSpace[2]
  3. Krause Fund Research - Moderna - University of Iowa Tippie College of Business[3]
  4. Moderna Reports First Quarter 2024 Financial Results and Provides Business Updates - Moderna Investors[4]
  5. Moderna Reports Second Quarter 2024 Financial Results and Provides Business Updates - Accesswire[5]

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