IXIARO Drug Profile

Summary for Tradename: IXIARO

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for IXIARO

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Japanese Encephalitis Virus Vaccine
Chemical Structure	Japanese Encephalitis Vaccines Vaccines, Inactivated

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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 IXIARO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

IXIARO Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for IXIARO

Introduction to IXIARO

IXIARO, also known as JESPECT in some regions, is a Japanese encephalitis vaccine developed by Valneva. It has been gaining significant traction in the market, particularly in terms of sales and financial performance.

Market Access and Sales Growth

Sales Performance:

• First Nine Months of 2024: IXIARO sales reached €66.0 million, representing a 31% increase from €50.3 million in the same period of 2023[2][4].
• Geographic Expansion: Sales to both travelers and the U.S. military showed double-digit growth compared to the previous year[2][4].

Financial Highlights

Nine-Month Key Financial Highlights:

• Total Revenues: €116.6 million, including product sales of €112.5 million[2][4].
• Net Profit: €24.7 million, including proceeds from the Priority Review Voucher (PRV) sale[2][4].
• Operating Profit: €34.2 million, compared to an operating loss of €57.2 million in the first nine months of 2023[2][4].
• Cash Position: €156.3 million, with €61.2 million in gross proceeds from recent private placement[2][4].

Product Gross Margins

• IXIARO Gross Margin: 58.8%, with COGS of €27.2 million related to IXIARO product sales[2].
• Overall Gross Margin: 48.6%, excluding IXCHIQ, compared to 43.7% in the same period of 2023[2].

Supply Chain and Distribution

• Supply Shortages Resolution: Product gross margins continued recovering during the third quarter of 2024 as supply shortages during the first half were resolved[2].
• Distribution Agreement: Valneva has been supplying additional doses of IXIARO to the U.S. Department of Defense under a current contract, signed in September 2023[2].

Future Outlook

• Full-Year 2024 Financial Guidance: Expected total product sales between €160 million to €170 million, and total revenues between €170 million to €180 million[2].
• R&D Investments: Expected between €65 million and €75 million[2].
• Other Income: Expected between €100 million and €110 million, including €95 million from the PRV sale[2].

Strategic Pipeline Expansion

• Shigella Vaccine Candidate: Valneva secured an exclusive worldwide license for S4V2, a Shigella vaccine candidate, adding an attractive Phase 2 clinical asset to its R&D pipeline[2].
• Clinical and Regulatory Execution: The company has made significant strides in clinical and regulatory execution, including the launch of the world’s first chikungunya vaccine in Canada and Europe, with further potential approvals expected in Brazil (Q4 2024) and the UK (Q1 2025)[2].

Key Takeaways

1. Market Growth: IXIARO has shown significant market growth, with a 31% increase in sales in the first nine months of 2024.
2. Financial Performance: The vaccine has contributed substantially to Valneva’s financial performance, with a net profit of €24.7 million.
3. Supply Chain Management: Resolution of supply shortages has positively impacted product gross margins.
4. Future Prospects: Strong financial guidance and strategic pipeline expansion indicate a promising future for Valneva.

FAQs

1. What is IXIARO?

   • IXIARO is a Japanese encephalitis vaccine developed by Valneva.

2. How has IXIARO performed financially?

   • IXIARO has contributed €66.0 million in sales in the first nine months of 2024, with a net profit of €24.7 million.

3. What are the key factors driving IXIARO’s market growth?

   • Double-digit growth in sales to both travelers and the U.S. military, along with strategic distribution agreements.

4. How has Valneva managed its supply chain for IXIARO?

   • Valneva has resolved supply shortages, leading to improved product gross margins.

5. What are the future prospects for IXIARO and Valneva?

   • Strong financial guidance and strategic pipeline expansion indicate a promising future for both IXIARO and Valneva.

Sources:

1. Valneva Reports Nine-Month 2024 Financial Results and Provides Corporate Updates.
2. Understanding the Opportunity in Japan's Biosimilar Market.
3. Ixiaro, Japanese Encephalitis Vaccine (Inactivated, Adsorbed).