Exagen Inc (XGN)XGN

Exagen Inc. – Comprehensive Stock Overview

Company Profile:

• History:

  • Exagen Inc., a biotechnology firm, was initially incorporated in Delaware as Celator Pharmaceuticals Inc, in 2003.

  • It changed the name to Exagen Inc. on May 10, 2011. The company focuses on developing, commercializing, and selling molecular diagnostic tests.

  • Business:

    • Exagen Inc.’s main business areas include developing diagnostic tests and related solutions for personalized cancer treatment, transplant monitoring & care, and autoimmune and inflammatory disease assessment and monitoring.

  • Leadership & Corporate Structure:

    • CEO: Ron Rocca (appointed Aug-2020)
    • CFO: Christopher M. Waits (since March-2014); previously President, Exagen Diagnostics

Top Products:

• Avise CPRA - Detects antibodies to nuclear and cytoplasmic antigens. Useful as an initial screen and for monitoring autoimmune liver disorders.

• Avise HLA- Performs high resolution human HLA typing for transplantation selection, including bone, kidney, pancreas, lung & heart transplant. & ExaTEL-STAT-FISH™ - Detects Philadelphia chromosome, used for chronic leukemia testing.

• Avise PD-L1 (IHC/CPS)- Identifies and quantifies PD-L1 expression levels in non-small cell lung, bladder cancer and skin carcinoma.

• Avise CDx Assay (FISH)- A companion diagnostic for treatment with lorlatinib (Pfizer).

These products cater primarily to the US, European and international diagnostic and clinical market.

Market Share:

• While specific market share is difficult to pinpoint, Avise CPRA, HLA, PD-L1, and ExaTEL-FISH are key players within their segments.

Product Analysis:
* Exagen has a solid pipeline and diverse products addressing significant medical needs. However, competition remains high, and regulatory and marketing efforts are crucial for further market share gains in the global landscape.

TAM (Total Addressable Market:

• Oncology and Transplant Care:
  • Global cancer diagnostics, estimated at $44Bn by 2027
  • US transplant diagnostics, expected to reach $-4Bn. AutoImmune Disease Diagnostics:
    • US market projected for $46Bn by end 2025.

Financial Performance:

• Revenue:
• 2021 - $42.3 M 2022 - 40.3 M (YoY decline attributed primarily to one- time sales in 2021).
• EPS (Diluted ): 2021-(0.55) 2022-(0.38) * Operating loss in 2022, partially offset by an increase from the sale of Acellular Therapeutics Business. * * Profits impacted by R&D investments.
• Cash: $49 M as of 01-31 2023.

**Dividends: **

• **Exagen does NOT currently have a dividend policy.

** Growth Trajectory:**

• Historical: Exagen has shown strong 10-Yr CAGR (Compound Annual growth Rate), particularly for ExaTEL, C-PRA and ACD-DX (HLA typing and Acellular Cardiodiagnostics).

• Future Projections: Exagen's 2023 projected revenue of $54M points to an upward growth trend. Market penetration in key regions and new product offerings (Avise PD - L1 for skin carcinoma and Kidney transplant monitoring platform development) support future prospects.

Market Dynamics:

• Positive: Growing need for personalized medicine, increased focus on early cancer detection and minimally-invasive approaches, aging populations.

• Negative: Regulatory hurdles, constant technology updates, competitor dynamics. *

• **Exagen is well placed to leverage the market potential through its diversified offerings and ongoing R&D.

Competitors::

• Roche (#RHHBY - SWX ) - Global diagnostics and life-sciences giant.
• Illumina (#ILMN - Nasdaq ) - Sequencing-based diagnostic technology leader.
  * Abbott Labs (#ABT- NYSC ) - Diversified healthcare company with diagnostics operations.

Market Share Comparisons: * - **Exagen's niche focus makesdirect market share comparison with giants like Illumina, Roche or even Quest labs difficult, however they do compete for portions within their segments. ** * - * Competition for Exagen is most prominent from companies with overlapping offerings in their core market segments like Avise HLA or A-CPRA (e,g, CareDx (#CDXC), Organovo (#ONVO), Immucor ((#BLUD), etc) **

- Exagen’s key differentiator is the unique approach used by Avisor  C-PPRA in   detecting auto-antibodies, a crucial factor  it aims  leverage for growth.   

Potential Challenges: ** * * Regulatory: Exagen's test approvals, particularly Avisor PDL1 (IHC-CPS), are crucial for market.

• • Competition : Keeping pace with innovations and commercial efforts of larger players is critical * Commercialization: Effectively marketing their tests, especially with new offerings, and building brand recognition is essential for success

Potential Opportunities :

• New products : Avise Skin and the Kidney Monitoring platform. * Market expansion : Geographically and into new diagnostic segments . * Partnerships : Strategic collaborations to broaden access and reach

• Recent Acquisitions:

  1. Acellular Pharmaceuticals Inc.: Acquired for approximately $4M cash and 5M common stocks on March 8, 2020.

2. C-PPRA acquired from Immunodiagnostic Systems in January

• AI -Based fundamental Rating * 5 - Moderate:
  • Exagen has promising products & growth trajectory, but profitability remains an area to monitor, hence, moderate overall AI - based fundamental rating . *

Sources

• Exagen Inc. Investor Page * 10Q - Exagen Inc (Exagen.Nasdaq)

• • • STATISTA, Businesswire   *  Yahoo finance, Bloomberg
      

Important disclaimer: This is just a general informational overview, not financial, legal or professional investment advice. Do not make investment decisions based only on this report. Always do your own research and seek advice from financial professionals before making any decisions.