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Hansa Biopharma AB (SE:HNSA)
:HNSA

Hansa Biopharma AB (HNSA) AI Stock Analysis

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SE:HNSA

Hansa Biopharma AB

(HNSA)

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Neutral 41 (OpenAI - 4o)
Rating:41Neutral
Price Target:
kr31.00
▲(10.95% Upside)
Hansa Biopharma AB's overall stock score reflects significant financial challenges, including negative equity and cash flow issues, which weigh heavily on the score. Technical analysis provides mixed signals, with some positive momentum but also potential overbought conditions. The valuation is weak due to a negative P/E ratio, indicating ongoing profitability issues. Despite positive developments from the earnings call, such as a successful Phase 3 trial and a strong cash position, these are not enough to offset the financial and valuation concerns.
Positive Factors
Successful Phase 3 Trial
The successful Phase 3 trial demonstrates the potential of Hansa's lead product, imlifidase, in addressing unmet medical needs, paving the way for regulatory approval and future revenue growth.
U.S. Market Opportunity
The U.S. market offers a substantial growth opportunity for Hansa Biopharma, with a large patient base and potential product launch, enhancing long-term revenue prospects.
Strong Cash Position
A robust cash position provides Hansa Biopharma with financial flexibility to invest in R&D and support its strategic initiatives, ensuring sustainability and growth.
Negative Factors
Decline in Revenue
A significant decline in revenue indicates challenges in market penetration and sales execution, which could hinder financial performance and growth prospects.
Challenges in Key Markets
Operational challenges in Germany and Spain highlight regional market risks and regulatory hurdles that could impact sales and strategic expansion.
Increased Operating Loss
Rising operating losses reflect ongoing financial strain, limiting the company's ability to invest in growth initiatives and potentially affecting long-term viability.

Hansa Biopharma AB (HNSA) vs. iShares MSCI Sweden ETF (EWD)

Hansa Biopharma AB Business Overview & Revenue Model

Company DescriptionHansa Biopharma AB (publ), a biopharmaceutical company, develops immunomodulatory treatments for enabling transplants and rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy, and cancer using its proprietary enzyme technology platform. The company's lead drug candidate is Imlifidase, an antibody cleaving enzyme therapy that is in phase 3 clinical trial for use in sensitized kidney transplantations patients, as well as for anti-GBM antibody disease; and phase 2 clinical trial for antibody-mediated kidney transplant rejection and Guillain Barré syndrome. It is also developing Novel immunoglobulin cleaving enzymes for Repeat dosing (NiceR) for the treatment of autoimmune diseases, transplantation, and oncology; and Enzyme based antibody Enhancement (EnzE), which is cancer immunotherapy. The company has a preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies. Hansa Biopharma AB (publ) was incorporated in 2007 and is headquartered in Lund, Sweden.
How the Company Makes MoneyHansa Biopharma generates revenue primarily through the commercialization of its therapeutics, particularly imlifidase, which is being marketed for use in kidney transplantation and other indications. The company may also earn revenue through strategic partnerships and collaborations with larger pharmaceutical firms, which can involve upfront payments, milestone payments based on developmental progress, and royalties from product sales. Additionally, Hansa Biopharma is likely to engage in research agreements and licensing deals that can provide supplementary income as it expands its pipeline of enzyme-based therapies.

Hansa Biopharma AB Earnings Call Summary

Earnings Call Date:Oct 30, 2025
(Q3-2025)
|
% Change Since: |
Next Earnings Date:Feb 05, 2026
Earnings Call Sentiment Neutral
While the company has achieved significant progress with the successful Phase 3 trial and sees a large opportunity in the U.S. market, it faces challenges in Europe with declining revenues and specific market issues in Germany and Spain. Financial metrics also indicate an increased operating loss, although the cash position and gross margin have improved.
Q3-2025 Updates
Positive Updates
Successful Phase 3 ConfIdeS Trial Outcome
The Phase 3 ConfIdeS trial showed a strong p-value of 0.0001, indicating significant unmet medical need for highly sensitized patients. This supports the forthcoming BLA filing in the U.S.
U.S. Market Opportunity
The U.S. market represents a significant growth opportunity with 15,000 highly sensitized patients on the transplant waitlist and robust clinical data supporting a potential launch in the second half of 2026, subject to FDA approval.
Strong Cash Position
The company reported cash and cash equivalents of SEK 252.1 million, increasing to SEK 888 million including net proceeds from a recent capital raise.
Improved Gross Margin
The company's gross margin for the nine months ended September 30, 2025, was 60%, up from 50% for the same period in 2024.
Negative Updates
Decline in Q3 Revenue
Total revenue for Q3 2025 was SEK 31 million, marking a 37% decrease from the same period a year ago. Product sales were 24% below Q3 2024.
Challenges in Germany and Spain
No sales in Germany due to the pause in the prioritized transplant program, and sales in Spain were impacted by the lack of transplant protocols and regional reimbursement issues.
Increased Operating Loss
The Q3 2025 operating loss was approximately SEK 147.6 million, which was 20.8% unfavorable compared to Q3 2024.
Company Guidance
During Hansa Biopharma's Q3 2025 results conference call, the company reported significant developments, including the successful outcome of their Phase 3 ConfIdeS trial with a strong p-value of 0.0001, emphasizing its potential in meeting unmet medical needs for highly sensitized patients. The company also highlighted restructuring efforts and financial milestones, such as a 25% increase in year-to-date product sales to SEK 143.6 million, despite a 37% decrease in total revenue for the quarter to SEK 31 million. SG&A expenses rose by SEK 16.6 million compared to the previous year, while R&D expenses were reduced by 11.8%. The company's operating loss for the quarter was SEK 147.6 million. Hansa Biopharma remains optimistic about the U.S. market, targeting a BLA filing by the end of the year and a potential launch in the second half of 2026, with expectations of a strengthened cash position following two equity raises and a pro forma cash and cash equivalents total of SEK 888 million.

Hansa Biopharma AB Financial Statement Overview

Summary
Hansa Biopharma AB faces significant financial challenges, with consistent net losses, negative equity, and cash flow difficulties. Despite some revenue growth, high leverage and ongoing operational inefficiencies pose risks to financial stability.
Income Statement
37
Negative
Hansa Biopharma AB's income statement reflects substantial challenges, with consistent net losses and negative EBIT and EBITDA margins. The gross profit margin is relatively higher, indicating some ability to cover variable costs, but the net profit margin remains negative. Revenue has shown some growth over the years, yet profitability remains elusive.
Balance Sheet
22
Negative
The balance sheet indicates significant financial stress with negative stockholders' equity, suggesting more liabilities than assets. The debt-to-equity ratio is not calculable due to negative equity, while high total debt levels pose a risk. The equity ratio is negative, further highlighting financial instability.
Cash Flow
30
Negative
Cash flow analysis reveals negative operating cash flows and free cash flows, indicating challenges in generating cash from operations. Although financing activities have provided cash inflows, the free cash flow to net income ratio remains unfavorable, reflecting ongoing operational cash deficits.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue178.61M171.32M134.09M154.53M33.88M6.10M
Gross Profit106.22M87.76M70.95M116.05M18.45M5.10M
EBITDA-479.13M-642.07M-714.55M-554.26M-538.83M-413.08M
Net Income-640.63M-807.24M-831.72M-611.13M-548.28M-420.85M
Balance Sheet
Total Assets741.11M800.64M1.02B1.69B1.01B1.43B
Cash, Cash Equivalents and Short-Term Investments252.07M405.28M732.06M1.50B888.96M1.38B
Total Debt923.89M1.08B866.77M791.09M35.38M5.04M
Total Liabilities1.30B1.39B1.19B1.08B255.24M192.37M
Stockholders Equity-560.74M-589.83M-167.88M602.91M757.57M1.24B
Cash Flow
Free Cash Flow-560.72M-675.00M-755.94M-506.06M-483.57M-290.57M
Operating Cash Flow-560.09M-674.88M-755.65M-502.73M-481.17M-290.27M
Investing Cash Flow-628.00K-116.00K-284.00K229.31M-2.40M182.53M
Financing Cash Flow259.79M346.81M-7.54M1.12B-4.86M1.07B

Hansa Biopharma AB Technical Analysis

Technical Analysis Sentiment
Negative
Last Price27.94
Price Trends
50DMA
31.93
Negative
100DMA
32.25
Negative
200DMA
28.41
Negative
Market Momentum
MACD
0.64
Positive
RSI
36.13
Neutral
STOCH
41.82
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For SE:HNSA, the sentiment is Negative. The current price of 27.94 is below the 20-day moving average (MA) of 32.66, below the 50-day MA of 31.93, and below the 200-day MA of 28.41, indicating a bearish trend. The MACD of 0.64 indicates Positive momentum. The RSI at 36.13 is Neutral, neither overbought nor oversold. The STOCH value of 41.82 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for SE:HNSA.

Hansa Biopharma AB Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
76
Outperform
kr3.03B4.60167.77%2687.51%
51
Neutral
$7.86B-0.30-43.30%2.27%22.53%-2.21%
47
Neutral
kr1.84B-5.65-36.52%533.73%20.92%
47
Neutral
kr1.23B-5.06-35.03%25.14%
45
Neutral
kr2.82B-5.34-71.87%-91.85%-6.65%
41
Neutral
kr3.40B-3.14-5.69%21.58%
31
Underperform
kr1.10B8.0781.19%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
SE:HNSA
Hansa Biopharma AB
27.94
-8.70
-23.74%
SE:BINV
BioInvent International AB
27.80
-10.75
-27.89%
SE:SANION
Saniona AB
21.15
13.08
162.08%
SE:VICO
Vicore Pharma Holding AB
9.82
2.17
28.37%
SE:XSPRAY
Xspray Pharma AB
29.75
-11.45
-27.80%
SE:CANTA
Cantargia AB
4.09
2.26
122.89%

Hansa Biopharma AB Corporate Events

Hansa Biopharma to Present at Major Healthcare Conferences
Nov 13, 2025

Hansa Biopharma announced its CEO, Renée Aguiar-Lucander, will participate in key discussions at the Jefferies Global Healthcare Conference in London and the DNB Carnegie’s 16th Annual Nordic Healthcare Conference in Oslo. These engagements are significant for Hansa Biopharma as they provide a platform to showcase its innovative treatments and strengthen its industry positioning, potentially impacting stakeholder relations and market perception.

Hansa Biopharma Hosts Virtual Event on Imlifidase Phase 3 Results
Nov 12, 2025

Hansa Biopharma AB announced a virtual event featuring transplant experts to discuss the Phase 3 results of their imlifidase treatment for highly sensitized kidney transplant patients. The event aims to provide insights into the clinical relevance of these results and their potential impact on the standard of care for transplant patients, highlighting the company’s commitment to addressing the needs of this challenging patient group.

Hansa Biopharma Engages in Key Industry Conferences
Nov 5, 2025

Hansa Biopharma announced that its CEO, Renée Aguiar-Lucander, and CFO, Evan Ballantyne, will attend the 2025 Truist Securities Biopharma Symposium in New York. Aguiar-Lucander will also present at the Stifel 2025 Healthcare Conference and the SEB Healthcare Seminar 2025. These appearances highlight Hansa’s active engagement with the investment community and underscore its strategic focus on expanding its presence in the biopharmaceutical industry.

Hansa Biopharma Expands Share Capital with New Share Issue
Oct 31, 2025

Hansa Biopharma has increased its registered share capital and the number of shares and votes by issuing 17,000,000 new ordinary shares, bringing the total to 101,763,222 shares and votes. This move reflects the company’s strategic efforts to strengthen its financial position and support its ongoing research and development initiatives in the biopharmaceutical industry.

Hansa Biopharma’s Imlifidase Achieves Key Milestone in U.S. Phase 3 Trial
Oct 30, 2025

Hansa Biopharma announced that its drug imlifidase successfully met the primary endpoint in a pivotal U.S. Phase 3 trial for kidney transplantation, showing significant improvement in kidney function compared to the control group. The company plans to file a Biologic License Application with the FDA by the end of 2025, potentially enhancing its market position in the U.S. Additionally, Hansa reported a 25.4% increase in year-to-date product sales of IDEFIRIX, reflecting strong market performance. The company also completed a directed share issue raising approximately 671.5 MSEK to support its operational expansion and regulatory submissions.

Hansa Biopharma Hosts Event on Imlifidase Phase 3 Results
Oct 29, 2025

Hansa Biopharma AB announced a virtual event featuring renowned transplant surgeons to discuss the clinical relevance of the US Phase 3 ConfIdeS study results on Imlifidase, a treatment for highly sensitized kidney transplant patients. This event underscores Hansa’s commitment to advancing transplantation medicine and highlights the potential impact of Imlifidase on improving transplant accessibility and outcomes for patients with limited donor options.

Hansa Biopharma’s Imlifidase Enables Breakthrough in Gene Therapy for Crigler-Najjar Syndrome
Oct 10, 2025

Hansa Biopharma and Genethon have announced successful results from a clinical trial using imlifidase as a pretreatment for gene therapy in a patient with Crigler-Najjar syndrome who is immune to AAV vectors. This breakthrough could potentially expand gene therapy options for patients previously ineligible due to immunity, marking a significant advancement in the treatment of rare genetic diseases.

Hansa Biopharma to Discuss Q3 2025 Results in Upcoming Conference Call
Oct 8, 2025

Hansa Biopharma announced it will host a conference call to discuss its Q3 2025 interim results on October 30, 2025. The call, led by key executives, will cover the company’s financial performance and provide updates on its business and pipeline, reflecting its ongoing commitment to addressing serious medical needs in its field.

Hansa Biopharma CEO to Participate in Key Industry Conferences
Oct 7, 2025

Hansa Biopharma announced that its CEO, Renée Aguiar-Lucander, will participate in two significant industry events: Optimum’s 17th Annual Healthcare Investor Conference and Nordic Life Science Days 2025. These engagements highlight Hansa’s active role in shaping industry discussions on exit strategies and future financing trends, potentially enhancing its visibility and influence in the biopharmaceutical sector.

Hansa Biopharma Announces Directed Share Issue for Nasdaq Stockholm Trading
Oct 2, 2025

Hansa Biopharma announced a directed share issue of 17 million ordinary shares to facilitate their trading on Nasdaq Stockholm, with trading expected to commence around October 6, 2025. This move is part of Hansa’s strategic efforts to enhance its market presence and operational capabilities, potentially impacting its industry positioning and stakeholder interests.

Hansa Biopharma Raises USD 71 Million to Boost U.S. Market Efforts
Oct 1, 2025

Hansa Biopharma has successfully raised approximately USD 71 million through a directed share issue of 17 million shares, aimed at Swedish and international institutional investors. The proceeds will support the company’s strategic initiatives, including a potential Biologic License Application filing with the FDA for imlifidase, and enhancing its medical and commercial capabilities in the U.S. This capital raise is a strategic move to strengthen Hansa’s market position and prepare for the potential U.S. launch of imlifidase, reflecting strong investor confidence and expanding its shareholder base.

Hansa Biopharma Plans USD 60 Million Share Issue to Boost U.S. Market Efforts
Oct 1, 2025

Hansa Biopharma AB announced its intention to raise approximately USD 60 million through a directed share issue aimed at Swedish and international institutional investors. The funds will support the company’s strategic initiatives, including the potential filing of a Biologic License Application with the FDA and preparations for the commercial launch of imlifidase in the U.S. The decision for a directed share issue, as opposed to a rights issue, was made to ensure timely capital acquisition and to attract strategic biotechnology investors, reflecting the company’s proactive approach to strengthening its market position.

Hansa Biopharma’s Imlifidase Shows Promise in Gene Therapy for Crigler-Najjar Syndrome
Sep 26, 2025

Hansa Biopharma announced that Genethon will present preliminary data from a Phase 2 trial of imlifidase as a pre-treatment for gene therapy in patients with severe Crigler-Najjar syndrome at the ESGCT congress. The trial, which aims to address the barrier of anti-AAV antibodies in gene therapy, could significantly impact the treatment landscape for this ultra-rare disease, potentially enabling more patients to benefit from gene therapies.

Hansa Biopharma Reports Positive Phase 3 Trial Results for Imlifidase in Kidney Transplantation
Sep 24, 2025

Hansa Biopharma announced successful results from its US Phase 3 ConfIdeS trial for imlifidase, showing significant improvement in kidney function in highly sensitized transplant patients. The positive outcomes, including superior kidney function and dialysis independence, position imlifidase as a potential transformative treatment in kidney transplantation, with plans for a Biologic License Application submission to the FDA by the end of 2025.

Hansa Biopharma to Present at Pareto Healthcare Conference
Sep 15, 2025

Hansa Biopharma announced that its CEO, Renée Aguiar-Lucander, will present at the 16th Annual Pareto Securities Healthcare Conference in Stockholm. The presentation and subsequent panel discussion will address current industry dynamics, including business deals, healthcare system changes, and investor sentiment, potentially impacting the company’s operations and positioning within the biopharmaceutical industry.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Nov 27, 2025