New Risk • 22h
New minor risk - Profit margin trend The company's profit margins are lower than last year and have reduced by more than 30%. Net profit margin: 19% Last year net profit margin: 59% This is considered a minor risk. A large drop in profit margin could indicate the company does not have strong competitive advantages or it is yet to establish itself and its core business. Even if it is a well established business, this may make it a much riskier investment than one that has a combination of proven competitive advantages and a stable or growing profit margin. This is currently the only risk that has been identified for the company. 속보 • May 20
FDA Pushes Leqembi Iqlik Decision to August 2026 Keeping BioArctic in Global Spotlight The FDA has extended its review of the supplemental Biologics License Application for Leqembi Iqlik, a once-weekly subcutaneous formulation for early Alzheimer's disease, pushing the PDUFA date to 24 August 2026 after requesting additional information classified as a major amendment.
Regulators have not raised concerns about the approvability of Leqembi Iqlik, while Leqembi is already authorized in more than 50 countries and Eisai and BioArctic are preparing for joint commercialization of the subcutaneous product in the Nordic region.
Eisai’s Leqembi sales in its 2025 fiscal year surpassed €500m, triggering a €20m milestone payment to BioArctic. Long-term and real-world data suggest patients stay on treatment for extended periods, with disease-slowing effects observed for up to four years, even as Sweden’s NT Council has denied reimbursement and other submissions progress in the EU, US and China.
The FDA review extension introduces a longer timeline for the new formulation, but the breadth of existing approvals and ongoing global submissions keep Leqembi central to BioArctic’s commercial story.
Investors may want to pay close attention to future regulatory and reimbursement decisions, since they directly affect the pace and scale of potential royalty streams and milestone payments to BioArctic. Major Estimate Revision • May 18
Consensus EPS estimates increase by 344% The consensus outlook for earnings per share (EPS) in fiscal year 2026 has improved. 2026 revenue forecast increased from kr1.20b to kr1.25b. EPS estimate increased from kr0.66 to kr2.93 per share. Net income forecast to shrink 75% next year vs 9.0% growth forecast for Biotechs industry in Sweden . Consensus price target of kr301 unchanged from last update. Share price was steady at kr324 over the past week. Reported Earnings • Apr 26
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: EPS: kr11.55 (up from kr2.00 loss in FY 2024). Revenue: kr2.00b (up kr1.74b from FY 2024). Net income: kr1.02b (up kr1.20b from FY 2024). Profit margin: 51% (up from net loss in FY 2024). The move to profitability was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 1.5%. Revenue is forecast to grow 5.3% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 69% per year but the company’s share price has only increased by 6% per year, which means it is significantly lagging earnings growth. 공시 • Mar 28
Bioarctic AB Announces Declining of Re-Election by Pär Gellerfors as Board Member BioArctic AB at the Annual General Meeting to be held on May 28, 2026 announced that Board member Pär Gellerfors has declined re-election. Major Estimate Revision • Feb 25
Consensus EPS estimates fall by 72%, revenue upgraded The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast increased from kr1.13b to kr1.23b. EPS estimate fell from kr2.32 to kr0.66 per share. Net income forecast to shrink 72% next year vs 11% growth forecast for Biotechs industry in Sweden . Consensus price target broadly unchanged at kr304. Share price fell 13% to kr318 over the past week. Reported Earnings • Feb 19
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: EPS: kr11.55 (up from kr2.00 loss in FY 2024). Revenue: kr2.00b (up kr1.74b from FY 2024). Net income: kr1.02b (up kr1.20b from FY 2024). Profit margin: 51% (up from net loss in FY 2024). The move to profitability was driven by higher revenue. Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 1.5%. Revenue is forecast to grow 2.4% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 69% per year but the company’s share price has only increased by 8% per year, which means it is significantly lagging earnings growth. 공시 • Feb 11
BioArctic AB (publ) to Report Q4, 2025 Results on Feb 18, 2026 BioArctic AB (publ) announced that they will report Q4, 2025 results at 8:00 AM, Central European Standard Time on Feb 18, 2026 공시 • Feb 10
Bioarctic AB (Publ) for Subcutaneous Formulation of Leqembi Designated for Priority Review in China BioArctic AB's (publ) partner Eisai announced that the Biologics License Application (BLA) for the treatment of early Alzheimer's disease with Leqembi (lecanemab), using a subcutaneous autoinjector (SC-AI), has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The BLA for the subcutaneous formulation was accepted for review by the NMPA in January 2026. The Priority Review and Approval Procedure has been implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened. If approved, the SC-AI of 500 mg (two 250 mg injections) could be used to administer a once-weekly dose at home from the initiation of treatment, as an alternative to the current IV administration every two weeks in a hospital setting. The potential approval of SC-AI would expand the option for patients and care partners to receive Leqembi treatment at home. Eisai estimates that in 2024 there were 17 million patients with Mild Cognitive Impairment (MCI) or mild disease due to Alzheimer's disease in China, a number that is expected to rise as the population ages. Leqembi was launched in China in June 2024 and is available to the private market. Furthermore, Leqembi has been included in the newly introduced "Commercial Insurance Innovative Drug List" which took effect in January 2026, under new Chinese government policies that support the development of and access to innovative medicines. Based on the Commercial Insurance Innovative Drug List, commercial insurance companies will develop insurance products covering Leqembi. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. In December 2025, Leqembi was included in the "Commercial Insurance Innovative Drug list", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, Eisai's supplemental Biologics License Application regarding a subcutaneous starting dose with Leqembi Iqlik was granted Priority Review by the US FDA with a May 24, 2026, PDUFA date. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2026, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington, Sweden. New Risk • Jan 13
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 68% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 13% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (68% increase in shares outstanding). Minor Risk Significant insider selling over the past 3 months (kr54m sold). Recent Insider Transactions • Dec 22
Co-Founder recently sold kr54m worth of stock On the 18th of December, Lars Lannfelt sold around 174k shares on-market at roughly kr310 per share. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was Lars' only on-market trade for the last 12 months. Recent Insider Transactions • Dec 07
VP & Head of CMC recently sold kr320k worth of stock On the 4th of December, Mikael Moge sold around 1k shares on-market at roughly kr320 per share. This transaction amounted to 8.8% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr2.2m more than they bought in the last 12 months. 공시 • Nov 19
BioArctic AB's (publ) Partner Eisai to Present the Latest Findings on Lecanemab (Leqembi) at the Clinical Trials on Alzheimer's Disease Conference BioArctic AB's (publ) partner Eisai will present the latest findings on lecanemab (Leqembi®?) at the Clinical Trials on Alzheimer's Disease (CTAD) conference, being held in San Diego December 1-4. Presentations will include data on long-term treatment and estimated time savings over 10 years, as well as safety and potential benefits of subcutaneous administration of lecanemab for initiation dosing. In addition, data on the effects of lecanemab on soluble amyloid-beta (Ab) protofibrils and insights from real-world clinical practice studies, including the US ALZ-NET registry, will also be presented. Key oral presentations: Continued treatment: On Tuesday, Dec. 2, at 5:05 PM PT and Wednesday, Dec. 3, at 2:40 PM PT, new analyses will be presented on benefits of continued therapy and estimated time savings over 10 year of lecanemab treatment based on Phase 3 clinical data (LB12, LB21). Subcutaneous initiation dosing: On Wednesday, Dec. 3, the late-breaking symposium, "Lecanemab Subcutaneous Formulation for Treatment Initiation in Early Alzheimer's Disease: Optimizing Patient Care with a Potential New Option" (3:10 - 3:50 PM PT), will explore potential benefits of subcutaneous lecanemab initiation dosing as well as pharmacokinetic and safety findings (LB Symposium 2). Real-world experience: A presentation on Thursday, Dec. 4, at 11:40 AM PT will share findings from an interim analysis of a post-marketing observational study of lecanemab in Japan (OC30). Mechanism-related: A presentation scheduled for Tuesday, Dec. 2, in Dec. 2, at 1:40 PM PT, will review the effects of le canemab treatment on soluble Ab protofibrils in the Clarity AD clinical trial (OC5). Key lecanemab poster presentation: Real-world experience: During the poster session on Dec. 1, at 3:00 PM PT and Tuesday, Dec. 2, At 5:30 PM PT, Poster 055 presents an overview of baseline characteristics and preliminary safety findings from a study of lecanemab In Alzheimer's disease (AD) using the ALZ-NET registry. Additional lecanemab poster presentations: Dec. 1 (Mon.) - Dec. 2 (Tues.) Real-world experience: A presented on Dec. 1 (Mon.)-Tues.) Characterizing Enrollment patterns in a Preclinical Alzheimer's Disease Trial (P006); Dec. 1 (Mon.) -- Dec. 2 (Tues) Stability and Improvement in Early Alzheimer's Disease with Lecanemab: Sub-analysis from a United States Multicenter, Retrospective Real-World Study (P049); Dec. 1 (Mon.). - Dec. 2 (Tue.) Long-Term Benefit of Lecanemab in Patients with Low Baseline Amyloid: Estimation of Time Saved (P052); Dec. 1 (Mon.), Dec. 2 (Tues.). Patient, Care Partner, and Health Care Professional Acceptability of the Autoinjector for the Subcutaneous Delivery of Lecanemab In the US (P053). Dec. 1 (Mon.). Reported Earnings • Nov 14
Third quarter 2025 earnings released: kr0.98 loss per share (vs kr0.22 loss in 3Q 2024) Third quarter 2025 results: kr0.98 loss per share (further deteriorated from kr0.22 loss in 3Q 2024). Revenue: kr133.3m (up 74% from 3Q 2024). Net loss: kr86.9m (loss widened 343% from 3Q 2024). Revenue is expected to decline by 2.9% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Sweden are expected to grow by 11%. Over the last 3 years on average, earnings per share has increased by 66% per year but the company’s share price has remained flat, which means it is significantly lagging earnings. 공시 • Oct 20
BioArctic AB (publ), Annual General Meeting, May 28, 2026 BioArctic AB (publ), Annual General Meeting, May 28, 2026, at 16:30 W. Europe Standard Time. Location: stockholm Sweden 공시 • Oct 14
BioArctic AB (publ) Announces First Patient Treated with Leqembi (Lecanemab) in the Nordics BioArctic AB (publ) announced that Leqembi has now been made available at a private clinic in Finland and that the first patient has started treatment. BioArctic copromotes Leqembi with its partner Eisai in the Nordic countries, and this marks an important strategic step for BioArctic on the company's journey towards building Sweden's next major pharmaceutical company. Leqembi received the European Commission (EC) approval in April 2025 as the first therapy that targets an underlying cause of Alzheimer's disease (AD). It is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E e4 (ApoE e4[1]) non-carriers or heterozygotes with confirmed amyloid pathology. Following the EC approval, BioArctic and Eisai have been collaborating with the Nordic healthcare authorities to implement the mandatory authorisation requirements. The required controlled access program is now in place in Finland, enabling private clinics such as Terveystalo Ruoholahti, where the first patient was treated, to help patients with early Alzheimer´s disease. In the meantime, Leqembi is under assessment for inclusion in the publicly funded health care system. Alzheimer's disease is a progressive, relentless disease with Aß and tau as hallmarks. It progresses in stages that increase in severity over time, and each stage of the disease presents different challenges for those living with the disease and their care partners. The data show that amyloid-beta protofibrils and tau tangles play roles in the neurodegeneration process,[4],[5],[6] and Leqembi is the only approved treatment that fights Alzheimer's disease in two ways - targeting both protofibrils[i] and amyloid plaque, which can impact tau downstream. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region. 공시 • Sep 24
BioArctic AB (publ) Announces the TGA Approval for the Treatment of Early Alzheimer's Disease in Australia BioArctic AB's (publ) announced that the Therapeutic Goods Administration (TGA) of Australia has approved lecanemab (Leqembi) for the treatment of adult patients with mild cognitive impairment or mild dementia due to Alzheimer's disease (early Alzheimer's disease) that are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes, with confirmed amyloid pathology. In response to February 2025 the TGA decision not to approve lecanemab for the treatment for people with early AD, in March 2025, Eisai requested a review by the Administrative Review Tribunal. As a result of the discussions during this process, the TGA and Eisai reached an agreement that led to the approval of Leqembi. Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lann felt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of Leqembi for Alzheimer's disease. BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai and the two companies are preparing for a joint commercialization in the region. Major Estimate Revision • Sep 08
Consensus EPS estimates fall by 13%, revenue upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from kr1.94b to kr2.00b. EPS estimate fell from kr13.71 to kr11.90 per share. Net income forecast to shrink 36% next year vs 19% growth forecast for Biotechs industry in Sweden . Consensus price target up from kr286 to kr293. Share price fell 6.1% to kr290 over the past week. Recent Insider Transactions • Sep 03
VP and Head of IR & Communication recently sold kr1.2m worth of stock On the 28th of August, Oskar Bosson sold around 4k shares on-market at roughly kr299 per share. This transaction amounted to 38% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr1.7m more than they bought in the last 12 months. Price Target Changed • Sep 02
Price target increased by 8.8% to kr311 Up from kr286, the current price target is an average from 4 analysts. New target price is approximately in line with last closing price of kr317. Stock is up 92% over the past year. The company is forecast to post earnings per share of kr12.81 next year compared to a net loss per share of kr2.00 last year. Reported Earnings • Aug 31
Second quarter 2025 earnings released: EPS: kr1.09 (vs kr0.78 loss in 2Q 2024) Second quarter 2025 results: EPS: kr1.09 (up from kr0.78 loss in 2Q 2024). Revenue: kr392.1m (up kr342.3m from 2Q 2024). Net income: kr96.6m (up kr165.0m from 2Q 2024). Profit margin: 25% (up from net loss in 2Q 2024). The move to profitability was driven by higher revenue. Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 60% per year but the company’s share price has only increased by 47% per year, which means it is significantly lagging earnings growth. Valuation Update With 7 Day Price Move • Aug 27
Investor sentiment improves as stock rises 18% After last week's 18% share price gain to kr276, the stock trades at a forward P/E ratio of 26x. Average trailing P/E is 31x in the Biotechs industry in Sweden. Total returns to shareholders of 190% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at kr496 per share. Valuation Update With 7 Day Price Move • Jul 23
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to kr220, the stock trades at a forward P/E ratio of 22x. Average trailing P/E is 28x in the Biotechs industry in Sweden. Total returns to shareholders of 95% over the past three years. 공시 • Jun 13
BioArctic to Initiate Next Cohorts in Exidavnemab Phase 2a Study After Positive Safety Review BioArctic AB (publ) announced that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. The EXIST study evaluates exidavnemab, a drug candidate being developed as a treatment for Parkinson's disease and Multiple System Atrophy (MSA). The first cohort in the ongoing clinical Phase 2a study EXist evaluated a lower dose of exidavnemab compared to placebo in patients with Parkinson's disease. An interim safety review showed that exidavnemab was safe and well tolerated. The positive outcome will result in the initiation of two further cohorts, to evaluate a higher dose of exidavnemib in comparison with placebo in patients with Parkinson's Disease as well as MSA. The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blinded, placebo-controlled study to evaluate the safety and tolerability of exidavnemab and its pharmacokinetic profile. In addition, a broad range of biomarkers will be evaluated in plasma, cerebrospinal fluid (CSF), and using digital measurements. Exidavnemab is being developed as a novel disease-modifying treatment for synucleinopathies such as Parkinson's disease and MSA. Exidavnemab are a monoclonal antibody (mAb) that selectively targets pathological alpha-synuclein aggregates, while sparing the physiological forms. Aggregated alpha-synuclein damages nerve cells, and by selectively binding and removing these aggregates, exidavnemab is intended to preserve nerve cell function and slow the disease. There is a large unmet medical need for slowing disease progression in diseases such as Parkinson's disease andMSA. Exidavnemib has recently been granted orphan drug designation (ODD) in the US and a positive opinion regarding orphan medicinal product designation (OD) in the EU for the treatment of MSA. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval. Price Target Changed • Jun 04
Price target decreased by 8.0% to kr289 Down from kr314, the current price target is an average from 5 analysts. New target price is 45% above last closing price of kr200. Stock is down 17% over the past year. The company is forecast to post earnings per share of kr11.92 next year compared to a net loss per share of kr2.00 last year. New Risk • May 21
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 6.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. Price Target Changed • May 07
Price target decreased by 9.6% to kr302 Down from kr335, the current price target is an average from 5 analysts. New target price is 66% above last closing price of kr182. Stock is down 6.7% over the past year. The company is forecast to post earnings per share of kr10.78 next year compared to a net loss per share of kr2.00 last year. Reported Earnings • Apr 25
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: kr2.00 loss per share (down from kr2.60 profit in FY 2023). Revenue: kr257.4m (down 58% from FY 2023). Net loss: kr177.1m (down 177% from profit in FY 2023). Products in clinical trials Phase II: 1 Phase III: 1 Post-clinical trial products Approved (during full year): 2 Revenue exceeded analyst estimates by 1.9%. Earnings per share (EPS) also surpassed analyst estimates by 9.8%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has increased by 37% per year, which means it is well ahead of earnings. 공시 • Apr 08
BioArctic AB (publ) Presents Data on Exidavnemab and Lecanemab at 2025 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurolog Disorders BioArctic AB (publ) presented data on exidavnemab and lecanemab at the 2025 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD™?), held in Vienna, Austria, April 1-5. BioArctic's partner Eisai also presented new data including results from real-world use of lecanemab. At AD/PD, Dr Johanna Falting, Head of R&D at BioArctic, held an oral presentation on exidavnemab, the company's proprietary drug candidate aimed at treating Parkinson's disease and other alpha-synucleinopathies. In the Phase 1 studies, exidavnemab was generally well tolerated and demonstrated an elimination half-life of approximately 30 days. These properties make exidavnemab a suitable candidate for future studies of disease modification in alpha-synucleinopathyies. The design of the ongoing EXIST Phase 2a study in Parkinson's disease was presented. New data on lecanemab were also presented at the conference. Lecanemab is an anti-amyloid beta (Ab) monoclonal antibody that preferentially binds to toxic protofibrils (soluble Ab aggregates), in addition to targeting and reducing Ab plaques (insoluble Ab aggregates). In an oral presentation by Dr Michael Rosenbloom, University of Washington, USA, recent findings from real-world clinical evidence of lecanemab in the United States were presented. The utilization patterns showed that real-world use of le canemab conforms with the FDA approved prescribing recommendations, and patient adherence suggests that neither MRI monitoring nor possible adverse events significantly interfered with lecanemab dosing. In two other presentations, Dr Lutz Froelich, University of Heidelberg, Germany, presented the efficacy and safety outcomes of lecanemab in early AD apolipoprotein E e4 (ApoEe4) heterozygous carriers and non-carriers in the Phase 3 Clarity AD clinical study. The data presented were forming the basis for the regulatory approval in United Kingdom and the positive CHMP recommendation for EU approval, respectively. The data for the UK and EMA proposed indicated population confirmed that the effects of lecanemab were similar to the overall Clarity AD population with lower risk of ARIA events. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval. 공시 • Feb 21
Bioarctic's Global License Agreement with Bristol Myers Squibb for Pyroglutamate-Amyloid-Beta Antibody Program Effective After Antitrust Clearance and Closing BioArctic AB (publ) announced that BioArctic and its partner Bristol Myers Squibb (NYSE: BMY) have received clearance from the U.S. Federal Trade Commission (FTC) for BioArctic to out-license its PyroGlutamate-amyloid-beta (PyroGlu-Aß) antibody program to Bristol Myers Squibb. Closing of the agreement has been completed and BioArctic will receive an upfront payment of USD 100 million. On December 19, 2024, BioArctic announced that BioArctic had entered into a global license agreement with Bristol Myers Squibb under which Bristol Myers Squibb will become solely responsible for the development and any subsequent commercialization of BAN1503 and BAN2803 and related products worldwide. The agreement was subject to filing and clearance under U.S. Antitrust legislation (the Hart-Scott-Rodino Antitrust Improvements Act of 1976), a condition which has been fulfilled, and the transaction has now closed. The finalization of the agreement triggers an upfront payment of USD 100 million to BioArctic. The license agreement further includes up to USD 1.25 billion in development, regulatory and commercial milestones, as well as tiered low double-digit royalties on global product sales. BioArctic will retain an option to co-commercialize the products in the Nordic region. BioArctic's PyroGlu-Aß antibody program consists of novel antibodies targeting a specific truncated, pyroglutamate modified form of amyloid-beta. Monomers of PyroGlu-Aß are highly prone to aggregate, leading to the formation of harmful aggregates which cause debilitating cognitive and other symptoms in Alzheimer's disease. The agreement includes both the BAN1503 and BAN2803 antibodies. BAN2803 includes BioArctic'sBrainTransporter™ technology. Recent Insider Transactions Derivative • Feb 19
Insider exercised options to buy kr5.9m worth of stock. On the 13th of February, Johanna Fälting exercised 40.00k options at around kr83.60, then sold 15.00k of them at kr221 each and kept the remainder. Since June 2024, Johanna has owned 44.86k shares directly. Company insiders have collectively sold kr265k more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • Feb 14
Full year 2024 earnings: EPS and revenues exceed analyst expectations Full year 2024 results: kr2.00 loss per share (down from kr2.60 profit in FY 2023). Revenue: kr257.4m (down 58% from FY 2023). Net loss: kr177.1m (down 177% from profit in FY 2023). Revenue exceeded analyst estimates by 1.9%. Earnings per share (EPS) also surpassed analyst estimates by 9.8%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has fallen by 8% per year but the company’s share price has increased by 29% per year, which means it is well ahead of earnings. Recent Insider Transactions • Dec 26
VP and Head of IR & Communication recently sold kr776k worth of stock On the 19th of December, Oskar Bosson sold around 3k shares on-market at roughly kr224 per share. This transaction amounted to 24% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr1.1m more than they bought in the last 12 months. New Risk • Dec 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 13% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. This is currently the only risk that has been identified for the company. 공시 • Dec 05
BioArctic AB (publ) Announces Dosing of First Patient in EXIST Phase 2a Study in Parkinson's Disease BioArctic AB (publ) announced that the first patient has been dosed with exidavnemab in the EXIST Phase 2a study, in Parkinson's disease patients. Exidavnemab is a monoclonal antibody designed to target aggregated forms of the protein a-synuclein, believed to play a role in the disease progression in different neurological disorders including Parkinson's disease. The Phase 2a study EXIST (EXIdavnemab Synucleinopathy Trial), is a randomized, double-blind, placebo-controlled study in Parkinson's disease patients to evaluate the safety and tolerability of exidavnemab. The study is conducted in Europe and at least 24 patients will be recruited in, divided into two cohorts of 12 (Cohort 1 and Cohort 2). Participants in Cohort 1 will receive either a lower dose of exidavnemab or placebo and participants in Cohort 2 will receive either a higher dose of exidavnEMab or placebo. In addition to the primary endpoints, a broad range of biomarkers will be evaluated, in plasma, cerebrospinal fluid (CSF) and using digital measurements. Recently, the results of two separate Phase 1 studies of exidavnemab, conducted in collaboration with AbbVie, were published in The Journal of Clinical Pharmacology. The results showed that exidavnemab is generally well-tolerated, with an excellent half-life of approximately 30 days. These data together with the highinity and selectivity toward the pathological aggregated forms of a-synuclein, key to maintaining a high target binding in the brain, laid the foundation for the Phase 2a study. Price Target Changed • Nov 20
Price target increased by 9.8% to kr321 Up from kr292, the current price target is an average from 5 analysts. New target price is 80% above last closing price of kr179. Stock is down 24% over the past year. The company is forecast to post a net loss per share of kr2.69 compared to earnings per share of kr2.60 last year. Reported Earnings • Nov 15
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2024 results: kr0.22 loss per share (down from kr1.42 profit in 3Q 2023). Revenue: kr76.6m (down 63% from 3Q 2023). Net loss: kr19.6m (down 116% from profit in 3Q 2023). Revenue missed analyst estimates by 1.5%. Earnings per share (EPS) exceeded analyst estimates by 56%. Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 19% per year whereas the company’s share price has increased by 14% per year. 공시 • Nov 15
Eisai Co., Ltd. and BioAge Labs, Inc. Announce CHMP Issues Positive Recommendation for Approval of Lecanemab in the EU BioArctic AB (publ) announced that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai's marketing authorization application (MAA) for lecanemab as treatment of Alzheimer's disease. The recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers. The CHMP recommendation for the European Commission to approve lecanemab follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A decision from the European Commission is expected within 67 days. The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) or are non-carriers of the Apolipoprotein E e4 (ApoE e4) gene. Lecanemab is already approved in the US, Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, and the Great Britain. Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the rights to commercialize lecanemab in the Nordic region. Currently, BioArctic and Eisai are preparing for joint commercialization in these countries, pending approval from the European Commission. 공시 • Oct 13
BioArctic AB (publ) Presents Nomination Committee Pursuant to the instruction regarding the appointment of the Nomination Committee BioArctic AB’s (publ) shall have a Nomination Committee comprising one representative for each of the three principal shareholders in terms of votes, based on the information received from Euroclear Sweden AB on the last banking day in September 2024, as well as the Chairman of the Board (convener). September 30, 2024, the three largest shareholders were Demban AB, Ackelsta AB and The Fourth Swedish National Fund (Fjärde AP-fonden). The three owners who have agreed to be part of the Nomination Committee, Demban AB, Ackelsta AB and Fjärde AP-fonden, represent approx. 61% of the shares and approx. 84% of the votes in the company. The nomination committee comprises the following members: Margareta Öhrvall, appointed by Demban AB, Claes Andersson, appointed by Ackelsta AB, Jannis Kitsakis, chairperson of the Nomination Committee appointed by Fjärde AP-fonden. The Nomination Committee shall prepare proposals for the 2025 Annual General Meeting regarding the Chairman of the Meeting, number of Board members, fees to be paid to the Chairman of the Board and Board members, election of Board members and Board Chairman, remuneration to the auditor and election of auditor and, if necessary, proposal for changes in the instruction to the Nomination Committee. 공시 • Oct 12
BioArctic AB (publ), Annual General Meeting, May 22, 2025 BioArctic AB (publ), Annual General Meeting, May 22, 2025, at 16:30 W. Europe Standard Time. Location: stockholm Sweden Recent Insider Transactions Derivative • Sep 16
Vice President of Human Resources exercised options and sold kr454k worth of stock On the 12th of September, Gunilla Andersson exercised 5k options at a strike price of around kr83.10 and sold these shares for an average price of kr174 per share. This trade did not impact their existing holding. As of today, Gunilla currently holds no shares directly. Company insiders have collectively sold kr68k more than they bought, via options and on-market transactions in the last 12 months. Price Target Changed • Aug 30
Price target decreased by 9.3% to kr291 Down from kr320, the current price target is an average from 5 analysts. New target price is 75% above last closing price of kr167. Stock is down 47% over the past year. The company is forecast to post a net loss per share of kr1.13 compared to earnings per share of kr2.60 last year. Reported Earnings • Aug 30
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second quarter 2024 results: kr0.77 loss per share (improved from kr1.16 loss in 2Q 2023). Revenue: kr50.4m (up kr47.7m from 2Q 2023). Net loss: kr68.4m (loss narrowed 33% from 2Q 2023). Revenue exceeded analyst estimates by 2.6%. Earnings per share (EPS) also surpassed analyst estimates by 14%. Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 55% per year but the company’s share price has only increased by 5% per year, which means it is significantly lagging earnings growth. 공시 • Aug 27
BioArctic AB (publ) Announces Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology BioArctic AB (publ) announced that the results from two phase-1 studies with exidavnemab have been published in The Journal of Clinical Pharmacology. Exidavnemab is a drug candidate under development aimed at treating diseases such as Parkinson's disease. It is a monoclonal antibody designed to target aggregated forms of the protein -synuclein, while sparing the physiological form of the protein. In two separate phase 1 clinical studies conducted in collaboration with AbbVie, exidavnemab was tested on healthy volunteers to assess the safety, tolerability and pharmacokinetics of the candidate drug. The studies included 98 participants from different ethnic backgrounds, of which 85 received exidavnemab, either as an intravenous dose ranging from 100 to 6000 mg or a subcutaneous dose of 300 mg. The results showed that exidavnemab was generally well-tolerated. with an excellent half-life of approximately 30 days. This together with the high affinity and selectivity toward the pathological aggregated forms of -synuclein is key to maintain a high target binding in the brain. Price Target Changed • Jul 30
Price target decreased by 8.6% to kr336 Down from kr368, the current price target is an average from 5 analysts. New target price is 114% above last closing price of kr157. Stock is down 47% over the past year. The company is forecast to post a net loss per share of kr0.22 compared to earnings per share of kr2.60 last year. New Risk • Jul 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Swedish stocks, typically moving 12% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. This is currently the only risk that has been identified for the company. Board Change • Jun 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Director Lotta Ljungqvist was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Recent Insider Transactions • May 27
Insider recently sold kr710k worth of stock On the 24th of May, Johanna Fälting sold around 3k shares on-market at roughly kr237 per share. This transaction amounted to 6.3% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of kr3.4m more than they bought in the last 12 months. 공시 • May 25
BioArctic AB (publ) Approves Leqembi [®] for the Treatment of Alzheimer's Disease in South Korea BioArctic AB (publ) announced that the Ministry of Food and Drug Safety (MFDS) in South Korea published that Leqembi® (lecanemab) has been approved for treatment in patients with mild cognitive impairment due to Alzheimer's disease (AD) and mild AD (early AD). Reported Earnings • May 19
First quarter 2024 earnings: Revenues exceed analyst expectations First quarter 2024 results: Revenue: kr29.6m (down 93% from 1Q 2023). Net loss: kr57.6m (down 120% from profit in 1Q 2023). Revenue exceeded analyst estimates by 63%. Revenue is forecast to grow 48% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 112% per year but the company’s share price has only increased by 39% per year, which means it is significantly lagging earnings growth. Reported Earnings • Apr 21
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: EPS: kr2.60 (up from kr0.13 loss in FY 2022). Revenue: kr616.0m (up 169% from FY 2022). Net income: kr229.2m (up kr240.4m from FY 2022). Profit margin: 37% (up from net loss in FY 2022). The move to profitability was driven by higher revenue. Products in clinical trials Phase I: 2 Phase III: 1 Post-clinical trial products Pre-registration: 1 Approved (during full year): 1 Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) also surpassed analyst estimates by 24%. Revenue is forecast to grow 38% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 28% per year, which means it is significantly lagging earnings growth. 공시 • Mar 14
BioArctic AB (publ) and its Partner Eisai Present New Data on Lecanemab at 2024 International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders BioArctic AB (publ) and its partner Eisai presented new data on lecanemab (brand name: Leqembi) at the 2024 International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders (AD/PD), held in Lisbon, Portugal and virtually, March 5-9. BioArctic's founder, Professor Lars Lannfelt, presented data on the binding properties of the anti-amyloid-beta (Aß) antibody lecanemab and other anti Aß antibodies. Lecanemab was designed to preferentially bind soluble (protofibrils), as well as insoluble Aß aggregates (fibrils), to reduce both Aß protofibrils and Aß plaques in the brain. The difference in binding to CAA was presented, with lecanemab having lower binding to CAA than most other antibodies. This could explain the difference in the adverse event ARIA seen between different antibodies, with lecanemab showing relatively low incidence of ARIA. In another presentation Professor Christopher van Dyke presented extended efficacy results from the Phase 3 Clarity AD open label extension study of lecanemab in Alzheimer's disease up to 30 months, showing continued benefit with lecanemab treatment. Professor van Dyke also highlighted data from the tau sub-study of Clarity AD, which showed that all cohorts of the tau population benefitted from treatment with lecanemab. Data from the low tau population, representing earlier stages of the disease, indicated that intervening in early stages of disease may be particularly impactful in stabilizing the disease process. Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the anti Aß protofibril antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for commercialization in the region. Major Estimate Revision • Mar 10
Consensus EPS estimates increase by 112% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from kr494.3m to kr502.5m. EPS estimate increased from kr0.094 to kr0.199 per share. Net income forecast to shrink 93% next year vs 14% growth forecast for Biotechs industry in Sweden . Consensus price target broadly unchanged at kr366. Share price rose 6.4% to kr233 over the past week. Recent Insider Transactions Derivative • Feb 21
Vice President of Human Resources exercised options to buy kr1.2m worth of stock. On the 18th of February, Gunilla Andersson exercised options to buy 5k shares at a strike price of around kr83.60, costing a total of kr418k. This transaction amounted to less than 1% of their direct individual holding at the time of the trade. As of today, Gunilla currently holds no shares directly. Company insiders have collectively sold kr1.9m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • Feb 18
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: EPS: kr2.60 (up from kr0.13 loss in FY 2022). Revenue: kr620.1m (up 170% from FY 2022). Net income: kr229.2m (up kr240.4m from FY 2022). Profit margin: 37% (up from net loss in FY 2022). The move to profitability was driven by higher revenue. Products in clinical trials Phase I: 1 Phase III: 1 Post-clinical trial products Approved (during full year): 1 Revenue exceeded analyst estimates by 10%. Earnings per share (EPS) also surpassed analyst estimates by 24%. Revenue is forecast to grow 37% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Sweden. Over the last 3 years on average, earnings per share has increased by 101% per year but the company’s share price has only increased by 32% per year, which means it is significantly lagging earnings growth. Major Estimate Revision • Feb 16
Consensus revenue estimates fall by 15% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from kr595.9m to kr509.3m. EPS estimate fell from kr1.83 to kr0.352 per share. Net income forecast to shrink 73% next year vs 16% growth forecast for Biotechs industry in Sweden . Consensus price target broadly unchanged at kr374. Share price rose 8.3% to kr228 over the past week. Major Estimate Revision • Nov 21
Consensus revenue estimates fall by 16% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from kr627.2m to kr527.9m. EPS estimate fell from kr2.85 to kr1.89 per share. Net income forecast to shrink 14% next year vs 12% growth forecast for Biotechs industry in Sweden . Consensus price target broadly unchanged at kr372. Share price rose 3.3% to kr234 over the past week. Major Estimate Revision • Nov 15
Consensus revenue estimates fall by 14% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from kr729.8m to kr627.1m. EPS estimate fell from kr3.45 to kr2.84 per share. Net income forecast to shrink 1.5% next year vs 30% growth forecast for Biotechs industry in Sweden . Consensus price target down from kr392 to kr372. Share price rose 4.5% to kr223 over the past week. Recent Insider Transactions • Nov 10
Independent Chairman recently bought kr1.1m worth of stock On the 8th of November, Eugen Steiner bought around 5k shares on-market at roughly kr219 per share. This transaction amounted to 6.7% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Eugen's only on-market trade for the last 12 months. 
