Announcement • Jun 09
Orexo AB Announces Appointment of Raheleh Nassaji as Senior Vice President Business Development Orexo AB (publ.) had appointed Raheleh Nassaji as Senior Vice President Business Development. Raheleh Nassaji joined the company’s leadership team and reported to Nikolaj Sørensen, President and CEO. Raheleh is a biopharma executive with close to 20 years of global experience across big pharma and biotech. She brings a unique combination of scientific expertise, business development, and strategic partnerships gained through senior roles at companies across various stages of development, including Hansa Biopharma and Pfizer. Her background also includes late-stage product launches and commercialization as well as early-stage strategy and clinical development planning. This breadth of expertise enables her to bridge scientific innovation with commercial execution and strategic growth. Announcement • May 21
Orexo AB Announces Positive Outcome from In-Vivo Study of OX390 Orexo AB (publ.) announced positive data from a pre-clinical in-vivo study on the nasal absorption of atipamezole when delivered with Orexo's AmorphOX drug delivery technology. The study results mark an important milestone in the development of OX390, an emergency treatment to reverse overdoses involving xylazine and medetomidine, alpha-2 agonists often referred to as "Tranq" and "Rhino Tranq", respectively. The study demonstrated rapid and substantial intranasal absorption of atipamezole, successfully establishing proof-of-concept across multiple formulations. The results support that a single nasal dose of OX390 achieves exposure within the targeted therapeutic range. The next milestone in the project is an upcoming type C meeting with the FDA to agree on the non-clinical development plan that will enable human clinical trials. This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50125C00010. OX390 is designed to reverse respiratory depression associated with adulterated illicit opioid overdoses. Emerging evidence indicates that opioid-induced respiratory suppression (OIRD) may be greatly magnified in the presence of increasingly common adulterants, and that opioid antagonists such as naloxone and nalmefene may not be sufficient to revive victims of these overdoses. OX390 will be developed as a rapidly acting intranasal powder using Orexo's proprietary powder-based drug delivery technology AmorphOX for community-based use by first responders and laypersons. OX390 is an investigational compound, containing atipamezole, and is not approved for human use by the FDA. Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles that are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. Announcement • Mar 07
Orexo AB (publ.) Announces Executive Changes Orexo AB (publ.) on March 6, 2026 announced changes to its organizational structure and management team. The changes are a result of the divestment of Zubsolv in the US market and focus on advancing development programs and the AmorphOX technology. Lisa Moore, who has been part of Orexo's US leadership team since May 2024, will assume a new responsibility as Senior Vice President, Products and Portfolio Strategy. In her new role, she will be responsible for driving the long-term product vision for the development candidates, ensuring that the portfolio meets customer needs and that investment decisions support business growth. Lisa Moore is a biopharma industry leader with more than 25 years of experience in commercial, new product planning, and strategy roles. Prior to joining Orexo in 2024, she was Vice President, Global Commercial Strategy at Emergent, where she also led the commercial valuation of M&A opportunities. She has previously held management positions at MedImmune, Parke-Davis, Baxter International, and Merck. Lisa Moore will be a part of Orexo´s management team and report directly to the CEO. She will participate in Orexo's R&D Day on March 24, 2026 in Stockholm. Robert DeLuca, President of Orexo US Inc. since the launch of the US commercial organization in 2013, has been instrumental in building the US business, leading the successful commercialization of Zubsolv and advancing Orexo's mission to help curb the US opioid epidemic. Robert DeLuca will retire from his role at the company. Robert DeLuca will continue in his role as President of Orexo US Inc. through May 2026. He will also, after May continue to support the company with strategic projects and with the transition of Zubsolv US to Dexcel Pharma USA in an advisory role. Announcement • Jan 23
Orexo AB (publ) to Report Fiscal Year 2025 Results on Feb 05, 2026 Orexo AB (publ) announced that they will report fiscal year 2025 results at 7:00 AM, Central European Standard Time on Feb 05, 2026 New Risk • Jan 03
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 4.0% 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. Currently, the following risks have been identified for the company: Major Risks Negative equity (-kr224m). Earnings are forecast to decline by an average of 4.0% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr223m net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Announcement • Jan 02
Dexcel Pharma USA, LLC acquired Zubsolv US business from Orexo AB (publ) (OM:ORX). Dexcel Pharma USA, LLC signed an asset purchase agreement to acquire Zubsolv US business from Orexo AB (publ) (OM:ORX) for approximately $110 million on December 22, 2025. The consideration includes a cash payment of $91 million will be paid and a contingent payment of up to $16.8 million based on future Zubsolv net sales during 2026 and 2027. Of this amount, $3 million will be deposited into an escrow account and $4–5 million relating to the acquired inventory. As part of consideration, $107.8 million is paid towards assets of Zubsolv US business of Orexo.
The Zubsolv US business had net sales LTM of $49 million and EBIT of $17 million. The transaction is expected to close by January 31, 2026.
Leerink Partners LLC acted as financial advisor for Orexo AB. Steptoe LLP acted as legal advisor for Orexo AB.
Dexcel Pharma USA, LLC completed the acquisition of Zubsolv US business from Orexo AB (publ) (OM:ORX) on December 31, 2025. Announcement • Oct 18
Orexo AB (publ), Annual General Meeting, Mar 02, 2026 Orexo AB (publ), Annual General Meeting, Mar 02, 2026. Announcement • Sep 06
Orexo AB (Publ) Announces Positive Pharmacokinetic In-Vivo Data for A Powder-Based Intranasal Semaglutide Formulation Developed with the Amorphox Technology Orexo AB (publ.) announced positive pharmacokinetic in-vivo data for a powder-based intranasal semaglutide formulation developed with the AmorphOX technology. In the in-vivo study, three different formulations of powder semaglutide were administered intranasally. For comparison, Rybelsus®?, a semaglutide tablet, was administered orally, and Wegovy®?, injectable semaglutide, was administered subcutaneously. At the median values, two of the AmorphOX powder formulations had a sevenfold increase in plasma values when compared to the oral tablet, although as expected they had lower values than the injectable. In addition to higher exposure than the oral route, the AmorphOX formulations exhibited lower variability in plasma concentration. The data generated further supports the ability of the AmorphOX technology to formulate large molecules into powders that could be delivered intranasally. An AmorphOX-formulated intranasal semagLutide may provide needle-free delivery with improved convenience, potentially better adherence, and would not require refrigeration. Dosing schedules, depending on intranasal dosage strength and therapeutic levels achieved, may also be extended to require less frequent dosing than the oral route. Announcement • Apr 10
Orexo Announces Positive In-Vivo Proof-Of-Concept Data for Powder-Based Intranasal Vaccine Formulated with the Amorphox Technology Orexo AB (publ.) announced positive in-vivo proof-of-concept data for a powder-based intranasal vaccine candidate formulated with the AmorphOX technology. The data was generated under the collaboration between Orexo and Abera Biosciences ("Abera") entered in December 2024. The proof-of-concept study was conducted in rats where Abera's influenza vaccine candidate was administered intranasally, either formulated as a liquid nasal solution or as an intranasal powder using Orexo's AmorphOX technology. Both formulations induced strong systemic antibody response in serum (IgG) as well as locally in the nose and lungs (IgA). No difference in immune response was seen between the liquid nasal solution and the intranasal powder. An intranasal influenza vaccine has the potential to easily and effectively help reduce the spread of infections and prevent disease, which could play an important role in a potential future pandemic. Formulating vaccines in powder form using the AmorphOX technology provides the potential to develop cost-efficient, thermostable vaccines with no need for cold chain requirements. Announcement • Apr 03
Orexo AB (publ), Annual General Meeting, May 08, 2025 Orexo AB (publ), Annual General Meeting, May 08, 2025, at 16:00 W. Europe Standard Time. Location: at rapsgatan 28 in uppsala, Sweden Announcement • Mar 26
Orexo AB (publ) to Report Fiscal Year 2024 Final Results on Mar 28, 2025 Orexo AB (publ) announced that they will report fiscal year 2024 final results at 9:00 AM, Central European Standard Time on Mar 28, 2025 Announcement • Jan 10
Orexo AB (publ) Announces Positive Topline Results from the Clinical Study OX640-002 Orexo AB (publ.) announced positive topline results from the clinical study OX640-002. The study evaluated the performance in subjects with and without allergic rhinitis when treated with Orexo's nasal rescue medication including powder-based epinephrine, OX640. The study was a cross-over study in 30 subjects assessing absorption and pharmacodynamic effects of epinephrine from two doses of OX640, with one of the doses also administered during ongoing allergic rhinitis symptoms. Exposure was compared to a commercial intramuscular injection. Topline data analysis demonstrates that OX640 treatments achieved mean epinephrine plasma levels associated with clinical efficacy more rapidly than the intramuscular injection, with dose-dependent exposure levels. Absorption under allergic rhinitis conditions was significantly faster than under normal conditions, supporting rapid onset of effect also in patients with significant airway symptoms. OX640 formulations typically produced more pronounced increases in blood pressure and heart rate than the intramuscular injections, which are key effects for treatment of anaphylaxis. Systemic safety was in line with the known pharmacology of epinephrine and local effects were transient and tolerated. There were no severe or serious adverse events. Announcement • Dec 16
Orexo Resolves Zubsolv US Patent Litigation with Sun Pharmaceutical Industries Orexo AB (publ.) announced that it has entered into a settlement agreement with Sun to resolve the patent litigation regarding Zubsolv® (buprenorphine and naloxone) sublingual tablet (CIII), for the treatment of opioid use disorder in the US. The agreement resolves the patent litigation commenced in 2020 by Orexo following Sun's filing of an Abbreviated New Drug Application ("ANDA") seeking approval to market generic versions of Zubsolv in the US prior to the expiration of Orexo's patents listed in FDA's Orange Book for Zubsolv. The agreement allows Sun to enter the US market with its generic versions of Zubsolv in September 2030. Zubsolv is protected by ten patents in the US with expiration dates ranging from 2027 to 2032. This settlement agreement does not implicate its patent protection. Breakeven Date Change • Oct 28
No longer forecast to breakeven The analyst covering Orexo no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of kr15.1m in 2026. New forecast suggests the company will make a loss of kr20.2m in 2026. Reported Earnings • Oct 25
Third quarter 2024 earnings released: kr1.21 loss per share (vs kr0.97 loss in 3Q 2023) Third quarter 2024 results: kr1.21 loss per share (further deteriorated from kr0.97 loss in 3Q 2023). Revenue: kr136.5m (down 13% from 3Q 2023). Net loss: kr41.9m (loss widened 26% from 3Q 2023). Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 25% per year but the company’s share price has fallen by 33% per year, which means it is significantly lagging earnings. Announcement • Oct 23
Orexo AB (publ) Initiates New Study of OX640 in Participants with Allergic Rhinitis Orexo AB (publ.) announced the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine, in a new study in subjects with allergic rhinitis (hay fever). The study will be completed during 2024 with results available early in 2025. Following the positive results from the phase 1 clinical study, OX640-001, where OX640 showed absorption of epinephrine and effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector, Orexo now advances the development of OX640. In the new study, OX640-002, the epinephrine absorption from OX640 will be investigated in participants with and without allergic symptoms in the nose. As patients may experience allergic symptoms in the nose during anaphylaxis, it is critical to understand the absorption of epinephrine from Orexo's unique powder formulation under these conditions. The study is a cross-over study in 30 participants with allergic rhinitis and involves four treatment periods. In one of the periods, a small dose of an allergen will be sprayed into the nose of the participants to trigger an allergic reaction before being treated with OX640. This will be compared with absorption of epinephrine from OX640 without the allergen, and a commercial intramuscular epinephrine product. The fourth period will be used to document dose proportionality of OX640. In addition to the absorption of epinephrine, effects on blood pressure and heart rate will be measured as relevant parameters to understand the effect of OX640 in case of an anaphylaxis. Announcement • Oct 04
Orexo AB (publ) Announces Nomination Committee for the Annual General Meeting 2025 Orexo AB (publ) announced members of the Nomination Committee for the Annual General Meeting (AGM), that takes place on May 8, 2025, have been appointed and comprises of the following members: Henrik Kjaer Hansen, (Chairman, appointed by Novo Holdings A/S); Claus Berner Møller, (appointed by The Danish Labour Market Supplementary Pension, ATP); Stefan Hansson, (private investor); James Noble, (Chairman of the Board of Orexo); The Nomination Committee represents approximately 34% of the number of votes in the company as of August 31, 2024. The Nomination Committee will prepare proposals to the AGM regarding Chairman of the meeting, Chairman of the Board, Board members, Board member fees, any remuneration for committee work, and fees to the auditor, as well as principles for the composition of the Nomination Committee. Reported Earnings • Jul 18
Second quarter 2024 earnings released: kr1.04 loss per share (vs kr0.37 loss in 2Q 2023) Second quarter 2024 results: kr1.04 loss per share (further deteriorated from kr0.37 loss in 2Q 2023). Revenue: kr154.0m (down 2.3% from 2Q 2023). Net loss: kr35.9m (loss widened 185% from 2Q 2023). Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 25% per year, which means it is significantly lagging earnings. Recent Insider Transactions • Jun 10
Independent Chairman of the Board recently bought €24k worth of stock On the 5th of June, James Noble bought around 13k shares on-market at roughly €1.84 per share. This transaction amounted to 25% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. James has been a buyer over the last 12 months, purchasing a net total of €55k worth in shares. New Risk • May 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.3% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (7.3% average weekly change). Market cap is less than US$100m (€63.7m market cap, or US$69.2m). Announcement • May 17
Orexo AB (publ) to Report Q3, 2024 Results on Oct 24, 2024 Orexo AB (publ) announced that they will report Q3, 2024 results on Oct 24, 2024 Reported Earnings • May 08
First quarter 2024 earnings released: kr0.26 loss per share (vs kr1.86 loss in 1Q 2023) First quarter 2024 results: kr0.26 loss per share (improved from kr1.86 loss in 1Q 2023). Revenue: kr139.3m (down 12% from 1Q 2023). Net loss: kr8.90m (loss narrowed 86% from 1Q 2023). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 17% per year but the company’s share price has fallen by 28% per year, which means it is significantly lagging earnings. Announcement • Apr 17
Orexo Extends Patent Protection for Its Nasal Epinephrine Powder Product OX640 in the US Orexo AB announces that the United States Patent and Trademark Office (USPTO) has granted another US patent specifically related to OX640, Orexo's nasal epinephrine powder product based on the AmorphOX® drug delivery platform. In August 2023, the USPTO granted the first patent for OX640 in the US, providing protection until May 2041. The newly issued patent, US Patent No. 11,957,647, provides both expanded scope of protection as well as longer patent term, now extending until November 2042. Orexo has multiple patent applications filed on a global basis and expects to continuously strengthen the patent portfolio for OX640. Reported Earnings • Mar 31
Full year 2023 earnings released: kr3.73 loss per share (vs kr5.17 loss in FY 2022) Full year 2023 results: kr3.73 loss per share (improved from kr5.17 loss in FY 2022). Revenue: kr638.8m (up 2.3% from FY 2022). Net loss: kr128.3m (loss narrowed 28% from FY 2022). Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 3.4% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 34% per year, which means it is significantly lagging earnings. Announcement • Mar 22
Orexo AB (Publ) Announces Board Resignations Orexo AB (publ) announced the board members Mary Pat Christie, Charlotte Hansson and Michael J Matly have declined re-election. New Risk • Feb 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr114m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr114m free cash flow). Earnings have declined by 54% per year over the past 5 years. Minor Risks Share price has been volatile over the past 3 months (7.4% average weekly change). Market cap is less than US$100m (€44.7m market cap, or US$48.3m). Reported Earnings • Feb 08
Full year 2023 earnings released: kr3.73 loss per share (vs kr5.17 loss in FY 2022) Full year 2023 results: kr3.73 loss per share (improved from kr5.17 loss in FY 2022). Revenue: kr638.8m (up 2.3% from FY 2022). Net loss: kr128.3m (loss narrowed 28% from FY 2022). Revenue is forecast to grow 11% p.a. on average during the next 2 years, compared to a 3.1% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 35% per year, which means it is significantly lagging earnings. Announcement • Feb 08
Orexo AB (publ) to Report Q4, 2024 Results on Feb 06, 2025 Orexo AB (publ) announced that they will report Q4, 2024 results at 8:00 AM, Central European Standard Time on Feb 06, 2025 Announcement • Nov 29
Orexo AB (Publ) Announces FDA Acceptance of New Drug Application Filing for OX124 Orexo AB (publ.) announced the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo's world-classdrug delivery platform, amorphOX. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay. OX124 will meet the growing need for more powerful medications to improve the possibility of reviving individuals experiencing an overdose caused by use of synthetic opioids, such as fentanyl, which cause 91% of all fatal opioid overdoses. OX124 is a potent medication and, in combination with rapid absorption and high bioavailability, this makes it capable of reversing an overdose or sustaining consciousness in a patient who has taken synthetic opioids. A MorphOX is an innovative powder-based technology that, in addition to rapid absorption and high bioavailability., improves stability and reduces sensitivity related to temperature changes. For users and lay-people OX124 has the potential to become an efficient and reliable rescue medication independent of temperature variations during storage, for example its efficacy is not affected at freezing temperatures. OX124 is protected by patents until 2039. Driven by the need to increase access to overdose medication, low-dose products, including the market leader, have recently been approved by the FDA as non-prescription over-the-counter (OTC) products. Historically, OTC products in the US have had limited reimbursement from insurance companies and, when applying similar industry analogues going forward, this may provide an advantage to high-dose prescription naloxone products, such as OX124. In addition, high-dose prescription products are expected to benefit from the continued expansion of mandatory co-prescription of naloxone when prescribing opioids to at-risk patients suffering from pain. Breakeven Date Change • Nov 21
No longer forecast to breakeven The 2 analysts covering Orexo no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr12.0m in 2025. New consensus forecast suggests the company will make a loss of kr12.2m in 2025. Reported Earnings • Nov 03
Third quarter 2023 earnings released Third quarter 2023 results: Revenue: kr156.1m (down 3.0% from 3Q 2022). Net loss: kr33.3m (loss widened 26% from 3Q 2022). Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 3.1% growth forecast for the Pharmaceuticals industry in Germany. Announcement • Oct 24
Orexo AB (publ), Annual General Meeting, Apr 26, 2024 Orexo AB (publ), Annual General Meeting, Apr 26, 2024. Announcement • Oct 11
Orexo AB (publ) Announces Data from the MODIA Study Evaluating Impact on Use of Illicit Opioids Orexo AB (publ) reported top line results after having completed a study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/naloxone for the treatment of opioid use disorder (OUD) and reduction in use of illicit opioids. The study had unexpectedly high treatment response rates for both treatment arms, with no statistically significant difference in treatment response in the full population. No adverse events associated with the use of MODIA were reported. An exploratory analysis of patients randomized to MODIA found that those who completed all 24 modules had a significantly higher rate of treatment response than those who did not complete the entire program. A comprehensive Medication-Assisted Treatment (MAT) approach that combines medications for OUD with psychosocial support is recommended for optimal outcomes. Education of patients with OUD is critical to help them understand their disease, their treatment, and strategies to support their recovery. As a browser-based digital program that can be accessed remotely at any time, MODIA provides flexible access to educational content and exercises that are based on cognitive behavioral therapy principles. The study was a randomized, open-label, parallel-group study, enrolling patients aged 18 to 65 across the US who voluntarily sought treatment for documented moderate to severe OUD. Participants were inducted and stabilized on buprenorphine/naloxone during a brief screening period, then evaluated during weekly visits over the course of 24 weeks, with a primary endpoint defined as the subject having =80 percent of urine drug tests negative for illicit opioids and negative self-reports for illicit opioid use during the final 20 weeks of the study. Patients were randomized to receive weekly medication management i.e., background study care (BSC), or BSC in addition to MODIA. The study enrolled 437 patients at 36 centers across the US. Study completion rates were similar (55% BSC, 52% MODIA), as were treatment response rates (32% BSC, 31% MODIA). There was no statistically significant difference between treatment arms in any pre-specified endpoint of the study. These unexpectedly high treatment response rates exceeded those of similarly designed trials of long-acting injectable buprenorphine, which had 18 and 24 study visits (17% and 29%, respectively). An exploratory analysis of the 219 patients randomized to MODIA who subsequently completed the entire study (n=114), found that the 61 patients that completed all 24 modules of MODIA had a significantly higher treatment response rate of 61% than those that did not complete the entire program (n=53), who had a treatment response rate of 38% (p=0.0146). The difference in treatment response rate emerged after completion of 12 modules. In addition, the study showed indications of improved psychosocial outcome for those who completed MODIA which will be explored further in continued post hoc analysis. MODIA is designed to educate patients on behavioral changes that can support their recovery journey, and to empower them with techniques to help them cope with the challenges of everyday life. To support the patients’ healthy recovery, adherence to the program is important and Orexo will work with the developer of MODIA, GAIA AG to add functionality to MODIA to further improve adherence. In the study 38% of patients reported at least one adverse event. Overall reporting of adverse events was similar between treatment arms, and no adverse events associated with the use MODIA were reported. The company will continue to commercialize MODIA with limited changes as a mobile medical device subject to FDA enforcement discretion following the expected expiration of the COVID Public Health Emergency Guidance in November 2023. Under enforcement discretion MODIA will be positioned as a supportive resource for patients undergoing a clinician-directed treatment, rather than as a physician-prescribed treatment regimen. The study results indicate there is high value in the combination of high frequency interactions with health care providers and completion of the MODIA program, as well as MODIA’s strong safety profile. The company is continuing to analyze the study data and will continue to collect data to show the value of MODIA in supporting the patients with OUD to get their lives back. Announcement • Oct 05
Orexo AB (Publ) Announces Henrik Kjær Hansen Will Resign from the Board of Directors Orexo AB (publ) announced that the board member Henrik Kjær Hansen will resign from the board of directors in connection with the Extraordinary General Meeting. Announcement • Sep 18
Orexo AB (publ.) Submits New Drug Application to FDA for OX124, a High-Dose Rescue Medication for Opioid Over Overio Overio Overio Overio Orexo AB (publ.) announced the submission of the New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OX124, a high-dose rescue medication for opioid overdose with nasal delivery. OX124, is based on Orexo's world-class drug delivery platform amorphOX®? and is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl. The submission is supported by data from the pivotal study in healthy volunteers, OX124-002, where OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In addition, development formulations of OX124 have in a previous exploratory clinical study (OX124-001) in healthy volunteers, demonstrated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator. OX124 is protected by patents until 2039. If approved OX124 will meet the significant and growing need of more powerful rescue medications improving the possibility to revive individuals who have got an overdose caused by use of synthetic opioids, such as opioid. During the latest 12-month period, ending April 2023, the predicted annual number of fatal overdoses in the US encountered for more than 110.000. The great majority, 76%, refers to opioid overdoses, and of these 91% involved synthetic opioids. The technical issues with the packaging process, which earlier this year gave rise to FDA's request for filing a new NDA, have now been solved in partnership with the contract manufacturer. To ensure the manufacturing process meets the reliability requirements, tests, and qualifications have successfully been conducted at the contract manufacturers site. FDA's review process is expected to take ten to thirteen months. Orexo is planning to initiate the US launch late in second half of 2024 or early 2025. Reported Earnings • Jul 19
Second quarter 2023 earnings released Second quarter 2023 results: Revenue: kr157.7m (up 6.7% from 2Q 2022). Net loss: kr12.6m (loss narrowed 65% from 2Q 2022). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 3.2% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 52% per year but the company’s share price has only fallen by 36% per year, which means it has not declined as severely as earnings. New Risk • Jul 04
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr218m Forecast net loss in 2 years: kr28m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr28m net loss in 2 years). Market cap is less than US$100m (€54.6m market cap, or US$59.6m). Breakeven Date Change • Jul 03
Forecast breakeven date pushed back to 2025 The 2 analysts covering Orexo previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 52% per year to 2024. The company is expected to make a profit of kr12.0m in 2025. Average annual earnings growth of 81% is required to achieve expected profit on schedule. Reported Earnings • Apr 28
First quarter 2023 earnings released First quarter 2023 results: Revenue: kr158.8m (flat on 1Q 2022). Net loss: kr63.9m (loss widened 171% from 1Q 2022). Revenue is forecast to grow 11% p.a. on average during the next 3 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Breakeven Date Change • Apr 27 The 2 analysts covering Orexo previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 13% to 2023. The company is expected to make a profit of kr50.0m in 2024.
Announcement • Feb 03
Orexo AB (publ) Submits New Drug Application to FDA for OX124, A High-Dose Rescue Medication for Opioid Overdose Orexo AB (publ.) announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose. OX124, is based on Orexo´s drug delivery platform amorphOX® and contains a high-dose of naloxone. The submission is supported by data from the pivotal study in healthy volunteers, OX124-002, where OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In addition, development formulations of OX124 have in a previous exploratory clinical study (OX124-001) in healthy volunteers, demonstrated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator. OX124 is protected by patents until 2039. Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression. Opioid overdoses can be treated with the opioid antagonist naloxone. During the 12-month period ending August 2022, the predicted annual number of fatal opioid overdoses in the US exceeded 81,000. Nine out of ten opioid overdose deaths involved synthetic opioids, including fentanyl. The switch to highly potent synthetic opioids has led to more severe overdoses, prompting the need for high-dose naloxone products. Reported Earnings • Jan 27
Full year 2022 earnings released: kr5.17 loss per share (vs kr6.51 loss in FY 2021) Full year 2022 results: kr5.17 loss per share (improved from kr6.51 loss in FY 2021). Revenue: kr624.3m (up 11% from FY 2021). Net loss: kr177.6m (loss narrowed 21% from FY 2021). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 48 percentage points per year, which is a significant difference in performance. Announcement • Jan 09
Orexo AB (publ.) Initiates Exploratory Feasibility Studies of amorphOX with Two Leading Biopharmaceutical and Vaccine Companies Orexo AB (publ.) announced the company has initiated two exploratory feasibility studies, applying the proprietary drug delivery platform amorphOX to protein based pharmaceuticals and vaccines in collaboration with leading international biopharmaceutical and vaccine companies. The feasibility studies follow successful formulation of the Covid-19 spike protein in amorphOX. Orexo has expanded the application of the amorphOX platform, from small molecules to also cover larger biomolecules. The company has tested enzymes, peptides and proteins in amorphOX and seen significant improvement in stability compared to other formulations in a wide range of storage temperatures. In the recent study with Covid-19 spike protein, Orexo measured the activity level of the protein after one month storage in both intermediate and high temperatures. Data showed formulations based on amorphOX managed to fully maintain activity levels after one month, even at high storage temperature. amorphOX has also been tested in multiple clinical studies with several different APIs (Active Pharmaceutical Ingredients) and consistently showed superior nasal absorption and bioavailability to competing drug delivery technologies. To test the ability of amorphOX as a platform for biopharmaceuticals, Orexo will work with companies having unique biomolecules or technologies. Today's announcement of collaborations with two leading international biopharmaceutical and vaccine companies is based on shared risk projects, where the parties will assess the feasibility of the biomolecules supplied by the partners in amorphOX formulations. Orexo will lead the formulation and manufacturing work, whereas the partner will be responsible for testing the product and to assessing future commercial opportunities of a partnership. Reported Earnings • Nov 05
Third quarter 2022 earnings released Third quarter 2022 results: Revenue: kr161.0m (up 10% from 3Q 2021). Net loss: kr26.5m (loss narrowed 49% from 3Q 2021). Revenue is forecast to grow 23% p.a. on average during the next 3 years, compared to a 4.0% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 73 percentage points per year, which is a significant difference in performance. Announcement • Oct 28
Orexo AB (publ) Announces Last Patient Enrolled in Pivotal Study Evaluating the Efficacy of MODIA® in Combination with Sublingual Buprenorphine/ Naloxone for the Treatment of OUD Orexo AB (publ) announced the last participant has enrolled in the pivotal study of the digital therapeutic MODIA® as part of a clinician supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD). The randomized, open-label, parallel-group study is evaluating whether the use of MODIA® in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce illicit opioid use. The study enrolled 437 participants at 35 sites across the US who voluntarily sought treatment for documented moderate to severe OUD. The company brings deep category expertise to the research effort, having served the US OUD market extensively over the last nine years through its efforts with ZUBSOLV® (buprenorphine and naloxone) sublingual tablets. The US opioid epidemic has claimed one million lives over the past two decades and is being driven by illicit opioids. The opioid epidemic has worsened during the COVID-19 pandemic. More Americans died of drug overdoses in 2021 than any previous year, including more than 80,000 deaths involving opioids. MODIA® has been co-developed with GAIA, a leading global DTx company based in Hamburg, Germany, which has over two decades of industry leading DTx evidence development across multiple therapeutic categories. In addition to GAIA's significant research experience and Orexo's expertise in OUD, patients with OUD were also included in the development and initial product testing of MODIA®, offering a highly unique patient perspective that drives the therapeutic experience. Announcement • Oct 26
Orexo AB (publ) Appoints Edward Kim, M.D., as New Chief Medical Officer Orexo AB (publ.) welcomed Edward (Ed) Kim, M.D., as new Chief Medical Officer (CMO). Ed Kim will succeed Michael Sumner, M.D., who has held this role since 2013. He is located at Orexo´s US subsidiary in Morristown, New Jersey. Ed Kim´s primary responsibilities will include leading the US Medical Affairs Department concentrating on commercial products in pharmaceuticals and digital therapeutics. Additionally, he will work closely with the Swedish pharmaceutical development team to further drive innovative treatment solutions based on Orexo's amorphOX® platform, with a focus on new innovative treatments for patients suffering from substance use disorders and other mental health issues. Ed Kim began his career with 13 years of clinical practice as a board certified psychiatrist, including several years in a senior leadership role with a large behavioral health system. He then acquired more than 16 years' experience within the pharmaceutical industry, most recently as Vice President and Head of Medical Affairs at Biohaven Pharmaceuticals. His proven track record is derived from extensive experience as a clinician, leader, and scientist across multiple senior positions within medical affairs, health economics and clinical development in psychiatry and the neuroscience therapeutic area. Announcement • Oct 18
Orexo AB (publ), Annual General Meeting, Apr 18, 2023 Orexo AB (publ), Annual General Meeting, Apr 18, 2023. Announcement • Oct 11
Orexo Announces Positive Data from Phase 1 Clinical Study for OX640 Orexo AB (publ) announces positive results from the first explorative human clinical study (OX640-001) for its nasal epinephrine (adrenaline) rescue medication for allergic reactions, OX640. The study was a comparative bioavailability study performed in 40 healthy volunteers assessing four investigational formulations of OX640 compared to a marketed epinephrine auto-injector. All four investigational formulations were extensively absorbed and rapidly achieved clinically relevant plasma levels of epinephrine comparable to the reference product. Furthermore, all four OX640 formulations showed concentration dependent effects on heart rate and blood pressure, a pharmacological response relevant for the treatment of allergic reactions. Local and systemic safety findings were generally consistent with known effects of epinephrine and there were no findings that raised any safety concerns. Reported Earnings • Jul 15
Second quarter 2022 earnings released Second quarter 2022 results: Revenue: kr147.8m (up 3.5% from 2Q 2021). Net loss: kr35.8m (loss narrowed 51% from 2Q 2021). Over the next year, revenue is forecast to grow 7.4%, compared to a 7.6% growth forecast for the industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 80 percentage points per year, which is a significant difference in performance. Announcement • Jul 05
Orexo AB (Publ.) Announces Successfully Initiated the First Explorative Human Clinical Study for Ox640 Orexo AB (publ.) announced it has successfully initiated the first explorative human clinical study for OX640. The study aims to determine the relative bioavailability and absorption characteristics of investigational OX640 formulations versus an intramuscular adrenaline injection in healthy volunteers. Adrenaline is commonly used for the emergency treatment of allergic reactions, including anaphylaxis. First line treatments are intramuscular auto-injector products. Since adrenaline is a very sensitive active ingredient that easily undergoes degradation, currently marketed injection products all contain antioxidant chemical additives to help reduce degradation. Despite these additives, and that these products require strictly controlled handling and storage, they still suffer from having limited shelf-life . Orexo’s OX640 product is a nasal adrenaline formulation based on its proprietary drug delivery platform amorphOX. Stability data generated so far for OX640 strongly indicates the potential for an adrenaline product with significantly improved stability versus today’s injection products, both in terms of allowed storage temperatures as well as shelf-life. These encouraging data has been obtained without the addition of any antioxidants. In addition to offering allergic patients with a product that provides greater flexibility in terms of handling and storage, OX640 provides a less bulky, more convenient and needle-free alternative to auto-injectors. Reported Earnings • Apr 29
First quarter 2022 earnings released First quarter 2022 results: Revenue: kr159.4m (up 21% from 1Q 2021). Net loss: kr23.6m (loss narrowed 25% from 1Q 2021). Over the next year, revenue is expected to shrink by 2.0% compared to a 8.0% growth forecast for the industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 73 percentage points per year, which is a significant difference in performance. Announcement • Apr 22
Orexo AB (publ) Announces Board Appointments Orexo AB (publ) announced that Christine Rankin and Michael J Matly were elected as new members of the board. James Noble was elected as chairman of the board at its annual general meeting held on 21 April 2022. Reported Earnings • Apr 04
Full year 2021 earnings released: kr6.51 loss per share (vs kr2.45 loss in FY 2020) Full year 2021 results: kr6.51 loss per share (down from kr2.45 loss in FY 2020). Revenue: kr565.0m (down 15% from FY 2020). Net loss: kr223.5m (loss widened 165% from FY 2020). Products in clinical trials Phase I: 2 Phase II: 1 Phase III: 1 Over the next year, revenue is expected to shrink by 1.6% compared to a 8.2% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 61 percentage points per year, which is a significant difference in performance. Reported Earnings • Jan 28
Full year 2021 earnings: Revenues and EPS in line with analyst expectations Full year 2021 results: kr6.51 loss per share (down from kr2.45 loss in FY 2020). Revenue: kr565.0m (down 15% from FY 2020). Net loss: kr223.5m (loss widened 165% from FY 2020). Revenue was in line with analyst estimates. Over the next year, revenue is forecast to grow 3.5%, compared to a 7.0% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 65 percentage points per year, which is a significant difference in performance. Announcement • Jan 28
Orexo AB (publ) to Report Q4, 2022 Results on Jan 26, 2023 Orexo AB (publ) announced that they will report Q4, 2022 results at 8:00 AM, Central European Standard Time on Jan 26, 2023 Announcement • Dec 03
Orexo AB (Publ.) Develops Nasal Adrenaline Medication Based on the Novel Amorphox Platform Orexo AB (publ.), announces it has initiated a new pharmaceutical development project, OX640, a nasal adrenaline product for the emergency treatment of allergic reactions. Adrenaline is commonly used for the emergency treatment of allergic reactions, including anaphylaxis, which is a global and growing health problem. The market size exceed USD 2 billion and is expected to show continuous strong growth in the coming years. The market is currently dominated by the use of auto-injectors for intramuscular or subcutaneous administration of injection solutions of adrenaline, although new delivery alternatives are under development. Adrenaline is a very unstable active ingredient sensitive to chemical degradation, which is the reason why commercial adrenaline products have limited shelf-life with restrictive storage conditions. OX640 is based on Orexo's proprietary drug delivery platform amorphOXTM, and shows promising chemical and physical stability data. In addition to providing allergic patients with a more convenient, needle-free alternative to auto-injectors currently on the market, an adrenaline product that provides greater flexibility in relation to how it can be handled and stored should provide significant benefits to patients and healthcare systems, ensuring the correct adrenaline dose is available when needed. Orexo has consulted with the US Food & Drug Administration on the development of OX640 and on the basis of their feedback outlined a development pathway. Orexo is currently optimizing the OX640 formulation and expects to perform a first explorative human clinical pharmacokinetic study in the second half of 2022. The results of the study are decisive for the final development plan and timeline. Furthermore, Orexo will be able to leverage investments and learnings made from the OX124 and OX125 projects (overdose rescue medications) in the continued development and future commercial manufacturing of OX640. Orexo will consider the right partnership strategy for the product, but will explore opportunities for development- and commercialization partnerships during 2022. Announcement • Nov 27
Orexo AB Provides Information About Its New Proprietary Drug Delivery Platform - Amorphox Orexo AB provides information about its new proprietary drug delivery platform, amorphOXTM, a novel and inventive powder-based technology with significant potential. Several new patent applications directed to amorphOXTM have now been filed, which should serve to protect the technology until 2042. The amorphOXTM powder technology is made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, commonly a significant problem with amorphous drug compositions. Significantly, the amorphOXTM platform has been shown to work for a broad scope of different active ingredients enabling drug development in many different fields. Drug products using amorphOXTM display nearly instant dissolution even in very limited amounts of liquids, making it an ideal choice for the development of drugs targeting administration sites such as the nasal and sublingual cavities. Rapid dissolution of drug products provides for important opportunities when, for example, developing drugs requiring a rapid onset of action. The amorphOXTM platform has been validated in various in vivo studies, including human clinical trials, demonstrating rapid and extensive absorption of various drugs. The platform is well-tolerated and shows a low degree of inter-patient variability. Orexo's first product based on the amorphOXTM platform, OX124 - an overdose rescue medication - has been shown to provide superior pharmacokinetic properties compared to the market leading liquid-based nasal spray product. The commercial supply chain established for OX124 will help shorten timelines and reduce risk of future products based on nasal delivery. Reported Earnings • Nov 04
Third quarter 2021 earnings released: kr1.52 loss per share (vs kr2.45 loss in 3Q 2020) The company reported a decent third quarter result with reduced losses and improved control over expenses, although revenues were weaker. Third quarter 2021 results: Revenue: kr145.9m (down 2.9% from 3Q 2020). Net loss: kr52.0m (loss narrowed 39% from 3Q 2020). Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 63 percentage points per year, which is a significant difference in performance. Reported Earnings • Jul 16
Second quarter 2021 earnings released: kr2.15 loss per share (vs kr0.94 loss in 2Q 2020) The company reported a poor second quarter result with increased losses, weaker revenues and weaker control over costs. Second quarter 2021 results: Revenue: kr142.8m (down 20% from 2Q 2020). Net loss: kr73.7m (loss widened 127% from 2Q 2020). Announcement • Jul 16
Orexo AB (Publ) Pharmaceutical Pipeline Asset Ox124 Enters Pivotal Trial Orexo AB (publ.) announced that the company has successfully initiated the pivotal trial (OX124-002) for its lead pharmaceutical pipeline asset, OX124. The first cohort of healthy volunteers has been dosed on July 15, 2021. OX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl. To meet the target profile for more potent rescue medications, the company has developed a novel and unique intranasal formulation technology that allows for rapid and efficient delivery of active ingredients through the intranasal route. The use of synthetic opioids is the leading cause of death in fatal overdoses in the US, a trend that has seen further acceleration in the wake of the Covid-19 pandemic. For the full year of 2020, the number of overdose deaths surpassed 92,000 for the first time in history, an increase of 30% versus the previous year. Approximately 75% of these deaths were caused by opioids, and within the opioid-related deaths, synthetic opioids accounted for the vast majority, underlining the need for more powerful and faster-acting rescue medications. The pivotal trial OX124-002 is a 4-period cross-over, comparative bioavailability study in healthy volunteers, comparing two dose regimens of OX124 to two dose regimens of an injection reference product. The study is intended to be the primary support for the OX124 New Drug Application in the US. Initial study results are expected in Fourth Quarter 2021, and if successful, the company is expecting to file OX124 with the US Food and Drug Administration in the second half of 2022. In a previous exploratory clinical study (OX124-001) in healthy volunteers, OX124 showed more rapid absorption, substantially higher plasma concentrations of naloxone, and sustained duration of elevated plasma concentrations when compared to the current market leader. The addressable market for OX124 is large and growing as demand for easy to use, potent overdose reversal medication increases, not only for emergency staff and first responders, but also for opioid dependent patients, and as co-prescription for high-dose opioid pain patients. According to the company's estimates, greater levels of co-prescriptions and expanding access for opioid dependent patients may increase the market size from today's USD 300 - 500 million to USD 1.5 - 2 billion. If the project progresses according to the current plan, the US launch can take place in 2023. If approved, OX124 is estimated to have a sales potential of USD 70 - USD 110 million. Announcement • Jul 01
Orexo Announces First Patient Enrolled in Pivotal Study Evaluating the Efficacy of Modia™ in Combination with Sublingual Buprenorphine/ Naloxone for the Treatment of OUD Orexo AB (publ.) announces the enrollment of the first participant in the pivotal study of digital therapeutic modia(TM), in combination with sublingual buprenorphine/naloxone, as part of a clinician-supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD). The randomized, open-label, parallel-group study will evaluate whether the use of modia(TM) in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce illicit opioid use. The study is designed to enroll an estimated 400 participants at 35 sites across the US who are voluntarily seeking treatment for documented moderate to severe OUD. Orexo brings deep category expertise to the research effort, having served the US OUD market extensively over the last eight years through its efforts with ZUBSOLV® (buprenorphine and naloxone) sublingual tablets, among other things. The opioid epidemic has continued to grow during the COVID-19 pandemic, with the number of fatal opioid overdoses reaching more than 67,500, an increase of 36%, from December 1, 2019, to November 30, 2020.[1] Improving access to new, innovative treatments like modia(TM) may help reverse the epidemic's continued development. Recent Insider Transactions • May 30
Independent Director recently bought €10k worth of stock On the 25th of May, Charlotte Hansson bought around 3k shares on-market at roughly €4.05 per share. In the last 3 months, there was an even bigger purchase from another insider worth €40k. Insiders have collectively bought €97k more in shares than they have sold in the last 12 months. Recent Insider Transactions • May 28
Independent Director recently bought €10k worth of stock On the 25th of May, Charlotte Hansson bought around 3k shares on-market at roughly €4.05 per share. In the last 3 months, there was an even bigger purchase from another insider worth €40k. Insiders have collectively bought €97k more in shares than they have sold in the last 12 months. Recent Insider Transactions • May 19
Independent Chairman of the Board recently bought €40k worth of stock On the 11th of May, James Noble bought around 10k shares on-market at roughly €4.26 per share. This was the largest purchase by an insider in the last 3 months. This was James' only on-market trade for the last 12 months. Reported Earnings • May 01
First quarter 2021 earnings released The company reported a poor first quarter result with weaker earnings, revenues and control over costs. First quarter 2021 results: Revenue: kr132.3m (down 24% from 1Q 2020). Net loss: kr31.5m (down 138% from profit in 1Q 2020). Reported Earnings • Mar 25
Full year 2020 earnings released: kr2.45 loss per share (vs kr6.33 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: kr663.6m (down 21% from FY 2019). Net loss: kr84.4m (down 139% from profit in FY 2019). Products in clinical trials Phase I: 2 Phase II: 2 Post-clinical trial products Pre-registration: 1 Is New 90 Day High Low • Mar 09
New 90-day low: €4.25 The company is down 4.0% from its price of €4.42 on 09 December 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €13.83 per share. Recent Insider Transactions • Feb 23
President & CEO recently bought €7.5k worth of stock On the 15th of February, Nikolaj Sørensen bought around 2k shares on-market at roughly €5.01 per share. This was the largest purchase by an insider in the last 3 months. Nikolaj has been a buyer over the last 12 months, purchasing a net total of €147k worth in shares. Announcement • Feb 10
Orexo Starts to Test modiaT on Patients in Collaboration with Apexb.Io and Magellan Rx Management Orexo AB (publ.) announced the company will collaborate with ApexB.io and Magellan Rx Management to further research on the use of modiaT, a digital therapeutic designed for individuals with opioid use disorder (OUD), by establishing a novel, real-world evidence approach. modiaT, offers individuals with OUD access to tailored, interactive psychotherapy interventions through their mobile device or computer. This relationship will provide further data behind the need for an easily accessible digital treatment option for OUD. This is a critical time for such a treatment option as the Centers for Disease Control and Prevention (CDC) recently called for expanded efforts related to the prevention of overdose deaths during the pandemic. The US has experienced more than 83,000 deaths as a result of overdoses, an increase of 21% which is the highest increase recorded ever in a 12-month period. Reported Earnings • Jan 30
Full year 2020 earnings released: kr2.45 loss per share (vs kr6.33 profit in FY 2019) The company reported a poor full year result with weaker earnings, revenues and control over costs. Full year 2020 results: Revenue: kr663.6m (down 21% from FY 2019). Net loss: kr84.4m (down 139% from profit in FY 2019). Products in clinical trials Phase I: 2 Phase II: 2 Analyst Estimate Surprise Post Earnings • Jan 30
Revenue beats expectations Revenue exceeded analyst estimates by 0.5%. Over the next year, revenue is expected to shrink by 4.6% compared to a 2.4% growth forecast for the Pharmaceuticals industry in Germany. Announcement • Jan 29
Orexo Strengthens IP Rights for Overdose Rescue Drug OX124 Orexo AB (publ) announced that the company has further strengthened the intellectual property (IP) for its pharmaceutical pipeline asset OX124, a naloxone rescue medication for the treatment of opioid overdose. The US Patent and Trademark Office (USPTO) has issued a new patent protecting the product until 2039. The new patent, US 10,898,480, is the second US patent for OX124. The first patent, US 10,653,690, was issued by the USPTO in the summer of 2020. At that time, the first patent for Orexo's nalmefene overdose rescue medicine, OX125, was also issued (US 10,729,687), as previously announced in the Interim Report for Q2, 2020. Both of these patents protect the respective products until 2039. Based on Orexo's innovative scalable intranasal formulation technology, OX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from synthetic opioids, such as fentanyl. In a previous human PK study of OX124 (OX124-001), all formulations of OX124 were found to be well tolerated and showed substantially higher plasma concentrations of naloxone, sustained duration of elevated plasma concentration, and equivalent or superior onset time when compared to the current market leading product. Is New 90 Day High Low • Jan 20
New 90-day high: €5.24 The company is up 7.0% from its price of €4.90 on 22 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 20% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €12.37 per share. Announcement • Dec 10
Orexo AB Enters into License and Supply Agreement with Accord Healthcare for ZUBSOLV Orexo AB has entered into licensing agreement with Accord Healthcare, for the commercialization of ZUBSOLV sublingual tablet. Licensed in Europe, ZUBSOLV is indicated for adults and adolescents over 15 years of age for substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment, and who have agreed to be treated for addiction. ZUBSOLV offers an alternative treatment option for patients as it launches across 29 countries in Europe. This agreement brings together the experience of Orexo in the opioid addiction market alongside the commercial reach of Accord Healthcare, who are partnering together with a common aim to ensure that people have more access to treatment options. There are estimated to be 1.3 million high-risk opioid users in Europe, yet treatment rates are low with around 50% of people with opioid dependence receiving some form of substitution treatment and this can vary greatly between countries. Under the terms of the agreement, Orexo will be responsible for product supply and Accord will take responsibility for the commercialization of ZUBSOLV. Orexo will receive double-digit royalties on future net sales. Analyst Estimate Surprise Post Earnings • Nov 05
Revenue misses expectations Revenue missed analyst estimates by 11%. Over the next year, revenue is expected to shrink by 5.1% compared to a 3.6% growth forecast for the Pharmaceuticals industry in Germany. Announcement • Nov 05
Orexo AB (Publ) Reaffirms Earnings Guidance for the Year of 2020 Orexo AB (publ) reaffirmed earnings guidance for the year of 2020. For the year, the company reduce guidance for 2020 to SEK 675-725 million from SEK 750-800 million and increase EBIT contribution margin guidance in US Pharma from 45-50% to exceeding 50%. 
