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2025 outlook remains amid FX headwinds & non-recurring effect Interim Report Q2 2025, July 16, 2025
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2 • This presentation, which is personal to the recipient, has been prepared and produced by Orexo AB (publ) (“Orexo”) solely for the benefit of investment analysis and may not be used for any purpose other than assessment of investments concerning Orexo. Unless otherwise stated, Orexo is the source for all data contained in this presentation. Such data is provided as at the date of this presentation and is subject to change without notice. • This presentation does not constitute or form part of, and should not be construed as, an offer or invitation for the sale ofor the subscription of, or a solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it or the fact of its distribution form the basis of, or be relied on in connection with, any offer, contract, commitment or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of Orexo • The shares of Orexo have not been registered under the U.S. Securities Act of 1933, as amended (the “Securities Act"), and may not be offered or sold in the United States (as such term is defined in Regulation S under the Securities Act) except pursuant to an exemption from, or a transaction not subject to, the registration requirements of the Securities Act or unless registered under the Securities Act. • The information in this presentation has not been independently verified. No representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy or completeness of the information or opinions contained herein. None of Orexo, any of its shareholders, or any of their respective subsidiary undertakings or affiliates or any of such person’s directors, officers or employees, advisers or other representatives, accepts any liability whatsoever (whether in negligence or otherwise) arising, directly or indirectly, from the use of this presentation or otherwise arising in connection therewith. • This presentation includes forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance, achievements or industry results to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this presentation and Orexo expressly disclaim any obligation or undertaking to release any update of, or revisions to, any forward-looking statements in this presentation as a result of any change in our expectations or any change in events, conditions or circumstances on which these forward-looking statements are based. • This presentation is not a prospectus in accordance with the Swedish Financial Instruments Trading Act (Sw. lagen (1991:981) om handel med finansiella instrument) or any other Swedish laws or regulations. Neither the Swedish Financial Supervisory Authority (Sw. Finansinspektionen) nor any other Swedish regulatory body has examined, approved or registered this presentation. Legal disclaimer
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3 Q2 2025 PRESENTATION Nikolaj Sørensen President and CEO Fredrik Järrsten EVP and Chief Financial Officer 1 Q2 in brief 2 Business update • US Commercial • Products under Development 3 Financial & legal overview • Financial development • Legal update 4 Future value drivers Agenda & presenters 3
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The quarter in brief 4Q2 2025 PRESENTATION
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5 FX headwind (SEK 12 m impact on net sales) and non-recurring rebate payment (SEK 9 m) resulted in negative EBITDA Zubsolv® revenue grows QoQ in USD when excluding non- recurring rebate. Increasing profit contributions from US business Cash flow of SEK 4 m in Q2 and cash position improved from SEK 119 m to SEK 121 m OX124, components to nasal device delivered late Q2 enabling initiation of commercial testing in preparation for resubmission OX640 final formulation decided and upscaling of manufacturing to commercial scale initiated in parallel with partner discussions Outlook for 2025 re-affirmed. 118 Net revenues 78 ZUBSOLV® EBIT 121 Cash SEK M -10 Group EBITDA SEK M 2025 outlook remains amid FX headwinds and non-recurring rebate payments SEK M Q2 2025 PRESENTATION
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Geopolitical factors and US domestic politics continue to be unpredictable FX fluctuations • Approx. 80% of exchange rate impact on top line mitigated on EBIT from significant share of expenses in USD • Some impact on financials due to cash balance in USD and interest payment on corporate bond in SEK . • No impact on Zubsolv. Zubsolv is manufactured in the US for the US market and Zubsolv for Europe will soon be manufactured in Europe • AmorphOX® pipeline primarily rely on manufacturing in Canada and could long term be impacted by tariffs to the US market. FX impact on EBIT reduced due to natural hedge Tariffs 6 Q2 2025 PRESENTATION • Medicaid is the largest payer in the OUD space and reductions in Medicaid programs could impact overall volumes • Rebates in Medicaid are high and EBIT impact will be mitigated if patients convert to a commercial insurance • Changes in Medicaid will be implemented over time and impact 2025-2026 most likely limited. Medicaid financing
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7 Business update US Commercial 7 Q2 2025 PRESENTATION
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8 Buprenorphine/naloxone market development1 Q2 YoY +4% Q2 QoQ +2% Improved growth in the bup/nal market Market development by payer segment YoY • Medicaid segment growth stagnating at +1% following Medicaid disenrollment • Commercial segment growth of +11% as patients switched from Medicaid • Decline in Cash segment of -11%. Zubsolv® development • QoQ: flat development, driven by growth in Medicaid and maintained volume in Commercial. UHG & Humana impacted negatively. • YoY: -6%, mainly explained by lower volume at UHG and Humana Medicare D (new rebate system). Medicaid & Commercial showed flat development. 1 Based on IQVIA prescription data and include both retail and non-retail volumes. Note weekly prescription data is volatile and is influenced by public holidays, weather and changes to reimbursement. NTRx 0 1 000 000 2 000 000 3 000 000 4 000 000 5 000 000 6 000 000 Q2 2025 PRESENTATION
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Protecting Zubsolv USD revenue and EBIT Contribution Continued optimization of Zubsolv business • Selling and Admin expenses in US commercial have declined 27 percent from Q2 last year as a result of continued cost optimization and to some extent FX • EBIT margin increase to 39 percent when excluding rebate payment (24%, Q2 2024) • Slight growth QoQ from demand in open plans, driven by good growth in large Medicaid states and growth in Commercial when excluding UHG • Slight acceleration in market growth • Significant funding available from the opioid settlements, which could fill a potential gap following lower volume in Medicaid • If Medicaid decline results in growth in Commercial segment, the higher profitability in Commercial can mitigate the decline in volume with increased price • Unmet medical need for treatment remain significant, although number people dying from overdose has declined Market growth expected to continue despite changes in Medicaid 9 Q2 2025 PRESENTATION Zubsolv 2025 guidance reiterated • Expected overall market growth of 2-5% • Net sales of USD 50-55 m (USD 53) incl. price increase of 4%, Jan. 1 • Main uncertainty is Medicare development and unexpected changes in market access mid-year.
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10 10 Business update Products under development Q2 2025 PRESENTATION
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11 Device components for IZIPRY (OX124) delivered Long term plan to move to next generation of nasal device to reduce supply risk • Main difference is to the handling of the product, not to the critical parts of the device i.e. nozzle and compartment for the powder. • Orexo has initiated the process to complete the FDA required testing with expected filing mid-2026 • Stability data is the main driver of the timeline and Orexo has to balance time-to-market, shelf life at launch and risk of approval. - a scalable drug delivery platformSupply of critical component received late Q2 11 Q2 2025 PRESENTATION IZIPRY is based on AmorphOX ® and designed to treat overdoses caused by synthetic opioids, such as fentanyl and fentanyl analogues. Final approval and timeline is subject to FDA assessment of data supplied and need for stability data IZIPRY trade name conditionally approved by FDA • Pronounced “Eye-ZIP-ree” • Final approval subject to FDA approval of the product.
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12 • Existing manufacturing capacity capable to launch and ramp up global OX640 distribution • Full commercial manufacturing lines are set up and qualified awaiting FDA approval (as part of Izipry NDA). FDA has inspected the facility with good result. • Orexo has the only commercial manufacturing line to produce dry powder epinephrine using the only commercial available nasal powder device • Additional capacity is currently under construction • Ready for commercial use in H1 2026 Positioned to improve COGS Ensure capacity to meet significant global demand of OX640, Izipry and other amorphOX based nasal products. OX640: Manufacturing is ready for upscaling and meet significant global demand Q2 2025 PRESENTATION
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13 OX640: Partnering discussions ongoing OX640 – upscale to commercial manufacturing initiated Leveraging existing Izipry supply chain, from powder manufacturing to fully automated filling and packaging process 13 Q2 2025 PRESENTATION Partnering discussions ongoing in parallel with upscaling Both global and regional potential partners have shown interest in OX640 Selection based on capabilities in the relevant sector, shared view on potential of OX640 and financial terms POTENTIAL DIFFERENTIATING PROPERTIES -superior absorption and exposure -longer shelf life -less restrictive storage requirements -improved dose conformity -preservative free. Dose & formulation Manufacture clinical trial material Stability, reliability, process verification studies Clinical trials Tech transfer Today
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• Until 2015 Opioid overdose rescue medication was pre-filled syringes or a non-FDA approved nasal application on a pre-filled syringe • Use and availability limited by difficulty to carry syringes, hesitance to use by bystanders and highly varying quality • In 2015 the first liquid FDA approved nasal formulation, Narcan®, was launched by the Adapt Pharma • In Q4, 2016 Narcan became the market leader, through significant growth of the retail market (400%) and substitution of pre-filled syringes • Today >90% of the market is nasal spray in the US 14 OX640: Narcan transformed the opioid rescue market – a good analogue for intranasal epinephrine After a slow start in 2015 with sales USD <5 m, net sales started to build and peaking in Q3 2021 with USD >130 m in net sales 133 Source: Company financial reports, Orexo internal information Q4Q3Q2Q1 Q3 20212016 $ Million Net Sales Q2 2025 PRESENTATION >10x 14
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15 AmorphOX®: Spray-dried powder technology Cost-efficient powder formulation technology that is applicable for a wide range of (sensitive) APIs to allow for various dosage forms and administration routes. Orexo owns all rights to the technology and supports your efforts with a highly experienced and knowledgeable team. 01. Precise particle size engineering 02. Powerful stability features 03. Validated in humans Drug Carrier materials Optionally, other excipients such as permeability enhancer Ideal for the development of rescue products due to rapid absorption in the nasal cavity Stabilizes sensitive APIs like epinephrine both physically and chemically Successfully tested with 3 different APIs in 5 in-human clinical studies 04. Strong IP Protection 4 granted US/EP patents and patent applications protecting OX640 up until 2044 Q2 2025 PRESENTATION
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AmorphOX® strategy focuses on large molecules and rescue medications Advance internal rescue medication projects Izipry® (OX124) for opioid overdose OX640 for anaphylaxis OX390 for overdoses with an illicit drug OX125 for opioid overdose (on hold) Expand into large molecules Abera Bioscience collaboration Data from several other partnerships including SOBI and other non-disclosed Generate additional data from specific large molecules Partner to expand reach and de- risk Establish partnership with contract development and manufacturers to expand reach 16 Q2 2025 PRESENTATION AmorphOX value propositions Powder-based formulations offer improved stability Higher drug load and local drug concentration Rapid and extensive systemic drug absorption Improved drug deposition Ideal as non-invasive rescue medication Convenient and needle-free Preservative-free
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17 Financial & legal Q2 2025 PRESENTATION 17
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18 Zubsolv® net revenue in Q2 affected by FX impact and non-recurring rebate Zubsolv US Net revenue declined YoY with SEK 34 m primarily due to lower demand, a negative FX impact of SEK 12.3 m and non-recurring payer rebate payment with negative impact of SEK 8.9 m partly offset by higher wholesaler stocking In local currency Zubsolv revenue grew QoQ by 2.0% excluding the non-recurring rebate payment impact. Lower Abstral ROW royalties accrued based on lower expected sales Higher Edluar royalties due to higher revenues in EU Lower Zubsolv ex-US revenues are explained by absence of tablets sales to Orexo’s partner Accord Healthcare in anticipation of start of manufacturing in Europe Comments Q2Net revenue per segment SEK m Q2 2025 Q2 2024 H1 2025 H1 2024 Jan - Dec 2024 Zubsolv® US 113.5 147.9 246.5 277.2 560.3 Digital Mental Health Programs (DMHP) - 0.0 0.0 0.0 0.0 US Commercial – Total 113.5 147.9 246.5 277.2 560.3 Abstral® royalties 0.7 1.3 2.4 8.4 8.2 Edluar® royalties 3.6 3.3 7.0 6.0 12.5 Zubsolv® – ex US 0.4 1.5 8.5 1.7 8.9 HQ & Pipeline – Total 4.8 6.0 17.9 16.1 29.7 TOTAL 118.2 154.0 264.5 293.2 590.0 Q2 2025 PRESENTATION 133,0 123,4 113,5 Q1 2025 Open1 Non-reimbursed1 UHG & Humana1 Stocking Net Price/Mix/GTN Currency Q2 2025 w/o non-recurring adjustment Adjustments Q2 2025 with non-recurring adjustment -14,7% Zubsolv US net revenue Q225 vs Q125 1Estimated change in demand by segment, based on Net Sales development during the quarter , IQVIA demand data, institutional sales and claims data from insurance companies • +1.7% in demand in open segment • -0.8% in demand in Non-reimbursed • -0.5% in demand in UHG & Humana • Higher wholesaler inventory stocking of SEK 7.1 million • Unfavorable Payer mix and negative GTN • Negative FX impact of SEK 12.3 million : USD/SEK AVG: • Q1/25: 10.68 • Q2/25: 9.64 -5.5% decline in local currency 2.0% growth in local currency w/o non-recurring payer rebate impact • Non-recurring payer rebate, negative impact SEK 8.9 million -7.2%
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19 Income statement SEK m Q2 2025 Q2 2024 H1 2025 H1 2024 Jan - Dec 2024 Net revenues 118.2 154.0 264.5 293.2 590.0 Cost of goods sold (COGS) -8.4 -16.3 -29.2 -29.6 -72.1 Gross Profit 109.8 137.7 235.3 263.7 517.9 Operating Costs -131.4 -153.5 262.0 -284.2 -658.2 EBIT -21.5 -15.8 -26.7 -20.5 -140.3 Net financial items -12.3 -21.5 -26.4 -26.6 -50.3 EBT -33.8 -37.3 -53.0 -47.1 -190.6 Tax -5.9 1.4 -2.6 2.3 -12.4 Net profit/loss -39.8 -35.9 -55.6 -44.8 -203.0 EBITDA -10.1 5.0 -4.2 20.9 48.9 OPEX lower YoY considering mainly: • Lower selling expenses due to timing of activities for OX124 (pre-launch in Q2 last year) and lower GPO fees and exchange rates • Lower administrative expenses due to lower legal costs • Lower R&D costs driven by lower amortization costs for DMHP and Zubsolv intangible assets partly offset by higher costs for OX124 • Offset by negative FX effect on revaluations of balance sheet items US Commercial EBIT contribution of SEK 35.5 m (36.0) • Including non-recurring rebate payment negative impact of SEK 8.9 m • EBIT Margin for the quarter 31.3% (24.4%) and 39.1% excluding rebate payment EBIT of SEK -21.5 m (-15.8) EBITDA of SEK -10.1 m (5.0) NET FINANCIAL ITEMS of SEK -12.3 m (-21.5) • Lower bond loan costs of SEK -12.0 m (-21.4) due to lower interest expense for the new corporate bond loan and absence of bond renewal related costs vs Q2 2024 Comments Q2 Total operating expenses 14.4% lower than Q2 last year Q2 2025 PRESENTATION
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20 Cash Flow SEK m Q2 2025 Q2 2024 H1 2025 H1 2024 Jan - Dec 2024 Cash flow from operating activities -0.7 -6.5 32.1 -25.4 -32.6 Investment activities 0.0 -2.7 -19.2 -3.8 -5.3 Financing activities 4.5 -48.0 -2.5 -4.7 -15.5 Cash flow (excl. exchange rate differences) 3.7 -57.1 10.4 -34.0 -53.5 Exchange-rate differences in cash and cash equivalents -1.5 -1.2 -12.4 2.6 5.8 Cash and cash equivalents at the beginning of the period 119.1 198.0 123.3 171.0 171.0 Cash and cash equivalents at the end of period 121.3 139.7 121.3 139.7 123.3 Net cash position -350.3 -318.8 -350.3 -318.8 -336.8 Cash and cash equivalents (SEK 121 m) increased with SEK 2 m from Q1 2025 (SEK 119 m) SEK 0.7 m negative contribution from operating activities primarily impacted by: Operating earnings of SEK -21.5 m Interest and other financial expenses paid of SEK -12.5 m for the refinanced bond loan - SEK 11.1 m lower compared to last year Timing of provisions i.e. payer rebates and returns - positive effect of SEK +4.2 m for the quarter Negative changes in working capital of SEK -0.4 m negatively impacted primarily by changes in inventories, SEK -10.9 m and receivables SEK -19.0 m. positively impacted by changes in current liabilities, SEK +29.4 m SEK +3.7 m in Total cash flow for the period also impacted by SEK +10.0 m from sale of Orexo’s own bond SEK 10 m partly offset by amortization of lease liability SEK -5.5 m SEK +2.2 m increase in cash position following a negative SEK -1.5 m FX effect Comments Q2 Positive cash flow (excl. exchange rate differences) SEK +3.7 m Q2 2025 PRESENTATION
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21 Financial outlook 2025 Key market development The buprenorphine/naloxone market will grow 2-5 percent, based on current growth trajectory Reaffirmed Lead product net sales Zubsolv® net sales in USD in the range of USD 50-55 m Reaffirmed Group OPEX Opex excluding depreciation and amortization in the range of SEK 460-500 m Reaffirmed Group EBITDA Positive EBITDA for the FY 2025 Reaffirmed Metric Outlook 2025 Reaffirmed/ revised Q2 2025 PRESENTATION The financial outlook 2025 is based on a forward-looking assumption of a USD/SEK exchange rate of 10.501. The average USD/SEK exchange rate during Q2 was 9.64 and 9.49 in the end of the quarter. 1) In a currency sensitivity analysis the negative impact on US Commercial net sales from a weaker USD will be dampened at the EBIT level due to a positive natural hedge on the cost side covering about 80 percent of that reduced net sales.
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Q2 2025 PRESENTATION 22 Legal update On July 14, 2020, Orexo became aware of an investigation by the US authorities which is ongoing Based on communications from the US authorities, the company believes it refers to certain historic marketing messaging campaigns Orexo, as of this date, is not aware of any filed civil or criminal case related to the investigation Orexo’s position to the government has been that its investigation concerns have no merit, but Orexo is also seeking to negotiate a resolutions to this matter Change in administration may slow down process due to US process of politically appointed US prosecutors. Subpoena issued by the US authorities US government agency investigation related to ZUBSOLV®
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23 Future value drivers Q2 2025 PRESENTATION
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Maintain Zubsolv® revenue streams in USD Obtain FDA approval and initiate US launch of OX124 Achieve milestones and receive royalties from existing and upcoming partnered products. Advance internal rescue medications and out-license products based on the AmorphOX technology such as OX640 Expand into large molecules through partnership and improve scientific proof of concept Partner with CDMO and other partners to expand reach of technology. Approach for expansion 24 Responsible business Access to healthcare Environment & climate change Sustainable employees Growing revenues & profit contributions Capitalising the AmorphOX® technology Improving access to treatment Expand reimbursement of Zubsolv in the public payer segment and maintain access in the commercial payer segment Secure reimbursement for OX124 US launch. ESG Q2 2025 PRESENTATION
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25 Thanks www.orexo.com You can also follow Orexo on LinkedIn, X and YouTube.