Core Insights - Karolinska Development AB is approaching a period where several portfolio companies will conclude their clinical studies, which is expected to yield exciting data readouts [1] Significant Events During the Third Quarter - Organon announced the discontinuation of the clinical development of drug candidate OG-6219 following phase 2 study results [4] - Modus Therapeutics completed patient enrollment for part 1 of its ongoing phase 2a study with sevuparin for chronic kidney disease with anemia [4] - Umecrine Cognition raised SEK 24.6 million through a convertible loan for its ongoing clinical study of golexanolone in Primary biliary cholangitis [4] - Modus Therapeutics raised SEK 28.3 million in a unit issue with a subscription rate of 189% to finance the development of sevuparin [4] - Umecrine Cognition presented data supporting golexanolone's mechanism in alleviating Parkinson's disease symptoms [4] - AnaCardio completed enrollment in the phase 2a study of drug candidate AC01 for heart failure, with results expected by year-end [4] - Dilafor was granted a US patent for tafoxiparin, which will support its phase 3 clinical development [4] - PharmNovo received approval to initiate a phase 2a clinical trial of PN6047 for neuropathic pain [4] - SVF Vaccines presented positive preclinical study results for SVF-001 targeting chronic hepatitis B and D [4] - Karolinska Development participated in BOOST Pharma's financing, contributing SEK 7.5 million to support phase 3 development of BT-101 for Osteogenesis imperfecta [4] - BOOST Pharma presented new long-term data from the BOOSTB4 trial for BT-101 at an international conference [4] - Modus Therapeutics received regulatory approval to initiate the second part of its phase 2 study with sevuparin [5] Financial Update - The net profit/loss for Q3 2025 was SEK -66.8 million, compared to SEK -10.9 million in Q3 2024 [8] - Earnings per share for Q3 2025 totaled SEK -0.25, down from SEK -0.04 in Q3 2024 [8] - The total fair value of the portfolio at the end of September 2025 was SEK 1,346.7 million, a decrease of SEK 38.2 million from the previous quarter [8] - Net asset value at the end of September 2025 was SEK 1,085.4 million, or SEK 4.0 per share, down from SEK 1,224.4 million or SEK 4.5 per share at the end of September 2024 [8] - Net sales for Q3 2025 totaled SEK 0.3 million, compared to SEK 0.4 million in Q3 2024 [8] - Karolinska Development invested SEK 28.4 million in portfolio companies during Q3 2025, up from SEK 19.8 million in Q3 2024 [8] - Cash and cash equivalents decreased by SEK 26.6 million, totaling SEK 44.5 million on September 30, 2025 [8]

Core Insights - Organon is divesting its JADA post-partum haemorrhage treatment system to Laborie Medical in a deal valued at up to $465 million, with $440 million received at closing and up to $25 million contingent on 2026 revenue targets [1][2] - The transaction is expected to be completed by Q1 2026, with around 100 Organon employees transferring to Laborie as part of the agreement [1] Financial Implications - The sale of JADA is part of Organon's strategy to improve its balance sheet capacity and focus on growth opportunities in women's health biopharma [3] - Organon inherited approximately $9.5 billion in debt when it spun off from MSD in 2021, with current debt reported at $8.9 billion as of Q2 2025 [3] Sales Performance - JADA's sales grew by 40% in 2024, reaching $61 million, but the company is shifting away from medtech women's health devices to concentrate on its biopharma range [4] - Nexplanon, Organon's leading biopharma product, generated around $179 million in revenue in Q2 2025 [4] Corporate Governance Issues - A sales malpractice issue involving Nexplanon led to the resignation of CEO Kevin Ali in October 2025, following a board investigation into improper wholesaler sales practices [5] - Following the malpractice revelations, Organon's stock value dropped by 20.9% from $9.16 to $7.25 within a few days, and the stock has decreased over 60% in the past year, from around $17-$18 in November 2024 to a current price of $6.61 [6]

The chief executive of Organon, the company behind the birth control implant product Nexplanon, has stepped down after an audit committee uncovered improper sales practices related to the medicine https://t.co/RigtHeKShR ...

Group 1 - ANI Pharmaceuticals is currently pausing in a flat base after retaking a closely watched moving average [1] - The company topped second-quarter earnings estimates by 28% according to IBD Stock Checkup [1] - ANI Pharmaceuticals is recognized as a leader in developing treatments for rare diseases [1] Group 2 - The stock has shown rising relative price performance but is still shy of key benchmarks [4] - ANI Pharmaceuticals has achieved a relative strength rating upgrade, hitting an 80-plus RS rating [4] - The stock is included in the IBD 50 Growth Stocks To Watch list [1]

Core Viewpoint - Fuhong Hanlin (02696) experienced a significant stock price increase following news of a hedge fund's stake increase and FDA approval for its biosimilar products [1] Group 1: Stock Performance - Fuhong Hanlin's stock rose over 6% in early trading, with a current increase of 5.09%, reaching HKD 79.45, with a trading volume of HKD 32.33 million [1] Group 2: Institutional Investment - Point72, a hedge fund managed by Steve Cohen, increased its holdings in Fuhong Hanlin by 243,800 shares at an average price of HKD 83.5703 per share, totaling approximately HKD 20.37 million [1] - Following this purchase, Point72's total shareholding in Fuhong Hanlin rose to 8.24 million shares, increasing its ownership percentage from 4.89% to 5.04% [1] Group 3: FDA Approval - Fuhong Hanlin announced that the U.S. FDA has approved the market applications for two biosimilar products: BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp) [1] - These products are biosimilars to PROLIA (denosumab) and XGEVA (denosumab) [1] - In 2022, Fuhong Hanlin entered into a licensing and supply agreement with Organon, granting Organon exclusive commercialization rights for several biosimilars, including BILDYOS and BILPREVDA, outside of China [1]

Summary of Karolinska Development Conference Call - September 01, 2025 Company Overview - **Company Name**: Karolinska Development - **Industry**: Investment in biotechnology and medical technology - **Founded**: 2003, publicly listed since 2011 - **Portfolio**: 11 companies focused on clinical phase innovations and medical technology [4][5][6] Core Insights and Arguments - **Investment Strategy**: Focus on finding and developing new companies, particularly those in clinical phases, often when other investors are not involved [4][5] - **Market Focus**: Emphasis on achieving cash flow positivity in the U.S. market for medical technology companies, with a revenue threshold of over 200 million SEK to attract buyers [5] - **Innovation Type**: Targeting "first in class" innovations, which are unique and carry higher risks but potentially offer greater rewards [5] - **Active Management**: The company takes an active role in its portfolio companies, assisting with capital raising and strategic direction [6] Portfolio Highlights - **Dilafor**: Currently in phase 3, previously had disagreements with the FDA regarding study endpoints, now resolved [7] - **Modus Therapeutics**: Focused on chronic kidney disease and malaria, with a significant need for treatments; phase 2 readout expected in 2026 [8] - **SVF-vaccin**: Aiming to develop a vaccine for hepatitis B and D, with a phase 1 study completed for COVID-19, but not pursuing further in that area [10] - **Anacardio**: A heart failure company with significant interest from big pharma; awaiting phase 2 results in November [12] - **Human Kind Cognition**: Focused on CNS diseases related to liver failure, with a shift to a different liver disease for exclusivity in the market [14][15] - **Boost Pharma**: Targeting osteogenesis imperfecta (brittle bone disease) with unique clinical data showing an 80% reduction in fractures [17][18] Financial and Market Dynamics - **Exit Strategy**: The company has made 12 exits, generating approximately 488 million SEK, with a long-term strategy focused on achieving cash flows from successful exits [20][21] - **Current Market Conditions**: The investment climate remains challenging, but there are signs of improvement; fundraising is competitive [22][23] - **Investment Opportunities**: Current pricing allows for entry into early-stage startups at lower costs, with a focus on helping these companies reach clinical milestones [34] Upcoming Developments - **Anacardio Phase 2 Data**: Expected in November, which could significantly impact the company's valuation [38] - **Yumikran Cognition**: Anticipated data on Parkinson's disease and a major study expected early next year [38] - **Boost Pharma**: Potential financing for a phase 3 study is anticipated [39] - **Modus Therapeutics**: Phase 2 data expected in 2026 [39] Additional Insights - **Investor Dynamics**: There is a mix of cooperation and competition among VC investors, with varying strategies on exits and funding [25][30] - **Clinical Challenges**: The company has faced setbacks, such as issues with capsule leakage in studies, but has resolved these [14][15] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction, portfolio developments, and market conditions affecting Karolinska Development.

Core Viewpoint - Karolinska Development AB emphasizes its clear strategy and stable scientific foundation for its investment portfolio, focusing on patient benefits amidst challenging market conditions [1]. Significant Events - Organon plans to discontinue the clinical development of drug candidate OG-6219, following Phase 2 study results [3]. - Umecrine Cognition presented preclinical data on golexanolone's effects on Parkinsonian symptoms at the AD/PD 2025 conference [4]. - Umecrine Cognition received a USD 420,000 research grant from The Michael J. Fox Foundation for golexanolone studies [4]. - OssDsign achieved a milestone of treating 10,000 patients with its bone graft product in the US market [4]. - Karolinska Development divested its remaining shares in OssDsign, resulting in a capital injection of approximately SEK 34.5 million [4]. Financial Update - The net profit/loss for Q2 2025 was SEK -73.3 million, compared to SEK -16.0 million in Q2 2024 [5]. - The total fair value of the portfolio decreased to SEK 1,384.9 million at the end of June 2025, down from SEK 1,434.2 million [5]. - Net asset value at the end of June 2025 was SEK 1,148.6 million, or SEK 4.3 per share, compared to SEK 1,238.2 million, or SEK 4.6 per share, at the end of June 2024 [5]. - Cash and cash equivalents increased by SEK 20.0 million, totaling SEK 71.1 million on June 30, 2025 [5].

Core Insights - Daré Bioscience announced positive interim results from its Phase 3 clinical trial for Ovaprene, a hormone-free intravaginal contraceptive, highlighting its potential as a first-in-category product [1][3][5] Clinical Trial Results - The independent Data Safety Monitoring Board recommended the continuation of the trial without modifications after a planned interim analysis [2] - Approximately 9% of participants experienced pregnancy, aligning with pre-pivotal study expectations, indicating Ovaprene's effectiveness [3] - No new safety concerns were reported, with 17% of participants discontinuing due to vaginal odor, the most common adverse event [4] Market Potential - The CEO emphasized the significant unmet need for effective, hormone-free contraceptives in the U.S., suggesting Ovaprene could transform the contraceptive landscape [5] - The ongoing trial aims to enroll about 250 participants, assessing the typical use pregnancy rate over 13 menstrual cycles [6] Commercialization and Financials - Bayer holds the option to obtain exclusive U.S. commercialization rights for Ovaprene upon completion of the pivotal trial, contingent on a $20 million payment [7] - Daré could receive up to $310 million in milestone payments and tiered royalties on net sales, subject to third-party agreements [7] Company Overview - Daré Bioscience focuses on innovative solutions in women's health, aiming to address unmet needs in areas such as contraception and sexual health [8] - The company has previously launched XACIATO™, a vaginal gel for bacterial vaginosis, and is developing other first-in-category candidates [9]

Portfolio Adjustment - The company sold Organon after it cut its dividend and the stock price declined [1][2] - The company bought VICI Properties, a triple net lease REIT specializing in gaming and casino properties [1][3][4] VICI Properties Investment Rationale - VICI Properties owns 93 properties, including 54 casinos such as the Venetian and Mandalay Bay, and 39 experiential properties [4] - VICI Properties has a strong management team [4] - VICI Properties offers a 53% dividend yield and an expected 3% FFO growth [5] - VICI Properties' rent escalators are tied to CPI, potentially benefiting from rising inflation [5] - VICI Properties' tenants (e g MGN and Caesars) ensure 100% occupancy and rent collection, even during the pandemic [6] - The investment in VICI Properties is expected to generate a 9-10% annualized return [7] - VICI Properties is considered a compelling investment in a lower growth environment [8]

Core Insights - Organon has decided to discontinue the clinical development of the drug candidate OG-6219 following the results of a Phase 2 clinical study that did not show improvement in endometriosis-related pain compared to placebo [1][2]. Company Overview - Karolinska Development AB is a Nordic life sciences investment company focused on identifying and developing breakthrough medical innovations in the Nordic region [5][6]. - The company has a portfolio of eleven companies targeting innovative treatments for serious diseases and is led by a team of investment professionals with a strong track record [7]. Financial Implications - Prior to the announcement, Karolinska Development estimated the risk-adjusted net present value (rNPV) of future cash flows from earn-out payments at SEK 76.2 million. The company recognizes the need for an impairment if Organon discontinues the project, with final impairment details to be presented in the interim report for Q2 2025 [4].