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Ascendis Pharma Conference Call Summary Company Overview - **Company**: Ascendis Pharma (NasdaqGS:ASND) - **Event**: Phase 2 Coach Trial Topline Week 52 Data Call - **Date**: January 08, 2026 Key Points Industry and Company Focus - **Industry**: Biotechnology, specifically focusing on treatments for achondroplasia and other growth disorders - **Core Product**: TransCon CNP and TransCon Growth Hormone Combination treatment Core Findings from the Coach Trial - **Trial Objective**: To evaluate the efficacy and safety of TransCon CNP combined with TransCon Growth Hormone in children with achondroplasia - **Patient Cohort**: 21 patients enrolled, including treatment-naive and treatment-experienced children [18][19] - **Primary Endpoint**: Annualized growth velocity at week 52, showing significant improvements [19][22] Efficacy Results - **Growth Velocity**: - Treatment-naive cohort: 8.8 cm/year, an increase of 3.9 cm/year from baseline [22][23] - Treatment-experienced cohort: 8.42 cm/year, an increase of 3.28 cm/year from baseline [24] - **Height Z-scores**: - Treatment-naive cohort: Increased from 0.46 to 1.47 [23] - Treatment-experienced cohort: Increased to 2.15 [24] - **Comparison to Historical Data**: Efficacy significantly exceeds historical benchmarks for achondroplasia treatments [6][7] Safety Profile - **Adverse Events**: 85% of adverse events were grade 1 (mild) and unrelated to the study drugs [21] - **No Cases of Symptomatic Hypotension**: Safety profile consistent with individual agents [21][22] - **Bone Age**: Remained consistent with chronological age, indicating no adverse effects on bone development [22] Additional Benefits - **Body Proportionality**: Improvements in upper to lower body segment ratios, indicating healthier bone growth [25][26] - **Arm Span Growth**: Statistically significant increase in arm span, reaching the 84th percentile compared to natural history in achondroplasia [27] Future Directions - **Phase 3 Trial Preparation**: Ongoing analysis of data to finalize the design of the phase 3 trial, focusing on both linear growth and additional benefits [30][41] - **Regulatory Submission**: TransCon CNP is under priority review with a PDUFA date of February 28, 2026 [52][81] Market Positioning and Pricing - **Combination Therapy**: Expected to be positioned as a leading treatment option for achondroplasia, addressing both growth and comorbidities [57][58] - **Pricing Strategy**: Anticipated to reflect the combined cost of both therapies, with considerations for global market variations [82] Conclusion - Ascendis Pharma is optimistic about the potential of TransCon CNP and TransCon Growth Hormone combination therapy to set a new standard in the treatment of achondroplasia, with significant efficacy and a favorable safety profile. The company is preparing for a phase 3 trial and is confident in the upcoming regulatory approval of TransCon CNP.

Phase 2 COACH Trial Topline Week 52 Data January 8, 2026 Treatment with TransCon CNP and TransCon hGH combination therapy is investigational. For investor communication only. Not for use in product promotion. Not for further distribution. Cautionary Note on Forward-Looking Statements This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, such as statements regarding TransCon hGH's ability to complement TransCon CNP's ho ...

Core Insights - Ascendis Pharma announced positive topline results from the Week 52 of the COACH trial, demonstrating that the combination therapy of once-weekly TransCon CNP and TransCon hGH showed durable growth without compromising safety or tolerability [2][3] Group 1: Trial Results - The combination therapy resulted in an annualized growth velocity (AGV) that exceeded the 97th percentile of average stature children [11] - For the treatment-naïve cohort, the mean AGV was 8.80 cm/year, with a mean ACH height Z-score improvement of +1.02, indicating a tripling of efficacy compared to TransCon CNP monotherapy [5][6] - The treated cohort showed a mean AGV of 8.42 cm/year, with an increase from baseline of 3.28 cm/year and a mean ACH height Z-score improvement of +0.86, increasing from 1.28 to 2.15 over 52 weeks [5][6] Group 2: Safety and Tolerability - The combination therapy was generally well tolerated, with mild treatment-emergent adverse events (TEAEs) consistent with those observed for the monotherapies [2][11] - Safety and tolerability profiles were consistent with TransCon CNP and TransCon hGH monotherapies, indicating a low incidence of injection site reactions [11] Group 3: Implications for Treatment - The results suggest that TransCon CNP may become a foundational therapy for achondroplasia, with TransCon hGH providing complementary benefits [2][3] - The trial highlights the potential for dual-agent regimens to set new standards of care in treating achondroplasia and other growth disorders [3][11] - Improvements in body proportionality and arm span were observed, aligning with the increase in linear growth, indicating benefits beyond just height [2][11] Group 4: Future Developments - Ascendis Pharma has submitted a protocol for a Phase 3 trial of TransCon CNP and TransCon hGH in pediatric achondroplasia and held an end of Phase 2 meeting with the FDA [7][11] - The U.S. FDA has granted Priority Review for TransCon CNP, with a PDUFA target action date of February 28, 2026 [3][11]

Core Insights - Ascendis Pharma A/S will participate in the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, providing a business update [1] - A live webcast of the presentation will be available on the Ascendis Pharma website, with a replay accessible for 30 days post-event [2] Company Overview - Ascendis Pharma is a global biopharmaceutical company focused on its innovative TransCon technology platform to develop new therapies addressing unmet medical needs [3] - The company is headquartered in Copenhagen, Denmark, with additional facilities in Europe and the United States [3]

Core Insights - Ascendis Pharma (ASND) is rumored to be a potential acquisition target in the near term, following strong earnings reported for Q3 2025 [1] Company Performance - The company reported robust Q3 2025 earnings in November, which contributed to the speculation surrounding its acquisition [1] Analyst Background - The analyst has a Master's degree in Cell Biology and extensive experience in drug discovery, which informs their investment analysis in the biotech sector [1] - The focus is on identifying innovative biotechnology companies with unique mechanisms of action and potential to reshape treatment paradigms [1] Investment Approach - The investment strategy emphasizes evaluating the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities while balancing financial fundamentals [1]

Core Insights - Warren Buffett has spent nearly $78 billion on stock repurchases since July 2018, indicating a strong belief in the intrinsic value of Berkshire Hathaway [1][21] - Buffett is set to retire at the end of the year after 60 years of leadership, during which he has achieved a cumulative return of almost 5,942,000% for Berkshire Hathaway's Class A shares [2] - Despite a historically expensive stock market, Buffett has been selective in his investments, focusing on companies with sustainable competitive advantages and strong capital-return programs [5][7] Investment Strategy - Buffett's investment philosophy emphasizes value; he only buys when he believes he is getting a good deal [5] - In recent years, Buffett has sold more stocks than he has purchased, totaling nearly $184 billion in net selling over the last 12 quarters [6] - Notable recent purchases include 17,846,142 Class A shares of Alphabet (GOOGL), reflecting confidence in the company's advertising and cloud services [9][10][11] Company Performance - Alphabet holds a dominant position in global internet search, capturing 89% to 93% of the market share, which enhances its advertising pricing power [10] - Google Cloud is expected to drive significant sales and cash flow growth, with an annual sales growth rate exceeding 30% [11] - Domino's Pizza has been a consistent investment for Buffett, with a focus on brand trust and transparency, alongside a strong growth strategy [13][14][15] Share Repurchase Activity - Berkshire Hathaway's board amended buyback rules in July 2018, allowing for unlimited repurchases if the company maintains at least $30 billion in cash and believes its stock is undervalued [19] - Between July 2018 and June 2024, Buffett has repurchased shares for 24 consecutive quarters, although there has been a 16-month period without any purchases due to high share premiums [21][22] - The share premium to book value has increased to between 60% and 80% during the period of inactivity, indicating a cautious approach to valuation [22] Long-term Confidence - Buffett has consistently expressed confidence in Berkshire Hathaway as a long-term investment, emphasizing the company's ability to thrive in various economic cycles [23][24]

Company Insights - Ascendis Pharma A/S's New Drug Application (NDA) for TransCon CNP has had its review period extended by the FDA, with the new target action date set for February 28, 2026, due to a major amendment submitted on November 5 [2] - Ascendis Pharma's stock rose by 0.8% to close at $207.12 on Monday [6] Industry Trends - The consumer discretionary sector is showing signs of optimism, with growth expectations for the next year, as indicated by the selection of iShares US Consumer Discretionary ETF by NB Private Wealth [3] - Monolithic Power Systems Inc reported better-than-expected third-quarter results, with earnings of $4.73 per share surpassing the consensus estimate of $4.64, and sales of $737.176 million exceeding the estimate of $722.252 million [5] - Monolithic Power's shares gained 2.1% to close at $983.58 on Monday [6] Analyst Ratings - Morgan Stanley analyst Terence Flynn maintained an Overweight rating on Vertex and raised the price target from $516 to $564 [4]

Group 1: Market Sentiment and Trends - Consumer discretionary sector is showing increased optimism due to growth expectations for the upcoming year [2] - Semiconductor equipment names, particularly Monolithic Power Systems (MPWR), have seen significant performance, with MPWR up over 60% in the last year [2] - The semiconductor index reached a record high, indicating strong outperformance of semiconductors compared to software [3] Group 2: Technical Movements - MPWR experienced a 3.5% increase today, attributed to technical factors and a general bounce in the semiconductor equipment sector [3] - GBIQ is selling calls against the NASDAQ, indicating a strategy to capitalize on market movements, with a 10.5% increase noted but only 30-50% coverage for further upside [2]

Group 1 - The biotech sector faces significant challenges in transitioning from continuous cash burn to operational profitability, which is a critical milestone for companies in this industry [1] - There is a strong interest in high-growth companies within sectors that are expected to experience exponential growth, highlighting the potential for substantial returns through innovation [1] Group 2 - The analysis emphasizes a combination of fundamental analysis and future trend prediction as essential tools for understanding and investing in disruptive technologies [1]