Zetomipzomib in Autoimmune Hepatitis (AIH) - The PORTOLA Phase 2 study evaluated zetomipzomib in AIH patients with relapsed disease or inadequate response to prior therapy [16] - In a pre-specified subgroup of patients on steroid-based therapy (n=21), 36% (5/14) of zetomipzomib-treated patients achieved a steroid-sparing complete biochemical remission (CR) by Week 24, compared to 0% (0/7) in the placebo arm [18] - In the Intent to Treat (ITT) population (n=24), 31.3% (5/16) of zetomipzomib-treated patients achieved a steroid-sparing CR by Week 24 versus 12.5% (1/8) in the placebo arm [18] - The PORTOLA results support a registrational program in AIH, a disease affecting approximately 100,000 patients in the US [17, 21] - The company plans to present PORTOLA results at a major medical conference in the second half of 2025 [43] Zetomipzomib in Lupus Nephritis (LN) - In the MISSION Phase 2 study, 35% of LN patients achieved a complete renal response (CRR) following 25 weeks of treatment without induction therapy [48, 50] - In the PALIZADE Phase 2 study, over 40% of patients achieved a UPCR ≤0.5 at Week 25 in the 60 mg zetomipzomib dose group [48] - The MISSION Phase 2 study showed an 83% median reduction in UPCR from baseline to Week 29 (4 weeks post-EOT) [50] - In the PALIZADE trial, the median percent change in UPCR from baseline at Week 25 was -67% in the Zetomipzomib 60mg group [54] Safety and Tolerability - In the PORTOLA study, the most common treatment emergent adverse events (TEAEs) were injection site reactions (ISRs) and systemic injection reactions (SIRs), all of which were Grade 1 or Grade 2 [18]

Financial Performance & Goals - In fiscal year 2021, The Toro Company (TTC) achieved net sales of $3.96 billion[19] - The company aims to exceed $5 billion in net sales by the end of fiscal year 2024 through organic growth[60] - The company also aims to exceed $750 million in annual adjusted operating earnings by the end of fiscal year 2024[60] - For the second quarter of fiscal year 2022, net sales reached $1.25 billion, an increase of 8.7% compared to the same period in fiscal year 2021[71] - For the first six months of fiscal year 2022, net sales were $2.182 billion, a 7.9% increase year-over-year[72] - The company anticipates net sales growth of 14% to 16% for fiscal year 2022[76] Segment Breakdown (Fiscal Year 2021) - Professional segment accounted for 74% of net sales, totaling $2.93 billion, with segment earnings at 17.3%[20] - Residential segment accounted for 26% of net sales, totaling $1.01 billion, with segment earnings at 12.0%[20] - In terms of geographic market, 79% of sales were from the United States, and 21% were international[20] Capital Allocation & Returns - The company targets a gross debt-to-EBITDA ratio of 1-2x[80] - The company's return on average invested capital for fiscal year 2021 was 20.8%[86] - The company's return on average equity for fiscal year 2021 was 32.7%[86]

Pipeline Programs - LP-10 (Liposomal tacrolimus) is positioned for market exclusivity in treating Hemorrhagic cystitis (HC), with a well-established mechanism and demonstrated safety in Phase 2a studies[11] - LP-310, an oral rinse formulation of LP-10, targets the Oral Lichen Planus (OLP) market, estimated at USD 980 million in 2028 and projected to reach USD 2.7 billion by 2034[14] - LP-410, an alternative oral rinse formulation of LP-10, is intended for the treatment of oral Graft-Versus-Host Disease (GVHD) and has received FDA Orphan Disease Designation[70] - LP-50 is an intravesical liposomal formulation of checkpoint Inhibitor for the treatment of bladder cancer[74] LP-310 Clinical Trial Results and Market Opportunity - Phase 2a multicenter dose escalation study completion of LP-310 for Oral Lichen Planus is anticipated in 2Q25[15] - LP-310 Phase 2a data shows safety with minimal systemic uptake and statistically significant improvement of efficacy[50] - Oral Lichen Planus (OLP) affects approximately 6 million Americans, presenting a substantial target market with no current FDA-approved pharmacotherapy[14, 19, 53, 86] - Projected annual revenue per customer for LP-310 is $8,000[53] LP-10 Market and Revenue Potential - Hemorrhagic cystitis affects approximately 60,000 individuals annually[13] - The company anticipates annual revenue of $20,000 per patient for LP-10 intravesical instillation[13, 91, 92] - Market penetration of 60,000 patients (45%) for LP-10 could yield $1.2 billion in annual revenue[13, 91, 92]

Corporate Overview - RedHill Biopharma is an emerging U S specialty biopharmaceutical company focused on gastrointestinal, infectious diseases, and oncology[9] - The company has a streamlined U S commercial organization and a robust development pipeline with multiple near-term milestones[9] - As of December 31, 2024, RedHill Biopharma had a cash balance of $4 8 million[18] - For FY24, RedHill Biopharma reported net revenues of $8 0 million and a gross margin of 60 3%[9, 18] - The company's market capitalization is approximately $4 4 million[18] Talicia® - Talicia® is the No 1 branded U S Rx for H pylori and is listed as a first-line option in the ACG guideline[9, 28, 44] - In a Phase 3 study, Talicia® demonstrated 84% eradication of H pylori in the ITT population versus 58% with the active comparator (p<0 0001)[59] - In the confirmed adherent population, Talicia® achieved a 90% eradication rate compared to 65% with the active comparator (p<0 0001)[59] - Talicia® has broad U S managed care coverage, covering 7 out of 10 commercial lives and 6 out of 10 government lives[48] Pipeline Products - Opaganib is under U S Government collaboration for evaluation as a potential medical countermeasure for GI-ARS[12, 75] - RHB-102 has positive results from a first Phase 3 U S study for Gastroenteritis[12] - RHB-104 has positive results from the first Phase 3 "MAP US" study for Crohn's disease[12]

Investment Highlights - The company is focused on a rare and orphan disease product pipeline[9] - The company is on track for First Netherton Syndrome Treatment Approval in 2026[9] - The global Netherton commercial opportunity is in excess of $1 billion[9] Product Pipeline - QRX003 is in pivotal clinical studies for Netherton Syndrome[12] - Clinical trial has been initiated for QRX003 for Peeling Skin Syndrome[12] - Clinical testing for QRX003 for Palmoplantar Keratoderma is expected to commence in the second half of 2025[12] Netherton Syndrome (NS) and QRX003 - Netherton Syndrome affects 6,000 – 8,000 newborns in the US and Europe combined, with up to 30,000 in Quoin Partnered Territories[21] - QRX003 is a topical lotion to be applied twice-daily to whole body surface[26] - Pilot study data showed marked improvements across all measured clinical endpoints with QRX003[31] - Pediatric whole body data showed that one patient experienced zero nightly sleep disturbances for the first time in her life after treatment with QRX003[40] Additional Rare Skin Disorders - Clinical testing in PPK to commence in 2025[50] - First Subject Peeling Skin Data showed the M-IASI decreased from 36 to 12 after 12 weeks[52]

Financial Performance & Growth - 2021年，Crocs 收入达到 23 亿美元，同比增长 67%，相对比2019年增长 88%[14]，调整后的营业利润率达到 30%[11,14] - Crocs 预计到 2026 年收入将达到 60 亿美元以上[11,74] - 2021年，数字化销售额同比增长 48%，相对比2019年增长 122%，占总销售额的 37%[14] - 第四季度，Crocs 收入为 5.87 亿美元，同比增长 43%[26]，调整后的营业利润率从 21% 增长到 29%[26] HEYDUDE Acquisition - Crocs 于 2022 年 2 月 17 日完成了对 HEYDUDE 的收购[53] - Crocs 预计 HEYDUDE 将在 2024 年成为一个超过 10 亿美元的品牌[56,57] - Crocs 预计 HEYDUDE 在收购后的 2022 年收入为 6.2 亿至 6.7 亿美元，如果包括收购前的时间，预计 HEYDUDE 2022 年的收入约为 7 亿至 7.5 亿美元[70,71] 2022 Outlook - Crocs 预计 2022 财年的收入约为 34 亿美元，同比增长 20% 以上[70] - Crocs 预计 2022 年调整后的营业利润率约为 26%[70] - Crocs 预计 2022 年调整后的摊薄后每股收益为 9.70 美元至 10.25 美元[70]

AVTX-009 and HS Market - AVTX-009, an anti-IL-1β mAb, is a lead compound with potential for best-in-class and best-in-disease profile in hidradenitis suppurativa (HS)[7] - The HS market is expected to grow to over $10 billion by 2035[8] - Avalo is enrolling patients in a Phase 2 LOTUS trial for HS, with topline data expected in mid-2026[8] - AVTX-009 has 15x higher affinity than lutikizumab, potentially predictive of higher efficacy and less frequent dosing[10] Financials and Strategy - Avalo expects its cash runway to extend into 2028[8] - As of March 31, 2025, Avalo had approximately $125 million in cash[70] - As of March 31, 2025, Avalo's adjusted market capitalization was $284.5 million, based on an adjusted common share count of 35.5 million and a stock price of $8.01[70] IL-1β and AVTX-009 Advantages - IL-1β gene expression is up to 100x increased in HS lesions compared to healthy skin[26] - AVTX-009 is designed to target the inflammatory driver of Hidradenitis Suppurativa (HS) to address significant unmet need[15] - AVTX-009 has a subcutaneous bioavailability of 73% and a half-life of 19 days[35]

TH104 - Opioid Overdose Prophylaxis - TH104 is a first-in-class buccal film delivery of nalmefene for military use and is NDA fileable[6, 84] - The FDA has confirmed that no additional clinical trials will be required prior to NDA submission for TH104 for its initial indication[7] - Current naloxone autoinjector provides approximately 2-hour protection versus 7-hour fentanyl exposure, necessitating frequent re-dosing[17] - Government acquired 788,000 Kaléo autoinjector units, indicating growing demand for synthetic opioid countermeasures[46] - At 24-hours, Groups A & B in Phase 1 Chronic Liver Disease (CLD) Study had mean declines of 30.7% & 35.2%, respectively in pruritus scores[106] TH023 - Oral Anti-TNFα for Autoimmune Diseases - TH023 is an oral anti-TNFα monoclonal antibody targeting autoimmune diseases and is Phase 1-ready[6, 84] - The oral anti-TNFα market opportunity has the potential to disrupt the $50B+ global autoimmune biologics market[6, 84] - The existing market size generated annually by TNFα inhibitors (e.g., Humira, Remicade) is approximately $47B[58] Strategic & Financial - The company anticipates a clear pathway to NDA submission for TH104 within 12 months of CMC initiation[34] - The global PBC treatment market is valued at approximately $2.5B and is expected to grow[96]

Financial Performance & Growth - Catalyst Pharmaceuticals experienced a 43.6% increase in total net product revenue in 1Q25 compared to 1Q24[55] - The company's 1Q25 net product revenues reached $141.4 million, up from $98.4 million in 1Q24[61] - Net income (GAAP) for 1Q25 was $56.7 million, significantly higher than the $23.3 million reported in 1Q24[61] - Catalyst forecasts total revenues between $545 million and $565 million for the full year 2025[60] Product Portfolio - FIRDAPSE revenue for 1Q25 was $83.7 million, compared to $66.8 million in 1Q24[56] - AGAMREE revenue for 1Q25 was $30.4 million[56] - FYCOMPA revenue for 1Q25 was $35.6 million, compared to $22.0 million in 1Q24[56] - FIRDAPSE is projected to generate between $355 million and $360 million in revenue for 2025[60] - AGAMREE is projected to generate between $100 million and $110 million in revenue for 2025[60] - FYCOMPA is projected to generate between $90 million and $95 million in revenue for 2025[60] Market & Strategic Focus - The total addressable market for the LEMS population is estimated to be over $1 billion[29] - The total addressable market for the DMD population is estimated to be over $1 billion[39]

MOLBREEVI for aPAP - MOLBREEVI demonstrated statistically significant improvement in DLCO% (primary endpoint) at Week 24 (p=0.0007) and Week 48 (p=0.0008) compared to placebo[37] - MOLBREEVI showed nominally significant improvement in Exercise Capacity (Peak METs) at Week 48 (p=0.0234) compared to placebo[37] - MOLBREEVI significantly reduced pulmonary surfactant burden, as shown by Ground Glass Opacity (GGO) score at Week 24 (p=0.0004)[66] - 100% of patients who completed the double-blind period enrolled into the open-label period[37] - The treatment discontinuation rate in the double-blind period was low at 3%, with none due to drug-related adverse events[37] aPAP Disease and Market - Autoimmune PAP (aPAP) is a rare lung disease with no approved drugs in the U S or Europe, and the only treatment option is an invasive procedure[15] - Analysis of U S claims data identified approximately 3,600 aPAP patients[108] - Market development team of ~25 people will be responsible for profiling accounts to gain line of sight into currently diagnosed patients[117] - U S pulmonologists show overwhelming support for MOLBREEVI, with 83% likely to prescribe it regardless of disease severity[113] - The potential U S market opportunity for aPAP is estimated to be >$1 billion[135] Regulatory and Financial - Savara plans to resubmit the BLA for MOLBREEVI in Q4 2025[31] - The company has ~$172.5 million in cash and short-term investments as of March 31, 2025, and non-dilutive debt financing for up to $200 million[133]