Rhythm Pharmaceuticals, Inc. · NASDAQ:RYTM
Rhythm Pharmaceuticals — Q3 2023 Earnings Presentation
28 slides from Rhythm Pharmaceuticals's earnings presentation, Nov 15, 2023
Slide 1: Third Quarter 2023 Financial Results and Business Update
Rhythm Pharmaceuticals Third Quarter 2023 Financial Results and Business Update November 7, 2023 ® © Rhythm® Pharmaceuticals, Inc. All rights reserved.
Slide 2: On Today's Call
On Today’s Call David Connolly, Executive Director of Investor Relations and Corporate Communications David Meeker, MD, Chair, President and Chief Executive Officer Jennifer Chien, Executive Vice President, Head of North America Yann Mazabraud, Executive Vice President, Head of International Hunter
Slide 3: Important Notice
Important Notice This presentation contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties, including without limitat
Slide 4: David Meeker, MD
David Meeker, M Rhythm
Slide 5: High-level Execution on Global Commercialization and Market Access for BBS, Clinical Development
High-level Execution on Global Commercialization and Market Access for BBS, Clinical Development Strong BBS Hypothalamic obesity Multiple development commercial execution Ph3 trial progressing programs advancing • Strong growth with $22.5M in • Ph3 trial on track to complete • RM-718: IND on track f
Slide 6: Six Presentations at ObesityWeek 2023
Six Presentations at ObesityWeek® 2023 Weight Reduction in Impact of Impact of 3-Year Setmelanotide Patients with Cardiac, Renal, and Setmelanotide on 4-Year Setmelanotide Setmelanotide on Weight Outcomes in Hypothalamic Obesity Endocrine/Diabetes Metabolic Syndrome Weight Outcomes of Metabolic Synd
Slide 7: Hypothalamic Obesity: Patients Achieved 25.5% Mean BMI Reduction at One Year
Hypothalamic Obesity: Patients Achieved 25.5% Mean BMI Reduction at One Year of Setmelanotide Therapy in Long-term Ext. Trial Patient who discontinued Patients on treatment at Month 12 Patient lost to follow-up (n=1) treatment because of an AE (n=1) (n=12) 0 5 Reinitiated 5 Dose Off treatment Dose O
Slide 8: Ph3 Hypothalamic Obesity Trial on Track to Complete Enrollment by end of 2023
Ph3 Hypothalamic Obesity Trial on Track to Complete Enrollment by end of 2023 >Two-thirds of patients * screened >70% of planned sites * Starting dose for all patients is 0.5mg QD; Maximum dose for patients<6yo is between 1.5mg QD and 3.0mg QD based on body now open weight; maximum dose for patients
Slide 9: Rare MC4R Pathway Diseases Combine for Significant Opportunity
Rare MC4R Pathway Diseases Combine for Significant Opportunity Approved for:€ Bardet-Biedl POMC, PCSK1 and LEPR syndrome deficiencies 4,000 - 5,000 600 – 2,500 patients in the U.S.* patients in the U.S.* Phase 3 Trial Initiated Hypothalamic obesity 5,000 – 10,000 patients in the U.S.* Phase 3 EMANAT
Slide 10: Jennifer Chien: BBS U.S. Launch
Jennifer Chien BBS U.S. Launch ® 10
Slide 11: Strong U.S. Demand Continues for BBS Launch to Date
Strong U.S. Demand Continues for BBS Launch to Date Cumulative New BBS Prescriptions since Launch > 545 >545* New BBS prescriptions launch to date > 425 >300* unique > 300 prescribers >200 > 50 >120 >330 * reimbursement approvals 2Q 2022 3Q 2022 4Q 2022 1Q 2023 2Q 2023 3Q 2023 New Prescriptions * As
Slide 12: Third Quarter 2023 Prescriptions and Approvals for Reimbursement Illustrate Continued Progress
Third Quarter 2023 Prescriptions and Approvals for Reimbursement Illustrate Continued Progress >120 80 Prescriptions received Approvals for reimbursement during 3Q 2023 received during 3Q 2023 ® 12
Slide 13: Snapshot of BBS Patients with Prescriptions
Snapshot of BBS Patients with Prescriptions Age Range Since Launch* Adult ~57% (18+) Adolescent ~24% (12-17) Pediatric ~19% (6-11) *As of September 30, 2023 ® 13
Slide 14: BBS IMCIVREE Prescribers by Specialty Since Launch
BBS IMCIVREE Prescribers by Specialty Since Launch 11% Endocrinology, 34% Pediatric Endocrinology >300* 24% Prescribers Primary Care as of 9/30/2023 28% Of prescribers ‘new to Rhythm’ 15% 16% Pediatrics 28% All others of prescribers have written more than one prescription *As of September 30, 2023 ®
Slide 15: Medicaid Access and Reimbursement Consistent with 80% of Covered Lives
Medicaid Access and Reimbursement Consistent with 80% of Covered Lives in States with Positive Coverage Policies or Decisions Medicaid Covered Lives ~85 million* ~80%** ~20%** of covered lives split between of covered lives in states with: states with: • no IMCIVREE prescription • an IMCIVREE policy
Slide 16: Vast Majority of IMCIVREE Prescription Re-authorizations Approved
Vast Majority of IMCIVREE Prescription Re-authorizations Approved ~75* approved at initial re-authorization >90% * re-authorization approvals (at 3-, 6- or 12- months) Majority of plans have 12-month re-auth timeframes *As of September 30, 2023 ® 16
Slide 17: New ICD-10 Diagnosis Code Established for BBS Effective Oct. 1
New ICD-10 Diagnosis Code Established for BBS Effective Oct. 1 Improves disease awareness, understanding and diagnosis and may enhance access to therapies • Prior, providers limited to utilizing ICD- 10 code Q87.89 - a generic code for congenital malformation syndromes • Specific BBS ICD-10 code all
Slide 18: Yann Mazabraud: EVP, Head of International
Yann Mazabraud EVP, Head of International ® 18
Slide 19: More than 100 International Patients on Reimbursed IMCIVREE Therapy
More than 100 International Patients* with Biallelic POMC/LEPR and/or BBS on Reimbursed IMCIVREE Therapy United Kingdom Netherlands Launched in Launched in POMC/LEPR; POMC/LEPR; BBS launch BBS launch mid-2024 in 2H2024 Germany Launched in BBS and France POMC/LEPR Reimbursed early- access programs fo
Slide 20: Solid Start for IMCIVREE Launch for BBS in Germany
Solid Start for IMCIVREE Launch for BBS in Germany Focus on engaging with physicians at care centers across the country Engaging care centers, large hospitals Rhythm@Home ~1,200 leads to prescriptions Estimated German prevalence* ~800 Patients diagnosed with BBS* Aach en >250 Patients with BBS ident
Slide 21: Rhythm at ESPE 2023
Rhythm at ESPE 2023 Symposium • Hyperphagia and early-onset, severe obesity: and the role of a personalized treatment approach of MC4R pathway diseases Oral presentations • Setmelanotide’s potential to reduce risk of cardiovascular disease, type 2 diabetes and metabolic syndrome in pediatric patient
Slide 22: Hunter Smith: 3Q 2023 Financial Results
Hunter Smith 3Q 2023 Financial Results ® 22
Slide 23: 3Q 2023 Financial Snapshot
3Q 2023 Financial Snapshot ($ in millions, except per share data and shares Three months ended Three months ended outstanding) September 30, 2023 September 30, 2022 Product revenue, net $22.5M $4.3M R&D expenses $33.6M $21.1M SG&A expenses $30.5M $21.9M Net Loss $(44.2)M $(40.9)M Shares outstanding
Slide 24: 3Q 2023 Financial Highlights
3Q 2023 Financial Highlights $299.3M 80% OpEx includes Non-GAAP cash equivalents and of 3Q 2023 revenue $8.5M OpEx Guidance short-term investments in stock-based for 2023: from U.S. sales as of September 30, of IMCIVREE compensation in 3Q; $210M to 2023 vs. 86% in $23.9M $220M** 2Q 2023 in 2023 year
Slide 25: David Meeker, MD: Conclusion
David Meeker, MD Conclusion ® 25
Slide 26: Plans for Continued Execution: Anticipated Upcoming Milestones and Data Readouts
Plans for Continued Execution: Anticipated Upcoming Milestones and Data Readouts Save the date: Anticipated clinical milestones Dec. 6, 2023 R&D Event: Early 2023: Initiate Ph 3 hypothalamic obesity trial Update on RYTM’s MC4R Pathway Program 2H2023: Present data analyses from Ph2 and LTE o Upda
Slide 27: Rhythm's Strategic Priorities for 2023
Rhythm’s Strategic Priorities for 2023 Execute on Enroll and execute Expand global commercial Phase 3 trial to IMCIVREE strategy evaluate opportunity with setmelanotide in and new product BBS launches hypothalamic with development obesity assets ® 27
Slide 28: Questions
Questions Rhythm
Rhythm Pharmaceuticals — Q3 2023 Earnings Presentation on 6ix