Rhythm Pharmaceuticals, Inc. · NASDAQ:RYTM
Rhythm Pharmaceuticals — Q3 2022 Earnings Presentation
31 slides from Rhythm Pharmaceuticals's earnings presentation, Nov 8, 2022
Slide 1: Third Quarter 2022 Financial Results and Business Update
Rhythm Pharmaceuticals Third Quarter 2022 Financial Results and Business Update November 8, 2022 ® © 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: Forward Looking Statements
Forward Looking Statements 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 witho
Slide 4: David Meeker, MD
David Meeker, M Rhython
Slide 5: Executing on our Global Strategy to Deliver a Precision Medicine Addressing Unmet Medical Needs
Executing on our Global Strategy to Deliver a Precision Medicine Addressing Unmet Medical Needs Strong Start to International Market Potential for Meaningful U.S. BBS Launch Access Advancing Label Expansion • >120 prescriptions written • EC* authorization for BBS granted • Received FDA Breakthrough
Slide 6: Presentations Delivered at ObesityWeek 2022
11 Presentations Delivered at ObesityWeek® 2022 ® 6
Slide 7: Setmelanotide and Hypothalamic Obesity: A Transformative Opportunity for Rhythm
Setmelanotide and Hypothalamic Obesity: A Transformative Opportunity for Rhythm ✓ Unmet medical need is high; no approved therapies 5,000 – 10,000* ✓ MC4R pathway deficiency following patients injury to hypothalamic region Estimated U.S. prevalence ✓ Patients are identified; no genetic testing requi
Slide 8: Setmelanotide Achieved Significant BMI Reduction in Patients with Hypothalamic Obesity in Phase 2 Trial
Setmelanotide Achieved Significant BMI Reduction at 16 Weeks in Patients with Hypothalamic Obesity in Phase 2 Trial Full analysis set population (N=18) 16 of 18 14 of 18 −14.5% patients achieved patients achieved mean change primary endpoint >10% reduction of >5% reduction in BMI in BMI in BMI at 16
Slide 9: Setmelanotide Achieved Consistent BMI Reduction at Week 16
Setmelanotide Achieved Consistent BMI Reduction at 16 Weeks Patients not achieving ≥10% reduction of 5 BMI at 16 weeksa 2.3 0.4 0 BMI reduction from baseline, % -2.7 -2.7 -5 –5% change -6.9 -7.0a -6.7 -6 -8.2b -10 –10% change -10.2 -10.0 -10.1 -12.8 -12.7 -15 -14.4 -14.4 -16.1 -20 -18.4 -21.1 -22.7
Slide 10: Mean Percent Change in BMI in Long-term Extension Trial
Mean Percent Change in BMI in Patients With ≥3 Months of Follow-up in the Long-term Extension Trial Primary study 16 weeks Long-term extensiona 0 -5 BMI reduction from baseline, % -10 -15 -16.8 -20 (n=13) -21.1 -25 (n=13) -26.7 -30 (n=5) -35 -40 -45 0 4 8 12 16 20 24 28 13 32 36 40 25 44 Weeks of in
Slide 11: Phase 3 Double-blind, Randomized Controlled Trial Expected to Begin in Early 2023
Phase 3 Double-blind, Randomized Controlled Trial with 120 Patients Expected to Begin in Early 2023 Dose Double-blind, placebo-control titration Screening and Randomization Setmelanotide QD (n=80) Open-label setmelanotide: placebo 2:1 extension Placebo QD (n=40) Up to 52 weeks 8 weeks Starting dose
Slide 12: Multiple Clinical Trials Ongoing to Expand IMCIVREE Label and Overall Opportunity
Multiple Clinical Trials Ongoing to Expand IMCIVREE Label and Overall Opportunity Pediatrics Trial Weekly Formulation Phase 3 Phase 3 Patients aged 2 to <6 years Switch Trial Hypothalamic obesity Phase 3 Trial planned for early 2023 Phase 3 Trial Phase 2 Trial ® 12
Slide 13: Jennifer Chien: BBS U.S. Launch
Jennifer Chien BBS U.S. Launch ® 13
Slide 14: The Journey To Treatment with IMCIVREE and Beyond
The Journey To Treatment with IMCIVREE and Beyond PATIENTS & CAREGIVERS Disease Clinical Diagnosis Decision Prescribe Access Maintenance Education Suspicion to Treat IMCIVREE PHYSICIANS ® 14
Slide 15: Continued Momentum Across First Full Quarter of Launch
Continued Momentum Across First Full Quarter of Launch >120* >80* >40* Approvals for BBS unique reimbursement prescriptions prescribers *Cumulative as of September 30, 2022 ® 15
Slide 16: BBS IMCIVREE Prescribers by Specialty
BBS IMCIVREE Prescribers by Specialty 38% 8% >80* unique prescribers 19% Source of prescriptions 24% 24% 11% 76% Pediatric Endocrinology Pediatrics All others Primary Care Endocrinology New Physicians Targeted Physicians *As of September 30, 2022 ® 16
Slide 17: Approximately 90% of Initial BBS Prescriptions Fall Under Commercial and Medicaid Plans
Approximately 90% of Initial BBS Prescriptions Fall Under Commercial and Medicaid Plans >40 approvals for reimbursement • Reimbursement process 48% 42% takes between one to three months • Following initial 7% approvals, subsequent approvals are faster 3% Commercial Medicaid Medicare Federal *As of S
Slide 18: Snapshot of Patient Prescriptions Received in First Full Quarter
Snapshot of Patient Prescriptions Received in First Full Quarter Age Range % Adult (18+) ~43 Adolescent (12-17) ~27 Pediatric (6-11) ~30 >90% of BBS prescriptions are written for patients who have consented to InTune *As of September 30, 2022 ® 18
Slide 19: Patients Benefiting from IMCIVREE Therapy
Patients Benefiting from IMCIVREE Therapy “ My daughter has reached her maintenance dose and is feeling good, “My son used to sleep all day and stay up all night, since he has been on IMCIVREE he “ My son is more confident, his clothes are too big, and he doesn’t ask for “ We almost stopped treatmen
Slide 20: Multi-channel Engagement to Continue Identifying Patients with BBS
Multi-channel Engagement to Continue Identifying Patients with BBS Territory Manager Patient Educations engagement Managers Undiagnosed Congresses and Patient advocacy professional groups societies Suspected Diagnosed not yet known to RYTM Educational Speaker programs materials Identified and diagno
Slide 21: Yann Mazabraud, EVP, Head of International
Yann Mazabraud EVP, Head of International ® 21
Slide 22: Significant Market Opportunity for BBS and POMC, PCSK1 and LEPR Deficiencies in Europe
Significant Market Opportunity for BBS and POMC, PCSK1 and LEPR Deficiencies in Europe POMC, PCSK1 and LEPR Bardet-Biedl Syndrome Deficiency Obesities ~100 >1,500 individuals identified individuals identified in EU4 + UK in EU4 + UK (~20 academic medical centers with >40 BBS patients) Estimated Euro
Slide 23: European Launch Update for POMC, PCSK1 and LEPR Deficiency
European Launch Update for POMC, PCSK1 and LEPR Deficiency ✓ United Kingdom • Italy Commercial launch in October On track for launch by year end 2022 2022 following UK NICE recommendation • Netherlands On track for launch by year end 2022 ✓ Germany Launched, first sales in 2Q22 • Israel following ex
Slide 24: IMCIVREE for Treatment of Obesity and Control of Hunger in Patients with Bardet-Biedl Syndrome
IMCIVREE for Treatment of Obesity and Control of Hunger in Patients with Bardet-Biedl Syndrome EC Marketing Authorization Received Sept. 6, 2022 France Italy Reimbursed early-access program achieved in July 2022 On track for dossier submission by year end Germany Spain G-BA exemption procedure ongoi
Slide 25: 1st International Meeting on Pathway-Related Obesity (IMPROVE 2022)
1st International Meeting on Pathway-Related Obesity (IMPROVE 2022) Welcomes ~100 Physicians and Scientists in October 2022 in Berlin ® 25
Slide 26: Hunter Smith: 3Q 2022 Financial Results
Hunter Smith 3Q 2022 Financial Results ® 26
Slide 27: 3Q22 Financial Highlights: Strong Cash Position
3Q22 Financial Highlights: Strong Cash Position $347.8 $140 $37.5 milliona millionb millionc Cash, cash equivalents Successfully completed Secured second of two and short-term public offering with tranches from investments exercise of underwriters’ HealthCare Royalty option Partners following EC mar
Slide 28: 3Q 2022 Financial Snapshot
3Q 2022 Financial Snapshot ($ in millions except as noted, per share data Three months ended Three months ended and shares outstanding) September 30, 2022 September 30, 2021 Product revenue, net $4.3M $1.0M License revenue -- _ R&D expenses $21.1M $27.5M SG & A expenses $21.9 $17.5M Net (loss) $(40.
Slide 29: David Meeker, MD: Conclusion
David Meeker, MD Conclusion ® 29
Slide 30: Rhythm's Strategic Priorities for 2022 and 2023
Rhythm’s Strategic Priorities for 2022 and 2023 Execute on U.S. Achieve access Initiate Phase 3 Expand commercial and launch trial to evaluate IMCIVREE strategy with IMCIVREE for setmelanotide in opportunity BBS launch both BBS and hypothalamic through POMC, PCSK1 obesity additional and LEPR in in e
Slide 31: Questions
Questions Rhython
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