Radius Health (RDUS) sees growth of 14% for new U.S. TYMLOS patients in Q1
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Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS), provided the following business update. The Company’s first quarter 2021 earnings will take place on Friday, May 7 at 8:30am EST.
- Growth of 14% for new U.S. TYMLOS® patients in Q1, 2021 vs. Q4, 2020
- Q1, 2021 TYMLOS net revenue impacted by seasonality and distribution channel destocking
- April, 2021 month-to-date new patient adds indicate significant patient growth
- Three pivotal studies: all remain on track for 2H, 2021 readouts: elacestrant (EMERALD), abaloparatide (ATOM & wearABLe)
- Bioequivalence (TD) and human factor studies (ATOM & wearABLe): studies completed and successful outcomes achieved
- RAD011 June Type C FDA meeting confirmed; Prader Willi Syndrome (PWS) protocol discussion
- PWSA Conference, June 23: RAD011 abstract accepted, oral presentation on previous Phase 2 data
- Lifecycle for RAD011: additional target orphan indications – beyond PWS – being analyzed
Patient growth increased by 14% in Q1, 2021 vs. Q4, 2020. For the first quarter, patient adds were strong in January, weakened in the short and weather impacted month of February, and rebounded in March. To date for the month of April, the new patient numbers appear robust.
Within the first quarter, there were seasonally driven headwinds for the net revenue totals. These are consistent with previous years, although Q1 2020 – as a comparator – was an unusual quarter given the underlying patient and HCP activity-based volatility resulting from COVID-19. We also experienced reasonable destocking within our distribution channel for the quarter. We expect net revenues will normalize throughout the balance of 2021.
Male Indication (ATOM Study)
Completed several human factors studies designed to evaluate the usability of the current commercial TYMLOS product. These formative human factors studies included both men and women, and the results were positive. We anticipate that the results will be included in an sNDA submission to add the male population to the label.
TD (wearABLe Study) Sterile Product and Human Factor Studies
Study completed to assess commercial sterile patch pharmacokinetic performance compared to the initial Phase 3 product. The results of the study were positive and passed the strict FDA bioequivalence criteria. This will enable a transition of all remaining patients in our wearABLe Phase 3 study from the current product to the sterile commercial product.
Final human factors studies were also completed, and the results were positive. This enables us to proceed to summative studies and would be an integral component in an anticipated abaloparatide-TD NDA submission.
Pivotal data readout remains on track for 2H 2021. We continue to work closely with our partner, the Menarini Group, on execution, implementation, and progression of the program.
FDA Type C meeting is scheduled to take place in June, 2021. This meeting will review and discuss our proposed Phase 3 protocol for PWS. A recent advisory board meeting provided us with additional insights and considerations for the proposed pivotal trial.
Beyond PWS, the Company is critically assessing additional orphan indications that might be applicable for the RAD011 molecule. Several disease specific opportunities will be considered for clinical advancement over the course of the next 12 months.
The upcoming PWSA/USA Virtual Medical and Scientific Meeting will take place on June 23 and 24. The Company’s abstract “Preliminary results from a randomized, placebo-controlled Phase 2 trial using synthetic cannabidiol (CBD) oral solution in 7 individuals with Prader Willi Syndrome,” has been accepted. Results will be presented during an oral presentation.
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