Company Overview
Radius Health, Inc. (RDUS) is a specialty biopharmaceutical company focused on developing and commercializing innovative therapeutics in the areas of bone health, neuroscience, and oncology. The company's journey has been marked by both challenges and breakthroughs, as it navigates the dynamic landscape of the pharmaceutical industry.
Radius Health was founded in 2003 with the goal of addressing unmet medical needs in the field of bone health. The company's flagship product, TYMLOS (abaloparatide) injection, was approved by the FDA in 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture. This approval was a significant milestone, as TYMLOS became the first new anabolic therapy for osteoporosis to be introduced in the United States in nearly two decades. The company commenced U.S. commercial sales of TYMLOS in May 2017, which has since represented Radius' sole source of product revenue.
Product Pipeline and Development
In addition to TYMLOS, Radius has been actively developing other product candidates to expand its portfolio. One such candidate was abaloparatide-transdermal system (abaloparatide-TD), for which the company conducted phase 3 clinical trials. However, the trial did not meet its primary or secondary endpoints, leading Radius to announce in June 2022 the decision to cease all work on abaloparatide-TD.
Another product in Radius' pipeline is elacestrant (RAD1901), which has shown promise in the treatment of breast cancer. In June 2022, Radius' licensee, Berlin-Chemie, submitted a New Drug Application to the FDA for elacestrant in patients with ER-positive, HER2-negative advanced or metastatic breast cancer, marking a significant step forward in the development of this asset.
Since the launch of TYMLOS, Radius has continued to explore the potential of abaloparatide in additional indications, including the treatment of osteoporosis in men. In October 2021, the company announced positive top-line results from its Phase 3 clinical trial evaluating abaloparatide-SC for use in males with osteoporosis, further reinforcing the versatility of its lead asset.
The company's research and development efforts have not been limited to abaloparatide. Radius has also been actively developing RAD011, a pharmaceutical-grade synthetic cannabidiol oral solution, for the treatment of rare neurological disorders such as Prader-Willi syndrome and Angelman syndrome. In July 2022, the company announced that the first patient had been randomized in the Phase 2/3 pivotal study for RAD011 in Prader-Willi syndrome, a significant step forward in the asset's clinical development.
Financials
Financially, Radius has demonstrated resilience in the face of industry challenges. As of June 30, 2022, the company reported total cash and cash equivalents of $72.5 million and a net debt position of $190.9 million, with the majority of the debt attributed to the company's 3% Convertible Senior Notes due 2024. While the company has incurred net losses since its inception, its focus on cost management and strategic partnerships has enabled it to navigate the capital-intensive nature of the pharmaceutical industry. In 2021, Radius repurchased a portion of its outstanding convertible notes, resulting in a gain on extinguishment of debt, which helped to improve its financial position.
In the most recent quarter, Radius reported revenue of $672,897,000 and a net loss of $17,964,000. The company's operating cash flow for the quarter was negative $1,299,000, while free cash flow was negative $26,107,000. These figures underscore the ongoing challenges faced by the company as it continues to invest in its product pipeline and commercial operations.
Liquidity
In terms of commercial performance, Radius' sole approved product, TYMLOS, has continued to gain traction in the U.S. osteoporosis market. As of July 1, 2022, TYMLOS was available and covered for approximately 284 million U.S. insured lives, representing approximately 99% of U.S. commercial and 80% of Medicare Part D insured lives. The company has also secured licensing agreements with Teijin Pharma Limited for the development and commercialization of abaloparatide-SC in Japan, as well as with Berlin-Chemie AG for the development and commercialization of the investigational product candidate elacestrant in global markets.
To support its ongoing operations and development activities, Radius maintains a $25 million secured revolving credit facility available under its Revolving Credit Agreement with MidCap Funding IV Trust. This facility provides additional financial flexibility as the company continues to advance its product pipeline and commercial initiatives.
Future Outlook and Challenges
Looking ahead, Radius faces both opportunities and challenges. The company's pipeline expansion efforts, particularly in the realm of rare neurological disorders, present potential avenues for growth and diversification. However, the competitive landscape in the osteoporosis market, as well as the inherent risks associated with drug development and regulatory approval processes, remain key considerations for the company's long-term success.
Radius Health's journey exemplifies the dynamic nature of the biopharmaceutical industry. Through its focus on innovation, strategic partnerships, and disciplined financial management, the company has navigated the evolving landscape of bone health therapeutics, positioning itself for potential future growth and value creation for its stakeholders.
Product Segments
Radius Health's business is primarily divided into two main product segments: TYMLOS (abaloparatide-SC) and investigational product candidates.
TYMLOS (abaloparatide-SC) Segment TYMLOS remains Radius Health's primary revenue driver, generating $95.49 million in net product revenue for the six months ended June 30, 2022, which accounted for 94% of the company's total revenue. The company is actively pursuing additional indications for TYMLOS, including its use in the treatment of men with osteoporosis. Following positive top-line results from the Phase 3 ATOM Trial in October 2021, Radius filed a supplemental new drug application (sNDA) with the FDA in February 2022, seeking approval for TYMLOS in men with osteoporosis at high risk for fracture.
Investigational Product Candidates Segment This segment includes RAD011 and elacestrant (RAD1901). RAD011, a pharmaceutical-grade synthetic cannabidiol oral solution, is being developed for various rare neurological disorders. The SCOUT-15 study, a Phase 2/3 pivotal study evaluating RAD011 for the treatment of hyperphagia and related neuro-behavioral symptoms in Prader-Willi syndrome (PWS), began in July 2022. RAD011 has received Orphan Drug Designation from the FDA for the treatment of PWS, Angelman syndrome, and infantile spasms.
Elacestrant, licensed to Berlin-Chemie AG in 2020, has shown promise in the treatment of estrogen receptor-positive, HER2-negative advanced or metastatic breast cancer. Following positive top-line results from the EMERALD Phase 3 study in October 2021, Berlin-Chemie, with support from Radius, submitted a new drug application (NDA) to the FDA for elacestrant in June 2022.
Radius Health's focus on these two segments demonstrates its commitment to leveraging its expertise in bone health while expanding into new therapeutic areas with significant unmet medical needs. The company's strategic approach to product development and commercialization positions it to potentially capture value across multiple indications and patient populations.