On May 7, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS),reported its financial and operating results for the first quarter ended March 31, 2020 and provided a business update (Press release, Radius, MAY 7, 2020, View Source [SID1234557289]).

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"In these challenging and unprecedented times, I am proud of the Radius team’s quick response and key measures to ensure the safety of our employees, while also providing patients and customers with uninterrupted access to TYMLOS and our investigational medicines," said Jesper Hoeiland, former Chief Executive Officer of Radius. "I am very enthusiastic about the prospects for Radius and look forward to working with Kelly to make this transition as seamless and effective as possible," added Jesper.

"I look forward to building on the strong momentum established by Jesper with the TYMLOS franchise and guiding the development of the Company and the achievement of its objectives and advancing it to the next level," said Kelly Martin, President and CEO of Radius Health.

COVID-19 Response

In response to the ongoing COVID-19 pandemic, Radius has implemented a number of initiatives to support the safety of its employees and customers and mitigate impacts on the supply of TYMLOS and its investigational medicines to patients and healthcare providers, and advance its clinical studies. Our current expectations for the timing of enrollment and completion of our ongoing clinical trials, particularly for wearABLe and EMERALD, are based on our assumptions that during the second half of 2020, the effects of the COVID-19 pandemic will begin to subside as "shelter-in-place" policies and other restrictive measures are relaxed. As a result, we believe that enrollment rates will increase to near normal pre-pandemic levels, and for our wearABLe trial, our ex-U.S. trial sites are activated within the timelines we expect. The Company will continue to assess the pandemic and any potential impact it may

have on its operations, financial condition, guidance and plans. The mitigation measures that we have implemented to address potential challenges from the pandemic include the following:

Safety of Employees: A work-from-home mandate for employees was implemented in mid-March with enhanced utilization of technical tools and capabilities to accomplish secure remote access and conduct of virtual business.

Patient Access to TYMLOS: With the implementation of a new streamlined distribution model utilizing several specialty distributors, Radius is able to support seamless patient access to TYMLOS. TYMLOS is administered at home and over 90% of patients currently have the option to receive TYMLOS via home delivery. To date, Radius has observed no disruptions in its supply chain for the production and shipments of TYMLOS or its clinical trial medications. The Company has secured inventories of TYMLOS and its investigational medications until the end of the year and continues to manufacture to ensure continuity of supply.

Continued Patient Care and HCP Support: Radius’ commercial organization is providing virtual interactions to connect with healthcare providers, assisting their offices with continued access to TYMLOS tools and enabling supply of samples via online processes. The Company’s clinical educator team has also switched to virtual practices to continue support to both new patients and patients on treatment.

Supporting Ongoing Clinical Trials: Radius is working with clinical trial sites and clinical research organizations to provide virtual capabilities for site initiations, remote trial monitoring, virtual safety assessments at home, options for local procedures to reduce travel, and home delivery of investigational products. The Company is following regulatory guidance from the FDA and EMA on the conduct of clinical trials during the COVID-19 pandemic, providing support to each site, and prioritizing study visits for key efficacy assessments to maintain data quality and integrity.

TYMLOS (abaloparatide) injection

First quarter 2020 U.S. net sales of TYMLOS were $47.9 million, a 61% increase over the first quarter of 2019.

By the end of the first quarter 2020, TYMLOS’ average U.S. anabolic market share rose to 44% and it achieved a 53% share of new anabolic patient starts. With this growth trajectory, Radius remains confident TYMLOS will become the U.S. anabolic market leader in 2020 (based on TRx1).

In April, there has been a decline in new patient starts due to the decrease in physician office visits resulting from government restrictions in response to the pandemic. Assuming that during the second half of the year the impacts of the pandemic begin to subside as the shelter-in-place measures are relaxed and states re-open, Radius expects new TYMLOS prescriptions to increase and return to near normal pre-pandemic levels.

During the first quarter of 2020, Radius executed a transition of the Company’s external distribution model from full-line wholesalers to specialty distributors and specialty pharmacies. Under this distribution model, both the specialty distributors and specialty pharmacies take physical delivery of TYMLOS and pharmacies dispense TYMLOS directly to patients. This new streamlined distribution model has further improved the home delivery process for TYMLOS, achieved sustainable cost efficiencies, and is expected to have a positive impact on the gross to net sales ratio for TYMLOS.

Pipeline Highlights

Abaloparatide-SC

The ATOM Phase 3 Study, which is assessing the efficacy and safety of abaloparatide-SC in men with osteoporosis, has completed approximately 90% of its enrollment. Radius expects to complete recruitment this year and report top-line data in the second half of 2021.

The TYMLOS bone histomorphometry study, which evaluated the early effects of abaloparatide-SC on tissue-based indices of bone formation and resorption in postmenopausal women, met its primary endpoint of change from baseline to 3 months in mineralizing surface in the cancellous bone envelope, which is a strong indicator of bone formation. Radius expects to present data from this study in the second half of 2020.

Abaloparatide-Patch

The wearABLe Phase 3 study continues to advance enrollment amid slowdown from the pandemic. The screening failure rate has significantly decreased after the implementation of a revised enrollment plan and addition of targeted bone specialty sites in the U.S. In Europe, regulatory reviews are underway, with first conditional approvals already received for sites to be initiated in the second quarter of this year.

At this time, Radius expects to complete recruitment in the later part of the third quarter of 2020 and report top-line data from the study in the second half of 2021.

Elacestrant

The EMERALD Phase 3 study is continuing to advance its global enrollment. The recruitment activity which slowed down in April because of the pandemic is resuming at sites in countries where COVID-19 restrictions have been eased.

At this time, Radius expects completion of recruitment in the study in the fourth quarter of this year and to report top-line data in the second half of 2021.

Financial Highlights and Guidance

Radius has decreased its full-year TYMLOS U.S. net revenue guidance mid-point by 10%, taking the impacts from the COVID-19 pandemic into consideration, and assuming a return to normalized pre-pandemic demand patterns in the second half of 2020. At this time, the Company expects full-year TYMLOS U.S. net revenue to be between $190 and $220 million and its full-year cash burn to be below $100 million, excluding net cash from the existing non-dilutive credit facility.

Radius had $23 million net cash outflows in the first quarter and closed the quarter with a $138 million cash balance. The Company has drawn $10M from the term loan that it secured in January. Radius expects access to non-dilutive financing for another $30M from the second and third tranche of the term loan and up to $20M from the working capital revolver that it entered into in January.

Anticipated Milestones in 2020

Clinical Pipeline

Complete recruitment in Phase 3 ATOM study

Complete recruitment in Phase 3 wearABLe study

Complete recruitment in Phase 3 EMERALD study

TYMLOS

Grow full-year TYMLOS U.S. net sales to between $190 and $220 million

Capture U.S. anabolic TRx market leadership in 2H 2020

First Quarter 2020 Financial Results

Three Months Ended March 31, 2020

For the three months ended March 31, 2020, Radius reported a net loss of $37.7 million, or $0.81 per share, compared to a net loss of $42.8 million, or $0.94 per share, for the three months ended March 31, 2019.

For the three months ended March 31, 2020, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, depreciation, non-cash interest obligations under debt obligations, and amortization of intangible assets, was $27.4 million, or $0.59 per share, compared to non-GAAP adjusted net loss of $31.8 million, or $0.70 per share, for the three months ended March 31, 2019.

For the three months ended March 31, 2020, we recorded approximately $47.9 million of net product revenue compared to $29.8 million for the three months ended March 31, 2019.

For the three months ended March 31, 2020, research and development expense was $39.0 million compared to $23.3 million for the three months ended March 31, 2019, an increase of $15.8 million, or 68%. This increase was primarily driven by a $11.1 million increase in abaloparatide-patch program costs, a $3.4 million increase in elacestrant program costs, a $0.9 million increase in professional support costs, and a $0.4 million increase in abaloparatide-SC program costs.

For the three months ended March 31, 2020, selling, general and administrative expense was $36.4 million compared to $41.2 million for the three months ended March 31, 2019, a decrease of $4.8 million, or 12%. This decrease was primarily the result of a $2.9 million decrease in professional support costs, a $1.4 million decrease in compensation and travel entertainment costs, and a $0.6 million decrease in occupancy and depreciation costs. These decreases were partially offset by a $0.1 million increase in other operating expenses.

As of March 31, 2020, Radius had $138.5 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of March 31, 2020 and funds available to us through our credit facilities, we believe that, prior to the consideration of potential proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for at least twelve months from the date of this press release.