On August 3, 2017 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a fully integrated science-driven biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported its financial results for the second quarter ended June 30, 2017, and provided a business update (Press release, Radius, AUG 3, 2017, View Source [SID1234520046]). As of June 30, 2017, Radius had $215 million in cash, cash equivalents and marketable securities. Schedule your 30 min Free 1stOncology Demo! "This is a very exciting time for Radius, as the company builds out its commercial organization and launches TYMLOS, the first new bone building anabolic approved by the FDA in 15 years. There is a high unmet medical need among postmenopausal women with osteoporosis at high risk for fractures for therapies which can safely and effectively reduce that risk," said Jesper Høiland, President and CEO of Radius. "I am confident that we have the leadership and resources to build this important brand globally and to continue to advance our strong pipeline assets, including elacestrant."
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"While early in the launch of TYMLOS, we are extremely pleased with the substantial progress we have made and the strong support we have received from payors, physicians, and patients," said David Snow, Chief Commercial Officer of Radius. "We are already ahead of plan in contracting with managed care organizations with access to over 133 million covered lives across Commercial and Medicare Part D plans, and highly gratified that Express Scripts has aligned with us on TYMLOS to assure that appropriate patients have access to therapy with lower out of pocket costs."
TYMLOS (abaloparatide)
Radius received FDA approval for TYMLOS on April 28, 2017, for the treatment of postmenopausal women with osteoporosis at high risk of fracture, and began shipments to wholesalers at the end of May 2017. In the second quarter of 2017, we reported sales of TYMLOS from the first four weeks of launch of approximately $1.0 million.
In May 2017, Radius announced positive top-line results from the completed 24-month ACTIVExtend clinical trial of TYMLOS, which met all of its primary and secondary endpoints. In ACTIVExtend, patients who had completed 18 months of TYMLOS (abaloparatide) injections or placebo in the ACTIVE Phase 3 trial were transitioned to received 24 additional months of open-label alendronate. For the subset of ACTIVE trial patients that enrolled in the ACTIVExtend trial, the previous TYMLOS-treated patients had a significant 84% relative risk reduction in the incidence of new vertebral fractures compared with women who received placebo followed by alendronate. They also demonstrated a 39% risk reduction in nonvertebral fractures, a 34% risk reduction in clinical fractures and a 50% risk reduction in major osteoporotic fractures compared with women who received placebo followed by alendronate. At the 43-month time point, for all patients that enrolled in the ACTIVE trial, TYMLOS-treated patients had a statistically significant risk reduction in new vertebral fractures, nonvertebral fractures, clinical fractures, and major osteoporotic fractures. While not a pre-specified endpoint, there was also a statistically significant risk reduction in hip fractures in the TYMLOS-treated patient group compared with women who received placebo followed by alendronate at the 43-month time point. The adverse events reported during the alendronate treatment period were similar between the previous TYMLOS-treated patients and the previous placebo group. The incidences of cardiovascular adverse events including serious adverse events were similar between groups. There have been no cases of osteonecrosis of the jaw (ONJ) or atypical femoral fracture (AFF) in the entire TYMLOS development program. Additional results from the completed ACTIVExtend trial will be presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting September 8-11, 2017 in Denver, Colorado.
We plan to submit an sNDA to the FDA in connection with the ACTIVExtend results by year end.
On July 13, 2017, Radius announced that it had entered into a license and development agreement with Teijin Limited in Japan for abaloparatide-SC, which combined with the U.S., provides Radius with access to the largest two markets for bone anabolics, which account for approximately 80% of global sales. Teijin is developing abaloparatide-SC in Japan under an agreement with Ipsen Pharma S.A.S. and has initiated a Phase 3 trial in Japanese patients with osteoporosis. The license agreement provides Teijin with the right to manufacture abaloparatide-SC for commercial supply in Japan, as well as the right to reference Radius’ NDA and MAA and regulatory data to support its marketing application in Japan and to use Radius intellectual property, and provides Radius with an option to negotiate a co-promotion agreement for abaloparatide-SC in Japan. Radius will also receive upfront and milestone payments and royalties for the rights granted to Teijin. Teijin is conducting and funding its Japanese Phase 3 development program and the parties may further collaborate in the future in new indications for abaloparatide-SC. Radius maintains full global rights to its development program for abaloparatide-transdermal (abaloparatide-TD), which is not part of the agreement with Teijin.
Pipeline Updates
Eladynos (abaloparatide-SC)
Radius’ European Marketing Authorisation Application (MAA) for Eladynos (abaloparatide-SC) for the treatment of postmenopausal women with osteoporosis is under review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). On July 21, 2017, the CHMP, the scientific committee of the EMA, issued a second Day-180 List of Outstanding Issues. Radius is working with the CHMP to address these issues, and we expect an opinion from the CHMP regarding the MAA for Eladynos prior to the end of 2017.
Elacestrant (RAD1901)
In June 2017, Radius reported additional positive data from the ongoing Phase 1 dose-escalation and expansion study at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) in Chicago. As of the study cut-off date of April 28, 2017, the elacestrant single agent objective response rate was 23% in heavily pre-treated patients with advanced ER-positive breast cancer. In the 400 mg patient group of 26 patients with mature data, the median progression free survival was 4.5 months and there were five confirmed partial responses. These results showed that elacestrant was well-tolerated with the most commonly reported adverse events being low grade nausea and dyspepsia. To date, no dose limiting toxicities have been reported in the elacestrant program. We recently completed patient enrollment in both of our ongoing elacestrant Phase 1 breast cancer trials.
In June 2017, we discussed the data from the ongoing Phase 1 studies with the FDA to gain alignment on defining the next steps for our elacestrant breast cancer program, including the design of a Phase 2 trial. Following this discussion, the FDA agreed that a single-arm monotherapy Phase 2 study of under 200 patients is appropriate and provided additional feedback on the proposed clinical protocol, including confirmation that the primary endpoint will be objective response rate ("ORR"), coupled with durability of response ("DOR"). The FDA indicated that, depending on the study results, which must demonstrate superiority to then available therapies, the single-arm Phase 2 trial could be considered a pivotal study for accelerated approval as long as we have commenced a confirmatory study by the time of our NDA submission. We will provide further study details when the Phase 2 study is started and will continue to pursue additional pathways to accelerated approval.
Elacestrant is also being evaluated at low doses as an estrogen receptor ligand for the potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. We expect to report results from our Phase 2b clinical study of elacestrant for the potential treatment of postmenopausal vasomotor symptoms in the second half of 2017.
Abaloparatide-TD
We are focused on completing the manufacturing, scale-up, production, and other required activities needed to initiate a pivotal study to evaluate bioequivalence to TYMLOS. We believe that the transdermal patch program has the potential to allow physicians who treat osteoporosis, but rarely use injectable drugs, an opportunity to expand their practices to include the use of anabolic therapy. We will provide an update on these activities before the end of 2017.
RAD140
An investigational new drug application, or IND, submitted to the FDA for RAD140, a selective androgen receptor modulator, has been accepted. We expect to initiate a first-in-human Phase 1 clinical trial in women with hormone receptor positive breast cancer in the second half of 2017.
Radius Anticipates the Following Milestones
Abaloparatide-SC
Receive a CHMP opinion regarding the EMA’s review of the abaloparatide-SC MAA prior to the end of 2017
Enter into a partnership for the potential commercialization of abaloparatide-SC outside the U.S. and Japan prior to commercial launch in the European Union
Report additional clinical results from the recently completed 24-month ACTIVExtend clinical trial at the ASBMR Annual Meeting in September 2017
Submit an sNDA in connection with the ACTIVExtend data to FDA by year end
Elacestrant
Complete ongoing Phase 1 breast cancer clinical trials
Initiate a Phase 2 single-arm monotherapy clinical trial in metastatic breast cancer patients in early 2018 with a goal of accelerated approval
Complete and report results from our ongoing Phase 2b vasomotor trial in the second half of 2017
RAD140
Initiate a first-in-human Phase 1 study in the second half of 2017 in women with hormone receptor positive breast cancer
Radius Expects To Make Presentations at the Following Upcoming Conferences
On August 10, 2017, Radius President and CEO, Jesper Høiland, will make a presentation and host one-on-one meetings at the Canaccord Genuity Growth Conference in Boston.
On September 6, 2017, Dr. Alison O’Neill, V.P., Clinical Development, will present on a Breast Cancer panel and host one-on-one meetings at the Citi 12th Annual Biotech Conference in Boston.
On September 8-11, 2017 Radius will be present 7 abstracts regarding abaloparatide-SC at the ASBMR Annual Meeting in Denver, Colorado, including an oral plenary presentation.
On September 13, 2017, Jesper Høiland, Radius President and CEO, will participate in a fireside chat and host one-on-one meetings at the Morgan Stanley 15th Annual Global Healthcare Conference in New York.
On September 25, 2017, Jesper Høiland, Radius President and CEO, will present and host one-on-one meetings at the Cantor Fitzgerald Global Healthcare Conference in New York.
Second Quarter 2017 Financial Results
Three Months Ended June 30, 2017
For the three months ended June 30, 2017, Radius reported a net loss of $68.4 million, or $1.58 per share, compared to a net loss of $43.4 million, or $1.01 per share, for the three months ended June 30, 2016, for an increase of 58%.
For the three months ended June 30, 2017, Radius reported TYMLOS net revenues of about $1.0 million, which reflects the first four weeks of sales. Radius had no revenues in the three months ended June 30, 2016 as the FDA approved TYMLOS on April 28, 2017.
Research and development expense for the three months ended June 30, 2017, was $19.7 million compared to $26.9 million for the three months ended June 30, 2016, a decrease of $7.2 million, or 27%. This decrease was primarily driven by a $5.3 million decrease in regulatory and professional fees associated with abaloparatide-SC regulatory applications, a $5.1 million decrease in elacestrant (RAD1901) project costs, and a $1.2 million decrease in development costs associated with abaloparatide-TD. This decrease was partially offset by a $4.5 million increase in compensation expense, including stock-based compensation, due to the increase in headcount, including the medical science liaisons to support the TYMLOS launch.
Selling, general, and administrative expense for the three months ended June 30, 2017, was $50.1 million compared to $17.2 million for the three months ended June 30, 2016, an increase of $32.9 million, or 192%. This increase was primarily the result of an increase of approximately $9.5 million in professional fees and support costs during the three months ended June 30, 2017, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $19.6 million increase in compensation expense, including stock-based compensation, due to an increase in headcount, due largely to the hiring of the U.S. sales force and other functions to support the launch of TYMLOS and general purposes.
Six Months Ended June 30, 2017
For the six months ended June 30, 2017, Radius reported a net loss of $125.4 million, or $2.90 per share, compared to a net loss of $83.9 million, or $1.95 per share, for the six months ended June 30, 2016, for an increase of 49%.
For the six months ended June 30, 2017 Radius reported TYMLOS net revenues of about $1.0 million, which reflects the first four weeks of sales. Radius had no revenues in the six months ended June 30, 2016 as the FDA approved TYMLOS on April 28, 2017.
Research and development expense for the six months ended June 30, 2017, was $39.2 million compared to $54.4 million for the six months ended June 30, 2016, for a decrease of $15.2 million, or 28%. This decrease was primarily driven by a $12.1 million decrease in abaloparatide-SC project costs, a $10.4 million decrease in elacestrant (RAD1901) project costs, and a $2.7 million decrease in development costs associated with abaloparatide-TD. This decrease was partially offset by a $9.1 million increase in compensation expense, including stock-based compensation, due to an increase in headcount, including the hiring of the medical science liaisons to support the U.S. launch of TYMLOS.
Selling, general, and administrative expense for the six months ended June 30, 2017, was $88.2 million compared to $30.8 million for the six months ended June 30, 2016, an increase of $57.4 million, or 186%. This increase was primarily the result of an increase of approximately $17.9 million in professional fees and support costs during the six months ended June 30, 2017, including the costs associated with increasing headcount and preparing for the commercialization of TYMLOS in the United States. This increase was also driven by a $34.2 million increase in compensation expense, including stock-based compensation, due to an increase in headcount, particularly the sales force and other support functions necessary to launch TYMLOS in the U.S. and for general purposes.
As of June 30, 2017, Radius had $215 million in cash, cash equivalents and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of June 30, 2017, we believe that, prior to the consideration of proceeds from partnering and/or collaboration activities, we have sufficient capital to fund our development plans, U.S. commercial and other operational activities for not less than twelve months from the date of this press release.