On February 27, 2020 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the fourth quarter and full-year ended December 31, 2019 and provided a business update (Press release, Radius, FEB 27, 2020, View Source [SID1234554869]).

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"I am very pleased that TYMLOS exited 2019 with a December majority share of postmenopausal osteoporosis patients starting on anabolic therapy in the U.S. market. In 2020, we have three critical objectives: continue expanding our market share for TYMLOS, reach anabolic total market share leadership, and complete recruitment in our three pivotal Phase 3 studies," said Jesper Hoeiland, President and Chief Executive Officer of Radius.

TYMLOS (abaloparatide) injection

Fourth quarter 2019 U.S. net sales of TYMLOS were $55.7 million, a 19% increase over the prior quarter and 62% increase from the fourth quarter of 2018. Full-year 2019 U.S. net sales of TYMLOS were $173.3 million, a 75% increase over full-year 2018.

In 2019, TYMLOS captured, on average, 36% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT). In the fourth quarter of 2019, TYMLOS’ average U.S. anabolic market share rose to 41% and it achieved a 50% share of new anabolic patient starts. Radius remains confident TYMLOS will become the anabolic market leader (based on TRx2) in 2020.

TYMLOS is covered for approximately 290 million U.S. insured lives, 99% of Commercial and 83% of Medicare Part D insured lives. The Medicare Part D coverage has increased 16 percentage

US Anabolic Osteoporosis Market; New Patients to Brand: NBRx PMOT. (Source: IQVIA)

Total Market Share, TRx PMOT. Source: IQVIA

points from 2019 due to decisions from Aetna, CIGNA and Anthem to cover TYMLOS for their Medicare Part D beneficiaries in 2020.

Pipeline Highlights

Abaloparatide-SC

Radius expects to complete recruitment of the ATOM Phase 3 Study, which is assessing the efficacy and safety of abaloparatide-SC in male osteoporosis, this year and report top-line data in the second half of 2021.

Abaloparatide-Patch

The wearABLe Phase 3 study is open for enrollment at more than 60 clinical sites in the U.S., reflecting strong interest from investigators. The Company has implemented a revised enrollment plan, added more clinical sites in the U.S., and made progress filing regulatory submissions to expand sites outside the U.S. The screen failure rate which started higher than expected at the initiation of the study is improving, driven by higher screening success at targeted bone specialty sites.

Radius expects to report top-line data from the study in the second half of 2021.

Elacestrant

The EMERALD Phase 3 study is currently enrolling patients in multiple countries and is on track to complete recruitment of 466 patients in the third quarter of 2020.

Financial Highlights and Guidance

With 2019 TYMLOS U.S. net sales reaching $173 million, Radius exceeded its 2019 full-year net sales guidance of $168 to $172 million. Radius closed 2019 with $161 million cash, cash equivalents and investments balance, driven by productivity initiatives, in line with its year-end guidance to exceed $130 million.

For 2020, Radius expects full-year TYMLOS U.S. net revenue to be between $220 and $235 million and its full-year cash burn to be below $80 million.

On January 10, 2020, the Company entered into a secured, non-dilutive credit facility for up to an aggregate amount of $95 million, comprised of a term loan of up to $55 million and a $20 million revolving credit facility based on accounts receivable and inventory, with the right, subject to certain conditions, to increase the revolver by $20 million. The credit facility has a maturity date of June 1, 2024. This funding is intended to support pre-launch activities for abaloparatide-patch, evaluation of opportunities in targeted endocrine diseases, and to strengthen the Company’s minimum cash balance toward profitability.

Over the next three years (2020-2022) Radius expects TYMLOS revenue to grow at a greater than 20% compound annual growth rate and the Company to achieve profitability.

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 $220 and $235 million

Capture anabolic TRx market leadership in 2H 2020

Expected Radius Presentations at Upcoming Conferences in Q1 2020

On February 27, 2020, the Company will present and host one-on-one meetings at the 9th Annual SVB Leerink Global Healthcare Conference in New York.

On March 4, 2020, the Company will present and host one-on-one meetings at Cowen 40th Annual Health Care Conference in Boston.

On March 17, 2020, the Company will host one-on-one meetings at the Morgan Stanley Healthcare Corporate Access Day in Boston.

Fourth Quarter and Full-Year 2019 Financial Results

Three months ended December 31, 2019

For the three months ended December 31, 2019, Radius reported a net loss of $24.7 million, or $0.54 per share, compared to a net loss of $41.1 million, or $0.90 per share, for the three months ended December 31, 2018.

For the three months ended December 31, 2019, 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 $13.3 million, or $0.29 per share, compared to non-GAAP adjusted net loss of $30.0 million, or $0.66 per share, for the three months ended December 31, 2018.

For the three months ended December 31, 2019 we recorded approximately $55.7 million of net product revenue compared to $34.4 million for the three months ended December 31, 2018.

For the three months ended December 31, 2019, research and development expense was $34.5 million compared to $23.9 million for the three months ended December 31, 2018, an increase of $10.6 million, or 44%. This increase was primarily driven by increases in elacestrant project costs and abaloparatide-patch project costs of $5.4 million and $5.7 million, respectively.

For the three months ended December 31, 2019, selling, general and administrative expense was $35.7 million compared to $43.9 million for the three months ended December 31, 2018, a decrease of $8.2 million, or 19%. This decrease was primarily the result of a $4.4 million decrease in professional fees, a $2.3 million decrease in compensation and travel costs, and a $0.9 million decrease in other operating costs.

Twelve months Ended December 31, 2019

For the twelve months ended December 31, 2019, Radius reported a net loss of $133.0 million, or $2.89 per share, compared to a net loss of $221.4 million, or $4.88 per share, for the twelve months ended December 31, 2018.

For the twelve months ended December 31, 2019, non-GAAP adjusted net loss, which excludes expenses related to stock-based compensation, restructuring plans, depreciation, non-cash interest obligations under debt obligations, impairment of operating lease right of use assets, and amortization of intangible assets, was $90.9 million, or $1.98 per share, compared to non-GAAP adjusted net loss of $163.0 million, or $3.59 per share, for the twelve months ended December 31, 2018.

For the twelve months ended December 31, 2019 we recorded approximately $173.3 million of net product revenue compared to $99.2 million for the twelve months ended December 31, 2018.

For the twelve months ended December 31, 2019, research and development expense was $116.8 million, as compared to $99.9 million for the twelve months ended December 31, 2018, an increase of $16.8 million, or 17%. This increase was primarily a result of an increase of $16.1 million in program spending for the abaloparatide-patch program, a $9.8 million increase in program spending for elacestrant research, a $1.7 million increase in professional services, and $0.6 million increase in program spending for the abaloparatide-SC program. These increases were partially offset by a $1.9 million decrease in program spending for RAD-140 program, a $0.3 million decrease in R&D support costs as well as an $9.2 million decrease in compensation related costs.

For the twelve months ended December 31, 2019, selling, general, and administrative expense was $152.7 million, as compared to $184.2 million for the twelve months ended December 31, 2018, a decrease of $31.5 million, or 17%. This decrease was primarily due to a $10.0 million decrease in professional fees related to commercial operations and general and administrative activities, a $17.9 million decrease in compensation and travel entertainment costs and a $3.6 million decrease in other costs.

As of December 31, 2019, Radius had $161.5 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of December 31, 2019 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.

Common stock, $0.0001 par value; 200,000,000 shares authorized, 46,189,870 shares and 45,563,693 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively

Webcast and Conference Call

In connection with today’s reporting of Fourth Quarter and Full Year 2019 Financial Results, Radius will host a conference call and live audio webcast at 8:00 a.m. ET today, February 27, 2020, to review the commercial, research and development, and financial highlights and provide a Company update.

Conference Call Information:

Date: February 27, 2020

Time: 8:00 a.m. ET

Domestic Dial-in Number: (866) 323-7965

International Dial-in Number: (346) 406-0961

Conference ID: 2998060

Live webcast: View Source

A live audio webcast of the call can be accessed from the Investors section of the Company’s website, www.radiuspharm.com. The full text of the announcement and financial results will also be available on the Company’s website.

For those unable to participate in the conference call or webcast, a replay will be available on Thursday, February 27, 2020 at 11:00 a.m. ET and will be archived on the Company’s website for 90 days. To access the replay, dial (855) 859-2056 for U.S. or (404) 537-3406 for International, using conference ID number 2998060.

On February 27, 2020 Boehringer Ingelheim and Trutino Biosciences reported they have entered into a research collaboration and worldwide licensing agreement based on Trutino’s innovative On-Demand-Cytokine (ODC) platform (Press release, Boehringer Ingelheim, FEB 27, 2020, View Source [SID1234554896]). Under the terms of strategic alliance, Boehringer Ingelheim gains access to Trutino’s ODC platform technology for the generation and development of up to three new ODC candidates. This new collaboration combines Boehringer Ingelheim’s long-term strategy to provide first-in-class, breakthrough therapies for cancer patients with Trutino’s unique knowledge and expertise in increasing the safety and efficacy of cytokine therapies.

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"Developing a strong and innovative cytokine therapeutic program as an additional component of our cancer immunology portfolio, demonstrates how we are ‘Taking Cancer On,’ and provides a high potential combination partner for our existing cancer vaccine, oncolytic virus, T cell engager and myeloid-targeting therapeutics portfolio," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head, Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim. "We are very pleased to partner with Trutino and harness the potential of their innovative scientific platform to develop treatment breakthroughs that will transform the lives of cancer patients."

Trutino’s ODC platform masks the activity of cytokines until they reach the tumor site and become fully activated, sparing systemic exposure and potentially leading to a higher margin of safety and greater efficacy than conventional cytokine treatments. Trutino will generate the new ODC molecules and carry out preclinical validation, handing over development to Boehringer Ingelheim for late pre-clinical testing through the rest of development.

"We are excited to embark on this partnership with Boehringer Ingelheim, a leader in cancer immunology, to advance cytokine therapeutic options that address the unmet medical needs of patients worldwide," said Phillip Kim, Ph.D., MBA, Founder and CEO of Trutino Biosciences. "Boehringer Ingelheim has a deep commitment to innovative scientific approaches and is a leader in bringing novel cancer therapies to market. This global partnership validates the broad potential of our proprietary ODC platform to create safer and more effective cytokine therapies that can be delivered systemically and activated locally. Together, we can rapidly develop a new generation of cytokine therapies to address critical unmet need in oncology."

Trutino’s clinical potential was initially recognized by Boehringer Ingelheim through its grass roots programs, including the ‘BI Innovation Prize,’ where the ODC platform technology was an early-stage standout in the 2019 program held in San Diego. Launched in 2015, the grass roots programs comprise of ‘BI Office Hours,’ ‘BI Academy’ and the ‘BI Innovation Prize.’ Through Office Hours, Boehringer Ingelheim has provided over 200 early-stage companies in the life-sciences community with mentoring and direct access to relevant expertise and industry perspective from senior leaders within the company. In partnership with BioLabs in Boston, New York and San Diego, Boehringer Ingelheim has awarded numerous entrepreneurs with free lab space through the ‘Golden Ticket’ program. As a company dedicated to improving health and quality of life, these programs give Boehringer Ingelheim the opportunity to lend expertise to the innovation community and offer guidance around the science to help enable ideas to deliver the next breakthroughs.

The partnership with Trutino will strengthen Boehringer Ingelheim’s next generation immune oncology portfolio, which combines cancer vaccines, oncolytic viruses, T Cell engagers and myeloid targeting platforms with the aim of making "cold" tumors that are invisible to the immune system "hot" to rally the immune system against the tumor. Under the terms of the agreement, Boehringer Ingelheim will provide an upfront payment, near-term pre-clinical milestone payments and clinical, regulatory and commercial milestone payments, including royalties on future product sales.

On february 27, 2020 Morphic Therapeutic (NASDAQ: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the full year 2019 (Press release, Morphic Therapeutic, FEB 27, 2020, View Source [SID1234554913]).

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2019 and Recent Corporate Highlights:

Completed a successful Initial Public Offering with gross proceeds of $103.5 million

Announced a partnership with Janssen for the discovery of novel oral integrin inhibitors

Presented preclinical data supporting MORF-057 as an oral inhibitor candidate targeting α4β7; IND expected in mid-2020

Advanced development of MORF-720 in IPF with AbbVie, IND anticipated by year-end 2020

Year-end cash, cash equivalents and marketable securities of $237.0 million expected to fund operating expenses and capital expenditures requirements at least through 2022

"Morphic Therapeutic made tremendous progress in our mission to develop oral integrin therapeutics during 2019 across both the developmental and financial aspects of our business. Notably, we completed a successful IPO in July 2019 that provided us with substantial resources to advance our proprietary pipeline of integrin-targeted candidates. Further, we struck an important partnership with Janssen that supports the exploration of a broader scope of integrin drug targets," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "Moving forward, Morphic began 2020 with important milestones that signal the near-term initiation of clinical trials of our development pipeline. We recently presented preclinical data at ECCO 2020 supporting MORF-057’s mechanism of action as being analogous to that of approved therapeutic vedolizumab, with a potentially superior target interaction profile and oral administration."

Financial Results for the Full Year 2019

Net loss for the year ended December 31, 2019, was $43.3 million or $2.69 per share compared to a net loss of $23.8 million or $22.28 per share for the year ended December 31, 2018.

Revenue was $17.0 million for the year ended December 31, 2019 compared to $3.4 million for the year ended December 31, 2018. The increase was due to collaboration agreements signed with AbbVie in October 2018 and Janssen in February 2019.

Research and development expenses were $53.7 million for the year ended December 31, 2019 as compared to $22.6 million for the year ended December 31, 2018. The increase was primarily attributable to higher development and manufacturing costs associated with our lead product candidates, MORF-057 and MORF-720, as well as increased personnel-related costs to support continued progress with the company’s pipeline.

General and administrative expenses were $10.2 million for the year ended December 31, 2019, compared to $5.4 million for the year ended December 31, 2018. The increase year-over-year was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and Morphic’s costs to operate as a public company.

As of December 31, 2019, Morphic had cash, cash equivalents and marketable securities of $237.0 million, compared to $185.9 million as of December 31, 2018. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2019, will be sufficient to fund operating expenses and capital expenditure requirements at least through 2022.

On February 27, 2020 Amgen (NASDAQ:AMGN) reported that it will present at the Cowen 40th Annual Healthcare Conference at 11:20 a.m. ET on Monday, March 2, 2020 in Boston (Press release, Amgen, FEB 27, 2020, View Source [SID1234554932]). Peter H. Griffith, executive vice president and chief financial officer, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will present. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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On February 27, 2020 Apexigen, Inc., a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, reported that Xiaodong Yang, M.D., Ph.D., President and Chief Executive Officer, will present at the following upcoming investor conferences (Press release, Apexigen, FEB 27, 2020, View Source [SID1234554949]):

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Cowen’s 40th Annual Healthcare Conference
Tuesday, March 3, 2020 at 11:30 am ET in Boston, MA

Solebury Trout’s Spring 2020 Private Company Showcase
Thursday, April 2, 2020 in New York, NY