On May 7, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the first quarter ended March 31, 2021 (Press release, Radius, MAY 7, 2021, View Source [SID1234579464]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The following are key components of Q1, 2021 performance:

Q1, 2021 FINANCIAL HIGHLIGHTS:

Total net revenue improved by 17% year-over-year: $56 million in 2021 vs. $48 million in 2020
TYMLOS U.S. product net revenue down 6% year-over-year: $45 million in 2021 vs. $48 million in 2020
Reduced unit volumes from inventory channel destocking plus volatility in patient activity as a result of Covid-19 during 2020; there was a partial offset from an increase in net price
TYMLOS U.S. new patient adds grew by 14% in Q1, 2021 vs. Q4, 2020
Strong cash balance: $115 million of cash, cash equivalents and marketable securities as of 3/31/2021
Strategic and proactive management of capital structure:
Completed $175 million financing transaction in March, 2021
Redeemed ~37% of aggregate principal amount of the existing 3.00% convertible notes
Eliminated potential future dilution by ~2 million shares (~4.9% of outstanding shares)
Improved financial flexibility with a more balanced mix of secured and unsecured tranches
Added cash to the balance sheet to enhance liquidity
BUSINESS HIGHLIGHTS:

Abaloparatide:

On May 1, 2021, Humana added TYMLOS to the formularies of its Medicare Advantage Plans
Impact #1: adds ~5 million beneficiaries, which moves Medicare Part D coverage from 83% to 91%
Impact #2: increases coverage for first line PMO patients with history of fracture from 77% to 78%
Q1 TYMLOS new patient prescribers: 42 of top 50 HCP’s are now orthopedic or specialist bone practices
New patient growth for this group (the 42) was 26% vs. 14% for total Q1 TYMLOS prescriber activity
Re-submission of abaloparatide to the EMA targeted to occur in Q4, 2021
TYMLOS Black Box Warning: FDA process ongoing with clarity expected in Q4, 2021
Submitted data from the histomorphometry study for inclusion in the abaloparatide label
Elacestrant:

EMERALD phase 3 trial with our partner, Menarini Group, remains on track for 2H, 2021 topline readout
RAD011:

Type C meeting with the FDA in June, 2021 for PWS phase 3 protocol review
RAD011 previous data to be presented at the PWSA/USA conference June 23-25, 2021
Additional orphan indications being assessed with 2H, 2021 timetable to finalize plan(s)
Hired Head of Science and Technology for CBD, cannabinoid derivatives, formulations and delivery
First Quarter 2021 Financial Results

Three Months Ended March 31, 2021

Net Loss
For the three months ended March 31, 2021, Radius reported a net loss of $15.7 million, or $0.34 per share, compared to a net loss of $37.7 million, or $0.81 per share, for the three months ended March 31, 2020.

For the three months ended March 31, 2021, non-GAAP adjusted net loss, was $8.6 million, or $0.18 per share, compared to non-GAAP adjusted net loss of $27.4 million, or $0.59 per share, for the three months ended March 31, 2020.

Revenue
For the three months ended March 31, 2021, TYMLOS net product revenues were $45.3 million compared to approximately $47.9 million for the three months ended March 31, 2020.

For the three months ended March 31, 2021, license revenue was $11.0 million. No license revenue was recognized for the three months ended March 31, 2020.

Costs and Expenses
For the three months ended March 31, 2021, research and development expense was $31.4 million compared to $39.0 million for the three months ended March 31, 2020, a decrease of $7.6 million, or 19%. This decrease was primarily driven by a decrease of $3.3 million in abaloparatide-TD program cost, a $4.8 million decrease in compensation expense, which is comprised of a $1.1 million decrease in compensation expense and $3.7 million of billed reimbursable expenses, and a $7.7 million decrease in elacestrant program costs, which is comprised of a $2.9 million increase in gross program expenses offset by $10.6 million of billed reimbursable expenses. These decreases were partially offset by a $5.3 million increase in abaloparatide-SC program costs and a $2.9 million increase in professional fees and other expenses.

For the three months ended March 31, 2021, selling, general and administrative expenses were $34.1 million compared to $36.4 million for the three months ended March 31, 2020, a decrease of $2.3 million, or 6%. This decrease was primarily the result of a $0.4 million decrease in travel and entertainment expenses, a $3.6 million decrease in compensation cost, and a $0.4 million decrease in other operating costs. These decreases were partially offset by a $1.9 million increase in professional support costs, and a $0.2 million increase in occupancy and depreciation costs

On May 7, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that has entered into exchange agreements with certain noteholders of the Company’s 4.50% Convertible Senior Notes due 2025 ("Notes") (Press release, Opko Health, MAY 7, 2021, View Source [SID1234579462]). The noteholders have agreed to exchange $55.42 million of the Company’s outstanding 2025 Notes for shares of the Company’s common stock.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The number of shares of common stock to be issued by the Company to the Noteholders will be determined based upon a volume-weighted-average-price per share of common stock, subject to a floor price of $3.50 per share, during a four-trading-day averaging period, commencing today. The Company has agreed to pay the Noteholders accrued and unpaid interest on the exchanged notes in cash.

As announced in February 2019, in connection with the Company’s original issuance of its $200.0 million of Notes, the Company entered into a share lending agreement with Jefferies Capital Services, LLC under which it issued 29.25 million shares of common stock to lend. The Company currently expects that, upon consummation of the exchange of the Notes with its noteholders, there will be a pro rata reduction in the outstanding borrowed shares of its common stock.

On May 7, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that its board of directors approved the separation of Organon & Co. (Organon), and declared a special dividend distribution of one-tenth of a share of Organon common stock for every Merck common share outstanding as of the close of business on May 17, 2021, the record date for the distribution (Press release, Merck & Co, MAY 7, 2021, View Source [SID1234579461]). The Company also announced that the U.S. Securities and Exchange Commission (SEC) has declared effective the Registration Statement on Form 10 filed by Organon. The Form 10 includes information regarding Organon’s business and strategy as well as details on the spinoff, which is expected to be completed on June 2, 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to announce the full details of Organon’s spinoff from Merck, commencing later this month. This spinoff will position Organon as a successful, independent, publicly traded company with a compelling portfolio of important medicines, particularly in women’s health," said Rob Davis, president, Merck. "Organon will have a significant impact on women’s health around the world, providing benefits to patients and shareholders alike."

Organon will not issue fractional shares of its common stock in the distribution. Instead, holders of Merck common shares will receive cash in lieu of any fractional shares of Organon common stock that they would otherwise be entitled to. Merck expects the special dividend of Organon stock will be distributed on June 2, 2021.

There is no current market for Organon common stock. The New York Stock Exchange (NYSE) has authorized the listing of Organon common stock under the symbol "OGN". Organon has been advised that trading in its common stock is expected to begin on a "when issued" basis on May 14, 2021, under the symbol "OGN.WI." "When issued" trading of Organon common stock will continue until Merck pays the special dividend distribution of Organon common stock on June 2, 2021. Organon "when issued" trades are expected to settle after June 2, 2021, with shares of Organon as a standalone company.

Beginning on May 14, 2021, and continuing through June 2, 2021, Merck expects that common shares of Merck will trade in two markets on the NYSE: "regular-way" under the symbol "MRK" and in the "ex-distribution" market under the symbol "MRK.WI." Merck shares trading under "MRK" will carry the right to receive shares of Organon through the special dividend distribution. Merck shares trading under "MRK.WI" will not carry the right to receive shares of Organon through the special dividend distribution.

Merck shareholders who sell their shares in the "regular-way" market on or before June 2, 2021, will also be selling their entitlement to receive the Organon special dividend distribution of Organon common stock. Merck shareholders are encouraged to consult with their financial advisors regarding the specific consequences of selling Merck common shares on or before June 2, 2021.

On June 3, 2021, regular-way trading will commence on the NYSE for Organon under the symbol "OGN" and will continue for Merck under the symbol "MRK."

On May 7, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that Mr Christian Hogg, Chief Executive Officer of HUTCHMED, will participate in a virtual fireside chat at the Bank of America 2021 Health Care Conference on Tuesday, May 11, 2021 at 8:00 a.m. Eastern Daylight Time (EDT) (Press release, Hutchison China MediTech, MAY 7, 2021, View Source [SID1234579459]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The discussion will be webcast live and can be accessed at www.hutch-med.com/event. Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter for approximately 90 days.

Members of the senior management team will also attend virtual one-on-one meetings at the Bank of America Health Care Conference, as well as during the following other conferences:

●MS Virtual Asia Healthcare Conference from Thursday to Friday, May 13 to 14, 2021;

●Jefferies Virtual Global Healthcare Conference from Tuesday to Friday, June 1 to 4, 2021;

●Citi Pan-Asia Regional Investor Conference from Wednesday to Friday, June 2 to 4, 2021; and

● Goldman Sachs Global Healthcare Conference Webcast from Tuesday to Friday, June 8 to 11, 2021.

On May 7, 2021 Genmab A/S (Nasdaq: GMAB) reported In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) made by managerial employees and their closely associated persons (Press release, Genmab, MAY 7, 2021, View Source [SID1234579458]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab shares by the company’s managerial employees and their closely associated persons.

The sale of shares by Jan van de Winkel is partly to honor tax obligations arising out of his participation in Genmab A/S’ equity program. The sale of shares will take Jan van de Winkel’s personal holding of shares in Genmab A/S from 645,460 to 610,460 shares.