On November 5, 2019 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial and operating results for the third quarter ended September 30, 2019 and provided a strategic business update (Press release, Radius, NOV 5, 2019, View Source [SID1234550338]).

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Radius remains confident TYMLOS will become the anabolic market leader (based on TRx2) in 2020. In line with the Company’s goal of obtaining majority share in new patients, TYMLOS has been capturing half of new patient starts with an average 50% NBRx market share in October. Effective January 1, 2020, TYMLOS coverage will expand to approximately 290 million U.S. insured lives, representing approximately 99% of U.S. commercial and 79% of Medicare insured lives.

Radius is committed to transforming the use of anabolics to meet the unmet needs of high risk osteoporosis patients with the development and potential launch of abaloparatide-transdermal patch (abaloparatide-patch).

Radius will build on its strong scientific foundation and successful commercial franchise in osteoporosis to accelerate its growth and sharpen its strategic focus in targeted endocrine diseases. Radius will selectively evaluate in-licensing and partnership opportunities to expand its clinical pipeline and commercial assets in high potential targeted endocrine diseases.

In oncology, Radius continues to enroll patients in its EMERALD Phase 3 monotherapy study of elacestrant with completion of recruitment targeted in the third quarter of 2020. Given its focus on bone health and targeted endocrine diseases, the Company is considering all strategic options for its oncology assets to maximize their potential. The value of Radius’ oncology assets is expected to be most effectively realized by an oncology focused company with strong capabilities in this area. Radius does not plan to initiate further clinical development for elacestrant or RAD140 beyond the ongoing EMERALD study.

New Patients to Brand, NBRx PMOT. Source: IQVIA

Total Market Share, TRx PMOT. Source: IQVIA

"I am very pleased with our continued strong performance with TYMLOS. We are on a path to make TYMLOS the treatment of choice for high risk postmenopausal osteoporosis patients and shift the treatment paradigm with the patch," said Jesper Hoeiland, Chief Executive Officer of Radius. "With our refined strategy, we are excited to refocus our future by building on our core strengths and allocating resources efficiently to bring new and innovative medicines to patients and maximize opportunities for our business and shareholders."

TYMLOS (abaloparatide) injection

Third quarter 2019 U.S. net sales of TYMLOS were $47 million, a 69% increase from the third quarter of 2018. The anabolic market grew 4% in the third quarter of 2019 as compared to the third quarter of 2018.

Radius continued increasing its market share with TYMLOS capturing, on average, 38% of the U.S. anabolic osteoporosis market (based on Patient Months on Therapy, TRx PMOT) in the third quarter. In October 2019, TYMLOS achieved an average 50% NBRx share and its total market TRx share further increased to 40%.

After decisions from Aetna, Cigna and others, 2020 Medicare Part D coverage for TYMLOS will increase from 67% to 79% of those enrolled in Medicare Part D plans in the U.S. Effective January 1, 2020, TYMLOS is expected to be covered for approximately 290 million U.S. insured lives, representing approximately 99% of U.S. commercial and 79% of Medicare insured lives.

Pipeline Highlights

Abaloparatide-Patch

The wearABLe Phase 3 study which was initiated in August is now open for enrollment at more than 60 clinical sites in the U.S. reflecting strong interest from investigators. The ramp-up in patient enrollment has been slower than expected due to a higher than anticipated screen failure rate. A revised enrollment plan is being implemented that includes identified measures to improve site recruitment efforts, including adding sites outside the U.S. 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 with a majority of sites open and activated. Radius expects to complete patient recruitment in the third quarter of 2020.

Financial Highlights and Guidance

In the third quarter of 2019, TYMLOS gross profit covered the Company’s selling, general and administrative and internal research and development expenses and started partially funding the clinical pipeline projects.

Radius increased its full-year 2019 financial guidance for TYMLOS U.S. net revenues to $168 to $172 million (from $165 to $170 million) and its guidance for year-end cash, cash equivalents and investments balance to over $130 million (from $120 million).

Following an expanded formulary coverage in 2020 and increase in manufacturer reimbursement during the Medicare Part D coverage gap, the net price for TYMLOS is expected to remain flat in FY 2020 versus FY 2019.

Anticipated Milestones in Q4 2019

Elacestrant

Advance recruitment in Phase 3 EMERALD monotherapy study

TYMLOS/Financial

Grow full-year TYMLOS U.S. net sales to between $168 to $172 million

Deliver greater than $130 million cash, cash equivalents and investments balance at year-end

Expected Radius Presentations at Upcoming Conferences in Q4 2019

On November 21, 2019, the Company will present and host one-on-one meetings at the Jefferies 2019 London Healthcare Conference in London, UK.

On December 11, 2019, the Company will host one-on-one meetings at the Citi Global Healthcare Conference in New York, NY.

On December 12, 2019, the Company will host one-on-one meetings at Jefferies Denver Summit in Denver, CO.

Third Quarter 2019 Financial Results

Three Months Ended September 30, 2019

For the three months ended September 30, 2019, Radius reported a net loss of $30.0 million, or $0.65 per share, compared to a net loss of $49.8 million, or $1.09 per share, for the three months ended September 30, 2018.

For the three months ended September 30, 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 $20.4 million, or $0.44 per share, compared to non-GAAP adjusted net loss of $38.3 million, or $0.84 per share, for the three months ended September 30, 2018.

For the three months ended September 30, 2019 we recorded approximately $46.8 million of net product revenue compared to $27.6 million for the three months ended September 30, 2018.

For the three months ended September 30, 2019, research and development expense was $31.8 million compared to $26.8 million for the three months ended September 30, 2018, an increase of $5.0 million, or 19%. This increase was primarily driven by a $3.5 million increase in abaloparatide-patch program costs, a $2.0 million increase in elacestrant project costs, a $0.7 million increase in professional support costs, a $0.6 million increase in abaloparatide-SC program costs, and a $0.4 million increase in occupancy costs. These increases were partially offset by a $0.4 million decrease in RAD140 program costs and a $1.8 million decrease in compensation expense.

For the three months ended September 30, 2019, selling, general and administrative expense was $35.6 million compared to $43.7 million for the three months ended September 30, 2018, a decrease of $8.0 million, or 18%. This decrease was primarily the result of a $4.6 million decrease in professional support costs, a $2.1 million decrease in compensation related expenses attributed to a decrease in headcount from 384 selling, general, and administrative employees as of September 30, 2018 to 286 selling, general, and administrative employees as of September 30, 2019, a $0.9 million decrease in other operating costs, and a $0.5 million decrease in occupancy and depreciation costs. These decreases were partially offset by a $0.1 million increase in travel and entertainment expenses.

Nine Months Ended September 30, 2019

For the nine months ended September 30, 2019, Radius reported a net loss of $108.3 million, or $2.36 per share, compared to a net loss of $180.2 million, or $3.98 per share, for the nine months ended September 30, 2018.

For the nine months ended September 30, 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 $77.6 million, or $1.69 per share, compared to non-GAAP adjusted net loss of $133.0 million, or $2.94 per share, for the nine months ended September, 2018.

For the nine months ended September 30, 2019 we recorded approximately $117.7 million of net product revenue compared to $64.8 million for the nine months ended September 30, 2018.

For the nine months ended September 30, 2019, research and development expense was $82.2 million compared to $76.0 million for the nine months ended September 30, 2018, an increase of $6.3 million, or 8%. This increase was primarily driven by a $10.4 million increase in abaloparatide-patch project costs, a $4.4 million increase in elacestrant program costs, a $1.5 million increase in abaloparatide-SC program costs, and $0.5 million increase in professional and support fees. These increases were partially offset by a $1.7 million decrease in RAD140 program costs, a $0.2 million decrease in occupancy and depreciation costs, a $0.1 million decrease in travel and entertainment expenses, a $0.1 million decrease in other operating costs, and a $8.4 million decrease in compensation and personnel costs due to decreases in stock compensation, severance, temporary services of consultants, and headcount.

For the nine months ended September 30, 2019, selling, general and administrative expense was $116.9 million compared to $140.3 million for the nine months ended September 30, 2018, a decrease of $23.3 million, or 17%. This decrease was primarily the result of a $13.0 million decrease in compensation related to a decrease in headcount from 384 selling, general, and administrative employees as of September 30, 2018 to 286 selling, general, and administrative employees as of September 30, 2019, a $5.5 million decrease in professional support fees, a $2.7 million decrease in travel and entertainment related costs, a $1.8 million decrease in other operating costs, and a $0.3 decrease in occupancy and depreciation costs.

As of September 30, 2019, Radius had $168.7 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of September 30, 2019, 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.

Webcast and Conference Call

In connection with today’s reporting of Third Quarter 2019 Financial Results, Radius will host a conference call and live audio webcast at 4:30 p.m. ET today, November 5, 2019, to review the commercial, research and development, and financial highlights and provide a Company update.

Conference Call Information:

Date: November 5, 2019

Time: 4:30 p.m. ET

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

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

Conference ID: 2490257

Live webcast:
View Source

For those unable to participate in the conference call or webcast, a replay will be available on Tuesday, November 5, 2019 at 7:30 p.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 2490257.

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.

On November 5, 2019 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Principia Biopharma, NOV 5, 2019, View Source [SID1234550337]).

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"With our focus on execution, we made significant progress on our clinical programs during the third quarter. We also recently reported preliminary positive data from our ongoing Phase 2 pemphigus and Phase 1/2 immune thrombocytopenia (ITP) clinical trials with PRN1008. Following these announcements, we were able to execute a successful follow-on offering of common stock with gross proceeds of $241.5 million," said Martin Babler, president and chief executive officer of Principia Biopharma. "We are also pleased industry veteran Shawn Tomasello joined our Board of Directors as she brings an extensive track record in commercializing novel pharmaceutical products."

Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $161.2 million as of September 30, 2019, compared to $180.6 million as of December 31, 2018. In addition, in October 2019, we completed a follow-on public offering which resulted in net proceeds of $226.5 million after deducting underwriting discounts and commissions and estimated offering expenses.

Revenues: We did not recognize any collaboration revenue for the three months ended September 30, 2019, compared to $18.6 million for the same period in 2018. The $18.6 million recognized for the three months ended September 30, 2018 consisted of a portion of upfront fees and milestone payments from our Sanofi and AbbVie collaborations.

R&D Expenses: Total research and development expenses were $18.4 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.8 million, compared to $9.2 million for the same period in 2018, including stock-based compensation expense of $0.3 million. The increase in total research and development expenses was mainly driven by an increase in personnel-related expenses as we build out our R&D team, and an increase in PRN1008 program costs, due to the initiation of a global Phase 3 trial in patients with pemphigus in November 2018 and certain manufacturing campaigns to supply drug products for our PRN1008 clinical trials.

G&A Expenses: General and administrative expenses were $5.0 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.5 million, compared to $2.9 million for the same period in 2018, including stock-based compensation expense of $0.4 million. The increase in total general and administrative expenses was primarily driven by increased personnel-related expenses and headcount costs related to operating as a public company.

Net Income (Loss): For the three months ended September 30, 2019, net loss was $22.3 million compared to a net income of $6.7 million for the same period in 2018, as we did not recognize any collaboration revenue for the three months ended September 30, 2019.

On November 5, 2019 Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, reported it will present preclinical research findings during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting on its lead allogeneic product candidate, P-BMCA-ALLO1, in multiple myeloma (Press release, Poseida Therapeutics, NOV 5, 2019, View Source [SID1234550336]).

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At SITC (Free SITC Whitepaper) 2019, preclinical results will highlight the potential of Poseida’s gene engineering technologies in addressing current challenges with earlier generation autologous CAR-T therapies. Poseida leverages its proprietary piggyBac DNA Modification System in combination with Cas-CLOVER gene editing technology to create P-BCMA-ALLO1, an off-the-shelf allogeneic CAR-T cell product candidate. These technologies enable the development of allogeneic CAR-T therapies with a variety of benefits to patients and the medical community including greater safety and duration of response, as well as manufacturing and patient cost savings.

Poseida will present the following research at SITC (Free SITC Whitepaper) 2019:

P-BCMA-ALLO1 – a Non-viral Allogeneic Anti-BCMA CAR-T Therapy with Potent Antitumor Function for the Treatment of Multiple Myeloma (Oral Presentation [O7, Annual Meeting Session 100]; November 7, 4:15 PM ET; Potomac Ballroom CD) which shows potent effector function in preclinical research indicating the need for rapid advancement into the clinic for the treatment of multiple myeloma.
"Broad adoption of earlier generation CAR-T therapies have been curtailed by serious safety concerns, limited duration of response and difficulty supporting access within the current healthcare system," said Eric Ostertag, M.D., Ph.D., chief executive officer of Poseida. "We are actively problem-solving to address these challenges and our new findings indicate that we are making progress with our allogeneic approach powered by our piggyBac DNA Modification System and Cas-CLOVER gene editing technology."

About P-BCMA-ALLO1

P-BCMA-ALLO1 is an allogeneic CAR-T therapy being developed by Poseida for multiple myeloma. It is designed to have the benefits of scale and administration efficiency that come from an allogeneic product. Poseida expects to file an IND for P-BCMA-ALLO1 in 2020. Approximately 32,110 people were diagnosed with multiple myeloma and 12,960 died from the condition in the United States in 2019.

On November 5, 2019 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported financial results for the three months ended September 30, 2019, and provided a corporate update (Press release, Portola Pharmaceuticals, NOV 5, 2019, View Source [SID1234550335]).

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"We delivered another quarter of strong Andexxa revenue in the U.S. and expanded our growth potential with our first sales of Ondexxya in Europe. The use of Factor Xa inhibitors in both markets continues to grow, driving the underlying market opportunity for Andexxa/Ondexxya and long-term value of Portola," said Scott Garland, Portola’s president and chief executive officer. "Looking forward, we will continue to focus on exceptional launch execution, leveraging external support from health authorities and favorable society guidelines, and building the clinical evidence and awareness of Andexxa. In addition, we remain on track to initiate a registration trial for cerdulatinib in early 2020 and will present updated data at the ASH (Free ASH Whitepaper) meeting in December."
Product Sales:

Total global revenues for the third quarter of 2019 were $36.8 million compared with $14.2 million for the third quarter of 2018. This includes $35.7 million in net product revenues from sales of Andexxa/Ondexxya [coagulation factor Xa (recombinant), inactivated-zhzo], $17,000 in revenues from Bevyxxa (betrixaban) sales and $1.1 million in collaboration and license revenues.

Net loss attributable to Portola, according to generally accepted accounting principles in the U.S. (GAAP) was $49.6 million, or $0.68 net loss per share for the third quarter of 2019, compared with a net loss of $71.3 million, or $1.08 net loss per share, for the same period in 2018.
Operating Expenses:
For the third quarter of 2019, compared to the same period in 2018:

Research and development (R&D) expenses decreased by $14.6 million, or 36.3%, primarily due to the manufacturing costs for Andexxa Gen 2 being capitalized and no longer flowing through R&D.

Selling, general and administrative (SG&A) expenses increased by $13.3 million, or 34.2%, due to commercial costs to support the Andexxa launch including the expansion of the field sales teams and launch preparations in Europe.

Cost of Sales (COS) were $2.7 million for the third quarter of 2019, compared to $4.3 million for the same period in 2018. This decrease was primarily due to transition from our Gen 1 to our Gen 2 Andexxa product.

These amounts on a GAAP and non-GAAP basis are reflected in the table below. A table reflecting the reconciliation of GAAP to non-GAAP amounts is included at the end of this release.

Cash, Cash Equivalents and Investments:

Cash, cash equivalents and investments at September 30, 2019, totaled $476.8 million, compared with $317.0 million as of December 31, 2018. During the third quarter, the Company added net proceeds of $245 million in connection with the follow on offering of the Company’s common stock.
Recent Achievements and Events

Ondexxya launched with $2.7 million of European net sales in the third quarter of 2019.

Andexxa added to the Veteran’s Health Administration national formulary, making access to 170 VA hospitals across the U.S. possible.

Andexxa recommended as first line therapy by The American Academy of Family Physicians (AAFP).

Centers for Medicare and Medicaid Services (CMS) New Technology Add-on Payment (NTAP) reimbursement for Andexxa increased from 50% to 65% effective on October 1, 2019.

Presented sub-analysis of ANNEXA-4 study at the American College of Gastroenterology annual meeting, highlighting the efficacy and safety of Andexxa in Factor Xa patients with acute gastrointestinal bleeding, which demonstrated excellent or good hemostasis achieved in 82% of evaluable patients.

Presented in vitro data at International Society of Thrombosis and Hemostasis annual meeting, demonstrating that four-factor prothrombin complex concentrate (4F-PCC) does not appear to have an effect on the inhibition of thrombin generation by apixaban or rivaroxaban unless the Factor Xa inhibitor concentration was less than 75 ng/mL. In contrast, data from the same thrombin generation assay demonstrated that Andexxa fully corrected the inhibition of thrombin generation by apixaban and rivaroxaban across a broad range of inhibitor concentrations.

Net proceeds of $245 million raised in a public offering of the Company’s common stock.
Planned Upcoming Milestones

Continue launch of Ondexxya in a select group of high-potential European countries with significant usage of Factor Xa inhibitors and supportive access and reimbursement.

Plan to initiate an urgent surgery study for Andexxa by year end or in early 2020.

Plan to launch a cerdulatinib registration study in peripheral T-cell lymphoma (PTCL) in early 2020.

Multiple abstracts related to Andexxa and cerdulatinib accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December.
Analyst and Investor Meeting
Portola will host an analyst and investor meeting focused on Andexxa on Thursday, November 14, 2019, from 8:00 to 10:30 a.m. ET in New York. Seating is limited to those who RSVP. Please contact [email protected] for an invitation. The event will also be webcast live and can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for one year following the date of the event.

Conference Call Details
Portola will host a conference call today, Tuesday, November 5, 2019, at 4:30 p.m. ET, during which time management will discuss the third quarter 2019 financial results, updates on the U.S. and European launch of Andexxa/Ondexxya, and its operations. The live call can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 2980632. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.
Use of Non-GAAP Financial Measures
This press release and the reconciliation table included herein include non-GAAP R&D expenses. The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When viewed in conjunction with GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those that the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation of GAAP to non-GAAP financial measures is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Financial Informati

On November 5, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will present phase 1 dose-escalation monotherapy data for PRS-343, a 4-1BB/HER2 bispecific for the treatment of HER2-positive solid tumors, in a late-breaking oral presentation session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in National Harbor, Maryland (Press release, Pieris Pharmaceuticals, NOV 5, 2019, View Source [SID1234550334]).

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"We are pleased to have had our abstract accepted as one of the few late-breaking podium presentations at the conference, and we look forward to sharing an updated dataset for the program on November 9th, including safety, PK, biomarker, and clinical response data for patients enrolled in the highest dose cohorts," said Stephen S. Yoder, President and Chief Executive Officer of Pieris.

Presentation Details

Title: A Phase 1 Dose Escalation Study of PRS-343, a HER2/4-1BB Bispecific Molecule, in Patients with HER2-positive Malignancies
Session: 304
Date/Time: Saturday, November 9, 2019, 11:50 AM EST
Location: Potomac Ballroom, Gaylord National Hotel & Convention Center in National Harbor, Maryland

The presentation will be made available on the publications section of the Company’s website at www.pieris.com.