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Novocure Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Company Update

On February 25, 2021 Novocure (NASDAQ: NVCR) reported financial results for the quarter and full year ended December 31, 2020, highlighting revenue growth and financial strength as well as the advancement of the company’s clinical and product development programs (Press release, NovoCure, FEB 25, 2021, View Source [SID1234575680]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields.

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(1) Adjusted EBITDA is a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and share-based compensation.

(2) An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

(3) A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.

"Our track record of execution continued throughout 2020 with notable progress made in advancing our three overarching priorities: to drive commercial adoption; to carry out our clinical trial programs; and to deliver product innovations to optimize Tumor Treating Fields therapy," said William Doyle, Novocure’s Executive Chairman. "Despite the complexities posed by the COVID-19 pandemic, we generated nearly $500 million in net revenues and $20 million in net income in 2020. Our financial strength positions us well to invest strategically in science and technology to unleash the potential of the Tumor Treating Fields platform."

"As proud as we are of treating more than 18,000 patients to-date, we remain focused on extending the reach of Tumor Treating Fields therapy to many more cancer patients," added Asaf Danziger, Novocure’s Chief Executive Officer. "With multiple clinical trials expected to read out over the next few years, we believe we are just beginning to unlock our potential to impact oncology. Acceptance of our therapy continues to build within the global oncology community, which reinforces our commitment to our mission to extend survival in some of the most aggressive forms of cancer."

Fourth quarter 2020 financial update

For the quarter ended December 31, 2020, net revenues were $144.0 million, representing 45% growth compared to the fourth quarter 2019.

In the United States, net revenues totaled $97.7 million in the quarter ended December 31, 2020, representing 48% growth compared to the same period in 2019.
In Germany and other EMEA markets, net revenues totaled $33.8 million in the quarter ended December 31, 2020, representing 31% growth compared to the same period in 2019.
In Japan, net revenues totaled $7.9 million in the quarter ended December 31, 2020, representing 42% growth compared to the same period in 2019.
In Greater China, net revenues totaled $4.5 million in the quarter ended December 31, 2020, representing 132% growth compared to the same period in 2019.
For the three months ended December 31, 2020, the increases primarily resulted from an increase of 502 active patients in our active markets and an increase in the net revenues per active patient per month. The increase in net revenues per active patient per month primarily was driven by improving reimbursement approval rates in the U.S.

In the fourth quarter 2020, we recorded $9 million in revenues from Medicare fee-for-service beneficiaries billed under the coverage policy effective on September 1, 2019. We have gained a good understanding of how to ensure timely processing of Medicare claims and have sufficient experience to recognize approximately two-thirds of the expected contribution from Medicare beneficiaries. In the fourth quarter of 2020, we also recognized approximately $11 million in incremental net revenues compared to the first half of 2020 resulting from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage.

Cost of revenues for the three months ended December 31, 2020 was $28.1 million compared to $24.8 million for the same period in 2019, representing an increase of 14%. The increase in cost of revenues primarily was due to the cost of shipping arrays to a higher volume of commercial patients. Gross margin was 80% for the three months ended December 31, 2020 compared to 75% for the three months ended December 31, 2019. Gross margin continues to benefit from ongoing efficiency initiatives and increasing scale. Gross margin is also improved with revenue resulting from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries and tempered by product sales to Zai.

Research, development and clinical trials expenses for the three months ended December 31, 2020 were $44.0 million compared to $23.7 million for the same period in 2019, representing an increase of 85%. The increase primarily was due to increased investments in clinical trials and clinical administration personnel to advance and broaden our clinical development programs, preclinical and basic research to better understand the optimal use of Tumor Treating Fields, product development intended to optimize the delivery of Tumor Treating Fields therapy, and expanded medical affairs efforts to educate the clinical community.

We expect growth in our research and development to continue into 2021 as we work to advance our pipeline programs and increase acceptance of Tumor Treating Fields within the global oncology community. We balance our investments in research and development with our organizational capacity to effectively execute our strategic initiatives.

Sales and marketing expenses for the three months ended December 31, 2020 were $31.4 million compared to $26.8 million for the same period in 2019, representing an increase of 17%. This primarily was due to an increase in personnel and professional services costs to support our growing commercial business and reimbursement efforts and an increase in marketing expenses related to the launch of Optune Lua for MPM.

General and administrative expenses for the three months ended December 31, 2020 were $28.4 million compared to $23.7 million for the same period in 2019, representing an increase of 19%. This primarily was due to an increase in personnel costs, insurance premiums and professional services.

Net income for the three months ended December 31, 2020 was $4.9 million compared to net income of $4.3 million for the same period in 2019.

At December 31, 2020, we had $842.6 million in cash and cash equivalents and short-term investments, an increase of $516.5 million compared to $326.1 million at December 31, 2019. The increase in our cash, cash equivalents and short-term investments primarily was due to convertible notes issued, net cash provided by operating activities and the exercise of options.

Fourth quarter 2020 operating statistics

There were 3,411 active patients at December 31, 2020, representing 17% growth compared to December 31, 2019, and 1% growth compared to September 30, 2020.

In the United States, there were 2,193 active patients at December 31, 2020, representing 12% growth compared to December 31, 2019.
In Germany and other EMEA markets, there were 953 active patients at December 31, 2020, representing 25% growth compared to December 31, 2019.
In Japan, there were 265 active patients at December 31, 2020, representing 38% growth compared to December 31, 2019.
Additionally, 1,411 prescriptions were received in the quarter ended December 31, 2020, representing 2% growth compared to the same period in 2019, and a 3% increase compared to the quarter ended September 30, 2020. In the quarter ended December 31, 2020, 1,160 Optune prescriptions were written for patients with newly diagnosed glioblastoma.

In the United States, 962 prescriptions were received in the quarter ended December 31, 2020, representing a 4% decrease compared to the same period in 2019.
In Germany and other EMEA markets, 349 prescriptions were received in the quarter ended December 31, 2020, representing 22% growth compared to the same period in 2019.
In Japan, 100 prescriptions were received in the quarter ended December 31, 2020, representing 8% growth compared to the same period in 2019.
Fourth quarter 2020 non-U.S. GAAP measures

We also measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.

Adjusted EBITDA was $34.8 million for the three months ended December 31, 2020, an increase of $17.5 million, or 101%, from $17.3 million for the three months ended December 31, 2019. This improvement in fundamental financial performance was driven by net revenue growth coupled with an ongoing commitment to disciplined management of expenses.

Anticipated clinical milestones

Final data from phase 2 pilot HEPANOVA trial in advanced liver cancer (Q2 2021)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (Q3 2021)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (Q4 2021)
Final data from phase 2 pilot EF-31 trial in gastric cancer (2022)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Final data from phase 3 pivotal METIS trial in brain metastases (2022)
Final data from phase 2 pilot EF-33 trial with high-intensity arrays in recurrent glioblastoma (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2023)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2023)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2023)
Conference call details

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2020 financial results at 8 a.m. EST today, Thursday, February 25, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 3965899.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Xencor and UCLA Enter Collaboration to Discover and Develop Novel XmAb® Therapeutics

On February 25, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, and UCLA Technology Development Group (UCLA TDG) reported an agreement to develop novel therapeutic antibodies, pairing novel targets proposed by scientists at UCLA and utilizing Xencor’s modular suite of XmAb technology platforms (Press release, Xencor, FEB 25, 2021, View Source [SID1234575679]). Xencor and UCLA have established a streamlined framework to select promising biology, perform collaborative research and license intellectual property.

Xencor’s XmAb platforms are precisely engineered antibody Fc domains, which enable the creation of stable new protein structures, such as bispecific antibodies and engineered cytokines, or amplification of natural immune functions, such as extending circulating half-life or enhancing immune cell cytotoxicity. Xencor and its pharmaceutical partners are now advancing 20 clinical-stage XmAb-engineered drug candidates for the treatment of patients with life-threatening and debilitating diseases. Two of these antibodies have been approved by the U.S. FDA, one for the treatment of patients with rare blood disorders and the other for an aggressive form of non-Hodgkin lymphoma.

"The creation of exciting new therapeutic modalities requires advancing innovative biological concepts together with state-of-the-art molecular platforms to build best-in-class biologics," said John Desjarlais, Ph.D., senior vice president and chief scientific officer at Xencor. "The inherent modularity and stability provided by our XmAb platforms, and our ability to precisely tune a molecule’s target-binding capability, opens the door to evaluate the clinical potential of biology that was previously considered intractable. We look forward to collaborating with UCLA’s investigators to translate their biological insights into potential medicines."

The UCLA Technology Development Group, the campus’ gateway to innovation, research and entrepreneurship, will work with faculty to propose potential antibody drug candidates. For selected candidates, the collaborators will use a framework with predefined terms to enter sponsored research agreements and potential license agreements.

"Many revolutionary medical breakthroughs discovered by UCLA’s world-class investigators have vastly improved the care of patients, including engineered T cells, therapeutic antibodies and small molecules that are now approved to treat many types of cancer," said Amir Naiberg, Associate Vice Chancellor, Chief Executive Officer and President of the UCLA Technology Development Group.

"With this collaboration, we aim to accelerate the development of potential new biologic medicines, leveraging Xencor’s protein engineering technologies and expertise and the ongoing scientific discoveries and insights into disease biology made at UCLA, with the ultimate goal to improve patient outcomes and quality of life," added Mark A. Wisniewski, Senior Director of Biopharmaceuticals at UCLA TDG.

Theratechnologies Announces Fourth-Quarter And Fiscal-Year 2020 Financial Results

On February 25, 2021 Theratechnologies Inc. (Theratechnologies, or Company) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported its financial results for the fourth quarter and its fiscal year ended November 30, 2020 (Fiscal 2020) (Press release, Theratechnologies, FEB 25, 2021, View Source [SID1234575677]).

"2020 marked a transformative year for Theratechnologies that included significant and swift advancements to our pipeline and growing revenues. Despite the global pandemic, we filed two investigational new drug applications for our oncology and NASH programs and recognized record sales for our HIV business. Entering 2021, this momentum has continued as we received "study-may-proceed" letters for both pipeline programs and a fast track designation for our lead peptide-drug conjugate TH1902 for treatment of all sortilin-expressing cancers. Following our accomplishments in 2020 and continued expected progress through 2021, we believe we are well-positioned to reach our key business targets and milestones," said Paul Lévesque, President and Chief Executive Officer, Theratechnologies.

Fiscal 2020 Financial Results

The financial results presented in this press release are taken from the Company’s Management’s Discussion and Analysis, or MD&A, and audited consolidated financial statements, or Audited Financial Statements, for the twelve-month period ended November 30, 2020, or Fiscal 2020, which have been prepared in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. The MD&A and the Audited Financial Statements can be found at www.sedar.com, on EDGAR at www.sec.gov and at www.theratech.com. Unless specified otherwise, all amounts in this press release are in U.S. dollars and all capitalized terms have the meaning ascribed thereto in our MD&A.

ADC Therapeutics to Participate in Cowen 41st Annual Health Care Conference

On February 25, 2021 ADC Therapeutics SA (NYSE:ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, reported that Chris Martin, Chief Executive Officer, will participate in a fireside chat at the Cowen 41st Annual Health Care Conference on Thursday, March 4, 2021, at 12:50 p.m. ET (Press release, ADC Therapeutics, FEB 25, 2021, View Source [SID1234575676]).

A live webcast of the fireside chat will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

Radius Health, Inc.: Fourth Quarter and Full Year Results

On February 25, 2021 Radius Health, Inc. ("Radius" or the "Company") (Nasdaq: RDUS), reported its financial results for the fourth quarter ended December 31, 2020 as well as full year 2020 results (Press release, Radius, FEB 25, 2021, View Source [SID1234575675]). In addition, a number of brief business updates are included.

Q4 2020 FINANCIAL AND BUSINESS HIGHLIGHTS:

Q4 2020 U.S. net sales of TYMLOS were $60 million, an 8% year-over-year increase vs. Q4 2019
TYMLOS U.S. new patient starts increased by 26% in Q4 2020 vs. Q3 2020
FY 2020 FINANCIAL AND BUSINESS HIGHLIGHTS:

FY 2020 U.S. TYMLOS net product revenue was $208 million vs. FY 2019 net product revenue of $173 million – year-over-year growth of 20%
Balance sheet: approx. $115 million of cash, cash equivalents, and marketable securities at year end
Reduced actual total company headcount by 25+% vs. full year 2020 budget
Reduced real estate footprint and infrastructure by approximately 50%
Pivoted U.S. commercial effort to focus on post-menopausal high risk fracture patients
Increased U.S. commercial productivity (net rev. per sales person) by approximately 50%
Completed elacestrant business development out-licensing transaction with the Menarini Group
Completed RAD140 business development out-licensing transaction with Ellipses Pharma Limited
Completed abaloparatide business development out-licensing transction with Paladin Labs in Canada
Completed RAD011 business development acquisition transaction for global rights
OTHER BUSINESS HIGHLIGHTS:

Abaloparatide

ATOM phase 3 study, evaluating abaloparatide for use in osteoporotic men at high risk for fracture, remains on track for 2H 2021 read-out
wearABLe phase 3 study, evaluating the effects on bone mineral density of abaloparatide delivered via a novel transdermal system, remains on track for 2H 2021 read-out
In Japan, our partner Teijin continues to make progress within the Japan regulatory and market processes
Our partner in Canada – Paladin Labs – is advancing with plans to progress the abaloparatide molecule through the regulatory process
In the EU, we continue to advance meetings and dialogue regarding a possible re-submission of abaloparatide
RAD011

A dedicated and experienced team has been created to advance the molecule and asset
Our initial focus: Prader Willi Syndrome (PWS) for the U.S. and other global markets
Assessing additional product pathways with focus on other orphan metabolic, endocrine indications
Elacestrant

EMERALD phase 3 Study, with partner Menarini Group, remains on track for a 2H 2021 read-out
Fourth Quarter 2020 Financial Results

Three Months Ended December 31, 2020

Net Loss
For the three months ended December 31, 2020, Radius reported a net loss of $21.4 million, or $0.46 per share, compared to a net loss of $24.7 million, or $0.54 per share, for the three months ended December 31, 2019.

For the three months ended December 31, 2020, non-GAAP adjusted net income, was $10.8 million, or $0.23 per share, compared to non-GAAP adjusted net loss of $13.3 million, or $0.29 per share, for the three months ended December 31, 2019.

Revenue
For the three months ended December 31, 2020, TYMLOS net product revenues were $59.9 million compared to approximately $55.7 million for the three months ended December 31, 2019.

Costs and Expenses
For the three months ended December 31, 2020, research and development expense was $36.4 million compared to $34.5 million for the three months ended December 31, 2019, an increase of $1.9 million, or 5%. This increase was primarily driven by a $16.0 million increase in RAD011 program expenses, a $3.4 million increase in abaloparatide transdermal system program costs, which was partially offset by a $18.4 million decrease in elacestrant program costs.

Twelve Months Ended December 31, 2020

Net Loss
For the twelve months ended December 31, 2020, Radius reported a net loss of $109.2 million, or $2.35 per share, compared to a net loss of $133.0 million, or $2.89 per share, for the twelve months ended December 31, 2019.

For the twelve months ended December 31, 2020, non-GAAP adjusted net loss was $62.3 million, or $1.34 per share, compared to non-GAAP adjusted net loss of $90.9 million, or $1.98 per share, for the twelve months ended December 31, 2019.

Revenue
For the twelve months ended December 31, 2020, TYMLOS net product revenues were $208.4 million compared to approximately $173.3 million for the twelve months ended December 31, 2019.

Costs and Expenses
For the twelve months ended December 31, 2020, research and development expense was $159.7 million compared to $116.8 million for the twelve months ended December 31, 2019, an increase of $43.0 million, or 37%. This increase was primarily a result of an increase of $39.9 million in program spending for the abaloparatide transdermal system project costs and an increase of $16.0 million in other costs due to the Benuvia licensing expense. These increases were partially offset by a $11.9 million decrease in program spending for elacestrant research which is a result of $39.3 million of reimbursable expenses offsetting year to date expenses.

For the twelve months ended December 31, 2020, selling, general and administrative expenses were $144.2 million compared to $152.7 million for the twelve months ended December 31, 2019, a decrease of $8.6 million, or 6%. This decrease was primarily the result of a $6.3 million decrease in professional fees, a $4.0 million decrease compensation related expenses. These decreases were offset by a $1.7 million increase in other costs.

As of December 31, 2020, Radius had $115.3 million in cash, cash equivalents, restricted cash, and marketable securities. Based upon our cash, cash equivalents and marketable securities balance as of December 31, 2020, 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 Fourth Quarter 2020 Financial Results, Radius will host a conference call and live audio webcast at 8:30 a.m. ET today, February 25, 2021, to review the commercial, research and development, and financial highlights and provide a Company update.

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 25th at 11:30 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 8266586.