On October 21, 2020 Edwards Lifesciences (NYSE: EW) reported financial results for the quarter ended September 30, 2020 (Press release, Edwards Lifesciences, OCT 21, 2020, View Source [SID1234568756]).

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Third Quarter Highlights and Outlook

Sales of $1.1 billion grew 4%; similar underlying1 growth expected in the fourth quarter
TAVR global sales grew 6%
EPS was $0.52; adjusted1 EPS grew 9% to $0.51
TMTT clinical trials now enrolling at pre-COVID levels
2020 adjusted EPS guidance increased to $1.85 to $1.95 from $1.75 to $1.95
2021 TAVR sales expected to return to double-digit growth
"I am very proud of the way our passionate team is serving patients during this difficult period. Our supply chain has delivered and our field team has continued to support the dedicated clinicians that count on Edwards," said Michael A. Mussallem, chairman and CEO. "We are pleased to report better-than-expected third quarter results despite the challenges of the ongoing COVID pandemic."

Third Quarter 2020 Results
Sales for the quarter ended September 30, 2020, were $1.1 billion, an increase of 4% over the prior year, on both a reported and underlying basis. Diluted earnings per share for the quarter were $0.52, while adjusted earnings per share grew 9% to $0.51.

Transcatheter Aortic Valve Replacement (TAVR)
For the quarter, the company reported global TAVR sales of $745 million, an increase of 6% over the third quarter last year. TAVR growth was led by continued adoption of the Edwards SAPIEN valve platform and a step-up in procedure volumes as newly diagnosed patients entered the system and were treated. The company reported therapy adoption across all geographies, with notable strength in Europe.

"Our observations indicate that most hospitals globally have determined that they can safely treat their aortic stenosis patients in need at the same time they care for COVID patients," said Mussallem.

Transcatheter Mitral and Tricuspid Therapies (TMTT)
Edwards continues to view the TMTT opportunity as one with significant unmet patient needs and the potential to drive significant growth. The company’s focus is on the advancement of three key value drivers, which it believes are the leading indicators of success: the company’s portfolio of differentiated therapies, favorable real-world clinical outcomes and results from rigorous pivotal trials which will ultimately support approvals and adoption.

Third quarter global sales were $12 million as the company resumed activation of new centers in Europe and increased commercial procedures. Edwards continues to advance commercialization of PASCAL in Europe and remains focused on physician training, procedural success and patient outcomes. The company is making progress on five TMTT pivotal studies. While initial pivotal clinical trial results could be delayed by a couple of quarters, Edwards is now enrolling patients at pre-COVID rates.

"We continue to believe the TMTT opportunity remains significant and expect a $3 billion global market by 2025," said Mussallem. "We reiterate our confidence in this long-term opportunity and are passionate about bringing a portfolio of solutions for the many patients in need."

Surgical Structural Heart and Critical Care
Surgical Structural Heart sales for the quarter were $203 million, similar to 2019 levels. During the third quarter, patients were more willing to seek heart valve surgery and hospitals more able to manage surgical patient flow. Ongoing prioritization of heart surgery in many hospitals also contributed to rebounding case volumes.

Critical Care sales were $181 million for the quarter, in-line with the year-ago period. Demand for the company’s products used in cardiac surgeries was solid but was offset by the COVID-driven impact of delayed elective procedures. Sales of Edwards’ TruWave disposable pressure monitoring devices used in the ICU were lifted by a large one-time order in Europe associated with ICU capacity expansion.

Additional Financial Results
For the quarter, the company’s adjusted gross margin was 75.5%, down from 75.9% in the prior year quarter. This decrease was driven by a negative impact from foreign currency fluctuations and incremental costs associated with responding to COVID, partially offset by improved manufacturing efficiencies.

Selling, general and administrative expenses in the third quarter were $307 million, or 26.9% of sales, compared to $306 million in the prior year. This consistent level of spending included increased transcatheter structural heart field personnel related expenses, including expanding the TMTT field organization in Europe, offset by reduced spending resulting from COVID.

Research and development expenses in the third quarter were $196 million, or 17.1% of sales, compared to $195 million in the prior year. This consistent level of spending included increased investments in transcatheter mitral valve replacement clinical trials, partially offset by lower TAVR clinical trial expenses and reduced spending resulting from COVID.

Free cash flow for the third quarter was $113 million, defined as cash flow from operating activities of $216 million, less capital spending of $103 million.

Cash and investments totaled $1.9 billion at September 30, 2020. Total debt was $595 million.

Outlook
For the fourth quarter of 2020, the company anticipates year-over-year underlying sales growth similar to the third quarter. The company is raising the bottom end of full-year 2020 adjusted earnings per share guidance to $1.85 to $1.95, versus previous guidance of $1.75 to $1.95. Looking ahead to 2021, while still early in the forecasting process, the company anticipates a return to double-digit TAVR growth and aspires to double 2020 TMTT sales.

"Edwards is a dedicated member of the critical healthcare infrastructure and I admire the agility, resourcefulness and passion of our employees in maintaining their important work on behalf of patients. Putting patients first has never been more important than it is today," said Mussallem. "I’m grateful for our extraordinary team and partners, and I am optimistic about the future of continuing to deliver innovations to patients around the world."

On October 21, 2020 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported it will release results for the third quarter 2020 on Wednesday, October 28, 2020, after the market closes (Press release, Vanda Pharmaceuticals, OCT 21, 2020, View Source [SID1234568755]).

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Vanda will host a conference call at 4:30 PM ET on Wednesday, October 28, 2020, during which management will discuss the third quarter 2020 financial results and other corporate activities. To participate in the conference call, please dial 1-866-688-9426 (domestic) or 1-409-216-0816 (international) and use passcode 8971955.

The conference call will be broadcast simultaneously and archived on Vanda’s website, www.vandapharma.com. Investors should go to the website at least 15 minutes early to register, download, and install any necessary audio software.

A replay of the call will be available on Wednesday, October 28, 2020, beginning at 7:30 PM ET and will be accessible until Wednesday, November 4, 2020, at 7:30 PM ET. The replay call-in number is 1-855-859-2056 for domestic callers and 1-404-537-3406 for international callers. The passcode number is 8971955.

On October 21, 2020 Shattuck Labs, Inc. ("Shattuck"), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, reported its presentation at the TIGIT Therapies Digital Summit 2020 being held virtually October 26 – 27, 2020 (Press release, Shattuck Labs, OCT 21, 2020, View Source [SID1234568749]).

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Presentation Details
Presentation Title: Using LIGHT to Hotwire TIGIT Blockade
Date/Time: October 26 at 10:00 a.m. EDT
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Location: www.tigit-therapies.com

The presentation will be available for download on the Events & Presentations section of the Company’s website and also will be available to registered participants of TIGIT Therapies Digital Summit 2020.

On October 21, 2020 ICON plc (NASDAQ: ICLR), a global provider of outsourced drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations, reported its financial results for the third quarter ended September 30, 2020 (Press release, ICON, OCT 21, 2020, View Source [SID1234568748]).

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CEO Dr. Steve Cutler commented, "Driven by positive market demand in conjunction with our ability to win COVID-19 related opportunities we delivered a new record $990 million of net business wins during quarter three. This represented a quarterly book to bill of 1.41 and resulted in our backlog growing to $9.4 billion, an increase of 12% year over year. Our financial position remains robust with a strong balance sheet supplemented further by solid quarterly cash collections helping to improve days sales outstanding to 45 days.

We remain well placed to face the challenges of COVID-19 and take advantage of opportunities into the future. We are therefore increasing our 2020 revenue guidance from a range of $2,650 million – $2,750 million to $2,750 million – $2,810 million and narrowing our earnings guidance from a range of $6.00 – $6.50 to a range of $6.35 – $6.50."

Third Quarter 2020 Results

Gross business wins in the third quarter were $1.2 billion and cancellations were $190 million. This resulted in net business wins of $990 million and a book to bill of 1.41.

Reported revenue for Quarter 3 was $701.7 million. This represents a year on year decrease of 1.2% or 1.9% on a constant currency basis.

Reported income from operations in the quarter was $108.4 million or 15.4% of revenue compared to $110.0 million or 15.5% of revenue for Quarter 3 2019.

Reported net income attributable to the Group for the quarter was $91.6 million or 13.1% of revenue compared with $94.8 million or 13.3% of revenue in Quarter 3 2019.

Adjusted earnings per share attributable to the Group on a diluted basis was $1.72, compared to $1.74 per share for Quarter 3 2019. GAAP earnings per share attributable to the Group on a diluted basis was $1.72, compared to $1.72 per share for Quarter 3 2019.

On a comparative basis, non-GAAP days sales outstanding were 45 days at September 30, 2020, compared with 53 days at the end of June 2020 and 56 Days at the end of September 2019.

Cash generated from operating activities for the quarter was $112.0 million and capital expenditure was $6.9 million. As a result, at September 30, 2020, the Group had net cash of $359.8 million, compared to net cash of $244.0 million at June 30, 2020 and net cash of $121.7 million at the end of September 2019.

During the quarter the company completed the successful refinance of the existing private placement of $350 million senior notes maturing on December 15, 2020. The transaction has been successfully priced over three and five year tenors at a blended rate of 2.41% compared to the current private placement blended rate of 3.37%. The drawdown of funds will coincide with the maturity of the senior notes in December 2020.

Year to date 2020 Results

Gross business wins year to date were $3.3 billion and cancellations were $520 million. This resulted in net business wins of $2.8 billion and a book to bill of 1.36.

Year to date reported revenue was $2,037 million. This represents a year on year decrease of 2.1% or 2.0% on a constant currency basis.

Reported income from operations* year to date was $289.7 million or 14.2% of revenue compared to $318.1 million or 15.3% of revenue for the equivalent prior year period.

Reported net income* attributable to the Group year to date was $246.9 million or 12.1% of revenue compared with $275.0 million or 13.2% of revenue for the equivalent prior year period.

Adjusted earnings per share* attributable to the Group on a diluted basis was $4.63, compared to $5.06 per share for the equivalent prior year period.

During the year the company recorded a charge of $18.1 million in relation to restructuring costs. US GAAP income from operations year to date amounted to $271.6 million or 13.3% of revenue. US GAAP net income attributable to the Group year to date was $231.1 million or $4.25 per diluted share, compared to $5.03 per share for the equivalent prior year period.

*before non-recurring charges.

COVID-19 Update

ICON continues to closely monitor and assess the evolving pandemic situation. The welfare and safety of ICON’s employees, customers and patients remains the Company’s highest priority. ICON is taking guidance from global health authorities, such as World Health Organisation (WHO) and Centers for Disease Control and Prevention (CDC), as well as regional health authorities and governments to ensure that ICON protects the safety and welfare of employees and abides by government directives in various jurisdictions.

COVID-19 continues to affect our global business. However, the impact has reduced in recent months as sites reopened and patient recruitment gradually improved. Where on-site monitoring is not possible we continue to use alternative approaches including remote and risk based monitoring and ‘at home’ services delivered through our Symphony Clinical Research group.

Since February, ICON has mobilised its vaccine resources to address the COVID-19 global threat, including its ability to conduct home-based trials to minimise infection. The company is currently providing clinical monitoring and safety oversight on more than 100 COVID-19 trials for both the private and government sectors.

Other Information

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this press release contains certain non-GAAP financial measures, including non-GAAP operating and net income and non-GAAP diluted earnings per share. While non-GAAP financial measures are not superior to or a substitute for the comparable GAAP measures, ICON believes certain non-GAAP information is useful to investors for historical comparison purposes.

Adjusted earnings per share attributable to the Group (Non-GAAP) has been computed by dividing non-GAAP net income attributable to the Group by the weighted average number of shares outstanding. GAAP earnings per share attributable to the Group has been computed by dividing net income attributable to the Group plus a GAAP charge associated with non-controlling interest in MeDiNova Research ("MeDiNova") by the weighted average number of shares outstanding. ICON purchased a majority shareholding in MeDiNova on May 23, 2019. ICON exercised its call on the outstanding shares in MeDiNova and derecognized the non-controlling interest effective from March 2020.

The Company entered into an agreement with a third party to jointly establish Oncacare. Oncacare will operate a specialized oncology site network in the US and EMEA regions. The Company holds a 49% interest in the voting share capital of Oncacare. The Company’s investment in Oncacare is accounted for under the equity method and records its pro rata share of the earnings/losses of this investment in Share of equity method investments in the Condensed Consolidated Statement of Operations.

ICON will hold its third quarter conference call tomorrow, October 22nd, 2020 at 9:00 EDT [14:00 Ireland & UK]. This call and linked slide presentation can be accessed live from our website at View Source A recording will also be available on the website for 90 days following the call. In addition, a calendar of company events, including upcoming conference presentations, is available on our website, under "Investors". This calendar will be updated regularly.

On October 21, 2020 Guided Therapeutics, Inc. (OTCQB: GTHP), the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, reported the successful outcome of its October 14, 2020 meeting with FDA (Press release, Guided Therapeutics, OCT 21, 2020, View Source [SID1234568746]). The purpose of the meeting was to finalize the protocol (procedure) for its new clinical study in support of its Premarketing Application for the LuViva Advanced Cervical Scan (i.e., FDA approval). The Company filed the minutes from this meeting with FDA yesterday, which the agency will review and provide any final comments on the meeting and study protocol.

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Currently, women are screened for cervical cancer using one or more laboratory-based tests that require a tissue sample. Women who test positive on these screening tests are referred to biopsy of the suspect cervical tissue. Unfortunately, because of limitations in current imaging technology, 40- 50% of the time the disease is not detected when it is actually present. In addition, the screening tests may generate up to 80% false positives. LuViva does not require a tissue sample and produces an immediate result, so that treatment can begin sooner. Previous clinical studies that included two year follow up showed that LuViva detected a significant number of these missed cases. The Company has received broad agreement from the FDA on the new study’s methodology and patient population in order to demonstrate LuViva’s ability to significantly improve the early detection of cervical cancer. The study is expected to take a few months once enrollment begins and will include approximately 300 to 600 patients.

"Reaching agreement with FDA on the intended use of LuViva and the study to support that intended use is a major milestone for us," said Gene Cartwright, CEO. "We look forward to filing the protocol with the participating clinical sites and beginning the study as soon as practicable."