On April 23, 2020 Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, reported financial results for the quarter ended March 31, 2020 (Press release, Edwards Lifesciences, APR 23, 2020, View Source [SID1234556558]).

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First Quarter Results and Outlook

Sales grew nearly 14% to $1.1 billion
TAVR sales grew 24%; underlying1 sales grew 25%
EPS was $1.47; adjusted1 EPS grew 14% to $1.51
Sales were significantly impacted by the effects of COVID-19 the last few weeks of Q1
2020 sales and EPS guidance substantially reduced as a result of COVID-19
"I want to recognize the extraordinary actions that our 14,000 employees around the world have taken to overcome the unique challenges associated with COVID-19," said Michael A. Mussallem, chairman and CEO. "On behalf of everyone at Edwards, I want to express our deep gratitude to our clinician partners and the global healthcare community for their tireless dedication to serving patients during this challenging time. We appreciate their strong leadership and brave commitment to patient care, and we are dedicated to supporting them as they address this global health crisis."

First Quarter 2020 Results

Sales for the quarter ended March 31, 2020 were $1.1 billion, up 14% over the prior year on both a reported and underlying basis. Diluted earnings per share for the quarter were $1.47, while adjusted earnings per share grew 14%, to $1.51.

Transcatheter Aortic Valve Replacement (TAVR)

For the quarter, the company reported global TAVR sales of $742 million, an increase of approximately 24% over the first quarter last year, or 25% on an underlying basis. Global TAVR sales growth through early March was consistent with the company’s fourth quarter global growth rate. This was dramatically impacted in the last few weeks of the quarter as procedures decreased as a result of COVID-19 disruptions. Globally, average selling prices were stable.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

First quarter TMTT sales were $10 million. From a commercial standpoint, the company experienced strong momentum with accelerated adoption of the PASCAL mitral valve system in Europe. TMTT sales were tracking to expectations until the last few weeks of the quarter, when sales declined abruptly due to the impact of COVID-19.

Edwards remains focused on transforming care for patients with mitral and tricuspid valvular disease by developing a portfolio of innovative therapies supported by a growing body of clinical evidence. The company continues to gain experience and make meaningful progress across its portfolio and investors can expect to hear informative updates regarding the PASCAL system, Cardioband and EVOQUE tricuspid replacement valve system at the upcoming EuroPCR medical meeting.

Surgical Structural Heart and Critical Care

Surgical Structural Heart sales for the quarter were $193 million, down 10% compared to the first quarter of 2019, and down 9% on an underlying basis. As expected, driven by the rapid adoption of TAVR, the U.S. surgical aortic valve procedure headwinds experienced in the fourth quarter persisted into the first quarter. This was partially offset by the continued adoption of the company’s premium INSPIRIS surgical aortic valve. During the last few weeks of March, there was a sharp deceleration in procedures related to COVID-19.

Critical Care sales were $183 million for the quarter, representing an increase of 4% versus the first quarter of 2019, or 1% on an underlying basis. This performance was lifted by strong demand for the company’s disposable pressure monitoring devices used in intensive care units as a result of the COVID-19 pandemic.

Additional Financial Results

For the quarter, the company’s adjusted gross margin was 76.7%, consistent with the prior year quarter. This year’s rate benefitted from a favorable product mix, offset by lower FX hedge gains and spending in support of the new European Medical Device regulations.

Selling, general and administrative expenses increased 10% to $308 million for the quarter, driven by additions that Edwards has made in field clinical personnel to support TAVR cases in the U.S. and TMTT in Europe.

Research and development for the first quarter increased 9% to $187 million, or 16.6% of sales. This increase was primarily the result of continued investments in the company’s transcatheter mitral and tricuspid therapies.

Free cash flow for the first quarter was $125 million, defined as cash flow from operating activities of $207 million, less capital spending of $82 million.

Cash, cash equivalents and short-term investments totaled $1.0 billion at March 31, 2020. Total debt was $595 million. The company purchased 3 million shares for $615 million during the first quarter.

Outlook

As it is difficult to accurately predict the progression of COVID-19 and the extent of the disruption to hospital procedures utilizing the Edwards therapies, there is a wide range of potential outcomes for sales and earnings for 2020. The company assumes the impact of COVID-19 on sales will be most severe in the second quarter, followed by a gradual recovery in the third quarter, and a fourth quarter that better resembles its original expectations for sales.

Overall, 2020 sales guidance for Edwards is now expected to be $4.0 to $4.5 billion versus the company’s previous range of $4.6 to $5.0 billion. Additionally, the company now expects full year 2020 adjusted earnings per share of $4.75 to $5.25 versus previous guidance of $6.15 to $6.40. For the second quarter of 2020, the company projects total sales to be between $700 and $900 million.

"This is a very difficult time for structural heart patients as they weigh the risk of COVID-19 versus the severe effects of progressive heart valve disease. We will continue to actively engage with healthcare providers as they confront extraordinary disruptions in 2020. There are still many patients in need and we remain confident in our long-term patient-focused strategy and innovation pipeline," said Mussallem.

On April 23, 2020 Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) reported that it will host a webcast and conference call to discuss the Company’s financial results for the quarter ended March 31, 2020, and provide a general business overview, on Monday, May 11, 2020, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, APR 23, 2020, View Source [SID1234556557]).

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Conference Call Details
The live conference call on Monday, May 11, 2020, at 4:30 p.m. ET, 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 9579507. 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.

On April 23, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (nsqNSCLC) (Press release, Innovent Biologics, APR 23, 2020, View Source [SID1234556556]). Tyvyt was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and has been the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL) since November 2019.

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The NDA was based on the pre-specified interim analysis of a randomized, double-blind, Phase 3 clinical trial (ORIENT-11)—Tyvyt (sintilimab injection) or placebo in combination with ALIMTA and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement. Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt in combination with ALIMTA and platinum demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with ALIMTA and platinum, which met the pre-defined efficacy criteria. After a median follow up of 8.9 months, the median PFS of the experimental group and the control group assessed by Independent Radiographic Review Committee was 8.9 months and 5.0 months respectively, HR (95%CI) = 0.482 (0.362,0.643), P < 0.00001. The safety profile is consistent with previously reported sintilimab studies, and no new safety signals were identified. Detailed data will be released in an upcoming international academic conference and journal.

Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of ORIENT-11 study, stated: "Nearly half of Chinese nsqNSCLC patients lack sensitizing EGFR mutation or ALK rearrangement, which makes them do not respond to targeted therapy. ORIENT-11 study has demonstrated a significant delay of disease progression brought by sintilimab in combination with chemotherapy in this patient population."

Dr. Hui ZHOU, Vice President of Medical Science and Strategy Oncology of Innovent, stated: "The morbidity and mortality of lung cancer both rank first among all types of cancers in China. Despite treatment advances, there remains significant unmet needs for additional effective treatment options for lung cancer patients. The acceptance of NDA by the NMPA represents an important progress in demonstrating the potential value of Tyvyt in lung cancer. We will actively cooperate with the regulatory authority to bring the high quality therapy to more patients with advanced non-squamous NSCLC as soon as possible."

"The intention of Lilly’s strategic cooperation with Innovent is to bring new anti-tumor treatments, developed with global standards, to patients in China. As the success of this partnership, Tyvyt is the only anti-PD-1 monoclonal antibody included in the NRDL for relapsed or refractory classical Hodgkin’s lymphoma," said Dr. Li WANG, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "With the encouraging result of ORIENT-11, Tyvyt may soon expand its indication to lung cancer. In the future, we will strengthen cooperation with Innovent to further explore Tyvyt’s potential in the field of immuno-oncology therapy and how Tyvyt may bring benefits to more patients."

About ORIENT-11 Trial

ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial to evaluate the efficacy and safety of Tyvyt (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum as first-line therapy for advanced or recurrent nsqNSCLC without sensitizing EGFR mutation or ALK rearrangement (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.

A total of 397 subjects have been enrolled in ORIENT-11 trial and randomized in a 2:1 ratio to receive either sintilimab 200mg or placebo in combination with ALIMTA (pemetrexed) and platinum every 3 weeks for up to 4 cycles, followed by either sintilimab or placebo plus ALIMTA maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About nsqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, rendering the patients with no chance of radical resection. Meanwhile, even after radical surgery patients still have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China are non-squamous subtype and 50 percent of nsqNSCLC are without sensitizing EGFR mutation or ALK rearrangement. These patients do not respond well to targeted therapy and there are limited treatment options available to them.

About Tyvyt (Sintilimab Injection)

Tyvyt (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after at least two lines of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. Tyvyt is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for sintilimab injection to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

On April 23, 2020 GlaxoSmithKline plc (LSE/NYSE:GSK) reported data from an updated analysis of the GARNET trial, which demonstrated that dostarlimab, an investigational anti-programmed death-1 (PD-1) monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient (dMMR) endometrial cancer who progressed on or after a platinum-based regimen (Press release, GlaxoSmithKline, APR 23, 2020, View Source [SID1234556555]).

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This updated analysis included patients with dMMR endometrial cancer who had measurable disease at baseline and ≥6 months of follow-up by the data cutoff (n=71). Patients received 500 mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression. The primary endpoints were confirmed objective response rate (ORR) and duration of response (DOR), as assessed against RECIST v 1.1 by blinded independent central review. GARNET is the largest dataset evaluating an anti-PD-1 in endometrial cancer.

Treatment with dostarlimab showed an ORR of 42% (95% CI; 31-55) and a disease control rate of 58% (95% CI; 45-69). Overall, 13% of patients had a complete response and 30% of patients had a partial response. At the time of data cutoff, with a median follow up of 11.2 months, the median DOR had not been reached (1.87+ to 19.61+ months).

Dr. Axel Hoos, Senior Vice President and Head Oncology R&D, GSK said: "We are committed to developing medicines for patients who face high unmet medical need. We believe in the clinical potential of dostarlimab for women with advanced or recurrent dMMR endometrial cancer who urgently need additional treatment options for this incurable disease."

Dr. Ana Oaknin, Head of the Gynaecologic Cancer Program at Vall d’Hebron Institute of Oncology, Barcelona, and primary investigator for GARNET said: "There are limited treatment options for women with advanced or recurrent endometrial cancer, and prognosis of these patients is poor. The results observed in the GARNET trial indicate the potential of dostarlimab to offer a new treatment option for women with this challenging disease."

The safety population included all patients with dMMR endometrial cancer who received at least one dose of dostarlimab (n=104). Results showed that dostarlimab was well tolerated with a low discontinuation rate (2%) due to treatment-related adverse events (TRAEs), consistent with the safety profiles of other anti-PD-1 therapies. The most commonly reported TRAEs were asthenia (15%), diarrhea (15%), fatigue (14%), and nausea (13%). No deaths associated with dostarlimab were reported in the study.

Dostarlimab is not currently approved for use anywhere in the world.

About GARNET
The ongoing phase I GARNET trial is evaluating dostarlimab as monotherapy in patients with advanced solid tumors. Part 2B of the study includes five expansion cohorts: dMMR/microsatellite instability-high (MSI-H) endometrial cancer (cohort A1), mismatch repair-proficient endometrial cancer (cohort A2), non-small cell lung cancer (cohort E), dMMR/MSI-H non-endometrial cancer (cohort F), and platinum-resistant ovarian cancer without BRCA mutations (cohort G). GARNET is still enrolling patients.i,ii

About Dostarlimab
Dostarlimab is an investigational humanized anti-PD-1 monoclonal antibody that binds with high affinity to the PD-1 receptor and blocks its interaction with the ligands PD-L1 and PD-L2.iii

In addition to GARNET, dostarlimab is being investigated for women with recurrent or primary advanced endometrial cancer in combination with standard of care (chemotherapy) in the phase III RUBY trial.iv Dostarlimab is also being evaluated in combination with other therapeutic agents for patients with advanced solid tumors or metastatic cancer.

About Endometrial Cancerv
Endometrial cancer is a main type of uterine cancer that forms in the inner lining of the uterus, known as the endometrium. Endometrial cancer can be classified as mismatch repair-deficient/microsatellite instability-high or mismatch repair-proficient/microsatellite stable. There are limited treatment options for women whose disease progresses on or after first-line therapy. Endometrial cancer is the sixth most common cancer in women worldwide.vi

GSK in Oncology
GSK is focused on maximizing patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilizing modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

On April 23, 2020 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 7, 2020, following the release of its first quarter 2020 financial results (Press release, Puma Biotechnology, APR 23, 2020, View Source [SID1234556554]).

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The call may be accessed by dialing 1-866-548-4713 (domestic) or 1-323-794-2093 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.