Novocure Reports Second Quarter 2019 Financial Results and Provides Company Update

On July 25, 2019 Novocure (NASDAQ: NVCR) reported financial results for the three and six months ended June 30, 2019, highlighting a track record of execution, strengthening financial performance and an advancing clinical pipeline (Press release, NovoCure, JUL 25, 2019, View Source [SID1234537757]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields.

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Novocure reports second quarter 2019 financial results and provides company update

An "active patient" is a patient who is on Optune 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.

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

"The second quarter was transformative for Novocure. We achieved our first ever quarter of positive operating income driven by record quarterly net revenues of $86.7 million with more than 2,700 patients on Optune at quarter end," said Asaf Danziger, Novocure’s CEO. "Our torso device, NovoTTF-100L, was approved by the FDA to treat malignant pleural mesothelioma in combination with standard chemotherapies via the Humanitarian Device Exemption pathway. For the first time in over 15 years, there’s a new FDA-approved treatment for mesothelioma."

"Our momentum continues into the third quarter. Last week, Medicare released a final local coverage determination and fee schedule amount which provides coverage and pricing of Optune for newly diagnosed GBM, effective September 1, 2019. In response to public comments, the final coverage criteria eliminated or revised many of the restrictions originally proposed," stated Bill Doyle, Novocure’s Executive Chairman. "Our focus is unwavering on disciplined execution intended to deliver both sustainable near-term growth from existing indications and significant long-term shareholder value from our pipeline."

Second quarter 2019 operating statistics and financial update

There were 2,726 active patients on Optune at June 30, 2019, representing 26 percent growth versus June 30, 2018, and four percent growth versus March 31, 2019. The increase in active patients was driven primarily by prescription growth in the United States and Japan and the ongoing benefit from continued growth in prescriptions for patients with newly diagnosed GBM globally.

In the United States, there were 1,846 active patients on Optune at June 30, 2019, representing 17 percent growth versus June 30, 2018.
In Germany and other EMEA markets, there were 737 active patients on Optune at June 30, 2019, representing 32 percent growth versus June 30, 2018.
In Japan, there were 143 active patients on Optune at June 30, 2019, representing 286 percent growth versus June 30, 2018.
Additionally, 1,362 prescriptions were received in the three months ended June 30, 2019, representing nine percent growth compared to the same period in 2018, and four percent growth compared to the three months ended March 31, 2019.

In the United States, 989 prescriptions were received in the three months ended June 30, 2019, representing four percent growth to the same period in 2018.
In Germany and other EMEA markets, 299 prescriptions were received in the three months ended June 30, 2019, representing 13 percent growth compared to the same period in 2018.
In Japan, 74 prescriptions were received in the three months ended June 30, 2019, representing 131 percent growth compared to the same period in 2018.
For the three months ended June 30, 2019, net revenues were $86.7 million, representing 41 percent growth versus the same period in 2018. Revenue growth was primarily driven by an increase of 557 active patients in our currently active markets, representing 26 percent growth, and an increase in net revenues per active patient. The increase in net revenues per active patient was primarily driven by improved reimbursement rates, which we believe are sustainable. The improved reimbursement rates also resulted in an additional benefit of approximately $5 million to second quarter net revenues that we do not expect to be as significant in future quarters.

Cost of revenues was $21.1 million compared to $19.8 million for the same period in 2018, representing an increase of 6 percent. The increase in cost of revenues was primarily due to the cost of shipping transducer arrays to a higher volume of active patients partially offset by a reduction in the cost of goods per active patient driven by ongoing efficiency initiatives and scale. Gross margin was 76% compared to 68% for the same period in 2018.

Research, development and clinical trials expenses were $19.5 million compared to $11.4 million for the same period in 2018, representing an increase of 71 percent. This was primarily due to an increase in clinical trial and personnel expenses for our phase 3 pivotal trials and an increase in costs associated with medical affairs, regulatory and engineering.

Sales and marketing expenses were $23.7 million compared to $19.2 million for the same period in 2018, representing an increase of 24 percent. This was primarily due to increased marketing expenses related to the launch of NovoTTF-100L for malignant pleural mesothelioma and increased personnel costs.

General and administrative expenses were $21.2 million compared to $18.2 million for the same period in 2018, representing an increase of 17 percent. This was primarily due to an increase in personnel costs and an increase in professional services.

Net loss was $1.3 million, or $0.01 per share, compared to net loss of $15.5 million for the same period in 2018, or $0.17 per share, representing an improvement of 94 percent.

At June 30, 2019, we had $180.1 million in cash and cash equivalents and $104.5 million in short-term investments, for a total balance of $284.6 million in cash, cash equivalents and short-term investments.

Anticipated clinical and regulatory milestones

Zai Lab initiation of phase 2 pilot trial in gastric cancer (2019)
Data from phase 2 pilot HEPANOVA trial in advanced liver cancer (H2 2020)
Interim analysis of phase 3 pivotal LUNAR trial in non-small cell lung cancer (H2 2020)
Data from phase 3 pivotal METIS trial in brain metastases (2021)
Interim analysis of phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2021)
Final data from phase 3 pivotal LUNAR trial in non-small cell lung cancer (2022)
Interim analysis of phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2022)
Final data from phase 3 pivotal PANOVA-3 trial in locally advanced pancreatic cancer (2022)
Final data from phase 3 pivotal INNOVATE-3 trial in recurrent ovarian cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2019 financial results today, Thursday, July 25, 2019, at 8 a.m. EDT. 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 1438824.

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.

Geron to Announce Second Quarter Financial Results on August 1, 2019

On July 25, 2019 Geron Corporation (Nasdaq: GERN) reported that it will release its second quarter 2019 financial results after the market closes on Thursday, August 1, 2019 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, JUL 25, 2019, View Source [SID1234537756]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

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Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 2379646. Participants are advised to dial in at least 10 minutes prior to minimize any delay in joining the call. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

Genomic Health to Announce Second Quarter 2019 Financial Results and Host Conference Call on Thursday, August 1, 2019

On July 25, 2019 Genomic Health, Inc. (NASDAQ: GHDX) reported that the company will host a conference call and webcast on Thursday, August 1 at 4:30 p.m. Eastern Time to discuss its second quarter 2019 financial results (Press release, Genomic Health, JUL 25, 2019, View Source [SID1234537755]). The call and webcast will follow the release of the second quarter financial results after market close.

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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

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Conference Call Details
To access the live conference call on August 1 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada, or +1 (224) 357-2389 internationally. The conference call ID is 7667797. Please dial in approximately 10 minutes prior to the start of the call.

To access the live and subsequently archived webcast of the presentation, go to the Investor Relations section of the company’s web site at View Source Please connect to the web site at least 15 minutes prior to the presentation to allow for any software download that may be necessary.

Akebia Therapeutics to Report Second Quarter 2019 Financial Results

On July 25, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease, reported plans to release its financial results for the second quarter ended June 30, 2019, on Thursday, August 8, 2019 before the opening of the financial markets (Press release, Akebia, JUL 25, 2019, View Source [SID1234537754]).

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Akebia will host a conference call at 9:00 a.m. Eastern Time on Thursday, August 8th to discuss its second quarter financial results and recent business updates. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 7274126. The call will also be webcast LIVE and can be accessed via the Investors section of the Company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through August 14, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 7274126. An online archive of the conference call can be accessed via the Investors section of the Company’s website at View Source

Vertex Announces Dr. Jeffrey Leiden to Transition to Role of Executive Chairman, Effective April 1, 2020 and Dr. Reshma Kewalramani Appointed as New Chief Executive Officer

On July 25, 2019 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that its Board of Directors has approved the planned transition of Chairman, President and Chief Executive Officer Jeffrey Leiden, M.D., Ph.D, into the role of Executive Chairman of the Board, effective April 1, 2020 (Press release, Vertex Pharmaceuticals, JUL 25, 2019, View Source [SID1234537753]). At that time, Vertex’s Chief Medical Officer Reshma Kewalramani, M.D., will become President and Chief Executive Officer and will be appointed to serve on the company’s Board of Directors.

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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

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"Jeff’s leadership has transformed Vertex and delivered extraordinary value for patients and shareholders through the discovery, development and commercialization of multiple transformative medicines. Vertex has never been stronger and is well-positioned for the future with a clear and differentiated research and business strategy, an exceptionally strong financial position, a deep leadership team, and an inclusive culture of innovation," said Bruce I. Sachs, Lead Independent Director of Vertex’s Board. "The Board of Directors is immensely grateful to Jeff for his strategic vision and relentless dedication to science and serial innovation, which has both transformed the treatment of cystic fibrosis and produced a pipeline of breakthrough medicines for other serious diseases. The Board looks forward to Jeff’s ongoing leadership and strategic guidance in his role as Executive Chairman."

Sachs continued, "The Board has been working with Jeff for several years to plan for a smooth and effective leadership transition that will ensure strategic and operational continuity for Vertex. The entire Board is excited that Reshma will become Vertex’s next CEO. She is an accomplished scientist and physician with more than 20 years of experience in medicine and biotechnology, and has a deep understanding and appreciation of Vertex’s strategy, business and culture."

"It has been a tremendous privilege to lead Vertex and our outstanding senior leadership team since 2012. I look forward to playing a continued, active role in the company over the next several years, and supporting Reshma and our team through this transition," said Dr. Leiden. "Having worked closely with Reshma for the last several years, I know that she is tremendously talented, extremely passionate about our patient-centric mission, and fully prepared to lead Vertex as we enter our next phase as a company. Her background as a physician/scientist gives her a deep understanding of the core of Vertex – our outstanding science and commitment to serial innovation. She also is a strong, collaborative leader with a proven ability to execute against our strategy to deliver results. Importantly, she has a track record of putting patients first and driving innovation to have a transformative impact on patients’ lives."

Dr. Kewalramani commented, "I am honored to become Vertex’s next CEO and to continue to work alongside Jeff, the Board and our leadership team at a time of such opportunity for the company. Consistent execution of our strategy has produced a leading portfolio of products for CF that will potentially treat up to 90 percent of patients with the disease; a productive research engine that has already led to an enviable clinical stage pipeline of potentially breakthrough medicines in five additional diseases, including Alpha-1 Antitrypsin Deficiency, Pain, Sickle Cell Disease, Beta Thalassemia, and APOL1-mediated kidney diseases; and the financial strength to continue to invest in future innovation. Most importantly, we have a talented and dedicated team of people across the company that I will be incredibly proud to lead."

Dr. Kewalramani joined Vertex in February 2017 and currently serves as the company’s Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer. In this role, she oversees clinical development, medical affairs, drug safety and other related functions, and is responsible for developing, advising and driving execution of Vertex’s clinical development programs. Prior to Vertex, Dr. Kewalramani spent more than 12 years at Amgen where she held a variety of roles across Research and Development, including as Vice President, Global Clinical Development, Nephrology & Metabolic Therapeutic Area and Vice President, U.S. Medical Organization, a group she established and grew to assume responsibility for the full portfolio of molecules across six therapeutic areas.

Dr. Kewalramani completed her internship and residency in Internal Medicine at the Massachusetts General Hospital and her fellowship in Nephrology at the Massachusetts General Hospital and Brigham and Women’s Hospital combined program. She received her medical degree, with honors, from the Boston University School of Medicine. Dr. Kewalramani also completed the General Management Program at Harvard Business School and is an alumnus of the school. She is the industry representative to the FDA’s Endocrine and Metabolic Drug Advisory Committee.

Dr. Leiden has agreed to serve as Executive Chairman through the first quarter of 2023.