Nevro Reports Fourth Quarter and Full Year 2019 Financial Results

On February 25, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported its financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Nevro, FEB 25, 2020, View Source [SID1234554759]).

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Fourth Quarter 2019
Worldwide revenue for the fourth quarter 2019 was $114.4 million, a 6% increase compared to $107.9 million in the prior year period. U.S. revenue was $97.9 million, a 7% increase compared to $91.6 million in the prior year period. Year-over-year U.S. trial growth was 17% and permanent implant growth was 20% during the fourth quarter of 2019. International revenue was $16.5 million, a 1% increase as-reported, or 3% on a constant currency basis, compared to $16.3 million in the prior year period.

"Beginning in the second quarter, we started driving quite a few changes to our commercial strategies and execution, and we quickly saw patient trials and permanent implants return to growth," said D. Keith Grossman, Chairman, CEO and President of Nevro. "More recently, we launched Senza Omnia commercially in the U.S., which allowed us to engage more constructively with our customers and offer them the only SCS platform that can provide the unique advantages of HF10 as well as the full range of SCS frequencies. Just last month, we presented encouraging three-month data from our Senza-PDN study, which was the largest SCS RCT conducted to date. I am pleased with the progress we made in 2019 and am excited by the momentum we are building in the market and the opportunity ahead of us in 2020."

Gross profit for the fourth quarter of 2019 was $81.3 million, a 7% increase compared to $76.2 million in the prior year period. Gross margin was 71.0% in the fourth quarter of 2019 compared to 70.5% in the prior year period.

Operating expenses for the fourth quarter of 2019 were $92.9 million, a 10% increase compared to $84.8 million in the prior year period. The year-over-year increase in operating expenses was primarily driven by U.S. sales and marketing personnel costs, including $2 million in structural changes in the commercial organization, and approximately $3 million in costs related to the Company’s ongoing clinical trials. Legal expenses associated with patent litigation were $1.7 million for the fourth quarter of 2019, which was consistent with the prior year period.

Net loss from operations for the fourth quarter of 2019 was $11.7 million, a 36% increase compared to a loss of $8.6 million in the prior year period. Adjusted EBITDA for the fourth quarter of 2019 was $1.5 million, a 57% decrease compared to $3.5 million in the prior year period. Adjusted EBITDA excludes certain litigation expenses, interest, taxes and non-cash items such as stock-based compensation and depreciation and amortization. Please see financial tables for GAAP to Non-GAAP reconciliations.

Cash, cash equivalents and short-term investments totaled $237.8 million as of December 31, 2019. Net cash increased during the fourth quarter of 2019 by $5.0 million and decreased by $26.7 million for the full year 2019.

Full Year 2019
Worldwide revenue for the full year 2019 was $390.3 million, a 1% increase compared to $387.3 million in the prior year period. U.S. revenue for the full year 2019 was $326.0 million, a 1% increase compared to $321.8 million in the prior year period. International revenue was $64.3 million, a 2% decrease as-reported, or a 4% increase on a constant currency basis, compared to $65.5 million in the prior year period. Please see financial statements for additional full year 2019 results and GAAP to Non-GAAP reconciliations.

2020 Financial Guidance
Nevro reiterated its full year 2020 worldwide revenue to be in the range of $435 to $440 million. In addition, the Company provided additional full year 2020 guidance as follows: Gross margin is expected to be in the range of 69% to 70% and operating expenses are expected to be approximately $355 million, including litigation expenses. To assist investors in understanding Nevro’s underlying business trends, the Company is also introducing adjusted EBITDA guidance of positive $3.0 to $10.0 million for the full year 2020, which compares to a loss of $40.3 million in 2019. Adjusted EBITDA excludes certain litigation expenses, interest, taxes and non-cash items such as stock-based compensation and depreciation and amortization. Please see financial tables for GAAP to Non-GAAP reconciliations.

Webcast and Conference Call Information
Management will host a conference call today beginning at 1:30 p.m. PT / 4:30 p.m. ET. Investors interested in listening to the conference call may do so by dialing (833) 286-5807 in the U.S. or (647) 689-4452 internationally, using Conference ID: 1864387. In addition, a live webcast will be available on the "Investors" section of the Company’s website at www.nevro.com, as well as an archived recording.

IO Biotech Announces Positive Outcome of Interim Analysis of Phase 2 Randomized Trial in First Line Non-small Cell Lung Cancer

On February 25, 2020 IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune modulating anti-cancer therapies based on its proprietary T-win technology, reported the successful outcome of a scheduled interim analysis of the ongoing Phase 2 trial (IO102-012/KEYNOTE-764) of its lead cancer therapeutic vaccine, IO102, in non-small cell lung cancer (NSCLC) (Press release, IO Biotech, FEB 25, 2020, View Source [SID1234554683]). In this randomized trial, IO102 is being tested in combination with Merck’s anti-PD1 therapy, Keytruda (pembrolizumab) as a first-line therapy in patients with metastatic non-small cell lung cancer. The interim analysis was designed as a futility analysis. The Safety Monitoring Committee has recommended to continue the trial without modifications as the futility boundary was successfully passed.

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"We set a very high hurdle for the futility boundary for the interim analysis in this difficult to treat disease. Specifically, the successful outcome of this interim analysis required the objective response rate in the experimental arm to exceed the futility boundary which was substantially higher than the historical experience with Keytruda monotherapy in this population. We are excited to note that this hurdle has been successfully crossed," said Eva Ehrnrooth, MD, PhD, chief medical officer of IO Biotech. "Through this trial, we expect to get a comprehensive data set that paves the way for a potential pivotal trial of IO102 addressing the unmet medical need in NSCLC and solid tumors."

"The year 2020 will be a transformational year for IO Biotech. We are pleased by the data generated thus far in the ongoing trial of our off-the-shelf subcutaneous injectable treatment for patients with lung cancer. Additionally, the exciting data being generated in the ongoing melanoma trial with our proprietary T-win cocktail that includes IO102 and IO103 (our two clinical lead programs based on targeting IDO and PD-L1) will allow the company to initiate pivotal trials in two indications with two drugs," said Mai-Britt Zocca, PhD, CEO and Founder of IO Biotech. "We continue to demonstrate long term durability of drug effect with a very attractive safety profile for each of our clinical stage candidates, whether alone or in any combination."

IO Biotech’s lead candidate, IO102, is an Indoleamine 2,3-dioxygenase (IDO) derived immune modulating therapy with a dual mode of action – killing both cancer cells and immune-suppressive cells. IO Biotech’s IDO-derived immune modulating therapies previously demonstrated both a favorable safety profile and promising anti-tumor activity in its first human clinical trial of heavily pre-treated patients with NSCLC.

About the Study
IO102-012/KEYNOTE-764 is an Open-label, Randomized, Phase 1/2 Trial Investigating the Safety and Efficacy of IO102 in Combination with Pembrolizumab, with or without Chemotherapy, as first-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer. This global clinical trial is planned to accrue 108 patients across around 20 sites in the U.S. and Europe.

The IO102-012/KN-764 trial is part of a collaborative agreement with Merck & Co., Inc., Kenilworth, NJ, USA (known as MSD outside the US and Canada). The clinical trial is sponsored by IO Biotech. The rights to the study results will be shared, and IO Biotech has retained global commercial rights to IO102.

About NSCLC
According to the American Cancer Society (ACS), lung cancer is the leading cause of cancer death. Each year, more people die of lung cancer than colon, breast and prostate cancers combined. The two main types of lung cancer are non-small cell lung cancer and small cell lung cancer. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. According to the ACS, the five-year survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be six percent.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About T-win Technology Platform
IO Biotech’s proprietary T-win technology platform enables identification of compounds with dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses. The company’s compounds are administered as "off-the-shelf" subcutaneous injections, distinguishing these treatments from many immuno-oncology therapies.

Syndax to Announce Fourth Quarter and Year-end 2019 Financial Results and Host Conference Call and Webcast on March 3, 2020

On February 25, 2020 WALTHAM, Mass., Feb. 25, 2020 /PRNewswire/ — Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its fourth quarter and year-end 2019 financial results on Tuesday, March 3, after the close of the U.S. financial markets (Press release, Syndax, FEB 25, 2020, View Source [SID1234554705]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Tuesday, March 3, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 2786075
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

Heron Therapeutics to Present at the 40th Annual Cowen Healthcare Conference

On February 25, 2020 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the 40th Annual Cowen Healthcare Conference on Monday, March 2nd, 2020 at 12:00 p.m. ET at the Boston Marriott Copley Place hotel (Press release, Heron Therapeutics, FEB 25, 2020, View Source [SID1234554727]).

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A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

Myovant Sciences to Present at Upcoming March Investor Conferences

On February 25, 2020 Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, reported that Lynn Seely, M.D., Myovant’s CEO, will present at the following investor conferences (Press release, Myovant Sciences, FEB 25, 2020, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-present-upcoming-march-investor-conferences [SID1234554743]):

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Cowen 40th Annual Health Care Conference in Boston, Massachusetts on Wednesday, March 4, 2020 at 9:20 a.m. Eastern time.

Barclays Global Healthcare Conferencein Miami, Florida on Wednesday, March 11, 2020 at 10:15 a.m. Eastern time.
A live webcast of the presentations will be accessible on the Events page under the Investors & Media section of the Myovant website at www.myovant.com. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay of the webcast will be available at the same location for 30 days following the conference.