On November 6, 2019 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported financial results for the third quarter ended September 30, 2019 (Press release, Nevro, NOV 6, 2019, View Source [SID1234550515]).

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Senza Omnia is the first and only spinal cord stimulation (SCS) system designed to deliver Nevro’s proprietary HF10 therapy and all SCS frequencies between 2 and 10,000 Hz.
Senza Omnia is the first and only spinal cord stimulation (SCS) system designed to deliver Nevro’s proprietary HF10 therapy and all SCS frequencies between 2 and 10,000 Hz.
Revenue for the third quarter of 2019 was $100.2 million, a 5% increase compared to $95.6 million during the prior year period. U.S. revenue for the third quarter of 2019 was $84.2 million, a 6% increase compared to $79.6 million in the prior year period. The year-over-year increase in U.S. revenue was primarily driven by SCS procedure growth which was partially offset by the impact of the Company’s previously announced decision to alter its practice regarding certain high-volume product orders. International revenue was $16.0 million compared to $16.0 million in the prior year period. While flat on an as-reported basis, this represents a 5% increase on a constant currency basis.

"Our strong third quarter 2019 financial results demonstrate our continued improvement in commercial focus and execution across the organization. In the U.S., we saw an 18% year-over-year increase in both patient trial procedures and permanent implant procedures," said D. Keith Grossman, Chairman, CEO and President. "Yesterday we announced the commercial launch of our groundbreaking Senza Omnia system, the only SCS system that offers HF10 therapy in addition to all other SCS frequencies, as well as frequency pairing with HF10. We’re excited by the early customer feedback we’ve received, and we believe this new product introduction, along with our ongoing operational initiatives, positions us for continued growth in 2020 and beyond."

Gross profit for the third quarter of 2019 was $69.9 million, a 4% increase compared to $67.2 million in the prior year period. Gross margin was 69.8% in the third quarter of 2019 compared to 70.3% in the prior year period.

Operating expenses for the third quarter of 2019 were $85.9 million, a 12% increase compared to $76.5 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. Legal expenses associated with patent litigation were $1.9 million for the third quarter of 2019, compared to $3.5 million in the prior year period.

Net loss from operations for the third quarter of 2019 was $16.0 million, compared to a loss of $9.2 million in the prior year period. Adjusted EBITDA for the third quarter of 2019 was a loss of $2.0 million, compared to a positive $5.2 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 below for GAAP to Non-GAAP reconciliations.

Cash, cash equivalents and short-term investments totaled $232.8 million as of September 30, 2019. Net cash used during the third quarter of 2019 was $1.2 million and $31.8 million for the nine months ended September 30, 2019.

Full Year 2019 Financial Guidance
Following the Company’s third quarter 2019 financial results, Nevro management is increasing its financial guidance for 2019 worldwide revenue from $368-$374 million to $383-$386 million. Gross margin is expected to be in the 68-70% range as a percentage of revenue.

CFO Retirement and Transition Plan
The Company also announced that Andrew Galligan has decided to retire after nearly a decade with Nevro. Mr. Galligan will remain Chief Financial Officer (CFO) through the appointment of a successor. Mr. Galligan will serve in a transitional role for some period of time thereafter. Nevro is initiating a search to identify the Company’s next CFO.

"Andrew has played a very significant role in Nevro’s growth as he oversaw the Company’s evolution from its early days as a small private company," Grossman continued. "Since my arrival in March of 2019, Andrew has not only been an exceptional leader, but on a personal level he has been an invaluable partner to me. I want to thank Andrew for his many contributions and I look forward to continuing to benefit from his perspective in the coming months."

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: 4787437. 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.

On November 6, 2019 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2020 first quarter ended September 30, 2019 (Press release, Lannett, NOV 6, 2019, View Source [SID1234550514]).

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"Our topline and bottom-line for the fiscal 2020 first quarter exceeded our expectations, largely due to strong sales of certain key products and the launch of Posaconazole late in the period," said Tim Crew, chief executive officer of Lannett. "We continue to build our business and expand our opportunities for ongoing growth. In the current quarter, we are now launching our third new product and plan to launch several more over the next several months. In addition, we secured exclusive U.S. commercialization rights to an approved ANDA for Levothyroxine Sodium Tablets, as well as an advanced development program for generic ADVAIR DISKUS, a drug used to treat symptoms associated with asthma and other respiratory diseases. Both medications are potentially large market opportunities.

"Near the end of the first quarter, we completed an $86.25 million convertible notes offering, due 2026, and used the net proceeds to pay down half of our outstanding Term A Loans. Our existing cash position exceeds the remaining balance of the Term A Loans, which mature in about one year. As a result of the transaction, we lowered our interest expense, strengthened our balance sheet and improved our financial flexibility."

For the fiscal 2020 first quarter, on a GAAP basis, net sales were $127.3 million compared with $155.1 million for the first quarter of fiscal 2019. Gross profit was $42.7 million, or 33% of total net sales, compared with $59.1 million, or 38% of total net sales. Net loss was $12.2 million, or $0.32 per share. Net loss for the prior year first quarter, which included asset impairment charges of $369.5 million, was $287.5 million, or $7.65 per share.

For the fiscal 2020 first quarter reported on a Non-GAAP basis, net sales were $127.3 million compared with $155.1 million for the first quarter of fiscal 2019. Adjusted gross profit was $52.6 million, or 41% of adjusted net sales, compared with $68.7 million, or 44% of adjusted net sales, for the prior-year first quarter. Adjusted interest expense was $15.3 million compared with $16.9 million for the first quarter of fiscal 2019. Adjusted net income was $8.8 million, or $0.22 per diluted share, compared with $16.9 million, or $0.44 per diluted share, for the fiscal 2019 first quarter.

Guidance for Fiscal 2020
As discussed above, the company expects interest and other expense for fiscal 2020 to be lower than previously estimated as a result of the convertible notes offering. Based on its current outlook, the company revised certain items in its GAAP guidance and reiterated adjusted guidance for fiscal year 2020, except for interest and other. The full guidance is as follows:

**A reconciliation of Adjusted amounts to most directly comparable GAAP amounts can be found in the attached financial tables.

Conference Call Information and Forward-Looking Statements
Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for its fiscal 2020 first quarter ended September 30, 2019. The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49151826. The call will be broadcast via the Internet at www.lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures
This news release contains references to Non-GAAP financial measures, including Adjusted EBITDA, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). Management uses these measures internally for evaluating its operating performance. The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. The company also believes that including Adjusted EBITDA, as defined in the company’s existing Credit Agreement, is appropriate to provide additional information to investors to demonstrate the company’s ability to comply with financial debt covenants. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) restructuring expenses, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

*Adjusted EBITDA excludes the same adjustments discussed above, as well as additional adjustments permitted under the company’s existing Credit Agreement.

On November 6, 2019 Theravance Biopharma, Inc. (NASDAQ: TBPH) announced today that management will participate in a corporate presentation at the 28th Annual Credit Suisse Healthcare Conference on Tuesday, November 12, 2019, at 3:00 p.m. MT (Press release, Theravance, NOV 6, 2019, View Source [SID1234550513]). The conference will take place November 11-13 at The Phoenician in Scottsdale, Arizona.

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A live broadcast will be available by visiting the Investor Relations section of Theravance Biopharma’s website at www.theravance.com, under the Presentations & Events tab. Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software. Audio replays will be available for 30 days following the presentation.

On November 6, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported its financial results and business highlights for the third quarter of 2019 (Press release, Cellular Biomedicine Group, NOV 6, 2019, View Source [SID1234550512]).

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"During the third quarter of 2019, we made great strides in both corporate and clinical progress. We started our U.S. expansion for research and clinical development in a new 22,000 square foot facility in Rockville, Maryland in October 2019. This milestone will allow us to foster strategic partnerships, develop new innovations and support continued development of CBMG’s cell therapy-based immune-oncology assets that have shown promise in early proof-of-concept trials in China," said Tony (Bizuo) Liu, Chief Executive Officer for the Company.

"We also had continued progress on the clinical side, with the initiation of our Phase II clinical trial in China of AlloJoin therapy for knee osteoarthritis (KOA). Additionally, our autologous stem cell therapy program for KOA, ReJoin, was accepted by the NMPA in China to begin a Phase II clinical trial. We are excited about our regenerative medicine programs as we are currently the only company that has received two clinical trial acceptances for any stem cell program in China."

Mr. Liu continued, "Presentations of our pre-clinical and clinical data at upcoming medical conferences later this year will demonstrate continued focus on our immune-oncology pipeline and we are proud to provide an update of our commitment to cancer immunotherapy."

Third Quarter 2019 and Other Recent Corporate Developments

New facility to expand research and development and to support clinical development in Rockville, MD
Initiation of AlloJoin therapy for multiple-site Knee Osteoarthritis Phase II clinical trial
ReJoin therapy received stem cell drug application acceptance for Phase II clinical trial by NMPA
Upcoming Clinical and Preclinical Presentations:

Society of Immunotherapy in Cancer ("SITC") 34th Annual Meeting
Poster Presentation
The Next Generation "Off-The-Shelf" Universal CAR For Adoptive Immunotherapy (Abstract ID: P229)
Friday, November 8, 2019 – 7:00 AM – 8:00 AM ET
Gaylord National Hotel & Convention Center, National Harbor, MD
American Society of Hematology ("ASH") 61st Annual Meeting and Exposition
Oral Presentation
Developing a Novel Anti-BCMA CAR-T For Relapsed or Refractory Multiple Myeloma (Submission ID: 125372)
Saturday, December 7, 2019 – 7:45 AM – 8:00 AM ET
Orange County Convention Center (OCCC), Orlando, FL
Financial Results for the Third Quarter of 2019

Net loss allocable to common stock holders for the quarter and nine months ended September 30, 2019 was $15.9 million and $37.3 million respectively, compared to $12.7 million and $30.4 million for the same periods in 2018.
General and administrative expenses for the quarter and nine months ended September 30, 2019 were $3.3 million and $10.0 million, respectively, compared to $3.3 million and $9.6 million for the same periods in 2018.
Research and development expenses for the quarter and nine months ended September 30, 2019 were $13.1 million and $28.2 million respectively, compared $6.5 million and $18.0 million for the same periods in 2018.
Net cash used in operating activities for the nine months ended September 30, 2019 was $28.1 million, compared to $19.4 million for the same period in 2018.
Cash balance was $29.0 million as of September 30, 2019, compared to $39.7 million as of June 30, 2019.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on Wednesday, November 6th at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-855-327-6838

International: 1-604-235-2082

Webcast:

View Source

Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 10007976

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on November 20, 2019)

On November 6, 2019 4D Pharma plc (AIM: DDDD), a leading-edge pharmaceutical company in the development of live biotherapeutics, reported preliminary safety and clinical observations from an ongoing clinical phase -I / II study, in collaboration with MSD, a trade name of Merck & Co., Inc. of Kenilworth, NJUSA, in conjunction with its leading oncology candidate, Mrx0518, in combination with the MSD anti-PD-1 therapy with KEYTRUDA (pembrolizumab) in patients with advanced malignancies who previously responded and whose disease was subsequently co-administered PD-1 / PD-L1 inhibitors has progressed to evaluate (Press release, 4d Pharma, NOV 6, 2019, View Source;814041836.html [SID1234550511]). These are the first observations of an oncology study in humans with a live biotherapy product.

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Important observations:

Initial data from the first six patients show that the combination of Mrx0518 and KEYTRUDA is well tolerated.
Induction of clinically relevant response in two out of six patients with previous progressive disease
Three patients had to retire for illness-related reasons (two after the diagnosis of a progressive illness and one due to a disease-related adverse event).
The Phase I / II trial is an open-label study evaluating the safety and preliminary efficacy of Mrx0518 and KEYTRUDA in patients with renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC) and bladder cancer who have resistance against PD-1 / PD-L1 inhibitors. In preclinical studies, Mrx0518 has previously demonstrated significant efficacy as a monotherapy and as a combination therapy with the checkpoint therapy. Mrx0518 has also been shown to be an effective immune stimulant and capable of increasing the number of tumor infiltrating lymphocytes (TILs) that have been shown to be anticancer in preclinical cancer models.

Although the checkpoint therapies have proven to be effective anti-cancer treatments, they are not effective in all patients, and those who respond may develop resistance over time, leading to a loss of efficacy and progression of the disease Disease leads. The mode of action of Mrx0518 has the potential to reactivate the efficacy of checkpoint therapies, and this study was designed to investigate this effect in patients with advanced metastatic disease.

Patients eligible for the Phase I / II trial must have a progressive disease prior to enrollment, which has been confirmed by two residual scans. Part A of the study aims to enroll 12 patients, with the primary outcome being measurement of safety and tolerability. Part A will be performed over three weeks and patients will receive one cycle of KEYTRUDA, taking Mrx0518 orally twice a day (the "offer") .After completion of the first cycle, patients will be eligible for up to 35 cycles of KEYTRUDA in the drug combination (over about two years) or until disease progression occurs Patients routinely have restaging scans every nine weeks More information on the study can be found at the end of this announcement.

The clinical observations of the first six patients in Part A include:

Two patients showed partial response (according to RECIST version 1.11 criteria) with evidence of tumor disappearance and continue to participate in the study (one patient has been in the study for more than six months).
In another patient, the disease is stable and continues to participate in the study.
Two patients were excluded from the study because of a progressive disease.
One patient was excluded prior to the restaging scan for a serious disease-related adverse event.
The only patient currently tested for tumor biomarker showed signs of increased TIL after treatment (approval for biomarker assessment is optional).
No serious adverse drug reactions were noted.
Dr. Alex Stevenson, Chief Scientific Officer of 4D, said, "We are very encouraged by these early signs of activity in the combination of Mrx0518 and KEYTRUDA in patients with advanced disease. One third of patients who had previously stopped responding to PD-1 inhibitors and had a progressive disease have now shown clinical benefit. There is also a first indication in a patient suggesting that the treatment is capable of increasing the number of tumor infiltrating lymphocytes in a clinical setting, which is in line with our preclinical results. Although more work will be required to determine the robustness of the observed responses and their frequency in a larger number of patients, we are pleased to to report these initial results – the first from an oncological study with a live biotherapeutic. The open label trial continues and we will continue to review the data to optimize our future development strategy for Mrx0518 in these indications.

"These first results further support our ongoing investment in our oncology franchise. We plan to include Mrx0518 in additional clinical trials of various tumor types and settings, either in combination or as monotherapy. The next study with Mrx0518 in combination with radiotherapy for pancreatic cancer will start at MD Anderson before the end of this year. In addition, we continue to develop live biotherapeutic candidates with different modes of action for oncology applications. The first, MRx1299, is currently in GMP manufacturing development. "

Notes:
1 Criteria for assessing response to solid tumors

This notice contains inside information as defined in Article 7 of the Market Abuse Regulation (MAR) No 596/2014. The person responsible for making this announcement on behalf of the Company is Duncan Peyton . After the publication of this notice, this inside information will be considered publicly available.