On November 5, 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 third quarter ended September 30, 2020 (Press release, Nevro, NOV 5, 2020, View Source [SID1234570225]).

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Third Quarter 2020 Financial Overview
Worldwide revenue for the third quarter of 2020 was $108.5 million, an increase of 8% compared to $100.2 million in the prior year period. On a sequential basis, third quarter worldwide revenue increased 92% compared to the second quarter of 2020. U.S. revenue in the third quarter of 2020 was $90.9 million, an increase of 8% compared to $84.2 million in the prior year period. On a sequential basis, third quarter U.S. revenue increased 78% compared to the second quarter of 2020. In the third quarter of 2020, total U.S. permanent implants increased 9%, while trials were down 5% compared to the prior year period. U.S. revenue growth in the third quarter of 2020 was driven by an increase in patient and customer activity compared to the severely COVID-impacted second quarter of 2020. Daily patient trial activity increased 50% over the second quarter of 2020 and improved sequentially every month from July to October. The Company estimates a majority of the canceled permanent implant cases from the second quarter of 2020 were completed by the end of the third quarter of 2020. International revenue was $17.5 million, an increase of 10% on an as reported basis (5% on a constant currency basis), compared to $15.9 million in the prior year period. On a sequential basis, third quarter International revenue increased 226% compared to the second quarter of 2020 International revenue in the third quarter of 2020 was primarily driven by a successful Omnia launch, an increase in patient and customer activity, and a rebound in customer inventory levels compared to the second quarter of 2020.

"We are pleased by the rebound in sales after a difficult second quarter and continue to be encouraged by the month-over-month improvement in trial procedures," said D. Keith Grossman, Chairman, CEO and President of Nevro. "With trials recovering, we believe our earlier expectations for roughly flat revenues compared to the prior year is still reasonable. However, increases in COVID activity around the world and any further pressure on facility capacity and patient willingness to seek care could provide some downward pressure to that view."

Gross profit for the third quarter of 2020 was $76.1 million, an increase of 9% compared to $69.9 million in the prior year period. Gross margin was 70.1% in the third quarter compared to 69.8% in the prior year period. Compared to the prior year period, the increase in gross margin in the third quarter of 2020 was primarily attributable to product mix.

Operating expenses for the third quarter of 2020 were $79.6 million, a 7% decrease compared to $85.9 million in the prior year period. The year-over-year decrease in operating expenses was primarily related to reduced travel and training-related expenses, decreases in discretionary expenses during the COVID-19 pandemic, as well as continued management focus on driving leverage throughout the business which had begun well before COVID. This was partially offset by a one-time charge of $2.5 million in the quarter related to the Company’s CFO transition. Legal expenses associated with patent litigation were $2.3 million for the third quarter of 2020, compared to $1.9 million in the prior year period.

Net loss from operations for the third quarter of 2020 was $3.5 million, a 78% improvement compared to a loss of $16.0 million in the prior year period. Adjusted EBITDA for the third quarter of 2020 was $13.6 million, compared to a loss of $2.0 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 the financial table below for GAAP to Non-GAAP reconciliations.

Cash, cash equivalents and short-term investments totaled $572.9 million as of September 30, 2020, an increase of $10.5 million in the third quarter of 2020.

PDN and NSRBP Clinical Update
Nevro’s Painful Diabetic Neuropathy (PDN) study continues to move forward and remains on track to present the next round of complete six-month data, along with a preview of 12-month responder rate data, at NANS in January of 2021. The Company has been in early discussions with the FDA regarding the submission strategy and is now planning to submit its PMA Supplement to the FDA in the fourth quarter of 2020. The Company remains on track for a second half 2021 commercial launch.

The Company also expects to present its Non-Surgical Refractory Back Pain (NSRBP) study with three-month data at NANS 2021 in January, with journal publications thereafter. In total, Nevro is expected to have a very large presence with several data presentations at the conference, including PDN and NSRBP.

Webcast and Conference Call Information
Management will host a conference call today at 1:30 pm PT/ 4:30 pm ET. Investors interested in listening to the call may do so by dialing (866) 324-3683 in the U.S. or +1 (509) 844-0959 internationally, using Conference ID: 6693376. In addition, a live webcast, as well as an archived recording, will be available on the "Investors" section of the Company’s website at: www.nevro.com.

On November 5, 2020 Luminex Corporation (Nasdaq: LMNX) reported results for its third quarter ended September 30, 2020 (Press release, Luminex, NOV 5, 2020, View Source [SID1234570224]).

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All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").

CURRENT FINANCIAL HIGHLIGHTS

Total revenue for the third quarter of $106.1M, a 35% increase over Q3 2019, driven primarily by growth associated with the current COVID-19 global pandemic
Strong profitability in Q3 with 60% gross margins, an improvement of 7 percentage points over Q3 2019
Operating margin of $11.5M or 11% of revenue, a 300% improvement over Q3 2019
Net income of $1.8M, representing 2% of revenue, and $0.04 per share, up 134% over Q3 2019
Received two BARDA awards — $5,389,813 to support a future 510(k) filing for an updated NxTAG Respiratory Pathogen Panel that includes SARS-CoV-2, and $683,500 to support future enhancement of Luminex’s COVID-19 Multiplex Antibody Test
CEO COMMENTARY

"I’m very pleased with the performance of our diversified business during these very challenging times. Our team continues to execute on our key role in addressing the demands of this pandemic. With strong revenue growth, improved gross margins and continued control over operating expenses, we are seeing healthy profitability and cash flow," said Nachum "Homi" Shamir, Chairman, President and CEO of Luminex. "As a result of these unusual times; we thought it would be helpful to share with our investors some of our preliminary estimates of our 2021 revenue guidance. Currently, we estimate that in 2021, we will generate at least $475M of revenue with accelerated improvement in profitability and cash flow. We believe that this growth will be primarily attributable to our ARIES manufacturing expansion, as well as a number of additional new products in development, including those supporting our COVID-19-related efforts and the other pipeline products in our diverse portfolio. We plan to provide more precision regarding our expectations in early 2021. However, based on our current estimates, we anticipate surpassing our $500 million annual revenue target much sooner than we previously expected, while continuing to build an outstanding company."

ADDITIONAL HIGHLIGHTS OF THE QUARTER

Molecular Diagnostics revenue for the quarter of $59.9M, up 98% over Q3 2019
Licensed Technologies Group revenue of $34.7M, down 10% from Q3 2019
Flow Cytometry revenue of $9.9M, up 13% over Q3 2019, but with continued impact from the slowdown in academic research due to COVID-19
Operating cash flow of $14.9M and $39.0M for the three and nine months ended September 30, 2020
Ended the quarter with a total order book of more than $36M, of which $9M was COVID-19 related
Sold or contracted 87 sample-to-answer systems in the quarter, the majority of which were ARIES
Received FDA EUA for the xMAP SARS-CoV-2 Multi-Antigen IgG Assay on July 16, 2020

REVENUE GUIDANCE

As of the date hereof, Luminex is providing revenue guidance as follows:

Luminex expects revenue for the full year 2020 to be approximately $410M, with growth of 23% over 2019.
Luminex expects 2021 revenue to be at or above $475 million, reflecting more than 15% growth from Luminex’s full year 2020 guidance, with such revenue growth driven primarily by significant expansion of ARIES assay sales resulting from completion of the manufacturing line expansion and new product launches.
CONFERENCE CALL

Management will host a conference call at 4:00 p.m. Central Time / 5:00 p.m. EDT, Thursday, November 5, 2020 to discuss operating highlights and financial results for the third quarter 2020. The conference call will be webcast live and may be accessed at Luminex Corporation’s website at investor.luminexcorp.com. Analysts may participate on the conference call by dialing (877) 930-7053 (U.S.) or (253) 336-7290 (outside the U.S.). The access code is 4669812. The webcast will be archived for six months on our website using the ‘replay’ link.

On November 5, 2020 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, reported its third quarter 2020 financial results (Press release, AcelRx Pharmaceuticals, NOV 5, 2020, View Source [SID1234570222]).

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"The third quarter represented one of our most active and successful quarters since DSUVIA’s approval," said Vince Angotti, Chief Executive Officer of AcelRx. "We’ve made significant progress on our revenue growth strategy, highlighted by our oral and dental surgery collaboration with Zimmer Biomet, the addition of DSUVIA to the Department of Defense Joint Deployment Formulary and our new U.S. Army contract. With the recent publication of data supporting DSUVIA’s strong value proposition, we have gained momentum in DSUVIA’s use within existing hospital and ambulatory surgery center customers, and the rate of scheduled formulary reviews. Progress within the Department of Defense continues and we expect the initial ordering of DSUVIA for deployed troops in the fourth quarter."

Third Quarter Highlights

In July, AcelRx entered into a distribution agreement with Zimmer Biomet to market DSUVIA within the dental and oral surgery markets in the United States exclusively through Zimmer Biomet’s Dental division, expanding U.S. availability of DSUVIA. It is estimated that the applicable market in dental surgeries is over 7 million annual procedures.
In July, AcelRx completed a $10 million common stock offering priced at the market with two leading life science investors.
In August, AcelRx announced the publication of a study entitled "Reduced Opioid Use and Reduced Time in the Postanesthesia Care Unit Following Preoperative Administration of Sublingual Sufentanil in an Ambulatory Surgery Setting," by Christian Tvetenstrand, MD and Michael Wolff, MD, in the Journal of Clinical Anesthesia and Pain Management. Highlights of the publication included a greater than 50% overall reduction in opioids administered perioperatively and a 34% reduction in PACU time in the DSUVIA-treated patients compared to historical controls.
In August, AcelRx announced an investigator-initiated study with Cleveland Clinic that will assess the effects of DSUVIA on post-operative recovery from orthopedic surgery.
In September, AcelRx announced that the U.S. military’s access to DSUVIA had been expanded with the addition of DSUVIA to the Department of Defense Joint Deployment Formulary (JDF).
In September, the U.S. Army awarded AcelRx with an initial contract of up to $3.6 million over four years for the purchase of DSUVIA to support a DoD study to aid the development of clinical practice guidelines.
Financial Information

Cash, cash equivalents and short-term investments balance was $43.0 million as of September 30, 2020.
Net revenues for the third quarter 2020 were $1.4 million, of which approximately $1.3 million relates to product sales (compared to $0.3 million in product sales for the second quarter of 2020).
Combined R&D and SG&A expenses for the third quarter of 2020 totaled $8.6 million, a significant reduction compared to $12.0 million for the third quarter of 2019. Excluding stock-based compensation expense, these amounts were $7.5 million for the third quarter of 2020 compared to $10.7 million for the third quarter of 2019. The decrease in combined R&D and SG&A expenses in the third quarter of 2020 was primarily due to a reduction of $1.8 million in personnel costs and a $1.1 million reduction in DSUVIA-related commercialization expenses.
Net loss for the third quarter of 2020 was $8.9 million, or $0.10 per basic and diluted share, compared to $12.7 million, or $0.16 per basic and diluted share, for the third quarter of 2019.
Webcast and Conference Call Information
As previously announced, AcelRx will host a live webcast Thursday, November 5, 2020 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss these financial results and provide other corporate updates. The webcast is accessible by visiting the Investors page of AcelRx’s website at www.acelrx.com and clicking on the webcast link. The webcast will be accompanied by a slide presentation. Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of AcelRx’s website at www.acelrx.com.

About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA, known as DZUVEO in Europe, approved by the FDA in November 2018, is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Commission approved DZUVEO for marketing in Europe in June 2018 and AcelRx is currently in discussions with potential European marketing partners.

On November 5, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported financial results for the third quarter ended September 30, 2020 and provided an update on recent business progress (Press release, Natera, NOV 5, 2020, View Source [SID1234570221]).

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Recent Accomplishments & Highlights

Processed approximately 262,000 tests in the third quarter of 2020 compared to approximately 200,200 tests processed in the third quarter of 2019, an increase of 31%.
Generated total revenues of $98.1 million in the third quarter of 2020 compared to $77.9 million in the third quarter of 2019, an increase of 26%. Generated product revenues of $93.3 million in the third quarter of 2020 compared to $66.9 million in the third quarter of 2019, an increase of 39.5%.
Practice Bulletin published by American College of Obstetrics and Gynecology (ACOG) and Society of Maternal Fetal Medicine (SMFM) supporting use of Non-Invasive Prenatal Testing (NIPT) for all pregnancies.
Received positive final coverage decision from Medicare for Signatera in colorectal cancer and commenced full commercial launch.
Received draft local coverage determination from Medicare for Signatera in immunotherapy monitoring.
Presented new Signatera data at the 2020 European Society for Medical Oncology.
Announced two prospective phase 2 trials to evaluate early stage breast cancer patients with leading pharmaceutical companies.
Successfully completed $287.5 million follow-on equity offering.
"Q3 was an exceptional quarter," said Steve Chapman, Natera’s Chief Executive Officer. "We delivered a significant increase in volumes over an already strong second quarter. We are pleased with the initial positive reaction to the ACOG/SMFM Practice Bulletin, and continue to execute nicely on our oncology and organ health commercialization plans. After years of hard work, we’re now seeing the new businesses contribute to our strong revenue growth. We are very excited about our current trajectory and are significantly raising our 2020 revenue guidance."

Third Quarter Ended September 30, 2020 Financial Results

Total revenues were $98.1 million in the third quarter of 2020 compared to $77.9 million for the third quarter of 2019. The increase in total revenues was driven primarily by a 39.5% increase in product revenues compared to the third quarter of 2019. Natera processed 262,000 tests in the third quarter of 2020, including approximately 249,300 tests accessioned in its laboratory, compared to 200,200 tests processed in the third quarter of 2019 including approximately 187,200 tests accessioned in its laboratory.

In the three months ended September 30, 2020, Natera recognized revenue on approximately 238,600 tests for which results were reported to customers in the period (tests reported), including approximately 226,700 tests accessioned in its laboratory, compared to approximately 189,600 tests reported, including approximately 178,000 tests accessioned in its laboratory, in the third quarter of 2019.

Gross profit* for the three months ended September 30, 2020 and 2019 was $46.3 million and $34.0 million, respectively, representing approximately 47% and 44% gross margin*, respectively. The company was able to achieve higher margins in the third quarter of 2020 primarily due to improved cost of goods sold per test and increased revenues.

Total operating expenses, representing research and development expenses and selling, general and administrative expenses, for the third quarter of 2020 were $102.1 million, compared to $69.5 million in the same period of the prior year. The increases were primarily driven by headcount growth to support new product offerings.

Loss from operations for the third quarter of 2020 was $55.8 million compared to $21.1 million for the same period of the prior year, which included a gain from the sale of the Evercord cord blood banking business of approximately $14.4 million.

Net loss for the third quarter of 2020 was $58.3 million, or ($0.72) per diluted share, compared to net loss of $23.1 million, or ($0.33) per diluted share, for the same period in 2019. Weighted average shares outstanding were approximately 80.9 million in the third quarter of 2020.

At September 30, 2020, Natera held $809.7 million in cash, cash equivalents, short-term investments and restricted cash, compared to $441.0 million as of December 31, 2019. As of September 30, 2020, Natera had a total outstanding debt balance of $250.0 million, comprised of $50.1 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 110 bps and a net carrying amount of $200.0 million under its seven-year convertible senior notes. The convertible senior notes were issued in April 2020 for net proceeds of $278.9 million, of which a portion was used to repay the $79.2 million obligations under the company’s 2017 term loan with OrbiMed Advisors. The gross principal balance outstanding for the convertible senior notes was $287.5 million as of September 30, 2020.

Financial Outlook

Natera anticipates 2020 total revenue of $380 million to $390 million; 2020 cost of revenues to be approximately 51% to 54% of revenues; selling, general and administrative costs to be approximately $270 million to $280 million; research and development costs to be $90 million to $95 million, and net cash burn to be $140 million to $150 million**.

* Gross profit is calculated as GAAP total revenues less GAAP cost of revenues. Gross margin is calculated as gross profit divided by GAAP total revenues.

** Cash burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2020 to be between $132 million and $142 million) and GAAP net purchases of property and equipment (estimated for 2020 to be approximately $8 million).

On November 5, 2020 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the third quarter ended September 30, 2020 (Press release, ViewRay, NOV 5, 2020, View Source [SID1234570220]).

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Third Quarter 2020 Highlights:

Total revenue of $10.1 million, primarily from one revenue unit, compared to $20.9 million, primarily from three revenue units, in the third quarter of 2019.
Received four new orders for MRIdian systems totaling $23.4 million, compared to eight new orders totaling $34.9 million in the third quarter of 2019.
Total backlog was $238.9 million as of September 30, 2020, compared to $230.7 million as of September 30, 2019.
Cash and cash equivalents were $163.9 million as of September 30, 2020.
Effective October 30, 2020, the Company amended its term loan with Silicon Valley Bank, deferring amortization until November 2022. Included in the amendment was an expansion of the facility from $56 million to $58 million, the extension of maturity from December 2023 to November 2025, and other improvements to the interest rate and select covenants.
"We are pleased with our third quarter results in light of the economic backdrop," said Scott Drake, President and CEO. "MRIdian’s clinical, strategic, and economic value propositions are resonating with customers. We received four orders in Q3, including an order from the Veterans Administration, which was a first for ViewRay. We look forward to partnering with the VA to provide the benefits of MRIdian to our nation’s heroes. In addition, we continue to demonstrate fiscal discipline on operating expenses and working capital, and reported the amendment of our term loan which extends maturity and defers amortization payments until late 2022."

Three Months Ended September 30, 2020 Financial Results:

Total revenue for the three months ended September 30, 2020 was $10.1 million compared to $20.9 million for the same period last year.

Total cost of revenue for the three months ended September 30, 2020 was $11.2 million compared to $20.3 million for the same period last year.

Total gross profit (loss) for the three months ended September 30, 2020 was $(1.1) million, compared to $0.6 million for the same period last year.

Total operating expenses for the three months ended September 30, 2020 were $23.9 million, compared to $32.3 million for the same period last year.

Net loss for the three months ended September 30, 2020 was $28.1 million, or $0.19 per share, compared to $20.8 million, or $0.21 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $163.9 million at September 30, 2020.

Nine Months Ended September 30, 2020 Financial Results:

Total revenue for the nine months ended September 30, 2020 was $38.6 million compared to $71.3 million for the same period last year.

Total cost of revenue for the nine months ended September 30, 2020 was $42.8 million compared to $72.9 million for the same period last year.

Total gross profit (loss) for the nine months ended September 30, 2020 was $(4.2) million compared to $(1.5) million for the same period last year.

Total operating expenses for the nine months ended September 30, 2020 were $76.4 million, compared to $86.9 million for the same period last year.

Net loss for the nine months ended September 30, 2020 was $81.8 million, or $0.55 per share, compared to $85.0 million, or $0.87 per share, for the same period last year.

Conference Call and Webcast

The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The conference ID number is 9819479. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until November 12, 2020. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 9819479.