Nevro Announces Prelim Revenue

Fourth Quarter 2021 Worldwide Revenue of Approximately $102.5 Million

Full-Year 2021 Worldwide Revenue of Approximately $386.6 Million

Company Expects to Exceed High End of Previously Provided Fourth Quarter 2021 Non-GAAP Adjusted EBITDA Guidance

Company to Present Today at J.P. Morgan Healthcare Conference at 4:30 pm Eastern Time

Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced its preliminary, unaudited fourth quarter and full-year 2021 revenue results and expects to exceed the high end of its previously provided fourth quarter 2021 non-GAAP adjusted EBITDA guidance.

Fourth Quarter 2021

Preliminary, unaudited fourth quarter 2021 worldwide revenue is expected to be approximately $102.5 million, compared to $109.7 million in the fourth quarter in the prior year period and $114.4 million in the fourth quarter of 2019. Worldwide revenue for the fourth quarter 2021 includes approximately $4.0 million of revenue for painful diabetic neuropathy (PDN) indication.

Preliminary, unaudited fourth quarter 2021 U.S. revenue is expected to be approximately $88.2 million, compared to $94.6 million in the prior year period and $97.9 million in the fourth quarter of 2019. Fourth quarter U.S. trial procedures were up approximately 3% versus prior year. In addition, both trial and permanent implant rates in the U.S. steadily improved in the second half of 2021 and were approaching pre-COVID 2019 levels. Fourth quarter U.S. PDN trial procedures represented approximately 7% of total U.S. trial volume and grew approximately 92% sequentially over the previous quarter.

Preliminary, unaudited fourth quarter 2021 international revenue is expected to be approximately $14.3 million, compared to $15.1 million in the prior year period and $16.5 million in the fourth quarter of 2019.

Although the company is not providing preliminary, unaudited fourth quarter 2021 non-GAAP adjusted EBITDA results at this time, the company expects to exceed the high end of its previously provided fourth quarter 2021 non-GAAP adjusted EBITDA guidance range of approximately negative $10 million to negative $13 million.

Nevro to Present Today at J.P. Morgan Healthcare Conference

D. Keith Grossman, Chairman, CEO and President of Nevro, will present at the J.P. Morgan Healthcare Conference today at 4:30 pm Eastern Time. A live webcast of this virtual event, as well as an archived recording, will be available in the Investors section of Nevro's website at www.nevro.com.

Nevro's J.P. Morgan Healthcare investor presentation is available in the Investors section of Nevro's website at www.nevro.com on the "Events and Presentations" page.

https://finance.yahoo.com/news/nevro-announces-preliminary-unaudited-fourth-110000300.html

FDA: Revive May Proceed with Pivotal Phase 3 Trial for Schizophrenia Therapy

  Brilaroxazine is a novel serotonin and dopamine receptor modulator currently being developed for diseases with dysfunctional serotonin signaling including neuropsychiatric and pulmonary indications -

- Initiation of both Phase 3 trials is expected by end of January 2022 -

https://finance.yahoo.com/news/reviva-pharmaceuticals-holdings-inc-receives-110000744.html

RxSight Prelim Financial and Operational Results

 RxSight, Inc., an ophthalmic medical device company dedicated to improving the vision of patients following cataract surgery, today announced preliminary unaudited financial and operational results for the fourth quarter and fiscal year 2021.

Preliminary Unaudited Results

• Preliminary unaudited fourth quarter 2021 revenue is expected to be approximately $8.4 million, representing growth of approximately 71% compared to the prior year period, driven by:

  • Sale of 45 Light Delivery Devices (LDD™s), expanding the installed base to 206 LDDs as of December 31, 2021; and

  • Sale of 2,959 Light Adjustable Lenses (LAL®s).

• Preliminary unaudited 2021 fiscal year revenue is expected to be approximately $22.6 million, representing growth of approximately 54% compared to the prior year, driven by:

  • Sale of 114 LDDs; and

  • Sale of 8,328 LALs.

• Preliminary unaudited cash, cash equivalents and short-term investments as of December 31, 2021, is expected to be approximately $159.3 million.
  

“Our fourth quarter financial results demonstrate continued adoption by innovative cataract surgeons and further acceptance by patients of the RxSight® value proposition for customized vision after cataract surgery,” said Ron Kurtz, CEO and President of RxSight. “With increasing awareness and availability of our LAL technology, the completed roll-out of ActivShield™, and our growing commercial team, we believe we are well positioned to drive continued growth in 2022.”

The Company’s fourth quarter and full year 2021 financial results are preliminary and are subject to the completion of the Company’s 2021 audit. Audited fourth quarter and full year 2021 financial results will be announced in early March.

https://finance.yahoo.com/news/rxsight-inc-announces-preliminary-unaudited-210000885.html

Apria Stock Rockets Higher on Acquisition by Owens & Minor

 Shares of Apria, a healthcare equipment provider, rose sharply on the announcement that it was being bought by healthcare tech company Owens & Minor for a $1.45 billion equity value.

https://www.barrons.com/articles/apria-stock-acquisition-owens-minor-51641820023

Bome Biologics jumps after presentation

 The stock price of Bone Biologics Corp (NASDAQ: BBLG) – a developer of orthobiologic products for spine fusion markets – increased by over 30% pre-market today. Investors are responding positively to Bone Biologics announcing that Jeffrey Frelick, the company’s president and chief executive officer, will present at the H.C. Wainwright BioConnect Virtual Conference being held January 10 – 13, 2022. 

A pre-recorded presentation is going to be available starting Monday, January 10 at 7:00 a.m. Eastern time. And interested parties may access a webcast of the presentation on the investor relations section of the company’s website.

https://pulse2.com/bone-biologics-stock-nasdaq-bblg-why-the-price-jumped-today/

Dexcom: Prelim Q4 Revenue, Summary Data from G7 U.S. Pivotal Trial

 -DexCom, Inc. (Nasdaq: DXCM), the leader in real-time continuous glucose monitoring ("CGM"), today reported that it expects preliminary, unaudited revenue for the fourth quarter ended December 31, 2021 to be approximately $698 million, an increase of 23% over the fourth quarter of 2020. U.S. revenue is expected to be approximately $517 million, representing growth of 15% over the fourth quarter of 2020. International revenue is expected to be approximately $181 million, an increase of 54% over the fourth quarter of 2020. International growth was approximately 41% on an organic1 basis.

For fiscal 2021, total preliminary, unaudited revenue is expected to be approximately $2.448 billion, an increase of more than 27% over 2020 on a reported basis and 26%1 on an organic basis.

"Dexcom once again demonstrated the ability to execute on its strategic initiatives and significantly expand its global customer base in 2021, delivering organic revenue that exceeded the midpoint of our original guidance by more than $160 million," said Kevin Sayer, Dexcom’s Chairman, President and CEO. "I am incredibly proud of the Dexcom team, whose resilience to bring Dexcom CGM technology to people with diabetes throughout the world remains steadfast. As we enter 2022, we are well-positioned for another exciting year ahead, highlighted by the launch of our innovative G7 CGM System."

Dexcom G7 U.S. Pivotal Trial Data

Dexcom will present data on its next generation interoperable CGM, drawn from the company’s U.S. pivotal trial2, during its presentation at the 40th annual J.P. Morgan Healthcare conference this morning at 10:30 A.M. Eastern Time. These data highlight the industry-leading precision of the G7 CGM System that accompanies several feature enhancements designed to deliver an enhanced customer experience. Summary mean absolute relative difference (MARD) from the pivotal trial was as follows:

- Adults: 8.2%

- Pediatrics: 8.1%

2022 Outlook

For 2022, Dexcom currently anticipates total revenue of approximately $2.82 billion to $2.94 billion, representing expected growth of approximately 15% to 20% over 2021. This growth outlook considers sensor volume growth driven by increasing CGM awareness for people with Type 1 and Type 2 diabetes, continued international expansion, shifting channel mix and overall market dynamics.

Dexcom will provide further details related to its 2022 financial expectations on the fourth quarter earnings call.

Fourth Quarter 2021 Financial Results Conference Call

Dexcom will report its audited full fourth quarter and fiscal 2021 financial results on Thursday, February 10, 2022 after the close of market. Management is currently scheduled to host a conference call at 4:30 p.m. (Eastern Time) that day. More details will be provided later.

https://finance.yahoo.com/news/dexcom-reports-preliminary-unaudited-revenue-124500259.html

CVRx Reports Preliminary Fourth Quarter and Fiscal Year 2021 Financial Results

CVRx, Inc. (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced certain preliminary unaudited fourth quarter and full year 2021 revenue results, and provided a 2022 business outlook.

Fourth Quarter 2021

Total revenue for the fourth quarter of 2021 is expected to be in the range of approximately $3.6 million to $3.7 million, representing an increase of approximately 71% to 77% over fourth quarter 2020 revenue of $2.1 million. Total revenue generated in the fourth quarter of 2021 is expected to be made up of approximately $2.7 million in U.S. heart failure revenue, $0.8 million in European revenue and $0.16 million in U.S. legacy revenue.

Full Year 2021

Total revenue for full year 2021 is expected to be in the range of approximately $13.0 million to $13.1 million, representing an increase of approximately 113% to 116% over full year 2020 revenue of $6.1 million. Total revenue generated in full year 2021 is expected to be made up of approximately $8.4 million in U.S. heart failure revenue, $3.9 million in European revenue and $0.7 million in U.S. legacy revenue.

As of December 31, 2021, the Company had a total of 46 active implanting centers, as compared to 38 as of September 30, 2021. The number of sales territories in the U.S. increased by three to a total of fourteen during the three months ended December 31, 2021.

As of December 31, 2021, cash and cash equivalents were $142 million. Net cash used in operating and investing activities was $29 million for the twelve months ended December 31, 2021.

“We are very proud of our accomplishments during 2021 considering the material pandemic headwinds that our entire global organization faced. We more than doubled our revenue as a result of the launch of Barostim for heart failure in the U.S. and the expansion of our commercial organization, and we progressed our product innovation roadmap that includes product enhancements as well as our new ultrasound-guided implant toolkit,” said Nadim Yared, President and Chief Executive Officer of CVRx. “While our fourth quarter results were below our expectations due to material challenges in our international business as a result of widespread lockdowns in Europe , we continued to see resilience in our U.S. heart failure business.”

“We are highly confident in our ability to continue to grow the business in the future despite the overhang of COVID-19 that persists into 2022. We will execute on our commercial strategy with the continued expansion of our salesforce and the efforts to grow the utilization of Barostim,” continued Mr. Yared. “We are very excited about the position we are in to take advantage of the large opportunity that exists to accelerate the adoption of Barostim and bring relief to as many patients suffering with cardiovascular illness as possible.”

Business Outlook

For the full year of 2022, the Company expects:

• Total revenue between $20.0 million and $23.0 million;

• Gross margin between 74.0% and 76.0%;

• Operating expenses between $55.0 million and $61.0 million

For the first quarter of 2022, the Company expects to report total revenue between $3.6 million and $4.0 million.

Upcoming Investor Conference Presentation

The Company will be participating in the 40th Annual J.P. Morgan Healthcare Conference, including a company presentation on Tuesday, January 11, 2022 at 3:45 pm Eastern Time. Webcasts of the presentation and panel discussion will be available online at the investor relations page of the Company’s website at ir.cvrx.com/news-events/events.

https://finance.yahoo.com/news/cvrx-reports-preliminary-fourth-quarter-130000192.html