Inspire Medical stock rises on massive Q4 EPS beat

Inspire Medical Systems (NYSE:INSP) shares ticked up today on fourth-quarter results that came in well ahead of the consensus forecast.

Shares of INSP were up more than 7% at $268.22 apiece in morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose more than 13%.

The Minneapolis-based implantable sleep apnea treatment developer posted profits of $3.2 million in the quarter. That amounts to earnings of 10¢ per share on sales of $137.9 million for the three months ended Dec. 31, 2022. Both earnings and sales topped Wall Street estimates. Analysts projected losses per share of 57¢ and revenues reaching $129.3 million.

Inspire recorded a massive bottom-line gain from losses of $2.4 million this time a year ago. It achieved that thanks to a 75% bump in revenues. The company has achieved significant sales growth over the past year, perhaps due in part to the absence of Phi…

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Axonics, Outset lead medtech space on Deloitte’s list of fastest growing companies

Deloitte today released its “North America Technology Fast 500” list of growing companies, including a handful of medtech firms.

The list, which ranking of the fastest-growing North American companies across a range of sectors, included several “Life Sciences” outfits. Immunology company Vir Biotechnology led the way in first place on the list.

Axonics (Nasdaq:AXNX) represented the highest-ranked medical device company at No. 4. According to Deloitte, the company registered 25,401% growth over a three-year period. Axonics reported $180.3 million in revenue in fiscal 2021, compared to $707,000 in fiscal 2018.

The company topped last year’s version of the list. Axonics develops novel products for adults with bladder and bowel dysfunction. Its sacral neuromodulation (SNM) systems provide adults suffering from overactive bladder and/or fecal incontinence with long-lived, easy-to-use, safe, clinically effective therapy. The compa…

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Inspire Medical Systems raises guidance on 77% sales growth in Q3

Inspire Medical Systems (NYSE:INSP) today posted third-quarter results that beat the overall consensus on Wall Street and raised its full-year guidance.

The Minneapolis-based sleep apnea treatment device company reported losses of $16.8 million, or -60¢ per share, on sales of $109.2 million for the three months ended Sept. 30, for a sales growth of 77.01% compared with Q3 2021.

Earnings per share were 16¢ ahead of The Street, where analysts were looking for sales of $94.61 million.

“Once again, the Inspire team executed extremely well during the third quarter, continuing the strong momentum we saw in the first half of 2022,” President and CEO Tim Herbert said in a news release. “Despite the macroeconomic challenges that persisted through the quarter, the team remained focused on delivering high-quality patient outcomes. Our growth was driven primarily by the increased utilization at existing sites, along with the addition of 59 new impl…

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10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

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Inspire Medical Systems appoints former Zimmer Biomet exec as VP of investor relations

Inspire Medical Systems (NYSE: INSP) today announced it appointed Ezgi Yagci as VP of investor relations, effective immediately.

Yagci joins the company from Zimmer Biomet, where she was the investor relations manager since July 2020. She was responsible for all aspects of earnings preparation, investment conference participation, sell-side interactions and targeted, proactive shareholder outreach and engagement. Yagci was also responsible for Zimmer Biomet’s environment, social and governance disclosure to enhance the company’s annual sustainability report.

“The team is very excited to welcome Ezgi and her vast experience in the medical technology sector to Inspire,” President and CEO Tim Herbert said in a news release. “She will have a positive impact on our expanding investor relations program and play a key role in contributing to the overall strategy of the organization.”

Yagci has more than 15 years of experience as an institution…

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Inspire Medical Systems revenue up 71% in Q2

Inspire Medical Systems (NYSE: INSP) easily blew past Wall Street predictions in Q2, though the company is scaling back its gross margin projections.

Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable, pacemaker-like device that uses neurostimulation to treat obstructive sleep apnea. It lost $14.5 million, or 53¢ per share, off $91.4 million in sales for the quarter ended June 30, 2022 — versus a loss of $13.1 million, or 48¢ per share, off $53 million in sales for the same quarter a year before.

The results handily beat the expectations of Wall Street analysts, who had expected a loss of 62¢ per share off $78.28 million in revenue.

“The Inspire team executed extremely well during the second quarter, continuing the rebound from the first quarter that was challenged by both COVID and our normal seasonality. Moreover, our strong second quarter performance overcame several challenges common across the medical technolog…

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Inspire Medical appoints new independent board directors

Inspire Medical Systems (NYSE:INSP) announced today that it appointed Cynthia Burks and Dr. Charisse Sparks as board directors.

The appointment of Burks and Sparks as independent directors to the board of the minimally invasive sleep apnea treatment developer was made effective on July 28, 2022.

Burks previously served as chief human resources officer for Genentech of the Roche Group, leading the company’s efforts to attract, develop and retain employees. Inspire said in a news release that her skills include expertise in human capital strategy, including talent management, culture, diversity, equity, inclusion and organizational design.

She also serves as an observer on the board of the WD-40 Company and a director on the board of directors of Torch. She has roles on the boards of Juma Ventures and Summer Search, both non-profit organizations.

Currently, Sparks is the chief medical officer at AppliedVR, leading the company̵…

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FDA approves expanded, full-body MRI compatibility with Inspire therapy

Inspire Medical Systems recently announced that FDA has approved additional MRI scan conditions for use with Inspire therapy

Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. Company officials in a July 6 news release said the full-body MRI approval expands the Inspire use labeling.

The labeling previously allowed only head, neck and extremity MRI scans.

“Expanding compatible use to include full-body MRI is a significant milestone in our effort to bring Inspire to more obstructive sleep apnea patients who struggle with CPAP. Providing the full range of scan options enables us to better help all current and future patients with their imaging needs,” said Tim Herbert, president and CEO of Inspire. “Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy. Compatibility with this important diagnostic tool…

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Inspire Medical Systems invests in EnsoData and Ognomy

Sleep apnea treatment developer Inspire Medical Systems has invested in two private companies with digital health tech that could better screen people for sleep problems.

Minneapolis-based Inspire Medical is the maker of a minimally-invasive, implantable device that uses neurostimulation to treat obstructive sleep apnea. It made a $10 million minority equity investment in Madison, Wisconsin–based EnsoData, creator of an FDA-approved sleep study analysis platform called EnsoSleep. The EnsoSleep platform integrates with a sleep labs’ existing software and diagnostic devices, using AI to automatically analyze and score sleep studies.

Inspire Medical also provided seed funding to Buffalo, New York–based Ognomy, creator of the Ognamy app that sleep physicians built to shift sleep apnea diagnosis and treatment from the clinic to people’s homes.

Tim Herbert, CEO of Inspire Medical Systems, said the tools created by EnsoData and Ognomy could help clinician…

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Inspire Medical Systems beats The Street in Q4, expects strong 2022 sales despite COVID-19 impact

Inspire Medical Systems (NYSE: INSP) shares ticked up today on fourth-quarter results that topped the consensus forecast.

The Minneapolis-based sleep apnea treatment developer posted losses of $2.4 million, or 9¢ per share, on sales of $78.4 million for the three months ended Dec. 31, 2021, for a bottom-line gain closer to breakeven on sales growth of 70.4%.

Inspire Medical’s losses per share of 9¢ came in well ahead of Wall Street projections of 44¢. The company’s revenues also topped analysts’ projections, coming in 0.3% ahead of expectations.

“We experienced significant momentum throughout our business in the fourth quarter,” Inspire Medical Systems President and CEO Tim Herbert said in a news release. “The 70% year-over-year revenue growth achieved in the fourth quarter reflects accelerated patient demand for Inspire therapy and our increasing capacity at new and existing centers. In addition, our ability to improve patient access t…

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These medtech companies care a lot about research

[Image from Unsplash] They’re making glaucoma-treating stents, tumor-treating fields, coin-sized CGMs and more. Discover the medtech companies that spend the most on research as a percentage of revenue.

The list comes from our annual Big 100 report, which examines the world’s 100 largest medical device companies and ranks them by revenue. (Check out our full Big 100 report here.) 

Medtech companies that have spent the most on R&D as a percentage of revenue have had much to boast about:

Glaukos’s iStent inject is an eye implant designed for cataract surgery to reduce intraocular pressure in adults with mild-to-moderate primary open-angle glaucoma. It was a Prix Galien USA Awards nominee last year. Novocure announced in September 2021 that the FDA had granted breakthrough designation for its NovoTTF-200T liver cancer treatment system. NovoTTF-200T system is a tumor treating fields (TTFields) delivery system for use in tandem with atezolizumab and be…
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Inspire Medical Systems says reimbursement questions cleared up at CMS

Inspire Medical Systems (NYSE: INSP) says CMS has answered some questions about how it will reimburse its implantable sleep apnea treatment device.

The Golden Valley, Minnesota–based company announced on November 10 that CMS has published updated addendum files for the 2022 ambulatory surgery center payment system.

The update included an assigned device offset percentage and final payment rate for new CPT code 64582 — already approved by the AMA CPT Editorial Panel for closed-loop hypoglossal nerve stimulation.

The updated files reflect the national average ASC reimbursement rate for CPT code 64582 of $24,828.64 — versus an initial proposal to peg it at roughly $17,000. The new rate goes into effect on January 1, 2022.

SVB Leerink Research analysts previously noted on November 2 that a CMS final rule published after market close still showed a roughly $17,000 reimbursement range, though Inspire Medical Systems management pointed out CMS commentary…

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