Ongoing glucose control and insulin pump manufacturers continued their success in the last quarter of 2021, while other Meditexes were forced to control the third quarter results by a pandemic.
Dexcom, Tandem Diabetes Care and Insulet have increased users and revenue or sales in between. Continuous jump Using wearables and digital health services. Success in sugar technology is still in its infancy, with Dexcom’s G7 CGM system and the Insulin Omnipod 5 insulin pump.
Dexcom CEO Kevin Sayer told investors that the G7 system is still validated in Europe for 2021 CE and is preparing the company for the fourth quarter. The CEO added that the company is expected to submit a 510 (k) application to the FDA with the G7 hardware and software for both Android and iPhone systems in the next few weeks.
“The G7 is on schedule, and it’s coming,” Sayer said during an October 28 revenue call. “All of the G7-related efforts are moving at a rapid pace in this area.”
JP Morgan analysts wrote that the system’s FDA application will be presented as an integrated CGM 510 (k), meaning that the product will be “reviewed in accordance with the 90-day decision policy, which indicates that the US could be launched by the end of 1 Q / beginning 2Q” by 2022.
Investors seemed impressed by Dexcom’s results and the G7 update, posting nearly 9% of the shares between October 28 and Wednesday.
Insulet CEO Shasi Petrovich told investors that the company is still working with the FDA on an upcoming review. Omnipod 5 pump. Petrovic Insulet said it was now in the final stages of reviewing the agency’s request for more information in September.
Omnipod 5 communicates with CGM and provides insulin levels to patients immediately, depending on blood sugar levels. The product directly opposes tandem control IQ technology and Mediterranean mini-automatic pump systems.
Analysts have described the latest Omnipod product as a market leader because it will be a wireless plug-in, comes at a low cost and is available to patients at the pharmacy, not a permanent medical device channel.
Insulet initially expected Omnipod 5 to launch in the first half of 2021 and Petrovic. He said in May That the company was in the final stages of the process. However, the background of the epidemic and the priority given to CV-19 work have slowed the review, and the agency has asked for more information.
Due to the expected approval after the fourth quarter, Omnipod 5 will have some releases this year before it expands in 2022. Although the limited start is expected to last longer.
“Omnipod 5 will be in a limited market release for some time,” CFO Wayde McMillan said during a November 4 revenue call. “In 2022 we will get some benefit from Omnipod 5… but we will not see a full year impact from Omnipod 5 to 2023 and above.”
William Blair Analyst They agreed that the 2023 sales contribution would be greater than any other contribution in 2022, but that the product could eventually lead to the adoption of a general insulin pump.
“Finally, we believe that Omnipod 5 will significantly accelerate the market growth of insulin pumps. The product will be one of the biggest users and participants in the coming years,” the analysts wrote.
As new products turn patients into wearable and digital healthcare, companies are hitting local and Wall Street expectations and hitting the spotlight.
Meanwhile, Medtech’s giant Abbott Laboratories is one of the major beneficiaries of the development of sugar technology. Chief Executive Robert Ford told investors on October 20 that the company’s Freelance Libre CGM products had nearly $ 1 billion in sales and had nearly 200,000 new subscribers in the past quarter.
Abbott’s new CGM Freestyle Libre 3 is currently out in Europe, but the company has not yet announced when it will launch in the United States.
Diabetes technology companies have achieved 2021 successes in Q3.
|Revenue / Sales (M)||The growth of YOY|
|Tandam Diabetes Care||$ 179.6||45%|
Source: Companies’ latest revenue reports
Global markets are still critical
Both Tandem and Dexcom have seen their share of operations outside the United States increase.
Tandam’s global cargo increased by 209% year on year and sales by 189% to $ 46.5 million. By comparison, domestic imports increased by 10% year-on-year and sales rose by about 24% to about $ 133 million, with health facilities slightly frustrated by the closure of regular operations due to Delta differences.
One of the world’s leading vendors is the company’s IQ technology, which combines CGM and pumps to create an automated insulin supply system. Control IQ was recently released in France and Germany, and CEO John Sheridan told investors that the product was growing in new markets.
“The initial demand was very strong, and we think we have a long way to go,” Sheridan said during a November 3 revenue call. “I can say that the joy we have seen here in America is being repeated. [outside the U.S.]”
Global expansion is a key priority for the company to move forward. According to the Sheriff, Tandem plans to expand to 15 new territories in the near future, bringing the company to 95 to 110 states.
Dexcom has also seen stronger growth outside the United States than at home. Global sales grew by $ 160.6 million in the first quarter, up 57% year-on-year and more than 20% year-over-year. US revenue grew by 23 percent annually to about $ 490 million.
Insulet has also seen global growth – overseas Omnipood revenue increased by 17 percent to $ 93.1 million – but executives have repeatedly warned that the company’s revenue will increase competition for the automatic insulin delivery system.
In an email, SVB Lincoln analyst Daniel Antalfi said the increased competition was mainly due to the tandem IQ and Basal IC technology and the Mediterranean 780G mini-pump system.
After the release of Insulet Automatic Insulin Delivery System, “our sense of global competitive dynamics should be reversed and continue,” especially in the case of low inflation in the double-digit region. They wrote in a report.
Insulet Petrovic was aware of the challenges ahead, but he was a force to be reckoned with. After moving to seven new countries in the last 12 months, the CEO said Insulet plans to expand to specific geographical areas and increase global production capacity.
“Our immediate focus is to increase our global engagement across the Middle East and Europe, and in the medium term, we plan to expand further in the Asia Pacific region,” Petrovic said.