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One of Orange County’s fastest-growing public companies only went public two months ago.
Beta Bionics Inc.’s concept of an artificial pancreas that regulates blood sugar levels in people with type 1 diabetes (T1D) was well received by Wall Street. It raised an upsized $234.6 million during its January debut, $120 million more than planned.
On its first day, shares rose as much as 44% to $24.50 and a $1 billion valuation (Nasdaq: BBNX).
The Irvine-based company felt the timing was right to go public, according to Chief Executive Sean Saint.
“The stars aligned for us, so we took the opportunity,” Saint told the Business Journal in a March 26 interview.
Over the last two years, sales soared more than 36,000% to $65.1 million in 2024. It generated $179,000 in 2022 from a collaboration agreement with Novo Nordisk AS.
“To be fair, we’re starting from a low base and admittedly, it’s easier to grow when you’re starting from a low base,” Saint acknowledged. “However, we’re offering something fundamentally differentiated from what was previously available.”
The performance topped the Business Journal’s annual list of fastest-growing public companies under $99.9 million in sales (see list, page 37).
Beta Bionics last week had its first earnings call as a public company, reporting $20.4 million in net sales for the fourth quarter. It’s forecasting between $80 million and $85 million for 2025, which would be about a 23% to 31% increase.
Investor euphoria has waned a bit as the shares fell 23% in the three trading sessions after the results to $11.71 each and a $507 million market cap.
Lightning Strikes
The co-founder of Beta Bionics understood firsthand the difficulties of living with type 1 diabetes.
Edward “Ed” Damiano’s, a biomedical engineering professor at Boston University, began thinking of an easier way to manage the autoimmune disease after his son David, born in 1999, developed T1D at 11 months old.
Damiano recalled he and his wife having to wake up every few hours at night to check on their son’s blood sugar levels to make sure they weren’t too low or high, Damiano told BU alumni magazine Bostonia.
Damiano now serves as executive chair after stepping down as CEO in 2022 with Saint succeeding him.
Saint, a diabetes device industry veteran, was diagnosed with T1D in 2011.
A month later, he encountered someone speaking about bihormonal glucose control and presenting trial data at a conference hosted by the American Diabetes Association.
The person turned out to be Damiano.
“I was blown away,” Saint said. “I walked up to him and said, ‘How can I help?’”
Together, they collaborated on incorporating Bluetooth technology into the insulin pumps. It would be another 10 years before Saint became involved again with Beta Bionics.
Soon after, Saint and Mike Mensinger, who is currently chief product officer at Beta Bionics, left their jobs at the time to start their own company called Companion Medical.
Companion Medical manufactures a smart insulin pen that sends dose information to a mobile app via Bluetooth. It was acquired by Medtronic PLC (NYSE: MDT) in 2020.
In 2022, Saint was in between projects when he received two separate calls from both a recruiter and Damiano asking if he was interested in joining Beta Bionics. A few months later, he was hired as CEO, Saint said.
“It was just an unbelievable lightning strike of being able to come back and work on this project that I’d known for a decade,” Saint said.
Adaptive Learning Algorithms
The company introduced its signature product called iLet in May of 2023 and recorded $12 million in sales that year.
What differentiates the iLet from existing insulin pumps is how it adapts to the user, according to Saint.
He says that traditional pumps are akin to “glorified syringes.”
“All of the algorithms simply react to your blood sugar and react based on pre-programmed settings,” Saint said. “We added a learning layer above that.”
The iLet’s closed-loop algorithm continuously learns each person’s insulin needs based off real time blood glucose data. It requires only one input, the user’s weight, and calculates insulin doses every five minutes throughout the day and night.
Last year, Beta Bionics had three new product launches.
Among them was the Bionic Circle app, which allows users to invite up to 10 friends or family members to remotely monitor their glucose levels and insulin.
The app was inspired by Dexcom’s similar Follow feature, Saint said.
“It’s a very well-loved feature set in their product, so we thought let’s just supercharge with glucose as well as insulin data, meal announcement data and everything.”
Another announcement was a partnership with Abbott Laboratories to integrate the iLet with Abbott’s FreeStyle Libre 3 Plus system, making it the first automated delivery system integration available for FreeStyle system users in the U.S., according to the company.
IPO Proceeds Funding New Product Development
The company’s technology, which began development in 2003, has had “longstanding support” of its investors. In total, Beta Bionics has raised more than $280 million to date.
Most of the proceeds from the IPO are funding the development of two new products: a patch pump and bihormonal iLet.
The company said it intends to “unlock” a new pool of users who prefer a patch pump design that adheres directly to the skin. Commercialization is expected by 2027.
Beta Bionics is also gearing up to release a bihormonal configuration of the iLet that not only administers insulin, but also glucagon.
Damiano originally envisioned a bihormonal insulin pump when he first started Beta Bionics, but was missing the glucagon aspect, Saint said.
Both hormones are naturally produced by the liver to regulate blood sugar.
Insulin lowers blood sugar down while glucagon prevents it from dipping too low, “similar to the gas and brake in your car,” Saint said.
To help achieve this, Beta Bionics signed an exclusive collaboration and license agreement with Chicago-based Xeris Biopharma Holdings Inc. (Nasdaq: XERS) to be the exclusive provider of the glucagon component for Beta Bionics’ bihormonal pump.
Beta Bionics recently completed pump compatibility testing and made a one-time $3 million milestone payment to Xeris for the formulation, according to a release.
There is no set timeline yet, but the company said it plans to initiate “at least one pre-pivotal clinical trial and pivotal clinical trial” before submitting to the Food and Drug Administration for 510(k) clearance, as well as a new drug application (NDA).
Medtech IPO Drought
Beta Bionics Inc.’s public debut comes after a three-year period with very few medtech IPOs for Orange County.
Last year only saw one medical device company go public, CG Oncology Inc. The Irvine-based cancer researcher raised $380 million, one of the largest IPOs in the region in over three years.
Since medtech IPO activity peaked in 2021 with 47 U.S. companies going public, there have only been six more IPOs, according to J.P. Morgan.
Among them is Sunnyvale-based CeriBell Inc., maker of seizure monitoring devices, which closed a $180.3 million IPO last October and now has a $713 million market cap (Nasdaq: CBLL).
Seeing the success of Ceribell’s IPO combined with investor confidence led Beta Bionics to believe the timing was right to go public, Chief Executive Sean Saint said.
“In our conversations with investors, we believed that there in fact was quite a bit of appetite for new IPOs and we decided to test that out,” Saint said.
—Yuika Yoshida