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Beta Bionics Announces Plans for IPO

Orange County is about to see the first initial public offering of 2025.

Irvine-based medical device company Beta Bionics Inc. on Jan. 6 filed an S-1 with the Securities and Exchange Commission to list on the Nasdaq under the symbol “BBNX.”

Beta Bionics plans to raise funds that will go toward new product development, regulatory submissions and expanding manufacturing and sales. The number of shares and pricing has not yet been announced. The $100 million amount is a typical placeholder until closer to the IPO date.

News of the IPO comes just one month after the Business Journal reported on the company raising a $60 million Series E round for the continued development of and commercialization of its automated insulin delivery system, the iLet Bionic Pancreas, which helps people with Type 1 Diabetes (T1D) manage their blood sugar levels.

Beta Bionics commercially launched the product in late 2023 after it received Food and Drug Administration clearance for use in individuals ages six and older with T1D.

The company said it is the first FDA approved product to utilize adaptive algorithms to learn each person’s unique and ever-changing insulin requirements to simplify diabetes management.

“We believe this marks a significant advancement over other insulin delivery technologies by offering a differentiated combination of improved glycemic control and a vastly simplified experience for users and caregivers,” Beta Bionics’ filing said.

The offering is being underwritten by BofA Securities, Piper Sandler, Leerink Partners, Stifel and Lake Street.

Rocky Road to Profitability

Beta Bionics was co-founded in 2015 by Edward “Ed” Damiano, a biomedical engineering professor at Boston University. Damiano’s son David was born in 1999 and developed T1D at 11 months old. The diagnosis motivated Damiano to develop a solution to improve his son’s life.

In 2022, the company announced a new chief executive, Sean Saint, who is a diabetes device industry veteran who himself was diagnosed with T1D in 2011.

Soon after, he co-founded Companion Medical, which manufactures the InPen System, a smart insulin pen that uses bluetooth to send dose information to a mobile app. It was acquired by Medtronic PLC (NYSE: MDT) in 2020.

Beta Bionics’ largest shareholders prior to the offering include Eventide Asset Management, 17%, RTW Investments, 12% and Zone Healthcare Holdings, 11%. Co-founder Damiano has a 9.6% stake.

Since the commercial launch, Beta Bionics’ revenue jumped to $44.7 million for the nine months ended Sept. 30, 2024; in its first year of sales, 2023, the company reported $12 million.

Some analysts note it has incurred significant operating losses over the past two years. Net losses were $25.3 million and $36.6 million for the nine months ended Sept. 30, 2023 and 2024, respectively. The company additionally reported having an accumulated deficit of $278.6 million, as well as $60.9 million in cash and cash equivalents and short-term investments, as of Sept. 30, according to the filing.

Beta Bionics attributes most of those costs to research and development expenses to obtain FDA clearance, as well as increased sales and marketing expenses related to the iLet product launch.

To achieve consistent profitability, the company said it needs to increase sales of its product, increase its sales force and commercialization efforts, and obtain reimbursement coverage from payers, among other things.
“The market opportunity for providing greater automation in insulin delivery technology is large and expected to grow at a moderate rate of growth in the coming years, but the firm faces substantial competition and has significant distribution customer concentration risks,” analyst Donovan Jones wrote in a report for the Seeking Alpha website.
Beta Bionics currently manufactures the iLet device and its accompanying ready-to-fill insulin cartridges at its 50,000-square-foot facility in Irvine, which it moved into in 2020.
The company expects the facility “will have sufficient production capacity to support [its] anticipated clinical and commercial demand for the foreseeable future.”

Expanding into Type 2 Diabetes

Beta Bionics intends on expanding the use of the iLet Bionic Pancreas to treat people with insulin-dependent Type 2 Diabetes (T2D).
The potential market for T2D makes it “a compelling opportunity,” the company said.
Beta Bionics estimates the total addressable market for T2D insulin pumps to be approximately $6 billion with about 36 million people living with the condition within the U.S., according to the Centers for Disease Control and Prevention.
Unlike T1D, an autoimmune disorder that destroys insulin-producing cells in the pancreas, people with T2D can still produce insulin but have something what’s called insulin resistance.

Their bodies don’t respond properly to insulin and need increased or replacement insulin production as a result.

There is no timeline yet for the expansion of the iLet in T2D, but the company said it will conduct studies to obtain additional 510(k) clearance for the new indication.
Beta Bionics has two additional products under development in its pipeline.
The company is in the early stages of creating its own version of a patch pump, or a wearable device designed to adhere directly to the skin and continuously administer insulin without tubing.

Beta Bionics currently has a prototype built and plans to seek FDA 510(k) clearance for the device in T1D and T2D.

Its patch pump will feature one component for the electronics and monitor, and another disposable element for the insulin reservoir, adhesive, insertion device and cannula.

It will utilize the same algorithm the iLet uses to automatically calculate insulin doses based on the user’s weight and continuous glucose monitoring data.

Beta Bionics said it expects to commercialize the patch pump by the end of 2027.

Hitting the Brakes

The company also has plans to add a bihormonal capability to the iLet to administer both insulin and glucagon.

The pancreas naturally produces both hormones to regulate blood sugar. Glucagon converts stored energy back into glucose and releases it into the bloodstream, preventing blood sugar levels from dipping too low.

Low blood sugar, known as hypoglycemia, can lead to tissue and organ damage, seizures and a coma if left untreated.

Currently, there are no commercially available automated devices to raise blood glucose levels when they are too low, according to the company.

Beta Bionics last May announced an exclusive collaboration and license agreement with Chicago-based Xeris Biopharma Holdings Inc. (Nasdaq: XERS) for the future commercialization of the bihormonal iLet.

Under the agreement, Xeris will be the exclusive provider of the glucagon component and allow Beta Bionics to use its XeriSol technology.

“If insulin is like the gas pedal in your car, then glucagon is the brakes,” Saint said in a statement.

“Beta Bionics has always felt that a bi-hormonal glucose control system has real advantages over insulin alone… just like the brakes in your car. Now with this partnership with Xeris, we are ready to take the next step in bringing this system to market.”

Beta Bionics will receive all revenue from any sales of the system and pay Xeris tiered, low double-digit royalties on glucagon sales.

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Yuika Yoshida
Yuika Yoshida
Yuika Yoshida has been a reporter covering healthcare, innovation and education at the Orange County Business Journal since 2023. Previous bylines include JapanUp! Magazine and Stu News Laguna. She received her bachelor's degree in literary journalism from the University of California, Irvine. During her time at UC Irvine, she was the campus news editor for the official school paper and student writer for the Samueli School of Engineering. Outside of writing, she enjoys musical theater and finding new food spots within Orange County.
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