Xeris Biopharma Expands into Glucagon and Rare Disease Markets Following $140M IPO and Projected $120M Annual Net Revenue

On October 20, 2022, U.S. biopharmaceutical company Xeris Biopharma announced the results of its Phase 1 study on subcutaneous (SC) injection of levothyroxine (XP-8121): 60 healthy adults generally tolerated the SC administration of levothyroxine at various doses well.

Data demonstrate that Xeris’s subcutaneous levothyroxine formulation enables once-weekly dosing, thereby improving treatment adherence and avoiding gastrointestinal irritation, thus overcoming the limitations of oral levothyroxine. Xeris has requested a meeting with the FDA and expects to receive feedback by the end of the year.

Xeris Pharmaceuticals is a pharmaceutical company focused on ready-to-use injectable and injectable drug formulations, developing and commercializing new therapies for patients in endocrinology, neurology, and gastroenterology. On June 26, 2018,The company announced an initial public offering of 6.555 million ordinary shares at $15 per share, with net proceeds of approximately $98.3 million.. All shares issued in this offering were sold by Xeris.

Xeris Financing History (Partial)

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Hypoglycemia is one of the risks faced by diabetic patients using insulin. For such patients, mild or moderate hypoglycemic episodes may occur multiple times per month, and severe hypoglycemic episodes may occur multiple times per year. Severe hypoglycemia can lead to cardiovascular disease, seizures, and coma; if not treated promptly, it may even result in death. Therefore, emergency assistance from caregivers, family members, or friends is particularly crucial when symptoms of hypoglycemia appear.

To enhance glucose levels in this patient population more safely and stably, many companies have launched glucagon products. Glucagon is a metabolic hormone secreted by the pancreas that prompts the liver to rapidly convert glycogen into glucose and release it into the bloodstream, thereby raising blood sugar levels.

However, many glucagon products on the marketLow Stability, requiring refrigeration and ready-to-use formulation; prior to administration, it must be reconstituted from powder into a solution for subcutaneous (SC) or intramuscular (IM) injection. Meanwhile, some drugs, due toLow Solubility, requiring large volumes of solvent for dissolution, which results in drug solution volumes that are too large for subcutaneous (SC) or intramuscular (IM) administration, thus necessitating intravenous (IV) infusion. These issues pose inconveniences for patients in emergency situations.In the UK, over 5 million patients using insulin are at risk of severe hypoglycemia, yet only 10–20% of them use glucagon.

To address these issues, Xeris offers solutions through its proprietary XeriSol and XeriJect technology platforms,Ultra-concentrated, low-volume paste formulation.This formulation enables peptides or small molecules to remain soluble at high concentrations in water and achieves solubility of biological macromolecules exceeding 400 mg/mL (compared with 50–250 mg/mL for conventional formulations). Therefore,Xeris’s glucagon product eliminates the need for complex reconstitution and intravenous injection, and remains stable at room temperature.

Xeris’s Gvoke HypoPen is the first FDA-approved auto-injector for the treatment of severe hypoglycemia. Gvoke is available in premixed and ready-to-use formulations, with pediatric (0.5 mg/0.1 mL) and adult (1.0 mg/0.2 mL) dosages, for the treatment of severe hypoglycemia in adults and children aged 2 years and older with diabetes. Studies have shown that with Gvoke,The treatment success rate is 100% in children and 99% in adults.

Leveraging Xeris’s proprietary technology, Gvoke simplifies the preparation and administration of glucagon, enabling patients or caregivers to administer the medication more quickly and easily.

In 2021, the U.S. glucagon market size was approximately $524.58 million. From January 2020 to August 2022,Gvoke's market share has been steadily rising, currently reaching 21.6%.

Gvoke

Image source: Xeris official website

Ogluo is Xeris’s glucagon product for overseas markets. The drug received approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in December 2020 and was launched in select regions on February 11, 2021. In April of the same year, Ogluo also obtained approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA).

In July 2021, Xeris entered into an agreement with Tetris Pharma, a subsidiary of Arecor Therapeutics plc. Under the agreement, Xeris is responsible for product supply, while Tetris Pharma is responsible for the commercialization of Ogluo in the European Economic Area, the United Kingdom, and Switzerland. The market for Ogluo in these target regions is estimated at $1 billion.

October 5, 2021Xeris Announces Completion of Acquisition of Strongbridge Biopharma in a Transaction Valued at Approximately $267 Million in Stock and Contingent Value RightsFollowing the merger, Paul Edick, CEO of Xeris, serves as Chairman and CEO of the combined company. John H. Johnson, CEO of Strongbridge, serves as an independent director of the company.

Strongbridge focuses on the development and commercialization of therapies for rare diseases. Its products include Keveyis, a medication for the treatment of primary periodic paralysis (PPP), and Recorlev, a drug targeting Cushing's syndrome.

KEVEYIS isThe first and currently only FDA-approved drug for the treatment of primary periodic paralysis (PPP).

PPP is a rare genetic disorder that can lead to episodes of muscle weakness or temporary paralysis. Patients typically experience their first episode during childhood, with some individuals experiencing onset as early as age 2 or even younger. The frequency, severity, and duration of these episodes can vary, with attacks lasting for several days in some patients.

Clinical trials have demonstrated that Keveyis can reduce the frequency and duration of PPP episodes, as well as their severity.

Recorlev is a cortisol synthesis inhibitor used to treat endogenous hypercortisolemia in adult patients with Cushing's syndrome. The drug was launched in February 2022.

Endogenous Cushing's syndrome is a rare and potentially fatal endocrine disorder caused by prolonged exposure to high levels of cortisol. This condition typically leads to characteristic signs and symptoms. Its complications include hyperglycemia, diabetes mellitus, hypertension, hypercholesterolemia, and the breakdown of various tissues, including vascular, cutaneous, muscular, and skeletal systems, as well as psychological disorders such as depression, anxiety, and insomnia. The five-year survival rate for untreated patients is only 50%.

Results from two Phase 3 studies demonstrated that Recorlev significantly reduced and normalized mean urinary free cortisol concentrations without the need for dose escalation.Currently, the drug has received orphan drug designation from both the FDA and the European Medicines Agency.

Furthermore, Xeris is planning to expand its currently marketed products into other important indications and uses, and to launch entirely new products using its proprietary formulation technology platforms, XeriSol and XeriJect.

Xeris R&D Pipeline

Image source: Xeris official website

Paul R. Edick joined Xeris Pharmaceuticals in January 2017 as Chairman and Chief Executive Officer. Since then, the company has gone public, raising over $200 million, completed multiple preclinical and clinical studies, established a new corporate headquarters in downtown Chicago, and grown its workforce to more than 100 employees.

Prior to joining Xeris, Edick was a co-founder of 3G Advisors, providing consulting services to the pharmaceutical, healthcare, and healthcare investor communities. From 2008 to 2014, Edick served as Chief Executive Officer of MedPointe Healthcare, Ganic Pharmaceuticals, and Durata Therapeutics, a publicly traded biopharmaceutical company. Additionally, he has served on the boards of directors of several publicly listed pharmaceutical companies.

Paul R. Edick

Image source: Xeris official website

In March 2020, lockdown measures across many regions of the United States were progressively intensified due to the impact of the COVID-19 pandemic. Edick noted that this was a highly stressful period for everyone, particularly for patients with diabetes. “Psychological stress and irregular lifestyles can increase the likelihood of severe hypoglycemia,” Edick stated.

To ensure that patients with diabetes can access glucagon as usual, Xeris has partnered with PillPack, Amazon’s online pharmacy, to offer free delivery of Gvoke PFS. Patients can submit applications through PillPack, and online pharmacists will contact their physicians to obtain prescriptions.Patients with commercial insurance can wait for Gvoke to be delivered free of charge without paying out of pocket.

Therefore, although the proportion of patients visiting endocrinology departments in the first quarter of 2021 was approximately 80% of pre-pandemic levels and the market value of glucagon declined by 6%, Gvoke still maintained steady growth during that quarter. At that time, Gvoke’s share of the overall glucagon market increased by 3 percentage points compared to the fourth quarter of 2019, with total prescriptions rising by 14%. According to the company’s financial report, in the last week of April 2021,Gvoke’s market share increased from 8% to 15%. Additionally, its total retail prescriptions in April rose by 30% compared to the same period last year.

In the second quarter of 2022, Xeris achieved record net product revenue of $25.3 million—an increase of 15% from the first quarter of 2022 and 34% year-over-year. Xeris projects full-year total net revenue to range from $105 million to $120 million.

Meanwhile, Gvoke generated net revenues of $11.5 million, representing an approximately 30% increase compared to the same period in 2021; Gvoke prescriptions surpassed 34,000 for the first time, marking a more than 60% increase over the same period in 2021. As of the end of July, Gvoke’s market share in the retail glucagon market grew to approximately 22%. Keveyis reported second-quarter net revenues of $12.8 million, a 28% increase compared to the same period in 2021. Additionally, Recorlev, launched less than a year ago, achieved net revenues of $1 million, with steady sales growth.