YARDLEY, PA — Optinose (NASDAQ: OPTN has reported financial results for the quarter ended June 30, 2021, and provided operational updates.
“We are pleased with the progress we made in second quarter 2021 towards our objectives of growing XHANCE and successfully completing our chronic sinusitis program,” stated CEO Peter Miller. “XHANCE net revenue increased 79% compared to second quarter 2020 and we recently completed enrollment in the first of our two pivotal chronic sinusitis clinical trials. We are focused on execution in the second half of 2021 in order to deliver at least $80 million of XHANCE net revenue for the full year and to complete enrollment in the second chronic sinusitis pivotal clinical trial.”
Second Quarter 2021 and Recent Highlights
Total and New XHANCE Prescriptions
The number of total XHANCE® (fluticasone propionate) prescriptions increased by 33% from 62,500 in the second quarter 2020 to 82,900 in the second quarter 2021.
The number of new XHANCE prescriptions increased by 55% from 18,700 in the second quarter of 2020 to 29,000 in the second quarter of 2021.
Enrollment Complete in First Pivotal Chronic Sinusitis Trial
In July, the Company completed patient recruitment in the first of two pivotal clinical trials to evaluate the safety and efficacy of XHANCE as a treatment for patients with chronic sinusitis (CS).
Expert Treatment Algorithm Highlights Role of XHANCE
In June, a new stepped-care treatment algorithm was published in the International Forum of Allergy & Rhinology, “Multidisciplinary consensus on a stepwise treatment algorithm for management of chronic rhinosinusitis with nasal polyps.” It recommends Exhalation Delivery System-fluticasone (EDS-FLU; XHANCE) for the treatment of patients with nasal polyps as a step in between initial care with standard intranasal steroids and before escalation of care to surgery or biologic medicines.
The independent algorithm was informed by evidence-based, peer-reviewed data supporting the use of therapeutic and interventional treatments to arrive at the recommended stepwise care paradigm. The publication discusses considerations in a pathway for care that incorporates several new treatments approved in recent years into a logical stepwise escalation of medical care, including but not limited to standard nasal steroid sprays, EDS-FLU (XHANCE), surgery, implants and biologics.
European Inventor Award 2021 for Industry
In June, Dr. Per Djupesland, co-founder and Chief Scientific Officer of Optinose AS, received the European Inventor Award 2021 in the Industry category from the European Patent Office (EPO) for his invention of the technology that serves as a basis for Optinose Exhalation Delivery System (EDS™) devices.
The European Inventor Award was launched by the EPO in 2006. The finalists and winners are selected by an independent body consisting of international authorities from the fields of business, politics, science, academia and research who examine the proposals for their contribution towards technical progress, social development, economic prosperity and job creation in Europe. The Award is conferred in five categories (Industry, Research, Small and Medium-sized Enterprises, Non-EPO countries and Lifetime achievement). In addition, the public selects the winner of the Popular Prize from among the 15 finalists through online voting.
In July 2021, the Company received approval from regulatory authorities in Mexico to conduct a randomized, proof-of-concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. The study is open for enrollment. This pilot study will evaluate both the magnitude and duration of viral load reduction after a single dose of OPN-019.
Proof-of-concept clinical data is expected to support the Company’s pursuit of grants, partnerships, and/or other sources of capital that will be necessary to fund future development.
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenue for the full year of 2021 to be at least $80 million. In addition, the Company expects full year 2021 XHANCE net revenue per prescription to be greater than $200.
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2021 to be in the range of $137 – $142 million, of which the Company expects stock-based compensation to be approximately $10 million.
Chronic Sinusitis Clinical Trials
The Company has completed enrollment in the first of its two clinical trials evaluating XHANCE as a potential treatment for chronic sinusitis and expects top-line results in the first quarter of 2022. The Company expects to complete patient enrollment in its second clinical trial in the fourth quarter of 2021 and to have top-line results in the second quarter of 2022.
Second Quarter 2021 Financial Results
XHANCE net revenue
The Company generated $18.4 million and $29.3 million in net revenue from sales of XHANCE during the three and six months ended June 30, 2021, respectively. Net revenue from sales of XHANCE increased 79% and 69% during the three and six months ended June 30, 2021 compared to the three and six months ended June 30, 2020, respectively.
Costs and expenses and net loss
For the three and six months ended June 30, 2021, research and development expenses were $8.2 million and $13.4 million, respectively and selling, general and administrative expenses were $27.3 million and $54.5 million, respectively. The net loss for the three and six months ended June 30, 2021 was $23.5 million, or $0.44 per share (basic and diluted) and $49.6 million, or $0.93 per share (basic and diluted), respectively.
The Company had cash and cash equivalents of $93.9 million as of June 30, 2021.
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