YARDLEY, PA — Optinose (NASDAQ: OPTN) recently reported financial results for the quarter ended June 30, 2022, and provided operational updates.
“We reported confirmatory, positive topline results from ReOpen2 in June and are further encouraged by the consistency observed in key secondary and pooled results,” stated CEO Peter Miller. “These data potentially support a new indication for XHANCE as a treatment for chronic sinusitis which we believe could increase the total addressable market for XHANCE by a factor of approximately ten compared to current indication. Our team plans to submit an sNDA by the end of 2022. Our current business is performing well, XHANCE net revenue increased 12% in the second quarter of 2022 compared to second quarter 2021 and increased 21% on a year-to-date basis. We changed our full year 2022 guidance for net revenue because we experienced greater than expected vacancy rates in our sales territories in recent months and greater than expected summer seasonal volume declines. However, we are optimistic about the impact that filling vacant sales territories, fall seasonal volume increases, and new clinical data showing a reduction in acute exacerbations in nasal polyp patients could have on prescriptions.”
Second Quarter 2022 and Recent Highlights
In June, the Company announced that the ReOpen2 clinical trial met both of its co-primary endpoints. A statistically significant improvement was demonstrated in patients with chronic sinusitis who were treated with XHANCE® (fluticasone propionate), a drug-device combination product with the proprietary Exhalation Delivery System™, in the ReOpen2 clinical trial compared to patients receiving the Exhalation Delivery System placebo as measured by both primary endpoints: first, a composite symptom score (comprising nasal congestion, facial pain or pressure, and nasal discharge) measured at week 4 and second, an objective measure of disease in the sinus cavities at week 24 (measured by average of the percentages of opacified volume (APOV) on CT scan across the ethmoid and maxillary sinuses).
“ReOpen2 was the second of two trials studying XHANCE for the treatment of patients with chronic sinusitis, a disease for which there are no FDA-approved drug treatments,” said Ramy Mahmoud, MD, MPH, President of Optinose. “In ReOpen2 we found confirmatory evidence that patients with chronic sinusitis who used XHANCE improved, as measured by both a composite symptom score and as measured by the amount of inflammation in the sinuses themselves. ReOpen2 was exciting news for us and for tens of millions of people suffering from chronic sinusitis and added importantly to the growing body of evidence that may inform use of XHANCE to treat sinonasal disease.”
The safety profile and tolerability of XHANCE in this trial were generally consistent with its currently labelled safety profile. Adverse events occurring at a rate of more than 3% with XHANCE and more common than in the Exhalation Delivery System placebo group were: epistaxis, COVID-19, headache, and depression.
Detailed results from this trial will be submitted for publication in a peer-reviewed journal and for presentation at future medical meetings.
Pooled Results from the ReOpen Program
In July, the Company announced selected pooled results from the ReOpen program.
To inform possible differences in response of patients previously using a standard nasal steroid spray, a pre-planned analysis of pooled data assessed symptom improvement for patients entering the trials with at least moderate symptoms despite reporting use of a standard nasal steroid spray. For this subgroup, patients receiving XHANCE improved more from baseline than patients receiving placebo comparator.
In addition, a pooled analysis was performed to assess change in CT scans, measured by APOV at week 24, for the subgroup of patients receiving XHANCE who had chronic sinusitis without nasal polyps. Compared to patients treated with placebo comparator, XHANCE treatment produced greater reduction in sinus opacification in this subgroup. Differences between active and placebo in 186 mcg or 372 mcg XHANCE treatment groups were similar and nominally statistically significant.
Finally, an analysis of pooled data found that the 372 mcg treatment group achieved a type 1 error controlled statistically significant reduction of 66% in the incidence of exacerbations compared to placebo comparator. Reductions in the number of exacerbations, ranging from 53 to 80%, were found for subgroups of chronic sinusitis patients with or without nasal polyps in the 186 mcg or 372 mcg XHANCE treatment groups in additional pre-planned exploratory analyses that were not type 1 error controlled. Exacerbations were defined as a worsening of at least one of the four cardinal symptoms of chronic sinusitis (nasal congestion/obstruction, rhinorrhea, facial pain/pressure, and loss of sense of smell) lasting at least 3 days accompanied by an escalation in medical care, such as doctor visits or antibiotic or steroid prescription.
Second Quarter 2022 Financial Results
The Company reported $20.6 million in net revenue from sales of XHANCE during the three-month period ended June 30, 2022 an increase of 12% compared to $18.4 million during the three-month period ended June 30, 2021. For the six-month period ended June 30, 2022 the Company reported $35.4 million in net revenue from sales of XHANCE an increase of 21% compared to $29.3 million during the six-month period ended June 30, 2021.
Costs and expenses and net loss
For the three-month period ended June 30, 2022, research and development expenses were $4.3 million and selling, general and administrative expenses were $29.5 million. The net loss for the period was $19.4 million, or $0.23 per share (basic and diluted). For the six-month period ended June 30, 2022, research and development expenses were $9.1 million and selling, general and administrative expenses were $58.9 million. The net loss for the period was $44.7 million, or $0.54 per share (basic and diluted).
The Company had cash and cash equivalents of $78.3 million as of June 30, 2022.
XHANCE Net Revenue and Average Net Revenue per Prescription
The Company expects XHANCE net revenues for the full year of 2022 to be between $85 – $92 million. Previously, the Company expected XHANCE net revenues for the full year of 2022 to be at least $90 million. In addition, the Company expects full year 2022 XHANCE average net revenue per prescription to be at least $220. Previously the Company expected full year 2022 XHANCE average net revenue per prescription to be at least $210.
The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2022 to be in the range of $129 – $134 million, of which the Company expects stock-based compensation to be approximately $9 million.
Previously the Company expected total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2022 to be in the range of $135 – $140 million, of which the Company expected stock-based compensation to be approximately $10 million.
Chronic Sinusitis Supplemental New Drug Application (sNDA)
The Company plans to submit an sNDA by the end of 2022.
On August 10, 2022, the Company reportedly entered into the Third Amendment to the Note Purchase Agreement with Pharmakon (the Third Amendment). The Third Amendment reduced the Company’s December 31, 2022 trailing twelve-month net revenue covenant from $90 million to $85 million.
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