Company reports Q3 2024 XHANCE net revenue of $20.4 million, an increase of 3% compared to Q3 2023

Company reports positive inflection in new prescriptions of XHANCE starting in September

Company decreases full year 2024 XHANCE net revenue guidance to be between $75.0 to $79.0 million and increases expected average net revenue per prescription guidance to be approximately $270

Company decreases full year 2024 operating expenses guidance to be between $90.0 to $93.0 million

Conference call and webcast to be held today at 8:00 a.m. Eastern Time

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YARDLEY, Pa., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended September 30, 2024, and provided recent operational highlights.

"While our revenue in third quarter was not in line with our expectations, we believe that we are now observing a clear inflection in new prescription demand," stated CEO Ramy Mahmoud, MD, MPH. "We believe the recent accelerating trend in new prescription demand reinforces the magnitude of the longer-term opportunity. In addition, we believe that our experience in the initial phases of the launch has improved our understanding of the key drivers of adoption and that this experience will help support achievement of our peak year objective."

Third Quarter 2024 and Recent Highlights

New Prescriptions (NRx)

The four-week moving average of weekly NRx ranged between approximately 1,760 to 1,960 for the weeks ended June 28, 2024 through September 6, 2024. With the inflection first observed in September, the moving average increased to approximately 2,300 to 2,500 NRx per week in October (through the week ended October 25) an increase of approximately 20% to 40% percent compared to the prior range. In addition, NRx for the most recent six weeks ending the week of October 25th include the top five ranked weeks for NRx in 2024.

Third Quarter 2024 Financial Results

Total revenues

The Company reported $20.4 million in net revenue from sales of XHANCE during the three-month period ended September 30, 2024, an increase of 3% compared to $19.8 million during the three-month period ended September 30, 2023. For the nine-month period ended September 30, 2024, the Company reported $55.8 million in net revenue from sales of XHANCE, an increase of 9% compared to the nine-month period ended September 30, 2023.

Costs and expenses and net loss

For the three-month and nine-month periods ended September 30, 2024, research and development expenses were $0.9 million and $3.1 million, respectively. Selling, general and administrative expenses were $19.5 million and $64.1 million, respectively, for the three-month and nine-month periods ended September 30, 2024.

The net income for the three-month period ended September 30, 2024 was $0.5 million, or $0.00 per share (diluted). The net loss for the nine-month period ended September 30, 2024 was $21.2 million, or $0.20 per share (diluted).

Balance Sheet

The Company had cash and cash equivalents of $82.5 million as of September 30, 2024.

Financial Guidance

XHANCE Net Revenue

The Company expects XHANCE net revenues for the full year of 2024 to be between $75.0 to $79.0 million. Previously the Company expected XHANCE net revenues for the full year of 2024 to be between $85.0 to $90.0 million.

XHANCE Average Net Revenue per Prescription

The Company expects full year 2024 XHANCE average net revenue per prescription to be approximately $270. Previously the Company expected full year 2024 XHANCE average net revenue per prescription to exceed $250.

Operating Expenses

The Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2024 to be between $90.0 to $93.0 million, of which the Company expects stock-based compensation to be approximately $6.0 million. Previously the Company expected total GAAP operating expenses for 2024 to be between $95.0 to $101.0 million, of which the Company expected stock-based compensation to be approximately $6.0 million.

Company to Host Conference Call

Members of the Company's leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

Participants may access the conference call live via webcast by visiting the Investors section of Optinose's website at http://ir.optinose.com/presentations. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a personal PIN that can be used to access the call. In addition, a replay of the webcast will be available on the Company website for 60 days following the event.

 
OptiNose, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(Unaudited)
         
  Three Months Ended Nine Months Ended
  September 30, September 30,
   2024   2023   2024   2023 
Revenues:        
Net product revenues $20,437  $19,823  $55,807  $51,122 
Total revenues  20,437   19,823   55,807   51,122 
Costs and expenses:        
Cost of product sales $2,065  $2,225  $5,277  $6,502 
Research and development  949   1,281   3,083   4,017 
Selling, general and administrative  19,475   18,011   64,121   60,839 
Total costs and expenses  22,489   21,517   72,481   71,358 
Loss from operations  (2,052)  (1,694)  (16,674)  (20,236)
Other (income) expense  (2,519)  7,600   4,507   5,280 
Net income (loss) $467  $(9,294) $(21,181) $(25,516)
         
Less: undistributed earnings to participating shareholders  (74)  -   -   - 
Net income (loss) - basic $393  $(9,294) $(21,181) $(25,516)
Net income (loss) per share of common stock - basic $-  $(0.08) $(0.15) $(0.23)
Weighted average common shares outstanding - basic  174,328,570   112,230,155   144,900,726   111,996,456 
         
Net income (loss) - basic $393  $(9,294) $(21,181) $(25,516)
Add: Unrealized gain on the fair value of warrants  -   -   (8,700)  - 
Net income (loss) - diluted $393  $(9,294) $(29,881) $(25,516)
Net income (loss) per share of common stock - diluted $-  $(0.08) $(0.20) $(0.23)
Weighted average common shares outstanding - diluted  174,369,875   112,230,155   149,634,133   111,996,456 

OptiNose, Inc.
Condensed Consolidated Balance Sheet Data
(in thousands)
     
  September 30, December 31,
   2024   2023 
  (unaudited)  
Cash and cash equivalents $82,497  $73,684 
Other assets  48,523   34,045 
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