11:03:22 EDT Mon 29 Apr 2024
Enter Symbol
or Name
USA
CA



Fennec Pharmaceuticals Inc
Symbol FRX
Shares Issued 26,411,520
Close 2023-05-10 C$ 10.67
Market Cap C$ 281,810,918
Recent Sedar Documents

Fennec Pharmaceuticals loses $6.05-million (U.S.) in Q1

2023-05-11 10:00 ET - News Release

Mr. Robert Andrade reports

FENNEC PHARMACEUTICALS ANNOUNCES FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

Fennec Pharmaceuticals Inc. has released its financial results for the fiscal quarter ended March 31, 2023, and has provided a business update.

"During the first quarter, we continued to see strong commercial momentum and uptake of Pedmark, further underscoring the significant unmet medical need that exists for pediatric solid tumor cancer patients at risk for developing hearing loss associated with cisplatin treatment. Additionally, we are seeing significant commercial activity in the second quarter as a result of the relationships cultivated with healthcare providers and the pediatric cancer patient community by our commercial team since launch in October 2022," said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "We are pleased with the recent CHMP positive opinion for PEDMARQSI and the opportunity to expand Pedmark's presence and availability to patients in Europe."

Recent Developments and Highlights:

Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of PEDMARQSI for reducing the risk of cisplatin-induced hearing loss (Ototoxicity) in pediatric patients with localized, non-metastatic solid tumors.

Received notification that the U.S. Centers for Medicare & Medicaid Services (CMS) has issued a permanent J-Code (J0208) for Pedmark, which became effective April 1, 2023 and will help facilitate the reimbursement process.

Broad payor coverage in place with the largest commercial payors and Medicaid coverage in place across all fifty states.

The National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines for Adolescent and Young Adult (AYA) Oncology to include Pedmark (sodium thiosulphate injection) in January 2023.

The FDA granted Orphan Drug Exclusivity to Pedmark (sodium thiosulphate injection) in January 2023. The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually. The seven-year market exclusivity for Pedmark began on September 20, 2022, the date of its FDA approval, and continues until September 20, 2029. Additionally, in the approved prescribing label, the FDA has explicitly directed that Pedmark is not substitutable with other sodium thiosulphate products.

Upcoming Investor Event

Annual Meeting of Shareholders: Fennec would like to invite shareholders to attend its Annual General Meeting on Monday, June 12, 2023 at 10:00 a.m. ET, which will be held in person at The Nasdaq Market Site, New York, NY 10036, USA, or online by visiting www.virtualshareholdermeeting.com/FENC2023.

Financial Results for the First Quarter 2023

Cash Position - Cash and cash equivalents were $18.4 million at March 31, 2023 and $23.8 million at December 31, 2022. The decrease in cash and cash equivalents between March 31, 2023, and December 31, 2022, is the result of cash outlays for operating expenses related to the promotion of our product, small amounts of research and development and general and administrative expenses, which were offset by cash inflows from product sales. We anticipate that our cash, cash equivalents and investment securities as of March 31, 2023 will be sufficient to fund our planned operations for at least the next twelve months.

Net Sales - The company recorded net product sales of $1.7 million in the first quarter of 2023. The Company recorded discounts and allowances against sales in the amount of $0.2 million and cost of products sold of $0.1 million. The Company had gross profit of $1.6 million for the first quarter of 2023. In the first quarter of 2022, the Company had no revenues.

Research and Development (R&D) Expenses - Research and development expenses decreased by $1.4 million for the three months ended March 31, 2023, compared to the same period in 2022. The Company's research and development activities for the first three months of 2023 consisted of costs associated with investigator initiated clinical trials. During the same period in 2022 and prior to approval of Pedmark, manufacturing costs pertaining to Pedmark were expensed to R&D expense in the period incurred, and following approval are reflected in inventory.

Selling and Marketing Expenses - Selling and marketing expenses include remuneration of our sales and marketing employees, dollars spent on marketing campaigns (sponsorships, trade shows, presentations, etc.), and any activities to support marketing and sales activities. Selling and marketing expenses for the first quarter of 2023 was $2.5 million.

General and Administrative (G&A) Expenses - G&A expenses increased by $2.2 million over the same period in 2022. Non-cash employee remuneration increased by $0.7 million over same period in 2022. Ongoing product support, professional and legal expenses and increased headcount accounted for the remaining increase.

Net Loss - Net loss for the quarter ended March 31, 2023 was $6.1 million ($0.23 per share), compared to $3.7 million ($0.14 per share) for the same period in 2022.

Q1 2023 CONFERENCE CALL INFORMATION

The Company will host a conference call today, May 11, 2023, at 8:30 a.m. ET, to discuss the Company's financial results from the first quarter, ended March 31, 2023, and provide a business outlook for the remainder of 2023.

To access the conference call, please register via the following link: https://register.vevent.com/register/BIda2814a842e34d0d825731a73c51d74d

Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.fennecpharma.com and proceed to the News & Events/Event Calendar page under the Investors & Media heading. Please connect to the company's website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. A webcast replay of the conference call will also be archived on www.fennecpharma.com for thirty days.

Financial Update

The selected financial data presented below is derived from our unaudited condensed consolidated financial statements, which were prepared in accordance with U.S. generally accepted accounting principles. The complete unaudited condensed consolidated financial statements for the period ended March 31, 2023 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com. All values are presented in thousands unless otherwise noted.

  
 
 Unaudited Condensed Consolidated

  Statements of Operations:

  (U.S. Dollars in thousands except per share amounts)
 Three Months Ended    
                                                              March 31,    March 31,  
                                                                2023         2022     
                                                                                      
Revenue                                                                               
Pedmark product sales, net                                   $   1,677    $       -  
Cost of products sold                                              (95 )          -  
Gross profit                                                     1,582            -  
                                                                                      
Operating expenses:                                                                   
Research and development                                             4        1,437  
Selling and marketing                                            2,531            -  
General and administrative                                       4,317        2,109  
                                                                                      
Total operating expenses                                         6,852        3,546  
Loss from operations                                            (5,270 )     (3,546 )
                                                                                      
Other (expense)/income                                                                
Unrealized foreign exchange loss                                     9           (3 )
Amortization expense                                               (72 )         (7 )
Unrealized loss on securities                                      (30 )        (91 )
Interest income                                                    109            9  
Interest expense                                                  (798 )        (58 )
Total other (expense)/income                                      (782 )       (150 )
                                                                                      
Net loss                                                     $  (6,052 )  $  (3,696 )
                                                                                      
Basic net loss per common share                              $   (0.23 )  $   (0.14 )
Diluted net loss per common share                            $   (0.23 )  $   (0.14 )
Weighted-average number of common shares outstanding basic      26,559       26,019  
Weighted-average number of common shares outstanding diluted    26,559       26,019  
                                                                                     

About Fennec Pharmaceuticals

Fennec Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the development and commercialization of Pedmark to reduce the risk of platinum-induced ototoxicity in pediatric patients. Further, Pedmark received FDA approval in September 2022 and has received Orphan Drug Exclusivity in the U.S. Fennec has a license agreement with Oregon Health and Science University (OHSU) for exclusive worldwide license rights to intellectual property directed to sodium thiosulphate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum chemotherapy, in humans. For more information, please visit www.fennecpharma.com.

We seek Safe Harbor.

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