Full Press Release Details
FENNEC PHARMACEUTICALS ANNOUNCES SECOND QUARTER
FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
~ Growing Physician Awareness and Usage of
PEDMARK Drove Quarterly Revenue Growth of 98% ~
~Fennec Expands Leadership Team with the Appointment
of Adrian Haigh as Chief Operating Officer ~
~ Management to Host Conference Call Today
Research Triangle Park, NC, August 3, 2023
- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today reported
its financial results for the second quarter ended June 30, 2023 and provided a business update.
"During the second quarter, we continued
to make strong progress with the U.S. commercial launch of PEDMARK , delivering net revenue of $3.3 million, which is
a 98% increase in net revenue over the first quarter of 2023. These results reflect strong growth in patient starts and new account orders,"
said Rosty Raykov, chief executive officer of Fennec Pharmaceuticals. "Further, we are delighted to announce the appointment of
Adrian Haigh, a Fennec board member since 2014, to the position of Chief Operating Officer. Adrian brings significant experience in evaluating
business development opportunities and preparing global commercial operations, and we are pleased to have him on our leadership team."
Appointment of Adrian Haigh as Chief Operating
its leadership team with the appointment of Adrian Haigh as Chief Operating Officer. Adrian has been a board member of Fennec
since 2014 and with his appointment to the management team of Fennec will step down as board member. Adrian recently retired from PTC
Therapeutics where his last role was Senior Vice President and Head of International. Previously, Mr. Haigh served as Chief Operating
Officer at Gentium GmbH where he built and managed the company's commercial and medical affairs organization and was also responsible
for business development, playing a pivotal role in the sale of Gentium to Jazz Pharmaceuticals for $1 billion.
to join Fennec at this critical point in the commercial evolution of the company and to be part of the leadership team that is evaluating
all options for PEDMARK worldwide," said Adrian Haigh. "Further, having been part of Fennec's board
for nearly a decade, I will continue Fennec's unrelenting commitment to enabling rapid access to PEDMARK to all eligible
patients as hearing loss from cisplatin chemotherapy is a permanently disabling and devastating side effect of cancer treatment."
Upcoming Investor Conference
Financial Results for the Second Quarter
Company will host a conference call today, August 3, at 8:30 a.m. ET, to discuss the Company's financial results from the second
quarter, ended June 30, 2023, and provide a business outlook for the remainder of 2023.
the conference call, please register at: 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.fennepharma.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.
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 June 30, 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 | ||||||||
| June 30, | June 30, | |||||||
| 2023 | 2022 | |||||||
| Revenue | ||||||||
| PEDMARK product sales, net | $ | 3,325 | $ | - | ||||
| Cost of products sold | (148 | ) | - | |||||
| Gross profit | 3,177 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | 8 | 1,131 | ||||||
| Selling and marketing | 2,340 | - | ||||||
| General and administrative | 5,495 | 3,878 | ||||||
| Total operating expenses | 7,843 | 5,009 | ||||||
| Loss from operations | (4,666 | ) | (5,009 | ) | ||||
| Other (expense)/income | ||||||||
| Unrealized foreign exchange loss | 5 | 1 | ||||||
| Amortization expense | (73 | ) | (8 | ) | ||||
| Unrealized loss on securities | - | (8 | ) | |||||
| Interest income | 115 | 9 | ||||||
| Interest expense | (825 | ) | (57 | ) | ||||
| Total other (expense)/income | (778 | ) | (63 | ) | ||||
| Net loss | $ | (5,444 | ) | $ | (5,072 | ) | ||
| Basic net loss per common share | $ | (0.21 | ) | $ | (0.19 | ) | ||
| Diluted net loss per common share | $ | (0.21 | ) | $ | (0.19 | ) | ||
| Weighted-average number of common shares outstanding basic | 26,458 | 26,052 | ||||||
| Weighted-average number of common shares outstanding diluted | 26,458 | 26,052 |
Fennec Pharmaceuticals Inc.
(U.S. Dollars in thousands)
| Unaudited | Audited | |||||||
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 14,958 | $ | 23,774 | ||||
| Accounts receivable, net | 2,445 | 1,545 | ||||||
| Prepaid expenses | 457 | 770 | ||||||
| Inventory | 1,439 | 576 | ||||||
| Other current assets | 32 | 63 | ||||||
| Total current assets | 19,331 | 26,728 | ||||||
| Non-current assets | ||||||||
| Deferred issuance cost, net amortization | 106 | 211 | ||||||
| Total non-current assets | 106 | 211 | ||||||
| Total assets | $ | 19,437 | $ | 26,939 | ||||
| Liabilities and shareholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,005 | $ | 2,390 | ||||
| Accrued liabilities | 773 | 2,219 | ||||||
| Total current liabilities | 3,778 | 4,609 | ||||||
| Long term liabilities | ||||||||
| Term loan | 25,000 | 25,000 | ||||||
| PIK interest | 707 | 260 | ||||||
| Debt discount | (321 | ) | (361 | ) | ||||
| Total long term liabilities | 25,386 | 24,899 | ||||||
| Total liabilities | 29,164 | 29,508 | ||||||
| Shareholders'(deficit) equity: | ||||||||
| Common stock, no par value; unlimited shares authorized; 26,411 shares issued and outstanding (2022 -26,361) | 143,345 | 142,591 | ||||||
| Additional paid-in capital | 60,381 | 56,797 | ||||||
| Accumulated deficit | (214,696 | ) | (203,200 | ) | ||||
| Accumulated other comprehensive income | 1,243 | 1,243 | ||||||
| Total shareholders' (deficit) equity | (9,727 | ) | (2,569 | ) | ||||
| Total liabilities and shareholders' (deficit) equity | $ | 19,437 | $ | 26,939 |
| Working capital | Fiscal Period Ended | |||||||
| Selected Asset and Liability Data: | June 30, 2023 | December 31, 2022 | ||||||
| (U.S. Dollars in thousands) | ||||||||
| Cash and equivalents | $ | 14,958 | $ | 23,774 | ||||
| Other current assets | 4,373 | 2,954 | ||||||
| Current liabilities | (3,778 | ) | (4,608 | ) | ||||
| Working capital | $ | 15,553 | $ | 22,120 | ||||
| Selected Equity: | ||||||||
| Common stock and additional paid in capital | 203,726 | 199,388 | ||||||
| Accumulated deficit | (214,696 | ) | (203,200 | ) | ||||
| Shareholders' (deficit) equity | (9,727 | ) | (2,569 | ) |
Cisplatin-Induced Ototoxicity
and other platinum compounds are essential chemotherapeutic agents for the treatment of many pediatric malignancies. Unfortunately, platinum-based
therapies can cause ototoxicity, or hearing loss, which is permanent, irreversible, and particularly harmful to the survivors of pediatric
of ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids or cochlear
implants, which can be helpful for some, but do not reverse the hearing loss and can be costly over time.ii
Infants and young children that are affected by ototoxicity at critical stages of development lack speech and language development
and literacy, and older children and adolescents often lack social-emotional development and educational achievement.iii
PEDMARK (sodium thiosulfate injection)
PEDMARK is the first and only
U.S. Food and Drug Administration (FDA) approved therapy indicated to reduce the risk of ototoxicity associated with cisplatin treatment
in pediatric patients with localized, non-metastatic, solid tumors. It is a unique formulation of sodium thiosulfate in single-dose,
ready-to-use vials for intravenous use in pediatric patients. PEDMARK is also the only therapeutic agent with proven efficacy and safety
data with an established dosing paradigm, across two open-label, randomized Phase 3 clinical studies, the Clinical Oncology Group (COG)
Protocol ACCL0431 and SIOPEL 6.
U.S. and Europe, it is estimated that, annually, more than 10,000 children may receive platinum-based chemotherapy. The incidence of
ototoxicity depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids. There is currently
no established preventive agent for this hearing loss and only expensive, technically difficult, and sub-optimal cochlear (inner ear)
implants have been shown to provide some benefit. Infants and young children that suffer ototoxicity at critical stages of development
lack speech language development and literacy, and older children and adolescents lack social-emotional development and educational achievement.
has been studied by co-operative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, COG ACCL0431 and SIOPEL
6. Both studies have been completed. The COG ACCL0431 protocol enrolled childhood cancers typically treated with intensive cisplatin
therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma,
medulloblastoma, and other solid tumors. SIOPEL 6 enrolled only hepatoblastoma patients with localized tumors.
(sodium thiosulfate injection) is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month
of age and older with localized, non-metastatic solid tumors.
The safety and efficacy of PEDMARK have not been
established when administered following cisplatin infusions longer than 6 hours. PEDMARK may not reduce the risk of ototoxicity when
administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
Important Safety Information
PEDMARK is contraindicated in patients with history
of a severe hypersensitivity to sodium thiosulfate or any of its components.
Hypersensitivity reactions occurred in 8% to
13% of patients in clinical trials. Monitor patients for hypersensitivity reactions. Immediately discontinue PEDMARK and institute appropriate
care if a hypersensitivity reaction occurs. Administer antihistamines or glucocorticoids (if appropriate) before each subsequent administration
of PEDMARK. PEDMARK may contain sodium sulfite; patients with sulfite sensitivity may have hypersensitivity reactions, including anaphylactic
symptoms and life-threatening or severe asthma episodes. Sulfite sensitivity is seen more frequently in people with asthma.
PEDMARK is not indicated for use in pediatric
patients less than 1 month of age due to the increased risk of hypernatremia or in pediatric patients with metastatic cancers.
Hypernatremia occurred in 12% to 26% of patients
in clinical trials, including a single Grade 3 case. Hypokalemia occurred in 15% to 27% of patients in clinical trials, with Grade 3
or 4 occurring in 9% to 27% of patients. Monitor serum sodium and potassium levels at baseline and as clinically indicated. Withhold
PEDMARK in patients with baseline serum sodium greater than 145 mmol/L.
Monitor for signs and symptoms of hypernatremia
and hypokalemia more closely if the glomerular filtration rate (GFR) falls below 60 mL/min/1.73m2.
Administer antiemetics prior to each PEDMARK
administration. Provide additional antiemetics and supportive care as appropriate.
The most common adverse reactions ( 25% with
difference between arms of >5% compared to cisplatin alone) in SIOPEL 6 were vomiting, nausea, decreased hemoglobin, and hypernatremia.
The most common adverse reaction ( 25% with difference between arms of >5% compared to cisplatin alone) in COG ACCL0431 was hypokalemia.
Please see full Prescribing Information for PEDMARK
at: www.PEDMARK.com.
About Fennec Pharmaceuticals