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Fennec Pharmaceuticals
Reports Full Year and Fourth Quarter 2023 Financial Results and Provides Business Update
2024-03-21
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交易
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BioSpace
引进/卖出
上市批准
临床3期
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Achieved
PEDMARK
® Full-Year 2023 Net Product Sales of $21.3 Million, Including $9.7 Million in Net Product Sales in the Fourth Quarter of 2023 Entered Into Exclusive Licensing Agreement to Commercialize
PEDMARQSI
™ in Europe, Australia and New Zealand for Approximately $43 Million Upfront and Up to Approximately $230 Million in Additional Commercial and Regulatory Milestones, and Tiered Royalties Up to the Mid-Twenties Pro forma fourth quarter cash in excess of $55 million Management to Host Conference Call Today at 8:30 a.m. ET RESEARCH TRIANGLE PARK, N.C., March 21, 2024 (GLOBE NEWSWIRE) --
Fennec Pharmaceuticals Inc.
(NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal year ended December 31, 2023 and provided a business update. “It was an exciting year for
Fennec
given the strong performance with PEDMARK® in the first full fiscal year following its U.S. commercial launch. We are pleased with our execution against strategic plans and our momentum in 2023, which sets the stage for further success in 2024 and beyond. We also received European Commission and U.K. approvals of
PEDMARQSI
™, which led to the recent announcement of an exclusive licensing agreement with
Norgine
for Europe, Australia and New Zealand,” said Rosty Raykov, Chief Executive Officer of
Fennec Pharmaceuticals
. “We have significantly strengthened our balance sheet through the agreement with
Norgine
, and we remain dedicated to further growing our revenues as we expand the availability of
PEDMARK
® to patients and providers globally.” Recent Developments and Highlights: Entered into exclusive licensing agreement to commercialize
PEDMARQSI
™ in Europe, Australia and New Zealand.
Fennec
received approximately $43 million upfront and has the potential to receive up to approximately $230 million in additional commercial and regulatory milestones, and double-digit tiered royalties up to the mid-twenties.
PEDMARQSI
was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the
MHRA
in October 2023. Achieved PEDMARK net product revenue of approximately $9 million and $21 million for the fourth quarter and full year 2023, respectively. Additionally, anticipate continued increasing utilization of the earlier endorsement from the NCCN for
PEDMARK
® in the adolescent and young adult (AYA) population. In January 2024, the FDA issued a public reminder to healthcare providers that PEDMARK (
sodium thiosulfate
injection) is not substitutable with other
sodium thiosulfate
products as explicitly directed in its prescribing label. Financial Results for the Fourth Quarter and Fiscal Year Ended December 31, 2023 Net Sales – Net product sales of $21.3 million in fiscal 2023 compared to $1.5 million in 2022. The Company had gross profit of $20.0 million for fiscal year ended 2023. The increase in sales reflects strong growth in new patient starts and accounts. Cash Position – Cash and cash equivalents were $13.2 million as of December 31, 2023. There was a $10.5 million decrease in cash and cash equivalents between December 31, 2023 and December 31, 2022 as a result of cash outlays for operating expenses related to the promotion and marketing of PEDMARK®, general and administrative expenses and the preparation for the commercial launch of
PEDMARQSI
in Europe. These cash outflows were offset by cash inflows primarily from product sales. In addition, as announced this week, we received approximately $43 million from the licensing of Europe, Australia and New Zealand to
Norgine
. Inclusive of these events, the pro forma December 31, 2023 cash balance is in excess of $55 million. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2023, when coupled with PEDMARK revenue assumptions and the recently announced license agreement for Europe, will be sufficient to fund our planned operations for at least the next twelve months. Research and Development Expenses (R&D) Expenses – R&D expenses decreased by $3.5 million in fiscal 2023 as compared to fiscal 2022. The Company reduced research and development costs when it received FDA approval of
PEDMARK
® in September 2022. The majority of traditional research and development expenses associated with PEDMARK® are now recorded as general and administrative expenses or capitalized into inventory and eventually recorded to costs of product sales. 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. The Company recorded $12.1 million in selling and marketing expenses in fiscal 2023, compared to $2.8 million in fiscal year 2022. General and Administrative (G&A) Expenses – For fiscal 2023, G&A expenses increased by $2.3 million compared to fiscal 2022. Non-cash expenses associated with equity remuneration increased by $1.4 million in fiscal year 2023 over 2022. Payroll and benefits related expenses rose by $1.1 million in fiscal 2023 compared to fiscal 2022. There was an increase in consulting and professional costs of $0.8 million in fiscal 2023 over fiscal 2022. Net Loss – Net losses for the fourth quarter and year ended December 31, 2023, of $2.7 million ($0.10 per share) and $16.0 million ($0.60 per share), respectively, compared to $6.9 million ($0.26 per share) and $23.7 million ($0.90 per share), respectively, for the same periods in 2022. 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 audited, condensed consolidated financial statements for the period ended December 31, 2023, and management's discussion and analysis of financial condition and results of operations, will be available via and All values are presented in thousands unless otherwise noted. Unaudited Consolidated Statements of Operations: (U.S. Dollars in thousands except per share amounts) Three Months Ended Twelve Months Ended December 31, December 31, December 31, December 31, 2023 2022 2023 2022 Revenue PEDMARK product sales, net $ 9,735 $ 1,535 $ 21,252 $ 1,535 Cost of products sold (685 ) (86 ) (1,259 ) (86 ) Gross profit 9,050 1,449 19,993 1,449 Operating expenses: Research and development 32 117 56 3,531 Selling and marketing 3,868 2,785 12,123 2,785 General and administrative 6,968 4,682 20,585 17,722 Total operating expenses 10,868 7,584 32,764 24,038 Loss from operations (1,818 ) (6,135 ) (12,771 ) (22,589 ) Other (expense)/income Unrealized foreign exchange gain (loss) 2 (58 ) 5 (9 ) Amortization expense (70 ) (70 ) (287 ) (149 ) Unrealized gain (loss) on securities 4 (3 ) (39 ) (184 ) Interest income 115 153 441 195 Interest expense (915 ) (744 ) (3,394 ) (978 ) Total other (expense)/income (864 ) (722 ) (3,274 ) (1,125 ) Net loss $ (2,682 ) $ (6,857 ) $ (16,045 ) $ (23,714 ) Basic net loss per common share $ (0.10 ) $ (0.26 ) $ (0.60 ) $ (0.90 ) Diluted net loss per common share $ (0.10 ) $ (0.26 ) $ (0.60 ) $ (0.90 ) Weighted-average number of common shares outstanding, basic 26,833 26,275 26,574 26,275 Weighted-average number of common shares outstanding, diluted 26,833 26,275 26,574 26,275 Unaudited Consolidated Balance Sheets: (U.S. Dollars in thousands) December 31, December 31, 2023 2022 Assets Current assets Cash and cash equivalents $ 13,269 $ 23,774 Accounts receivable, net 8,814 1,545 Prepaid expenses 583 770 Inventory 2,156 576 Other current assets 21 63 Total current assets 24,843 26,728 Non-current assets Deferred issuance cost, net amortization 2,021 211 Total non-current assets 2,021 211 Total assets $ 26,864 $ 26,939 Liabilities and shareholders’ (deficit) equity Current liabilities: Accounts payable $ 3,799 $ 2,390 Accrued liabilities 3,754 2,219 Total current liabilities 7,553 4,609 Long term liabilities Term loan 30,000 25,000 PIK interest 1,219 260 Debt discount (286 ) (361 ) Total long term liabilities 30,933 24,899 Total liabilities 38,486 29,508 Commitments and Contingencies Shareholders’(deficit) equity: Common stock, no par value; unlimited shares authorized; 26,361 shares issued and outstanding (2022 ‑26,014) 144,307 142,591 Additional paid-in capital 60,073 56,797 Accumulated deficit (219,245 ) (203,200 ) Accumulated other comprehensive income 1,243 1,243 Total shareholders’ (deficit) equity (11,622 ) (2,569 ) Total liabilities and shareholders’ (deficit) equity $ 26,864 $ 26,939 Working capital Fiscal Year Ended Selected Asset and Liability Data: December 31, 2023 December 31, 2022 (U.S. Dollars in thousands) Cash and equivalents $ 13,269 $ 23,774 Other current assets 11,574 2,954 Current liabilities (7,553 ) (4,608 ) Working capital $ 17,290 $ 22,120 Selected Equity: Common stock and additional paid in capital 206,380 199,388 Accumulated deficit (219,245 ) (203,200 ) Shareholders’ equity (11,622 ) (2,569 ) About
Cisplatin-Induced Ototoxicity
Cisplatin
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 cancer.i The incidence of
ototoxicity
depends upon the dose and duration of chemotherapy, and many of these children require lifelong hearing aids oricochlear 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. In the 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. PEDMARK 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. Indications and Usage
PEDMARK
® (
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
. Limitations of Use 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: . 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 European Commission approval in June 2023 and U.K. approval in October 2023. PEDMARK has received Orphan Drug Exclusivity in the U.S. For more information, please visit . Forward Looking Statements Except for historical information described in this press release, all other statements are forward-looking. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans respecting PEDMARK®, the market opportunity for and market impact of
PEDMARK
®, its potential impact on patients and anticipated benefits associated with its use, and potential access to further funding after the date of this release. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including the risks and uncertainties that regulatory and guideline developments may change, scientific data and/or manufacturing capabilities may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, unforeseen global instability, including political instability, or instability from an outbreak of pandemic or contagious disease, such as the novel coronavirus (COVID-19), or surrounding the duration and severity of an outbreak, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, our ability to obtain necessary capital when needed on acceptable terms or at all, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2023.
Fennec
disclaims any obligation to update these forward-looking statements except as required by law. For a more detailed discussion of related risk factors, please refer to our public filings available at and . PEDMARK® and
Fennec
® are registered trademarks of
Fennec Pharmaceuticals Inc.
©2024
Fennec Pharmaceuticals Inc.
All rights reserved. Investors: Robert Andrade Chief Financial Officer
Fennec Pharmaceuticals Inc.
+1 919-246-5299 Corporate and Media: Lindsay Rocco Elixir Health Public Relations +1 862-596-1304 lrocco@elixirhealthpr.com i Rybak L. Mechanisms of Cisplatin Ototoxicity and Progress in Otoprotection. Current Opinion in Otolaryngology & Head and Neck Surgery. 2007, Vol. 15: 364-369. ii Landier W. Ototoxicity and
Cancer
Therapy. Cancer. June 2016 Vol. 122, No.11: 1647-1658. iii Bass JK, Knight KR, Yock TI, et al. Evaluation and Management of
Hearing Loss
in Survivors of Childhood and Adolescent Cancers: A Report from the Children's Oncology Group. Pediatric Blood &
Cancer
. 2016 Jul;63(7):1152-1162.
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机构
Fennec Pharmaceuticals, Inc.
諾金有限公司
Medicines & Healthcare Products Regulatory Agency
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适应症
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