Fennec Pharma(FENC)

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Fennec Pharmaceuticals to Report Full Year and Fourth Quarter 2023 Financial Results on March 21, 2024
Globenewswire· 2024-03-19 10:01
RESEARCH TRIANGLE PARK, N.C., March 19, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the Company will release its full year and fourth quarter 2023 financial results before the opening of the U.S. financial markets on Thursday, March 21, 2024. Management will host a conference call and webcast that day to discuss the Company’s financial and business results. Conference Call & Webcast Detail: Date:Time ...
Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand
Newsfilter· 2024-03-18 01:00
Agreement pairs Norgine's commercial expertise and leading European footprint with PEDMARQSI®, the first and only approved therapy in the European Union and U.K. for reducing the risk of cisplatin-induced hearing loss in pediatric patients with localized, non-metastatic solid tumors Fennec will receive €40 million in upfront and up to €210 million in additional commercial and regulatory milestones, and tiered royalties up to the mid-twenties Enhances Norgine's commitment to bringing transformative therapies ...
Wall Street Analysts See a 64.61% Upside in Adherex Technologies Inc. (FENC): Can the Stock Really Move This High?
Zacks Investment Research· 2024-03-13 14:56
Adherex Technologies Inc. (FENC) closed the last trading session at $9.72, gaining 3.4% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $16 indicates a 64.6% upside potential.The mean estimate comprises five short-term price targets with a standard deviation of $0.71. While the lowest estimate of $15 indicates a 54.3% increase from the current price level, the most optimistic analy ...
Fennec Pharmaceuticals: Great Sales Progress - Not Yet Reflected In Stock Price
Seeking Alpha· 2024-03-07 01:39
FatCamera Fennec Pharmaceuticals – Revenue Guidance and EU Launch Fennec Pharmaceuticals (NASDAQ:FENC) (the Company), is a small cap, commercial-stage biotech company with a single drug, PEDMARK®. PEDMARK is a unique formulation of sodium thiosulfate specifically developed for pediatric patients. PEDMARK is FDA-approved to reduce the risk of ototoxicity or hearing loss associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. The drug is used i ...
Fennec Pharma(FENC) - 2023 Q3 - Quarterly Report
2023-11-08 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from____ to ____ Commission File Number: 001-32295 FENNEC PHARMACEUTICALS INC. (Exact Name of Registrant as Specified in Its Charter) | Briti ...
Fennec Pharma(FENC) - 2023 Q2 - Quarterly Report
2023-08-06 16:00
[PART I: FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%3A%20FINANCIAL%20INFORMATION) This part presents the company's unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and internal controls [Item 1. Condensed Consolidated Financial Statements](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) This section presents Fennec Pharmaceuticals Inc.'s unaudited condensed consolidated financial statements, including the balance sheets, statements of operations, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, significant accounting policies, and financial position for the periods ended June 30, 2023, and December 31, 2022 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202023%20%28Unaudited%29%20and%20December%2031%2C%202022) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and stockholders' deficit at specific dates Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2023 (Unaudited) | December 31, 2022 | | :-------------------- | :------------------------ | :------------------ | | **Assets** | | | | Cash and cash equivalents | $14,958 | $23,774 | | Accounts receivable, net | $2,445 | $1,545 | | Inventory | $1,439 | $576 | | Total current assets | $19,331 | $26,728 | | Total assets | $19,437 | $26,939 | | **Liabilities** | | | | Accounts payable | $3,005 | $2,390 | | Accrued liabilities | $773 | $2,219 | | Total current liabilities | $3,778 | $4,609 | | Term loan | $25,000 | $25,000 | | PIK interest | $707 | $260 | | Total liabilities | $29,164 | $29,508 | | **Stockholders' Deficit** | | | | Total stockholders' deficit | $(9,727) | $(2,569) | - Total assets decreased from **$26,939 thousand** at December 31, 2022, to **$19,437 thousand** at June 30, 2023, primarily driven by a decrease in cash and cash equivalents[7](index=7&type=chunk) - The company's stockholders' deficit significantly increased from **$(2,569) thousand** at December 31, 2022, to **$(9,727) thousand** at June 30, 2023[7](index=7&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20%28Unaudited%29%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section outlines the company's financial performance over specific periods, detailing revenues, expenses, and net loss Three Months Ended June 30, 2023 vs. 2022 (in thousands) | Metric (in thousands) | June 30, 2023 | June 30, 2022 | Change | | :-------------------- | :------------ | :------------ | :----- | | PEDMARK product sales, net | $3,325 | $— | $3,325 | | Gross profit | $3,177 | $— | $3,177 | | Research and development | $8 | $1,131 | $(1,123) | | Selling and marketing | $2,340 | $— | $2,340 | | General and administrative | $5,495 | $3,878 | $1,617 | | Total operating expenses | $7,843 | $5,009 | $2,834 | | Loss from operations | $(4,666) | $(5,009) | $343 | | Interest expense | $(825) | $(57) | $(768) | | Net loss | $(5,444) | $(5,072) | $(372) | | Basic net loss per common share | $(0.21) | $(0.19) | $(0.02) | Six Months Ended June 30, 2023 vs. 2022 (in thousands) | Metric (in thousands) | June 30, 2023 | June 30, 2022 | Change | | :-------------------- | :------------ | :------------ | :----- | | PEDMARK product sales, net | $5,002 | $— | $5,002 | | Gross profit | $4,759 | $— | $4,759 | | Research and development | $12 | $2,568 | $(2,556) | | Selling and marketing | $4,871 | $— | $4,871 | | General and administrative | $9,812 | $5,987 | $3,825 | | Total operating expenses | $14,695 | $8,555 | $6,140 | | Loss from operations | $(9,936) | $(8,555) | $(1,381) | | Interest expense | $(1,623) | $(115) | $(1,508) | | Net loss | $(11,496) | $(8,768) | $(2,728) | | Basic net loss per common share | $(0.43) | $(0.34) | $(0.09) | - Net product sales for PEDMARK® were **$3,325 thousand** and **$5,002 thousand** for the three and six months ended June 30, 2023, respectively, as the product became commercially available in October 2022[8](index=8&type=chunk)[128](index=128&type=chunk)[133](index=133&type=chunk) - Research and development expenses decreased significantly by **$1,123 thousand** (3 months) and **$2,556 thousand** (6 months) year-over-year, primarily because manufacturing costs for PEDMARK® are now capitalized as inventory post-approval, rather than expensed to R&D[128](index=128&type=chunk)[133](index=133&type=chunk) - Selling and marketing expenses were **$2,340 thousand** (3 months) and **$4,871 thousand** (6 months) in 2023, reflecting new commercialization efforts for PEDMARK®[128](index=128&type=chunk)[133](index=133&type=chunk) - Interest expense increased substantially by **$768 thousand** (3 months) and **$1,508 thousand** (6 months) due to higher interest rates and an additional **$20 million** in funded debt from the Petrichor facility[129](index=129&type=chunk)[134](index=134&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Unaudited%29%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030%2C%202023%2C%20and%202022) This section tracks changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit over time Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric (in thousands) | Dec 31, 2022 | Mar 31, 2023 | Jun 30, 2023 | | :-------------------- | :----------- | :----------- | :----------- | | Common Stock Amount | $142,591 | $142,804 | $143,345 | | Additional Paid-in Capital | $56,797 | $57,866 | $60,381 | | Accumulated Deficit | $(203,200) | $(209,252) | $(214,696) | | Total Stockholders' Equity | $(2,569) | $(7,339) | $(9,727) | - The accumulated deficit increased from **$(203,200) thousand** at December 31, 2022, to **$(214,696) thousand** at June 30, 2023, reflecting net losses incurred during the period[10](index=10&type=chunk) - Stock-based compensation for employees contributed **$1,089 thousand** (Q1 2023) and **$2,543 thousand** (Q2 2023) to additional paid-in capital[10](index=10&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202023%20and%202022) This section presents the company's cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (in thousands) | Metric (in thousands) | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :-------------------- | :----------------------------- | :----------------------------- | | Net loss | $(11,496) | $(8,768) | | Net cash used in operating activities | $(9,523) | $(6,246) | | Net cash provided by financing activities | $707 | $61 | | Decrease in cash and cash equivalents | $(8,816) | $(6,185) | | Cash and cash equivalents - End of period | $14,958 | $14,915 | - Net cash used in operating activities increased to **$(9,523) thousand** for the six months ended June 30, 2023, from **$(6,246) thousand** in the prior year, primarily due to a higher net loss and changes in operating assets and liabilities[12](index=12&type=chunk)[137](index=137&type=chunk) - Cash and cash equivalents decreased by **$8,816 thousand** during the six months ended June 30, 2023, ending at **$14,958 thousand**[12](index=12&type=chunk)[135](index=135&type=chunk) - Financing activities provided **$707 thousand** in cash, mainly from the issuance of shares and option exercises[12](index=12&type=chunk)[137](index=137&type=chunk) [Notes to the Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Nature of Business and Going Concern](index=9&type=section&id=1.%20Nature%20of%20Business%20and%20Going%20Concern) Fennec Pharmaceuticals Inc. is a commercial-stage specialty pharmaceutical company focused on PEDMARK®, approved by the FDA and European Commission to reduce ototoxicity in pediatric cancer patients. Despite incurring significant losses and negative operating cash flows, the company believes its current funds, including convertible notes, are sufficient to support commercialization efforts for at least the next twelve months - Fennec Pharmaceuticals Inc. is a commercial-stage specialty pharmaceutical company with one U.S. FDA and European Commission approved product, PEDMARK®, for reducing the risk of ototoxicity associated with cisplatin in pediatric patients[14](index=14&type=chunk) - For the six months ended June 30, 2023, the Company incurred a loss from operations of **$9,936 thousand** and experienced negative cash flows from operating activities of **$9,523 thousand**, with an accumulated deficit of **$214,696 thousand**[16](index=16&type=chunk) - The Company secured **$25,000 thousand** through senior secured floating rate convertible notes (First Closing Note: **$5,000 thousand**, Second Closing Note: **$20,000 thousand**) and may draw up to an additional **$20,000 thousand**[17](index=17&type=chunk)[18](index=18&type=chunk)[19](index=19&type=chunk) - Management believes current funds, including the convertible notes, provide sufficient funding for planned activities, including PEDMARK® commercialization, for at least the next twelve months[21](index=21&type=chunk) [2. Significant Accounting Policies](index=11&type=section&id=2.%20Significant%20Accounting%20Policies) This section details the significant accounting policies used in preparing the interim condensed consolidated financial statements, including the basis of presentation, use of estimates, segment information, stock-based compensation, inventory valuation, revenue recognition for PEDMARK® sales, and policies for trade receivables, cash, financial instruments, R&D costs, credit risk, income taxes, and foreign currency transactions. The adoption of ASU 2016-13 for credit losses had no material impact - The financial statements are prepared in accordance with US GAAP, with all amounts in **thousands of U.S. dollars**, except per share amounts[23](index=23&type=chunk) - The Company operates and manages its business as one operating segment, principally in the United States, with no assets located outside the U.S. as of June 30, 2023[25](index=25&type=chunk) - Revenue from PEDMARK® product sales, commercially available since October 17, 2022, is recognized net of estimated variable consideration (discounts, chargebacks, rebates, co-pay assistance, returns) upon delivery to the customer[32](index=32&type=chunk)[34](index=34&type=chunk) - Inventory costs for PEDMARK® are capitalized post-FDA approval (September 2022); prior manufacturing costs were expensed as R&D. As of June 30, 2023, **$1.4 million** of costs were capitalized as inventory[29](index=29&type=chunk)[44](index=44&type=chunk) Net Product Revenues for PEDMARK® (in thousands) | Period | Gross Product Revenues | Discounts and Allowances | Net Product Revenues | | :----- | :--------------------- | :----------------------- | :------------------- | | 3 Months Ended June 30, 2023 | $3,711 | $(386) | $3,325 | | 6 Months Ended June 30, 2023 | $5,606 | $(604) | $5,002 | PEDMARK® Product Revenue by Customer Type (Percentage of Total) | Customer Type | 3 Months Ended June 30, 2023 | 6 Months Ended June 30, 2023 | | :------------ | :--------------------------- | :--------------------------- | | ASD | 34% | 43% | | McKesson | 12% | 11% | | Subtotal-Specialty Distributors | 46% | 54% | | Direct Customers and those less than 10% | 54% | 46% | [3. Loss Per Share](index=21&type=section&id=3.%20Loss%20Per%20Share) Basic and diluted net loss per share are calculated by dividing net loss by the weighted average number of common shares outstanding. Certain outstanding options and warrants were excluded from diluted EPS calculations as their inclusion would have been anti-dilutive - Basic and diluted net loss per common share were **$(0.21)** for the three months ended June 30, 2023, and **$(0.43)** for the six months ended June 30, 2023[8](index=8&type=chunk) Anti-Dilutive Options and Warrants Excluded from EPS (in thousands) | Instrument | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--------- | :----------------------------- | :----------------------------- | | Options to purchase common shares | 4,887 | 4,337 | | Warrants to purchase common shares | 150 | 39 | [4. Stockholders' Equity](index=21&type=section&id=4.%20Stockholders%27%20Equity) This section details changes in stockholders' equity, including authorized capital, warrants, and activity under the equity incentive plan. Stock-based compensation expense for employees increased significantly, and summaries of stock option and restricted share unit activity are provided - The Company's authorized capital stock consists of an unlimited number of common shares, no par value[61](index=61&type=chunk) - Total stock option expense recognized for employees increased to **$3,632 thousand** for the six months ended June 30, 2023, from **$1,407 thousand** in the prior year[65](index=65&type=chunk) Stock Option Activity (in thousands) | Metric | Outstanding at Dec 31, 2022 | Granted | Exercised | Forfeited | Outstanding at Jun 30, 2023 | | :----- | :-------------------------- | :------ | :-------- | :-------- | :-------------------------- | | Number of Options | 4,539 | 705 | (144) | (213) | 4,887 | | Weighted-Average Exercise Price ($USD) | $5.13 | $8.12 / $8.80 | $4.36 / $5.60 | $6.98 / $7.51 | $5.77 | Restricted Share Units (RSUs) Activity (in thousands) | Metric | Outstanding at Dec 31, 2022 | Awarded | Released | Forfeited | Outstanding at Jun 30, 2023 | | :----- | :-------------------------- | :------ | :------- | :-------- | :-------------------------- | | Number of RSUs | 35 | 362 | (4) | (17) | 376 | [5. Fair Value Measurements](index=24&type=section&id=5.%20Fair%20Value%20Measurements) The Company adopted ASC 820 for fair value measurements, classifying financial assets and liabilities into Level 1, 2, or 3 based on input observability. Cash and cash equivalents are primarily Level 1 and Level 2, while Processa common shares are Level 1 - The Company classifies fair value measurements into Level 1 (quoted market prices), Level 2 (observable market-based inputs), or Level 3 (unobservable inputs)[72](index=72&type=chunk)[73](index=73&type=chunk) Fair Value Measurement at June 30, 2023 (in thousands) | Asset | Level 1 | Level 2 | Level 3 | Total | | :---- | :------ | :------ | :------ | :---- | | Cash and cash equivalents | $3,501 | $11,457 | $— | $14,958 | | Processa common shares | $56 | $— | $— | $56 | - As of June 30, 2023, cash and cash equivalents included **$3,501 thousand** in cash (Level 1) and **$11,457 thousand** in money market investments (Level 2)[74](index=74&type=chunk)[75](index=75&type=chunk) [6. Commitments and Contingencies](index=25&type=section&id=6.%20Commitments%20and%20Contingencies) This section outlines the Company's commitments and contingencies, including an exclusive license agreement with OHSU for PEDMARK® intellectual property, the resolution of two securities class action lawsuits (Chapman v. Fennec and Fisher v. Fennec) in favor of the defendants, ongoing inter partes review (IPR) challenges against PEDMARK® patents by Hope Medical Enterprises, and active ANDA litigation against CIPLA for alleged infringement of PEDMARK® patents - Fennec has an exclusive worldwide license agreement with Oregon Health & Science University (OHSU) for intellectual property related to PEDMARK®, expiring in **2038** in the U.S. for methods of use patents[76](index=76&type=chunk)[78](index=78&type=chunk) - Two federal securities class action lawsuits, Chapman v. Fennec Pharmaceuticals Inc., et al. and Fisher v. Fennec Pharmaceuticals Inc., et al., were dismissed with prejudice, and the cases are now closed[83](index=83&type=chunk)[86](index=86&type=chunk) - Hope Medical Enterprises, Inc. filed Inter Partes Review (IPR) challenges against U.S. Patent No. **10,596,190** (invalidated in April 2023) and U.S. Patent No. **10,792,363** (decision extended to November 2023)[87](index=87&type=chunk)[89](index=89&type=chunk) - The Company is engaged in ANDA litigation against CIPLA Ltd. and CIPLA USA for alleged infringement of PEDMARK® patents (U.S. Patent No. **11,291,728**, U.S. Patent No. **11,510,984**, and U.S. Patent No. **11,617,793**). The suit is ongoing and provides a **30-month stay** on FDA approval for CIPLA's generic[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) - PEDMARQSI (EU brand name for PEDMARK) received European Commission approval in June 2023, granting **10 years** of market exclusivity in Europe under Pediatric Use Marketing Authorization (PUMA)[94](index=94&type=chunk) [7. Term Loans](index=31&type=section&id=7.%20Term%20Loans) The Company entered into a Securities Purchase Agreement (SPA) for up to **$45,000 thousand** in senior secured floating rate convertible notes, with **$25,000 thousand** funded to date. These notes accrue cash interest at prime plus **4.5%** (**12.75%** at June 30, 2023) and PIK interest at **3.5%** per annum, maturing in August 2027. The facility is secured by all Company assets - The Company entered into a SPA for up to **$45,000 thousand** in senior secured floating rate convertible notes, with **$5,000 thousand** from the First Closing Note and **$20,000 thousand** from the Second Closing Note already funded[99](index=99&type=chunk)[100](index=100&type=chunk) - An additional **$20,000 thousand** may be drawn under the SPA before December 31, 2023, upon mutual agreement[101](index=101&type=chunk) - Cash interest accrues at prime plus **4.5%** per annum (**12.75%** at June 30, 2023), and Payment-in-Kind (PIK) interest accrues at **3.5%** per annum, with **$707 thousand** accrued as of June 30, 2023[103](index=103&type=chunk) - The notes are convertible into common shares and mature on **August 19, 2027**. The SPA facility is secured by all of the Company's and its subsidiaries' assets[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [8. Subsequent Events](index=33&type=section&id=8.%20Subsequent%20Events) Subsequent to the reporting period, Adrian Haigh was appointed Chief Operating Officer of Fennec on August 3, 2023, and stepped down from the board - On **August 3, 2023**, Adrian Haigh was appointed Chief Operating Officer of Fennec and stepped down from the Company's board of directors[109](index=109&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the Company's financial condition and results of operations, highlighting the commercial launch of PEDMARK® in the U.S. and its European marketing authorization. It details the financial performance for the three and six months ended June 30, 2023, compared to 2022, emphasizing increased revenue from product sales, shifts in operating expenses due to commercialization, and the impact of new debt on interest expense. The discussion also covers liquidity, capital resources, and outstanding share information - Fennec is a commercial-stage biopharmaceutical company focused on PEDMARK®, which received FDA approval on **September 20, 2022**, and European Commission Marketing Authorization in **June 2023**[112](index=112&type=chunk)[113](index=113&type=chunk) - PEDMARK® is the first and only FDA-approved treatment to reduce the risk of ototoxicity associated with cisplatin in pediatric patients, and it is commercially available in the U.S. since **October 17, 2022**[112](index=112&type=chunk)[119](index=119&type=chunk) - The Company received Orphan Drug Exclusivity for PEDMARK® in **January 2023**, providing **seven years** of market exclusivity until **September 20, 2029**, and holds three patents listed in the FDA's Orange Book expiring in **2039**[116](index=116&type=chunk)[118](index=118&type=chunk) - Net loss for the six months ended June 30, 2023, was approximately **$11.3 million**, increasing from **$8.8 million** in the same period of 2022, with an accumulated deficit of **$214.5 million**[124](index=124&type=chunk) - Cash and cash equivalents totaled **$15.0 million** as of June 30, 2023. The Company believes current funds, including potential additional financing of **$20 million** from Petrichor, are sufficient for at least the next twelve months[124](index=124&type=chunk) Outstanding Share Information (in thousands) | Outstanding Share Type | June 30, 2023 | December 31, 2022 | Change | | :--------------------- | :------------ | :---------------- | :----- | | Common shares | 26,509 | 26,361 | 148 | | Warrants | 150 | 150 | — | | Stock options | 4,887 | 4,539 | 348 | | Total | 31,546 | 31,050 | 496 | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%2E%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable for the Company, indicating no material quantitative or qualitative disclosures about market risk are required - The Company states that Item 3, Quantitative and Qualitative Disclosures About Market Risk, is not applicable[148](index=148&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) The Company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2023. There have been no material changes in internal control over financial reporting during the period - The Chief Executive Officer and Chief Financial Officer concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of **June 30, 2023**[149](index=149&type=chunk) - There have been no material changes in internal control over financial reporting during the period covered by this Quarterly Report[150](index=150&type=chunk) [PART II: OTHER INFORMATION](index=28&type=section&id=PART%20II%3A%20OTHER%20INFORMATION) This part includes disclosures on legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=28&type=section&id=Item%201.%20Legal%20Proceedings) Information regarding legal proceedings is incorporated by reference from Note 6, 'Commitments and Contingencies,' in Part I of this Quarterly Report - Information about legal proceedings is detailed in the Commitments and Contingencies footnote (Note 6) to the unaudited interim condensed consolidated financial statements[151](index=151&type=chunk) [Item 1A. Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) The Company refers readers to the detailed discussion of risk factors in its Annual Report on Form 10-K for the year ended December 31, 2022, and states that no material changes to these risk factors have occurred - Readers should consider the risk factors discussed in the Annual Report on Form 10-K, as no material changes from previously disclosed risk factors are known[152](index=152&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - There were no unregistered sales of equity securities and use of proceeds to report[153](index=153&type=chunk) [Item 3. Defaults Upon Senior Securities](index=29&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities[155](index=155&type=chunk) [Item 4. Mine Safety Disclosures](index=29&type=section&id=Item%204.%20Mine%20Disclosures) This item is not applicable to the Company - The Company states that Item 4, Mine Safety Disclosures, is not applicable[156](index=156&type=chunk) [Item 5. Other Information](index=29&type=section&id=Item%205.%20Other%20Information) On August 3, 2023, the Company issued a press release announcing its financial results for the quarter ended June 30, 2023, which is furnished as Exhibit 99.1 - On **August 3, 2023**, the Company issued a press release announcing financial results for the quarter ended **June 30, 2023**, furnished as Exhibit 99.1[157](index=157&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Quarterly Report, including certifications from the CEO and CFO (Sections 302 and 906 of Sarbanes-Oxley Act), the press release for Q2 2023 financial results, and Inline XBRL documents - Exhibits include certifications from the CEO and CFO (**31.1**, **31.2**, **32.1**), the press release for Q2 2023 financial results (**99.1**), and various Inline XBRL documents (**101.INS**, **101.SCH**, **101.CAL**, **101.DEF**, **101.LAB**, **101.PRE**, **104**)[158](index=158&type=chunk) [Signatures](index=30&type=section&id=Signatures) The Quarterly Report was duly signed on **August 7, 2023**, by Rostislav Raykov, Chief Executive Officer, and Robert Andrade, Chief Financial Officer, in accordance with the Securities Exchange Act of 1934 - The report was signed on **August 7, 2023**, by Rostislav Raykov, Chief Executive Officer, and Robert Andrade, Chief Financial Officer[162](index=162&type=chunk)
Fennec Pharma(FENC) - 2023 Q2 - Earnings Call Transcript
2023-08-06 13:00
Fennec Pharmaceuticals Inc. (NASDAQ:FENC) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Robert Andrade - Chief Financial Officer Rostislav Raykov - Chief Executive Officer Adrian Haigh - Chief Operating Officer Conference Call Participants Chase Knickerbocker - Craig-Hallum Capital Group David Nierengarten - Wedbush Securities Operator Good morning, ladies and gentlemen and welcome to the Fennec Pharmaceuticals Second Quarter 2023 Earnings and Corporate Update Conference Ca ...
Fennec Pharma(FENC) - 2023 Q1 - Quarterly Report
2023-05-11 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from____ to ____ Commission File Number: 001-32295 FENNEC PHARMACEUTICALS INC. (Exact Name of Registrant as Specified in Its Charter) | British C ...
Fennec Pharma(FENC) - 2022 Q4 - Annual Report
2023-03-28 16:00
Product Approval and Market Exclusivity - PEDMARK® received FDA approval on September 20, 2022, making it the first and only treatment approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients[13]. - The company announced the commercial availability of PEDMARK® in the United States on October 17, 2022[13]. - The company received Orphan Drug Exclusivity for PEDMARK® in January 2023, providing seven years of market exclusivity until September 20, 2029[17]. - PEDMARK® is estimated to potentially benefit over 10,000 children annually in the U.S. and Europe receiving platinum-based chemotherapy[20]. - The company has received Orphan Drug Exclusivity, preventing FDA approval of any generic versions for at least 7 years from PEDMARK®'s approval date of September 20, 2022[46]. - The company is pursuing a Pediatric Use Marketing Authorization (PUMA) in the EU, which could provide an additional 10 years of market protection[26]. - The company can apply for Pediatric Marketing Use Authorization (PUMA) for drugs developed exclusively for children, which provides 8 plus 2 years of regulatory protection[92][94]. - The European Orphan Drug Regulation provides eight years of data exclusivity and two years of marketing exclusivity for drugs treating rare conditions affecting five or fewer per 10,000 people in the EU[128]. Intellectual Property and Patent Issues - The company has three patents listed for PEDMARK® in the FDA's Orange Book, with two patents expiring in 2039 and one in 2038[18]. - Hope Medical Enterprises, Inc. filed two petitions for inter partes review (IPR) to invalidate U.S. Patent No. 10,596,190 and U.S. Patent No. 10,792,363 related to PEDMARK®[40]. - The U.S. '190 Patent is set to expire in January 2038, while the U.S. '363 Patent is set to expire in July 2039[45]. - The company expects a decision on the IPR for both patents in May 2023, which can be appealed by the losing party[42]. - The company plans to vigorously defend its intellectual property rights related to PEDMARK®, but an invalidation could adversely affect its market exclusivity[44]. - The company is actively pursuing additional patent applications in the U.S. and internationally for PEDMARK®[18]. - The company must list all patents related to its drug products in the FDA's Orange Book upon NDA approval, which can affect generic competition[96]. Financial Performance and Risks - The company reported a net loss of approximately $23.71 million for the year ended December 31, 2022, and an accumulated deficit of approximately $203.2 million as of the same date[184]. - The company has cash and cash equivalents of $23.8 million available as of December 31, 2022, which is expected to fund operations for at least the next 12 months[189]. - The company has a history of significant losses and has generated limited revenue from product sales since inception, highlighting financial risks[174]. - The company may require additional financing to obtain regulatory approval and commercialize PEDMARK®, which could delay or limit product development[174]. - The company may require additional financing to obtain marketing approval of PEDMARK® and commercialize it abroad[189]. Manufacturing and Supply Chain - The company is reliant on contract manufacturers for PEDMARK® production and has no plans to build in-house manufacturing capabilities[51]. - The company has entered into agreements with suppliers for the active pharmaceutical ingredient (API) and third-party manufacturers for PEDMARK® vials[52]. - The OHSU Agreement for PEDMARK® includes milestone payments and royalties on net sales, with the agreement expiring in 2038 or 8 years from the last patent claim expiration[55][58]. - Compliance with cGMP regulations is mandatory for third-party manufacturers, impacting quality control and assurance[208]. - The FDA issued a Complete Response Letter (CRL) in August 2020 and November 2021 due to deficiencies in the third-party manufacturing facility for PEDMARK®[208]. Regulatory Environment and Compliance - The drug approval process in the U.S. typically takes several years and requires substantial resources, with the review process for marketing applications generally taking 12 to 18 months[71][78]. - Companies must ensure compliance with current Good Manufacturing Practices (cGMP) and may face legal or regulatory actions for non-compliance, including recalls and civil penalties[82][83]. - The company is required to disclose clinical trial results within applicable time periods, with penalties for failure to do so[71]. - The approval process in Canada and the U.S. is considered among the most rigorous in the world, requiring adherence to strict safety, efficacy, and quality standards[72]. - The company is subject to various laws and regulations, including those related to Good Manufacturing Practices, which must be adhered to for pharmaceutical product manufacturing[90]. - The company faces risks related to maintaining regulatory compliance and potential enforcement actions[180]. - Non-compliance with FDA regulations could lead to reputational harm and sanctions, including funding issues and drug effectiveness concerns[209]. - Potential consequences of non-compliance include delays, warning letters, fines, and product recalls[210]. - There is a risk of total or partial suspension of production if regulatory issues persist[211]. Market Competition and Challenges - The biotechnology and pharmaceutical industries are highly competitive, with potential competitors having more resources and experience[60]. - The company is subject to substantial competition in the biopharmaceutical market, which could affect its market position[175]. - The company anticipates substantial regulatory review prior to the commercialization of PEDMARK® outside of the United States[188]. - The ongoing COVID-19 pandemic may impact operations, but has not materially affected the company to date[59]. - The ongoing COVID-19 pandemic poses risks to the company's business operations and financial condition[175]. - The company faces scrutiny regarding drug pricing, particularly for orphan drugs, which could affect its pricing strategies[122]. Research and Development - Research and development expenses decreased to $3.5 million in fiscal year 2022 from $5.0 million in 2021, reflecting a shift towards commercial readiness and launch activities for PEDMARK®[164]. - The company has established relationships with contract research organizations and universities to enhance its drug development capabilities[163]. - Phase 3 clinical trials usually take two to four years to complete and involve several hundred to several thousand patients, making them the most time-consuming and expensive part of the clinical trial program[78]. Sales and Reimbursement - The company emphasizes the importance of securing third-party reimbursement for PEDMARK®, which is critical for sales[27]. - Sales of PEDMARK® will depend on reimbursement by payers, which may be limited or unavailable in certain market segments[178]. - Federal law mandates pharmaceutical manufacturers to pay rebates to state Medicaid programs, with the basic rebate for innovator products set at 23.1% of the average manufacturer price[145]. - Effective January 1, 2024, the cap on rebate amounts for drugs will be eliminated, potentially allowing rebates to exceed the average price received by manufacturers[146]. Legislative and Regulatory Changes - The company anticipates ongoing legislative and regulatory changes in the U.S. healthcare system that could significantly impact its business[116]. - Proposed changes to the Orphan Drug Act may limit benefits for drugs treating more than 200,000 individuals, creating uncertainty for future product approvals[124]. - Pediatric exclusivity can extend marketing protection by an additional six months if pediatric data is submitted in response to FDA requests[125]. - The FDA's Breakthrough Therapy Designation aims to expedite the development of drugs showing substantial improvement over existing therapies for serious conditions[129]. - Fast Track Designation allows for expedited review of drugs addressing unmet medical needs, with a determination made within 60 days of the request[130]. - Priority Review can shorten the review time to six to eight months for drugs that address serious conditions or unmet medical needs[136].
Fennec Pharmaceuticals (FENC) Investor Presentation - Slideshow
2022-11-23 16:33
FENNEC PHARMA ● November 2022 | Corporate Presentation www.fennecpharma.com FEN-1321-v3 1 Safe Harbor Statement 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, timeli ...