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It seems that indeed BLRX is walking
on the footsteps of GMDA.
Very warm market reaction towards the news!
0.8345+0.0906 (+12.1791%)
As of 01:19PM EDT. Market open.
Volume 180,055
Avg. Volume 174,631
What's up?
And with it you also have no business!
5.29-0.13 (-2.40%)
As of 01:25PM EDT. Market open.
Volume 571,492
Avg. Volume 17,671
When will you learn, a patent is only worthwhile
if and when someone pays you to make use of it.
A lot better results than i had anticipated.
RedHill Biopharma Announces Full-Year 2023 Results and Operational Highlights
https://finance.yahoo.com/news/redhill-biopharma-announces-full-2023-130000273.html
RedHill continues corporate transformation to focus on U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base
Focused externally funded R&D:
Opaganib for nuclear and chemical medical countermeasure (NIH funding): Selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. Nuclear and chemical incident response strategies are characterized by significant government stockpiling of approved agents
Opaganib for Ebola (U.S. Army funding): U.S. Army studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
RHB-107 for COVID-19 (U.S. DoD funding): Selected for inclusion in the 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment; COVID-19 treatment continues to be a multi-hundreds of million-dollar market
RHB-107 for Ebola (U.S. Army funding): RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies
With multiple target indications, opaganib and RHB-107 are novel, oral, host-directed small molecule drugs in advanced clinical development, with demonstrated safety & efficacy profiles, well suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant and easy to administer and distribute
Discussions ongoing with multiple parties regarding strategic business transactions, including potential divestment of certain of our assets and/or commercial operations
Cash balance of $6.5 million as of December 31, 20231; Gross profit of $3.1 million on revenues of $6.5 million and an operating income of $12.6 million during the year ended December 31, 2023, versus operating loss of $42.8 million during the year ended December 31, 2022
TEL AVIV, Israel and RALEIGH, N.C., April 8, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full year 2023 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2023.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The RedHill of today is transformed - focused on predominantly U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base and unburdened by debt - we have a very clear direction and value proposition. We are actively pursuing and in discussions with multiple parties regarding strategic business transactions, including potential divestment of certain of our assets and/or our commercial operations, while we focus on the progression of our two lead R&D candidates, opaganib and RHB-107. Both are advancing in programs that are externally funded, predominantly through U.S. government support, and directed at multiple underserved indications that provide both an aggregated multi-billion global market opportunities and potentially advantageous pathways to approval under the FDA Animal Rule2 for certain indications."
Mr. Ben-Asher continued: "We believe that growing geo-political instability and current regional conflicts are causes for concern regarding increased potential for both nuclear and chemical threats. Governments across the world and global health organizations have been stepping up their efforts to find new options in the face of these devastating possibilities – especially those that can be delivered in challenging circumstances. Opaganib has now been selected by separate U.S. government-funded programs for evaluation as a nuclear and chemical medical countermeasure for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. RHB-107 has been selected for inclusion in the predominantly U.S. Department of Defense (DoD)-funded 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment, for which screening has commenced and first patients are expected to be enrolled imminently. In addition, in U.S. Army studies, both opaganib and RHB-107 have delivered positive results in pre-clinical testing against Ebola – a disease with a more than 50% mortality rate for which innovation in therapy is desperately needed. Opaganib, we believe, became the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival, while both opaganib and RHB-107 showed an in vitro synergistic effect with remdesivir in viral inhibition. Both opaganib and RHB-107 are novel, oral, host-directed small molecule drugs, with demonstrated safety and efficacy profiles, that are well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, being mutation-resistant and easy to administer and distribute."
Financial results for the 12 months ended December 31, 20233
Net Revenues for the year ended December 31, 2023, were $6.5 million, compared to $61.8 million for the year ended December 31, 2022. The decrease was primarily attributable to the divestiture of Movantik. Talicia net revenues for the year ended December 31, 2023, increased to $8.8 million from $7.7 million for the year ended December 31, 2022, driven mainly by a 15% increase in gross revenues, with stable Gross-to-Net. Net revenues for the year ended December 31, 2023, were reduced by ($2.6) million in contra-revenues for Movantik, largely from returns.
Cost of Revenues for the year ended December 31, 2023, was $3.5 million, compared to $33.3 million for the year ended December 31, 2022. This decrease was primarily attributable to the divestiture of Movantik. As a result of this divestiture, both the recognition of revenues and the associated cost of revenues for this product were discontinued starting from February 2, 2023. Additionally, the amortization of the intangible asset related to Movantik was also discontinued as of that date.
Gross Profit for the year ended December 31, 2023, was $3.1 million, compared to $28.5 million for the year ended December 31, 2022, in line with the decrease in Net Revenues and Cost of Revenues as explained above and primarily attributable to the divestiture of Movantik.
Research and Development Expenses for the year ended December 31, 2023, were $3.5 million, as compared to $7.3 million for the year ended December 31, 2022. The difference is attributable to the completion of clinical trials related to COVID-19 and RHB-107, and to ongoing cost-reduction measures.
Selling, Marketing and General and Administrative Expenses for the year ended December 31, 2023, were $31.0 million, as compared to $64.0 million for the year ended December 31, 2022. The difference was primarily attributable to the ongoing cost-reduction measures and to the divesture of Movantik as described above.
Other Income for the year ended December 31, 2023, was $44.1 million, as compared to no other income recognized for the year ended December 31, 2022. The other income was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services fees provided to the buyer of Movantik.
Operating Income for the year ended December 31, 2023, was $12.6 million, compared to operating loss of $42.8 million for the year ended December 31, 2022. The difference is primarily attributable to the changes resulting from the divestiture of Movantik, as detailed above.
Financial Income, net for the year ended December 31, 2023, was $11.3 million, compared to Financial Expenses, net of $28.8 million for the year ended December 31, 2022. The income recognized in the year ended December 31, 2023, was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCR Collateral Management LLC ("HCR") debt in exchange for the transfer of rights to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred, partially offset by financial expenses related to the derivative financial instruments and other financial expenses.
Net Income of $23.9 million for the year ended December 31, 2023, as compared to Net Loss of $71.7 million for the year ended December 31, 2022, primarily attributed to the changes resulting from the sale of Movantik and to the ongoing cost-reduction measures, as detailed above.
Total Assets as of December 31, 2023, were $23 million, as compared to $158.9 million as of December 31, 2022. The decrease was primarily attributable to the sale of Movantik, resulting in the transfer of the rights to Movantik, as well as to a significant decrease in the Trade Receivables balance (attributed to the fact that the receivables as of December 31, 2022, were primarily associated with Movantik).
Total Liabilities as of December 31, 2023, were $21 million, as compared to $207.3 million as of December 31, 2022. This decrease was primarily due to the extinguishment of HCR debt in exchange for the transfer of Movantik rights, assumption of certain liabilities by HCR, and payments made towards pre-closing liabilities related to Movantik. Remaining pre-closing liabilities related to Movantik as of December 2023, are estimated at $4.8 million.
Net Cash Used in Operating Activities for the year ended December 31, 2023, was $35.8 million, compared to $29.2 million for the year ended December 31, 2022. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities.
Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of the net proceeds from offerings and exercise of warrants in the year ended December 31, 2023, and the decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchase.
Cash Balance as of December 31, 2023, was $6.5 million1.
R&D Overview
RedHill's R&D efforts are concentrated on its two lead investigational candidates, opaganib and RHB-107 – with both advancing in programs that are externally funded, predominantly through U.S. government support, and directed at multiple underserved indications that provide both sizeable market opportunities, estimated aggregate to be well in excess of $1 billion globally, and potentially advantageous pathways to approval.
Opaganib's development is focused on a potential role as a nuclear and chemical medical countermeasure in the event of radiation and chemical incidents, while RHB-107 remains focused on the outpatient treatment of COVID-19. Both molecules have also shown promise for potential use in the treatment of the Ebola virus disease, along with other viral pandemic scenarios, and various inflammatory and oncologic conditions.
Both opaganib and RHB-107 are novel, oral, host-directed small molecule drugs with demonstrated safety and efficacy profiles that are ideally suited to nuclear/chemical incidents and viral pandemic scenarios, being viral mutation-resistant and easy to administer and distribute.
Opaganib (ABC294640)4
Opaganib is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with potential for broad activity across radioprotection, cancer, inflammatory and viral conditions. Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Current focuses of opaganib's development are:
Nuclear and chemical medical countermeasures: Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH.
Ebola virus disease: U.S. Army-funded and conducted studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, significantly increasing survival time, and separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability.
Nuclear and Chemical Medical Countermeasures updates
In November 2022, the Company announced acceleration of opaganib's nuclear radiation protection development program, with newly published data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with:
Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival.
Radioprotective capacity in bone marrow, with opaganib showing enhanced survival in mice irradiated with both lethal and half-lethal whole-body radiation.
Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival.
Radioprotective capacity in bone marrow, with opaganib showing enhanced survival in mice irradiated with both lethal and half-lethal whole-body radiation.
In addition, in November 2022, the Company announced additional positive in vivo results from a new pre-clinical study evaluating the effects of opaganib on radiation-induced hematologic and renal toxicity, which suggests that opaganib exerts a protective impact on key hematological and kidney function parameters following total body irradiation (TBI). Development of opaganib as a homeland security nuclear medical countermeasure is currently expected to follow the Animal Rule under which human efficacy studies may not be required, and if approved, may be eligible for a Medical Countermeasure Priority Review Voucher.
In February 2023, the Company announced that the Radiation and Nuclear Countermeasures Program (RNCP), of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, had selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for ARS. As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with us, to test opaganib in established ARS models.
In July 2023, the Company announced that Apogee had been awarded a further $1.7 million in U.S. government funding, via a Small Business Innovation Research (SBIR) grant, which will support research to further the development of opaganib as an MCM for GI-ARS. This grant is in addition and complementary to the multimillion dollar-valued U.S. government RNCP product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development.
In February 2024, the Company announced that the International Journal of Molecular Sciences published data showing that opaganib protects against radiation-induced lung inflammation and fibrosis in an in vivo mouse model of lung damage following exposure to ionizing radiation.
In March 2024, the Company announced that opaganib had been selected by the U.S. government's Chemical Medical Countermeasure Program and chemical countermeasures research program for evaluation as a potential MCM against inhalation Sulfur Mustard exposure. This selection follows opaganib's previous acceptance into the RNCP for ARS development, providing the potential to see broad activity across both radiation and Sulfur Mustard injuries.
Ebola updates
In October 2023, the Company announced that opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) with a 30% mice survival benefit compared to control in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease.
In December 2023, the Company announced that opaganib demonstrated a robust synergistic effect when combined with remdesivir (Veklury® by Gilead Sciences, Inc.), significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro study.
RHB-107 (upamostat)5
A novel investigational broad-acting, host-directed once-daily oral antiviral targeting multiple potential indications with a focus on COVID-19 and other viruses as part of a pandemic preparedness approach. RHB-107 targets human serine proteases involved in preparing the spike protein for viral entry into target cells and inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated demonstrating its clinical safety profile in approximately 200 patients6. Current focus for RHB-107 development is:
COVID-19 outpatient treatment: Accepted for inclusion in the U.S. DoD-supported 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment, with first patient expected to be enrolled imminently
Ebola virus disease: In U.S. Army-funded and conducted studies RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir
COVID-19 updates:
On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and 100% reduction in hospitalization due to COVID-19.
In July 2023, the Company announced that RHB-107 had been accepted for inclusion in the U.S. Department of Defense-supported Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) PROTECT multinational platform trial for early COVID-19 outpatient treatment. The 300-patient Phase 2 study has received FDA clearance. The study is being conducted in the U.S., Thailand, Ivory Coast, South Africa and Uganda, and is estimated to be completed by end of 2024. The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).
In December 2023, the Company announced the receipt of non-dilutive external funding, additional to the previously announced U.S. Government funding, which now covers the entirety of the RHB-107 (upamostat) arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment.
Ebola Virus Disease updates:
As part of a collaboration with the Therapeutic Discovery Branch of the USAMRIID (US Army Medical Research Institute of Infectious Diseases) in-vitro studies against different strains of Ebola virus and additional viral infectious diseases were undertaken. Initial data from high-content imaging assays provided further support for activities of RedHill candidates against these viral diseases.
In December 2023, the Company announced results from a U.S. Army-funded and conducted Ebola virus in vitro study. RHB-107 demonstrated robust synergistic effect when combined with remdesivir (Veklury® by Gilead Sciences, Inc.), significantly improving viral inhibition while maintaining cell viability.
Other R&D updates:
RHB-204: On January 26, 2023, the Company announced that the U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for the granting of a patent covering orphan drug designated RHB-204's oral fixed-dose combination, methods for treating pulmonary Mycobacterium avium Complex (MAC) disease, and kits comprising a supply of fixed-dose combination products for treating pulmonary MAC disease, expected to protect RHB-2047 through 2041.
RHB-102: On February 16, 2023, the Company announced that following a positive pre-MAA meeting it plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking approval for RHB-102 (Bekinda) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV) in adults and children over the age of 12.
RHB-204 and RHB-102 are subject to ongoing commercialization / out-licensing / divestment discussions.
Talicia 2023 Updates
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)8
Talicia continues to be the most prescribed branded agent for H. pylori eradication by U.S. gastroenterologists9.
Total Talicia coverage stood at nearly 200 million American lives as of December 31, 202310.
On August 1, 2023, the Company announced that Gaelan Medical had received marketing approval for Talicia in the UAE and that Gaelan Medical has subsequently placed the first commercial order for Talicia, which was dispatched from the CMO in December 2023.
In September 2023, the Company announced that the FDA approved our Supplemental new drug application (sNDA) for Talicia®, allowing a change to a more flexible three times daily, taken at least 4 hours apart with food, enabling patients to follow a convenient "breakfast, lunch and dinner" dosing routine, which may support increased patient adherence and optimize he potential for successful H. pylori eradication.
In November 2023, Talicia® was granted another five years' market exclusivity under the QIDP designation by the FDA under the GAIN Act. This grant is on top of the three years' exclusivity granted for the approval of Talicia® under section 505(b)(2). Talicia® is protected by its broad intellectual property suite to 2034.
In January 2024, the Company announced that the USPTO issued a new patent covering Talicia® as a method for eradicating H. pylori regardless of BMI. The new patent is expected to provide protection for Talicia® until May 2042.
In March 2024, the Company announced that Talicia had received a new U.S. patent covering its use as an all-in-one treatment of H. pylori infection, providing protection until 2034.
About RedHill Biopharma
RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults11, and Aemcolo®, for the treatment of travelers' diarrhea in adults12. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
More information about the Company is available at www.redhillbio.com / twitter.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the potential divestment of certain of our assets and/or commercial operations, progress of the R&D activities for opaganib and RHB-107, including timing of opaganib's development for Acute Radiation Syndrome and the potential market opportunity for opaganib and RHB-107. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the risk that the potential divestment of certain of our assets and/or commercial operations will not occur or will be delayed, the risk of delay in the R&D activities for opaganib or RHB-107, including the ACESO PROTECT platform trial for early COVID-19 outpatient treatment, the risk that opaganib or RHB-107 are not found to be well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; that the RHB-107 Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
1 Including cash, cash equivalents, short-term bank deposits and restricted cash.
2 The FDA's Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible.
3 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
4 Opaganib is an investigational new drug, not available for commercial distribution.
5 RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
6 https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext
7 RHB-204 is an investigational new drug, not available for commercial distribution.
8 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
9 IQVIA XPO Data on file.
10 © 1998 - 2024 Managed Markets Insight & Technology, LLC. All rights reserved.
11 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
12 Aemcolo® (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.Aemcolo.com.
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Year Ended December 31,
2023
2022
2021
U.S. dollars in thousands
NET REVENUES
6,530
61,800
85,757
COST OF REVENUES
3,459
33,337
49,406
GROSS PROFIT
3,071
28,463
36,351
RESEARCH AND DEVELOPMENT EXPENSES
3,528
7,279
29,498
SELLING AND MARKETING EXPENSES
14,756
35,442
55,623
GENERAL AND ADMINISTRATIVE EXPENSES
16,219
28,586
32,365
OTHER INCOME
44,064
—
—
OPERATING INCOME (LOSS)
12,632
(42,844)
(81,135)
FINANCIAL INCOME
20,889
13,562
51
FINANCIAL EXPENSES
9,605
42,387
16,660
FINANCIAL INCOME (EXPENSES), net
11,284
(28,825)
(16,609)
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE
PERIOD
23,916
(71,669)
(97,744)
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted (U.S. dollars)
0.01
(0.12)
(0.21)
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
December 31,
December 31,
2023
2022
U.S. dollars in thousands
CURRENT ASSETS:
Cash and cash equivalents
5,569
19,968
Bank deposits
—
15
Restricted cash
790
16,000
Trade receivables
2,591
34,521
Prepaid expenses and other receivables
2,801
4,387
Inventory
4,389
11,009
16,140
85,900
NON-CURRENT ASSETS:
Restricted cash
147
150
Fixed assets
193
502
Right-of-use assets
989
6,692
Intangible assets
5,578
65,626
6,907
72,970
TOTAL ASSETS
23,047
158,870
CURRENT LIABILITIES:
Account payable
3,278
4,230
Lease liabilities
718
1,032
Allowance for deductions from revenue
10,654
47,870
Accrued expenses and other current liabilities
4,592
17,949
Borrowing
—
115,216
Payable in respect of intangible assets purchase
—
11,157
19,242
197,454
NON-CURRENT LIABILITIES:
Lease liabilities
455
6,443
Derivative financial instruments
741
2,623
Royalty obligation
540
750
1,736
9,816
TOTAL LIABILITIES
20,978
207,270
EQUITY (CAPITAL DEFICIENCY):
Ordinary shares
21,441
2,835
Additional paid-in capital
388,363
382,625
Accumulated deficit
(407,735)
(433,860)
TOTAL EQUITY (CAPITAL DEFICIENCY)
2,069
(48,400)
TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY)
23,047
158,870
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31,
2023
2022
2021
U.S. dollars in thousands
OPERATING ACTIVITIES:
Comprehensive income (loss)
23,916
(71,669)
(97,744)
Adjustments in respect of income and expenses not involving cash flow:
Share-based compensation to employees and service providers
1,647
5,675
10,212
Depreciation
1,445
2,136
1,914
Amortization of intangible assets
545
6,018
16,235
Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, (see
below)
(56,082)
—
—
Gains from early termination of leases and impairment of fixed assets, net
(543)
—
—
Non-cash expenses related to borrowing and payable in respect of intangible assets purchase
—
33,151
5,366
Fair value (gains) losses on derivative financial instruments and changes in royalty obligation
5,359
(13,422)
5
Loss from modification of warrants terms as part of a new issuance
1,459
—
—
Issuance costs in respect of warrants
2,034
958
—
Exchange differences and revaluation of bank deposits
19
(40)
118
(44,117)
34,476
33,850
Changes in assets and liability items:
Decrease (increase) in trade receivables
31,930
(2,845)
(3,021)
Decrease in prepaid expenses and other receivables
1,586
274
860
Decrease (increase) in inventories
2,387
3,801
(8,285)
Increase (decrease) in accounts payable
(952)
(7,434)
111
(Decrease) in accrued expenses and other liabilities
(13,354)
(2,947)
(3,186)
Increase (decrease) in allowance for deductions from revenue
(37,216)
17,159
12,368
(15,619)
8,008
(1,153)
Net cash used in operating activities
(35,820)
(29,185)
(65,047)
INVESTING ACTIVITIES:
Purchase of fixed assets
(11)
(198)
(115)
Change in investment in current bank deposits
15
8,500
(8,500)
Proceeds from sale of financial assets at fair value through profit or loss
—
—
475
Net cash provided by (used in) investing activities
4
8,302
(8,140)
FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares and warrants, net of issuance costs
13,959
23,806
78,536
Exercise of options into ordinary shares
—
—
4,006
Repayment of payable in respect of intangible asset purchase
(6,555)
(10,878)
(7,397)
Decrease in restricted cash
15,210
—
—
Payment of principal with respect to lease liabilities
(1,175)
(1,475)
(1,683)
Net cash provided by financing activities
21,439
11,453
73,462
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
(14,377)
(9,430)
275
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
(22)
(76)
(96)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
19,968
29,474
29,295
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD
5,569
19,968
29,474
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
138
84
47
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
367
8,182
11,280
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING
ACTIVITIES:
Acquisition of right-of-use assets by means of lease liabilities
270
5,590
303
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $4,697
in 2023 and $534 in 2022) resulting from early termination of lease.
5,413
587
—
Transfer of rights in Movantik® and extinguishment of debt obligations:
Decrease in Intangible asset
(59,503)
Decrease in Inventories
(4,233)
Decrease in Payable in respect of Intangible asset
4,602
Decrease in Borrowing
115,216
Gains from the transfer of the rights in Movantik® and extinguishment of debt obligations
56,082
Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
Cision
Cision
View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-full-year-2023-results-and-operational-highlights-302110455.html
SOURCE RedHill Biopharma Ltd.
After 3 consecutive r/s i wonder how much
wisdom i can achieve from a dry prune that
you are!
A patent is only a patent.
I wager besides the immediate frenzy,
stock will end at no more than +5% from
closing day Friday!
COLLPLANT BIOTECHNOLOGIES REPORTS 2023 FULL YEAR FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE
https://finance.yahoo.com/news/collplant-biotechnologies-reports-2023-full-110000475.html
Regenerative breast implant program large-animal study underway to evaluate commercial-size implants with topline data expected in Q4
Ends 2023 with $26.7 million in cash and cash equivalents
Conference call to be held on Thursday, April 4, 2024 at 10:00 a.m. U.S. EDT
REHOVOT, Israel, April 4, 2024 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived recombinant human collagen (rhCollagen) for tissue regeneration and organ manufacturing, today announced financial results for the full year ended December 31, 2023 and provided a corporate update.
"During 2023, the end of which became a challenging year for our nation, we excelled in the advancement of our key programs," said CollPlant's Chief Executive Officer, Yehiel Tal. "We leveraged our pioneering collagen technology platform and dynamic workforce to strengthen existing business collaborations, and advanced our programs - notably with partner, AbbVie. We progressed the dermal filler candidate, which is now in clinical development, and formed a collaboration with industrial 3D printing leader, Stratasys, to refine the manufacturing scale for our breast implants program. Related to our dermal filler partnership with AbbVie, we achieved an important milestone triggering a $10 million milestone payment that we realized in June 2023."
Mr. Tal continued, "As we begin 2024, we believe we are poised to take advantage of the aesthetic and regenerative market this year with a strong balance sheet, lean operating structure, and support from our partners."
2023 and Recent Corporate Highlights
Collaboration Updates
During 2023, CollPlant made significant progress with its development partner, AbbVie, to advance the dermal and soft tissue filler program toward commercialization.
In June 2023, CollPlant announced the achievement of an important milestone under the AbbVie collaboration which triggered a $10 million payment from AbbVie to CollPlant. Per CollPlant's agreement with AbbVie, CollPlant has the potential to receive additional milestones and option product payments, as well as meaningful royalties on product sales.
In April 2023, CollPlant announced a joint development and commercialization agreement with Stratasys Ltd. to collaborate on the development of a solution to bio-fabricate human tissues and organs using Stratasys' P3 technology-based bioprinter and CollPlant's rhCollagen-based bioinks. The first project under the agreement focuses on the development of a bioprinter specific to the creation of CollPlant's regenerative breast implants. It is meant to be an industrial-scale production solution for CollPlant's regenerative breast implants program. CollPlant's state-of-the-art breast implants are being developed to regenerate an individual's natural breast tissue without eliciting immune response, providing a potentially revolutionary alternative for both aesthetic and reconstructive procedures. Under the agreement, both companies have agreed to cross-promote each other's bioprinting products.
CollPlant remains engaged in partnering discussions with several industry leaders in order to leverage its rhCollagen technology and expertise in 3D bioprinting with the mission to develop novel regenerative medical and aesthetics solutions and related applications.
Regenerative Breast Implants
Our regenerative breast implants are targeting the $2.9 billion global breast implant market. The most common breast augmentation or reconstruction procedures today are based on synthetic silicone breast implantations, an artificial substitution for natural regenerated tissue with risks of complications.
Currently, there are no commercial products that allow regeneration of soft tissues such as the breast. In the U.S. alone, hundreds of thousands of people per year experience adverse events that range from autoimmune symptoms to the very serious breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). CollPlant's rhCollagen-based, 3D-bioprinted breast implants that are comprised of CollPlant's proprietary plant-derived rhCollagen and other biomaterials, are expected to regenerate breast tissue without eliciting immune response, and therefore may provide a revolutionary alternative for aesthetic and reconstructive procedures, including postmastectomy for cancer patients.
In addition, CollPlant's regenerative breast implants can be a novel solution for women in the breast reconstruction and augmentation market, which is sizeable, as it is the second most common plastic surgery procedure that is performed worldwide today.
In January 2023, CollPlant announced the successful completion of a large-animal study for its regenerative breast implants. This preclinical study demonstrated progressive stages of tissue regeneration after three months, as highlighted by the formation of maturing connective tissue and neovascular networks within the implants, with no adverse events reported. This study was followed by additional large-animal studies that were intended to further optimize the implant design and composition. New tissue formation and neovascularization with no adverse tissue reactions were demonstrated confirming previous results.
In December of 2023, CollPlant initiated a large-animal study to evaluate commercial-size, 3D-bioprinted, regenerative breast implants. This study will be used to obtain data that will be used to support subsequent human studies and future product commercialization. CollPlant expects to report topline data from this study in the fourth quarter of this year.
Intellectual Property
In November 2023, CollPlant announced that the U.S. Patent and Trademark Office granted the Company a patent that relates to its photocuring technology and serves as the basis of its photocurable dermal filler product candidate, being developed for the aesthetics market.
In addition, in March 2024, the same patent application received allowance in Brazil. Patents were also granted in Israel and Australia allowing for protection until 2039 in these regions.
This newly issued patent is related to CollPlant's photocuring technology within its photocurable dermal filler product candidate and represents an integral part of the Company's strategy to expand the uses for its novel, rhCollagen technology into new, high-value markets.
Gut-on-a-Chip Tissue Model
Given CollPlant's focus on the medical aesthetics area and its collaboration with AbbVie, it has decided to place its resources on hold directed toward its gut-on-a-chip program for the treatment of ulcerative colitis. The Company highly values this program, and the rationale for this relates to the extensive projected timing to progress the tissue model as it relates to cell collection, as well as other processes that must first be conducted before even beginning testing. Therefore, in line with prioritizing its resources, CollPlant expects to reinitiate this program once its resources are commensurate with the projected timing of this program.
Corporate Governance
In the second quarter of 2023, CollPlant announced that it hired a dedicated expert to lead its Environment, Social and Governance (ESG) effort. CollPlant plans to file its first ESG report in the second quarter which will outline its ESG objectives.
In September 2023, CollPlant announced that it joined the United Nations Global Compact, the world's largest initiative for sustainable and responsible corporate governance. As a new participant of this voluntary leadership platform, CollPlant strengthens its commitment to operate sustainably.
Year-Ended December 31, 2023 Financial Results
GAAP revenues for the year ended December 31, 2023, were $11.0 million and included mainly revenues from AbbVie, CollPlant's business partner. Revenues increased by $10.7 million, compared to $299,000 for the year ended December 31, 2022. The increase is mainly related to the achievement of a milestone under the AbbVie Agreement, which triggered a $10.0 million payment and a $600,000 increase in sales of rhCollagen products.
GAAP cost of revenues for the year ended December 31, 2023, was $2.0 million, compared to $400,000 for the year ended December 31, 2022. The increase in cost of revenues by approximately $1.6 million is mainly due to: (i) approximately $320,000 in royalty expenses to the IIA, mainly relating to the milestone achievement under the AbbVie Agreement, (ii) approximately $711,000 related to bioinks, VergenixFG, and rhCollagen sales, and (iii) approximately $570,000 related to inventory write offs.
GAAP gross profit for the year ended December 31, 2023, was $9.0 million, compared to gross loss of $101,000 for the year ended December 31, 2022.
GAAP operating expenses for the year ended December 31, 2023, were $16.5 million, compared to $17.0 million, for the year ended December 31, 2022. The decrease of $500,000 is mainly attributed to a decrease of $745,000 in general and administrative expenses, mainly comprised of: (i) a decrease of $224,000 in employees' salaries expense, (ii) a decrease of $364,000 in share-based compensation expenses and (iii) income of $140,000 for insurance indemnification, offset by an increase of $229,000 in research and development expenses. On a non-GAAP basis, the operating expenses for the year ended December 31, 2023 were $14.5 million, compared to $15.2 million in the year ended December 31, 2022. Non-GAAP measures exclude certain non-cash expenses.
GAAP financial income, net, for the year ended December 31, 2023, totaled $493,000, compared to $172,000 in the year ended December 31, 2022. The increase in financial income, net, is due to the increase in interest rates and interest received from the Company's short-term cash deposits.
GAAP net loss for the year ended December 31, 2023 was $7.0 million, or $0.62 basic loss per share, compared to a net loss of $16.9 million, or $1.53 basic loss per share, for the year ended December 31, 2022. Non-GAAP net loss for the year ended December 31, 2023, was $5.2 million, or $0.46 basic loss per share, compared to $15.2 million loss, or $1.37 basic loss per share, for the year ended December 31, 2022.
Balance Sheets and Cash Flow
The Company's cash and cash equivalents balance as of December 31, 2023, was $26.7 million.
Cash used in operating activities was $2.8 million during the year ended December 31, 2023, compared to $13.7 million for the year ended December 31, 2022. Cash used during the year ended December 31, 2023 includes the $10 million milestone payment from AbbVie.
Net cash used in investing activities was $1.2 million during the year ended December 31, 2023 compared to $28.9 million in net cash that was provided by investing activities during the year ended December 31, 2022. The decrease is mainly attributed to repayment and investment in short-term cash deposits during the year ended December 31, 2022.
Cash provided by financing activities was $1.1 million for the year ended December 31, 2023 compared to $1.9 million in the year ended December 31, 2022. Cash provided by financing activities is attributed to proceeds from the exercise of warrants and options into shares.
Conference call information
To participate in the conference call, please use the dial-in information below:
U.S. investors: 1-877-407-9716
Investors outside of the U.S.: 1-201-493-6779
Israel investors: 1-809-406-247
Conference ID: 13744114
Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time:
https://callme.viavid.com/viavid/?callme=true&passcode=13728588&h=true&info=company&r=true&B=6
Webcast information
A live webcast will also be available in listen-only mode and can be accessed here or via the link to be posted on the News & Events section of the CollPlant Investor relations website. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's website for a limited time.
Submit questions to management in advance of the call and webcast
To ask management a question ahead of the call, please email Dan Ferry at LifeSci Advisors LLC up until 24 hours before the event at daniel@lifesciadvisors.com.
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
26,674
$
29,653
Restricted deposit
241
23
Trade receivables, net
-
9
Other accounts receivable and prepaid expenses
393
543
Inventories
714
1,430
Total current assets
28,022
31,658
Non-current assets:
Restricted deposit
57
188
Operating lease right-of-use assets
3,070
2,711
Property and equipment, net
2,789
2,966
Intangible assets, net
188
245
Total non-current assets
6,104
6,110
Total assets
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share data)
December 31,
2023
2022
Liabilities and shareholders' equity
Current liabilities:
Trade payables
$
980
$
1,133
Operating lease liabilities
624
529
Accrued liabilities and other payables
1,647
1,443
Total current liabilities
3,251
3,105
Non-current liabilities:
Operating lease liabilities
2,535
2,382
Total non-current liabilities
2,535
2,382
Total liabilities
5,786
5,487
Commitments and contingencies
Shareholders' Equity:
Ordinary shares, NIS 1.5 par value - authorized: 30,000,000 ordinary shares
as of December 31, 2023 and , 2022; issued and outstanding: 11,452,672
and 11,186,481 ordinary shares as of December 31, 2023 and 2022,
respectively
4,982
4,873
Additional paid in capital
121,068
118,099
Accumulated other comprehensive loss
(969)
(969)
Accumulated deficit
(96,741)
(89,722)
Total shareholders' equity
28,340
32,281
Total liabilities and shareholders' equity
$
34,126
$
37,768
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
Year ended December 31,
2023
2022
2021
Revenues
$
10,959
$
299
$
15,641
Cost of revenues
1,991
400
2,005
Gross profit (loss)
8,968
(101)
13,636
Operating expenses:
Research and development
10,484
10,255
7,631
General, administrative and marketing
5,996
6,741
5,940
Total operating income (loss)
(7,512)
(17,097)
65
Financial income, net
493
172
172
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Basic net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Diluted net income (loss) per ordinary share
$
(0.62)
$
(1.53)
$
0.02
Weighted average number of ordinary shares used in
computation of basic net income (loss) per share
11,389,168
11,033,310
9,968,972
Weighted average number of ordinary shares used in
computation of diluted net income (loss) per share
11,389,168
11,033,310
11,966,788
COLLPLANT BIOTECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Cash flows from operating activities:
Net income (loss)
$
(7,019)
$
(16,925)
$
237
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Loss on sale of property and equipment
18
-
-
Depreciation and amortization
1,102
1,076
773
Accrued interest
(28)
(87)
(151)
Share-based compensation to employees and consultants
1,937
2,174
1,597
Exchange differences on cash and cash equivalents
379
608
(143)
Remeasurement of Derivatives liability
-
-
(28)
Changes in assets and liabilities:
Decrease in trade receivables
9
261
560
Decrease (increase) in inventories
749
(312)
181
Decrease (increase) in other receivables and prepaid expenses
150
(119)
(185)
Decrease in operating lease right-of-use assets
527
461
400
Increase (decrease) in trade payables
(153)
99
236
Decrease in operating lease liabilities
(638)
(916)
(337)
Increase (decrease) in accrued liabilities and other payables
204
14
(464)
Decrease in deferred revenues
-
(32)
(175)
Net cash provided by (used in) operating activities
(2,763)
(13,698)
2,501
Cash flows from investing activities:
Capitalization of intangible assets
-
(42)
(161)
Purchase of property and equipment
(954)
(1,274)
(1,428)
Proceed from short term deposit
-
50,238
-
Investment in restricted deposits
(270)
-
-
Investment in deposits
-
(20,000)
(30,000)
Proceeds from sale of property and equipment
68
-
33
Net cash provided by (used in) investing activities
(1,156)
28,922
(31,556)
Cash flows from financing activities:
Proceeds from issuance of shares and warrants less issuance expenses
-
-
32,743
Exercise of options and warrants into shares
1,108
1,874
6,017
Net cash provided by financing activities
1,108
1,874
38,760
Effect of exchange rate changes on cash and cash equivalents and restricted deposits
(379)
(608)
143
Net increase (decrease) in cash and cash equivalents and restricted deposits
(3,190)
16,490
9,848
Cash and cash equivalents and restricted cash at the beginning of the year
29,864
13,374
3,526
Cash and cash equivalents and restricted deposits at the end of the year
$
26,674
$
29,864
$
13,374
COLLPLANT BIOTECHNOLOGIES LTD.
APPENDICES TO CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands)
Year ended December 31,
2023
2022
2021
Supplemental discloser of non-cash activities:
Right of use assets recognized with corresponding lease liabilities
$
886
$
219
$
557
Classification of issuance costs liability to equity
$
-
$
-
$
50
Capitalization of Share-based compensation to inventory
$
33
$
37
$
-
Supplemental discloser of cash activities:
Cash paid during the year for taxes
$
8
$
31
$
-
Reconciliation of cash, cash equivalents and restricted cash at the end of the year
Cash and cash equivalents
$
26,674
$
29,653
$
13,148
Restricted deposits short term
-
23
13
Restricted deposits long term
-
188
213
Total cash and cash equivalents and restricted deposits
$
26,674
$
29,864
$
13,374
CollPlant Biotechnologies Ltd.
Reconciliation of GAAP to Non-GAAP Financial Measures
(U.S. dollars in thousands, except per share data)
Year ended December 31,
2023
2022
GAAP operating expenses:
$
16,480
$
16,996
Change of operating lease accounts
-
455
Share-based compensation to employees, directors and consultants
(1,937)
(2,211)
Non-GAAP operating expenses:
14,543
15,240
GAAP operating loss
(7,512)
(17,097)
Change of operating lease accounts
-
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP operating loss
(5,575)
(15,341)
GAAP Net loss
(7,019)
(16,925)
Change of operating lease accounts
(111)
(455)
Share-based compensation to employees, directors and consultants
1,937
2,211
Non-GAAP Net loss
$
(5,193)
$
(15,169)
GAAP basic and diluted loss per ordinary share
$
(0.62)
$
(1.53)
NON- GAAP basic and diluted loss per ordinary share
$
(0.46)
$
(1.37)
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. The Company's products are based on its rhCollagen (recombinant human collagen) produced with CollPlant's proprietary plant based genetic engineering technology. These products address indications for the diverse fields of tissue repair, aesthetics, and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.
In 2021 CollPlant entered into a development and global commercialization agreement for dermal and soft tissue fillers with Allergan, an AbbVie company, the global leader in the dermal filler market.
For more information about CollPlant, visit http://www.collplant.com.
Use of Non-US GAAP ("non-GAAP")
Financial results for 2023 and 2022 are presented on both a GAAP and a non-GAAP basis. GAAP results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The release contains certain non-GAAP financial measures for operating costs and expenses, operating income (or loss), net income (or loss) and basic and diluted net income (or loss) per share that exclude the effects of non-cash expense for share-based compensation to employees, directors and consultants, and change in operating lease accounts. CollPlant's management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company's performance that enhances management's and investors' ability to evaluate the Company's operating costs, net income (or loss) and income (or loss) per share, and to compare them to historical Company results.
The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company's business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.
For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" later in this release. This accompanying table has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.
The Company's consolidated financial statements for the year ended December 31, 2023, are presented in accordance with generally accepted accounting principles in the U.S.
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at www.sec.gov and posted on the Company's investor relations website at http://ir.collplant.com/. The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to CollPlant Investor Relations at 4 Oppenheimer, Weizmann Science Park, Rehovot 767104, Israel or by phone at +972-73-232 5600.
Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients
https://finance.yahoo.com/news/fite-submits-fda-ind-application-110000607.html
Namodenoson demonstrated anti-fibrosis, anti-steatosis and anti-inflammatory effects in former Phase IIa study
Patient enrolment for Phase IIb study is ongoing in Europe and Israel
RAMAT GAN, Israel, April 03, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH), for the Company’s ongoing Phase IIb clinical study.
Can-Fite’s drug candidate, Namodenoson, has been shown to reduce hepatic steatosis, inflammation, and fibrosis, as well as body weight reduction, in a Phase IIa clinical study where data have been already published in a peer scientific journal (Link to Manuscript). Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.
The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH. The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint. Eligible subjects are randomly assigned in a 2:1 ratio to oral doses of Namodenoson 25 mg every 12 hours or a matching placebo for 36 weeks.
"We are eager to look at the therapeutic effect of Namodenoson in patients with MASH," said Motti Farbstein, chief executive officer of Can-Fite. "Prior human data showed that treatment with Namodenoson leads to significant anti-MASH effects. Namodenoson’s novel liver-protective mechanism of action provides a unique opportunity to potentially improve inflammation and reduce hepatic steatosis and fibrosis which may provide important therapeutic benefits for patients."
Rates of MASH are increasing in the United States in concert with increasing rates of obesity and diabetes and is estimated to affect 2-5% of adult Americans. By 2028, Vantage Market Research estimates the addressable pharmaceutical market for MASH will reach $21.9 billion in size. In March 2024, Madrigal Pharmaceuticals announced FDA approval of Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis, potentially paving the way for more drugs that target this huge market.
Evogene and The Kitchen FoodTech Hub by Strauss Group Established Finally Foods Ltd. - Revolutionizing Protein Production in Plants for the Food Industry
https://finance.yahoo.com/news/evogene-kitchen-foodtech-hub-strauss-110000794.html
Finally Foods is financed by the Israeli Innovation Authority (IIA) and The Kitchen Hub, and will be granted a license to utilize Evogene's AI technology
REHOVOT, Israel, April 2, 2024 /PRNewswire/ -- Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company targeting to revolutionize life-science-based product discovery and development utilizing cutting edge computational biology technologies, across multiple market segments and The Kitchen FoodTech Hub (TKH), the foodtech incubator and investment arm of Israeli food giant Strauss Group, have jointly announced the establishment of Finally Foods Ltd.
'Finally Foods' is an AI-driven company specializing in molecular farming for the food sector, committed to providing sustainable alternative sources to animal-based proteins. The company's mission is to modify plants as "bioreactors" to produce these proteins efficiently and environmentally responsibly. Leveraging Evogene's GeneRator AI technology, the company aims for short R&D cycles and rapid time-to-market.
According to average market reports, the global alternative proteins market was valued at around USD 17.6 billion in 2022, with an anticipated average CAGR of 12%, expected to reach USD 55 billion by 2032[1]. 'Finally Foods' is poised to capture a share in this growing sector, leveraging the revolutionary potential of molecular farming – an efficient and environmentally friendly method for producing valuable proteins.
'Finally Foods' has secured pre-seed funding from TKH and the Israeli Innovation Authority (IIA). Evogene holds approximately 40% stake in the company, with the remaining ownership divided among TKH and the founding team – CEO Dafna Gabbay, a seasoned entrepreneur, and CTO Dr. Basia J. Vinocur, an expert in agricultural biotechnology.
Ofer Haviv, President & CEO of Evogene, expressed his enthusiasm for this new venture, stating, "We are thrilled to embark on this new segment, marking a milestone for Evogene as we continue to drive innovation and growth in the Life Science industry. By harnessing the power of our GeneRator AI tech-engine, molecular farming has the potential to revolutionize the food industry and promote healthier diets worldwide."
"'Finally Foods' is one of the rare cases where we see an extremely strong founding team, in Dafna and Basia, coupled with a proven technology platform based on the leading AI engine of Evogene" said Amir Zaidman, Chief Business Officer of The Kitchen Hub. "Establishing the company under the framework of The Kitchen and investing the pre-seed round was an easy decision in this case."
Dafna Gabbay, Co-Founder & CEO of Finally Foods, expressed her confidence, stating, "I believe that with Evogene's cutting edge technology, TKH's leading position in the FoodTech industry and with Dr. Vinocur's vast experience – 'Finally Foods' has full potential to emerge as a promising company in the alternative proteins sector. Molecular farming represents a catalyst towards global food security and a more sustainable future, and I am proud to lead 'Finally Foods' to take an important part towards supporting this crucial vision for the world."
About Evogene:
Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN) is a computational biology company leveraging big data and artificial intelligence, aiming to revolutionize the development of life-science-based products by utilizing cutting-edge technologies to increase the probability of success while reducing development time and cost.
Evogene established three unique tech-engines - MicroBoost AI, ChemPass AI and GeneRator AI. Each tech-engine is focused on the discovery and development of products based on one of the following core components: microbes (MicroBoost AI), small molecules (ChemPass AI), and genetic elements (GeneRator AI).
Evogene uses its tech-engines to develop products through strategic partnerships and collaborations, and its five subsidiaries including:
1. Biomica Ltd. (www.biomicamed.com) developing and advancing novel microbiome-based therapeutics to treat human disorders powered by MicroBoost AI;
2. Lavie Bio Ltd. (www.lavie-bio.com) - developing and commercially advancing, microbiome based ag-biologicals powered by MicroBoost AI;
3. AgPlenus Ltd. (www.agplenus.com) -developing next generation ag chemicals for effective and sustainable crop protection powered by ChemPass AI;
4. Canonic Ltd. (www.canonicbio.com) – developing medical cannabis products based on decoding plant genetics for optimized therapeutic effect powered by GeneRator AI; and
5. Casterra Ag Ltd. (www.casterra.co)– developing and marketing superior castor seed varieties producing high yield and high-grade oil content, on an industrial scale for the biofuel and other industries powered by GeneRator AI.
For more information, please visit: www.evogene.com.
About The Kitchen Hub:
Founded in 2015 by the Strauss-Group as a part of the Israeli Innovation Authority incubators' program, The Kitchen is a seed investor and a FoodTech focused incubator.
The Kitchen addresses global food challenges by harnessing Israel's renowned innovation ecosystem. We strive to make the world's food chain more productive, affordable, sustainable and healthy by investing in and nurturing cutting-edge technology startups.
Some examples of our areas of interest are: improved agricultural processes, supply chain technologies, efficient food processing, sensors for food safety and quality, prolonged shelf life and reduction of food spoilage, smart packaging, ingredients and products with new health benefits, improved nutritional profiles, reduction of environmental footprint and more.
In addition to a capital investment, the incubator provides the portfolio companies with benefits such as: close mentorship from the incubator's team; access to expertise and know-how from within the Strauss-Group and its partners; connections with global F&B companies and access to international investors.
Our vision is: Better Industry; Better Food; Better World
We believe that technological innovation can overcome the challenges of the food industry and are teaming up with the best FoodTech entrepreneurs to turn our vision into a reality.
More on http://www.TheKitchenHub.com/
About Finally Foods Ltd:
Finally Foods Ltd. is a new AI-driven company specializing in molecular farming for the food sector. It was co-founded by Dafna Gabbay, CEO, a seasoned entrepreneur, and Dr. Basia J. Vinocur, CTO an expert in agricultural biotechnology. The company was formed in collaboration with Evogene Ltd., a leading computational biology company and The Kitchen FoodTech Hub (TKH), the FoodTech incubator and the investment arm of the Strauss Group. Finally Foods produces animal-based proteins by modifying plants to serve as "bioreactors", leveraging Evogene's AI technology. Its first target protein is Casein.
More on http://www.finally-foods.com
RedHill Biopharma Announces $1.25 Million Registered Direct Offering at a Premium to Market Price
https://finance.yahoo.com/news/redhill-biopharma-announces-1-25-110000118.html
TEL AVIV, Israel and RALEIGH, N.C., April 2, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into definitive agreements with private investors for the purchase and sale, at a premium, of 2,144,487 of the Company's American Depositary Shares ("ADSs"), each ADS representing four hundred (400) ordinary shares, par value NIS 0.01 per share, of the Company, and warrants to purchase up to an aggregate of 2,144,487ADSs, at a purchase price of $0.58289 per ADS and accompanying warrant, in a registered direct offering. The price per ADS and accompanying warrant represents a premium of 10% over $0.5299, the closing price of the ADSs as reported by the Nasdaq Capital Market on March 28, 2024. The warrants will have an exercise price of $0.75 per ADS, will be immediately exercisable upon issuance and have a term of five years following the issuance date. The closing of the offering is expected to occur on or about April 3, 2024, subject to the satisfaction of customary closing conditions.
No placement agent was used in connection with the offering.
The gross proceeds to the Company from the offering are expected to be $1.25 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes and working capital. The Company also announces that it plans to file its 2023 20-F on or about April 8, 2024.
Obviously sales of Aphexda is much
lower than planned or expected.
BioLineRx Announces $6 Million Registered Direct Offering
https://finance.yahoo.com/news/biolinerx-announces-6-million-registered-130000305.html
TEL AVIV, Israel, April 1, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced that it has entered into definitive agreements with several institutional investors for the issuance and sale in a registered direct offering of 7,500,000 of the Company's American Depositary Shares (ADSs) and warrants to purchase up to an aggregate of 7,500,000 ADSs, at a combined purchase price of $0.80 per ADS and accompanying warrant. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The warrants will have an exercise price of $0.80 per ADS, will be exercisable at any time upon issuance and will expire five years from the date of issuance. The offering is expected to close on or about April 1, 2024, subject to the satisfaction of customary closing conditions.
The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants), before deducting the placement agent's fees and other offering expenses payable by the Company, are expected to be $6.0 million. BioLineRx intends to use the net proceeds from the offering to support the commercialization of APHEXDA® (motixafortide) with an indication in the U.S. for stem cell mobilization for autologous transplantation in patients with multiple myeloma, advance its pancreatic cancer clinical development program and other pipeline programs, and for general corporate purposes.
"We believe that today's equity transaction, when combined with the potential drawdown of an additional $20 million tranche from our existing debt facility at favorable interest rates, together with our existing cash, provides the Company with the financial resources to continue building our momentum with the APHEXDA launch and advancing key life cycle programs for long-term growth opportunities", said Philip Serlin, Chief Executive Officer of BioLineRx.
JonesTrading Institutional Services LLC is acting as the exclusive placement agent for the offering.
The offering is being made by the Company pursuant to its shelf registration statement on Form F-3 (File No. 333-276323) previously filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on January 5, 2024, and only by means of a prospectus and prospectus supplement. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov. Alternatively, copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by sending a request to: JonesTrading Institutional Services LLC, Attention: Equity Capital Markets, 325 Hudson Street New York, New York 10013; email: ecm@jonestrading.com.
Can-Fite BioPharma, Ltd. to Present at the LD Micro Invitational XIV
https://finance.yahoo.com/news/fite-biopharma-ltd-present-ld-110000897.html
Ramat Gan, Israel--(Newsfile Corp. - April 1, 2024) - Can-Fite BioPharma, Ltd. (NYSE American: CANF) announced today that it will be presenting at The 14th Annual LD Micro Invitational at the Sofitel New York on April 8th-9th, 2024. The event is expected to feature 80 companies presenting in half-hour increments, as well as private 1:1 meetings.
Can-Fite BioPharma, Ltd. is scheduled to present on April 9th at 4:30 PM ET. Motti Farbstein, CEO, will be leading the presentation.
We invite interested parties to register to watch the presentation virtually here.
Hebrew article - Google translated:
The Bioline report
Bioline, which is traded in Tel Aviv and NASDAQ, and which developed a product that improves the process of collecting stem cells as part of bone marrow transplant treatment, this week published its reports for 2023, the first year in which its drug Aphexda is on the market. The drug was approved for marketing in September, and the company recorded annual revenues of 4.8 million dollars, but of that only 0.2 million is from actual product sales and the rest is an advance from a licensing deal for the product in Asia. That is, in the last two months of 2023, the company still hasn't had time to significantly realize its marketing channels.
Investors were not satisfied with the pace of the launch and sent the stock down 17%, so the company's value now stands at $83 million. The announcement by Gamida Cell, another Israeli company in a similar field, that after a stuttering launch, it will be deleted from the stock market and become a private company may also have had an impact.
However, Bioline communicated in the report about progress in obtaining insurance indemnity for the product. Insurance companies that cover 95% of the relevant patients have agreed in principle to cover the use of the product, which is also included in the medical protocols of the organizations of doctors dealing with transplants. About 20% of the main transplant centers are already able to handle Bioline's procedure, and it hopes to report 35% of these by the end of the first half of 2024 and 60% by the end of 2024. The company also has additional products in development.
The company has about 43 million dollars in its coffers, which should be enough for it, along with a line of credit it received from Kreos Capital, to finance its planned activities until 2025.
Can-Fite Reports 2023 Financial Results and Clinical Update
https://finance.yahoo.com/news/fite-reports-2023-financial-results-110000839.html
Ewopharma acquired marketing rights for namodenoson in the treatment of pancreatic carcinoma
RAMAT GAN, Israel, March 28, 2024--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results and clinical updates for the twelve months ended December 31, 2023.
Recent Clinical & Development Milestones Achieved
Namodenoson Drug Candidate:
Ewopharma recently acquired marketing rights for Namodenoson in the treatment of pancreatic carcinoma
This adds up to an out licensing agreement that Can-Fite signed with Switzerland-based Ewopharma in 2021, for exclusive distribution of both Piclidenoson and Namodenoson in Central Eastern European (CEE) countries (Piclidenoson for the treatment of psoriasis and Namodenoson for the treatment of liver cancer and NASH). Under the terms of the distribution agreement, Ewopharma AG paid Can-Fite an upfront payment of US$2.25 million with up to an additional US$40.45 million, payable upon the achievement of regulatory and sales milestones, plus 17.5% royalties on net sales. Recently, Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.
Can-Fite Broadens its Strong Intellectual Property (IP) for NASH (MASH): Received Patent Allowance in Canada
Can-Fite received a Notice of Allowance from the Canadian Intellectual Property Office for its patent application titled "An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation". This invention addresses the use of Namodenoson for the reduction of liver fat in patients with NASH a clinical indication that is being developed by Can-Fite. In a successfully concluded Phase IIa study, Namodenoson, one of the Company’s two drugs in advanced clinical development, reduced liver fat content, showed anti-inflammatory effects manifested by a significant decrease in the liver enzymes ALT & AST, and decreased body weight in patients with NASH. A Company-sponsored study for Namodenoson for this indication is currently enrolling patients for a Phase IIb study which will include 140 patients, in whom liver pathology is the primary endpoint. Patent has already been issued in other major markets including the U.S., EU, Japan and China.
Piclidenoson Drug Candidate:
Positive Data from the COMFORT-1 Phase III Psoriasis Study Published in a Top Scientific Journal
The Journal of the European Academy of Dermatology and Venereology (EADV) published an article titled "Efficacy and safety of piclidenoson in plaque psoriasis: Results from a randomized phase 3 clinical trial (COMFORT-1)". EADV is a top ranked peer reviewed journal (impact factor 9.2) that publishes articles on clinical and basic science topics in dermatology. The article’s first author, Dr. K.A Papp, is an internationally renowned key opinion leader in the psoriasis field and was the engine for some registered drugs on the market for this devastating skin disease. The EADV article presents the safety and efficacy of Piclidenoson in the randomized, placebo- and active-controlled, double-blind Phase III COMFORT-1 trial. As previously reported, the study met its primary endpoint which was the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI-75) at Week 16 (3 mg BID dose: PASI 75 rate of 9.7% vs. 2.6% for Piclidenoson vs. placebo, p=0.037). Piclidenoson’s efficacy continued to increase throughout the study period in a linear manner with an excellent safety and tolerability profile. Currently, Piclidenoson is being evaluated in COMFORT-2 a pivotal Phase III study that has been approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
"Our advanced-stage pipeline continues to achieve milestones, with Piclidenoson and Namodenoson both positioned as potentially safe and effective treatments for the oncological diseases liver cancer & pancreatic carcinoma and the inflammatory and metabolic diseases psoriasis and NASH. We anticipate additional clinical progress and new out licensing deals in this year," stated Can-Fite CEO Motti Farbstein.
Financial Results
Revenues for the year ended December 31, 2023 were $0.74 million, a decrease of $0.07 million, or 8.6%, compared to $0.81 million for the year ended December 31, 2022. The decrease in revenues was mainly due to the recognition a lower portion of advance payments received under the Ewopharma distribution agreement entered in 2021 and a lower portion of advance payments received under distribution agreements from Gebro, Chong Kun Dung Pharmaceuticals, and Cipher Pharmaceuticals.
Research and development expenses for the year ended December 31, 2023 were $5.98 million, a decrease of $1.78 million, or 22.9%, compared to $7.76 million for the year ended December 31, 2022. Research and development expenses for the year ended December 31, 2023 comprised primarily of expenses associated with the completion of the Phase 3 study of Piclidenoson for the treatment of psoriasis and two ongoing studies for Namodenoson, a Phase 3 study in the treatment of advanced liver cancer and a Phase 2b study for NASH. The decrease is primarily due to a decrease in expenses associated with Piclidenosnon.
General and administrative expenses were $2.95 million for the year ended December 31, 2023 a decrease of $0.19 million, or 6.05%, compared to $3.14 million for the year ended December 31, 2022. The decrease is primarily due to the decrease in directors and officer’s insurance policy premium. We expect that general and administrative expenses will remain at the same level through 2024.
Financial income (expense), net for the year ended December 31, 2023 aggregated $0.56 million compared to financial expense, net of $(0.07) for the year ended December 31, 2022. The decrease in financial expense, net was mainly due to increase interest from deposits and reduction in expenses related to the revaluation of our short-term investment.
Net loss for the year ended December 31, 2023 was $7.63 million compared with a net loss of $10.17 million for the same period in 2022. The decrease in net loss for the year ended December 31, 2023 was primarily attributable to the decrease in research and development expenses and in general and administrative expenses.
As of December 31, 2023, Can-Fite had cash and cash equivalents and short term deposits of $8.90 million as compared to $7.98 million at December 31, 2022. The decrease in cash during the year ended December 31, 2023 is due to the ongoing operations of the Company which was offset by the Company’s financing during January 2023 and exercise of certain warrants during November 2023.
The Company's consolidated financial results for the year ended December 31, 2023 are presented in accordance with US GAAP Reporting Standards.
More detailed information can be found in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, a copy of which has been filed with the Securities and Exchange Commission (SEC). The Annual Report, which contains the Company’s audited consolidated financial statements, can be accessed on the SEC’s website at http://www.sec.gov/ as well as via the Company’s investor relations website at https://ir.canfite.com. The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Can-Fite Investor Relations at 26 Ben Gurion Street, Ramat Gan, 5257346, Israel or by phone at +972-3-9241114.
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
December 31,
2023
2022
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
4,278
$
2,978
Short term deposits
4,625
5,001
Prepaid expenses and other current assets
986
1,170
Short-term investment
19
8
Total current assets
9,908
9,157
NON-CURRENT ASSETS:
Operating lease right of use assets
52
84
Property, plant and equipment, net
29
42
Total non-current assets
81
126
Total assets
$
9,989
$
9,283
CONSOLIDATED BALANCE SHEETS
U.S dollars in thousands (except for share and per share data)
December 31,
2023
2022
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables
$
427
$
896
Current maturity of operating lease liability
27
48
Deferred revenues
622
783
Other accounts payable
944
775
Total current liabilities
2,020
2,502
NON-CURRENT LIABILITIES:
Long - term operating lease liability
13
14
Deferred revenues
1,713
2,295
Total long-term liabilities
1,726
2,309
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at December 31, 2023 and December 31, 2022; Issued and outstanding: 1,359,837,393 and 815,746,293 shares as of December 31, 2023 and December 31, 2022
-
-
Additional paid-in capital
163,597
154,192
Accumulated other comprehensive income
1,127
1,127
Accumulated deficit
(158,481
)
(150,847
)
Total shareholders’ equity
6,243
4,472
Total liabilities and shareholders’ equity
$
9,989
$
9,283
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S dollars in thousands (except for share and per share data)
Year ended December 31,
2023
2022
Revenues
$
743
$
810
Research and development expenses
(5,983
)
(7,763
)
General and administrative expenses
(2,955
)
(3,143
)
Operating loss
(8,195
)
(10,096
)
Total financial income (expense), net
561
(77)
Net loss
(7,634
)
(10,173
)
Basic and diluted net loss per share
(0.01
)
(0.01
)
Weighted average number of ordinary shares used in computing basic and diluted net loss per share
1,278,333,912
815,746,293
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment of steatotic liver disease (SLD), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.can-fite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are "forward looking statements". Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the "Risk Factors" section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240328586605/en/
Contacts
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
Thomson Reuters StreetEvents
Q4 2023 Gamida Cell Ltd Earnings Call
Thu, March 28, 2024 at 5:19 AM GMT+2
In this article:
GMDA
-82.74%
Q4 2023 Gamida Cell Ltd Earnings Call
Participants
Mike Kuczkowski; Corporate Communications; Gamida Cell Ltd
Abigail Jenkins; President, Chief Executive Officer, Director; Gamida Cell Ltd
Terry Coelho; Chief Financial Officer; Gamida Cell Ltd
Presentation
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Gamida Cell's conference call for a business update and fourth quarter and full year 2023 financial results. My name is Daryl, and I'll be your operator for today's call. Please be advised that this call is being recorded at Gamida Cell's request. Now I would like to introduce you to our conference host, Mike Kuczkowski of Gamida Cell Corporate Communications. Mike, please go ahead.
Mike Kuczkowski
Thank you, Daryl, and good morning, everyone. Welcome to today's call, during which we will provide an update on the company and review our financial results for the fourth quarter and full year 2023. Earlier this morning, we issued two press releases. One announcing the commencement of a restructuring process supported by Highbridge Capital Management, and the other summarizing our financial results and providing a business update. Both press releases are available at our website, www.gamida-cell.com. Please note, we will not be hosting a question-and-answer session on today's call. Here with me on our call today are Abbey Jenkins, Gamida Cell's President and Chief Executive Officer; and Terry Coelho, our Chief Financial Officer.
Before we begin, I want to remind everyone that during this call, we may make forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any statement describing Gamida Cells goals, expectations, financial, or other projections, intentions, or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements, including those with respect to the curative, therapeutic, and commercial potential of Omisirge, omidubicel-onlv, Gamida Cell's cell therapy candidate, GDA-201, the continued commercialization of and patient access to Omisirge, the financial runway of Gamida Cell, Gamida Cell's ability to complete a transaction supported by Highbridge pursuant to the restructuring support agreement, Gamida Cell's ability to secure the Israeli court's approval of the transaction, Gamida Cell's expectations regarding the delisting from NASDAQ and the timing of the completion of the restructuring proceedings, and the state of Gamida Cell's workforce are subject to a number of risks, uncertainties, and assumptions.
These risks, uncertainties, and assumptions include those relating to clinical, scientific, regulatory, and technical developments and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and that's through the pursuit of the transactions contemplated under the RSA, the risk that no transaction may result.
In light of these risks and uncertainties and other risks and uncertainties that are described in the risk factors section and other sections of Gamida Cell's annual report on Form 10-K to be filed with the Securities and Exchange Commission on March 27, 2024 and other filings that Gamida Cell makes with the SEC from time to time, which are available at www.sec.gov. The events and circumstances discussed in such forward-looking statements may not occur and Gamida Cell's actual results could differ materially and adversely from those anticipated or implied, thereby. Although Gamida Cell's forward-looking statements reflect the good-faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you're cautioned not to rely on these forward looking statements.
Now, I will turn the call over to Gamida Cell's President and CEO, Abbey Jenkins.
Abigail Jenkins
Thank you, Mike, and everyone joining us today. In this past year, Gamida Cell has achieved important milestones, most notably our long-standing goal of bringing Omisirge to the FDA approval process as the only stem cell therapy approved on the basis of a global randomized Phase 3 clinical trial. As you will hear on today's call, patients continue to receive Omisirge as we onboard more transplant centers. We are gratified that Omisirge is available as a potentially life-saving option for patients with hematologic malignancies in need of a stem cell transplant. For these patients, Omisirge may represent their last, or best, cure, and we are proud to be able to continue to serve our patients.
We have also had to overcome many challenges in this process, including achieving long-term financial stability for the company. Today, I'm providing a corporate update and outlining the progress we've made to stabilize Gamida Cell's financial foundation. As you know, in Q2 2023, we initiated a strategic restructuring and engaged in an extensive process to pursue strategic alternatives to support the commercialization of Omisirge. Our initial strategic alternatives review process, included outreach to numerous potential strategic partners, including large and midsized pharmaceutical companies and we engaged in substantial discussions with many of those parties. Despite this effort, we did not identify a partnership that would adequately address our strategic needs by the end of the year.
In January, we redoubled our efforts and announced that we were focused on reaching a transaction that would provide the long term financial runway necessary for Gamida Cell to commercialize Omisirge, specifically pursuing a merger acquisition or asset sale. Through that process, we engaged with a number of parties, some as reengagement and others new. However, these efforts did not yield any actionable alternatives.
Earlier today, we announced that we have entered into a restructuring support agreement with Highbridge Capital Management, our principal lender. Under the terms of the agreement and upon completion of our restructuring process, Highbridge will convert $75 million of its existing unsecured convertible senior note into all of the equity in the company. The Company will receive $30 million of new capital from Highbridge on the effective date of the restructuring. Highbridge is also expected to invest significant additional capital following the company's emergence. Gamida Cellwill become a private company, wholly owned by Highbridge and the company's outstanding ordinary shares will be canceled. Current ordinary shareholders of Gamida Cell are expected to receive a contingent value right with a potential aggregate maximum value of $27.5 million, subject to the achievement of certain revenue and regulatory milestone within specified timeframe.
This restructuring transaction will enable Gamida Cell to remain a going concern and will support our ongoing efforts to make Omisirge available to more transplant centers and their patients. Gamida Cell's Board of Directors has determined that this transaction is the best path forward at this time to maintain patient access to Omisirge.
As a next step, Gamida Cell will begin a voluntary Israeli restructuring proceeding. We expect the transaction will close in the second quarter of 2024, following approval by the Israeli court. Once it closes, Gamida Cell will become a privately held company, fully owned by Highbridge, and will be de-listed from the NASDAQ. In parallel, we will be implementing a headcount reduction of approximately 25% of our team, to rightsize operations to align with the current business conditions and our focus on Omisirge commercialization. Also, Gamida Cell is finalizing the wind down of its Jerusalem office and consolidating all Israeli operations into our state-of-the-art manufacturing facility in Kiryat Gat.
Two key executives will be moving on from the company, Chief Commercial and Operating Officer, Michele Korfin, will depart the company on April 1; and General Counsel and Chief Compliance Officer, Josh Patterson, will depart the company on April 26. I would like to thank Michele and Josh for their years of dedication and service to Gamida Cell and their commitment to our patients. Their leadership and guidance have been instrumental in achieving the approval and commercialization of Omisirge, and we wish them well in their next endeavors.
In a similar way, I want to thank everyone on the team with whom we've had to make the difficult decision to part ways. These are extremely talented individuals who have been the driving force behind our ability to deliver unmanned modified cell therapy to patients. Even during challenging times in the biotech market, especially over this past year, I have witnessed this team's resilience. Faced with a delay of our date for Omisirge, the team rallied to deliver what was needed to secure approval in April. When it was eventually approved two weeks early, the team rallied again to ensure Omisirge was immediately available to transplant centers and patients.
In the face of the Israel-Hamas war, this team again showed courage and commitment, maintaining our operations without interruptions. Time and time again, this team has put patients first, and I could not be prouder of what we have accomplished. For those moving on, I have no doubt they will continue to bring positive change for patients in their future endeavors, and we will do whatever we can to support their transitions to new positions in the industry. Any company would be lucky to have these talented individuals as part of their team.
Shifting gears for a few minutes into commercial and medical updates. I would like to walk through where we ended the year against our 2023 goal. We onboarded a total of 17 transplant centers, exceeding the top end of the goal of 10 to 15 for the year. Omisirge has confirmed coverage with US payers covering more than 90% of commercial lives, exceeding our full-year goal of 70%. This includes covered -- confirmed coverage with all of the top 20 US commercial payers. Omisirge also has confirmed Medicare coverage and reimbursement. We reported revenue from the delivery of six units of Omisirge in 2023, including four units in the fourth quarter, meeting our goal of delivering a total of four to six units of Omisirge for the year. As of today, three units of Omisirge have been delivered this year, and we have a total of 24 transplant centers onboarded where patients can access Omisirge.
In addition, today, we announced the results from 13 patients in our Phase 1 dose escalation clinical trial of GDA-201. There were no dose-limiting toxicities and no GDA-201 related grade three or four adverse events. Efficacy evaluation showed three patients with complete response, two with partial response, and two with stable disease. You can see the details of these results in our press release. These data offer positive signals about the potential anti-tumor activity for GDA-201. Gamida Cell does not plan to conduct further development of GDA-201 at this time.
Going forward, our executive team, including myself; Terry Coelho, who has agreed to continue as Chief Financial Officer through June 2024; Ronit Simantov, our Chief Medical and Scientific Officer; and Penny Bushell, our Chief Human Resources Officer, will continue to manage the business, focused on supporting the continued uptake of Omisirge with transplant centers and patients.
I will now turn the call over to Terry to provide a financial update and additional details about our restructuring process. Terry, over to you.
Terry Coelho
Thank you, Abbey, and good morning, everyone. I will begin by sharing more information about the restructuring process supported by Highbridge Capital Management that we announced earlier today. Through this process, Highbridge will convert all $75 million of existing unsecured convertible senior notes into equity, which will represent 100% of the outstanding equity in the newly reorganized company. This transaction will reduce Gamida Cell's outstanding debt by $75 million and annual interest expense by $4.4 million. The company will receive a secured debt facility of $50 million, of which approximately $5 million will be the remaining principal amount due on Gamida Cell's existing secured convertible senior notes.
Now turning to results. 2023 represented our first year as revenue generating company. As Abbey mentioned, we reported revenue from the delivery of six units of Omisirge in 2023, including four units in the fourth quarter, meeting our goal for the year. As we shift from a clinical stage company to a commercial stage company, certain reclassifications of spend were incorporated into our financial reporting beginning in the third quarter of 2023. I will point out the key changes as we walk through the financial results.
In the fourth quarter ended December 31, 2023, we are reporting net revenue of $1.1 million, resulting from the delivery of the four units of Omisirge. Full year 2023 net revenue was $1.8 million, resulting from the delivery of six units of Omisirge. Full year 2023 cost of sales, including cost of direct manufacturing and quality in addition to royalty expenses and that shows your costs where applicable was $1.5 million for full year 2023, resulting in 18.5% gross margin for the year. Overtime, we expect the cost of sales and therefore the gross margin improved measurably as production volumes scale to capacity.
Beginning July 1, 2023, the reporting of operating expenses has been modified to reflect the company's transition to commercial stage, with all operating expenses being reported as either research and development expenses, excess capacity, or selling, general, and administrative or SG&A expenses. For 2022, and the first two quarters of 2023, previously reported commercial and general and administrative costs were combined into SG&A expenses. Additionally, certain expenses previously recorded in research and development are now being reported in SG&A beginning in the third quarter of 2023, with no reclassification of prior periods.
Research and development expenses were $24.3 million for the 12 months ended December 31, 2023, compared to $42.7 million in 2022. The decrease of $18.4 million was due primarily to the aforementioned reporting transition, along with reduced omidubicel clinical spend relating to the winding down of the Phase 3 clinical trial and reduced NK platform clinical and research and development spend. Excess capacity costs were $4.1 million in 2023, reflecting costs associated with labor, manufacturing, overheads, and manufacturing depreciation above our standard cost of goods, which are based on staffed capacity levels.
SG&A expenses were $44.6 million in 2023, an increase of $12.3 million compared to 2022. The aforementioned financial reporting transition, which resulted in the inclusion of medical affairs, expenses, and certain indirect supply chain and quality assurance expenses in SG&A reporting, contributed approximately $6.9 million to the increase in 2023 as compared to 2022. Selling and marketing expenses increased by $4.3 million compared to the prior year due to commercial launch activities. General and administrative expenses increased by approximately $1.1 million in 2023 as compared to 2022.
Financial income or expenses net were $10 million of income in 2023 compared to $4.4 million of expense in 2022. The $14.4 million change in financial income was primarily due to $17.5 million of non-cash income related to the valuation of warrants liability, partially offset by $1.9 million of higher interest expenses, $600,000 of non-cash loss related to the valuation of the company's secured convertible senior notes issued in December 2022, and $0.5 million of lower interest income.
Our net loss was $63 million in 2023 compared to a net loss of $79.4 million in 2022, with the lower net loss being driven primarily by the increase in financial income of $14.4 million, together with approximately $2 million of lower operating expenses. In the fourth quarter of 2023, our net loss was $8.8 million compared to a net loss of $22.8 million in the fourth quarter of 2022, primarily driven by the increase in financial income of $10 million, together with approximately $4 million of lower operating expenses.
As of December 31, 2023, Gamida Cell had total cash and cash equivalents of $46.6 million compared to $64.7 million as of December 31, 2022, to the decrease of $18.1 million is due primarily to $61.8 million in net cash proceeds from financing activities, which was comprised of $21.1 million in net proceeds from the issuance of ordinary shares and warrants from the company's underwritten public offering in April 2023 and $43.1 million in net proceeds from the issuance of ordinary shares via the at the market or ATM facility, offset by $2.2 million in principal payments of the company's 2022 convertible senior note and $79.1 million of net cash used in operating activities.
As of March 15, 2024, for our preliminary estimated unrestricted cash and cash equivalents balance was $28.5 million. Although it is difficult to predict future liquidity requirements, we believe that our current total existing funds will not be sufficient to support our ongoing operating activities, including the restructuring process through the end of the second quarter of 2024.
Finally, with regard to our debt position, as of December 31, 2023, the company had reduced its principal balance on the 2022 secured convertible note by $18.4 million from $25 million as of December 31, 2022, $6.6 million at the end of the fourth quarter of 2023. The company also holds a 2021 convertible senior note with an aggregate principal amount of $75 million.
With that, I will turn the call back over to Abbey for some concluding remarks. Abbey?
Abigail Jenkins
Thank you, Terry. Today, we discussed several important business updates, most notably, the decision to enter into a restructuring support agreement with Highbridge Capital. The transaction allows Gamida Cell to continue as a going concern and to focus on commercializing Omisirge as we develop and deepen our relationships with transplant center partners to increase access to Omisirge. Going forward, we will be a leaner, more focused organization and with a more stable financial foundation. Gamida Cell will be positioned to continue delivering this potentially life-saving cell therapy for patients with hematologic malignancies, including those from diverse backgrounds.
I want to once again thank our employees and express our gratitude to our transplant center partners and vendors for their support through this time of uncertainty as we continue to advance the commercialization of Omisirge. We continue to believe in the future of Gamida Cell and are grateful that Omisirge is available for the patients that need it most.
Thank you, everyone, for joining us on the call today. Operator, back to you.
Operator
Thank you. That does conclude today's teleconference. We appreciate your participation. You may disconnect at this time. Enjoy the rest of your day.
BioLineRx Ltd. (NASDAQ:BLRX) Q4 2023 Earnings Call Transcript March 26, 2024
Operator: Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Fourth Quarter and Full Year 2023 Financial Results Conference Call. All participants are presently in a listen-only mode. Following management’s formal presentation, instructions will be given for the question-and-answer session. I would now like to turn the call over to John Lacey, Head of Investor Relations and Corporate Communications. John, please go ahead.
John Lacey: Thank you, Operator. Welcome, everyone. Thank you for joining us on our fourth quarter and full year 2023 results conference call. Earlier today, we issued a press release, a copy of which is available in the Investor Relations section of our website. It was also filed as a 6-K. I'd like to remind you that certain statements we make during the call will be forward-looking. If have such statements due to future events and are subject to many risks and uncertainty, actual results may differ materially from those in the forward-looking statements. For a full discussion of these risks and uncertainties, please review our annual report on Form 20-F and our quarterly report on Form 6-K that are filed with the U.S. Securities and Exchange Commission. At this time, it is now my pleasure to turn the call over to Mr. Phil Serlin, Chief Executive Officer of BioLineRx.
Phil Serlin: Thank you, John, and good morning, everyone, and thank you for joining us on today's call. Joining me today are Holly May, President of BioLineRx USA; and Mali Zeevi, our Chief Financial Officer. In addition, Ella Sorani, our Chief Development Officer, will be joining the call for Q&A. I will begin with a brief update on our APHEXDA launch then turn the call over to Holly who will go into the Stem Cell Mobilization opportunity in more detail. I will then provide an update on our clinical programs in pancreatic cancer and sickle cell disease. Finally, Mali will provide a discussion of our financial results. We will then open up the call and are looking forward to your questions. Following the launch of our product in stem cell mobilization just a few months ago in Q4, we expect substantially all of 2024 to continue to be a foundational period for the commercialization of APHEXDA, the first advancement in stem cell mobilization in over a decade.
Since FDA approval in September and the subsequent launch of APHEXDA in U.S. in Q4 early signs among payers and top tier stem cell transplant centers suggest that the APHEXDA value proposition is resonating very well and evolving the stem cell mobilization treatment paradigm for patients with multiple myeloma. Recall that a key consideration when we elected to commercialize APHEXDA independently in the U.S. was that end users of APHEXDA transplant centers are well defined with approximately 80 of 212 transplant centers performing the vast majority approximately 85% of all procedures. Among this defined population, we have already secured formulary placement within these top 80 transplant centers managing approximately 20% of all stem cell transplant procedures at these institutions.
Those familiar with commercial launches know that institutional pharmacy and therapeutic committees or P&Ts determine formulary status, the first step in center adoption and we anticipate that by year-end we will have secured formulary placement within these top 80 transplant centers managing approximately 60% of all stem cell transplant procedures at these institutions. We are pleased with this progress and momentum which is right in line with our expectations. Our customer facing teams have done a fantastic job working with centers to support them in developing protocols following P&T approvals and we are very pleased by the number of clinical champions we are gaining every day. We have also received several repeat orders from multiple institutions.
These centers were early adopters and moved quickly through the formulary process and subsequent design and adoption of new treatment protocols. Importantly, one highly regarded transplant center has already transitioned to all of its patients to APHEXDA, as it recognizes the value of greater apheresis certainty. We are pleased by this early momentum despite the fact that some customers have benefited from lower acquisition costs for generic mozobil or plerixafor relative to reimbursement rates. This cost recovery advantage has been diminishing with time as reimbursement rates adjust to having generic plerixafor in the landscape. Meanwhile, transplantation centers are gaining the opportunity to experience the value APHEXDA can bring to their centers that extend beyond drug cost, including the overall economic benefit of reducing apheresis days and the predictability regarding the number of apheresis days and the impact this reduction has on patients as well as nursing and technical staffing for apheresis, particularly in today's difficult hiring environment and the competition for apheresis tier time.
Staying on the topic stem cell mobilization, recall that in October, we closed an exclusive license agreement with Gloria Biosciences for the development and commercialization of motixafortide across all indications in Asia. In order to receive market authorization for APHEXDA in China, a small bridging study is required. I'm pleased to share that the IND for this bridging study was filed in February with the Center for Drug Evaluation of the National Medical Products Administration and we anticipate regulatory action in May. First patient dosed in this study is expected in the second half of this year. Additionally, for countries in Asia that do not require a bridging study, Gloria is making great progress. We anticipate commercialization to begin in the Bao region of China in Singapore and in Macau over the next few quarters.
We believe that commercialization in these territories will provide nine U.S. revenue in the second half of the year or early next year subject to regulatory approval. We estimate that Asia had over 51,000 reported cases of multiple myeloma to largest number of cases globally and stem cell mobilization for autologous transplantation represents a significant opportunity for both companies in the region. Needless to say, we are very pleased with how our Gloria collaboration is progressing. We are also pleased by the progress that we have made since our last quarterly update on our other motixafortide programs, notably, pancreatic cancer and sickle cell disease. I will provide updates on those programs in a moment. But at this point, I'd like to turn the call over to Holly May, President of BioLineRx U.S. for a more detailed review of our early launch progress.
Holly, please go ahead.
Holly May : Thank you, Phil. As Phil indicated, patients, physicians and transplant center teams have begun experiencing strong stem cell mobilization results with APHEXDA. We call this the A-plus A for apheresis experience. Importantly, each positive experience resonates within institutions already using APHEXDA and supports strong peer-to-peer conversations between physicians at other institutions. As Phil said earlier, last quarter and this full year is foundational for APHEXDA commercialization. The pathway to adoption of any new drug of this type is roughly the same. P&T committee scheduling and review, institutional protocol development and staff training, first patient scheduled and use, experience assessment, reorder.
This cycle will happen across our top 80 centers and is occurring at a pace that we anticipated. We have a very strong value proposition for patients, transplant centers and payers and it is resonating. Our goal is to significantly reduce patient and caregiver burden by providing increased assurance in individual apheresis journeys. Additionally, for transplant centers with significant apheresis volume, we can show the advantages that APHEXDA provides for scheduling and use of chair time. Remember that patients with multiple myeloma in the United States are now often treated with quadruplet induction therapy, which includes lenalidomide and bortezomib. Quad therapy leads to the highest rate of complete responses and prolonged progression free survival.
However, this combination is known to contribute to poor stem cell mobilization collection experiences, which leads to an increase in the amount of apheresis session needed to collect the targeted number of CD34+ positive stem cells stem cells required by institutional protocols. With treatment for multiple myeloma moving to quad therapy, we believe this further strengthens our value proposition. Our targeted field force which was hired based on their significant and relevant experience is educating transplant center and apheresis' leadership team on the benefits of APHEXDA. Physician reactions from our meetings at ASH 2023 and more recently at Tandem 2024 have demonstrated a strong belief in our clinical data. Our poster session at both congresses further bolstered our clinical story.
Since launch, we have successfully made in-person contact with all top tier centers. Overall, we estimate the top 80 transplant centers in the U.S. manage approximately 85% of all transplants annually. To date, we have been granted formulary approval by institutions which manage approximately 20% of all stem cell transplant procedures within these institutions. By the end of quarter two, we anticipate that this will increase to approximately 35% of transplant procedures at these top 80 centers. And as stated, by the end of the year, we anticipate formulary status in those managing 60% of the transplants in these centers. Now regarding the entrance of generic mozobil or plerixafor into the market. As we've said, while we consider plerixafor to be the same overall market basket as APHEXDA, we do not see the generic plerixafor as comparable to our drug.
APHEXDA is a second generation CXCR4 inhibitor and has a highly differentiated product profile based on stronger and more predictable mobilization outcome. Furthermore, our early discussions have showed a central to appreciate the innovation as they look to address their need for a better mobilizer. Turning now to payers. Payers view the APHEXDA clinical data very favorably and as a result, we have to date established access for 95% of covered lives across a mix of both commercial and government payers. We continue to work to increase this number so that APHEXDA is as broadly accessible to patients as possible. Additionally, the centers for Medicare and Medicaid services issued us a unique J-Code for APHEXDA, which is critical for obtaining timely reimbursement from all commercial and government payers.
Another way we provide reimbursement confidence is through BioLineRx Connect, our provider and patient services hub. Through this hub, providers can enroll patients to obtain assistance in benefits verification and prior authorization. If coverage issues arise, the hub can step in and help resolve issues. Additionally, payers can enroll their patients in the patient assistance program if they cannot afford the cost of APHEXDA. Those who qualify can receive drug at no cost. In summary, I'm very pleased with our launch progress to date. Our commercial and medical affairs teams are generating results in the early stages of this launch, as we continue to engage with top transplant centers, physician leaders and payers on this exciting new treatment option.
A pharmacist preparing a dose of an immuno-oncology agent for research use.
A pharmacist preparing a dose of an immuno-oncology agent for research use.
Now let me turn the call back over to Phil.
Phil Serlin : Thank you, Holly. Turning now to our second development indication for motixafortide pancreatic cancer. Remember that motixafortide has been shown to leverage the expression of CXCR4 on different immune cells and can increase the effectiveness of immune system treatments for solid tumors. CXCR4 is highly expressed in over 20 solid tumor types and correlates with poor patient prognosis. In studies with PD-1 inhibitors and chemotherapy in pancreatic cancer, PD-1 inhibitors, a major background of immune therapy today have shown almost no therapeutic advantage. However, in several preclinical studies and more importantly in an 80 patient Phase 2 study with two cohorts that we completed a few years ago, we demonstrated that motixafortide is synergistic with PD-1 inhibitors in the treatment of pancreatic cancer.
This Phase 2 study showed proof of mechanism of synergistic effect with PD-1 in multiple late stage treatment lines as well as promising efficacy when motixafortide is combined with both a PD-1 inhibitor and chemotherapy in second line pancreatic cancer patients. Based on this promising data, we entered into a Phase 2 study collaboration in first line pancreatic cancer sponsored by Columbia University and supported equally by BioLineRx and Regeneron. Recall that the trial known as Chemo for met panc originally had an initial pilot phase and based on the results of this pilot phase an assessment would be made on advancing to an expansion phase of the study. As we presented at the AACR Special Conference on Pancreatic Cancer last September, the data in the pilot phase of the study was quite compelling.
7 of 11 patients were 64% experienced a partial response of which five were confirmed PRs as of the July 2023 cutoff date, with one patient experiencing complete resolution of the metastatic lesion in the liver. Along with the three patients are 27% experiencing stable disease, this resulted in a disease control rate of 91%. These findings compare favorably to historic partial response and disease control rates of 23% and 48% respectively, reported with the current standard of care. Based on these compelling data, the collaboration partners in this study Columbia, Regeneron and BioLineRx agreed to amend the original expansion phase of the study from a single arm expansion study with a target enrollment of 30 patients to a much larger randomized Phase 2b study of a 108 patients with two arms.
Motixafortide, the PD-1 inhibitors, zimberelimab and standard of care chemotherapy versus standard of care chemotherapy alone. The trial's primary endpoint is progression free survival. Secondary objectives include safety, response rates, disease control rate, duration of clinical benefit and overall survival. And last month, we announced that the first patient was dosed in this randomized Phase 2b study. We believe the combination potential of motixafortide and PD-1 inhibitors in pancreatic cancer and other solid tumors could be a significant multibillion dollar opportunity and our work in pancreatic cancer, one of the most difficult to treat cancers is the starting point. Also in pancreatic cancer, a license agreement with Gloria Biosciences covers pancreatic cancer as well and we are working with them on the design of a randomized Phase 2b clinical trial evaluating motixafortide in combination with commercially approved PD-1 inhibitor, zimberelimab and standard of care combination chemotherapy in first line pancreatic cancer.
Zimberalimab is approved in the Asia region for relapsed or refractory classical Hodgkin's lymphoma and for recurrent or metastatic cervical cancer. Gloria Biosciences went from IND to commercialization of zimberalumab and its first indication in China within four years. So we believe they are uniquely positioned to explore the potential utility of motixafortide in combination trials against this difficult to treat cancer. Their Phase 2b trial in China is expected to commence in the first half of 2025. We are also evaluating motixafortide as a mobilization engines in autologous hematopoietic stem cell based gene therapy patients suffering from sickle cell disease, one of the most common generic diseases globally. Hematopoietic stem cell transplantation after genetic modification is potentially cured for patients with sickle cell disease.
However, significant quantities of hematopoietic stem cells are required for genetic manipulation and transplant success and the most commonly used drug for collection of stem cells G-CSF is contraindicated in patients with sickle cell disease. Therefore, peripheral blood mobilization of stem cells using plerixafor is the current strategy to collect hematopoietic stem cells for sickle cell disease gene therapies. As with multiple myeloma patients in many cases, the current mobilization treatment fails to reliably yield after the number of stem cell and sickle cell disease patients often require two to four mobilization cycles with each cycle including two or more apheresis sessions with a minimum 14-day washout period between each cycle to collect an adequate number, as such this patient population is very much in need of an effective new mobilization regimen.
To that end, last March, we announced a clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide in this indication. To gather with Wash U, we're conducting a proof-of-concept trial to study motixafortide as both a single agent and in combination with the immunomodulator, natalizumab. The study is evaluating the safety and tolerability of the two regimens as mobilization agents of CD34+ hematopoietic stem cells in patients with sickle cell disease as well as efficacy endpoints. Sickle cell disease is an important lifecycle strategy for APHEXDA and we are in discussions with multiple stakeholders to understand its potential usage in patients who may qualify for the two recently approved gene therapies in the United States.
We were very pleased to have the dose the first patient in this important trial in December and we anticipate data in the second half of this year. In summary, we are very excited by both our pancreatic cancer and sickle cell disease clinical development programs, which may provide incredible value to patients and shareholders. At this point, I'd now like to turn the call over to Mali, who will review our financials. Mali, please go ahead.
Mali Zeevi : Thank you, Phil. As is our practice in our financial discussion on this call, we will go over the most significant items in our financial statements; revenues, sales and marketing expenses, research and development expenses, non-operating expenses, net loss and cash. I invite you to review the filings we made this morning that contain our financials 20-F and press release for additional information. Total revenues for the year ended December 31, 2023 were $4.8 million compared to no revenues for the year ended December 31, 2022. Revenues in 2023, all of which were recorded in the fourth quarter primarily reflect a portion of the upfront payment from the Gloria Biosciences license agreement of which $4.6 million was recorded in 2023 as well as $0.2 million of revenues from product sales of APHEXDA in the U.S. Cost of revenues for the year ended December 31, 2023 amounted to $3.7 million compared to no cost of revenues for the year ended December 31, 2022.
The cost of revenues in 2023, all of which was recorded in the fourth quarter primarily reflect a $3 million sublicense fee to the upstream licensor of APHEXDA for payable on closing of the exclusive license agreement in Asia as well as amortization of an intangible asset in respect of this license revenues in the amount of $5 million. Cost of product sales were insignificant representing approximately 6% of related sales. Research and development expenses for the year ended December 31, 2023 were $12.5 million as compared to $17.6 million for the year ended December 31, 2022. The decrease resulted primarily from lower expenses related to motixafortide as NDA supporting activities as well as lower expenses associated with completion of the AGI-134.
Sales and marketing expenses for the year ended December 31, 2023 were $25.3 million as compared to $6.5 million for the year ended December 31, 2022. The increase resulted primarily from the ramp up of pre-commercialization and commercialization activities related to motixafortide. Non-operating expenses for the year ended December 31, 2023 were $10.8 million compared to non-operating income of $5.7 million for the year ended December 31, 2022. Non-operating expenses and income primarily relates to the non-cash revaluation of outstanding warrants resulting from changes in the company's share price during the respective periods. Net loss for the year ended December 31, 2023 was $60.6 million compared to $25 million for the year ended December 31, 2022.
The net loss for 2023 included $17.8 million of non-cash expenses specifically an expense of $11.1 million for the revaluation of warrant and a one-time $6.7 million impairment of intangible assets associated with discontinuation of the AGI-134 development program. The net loss for 2022 included $6.4 million of non-cash income, specifically related to the reevaluation of warrants. As of December 31, 2023, the company had cash, cash equivalents and short-term bank deposits of $43 million. The company anticipates that this amount and other available resources including amount available under a debt facility with Kreos Capital will be sufficient to fund operations as currently planned into 2025. And with that, I'll turn the call back over to Phil.
Phil Serlin : Thank you, Mali. In closing as is our custom, I would like to take a few moments to summarize our key upcoming milestones. First, continued commercial ramp up of APHEXDA in the U.S. Next, commercial expansion in Asia with collaboration partner Gloria Biosciences, then initiation of bridging study by Gloria Biosciences in 2024 to support approval of APHEXDA in stem cell mobilization for multiple myeloma in China. Next is completion of recruitment in the Phase 1 pilot study of motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease led by Washington University School of Medicine with initial data expected in the second half of this year. Next is continued recruitment in the chemo for med panc Phase 2 randomized clinical trial in first line metastatic pancreatic cancer sponsored by Columbia University.
And lastly, preparation activities with Gloria Biosciences on a randomized Phase 2 clinical trial evaluating motixafortide in combination with the PD-1 inhibitors in barilumab and standard of care chemotherapy in first line pancreatic cancer. With that, we have now concluded the formal part of our presentation. Operator, we will now open up the call to questions.
Operator: [Operator Instructions] The first question is from John Vandermosten of Zacks.
John Vandermosten: Just to get a little bit better understanding about how the formularies work and when APHEXDA’s added to the formulary, is it immediately replacing the third support and other alternative or is there it sounds like there’s some education that’s required to get students to on board with it. Is that correct?
Phil Serlin: John, so I just want to make sure I guess the line isn’t that clear. I want to make sure I understand. First of all, good morning. And, second, I think are you asking about the formulary process, how it works and how long the process takes? Is that — did I understand correctly?
John Vandermosten: Yes. And also, are the teams immediately picking up the use of APHEXDA or is there some education required to get them to get on board with it?
Phil Serlin: Holly, would you like to take that?
Holly May: Yes. That would be great. So you’re right. With this type of a product, formulary acceptance is critically important. It behaves while this is an outpatient product, it is sold in transplant centers associated with hospital institutions and therefore does require a P&T approval. So the way that it works is that I mean this is work and that’s exactly why we put the three field teams in place, sales, medical, as well as the payer team. And what required is, always having a clinical champion, an MD clinical champion, and then making sure that the message gets out to those who are associated with making the decision, and then you need to get on the schedule for formulary for the P&T committees. This can take several months.
And then once the decision is made, the formulary decision is made then protocols need to be in place, order sets then need to go in place. So that takes, some time. Some institutions have P&T meetings, monthly. Some are every other month. These are things that the field team knows and understands and we are working critically hard on getting on those formularies. So once on, yes, we have gotten several acceptances, and we are very happy to be selling APHEXDA in many institutions. It’s really very much up to the institution as to what those protocols look like and whether it’s kind of sole formulary or if it’s a shared formulary. I will say that we have had some institutions which have made the full switch over to APHEXDA for multiple myeloma.
But I do want to make sure that, I’ve answered your question clearly and that everyone understands that this cycle does take some time and therefore the uptake ramp for APHEXDA is exactly as we were expecting. It’s a little bit of a slower uptake than something such as like a retail product et cetera. Now does that answer the question?
John Vandermosten: Yes. That does. And then kind of continuing on from there, it sounds like there is somewhat of a standardized process to getting on the formulary, but is there a big level of difference in difficulty? I mean, maybe there’s a lot more hoops you have to jump through for some formularies rather than others? Is it pretty similar or somewhat harder?
Holly May: We have a saying that if you’ve seen one transplant center, you’ve seen one transplant center. So there are ranges of ease or difficulty by center. So it’s not that standard. Getting to know who the decision makers are is always the first challenge, and then being able to get to those individuals is important. You did ask a question that I — part of the question initially that I don’t think I answered. It is really, really important that there is either during and then after the formulary decision that education and in servicing, we call it in servicing with the institutions is in place so that, everyone knows how to dose the product, everybody knows how to administer and have best patient care. So it is definitely a process and it differs most certainly by institutions.
Some are quicker and some have a little bit more of a prolonged formulary process. So we, the field teams understand these differences and then they work center by center on what is required.
John Vandermosten: And second question is on the gene therapy opportunities. I think you suggested that the two approved sickle cell gene therapies, I think it’s Casgevy and Lyfgenia, are being used in the Washington University study. Have you been contacted by other gene therapies to possibly look at other uses of motixafortide in gene therapy processes?
Phil Serlin: So first of all, John, I think there might be a mistake. I don’t know or a misunderstanding because we are doing a Phase 1 trial for mobilization of sickle cell patients, at Wash-U, but these are not patients that are receiving any gene therapy, neither Vertex is nor Bluebirds at this point. So I just wanted to make sure that you understand that and if there was a misunderstanding, I apologize. So how — but we are I mean, I just, I can say that we are speaking with companies and with institutions, et cetera, et cetera. This is an area of real interest to us. I mean, we see this as a huge potential upside for the company. These patients require huge amounts of cells, 15 million to 20 million hematopoietic cells per kilogram and have very a lot of difficulty mobilizing, especially since they can’t get G-CSF.
So we think that we have a great product for them and we’re very much looking forward to getting the safety data and some initial efficacy data so that we can continue to make noise in this area and enter into other collaborations on the way towards being able to sell the product.
Holly May: Can I add on to that? I just want to be clear about the opportunity. This would be for ex-vivo type of approaches or those approaches — those gene therapy approaches which require CD34+ stem cells it would not be applicable for say a gene therapy, like an AAV gene therapy. So in looking at the gene therapy opportunities, our focus obviously would be on those that require stem cells in order to complete the gene therapy. That would be most definitely the focus as is with sickle cell as Phil just spoke of.
Phil Serlin: John, did that answer your question? Is there anything else?
John Vandermosten: No, I appreciate the answers, Phil. Thank you.
Operator: The next question is from Joe Pantginis of H. C. Wainwright.
Unidentified Analyst : This is [Lander] on for Joe. So regarding the Phase 2 study in pancreatic cancer in China with Gloria, I wonder if you could provide some color on the preparations. Do you anticipate any difficulties with the Chinese agency or recruitment or site activation of the trial? And also are there plans to expand to additional Asian territories besides Macau and Singapore?
Ella Sorani: Hi, this is Ella. With regards to the PDAC study in China — we are Gloria is planning to submit it to the regulatory authorities and hopefully the study can be initiated early by the end of this year or by the latest early next year that’s with regards to the PDAC. I think the question you asked of expanding in additional territories, you’re relating to the PDAC, was this related to PDAC or stem cell mobilization?
Unidentified Analyst : Maybe both. It’s Gloria. Are you planning on any agreement with Gloria to expand to additional territories beside China?
Phil Serlin: Yes. So maybe I can take that. So first of all, in PDAC, I also want to answer the second part of your question. We anticipate Gloria being able to recruit the patients quite quickly. As I mentioned in the prepared remarks, they were able to bring a drug in two indications for approval in China within four years, which is on Western terms very, very significant and very quick. And so I think their ability to recruit the patients for the Phase 2b study in PDAC is quite significant and some of the institutions there are quite large in comparison to institutions in the West. As far as where they’re going with the, for in other territories, I guess we can separate that into stem cell mobilization and PDAC. So with regard to stem cell mobilization, there are a number of territories because we have FDA approval, there are a number of territories in the Asia region, mostly in southeast Asia, like Singapore, some areas of China I think Macau, et cetera that have a sort of an early access type of program where you can use a drug, a U.S.-label drug based on FDA approval and sell into the territory to various hospitals, et cetera, et cetera.
And so they are working very diligently to try to start the commercialization very quickly in these smaller areas. But as far as the larger areas of the territory, for example, China, Japan and Korea, our assessment and their assessment as well is that there will probably be a bridging study, one or more bridging studies required that include Asian patients in order to get regulatory approval for stem cell mobilization. So that’s regarding stem cell mobilization. With regard to pancreatic cancer because pancreatic cancer has no approval anywhere, the pathway is obviously much longer. They’re still, they’re going to be starting the trial in China and I think that right now that’s sort of the main focus in pancreatic cancer is to get the trial up and initiated in China and see what the results are and then based on that expand perhaps into other areas.
We would be thinking as well about at some time down the road based on this data, interesting a partner, getting a partner interested in a large registrational Phase 2, 3 global trial but that’s a little bit down the road. But that’s sort of the pathway right now for Gloria in Asia. I hope that answers your question.
Operator: There are no further questions at this time. Before I ask Mr. Phil Serlin to go ahead with his closing statement, I would like to remind participants that a replay of this call is scheduled to begin two hours after the conference. In the U.S., please call 1-888-295-2634. In Israel, please call 039-255-0904. Internationally, please call 9723-9255-904. Mr. Serlin, would you like to make your concluding statement?
Phil Serlin : Yes. Thank you, operator. In closing, we are progressing through 2024 with significant momentum both with our ongoing commercial ramp of APHEXDA as well as the advancement of our development programs in pancreatic cancer and sickle cell disease. I am excited for what we are poised to accomplish over the remainder of year and next. Thank you all very much for your continued interest in BioLineRx. We look forward to providing you our next comprehensive quarterly May. Be safe, and have a great day.
Operator: Thank you. This concludes the BioLineRx fourth quarter 2023 conference call. Thank you for your participation. You may go ahead and disconnect.
The company will be removed from the listing,
shareholders will probably receive a few pennies
per share at best.
You answered your question.
Only if you have throw-away monies.
Methinks you got the bottom point, seems
to me it should only go up.
Announcing the death of my dream.
The SEC allows extra time for reporting end-of-fiscal-year financials, I consider it shareholder-unfriendly to release financials that are essentially a full quarter out of date.
Barring some accounting issue that requires restatement of prior results, even small companies should be able to close the books and get them audited in a timely manner.
From #msg-174095674
Note: Different company, perhaps differnent circumstances, exceprt brought herewith
as a possible would be RDHL excuse.
1.0200-0.2800 (-21.5385%)
As of 02:45PM EDT. Market open.
Volume 1,445,755
Avg. Volume 296,268
This i did not expect!!!
BioLineRx Reports 2023 Financial Results and Recent Corporate and Portfolio Updates
https://finance.yahoo.com/news/biolinerx-reports-2023-financial-results-110000704.html
- Reported significant commercial progress for APHEXDA® -- secured payer coverage representing ~95% of covered lives in the U.S.; continued progress on formulary approvals at targeted major transplant centers; received Healthcare Common Procedure Coding System (HCPCS) J-Code to facilitate Medicare reimbursement -
- Announced first patient dosed in randomized Phase 2b clinical trial evaluating motixafortide in first-line pancreatic cancer -
- Continued to support partner Gloria Biosciences in plans to execute pivotal bridging study of motixafortide in stem cell mobilization and Phase 2b randomized study in first-line pancreatic cancer in China -
- Management to host conference call today, March 26, at 8:30 am EDT -
TEL AVIV, Israel, March 26, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its financial results for the year ended December 31, 2023, and provided recent corporate and portfolio updates.
"Following FDA approval of APHEXDA® in September, physicians and transplant centers have been very receptive to the value of our strong clinical data, and our commercial team has made substantial progress establishing relationships with transplant centers across the country," said Philip Serlin, Chief Executive Officer of BioLineRx. "This year will continue to be primarily a foundational period for the commercialization of APHEXDA. We are seeing substantial progress on Pharmacy & Therapeutics committee approvals -- the first step toward center adoption -- and are actively supporting centers as they build usage protocols and treat their first patients. Initial feedback on patient experiences has been positive, and we are already seeing repeat purchases. Notably, we have achieved payer coverage representing approximately 95% of covered lives in the U.S. to date, which we believe reflects the value that APHEXDA offers to payers and patients alike, particularly its ability to mobilize the targeted number of stem cells in fewer apheresis sessions.
"Additionally, through a clinical collaboration with Washington University, we are actively evaluating the potential of motixafortide to support gene therapy for patients with sickle cell disease, a treatment process that requires significant quantities of hematopoietic stem cells. We anticipate data from this proof-of-concept Phase 1 study in patients with sickle cell disease in the second half of this year.
"At the same time, we are making significant progress advancing clinical programs evaluating motixafortide in pancreatic cancer, which if ultimately approved in combination with PD-1 inhibitors, would serve a much larger patient population and provide confidence for expanding into additional solid tumors. In pancreatic cancer, our enthusiasm is bolstered by the compelling data presented last fall from the single-arm pilot phase of the Phase 2b trial sponsored by Columbia University. The first patient has now been dosed in the randomized Phase 2b portion of that study, and we are also working with Gloria Biosciences on the design and execution of a similar randomized Phase 2b combination trial of motixafortide and zimberelimab in pancreatic cancer in China.
"Our vision of bringing a best-in-class stem cell mobilization agent to market, as well as advancing development in pancreatic cancer and other solid tumor areas with major unmet needs, is being actively realized. We look forward to the exciting, continued execution progress that our commercial and development teams will make this year," Mr. Serlin concluded.
Corporate Updates
Launched APHEXDA (motixafortide) in the U.S.
Announced closing of exclusive license agreement that includes development and commercialization rights to motixafortide across all indications in the Asia region, as well as a strategic equity investment
Strengthened motixafortide intellectual property estate with notice of allowance for U.S. patent covering method of manufacturing motixafortide suitable for large scale production; the patent supplements existing Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as Orphan Drug market exclusivity for autologous stem cell mobilization in multiple myeloma patients in the U.S. following last year's FDA approval of APHEXDA
APHEXDA Launch Updates
Reported positive coverage decisions by payers representing ~95% of all covered lives in the U.S.
Received inclusion of APHEXDA in the National Comprehensive Cancer Network (NCCN) guidelines for Hematopoietic Cell Transplantation
Achieved "on formulary" status for APHEXDA within targeted top 80 transplantation centers (which perform 85% of all U.S. transplants) managing ~20% of stem cell transplant procedures at these institutions; anticipate similar on formulary status of ~35% at end of Q2 2024 and ~60% at year-end 2024
Received Healthcare Common Procedure Coding System (HCPCS) J-Code to facilitate Medicare reimbursement for APHEXDA to transplant centers treating Medicare beneficiaries
Clinical Portfolio Updates
Motixafortide (selective inhibitor of CXCR4 chemokine receptor)
Multiple Myeloma
Presented posters at both the American Society of Hematology (ASH) 65th Annual Meeting on December 10, 2023, and the 2024 Tandem Meetings on February 21-24, 2024. The posters reviewed combination premedication benefits in the Phase 3 GENESIS trial, extended PD effect of elevated CD34+ cells in peripheral blood, and a post-hoc subgroup analysis of impaired HSC mobilization patients that demonstrated a consistent benefit of motixafortide + G-CSF over placebo + G-CSF mobilization for all patients
Supported collaboration partner Gloria Biosciences with stem cell mobilization bridging study IND filing in February with the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate regulatory action in May 2024 and initiation of pivotal clinical trial in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)
Announced first patient dosed in a randomized, investigator-initiated Phase 2b clinical trial in collaboration with Columbia University assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer
Advanced plans with collaboration partner Gloria Biosciences on a Phase 2b randomized clinical trial in China assessing motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
Sickle Cell Disease (SCD) & Gene Therapy
Continued to enroll patients into a clinical trial in collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. Anticipate data in 2H 2024
Financial Results for Year Ended December 31, 2023
Total revenues for the year ended December 31, 2023, were $4.8 million, compared to no revenues for the year ended December 31, 2022. Revenues in 2023 (all of which were recorded in the fourth quarter) primarily reflect a portion of the upfront payment from the Gloria Biosciences license agreement, of which $4.6 million was recognized in 2023, as well as $0.2 million of revenues from product sales of APHEXDA in the U.S.
Cost of revenues for the year ended December 31, 2023, amounted to $3.7 million, compared to no cost of revenues for the year ended December 31, 2022. The cost of revenues in 2023 (all of which was recorded in the fourth quarter) primarily reflects a $3.0 million sub-license fee to the upstream licensor of motixafortide payable on closing of the exclusive license agreement in Asia, as well as amortization of an intangible asset in respect of these license revenues in the amount of $0.5 million. Cost of product sales were insignificant, representing approximately 6% of related sales.
Research and development expenses for the year ended December 31, 2023, were $12.5 million, compared to $17.6 million for the year ended December 31, 2022. The decrease resulted primarily from lower expenses related to motixafortide NDA supporting activities, as well as lower expenses associated with completion of the AGI-134 study
Sales and marketing expenses for the year ended December 31, 2023, were $25.3 million, compared to $6.5 million for the year ended December 31, 2022. The increase resulted primarily from the ramp-up of pre-commercialization and commercialization activities related to motixafortide
General and administrative expenses for the year ended December 31, 2023, were $6.3 million, compared to $5.1 million for the year ended December 31, 2022. The increase resulted primarily from an increase in payroll and related expenses associated with a small headcount increase during the 2022 period, as well as an increase in professional services and legal expenses
Non-operating expenses for the year ended December 31, 2023, were $10.8 million, compared to non-operating income of $5.7 million for the year ended December 31, 2022. Non-operating expenses and income primarily relate to the non-cash revaluation of outstanding warrants resulting from changes in the company's share price during the respective periods
Net loss for the year ended December 31, 2023 was $60.6 million, compared to $25.0 million for the year ended December 31, 2022. The net loss for 2023 included $17.8 million in non-cash expenses, specifically an expense of $11.1 million for the revaluation of warrants and a one-time $6.7 million impairment of intangible assets associated with discontinuation of the AGI-134 development program. The net loss for 2022 included $6.4 million in non-cash income specifically related to the revaluation of warrants.
As of December 31, 2023, the Company had cash, cash equivalents, and short-term bank deposits of $43.0 million. The Company anticipates that this amount and other available resources, including amounts available under a debt facility with Kreos Capital, will be sufficient to fund operations, as currently planned, into 2025
A copy of the Company's annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at https://ir.biolinerx.com.The Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at IR@BioLineRx.com.
Conference Call and Webcast Information
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 28, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
biolinerx Q4 2023 Earnings Preview
Mar. 25, 2024 1:31 PM ETBioLineRx Ltd. (BLRX) Stock
By: Vansh Agarwal, SA News Editor
biolinerx (NASDAQ:BLRX) is scheduled to announce Q4 earnings
results on Tuesday, March 26th, before market open.
The consensus EPS Estimate is -$0.22 (-633.3% Y/Y)
and the consensus Revenue Estimate is $0.17M.
FWIW
1.3100+0.1100 (+9.1667%)
As of 11:29AM EDT. Market open.
Volume 483,923
Avg. Volume 288,336
Perhaps good news expectations?
In @ $4.98
Gamida Cell to Report Fourth Quarter and Full-Year 2023 Financial Results
https://finance.yahoo.com/news/gamida-cell-report-fourth-quarter-120000352.html
BOSTON, March 22, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will release its financial results for the fourth quarter and full year ended December 31, 2023 and provide an update on the company on Wednesday, March 27, 2024.
Following the release, management will host a conference call and live webcast at 8:30 AM Eastern Time to discuss the financial results and provide a business update.
Conference Call Dial-In & Webcast Information:
Date/Time:
Wednesday, March 27, 2024 at 8:30 AM Eastern Time
Domestic:
1-877-425-9470
International:
1-201-389-0878
Conference ID:
13744446
Call me™:
Click here.
Webcast:
Click here.
A replay of the webcast will be available on the Company’s website. approximately two hours after the event, for approximately 30 days.
About Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. These include Omisirge® (omidubicel-onlv), an FDA-approved nicotinamide modified allogeneic hematopoietic progenitor cell therapy, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, X, Facebook or Instagram.
Omisirge® is a registered mark of Gamida Cell Inc. © 2024 Gamida Cell Inc. All Rights Reserved.
Investor Contacts:
Chuck Padala
LifeSci Advisors
chuck@lifesciadvisors.com
1-646-627-8390
Media Contact:
Dan Boyle
Orangefiery
media@orangefiery.com
1-818-209-1692
MediWound Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Company Update.
https://finance.yahoo.com/news/mediwound-reports-fourth-quarter-full-110000175.html
$19 million revenue in 2023; $24 million projected revenue in 2024
NexoBrid® commercially launched in U.S., Japan, India
Potential blockbuster EscharEx® to begin Phase III in the second half of 2024
$42 million cash runway through profitability
Conference call today, March 21 at 8:30am Eastern Time
YAVNE, Israel, March 21, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.
“2023 was an exceptional year for NexoBrid driven by new market launches, expanded indications, substantial new governmental grants, and increased global demand. Additionally, this lifesaving treatment was successfully battle-tested in real-life burn mass casualty incidents (BMCI) during the war in Israel. Furthermore, the full capacity of our new manufacturing facility in 2025 will enable us to meet the soaring demand of NexoBrid,” said Ofer Gonen, CEO of MediWound. “Recent clinical data further validates our pipeline product, EscharEx, demonstrating that it significantly outperformed SANTYL® in a head-to-head comparative analysis. The product has attracted research collaborations with industry leaders 3M, Mölnlycke and MIMEDX and the Phase III study is set to begin in the second half of 2024. We strongly believe in the exciting future ahead for MediWound.”
2023 Highlights and Recent Developments:
NexoBrid®
Expanded commercial availability to U.S., Japan, and India, leading to $19 million revenue in 2023, and a surge of orders for 2024, with $24 million projected revenue.
Construction of a new GMP-compliant state-of-the-art manufacturing facility is on track for mid-2024 completion. It is projected to achieve a 6-fold manufacturing capacity increase in 2025.
Commercial Activities:
Launched in the U.S. by Vericel Corp, with more than 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and more than 25 already approved. Furthermore, the Centers for Medicare & Medicaid Services (CMS) awarded NexoBrid a permanent J code and granted it transitional pass-through payment status, enhancing its accessibility and reimbursement potential.
Launched in Japan through Kaken Pharmaceuticals, and in India through Bharat Serums and Vaccines (BSV).
Expanded European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands, and Luxembourg.
Successfully fulfilled emergency demand in Israel to treat mass burn casualties resulting from the war, consuming all available non-U.S. inventory.
Government Funding:
Awarded $13.0 million R&D funding by U.S. Department of Defense (DoD) to develop and produce a new NexoBrid temperature stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army.
Awarded $10.1 million in additional funding from the Biomedical Advanced Research and Development Authority (BARDA) for emergency preparedness product replenishment and R&D activities.
Pediatric label expansion:
Gained European Commission approval for the removal of eschar in deep partial- and full-thickness thermal burns for all ages.
Supplemental BLA for pediatric indication accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.
EscharEx®
Aligned the Phase III study protocol with the European Medicine Agency (EMA) and the FDA, and expected to submit a final protocol in the first half of 2024. 216 patients will be treated globally across 40 sites with either EscharEx or a gel vehicle placebo, with an interim assessment to be performed once 67% of participants complete the study. Study initiation is expected in the second half of 2024.
Established research collaborations with 3M, Mölnlycke and MIMEDX to support the EscharEx Phase III clinical study.
Conducted head-to-head comparative analysis of EscharEx vs SANTYL®. Data from a Phase II randomized controlled study demonstrated significant superiority of EscharEx over SANTYL in multiple clinical outcome measures: incidence of complete debridement; median time to achieve complete debridement; incidence of achieving wound bed preparation (WBP); median time to achieve WBP; and time to wound closure. The data is scheduled for oral presentation in May 2024 at three leading annual congresses dedicated to advanced wound care: The Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).
MW005
Reported positive results of the Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data showed MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.
Fourth Quarter 2023 Financial Highlights
Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
Gross Profit: Gross profit in the fourth quarter 2023 was $0.7 million, representing 13.5% of the total revenue in the fourth quarter of 2023, compared to $8.2 million, representing 70.2% of total revenue in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel in the fourth quarter of 2022.
Expenditures:
Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022. This change is primarily attributed to the completion of EscharEx phase II study in 2022.
Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.
Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.
Net Loss: Net loss in the fourth quarter of 2023 was $1.7 million or $0.19 per share, compared to the net loss of $7.5 million, or $1.18 per share in the fourth quarter of 2022. The decrease is primarily attributed to a favorable adjustment from the revaluation of warrants.
Non-GAAP Adjusted EBITDA: Adjusted EBITDA in the fourth quarter of 2023 was a loss of $3.2 million, compared to a profit of $3.4 million in the fourth quarter of 2022.
Full Year 2023 Financial Highlights
Revenue: Revenue for the year ended December 31, 2023, was $18.7 million, compared to $26.5 million for the year ended December 31, 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
Gross Profit: Gross profit for the year ended December 31, 2023, was $3.6 million with a gross margin of 19.1%, compared to $13.2 million with a gross margin of 49.7% in the prior year period. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
Expenditures:
Research and development expenses for the year ended December 31, 2023, were $7.5 million compared to $10.2 million in the prior year.
Selling, general, and administrative expenses for the year ended December 31, 2023, were $11.6 million, compared to $10.6 million in the prior year.
Operating Results: Operating loss for the year ended December 31, 2023, was $15.3 million, compared to an $8.3 million loss in the year ended December 31, 2022.
Net Loss: Net loss in the year ended December 31, 2023 was $6.7 million or $0.75 per share, compared to the net loss of $19.6 million, or $3.93 per share for the year ended December 31, 2022.
Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2023 was a loss of $12.3 million, compared to a loss of $4.4 million for the year ended December 31, 2022.
Balance Sheet Highlights
As of December 31, 2023, the Company’s cash, restricted cash, and investments were $42.1 million, compared to $34.1 million reported on December 31, 2022. In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering. The company used $17.1 million to fund its activities. The existing cash and restricted cash, and investments will provide sufficient funds through profitability.
Conference Call
MediWound management will host a conference call for investors on Thursday, March 21, 2024, beginning at 8:30 a.m., Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website.
A replay of the call will be available on the Company’s website at www.mediwound.com.
Non-IFRS Financial Measures
To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company’s performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.
Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our senior management.
However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company’s operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of solutions that seek to improve existing standards of care. MediWound is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.
MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant potential advantages over the $360 million dominant product and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a Phase I/II study.
For more information visit www.mediwound.com and follow the Company on LinkedIn and X.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including EscharEx® and NexoBrid®. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; the approval of regulatory submission by the FDA, the European Medicines Agency or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
Contacts:
Hani Luxenburg
Daniel Ferry
Chief Financial Officer
Managing Director, LifeSci Advisors
MediWound Ltd.
617-430-7576
ir@mediwound.com
daniel@lifesciadvisors.com
Media Contact:
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com
929-588-2008
MediWound, Ltd.
Audited Condensed Consolidated Statements of Financial Position
U.S. dollars in thousands
Dec 31,
2023
2022
CURRENT ASSTS:
Cash and cash equivalents and short-term deposits
41,708
33,895
Trade and other receivable
5,141
9,982
Inventories
2,846
1,963
Total current assets
49,695
45,840
Non-current assets
Other receivables
673
364
Property, plant and equipment, net
9,228
2,366
Right of use assets, net
6,698
1,215
Intangible assets, net
165
231
Total non-current assets
16,764
4,176
Total assets
66,459
50,016
CURRENT LIABILITIES:
Current maturities of long-term liabilities
1,410
2,242
Trade payables and accrued expenses
5,528
5,656
Other payables
3,891
4,159
Total current liabilities
10,829
12,057
Warrants, net
7,296
15,606
Liabilities in respect of IIA grants
7,677
7,445
Liability in respect of TEVA
2,256
2,788
Lease liabilities
6,350
846
Severance pay liability, net
456
360
Total non-current liabilities
24,035
27,045
Shareholders' equity
31,595
10,914
Total liabilities & equity
66,459
50,016
MediWound, Ltd.
Audited Condensed Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss
U.S. dollars in thousands (except of share and per share data)
Twelve months ended
Three months ended
Dec 31,
Dec 31,
2023
2022
2023
2022
Total Revenues
18,686
26,496
5,338
11,618
Cost of revenues
15,108
13,331
4,619
3,460
Gross profit
3,578
13,165
719
8,158
Research and development
7,467
10,181
1,808
2,699
Selling and Marketing
4,844
3,725
1,209
692
General and administrative
6,768
6,920
1,583
2,269
Other (Income) expenses
(211)
684
13
375
Operating loss
(15,290)
(8,345)
(3,894)
2,123
Financial income (expenses), net
8,759
(11,176)
2,271
(9,515)
Taxes on income
(185)
(78)
(120)
(65)
Net loss
(6,716)
(19,599)
(1,743)
(7,457)
Foreign currency translation adjustments
(13)
14
(11)
(20)
Total comprehensive loss
(6,729)
(19,585)
(1,754)
(7,477)
Basic and diluted loss per share:
Net loss per share
(0.75)
(3.93)
(0.19)
(1.18)
Weighted average number of ordinary shares
9,013,144
4,987,069
9,219,923
6,332,981
MediWound, Ltd.
Audited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
Twelve months ended
Three months ended
Dec 31,
Dec 31,
2023
2022
2023
2022
Audited
Unaudited
Cash Flows from Operating Activities:
Net Loss
(6,716)
(19,599)
(1,743)
(7,457)
Adjustments to reconcile net loss to net cash used in operating activities:
Adjustments to profit and loss items:
Depreciation and amortization
1,303
1,272
346
284
Share-based compensation
1,940
1,946
298
642
Revaluation of warrants accounted at fair value
(8,310)
8,977
(1,603)
8,977
Issuance expenses of warrants through profit and loss
-
1,911
-
1,523
Revaluation of liabilities in respect of IIA grants
427
(132)
(282)
(944)
Revaluation of liabilities in respect of TEVA
468
533
111
129
Financing income and exchange differences of lease liability
257
(109)
463
37
Increase in severance liability, net
83
109
3
45
Other income
(211)
-
13
-
Financial income, net
(2,231)
(74)
(836)
(408)
Un-realized foreign currency loss (gain)
189
525
(347)
60
(6,085)
14,958
(1,834)
10,345
Changes in asset and liability items:
Decrease (increase) in trade receivables
5,658
(7,582)
(528)
(5,137)
Decrease (increase) in inventories
(906)
(721)
782
(113)
Decrease (increase) in other receivables
(894)
364
(696)
221
Increase (decrease) in trade payables and accrued expenses
(594)
414
1,093
784
Increase (decrease) in other payables
(928)
281
311
2,107
2,336
(7,244)
962
(2,138)
Net cash used in operating activities
(10,465)
(11,885)
(2,615)
750
MediWound, Ltd.
Audited Condensed Consolidated Statements of Cash Flows
U.S. dollars in thousands
Cash Flows from Investing Activities:
Purchase of property and equipment
(6,464)
(555)
(2,209)
(174)
Interest received
1,947
74
722
71
Proceeds from (Investment in) short term bank deposits, net
(29,804)
-
6,515
2,499
Net cash used in investing activities
(34,321)
(481)
5,028
2,396
Cash Flows from Financing Activities:
Repayment of lease liabilities
(778)
(701)
(204)
(170)
Proceeds from issuance of shares and warrants, net
24,909
38,390
-
16,475
Repayments of IIA grants, net
(380)
(258)
-
-
Repayment of liabilities in respect of TEVA
(834)
(1,667)
-
(417)
Net cash provided by (used in) financing activities
22,917
35,764
(204)
15,588
Exchange rate differences on cash and cash equivalent balances
(160)
(549)
378
(44)
Increase (decrease) in cash and cash equivalents
(22,029)
22,849
2,587
18,990
Balance of cash and cash equivalents at the beginning of the period
33,895
11,046
9,279
14,905
Balance of cash and cash equivalents at the end of the period
11,866
33,895
11,866
33,895
MediWound, Ltd.
Adjusted EBITDA
U.S. dollars in thousands
Twelve months ended
Three months ended
Dec 31,
Dec 31,
2023
2022
2023
2022
Net loss
(6,716)
(19,599)
(1,743)
(7,457)
Adjustments:
Financial income (expenses), net
8,759
(11,176)
2,271
(9,515)
Other (Income) expenses, net
211
(684)
(13)
(375)
Taxes on income
(185)
(78)
(120)
(65)
Depreciation and amortization
(1,303)
(1,272)
(346)
(284)
Share-based compensation expenses
(1,940)
(1,946)
(298)
(642)
Total adjustments
5,542
(15,156)
1,494
(10,881)
Adjusted EBITDA
(12,258)
(4,443)
(3,237)
3,424
Evogene Reports Receipt of Nasdaq Minimum Bid Price Notification
https://finance.yahoo.com/news/evogene-reports-receipt-nasdaq-minimum-130000131.html
REHOVOT, Israel, March 20, 2024 /PRNewswire/ -- Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN) (the "Company", "Evogene"), a leading computational biology company targeting to revolutionize life-science product discovery and development across multiple market segments, today reported that the Company received a letter (the "Letter") from the Nasdaq Stock Market LLC ("Nasdaq"), indicating that the Company is currently not in compliance with Nasdaq Rule 5550(a)(2), as the Company's closing bid price for its ordinary shares has been below $1.00 per share for the last 30 consecutive business days.
If the Company does not demonstrate compliance (with the bid price requirement or with any other listing requirements) prior to the end of the 180-day period ending September 16, 2024, the Nasdaq's staff will notify the Company that its ordinary shares will be subject to delisting.
It is noted that Evogene's continued listing on Nasdaq remains a key priority for the Company. Should the situation not resolve itself over the above-mentioned timeframe, the Company intends to consider other available options to cure the deficiency and regain compliance with the minimum bid requirement within the compliance period, including potentially approving a reverse share split among other alternatives.
The Letter from Nasdaq has no immediate effect on the Company's Nasdaq listing or the trading of its ordinary shares on Nasdaq, and during the aforementioned cure period, the Company's ordinary shares will continue to trade on the Nasdaq Capital Market under the symbol "EVGN". It is further noted that the Letter from Nasdaq has no bearing on Evogene's listing on the Tel Aviv Stock Exchange, where its ordinary shares are traded under the ticker symbol "EVGN".
BioLineRx to Report 2023 Annual Financial Results on March 26, 2024
https://finance.yahoo.com/news/biolinerx-report-2023-annual-financial-110000667.html
TEL AVIV, Israel, March 20, 2024 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today announced it will release its audited financial results for the year ended December 31, 2023 on Tuesday, March 26, 2024, before the U.S. markets open.
The Company will host a conference call at 08:30 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.
To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 28, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.
Bayer AG and Lavie Bio Continue for Second Year of Biofungicides Validation Following Successful Lab and Greenhouse Testing
https://finance.yahoo.com/news/bayer-ag-lavie-bio-continue-130000956.html
REHOVOT, Israel, March 19, 2024 /PRNewswire/ -- Lavie Bio Ltd., a leading ag-biologicals company that develops microbiome-based, computational-driven bio-stimulant and bio-pesticide novel products and a subsidiary of Evogene Ltd. (Nasdaq: EVGN) (TASE: EVGN), announced today that it is extending its joint validation trials for its biofungicides conducted by Bayer AG, a global leader in the agriculture industry, after successful first-year laboratory and greenhouse testing. The tests have demonstrated the efficacy of Lavie Bio's biofungicides in addressing devastating diseases that affect fruits and vegetables worldwide. Building on these positive outcomes, the companies are progressing to a second year of validation trials in field experiments.
"This is an important step in our open innovation strategy to bring new biological solutions to growers," said Benoit Hartmann, Head of Biologics at Bayer Crop Science. "Biofungicides are a real opportunity for innovation, and we are looking forward to the new solutions this partnership with Lavie Bio helps us deliver together."
"We are delighted with the consistently positive results we have observed in our experiments, which has led to the decision to extend the validation trials for another year in the field," said Amit Noam, CEO of Lavie Bio. "This not only highlights the immense business potential of our product and its meaningful impact on farmers worldwide but also reinforces our dedication to collaborative partnerships within the industry as we work together to deliver innovative solutions to the market."
The emergence of innovative ag biologicals, particularly biofungicides, provides a sustainable and responsible approach to disease management at a time when farmers are left with limited options to effectively address diseases that can pose a major threat to crop yield. These products demonstrate high efficacy in controlling oomycetes while minimizing environmental impact, thereby promoting sustainable agricultural practices.
Lavie Bio's commitment to refining its promising bio fungicides through joint validation trials with Bayer AG serves as a powerful testament to the company's development capabilities, leveraging its innovative BDD platform powered by Evogene's MicroBoost AI tech-engine.
About Lavie Bio Ltd.:
Lavie Bio, a subsidiary of Evogene Ltd., aims to improve food quality, sustainability, and agriculture productivity through the introduction of microbiome-based ag-biological products. Lavie Bio utilizes a proprietary computational predictive platform, the BDD platform, powered by Evogene's proprietary MicroBoost AI tech-engine, harnessing the power of big data, artificial intelligence, and advanced informatics, for the discovery, optimization and development of bio-stimulant and bio-pesticide products.
For more information, please visit www.lavie-bio.com.
Protalix BioTherapeutics, Inc. (PLX) Q4 2023 Earnings Call Transcript
Mar. 14, 2024 1:02 PM ETProtalix BioTherapeutics, Inc. (PLX) Stock
Protalix BioTherapeutics, Inc. (NYSE:PLX) Q4 2023 Earnings Conference Call March 14, 2024 8:30 AM ET
Company Participants
Lauren Merrick - Investor Relations
Dror Bashan - President and Chief Executive Officer
Eyal Rubin - Senior Vice President and Chief Financial Officer
Conference Call Participants
John Vandermosten - Zacks
Operator
Good morning, ladies and gentlemen and welcome to the Protalix BioTherapeutics Fiscal Year 2023 Financial and Business Results Conference Call. As a reminder, this conference call is being recorded. I’ll now turn the conference over to our host, Ms. Lauren Merrick [ph] of LifeSci Advisors, Investor Relations for Protalix. You may now begin.
Lauren Merrick
Thank you, Rob and welcome to the Protalix BioTherapeutics fiscal year 2023 financial results and business update conference call. With me today are Dror Bashan, President and CEO of Protalix; and Eyal Rubin, Senior Vice President and Chief Financial Officer.
A press release announcing the results and the update was issued this morning and is available now on the Protalix website. Please take a moment to read the disclaimer about forward-looking statements in the press release. The earnings release and this teleconference include forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Protalix’s filings with the U.S. Securities and Exchange Commission.
I will now turn the call over to Mr. Dror Bashan. Dror?
Dror Bashan
Thank you, Lauren and welcome everyone to our fiscal year 2023 financial results and business update call. I will begin by reviewing our accomplishments over the past year and recent progress. Following my remarks, Eyal will provide a more detailed review of our financial results. We will then open the line for questions.
2023 marks a significant year for Protalix as we received regulatory approval for our second drug Elfabrio, for the treatment of adult patients with Fabry disease. In May of 2023, both the FDA and the EMA approved Elfabrio for the treatment of adult patients with Fabry disease. Since then, Elfabrio has been granted additional regulatory approvals in other markets like UK, Sweden and the most recently in Israel as well. Our commercial partner, Chiesi global rare diseases remains focused on the commercial launches, which are underway in the United States, in the European Union, in the UK and additional markets where approvals are granted. We are confident that Chiesi will continue to position Elfabrio for success, and we look forward to continued growth of our Elfabrio franchise. Elfabrio is now the second approved drug expressed via our propriety plant, coal-based protein expression system, Protalix, which further highlights the success of our unique platform with these significant milestones behind us and while we are supporting Chiesi’s operations.
We are continuing to focus on building our – the development of our pipeline of innovative assets for the treatment of genetic and non-genetic rare diseases. Our next clinical development candidate is PRX-115, which is being developed for the potential treatment of severe gout. PRX-115 is a recombinant pegylated uricase product candidate that is also produced using our Protalix platform. In March of 2023, we have initiated a Phase 1 first in human clinical trial of PRX-115 to evaluate its safety, pharmacokinetics, pharmacodynamics and immunogenicity. This is a double-blind placebo-controlled single ascending dose study being conducted in New Zealand in approximately 56 patients with elevated uric acid levels. We are pleased to announce that the trial is now fully enrolled, and we expect to report preliminary results from this study in the second quarter of 2024. Our next pipeline of candidate also being expressed for Protalix is PRS-119. PRX-119 is a pegylated recombinant human DNS1 candidate in developing for the potential treatment of diseases associated with neutrophil extracellular scraps or NES. Additional preclinicals are ongoing, and we will update you accordingly, of course.
In addition to PRX-115 and PRX-119, we have multiple preclinical programs in progress, and we look forward to providing you with the updates on these potential development candidates as they become more mature. On the corporate side, in 2023, we welcome Dr. Eliott Foster as Chairman of our Board of Directors and a member of our nominating committee. Dr. Foster succeeded [indiscernible] who retired and we are grateful to the very dedication and leadership since the founding of Protalix. And we are grateful for Eliot’s contribution thus far as we prepare for an exciting phase of development of the company.
Finally, and before turning the call over to Eyal, I want to note that our strong balance sheet provides us with sufficient cash runway to support our operations and in addition, as Eyal will discuss, sales of Elfabrio to Chiesi increased after regulatory approval of Elfabrio, while Chiesi builds its inventories to support a successful launch. We expect sales to clearly – to gradually continue as they anticipate future approvals and launches in additional countries throughout the world.
With that, it is now my pleasure to turn the call over to Eyal for a review of our financials. And Eyal, please go ahead.
Eyal Rubin
Thank you, Dror. And thank you everyone for joining todays call. Let me review our fiscal year 2023 financials. We recorded revenues from selling goods of $40.4 million for the year ended December 31, 2023, an increase of $15.1 million or 60% compared to revenues of $25.3 million for the year ended December 31, 2022. The increase resulted primarily from an increase of $14.1 million in sales of Elfabrio drug product to Chiesi following the approval by the FDA and the EMA of Elfabrio as Dror described, an increase of $0.1 million in sales to Pfizer and of $0.9 million in sales to Brazil.
We recorded revenues from license and R&D services of $25.1 million for the year ended December 31, 2023, an increase of $2.8 million or 13% compared to revenues of $22.3 million for the year ended December 31, 2022. The increase resulted from the $20 million regulatory milestone payment from Chiesi in connection with the FDA approval of Elfabrio, which was partially offset by a decrease of $17.2 million in revenues recognized in connection with the R&D performance obligation under the Chiesi agreement as the company has completed the Phase 3 clinical program thereunder.
Revenues from license and R&D services represent primarily the revenues the company recognized for services provided under the Chiesi agreement. Cost of goods sold was $23 million for the year ended December 31, 2023, an increase of $3.4 million or 17% compared to cost of goods sold of $19.6 million for the year ended December 31, 2022. The increase in cost of goods sold was primarily the result of increase in sales of goods per for Chiesi Brazil and Pfizer. Sales to Chiesi included certain drug substance costs, which had already been recognized as research and development expenses as it was produced as part of the research and development activities.
Accordingly, the related cost of goods sold does not include the cost of subs. For the year ended December 31, 2023, the company total research and development expenses were approximately $17.1 million, comprised of approximately $6.3 million subcontractor related expenses, approximately $7.8 million of salary-related expenses, approximately $0.6 million of material-related expenses and approximately $2.4 million of other expenses. For the year ended December 31, 2022, the company’s total research and development expenses were approximately $29.3 million, comprised of approximately $17.8 million in sub-contractor related expenses, approximately $7.3 million of salary and related expenses, approximately $1.4 billion of material-related expenses and approximately $2.8 million of other expenses.
The decrease in research and development expenses was $12.2 million or 42% for the year ended December 31, 2023, compared to the year ended December 31, 2022. The decrease in issues and development expenses resulted primarily from $11.5 million decrease in subcontractor-related expenses in connection with the PRX-102 clinical trials and a $0.8 million decrease in materials related expenses.
Selling, general and administrative expenses were $15 million for the year ended December 31, 2023, an increase of $3.3 million or 28% from $11.7 million for the year ended December 31, 2022. The increase resulted primarily from an increase of approximately $2.3 million in one-time cash bonuses, share-based compensation and salary and related expenses as well as an increase of $0.3 million in travel conferences and employee training expenses. Financial expenses net was $1.9 million for the year ended December 31, 2023, an increase of $0.5 million or 36% compared to financial expenses of $1.4 million for the year ended December 31, 2022. The increase was primarily due to a decrease of $0.9 million in income related to exchange rates as well as an increase in interest expenses of $0.7 million which was partially offset by a gain recognized due to the conversion of a portion of the 2024 notes of $0.4 million and $0.6 million increase in interest income.
For the year ended December 31, 2023, we recorded income taxes of approximately $0.3 million, a decrease of $0.2 million or 40% compared to tax expenses of $0.5 million for the year ended December 31, 2022. The income taxes resulted primarily from the provision for current taxes and income mainly derived from U.S. taxable global intangible low tax income duty, mainly in respect of Section 174 of the U.S. Tax Cuts and Jobs Act effective in 2022, Section 174 of the TCJA requires all U.S. companies, for tax purposes, to capitalize and subsequently amortize R&D expenses that fall within the scope of Section 174 over 5 years for research activities conducted in the United States and over 15 years for research activities conducted outside of the United States rather than deducting such costs in the current year.
The net income taxes gives effect to a valuation allowance release equal to approximately $3.1 million. Cash and cash equivalents and short-term bank deposits were approximately $44.6 million at December 31, 2023. Net income for the year ended December 31, 2023, was approximately $8.3 million or $0.12 per share basic and $0.09 per share diluted compared to a net loss of $14.9 million or $0.31 per share basic and diluted for the same period in 2022.
I will now turn the call back to you, Dror.
Dror Bashan
Thank you, Eyal. I would like to conclude by expressing how pride we are on of all that Protalix has accomplished throughout 2023. With two drugs expressed via our proven platform are now approved, we are continuing to build our expertise to develop a type of assets to potentially transform the treatment of rare disease. I am grateful for a world-class team who constantly demonstrate unwavering commitment to our mission. We look forward to updating you on our progress as we continue to drive innovation and create long-term value for the patients and stockholders.
Now, I would like to ask the operator to open the call for questions.
Question-and-Answer Session
Operator
[Operator Instructions] And our first question comes from the line of John Vandermosten with Zacks. Please proceed with your question.
John Vandermosten
Great. Thank you and good afternoon Dror and Eyal. If I start off with a question about some of the PRX-102 studies that are going on, I noticed you had one in Japan and one in the United States for pediatric. Can you give us a timeline on how long those might take and what the next steps would be there to get approvals for Japan and for pediatric indication?
Dror Bashan
So, thank you, John. Actually, this study, this is – and are conducted by Chiesi and this is their responsibility. So, I don’t have the timeline in front of me, of course. And this is for them actually to address that. But you can understand that they put a lot of attention and resources into expanding if I may say the franchise, this is clear.
John Vandermosten
Yes. Great. It sounds like they have a lot of opportunities out there. And also, you may not have gotten a lot of information from Chiesi on this, but when you look at your revenues and kind of expenditures for the year, how should we think of those balancing out in terms of free cash flow on the bottom line? Are they going to be pretty equal based on the view right now? Is that how you are planning going forward?
Eyal Rubin
Hey. Thanks for the question, John. So, I don’t know what equal means. But as Dror mentioned, gradually, we expect the sales obviously to grow. And in terms of the free cash flow, it depends how much money you are going to invest in the early stage and the later stage R&D. As I mentioned in previous calls, the sales to Chiesi are comprised of an inventory buildup as well as obviously, commercial sales to the enrolled commercial patients. We expect that these sales are going to eventually grow and gradually, we will get to the place, as we indicated in our presentation, that we believe that Chiesi with a good job can they take in the market.
John Vandermosten
Got it. And then looking at PRX-115, you had mentioned that there is going to be results from that, it seems like in the next couple of weeks. What – assuming those are positive, what are the next steps for that program? Is that Phase 2, or might there be some other pursuit there?
Dror Bashan
So, if indeed, we continue to go forward, of course, when we move into a Phase 2, yes.
John Vandermosten
Okay. And would that be before the end of this year that you would start that Phase 2?
Dror Bashan
This depends – I think it will be between the end to the first half of next year, yes.
John Vandermosten
The first half of next year, okay. Got it. And then last question on PRX-119. What are the next steps for that? Is that something you might put into the clinic this year?
Dror Bashan
Not yet. We are looking into the right indication to continue with. I think this will take further a bit more to decide.
John Vandermosten
Okay. And then any other milestones on the R&D side that we should think about as we progress through 2024?
Dror Bashan
Once there will be something to update, we will update, of course. We are not exactly sitting on our hands. Well, I think we will pretty much, I would say, even intensively in order to make sure that we can add the additional early-stage assets. It is just – we take our time, and I hope we will cut the right move, but will make sense.
John Vandermosten
Okay. Alright. Thank you, Dror. Thank you, Eyal for your answers.
Dror Bashan
You’re welcome.
Operator
[Operator Instructions] Thank you. At this time, there are no additional questions. Gentlemen, would you want to make some further remarks.
Dror Bashan
So, this is to Dror speaking. I just would like to thank everybody again for the time, and again, to thank our shareholders and our employees for supporting us and moving on with our commitment. And we will – of course, we will update you accordingly on any sort of development, and we will meet in the next earnings update. Thank you.
Operator
This will conclude today’s conference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.
Eyal Rubin
Thank you.
MediWound to Report Fourth Quarter and Full Year 2023 Financial Results
https://finance.yahoo.com/news/mediwound-report-fourth-quarter-full-120000694.html
Conference Call and Webcast Scheduled for Thursday, March 21st at 8:30 am Eastern Time
YAVNE, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the Company will release its financial results for the fourth quarter and full year ended December 31, 2023 on Thursday, March 21, 2024.
Following the release, management will host a conference call and live webcast at 8:30 am Eastern Time to discuss the financial results, provide corporate updates, and answer questions.
Dial-in and call details are as follows:
Conference Call & Webcast Details
Toll-Free:
1-833-630-1956
Israel:
1-80-921-2373
International:
1-412-317-1837
Webcast:
To access the call, participants should dial the applicable telephone number above at least 5 minutes prior to the start of the call. An archived version of the webcast will be available for replay on the Investors section of the MediWound website.