On March 23, 2023 Biohaven Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating neurological and neuropsychiatric diseases, including ultra-rare disorders, reported financial results for the fourth quarter ended December 31, 2022, and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, Biohaven Pharmaceutical, MAR 23, 2023, View Source [SID1234629259]). For periods prior to the October 3, 2022 spin-off, the reported financial results present, on a historical basis, the combined assets, liabilities, expenses and cash flows directly attributable to the Company, which have been prepared from Biohaven Pharmaceutical Holding Company Ltd., the former parent, consolidated financial statements and accounting records, and are presented on a stand-alone basis as if the operations had been conducted independently from the former parent. The financial statements for all periods presented, including the historical results of the Company prior to October 3, 2022, are now referred to as "Consolidated Financial Statements."

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Vlad Coric, M.D., Chairman and Chief Executive Officer of Biohaven, commented, "2022 was unequivocally the most defining year since our Company’s formation; with the acquisition by Pfizer for a total consideration of approximately $13 billion including retirement of existing debt, Biohaven is well-capitalized to accelerate development across an extraordinary portfolio spanning mid-to-late-stage and promising discovery assets. The acquisition by Pfizer of Biohaven Pharmaceutical Holding Company Ltd. and the CGRP franchise was a testament to our incredible track record of innovating, developing, commercializing and delivering therapeutic breakthrough medicines, propelled by our unwavering patient focus and data-driven methodical approach. We ultimately delivered multiple first cycle FDA approvals of Nurtec ODT and Vydura ODT in both the acute and prevention of migraine as well as the first intranasal CGRP antagonist, Zavzpret—it’s exciting to see Pfizer take the CGRP franchise global and the benefit that this will have for migraine patients around the world."

Dr. Coric continued, "Today, Biohaven is well-capitalized to accelerate development across an extraordinary portfolio spanning mid-to-late-stage and promising discovery assets. Since the launch of our new company in October, we have already made substantial progress in advancing one of the most innovative and exciting neuroscience portfolios. Our Kv7 ion channel platform has the potential to change the treatment paradigm in the management of epilepsy and mood disorders. The first assets from Biohaven’s Kv7 ion channel platform, BHV-7000 and BHV-7010, are selective Kv7.2 and Kv7.3 activators that lack off-target burdensome side effects. We were pleased to complete our SAD/MAD Phase 1 study of BHV-7000 and report preliminary safety, tolerability and pharmacokinetic data last month; in the study, single doses of up to 100 mg and multiple doses of up to 40 mg daily for 15 days were generally well-tolerated. Importantly, we were encouraged by the lack of sedation, dizziness, fatigue, and ataxia observed in this study – side effects that have historically plagued patients taking available anti-seizure medications. With these results, we plan to initiate an EEG study in the first half of 2023 and Phase 2/3 studies in focal epilepsy and bipolar disorder in the second half of 2023. We are also planning an IND submission for BHV-7010, in epilepsy and mood disorders, and an IND submission for our TRPM3 ion channel antagonist, BHV-2100, in chronic pain; both IND submissions are expected in the second half of 2023."

"Beyond our ion channel platform, our team is advancing novel immune-targeting agents to target neuroinflammation with our degrader platform and recent acquisition of the TYK2/JAK1 asset we added to our pipeline only yesterday. We acquired an exclusive license for BHV-8000, an oral, brain-penetrant, dual TYK2/JAK1 inhibitor offering a unique and exquisite therapeutic approach to addressing brain disorders. There are currently no brain-penetrant, selective, dual TYK2/JAK1 inhibitors approved for brain disorders and we look forward to exploring the vast potential afforded by this compound’s unique therapeutic profile. TYK2/JAK inhibition is a validated mechanism that has led to the approval of peripheral acting agents and our dual TYK2/JAK1 asset will bring one of the most exciting immunoscience targets to the potential treatment of brain disorders. In other pipeline developments, we continue to advance our Phase 3 study evaluating taldefgrobep alfa in patients with spinal muscular atrophy, with 22 sites now activated and enrollment ongoing in the US and EU, and remain on track to complete enrollment in our pivotal Phase 3 study evaluating troriluzole in patients with OCD by year-end 2023. In discovery efforts, we have taken encouraging strides with our burgeoning bispecific platform and were thrilled to share exciting non-human primate data with our IgG degrader, BHV-1300; we expect to submit an IND for BHV-1300 in the second half of 2023. I could not be more enthusiastic about the opportunities ahead for Biohaven – with a world-class, diverse portfolio of assets addressing some of the most critical life-threatening illnesses impacting patients, a plethora of upcoming milestones and multiple INDs supporting continued pipeline development, our highly experienced drug development team, and strengthened capital position – we are well positioned to continue delivering the same impressive results that patients, shareholders, and other key stakeholders have come to expect from our team," Dr. Coric concluded.

Bruce Car, PhD, Chief Scientific Officer of Biohaven added, "We are excited about the promise of our bispecific platform which is advancing multiple compounds including degraders for IgG and IgA, our CD38 targeting therapy for multiple myeloma, and a next generation ADC technology. First, we were thrilled to report data with our first ‘MoDE,’ or molecular degrader of extracellular proteins, where we demonstrated in cynomolgus monkeys that a single dose of our IgG degrader, BHV-1300, reduced IgG levels by 75% from baseline in three days, in comparison to efgartigimod which took 5 to 7 days to achieve a 50% reduction. We separately reported preclinical data from our second MoDE designed to target galactose deficient IgA (Gd-IgA), which is thought to play a pathogenic role in IgA Nephropathy. These early preclinical studies showed the chimeric antibody-ASGPR ligand conjugate specifically mediated endocytosis of Gd-IgA, as opposed to normal IgA. Our team is also advancing next-generation antigen specific degraders that will allow for even more targeted approaches to treat disorders of extracellular proteins. With our antibody recruiting molecule program (ARM), a CD38 targeted cell therapy for multiple myeloma, we have now treated three patients in a Phase 1 trial at Dana-Farber Cancer Institute. The first patient treated has survived to one year, which is encouraging given historic survival rates in this aggressive disease. Taken together, these datasets provide early validation for the power of our bispecific platform and broader discovery efforts."

Full Year and Recent Business Highlights

Ion Channel Platforms – Milestones and Next Steps

Acquired Kv7 channel platform for treatment of epilepsy and other neurologic disorders – In April 2022, the Company closed its acquisition of Channel Biosciences, LLC to acquire a Kv7 channel targeting platform, adding the latest advances in ion-channel modulation to Biohaven’s growing neuroscience portfolio. BHV-7000 (formerly known as KB-3061) is the lead asset from the Kv7 platform and is a potassium channel activator with a profile suggestive of a wide therapeutic index, high selectivity, and significantly reduced GABA-ergic activity. As reported in the second quarter of 2022, the Clinical Trial Application for BHV-7000 was approved by Health Canada and Biohaven subsequently began clinical development.
Reported preliminary Phase 1 results with BHV-7000 – In January 2023, the Company reported preliminary safety, tolerability and pharmacokinetic (PK) data from the Phase 1 SAD/MAD study with BHV-7000. In the study, single doses up to 100 mg and multiple doses up to 40 mg daily for 15 days were safe and well-tolerated, with low rates of adverse events. Most adverse events were mild and resolved spontaneously. No serious or severe adverse events and/or dose limiting toxicities were reported. Importantly, CNS adverse events typically associated with other anti-seizure medications were not reported with BHV-7000; in unblinded data from the MAD cohorts, mild headache was the most common adverse event reported across all dose groups. Drug-related signal for AEs of somnolence, dizziness, fatigue, and ataxia were not observed. With respect to preliminary PK results, the Company exceeded target concentrations for efficacy based on the preclinical maximal electroshock (MES) model, which is clinically validated and predictive of target concentration ranges in humans.
Upcoming studies with BHV-7000 – The Company expects to initiate an EEG study in the first half of 2023 and expects to initiate Phase 2/3 studies in focal epilepsy patients and bipolar disorder patients in the second half of 2023.
Upcoming studies with BHV-7010 – The Company expects to submit an IND with BHV-7010, a next generation Kv7 ion channel activator, in the second half of 2023; the Company intends to investigate its potential in epilepsy and mood disorders.
Additional ion channel development expectations – The Company also intends to submit an IND in the second half of 2023 for BHV-2100, a TRPM3 ion channel antagonist targeting chronic pain.
TYK2/JAK1 Inhibition Platform – Milestones and Next Steps

Acquired BHV-8000, a brain-penetrant inhibitor of TYK2/JAK1, from Highlightll – In March 2023, the Company acquired exclusive rights (ex-China) to a novel, oral, first-in-class, brain-penetrant, dual inhibitor of TYK2/JAK1 offering wide therapeutic index with TYK2 inhibition and high selectivity for JAK1 inhibition without the severely limiting adverse class effects of JAK2/JAK3 inhibitors.
Upcoming studies with BHV-8000 – The Company expects to commence Phase 1 development in 2023.
Myostatin Targeting Taldefgrobep Alfa License – Milestones and Next Steps

Fast Track Designation and Orphan Drug Designation Granted – In February 2023, Taldefgrobep alfa was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). The Company had previously received Orphan Drug Designation in December 2022.
Commenced enrollment in a Phase 3 study with taldefgrobep alfa, an anti-myostatin adnectin for SMA – In July 2022, the Company commenced enrollment in a Phase 3 clinical trial assessing the efficacy and safety of taldefgrobep in SMA. Taldefgrobep targets myostatin, a natural protein that limits skeletal muscle growth, through two mechanisms: lowering myostatin directly and blocking key downstream signaling mechanisms. The Company expects to enroll approximately 180 patients in this randomized, double-blind, placebo-controlled global trial.
Glutamate Modulation Platform – Milestones and Next Steps:

Pivotal Phase 3 trial ongoing with troriluzole in OCD – The Company continues accelerating Phase 3 clinical studies assessing the efficacy and safety of troriluzole in patients with Obsessive Compulsive Disorder (OCD). Biohaven is advancing a 280 mg once daily dose of troriluzole into two double-blind, placebo-controlled Phase 3 clinical trials with identical study designs and plans to enroll up to 700 patients in each of these adjunctive treatment trials across study sites in the United States, Canada and Europe. The Company made several enhancements to the trial to adequately power for previously observed treatment effect, including increasing the sample size in the trial, including a higher dose, and optimizing clinical trial design to minimize placebo effect. The Company expects to complete enrollment by the end of 2023.
Regulatory engagement planned for first half of 2023 in SCA – In May 2022, the Company reported top-line results from a Phase 3 clinical trial evaluating the efficacy and safety of its investigational therapy, troriluzole, in patients with spinocerebellar ataxia (SCA). While the primary endpoint, did not reach statistical significance in the overall SCA population as there was less than expected disease progression over the course of the study, post hoc analysis of efficacy measures by genotype suggested a treatment effect in patients with the SCA Type 3 (SCA3) genotype. SCA3 represents the most common form of SCA and accounted for 41 percent of the study population. The Company intends to interact with the FDA and/or EMA in the first half of 2023. We could seek advice through various formal or informal interactions with regulatory agencies or we could choose to submit a New Drug Application (NDA) if we believe that is warranted from the results of our ongoing post-hoc analyses.
Global Coalition for Adaptive Research (GCAR) commenced enrollment in Glioblastoma Adaptive Global Innovative Learning Environment (GBM Agile) Phase 2-3 adaptive platform trial for patients with glioblastoma – In July 2022, GCAR announced the activation of Biohaven’s troriluzole in GBM AGILE, a patient-centered, adaptive platform trial for registration that tests multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM). GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization.
Bispecific Molecule Platform – Milestones and Next Steps:

Reported preclinical data with extracellular target degrader platform technology (MoDE), a pan-IgG degrader – In January 2023, the Company evaluated the effect of a single dose of immunoglobulin gamma (IgG) degrader, BHV-1300, in cynomolgus monkeys. The Company reported 75% reduction of IgG levels from baseline and noted the observation occurred in three days; the data in this pre-clinical study compares favorably to standard of care therapy efgartigimod, where reduction of IgG levels with efgartigimod was observed to be 50% and had taken 5-7 days. The Company expects BHV-1300 will be ready for IND submission in the second half of 2023. In October 2022, the Company had announced advancements in the development of its MoDE extracellular target degrader platform technology licensed from Yale University for various disease indications, including, but not limited to, neurological disorders, cancer, infectious and autoimmune diseases. Biohaven made further innovations in this ground-breaking technology with new patent applications covering additional targets and functionality.
Reported preclinical data with second MoDE in bispecific platform targeting IgA Nephropathy – In January 2023, the Company reported preclinical data with a second MoDE targeting galactose deficient IgA (Gd-IgA), which is believed to play a pathogenic role in IgA Nephropathy. Specific removal of pathogenic Gd-IgA with preservation of normal IgA potentially permits disease remission without incurring an infection risk. The Company shared preliminary data demonstrating the chimeric antibody-ASGPR ligand conjugate specifically mediated endocytosis of Gd-IgA, as opposed to normal IgA, in an endocytosis assay with HepG2 cells.
Provided update on ongoing Phase 1 trial with BHV-1100 in MRD + post-transplant multiple myeloma patients – In an ongoing Phase 1 study at Dana-Farber Cancer Institute, the first patient treated has survived to one year. Additional patients have been enrolled and recruitment for the study is ongoing.
Corporate Updates:

Company launch – On October 3, 2022, Biohaven Ltd. began operating as a separate independent entity in connection with the merger agreement entered into with Pfizer Inc. in May 2022. As of October 4, 2022, Biohaven Ltd. commenced regular way trading under the symbol "BHVN" on the New York Stock Exchange as an independent, publicly traded company focused on delivering innovative life-changing treatments for neurological and neuropsychiatric diseases, including rare disorders, and leveraging its proven drug development capabilities and proprietary technology platforms to advance a pipeline of therapies. The Company, led by Vlad Coric, M.D. as Chairman and Chief Executive Officer, launched with approximately $257.8 million in cash and no debt.
Public offering – On October 25, 2022, the Company closed its previously announced underwritten public offering of 28,750,000 of its common shares, which includes the full exercise of the underwriters’ option to purchase 3,750,000 additional shares, at the public offering price of $10.50 per share. The gross proceeds raised in the offering, before deducting underwriting discounts and estimated expenses of the offering payable by the Company, were approximately $301.9 million.
Retains Board and key management team and appoints leading industry executives – In connection with the Company launch, Biohaven announced the appointment of Bruce Car, Ph.D. as Chief Scientific Officer; Irfan Qureshi, M.D. as Chief Medical Officer; and Tanya Fischer, M.D., Ph.D. as Chief Development Officer and Head of Translational Medicine.
Operationalized efficient laboratory capabilities to advance the degrader and ion channel programs – The Company’s laboratory capabilities now include space in Cambridge, Massachusetts to enhance the accelerated development of its early assets.
Matthew Buten, Chief Financial Officer, commented, "As we continue efficiently accelerating clinical development and exploring the vast life cycle potential across each of our platforms, we uphold the same judicious strategy that has driven outsized results in years past: ensuring capital access by tactically evaluating opportunities for portfolio rationalization and optimization and continuously assessing partnering, out-licensing, and other creative, non-dilutive financing opportunities. We also periodically review bolt-on acquisition opportunities like BHV-8000, preferentially pursuing clinically validated mechanisms with fast follower potential in large markets and select rare disease opportunities. Biohaven is well capitalized to fund our current programs and we have demonstrated the ability to prioritize near-term value generating inflection points over longer term discovery efforts."

Upcoming Milestones:

Biohaven is progressing its product candidates through clinical programs in a number of common and rare disorders. The Company expects to reach significant pipeline milestones in the coming periods. Biohaven expects to:

Initiate EEG study with BHV-7000 in the first half of 2023: Following Phase 1 study completion, Biohaven expects to initiate pivotal trials in patients with epilepsy and patients with bipolar disorder in the second half of 2023.
Submit IND with BHV-7010 in epilepsy and mood disorders: The Company expects to submit an IND with next-generation Kv7 activator BHV-7010 in epilepsy in the second half of 2023.
Submit IND with BHV-2100 in chronic pain: The Company expects to submit an IND with BHV-2100, a TRPM3 antagonist in the Company’s ion channel platform targeting a pain disorder in 2023.
Commence Phase 1 studies with BHV-8000: The Company expects to commence Phase 1 studies with BHV-8000, an oral, brain-penetrant, dual TYK2/JAK1 inhibitor for immune-mediated brain disorders in 2023.
Complete enrollment in Phase 3 study of troriluzole in OCD in 2023: Two Phase 3 randomized, double-blind, placebo-controlled studies are expected to enroll up to 700 patients (in each trial) across nearly 200 global study sites. The Company anticipates completing enrollment in 2023.
Provide an update on troriluzole in SCA: The Company intends to interact with the FDA and/or EMA in the first half of 2023 on next steps.
Continue advancing Phase 3 clinical studies of taldefgrobep alfa in SMA: The Company expects to enroll approximately 180 patients in the study through the expansion of approximately 40 additional sites.
Continue advancements across multiple neuroscience and immunoscience indications: The Company’s preclinical pipeline includes molecular degraders of extracellular proteins, CD38 targeting antibody recruiting molecules (ARMs), TRP channels, and other undisclosed targets, including those with disease-modifying potential. The Company expects to submit an IND with pan-IgG degrader BHV-1300 in the second half of 2023.
Capital Position:

Cash, cash equivalents and marketable securities as of December 31, 2022 was $465.3 million, excluding $37.7 million of restricted cash, compared to $76.1 million as of December 31, 2021. As of December 31, 2022, restricted cash primarily consisted of restricted cash held by the Company on behalf of the Former Parent of $35.2 million related to the execution of the United States Distribution Services Agreement for which the Company recorded a related liability of $35.2 million as Due to Former Parent on the consolidated balance sheet. On October 3, 2022, in connection with the closing of the acquisition of Biohaven Pharmaceutical Holding Company Ltd. by Pfizer, Biohaven Ltd. launched with a cash balance of approximately $257.8 million. On October 25, 2022, the Company closed a public offering of its common shares, which resulted in net proceeds to the Company of approximately $282.8 million.

Fourth Quarter 2022 Financial Highlights:

Research and Development (R&D) Expenses: R&D expenses, including non-cash share-based compensation costs, were $137.0 million for the three months ended December 31, 2022, compared to $41.8 million for the three months ended December 31, 2021. The increase of $95.2 million was primarily due to an increase of $62.1 million in non-cash share-based compensation, late-stage clinical program spend, and one-time employee costs related to the Pfizer acquisition of the Former Parent in the fourth quarter of 2022. Non-cash share-based compensation expense was $69.4 million for the three months ended December 31, 2022, which included $61.7 million of expense allocated from the Former Parent recognized in connection with the settlement of outstanding Former Parent stock options and RSUs upon the effectiveness of the Separation.

General and Administrative (G&A) Expenses: G&A expenses, including non-cash share-based compensation costs, were $76.4 million for the three months ended December 31, 2022, compared to $9.1 million for the three months ended December 31, 2021. The increase of $67.3 million was primarily due to an increase of $40.6 million in non-cash share-based compensation, and $8.2 million of transaction-related expenses and $8.9 million of one-time employee costs related to the Pfizer acquisition of the Former Parent in the fourth quarter of 2022. Non-cash share-based compensation expense was $46.2 million for the three months ended December 31, 2022, which included $39.7 million of expense allocated from the Former Parent recognized in connection with the settlement of outstanding Former Parent stock options and RSUs upon the effectiveness of the Separation.

Net Loss: Biohaven reported a net loss for the three months ended December 31, 2022, of $201.1 million, or $3.32 per share, compared to $51.9 million, or $1.32 per share, for the same period in 2021. Non-GAAP adjusted net loss for the three months ended December 31, 2022 was $77.3 million, or $1.27 per share, compared to $38.9 million, or $0.99 per share for the same period in 2021. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, and transaction-related costs incurred relating to the Company’s spin-off from Biohaven Pharmaceutical Holding Company Ltd. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below. Net loss per share and Non-GAAP adjusted net loss per share for periods prior to the October 3, 2022 spin-off were calculated based on the 39,375,944 common shares of Biohaven Ltd. common stock distributed to Biohaven Pharmaceutical Holding Company Ltd. shareholders at the time of the Distribution, including common shares issued in connection with Biohaven Pharmaceutical Holding Company Ltd. stock options that were settled on October 3, 2022 and common shares issued in connection with Biohaven Pharmaceutical Holding Company Ltd. restricted stock units that vested on October 3, 2022. The same number of shares is being utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off.

Full Year 2022 Financial Highlights

Note: As described in our Annual Report on Form 10-K, full year results include direct and allocated expenses on a carve-out basis of accounting for the period prior to October 3, 2022, when the Company became a standalone public company.

R&D Expenses: R&D expenses, including non-cash share-based compensation, were $437.1 million for the year ended December 31, 2022, compared to $181.5 million for the year ended December 31, 2021. The increase of $255.6 million was primarily due to an increase in Kv7 platform expense in 2022 related to the $93.7 million acquisition and a $25.0 million milestone, $77.0 million increase in non-cash share-based compensation, and $5.2 million of one-time employee costs related to the Pfizer acquisition of the Former Parent in the fourth quarter of 2022. Non-cash share-based compensation expense was $116.4 million for the year ended December 31, 2022, which included $108.7 million of expense allocated from the Former Parent, including $61.7 million of expense allocated from the Former Parent recognized in connection with the settlement of outstanding Former Parent stock options and RSUs upon the effectiveness of the Separation.

G&A Expenses: G&A expenses, including non-cash share-based compensation costs, were $130.9 million for the year ended December 31, 2022, compared to $37.4 million for the year ended December 31, 2021. The increase of $93.4 million was primarily due to increases of $50.9 million in non-cash share-based compensation expense, and $14.1 million of transaction expenses and $8.9 million of one-time personnel expenses related to related to the Pfizer acquisition of the Former Parent and spin-off of Biohaven Ltd. as an independent, publicly traded company in 2022. Non-cash share-based compensation expense was $71.5 million for the year ended December 31, 2022, which included $70.6 million of expense allocated from the Former Parent, including $39.7 million of expense allocated from the Former Parent recognized in connection with the settlement of outstanding Former Parent stock options and RSUs upon the effectiveness of the Separation.

Net Loss: The Company reported a net loss attributable to common shareholders for the year ended December 31, 2022 of $570.3 million, or $12.75 per share, compared to $213.8 million, or $5.43 per share for the same period in 2021. Non-GAAP adjusted net loss for the year ended December 31, 2022 was $362.7 million, or $8.11 per share, compared to $153.4 million, or $3.90 per share for the same period in 2021. These non-GAAP adjusted net loss and non-GAAP adjusted net loss per share measures, more fully described below under "Non-GAAP Financial Measures," exclude non-cash share-based compensation charges, gains or losses from equity method investment and transaction-related costs incurred relating to the Company’s spin-off from Biohaven Pharmaceutical Holding Company Ltd. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the tables below.

Non-GAAP Financial Measures
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also certain non-GAAP financial measures. In particular, Biohaven has provided non-GAAP adjusted net loss and adjusted net loss per share, adjusted to exclude the items below. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, Biohaven believes the presentation of non-GAAP adjusted net loss, when viewed in conjunction with GAAP results, provides investors with a more meaningful understanding of ongoing operating performance. These measures exclude (i) non-cash share-based compensation, which is substantially dependent on changes in the market price of common shares, (ii) gains or losses from equity method investment, which are non-cash and based on the financial results and valuation of another company that we did not manage or control, and (iii) transaction-related costs incurred relating to the Company’s spin-off from Biohaven Pharmaceutical Holding Company Ltd., which are limited to a specific period of time and related to Biohaven Ltd. being established as a standalone public company.

Biohaven believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding Biohaven’s results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of Biohaven’s ongoing operating performance and are better able to compare Biohaven’s performance between periods. In addition, these non-GAAP financial measures are among those indicators Biohaven uses as a basis for evaluating performance, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

On March 23, 2023 Celyad Oncology (Euronext & Nasdaq: CYAD) (the "Company"), a biotechnology company focused on innovative technologies for chimeric antigen receptor (CAR) T-cell therapies,reported its financial results for the fiscal year 2022 ended December 31, 2022 and provides a business update(Press release, Celyad, MAR 23, 2023, View Source [SID1234629258]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Michel Lussier, Interim Chief Executive Officer of Celyad Oncology, said: "2022 was a crossroad year for Celyad Oncology, with important changes and turning points. We strongly believe all those changes, together with our prior accomplishments, significantly strengthened our position. Having dealt with the 2022 challenges, Celyad has now positively reinvented itself as a leaner, more agile organization. We believe that Celyad is well prepared and has the relevant unique assets and know how to create significant shareholder value in the next few years."
Operational highlights
• Since late 2022, the Company has implemented a differentiated and innovative strategy, increasing its R&D efforts in areas of expertise where it believes it can leverage the differentiated nature of its platform technology and continue to bolster its intellectual property (IP) estate; and
• The Company will continue to explore options to tackle the major current limitations of CAR T-cell therapies through development of its dual targeting CARs with NKG2D capabilities, B7-H6 targeting immunotherapies and multiplexing approach of short hairpin RNAs (shRNAs).
Upcoming Anticipated Milestones
• The Company will provide an update on its shRNA multiplexing and dual CAR platforms and business development in the first half of 2023;
• The Company will take part in the World Oncology Cell Therapy Congress in Boston, US (25-26 April 2023), as well as in the Immuno-Oncology summit in London (20-22 June 2023);
• The Company anticipates the arrival of a new CEO in the first half of 2023; and
• We anticipate fundraising in the first half of 2023.
Full Year 2022 Financial Review
As of December 31, 2022, the Company had cash and cash equivalents of €12.4 million ($13.3 million).
The Company projects that its existing cash and cash equivalents should be sufficient to fund operating expenses and capital expenditure requirements into the fourth quarter of 2023.
After due consideration of detailed budgets and estimated cash flow forecasts for the years 2023 and 2024, the Company projects that its existing cash and cash equivalents will not be sufficient to fund its estimated operating and capital expenditures over at least the next 12 months from the date that the financial statements are issued.
The Company is currently evaluating different financing options to obtain the required funding to extend the Company’s cash runway beyond 12 months from the date the financial statements are issued.
Key financial figures for full-year 2022, compared with full-year 2021, are summarized below:
Selected key financial figures (€ millions) Full year 2022 Full year 2021 Revenue – - Research and development expenses (18.9) (20.8) General and administrative expenses (10.5) (9.9) Change in fair value of contingent consideration 14.7 0.8 Impairment of Oncology intangible assets (35.1) – Other income/(expenses) 9.0 3.4 Operating loss (40.9) (26.4) Loss for the period/year (40.9) (26.5) Net cash used in operations (28.0) (26.6) Treasury position(1) 12.4 30.0 (1) "Treasury position" is an alternative performance measure determined by adding Short-term investments and Cash and cash equivalents from the statement of financial position prepared in accordance with IFRS. The purpose of this measure by Management is to identify the level of cash available internally (excluding external sources of financing) within 12 months.
The Company’s license and collaboration agreements generated no revenue in 2022 and in 2021.
Research and Development (R&D) expenses were €18.9 million in 2022 as compared to €20.8 million in 2021, a year-over-year decrease of €1.8 million. The decrease in the Company’s R&D expenses is primarily driven by the Company’s decision to discontinue some of preclinical and in process development costs after the Company’s decision to adopt and implement a new business strategy over the last few months of 2022, as well as a decrease of the expenses associated with share-based payments (non-cash expenses) related to the warrant plan offered to our employees and directors.
General and Administrative (G&A) expenses were €10.5 million in 2022 as compared to €9.9 million in 2021, an increase of €0.6 million. This increase is primarily related to higher insurances costs and consulting fees partially compensated by the decrease of the expenses associated with the share-based payments (non-cash expenses) related to the warrants plan offered to our employees and directors.
The fair value adjustment (€14.7 million) relating to the contingent consideration and other financial liabilities as of December 31, 2022, is mainly driven by the full reversal of the liability. This liability is a result of business combination accounting (IFRS3) which requires the liability to be recorded unless the possibility of any outflow is remote.
This impairment comes as a result of the Company’s strategic shift in focus away from clinical development and the early stage nature of the implementation of the Celyad 2.0 strategy, which involves shifting from an organization focused on clinical development to one prioritizing R&D discovery and the monetization of its intellectual property (IP) portfolio through partnerships, collaborations and license agreements. To date, no effective sublicence contract nor collaboration contract has been entered into, and as a result there is uncertainty as to the timing and amount of associated short, medium and long term revenues.
Given this uncertainty, and per accounting standards, the Company recognizes a full impairment loss on the remaining value of goodwill, In Process Research and Development, and Horizon Discovery’s shRNA platform, resulting in a non-cash impairment of €35.1 million on a consolidated basis for the financial year ended December 31, 2022.
This accounting conclusion, which reflects the Company’s financial situation as of December 31, 2022, does not affect Management’s commitment to continue in its efforts to pursue the potential monetization of the Company’s IP. If and when such a firm sublicense or collaboration contract occurs and hence increases the probability of revenue, the Management will estimate the reversal of the impairment which will be limited so that the carrying amount of the asset does not exceed its recoverable amount along with the remeasurement of the related contingent liability.
The Company’s other income is principally associated with grants received from the Walloon Region mainly in the form of recoverable cash advances (RCAs) and R&D tax credit income as well as the gain on sale of the CTMU activities:
• Grant income (RCAs): additional grant income has been recognized in 2022 on grants in the form of RCAs. According to IFRS standards, the Company has earned grants for the period amounting to €1.6 million, out of which €0.5 million is accounted for as a financial liability and the remaining €1.1 million as a grant income;
• Grant income (Others): additional grant income has been recognized in 2022 on grants received and from the regional government (for €0.9 million), not referring to RCAs and not subject to reimbursement;
• With respect to R&D tax credit, the current year income is €0.5 million; and
• Gain on sale of CTMU activities (for €5.2 million) results from the terms of the asset purchase agreement between Celyad Oncology and Cellistic under which Cellistic agreed to acquire Celyad Oncology’s Manufacturing Business Unit for a total consideration of €6.0 million.
Net loss for the year ended December 31, 2022 was €40.9 million, or €1.81 per share, compared to a net loss of €26.5 million, or €1.70 per share, for the same period in 2021. As noted above, the increase in net loss between periods was primarily due to the non-cash impairment adjustment on the Oncology intangible assets.
Net cash used in operations for the year ended December 31, 2022, which excludes non-cash effects, amounted to €28.0 million, which is in line with net cash used in operations of €26.6 million for the year ended December 31, 2021.
The net assets of the Company as of December 31, 2022, on a BE-GAAP non-consolidated basis, have fallen below half of the Company’s capital. As a result, in accordance with Article 7:228 of the Belgian Code for Companies and Associations, the Board of Directors plans to submit for a vote, at its May 5, 2023 shareholders’ meeting, its business plan including a proposal to continue the Company’s activities. The Board of Directors will publish a detailed report regarding this proposal on or around April 3, 2023, together with the convocation with proposed resolutions for the shareholders’ meeting.
Annual Report 2022
The Annual Report for the year ended December 31, 2022 will be published on March 23, 2023, and will be available on the Company’s website, www.celyad.com. The Company’s statutory auditor, EY Bedrijfsrevisoren/Réviseurs d’Entreprises BV/SRL (EY), has confirmed that the completed audit has not revealed any material misstatement in the consolidated financial statements. EY also confirmed that the accounting data reported in the press release are consistent, in all material respects, with the consolidated financial statements from which it has been derived.
Conference Call and Webcast Details
A conference call will be held on Friday, March 24th at 1:00 p.m. CET / 8:00 a.m. EDT to review the financial and operating results for full year 2022. Please dial into the call five to ten minutes prior to start time using the appropriate number below and ask to join the "Celyad Oncology SA call":
• United States / International: +1-877-407-9716 or +1-201-493-6779
• Belgium: +32 (0) 800-73-904 (Fixed) or +32 (0) 800-73-566 (Mobile)
Participants may also access to the live webcast link for instant telephone access to the event. Archived recording will be available in the "Events" section of the Celyad website after the event.
Financial Calendar 2023
• May 5th, 2023 First Quarter 2023 Business Update • May 5th, 2023 Annual shareholders meeting • August 3rd, 2023 First Half 2023 Interim Results • November 9th, 2023 Third Quarter 2023 Business Update The financial calendar is communicated on an indicative basis and may be subject to change.

On March 23, 2023 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the year ended December 31, 2022 (Press release, AEterna Zentaris, MAR 23, 2023, View Source;id=258662&p=2262532&I=1206939-c7Z3G6f3m8 [SID1234629257]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over the course of 2022 we made important pipeline progress and timely decisions through our pre-established go/no-go milestones related to the advancement of our development programs. Through this disciplined process, we have further prioritized our pipeline which enables us to focus our resources accordingly. Our active development programs continue to progress and we remain focused on driving enrollment in our ongoing DETECT trial and aim to continue exploring all strategic options for our Macrilen asset," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

Summary of Fourth Quarter and Full Year 2022 Financial Results

All amounts are in U.S. dollars

Cash and cash equivalents

The Company had $50.6 million in cash and cash equivalents at December 31, 2022.

Results of operations for the three-month period ended December 31, 2022

For the three-month period ended December 31, 2022, we reported a consolidated net loss of $12.5 million, or $2.56 loss per common share (basic and diluted), as compared with a consolidated net loss of $2.9 million, or $0.63 loss per common share (basic and diluted) for the three-month period ended December 31, 2021. The $9.6 million increase in net loss is primarily from a $2.5 million increase in total research and development expenses, a $8.3 million charge for the impairment of goodwill (non-cash), intangible assets and other assets, a $0.4 million decrease in net finance income, offset by a $1.5 million increase in revenues and a $0.1 million decrease in cost of sales and selling, office and general administration expenses.

Revenues

Our total revenue for the three-month period ended December 31, 2022 was $2.5 million as compared to $1.0 million for the same period in 2021, representing an increase of $1.5 million, primarily due to $0.5 million increase in License fees and $1.0 million increase in Development services relating to our DETECT trial.
Operating Expenses

Our total operating expenses for the three-month period ended December 31, 2022 was $14.8 million as compared with $4.1 million for the same period in 2021, representing an increase of $10.7 million. This increase arises primarily from a $2.5 million increase in research and development expenses, a $8.3 million charge for the impairment of goodwill (non-cash), intangible assets and other assets, offset by a $0.1 million reduction in cost of sales and selling, general and administrative expenses.
Net Finance Income

For the three-month period ended December 31, 2022, our net finance cost was $0.1 million as compared to $0.2 million net finance income for the three-month period ended December 31, 2021.
Results of operations for the year ended December 31, 2022

For the twelve-month period ended December 31, 2022, we reported a consolidated net loss of $22.7 million, or $4.68 loss per common share (basic and diluted), as compared with a consolidated net loss of $8.4 million, or $1.82 loss per common share (basic and diluted), for the year ended December 31, 2021. The $14.3 million increase in net loss is primarily from a $15.3 million increase in operating expenses offset by an increase of $0.3 million in total revenues and a $0.7 million increase in net finance income.

Revenues

Our total revenue for the twelve-month period ended December 31, 2022 was $5.6 million as compared to $5.3 million for the same period in 2021, representing an increase of $0.3 million, primarily due to $0.3 million increase in development services relating to our DETECT trial.
Operating Expenses

Our total operating expenses for the twelve-month period ended December 31, 2022 was $29.2 million as compared with $13.9 million for the same period in 2021, representing an increase of $15.3 million. This increase arises primarily from a $5.9 million increase in research and development expenses, a $8.3 million charge for the impairment of goodwill (non-cash), intangible assets and other assets, a $0.9 million increase in selling general and administration expenses and a $0.1 million increase in cost of sales.
Net Finance Income

Our net finance income for the twelve-month period ended December 31, 2022, was $0.9 million as compared with $0.2 million for the same period in 2021, representing a increase of $0.7 million. This is primarily due to a $0.7 increase in gains due to foreign currency exchange rates.
Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and full year 2022, as well as the Company’s consolidated financial statements as of December 31, 2022, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.

On March 23, 2023 Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, reported that it will host a conference call and live webcast at 4:30 p.m. Eastern Time on Thursday, March 30, 2023, to review its financial results for the year ended December 31, 2022 and to provide a Company update (Press release, Daré Bioscience, MAR 23, 2023, View Source [SID1234629256]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the conference call via phone, dial (800) 715-9871 (U.S. & Canada) or (646) 307-1963 (international). The conference ID number for the call is 7242530. The live webcast can be accessed under "Presentations, Events & Webcasts" in the Investors section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under "Presentations, Events & Webcasts" in the Investors section of the Company’s website at View Source and available for replay until April 13, 2023.

On March 23, 2023 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading Pan-American (ex-US) specialty pharmaceutical company, reported financial results for its fourth quarter and year ended December 31, 2022. All currency amounts are in thousands except for share and per share amounts (Press release, Knight Therapeutics, MAR 23, 2023, View Source [SID1234629254]). All currencies are Canadian unless otherwise specified.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Financial information as at and for the year ended December 31, 2022 is unaudited.

2022 Highlights

Financials

Revenues were $293,563, an increase of $50,085 or 21% over prior year.
Gross margin of $138,061 or 47% of revenues compared to $115,412 or 47% of revenues in prior year.
Adjusted EBITDA1 was $54,032, an increase of $16,027 or 42% over prior year.
Net loss on financial assets measured at fair value through profit or loss of $20,677.
Net loss was $29,892, compared to net income of $15,675 in prior year.
Cash inflow from operations was $40,481, compared to a cash inflow from operations of $44,618 in prior year.
Corporate Developments

Entered into a five-year secured loan of $52,416 (US$38,500) loan denominated in select LATAM currencies with International Finance Corporation ("IFC").
Executed a settlement agreement with former controlling shareholders of GBT and received $6,030 (US$4,600).
Launched a NCIB in July 2022 to purchase up to 7,988,986 common shares of the Company over the next 12 months.
Purchased 5,649,189 common shares through Knight’s through Normal Course Issuer Bid ("NCIB") at an average price of $5.34 for an aggregate cash consideration of $30,069.
Shareholders re-elected Jonathan Ross Goodman, Samira Sakhia, James C. Gale, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
Hired Leopoldo Bosano as VP Manufacturing and Operations.
Products

Launched Lenvima, Halaven and Rembre in Colombia in Q1-22.
Entered into exclusive license and supply agreements with Rigel Pharmaceuticals to commercialize fostamatinib in LATAM in May 2022.
Entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO oral/IV (netupitant/palonosetron/fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI oral/IV (palonosetron) in Canada in May 2022.
Relaunched AKYNZEO in Canada, Brazil and Argentina, and ALOXI oral/IV in Canada in second half of 2022.
Transferred marketing authorization of Exelon (rivastigmine) and assumed commercial activities in Brazil, Colombia, Argentina, Mexico, Chile, Peru, Ecuador, Canada and re-launched Exelon in Brazil and certain other LATAM countries.
Submitted tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) to ANVISA for regulatory approval in Brazil and Colombia in Q4-22 and Argentina in Q1-23.
In-license three branded generics products for key territories in LATAM.
Obtained regulatory approval for Palbocil (palbociclib) in Argentina in Q4-22.
Submitted two branded generic products (palbociclib and pomalidomide) for regulatory approval in Chile and Colombia in Q4-2022.
Subsequent Event

Purchased an additional 1,279,900 common shares through NCIB for an aggregate cash consideration of $6,577.
_______________________

1 Adjusted EBITDA is a non-GAPP measure, refer to the definitions below in section "Non-Gaap measures" for additional details

"I am excited to announce that we delivered another record year in 2022, with revenues of over $290,000, an increase of 21% over last year and record adjusted EBITDA of over $54,000, an increase of 42% over last year. This growth was generated by the full year effect of Exelon and the continued performance of our recent launches, including Lenvima, Halaven and Rembre in Colombia. While delivering on record results, we have completed the transfer of the commercial activities to Knight for Exelon and Akynzeo in our key markets. We continued to advance our pipeline with the regulatory submission of tafasitamab in Brazil, Colombia and Argentina as well as two branded generic products in Chile and Colombia. In addition, to the in-licensing of Akynzeo, we have expanded our pipeline portfolio in our key Latin America markets with fostamatinib and three branded generic products," said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

SELECT FINANCIAL RESULTS REPORTED UNDER IFRS
[In thousands of Canadian dollars]

[Unaudited]

Change Change
Q4-22 Q4-21 $1 %2 YTD-22 YTD-21 $1 %2
Revenues 81,655 58,273 23,382 40 % 293,563 243,478 50,085 21 %
Gross margin 36,888 28,195 8,693 31 % 138,061 115,412 22,649 20 %
Operating expenses4 67,938 42,829 (25,109 ) 59 % 179,105 128,244 (50,861 ) 40 %
Net (loss) income (15,188 ) (8,301 ) (6,887 ) 83 % (29,892 ) 15,675 N/A N/A
EBITDA3 13,330 4,101 9,229 225 % 53,541 35,865 17,676 49 %
Adjusted EBITDA3 13,821 5,696 8,125 143 % 54,032 38,005 16,027 42 %
1 A positive variance represents a positive impact to net income (loss) and a negative variance represents a negative impact to net income (loss)
2 Percentage change is presented in absolute values
3 EBITDA and adjusted EBITDA are non-GAAP measures, refer to the definitions in section "Non-Gaap measures" for additional details
4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of non current assets

SELECT FINANCIAL RESULTS AT CONSTANT CURRENCY
[In thousands of Canadian dollars]

[Unaudited]

Q4-22 Q4-21 Variance YTD-22 YTD-21 Variance
Excluding impact of IAS 293
Constant Currency3 $1 %2 Constant Currency3 $1 %2
Revenues 83,806 58,370 25,436 44 % 291,770 243,731 48,039 20 %
Gross margin 41,931 29,692 12,239 41 % 150,359 120,694 29,665 25 %
Operating expenses4 46,173 42,509 (3,664 ) 9 % 151,158 124,865 (26,293 ) 21 %
EBITDA3 13,330 4,258 9,072 213 % 53,541 36,376 17,165 47 %
Adjusted EBITDA3 13,821 5,884 7,937 135 % 54,032 38,551 15,481 40 %
1 A positive variance represents a positive impact to adjusted EBITDA and a negative variance represents a negative impact to adjusted EBITDA
2 Percentage change is presented in absolute values
3 Financial results at constant currency and excluding impact of IAS 29, EBITDA and adjusted EBITDA are non GAAP measures, refer to the specific sections for additional details
4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of non-current assets

SELECT BALANCE SHEET ITEMS
[In thousands of Canadian dollars]

[Unaudited]

Change
12-31-22 12-31-21 $ %1
Cash, cash equivalents and marketable securities 172,674 149,502 23,172 15 %
Trade and other receivables 151,669 103,875 47,794 46 %
Inventory 92,489 72,397 20,092 28 %
Financial assets 176,563 192,443 (15,880 ) 8 %
Accounts payable and accrued liabilities 108,730 65,590 43,140 66 %
Bank loans 70,072 35,927 34,145 95 %
1 Percentage change is presented in absolute values

Revenues: For the quarter ended December 31, 2022, excluding the impact of hyperinflation, revenues increased by $27,448 or 49% compared to the same period in prior year. The increase in revenues excluding the impact of hyperinflation is explained by the following:

Excluding impact of IAS 293
Q4-22 Q4-21 Change
Therapeutic Area $ $ $1 %2
Oncology/Hematology 29,343 23,534 5,809 25 %
Infectious Diseases 32,744 20,211 12,533 62 %
Other Specialty 21,760 12,613 9,147 73 %
Total 83,806 56,358 27,448 49 %
1 A positive variance represents a positive impact to net income due to the application of IAS 29 and a negative variance represents a negative impact to net income due to the application of IAS 29
2 Percentage change is presented in absolute values
3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details.

Oncology/hematology: The increase in revenues of $5,809 is driven by growth in our key promoted brands, including new launches of Lenvima and Halaven in Colombia in Q1-22, the growth of key promoted products including Lenvima and Trelstar and the assumption of commercial activities of Akynzeo in Brazil and Canada. This increase is offset by a reduction in revenues of our branded generics products due to their lifecycle including the market entrance of new competitors.
Infectious disease: The portfolio grew by approximately $15,900, excluding the impact of the planned transition and termination of the Gilead Amendment. This growth is due to an increase in patient treatments as our markets reduce COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for Ambisome ("MOH Contract"). Knight recorded $7,500 in revenues, which represents 40% of the expected deliveries under the MOH contract in Q4-22 and the balance of the contract is expected to be delivered in the first six months of 2023
Other specialty: The growth is mainly due to the incremental revenue of $5,092 due to the change in accounting treatment of Exelon from net profit transfer from Novartis to revenues with related cost of sales upon the transition of commercial activities to Knight as well as the timing of purchases of products by certain customers.
For the year ended December 31, 2022, excluding the impact of hyperinflation, revenues increased by $52,532 or 22% compared to the same period in prior year. The growth in revenues excluding the impact of hyperinflation is explained by the following:

Excluding impact of IAS 293
YTD-22 YTD-21 Change
Therapeutic Area $ $ $1 %2
Oncology/Hematology 105,464 89,079 16,385 18 %
Infectious Diseases 116,530 101,650 14,880 15 %
Other Specialty 69,776 48,509 21,267 44 %
Total 291,770 239,238 52,532 22 %
1 A positive variance represents a positive impact to net income due to the application of IAS 29 and a negative variance represents a negative impact to net income due to the application of IAS 29
2 Percentage change is presented in absolute values
3 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to section "Non-GAAP measures" for additional details

Oncology/hematology: The increase in revenues of $15,960 is driven by growth in our key promoted brands, including the launches of Lenvima and Halaven in Colombia in Q1-22, the continued growth of key promoted products including Lenvima, Halaven and Trelstar and the assumption of commercial activities of Akynzeo in Brazil and Canada. This increase is offset by a reduction in revenues of our branded generics products due to their lifecycle including the market entrance of new competitors.
Infectious disease: The portfolio grew by approximately $29,080 due to increase in patient treatments as our markets reduce COVID-19 restrictions, growth of our key promoted products and a one-time sales contract with the Ministry of Health in Brazil for Ambisome ("MOH Contract"). Knight recorded $7,500 in revenues, which represents 40% of the expected deliveries under the MOH contract in Q4-22 and the balance of the contract is expected to be delivered in the first six months of 2023. The growth is offset by an estimated $14,200 due to lower demand for certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19 as well as the planned transition and termination agreement of the Gilead Amendment effective July 1, 2022.
Other specialty: The increase is mainly driven by the timing of the acquisition of Exelon as well as a change in the accounting treatment of Exelon. The full year effect of the Exelon transaction executed on May 26, 2021, represents an incremental revenue of $15,282. The change in accounting treatment from net profit transfer from Novartis to recognition of revenues with related cost of sales upon transition of commercial activities to Knight led to an increase of $6,427 in revenues.
Gross margin: For the quarter ended December 31, 2022, gross margin as a percentage of revenues was 45% compared to 48% in the same prior year period. The decrease in the gross margin, as a percentage of revenues, is explained by the impact of hyperinflation. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 50% in Q4-22 and 51% in Q4-21.

For the year ended December 31, 2022, there was no significant difference in gross margin, as a percentage of revenues, compared to the same prior year period. Excluding the impact of IAS 29, gross margin, as a percentage of revenues, was 52% for year ended December 31, 2022 compared to 50% in prior year. The increase in the gross margin is explained by the change in product mix including the full year effect of the acquisition of Exelon.

Selling and marketing: For the quarter ended December 31, 2022, S&M increased by $2,111 or 17%. Excluding the impact of IAS 29, the increase was $3,162 or 27% driven by an increase in compensation expenses including severance cost of $1,116 due to certain restructuring activities, an increase in selling and marketing activities related to key promoted products including spend on Exelon and Akynzeo as well as certain variable costs such as logistics fees due to higher sales.

For the year ended December 31, 2022, S&M increased by $9,396 or 24%. Excluding the impact of IAS 29, the increase is $9,827 or 26% mainly driven by an increase in compensation expenses including severances of $1,146, an increase in selling and marketing activities related to key promoted products including the spend on Exelon and Akynzeo as well as certain variable costs such as logistics fees due to higher sales.

General and administrative: For the quarter ended on December 31, 2022, there was no significant variation in General and administrative expenses. For the year ended December 31, 2022, G&A increased by $4,852 or 14%. Excluding the impact of IAS 29, the increase is $3,721 or 11%, mainly driven by an increase in compensation expense certain consulting and professional fees offset by the lower costs related to the long-term incentive plan.

Research and development expenses: For the quarter ended on December 31, 2022, there was no significant variation in Research and development expenses. For the year ended December 31, 2022, R&D increased by $2,063 or 16%. Excluding the impact of IAS 29, the increase is $1,653 or 14%, mainly driven by an increase in compensation expenses and medical initiatives.

Amortization of intangible assets: For the year ended December 31, 2022, amortization of intangible assets increased by $10,566 or 26%, mainly explained by the amortization of $11,667 related to the full year effect of the acquisition of Exelon.

Impairment of non-current assets: Under hyperinflation accounting, non-monetary assets including property plant and equipment, right-of-use assets and intangible assets are adjusted by the inflation index and converted back to Canadian Dollar ("CAD") at the closing rate of the reporting period. During a period where the inflation index is higher than devaluation of the Argentine peso relative to the CAD, the value of the non-monetary assets increases when converted to CAD. During 2022, the increase in the value of non-monetary assets in Argentina due to hyperinflation accounting, resulted in an impairment of $21,654. The loss represents a write-down of certain right-of-use assets, property, plant and equipment in Argentina, and intangible assets related to branded generics intellectual property to its recoverable amount.

In addition, during 2022, the Company recorded an additional impairment loss of $2,330 representing the write-down of the upfront and certain milestones payments made under certain product license agreements as a result of changes in commercial expectations.
Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter and year ended December 31, 2022, interest income was $4,263 and $10,632, an increase of 94% or $2,067 and 44% or $3,250 respectively, compared to the same period in prior year due to higher interest rates on cash and marketable securities as well as interest earned on strategic loans.

Interest expense: The increase for the quarter and year ended December 31, 2022, is due to the increase of the Certificados de Depositos Interfinancieros (Brazil interbank lending rate) ("CDI") and Indicador Bancario de Referencia (Colombia interbank lending rate) ("IBR") rates throughout 2022, partially offset by lower average loan balance due to partial repayment of Itaú Unibanco Brasil and Bancolombia bank loans.

In December 2022, the Company entered into a loan with IFC for an amount of $52,416 denominated in BRL, COP, CLP and MXN with interest rates ranging between 7.86% and 15.83% ("IFC Loan"). The interest expense on bank loans is expected to increase in 2023 due the IFC Loan as well as any future increases in variable interest rates.

Adjusted EBITDA: For the quarter ended December 31, 2022, adjusted EBITDA increased by $8,125 or 143%. The growth in adjusted EBITDA is driven by an increase in gross margin of $8,693, offset by an increase in operating expenses.

For the year ended December 31, 2022 adjusted EBITDA increased by $16,027 or 42%. The growth in adjusted EBITDA is driven by an increase in gross margin of $22,649 offset by an increase in operating expenses.

Net loss or income: For the quarter ended December 31, 2022, net loss was $15,188 compared to net loss of $8,301 for the same period last year. The increase in net loss mainly resulted from the above-mentioned items and (1) an increase in income tax recovery of $1,824 in the fourth quarter of 2022 due to the recognition of certain deferred tax assets as well as (2) a higher net gain on the revaluation of financial assets measured at fair value through profit or loss of $8,824 in the fourth quarter of 2022 versus a net gain of $2,300 in the prior year period mainly due to unrealized gains on revaluation of the strategic fund investments resulting from positive mark-to-market adjustments as a result of the increase in the share prices of one of the publicly-traded equities held by one of the funds, (3) foreign exchange loss of $1,633 versus a loss of $3,485 in the prior year period due to appreciation of the CAD versus the US dollar, and (4) a other expense for the quarter ended December 31, 2022 increase by $2,285 compared to the same period in prior year mainly due to the increase in a provision related to certain import tax claims.

For the year ended December 31, 2022, net loss was $29,892 compared to net income of $15,675 in prior year. The variance mainly resulted from the above-mentioned items and (1) an income tax recovery of $17,125 in 2022 due to the recognition of certain deferred tax assets due to timing differences related to our financial assets, impairment of certain non-current assets and certain intercompany transactions, compared to a prior year income tax recovery of $8,985, (2) a lower net loss on the revaluation of financial assets measured at fair value through profit or loss of $20,677 in 2022 versus a net gain of $18,944 in prior year mainly due to unrealized losses on revaluation of the strategic fund investments as a result of the decline in the share prices of the publicly-traded equities held by our strategic fund investments due to general market conditions, as well as (3) foreign exchange gain of $7,442 versus a loss of $3,737 in the prior year period due to appreciation of the US dollar compared to CAD in 2022, and (4) gain of $6,030 as a result of execution of settlement agreement and general release with the former shareholders of GBT, partially offset by expense due to the change in an accounting provision for a potential liability.

Cash, cash equivalents and marketable securities: As at December 31, 2022, Knight had $172,674 in cash, cash equivalents and marketable securities, including $18,961 [USD 14,000] pledged as restricted cash collateral under the IFC Loan. The increase of $23,172 or 15% as compared to December 31, 2022 primarily relates to cash generated through operating activities and funds received under the IFC Loan offset by cash outflows from shares purchased through the NCIB, the in-licensing of AKYNZEO and ALOXI from Helsinn as well as fostamatinib from Rigel, repayments on bank loans and foreign exchange gain on cash and cash equivalents.

Financial assets: As at December 31, 2022, financial assets were at $176,563, a decrease of $15,880 or 8%, as compared to the prior year, mainly due to a negative mark-to-market adjustments of $23,325 driven mostly by the decline in the share prices of the publicly-traded equities held by our strategic fund investments due to general market conditions, fund distributions of $6,478, decrease in equity investments and derivatives of $1,918 mainly due to disposal of Medimetriks offset by capital calls of $6,307, loans issued of $2,723 and foreign exchange gains of $6,245.

Bank Loans: As at December 31, 2022, bank loans were at $70,072, an increase of $34,145 or 95% as compared to the prior period, mainly due to the IFC loan offset by loan repayments.

Product Updates

Commercial Execution

In the first quarter of 2022, Knight launched three products in Colombia in Oncology/Hematology namely Lenvima for differentiated thyroid cancer and unresectable hepatocellular carcinoma, Halaven for metastatic breast cancer and soft tissue sarcoma and Rembre, a branded generic product, for chronic myeloid leukemia.

As at March 22, 2023, the marketing authorizations of Exelon for Brazil, Colombia, Argentina, Mexico, Chile, Peru, Ecuador and Canada were transferred to Knight. In addition, Knight has assumed the commercial activities of Exelon in Colombia in Q2-22, Brazil, Argentina & Chile in Q3-22 and Mexico, Peru, Ecuador & Canada in Q4-22.

On May 12, 2022, Knight entered into an exclusive license, distribution and supply agreement with Helsinn for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil and select LATAM countries and ALOXI oral/IV (palonosetron) in Canada. Knight has assumed commercial activities and re-launched AKYNZEO in Brazil and Argentina in July 2022 and in Canada in Q4-22.

On July 1, 2022, Knight has entered into a transition and termination agreement with Gilead for a portfolio of HIV and HCV products ("Gilead Amendment"). The portfolio is currently distributed by Knight in one or more of the following countries: Colombia, Peru, Ecuador, Bolivia and Paraguay. As part of the Gilead Amendment, Knight distributes the products under a mutually agreed amended commercial and financial terms, until the earlier of April 30, 2023 and the completion of the regulatory, logistical and commercial transition on a per country and product basis. The Gilead Amendment does not impact any products distributed by the Company on behalf of Gilead in Brazil.

Advancing our pipeline portfolio

Knight submitted tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) for regulatory approval to ANVISA in Brazil in October 2022, INVIMA in Colombia in December 2022 and ANMAT in Argentina in January 2023. Knight expects to submit tafasitamab in other key LATAM countries in the first half of 2023.

In December 2022, Knight obtained the regulatory approval for Palbocil (palbociclib) in Argentina. Knight launched Palbocil in Argentina in March 2023 and filed for regulatory approval for Bapocil (palbociclib) in Colombia and Chile in Q4-2022. Palbocil is indicated for the treatment of patients with hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women or fulvestrant in patients with disease progression after prior endocrine therapy.

In addition, during the fourth quarter of 2022, Knight also submitted a branded generic of for regulatory approval in Chile and Colombia. Furthermore, the Company has in-licensed three branded generic products for our key markets in Latin America.

NCIB

On July 12, 2022, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2022 NCIB"). Under the terms of the 2022 NCIB, Knight may purchase for cancellation up to 7,988,986 common shares of the Company which represented 10% of its public float as at June 30, 2022. The 2022 NCIB commenced on July 14, 2022 and will end on the earlier of July 13, 2023 or when the Company completes its maximum purchases under the NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the NCIB. Under Knight’s automatic share purchase plan, the broker may purchase common shares which would ordinarily not be permitted due to regulatory restrictions or self-imposed blackout periods.

For the year ended December 31, 2022, the Company purchased 5,649,189 (2021: 12,321,864) common shares at an average price of $5.34 (2021: $5.23) for aggregate cash consideration of $30,069 (2021: $64,415). Subsequent to December 31, 2022, the Company purchased an additional 1,279,900 common shares at an average purchase price of $5.14 for an aggregate cash consideration of $6,577.

Financial Outlook

Knight provides guidance on revenues1 on a non-GAAP basis. This is due to both the difficulty in predicting Argentinian inflation rates and its IAS 29 impact.

For fiscal 2023, Knight expects to report $280 to $300 million in revenue and adjusted EBITDA, as a percentage of revenues, between 13% to 15% of revenue. The guidance is based on a number of assumptions, including but not limited to the following:

no revenues for business development transactions not completed as of March 22, 2023
discontinuation of certain distribution agreements
no interruptions in supply whether due to global supply chain disruptions or general manufacturing issues
no new generic entrants on our key pharmaceutical brands
no unforeseen changes to government mandated pricing regulations
successful commercial execution on product listing arrangements with HMOs, insurers, key accounts, and public payers
successful execution and uptake of newly launched products
no significant restrictions or economic shut down due to the COVID-19 pandemic
foreign currency exchange rates remaining within forecasted ranges
Should any of the assumptions differ, the financial outlook and the actual results may vary materially. Refer to the risks and assumptions referred to in the Forward-Looking Statements section of this news release for further details.

"Our team has been successfully executing on our pan-American ex US strategy and has built a profitable business with a unique platform and a strong foundation from where to continue growing over the long term. We ended 2022 by delivering record revenues and adjusted EBITDA as a result of growing the current portfolio as well as adding new products that leverage our existing infrastructure. Looking ahead, while we will face headwinds with the entrance of new competitors on certain of our banded generic products as well as incur investments related to promoted products, Knight is expected to continue to generate strong cash flows from operations and with over $150,000 of cash and $175,000 of financial assets, we remain well positioned to execute on our mission to acquire, in-license, develop and commercialize pharmaceutical products in Latin America and Canada." said Jonathan Ross Goodman, Executive Chairman of Knight Therapeutics Inc.

1 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to the definitions in section "Non-Gaap measures" for additional details

Conference Call Notice

Knight will host a conference call and audio webcast to discuss its fourth quarter and year-end results today at 8:30 am ET. Knight cordially invites all interested parties to participate in this call.

Date: Thursday, March 23, 2023
Time: 8:30 a.m. ET
Telephone: Toll Free: 1-888-256-1007 or International 1-647-484-0475
Webcast: www.gud-knight.com or Webcast
This is a listen-only audio webcast. Media Player is required to listen to the broadcast.

Replay: An archived replay will be available for 30 days at www.gud-knight.com