On March 24, 2022 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its consolidated financial results for the year ending December 31, 2021 (Press release, Innate Pharma, MAR 24, 2022, View Source [SID1234610844]). The consolidated financial statements are attached to this press release.

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"Throughout 2021, we made key progress across our portfolio – announcing promising data with our proprietary pipeline as well as the start of a new pivotal study by our partner AstraZeneca with our most advanced pipeline asset, monalizumab. Highlights from our pipeline included the encouraging lacutamab data in a subtype of cutaneous T-cell lymphoma, mycosis fungoides (MF), and the initiation of trials of the product in the broader indications of peripheral T-cell lymphomas (PTCL). We also showed further validation with our multi-specific NK cell engager platform, ANKETTM, including the start of a Phase 1 trial with Sanofi," said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. "The value in Innate is the strength and depth of our core R&D efforts, as we look to progress our pipeline in house, or with partnerships. We look forward to new milestones in the coming year including readouts from the lacutamab program, further progress in our early-stage R&D activities in ANKETTM and the adenosine franchise and not least in continued development of monalizumab."

Webcast and conference call will be held today at 2:00pm CET (9:00am EDT)

Access to live webcast:

View Source

Participants may also join via telephone using the dial-in details below:

France: 0805 620 704

United States: 1 844 200 6205 / 1 646 904 5544

United Kingdom: 44 208 0682 558 / 44 808 189 648

All other locations: +1 929 526 1599

Access code: 834852

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company website for 90 days following the event.

Pipeline highlights:

Lacutamab (IPH4102, anti-KIR3DL2 antibody):

The Company announces the opening of a new mycosis fungoides (MF) all-comers cohort in the TELLOMAK study. The all-comers cohort will recruit both KIR3DL2 expressors and non-expressors to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay as a companion diagnostic. The KIR3DL2 non-expressing Cohort 3 has been closed to recruitment. As per the Simon 2-stage design, the number of responses to move to stage 2 was not reached, as such, recruitment into this cohort is stopped. Cohort 3 included KIR3DL2 non-expressing patients assigned via a KIR3DL2 immunohistochemistry assay for use on frozen biopsy samples and as a tool for stratification.
In June 2021, the Company announced preliminary data from its Phase 2 TELLOMAK trial, in which lacutamab demonstrated a 35% overall global response rate in patients with MF that express KIR3DL2 (Cohort 2). This first trial data set also established safety and demonstrated skin improvement. Lacutamab reached the pre-determined threshold to advance to stage 2 (six confirmed responses). These results were presented in an oral presentation at the 16th International Conference on Malignant Lymphoma (16-ICML).
Two parallel clinical trials to study lacutamab in patients with KIR3DL2-expressing, relapsed/refractory peripheral T-cell lymphoma (PTCL) are ongoing:
Phase 1b trial: a Company-sponsored Phase 1b clinical trial to evaluate lacutamab as a monotherapy in patients with KIR3DL2-expressing relapsed PTCL.
Phase 2 KILT (anti-KIR in T Cell Lymphoma) trial: The Lymphoma Study Association (LYSA) initiated an investigator-sponsored, randomized trial to evaluate lacutamab in combination with chemotherapy GEMOX (gemcitabine in combination with oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL.
ANKET (Antibody-based NK cell Engager Therapeutics):

In December 2021, the Company announced that the first patient was dosed in a Phase 1/2 clinical trial by Sanofi, evaluating IPH6101/SAR443579, the first NKp46/CD16‑based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS). The purpose of the dose escalation and dose expansion study, which is sponsored by Sanofi, is to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKETTM asset, in various CD123-expressing hematological malignancies. The start of the trial has triggered a milestone payment from Sanofi to Innate.
In November 2021, Innate Pharma in collaboration with Sanofi, presented preclinical data from Innate’s proprietary, multi-specific NK cell engager platform, ANKETTM, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). Data on IPH6101/SAR443579, using Innate’s proprietary multi-specific antibody format (Gauthier et al. Cell 2019) that targets CD123 on acute myeloid leukemia (AML) cells and co-engages NKp46 and CD16a on NK cells was presented. In preclinical studies, IPH6101/SAR443579 demonstrated potent antitumor activity against AML cell lines, including those resistant to ADCC by a comparator anti-CD123 antibody. IPH6101/SAR443579 also promoted strong and specific NK-cell activation and induced cytokine secretion only in the presence of AML target cells. In addition, IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.
In June 2021, the Company presented new data on its ANKETTM platform, at the Federation of Clinical Immunology Societies meeting. Specifically, Innate shared data from its tetra-specific ANKETTM molecule, which is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a cytokine receptor (IL-2Rb) and a tumor antigen via a single molecule. In preclinical studies, the tetra-specific ANKETTM demonstrated in vitro the ability to induce human NK cell proliferation, cytokine production and cytolytic activity against cancer cells expressing the targeted antigen. The tetra-specific ANKETTM also demonstrated in vivo anti-tumor efficacy in several tumor models, allowing regression of established tumors as well as control of metastasis, associated with increased NK cell infiltration, cytokine and chemokine production at the tumor site. ANKETTM also showed a pharmacodynamic effect, low systemic cytokine release and a manageable safety profile in non-human primates.
In January 2021, it was announced that Sanofi will transition IPH6101/SAR443579 into investigational new drug (IND)-enabling studies. The decision triggered a €7 million milestone payment from Sanofi to Innate. In addition, in January 2021, a GLP-tox study was initiated for the IPH6101/SAR443579 program.
IPH64, the other drug candidate of the research collaboration with Sanofi is progressing and the Company look forward to updates on this asset.
The Company’s proprietary tetra-specific ANKETTM IPH65 is progressing to IND enabling studies.
Monalizumab (anti-NKG2A antibody), partnered with AstraZeneca:

In March 2022, the Phase 2 NeoCOAST study assessing the safety and efficacy of neoadjuvant durvalumab in combination with chemotherapy and oleclumab or monalizumab and adjuvant treatment in participants with resectable, early-stage non-small cell lung cancer (NSCLC) has been accepted for an oral presentation on 11 April 2022 at the Annual Meeting 2022 of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).
In February 2022, AstraZeneca initiated a Phase 3 clinical trial, PACIFIC-9, evaluating durvalumab (anti-PD-L1) in combination with monalizumab (anti-NKG2A) or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III NSCLC who have not progressed following definitive platinum-based concurrent chemoradiation therapy (CRT).
In December 2021, the Company presented data from the Phase 2 expansion cohort (‘cohort 3’), exploring the triplet combination of monalizumab, cetuximab and durvalumab in the first-line treatment of patients with recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2021. After a median follow-up of 16.3 months, preliminary data suggest anti-tumor activity in the triplet of monalizumab, cetuximab and durvalumab in first-line treatment of R/M HNSCC. As of August 1, 2021, 40 patients were enrolled. Thirteen patients had a confirmed response with a 32.5% overall response rate (95% confidence interval (CI): 20-48), including three complete responses. Seven out of 13 responders were still on treatment. Median duration of response was not yet reached (95% CI: 7.1-not available). The survival rate at 12 months was 58.6% (95% CI: 45-77) and the median overall survival was 15 months (95% CI: 11.4 – not available).
In September 2021, AstraZeneca commenced a Phase 2 clinical study, NeoCOAST-2, that includes a treatment arm with durvalumab in combination with chemotherapy and monalizumab in resectable, early-stage NSCLC.
In September 2021, AstraZeneca presented a late-breaker abstract on the randomized COAST Phase 2 trial in patients with unresectable, Stage III NSCLC at the ESMO (Free ESMO Whitepaper) Congress. The presentation highlighted progression-free survival (PFS) and overall response rate (ORR) results for durvalumab in combination with monalizumab, Innate’s lead partnered asset, and oleclumab, AstraZeneca’s anti-CD73 monoclonal antibody. After a median follow-up of 11.5 months, the results of an interim analysis showed a 10-month PFS rate of 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone in unresectable, Stage III NSCLC patients following chemoradiation therapy. The results also showed an increase in the primary endpoint of confirmed ORR for durvalumab plus monalizumab over durvalumab alone (36% vs. 18%).
IPH5201 (anti-CD39), partnered with AstraZeneca:

AstraZeneca is conducting a Phase 1 trial in solid tumors with IPH5201 alone or in combination with durvalumab (anti-PD-L1). The data is expected to be presented in 2023. Innate is in discussions with AstraZeneca on potential next steps for this program.
IPH5301 (anti-CD73):

In March 2022, The Institut Paoli-Calmettes announced that the first patient had been dosed in the investigator-sponsored Phase 1 trial of IPH5301 (CHANCES). The trial will be conducted in two parts, Part 1, the dose escalation, followed by a Part 2 safety expansion study cohort. Part 2 will evaluate IPH5301 in combination with chemotherapy and trastuzumab in HER2+ cancer patients.
Avdoralimab (IPH5401, anti-C5aR antibody):

In July 2021, the Company announced that FORCE (FOR COVID-19 Elimination), the investigator-sponsored, Phase 2 clinical trial evaluating the safety and efficacy of avdoralimab, in COVID-19 patients with severe pneumonia, did not meet its primary endpoints in all three cohorts of the trial. Results from this trial, including translational data, are planned to be submitted for publication. The Company’s COVID-19 activities were covered by public funding from the French government.
Following a strategic review, the Company will now solely pursue avdoralimab in bullous pemphigoid, an inflammatory disease, through an investigator-sponsored study and stop further development in all other indications. Data in bullous pemphigoid is now expected in 2024.
Corporate Update:

In February 2022, Mrs Tracy Rossin, VP, Global Head of Communications, decided to pursue another opportunity outside the Company. Mr Henry Wheeler, Vice President of Investor Relations, who joined Innate in June 2021 is now responsible for Investor Relations and Communications.
In January 2022, Mr Nicola Beltraminelli PhD was appointed as Vice President, Chief Development Officer of Innate responsible for non-clinical development. Mrs Frederique Brune, Vice President Development CMC and Supply Chain decided to pursue another opportunity outside the company. Mr Beltraminelli brings more than 20 years of biotech experience to the role, and specifically in the development of biologic products from early discovery to GMP manufacture. Most recently, Mr Beltraminelli served as Chief Technical Officer at Lysogene, where he led the CMC activities for two late-stage assets.
In January 2022, Innate Pharma announced that it had obtained €28.7M in non-dilutive financing in the form of State Guaranteed Loans from Société Générale and BNP Paribas. The two agreements were signed and funds received in December 2021.
In November 2021, Jen Butler, Head of Global Commercial and US General Manager left her position at the Company.
In June 2021, Bpifrance informed Innate that its permanent representative at Innate’s Supervisory Board, Mrs Maïlys Ferrere will be replaced by Mr Olivier Martinez, Senior Investment Director in the Life Sciences Investments Department of the Direction of Innovation of Bpifrance, who has been Observer of Innate’s Supervisory Board since 2010.
Announced on May 28, 2021, Novo Nordisk A/S, represented by Marcus Schindler, M.D., decided not to seek re-election to the Supervisory Board due to Dr. Schindler’s new role as Executive Vice President Research & Early Development and Chief Scientific Officer of Novo Nordisk A/S. Novo Nordisk A/S remains a shareholder in the Company but no longer has a seat on its Supervisory Board.
Frederic Lombard was appointed as Chief Financial Officer on April 1, 2021. Mr Lombard has more than 20 years of financial experience in the pharmaceutical industry, holding senior finance roles at Ipsen, AstraZeneca and Novartis. Laure-Hélène Mercier, Executive Vice President, Chief Financial Officer and member of the Executive Board, decided to step down from her position, after leading the Company through more than 14 years of growth, including an initial public offering in the US. She left the Company on January 2022.
Financial highlights for 2021:

The key elements of Innate’s financial position and financial results as of and for the year ended December 31, 2021 are as follows:

Cash, cash equivalents, short-term investments and financial assets amounting to €159.7 million2 (€m) as of December 31, 2021 (€190.6m as of December 31, 2020), including non-current financial instruments amounting to €39.9m (€38.9m as of December 31, 2020).
As of December 31, 2021, financial liabilities amount to €44.3m (€19.1m as of December 31, 2020). This change is mainly linked to proceeds relating to State-Guaranteed Loans (Prêts Garantis par l’Etat "PGE") of €28.7m from Société Générale (€20.0m) and BNP Paribas (€8.7m) collected by the Company on December 2021.
Revenue and other income from continuing operations3 amounted to €24.7m in 2021 (2020: €69.8m, -64.6%). It mainly comprises revenue from collaboration and licensing agreements (€12.1m in 2021 vs €56.2m in 2020, -78.4%), and research tax credit (€10.3m in 2021 vs €13.1m in 2020, -21.2%):
Revenue from collaboration and licensing agreement with AstraZeneca amounted to €9.1m in 2021 (€49.0m in 2020, -81.4%) and mainly resulted from (i) the spreading of the upfront and opt-in payments received from AstraZeneca and (ii) the invoicing to AstraZeneca of certain fees for the work performed by Innate for the partnered programs. The variation between the two periods is notably explained by the (i) decrease in direct monalizumab research and development costs over the period, in connection with the Phase 1 & 2 trials maturity, and (ii) the absence of revenue relating to IPH5201 in 2021, the Company having fulfilled all of its commitments on preclinical work related to the start of Phase 1 as of December 31,2020.
Revenue of €3.0m from Sanofi following the initiation of a GLP-tox Study and the launching of the first Phase 1 clinical trial in humans in relapsed of refractory AML with IPH6101/SAR443579, respectively in January and December 2021.
The variation in the research tax credit mainly results from a decrease in the amortization for the intangible assets related to acquired licenses (monalizumab and IPH5201).
Operating expenses from continuing operations amounted to €72.5m in 2021 (2020: €68.7m, +5.6%):
General and administrative (G&A) expenses from continuing activities amounted to €25.5m in 2021 (2020: €19.0m, +34.4% 4). This increase results cumulatively from (i) an increase in wages mainly resulting from restructuring costs and higher annual bonuses level in 2021, (ii) an increase in non-scientific advisory fees and (iii) an increase in other general and administrative expenses.
Research and development (R&D) expenses from continuing activities amounted to €47.0m in 2021 (2020: €49.7m, -5.4%). This variation mainly results from a (i) decrease in depreciation and amortization of intangible assets acquired by the Company (IPH5201, fully amortized since December 2020, and monalizumab) partly offset by (ii) an increase in direct research and development expenses (clinical and non-clinical).
A net financial income of €2.3m in 2021 (2020: €1.9m loss).
A net loss from Lumoxiti discontinued operations of €7.3m in 2021 (2020 : net loss of €63.2m, -88.4%) mainly resulting from the Settlement Amount of $6.2m5 (€5.5m as of December 31, 2021) to be paid to AstraZeneca on April 30, 2022, as part of the Termination and Transition agreement effective as of June 30, 2021. The net loss in 2020 mainly resulted from the full impairment of Lumoxiti rights following the Company decision to return the marketing rights of Lumoxiti in the United States and in Europe to AstraZeneca.
A net loss of €52.8m in 2021 (2020: net loss of €64.0m).

On March 24, 2022 Scenic Biotech reported Two independent studies were published this week on Scenic’s inflammation drug target QPCTL (Press release, Scenic Biotech, MAR 24, 2022, View Source [SID1234610883]). The studies were conducted by Genentech and Scenic’s SAB member Ton Schumacher at the Netherlands Cancer Institute. The publications provide proof of concept in preclinical models for the use of QPCTL inhibition in combination with other checkpoint inhibitors for the treatment of solid tumours.

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On March 24, 2022 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, 2021 (Press release, Knight Therapeutics, MAR 24, 2022, View Source [SID1234610920]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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2021 Highlights

Financials

Revenues were $243,478, an increase of $43,959 or 22% over prior year.
Gross margin of $115,412 or 47% compared to $81,690 or 41% in prior year.
Adjusted EBITDA1 was $38,005, an increase of $21,168 or 126% over prior year.
Net gain on financial assets measured at fair value through profit or loss of $18,944.
Net income was $15,675, compared to net income of $31,760 in prior year.
Cash inflow from operations was $44,618, compared to a cash outflow from operations of $12,205 in prior year.
Corporate Developments

Purchased 12,321,864 common shares through Knight’s Normal Course Issuer Bid ("NCIB") at an average price of $5.23 for an aggregate cash consideration of $64,415.
Performed leadership change with Samira Sakhia assuming role of CEO and Jonathan Goodman assuming role of Executive Chairman effective September 1, 2021.
Promoted Amal Khouri to Chief Business Officer.
Hired Jeff Martens as Global VP Commercial, Monica Percario as Global VP Scientific Affairs, Daniela Marino as Global VP Legal and Compliance and Susan Emblem as Global VP Human Resources.
Shareholders re-elected James C. Gale, Jonathan Ross Goodman, Samira Sakhia, Robert N. Lande, Michael J. Tremblay, Nicolás Sujoy and Janice Murray on the Board of Directors.
Products

Acquired, in May 2021, the exclusive rights to manufacture, market and sell Exelon (rivastigmine) in Canada and Latin America for an upfront and milestone payment of $217,331 [US$180,000].
Entered into exclusive supply and distribution agreement with Incyte for tafasitamab and pemigatinib for Latin America.
Launched Ibsrela (tenapanor) in Canada for the treatment of irritable bowel syndrome with constipation ("IBS-C").
Obtained regulatory approval for NERLYNX (neratinib) to treat subset of HER2-positive metastatic breast cancer patients in Canada.
Obtained regulatory approval for Halaven (eribulin mesylate) injection to treat locally advanced or metastatic breast cancer in Colombia and to treat advanced or metastatic liposarcoma.
Obtained regulatory approval for Lenvima (lenvatinib) to treat radioiodine refractory differentiated thyroid cancer ("RR-DTC") and unresectable hepatocellular carcinoma ("u-HCC") in Colombia.
Obtained regulatory approval of Rembre (dasatinib) to treat chronic myeloid leukemia in Colombia.
1 Adjusted EBITDA is a non-GAPP measure, refer to the definitions below for additional details.

Strategic Investments

Disposed of 315,600 common shares of Medexus for total proceeds of $2,624 realizing a gain of $1,639.
Received distributions of $30,931 from strategic fund investments, including $10,906 (US$8,774) final distribution from the liquidation of NEMO II fund, and realized a gain of $16,644.
Subsequent Events

Launched Lenvima and Rembre in Colombia in February 2022.
Launched Halaven in Colombia in March 2022.
Hired Leopoldo Bosano as VP Manufacturing and Operations in March 2022.
Purchased an additional 933,715 common shares through NCIB for an aggregate cash consideration of $4,997.
"I am excited to announce that 2021 was a record-setting year in Knight’s history, despite the ongoing challenges posed by the pandemic. During the year, we made significant strides towards completing the integration of the Grupo Biotoscana acquisition, all while strengthening the team and processes and driving strong performance.

As part of our integration activities, we completed the implementation of several key systems including, a global CRM, HR IS and a global pharmacovigilance system. In addition, we implemented ERP for 14 legal entities in 6 countries. We further strengthened Knight’s management team with the addition of a Global VP Commercial, a Global VP Scientific Affairs, a Global VP Legal and Compliance and a Global VP Human Resources and most recently added a VP Manufacturing and Operations, to continue delivering on growth and operational excellence. Our business development team closed the acquisition of Exelon and entered into an exclusive supply and distribution agreement with Incyte. Our regulatory team advanced our portfolio with the approval of Halaven, Lenvima and Rembre in Colombia as well as the approval of Nerlynx, while our commercial team continued to deliver on strong growth of our key brands.

It is thanks to the hard work of our employees that we achieved unprecedented results in 2021 and we are entering 2022 with a stronger platform that is well equipped to continue delivering on further growth and success." said Samira Sakhia, President and Chief Executive Officer of Knight Therapeutics Inc.

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 below for additional details
4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets

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 definitions below for additional details
4 Operating expenses include selling and marketing expenses, general and administrative expenses, research and development expenses, amortization and impairment of intangible assets

Revenues: For the quarter ended December 31, 2021 revenues increased by $3,082 or 6% compared to the same prior year period. On a constant currency basis, revenues increased by $2,951 or 6%. The growth in revenues on a constant currency basis is explained as following:

An increase in revenues of $7,095 driven by the acquisition of Exelon.
An increase in revenues of $1,612 or 13%, from $12,559 to $14,171, driven by the growth of our recently launched products, including Cresemba, Lenvima, Halaven, Nerlynx, Trelstar and certain BGx products.
The increase in revenues in Q4-21 vs. Q4-20 was offset by the buying pattern on certain of our infectious disease’s products. It is estimated that approximately $3,200 to $4,200 of products purchased in Q3-21 was not utilized in that quarter and resulted in lower sales in Q4-21.
For the year ended December 31, 2021 revenues increased by $43,959 or 22% compared to the same prior year period. On a constant currency basis, revenues increased by $48,832 or 26%. The growth in revenues on a constant currency basis is explained as following:

An estimated increase in revenues of approximately $13,500 to $16,300 driven by the increased demand of certain of our infectious diseases products to treat invasive fungal infections associated with COVID-19.
An increase in revenues of $21,187 driven by the acquisition of Exelon
An increase in revenues of $15,135 or 45%, from $33,897 to $49,032 driven by the growth of our recently launched products, including, Cresemba, Lenvima, Halaven, Nerlynx, Trelstar and certain BGx products.
Gross margin: For the quarter and year ended December 31, 2021, gross margin increased from 36% to 48% and from 41% to 47% respectively, compared to the same period in prior year due to a change in product mix, the acquisition of Exelon and related revenues recorded as a net profit transfer, lower inventory provision recorded offset by the re-negotiation of certain license agreements and the depreciation of the LATAM currencies. For the quarter and year ended December 31, 2021, the gross margin would have been 51%, an increase of 3%, from 48% and 50%, an increase of 3%, from 47%, after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: For the quarter ended December 31, 2021, selling and marketing increased by $1,773 or 20% and on a constant currency basis by $1,155 or 13% as compared to the same prior year period, driven by an increase in certain variable costs such as logistics fees and annual incentive compensation as well as an increase in selling and marketing activities related to key promoted products and Exelon.

For the year ended December 31, 2021, selling and marketing expenses increased by $1,632 or 5% and on a constant currency basis by $1,801 or 5% as compared to the prior year. Excluding the non-recurring costs and the allowance for expected credit losses, selling and marketing expenses increased by $5,738 or 19%, from $30,052 to $35,790, due to an increase in certain variable costs such as logistics fees and annual incentive compensation as well as an increase in selling and marketing activities related to key promoted products and Exelon.

General and administrative: For the year ended December 31, 2021, general and administrative expenses decreased by $1,686 or 4% and on a constant currency basis by $1,136 or 3% as compared to the same period in prior year. Excluding the non-recurring costs and acquisition costs including the Unified Tender Offer, general and administrative expenses for the year ended December 31, 2021, increased by $2,953 or 10%, from $30,914 to $33,867, driven by an expense of $1,210 related to the extension of the expiry date of certain stock options and an increase in cost related to the annual incentive compensation.

Amortization of intangible assets: For the quarter and year ended December 31, 2021, amortization of intangible assets increased by $9,051, or 113% and $15,641, or 61% respectively, mainly explained by the amortization of $5,731 and $13,686 related to Exelon, the accelerated amortization of $5,435 related to the discontinuation of certain distribution agreements partially offset by the depreciation of LATAM currencies.

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, 2021, interest income was $2,196 and $7,382, a decrease of 22% or $611 and 48% or $6,940 respectively, compared to the same period in prior year due to a lower average cash and marketable securities balances and loan balance.

Interest expense: For the quarter ended December 31, 2021 interest expense was $1,331, an increase of $1,003 or 306%, compared to the same period in prior year due to higher interest rates.

For the year ended December 31, 2021 interest expense was $3,618, an increase of $220 or 6%, compared to prior year due to a decrease in the average loan balance outstanding largely offset by higher interest rates.

Adjusted EBITDA: For the quarter ended December 31, 2021 adjusted EBITDA increased by $3,925 or 222% and on a constant currency basis by $4,342 or 321% compared to Q4-20. The growth in adjusted EBITDA is driven by an increase in gross margin of $6,929 on a constant currency basis offset by an increase in operating expenses adjusted for non-recurring expenses.

For the year ended December 31, 2021 adjusted EBITDA increased by $21,168 or 126% and on a constant currency basis by $24,169 or 175% compared to the same prior year period. The growth in adjusted EBITDA is driven by an increase in gross margin of $32,288 on a constant currency basis due to the increase in revenues offset by an increase in operating expenses adjusted for acquisition and transaction costs as well as non-recurring expenses.

Net loss or income: For the quarter ended December 31, 2021, net loss was $8,301 compared to net income of $8,233 for the same period last year. The variance mainly resulted from the above-mentioned items and (1) an income tax recovery of $6,123 in the fourth quarter of 2021 due to the recognition of certain deferred tax assets compared to an income expense of $2,618 in the prior year period as well as (2) a lower net gain on the revaluation of financial assets measured at fair value through profit or loss of $2,300 in the fourth quarter of 2021 versus a net gain of $25,418 in the prior year period mainly due to unrealized losses and gains on revaluation of the strategic fund investments.

For the year ended December 31, 2021, net income was $15,675 compared to net income of $31,760 in prior year. The variance mainly resulted from the above-mentioned items and (1) an income tax recovery of $8,985 in 2021 due to the recognition of certain deferred tax assets compared to a prior year income tax expense of $325 as well as (2) as well as a lower net gain on the revaluation of financial assets measured at fair value through profit or loss of $18,944 in 2021 versus a net gain of $48,060 in prior year mainly due to unrealized losses and gains on revaluation of the strategic fund investments.

Cash, cash equivalents and marketable securities: As at December 31, 2021, Knight had $149,502 in cash, cash equivalents and marketable securities, a decrease of $242,723 or 62% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the acquisition of Exelon, the shares repurchased through NCIB and the repayments of bank loans offset by cash generated from operating activities and our strategic fund investments.

Financial assets: As at December 31, 2021, financial assets were at $192,443, a decrease of $1,512 or 1%, as compared to the prior year, mainly due to an increase of $19,329 due to mark-to-market adjustments offset by decrease of $14,502 due to net distributions in Knight’s fund investments, loan repayments of $2,684 and disposal of equity investments of $2,624 during the period. Given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets.

Bank Loans: As at December 31, 2021, bank loans were at $35,927, a decrease of $15,843 or 31% as compared to the prior period, mainly due to loan repayment of $20,599 and a $4,674 decrease due to depreciation of LATAM currencies, partially offset by proceeds from bank loans of $9,423.

Product Updates

On March 1, 2021 the Company launched Ibsrela for the treatment of IBS-C. The Company entered into an exclusive licensing agreement with Ardelyx to commercialize Ibsrela in Canada in March 2018. Ibsrela is a first-in-class small molecule treatment for IBS-C. Ardelyx received regulatory approval for Ibsrela from the US FDA in September 2019.

On May 26, 2021, the Company entered into an agreement with Novartis to acquire the exclusive rights to manufacture, market and sell Exelon, in Canada and Latin America as well as an exclusive license to use the intellectual property and the Exelon trademark, from Novartis within those territories. Exelon is a prescription product that was first approved in 1997 and is currently registered and sold in approximately 90 countries. Exelon is indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease and Parkinson’s disease.

Knight has entered into a transition service agreement with Novartis until transfer of marketing authorization, on a country-by-country basis during which Knight will receive a net profit transfer. Knight will begin distributing Exelon upon transfer of marketing authorization, on a country-by-country basis. Knight has submitted the transfer of marketing authorizations for Brazil, Colombia, Mexico and Chile. Furthermore, Knight has received the regulatory notification that the marketing authorization for Exelon in Brazil will transfer to its affiliate in June 2022 and expects the marketing authorizations for other territories to start transferring in the second half of 2022.

On September 22, 2021, Knight entered into a definitive agreement with Incyte Biosciences International Sàrl, for the exclusive rights to distribute tafasitamab (sold as Monjuvi in the United States and Minjuvi in Europe) and pemigatinib (Pemazyre) in Latin America. Under the terms of the agreement Knight will be responsible for seeking the necessary regulatory approvals and distributing both products in Latin America. Knight expects to submit tafasitamab in key LATAM countries in 2022 and pemigatinib in 2023.

Knight obtained regulatory approval for Rembre in Colombia, indicated for treatment of chronic myeloid leukemia with positive Philadelphia chromosome (Ph+). The product was launched in Colombia in February 2022.

Knight obtained INVIMA approval for Lenvima in Colombia, the orally available multiple receptor tyrosine kinase inhibitor developed by Eisai, for the treatment of RR-DTC and u-HCC. Knight launched Lenvima in Colombia in February 2022.

Knight obtained INVIMA approval for Halaven injection in Colombia, indicated for the treatment of adult patients with locally advanced or metastatic breast cancer which has continued to spread after at least two previous treatment for advanced cancer. Previous treatment should have included anthracyclines and a taxane in either the adjuvant or metastatic setting, unless these treatments were not suitable. Halaven is also used to treat patients with advanced or metastatic liposarcoma that cannot be surgically removed and who have already been treated with an anthracycline, unless deemed unsuitable. Knight launched Halaven in Colombia in March 2022.

NCIB

On July 12, 2021, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch a NCIB ("2021 NCIB"). Under the terms of the 2021 NCIB, Knight may purchase for cancellation up to 10,267,956 common shares of the Company which represented 10% of its public float as at December 31, 2021. The 2021 NCIB commenced on July 14, 2021 and will end on the earlier of July 13, 2022 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, 2021, the Company purchased 12,321,864 (2020: 5,748,716) common shares at an average price of $5.23 (2020: $6.40) for an aggregate cash consideration of $64,415 (2020: $36,787). Subsequent to 2021, the Company purchased an additional 933,715 common shares at an average purchase price of $5.35 for an aggregate cash consideration of $4,997.

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 2022, Knight expects to generate $260 to $265 million in 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 December 31, 2021
discontinuation of certain distribution agreements
Exelon marketing authorization transfer to Knight in June 2022 in Brazil
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.

1 Revenues excluding the impact of IAS 29 is a non-GAAP measure, refer to the definitions below 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.

On March 24, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC)(OTC PINK:ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a focus on reducing abuse and overdose while providing relief for those with severe pain, reported plans to release fourth quarter and full year 2021 financial results after close of market on Thursday, March 31, 2022 (Press release, Ensysce Biosciences, MAR 24, 2022, View Source [SID1234610949]).

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Corporate Update Conference Call

Management will host a corporate update conference call on Wednesday, April 6, 2022, at 11:00 a.m. Eastern time. The call will conclude with Q&A from participants.

Please dial in at least 10 minutes before the start of the call to ensure timely participation.

A playback of the call will be available through May 6, 2022 on Ensysce’s Investor Relations website at ir.ensysce.com.

On March 23, 2022 Ligand Pharmaceuticals Incorporated (Ligand) (NASDAQ: LGND) reported the signing of a definitive merger agreement with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), providing for the spin-off of OmniAb, Inc. (OmniAb), Ligand’s antibody discovery business, immediately followed by a merger with a newly formed subsidiary of APAC (Press release, Ligand, MAR 23, 2022, View Source [SID1234610727]). The combined company will be led by Ligand’s President, Matt Foehr, and will be renamed "OmniAb, Inc."

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Upon the closing of the transaction, Avista Capital Partners (Avista), APAC’s sponsor and a leading private equity firm focused on the healthcare industry, has agreed to invest up to $115 million in the combined company, and Ligand will contribute $15 million. The combined company will have an initial pre-money equity valuation of $850 million. Immediately prior to the transaction close, Ligand intends to distribute 100% of its ownership of OmniAb to Ligand shareholders in a tax-free distribution. The transaction is expected to close in the second half of 2022.

Ligand’s OmniAb antibody discovery platform provides pharmaceutical industry partners with access to diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of its proprietary transgenic animals including OmniRat, OmniChicken and OmniMouse, which have been genetically modified to generate antibodies with human sequences to facilitate the development of human therapeutic candidates. Over 55 partners currently have access to OmniAb-derived antibodies and more than 250 programs are being actively developed or commercialized. In 2021, nine antibodies derived from the OmniAb platform entered clinical testing and two royalty-bearing antibodies received regulatory approvals.

"In late 2021, Ligand’s Board of Directors decided to separate Ligand into two public companies given the growth prospects and needs of our various proprietary technology platforms, and to unlock value to Ligand’s shareholders," said John Higgins, CEO of Ligand. "We considered multiple ways to pursue a separation with the goals of ensuring a smooth transition of operations, a healthy balance sheet for both OmniAb and Ligand, and strong market sponsorship. As we were preparing for a first-half 2022 direct spin-off of OmniAb to Ligand’s shareholders, as discussed on our recent earnings call, we received an offer from Avista to merge OmniAb with their SPAC. The Avista team is comprised of high-quality healthcare operators and investors with an excellent track record. They have done extensive due diligence and see the potential and value of OmniAb, a highly competitive, leading platform with strong momentum given recent major clinical and regulatory successes. We are very pleased to partner with APAC and its shareholders to take OmniAb to the next level."

"The OmniAb business is positioned for continued growth and success as we provide partners with access to diverse antibody repertoires and cutting-edge high-throughput screening technologies that enable the discovery of next-generation therapeutics," said Mr. Foehr. "Two OmniAb-derived antibodies recently received regulatory approvals in China and a third approval is expected in the United States later this year. Our growing roster of partners and new programs illustrates the value our technology offers. We are excited to join forces with Avista to further build and expand our differentiated capabilities with applicability to a variety of modalities, and to leverage our technical strengths to become the industry’s partner of choice."

David Burgstahler, CEO of APAC, added, "OmniAb’s merger with APAC and its subsequent status as a standalone public company will help propel the company toward a new phase of growth and value creation. The merger will empower OmniAb with access to the capital markets, strong cash reserves, the agility to drive innovation and a superb leadership team. We look forward to partnering with Matt and the entire organization as they continue to differentiate OmniAb as a critical partner in advancing drug discovery and development."

Matt Foehr will lead OmniAb as CEO and will resign from his role as Ligand’s President and COO at closing. Kurt Gustafson has joined the OmniAb management team as CFO, bringing over 25 years of diverse experience in corporate finance and senior management roles in growth-oriented publicly traded biopharmaceutical companies, most recently as CFO of Spectrum Pharmaceuticals. Mr. Gustafson previously served as CFO of Halozyme Therapeutics and held senior finance roles at Amgen.

Transaction Details

The combination of OmniAb and AHPA is structured to guarantee a minimum of $130 million in gross cash to the combined company at the time of closing, and up to $266 million in the event of no redemptions by APAC shareholders. APAC’s shareholders will be eligible to participate in the transaction or to elect redemption of their shares. Avista has agreed to guarantee that Avista and AHPA will provide at least $115 million of gross cash to the combined company through a $15 million PIPE investment and a $100 million facility to backstop potential redemptions. Ligand’s $15 million contribution to OmniAb will be made irrespective of the number of redemptions or the Avista contributions.

Ligand intends to distribute 100% of the equity in OmniAb to Ligand shareholders immediately prior to the business combination with APAC. The transaction will be effected through a "Reverse Morris Trust" transaction pursuant to which OmniAb will be spun-off to Ligand’s shareholders and simultaneously merged as a subsidiary of APAC. The transaction is expected to be tax-free to Ligand and its shareholders for U.S. federal income tax purposes, except for cash received in lieu of fractional shares. Upon the closing of the transaction, Ligand shareholders are expected to own approximately 75% to 84% of the combined company, depending on redemptions, which will be listed on the Nasdaq Global Markets under the ticker symbol "OABI".

The Boards of Directors of both APAC and Ligand have unanimously approved the proposed transaction, which is subject to customary closing conditions, including receipt of required regulatory approvals and receipt of approval from APAC’s shareholders.

Credit Suisse is acting as lead capital markets and financial advisor to OmniAb, Cowen, Stifel, SVB Leerink and Truist Securities are also acting as capital markets and financial advisors to OmniAb, and CJS Securities, Craig-Hallum Capital Group LLC, H.C. Wainwright & Co. and Roth Capital Partners are acting as advisors to OmniAb. Weil, Gotshal & Manges LLP is legal advisor to APAC. Latham & Watkins LLP is legal advisor to Ligand.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by APAC with the Securities and Exchange Commission (SEC) and will be available on the SEC’s website at www.sec.gov.

Technologies

Following the completion of this transaction, OmniAb will consist of the OmniAb discovery platform featuring transgenic animals that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates, as well as the Icagen ion channel technology. Ligand Pharmaceuticals’ platform technologies will consist of the Captisol technology, a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs, and the Pelican Expression Technology, a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production.