Knight Therapeutics Reports First Quarter 2021 Results

On May 14, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, reported financial results for its first quarter ended March 31, 2021 (Press release, Knight Therapeutics, MAY 14, 2021, View Source [SID1234580047]). All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

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Q1 2021 Highlights

Financials

Revenues were $46,069, an increase of $230 or 1% over prior year.
Gross margin generated of $20,580 or 45% compared to $19,860 or 43% in prior year.
Adjusted EBITDA1 was $5,580, an increase of $2,383 or 75% over prior year.
Interest income generated of $1,998 a decrease of $2,651 or 57% over prior year.
Net income was $3,558 compared to net loss of $9,477 in prior year.
Cash inflow from operations was $17,207 compared to cash outflow of $21,167 in prior year.
Corporate Developments

Promoted Amal Khouri to Chief Business Officer.
Purchased 3,557,340 common shares through a Normal Course Issuer Bid ("NCIB") for an average cost of $18,592.
Products

Launched Ibsrela in Canada for the treatment of Irritable Bowel Syndrome with Constipation ("IBS-C").
Strategic Investments

Disposed of 315,600 common shares of Medexus for total proceeds of $2,624.
Received distributions of $4,336 from strategic fund investments and realized a gain of $3,031.
Key Subsequent Events

Entered into a definitive agreement with Novartis to acquire the exclusive rights to manufacture, market and sell Exelon in Canada and LATAM for an upfront payment of USD 168,000 ($211,2602) and a milestone payment of up to USD 12,000 ($15,0902).
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.
Announced leadership change with Samira Sakhia assuming role of CEO and Jonathan Goodman assuming role of Executive Chairman effective September 1, 2021.
Purchased 512,271 common shares through its NCIB for an aggregate cost of $2,695.
"We are continuing to execute on multiple fronts. I am excited to report that our key launch brands in Latin America, including Cresemba, Halaven, Lenvima, Trelstar and Nerlynx in Canada grew 116% compared to the prior year quarter. We continue to progress on our integration activities and have commenced implementation of our ERP, CRM and HR and learning management systems. On the business development front, we executed on another transformational transaction with the acquisition of Exelon from Novartis for Canada and Latin America, said Samira Sakhia, President and Chief Operating Officer of Knight Therapeutics Inc. "I am humbled and honored to be leading talented Knights in Canada and across Latin America as we continue to execute on our strategy of acquiring, in-licensing and developing innovative medicines and high quality treatments for Latin America and Canada."

1 Adjusted EBITDA is not defined terms under IFRS, refer to the definitions below for additional details.
2Converted to CAD using the closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction

Revenue: For the quarter ended March 31, 2021, revenues increased by $230 or 1% as a result of an increase in sales from new product launches, partially offset by the depreciation in the LATAM currencies. Excluding the impact of hyperinflation and under constant currency, revenues would have increased by $4,123, which is mainly attributable to the launch of Cresemba, Lenvima, Halaven, Nerlynx and certain BGx products as well as Trelstar, which Knight began commercializing in April 2020.

Gross margin: For the quarter ended March 31, 2021, the gross margin increased from 43% to 45% compared to the same period in the prior year due to lower inventory provision and product mix, partially offset by re-negotiation of certain license agreements and the depreciation of the LATAM currencies. The gross margin would have been 47%, an increase of 2%, from 45% after excluding the adjustment of hyperinflation accounting in accordance with IAS 29.

Selling and marketing: The decrease of $2,501 or 25% for the quarter ended March 31, 2021 compared to the same period in the prior year is due to $1,133 of expected credit loss that was recorded in Q1 20 compared to none in Q1 21 and $783 due to the depreciation of the LATAM currencies.

General and administrative: For the quarter ended March 31, 2021, the general and administrative expenses decreased by $1,336 or 16% as compared to the same period in prior year driven by $671 in savings due to restructuring activities and $789 due to the depreciation of the LATAM currencies.

Amortization of intangible assets: For the quarter ended March 31, 2021, amortization of intangible assets decreased by $737, or 12%, mainly explained by the depreciation in the LATAM currencies partially offset by the amortization of intangible assets acquired during 2020.

Interest income: Interest income is the sum of interest income on financial instruments measured at amortized cost and other interest income. For the quarter, interest income was $1,998, a decrease of 57% or $2,651 compared to the same prior year period due to a decrease in interest rates, the average cash and marketable securities balances and a lower average loan balance.

Interest expense: The interest expense relates to interest incurred on bank loans. For the quarter ended March 31, 2021 interest expenses was $660, a decrease of $487 or 42% compared to the same period in the prior year due to decrease in the average loan balance outstanding.

Adjusted EBITDA: For the three-month period ended March 31, 2021, adjusted EBITDA was $5,580, an increase of $2,383 or 75% compared to the same period last year. The variance is explained by the above mentioned increase in gross margin and decrease in operating expenses.

Net income or loss: For the quarter ended March 31, 2021, net income was $3,558 compared to a net loss of $9,477 for the same period last year. The variance mainly resulted from the above-mentioned items as well as a net gain on the revaluation of financial assets measured at fair value through profit or loss of $9,473 in the first quarter of 2021 versus a loss of $6,730 in the prior year period.

Cash, cash equivalents and marketable securities: As at March 31, 2021, Knight had $382,381 in cash, cash equivalents and marketable securities, a decrease of $9,844 or 3% as compared to December 31, 2020. The variance is primarily due to cash outflows related to the shares repurchased through NCIB, the bank loans repaid by Knight offset by cash generated from operating activities.

Financial assets: There is no significant variance for financial assets. However, given the nature of the fund investments there could be significant fluctuations in the fair value of the underlying assets. More specifically, an investment held within Sectoral Asset Management ("Sectoral") fund, Atea Pharmaceutics Inc ("Atea"), announced in October 2020, the closing of its initial public offering at a public offering price of USD 24 per share. The shares held by Sectoral are subject to a 180-day lockup period. As at March 31, 2021, Atea’s share price closed at USD 61.75 compared to USD 41.78 as at December 31, 2020. As at May 12, 2021, Atea’s share price closed at USD 19.74 Should the share price of Atea remain at this level, the Company would record a loss of approximately $15.2M.

Bank Loans: As at March 31, 2021, bank loans were at $38,192, a decrease of $13,578 as compared to the prior period, mainly due to loan repayment of $8,848 and a further decrease of $4,854 due to the foreign exchange revaluation.

Product Updates

On March 1, 2021 the Company launched Ibsrela (tenapenor) 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 April 17, 2020, the Company announced that Ibsrela was approved by Health Canada.

On April 23, 2021, the Company announced that it has entered into a definitive agreement to acquire the exclusive rights to manufacture, market and sell Exelon, indicated for the symptomatic treatment of mild to moderately severe dementia in people with Alzheimer’s disease, in Canada and Latin America ("Territory"). In addition, the Company obtained an exclusive license to use the intellectual property and the Exelon trademark in the Territory. At closing, Knight will pay USD 168,000 ($211,2601) in cash and may pay up to USD 12,000 ($15,0901) upon the achievement of certain conditions. For the year ended December 31, 2020, Exelon sales in the Territory were approximately USD 47,000.

The closing of this transaction is subject to the completion of the anti-trust clearance process in Brazil. In conjunction with closing, Knight will enter into a transition service agreement 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.

NCIB

On July 10, 2020, the Company announced that the Toronto Stock Exchange approved its notice of intention to launch an additional NCIB (‘2020 NCIB"). Under the terms of the 2020 NCIB, Knight may purchase for cancellation up to 10,856,710 common shares of the Company which represented 10% of its public float as at July 6, 2020. The 2020 NCIB commenced on July 14, 2020 and will end on the earlier of July 13, 2021 or when the Company completes its maximum purchases under the 2020 NCIB. Furthermore, Knight entered into an agreement with a broker to facilitate purchases of its common shares under the 2020 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. During the three-month period ended March 31, 2021, the Company purchased 3,557,340 common shares, for an aggregate cash consideration of $18,592, of which $44 remains to be settled as at March 31, 2021. Subsequent to the quarter, the Company purchased an additional 512,271 common shares, for an aggregate cash consideration of $2,695.

1 Converted using the March 31, 2021 closing foreign exchange rate, actual amount in CAD will vary depending on the exchange rate on the close of the transaction.

Conference Call Notice

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

Final Results of Bioavailability Study of Phebra’s Oral Arsenic Capsule for Acute Promyelocytic Leukaemia (APL) Confirm Bioequivalence of Oral and IV Formulations

On May 14, 2021 Australian pharmaceutical group Phebra (‘Company’) reported that congratulates the Australasian Leukaemia and Lymphoma Group (ALLG) on the release of their abstract EP433 at the virtual European Hematology Association (EHA) (Free EHA Whitepaper) 2021 Conference (Press release, Phebra, MAY 14, 2021, View Source [SID1234580036]).

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The abstract builds on the initial bioequivalence data from the first phase of the trial, published at EHA (Free EHA Whitepaper) in June 2019 and reveals the final results from the ALLG APML5 bioavailability study undertaken by the ALLG at hospitals across Australia in 31 patients with previously untreated APL.

The aim of the APML5 study, was to characterise the bioavailability of Phebra’s oral arsenic trioxide (ATO) capsules and intravenous ATO in patients undergoing standard-of-care consolidation therapy by comparing the total arsenic AUC0-24 and Cmax in whole blood and plasma. Estimates of the geometric mean or oral /IV ratios for all pK parameters closely approximate unity confirming bioequivalence of the oral and IV formulations.

Phebra’s extensive knowledge of arsenic formulations and long-standing relationships with Australian healthcare providers led to a collaboration with the ALLG. Phebra provided funding and supplied the oral ATO capsules and IV ATO injection for the ALLG trial.

With its decade-long ongoing manufacture and supply of Phenasen (arsenic trioxide) Injection, from its multi-purpose sterile injectables facility in Sydney, Australia, Phebra was the first pharmaceutical company to pursue and achieve registration of arsenic trioxide injection for the treatment of newly-diagnosed APL patients. APL is a rare subtype of Acute Myeloid Leukaemia (AML), which accounts for only 10% of all AML diagnoses. AML is rare disease diagnosed at a rate of 3.7 per 100,000 of population.[1].

Phebra Chief Executive Officer (CEO) Andre Vlok, said: "We’re excited that the study’s final pK results confirm the bioequivalence of the oral and IV formulations. It demonstrates that Phebra’s novel oral ATO formulation has the real potential to be a viable, new treatment option for blood cancer patients."

Phebra Executive Director of Research, Dr Mal Eutick, added: "This innovative oral arsenic capsule will provide a beneficial treatment option for patients with APL, importantly, reducing the time they need to spend at hospitals undergoing infusions. We congratulate the ALLG and the team of researchers for their collaboration with Phebra on this breakthrough treatment."

The Chief Executive Officer of the ALLG, Delaine Smith, said: "Clinical trials are essential to understand the biology of the disease and to improve the survival and care of patients. The ALLG member network of haematologists collaborate to conduct high quality trials and research projects that create Better Treatments and Better Lives. The oral capsule formulation of ATO can provide a more convenient treatment option and improve the lives of those with APL."

Compugen Reports First Quarter 2021 Results

On May 14, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the first quarter ended March 31, 2021 (Press release, Compugen, MAY 14, 2021, View Source [SID1234580035]).

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"2021 will be an important year of milestones and execution for Compugen," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "During this year we expect to share data readouts for COM701 in monotherapy, dual and triple combination studies, as well as our COM902 monotherapy study. These important readouts will build upon our earlier COM701 clinical data which have shown durable responses, including a confirmed complete response, in a highly refractory patient population in indications unlikely to respond to checkpoint inhibitors. Our data shared to date reinforce our confidence that COM701 is clinically active, and that PVRIG has the potential to act as an important and untapped target in the immune-oncology space."

Dr. Cohen-Dayag continued, "Our strong execution also includes two new studies: the Phase 1b cohort expansion of COM701 with Opdivo to be initiated in the second quarter of 2021 and the Phase 1 COM701 with COM902 dual combination study to be initiated in the second half of this year. With these programs in place, we will have made tremendous strides in creating a clinical program that comprehensively evaluates the roles of DNAM axis members, PVRIG and TIGIT, with the intersecting PD-1 pathway. We will continue to push forward as leaders in the DNAM axis space, advancing our wholly owned PVRIG and TIGIT assets to potentially drive cancer immunotherapy responses in new and expanded patient populations."

Recent and First Quarter 2021 Corporate Highlights

Announced encouraging updated data from COM701 monotherapy and in combination with Opdivo (nivolumab) studies with durable responses, including a complete response, in tumor types typically unresponsive to checkpoint inhibitors
Announced expansion of clinical collaboration agreement with Bristol Myers Squibb with planned Phase 1b cohort expansion study evaluating COM701 with Opdivo in patients with ovarian, breast, endometrial and microsatellite-stable colorectal cancers. The study is on track to be initiated in the second quarter of 2021
Announced the expansion of the Company’s ongoing research collaboration with Johns Hopkins University to explore the underlying biology and mechanism of action of a novel myeloid target for cancer immunotherapy discovered by Compugen
Published peer-reviewed preclinical data in Cancer Immunology, Immunotherapy, which demonstrate the synergistic effect of COM902 with PVRIG and PD-1 blockade. In vitro and in vivo, the reduced Fc receptor engagement of COM902 does not result in T cell depletion. In vitro COM902 enhances human T and NK cell function and enhances anti-tumor lymphocyte responses and inhibits tumor growth in vivo
Published a review on the biology and potential therapeutic relevance of the DNAM-1 axis in Cancer Immunotherapy
Announced upcoming oral presentation of updated data from COM701 Phase 1 monotherapy and combination study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting
Announced upcoming participation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Targets for Cancer Immunotherapy: A Deep Dive Seminar Series. Eran Ophir, Ph.D., Vice President Research and Drug Discovery, Compugen, will participate in a seminar titled "The TIGIT Pathway: A Deep Dive in Cancer Immunotherapy Targets".
Financial Results
R&D expenses for the first quarter ended March 31, 2021, were $7.3 million compared with $4.7 million for the comparable period in 2020. The increase is attributed mostly to drug manufacturing activities and clinical related activities.

General and administrative expenses for the first quarter ended March 31, 2021, were $2.7 million compared with $2.5 million for the comparable period in 2020. The increase is attributed mainly to increased corporate-related expenses.

Net loss for the first quarter ended March 31, 2021 was $9.9 million, or $0.12 per basic and diluted share, compared with a net loss of $7.1 million, or $0.10 per basic and diluted share, in the comparable period of 2020.

As of March 31, 2021, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $119.4 million, compared with approximately $124.4 million as of December 31, 2020. The Company has no debt.

Opdivo is a registered trademark of Bristol Myers Squibb.

Conference Call and Webcast Information
The Company will hold a conference call today, May 13, 2021, at 8:30 AM ET to review its first quarter 2021 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

Veracyte Announces Data Showing Percepta Genomic Atlas Detects Gene Alterations Targeted in Lung Cancer Treatment, Using Diagnostic Biopsy

On May 14, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that new data demonstrating the ability of the Percepta Genomic Atlas to detect alterations that may inform lung cancer treatment decisions for patients from the same small biopsy that was used for diagnosis (Press release, Veracyte, MAY 14, 2021, View Source [SID1234580028]). Study findings presented today at the American Thoracic Society (ATS) 2021 International Conference show that the test accurately detects known lung-cancer gene variants using small biopsy samples, which may help guide treatment with targeted therapies.

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The in-development Percepta Genomic Atlas will provide comprehensive genomic profiling information on cancerous lung nodules, masses or lymph nodes, utilizing small samples from the same biopsy procedure used for diagnosis (i.e., transbronchial needle aspirate biopsies or TBNA). The test uses targeted DNA and whole-transcriptome RNA sequencing to detect alterations in more than 50 genes known to be present in lung cancer. Veracyte plans to launch the test in the second half of 2021 as part of the company’s comprehensive portfolio of genomic tests in lung cancer.

For the analyses presented at the ATS Conference today, researchers evaluated the feasibility of detecting National Comprehensive Cancer Network (NCCN)-recommended gene alterations with the Percepta Genomic Atlas, using samples from 25 patients obtained during initial bronchoscopy procedures. Results show that the in-development test accurately detected the gene variants in these samples with over 95 percent concordance to a reference next-generation sequencing assay.

"Physicians today are often challenged to obtain genomic profiling information on their lung cancer patients’ tumors, due to inadequate tissue, logistical delays and other factors. As a result, patients often do not receive optimal treatment," said Giulia C. Kennedy, Ph.D., Veracyte’s chief scientific officer and chief medical officer. "These findings give us confidence that the Percepta Genomic Atlas will be able to accurately detect gene alterations that may allow patients to be treated with targeted therapies that are available now and that will be available in the future. Importantly, we believe it will be able to provide this critical information near the time of diagnosis, enabling earlier and more appropriate treatment."

The Percepta Genomic Atlas ATS 2021 abstract can be viewed here. The poster presentation is available on demand to ATS conference registrants through July 2.

The Percepta Genomic Atlas will be a key part of Veracyte’s lung cancer portfolio, which aims to transform care at every step of the patient journey. Collectively, the company’s tests are leveraging cutting-edge genomic science and technology to provide answers and insights that enable physicians and patients to make better, faster and more confident care decisions.

Sutro Biopharma to Participate in Upcoming Virtual Investor Conferences

On May 14, 2021 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported that Chief Executive Officer, Bill Newell, will present at two upcoming virtual investor conferences on May 20 and June 2, 2021 (Press release, Sutro Biopharma, MAY 14, 2021, View Source [SID1234580025]).

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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

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Presentation Details
Cowen’s 2nd Annual Virtual Oncology Innovation Summit
Event: Fireside Chat
Date: Thursday, May 20, 2021
Time: 2:40 p.m. ET / 11:40 a.m. PT

Jefferies Healthcare Conference
Event: Company Presentation
Date: Wednesday, June 2, 2021
Time: 4:30 p.m. ET / 1:30 p.m. PT

Live webcasts of each presentation can be accessed through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. Archived replays of the webcasts will be available on the company’s website for approximately 30 days following each live presentation.