Market Newsdesk

Revenue Increases Sequentially to $4.9 million

EBITDA² was $2.7 million or 55% of net revenue 

OAKVILLE, ON, Nov. 12, 2020 /CNW/ – Cipher Pharmaceuticals Inc. (TSX: CPH) (“Cipher” or “the Company“) today announced its financial and operating results for the three and nine months ended September 30, 2020. Unless otherwise noted, all figures are in U.S. dollars.

Q3 2020 Financial Highlights


(All figures in U.S. dollars, compared to Q3 2019 unless otherwise noted)

• Total revenue was $4.9 million compared to $5.8 million
• Total operating expenses excluding impairment of intangible assets decreased 18% to $2.5 million
• Net Income increased to $1.6 million compared to a loss of $2.1 million
• EBITDA² was $2.7 million or 55% of net revenue compared to a loss of $0.4 million
• EPS was $0.06(CDN$0.08) compared to a loss of $0.08

Management Commentary

“The COVID-19 pandemic continued to impact the economy during the third quarter of 2020. Cipher is navigating through this environment while executing on business improvements and cost reductions. Cipher demonstrated strong profitability during the third quarter and sequential growth in revenue despite market conditions that have not fully normalized. Our focus continues to be on driving profitability, strengthening the balance sheet and looking for the right opportunities for growth,” said Mr. Craig Mull, Interim CEO.

“Epuris continued to perform well in the quarter, revenue was $1.8 million compared to $1.9 million in the third quarter of 2019. Epuris finished the quarter with a 41% market share in the Canadian market, up from 40% in the comparative period. Licensing revenue for Absorica was $2.3 million, a decrease of $0.3 million compared to Q3 2019. Absorica’s market share for the three months ended September 30, 2020 was approximately 6% compared to approximately 8% for the three months ended September 30, 2019, according to Symphony. Market share including Sun’s Absorica LD was approximately 7%.” 

“Third quarter results show sequential growth in revenue and strong year over year growth in earnings.  Starting in Q4, we will be ramping up our strategic promotional efforts to drive market share on our core brands. Excluding an impairment charge total operating costs decreased 18% in the third quarter over last year. This optimized cost structure resulted in EBITDA increasing to $2.7 million or 55% of net revenue compared to a loss of $0.4 million last year.  Our focus for the rest of the year will be on continuing strategic promotional marketing efforts in the Canadian market.”

Management Update on Pipeline projects

Tattoo program (“DTR001”) – “In our tattoo program (“DTR001″), the US patent office issued a Notice of Allowance for the US patent application covering Tattoo dermal compositions (topical, transdermal and intradermal).  We have received encouraging results from the proof of concept studies and identified a lead candidate compound.  Planning is currently underway for the next focused preclinical animal study that will incorporate test parameters that could potentially broaden and reinforce the existing IP portfolio.” said Mr. Craig Mull, Interim CEO.

MOB-015 (“Nail fungus”) – “Our development partner, Moberg, has developed a proprietary formulation that can deliver a higher concentration of active drug to the nail bed than competing products on the market. To date, Moberg has conducted two Phase III studies for MOB-015 that have met the primary endpoint.   Although the overall cure rates were low, there was a significant antifungal effect, as demonstrated in the secondary endpoints of the studies where the mycological cure was achieved in 84% of patients, which is unprecedented for a topical treatment and even higher than reported for oral treatments.  Cipher is continuing discussions with Moberg on next steps.”

Alitretinoin – “We also continue to work with our development partner, Galephar, on a number of interesting projects including Alitretinoin, a drug for severe hand eczema, for the U.S. market. Cipher and Galephar are working closely and expect to receive feedback from a recent clinical protocol submission to the FDA.  Cipher continues to evaluate the market potential for this product.”

Q3 2020 Financial Review


(All figures are in U.S. dollars)

Total revenue was $4.9 million for Q3 2020, compared to $5.8 million for the prior year.  The main driver for the $1.0 million decrease in revenue was a decrease in Licensing revenue.

Licensing revenue was $2.9 million for the three months ended September 30, 2020, compared to $3.6 million for the three months ended September 30, 2019. Licensing revenue from Absorica in the U.S. was $2.3 million, up sequentially from $1.8 million but down from $2.6 million for the three months ended September 30, 2019. Absorica ended the quarter with a 6.0% market share, or 7% including Sun’s Absorica LD.  

Product revenue was $2.0 million for Q3 2020, compared to $2.2 million in Q3 2019. Product revenue from Epuris was $1.8 million during the quarter compared to $1.9 million the prior period. According to Symphony, Epuris had a prescription market share of approximately 41% in Canada for the three months ended June 30, 2020, compared to 40% for the three months ended September 30, 2019.

Total operating expenses decreased 61% to $2.5 million for Q3 2020 compared to $6.5 million for Q3 2019. The decrease was primarily driven by a decrease in impairment of intangible assets and restructuring costs.   Excluding an impairment charge total operating costs decreased 18% in the third quarter over last year.

SG&A expense was $1.6 million for Q3 2020, an increase of $0.4 million compared to the prior period. The increase in SG&A was primarily driven by an increase in costs related to legal and consulting spend.

Net income was $1.6 million, or $0.06 per basic and diluted share (CDN$0.08) in Q3 2020, compared to a loss of $2.1 million, or a loss of $0.08 per basic and diluted share, in Q3 2019. EBITDA was $2.7 million or 55% of net revenue for the quarter, compared to a loss of $0.4 million in Q3 2020.  Adjusted EBITDA for Q3 2020 was $2.8 million or 58% of net revenue, compared to $3.7 million in Q3 2019.

The Company generated $5.5 million in cash from operating activities during the nine-month period ended September 30, 2020. As of September 30, 2020, the Company had cash of $4.7 million and $1.7 million drawn on the credit facility.  The Company’s credit facility has been paid off as at October 30, 2020.

Update on normal course issuer bid

 (“

NCIB”) program

As announced in the August 12, 2020 press release, Cipher has purchased for cancellation 30,000 common shares during the quarter ended September 30, 2020 under the NCIB program.

Financial Statements and MD&A

Cipher’s Financial Statements for the third quarter ended September 30, 2020, and Management’s Discussion and Analysis (the “MD&A“) for the three and nine months ended September 30, 2020, are available on the Company’s website at www.cipherpharma.com in the “Investors” section under “Financial Reports” and on SEDAR at www.sedar.com.

Notice of Conference Call

Cipher will hold a conference call on November 13, 2020, at 8:30 a.m. (ET) to discuss its financial results and other corporate developments.

• To access the conference call by telephone, dial (416) 764-8688 or (888) 390-0546 and use conference ID 46246305.
• A live audio webcast will be available at https://produceredition.webcasts.com/starthere.jsp?ei=1397006&tp_key=a8d3b9b5c2 or the Investor Relations section of the Company’s website at http://www.cipherpharma.com.
• Webcast playback will be available until November 20, 2020.

About Cipher Pharmaceuticals Inc.

Cipher Pharmaceuticals (TSX: CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. For more information, visit www.cipherpharma.com.

Forward-Looking Statements


This document includes forward-looking statements within the meaning of applicable securities laws. These forward-looking statements include, among others, statements with respect to our objectives and goals and strategies to achieve those objectives and goals, as well as statements with respect to our beliefs, plans, expectations, anticipations, estimates and intentions and statements relating to the Special Committee’s review of the strategic direction of the Company and its strategic priorities including the anticipated benefits thereof.  The words “may”, “will”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “plan”, “anticipate”, “estimate”, “expect”, “intend”, “forecast”, “objective”, “hope” and “continue” (or the negative thereof), and words and expressions of similar import, are intended to identify forward-looking statements.

By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, which give rise to the possibility that predictions, forecasts, projections and other forward-looking statements will not be achieved. Certain material factors or assumptions are applied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. We caution readers not to place undue reliance on these statements as a number of important factors, many of which are beyond our control, could cause our actual results to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates and intentions expressed in such forward-looking statements. These factors include, but are not limited to, the extent and impact of the coronavirus (COVID-19) outbreak on our business including any impact on our contract manufacturers and other third party service providers, our ability to enter into development, manufacturing and marketing and distribution agreements with other pharmaceutical companies and keep such agreements in effect; our dependency on a limited number of products; our dependency on protection from patents that will expire; integration difficulties and other risks if we acquire or in-license technologies or product candidates; reliance on third parties for the marketing of certain products; the product approval process is highly unpredictable; the timing of completion of clinical trials, regulatory submissions and regulatory approvals; reliance on third parties to manufacture our products and events outside of our control that could adversely impact the ability of our manufacturing partners to supply products to meet our demands; we may be subject to future product liability claims; unexpected product safety or efficacy concerns may arise; we generate license revenue from a limited number of distribution and supply agreements; the pharmaceutical industry is highly competitive; requirements for additional capital to fund future operations; products in Canada may be subject to pricing regulation; dependence on key managerial personnel and external collaborators; no assurance that we will receive regulatory approvals in the U.S., Canada or any other jurisdictions and current uncertainty surrounding health care regulation in the U.S.; certain of our products are subject to regulation as controlled substances; limitations on reimbursement in the healthcare industry; limited reimbursement for products by government authorities and third-party payor policies; products may not be included on list of drugs approved for use in hospitals; hospital customers may make late payments or not make any payments; various laws pertaining to health care fraud and abuse; reliance on the success of strategic investments and partnerships; the publication of negative results of clinical trials; unpredictable development goals and projected time frames; rising insurance costs; ability to enforce covenants not to compete; risks associated with the industry in which we operate; we may be unsuccessful in evaluating material risks involved in completed and future acquisitions; we may be unable to identify, acquire or integrate acquisition targets successfully; legacy risks from operations conducted in the U.S.; inability to meet covenants under our long term debt arrangement; compliance with privacy and security regulation; our policies regarding returns, allowances and chargebacks may reduce revenues; certain current and future regulations could restrict our activities; additional regulatory burden and controls over financial reporting; reliance on third parties to perform certain services; general commercial litigation, class actions, other litigation claims and regulatory actions; the difficulty for shareholders to realize in the United States upon judgments of U.S. courts predicated upon civil liability of the Company and its directors and officers who are not residents of the United States; the potential violation of intellectual property rights of third parties; our efforts to obtain, protect or enforce our patents and other intellectual property rights related to our products; changes in U.S., Canadian or foreign patent laws; litigation in the pharmaceutical industry concerning the manufacture and supply of novel and generic versions of existing drugs; inability to protect our trademarks from infringement; shareholders may be further diluted if we issue securities to raise capital; volatility of our share price; the fact that we have a significant shareholder; we do not currently intend to pay dividends; our operating results may fluctuate significantly; and our debt obligations will have priority over the common shares of the Company in the event of a liquidation, dissolution or winding up.

We caution that the foregoing list of important factors that may affect future results is not exhaustive. When reviewing our forward-looking statements, investors and others should carefully consider the foregoing factors and other uncertainties and potential events. Additional information about factors that may cause actual results to differ materially from expectations, and about material factors or assumptions applied in making forward-looking statements, may be found in the “Risk Factors” section of this MD&A and the Annual Information Form for the year ended December 31, 2019, and elsewhere in our filings with Canadian securities regulators. Except as required by Canadian securities law, we do not undertake to update any forward-looking statements, whether written or oral, that may be made from time to time by us or on our behalf; such statements speak only as of the date made. The forward-looking statements included herein are expressly qualified in their entirety by this cautionary language.

1) 
At the Q3 2020 average exchange rate

2) 
EBITDA is a non-IFRS financial measure.  The term EBITDA (earnings before interest, taxes, depreciation and amortization,) does not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement IFRS measures by providing a further understanding of operations from management’s perspective. The Company defines Adjusted EBITDA as earnings before interest expense, income taxes, depreciation of property and equipment, amortization of intangible assets, loss on debt extinguishment, non-cash share-based compensation, restructuring costs, changes in fair value of derivative financial instruments, impairment of intangible assets and goodwill and foreign exchange gains and losses from the translation of Canadian cash balances.

The following is a summary of how EBITDA and Adjusted EBITDA are calculated:

 

SOURCE Cipher Pharmaceuticals Inc.

LEXINGTON, Ky., Nov. 12, 2020 /PRNewswire/ — Valvoline Inc. (NYSE: VVV) today announced that its board of directors increased the quarterly cash dividend on the company’s common stock by nearly 11 percent to $0.125 per share. The quarterly dividend will be payable on Dec. 15, 2020, to shareholders of record as of the close of business on Nov. 30, 2020.

The board of directors also authorized the company to repurchase up to $100 million of its common stock. The timing and amount of any purchase of shares of common stock will be based on the level of Valvoline’s liquidity, general business and market conditions and other factors, including alternative investment opportunities. The term of the new share repurchase authorization extends through Sept. 30, 2021. The dividend and share repurchase authorization is part of a broader capital allocation framework to deliver value to shareholders by first driving growth in the business, organically and through acquisitions, and then returning excess cash to shareholders through dividends and share repurchases.

About Valvoline™

Valvoline Inc. (NYSE: VVV) is a leading worldwide marketer and supplier of premium branded lubricants and automotive services, with sales in more than 140 countries. Established in 1866, the Company’s heritage spans more than 150 years, during which time it has developed powerful brand recognition across multiple product and service channels. Valvoline ranks as the No. 3 passenger car motor oil brand in the DIY market by volume. It operates and franchises nearly 1,500 quick-lube locations, and it is the No. 2 chain by number of stores in the United States under the Valvoline Instant Oil Change^SM brand and the No. 3 chain by number of stores in Canada under the Valvoline Great Canadian Oil Change brand. It also markets Valvoline lubricants and automotive chemicals, including Valvoline High Mileage with MaxLife technology motor oil for engines over 75,000 miles; Valvoline Advanced Full Synthetic motor oil; Valvoline Premium Blue™ heavy-duty motor oil; Valvoline Multi-Vehicle Automatic Transmission Fluid; and Zerex™ antifreeze. To learn more, visit www.valvoline.com.

™ Trademark, Valvoline or its subsidiaries, registered in various countries
^SM Service mark, Valvoline or its subsidiaries, registered in various countries

FOR FURTHER INFORMATION:

Sean T. Cornett

Sr. Director, Investor Relations
+1 (859) 357-2798
[email protected] 

Michele Gaither Sparks

Sr. Director, Corporate Communications
+1 (859) 221-9699
[email protected]

View original content to download multimedia:http://www.prnewswire.com/news-releases/valvoline-increases-quarterly-dividend-and-announces-100-million-share-repurchase-authorization-301172466.html

SOURCE Valvoline Inc.

OAKVILLE, ON, Nov. 12, 2020 /PRNewswire/ – Algonquin Power & Utilities Corp. (“APUC”) (TSX: AQN) (NYSE: AQN) announced today that the Board of Directors has declared a dividend of U.S. $0.1551 per share on its common shares, payable on January 15, 2021, to the shareholders of record on December 31, 2020, for the period from October 1, 2020 to December 31, 2020.  Shareholders receiving dividends in cash can elect to receive the dividend in Canadian dollars in the amount of C$0.2019.

The common share dividend will be paid in cash or, if a shareholder has enrolled in the shareholder dividend reinvestment plan (the “Plan”), dividends will be reinvested in additional common shares (“Plan Shares”) of APUC as per the Plan.  Plan Shares will be acquired by way of a Treasury Purchase at the average market price as defined in the Plan less a 5% discount.

Pursuant to the Income Tax Act (Canada) and corresponding provincial legislation, APUC hereby notifies its common shareholders that such dividends declared qualify as eligible dividends.

The quarterly dividends payable on common shares are declared in U.S. dollars. Beneficial shareholders (those who hold common shares through a financial intermediary) who are resident in Canada or the United States may request to receive their dividends in either U.S. dollars or the Canadian dollar equivalent by contacting the financial intermediary with whom the common shares are held. Unless the Canadian dollar equivalent is requested, shareholders will receive dividends in U.S. dollars, which, as is often the case, the financial intermediary may convert to Canadian dollars. Registered shareholders receive dividend payments in the currency of residency. Registered shareholders may opt to change the payment currency by contacting AST Trust Company (Canada) at 1-800-387-0825 prior to the record date of the dividend.

The Canadian dollar equivalent of the quarterly dividend is based on the Bank of Canada daily average exchange rate on the day before the declaration date.

About Algonquin Power & Utilities Corp., Liberty Utilities, and Liberty Power

APUC is a diversified international generation, transmission, and distribution utility with approximately $11 billion of total assets. Through its two business groups, Liberty Utilities and Liberty Power, APUC is committed to providing safe, secure, reliable, cost-effective, and sustainable energy and water solutions through its portfolio of electric generation, transmission, and distribution utility investments to over 1 million customer connections, largely in the United States and Canada.  APUC is a global leader in renewable energy through its portfolio of long-term contracted wind, solar, and hydroelectric generating facilities representing over 2 GW of installed capacity and approximately 1.4 GW of incremental renewable energy capacity under construction.

APUC is committed to delivering growth and the pursuit of operational excellence in a sustainable manner through an expanding global pipeline of renewable energy and electric transmission development projects, organic growth within its rate-regulated generation, distribution, and transmission businesses, and the pursuit of accretive acquisitions.

APUC’s common shares, Series A preferred shares, and Series D preferred shares are listed on the Toronto Stock Exchange under the symbols AQN, AQN.PR.A, and AQN.PR.D, respectively. APUC’s common shares, Series 2018-A subordinated notes and Series 2019-A subordinated notes are listed on the New York Stock Exchange under the symbols AQN, AQNA and AQNB, respectively.

Visit APUC at www.algonquinpowerandutilities.com and follow us on Twitter @AQN_Utilities.

View original content:http://www.prnewswire.com/news-releases/algonquin-power–utilities-corp-declares-fourth-quarter-2020-common-share-dividend-of-us-0-1551-c0-2019-301172465.html

SOURCE Algonquin Power & Utilities Corp.

VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ – CRH Medical Corporation (TSX: CRH) (NYSE MKT: CRHM) (“CRH” or the “Company”), today announced financial and operating results for the three months ended September 30, 2020.

Third quarter 2020 highlights:

• Total revenue of $30.3 million, down 0.2% from third quarter 2019
• Anesthesia services revenue of $28.0 million, up 0.1% from third quarter 2019
• Product sales revenue of $2.4 million, down 3.4% from third quarter of 2019
• Anesthesia patient cases of 94,052 increased 6.0% from third quarter 2019
• Adjusted operating EBITDA of $11.8 million, down 9.3% from third quarter 2019
• Adjusted operating shareholder EBITDA of $8.0 million, a decrease of 15.2% from third quarter 2019
• Through the first nine months of 2020, the Company generated $24.8 million in cash from operating activities and $16.1 million in free cash flow
• The Company also completed three acquisitions and one startup joint venture

Tushar Ramani, Chair and Chief Executive Officer of CRH, commented: “Although COVID-19 continued to exert a negative impact upon both of our business segments in the third quarter, we were encouraged by the 125% increase in anesthesia revenue and the 104% increase in O’Regan revenue as compared to Q2 2020. We remain confident in our ability to execute against our key business initiatives in order to extend and augment our growth trajectory.”

Conference Call

CRH will host a conference call to discuss its results on Friday, November 13, 2020, at 8:30 am ET (5:30 am PT). To participate in the conference, please dial 1-888-664-6392, or 1-416-764-8659 and reference confirmation #64836562. An audio replay will be available shortly after the call by dialing 1-888-390-0541 or 1-416-764-8677 and entering access code 836562#. The replay will be available for two weeks after the call.

About CRH Medical Corporation:

CRH Medical Corporation is a North American company focused on providing gastroenterologists throughout the United States with innovative services and products for the treatment of gastrointestinal diseases. In 2014, CRH became a full-service gastroenterology anesthesia company that provides anesthesia services for patients undergoing endoscopic procedures in ambulatory surgical centers. To date, CRH has completed 30 anesthesia acquisitions, and now serves 66 ambulatory surgical centers in 13 states. In addition, CRH owns the CRH O’Regan System, a single-use, disposable, hemorrhoid banding technology that is safe and highly effective in treating all grades of hemorrhoids. CRH distributes the O’Regan System, treatment protocols, operational and marketing expertise as a complete, turnkey package directly to gastroenterology practices, creating meaningful relationships with the gastroenterologists it serves. CRH’s O’Regan System is currently used in all 48 lower US states.

Non-GAAP Measures

This press release makes reference to certain non-GAAP financial measures including adjusted operating EBITDA (in total and broken down as attributable to non-controlling interest and shareholders of the Company) and adjusted operating EBITDA margin as supplemental indicators of its financial and operating performance.  Adjusted operating EBITDA is defined as operating income before interest, taxes, depreciation, amortization, stock based compensation, acquisition related expenses and asset impairment charges. Adjusted operating EBITDA margin is defined as operating earnings before interest, taxes, depreciation, amortization, stock based compensation, acquisition related expenses and asset impairment charges as a percentage of revenue. These non-GAAP measures are not recognized measures under US Generally Accepted Accounting Principles (“US GAAP”) and do not have a standardized meaning prescribed by US GAAP and thus the Company’s definition may be different from and unlikely to be comparable to non-GAAP measures presented by other companies. These measures are provided as additional information to complement US GAAP measures by providing further understanding of the Company’s results of operations from management’s perspective. Accordingly, they should not be considered in isolation nor as a substitute for analyses of the Company’s financial information reported under US GAAP. Management uses non-GAAP measures such as adjusted operating EBITDA and adjusted operating EBITDA margin to provide investors with a supplemental measure of the Company’s operating performance and thus highlight trends in the Company’s core business that may not otherwise be apparent when relying solely on US GAAP financial measures. Management also believes that securities analysts, investors and other interested parties frequently use non-GAAP measures in the evaluation of issuers. In addition, management uses these non-GAAP measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets, and to assess its ability to meet future debt service, capital expenditure, and working capital requirements. A quantitative reconciliation of adjusted operating EBITDA, and operating EBITDA margin to the most directly comparable measures under US GAAP is presented below.

Cautionary Note Regarding Forward-looking Statements

Information included or incorporated by reference in this press release may contain forward-looking statements. This information may involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “plan,” “intend” or “project” or the negative of these words or other variations on these words or comparable terminology. Certain risks underlying our assumptions are highlighted below; if risks materialize, or if assumptions prove otherwise to be untrue, our results will differ from those suggested by our forward looking statements and our results and operations may be negatively affected. Forward looking statements in this press release include statements regarding the Company’s future growth. Actual events or results may differ materially from those discussed in forward-looking statements. There can be no assurance that the forward-looking statements currently contained in this report will in fact occur. The Company bases its forward-looking statements on information currently available to it. The Company disclaims any intent or obligations to update or revise publicly any forward-looking statements whether as a result of new information, estimates or options, future events or results or otherwise, unless required to do so by law.

Forward-looking information reflects current expectations of management regarding future events and operating performance as of the date of this document. Such information involves significant risks and uncertainties, should not be read as guarantees of future performance or results, and will not necessarily be accurate indications of whether or not such results will be achieved. A number of factors could cause actual results to differ materially from the results discussed in forward-looking information, including, without limitation: Our ability to predict developments in the COVID-19 pandemic and its impact to our operations; changes to payment rates or methods of third-party payors, including United States government healthcare programs, changes to the United States laws and regulations that regulate payments for medical services, the failure of payment rates to increase as our costs increase, or changes to our payor mix, could adversely affect our operating margins and revenues; We are subject to decreases in our revenue and profit margin under our fee for service contracts and arrangements, where we bear the risk of changes in volume, payor mix, radiology, anesthesiology, and pathology benefits, and third-party reimbursement rates; We may or may not successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances, and such acquisitions could result in unforeseen operating difficulties and expenditures, or require significant management resources and significant charges; Our senior management has been key to our growth, and we may be adversely affected if we lose any member of our senior management; ASCs or other customers may terminate or choose not to renew their agreements with us; If we are unable to maintain or increase anesthesia procedure volumes at our existing ASCs, the operating margins and profitability of our anesthesia segment could be adversely affected; We may not be able to successfully recruit and retain qualified anesthesia service providers or other independent contractors; We may be unable to enforce the non-competition and other restrictive covenants in our agreements; We operate in an industry that is subject to extensive federal, state, and local regulation, and changes in law and regulatory interpretations; Changes in the medical industry and the economy may affect the Company’s business; Our failure to comply with U.S. federal and state fraud and abuse laws, including anti-kickback laws and other U.S. federal and state anti-referral laws, could have a material, adverse impact on our business; A significant number of our affiliated physicians could leave our affiliated ASCs; Our industry is already competitive and could become more competitive; Unfavorable economic conditions could have an adverse effect on our business; The Company may not be successful in marketing its products and services; Failure to manage third-party service providers may adversely affect our ability to maintain the quality of service that we provide; Congress or states may enact laws restricting the amount out-of-network providers of services can charge and recover for such services; Adverse events related to our product or our services may subject us to risks associated with product liability, medical malpractice or other legal claims, insurance claims, product recalls and other liabilities, which may adversely affect our operations; Our dependence on suppliers could have a material adverse effect on our business, financial condition and results of operations; We may need to raise additional capital to fund future operations; We are subject to various restrictive covenants and events of default under the Credit Facilities; The Affordable Care Act (“ACA”) and potential changes to it may have a significant effect on our business; The Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) and potential changes to it may have a significant effect on our business; Government authorities or other parties may assert that our business practices violate antitrust laws; If regulations or regulatory interpretations change, we may be obligated to re-negotiate agreements of our anesthetists, anesthesiologists or other contractors; Despite current indebtedness levels, we may still be able to incur substantially more debt, which could further exacerbate the risks associated with increased leverage; Failure to timely or accurately bill for services could have a negative impact on our net revenue, bad debt expense and cash flow; If we or some of our suppliers fail to comply with the FDA’s Quality System Regulation and other applicable requirements, our manufacturing or processing operations could be disrupted, our sales and profitability could suffer, and we may become subject to a wide variety of FDA enforcement actions; If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common shares; Our industry is the subject of numerous governmental investigations into marketing and other business practices which could result in the commencement of civil and/or criminal proceedings, substantial fines, penalties, and/or administrative remedies, divert the attention of our management, and have an adverse effect on our financial condition and results of operations; We may write-off intangible assets; If we are unable to manage growth, we may be unable to achieve our expansion strategy; The continuing development of our products and provision of our services depends upon us maintaining strong relationships with physicians; Significant shareholders of the Company could influence our business operations, and sales of our shares by such significant shareholders could influence our share price; We have a legal responsibility to the minority owners of the entities through which we own our anesthesia services business, which may conflict with our interests and prevent us from acting solely in our own best interests; Our common shares may be subject to significant price and volume fluctuations; Unfavorable changes or conditions could occur in the states where our operations are concentrated: We may be subject to a variety of regulatory investigations, claims, lawsuits, and other proceedings; Our anesthesia employees and third-party contractors may not appropriately record or document services that they provide; If we are unable to adequately protect or enforce our intellectual property, our competitive position could be impaired; If there is a change in federal or state laws, rules, regulations, or in interpretations of such federal or state laws, rules or regulations, we may be required to redeem our physician partners’ ownership interests in anesthesia companies under the savings clause in our joint venture operating agreements; Our employees and business partners may not appropriately secure and protect confidential information in their possession; Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions or data corruption could significantly disrupt our operations and adversely affect our business and operating results; If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our share price and trading volume could decline; We may be subject to criminal or civil sanctions if we fail to comply with privacy regulations regarding the protection, use and disclosure of patient information; Evolving regulation of corporate governance and public disclosure may result in additional expenses and continuing uncertainty; Anti-takeover provisions could discourage a third party from making a takeover offer that could be beneficial to our shareholders; We are an “emerging growth company” and a “smaller reporting company,” and any decision on our part to comply only with certain reduced reporting and disclosure requirements applicable to such companies could make our common shares less attractive to investors; We do not intend to pay dividends on our common shares, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the price of our common shares; Tax reform could have a material adverse effect on us; Income tax audits and changes in our effective income tax rate could affect our results of operations; The patent protection for our products may expire before we are able to maximize their commercial value, which may subject us to increased competition and reduce or eliminate our opportunity to generate revenues; and We may face exposure to adverse movements in foreign currency exchange rates.

For a complete discussion of the Company’s business including the assumptions and risks set out above, see the Company’s Form 10-K Annual Report, which is available on EDGAR at www.sec.gov/edgar.shtml or on the Company’s website at www.crhmedcorp.com.

Condensed Consolidated Balance Sheets

(unaudited)

 

Condensed Consolidated Statements of Operations

(unaudited)

 

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

Adjusted EBITDA Reconciliation

(in thousands, unaudited)

 

Adjusted Operating Expense Reconciliation

(in thousands, unaudited)

 

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SOURCE CRH Medical Corporation

OAKVILLE, ON, Nov. 12, 2020 /PRNewswire/ – Algonquin Power & Utilities Corp. (“APUC”) (TSX: AQN) (TSX: AQN.PR.A) (TSX: AQN.PR.D) (NYSE: AQN) announced today that the Board of Directors of APUC has declared the following preferred share dividends:

1. C$0.32263 per Preferred Share, Series A, payable in cash on December 31, 2020 to Preferred Share, Series A holders of record on December 15, 2020, for the period from September 30, 2020 to, but excluding, December 31, 2020.

2. C$0.31819 per Preferred Share, Series D, payable in cash on December 31, 2020 to Preferred Share, Series D holders of record on December 15, 2020, for the period from September 30, 2020 to, but excluding, December 31, 2020.

Pursuant to the Income Tax Act (Canada) and corresponding provincial legislation, APUC hereby notifies its Series A Preferred Shareholders and its Series D Preferred Shareholders that such dividends declared qualify as eligible dividends.

About Algonquin Power & Utilities Corp., Liberty Utilities, and Liberty Power

APUC is a diversified international generation, transmission, and distribution utility with approximately $11 billion of total assets. Through its two business groups, Liberty Utilities and Liberty Power, APUC is committed to providing safe, secure, reliable, cost-effective, and sustainable energy and water solutions through its portfolio of electric generation, transmission, and distribution utility investments to over 1 million customer connections, largely in the United States and Canada.  APUC is a global leader in renewable energy through its portfolio of long-term contracted wind, solar, and hydroelectric generating facilities representing over 2 GW of installed capacity and approximately 1.4 GW of incremental renewable energy capacity under construction.

APUC is committed to delivering growth and the pursuit of operational excellence in a sustainable manner through an expanding global pipeline of renewable energy and electric transmission development projects, organic growth within its rate-regulated generation, distribution, and transmission businesses, and the pursuit of accretive acquisitions.

APUC’s common shares, Series A preferred shares, and Series D preferred shares are listed on the Toronto Stock Exchange under the symbols AQN, AQN.PR.A, and AQN.PR.D, respectively. APUC’s common shares, Series 2018-A subordinated notes and Series 2019-A subordinated notes are listed on the New York Stock Exchange under the symbols AQN, AQNA and AQNB, respectively.

Visit APUC at www.algonquinpowerandutilities.com and follow us on Twitter @AQN_Utilities.

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SOURCE Algonquin Power & Utilities Corp.

(All amounts in CDN$ unless otherwise indicated)

VANCOUVER, BC, Nov. 12, 2020 /PRNewswire/ – Alexco Resource Corp. (NYSE American: AXU) (TSX: AXU) (“Alexco” or the “Company”) today reports financial results for the three month period ended September 30, 2020 (“Q3 2020”) and provides comments on capital development progress at Keno Hill in anticipation of initial silver (“Ag”) concentrate production in Q4 2020. For Q3 2020, Alexco reported an operating loss of $5.4 million (“M”), or $0.04 per share. Aa at September 30, 2020, the Company had $39.8 M in cash and cash equivalents, and net working capital of $38.0 M.

Key Financial Metrics

Q3 2020 Highlights

Corporate

• The Corporation’s cash and cash equivalents as at September 30, 2020 totaled $39.8 M compared to $6.8 M as at December 31, 2019, while net working capital totaled $38.0 M compared to $10.1 M as at December 31, 2019. The Corporation’s restricted cash and deposits as at September 30, 2020 totaled $2.9 M compared to $2.8 M as at December 31, 2019.
• Alexco reported an operating loss of $5.5 M for Q3 2020, compared to a loss of $1.9 M for Q3 2019. The increase in operating loss is primarily a result of an increase in mine site rehabilitation and dewatering work at the Bellekeno mine in preparation for initial ore production in Q4 2020 and expensed refurbishment work at the Keno Hill mill in preparation for mill commissioning in Q4 2020.
• On July 7, 2020 the Corporation completed an equity financing and issued 10,994,000 common shares at a price of $2.73 per share for aggregate gross proceeds of $30 M.
• On August 5, 2020 Alexco entered into an amended and restated agreement with Wheaton with respect to the streaming agreement between the two companies (see press release dated June 24, 2020, entitled “Alexco Moves Forward to Production at Keno Hill”).

Mine Operations and Exploration

• On July 23, 2020, the Company received the final amended and renewed water use license (“WUL”) for the Keno Hill Silver District (“Keno Hill” or the “District”) from the Yukon Water Board. The WUL authorizes Alexco to source and use water, as well as deposit designated waste streams into approved facilities in and around planned production centers at the Bellekeno, Flame & Moth and Bermingham mines, and the mill facility.
• Progress on site-wide capital projects including mill modifications and infrastructure improvements continues to be on pace for completion with mill commissioning and production of silver (“Ag”) concentrate in Q4 2020. A concentrate off-take provider has been selected and agreements are being finalized.
• The Company’s 2020 surface exploration program that commenced on July 17, 2020 has been extended to include a total of approximately 7,500 meters (“m”) core drilling in at least 12 holes, exclusively testing for deeper mineralization in the Bermingham mine area. Drilling will continue until late November.

Clynt Nauman, Alexco’s Chairman and Chief Executive Officer, commented, “During the third quarter we made significant progress at Keno Hill. I am pleased to report that we are already placing ore from the Bellekeno mine on the coarse ore pad in anticipation of mill commissioning in the very near future. Separately, underground development at the Flame & Moth and Bermingham mines continues to advance and remain on track to provide development ore in Q1 2021. Upgrades to surface infrastructure and the District Mill are nearing completion, and mill circuits have been successfully wet-tested. We are continuing with our mine optimization studies with respect to underground development efficiencies and improved NSR values for ore both within the PFS mine plan as well as adjacent mineralization. We expect to complete and report on this work in the first half of 2021.” Mr. Nauman continued, “Our exploration program at the Bermingham ‘deep’ target will be wrapping up this month and we look forward to sharing the results when they become available”.

Capital Development and Operations

On June 24, 2020, the Company announced that it is moving forward to finalize development of its mines at Keno Hill, with a goal of mill commissioning and Ag concentrate production in Q4 2020. The Company is making steady progress towards its initial production goal with mine site development activities, recruitment of key personnel, delivery of mine equipment, refurbishment of the mill, and completion of surface infrastructure projects continuing into Q4 2020.

In the mill, installation of cyclones, the addition of a new tailings filter press and modification to the fine ore feeder is complete. Other mill improvement projects underway include installation of a second ball mill, construction of a crusher enclosure and ventilation system and installation of two concentrate regrind mills. Other surface construction activities nearing final completion include the expansion of the camp accommodation complex including two new bunkhouse units, an upgraded administration complex, and employee dry and wash facilities.

Underground refurbishment projects at the Flame & Moth and Bermingham mines are complete and primary ramp development continues at both mines. Delivery and commissioning of the major pieces of new underground mine equipment is largely complete. The new fleet includes four (4) CAT R1300 3.5 yard scoops, two (2) CAT AD22 20 tonne haul trucks, two (2) Atlas Copco 282 twin boom jumbos, two (2) MacLean SSB bolters and other support gear. Development and long-hole extraction of ore from two underground levels continues at the Bellekeno mine with ore from these activities being delivered to the mill coarse ore pad. At the Flame & Moth mine, advance of the primary ramp is continuing with approximately 140 m of primary ramp required to reach the first level access point on the 835 level followed by 100 m of level access to cross cut the ore. At the Bermingham mine, development of the vent raise access level is underway prior to mobilization of the contract raise development crew within the next month.

Elsewhere, the Company continues to successfully recruit and onboard the mine operations team. Key managers, site supervisors and mine engineering staff are all in place and the current focus continues to be the onboarding of geologists, underground miners, and maintenance specialists. The current head count at Keno Hill is approximately 125 employees. Over 90% of the Alexco employees currently hired are from the Yukon and British Columbia including citizens of the First Nation of Na-Cho Nyak Dun.

With the significant increase in underground and district-wide operating activities at Keno Hill, the safety performance of all employees and contractors remains excellent and exemplifies the culture of safety excellence instilled at Keno Hill. The Company’s safety record has now exceeded over 7.5 years without a Lost Time Accident.

The Company’s strict COVID-19 management protocols and operating practices remain in place and are continuously reviewed to comply with the guidelines of the Yukon Chief Medical Officer.

Financial
 Report

Full details of the financial and operating results for Q3 2020 are described in Alexco’s interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2020 with accompanying notes and related management’s discussion and analysis. These documents and additional information about Alexco, including its annual information form, are available on Alexco’s website at www.alexcoresource.com and on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.shtml.

Conference Call for Q3 2020 Results

Alexco is hosting an audio webcast conference call to discuss these results at 11:00 a.m. Eastern (8:00 am Pacific) on Friday, November 13, 2020. To participate in the live call, please use one of the following methods:

Qualified Persons

The disclosure in this news release of scientific and technical information regarding exploration projects on Alexco’s mineral properties has been reviewed and approved by Alan McOnie, FAusIMM, Vice President, Exploration, while that regarding mine development and operations has been reviewed and approved by Neil Chambers, P.Eng., Chief Mine Engineer, both of whom are Qualified Persons as defined by National Instrument 43-101 – Standards of Disclosure for Mineral Projects (“NI 43-101”).

About Alexco                                                                       

Alexco is a Canadian primary silver company that owns and operates the majority of the historic Keno Hill Silver District, in Canada’sYukon Territory, one of the highest-grade silver deposits in the world. Alexco is currently advancing Keno Hill to production and expects to start concentrate production and shipments in Q4 2020. As per Alexco’s 2020 pre-feasibility study, Keno Hill is expected to produce an average of approximately 4 million ounces of silver per year contained in high quality lead/silver and zinc concentrates. Total production over an 8-year mine life is estimated at 1.18 million tonnes of ore at an average rate of 430 tonnes per day at an average grade of 805 grams per tonne. Keno Hill retains significant potential to grow and Alexco has a long history of expanding the operation’s Mineral Resources through successful exploration.

Some statements (“forward-looking statements”) in this news release contain forward-looking information plans related to Alexco’s business and other matters that may occur in the future, made as of the date of this news release. Forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other factors which could cause actual events or results to differ from those expressed or implied by the forward-looking statements. Such factors include, among others, risks related to risks and uncertainties relating to the COVID-19 pandemic including but not limited to business closures, travel restrictions,  quarantines and a general reduction in consumer activity; actual results and timing of exploration and development, mining, environmental services and remediation and reclamation activities; future prices of silver, gold, lead, zinc and other commodities; possible variations in mineral resources, grade or recovery rates; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the mining industry; First Nation rights and title; continued capitalization and commercial viability; global economic conditions; competition; and delays in obtaining governmental approvals or financing or in the completion of development activities. Forward-looking statements are based on certain assumptions that management believes are reasonable at the time they are made. In making the forward-looking statements included in this news release, Alexco has applied several material assumptions, including, but not limited to the circumstances surrounding the COVID-19 pandemic, although evolving, will stabilize or at least not worsen; that the extent to which COVID-19 may impact the Company, including without limitation disruptions to the mobility of Company personnel, costs associated with implementation of health and safety protocols, increased labour and transportation costs, and other related impacts, will not change in a materially adverse manner; Alexco will be able to raise additional capital as necessary, that the proposed exploration and development activities will proceed as planned, and that market fundamentals will result in sustained silver, gold, lead and zinc demand and prices. There can be no assurance that forward-looking statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Alexco expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise, except as otherwise required by applicable securities legislation.

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SOURCE Alexco Resource Corp.

SAN FRANCISCO and AUSTIN, Texas, Nov. 12, 2020 /PRNewswire/ — Digital Realty (NYSE: DLR), a leading global provider of carrier- and cloud-neutral data center, colocation and interconnection solutions, along with Vapor IO, creators of the Kinetic Edge^® platform, the first fully-integrated hardware and software platform for edge colocation, exchange and networking services, and Hivelocity, a leading provider of global bare metal cloud services, announced today the availability for developers to deploy core-to-edge workloads on Hivelocity’s bare metal edge cloud, first in Atlanta, but soon in other cities nationwide.

The multi-tier edge deployment in Atlanta builds upon Digital Realty and Vapor IO’s announcement in June, highlighting the integration of Vapor IO’s Kinetic Edge architecture with Digital Realty’s Network Hub Solution on PlatformDIGITAL^®.  Hivelocity, a Digital Realty customer, was able to quickly extend its bare metal cloud to Vapor IO’s Kinetic Edge locations due to integration work already completed by Vapor IO and Digital Realty.

“Leveraging the joint solution available through Vapor IO’s Kinetic Edge and Digital Realty’s PlatformDIGITAL, we were able to lower costs and get to market quicker,” said Steve Eschweiler, COO of Hivelocity.  “By using our existing control plane in Digital Realty’s facilities to orchestrate machines in Vapor IO’s data centers at the infrastructure edge, leveraging the integrated Digital Realty Service Exchange and Kinetic Edge Exchange networks for connectivity, we were able to quickly and cost-effectively extend our bare metal cloud to the infrastructure edge, where last-mile telco networks are aggregated.” 

Separately, Hivelocity also
announced
today it has selected Vapor IO’s Kinetic Edge platform nationwide and will bring its bare metal edge cloud to the 36 U.S. cities where Vapor IO is actively deploying.

The collaboration between Vapor IO and Digital Realty combines the cloud proximity, core, regional edge, local edge and interconnection capabilities of PlatformDIGITAL^® with the last–mile, low-latency, distributed architecture of the Kinetic Edge network.  This combination offers companies like Hivelocity a seamless platform for delivering core-to-edge capabilities that are the basis for many emerging edge use cases.

“We designed this joint solution to combine the data center and networking infrastructure needed to enable cloud-to-core-to-edge applications,” said Cole Crawford, founder and CEO at Vapor IO. “Hivelocity’s ability to simply and effectively extend its bare metal cloud to the edge in Atlanta is a perfect example of how we’re making it easier for joint customers to deliver low-latency edge services that tie back to their regional and core workloads.”  

For example, using Hivelocity’s bare metal cloud, a developer can deploy a multi-tier AI-based application, running low-latency inferencing in Vapor IO edge locations while training sophisticated AI models in Digital Realty’s regional edge and core facilities.

“The combination of Vapor’s Kinetic Edge and Digital Realty’s PlatformDIGITAL^® is a crucial building-block for core-to-edge workloads, which we are actively supporting in Atlanta, Chicago and Dallas,” said Digital Realty Chief Technology Officer Chris Sharp. “Hivelocity’s ability to tap into this service and create a clear path to highly interconnected true core-to-edge infrastructure for their customers is precisely the simplicity we hope to provide.”  

Additional Resources:

• Blog:  Bringing Interconnection to the Edge
• Learn more about Digital Realty’s Network Hub solution
• The latest megatrend and its effect on Global 2000 enterprises: Data Gravity

About Digital Realty


Digital Realty supports the world’s leading enterprises and service providers by delivering the full spectrum of data center, colocation and interconnection solutions. PlatformDIGITAL^®, the company’s global data center platform, provides customers a trusted foundation and proven Pervasive Datacenter Architecture PDx™ solution methodology for scaling digital business and efficiently managing data gravity challenges.  Digital Realty’s global data center footprint gives customers access to the connected communities that matter to them with more than 280 facilities in 49 metros across 24 countries on six continents.  To learn more about Digital Realty, please visit digitalrealty.com or follow us on LinkedIn and Twitter.   

About Vapor IO

Vapor IO is developing the largest nationwide edge networking, colocation and exchange platform at the edge of the wireless and wireline networks. Serving the world’s largest carriers, operators, cloud providers, web-scale companies and other innovative enterprises, the company’s Kinetic Edge® platform combines multi-tenant colocation with software-defined interconnection and high-speed networking. The Kinetic Edge platform offers the most flexible, highly-distributed infrastructure for delivering modern, low-latency applications, and the company has deployed its Kinetic Edge in Chicago, Atlanta, Dallas, and Pittsburgh, furthering its goal to deploy over 100 data centers in 36 U.S. markets over the next two years.¹Follow @VaporIO on Twitter.

About Hivelocity

Hivelocity is a leading provider of global IaaS and Edge Computing services. With a total of 32 data centers in 26 cities across four continents, Hivelocity has created one of the most geographically diverse and comprehensive edge computing platforms and infrastructures in the world. Hivelocity enables its customers to instantly deploy bare-metal servers across any of its data centers with ease. By leveraging the Hivelocity platform, users can easily manage and scale their edge computing solutions when desired.

¹ Vapor, Kinetic Edge and Kinetic Edge Exchange are trademarks of Vapor IO, all rights reserved.

Media & Industry Analyst Relations

Marc Musgrove

Digital Realty
+1 (415) 508-2812
[email protected]

Jessica Gomez-Rees

For Vapor IO
+1 (415) 889-7444
[email protected]

Investor Relations

John Stewart

Digital Realty
+1 (415) 738-6500
[email protected]

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SOURCE Digital Realty

NEWTON, Mass., Nov. 12, 2020 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the results of the Phase 3 BOSTON (Bortezomib, Selinexor and Dexamethasone) study evaluating XPOVIO in patients with relapsed or refractory multiple myeloma were published online in The Lancet. The BOSTON study evaluated once weekly XPOVIO, the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with once weekly Velcade® (bortezomib) and low-dose dexamethasone against standard twice weekly Velcade in adult patients with multiple myeloma who had received one to three prior lines of therapy.

“The results from the BOSTON study published in The Lancet demonstrate that the once-weekly regimen of XPOVIO and Velcade®, with low-dose dexamethasone (SVd) reduced the risk of disease progression or death by 30% and induced a higher rate of overall and deep responses compared to patients receiving a standard twice-weekly Velcade® and low-dose dexamethasone regimen (Vd). This was observed despite  approximately 40% less Velcade®, 25% less dexamethasone and approximately 35% fewer clinic visits on the SVd arm as compared with the standard Vd therapy arm.  Encouragingly, the efficacy of the SVd regimen was consistent and noteworthy across several key subgroups, including patients who were frail or 65 years and older, patients with high-risk cytogenetics, patients with moderate renal impairment and patients who had either prior bortezomib or lenalidomide treatment,” said Dr. Paul Richardson, MD, Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and co-senior author of the manuscript.  

“Despite the enrollment of 50% of patients with high risk cytogenetics, a particularly difficult to treat population, the SVd regimen demonstrated a 47% improvement in progression-free survival as compared to the Vd regimen and an overall response rate of 76.4%. Additionally, the rate and severity of peripheral neuropathy, a key treatment-limiting side effect commonly seen with Velcade® therapy, was significantly lower on the SVd arm compared to the Vd arm and may lead to improved patient quality of life,” said Sundar Jagannath, MD, Director of the Center of Excellence for Multiple Myeloma and Professor of Medicine, Hematology and Medical Oncology, at the Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, and an investigator in the BOSTON study.

“We are honored to have the Phase 3 BOSTON data selected for publication in such a highly esteemed medical journal and to be shared with the global oncology community,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “We believe the successful outcome of this study represents an important advancement for myeloma patients and we are sincerely grateful to all of the patients and investigators who participated in the BOSTON study. While XPOVIO received accelerated FDA approval last year for patients with penta-refractory multiple myeloma, a supplemental New Drug Application requesting approval for XPOVIO as a treatment for patients with multiple myeloma who have received one prior line of therapy has been accepted by the FDA and assigned a PDUFA action date of March 19, 2021.  We are working closely with the regulatory authorities in both the U.S. and Europe to make this potential new treatment option, with a completely novel mechanism of action, available to patients as quickly as possible, if approved.”

Once-weekly SVd is a novel, effective and convenient triplet therapy that utilizes approximately 40% less Velcade® and 25% less dexamethasone and requires approximately 35% fewer clinic visits during the first 24 weeks of treatment compared to the standard Vd regimen. Because Velcade® is given as a subcutaneous injection rather than as an infusion, clinic visits may be shorter with the SVd regimen than with other non-Velcade® regimens that may be employed to treat relapsed multiple myeloma and require intravenous infusions.

The Phase 3 BOSTON Study Results as Published in the Lancet

The published BOSTON study results are based on the multi-center, Phase 3, randomized study (NCT03110562), which evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly selinexor in combination with once-weekly Velcade® (bortezomib) plus low-dose dexamethasone (SVd) versus twice-weekly Velcade® plus low-dose dexamethasone (Vd). The primary endpoint of the study was progression-free survival (PFS) and key secondary endpoints included overall response rate (ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON study allowed for patients on the Vd control arm to crossover to the SVd arm following objective (quantitative) progression of disease verified by an Independent Review Committee (IRC). The BOSTON study was conducted at over 150 clinical sites internationally.

Although the study had one of the highest proportions of patients with high-risk cytogenetics (~50%) as compared with other Velcade-based studies in previously treated myeloma, the median PFS in the SVd arm was 13.93 months compared to 9.46 months in the Vd arm, representing a 4.47 month (47%) increase in median PFS (hazard ratio[HR]=0.70; p=0.0075). The SVd group also demonstrated a significantly greater ORR compared to the Vd group (76.4% vs. 62.3%, p=0.0012). Patients who had received only one prior line of therapy also demonstrated a higher ORR on the SVd arm as compared to the Vd arm (80.8% vs. 65.7%, p=0.0082). Importantly, SVd therapy compared to Vd therapy showed consistent PFS benefit and higher ORR across several important subgroups.

In addition, the following results favored SVd therapy as compared to Vd therapy:

SVd therapy demonstrated a significantly higher rate of deep responses, defined as ≥ Very Good Partial Response compared to Vd therapy (44.6% vs. 32.4%) as well as a longer median duration of response (20.3 months vs. 12.9 months). Additionally, 16.9% of patients on the SVd arm achieved a Complete Response or a Stringent Complete Response as compared to 10.6% of patients receiving Vd therapy.  All responses were confirmed by an IRC.

Data at the time of analysis showed a trend toward an overall survival (OS) benefit associated with SVd therapy with fewer deaths, numerically, reported on the SVd arm (47 vs. 62). Median OS for the SVd arm had not yet been reached as of the data cut-off date of February 18, 2020, while the median OS for the Vd arm was 25.0 months. The median OS for the SVd arm will be reported once it is reached and becomes available.

Peripheral neuropathy (PN) rates were significantly lower on SVd compared to Vd (32.3% vs. 47.1%; p=0.0010). In addition, PN rates of grade ≥2 were also significantly lower in the SVd arm compared to Vd (21.0% vs. 34.3%, P=0.0013).

The most common treatment-emergent adverse events (AEs) were cytopenias, along with gastrointestinal and constitutional symptoms and were consistent with those previously reported from other selinexor studies. Most AEs were manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea (50%), fatigue (42%), decreased appetite (35%), and diarrhea (32%) and were mostly Grade 1 and 2 events. The most common Grade 3 and 4 treatment-related AEs were thrombocytopenia (39%), anemia (16%), and fatigue (13%).

About Multiple Myeloma

According to the National Cancer Institute (NCI), multiple myeloma is one of the most common types of blood cancer in the U.S. with more than 32,000 new cases each year and over 140,000 patients living with the disease. It is most frequently diagnosed among people aged 65-74 years old. Despite recent therapeutic advances, there is currently no cure and most patients’ disease will typically progress following treatment with currently available therapies. According to the NCI, nearly 13,000 deaths due to multiple myeloma are expected in the U.S. in 2020.

About XPOVIO® (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm’s supplemental New Drug Application (sNDA) requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy has been accepted for filing by the FDA. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

IMPORTANT SAFETY INFORMATION

Thrombocytopenia: XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia was reported in patients with multiple myeloma (MM) and developed or worsened in patients with DLBCL.

Thrombocytopenia is the leading cause of dosage modifications. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia: XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection. Neutropenia and febrile neutropenia occurred in patients with MM and in patients with DLBCL.

Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction (AR).

Gastrointestinal Toxicity: XPOVIO can cause severe gastrointestinal toxicities in patients with MM and DLBCL.

Nausea/Vomiting: Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated.

Diarrhea: Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration, and replace electrolytes as clinically indicated.

Anorexia/Weight Loss: Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first 3 months of treatment. Interrupt, reduce dose, or permanently discontinue based on severity of ARs. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated.

Hyponatremia: XPOVIO can cause severe or life-threatening hyponatremia. Hyponatremia developed in patients with MM and in patients with DLBCL.

Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first 2 months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose, or permanently discontinue based on severity of the AR.

Serious Infection: XPOVIO can cause serious and fatal infections. Most infections were not associated with Grade 3 or higher neutropenia. Atypical infections reported after taking XPOVIO include, but are not limited to, fungal pneumonia and herpesvirus infection.

Monitor for signs and symptoms of infection, and evaluate and treat promptly.

Neurological Toxicity: XPOVIO can cause life-threatening neurological toxicities.

Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity.

Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate.  

Embryo-Fetal Toxicity: XPOVIO can cause fetal harm when administered to a pregnant woman.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS

The most common adverse reactions in ≥20% of patients with MM are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The most common ARs, excluding laboratory abnormalities, in ≥20% of patients with DLBCL are fatigue, nausea, diarrhea, appetite decrease, weight decrease, constipation, vomiting, and pyrexia. Grade 3-4 laboratory abnormalities in ≥15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in ≥5% were thrombocytopenia, lymphopenia, and neutropenia.

In patients with MM, fatal ARs occurred in 9% of patients. Serious ARs occurred in 58% of patients. Treatment discontinuation rate due to ARs was 27%. The most frequent ARs requiring permanent discontinuation in ≥4% of patients included fatigue, nausea, and thrombocytopenia.

In patients with DLBCL, fatal ARs occurred in 3.7% of patients within 30 days, and 5% of patients within 60 days of last treatment; the most frequent fatal AR was infection (4.5% of patients). Serious ARs occurred in 46% of patients; the most frequent serious AR was infection.  Discontinuation due to ARs occurred in 17% of patients.

USE IN SPECIFIC POPULATIONS

In MM, no overall difference in effectiveness of XPOVIO was observed in patients >65 years old when compared with younger patients. Patients ≥75 years old had a higher incidence of discontinuation due to an AR than younger patients, a higher incidence of serious ARs, and a higher incidence of fatal ARs.

Clinical studies in patients with relapsed or refractory DLBCL did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

The effect of end-stage renal disease (CL_CR <15 mL/min) or hemodialysis on XPOVIO pharmacokinetics is unknown.

Please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

.

About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm’s Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm’s lead compound, XPOVIO® (selinexor), received accelerated approval from the U.S. Food and Drug Administration (FDA) in July 2019 in combination with dexamethasone as a treatment for patients with heavily pretreated multiple myeloma. In June 2020, XPOVIO was approved by the FDA as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for selinexor for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding Karyopharm’s expectations and plans relating to XPOVIO for the treatment of patients with relapsed or refractory multiple myeloma or relapsed or refractory diffuse large B-cell lymphoma; commercialization of XPOVIO or any of its drug candidates and the commercial performance of XPOVIO; submissions to, and the review and potential approval of selinexor by, regulatory authorities, including the Company’s regulatory strategy, the anticipated availability of data to support such submissions, timing of such submissions and actions by regulatory authorities and the potential availability of accelerated approval pathways; the expected design of the Company’s clinical trials; the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, especially selinexor. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond Karyopharm’s control, that may cause actual events or results to differ materially from Karyopharm’s current expectations. For example, there can be no guarantee that Karyopharm will successfully commercialize XPOVIO; that regulators will agree that selinexor qualifies for conditional approval in the E.U. as a result of data from the STORM study or confirmatory approval in the U.S. or E.U. based on the BOSTON study in patients with multiple myeloma or that any of Karyopharm’s drug candidates, including selinexor, will successfully complete necessary clinical development phases or that development of any of Karyopharm’s drug candidates will continue. Further, there can be no guarantee that any positive developments in the development or commercialization of Karyopharm’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: the risk that the COVID-19 pandemic could disrupt Karyopharm’s business more severely than it currently anticipates, including by negatively impacting sales of XPOVIO, interrupting or delaying research and development efforts, impacting the ability to procure sufficient supply for the development and commercialization of selinexor or other product candidates, delaying ongoing or planned clinical trials, impeding the execution of business plans, planned regulatory milestones and timelines, or inconveniencing patients; the adoption of XPOVIO in the commercial marketplace, the timing and costs involved in commercializing XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; the ability to retain regulatory approval of XPOVIO or any of Karyopharm’s drug candidates that receive regulatory approval; Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; the ability of Karyopharm or its third party collaborators or successors in interest to fully perform their respective obligations under the applicable agreement and the potential future financial implications of such agreement; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm’s competitors for indications in which Karyopharm is currently developing its drug candidates; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which was filed with the Securities and Exchange Commission (SEC) on November 2,, 2020, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Velcade® is a registered trademark of Takeda Pharmaceutical Company Limited.

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SOURCE Karyopharm Therapeutics Inc.