As we have previously noted, travel restrictions related to the COVID-19 pandemic have hindered the FDAs ability to complete inspections in China for the toripalimab BLA as well as the FDAs review of other BLA Coherus and our partners, Junshi Biosciences are currently engaged with the agency regarding creative approaches for the completion of the inspection. The last point I would add, Doug, is we are going to make sure that we are in a strong position for the launch of the on-body system in 2023. Thank you. Zacks Equity Research for To conform to this change, the prior period non-GAAP financial information has been recast to include upfront and milestone-based license fee payments. This ratio is Total Debt for the most recent fiscal year divided by Total Shareholder Equity for the same period. Today, you can download 7 Best Stocks for the Next 30 Days. So, we are going to continue to balance those pricing trade-offs. Thank you, Theresa. UDENYCA net revenues were $45 million, a decline from the prior quarter resulting from lower share and lower net price due to increased competition in the pegfilgrastim market. Bye-bye. So, can you just elaborate on the dynamics there? $-263.86. We are reducing our combined SG&A and R&D expense guidance for 2022 from a range of $375 million to $395 million previously to $375 million to $385 million. Yes. Please register 15 minutes early to ensure a timely connection to the call. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Sure, Denny. So while the COVID-19 pandemic has hindered travel, we are encouraged that the situation is improving while there are certain outbreaks that are not in all regions, the quarantine time is decreasing, and were seeing more folks travel to China. We are pleased with the launch of our new revenue growth driver, CIMERLI, which builds on the success we demonstrated with UDENYCA, our first product, that also rapidly overtook a large, first-to-market competitor. As we pointed out with our prepared remarks and we serve the half the other NTTL market Biogen after 1 month contribute the market share, you recall that with UDENYCA we had a large pharma that kind of from 6 months out of us and it took us 4 months to pass them in terms of market share. Thank you. Thanks, Chris. Net revenue, consisting primarily of net sales of UDENYCA, was $45.4 million and $82.5 million during the threemonths ended September 30, 2022 and 2021, respectively, and $165.7 million and $253.2 million during the nine months ended September 30, 2022 and 2021, respectively. Okay. The FDAs approval of CIMERLI during the third quarter was a milestone that opened access to a $50 million tranche of debt through our credit facility with Pharmakon Advisors, which we drew in late September. This complete label has been well received by retinal specialists giving them the confidence that they can safely transition currently treated Lucentis patients to CIMERLI and expect the same clinical outcomes. For the nine months ended September 30, 2022 and 2021, R&D expense was $170.3 million and $312.3 million, respectively. Thanks so much for the questions. REDWOOD CITY, Calif., Aug. 28, 2017 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today reported topline results from the first of three ongoing pharmacokinetic bioequivalence . This is Boland on for Jason Gerberry. Second, we are getting excellent access to prescribers as our sales in key account teams have delivered more than 1,600 CIMERLI presentations to targeted retinal specialists. (1) 2021 payments include license fees of $145.0 million pursuant to the collaboration agreement with Junshi Biosciences paid in the first quarter which was partially offset by a $9.0 million credit related to the fair value of the discount for lack of marketability on the common shares purchased under the stock purchase agreement with Junshi Biosciences in the second quarter. See Forward-Looking Statements described in the section below. But the FDA, as they have indicated from the February ODAC and have stated a single-country data without the applicability to U.S. medical practice does not warrant regulatory flexibility for non-small cell lung cancer. And I think that we are quite certain of that. And thank for the color and the question. So the on-body segment will serve as the next wave of market share growth for the UDENYCA franchise. Yes, thats the floor. And yes, you have got that right. Net Income Including Extraordinary Items represents net income after being adjusted by extraordinary items, such as accounting changes, discontinued operations, extraordinary items, and taxes on extraordinary items. Thank you very much for the question, Ash. November 01, 2022 at 07:30 AM EDT REDWOOD CITY, Calif., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), today announced that its third quarter 2022 financial results will be released after market close on Tuesday, November 8th, 2022. These statements include, but are not limited to, our ability to gain approval for multiple new products and launch them, timing of the end of our decline in revenue and timing of our ability to gain market share for any of our approved products, expectations about revenue growth, projections of expenses and revenue, our future manufacturing capacity and our ability to return to profitability in 2024. And then I guess for my follow-up there, your guidance seems to still exclude the $25 million milestone payment that was your base case that approval is not going to happen in 2022? And we are successfully fulfilling our mission to deliver value to patients by providing. And by reallocating resources from UDENYCA, we were able to achieve this with no incremental increase in total headcount. Please click the links below to download PDF versions of the following documents: For more information, please visit brand.com. And in our first month, our market share was greater than the Biogen biosimilar, which launched in July. COHERUS BIOSCIENCES, INC. (Exact name of registrant as specified in its charter) Delaware: 001-36721; 27-3615821 (State or other jurisdiction (Commission (IRS Employer. 83% of employees would recommend working at Coherus BioSciences to a friend and 84% have a positive outlook for the business. Forward-looking statements provided on the call today are made as of this date and we undertake no duty to update or revise any forward-looking statements. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors and analysts ability to meaningfully compare Coherus results from period to period, and to identify operating trends in Coherus business. Net loss for the first nine months of 2022 was $232.9 million, or $(3.00) per share on a basic and diluted basis, compared to a net loss of $241.4 million, or $(3.22) per share on a basic and diluted basis for the first nine months of 2021. REDWOOD CITY, Calif., July 28, 2022 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS), today announced that its second quarter 2022 financial results will be released after market close on Thursday, August 4 th, 2022.Starting at 5 p.m. These figures are adjusted for non-recurring items. Selling, general and administrative (SG&A) expense was $44.8 million and $39.9 million during the three months ended September 30, 2022 and 2021, respectively, and $144.9 million and $119.7 million during the nine months ended September 30, 2022 and 2021, respectively. This guidance is subject to a number of risks and uncertainties. Today, that discovery is still the heart of the Zacks Rank. So as Denny said, we are very pleased with the uptake receptivity and we will be looking forward to update you guys as the launch progresses forward. The decrease was driven by lower development costs as several clinical studies were completed in 2021 partially offset by higher compensation expense. Non-GAAP net lossfor the third quarter of 2022 was$74.4million, or$(0.96)per share on a basic and diluted basis, compared to non-GAAP net loss of$26.6 million, or$(0.34)per share on a basic and diluted basis for the same period in 2021. This is the current Price divided by Cash Flow Per Share for the most recent fiscal year. They help us to know a little bit about you and how you use our website. Coherus is revising the guidance range of combined 2022 R&D and SG&A expenses from $375 - $395 million to a range of $375 - $385 million. So its important to realize that the CHOICE 01 data in non-small cell lung cancer showed meaningful efficacy irrespective of PD-L1 status. For the nine months ended September 30, 2022 and 2021, R&D expense was $170.3 million and $312.3 million, respectively. Provides administrative and scheduling support to the Senior Vice President, Investor Relations Work cross-functionally throughout the company to partner and assist with projects as needed Participate in other assignments as requested Experience, Education, Training, Traits: BA is preferred Trademarks and trade names of other companies appearing in this press release are, to the knowledge of Coherus, the property of their respective owners. The company generates revenue primarily from the United States. Founded in 2010, Coherus Biosciences is a biosimilar company that develops and commercializes therapeutics for regulated markets. Thanks, Salim. Written by We see this alignment as a source of competitive advantage. COGS for the third quarter and first nine months of 2021 included thewrite-down of $5.2 million of inventory that did not meet Coherus acceptance criteria. Doug, your line is open. See Non-GAAP Financial Measures below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus business. This quarterly report represents an earnings surprise of -81.13%. Coherus Biosciences is funded by 19 investors. This quarter, the companys revenue growth driver, but on path from UDENYCA to CIMERLI, our initial launch trajectory for CIMERLI suggests that we are on pace to deliver at least $100 million in revenue in 2023 from this product. To read this article on Zacks.com click here. Coherus and partner Junshi Biosciences are currently engaged in discussions with the FDA regarding opportunities to complete the inspections. These statements are not guarantees of future performance and are subject to substantial risks and uncertainties that are discussed in our press release that we should say as well as the documents that we file with the SEC, including those in our quarterly report on Form 10-Q for the third quarter that we filed today. Yes. Selling, general and administrative (SG&A) expense was $44.8 million and $39.9 million during the three months ended September 30, 2022 and 2021, respectively, and $144.9 million and $119.7 million during the nine months ended September 30, 2022 and 2021, respectively. Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer and the commercialization of our portfolio of FDA-approved therapeutics. See Forward-Looking Statements described in the section below. Georgi, thank you for standing by, your line is now open. UDENYCA cost of goods sold increased significantly in the third quarter of 2022 to $35.2 million due to the write-down of $26 million of inventory at risk of reaching exploration prior to sale. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors and analysts ability to meaningfully compare Coherus results from period to period, and to identify operating trends in Coherus business. Yes. Maybe starting on CIMERLI, our consultant checks indicate that basically we see like two camps of retinal specialists. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 27% of the 250 plus Zacks industries. A replay of the webcast will be archived at https://investors.coherus.com/. And so switching is very common. Net loss for the third quarter of 2022 was $86.7 million, or $(1.11) per share on a basic and diluted basis, compared to a net loss of $38.5 million, or $(0.49) per share on a basic and diluted basis for the same period in 2021. Another stock from the same industry, Mirum Pharmaceuticals, Inc. (MIRM), has yet to report results for the quarter ended September 2022. Thats I think what we have seen really from the COVID pandemic was the creation of two distinct markets and segments within the pegfilgrastim class. Outsmart the market with Smart Portfolio analytical tools powered by TipRanks. For instance, there are certain manufacturing activities, which we have the opportunity to delay into subsequent years and so we can take advantage of that. So we are very bullish about the trajectory here with CIMERLI and how thats going and the people that Paul has been able to recruit and go forward and provide the education particularly with respect to the label, the interchangeability and so on, which is really key to the biosimilar market conversion. The decrease was primarily due to the $136.0 million upfront license fee paid to Junshi Biosciences in 2021, which was partially offset by the $35.0 million option exercise fee for CHS-006 in the first quarter of 2022. EBIT is computed as Total Revenues for the most recent interim period minus Total Operating Expenses plus Operating Interest Expense for the same period. Thanks so much for the questions. The interchangeability is giving them greater confidence that they can safely switch currently treated Lucentis patients and expect the same outcomes. Great. FY = Fiscal Year. The CHOICE-01 toripalimab non-small cell lung cancer data was recently published in the Journal of Clinical Oncology, a top-tier peer-reviewed journal that is highly respected and widely read by oncologists. Hourly rate can vary widely depending on many important factors, including education, certifications, additional skills, the number of years you . Paul, do you want to talk to Chris a little bit about pricing on-body, how we do things and how we came to? EPS of $0.63 beats by $0.21 | Revenue of $111.68M beats by $4.99M Coherus BioSciences, Inc. ( NASDAQ: CHRS) Q3 2019 Earnings Conference Call November 6, 2019 4:30 PM ET Company Participants. And sometimes we choose not to participate because of the discount rebates that are required. Mizuho Securities Adjusts Price Target on Coherus BioSciences to $28 From $25, Keeps Bu.. UBS Initiates Coverage on Coherus BioSciences With Neutral Rating, $7 Price Target, Weighted-average number of shares used in computing basic and diluted net loss per share, Total liabilities and stockholders equity (deficit), Cash, cash equivalents and restricted cash at beginning of the period, Net cash (used in) provided by operating activities, Purchases of investments in marketable securities, Proceeds from maturities of investments in marketable securities, Upfront and option payments to Junshi Biosciences, Net cash (used in) provided by investing activities, Proceeds from 2027 Term Loans, net of debt discount & issuance costs, Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs, Proceeds from issuance of common stock upon exercise of stock options, Proceeds from purchase under the employee stock purchase plan, Taxes paid related to net share settlement of RSUs, Repayment of 2022 Convertible Notes and premiums, Repayment of 2025 Term Loan, premiums and exit fees, Net cash provided by financing activities, Net increase (decrease) in cash, cash equivalents and restricted cash, Cash, cash equivalents and restricted cash at end of the period, Reconciliation of cash, cash equivalents, and restricted cash, Cash, cash equivalents and restricted cash, Costs related to termination of CHS-2020 development program, GAAP net loss per share, basic and diluted, Non-GAAP net loss per share, basic and diluted, Shares used in computing basic and diluted net loss per share, Chairman, President & Chief Executive Officer. Dennis M. Lanfear President, CEO & Chairman Rosh Dias, MD, MRCP Chief Medical Officer Richard L. Hameister Chief Technical Officer Chris Slavinsky Chief Business and Legal Officer McDavid Stilwell Thank you. The current consensus EPS estimate is -$0.58 on $58.71 million in revenues for the coming quarter and -$2.58 on $237.46 million in revenues for the current fiscal year. Our YUSIMRY strategy is thus well aligned with the formulary decision-makers, payers and PBMs as we both seek to make the adalimumab biosimilar market as large as possible, as quickly as possible. Cash and cash equivalents were $286.8 million as of September 30, 2022, compared to $417.2 million at December 31, 2021. are not guarantees of future performance and are subject to substantial risks and uncertainties that are discussed in our press release that we should say as well as the documents that we file with the SEC, including those in our quarterly report on Form 10-Q for the third quarter that we filed today. Thats just example, but the expense reductions come from across the company, and they are opportunistic. Hi. Contact Data CONTACT: Patrick O'Brien Senior Vice President, Investor Relations Coherus BioSciences, Inc. pobrien@coherus.com +1 (650) 649-3527 Cash Flow is defined as Income After Taxes minus Preferred Dividends and General Partner Distributions plus Depreciation, Depletion and Amortization. The Coherus team includes proven industry veterans with deep expertise in developing and commercializing biopharmaceutical products. And also the rest of the portfolio in aggregate, as you pointed out, we will, of course, update you as time goes on. Coherus is a fully integrated company with competencies in research, development and commercialization. Those who is prescribing is largely dictated by the insurance companies and feel comfortable prescribing a biosimilar and then those who are willing to go through the insurance who to get patients with a product they want to prescribe. Hey, great. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of Coherus competitive position; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus business, the need to schedule inspections in China and the timing of Coherus regulatory filings; the risk of FDA review issues; the risk of Coherus execution of its change in strategy from a focus on biosimilars to a strategy using cash from its portfolio to fund an immuno-oncology franchise; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus drug candidates; and the risks and uncertainties of possible litigation. The company has topped consensus revenue estimates just once over the last four quarters. [Operator Instructions] Our first question comes from Salim Syed with Mizuho. This does conclude the program. Operator? Coherus launched CIMERLI on October 3, 2022. When the symbol you want to add appears, add it to Watchlist by selecting it and pressing Enter/Return. Coherus Biosciences is registered under the ticker NASDAQ:CHRS . Our oncology commercial capabilities have been built to scale with significant overlap between UDENYCA customers and toripalimab targeted prescribers. Paul? Thanks, Denny. So now that reimbursement pathway is underway. Our partner, Junshi, is also making good progress with their TIGIT antibody trial in combination with toripalimab in a dose expansion study in China, exploring complementary tumor types, including non-small cell lung cancer and esophageal carcinoma and we look forward to emerging data sets in the first half of 2023. Paul? Thanks for taking our question. Our strategy is to maximize long-term value of UDENYCA franchise and to optimize the trade-offs between price and share and to maintain a base share that will enable growth with our on-body device launches in 2023. Great. The company is also developing CHS-305, a biosimilar of Avastin. The only additional comments I would make with respect to the payers and YUSIMRY is that I think that we very prudently planned and invested in very large capacity manufacturing. And I think that the conversion of this market to about some of these centers. And then I guess Ill just like lump it in here, if I can. I will let Dr. Lavallee address that. This is the first of four product launches transforming Coherus into a multi-product company. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Similarly, is our new revenue growth driver, and we are now a multi-product company. Coherus BioSciences, Inc. (NASDAQ:CHRS) Q3 2022 Earnings Conference Call November 8, 2022 5:00 PM ET, Marek Ciszewski - Senior Vice President, Investor Relations, Theresa Lavallee - Chief Development Officer, McDavid Stilwell - Chief Financial Officer. Just a quick question, I think I have heard I just wanted to clarify that you said that there was some loss of coverage for UDENYCA in some markets. TIGIT is an important checkpoint and the data of the literature both support that its important to anti-tumor activity. And Paul and his team are actively reviewing the coverage in that context. the complete list of today's Zacks #1 Rank (Strong Buy) stocks here, Free: See Our Top Stock and 4 Runners Up >>, Want the latest recommendations from Zacks Investment Research? Thus far, travel restrictions related to the COVID-19 pandemic have hindered the FDAs ability to complete inspections in China. Thank you, Jean. Coherus Biosciences has acquired InteKrin on Feb 12, 2014. 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