Coherus BioSciences eine (Seite 33)

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Denny Lanfear gründete Coherus BioSciences mit einem Team von Industrieveteranen, um die Möglichkeiten von
Biosimilars, ermöglicht durch den Biologics Price Competition and Innovations Act (BPCI Act). Biosimilars
sind für die Verwendung anstelle von bestehenden Marken-Biologika zur Behandlung einer Reihe von oft lebensbedrohlichen Erkrankungen gedacht, mit
das Potenzial, Kosten zu senken und den Patientenzugang zu erweitern. Coherus hat eine Reihe von Biosimilars in Entwicklung. Ein G-CSF
Biosimilar ist das am weitesten fortgeschrittene, mit einer von der US - amerikanischen Food and Drug Administration (FDA) akzeptierten Anwendung für
Rezension. Das FDA-Aktionstermin ist für Anfang November 2018 geplant.
Warum sind Biosimilars für das US-Gesundheitssystem wichtig?
Onkologen in der Gemeinschaft sind sich der steuerlichen Belastungen des US-Gesundheitssystems bewusst. Zum Beispiel nehmen Sie eine Alterung
Bevölkerung mit Zugang zu therapeutischen Fortschritten, die es ihnen ermöglichen, länger zu leben, und dies mit dem Individuum und zu verbinden
kumulative Kosten dieser Innovationen, und die Auswirkungen sind atemberaubend. Innovation in der Onkologie, insbesondere Biologika,
Seit den frühen 1990er Jahren bietet Gesundheitsdienstleister einen Paradigmenwechsel im therapeutischen Ansatz - zu einem Preis. Eine aktuelle Studie
Das IQVIA ™ Institut für Human Data Science zeigt, dass sich die Ausgaben für Krebsmedikamente in den USA verdoppelt haben
von 2012 bis 2017. Es wird erwartet, dass sich diese Ausgaben bis 2022 wieder auf mehr als 100 Mrd. USD verdoppeln werden. Im Laufe
Aufgrund dieser Entwicklung haben spezifische Biologika vor allem aufgrund von Preissteigerungen im Laufe des Jahres steigende Kosten verursacht. Wie
ein Beispiel, der Listenpreis der Referenzbiologie für unseren G-CSF-Biosimilar-Kandidaten hat sich mehr als verdoppelt (> 100%)
seit 2006; das ist mehr als das Vierfache des Anstiegs des Verbraucherpreisindex (VPI) für den gleichen Zeitraum. Wir glauben
das muss etwas geben. Biosimilars bieten eine mögliche Lösung für dieses eskalierende finanzielle Problem. Sogar die begrenzten USA
Die Erfahrung mit Biosimilars legt nahe, dass die Praxis der jährlichen Preiserhöhungen verkürzt und der durchschnittliche Verkaufspreis gesenkt wurde
Der Preis einer bestimmten biologischen Substanz wurde reduziert, als Biosimilars in den Markt eingeführt wurden.
Was unterscheidet Biosimilars von Generika?
Erstens haben sowohl Biosimilars als auch Generika das Potenzial, die gesellschaftlichen Gesundheitskosten zu senken. Das ist jedoch die Ähnlichkeit
endet. Ein Biosimilar ist ein biologisches Produkt, das dem biologischen Referenzprodukt sehr ähnlich ist. Biosimilars sind sehr komplex, biologisch
Therapeutika. Die Art eines biologischen Therapeutikums bedeutet, dass es wahrscheinlich geringfügige Unterschiede gibt, wenn auch nicht klinisch
bedeutsam, zwischen den hergestellten Produktionsläufen oder "Partien", einschließlich zwischen den Produktionspartien einer gegebenen Referenzbiologie. Dort
Es gibt keine klinisch relevanten Unterschiede zwischen dem Biosimilar und dem Referenzbiologikum in Bezug auf Sicherheit, Reinheit und Wirksamkeit

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Coherus Biosciences Inc. (NASDAQ: CHRS) hat eine Coverage, die mit einem Buy-Rating und einem Kursziel von 28,00 USD eingeleitet wurde

Durch

ICH Mitarbeiter

 -

28. August 2018

    

Analystenbewertungen für Coherus Biosciences Inc (NASDAQ: CHRS)
Heute hat HC Wainwright die Coverage von Coherus Biosciences Inc (NASDAQ: CHRS) mit einem Buy mit einem Kursziel von 28,00 USD initiiert.
Es gibt 5 Buy Ratings, keine Strong Buy Ratings, keine Verkaufsratings, keine Halten Ratings auf dem Stock.
Das aktuelle Konsens-Rating für Coherus Biosciences Inc. (NASDAQ: CHRS) lautet Kaufen mit einem Konsenszielkurs von 27,40 US-Dollar pro Aktie, ein potenzielles Plus von 45,36 Prozent.
Einige aktuelle Analysteneinschätzungen enthalten

8/28/2018-Coherus Biosciences Inc. (NASDAQ: CHRS) hat eine Coverage mit einem Buy-Rating und einem Kursziel von 28,00 USD initiiert

9/27/2017 - Coherus Biosciences Inc. (NASDAQ: CHRS) hat sein Outperform-Rating von der Credit Suisse Group mit einem Kursziel von 17,00 USD bestätigt

9/8/2017-Coherus Biosciences Inc (NASDAQ: CHRS) hat sein Outperform-Rating von Cowen mit einem Kursziel von 45,00 USD bestätigt

8/8/2017-Coherus Biosciences Inc. (NASDAQ: CHRS) hat seine Übergewichtung von JPMorgan Chase & Co. mit einem Kursziel von 25,00 USD bestätigt

Jüngste Insiderhandelsaktivitäten für Coherus Biosciences Inc. (NASDAQ: CHRS)
Coherus Biosciences Inc. (NASDAQ: CHRS) besitzt Insidereigentum von 19,57% und institutionelles Eigentum von 91,32%.

Am 13.8.2018 verkaufte Barbara K Finck, Insider, 1.760 Aktien zu einem durchschnittlichen Aktienkurs von 19,02 US-Dollar pro Aktie und die gesamte Transaktion belief sich auf 33.475,20 US-Dollar.

Am 23. Juli 2018 verkaufte CFO Jean-Frederic Viret 9.291 Aktien zu einem durchschnittlichen Aktienkurs von 18,56 US-Dollar pro Aktie und die Gesamttransaktion belief sich auf 172.440,96 US-Dollar.

Am 10.7.2018 hat Barbara K Finck, Insider, 1.760 Aktien mit einem durchschnittlichen Aktienkurs von $ 15,01 pro Aktie und einer Gesamttransaktion in Höhe von $ 26,417.60 verkauft.

Am 18.06.2018 verkaufte Barbara K. Finck, Insider, 1.760 Aktien zu einem durchschnittlichen Aktienkurs von $ 15,00 pro Aktie und die Gesamttransaktion betrug $ 26.400,00.

Am 16.05.2018 verkaufte Dennis M Lanfear, Insider, 20.984 Aktien zu einem durchschnittlichen Aktienkurs von 16,26 US-Dollar pro Aktie und die gesamte Transaktion belief sich auf 341.199,84 US-Dollar.

Am 8/8/2017 Alan C Herman, Insider, verkauft 17.535 mit einem durchschnittlichen Aktienkurs von 15,02 $ pro Aktie und die Gesamttransaktion in Höhe von 263.375,70 $.

Am 5.7.2017 verkaufte Alan C Herman, Insider, 600 Aktien zu einem durchschnittlichen Aktienkurs von $ 15,00 pro Aktie und die Gesamttransaktion betrug $ 9,000.00.

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UBS Group AG erwirbt 70.000 Aktien der Coherus Biosciences Inc (CHRS)

22. August 2018 - Von Linda Martinez

Die UBS Group AG hat ihre Position in Aktien von Coherus Biosciences Inc (NASDAQ: CHRS) im ersten Quartal um 642,1% ausgebaut, so das Unternehmen in seiner jüngsten Mitteilung an die Securities & Exchange Commission. Der Fonds hielt nach dem Kauf von weiteren 70.000 Aktien während des Quartals 80.902 Aktien des Biotechnologieunternehmens. UBS Group AG hielt 0,13% von Coherus Biosciences im Wert von $ 894.000 bei seiner jüngsten Einreichung bei der Securities & Exchange Commission.

Mehrere andere Großinvestoren haben kürzlich ebenfalls Aktien von CHRS gekauft und verkauft. Platinum Investment Management Ltd. steigerte seine Beteiligung an Coherus Biosciences im 1. Quartal um 25,5%. Platinum Investment Management Ltd. besitzt jetzt 137.000 Aktien der Aktien des Biotechnologieunternehmens im Wert von 1.513.000 USD, nachdem im letzten Quartal weitere 27.800 Aktien erworben wurden. Im 1. Quartal kaufte die Crucity Capital Management LP eine neue Beteiligung an Coherus Biosciences im Wert von 5.121.000 US-Dollar. Principal Financial Group Inc. erwarb im 1. Quartal eine neue Beteiligung an Coherus Biosciences im Wert von 115.000 US-Dollar. OMERS ADMINISTRATION Corp hat im 1. Quartal eine neue Beteiligung an Coherus Biosciences im Wert von 259.000 US-Dollar erworben. Schliesslich stockte JPMorgan Chase & Co. seine Beteiligung an Coherus Biosciences im 1. Quartal um 7,5% auf. JPMorgan Chase & Co. hält nun 2.045.068 Aktien der Aktien des Biotechnologieunternehmens im Wert von 22.598.000 US-Dollar, nachdem im letzten Quartal weitere 143.074 Aktien erworben wurden. Hedgefonds und andere institutionelle Investoren halten 82,70% der Aktien des Unternehmens

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Coherus BioSciences' (CHRS) CEO Dennis Lanfear on Q2 2018 Results - Earnings Call Transcript

Coherus BioSciences' (CHRS) CEO Dennis Lanfear on Q2 2018 Results - Earnings Call Transcript
Aug. 8, 2018 10:48 PM ET
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About: Coherus BioSciences (CHRS)
Q2: 08-02-18 Earnings Summary
• Press Release
• 10-Q
• News
EPS of $-0.68 misses by $-0.04
Revenue of $130M (+ Infinity% Y/Y)
Coherus BioSciences (NASDAQ:CHRS) Q2 2018 Results Earnings Conference Call August 8, 2018 4:30 PM ET
Executives
Jean Viret - CFO
Denny Lanfear - President, CEO and Chairman
Vince Anicetti - COO
Jim Hassard - SVP, Marketing and Market Access
Matt Hooper - EVP and General Counsel
Barbara Finck - CMO
Analysts
Mohit Bansal - Citigroup
Jason Kolbert - H.C. Wainwright
Douglas Tsao - Barclays
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences Second Quarter Earnings Conference Call. My name is Sonya, and I will be your conference operator for the call today. At this time, all participants are in a listen-only mode. And as a reminder, this conference call is being recorded.
I would now like to turn the call over to Jean Viret, Chief Financial Officer. Please go ahead.
Jean Viret
Thank you, Sonya and good afternoon, everyone. After close of market today, we issued a second quarter financial results press release. This release can be found on the Coherus BioSciences’ website.
Joining me for today’s call will be Denny Lanfear, President, CEO and Chairman; Vince Anicetti, Chief Operating Officer; Jim Hassard, Senior Vice President, Marketing and Market Access; Matt Hooper, Executive Vice President and General Counsel; and Dr. Barbara Finck, Chief Medical Officer.
Before we begin our formal remarks, I would like remind you that we will be making forward-looking statements with respect to product development and commercial plans, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ from these statements. A description of these risks can be found on our most recent Form 10-Q, which we filed this afternoon after market closed. In addition, we do not undertake any obligation to update any forward-looking statements made during this call.
I will now turn the call over to Denny.
Denny Lanfear
Thank you, Jean. We’ve had a very productive quarter here in Q2 of 2018, and we’re very happy to update you all on developments today. First, with respect to UDENYCA, formerly known as CHS1701 pegfilgrastim and biosimilar, today we will summarize developments for you in three key areas. First, we’re going to sharply focus on our commercial launch preparation and Mr. Hassard, our Senior Vice President of Marketing and Market Access will summarize these activities for you in just a moment.
Following my own remarks with respect to regulatory progress in Europe, the positive CHMP opinion, as well as progress with the FDA, our Chief Operating Officer, Mr. Vince Anicetti will summarize the results of certain FDA inspections of facilities related to UDENYCA development as well as our manufacturing progress in anticipation of the launch.
Lastly, we will have a review of the financial by the company’s CFO, Dr. Jean Viret, before we go to the Q&A. with respect to UDENYCA approval progress in Europe. At the end of July, we announced that the CHMP adopted a positive opinion with respect to the marketing authorization of UDENYCA. This decision provides the basis for the company’s first regulatory approval on a major developed market and validates both our UDENYCA biosimilarity package, as well as our biologics development platform and capabilities overall.
We now look forward to the formal European Commission approval decision around October 1, for the standard VMA regulatory process. With this UDENYCA has the opportunity to be one of the first pegfilgrastim biosimilars approved in Europe. I would like to thank the Coherus team for their extraordinary dedication and efforts to achieving this transformational milestone for our company.
Now with respect to the commercialization in Europe, we are currently engaged in discussions with various parties and we continue to progress in selecting the best options to maximize the long term commercial value of UDENYCA in this region. Now with respect to the progress on the US BLA, we have received certain information request from the FDA and we have responded to such request in a timely fashion in accordance with established processes and expectations.
At this point, we believe the application is tracking as expected and to the best of our understanding an advisory committee meeting will not be required prior to or to support approval. In terms of our manufacturing quality systems, as I indicated, our COO, Vince Anicetti will summarize certain FDA inspection and activities in just a moment. We continue to look forward to UDENYCA BLA action data of November 1, I should say November 3, 2018.
A few remarks are in order with respect to the biosimilar public policy, the FDA biosimilar action plan and pending the executive directives aimed at pricing and rebate policies. We’d like to commend Commissioner Gottlieb for his leadership with respect to the FDA biosimilar action plan, in particular his emphasis in seeking a creative environment that fosters competition in the US biologics market place. We look forward to the forthcoming executive directive from HHS aimed at pricing the rebate policies and to participate during a policy common period post issuance.
As the only US pureplay biosimilar company, we believe that we have a unique perspective and share the FDA and HHS goals of delivering healthcare system savings and improving patient access to biologics.
With that now Mr. Anicetti would like a few remarks with respect to manufacturing, quality and operations. Vince.
Vince Anicetti
Thanks very much Denny. So I’d like to provide a brief update on the operations side of our BLA effort, some recent inspections performed by the FDA at our facilities as well as our overall manufacturing launch readiness. First, we recently completed an FDA pre-approval inspection at our analytical lab in Camarillo, California. We are very happy to report that this inspection was completed successfully without the issuance of any 483s by the FDA.
As you know that this follows our previous FDA inspection at our Redwood Shores headquarters in which there are also no 483s issued. In addition, we also recently completed an FDA inspection of our contract laboratory that performs the immunogenicity assay which supported our clinical package at the BLA. This is a laboratory that validated and executed the revised immunogenicity assay with enhanced sensitivity as recommended by the FDA in a complete response letter. Once again we are very pleased to report that this inspection was completed without the issuance of any 483s by FDA.
I should note that we have prioritized the development of our quality systems here at Coherus and we’ve made substantial investments in staff and infrastructure, and it’s very rewarding to see this effort reflected in such positive inspection outcomes.
Now I’d like to add a few remarks on the manufacturing launch readiness side of our efforts. And as we previously discussed the Ugenic has both drug substance Eugenics have both drug substance or active ingredient is made here in the US at KBI Biopharma and older Colorado. KBI is our strategic partner and we’ve developed a close and successful collaboration together that continues.
I should also note that all other manufacturing operations for Eugenics are performed in the US and we are quite proud that this is a Made in the USA product. As you can imagine, our focus in 2018 is meant to be fully prepared for the launch in Eugenics both in the United States and in Europe to ensure certainty of supply and I can report that this is going well. We are continuing to successfully build inventory to supply a vigorous launch after regulatory approval and our ramp up plans to support long term demands while advancing consistent with our long term objectives.
I’ll be happy to take any further questions during the Q&A period.
Denny Lanfear
Thanks Vince, and congratulations to you and your team for a great job and excellent results in the quality and manufacturing side. Now I’d like to ask Jim Hassard, the company’s Senior Vice President of Marketing and Market Access to give you a review of our launch preparation activities and make a few more remarks in that direction. Jim.
Jim Hassard
Thank you, Denny. I’m happy to provide an update on recent and projected activities on the commercial front. In terms of our commercial ramp up, we are pleased to announce that field leadership in sales, key account management and market access teams are now fully in place. Our field leadership is comprised of regional sales directors or RSDs to whom the territory level sales team will report. We are pleased with the caliber of people that we had able to attract and their enthusiasm for bringing biosimilars to market.
In terms of scope, the team is size consistent with a traditional branded biologic launch and we are confident that we will be able to deliver sales and support to ensure our expected market penetration.
With respect to key account management, the teams are building strong relationships with the group purchasing organizations, as well as large account systems such as Integrated Delivery Networks or IDMs. This is important as the top seven group purchasing organizations represent over 80% of the market.
We are fortunate to have attracted individuals with deep relationships and experience in oncology to buy and build. Market access is responsible for relationships with the payers and making certain there are now impediments to UDENYCA reimbursement at the payer level, ensuring both providers and patients had access to UDENYCA.
As a reminder, the market structure is such that 50% of patients are covered by Medicare and the other 50% of patients are covered by commercial payers. On the public side, we have already made application for reimbursement coating with the center for Medicare services and on the private side we have made significant headwinds with top commercial payers.
In terms of the team, again, we have attracted highly experienced industry professionals tenured in Medicare, Medicaid and commercial payers. We are continuing our outreach and educational efforts to build awareness about Coheres BioSciences amongst the oncology community. We are pleased about the anticipation and excitement for biosimilar pegfilgrastim UDENYCA.
Finally let me make a few comments about the market characteristics, how we plan to compete and gain our expected share. First, as we have said before, this is a very large market. Neulasta is one of the largest oncology biologics in the United States, representing approximately $4 billion in sales. Second, this an episodic market where most patients are new to treatment. We don’t anticipate encountering switching barriers to adoption. Third, there is a large segment of the market if it is disadvantaged on pricing or we believe we have an opportunity to be attractive. And lastly, this will not be the first biosimilar launch in the United States and we have been students of lessons learnt from both biosimilar success in the short acting GCSF market as well less successful launches.
Our overall strategy is to provide a holistic value proposition to all stakeholders that goes beyond pricing and provides patient and provider services, high quality staff and reliable high quality supply. While we have pursuing the regulatory approval of UDENYCA, we have been conducting market research and advisory meetings with key stakeholders to understand their needs and expectations.
I am of course happy to take any questions you may have on the commercial side of the business during Q&A. Denny?
Denny Lanfear
Thanks Jim. As you can now tell from both Vince and Jim’s remarks, we are very excited about the opportunity, incoming approvals and the subsequent launch and we look forward to giving you more color on the next call in November.
With respect to the payer and market access side, I’d like to comment on one additional development which is the appointment of Dr. Samuel Nussbaum to the Coherus Board of Directors. Sam brings a world of experience in the payer side to the Coherus Board including decades in public policy and extensive tenure as Chief Medical Officer in Anthem. We are gratified to have his position, an industry veteran of Dr. Nussbaum caliber on our Board, and he has already provided highly valuable inputs on our plans and strategies.
With respect to our pipeline, we have no changing guidance at this time, and we look forward to updating you with respect to it on our next call.
Before we get to Q&A, the company’s Chief Financial Officer, Dr. Jean Viret will review the financials. Jean?
Jean Viret
Thank you Denny. I will walk you through the main aspects of this quarters’ financial performance. Research and development expense decreased this quarter over the same quarter last year by $8 million. The decrease in R&D expenses period-over-period was mainly due to a reduction in manufacturing, stakehold, analytical costs, associated with our anti-TNF programs CHS-0214 and CHS-1420 and a focus of resources to manufacturing UDENYCA.
The second quarter, just like all the recent quarters are expensing all costs related to the production of UDENYCA until we receive approval from the FDA. General and administrative expense also decreased by $5.1 million this quarter over the same quarter last year. This decrease was mainly attributable to decrease in personnel and in certain legal and consulting services as a result of cost control steps taken since June 2017.
Net loss attributable to Coherus for the second quarter of 2018 was $43.6 million or $0.68 per share, compared to a net loss of $55.3 million or $1.08 per share for the same period in 2017. Our cash, cash equivalents and marketable security totaled $159.8 million as of June 30, 2018 compared to $95.2 million as of March 31, 2018. Our use of cash in operations, during the second quarter of 2018 was $35.5 million in line with our guidance of $32 million to $37 million for that quarter.
We anticipate use of cash in operations between $48 million and $53 million in the third quarter of 2018, led by approximately $15 million from our second quarter use of cash as we prepare for UDENYCA’s approval in Europe and in the US and commercial launch.
We will now turn the call to Q&A. Operator you may open the call to questions.
Question-and-Answer Session
Operator
[Operator Instructions] Your first question comes from the line of Mohit Bansal from Citigroup. Your line is open.
Mohit Bansal
If I could drive deeper in to the commercial aspect of the business, so you did mention previously that 340B hospitals, you are in an advantageous position. I just wanted to look at 50% of the market which are the community clinics and some do get better pricing from Amgen. If you could help me understand what strategy you think would be the right strategy to go in to those clinics and go to the last mile there?
Denny Lanfear
Thanks to your question Mohit with respect to the clinics and 340B hospitals. We’ll let Jim Hassard take that one. Jim?
Jim Hassard
Thanks Denny. Mohit to your point, clinics do represent about 50% of oncology on Neulasta sales. I think the real point that we have been and the real strategy here is we’ve been building relationships with the group purchasing organizations and with their help an guidance we will again go at this segment of the market. Again the specifics in terms of targeting are still yet to be determined over the next few months.
Denny Lanfear
Mohit did you have a specific question with respect to the 340B and their economics that you want to clarify?
Mohit Bansal
If you could clarify, because a lot of people asked this question and how does that 340B hospital and defensive between ASP plus 6% minus or ASP minus 22.5, how does it work and also how could it impact the ASP itself or would it not?
Denny Lanfear
Jim can you run down the reimbursement on the 340B hospital for Mohit please?
Jim Hassard
Sure. So Mohit first of all to answer to answer your last question, discounts in to the 340B segment do not impact the average selling price calculations, so that’s an important first point. In terms of the reimbursement really again, biosimilars as any new market entrant in to the biologic space will be given the opportunity for two to three period of having a reimbursement calculation which is either black, the wholesaler acquisition cost or the average selling price plus 6%, and again that’s for the first two to three years
Current Neulasta has a reimbursement formula of ASP minus 22.5%. So really that’s the reimbursement side, really in order to be attractive in that setting Mohit, what it really depends on is what our pricing will be within the 340B segment and that is yet to be determined. We will give you guidance on that closer to November.
Denny Lanfear
But to Jim’s point you’re clear that the 340B hospital pricing does not impact overall ASP reimbursement?
Mohit Bansal
This is very helpful and then if I can ask a little bit more about your manufacturing efforts and how soon can we cease a filing there and then obviously how do you plan to navigate the IP landscape there. Thank you.
Jim Hassard
Do I understand your question with respect to manufacturing to be when we would see a filing?
Mohit Bansal
Yeah, you said that you are working on the manufacturing efforts to get to the filing point there because you’ve already run the studies there. So just trying to understand the next steps there and when can we get to the filing point.
Denny Lanfear
With respect to the manufacturing we have previously disclosed that there have been inspections both by FDA and EMA. So there are no further activities with respect to filing manufacturing. The manufacturing information and the facility information is contained in the BLA and in the corresponding documents for EMA, no further activity is anticipated there. Thank you for your question. Let’s move on.
Operator
Your next question comes from the line of [Bill Mohan] from Cowen. Your line is open.
Unidentified Analyst
So my question is based on the recent approval of the first biosimilar Neulasta. It seems that we still haven’t seen that on the market yet, do you guys have any visibility as to when that launch might happen and as their first to market advantage seems to be dwindling at this point.
Denny Lanfear
So just to be clear what we have had so far is a recommendation for approval not an actual approval. Jim why don’t take a follow-on to the question about the market and so on for the rest of the time issues.
Jim Hassard
So your question with regards to the first biosimilar pegfilgrastim approved here in the United States correct.
Unidentified Analyst
Yes.
Jim Hassard
So our understanding was that approval took place in early June and there actually is, they did announce product available within the channel July 9. So it’s really been a very short period of time between now today and that actual product in channel launch July 9.
Unidentified Analyst
And you have any comment on sort of the strength in that marketing effort to this point?
Jim Hassard
Still we’re trying to be students and trying to understand what is going on in the market place from that launch, but it’s still early days. It’s too early to really assess what their performance is etcetera.
Operator
Your next question comes from the line of Mike (inaudible) from Bears. Your line is open.
Unidentified Analyst
Just with respect to the BLA Denny you mentioned the FDA request of some additional information that you’ve already provided. I’m just curious if you can maybe provide a little bit of additional color on the type of information that was requested. And then secondly, was that information similar to some of the request you got from the EMEA during that process. So I am just trying to get a sense of whether the FDA is sort of diverging in the process from sort of what types of questions you are getting from the EMEA?
Denny Lanfear
No the FDA is not diverging. These are routine questions typically regulators will ask you to just look at data a slightly different way. They’ sort of – can you slice it this way so we can look at it, that’s sort of a typical thing. It’s not – these are all routine questions, I wouldn’t characterize them any other way. I would point out that the EMA has seen the same immunogenicity there that the FDA is looking at now and it found it worthy for recommendation for approval, so no divergence that we see whatsoever
Operator
[Operator Instructions] Your next question comes from the line of Chris (inaudible) from JP Morgan. Your line is open.
Unidentified Analyst
Just two here, first with regards to UDENYCA and in part B. I guess with some of the recently announced changes that allow more negotiations within Medicare Advantage for Part B drugs or some of the broader proposals to move more of Part B in to Part D. Are you seeing anything in there that would impact your thinking or strategy around how you would approach the market etcetera that we should be keeping in mind.
And then my second question, as you enter in to the top seven GPOs representing about 80% of the market, how do you expect the GPOs to handle biosimilars? Will this be a situation where you’re going to see GPOs work with multiple players in the market or do you expect each of the organizations to look to partner with just one player?
Denny Lanfear
Thanks Chris. Jim would be happy to give you a little clarity in our thinking around the Part B Jim?
Jim Hassard
Yes, so on the two questions Chris, so first of all Part B this is a roughly a new piece of or a new announcement from CMS, I believe that came out yesterday. So what CMS or what the trump administration I believe plan to do is empower the Medicare Advantage plans to essentially begin negotiations and maybe provide or put in place prior authorizations etcetera. And that would be effective January 1. So first of all, just to baseline us on what does that represent? So Medicare Advantage is not all Medicare. Medicare Advantage is essentially organized and run by the commercial payers on behalf of Medicare and we estimate that that represents about 5% or 10% of total Neulasta sales.
In terms of how’s the strategy there, Medicare Advantage plans are actually incentivized to operate efficiently to try to reduce costs etcetera and we really feel that biosimilars will play an important role as a solution for Medicare Advantage plans in the years forward. Does that answer your question Chris?
Unidentified Analyst
Yes. So I guess my question is, does that switch relevance to you guys or either way it was already incentives in place for these plans to already be focused on biosimilars?
Jim Hassard
I think again they are incentivized to reduce cost, and some of these plans have been focused on the use of generics etcetera. So I think biosimilars just play a natural role with Medicare Advantage plans.
Denny Lanfear
Chris, this is Denny. I would just remark that the over-arching theme of the administration we view as very favorable to biosimilars, whether you look at Commissioner Gottlieb’s remarks, whether you look at (inaudible) remarks at HHS or CMS or other things. So there’s a very consistent scene and set of actions coming through the administration which we believe are very positive for biosimilars this included.
Jim Hassard
And Chris on your second question with regards to GPOs, I don’t want to speak on behalf of the Group Purchasing Organizations, they act on behalf of their membership. It’s their role to choose the best strategy and the best brands for their membership. But I will say this, the feedback that we’ve received is not over-priced. Its price is just one of the components they really are looking for a value proposition that includes patient provider services certainty of supply, things that go way beyond price. So we’ll just have to wait to see what they’re choices are, but again don’t want to speak on their behalf.
Denny Lanfear
And I’ve also interacted with several of these things Chris. The other complimentary remark I would make in addition to Jim’s is there is a palpable enthusiasm among all of these groups for biosimilars. They relish the opportunity, they have a choice to be able to have competition in the market place and so on. So I think it’s very healthy for the market place and I think it’s good for the healthcare system.
Operator
Your next question comes from the line of Jason Kolbert from H.C. Wainwright. Your line is open.
Jason Kolbert
I just wanted to clarify one point, it kind of relates to pricing in the market place. I know it does get a little bit confusion, and the size of the market place. The CEO Myland talked about double-digit discounts, but when I do the math and in our conversation it becomes clear that in reality it’s just a very moderate discount they are offering, a couple of percent off of the ASP. So can you spend a few minutes just talking about the real price of Neulasta as it’s sold versus kind of the published numbers, so that we can understand some of the factors that explains why the Mylan launch is so anemic.
Denny Lanfear
That’s of course a very confusing topic is pricing the discounts and so on. I’ll let Jim take a shot at, giving a little color to that Jim.
Jim Hassard
So just to address your question, the two prices that are publicly available as published by Compendia and also published by CMS. So the list price of Neulasta is about $6200 per pre-filled syringe. The average selling price for Neulasta as published by CMS is about $4200. So to your point there’s about 33% gap between the list price and the average selling price, the net price for Neulasta. Now Mylan’s price, their list price that they came to market with in July of this year is to your point only about 6%. It’s about 41.75. So it’s just 6% below the average selling price that most of the market sees with Neulasta.
Jason Kolbert
And just to change gears a little bit, in advance of your launch and in anticipation of approval, can you talk a little bit about the structure of the sales force, who has been hired and who still is on your short list to be hired?
Jim Hassard
Again going back to my remarks, from the call today, who have hired is we have hired the regional sales directors from the sales side. We have completely filled out the key account management team now and we have completely filled the market access team. So right now still to be hired are we anticipated having approximately 70 sales representatives or territory account managers and again we’re building a short list at current and we’ll pull the trigger on hiring those territory account manager closer to approval.
Jason Kolbert
And just one last question, this has to do with the comment that Sean made about expensing some of the product that’s already been produced. Can you give us some idea of the magnitude of the magnitude of that number, because that sounds like upon launch you will be using already expensed products. So your initial cost of good will essentially be zero at least at the time of launch.
Jim Hassard
JV would you like to hold that one for Jason.
Jean Viret
In this cost of goods will be pretty very small and they’ll have to do final package. So that’s pretty much what you’re going to see hitting the cars line plus the couple of the small shipping passes are. In terms of the amount of inventory that I have on hand will provide more guidance as we get close to launch. But you could look particularly at changes in R&D expenses and focusing on 10-Q and you can get an idea of how much in dollar amount we’ve been providing reducing your daily count.
Operator
Your next question comes from the line of Douglas Tsao from Barclays. Your line is open.
Douglas Tsao
Maybe starting point, sort of perspectives you referenced to part with the opportunity to partner, the 1701 or in Europe. What other regions do you think potentially represents sort of meaningful commercial opportunities for you outside of the sort of the major markets.
Jim Hassard
Well as you know we have retained by and large global rights to all of our parts including UDENYCA. So there is of course Asian rights, Japanese rights, all those areas in addition to Europe and so on. Our current efforts are focused on the European market, that’s a second largest market after the US of course. I think it’s approximately ab0ve the $700 million market. We believe that probably the most important market after the US to pay the exclusivity timing and Japan is few y ears off, I think its five or six years off. And so we think that Europe probably constitutes the second most attractive market for UDENYCA globally
And on the other point that I would make for you, is if we do seek a deal or we were seeking more profit sharing backside loaded as opposed to upfront at this point in the company’s evolution. Having garnered the recommendation for approval.
Douglas Tsao
And then Denny with 14 final years we sort of approached market formation in Europe. Any updates in terms of kind of monetize that opportunity?
Jim Hassard
We are occupying ourselves at the current with certain pipeline developments including 1420 in the opthalmolgogy franchise and so on. So we prefer just to update the street at the next call on that. But that’s something of course that we have in cross hairs and have been focused on.
Operator
With no digital questions, I will now turn the call back over to Mr. Lanfear for closing comments.
Denny Lanfear
Thank you all for joining us there in the Q2 Coherus 2018 call. As we indicated that we’ve made some very good progress so far this quarter. We are very excited about the launch and the potential approvals. I think the teams’ done just an extraordinary job moving the objective forward or this quarter. We’ll look forward to more progress. There is a few conferences that we will be having in first week of September. We will be out on the East Coast in New York and Boston. So for something to look forward to seeing you there.
Operator
Ladies and gentlemen, this concludes today’s conference. Thank you for your participation and have a wonderful day. You may all disconnect.

[007coolinvestor]

Coherus BioSciences' (CHRS) CEO Dennis Lanfear on Q2 2018 Results - Earnings Call Transcript

https://seekingalpha.com/article/4196833-coherus-biosciences…

[E301173K]

Coherus BioSciences veröffentlicht Finanzergebnisse für das zweite Quartal 2018 am 8. August

24. Juli 2018 08:00 ET | Quelle: Coherus BioSciences, Inc.

REDWOOD CITY, Kalifornien (ots / PRNewswire) - Coherus BioSciences, Inc. (Nasdaq: CHRS ) gab heute bekannt, dass die Finanzergebnisse für das zweite Quartal 2018 nach Börsenschluss am Mittwoch, den 8. August 2018 veröffentlicht werden. Ab 16:30 Uhr ET wird das Coherus-Management eine Telefonkonferenz zur Erörterung der finanziellen Ergebnisse und zur allgemeinen Aktualisierung des Geschäfts anbieten.  
Nach Veröffentlichung der Finanzergebnisse für das zweite Quartal 2018 werden wir sie auf der Coherus-Website unter http://investors.coherus.com veröffentlichen .
Informationen zur Telefonkonferenz
Wann: Montag, 8. August 2018 um 4:30 Uhr ET 
Dial-in: [phone] (gebührenfrei) oder [phone] (International) 
Konferenz - ID: 4562488 
Webcast:  http: / /investors.coherus.com
Bitte melden Sie sich mindestens 10 Minuten vor der Konferenz an. Der Webcast wird auf der Coherus-Website archiviert.
Über Coherus BioSciences, Inc.
Coherus ist ein führendes pure-play, globales Biosimilar-Unternehmen, das hochwertige Therapeutika für große regulierte Märkte entwickelt und vermarktet. Biosimilars sind für die Verwendung anstelle von bestehenden Marken-Biologika gedacht, um eine Reihe von chronischen und oft lebensbedrohlichen Krankheiten zu behandeln, mit dem Potenzial, Kosten zu senken und den Zugang für Patienten zu erweitern. Bestehend aus einem Team von ausgewiesenen Veteranen der Branche mit erstklassigen Kenntnissen in den Bereichen Prozesswissenschaft, analytische Charakterisierung, Proteinproduktion, Vertrieb und Marketing sowie klinische und regulatorische Entwicklung, positioniert sich Coherus als einer der Marktführer auf dem globalen Markt für Biosimilars. Coherus entwickelt drei klinische Produkte im fortgeschrittenen Stadium der Vermarktung, CHS-1701 (Pegfilgrastim-Biosimilar), CHS-1420 (Adalimumab-Biosimilar) und CHS-0214 (Etanercept-Biosimilar), sowie Entwicklung einer robusten Pipeline von zukünftigen Produkten in vier therapeutischen Bereichen, Onkologie, Immunologie (Anti-TNF), Augenheilkunde einschließlich CHS-3351 (Ranibizumab Biosimilar) und CHS-2020 (Aflibercept Biosimilar) und CHS-131, ein kleines Molekül für Multiple Sklerose. Für weitere Informationen, besuchen Sie bittewww.coherus.com .
KONTAKT: 
Jean-Frédéric Viret 
Finanzvorstand 
Coherus BioSciences, Inc. 
[e-mail]
[phone]

[Sugar2000]

Coherus Bio's European application for Neulasta biosimilar under review; shares up 16% after hours

Jul. 17, 2018 4:31 PM ET|About: Coherus BioSciences (CHRS)|By: Douglas W. House, SA News Editor

•Coherus BioSciences (NASDAQ:CHRS) reports that it has satisfied the Day 180 issues related to its European marketing application seeking approval for Neulasta biosimilar CHS-1701. The application is now officially under review by the EMA.

•Shares are up 16% after hours.

[E301173K]

Coherus BioSciences reicht Zulassungsgesuch für CHS-1701 (Pegfilgrastim Biosimilar Candidate) erneut ein

Von GlobeNewswire,  3. Mai 2018, 09:16:00 EDT

Stimme hoch

AAA



Redwood City, Kalifornien (ots / PRNewswire) - Coherus BioSciences, Inc. (NASDAQ: CHRS ) gab heute die erneute Einreichung seines Antrags auf Zulassung für Biologika (BLA) für CHS-1701, eines Pegfilgrastims (Neulasta ®) Biosimilar-Kandidat an die US-FDA unter dem 351 (k) -Pfad.

Das BLA wird durch Ähnlichkeitsdaten von analytischen, pharmakokinetischen, pharmakodynamischen und immunogenischen Studien gestützt, die CHS-1701 und Neulasta vergleichen und neue Daten zur Immunogenität integrieren, die durch Verwendung eines überarbeiteteren Immunogenitätsassays erhalten wurden.

"Die erneute Einreichung des CHS-1701 BLA ist ein wichtiger Meilenstein in unserem laufenden Übergang zu einem kommerziellen Unternehmen, da wir uns auf die Umsetzung unseres strategischen Plans konzentrieren", sagte Denny Lanfear, President und CEO von Coherus BioSciences.  "Pegfilgrastim ist das am größten verkaufte Onkologieprodukt in den USA und CHS-1701 ist der Eckpfeiler unserer Onkologie-Sparte. Wir glauben, dass wir mit diesem Produkt eine starke Wettbewerbsposition haben, zum Beispiel unsere umfassenden klinischen Immunogenitätsdaten sowie unsere exzellente analytische Biosimilarität Daten."

Über Coherus BioSciences, Inc.

[007coolinvestor]

Coherus BioSciences' (CHRS) CEO Dennis Lanfear on Q3 2017 Results - Earnings Call Transcript
Nov. 6, 2017 7:47 PM ET
|
About: Coherus BioSciences (CHRS)
Coherus BioSciences, Inc. (NASDAQ:CHRS)
Q3 2017 Earnings Conference Call
November 06, 2017, 16:30 ET
Executives
Patrick O’Brien - SVP of IR
Dennis Lanfear - Chairman, CEO and President
Jean-Frédéric Viret - CFO
Michael Fleming - EVP, Sales and Marketing
Lisa Bell - EVP of Global Regulatory Affairs
Analysts
Mohit Bansal - Citigroup
Steven Seedhouse - BMO Capital Markets
Christopher Schott - JPMorgan Chase & Co.
Tyler Van Buren - Cowen and Company
Douglas Tsao - Barclays PLC
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Coherus BioSciences Third Quarter Earnings Conference Call. My name is James, and I will be your conference operator for the call today. [Operator Instructions]. And as a reminder, this conference call is being recorded.
I would now like to turn the call over to Patrick O’Brien, Senior Vice President of Investor Relations. Please go ahead.
Patrick O’Brien
Thank you, James, and good afternoon, everyone. After close of market today, we issued a third quarter financial results press release. This release can be found on the Coherus BioSciences' website. Joining me for today's call will be Dennis Lanfear, President and CEO and Chairman; Jean Viret, CFO. Before we begin our formal remarks, I'd like to remind you that we will be making forward-looking statements with respect to product development plans, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ from these statements. A description of these risks can be found in our most recent Form 10-Q on file with the SEC. In addition, Coherus BioSciences does not undertake any obligation to update any forward-looking statement made during this call.
I would now like to turn the call over to Denny.
Dennis Lanfear
Thank you, Patrick, and thank you all for joining us this afternoon. Today, we're going to talk about three key areas. First of all, I'm going to share with you an update on our lead asset, CHS-1701, including the status of the BLA resubmission. Secondly, we'll discuss certain advancements in our pipeline. And then lastly, our Chief Financial Officer, Jean Viret, will present a few highlights of this quarter's good financial results.
So let me first start to discuss 1701 and the progress on the resubmission. As you may recall, there's 2 parts of the CRL, the immunogenicity and the CMC-related questions. I'll first address the immunogenicity issues.
As you may recall, we stated on our last call that we have successfully completed developments of the immunogenicity assay and that validation with a subsequent step followed by a meeting with the agency and processing the samples. We have now successfully completed the validation of the immunogenicity assay, and we believe these results are consistent with the expectations for higher sensitivity, consistent with the FDA's request.
Now pursuant to the additional manufacturing and process-related issues, which comprised the second part of the CRL, I have an update there for you. We have now completed these analyses and reports. And as discussed, we are confident in our approach to these issues and plan to validate such with the agency in upcoming discussions.
In terms of next step with the agencies, upon meeting and reaching concurrence with the FDA and completed the sample analysis, we plan to do the resubmission directly thereafter. We are tracking closely to our prior guidance for the end-of-the-year submission plus some scheduling allowance with a submission date of mid-Q1 2018. We will announce the acceptance of the BLA by the FDA, which should be 30 days after submission. And as previously stated, we expect the FDA review timing to be 6 months.
Now with respect to the 1701 MAA and European update, as you know, the EU and the U.S. filings are progressing in parallel as we previously noted. Consistent with our earlier remarks, the MAA would like to align data sets with the FDA, including those with respect to immunogenicity. Thus, we expect the MAA opinion in roughly the same time frame as targeted for FDA approval.
Now let me cover a couple of other matters regarding the 1701 product. First, the FDA has formally denied Apotex's citizen's petition without comment. We interpret this as a lack of requirement for clinical data in patients who demonstrate biosimilar of pegfilgrastim, which in turn supports our development plan. And as we have stated previously, the FDA did not suggest in the CRL that we would need to complete a Phase III study in patients.
Secondly, we were very pleased at November 1, 2017, CMS adopted a final policy to establish separate J-codes for each biosimilar biological products for particular reference product beginning January 1, 2018. This means that a physician reimbursement of our product under CMS will not be linked to the price of a biosimilar competitor product in the same class. The ASP of our product, upon which reimbursement is based, will thus be more fully under our control.
This is a very important step for us in the biosimilar industry and has the potential to accelerate development and adoption of our products. Michael Fleming, our Executive Vice President of Sales and Marketing, is with us who'll be happy to provide more color during the Q&A session.
Now let me make a few remarks pursuant to our pipeline priorities. We are prioritizing our efforts in ophthalmology and our franchise there and are currently focused in our Lucentis biosimilar, CHS-3351. We believe ophthalmology is an attractive market well-suited to our portfolio, both from the viewpoint of unmet patient needs, cost of goods as well as competitive dynamics and other key selection criteria. We'll be updating you on the clinical and regulatory timing on this product on subsequent calls.
Now with respect to CHS-1420, our adalimumab biosimilar program, we were disappointed during the quarter that the patent office decided not to institute our '619 IPRs, given the abundant [indiscernible] signed the petition, which specifically disclosed the feasibility in motivation for making buffered protein formulations. Our view is that the PTAB's rationale applied in [indiscernible] low standard of patentability that is not consistent with decades of established legal process.
Numerous cases in the Fed Circuit have held that [indiscernible] can render the event as obvious without the certainty of success, even if some experimentation is needed. However, in line with these '619 IPR outcomes, we're now going to focus on securing a competitive HUMIRA biosimilar launch when certain formulation patents expire in mid-2022. And our near-term spend on 1420 has been redirected to our ophthalmology franchise.
Now let me talk a little bit about CHS-0214. With respect to our etanercept biosimilar product, we are expanding our efforts on the U.S. market. To support this opportunity and as previously discussed, we filed IPRs on 2 engine-controlled patents directed to the etanercept protein. The so-called '522 and '182 Brockhaus patents, which expire in 2028 and 2029. Institution decisions are expected on these in March of '18.
As I said, I'd be happy to take additional questions during the Q&A. And with that, I will hand it over to Jean Viret, our CFO, for the financial results summary. Jean?
Jean-Frédéric Viret
Thank you, Denny. Let me give you an update on our financial position and results. Cash, cash equivalents and investments and marketable securities totaled $150.1 million as of September 30, 2017, as compared to $118.3 million as of June 30, 2017. Cash used in operations was $41.5 million in the third quarter, consistent with our guidance, down 25% from the $55.6 million used in the second quarter of 2017, and down 43% from the $73.3 million used in the first quarter of 2017.
In August 2017, we announced that Temasek, the investment company headquartered in Singapore, plans to invest up to $150 million over 2 tranches. We received a first tranche of $75 million in aggregate proceeds on August 24, 2017. The second tranche is projected to be funded following receipt of the FDA's marketing approval for CHS-1701 pegfilgrastim biosimilar product candidate, subject to market pricing and that certain closing conditions at that time, including each party's final approval.
We anticipate cash used in operations of approximately $35 million to $40 million in the fourth quarter of 2017, down approximately $5 million from previous guidance, and $30 million to $35 million per quarter in the first quarter of 2018.
Research and development expenses for the third quarter of 2017 were $42.6 million as compared to $64.6 million over the same period in 2016. R&D expenses for the 9 months ended September 30, 2017, were $130.9 million as compared to $195.4 million in the same period in 2016. Decreases in R&D expenses were mainly attributable to a decline and end of clinical activities for CHS-0214, CHS-1420 and CHS-131 during the preceding 12 months.
We continue to produce bio drug substance and drug product for CHS-1701 in order to prepare for commercialization. And the cost associated with these products are expense in R&D until such time we receive regulatory approval on this cost or capitalized as inventory.
General and administrative expenses for the third quarter of 2017 were $14 million as compared to $13.6 million for the same period in 2016. G&A expenses for the 9 months ended September 30, 2017, were $56.3 million as compared to $36.3 million for the same period in 2016. Changes in G&A expenses were mainly attributable to legal and other professional fees to support intellectual property litigation and IPRs as well as personnel-related costs to support CHS-1701 pre-commercial activities in the first 6 months of 2017. We continued to prepare for CHS-1701 launch, and as a result, we have maintained certain pre-commercial activities that are essential to prepare for successful launch.
Net loss attributable to Coherus for the third quarter of 2017 was $59 million or $1.09 per share as compared to a net income attributable to Coherus of $83.9 million or $1.67 per share for the same period in 2016.
We will now turn the call to Q&A. Operator, you may open the call to questions.
Question-and-Answer Session
Operator
[Operator Instructions]. Your first question comes from Mohit Bansal.
Mohit Bansal
So Denny, one quick question for you is like, have you already requested a meeting with the FDA and do you plan to communicate when such a meeting will take? Therefore, do you plan to communicate to the street as and when this meeting happens?
Dennis Lanfear
Mohit, thank you very much. We are currently discussing meetings with the FDA. We do not plan to offer updates as we have those meetings. I think what you can look forward to is announcements pursuant to the filing or acceptance of the BLA. But with -- we are currently in process with them, and we'll offer updates if required, but that is not our plan right now.
Mohit Bansal
Got it. And then if I can ask 1 follow-up. So maybe I couldn't understand it, but you mentioned that sample runs are being done right now. So is it done already? Or you have completed the assay validation at this point and the sample runs would -- are happening right now and that will continue until the end of the year?
Dennis Lanfear
So as we have previously stated, the development -- the assay issue was in three parts. First, the development; secondarily, the validation; and then thirdly, the actual running the samples, meetings with the FDA, et cetera. So we have successfully completed the first part, which was development of the assay. We talked about that in the last call. We said that we would go ahead and get the assay validated in this time frame. We're reporting to you today that we have successfully now validated the assay, and then we're moving forward. So we look forward to going forward with the program. But you no, we have not yet initiated that.
Operator
Our next question comes from Ian Somaiya with BMO Capital Markets.
Steven Seedhouse
It's Steve on for Ian actually. Have you guys have discussions with the FDA about Amgen's manufacturing in Puerto Rico and whether or not that's increasing the sense of urgency to approving your last biosimilar?
Dennis Lanfear
We would not comment on any discussions pursuant to our policy of discussing things with the FDA regardless of topic, including this topic that you cite.
Steven Seedhouse
Okay, no problem. What about -- so -- maybe a more general question then regarding interaction with the FDA. When you submit the BLA, when we hear from you guys about acceptance or validation, is it -- does FDA look at the day that you submit before validating? In other words, will they check the assay specifications and the data and confirm that it's roughly aligned with their expectations? Or what's your expectations be between hearing about validation and ultimately the decision on the BLA?
Dennis Lanfear
I'll let the company's Executive Vice President of Global Regulatory, Dr. Lisa Bell, answer that. Lisa?
Lisa Bell
Hi there. So the process leading up to resubmission in response to a complete response letter, that one and FDA's SOPs, and essentially what it boils down to is that the sponsors required to meet with the FDA to make sure that you have agreement on the content of the resubmission, so that way, they -- both parties are clear on what the expectations are and that what is going to be provided is going to be sufficient. So yes, we will have -- be having conversations with them to make sure that we are ensuring that prior to the resubmission going into them.
Steven Seedhouse
Okay. And one more question, real quick, if I could. Have you -- have the assay been validated at multiple sites or at a single site? And are you moving ahead with the sample testing at 1 or more sites? And if 1 site, is it due to any differences and the assay is being utilized at different sites? Or are there no differences maybe you can point to?
Dennis Lanfear
What we have disclosed today is that we have completed validation of the assay and we have made no further comment with any other aspect of this assay. We believe that the assay has validated as suitable for processing the samples.
Operator
[Operator Instructions]. Our next question comes from Chris Schott with JPMorgan.
Christopher Schott
Just two questions here. Speaking on 1701 on the commercial side, maybe just elaborate a little bit more on the separate J-code in terms of what that could mean to your commercial approach and just commercial dynamics around the product once it's launched. And then my thoughts there -- I'm sorry, I'll ask separate.
Dennis Lanfear
Yes, no, go ahead, Chris. You can ahead with your second question.
Christopher Schott
I was just saying the second one was just a similar competitive landscape question. Just you mentioned Apotex, but as we -- as you look in the competitive landscape from what's been publicly disclosed, how are you thinking about the market here between Sandoz and some of the recent Mylan updates?
Dennis Lanfear
Yes. Thanks for the comments or the questions here, Chris. I'll ask Michael Fleming, our Executive Vice President of Sales and Marketing, take the questions on J-code and simplifications, and then I'll follow-up with competitive snapshot. Michael?
Michael Fleming
Chris, thanks for the question. So yes, this is a very significant outcome for the biosimilar industry. Because we have and will be assigned our own J-code, it means essentially that we'll be fully in control of our product price. We will not be dependent or linked to a competitor's price. This means that we would expect less pricing volatility, and it will allow us and our customers to have a more orderly plan for pricing and adoption dynamics in the marketplace. So essentially, this means that we're masters of our domain. And it means that our industry is going to be able to accelerate investment in our products going forward. We also know and we've seen market research to demonstrate that physicians will have higher adoption rate of biosimilars if they had their own similar J-codes. This means we would expect better adoption in the marketplace. We've seen that through our market research, and I believe Sandoz has run similar research and found the same thing. So all in all, this is a very, very significant outcome for us.
Dennis Lanfear
Very, very positive one. Chris, pursuant to your question with respect to competition, to the best that we can tell, the -- there's 2 or 3 other teams that are involved here. First of all, of course, there's Sandoz that withdrew their file, and I believe that Sandoz has announced that they're going to refile sometime in early 2019. And then there's Mylan. And of course, Mylan received a complete response letter last month and made additional comments, I think, on their call. And I would direct you to Mylan themselves for additional comment on there. Now in terms of Apotex, they're a private company. And to the best of our knowledge, they haven't made any public pronouncements one way or another about what's going on with their application, which was filed, I think, in the second half of 2014 or other issues. So for us, those are the 3 that are on our radar right now. So we're very hopeful in a positive outcome of our resubmission and getting on the market.
Operator
Our next question comes from Tyler Van Buren with Cowen and Company.
Tyler Van Buren
Just wanted to spend a little bit time perhaps on the Lucentis -- biosimilar Lucentis opportunities since there's going to be an increase focus on that. Perhaps you could just give us maybe a broad picture in terms of the time line to development when you think it could potentially reach the market as well as the -- clearly, the opportunity is large, but maybe just what you're seeing on the competitive landscape in terms of how many potential players there are.
Dennis Lanfear
Tyler, thanks for the question. As I said in my prepared remarks, we will, in the future, provide additional guidance regarding the timing of the clinical program, certain regulatory developments and so on. I think it's fair to say that we've been focused on that and gave a little bit of attention. I think that we have a -- developing a very good understanding of the clinical implications and so on for this product. We like this product a lot for a number of reasons. We like the -- first of all, it's an unmet need for the patients. So it's a great product. It also has a very well-controlled COGS price ratio, which is advantageous. It has high scientific hurdles and a few challenges, which we think are actually advantageous. A lot along, for example, the CHS-1701 have progressed in experience.
We see in the U.S., there's probably 1, maybe 2 other competitors, so we see a limited set there. We think that there's a very strong market for it, with the products in this category selling up to, I don't know, $8 billion or $10 billion a year. And then we believe that it's a very good product for us for a number of reasons and a number of sales call points and whatever. So I appreciate your patience. We'd be filing some additional updates on the timing of this product going forward.
Operator
We have time for one more question. Our next question comes from Douglas Tsao of Barclays.
Douglas Tsao
Just maybe a little bit of an update at exactly where things stand in terms of development of 1420. Certainly, perhaps more so from the commercial standpoint in terms of potentially looking to partner it and how you sort of look at it now investing in that product given where we are with the IPRs.
Dennis Lanfear
Thanks for the question, Doug. And so as I said in the call, in my prepared remarks, we believe that the most prudent path forward for us is to prepare for our launch in mid-2022 when certain patents come off and expire. We have redirected some of the intended spend for 1420 towards the ophthalmology program. We think that our product would be highly competitive at the time that it comes on the market. We have a very nice product. It's been successful in a number of clinical trials. However, we think that the refocusing of the emphasis on the ophthalmology portfolio is warranted. And we believe that, that's the best use of our focus. So it's actually, I think the anti-TNFs are third focus in our portfolio at the present time.
Douglas Tsao
Okay. And then in terms of development of the Lucentis or thinking about bringing that forward or commercializing that, would that be something that, given the nature of the physician base and the specialist, that you could perhaps pursue on your own similar to 1701? Or would that be one where you feel like a partner might be necessary from a commercial standpoint?
Dennis Lanfear
Yes, I'll let Michael Fleming take that one. Michael, you want to make some comments about the [indiscernible]
Michael Fleming
Yes, I'll do it very briefly, Doug. So yes, this is something that we would commercialize ourselves. It's a very attractable commercial opportunity. Very, very highly concentrated, delivered through ophthalmology and retinal specialist. They have to be able to do this. It's Medicare-based. Roughly 80% of this business is Medicare. And so it's commercially very attractable for us, and we would do that.
Operator
Thank you. With no additional questions, I'll turn the call back over to Mr. Lanfear for closing comments.
Dennis Lanfear
Thank you very much. And thank you for, all, being with us today. I think that we've had a very good quarter. We've had excellent progress on the complete response letter issues. The validation is now completed. We've also had very good success with the CMC issues. We look forward to getting guided with the FDA, as Dr. Bell pointed out, prior to the resubmission. And then secondarily, on the financial side, I think that Dr. Viret and his team have done a very nice job. We've controlled the burn. We've come right in the guidance, and we've guided down for the next quarter and we've also been very successful in fundraising with a large international team. And thirdly, I think we refocused our portfolio appropriately and brought forward with more emphasis the ophthalmology program. So look forward to seeing you all next call, and thank you very much.
Operator
Thank you. Ladies and gentlemen, that does conclude today's conference. Thank you very much for your participation. You may all disconnect. Have a wonderful day.

[007coolinvestor]

Coherus BioSciences Reports Third Quarter 2017 Operating and Financial Results

REDWOOD CITY, Calif., Nov. 06, 2017 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq:CHRS), today reported financial results and reviewed corporate events for the third quarter ended September 30, 2017.

Corporate Highlights for the Third Quarter 2017 Include:
Immunology (anti-TNF) therapeutic franchise:

CHS-0214 (etanercept (Enbrel®) biosimilar candidate)
- Filed petitions for Inter Partes Review (“IPR”) in the United States Patent and Trademark Office seeking invalidation of U.S. Patents 8,163,522 (“ ‘522 patent”) and 8,063,182,
- (“ ’182 patent”). Both are generally directed to the etanercept protein, the pharmaceutically active component of Enbrel
- We expect the PTAB to enter decisions on whether to institute these two IPRs by March 13, 2018 (for the ’522 patent) and by March 26, 2018 (for the ‘182 patent). CHS-1420 (adalimumab (Humira®) biosimilar candidate)
- Reported topline results from a pharmacokinetic bioequivalence (“PK BE”) study comparing CHS-1420 to European marketed Humira. The study met the criteria for clinical PK BE on all prospectively defined endpoints and there were no clinically meaningful differences in the safety profile between the two products.

Financial Highlights for the Third Quarter and year-to-date 2017

Cash used in operations was $41.5 million in the third quarter, down 25% from the $55.6 million used in the second quarter of 2017 and down 43% from the $73.3 million used in the first quarter of 2017. In August 2017, we announced that Temasek, an investment company headquartered in Singapore, plans to invest up to $150 million over two tranches. We received the first tranche of $75 million in aggregate proceeds on August 24, 2017 and issued 6,556,116 shares of common stock at an offer price of $11.4397 per share. The second tranche is projected to be funded following receipt of the U.S. Food and Drug Administration’s marketing approval for the CHS-1701 pegfilgrastim biosimilar product candidate, subject to market pricing and certain closing conditions at that time, including each party’s final approval. Research and development (R&D) expenses for the third quarter of 2017 were $42.6 million, as compared to $64.6 million for the same period in 2016. R&D expenses for the nine months ended September 30, 2017 were $130.9 million, as compared to $195.4 million for the same period in 2016. Decreases in R&D expenses were mainly attributable to the decline and end of clinical activities for CHS-0214, CHS-1420 and CHS-131 during the preceding twelve months. General and administrative (G&A) expenses for the third quarter of 2017 were $14.0 million, as compared to $13.6 million for the same period in 2016. G&A expenses for the nine months ended September 30, 2017 were $56.3 million, as compared to $36.3 million for the same period in 2016. Changes in G&A expenses were mainly attributable to legal and other professional fees to support intellectual property litigation and IPRs, as well as personnel related costs to support CHS-1701 pre-commercial activities in the first six months of 2017. Net loss attributable to Coherus for the third quarter of 2017 was ($59.0) million, or ($1.09) per share, as compared to net income attributable to Coherus of $83.9 million, or $1.67 per share, for the same period in 2016. Cash, cash equivalents and investments in marketable securities – short term totaled $150.1 million as of September 30, 2017, as compared to $118.3 million as of June 30, 2017.

Guidance for the fourth quarter of 2017 and first half of 2018:

CHS-1701 (pegfilgrastim (Neulasta®) biosimilar)

Anticipate resubmitting the BLA in the U.S. mid-first quarter of 2018 subject to meeting with FDA. Anticipate European opinion in the first half of 2018, such timing being dependent upon data requests. Commercial partnering discussions continue to be underway for certain ex-U.S. territories.

CHS-3351 (ranibizumab (Lucentis®) biosimilar)

Prioritizing the development of CHS-3351.

CHS-1420 (adalimumab biosimilar)

Continue to optimize manufacturing.

CHS-0214 (etanercept biosimilar)

Focus on regulatory issues through the first half of 2018. Provide revised guidance on filing of the marketing authorization application in Europe after
CHS-1701 U.S. BLA resubmission. Continue to optimize manufacturing. Targeting immunology (anti-TNF) partnering therapeutic franchise agreement.

CHS-131 central nervous system anti-inflammatory asset

Completing additional animal studies on CHS-131 to further validate its mechanism of action and address drug-derived metabolites. Licensing agreement to follow subject to results.

Cash flow

Anticipate cash use in operations of approximately $35 - $40 million in the fourth quarter of 2017, down approximately $5 million from previous guidance, and $30 - $35 million per quarter in the first half of 2018.

Conference Call Information

When: November 6, 2017 at 4:30 p.m. ET

Dial-in: [phone] (toll free) or [phone] (International)

Conference ID: 99333721

Webcast: http://investors.coherus.com

Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-1420 (adalimumab biosimilar), CHS-0214 (etanercept biosimilar), and CHS-3351 (ranibizumab biosimilar) as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, preclinical and clinical studies, product development, release of data and the potential benefits of its products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ ability to resubmit a BLA in the US and receive marketing approval in Europe for CHS-1710; make advances in the development of CHS-3351; continue to advance its intellectual property strategy and complete partnering agreements for CHS-1420 and CHS-0214; file an MAA for CHS-0214; and complete additional studies and a licensing agreement for CHS-131. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, filed with the Securities and Exchange Commission on November 6, 2017 and its future periodic reports to be filed with the Securities and Exchange Commission.

Enbrel® and Neulasta® are registered trademarks of Amgen Inc.
Humira® is a registered trademark of AbbVie Inc.
Lucentis® is a registered trademark of Genentech, Inc.

Coherus BioSciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)

Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
(unaudited) (unaudited)
Revenue:
Collaboration and license revenue $ - $ 162,835 $ 1,556 $ 189,262

Operating expenses:
Research and development 42,626 64,573 130,901 195,430
General and administrative 13,989 13,645 56,325 36,303
Total operating expenses 56,615 78,218 187,226 231,733
Income (loss) from operations (56,615 ) 84,617 (185,670 ) (42,471 )
Interest expense (2,392 ) (2,420 ) (7,152 ) (5,611 )
Other income (expense), net 14 1,647 3,605 (3,762 )
Net income (loss) (58,993 ) 83,844 (189,217 ) (51,844 )
Net loss attributable to non-controlling interest 4 95 114 428
Net income (loss) attributable to Coherus $ (58,989 ) $ 83,939 $ (189,103 ) $ (51,416 )
Net income (loss) per share attributable to Coherus
Basic $ (1.09 ) $ 1.93 $ (3.68 ) $ (1.25 )
Diluted $ (1.09 ) $ 1.67 $ (3.68 ) $ (1.25 )
Weighted-average number of shares used in computing net
income (loss) per share attributable to Coherus
Basic 54,070,872 43,469,986 51,377,836 41,096,783
Diluted 54,070,872 51,581,298 51,377,836 41,096,783



Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
(in thousands)

September 30, December 31,
2017 2016
(unaudited)
Assets
Cash and cash equivalents $ 135,557 $ 124,947
Investments in marketable securities - short-term 14,493 -
Other assets 39,708 53,538
Total assets $ 189,758 $ 178,485
Liabilities and Stockholders’ Equity
Deferred revenue $ - $ 1,561
Convertible notes 75,944 75,192
Convertible notes-related parties 25,314 25,064
Other liabilities 33,593 57,314
Total stockholders' equity 54,907 19,354
Total liabilities and stockholders’ equity $ 189,758 $ 178,485