SGEN is a strong oncology biotech play. Company reported solid progress for Jun-14 quarter beating on both top and bottom line. Stock has been a favorite of the short community for quite some time and now shows 17m shs shorted which is almost 20% of the float. Price has been considered relatively expensive for quite some time by many which is why the analyst community has kept price targets somewhat low for a bio stock. Current upside to consensus target is <10%. However, company is considered an M&A play by most given it's strong pipeline in cancer. Projected C14 and C15 revenues of $270M and $330m respectively. Wildcard note: Amgen just announced they were shutting down their Seattle presence (old Immunex) and would consolidate in So SF. That puts SGEN in a preferential position for cancer scientists looking NOT to relocate. SGEN has 38 open positions currently: ch.tbe.taleo.net/CH09/ats/careers/jobSearch.jsp?org=SEAGEN&cws=1
Zachs #2 rank report: Seattle Genetics, Inc.’s shares (SGEN) gained 4.8% following the release of second-quarter 2014 results. Seattle Genetics reported second-quarter loss per share of 14 cents, narrower than the Zacks Consensus Estimate of a loss of 22 cents but wider than the year-ago loss of 6 cents per share.
Seattle Genetics, Inc - Earnings Surprise | FindTheBest In the reported quarter, revenues declined 7.1% from the year-ago quarter to $68.3 million. Revenues, however, surpassed the Zacks Consensus Estimate of $65 million. The year-over-year decrease in revenues was mainly due to a decline in collaboration revenues.
The Quarter in Detail
Total revenue comprised product revenues, collaboration and license agreement revenues and royalties. Adcetris, the only marketed product at Seattle Genetics, generated revenues of $44.8 million (in the U.S. and Canada), up 25.3% year over year. This increase was due to higher demand in the approved indications (relapsed Hodgkin lymphoma or relapsed systemic anaplastic large cell lymphoma) as well as physicians’ prescriptions in areas other than these indications.
Collaboration and license agreement revenues and royalty revenues were $16.2 million (down 52.8%) and $7.3 million (up 107.2%), respectively.
Research and development (R&D) expenses increased 2.7% year over year to $53.7 million due to Adcetris’ development activities and higher investment in other antibody-drug conjugate (ADC) programs. Selling, general and administrative (SG&A) expenses increased 8.5% year over year to $25.5 million.
Seattle Genetics and partner Takeda Pharmaceutical (TKPYY) are working on expanding Adcetris’ label. Adcetris is currently in four phase III studies, including AETHERA (post-transplant Hodgkin lymphoma), ECHELON-1 (frontline therapy in patients with advanced classical Hodgkin lymphoma), ECHELON-2 (newly diagnosed CD30-positive mature T-cell lymphoma) and ALCANZA (CD30-positive cutaneous T-cell lymphoma). Top line data from the AETHERA study should be out by Oct 2014. Positive results would allow the company to go ahead with the filing of a supplemental biologics license application in the U.S. in the first half of 2015.
Additionally, Seattle Genetics is developing five antibody-drug conjugates (ADCs) - SGN-CD19A, SGN-CD33A, SGN-LIV1A, ASG-22ME, and ASG-15ME.
Adcetris Revenue Outlook Raised
Seattle Genetics increased its 2014 revenue guidance for Adcetris to the range of $160 million–$170 million (previous guidance: $155 million–$165 million). The company also reduced 2014 R&D expense guidance to the range of $235 million−$250 million.
Seattle Genetics depends on Adcetris significantly for growth. Although Adcetris performed well in the reported quarter, the company expects sales to fluctuate on a quarter-over-quarter basis.
Seattle Genetics currently carries a Zacks Rank #2 (Buy).
Seattle Genetics Initiates Phase 1 Clinical Trial of Antibody-Drug Conjugate SGN-CD70A for Non-Hodgkin Lymphoma and Renal Cell Carcinoma
-Sixth Proprietary ADC in Clinical Development for the Treatment of Cancer-
-Second Proprietary ADC Program Utilizing Newest ADC Technology to Advance into Clinical Trials-
BOTHELL, Wash.--(BUSINESS WIRE)--Aug. 12, 2014-- Seattle Genetics, Inc. (NASDAQ:SGEN) today announced the initiation of a phase 1 clinical trial evaluating SGN-CD70A for CD70-positive relapsed or refractory non-Hodgkin lymphoma (NHL) and metastatic renal cell carcinoma (RCC). SGN-CD70A is a novel antibody-drug conjugate (ADC) targeted to CD70 utilizing the company’s newest ADC technology. The phase 1 trial is designed to assess the safety and antitumor activity of SGN-CD70A.
“CD70 is a very promising ADC antigen, which is highly expressed in both NHL and RCC, and has minimal expression in healthy tissues,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development, at Seattle Genetics. “We are building on the single-agent activity we observed with our former SGN-75 candidate and have designed SGN-CD70A with a goal to have enhanced activity by utilizing our next-generation ADC technology. Our preclinical data demonstrate that this novel ADC is extremely potent in RCC and NHL models, and we are enthusiastic about commencing a clinical trial of SGN-CD70A in patients with a clear need for new therapeutic options.”
Seattle Genetics previously observed single-agent activity, including objective responses, in a phase 1 clinical trial with an initial CD70-targeted ADC called SGN-75 but did not observe enough activity to support further clinical development. To build on that experience, the company developed a next-generation anti-CD70 ADC utilizing its newest technology comprising a highly potent cytotoxic agent, called a pyrrolobenzodiazepine (PBD) dimer, stably linked to a CD70-directed antibody via proprietary site-specific conjugation technology. Preclinical data presented at the 2014 American Association of Cancer Research (AACR) annual meeting demonstrate SGN-CD70A induces targeted cell killing via DNA damage to treated tumors in both RCC and NHL models.
The new SGN-CD70A study is a phase 1, open-label, multi-center, dose-escalation clinical trial. The primary endpoints are to estimate the maximum tolerated dose and to evaluate the safety of SGN-CD70A. In addition, the trial will evaluate the antitumor activity and pharmacokinetics in patients with CD70-positive metastatic RCC or relapsed or refractory NHL, including mantle cell lymphoma and diffuse large B-cell lymphoma. The study is designed to evaluate SGN-CD70A administered every three weeks and will enroll approximately 95 patients at multiple centers in the United States.
ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. This approach is intended to spare non-targeted cells and reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
SGN-CD70A is an ADC utilizing PBD dimers, a class of DNA-crosslinking agents that are significantly more potent than standard chemotherapeutic drugs. Seattle Genetics has been working with PBDs since 2009 under an exclusive research and licensing arrangement with Spirogen Ltd. Over the past five years, Seattle Genetics has selected and optimized specific PBD molecules for its proprietary use in ADCs. In addition, SGN-CD70A employs a novel linker system and proprietary, site-specific conjugation technology (EC-mAb) that allows uniform drug-loading of the cell-killing PBD agent to the anti-CD70 antibody. The ADC is designed to be stable in the bloodstream and to release its cytotoxic agent upon internalization into CD70-expressing cells. SGN-CD70A is Seattle Genetics’ second ADC in clinical development employing the novel PBD technology.
More information about the trial, including enrolling centers, will be available by visiting www.clinicaltrials.gov.
About Seattle Genetics
Seattle Genetics is a biotechnology company focused on the development and commercialization of innovative antibody-based therapies for the treatment of cancer. Seattle Genetics is leading the field in developing antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. The company’s lead product, ADCETRIS® (brentuximab vedotin), is an ADC that, in collaboration with Takeda Pharmaceutical Company Limited, is commercially available for two indications in more than 40 countries, including the U.S., Canada, Japan and members of the European Union. Additionally, ADCETRIS is being evaluated broadly in more than 30 ongoing clinical trials. Seattle Genetics is also advancing a robust pipeline of clinical-stage ADC programs, including SGN-CD70A, SGN-CD19A, SGN-CD33A, SGN-LIV1A, ASG-22ME and ASG-15ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including AbbVie, Agensys (an affiliate of Astellas), Bayer, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com.
Stock continued to rally over the last 2 weeks. Company is truly a head scratcher to most so worth another quick look. Consider the analyst community:
12 analysts have price targets out with a consensus target of $45 and a range of $26-65 which is unusually broad. Ratings are similarly broad: Strong buy 3 Buy 5 Hold 5 Under perform 2
The company is already generating solid revenues. Trailing revenues averaged just shy of $70m per quarter for past 4 quarters. C15 estimates are quite broad as well with a low at $300m and a high of $378m. This represents sales growth of between 10%-40% in C15. Even the most optimistic forecasts do not anticipate profits in C15 which indicates the company is pursuing a much larger opportunity and investors need to decided whether that future is probable and worthy of investment dollars.
The cash situation is positive with a minimal risk of short term dilution given net cash of $350m and operating cash flows of less than $30M used in past 6 months.
Bottom line: Speculative play on pipeline outlined here. M&A opportunity given the number of biopharma companies interested in oncology potential.
Company comments on last earnings conference call relating to product pipeline: Jonathan Drachman - Chief Medical Officer and Executive Vice President of Research & Development Thanks, Todd. I'd like to begin today by spending a few moments discussing the significance of the AETHERA clinical trial that will be unblinded by October.
For patients with Hodgkin lymphoma who have failed frontline curative therapy, there's a high risk that they will relapse and eventually die from disease recurrence, despite advances made in salvage regimens and autologous stem cell transplantation. Many of these patients are young, often in their 20s and 30s, who should have the opportunity to live a long and productive life. AETHERA was designed to test the hypothesis that residual Hodgkin lymphoma might be best treated in the immediate post-transplant setting to delay progression and potentially cure more patients. This trial will provide important information regarding the tolerability of ADCETRIS immediately post-transplant and the potential to extend PFS in patients with Hodgkin lymphoma.
Next, I'd like to address the ECHELON-1 and ECHELON-2 trials, studying the incorporation of ADCETRIS into novel frontline regiments for Hodgkin lymphoma and matured T-cell lymphoma, respectively. When these large global trials were designed, we knew that the combination regimens were tolerable and active, based on high complete response rates. While we still have no information from the ongoing Phase III trials, the duration of responses from the Phase Ib combination trials are encouraging. As Clay mentioned, we have reevaluated our assumptions and have aligned with Takeda to make sure that these trials deliver robust answers to redefined frontline therapy and improve outcomes for patients. During the quarter, we saw strong enrollment to both our frontline trials.
In addition to our ongoing Phase III trials, we continue to evaluate ADCETRIS in earlier lines of therapy for Hodgkin lymphoma, including in combination with Bendamustine in the salvage setting and as a single agent or in combination with dacarbazine in elderly frontline patients. We're enthusiastic about both of these trials and look forward to presenting additional data later this year.
Similarly, there's substantial clinical evaluation of ADCETRIS in both corporate and investigator-sponsored trials and other therapeutic areas. For example, in relapse DLBCL, we're broadly evaluating ADCETRIS as a single agent for patients who express CD30, as well as for patients with undetectable CD30 by immunohistochemistry, and in combination with Rituxan. We're also evaluating ADCETRIS plus R-CHOP in the frontline DLBCL setting. Enrollment is ongoing in all of these areas. We plan to report data later in 2014, which will inform our future plans for ADCETRIS in DLBCL.
Physicians are also eager to explore new potential therapeutic indications and combinations with ADCETRIS as demonstrated in a number of investigator-sponsored trials. For example, several of the ongoing ISTs include trials in graft-versus-host disease, acute myeloid leukemia and in novel frontline regimens. There's also an ECOG trial combining ADCETRIS with the immuno-oncology checkpoint inhibitor, ipilimumab. It's encouraging to see the broad interest in expanded clinical use of ADCETRIS.
Beyond ADCETRIS, we're advancing a strong pipeline of ADCs in multiple ongoing trials that are accruing well. We reported interim data from the -- from SGN-CD19A at ASCO, as Clay described. The activity observed thus far is promising, although we are still early in clinical development. We believe the superficial corneal toxicities observed with SGN-CD19A are manageable and reversible. We are further refining the use of SGN-CD19A, including alternative doses and schedules and the use of prophylactic steroid eyedrops. We are actively considering combination trials, taking advantage of the antitumor activity and limited bone marrow toxicity and neuropathy that has been observed with SGN-CD19A. We plan to report additional data from our Phase I trials later this year.
We also expect to report interim data from our Phase I trial with SGN-CD33A, a CD33-targeted ADC for acute myeloid leukemia later in 2014. AML represents a significant unmet medical need. This is the first clinical trial of an ADC that utilizes our proprietary highly-potent cell-killing agent of PBD dimer and our site-specific conjugation technology.
Our third wholly-owned ADC in clinical trials is SGN-LIV1a. This ADC is targeted to LIV-1, which is expressed on more than 90% of breast cancers. Our ongoing Phase I trial is in multiple subtypes of metastatic breast cancer including triple-negative disease. We anticipate data from this ADC in 2015.
We plan to advance a sixth ADC, SGN-CD70A, in the clinical trials this quarter. This ADC utilizes the same PBD-based ADC technology as SGN-CD33A. CD70 is an attractive ADC target, given its expression profile in hematologic malignancies and renal cell carcinoma, but limited expression in normal tissue. SGN-CD70A has shown impressive activity in preclinical models, and we look forward to initiating the Phase I study.
Our ADC technology is also being evaluated broadly by collaborators. More than 60% of the roughly 40 ADCs in clinical development utilize Seattle Genetics technology. Some recent highlights include: Genentech (Roche) reported interim data at ASCO from 4 programs using our technology, including ADCs targeted to CD22, CD79b, NaPi2b and mesitylene. Genentech also initiated clinical trials with 2 new ADCs using Seattle Genetics technology. AbbVie reported clinical data at ASCO on its EGFR-targeted ADC for glioblastoma. And we achieved a milestone under our Bayer collaboration upon initiation of a Phase I trial of an ADC for solid tumors. It's an exciting time for ADCs with new programs, both by Seattle Genetics and our collaborators, advancing in the clinic. We believe this approach will continue to change the way cancer is treated and that we are well positioned to continue our leadership of the ADC field.
Clay B. Siegall - Co-Founder, Chairman, Chief Executive Officer and President Thanks, Jonathan. Before we open the call to questions, I'd like to summarize our key upcoming milestones: reporting data for multiple ADCETRIS clinical trials, notably top line data from the Phase III AETHERA trial by October; reporting data later this year from our SGN-CD33A trial in AML; and additional data from our SGN-CD19A trials in hematologic malignancies; advancing our sixth clinical stage ADC, SGN-CD70A, into a Phase I clinical trial in the third quarter; and in collaboration with Takeda, obtaining approval for ADCETRIS in additional countries worldwide. We anticipate a busy remainder of 2014, and look forward to keeping you updated on our progress.
Fierce Biotech article last January discusses AbbVie arrangement with Seattle Genetics. Success in this collaboration will add to probability of a buyout so is worth watching as an investor.
AbbVie adds a slate of $255M wagers on Seattle Genetics' 'armed' antibody cancer tech January 8, 2014 | By John Carroll
Whatever AbbVie ($ABBV) learned in the first stages of its collaboration with Seattle Genetics on antibody-drug conjugates must have seriously whetted the pharma company's appetite for more. The Seattle biotech said this morning that AbbVie is paying $25 million upfront and up to $255 million more in milestones for each new target they tackle in a greatly expanded partnership.
Seattle Genetics ($SGEN) is one of the pioneers in the ADC world of "armed" antibodies. Its ADC Adcetris has been approved for two indications and is the subject of a collaboration with Takeda that involves 20 ongoing clinical trials. Partnerships have always played a big role at the company, and Seattle Genetics and Genentech are working together on a variety of programs.
AbbVie initially signed on with Seattle Genetics back in 2011 with an $8 million deal at a time the company was still part of Abbott ($ABT). AbbVie followed up with a $25 million advance last fall and now appears ready to jump in with both feet.
Popularized with the approval of Kadcyla, which Genentech developed with ADC tech from ImmunoGen ($IMGN), the tech ties a highly toxic agent to an antibody designed to precisely deliver its payload right on the cancer target.
"Seattle Genetics continues to advance the field of ADCs through the development and optimization of innovative approaches to empowering antibodies, such as our proprietary EC-mAb and potent PBD-based ADC technologies, both of which are utilized in our pipeline programs SGN-CD33A and SGN-CD70A," said Natasha Hernday, who runs corporate development at Seattle Genetics, in a statement. "By collaborating with companies such as AbbVie, we are expanding the reach of our ADC technology advancements to make novel targeted therapies available for cancer patients."
The AbbVie deal is not the only biopharma company collaborating with SGEN (2013 PR):
Seattle Genetics Enters Into New Antibody-Drug Conjugate Collaboration with Bayer
Seattle Genetics eligible to potentially receive more than $500 million in fees and milestones plus royalties under multi-target deal
BOTHELL, Wash.--(BUSINESS WIRE)--
Seattle Genetics, Inc. (SGEN) today announced that it has entered into a new antibody-drug conjugate (ADC) collaboration with Bayer HealthCare (Bayer). Under the latest relationship, Bayer will pay upfront and option exercise fees of up to $20 million for worldwide rights to utilize Seattle Genetics' auristatin-based ADC technology with antibodies to several oncology targets. Seattle Genetics is also eligible to receive up to approximately $500 million in potential milestone payments, as well as royalties on worldwide net sales of any resulting products under the multi-target collaboration. Bayer is responsible for research, product development, manufacturing and commercialization of all products under the collaboration.
"The significant clinical and preclinical progress across our ADC collaborations, and enthusiasm for our technology as demonstrated by this latest relationship with Bayer, continue to reinforce Seattle Genetics' leadership position in the field," said Natasha Hernday, Vice President, Corporate Development, at Seattle Genetics. "Across internal and collaborator programs, there are more than 15 ADCs in clinical development using our technology, and we have the potential to receive more than $3.5 billion in future milestones plus royalties from these strategic alliances."
"Bayer is committed to translating the science of cancers into effective therapies that can help people with cancer live longer and improve their quality of life," said Prof. Andreas Busch, Member of the Bayer HealthCare Executive Committee and Head of Global Drug Discovery. "Antibody-drug conjugates are promising approaches in oncology which can attack tumor cells in a much more targeted way for cancer patients, such that healthy cells are less severely affected. Antibody-drug conjugates are one of our focus areas in oncology research and we are looking forward to strengthening our portfolio in this area of personalized medicine through the collaboration with Seattle Genetics."
ADCs are monoclonal antibodies that are designed to selectively deliver cytotoxic agents to tumor cells. With over a decade of experience and knowledge in ADC innovation, Seattle Genetics has developed proprietary technology employing synthetic cytotoxic agents and stable linker systems that attach these cytotoxic agents to the antibody. Seattle Genetics' linker systems are designed to be stable in the bloodstream and release the potent cell-killing agent once inside targeted cancer cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing antitumor activity.
Sept 24th Seattle Genetics Highlights Updated Progression-Free Survival and Overall Survival Data from ADCETRIS® (Brentuximab Vedotin) Frontline PTCL Phase 1 Clinical Trial at the ESMO 2014 Congress Wed September 24, 2014 9:00 AM|Business Wire | About: SGEN ADCETRIS in Combination with CHP Chemotherapy Regimen Demonstrates Two-Year Overall Survival Rate of 80 Percent; Estimated Median Progression-Free Survival Not Yet Reached
BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) today highlighted ADCETRIS (brentuximab vedotin) data to be presented at the 2014 European Society for Medical Oncology (ESMO) Congress being held September 26-30, 2014 in Madrid, Spain. The data include a two-year durability analysis from a phase 1 clinical trial of ADCETRIS in combination with chemotherapy for the treatment of newly diagnosed peripheral T-cell lymphoma (PTCL) patients, also known as mature T-cell lymphoma (MTCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).
In the phase 1 trial, newly diagnosed patients received ADCETRIS sequentially with the standard treatment in this setting consisting of cyclophosphamide, doxorubicin, vincristine and prednisone (A+CHOP) or in combination with CHP (A+CHP; removing vincristine from CHOP). In the combination arm, patients received ADCETRIS and CHP every three weeks for six cycles. Patients who achieved at least a partial remission after completing six cycles of combination therapy were eligible to receive continued single-agent ADCETRIS for up to ten additional three-week cycles. The primary endpoints of the trial included defining maximum tolerated dose of ADCETRIS in combination with CHP and evaluating safety. Other endpoints included investigator assessment of response, progression-free survival (PFS) and overall survival (OS).
Peripheral T-cell lymphoma includes a particularly aggressive group of non-Hodgkin lymphomas with relatively few patients achieving long-term remissions, and initial treatment has not changed in decades, typically including a suboptimal regimen of anthracycline-based chemotherapy, said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics (SGEN). Maturing data from this phase 1 trial in patients who have advanced or high-risk disease characteristics demonstrate durable progression-free survival and overall survival rates, supporting our belief that this novel ADCETRIS-containing regimen has the potential to redefine the treatment of frontline PTCL. This hypothesis is being tested in our ongoing phase 3 clinical trial, called ECHELON-2.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6