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Seagen Inc. (SGEN)
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Overall, I thought it was a good earnings call. If SEA-CD30, which I believe is 100% owned, works for pancreatic cancer, it would of course be transformational even for a fairly large, well diversified company like Seagen. Below are comments from Morgan Stanley:
Padcev and Adcetris missed marginally while Tukysa beat. Overall, we saw the quarter as uneventful and expect investors to focus on pipeline opportunities. We look to 2H21 for updates on key programs, in particular EV-103 Cohort K, the MOUNTAINEER trial and potential LIV-1.
Revenues inline, Tukysa beat: 1Q21 total revenues were broadly inline (~$332M vs. ~$336M cons). Quarterly sales of Adcetris and Padcev both missed by ~4% while Tukysa beat ~15%. Mgt. reiterated 2021: Adcetris net product sales are expected to be between $675M-$700M, Padcev between $310M-$325M, and Tukysa between $300M-$315M. Royalty revenues, driven primarily by Takeda's sales of Adectris, are expected to be between $125M-$135M, and collaboration/licenses agreement revenues are expected to be <$20M.
Key takeaways: (1) On Adcetris, mgt. noted that the COVID-19 pandemic continues to adversely impact the HL diagnosis rate, though Adcetris has managed to maintain share in the frontline setting. Mgt. noted that they have received positive feedback from physicians on the 5 year ECHELON data; (2) On Padcev, mgt. expects to present a variety of data at ASCO (see here for all presentations). Of note is an update on EV-103, with durability and long-term outcomes for 1L mUC cis-ineligible patients treated with Padcev plus Keytruda. This readout will be in Cohort A, on which the FDA's original breakthrough therapy designation was based; (3) Separately, mgt. continues to expect to complete enrollment for Cohort K of EV-103 by YE21, and believes filing an sBLA for the frontline mUC setting would be possible in 2022, assuming adequate follow-up; (4) Mgt noted that the update of Padcev's label to include warnings for Stevens-Johnson syndrome or toxic epidermal necrolysis (following cases being observed in the post-marketing observation period) has not been an impediment to adoption by physicians, and has not led to a change in use; (5) On Tukysa, during 1Q21, Tukysa was approved for use in the EU and UK in patients with HER2+ 3L locally advanced or metastatic BC; (6) With regard to label expansion, mgt. expects to complete enrollment for the PhII pivotal MOUNTAINEER trial in patients with metastatic CRC by YE21; (8) On other programs, mgt. continues to enroll a basket trial for ladiratuzumab vedotin in patients with solid tumors, including lung, head and neck, prostate, and esophageal cancers, among others. A PhI trial evaluating SEA-CD30 (in combination with anti-PD-1/chemo) in patients with pancreatic cancer has completed enrollment with initial data expected this year.
Good setup for 2021 and pipeline progress
In our view, there was a lot to like about Seagen’s largely in-line quarter with a slight
EPS miss (-$0.08 vs. cons.) on increased expenses. In the context of an earnings season
that has been characterized by weak results, we'd argue that Seagen held up remarkably
well for a quarter in which the COVID-19 surge pressured the healthcare system as a
whole. Product sales guidance for the three commercial franchises was reiterated, which
we think is beatable, particularly given the lack of negative impact to Padcev from rare
derm adverse events disclosed during the quarter. The Seagen bull story remains intact,
in our view, as the pipeline picks up steam with commercial product #4 on the way in
tisotumab vedotin (TV), under review for metastatic cervical cancer, a 5th (ladiratuzumab
vedotin, LV) in phase 2 development, and label expansion studies under way for Padcev
and Tukysa even as they continue their initial launches. We think these factors,
combined with an emerging early pipeline, profitability on the horizon, and increasing
capacity to supplement the platform with business development combine to give Seagen
a compelling risk/reward profile. Reiterate Buy and $210 PO.
FDA accepted the BLA for TV in cervical cancer with Priority Review, setting a PDUFA
Oct 10th. The agency also accepted (with Priority Review) two sBLAs for Padcev (PDUFA
Aug 17th), one which would convert the initial accelerated approval to regular and one
that would further expand the indication in mUC in the platinum-ineligible population.
Two new studies for Tukysa have initiated: the phase 3 CompassHER2 RD trial
evaluating drug in combo with Kadcyla in the HER2+ adjuvant breast cancer and a phase
2 combination with Herceptin in metastatic solid tumors carrying HER2 alterations.
Sesen Bio (Nasdaq: SESN) is about to explode, get in before August 18, 2021.
• Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)
• Potential for Vicineum to be a best-in-class treatment with projected peak revenue of $1B-$3B globally, $400M-$900M in the US.
• In February 2021, the FDA accepted for filing the Company’s BLA for Vicineum for the treatment of BCG-unresponsive NMIBC and granted the application Priority Review with a target PDUFA date of August 18, 2021.
• Analysts offering 12-month price forecasts for Sesen Bio Inc have a median target of $ 7.00, with a high estimate of $ 8.00 and a low estimate of $ 6.00. The median estimate represents a +162.17% increase from the last price of 2.67.
$SESN $JNJ $RHHBY $RHHBY $ABBV $MRK $NVS $LLY $NVO $AMGN $BMY $AZN $SNY $GSK $GLAXF $GILD $ZTS $MRNA $BAYRY $VRTX $TAK $REGN $BNTX $BIIB $ALXN $BTC $BGNE $SGEN $RPRX $GMAB $HZNP $CVAC $NIO $DOGE.X $ETH.X $MVIS $GME $GNUS $BB $LIZI $JAGX $IDEX $TSLA $PLL $LI $NNDM $BNTX $SNDL $JFU $XPEV
Sorry to be running against the trend, but where Wall Street sees "a miss," I see a company that increased sales revenue by 52 percent (an increase of $104 million) year to year. I think I'll stick around.
"After $600M sales hit from pandemic, Merck's open to 'all forms' of M&A deals, incoming CEO says."
With Merck's sales dragging from the pandemic and the company becoming increasingly reliant on immuno-oncology superstar Keytruda, the pharma giant's executive team unveiled a willingness to flex its M&A muscle.
“We are open to any opportunity to add a meaningful asset,” president and soon-to-be CEO Rob Davis said on a Thursday call with investors. “We are open to all forms of deals and we have the capital” for those deals, he added.
It'll soon have some extra cash on hand, too, thanks to the spinoff of Organon, which is expected to wrap up on June 2. Once the spinoff closes, Merck expects "to receive a special tax-free dividend of $9 billion, which we hope to deploy in a value-enhancing strategic business development opportunity," chief financial officer Caroline Litchfield said....
b of a prelim comments
Strong results with maintained guidance
Seagen’s 1Q results were in line with expectations, which is differentiated among
Biopharma peers, many of which have had much weaker 1Q results. Revenue came in
very close to consensus at $332M (-$4M), led by US Adcetris at $163M (in line). The
Padcev launch was steady despite fears after the reports of rare cases of StevensJohnson syndrome (SJS) and in line with consensus at $70M (-$2M). Tukysa was similarly
in line with consensus $70M for the quarter (+$2M) as uptake continued its strong
trend. Despite the topline's in-line performance, EPS came in below consensus at -$0.67
(-$0.08). Product sales guidance was maintained across the board, which we think is very
achievable given the lower anticipated COVID-19 headwind. With many companies in the
space missing dramatically or even lowering guidance, we thought that Seagen's 1Q
trends were quite good. We continue to be bullish on SGEN shares given the potential of
the early product cycle with Padcev/Tukysa label expansions, potential 4th and 5th
commercial products in tisotumab vedotin (TV) and ladiratuzumab vedotin (LV), and an
emerging early pipeline. Maintain Buy and $210 PO.
How low is this going
Today Company reiterated February 11th guidance for 2021. On that date stock closed at $172.02. and dropped to close at $165.04 the following day. Since then we have declined an additional 25 points although only good news has been announced. The problem is that we are still unprofitable. However we have $2.5 billion in cash and if they wanted they could buy a company with profits or announce a buyback program of their own stock at a 30 pct discount to what Merck paid. I feel your frustrations and wish all longs good luck going forward.
This is pretty much the bottom. Buy as much as you can. Huge potential with amazing growth. 200 by year end.
B of A update on Q results
SGEN US – Rating: BUY (B-1-9) | PO: 210.00 USD | Price: 144.76 USD
After the conservative 2021 guidance provided in the 4Q20 call, we expect 1Q21
earnings to shed light on the pace of commercial progress through 2021 and the
expectations for a smaller impact of COVID-19 as cases decline and greater access to
the healthcare system is restored. We are slightly above consensus on Adcetris at
$169M (+$6M) and Tukysa at $72M (+$4M), while remaining in line on our Padcev
forecast at $72M. We see total revenue above consensus at $338M (+$2M) and EPS at
-$0.56 (+$0.03). With the fourth commercial product, tisotumab vedotin (TV), on track
for approval this year (10/10/21 PDUFA) and coming label expansions to raise the ceiling
for current products, particularly Padcev, we remain bullish on the prospect for longerterm outperformance from Seagen.
• Discussion of the impact of rare occurrences of Stevens-Johnson syndrome (SJS) on
the Padcev trajectory will likely be front and center. Our recent KOL discussion
suggested that physicians are likely to view the benefits of Padcev as outweighing
the risk of SJS given its rare nature and the ability to screen out patients who are at
• We would expect preparations for the recently filed TV launch to be a point of
discussion as well as ladiratuzumab vedotin (LV) and the potential impact of these
two programs on the overall revenue profile.
COVID-19 impact on Adcetris should also be discussed, given the previously noted
impact on diagnosis and also the recent publication of 5-year follow up data in HL.
from b of a this morning. Huge report here are some sgen highlights
With 1Q earnings season ramping up next week, we’ve taken a closer look at the latest
competitive dynamics across the highest-impact oncology markets in Biopharma, ranging
from solid tumors (including lung, RCC, bladder, melanoma, and breast cancers) to
hematology (myeloma, CLL, cHL, DLBCL). Our analysis leverages proprietary IQVIA
BrandImpact market share data (U.S. only) through March, which highlights continued
uptake of I/O agents and targeted therapies across all treatment landscapes. We wouldn’t
say there were any major surprises in the data, but from a new entry perspective, some
agents are tracking above expectations early into their launches, which could prompt
upside both in 1Q but importantly to peak numbers: including 1) Bristol’s Opdivo/Yervoy
in 1L lung (8% 1L share); 2) Seagen’s Padcev in 2L+ bladder (38% share); and 3) Gilead’s
Trodelvy in 2L+ triple negative breast cancer (TNBC), with 35% 2L+ share despite only
being approved for 3L+ patients. Outside of new launches, most of the analyzed markets
remained largely stable throughout the quarter, with continued dominance from Pfizer’s
Ibrance in metastatic breast, Bristol’s Revlimid in myeloma, and AbbVie’s Imbruvica in CLL.
Additionally, strong launches from Seagen’s
Padcev (bladder) and Gilead’s Trodelvy (TNBC) in 2L+ settings bodes well for 1Q numbers.
Our NPV sum of the parts valuation gives a price objective of $210 for SGEN, which
includes $67/share for Adcetris, $47/sh for Padcev (enfortumab vedotin), $34/sh for
Tukysa (tucatinib), $13/sh for tisotumab vedotin, $9/sh for ladiratuzumab vedotin, $1/sh
for collaborations, $14/sh in net cash, and $25/sh for the technology platform. We
assume a WACC of 10% and terminal growth rates for each asset ranging from 0% to
Upside risks are faster than expected launches for Padcev and Tukysa as well as
increased uptake in Adcetris in HL. Successful trials from the pipeline could lead
investors to begin to assign further value to these programs.
Downside risks are successful competitor trials and pricing pressure from less expensive
alternatives. Disappointing uptake of new product launches could result in lower cash
flows and reduced investor confidence in the ADC platform.
update on some first Q numbers
Overview of Bladder Market – Padcev Ramp Continues
Keytruda maintains its lead positioning in the bladder/urothelial market (driven
by 1L), but Astellas/Seagen’s Padcev has remained the leading 2L+ agent as the
strong launch continues. Keytruda continues its uptake in the 1L metastatic bladder
market, with little NT threat. Seagen’s Padcev recently overtook Keytruda as lead 2L+
agent, gaining +7% share in 1Q21
Overview of Metastatic HER2+ Market – Shifting 2L+ Share
Roche’s Herceptin + Perjeta maintains dominant share at ~70% in 1L metastatic
HER2+ pts. We don’t expect much change to the 1L competitive landscape, but the 2L+
market is becoming increasing interesting with growing penetration of Seagen’s Tukysa
(now leading at 27% market share). Tukysa has gaining meaningful share since its April
2020 approval and we expect share gains to accelerate further, taking share largely from
Roche’s Kadcyla; Astra’s Enhurtu is also a competitor
Classical Hodgkin Lymphoma (cHL)
Overview of cHL Market – Mature and Stable 1L Market
Chemotherapy (ABVD) maintains its lead positioning in 1L patients, with Seagen’s
Adcetris + chemotherapy at a consistent 25-30% share of the 1L market. cHL
(classical Hodgkin lymphoma) is the main indication for Seagen’s Adcetris, and we don’t
expect much change to the competitive landscape going forward. Adcetris also dominates
the 2L+ market, with 43% share between Adcetris monotherapy, Adcetris + AVD
chemotherapy, and Adcetris + other chemotherapies
Analyst on CNBC just said he sold all his SGEN and is out of the sector.
I'm encouraged by the muted AH reaction. Let's get through tomorrow, and work on consolidating support in the high 130s.
We will know all we need to know after the market closes tomorrow when SGEN reports.
Just checking on Clay Siegall's piggy bank. April he sold $1,788,979.92 of SGEN stock at $141.96-March he sold $4,277,906.22-Feb. he sold $4,859,976.221-Jan. he sold $5,061,631.32. That's this year only. Look at 2020 and all the previous years. Clay has been milking this stock for 15 years.
Listened to call and thought it was a strong report
The Street sees a miss but revenues were very strong year over year
Take a look after hrs.
Look quick-It's green
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