Synergy Pharmaceuticals (SGYP)

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anonymous

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Synergy Pharmaceuticals (SGYP) have a couple Plecanatide P-III readouts by the end of the year for IBS-C indication. They have a PDUFA date of Jan 29, 2017 for CIC indication and upon approval will be submitting a sNDA for IBS-c. Dolcanatide is their early OIC/UC candidate another uroguanylin analogue.

Plecanatide efficacy and safety profile appears to come out on top when compared to Linzess and Amitiza although no head-to-head studies have been conducted. Rx constipation market has doubled in 2 years and will continue to grow with an aging population. Approximately 5% of the market has been tapped leaving 95% resorting to OTC options. They have 100% interest in their pipeline with all worldwide rights.

Fully diluted: 240M
Cash on Hand: 109M

They are looking at a hybrid sales force with the best talent hired from Shire, Salix, etc.. with several successful launches under their belts. With at least one readout for IBS-C by year's end, PDUFA in Jan 29, 2017 and launch upon approval it appears to be a decent investment with a nice risk/reward profile.

There is always the possibility of a buyout or taking on a partner. Takeda has indicated they have 15-20B for US acquisitions already rumored to be eying Salix from Valeant (for 9.3B). Salix GI assets appear to focus on IBS-D. SGYP appears to be a good fit although Takeda/Sucampo have Amitiza deal which may discourage an acquisition. Similar with Allergan/Ironwood already inked a deal with Linzess. Shire may be a candidate to renew their GI pipeline. Given Synergy picked up Troy Hamilton (Chief Commercial Officer) from Shire early in the process this may have been be the undisclosed plan all along.

Any thoughts?
 








anonymous said:
Synergy Pharmaceuticals (SGYP) have a couple Plecanatide P-III readouts by the end of the year for IBS-C indication. They have a PDUFA date of Jan 29, 2017 for CIC indication and upon approval will be submitting a sNDA for IBS-c. Dolcanatide is their early OIC/UC candidate another uroguanylin analogue.

Plecanatide efficacy and safety profile appears to come out on top when compared to Linzess and Amitiza although no head-to-head studies have been conducted. Rx constipation market has doubled in 2 years and will continue to grow with an aging population. Approximately 5% of the market has been tapped leaving 95% resorting to OTC options. They have 100% interest in their pipeline with all worldwide rights.

Fully diluted: 240M
Cash on Hand: 109M

They are looking at a hybrid sales force with the best talent hired from Shire, Salix, etc.. with several successful launches under their belts. With at least one readout for IBS-C by year's end, PDUFA in Jan 29, 2017 and launch upon approval it appears to be a decent investment with a nice risk/reward profile.

There is always the possibility of a buyout or taking on a partner. Takeda has indicated they have 15-20B for US acquisitions already rumored to be eying Salix from Valeant (for 9.3B). Salix GI assets appear to focus on IBS-D. SGYP appears to be a good fit although Takeda/Sucampo have Amitiza deal which may discourage an acquisition. Similar with Allergan/Ironwood already inked a deal with Linzess. Shire may be a candidate to renew their GI pipeline. Given Synergy picked up Troy Hamilton (Chief Commercial Officer) from Shire early in the process this may have been be the undisclosed plan all along.

Any thoughts?
Click to expand...

"They are looking at a hybrid sales force"
what does this mean
 








From the companies news release:

  • Hired regional sales leaders averaging more than 10 years of GI experience who are driving important pre-launch initiatives and who will support an effective hybrid sales infrastructure that will be deployed at launch.
  • Initiated a partnership with Publicis Touchpoint Solutions, Inc. to implement a cost-effective, flexible hybrid sales force, leveraging highly experienced sales representatives who will be fully dedicated to supporting the launch and adoption of plecanatide.
From what I have read it's a tactic often used when lingering buyouts are on the way. You hire key regional sales leaders/people and outsource the rest. Simplifies buyouts as there isn't as much overhead with a full sales force, and satisfies institutional investors as they need to have full launch capabilities if there isn't a partner or acquisition.
 








anonymous said:
From the companies news release:

  • Hired regional sales leaders averaging more than 10 years of GI experience who are driving important pre-launch initiatives and who will support an effective hybrid sales infrastructure that will be deployed at launch.
  • Initiated a partnership with Publicis Touchpoint Solutions, Inc. to implement a cost-effective, flexible hybrid sales force, leveraging highly experienced sales representatives who will be fully dedicated to supporting the launch and adoption of plecanatide.
From what I have read it's a tactic often used when lingering buyouts are on the way. You hire key regional sales leaders/people and outsource the rest. Simplifies buyouts as there isn't as much overhead with a full sales force, and satisfies institutional investors as they need to have full launch capabilities if there isn't a partner or acquisition.
Click to expand...
 








"regional sales leaders averaging more than 10 years of GI experience who are driving important pre-launch initiatives and who will support an effective hybrid sales infrastructure that will be deployed at launch"

Wow, makes it sound very impressive, but NOT the case in the Western US, especially with RG. The 'leadership' put in place out here was fired, and no not downsized, fired for gross unprofessionalism with reps and customers including several physician complaints. Also, as if discussing Tinder in the field isn't enough there were numerous complaints from customers regarding off label promotion. That was really the straw that broke the camels back! Sorry, no indication of your anti depressant for hot flashes! I know first hand as she told me several stories while on field rides and in offices directly to physicians. Disaster waiting for the next opportunity!

And they are not hiring their own sales force as they continue to say. The contracts have already been signed with Publicis to get weak ass contract reps in there in Q1. Hiring Regional Managers will have no say. The CO will be gone very soon if it ever even makes it to launch! Good luck!
 








In a nutshell the mechanism is described with the following video:

https://www.youtube.com/watch?v=hcctxdxGnqg

Towards the end of the video it takes a little bit of a shot at Linzess for it's non-PH specific mechanism (STa) versus Plencanatide's uroguanylin. The main difference in the studies has demonstrated higher diarrhea rates with Linzess (20%) vs lower rates with Plecanatide.(5-7%).

It appears Synergy may be marketing Plecanatide under the name Trulance or Komfience based upon trademarks they have registered.
 








anonymous said:
"regional sales leaders averaging more than 10 years of GI experience who are driving important pre-launch initiatives and who will support an effective hybrid sales infrastructure that will be deployed at launch"

Wow, makes it sound very impressive, but NOT the case in the Western US, especially with RG. The 'leadership' put in place out here was fired, and no not downsized, fired for gross unprofessionalism with reps and customers including several physician complaints. Also, as if discussing Tinder in the field isn't enough there were numerous complaints from customers regarding off label promotion. That was really the straw that broke the camels back! Sorry, no indication of your anti depressant for hot flashes! I know first hand as she told me several stories while on field rides and in offices directly to physicians. Disaster waiting for the next opportunity!

And they are not hiring their own sales force as they continue to say. The contracts have already been signed with Publicis to get weak ass contract reps in there in Q1. Hiring Regional Managers will have no say. The CO will be gone very soon if it ever even makes it to launch! Good luck!
Click to expand...


That's awful., hopefully he'll get weeded out quickly. I have seen the same in my industry.. very selective references. Publicis numbers will speak for themselves.. I highly doubt the company will get that far and will be aquired before or shortly after approval. Plecanatide efficacy and safety profile numbers speak volumes.. it'll find a place in the market.
 
















Harrisonn Lockridge said:
Is it too late to invest in Synergy Pharmaceuticals, Inc. (SGYP) ??
Click to expand...

This morning jobs report was lackluster as such there could be some weakness in the markets and a further pullback of SGYP and the market in general. Timing in my opinion may be almost perfect.. if you can get in around the $5 range and wait until P-III readouts by end of Dec and PDUFA date in Jan 29 I suspect you will see a decent return. Many analysts are calling for $12-15 price target within a year. I suspect the company is entertaining buyout offers which I suspect will be $12+
 








Plecanatide is an analogue of uroguanylin which is produced by the body. I fully expect IBS-C data will be positive and they will get FDA approval in Jan and begin commercialization soon after. The Publicis reps on the other board have said their start date is Feb 6th.. that being said launch is planned after approval.
 








anonymous said:
This morning jobs report was lackluster as such there could be some weakness in the markets and a further pullback of SGYP and the market in general. Timing in my opinion may be almost perfect.. if you can get in around the $5 range and wait until P-III readouts by end of Dec and PDUFA date in Jan 29 I suspect you will see a decent return. Many analysts are calling for $12-15 price target within a year. I suspect the company is entertaining buyout offers which I suspect will be $12+
Click to expand...

Thanks
 
















anonymous said:
In a nutshell the mechanism is described with the following video:

https://www.youtube.com/watch?v=hcctxdxGnqg

Towards the end of the video it takes a little bit of a shot at Linzess for it's non-PH specific mechanism (STa) versus Plencanatide's uroguanylin. The main difference in the studies has demonstrated higher diarrhea rates with Linzess (20%) vs lower rates with Plecanatide.(5-7%).

It appears Synergy may be marketing Plecanatide under the name Trulance or Komfience based upon trademarks they have registered.
Click to expand...

Call it "crap your brains out" or "Trots" who cares. It's just another entry in the market; no better and no worse than what's there. Better to invest in SunKist.....prunes work on everybody and a lot cheaper.
Publicis is a joke. A bunch of retreads and losers. That's a very telling sign as to the confidence Synergy has in their glorified laxative.
 








anonymous said:
Synergy Pharmaceuticals (SGYP) have a couple Plecanatide P-III readouts by the end of the year for IBS-C indication. They have a PDUFA date of Jan 29, 2017 for CIC indication and upon approval will be submitting a sNDA for IBS-c. Dolcanatide is their early OIC/UC candidate another uroguanylin analogue.

Plecanatide efficacy and safety profile appears to come out on top when compared to Linzess and Amitiza although no head-to-head studies have been conducted. Rx constipation market has doubled in 2 years and will continue to grow with an aging population. Approximately 5% of the market has been tapped leaving 95% resorting to OTC options. They have 100% interest in their pipeline with all worldwide rights.

Fully diluted: 240M
Cash on Hand: 109M

They are looking at a hybrid sales force with the best talent hired from Shire, Salix, etc.. with several successful launches under their belts. With at least one readout for IBS-C by year's end, PDUFA in Jan 29, 2017 and launch upon approval it appears to be a decent investment with a nice risk/reward profile.

There is always the possibility of a buyout or taking on a partner. Takeda has indicated they have 15-20B for US acquisitions already rumored to be eying Salix from Valeant (for 9.3B). Salix GI assets appear to focus on IBS-D. SGYP appears to be a good fit although Takeda/Sucampo have Amitiza deal which may discourage an acquisition. Similar with Allergan/Ironwood already inked a deal with Linzess. Shire may be a candidate to renew their GI pipeline. Given Synergy picked up Troy Hamilton (Chief Commercial Officer) from Shire early in the process this may have been be the undisclosed plan all along.

Any thoughts?
Click to expand...

One.... You're full of shit. Gotta Love you guys that like to hear themselves talk and pretend they know what they're talking about. This crap is a desperate attempt of Synergy to make a quick buck on somebody else's back.
 
























anonymous said:
"They are looking at a hybrid sales force"
what does this mean
Click to expand...
what it means is that synergy doesn't have enough confidence on their constipation drug to hire their own sales people. They're praying it makes enough of a splash to be acquired.
Say away from this dog. The only way it will get any traction is through pricing, and you know what that means.
 








anonymous said:
what it means is that synergy doesn't have enough confidence on their constipation drug to hire their own sales people. They're praying it makes enough of a splash to be acquired.
Say away from this dog. The only way it will get any traction is through pricing, and you know what that means.
Click to expand...


Not quite. It's all due to lack of infrastructure. Reps will be rolled over into Synergy employees by start of 2018.
 
























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