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This is amazing. An over the counter stock at seven cents and you all talk like this is a major company about to do big things.
I own a few shares, but I am also a realist, and I think this stock is history.
Sorry about that.
From 20 to 50 is 30. Half pull back would be 15. 50 minus 15 would bring us to 35. Seems that is where we are at.
Thanks buddy
Normally a stock that doubles (going from $.24 to $.50), retreats 50% of the move. That would be to around $.36.
Do we move up from here or down?
Maybe next week will have some answers. We'll see.
You don't understand. I am not wishing for IPIX to fail. After all I own stock in this company.
I'm just trying to keep it real as to the possibility of a penny stock on the OTC board achieving great heights in the stock world.
Lottery stock do win occasionally. Maybe this will be one of the times it happens.
Realty check in order. Be careful out there is all I'm saying.
Rose colored glasses? Realty check?
I agree. Time to put this stock on the back burner until something shakes out.
There are others that are here, just nothing to say at the moment.
I hope everyone's dream comes through on this investment. I too, have a few shares.
I want to caution everyone to the reality of the moment: IPIX is a penny stock. It is not listed on any major exchange and is a very small player.
Could it explode like everyone hopes? Possibly. But the realty is that a stock that is $ .23 $ .25 is there because of the value inherited in the stock.
Supply & demand. The stock goes up when buyers think there is an upside and the stock goes down when there are no buyers or no one wants to own the stock.
IPIX is a lottery stock. The odds of success are about the same as buying a lottery ticket in my opinion.
Again, I own a few thousand shares because one of your posters encouraged me to have a few shares. I bought this stock as a purely lottery pick, not as an investment, long term, with dividends and splits.
I wish you all the best of luck. I've been in stocks for many many years and have seen many "IPIX" stocks. I have been in some that went to zero.
Not saying IPIX will go to zero but I think the possibility of this stock going to $5.00 or zero, the odds favor a penny stock on the OTC board going to zero.
It is on the OTC board because it belongs there, according to it's history and it's investors.
Careful here. Zero is even cheaper
Yes, you will be filthy rich, but what if it goes to zero?
I will still be more comfortable at $2.00 than at $ .02
Be careful. OTC stocks can be tricky. No guarantees here.
Company does not have much money. They either have to partner up or sell more stock. Plan for the worst and hope for the best.
Good luck
I wouldn't be a buyer if it goes into the teens again, that would mean it is going down from weakness.
I would be a buyer on the up side. If the stock goes to $2.00 or $3.00 then there is a reason for that move and I would be a buyer then, knowing the stock is on a solid footing.
Liberty Global to Leverage the Pareteum Experience Cloud in New Pan-European Voicemail Platform
8:30 am ET June 17, 2020 (PR Newswire) Print
Pareteum Corporation (Nasdaq: TEUM), a global cloud communications platform company, announced today that it has been selected by Liberty Global, a multinational telecommunications company, to build a pan-European Voicemail platform.
https://mma.prnewswire.com/media/435599/Pareteum_Logo.jpg
Leveraging the Pareteum Experience Cloud Voicemail solution, Liberty Global's new platform will be available to its entire European customer base.
Liberty Global is one of the world's leading converged video, broadband, and communication companies, with headquarters in London, Amsterdam, and Denver. They have operations in several European countries under the consumer brands Virgin Media, Telenet, and UPC.
The Pareteum Experience Cloud Voicemail solution is a multi-tenant, API-driven voicemail offering that supports over 100 features, settings, and options, enabling rich customer experiences.
The partnership provides Liberty Global with one pan-European, geo-redundant voicemail platform capable of serving millions of customers across Europe and supporting the continent's many languages and time zones. Additionally, the Pareteum Experience Cloud Voicemail solution has been integrated with IMS, enabling both fixed and mobile customers to use the same voicemail environment.
The solution is based on the Pareteum Experience Cloud architecture. This means that other Pareteum offerings, such as Interactive Voice Response (IVR) and Missed Call Alert, can be easily deployed to further expand Liberty Global's new platform in the future.
"The flexibility, scalability, and cost effectiveness of our Voicemail solution offers many advantages to telecom operators around the world," said Bart Weijermars, Pareteum's interim CEO. "I see the delivery of our Voicemail solution as the next step in our long-standing relationship with Liberty Global."
On April 23, 2020, Liberty Global migrated the first users to the platform.
guess not
Nice bump back today. More to come tomorrow?
Not even half the trading day has gone by and over 22 millions shares have traded.
Looks like TEUM will be able to stay on NASDAQ with compliance.
What will TEUM open at tomorrow?
Pareteum Secures $17.5 million in Financing to Position for Future Growth
PR Newswire•June 9, 2020
NEW YORK, June 9, 2020 /PRNewswire/ -- Pareteum Corporation (Nasdaq: TEUM), (the "Company"), a global cloud communications platform company, today announced that the Company closed the issuance of $17.5 million in Senior Secured Convertible Notes, with warrants, to an institutional investor. The net proceeds to the Company will be $14 million. The net proceeds from the financing will be used for working capital, general corporate purposes, growth initiatives and new product development.
Up after hours big time
Bausch Health Completes Acquisition Of Certain Assets Of Synergy Pharmaceuticals Inc.
[PR Newswire]
PR Newswire•March 6, 2019
LAVAL, Quebec, March 6, 2019 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") announced today that the Company has completed the acquisition of certain assets of Synergy Pharmaceuticals Inc. (SGYP) ("Synergy") for a cash purchase price of approximately $195 million and the assumption of certain assumed liabilities, pursuant to the terms of the stalking horse asset purchase agreement previously entered into with Synergy and following approval by the U.S. Bankruptcy Court for the Southern District of New York (the "Bankruptcy Court") on March 1, 2019.
"We are excited to welcome new team members from Synergy to join our Salix Pharmaceuticals business, a leader in gastroenterology. We believe that adding TRULANCE® to our portfolio and dolcanatide to our early pipeline will organically grow this core business for the Company," said Joseph C. Papa, chairman and CEO, Bausch Health. "In 2019, Bausch Health will continue pivoting to offense with research investments and strategic acquisitions and alliances in our core businesses – therapeutic areas that will both drive Company growth and where we can have the biggest impact on the lives of the patients we serve."
Synergy's flagship product, TRULANCE® (plecanatide) is a once-daily tablet approved for adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), and its investigational compound, dolcanatide, is an incremental peptide with established proof-of-concept studies in multiple GI conditions.
Wachtell, Lipton, Rosen & Katz served as legal advisor to Bausch Health in this transaction.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.
Forward-looking Statements
This news release may contain forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in the Company's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference and the following factors: the possibility that the anticipated benefits of the transaction are not realized when expected or at all, including as a result of the impact of, or problems arising from, the integration of the acquired assets of Synergy; the possibility that the transaction may be more expensive to complete than anticipated; diversion of management's attention from ongoing business operations and opportunities; exposure to potential litigation; and potential adverse reactions or changes to business or employee relationships, including those resulting from the bankruptcy proceedings of Synergy or announcement or completion of the transaction. In addition, certain material factors and assumptions have been applied in making these forward-looking statements, including that the risks and uncertainties outlined above will not cause actual results or events to differ materially from those described in these forward-looking statements. The Company believes that the material factors and assumptions reflected in these forward-looking statements are reasonable, but readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.
IT'S OVER!!
Synergy Pharmaceuticals Confirms Bausch Health as Successful Bidder for Its Business Assets
[PR Newswire]
PR Newswire•February 26, 2019
NEW YORK, Feb. 26, 2019 /PRNewswire/ -- Synergy Pharmaceuticals Inc. (SGYP) (the "Company" or "Synergy"), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today confirmed that the previously announced agreement with Bausch Health Companies Inc. has been designated as the highest and best offer for Synergy's assets, including all rights to TRULANCE® (plecanatide), dolcanatide and related intellectual property. The auction scheduled for February 26, 2019, did not proceed, as no party submitted a higher and better bid in accordance with the bidding procedures established by the U.S. Bankruptcy Court for the Southern District of New York. Synergy currently expects the agreement with Bausch Health will be approved by the Bankruptcy Court on March 1, 2019, and that the proposed sale will be completed shortly thereafter.
Synergy on December 12, 2018, initiated voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of New York to facilitate a sale and address its debt obligations. Additional information about Synergy's Chapter 11 cases can be found at https://cases.primeclerk.com/Synergy.
Synergy is advised in this transaction by Skadden, Arps, Slate, Meagher & Flom LLP, Sheppard, Mullin, Richter & Hampton LLP, Centerview Partners and FTI Consulting.
Forward-Looking Statements
This press release contains forward-looking statements, which are based on our current expectations, estimates, and projections about the businesses and prospects of the Company and its subsidiaries ("we" or "us"), as well as management's beliefs, and certain assumptions made by management. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," "may," "should," "will" and variations of these words are intended to identify forward-looking statements. Such statements speak only as of the date hereof and are subject to change. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason. These statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Forward-looking statements discuss, among other matters: our expectation that the Bankruptcy Court will approve the previously announced agreement with Bausch Health on March 1, 2019; the Company's ability to complete the proposed sale to Bausch Health in the near term; our financial and operational results, as well as our expectations for future financial trends and performance of our business in future periods; our strategy; risks and uncertainties associated with Chapter 11 proceedings; the negative impacts on our businesses as a result of filing for and operating under Chapter 11 protection; the time, terms and ability to confirm a Chapter 11 plan of reorganization for our businesses; the adequacy of the capital resources of our businesses and the difficulty in forecasting the liquidity requirements of the operations of our businesses; the unpredictability of our financial results while in Chapter 11 proceedings; our ability to discharge claims in Chapter 11 proceedings; negotiations with the holders of our indebtedness and our trade creditors; risks and uncertainties with performing under the terms of the debtor-in-possession ("DIP") financing arrangements and any other arrangement with lenders or creditors while in Chapter 11 proceedings; the Company's ability to operate our businesses within the terms of our respective DIP financing arrangements; the forecasted uses of funds in the Company's DIP budgets; our ability to conduct business as usual in the United States and worldwide; our ability to continue to serve customers, suppliers and other business partners at the high level of service and performance they have come to expect from us; our ability to continue to pay suppliers and vendors; our ability to fund ongoing business operations through the applicable DIP financing arrangements; the use of the funds anticipated to be received in the DIP financing arrangements; the ability to control costs during Chapter 11 proceedings; the risk that our Chapter 11 Cases may be converted to cases under Chapter 7 of the Bankruptcy Code; the ability of the Company to preserve and utilize the NOLs following Chapter 11 proceedings; the Company's ability to secure operating capital; the Company's ability to take advantage of opportunities to acquire assets with upside potential; the Company's ability to execute on its strategic plan to evaluate and close potential M&A opportunities; our long-term outlook; our preparation for future market conditions; and any statements or assumptions underlying any of the foregoing. Such statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Accordingly, actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors.
Important factors that may cause such differences include, but are not limited to, the decisions of the Court; the Company's ability to meet the closing conditions of the agreement with Bausch Health; negotiations with our debtholders, our creditors and any committee approved by the Court; negotiations with lenders on the definitive DIP financing documents; the Company's ability to meet the closing conditions of its DIP financing; the Company's ability to meet the requirements, and compliance with the terms, including restrictive covenants, of their respective DIP financing arrangements and any other financial arrangement while in Chapter 11 proceedings; changes in our operational or cash needs from the assumptions underlying our DIP budgets and forecasts; changes in our cash needs as compared to our historical operations or our planned reductions in operating expense; adverse litigation; changes in domestic and international demand for TRULANCE; our ability to control operating costs and other expenses; that general economic conditions may be worse than expected; that competition may increase significantly; changes in laws or government regulations or policies affecting our current business operations and, as well as those risks and uncertainties disclosed under the sections entitled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Forms 10-Q filed with the Securities and Exchange Commission ("SEC") on May 10, 2018, August 8, 2018 and November 9, 2018 and Form 10-K filed with the SEC on March 1, 2018, and similar disclosures in subsequent reports filed with the SEC.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy's proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate - dolcanatide. For more information, please visit www.synergypharma.com.
Cision
Cision
View original content:http://www.prnewswire.com/news-releases/synergy-pharmaceuticals-confirms-bausch-health-as-successful-bidder-for-its-business-assets-300802756.html
Synergy Pharmaceuticals Wins Approval for Bankruptcy Loan
Drugmaker can draw down remainder of $155 million financing package over protests from shareholders
By Tom Corrigan
Feb. 22, 2019 5:48 p.m. ET
Synergy Pharmaceuticals Inc. won court permission to draw down the remainder of a $155 million bankruptcy financing package, overcoming roadblocks imposed by a newly empowered committee of shareholders.
Synergy Shareholders Legal Fight Starts To Pay Off
Jan. 17, 2019 2:15 PM ET|
8 comments
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About: Synergy Pharmaceuticals, Inc. (SGYP)
Jose Solorio
Long/short equity, special situations, healthcare, options
(1,126 followers)
Summary
A self-funded ad-hoc committee was formed in early December by shareholders to protest one of the most unfounded bankruptcy stories in recent history.
Shareholders have also petitioned the US Trustee to appoint an official equity committee. A letter to that regard was sent on December 26 to the US Trustee.
On January 14, the US Trustee advised that they will solicit interest on the formation of an equity committee.
On top of that, CRG, with their predatory like practices, refused to renegotiate a term loan with Synergy. Instead, they wanted Synergy to file for bankruptcy to accelerate very generous prepayment penalties (which will be challenged by shareholders), entrance and exit fees for a Debtor in Possession finance package, and interest rates.
Finally, Bausch Health put on a stalking horse bid price that barely covered the severance and the senior secured creditors. By doing so, they were hoping to expedite the bankruptcy process by bypassing the possibility of a shareholder committee being formed as I will explain below.
Shareholders are last in line
The reason why many times in bankruptcy shareholders are wiped down is that it's too difficult to organize shareholders in a large, fast and efficient manner. Shareholders are always spread out so thin that they barely ever have a chance to mount a significant defense to protect their interests. As such, management, creditors, unsecured creditors, the DIP lender, etc. will all feast at their expense. Usually, here's how money is distributed in a bankruptcy.
Food Chain of Bankruptcy
DIP Lender
Secured Lenders
Unsecured Lenders
Unsecured Claims
Shareholders
To the extent that there's money leftover, there will be a distribution for the rest of shareholders.
How to protect the interest of shareholders in Bankruptcy Court
The first question that any investor has to ask is whether there's a significant likelihood of recovery. This has to be based on facts and information. If there's a significant chance, then you should fight back. In order to fight back in bankruptcy, there are 3 possible avenues:
A self-funded Ad-Hoc Committee.
A US Trustee appointed Official Equity Committee.
A court-appointed Official Equity Committee.
An Ad-Hoc committee is a self-funded effort where a group of investors or a single large investor hires a law firm to protect their interests on the court. This can be a very expensive endeavor since legal fees in court quickly pile up. Synergy Investors through a GoFundMe campaign raised over $34,000 to hire Cole Schotz and quickly get their defense started. Then they asked Cole Schotz to petition the US Trustee on their behalf to appoint an Official Equity Committee.
The Role of Official Committees in Bankruptcy
When a bankruptcy is filed there are millions of dollars in legal fees involved. When a lender lends money, they don't lend money to spend millions trying to get it back. As such, to protect the interests of the different parties, the court tends to appoint Committees whose legal costs will run as part of the costs of the Debtor in Bankruptcy court.
When 1) there's a significant chance that money can be recovered for shareholders and 2) that if no appointment of an Official Equity Committee will significantly damage the interests of shareholders because no alternative legal defense is available, then the US Trustee is more likely to appoint an Official Equity Committee.
Significant Resources at their Disposal
Once an official Equity Committee of shareholders is formed, shareholders have equal resources to defend their interests against all the other 4 parties previously mentioned in the food chain of bankruptcy.
How to participate
You should receive through your brokerage a letter asking you to fill out a form. Though participating in an Official Equity Committee sounds very interesting, the commitment shouldn't be taken lightly. Being a shareholder shouldn't be the only reason you want to join. You should want to join because you have significant expertise to add to the process. For example, if you have a healthcare background, have significant experience in litigation, deal-making, and finance. Deep understanding of SEC filings and other things are also required. Also the ability to read thousands of pages in a very short period of time. If you can't fulfill the previous requirements it's best to let others take the lead.
Click here to download the form.
Deadline
In order to be able to participate on the Equity Committee, you have to fill out the form and send it by January 25.
Ad-Hoc Committee
There is still time to fill out the form which helped petition the US Trustee and which has compiled the information of over 700 shareholders who are part of the resistance and through which efforts, an Official Equity Committee is likely to be formed. They have launched a NewGoFundMe as well to cover the rest of the legal fight until the Official Equity Committee appointment arrives.
Cole Schotz
If you get to serve on the Official Equity Committee, please don't forget that Cole Schotz has financed close to 65k in legal fees to help protect shareholders against other parties (this is the difference between the retainer and actual legal work performed). Cole Schotz is one of the best bankruptcy law firms in New York. Also, consider that in such a short bankruptcy case, switching law firms from the Ad-Hoc Committee into the Official Equity Committee could significantly slow the progress. A significant amount of time and resources is needed to get up to speed with court filings.
Summary
Things are looking up for Synergy Shareholders. Ten years ago I was part of the Fremont General bankruptcy. Shares traded all the way down to .015 cents. However, we had an Official Equity Committee and we were able to put up a significant defense and reorganize. When we came out of bankruptcy we traded as high as $1.40 two months later. Where there's a will, there's a way and Synergy shareholders have definitely proved to be resilient and their efforts will pay off.
The following are the motions filed by Cole Schotz on behalf of Ad-Hoc Committee of shareholders:
Objection to DIP Financing Motion
Objection to Debtor's Bidding Procedures
Objection to Debtor's Bidding Procedures 2
Objection to Debtor's Dip Financing Motion
Objection to Key Employee Incentive Plan
Synergy Pharmaceuticals (SGYP) shareholders should greatly rejoice on the news that the US Trustee is soliciting interest for the formation of an Official Committee of Equity Holders. This is bullish news for any shareholder who is still holding onto their investment in Synergy. I would explain what steps you need to take in order to apply to be part of it and whether you should even consider applying to it.
Shareholders Getting wiped in Bankruptcy
A common myth in bankruptcy is that shareholders always get wiped out and they lose everything. While sometimes this is true, companies file for bankruptcy for a variety of reasons. For example, in Synergy's case, I believe the company filed for bankruptcy in order to avoid civil liability and release its directors from claims. This can be better understood by looking at the reorganization plan filed with the court on December 21, 2018. In other cases, companies file for bankruptcy to negotiate better terms with a lender and to restructure their operations and pension obligations.
CRG, Bausch Health, Centerview and Synergy covering their backs
What has been evident since the beginning of this bankruptcy case is that all the parties were working against the interest of shareholders. For example, it seems that when management was unable to find an offer that would make their options worth a significant amount of money (most of the senior management team had options valued above $2), they decided instead to file for bankruptcy and in the process negotiate a $15 million severance plan for them that was set aside specifically for them out of the stalking horse bid. They also proposed a KEIP (Key Employment Incentive Plan) that rewarded them for selling the company at a higher price than their artificially created low price. The combined bonuses made up for a good portion of their lost options.
Bought themselves another week????
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) Files An 8-K Entry into a Material Definitive Agreement
By
ME Staff 8-k -
December 6, 2018
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01Entry into a Material Definitive Agreement.
On December5, 2018, Synergy Pharmaceuticals Inc. (the “Company”) and certain of its subsidiaries entered into an Amendment to Limited Forbearance Agreement (the “Amendment”) with CRG Servicing LLC, as administrative agent and collateral agent (in such capacities, the “Agent”) and the lenders party thereto (collectively, the “Lenders”), which amended that certain Limited Forbearance Agreement, dated as of November21, 2018 (as amended by the Amendment, the “Forbearance Agreement”), among the Company, the Agent and the Lenders, with respect to the Company’s Term Loan Agreement, dated as of September1, 2017 (as amended, modified or otherwise supplemented from time to time, the “Term Loan Agreement”), with the Agent and the Lenders. to the Amendment, amongst other things, the Forbearance Period (as defined in the Forbearance Agreement) has been extended to December14, 2018 (11:59 p.m.Central time).
The foregoing is a summary of the material terms of the Amendment. Investors are encouraged to review the entire text of the Amendment, a copy of which is filed as Exhibit10.1 to this report and incorporated herein by reference.
Item 2.04Triggering Events that Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement.
On December5, 2018, the Company notified the Lenders of a default under the Term Loan Agreement due to the failure of the Company, as of December5, 2018, to maintain the minimum liquidity amount (“Liquidity Covenant Default”) required under Section10.02 of the Term Loan Agreement. In addition, as referenced in the Forbearance Agreement, the Company was in default under the Term Loan Agreement due to the failure of the Company, beginning on October30, 2018, to maintain the average market capitalization (“Market Capitalization Default”) required under Section10.01 of the Term Loan Agreement. to the Forbearance Agreement, the Lenders agreed with the Company not to take action on account of either the Liquidity Covenant Default or the Market Capitalization Default, to accelerate the obligations of the Company under the Term Loan Agreement or otherwise exercise their default rights and remedies through December14, 2018.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
SYNERGY PHARMACEUTICALS, INC. Exhibit
EX-10.1 2 a18-41215_1ex10d1.htm EX-10.1 Exhibit 10.1 AMENDMENT TO LIMITED FORBEARANCE AGREEMENT This AMENDMENT TO LIMITED FORBEARANCE AGREEMENT is made as of December 5,…
To view the full exhibit click here
About Synergy Pharmaceuticals Inc. (NASDAQ:SGYP)
Synergy Pharmaceuticals Inc. (Synergy) is a biopharmaceutical company focused on the development and commercialization of gastrointestinal (GI) therapies. The Company’s GI platform includes two lead product candidates: plecanatide and dolcanatide. It is engaged in the discovery, research and development involving uroguanylin analogs for the treatment of functional GI disorders and inflammatory bowel disease. Plecanatide is the Company’s uroguanylin analog being evaluated for use as a once-daily tablet for two functional GI disorders, chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Plecanatide is a 16-amino acid peptide that is structurally identical to uroguanylin with the exception of a single amino acid change. Dolcanatide is also its uroguanylin analog being explored for inflammatory bowel disease (IBD). Dolcanatide is designed to be an analog of uroguanylin with resistance to standard digestive breakdown by proteases in the intestine.
Can Synergy Survive This Crisis?
Oct. 31, 2018 1:20 PM ET
About: Synergy Pharmaceuticals, Inc. (SGYP)
John Engle
Value, special situations, Deep Value, Growth
LinkedIn
Summary
On October 25th, Synergy announced that sales of constipation drug Trulance were growing slower than anticipated, raising the risk of breaching liquidity and revenue covenants of a private loan.
Lender CRG has been accommodating to date, allowing multiple amendments of the loan terms over the past year, but Synergy states it is unwilling to budge.
If CRG refuses to amend the loan further, Synergy could be forced into insolvency; high bankruptcy risk is already priced into the stock.
It appears to be in CRG’s interest to find an accommodation; forcing Synergy to go under would likely cause the lender both monetary and reputational losses.
While odds are on a deal, any play now would be pure speculation; a successful amendment would end the crisis and launch the stock upward, while failure could drive the stock to zero.
We have been following the trials and tribulations of Synergy Pharmaceuticals (SGYP) for a while now. In our most recent research note, we discussed how recent formulary wins and increasing prescription counts for constipation drug Trulance appeared to be setting the company up to turn the corner in 2019.
In May, under the leadership of new CEO Troy Hamilton, Synergy embarked on a strategic review aiming to turn around the flagging efforts to commercialize Trulance, a drug approved for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation. At first, it appeared to be working, with the company dragging down its unsustainably high cash burn and seeing important formulary wins. The latest news is evidence that the turnaround was not quite so successful as we had surmised.
On October 25th, Synergy dropped a bombshell announcement: The company may not be able to meet the minimum liquidity covenant of a private loan and, if it cannot renegotiate the terms, it could be forced into bankruptcy.
This is a disastrous turn of events by any measure, but is it the end for Synergy? The market is now pricing the stock as if it's at death’s door. On Thursday, October 24th, shares closed at $1.40. At the time of writing on October 30th, shares had fallen below $0.40.
Let’s take a look at what has befallen the struggling pharmaceutical company, and whether there is hope yet to escape the current catastrophe.
An Accommodating Lender, Up To A Point
The provider of Synergy's debt facility is CRG, a lender specializing in the healthcare sector. When CRG inked the deal with Synergy in September 2017 to provide $300 million in non-dilutive debt financing, the lender had this to say:
We are excited for the opportunity to support Synergy at this important stage in the commercialization of TRULANCE. As part of our investment process at CRG, we performed extensive due diligence on TRULANCE, the market opportunity and Synergy’s overall business and commercial strategy. The results confirmed that TRULANCE has a substantial opportunity to serve the GI community and that there is tremendous potential to add significant value to the Company. This transaction demonstrates our confidence in Synergy’s product, commercial strategy and its team’s ability to optimize TRULANCE and successfully capitalize on this large and growing market.
In the year following the closing of the financing deal, Synergy struggled to gain traction with Trulance at the pace expected. With cash burn running high and prescription growth not accelerating as anticipated, Synergy sought alterations to the initial financing deal on multiple occasions. CRG proved quite accommodating on this score, as Seeking Alpha’s Jose Solorio pointed out last month:
Originally Synergy had secured a $300 million loan agreement from CRG. Under the original agreement Synergy needed to have $128 million in cash and cash equivalents on January 31, 2018, to access an additional $100 million in funding. The company in order to stay compliant had to hit at least $100 million in net Trulance sales for 2018.
Instead of taking the $100 million which would have resulted in an additional $9 million in interest payments for 2018, Synergy changed the terms of the agreement for a total commitment of a $200 million loan and a $61 million net Trulance sales target. The additional $100 million to be borrowed was to be drawn on 3 tranches: $25 million, $25 million and $50 million on or before June 30, 2018, September 30, 2018, and December 31, 2018...
CRG has proved to be extremely flexible in working around Synergy's needs by amending the first $25 draw date to August 29 in exchange for a $500,000 penalty if/when the money was borrowed. The other draw dates were to remain the same: $25 million on September 30, 2018, and $50 million on December 31, 2018.
CRG has also taken a more proactive role in Synergy’s strategy, appearing on stage with management at its latest annual meeting.
But it appears that CRG’s patience with Synergy is now running thin, if not run out entirely.
Breach Of Covenants Loom Large
Synergy’s update on October 25th suggests that CRG is no longer willing to make further concessions to the struggling pharmaceutical company:
The Company has been unable to further amend the agreement with respect to the financial and revenue covenants, and the Company has decided to forego drawing down on any additional amounts pursuant to its term loan agreement. Moreover, the Company’s term loan agreement contains a minimum liquidity covenant that absent relief from CRG may not be satisfied.
Synergy claims to be in ongoing discussions with CRG in hopes of amending the covenants further in order to avoid a liquidity crisis that could force a bankruptcy:
Synergy is continuing discussions with CRG for covenant relief and in parallel the Company is currently pursuing financing alternatives that better align with its business, but there is no assurance that the Company can secure CRG’s consent or otherwise obtain any such financing on commercially reasonable terms, in which case the Company could default under the term loan agreement and may have to pursue or otherwise accelerate strategic alternatives, including the possibility of seeking bankruptcy protection to protect stakeholder value in the event other options are not reasonably executable.
Synergy is also at risk of breaching a revenue covenant, which could further add to penalties the company could be forced to pay CRG (and could exacerbate default risk). Per the October 25th update:
TRULANCE uptake in 2018 has been slower than anticipated due to a highly competitive market access environment and slower than anticipated overall market growth. As a result, based on the Company’s current updated forecasts, Synergy is projecting TRULANCE total net sales for 2018 to be between $42.0 million to $47.0 million, which would be below the minimum revenue covenant of $61.0 million set forth in its term loan agreement with CRG. Under the terms of the agreement, Synergy will be required to repay principal and pay prepayment penalties in an amount equal to $38.0 million to $51.0 million if total net sales fall within the expected range noted above. Such principal repayment and prepayment penalties will be due no later than March 31, 2019. As previously announced, the Company has continued to evaluate opportunities to reduce cash expenditures to better align with anticipated revenues and available capital.
These are serious issues and could result in Synergy going under. It is thus unsurprising that the stock is trading with a market capitalization of less than $100 million.
Will CRG Extend A Lifeline?
The big question, indeed the existential question, facing Synergy is this: Will CRG allow it to renegotiate a new deal? It seems as if Synergy is pushing hard, as evidenced by its making the situation public. Moreover, Synergy made another, seemingly unnecessary, admission in its October 25th update:
The Company held in-depth discussions with numerous potential counterparties regarding various strategic alternatives during this process. To date, the offers received to acquire Synergy have been significantly below the Company’s current market value, and it has been unable to consummate any partnership opportunities. At this time, Synergy does not believe that it will obtain any offers that are significantly higher in value than those received to date.
Nevertheless, Synergy remains committed to the continued evaluation of all opportunities to enhance shareholder value, and there is no set timetable for completing this process.
We find this pronouncement rather strange. If indeed the company has received lowball partnership and buyout offers, it seems odd that it would mention this fact in the course of the strategic update focused on the existential threat of penalty payments to CRG. On its face, such an admission would appear to limit Synergy’s options, since it amounts to an announcement that other companies do not want it. But we suspect there is more to it than that.
We do not know what sort of offers, if any, Synergy has received. Perhaps it is being completely honest. But stating that fact puts pressure on CRG. If CRG does not give ground and bankruptcy occurs, it would find it difficult to recoup its losses. Not only would there be significant restructuring, legal, and other costs, but also the risk of losing some of the hard-won formulary access for Trulance.
Such an event would diminish the near-term value of the drug significantly. Thus, we see it as being in CRG’s interest to help Synergy survive rather than threaten its solvency.
It is also important to recognize that its deal with Synergy is the largest reported loan in its portfolio; indeed, it is significantly larger than its median deal size. The high-profile failure of Synergy, apparently driven by CRG’s intransigence, could taint the lender’s brand. CRG bills itself as a “premier healthcare investment partner” and boasts of having “provided a dynamic array of financing solutions for companies across all healthcare sectors.” CRG lends to a range of healthcare companies and it has carved out a strategic niche in the sector. If it does not help Synergy at least weather the current crisis, it could prove problematic for dealmaking down the line.
If Synergy Survives: Amending The Thesis
The current situation is a true crisis. It is also a pure binary event. If Synergy can come to terms with CRG, it will be able to keep the lights on and continue to ramp up Trulance. If such is the case, we would expect an immediate and significant share price jump: doubling at a minimum, perhaps tripling if the new terms are not too punitive or dilutive.
But looking beyond the current crisis scenario, we must also recognize that the thesis must be updated. We cannot model the warrants or new shares CRG might demand, but we can alter our projections based on the newly reported information in Synergy’s October 25th update.
First of all, there is the question of revenues. The update states that it expects full-year revenues to fall between $42 million and $47 million. That comes in below our own modeled expectation of sales. We had forecasted net sales on the order of $50 million for 2018. Uptake is evidently still failing to accelerate, and rising prescription numbers appear now to be the product of price cuts.
Ordinarily, this would strengthen the argument for Synergy to pursue a buyout, given Trulance is projected to reach annual peak sales in excess of $500 million. That would seem to make the pre-news market capitalization of under $500 million seem like a steal. Yet, according to Synergy’s update, offers have not been forthcoming. Whether this is a tactic, as we hypothesized earlier in this research note remains to be seen. But if true, it demands a downward revision of price target.
With $62 million in the bank at the end of Q2 2018, Synergy has enough cash at the then-prevailing burn rate to make it into 2019, provided it does not have to make the punitive repayments to CRG that, at the high end, would amount to perhaps two quarters of operating expenses. Before the latest bombshell, we anticipated that rate to drop, however, thanks to rising revenues from Trulance and continued cost-cutting. We also saw the then still available tranche from the CRG lending facility.
Investor’s Eye View
All things considered, we continue to see value in Synergy, provided it can come to reasonable terms with CRG and move beyond the current existential crisis. It is impossible to call the company a buy at this point, given the risks. However, a successful deal amendment should show immediate and significant positive returns. But this is now a pure speculation play.
We believe the most likely outcome is a deal in which CRG receives better long-term terms as well as warrants or other instruments that would allow it to take effective control of the company at will. CRG has much more to gain from keeping Synergy alive than in letting it die. It could sell off the pieces, but it probably will fail to recoup all of its investment in such circumstances, given the costs, and such actions are not in the lender’s area of expertise.
We would bet on a deal coming through and Synergy living to fight another day. But only investors with iron stomachs and strong appetites for risk would get in on this play now.
Disclosure: I am/we are long SGYP.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Gaps are usually covered. If they can get their financing in order this gap will be filled. If they can't, the gap will not be filled and we will probably go lower or sold for pennies.
I can't see a buyout over $1.00 a share at this point in time, but I could be wrong.
Synergy to Pay Hefty Fines
Synergy Pharmaceuticals Inc (NASDAQ: SGYP) fell in price Friday, after the company reported it will need to pay $38 million-$51 million in penalties if sales of TRULANCE do not meet the minimum amount required per its contract with CRG.
The New York-based Synergy also issued a strategic review update, in which it stated that in April 2015, prior to the FDA approval and launch of TRULANCE® (plecanatide) in 2017, Synergy hired a top-tier advisory firm to engage external parties and evaluate all strategic options available to the Company, including US and ex-U.S. partnerships and a possible sale of the Company.
Ultimately, there were no offers to acquire the Company and no partnership opportunities emerged in this evaluation that it believed aligned with the Company strategically or financially. As a result, Synergy determined the best course of action for the business and Synergy shareholders at that time was to commercialize on its own.
However, the Company has always remained open to, and committed to exploring all strategic and business development opportunities to enhance shareholder value.
These efforts resulted in several recently announced partnerships and collaborations in 2018, including two offshore licensing deals for TRULANCE and a collaboration with the National Cancer Institute for Synergy’s second asset, dolcanatide.
A news release out Thursday said "Synergy does not believe that it will obtain any offers that are significantly higher in value than those received to date. Nevertheless, Synergy remains committed to the continued evaluation of all opportunities to enhance shareholder value, and there is no set timetable for completing this process."
Shares tumbled 97 cents, or 69%, to 43 cents
Synergy Pharmaceuticals Provides Business Update
[Business Wire]
Business WireOctober 25, 2018
NEW YORK--(BUSINESS WIRE)--
Synergy Pharmaceuticals Inc. (SGYP) (the “Company” or “Synergy”), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today provided a business update.
Strategic Review Update
In April 2015, prior to the FDA approval and launch of TRULANCE® (plecanatide) in 2017, Synergy hired a top tier advisory firm to engage external parties and evaluate all strategic options available to the Company, including US and ex-US partnerships and a possible sale of the Company. Ultimately, there were no offers to acquire the Company and no partnership opportunities emerged in this evaluation that it believed aligned with the Company strategically or financially. As a result, Synergy determined the best course of action for the business and Synergy shareholders at that time was to commercialize on its own. However, the Company has always remained open to, and committed to exploring all strategic and business development opportunities to enhance shareholder value. These efforts resulted in several recently announced partnerships and collaborations in 2018, including two ex-US licensing deals for TRULANCE and a collaboration with the National Cancer Institute for Synergy’s second asset, dolcanatide.
In May 2018, Synergy announced that it was running a strategic review process. As part of this extensive review, the Company, assisted by outside strategic and financial advisors, has been exploring multiple options and alternatives to create and enhance shareholder value. The Company held in-depth discussions with numerous potential counterparties regarding various strategic alternatives during this process. To date, the offers received to acquire Synergy have been significantly below the Company’s current market value, and it has been unable to consummate any partnership opportunities. At this time, Synergy does not believe that it will obtain any offers that are significantly higher in value than those received to date. Nevertheless, Synergy remains committed to the continued evaluation of all opportunities to enhance shareholder value, and there is no set timetable for completing this process.
Liquidity Update
In parallel with the strategic review process, Synergy has been seeking to renegotiate the terms of its term loan agreement with CRG Servicing LLC (“CRG”). The Company has been unable to further amend the agreement with respect to the financial and revenue covenants, and the Company has decided to forego drawing down on any additional amounts pursuant to its term loan agreement. Moreover, the Company’s term loan agreement contains a minimum liquidity covenant that absent relief from CRG may not be satisfied. Synergy is continuing discussions with CRG for covenant relief and in parallel the Company is currently pursuing financing alternatives that better align with its business, but there is no assurance that the Company can secure CRG’s consent or otherwise obtain any such financing on commercially reasonable terms, in which case the Company could default under the term loan agreement and may have to pursue or otherwise accelerate strategic alternatives, including the possibility of seeking bankruptcy protection to protect stakeholder value in the event other options are not reasonably executable. Further updates on financing alternatives will be provided when available.
Financial Update
TRULANCE uptake in 2018 has been slower than anticipated due to a highly competitive market access environment and slower than anticipated overall market growth. As a result, based on the Company’s current updated forecasts, Synergy is projecting TRULANCE total net sales for 2018 to be between $42.0 million to $47.0 million, which would be below the minimum revenue covenant of $61.0 million set forth in its term loan agreement with CRG. Under the terms of the agreement, Synergy will be required to repay principal and pay prepayment penalties in an amount equal to $38.0 million to $51.0 million if total net sales fall within the expected range noted above. Such principal repayment and prepayment penalties will be due no later than March 31, 2019. As previously announced, the Company has continued to evaluate opportunities to reduce cash expenditures to better align with anticipated revenues and available capital.
Third Quarter Financial Results
The Company plans to release its third quarter financial results aftermarket on Thursday, November 8, 2018.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate - dolcanatide. For more information, please visit www.synergypharma.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; whether we can obtain financing on commercially reasonable terms; our ability to meet our obligations under the term loan agreement; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Annual Report on Form 10-K for the year ended December 31, 2017 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181025006041/en/
Pareteum Targets Growth in the Americas with New Hires
[PR Newswire]
PR NewswireOctober 19, 2018
David Hess to lead business development in North America
David John to direct growth in Latin America
NEW YORK, Oct. 19, 2018 /PRNewswire/ -- Pareteum Corporation (NYSE American: TEUM), a global cloud software company, has hired business development talent to reach new customers in the Americas: David Hess has been appointed vice president of sales for North America. David John has been named managing director of Latin America.
Pareteum Corporation Logo.
Pareteum Corporation Logo.
As business development strategist for North America, Hess joins Pareteum's executive level management to lead new business initiatives and contribute to the company's global customer base; as managing director in Latin America, John adds to a global sales team at Pareteum that will break new ground for the company in untapped markets.
"David Hess and David John join Pareteum as we are rocketing towards our growth goals as a global technology company," said Executive Chairman and Principal Executive Officer Hal Turner. "Hiring talent to expand our North America presence and connect into Latin America is the obvious step in acquiring new customers and new revenue that will ensure we exceed our targets."
Pareteum Chief Revenue Officer Rob Mumby said, "Hess has an excellent track record of performance in sales and business development, and his talents are already bearing fruit. He has the leadership Pareteum needs to grow in the North America market." Mumby added, "John brings strategic sales experience, political savvy, and a loaded rolodex to the team. Together, these two will bring new opportunities to Pareteum, and thereby the global community of customers we serve."
David Hess has held prominent positions as the former chief executive officer of Telia North America and chief operating officer of KDDI Global, bringing 20 years of success leading operations and sales in the telecommunication, cloud infrastructure, and managed service provider markets. David John has led delivery and operations globally as a strategic partner of AT&T, Vodafone, Telefonica, Telecom Italia, Oi, and Sprint. He has provided solutions to telecom carriers and multinational enterprises in public safety, smart city, and internet of things applications totaling billions in revenue.
About Pareteum Corporation:
Pareteum Corporation (NYSE American: TEUM) is a rapidly growing Global Software Defined Cloud company with a mission to connect "every person and everything." Organizations use Pareteum to energize their growth and profitability through our Global Software Defined Cloud and complete turnkey solutions featuring relevant content, applications, and connectivity worldwide. Our Cloud platform services partners (technologies integrated into our cloud) include: HPE, IBM, Ribbon Communications (Sonus+GenBand), NetNumber, Oracle, Microsoft, and other world class technology providers. All of the relevant customer acquired value is derived from Pareteum's leading Global Software Defined Cloud, delivering award-winning mobile enablement, regardless of the user's location or network. By harnessing the value of communications, Pareteum serves retail, enterprise and IoT customers. Pareteum currently has offices in New York, Sao Paulo, Madrid, Barcelona, Bahrain, Singapore, and the Netherlands. For more information please visit: www.pareteum.com.
NASDAQ:SGYP - Synergy Pharmaceuticals Price Target & Analyst Ratings
$1.47 +0.01 (+0.68 %)
(As of 10/18/2018 04:00 PM ET)
Previous Close
$1.46
Today's Range
$1.45 - $1.56
52-Week Range
$1.28 - $3.19
Volume
1.99 million shs
Average Volume
3.77 million shs
Market Capitalization
$421.58 million
P/E Ratio
-1.44
Dividend Yield
N/A
Beta
1.23
Synergy Pharmaceuticals (NASDAQ:SGYP) Price Target and Consensus Rating (How are Consensus Ratings Calculated?)
7 Wall Street analysts have issued ratings and price targets for Synergy Pharmaceuticals in the last 12 months. Their average twelve-month price target is $9.40, suggesting that the stock has a possible upside of 539.46%. The high price target for SGYP is $13.00 and the low price target for SGYP is $7.00. There are currently 4 hold ratings and 3 buy ratings for the stock, resulting in a consensus rating of "Hold."
Today 30 Days Ago 90 Days Ago 180 Days Ago
Consensus Rating: Hold Hold Buy Buy
Consensus Rating Score: 2.43 2.43 2.50 2.63
Ratings Breakdown: 0 Sell Rating(s)
4 Hold Rating(s)
3 Buy Rating(s)
0 Strong Buy Rating(s) 0 Sell Rating(s)
4 Hold Rating(s)
3 Buy Rating(s)
0 Strong Buy Rating(s) 0 Sell Rating(s)
4 Hold Rating(s)
4 Buy Rating(s)
0 Strong Buy Rating(s) 0 Sell Rating(s)
3 Hold Rating(s)
5 Buy Rating(s)
0 Strong Buy Rating(s)
Consensus Price Target: $9.40 $9.40 $8.8125 $8.8125
Price Target Upside: 539.46% upside 487.50% upside 366.27% upside 361.39% upside
Pareteum to Begin Trading on Nasdaq
[PR Newswire]
PR NewswireOctober 11, 2018
NEW YORK, Oct. 11, 2018 /PRNewswire/ -- Pareteum Corporation (NYSE American: TEUM), a cloud software platform company, today announced that it has been approved for listing on Nasdaq under the symbol "TEUM." Trading on Nasdaq is expected to commence on October 23, 2018. The company's common stock will continue to trade on the NYSE American until the market close on October 22, 2018.
Pareteum Corporation Logo.
Pareteum Corporation Logo.
Pareteum's Principal Executive Officer Hal Turner commented, "Pareteum is pleased to announce our listing on Nasdaq. We believe this move will improve the visibility of our stock, enhance trading liquidity in our shares, and provide us with greater exposure to institutional investors."
About Pareteum:
Pareteum Corporation (NYSE American: TEUM) is a rapidly growing Global Software Defined Cloud company with a mission to connect "every person and everything." Organizations use Pareteum to energize their growth and profitability through our Global Software Defined Cloud and complete turnkey solutions featuring relevant content, applications, and connectivity worldwide. Our Cloud platform services partners (technologies integrated into our cloud) include: HPE, IBM, Ribbon Communications (Sonus+GenBand), NetNumber, Oracle, Microsoft, and other world class technology providers. All of the relevant customer acquired value is derived from Pareteum's leading Global Software Defined Cloud, delivering award-winning mobile enablement, regardless of the user's location or network. By harnessing the value of communications, Pareteum serves retail, enterprise and IoT customers. Pareteum currently has offices in New York, Sao Paulo, Madrid, Barcelona, Bahrain, Singapore and the Netherlands. For more information please visit: www.pareteum.com.
Forward Looking Statements:
Certain statements contained herein constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Pareteum's plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about Pareteum's industry, management's beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Pareteum may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Pareteum also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Pareteum's filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Pareteum Corporation.
Pareteum Expands Customer Base in Asia with 3-year $50 Million Contract
[PR Newswire]
PR NewswireOctober 8, 2018
Thailand's One Development Establishes We Connect
Makes Mobility and Content Service Solutions Widely Available
NEW YORK, Oct. 8, 2018 /PRNewswire/ -- Pareteum Corporation (NYSE American: TEUM), a cloud software platform company, today announced a $50 million contract with One Development, Thailand's first mobile virtual network aggregator and enabler, and leader in the country's growing mobile virtual network operator market. Pareteum's cloud software platform will power One Development's ability to offer a turnkey solution to the over 50 companies that have obtained a mobile virtual network operator license in Thailand.
Pareteum's Global Software Defined Cloud (GSDC) enables One Development's ability to provide flexible solutions for public and private enterprises in Thailand. Pareteum's suite of options make analytics, billing, and branding tools function seamlessly, and makes them available for One Development's customers. Pareteum's SuperAPI serves up developer opportunities to customize content for consumers.
"Consumers in today's digital economy require personalized and innovative services, while public and private enterprises are looking for complete lifecycle support for their digital models. Pareteum's cloud software platform provides us the ability to deliver on these demands and move Thailand forward," said One Development Chief Executive Officer Allan Rasmussen. "With a mobile penetration of 145 percent, the government has introduced Thailand 4.0, and public and private partnerships are subsidizing the Thai market's move from a supply to a demand-driven focus."
Manjot Mann, chief executive officer of Pareteum Asia added, "This contract with One Development moves us quickly and further along our growth path by establishing a market partnership. Pareteum is now on the map in Thailand, a market in Asia yet untapped by our company."
Pareteum Executive Chairman and Principal Executive Officer Hal Turner commented, "One Development's slogan is 'We connect Thailand,' and Pareteum is at the ready to help them do that; when our customers succeed, we succeed. With One Development in Thailand, we are literally connecting to a whole new world of customers and chances to make an impact in the global platform as a service space."
About Pareteum Corporation:
Pareteum Corporation (NYSE American: TEUM) is a rapidly growing Global Software Defined Cloud company with a mission to connect "every person and everything." Organizations use Pareteum to energize their growth and profitability through our Global Software Defined Cloud and complete turnkey solutions featuring relevant content, applications, and connectivity worldwide. Our Cloud platform services partners (technologies integrated into our cloud) include: HPE, IBM, Ribbon Communications (Sonus+GenBand), NetNumber, Oracle, Microsoft, and other world class technology providers. All of the relevant customer acquired value is derived from Pareteum's leading Global Software Defined Cloud, delivering award-winning mobile enablement, regardless of the user's location or network. By harnessing the value of communications, Pareteum serves retail, enterprise and IoT customers. Pareteum currently has offices in New York, São Paulo, Madrid, Barcelona, Bahrain, Singapore, and the Netherlands. For more information please visit: www.pareteum.com.
About One Development:
One Development (Thailand) Company Limited, is the first mobile virtual network aggregator (MVNA), and mobile virtual network enabler (MVNE) in ASEAN. The company provides a flexible turnkey solution of expertise, connectivity, and technology, to launch and operate successful digital services to end-users. Led by highly qualified telco veterans, One Development has the ability to assist public and private enterprises, to build their own mobile virtual network operator (MVNO) service, and help them reach their targets quicker an affordable. The company has its headquarter in Bangkok, Thailand.
For more information please visit: www.weconnectthailand.com
Forward Looking Statements:
Certain statements contained herein constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Pareteum's plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about Pareteum's industry, management's beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Pareteum may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Pareteum also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Pareteum's filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Pareteum Corporation.
Pareteum Investor Relations Contacts:
Ted O'Donnell
Chief Financial Officer
(212) 984-1096
InvestorRelations@pareteum.com
Stephen Hart
Hayden IR
(917) 658-7878
Carrie Howes
Rayleigh Capital
Dubai- London
T UAE: +971 (0) 55 997 0427 | T UK: +44 (0) 870 490 5443 | T CAN: +1 416 900 3634
Synergy Pharmaceuticals Presents New Analyses Supporting the Use of TRULANCE® (plecanatide) in Two Patient Populations at the American College of Gastroenterology (ACG) Annual Scientific Meeting
[Business Wire]
Business WireOctober 8, 2018
NEW YORK--(BUSINESS WIRE)--
New analyses results reinforce effectiveness and safety for the use of TRULANCE in adults with CIC or IBS-C
Synergy Pharmaceuticals Inc. (SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced that the company will present new analyses that further reinforce the efficacy and safety of TRULANCE® (plecanatide) for adult patients with chronic idiopathic constipation (CIC) or irritable bowel syndrome with constipation (IBS-C), specifically in patients aged 65 and older and in patients using concomitant acid suppression medications such as proton pump inhibitors (PPIs) and/or histamine receptor antagonists (H2 blockers). These findings will be presented via two poster presentations this week at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Philadelphia.
Synergy will first present outcomes from a post-hoc analysis of four Phase 3 trials in CIC and IBS-C patients showing the safety and tolerability of TRULANCE in adults ≥65, a group in which constipation is prevalent and there are limited data.
The analysis showed that the safety profile and tolerability of TRULANCE was similar in patients 65 years and older (mean age 72 years) compared to those in the younger cohort less than 65 years (mean age 42 years). TRULANCE also showed similar efficacy between the two age groups (stool consistency, weekly frequency of complete spontaneous bowel movements (CSBMs), and CSBMs within 24 hours of initiating therapy).
Adverse events rates were evaluated between those patients aged 65 years and older (TRULANCE: n=151; placebo n=166) and those younger than 65 years (TRULANCE: n=1,473; placebo n=1,464) to assess the safety risks in the older population. Results show similar adverse events and discontinuation rates for patients aged 65 years and older compared to those younger than 65 years, with the most common adverse event being diarrhea (patients ≥65 years: 4.5% compared to 1.8% for placebo; patients <65 years: 4.4% compared to 1.1% for placebo).
“There is a minimal amount of available data supporting the safety and tolerability of treatments for CIC patients among the 65 and over population,” said Stacy B. Menees, M.D., M.S., University of Michigan, Ann Arbor, MI. “This examination of the data within this patient population reinforces plecanatide as a valuable clinical tool to manage CIC and IBS-C in patients aged 65 years and older.”
Additionally, Synergy will present results from a post-hoc analysis of two 12-week, double-blind, placebo-controlled trials which studied the safety and efficacy of TRULANCE in the treatment of CIC in those patients receiving concomitant acid suppression therapy. Across the two studies, a total of 883 patients received TRULANCE compared to 892 receiving placebo. Of these, approximately 10 percent were also receiving concomitant treatment with acid suppression therapy. The post-hoc analysis explored the impact of these concomitant therapies on efficacy and safety parameters. Efficacy and safety results in this subpopulation of patients were similar to that seen in the overall population.
“Many patients who suffer from constipation are also often on acid suppressing medications. Because TRULANCE is designed to replicate the pH-sensitive activity of human uroguanylin, it was important to understand its efficacy when used along with medications that raise pH level in the gastrointestinal tract,” said Baharak Moshiree, M.D., FACG, Professor of Medicine, University of North Carolina, Atrium Health, Charlotte, NC. “I am pleased these findings further support the efficacy and safety of TRULANCE when used concomitantly with acid suppressing agents.”
“A significant proportion of the CIC and IBS-C patient population have complex medical needs, based on age and comorbidities,” said Patrick H. Griffin, M.D., Chief Medical Officer at Synergy Pharmaceuticals Inc. “We are excited to provide healthcare professionals with new evidence to further reinforce TRULANCE as an efficacious treatment option with a strong safety profile for patients aged 65 years and older, as well as for patients who require concomitant acid suppression therapy.”
TRULANCE is the only prescription medication for adults with CIC and IBS-C that can be taken once-daily, with or without food, at any time of the day.
Indications and Usage
TRULANCE (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
TRULANCE® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of TRULANCE have not been established in pediatric patients less than 18 years of age.
Contraindications
TRULANCE is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
TRULANCE is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
TRULANCE is contraindicated in patients less than 6 years of age. The safety and effectiveness of TRULANCE in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
Use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of TRULANCE should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of TRULANCE-treated CIC patients, and in 1% of TRULANCE-treated IBS-C patients.
If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
In the two combined CIC clinical trials, the most common adverse reaction in TRULANCE-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
In the two combined IBS-C clinical trials, the most common adverse reaction in TRULANCE-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).
About Chronic Idiopathic Constipation (CIC)
CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual’s quality of life, including increasing stress levels and anxiety.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with two or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time. It is estimated that the prevalence of IBS-C in the U.S. adult population is approximately 4 to 5 percent.
About TRULANCE®
TRULANCE® (plecanatide) is a once-daily tablet approved for adults with CIC or IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate - dolcanatide. For more information, please visit www.synergypharma.com.
Forward-Looking Statement
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Annual Report on Form 10-K for the year ended December 31, 2017 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181008005122/en/
Thank you for the post
Can you post the link to that Citi downgrade?
Is the Options Market Predicting a Spike in Synergy Pharmaceuticals (SGYP) Stock?
Zacks Equity Research
ZacksOctober 3, 2018
Is the Options Market Predicting a Spike in Synergy Pharmaceuticals (SGYP) Stock?
Investors need to pay close attention to Synergy Pharmaceuticals (SGYP) stock based on the movements in the options market lately.
Investors in Synergy Pharmaceuticals Inc. SGYP need to pay close attention to the stock based on moves in the options market lately. That is because the Oct 19, 2018 $2.00 Call had some of the highest implied volatility of all equity options today.
What is Implied Volatility?
Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. It could also mean there is an event coming up soon that may cause a big rally or a huge sell off. However, implied volatility is only one piece of the puzzle when putting together an options trading strategy.
What do the Analysts Think?
Clearly, options traders are pricing in a big move for Synergy Pharmaceuticals shares, but what is the fundamental picture for the company?
Currently, Synergy Pharmaceuticals is a Zacks Rank #2 (Buy) in the Medical - Drugs that ranks in the Top 31% of our Zacks Industry Rank. Over the last 60 days, one analyst has increased the earnings estimates for the current quarter, while none have dropped the estimates. The net effect has taken our Zacks Consensus Estimate for the current quarter from a loss of 16 cents per share to a loss of 13 cents in that period.
Given the way analysts feel about Synergy Pharmaceuticals right now, this huge implied volatility could mean there’s a trade developing. Often times, options traders look for options with high levels of implied volatility to sell premium. This is a strategy many seasoned traders use because it captures decay. At expiration, the hope for these traders is that the underlying stock does not move as much as originally expected.
Pareteum Adds $15 Million in New Contracts
PR NewswireOctober 2, 2018
Platform as a Service Unleashes Multiple Use Cases
NEW YORK, Oct. 2, 2018 /PRNewswire/ -- Pareteum Corporation (NYSE American: TEUM), ("Pareteum" or the "Company"), today announced that it has signed new contracts with Parallax Health Sciences in the U.S., oneCentral in the Netherlands, and Naledi in South Africa totaling $15 Million over three years.
New customers will use Pareteum's cloud platform as a service offering to enable voice, mobile, and device and data-monitoring for their companies. These use cases are made possible through the recently-merged Artilium and Pareteum products.
Parallax Health Sciences is Pareteum's first customer in the healthcare IT industry; it will use Pareteum's platform as a service to assist healthcare professionals in diagnosing and tracking health trends with their patients via data and SMS bundling.
The technology integration will result in the establishment of Parallax Communications becoming an industry first: a globally-connected, remote patient care, mobile virtual network operator.
oneCentral is a Netherlands-based provider of telecom and cloud services; Pareteum will enable oneCentral to provide mobility bundles to its customers including voice, SMS, and data.
Additionally, Pareteum will deliver its full platform as a service to Lesotho, South Africa-based Naledi Telecom, enabling it to launch as the first mobile virtual network operator there.
"Pareteum's momentum continues to grow as we close on these multimillion dollar contracts," said Vic Bozzo, chief executive officer of Pareteum. "With these new use cases, we are not only building a pipeline for our growing business, but also enabling mobile solutions for companies across industries, including the ever-important healthcare technology space."
Pareteum Executive Chairman and Principal Executive Officer Hal Turner commented, "We celebrate every new customer that chooses Pareteum's platform to grow their business. With Parallax, oneCentral, and Naledi Telecom, we are adding mobile enablement solutions for companies that serve people across the world, and many of these people are in markets yet touched by the power of Pareteum's seamless and agile platform solution and SuperAPI."
About Pareteum Corporation:
Pareteum Corporation (NYSE American: TEUM) is a rapidly growing Global Software Defined Cloud company with a mission to connect "every person and everything." Organizations use Pareteum to energize their growth and profitability through our Global Software Defined Cloud and complete turnkey solutions featuring relevant content, applications, and connectivity worldwide. Our Cloud platform services partners (technologies integrated into our cloud) include: HPE, IBM, Ribbon Communications (Sonus+GenBand), NetNumber, Oracle, Microsoft, and other world class technology providers. All of the relevant customer acquired value is derived from Pareteum's leading Global Software Defined Cloud, delivering award-winning mobile enablement, regardless of the user's location or network. By harnessing the value of communications, Pareteum serves retail, enterprise and IoT customers. Pareteum currently has offices in New York, Sao Paulo, Madrid, Barcelona, Bahrain, Singapore, and the Netherlands. For more information please visit: www.pareteum.com.
Forward Looking Statements:
Certain statements contained herein constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Pareteum's plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about Pareteum's industry, management's beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Pareteum may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Pareteum also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Pareteum's filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Pareteum Corporation.
Pareteum Investor Relations Contacts:
Ted O'Donnell
Chief Financial Officer
+1 212 984-1096
InvestorRelations@pareteum.com
Stephen Hart
Hayden IR
+1 917 658-7878
Carrie Howes
Rayleigh Capital
Dubai- London
T UAE: +971 (0) 55 997 0427 | T UK: +44 (0) 870 490 5443 | T CAN: +1 416 900 3634
Synergy Pharmaceuticals to Present New Analyses of TRULANCE® (Plecanatide) at the American College of Gastroenterology (ACG) Annual Scientific Meeting
[Business Wire]
Business WireOctober 1, 2018
NEW YORK--(BUSINESS WIRE)--
New analyses further reinforce effectiveness and safety in important subpopulations of adults with CIC or IBS-C
Synergy Pharmaceuticals Inc. (SGYP), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today announced that two posters will be presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, October 5-10, 2018, in Philadelphia, PA.
Presentations include a poster detailing outcomes from a large post-hoc analysis evaluating the safety and tolerability of TRULANCE® (plecanatide) in chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) in patients aged 65 and older compared to those in a younger cohort (≥18 to <65).
Synergy will also present data from a post-hoc analysis which evaluated the efficacy and safety of TRULANCE therapy when given in combination with acid suppression medications.
The findings will be presented via poster presentations as follows:
Evaluation of the Safety and Tolerability of Plecanatide in CIC and IBS-C Patients Aged 65 and Older (P0335), to be presented on Sunday, October 7, 2018 from 5:15 p.m. – 6:30 p.m. ET, by Stacy B. Menees, M.D., M.S., University of Michigan, Ann Arbor, MI
Acid Suppression Therapy Does Not Affect the Efficacy of Plecanatide: A Patient-Level Pooled Analysis of Two Large Randomized Controlled Trials (P1222), to be presented on Monday, October 8, 2018, 1:00 p.m. – 2:15 p.m. ET, by Baharak Moshiree, M.D., FACG, Professor of Medicine, University of North Carolina, Atrium Health, Charlotte, NC
Indications and Usage
TRULANCE (plecanatide) 3 mg tablets is indicated in adults for the treatment of Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome with Constipation (IBS-C).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
TRULANCE® is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice administration of a single oral dose of plecanatide caused deaths due to dehydration. Use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. The safety and efficacy of TRULANCE have not been established in pediatric patients less than 18 years of age.
Contraindications
TRULANCE is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
TRULANCE is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
TRULANCE is contraindicated in patients less than 6 years of age. The safety and effectiveness of TRULANCE in patients less than 18 years of age have not been established. In young juvenile mice (human age equivalent of approximately 1 month to less than 2 years), plecanatide increased fluid secretion as a consequence of stimulation of guanylate cyclase-C (GC-C), resulting in mortality in some mice within the first 24 hours, apparently due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than older patients to develop severe diarrhea and its potentially serious consequences.
Use of TRULANCE should be avoided in patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young mice and the lack of clinical safety and efficacy data in pediatric patients, use of TRULANCE should be avoided in patients 6 years to less than 18 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in the four placebo-controlled clinical trials for CIC and IBS-C. Severe diarrhea was reported in 0.6% of TRULANCE-treated CIC patients, and in 1% of TRULANCE-treated IBS-C patients.
If severe diarrhea occurs, the health care provider should suspend dosing and rehydrate the patient.
Adverse Reactions
In the two combined CIC clinical trials, the most common adverse reaction in TRULANCE-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (5% vs 1% placebo).
In the two combined IBS-C clinical trials, the most common adverse reaction in TRULANCE-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (4.3% vs 1% placebo).
About Chronic Idiopathic Constipation (CIC)
CIC affects approximately 14 percent of the global population, disproportionately affecting women and older adults. People with CIC have persistent symptoms of difficult-to-pass and infrequent bowel movements. In addition to physical symptoms including abdominal bloating and discomfort, CIC can adversely affect an individual’s quality of life, including increasing stress levels and anxiety.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with two or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time. It is estimated that the prevalence of IBS-C in the U.S. adult population is approximately 4 to 5 percent.
About TRULANCE®
TRULANCE® (plecanatide) is a once-daily tablet approved for adults with CIC or IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.
About Synergy Pharmaceuticals
Synergy is a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies. The company has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary GI platform includes one commercial product TRULANCE® (plecanatide) and a second product candidate - dolcanatide. For more information, please visit www.synergypharma.com.
Forward-Looking Statement
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. These forward-looking statements are based on Synergy's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy's Annual Report on Form 10-K for the year ended December 31, 2017 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181001005059/en/
Pareteum Breaks into Platform as a Service Market
PR NewswireSeptember 26, 2018
Mobile Enablement Portal Simplifies Customer Experience
NEW YORK, Sept. 26, 2018 /PRNewswire/ -- Pareteum Corporation (NYSE American: TEUM) today released availability of its self-service portal for communications service providers and developers to connect with and build programs for the internet of things..
Pareteum's SuperAPI and integrated portal make geographic boundaries disappear for global communications service providers, so they can connect internet of things devices and services across continents. The portal also gives developers connectivity in more than 75 countries, and a self-service SuperAPI so they can build unique internet of things solutions for their customers.
With Pareteum's portal, communications service providers can securely manage massive volumes of data, as well as charging and billing, with real-time access and monitoring for every connected device that drives their business; developers around the world can open a treasure trove of communications features and add them into their own applications without needing to build backend.
"Pareteum brings a seamless, simple solution to the platform services market. We expect this to be a $4 billion market within a couple of years," said Ali Davachi, Chief Operating Officer and Chief Technology Officer of Pareteum. "With the rise in number of internet of things connected devices and the subsequent explosion in total volume of data, businesses have a growing need for software that can manage and analyze information efficiently."
Pareteum's Executive Chairman and Principal Executive Officer Hal Turner commented, "Pareteum intends to be at the forefront of the platform services market. Our global connectivity network and mobile enablement solutions help us achieve our mission by providing a singular solution that helps our customers around the world scale their businesses and build stellar communications tools for the internet of things."
About Pareteum Corporation:
Pareteum Corporation (NYSE American: TEUM) is a rapidly growing Global Software Defined Cloud company with a mission to connect "every person and everything." Organizations use Pareteum to energize their growth and profitability through our Global Software Defined Cloud and complete turnkey solutions featuring relevant content, applications, and connectivity worldwide. Our Cloud platform services partners (technologies integrated into our cloud) include: HPE, IBM, Ribbon Communications (Sonus+GenBand), NetNumber, Oracle, Microsoft, and other world class technology providers. All of the relevant customer acquired value is derived from Pareteum's leading Global Software Defined Cloud, delivering award-winning mobile enablement, regardless of the user's location or network. By harnessing the value of communications, Pareteum serves retail, enterprise and IoT customers. Pareteum currently has offices in New York, Sao Paulo, Madrid, Barcelona, Bahrain, Singapore, and the Netherlands. For more information please visit: www.pareteum.com.
Forward Looking Statements:
Certain statements contained herein constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Pareteum's plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current expectations, estimates and projections about Pareteum's industry, management's beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Pareteum may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Pareteum also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Pareteum's filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Pareteum Corporation.
Pareteum Investor Relations Contacts:
Ted O'Donnell
Chief Financial Officer
(212) 984-1096
InvestorRelations@pareteum.com
Hayden IR
(917) 658-7878
Carrie Howes
Rayleigh Capital
Dubai- London
T UAE: +971 (0) 55 997 0427 | T UK: +44 (0) 870 490 5443 | T CAN: +1 416 900 3634
Funny thing is I have two feeds going at one time and they were both stopped. See it trading now. Thanks