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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Synergy Pharmaceuticals, Inc. | NASDAQ:SGYP | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.03 | 0.0488 | 0.049 | 0 | 01:00:00 |
|
Delaware
|
|
33-0505269
|
(State or Other Jurisdiction of Incorporation or Organization)
|
|
(I.R.S. Employer Identification No.)
|
Large accelerated filer
x
|
|
Accelerated filer
o
|
|
|
|
Non-accelerated filer
o
|
|
Smaller reporting company
o
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(Do not check if a smaller reporting company)
|
|
|
|
|
|
Page
|
|
||
|
||
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||
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||
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||
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|
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Three Months Ended March 31,
|
||||||
|
2017
|
|
2016
|
||||
Net sales
|
$
|
98
|
|
|
$
|
—
|
|
Cost of goods sold
|
1,805
|
|
|
—
|
|
||
Gross profit
|
(1,707
|
)
|
|
—
|
|
||
|
|
|
|
||||
Costs and expenses:
|
|
|
|
||||
Research and development
|
19,129
|
|
|
21,175
|
|
||
Selling, general and administrative
|
41,891
|
|
|
6,375
|
|
||
Loss from operations
|
(62,727
|
)
|
|
(27,550
|
)
|
||
Other expenses
|
|
|
|
||||
Interest and investment expense, net
|
(790
|
)
|
|
(7,036
|
)
|
||
Debt conversion expense
|
(1,209
|
)
|
|
(25,615
|
)
|
||
Change in fair value of derivative instruments-warrants
|
122
|
|
|
260
|
|
||
Total other expenses
|
(1,877
|
)
|
|
(32,391
|
)
|
||
Net loss
|
$
|
(64,604
|
)
|
|
$
|
(59,941
|
)
|
|
|
|
|
||||
Weighted Average Common Shares Outstanding
|
|
|
|
||||
Basic and Diluted
|
215,484,670
|
|
|
117,626,669
|
|
||
|
|
|
|
||||
Net Loss per Common Share, Basic and Diluted
|
|
|
|
||||
Net Loss per Common Share, Basic and Diluted
|
$
|
(0.30
|
)
|
|
$
|
(0.51
|
)
|
|
Common
Shares
|
|
Common
Stock,
Par Value
|
|
Additional
Paid in
Capital
|
|
Deficit
Accumulated
|
|
Total
Stockholders’ Equity |
|||||||||
Balance, December 31, 2016
|
202,737,860
|
|
|
$
|
20
|
|
|
$
|
620,513
|
|
|
$
|
(582,992
|
)
|
|
$
|
37,541
|
|
Notes conversions
|
1,579,099
|
|
|
1
|
|
|
4,911
|
|
|
—
|
|
|
4,912
|
|
||||
Debt conversion expense
|
212,800
|
|
|
—
|
|
|
1,209
|
|
|
—
|
|
|
1,209
|
|
||||
Common stock issued in connection with exercise of stock options
|
89,978
|
|
|
—
|
|
|
329
|
|
|
—
|
|
|
329
|
|
||||
Common stock issued in registered direct offering
|
20,325,204
|
|
|
2
|
|
|
121,949
|
|
|
—
|
|
|
121,951
|
|
||||
Fees related to registered direct offering
|
—
|
|
|
—
|
|
|
(347
|
)
|
|
—
|
|
|
(347
|
)
|
||||
Stock based compensation expense
|
—
|
|
|
—
|
|
|
2,897
|
|
|
—
|
|
|
2,897
|
|
||||
Net loss for the period
|
—
|
|
|
—
|
|
|
—
|
|
|
(64,604
|
)
|
|
(64,604
|
)
|
||||
Balance, March 31, 2017
|
224,944,941
|
|
|
$
|
23
|
|
|
$
|
751,461
|
|
|
$
|
(647,596
|
)
|
|
$
|
103,888
|
|
|
Three Months Ended
March 31, 2017 |
|
Three Months Ended
March 31, 2016 |
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Net loss
|
$
|
(64,604
|
)
|
|
$
|
(59,941
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
41
|
|
|
38
|
|
||
Amortization of deferred debt costs
|
608
|
|
|
4,153
|
|
||
Stock-based compensation expense
|
2,897
|
|
|
1,202
|
|
||
Change in fair value of derivative instruments—warrants
|
(122
|
)
|
|
(260
|
)
|
||
Common stock issued for interest on Notes
|
—
|
|
|
2,445
|
|
||
Debt conversion expense
|
1,209
|
|
|
25,615
|
|
||
Transaction fees on Note conversions
|
—
|
|
|
(435
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(6,319
|
)
|
|
—
|
|
||
Inventories
|
(4,007
|
)
|
|
—
|
|
||
Security deposit
|
(65
|
)
|
|
—
|
|
||
Prepaid expenses and other current assets
|
(7,149
|
)
|
|
(56
|
)
|
||
Accounts payable and accrued expenses
|
9,512
|
|
|
(800
|
)
|
||
Deferred revenues, net
|
4,260
|
|
|
—
|
|
||
Accrued interest expense on senior convertible notes
|
287
|
|
|
487
|
|
||
Total Adjustments
|
1,152
|
|
|
32,389
|
|
||
Net Cash used in Operating Activities
|
(63,452
|
)
|
|
(27,552
|
)
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Net sales of available-for-sale securities
|
—
|
|
|
50,097
|
|
||
Additions to property and equipment
|
(15
|
)
|
|
(43
|
)
|
||
Net Cash used in (provided by) Investing Activities
|
(15
|
)
|
|
50,054
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Proceeds of sale of common stock
|
121,951
|
|
|
—
|
|
||
Payment for deferred financing costs
|
(1,591
|
)
|
|
—
|
|
||
Fees and expenses — sale of common stock
|
(347
|
)
|
|
—
|
|
||
Proceeds from exercise of stock options
|
329
|
|
|
—
|
|
||
Net Cash provided by Financing Activities
|
120,342
|
|
|
—
|
|
||
Net increase in cash and cash equivalents
|
56,875
|
|
|
22,502
|
|
||
Cash and cash equivalents at beginning of period
|
82,387
|
|
|
61,653
|
|
||
Cash and cash equivalents at end of period
|
$
|
139,262
|
|
|
$
|
84,155
|
|
Supplementary disclosure of cash flow information:
|
|
|
|
||||
Cash paid for taxes
|
$
|
44
|
|
|
$
|
45
|
|
Supplementary disclosure of non-cash investing and financing activities:
|
|
|
|
||||
Conversion of senior convertible notes to Synergy Common Stock
|
$
|
4,912
|
|
|
$
|
82,274
|
|
|
Notes Balance
|
|
Deferred Debt Costs
|
|
Notes, net of
Deferred Debt Costs |
||||||
Balance December 31, 2015
|
159,011
|
|
|
7,770
|
|
|
151,241
|
|
|||
Less: amortization three months ended March 31, 2016
(1)
|
|
|
(4,153
|
)
|
|
4,153
|
|
||||
Conversions
|
(79,829
|
)
|
|
—
|
|
|
(79,829
|
)
|
|||
Balance, March 31, 2016
|
79,182
|
|
|
3,617
|
|
|
75,565
|
|
|||
Less: amortization three months ended June 30, 2016
|
|
|
(253
|
)
|
|
253
|
|
||||
Balance, June 30, 2016
|
79,182
|
|
|
3,364
|
|
|
75,818
|
|
|||
Less: amortization three months ended September 30, 2016
|
|
|
(252
|
)
|
|
252
|
|
||||
Balance, September 30, 2016
|
79,182
|
|
|
3,112
|
|
|
76,070
|
|
|||
Less: amortization three months ended December 31, 2016
(1)
|
|
|
(2,263
|
)
|
|
2,263
|
|
||||
Conversions
|
(55,668
|
)
|
|
—
|
|
|
(55,668
|
)
|
|||
Balance, December 31, 2016
|
23,514
|
|
|
849
|
|
|
22,665
|
|
|||
Deferred financing cost related to debt modification on February 28, 2017
|
|
|
1,591
|
|
|
(1,591
|
)
|
||||
Less: amortization three months ended March 31, 2017
(1)
|
|
|
(608
|
)
|
|
608
|
|
||||
Conversions
|
(4,911
|
)
|
|
—
|
|
|
(4,911
|
)
|
|||
Balance, March 31, 2017
|
$
|
18,603
|
|
|
$
|
1,832
|
|
|
$
|
16,771
|
|
|
Three Months Ended
March 31, |
|
Three Months Ended
March 31, |
||||
($ in thousands)
|
2017
|
|
2016
|
||||
Included in research and development
|
$
|
1,873
|
|
|
$
|
810
|
|
Included in general and administrative
|
1,024
|
|
|
392
|
|
||
Total stock-based compensation expense
|
$
|
2,897
|
|
|
$
|
1,202
|
|
|
Three Months Ended
March 31, 2017 |
|
Three Months Ended
March 31, 2016 |
||
Risk-free interest rate
|
1.96%-2.26%
|
|
|
1.47%-1.74%
|
|
Dividend yield
|
—
|
|
|
—
|
|
Expected volatility
|
50
|
%
|
|
60
|
%
|
Expected term (in years)
|
6 years
|
|
|
6 years
|
|
|
Number of
Options
|
|
Exercise Price
Per Share
|
|
Weighted Average
Exercise Price
Per Share
|
|
Intrinsic
Value
(in thousands)
|
|
Weighted Average
Remaining
Contractual Term
|
|||||
Balance outstanding, December 31, 2016
(1)
|
27,867,171
|
|
|
$0.44-9.12
|
|
$
|
3.78
|
|
|
$
|
65,618
|
|
|
7.1 years
|
Granted
|
843,500
|
|
|
$4.57-6.77
|
|
6.06
|
|
|
—
|
|
|
|
||
Exercised
(2)
|
(89,978
|
)
|
|
$1.90-5.34
|
|
1.90
|
|
|
203,957
|
|
|
|
||
Forfeited
|
(836,145
|
)
|
|
$2.83-7.91
|
|
4.50
|
|
|
—
|
|
|
|
||
Balance outstanding, March 31, 2017
(1)
|
27,784,548
|
|
|
$0.44-9.12
|
|
$
|
3.91
|
|
|
$
|
31,558
|
|
|
6.9 years
|
|
|
|
|
|
|
|
|
|
|
|||||
Exercisable, at March 31, 2017
|
13,913,788
|
|
|
$0.44-9.12
|
|
$
|
3.70
|
|
|
$
|
17,227
|
|
|
5.7 years
|
(2)
|
The Company received proceeds of approximately
$0.3 million
from the exercise of stock options during the
three months ended March 31, 2017
.
|
|
Three Months Ended
March 31, 2017 |
|
Three Months Ended
March 31, 2016 |
||||
Fair value of Synergy common stock
|
$
|
4.66
|
|
|
$
|
2.76
|
|
Expected warrant term
|
0.9 years
|
|
|
1.9 years
|
|
||
Risk-free interest rate
|
0.68
|
%
|
|
0.80
|
%
|
||
Expected volatility
|
50
|
%
|
|
60
|
%
|
||
Dividend yield
|
—
|
|
|
—
|
|
Date
|
|
Description
|
|
Warrants
|
|
Derivative
Instrument
Liability
(in thousands)
|
|||
12/31/2016
|
|
Balance of derivative financial instruments liability
|
|
210,000
|
|
|
$
|
216
|
|
3/31/2017
|
|
Change in fair value of warrants during the three months ended March 31, 2017
|
|
|
|
(122
|
)
|
||
3/31/2017
|
|
Balance of derivative financial instruments liability
|
|
210,000
|
|
|
$
|
94
|
|
Description
|
|
Quoted Prices
in
Active
Markets
for Identical
Assets and
Liabilities
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Balance as of
December 31, 2016 |
|
Quoted Prices
in
Active
Markets
for Identical
Assets and
Liabilities
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Balance as of
March 31, 2017 |
||||||||||||||||
Derivative liabilities related to Warrants
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
216
|
|
|
$
|
216
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
94
|
|
|
$
|
94
|
|
Description
|
|
Balance as of
December 31, 2016 |
|
(Gain) or loss
recognized in
earning from
Change in Fair
Value
|
|
Expiration of
warrants
|
|
Balance as of
March 31, 2017 |
||||||||
Derivative liabilities related to Warrants
|
|
$
|
216
|
|
|
$
|
(122
|
)
|
|
$
|
—
|
|
|
$
|
94
|
|
|
Three Months Ended
March 31, 2017 |
|
Three Months Ended
March 31, 2016 |
||
Stock Options
|
27,784,548
|
|
|
21,227,948
|
|
Warrants
|
919,690
|
|
|
4,726,823
|
|
Senior Convertible Notes
|
5,981,672
|
|
|
25,460,450
|
|
Total shares issuable upon exercise or conversion
|
34,685,910
|
|
|
51,415,221
|
|
•
|
In January 2017, the United States Food and Drug Administration (FDA) approved TRULANCE for the treatment of adults with CIC. TRULANCE can help improve stool consistency and provide more regular bowel movements. TRULANCE is the only prescription medication for CIC that can be taken once-daily, with or without food, at any time of the day. In addition, TRULANCE is the only prescription medication for CIC available in a unique calendar pack that is patient preferred versus a traditional pill bottle.
|
•
|
In March 2017, we submitted a sNDA for TRULANCE for the treatment of adults with IBS-C. We expect a 10-month review period from the submission date of March 24, 2017. The application is based on data from two of the largest Phase 3 IBS-C clinical trials to date, which evaluated more than 2,100 patients. In both 12-week studies, TRULANCE met the primary endpoint and showed statistical significance in the percentage of patients who were Overall Responders compared to placebo. The FDA has defined an Overall Responder as a patient who achieves ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movement (CSBM) from baseline, in the same week, for at least 50% of the 12 treatment weeks.
|
•
|
On April 12, 2017, we announced that the United States Patent and Trademark Office (USPTO) has issued three new patents covering TRULANCE. The first patent relates to the method for manufacturing TRULANCE and will expire March 1, 2032. The two other patents relate to formulations and methods of using TRULANCE for treating chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) at 3mg or 6 mg dose; both of these patents will expire September 15, 2031.
|
•
|
Our sales force of approximately 250 is fully deployed across the U.S. and now educating approximately 27,000 high prescribers about TRULANCE.
|
•
|
The targeted prescriber base includes gastroenterologists, primary care physicians, nurse practitioners and physician assistants that currently account for approximately 70% of the total branded prescriptions, according to QuintilesIMS.
|
•
|
To date, our sales force has reached over 80% of the prescribers in the top three deciles.
|
•
|
According to QuintilesIMS analog research, we are exceeding expectations in terms of penetration and adoption curves with top decile prescribers after one month of launch.
|
•
|
Since launch, approximately 50% of TRULANCE prescriptions are coming from other branded prescription products and 50% are new patients.
|
•
|
Over 300,000 7-day sample packs of TRULANCE have been distributed to the field force, to-date.
|
•
|
Initiated peer-to-peer educational programs with approximately 140 gastroenterologists now educating local gastroenterologists, primary care physicians and other health care professionals on patient, disease and product-specific information to enable appropriate use of TRULANCE.
|
•
|
Launched a comprehensive print and digital media plan to drive awareness of TRULANCE and stimulate trial and adoption among target prescribers.
|
•
|
Presented new TRULANCE data and insights from the BURDEN-CIC study at DDW 2017.
|
•
|
Presented six abstracts, including one late-breaker oral presentation highlighting TRULANCE data from the two Phase 3 IBS-C trials. Two of the abstracts were recognized by the American Gastroenterology Association (AGA) as Posters of Distinction.
|
•
|
Presented new insights from the BURDEN-CIC study that examined patient and physician perceptions and experiences with CIC. The results highlight the condition’s impact and show the need for additional CIC treatment options.
|
•
|
To-date, approximately 60% of adult CIC patients with commercial insurance have unrestricted access to TRULANCE.
|
•
|
The TRULANCE “Savings-to-Go” program helps to ensure an average copay of $25 per prescription for over 95% of patients with commercial insurance.
|
•
|
The TRULANCE Access Support Services Program provides healthcare providers and patients additional assistance for certain managed care plans that require prior authorizations.
|
•
|
Medicare Part D and Medicaid discussions are ongoing and progressing well.
|
•
|
Launched consumer media campaigns to support the product launch and drive awareness of the TRULANCE brand and the current unmet needs of patients with CIC.
|
•
|
TRULANCE Branded Campaign:
|
•
|
Point-of-care promotion: targeting ~20,000 offices.
|
•
|
Web sponsorships and display advertisements generated over 36 million impressions, to-date.
|
•
|
Search engine marketing initiatives generated over 65,000 clicks, to-date.
|
•
|
Over 100,000 visits to the Trulance.com consumer site, to-date.
|
•
|
“Confront Constipation” Campaign:
|
•
|
Disease awareness initiative designed to increase the understanding and improve the dialogue between patients, prescribers, and other health care providers on managing CIC.
|
•
|
Campaign has generated 28 original media placements and over 300 million media impressions, to-date.
|
•
|
Over 60,000 downloads of the Poop Troop emoji keyboard, to-date.
|
|
SYNERGY PHARMACEUTICALS INC.
|
|
|
(Registrant)
|
|
|
|
|
Date: May 10, 2017
|
By:
|
/s/ GARY S. JACOB
|
|
|
Gary S. Jacob
|
|
|
President, Chairman of Board, and Chief Executive Officer
|
|
|
|
Date: May 10, 2017
|
By:
|
/s/ GARY G. GEMIGNANI
|
|
|
Gary G. Gemignani
|
|
|
Executive Vice President, Chief Financial Officer
|
Date: May 10, 2017
|
/s/ GARY S. JACOB
|
|
Gary S. Jacob
|
|
President, Chairman of Board, and Chief Executive Officer
|
Date: May 10, 2017
|
/s/ GARY G. GEMIGNANI
|
|
Gary G. Gemignani
|
|
Executive Vice President, Chief Financial Officer
|
Date: May 10, 2017
|
/s/ GARY S. JACOB
|
|
Gary S. Jacob
|
|
President, Chairman of Board, and Chief Executive Officer
|
Date: May 10, 2017
|
/s/ GARY G. GEMIGNANI
|
|
Gary G. Gemignani
|
|
Executive Vice President, Chief Financial Officer
|
1 Year Synergy Pharmaceuticals, Inc. Chart |
1 Month Synergy Pharmaceuticals, Inc. Chart |
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