[May 10, 2017] |
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Synergy Pharmaceuticals Reports First Quarter 2017 Financial Results and Business Update
Synergy (News - Alert) Pharmaceuticals Inc. (NASDAQ:SGYP), a biopharmaceutical company
focused on the development and commercialization of novel
gastrointestinal (GI) therapies, today reported its financial results
and business update for the three months ended March 31, 2017.
"The first three months of this year have been among the most
significant in the company's history and are highlighted by several
important milestones that demonstrate our continued commitment to
scientifically driven innovation and providing novel treatment options
for patients and healthcare providers," said Gary S. Jacob, PhD,
Chairman and Chief Executive Officer of Synergy Pharmaceuticals Inc.
"Following the early FDA approval of TRULANCE for the treatment of
adults with CIC in January, our commercial team initiated TRULANCE
promotion on March 20th and we are very pleased with the
encouraging feedback from patients and key prescribers, as well as the
early uptake of TRULANCE after only a few weeks of marketing. In
addition, we have made tremendous progress moving conversations forward
with payers and will continue all efforts to increase access for
patients. While it is still early in the launch, everything we are
seeing reinforces the significant opportunity for TRULANCE to treat
adults with CIC over the coming years. Looking ahead, we will continue
to focus on the TRULANCE launch in CIC, while working with the FDA to
broaden the product label with the IBS-C indication. We look forward to
updating you on our progress in the coming months."
Gary Gemignani, Synergy's newly appointed EVP and Chief Financial
Officer added, "I am honored to have joined Synergy at this pivotal
juncture where I see significant opportunity to capitalize on the strong
foundation we have in place to drive further growth. Synergy controls
100% of the worldwide rights to TRULANCE, a high value asset that is now
generating revenues and has secured a long lifespan that we will be able
to maximize. We remain focused on having a disciplined approach to
capital allocation to support appropriate investments that will ensure
the long-term success of TRULANCE. I look forward to working with Gary
and the team as we continue to pursue growth, strengthen our balance
sheet and drive shareholder value."
First Quarter 2017 and Recent Highlights
TRULANCE™ (plecanatide) CIC Update
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In January 2017, the United States Food and Drug Administration (FDA)
approved TRULANCE for the treatment of adults with CIC. In clinical
trials, TRULANCE helped 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 was
preferred by the majority of patients versus a traditional pill bottle.
TRULANCE IBS-C Development Update
-
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.
TRULANCE IP Update
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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.
TRULANCE Commercial Launch Update
Driving Awareness of TRULANCE and Stimulating Trial and Adoption
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Our sales force of approximately 250 is fully deployed across the U.S.
and now educating approximately 27,000 high prescribers about TRULANCE.
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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.
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To date, our sales force has reached over 80% of the prescribers
in the top three deciles.
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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.
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Since launch, approximately 50% of TRULANCE prescriptions are
coming from other branded prescription products and 50% are
new patients.
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Over 300,000 7-day sample packs of TRULANCE have been distributed to
the field force, to-date.
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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.
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Launched a comprehensive print and digital media plan to drive
awareness of TRULANCE and stimulate trial and adoption among target
prescribers.
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Presented new TRULANCE data and insights from the BURDEN-CIC study at
DDW 2017.
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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.
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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.
Ensuring Market Access
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To-date, approximately 60% of adult CIC patients with commercial
insurance have unrestricted access to TRULANCE.
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The TRULANCE "Savings-to-Go" program helps to ensure an average copay
of $25 per prescription for over 95% of patients with commercial
insurance.
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The TRULANCE Access Support Services Program provides healthcare
providers and patients additional assistance for certain managed care
plans that require prior authorizations.
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Medicare Part D and Medicaid discussions are ongoing and progressing
well.
Activating and Supporting the Rx Ready Patient
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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.
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TRULANCE Branded Campaign:
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Point-of-care promotion: targeting ~20,000 offices.
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Web sponsorships and display advertisements generated over 36
million impressions, to-date.
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Search engine marketing initiatives generated over 65,000
clicks, to-date.
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Over 100,000 visits to the Trulance.com consumer site, to-date.
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"Confront Constipation" Campaign:
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Disease awareness initiative designed to increase the
understanding and improve the dialogue between patients,
prescribers, and other health care providers on managing CIC.
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Campaign has generated 28 original media placements and over
300 million media impressions, to-date.
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Over 60,000 downloads of the Poop Troop emoji keyboard,
to-date.
Financial Results
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As of March 31, 2017, we had approximately $139.3 million of cash and
cash equivalents on hand as compared to approximately $82.4 million of
cash and cash equivalents as of December 31, 2016.
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Net cash used in operating activities was $63.5 million in the three
months ended March 31, 2017, as compared to $27.6 million in the three
months ended March 31, 2016. This increase is primarily attributable
to the buildout of the commercial organization and costs related to
the launch of TRULANCE, including the building of inventory.
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We had net deferred revenues of $4.3 million during the three months
ended March 31, 2017 as we first began distributing our product in
March of 2017. We expect that these revenues will be recognized in
future periods.
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Net sales in the first quarter of 2017 were approximately $0.1 million
as we first began distributing our product in late March of 2017.
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Cost of goods sold in the first quarter of 2017 was approximately $1.8
million.
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Research and development expenses in the first quarter of 2017 were
approximately $19.1 million, as compared to $21.2 million in the first
quarter of 2016. This decrease in research and development expenses
was due primarily to lower spending on CIC clinical studies.
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Selling, general and administrative expenses were approximately $41.9
million in the first quarter of 2017, as compared to approximately
$6.4 million in the first quarter of 2016. This increase is primarily
attributable to the buildout of the commercial organization and costs
related to the launch of TRULANCE.
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On February 6, 2017, we closed on a registered direct offering of
approximately 20.3 million shares of our common stock with net
proceeds of approximately $121.6 million.
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As of March 31, 2017, the principal balance on our Notes was $18.6
million as compared to $23.5 million at December 31, 2016.
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We had 224.9 million and 202.7 million common shares issued and
outstanding at March 31, 2017 and December 31, 2016, respectively,
which reflects primarily an increase in the issuance of shares from
the common stock offering noted above and the first quarter
conversions of the Notes.
-
Net loss in the first quarter of 2017 was $64.6 million, as compared
to a net loss of $59.9 million incurred in the first quarter of 2016.
About Synergy Pharmaceuticals Inc.
Synergy is a biopharmaceutical company focused on the development and
commercialization of novel GI therapies. The company has pioneered
discovery, research and development efforts on analogs of uroguanylin, a
naturally occurring and endogenous human GI peptide, for the treatment
of GI diseases and disorders. Synergy's proprietary GI platform includes
one commercial product TRULANCE and a second lead product candidate,
dolcanatide. For more information, please visit www.synergypharma.com.
About TRULANCE™
TRULANCE™ (plecanatide) is a once-daily tablet approved for
adults with CIC and is being evaluated for 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.
TRULANCE Important Safety Information
Indications and Usage
TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for
the treatment of chronic idiopathic constipation (CIC).
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
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Trulance is contraindicated in patients less than 6 years of age due
to the risk of serious dehydration.
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Trulance is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Risk of Serious Dehydration in Pediatric Patients
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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.
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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 two
placebo-controlled clinical trials. Severe diarrhea was reported in
0.6% of patients.
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If severe diarrhea occurs, the health care provider should suspend
dosing and rehydrate the patient.
Adverse Reactions
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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).
Please click here for
Full Prescribing Information.
Forward-Looking Statement
This press release and any statements made for and during any
presentation or meeting contain forward-looking statements related to
Synergy Pharmaceuticals Inc. under the safe harbor provisions of Section
21E of the Private Securities Litigation Reform Act of 1995 and are
subject to risks and uncertainties that could cause actual results to
differ materially from those projected. These statements may be
identified by the use of forward-looking words such as "anticipate,"
"planned," "believe," "forecast," "estimated," "expected," and "intend,"
among others. 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, the
development, launch, introduction and commercial potential of TRULANCE;
growth and opportunity, including peak sales and the potential demand
for TRULANCE, as well as its potential impact on applicable markets;
market size; 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; dependence upon third parties; our financial
performance and results, including the risk that we are unable to manage
our operating expenses or cash use for operations, or are unable to
commercialize our products, within the guided ranges or otherwise as
expected; 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 most recent periodic reports filed with the
Securities and Exchange Commission, including Synergy's Form 10-K for
the year ended December 31, 2016. 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 except as required by law.
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Synergy Pharmaceutical Inc.
Condensed Consolidated Balance Sheets
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($ in thousands)
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March 31, 2017 (unaudited)
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December 31, 2016
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Assets
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Cash and cash equivalents
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$
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139,262
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$
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82,387
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Accounts receivable
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6,319
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-
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Inventories
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9,647
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5,640
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Prepaid expenses and other current assets
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8,038
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889
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Total Current assets
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163,266
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88,916
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Other assets
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976
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936
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Total assets
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$
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164,242
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$
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89,852
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Liabilities and Stockholders' Equity
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Total Current Liabilities
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$
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43,489
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$
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29,430
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Senior Convertible Notes, net
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16,771
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22,665
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Derivative financial instruments - warrants
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94
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216
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Total Liabilities
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60,354
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52,311
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Total Stockholders' Equity
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103,888
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37,541
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Total Liabilities and Stockholders' Equity
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$
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164,242
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$
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89,852
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Condensed Consolidated Statement of Operations
($ in thousands except share and per share data)
(unaudited)
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Three Months Ended March 31,
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Three Months Ended March 31,
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2017
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2016
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Net sales
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$
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98
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$
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-
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Cost of goods sold
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1,805
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-
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Gross profit
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(1,707
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)
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-
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Costs and Expenses:
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Research and development
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19,129
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21,175
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Selling, general and administrative
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41,891
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6,375
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Loss from Operations
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(62,727
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)
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(27,550
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)
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Other Expenses:
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Interest and investment expense, net
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(790
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(7,036
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Debt conversion expense
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(1,209
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)
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(25,615
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)
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Change in fair value of derivative financial instruments - warrants
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122
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260
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Total Other Expenses
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(1,877
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)
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(32,391
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Net Loss
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$
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(64,604
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)
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$
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(59,941
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)
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Net Loss per Common Share, Basic and Diluted
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$
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(0.30
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)
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$
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(0.51
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)
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Weighted Average Common Shares Outstanding
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215,484,670
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117,626,669
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View source version on businesswire.com: http://www.businesswire.com/news/home/20170510006636/en/
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