Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2017

News Archive

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Third Quarter Ended June 30, 2017

 

Enanta Announces U.S. FDA Approval of AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in as Little as 8 Weeks

 

Enanta Announces U.S. FDA Approval of AbbVie’s MAVYRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) in as Little as 8 Weeks

 

Enanta Announces European Commission Grants AbbVie Marketing Authorization for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

 

Enanta Pharmaceuticals to Host Conference Call on August 7 at 4:30 p.m. ET to Discuss Financial Results for its Fiscal Third Quarter Ended June 30, 2017

 

Enanta Announces New Data on EDP-938, a Novel Non-Fusion Inhibitor of Respiratory Syncytial Virus (RSV), at the XIX International Symposium on Respiratory Viral Infections

 

Enanta Announces that AbbVie Receives CHMP Positive Opinion for MAVIRET™ (glecaprevir/pibrentasvir) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)

 

CORRECTING and REPLACING Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

WATERTOWN, Mass.–(BUSINESS WIRE)–May 8, 2017–
Seventh paragraph, second sentence of release dated May 8, 2017, should
read: “For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 per diluted common share…” (instead of $1.28
million per diluted common share).

The corrected release reads:

ENANTA PHARMACEUTICALS REPORTS FINANCIAL RESULTS FOR ITS FISCAL
SECOND QUARTER ENDED MARCH 31, 2017

Webcast and Conference Call today at 4:30 p.m. ET

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today reported
financial results for its fiscal second quarter ended March 31, 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $240.9 million at March 31, 2017. This compares to a
total of $242.2 million in such accounts at September 30, 2016. Enanta
expects that its current cash, cash equivalents and marketable
securities will be sufficient to meet the anticipated cash requirements
of its existing business and development programs for the foreseeable
future.

Fiscal Second Quarter Ended March 31, 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March 31,
2016. For the six months ended March 31, 2017, total revenue was $19.4
million, compared to $61.4 million for the same period in 2016. For the
three and six month periods ended March 31 2017, revenue consisted
exclusively of royalties earned on AbbVie’s worldwide net sales of HCV
regimens containing paritaprevir. For the 2016 six month period, revenue
consisted primarily of royalty revenues as well as a $30.0 million
milestone payment for the reimbursement approval of VIEKIRAX® in Japan.
Milestone payments and royalties have varied significantly from period
to period, and we expect that variability to continue in the future.

Research and development expenses totaled $13.0 million for the three
months ended March 31, 2017, compared to $9.1 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
research and development expenses totaled $25.5 million compared to
$18.2 million for the same period in 2016. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s wholly-owned
R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

General and administrative expenses totaled $5.5 million for the three
months ended March 31, 2017, compared to $4.4 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
general and administrative expenses was $10.4 million, compared to $8.2
million for the same period in 2016. For the three month period, the
increase in general and administrative expenses was primarily due to
increases in stock-based compensation expense driven by increased
headcount. For the six month period, the increase was due to increased
headcount as well as achievement of milestones under existing
performance-based stock awards.

Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of $1.6
million for the same period in 2016. The Company’s estimated annual
effective tax rate for fiscal 2017 of 33.0 percent was slightly below
the statutory rate of 35.0 percent due to the availability of federal
research and development tax credits.

Net loss for the three months ended March 31, 2017 was $5.4 million, or
$(0.28) per diluted common share, compared to net loss of $1.6 million,
or ($0.09) per diluted common share, for the corresponding period in
2016. For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 per diluted common share, for the corresponding
period in 2016.

“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “Any
such payments, coupled with our existing financial resources, will allow
us to advance our clinical program in NASH/PBC and also fund our
additional R&D programs, including our lead compound EDP-938 for RSV,
scheduled to begin clinical development later this year.”

Development Program and Business Review

Upcoming Events and Presentations

On June 25 at the XIX International Symposium on Respiratory Viral
Infections in Berlin, Germany, Enanta will present data on EDP-938, its
respiratory syncytial virus inhibitor candidate in an oral presentation
titled: “EDP-938, a Novel Non-Fusion Replication Inhibitor of
Respiratory Syncytial Virus, Demonstrates Potent Antiviral Activities
both In Vitro and In Vivo”.

Conference Call and Webcast Information
Enanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. To
participate in the live conference call, please dial (855) 840-0595 in
the U.S. or (518) 444-4814 for international callers. A replay of the
conference call will be available starting at approximately 7:30 p.m.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for
international callers. The passcode for both the live call and the
replay is 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan and other jurisdictions. Royalties and any further milestone
payments from this collaboration will provide additional funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s investigational G/P regimen in HCV and the
prospects for advancement of Enanta’s earlier stage programs in NASH/PBC
and RSV. Statements that are not historical facts are based on
management’s current expectations, estimates, forecasts and projections
about Enanta’s business and the industry in which it operates and
management’s beliefs and assumptions. The statements contained in this
release are not guarantees of future performance and involve certain
risks, uncertainties and assumptions, which are difficult to predict.
Therefore, actual outcomes and results may differ materially from what
is expressed in such forward-looking statements. Important factors and
risks that may affect actual results include: Enanta’s revenues in the
short-term are dependent upon the success of AbbVie’s continuing
commercialization efforts for its HCV treatment regimens containing
paritaprevir; Enanta’s longer-term revenues will be dependent upon the
success of AbbVie’s efforts to obtain regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV products
on the market and product candidates of other companies under
development; the discovery and development risks of early stage
discovery efforts in other disease areas such as NASH, PBC,RSV and HBV;
potential competition from the development efforts of others in those
other disease areas; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key scientific
personnel; Enanta’s need to obtain and maintain patent protection for
its product candidates and avoid potential infringement of the
intellectual property rights of others; and other risk factors described
or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for
the fiscal year ended September 30, 2016 and other periodic reports
filed more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These statements speak only as of
the date of this release, and Enanta undertakes no obligation to update
or revise these statements, except as may be required by law.

1 Presumed NAFLD subjects in this study are obese subjects,
with or without pre-diabetes or type-2 diabetes.

     

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except per share amounts)
                 
Three Months Ended Six Months Ended
March 31, March 31,
2017 2016 2017 2016
 
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449
Operating expenses
Research and Development 13,004 9,143 25,530 18,176
General and administrative   5,461     4,426     10,398     8,244  
Total operating expenses   18,465     13,569     35,928     26,420  
Income (loss) from operations (9,506 ) (565 ) (16,552 ) 35,029
Other income, net   549     472     1,073     801  
Income (loss) before income taxes (8,957 ) (93 ) (15,479 ) 35,830
Income tax (expense) benefit   3,565     (1,552 )   5,107     (11,286 )
Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372 ) $ 24,544  
 
Net income (loss) per share
Basic $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.30
Diluted $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.28
 
Weighted average common shares outstanding
Basic 19,047 18,921 19,042 18,848
Diluted 19,047 18,921 19,042 19,225
 
           

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 
March 31, September 30,
2017 2016
Assets
Current assets
Cash and cash equivalents $ 19,211 $ 16,577
Short-term marketable securities 156,362 193,507
Accounts receivable 8,959 12,841
Prepaid expenses and other current assets   6,059   9,231
Total current assets 190,591 232,156
Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119
Deferred tax assets 13,903 8,390
Restricted cash   608   608
Total assets $ 278,958 $ 281,277
 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 4,056 $ 3,377
Accrued expenses and other current liabilities   5,098   4,512
Total current liabilities 9,154 7,889
Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159
Other long-term liabilities   2,355   2,042
Total liabilities   12,947   11,341
Total stockholders’ equity   266,011   269,936
Total liabilities and stockholders’ equity $ 278,958 $ 281,277
 

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

Webcast and Conference Call today at 4:30 p.m. ET

WATERTOWN, Mass.–(BUSINESS WIRE)–May 8, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today reported
financial results for its fiscal second quarter ended March 31, 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $240.9 million at March 31, 2017. This compares to a
total of $242.2 million in such accounts at September 30, 2016. Enanta
expects that its current cash, cash equivalents and marketable
securities will be sufficient to meet the anticipated cash requirements
of its existing business and development programs for the foreseeable
future.

Fiscal Second Quarter Ended March 31, 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March 31,
2016. For the six months ended March 31, 2017, total revenue was $19.4
million, compared to $61.4 million for the same period in 2016. For the
three and six month periods ended March 31 2017, revenue consisted
exclusively of royalties earned on AbbVie’s worldwide net sales of HCV
regimens containing paritaprevir. For the 2016 six month period, revenue
consisted primarily of royalty revenues as well as a $30.0 million
milestone payment for the reimbursement approval of VIEKIRAX® in Japan.
Milestone payments and royalties have varied significantly from period
to period, and we expect that variability to continue in the future.

Research and development expenses totaled $13.0 million for the three
months ended March 31, 2017, compared to $9.1 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
research and development expenses totaled $25.5 million compared to
$18.2 million for the same period in 2016. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s wholly-owned
R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

General and administrative expenses totaled $5.5 million for the three
months ended March 31, 2017, compared to $4.4 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
general and administrative expenses was $10.4 million, compared to $8.2
million for the same period in 2016. For the three month period, the
increase in general and administrative expenses was primarily due to
increases in stock-based compensation expense driven by increased
headcount. For the six month period, the increase was due to increased
headcount as well as achievement of milestones under existing
performance-based stock awards.

Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of $1.6
million for the same period in 2016. The Company’s estimated annual
effective tax rate for fiscal 2017 of 33.0 percent was slightly below
the statutory rate of 35.0 percent due to the availability of federal
research and development tax credits.

Net loss for the three months ended March 31, 2017 was $5.4 million, or
$(0.28) per diluted common share, compared to net loss of $1.6 million,
or ($0.09) per diluted common share, for the corresponding period in
2016. For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 million per diluted common share, for the
corresponding period in 2016.

“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “Any
such payments, coupled with our existing financial resources, will allow
us to advance our clinical program in NASH/PBC and also fund our
additional R&D programs, including our lead compound EDP-938 for RSV,
scheduled to begin clinical development later this year.”

Development Program and Business Review

Upcoming Events and Presentations

Conference Call and Webcast Information
Enanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. To
participate in the live conference call, please dial (855) 840-0595 in
the U.S. or (518) 444-4814 for international callers. A replay of the
conference call will be available starting at approximately 7:30 p.m.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for
international callers. The passcode for both the live call and the
replay is 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan and other jurisdictions. Royalties and any further milestone
payments from this collaboration will provide additional funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s investigational G/P regimen in HCV and the
prospects for advancement of Enanta’s earlier stage programs in NASH/PBC
and RSV. Statements that are not historical facts are based on
management’s current expectations, estimates, forecasts and projections
about Enanta’s business and the industry in which it operates and
management’s beliefs and assumptions. The statements contained in this
release are not guarantees of future performance and involve certain
risks, uncertainties and assumptions, which are difficult to predict.
Therefore, actual outcomes and results may differ materially from what
is expressed in such forward-looking statements. Important factors and
risks that may affect actual results include: Enanta’s revenues in the
short-term are dependent upon the success of AbbVie’s continuing
commercialization efforts for its HCV treatment regimens containing
paritaprevir; Enanta’s longer-term revenues will be dependent upon the
success of AbbVie’s efforts to obtain regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV products
on the market and product candidates of other companies under
development; the discovery and development risks of early stage
discovery efforts in other disease areas such as NASH, PBC,RSV and HBV;
potential competition from the development efforts of others in those
other disease areas; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key scientific
personnel; Enanta’s need to obtain and maintain patent protection for
its product candidates and avoid potential infringement of the
intellectual property rights of others; and other risk factors described
or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for
the fiscal year ended September 30, 2016 and other periodic reports
filed more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These statements speak only as of
the date of this release, and Enanta undertakes no obligation to update
or revise these statements, except as may be required by law.

1 Presumed NAFLD subjects in this study are obese subjects,
with or without pre-diabetes or type-2 diabetes.

     

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except per share amounts)
                 
Three Months Ended Six Months Ended
March 31, March 31,
2017 2016 2017 2016
 
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449
Operating expenses
Research and Development 13,004 9,143 25,530 18,176
General and administrative   5,461     4,426     10,398     8,244  
Total operating expenses   18,465     13,569     35,928     26,420  
Income (loss) from operations (9,506 ) (565 ) (16,552 ) 35,029
Other income, net   549     472     1,073     801  
Income (loss) before income taxes (8,957 ) (93 ) (15,479 ) 35,830
Income tax (expense) benefit   3,565     (1,552 )   5,107     (11,286 )
Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372 ) $ 24,544  
 
Net income (loss) per share
Basic $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.30
Diluted $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.28
 
Weighted average common shares outstanding
Basic 19,047 18,921 19,042 18,848
Diluted 19,047 18,921 19,042 19,225
 
           

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 
March 31, September 30,
2017 2016
Assets
Current assets
Cash and cash equivalents $ 19,211 $ 16,577
Short-term marketable securities 156,362 193,507
Accounts receivable 8,959 12,841
Prepaid expenses and other current assets   6,059   9,231
Total current assets 190,591 232,156
Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119
Deferred tax assets 13,903 8,390
Restricted cash   608   608
Total assets $ 278,958 $ 281,277
 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 4,056 $ 3,377
Accrued expenses and other current liabilities   5,098   4,512
Total current liabilities 9,154 7,889
Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159
Other long-term liabilities   2,355   2,042
Total liabilities   12,947   11,341
Total stockholders’ equity   266,011   269,936
Total liabilities and stockholders’ equity $ 278,958 $ 281,277
 

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com

 

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Second Quarter Ended March 31, 2017

Webcast and Conference Call today at 4:30 p.m. ET

WATERTOWN, Mass.–(BUSINESS WIRE)–May 8, 2017–
Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a research and
development-focused biotechnology company dedicated to creating small
molecule drugs for viral infections and liver diseases, today reported
financial results for its fiscal second quarter ended March 31, 2017.

Enanta’s cash, cash equivalents and short-term and long-term marketable
securities totaled $240.9 million at March 31, 2017. This compares to a
total of $242.2 million in such accounts at September 30, 2016. Enanta
expects that its current cash, cash equivalents and marketable
securities will be sufficient to meet the anticipated cash requirements
of its existing business and development programs for the foreseeable
future.

Fiscal Second Quarter Ended March 31, 2017 Financial Results

Total revenue for the three months ended March 31, 2017 was $9.0
million, compared to $13.0 million for the three months ended March 31,
2016. For the six months ended March 31, 2017, total revenue was $19.4
million, compared to $61.4 million for the same period in 2016. For the
three and six month periods ended March 31 2017, revenue consisted
exclusively of royalties earned on AbbVie’s worldwide net sales of HCV
regimens containing paritaprevir. For the 2016 six month period, revenue
consisted primarily of royalty revenues as well as a $30.0 million
milestone payment for the reimbursement approval of VIEKIRAX® in Japan.
Milestone payments and royalties have varied significantly from period
to period, and we expect that variability to continue in the future.

Research and development expenses totaled $13.0 million for the three
months ended March 31, 2017, compared to $9.1 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
research and development expenses totaled $25.5 million compared to
$18.2 million for the same period in 2016. The increase in research and
development expenses was primarily due to increased preclinical and
clinical costs associated with the progression of Enanta’s wholly-owned
R&D programs in non-alcoholic steatohepatitis (NASH)/primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

General and administrative expenses totaled $5.5 million for the three
months ended March 31, 2017, compared to $4.4 million for the three
months ended March 31, 2016. For the six months ended March 31, 2017,
general and administrative expenses was $10.4 million, compared to $8.2
million for the same period in 2016. For the three month period, the
increase in general and administrative expenses was primarily due to
increases in stock-based compensation expense driven by increased
headcount. For the six month period, the increase was due to increased
headcount as well as achievement of milestones under existing
performance-based stock awards.

Enanta recorded an income tax benefit for the three months ended March
31, 2017 of $3.6 million compared to an income tax expense of $1.6
million for the same period in 2016. The Company’s estimated annual
effective tax rate for fiscal 2017 of 33.0 percent was slightly below
the statutory rate of 35.0 percent due to the availability of federal
research and development tax credits.

Net loss for the three months ended March 31, 2017 was $5.4 million, or
$(0.28) per diluted common share, compared to net loss of $1.6 million,
or ($0.09) per diluted common share, for the corresponding period in
2016. For the six months ended March 31, 2017, net loss was $10.4
million, or ($0.54) per diluted common share, compared to net income of
$24.5 million, or $1.28 million per diluted common share, for the
corresponding period in 2016.

“With our second partnered protease inhibitor product, glecaprevir,
expected to launch starting in August as part of AbbVie’s new,
investigational G/P treatment for HCV, the prospects for additional
milestone and royalty payments to us for G/P are significant,” stated
Jay R. Luly, Ph.D., President and Chief Executive Officer, Enanta. “Any
such payments, coupled with our existing financial resources, will allow
us to advance our clinical program in NASH/PBC and also fund our
additional R&D programs, including our lead compound EDP-938 for RSV,
scheduled to begin clinical development later this year.”

Development Program and Business Review

Upcoming Events and Presentations

Conference Call and Webcast Information
Enanta will host a
conference call and webcast today at 4:30 p.m. Eastern time. To
participate in the live conference call, please dial (855) 840-0595 in
the U.S. or (518) 444-4814 for international callers. A replay of the
conference call will be available starting at approximately 7:30 p.m.
Eastern time on May 8, 2017, through 11:59 p.m. Eastern time on May 12,
2017 by dialing (855) 859-2056 from the U.S. or (404) 537-3406 for
international callers. The passcode for both the live call and the
replay is 6851190. A live audio webcast of the call and replay can be
accessed by visiting the “Calendar of Events” section on the “Investors”
page of Enanta’s website at www.enanta.com.

About Enanta
Enanta Pharmaceuticals is a research and
development-focused biotechnology company that uses its robust
chemistry-driven approach and drug discovery capabilities to create
small molecule drugs for viral infections and liver diseases. Enanta’s
research and development efforts are currently focused on the following
disease targets: non-alcoholic steatohepatitis (NASH)/ primary biliary
cholangitis (PBC), respiratory syncytial virus (RSV) and hepatitis B
virus (HBV).

Enanta has discovered novel protease inhibitors for use against the
hepatitis C virus (HCV). These protease inhibitors, developed through
Enanta’s collaboration with AbbVie, include paritaprevir, currently
marketed in AbbVie’s HCV regimens, and glecaprevir (ABT-493), Enanta’s
second protease inhibitor product, which AbbVie is developing as part of
its investigational, pan-genotypic HCV regimen of
glecaprevir/pibrentasvir (G/P) now in registration in the U.S., the E.U.
and Japan and other jurisdictions. Royalties and any further milestone
payments from this collaboration will provide additional funding for
Enanta’s earlier development programs, including its Phase 1 FXR agonist
program for NASH/PBC, and its preclinical programs for HBV and RSV.
Please visit www.enanta.com
for more information on Enanta’s programs and pipeline.

Forward Looking Statements
This press release contains
forward-looking statements, including statements with respect to the
prospects for AbbVie’s investigational G/P regimen in HCV and the
prospects for advancement of Enanta’s earlier stage programs in NASH/PBC
and RSV. Statements that are not historical facts are based on
management’s current expectations, estimates, forecasts and projections
about Enanta’s business and the industry in which it operates and
management’s beliefs and assumptions. The statements contained in this
release are not guarantees of future performance and involve certain
risks, uncertainties and assumptions, which are difficult to predict.
Therefore, actual outcomes and results may differ materially from what
is expressed in such forward-looking statements. Important factors and
risks that may affect actual results include: Enanta’s revenues in the
short-term are dependent upon the success of AbbVie’s continuing
commercialization efforts for its HCV treatment regimens containing
paritaprevir; Enanta’s longer-term revenues will be dependent upon the
success of AbbVie’s efforts to obtain regulatory approvals for G/P and
commercialize that regimen; competitive pricing, market acceptance and
reimbursement rates of AbbVie’s treatment regimens containing
paritaprevir or its G/P combination compared to competitive HCV products
on the market and product candidates of other companies under
development; the discovery and development risks of early stage
discovery efforts in other disease areas such as NASH, PBC,RSV and HBV;
potential competition from the development efforts of others in those
other disease areas; Enanta’s lack of clinical development experience;
Enanta’s need to attract and retain senior management and key scientific
personnel; Enanta’s need to obtain and maintain patent protection for
its product candidates and avoid potential infringement of the
intellectual property rights of others; and other risk factors described
or referred to in “Risk Factors” in Enanta’s most recent Form 10-K for
the fiscal year ended September 30, 2016 and other periodic reports
filed more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the forward-looking
statements contained in this release. These statements speak only as of
the date of this release, and Enanta undertakes no obligation to update
or revise these statements, except as may be required by law.

1 Presumed NAFLD subjects in this study are obese subjects,
with or without pre-diabetes or type-2 diabetes.

     

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
UNAUDITED
(in thousands, except per share amounts)
                 
Three Months Ended Six Months Ended
March 31, March 31,
2017 2016 2017 2016
 
Revenue $ 8,959 $ 13,004 $ 19,376 $ 61,449
Operating expenses
Research and Development 13,004 9,143 25,530 18,176
General and administrative   5,461     4,426     10,398     8,244  
Total operating expenses   18,465     13,569     35,928     26,420  
Income (loss) from operations (9,506 ) (565 ) (16,552 ) 35,029
Other income, net   549     472     1,073     801  
Income (loss) before income taxes (8,957 ) (93 ) (15,479 ) 35,830
Income tax (expense) benefit   3,565     (1,552 )   5,107     (11,286 )
Net income (loss) $ (5,392 ) $ (1,645 ) $ (10,372 ) $ 24,544  
 
Net income (loss) per share
Basic $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.30
Diluted $ (0.28 ) $ (0.09 ) $ (0.54 ) $ 1.28
 
Weighted average common shares outstanding
Basic 19,047 18,921 19,042 18,848
Diluted 19,047 18,921 19,042 19,225
 
           

ENANTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
UNAUDITED
(in thousands)
 
March 31, September 30,
2017 2016
Assets
Current assets
Cash and cash equivalents $ 19,211 $ 16,577
Short-term marketable securities 156,362 193,507
Accounts receivable 8,959 12,841
Prepaid expenses and other current assets   6,059   9,231
Total current assets 190,591 232,156
Property and equipment, net 8,526 8,004
Long-term marketable securities 65,330 32,119
Deferred tax assets 13,903 8,390
Restricted cash   608   608
Total assets $ 278,958 $ 281,277
 
Liabilities and Stockholders’ Equity
Current liabilities
Accounts payable $ 4,056 $ 3,377
Accrued expenses and other current liabilities   5,098   4,512
Total current liabilities 9,154 7,889
Warrant liability 1,276 1,251
Series 1 nonconvertible preferred stock 162 159
Other long-term liabilities   2,355   2,042
Total liabilities   12,947   11,341
Total stockholders’ equity   266,011   269,936
Total liabilities and stockholders’ equity $ 278,958 $ 281,277
 

Source: Enanta Pharmaceuticals, Inc.

Investor Contact
Enanta Pharmaceuticals, Inc.
Carol
Miceli, 617-607-0710
cmiceli@enanta.com
or
Media
Contact

MacDougall Biomedical Communications
Kari Watson,
781-235-3060
kwatson@macbiocom.com