Agios Pharmaceuticals Reports Third Quarter 2013 Financial Results

  Agios Pharmaceuticals Reports Third Quarter 2013 Financial Results

   Successfully Completed Initial Public Offering and Advanced IDH2 Cancer
                 Metabolism Program into Clinical Development

Business Wire

CAMBRIDGE, Mass. -- November 7, 2013

Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the fields of cancer
metabolism and inborn errors of metabolism, today reported business highlights
and financial results for the third quarter ended September 30, 2013.

“Agios has made important progress this year toward realizing our long-term
vision of developing transformational medicines and building a world-class
biopharmaceutical company,” said David Schenkein, M.D., chief executive
officer at Agios. “We successfully completed our initial public offering,
ending the period with $208.4 million in cash, cash equivalents and marketable
securities. We initiated a Phase 1 clinical trial of our lead product
candidate, AG-221, in a genetically defined population of patients carrying an
IDH2 mutation. In addition to AG-221, we are continuing to make progress on
our goal of advancing a broad portfolio of first-in-class cancer metabolism
and inborn errors of metabolism drug candidates toward the clinic, including
AG-120, an IDH1 inhibitor for the treatment of cancer in patients with an IDH1
mutation, and AG-348, an activator of pyruvate kinase for the treatment of
patients with pyruvate kinase deficiency, and we remain on track with our
plans to begin clinical testing of both of these drug candidates in 2014.”

Recent Business Highlights

  *Completed initial public offering. Agios announced on July 29, 2013 that
    it had completed an initial public offering (IPO) of common stock, raising
    net proceeds of $111.0 million. In addition, Celgene purchased $12.8
    million of Agios common stock in a separate private placement concurrent
    with the completion of the IPO.
  *Initiated Phase 1 study of AG-221, an IDH2 mutant inhibitor for the
    treatment of cancer in patients with an IDH2 mutation. In September, Agios
    announced that the first patient was dosed in a Phase 1 study of AG-221 in
    advanced hematologic malignancies with an IDH2 mutation. This Phase 1,
    multi-center study is evaluating the safety, pharmacokinetics,
    pharmacodynamics and clinical activity of AG-221 in patients with advanced
    hematologic malignancies that harbor an IDH2 mutation. The first stage of
    the study is a dose-escalation phase in which cohorts of patients will
    receive ascending oral doses of AG-221 to determine the maximum tolerated
    dose and/or the recommended Phase 2 dose. At completion of the dose
    escalation phase, several expansion cohorts of patients will receive
    AG-221 to further evaluate the safety, tolerability and clinical activity
    of the maximum tolerated dose. Currently, four clinical trial sites are
    open and recruiting patients. AG-221 is an orally available, selective,
    potent inhibitor of the mutated IDH2 protein, making it a highly targeted
    therapeutic candidate for the treatment of patients with cancers with an
    IDH2 mutation.
  *Advanced AG-120, an IDH1 mutant inhibitor for the treatment of cancer in
    patients with an IDH1 mutation, toward Investigational New Drug (IND)
    filing. Agios has substantially completed IND-enabling studies of AG-120
    and remains on track for initiating clinical trials in early 2014. AG-120
    is an orally available, selective, potent inhibitor of the mutated IDH1
    protein, and a highly targeted therapeutic candidate for the treatment of
    patients with cancers that harbor an IDH1 mutation. Phase 1 trials are
    being planned for patients with advanced solid and hematological
    malignancies that carry an IDH1 mutation.
  *Advanced AG-348, an activator of pyruvate kinase R (PKR) for the treatment
    of patients with pyruvate kinase deficiency (PK deficiency), into
    IND-enabling studies. Agios has initiated IND-enabling preclinical studies
    of AG-348, an orally available, potent small molecule activator of the PKR
    enzyme, which, when mutated, leads to PK deficiency, a form of hereditary
    hemolytic anemia. Pre-clinical in vitro data demonstrate that these
    activators can significantly enhance the activity of most of the common
    PKR mutations, making it a potential treatment for patients with PK
    deficiency.
  *Strengthened board of directors. In September, Agios announced the
    addition of Paul J. Clancy, executive vice president and chief financial
    officer at Biogen Idec, to its board of directors.

Upcoming Milestones

  *Agios expects to present preclinical data for each of its lead programs at
    the annual American Society for Hematology (ASH) meeting in December 2013.
  *In early 2014, Agios anticipates submitting an IND and initiating Phase 1
    clinical trials for AG-120 in patients with advanced solid and
    hematological malignancies that carry an IDH1 mutation.
  *Agios anticipates submitting an IND and initiating Phase 1 clinical trials
    for AG-348 in 2014, including normal healthy volunteers and patients with
    PK deficiency.

Third Quarter 2013 Financial Results & Financial Guidance

  *Cash Position: Cash, cash equivalents and marketable securities as of
    September 30, 2013 were $208.4 million, compared to $128.0 million as of
    December 31, 2012. The increase was primarily driven by net proceeds of
    $111.0 million from Agios’ IPO and $12.8 million from the concurrent
    private placement with Celgene, offset by cash used to fund operations.
  *Revenues: Collaboration revenue was $6.3 million in each of the third
    quarters of 2013 and 2012 and $18.8 million in each of the nine months
    ended September 30, 2013 and 2012. Collaboration revenue is primarily
    comprised of deferred revenue from payments received in previous periods
    from Agios’ collaboration agreement with Celgene.
  *R&D Expenses: Research and development expenses were $14.8 million in the
    third quarter of 2013 and $39.2 million in the nine months ended September
    30, 2013, compared to $9.8 million and $29.8 million in the comparable
    periods in 2012. The increase in R&D expense was largely due to increased
    spending on clinical activities as AG-221 entered Phase 1 development in
    September 2013, in addition to IND-enabling activities for the company’s
    AG-120 and AG-348 programs.
  *G&A Expenses: General and administrative expenses were $2.5 million in the
    third quarter of 2013 and $6.2 million in the nine months ended September
    30, 2013, compared to $1.6 million and $5.5 million in the comparable
    periods in 2012. The increase in G&A expenses was largely due to
    incremental expenses to support public company operations.
  *Net Loss: Net loss was $11.2 million for the third quarter of 2013 and
    $27.0 million for the nine months ended September 30, 2013, compared to
    net loss of $4.6 million and $14.8 million for the comparable periods in
    2012.
  *Financial Guidance: Agios expects that its cash, cash equivalents and
    marketable securities will be sufficient to fund its operating expenses
    and capital expenditure requirements until at least the fourth quarter of
    2016.

Conference Call Information

Agios will host a conference call and live audio webcast today at 8:30 a.m.
EST to discuss the quarter and recent business activities. To participate in
the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547
(international) and refer to conference ID 92532816. The live webcast can be
accessed under “Events & Presentations” in the Investors and Media section of
the company’s website at www.agios.com. The archived webcast will be available
on the company’s website beginning approximately two hours after the event.

About Agios Pharmaceuticals, Inc.

Agios Pharmaceuticals is focused on discovering and developing novel drugs to
treat cancer and inborn errors of metabolism, or IEMs, which are rare genetic
metabolic diseases, through scientific leadership in the field of cellular
metabolism. In addition to an active research and discovery pipeline across
both therapeutic areas, Agios has multiple first-in-class lead product
candidates in cancer metabolism and IEMs in clinical and/or preclinical
development. All Agios programs focus on genetically identified patient
populations leveraging our knowledge of metabolism, biology and genomics. For
more information, please visit our website at www.agios.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of
The Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include those regarding Agios’ expectations and beliefs about: the
potential of IDH1/IDH2 and pyruvate kinase R mutations as therapeutic targets;
the potential benefits of Agios’ product candidates targeting IDH1/IDH2 or
pyruvate kinase R mutations, including AG-221, AG-120 and AG-348; its plans
and timelines for the clinical development of AG-221, AG-120 and AG-348; its
plans regarding future data presentations; its financial guidance regarding
the period in which cash will be available to fund its operating expenses and
capital expenditure requirements; and the benefit of its strategic plans and
focus. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,”
“may,” “plan,” “predict,” “project,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such statements
are subject to numerous important factors, risks and uncertainties that may
cause actual events or results to differ materially from Agios’ current
expectations and beliefs. For example, there can be no guarantee that any
product candidate Agios is developing will successfully commence or complete
necessary preclinical and clinical development phases, or that development of
any of Agios’ product candidates will successfully continue. There can be no
guarantee that any positive developments in Agios’ business will result in
stock price appreciation. Management’s expectations and, therefore, any
forward-looking statements in this press release could also be affected by
risks and uncertainties relating to a number of other important factors,
including: Agios’ results of clinical trials and preclinical studies,
including subsequent analysis of existing data and new data received from
ongoing and future studies; the content and timing of decisions made by the
U.S. FDA and other regulatory authorities, investigational review boards at
clinical trial sites and publication review bodies; Agios’ ability to obtain
and maintain requisite regulatory approvals and to enroll patients in its
planned clinical trials; unplanned cash requirements and expenditures;
competitive factors; Agios’ ability to obtain, maintain and enforce patent and
other intellectual property protection for any product candidates it is
developing; and general economic and market conditions. These and other risks
are described in greater detail under the caption “Risk Factors” included in
Agios’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, and
other filings that Agios may make with the Securities and Exchange Commission
(SEC) in the future. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Agios expressly disclaims any
obligation to update any forward-looking statements, whether as a result of
new information, future events or otherwise.






AGIOS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)
(Amounts in thousands)
                                                             
                                                September 30,     December 31,
                                                2013              2012
Cash, cash equivalents, and marketable          $   208,368       $  127,976
securities
Total assets                                        219,069          137,008
Deferred revenue                                    63,907           82,711
Preferred stock                                     -                115,922
Stockholders' equity (deficit)                      142,595          (72,024 )






AGIOS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(Amounts in thousands except per share data)

                     Three Months Ended               Nine Months Ended
                                                
                     September 30,                    September 30,
                     2013           2012            2013           2012
                                                                       
Total revenue        $ 6,268          $ 6,268         $ 18,804         $ 18,824
                                                                       
Operating
expenses:
  Research and         14,803           9,798           39,223           29,812
  development
  General and         2,534          1,580         6,222          5,510    
  administrative
Total operating        17,337           11,378          45,445           35,322
expenses
                                                                       
Loss from              (11,069  )       (5,110  )       (26,641  )       (16,498  )
operations
                                                                       
Interest income        13               13              26               61
                                                                       
Provision
(benefit) for          121              (452    )       410              (1,648   )
income taxes
                                                                    
Net loss              ($11,177 )      ($4,645 )      ($27,025 )      ($14,789 )
Cumulative
preferred stock       567            1,798         4,162          5,393    
dividends
Net loss
applicable to         ($10,610 )      ($2,847 )      ($22,863 )      ($9,396  )
common
stockholders
                                                                       
Net loss per
share applicable
to common
stockholders:
  Basic and            ($0.47   )       ($0.83  )       ($2.26   )       ($2.81   )
  diluted
                                                                       
Weighted average
shares
outstanding:
  Basic and            22,744           3,439           10,112           3,348
  diluted




Contact:

Agios Pharmaceuticals, Inc.
Glenn Goddard
SVP Finance
investors@agios.com
or
Media Contact:
Dan Budwick, 973-271-6085
dan@purecommunicationsinc.com
 
Press spacebar to pause and continue. Press esc to stop.