Agios Pharmaceuticals Reports Fourth Quarter and Full Year 2013 Financial Results
Pipeline Advancing with Additional Programs Moving into Clinical Development
“In 2013, we continued to apply our scientific and clinical leadership
in the field of cellular metabolism towards our goal of transforming the
lives of patients with cancer and inborn errors of metabolism,” said
Recent Business Highlights
Continued enrollment and dose escalation in the Phase 1 study of
AG-221, an IDH2 mutant inhibitor for the treatment of cancer in
patients 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. 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. Agios expects to present
initial clinical data from the dose escalation portion of the ongoing
Phase 1 study of AG-221 at the 2014
American Association for Cancer ResearchAnnual Meeting (AACR) in early April.
Completed investigational new drug (IND) filing for AG-120, an IDH1
mutant inhibitor for the treatment of cancer in patients with an IDH1
The Food and Drug Administration( FDA) recently accepted Agios’ IND for AG-120, and the company remains on track to initiate two Phase 1 clinical trials in early 2014. AG-120 is an orally available, selective, potent inhibitor of the mutated IDH1 protein, and has been demonstrated to be a highly targeted therapeutic candidate for the treatment of patients with cancers that harbor an IDH1 mutation.
Exercised the option to U.S. rights to AG-120. Agios elected to
exercise the option to U.S. development and commercial rights for
AG-120, in accordance with the terms of its agreement with
Celgene Corporation, with Celgeneretaining its option to ex-U.S. rights.
Advanced AG-348, an activator of pyruvate kinase R (PKR) for the treatment of patients with pyruvate kinase deficiency (PK deficiency), toward clinical development. Agios has completed IND-enabling studies of AG-348 and expects to initiate Phase 1 clinical trials for AG-348 in mid-2014. AG-348 is an orally available, potent, selective small molecule activator of the PKR enzyme, which, when mutated, leads to PK deficiency, a form of hereditary hemolytic anemia.
Extended cancer metabolism collaboration with
Celgene. In December, Agios announced an extension of one additional year to the period of exclusivity for its strategic cancer metabolism collaboration with Celgene. As a result, the exclusive research collaboration between Agios and Celgenehas been extended through April 2015, and Agios will receive a $20 millionextension payment to be paid mid-2014.
Agios expects to present initial clinical data from the dose
escalation portion of the ongoing Phase 1 study of AG-221 at the 2014
American Association for Cancer ResearchAnnual Meeting (AACR) in early April. Agios expects to continue enrollment in its Phase 1 study of AG-221 and initiate expansion cohorts in late 2014.
- Agios plans to initiate two Phase 1 clinical trials for AG-120 in early 2014 (one in advanced solid tumors and one in hematologic malignancies) in patients whose cancers carry an IDH1 mutation. These studies will leverage the clinical trial sites of Agios’ Phase 1 study of AG-221.
- Agios anticipates initiating single and multiple ascending dose-escalation studies for AG-348 in healthy volunteers in mid-2014.
Fourth Quarter 2013 Financial Results & Financial Guidance
Cash Position: Cash, cash equivalents and marketable securities
December 31, 2013were $193.9 million, compared to $128.0 millionas of December 31, 2012. The increase was primarily driven by net proceeds of $111.0 millionfrom Agios’ IPO and $12.8 millionfrom the concurrent private placement with Celgene, offset by cash used to fund operations.
Revenues: Collaboration revenue was
$6.7 millionfor the fourth quarter of 2013 and $25.5 millionfor the year ended December 31, 2013,compared to $6.3 millionand $25.1 millionin the comparable periods in 2012. Collaboration revenue is primarily comprised of amortization of deferred revenue from payments received in previous periods from Agios’ collaboration agreement with Celgene.
R&D Expenses: Research and development expenses were
$15.3 millionin the fourth quarter of 2013 and $54.5 millionfor the year ended December 31, 2013, compared to $11.2 millionand $41.0 millionin 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, and as the company prepares to begin clinical development of AG-120 in early 2014, as well as IND-enabling activities for the company’s AG-348 program.
G&A Expenses: General and administrative expenses were
$3.7 millionin the fourth quarter of 2013 and $9.9 millionin the year ended December 31, 2013, compared to $1.6 millionand $7.1 millionin 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
$12.4 millionfor the fourth quarter of 2013 and $39.4 millionfor the year ended December 31, 2013, compared to net loss of $5.3 millionand $20.1 millionfor 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 late 2016.
“Agios continues to maintain a strong balance sheet, ending 2013 with
Conference Call Information
Agios will host a conference call and live audio webcast today at
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,
AGIOS PHARMACEUTICALS, INC.
|CONSOLIDATED BALANCE SHEET DATA (UNAUDITED)|
|(Amounts in thousands)|
|December 31,||December 31,|
|Cash, cash equivalents, and marketable securities||$193,894||$127,976|
|Stockholders' equity (deficit)||131,482||(72,024)|
|AGIOS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)|
|(Amounts in thousands except per share data)|
Three Months Ended
Twelve Months Ended
|Research and development||15,279||11,226||54,502||41,037|
|General and administrative||3,707||1,554||9,929||7,064|
|Total operating expenses||18,986||12,780||64,431||48,101|
|Loss from operations||(12,242)||(6,498)||(38,883)||(22,995)|
|(Provision) benefit for income taxes||(169)||1,176||(579)||2,824|
|Cumulative preferred stock dividends||-||
|Net loss applicable to common stockholders||($12,382)||
|Net loss per share applicable to common stockholders:|
|Basic and diluted||($0.40)||($2.09)||($2.83)||($8.02)|
|Weighted average shares outstanding:|
|Basic and diluted||31,153||3,402||15,415||3,402|