Agios Reports Business Highlights and First Quarter 2021 Financial Results
April 29 2021 - 7:00AM
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field
of cellular metabolism to treat genetically defined diseases, today
reported business highlights and financial results for the first
quarter ended March 31, 2021.
“With the recent closing of the sale of our oncology business,
we are excited to embrace a focused future in genetically defined
diseases,” said Jackie Fouse, Ph.D., chief executive officer at
Agios. “In the weeks and months ahead, we look forward to a number
of important catalysts, beginning with presentations at the EHA
2021 Virtual Congress, where we will share data from our ACTIVATE
and ACTIVATE-T studies of mitapivat in adults with pyruvate kinase
(PK) deficiency, as well as data from our Phase 2 study of
mitapivat in thalassemia. The PK deficiency data will form the
basis of our upcoming submissions for regulatory approval in the
U.S. this quarter and in the EU mid-year. Additionally, we look
forward to further exploring the impact of mitapivat in thalassemia
and sickle cell disease as we launch two Phase 3 studies and a
Phase 2/3 study, respectively, later this year. The courage and
needs of the patients and families that we seek to serve continue
to be our great motivation, and we are proud of our recent
educational and patient-focused efforts that aim to make a
meaningful impact on rare hemolytic anemia communities.”
FIRST QUARTER 2021 & RECENT HIGHLIGHTS
- Closed the sale of commercial, clinical and research-stage
oncology portfolio to Servier Pharmaceuticals, LLC, on March 31,
2021.
- Initiated the repurchase of up to $1.2 billion of outstanding
shares, as authorized by the board of directors, and entered into a
definitive agreement with Bristol-Myers Squibb Company (BMS) to
repurchase 7,121,658 shares of Agios common stock held by BMS and
its affiliates for an aggregate purchase price of $344.5 million,
or $48.38 per share. Agios expects to execute a meaningful portion
of the planned repurchases by year-end through a combination of
10b5-1 plans and open market purchases.
- Supported several educational and patient-focused initiatives,
including the sponsorship of a health literacy program for sickle
cell disease and the launch of a collaboration with 23andMe that
led to addition of the very first PK deficiency carrier status
report.
KEY UPCOMING MILESTONES
- Finalize global regulatory filings for mitapivat in adults with
PK deficiency; submit new drug application (NDA) in the U.S. in the
second quarter of 2021 and marketing authorization application
(MAA) in the EU in mid-2021.
- Initiate two Phase 3 studies of mitapivat, ENERGIZE and
ENERGIZE-T, in not regularly transfused and regularly transfused
adults with thalassemia in the second half of 2021.
- Initiate Phase 2/3 study of mitapivat in sickle cell disease by
year-end.
- Prioritize new indications for pyruvate kinase R (PKR) and
pyruvate kinase M2 (PKM2) activator clinical development by
year-end.
Data Presentations
- Present data from the following clinical studies for
presentation at the EHA Virtual Congress, hosted June
9-17, 2021:
- Phase 3 ACTIVATE study of mitapivat in adults with PK
deficiency who do not receive regular transfusions
- Phase 3 ACTIVATE-T study of mitapivat in adults with PK
deficiency who receive regular transfusions
- Phase 2 study of mitapivat in adults with α- and β-thalassemia
who do not receive regular transfusions
- Submit data from ongoing clinical studies of mitapivat in
sickle cell disease for presentation at medical meetings in
2021.
- Present data from the Phase 1 study of AG-946, the company's
next-generation PKR activator, in healthy volunteers by
year-end.
FIRST QUARTER 2021 FINANCIAL RESULTS
Research and Development (R&D)
Expenses: R&D expenses for continuing operations
were $57.7 million for the first quarter of 2021 compared
to $55.4 million for the first quarter of 2020. The
year-over-year increase in R&D was driven primarily by start-up
costs associated with the Phase 3 studies of mitapivat in
thalassemia and sickle cell disease.
Selling, General and Administrative (SG&A)
Expenses: SG&A expenses for continuing operations
were $33.6 million for the first quarter of 2021 compared
to $31.7 million for the first quarter of 2020. The
year-over-year increase in SG&A expenses was primarily
attributable to one-time workforce expense.
Discontinued Operations: Due to the sale
of the oncology business during the first quarter of 2021, we have
reclassified the results of the oncology business as discontinued
operations, including total revenue of $41.4 million, TIBSOVO® net
sales of $37 million, and operating expenses of $50.2 million
related to discontinued operations.
Net Income: Net income was $1.9
billion for the first quarter of 2021 compared to a net loss
of $40.3 million for the first quarter of 2020.
Cash Position and Guidance: Cash, cash
equivalents and marketable securities as of March 31,
2021 were $2.4 billion compared to $613.1
million as of March 31, 2020. The company expects that
its cash, cash equivalents and marketable securities as of March
31, 2021, together with anticipated interest income, future product
sales and TIBSOVO® royalties, will enable the company to fund its
planned operating expenses and capital expenditure requirements
through major catalysts and to cash-flow positivity without the
need to raise additional equity.
CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides
today at 8:00 a.m. ET to discuss first quarter 2021
financial results 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 4497151.
The live webcast can be accessed under “Events & Presentations”
in the Investors 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 AgiosAgios is focused on discovering and
developing novel investigational medicines to treat genetically
defined diseases through scientific leadership in the field of
cellular metabolism. The company’s most advanced drug candidate is
a first-in-class pyruvate kinase R (PKR) activator, mitapivat, that
is currently being evaluated for the treatment of three distinct
hemolytic anemias. In addition to its active late-stage clinical
pipeline, Agios has multiple novel, investigational therapies in
clinical and preclinical development. For more information, please
visit the company’s website at www.agios.com.
Cautionary Note Regarding Forward-Looking
StatementsThis 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’ plans, strategies and expectations for the
preclinical, clinical and commercial advancement of its drug
development programs, including mitapivat; the potential benefits
of Agios’ products and product candidates; Agios’ key milestones
and guidance for 2021; its financial guidance regarding the period
in which it will have capital available to fund its operations;
expectations regarding the return of capital to shareholders
following the sale of Agios’ oncology business; and the potential
benefits of Agios’ strategic plans and focus. The words
“anticipate,” “expect,” “goal,” “hope,” “milestone,” “plan,”
“potential,” “possible,” “strategy,” “will,” “vision,” 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. 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, without limitation risks and
uncertainties related to: the failure of Agios to receive milestone
or royalty payments related to the sale of its oncology business,
the uncertainty of the timing of any receipt of any such payments,
and the uncertainty of the results and effectiveness of the use of
proceeds from the transaction; the impact of the COVID-19 pandemic
to Agios’ business, operations, strategy, goals and anticipated
milestones, including its ongoing and planned research activities,
ability to conduct ongoing and planned clinical trials, clinical
supply of current or future drug candidates, commercial supply of
future approved products, and launching, marketing and selling
future approved products; 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, the EMA or 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 and competitive factors; Agios’ ability to obtain,
maintain and enforce patent and other intellectual property
protection for any product candidates it is developing; Agios’
ability to establish and maintain collaborations; and general
economic and market conditions. These and other risks are described
in greater detail under the caption “Risk Factors” included in
Agios’ public filings with the Securities and Exchange Commission,
or SEC, including the risks and uncertainties set forth under the
heading Risk Factors in our filings with the SEC. While the list of
factors presented here is considered representative, this list
should not be considered to be a complete statement of all
potential risks and uncertainties. Any forward-looking statements
contained in this communication are made only as of the date
hereof, and we undertake no obligation to update forward-looking
statements to reflect developments or information obtained after
the date hereof and disclaim any obligation to do so other than as
may be required by law.
ContactHolly Manning, 617-844-6630Senior
Director, Investor RelationsHolly.Manning@agios.com
|
Consolidated Balance Sheet Data |
(in thousands) |
(Unaudited) |
|
|
March 31,2021 |
|
December 31,2020 |
Cash, cash equivalents and marketable securities |
$ |
2,357,201 |
|
$ |
670,537 |
Assets held for discontinued
operations |
|
- |
|
|
50,460 |
Total assets |
|
2,488,434 |
|
|
852,952 |
Liabilities held for
discontinued operations |
|
- |
|
|
299,728 |
Stockholders' equity |
|
2,296,630 |
|
|
399,500 |
|
|
Consolidated Statements of Operations Data |
(in thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
Three MonthsEnded March 31, |
|
|
|
2021 |
|
|
|
2020 |
|
Cost and expenses: |
|
|
|
Research and development |
$ |
57,667 |
|
|
$ |
55,358 |
|
Selling, general and administrative |
$ |
33,550 |
|
|
$ |
31,672 |
|
Total
cost and expenses |
$ |
91,217 |
|
|
$ |
87,030 |
|
Loss from operations |
$ |
(91,217 |
) |
|
$ |
(87,030 |
) |
Interest income, net |
$ |
340 |
|
|
$ |
2,936 |
|
Net loss from continuing
operations |
$ |
(90,877 |
) |
|
$ |
(84,094 |
) |
Net
income from discontinued operations, net of tax |
$ |
1,965,202 |
|
|
$ |
43,838 |
|
Net
Income (loss) |
$ |
1,874,325 |
|
|
$ |
(40,256 |
) |
Net (loss) from continuing
operations per share - basic and diluted |
$ |
(1.31 |
) |
|
$ |
(1.23 |
) |
Net income from discontinued
operations per share - basic and diluted |
$ |
28.26 |
|
|
$ |
0.64 |
|
Net
income (loss) per share - basic and diluted |
$ |
26.95 |
|
|
$ |
(0.59 |
) |
Weighted-average number of
common shares used in computing net income (loss) per share – basic
and diluted |
|
69,543,510 |
|
|
|
68,608,279 |
|
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