AnaptysBio Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Pipeline Updates
February 25 2021 - 3:05PM
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology
company developing first-in-class antibody product candidates
focused on emerging immune control mechanisms applicable to
inflammation and immuno-oncology indications, today reported
operating results for the fourth quarter and year ended December
31, 2020 and provided pipeline updates.
“We made progress in advancing AnaptysBio’s pipeline during 2020
and look forward to multiple clinical readouts from our
wholly-owned programs in 2021. Imsidolimab will continue to be our
key focus going forward as we anticipate GPP Phase 3 initiation and
Phase 2 topline readouts from five other immune-dermatology
indications through 2021 and 2022. We also anticipate commercial
launch of dostarlimab this year and meaningful milestone and
royalty revenue to AnaptysBio under our GSK partnership,” said
Hamza Suria, president and chief executive officer of AnaptysBio.
“Our strategy is to continue advancing first-in-class
immunology-focused therapeutic antibodies through key clinical data
catalysts using a capital-efficient business model.”
Imsidolimab (Anti-IL-36 Receptor) Program
- In July, we announced that the U.S.
Food and Drug Administration (FDA) has granted orphan drug
designation for imsidolimab, our proprietary anti-interleukin-36
receptor (IL-36R) antibody, for the treatment of patients with
GPP.
- In October, we announced positive
topline data from an interim analysis of our imsidolimab GALLOP
Phase 2 trial in GPP. Six of 8 patients achieved the primary
endpoint of disease improvement upon Day 29, while erythema with
skin pustules, which clinically defines GPP, decreased by 94% on
Day 29 relative to baseline. We plan to report 16-week data from
the GALLOP trial at a medical conference in 2021.
- We anticipate initiation of a Phase 3
trial for imsidolimab in GPP during mid-2021 following completion
of protocol alignment, and review of 16-week data from the Phase 2
GALLOP trial, with the FDA.
- We are also conducting a randomized,
placebo-controlled, multi-dose Phase 2 trial in 59 patients with
palmoplantar pustulosis, or PPP, also known as the POPLAR trial,
with topline data anticipated in Q1 2021.
- We have expanded our imsidolimab
program into third and fourth new clinical indications,
EGFRi-mediated skin toxicities and ichthyosis, with interim
top-line data from Phase 2 trials anticipated at the end of 2021
and in 2022, respectively, and we are also expanding the
imsidolimab program into fifth and sixth new clinical indications,
hidradenitis suppurativa and acne, with initiation of Phase 2
trials in these indications anticipated in Q2 2021.
- We initiated a worldwide registry of
GPP and PPP patients, named RADIANCE, in Q1 2021, to improve
understanding of the patient journey and support enrollment of
future trials.
ANB030 (Anti-PD-1 Agonist) Program
- We anticipate topline data from our
ongoing Phase 1 healthy volunteer clinical trial of ANB030, our
wholly-owned PD-1 agonist antibody, designed to assess the safety,
pharmacokinetics and pharmacodynamics of ANB030 in single and
multiple ascending dose cohorts in mid-2021.
- Preclinical translational data using
ANB030 was presented in March 2020 at the Festival of Biologics
Meeting.
- We anticipate initiating Phase 2
trials of ANB030 in alopecia areata and vitiligo in Q4
2021.
ANB032 (Anti-BTLA Modulator) Program
- We filed a Clinical Trial Notification
(“CTN”) in Australia for ANB032, our wholly-owned BTLA modulator
antibody, during the first quarter of 2021 and anticipate
initiating a healthy volunteer Phase 1 trial in the first half of
2021 upon clearance of the CTN.
- We presented preclinical data
regarding ANB032 at the 2020 Federation of Clinical Immunology
Societies (FOCIS) Virtual Annual Meeting in October 2020.
Etokimab (ANB020 Anti-IL-33) Program
- We discontinued further development of
etokimab, our anti-IL-33 antibody previously referred to as ANB020,
following review of topline week 16 data from the approximately
100-patient ECLIPSE trial in chronic rhinosinusitis with nasal
polyps (CRSwNP), where patients dosed with etokimab every four
(q4w) or eight weeks (q8w) failed to achieve statistically
significant over placebo on either co-primary
endpoint.
Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with
GSK
- In October 2020, we amended our
immuno-oncology collaboration with GSK resulting in increased
financial consideration to AnaptysBio. Royalties due to AnaptysBio
for dostarlimab were increased to 8-25% of global net sales, where
AnaptysBio will receive 8% of annual global net sales below $1
billion, and 12-25% of net sales above $1 billion. The $1.1 billion
in cash milestone payments due under the collaboration agreement
remain unchanged, and AnaptysBio anticipates receiving $75 million
in such cash milestones over the next 18 months as dostarlimab
obtains FDA and EMA regulatory approval for the first two
indications. An additional $165 million in sales milestones is
anticipated by AnaptysBio upon achievement of certain dostarlimab
annual sales revenues. GSK also agreed, starting January 1, 2021,
to pay AnaptysBio a 1% royalty on all of GSK’s global net sales of
Zejula. In addition, GSK paid AnaptysBio a one-time cash payment of
$60 million in Q4 2020. In exchange, AnaptysBio
provided GSK with freedom to conduct development and
commercialization of Zejula in combination with third-party
molecules and settled the dispute between AnaptysBio and GSK.
- US BLA and European Union EMA
approvals for dostarlimab are anticipated for endometrial cancer in
H1 2021, which will result in $20 million and $10 million milestone
payments, respectively. The FDA recently accepted a
subsequent US BLA for dostarlimab in pan-deficient mismatch repair
tumors and we anticipate receiving a $10 million payment from GSK
in Q1 2021 as a result of this milestone.
Board of Directors
- In January 2021, the Company appointed
Dr. Magda Marquet to its board of directors. She is the co-founder
of AltheaDx, a commercial stage, precision medicine company, and
co-founded Althea Technologies and as its co-CEO led the company to
become a highly profitable, commercial company. Prior to starting
Althea Technologies, Dr. Marquet held several positions in
pharmaceutical development in companies such as Vical and Amylin
Pharmaceuticals. She currently serves on the Board of Directors of
Arcturus Therapeutics, Micronoma, Matrisys Biosciences and
ProciseDx.
Fourth Quarter Financial Results
- Cash, cash equivalents and investments
totaled $411.2 million as of December 31, 2020 compared to
$428.5 million as of December 31, 2019, for a net decrease of
$17.3 million. The decrease relates primarily to cash used for
operating activities partially offset by an increase in
collaboration revenue of $67.0 million.
- Collaboration revenue was $60.0
million and $75.0 million for the three and twelve months ended
December 31, 2020, which related to milestone payments for
successful BLA and MAA filings for dostarlimab and the $60.0
million amendment related payment from GSK, compared to $3.0
million and $8.0 million for the three and twelve months ended
December 31, 2019.
- Research and development expenses were
$21.6 million and $80.0 million for the three and twelve months
ended December 31, 2020, compared to $21.4 million and $99.3
million for the three and twelve months ended December 31,
2019. The annual decrease was due primarily to reduced outside
services for manufacturing and clinical activities based on the
timing of projects.
- General and administrative expenses
were $5.1 million and $18.9 million for the three and twelve months
ended December 31, 2020, compared to $3.8 million and $16.1
million for the three and twelve months ended December 31,
2019. The increase was due primarily to increased legal and
insurance expenses.
- Net income was $33.6 million for the
three months ended December 31, 2020, or a net income per
share of $1.23 and a net loss of $19.9 million for the twelve
months ended December 31, 2020, or a net loss per share of
$0.73, compared to a net loss of $20.3 million and $97.3 million
for the three and twelve months ended December 31, 2019, or a
net loss per share of $0.75 and $3.60.
Financial Guidance
AnaptysBio expects its net cash burn in 2021 will be close to
$100 million. We anticipate that our cash, cash equivalents and
anticipated revenues will fund our current operating plan at least
into 2024.
About AnaptysBioAnaptysBio is a clinical-stage
biotechnology company developing first-in-class antibody product
candidates focused on emerging immune control mechanisms applicable
to inflammation and immuno-oncology indications. The Company’s
proprietary anti-inflammatory pipeline includes its anti-IL-36R
antibody imsidolimab, previously referred to as ANB019, for the
treatment of rare inflammatory diseases, including generalized
pustular psoriasis, or GPP, palmoplantar pustulosis, or PPP, EGFRi,
ichthyosis, hidradenitis suppurativa and acne; its anti-PD-1
agonist program, ANB030, for treatment of certain autoimmune
diseases where immune checkpoint receptors are insufficiently
activated; and its BTLA modulator program, ANB032, which is broadly
applicable to human inflammatory diseases associated with lymphoid
and myeloid immune cell dysregulation. AnaptysBio’s antibody
pipeline has been developed using its proprietary somatic
hypermutation, or SHM platform, which uses in vitro SHM for
antibody discovery and is designed to replicate key features of the
human immune system to overcome the limitations of competing
antibody discovery technologies. AnaptysBio has also developed
multiple therapeutic antibodies in an immuno-oncology collaboration
with GlaxoSmithKline, including an anti-PD-1 antagonist antibody
(dostarlimab GSK4057190A), an anti-TIM-3 antagonist antibody
(cobolimab, GSK4069889A) and an anti-LAG-3 antagonist antibody
(GSK4074386), and an inflammation collaboration with Bristol-Myers
Squibb, including an anti-PD-1 checkpoint agonist antibody
(CC-90006) currently in clinical development.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995, including, but not limited to: the timing of the release
of data from our clinical trials, including imsidolimab’s Phase 2
clinical trial in PPP, imsidolimab’s Phase 2 clinical trials in
EGFRi, ichthyosis, hidradenitis suppurativa, and acne, and ANB030’s
Phase 1 healthy volunteer clinical trial; the timing of initiation
of imsidolimab’s Phase 2 clinical trials in hidradenitis
suppurativa and acne; the timing of initiation of imsidolimab’s
Phase 3 clinical trial in GPP; the timing of initiation of ANB032’s
Phase 1 healthy volunteer clinical trial; the milestones and
royalty payments to be received under the GSK collaboration; and
our projected 2021 cash burn and cash runway. Statements including
words such as “plan,” “continue,” “expect,” or “ongoing” and
statements in the future tense are forward-looking statements.
These forward-looking statements involve risks and uncertainties,
as well as assumptions, which, if they do not fully materialize or
prove incorrect, could cause our results to differ materially from
those expressed or implied by such forward-looking statements.
Forward-looking statements are subject to risks and uncertainties
that may cause the company’s actual activities or results to differ
significantly from those expressed in any forward-looking
statement, including risks and uncertainties related to the
company’s ability to advance its product candidates, obtain
regulatory approval of and ultimately commercialize its product
candidates, the timing and results of preclinical and clinical
trials, the company’s ability to fund development activities and
achieve development goals, the company’s ability to protect
intellectual property and other risks and uncertainties described
under the heading “Risk Factors” in documents the company files
from time to time with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date of this
press release, and the company undertakes no obligation to revise
or update any forward-looking statements to reflect events or
circumstances after the date hereof.
Contact:Dennis MulroyAnaptysBio, Inc.
858.732.0201dmulroy@anaptysbio.com
AnaptysBio,
Inc.Consolidated Balance Sheets
(in thousands, except par value)
|
December 31, 2020 |
|
December 31, 2019 |
|
|
|
|
ASSETS |
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
250,456 |
|
|
|
$ |
171,017 |
|
|
Short-term investments |
143,197 |
|
|
|
203,210 |
|
|
Prepaid expenses and other
current assets |
2,908 |
|
|
|
3,506 |
|
|
Total current assets |
396,561 |
|
|
|
377,733 |
|
|
Property and equipment, net |
1,783 |
|
|
|
1,618 |
|
|
Long-term investments |
17,546 |
|
|
|
54,305 |
|
|
Other long-term assets |
602 |
|
|
|
1,481 |
|
|
Restricted cash |
60 |
|
|
|
60 |
|
|
Total assets |
$ |
416,552 |
|
|
|
$ |
435,197 |
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
Current liabilities: |
|
|
|
Accounts payable |
$ |
4,217 |
|
|
|
$ |
16,237 |
|
|
Accrued expenses |
15,262 |
|
|
|
11,052 |
|
|
Notes payable, current
portion |
— |
|
|
|
1,375 |
|
|
Other current liabilities |
342 |
|
|
|
871 |
|
|
Total current liabilities |
19,821 |
|
|
|
29,535 |
|
|
Other long-term liabilities |
— |
|
|
|
654 |
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.001 par
value, 10,000 shares authorized and no shares, issued or
outstanding at December 31, 2020 and December 31, 2019,
respectively |
— |
|
|
|
— |
|
|
Common stock, $0.001 par
value, 500,000 shares authorized, 27,356 shares and 27,255 shares
issued and outstanding at December 31, 2020 and December 31, 2019,
respectively |
27 |
|
|
|
27 |
|
|
Additional paid in capital |
660,665 |
|
|
|
648,669 |
|
|
Accumulated other comprehensive
(loss) income |
(4 |
) |
|
|
338 |
|
|
Accumulated deficit |
(263,957 |
) |
|
|
(244,026 |
) |
|
Total
stockholders’ equity |
396,731 |
|
|
|
405,008 |
|
|
Total liabilities and stockholders’ equity |
$
416,552 |
|
|
|
$
435,197 |
|
|
AnaptysBio,
Inc.Consolidated Statements of Operations and
Comprehensive Income (Loss)(in thousands, except
per share data)
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Collaboration revenue |
$ |
60,000 |
|
|
|
$ |
3,000 |
|
|
|
$ |
75,000 |
|
|
|
$ |
8,000 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
21,567 |
|
|
|
21,426 |
|
|
|
80,025 |
|
|
|
99,338 |
|
|
General and administrative |
5,088 |
|
|
|
3,832 |
|
|
|
18,854 |
|
|
|
16,094 |
|
|
Total operating expenses |
26,655 |
|
|
|
25,258 |
|
|
|
98,879 |
|
|
|
115,432 |
|
|
Income (loss) from operations |
33,345 |
|
|
|
(22,258 |
) |
|
|
(23,879 |
) |
|
|
(107,432 |
) |
|
Other income (expense), net: |
|
|
|
|
|
|
|
Interest expense |
— |
|
|
|
(200 |
) |
|
|
— |
|
|
|
(1,041 |
) |
|
Interest income |
376 |
|
|
|
2,282 |
|
|
|
3,959 |
|
|
|
10,984 |
|
|
Other (expense) income, net |
(75 |
) |
|
|
(109 |
) |
|
|
(11 |
) |
|
|
1 |
|
|
Total other income (expense), net |
301 |
|
|
|
1,973 |
|
|
|
3,948 |
|
|
|
9,944 |
|
|
Income (loss) before income
taxes |
33,646 |
|
|
|
(20,285 |
) |
|
|
(19,931 |
) |
|
|
(97,488 |
) |
|
Provision for income taxes |
— |
|
|
|
22 |
|
|
|
— |
|
|
|
152 |
|
|
Net income (loss) |
33,646 |
|
|
|
(20,263 |
) |
|
|
(19,931 |
) |
|
|
(97,336 |
) |
|
Other comprehensive (loss)
income: |
|
|
|
|
|
|
|
Unrealized (loss) income on available for sale securities, net of
tax of $0, ($36), $0, and $153, respectively |
(263 |
) |
|
|
(142 |
) |
|
|
(342 |
) |
|
|
561 |
|
|
Comprehensive income (loss) |
$ |
33,383 |
|
|
|
$ |
(20,405 |
) |
|
|
$ |
(20,273 |
) |
|
|
$ |
(96,775 |
) |
|
Net income (loss) per common
share: |
|
|
|
|
|
|
|
Basic |
$ |
1.23 |
|
|
|
$ |
(0.75 |
) |
|
|
$ |
(0.73 |
) |
|
|
$ |
(3.60 |
) |
|
Diluted |
$ |
1.20 |
|
|
|
$ |
(0.75 |
) |
|
|
$ |
(0.73 |
) |
|
|
$ |
(3.60 |
) |
|
Weighted-average number of shares
outstanding: |
|
|
|
|
|
|
|
Basic |
27,349 |
|
|
|
27,154 |
|
|
|
27,302 |
|
|
|
27,059 |
|
|
Diluted |
27,938 |
|
|
|
27,154 |
|
|
|
27,302 |
|
|
|
27,059 |
|
|
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