Achieves Record IXINITY® Net Revenue with 94%
Increase inYear-Over-Year Quarterly Revenue
Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company
focused on developing novel oncology and hematology therapeutics,
today provided a business review and reported its financial results
for the second quarter ended June 30, 2018.
“We are very gratified with IXINITY’s sales
performance,” said Marvin L. White, President and Chief Executive
Officer. “In the first and second quarters of 2018 we
achieved record net revenues for IXINITY demonstrating a 93% and
94% increase, respectively, in year-over-year quarterly IXINITY
revenue. We are pleased with the acceptance of IXINITY in the
marketplace. Our messages and value proposition appear to be
resonating well with the Hemophilia B community and we are actively
continuing our efforts to onboard new patients on IXINITY therapy.”
“I am especially impressed with the progress we
continue to make advancing our ADAPTIR bispecific candidates.
During the second quarter we filed an investigational new drug
(IND) application for APVO436 and are on track to commence patient
dosing in the fourth quarter of 2018 in a Phase 1 clinical study of
APVO436 in acute myeloid leukemia (AML). The accumulating
preclinical data for APVO436 are increasingly compelling, and
suggest that APVO436 has best-in-class potential among
CD123-targeting bispecific molecules. New preclinical data
presented by Aptevo scientists at this year’s American Association
for Cancer Research Annual Meeting demonstrated APVO436’s ability
to stimulate potent T-cell directed tumor killing, importantly,
with reduced cytokine production compared to an Aptevo-generated
version of a competitor bispecific molecule. We are very encouraged
by these data and look forward to commencing clinical evaluation of
APVO436 later this year.”
“Also during the second quarter, new preclinical
data on our autoimmune bispecific candidate, APVO210, were
published in Frontiers in Immunology supporting targeted cytokine
delivery as a novel therapeutic approach for inflammatory and
autoimmune diseases and showing how APVO210 has a unique mechanism
of action, retaining the immunosuppressive function of the cytokine
IL-10, without its undesired immunostimulatory properties – a key
advantage with this molecule. We anticipate beginning a Phase
1 clinical trial of APVO210 in the first quarter of 2019.”
“Having addressed the major industry challenges
associated with bispecific antibodies, including stability,
manufacturability and half-life, Aptevo’s next generation ADAPTIR
bispecific platform is at the forefront of this exciting new field
of immunotherapies and we look forward to advancing APVO436 and
APVO210 into clinical development,” concluded Mr. White.
Second Quarter 2018
Highlights
- Achieved record quarterly IXINITY net revenue with second
quarter 2018 IXINITY revenue increasing 94% from the same period in
2017
- Expanded the patient base for IXINITY, bringing additional new
Hemophilia B patients onto IXINITY therapy during the quarter
- Continued enrollment in a Phase 2, two-part, open-label,
proof-of-concept clinical study of otlertuzumab in patients with
relapsed or refractory peripheral T-cell lymphoma to evaluate the
safety and efficacy of otlertuzumab in combination with
bendamustine; top-line preliminary data readout anticipated at the
end of the year
- Continued enrollment in a dose escalation Phase 1 clinical
study of APVO414, a novel bispecific antibody being developed for
the treatment of metastatic castration-resistant prostate cancer;
top-line preliminary data readout anticipated at the end of the
year
- Presented comprehensive new preclinical data for APVO436 at the
American Association for Cancer Research (AACR) Annual Meeting
demonstrating potent T cell-directed tumor killing with reduced
cytokine release in preclinical studies compared to an
Aptevo-generated competitor bispecific construct
- Filed an IND application with the U.S. Food and Drug
Administration for APVO436; commenced site activation for the Phase
1 clinical trial; anticipate patient dosing will commence in the
fourth quarter of 2018
- Published comprehensive preclinical data in the journal,
Frontiers in Immunology, showing that APVO210 has a unique
mechanism of action for delivering the cytokine, IL-10, which can
generate antigen specific T-regulatory cells, and suppress
inflammation and immune activation without stimulating
pro-inflammatory cytokines
- Continued preparations to begin a Phase 1 clinical study of
APVO210 in the first quarter of 2019
- Presented new preclinical data for ALG.APV-527 at prominent
industry conferences showing that it has the potential to
selectively activate and enhance tumor-specific T cell responses at
the tumor site without triggering systemic immune activation,
supporting the advantages of this novel pathway for tumor
immunotherapy
Second Quarter 2018 Financial
Results
Cash Position: Aptevo had
cash, cash equivalents, and short-term investments as of June 30,
2018 totaling $57.6 million.
IXINITY Revenue: Product
sales of IXINITY increased by $3.3 million, or 94%, to $6.8 million
for the three months ended June 30, 2018, compared to $3.5 million
for the same period in 2017. The increase was related to the
expansion of Aptevo’s distribution channel and continuing expansion
of the Hemophilia B patient base for IXINITY.
Cost of Product Sales:
Cost of product sales decreased by 15% to $2.5 million for the
three months ended June 30, 2018, compared to $3.0 million for the
three months ended June 30, 2017. This decrease was primarily
due to the sale of IXINITY inventory received without any cash
costs being incurred due to product being received in settlement
against outstanding inventory credit.
Research and Development
Expenses: Research and development expenses
increased by $2.9 million, to $9.7 million for the three months
ended June 30, 2018, compared to $6.8 million for the corresponding
period in 2017. The increase was primarily attributable to
increased expenses related to manufacturing and clinical start-up
costs for APVO210 and APVO436, as well as ongoing research and
discovery efforts as Aptevo continued to evaluate new preclinical
ADAPTIR bispecific candidates.
Selling, General and Administrative
Expenses: Selling, general and administrative
expenses decreased by $1.4 million, or 17%, to $7.0 million for the
three months ended June 30, 2018, compared to $8.4 million for the
same period in 2017. The decrease in SG&A expenses in the
second quarter of 2018 was primarily due to reduced personnel and
professional services costs.
Net Loss: Aptevo’s net
loss for the three months ended June 30, 2018 was $13.1 million or
($0.58) per share, compared to $11.2 million or ($0.53) per share
for the corresponding period in 2017. The change in net loss
year-over-year is primarily due to approximately $3.0 million in
income from discontinued operations recorded in the second quarter
of 2017 and related to the sale of Aptevo’s hyperimmune
business.
Financial Statements Follow
Aptevo Therapeutics
Inc.CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share and per share
amounts, unaudited)
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
June 30, 2018 |
|
|
December 31, 2017 |
|
Cash and
cash equivalents |
|
$ |
7,228 |
|
|
$ |
7,095 |
|
Short-term investments |
|
|
37,503 |
|
|
|
73,688 |
|
Accounts
receivable |
|
|
6,145 |
|
|
|
2,141 |
|
Inventories |
|
|
2,970 |
|
|
|
1,028 |
|
Prepaid
expenses |
|
|
4,863 |
|
|
|
4,022 |
|
Other
current assets |
|
|
7,138 |
|
|
|
6,710 |
|
Restricted cash |
|
|
400 |
|
|
|
400 |
|
Total
current assets |
|
|
66,247 |
|
|
|
95,084 |
|
Restricted cash, net of current portion |
|
|
12,447 |
|
|
|
10,000 |
|
Property
and equipment, net |
|
|
5,638 |
|
|
|
5,843 |
|
Intangible assets, net |
|
|
5,665 |
|
|
|
6,080 |
|
Total
assets |
|
$ |
89,997 |
|
|
$ |
117,007 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and other accrued liabilities |
|
$ |
9,535 |
|
|
$ |
7,350 |
|
Accrued
compensation |
|
|
2,685 |
|
|
|
4,626 |
|
Sales
rebates and discounts payable |
|
|
953 |
|
|
|
623 |
|
Current
portion of long-term debt |
|
|
4,167 |
|
|
|
3,333 |
|
Other
short-term liabilities |
|
|
762 |
|
|
|
2,578 |
|
Total
current liabilities |
|
|
18,102 |
|
|
|
18,510 |
|
Long-term
debt, net |
|
|
15,400 |
|
|
|
15,728 |
|
Other
liabilities |
|
|
465 |
|
|
|
734 |
|
Total
liabilities |
|
|
33,967 |
|
|
|
34,972 |
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
|
|
Preferred stock: $0.001
par value; 15,000,000 shares authorized, zero shares issued
or outstanding |
|
|
— |
|
|
|
— |
|
Common stock: $0.001
par value; 500,000,000 shares authorized; 22,667,873 and
21,605,716 shares issued and outstanding at June 30, 2018 and
December 31, 2017, respectively |
|
|
23 |
|
|
|
22 |
|
Additional paid-in
capital |
|
|
156,760 |
|
|
|
155,837 |
|
Accumulated other
comprehensive loss |
|
|
(36 |
) |
|
|
(105 |
) |
Accumulated
deficit |
|
|
(100,717 |
) |
|
|
(73,719 |
) |
Total stockholders'
equity |
|
|
56,030 |
|
|
|
82,035 |
|
Total liabilities and
stockholders' equity |
|
$ |
89,997 |
|
|
$ |
117,007 |
|
|
Aptevo Therapeutics
Inc.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share amounts, unaudited)
|
|
|
For the Three Months Ended
June 30, |
|
|
For the Six Months Ended
June 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
6,826 |
|
|
$ |
3,512 |
|
|
$ |
10,897 |
|
|
$ |
5,626 |
|
Collaborations |
|
|
— |
|
|
|
14 |
|
|
|
— |
|
|
|
42 |
|
Total revenues |
|
|
6,826 |
|
|
|
3,526 |
|
|
|
10,897 |
|
|
|
5,668 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
product sales |
|
|
2,534 |
|
|
|
2,968 |
|
|
|
4,315 |
|
|
|
1,241 |
|
Research
and development |
|
|
9,713 |
|
|
|
6,787 |
|
|
|
17,912 |
|
|
|
12,660 |
|
Selling,
general and administrative |
|
|
7,023 |
|
|
|
8,420 |
|
|
|
14,616 |
|
|
|
18,547 |
|
Loss from
operations |
|
|
(12,444 |
) |
|
|
(14,649 |
) |
|
|
(25,946 |
) |
|
|
(26,780 |
) |
Other
expense from continuing operations |
|
|
(711 |
) |
|
|
(514 |
) |
|
|
(1,118 |
) |
|
|
(920 |
) |
Loss before income
taxes |
|
|
(13,155 |
) |
|
|
(15,163 |
) |
|
|
(27,064 |
) |
|
|
(27,700 |
) |
Benefit from income
taxes |
|
|
— |
|
|
|
996 |
|
|
|
— |
|
|
|
1,819 |
|
Net loss from
continuing operations |
|
|
(13,155 |
) |
|
|
(14,167 |
) |
|
|
(27,064 |
) |
|
|
(25,881 |
) |
Discontinued operations
(Note 2): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
from discontinued operations, before income taxes |
|
|
11 |
|
|
|
3,974 |
|
|
|
65 |
|
|
|
6,566 |
|
Income
tax expense |
|
|
— |
|
|
|
(996 |
) |
|
|
— |
|
|
|
(1,819 |
) |
Income from
discontinued operations |
|
|
11 |
|
|
|
2,978 |
|
|
|
65 |
|
|
|
4,747 |
|
Net loss |
|
$ |
(13,144 |
) |
|
$ |
(11,189 |
) |
|
$ |
(26,999 |
) |
|
$ |
(21,134 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from
continuing operations |
|
$ |
(0.58 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.23 |
) |
Net income from
discontinued operations |
|
$ |
— |
|
|
$ |
0.14 |
|
|
$ |
— |
|
|
$ |
0.22 |
|
Net loss |
|
$ |
(0.58 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.21 |
) |
|
$ |
(1.01 |
) |
Weighted-average shares
used to compute per share calculations |
|
|
22,588,334 |
|
|
|
21,265,599 |
|
|
|
22,308,356 |
|
|
|
21,012,760 |
|
|
About Aptevo Therapeutics
Inc.
Aptevo Therapeutics Inc. is a clinical-stage
biotechnology company focused on novel oncology and hematology
therapeutics to meaningfully improve patients’ lives. Aptevo
has a commercial product, IXINITY® coagulation factor IX
(recombinant), approved and marketed in the United States for the
treatment of Hemophilia B, and a versatile core technology – the
ADAPTIR™ modular protein technology platform capable of generating
highly-differentiated bispecific antibodies with unique mechanisms
of action to treat cancer or autoimmune diseases. Aptevo has
two ADAPTIR antibody candidates currently in clinical development
and a broad pipeline of novel investigational-stage bispecific
antibody candidates focused in immuno-oncology and autoimmune
disease and inflammation. For more information, please visit
www.aptevotherapeutics.com
Safe Harbor Statement
This press release includes forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Any statements, other than statements of
historical fact, including, without limitation, statements
regarding potential milestone payments, Aptevo’s outlook, financial
performance or financial condition, Aptevo’s technology and related
pipeline, collaboration and partnership opportunities, commercial
portfolio, milestones, and any other statements containing the
words “believes,” “expects,” “anticipates,” “intends,” “plans,”
“forecasts,” “estimates,” “will” and similar expressions are
forward-looking statements. These forward-looking statements are
based on Aptevo’s current intentions, beliefs and expectations
regarding future events. Aptevo cannot guarantee that any
forward-looking statement will be accurate. Investors should
realize that if underlying assumptions prove inaccurate or unknown
risks or uncertainties materialize, actual results could differ
materially from Aptevo’s expectations. Investors are, therefore,
cautioned not to place undue reliance on any forward-looking
statement. Any forward-looking statement speaks only as of the date
of this press release, and, except as required by law, Aptevo does
not undertake to update any forward-looking statement to reflect
new information, events or circumstances.
There are a number of important factors that
could cause Aptevo’s actual results to differ materially from those
indicated by such forward-looking statements, including a
deterioration in Aptevo’s business or prospects; challenges in
sales and marketing efforts; adverse developments in research and
development; adverse developments in the U.S. or global capital
markets, credit markets or economies generally; and changes in
regulatory, social and political conditions. Additional risks and
factors that may affect results are set forth in Aptevo’s filings
with the Securities and Exchange Commission, including its most
recent Annual Report on Form 10-K, as filed on March 13, 2018 and
its subsequent reports on Form 10-Q and current reports on Form
8-K. The foregoing sets forth many, but not all, of the factors
that could cause actual results to differ from Aptevo’s
expectations in any forward-looking statement.
Source:
Aptevo Therapeutics Stacey JurchisonSenior Director, Investor
Relations and Corporate Communications206-859-6628
JurchisonS@apvo.com
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