Showcases Differentiating Features of the
ADAPTIR™Protein Therapeutic Platform at Prominent Industry
Conferences
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, 2017.
“I’m extremely proud of our achievements so far
in 2017, particularly when you consider our short history as an
independent company,” commented Marvin L. White, President and
Chief Executive Officer. “With IXINITY now back on track and
beginning to show renewed sales growth, we are increasingly turning
our focus towards the real value-creating opportunity in our
company – our ADAPTIR protein therapeutic platform. There is
discernable momentum building around this asset, as we were
laser-focused during the first half of 2017 on building awareness
in the scientific community around the differentiating features and
benefits of our ADAPTIR platform. This growing awareness
culminated in the execution of an exciting new partnership with
Alligator Bioscience, that will see our companies co-develop a
promising new targeted immunotherapeutic, ALG.APV-527, with a novel
mechanism of action aimed at recruiting the immune system against
various types of solid tumors.”
“As an emerging new class of therapeutics,
bispecific antibodies hold promise for the treatment of a variety
of serious and chronic diseases. With two new bispecific
candidates announced in 2017, APVO436 and ALG.APV-527, and a
growing appreciation in the scientific community for the potential
therapeutic utility of this new class of engineered proteins, we
are excited to continue our progress on this effort and look
forward to providing information around our investigational new
drug (IND) strategy for these candidates later this year,” said Mr.
White.
Second Quarter 2017
Highlights
- Introduced new IXINITY commercial supply to the market in May;
completed successful manufacture of new bulk drug substance batches
of IXINITY confirming resolution of the bulk drug substance
manufacturing challenge.
- Presented new clinical data evaluating the safety and efficacy
of IXINITY in children with Hemophilia B, showing that IXINITY
appears to be safe and well tolerated in this subject
population.
- Presented data on the ADAPTIR protein therapeutic platform at
two prominent industry conferences, the Americas Antibody Congress
2017 and the 2017 Next Generation Protein Therapeutics Summit,
highlighting the activity, stability, extended half-life and
superior manufacturability of Aptevo’s ADAPTIR bispecific antibody
candidates.
- Selected a new ADAPTIR bispecific candidate, APVO436, and
presented comprehensive preclinical data at the American
Association for Cancer Research 2017 annual meeting demonstrating
potent in vitro and in vivo immune activation and an extended
half-life of 12.5 days in rodents for APVO436.
- Announced a collaboration agreement with Alligator Bioscience
to jointly develop and advance a lead bispecific antibody
candidate, ALG.APV-527, with a novel mechanism of action targeting
4-1BB and an undisclosed tumor antigen, demonstrating the
flexibility of Aptevo’s ADAPTIR protein therapeutic platform.
Second Quarter 2017 Financial
Results
Cash Position: Aptevo had
cash, cash equivalents, and short-term investments as of June 30,
2017 totaling $48.6 million.
Product Sales Revenue:
Total product sales revenue was $10.8 million for the three months
ended June 30, 2017, compared to $10.2 million for the same period
in 2016. The increase in product sales revenue was primarily
due to increased sales of IXINITY as new supply of IXINITY was
reintroduced during the current period, offset by reduced sales of
WinRho.
Cost of Product Sales:
Cost of product sales decreased by $0.6 million, or 10%, to $5.9
million for the three months ended June 30, 2017 from $6.5 million
for the three months ended June 30, 2016. This decrease was due to
lower sales costs associated with WinRho, as the product sales also
decreased, offset by increased costs associated with IXINITY and
HepaGam.
Research and Development
Expenses: Research and development expenses
decreased by $0.8 million, or 11%, to $6.8 million for the three
months ended June 30, 2017, from $7.6 million for the corresponding
period in 2016. Aptevo’s research and development expenses
for the three months ended June 30, 2017 are summarized in the
table below.
|
|
|
|
|
|
For the Three Months
EndedJune 30, |
|
|
|
|
|
(in thousands) |
|
|
|
|
|
2017 |
|
2016 |
|
|
Change |
|
ADAPTIR
related programs |
|
|
|
|
|
$ |
2,276 |
|
$ |
3,277 |
|
|
$ |
(1,001 |
) |
APVO436 |
|
|
|
|
|
|
1,791 |
|
|
30 |
|
|
|
1,761 |
|
MOR209/ES414 |
|
|
|
|
|
|
795 |
|
|
825 |
|
|
|
(30 |
) |
IXINITY |
|
|
|
|
|
|
619 |
|
|
1,140 |
|
|
|
(521 |
) |
otlertuzumab |
|
|
|
|
|
|
413 |
|
|
830 |
|
|
|
(417 |
) |
ROR1 |
|
|
|
|
|
|
867 |
|
|
1,434 |
|
|
|
(567 |
) |
Other |
|
|
|
|
|
|
27 |
|
|
100 |
|
|
|
(73 |
) |
Total |
|
|
|
|
|
$ |
6,788 |
|
$ |
7,636 |
|
|
$ |
(848 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, General and Administrative
Expenses: Selling, general and administrative
expenses for the three months ended June 30, 2017 were $8.8
million, compared to $8.9 million for the same period in 2016, and
decreased primarily as a result of reduced personnel costs.
Net Loss: Aptevo’s net
loss for the three months ended June 30, 2017 was $11.2 million or
($0.53) per share, compared to $12.8 million or ($0.63) per share
for the corresponding period in 2016.
Financial Statements Follow
Aptevo Therapeutics
Inc. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(in thousands, except share and per share
amounts, unaudited) |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
June 30, 2017 |
|
|
December 31,2016 |
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
22,269 |
|
|
$ |
9,676 |
|
Restricted cash |
|
|
400 |
|
|
|
400 |
|
Short-term investments |
|
|
25,958 |
|
|
|
44,849 |
|
Accounts
receivable, net |
|
|
4,715 |
|
|
|
4,284 |
|
Inventories |
|
|
7,984 |
|
|
|
6,639 |
|
Prepaid
expenses and other current assets |
|
|
5,867 |
|
|
|
5,566 |
|
Total
current assets |
|
|
67,193 |
|
|
|
71,414 |
|
Property
and equipment, net |
|
|
6,205 |
|
|
|
5,910 |
|
Intangible assets, net |
|
|
13,493 |
|
|
|
14,534 |
|
Total
assets |
|
$ |
86,891 |
|
|
$ |
91,858 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and other accrued liabilities |
|
$ |
5,349 |
|
|
$ |
11,489 |
|
Accrued
compensation |
|
|
2,944 |
|
|
|
4,009 |
|
Sales
rebates and discounts |
|
|
2,146 |
|
|
|
3,235 |
|
Deferred
revenue, current portion |
|
|
1,444 |
|
|
|
811 |
|
Total
current liabilities |
|
|
11,883 |
|
|
|
19,544 |
|
|
|
|
|
|
|
|
|
|
Deferred
revenue, net of current portion |
|
|
2,796 |
|
|
|
2,896 |
|
Long-term
debt, net |
|
|
18,745 |
|
|
|
18,383 |
|
Other
liabilities |
|
|
2,047 |
|
|
|
469 |
|
Total
liabilities |
|
|
35,471 |
|
|
|
41,292 |
|
|
|
|
|
|
|
|
|
|
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; 21,309,744 and
20,271,737 shares issued and outstanding at June 30, 2017 and
December 31, 2016, respectively |
|
|
21 |
|
|
|
20 |
|
Additional paid-in
capital |
|
|
153,239 |
|
|
|
151,271 |
|
Accumulated other
comprehensive loss |
|
|
(14 |
) |
|
|
(33 |
) |
Contribution receivable
from former parent |
|
|
— |
|
|
|
(20,000 |
) |
Accumulated
deficit |
|
|
(101,826 |
) |
|
|
(80,692 |
) |
Total stockholders'
equity |
|
|
51,420 |
|
|
|
50,566 |
|
Total liabilities and
stockholders' equity |
|
$ |
86,891 |
|
|
$ |
91,858 |
|
|
Aptevo Therapeutics Inc. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(in thousands, except share and per share
amounts, unaudited) |
|
|
|
For the Three Months
EndedJune 30, |
|
|
|
2017 |
|
|
2016 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product
sales |
|
$ |
10,750 |
|
|
$ |
10,159 |
|
Collaborations |
|
|
14 |
|
|
|
34 |
|
Total revenues |
|
|
10,764 |
|
|
|
10,193 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
Cost of
product sales |
|
|
5,897 |
|
|
|
6,544 |
|
Research
and development |
|
|
6,788 |
|
|
|
7,636 |
|
Selling,
general and administrative |
|
|
8,755 |
|
|
|
8,858 |
|
Loss from
operations |
|
|
(10,676 |
) |
|
|
(12,845 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Other
income (expense), net |
|
|
(513 |
) |
|
|
(4 |
) |
Total other income
(expense), net |
|
|
(513 |
) |
|
|
(4 |
) |
Loss before income
taxes |
|
|
(11,189 |
) |
|
|
(12,849 |
) |
Benefit from income
taxes |
|
|
— |
|
|
|
(11 |
) |
Net loss |
|
|
(11,189 |
) |
|
|
(12,838 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
|
$ |
(0.53 |
) |
|
$ |
(0.63 |
) |
Shares used to compute
net loss per share - basic and diluted |
|
|
21,265,599 |
|
|
|
20,229,849 |
|
|
|
|
|
|
|
|
|
|
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a biotechnology
company focused on novel oncology and hematology therapeutics to
meaningfully improve patients’ lives. Aptevo’s core technology is
the ADAPTIR™ (modular protein technology) platform. Aptevo has four
commercial products in the areas of hematology and infectious
diseases, as well as various investigational stage product
candidates in immuno-oncology.
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 Aptevo’s outlook, financial performance or financial
condition, our technology and related pipeline, collaboration and
partnership opportunities, commercial portfolio, Aptevo’s future
growth rates, Aptevo’s ability to timely manufacture its products,
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 our actual results to differ materially from those
indicated by such forward-looking statements, including possible
negative effects on our business operations, assets or financial
results as a result of the separation; a deterioration in our
business or prospects; the ability of our contractors and suppliers
to supply product and materials; our ability and the ability
of our contractors and suppliers to maintain compliance with cGMP
and other regulatory obligations; the results of regulatory
inspections; adverse developments in our customer-base or markets
and our ability to retain patients; 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 our filings with the Securities and Exchange
Commission, including Aptevo’s most recent Annual Report on Form
10-K, as filed on March 15, 2017, and our 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 our expectations in any forward-looking
statement.
Aptevo Therapeutics
Stacey Jurchison
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com
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