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 third quarter ended September 30, 2019.
“Net revenue for IXINITY® in the third quarter
of 2019 reached a record level at $9 million, representing an
increase of approximately 55% year-over-year and 22%
quarter-over-quarter,” said Marvin L. White, President and Chief
Executive Officer. “Our commercial organization has done a
fantastic job leveraging the launch of our new 3000 IU assay and
continuing to grow awareness and market share. Based on unit
volume, the third quarter of 2019 was our best quarter ever in
terms of new patient conversions. In addition to the launch
of the new larger presentation we will also be commencing a
pediatric study of IXINITY with the goal of obtaining a pediatric
label expansion for IXINITY in the United States. We’re excited
about these latest growth initiatives and continue to be very
pleased with the growth trend for IXINITY and the momentum we are
building around this product.”
“Our lead ADAPTIR™ clinical candidate, APVO436,
is an optimized bispecific antibody that features improvements over
earlier ADAPTIR candidates, including an extended half-life,
enhanced potency, desirable manufacturing properties and the
potential for reduced immunogenicity. As we reported in our
recent conference call, APVO436 is currently being evaluated in a
Phase 1/1b clinical study in patients with acute myeloid leukemia
and high-grade myelodysplastic syndrome and continues to make solid
progress,” continued Mr. White. “This is a particularly
important phase of the development program for APVO436 as the
preclinical and pharmacokinetic models suggest that in the upcoming
dose cohorts we may achieve dose levels of APVO436 with potential
clinical effect. We expect to report ongoing progress from
the APVO436 Phase 1/1b study over the next several quarters as more
clinical data emerge.”
Third Quarter 2019
Highlights
- Reported record quarterly IXINITY net revenue of $9 million;
achieved a 55% increase in year-over-year IXINITY net revenue in
the third quarter of 2019 through continued expansion of the
patient base for IXINITY
- Continued to expand awareness of IXINITY following the launch
of a 3000 IU assay late in the second quarter of 2019, which
provides enhanced convenience for patients
- Commenced enrolling clinical sites in preparation to begin
dosing in an upcoming clinical study of IXINITY in pediatric
patients (under 12 years of age) for potential label expansion of
IXINITY in the United States in a pediatric setting; patients under
the age of 12 years currently make up approximately 1/3 of the
hemophilia B U.S. treatment population
- Continued enrollment in a dose escalation Phase 1/1b open-label
clinical study of APVO436 in patients with acute myeloid leukemia
and high-grade myelodysplastic syndrome; dosing in Cohort 4 is
currently underway; Aptevo anticipates sharing additional data from
the study over the next several months
- Presented preclinical data at the 10th Annual World Bispecific
Summit on a new ADAPTIR bispecific antibody candidate, APVO603, a
dual agonist bispecific antibody employing a novel mechanism of
action to simultaneously target 4-1BB (CD137) and OX40 (CD134),
both members of the TNF-receptor family; dual targeting of 4-1BB
and OX40 provides synergistic co-stimulation of T cells with the
potential to amplify the cytotoxic function of activated T cells
and NK cells, potentially leading to more robust anti-tumor
responses
- Discontinued development of APVO210 in October 2019, the
Company’s investigational targeted cytokine bispecific antibody
candidate; the decision to discontinue development was based on
data from a multiple ascending dose study of APVO210 in healthy
volunteers suggesting that it would not meet the desired target
product profile for future commercialization
- Received an accelerated performance-based $4.3 million
milestone payment from Saol Therapeutics, part of a purchase
agreement between Aptevo and Saol, originally executed in August
2017 and amended in August 2019, under which Saol acquired three
hyperimmune products previously marketed by Aptevo: WinRho SDF,
HepaGam B, and VARIZIG
- Implemented an expense reduction plan in October 2019
- Along with Aptevo’s co-development partner, Alligator
Bioscience, the companies made a joint decision to delay submission
of the clinical trial authorization for ALG-APV.527 previously
planned for the fourth quarter of 2019; the companies are focusing
efforts on partnering ALG.APV-527 prior to Phase 1 clinical
development and have initiated discussions with potential
partners
Third Quarter 2019 Financial
Results
Cash Position: Aptevo had
cash, cash equivalents, and marketable securities as of September
30, 2019 totaling $25.2 million, including $7.5 million in
restricted cash.
IXINITY Revenue: Product
sales of IXINITY increased by $3.2 million, or 55%, to $9.0 million
for the three months ended September 30, 2019, compared to $5.8
million for the same period in 2018. The increase in IXINITY sales
in the quarter was primarily related to the continuing expansion of
the Hemophilia B patient base and the launch of the 3,000 IU assay
size in the second quarter of 2019, which resulted in increased
IU’s sold during the period, and price increases in 2019.
Cost of Product Sales:
Cost of product sales for the three months ended September 30, 2019
increased by $1.5 million, or 62% to $4.0 million compared to $2.4
million for the three months ended September 30, 2018, primarily
driven by increased IU’s sold during the three months ended
September 30, 2019 compared to 2018. This increase was offset by
credits received from Aptevo’s bulk drug supplier of $0.2 million
for materials previously purchased.
Research and Development
Expenses: Research and development expenses
increased by $0.6 million, to $9.1 million for the three months
ended September 30, 2019, compared to $8.6 million for the
corresponding period in 2018. This was due to increased
spending for Aptevo’s IXINITY pediatric clinical program as well as
its preclinical, general research and discovery programs, offset by
lower spending on other clinical programs, including APVO210, which
was discontinued in October 2019.
Selling, General and Administrative
Expenses: Selling, general and administrative
expenses decreased by $0.5 million, or approximately 7%, to $6.5
million for the three months ended September 30, 2019, compared to
$6.9 million for the same period in 2018. The decrease in
these expenses in the third quarter of 2019 was primarily due to
reduced personnel and professional services costs.
Net Loss: Aptevo’s net
loss for the three months ended September 30, 2019 was ($6.9)
million or ($0.16) per share, compared to ($12.6) million or
($0.55) per share for the three months ended September 30,
2018.
Financial Statements Follow
Aptevo Therapeutics
Inc.CONDENSED CONSOLIDATED BALANCE
SHEETS(in thousands, except share and per share
amounts, unaudited)
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
17,683 |
|
|
$ |
30,635 |
|
Accounts receivable, net |
|
|
7,918 |
|
|
|
5,220 |
|
Inventories |
|
|
7,482 |
|
|
|
1,785 |
|
Prepaid expenses |
|
|
2,215 |
|
|
|
6,907 |
|
Other current assets |
|
|
1,491 |
|
|
|
4,142 |
|
Total current assets |
|
|
36,789 |
|
|
|
48,689 |
|
Restricted cash |
|
|
7,498 |
|
|
|
7,448 |
|
Property and equipment, net |
|
|
4,271 |
|
|
|
5,202 |
|
Intangible assets, net |
|
|
4,628 |
|
|
|
5,250 |
|
Operating lease right-of-use asset |
|
|
3,981 |
|
|
|
— |
|
Other assets |
|
|
3,389 |
|
|
|
905 |
|
Total assets |
|
$ |
60,556 |
|
|
$ |
67,494 |
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
12,073 |
|
|
$ |
11,671 |
|
Accrued compensation |
|
|
3,483 |
|
|
|
3,898 |
|
Sales rebates and discounts payable |
|
|
868 |
|
|
|
1,245 |
|
Loan payable, net |
|
|
19,707 |
|
|
|
— |
|
Other short-term liabilities |
|
|
1,121 |
|
|
|
796 |
|
Total current liabilities |
|
|
37,252 |
|
|
|
17,610 |
|
Long-term debt, net |
|
|
— |
|
|
|
19,278 |
|
Operating lease liability, net of current portion |
|
|
3,547 |
|
|
|
— |
|
Other liabilities |
|
|
12 |
|
|
|
200 |
|
Total liabilities |
|
|
40,811 |
|
|
|
37,088 |
|
|
|
|
|
|
|
|
|
|
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; 45,279,244 and 22,808,416
shares issued and outstanding at September 30, 2019 and
December 31, 2018, respectively |
|
|
45 |
|
|
|
23 |
|
Additional paid-in capital |
|
|
179,382 |
|
|
|
157,791 |
|
Accumulated deficit |
|
|
(159,682 |
) |
|
|
(127,408 |
) |
Total stockholders' equity |
|
|
19,745 |
|
|
|
30,406 |
|
Total liabilities and
stockholders' equity |
|
$ |
60,556 |
|
|
$ |
67,494 |
|
|
|
|
|
|
|
|
|
|
Aptevo Therapeutics
Inc.CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(in thousands, except share and per
share amounts, unaudited)
|
|
For the Three Months Ended September 30, |
|
|
For the Nine Months Ended September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
9,011 |
|
|
$ |
5,824 |
|
|
$ |
23,393 |
|
|
$ |
16,721 |
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales |
|
|
3,959 |
|
|
|
2,437 |
|
|
|
13,791 |
|
|
|
6,752 |
|
Research and development |
|
|
9,125 |
|
|
|
8,574 |
|
|
|
24,143 |
|
|
|
26,486 |
|
Selling, general and administrative |
|
|
6,476 |
|
|
|
6,940 |
|
|
|
20,344 |
|
|
|
21,556 |
|
Loss from operations |
|
|
(10,549 |
) |
|
|
(12,127 |
) |
|
|
(34,885 |
) |
|
|
(38,073 |
) |
Other expense from continuing operations |
|
|
(625 |
) |
|
|
(435 |
) |
|
|
(1,639 |
) |
|
|
(1,488 |
) |
Loss before income tax |
|
|
(11,174 |
) |
|
|
(12,562 |
) |
|
|
(36,524 |
) |
|
|
(39,561 |
) |
Benefit from income tax |
|
|
999 |
|
|
|
— |
|
|
|
999 |
|
|
|
— |
|
Net loss from continuing
operations |
|
|
(10,175 |
) |
|
|
(12,562 |
) |
|
|
(35,525 |
) |
|
|
(39,561 |
) |
Discontinued operations (Note
11): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from discontinued operations, before income taxes |
|
|
4,250 |
|
|
|
— |
|
|
|
4,250 |
|
|
|
— |
|
Income tax expense |
|
|
(999 |
) |
|
|
— |
|
|
|
(999 |
) |
|
|
— |
|
Income from discontinued
operations |
|
|
3,251 |
|
|
|
— |
|
|
|
3,251 |
|
|
|
— |
|
Net loss |
|
$ |
(6,924 |
) |
|
$ |
(12,562 |
) |
|
$ |
(32,274 |
) |
|
$ |
(39,561 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share
amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from continuing
operations |
|
$ |
(0.23 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.90 |
) |
|
$ |
(1.76 |
) |
Income from discontinued
operations |
|
$ |
0.07 |
|
|
$ |
— |
|
|
$ |
0.08 |
|
|
$ |
— |
|
Net loss per basic share |
|
$ |
(0.16 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.82 |
) |
|
$ |
(1.76 |
) |
Weighted-average shares used to
compute per share calculations |
|
|
45,169,864 |
|
|
|
22,672,721 |
|
|
|
39,341,974 |
|
|
|
22,431,146 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
About Aptevo Therapeutics
Inc.
Aptevo Therapeutics Inc. is a clinical-stage
biotechnology company focused on developing 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 for the treatment of different types of
cancer. 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; 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 18, 2019 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 Jurchison Senior Director, Investor Relations and Corporate
Communications 206-859-6628 JurchisonS@apvo.com
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