Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global
biopharmaceutical company pioneering targeted C3 therapies, today
announced its fourth quarter and full year 2019 financial results
and business highlights.
“We are thrilled with the progress we made over the past year to
advance our pipeline and validate our unique C3-targeted approach.
In January, we announced top-line results from the Phase 3 PEGASUS
trial, which met its primary endpoint and demonstrated that
pegcetacoplan was superior to eculizumab with a statistically
significant improvement in hemoglobin levels. We believe that
pegcetacoplan has the potential to elevate the standard of care for
people with PNH, and these results also strengthened our confidence
in the platform potential of pegcetacoplan to treat a wide array of
serious, complement-driven diseases,” said Cedric Francois, M.D.,
Ph.D., co-founder and chief executive officer of Apellis.
“We plan to build on this momentum in 2020 by completing
enrollment in three separate Phase 3 trials of pegcetacoplan
including two in geographic atrophy, a leading cause of blindness
that affects approximately five million people worldwide and has no
approved treatments. We also plan to meet with regulators in the US
and EU in the first half of this year to discuss next steps for
regulatory submissions of pegcetacoplan in PNH,” Dr. Francois
added. “We are committed to delivering life-changing therapies for
people with serious diseases, and 2020 will be focused on executing
to make this a reality.”
Business Highlights and Upcoming
Milestones:
Subcutaneous Pegcetacoplan (APL-2)
- In January 2020, Apellis announced positive results from the
Phase 3 head-to-head PEGASUS study evaluating pegcetacoplan
compared to eculizumab in 80 adults with PNH. Top-line data showed
that pegcetacoplan met the study’s primary efficacy endpoint,
demonstrating superiority to eculizumab with a statistically
significant improvement in adjusted means of 3.8 g/dL of hemoglobin
at week 16 (p<0.0001). The safety profile of pegcetacoplan was
comparable to eculizumab in the study. Apellis plans to present
detailed 16-week results from the study at a future scientific
meeting, and the company also expects to report 48-week top-line
results from the trial in the second half of 2020.
- Apellis expects to complete enrollment in the Phase 3 PRINCE
trial evaluating pegcetacoplan in treatment-naïve PNH patients in
the first half of 2020 and announce top-line data from the study in
early 2021.
- Apellis plans to disclose plans and timing for further clinical
development of pegcetacoplan for patients with cold agglutinin
disease (CAD) in the first half of 2020. In June 2019, positive
interim data for pegcetacoplan in patients with CAD were presented
from the Phase 2 PLAUDIT trial at the 24th Annual Congress of
the European Hematology Association (EHA).
- In November 2019, Apellis announced positive preliminary
results in the C3 glomerulopathy (C3G) cohort of the Phase 2
DISCOVERY study. The results, which showed a reduction in mean
proteinuria of nearly 50% at study day 84, were presented at the
American Society of Nephrology (ASN) Kidney Week 2019 in Washington
D.C. The company expects to disclose plans and timing for further
clinical development of pegcetacoplan for patients with C3G in the
first half of 2020.
Intravitreal Pegcetacoplan
- Apellis expects that its two Phase 3 trials for pegcetacoplan
in patients with geographic atrophy (GA), DERBY and OAKS, will be
fully enrolled in the first half of 2020 and that the company will
announce top-line results from these trials in mid-2021.
Intravenous C3 Inhibition
- Apellis is developing compounds targeting C3 for intravenous
administration. In particular, Apellis continues to develop APL-9
for the prevention of complement immune system activation
coincident with adeno-associated virus vector administration for
gene therapies.
Corporate & Other Highlights
- In January 2020, Apellis announced the closing of its public
offering of 10,925,000 shares of common stock at the public
offering price of $37.00 per share, including 1,425,000 shares
issued upon the exercise in full by the underwriters of their
option to purchase additional shares. The gross proceeds from the
offering, before deducting underwriting discounts, commissions, and
expenses were approximately $404.2 million.
- In September 2019, Apellis announced the closing of its
offering of 3.500% convertible senior notes due 2026. The notes are
convertible into shares of Apellis common stock at an initial
conversion rate of 25.3405 shares per $1,000 principal amount of
notes. Upon conversion of the notes, Apellis may pay or deliver, as
the case may be, cash, shares of common stock, or a combination of
cash and shares of common stock, at Apellis’ election. The gross
proceeds from this offering, before discounts, commissions, and
expenses were approximately $220 million.
- In March 2019, Apellis announced the closing of its public
offering of 6,900,000 shares of common stock, at a public offering
price of $17.00 per share, including 900,000 shares issued upon the
exercise in full by the underwriters of their option to purchase
additional shares. The gross proceeds from the offering, before
deducting underwriting discounts and commissions and expenses
payable by Apellis, were approximately $117.3 million.
- In February 2019, Apellis announced a collaboration with SFJ
Pharmaceuticals® to support the development of pegcetacoplan in
hematologic indications. Under the agreement, Apellis has received
$140.0 million in upfront and near-term milestone payments,
including the last $20.0 million in January 2020.
Fourth Quarter and Full Year 2019 Financial
Results:
As of December 31, 2019, Apellis had $352.0 million in cash and
cash equivalents, compared to $176.3 million as of December 31,
2018. In addition, in January 2020, the company raised
approximately $381.4 million in net proceeds in a public offering
and received the final $20.0 million milestone payment from SFJ
Pharmaceuticals.
Apellis reported a net loss of $113.2 million for the fourth
quarter of 2019, compared to a net loss of $36.5 million for the
fourth quarter of 2018. For the full year ending December 31, 2019,
Apellis reported a net loss of $304.7 million, compared to a net
loss of $127.5 million for the full year ending December 31,
2018.
Research and development expenses were $78.5 million in the
fourth quarter of 2019, compared to $30.8 million for the same
period in 2018. For the full year ending December 31, 2019,
research and development expenses were $221.0 million, compared to
$105.3 million for the full year ending December 31, 2018. The
increase in R&D expenses for full year 2019 was primarily
attributable to an increase of $41.1 million in clinical trial
costs associated with the preparation for and commencement of our
Phase 3 clinical trials, an increase of $43.8 million in
manufacturing expenses in connection with the supply of
pegcetacoplan for our Phase 3 clinical trials, an increase of $23.5
million in compensation and related personnel costs primarily due
to the hiring of additional personnel in 2019, an increase of $6.5
million related to preclinical study expenses, and an increase of
$2.2 million in research and development supporting activities and
offset by a decrease of $1.4 million in device development
expenses. We expect our research and development expenses to
continue to increase as the number of patients in our trials
increases and the number of ongoing trials increases.
General and administrative expenses were $27.5 million in the
fourth quarter of 2019, compared to $6.4 million for the same
period in 2018. For the full year ending December 31, 2019, general
and administrative expenses were $67.0 million, compared to $22.6
million for the full year ending December 31, 2018. The increase in
general and administrative expenses for full year 2019 was
primarily attributable to an increase in employee-related costs of
$21.0 million due to the hiring of additional personnel, an
increase in professional and consulting fees of $20.2 million, an
increase in office, travel and related costs of $2.1 million, an
increase of $1.5 million in information technology expenses, and an
increase in insurance costs of $0.6 million. These increases were
offset by a decrease in license agreement costs of $1.0 million
from the payment of certain milestones met in 2018. The increased
employee-related costs of $21.0 million consisted of $12.7 million
related to an increase in salaries and benefits primarily due to
the hiring of additional members of our management team, $6.3
million related to stock option expense associated with the grants
of stock options to employees and $2.0 million in recruitment
expense. The increased professional and consulting fees of $20.2
million primarily consisted of an increase in consulting fees of
$16.7 million, an increase of $2.0 million in legal fees, an
increase in communication and public relations fees of $0.9
million, an increase of $0.5 million in accounting fees, and an
increase of $0.1 million in public company costs.
About Pegcetacoplan (APL-2)Pegcetacoplan is an
investigational, targeted C3 inhibitor designed to regulate
excessive complement activation, which can lead to the onset and
progression of many serious diseases. Pegcetacoplan is a synthetic
cyclic peptide conjugated to a polyethylene glycol polymer that
binds specifically to C3 and C3b. Apellis is evaluating
pegcetacoplan in several clinical studies including paroxysmal
nocturnal hemoglobinuria (PNH), geographic atrophy (GA), and C3
glomerulopathy (C3G). Pegcetacoplan was granted Fast Track
designation by the U.S. Food and Drug Administration (FDA) for the
treatment of PNH and the treatment of GA. For additional
information regarding our clinical trials, visit
www.apellis.com/clinical-trials.html.
About APL-9APL-9 is an investigational,
targeted C3 inhibitor that leverages the same mechanism of action
as Apellis’ lead compound, pegcetacoplan, but has a lower molecular
weight and shorter half-life. APL-9 is designed to be intravenously
administered for acute use whereas pegcetacoplan is designed for
chronic subcutaneous or intravitreal administration.
About ApellisApellis Pharmaceuticals,
Inc. is a global biopharmaceutical company that is committed
to leveraging courageous science, creativity, and compassion to
deliver life-changing therapies. By pioneering targeted C3
therapies, we aim to develop best-in-class and first-in-class
therapies for a broad range of debilitating diseases that are
driven by uncontrolled or excessive activation of the complement
cascade, including those within hematology, ophthalmology, and
nephrology. For more information, please visit
http://apellis.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans
and prospects, as well as any other statements regarding matters
that are not historical facts, may constitute “forward-looking
statements” within the meaning of The Private Securities Litigation
Reform Act of 1995. These statements include, but are not limited
to, statements relating to the implications of preliminary clinical
data. The words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” “would” and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results may differ materially from
those indicated by such forward-looking statements as a result of
various important factors, including: whether the company’s
clinical trials will be fully enrolled and completed when
anticipated; whether preliminary or interim results from a clinical
trial will be predictive of the final results of the trial; whether
results obtained in preclinical studies and clinical trials will be
indicative of results that will be generated in future clinical
trials; whether pegcetacoplan will successfully advance through the
clinical trial process on a timely basis, or at all; whether the
results of the company’s clinical trials will warrant regulatory
submissions and whether pegcetacoplan will receive approval from
the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD,
C3G or any other indication when expected or at all; whether, if
Apellis’ products receive approval, they will be successfully
distributed and marketed; and other factors discussed in the “Risk
Factors” section of Apellis’ Annual Report on Form 10-K filed with
the Securities and Exchange Commission on February 27, 2020 and the
risks described in other filings that Apellis may make with the
Securities and Exchange Commission. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Apellis specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Investor Contact: Sam Martin / Maghan
Meyers Argot Partners
sam@argotpartners.com / maghan@argotpartners.com
212.600.1902
Media Contact: Tracy Vineis media@apellis.com
617.420.4839
APELLIS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
|
|
|
December 31, |
|
|
2018 |
|
2019 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
176,267,666 |
|
|
$ |
351,985,085 |
|
Prepaid assets |
|
24,333,851 |
|
|
19,802,008 |
|
Other current assets |
|
1,837,704 |
|
|
1,307,591 |
|
Total current assets |
|
202,439,221 |
|
|
373,094,684 |
|
Non-current Assets: |
|
|
|
|
|
|
Right-of-use assets |
|
— |
|
|
14,110,209 |
|
Property and equipment, net |
|
977,918 |
|
|
1,654,999 |
|
Other assets |
|
116,420 |
|
|
385,088 |
|
Total assets |
|
$ |
203,533,559 |
|
|
$ |
389,244,980 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
10,254,938 |
|
|
$ |
8,360,527 |
|
Accrued expenses |
|
5,103,002 |
|
|
54,782,951 |
|
Current portion of long-term-debt |
|
1,666,667 |
|
|
- |
|
Current portion of operating lease liabilities |
|
|
|
|
2,609,341 |
|
Total current liabilities |
|
17,024,607 |
|
|
65,752,819 |
|
Long-term liabilities: |
|
|
|
|
|
|
Convertible Senior Notes |
|
— |
|
|
142,566,851 |
|
Development derivative liability |
|
— |
|
|
134,839,000 |
|
Term loan facility |
|
18,722,321 |
|
|
- |
|
Promissory note |
|
6,655,193 |
|
|
- |
|
Operating lease liabilities |
|
— |
|
|
11,856,634 |
|
Other liabilities |
|
158,783 |
|
|
- |
|
Total liabilities |
|
42,560,904 |
|
|
355,015,304 |
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized
and zero shares issued and outstanding at December 31, 2018
and 2019 |
|
— |
|
|
— |
|
Common stock, $0.0001 par value; 200,000,000 shares authorized and
at December 31, 2018 and 2019; 56,279,307 and 63,938,003
shares issued and outstanding at December 31, 2018 and
2019, respectively. |
|
5,628 |
|
|
6,393 |
|
Additional Paid-in capital |
|
437,855,681 |
|
|
615,849,518 |
|
Accumulated other comprehensive loss |
|
(122,807 |
) |
|
(153,775 |
) |
Accumulated deficit |
|
(276,765,847 |
) |
|
(581,472,460 |
) |
Total stockholders' equity |
|
160,972,655 |
|
|
34,229,676 |
|
Total liabilities and stockholders' equity |
|
$ |
203,533,559 |
|
|
$ |
389,244,980 |
|
|
|
|
|
|
|
|
APELLIS PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
|
|
Three Months Ended December 31, |
|
Year Ended Deccember 31, |
|
2018 |
|
2019 |
|
2018 |
|
2019 |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
30,805,611 |
|
|
$ |
78,471,427 |
|
|
$ |
105,285,576 |
|
|
$ |
220,968,770 |
|
General and administrative |
6,390,981 |
|
|
27,468,856 |
|
|
22,639,184 |
|
|
67,046,483 |
|
Operating loss |
(37,196,592 |
) |
|
(105,940,283 |
) |
|
(127,924,760 |
) |
|
(288,015,253 |
) |
Loss on extinguishment of
debt |
— |
|
|
— |
|
|
— |
|
|
(1,501,215 |
) |
Loss from remeasurement of
development derivative liability |
— |
|
|
(4,736,000 |
) |
|
— |
|
|
(14,839,000 |
) |
Interest expense |
(624,365 |
) |
|
(3,930,232 |
) |
|
(2,512,956 |
) |
|
(5,284,610 |
) |
Interest income |
873,355 |
|
|
1,478,465 |
|
|
2,960,771 |
|
|
5,108,779 |
|
Other income (expense), net |
488,127 |
|
|
(89,373 |
) |
|
(25,249 |
) |
|
(175,314 |
) |
Net loss |
$ |
(36,459,475 |
) |
|
$ |
(113,217,423 |
) |
|
(127,502,194 |
) |
|
(304,706,613 |
) |
Other comprehensive gain (loss): |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency gain (loss) |
(462,748 |
) |
|
51,474 |
|
|
(122,807 |
) |
|
(30,968 |
) |
Total other comprehensive gain (loss) |
(462,748 |
) |
|
51,474 |
|
|
(122,807 |
) |
|
(30,968 |
) |
Comprehensive loss, net of tax |
$ |
(36,922,223 |
) |
|
$ |
(113,165,949 |
) |
|
$ |
(127,625,001 |
) |
|
$ |
(304,737,581 |
) |
Net loss per common share, basic and diluted |
$ |
(0.65 |
) |
|
$ |
(1.77 |
) |
|
$ |
(2.34 |
) |
|
$ |
(4.90 |
) |
Weighted-average number of common shares used in net loss
per common share, basic and diluted |
56,201,299 |
|
|
63,901,355 |
|
|
54,396,483 |
|
|
62,228,601 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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