- Total product and royalty revenues of $593 million (+16% vs Q2
2019) for the quarter ended June 30, 2020; Jakafi® (ruxolitinib)
revenues of $474 million in Q2 2020 (+16% vs Q2 2019)
- Monjuvi® (tafasitamab-cxix; collaboration with MorphoSys)
approved by U.S. FDA; launch preparations already underway
- TabrectaTM (capmatinib; licensed to Novartis) approved by U.S.
FDA and Japanese MHLW; Incyte eligible for milestones and royalties
on global net sales
- Primary and both key secondary endpoints met in Phase 3 REACH3
trial of Jakafi in patients with steroid-refractory chronic
graft-versus-host disease
Conference Call and Webcast Scheduled Today at
8:00 a.m. EDT
Incyte (Nasdaq: INCY) today reports 2020 second quarter
financial results, and provides a status update on the Company’s
development portfolio.
“We continue to execute successfully across all aspects of our
business,” stated Hervé Hoppenot, Chief Executive Officer, Incyte.
“Demand for Jakafi® (ruxolitinib) is robust and the recent approval
of Pemazyre® (pemigatinib), as well as those of Monjuvi®
(tafasitamab-cxix) with MorphoSys and TabrectaTM (capmatinib) with
Novartis, add to our momentum. In addition, clinical updates from
the tafasitamab and LIMBER programs at the recent EHA congress, the
successful outcome of REACH3, and our plan to submit an NDA seeking
approval for ruxolitinib cream at the end of this year, further
illustrate the opportunities within our portfolio to drive
additional diversification and growth.”
Portfolio Update
LIMBER – key highlights
Positive proof-of-concept data for parsaclisib in combination
with ruxolitinib in myelofibrosis (MF) patients with an inadequate
response to ruxolitinib monotherapy were presented at the virtual
25th Congress of the European Hematology Association (EHA). Incyte
plans to initiate pivotal trials of the combination of ruxolitinib
and parsaclisib as both first-line therapy for MF patients and in
MF patients with an inadequate response to ruxolitinib
monotherapy.
Monotherapy treatment cohorts in the trials of INCB57643 (BET)
and INCB00928 (ALK2) in patients with myelofibrosis are being
opened for recruitment, and these are expected to be followed by
the initiation of ruxolitinib combination trials with both agents.
Further development of the combination of INCB53914 (PIM) plus
ruxolitinib has been discontinued.
Indication and status
Once-a-day ruxolitinib
(JAK1/JAK2)
Myelofibrosis and polycythemia vera:
clinical pharmacology studies
ruxolitinib + parsaclisib (JAK1/JAK2 +
PI3Kδ)
Refractory myelofibrosis: Phase 3 in
preparation
First-line myelofibrosis: Phase 3 in
preparation
ruxolitinib + INCB57643 (JAK1/JAK2 +
BET)
Refractory myelofibrosis: Phase 2 in
preparation
ruxolitinib + INCB00928 (JAK1/JAK2 +
ALK2)
Myelofibrosis: Phase 2 in preparation
Oncology beyond MPNs – key highlights
In July, the FDA granted approval for Monjuvi®
(tafasitamab-cxix), an Fc-engineered anti-CD19 antibody, in
combination with lenalidomide for the treatment of adult patients
with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
and who are not eligible for autologous stem cell transplant
(ASCT). Monjuvi was reviewed under Priority Review and granted
accelerated approval based on overall response rate data from the
L-MIND trial of tafasitamab in combination with lenalidomide.
Incyte and MorphoSys will co-commercialize Monjuvi in the U.S.
Medical and commercial teams from both companies were ready for the
early approval and launch activities are already underway,
including engagements with prescribing physicians and payors.
In May, Incyte and MorphoSys announced the validation of the
European Marketing Authorization Application (MAA) for tafasitamab.
Incyte has exclusive development and commercialization rights to
tafasitamab outside of the U.S.
Updated results from the ongoing Phase 2 L-MIND study
investigating the combination of tafasitamab and lenalidomide in
patients with relapsed or refractory DLBCL (r/r DLBCL) were
reported at EHA. The results were consistent with the primary
analysis and those included in the U.S. prescribing information,
and confirmed the durability of the response and measurements of
overall survival of tafasitamab in combination with lenalidomide
followed by tafasitamab monotherapy in ASCT-ineligible patients
with r/r DLBCL.
In July, Incyte and Novartis announced that the REACH3 study,
evaluating ruxolitinib in patients with steroid-refractory chronic
graft-versus-host disease (GVHD), met its primary endpoint of
overall response rate (ORR) at Month 6 and both key secondary
endpoints (modified Lee symptom scale and failure-free survival).
No new safety signals were observed, and the ruxolitinib safety
profile in REACH3 was consistent with that seen in previously
reported studies. REACH3 is the largest randomized trial ever
conducted in the steroid-refractory chronic GVHD setting. Data are
being prepared for presentation at an upcoming medical meeting and
for regulatory submission.
Indication and status
ruxolitinib (JAK1/JAK2)
Steroid-refractory chronic GVHD: Phase 3
(REACH3)1 Primary endpoint met
itacitinib (JAK1)
Treatment-naïve chronic GVHD: Phase 3
(GRAVITAS-309)
pemigatinib (FGFR1/2/3)
Cholangiocarcinoma: Phase 2 (FIGHT-202),
Phase 3 (FIGHT-302); MAA under review
Bladder cancer: Phase 2 (FIGHT-201,
FIGHT-205)
8p11 MPN: Phase 2 (FIGHT-203)
Tumor agnostic: Phase 2 (FIGHT-207)
tafasitamab
(CD19)2
r/r DLBCL: Phase 2 (L-MIND); Phase 3
(B-MIND); MAA under review
First-line DLBCL: Phase 1b
(First-MIND)
parsaclisib (PI3Kδ)
Follicular lymphoma: Phase 2
(CITADEL-203)
Marginal zone lymphoma: Phase 2
(CITADEL-204)
Mantle cell lymphoma: Phase 2
(CITADEL-205)
retifanlimab (PD-1)3
MSI-high endometrial cancer: Phase 2
(POD1UM-101)
Merkel cell carcinoma: Phase 2
(POD1UM-201)
SCAC: Phase 2 (POD1UM-202); Phase 3
(POD1UM-303) in preparation
NSCLC: Phase 3 (POD1UM-304) in
preparation
1)
Clinical development of
ruxolitinib in GVHD conducted in collaboration with Novartis
2)
Development of tafasitamab in
collaboration with MorphoSys
3)
Retifanlimab licensed from
MacroGenics; SCAC = squamous cell carcinoma of the anal canal
Inflammation and Autoimmunity (IAI) – key highlights
The 44-week long-term safety and efficacy portions of both the
TRuE-AD1 and TRuE-AD2 Phase 3 trials of ruxolitinib cream in
patients with mild-to-moderate atopic dermatitis are proceeding as
planned, and the NDA submission is expected at the end of 2020.
Data from the randomized Phase 2 trial of ruxolitinib cream in
patients with vitiligo were recently published in The Lancet. The
two randomized Phase 3 trials in the TRuE-V pivotal program
evaluating ruxolitinib cream in patients with vitiligo are
proceeding as planned, with results expected in 2021.
Indication and status
ruxolitinib cream (JAK1/JAK2)
Atopic dermatitis: Phase 3 (TRuE-AD1,
TRuE-AD2; primary endpoints met)
Vitiligo: Phase 3 (TRuE-V1, TRuE-V2)
INCB54707 (JAK1)
Hidradenitis suppurativa: Phase 2
parsaclisib (PI3Kδ)
Autoimmune hemolytic anemia: Phase 2
INCB00928 (ALK2)
Fibrodysplasia ossificans progressiva:
Phase 2 in preparation
Discovery and early development – key highlights
Based on emerging data from the LSD1 inhibitor program,
development of INCB59872 has been discontinued. Incyte’s portfolio
of other earlier-stage clinical candidates is summarized below.
Modality
Candidates
Small molecules
INCB01158 (ARG)1, INCB81776 (AXL/MER),
epacadostat (IDO1), INCB86550 (PD-L1)
Monoclonal antibodies2
INCAGN1876 (GITR), INCAGN2385 (LAG-3),
INCAGN1949 (OX40), INCAGN2390 (TIM-3)
Bispecific antibodies
MCLA-145 (PD-L1xCD137)3
1)
INCB01158 development in
collaboration with Calithera
2)
Discovery collaboration with
Agenus
3)
MCLA-145 development in
collaboration with Merus
Potential therapies for patients with COVID-19
There are several ongoing studies of ruxolitinib, conducted by
Incyte alone or in collaboration with Novartis, and of baricitinib,
conducted by Lilly, in patients with COVID-19. Initial results from
these trials are expected in the second half of 2020.
Incyte and Lilly have amended their agreement to enable Lilly to
move rapidly in the development and commercialization of
baricitinib as a potential therapy for patients with COVID-19,
moving financial obligations post-approval.
Status
ruxolitinib (JAK1/JAK2)
COVID-19 associated cytokine storm: Phase
3 (RUXCOVID1; 369-DEVENT)
baricitinib (JAK1/JAK2)2
Hospitalized patients with COVID-19: Phase
3 (ACTT-23; COV-BARRIER)
1)
Sponsored by Incyte in the United
States and by Novartis outside of the United States
2)
Worldwide rights to baricitinib
licensed to Lilly: approved as Olumiant in multiple territories
globally for certain patients with moderate-to-severe rheumatoid
arthritis
3)
ACTT-2 agreement with the
National Institute of Allergy and Infectious Diseases (NIAID), part
of the National Institutes of Health
Partnered – key highlights
In May, Incyte and Novartis announced the FDA approval of
TabrectaTM (capmatinib) for the treatment of adult patients with
metastatic non-small cell lung cancer (NSCLC) whose tumors have a
mutation that leads to MET exon 14 skipping (METex14) as detected
by an FDA-approved test. Tabrecta was reviewed under Priority
Review and granted accelerated approval based on Phase 2 data in
first-line and previously treated patients with METex14 mutated
NSCLC.
In June, the Japanese Ministry of Health, Labour and Welfare
(MHLW) approved TabrectaTM (capmatinib) for METex14
mutation-positive advanced and/or recurrent unresectable NSCLC.
Indication and status
baricitinib (JAK1/JAK2)1
Atopic dermatitis: Phase 3 (BREEZE-AD)
Systemic lupus erythematosus: Phase 3
Severe alopecia areata: Phase 3
(BRAVE-AA1)
capmatinib (MET)2
NSCLC (with MET exon 14 skipping
mutations): Approved as Tabrecta in U.S. and Japan
1)
Worldwide rights to baricitinib
licensed to Lilly: approved as Olumiant in multiple territories
globally for certain patients with moderate-to-severe rheumatoid
arthritis
2)
Worldwide rights to capmatinib
licensed to Novartis
2020 Second Quarter Financial Results
The financial measures presented in this press release for the
three and six months ended June 30, 2020 and 2019 have been
prepared by the Company in accordance with U.S. Generally Accepted
Accounting Principles (“GAAP”), unless otherwise identified as a
Non-GAAP financial measure. Management believes that Non-GAAP
information is useful for investors, when considered in conjunction
with Incyte’s GAAP disclosures. Management uses such information
internally and externally for establishing budgets, operating goals
and financial planning purposes. These metrics are also used to
manage the Company’s business and monitor performance. The Company
adjusts, where appropriate, for expenses in order to reflect the
Company’s core operations. The Company believes these adjustments
are useful to investors by providing an enhanced understanding of
the financial performance of the Company’s core operations. The
metrics have been adopted to align the Company with disclosures
provided by industry peers.
Non-GAAP information is not prepared under a comprehensive set
of accounting rules and should only be used in conjunction with and
to supplement Incyte’s operating results as reported under GAAP.
Non-GAAP measures may be defined and calculated differently by
other companies in our industry.
Financial Highlights
Financial Highlights
(unaudited, in thousands,
except per share amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
Total GAAP revenue
$
688,043
$
529,932
$
1,256,550
$
1,027,789
Total GAAP operating income (loss)
230,773
98,612
(433,231
)
172,682
Total Non-GAAP operating income (loss)
288,514
151,219
(320,966
)
277,936
GAAP net income (loss)
290,298
105,318
(430,344
)
207,630
Non-GAAP net income (loss)
273,578
162,469
(345,342
)
297,011
GAAP basic EPS
$
1.33
$
0.49
$
(1.98
)
$
0.97
Non-GAAP basic EPS
$
1.26
$
0.76
$
(1.59
)
$
1.39
GAAP diluted EPS
$
1.32
$
0.48
$
(1.98
)
$
0.96
Non-GAAP diluted EPS
$
1.24
$
0.75
$
(1.59
)
$
1.37
Revenue Details
Revenue Details
(unaudited, in
thousands)
Three Months Ended
Six Months Ended
June 30,
%
June 30,
%
2020
2019
Change
2020
2019
Change
Revenues:
Jakafi net product revenue
$
473,706
$
409,506
16
%
$
933,185
$
785,117
19
%
Iclusig net product revenue
22,798
24,391
(7
%)
50,046
45,029
11
%
Pemazyre net product revenue
3,786
-
3,786
-
Jakavi product royalty revenues
66,217
56,895
16
%
122,550
102,466
20
%
Olumiant product royalty revenues
25,830
19,140
35
%
51,277
35,177
46
%
Tabrecta product royalty revenues
706
-
706
-
Product and royalty revenues
593,043
509,932
16
%
1,161,550
967,789
20
%
Milestone and contract revenues
95,000
20,000
375
%
95,000
60,000
58
%
Total GAAP revenues
$
688,043
$
529,932
30
%
$
1,256,550
$
1,027,789
22
%
Product and Royalty Revenues Product and royalty revenues
for the three and six months ended June 30, 2020 increased 16% and
20%, respectively, over the prior year comparative periods
primarily as a result of increases in Jakafi net product revenues
and higher product royalty revenues from Jakavi and Olumiant.
Jakafi net product revenues for the three and six months ended June
30, 2020 increased 16% and 19%, respectively, over the prior year
comparative periods, primarily driven by growth in patient demand
across all indications.
Operating Expenses
Operating Expense
Summary
(unaudited, in
thousands)
Three Months Ended
Six Months Ended
June 30,
%
June 30,
%
2020
2019
Change
2020
2019
Change
GAAP cost of product revenues
$
33,364
$
29,406
13
%
$
60,683
$
51,994
17
%
Non-GAAP cost of product revenues1
27,734
23,846
16
%
49,444
40,874
21
%
GAAP research and development
286,601
289,363
(1
%)
1,371,888
559,908
145
%
Non-GAAP research and development2
254,108
261,747
(3
%)
1,310,682
504,870
160
%
GAAP selling, general and
administrative
117,998
105,943
11
%
229,146
229,926
(0
%)
Non-GAAP selling, general and
administrative3
104,434
93,120
12
%
202,007
204,109
(1
%)
GAAP change in fair value of
acquisition-related contingent consideration
6,054
6,608
(8
%)
12,681
13,279
(5
%)
Non-GAAP change in fair value of
acquisition-related contingent consideration4
-
-
-
-
GAAP collaboration loss sharing
13,253
-
15,383
-
Non-GAAP collaboration loss sharing
13,253
-
15,383
-
1. Non-GAAP cost of product revenues excludes the amortization
of licensed intellectual property for Iclusig relating to the
acquisition of the European business of ARIAD Pharmaceuticals, Inc.
and the cost of stock-based compensation. 2. Non-GAAP research and
development expenses exclude the cost of stock-based compensation.
3. Non-GAAP selling, general and administrative expenses exclude
the cost of stock-based compensation. 4. Non-GAAP change in fair
value of acquisition-related contingent consideration is null.
Research and development expenses GAAP and Non-GAAP
research and development expense for the three months ended June
30, 2020 decreased 1% and 3%, respectively, compared to the same
period in 2019. For the six months ended June 30, 2020, GAAP and
Non-GAAP research and development expense increased 145% and 160%,
respectively, compared to the same period in 2019, primarily due to
upfront consideration of $805 million related to our collaborative
agreement with MorphoSys.
Selling, general and administrative expenses GAAP and
Non-GAAP selling, general and administrative expenses for the three
months ended June 30, 2020 increased 11% and 12%, respectively,
compared to the same period in 2019, primarily due to increased
headcount and commercialization efforts of our products. For the
six months ended June 30, 2020, GAAP and Non-GAAP selling, general
and administrative expenses remained relatively flat compared to
the same period in 2019.
Other Financial Information
Operating income (loss) GAAP and Non-GAAP operating
income for the three months ended June 30, 2020 increased compared
to the same period in 2019, due to growth in both product and
royalty revenues and milestone and contract revenues. For the six
months ended June 30, 2020 we recorded an operating loss compared
to operating income for the same period in 2019, on both a GAAP and
Non-GAAP basis, primarily due to upfront consideration related to
our collaborative agreement with MorphoSys, partially offset by the
growth in product and royalty revenues.
Cash, cash equivalents and marketable securities position
As of June 30, 2020 and December 31, 2019, cash, cash equivalents
and marketable securities totaled $1.6 billion and $2.1 billion,
respectively. The decrease reflects the upfront payment and stock
purchase related to our collaborative agreement with MorphoSys and
was partially offset by the cash flow generated during this
six-month period.
2020 Financial Guidance
The Company has reaffirmed its full year 2020 financial
guidance, as detailed below. The R&D expense guidance excludes
$805 million of upfront consideration paid under the MorphoSys
collaboration. The financial guidance also excludes the impact of
any potential future strategic transactions.
All data in millions
Current
Previous
Jakafi net product revenues
$1,880 - $1,950
Unchanged
Iclusig net product revenues
$100 - $105
Unchanged
GAAP Cost of product revenues
$130 - $135
Unchanged
Non-GAAP Cost of product revenues1
$107 - $112
Unchanged
GAAP Research and development expenses
$1,210 - $1,280
Unchanged
Non-GAAP Research and development
expenses2
$1,079 - $1,149
Unchanged
GAAP Selling, general and administrative
expenses
$505 - $535
Unchanged
Non-GAAP Selling, general and
administrative expenses2
$447 - $477
Unchanged
GAAP Change in fair value of
acquisition-related contingent consideration
$25 - $27
Unchanged
Non-GAAP Change in fair value of
acquisition-related contingent consideration3
$0
Unchanged
1. Adjusted to exclude the amortization of licensed intellectual
property for Iclusig relating to the acquisition of the European
business of ARIAD Pharmaceuticals, Inc. and the estimated cost of
stock-based compensation. 2. Adjusted to exclude the estimated cost
of stock-based compensation. 3. Adjusted to exclude the change in
fair value of estimated future royalties relating to sales of
Iclusig in the licensed territory relating to the acquisition of
the European business of ARIAD Pharmaceuticals, Inc.
Future Non-GAAP financial measures may also exclude impairment
of goodwill or other assets, changes in the fair value of equity
investments in our collaboration partners, non-cash interest
expense related to the amortization of the initial discount on our
2020 convertible senior notes and the impact on our tax provision
of discrete changes in our valuation allowance position on deferred
tax assets.
Conference Call and Webcast Information
Incyte will hold a conference call and webcast this morning at
8:00 a.m. EDT. To access the conference call, please dial
877-407-3042 for domestic callers or 201-389-0864 for international
callers. When prompted, provide the conference identification
number, 13706620.
If you are unable to participate, a replay of the conference
call will be available for 90 days. The replay dial-in number for
the United States is 877-660-6853 and the dial-in number for
international callers is 201-612-7415. To access the replay you
will need the conference identification number, 13706620.
The conference call will also be webcast; the livestream and the
replay can be accessed at investor.incyte.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics.
For additional information on Incyte, please visit Incyte.com
and follow @Incyte.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for treatment of steroid-refractory acute GVHD in adult
and pediatric patients 12 years and older.
Jakafi is also indicated for treatment of polycythemia vera (PV)
in adults who have had an inadequate response to or are intolerant
of hydroxyurea as well as adults with intermediate or high-risk
myelofibrosis (MF), including primary MF, post-polycythemia vera MF
and post-essential thrombocythemia MF.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
About Monjuvi® (tafasitamab-cxix)
Monjuvi is a humanized Fc-modified cytolytic CD19 targeting
monoclonal antibody. In 2010, MorphoSys licensed exclusive
worldwide rights to develop and commercialize tafasitamab from
Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc
domain, which mediates B-cell lysis through apoptosis and immune
effector mechanism including antibody-dependent cell-mediated
cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis
(ADCP).
Monjuvi is approved by the U.S. Food and Drug Administration in
combination with lenalidomide for the treatment of adult patients
with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)
not otherwise specified, including DLBCL arising from low grade
lymphoma, and who are not eligible for autologous stem cell
transplant (ASCT).
In January 2020, MorphoSys and Incyte entered into a
collaboration and licensing agreement to further develop and
commercialize Monjuvi globally. Monjuvi will be co-commercialized
by Incyte and MorphoSys in the United States. Incyte has exclusive
commercialization rights outside the United States.
A marketing authorization application (MAA) seeking the approval
of tafasitamab in combination with lenalidomide in the EU has been
validated by the European Medicines Agency (EMA) and is currently
under review for the treatment of adult patients with relapsed or
refractory DLBCL, including DLBCL arising from low grade lymphoma,
who are not candidates for ASCT.
Tafasitamab is being clinically investigated as a therapeutic
option in B-cell malignancies in a number of ongoing combination
trials.
Monjuvi is a registered trademark of MorphoSys AG. XmAb® is a
registered trademark of Xencor, Inc.
About Pemazyre® (pemigatinib)
Pemazyre is a kinase inhibitor indicated for the treatment of
adults with previously treated, unresectable locally advanced or
metastatic cholangiocarcinoma with a fibroblast growth factor
receptor 2 (FGFR2) fusion or other rearrangement as detected by an
FDA-approved test.
Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms
1, 2 and 3 which, in preclinical studies, has demonstrated
selective pharmacologic activity against cancer cells with FGFR
alterations.
Pemazyre is marketed by Incyte in the United States. Incyte has
granted Innovent Biologics, Inc. rights to develop and
commercialize pemigatinib in hematology and oncology in Mainland
China, Hong Kong, Macau and Taiwan. Incyte has retained all other
rights to develop and commercialize pemigatinib outside of the
United States.
Additionally, Incyte’s marketing authorization application (MAA)
seeking the approval of pemigatinib for patients with
cholangiocarcinoma in the EU has been validated by the European
Medicines Agency (EMA) and is currently under review for the
treatment of adults with locally advanced or metastatic
cholangiocarcinoma with a fibroblast growth factor receptor 2
(FGFR2) fusion or rearrangement that is relapsed or refractory
after at least one line of systemic therapy.
Pemazyre is a trademark of Incyte Corporation.
About Iclusig® (ponatinib) tablets
Iclusig targets not only native BCR-ABL but also its isoforms
that carry mutations that confer resistance to treatment, including
the T315I mutation, which has been associated with resistance to
other approved TKIs.
In the EU, Iclusig is approved for the treatment of adult
patients with chronic phase, accelerated phase or blast phase
chronic myeloid leukemia (CML) who are resistant to dasatinib or
nilotinib; who are intolerant to dasatinib or nilotinib and for
whom subsequent treatment with imatinib is not clinically
appropriate; or who have the T315I mutation, or the treatment of
adult patients with Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib;
who are intolerant to dasatinib and for whom subsequent treatment
with imatinib is not clinically appropriate; or who have the T315I
mutation.
Incyte has an exclusive license from ARIAD Pharmaceuticals,
Inc., since acquired by Takeda Pharmaceutical Company Limited, to
develop and commercialize Iclusig in the European Union and 22
other countries, including Switzerland, Norway, Turkey, Israel and
Russia.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this release contain predictions, estimates
and other forward-looking statements, including without limitation
statements regarding: the expected timing for submission of NDAs
for ruxolitinib cream for atopic dermatitis and for the once-a-day
formulation of ruxolitinib; plans to initiate pivotal trials of the
combination of ruxolitinib and parsaclisib; plans for ruxolitinib
combination trials with INCB57643 (BET) and INCB00928 (ALK2); plans
and expectations for the rest of the Company’s development
portfolio, including the timing of receipt and announcement of
clinical trial results and progress of development programs for
ruxolitinib cream for vitiligo, retifanlimab and ruxolitinib for
COVID-19; and the Company’s reaffirmed financial guidance for 2020
and the expectations underlying such guidance.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: further
research and development and the results of clinical trials
possibly being unsuccessful or insufficient to meet applicable
regulatory standards or warrant continued development; the ability
to enroll sufficient numbers of subjects in clinical trials and the
ability to enroll subjects in accordance with planned schedules;
the effects of the COVID-19 pandemic and measures to address the
pandemic on the Company’s clinical trials, supply chain and other
third-party providers, sales and marketing efforts, and business,
development and discovery operations; determinations made by the
FDA and regulatory agencies outside of the United States; the
Company's dependence on its relationships with and changes in the
plans of its collaboration partners; the efficacy or safety of the
Company’s products and the products of the Company’s collaboration
partners; the acceptance of the Company’s products and the products
of the Company’s collaboration partners in the marketplace; market
competition; unexpected variations in the demand for the Company’s
products and the products of the Company’s collaboration partners;
the effects of announced or unexpected price regulation or
limitations on reimbursement or coverage for the Company’s products
and the products of the Company’s collaboration partners; sales,
marketing, manufacturing and distribution requirements, including
the Company’s and its collaboration partners’ ability to
successfully commercialize and build commercial infrastructure for
newly approved products and any additional products that become
approved; greater than expected expenses, including expenses
relating to litigation or strategic activities; and other risks
detailed from time to time in the Company’s reports filed with the
Securities and Exchange Commission, including its quarterly report
on Form 10-Q for the quarter ended March 31, 2020. The Company
disclaims any intent or obligation to update these forward-looking
statements.
INCYTE CORPORATION
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(unaudited, in thousands,
except per share amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
GAAP
GAAP
Revenues:
Product revenues, net
$
500,290
$
433,897
$
987,017
$
830,146
Product royalty revenues
92,753
76,035
174,533
137,643
Milestone and contract revenues
95,000
20,000
95,000
60,000
Total revenues
688,043
529,932
1,256,550
1,027,789
Costs and expenses:
Cost of product revenues (including
definite-lived intangible amortization)
33,364
29,406
60,683
51,994
Research and development
286,601
289,363
1,371,888
559,908
Selling, general and administrative
117,998
105,943
229,146
229,926
Change in fair value of
acquisition-related contingent consideration
6,054
6,608
12,681
13,279
Collaboration loss sharing
13,253
-
15,383
-
Total costs and expenses
457,270
431,320
1,689,781
855,107
Income (loss) from operations
230,773
98,612
(433,231
)
172,682
Other income (expense), net
4,817
15,000
13,479
24,373
Interest expense
(600
)
(316
)
(1,202
)
(651
)
Unrealized gain (loss) on long term
investments
72,274
(4,625
)
24,142
16,364
Income (loss) before provision for income
taxes
307,264
108,671
(396,812
)
212,768
Provision for income taxes
16,966
3,353
33,532
5,138
Net income (loss)
$
290,298
$
105,318
$
(430,344
)
$
207,630
Net income (loss) per share:
Basic
$
1.33
$
0.49
$
(1.98
)
$
0.97
Diluted
$
1.32
$
0.48
$
(1.98
)
$
0.96
Shares used in computing net income (loss)
per share:
Basic
217,549
214,620
217,135
214,342
Diluted
220,434
217,483
217,135
217,274
INCYTE CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEETS
(unaudited, in
thousands)
June 30,
December 31,
2020
2019
ASSETS
Cash, cash equivalents and marketable
securities
$
1,589,486
$
2,117,554
Accounts receivable
420,250
308,809
Property and equipment, net
453,777
377,567
Finance lease right-of-use assets, net
28,133
29,058
Inventory
25,889
16,505
Prepaid expenses and other assets
107,402
94,179
Long term investments
248,731
133,657
Other intangible assets, net
183,060
193,828
Goodwill
155,593
155,593
Total assets
$
3,212,321
$
3,426,750
LIABILITIES AND STOCKHOLDERS’
EQUITY
Accounts payable, accrued expenses and
other liabilities
$
542,023
$
500,462
Finance lease liabilities
33,106
32,582
Convertible senior notes
18,588
18,300
Acquisition-related contingent
consideration
274,000
277,000
Stockholders’ equity
2,344,604
2,598,406
Total liabilities and stockholders’
equity
$
3,212,321
$
3,426,750
INCYTE CORPORATION
RECONCILIATION OF GAAP NET
INCOME (LOSS) TO SELECTED NON-GAAP ADJUSTED INFORMATION
(unaudited, in thousands,
except per share amounts)
Three Months Ended
Six Months Ended
June 30,
June 30,
2020
2019
2020
2019
GAAP Net Income (Loss)
$
290,298
$
105,318
$
(430,344
)
$
207,630
Adjustments1:
Non-cash stock compensation from equity
awards (R&D)2
32,493
27,616
61,206
55,038
Non-cash stock compensation from equity
awards (SG&A)2
13,564
12,823
27,139
25,817
Non-cash stock compensation from equity
awards (COGS)2
246
176
471
352
Non-cash interest expense related to
convertible notes3
226
215
449
428
Changes in fair value of equity
investments4
(72,274
)
4,625
(24,142
)
(16,364
)
Amortization of acquired product
rights5
5,384
5,384
10,768
10,768
Change in fair value of contingent
consideration6
6,054
6,608
12,681
13,279
Tax effect of Non-GAAP adjustments7
(2,413
)
(296
)
(3,570
)
63
Non-GAAP Net Income (Loss)
$
273,578
$
162,469
$
(345,342
)
$
297,011
Non-GAAP net income (loss) per share:
Basic
$
1.26
$
0.76
$
(1.59
)
$
1.39
Diluted
$
1.24
$
0.75
$
(1.59
)
$
1.37
Shares used in computing Non-GAAP net
income (loss) per share:
Basic
217,549
214,620
217,135
214,342
Diluted
220,434
217,483
217,135
217,274
1. Included within the Milestone and contract revenues line item
in the Condensed Consolidated Statements of Operations (in
thousands) for the three and six months ended June 30, 2020 are
milestones of $95,000 earned from our collaborative partners as
compared to upfront consideration and milestones of $20,000 and
$60,000, respectively, for the same periods in 2019. Included
within the Research and development expenses line item in the
Condensed Consolidated Statements of Operations (in thousands) for
the three and six months ended June 30, 2020 are upfront
consideration and milestones of $3,500 and $809,032, respectively,
related to our collaborative partners as compared to $25,000 for
the same periods in 2019. 2. As included within the Cost of product
revenues (including definite-lived intangible amortization) line
item; the Research and development expenses line item; and the
Selling, general and administrative expenses line item in the
Condensed Consolidated Statements of Operations. 3. As included
within the Interest expense line item in the Condensed Consolidated
Statements of Operations. 4. As included within the Unrealized gain
(loss) on long term investments line item in the Condensed
Consolidated Statements of Operations. 5. As included within the
Cost of product revenues (including definite-lived intangible
amortization) line item in the Condensed Consolidated Statements of
Operations. Acquired product rights of licensed intellectual
property for Iclusig is amortized utilizing a straight-line method
over the estimated useful life of 12.5 years. 6. As included within
the Change in fair value of acquisition-related contingent
consideration line item in the Condensed Consolidated Statements of
Operations. 7. As included within the Provision for income taxes
line item in the Condensed Consolidated Statements of Operations.
Income tax effects of Non-GAAP adjustments are calculated using the
applicable statutory tax rate for the jurisdictions in which the
charges are incurred, while taking into consideration any valuation
allowances.
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version on businesswire.com: https://www.businesswire.com/news/home/20200804005177/en/
Incyte Contacts Media
Catalina Loveman +1 302 498 6171 cloveman@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
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