Larotrectinib New Drug Application (NDA) PDUFA
date is November 26, 2018
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company
developing highly selective medicines for patients with genomically
defined cancers, today reported third quarter 2018 financial
results.
“In the third quarter we made significant progress across our
pipeline,” said Josh Bilenker, M.D., chief executive officer
of Loxo Oncology. “At ESMO, larotrectinib investigators
provided a comprehensive program update that included durability
and additional response data in patients with TRK fusion cancers.
Medical meeting updates for LOXO-292 in September and October
showed encouraging ongoing durability of response for patients with
RET-driven cancers. Taken together, these data have increased our
conviction around a foundational company thesis—that selective,
purpose-built medicines offer the best opportunity for durable
efficacy and a manageable safety profile. In the fourth quarter, we
look forward to LOXO-305, our fourth program, entering the
clinic.”
Recent Highlights
Larotrectinib
-
- European Society for Medical Oncology (ESMO)
2018 Congress: On October 21, 2018, updated
clinical data for larotrectinib were presented at ESMO. The oral
presentation provided approximately one year of additional
follow-up for the primary dataset, the 55 patients with TRK fusion
cancer described in the larotrectinib New England Journal of
Medicine publication from February 2018. In addition, the update
included data for a supplementary dataset, an additional 67
patients with TRK fusion cancer who were subsequently enrolled
across the larotrectinib development program. Response evaluations
were based on investigator assessment. As of a data cut-off date of
July 30, 2018, in the primary dataset (n=55), the overall response
rate (ORR) was 80% (44/55) (95% CI: 67-90%) and in the
supplementary dataset (n=67), the ORR was 81% (44/54) (95% CI:
69-91%). Across both datasets, the ORR was 81% (88/109) (95% CI:
72-88%). The ORR analyses for the supplementary and integrated
datasets included nine patients with unconfirmed partial responses
awaiting confirmatory response assessments, but did not include 13
patients who were awaiting an initial response assessment and
continuing on study. Median duration of response (DOR) had not been
reached in either the primary dataset or supplementary dataset,
with median follow-up of 17.6 months and 7.4 months, respectively.
Larotrectinib was well tolerated, with the majority of adverse
events recorded as grade 1 or 2. The most common treatment-emergent
adverse events occurring in 15% or more of patients in the trial
were fatigue, dizziness, nausea, constipation, anemia, increased
alanine aminotransferase (ALT), increased aspartate
aminotransferase (AST), cough, diarrhea, vomiting, pyrexia,
dyspnea, headache, myalgia and peripheral oedema. See the presented
data here.
- Annual Meeting of the American Thyroid Association
(ATA): On October 4, 2018, clinical data for patients with
TRK fusion thyroid cancer enrolled in the larotrectinib development
program were presented in an oral presentation at ATA. See the
presented data here.
- International Association for the Study of Lung Cancer
(IASLC) 19th World Conference on Lung
Cancer: On September 24, 2018,
clinical data for patients with TRK fusion non-small cell lung
cancer (NSCLC) enrolled in the larotrectinib development program
were presented in a poster presentation at the IASLC World
Conference on Lung Cancer. The poster can be found here.
- Molecular Analysis for Personalised Therapy
2018 Congress: On September 15,
2018, Ventana Medical Systems, Inc., a member of
the Roche Group, and Loxo Oncology, presented a
co-authored poster on the analytical validation of Ventana’s
pan-TRK IHC assay at the Molecular Analysis for Personalised
Therapy 2018 Congress. These data, in addition to other
recently published evidence, suggest an annual incidence of
approximately 2,500 to 3,000 cases of TRK fusion cancer in the
United States. The poster can be found here.
- Integrative Therapies Program for Children with Cancer
(ITPCC): On September 13, 2018, clinical data for children
and adolescents with TRK fusion metastatic thyroid carcinoma
enrolled in the larotrectinib development program were presented at
the ITPCC conference. The poster can be found here.
- Publications
- Targeted Oncology
Publication: On October 2, 2018, a manuscript was
published online in Targeted Oncology detailing the potential
effectiveness of TRK inhibition, including larotrectinib treatment,
in patients with tumors harboring NTRK gene fusions, and the need
for effective testing strategies. The publication can be found
here.
- British Journal of Cancer
Publication: On September 17, 2018, a case report
was published in the British Journal of Cancer detailing a patient
with TRK fusion high-grade glioma treated with larotrectinib. The
publication can be found here.
- Cancer Publication: On
September 11, 2018, a manuscript was published online in Cancer
detailing the treatment of children with locally advanced TRK
fusion sarcoma who were treated preoperatively with larotrectinib
and underwent subsequent surgical resection. The publication can be
found here.
- JCO Precision Oncology
Publication: On August 2, 2018, a case report was
published in JCO Precision Oncology detailing an adolescent patient
with a TRK fusion undifferentiated sarcoma treated with
larotrectinib. The publication can be found here.
- European Marketing Authorization Application
(MAA): On August 27, 2018, Loxo Oncology
and Bayer announced that Bayer had submitted an MAA for
larotrectinib to the European Medicines Agency (EMA). More
information can be found here.
LOXO-195
- LOXO-195 Orphan Drug Designation (ODD): In
October, the U.S. Food and Drug Administration (FDA) granted ODD to
LOXO-195 for the treatment of solid tumors with neurotrophic
tyrosine receptor kinase (NTRK)-fusion proteins that have developed
acquired resistance to prior TRK inhibitor therapy. The FDA’s
Office of Orphan Drug Products grants orphan drug designation to
support the development of medicines for underserved patient
populations, or rare disorders, that affect fewer than 200,000
people in the United States. Orphan drug designation provides to
Loxo Oncology certain benefits, including market exclusivity upon
regulatory approval if received, exemption of FDA application fees
and tax credits for qualified clinical trials.
LOXO-292
- Annual Meeting of the ATA: On October 6, 2018,
updated interim clinical data for LOXO-292 from the global Phase
1/2 LIBRETTO-001 trial in patients with RET-mutant medullary
thyroid cancer (MTC) and RET fusion-positive thyroid cancer were
presented at the Annual Meeting of the ATA. The data presented were
based on a July 19, 2018 data cut-off date and included the 29
patients with RET-mutant MTC and the nine patients with RET
fusion-positive thyroid cancer who were included in the LOXO-292
presentation at the 2018 ASCO Annual Meeting. With 3.5 months of
additional follow-up since the ASCO presentation, LOXO-292
demonstrated encouraging, early evidence of durable activity.
Sixteen of 17 (94%) responding RET-mutant MTC patients remained on
therapy and in response (median follow-up of 7.6 months for all 29
patients; median follow-up of 8.4 months for responding patients).
Seven of seven (100%) responding RET fusion-positive thyroid
remained on therapy and in response (median follow-up of 7.6 months
for all nine patients; median follow-up of 8.5 months for
responding patients). In RET-mutant MTC, the overall response rate
was 59% (17/29) (95% CI: 39-77%) and the confirmed overall response
rate was 56% (15/27) (95% CI: 35-75%). Of nine patients with RET
fusion-positive thyroid cancer, the confirmed overall response rate
was 78% (7/9) (95% CI: 40-97%). Of the 82 patients in the safety
analysis, most treatment-emergent adverse events were Grade 1 in
severity and judged by the investigator as not related to LOXO-292.
See the presented data here.
- IASLC 19th World Conference on Lung Cancer: On
September 25, 2018, updated interim clinical data for LOXO-292 from
the global Phase 1/2 LIBRETTO-001 trial in patients with RET
fusion-positive NSCLC were presented at the IASLC World Conference
on Lung Cancer. The data presented were based on a July 19, 2018
data cut-off date and included the 38 patients with RET
fusion-positive NSCLC who were initially included in the LOXO-292
presentation at the 2018 ASCO Annual Meeting. With 3.5 months of
additional follow-up since the ASCO presentation, LOXO-292
demonstrated encouraging, early evidence of durable activity, with
25 of 26 (96%) responding RET fusion-positive NSCLC patients
remaining on therapy and 24 of 26 (92%) remaining in response
(median follow-up of 8.5 months for all 38 patients; median
follow-up of 9.5 months for responding patients). The overall
response rate was 68% (26/38) (95% CI: 51-83%) and the confirmed
overall response rate was 68% (25/37) (95% CI: 50-82%). Of the 82
patients in the safety analysis, most treatment-emergent adverse
events were Grade 1 in severity and judged by the investigator as
not related to LOXO-292. See the presented data here.
- LOXO-292 Breakthrough Therapy Designations:
The FDA granted three Breakthrough Therapy Designations to
LOXO-292:
- for the treatment of patients with metastatic RET
fusion-positive non-small cell lung cancer who require systemic
therapy and have progressed following platinum-based chemotherapy
and an anti-PD-1 or anti-PD-L1 therapy;
- for the treatment of patients with RET-mutant medullary thyroid
cancer who require systemic therapy, have progressed following
prior treatment and have no acceptable alternative treatment
options; and for
- for the treatment of patients with advanced RET fusion-positive
thyroid cancer who require systemic therapy, have progressed
following prior treatment and have no acceptable alternative
treatment options.More information can be found here and here.
- LOXO-292 Orphan Drug Designation: In October,
the FDA granted ODD to LOXO-292 for the treatment of pancreatic
cancer. The FDA’s Office of Orphan Drug Products grants orphan drug
designation to support the development of medicines for underserved
patient populations, or rare disorders, that affect fewer than
200,000 people in the United States. Orphan drug designation
provides to Loxo Oncology certain benefits, including market
exclusivity upon regulatory approval if received, exemption of FDA
application fees and tax credits for qualified clinical
trials.
LOXO-305
- Society of Hematologic Oncology (SOHO) Annual
Meeting: On September 12, 2018,
preclinical characterization data for LOXO-305 were presented at
the SOHO Annual Meeting. The poster can be found here.
Third Quarter 2018 Financial Results
As of September 30, 2018, Loxo Oncology had aggregate cash, cash
equivalents and investments of $647.6 million, compared to $626.2
million as of December 31, 2017.
Revenue from the collaboration agreement was $42.5 million for
the third quarter of 2018, compared to none for the third quarter
of 2017. This represents $52.9 million in revenue recognized from
the $400.0 million upfront payment from the Bayer collaboration
offset by $10.5 million, Loxo Oncology’s share of the joint
larotrectinib co-promotion costs in the same period.
Revenue from the collaboration agreement was $123.5 million for
the nine months ended September 30, 2018, compared to none for the
nine months ended September 30, 2017. This represents $147.0
million in revenue recognized from the $400.0 million upfront
payment from the Bayer collaboration offset by $23.5 million, Loxo
Oncology’s share of the joint larotrectinib co-promotion costs in
the same period. Loxo Oncology recognizes revenue from the upfront
payment on a proportional performance basis utilizing a calculation
based on quarterly research and development spending associated
with larotrectinib and LOXO-195, relative to cumulative and
forecasted research and development spending on larotrectinib and
LOXO-195 over the course of the collaboration agreement. As a
result, the quarterly revenue recognized for the upfront payment
varies from quarter to quarter. A supporting schedule that shows
the different components of revenue from the collaboration
agreement is included with the attached financial statements.
Research and development expenses were $56.9 million for the
third quarter of 2018 compared to $64.8 million for the third
quarter of 2017. This decrease was primarily due to a non-recurring
charge related to the $40.0 million asset acquisition of the BTK
inhibitor program from Redx in the third quarter of 2017, offset by
expanded development expenses across the LOXO-292 and LOXO-305
programs and higher employment costs primarily due to increased
headcount. These numbers are net of 50/50 cost-sharing with Bayer
for larotrectinib and LOXO-195 development costs. Loxo Oncology
recognized research and development-related stock-based
compensation expense of $4.2 million during the third quarter of
2018 as compared to $2.1 million for the third quarter of 2017.
Research and development expenses were $130.5 million for the
nine months ended September 30, 2018 compared to $109.3 million for
the nine months ended September 30, 2017. This increase was
primarily due to expanded development expenses across the LOXO-292
and LOXO-305 programs and higher employment costs primarily due to
increased headcount. These numbers are net of 50/50 cost-sharing
with Bayer for larotrectinib and LOXO-195 development costs. Loxo
Oncology recognized research and development-related stock-based
compensation expense of $14.3 million during the nine months ended
September 30, 2018 as compared to $8.0 million for the nine months
ended September 30, 2017.
General and administrative expenses were $15.9 million for the
third quarter of 2018 compared to $9.7 million for the third
quarter of 2017. The increase was primarily due to additional
headcount, associated employment costs, and general and
administrative professional fees. Loxo Oncology recognized general
and administrative-related stock-based compensation expense of $6.9
million during the third quarter of 2018 compared to $3.1 million
for the third quarter of 2017.
General and administrative expenses were $43.8 million for the
nine months ended September 30, 2018 compared to $21.0 million for
the nine months ended September 30, 2017. The increase was
primarily due to additional headcount, associated employment costs,
and general and administrative professional fees. Loxo Oncology
recognized general and administrative-related stock-based
compensation expense of $18.8 million during the nine months ended
September 30, 2018 compared to $6.7 million for the nine months
ended September 30, 2017.
Net loss was $27.1 million and $42.3 million for the three and
nine months ended September 30, 2018, respectively, compared to
$73.3 million and $128.2 million for the three and nine months
ended September 30, 2017, respectively. This decrease in net loss
was primarily driven by the revenue recognized from the $400.0
million upfront payment from the Bayer collaboration, the
larotrectinib and LOXO-195 development reimbursement from the Bayer
collaboration, offset by increases in operating expenses.
Non-GAAP net loss was $68.8 million and $156.2 million for the
three and nine months ended September 30, 2018, respectively,
compared to $28.1 million and $73.6 million for the three and nine
months ended September 30, 2017, respectively. This non-GAAP net
loss measure, more fully described below under “Non-GAAP Financial
Measures,” excludes the recognition of collaboration revenue
related to the Bayer upfront payment and share-based compensation
expenses. A reconciliation of the GAAP financial results to
non-GAAP financial results is included with the attached financial
statements.
Earnings Conference Call and Webcast
Information Loxo Oncology will host a
conference call today at 8:00 a.m. ET to discuss the
third quarter 2018 financial results and company updates. A live
webcast can be accessed under "Events & Presentations" in the
Investors & Media section of the company's website
at www.loxooncology.com. The conference call can be accessed
by dialing (877) 930-8065 (domestic) or (253) 336-8041
(international) and referring to conference ID 8379404. The webcast
will be archived and made available for replay on the company's
website beginning approximately two hours after the event.
About Loxo Oncology Loxo Oncology is
a biopharmaceutical company developing highly selective medicines
for patients with genomically defined cancers. Our pipeline focuses
on cancers that are uniquely dependent on single gene
abnormalities, such that a single drug has the potential to treat
the cancer with dramatic effect. We believe that the most
selective, purpose-built medicines have the highest probability of
maximally inhibiting the intended target, with the intention of
delivering best-in-class disease control and safety. Our management
team seeks out experienced industry partners, world-class
scientific advisors and innovative clinical-regulatory approaches
to deliver new cancer therapies to patients as quickly and
efficiently as possible. For more information, please visit the
company's website at www.loxooncology.com.
Forward Looking Statements This press
release contains "forward-looking" statements within the meaning of
the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as: "anticipate," "intend," "plan,"
"goal," "seek," "believe," "project," "estimate," "expect,"
"strategy," "future," "likely," "may," "should," "will" and similar
references to future periods. These statements are subject to
numerous risks and uncertainties that could cause actual results to
differ materially from what we expect. Examples of forward-looking
statements include, among others, the reporting, timing and success
of our clinical trials, the success of our efforts to commercialize
larotrectinib, and the timing or success of regulatory approvals in
the U.S. and in the E.U. Further information on potential risk
factors that could affect our business and its financial results
are detailed in our most recent Annual Report on Form 10-K, and
other reports as filed from time to time with the Securities and
Exchange Commission. We undertake no obligation to publicly update
any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Non-GAAP Financial Measures This press release
includes financial results prepared in accordance with accounting
principles generally accepted in the United
States (GAAP), and also certain historical non-GAAP financial
measures. In particular, we have provided non-GAAP net loss,
adjusted to exclude recognized collaboration revenue related to an
upfront payment, the acquisition of an in process R&D asset and
share-based compensation expenses. Non-GAAP financial measures are
not an alternative for financial measures prepared in accordance
with GAAP. For a reconciliation of these non-GAAP financial
measures to their most directly comparable GAAP financial measure,
see the table below. Non-GAAP financial measures may not be
comparable to similarly titled measures reported by other
companies, since not all companies may calculate these measures in
an identical manner and, therefore, it is not necessarily an
accurate measure of comparison between companies. However, we
believe the presentation of non-GAAP net loss, when viewed in
conjunction with our GAAP results, provides investors and
management with a more complete understanding of our ongoing and
projected operating performance because this measure excludes the
recognition of collaboration revenue from an upfront payment and
the acquisition of an in process R&D asset that are
non-recurring events and non-cash charges that are substantially
dependent on changes in the market price of our common stock. We
believe our non-GAAP net loss measure helps indicate underlying
trends in our business and is important in comparing current
results with prior period results.
Financials
|
|
LOXO ONCOLOGY, INC. |
Condensed Consolidated Balance
Sheets |
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
|
2018 |
|
2017 |
Assets |
|
(Unaudited) |
|
dude |
Cash, cash
equivalents and investments |
|
$ |
647,602 |
|
$ |
626,200 |
Receivable
from collaboration partner |
|
|
— |
|
|
150,000 |
Other
prepaid expenses and current assets |
|
|
6,309 |
|
|
5,607 |
Property
and equipment, net |
|
|
4,253 |
|
|
912 |
Other
assets |
|
|
1,064 |
|
|
723 |
|
|
Total assets |
|
|
659,228 |
|
|
783,442 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Accounts
payable |
|
|
2,018 |
|
|
3,996 |
Payable due
to collaboration partner |
|
|
2,576 |
|
|
— |
Accrued
expenses and other current liabilities |
|
|
43,739 |
|
|
22,537 |
Deferred
revenue |
|
|
231,680 |
|
|
378,699 |
|
|
Total liabilities |
|
|
280,013 |
|
|
405,232 |
Commitments
and contingencies |
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
Common
stock, $0.0001 par value; 125,000,000 shares authorized; 30,566,797
and 29,991,884 shares issued and outstanding at September 30, 2018
and December 31, 2017, respectively |
|
|
3 |
|
|
3 |
|
Additional
paid-in capital |
|
|
710,137 |
|
|
666,891 |
|
Accumulated
deficit |
|
|
(330,460 |
) |
|
(288,112 |
|
Other
comprehensive loss |
|
|
(465 |
) |
|
(572 |
|
|
Total stockholders'
equity |
|
|
379,215 |
|
|
378,210 |
|
|
Total liabilities and
stockholders' equity |
|
$ |
659,228 |
|
$ |
783,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOXO
ONCOLOGY, INC.Consolidated Statements of
Operations(unaudited)(in
thousands, except share and per share amounts)
|
Three Months
EndedSeptember 30, |
|
Nine Months
EndedSeptember 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from collaboration agreement |
$ |
42,470 |
|
$ |
— |
|
$ |
123,500 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
56,928 |
|
|
64,754 |
|
|
130,473 |
|
|
109,321 |
|
General and administrative |
|
15,864 |
|
|
9,680 |
|
|
43,800 |
|
|
20,968 |
|
Total operating expenses |
|
72,792 |
|
|
74,434 |
|
|
174,273 |
|
|
130,289 |
|
Loss from operations |
|
(30,322 |
) |
|
(74,434 |
) |
|
(50,773 |
) |
|
(130,289 |
) |
Interest income, net |
|
3,258 |
|
|
1,115 |
|
|
8,425 |
|
|
2,041 |
|
Net loss |
$ |
(27,064 |
) |
$ |
(73,319 |
) |
$ |
(42,348 |
) |
$ |
(128,248 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of common stock, basic and
diluted |
$ |
(0.89 |
) |
$ |
(2.45 |
) |
$ |
(1.40 |
) |
$ |
(4.68 |
) |
Weighted average shares outstanding, basic and
diluted |
|
30,502,789 |
|
|
29,872,198 |
|
|
30,230,160 |
|
|
27,391,020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LOXO
ONCOLOGY, INC.Reconciliation of GAAP Net Loss
to Non-GAAP Net
Loss(unaudited)(in thousands,
except share and per share amounts)
|
Three Months
EndedSeptember 30, |
|
Nine Months EndedSeptember
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss |
$ |
(27,064 |
) |
$ |
(73,319 |
) |
$ |
(42,348 |
) |
$ |
(128,248 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
from collaboration agreement |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
recognized from $400M upfront payment |
|
(52,938 |
) |
|
— |
|
|
(147,019 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of in
process R&D (IPR&D) asset |
|
|
|
|
|
|
|
|
|
|
|
|
included
in R&D expenses |
|
— |
|
|
40,000 |
|
|
— |
|
|
40,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based
compensation expenses |
|
|
|
|
|
|
|
|
|
|
|
|
included
in R&D expenses |
|
4,205 |
|
|
2,148 |
|
|
14,313 |
|
|
8,010 |
|
Share-based
compensation expenses |
|
|
|
|
|
|
|
|
|
|
|
|
included
in G&A expenses |
|
6,948 |
|
|
3,120 |
|
|
18,837 |
|
|
6,667 |
|
Total share-based
compensation expenses |
|
11,153 |
|
|
5,268 |
|
|
33,150 |
|
|
14,667 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total adjustments |
|
(41,785 |
) |
|
45,268 |
|
|
(113,869 |
) |
|
54,667 |
|
Non-GAAP net loss |
$ |
(68,849 |
) |
$ |
(28,051 |
) |
$ |
(156,217 |
) |
$ |
(73,571 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share
information: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share of
common stock, basic and diluted |
$ |
(2.26 |
) |
$ |
(0.94 |
) |
$ |
(5.17 |
) |
$ |
(2.69 |
) |
Weighted average shares
outstanding, basic and diluted |
|
30,502,789 |
|
|
29,872,198 |
|
|
30,230,160 |
|
|
27,391,020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
LOXO
ONCOLOGY, INC.Calculation of Revenue from
Collaboration
Agreement(unaudited)(in
thousands)
|
Three Months
EndedSeptember 30, |
|
Nine Months EndedSeptember
30, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront payment |
|
|
|
|
|
|
|
|
|
|
|
Revenue recognized from
$400M upfront payment |
$ |
52,938 |
|
$ |
— |
|
$ |
147,019 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
Milestones |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Royalties |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Co-promote |
|
|
|
|
|
|
|
|
|
|
|
Product
revenue subject to profit sharing (as recorded by Bayer) |
|
— |
|
|
— |
|
|
— |
|
|
— |
Combined
cost of goods sold, distribution, selling, general and |
|
|
|
|
|
|
|
|
|
|
|
administrative expenses |
|
(20,936 |
) |
|
— |
|
|
(47,038 |
) |
|
— |
Combined
collaboration co-promotion profit/(loss) |
|
(20,936 |
) |
|
— |
|
|
(47,038 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Loxo
Oncology’s 50/50 share of collaboration |
|
|
|
|
|
|
|
|
|
|
|
co-promotion profit/(loss) |
|
(10,468 |
) |
|
— |
|
|
(23,519 |
) |
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue from
collaboration agreement |
$ |
42,470 |
|
$ |
— |
|
$ |
123,500 |
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
Contacts for Loxo Oncology,
Inc.
Company: Lauren Cohen Director, Corporate Communications
lcohen@loxooncology.com
Investors: Peter Rahmer Endurance Advisors, LLC 415-515-9763
prahmer@enduranceadvisors.com
Media: Dan Budwick 1AB Media 973-271-6085 dan@1abmedia.com
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