- First presentation of initial LuMIERE Phase 1 clinical data for
FAP-2286 targeted radiotherapy candidate at SNMMI demonstrated a
manageable safety profile with preliminary evidence of activity
- Confirmed partial response in one patient in the lowest (3.7
GBq) dose cohort
- Recruitment of third of four planned dose cohorts is
ongoing
- Initiation of Phase 2 expansion cohorts in multiple tumor types
anticipated in Q4 2022
- Phase 3 ATHENA trial evaluating Rubraca® (rucaparib)
monotherapy versus placebo (ATHENA-MONO) in front-line maintenance
treatment of ovarian cancer presented at 2022 ASCO Annual Meeting
- Simultaneous publication in the Journal of Clinical Oncology
(JCO)
- Presented at Best of ASCO meeting series
- sNDA and Type II variation planned for submission in Q3
2022
- Two additional top-line Phase 3 data read-outs for Rubraca
expected in next three quarters
- $32.1M in Rubraca global net product revenues for Q2 2022, down
13% vs Q2 2021 and down 6% vs Q1 2022
- Reduction in R&D expense of $9.3M or 20% compared to Q2
2021
- Cash used in operating activities down $23.4 million or 40% in
Q2 2022 compared to Q1 2022
- $94.6M in cash and cash equivalents and $9.8M in available
funding under the ATHENA financing at June 30, 2022
Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results
for the quarter ended June 30, 2022, and provided an update on the
Company’s clinical development programs and regulatory and
commercial outlook.
“We achieved a key milestone in the second quarter, with the
presentations of the first clinical data from the LuMIERE trial of
FAP-2286 and from the ongoing imaging-only investigator-initiated
study. In addition to seeing the first evidence of safety and
clinical activity, these initial results further demonstrate that
fibroblast activation protein, or FAP, is a promising theranostic
target with expression across many types of solid tumors,” said
Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Turning
to Rubraca, following the positive results from ATHENA-MONO, we
believe Rubraca represents an important new option as a front-line
maintenance treatment of ovarian cancer, and we are on track for
submissions to the FDA and EMA during the third quarter of 2022.
Lastly, we look forward to the anticipated Phase 3 data readout of
TRITON3 in the second-line prostate cancer treatment setting for
selected patients now expected early in the fourth quarter this
year and ATHENA-COMBO in combination with Opdivo in the front-line
ovarian cancer maintenance treatment setting in the first quarter
of 2023.”
Second Quarter 2022 Financial Results Clovis reported
global net product revenues for Rubraca of $32.1 million for Q2
2022, which included US product revenues of $22.7 million and ex-US
product revenues of $9.4 million. This represents a sequential 6%
decrease over Q1 2022 and a 13% decrease year-over-year, compared
to Q2 2021 net product revenues of $36.8 million, which included US
net product revenues of $27.7 million and ex-US net product
revenues of $9.1 million. The reduction in ovarian cancer diagnoses
and fewer patient starts in the US in previous quarters as a result
of COVID has continued to impact second-line maintenance treatment.
While it does appear that ovarian cancer diagnoses are reverting to
pre-COVID levels, the effect of this increase is almost wholly
observed on front-line treatments and will not likely impact the
second-line indications for several quarters. In addition, we
believe that the adoption of PARP inhibitors in the front-line
setting is impacting the use of PARP inhibitors in the second-line
setting in the US.
Clovis reported net product revenue for Rubraca of $66.4 million
for the six months ended June 30, 2022, which included US product
revenue of $47.2 million and ex-U.S. product revenue of $19.2
million, compared to net product revenue for same period in 2021 of
$74.9 million, which included US net product revenue of $59.4
million and ex-US net product revenue of $15.5 million.
Research and development expenses totaled $36.4 million for Q2
2022, down 20% compared to $45.8 million for the comparable period
in 2021, due primarily to lower spending on Rubraca clinical
trials. For the six months ended June 30, 2022, research and
development expenses totaled $78.7 million, down 20% compared to
$98.6 million for the comparable period in 2021.
Selling, general and administrative expenses totaled $32.6
million for Q2 2022, down 1% compared to $32.9 million for the
comparable period in 2021. For the six months ended June 30, 2022,
SG&A expenses totaled $61.8 million, down 2% compared to $62.9
million for the comparable period in 2021.
Included in Q2 2022 results is a one-time, non-cash adjustment
of $9.7 million in other manufacturing costs related to the
expected expiration of Rubraca currently in inventory. There were
no such costs in Q2 2021.
Clovis reported a net loss for Q2 2022 of $71.3 million, or
($0.50) per share, compared to a net loss for Q2 2021 of $66.4
million, or ($0.61) per share. Net loss for Q2 2022 included
share-based compensation expense of $5.4 million, compared to $7.4
million for the comparable period of 2021.
Clovis had $94.6 million in cash and cash equivalents as of June
30, 2022. As of June 30, 2022, the Company had drawn $165.2 million
under the Sixth Street Partners, LLC (SSP) ATHENA clinical trial
financing and had up to $9.8 million available to draw under the
agreement to fund the expenses of the ATHENA trial.
Based on the Company’s current cash, cash equivalents and
liquidity available under its ATHENA clinical financing agreement,
together with current estimates for revenues generated by sales of
Rubraca, the Company will need to raise additional capital in the
near term in order to fund its operating plan and to continue as a
going concern beyond February of 2023. The proposed reverse stock
split of Clovis common stock, which would have had the effect of
increasing the number of authorized but unissued and unreserved
shares of common stock available for the Company to issue, was not
approved at the Clovis 2022 Annual Meeting of Stockholders.
Although approximately 58% of shares voted supported the proposal,
the affirmative vote of holders of a majority of the issued and
outstanding shares of common stock was necessary for this proposal
to be approved. Without the approval of an increase in authorized
shares of common stock, Clovis is not able to raise meaningful
additional capital through public or private equity-based
offerings. Therefore, the Company is currently exploring
alternatives and strategies to increase the number of shares that
would be available for issuance to permit greater flexibility in
raising capital through equity financing transactions, including
the offer and sale of super-voting mirrored preferred stock that
have been utilized by peers in similar situations to support
approval of such proposals where the existing votes of stockholders
already indicate favorable support.
Clovis is actively exploring sources of funding other than
equity financing transactions, including through entering into
strategic partnerships or licensing arrangements for one or more of
our products or product candidates. Clovis is currently in
preliminary discussions related to partnering certain development
and commercialization rights to FAP-2286, for which the Company
seeks consideration such as an upfront payment and additional
payments in the form of milestones, research and development
support and royalties. However, Clovis cannot be certain that such
efforts will result in a final agreement or that the timing and
amounts of such payments, including contingent payments, would be
sufficient to meet the Company’s liquidity needs in the absence of
other sources of funding. In order to raise sufficient capital to
fund the Company’s operating plan and to continue as going concern
beyond February of 2023, the Company expects it would need to
successfully complete some combination of the strategic initiatives
and equity financing.
Net cash used in operating activities was $35.1 million for Q2
2022, down 25% from the $46.8 million reported in Q2 2021.
Cash burn in Q2 2022 was $26.4 million, down 21% from $33.4
million in Q2 2021, and down 46%, or $22.9 million from the $49.3
million of cash burn reported in Q1 2022. Cash burn for the first
six months of 2022 was $75.6 million, down 7% from $81.5 million in
the first six months of 2021.
Clovis Oncology Pipeline Highlights
Initial Phase 1 FAP-2286 LuMIERE Data Highlighted at SNMMI
2022 Annual Meeting FAP-2286 is the first peptide-targeted
radionuclide therapy (PTRT) and imaging agent targeting fibroblast
activation protein (FAP) to enter clinical development and is the
lead candidate in Clovis Oncology’s targeted radiotherapy (TRT)
development program. The Phase 1 portion of the LuMIERE study, for
which enrollment in the third of four planned dose cohorts is
ongoing, is evaluating the safety of the FAP-targeting
investigational therapeutic agent and will identify the recommended
Phase 2 dose and schedule of lutetium-177 labeled FAP-2286
(177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286)
is being used as an investigational imaging agent to identify
patients with FAP-positive tumors appropriate for treatment in
LuMIERE. Once the Phase 2 dose is determined, Phase 2 expansion
cohorts are planned in multiple tumor types and are expected to
initiate in the fourth quarter of 2022.
Initial FAP-2286 Phase 1 data from LuMIERE were presented in an
oral session at the SNMMI 2022 Annual Meeting in June. Overall, in
nine patients treated in the first two dose cohorts,177Lu-FAP-2286
demonstrated a manageable safety profile and early evidence of
activity, with a confirmed RECIST partial response in one patient
treated at the lowest dose in the trial.
Treatment-emergent adverse events (TEAEs) were found to be
generally mild to moderate among the nine patients in the safety
population receiving 3.7 or 5.55 GBq/dose of the investigational
therapeutic agent 177Lu-FAP-2286.
Also, updated data from the UCSF investigator-initiated Phase 1
study of FAP-2286 labelled with gallium-68 (68Ga-FAP-2286) as a
novel imaging agent to identify metastatic cancer in patients with
solid tumors were presented at ASCO and SNMMI.
Updated LuMIERE data have been accepted as an oral presentation
at the 2022 European Association of Nuclear Medicine (EANM) Annual
Congress on October 17, 2022, in Barcelona, Spain.
Finally, in addition to investigating for therapeutic use
FAP-2286 labeled with the beta particle-emitting lutetium-177,
Clovis is also exploring FAP-2286 labeled with the alpha
particle-emitting actinium-225 (Ac-225), and in June, Clovis
entered a long-term supply agreement with NorthStar Medical
Radioisotopes, LLC, for the therapeutic medical radioisotope,
Ac-225. Under terms of the agreement, NorthStar will provide Clovis
with its high purity non-carrier-added (n.c.a.) Ac-225.
For more information about FAP-2286, TRT, or Clovis’ TRT
development program, click here.
ATHENA-MONO Data Presented at ASCO 2022 and published
in the Journal of Clinical Oncology (JCO) ATHENA is a
double-blind, placebo-controlled, Phase 3 trial of rucaparib in
front-line ovarian cancer maintenance treatment. It has two parts
which are statistically independent. The results presented at ASCO
are from the ATHENA-MONO part (rucaparib versus placebo).
The ATHENA-MONO trial met its primary endpoint, showing Rubraca
monotherapy versus placebo improved progression-free survival (PFS)
by investigator assessment in both populations in the primary
efficacy analyses: HRD-positive and all patients randomized (ITT).
Significant improvement in PFS by BICR assessment, a secondary
endpoint of the study, was also observed in both the HRD-positive
and ITT populations. A benefit in PFS was also seen in the
exploratory subgroup of patients with HRD-negative tumors, those
within the HRD-positive population with either BRCA mutant or BRCA
wild type/loss of heterozygosity (LOH) high tumors and those with
BRCA wild type disease whose LOH status could not be determined,
with results similar for investigator- and BICR-assessment. The
safety of Rubraca observed in ATHENA-MONO was consistent with both
the current US and European labels.
For this indication, Clovis intends to submit a supplemental New
Drug Application (sNDA) to the US Food and Drug Administration and
a Type II variation to the European Medicines Agency (EMA) during
the third quarter of 2022. The FDA has recommended that the Company
wait for more mature overall survival data from ATHENA-MONO to
submit the sNDA or, if it chooses to submit the sNDA prior to
receiving more mature overall survival data, then the sNDA may need
to be discussed at an Oncologic Drugs Advisory Committee (ODAC)
meeting. In addition, the FDA will consider overall survival data
from other rucaparib clinical trials when it reviews the
ATHENA-MONO dataset. The Company believes that the encouraging PFS
results, the primary endpoint of the study, are strongly supportive
of an approval and of use in the front-line setting, and are
grateful for the support of the clinical community familiar with
the results. There can be no assurances regarding the timing or
outcome of the FDA and EMA reviews of the submissions.
Rubraca is not currently approved in the front-line ovarian
cancer maintenance treatment setting.
Two Remaining Rubraca Phase 3 Study Readouts Expected in Next
Three Quarters Top-line data from the ATHENA-COMBO portion of
the ATHENA Phase 3 study in front-line maintenance treatment
ovarian cancer setting evaluating Rubraca plus Opdivo® (nivolumab)
versus Rubraca monotherapy are expected in the first quarter of
2023. The timing for the ATHENA-COMBO Phase 3 data readout is
contingent upon the occurrence of the protocol-specified PFS
events.
Top-line data from the TRITON3 trial, which is the confirmatory
study for Rubraca’s approval in metastatic castration-resistant
prostate cancer (mCRPC) as well as an opportunity for a potential
second-line label expansion, are expected early in the fourth
quarter of 2022. TRITON3 is a Phase 3 study evaluating Rubraca
versus physician’s choice of chemotherapy or second-line androgen
deprivation therapy in patients with mCRPC with BRCA or ATM
mutations with a primary endpoint of radiologic PFS. ATHENA and
TRITON3 each provide the potential to reach larger patient
populations in earlier lines of therapy for both ovarian and
prostate cancers.
Conference Call Details Clovis will hold a conference
call this morning, August 8, at 8:30 am ET, to discuss Q2 2022
results and provide an update on the Company’s clinical development
programs and regulatory and commercial outlook. The conference call
will be simultaneously webcast on the Clovis Oncology website at
clovisoncology.com, and archived for future review. Dial-in numbers
for the conference call are as follows: US participants
888.440.4615, International participants 646.960.0682, conference
ID: 2259685.
About FAP-2286 FAP-2286 is a clinical candidate under
investigation as a peptide-targeted radionuclide therapy (PTRT) and
imaging agent targeting fibroblast activation protein (FAP).
FAP-2286 consists of two functional elements; a targeting peptide
that binds to FAP and a site that can be used to attach radioactive
isotopes for imaging and therapeutic use. High FAP expression has
been shown in pancreatic ductal adenocarcinoma, salivary gland,
mesothelioma, colon, bladder, sarcoma, squamous non-small cell
lung, squamous head and neck cancers, and cancers of unknown
primary. High FAP expression has been detected in both primary and
metastatic tumor samples, independent of tumor stage or grade.
Clovis holds US and global rights for FAP-2286 excluding Europe,
Russia, Turkey, and Israel.
FAP-2286 is an unlicensed medical product.
About Targeted Radionuclide Therapy Targeted radionuclide
therapy is an emerging class of cancer therapeutics, which seeks to
deliver radiation directly to the tumor while minimizing delivery
of radiation to normal tissue. Targeted radionuclides are created
by linking radioactive isotopes, also known as radionuclides, to
targeting molecules (e.g., peptides, antibodies, small molecules)
that can bind specifically to tumor cells or other cells in the
tumor environment. Based on the radioactive isotope selected, the
resulting agent can be used to image and/or treat certain types of
cancer. Agents that can be adapted for both therapeutic and imaging
use are known as “theranostics”. Clovis is developing a pipeline of
novel, targeted radiotherapies for cancer treatment and imaging,
including its lead candidate, FAP-2286, an investigational
peptide-targeted radionuclide therapeutic (PTRT) and imaging agent,
as well as three additional discovery-stage compounds.
About Rubraca (rucaparib) Rubraca is an oral, small
molecule inhibitor of PARP1, PARP2 and PARP3 being developed
multiple tumor types, including ovarian and prostate cancers, as
monotherapy and in combination with other anti-cancer agents.
Exploratory studies in other tumor types are also underway. Clovis
holds worldwide rights for Rubraca.
In the United States, Rubraca is approved for the maintenance
treatment of adult patients with recurrent epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
or partial response to platinum-based chemotherapy. Additionally,
Rubraca is approved in the US for the treatment of adult patients
with a deleterious BRCA mutation (germline and/or
somatic)-associated metastatic castration-resistant prostate cancer
(mCRPC) who have been treated with androgen receptor-directed
therapy and a taxane-based chemotherapy. Select patients for
therapy based on an FDA-approved companion diagnostic for Rubraca.
This indication is approved under accelerated approval based on
objective response rate and duration of response. Continued
approval for this indication may be contingent upon verification
and description of clinical benefit in confirmatory trials. The
TRITON3 clinical trial is expected to serve as the confirmatory
study for the Rubraca accelerated approval in mCRPC.
In Europe, Rubraca is approved for the maintenance treatment of
adults with platinum-sensitive relapsed high-grade epithelial
ovarian, fallopian tube, or primary peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.
Rubraca is also approved in Europe for the treatment of adult
patients with platinum sensitive, relapsed, or progressive, BRCA
mutated (germline and/or somatic), high-grade epithelial ovarian,
fallopian tube, or primary peritoneal cancer, who have been treated
with two or more prior lines of platinum-based chemotherapy, and
who are unable to tolerate further platinum-based chemotherapy.
Rubraca is an unlicensed medical product outside of the US and
Europe.
About the ATHENA Clinical Trial ATHENA
(GOG 3020/ENGOT-ov45) (NCT03522246) is an international,
randomized, double-blind, phase III trial consisting of two
separate and fully independently powered study comparisons
evaluating Rubraca monotherapy (ATHENA-MONO) and Rubraca in
combination with nivolumab (ATHENA-COMBO) as maintenance treatment
for patients with newly diagnosed advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer. ATHENA enrolled
approximately 1000 patients across 24 countries, all women with
newly diagnosed ovarian cancer who responded to their front-line
chemotherapy. The trial completed accrual in 2020 and was conducted
in association with the Gynecologic Oncology Group (GOG) in the US
and the European Network of Gynaecological Oncological Trial groups
(ENGOT) in Europe. GOG and ENGOT are the two largest cooperative
groups in the US and Europe dedicated to the treatment of
gynecological cancers.
ATHENA-MONO is evaluating the benefit of Rubraca monotherapy
versus placebo in 538 women in this patient population. The primary
efficacy analysis evaluated two prospectively defined molecular
sub-groups in a step-down manner: 1) HRD-positive (inclusive of
BRCA mutant) tumors, and 2) the intent-to-treat population, or all
patients treated in ATHENA-MONO.
The ATHENA-COMBO portion of the trial, anticipated to readout in
Q1 2023, is evaluating the magnitude of benefit of adding Opdivo
(nivolumab) to Rubraca monotherapy in the ovarian cancer front-line
maintenance treatment setting. ATHENA-COMBO is anticipated to be
the first Phase 3 dataset to readout evaluating the combination of
a PARP inhibitor and an immune checkpoint inhibitor as maintenance
treatment following completion and response to front-line
chemotherapy.
About Clovis Oncology Clovis Oncology, Inc. is a
biopharmaceutical company focused on acquiring, developing, and
commercializing innovative anti-cancer agents in the US, Europe,
and additional international markets. Clovis Oncology targets
development programs at specific subsets of cancer populations, and
simultaneously develops, with partners, for those indications that
require them, diagnostic tools intended to direct a compound in
development to the population that is most likely to benefit from
its use. Clovis Oncology is headquartered in Boulder, Colorado,
with additional office locations in the US and Europe. Please visit
www.clovisoncology.com for more information.
To the extent that statements contained in this press release
are not descriptions of historical facts regarding Clovis Oncology,
they are forward-looking statements reflecting the current beliefs
and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Examples of forward-looking statements contained in this press
release include, among others, statements regarding our future
financial and operating performance, our need to raise additional
capital to fund our operating plan and to continue as a going
concern, our efforts to seek partners with respect to our products
and product candidates, our business plans or prospects, our
expectations regarding the impact of COVID-19 on our business
operations and results, including future revenues, supply and
distribution of our clinical trial supplies and commercial product
supplies, our expectations regarding our ability to maintain the
enrollment and conduct of our clinical trials and other development
activities, expectations concerning future regulatory activities,
expectations for submission of regulatory filings, our plans to
present final or interim data on ongoing clinical trials, our plans
to submit additional data to, or meet with, the FDA with respect to
the status of or plans for ongoing or planned trials, the timing
and pace of commencement of enrollment in and conduct of our
clinical trials and the cost of certain trials, including those
being considered, planned or conducted in collaboration with
partners, our plans for commencement of additional planned trials,
the potential results of such clinical trials and the potential for
marketing authorizations for new indications, changes in drug
supply timing and costs and other expenses and statements regarding
our expectations of the supply of free drug distributed to eligible
patients and our expectations regarding the funding that may be
available to us under the agreement with Sixth Street Partners,
LLC. Such forward-looking statements involve substantial risks and
uncertainties that could cause our future results, performance, or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, factors that impact our
ability to raise capital, which are outside of our control,
including whether additional funding or partnering transactions
will be available on acceptable terms, or at all, unpredictable
market conditions and volatility in our stock price, our ability to
generate positive data from our clinical studies, and the need for
our stockholders to approve an amendment to our certificate of
incorporation to increase the number of shares of common stock that
we are authorized to issue; the impacts of the COVID-19 pandemic
and disruption related to efforts to mitigate its spread on our
business, results of operations or financial condition, including
impacts on the vendors or distribution channels in our supply
chain, impacts on our contract manufacturers’ ability to continue
to manufacture our products, impacts on our ability to continue our
development activities, impacts on the conduct of our clinical
trials, including with respect to enrollment rates, availability of
investigators and clinical trial sites or monitoring of data and
impact on the ability and timing of our field personnel to conduct
their activities with health care providers, the timing and extent
of recovery from the impact of COVID-19, the uncertainties inherent
in the effect our future revenues or expenses may have on our cash
position, the market potential of our approved drug, including the
performance of our sales and marketing efforts and the success of
competing drugs and therapeutic approaches, changes in gross-to-net
or free drug provided through our patient assistance program, the
availability of reimbursement and insurance coverage, the
performance of our third-party manufacturers, whether our clinical
development programs for our drug candidates and those of our
partners can be completed on time or at all, whether future study
results will be consistent with study findings to date and whether
future study results will support continued development or
regulatory approval, the corresponding development pathways of our
companion diagnostics, the timing of availability of data from our
clinical trials and the results, the initiation, enrollment, timing
and results of our planned clinical trials, the risk that final
results of ongoing trials may differ from initial or interim
results as a result of factors such as final results from a larger
patient population may be different from initial or interim results
from a smaller patient population, actions by the FDA, the EMA or
other regulatory authorities regarding data required to support
drug applications and whether to accept or approve drug
applications that may be filed, their interpretations of our data
and agreement with our regulatory approval strategies or components
of our filings, including our clinical trial designs, conduct and
methodologies, as well as their decisions regarding drug labeling,
reimbursement and pricing, and other matters that could affect the
development, approval, availability or commercial potential of our
drug candidates or companion diagnostics. Clovis Oncology does not
undertake to update or revise any forward-looking statements. A
further description of risks and uncertainties can be found in
Clovis Oncology’s filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K and its
reports on Form 10-Q and Form 8-K.
CLOVIS ONCOLOGY, INC. CONSOLIDATED FINANCIAL RESULTS
(Unaudited, in thousands, except per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Revenues:
Product revenue
$
32,143
$
36,820
$
66,390
$
74,873
Operating expenses:
Cost of sales - product
7,872
8,294
15,942
16,562
Cost of sales - intangible asset amortization
1,343
1,343
2,686
2,686
Research and development
36,426
45,759
78,676
98,564
Selling, general and administrative
32,590
32,918
61,803
62,859
Acquired in-process research and development
-
2,204
-
2,204
Other operating expenses
13,293
3,884
17,023
7,591
Total expenses
91,524
94,402
176,130
190,466
Operating loss
(59,381
)
(57,582
)
(109,740
)
(115,593
)
Other income (expense):
Interest expense
(9,674
)
(8,770
)
(18,774
)
(16,807
)
Foreign currency loss
(2,489
)
(206
)
(3,468
)
(752
)
Other income
171
107
320
290
Other income (expense), net
(11,992
)
(8,869
)
(21,922
)
(17,269
)
Loss before income taxes
(71,373
)
(66,451
)
(131,662
)
(132,862
)
Income tax benefit
41
3
162
137
Net loss
$
(71,332
)
$
(66,448
)
$
(131,500
)
$
(132,725
)
Basic and diluted net loss per common share
$
(0.50
)
$
(0.61
)
$
(0.93
)
$
(1.25
)
Basic and diluted weighted-average common shares
144,036
108,481
141,137
106,375
CONSOLIDATED BALANCE SHEET DATA (In thousands)
June 30, 2022
(Unaudited)
Dec 31, 2021
Cash and cash equivalents
$
94,579
$
143,428
Working capital
21,012
72,873
Total assets
392,856
472,833
Convertible senior notes
437,800
436,772
Common stock and additional paid-in capital
2,682,894
2,641,841
Total stockholders' deficit
(367,695
)
(278,840
)
Other Data (Unaudited, in thousands)
Six Months Ended June
30,
2022
2021
Net cash used in operating activities
$
(93,622
)
$
(108,645
)
Share Based Compensation Expense
$
12,034
$
11,401
RECONCILIATION OF NET CASH USED IN OPERATING
ACTIVITIES TO CASH BURN (Unaudited, in thousands)
Three Months Ended June
30,
Six Months Ended June
30,
2022
2021
2022
2021
Net cash used in operating activities
$
(35,127
)
$
(46,755
)
$
(93,622
)
$
(108,645
)
Adjustments:
Proceeds from borrowings under financing agreement
8,760
13,351
17,981
27,154
Cash burn
$
(26,367
)
$
(33,404
)
$
(75,641
)
$
(81,491
)
Net cash used in investing activities
$
(46
)
$
(36
)
$
(108
)
$
(154
)
Net cash provided by financing activities
$
9,144
$
85,940
$
47,001
$
99,316
Three Months Ended March
31,
2022
Net cash used in operating activities
$
(58,495
)
Adjustments:
Proceeds from borrowings under financing agreement
9,221
Cash burn
$
(49,274
)
Net cash used in investing activities
$
(62
)
Net cash provided by financing activities
$
37,857
To supplement our financial statements prepared in
accordance with U. S. GAAP, we monitor and consider cash burn,
which is a non-U.S. GAAP financial measure. This non-U.S. GAAP
financial measure is not based on any standardized methodology
prescribed by U.S. GAAP and is not necessarily comparable to
similarly-titled measures presented by other companies. We define
cash burn as net cash used in operating activities less proceeds
from borrowings under financing agreement with Sixth Street
specifically related to our Phase 3 ATHENA trial. We believe cash
burn to be a liquidity measure that provides useful information to
management and investors about the amount of cash consumed by the
operations of the business including proceeds from borrowings under
the Sixth Street financing agreement, which specifically offsets
the costs of our ATHENA trial. A limitation of using this non-U.S.
GAAP measure is that cash burn does not represent the total change
in cash and cash equivalents for the period because it excludes all
other cash provided by or used for other investing and financing
activities. We account for this limitation by providing information
about our investing and financing activities in the statements of
cash flows in our financial statements and by presenting cash flows
from investing and financing activities in our reconciliation of
cash burn. In addition, it is important to note that other
companies, including companies in our industry, may not use cash
burn, may calculate cash burn in a different manner than we do or
may use other financial measures to evaluate their performance, all
of which could reduce the usefulness of cash burn as a comparative
measure. Because of these limitations, cash burn should not be
considered in isolation from, or as a substitute for, financial
information prepared in accordance with U.S. GAAP.
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version on businesswire.com: https://www.businesswire.com/news/home/20220808005183/en/
Breanna Burkart (303) 625-5023 bburkart@clovisoncology.com Anna
Sussman (303) 625-5022 asussman@clovisoncology.com
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