On august 1, 2018 United Therapeutics Corporation (NASDAQ: UTHR) reported its financial results for the quarter ended June 30, 2018 (Press release, United Therapeutics, AUG 1, 2018, View Source [SID1234528401]).

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"Our second quarter net revenues totaled $444 million and we are treating a larger number of patients, compared to the prior year, suffering from pulmonary arterial hypertension with our prostacyclin product franchise, which consists of Orenitram, Remodulin, and Tyvaso," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "We also continued to invest in our innovative product pipeline, which includes seven Phase III clinical trials in cardiopulmonary diseases and oncology as well as programs in regenerative medicine and organ manufacturing to ultimately provide a cure for PAH and other end-stage organ diseases. We believe this product pipeline uniquely positions United Therapeutics to deliver long-term revenue growth to our stakeholders."

Update on SteadyMed Acquisition

Our previously-announced acquisition of SteadyMed Ltd. (SteadyMed) has satisfied two key closing conditions. On July 20, 2018, the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 expired, and on July 30, 2018, SteadyMed’s shareholders approved the transaction. Under Israeli law, closing may not occur until at least thirty days have passed since the SteadyMed shareholders approved the transaction. Assuming all remaining conditions to closing of this transaction are satisfied or waived, we expect the transaction to be completed in the third quarter of this year. SteadyMed’s lead drug product candidate is Trevyent, a development-stage drug-device combination product that combines SteadyMed’s PatchPump technology with treprostinil to treat pulmonary arterial hypertension.

Financial Results for the Three Months Ended June 30, 2018 compared to the Three Months Ended June 30, 2017

Key financial highlights include (dollars in millions, except per share data):

Three Months Ended
June 30,

Dollar

Percentage

2018

2017

Change

Change

Revenues

$

444.5

$

444.6

$

(0.1)

—

%

Net income (loss)

$

172.9

$

(56.0)

$

228.9

409

%

Non-GAAP earnings(1)

$

189.1

$

199.2

$

(10.1)

(5)

%

Net income (loss), per basic share

$

4.01

$

(1.25)

$

5.26

421

%

Net income (loss), per diluted share

$

3.98

$

(1.25)

$

5.23

418

%

Non-GAAP earnings, per diluted share(1)

$

4.36

$

4.37

$

(0.01)

—

%

(1)

See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below.

Revenues

The following table presents the components of total revenues (dollars in millions):

Three Months Ended
June 30,

Dollar

Percentage

2018

2017

Change

Change

Net product sales:

Remodulin

$

159.5

$

157.7

$

1.8

1

%

Tyvaso

105.9

104.2

1.7

2

%

Adcirca

109.8

120.6

(10.8)

(9)

%

Orenitram

49.5

46.0

3.5

8

%

Unituxin

19.8

16.1

3.7

23

%

Total revenues

$

444.5

$

444.6

$

(0.1)

—

%

Revenues for the three months ended June 30, 2018 decreased by $0.1 million as compared to the same period in 2017. Remodulin net product sales increased by $1.8 million due to a $16.7 million increase in U.S. net product sales partially offset by a $14.9 million decrease in international net product sales. U.S. net product sales increased due to an increase in quantities ordered from our U.S. distributors, which do not precisely reflect underlying patient demand, and a price increase implemented in April 2018, which was the first price increase for Remodulin since 2010. International net product sales decreased primarily due to a reduction in the price at which we sell Remodulin to an international distributor in connection with a transfer of additional regulatory and commercial responsibilities to that distributor in 2017. Tyvaso net product sales increased by $1.7 million primarily due to a price increase. Adcirca net product sales decreased by $10.8 million primarily due to a decrease in the number of bottles sold, partially offset by price increases that were determined by Lilly. Orenitram net product sales increased by $3.5 million primarily due to an increase in the number of patients being treated with Orenitram. Unituxin net product sales increased by $3.7 million primarily due to an increase in the number of vials sold and a price increase implemented in 2017.

Expenses

Cost of product sales. The following table summarizes cost of product sales by major category (dollars in millions):

Three Months Ended
June 30,

Dollar

Percentage

2018

2017

Change

Change

Category:

Cost of product sales

$

61.1

$

19.3

$

41.8

217

%

Share-based compensation expense (benefit)(1)

0.6

(0.4)

1.0

250

%

Total cost of product sales

$

61.7

$

18.9

$

42.8

226

%

(1)

Refer to Share-based compensation expense (benefit) below for discussion.

Cost of product sales, excluding share-based compensation. The increase in cost of product sales of $41.8 million for the three months ended June 30, 2018, as compared to the same period in 2017, was primarily due to a $40.7 million increase in the royalty expense for Adcirca. As a result of an amendment to our license agreement with Lilly, effective December 1, 2017 our royalty rate on net product sales of Adcirca increased from five percent to an effective rate of approximately 42.5 percent.

Research and development expense. The following table summarizes research and development expense by major category (dollars in millions):

Three Months Ended
June 30,

Dollar

Percentage

2018

2017

Change

Change

Category:

Research and development projects

$

79.1

$

61.6

$

17.5

28

%

Share-based compensation expense (benefit)(1)

3.2

(1.8)

5.0

278

%

Total research and development expense

$

82.3

$

59.8

$

22.5

38

%

(1)

Refer to Share-based compensation expense (benefit) below for discussion.

Research and development expense, excluding share-based compensation. The increase in research and development expense of $17.5 million for the three months ended June 30, 2018, as compared to the same period in 2017, was driven by the continued investment in our innovative product pipeline to treat cardiopulmonary diseases and cancer.

Selling, general and administrative expense. The following table summarizes selling, general and administrative expense by major category (dollars in millions):

Three Months Ended
June 30,

Dollar

Percentage

2018

2017

Change

Change

Category:

General and administrative

$

50.8

$

51.6

$

(0.8)

(2)

%

Sales and marketing

15.6

15.5

0.1

1

%

Share-based compensation expense(1)

16.7

0.3

16.4

NM

(2)

Total selling, general and administrative expense

$

83.1

$

67.4

$

15.7

23

%

(1)

Refer to Share-based compensation expense (benefit) below for discussion.

(2)

Calculation is not meaningful.

Share-based compensation expense (benefit). The following table summarizes share-based compensation (benefit) expense by major category (dollars in millions):

Three Months Ended
June 30,

Dollar

Percentage

2018

2017

Change

Change

Category:

Stock options

$

15.5

$

12.2

$

3.3

27

%

Restricted stock units

2.0

0.5

1.5

300

%

Share tracking awards plan (STAP)

2.7

(14.9)

17.6

118

%

Employee stock purchase plan

0.3

0.3

—

—

%

Total share-based compensation expense (benefit)

$

20.5

$

(1.9)

$

22.4

NM

(1)

(1)

Calculation is not meaningful.

The increase in share-based compensation expense of $22.4 million for the three months ended June 30, 2018, as compared to the same period in 2017, was primarily due to: (1) a $17.6 million increase in STAP expense related to an increase in our stock price during the three months ended June 30, 2018, as compared to a decrease in our stock price during the same period in 2017; and (2) a $3.3 million increase in stock option expense due to additional awards granted and outstanding in 2018.

Loss Contingency

In December 2017, we entered into a civil Settlement Agreement with the U.S. Government to resolve a DOJ investigation related to our support of 501(c)(3) organizations that provide financial assistance to patients. During the second quarter of 2017, we recorded a $210.0 million accrual relating to this matter, and ultimately paid this amount, plus interest, to the U.S. Government upon settlement.

Impairment of Investment in a Privately-Held Company

During the quarter ended June 30, 2017, one of our investments in a privately-held company experienced an event triggering an impairment analysis to evaluate the recoverability of our investment. We determined that the fair value of our investment as of June 30, 2017 was lower than its carrying value, resulting in an impairment charge of $46.5 million. As of June 30, 2017, the adjusted carrying value of our investment in this company was $53.5 million. The carrying value of this asset has not been further adjusted since June 30, 2017.

Income Tax Expense

The provision for income taxes was $45.0 million for the three months ended June 30, 2018, as compared to $100.2 million for the same period in 2017. The provision for income taxes is based on an estimated effective tax rate for the entire year. The estimated annual effective tax rate is subject to adjustment in subsequent quarterly periods if components used to estimate the annual effective tax rate are updated or revised. Our effective tax rate (ETR) as of June 30, 2018 and June 30, 2017 was approximately 21 percent and approximately 60 percent, respectively. Our ETR for the six months ended June 30, 2018 decreased as compared to the same period in 2017 due to the impacts of The Tax Cuts and Jobs Act as well as the $210.0 million accrual in connection with the civil settlement described above and the $46.5 million impairment charge described above that did not meet the criteria for tax deductibility at that time.

On August 1, 2018 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the second quarter ended June 30, 2018 (Press release, Compugen, AUG 1, 2018, View Source [SID1234528284]).

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"The first half of 2018 has been transformational for Compugen, and we are excited to soon dose the first patient in the Phase 1 clinical trials for COM701, our lead cancer immunotherapy program," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "COM701 is a first-in-class therapeutic antibody targeting PVRIG, a novel immune checkpoint originating from Compugen’s computational discovery efforts. Based on the mechanistic rationale for this newly-discovered checkpoint pathway, which ties into both the TIGIT and PD‑1 pathways, COM701 has the potential to improve the response rate in patients with refractory or relapsed disease following treatment with existing cancer immunotherapies in multiple solid tumor indications. As we believe we have the only clinical-stage product candidate targeting PVRIG, which is part of the larger TIGIT/PVRIG and PD-1 axis, Compugen has a first-mover advantage in the competitive cancer immunotherapy landscape."

"COM701 and BAY 1905254, which are both initiating Phase 1 clinical trials in 2018, represent a key milestone for our Company. These two clinical-stage programs, along with our anti-TIGIT antibody, COM902, address new immune checkpoints that were identified purely through computational analysis. Compugen is a pioneer and leader in computational discovery, a field now receiving increasing attention in our industry. Our proven know-how in computational discovery, coupled with our integrated in-house drug development capabilities, uniquely position us in this field. We will continue to employ this core competency to generate novel drug targets and therapeutic programs for internal development and for collaboration purposes," added Dr. Cohen-Dayag.

Paul Sekhri, Chairman of the Board, stated, "We are very pleased with Compugen’s accomplishments to date in 2018 and excited about the future prospects of the Company. In parallel with this progress, we recently added three new members to the Board of Directors, whom together with the existing members, have the breadth of experience and expertise to support and guide the Company’s future growth. Along with our strong management team, I am confident in our ability to execute our long-term strategy, continue advancing our therapeutic pipeline and achieve our corporate business goals."

Recent highlights:

Investigational new drug (IND) application for COM701, a first-in-class therapeutic antibody targeting PVRIG, cleared by the U.S. Food and Drug Administration (FDA). First patient dosing in Phase 1 study for COM701 expected in early fall 2018.
IND application for BAY 1905254, a first-in-class therapeutic antibody targeting ILDR2 being developed under license by Bayer AG, cleared by the FDA. First patient dosing in Phase 1 study for BAY 1905254 expected in 2018 and will trigger a milestone payment to Compugen.
A registered direct offering with net proceeds of approximately $19.8 million concluded.
Three new board members appointed to the Company’s Board of Directors.
Financial Results

R&D expenses for the second quarter ended June 30, 2018, were $8.0 million, compared with $7.1 million for the comparable period in 2017. The increase in R&D expenses reflects preclinical development activities as well as expenses associated with clinical-related activities in preparation for the COM701 Phase 1 trial expected to begin later this year.

Net loss for the second quarter of 2018 was $10.2 million, or $0.19 per diluted share, compared with a net loss of $9.2 million, or $0.18 per diluted share, in the comparable period of 2017.

As of June 30, 2018, cash, cash related accounts, short-term and long-term bank deposits totaled $43.1 million, compared with $30.4 million at December 31, 2017. During the second quarter, the Company completed a registered direct offering with net proceeds of approximately $19.8 million. The Company has no debt.

Conference Call and Webcast Information

Compugen will hold a conference call to discuss its second quarter 2018 results today, August 1, 2018, at 8:30 a.m. ET. To access the live conference call by telephone, please dial 1-888-668-9141 from the U.S., or +972-3-918-0609 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. In its prepared comments, management will refer to the slide found in this link. Following the live audio webcast, a replay will be available on the Company’s website (www.cgen.com).

On August 1, 2018 Xcovery, a developer of targeted therapeutics for cancer, reported that the first cohort of patients has been enrolled to the Phase 1/2 clinical trial evaluating the safety and efficacy of the combination of vorolanib (X-82) and nivolumab (Opdivo) for the treatment of non-small cell lung cancer (NSCLC) or thymic carcinoma (Press release, Xcovery, AUG 1, 2018, View Source [SID1234528300]). Vorolanib is Xcovery’s proprietary next-generation vascular endothelial growth factor receptor (VEGFR) kinase inhibitor, while nivolumab is the first approved anti-PD-1 monoclonal antibody, developed by Bristol-Myers Squibb. This investigator-initiated trial is led by Dr. Leora Horn of the Vanderbilt-Ingram Cancer Center.

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"The initiation of this trial is a significant milestone as we move forward in our mission to advance the treatment of cancer by developing therapeutics that reduce side effects and optimize the efficacy of cancer treatments for patients," said Lieming Ding, M.D., Chairman of Xcovery. "We look forward to its initial results."

The Phase 1/2 open label study is designed to assess the safety and response rate of vorolanib when administered in combination with nivolumab. Refractory patients with NSCLC naïve to checkpoint inhibitor therapy, NSCLC who have progressed on checkpoint inhibitor therapy, or thymic carcinoma will be enrolled. Nivolumab is the first approved drug in the class of checkpoint inhibitors that have demonstrated significant benefits to many cancer patients in recent years. It works by activating the patient’s own immune system to attack the tumor. Vorolanib may modulate the tumor microenvironment and potentiate the efficacy of checkpoint inhibitors such as nivolumab.

"Despite the success of checkpoint inhibitors, there is a need for new treatment modalities to expand the patient population who would benefit from these immunotherapies and/or to overcome resistance to immunotherapies," said Leora Horn, M.D., Associate Professor of Medicine, Director Thoracic Oncology Research Program and Assistant Vice Chairman for Faculty Development at Vanderbilt University. "The vorolanib combination with nivolumab could be an interesting option."

For more information on the vorolanib (X-82) combination trial, please visit ClinicalTrials.gov. (Identifier: NCT03583086).

About Vorolanib
Vorolanib is a next generation VEGFR inhibitor. It was designed to have reduced toxicities for combination use. Vorolanib is being studied in advanced solid tumors including non-small cell lung cancer, thoracic tumors, renal cell carcinoma, and melanoma.

On August 1, 2018 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has initiated a Phase 1/2a clinical study for AGI-134, a novel compound that evokes a direct anti-tumor response, as well as a vaccine effect, via a unique, universally applicable, multi-arm mechanism that targets patient-specific tumor neoantigens (Press release, BioLineRx, AUG 1, 2018, View Source;itemid=617 [SID1234528285]).

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AGI-134 is a synthetic, intratumorally administered glycolipid designed to label cancer cells with alpha-Gal, which then become the target of pre-existing anti-Gal antibodies, effectively triggering an immediate local anti-tumor response, as well as a follow-on systemic anti-tumor response targeting both the primary injected tumor and distal secondary tumors.

The Phase 1/2a study is a multicenter, open-label study that will take place in the UK and Israel, with possible expansion to the US and additional countries in Europe in 2019. The study is primarily designed to evaluate the safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in unresectable metastatic solid tumors. Additional objectives are to perform a wide array of biomarker studies and to demonstrate the mechanism of AGI-134. Furthermore, efficacy will be assessed by clinical and pharmacodynamic parameters.

The study will be comprised of two parts: (i) an accelerated dose-escalation part to assess the safety and tolerability of intratumorally injected AGI-134 as a monotherapy, as well as to determine the maximum tolerated dose and the recommended dose for part 2 of the study; and (ii) a dose expansion part at the recommended dose, comprised of three cohorts and designed to assess the safety, tolerability and anti-tumor activity of AGI-134 as a monotherapy in a basket cohort of multiple solid tumor types, as well as in two additional cohorts in combination with an immune checkpoint inhibitor – in metastatic colorectal cancer and head and neck squamous cell carcinoma.

Prof. Mark Middleton of the University of Oxford, the study’s principal investigator, stated, "We are very excited to be launching a first-in-human clinical trial assessing AGI-134 for the treatment of solid tumors. AGI-134 represents a new mechanistic class of cancer immunotherapies, with a unique and highly differentiated mode of action, harnessing pre-existing immune machinery to trigger a systemic anti-tumor response and create a pro-inflammatory tumor microenvironment. More treatment options are urgently needed for cancer patients and we are optimistic that AGI-134’s encouraging pre-clinical results are going to translate to an efficacious and safe treatment for humans."

"We are pleased to enter the clinic with our second lead oncology project," said Philip Serlin, Chief Executive Officer of BioLineRx. "Numerous pre-clinical studies to date have demonstrated that treatment with AGI-134 leads to regression of established primary tumors, prevents growth of untreated distal secondary tumors, and triggers a vaccine effect that may prevent the development of future metastases. Furthermore, a combination of AGI-134 and an anti-PD-1 immune checkpoint inhibitor has demonstrated synergistic effect in protection from secondary tumor growth. We look forward to the first results of the Phase 1/2a study expected by the end of 2020."

About AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intratumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has completed numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On August 1, 2018 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended June 30, 2018, and provided an update on the Company’s clinical development programs and regulatory and commercial outlook for the second half of 2018 (Press release, Clovis Oncology, AUG 1, 2018, View Source [SID1234528301]).

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"We are pleased with the launch of Rubraca in the broader maintenance indication in the U.S. and are preparing for the planned launch in the EU early next year," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "We look forward to the presentation of the initial data for rucaparib in patients with germline or somatic BRCA mutation-positive metastatic castrate-resistant prostate cancer at ESMO (Free ESMO Whitepaper) in October, and we are actively advancing multiple combination studies for each of rucaparib and lucitanib."

Second Quarter 2018 Financial Results

Clovis reported net product revenue for Rubraca of $23.8 million for the second quarter of 2018 following the label expansion to include the earlier-line and all-comers ovarian cancer maintenance treatment indication on April 6. The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for the three months ended June 30, 2018 was an additional approximately 25 percent of the overall commercial supply, or the equivalent of $7.9 million in commercial value. In the six months ended June 30, 2018, the supply of this free drug was an additional approximately 24 percent of the overall commercial supply, or the equivalent of $13.4 million in commercial value. The Company expects the free product percentage to continue in the mid to high 20-percent range for the remainder of 2018. Net product revenue for the first quarter of 2018 was $18.5 million, for a total of $42.3 million for the first six months of 2018. Net product revenue for the quarter and first half ended June 30, 2017 was $14.6 million and $21.7 million, following the initial approval and launch of Rubraca in the treatment setting on December 19, 2016.

Clovis had $682.2 million in cash, cash equivalents and available-for-sale securities as of June 30, 2018. Cash used in operating activities was $110.2 million for the second quarter of 2018 and $210.8 million for the first half of 2018, compared with $69.1 million for the second quarter of 2017 and $149.5 million for the first half of 2017. This includes product supply costs of $44.6 million in the second quarter of 2018 and $76.1 million in the first half of 2018 related to Clovis’ previously-described plan to build additional inventory in advance of the transition to a new manufacturing facility for Rubraca. Product supply costs are expected to be approximately $10 million for the remainder of 2018. The Company also expects to incur final capital costs for the new manufacturing facility of approximately $8 million in late 2018. Additionally, and also as previously described, Clovis made one-time milestone payments to Pfizer of $58 million in the second quarter of 2018 related to U.S. product approvals in December 2016 and April 2018 and European product approval in May 2018.

Clovis reported a net loss for the second quarter of 2018 of $101.2 million, or ($1.94) per share, and $178.9 million, or a net loss of ($3.48) per share for the first half of 2018. Net loss was $175.4 million, or a net loss of ($3.88) per share for the second quarter of 2017, and $233.8 million, or a net loss of ($5.24) per share for the first half of 2017.

During the second quarter of 2018, Clovis recorded a one-time charge of $20.0 million related to an agreement in principle reached with the S.E.C. that, if approved by the S.E.C. and the U.S. District Court where the settlement is to be filed, would resolve the S.E.C.’s investigation related to rociletinib.

Additionally, the net loss for the six months ended June 30, 2018 also includes a charge of $8.0 million in the first quarter related to a legal settlement. The net loss for the quarter and six months ended June 30, 2017 included a charge of $117.0 million related to a legal settlement.

The adjusted net loss excluding these items was $81.2 million, or ($1.55) per share for the second quarter, and $150.9 million, or ($2.93) per share for the first half of 2018, compared to an adjusted net loss of $58.4 million, or ($1.29) per share for the second quarter, and $116.8 million, or ($2.62) per share for the first half of 2017. Net loss for the second quarter and first half of 2018 included share-based compensation expense of $14.9 million and $26.8 million, compared to $10.7 million and $19.6 million for the comparable periods of 2017.

Clovis had approximately 52.6 million shares of common stock outstanding as of June 30, 2018.

Research and development expenses totaled $52.7 million for the second quarter of 2018 and $96.3 million for the first half of 2018, compared to $33.1 million and $65.6 million for the comparable periods in 2017. Research and development expenses will continue to increase compared to last year as planned Rubraca studies progress.

Selling, general and administrative expenses totaled $44.9 million for the second quarter of 2018 and $84.1 million for the first half of 2018, compared to $36.1 million and $65.4 million for the comparable periods in 2017. Selling, general and administrative expenses will continue to increase compared to last year in support of administrative and commercial activities related to Rubraca in the United States and Europe.

Key Milestones and Objectives for Rubraca

U.S. Approval for Ovarian Cancer Maintenance Treatment Indication

On April 6, the U.S. Food and Drug Administration (FDA) approved Rubraca (rucaparib) tablets 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. FDA granted regular approval for Rubraca in this second, broader and earlier-line indication on a priority review timeline based on positive data from the phase 3 ARIEL3 clinical trial. Biomarker testing is not required for patients to be prescribed Rubraca in this maintenance treatment indication. In addition to granting Rubraca approval in this second indication, the FDA converted the approval of the initial treatment indication from an accelerated to a regular approval.

European Union (EU) Authorization Granted for Recurrent Ovarian Cancer Treatment Indication and Maintenance Treatment Variation Under Review

In late May, the Company announced that the European Commission authorized Rubraca as monotherapy 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.

Following the receipt of the initial Marketing Authorization for Rubraca, Clovis submitted a variation to include the maintenance indication, which was validated by the European Medicines Agency (EMA) in early July. The review is underway and an opinion for the maintenance indication from the Committee for Medicinal Products for Human Use (CHMP) is anticipated by the end of 2018. Clovis continues to establish its EU organization to support the planned launch of Rubraca in Europe.

Rubraca Clinical Development

Clovis has a robust clinical development program underway in multiple tumor types, including Clovis-sponsored, partner-sponsored and investigator-initiated trials. The following clinical studies are open for enrollment or are anticipated to open during the next several months:

The Clovis-sponsored ARIEL4 confirmatory study in the treatment setting is a Phase 3 multicenter, randomized study of Rubraca versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations who have failed two prior lines of therapy. This study is currently enrolling patients.
The Clovis-sponsored Phase 3 ATHENA study in advanced ovarian cancer in the first-line maintenance treatment setting evaluating Rubraca plus Opdivo (PD-1 inhibitor), Rubraca, Opdivo and placebo in newly-diagnosed patients who have completed platinum-based chemotherapy. This study, as part of a broad clinical collaboration with Bristol-Myers Squibb, is currently open for enrollment.
The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in metastatic castration-resistant prostate cancer (mCRPC) enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on androgen-receptor (AR)-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting. TRITON3 compares Rubraca to physician’s choice of AR-targeted therapy or chemotherapy in these patients. This study is currently enrolling patients.
The Clovis-sponsored TRITON2 study in mCRPC, a Phase 2 single-arm study in patients with BRCA mutations (inclusive of germline and somatic) and also enrolling patients with deleterious mutations of other homologous recombination (HR) repair genes, including ATM. All patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of AR-targeted therapy. This study is currently enrolling patients. The Company plans to present initial data from the ongoing TRITON2 study in a poster discussion session and host an investor/analyst event at ESMO (Free ESMO Whitepaper) on Sunday, October 21, 2018.
The Clovis-sponsored single-arm Phase 2 open-label monotherapy study of Rubraca in recurrent, metastatic bladder cancer titled ATLAS: A Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma. This study is currently enrolling patients.
The Phase 1 RUCA-J study, sponsored by Clovis, is a Phase 1 study to identify the recommended dose of rucaparib in Japanese patients, which will enable development of a bridging strategy and potential inclusion of Japanese sites in planned or ongoing global studies. This study is currently enrolling patients.
The Phase 2, open-label, multi-cohort study evaluating the combination of Rubraca and Opdivo in patients with relapsed, BRCA wild-type ovarian cancer and in patients with locally advanced or metastatic bladder carcinoma. This study is sponsored by Clovis and is expected to begin in the second half of 2018.
The Phase 3 pivotal study in advanced triple-negative breast cancer (TNBC) to evaluate Opdivo and Rubraca in combination. This study is sponsored by Bristol-Myers Squibb.
The Phase 2 combination study of Opdivo with Rubraca for the treatment of mCRPC. This study, sponsored by Bristol-Myers Squibb, is being conducted as an arm of a larger sponsored prostate cancer study. This study is currently enrolling patients.
The Phase 1b combination study of the cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and Rubraca for the treatment of ovarian and triple-negative breast cancers. This study is sponsored by Roche and is currently enrolling patients.
Exploratory studies in other tumor types are also underway.

Additionally, in June, the Company announced a planned clinical collaboration with Immunomedics to evaluate the combination of Rubraca and sacituzumab govitecan as a treatment for advanced metastatic triple-negative breast and metastatic urothelial cancers.

Lucitanib Clinical Development

Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3), platelet-derived growth factor receptors alpha and beta (PDGFRα/β) and fibroblast growth factor receptors 1 through 3 (FGFR1-3), which was previously evaluated in breast and lung cancers in partnership with Servier. Clovis has received notice from Servier that they will return their ex-US rights (excluding China) for lucitanib later in 2018. Clovis therefore will own global rights (excluding China) to lucitanib. There are no payments from Clovis to Servier related to the return of these ex-US rights.

Lucitanib was originally developed by Clovis and Servier with the hypothesis of activity in FGFR driven tumors; data in breast and lung cancer were insufficient to move the program forward. Recent data for a similar drug that inhibits these same three pathways – when combined with a PD-1 inhibitor – are extremely encouraging and represent a validated and alternative hypothesis for the development of lucitanib in combination with a PD-(L)1 inhibitor, and a Clovis-sponsored combination study is now being planned. Clovis also intends to initiate a study of lucitanib in combination with rucaparib, based on encouraging data of VEGF and PARP inhibitors in combination. Each of these studies is expected to initiate before the end of Q1 2019.

Conference Call Details

Clovis will hold a conference call to discuss Q2 2018 results this afternoon, August 1, at 4:30pm ET. The conference call will be simultaneously webcast on the Company’s web site at www.clovisoncology.com, and archived for future review. Dial-in numbers for the conference call are as follows: US participants 866.489.9022, International participants 678.509.7575, conference ID: 9289064.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. 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. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S. and EU.