On February 20, 2020 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its results for the quarter ended December 31, 2019 (Press release, Corcept Therapeutics, FEB 20, 2020, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-2 [SID1234554559]).

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Financial Highlights

2019 revenue of $306.5 million, an increase of 22 percent from 2018
Fourth quarter revenue of $87.9 million, an increase of 32 percent from fourth quarter 2018
Fully diluted 2019 GAAP net income of $0.77 per share, compared to $0.60 in 2018
Fully diluted fourth quarter GAAP net income of $0.24 per share, compared to $0.18 in 2018
Year-end cash and investments of $315.3 million, compared to $206.8 million at year-end 2018
Reiterated 2020 revenue guidance of $355 – 375 million
Financial Results

Corcept’s 2019 revenue was $306.5 million, compared to $251.2 million in 2018. Fourth quarter revenue was $87.9 million, compared to $66.8 million in the fourth quarter of 2018. The company reiterated its 2020 revenue guidance of $355 – 375 million.

GAAP net income was $94.2 million for the year and $29.4 million in the fourth quarter of 2019, compared to $75.4 million for the year and $22.0 million in the fourth quarter of 2018.

Excluding non-cash expenses related to stock-based compensation and the utilization of deferred tax assets, together with related income tax effects, non-GAAP net income was $40.3 million in the fourth quarter, compared to $30.4 million in the fourth quarter of 2018. For the full-year, non-GAAP net income was $133.3 million, compared to $108.2 million in 2018. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments increased by $48.4 million in the fourth quarter, to $315.3 million.

"Our Cushing’s syndrome business had an excellent 2019," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer, "and we expect growth to continue in 2020, as more patients with Cushing’s syndrome receive Korlym and the number of first-time and repeat prescribers of the medication continues to increase.

"Our commercial success has given us the financial resources to advance our portfolio of selective cortisol modulators. By year-end, we plan to be testing three of our proprietary compounds in Phase 2 or Phase 3 trials in Cushing’s syndrome, ovarian cancer, pancreatic cancer, adrenal cancer, antipsychotic-induced weight gain (APIWG) and non-alcoholic steatohepatitis (NASH)."

Cushing’s Syndrome

Phase 3 trial (GRACE) of relacorilant to treat patients with Cushing’s syndrome actively enrolling patients at sites in the United States, Europe and Israel
Phase 3 trial (GRADIENT) of relacorilant to treat patients with Cushing’s syndrome caused by adrenal adenomas expected to start in first quarter
"GRACE is open at fifty-four clinical sites," said Andreas Grauer, MD, Corcept’s Chief Medical Officer. "Our investigators are enthusiastic. Patients in relacorilant’s Phase 2 trial exhibited meaningful improvements in glucose control and hypertension – two of Cushing’s syndrome’s most pernicious manifestations – as well as in important secondary endpoints, without instances of Korlym’s significant off-target effects – vaginal bleeding, endometrial thickening and low potassium.1 For these physicians, whose patients have few good treatment options, the prospect of confirming these data in a pivotal trial is exciting. As we have said, we plan to complete GRACE in time to submit our NDA in the fourth quarter of 2021.

"Our preparations for opening a double-blind, placebo-controlled, Phase 3 trial (GRADIENT) in patients with Cushing’s syndrome caused by adrenal adenomas are nearly complete," added Dr. Grauer. Despite having poor health outcomes, patients with this etiology of Cushing’s syndrome have not been rigorously studied." GRADIENT is expected to enroll 130 patients at sites in the United States and Europe. Many of the clinical sites participating in GRADIENT are already participating in GRACE.

Metabolic Disease

Phase 2 trial of miricorilant to reverse recent APIWG actively enrolling patients
Phase 2 trials of miricorilant to reverse long-standing APIWG and to treat patients with NASH
planned to start in fourth quarter
"The exciting recent developments in our program in metabolic disorders build on years of work," said Dr. Grauer. "We know from data with mifepristone that cortisol modulation has the potential to treat APIWG2 and NASH. Both of these serious disorders afflict millions of people. Last year, our Phase 1b trial showed that our selective cortisol modulator miricorilant at 600 mg was active in mitigating weight gain in healthy volunteers administered olanzapine. Next quarter, we will have results from a 900 mg dose cohort. Our double-blind, placebo-controlled Phase 2 trial of miricorilant in patients with schizophrenia and recent APIWG is now actively enrolling. By year-end, we plan to start testing an improved formulation of miricorilant in two double-blind, placebo-controlled Phase 2 trials – one in patients with long-standing APIWG and another in patients with NASH.

Solid Tumors

Controlled, Phase 2 trial of relacorilant plus nab-paclitaxel to treat metastatic ovarian cancer actively enrolling patients at sites in the United States and Europe, on track to produce results in first half of 2021
Phase 3 trial of relacorilant plus nab-paclitaxel to treat patients with metastatic pancreatic cancer
to start in second quarter
Phase 1b trial of relacorilant plus the immunotherapeutic agent pembrolizumab (Keytruda) to treat patients with metastatic or unresectable adrenocortical cancer to start in second quarter
"Our oncology program continues to mature," said Dr. Grauer. "At the American Society of Clinical Oncologists (ASCO) (Free ASCO Whitepaper) annual meeting last June, we presented striking results from our open-label, Phase 1/2 trial of relacorilant plus nab-paclitaxel in patients with ovarian and pancreatic cancers.3 We are seeking to confirm those findings. Our controlled, Phase 2 trial of relacorilant plus nab-paclitaxel is actively enrolling patients with metastatic ovarian cancer at 22 sites in the United States and Europe. We expect results in the first half of 2021. Next quarter, we plan to begin a Phase 3 trial of relacorilant plus nab-paclitaxel in patients with metastatic pancreatic cancer. Our trial design reflects guidance we have received from the FDA and may enable accelerated approval.

"In the second quarter, we plan to start a Phase 1b trial of relacorilant combined with the PD-1 checkpoint inhibitor pembrolizumab to treat metastatic or unresectable adrenal cancer, a disease with a very poor prognosis. Patients with adrenal cancer often suffer from Cushing’s syndrome. Our hypothesis is that by modulating the effects of cortisol, relacorilant can alleviate the symptoms of Cushing’s syndrome and, by countering the immunosuppressive effect of cortisol activity, help pembrolizumab achieve its full effect.

"Finally, we expect to conclude by year-end the dose-finding trial of our proprietary cortisol modulator exicorilant in combination with enzalutamide in castration-resistant prostate cancer."

Conference Call

We will hold a conference call on February 20, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-800-367-2403 from the United States or 1-334-777-6978 internationally approximately ten minutes before the start of the call (passcode 7085899). A replay will be available through March 5, 2020 at 1-888-203-1112 in the United States and 1-719-457-0820 internationally (passcode 7085899).

On February 20, 2020 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM) reported results for its fourth quarter and year ended December 31, 2019 (Press release, Select Medical, FEB 20, 2020, View Source [SID1234554577]).

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For the fourth quarter ended December 31, 2019, net operating revenues increased 8.7% to $1,374.6 million, compared to $1,264.7 million for the same quarter, prior year. Income from operations increased 27.3% to $112.4 million for the fourth quarter ended December 31, 2019, compared to $88.3 million for the same quarter, prior year. Net income increased 46.9% to $43.7 million for the fourth quarter ended December 31, 2019, compared to $29.7 million for the same quarter, prior year. For the fourth quarter ended December 31, 2019, net income included pre-tax losses on early retirement of debt of $19.4 million. For the fourth quarter ended December 31, 2018, net income included pre-tax losses on early retirement of debt of $3.9 million. Adjusted EBITDA increased 16.9% to $171.9 million for the fourth quarter ended December 31, 2019, compared to $147.1 million for the same quarter, prior year. Earnings per common share increased to $0.24 on a fully diluted basis for the fourth quarter ended December 31, 2019, compared to $0.18 for the same quarter, prior year. Adjusted earnings per common share was $0.31 on a fully diluted basis for the fourth quarter ended December 31, 2019, compared to $0.20 for the same quarter, prior year. Adjusted earnings per common share excludes the losses on early retirement of debt and their related tax effects for both the fourth quarters ended December 31, 2019 and 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

For the year ended December 31, 2019, net operating revenues increased 7.3% to $5,453.9 million, compared to $5,081.3 million for the prior year. Income from operations increased 13.1% to $471.9 million for the year ended December 31, 2019, compared to $417.3 million for the prior year. Net income increased 13.6% to $201.0 million for the year ended December 31, 2019, compared to $176.9 million for the prior year. For the year ended December 31, 2019, net income included pre-tax losses on early retirement of debt of $38.1 million and a pre-tax gain on sale of businesses of $6.5 million. For the year ended December 31, 2018, net income included pre-tax losses on early retirement of debt of $14.2 million, pre-tax gains on sales of businesses of $9.0 million, and pre-tax U.S. HealthWorks acquisition costs of $2.9 million. Adjusted EBITDA increased 10.2% to $710.9 million for the year ended December 31, 2019, compared to $645.2 million for the prior year. Earnings per common share increased to $1.10 on a fully diluted basis for the year ended December 31, 2019, compared to $1.02 for the prior year. Adjusted earnings per common share was $1.24 on a fully diluted basis for the year ended December 31, 2019, compared to $1.03 for the prior year. Adjusted earnings per common share excludes the losses on early retirement of debt and related costs and gain on sale of businesses and their related tax effects for the year ended December 31, 2019. Adjusted earnings per common share excludes the losses on early retirement of debt, gains on sales of businesses, U.S. HealthWorks acquisition costs, and their related tax effects for the year ended December 31, 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

Company Overview

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Select Medical’s reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of December 31, 2019, Select Medical operated 101 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,740 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 521 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At December 31, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Critical Illness Recovery Hospital Segment

For the fourth quarter ended December 31, 2019, net operating revenues for the critical illness recovery hospital segment increased 6.7% to $454.9 million, compared to $426.3 million for the same quarter, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 8.0% to $60.5 million for the fourth quarter ended December 31, 2019, compared to $56.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 13.3% for the fourth quarter ended December 31, 2019, compared to 13.1% for the same quarter, prior year. Certain critical illness recovery hospital key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the critical illness recovery hospital segment increased 4.7% to $1,836.5 million, compared to $1,753.6 million for the prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 4.9% to $254.9 million for the year ended December 31, 2019, compared to $243.0 million for the prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 13.9% for both the years ended December 31, 2019 and 2018. Certain critical illness recovery hospital key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Rehabilitation Hospital Segment

For the fourth quarter ended December 31, 2019, net operating revenues for the rehabilitation hospital segment increased 20.9% to $182.7 million, compared to $151.1 million for the same quarter, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 51.4% to $43.3 million for the fourth quarter ended December 31, 2019, compared to $28.6 million for the same quarter, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 23.7% for the fourth quarter ended December 31, 2019, compared to 18.9% for the same quarter, prior year. For the fourth quarter ended December 31, 2018, the Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $0.9 million. Certain rehabilitation hospital key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the rehabilitation hospital segment increased 14.9% to $671.0 million, compared to $583.7 million for the prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 24.7% to $135.9 million for the year ended December 31, 2019, compared to $108.9 million for the prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 20.2% for the year ended December 31, 2019, compared to 18.7% for the prior year. The Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $8.8 million for the year ended December 31, 2019, compared to approximately $4.7 million for the prior year. Certain rehabilitation hospital key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Outpatient Rehabilitation Segment

For the fourth quarter ended December 31, 2019, net operating revenues for the outpatient rehabilitation segment increased 7.7% to $271.9 million, compared to $252.4 million for the same quarter, prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 14.9% to $40.2 million for the fourth quarter ended December 31, 2019, compared to $35.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 14.8% for the fourth quarter ended December 31, 2019, compared to 13.9% for the same quarter, prior year. Certain outpatient rehabilitation key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the outpatient rehabilitation segment increased 5.0% to $1,046.0 million, compared to $995.8 million for the prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 6.9% to $151.8 million for the year ended December 31, 2019, compared to $142.0 million for the prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 14.5% for the year ended December 31, 2019, compared to 14.3% for the prior year. Certain outpatient rehabilitation key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Concentra Segment

The financial results for the Concentra segment include U.S. HealthWorks beginning February 1, 2018.

For the fourth quarter ended December 31, 2019, net operating revenues for the Concentra segment increased 3.4% to $397.1 million, compared to $384.3 million for the same quarter, prior year. Adjusted EBITDA for the Concentra segment increased 6.8% to $56.5 million for the fourth quarter ended December 31, 2019, compared to $52.9 million for the same quarter, prior year. The Adjusted EBITDA margin for the Concentra segment was 14.2% for the fourth quarter ended December 31, 2019, compared to 13.8% for the same quarter, prior year. Certain Concentra key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the Concentra segment increased 4.6% to $1,628.8 million, compared to $1,557.7 million for the prior year. Adjusted EBITDA for the Concentra segment increased 9.7% to $276.5 million for the year ended December 31, 2019, compared to $252.0 million for the prior year. The Adjusted EBITDA margin for the Concentra segment was 17.0% for the year ended December 31, 2019, compared to 16.2% for the prior year. Certain Concentra key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Stock Repurchase Program

The board of directors of Select Medical has authorized a common stock repurchase program to repurchase up to $500.0 million worth of shares of its common stock. The program has been extended until December 31, 2020, and will remain in effect until then, unless further extended or earlier terminated by the board of directors. Stock repurchases under this program may be made in the open market or through privately negotiated transactions, and at times and in such amounts as Select Medical deems appropriate. Select Medical funds this program with cash on hand and borrowings under its revolving credit facility.

During the year ended December 31, 2019, Select Medical repurchased 2,165,221 shares at a cost of approximately $33.2 million, or $15.32 per share, which includes transaction costs. Since the inception of the program through December 31, 2019, Select Medical has repurchased 38,089,349 shares at a cost of approximately $347.9 million, or $9.13 per share, which includes transaction costs.

Financing Transactions

On December 10, 2019, Select Medical issued and sold $675.0 million aggregate principal amount of 6.250% senior notes, due August 15, 2026, as additional notes under the indenture dated August 1, 2019, pursuant to which it previously issued $550.0 million of 6.250% senior notes due 2026. The additional senior notes were issued at 106.00% of the aggregate principal amount.

On December 10, 2019, Select Medical entered into Amendment No. 4 to its senior secured credit agreement. Among other things, Amendment No. 4 provided for an additional $615.0 million in term loans that, along with the existing term loans, have a maturity date of March 6, 2025.

Select Medical used a portion of the net proceeds from the incremental term loans, together with a portion of the net proceeds of the 6.250% additional senior notes, to make a first lien term loan in the aggregate principal amount of approximately $1,240.3 million to Concentra Inc., pursuant to an intercompany loan agreement. Concentra Inc. used the proceeds from the intercompany loan to repay in full the first lien term loan outstanding under Concentra Inc.’s first lien credit agreement. Concentra Inc. continues to have availability of up to $100.0 million under its existing revolving credit facility.

Purchase of Concentra Interest

On January 1, 2020, Select Medical, Welsh, Carson, Anderson & Stowe XII, L.P. ("WCAS"), and Dignity Health Holding Corporation ("DHHC") entered into an agreement pursuant to which Select Medical acquired approximately 17.2% of the outstanding membership interests of Concentra Group Holdings Parent, LLC ("Concentra Parent") on a fully diluted basis from WCAS, DHHC, and other equity holders of Concentra Parent for approximately $338.4 million. On February 1, 2020, Select Medical, WCAS and DHHC entered into an agreement pursuant to which Select Medical acquired an additional 1.4% of the outstanding membership interests of Concentra Parent on a fully diluted basis from WCAS, DHHC, and other equity holders of Concentra Parent for approximately $27.8 million.

These purchases were in lieu of, and considered to be, the exercise of the first put right provided to certain equity holders under the terms of the Amended and Restated Limited Liability Company Agreement of Concentra Parent, dated as of February 1, 2018. Following these purchases, Select Medical owns approximately 66.6% of the outstanding membership interests of Concentra Parent on a fully diluted basis and approximately 68.8% of the outstanding voting membership interests of Concentra Parent.

Business Outlook

Select Medical reaffirms its 2020 business outlook, provided most recently in its January 27, 2020 press release, for net operating revenues, Adjusted EBITDA and fully diluted earnings per common share. Select Medical continues to expect consolidated net operating revenues for the full year 2020 to be in the range of $5.575 billion to $5.675 billion. Select Medical continues to expect Adjusted EBITDA for the full year 2020 to be in the range of $725.0 million to $760.0 million. Select Medical continues to expect fully diluted earnings per common share for the full year 2020 to be in the range of $1.27 to $1.46.

Conference Call

Select Medical will host a conference call regarding its results for the fourth quarter and full year ended December 31, 2019, as well as its business outlook, on Friday, February 21, 2020, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 8644656. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, February 28, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 8644656. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

On February 20, 2020 Montis Biosciences reported its launch with €8,4 million in seed financing from an international investor syndicate to investigate interactions between perivascular macrophages and tumor vasculature (Press release, Montis Biosciences, FEB 20, 2020, View Source [SID1234568646]). The company’s mission is to exploit these cellular interactions with therapeutics to drive and sustain immune reactions against solid tumors.

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Montis was founded by Droia Ventures, VIB and KU Leuven based on the foundational science discovered by the labs of Peter Carmeliet (VIB-KU Leuven) and Massimiliano Mazzone (VIB-KU Leuven). For the seed financing, the founders were joined by new investors Polaris Partners, ALSA Ventures and Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE).

Blood vessels regulate the influx of immune cells into tumors. They do so under direction of perivascular macrophages, which can stimulate blood vessels to attract immune cells and let them pass into the tumor, or can induce blood vessel dysfunction and create an immune-compromised environment or suppressive environment in the tumor. Montis’ proprietary insights into how these two classes of cells interact now allows for modulation of these interactions to ensure a strong influx of fresh immune cells into the tumor. The seed financing will allow Montis to prioritize among a set of targets and to validate its lead programs for further development towards clinical studies. Montis will also expand its unique screening and assay platform to identify and validate additional promising targets.

"It is becoming increasingly clear that endothelial cells in the tumor vasculature play a major role in immune reactions to cancer and that their interaction with immune cells shapes this response. Historical therapies targeting the tumor vasculature largely ignored this role and instead destroyed the vessels to starve the tumor," says professor Peter Carmeliet. "Our research is showing that rather than destroying blood vessels, we can use them to herd the correct immune cells to the tumor and get much more potent and sustainable effects."

"Our approach with single-cell RNA-sequence data finally allows us to investigate the communication between immune cells and the tumor vasculature," adds professor Massimiliano Mazzone. "Montis is the step forward to translate this concept into therapeutic applications."

Montis’ Board of Directors will be composed of Executive Chairman and Droia Partner, Luc Dochez, and VIB Head New Ventures, Griet Vanpoucke, who will be joined by Ellie McGuire (Polaris Partners), Sohaib Mir (ALSA Ventures) and Rana Al-Hallaq (Pfizer Ventures).

"We’re very pleased to have been able to bring together the world-class science from the VIB-KU Leuven labs of Peter Carmeliet and Massimiliano Mazzone with an investor syndicate that is excellently positioned to ensure the long-term success of the company," says Luc Dochez, Partner at Droia Ventures and Executive Chairman at Montis. "Montis has a unique approach to target solid tumors that should be able to really shift the paradigm on multiple indications."

"We are excited to work with Droia Ventures in this oncology focused company co-creation effort," comments Johan Cardoen, managing director of VIB. "Montis is a prime example of how scientific excellence complemented with an entrepreneurial mindset and hands-on early stage investors can result in a promising new venture."

On February 20, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported financial results for the fourth quarter and full year ended December 31, 2019 (Press release, Compugen, FEB 20, 2020, View Source [SID1234554542]).

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"2019 was a transformative year for Compugen and we are incredibly proud of the progress we have made in advancing COM701 and COM902," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We are excited about our unique position in the immuno-oncology space as to our knowledge we are the only company with two clinical programs that address PVRIG and TIGIT, parallel inhibitory pathways of the DNAM axis. This differentiator is particularly important given the increasing excitement and growing recognition of the DNAM axis in cancer immunotherapy as evidenced by the development of other TIGIT antibodies in pharma. In addition, the encouraging initial signals of anti-tumor activity with COM701 monotherapy in an extremely challenging, refractory, all-comer population, has bolstered our conviction that targeting PVRIG as a newly discovered inhibitory pathway in the larger DNAM axis, has the potential to expand the reach of cancer immunotherapy."

Dr. Cohen-Dayag continued, "We are also thrilled to expand our clinical collaboration with Bristol-Myers Squibb and to initiate a Phase 1/2 study evaluating a triple combination of COM701 in combination with Opdivo and BMS-986207, Bristol-Myers Squibb’s TIGIT inhibitor. This will allow us to immediately move COM701 to a triple combination study blocking three immune checkpoint pathways – PVRIG, TIGIT and PD-1 – and accelerate the evaluation of our hypothesis that simultaneous blockade of the DNAM axis in addition to PD-1 will enable robust activation of T cells, potentially leading to enhanced anti-tumor responses in certain patients who are not responsive to PD-1 blockers alone. We look forward to our continued evolution with important milestones in our clinical programs."

Recent and 2019 Corporate Highlights

Announced plans to expand the Bristol-Myers Squibb collaboration with a Phase 1/2 triple combination study to evaluate COM701 in combination with Opdivo and BMS-986207, Bristol-Myers Squibb’s TIGIT inhibitor. The study is expected to begin in 2H 2020.

Presented initial clinical findings from ongoing Phase 1 trial of COM701 in patients with advanced solid tumors at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019)

COM701 was well-tolerated with no dose-limiting toxicities observed.

Initial signals of anti-tumor activity were observed in the heavily pretreated, all-comers patient population enrolled in the study.

Presented trial-in-progress data at ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium from the Phase 1 study evaluating COM701 as a monotherapy and in combination with Opdivo (nivolumab)

Enrollment in the eighth dose level patient cohort of 20mg/kg at Q4 weekly dosing schedule is ongoing in the monotherapy dose escalation study.

Enrollment in the fourth dose level patient cohort at Q4 weekly dosing schedule in the combination dose escalation study of COM701 with Opdivo has been completed. No dose-limiting toxicities have been reported.

Announced Investigational New Drug application clearance by the U.S. Food and Drug Administration for COM902. A Phase 1 trial in patients with advanced malignancies is expected to begin in early 2020.

Presented new preclinical data on COM902 at SITC (Free SITC Whitepaper) 2019, supporting its potential best-in-class binding affinity and clinical use as a cancer immunotherapy treatment in combination with COM701 and PD-1 inhibitors.

Strengthened intellectual property portfolio related to COM701 and COM902

Granted U.S. Patent No. 10,213,505, covering the composition of COM701 and backup antibodies.

Granted U.S. Patent No. 10,227,408, covering the composition of an anti-PVRIG antibody having complementarity-determining regions (CDRs) of COM701 and backup antibodies.

Granted U.S. Patent No. 10,351,625, covering the method of use of COM701 or backup antibody in combination with anti-PD-1 antibodies.

Granted EPO Patent No. EP3347379, covering the composition of matter of COM902, alone or with second antibody that binds to a human checkpoint receptor protein, including PD-1 and its use.

Granted EPO Patent No. EP3258951, covering the use of any anti-PVRIG antibody that activates T cells and/or NK cells, in the treatment of cancer.

Granted U.S. Patent No. 10,550,173, covering methods of screening for anti-PVRIG antibodies that inhibit the binding of PVRIG with PVRL2.

Financial Results

Research and development expenses for the fourth quarter and year ended December 31, 2019, were $4.3 million, and $19.8 million, respectively, compared with $7.5 million and $30.3 million for the prior periods in 2018. The decrease in both cases is attributed mostly to the restructuring process we announced at the end of the first quarter of 2019, as well as preclinical activities related to COM902, most of which were concluded in 2018. This reduction was offset by an increase in expenses associated with clinical-related activities of the COM701 Phase 1 trial, which began in the second half of 2018.

Net loss for the fourth quarter of 2019 was $6.5 million, or $0.10 per basic and diluted share, compared with a net loss of $9.4 million, or $0.16 per basic and diluted share, in the comparable period of 2018. Net loss for the year ended December 31, 2019 was $27.3 million, or $0.43 per basic and diluted share, compared with a net loss of $22.6 million, or $0.41 per basic and diluted share, for the year ended December 31, 2018.

As of December 31, 2019, cash, cash related accounts, short-term and long-term bank deposits totaled approximately $43.9 million, compared with approximately $45.7 million as of December 31, 2018. The Company has no debt.

Conference Call and Webcast Information
The Company will hold a conference call today, February 20, 2020, at 8:30 AM ET to review its fourth quarter and full year 2019 results. To access the conference call by telephone, please dial 1-888-407-2553 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On February 20, 2020 PRA Health Sciences, Inc. ("PRA" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter and year ended December 31, 2019 (Press release, PRA Health Sciences, FEB 20, 2020, View Source [SID1234554560]).

"We are pleased with our financial results for the quarter and are delighted to have delivered double digit constant currency revenue growth and double digit adjusted earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the year, we strengthened our leadership in Strategic Solutions, Product Registration, and Symphony Health and we believe we are very well positioned for the coming year. In 2020, we will continue to focus on our key strategic initiatives and to providing broad and flexible services to our clients."

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Net new business for our Clinical Research segment for the three months ended December 31, 2019 was $658.9 million, representing a net book-to-bill ratio of 1.21 for the period. This net new business contributed to an ending backlog of $4.7 billion at December 31, 2019.

For the three months ended December 31, 2019, revenue was $800.2 million, which represents growth of 9.7%, or $70.6 million, compared to the fourth quarter of 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $74.5 million, an increase of 10.2% compared to the fourth quarter of 2018. By segment, the Clinical Research segment generated revenues of $725.1 million, while the Data Solutions segment generated revenues of $75.1 million.

Direct costs, exclusive of depreciation and amortization, were $386.1 million during the three months ended December 31, 2019 compared to $365.7 million for the three months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased by $24.7 million compared to the fourth quarter of 2018. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 48.2% of revenue during the fourth quarter of 2019 compared to 50.1% of revenue during the fourth quarter of 2018.

Selling, general and administrative expenses were $103.5 million during the three months ended December 31, 2019 compared to $96.4 million for the three months ended December 31, 2018. Selling,

general and administrative costs were 12.9% of revenue during the fourth quarter of 2019 compared to 13.2% of revenue during the fourth quarter of 2018.

GAAP net income attributable to PRA was $74.8 million for the three months ended December 31, 2019, or $1.16 per share on a diluted basis, compared to $71.5 million for the three months ended December 31, 2018, or $1.07 per share on a diluted basis.

EBITDA was $124.9 million for both the three months ended December 31, 2019 and December 31, 2018. Adjusted EBITDA was $148.5 million for the three months ended December 31, 2019, representing growth of 9.0% compared to the three months ended December 31, 2018.

Adjusted net income was $98.7 million for the three months ended December 31, 2019, representing 13.6% growth compared to the three months ended December 31, 2018. Adjusted net income for the three months ended December 31, 2019 includes the effects of a reduction in our effective tax rate from 24% to 23%. The decrease in our effective tax rate is primarily attributable to the geographic distribution of our pre-tax earnings. Adjusted net income per diluted share was $1.54 for the three months ended December 31, 2019, representing 17.6% growth compared to the three months ended December 31, 2018.

Full Year 2019 Financial Highlights

For the twelve months ended December 31, 2019, revenue was $3,066.3 million, which represents growth of 6.8%, or $194.3 million, compared to the twelve months ended December 31, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $225.2 million, representing growth of 7.8% compared to the twelve months ended December 31, 2018. By segment, the Clinical Research segment generated revenues of $2,813.0 million, while the Data Solutions segment generated revenues of $253.3 million.

GAAP income from operations was $363.9 million. GAAP net income attributable to PRA was $243.0 million, or $3.68 per share on a diluted basis, for the twelve months ended December 31, 2019.

Adjusted net income was $341.0 million for the twelve months ended December 31, 2019, an improvement of 20.0% compared to the twelve months ended December 31, 2018. Adjusted net income per diluted share was $5.17 for the twelve months ended December 31, 2019, up 20.8% compared to the twelve months ended December 31, 2018.

Full Year 2020 and Q1 2020 Guidance

For full year 2020, the Company expects to achieve total revenues between $3.23 billion and $3.36 billion, representing as reported and constant currency growth of 5.0% to 9.5%.

We expect GAAP net income per diluted share of between $4.01 and $4.21 per share and adjusted net income per diluted share of between $5.77 and $5.97 per share, representing growth of 12% to 15%. We anticipate an annual effective income tax rate estimate of 23%.

Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in interpretations, analysis, and additional guidance that may be issued by regulatory agencies.

For Q1 2020, the Company expects to achieve total revenues between $765.0 million and $787.0 million, representing as reported and constant currency growth of 6% to 9%. The Company expects GAAP net

income per diluted share of between $0.59 and $0.69 per share, adjusted net income per diluted share between $1.05 and $1.15 per share, and an annual effective income tax rate of 23%.

Our 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30 with all other foreign currencies using a rate as of January 31, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per share and our 2020 guidance, to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on February 21, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 5667733. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 5667733.

Additional Information

A financial supplement with fourth quarter 2019 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q4 2019 Earnings Presentation."