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."

On February 20, 2020 Danaher Corporation (NYSE: DHR) reported that its Board of Directors has approved a regular quarterly cash dividend of $0.18 per share of its common stock, payable on April 24, 2020 to holders of record on March 27, 2020 (Press release, Danaher, FEB 20, 2020, View Source [SID1234554578]). In addition, Danaher announced today that its Board of Directors has approved a quarterly cash dividend of $11.875 per share of its 4.75% Series A Mandatory Convertible Preferred Stock, payable on April 15, 2020 to holders of record on March 31, 2020.

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On February 20, 2020 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported fourth quarter 2019 financial results on Thursday, February 27, 2020, after the close of U.S. markets (Press release, CytomX Therapeutics, FEB 20, 2020, View Source [SID1234554543]). Following the announcement, the company will host a conference call beginning at 5:00 p.m. ET to discuss its results.

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Participants may access the live audio webcast of the teleconference from the "Investors & News" section of CytomX’s website at View Source Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Audio Conference Call:

U.S. Dial-in Number: (877) 809-6037

International Dial-in Number: (615) 247-0221

Conference ID: 1686972
An archived webcast replay will be available on the Company’s website from February 27, 2020, until March 5, 2020.

On February 20, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Puma Biotechnology, FEB 20, 2020, View Source [SID1234554561]). Unless otherwise stated, all comparisons are for the fourth quarter and full year 2019, compared to the fourth quarter and full year 2018.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net product revenue in the fourth quarter of 2019 was $58.7 million, compared to net product revenue of $61.1 million in the fourth quarter of 2018. Net product revenue for the full year 2019 was $211.6 million, compared to net product revenue of $200.5 million for the full year 2018.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported a net loss of $11.2 million, or $0.29 per share, for the fourth quarter of 2019, compared to a net loss of $30.7 million, or $0.80 per share, for the fourth quarter of 2018. Net loss for the full year 2019 was $75.6 million, or $1.95 per share, compared to $113.6 million, or $2.99 per share, for the full year 2018.

Non-GAAP adjusted net income was $0.3 million, or $0.01 per share, for the fourth quarter of 2019, compared to non-GAAP adjusted net loss of $12.2 million, or $0.32 per share, for the fourth quarter of 2018. Non-GAAP adjusted net loss for the full year 2019 was $18.3 million, or $0.47 per share, compared to non-GAAP adjusted net loss of $26.7 million, or $0.70 per share, for the full year 2018. Non-GAAP adjusted net income (loss) excludes stock-based compensation expense. For a reconciliation of GAAP net loss to non-GAAP adjusted net income (loss) and GAAP net loss per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2019 was $1.6 million, compared to net cash provided by operating activities of $7.1 million for the fourth quarter of 2018. Net cash provided by operating activities for the full year 2019 was $22.4 million, compared to net cash used in operating activities of $24.1 million for the full year 2018. At December 31, 2019, Puma had cash, cash equivalents and marketable securities of $111.6 million, compared to $165.4 million at December 31, 2018.

"During 2019, Puma made broad strides to increase global commercial access to NERLYNX by HER2-positive breast cancer patients, as well as to expand the label and potential therapeutic indications of NERLYNX," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "Our year concluded with a label expansion to address NERLYNX side effects, registration approval in Hong Kong and marketing approval in Singapore for NERLYNX, an expanded license agreement with Pierre Fabre, as well as several clinical data presentations at SABCS. We believe these regulatory, commercial, partnering and clinical milestones position Puma for improved results in 2020 and beyond."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) modifying the SUMMIT basket trial to expand the HER2-mutated breast cancer cohort in the first quarter of 2020; (ii) receiving a [U.S.] regulatory decision on neratinib in third-line HER2-positive metastatic breast cancer in the second quarter of 2020; (iii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2 mutated hormone receptor positive breast cancer and HER2 mutated cervical cancer in the fourth quarter of 2020; (iv) reporting Phase II data from the HER-positive breast and cervical cancer cohorts from the SUMMIT trial of neratinib in patients with HER2 mutations in the fourth quarter of 2020; (v) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2020; and (vi) receiving regulatory decisions for an extended adjuvant HER2-positive early stage breast cancer indication in additional countries."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue and royalty revenue. For the fourth quarter of 2019, total revenue was $62.9 million, of which $58.7 million was net product revenue, $4.0 million was license revenue received from Puma’s sub-licensees, and $0.2 million was royalty revenue. This compares to total revenue of $71.1 million in the fourth quarter of 2018, of which $61.1 million was net product revenue and $10.0 million was license revenue received from Puma’s sub-licensees. For the year ended December 31, 2019, total revenue was $272.3 million, of which $211.6 million was net product revenue, $60.3 million was license revenue received from Puma’s sub-licensees and $0.4 million was royalty revenue. This compares to total revenue of $251.0 million for the year ended December 31, 2018, of which $200.5 million was net product revenue and $50.5 million was license revenue received from Puma’s sub-licensees.

Operating Costs and Expenses

Total operating costs and expenses were $71.6 million for the fourth quarter of 2019, compared to $89.7 million for the fourth quarter of 2018. Total operating costs and expenses were $311.4 million for the full year 2019 compared to $345.7 million for the full year 2018.

Cost of Sales

Cost of sales was $10.1 million for the fourth quarter of 2019 and $36.8 million for the full year 2019, compared to $10.3 million for the fourth quarter of 2018 and $34.6 million for the full year 2018.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $31.3 million for the fourth quarter of 2019, compared to $41.0 million for the fourth quarter of 2018. Selling, general and administrative expenses for the full year 2019 were $141.7 million, compared to $146.2 million for full year 2018, a decrease of approximately $4.5 million. The decrease in SG&A expenses for the full year 2019 primarily related to decreases in stock-based compensation expense of approximately $7.0 million, and payroll and related costs of approximately $1.3 million. These decreases were partially offset by an increase in professional fees and expenses of approximately $2.7 million and an impairment loss of approximately $1.2 million.

Research and Development Expenses

Research and development expenses were $30.2 million for the fourth quarter of 2019, compared to $38.4 million for the fourth quarter of 2018. Research and development expenses for the full year 2019 were $132.9 million, compared to $164.9 million for the full year 2018. The decrease of approximately $32.0 million for the full year 2019 resulted primarily from decreases in stock-based compensation expense of approximately $22.6 million, internal R&D expense of approximately $4.7 million, clinical trial expenses of approximately $4.2 million, and consultant and contractor costs of approximately $0.5 million.

Total Other Income (Expenses)

Total other expenses were $2.5 million for the fourth quarter of 2019, compared to $12.1 million for the fourth quarter of 2018. Total other expenses were $36.5 million for the year ended December 31, 2019, compared to $18.9 million for the year ended December 31, 2018. The increase of $17.6 million during the full year 2019 compared to the full year 2018 primarily resulted from an increase in debt extinguishment loss of approximately $8.1 million, an increase in legal verdict expense of approximately $7.4 million, and an increase in interest expense of approximately $4.0 million, partially offset by an increase in interest and other income of approximately $1.9 million.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2019 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PST/4:30 p.m. EST on Thursday, February 20, 2020. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.