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 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 Cerus Corporation (Nasdaq: CERS) reported complete financial results for the fourth quarter and year ended December 31, 2019 (Press release, Cerus, FEB 20, 2020, View Source [SID1234554558]).

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Recent developments and highlights include:

Total fourth quarter revenue of $26.5 million.
Record fourth quarter product revenue of $20.9 million, a 27% increase compared to the prior year quarter.
Government contract revenue of $5.6 million.
Continued increase in worldwide demand for INTERCEPT kits during the fourth quarter with the calculated number of treatable platelet doses up 23% during the quarter compared to the same period in 2018.
Provided 2020 annual product revenue guidance of $89 million to $93 million, representing an approximately 20% to 25% increase over 2019 reported product revenue.
Strengthened balance sheet with an upsized public offering of common stock in January 2020 raising gross proceeds of $63.3 million.
Received CE mark approval for pathogen-reduced 5-day thawed plasma.
Entered collaboration with the National Trauma Institute to supply INTERCEPT plasma for the PROpOLIs clinical study, a U.S. Department of Defense funded clinical trial evaluating use of INTERCEPT plasma in traumatic burn resuscitation in 94 patients at 5 U.S. sites.
"We exited 2019 on a high note with record quarterly product revenue and anticipate the momentum that we experienced this past year will continue into 2020," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "We are looking forward to another successful year, as we expect many U.S. blood centers and hospitals to opt for INTERCEPT platelets as a strategy to comply with the final FDA guidance document on platelet safety. These institutions are on the clock and have just 13 more months to become compliant with the FDA Guidance."

The FDA guidance document on bacterial risk control strategies for platelets calls for all blood centers and hospitals to be compliant with new safety requirements by March 31, 2021.

"In addition to our commercial objectives goals for the year, we are looking forward to important regulatory milestones throughout 2020, led by our expected PMA-supplement submission for pathogen-reduced cryoprecipitate in the first half of the year," continued Greenman.

Revenue

Product revenue during the fourth quarter of 2019 was $20.9 million, compared to $16.5 million during the same period in 2018. Product revenue growth in the quarter benefited from strong continued demand for INTERCEPT platelet kits in the U.S. and platelet and plasma kit demand in EMEA, which were partially offset by the conversion to the double dose platelet kits in France and a 2% negative impact of foreign currency exchange rates. For the full year, product revenue totaled $74.6 million, an increase of 23% compared to the same period in 2018.

As a result of increased INTERCEPT red blood cell clinical and development activities, government contract revenue from the Company’s Biomedical Advanced Research and Development Authority (BARDA) agreement was $5.6 million during the fourth quarter of 2019, compared to $3.7 million during the same period in 2018. Full year 2019 government contract revenue totaled $19.1 million compared to $15.1 million in the same period the year prior. The total potential value of the current BARDA agreement is $201 million, with $44 million cumulatively recognized as government contract revenue to date.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the fourth quarter of 2019 were 56%, compared to 49% for the fourth quarter of 2018. The increase in gross margin was tied to economies of scale realized for our cost of goods sold, favorable platelet product mix, namely the French conversion to double dose platelet kits and additional manufacturing efficiencies. Gross margins on product revenue for the full year 2019 were 55% compared to 48% reported in the same period the year prior.

Operating Expenses

Total operating expenses for the fourth quarter of 2019 were $33.6 million compared to $27.3 million for the same period the prior year. Full year 2019 operating expenses totaled $126.6 million compared to $99.4 million for the full-year 2018.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2019 totaled $17.2 million, compared to $14.8 million for the fourth quarter of 2018. The year-over-year increase in SG&A expenses was tied to increased non-cash stock compensation, higher investments in our supply chain capabilities and focused investments on preparatory activities for our anticipated pathogen-reduced cryoprecipitate launch. Full-year 2019 SG&A expenses totaled $66.2 million compared to $56.8 million for the full-year 2018.

Research and development (R&D) expenses for the fourth quarter of 2019 were $16.4 million, compared to $12.4 million for the fourth quarter of 2018. The year-over-year increase in R&D expenses was due in part to product enhancements and initiatives for expanded label claims, development activities to support our planned PMA supplement for pathogen-reduced cryoprecipitate, as well as activities related to the development of our INTERCEPT red blood cell system. Full-year 2019 R&D expenses totaled $60.4 million compared to $42.6 million for the full-year 2018.

Net Loss

Net loss for the fourth quarter of 2019 was $16.9 million, or $0.12 per diluted share, compared to a net loss of $16.2 million, or $0.12 per diluted share, for the fourth quarter of 2018. Full-year 2019 net loss was $71.2 million or $0.51 per diluted share compared to $57.6 million, or $0.44 per diluted share for the same period in 2018.

Cash, Cash Equivalents and Investments

At December 31, 2019, the Company had cash, cash equivalents and short-term investments of $85.7 million, compared to $117.6 million at December 31, 2018.

At December 31, 2019, the Company had approximately $39.4 million in outstanding term loan debt and $5.0 million of borrowings under its revolving loan credit agreement, compared to $29.9 million in outstanding term loan debt at December 31, 2018.

In January 2020, the Company completed an underwritten public offering of its common stock for gross proceeds of $63.3 million, before deducting offering expenses payable by the Company.

2020 Product Revenue Guidance

The Company expects 2020 product revenue to be in the range of $89 million to $93 million. The guidance range represents approximately 20% to 25% growth compared to 2019 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 9268122. The replay will be available approximately three hours after the call through March 5, 2020.

On February 20, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported results from the monotherapy and combination arms of the Company’s ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC) at the IASLC 2020 Targeted Therapies of Lung Cancer Meeting in Santa Monica, California (Press release, Advaxis, FEB 20, 2020, View Source [SID1234554557]). The trial is evaluating ADXS-503, part of the Company’s ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis’ proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy.

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Key findings presented by Jennifer Carlisle, M.D., Assistant Professor Department of Hematology and Medical Oncology, Winship Cancer Institute of Emory University and study investigator, titled, "A Phase 1/2 Study of ADXS-503 Alone and in Combination with Pembrolizumab in Subjects with Metastatic Squamous or Non-Squamous Non-Small Cell Lung Cancer" include:

●Nine patients have been dosed to date; seven in the monotherapy arm and two in the combination arm, with a total of seven evaluable patients
●50% (3 of 6) of evaluable patients from the monotherapy arm, from Part A, showed stable disease
●The first evaluable patient from the combination arm, Part B, who previously progressed on pembrolizumab, showed stable disease with a 25% reduction in a site lesion
●Stable disease was observed in a heavily pretreated patient population with patients failing up to six prior lines of therapy and most patients progressing on prior immunotherapy treatments
●ADXS-503 monotherapy and in combination with pembrolizumab appeared safe and tolerable in this heavily pretreated population of patients with no dose limiting toxicities observed
●Treatment-related adverse events were mostly Grade 1-2, with no additive toxicity observed with combination therapy

"The presented preliminary data on safety, tolerability and disease stabilization with ADXS-503 in patients with advanced NSCLC provides an important clinical proof-of-concept to the Company’s first off-the shelf, hotspot neoantigen construct tested thus far," said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. "These data are important given the highly refractory patient population with most evaluated patients progressing on prior immunotherapies and, while early, we are particularly interested in documenting additional potential signals of synergy with KEYTRUDA. We look forward to reporting additional clinical and immunogenicity data later this year in addition to starting Part C of the study which will evaluate ADXS-503 in combination with pembrolizumab as a first-line treatment for NSCLC patients."

The Phase 1/2 clinical trial of ADXS-503 will seek to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a checkpoint inhibitor in approximately 50 patients with NSCLC, in at least five sites across the U.S. The two dose levels with monotherapy in Part A, (1 X108 and 5 X108 CFU) have been completed and Part B in combination with a checkpoint inhibitor is currently open to enrollment.

About ADXS-HOT

ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or "public" mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.

On February 20, 2020 Lantheus Holdings, Inc. (NASDAQ: LNTH) ("Lantheus"), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, and Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) ("Progenics"), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer, reported that they have entered into an Amended and Restated Agreement and Plan of Merger (the "Amended Agreement") which amends the previously announced definitive Agreement and Plan of Merger dated as of October 1, 2019 (the "Original Agreement") (Press release, Progenics Pharmaceuticals, FEB 20, 2020, View Source [SID1234554556]). The Amended Agreement has been unanimously approved by the Boards of Directors of both companies.

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Under the terms of the Amended Agreement, Lantheus will acquire all of the issued and outstanding shares of Progenics common stock at a fixed exchange ratio whereby Progenics stockholders will receive, for each share of Progenics stock held at the time of the closing of the merger, 0.31 of a share of Lantheus common stock, increased from 0.2502 under the Original Agreement, together with a non-tradeable contingent value right ("CVR"). The CVR is payable in two separate cash payments if PyLTM (18F-DCFPyL), Progenics’ prostate-specific membrane antigen targeted imaging agent designed to visualize prostate cancer currently in late stage clinical development ("PyL"), exceeds net sales thresholds of $100 million in 2022 and $150 million in 2023. As a result of the increase in the exchange ratio, following the completion of the merger, former Progenics stockholders’ aggregate ownership stake will increase to approximately 40% of the combined company from approximately 35% under the terms set forth in the Original Agreement.

Mary Anne Heino, President and Chief Executive Officer of Lantheus, said, "After continued integration planning with Progenics and close collaboration with Progenics’ reconstituted Board of Directors, we are even more excited about the potential value we can unlock by combining our two businesses. We remain confident that together, we will create a platform that leverages Lantheus’ long-standing expertise in complex manufacturing, supply chain and commercial excellence, with Progenics’ three leading FDA approved products, clinical pipeline and development capabilities. Our team enthusiastically shares the view of Progenics stockholders in the long-term growth potential of the Progenics product portfolio and, with our complementary strengths, our combined company will be better able to serve patients and healthcare professionals across the continuum of critical diagnosis and care. We are also pleased with the progress the two companies have made toward closing throughout our discussions."

Gérard Ber, Ph.D. and Mr. Heinz Mäusli, two members of Progenics’ reconstituted Board, will join the Lantheus Board upon closing. Lantheus will reduce its current ten member Board to nine members at its 2020 stockholders meeting, or sooner if this transaction closes before then. Lantheus will further reduce its Board to eight members at its 2021 stockholders meeting. As previously announced, the combined company will be led by Lantheus Chief Executive Officer Mary Anne Heino, who will be supported by Chief Financial Officer Robert J. Marshall Jr., CFA, and Chief Operations Officer John Bolla.

Brian Markison, Chairman of the Board of Lantheus, said, "We are excited about the additions of Dr. Ber and Mr. Mäusli to our board. Both Dr. Ber and Mr. Mäusli add experience in radiopharmaceuticals with deep manufacturing, operating, finance and compliance experience."

Ann MacDougall, Interim Chair of Progenics’ Board, said, "We have been pleased to work with Lantheus on the amended merger agreement. The Progenics’ Board has unanimously determined that the combination with Lantheus under the updated terms is in the best interest of our stockholders. The merger creates a stronger combined platform that offers an innovative and diversified diagnostic and therapeutics portfolio while ensuring stockholders the opportunity to participate in the future potential upside through enhanced ownership and the CVRs. The reconstituted Progenics Board, assisted by independent financial and legal advisors, has evaluated the business prospects and operations of Progenics as a stand-alone business as well as the value of the Progenics interest in the combined company under the revised terms in the merger transaction, and have concluded that the combination is the better path forward. We are also pleased to have our directors, Dr. Gérard Ber and Mr. Heinz Mäusli, join the Board of the combined company to enhance its prospects for future success."

David Mims, Interim CEO of Progenics, added, "We believe the combination will add significant value to both companies’ stockholders, especially in light of the recent positive results we achieved with our PyL Phase 3 CONDOR trial and our product pipeline and research and development capabilities."

Lantheus’ Strategic Plan for Progenics

As previously announced on November 7, 2019, Lantheus provided a strategic plan that provides stockholders of both companies with a clear and thoughtful strategy in which Lantheus will leverage its existing infrastructure and long-standing expertise to deliver on the promise of Progenics’ product portfolio and maximize value for all stockholders. The Lantheus team remains confident in the combination with Progenics as Lantheus has a clear track record of creating significant stockholder value, built on in-house operational excellence, commercial expertise, financial discipline and robust corporate governance.

In addition, through its extensive due diligence process and continued discussions with the Progenics Board, Lantheus has identified actions and investments in 2020 that will help enhance the progress of AZEDRA and the PyL and 1095 programs. Lantheus remains well-positioned to ensure that the Progenics portfolio has the benefit of access to cost-effective capital, manufacturing capabilities, logistical support and personnel resources to succeed.

With a focus on commercial, operational and clinical enhancements under the management of its proven team, Lantheus’ strategic plan represents the highest value, most certain and expedient path forward to drive significant, long-term value for stockholders of both Progenics and Lantheus.

Strong Financial Rationale

As a result of the recently reported positive top line results from the PyL Phase 3 CONDOR trial and ongoing integration planning, Lantheus believes this combination can generate double digit revenue growth, as well as drive margin expansion through the previously disclosed 2023 planning horizon. Accordingly, Lantheus continues to believe it can achieve adjusted EPS accretion in the third year following the close of the transaction.

Additional Transaction Details

Lantheus has also agreed to make available to Progenics up to $10 million of bridge financing on terms mutually agreed upon by the parties. The merger transaction is expected to close early in the second quarter of 2020, subject to approval by Lantheus and Progenics stockholders and satisfaction of other customary closing conditions.

Upon completion of the acquisition, the combined company will continue to be headquartered in North Billerica, Massachusetts and will trade on the NASDAQ under the ticker symbol: LNTH.

Advisors

SVB Leerink LLC is acting as financial advisor and White & Case LLP is acting as legal counsel to Lantheus. Progenics engaged BofA Securities, Inc. as financial advisor and previously engaged Jefferies LLC as existing lead financial advisor. Covington & Burling LLP and Mayer Brown LLP serve as independent legal advisors to Progenics.

Lantheus’ comprehensive strategic plan, along with additional documents related to its proposed acquisition of Progenics, can be viewed at www.lantheusprogenics.transactionannouncement.com/, and can also be viewed on the SEC’s website at www.sec.gov.