On February 13, 2023 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Medpace, FEB 13, 2023, View Source [SID1234627141]).

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Fourth Quarter 2022 Financial Results

Revenue for the three months ended December 31, 2022 increased 27.7% to $394.1 million, compared to $308.6 million for the comparable prior-year period. On a constant currency organic basis, revenue for the fourth quarter of 2022 increased 28.9% compared to the fourth quarter of 2021.

Backlog as of December 31, 2022 increased 17.2% to $2,339.6 million from $1,997.1 million as of December 31, 2021. Net new business awards were $485.1 million, representing a net book-to-bill ratio of 1.23x for the fourth quarter of 2022, as compared to $458.7 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the fourth quarter of 2022, total direct costs were $278.4 million, compared to total direct costs of $220.6 million in the fourth quarter of 2021. Selling, general and administrative (SG&A) expenses were $33.4 million in the fourth quarter of 2022, compared to SG&A expenses of $27.7 million in the fourth quarter of 2021.

GAAP net income for the fourth quarter of 2022 was $68.7 million, or $2.12 per diluted share, versus GAAP net income of $50.0 million, or $1.32 per diluted share, for the fourth quarter of 2021. This resulted in a net income margin of 17.4% and 16.2% for the fourth quarter of 2022 and 2021, respectively.

EBITDA for the fourth quarter of 2022 increased 30.9% to $80.4 million, or 20.4% of revenue, compared to $61.4 million, or 19.9% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the fourth quarter of 2022 increased 23.3% from the fourth quarter of 2021.

Full Year 2022 Financial Results

Revenue for the year ended December 31, 2022 increased 27.8% to $1,460.0 million, compared to $1,142.4 million for the year ended December 31, 2021. On a constant currency organic basis, revenue increased 29.2% for the year ended December 31, 2022 compared to the year ended December 31, 2021.

For the year ended December 31, 2022, net new business awards were $1,829.5 million, representing a net book-to-bill ratio of 1.25x, compared to $1,610.4 million for the year ended December 31, 2021.

For the full year 2022, total direct costs were $1,027.6 million, compared to $814.2 million in the full year 2021. For the full year 2022, SG&A expenses were $131.4 million, compared to $108.4 million for the full year 2021.

GAAP net income for the full year 2022 was $245.4 million, or $7.28 per diluted share, versus GAAP net income of $181.8 million, or $4.81 per diluted share, for the full year 2021. This resulted in a net income margin of 16.8% and 15.9% for the full year 2022 and 2021, respectively.

EBITDA for the full year 2022 increased 38.1% to $308.1 million, or 21.1% of revenue, compared to $223.1 million, or 19.5% of revenue, for the prior year. On a constant currency basis, EBITDA increased 32.3% for the full year 2022 compared to the full year 2021.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA and EBITDA margin to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $28.3 million at December 31, 2022, and the Company generated $136.7 million in cash flow from operating activities during the fourth quarter of 2022. The Company paid $89.7 million against the credit facility during the fourth quarter of 2022. Short-term debt was $50.0 million at December 31, 2022.

During the fourth quarter of 2022, the Company repurchased 228,247 shares at an average price of $206.68 per share for a total of $47.2 million. For the full year 2022, the Company repurchased approximately 5.7 million shares for $847.7 million. As of December 31, 2022, the Company had $452.8 million remaining under its authorized share repurchase program.

2023 Financial Guidance

The Company forecasts 2023 revenue in the range of $1.690 billion to $1.750 billion, representing growth of 15.8% to 19.9% over 2022 revenue of $1.460 billion. GAAP net income for full year 2023 is forecasted in the range of $245.0 million to $265.0 million. Additionally, full year 2023 EBITDA is expected in the range of $325.0 million to $350.0 million. Based on forecasted 2023 revenue of $1.690 billion to $1.750 billion and GAAP net income of $245.0 million to $265.0 million, diluted earnings per share (GAAP) is forecasted in the range of $7.53 to $8.14. This guidance assumes a full year 2023 tax rate of 17.5% to 18.5% and does not reflect the potential impact of any share repurchases the Company may make pursuant to the share repurchase program after December 31, 2022.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, February 14, 2023, to discuss its fourth quarter and full year 2022 results.

To participate in the conference call, interested parties must register in advance by clicking on this link. While it is not required, it is recommended you join 10 minutes prior to the event start. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique PIN that can be used to access the call.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call. A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

On February 13, 2023 SOPHiA GENETICS SA (Nasdaq: SOPH), the creator of a leading cloud-native global data-sharing network and health analytics platform,reported that it is partnering with AstraZeneca (LSE/STO/Nasdaq: AZN) to apply their multimodal technology and expertise to the biopharmaceutical company’s oncology portfolio (Press release, Sophia Genetics, FEB 13, 2023, View Source [SID1234627140]). The multimodal approach will go beyond a single data modality, combining radiomics analysis of medical imaging data, molecular data, digital pathology, clinical and biologic data for a more comprehensive assessment of multimodal signatures leveraging proprietary AI and machine learning technology. Together, the companies will examine ways to accelerate clinical trials, support evidence generation for market access, and improve clinical decision-making, helping clinicians to select the best possible treatments.

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SOPHiA GENETICS is able to support this vision in practice today. In parallel, SOPHiA GENETICS launched its own real-world DEEP-Lung-IV clinical study to leverage its multimodal machine learning-powered analytics capabilities to identify multimodal predictive signatures of response to immunotherapy for patients with advanced lung cancer.

"AstraZeneca is a global leader in innovative oncology therapeutics and has built one of the most diverse and robust oncology portfolios and R&D pipelines in the industry. Building on our existing partnership with AstraZeneca, notably to expand access to HRD testing, we are incredibly excited to deepen our collaboration to multimodal approaches that will further enable their precision oncology capabilities," said Peter Casasanto, Chief BioPharma Officer of SOPHiA GENETICS.

"We see AstraZeneca as a visionary partner willing to invest in the next generation of data sciences and technology capabilities at scale to usher in a new area of data-driven medicine. We are incredibly excited to further integrate science and technology in our joint pursuit of transformative impact on patient outcomes," said Dr. Philippe Menu, Chief Medical Officer SOPHiA GENETICS.

"Multimodality aims to harness the power of advanced AI and machine learning models by integrating multiple data modalities to obtain key insights which inform prognosis and response to therapy at the individual patient level. This approach is synergistic with AstraZeneca’s focus on developing personalized cancer treatment and has the potential to elevate precision oncology, currently driven by genomic-based biomarkers, into a truly multimodal connected health ecosystem," said Greg Rossi, Senior Vice President, Oncology Europe & Canada, AstraZeneca.

On February 13, 2023 Onco360, the nation’s leading independent Specialty Pharmacy, reported that it has been selected by Taiho Oncology to be a specialty pharmacy partner for Lytgobi (futibatinib), which is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearranagements (Press release, Onco360, FEB 13, 2023, View Source [SID1234627138]). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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"Onco360 is honored to partner with Taiho Oncology and become a specialty pharmacy provider for Lytgobi patients," said Benito Fernandez, Chief Commercial Officer, Onco360. "We are committed to supporting the highly specialized needs of patients battling treatment-experienced, FGFR2-mutant, advanced cholangiocarcinoma patients across the United States."

According to the American Cancer Society (ACS), it is estimated that 8,000 patients will be diagnosed with cholangiocarcinoma annually. The five-year overall survival (OS) for cholangiocarcinoma, regardless of stage, is only 9%. With regard to cholangiocarcinoma patients with distant metastatic disease, the five-year OS is only 2%.1 Approximately 20% of cholangiocarcinoma cases are considered intrahepatic in terms of tumor location.2 10-16% of intrahepatic cholangiocarcinoma cases have FGFR2 mutations.3

Lytgobi is developed and commercialized by Taiho Oncology. The FDA approval of Lytgobi comes as a result of the Phase I/II, open-label, single-arm TAS-120-101 (NCT02052778) clinical trial which evaluated the use of Lytgobi in previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma patients. The TAS-120-101 demonstrated that Lytgobi administration resulted in a 42% overall response rate (ORR) in 103 study participants.

On February 13, 2023 Cleveland Diagnostics, Inc., a commercial-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported an agreement designed to expand patient access to Cleveland Diagnostics’ novel prostate cancer test, IsoPSA (Press release, Cleveland Diagnostics, FEB 13, 2023, View Source [SID1234627137]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Through an agreement with Quest Diagnostics (NYSE: DGX), the nation’s leading provider of diagnostic information services, patients will be able to access IsoPSA and, once ordered by their physician, provide a blood specimen for testing at one of over 2,100 Quest Diagnostics patient service center locations nationwide later this year. With its national logistics network, Quest will transport the specimens to Cleveland Diagnostics’ laboratory for testing. The parties expect physicians will be able to begin offering the test to patients through Quest Diagnostics in the second quarter of 2023.

IsoPSA is a blood-based prostate cancer test used in triaging patients at risk for high-grade prostate cancer to biopsy. For patients with elevated levels of prostate-specific antigen (PSA), IsoPSA provides additional insight into whether patients’ elevated PSA levels are due to high-grade cancer or a different condition, thereby empowering physicians and patients with insights for deciding whether to undergo prostate biopsy.

PSA is a protein produced by cells of the prostate gland. While the PSA test measures the level of PSA in the blood, which is often elevated in people with prostate cancer, several benign conditions can also cause a person’s PSA level to rise.1 Moreover, PSA testing is unable to identify cases of prostate cancer that may be rapidly progressing and therefore require urgent treatment. By comparison, the IsoPSA test helps predict risk by interrogating the partitioning behavior of isoforms of PSA that are linked to cancer. In a large, prospective, multi-center clinical study, the IsoPSA test demonstrated significant improvement in detecting high grade prostate cancer.2 A separate and robust clinical utility study confirmed that IsoPSA could reduce unnecessary biopsies by as much as 55%.3

"We are very pleased to collaborate with Quest Diagnostics to expand patient access to IsoPSA. We believe Quest’s broad reach and extensive laboratory services expertise will provide patients and their physicians with unparalleled access to transformative clinical insights," said Arnon Chait, CEO of Cleveland Diagnostics. "As the leader in oncology testing, Quest is aligned with Cleveland Diagnostics’ vision of providing physicians and their patients exceptional and more definitive understanding of their prostate conditions."

"Prostate cancer is a leading cause of cancer – and cancer deaths – among men, and physicians are eager for improved tools to diagnose, stage and monitor this disease," said Kristie Dolan, vice president and general manager of Oncology at Quest Diagnostics. "We believe IsoPSA holds great promise to better inform physicians’ diagnostic and treatment decisions for their patients being evaluated for prostate cancer, and we are pleased to work with Cleveland Diagnostics to expand access to this important new test, ultimately bettering patient outcomes by improving the diagnostic process."

According to the American Cancer Society, prostate cancer increased by 3% per year from 2014 through 2019 after two decades of decline, driven primarily by the diagnosis of advanced disease.4 A recent Quest Diagnostics Health Trends study suggests this trend could continue or even worsen: two years after the COVID-19 pandemic began, the rate of new diagnoses of prostate cancer continued to lag behind pre-pandemic levels, suggesting delays in care may contribute to more advanced prostate cancers in the future.

About IsoPSA

IsoPSA is a non-invasive, blood-based test that demonstrated in a large, multicenter study superior diagnostic accuracy compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer diagnosis. Cleveland Diagnostics currently offers IsoPSA as a laboratory-developed test conducted at its high-complexity, CLIA-certified, CAP-accredited laboratory in Cleveland, Ohio. For the time being, tests ordered through the Quest network will be processed in Cleveland Diagnostics’ laboratory in Cleveland, OH.

On February 13, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported that it has entered into an exclusive licensing agreement with CSPC Megalith Biopharmaceutical Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093) for development and commercialization of CRB-701 (SYS6002): a novel clinical stage antibody drug conjugate (ADC) targeting Nectin-4 (Press release, Corbus Pharmaceuticals, FEB 13, 2023, View Source [SID1234627136]). The agreement covers exclusive commercialization rights to CRB-701 in the United States, Canada, the European Union (including the European Free Trade Area), the United Kingdom, and Australia. CSPC will retain all rights to SYS6002 in the remaining global markets. The IND for CRB-701 has been cleared by the US FDA. CRB-701 is currently being investigated by CSPC in a Phase 1 dose escalation clinical trial in advanced solid tumors in China. Corbus is planning to bridge data from this Phase 1 trial to support a US clinical trial starting in 2024. Corbus and CSPC will work collaboratively to execute the clinical development of CRB-701 with Corbus responsible for the clinical development in the US and other licensed territories.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"This agreement adds a promising clinical-stage asset with a validated mechanism of action to our pipeline and reinforces the evolution of Corbus into a precision oncology company. We will leverage the R&D infrastructure that we have established for our TGFβ modulator (CRB-601) to also enhance our understanding of Nectin-4," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus. "By combining recent cost-reduction measures as well as prioritization of resources to this new program, we can maintain our previously stated cash runway through the second quarter of 2024."

CSPC will receive an upfront payment of $7.5 million. CSPC will also be eligible to receive royalties on net sales and up to $130 million in potential development and regulatory milestone payments and $555 million in potential commercial milestone payments.

"CRB-701 has several key features that support a differentiated profile," said Rachael Brake, Ph.D., Chief Scientific Officer of Corbus. "These include site specific conjugation chemistry that leads to low payload release in plasma, a novel Fc-enabled antibody with an improved pharmacokinetic profile and toxicology data that suggests that there is an ability to achieve higher exposures with CRB-701. We look forward to working with CSPC to advance clinical development of this asset and realize its full potential."

"This partnership with Corbus, is an example of our focused effort to bring our innovative pipeline overseas to help patients battling cancer. We look forward to collaborating with Corbus with the goal of developing this ADC as a potentially impactful treatment option to patients in need," said Zhang Cuilong, Chief Executive Officer of CSPC.

Reverse Stock Split

Concurrent with the licensing agreement, Corbus also announced a 1-for-30 reverse stock split of its common stock, effective on February 14, 2023. Beginning on February 14, 2023, the Company’s common stock will continue to trade on The Nasdaq Capital Market on a reverse split adjusted basis under the trading symbol ‘CRBP’, but will trade under the following CUSIP number: 21833P301. The reverse stock split was approved by Corbus stockholders on December 20th and is intended to increase the Company’s stock price to regain compliance with the $1.00 minimum bid price requirement of The NASDAQ Capital Market. Upon effectiveness of the reverse stock split, every thirty shares of common stock issued and outstanding will be automatically converted into one share of Corbus common stock, with no corresponding reduction in the number of authorized shares of the common stock. Any fraction of a share of common stock that would be created will be paid out to stockholders in cash equal to such fraction multiplied by the average of the closing sales prices of the common stock on The Nasdaq Capital Market for the five consecutive trading days immediately preceding the effective date of the reverse split, adjusted to give effect to the 1-for-30 reverse split.

For additional information on the reverse stock split, please refer to Corbus’ Current Report on Form 8-K filed today, February 13, 2023.