On February 21, 2023 Pacira BioSciences, Inc. (NASDAQ:PCRX) reported that it will report its fourth quarter and year ended December 31, 2022 financial results before the open of the U.S. markets on Tuesday, February 28, 2023 (Press release, Pacira Pharmaceuticals, FEB 21, 2023, View Source [SID1234627475]). Following the release, the company will host a live conference call and webcast at 8:30 a.m. ET.

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For listeners who wish to participate in the question and answer session via telephone, please pre-register here. All registrants will receive dial-in information and a PIN allowing them to access the live call. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com. For those unable to participate in the live call, a replay of the webcast will be available on the Pacira website for approximately two weeks following the call.

On February 21, 2023 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its fourth quarter and full year 2022 financial results on Tuesday, February 28, 2023 and will provide a business update (Press release, Altimmune, FEB 21, 2023, View Source [SID1234627474]).

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Altimmune management will host a conference call at 8:30 am E.T. on February 28 to discuss financial results and provide a business update. The conference call will be webcast live on Altimmune’s Investor Relations website at View Source

Participants who would like to join the call may register here to receive the dial-in numbers and unique PIN to access the call. Shortly after the call, a replay will be available on the Investor Relations website for up to twelve months.

On February 21, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a corporate update (Press release, BioCryst Pharmaceuticals, FEB 21, 2023, https://ir.biocryst.com/news-releases/news-release-details/biocryst-reports-fourth-quarter-and-full-year-2022-financial [SID1234627473]).

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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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"It has been exciting to build on our strong initial launch by doubling ORLADEYO revenues in our second year, and to see the expanding global reach of an oral, once-daily therapy that is changing the lives of patients with HAE and their families," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

ORLADEYO net revenue in the fourth quarter of 2022 was $70.7 million.

New patient demand for ORLADEYO was strong in the fourth quarter, consistent with the steady growth trajectory observed since launch.

The ORLADEYO prescriber base continues to grow significantly, with approximately half of new prescriptions in the fourth quarter coming from the top 500 prescribers.

The total number of patients on ORLADEYO at year-end 2022 was consistent with the company’s expectations.

The company expects patient growth in Q1 2023 to remain strong. Because of typical first quarter requirements from payors for prescription reauthorization of specialty products, like ORLADEYO, that can temporarily move patients from paid drug to free product, copayment assistance and Medicare D cost sharing dynamics, the company expects ORLADEYO net revenue in Q1 2023 to be similar to, or slightly less than, Q4 2022. The company has accounted for this expected Q1 impact in its expectation that full year 2023 ORLADEYO global net revenues will grow to no less than $320 million.

The Canadian Agency for Drugs and Technologies in Health Canadian Drug Expert Committee has recently issued a final draft positive recommendation for ORLADEYO to be reimbursed for the routine prevention of HAE attacks in adults and pediatric patients 12 years of age and older.
"Underlying demand from patients and physicians for ORLADEYO continues to be strong and consistent in the U.S. and our initial European launches are gaining traction with ORLADEYO now commercially available in 15 countries. All of this enables more and more patients to benefit from ORLADEYO, which is on a trajectory to achieve $1 billion in peak sales," said Charlie Gayer, chief commercial officer of BioCryst.

Complement Inhibitor Program

In January 2023, the company announced that initial data from ongoing phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trials in healthy volunteers showed rapid, sustained and >97 percent suppression of the alternative pathway (AP) of the complement system 24 hours following a single 110 mg dose, and that BCX10013 has been safe and generally well-tolerated at all doses studied to date. Recent dose-related observations in an ongoing BCX10013 nonclinical study will delay the clinical program.

In addition to BCX10013, which targets Factor D in the alternative pathway of complement, BioCryst also announced that the company is pursuing oral medicines directed at other targets across the classical, lectin and terminal pathways of the complement system, including C2, a critical upstream serine protease enzyme for activation of the classical and lectin pathways. The company has developed potent, selective molecules targeting C2, which are currently in lead optimization.
Fourth Quarter 2022 Financial Results

For the three months ended December 31, 2022, total revenues were $79.5 million, compared to $47.2 million in the fourth quarter of 2021 (+68 percent year-over-year). The increase was primarily due to $70.7 million in ORLADEYO net revenue in the fourth quarter of 2022, in addition to $8.7 million of net revenue from Rapivab related sales.

Research and development (R&D) expenses for the fourth quarter of 2022 increased to $73.2 million from $63.5 million in the fourth quarter of 2021 (+15 percent year-over-year), primarily due to increased investment in our complement inhibitor program, including accelerated expenses related to the termination of BCX9930.

Selling, general and administrative (SG&A) expenses for the fourth quarter of 2022 increased to $50.2 million, compared to $35.4 million in the fourth quarter of 2021 (+42 percent year-over-year). The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.

Interest expense was $26.5 million in the fourth quarter of 2022, compared to $18.8 million in the fourth quarter of 2021. The increase was due to service on the company’s royalty and debt financing agreements.

Net loss for the fourth quarter of 2022 was $71.5 million, or $0.38 per share, compared to a net loss of $17.8 million, or $0.10 per share, for the fourth quarter of 2021. Non-GAAP net loss for the fourth quarter of 2021 was $73.6 million, or $0.40 per share when excluding the one-time non-cash gain of $55.8 million related to the extinguishment of the non-recourse PhaRMA notes. A reconciliation between GAAP and non-GAAP net loss is provided in the table below.

Cash, cash equivalents, restricted cash and investments totaled $443.9 million as of December 31, 2022, compared to $517.8 million as of December 31, 2021. Operating cash use for the fourth quarter of 2022 was $18.8 million.

Full Year 2022 Financial Results

For the full year ended December 31, 2022, total revenues were $270.8 million, compared to $157.2 million in the full year ended December 31, 2021 (+72 percent year-over-year). The increase was primarily due to $251.6 million of ORLADEYO net revenue in 2022.

R&D expenses in full year 2022 increased to $253.3 million from $208.8 million in full year 2021 (+21 percent year-over-year), primarily due to increased investment in our compliment inhibitor program, and an increase in other research, preclinical and development activities.

SG&A expenses in full year 2022 increased to $159.4 million, compared to $118.8 million in full year 2021 (+34 percent year-over-year). The increase was primarily due to increased investment to support the U.S. commercial launch of ORLADEYO and expanded international operations.

Interest and other income was $5.1 million in full year 2022, compared to $0.1 million in full year 2021. The increase was primarily due to increased interest income, driven by interest rate increases over the course of the year.

Interest expense was $99.1 million in full year 2022, compared to $59.3 million in full year 2021. The increase was due to service on the company’s royalty and debt financing agreements.

A one-time non-cash gain of $55.8 million on extinguishment of debt was recognized in full year 2021 related to the write-off of the non-recourse PhaRMA notes and related accrued interest payable.

Net loss for full year 2022 was $247.1 million, or $1.33 per share, compared to a net loss of $184.1 million, or $1.03 per share, for full year 2021. Non-GAAP net loss for full year 2021 was $239.9 million, or $1.34 per share when excluding the one-time gain on the extinguishment of the non-recourse PhaRMA notes. A reconciliation between GAAP and non-GAAP net loss is provided in the table below.

Non-GAAP Pro forma Financial Measures

The information furnished in this release includes non-GAAP pro forma financial measures that differ from measures calculated in accordance with generally accepted accounting principles in the United States of America ("GAAP"), including financial measures labeled as "non-GAAP" or "adjusted."

We believe providing these non-GAAP measures, which show our pro forma results with these items adjusted, is valuable and useful since they allow the company and investors to better understand the company’s financial performance in the absence of these one-time events and allowed investors to more accurately understand our 2021 results and more easily compare them to future results. These non-GAAP pro forma measures also correspond with the way we expected Wall Street analysts to compare our results. Our non-GAAP pro forma measures should be considered only as supplements to, and not as substitutes for or in isolation from, our other measures of financial information prepared in accordance with GAAP, such as GAAP revenue, operating income, net income, and earnings per share.

Our references to our fourth quarter 2021 and full year 2021 "non-GAAP pro forma" financial measures of adjusted net loss and adjusted earnings per share constitute non-GAAP financial measures. They refer to our GAAP results, adjusted to show the results without the one-time gain realized by the extinguishment of the debt from our PhaRMA notes.

Financial Outlook for 2023

The company expects full year 2023 global net ORLADEYO revenue to be no less than $320 million. As in 2022, due to the seasonal impact of managed care reauthorizations in the first quarter of the year, the company expects ORLADEYO net revenue in the first quarter of 2023 to be similar to, or slightly less than, ORLADEYO net revenue in the fourth quarter of 2022.

Operating expenses for full year 2023, not including non-cash stock compensation, are expected to be flat to 2022 at approximately $375 million. While flat year over year, we expect reductions in R&D spending in 2023 following the discontinuation of the BCX9930 and BCX9250 programs in 2022 and the delay in the 10013 clinical program, offset by increases in SG&A to support the U.S. launch and global expansion of ORLADEYO.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 1-866-777-2509 for domestic callers and 1-412-317-5413 for international callers. A live webcast and replay of the call will be available online at the investors section of the company website at www.biocryst.com.

On February 21, 2023 Exact Sciences Reported record revenue, expects revenue of $2,265-2,315 million and positive adjusted EBITDA for full year 2023 (Press release, Exact Sciences, FEB 21, 2023, View Source [SID1234627471]).

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Fourth quarter and 2022 highlights

Total fourth quarter revenue of $553 million, an increase of 17% or 28% excluding COVID-19 testing, with Screening revenue of $404 million and Precision Oncology revenue of $143 million
Total 2022 revenue of $2,084 million, an increase of 18% or 25% excluding COVID-19 testing, with Screening revenue of $1,425 million and Precision Oncology revenue of $601 million
Surpassed 12 million cumulative people tested for cancer, including 10 million with Cologuard
MADISON, Wis., Feb. 21, 2023 /PRNewswire/ — Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $553.0 million for the fourth quarter of 2022 and $2,084.3 million for the full year of 2022, both ended Dec. 31, 2022.

"With a strong finish in 2022 and a great start to 2023, Cologuard and Oncotype DX are setting the tone for an impactful year ahead," said Kevin Conroy, chairman and CEO of Exact Sciences. "Our financial strength, scientific capabilities, and deep partnerships with health systems put Exact Sciences in a leading position to deliver innovative tests that help prevent cancer, detect it earlier, and guide treatment to more patients globally."

Fourth quarter 2022 financial results

For the three-month period ended Dec. 31, 2022, as compared to the same period of 2021 (where applicable):

Total revenue was $553.0 million, an increase of 17 percent, or 28 percent excluding COVID-19 testing
Screening revenue was $403.5 million, an increase of 45 percent, or 42 percent excluding the PreventionGenetics acquisition
Precision Oncology revenue was $143.4 million, a decrease of 4 percent, or an increase of 1 percent excluding the divested Oncotype DX Genomic Prostate Score test and a $1.8 million foreign exchange impact
COVID-19 testing revenue was $6.0 million, a decrease of 87 percent
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73 percent
Net loss was $127.7 million, or $0.72 per share, compared to a net loss of $220.6 million, or $1.28 per share
EBITDA was $(75.0) million and adjusted EBITDA was $4.9 million
Cash, cash equivalents, and marketable securities were $632.1 million at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests, PreventionGenetics, and immaterial revenue from Biomatrica and Oncoguard Liver products. Precision Oncology includes laboratory service revenue from global Oncotype DX products and therapy selection products.

2023 revenue outlook

The company anticipates revenue of $2,265-$2,315 million during 2023, assuming:

Screening revenue of $1,660-$1,690 million,
Precision Oncology revenue of $600-$620 million, and
COVID-19 testing revenue of $5 million
Non-GAAP disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, non-GAAP gross margin, non-GAAP gross profit, and normalized and constant currency growth rates in revenue. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Normalized and constant currency growth rates in revenue are calculated to adjust for acquisitions, divestitures and foreign currency. To exclude the impact of change in currency exchange rates from the prior period under comparison, the Company converts the current period non-U.S. dollar denominated revenue using the prior period exchange rate. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. Additionally, adjusted EBITDA excludes a number of expense items that are included in net loss. As a result, positive adjusted EBITDA may be achieved while a significant net loss persists. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations." Information reconciling forward-looking non-GAAP measures to U.S. GAAP measures is not available without unreasonable effort.

Fourth quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, February 21, 2023, at 5 p.m. ET to discuss fourth quarter and full year 2022 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuardtest.com. Rx only.

About Exact Sciences’ Precision Oncology portfolio
Exact Sciences’ Precision Oncology portfolio delivers actionable genomic insights to inform prognosis and cancer treatment after a diagnosis. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. The Oncotype DX test is recognized as the standard of care and is included in all major breast cancer treatment guidelines. The OncoExTra test applies comprehensive tumor profiling, utilizing whole exome and whole transcriptome sequencing, to aid in therapy selection for patients with advanced, metastatic, refractory, relapsed, or recurrent cancer. With an extensive panel of approximately 20,000 genes and 169 introns, the OncoExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. Exact Sciences enables patients to take a more active role in their cancer care and makes it easy for providers to order tests, interpret results, and personalize medicine by applying real-world evidence and guideline recommendations. To learn more, visit precisiononcology.exactsciences.com.

About PreventionGenetics
Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome and whole exome sequencing test, PGxome. PreventionGenetics was acquired by Exact Sciences in December 2021.

On February 21, 2023 Kinnate Biopharma Inc. (Nasdaq: KNTE) ("Kinnate"), a clinical-stage precision oncology company, reported that it has acquired ownership stake of Kinnjiu Biopharma Inc. ("Kinnjiu") previously held by the Series A investors using a combination of Kinnate shares and cash (Press release, Kinnate Biopharma, FEB 21, 2023, View Source [SID1234627465]). Kinnate retains Kinnjiu’s cash, intellectual property and other assets, including key personnel and the legal entity structure. The transaction does not impact Kinnate’s cash runway, with current cash, cash equivalents and investments expected to fund current operations into mid-2024. The company also announced that KN-8701, a Phase 1 clinical trial evaluating its pan-RAF inhibitor, exarafenib, was initiated in the People’s Republic of China (PRC), with trial sites now open in PRC and Taiwan.

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Nima Farzan, chief executive officer, Kinnate Biopharma Inc., commented, "We believe retaining the Kinnjiu structure will enable Kinnate to continue to invest in innovation and clinical development of its kinase inhibitors in the People’s Republic of China, Hong Kong, Macau and Taiwan. We are pleased with the progress to date across our programs, including initiating our Phase 1 clinical trial for exarafenib in the region, with sites now open in People’s Republic of China and Taiwan, and initiating the Phase 1 trial for KIN-3248, our pan-FGFR inhibitor, in Taiwan. We plan to continue advancing our novel targeted oncology pipeline globally."

Transaction Background and Terms

Kinnjiu was formed in 2021 as part of Kinnate’s joint venture to develop and commercialize its most advanced kinase inhibitors in the PRC, Hong Kong, Macau and Taiwan. In the transaction, Kinnate purchased all issued and outstanding Series A preferred shares of Kinnjiu from funds affiliated with OrbiMed and Foresite Capital Management for $24 million, using a combination of cash and shares of common stock of Kinnate. The transaction was approved by the independent directors of Kinnate.

KN-8701 Clinical Trial Background

KN-8701 is an ongoing, global Phase 1 clinical trial (NCT04913285) evaluating exarafenib in patients with advanced solid tumors harboring BRAF Class I, II and III alterations, and/or who have NRAS mutant melanoma. The trial is enrolling patients at more than 30 sites across the globe. KN-8701 contains a two-part dose escalation: in Part A1, exarafenib is being evaluated as a monotherapy across BRAF alterations and tumor types and Part A2 is evaluating exarafenib in combination with binimetinib, a MEK inhibitor. Part B, dose expansion, will evaluate exarafenib at a selected dose in cancers driven by BRAF Class II or Class III alterations.