On February 24, 2022 -IVERIC bio, Inc. (Nasdaq: ISEE) reported financial and operating results for the fourth quarter and full year ended December 31, 2021 and provided a general business update (Press release, Ophthotech, FEB 24, 2022, View Source [SID1234608979]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In 2021, we successfully achieved a number of major milestones that we believe have laid the groundwork for 2022 to be a banner year for Iveric Bio," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We continue to focus on execution as evidenced by GATHER2, our second Phase 3 clinical trial for Zimura (avacincaptad pegol), a novel complement inhibitor, for the treatment of geographic atrophy (GA), which continues to exceed expectations with a 12-month injection fidelity rate target of greater than 90%, despite a global pandemic. We are excited to be more than 84% complete with year one of the trial, based on the number of scheduled patient visits. We look forward to sharing topline GATHER2 data in the second half of this year, approximately one year after the enrollment of the last patient plus the time needed for database lock and analysis."

"This is a pivotal time for the Company as we continue our internal efforts to prepare for a potential filing of a New Drug Application (NDA) for Zimura for the treatment of GA," stated Pravin U. Dugel, MD, President of Iveric Bio. "We continue to gain momentum in building out our medical affairs and commercial infrastructure as we prepare for the potential launch of Zimura in the US. We plan to initiate a Phase 3 clinical trial studying Zimura in patients with intermediate AMD during the second half of this year. We are pursuing additional lifecycle initiatives, including evaluating multiple sustained-release delivery technologies for Zimura. Further, the U.S. Patent and Trademark Office (USPTO) recently allowed claims for a patent covering methods of treating GA with Zimura, an important addition to our intellectual property portfolio."

Therapeutics Programs Targeting Geographic Atrophy (GA) and other Stages of Age-Related Macular Degeneration (AMD)

Zimura (avacincaptad pegol): Complement C5 Inhibitor

In February 2022, the USPTO allowed claims for methods of using Zimura for the treatment of GA. The patent, when issued, is expected to expire in 2034.
In February 2022, results from a post-hoc analysis that evaluated various GA growth parameters to explore the rate of disease progression within various regions in the fovea in a subset of patients from GATHER1, the Company’s Phase 3 clinical trial for the treatment of Zimura in GA, were presented at the Angiogenesis, Exudation and Degeneration conference. Consistent with the overall results of GATHER1, in the new analysis a reduction in lesion growth in five standardized regions surrounding and including the central foveal area was observed for patients receiving Zimura 2 mg as compared to patients receiving sham over a period of 18 months. We believe the preservation of the central fovea region that was observed in this post-hoc analysis has the potential to be a corollary to a functional benefit.
In July 2021, the Company announced the completion of patient enrollment in GATHER2, four months ahead of the Company’s original schedule.
In July 2021, the Company received a written agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the overall design of GATHER2. The agreement further solidifies the Company’s plans to file an NDA with the FDA for marketing approval of Zimura for GA, if the ongoing GATHER2 clinical trial meets its primary endpoint at 12 months. Zimura met its pre-specified primary efficacy endpoint at 12 months with statistical significance in the previously completed GATHER1 pivotal clinical trial.
In June 2021, the Company announced data from post-hoc analyses from the GATHER1 trial, in which the Company evaluated the progression of incomplete Retinal Pigment Epithelial and Outer Retinal Atrophy (iRORA) to complete Retinal Pigment Epithelial and Outer Retinal Atrophy (cRORA) and the progression of drusen to iRORA or cRORA, in patients receiving Zimura 2 mg as compared to patients in the corresponding sham group. Based on the Company’s hypothesis regarding complement inhibition as a mechanism of action to treat AMD and the results of the analyses, the Company plans to initiate a Phase 3 clinical trial studying Zimura in patients with intermediate AMD in the second half of 2022. The development strategy in this indication is subject to regulatory feedback, which the Company plans to obtain before initiating this trial.
Patient enrollment in STAR, the Company’s Phase 2b screening clinical trial of Zimura for the treatment of autosomal recessive Stargardt disease, is ongoing. The results of this trial are expected after the topline results of GATHER2.
IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor

In 2021, the Company initiated a number of preclinical tolerability and pharmacokinetic studies for IC-500. The Company anticipates that the start of IND-enabling toxicology studies for IC-500 will be later than originally planned, primarily due to the limited availability of study slots at contract research organizations in the wake of the COVID-19 pandemic. The Company expects to submit an investigational new drug application (IND) to the FDA for IC-500 during mid-2023.
Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

As the Company focuses its efforts and resources on the development and potential commercialization of Zimura, the Company is exploring potential collaborations for the future development and potential commercialization of IC-100, the Company’s product candidate for Rhodopsin-Mediated Autosomal Dominant Retinitis Pigmentosa (RHO-adRP) and IC-200, the Company’s product candidate for BEST1-Related IRDs.
In the second half of 2021, the Company transitioned the Stargardt Disease (ABCA4) and USH2A minigene research programs from the University of Massachusetts Medical School (UMMS) to the Company with plans to continue these programs internally. The Company has established a laboratory for continuing the work on its minigene research programs and other preclinical ocular research activities.
Corporate Updates

The Company expanded its Board of Directors and management by adding a number of industry leaders:

Christine Ann Miller, a pharmaceutical veteran, joined the Company’s board of directors in January 2022.
Tony Gibney joined the Company as Executive Vice President and Chief Business and Strategy Officer in December 2021. Mr. Gibney is an experienced biotechnology executive and former investment banker.
Christopher Simms joined the Company as Senior Vice President and Chief Commercial Officer in August 2021. Mr. Simms has commercial leadership experience in retina, ophthalmology, and optometry.
In October 2021, the Company raised approximately $163 million in net proceeds in an underwritten public offering of its common stock. In July 2021, the Company raised approximately $108 million in net proceeds in an underwritten public offering of its common stock.

Fourth Quarter and Year Ended 2021 Operational Update and 2022 Cash Guidance

As of December 31, 2021, the Company had approximately $381.7 million in cash, cash equivalents and marketable securities.
The Company estimates its year-end 2022 cash, cash equivalents and marketable securities will range between $215 million and $225 million. The Company also estimates that its cash, cash equivalents and available for sale securities will be sufficient to fund its planned capital expenditure requirements and operating expenses through at least mid-2024. These estimates are based on the Company’s current business plan, including the continuation of its ongoing clinical development programs for Zimura in GA and STGD1 and the initiation of an intermediate AMD clinical trial, preparation and potential filing of an NDA and a MAA for Zimura in GA, continuing preparations for potential commercial launch of Zimura in GA, investing in sustained release delivery technologies for Zimura, and the advancement of its IC-500 development program. Excluded from these estimates are any potential approval or sales milestones payable to Archemix Corp. or any potential expenses for actual commercial launch of Zimura, such as associated sales force expenses, any additional expenditures related to potentially studying Zimura in indications outside of GA, STGD1 and intermediate AMD, or resulting from the potential in-licensing or acquisition of additional product candidates or technologies, or any associated development the Company may pursue.
2021 Q4 Financial Highlights

R&D Expenses: Research and development expenses were $25.1 million for the quarter ended December 31, 2021, compared to $17.5 million for the same period in 2020. For the year ended December 31, 2021, research and development expenses were $85.1 million compared to $62.8 million for the same period in 2020. Research and development expenses increased year over year primarily due to the commencement and completion of patient enrollment for the GATHER2 clinical trial, increased manufacturing activities for Zimura and increases in personnel costs, including share-based compensation associated with additional research and development staffing. This increase in costs was partially offset by decreases in costs associated with the Company’s gene therapy programs.
G&A Expenses: General and administrative expenses were $8.0 million for the quarter ended December 31, 2021 and for the same period in 2020. For the year ended December 31, 2021, general and administration expenses were $29.7 million, compared to $26.0 million for the same period in 2020. General and administration expenses increased year over year primarily due to an increase in external costs, including legal and consulting costs associated with litigation, pre-commercialization activities and other administrative costs necessary to support the Company’s operations.
Income Tax Benefit: The Company recorded no income tax benefit for the three months ended December 31, 2021 and 2020 and the year ended December 31, 2021. Income tax benefit of $3.7 million for the year ended December 31, 2020, was recognized to reflect a favorable settlement of a state corporate income tax audit.
Net Loss: The Company reported a net loss for the quarter ended December 31, 2021 of $33.0 million, or ($0.29) per diluted share, compared to a net loss of $25.4 million, or $(0.27) per diluted share, for the same period in 2020. For the year ended December 31, 2021, the Company reported a net loss of $114.5 million or ($1.12) per diluted share, compared to a net loss of $84.5 million or ($1.14) for the same period in 2020.
Conference Call/Web Cast Information
Iveric Bio will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for February 24, 2022 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 8865993. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the Iveric Bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 1-877-344-7529 (USA Toll Free), passcode 8000837.

On February 24, 2022 Oasmia reported Year-end report January 1, 2021 – December 31, 2021 (Press release, Oasmia, FEB 24, 2022, View Source [SID1234608978])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

SIGNIFICANT EVENTS DURING THE FOURTH QUARTER
In October, Oasmia announced a global settlement of all disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement resulted in a negative cashflow of approx. MSEK 25 while having a positive earnings effect of approx. MSEK 33.
In December, Oasmia announced that the transfer of its marketing authorization for Apealea (paclitaxel micellar) to Inceptua AB had received approval from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
With the purpose to finance the continued development of Oasmia and its projects in accordance with its business plan and strategy, the Board of Directors in January, subject to approval by an Extraordinary General Meeting, resolved on a fully secured rights issue of approximately SEK 151 million.
In January Oasmia announced the intention, subject to approval by an Extraordinary General Meeting, to change its name to Vivesto AB.
In January Oasmia announced progress on the development of XR-18 and that the company has identified and synthesized a promising novel candidate for use in the drug delivery platform.
On 21 February an Extraordinary General Meeting approved the Board of Directors’ resolution on 19 January 2022 on a new issue of shares with preferential rights for existing shareholders, and to approve an amendment to the Articles of Association whereby the company’s corporate name is changed to Vivesto AB.
In February Oasmia gave an update on the progress of the SAKK investigator-initiated Phase 1b trial of Docetaxel Micellar in advanced prostate cancer.
FOURTH QUARTER: OCTOBER 1, 2021 – DECEMBER 31, 2021
Consolidated net sales amounted to TSEK 9,639 (131)
Operating profit/loss var TSEK -2,068 (-59,441)
Net profit/loss after tax amounted to TSEK -2,849 (-65,373)
Earnings per share amounted to SEK -0.01 (-0.15)
FINANCIAL YEAR: JANUARY 1, 2021 – DECEMBER 31, 2021
Consolidated net sales amounted to TSEK 26,192 (201,760)
Operating profit/loss var TSEK -128,647 (-44,323)
Net profit/loss after tax amounted to TSEK -132,722 (-57,541)
Earnings per share amounted to SEK -0.30 (-0.13)
CEO REVIEW
The last quarter of 2021 was one of sustained progress towards delivering our goal of transforming the business and laying the groundwork to create a Nordic oncology powerhouse. Much of the important work undertaken in Q4 was announced early in 2022, including plans to secure financing to drive the value in our portfolio, and changing our name to Vivesto AB to mark the completion of our initial transformation and the next phase in our journey.

In January 2022, we announced plans to raise ~SEK 150 million through a fully secured rights issue. This will strengthen our balance sheet and help us achieve potential value inflection points for our existing development programs as well as financing general business operations for 18-24 months. It is a vital steppingstone to secure the short to medium term future of the business and an important initial step towards achieving our broader vision to build our oncology pipeline through in-licensing and M&A – our "string of pearls" strategy.

Our new identity was approved by shareholders at our EGM on 21 February. This marks the completion of the initial phase of transforming the company set out two years ago. Vivesto – from the Spanish word "alive" – was selected after extensive research among the international medical community, patients and investors, who shared our view that it embodies our mission to build a diversified pipeline focused on hard-to-treat and late-stage cancers using different mechanisms of action.

Since I joined Oasmia I have focused on a number of goals to build the foundations for a strong, business and set us up for success:

Rightsizing the Company and terminating commercial drug production
Strengthening the management of our finances
Positioning us an attractive partner for innovative assets and companies
Settling legacy litigation and reducing business risks
Progressing our pipeline and building critical mass in our portfolio.
Rightsizing the Company and terminating commercial drug production
We are now fully focused on product development, having terminated commercial drug production. Our lead program Apealea (paclitaxel micellar) is out-licensed globally through our global strategic partner Elevar Therapeutics and selected partners in key territories. Elevar has assumed responsibility for commercial drug production of Apealea and XR-17 is manufactured by a sub-contractor.

In September 2021 Paclical (Apealea) was out licensed to the Swiss-based FarmaMondo Group for commercialization in Russia and the Commonwealth of Independent States. As a result, marketing authorizations which Oasmia holds in Russia and Kazakhstan have been transferred to FarmaMondo. FarmaMondo has also taken responsibility for all future development and commercialization activities in Russia and the Commonwealth of Independent States.

In Q4 Inceptua, Elevar’s partner in Europe, informed us it had received approval from the European Commission and UK Medicines and Healthcare products Regulatory Agency (MHRA) for transfer of Apealea’s marketing authorization, enabling it to assume full regulatory responsibility for Apealea in the EU, Norway, Iceland, Liechtenstein, and the UK. Inceptua have confirmed their intention to launch Apealea in the UK and Germany in the first half for 2022, which is expected to lead to us receiving the first royalties during the year.

Strengthening the management of our finances
As part of the comprehensive cost control program launched in 2020, we have significantly reduced operating costs during the year, and we have now realized annualized cost savings of more than SEK 100 million since 2020. We have also reduced our so-called "burn rate" and adjusted for a one-time negative cash flow effect in Q4 from settlement of litigation, the average burn rate per month in 2021 amounted to SEK 10 million which then is in the lower part of our target range of SEK 10-12 million per month. These cost savings have enabled us to invest in areas which in the long run can deliver the greatest return, including pipeline development which is critical for our success and future growth.

Positioning us as an attractive partner
We have made significant progress in building our in-house capabilities over the past two years. We now have a team with proven development and regulatory expertise able to take products from early-to late-stage development and potentially through commercialization and partnering. We believe this makes us more attractive to companies with promising assets targeting hard-to-treat and late-stage cancers. We are currently seeking a new oncology-focused Chief Medical Officer following Heidi Ramstad’s decision to leave the company in April for personal reasons. Most recently and post period, Kai Wilkinson, Head of Research & Development and Manufacturing was promoted to the position of Chief Technology Officer and joined Oasmia’s Management team. I look forward to working more closely with Kai. His skills and expertise will be useful as we continue the transform our Technical Operations to support our broader business objectives.

Settling legacy litigation and reducing business risks
During Q4 we announced a global settlement for all inherited outstanding legal disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement resulted in a negative cashflow of approx. MSEK 25 while having a positive earnings effect of approx. MSEK 33. Reported debt in relation to MGC Capital of MSEK 80, as well as a receivable of MSEK 40, was settled as a result of the agreement leading to the positive earnings effect as reported in the income statement for the quarter. This is excellent news and ends a notable risk for the business. Most importantly, this has resulted in Oasmia being debt free, a considerable achievement.

Progressing our pipeline and expanding our portfolio
Cantrixil, the first in-licensed oncology program of our string of pearls strategy, continued to make progress towards a Phase 2 study, building on promising Phase 1 results in late-stage ovarian cancer. Valuable insights provided by our Scientific Advisory Board are helping us to design the Phase 2 trial and the longer-term clinical and regulatory path. We are planning to engage with regulatory authorities this year in preparation for a multi-center Phase 2 study in the US and EU. We have also continued to work on securing manufacturing agreements to ensure drug supply. Our aim is to have made substantial progress by the end of 2022 towards initiating the Phase 2 trial.

A Phase 1b trial of our second clinical-stage program, Docetaxel micellar, in development for advanced prostate cancer, continued to recruit patients in Switzerland under the leadership of the Swiss Group for Clinical Cancer Research (SAKK). SAKK has made excellent progress, with three centers open and enrolment is expected to be completed by the end of 2022. Most recently, post period end in February 2022, we reported that the first patient has now fully completed the study. Furthermore, the first of three dosing groups in the trial has been successfully recruited and the first patient has started in the second dose group.

Over the last year we have completed a significant number of due diligence exercises on public and private companies and in-licensing targets in oncology. In Q4 we continued this work to analyze promising business development opportunities that will leverage our in-house expertise, expand our portfolio of cancer therapies around multiple modalities and create long-term value for shareholders. 2022 should see the materialization of this work and we look forward to updating the market on our progress.

Exploring the full potential of our technologies
Recently and post period we announced progress on the in-house development of XR-18, the next generation of our proprietary drug delivery technology. We believe XR-18 could offer enhanced capabilities compared with XR-17, which is designed to increase the solubility of intravenously delivered compounds and has been used successfully in Apealea. The next-generation formulation applied in XR-18 is already being tested in combination with a widely used oncology compound, and steps for securing Intellectual Property are being taken.

A solid end to the year
We made continued progress towards achieving all our key goals in Q4. With a solid platform for growth, we are fully focused on moving our promising oncology development pipeline forward and continuing to expand our portfolio through our "string of pearls" in-licensing and acquisition strategy to build critical mass and bring innovation to patients with hard-to-treat cancers.

In 2022, we will see Apealea launched in Europe via Elevar’s partner Inceptua. Apealea offers a non cremophor formulation of paclitaxel which may offer substantial benefits to some patients, and this makes us very proud.

On February 24, 2022 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter and year ended Dec. 31, 2021 (Press release, Myriad Genetics, FEB 24, 2022, View Source [SID1234608977]). The company also reiterated financial guidance for 2022 and provided an update on business performance and strategic growth plans.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"With the focus and dedication of our 2,400 teammates, we improved quarterly and annual results despite continued headwinds from the COVID-19 pandemic. I want to thank our entire team for a great year delivering on our mission of advancing the health and well-being of our patients while executing on our transformation and growth plan," said Paul J. Diaz, president and Chief Executive Officer. "In the fourth quarter we gained traction on our new commercial strategy with new product launches, tech-enabled capabilities, and more customer-centric tools that we believe will provide a strong foundation for continued growth and innovation. However, we also saw an adverse impact from the Omicron variant toward the end of 2021 and into the new year, particularly in our hereditary cancer business."

Financial and Operational Highlights:

Diagnostic test volumes in the fourth quarter of 2021 of 237,000 were flat year-over-year and decreased 5% sequentially from the third quarter of 2021. Excluding divested businesses, diagnostic test volumes for the quarter increased 13% year-over-year and 5% sequentially. Sequential volumes were impacted by constraints in access to healthcare providers and staffing challenges due to the COVID-19 pandemic.
Hereditary cancer volumes for the quarter decreased 9% year-over-year and increased 2% sequentially.
Prenatal test volumes in Women’s Health for the quarter increased 4% year-over-year and 3% sequentially.
Tumor profiling test volumes in Oncology for the quarter were flat year-over-year and increased 1% sequentially.
Pharmacogenomics test volumes in Mental Health for the quarter increased 63% year-over-year and 8% sequentially.
Overall, average selling price (ASP) in the fourth quarter of 2021 increased 10% year-over-year and 1% sequentially after excluding positive revenue adjustments related to better-than-expected cash collections on tests ordered in prior periods. Improvements in ASP across Myriad’s product portfolio are primarily due to the benefits realized from investments made in revenue cycle management.
Total revenue in the fourth quarter of 2021 was $160.8 million, an increase of 4% year-over-year.
Excluding the divested business revenue, RBM, Autoimmune and myPath, quarterly revenue increased 19% year-over-year.
The following table summarizes year-over-year quarterly revenue changes by product category (excluding divested assets):

GAAP gross margin in the fourth quarter of 2021 was 71.5%; adjusted gross margin in the quarter was 71.8%, which increased 170 basis points year-over-year and 10 basis points sequentially.
GAAP total operating expenses in the fourth quarter of 2021 were $158.1 million; adjusted operating expenses in the quarter decreased $6.2 million sequentially to $115.3 million.
GAAP operating loss in the fourth quarter of 2021 was $(43.1) million, improving $5.1 million year-over-year; adjusted operating income was $0.1 million, increasing $11.4 million year-over year.
Diluted GAAP EPS in the fourth quarter of 2021 were $(0.10), increasing $0.40 year-over-year; adjusted EPS were $(0.02), increasing $0.10 year-over-year.
Ended the fourth quarter of 2021 with $398.8 million in cash, cash equivalents and investments and no debt outstanding.
Business Performance and Highlights:

Women’s Health
The Myriad Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. Women’s Health delivered revenue of $64.0 million in the fourth quarter of 2021, an increase of 14% year-over-year and an increase of 8% sequentially from the third quarter of 2021.

Hereditary Cancer
The new MyRisk Hereditary Cancer test with RiskScore for all ancestries is part of the company’s mission to increase health equity and make genetic testing more inclusive. Together, MyRisk with RiskScore provides a personalized 5-year and lifetime breast cancer risk assessment for all women, regardless of ancestry – the first of its kind. Myriad Genetics provides a genetically informed breast cancer risk assessment as part of a comprehensive panel – expanding access to genetic testing for more patient populations. More than 91,000 women received a RiskScore assessment in 2021, including over 16,000 women with non-European ancestry.
RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test, and we estimate that more than 56% of women qualify for medical management after the company’s testing compared to 10% with standard hereditary cancer testing.
Prenatal
Myriad Genetics saw another strong quarter from its Prequel noninvasive prenatal screening (NIPS) test including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures.
The company plans to launch a combined prenatal and carrier screening test, FirstGene, in 2023. Delivering the clinical value of both Prequel and Foresight to expecting parents, FirstGene is designed to simplify the NIPS and carrier screening process by requiring only one maternal sample, enabling more patients to get answers faster.
Oncology
Myriad’s Oncology business provides hereditary cancer testing, including MyRisk, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the MyChoice CDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $67.4 million in the fourth quarter of 2021, an increase of 12% year-over-year and a decrease of 12% sequentially from the third quarter of 2021.

In early 2022, Myriad Genetics will launch Precise Tumor for molecular tumor profiling – part of a suite of Precise Oncology Solutions that combines the company’s MyRisk germline hereditary cancer testing technology and its MyChoice CDx companion diagnostic test with a Myriad tumor profiling test powered by Illumina’s TSO500 technology and run by Intermountain Precision Genomics.
With Precise, patients and their healthcare providers will receive one comprehensive solution from one laboratory with one team of scientists interpreting the results, which the company believes significantly improves the quality and ease of use of the results. The combined product offering will be sold through the Myriad Oncology sales force throughout the United States and is expected to be launched this quarter.
Myriad Genetics recently announced plans to develop new genetic testing products for cancer applications in the liquid biopsy Bx and Measurable Residual Disease (MRD) spaces.
The company also announced plans to expand its market leading FDA approved companion diagnostic test, MyChoice CDx, to other indications including breast, prostate and pancreatic cancers for expanded pharma clinical trials and commercial testing.
Mental Health
Myriad’s Mental Health business consists of the GeneSight psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight delivered revenue of $29.4 million in the fourth quarter of 2021, an increase of 63% year-over-year and 22% sequentially from the third quarter of 2021.

GeneSight saw a strong increase in new ordering providers with over 2,900 physicians ordering GeneSight for the first time in the quarter. The total number of ordering physicians increased 7% sequentially. 95% of these providers are ordering through the Company’s new online portal.
GeneSight home-based kits now represent approximately 30% of all orders. This number is expected to increase as telehealth becomes a more common alternative to in-person care and as the company expands its telemedicine partnerships.
The Mental Health business has successfully implemented its ongoing commercial transformation with the rightsizing of its field sales force, growing its inside sales force, and executing a robust digital marketing plan to meet patients and clinicians where they are searching for mental health treatments online. Following its successful use in Mental Health, this model is now being extended to other Myriad business units.
Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2022 financial guidance:

(in millions,
except per
share amounts) Revenue Gross Margins GAAP OPEX Adjusted OPEX GAAP EPS Adjusted EPS
FY 2022 $670 – $700 70% – 72% $556 – $566 $470 – $480 $(0.90) – $(0.70) $0.00 – $0.20
Myriad’s fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the impact of stock-based compensation expense ($36.5 million), non-cash amortization associated with acquisitions ($41.0 million) and special items such as costs related to transformation initiatives ($8.5 million). These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fourth-quarter financial results and fiscal year 2022 financial guidance.

Conference Call and Webcast
A conference call will be held today, Thursday, Feb. 24, 2022, at 4:30 p.m. EST to discuss Myriad’s financial results and business developments for the fourth quarter 2021. The dial-in number for domestic callers is 1-800-926-5188. International callers may dial 1-212-231-2901. All callers will be asked to reference reservation number 22015280. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its fourth quarter and year ended Dec. 31, 2021. The company also reiterated financial guidance for 2022 and provided an update on business performance and strategic growth plans.

"With the focus and dedication of our 2,400 teammates, we improved quarterly and annual results despite continued headwinds from the COVID-19 pandemic. I want to thank our entire team for a great year delivering on our mission of advancing the health and well-being of our patients while executing on our transformation and growth plan," said Paul J. Diaz, president and Chief Executive Officer. "In the fourth quarter we gained traction on our new commercial strategy with new product launches, tech-enabled capabilities, and more customer-centric tools that we believe will provide a strong foundation for continued growth and innovation. However, we also saw an adverse impact from the Omicron variant toward the end of 2021 and into the new year, particularly in our hereditary cancer business."

Financial and Operational Highlights:

Diagnostic test volumes in the fourth quarter of 2021 of 237,000 were flat year-over-year and decreased 5% sequentially from the third quarter of 2021. Excluding divested businesses, diagnostic test volumes for the quarter increased 13% year-over-year and 5% sequentially. Sequential volumes were impacted by constraints in access to healthcare providers and staffing challenges due to the COVID-19 pandemic.
Hereditary cancer volumes for the quarter decreased 9% year-over-year and increased 2% sequentially.
Prenatal test volumes in Women’s Health for the quarter increased 4% year-over-year and 3% sequentially.
Tumor profiling test volumes in Oncology for the quarter were flat year-over-year and increased 1% sequentially.
Pharmacogenomics test volumes in Mental Health for the quarter increased 63% year-over-year and 8% sequentially.
Overall, average selling price (ASP) in the fourth quarter of 2021 increased 10% year-over-year and 1% sequentially after excluding positive revenue adjustments related to better-than-expected cash collections on tests ordered in prior periods. Improvements in ASP across Myriad’s product portfolio are primarily due to the benefits realized from investments made in revenue cycle management.
Total revenue in the fourth quarter of 2021 was $160.8 million, an increase of 4% year-over-year.
Excluding the divested business revenue, RBM, Autoimmune and myPath, quarterly revenue increased 19% year-over-year.
The following table summarizes year-over-year quarterly revenue changes by product category (excluding divested assets):

GAAP gross margin in the fourth quarter of 2021 was 71.5%; adjusted gross margin in the quarter was 71.8%, which increased 170 basis points year-over-year and 10 basis points sequentially.
GAAP total operating expenses in the fourth quarter of 2021 were $158.1 million; adjusted operating expenses in the quarter decreased $6.2 million sequentially to $115.3 million.
GAAP operating loss in the fourth quarter of 2021 was $(43.1) million, improving $5.1 million year-over-year; adjusted operating income was $0.1 million, increasing $11.4 million year-over year.
Diluted GAAP EPS in the fourth quarter of 2021 were $(0.10), increasing $0.40 year-over-year; adjusted EPS were $(0.02), increasing $0.10 year-over-year.
Ended the fourth quarter of 2021 with $398.8 million in cash, cash equivalents and investments and no debt outstanding.
Business Performance and Highlights:

Women’s Health
The Myriad Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. Women’s Health delivered revenue of $64.0 million in the fourth quarter of 2021, an increase of 14% year-over-year and an increase of 8% sequentially from the third quarter of 2021.

Hereditary Cancer
The new MyRisk Hereditary Cancer test with RiskScore for all ancestries is part of the company’s mission to increase health equity and make genetic testing more inclusive. Together, MyRisk with RiskScore provides a personalized 5-year and lifetime breast cancer risk assessment for all women, regardless of ancestry – the first of its kind. Myriad Genetics provides a genetically informed breast cancer risk assessment as part of a comprehensive panel – expanding access to genetic testing for more patient populations. More than 91,000 women received a RiskScore assessment in 2021, including over 16,000 women with non-European ancestry.
RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test, and we estimate that more than 56% of women qualify for medical management after the company’s testing compared to 10% with standard hereditary cancer testing.
Prenatal
Myriad Genetics saw another strong quarter from its Prequel noninvasive prenatal screening (NIPS) test including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures.
The company plans to launch a combined prenatal and carrier screening test, FirstGene, in 2023. Delivering the clinical value of both Prequel and Foresight to expecting parents, FirstGene is designed to simplify the NIPS and carrier screening process by requiring only one maternal sample, enabling more patients to get answers faster.
Oncology
Myriad’s Oncology business provides hereditary cancer testing, including MyRisk, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the MyChoice CDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $67.4 million in the fourth quarter of 2021, an increase of 12% year-over-year and a decrease of 12% sequentially from the third quarter of 2021.

In early 2022, Myriad Genetics will launch Precise Tumor for molecular tumor profiling – part of a suite of Precise Oncology Solutions that combines the company’s MyRisk germline hereditary cancer testing technology and its MyChoice CDx companion diagnostic test with a Myriad tumor profiling test powered by Illumina’s TSO500 technology and run by Intermountain Precision Genomics.
With Precise, patients and their healthcare providers will receive one comprehensive solution from one laboratory with one team of scientists interpreting the results, which the company believes significantly improves the quality and ease of use of the results. The combined product offering will be sold through the Myriad Oncology sales force throughout the United States and is expected to be launched this quarter.
Myriad Genetics recently announced plans to develop new genetic testing products for cancer applications in the liquid biopsy Bx and Measurable Residual Disease (MRD) spaces.
The company also announced plans to expand its market leading FDA approved companion diagnostic test, MyChoice CDx, to other indications including breast, prostate and pancreatic cancers for expanded pharma clinical trials and commercial testing.
Mental Health
Myriad’s Mental Health business consists of the GeneSight psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight delivered revenue of $29.4 million in the fourth quarter of 2021, an increase of 63% year-over-year and 22% sequentially from the third quarter of 2021.

GeneSight saw a strong increase in new ordering providers with over 2,900 physicians ordering GeneSight for the first time in the quarter. The total number of ordering physicians increased 7% sequentially. 95% of these providers are ordering through the Company’s new online portal.
GeneSight home-based kits now represent approximately 30% of all orders. This number is expected to increase as telehealth becomes a more common alternative to in-person care and as the company expands its telemedicine partnerships.
The Mental Health business has successfully implemented its ongoing commercial transformation with the rightsizing of its field sales force, growing its inside sales force, and executing a robust digital marketing plan to meet patients and clinicians where they are searching for mental health treatments online. Following its successful use in Mental Health, this model is now being extended to other Myriad business units.
Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2022 financial guidance:

(in millions,
except per
share amounts) Revenue Gross Margins GAAP OPEX Adjusted OPEX GAAP EPS Adjusted EPS
FY 2022 $670 – $700 70% – 72% $556 – $566 $470 – $480 $(0.90) – $(0.70) $0.00 – $0.20
Myriad’s fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the impact of stock-based compensation expense ($36.5 million), non-cash amortization associated with acquisitions ($41.0 million) and special items such as costs related to transformation initiatives ($8.5 million). These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fourth-quarter financial results and fiscal year 2022 financial guidance.

Conference Call and Webcast
A conference call will be held today, Thursday, Feb. 24, 2022, at 4:30 p.m. EST to discuss Myriad’s financial results and business developments for the fourth quarter 2021. The dial-in number for domestic callers is 1-800-926-5188. International callers may dial 1-212-231-2901. All callers will be asked to reference reservation number 22015280. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

On February 24, 2022 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the full year 2021 (Press release, Morphic Therapeutic, FEB 24, 2022, View Source [SID1234608976]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

2021 and Recent Corporate Highlights
•Presented positive phase 1 data supporting MORF-057’s target product profile as an oral bioavailable, potent and specific inhibitor of the α4β7 integrin at the European Crohn’s and Colitis Organisation (ECCO) Virtual Congress 2021
◦MORF-057 was well tolerated in all dose cohorts with no safety signals observed
◦Pharmacokinetic and pharmacodynamic data strongly supported MORF-057 progression into phase 2 with an oral twice daily dosing profile
◦Saturation (>99%) of the α4β7 receptor was observed in all subjects at all timepoints at trough concentrations using 100mg BID, our Ph2a dose
◦T-Cell concentration changes provided further evidence for MORF-057’s ability to replicate the known mechanism of the approved therapeutic, vedolizumab
◦Phase 2a trial of MORF-057 in patients with moderate to severe ulcerative colitis expected to begin in the first quarter of 2022 and Phase 2b to begin mid-year 2022
•Presented positive preclinical data from Morphic’s immuno-oncology program at the AACR (Free AACR Whitepaper) Annual Meeting 2021 demonstrating that potent and specific inhibition of αvβ8, in combination with checkpoint inhibitors, potentiated anti-tumor activity in tumors refractory to checkpoint inhibition monotherapy
◦Additional preclinical data presented at the SITC (Free SITC Whitepaper) Annual Meeting in November 2021 provided further rationale to explore αvβ8 inhibition in combination with immunotherapy to drive anti-tumor responses and survival benefits
•Focused research and development collaboration efforts with AbbVie and Janssen on higher-potential integrin targets in multiple therapeutic areas
◦The Janssen collaboration is now primarily focused on discovering activators of a specific integrin target, including antibody activators
◦Development activities by AbbVie for the αVβ6 target have been discontinued while research activities in the AbbVie collaboration continue on separate integrin targets
•Completed $245 million upsized public offering of common stock providing cash runway until the end of 2024
•Appointed Susannah Gray, a veteran leader in healthcare finance and strategy with three decades of experience, and Nisha Nanda, Ph.D., an experienced leader in preclinical and clinical-stage development strategy across multiple therapeutic areas, to the Morphic Board of Directors
•Thanked Nilesh Kumar, Ph.D., for his leadership and support as member of the Morphic Board of Director as he steps down from his role
◦Dr. Kumar has served as a Director of Morphic since 2017 when he was a Partner at Novo Ventures and Novo Ventures invested in Morphic as private company
◦Dr. Kumar has elected to transition off the Morphic Board of Directors after his transition from Novo Ventures to a new investment firm

"Morphic achieved each of its critical goals in 2021, and MORF-057 in particular significantly outpaced our expectations. The results from our Phase 1 studies with MORF-057 validate our proprietary MInT platform and have elevated our confidence as we embark on the global phase 2 clinical program in ulcerative colitis. We also presented exciting results from our immuno-oncology program demonstrating that αvβ8 inhibition, in combination with checkpoint inhibitors, has great potential to drive responses in checkpoint-refractory tumors," said Praveen Tipirneni, M.D., President and Chief Executive Officer of Morphic Therapeutic.

Financial Results for the full year 2021

•Net loss for the year ended December 31, 2021 was $95.5 million or $2.67 per share compared to a net loss of $45.0 million or $1.47 per share for the year ended December 31, 2020
•Revenue was $19.8 million for the year ended December 31, 2021, compared to $44.9 million for the year ended December 31, 2020. The decrease was mainly due to AbbVie’s option exercise on our αvβ6 integrin inhibitor program in the third quarter of 2020 for $20 million
•Research and development expenses were $87.8 million for the year ended December 31, 2021, as compared to $73.6 million for the year ended December 31, 2020. The increase was primarily attributable to higher manufacturing and development costs along with higher pre-clinical and clinical trial costs to support our lead product candidate MORF-057
•General and administrative expenses were $27.8 million for the year ended December 31, 2021, compared to $18.5 million for the year ended December 31, 2020. The increase was due to increased headcount and higher professional and consulting costs associated with ongoing business development activities and Morphic operating as a public company

As of December 31, 2021, Morphic had cash, cash equivalents and marketable securities of $408.1 million, compared to $228.3 million as of December 31, 2020. In the full year and fourth quarter 2021, Morphic raised net proceeds of $25.7 million and $1.1 million from the use of our At-The Market (ATM) facility. To date in 2022, Morphic has not issued any stock through its ATM facility. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2021, will be sufficient to fund operating expenses and capital expenditure requirements until the end of 2024.

On February 24, 2022 MannKind Corporation (Nasdaq: MNKD) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Mannkind, FEB 24, 2022, View Source [SID1234608975]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We had a solid fourth quarter with Afrezza net revenue hitting a record $11.3 million and we ended the year with over $260 million in cash and investments on our balance sheet," said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation. "Although the extension of the Tyvaso DPI review is frustrating, our manufacturing team remains focused on producing pre-launch supplies of Tyvaso DPI for our collaboration partner, United Therapeutics."

Fourth Quarter 2021 Results

Total revenues were $12.5 million for the fourth quarter of 2021, reflecting Afrezza net revenue of $11.3 million and collaborations and services revenue of $1.2 million. Afrezza net revenue increased 13% compared to $10.1 million in the fourth quarter of 2020 as a result of higher demand, a more favorable cartridge mix, price, and lower gross-to-net deductions. Collaborations and services revenue decreased $7.2 million compared to the fourth quarter of 2020 due to a decrease in revenue recognized from the initial License Agreement with United Therapeutics ("UT"), which was substantially completed in the third quarter of 2021. Revenue associated with the commercial production of Tyvaso DPI was deferred in the fourth quarter of 2021 and will be recognized over the period when commercial product is sold to UT.

Afrezza gross profit for the fourth quarter of 2021 was $7.0 million compared to $6.4 million in the same period of 2020, an increase of $0.6 million, or 10%, which was driven by an increase in Afrezza sales, partially offset by an increase in cost of goods sold. Cost of goods sold increased by $0.6 million, or 18%, compared to the same period in 2020, primarily due to a $2.0 million increase in inventory write-offs partially offset by $1.8 million in reduced manufacturing-related spending. Afrezza gross margin in the fourth quarter of 2021 was 62% compared to 64% for the same period in 2020.

Cost of revenue – collaborations and services increased by $4.5 million in the fourth quarter compared to 2020 due to increased pre-approval manufacturing activity for Tyvaso DPI.

Research and development ("R&D") expenses for the fourth quarter of 2021 were $3.9 million compared to $1.5 million for the fourth quarter of 2020. This $2.4 million increase was mainly related to pre-clinical development of inhaled clofazimine as well as the Afrezza pediatrics clinical study (INHALE-1).

Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2021 were $22.7 million compared to $17.1 million for the fourth quarter of 2020. This $5.6 million increase was primarily attributable to higher Afrezza promotional expenses and patient support services as well as increased stock-based compensation.

For the fourth quarter of 2021, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $1.6 million compared to a loss of $4.0 million for the fourth quarter of 2020. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $1.4 million for the fourth quarter of 2021 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the fourth quarter of 2021 was $2.8 million compared to $2.4 million for the fourth quarter of 2020. This increase of $0.4 million was the result of interest on the $230.0 million 2.5% senior convertible notes issued in the first quarter of 2021, partially offset by a decrease in interest expense on Mann Group promissory notes as a result of (i) the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible note, (ii) the $10.0 million reduction of principal and interest on the Mann Group convertible note from a conversion to our common stock and (iii) a decrease of the interest rate from 7.00% to 2.50% on the remaining promissory note.

The net loss for the fourth quarter of 2021 was $28.1 million, or $0.11 per share, compared to $26.4 million in the fourth quarter of 2020, or $0.11 per share. The $1.7 million increase in the net loss was primarily due to a decrease in revenues from collaboration and services as well as increases in cost of revenue for collaborations and services and in SG&A expenses, partially offset by a gain on purchase commitment as well as the effect of the one-time acquisition of in-process R&D from QrumPharma in the fourth quarter of 2020.

Twelve Months Ended December 31, 2021

Total revenues were $75.4 million for the year ended December 31, 2021 reflecting Afrezza net revenue of $39.2 million and collaborations and services revenue of $36.3 million. Afrezza net revenue increased 21% compared to $32.3 million for the year ended December 31, 2020, primarily driven by higher demand, a more favorable cartridge mix, price, and lower gross-to-net deductions. Collaborations and services revenue increased $3.5 million compared to 2020 due to additional development work associated with our collaboration with UT.

Afrezza gross profit was $22.3 million for the year ended December 31, 2021, an increase of $5.1 million, or 30%, compared to a gross profit of $17.2 million in the prior year, which was attributable to an increase in Afrezza sales, partially offset by an increase in cost of goods sold. Cost of goods sold increased by $1.8 million, or 12%, for the year ended December 31, 2021 compared to the prior year, primarily due to a $2.0 million fee for the amendment of the Insulin Supply Agreement, a $1.5 million increase in inventory write-offs, and a $1.0 million increase related to reduced manufacturing activities. The increase in cost of goods sold was partially offset by $2.3 million in reduced manufacturing-related spending, lower per-unit cost from increased manufacturing efficiencies and the termination of a free goods program in December 31, 2020.

R&D expenses for the year ended December 31, 2021 were $12.3 million compared to $6.2 million for the prior year. This $6.1 million increase was primarily attributable to costs incurred to develop our product pipeline and to begin the Afrezza pediatrics clinical study (INHALE-1).

SG&A expenses for the year ended December 31, 2021 were $77.4 million compared to $59.0 million for the prior year. This $18.4 million increase was primarily attributable to higher Afrezza promotional expenses, patient support services, increased headcount and stock-based compensation and our voluntary reduction in compensation in the prior year in response to the COVID-19 pandemic.

For the year ended December 31, 2021, the gain on foreign currency translation (for insulin purchase commitments denominated in Euros) was $6.6 million compared to a loss of $8.0 million for the prior year. The fluctuation was due to a change in the U.S. dollar to Euro foreign currency exchange rate.

Interest expense on financing liability was $1.4 million for the year ended December 31, 2021 and represented interest incurred on the sale lease-back transaction for our manufacturing facility in Danbury, CT.

Interest expense on debt for the year ended December 31, 2021 was $15.2 million compared to $9.5 million for the prior year. This $5.7 million increase was primarily due to interest expense on the $230.0 million 2.5% senior convertible notes as well as a $3.7 million milestone obligation that was achieved during the first quarter of 2021, partially offset by a decrease in interest expense on Mann Group promissory notes as a result of (i) the repayment of $35.1 million of outstanding principal under the Mann Group non-convertible note, (ii) the $10.0 million reduction of principal and interest on the Mann Group convertible note from a conversion to our common stock and (iii) a decrease of the interest rate from 7.00% to 2.50% on the remaining promissory note.

The net loss for the year ended December 31, 2021 was $80.9 million, or $0.32 per share, compared to $57.2 million net loss for the year ended December 31, 2020, or $0.26 per share. The higher net loss was mainly attributable to the $22.1 million non-cash loss on extinguishment of the Mann Group convertible note net of a $4.9 million non-cash gain on extinguishment of the PPP loan, as well as an increase in SG&A expenses and in cost of revenue – collaboration and services, partially offset by an increase in Afrezza net revenues and revenues from collaboration and services, a gain on purchase commitment as well as the effect of the one-time acquisition of in-process R&D from QrumPharma in the prior year. On a non-GAAP basis, excluding the expense incurred for the loss on extinguishment of the Mann Group convertible note offset by the gain on extinguishment of the PPP loan, and the Amphastar amendment fee, the net loss for the year ended December 31, 2021 was $61.7 million, or $0.25 per share.

Cash, cash equivalents, restricted cash, and investments as of December 31, 2021 was $260.7 million compared to $67.2 million as of December 31, 2020. The increase was mainly due to the sale of senior convertible notes in the first quarter of 2021 for $230.0 million and the cash received from the sale-leaseback of our Danbury, CT manufacturing facility of approximately $100 million, offset by operating costs for 2021.

Non-GAAP Measures

To supplement our unaudited condensed consolidated financial statements presented under U.S. generally accepted accounting principles (GAAP), we are presenting certain non-GAAP financial measures. We are providing these non-GAAP financial measures to disclose additional information to facilitate the comparison of past and present operations, and they are among the indicators management uses as a basis for evaluating our financial performance. We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our unaudited condensed consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our non-GAAP financial measures. Likewise, we may determine to modify the nature of its adjustments to arrive at our non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by us in this report have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.

The following table reconciles our gross margin financial measure to a non-GAAP presentation as adjusted for the nonrecurring amendment fee related to an amendment to our Insulin Supply Agreement.

Conference Call

MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at mannkindcorp.com under Events & Presentations. A replay will be available on MannKind’s website for 14 days.